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14-OUT-159

Digestive Disease Institute

2013 Outcomes

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This project would not have been possible without the commitment and expertise of a team led by Dympna Kelly, MD; Laura Buccini, DrPH, MPH; and Charmaine Jones, MBA.

Graphic design and photography were provided by Cleveland Clinic’s Center for Medical Art and Photography.

© The Cleveland Clinic Foundation 2014

Measuring Outcomes Promotes Quality Improvement


Measuring and understanding outcomes of medical treatments promotes quality improvement. Cleveland Clinic has created a series of Outcomes books similar to this one for its clinical institutes. Designed for a physician audience, the Outcomes books contain a summary of many of our surgical and medical treatments, with data on patient volumes and outcomes and a review of new technologies and innovations.

The Outcomes books are not a comprehensive analysis of all treatments provided at Cleveland Clinic, and omission of a particular treatment does not necessarily mean we do not offer that treatment. When there are no recognized clinical outcome measures for a specific treatment, we may report process measures associated with improved outcomes. When process measures are unavailable, we may report volume measures; a relationship has been demonstrated between volume and improved outcomes for many treatments, particularly those involving surgical and procedural techniques.

In addition to these institute-based books of clinical outcomes, Cleveland Clinic supports transparent public reporting of healthcare quality data. The following reports are available to the public: • Joint Commission Performance Measurement Initiative (qualitycheck.org)

• Centers for Medicare and Medicaid Services (CMS) Hospital Compare (hospitalcompare.hhs.gov), and Physician Compare (medicare.gov/PhysicianCompare)

• Ohio Department of Health (ohiohospitalcompare.ohio.gov)

• Cleveland Clinic Quality Performance Report (clevelandclinic.org/QPR)

Our commitment to transparent reporting of accurate, timely information about patient care reflects Cleveland Clinic’s culture of continuous improvement and may help referring physicians make informed decisions.

We hope you find these data valuable, and we invite

your feedback. Please send your comments and

questions via email to:

[email protected] or scan here.

To view all our Outcomes books, please visit Cleveland Clinic’s Quality and Patient Safety Institute website at clevelandclinic.org/outcomes.

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Dear Colleague:

Welcome to this 2013 Cleveland Clinic Outcomes book. Every year, we publish Outcomes books for 14 clinical institutes with multiple specialty services. These publications are unique in healthcare. Each one provides a summary overview of medical or surgical trends, innovations, and clinical data for a particular specialty over the past year. We are pleased to make this information available.

Cleveland Clinic uses data to manage outcomes across the full continuum of care. Our unique organizational structure contributes to our success. Patient services at Cleveland Clinic are delivered through institutes, and each institute is based around a single disease or organ system. Institutes combine medical and surgical services, along with research and education, under unified leadership. Institutes define quality benchmarks for their specialty services, and report on longitudinal progress.

All Cleveland Clinic Outcomes books are available in print and online. Additional data are available through our online Quality Performance Report (clevelandclinic.org/QPR). The site offers process measure, outcome measure, and patient experience data in advance of national and state public reporting sites.

Our practice of releasing annual outcomes reports hasreceived favorable notice from colleagues and healthcare observers. We appreciate your interest and hope you find this information useful and informative.

Sincerely, Delos M. Cosgrove, MD CEO and President

Outcomes 2013

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3Digestive Disease Institute 3

Prefer an e-version?

Visit clevelandclinic.org/OutcomesOnline, and

we’ll remove you from the hard copy mailing list

and email you when next year’s books are online.

what’s inside

Chairman’s Letter 04

Institute Overview 05

Quality and Outcomes Measures

Procedure Overview – Digestive Disease Institute 06

Esophageal Disease 18

Small Bowel Disease and Intestinal Transplant 28

Nutrition 46

Large Bowel Disease 48

Trauma and Acute General Surgery 68

Pancreaticobiliary Disease 70

Liver Disease and Liver Transplant 76

Obesity 108

Breast Disease 118

Cleveland Clinic Florida 127

Institute Quality Improvement 140

Surgical Quality Improvement 146

Institute Patient Experience 148

Cleveland Clinic – Implementing Value-Based Care 150

Innovations 156

Contact Information 164

About Cleveland Clinic 166

Resources 168

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Chairman LetterChairman LetterChairman’s Letter

I am pleased to present the 2013 Outcomes book for Cleveland Clinic’s Digestive Disease Institute. This is the 12th year that we have shared our clinical outcomes and innovations with referring physicians, alumni, patients, and other individuals around the nation interested in digestive diseases. The book reflects our ongoing goal to provide patients with care of the highest quality and the deepest compassion.

This past year, our institute had many exciting achievements, including:

• Moving the Bariatric and Metabolic Center from the Endocrinology & Metabolism Institute to the Digestive Disease Institute. Under the leadership of Philip Schauer, MD, the program continues to expand and to be recognized as a leader in all aspects of bariatric surgery.

• Partnering with the Department of Thoracic Surgery and the Robert J. Tomsich Pathology & Laboratory Medicine Institute to create a new Center of Excellence for Barrett’s Esophagus. The center provides a multidisciplinary approach to the diagnosis and innovative management of Barrett’s dysplasia, a recognized risk factor for esophageal cancer.

• Performing the first liver and kidney transplants at our Weston, Fla., campus since the launch of the multiorgan transplant program in July 2013.

We welcome your feedback, questions, and ideas for collaboration. Please contact me via email at [email protected] and reference the Digestive Disease Institute book in your message.

Sincerely,

John Fung, MD, PhD Chairman, Digestive Disease Institute Medical Director, Allogen Laboratories Professor of Surgery, Lerner College of Medicine

Outcomes 20134

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Institute OverviewInstitute Overview

Cleveland Clinic Digestive Disease Institute is regarded as one of the top digestive disease centers in the nation and unites all specialists within one unique, fully integrated model of care aimed at optimizing the patient experience. Throughout the years, Digestive Disease Institute physicians have pioneered many new technologies and procedures for treating digestive disorders. This rich history of innovation continues today, whether through the development of new surgical techniques or participation in clinical trials and operating outcomes research databases or registries. U.S. News & World Report’s “Best Hospitals” survey has ranked the institute’s digestive disease services as No. 2 in the nation since 2003.

The institute is located on Cleveland Clinic’s main campus as well as 23 regional facilities and includes the departments of Gastroenterology and Hepatology, Colorectal Surgery and General Surgery (including hepato-pancreato-biliary, liver and intestinal transplant surgery and breast surgery); the Bariatric and Metabolic Center; and the Center for Human Nutrition. The institute’s 148 staff physicians, 138 residents and fellows, and 365 nurses offer the most advanced, safest and proven treatments performed in the most effective and patient-friendly way.

The Digestive Disease Institute staff authored

more than

450 publications

in 2013.

For a complete list, go to clevelandclinic.org/outcomes.

Evaluation & Management Visits 109,947

Locations 24

Research Studies 491

Publications 457

Presentations 590

Educational Events 134

Physicians 148

Inpatient Nurses 300

Ambulatory Nurses 65

Fellows 71

Residents 67

2013 Statistics

Digestive Disease Institute 5

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Surgical OverviewDigestive Disease Institute: Surgical Procedures

DDI Surgical Procedures: Inpatient/Outpatient 2011 – 2013

DDI Surgical Procedures: Inpatient/Outpatient, Practice Location 2011 – 2013

12,000

8000

0

N = 6045 7767 6342 9333 7125 10,470

4000

Number of Procedures

2011 2012 2013

InpatientOutpatient

6000

0

4000

2000


Cleveland ClinicMain Campus

Inpatient Outpatient

Cleveland ClinicCommunity Hospitals



2011 (N = 13,812)2012 (N = 15,675)2013 (N = 17,595)

Outcomes 20136

Procedure Overview-Digestive Disease Institute

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Breast Surgery: Procedures and Length of Stay Index

Breast Surgical Procedures 2011 – 2013

Breast Surgery: Volume and LOSa Indexb (N = 429) 2013

2000

1200

1600

800

0

N = 1384 1469 1789

400


2011 2012 2013

VolumeVolume LOS Index (O/E Ratio)

0

1.5

0.3

0.6

1.2

0.9

ClevelandClinicc

BA

Top U.S. Hospitals

C D00

500500

200200

300300

100100

400400

E F G H I

aLength of Stay; bSurgical procedures include other skin, subcutaneous tissue breast procedures with cc and without cc/mcc and mastectomies for malignancy with and without cc/mcc. cIncludes all Cleveland Clinic

O/E = observed (actual) length of stay/expected (predicted) length of stay based on severity of illness.

Source: These data are prepared using the University HealthSystem Consortium (UHC) Comparative Database, 2013 discharges. uhc.edu


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Bariatric Surgery: Procedures and Length of Stay Index

Bariatric Surgical Proceduresa: Inpatient/Outpatient 2011 – 2013

Bariatric Surgery: Minimally Invasive Procedures 2011 – 2013

aAll bariatric and nonbariatric surgical procedures performed by bariatric surgeons

800

400

600

0

N = 649 316 672 361 671 333

200


2011 2012 2013

InpatientOutpatient

920

840

880

800

760

N = 818 908 911


2011 2012 2013

Outcomes 20138


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Bariatric Surgery: Robotic Procedures 2011 – 2013

Bariatric Surgery: Volume and LOSa Indexb (N = 662) 2013

aLength of Stay; bSurgical procedures include other skin, subcutaneous tissue breast procedures with cc and without cc/mcc and mastectomies for malignancy with and without cc/mcc. cIncludes all Cleveland Clinic



80

40

60

20

0

N = 2 14 57


2011 2012 2013


0

1.6

0.8

1.2

ClevelandClinicc

BA

Top U.S. Hospitals

C D00

800800

200200

400400

600600

E F G H I

0.4


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Colorectal Surgery: Procedures, Mortality Index, and Length of Stay Index

Colorectal Surgical Procedures: Inpatient/Outpatient 2011 – 2013

Colorectal Surgical Procedures: Inpatient/Outpatient, Practice Location 2011 – 2013

4000

3000

0

N = 2107 1302 2175 1503 2511 1694

2000

1000


2011 2012 2013

InpatientOutpatient

2500

2000

0

1500

1000

500







2011 (N = 3409)2012 (N = 3658)2013 (N = 4205)

Outcomes 201310


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Colorectal Surgery: Minimally Invasive Procedures 2011 – 2013

Colorectal Surgery: Volume and In-Hospital Mortality Indexa (N = 2702) 2013

aSurgical procedures are defined as all major small/large bowel, minor small/large bowel, anal, and stomal procedures; rectal resection procedures; and other digestive system O.R. procedures.



800

400

600

200

0

N = 397 541 622


2011 2012 2013

VolumeVolume Mortality Index (O/E Ratio)

0

1.6

0.8

1.2

ClevelandClinic

BA

Top U.S. Hospitals

C D00

40004000

20002000

10001000

30003000

E F G H I

0.4


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Colorectal Surgery: Volume and LOSa Indexb (N = 2702) 2013

aLength of Stay; bSurgical procedures are defined as all major small/large bowel, minor small/large bowel, anal, and stomal procedures; rectal resection procedures; and other digestive system O.R. procedures. cIncludes all Cleveland Clinic




0

0.4

0.8

1.6

1.2

ClevelandClinicc

BA

Top U.S. Hospitals

C D00

40004000

10001000

20002000

30003000

E F G H I

Outcomes 201312


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General Surgery, Surgical Procedures: Inpatient/Outpatient 2011 – 2013

General Surgery, Surgical Procedures: Inpatient/Outpatient, Practice Location 2011 – 2013

General Surgery: Procedures, In-Hospital Mortality Index, and Length of Stay Index

8000

4000

6000

0

N = 3335 4901 3574 6101 4012 6702

2000


2011 2012 2013

InpatientOutpatient

4000

2000

3000

0

1000







2011 (N = 8236)2012 (N = 9675)2013 (N = 10,714)


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General Surgery: Minimally Invasive Procedures 2011 – 2013

General Surgery: Volume and In-Hospital Mortality Indexa (N = 1509) 2013

aSurgical procedures defined as all hernia, pancreas, and cholecystectomy procedures.

bIncludes all Cleveland Clinic community hospitals (with the exception of Cleveland Clinic Florida, Weston Campus)

O/E = observed (actual) length of stay/expected (predicted) length of stay based on severity of illness


5000

2000

3000

4000

1000

0

N = 3028 3590 4239


2011 2012 2013

VolumeVolume Mortality Index (O/E Ratio)

0

0.8

1.6

1.2

ClevelandClinicb

BA

Top U.S. Hospitals

C D00

16001600

800800

12001200

400400

E F G H I

0.4

Outcomes 201314


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aLength of Stay bSurgical procedures defined as all hernia, pancreas, and cholecystectomy procedures. cIncludes all Cleveland Clinic community hospitals (with the exception of Cleveland Clinic Florida, Weston Campus)

O/E = observed (actual) length of stay/expected (predicted) length of stay based on severity of illness


General Surgery: Volume and LOSa Indexb (N = 1509) 2013


0

0.8

1.2

1.6

ClevelandClinicc

BA

Top U.S. Hospitals

C D00

16001600

400400

800800

12001200

E F G H I

0.4


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Total Endoscopic Procedures 2011 – 2013

Colonoscopy and Esophagogastroduodenoscopy 2011 – 2013

Endoscopic OverviewDigestive Disease Institute: Endoscopic Procedures, All Providers

80,000

20,000

40,000

60,000

0

N = 47,974 48,324 61,072


2011 2012 2013

40,000

20,000

30,000

0

N = 24,400 16,540 30,915 18,783 32,519 20,397

10,000


2011 2012 2013

ColonoscopyEGDa

aEsophagogastroduodenoscopy

Outcomes 201316


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Endoscopic Retrograde Cholangiopancreatography and Endoscopic Ultrasound 2011 – 2013

Sigmoidoscopy/Ileoscopy/Enteroscopy/Pouchoscopy 2011 – 2013

aEndoscopic retrograde cholangiopancreatography bEndoscopic ultrasound

1600

800

1200

0

N = 1127 1275 1160 1389 1335 1531

400


2011 2012 2013

ERCPa

EUSb

2000

800

1600

1200

0

N = 1367 1254 1502 1321 1839 1443

400


2011 2012 2013

SigmoidoscopyIleoscopy/enteroscopy/pouchoscopy


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Diagnostic Procedures

Esophagogastroduodenoscopy (EGD) is used to diagnose disorders of the esophagus, stomach, and first part of the small intestine.

aPerformed by gastroenterology physicians

Esophagogastroduodenoscopiesa 2011 – 2013

Indications for Esophagogastroduodenoscopy 2011 – 2013

Cleveland Clinic’s Center for Swallowing and Esophageal Disorders features a multidisciplinary team that includes gastroenterologists; radiologists; thoracic surgeons; neurologists; lung specialists; swallowing therapists; and ear, nose, and throat specialists. The team sees nearly 2000 patients annually. The Center is one of very few in the nation offering comprehensive services, including specialized teams for nutrition therapy, intestinal rehabilitation, and nutrition support.

Indication Number Percent

Epigastric pain/abdominal pain/dyspepsia 5250 21

GERD/heartburn/Barrett’s esophagus 4418 17.5

GI bleeding/anemia 3416 13.5

Dysphagia/esophageal stricture/ulcer 3032 12

Nausea/vomiting/weight loss 1580 6

Establish/rule-out esophageal varices 1073 4

Other 6585 26

Total 25,354 100

20,000

15,000

0

N = 15,236 17,550 19,967

10,000

500


2011 2012 2013

Outcomes 201318

Esophageal Disease

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Barrett’s Esophagus

Digestive Disease Institute staff have partnered with staff in Thoracic Surgery and Pathology to create a Center of Excellence for Barrett’s esophagus. The center provides a multidisciplinary approach to the innovative management of Barrett’s esophagus, in particular the early diagnosis of esophageal adenocarcinoma. It also facilitates research collaboration among these disciplines.

Endoscopic Mucosal Resection

Endoscopic mucosal resection is a involving removal of the inner lining of the esophagus. The technique can be used for dysplasia (precancer) and some very early focal (single, small tumors) cancers of the esophagus. This procedure is not only used for therapeutic purposes, but it also provides tissue for staging esophageal cancer.

2011 – 2013

Upper GI Endoscopy in Patients With a Diagnosis of Barrett’s Esophagus 2011 – 2013

1000

800

0

N = 646 774 993

600

400

200


2011 2012 2013

60

0

N = 46 58 46

40

20


2011 2012 2013


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Radiofrequency ablation is a widely used procedure for treatment of dysplasia in Barrett’s esophagus. It is associated with high eradication rates — greater than 90% for dysplasia and greater than 80% for metaplasia. Patients will continue to require surveillance after successful eradication.

Radiofrequency Ablations 2011 – 2013

400

0

N = 206 238 331

200

300

100


2011 2012 2013

20 Outcomes 2013

Esophageal Disease

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Esophageal Motility and Reflux

The Center for Swallowing and Esophageal Disorders has one of the largest esophageal motility laboratories in the country. The center performs high-resolution manometry and pH studies including conventional 24-hour pH studies and 48-hour Bravo® pH capsule monitoring.

Manometry Studies 2011 – 2013

pH Studies 2011 – 2013

600

200

400

0

N = 476 148 492 217 502 216

Number of Studies

2011 2012 2013

24-hour pH48-hour Bravo

1000

400

600

800

0

N = 663 427 762 453 859 456

200

Number of Studies

2011 2012 2013

Esophageal manometry onlyEsophageal manometry with pH monitoring


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Hiatal Hernia Surgery

Hiatal hernia is a common disorder that results from a defect in the diaphragm, leading to herniation of the stomach into the chest cavity. These hernias are graded according to severity and are often associated with gastroesophageal reflux disease. For patients with significant symptoms, surgery may be indicated. Patients who are offered a minimally invasive approach — the standard of care at Cleveland Clinic — benefit from decreased pain, shorter length of stay, and better overall recovery.

Laparoscopic Hiatal Hernia Repair 2011 – 2013

Mean Length of Stay for Laparoscopic Hiatal Hernia Repair 2011 – 2013

80

0

N = 48 64 65

40

60

20


2011 2012 2013

5.4

3.8

N = 48 64 65

4.6

5.0

4.2

Days

2011 2012 2013

30-Day Readmission Rate for Laparoscopic Hiatal Hernia Repair 2011 – 2012

16

0

N = 48 64 65

8

12

4

Percent

2011 2012 2013

Outcomes 201322

Esophageal Disease

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Gastroparesis Surgery

Gastroparesis, also called delayed gastric emptying, is a disorder that slows the movement of food from the stomach to the small intestine. It often occurs in people with type 1 or type 2 diabetes. Treatment ranges from dietary changes and/or medications to surgery requiring the removal of most of the stomach and, more recently, the insertion of gastric neurostimulators.

Gastric Neurostimulator Surgery for Gastroparesis 2011 – 2013

Mean Length of Stay Post Neurostimulator Surgery 2011 – 2013

30

0

N = 6 18 25

20

10

Number of Patients

2011 2012 2013

4

0

N = 6 18 25

2

3

1

Days

2011 2012 2013

30-Day Readmission Rate Post Neurostimulator Surgery 2011 – 2013

16

0

N = 6

0

18 25

12

8

4

Percent

2011 2012 2013


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Median Arcuate Ligament Syndrome

Median arcuate ligament (MAL) syndrome, also known as celiac artery compression syndrome, is a rare diagnosis resulting in postprandial abdominal pain and weight loss. Cleveland Clinic has formed a collaborative team of gastroenterologists, minimally invasive surgeons, and vascular surgeons to evaluate and treat MAL syndrome. Treatment consists of releasing the MAL. Since 2010, the yearly volumes of MAL release have tripled. Likewise, conversion to open procedure has decreased from 25% to < 10%.

Median Arcuate Ligament Release Surgery 2010 – 2013

Conversion From Minimally Invasive to Open MAL Release Surgical Procedure 2012 – 2013

aBenchmark: Jimenez JC, Harlander-Locke M, Dutson EP. Open and laparoscopic treatment of median arcuate ligament syndrome. J Vasc Surg. 2012 Sep;56(3):869-873.

12

0

N = 6 5 12

9

6

3

Number of Surgeries

2011

4

2010 2012 2013

20

0

N = 5 12

15

10

5

Percent Conversion

2012 2013

CCFBenchmarka

Outcomes 201324

Esophageal Disease

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Mean Length of Stay for MAL Release Surgery 2010 – 2013

Celiac Artery Velocity (N = 14) 2010 – 2013

Decreased celiac artery velocity is a marker for successful release of the ligament and occurred in 85% of DDI’s patient population.

4

0

N = 6 5 12

3

2

1

Days

2011

4

2010 2012 2013

00

600600

400400

200200

Velocity (cm/s)Velocity (cm/s)

Preoperative Postoperative


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Esophageal Surgery Volume and Mortality

2009 – 2013

Cleveland Clinic thoracic surgeons performed 206 esophageal procedures in 2013. The in-hospital mortality rate was 0.9%.

The 1-year mortality rate following esophagectomy was 1.2% among patients who had surgery at Cleveland Clinic. The expected rate was higher (3.5%).

201220102009

Volume400400

300300

200200

100100

00

44

33

22

11

002011 2013

Mortality (%) Observed Expected

Esophagectomy Mortality 1 Year After Surgery

2013

4

Percent

3

2

0Expected

1

Observed

Source: These data are prepared using the University HealthSystem Consortium (UHC) Clinical Database. uhc.edu

Source: Society of Thoracic Surgeons (STS) National Adult Cardiac Surgery Database 2013.

Outcomes 201326

Esophageal Disease

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The majority of esophageal surgeries at Cleveland Clinic in 2013 were to treat patients with paraesophageal hernias and esophageal cancer.

Cleveland Clinic surgeons performed 149 esophageal surgeries from 2010 to 2013 with a risk-adjusted rate of morbidity and mortality better than the national median.

Risk-adjusted Standardized incidence Eligible procedures Unadjusted rate rate (95% CI) ratio (95% CI)

149 25.5% 27.6% (20.5%-33.1%) 0.94 (0.73-1.17)

Distribution of Esophageal Surgeries by Indication (N = 206)

Combined Morbidity/Mortality for Esophagectomy for Esophageal Cancer, July 2010 – June 2013

2013

33% Cancer (N = 68)33% Cancer (N = 68)

3% Reflux (N = 6)3% Reflux (N = 6)

20% Achalasia (N = 41)20% Achalasia (N = 41)7% Other (N = 14)7% Other (N = 14)

34% Paraesophageal hernia repair (N = 71)34% Paraesophageal hernia repair (N = 71)

3% Esophageal reconstruction (N = 6)3% Esophageal reconstruction (N = 6)

100%100%

Min0.45

25th0.94

Cleveland Clinic

Median1.02

75th1.17

Max1.70

= STS standardized incidence ratio Source: STS General Thoracic Surgery Database, July 2010–June 2013.


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Antegrade Balloon-Assisted Enteroscopy 2011 – 2013

Retrograde Balloon-Assisted Enteroscopy 2011 – 2013


The Digestive Disease Institute has an active device-assisted enteroscopy program and performs procedures for indications including obscure gastrointestinal bleeding, abnormal capsule endoscopy imaging, small bowel tumors, intestinal obstruction, and inflammatory bowel disease.

120

90

0

N = 56 74 113

60

30

Number

2011 2012 2013

160

120

0

N = 155 156 126

80

40

Number

2011 2012 2013

Outcomes 201328

Small Bowel Disease and Intestinal Transplant

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SmartPill 2011 – 2013

Video Capsule 2012 – 2013

The institute’s Center for Capsule Endoscopy has extensive experience with the SmartPill®, a novel ingestible medical device that assesses pressure, acid levels, and motility of the entire gastrointestinal tract.

The Center for Capsule Endoscopy also uses video capsules, an innovative method to detect and diagnose lesions of the small bowel in patients with suspected GI tract bleeding, inflammatory bowel disease, polyps, and masses.

60

0

N = 25 30 55

40

20


2011 2012 2013

600

0

N = 343 566 513

400

200


2011 2012 2013

Remote Video Capsule Reads 2011 – 2013

The Center for Capsule Endoscopy implemented InteleCap, a distance medicine initiative that provides external centers with remote interpretation of their capsule endoscopy videos by a board-certified gastroenterologist.

120

0

N = 27 105

90

60

30


2012 2013


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Inflammatory Bowel Disease Outpatient Visits 2011 – 2013

Center for Inflammatory Bowel Disease

Cleveland Clinic has an international reputation for excellence in treating inflammatory bowel disease (IBD), which includes Crohn’s disease and ulcerative colitis. Over the years, its physicians have pioneered new technologies and procedures for treating IBD.

6400

5200

N = 5561 5928 6236

60006200

5800

56005400

Number

2011 2012 2013

30 Outcomes 2013


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Infliximab Infusionsa 2011 – 2013

Crohn’s Disease Medical Management

Treatment for Crohn’s disease is determined by severity and location. When Crohn’s disease is active, treatment is aimed at controlling inflammation, correcting nutritional deficiencies, and relieving symptoms such as pain, diarrhea, and fever. Infliximab (Remicade®) is approved specifically for the treatment of moderate to severe Crohn’s disease and for patients who are unresponsive to other treatments.

During the past 3 years, the number of infliximab infusions performed at Cleveland Clinic has increased, reflecting growing disease severity among Cleveland Clinic’s patient population.

aInfliximab is used to treat ulcerative colitis as well, but most infliximab use (95%) is for the treatment of Crohn’s disease.

1200

0

N = 937 981 1053

900

600

300

Number of Infusions

2011 2012 2013


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Crohn’s Disease Surgical Cases 2011 – 2013

Surgical Management

The surgical volume for Crohn’s disease is high with a particular focus on techniques that conserve the small bowel. The multidisciplinary team includes surgeons, gastroenterologists, nutritionists, pathologists, and radiologists.

Crohn’s Disease Postoperative Outcomes 2011 – 2013

2011 2012 2013

Open Lapa Open Lap Open Lap Postoperative Outcomes (N = 295) (N = 51) (N = 296) (N = 60) (N = 295) (N = 82)

Median length of stay, days 9 7 9 7 8 7

30-day readmission rate 16% 18% 10% 8% 11% 20%

In-hospital mortality rate 2% 0% 0% 0% 0% 0%

Surgical site infection rate Superficial 7% 4% 5% 3% 7% 5% Deep 1% 0% 1% 0% 1% 0% Organ space 4% 12% 9% 8% 8% 5%

Urinary tract infection rate 3% 2% 3% 7% 2% 1%

Venous thromboembolism rate 4% 2% 4% 3% 4% 2%aLaparoscopic

300

100

200

0

N = 51 60 82295 296 295

Number of Surgeries

2011 2012 2013

LaparoscopicOpen

Outcomes 201332


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Continent Ileostomy Volume 2011 – 2013

Continent Ileostomy

Cleveland Clinic’s Department of Colorectal Surgery is one of the few sites in the world that performs this procedure. The continent ileostomy is an internal reservoir that allows patients to avoid wearing an external stomal appliance. The pouch is emptied by inserting a soft catheter through the stoma. A continent ileostomy can be constructed from an existing end ileostomy and, in some cases, from failed pelvic J pouches.

60

0

N = 16 49

40

20

Number

Creation Revision

33Digestive Disease Institute

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34

Small Bowel Obstruction Patients (Operative and Nonoperative) 2011 – 2013

Mean Length of Stay of Small Bowel Obstruction Inpatients (Operative and Nonoperative) 2011 – 2013

Small Bowel Obstruction

Mechanical small-bowel obstruction (SBO) is the most frequently encountered surgical disorder of the small intestine. Cleveland Clinic’s annual SBO admissions have increased over the last 3 years. The section of Acute Care Surgery is developing an SBO clinical care path that will standardize nonoperative and operative SBO management.

300

100

200

0

N = 183 57 234 84 241 96

Number of Patients

2011 2012 2013

OperativeNonoperative

20

10

5

15

0

N = 183 57 234 84 241 96

Days

2011 2012 2013


Outcomes 201334


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30-Day Readmission Rate of Small Bowel Obstruction, Inpatients (Operative and Nonoperative) 2011 – 2013

30

10

20

0

N = 183 57 234 84 241 96

Percent

2011 2012 2013



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Patients Undergoing HIPECa Procedure 2010 – 2013

Management of Carcinomatosis

Hyperthermic intraoperative peritoneal chemotherapy (HIPEC) is a surgical procedure used to treat cancers that have spread to the lining of the abdominal cavity, such as cancers arising in the appendix, colon, stomach, ovaries, and pseudomyxoma peritonei and peritoneal mesothelioma. This is a two-step surgical procedure, which includes debulking of visible disease (tumor), followed by HIPEC. HIPEC delivers heated chemotherapy directly into the abdomen, which circulates for 90 minutes treating the microscopic disease that may remain.

aHyperthermic intraoperative peritoneal chemotherapy

30

20

0

N = 23 12 14

10


2011

21

2010 2012 2013

Mean Length of Stay for HIPECa Patients 2010 – 2013

16

12

0

N = 23 12 14

8

4

Days

2011

21

2010 2012 2013

Outcomes 201336


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Cancer Type for Patients Undergoing HIPECa Procedure (N = 70) 2010 – 2013

aHyperthermic intraoperative peritoneal chemotherapy

Cancer Type Patients Percent

Colon cancer 18 25.7

Appendix carcinoma 14 20.0

Pseudomyxoma peritonei 7 10.0

Ovarian cancer 6 8.6

Peritoneal mesothelioma 6 8.6

Gastric cancer 3 4.3

Peritoneal carcinomatosis 3 4.3

Retroperitoneal cancer 3 4.3

Undefined 2 2.9

Cancer Type Patients Percent

Adenocarcinoma unknown primary 1 1.4

Breast carcinoma 1 1.4

Cervical cancer 1 1.4

Desmoplastic round cell tumor 1 1.4

Gall bladder cancer 1 1.4

Lung cancer 1 1.4

Small bowel cancer 1 1.4

Uterine cancer 1 1.4


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Inguinal and Incisional/Ventral Hernia Repairs 2011 – 2013

Inguinal Hernia Repairs: Open and Laparoscopic 2011 – 2013

Hernia Center

Surgeons from Cleveland Clinic’s Hernia Center perform more than 1700 hernia repairs each year, from the routine to the most complex cases. The center is designed so that patients receive individualized care, undergoing a comprehensive evaluation to determine the best surgical procedure for their specific type of hernia.

1000

600

400

200

800

0

N = 884 397 927 397 960 518

Number of Repairs

2011 2012 2013

OpenLaparoscopic

1600

800

400

1200

0

N = 1281 579 1324 655 1478 665

Number of Repairs

2011 2012 2013

InguinalIncisional/ventral

Outcomes 201338


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Incisional/Ventral Hernia Repairs: Open and Laparoscopic 2011 – 2013

500

300

200

100

400

0

N = 411 168 471 184 472 193

Number of Repairs

2011 2012 2013

OpenLaparoscopic


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40

Mean Length of Stay, Inpatient Incisional/Ventral Hernia Repairs: Open and Laparoscopic 2011 – 2013

5

3

4

2

1

0

N = 411 168 471 184 472 193

Days

2011 2012 2013

OpenLaparoscopic

Mean Length of Stay of Inpatient Inguinal Hernia Repairs: Open and Laparoscopic 2011 – 2013

6

43

5

21

0

N = 884 397 927 397 960 518

Days

2011 2012 2013

OpenLaparoscopic

Outcomes 201340


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41

Reoperation Rate, Post Hernia Repair: Open and Laparoscopic 2011 – 2013

2011 (N) 2012 (N) 2013 (N)

Inguinal

Open 0.34% (3/884) 0.32% (3/927) 0.00% (0/960) Laparoscopic 0.00% (0/397) 0.00% (0/397) 0.00% (0/518)

Incisional/Ventral

Open 2.68% (11/411) 0.85% (4/471) 0.21% (1/472) Laparoscopic 0.59% (1/168) 0.54% (1/184) 0.00% (0/193)


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Total CGRT Clinical Activities 2011 – 2013

Center for Gut Rehabilitation and Transplantation

The Center for Gut Rehabilitation and Transplantation (CGRT) was established as a continuation of Cleveland Clinic’s efforts to enhance the multidisciplinary team approach for the management of patients with acute and chronic gut failure and complex abdominal pathology. The Intestinal Stroke Team (gut rehabilitation surgeons, infectious disease specialists, nutritionists, gastroenterologists, intestinal stroke surgeons, pharmacists, radiologists, nurses, social workers, and intensive care specialists) accepts all patients with acute intestinal ischemia with the intent to restore blood flow to the intestine and other abdominal organs utilizing combined radiologic and surgical techniques. With the recent inception of the Intestinal Stroke Program most patients were rescued with preservation of the gut organs that were viable on referral.

Referrals have grown exponentially due to medical and surgical rehabilitative efforts including visceral transplantation.

120

80

0

60

40

20


100

300

200

0

150

100

50

250

2011 2012 2013

N = 2 18 106

Gut rehabilitation surgeryVisceral transplantation

Candidates referred

Procedures

Referrals

Number of Referrals

Outcomes 201342


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43

Nontransplant Intestinal Reconstruction (N = 98) 2013

The most commonly utilized surgical rehabilitation includes autologous reconstruction alone or combined with a bowel lengthening procedure. Gastric reconstruction with restoration of gut continuity has been increasingly required for patients who previously had gastric bypass surgery at other centers and subsequently developed intestinal failure after a catastrophic abdominal event.

Fifty-six percent of patients undergoing intestinal surgical rehabilitation achieved nutritional autonomy with discontinuation of home parenteral nutrition. The remaining patients underwent continual gut rehabilitation with the recently FDA-approved agent Gattex® (teduglutide) or received intestinal transplantation.

Bowel Lengthening With Serial Transverse Enteroplasty Procedure

80

60

0

40

20

Percent

Autologous IntestinalReconstruction

(Intention to Treat)

Bowel LengtheningProcedure

Foregut GastricReconstruction


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44

Visceral Transplant Procedures (N = 9) 2013

Types of Intestinal Transplant

aThe liver-intestine-pancreas recipient was a child who had Martinez-Frias syndrome, a rare hereditary disorder with neonatal diabetes, enterocyte failure, and end stage liver disease

Intestine alone Multivisceral (liver, intestine,

duodenum, pancreas)

Full multivisceral Multivisceral without liver

10

4

6

8

0

2

NumberIntestine aloneLiver, intestine, and pancreasa

Full multivisceral

Outcomes 201344


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Intestinal Transplant Patient Survivala (N = 9) 2013

Intestinal Transplant Patient Survival Compared With National Benchmark 2013

Intestinal Transplant Graft Survivala (N = 9) 2013

aThe first case of intestinal transplant was performed in July 2013. Last follow-up date was April 25, 2014.

Source: Based on data available as of April 25, 2014, released at SRTR.org

aThe first case of intestinal transplant was performed in July 2013. Last follow-up date was April 25, 2014.

00

100100

4040

6060

8080

2020

Percent SurvivalPercent Survival

100 200150Days After Transplantation

250 30000

100100

4040

6060

8080

2020


50 150100Days After Transplantation

200 300250

100

0

N = 9

80

60

40

20

Percent Survival

Benchmark


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46

The Center for Human Nutrition provides evaluation, education, and treatment for disease-related nutrition problems as well as preventive, sports, and wellness counseling. Specialty focus nutrition teams work closely with healthcare providers in the Center for Gut Rehabilitation and Transplantation to support the nutrition needs of critically ill, organ transplant, and severe gastrointestinal failure patients. The goals of the center include intensive diet counseling, tube feeding, and oral rehydration techniques, along with medication, growth factor therapy, and restorative surgery.

To support the continuum of care, hospital to home, the Center for Human Nutrition maintains outpatient services and clinics throughout a five-county area. Significant growth in the number of patients referred for outpatient consultation was observed in 2013, especially those referred from the Cleveland Clinic Employee Health Plan. Successful implementation of MyConsult, an online nutrition service, helped accommodate the increased number of outpatient referrals in 2013.

Nutrition Service Volume 2011 – 2013

Inpatient Services 2011 2012 2013

Hospital parenteral nutrition patients 1585 1823 1833

New home total parenteral nutrition patients 197 274 290

Small-bowel feeding tube placement consults 2570 2222 1811

Feeding tubes placed 1754 1542 1194

Home enteral nutrition patients trained 397 368 374

Outpatient Services 2011 2012 2013

Center for Gut Rehabilitation and Transplantation Clinic patients 446 492 590

Outpatient clinic consultations 16,662 16,680 17,523

Eat Right at School Programa (no. of schools) 15 58 146

Employee health planb consultations 1433 2368 3050

MyConsult Nutritionc consultations 0 0 396

aEat Right at School was developed in 2011 by members of Outpatient Nutrition Therapy in collaboration with Cleveland Clinic’s Public Health and Research team. Eat Right at School provides an award to schools that meet specific nutrition criteria (reduced fat, sugar, and salt, and increased fruits, vegetables, and fiber) that surpass the current USDA National School Lunch and National School Breakfast Programs.

bCleveland Clinic Employee Health Plan participants who receive weight reduction, hyperlipidemia, diabetes, or hypertension counseling

cOnline nutrition consult services for employees, consumers, and corporate clients

Outcomes 201346

Nutrition

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Readmissions for New Patients Discharged on Home Parenteral Nutrition 2011 – 2013

Complications of Home Parenteral Nutrition-Related Readmissions 2011 – 2013

Home parenteral nutrition (HPN) frequently results in hospital readmission. In 2013, a 4% increase from 2012 was observed in the number of patients readmitted due to complications of HPN. The most common reasons for readmissions were CRBSI and other complications including noninfectious catheter complications, electrolyte disturbances, and venous thrombosis.

aCRBSI = catheter-related bloodstream infection bHPN = home parenteral nutrition cTotal number of new home parenteral nutrition patients

aTotal number of new home parenteral nutrition patients

Nutritional Assessment of Patients With Pressure Ulcers by Degree of Malnutrition Identified (N = 44) 2013

A sample of hospitalized patients with stage 2 or greater pressure ulcers were assessed for malnourishment. Twenty-five percent of patients were not found to be malnourished, while 35% were severely malnourished, 13% moderately malnourished, and 27% mildly malnourished.

40

0

30

20

10

Percent

SevereMalnutrition

ModerateMalnutrition

MildMalnutrition

NoMalnutrition

Identified

60

4050

0

Na = 197 274 290

30

20

10

Percent

2011 2012 2013

20

0

Nc = 197 274 290

15

10

5

Percent

2011 2012 2013

CRBSIa

DehydrationOther HPNb reasons

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48

2011 – 2013

Colonoscopy Complication Rate 2011 – 2013

Cecal Intubation Rate for Colonoscopy 2011 – 2013

*Benchmark: Lieberman DA, Rex DK, Winawer SJ, Giardiello FM, Johnson DA, Levin TR; United States Multi-Society Task Force on Colorectal Cancer. Guidelines for colonoscopy surveillance after screening and polypectomy: A consensus update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2012 Sep;143(3):844-857. aTotal number of colonoscopies


Colonoscopy Colonoscopy is an outpatient procedure commonly used to evaluate gastrointestinal symptoms or as a screening for colorectal polyps or cancer.

28,000

22,000

10,000

N = 21,465 26,397 27,925

16,000

Number Performed

2011 2012 2013

10

6

8

0

2

4

Rate/10,000 Procedures

2011 2012 2013

Cleveland ClinicBenchmark*

100

60

80

0

20

40

Percent

2011 2012 2013

Na = 21,465 26,397 27,925

Outcomes 201348

Large Bowel Disease

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49

Scope Withdrawal Time for Colonoscopya 2011 – 2013

Polyp Detection Rate During Colonoscopy 2011 – 2013

Flexible Sigmoidoscopy 2011 – 2013

*Benchmark: Lieberman DA, Rex DK, Winawer SJ, Giardiello FM, Johnson DA, Levin TR; United States Multi-Society Task Force on Colorectal Cancer.Guidelines for colonoscopy surveillance after screening and polypectomy: A consensus update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2012 Sep;143(3):844-857.

Cleveland Clinic scope withdrawal times consistently exceed the national benchmark.

aIn pilot endoscopy areas where withdrawal time is measured

aTotal number of colonoscopies

With maneuversNo maneuversBenchmark*

12

9

0

3

6

Minutes

2011 2012 2013

N = 2200 1776 4010 2941 9854 6774

40

20

30

0

Na = 21,465 26,397 27,925

10

Percent

2011 2012 2013

1600

1200

1400

800

N = 1223 1368 1590

1000


2011 2012 2013


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50

Colon Cancer Surgical Cases 2011 – 2013

In 2013, more than 200 patients underwent surgery for tumors of the colon by the Department of Colorectal Surgery. Despite increasing patient acuity (average American Society of Anesthesiology score 2.9), surgeons in the Department of Colorectal Surgery achieved a 30-day mortality rate of 0% and the average lymph node harvest remained almost three times higher than the 12-node minimum that has become a national benchmark for quality of surgery and pathology assessment.

Colon and Rectal Cancer

Cancer of the colon and rectum is the fourth most common type of cancer in the U.S., affecting over 136,000 patients annually.

Multidisciplinary Tumor Conference

Patients with colorectal

cancer are reviewed by a

multidisciplinary tumor

board consisting of caregivers

from anatomic pathology,

colorectal surgery, medical

oncology, radiation oncology,

gastroenterology, genomic

medicine, hepatobiliary surgery,

and radiology.

During Tumor Board, patients’

pathology and radiologic images

are reviewed for diagnosis and

clinical staging; a treatment plan

is then formulated.

120

40

80

0

N= 29 99 104 104 98 108

Number of Surgical Cases

2011 2012 2013

LaparoscopicOpen

Outcomes 201350

Large Bowel Disease

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Postoperative Outcomes 2011 2012 2013

Open Lapa Open Lap Open Lap

N = 99 29 104 104 108 98

Lymph nodes harvestedb (mean) 39.5 34 39 34.5 33.5 30

ASAc scored (mean) 2.8 2.8 2.9 2.8 2.9 2.8

Median length of stay (days) 10 8 11 8 9 8



Surgical site infection rate

Superficial 5% 3% 5% 4% 6% 8%

Deep 0% 0% 0% 0% 1% 0%

Organ space 6% 7% 11% 3% 9% 3%


Venous thromboembolism rate 2% 0% 8% 5% 4% 3%

aLaparoscopic bLymph nodes harvested — The American Joint Committee on Cancer (AJCC) and a National Cancer Institute (NCI) recommend harvesting for examination at least 12 lymph nodes in patients with colon cancer to confirm the absence of nodal involvement by tumor. cAmerican Society of Anesthesiologists dASA score is a subjective assessment of a patient’s severity of illness based on five classes (1-5) where 1 represents a completely healthy/fit patient and 5 represents a moribund patient not expected to live more than 24 hours.

Colon Cancer Postoperative Outcomes 2011 – 2013


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Disease-Free Colon Cancer Survival by Stage 1978 – 2012

Stage-specific, 5-year disease-free survival rates for Cleveland Clinic-treated patients with colon cancer continue to exceed national averages: stage 1 = 74%, stage 2 = 59%, stage 3 = 46%, and stage 4 = 6%.

Rectal Cancer Surgical Cases

Achieving high-quality outcomes in patients with rectal cancer requires a committed and multidisciplinary team of specialist surgeons, medical and radiation oncologists, pathologists, and radiologists. Cleveland Clinic’s Rectal Cancer Multidisciplinary Team meets weekly to construct an individualized treatment plan for each newly referred patient.

2011 – 2013

150

50

100

0

N = 19 137 31 134 47 126

Number

2011 2012 2013

LaparoscopicOpen

00

100100

4040

6060

8080

2020


0 4020Months After Surgery

60

Stage 1 (N = 1007)Stage 2 (N = 1514)Stage 3 (N = 1117)Stage 4 (N = 748)

Outcomes 201352

Large Bowel Disease

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N = 137 19 134 31 126 47

ASAb scorec (mean) 2.7 2.5 2.9 2.7 2.8 2.7




Surgical site infection rate

Superficial 9% 0% 9% 0% 5% 2%

Deep 0% 0% 1% 0% 0% 0%

Organ space 5% 0% 10% 13% 8% 4%



aLaparoscopic bAmerican Society of Anesthesiologists cASA score is a subjective assessment of a patient’s severity of illness based on five classes (1-5) where 1 represents a completely healthy/fit patient and 5 represents a moribund patient not expected to live more than 24 hours.

Rectal Cancer Postoperative Outcomes 2011 – 2013


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Disease-Free Rectal Cancer Survival by Stage 1978 – 2012

Stage-specific, 5-year, disease-free survival rates for Cleveland Clinic-treated patients with rectal cancer continue to exceed national averages: stage 1 = 74%, stage 2 = 52%, stage 3 = 45%, and stage 4 = 6%.

00

100100

4040

6060

8080

2020


0 4020Months After Surgery

60

Stage 1 (N = 1666)Stage 2 (N = 995)Stage 3 (N = 1348)Stage 4 (N = 600)

Outcomes 201354

Large Bowel Disease

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Weiss Center Registry Families Enrolled for Familial Adenomatous Polyposis and Hereditary Nonpolyposis Colorectal Cancer 2010 – 2013

The Weiss Center and the Digestive Disease Institute conduct multidisciplinary clinics that care for patients who are at high risk for developing colorectal and other cancers due to their syndromes. Specialties staffing the clinics include gastroenterology for evaluation of the stomach and small intestine, gynecology for uterine and ovarian screening, endocrinology for thyroid evaluation, urology for screening of the urinary tract, and dermatology for potential skin neoplasms. Biweekly clinics are held for patients with familial adenomatous polyposis and other polyposis syndromes, and monthly clinics for patients and families with hereditary nonpolyposis colorectal cancer.

Hereditary Colon Cancer

The Sanford R. Weiss, MD, Center for Hereditary Colorectal Neoplasia was established in 2008. It is staffed by a multidisciplinary team dedicated to the care of patients with or at risk for hereditary colorectal cancer syndromes. It houses the David G. Jagelman Inherited Colon Cancer Registries, which were established in 1979. The mission of the Jagelman Registry and the Weiss Center is to prevent death from colorectal cancer or cancer of other organs involved in these syndromes by excellent patient care, effective education, and clinically relevant research.

2000

0

N = 1735 1849 1952

1500

1000

500

Cumulative Number

2011

1668

2010 2012 2013


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Consults Conducted on Enrolled Weiss Center Patients 2011 – 2013

Procedures Performed on Weiss Center Registry Patients 2011 – 2013

400

300

0

200

100

Number of Consults

Gastroenterology Consult Surgical Consult

201120122013

N = 46 62 110 124 293 300

400

300

0

200

100


Thyroid/RenalUltrasound

EGD Sigmoidoscopy Colonoscopy

201120122013

N = 91 160 199 163 192 294 217 210 229 214 198 300

Outcomes 201356

Large Bowel Disease

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Families Treated by the Weiss Center for Less Common Polyposis Syndromes (N = 1287)

In addition to treating patients with hereditary nonpolyposis colorectal cancer and familial adenomatous polyposis syndromes, the Weiss Center cares for patients and families with other less common hereditary syndromes associated with a high risk for colorectal and other cancers. These include Peutz-Jeghers syndrome, juvenile polyposis syndrome, MYH-associated polyposis, and serrated polyposis syndrome.

2010 – 2013

200

150

0

100

50

Number Treated

2010 2011 2012 2013

Peutz-Jeghers syndromeJuvenile polyposis syndromeMYH-associated polyposisOthera

Serrated polyposis syndrome

aIncludes Cowden syndrome, Cronkhite-Canada syndrome, and oligopolyposis


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Genetic Counseling

Cleveland Clinic is committed to identifying patients who may have Lynch syndrome by a routine screening process of patient tissues. Lynch syndrome, often called hereditary nonpolyposis colorectal cancer (HNPCC), is an inherited condition that causes an increased risk for colorectal cancer, endometrial cancer, stomach cancer, ovarian cancer, and cancer in certain other organs.

The Digestive Disease Institute, Genomic Medicine Institute, Pathology and Laboratory Medicine Institute, and Ob/Gyn & Women’s Health Institute have collaborated to screen all colorectal and endometrial cancers that are surgically removed at Cleveland Clinic for Lynch syndrome. Cleveland Clinic has been testing for Lynch syndrome since 2004.

2013

475 patients surgically resected colorectal cancer

screened by MSI/IHCa

450 patients did not require further evaluation

12 patients did not have genetic counseling

Five patients had no significant findings

25 patients required further evaluation for

Lynch syndrome

13 patients underwent genetic counseling

Eight patientsb were found to have Lynch syndrome

amicrosatellite instability/immunohistochemistry bOn average, each of these patients has three relatives who will also have Lynch syndrome.

Outcomes 201358

Large Bowel Disease

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Surgical Management of Ulcerative Colitis 2011 – 2013

Collaborative efforts to enhance quality have resulted in consistently low surgical site infection and readmission rates.

Ulcerative Colitis

Cleveland Clinic is a referral center for patients diagnosed with ulcerative colitis. Minimally invasive laparoscopic surgical approaches, J pouches, and salvaging problematic J pouches are available for those patients requiring surgery.

400

200

100

300

0

N = 82 267 142 315 116 326


2011 2012 2013

LaparoscopicOpen



N = 267 82 315 142 326 116




Surgical site infection rates

Superficial 7% 5% 5% 6% 4% 7%

Deep 0% 0% 0% 0% 0% 0%

Organ space 5% 13% 9% 8% 5% 6%



alaparoscopic

Ulcerative Colitis Postoperative Outcomes 2011 – 2013


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Center for Ileal Pouch Disorders

Cleveland Clinic is one of the highest volume centers in the US for ileal J pouch surgery in the treatment of ulcerative colitis and familial adenomatous polyposis. For more than 3 decades, Cleveland Clinic has offered restorative proctocolectomy with ileal J pouch surgery as an alternative to permanent stoma, with successful outcomes and improved quality of life for thousands of patients.

The Center for Ileal Pouch Disorders is a major referral center for dysfunctional ileal J pouches. It was the first of its kind established to treat pouch disorders and remains on the cutting edge in new approaches to the management of pouch complications.

Surgical Pouch Construction 2013

The Ileal Pouch Center is the world’s first and largest multidisciplinary pouch center and sees more than 1200 patients each year.

Pouch disorders are classified and managed based on the following categories:

• Surgical/mechanical

• Inflammatory/infectious

• Functional

• Neoplastic

• Systemic/metabolic

150

140

100

N = 144 140 145

130

120

110


2011 2012 2013

Outcomes 201360

Large Bowel Disease

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Complete Healing Rate of Pouch Sinus Using Endoscopic Needle Knife Therapy

Cleveland Clinic gastroenterologists have developed a novel needle knife technique to treat pouch complications such as the formation of sinuses, anastomotic leaks, and chronic abscesses. The technique uses a Doppler-ultrasound needle knife to perform sinusotomy to drain the sinus cavity and is a less invasive alternative to multistage surgical intervention. The Digestive Disease Institute is the only medical center in the US that treats pouch sinus using this technique.

2012 – 2013

Pouchoscopy

A pouchoscopy is an endoscopic exam performed on patients who have undergone a total proctocolectomy with ileal pouch anal anastomosis. It is recommended that this be done annually to examine and biopsy the pouch (small bowel) and the anal transitional zone to rule out dysplasia. The exam can also reveal other problems, such as pouchitis, polyps, and ischemia, while allowing patients to continue their healthy living with a pouch.

2011 – 2013

aTotal number of endoscopic needle-knife procedures

50

40

0

Na = 69 81

30

20

10

Percent

2012 2013

1400

1300

1000

N = 1232 1257 1324

1200

1100


2011 2012 2013


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Diverticulitis

Diverticulitis is a condition resulting from inflammation and infection in one or more diverticula. Surgery becomes necessary when antibiotics fail to eradicate the infection, and when a large abscess, perforation, peritonitis or continued rectal bleeding is present.

The percentage of diverticulitis surgical cases that were completed via a minimally invasive laparoscopic approach increased over the past 3 years. The colorectal department has a national and international referral base particularly for highly complex cases.

Surgical Management of Diverticulitis 2011 – 2013

150

90

60

30

120

0

N = 69 93 113 76 132 80

Number of Surgeries

2011 2012 2013

LaparoscopicOpen

Outcomes 201362

Large Bowel Disease

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N = 93 69 76 113 80 132




Surgical site infection rates

Superficial 9% 4% 7% 4% 16% 5 Deep 1% 0% 0% 1% 0% 0% Organ space 5% 3% 7% 14% 11% 3%



alaparoscopic

Diverticulitis Postoperative Outcomes 2011 – 2013


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Stoma Therapy

Some bowel diversion/ostomy surgeries divert the bowel to an opening in the abdomen where a stoma is created.

The Digestive Disease Institute has an active Wound Ostomy Care (WOC) program that helps patients with the practical, social, and psychological issues related to bowel diversion. WOC nurses are board-certified by their professional organization and care for patients each day in the inpatient setting and outpatient clinic.

Cleveland Clinic’s R.B. Turnbull, Jr., MD, Wound, Ostomy, Continence Nursing (WOCN) Program was established as the first WOCN school in the world 50 years ago.

The program prepares nurses to:

• Manage ostomies pre- and postoperatively

• Prevent and treat pressure ulcers, fistula, and other skin disorders

• Care for patients with urinary and fecal incontinence

More than 3000 WOCN specialists have

graduated from the program and are

practicing throughout the world.

Total Inpatient and Outpatient Visits 2013

12,000

9000

0

N = 11,544 3813

6000

3000

Number of Patient Visits


Outcomes 201364

Large Bowel Disease

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Pelvic Floor Disorders The pelvic floor team is a multidisciplinary group of physicians with an emphasis on female pelvic floor disorders and is one of the most experienced groups of such specialists in the region. Specialists treat the entire spectrum of bowel disorders, including fecal incontinence, chronic constipation, and other difficulties. They also treat anal pain, hemorrhoids, fissures, anal and rectovaginal fistulae, and rectal prolapse. The National Association for Continence has designated the Section of Female Pelvic Medicine and Reconstructive Surgery in Cleveland Clinic’s Ob/Gyn & Women’s Health and Digestive Disease Institutes as a Center of Excellence for Continence Care in Women.

Sacral Nerve Stimulation

Sacral nerve stimulation (SNS) is FDA-approved for the treatment of fecal incontinence, which in some patients may be impossible to control medically. This involves stimulation of the sacral nerves (S3 nerve root) and implantation of a pacemaker. Patients undergoing SNS at Cleveland Clinic are asked to complete preoperative and postoperative evaluations that assess a variety of patient-reported outcomes.

aTwo patients were ineligible to progress on to stage 2.

Stage 1 and Stage 2 Sacral Nerve Stimulation 2012 – 2013

Stage 1 (the testing phase) is designed to determine if SNS treatment will improve symptoms. The test period may be as long as 3 weeks. If symptoms decrease by at least 50% during that time, patients may be considered ineligible to progress on to stage 2 permanent device implantation.

50

40

0

N = 44 42

30

20

10

Number of Patients

Stage 1 Stage 2a


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aPGIC scores of 5–7 = significantly improved; 3–4 = somewhat improved; 0–2 = limited to no improvement.

Fecal Incontinence Severity Index Pre- and Postsacral Nerve Stimulation

The Fecal Incontinence Severity Index (FISI) measures severity of incontinence by type and frequency of leakage and is assessed before and after (6 months–1 year) sacral nerve stimulation (SNS) surgery. FISI scores range from 0–61, with higher scores indicating more severe incontinence.

2012 – 2013

Global Impression of Change After Sacral Nerve Stimulationa

The Patient’s Global Impression of Change (PGIC) is a single-item, self-reported question that assesses quality of life (QOL). Scores range from 0–7, with 0 indicating no improvement and 7 indicating significant improvement in QOL.

2012 – 2013

aTherapeutic improvement of bowel control is defined as a decrease in bowel movements by more than 50%. It is measured by patient bowel diaries and the Fecal Incontinence Severity Index.

Therapeutic Improvement of Bowel Control After Sacral Nerve Stimulationa (N = 11) 2012 – 2013

40

30

0

N = 25 15

20

10

Mean FISI Score

Pre SNS Post SNS

10

8

6

0

N = 9 2 2

4

2

Number of Patients

SignificantlyImproved

SomewhatImproved

Limited to NoImprovement

100

40

60

80

0

20

Percent of Patients

Complete continence achievedTherapeutic improvementNo improvementCondition worsened

Improvement No Improvement

Outcomes 201366

Large Bowel Disease

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Ventral Rectopexy by Procedure Type 2008 – 2013

Complications of Ventral Rectopexy 2008 – 2013

alaparoscopic bconverted from laparoscopic/robotic to open procedures

asmall bowel obstruction burinary tract infection

Ventral Rectopexy

Ventral rectopexy (VR) is a procedure to correct internal and external rectal prolapse. VR is technically challenging, and even in expert hands, is not without complications.

50

0

N = 18 11 4

40

30

20

10


Lapa

48

Robotic Open Convertedb

80

40

60

0

N = 3 4 4 6 6 8 20 66

20

Number of Complications

SBOa Ileus Respiratory Wound Urinary UTIb Other None


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Trauma Cases and Mean Length of Stay 2013

Degree of Injury Hillcrest Hospital Mean Length Northeastern Ohio Mean Length N (%) of Stay Trauma System of Stay (Days) N (%) (Days)

No injuries or noncodeable 99 (5.3%) 1.81 154 (2.61%) 2.12

Minor (ISSa 1 – 9) 1538 (81.7%) 2.07 4055 (68.7%) 2.54

Moderate (ISS 10 – 15) 129 (6.9%) 4.78 819 (13.9%) 4.82

Severe (ISS 16 – 24) 77 (4.1%) 6.08 531 (9.0%) 6.23

Critical (ISS ≥ 25) 40 (2.1%) 6.98 344 (5.8%) 7.34

Total/mean 1883 (100%) 2.51 5903 (100%) 4.61aInjury Severity Score

The Acute Care Surgery (ACS) Program provides coverage for acute general surgery and trauma at Cleveland Clinic main campus and at Hillcrest Hospital.

The trauma service is a member of the Northeastern Ohio Trauma System. Created in 2010, NOTS is a partnership between Cleveland Clinic health system and MetroHealth Medical Center, which provides integrated trauma care to the citizens of northeast Ohio. Since its inception, the collaboration has proven successful in controlling length-of-stay and mortality rates.

68 Outcomes 2013

Trauma and Acute General Surgery

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APR-DRG Severity of Illness at Admissiona October 2011 – September 2013

Observed and Expected In-Hospital Mortalitya October 2010 – September 2013

aAPR-DRG severity of illness at admission is defined as the extent of physiologic decompensation or loss of organ system function.

Source: The 3M™ All Patient Refined Diagnosis Related Groups (APR DRG) Classification System is used for adjusting data for severity of illness and risk of mortality. solutions.3m.com/wps/portal/3M/en_US/Health-Information-Systems/HIS/Products-and-Services/Products-List-A-Z/APR-DRG-Software

aExpected mortality was determined using UHC risk-adjustment methodology.

Source: These data are prepared using the University HealthSystem Consortium (UHC) Clinical Database. uhc.edu

In 2013, the ACS team was involved in the care of more than 1200 patients. Most presented with moderate to major severity of illness.

Despite severity of illness, patients’ actual mortality rate was substantially less than the expected rate based on presenting condition.

50

40

0

N = 877 1055 1295

30

20

10

Percent

2011 2012 2013

MinorModerateMajorExtreme

12

810

0

N = 877 1055 1295

6

42

Percent

2011 2012 2013

ObservedExpected

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Endoscopic Retrograde Cholangiopancreatography: Adult and Pediatric Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure used to diagnose and treat disorders of the bile and pancreatic ducts.

2011 – 2013

ERCP: Pediatric 2011 – 2013

Post-ERCP Acute Pancreatitis: Adult and Pediatric 2011 – 2013

1500

1000

0

N = 1141 1214 1357

500


2011 2012 2013

15

10

0

N = 12 14 5

5


2011 2012 2013

1.0

0.8

0.6

0.4

0.2

0

N = 1141 1214 1357

Percent

2011 2012 2013

Outcomes 201370

Pancreaticobiliary Disease

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Pancreatic Stent Placement Placement of a prophylactic pancreatic duct stent in high-risk patients has been shown to reduce the risk for post- ERCP pancreatitis. The graph shows the percentage of ERCPs where a stent was placed.

2011 – 2013

Cholangioscopy Cholangioscopy is a minimally invasive endoscopic method used for both direct visual diagnostic evaluation and simultaneous therapeutic intervention of the bile ducts. It is performed at the time of ERCP.

2011 – 2013

Endoscopic Ultrasound Endoscopic ultrasound (EUS) is increasingly used to visualize details of abdominal and esophageal structures including lymph nodes, layers of the GI tract, and vessels. EUS can be used to facilitate biopsies of areas that are inaccessible percutaneously.

2011 – 2013

15

10

5

0

N = 1141 1214 1357

Percent

2011 2012 2013

50

30

40

20

10

0

N = 47 46 50


2011 2012 2013

1500

1000

500

0

N = 1250 1356 1492


2011 2012 2013


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Cholecystectomy Cholecystectomy is one of the most common general surgical procedures for the treatment of symptomatic gallstones and other gallbladder conditions. The majority of these operations are performed laparoscopically.

2011 – 2013

Acute Cholecystitis Therapeutic Procedures Most patients with acute cholecystitis respond to conservative treatment and return for elective cholecystectomy at a later date. For the patients who do not respond to conservative treatment, the therapeutic options are urgent cholecystectomy, open or laparoscopic, or percutaneous aspiration of the gallbladder.

2011 – 2013

Management of Gallbladder Disease

2000

1500

1000

0

N = 23 21 321360 1711 1929

500


2011 2012 2013

OpenLaparoscopic

100

80

60

0

N = 11 28 65 9 27 76 14 22 91

40

20


2011 2012 2013

Percutaneous aspirationOpen cholecystectomyLaparoscopic cholecystectomy

Outcomes 201372


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30-Day Readmission Rate: Open and Laparoscopic Cholecystectomy for Acute Cholecystitis 2011 – 2013

30-Day Mortality Rate: Open and Laparoscopic Cholecystectomy for Acute Cholecystitis 2011 – 2013

2011 (N) 2012 (N) 2013 (N)

Open (%/N) 0% (0/28) 3.7% (1/27) 4.5% (1/22)

Laparoscopic (%/N) 0% (0/65) 2.6% (2/76) 2.2% (2/91)

Median Length of Stay: Open and Laparoscopic Cholecystectomy for Acute Cholecystitis 2011 – 2013

10

8

6

0

N = 28 27 2265 76 91

4

2

Days

2011 2012 2013

OpenLaparoscopic

25

20

15

0

N = 28 27 2265 76 91

10

5

Percent

2011 2012 2013

OpenLaparoscopic


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Management of Pancreatic Disease

Cleveland Clinic’s Pancreas Disorder Clinic cares for patients with a spectrum of disease, both benign and malignant, and offers multidisciplinary care teams for pancreatic cancer and chronic pancreatitis.

Pancreatectomy Procedures Several types of pancreatectomies are performed including pancreaticoduodenectomy (Whipple procedure), distal pancreatectomy, segmental pancreatectomy, and total pancreatectomy.

2011 – 2013

100

80

60

40

20

0

N = 178 215 205


2011 2012 2013

Open WhippleLaparoscopic distalpancreatectomyOpen distalpancreatectomyLaparoscopic/robotic WhippleTotalpancreatectomy

Outcomes 201374


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Median Length of Stay: Pancreatectomy Procedures 2011 – 2013

30-Day Readmission Rate: Pancreatectomy Procedures 2011 – 2013

5

4

3

2

1

0

N = 178 215 205

Percent

2011 2012 2013

12

9

6

3

0

N = 178 215 205

Days

2011 2012 2013

Open WhippleLaparoscopic distalpancreatectomyOpen distalpancreatectomyLaparoscopic/robotic WhippleTotalpancreatectomy


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Liver Biopsies

Liver biopsy is an important tool in the diagnosis and management of liver diseases.

2011 – 2013

Severe Adverse Events Following Outpatient Liver Biopsy (N = 2984)

The overall frequency of severe adverse events (SAEs) during 2011–2013 outpatient liver biopsies was 0.8% (24 of 2984). This complication rate compares very favorably with the reported frequency of these events in the medical literature.1

2011 – 2013

Type of SAE Number of SAEs SAE Rate

Bleedinga 9 0.3%

Severe pain 12 0.4%

Hypotension 2 0.07%

Pneumothorax 1 0.03%

Total SAEs 24 0.8%

aIncludes hemoperitoneum (4), subcapsular hematoma (2), hemobilia (3)

1Rockey DC, Caldwell SH, Goodman ZD, Nelson RC, Smith AD; American Association for the Study of Liver Diseases. Liver biopsy. Hepatology. 2009 Mar;49(3):1017-1044.

2011 2012 2013

2000

1500

1000

500

0

Number of Biopsies

OutpatientInpatient

N = 1655 1827 1830

Outcomes 201376

Liver Disease and Liver Transplant

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Paracentesis

Paracentesis is a diagnostic and therapeutic procedure. Large volume paracentesis is the first-line treatment for cirrhotic patients with tense and/or refractory ascites.

2011 – 2013

Paracentesis Patients Treated With Albumin

Paracentesis patients receive intravenous albumin after large volume paracentesis (> 5 L) (8 g albumin/L of ascites removed).

2011 – 2013

1500

1000

500

0

Number of Patients

2011 2012 2013

N = 1340 1325 1233

Number of Patients

800

600

400

200

02011 2012 2013

N = 691 750 723

From 2011–2013, more than half of patients (55.5%) who underwent paracentesis received intravenous albumin therapy.


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Spontaneous Bacterial Peritonitis

Patients with community-acquired spontaneous bacterial peritonitis (SBP) have outpatient paracentesis with an ascitic fluid neutrophil count > 250 cells/mm3. The prevalence of SBP in outpatients with ascites evaluated at Cleveland Clinic between 2011 and 2013 was 1.3%. This compares with previous reports of SBP in outpatients with ascites of 1.5% to 3.5%.1

2011 – 2013

aTotal number of patients with community-acquired SBP

1Evans LT, Kim WR, Poterucha JJ, Kamath PS. Spontaneous bacterial peritonitis in asymptomatic outpatients with cirrhotic ascites. Hepatology. 2003 Apr;37(4):897-901.

Percent

3

2

1

02011 2012 2013

Na = 12 15 23

Coronal multiplanar reconstruction of CT of the abdomen with contrast that demonstrates contrast opacification of existing left portal vein to middle hepatic vein shunt corresponding to patent transjugular intrahepatic portosystemic shunt (TIPS). The stent extends inferiorly in the main portal vein.

Portogram: Direct portogram obtained through transjugular approach that demonstrates contrast opacification of the main portal vein and patent TIPS.

Outcomes 201378


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TIPS Procedures 2011 – 2013

Admissions or Readmissions Within 30 Days of TIPS 2011 – 2013

Indications for TIPS 2011 – 2013

Transjugular Intrahepatic Portosystemic Shunt

Transjugular intrahepatic portosystemic shunt (TIPS) is used to treat portal hypertension-related complications, such as bleeding esophageal varices, refractory ascites, and hepatic hydrothorax. Cleveland Clinic is among the top institutions in the nation in the number of TIPS procedures it performs. A multidisciplinary approach, which includes hepatologists and radiologists, is employed in the selection of candidates best suited for TIPS procedures.

Number of Patients

140120100806040200

2011 2012 2013

N = 94 82 127

60

40

20

0

N = 1 37 55 4 33 47 11 47 59

Number of Patients

2011 2012 2013

Hepatic hydrothoraxAscitesVariceal bleeding

Percent

40

30

20

10

02011 2012 2013

Na = 94 82 127

aTotal number of patients with community-acquired SBP


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Total Outpatient Visits 2011 – 2013

Patients Transferred From Outside Institutions 2011 – 2013

Total Inpatient Visits 2011 – 2013

Inpatient Consults 2011 – 2013

Hepatology Service

Cleveland Clinic has a very active inpatient and outpatient hepatology practice. Both inpatient and outpatient practices have continued to grow in recent years.

Number of Patients

9600

7200

4800

2400

02011 2012 2013

N = 6105 7589 8772

Number of Patients

2000

1500

1000

500

02011 2012 2013

N = 1623 1631 1865

Percent

20

15

10

5

02011 2012 2013

N = 1623 1631 1865

Number of Patients

140012001000800600400200

02011 2012 2013

N = 892 1148 1240

80 Outcomes 2013


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Patients Treated for Nonalcoholic Fatty Liver Disease 2011 – 2013

Nonalcoholic Fatty Liver Disease

The Fatty Liver Disease Clinic offers a specialized and multidisciplinary approach to care for patients with this common metabolic liver disease.

Number of Patients

600

400

200

02011 2012 2013

N = 482 320 484 383 507 435

EstablishedNew

To the left is an illustration of a fatty liver that appears large and yellow in color with swollen, round edges.


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Treatment Options

The clinic has provided patients the opportunity to participate in multicentered clinical trials as part of the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network funded by the NIH.

Pioglitazone or Vitamin E for NASH — Clinical Study

Vitamin E 400 IU orally twice daily was associated with a significantly higher rate of improvement in NASH compared with placebo. There was no difference in progression of fibrosis among the study groups.1

Pentoxifylline for the Treatment of NASH — Clinical Study

Pentoxifylline 400 mg three times a day was associated with improved NASH histological scores in comparison with placebo. Although not statistically significant (P = 0.17), improvement in fibrosis was observed in a greater proportion of pentoxifylline-treated patients (35%) compared with placebo (15%).1

Outcome Vitamin E (N = 84) Placebo (N = 83) P Value

NASH improvement 43% 19% 0.005 (via biopsy)

1Sanyal AJ, Chalasani N, Kowdley KV, McCullough A, Diehl AM, Bass NM, Neuschwander-Tetri BA, Lavine JE, Tonascia J, Unalp A, Van Natta M, Clark J, Brunt EM, Kleiner DE, Hoofnagle JH, Robuck PR; NASH CRN. Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis. N Engl J Med. 2010 May 6;362(18):1675-1685.

Outcome Placebo (N = 29) Pentoxifylline (N = 26) P Value

NASH score 15% 50% < 0.001

Fibrosis score 15% 35% 0.17

1Zein CO, Yerian LM, Gogate P, Lopez R, Kirwan JP, Feldstein AE, McCullough AJ. Pentoxifylline improves nonalcoholic steatohepatitis: a randomized placebo-controlled trial. Hepatology. 2011 Nov;54(5):1610-1619.

Outcomes 201382


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Omega-3 Fatty Acids for the Treatment of NASH Patients With Diabetes — Clinical Study (N=37)

Polyunsaturated fatty acids (PUFA) provided no benefit over placebo in NASH patients with diabetes. The effects of PUFA on histology and insulin resistance were worse than placebo. These data provide no support for PUFA supplements in NASH.1

2009 – 2012

aNAS includes those patients with a diagnosis of NASH and a nonalcoholic fatty liver disease with an activity score > 4 on liver biopsy performed within 6 months of entry into the study.

1Dasarathy S, Dasarathy J, Khiyami A, Yerian L, Hawkins C, Sargent R, McCullough AJ. Double-blind randomized placebo-controlled clinical trial of omega 3 fatty acids for the treatment of diabetic patients with nonalcoholic steatohepatitis. J Clin Gastroenterol. 2014 Feb 27. [Epub ahead of print]

Unit Change

0.5

0

-0.5

-1.0

-1.5

-2.0

-2.5

-3.0Steatosis Inflammation Ballooning Fibrosis NASa

PUFAPlacebo


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Pediatric Fatty Liver Disease Clinic

The Be Well Kids’ Clinic provides multidisciplinary care for pediatric patients with a body mass index (BMI) > 85th percentile. In 2013, 201 children were evaluated, of which 35% had fatty liver disease based on alanine transaminase elevation or increased echogenicity on liver ultrasound. Researchers are trying to identify biomarkers to noninvasively diagnose nonalcoholic fatty liver disease (NAFLD). A recent study investigated the association of breath volatile organic compounds with the diagnosis of NAFLD in children.

Mean Volatile Organic Compound Levels (Adjusted for Race, Metabolic Syndrome, and ALTa)

Factor No Fatty Liver (N = 23) Fatty Liver (N = 37) P Value

Acetaldehyde 26.0 (21.4, 31.6) 35.1 (29.4, 41.8) 0.034

Acetone 36.9 (26.3, 51.9) 71.7 (52.8, 97.6) 0.008

Isoprene 8.9 (6.6, 12.0) 14.7 (11.2, 19.2) 0.022

Pentane 8.8 (7.4, 10.6) 13.3 (11.3, 15.6) 0.002

Trimethylamine 3.2 (2.6, 3.9) 5.0 (4.2, 6.0) 0.003

Breath Volatile Organic Compounds as a Noninvasive Tool to Diagnose NAFLD in Children — Clinical Study

This study showed that different concentrations of chemicals were found in the breath of obese children with fatty liver disease compared with those without the condition.1

aalanine aminotransferase

1Alkhouri N, Cikach F, Eng K, Moses J, Patel N, Yan C, Hanouneh I, Grove D, Lopez R, Dweik R. Analysis of breath volatile organic compounds as a noninvasive tool to diagnose nonalcoholic fatty liver disease in children. Eur J Gastroenterol Hepatol. 2014 Jan;26(1):82-87.

Outcomes 201384


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Hepatitis C

There are 30,000 new cases of hepatitis C virus (HCV) in the US each year. It is the leading reason for liver transplantation.

HCV Patients Treated With Antiviral Medications

In 2013 there was a significant reduction in the number of patients treated with antiviral medications. This reflects a practice change to reserve treatment while waiting for approval of more novel and effective therapies that were expected in December 2013.

2010 – 2013

HCV-treated patients (N = 282) had a liver biopsy or had clinical or radiologic evidence of cirrhosis prior to treatment. Approximately 42% of treated patients had cirrhosis. As expected, the sustained virologic response was better in patients without cirrhosis (54%) than in patients with cirrhosis (34%).

Sustained Virologic Response in Patients With and Without Cirrhosis 2011 – 2013

Number of Patients

180160140120100806040200

2010 2011 2013

N = 91 108 69

2012

164

Percent

60

40

20

10

0No Cirrhosis Cirrhosis

N = 165 117


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Sustained Virologic Response by Genotype for Nontransplant Patients

The success of hepatitis C treatment is defined as an undetectable HCV viral load 6 months after completing a course of treatment, a sustained virologic response.

2011 – 2013

Sustained Virologic Response by Genotype for Transplant Patients 2011 – 2013

Patients were treated with either combination therapy (peginterferon and ribavirin) or triple therapy (peginterferon, ribavirin, and protease inhibitors).

Percent

80

60

40

20

0All Genotypes Genotype 1 Genotype 2, 3, 4

N = 360 270 90

Percent

100

75

50

25

0All Genotypes Genotype 1 Genotype 2, 3, 4

N = 38 32 6

Outcomes 201386


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Sustained Virologic Response by Genotype 1 for Nontransplant Patients Treated With Triple Therapy 2010 – 2013

Sustained Virologic Response by Genotype 1 for Transplanted Patients Treated With Triple Therapy

In May 2011, the US Food and Drug Administration approved boceprevir and telaprevir (protease inhibitors) as add-on treatments to standard therapy with interferon and ribavirin for adult patients with genotype 1. Because of drug interactions with antirejection medications, universal use of protease inhibitors is not recommended in liver transplant recipients. Due to the complexity of the regimen and the need for close monitoring, a treatment protocol was developed at Cleveland Clinic to treat selected patients with clinically significant HCV recurrence after liver transplantation.

2011 – 2013

Approximately 47% of nontransplant genotype 1 HCV patients (N = 270) treated with triple therapy (peginterferon, ribavirin, and protease inhibitors) achieved sustained virologic response.

Fifty percent of transplanted genotype 1 HCV patients treated with triple therapy (peginterferon, ribavirin, and protease inhibitors) achieved sustained virologic response.

Percent

Triple Therapy

4846444240383634

No Yes

N = 75 195

Percent

Triple Therapy

60

40

20

0No Yes

N = 20 12


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Rifaximin Therapy and Liver Disease Complications

Cleveland Clinic researchers conducted an observational study that reviewed the medical records of 404 adult patients (2003–2007) with cirrhosis and ascites justifying paracentesis. The study found that there was a 72% reduction in the rate of spontaneous bacterial peritonitis (SBP) among cirrhotic patients with ascites who were treated with rifaximin.1 Rifaximin intestinal decontamination may also have a role in preventing other serious liver disease complications.

Role of Rifaximin in the Primary Prophylaxis of Spontaneous Bacterial Peritonitis in Patients With Liver Cirrhosis

1Hanouneh MA, Hanouneh IA, Hashash JG, Law R, Esfeh JM, Lopez R, Hazratjee N, Smith T, Zein NN. The role of rifaximin in the primary prophylaxis of spontaneous bacterial peritonitis in patients with liver cirrhosis. J Clin Gastroenterol. 2012 Sep;46(8):709-715.

00

100100

4040

6060

8080

2020

SBP-Free (%)SBP-Free (%)

120

90% ± 6%(19)

64% ± 3%(83)

3624Months After Paracentesis

48 60

76% ± 11%(7)

48% ± 5%(29)

76% ± 11%(9)

55% ± 4%(49)

76% ± 11%(1)

47% ± 5%(11)

NA

37% ± 7%(6)

RifaximinNo rifaximinP Value = 0.001

Rifaximin (N = 49)

No rifaximin(N = 355)

Outcomes 201388


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Celiac Disease in Patients With Cirrhosis

Although considered primarily a malabsorptive disorder affecting the small bowel mucosa, celiac disease can be associated with damage to other organ systems including the liver. The prevalence of celiac disease in the cirrhotic population is not known.

A recent prospective Cleveland Clinic study of patients with cirrhosis who received a screening upper endoscopy, human leukocyte antigen (HLA) typing, and celiac serological testing found that celiac disease was more than twice (2.5%) as common in patients with cirrhosis as in the general population. Treatment with a gluten-free diet resulted in improved liver function.1

Additionally, the current criteria for diagnosing celiac disease requires a small bowel biopsy in patients who have abnormal levels of of human tissue transglutaminase (hTTG)> 20 IU/mL. The study found that hTTG > 118 IU is highly specific (98%) and can be used to diagnose celiac disease in patients who are not willing or are unable to have an upper endoscopy and a small bowel biopsy. This finding can help clinicians determine when celiac disease is present with a specific laboratory measure that may improve the diagnosis of celiac disease without the additional delay and costs of an upper endoscopy.1

Prevalence of Celiac Disease 2008 – 2012

Higher hTTG Cutoff Improved Specificity for Diagnosis of Celiac Disease

aCleveland Clinic patients with cirrhosis from January 2008 to November 2012.

atissue transglutaminase

1Fasano A, Berti I, Gerarduzzi T, Not T, Colletti RB, Drago S, Elitsur Y, Green PH, Guandalini S, Hill ID, Pietzak M, Ventura A, Thorpe M, Kryszak D, Fornaroli F, Wasserman SS, Murray JA, Horvath K. Prevalence of celiac disease in at-risk and not-at-risk groups in the United States: a large multicenter study. Arch Intern Med. 2003 Feb 10;163(3):286-292.

Percent

3

2

1

0General

PopulationPatients With

Cirrhosisa

N = 4126 204

00

1.01.0

0.40.4

0.60.6

0.80.8

0.20.2

SensitivitySensitivity

0.20 0.60.41 – Specificity

0.8 1.0

TTGa > 20

TTG > 118


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Liver Tumor Clinic

Cleveland Clinic’s Liver Tumor Clinic uses a multidisciplinary approach to treat liver tumors, both benign and malignant. Treatment options include surgical resection (open, laparoscopic, and robotic) and nonsurgical treatment (chemoembolization, TheraSphere®, radiofrequency ablation). The team includes medical and radiation oncologists, interventional radiologists, hepatologists, and transplant/hepatobiliary surgeons.

Patients, New and Established 2011 – 2013

Median Number of Days From Initial Visit to Intervention 2011 – 2013

Liver Malignancies 2011 – 2013

ahepatocellular carcinoma

Days

40

30

20

10

02011 2012 2013

N = 156 207 157

140120100806040200

N = 17 85 102 25 101 109 31 90 117

Number of Malignancies

2011 2012 2013

CholangiocarcinomaHCCa

Metastatic liver tumor

2011 2012 2013

700600500400300200100

0

Number of Patients

N = 558 579 555

EstablishedNew

Outcomes 201390


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91

Benign Liver Tumors 2011 – 2013

afocal nodular hyperplasia

30

20

10

0

N = 49 63 49

Number of Benign Tumors

2011 2012 2013

CystHemangiomaAdenomaFNHa

CT scan shows a 20 cm hepatoma in the center of the liver (arrows).

CT scan is the image of the liver post liver resection.


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92

Liver Tumor Treatment Options 2011 – 2013

Liver Tumor Surgical Procedures 2011 – 2013

aradiofrequency ablation

400

300

200

100

0

N = 584 609 579

Number of Cases

2011 2012 2013

No treatmentSurgicalNonsurgical

160

120

80

40

0

N = 190 171 194


2011 2012 2013

OpenLaparoscopic resectionLaparoscopic RFAa

Robotic

Outcomes 201392


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93

Liver Resections 2011 – 2013

Liver Resection: Median Length of Stay 2011 – 2013

aData not available for all patients who underwent liver resection.

Days

76543210

2011 2012 2013

Na = 109 92 113

Liver Resection: 30-Day Readmission Rate 2011 – 2013

aData not available for all patients who underwent liver resection.

706050403020100

N = 116 99 116

Number of Resections

2011 2012 2013

Left hepatectomyRight hepatectomySegmentectomyNonanatomic liver resection

Percent211815129630

2011 2012 2013

Na = 109 92 113


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94 Outcomes 201394


Recurrence of Malignant Tumors and Survival Following Laparoscopic Liver Resection for Various Tumor Types (N = 111) 2006 – 2013

Type of Tumor

Neuroendocrine

Hepatocellular

Colorectal

Othera

Five-Year Disease-Free Survival (%)

44.4

37.6

30.5

23.3

Five-Year Overall Survival (%)

80.0

70.8

53.8

53.2

Type of Tumor

Colorectal

Hepatocellular

Neuroendocrine

Othera

N

66

24

6

15

Recurrence (%)

59.5

21.6

5.4

13.5

aBreast (N = 3), cholangiocarcinoma (N = 3), renal (N = 2), sarcoma (N = 1), gastrointestinal stromal tumor (N = 1), ovary (N = 1), melanoma (N = 1), urothelial (N = 1), paraganglioma (N = 1), primary unknown (N = 1)

aBreast, cholangiocarcinoma, sarcoma, gastrointestinal tumor, ovary, melanoma, renal, urothelial, paraganglioma, primary unknown

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95

Liver Tumor Nonsurgical Procedures 2011 – 2013

120

90

60

30

0

N = 223 213 270


2011 2012 2013

TheraSphereTranscatheter arterialchemoembolizationBland embolizationSystemic inflammatory response syndromeRadiofrequency ablation


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96

Patients Referred, Evaluated, and Listed 2011 – 2013

Liver Transplantation 2011 – 2013

Patient Removals From the Wait List 2011 – 2013

aincludes all removals for reasons other than death and transplantation bpatient deaths while on the liver transplant wait list

Liver TransplantCleveland Clinic performed its first adult liver transplant on Nov. 8, 1984, and has completed 1962 liver transplants to date, including 1874 liver transplants alone and 87 multiorgan transplants: 70 liver/kidney, five liver/heart, four liver/lung, four liver/pancreas, and four liver/intestine/pancreas.

Number of Transplants150

120

90

60

30

02011 2012 2013

N = 122 143 128

800

600

400

200

0

N = 565 440 193 768 418 217 707 455 212

Number of Patients

2011 2012 2013

ReferredEvaluatedListed

100

80

60

0

N = 73 57 3420 14 30

40

20

Number of Patients

2011 2012 2013

Removalsa

Deathsb

Outcomes 201396


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Median Time to Transplanta

2011 – 2013

Candidates wait-listed at Cleveland Clinic for a liver transplant are transplanted more than 8 months faster than the national median wait time.aTime determined by number on wait list at the start of each year

Source: Scientific Registry of Transplant Recipients (SRTR). srtr.org

aObserved rates for 2011 and 2012 were both statistically significantly higher than the expected rate (P < 0.01).


Transplant Rate for Patients Waiting for Liver Transplantation

Transplant rate is calculated in person-years (days converted to fractional years): the number of days from Jan. 1 or from the date of first wait-listing until death, transplant, 60 days after recovery, transfer, or Dec. 31. The expected transplant rate is adjusted for age, blood type, medical urgency status, time on the wait list, and previous transplantation.

2011 – 2012

Months

15

12

9

6

3

02011 2012 2013

N = 214 213 190

Cleveland ClinicNational medianwait time

Months

80

60

40

20

02011 2012

N = 213 190

Observeda

Expected


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98



One-Year Adult Graft Survival 2011 – 2013

One-Year Adult Patient Survival 2011 – 2013

Percent

100

90

802011 2012

N = 291 277

2013

293

ObservedExpectedNational average



Three-Year Adult Patient Survival 2011 – 2013

Three-Year Adult Graft Survival 2011 – 2013

Percent

85

80

75

702011 2012

N = 316 327

2013

319


Patient Survival

Observed survival greater than the national average and greater than expected was seen in 2013.

Graft Survival

Percent

85

80

75

702011 2012

N = 292 304

2013

302


Percent

100

90

802011 2012

N = 308 289

2013

293


Outcomes 201398


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99

Donation After Cardiac Death Transplants 2011 – 2013

adonation after cardiac death bdonation after brain death

Donor Organs Transplanted

The majority of organs utilized are standard organs donated after brain death. Other organ types used include organs donated after cardiac death, split liver grafts, and living donor grafts, which significantly expands the number of transplants performed annually.

2011 – 2013

25

20

15

10

5

0

Number of Transplants

N =

2011 2012 2013

12 16 20

150

50

100

0


N =

Living donorSplit donorDCDa

DBDb

2011 2012 2013

122 143 128


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100

aModel for End-Stage Liver Disease

1DeOliveira ML, Jassem W, Valente R, Khorsandi SE, Santori G, Prachalias A, Srinivasan P, Rela M, Heaton N. Biliary complications after liver transplantation using grafts from donors after cardiac death: results from a matched control study in a single large volume center. Ann Surg. 2011 Nov;254(5):716-722.

Donation After Cardiac Death Patient Population and Biliary Stricture Rate (N = 81)

The most significant problem with the use of DCD donors is increased rates of primary nonfunction and ischemic type biliary strictures. Due to better understanding of the recovery process, shorter cold ischemia time and greater use of tissue plasminogen activator, our biliary stricture rate (1.35% primary nonfunction and 3.7% ischemic type) is significantly less than the 9% to 33%1 stricture rate that is reported in the literature.

2009 – 2013

Age (Years) MELDa Score Donor Age Cold Ischemia Warm Ischemia Primary Ischemic Type Time (Minutes) Time (Minutes) Nonfunction Biliary Stricture Biliary Stricture Rate Rate

57 ± 9 22 ± 6 39 ± 13 386 ± 77 23 ± 6 1.35% (1/74) 3.7% (3/81)

Outcomes 2013100


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Living Donor Transplants 2011 – 2013

Combined Liver/Kidney Transplants 2011 – 2013

Split Liver Transplants 2011 – 2013


10

8

6

4

2

02011 2012 2013

N = 4 8 7

2011 2012 2013

14121086420


N = 0

0

12 10

Right lobeLeft lobe

2011 2012 2013

18

12

6

0


N = 11 16 6

Right lobeLeft lobe


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102

aScientific Registry of Transplant Recipients (SRTS) National Average for 1-Year Patient Survival = 90.18%. srtr.org bdonation after brain death cdonation after cardiac death

aScientific Registry of Transplant Recipients (SRTS) National Average for 3-Year Patient Survival = 80.08%. srtr.org bdonation after brain death cdonation after cardiac death

One-Year Patient Survival: Adult Primary Liver Transplant Onlya 2011 – 2013

Three-Year Patient Survival: Adult Primary Liver Transplant Onlya 2011 – 2013

00

100100

4040

6060

8080

2020

Survival (%)Survival (%)

600

Days After Transplantation120 180 240 300 360

DBDb (N = 253)DCDc (N = 47)Living donor (N = 20)Split (N = 24)

00

100100

4040

6060

8080

2020


0Days After Transplantation

200 400 600 800 1000


Patient Survival

Outcomes 2013102


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103

aScientific Registry of Transplant Recipients (SRTS) National Average for 3-Year Graft Survival = 76.48%. srtr.org bdonation after brain death cdonation after cardiac death

aScientific Registry of Transplant Recipients (SRTS) National Average for 1-Year Graft Survival = 87.62%. srtr.org bdonation after brain death cdonation after cardiac death

Three-Year Graft Survival: Adult Primary Liver Transplant Onlya 2011 – 2013

One-Year Graft Survival: Adult Primary Liver Transplant Onlya 2011 – 2013

00

100100

4040

6060

8080

2020



120 180 240 300 360


00

100100

4040

6060

8080

2020



200 400 600 800 1000


Graft Survival


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104

Liver Transplant Mean Length of Stay

Cleveland Clinic’s liver transplant team started a project to streamline the postoperative clinical care pathways in 2010 that resulted in an immediate reduction in length of stay (LOS) from 16.9 days in 2009 to 12 days in 2010. The reduction in LOS was sustained in 2011 and 2012, and the Model for End-Stage Liver Disease (MELD) score remained stable, ranging from 18–20. In 2013 the mean MELD score increased from 19 to 26, and the mean LOS increased to 14.5 days. In 2013, 10 patients had LOS > 30 days.

2009 – 2013

30-Day Liver Transplant Readmission Rate

Monthly monitoring and review of readmissions has resulted in a reduction in the rate of readmissions from 50% in 2010 to 30% in 2013.

2011 – 2013

aData not available for all liver transplant patients.

aData not available for all liver transplant patients.

Percent

60

40

20

02011 2012 2013

Na = 113 111 112

18

12

6

0

30

20

10

0

Na = 135 128 119

2009 2010 2011

134

2012

124

2013

DaysDays MELD Score

Outcomes 2013104


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105

Management of Postoperative Pain

HCAHPS Survey for Liver Transplant Pain Management

Pain management is difficult in the transplant population. A multidisciplinary team of surgeons, physician assistants, nurses, and a transplant pharmacist developed a pain protocol for liver transplant patients in 2011. Based on Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) surveys, there was an overall improvement in pain scores from 2011 to 2013.

2011 – 2013

aResponse options: Always, Usually, Sometimes, Never bDuring this hospital stay, how often was your pain well controlled? cDuring this hospital stay, how often did the hospital staff do everything they could to control your pain? dPercentage of patients responding “Always” to both questions is averaged together

80

60

40

20

0

Percent Best Response (Always)a

2011 2012 2013

Pain controlb

Pain managementc Pain management domaind

Benchmark

N= 27 35 24


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106

Adjuvant Therapies Prior to Transplantationa

Patients are treated prior to transplant with the goal of downstaging or controlling cancer growth. Criteria for adjuvant treatment prior to transplant includes a single tumor ≥ 3 cm; two lesions < 2.5 cm each; two lesions either one > 2.5 cm; or α-fetoprotein > 100 ng/ml.

2011 – 2013

Liver Transplant for Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the fifth most common cancer in men and the seventh most common cancer in women. Liver transplantation is the standard of care for patients with HCC complicated by cirrhosis and portal hypertension. In order to be acceptable candidates for liver transplantation, patients must have HCC lesions within the Milan criteria. Locoregional therapy has been used to downstage HCC in selected patients who fall outside the Milan criteria in order to proceed to liver transplantation.

Liver Transplants for All Patients With Hepatocellular Carcinoma 2011 – 2013

Patients With Hepatocellular Carcinoma Within and Beyond Milan Criteria 2011 – 2013

aIn 2012, there was one resection. bTransarterial chemoembolization cCombined therapies can include any combination of radiofrequency ablation (RFA), Y-90, or embolization.

60

40

0

N = 39 46 49

20


2011 2012 2013 2011 2012 2013

60

40

20

0

Number of Patients

N = 39 46 49

Beyond MilanWithin Milan

25

20

15

10

5

0

N = 32 28 32

Number of Therapies

2011 2012 2013

Embolization: TACEb/blandCombined therapiesc

RFAY-90

Outcomes 2013106


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107

Three-Year Patient Survival: Within and Beyond Milan Criteria 2009 – 2013

Recurrence Outcomes, Within and Beyond Milan Criteria 2011 – 2013

Three-Year Graft Survival: Within and Beyond Milan Criteria 2009 – 2013

aNot applicable

2011 2012 2013

Recurrence rate (%)

Within Milan criteria (N) 0% (0/23) 11% (3/28) 0% (0/32) Beyond Milan criteria (N) 33% (3/9) 29% (2/7) 11% (1/9)

Time to recurrence (days) (mean ± SD)

Within Milan criteria N/Aa 353 ± 132 N/A Beyond Milan criteria 310 ± 28 683 ± N/A 116 ± N/A

00

100100

4040

6060

8080

2020



200 400 600 800 1000

Within Milan (N = 104)Beyond Milan (N = 31)

00

100100

4040

6060

8080

2020



200 400 600 800 1000

Within Milan (N = 104)Beyond Milan (N = 31)


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108 Outcomes 2013108

Obesity

Bariatric Surgery

In 2013, Cleveland Clinic’s Bariatric and Metabolic Center marked its eighth anniversary and continued to be accredited as a designated Bariatric Surgery Center of Excellence by the American Society for Metabolic and Bariatric Surgery and the American College of Surgeons. This designation is awarded to programs that meet high quality standards and perform a minimum of 125 procedures annually.

Bariatric Surgery Cases by Type

2007 – 2013In 2013, laparoscopic Roux-en-Y gastric bypass, with 419 cases (56%), was the most frequently performed bariatric procedure at Cleveland Clinic. Laparoscopic sleeve gastrectomy continued to grow and was the second most commonly performed procedure, with 230 cases (31%). Due to patient preference, laparoscopic adjustable gastric banding has shown large declines over the past several years. Forty-three cases were performed at Fairview Hospital, a Cleveland Clinic hospital.

aOther includes other bariatric procedures such as gastric plication +/- band, duodenal switch, distal bypass, and band removal.

Gastric Plication Sleeve Duodenal SwitchBandBypass Banded Plication

IN 2013, 57 BARIATRIC CASES WERE PERFORMED ROBOTICALLY

Cases

0

800

600

400

200

2007 2008 2009 2010 2011

Othera

RevisionBandingSleeveBypass

2012 2013

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Comorbidities at Baseline Among Patients Undergoing Laparoscopic Roux-en-Y Gastric Bypass

2011 – 2013

Comorbidities at Baseline Among Patients Undergoing Laparoscopic Sleeve Gastrectomy

2011 – 2013

*MBSC = Michigan Bariatric Surgery Collaborative

Source: Carlin AM, Zeni TM, English WJ, Hawasli AA, Genaw JA, Krause KR, Schram JL, Kole KL, Finks JF, Birkmeyer JD, Share D, Birkmeyer NJ; Michigan Bariatric Surgery Collaborative. The comparative effectiveness of sleeve gastrectomy, gastric bypass, and adjustable gastric banding procedures for the treatment of morbid obesity. Ann Surg. 2013;257(5):791-797.

Percent

0

80

60

40

20

Cleveland Clinic (N = 1156)MBSC* (N = 2949)

Hypertension SmokingDiabetesMellitus

ObstructiveSleepApnea

Hyper-lipidemia

VenousThrombo-embolism

RenalFailure

0.21.0

Percent

0

80

60

40

20

Cleveland Clinic (N = 353)MBSC* (N = 2949)

Hypertension SmokingDiabetesMellitus

ObstructiveSleepApnea

Hyper-lipidemia

VenousThrombo-embolism

RenalFailure

0.30.6

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Obesity

*These data are prepared using the University HealthSystem Consortium (UHC) Clinical Database. uhc.edu

aCleveland Clinic data are non-risk-adjusted.

*MBSC = Michigan Bariatric Surgery Collaborative

Source: Carlin AM, Zeni TM, English WJ, Hawasli AA, Genaw JA, Krause KR, Schram JL, Kole KL, Finks JF, Birkmeyer JD, Share D, Birkmeyer NJ; Michigan Bariatric Surgery Collaborative. The comparative effectiveness of sleeve gastrectomy, gastric bypass, and adjustable gastric banding procedures for the treatment of morbid obesity. Ann Surg. 2013;257(5):791-797.

Laparoscopic Sleeve Gastrectomy Length of Stay

2011 – 2013

30-Day Complication Rates for All Bariatric Cases

2011 – 2013

Laparoscopic Roux-en-Y Length of Stay

2011 – 2013

5

4

0

3

2

1

Days

N = 95 129 198N = 227 303 383

2011 2012 2013

Cleveland ClinicUHC US NEWS Top 10*

5

4

0

3

2

1

Days

N = 431 430 342N = 385 347 312

2011 2012 2013


5

4

0

3

2

1

Percent

Bleeding Wound Infection/Evisceration

IntestinalObstruction

AnastomoticLeak

Deep VeinThrombosis

RespiratoryFailure

Cleveland Clinica (N = 1908)MBSC* (N = 2949)

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Type

All bariatric surgeries % (N)

Laparoscopic Roux-en-Y gastric bypass % (N)

Laparoscopic sleeve gastrectomy % (N)

0.3 (1908)

0.4 (1258)

0.0 (434)

BOLD*

0.1 (186,576)†

0.14 (136,036)

0.08 (15,964)

Cleveland Clinic 2011 – 2013

*These data are prepared using the University HealthSystem Consortium (UHC) Clinical Database. uhc.edu

*BOLD = Bariatric Outcomes Longitudinal Database, a database of the American Society for Metabolic & Bariatric Surgery

Source: National Comparisons of Bariatric Surgery Safety and Efficacy: Findings from the BOLD Database 2007–2010. Paper presented at: 29th Annual Meeting of the American Society for Metabolic & Bariatric Surgery; June 17–22, 2012; San Diego, CA. Abstract PL-104.

†Source: Inabet WB 3rd, Winegar DA, Sherif B, Sarr MG. Early outcomes of bariatric surgery in patients with metabolic syndrome: an analysis of the bariatric outcomes longitudinal database. J Am Coll Surg. 2012;214(4):550-556.

Percent of Patients Requiring Intensive Care Unit Admission: Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Sleeve Gastrectomy

2011 – 2013

30-Day Mortality Rates for Bariatric Surgery

2011 – 2013

8

6

0

4

2

Percent

N = 526 559 540N = 612 650 695

2011 2012 2013


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Obesity

100

80

0

60

40

20

Percent

127 110 140 185N =Sleep Apnea Diabetes Hyperlipidemia Hypertension

100

80

0

60

40

20

Percent

1156 173 113 77692 336N =Laparoscopic Roux-en-Y Laparoscopic Banding

1 Year2 Years3 Years

Mean Percent Weight Lossa Toward Ideal Body Mass Index at Follow-Up

2008 – 2013

Comorbidity Resolution at 3-Year Follow-Up for All Bariatric Surgery Cases

2011 – 2013

aWeight loss formula: (baseline BMI – follow-up BMI) / (baseline BMI – ideal BMI [25]) x 100

For cases followed up at 3 years, laparoscopic Roux-en-Y gastric bypass had the highest percentage of weight loss toward ideal body mass index, at 66%.

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Bariatric Behavioral Health

Bariatric Surgery Clearance After Multidisciplinary Review of High-Risk Psychiatric Patients (N = 136)

2009 – 2010

A bimonthly multidisciplinary committee composed of medical, surgical, nutritional, and psychological professionals meets to discuss high-risk patients seeking bariatric surgery. Both the medical and the psychiatric risks of bariatric surgery must be balanced with the medical and psychiatric risks of uncontrolled severe obesity and its complications. A retrospective chart review was completed on all patients discussed over a 2-year period from 2009–2010 to assess patient surgery status. Patients cleared for and having bariatric surgery showed weight loss and comorbidity outcomes consistent with overall program outcomes.

Eligible for Surgerybut Did Not Achieve

Behavioral Requirements

Not Cleared for Surgery

Cleared for Surgery

100

80

0

60

40

20

Percent

84 35 17N =

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114

Somatic complaints (e.g., excessive pain and nausea)

Internalizing emotional disorders (e.g., anxiety, demoralization)

External behavioral dysfunction (e.g., impulsivity and disinhibition)

Postoperative Survey of Patient Complaints and Behaviors

Pre

oper

ativ

e P

sych

olog

ical

Tes

tinga

Somatic Problems

0.30 (P < 0.005)

Psychological Distress (e.g., grieving the loss of food)

0.43 (P < 0.001)

Maladaptive Eating (e.g., graze eating)

0.30 (P < 0.005)

0.36 (P < 0.005)

Predictors From Preoperative Psychological Testing (N = 329)

2010 – 2013

aMinnesota Multiphasic Personality Inventory-2-Restructured Form

R2 correlations are between MMPI-2-RF® scale scores and postoperative concerns.

Source: Marek RJ, Ben-Porath YS, Merrell J, Ashton K, Heinberg LJ. Predicting one and three month postoperative Somatic Concerns, Psychological Distress, and Maladaptive Eating Behaviors in bariatric surgery candidates with the Minnesota Multiphasic Personality Inventory-2 Restructured Form (MMPI-2-RF). Obes Surg. 2014;24(4):631-639.

Preoperative psychological testing predicts some somatic complaints, psychological distress, and maladaptive eating behaviors at 3 months after bariatric surgery. Psychological evaluation of bariatric surgery candidates often includes standardized psychological testing. Preoperative scores on the Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF) were examined in the context of self-reported difficulties and behaviors at 3 months postsurgery.

Outcomes 2013114

Obesity

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115

100

80

0

60

40

20

Percent

DrinkBefore Thirsty

Take 20 – 30Min/Meal

Daily PhysicalActivity Routine

Drink48 oz/Day

Exercise5x/Week

Protein60 – 80 g/Day

Eat 5 Small Meals/Day

Adherence to Bariatric Surgery Recommendations After Roux-en-Y Gastic Bypass at 4- to 6-Week Follow-Up (N = 37)

2013

Preoperative screening may help identify and predict which patients will have a more challenging postoperative course. Recent research has demonstrated that clinically significant cognitive impairment is present in up to 23% of bariatric surgery patients and that these baseline preoperative impairments predict weight loss outcomes at 1 year. Such impairments could also contribute to poorer adherence. Cognitive testing and a self-report measure of adherence to postoperative bariatric guidelines were completed during a 4- to 6-week postoperative appointment for patients who had undergone laparoscopic Roux-en-Y gastric bypass surgery. Early nonadherence to recommendations for eating small regular meals and exercising five times weekly were noted in these patients.

Source: Spitznagel MB, Galioto R, Limbach K, Gunstad J, Heinberg LJ. Cognitive function is linked to adherence to bariatric postoperative guidelines. Surg Obes Rel Dis. 2013;9(4):580-585.


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116

Nonsurgical Weight Management

Appointment Compliance With Weight Management Programs (N = 1224)

Sep 2012 – Dec 2013

Appointment Status Based on Type of Scheduled Weight Management Program (N = 1224)

Sep 2012 – Dec 2013

100

80

0

60

40

20

Percent

N = 229 995 Weight Management Program Protein-Sparing Modified Fast

Completed One or More AppointmentsNo Show/Canceled Appointments

100

80

0

60

40

20

Percent

N = 229 995 Weight Management Program Protein-Sparing Modified Fast

No ShowCanceledCompleted

During 16 months, there were 2944 appointments scheduled for 995 patients for the Weight Management Program (WMP) and 681 appointments for 229 patients for the Protein-Sparing Modified Fast (PSMF) program. The WMP is offered by registered dietitians and utilizes various lifestyle and nutrition strategies to assist patients with weight loss.

Participants in both the WMP and the PSMF program are expected to attend regular and frequent appointments, which many are unable to do. Forty-four percent of PSMF program patients and 57% of WMP patients canceled or did not show up for appointments.

Outcomes 2013116

Obesity

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117

Body Mass Index Change Based on Program and Number of Completed Visits

Sep 2012 – Dec 2013

Baseline and Follow-Up Body Mass Index Based on Type of Weight Management Program and Completed Visits

2013

The Protein-Sparing Modified Fast (PSMF) program is monitored by a physician or nurse practitioner in collaboration with a registered dietitian who provides patient education for both the PSMF and Weight Management Programs (WMP). Patients completing four or more visits showed greater improvement in BMI, with PSMF patients having the greatest reduction in BMI.

Visits

0.0

-1.0

-5.0

-2.0

-3.0

-4.0

BMI Change

-6.0a. ≥ 3 b. ≥ 4 c. ≥ 3 d. ≥ 4 e. ≥ 7

Program

a. WMP only b. WMP only c. PSMF w/ or w/o WMP d. PSMF w/ or w/o WMP e. PSMF w/ or w/o WMP

Program

a. WMP only b. WMP only c. PSMF w/ or w/o WMP d. PSMF w/ or w/o WMP e. PSMF w/ or w/o WMP

N

36 16 95 68 16

N

36 16 95 68 16

Visits

≥ 3 ≥ 4 ≥ 3 ≥ 4 ≥ 7

BMI (kg/m2)

Protein-Sparing Modified Fast

34

28

32

30

Weight Management Programa. b. c. d. e.

46

44

36

42

40

38

Baseline BMILast BMI


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118

Percentage of Screening Mammograms Resulting in Callback 2011 – 2013

Surgery for Breast Cancera 2011 – 2013

Cleveland Clinic offers a diagnostic callback program for patients with abnormal screening mammograms. The callback rate has been under 15% for several years. This is consistent with the National Comprehensive Cancer Network (NCCN) benchmark of 5% to 15%.

The breast conservation rate is above 56% for all breast cancer surgeries. This exceeds the NAPBC ideal benchmark of 50% for breast conservation surgery in patients with stage 0, 1, or 2 breast cancer.aIncludes all breast cancers plus prophylactic mastectomy with breast reconstruction

20

15

0

N = 60,977 63,186 65,441

10

5

Percent

2011 2012 2013

100

75

0

N = 984 1089 1323

50

25

Percent

2011 2012 2013

MastectomyLumpectomy

Outcomes 2013118

Breast Disease

Cleveland Clinic’s Breast Center offers a multidisciplinary team of highly skilled specialists who provide comprehensive care to patients with breast cancer. A full array of services ranges from initial screening and diagnosis to innovative breast cancer treatment and supportive counseling. The Breast Center at Cleveland Clinic’s main campus was recently awarded a 3-year accreditation by the American College of Surgeons’ National Accreditation Program for Breast Centers (NAPBC).

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119

Immediate Breast Reconstruction 2011 – 2013

More than 30% of breast cancer surgeries include immediate reconstruction performed by a plastic surgeon specializing in breast reconstruction.

40

30

0

N = 984 1089 1323

20

10

Percent

2011 2012 2013


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120120

Five-Year Relative Survival of Female Patients with All Stages of Breast Cancer (N = 4154)

2006 – 2012

American Joint Committee on Cancer (AJCC) stage I – IV breast cancer.

CC = Cleveland Clinic.

Ref = Fast Stats: An interactive tool for access to SEER cancer statistics. Surveillance Research Program, National Cancer Institute. seer.cancer.gov/faststats. (Accessed on 4-15-2014). 1992–2010 (SEER 13).

Cleveland Clinic’s Breast Center is committed to providing patients with the best possible prevention, detection, and treatment options for breast disease. A multidisciplinary team comprising surgeons, medical oncologists, radiation oncologists, nurses, and social workers collaborate with each patient to develop a care plan.

Cleveland Clinic main campus, Beachwood Family Health Center, and Fairview Hospital Breast Centers are accredited by the National Accreditation Program for Breast Centers (NAPBC), a program administered by the American College of Surgeons.

Breast Cancer

00

100100

4040

6060

8080

2020


0 21Years After Diagnosis

3 4 5

CCRef

Percent Survival(Number at Risk) =

100(3750)

100(2953)

99.6(2209)

99.2(1546)

98.4(970)

Outcomes 2013120

Breast Disease

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121

Five-Year Relative Survival of Patients with Breast Cancer by Stage at Diagnosis (N = 4154)

2006 – 2012



Ref = Surveillance, Epidemiology and End Results (SEER). SEER 1996-2007 (SEER 13 96-99, SEER 17 00-07). Software: Surveillance Research Program, National Cancer Institute SEER*Stat software (seer.cancer.gov/seerstat) version 7.0.9. Data: Surveillance, Epidemiology, and End Results (SEER) Program (seer.cancer.gov) SEER*Stat Database: Incidence - SEER 17 Regs Research Data + Hurricane Katrina Impacted Louisiana Cases, Nov 2010 Sub (1973-2008 varying) - Linked To County Attributes - Total U.S., 1969-2009 Counties, National Cancer Institute, DCCPS, Surveillance Research Program, Cancer Statistics Branch, released April 2011 (updated 10/28/2011), based on the November 2010 submission.

Percent Survival and (Number at Risk) by Stage

Years After Diagnosis

Stage 1 2 3 4 5

I 100 (1973) 100 (1580) 100 (1192) 100 (835) 100 (543)

II 100 (1237) 100 (969) 100 (733) 100 (510) 98.5 (314)

III 100 (414) 94.4 (318) 90.6 (231) 88.3 (167) 86.1 (95)

IV 81.4 (126) 71.6 (86) 62.9 (51) 56.0 (33) 53.8 (18)

00

100100

4040

6060

8080

2020



3 4 5

Stage I CC (N = 2174)Stage I RefStage II CC (N = 1354)Stage II RefStage III CC (N = 455) Stage III RefStage IV CC (N = 171) Stage IV Ref


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122122 Outcomes 2013122

Breast Disease

Five-Year Relative Survival of Patients with Breast Cancer by Racea (N = 4025)

2006 – 2012

aSelf-reported.



Ref = Fast Stats: An interactive tool for access to SEER cancer statistics. Surveillance Research Program, National Cancer Institute. seer.cancer.gov/faststats. (Accessed on 4-18-2014).


Years After Diagnosis

Race 1 2 3 4 5

Black 97 (524) 95.4 (412) 92.5 (295) 91.6 (189) 90.5 (106)

White 99.2 (3116) 97.8 (2454) 97.5 (1847) 97.1 (1315) 96.4 (837)

00

100100

4040

6060

8080

2020



3 4 5

Black (N = 599)Black RefWhite (N = 3426)White Ref

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123123

Five-Year Overall Survival of Patients with Early-Stage Breast Cancer Treated with Radiation (N = 624)

2006 – 2013


Years After Treatment

Stage 1 2 3 4 5

0 100 (114) 99.1 (97) 96.9 (81) 94.2 (61) 94.2 (41)

I 99.3 (254) 98.4 (210) 97.4 (174) 97.4 (131) 93.9 (86)

IIA 99.2 (114) 96.3 (88) 93.9 (71) 90.9 (51) 90.9 (36)

IIB 95.7 (63) 89.1 (50) 89.1 (38) 86.5 (29) 86.5 (21)

Patients who received radiation therapy at Cleveland Clinic main campus.


Ref = Reference group data from the National Cancer Data Base (Commission on Cancer of the American College of Surgeons and the American Cancer Society) 2001–2002, as reported in: Edge SB, Byrd DR, Compton CC, et al. AJCC Cancer Staging Manual. 7th ed. New York, NY: Springer Science & Business Media; 2010.

00

100100

4040

6060

8080

2020


0 21Years After Treatment

3 4 5

Stage 0 CC (N = 131)Stage 0 RefStage I CC (N = 288)Stage I RefStage IIA CC (N = 132) Stage IIA RefStage IIB CC (N = 73) Stage IIB Ref


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124

Five-Year Overall Survival of Patients with Late-Stage Breast Cancer Treated with Radiation (N = 174)

2006 – 2013

Patients who received radiation therapy at Cleveland Clinic main campus.


Ref = Reference group data from the National Cancer Data Base (Commission on Cancer of the American College of Surgeons and the American Cancer Society) 2001–2002, as reported in: Edge SB, Byrd DR, Compton CC, et al. AJCC Cancer Staging Manual. 7th ed. New York, NY: Springer Science & Business Media; 2010.


Years Since Treatment

Stage 1 2 3 4 5

IIIA 97.4 (71) 94.5 (59) 89.2 (46) 84.9 (35) 84.9 (27)

IIIB 85.2 (10) 67.3 (7) 67.3 (3) 67.3 (2) 67.3 (2)

IIIC 85.2 (20) 59.6 (14) 50.8 (11) 44.8 (5) 44.8 (3)

IV 59.6 (23) 56.8 (19) 41.8 (14) 32.9 (11) 32.9 (5)

00

100100

4040

6060

8080

2020


0 21Years After Treatment

3 4 5

Stage IIIA CC (N = 81)Stage IIIA RefStage IIIB CC (N = 15)Stage IIIB RefStage IIIC CC (N = 30) Stage IIIC RefStage IV CC (N = 48) Stage IV Ref

Outcomes 2013124

Breast Disease

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125

Combination Chemotherapy Considered or Administered Within 120 Days of Diagnosis for Women Under Age 70 with Hormone Receptor-Negative Breast Cancer (N = 101)

2010 – 2011

Cleveland Clinic met the Commission on Cancer care quality standard at 91% (92 of 101 patients) for 2010–2011, exceeding the 90% goal. Of the 9 patients where combination chemotherapy was not considered or administered, 8 patients received combination chemotherapy beyond the 120 days mark (median 129.5 days; range 121–153 days) and 1 patient was not offered chemotherapy (T1cN0M0) and not further documented.

Women diagnosed in 2010–2011; ≥ 18 years of age at diagnosis; first or only cancer diagnosis; primary tumor of the breast; invasive solid tumors only; no clinical or pathological evidence of metastatic disease; all or part of first course of treatment performed at Cleveland Clinic; American Joint Commission on Cancer (AJCC) stage T1c, N0, M0 or stage II or III hormone receptor-negative breast cancer.

Consideration or Administration of Tamoxifen or Third-Generation Aromatase Inhibitor Within 365 Days of Diagnosis for Women with Hormone Receptor-Positive Breast Cancer (N = 398)

2010 – 2011

Quality Measures

Cleveland Clinic standard of care quality was 97.2% (387 of 398 patients) for 2010–2011, exceeding the 90% goal established by the Commission on Cancer. Twelve patients were not treated with either chemotherapy or endocrine therapy.

Women diagnosed in 2010–2011; ≥ 18 years of age at diagnosis; first or only cancer diagnosis; primary tumor of the breast; invasive solid tumors only; no clinical or pathological evidence of metastatic disease; all or part of first course of treatment performed at Cleveland Clinic; American Joint Commission on Cancer (AJCC) stage T1c, N0, M0 or stage II or III hormone receptor-positive breast cancer.

100%100% 97.2% (n = 38)Considered or administered97.2% (n = 38)Considered or administered

2.8% (n = 12)Not considered or administered2.8% (n = 12)Not considered or administered

100%100% 91% (n = 92)Considered or administered91% (n = 92)Considered or administered

9% (n = 9)Not considered or administered9% (n = 9)Not considered or administered


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Radiation Therapy Administered Within 365 Days of Diagnosis for Women Under Age 70 Receiving Breast Conserving Surgery for Breast Cancer (N = 980)

2008 – 2011

Cleveland Clinic care quality standard was 98.3.% (963 of 980 patients) for 2008–2011, exceeding the Commission on Cancer goal of 90%. For those receiving radiation therapy, mean time to treatment was 145 days; median time to treatment was 126 days (range, 18–542 days). Of the 17 patients outside the quality of care goal, 3 patients received radiation therapy beyond 365 days from diagnosis and 14 were recommended to have radiation therapy but declined. Performance improvement opportunities include counseling and education for those declining treatment and identifying obstacles to timely treatment.

Women diagnosed in 2008–2011; < 70 years of age at diagnosis; first or only cancer diagnosis; primary tumor of the breast; invasive solid tumors only; no clinical or pathological evidence of metastatic disease; all or part of first course of treatment performed at Cleveland Clinic.

100%100% 98.3% (n = 963)Administered98.3% (n = 963)Administered

1.7% (n = 17)Not administered1.7% (n = 17)Not administered

Outcomes 2013126

Breast Disease

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127

Upper and Lower GI — Diagnostic Procedures Upper GI — Diagnostic Procedures Esophagogastroduodenoscopy

Esophagogastroduodenoscopy (EGD) is a test to examine the lining of the esophagus, stomach, and first part of the small intestine.

2011 – 2013

5000

3000

4000

0

N = 3321 3942 4041

2000

1000


2011 2012 2013


Cleveland Clinic Florida

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128

Double Balloon Enteroscopy 2011 – 2013

Endoscopic Retrograde Cholangiopancreatogram 2011 – 2013

Endoscopic Ultrasound

Endoscopic ultrasound (EUS) is increasingly used to visualize details of abdominal and esophageal structures including lymph nodes, layers of the GI tract, and vessels. EUS can be used to facilitate biopsies of areas that are inaccessible percutaneously.

2011 – 2013

400

300

0

N = 315 389 351

200

100


2011 2012 2013

200

150

0

N = 146 153 154

100

50


2011 2012 2013

200

150

0

N = 107 163 162

100

50


2011 2012 2013

Outcomes 2013128


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129

Lower GI — Diagnostic Procedure

Colonoscopy 2011 – 2013

8000

6000

0

N = 6143 6511 7119

4000

2000


2011 2012 2013


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130

Upper and Lower GI Surgical Procedures Overview

Total Procedures 2011 – 2013

Upper GI — Surgical Procedures

Esophageal and Gastric Surgical Procedures 2011 – 2013

Duodenum, Small Intestine, and Appendix Procedures 2011 – 2013

3000

0

N = 2145 2085 2443

2000

1000


2011 2012 2013

200

0

N = 118 114 148

100

150

50


2011 2012 2013

300

0

N = 192 213 266

200

100


2011 2012 2013

Outcomes 2013130


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131

Abdominal Wall and Hernia Procedures 2011 – 2013

Soft Tissue Minor Procedures 2011 – 2013

Hepatic and Pancreaticobiliary Procedures 2011 – 2013

Oncologic Retroperitoneal Procedures 2011 – 2013

600

0

N = 413 460 521

400

200


2011 2012 2013

600

0

N = 459 460 531

400

200


2011 2012 2013

160

0

N = 87 54 136

80

120

40


2011 2012 2013

160

0

N = 126 105 112

80

120

40


2011 2012 2013


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Lower GI – Surgical Procedures

Cleveland Clinic Florida Department of Colorectal Surgery diagnoses and treats a broad array of diseases including colon cancer, inflammatory bowel disease, and functional disorders such as fecal incontinence.

Rectal Cancer Surgical Procedures 2013

Ulcerative Colitis Surgical Procedures 2013

Rectal cancer surgical procedures 85

Minimally invasive procedures 35

Sphincter preservation procedures 66

Median length of stay (days) 8.8

30-day readmission rate (%) 18.8

In-hospital mortality rate (%) 0

Ulcerative colitis surgical procedures 51

Minimally invasive procedures 31

Median length of stay (days) 8.7

30-day readmission rate (%) 15.5

In-hospital mortality rate (%) 0

Outcomes 2013132


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Liver Transplant

In August 2012, the Agency for Health Care Administration approved Cleveland Clinic Florida’s Certificate of Need to provide liver and kidney transplantation services. In March 2013, the United Network for Organ Sharing granted approval of Cleveland Clinic Florida’s liver transplant program, and the program was launched in April 2013. A multidisciplinary team participates in the evaluation, management, treatment, and follow-up of the transplant patients.

Patients Referred, Evaluated, Listed, and Transplanted 2013

Liver Transplant 1-Year Patient Survival (N = 9) July 2013 – December 2013

Liver Transplant 1-Year Graft Survival (N = 9) July 2013 – December 2013

Transplants by Type of Donor Organ (N = 9) July 2013 – December 2013

aDonation after cardiac death bExpanded criteria donors cStandard criteria donors

100

80

0

60

40

20

Percent

Observed Expected

100

80

0

60

40

20

Percent

Observed Expected

160

0

N = 168 31 29

80

120

40

Number of Patients

Referred Evaluated Listed

9

Transplanted

100

40

60

80

0

20

Percent

DCDa

ECDb

SCDc


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Obesity and Metabolic Disease

The Bariatric and Metabolic Center (BMC) at Cleveland Clinic Florida has 17 full-time staff members dedicated to the care and well-being of surgical and morbidly obese patients. The American Society for Metabolic and Bariatric Surgeons, the American College of Surgeons, and the Fellowship Council have named BMC and the section of Minimally Invasive Surgery a Center of Excellence.

Bariatric Surgery Cases 2011 – 2013

Comorbidities at Baseline Among Patients Undergoing Laparoscopic Roux-en-Y Bypass (N = 199) 2011 – 2013

aMBSC = Michigan Bariatric Surgery Collaborative

Source: Carlin AM, Zeni TM, English WJ, Hawasli AA, Genaw JA, Krause KR, Schram JL, Kole KL, Finks JF, Birkmeyer JD, Share D, Birkmeyer NJ; For the Michigan Bariatric Surgery Collaborative. The comparative effectiveness of sleeve gastrectomy, gastric bypass, and adjustable gastric banding procedures for the treatment of morbid obesity. Ann Surg. 2013 May;257(5):791-797.

400

300

0

N = 263 267 310

200

100

Number of Cases

2011 2012 2013

RevisionSleeveBypassBand

CCFMBSCa

VenousThromboembolism

CurrentSmoker

Hyperlipidemia DiabetesMellitus

ObstructiveSleep Apnea

Hypertension

100

60

40

20

80

0

Percent

0

Outcomes 2013134


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Comorbidities at Baseline Among Patients Undergoing Laparoscopic Sleeve Gastrectomy (N = 434) 2011 – 2013

Laparoscopic Sleeve Gastrectomy Length of Stay 2011 – 2013




CCFMBSCa

VenousThromboembolism

Smoking Hyperlipidemia DiabetesMellitus

ObstructiveSleep Apnea

Hypertension

100

60

40

20

80

0

Percent

5

2

3

4

0

N = 94 137 201

1

Days

2011 2012 2013

Cleveland ClinicUHC U.S. News Top 10


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Laparoscopic Roux-en-Y Length of Stay 2011 – 2013

30-Day Complication Rates for All Bariatric Cases (N = 848) 2013




CCFMBSCa

RespiratoryFailure

Deep VeinThrombosis

Bleeding IntestinalObstruction

Wound Infection/Evisceration

AnastomoticLeak

4

2

1

3

0

Percent

0

5

2

3

4

0

N = 107 73 49

1

Days

2011 2012 2013

Cleveland ClinicUHC U.S. News Top 10

Outcomes 2013136


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Breast Disease

Cleveland Clinic Florida offers a diagnostic callback program for patients with abnormal screening mammograms. The callback rate has increased slightly during the past 2 years since digital mammography was introduced, but has been close to 15% for several years. This is consistent with the National Comprehensive Cancer Network benchmark of 5% to 15%.

Screening Mammograms Resulting in Callback 2011 – 2013

20

0

N = 9441 9865 11,756

10

15

5

Percent

2011 2012 2013

The breast conservation rate is 57%. This exceeds the National Accreditation Program for Breast Centers ideal benchmark of 50% for breast conservation surgery in patients with stage 0, 1, or 2 breast cancer.

Surgery for Breast Cancer 2010 – 2012

MastectomyLumpectomy

100

75

0

N = 117 102 113

50

25

Percent

2010 2011 2012


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138

The core biopsy rate exceeds the National Quality Forum benchmark of 90%.

aThe American College of Surgeons Commission on Cancer’s Cancer Program Practice Profile Report

Breast cancer patients < 70 years of age who had lumpectomy also had radiation therapy within 1 year. The American College of Surgeons Commission on Cancer’s Cancer Program Practice Profile Report (ACoS/CoC CP3R) benchmark is 90%.

Biopsies Performed 2010 – 2012

Radiation Therapy After Lumpectomy 2010 – 2012

Cleveland ClinicACoS/CoC CP3Ra

100

75

0

N = 33 33 55

50

25

Percent

2010 2011 2012

Excisional biopsyCore needle biopsy

100

75

0

N = 127 133 139

50

25

Percent

2010 2011 2012

Outcomes 2013138


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139

Tamoxifen or third generation aromatase inhibitors were administered within 1 year of diagnosis for > 70% of women with American Joint Committee on Cancer (AJCC) stage T1c, or stage 2 or 3 hormone receptor positive breast cancer. ACoS/CoC CP3R benchmark is 90%.

Combination chemotherapy was administered within 4 months for women < 70 years of age with AJCC stage T1c, or stage 2 or 3 hormone receptor negative breast cancer. ACoS/CoC CP3R benchmark is 90%.

Tamoxifen or Third Generation Aromatase Inhibitor Within 1 Year of Diagnosis 2010 – 2012

Combination Chemotherapy Within 4 Months 2010 – 2012




100

75

0

N = 33 33 55

50

25

Percent

2010 2011 2012


100

75

0

N = 12 10 20

50

25

Percent

2010 2011 2012


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Despite performing complex abdominal and colorectal surgical procedures, the Digestive Disease Institute’s postoperative hemorrhage or hematoma rates (AHRQ Patient Safety Indicator 9) have steadily improved since 2010.

Collaboration with the Intensive Care Unit staff has resulted in a 28% decrease in postoperative respiratory failure rates (AHRQ Patient Safety Indicator 11).

Digestive Disease Institute Postoperative Hemorrhage or Hematoma (PSI 9) January 2010 – November 2013

Digestive Disease Institute Postoperative Respiratory Failure (PSI 11) January 2010 – November 2013

aThe Cleveland Clinic target is 1.8 per 1000 patients (90th percentile). These data are prepared using the University Health System Consortium (UHC) Clinical Database. (uhc.edu)


Digestive Disease Institute Patient Safety Indicators

The Agency for Healthcare Research and Quality’s (AHRQ) Patient Safety Indicators (PSI) are used to measure patient safety in hospitals. The Digestive Disease Institute has made great improvements in identifying potential complications or adverse events through efforts that align clinical care with documentation.

00

1616

44

88

1212

Rate per 1000 PatientsRate per 1000 Patients

2010 2011 2012 2013

Digestive Disease Institute performanceCleveland Clinic targeta

00

18181515

6633

991212


2010 2011 2012 2013


Outcomes 2013140

Institute Quality Improvement

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141

Digestive Disease Institute Postoperative Pulmonary Embolism or Deep Vein Thrombosis (PSI 12) January 2010 – November 2013

Digestive Disease Institute Postoperative Sepsis (PSI 13) January 2010 – November 2013


Reducing the incidence of postoperative pulmonary embolism or deep vein thrombosis (AHRQ Patient Safety Indicator 12) continues to be an area of focus and priority for improvement. There was an 18% decrease in the rate per 1000 patients from 2012 to 2013.


Collaboration with the Intensive Care Unit staff resulted in a steady decrease of postoperative sepsis (AHRQ Patient Safety Indicator 13) since 2010.

00

2828

2020

44

1212

2424

1616

88



2010 2011 2012 2013

00

1212

99

33

66


2010 2011 2012 2013



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Digestive Disease Institute Postoperative Wound Dehiscence (PSI 14) January 2010 – November 2013

Digestive Disease Institute Accidental Puncture or Laceration (PSI 15) January 2010 – November 2013

aThe Cleveland Clinic target is 0 per 1000 patients (90th percentile). These data are prepared using the University Health System Consortium (UHC) Clinical Database. (uhc.edu)

Despite performing complex primary and reoperative abdominal and colorectal surgical procedures, the Digestive Disease Institute’s postoperative wound dehiscence rate the Agency for Healthcare Research and Quality’s (AHRQ) Patient Safety Indicators (PSI) 14 is low at 1 per 1000 patients.


In spite of a large number of reoperative cases, the accidental puncture or laceration rates (AHRQ Patient Safety indicator 15) have dramatically decreased since 2010 and were sustained at a rate below 5 per 1000 patients in 2013.

00

2.02.0

0.50.5

1.01.0

1.51.5


2010 2011 2012 2013


00

5050

2020

1010

3030

4040


2010 2011 2012 2013


Outcomes 2013142


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143

Readmission rates by department have been consistent since 2011. A process to review all unplanned readmissions was implemented to gain insight and identify improvement opportunities.

Digestive Disease Institute All Cause 30-Day Readmissions by Department 2011 – 2013

00

3030

1010

2020

PercentPercent

20122011 2013

BariatricsColorectal surgeryGastroenterology &HepatologyGeneral surgery

Digestive Disease Institute Readmissions


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Patients Receiving Pain Assessments 2013

atotal number of colorectal patients taking part in the pain assessment quality initiative

Increasing Pain Assessments Using A Time Tracker Devise for Colorectal Patients

To improve postoperative pain management on colorectal surgery units, a color-coded Time-Tracker® device was implemented. The device is available to every nurse upon administration of narcotics/opioids and indicates when a patient last received pain medication and promps for reassessment and redosing of pain medication. The pilot resulted in an increase in the percentage of pain reassessments completed and improved HCAHPS scores.

100

80

60

0

Na =

40

20

Percent

8/22

59

9/30

68

10/13

83

9/23(Pilot

Implementation)

82

10/7

44

11/4

101

Patient IPC Compliance 2013

atotal number of patients taking part in the IPC quality initiative

Digestive Disease Institute Quality Initiatives to Improve Outcomes

Deep Vein Thrombosis Prevention - Inpatient Intermittent Pneumatic Compression Boot

To improve compliance with the use of intermittent pneumatic compression (IPC) patients’ usage of IPC was documented hourly. Hourly documentation resulted in increased compliance.

00

7070

5050

1010

3030

6060

4040

2020

PercentPercent

100% hourlydocumentation compliance80% IPC wear compliance

Na =

Q1

60

Q2(Pilot

Implementation)

85

Q3

68

Q4

61

Outcomes 2013144


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Pain Scale Pre- and Posttherapy (N = 76) 2013

Anxiety Scale Pre- and Posttherapy (N = 32) 2013

aPain Management refers to the HCAHPS question “During this hospital stay, how often did the hospital staff do everything they could to help you with your pain”? bResponse options: Always, Usually Sometimes, Never; Scores represent the percent of patients who responded “Always”. ctotal number of patients taking part in the pain management HCAHPS survey

Impact of Relaxation Therapy on Transplant Patients’ Postoperative Pain and Anxiety

In July 2013, a pilot relaxation therapy program was launched on the abdominal transplant nursing floor consisting of noninvasive stretching, breath work, and imagery. Patients showed a decrease in both pain and anxiety following therapy. A total of 76 patients have participated in the program to date. Pain scores and anxiety scores were recorded pre and postsession. The scales are 0–10 with 1 indicating no pain or anxiety and 10 indicating severe pain or anxiety. This is the first program of this type in the US.

Pain Managementa HCAHPS Scores Following Pain Assessment Pilot

Following the initiation of the pain assessment pilot, colorectal surgery patients’ responses to their Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) surveys reflected an increased sentiment that “staff did everything to help with pain.”

2013

654

0

321

Pain Score

Pretreatment Posttreatment

654

0

321

Anxiety Score

Pretreatment Posttreatment

7676

9090

8686

7878

8282

8888

8484

8080

PercentPercent

Staff pain managementTarget

Nc =

Q1

107

Q2

91

Q3(Pilot

Implementation)

88

Q4

88


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American College of Surgeons National Surgical Quality Improvement Program

The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP®) objectively measures and reports risk-adjusted surgical outcomes based on a defined sampling and abstraction methodology. These outcomes data reflect Cleveland Clinic’s ACS NSQIP performance benchmarked against more than 400 participating hospitals.

aIdentified as a statistical outlier by the ACS NSQIP hierarchical model

Outcome N Observed Rate (%) Expected Rate (%) Statistical Outliera

30-day mortality 4682 1.05 1.25

30-day morbidity 4682 10.49 9.31 High

Surgical Care Improvement Program (SCIP) — Appropriateness of Care

Cleveland Clinic Overall Multispecialty 30-Day Mortality and 30-Day Morbidity July 2012 – June 2013

Cleveland Clinic’s goal is for all patients to receive all the recommended care that is appropriate. An aggregated “all or nothing” measurement approach to monitoring multiple publicly reported surgical measures trended positively in 2013.

This composite metric, based on a group of hospital surgical quality process measures developed by the Centers for Medicare & Medicaid Services, shows the percentage of patients who received all the recommended care for which they were eligible.

0

60

80

100

40

20

Percent

Source: medicare.gov/hospitalcompare

Cleveland Clinic target

2012 2013

N = 1293 880

93.0 93.3

Outcomes 2013146

Surgical Quality Improvement

Cleveland Clinic Surgical Appropriateness of Care 2012 – 2013

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General Surgery Outcomes July 2012 – June 2013

Colorectal Surgery Outcomes July 2012 – June 2013

In addition to overall surgical performance, ACS NSQIP data specific to general surgery and to colorectal surgery are shown in the tables below.




30-day mortality 1163 1.03 1.15

30-day morbidity 1163 15.74 13.69 High

Cardiac arrest/myocardial infarction 1163 0.52 0.77 Low

Pneumonia 1161 1.98 1.79

Unplanned intubation 1161 2.07 1.55

Ventilator > 48 hours 1157 2.25 1.58

Deep vein thrombosis/pulmonary embolism 1163 2.67 1.42 High

Renal failure 1163 1.20 0.91

Surgical site infection 1153 9.80 7.83 High

Urinary tract infection 1161 1.98 1.75

Return to operating room 1163 4.47 3.89


30-day mortality 402 1.00 1.06

30-day morbidity 402 19.90 18.42

Surgical site infection 399 12.78 11.60

Urinary tract infection 401 4.24 2.74 High

Return to operating room 402 5.72 5.22


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Outpatient Office Visit Survey — Digestive Disease Institute

Patient Experience — Digestive Disease Institute

Cleveland Clinic is dedicated to delivering excellent clinical outcomes surrounded by the best possible experience for patients and their families. Reported patient experiences are shared with caregivers and used to identify opportunities to improve care. Cleveland Clinic’s Office of Patient Experience supports caregivers through educational opportunities and training programs designed to help them provide the best possible experience in every patient encounter.

CG-CAHPS Assessmenta (2981) 2013

aIn 2013, Cleveland Clinic began administering the Clinician and Group Practice Consumer Assessment of Healthcare Providers and Systems surveys (CG-CAHPS), standardized instruments developed by the Agency for Healthcare Research and Quality and supported by the Centers for Medicare & Medicaid Services for use in the physician office setting to measure patients’ perspectives of outpatient care. bBased on results submitted to the CAHPS database from 2399 medical practices in 2012.cData and benchmark based on results of the CG-CAHPS Visit-Specific survey submitted to the CAHPS database from 2399 medical practices in 2012.

Source: Press Ganey, a national hospital survey vendor

100

80

0

60

40

20

Percent Best Response

AppointmentAccess

DoctorCommunication

Doctor Rating Clerical Staffc Test ResultsCommunicationc

CAHPS Database Average(All Practicesb)

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Inpatient Survey — Digestive Disease Institute

HCAHPS Overall Assessment 2012 – 2013

The Centers for Medicare & Medicaid Services requires United States hospitals that treat Medicare patients to participate in the national Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, a standardized tool that measures patients’ perspectives of hospital care. Results collected for public reporting are available at medicare.gov/hospitalcompare.

HCAHPS Domains of Care 2012 – 2013

100

80

0

60

40

20


aResponse options: Definitely Yes, Probably Yes, Probably No, Definitely No


2013 (N = 1939)

National AverageAll Patientsb

2012 (N = 2002)

Hospital Rating(% 9 or 10)0 – 10 Scale

77 80

Recommend Hospital(% Definitely Yes)a

8483

100

80

0

60

40

20

Percent Best Responsea

DischargeInformation

% Yes

Doctor Communication

Nurse Communication

PainManagement

RoomClean

New MedicationsCommunication

Responsivenessto Needs

Quiet atNight

% Always(Options: Always, Usually, Sometimes, Never)

2013 (N = 1939)

National Average All Patientsb

2012 (N = 2002)

aExcept for “Room Clean” and “Quiet at Night,” each bar represents a composite score based on responses to multiple survey questions. Source: Press Ganey, a national hospital survey vendorbBased on national survey results of discharged patients, April 2012 – March 2013, from 3938 US hospitals. medicare.gov/hospitalcompare

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Cleveland Clinic Overall Mortality Observed/Expected Ratio

2012 – 2013

aThese data are prepared using the University HealthSystem Consortium (UHC) Clinical Database. uhc.edu

Cleveland Clinic’s observed/expected (O/E) mortality ratio outperformed the University HealthSystem Consortium (UHC) academic medical center 50th percentile throughout 2013 based on the UHC 2013 risk model. Ratios less than 1.0 indicate mortality performance “better than” expected in UHC’s risk adjustment model.

Overview

Cleveland Clinic health system uses a systematic approach to performance improvement while simultaneously pursuing three goals: improving the patient experience of care (including quality and satisfaction), improving population health, and reducing the cost of healthcare. The following measures are examples of 2013 focus areas in pursuit of this three-part aim. Throughout this section, “Cleveland Clinic” refers to the academic medical center or “main campus,” and those results are shown. Real-time dashboard data are leveraged in each Cleveland Clinic location to drive performance improvement. Although not an exact match to publicly reported data, more timely internal data create transparency at all organizational levels and support improved care in all clinical locations.

1.0

0.0Q1 Q2

2012 2013

Q3 Q4 Q1 Q2 Q3 Q4

0.8

0.6

0.4

0.2

O/E Ratio

Cleveland ClinicUHCa Academic Medical Center50th Percentile (2013)

Cleveland Clinic has implemented several strategies to reduce central line-associated bloodstream infections (CLABSIs), including a central-line bundle of insertion, maintenance, and removal best practices. Focused reviews for every CLABSI occurrence support reductions in CLABSI rates in the high-risk critical care population.

Cleveland Clinic Central Line-Associated Bloodstream Infection — ICU Rate per 1000 Line Days

2012 – 2013

2.5

0.0

2.0

1.5

1.0

0.5

Rate per 1000 Line Days

Cleveland Clinic PerformanceCleveland Clinic Target

Q1 Q2

2012 2013

Q3 Q4 Q1 Q2 Q3 Q4

Improve the Patient Experience of Care

Cleveland Clinic — Implementing Value-Based Care

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Cleveland Clinic Postoperative Pulmonary Embolism or Deep Vein Thrombosis Risk Adjusted Rate per 1000 Eligible Patients

2012 – 2013

Improved screening and prevention strategies have supported Cleveland Clinic’s continued improvement with respect to postoperative pulmonary embolism and deep vein thrombosis (AHRQ Patient Safety Indicator 12). Embolism/thrombosis prevention remains a safety priority for Cleveland Clinic in 2014.

aData reported from the National Database for Nursing Quality Indicators® (NDNQI®) with permission of the American Nurses Association

aThese data are prepared using the University HealthSystem Consortium (UHC) Clinical Database. uhc.edu

10

0

2012 2013

Q3 Q4 Q1 Q2 Q3 Q4

8

6

4

2

Rate per 1000 Patients

Cleveland ClinicUHCa Academic Medical Center50th Percentile

A pressure ulcer is an injury to the skin that can be caused by pressure, moisture, or friction. Cleveland Clinic caregivers have been trained to provide appropriate skin care preventive measures, which include patient repositioning and the use of special devices and mattresses to reduce pressure for high-risk patients. In addition, they actively identify hospital-acquired pressure ulcers through daily nursing assessments and, in collaboration with the multidisciplinary team, implement early treatment recommendations.

Cleveland Clinic Hospital-Acquired Pressure Ulcer Prevalence (Adult)

2012 – 2013

5

0

4

3

2

1

Percent

Cleveland ClinicNDNQI 50th Percentile(academic medical centers)a

Q1 Q2

2012 2013

Q3 Q4 Q1 Q2 Q3 Q4

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Cleveland Clinic is dedicated to delivering excellent clinical outcomes surrounded by the best possible experience for patients and their families. Reported patient experiences are shared with caregivers and used to identify opportunities to improve care. Cleveland Clinic’s Office of Patient Experience supports caregivers through educational opportunities and training programs designed to help them provide the best possible experience in every patient encounter.

Outpatient Office Visit Survey — Cleveland Clinic

CG-CAHPS Assessmenta (N = 64,463) 2013

100

80

0

60

40

20


AppointmentAccess

Specialty CarePrimary Care


Doctor Rating Clerical Staff Test ResultsCommunication

CAHPS Database Average(All Practicesb)

aIn 2013, Cleveland Clinic began administering the Clinician and Group Practice Consumer Assessment of Healthcare Providers and Systems surveys (CG-CAHPS), standardized instruments developed by the Agency for Healthcare Research and Quality and supported by the Centers for Medicare & Medicaid Services for use in the physician office setting to measure patients’ perspectives of outpatient care. bBased on results submitted to the CAHPS database from 2399 medical practices in 2012.


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HCAHPS Overall Assessment 2012 – 2013

Inpatient Survey — Cleveland Clinic

The Centers for Medicare & Medicaid Services requires United States hospitals that treat Medicare patients to participate in the national Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, a standardized tool that measures patients’ perspectives of hospital care. Results collected for public reporting are available at medicare.gov/hospitalcompare.

HCAHPS Domains of Care 2012 – 2013

100

80

0

60

40

20


aResponse options: Definitely Yes, Probably Yes, Probably No, Definitely No


2013 (N = 10,671)

National AverageAll Patientsb

2012 (N = 11,254)

Hospital Rating(% 9 or 10)0 – 10 Scale

82 82

Recommend Hospital(% Definitely Yes)a

8686

100

80

0

60

40

20

Percent Best Responsea

DischargeInformation

% Yes


Nurse Communication

PainManagement

RoomClean

New MedicationsCommunication

Responsivenessto Needs

Quiet atNight

% Always(Options: Always, Usually, Sometimes, Never)

2013 (N = 10,671)

National Average All Patientsb

2012 (N = 11,254)

aExcept for “Room Clean” and “Quiet at Night,” each bar represents a composite score based on responses to multiple survey questions.

Source: Press Ganey, a national hospital survey vendorbBased on national survey results of discharged patients, April 2012 – March 2013, from 3938 US hospitals. medicare.gov/hospitalcompare

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Cleveland Clinic is developing and implementing new models of care that focus on “Patients First” and aim to deliver on the Institute of Medicine goal of Safe, Timely, Effective, Efficient, Equitable, Patient-centered care. Creating new models of Value-Based Care is a top strategic priority for Cleveland Clinic as healthcare reform moves care delivery from fee-for-service to a population health and bundled payment delivery system, while concurrently improving patient safety, outcomes, and experience. What will our new model of care look like?

• The Cleveland Clinic Integrated Care Model is a value-based model of care, designed to improve outcomes while reducing cost.

• The patient remains at the heart of the Cleveland Clinic Integrated Care Model.

• The blue band represents the care system, which is a seamless pathway that patients move along as they receive care in the different settings listed. The care system represents integration of care across the continuum.

• To build this new care system, critical competencies are care paths and care coordination. We have therefore begun to build disease and condition-specific care paths, and are implementing comprehensive care coordination.

• Care paths guide patient care both within a venue (e.g., a hospital) as well as along the care system (blue band) to appropriate care venues. Care paths will improve value by employing evidence and/or experience-based practice to reduce unnecessary variation in care, with the goal of achieving optimal outcomes at the lowest possible cost. Measurement of use and outcomes is integral to care paths.

• Care coordination identifies high-risk patients and risk points in transitions of care, and enhances communication and handoffs between providers and locations.

Focus on Value

HomeRetail Venues

Integrated Care Model

Outpatient Clinics

IndependentPhysicianOffices

Skilled NursingFacilities Rehabilitation

Facilities

Community-BasedOrganizations

Post-Acute(other)

AmbulatoryDiagnosis & Treatment

Hospitals

Emergency

Care System

MyChart


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aThese data are prepared using the University HealthSystem Consortium (UHC) Clinical Database. uhc.edu bN = Total discharges

Cleveland Clinic All-Cause 30-Day Readmission Rate to Any Cleveland Clinic Hospital

2012 – 2013

Improved Health-Related Quality of Life with Implementation of Stroke Care Path (N = 480)

2009 – 2012

Cleveland Clinic monitors 30-day readmission rates for any reason to any of its system hospitals. Unplanned readmissions are actively reviewed for improvement opportunities. Strategies associated with communication, education, and follow-up have been implemented for several high-risk conditions, including heart failure and pneumonia. These practices are being expanded and enhanced to reduce overall avoidable readmissions. Sicker, more complex patients are more susceptible to readmission. Case mix index (CMI) reflects patient severity. Cleveland Clinic’s CMI remains one the highest among American Academic Medical Centers.

In the future, value will be increasingly focused on measures such as the patient’s functional status, rather than on traditional outcomes measures. The stroke care path measure below is an example.

The Ischemic Stroke Care Path, spanning the in-hospital and ambulatory settings, was implemented in 2010. Health-related quality of life, defined by the EQ-5D and measured in the ambulatory setting, has shown greater improvements since implementation of the care path.

aAs measured between first and last visit in the same year and adjusted for age, gender, race, marital status, and socioeconomic status. bPatients with perfect self-reported health-related quality of life (EQ-5D index = 1.0) were excluded from the analysis.

Reduce the Cost of CareImprove Population Health

Percent of DischargesPercent of Discharges Case Mix Index

0.0

3.0

1.5

00

2020

1010

1515

55

Q1 Q2

201251,991Nb =

201352,104

Q3 Q4 Q1 Q2 Q3 Q4

Cleveland Clinic RateCleveland Clinic CMIUHCa Academic Medical Centers CMI

0.030.03

A positive score indicates stable status or improvementA positive score indicates stable status or improvement

0.090.09

0.080.08

0.050.05

0.060.06

0.070.07

0.040.04

Mean Difference in EQ-5DaMean Difference in EQ-5Da

200946

Stroke Care Path

Nb =2011199

2010122

2012113

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Chronic Antibiotic-Refractory Pouchitis

AutoimmuneDisorders

Autoinflammatory Disorders

PSCa, IgG4 Diseases“GVHD”b-like

156 Outcomes 2013

Innovations

Classification System Improves Endoscopic Therapy of Inflammatory Bowel Disease

Cleveland Clinic Digestive Disease Institute (DDI) gastroenterologists have developed a classification system and management algorithm for strictures and fistulae related to inflammatory bowel disease. Using several specific criteria, including stricture length, location, and etiology, the system classifies strictures and fistulae following their endoscopic or radiographic evaluations. The novelclassification system was published in Paine E, Shen B. Endoscopic therapy in inflammatory bowel disease (with videos). Gastrointest Endosc. 2013;78(6):819–835.

Classification of Immune-Mediated Pouchitis Provides Insight Into Management, Prognosis

Restorative proctocolectomy with ileal pouch-anal anastomosis has become the surgical treatment of choice for most patients with ulcerative colitis who require proctocolectomy; however, adverse sequelae of mechanical, inflammatory, functional, neoplastic, and metabolic conditions related to the pouch can occur postoperatively.

DDI gastroenterologists recently proposed a new disease category: immune-mediated pouchitis, as opposed to conventional dysbiosis- or pathogen-associated pouchitis. The subcategories of immune-mediated pouchitis are:

• Primary sclerosing cholangitis-associated pouchitis/enteritis

• IgG4-associated pouchitis

• Autoinflammatory-disorder-associated pouchitis

• Graft-vs-host-like pouchitis

The description of immune-mediated pouchitis has clinical implications for management and prognosis. The disease classification was published in Seril DN, Yao Q, Shen B. The association between autoimmunity and pouchitis. Inflamm Bowel Dis. 2014;20(2):378-388.

aPrimary sclerosing cholangitis bGraft vs host disease

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Novel Bear Claw Approach Offers Nonsurgical Repair of J Pouch Leak

Cleveland Clinic gastroenterologists have pioneered a novel endoscopic management of a leaking J pouch, using a bear claw closure instrument. Leaks from the tip of a J pouch are not unusual but may increase the risk for pouch failure as the symptoms are nonspecific and difficult to diagnose. Typically, J pouch leaks are managed surgically. This over-the-top clipping system may reduce medical costs and the risks of surgical procedures. The technique was reported in Lian L, Shen B. Closure of leak at the tip of the “J” after ileal pouch-anal anastomosis using a novel over-the-scope clipping system. J Coloproctol. In press.

Three-Dimensional Liver Models Improve Surgical Planning

Working with the Medical Device Unit, Cleveland Clinic hepatologists have built more than 20 liver models replicating individual patient livers using advanced three-dimensional (3D) printing technologies. The models are made of a flexible resin with internal lumen geometry generated from a reconstructed CT scan. The printed liver is made of transparent material for direct visualization of vascular and biliary anatomical structure, and thus allows for better planning of complex liver surgeries, including live-donor liver transplantation. The preoperative identification of the vascular and biliary tract anatomy with 3D printing can also prevent unnecessary surgery in patients with potentially unsuitable anatomy.

These models were used to plan and provide real-time guidance during surgery for three living donors and their respective recipients who underwent living-donor liver transplantation.

Online Tool Facilitates Personal Colon Cancer Risk Assessment

In an effort to encourage those at risk for colon cancer to consider undergoing colonoscopy, Cleveland Clinic has developed clevelandclinic.org/score, an innovative online tool for the self-assessment of cancer risk. DDI markets the tool using social media channels, employee events, online articles, and a variety of educational materials. In 2013, more than 4500 people completed the assessment. Of those, 309 patients underwent at least one colonoscopy in the same year. Since the site’s inception in March 2010, nearly 20,000 visitors have completed the assessment.

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158 Outcomes 2013

Innovations

Device Controls Upper GI Bleeding

Hemospray is approved for control of upper GI bleeding in Europe and Canada but not in the United States. Cleveland Clinic gastroenterologists are currently using the agent off-label for compassionate care in patients with upper GI bleeding not amenable to other endoscopic therapies.

Hemospray is a powder, sprayed through a catheter that is passed through an endoscope. The mechanism of action is thought to occur by:

• Physical adherence to the damaged tissue and sealing injured blood vessels to prevent further blood loss

• Rapid absorption of water from blood, which concentrates all clotting elements on the injured tissue

• A chemical reaction that activates platelets and the intrinsic coagulation pathway to promote clot formation

ELAD Therapy May Affect Survival of Patients With Alcohol-Induced Liver Decompensation

Cleveland Clinic hepatologists are participating in a multicenter study evaluating the safety and efficacy of modified extracorporeal liver assist device (ELAD®) therapy to determine overall survival of patients with a clinical diagnosis of alcohol-induced liver decompensation (AILD).

ELAD is a biologic-device therapy, containing a blood pump and four metabolically active bioreactors through which a patient’s plasma is circulated. Toxins found in the ultrafiltrate diffuse across the semipermeable membrane where they can be metabolized by C3A cells. These metabolites, along with albumin and other beneficial proteins synthesized by the cells, diffuse back across the membrane into the intracapillary space and are returned to the patient.

Patients will be randomly assigned to:

• Standard of care treatment for AILD plus treatment with ELAD

• Standard of care treatment for AILD alone

Endoscopic Device Improves Accuracy of Esophageal Disease Detection

Cleveland Clinic is one of the few large centers employing the NvisionVLE™ Imaging System from NinePoint Medical to evaluate the esophageal microstructure using optical coherence tomography (OCT) during endoscopy. This technology captures a cross-sectional scan of the esophagus to 3 mm beneath the mucosa, at a resolution of 7 µm. Using high-speed OCT, the device incorporates rotation and pullback of the optics, scanning 6 cm of the esophagus in 90 seconds.

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0.0 0.2 0.4

TMA + Acetone + Pentane (0.93)TMA (0.89)Acetone (0.78)Pentane (0.72)

0.6

z-Specificity

Sens

itivi

ty

0.8 1.00.0

0.2

0.4

0.6

0.8

1.0


Breathprints Identify Novel Biomarkers in Alcoholic Hepatitis

Selected-ion flow-tube mass spectrometry (SIFT-MS) can achieve precise identification of trace gases in the human breath in the parts per billion range. Cleveland Clinic hepatologists, in collaboration with the pulmonary team, identified six volatile organic compounds in the breath in patients with liver disease compared with healthy subjects. Of those compounds, trimethylamine (TMA), acetone, and pentane in the exhaled breath were remarkably higher in patients with alcoholic hepatitis (AH) in particular. The hepatology team developed a model for the diagnosis of AH that includes the breath levels of TMA, acetone, and pentane. The breathprint may provide a noninvasive method for the diagnosis of AH as well as have independent prognostic value in these patients.

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160 Outcomes 2013

Innovations

Collaborative Developmental Endoscopy Group Works on Device Development, Training Initiatives, Less Invasive Techniques

Stent placement allows for a minimally invasive endoscopic repair of anastomotic complications following bariatric surgery. This technique avoids revisional surgery, which often results in significant morbidity. A recent Cleveland Clinic study assessed 18 patients who underwent endoscopic stent placement for surgical anastomotic complications including leaks, strictures, and fistulae. All but two patients showed symptomatic improvement,

and stent placement was successful in definitively managing the anastomotic complication in 13 of the 18 patients. Five patients required additional surgical or endoscopic intervention. Stent migration occurred in four patients, who were treated successfully with endoscopic management.

The Developmental Endoscopy Group formed this past year. Three initiatives are described below.

The group also completed the first endoscopic, full-thickness, gastric tumor excision and endoscopic submucosal dissection for gastric adenocarcinoma, providing a less invasive way of removing gastric tumors. Both tumors were resected completely. The patients are

now disease-free and were discharged within 23 hours.

In December 2013, the Developmental Endoscopy Group completed its first peroral endoscopic myotomy (POEM) procedure, a new surgical treatment for achalasia and other esophageal disorders. Typically, achalasia is treated using a minimally invasive technique that requires several small cuts in the abdomen. POEM obviates the need for incision by using a small knife passed through an endoscope that makes a small slit in the lining of the esophagus to reach the sphincter muscle. Once the blockage is cleared, the endoscope is removed, and the slit is repaired. Patients experience little-to-no pain, resulting in faster recovery.

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Novel Intestinal Stroke Program Aims to Preserve Patients’ Intestines

The intestinal stroke program is a multidisciplinary approach to treating patients with intestinal ischemia by a team of gastroenterologists, hematologists, radiologists, and surgeons with the goal of preserving patients’ intestines. The program, led by the Center for Gut Rehabilitation and Transplantation, is establishing an algorithmic protocol for managing patients and working closely with the Acute Care Surgery team to triage intestinal stroke patients who arrive through the Emergency Department.

Multi-Institution Registry Offers Analysis of Intraoperative Radiation Therapy for Breast Cancer

Cleveland Clinic has recently established and currently maintains the largest retrospective data collection registry for patients treated with intraoperative radiation therapy (IORT) in North America. IORT is an alternative form of radiation for early stage breast cancer patients with a favorable prognosis. A single dose of radiation is delivered to the lumpectomy site at the time of surgery, rather than the traditional treatment of daily radiation to the whole breast for 6 weeks. Patients undergoing this therapy have their surgical and radiation treatment completed with a single trip to the operating room. The registry includes more than 20 centers across the country and is a collaborative effort aimed at documenting long-term recurrence outcomes and safety.

MyFamily Collects Family Health History Prior to Appointment

MyFamily, a clinical decision support application built by Cleveland Clinic, enables collection of patient-entered personal and family health history through a MyChart invitation before a scheduled encounter. MyFamily then integrates a disease risk reference document into the electronic medical record at the point-of-care, which represents stratified disease-risk scores along with evidence-based, clinically actionable recommendations. MyFamily facilitates clinicians optimizing their encounter time, allowing them to focus on creating personalized preventive care plans and maximizing the quality of care for patients. In collaboration with the Genomic Medicine Institute, DDI is using the program for the first time with breast cancer and colon cancer patients.

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162 Outcomes 2013

Innovations

Endoscopic mucosal resection/endoscopic submucosal dissection (EMR/ESD) reduces complications in resection of challenging colonic lesions, which require advanced endoscopic techniques. Currently, with few exceptions, gastroenterologists refer large, benign, sessile colonic polyps to surgeons for segmental colorectal resections. ESD technique allows the intact removal of polyps and large intraluminal lesions (“en bloc”), which permits precise pathological assessments of resection. DDI colorectal surgeons successfully performed the EMR/ESD technique in more than 26 patients with insignificant complications. Initial experience proves that ESD is feasible and effective and can avoid unnecessary oncologic segmental bowel resections.

Data Warehouse Enhances Quality Analysis

DDI has developed a data warehouse storing electronic medical records (EMR) on more than 700,000 patients. These data provide information on laboratory reports, medications, admissions and discharges, operative reports, all encounter notes, diagnoses, and patient demographics. Natural language processing parses textual notes into discrete parameters, capitalizing on the use of Epic SmartSets and other structured text within the EMR.

Users are able to query data across the population; integrated architecture aligns data into more usable and intuitive results. The warehouse will provide information on quality-of-care measures and monitoring for adherence to clinical pathways. Eventually, the data warehouse will be used to guide clinical decisions, building on the collective knowledge gained from the EMR.

Combination Technique Reduces Complications in Resection of Colonic Lesions

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Combined Endoscopic and Laparoscopic Surgery Avoids Bowel Resection

For difficult colonic lesions, Cleveland Clinic colorectal surgeons perform laparoscopic mobilization of the colon with combined intraoperative CO2 colonoscopy. A new combined laparoendoscopic approach allows removal of difficult colonic lesions that avoids formal bowel resection. Combined endoscopic and laparoscopic surgery is safely offered to selected patients with benign polyps or early colonic neoplasms that could not be removed by colonoscopy alone.

DDI Pioneers Techniques to Prevent Anastomotic Leaks Following Colorectal, Bariatric Surgeries

Good blood perfusion at the anastomotic site is the key factor in decreasing clinically apparent, anastomotic problems, which can occur in up to 20% of patients after all colorectal resections. Cleveland Clinic colorectal surgeons have been using objective measurement of tissue perfusion with a near infrared (NIR) endoscopic imaging system, instead of macroscopic appraisal of the tissue. A specialized endoscopic camera and light source capable of acquiring high-definition, white light images and NIR angiographic images constitute this system. Transanal imaging with direct evaluation of the anastomosis is also achieved by using this new technology through a rigid rectoscope.

Enhanced robotic visualization developed at Cleveland Clinic can also identify potential anastomotic leaks following bariatric surgery. Using contrast injected into a patient’s bloodstream, the robot views the blood supply in any organ with contrast via infrared light, allowing the surgeon to see inconsistencies and treat the anastomosis before it leaks.

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Outcomes 2013164

Contact Information

Outcomes 2013

Colorectal Surgery, Gastroenterology and Hepatology, and General Surgery Appointments/Referrals

800.223.2273, ext. 47000

Bariatric Surgery Appointments/Referrals

216.445.2224 or

800.223.2273, ext. 52224

Breast Center Appointments/Referrals

800.223.2273, ext. 43024

Center for Human Nutrition Appointments/Referrals

800.223.2273, ext. 43046

Cleveland Clinic Florida Appointments

877.463.2010

On the Web at clevelandclinic.org/digestive and clevelandclinic.org/bariatric

Staff Listing

For a complete listing of Cleveland Clinic’s Digestive Disease Institute staff, please visit clevelandclinic.org/staff.

Publications

Digestive Disease Institute staff authored 495 publications in 2013.

For a complete list, go to clevelandclinic.org/outcomes.

Locations

For a complete listing of Digestive Disease Institute locations, please visit clevelandclinic.org/digestive.

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Additional Contact Information General Patient Referral

24/7 hospital transfers or physician consults

800.553.5056 General Information

216.444.2200 Hospital Patient Information

216.444.2000 General Patient Appointments

216.444.2273 or 800.223.2273 Referring Physician Center and Hotline

855.REFER.123 (855.733.3712)

Or email [email protected] or visit clevelandclinic.org/refer123 Request for Medical Records

216.444.2640 or 800.223.2273, ext. 42640 Same-Day Appointments

216.444.CARE (2273)

Global Patient Services/ International Center

Complimentary assistance for international patients and families

001.216.444.8184 or visit clevelandclinic.org/gps Medical Concierge

Complimentary assistance for out-of-state patients and families

800.223.2273, ext. 55580, or email [email protected] Cleveland Clinic Abu Dhabi

clevelandclinicabudhabi.ae Cleveland Clinic Canada

888.507.6885 Cleveland Clinic Florida

866.293.7866 Cleveland Clinic Nevada

702.483.6000 For address corrections or changes, please call

800.890.2467


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Overview

Cleveland Clinic is an academic medical center offering patient care services supported by research and education in a nonprofit group practice setting. More than 3,200 Cleveland Clinic staff physicians and scientists in 130 medical specialties and subspecialties care for more than 5.5 million patients across the system, performing more than 202,000 surgeries and conducting more than 476,000 emergency department visits. Patients come to Cleveland Clinic from all 50 states and more than 130 nations around the world. Cleveland Clinic is an integrated healthcare delivery system with local, national, and international reach. The main campus in midtown Cleveland, Ohio, has a 1,440-bed hospital, outpatient clinic, specialty institutes, labs, classrooms, and research facilities in 44 buildings on 167 acres. Cleveland Clinic patients represent the highest CMS case-mix index in the nation. Cleveland Clinic encompasses 75 northern Ohio outpatient locations, including 16 full-service family health centers, eight community hospitals, an affiliate hospital, and a rehabilitation hospital for children. Cleveland Clinic also includes Cleveland Clinic Florida; Cleveland Clinic Nevada, which includes the Lou Ruvo Center for Brain Health in Las Vegas, and urology and nephrology services; Cleveland Clinic Canada; and Sheikh Khalifa Medical City (management contract). Cleveland Clinic Abu Dhabi is a full-service hospital and outpatient center in the United Arab Emirates (UAE) scheduled to begin offering services in the spring of 2015. Cleveland Clinic is the second-largest employer in Ohio, with more than 43,400 employees. It generates $10.95 billion of economic activity a year. Cleveland Clinic Global Solutions supports physician education, training and consulting, and patient services around the world through offices in Riyadh, Saudi Arabia; London, England; Istanbul, Turkey; and Dubai, UAE, as well as El Salvador, Panama, Guatemala, Honduras, the Dominican Republic, and other Caribbean nations.

The Cleveland Clinic Model

Cleveland Clinic was founded in 1921 by four physicians who had served in World War I and hoped to replicate the organizational efficiency of military medicine. The organization has grown through the years by adhering to the model set forth by the founders. All Cleveland Clinic staff physicians receive a straight salary with no bonuses or other financial incentives. The hospital and physicians share a financial interest in controlling costs, and profits are reinvested in research and education. The Cleveland Clinic system began to grow in 1987 with the founding of Cleveland Clinic Florida and expanded in the 1990s with the development of 16 family health centers across Northeast Ohio. Fairview Hospital, Hillcrest Hospital, and six other community hospitals joined Cleveland Clinic over the past decade and a half, offering Cleveland Clinic institute services in heart and neurological care, physical rehabilitation, and more. Clinical and support services were reorganized into 27 patient-centered institutes beginning in 2007. Institutes combine medical and surgical specialists around specific diseases or body systems under single leadership and in a shared location to provide optimal team care for every patient. Institutes work with the Office of Patient Experience to give every patient the best outcome and experience.

Outcomes 2013166

About Cleveland Clinic

92235_CCFBCH_Rev0_1-170.pdf 166 7/29/14 8:34 AM

Cleveland Clinic Lerner Research Institute At the Lerner Research Institute, hundreds of principal investigators, project scientists, research associates, and postdoctoral fellows are involved in laboratory-based translational and clinical research. Total research expenditures from external and internal sources exceeded $248 million in 2013. Research programs include cardiovascular, oncology, neurology, musculoskeletal, allergy and immunology, ophthalmology, metabolism, and infectious diseases.

Cleveland Clinic Lerner College of Medicine Lerner College of Medicine of Case Western Reserve University is known for its small class size, unique curriculum, and full-tuition scholarships for all students. The program is open to 32 students who are preparing to be physician investigators. Cleveland Clinic is building a new Health Education Campus as the new home for the college and for its partner Case Western Reserve University’s schools of medicine, dental medicine, and nursing.

Graduate Medical Education In 2013, nearly 1,800 residents and fellows trained at Cleveland Clinic and Cleveland Clinic Florida, which is part of a continuing upward trend.

U.S. News & World Report Ranking Cleveland Clinic is consistently ranked among the top hospitals in America by U.S. News & World Report, and its heart and heart surgery program has been ranked No. 1 in the nation since 1995. In 2013, five programs were ranked No. 2 in the nation—diabetes and endocrinology, gastroenterology and GI surgery, nephrology, rheumatology, and urology.

For more information about Cleveland Clinic, please visit clevelandclinic.org.


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Referring Physician Center and Hotline

For the 24/7 hotline to streamline access to an array of medical services and schedule patient appointments, call 855.REFER.123 (855.733.3712), email [email protected], or visit clevelandclinic.org/refer123. A free Physician Referral App is now available so you can get in touch immediately with one click of your iPhone®, iPad®, or Android™ phone or tablet.

Remote Consults

Online medical second opinions from Cleveland Clinic’s MyConsult® are particularly valuable for patients who wish to avoid the time and expense of travel. Cleveland Clinic offers online medical second opinions for more than 1,200 life-threatening and life-altering diagnoses. For more information, visit clevelandclinic.org/myconsult, email [email protected], or call 800.223.2273, ext. 43223.

Request Medical Records

216.444.2640 or 800.223.2273, ext. 42640

Track Your Patients’ Care Online

DrConnect® offers referring physicians secure access to their patients’ treatment progress while at Cleveland Clinic. To establish a DrConnect account, visit clevelandclinic.org/drconnect or email [email protected]. MyPractice Community gives referring physicians online access to their patients’ test results, medications, and treatment plans during Cleveland Clinic care. Cleveland Clinic’s eRadiology system offers teleradiology consultation for physicians nationwide.

Medical Records Online

Cleveland Clinic continues to expand and improve electronic medical records (EMRs) to provide faster, more efficient, and more accurate care by sharing patient data through a highly secure network. Patients using MyChart® can renew prescriptions and review test results and medications from their personal computers. MyChart provides a link to Microsoft HealthVault, a free online service that helps patients securely gather and store health information. It connects to Cleveland Clinic’s social media and Internet site, currently the most visited hospital website in America. For more information, visit clevelandclinic.org/mychart.

Critical Care Transport Worldwide

Cleveland Clinic’s critical care transport team and fleet of mobile ICU vehicles, helicopters, and fixed-wing aircraft serve critically ill and highly complex patients across the globe. To arrange a transfer for STEMI (ST elevation myocardial infarction), acute stroke, ICH (intracerebral hemorrhage), SAH (subarachnoid hemorrhage), or aortic syndrome, call 877.379.CODE (2633). For all other critical care transfers, call 216.444.8302 or 800.553.5056.

CME Opportunities: Live and Online

Cleveland Clinic’s Center for Continuing Education operates one of the largest and most successful CME programs in the country. The center’s website (ccfcme.org) is an educational resource for healthcare providers and the public. Available 24/7, it houses programs that cover topics in 30 areas. Among other resources, the website contains a virtual textbook of medicine (Disease Management Project) and myCME, a system for physicians to manage their CME portfolios. Live courses, however, remain the backbone of the center’s CME operation. Most live courses are held in Cleveland, but outreach plans are underway.

Outcomes 2013168

Resources

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Clinical Trials

Cleveland Clinic has promoted research from its earliest days, and has since participated in historic, large, multicenter clinical trials. Today, Cleveland Clinic is running more than 2,200 clinical trials of various types. Researchers are focused on an array of conditions, including breast and liver cancer, coronary artery disease, heart failure, epilepsy, Parkinson disease, chronic obstructive pulmonary disease, asthma, high blood pressure, diabetes, depression, and eating disorders. To learn more, go to clevelandclinic.org/research.

Cancer Clinical Trials is a new mobile app that provides up-to-date information on the more than 100 active clinical trials available for cancer patients. Download the free Cancer Clinical Trials App at clevelandclinic.org/cancertrialapp.

Healthcare Executive Education

Cleveland Clinic’s executive education program offers its programs to caregivers worldwide seeking insights into the business, operations, and logistics of a major medical center. The Executive Visitors’ Program is an intensive three-day behind-the-scenes view of Cleveland Clinic’s organization for the busy executive. The Samson Global Leadership Academy is a two-week immersion into the challenges of leadership, management, and innovation. The curriculum includes coaching and a personalized three-year leadership development plan. Learn more at clevelandclinic.org/execed.


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Notes

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This project would not have been possible without the commitment and expertise of a team led by Dympna Kelly, MD; Laura Buccini, DrPH, MPH; and Charmaine Jones, MBA.

Graphic design and photography were provided by Cleveland Clinic’s Center for Medical Art and Photography.

© The Cleveland Clinic Foundation 2014

Measuring Outcomes Promotes Quality Improvement


9500 Euclid Avenue, Cleveland, OH 44195 clevelandclinic.org

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2013 Outcomes


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