TRANSPLANTATION | 2010 - Cleveland Clinic

TRANSPLANTATION | 2010

In honor of organ, tissue,

bone marrow and eye

donors and their family

members, THANK YOU

for making the gift of life

possible for our patients.

ON The cOveR: Cristiano Quintini, MD.Dr. Quintini and his team performed the first combined kidney and intestine transplant in Ohio in October 2010. The procedure lasted more than 10 hours and the patient has recovered well.

Photographer: Al Fuchs

clevelandclinic.org/transplant

2 Letter from the Chairman

3 Cleveland Clinic Transplant Center

12 The Organ Transplant Process

14 Allogen Laboratories

20 Infectious Disease

26 Bone Marrow Transplantation

32 Cardiac Transplantation

40 Corneal Transplantation

44 Intestinal Transplantation

50 Liver Transplantation

58 Lung and Heart/Lung Transplantation

66 Pancreas and Kidney/Pancreas Transplantation

72 Renal Transplantation

80 Tissue Transplantation

87 Support Staff

88 Donation and Procurement Agencies

90 About Cleveland Clinic

TABLe Of COnTenTS


I am pleased to share highlights of the Cleveland Clinic Transplant Center for 2010.

Our staff values the opportunity to work with you and keep you abreast of our

transplant efforts.

Innovation In October 2010, we performed our first intestine/kidney transplant —

the first of its kind in Ohio. Cleveland Clinic transplant surgeons Cristiano Quintini,

MD; Koji Hashimoto, MD; federico Aucejo, MD; and Venkatesh Krishnamurthi, MD,

performed the landmark procedure during a single operation that lasted more than

10 hours. The patient, featured on page 44, has recovered well, is off dialysis and is

eating normally for the first time in years.

On Dec. 15, 2010, the Cleveland Clinic Intestinal Rehabilitation and Transplant

Program (IRTP) received CMS certification. Currently, 46 intestinal transplant

programs are active in the United States, and only 15 are CMS-certified. Cleveland

Clinic’s program is one of only eight certified programs specializing in the care of

adult patients.

Additionally, our other organ transplant programs were recertified by CMS in 2010.

Excellence In 2010 we completed more than 800 organ, tissue and bone

marrow transplants and are proud to offer patients one of the most comprehensive

transplant programs in the world. Our physicians continue to achieve outstanding

outcomes while performing complex transplant procedures involving multiple

organs and the most critically ill patients. Additionally, our physicians work to

maximize the use of all available donor organs, including those considered to be

from extended criteria donors.

Compassion Most of all, we celebrate our patients. Their stories, featured

throughout this book, inspire us to continue to refine our care and delve more deeply

into research that enables us to provide optimal outcomes. All of us at the Cleveland

Clinic Transplant Center are grateful for the opportunity to help our patients lead

active lives unencumbered by organ failure.

LeTTeR fROM THe CHAIRMAn

John Fung, MD, PhDDirector, Transplant Center; Chairman, Digestive Disease Institute

clevelandclinic.org/transplant02 | 03

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Transplantation Outcomes

We are pleased to present Transplantation 2010, a summary of outcomes and key data about Cleveland Clinic Transplant Center programs. The following data summarize our activities for the year.

Number of evaluations in 2010

Transplant Type number of Patients

Bone marrow 325

Heart 238

Intestine 105

Kidney 483

Liver 477

Lung 629

Pancreas 35


* (includes 5 heart/lung)

** (includes 2 intestine/pancreas/liver and 1 intestine/kidney)

*** (includes 12 kidney/pancreas, 10 kidney/liver and 1 kidney/intestine)

**** (includes 10 liver/kidney and 2 liver/intestine/pancreas)

***** (includes 5 lung/heart)

****** (includes 12 pancreas/kidney and 2 pancreas/intestine/liver)

Number of solid organ transplants in 2010

Organ number of Transplants

Heart 52 *

Intestine 10 **

Kidney 159 ***

Liver 133 ****

Lung 122 *****

Pancreas 22 ******

† As of Dec. 31, 2010.

* (includes 5 heart/kidney and 3 heart/lung and 2 heart/liver)

** (includes 1 intestine/pancreas)

*** (includes 26 kidney/pancreas, 10 kidney/liver and 5 kidney/heart)

**** (includes 10 liver/kidney, 2 liver/heart and 2 liver/lung)

***** (includes 3 lung/heart and 2 lung/liver)

****** (includes 26 pancreas/kidney and 1 pancreas/intestine)

Number of patients on waiting lists†

Organ number of Patients Waiting

Heart 118 *

Intestine 4 **

Kidney 713 ***

Liver 213 ****

Lung 141 *****

Pancreas 47 ******

Number of solid organ transplants in 2010

Organ number of Transplants

Heart 52 *

Intestine 10 **

Kidney 159 ***

Liver 133 ****

Lung 122 *****

Pancreas 22 ******


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* (includes 16 heart/lung, 4 heart/liver and 2 heart/kidney)

** (includes 2 intestine/pancreas/liver, 1 intestine/kidney and 1 intestine/pancreas)

*** (includes 115 kidney/pancreas, 39 kidney/liver, 2 kidney/heart and 1 kidney/intestine)

**** (includes 39 liver/kidney, 4 liver/heart, 4 liver/pancreas, 3 liver/lung and

2 liver/intestine/pancreas)

***** (includes 16 lung/heart and 3 lung/liver)

****** (includes 115 pancreas/kidney, 4 pancreas/liver, 2 pancreas/intestine/liver and

1 pancreas/intestine)

Number of post-transplant patients seen at Cleveland Clinic during 2010

Organ number of Patients

Heart 762 *

Intestine 14 **

Kidney 1,426 ***

Liver 954 ****

Lung 535 *****

Pancreas 189 ******

Median time (months) to transplant for waitlisted patients*

Organ Cleveland Clinic U.S. (average)

Heart

Heart/Lung

Intestine

Kidney

Kidney/Pancreas

Liver

Lung

Pancreas

* Patients registered on the waitlist between July 1, 2004, and Dec. 31, 2009.

(Source: Scientific Registry of Transplant Recipients, January 2011.)

3.1

4.5

11.6

41.3

14.3

6.3

2.7

14.9

4.9

>72.0

6.1

48.2

13.7

10.8

5.6

19.5

State of residence of transplant patients in 2010 St

ate

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Total

1

1

3

1

1

1

139

8

5

1

161

1

1

2

4

28

2

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1

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3

3

47

1

3

1

5

7

7

State of residence of transplanted patients 2010


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Inte

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e/K

idne

y

Inte

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ver/

Panc

reas

Kid

ney

Kid

ney/

Live

r

Kid

ney/

Panc

reas

Live

r

Lung

Panc

reas

Tota

l

1

1

2

2

1

2

1

1

1

117

4

1

7

1

136

1

1

2

5

1

10

1

2

7

1

1

12

1

1

1

2

1

1

4

1

1

8

86

7

2

5

121

1

1

1

1

1

1

3

3

1

1

13

1

2

1

21

55

3

2

1

1

2

1

117

6

1

1

8

2

1

2

4

1

3

1

1

1

8

8

1

2

2

20

1

2

3

1

1

38

454

28

2

1

5

1

1

1

24

7

627


1963

• Developed one of the first deceased-donor kidney transplant programs in the world

• first kidney transplant (January)

• first pediatric kidney transplant (April)

1968

• Allogen Laboratories established

• first heart transplant

1975

• Bone marrow transplant program established

1984

• Heart transplant program established (August)

• first liver transplant (november)

1985

• first pediatric heart transplant (March)

• first kidney/pancreas transplant (October)

1986

• first pediatric liver transplant (August)

1988

• World’s first successful laryngeal transplant (January)

• first pancreas transplant (March)

1990

• first lung transplant (february)

Cleveland Clinic Transplant Center history


1998

• fresh Osteochondral Graft Transplant Program established

2001

• first sacral bone transplant performed by neurospine surgeons

• first mosaicplasty performed by orthopaedic adult reconstruction and sports medicine surgeons

2005

• first hospital in America to implant the CardioWest Total Artificial Heart after its approval by the fDA

2007

• Heart, liver, lung and pancreas programs named as Best Practices in preparation for a Health Resources and Services Organization (HRSA) Transplant Center Growth and Manage-ment Collaborative

• first lung-liver transplant in Ohio (January)

• first double lung transplant with bronchial artery revascularization (December)

2008

• first intestinal transplant (June)

• Most complex facial transplant in the world (December)

2009

• new world record for lung transplant volume in a single year

2010

• Transplanted third patient in Ohio with eXCOR Pediatric Heart Implant

• first adult kidney-intestine transplant in Ohio (October)

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Cleveland Clinic Children’s hospital

Cleveland Clinic offers the full spectrum of pediatric transplants — cornea, bone/tissue, bone marrow/stem cell, heart, lung, liver, kidney and intestinal — along with more than 300 pediatric specialists with round-the-clock availability.

Transplantation facilities

Pre-Transplant Heart failure Intensive Care Unit, 10 beds

Surgical Intensive Care Unit, 38 beds

Heart/Lung Post-Transplant Intensive Care, 14 beds

Cardiothoracic Intensive Care Unit, 76 beds

Transplant Special Care, 34 beds

Heart/Lung Transplant Unit, 24 beds

Pediatric Intensive Care Unit, 25 beds

Bone Marrow Transplant Unit, 22 beds

Pediatric Med/Surg floors, 71 beds

Transplant Hospitality Housing Unit, 37 rooms

alternatives to Transplantation

Making the decision that transplantation is the best or only option to treat an individual’s disease is a crucial phase of transplant evaluation. Transplantation is one option in an overall strategy for treating patients with advanced organ disease and some types of cancer. Before making the decision to go ahead with transplantation, physicians explore all of the choices available to the patient.

Transplantation is not always the most appropriate choice, even for people with end-stage disease. Successful transplantation depends in part on careful patient selection, and patients must meet certain medical criteria before they even can be considered for transplantation.

for more information on the Transplant Center, call 800.223.2273, ext. 42394, or 216.444.2394. Visit our website at clevelandclinic.org/transplant.


a note on outcomes in this book

Many factors influence a transplant center’s actual outcomes (survival rates). for example, some transplant centers perform transplants on much sicker patients than others do. A good measure is to look at a transplant center’s actual vs. expected rates, as “expected” survival takes into account such factors as the re-cipient’s condition and other characteristics, donor characteristics, and survival rates of all transplant patients in the United States. Cleveland Clinic’s transplant outcomes generally meet or exceed expected survival rates.

To obtain comparisons of actual vs. expected outcomes, please visit srtr.org.

Survival rates from this book are calculated by a third party, the Scientific Registry of Transplant Recipients (SRTR), and available in the January 2011 release. Survival rates are based on single-organ transplants only.

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* note: This process applies to solid organ transplantation only and may vary asnecessary according to the patient’s condition and transplant type.

THe ORGAn TRAnSPLAnT PROCeSS*

phase 1 referral and evaluation

Patients can be referred for transplant evaluations at Cleveland Clinic by calling 800.223.2273, ext. 42394, or 216.444.2394. At the time of referral, a member of the team will collect a basic history of the patient’s past medical conditions, results of any diagnostic studies performed and a description of the current clinical condition of the patient.

A transplant evaluation is scheduled, including tests and consults with a trans-plant physician and transplant surgeon, social worker, financial coordinator, nutritionist, transplant coordinator and other specialists.

Decisions regarding approval of candidates for transplantation are made by consensus, following review of each patient’s case at a selection meeting. for heart, intestinal, liver, lung and pancreas transplants, the final step in the review process includes approval by the Ohio Solid Organ Transplant Consortium. for heart, intestinal, liver, lung, kidney and pancreas transplants, the final step after the evaluation process is complete is notification of the patient, referring physi-cian and insurance carrier regarding the decision about transplantation.

phase 2 Ongoing Medical Therapy review

for those individuals not approved for transplantation, continuing medical therapy by a specialist is available.

The medical transplant team manages those patients approved for transplanta-tion. Solid organ transplant patients are placed on the national transplant wait-ing list. Kidney and liver transplant patients may be considered for living donor transplantation.

phase 3 Transplantation

When an organ is available for transplantation, the patient is notified by one of the transplant coordinators. The patient then reports to the hospital and is admitted to the transplant floor. following transplantation, patients may be


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transferred to an intensive care unit, where their care is jointly managed by the transplant team and staff of the intensive care unit. The team assumes primary care at the time of transplant and during the hospital stay in the Transplant Special Care Unit and provides long-term follow-up.

phase 4 follow-up

following discharge, the patient’s progress is monitored during regular out-patient visits with the transplant team. All transplant patients return to the transplant clinic on a schedule as needed, when the medications are reviewed and adjusted as necessary. Additional appointments and diagnostic studies are scheduled as needed. All patients are asked to return to Cleveland Clinic annually for follow-up. We communicate regularly with the patients’ referring physicians throughout all phases of care.

for some patients outside the Greater Cleveland area, arrangements can be made with a local physician for routine follow-up after a period of time. In this case, members of the transplant team will establish contact with the physician to continue to monitor the patient’s progress.

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leadership

Medhat z. askar, MD, phD Director, Allogen Laboratories

2010 highlights

In 2010, technologists at Cleveland Clinic’s Allogen Laboratories performed 80,759 tests on transplant patients and potential donors to determine compat-ibility. These included tests to determine whether the patient and donor had compatible blood and tissue types, as well as whether antibodies that could cause rejection were present in the patient’s blood.

Blood test results are entered into a computer at the United network for Organ Sharing (UnOS), which assists physicians in determining whether the patient is an appropriate candidate when an organ becomes available. (for more information on UnOS and the evaluation/waiting process, visit unos.org.)

New in 2010:

Aiwen Zhang, PhD, was promoted to Postdoctoral Research fellow/Director-in-Training, and Garnett Smith, MD, a third-year Cleveland Clinic Lerner College of Medicine medical student, began a one-year research rotation.

Initial meetings were held to determine the need and feasibility of a separate lab for nontransplant testing to service Cleveland Clinic studies and clinical refer-ence labs handled as Pathology & Laboratory Medicine Institute send-outs.

Medhat Z. Askar, MD, was awarded a scholarship opportunity in the Harvard Macy Program for educators in the Health Professions through the Harvard Macy Institute of the Harvard Medical School during the periods of January 9-19 and May 15-20, 2011.

In 2010, Allogen Laboratories of Cleveland passed the following inspections:

• ASHI Interim/Self-Inspection

• Cellerant Protocol MT2008-38 Inspection

• Lifebanc Annual Inspection

• Cleveland Clinic Health System Pharmacy Inspection

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ALLOGen LABORATORIeS

John fung, MD, phD Medical Director, Allogen Laboratories


And Allogen Laboratories-WV of Charleston, W.Va., passed the following inspec-tion:

• ASHI Interim/Self-Inspection

Additionally, Allogen Laboratories-WV moved to a new space that is 626 square feet larger than its previous space (a 65 percent increase).

awards and achievements

Medhat Askar, MD, won Best Abstract Award for “Killer Immunoglobulin-like Receptors (KIR) Genotype but not Haplotype Have Profound Impact on Primary CMV Infection and CMV Related Mortality in the D+/R- Solid Organ Transplant Recipient” presented at the Annual Meeting of the British Society for Histocom-patibility and Immunogenetics, Sept. 29 to Oct. 1, 2010, edinburgh, U.K.

Additionally, Dr. Askar received the Cleveland Clinic Medical education fellow-ship Award for September 2010 to August 2011.

Allogen Labs was noted eight times for recognizing unusual characteristics of human leukocyte antigen (HLA) antigens/alleles in the 2010 publications of the UCLA International Cell exchange.

research and innovations

Current IRB-approved studies include:

Principal Investigators – Dr. Diane Pidwell and Dr. Medhat AskarIRB 09-591 Allogen Registry/Database was approved for the purpose of utilizing stored laboratory specimens and/or test results for internal clinical research, case studies, assay evaluation, assay validation and clinical research, often in conjunction with other Cleveland Clinic departments.

Principal Investigator – Dr. Diane PidwellIRB 1213: Histocompatibility Lab Reagent Program.

Principal Investigator – Dr. Medhat AskarIRB 09-979: Chart Review: Clinical Outcomes of Combined Liver Transplants.

Principal Investigators – Dr. Johnathan Taliercio and Dr. Peter LalliIRB 09-977: Chart Review: efficacy of Plasmapheresis in Acute Humoral Kidney Rejection.

fast facts

Initiated: 1968

number of tests performed in 2010:

80,633

Special accreditations

Centers for Medicare & Medicaid Services (CMS)-certified laboratory

fully accredited by the United network for Organ Sharing (UnOS) and the American Society for Histocompatibility and Immunogenetics (ASHI)


New IRBs and Research for 2010:

Principal Investigator – Dr. Medhat Askar Cellerant Therapeutics, Inc. Protocol MT2008-38: A Phase I Trial to Determine Safety and Tolerability of Ex Vivo expanded Human Myeloid Progenitor Cells (CLT-008) Infused 24 Hours Post-Transplant to Support Allogeneic Umbilical Cord Blood Transplantation for Hematologic Malignancies.

Principal Investigator – Dr. Medhat AskarIRB 10-042: Chart Review: HLA Antibody Kinetics following Pre-Transplant Vaccination in Solid Organ Transplant Recipients.

Principal Investigator – Dr. Medhat AskarIRB 10-047: Chart Review: The Incidence and Significance of Positive Historic Donor HLA Specific Antibodies (DSA) in Lung Transplantation.

Principal Investigator – Dr. Medhat AskarIRB 10-1045: Chart Review: The Clinical Relevance of Positive/negative Current Donor HLA Specific Antibodies (DSA) in Kidney and Kidney/Pancreas Transplantation.

Principal Investigator – Dr. Medhat AskarIRB 10-1151: Registry: Adiponectin Bridges Metabolic and Immunologic Mechanisms in Cardiac Allograft Vasculopathy.

Principal Investigators – Dr. Robin Avery and Dr. Medhat AskarIRB 10-435: exempt: eBV DnA Viral Loads, BOS/CLAD, and neutropenia in Lung Transplant Recipients with Greater than 5 Years of follow-up.

Principal Investigators – Dr. Lara Danziger-Isakov and Dr. Medhat AskarIRB 10-471: Chart Review: Toll-like Receptor Polymorphisms: Association with RSV Severity and Graft Outcomes in Adult Lung-Transplant Patients.

Principal Investigators – Dr. Garnett Smith and Dr. Medhat AskarIRB 10-597: Chart Review: The Role of non-HLA Antibodies in Human Lung Transplantation.

Principal Investigator – Dr. Medhat AskarIRB 10-637: Chart Review: The Impact of HLA Antibodies on Liver Transplant Outcomes.

Principal Investigator – Dr. Medhat AskarIRB 10-778: Chart Review: Possible Role of Human Leukocyte Antigens (HLA) in the Susceptibility to Serious Drug Adverse Reactions: A Study in Transplant Recipients.

phone number216.444.6583

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Principal Investigators – Dr. Maria Siemionow and Dr. Medhat AskarIRB 6914: Protocol for Composite facial Allograft Transplant.

Principal Investigator – Dr. Peter LalliIRB 010-283: Chart Review: IgM Interference in Luminex Single Antigen Bead Analysis.

Principal Investigators – Dr. Emilio Poggio and Dr. Peter LalliIRB 010-855: effects of Bortezomib (Velcade) on T Cell Alloreactivity.

Principal Investigators – Dr. Shih-Chieh Jeff Chueh and Dr. Medhat AskarCharleston Area Medical Center, Charleston, W.Va.IRB 10-07-2247: Allogen Laboratories-WV Reagent Blood Donor Program.

Principal Investigators – Dr. Shih-Chieh Jeff Chueh and Dr. Medhat AskarCharleston Area Medical Center, Charleston, W.Va.IRB 10-07-2248: Allogen Laboratories-WV Cylex® ImmuKnow® Assay Validation.

expertise

Allogen Laboratories was one of the first tissue typing laboratories in the country and remains one of the largest in the United States today. It continues to develop, investigate and apply state-of-the-art histocompatibility techniques to support transplant centers nationwide. Three of our employees performed a total of 10 lab inspections for ASHI.

Selected publications

Askar M. Monitoring Aspects of face Transplantation: Immunological Monitoring. In: The Know How of Face Transplantation. ed: Maria Siemionow, Anticipated Date of Publica-tion: March 2011. Publisher: Springer-Verlag, London Ltd.

Askar M, Avery R, Hemachandra S, Zhang A, Thomas D, van Duin D. Killer immunoglobulin-like receptors (KIR) genotype but not haplotype have profound impact on primary cmv infection and cmv related mortality in the D+/R- solid organ transplant recipient. Int J Immunogenet. 2010;37(6):418.

Lalli PN, Klingman LL, Pidwell DJ. HLA-Specific IgM can prevent post-transplant detection of donor-specific IgG. Human Immunol. 2010;71(s1):S63.

Lalli PN, Klingman LL, Flechner SM, and Pidwell DJ. Masking of donor-specific IgG antibody by HLA- specific IgM. Am J Transplant. 2010;10(s4):422.

Pidwell, DJ, Lalli Pn. The Histocompatibility Laboratory in Clinical Transplantation. In: Kidney and Pancreas Transplantation: A Practical Guide. eds: Srinivas TR and Shoskes DA. new York, nY: 2010. p. 23-48.


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Sobecks R, Copelan E, Kalaycio M, Askar M, Rybicki L, Serafino S, Serafin M, Macklis R, Dean R, Pohlman B, Andresen S, Bolwell B. Multiple unit umbilical cord blood transplantation with total body irradiation, etoposide and antithymocyte globulin for adult hematologic malignancy patients. Br J Haematol. 2011;152(1):116-9.

Srinivas T, flechner S, Poggio e, Askar M, Goldfarb D, navaneethan S, Schold J. GfR slopes have significantly improved among renal transplants in the U.S. Transplantation. 2010;90(12):1499-505.

flechner S, fatica R, Askar M, Stephany B, Poggio e, Koo A, Banning S, Chiesa-Vottero A, Srinivas T. The role of proteasome inhibition with bortezomib in the treatment of antibody mediated rejection after kidney-only or kidney-combined organ transplantation. Transplantation. 2010;90(12):1486-92.

flechner M, Berber e, Askar M, Stephany B, Agarwal A, Milas M. Allotransplantation of cryopreserved parathyroid tissue for severe hypocalcemia in a renal transplant recipient. Am J Transplant. 2010;10(9):2061-5.

Viny AD, Clemente MJ, Jasek M, Askar M, Ishwaran H, nowacki A, Zhang A, Maciejewski JP. MICA polymorphism identified by whole genome array associated with NKG2D-mediated cytotoxicity in T-cell large granular lymphocyte leukemia. Haematologica. 2010;95(10):1713-21.



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Close collaboration with infectious disease (ID) physicians who have expertise in post-transplant infections is essential to the success of any transplant program. This is primarily because many types of infections are common after transplan-tation due to the effects of immunosuppressive medications administered to prevent rejection.

2010 highlights

Adoption of the transplant ID education curriculum created by several members of our section by the AST ID COP:

Avery R, Clauss H, Danziger-Isakov L, Davis J, Doucette K, van Duin D, fish-man J, Gunseren f, Humar A, Husain S, Isada C, Julian K, Kaul D, Kumar D, Martin S, Michaels M, Morris M, Silveira f, Subramanian A.

Recommended curriculum for subspecialty training in transplant infectious disease on behalf of the American Society of Transplantation Infectious Diseases Community of Practice educational Initiatives Working Group. Transplant Infectious Disease. 2010;12(3):190-4.

expertise

Cleveland Clinic’s Department of Infectious Disease consists of 24 staff physi-cians, 14 of whom round on the transplant infectious disease hospital services. The Section of Transplant Infectious Disease was established to provide expert support and excellent clinical care and consultation for the transplant teams. It includes 10 adult physicians, one pediatric physician and one nurse practitioner who rotate and perform inpatient and outpatient consultations on solid organ transplantation and bone marrow transplant services.

Section Head Sherif Mossad, MD, specializes in bone marrow transplantation and respiratory viruses, including influenza. Steven Mawhorter, MD, is an expert in immunology, parasitic infections and travel medicine. David van Duin, MD, has expertise in immunology, aging and donor/recipient screening for infection before transplantation. new to the staff in 2010, eric Cober, MD, specializes

InfeCTIOUS DISeASe leadership

Steven gordon, MD Chairman, Department of Infectious Disease

Sherif Mossad, MD Section Head, Transplant Infectious Disease

lara Danziger-isakov, MD, Mph Leader, Pediatric Transplant Infectious Disease

20 | 21


in cytomegalovirus and fungal infections in hematopoietic stem cell transplant recipients and Christine Koval, MD, specializes in markers of infection in liver and kidney transplant recipients.

nabin Shrestha, MD, is an authority on new molecular diagnostic tests for infections.

Robin Avery, MD, was a co-editor of the infectious disease guidelines for the American Society of Transplantation (AST) and is a past Chair of the AST ID Community of Practice, a group of more than 75 clinicians involved in transplant infectious disease. Her research involves viral and fungal infections after trans-plant and the effects of infections on transplant function. Lara Danziger-Isakov, MD, MPH, is a member of the executive Committee of the AST’s ID Community.

Dr. Avery and Dr. Danziger-Isakov are members of several international guide-lines committees. Steven Gordon, MD, and Drs. Avery, Mawhorter, and Mossad are fellows of the Infectious Diseases Society of America. Under the leadership of Alan Taege, MD, the HIV section provides clinical consultation and advice on transplantation for HIV-positive recipients.

The transplant ID group also provides rapid outpatient access for transplant recipients with symptoms of infection and for transplant candidates who require evaluation for previous infections that could have an impact after transplant.

for pre-transplant patients, every effort is made to treat past infections, update vaccinations and devise individualized programs for infection prevention after transplantation.

The transplant ID group advises all transplant teams on regimens for preventing infection after transplantation. This preventive approach involves close monitor-ing for viral infections with the goal of early treatment, if needed. It also helps to decrease hospitalizations and illnesses after transplant. Members of the transplant ID group also participate in patient education with the philosophy that better understanding of infectious risks can help transplant recipients avoid infections.


Medhat Askar, MD, won Best Abstract Award for “Killer Immunoglobulin-like Receptors (KIR) Genotype but not Haplotype Have Profound Impact on Primary CMV Infection and CMV Related Mortality in the D+/R- Solid Organ Transplant Recipient” presented at the Annual Meeting of the British Society for Histocom-patibility and Immunogenetics, Sept. 29 to Oct. 1, 2010, edinburgh, U.K.


research

Principal Investigator – Dr. Lara Danziger-IsakovInfluenza vaccination and allosensitization in lung transplant candidates.

Principal Investigator – Dr. Lara Danziger-IsakovValidation of ISHLT society definitions of respiratory infections in lung transplant recipients.

Principal Investigators – Dr. Robin Avery and Dr. Sherif MossadInfluenza in SOT and HSCT recipients: 2 studies; duration of shedding and dose-varying treatment with oseltamivir.

Principal Investigator – Dr. Sherif MossadVaricella zoster subunit vaccine study in autologous HSCT recipients.

Principal Investigator – Dr. Sherif MossadCMV prevention and early treatment with CMX001; a novel lipid formulation of cidofovir.


Avery RK. Low-dose valganciclovir for cytomegalovirus prophylaxis in organ transplanta-tion: Is less really more? Clinical Infectious Diseases. 2010; doi: 10.1093/cid/ciq145. Published online Dec. 28, 2010.

Avery RK. Infectious disease following kidney transplant: core curriculum 2010. Am J Kidney Dis. 2010; Apr 55(4):755-71.

Palmer SM, Limaye AP, Banks M, Gallup D, Chapman J, Lawrence eC, Dunitz J, Milstone A, Reynolds J, Yung GL, Chan KM, Aris R, Garrity e, Valentine V, McCall J, Chow SC, Davis RD, Avery R. extended valganciclovir prophylaxis to prevent cytomegalovirus after lung transplantation: a randomized, controlled trial. Ann Intern Med. 2010 June 15; 152(12):761-9.

Cuellar-Rodriguez J, Avery RK, Lard M, Budev M, Gordon SM, Shrestha nK, van Duin D, Mawhorter SD. Reply to Hage et al. (Letter) Clin Infect Dis. 2010 Jan 1;50(1):123-4.

Kumar D, Michaels MG, Morris MI, Green M, Avery RK, Liu C, Danziger-Isakov L, Stosor V, estabrook M, Gantt S, Marr KA, Martin S, Silveira fP, Razonable RR, Allen UD, Levi Me, Lyon GM, Bell Le, Huprikar S, Patel G, Gregg KS, Pursell K, Helmersen Julian KG, Shiley K, Bono B, Dharnidharka VR, Alavi G, Kalpoe JS, Shoham S, Reid Ge, Humar A. Outcomes from pandemic influenza A H1N1 infection in recipients of solid-organ trans-plants: a multicentre cohort study. Lancet Infect Dis. 2010 Aug;(8):521-6.

Avery R, Clauss H, Danziger-Isakov L, Davis J, Doucette K, van Duin D, fishman J, Gunseren f, Humar A, Husain S, Isada C, Julian K, Kaul D, Kumar D, Martin S, Michaels M, Morris M, Silveira f, Subramanian A. Recommended curriculum for subspecialty training in transplant infectious disease on behalf of the American Society

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of Transplantation Infectious Diseases Community of Practice educational Initiatives Working Group. Transpl Infect Dis. 2010 June;12(3):190-4.

Avery RK, Mossad SB, Poggio e, Lard M, Budev M, Bolwell B, Waldman WJ, Braun W, Mawhorter SD, fatica R, Krishnamurthi V, Young JB, Shrestha R, Stephany B, Lurain N, Yen-Lieberman B. Utility of leflunomide in the treatment of complex cytomegalovirus syndromes. Transplantation. 2010 Aug 27;90(4):419-26.

Askar M, Avery R, Hemachandra S, Zhang A, Thomas D, van Duin D. Killer immuno-globulin-like receptors (KIR) genotype but not haplotype have profound impact on primary CMV infection and CMV related mortality in the D+/R- solid organ transplant recipient. Int J Immunogenet. 2010;37(6):418.

Mossad SB. Antimicrobial prophylaxis regimen for allogeneic and autologous HSCT recipients. The AST Handbook of Transplant Infections. edited by Marr K, Michaels M, Blumberg e, Kumar D, Humar A. Publisher: John Wiley & Sons. 2010; in press.

Danziger-Isakov LA, Cherkassky L, Siegel H, McManamon M, Kramer K, Budev M, Sawinski D, Augustine JJ, Hricik De, fairchild R, Heeger PS, Poggio eD. effects of influenza immunization on humoral and cellular alloreactivity in humans. Transplantation. 2010 Apr;15;89(7):838-44.

Staff

Robin Avery, MD

eric Cober, MD

Lara Danziger-Isakov, MD

Jorgelina DeSanctis, MD

Thomas fraser, MD

Lucileia Teixeira Johnson, MD

Christine Koval, MD

Steven Mawhorter, MD

Cyndee Miranda, MD

nabin Shrestha, MD

Rabin Shrestha, MD

Alan Taege, MD

David van Duin, MD, PhD


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JOSeTTe MargiOTTi | BONe MarrOw TraNSplaNT reCipieNT

“The team at Cleveland Clinic was wonderful. That’s the upside to an overwhelming experience,

and I really feel blessed.” — Josette Margiotti, 58, Westlake, Ohio. Despite meeting none of the risk

factors and with fatigue as her only symptom, Josette was diagnosed with multiple myeloma in 2004.

After her myeloma cells increased, her doctor advised her to undergo transplant. Josette donated her

own bone marrow and underwent transplant last year. She is thrilled be back outside in her garden.


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leadership

Brian Bolwell, MDInterim Chair, Taussig Cancer Institute; Chairman, Department of Hematologic Oncology and Blood Disorders; Vice Chairman, Office of the Chief of Staff; Professor of Medicine, Cleveland Clinic Lerner School of Medicine of Case Western Reserve University

BOne MARROW TRAnSPLAnTATIOn

2010 highlights

The Bone Marrow Transplant (BMT) Program team performed 161 bone marrow/stem cell/umbilical cord blood transplants in 2010. We performed 44 autologous transplants for non-Hodgkin lymphoma and 41 for multiple myeloma amyloidosis.

The most common disease indication for transplantation was non-Hodgkin lymphoma. This was followed by myeloma/amyloidosis, acute leukemias and Hodgkin lymphoma.

Our 100-day survival rate for autologous transplantation was 99 percent. Our 100-day survival rate for related ablative allogeneic transplantation was 92 per-cent, and for all nonmyeloablative allogeneic transplantation was 100 percent.

In 2010, we welcomed Rabi Hanna, MD, and Hien Duong, MD. Dr. Hanna is the Director of Pediatric Bone Marrow Transplantation in Cleveland Clinic Children’s Hospital Department of Pediatric Hematology and Oncology. His specialty interests include treatment of children with malignant and nonmalig-nant disorders who need hematopoietic stem cell transplantation to consolidate the treatment for their malignant disease or to restore normal hematological and immunologic function. Dr. Duong specializes in chronic leukemia, myeloprolif-erative disorders, hematopoietic stem cell transplant and stem cell mobilization.


Our program is driven by clinical and translational investigation. We delivered five oral presentations and 10 posters at the American Society of Hematology (ASH) Annual Meeting.

We also created the Central Line Associated Bloodstream Infection (CLABSI) Task force for hematology/oncology and transplant patients in 2010. The task force comprises hematology physicians and infectious disease clinicians who discuss and implement ways to make changes to improve our practice and better define CLABSI in our patient population. Our transplant population is particularly

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fast facts

Initiated: 1975

national Marrow Donor Program approval:nov. 22, 1988

As of Dec. 31, 2010, 3,635 bone marrow transplants have been performed at Cleveland Clinic.

One of four Ohio centers belonging to the national Marrow Donor Registry

Special accreditations

foundation for the Accreditation of Cellular Therapy (fACT)

Collaboration

We continue successful collaboration with the Seidman Cancer Center as part of the Case Comprehensive Cancer Center.

susceptible to CLABSI, and we want to provide clear guidelines for bedside care-givers to ensure they are in a position to succeed. Our goal is to monitor these infections, discover any trends and do all we can to prevent them.

Also in 2010, our longitudinal research findings demonstrated that a consistent lay care partner during inpatient hospitalization positively and significantly im-pacts survival among allogeneic BMT patients. The outcomes from our care partner and adjustment-to-illness studies have enabled us to design interven-tions (and research) to address the needs of BMT patients who do not have ad-equate familial/lay care partner support and who have problematic adjustment to illness (denial, resignation), with the goal of improving their medical (e.g., survival, readmission) and psychosocial outcomes (e.g., short- and long-term coping, quality of life, mood states).

Dr. Duong and Priscilla figueroa, MD, in our Progenitor Cell Processing Lab have been evaluating the recovery and viability of hematopoietic stem cells that are cryopreserved over a long period of time. We have found that stem cells cryopreserved for more than 15 years still retain quality characteristics that are important for adequate stem cell engraftment.

Recently, we began writing a clinical trial with our Music Therapy Program to study the influence of music therapy on nausea and pain in patients undergoing autologous transplant. The study will use perception scales and patient ques-tionnaires and compare the use of pain medication between patients receiving music therapy and patients who do not.


Matt Kalaycio, MD, was named to the Medical Advisory Board of the Bone Marrow foundation. He also was named Co-Chairman of the Chronic Leukemia Working Committee of the Center for International Blood and Marrow Transplant Research, which provides scientific oversight for studies related to hematopoi-etic cell transplantation for chronic leukemias and myeloproliferative disorders. Dr. Kalaycio also was named Deputy Director of Cleveland Clinic’s BMT Program in 2010.

Cleveland Clinic’s BMT Program, including Apheresis and the Progenitor Cell Processing Lab, was originally accredited in October 2002 and was reaccredited in 2010 by the foundation for the Accreditation of Cellular Therapy (fACT). Ronald Sobecks, MD, the program’s Quality Review Officer, is a certified fACT inspector and works with Sheila Serafino, MT(ASCP), MBA, the program’s Quality Manager, to maintain our accreditation.



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Number of transplants in 2010*

number Percent

Autologous 99 61.5

Allogeneic 41 25.5

Reduced intensity and nonmyeloablative 21 13.0

Total 161

* Data accurate as of Jan. 20, 2011.

length of stay from admission to discharge for patients transplanted in 2010*

Mean Median number

All 26 21 138

Autologous 20 20 93

Allogeneic (related donor) 26 23 14

Allogeneic (unrelated donor) 45 39 31

* excluding outpatient nonmyeloablative transplants. Data accurate as of Jan. 20, 2011.

primary diagnoses for bone marrow patients transplanted in 2010*

Diagnosis number Percent

Myeloma/amyloidosis 42 26.1

non-Hodgkin lymphoma 51 31.7

AML 26 16.1

Hodgkin disease 14 8.7

Myelodysplastic syndrome 12 7.5

ALL 10 6.2

Aplastic anemia 1 0.6

CML 0 0.0

CLL 1 0.6

neuroblastoma 1 0.6

Others 3 1.9

Total 161

* Data accurate as of Jan. 20, 2011.



Shaughnessy PJ, Bolwell BJ, Van Besien K, Mistrik M, Grigg A, Dodds A, Prince HM, Durrant S, Ilhan O, Parenti D, Gallo J, foss f, Apperley J, Zhang MJ, Horowitz MM, Abhyankar S. extracorporeal photopheresis for the prevention of acute GVHD in patients undergoing standard myeloablative conditioning and allogeneic hematopoietic stem cell transplantation. Bone and Marrow Transplantation. 2010;45(6):1068-76.

Dean RM, Pohlman B, Sweetenham JW, Sobecks RM, Kalaycio Me, Smith SD, Copelan eA, Andresen S, Rybicki LA, Curtis J, Bolwell BJ. Superior survival after replacing oral with intravenous busulfan in autologous stem cell transplantation for non-Hodgkin lymphoma with busulfan, cyclophosphamide and etoposide. Br J Haematol. 2010 Jan;148(2):226-34.

Kalaycio Me, Kukreja M, Woolfrey Ae, Szer J, Cortes J, Maziarz RT, Bolwell BJ, Buser A, Copelan e, Gale RP, Gupta V, Maharaj D, Marks DI, Pavletic SZ, Horowitz MM, Arora M. Allogeneic hematopoietic cell transplant for prolymphocytic leukemia. Biol Blood Marrow Transplant. 2010 Apr;16(4):543-7.

Hill BT, Bolwell BJ, Rybicki L, Dean R, Kalaycio M, Pohlman B, Tench S, Sobecks R, Andresen S, Copelan e. nonmyeloablative second transplants are associated with lower nonrelapse mortality and superior survival than myeloablative second transplants. Biol Blood Marrow Transplant. 2010 Dec;16(12):1738-46.

Survival analysis: 100-day patient survival for primary transplants 2008-2009

100-Day Survival (%) NumberAutologous

non-Hodgkin lymphoma 89.4 85Myeloma 97.7 86Hodgkin disease 96.2 26

Allogeneic

Low risk 91.6 24Intermediate risk 68.4 19High risk 72.7 33Other* 100 16

Reduced intensity

Low risk 85.7 14Intermediate risk 100 6High risk 92.3 13Other* 80 5

* Includes diseases not assigned a risk.


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Pant S, Hamadani M, Dodds AJ, Szer J, Crilley PA, Stevenson D, Phillips G, elder P, nivison-Smith I, Avalos BR, Penza S, Topolsky D, Sobecks R, Kalaycio M, Bolwell BJ, Copelan eA. Incidence and reasons for late failure after allogeneic haematopoietic cell transplantation following BuCy2 in acute myeloid leukaemia. Br J Haematol. 2010 feb;148(4):623-6.

Sproat L, Bolwell B, Rybicki L, Tench S, Chan J, Kalaycio M, Dean R, Sobecks R, Pohlman B, Andresen S, Sweetenham J, Copelan e. effect of post-remission chemotherapy preceding allogeneic hematopoietic cell transplant in patients with acute myeloid leukemia in first remission. Leuk Lymphoma. 2010 Sep;51(9):1-6.

Smith SD, Bolwell BJ, Rybicki LA, Kang T, Dean R, Advani A, Thakkar S, Sobecks R, Kalaycio M, Pohlman B, Sweetenham JW. Comparison of outcomes after auto-SCT for patients with relapsed diffuse large B-cell lymphoma according to previous therapy with rituximab. Bone Marrow Transplant. 2010 May 17. [epub ahead of print].

Mickelson DM, Sproat L, Dean R, Sobecks R, Rybicki L, Kalaycio M, Pohlman B, Sweetenham J, Andresen S, Bolwell B, Copelan eA. Comparison of donor chimerism following myeloablative and nonmyeloablative allogeneic hematopoietic SCT. Bone Marrow Transplant. 2011 Jan;46(1):84-9. epub 2010 Mar 22.

Staff

Steven Andresen, DO

edward Copelan, MD

Robert Dean, MD

Hien Duong, MD

Matt Kalaycio, MD

Brad Pohlman, MD

Stephen Smith, MD

Ronald Sobecks, MD

John Sweetenham, MD


laNe eBerharDT | hearT TraNSplaNT reCipieNT

“I’m running around like crazy now.” — Lane eberhardt, 8, new Philadelphia, Ohio. Lane was born

with severe aortic stenosis, a condition that worsened considerably in february 2010. Given just a

few days to live, Lane received a BiVAD in May 2010 that saved his life and enabled him to gain

much needed weight. In December 2010, Lane received his heart transplant. He and his family are

looking forward to their first vacation together — a trip to Hawaii in 2012.


leadership

randall Starling, MD, Mph Program and Medical Director, Heart Transplant Program; Vice Chairman, Department of Cardiovas-cular Diseases; Section Head, Heart Failure and Cardiac Transplant Medicine; Medical Director, Kaufman Center for Heart Failure

Nicholas Smedira, MDProgram and Surgical Director, Heart Transplant Program and Kaufman Center for Heart Failure; Polly and W. Neil Rossborough Chair in Cardiac Transplantation

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CARDIAC TRAnSPLAnTATIOn

2010 highlights

Cleveland Clinic’s Cardiac Transplant Program is a key component of the George M. and Linda H. Kaufman Center for Heart failure. The clinical activity of the Cardiac Transplant Program remained robust in 2010. A total of 238 patients were formally evaluated for transplantation; 95 candidates were listed and 52 transplants were performed, of which five were heart/lung transplants.

The program also continued to achieve excellent outcomes. The Scientific Reg-istry of Transplant Recipients (SRTR) demonstrates that for patients receiving their first transplant between July 1, 2007, and Dec. 31, 2009, 92 percent of adult recipients were alive one year after transplant, compared with the expected 88 percent (based on the characteristics of recipients and donors, as well as on the experience of similar patients throughout the United States). for patients receiving their first transplant between Jan. 1, 2005, and June 30, 2007, the three-year survival rate for our program was 84 percent, compared with the 81 percent that was expected, based on national experience. These excellent results are testimony to the outstanding multidisciplinary care of our transplant program.

eiran Gorodeski, MD, MPH, and Guilherme H. Oliveira, MD, joined the Section of Heart failure in Cardiovascular Medicine in 2010. Dr. Gorodeski specializes in cardiovascular epidemiology, cardiovascular risk modeling and heart failure out-comes. Dr. Oliveira specializes in cardiac oncology, cancer-related heart failure and chemotherapy-induced cardiomyopathy.

Mechanical Circulatory Support

The use of mechanical circulatory support for our end-stage heart failure population continues to grow. fifty-two support devices were implanted in 51 patients at the Kaufman Center for Heart failure. Of these, 28 were implanted as a bridge to transplant and 24 as destination therapy. Access to and expertise with mechanical support devices (Thoratec’s Heartmate II®, Syncardia’s Total Artificial Heart® and HeartWare®) allow us to utilize the optimal device for each individual patient.

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fast facts

Initiated: 1984

first adult heart transplant:Aug. 15, 1984

UnOS approval: March 21, 1988

Medicare approval: June 13, 1988

As of Dec. 31, 2010, 1,521 heart transplants have been performed at Cleveland Clinic.

Cleveland Clinic developed and tested temporary and permanent artificial heart devices.

In 2005, Cleveland Clinic was the first in America to implant the CardioWest Total Artificial Heart after its approval by the fDA. The Total Artificial Heart can provide a bridge to transplantation for patients who are at risk of imminent death from nonreversible biventricular failure.

Pediatric patient Lane eberhardt, featured on page 32, was diagnosed as an infant with a severe aortic stenosis, a heart valve defect that prevents complete blood flow from the heart’s left ventricle to the rest of the body. In february 2010, he experienced trouble breathing and showed other signs of heart failure. By May, he had deteriorated so much that his cardiologists recommended a ventricular assist device. now, the 8-year-old new Philadelphia resident is only the third patient in Ohio to receive the eXCOR Pediatric implant. Manufactured by Berlin Heart GmbH, the device supported the function of Lane’s diseased heart until he was transplanted with a donor heart in December.


The cardiac transplant and heart failure program continues to participate in many clinical research studies. Three important trials concluded in 2010. The goals of these trials were to manage acute heart failure, improve long-term survival, minimize postoperative morbidity in the transplant population, and evaluate the safety and effectiveness of mechanical circulatory support as a bridge to transplant.

Principal Investigator – Dr. Randall StarlingDouble-blind, placebo-controlled, multicenter acute study of clinical effectiveness of nesiritide in subjects with decompensated heart failure. ASCenD-Hf randomized 7,141 patients in 30 countries (including 45 percent from north America) in double-blind fashion and within 24 hours of hospitalization and institution of acute IV therapy for acute decompensated heart failure (ADHf) to receive IV nesiritide or placebo on top of standard therapy. Researchers concluded that the IV vasodilator nesiritide (natrecor, Scios/Johnson & Johnson) doesn’t compromise renal function or increase mortality within a month of its use in ADHf. nor, of note, does it have much more of an effect against acute dyspnea than can be currently achieved in ADHf with conventional diuretics and vasodilators, both of which are less expensive than nesiritide, a mass-production version of a native natriuretic peptide. The trial results were presented at the American Heart Association 2010 Scientific Sessions.

Principal Investigator – Dr. Randall StarlingThe Invasive Monitoring Attenuation Through Gene expression (IMAGe) trial reported that in low-risk cardiac-transplant recipients, a blood assay for rejection-related gene expression is at least as effective a way to monitor for rejection episodes as a strategy of routine endomyocardial biopsy. Patients followed with the AlloMap gene-expression profiling test (XDx, Brisbane, Calif.) who primarily underwent biopsy when indicated clinically, echocardiographically


phone number 216.444.8351

or by the test itself suffered significantly fewer of the invasive procedures than did those who underwent biopsy as the main surveillance method.

The gene-expression test had been validated as a reflection of endomyocardial biopsy results in the multicenter CARGO study; it was approved by the fDA in August 2008.

The group’s report on the IMAGe trial was published online April 22, 2010, in the New England Journal of Medicine and presented at the International Society for Heart & Lung Transplantation 2010.

Principal Investigator – Dr. Nicholas G. SmediraHeartWare, an LVAD, has proven to be a viable alternative to the only other widely used LVAD, Thoratec’s HeartMate II, as a bridge to heart transplant. The findings were presented at the American Heart Association’s 2010 Scientific Sessions.

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Children’s hospital

first pediatric heart transplant: March 30, 1985

four pediatric heart transplants were performed in 2010.

Survival analysis: For patients receiving their first transplant of this type between July 1, 2007, and Dec. 31, 2009, and for the one-month and one-year models; between Jan. 1, 2005, and June 30, 2007, for the three-year model.

Single-organ transplants only; re-transplants excluded. (Source: Scientific Registry of Transplant Recipients, January 2011.)

adult survival

1 month 1 year 3 years

Patient survival percent 96.9 92.4 83.9

pediatric survival




Days on waiting list and post-transplant length of stay (lOS) for patients transplanted in 2010

Mean Median Number

Days waiting 127.9 76.0 52

Post-transplant LOS 16.9 15.0 52

UNOS status of patients transplanted in 2010

Status frequency Percent

1A 29 55.8

1B 18 34.6

2 5 9.6

Number of transplants 1984-2010

Heart Only Heart/Lung Heart/Kidney Heart/Liver

1984-2010 1,488 25 4 4

Total 1,521


Heart Only Heart/Lung Heart/Kidney Heart/Liver

2006 73 2 1

2007 60 3 1

2008 60

2009 54 3 3

2010 47 5

Total* 294 13 1 4

* Includes re-transplants.


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primary diagnoses for patients transplanted in 2010

Diagnosis Number Percent

Coronary artery disease 23 44.2

Dilated cardiomyopathy 11 21.2

Congenital heart defect with surgery 3 5.8

Viral cardiomyopathy 3 5.8

Hypertrophic cardiomyopathy 3 5.8

Postpartum cardiomyopathy 2 3.8

Valvular heart disease 2 3.8

Other 5 9.6

Total 52

heart transplant mortality 2010

Hospital deaths (within 30 days post-transplant) 0



Gorodeski eZ, Chu eC, Chow CH, Levy WC, Hsich e, Starling RC. Application of the Seattle Heart failure Model in ambulatory patients presented to an advanced heart failure therapeutics committee. Circ Heart Fail. 2010 nov 1;3(6):706-14.

Mehra MR, Crespo-Leiro MG, Dipchand A, ensminger SM, Hiemann ne, Kobashigawa JA, Madsen J, Parameshwar J, Starling RC, Uber PA. International Society for Heart and Lung Transplantation working formulation of a standardized nomenclature for cardiac al-lograft vasculopathy-2010. J Heart Lung Transplant. 2010 Jul;29(7):717-27.

Cantillon DJ, Tarakji KG, Hu T, Hsu A, Smedira nG, Starling RC, Wilkoff BL, Saliba WI. Long-term outcomes and clinical predictors for pacemaker-requiring bradyarrhythmias after cardiac transplantation: analysis of the UnOS/OPTn cardiac transplant database. Heart Rhythm. 2010 nov;7(11):1567-71.

Pham MX, Teuteberg JJ, Kfoury AG, Starling RC, Deng MC, Cappola TP, Kao A, Anderson AS, Cotts WG, ewald GA, Baran DA, Bogaev RC, elashoff B, Baron H, Yee J, Valantine HA; IMAGE Study Group. Gene-expression profiling for rejection surveillance after cardiac transplantation. N Engl J Med. 2010 May 20;362(20):1890-900.

Smedira nG, Hoercher KJ, Yoon DY, Rajeswaran J, Klingman L, Starling RC, Blackstone eH. Bridge to transplant experience: factors influencing survival to and after cardiac transplant. J Thorac Cardiovasc Surg. 2010 May;139(5):1295-305, 1305.e1-4.

Ogletree ML, Sweet We, Talerico C, Klecka Me, Young JB, Smedira nG, Starling RC, Moravec CS. Duration of left ventricular assist device support: effects on abnormal cal-cium cycling and functional recovery in the failing human heart. J Heart Lung Transplant. 2010 May;29(5):554-61.

Yoon DY, Smedira nG, nowicki eR, Hoercher KJ, Rajeswaran J, Blackstone eH, Lytle BW. Decision support in surgical management of ischemic cardiomyopathy. J Thorac Cardiovasc Surg. 2010 feb;139(2):283-93.

Cantillon DJ, Gorodeski eZ, Caccamo M, Smedira nG, Wilkoff BL, Starling RC, Saliba W. Long-term outcomes and clinical predictors for pacing after cardiac transplantation. J Heart Lung Transplant. 2009 Aug;28(8):791-8.


Staff

eugene Blackstone, MD

Corinne Bott-Silverman, MD

Gerard J. Boyle, MD

Gonzalo V. Gonzalez-Stawinski, MD

eiran Gorodeski, MD, MPH

Mazen A. Hanna, MD

Robert Hobbs, MD

eileen Hsich, MD

Karen James, MD

Constantine Mavroudis, MD

Tomislav Mihaljevic, MD

Christine Moravec, PhD

Maria Mountis, DO

Guilherme H. Oliveira, MD

Gustavo Rincon, MD

Rene Rodriguez, MD

edward Soltesz, MD

Robert Stewart, MD, MPH

Carmela Tan, MD

W.H. Wilson Tang MD, fACC, fAHA

David Taylor, MD

James Young, MD

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CarOl lazeriCk | COrNeal TraNSplaNT reCipieNT

“Immediately, I felt that I was at the right place and confident that my vision would be restored.” —

Carol Lazerick, 61, Cleveland Heights, Ohio. Carol inadvertently scratched her cornea while remov-

ing a contact lens, resulting in Acanthamoeba keratitis, an infection of the eye. Carol experienced

burning sensations in her eye, extreme light sensitivity and a constant fear of losing her vision. After

the infection healed, Carol received a transplant and now enjoys perfect vision with the aid of either

contact lenses or glasses, enabling her to rekindle her zest for reading, yoga, pottery and swimming.


CORneAL TRAnSPLAnTATIOn

2010 highlights

In 2010, Cole eye Institute surgeons continued to be at the forefront of corneal surgery and research. Team members performed 176 corneal transplants at Cleveland Clinic’s main campus and 59 at our Lorain, Ohio, ambulatory surgery center. Cole eye Institute transplant surgeons also have implanted the Boston Keratoprosthesis as a mode of restoring vision in patients with end-stage corneal disease, including those with corneal blindness from severe chemical trauma.


Cole eye Institute corneal surgeons were among the first in the country to perform a new transplant procedure, Descemet stripping automated endothelial keratoplasty (DSAeK). This procedure involves transplanting only the posterior side of the cornea in eyes with endothelial dysfunction, which greatly acceler-ates visual recovery, reduces surgically induced astigmatism, and entails a smaller wound with less risk of complications from an “open-sky” penetrating keratoplasty. Cole eye Institute surgeons have introduced several technique modifications to improve surgical outcomes, and a clinical study is exploring the optimal tissue preparation techniques for visual outcomes and graft survival. fuchs’ endothelial disease is among the leading indications in the United States for corneal transplantation.

Additional research efforts include:

Principal Investigator – Dr. Steven WilsonCorneal epithelial Cell Growth factors and Receptors.

Principal Investigator – Dr. William DuppsResearch to Prevent Blindness: Supporting basic and translational studies of the biomechanics of keratoconus, a major indication for corneal transplantation.

Principal Investigators – Dr. Richard Rudick and Dr. William Dupps Multidisciplinary Clinical Research Career Development Programs Grant: A collaborative K12 nIH Roadmap initiative involving Cleveland Clinic, Case Western Reserve University, University Hospitals of Cleveland, MetroHealth Medical Center and the Cleveland VA Medical Center.

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Staff

William J. Dupps, MD, PhD

Roger H.S. Langston, MD

David M. Meisler, MD

Allen Roth, MD

elias Traboulsi, MD

Steven Wilson, MD


expertise

Cole eye Institute surgeons are experts in performing all types of transplantation procedures to treat anterior segment diseases. These procedures include:

Corneal transplantation

• Penetrating keratoplasty

• Anterior lamellar keratoplasty

• Intracorneal ring segments for keratoconus

• Descemet stripping automated endothelial keratoplasty (DSAeK)

Limbal stem cell transplantation

Amniotic membrane grafting

Artificial corneas

Approximately 35,000 corneal transplants are performed in the United States every year. Medical histories of all corneal tissue donors are reviewed carefully and blood tests are performed to check for infections. Corneal tissue is scrutinized by specular microscopy to ascertain viability. Corneal transplant success rates are high and rejection rates are low (with the use of only topical immunosuppressive medications).


Ronald R. Krueger, MD: Program Chair and Convenor in Refractive Surgery, Asia Pacific Academy of Ophthalmology; Program Chair, Refractive Surgery Subspecialty Meeting, American Academy of Ophthalmology; editor for Supplements & Special Sections, Journal of Refractive Surgery

David Meisler, MD: Board of Directors, American Board of Ophthalmology

William Dupps, MD, PhD: Distinguished Alumnus Award, College of engineering, The Ohio State University; AAO Practicing Ophthalmologist Curriculum (POC) Refractive Management/Intervention Panel Member; Co-Chair, Corneal Physiology and Biomechanics Symposium, World Ophthalmology Congress, Berlin, Germany, June 2010; Cleveland Clinic/Parker Hannifin Corporation new Ventures Joint Management Committee, Cleveland Clinic Innovations; Associate editor, Journal of Cataract & Refractive Surgery

Steven Wilson, MD: Jose Ignacio Barraquer Career Award at the 11th Interna-tional Congress of Cataract and Refractive Surgery, natal, Brazil, May 19, 2010; Cleveland Clinic Innovators Award, October, 2010; Section editor, Cornea and Ocular Surface, Experimental Eye Research

fast facts

In 2010, 235 corneal transplants were performed at Cleveland Clinic.



de Medeiros fW, Sinha Roy A, Alves MR, Wilson Se, Dupps WJ. Differences in the early biomechanical effects of hyperopic and myopic LASIK. J Cataract Refract Surg. 2010;36:947-53.

Hood CT, Langston RHS, Schoenfield LR, Dupps WJ Jr. Amantadine-associated corneal edema treated with Descemet’s stripping automated endothelial keratoplasty. Ophthalmic Surg Lasers Imaging. 2010 Jul 29;41 Online:1-4.

Krueger RR, Kanellopoulos AJ. Stability of simultaneous topography-guided photorefractive keratectomy and riboflavin/UVA cross-linking for progressive keratoconus: case reports. Journal of Refractive Surgery. 2010 Oct;26(10): in press.

Qian Y, Meisler DM, Langston RH, Jeng BH. Clinical experience with Acanthamoeba keratitis at the Cole eye Institute, 1999-2008. Cornea. 2010 Sep;29(9):1016-21.

Lass JH, Sugar A, Benetz BA, Beck RW, Dontchev M, Gal RL, Kollman C, Gross R, Heck e, Holland eJ, Mannis MJ, Raber I, Stark W, Stulting RD; Cornea Donor Study Investigator Group. endothelial cell density to predict endothelial graft failure after penetrating keratoplasty. Arch Ophthalmol. 2010 Jan;128(1):63-9.

Salomão MQ, Chaurasia SS, Sinha-Roy A, Ambrósio R Jr, esposito A, Sepulveda R, Agrawal V, Wilson SE. Corneal wound healing after ultraviolet-A/riboflavin collagen cross-linking: a rabbit study. J Refract Surg. 2010 Dec 1:1-7. doi: 10.3928/1081597X-20101201-02. [epub ahead of print].

Barbosa fL, Chaurasia SS, Kaur H, de Medeiros fW, Agrawal V, Wilson Se. Stromal interleukin-1 expression in the cornea after haze-associated injury. Exp Eye Res. 2010 Sep;91(3):456-61. epub 2010 Jul 13.

Barbosa fL, Chaurasia SS, Cutler A, Asosingh K, Kaur H, de Medeiros fW, Agrawal V, Wilson SE. Corneal myofibroblast generation from bone marrow-derived cells. Exp Eye Res. 2010 Jul;91(1):92-6. epub 2010 Apr 24.

Miller KL, Walt JG, Mink DR, Satram-Hoang S, Wilson Se, Perry HD, Asbell PA, Pflugfelder SC. Minimal clinically important difference for the ocular surface disease index. Arch Ophthalmol. 2010 Jan;128(1):94-101.

Rocha KM, Vabre L., Chateau nicholas, Krueger RR. enhanced visual acuity and image perception following correction of highly aberrated eyes using an adaptive optics visual simulator. Journal of Refractive Surgery. 2010 Jan;26(1):52-6.

esposito A, Suedekum B, Liu J, An f, Lass J, Strainic MG, Lin f, Heeger P, Medof Me. Decay accelerating factor is essential for successful corneal engraftment. Am J Transplant. 2010 Mar;10(3):527-34. [epub ahead of print] 2010 Jan 5.

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MiChelle JeNkiNS | COMBiNeD iNTeSTiNe /kiDNey TraNSplaNT reCipieNT

“The normal things everyone takes for granted, like eating at a restaurant, I can actually do now.”

— Michelle Jenkins, 37, Parma, Ohio. When Michelle was 21, her kidneys began to fail, resulting in eight

years of peritoneal dialysis and a transplanted kidney in 2005. eventually, scar tissue resulting from the

dialysis covered her intestines and new kidney, causing fluids to accumulate in her stomach and forcing

her to vomit 10 to 15 times per day. She was placed on total parenteral nutrition (TPn) for seven years,

but with a new intestine and kidney, she now enjoys eating normally and contemplating the future.


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InTeSTInAL TRAnSPLAnTATIOn leadership

Cristiano Quintini, MD Program Director, Intestinal Transplant;Surgical Director, Intestinal Rehabilitation and Transplantation Program

Donald kirby, MD Medical Director, Intestinal Rehabilitation and Transplantation Program

2010 highlights

The Intestinal Rehabilitation and Transplant Program (IRTP) completed 10 intestinal transplants in 2010 and an additional transplant in early 2011, bringing the total to 18 intestinal transplants since the program’s inception in June 2008. As a result, the program received CMS certification for Adult Intestinal/Multivisceral Transplantation, effective Dec. 15, 2010.

The program in 2010 performed the first combined kidney and intestine transplant in Ohio. Cleveland Clinic transplant surgeons Cristiano Quintini, MD; Koji Hashimoto, MD; federico Aucejo, MD; and Venkatesh Krishnamurthi, MD, performed the landmark procedure during a single operation that lasted more than 10 hours. The patient, featured on the facing page, has recovered well, is off dialysis and is eating normally for the first time in years.

In addition to an increase in the intestinal transplant activity, the program has experienced a dramatic increase in the number of complex intestinal failure patients treated under the comprehensive care of dedicated gastroenterologists, surgeons, dietitians, psychiatrists and social workers. Some of these patients were treated conservatively by intervention with intestinal rehabilitation mea-sures; others required major surgical intervention. The majority of these patients were transferred from other institutions and were from outside of Ohio.

To accommodate the increase in out-of-state patient interest and referrals, the IRTP now offers MyConsult Online Medical Second Opinion for adult and pediatric patients. following a thorough review of a patient’s medical records and diagnostic tests, staff can render a medical second opinion that includes treatment options or alternatives, as well as recommendations regarding future therapeutic considerations. Additionally, IRTP staff members have already participated in telemedicine videoconferencing – a technology that enables them to interact with patients via Skype™ to avoid unnecessary travel on the part of the patient.

To better serve potential patients, both adult and pediatric, the IRTP offers a 24-hour referral line (216.312.0308) that enables prospective patients and referring physicians to reach an IRTP member at any time.

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fast facts

Initiated: 2008

Performed first adult intestinal transplant in Ohio: June 2008

As of Dec.31, 2010, 17 intestinal transplants have been performed at Cleveland Clinic.

Performed first sequential split liver/isolated intestinal transplant in Ohio: 2009

Performed first kidney/intestine transplant in Ohio: 2010

Medicare approval:Dec. 15, 2010

Patients with irreversible intestinal failure who have failed TPn may be candi-dates for isolated small bowel, combined small bowel and liver, or multivisceral transplantation, depending on how many organs have been affected by the original disease and TPn. Other common indications for intestinal transplant in the adult include dysmotility disorders and benign intra-abdominal tumors (such as desmoid tumors) that require an extensive intra-abdominal evisceration.

In the last 10 years, the outcomes of intestinal transplant have been dramati-cally influenced by the use of newer and more effective anti-rejection drugs. Currently, Cleveland Clinic is the only hospital in Ohio to perform adult intestinal transplants and is among only a few in the United States to do so.

expertise

Cleveland Clinic is consistently ranked by U.S.News & World Report as one of the top two hospitals in treating digestive diseases. It is currently the top-ranked hospital for treating digestive diseases that offers intestinal transplant. Additionally, the American Society for Parenteral and enteral nutrition recognizes Cleveland Clinic as a program of excellence in nutrition support.

awards

The IRTP was awarded the 2010 DnS Research Grant of $10,000 – Primary Investigator Dr. Quintini. Co-investigators Kristen Rhoda, RD, and Mary Jo Porter, RD.

Title: Clinical Indices of Intestinal failure Associated Liver Disease in Parenteral nutrition Dependent Patients: Are we catching it early enough?

Other achievements:

• Jeff Arnovitz, BSn, nP, CCTC, was named Marketing Director of the International Transplant nurses Society.

• Renee Bennett, BSn, CCTn, CCTC, was named President-elect of the International Transplant nurses Society.

• Chris Shay-Downer, BSn, CCTC, was named President of the International Transplant nurses Society.


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24-hour referral line: 216.312.0308

Clinical activities

Patients with intestinal failure are evaluated by a team of experts in nutrition that includes gastroenterologists, intestinal rehabilitation and transplant sur-geons, colorectal surgeons, anesthesiologists, intensivists, dietitians, psychia-trists, pharmacists, nurses, social workers, and ethicists.

When conservative measures fail, intestinal transplant is considered. Three types of intestinal transplantation are performed: isolated small bowel trans-plantation, combined liver and small intestine transplantation, and multivisceral transplantation.

A total of 515 patients were evaluated by the IRTP staff in 2010. Of those, 105 were screened for intestinal transplant and nine were evaluated for transplant. A total of 10 patients underwent intestinal transplant. The remaining patients were treated with diet interventions and medical treatment.

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Number of new intestinal rehabilitation patients 2001-2008

number

2001 3

2002 81

2003 87

2004 80

2005 107

2006 112

2007 151

2008 182

2009 228

2010 259


research

Principal Investigator – Dr. Cristiano Quintini RB 08-879: Outcomes of Intra-Abdominal Desmoid Tumors.

Principal Investigator – Dr. Donald KirbyIRB 09-079: A 24 Week Study of the efficacy and Safety of Teguglutide in Subjects with Parenteral nutrition-Dependent Short Bowel Syndrome.

Principal Investigator – Dr. Cristiano Quintini IRB 09-333: Parenteral nutrition Associated Liver Disease in Patients with TPn Dependent Intestinal failure.

Principal Investigator – Dr. Ezra SteigerIRB 09-1067: Prospective 5 Year follow Up of Patients on Home Parenteral nutrition for Chronic Intestinal failure.

Principal Investigator – Dr. Ezra SteigerIRB 06-261: Plasma Citrulline Levels Predict Home Parenteral nutrition Dependence in Patients with Short Bowel Syndrome.


number

2008* 4

2009 3

2010 10

Total 17

* Cleveland Clinic surgeons began performing intestinal transplants in June 2008.

program growth 2008-2010

new IRTP consults Evaluated for transplant

2008* 228 66

2009 259 75

2010 515 105

* Cleveland Clinic surgeons began performing intestinal transplants in June 2008.


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Principal Investigator – Dr. Ezra SteigerIRB 5248: Registry: Intestinal Rehabilitation Program Database.

Principal Investigator – Dr. Koji HashimotoIRB 09-971: new Desensitization Protocol for Human Intestinal Transplant Candidates with High Panel Reactive Antibodies.


Shatnawei A, Parekh nR, Rhoda KM, Speerhas R, Stafford J, Dasari V, Quintini C, Kirby Df, Steiger e. Intestinal failure management at the Cleveland Clinic. Arch Surg. 2010 Jun;145(6):521-7.

Rhoda KM, Parekh nR, Lennon e, Shay-Downer C, Quintini C, Steiger e, Kirby Df. The multidisciplinary approach to the care of patients with intestinal failure at a tertiary care facility. Nutrition in Clinical Practice. 2010 Apr;25(2).

Staff

Bijan eghtesad, MD

John J. fung, MD, PhD

Koji Hashimoto, MD, PhD

Charles Miller, MD

ezra Steiger, MD

Le-Chu Su, MD, PhD, CPnS


JOSeph ByliCa | liVer TraNSplaNT reCipieNT

“I used to have to take naps four times a day, but when I got home after the procedure, the fatigue

went away instantly, my color was back and I just felt normal again.” — Joseph Byclia, 57, Lorain,

Ohio. Joseph was diagnosed with primary sclerosing cholangitis in 1984. Ten years later he began to

experience jaundice, fatigue and generalized itching. Just a day after his transplant, he began walk-

ing, and three months later he was back on the golf course.


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2010 highlights

In 2010, we performed 133 liver transplants, with improved outcomes and sur-vival rates. Accordingly, our program is one of the largest in the country and the largest in the region, finishing in the top four for volume in the United States. We completed our first adult liver transplant on nov. 8, 1984. Since that date, we have completed more than 1,500 liver transplants, including the first lung-liver transplant in Ohio, in 2007. Wait-list deaths at six and 12 months were below regional and national norms.

The program maintains graft and patient survival above the national averages. In fact, the newest Scientific Registry of Transplant Recipients (SRTR) special report recognized the Cleveland Clinic liver transplant program as one of only five out of 126 programs that have statistically better-than-expected three-year survival rates.

2010 was a time of continued growth and adjustment for the hepatology team as we experienced an increased demand for our services and changes in staff. A total of 477 patients underwent liver transplant evaluation, and 214 patients were listed for transplantation.

The Multidisciplinary Liver Tumor Clinic, under the direction of federico Aucejo, MD, continues to offer state-of-the-art medical care to patients with hepatic tumors through a multidisciplinary team of experienced healthcare professionals in the fields of hepatic surgery, hepatology, radiology and oncology that includes Charles Miller, MD; Robert Pelley, MD; K.V. narayanan Menon, MD; Gordon McLennan, MD; Abraham Levitin, MD; James Spain, MD; and Amanjit Gill, MD. The Liver Tumor Clinic enables patients, within a single visit, to be seen by a board-certified hepatologist, oncologist, surgeon and interventional radiologist.

leadership

Charles Miller, MDProgram and SurgicalDirector, Liver Transplant

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Vera hupertz, MDDirector, Pediatric Liver Transplantation

Nizar N. zein, MDMedical Director, Liver Transplant; Chief, Section of Hepato-biliary Diseases


During the last six months of 2010, the Liver Tumor Clinic reported the following activity:

• 231 visits

• 152 total patients

• 127 new patients, with 87 internally referred, 33 externally referred and seven self-referred

With the large number of patients on the waiting list for liver transplantation and the relative scarcity of organs for transplantation, liver transplant programs have focused on the use of organs from donors that were once considered not suitable/high-risk as “expanded Criteria Donors.” One group of these donors is non-heart-beating donors (donation after cardiac death, or DCD), who are not brain-dead, as donation occurs after the withdrawal of support and complete ar-rest of the cardiac and circulatory system. One of the main complications follow-ing use of the liver from these donors is biliary strictures. This is thought to be secondary to formation of thrombi in the peribiliary vascular system at the time of lack of perfusion of the organs. As a new center protocol to lower the risk of ischemic-type biliary stricture (ITBS) after DCD transplant, we have injected tissue plasminogen activator into the donor hepatic artery on the backtable. We have applied this protocol in 33 patients, with only one graft failure related to ITBS, which has been reported to be up to 33 to 50 percent. We have now embarked on a randomized control trial to prove these initial findings.


• John J. fung, MD, PhD, received the International Congress of the Transplan-tation Society’s Award for Worldwide Impact in Transplantation. The award was presented at the XXIII International Congress of the Transplantation Society in Vancouver, Canada, in August.

• Renee Bennett, BSn, CCTC, CCTn was named President-elect of the Inter-national Transplant nurses Society.

• Kym Houchin was named Co-Director of the Administrative Professional Career Academy.

fast facts

Initiated: 1984

first adult liver transplant: nov. 8, 1984


Medicare approval:Oct. 14, 1992

Performed first lung-liver transplant in Ohio, in 2007.

Active living donor program established for liver transplants.

As of Dec. 31, 2010, 1,570 liver transplants have been performed at Cleveland Clinic.


first pediatric liver transplant: Aug. 26, 1986

five pediatric liver transplants were performed in 2010.



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adult survival



Graft survival percent 93.9 87.7 75.9

pediatric survival




Number of liver transplants by donor type in 2010

Organ Number Deceased Living/Related Living/Unrelated

Liver 121 117 3 1

Liver/kidney 10 10

Liver/intestine/pancreas 2 2

Total 133*

* Includes 6 re-transplants.

Type of liver transplant in 2010

Number Percent

Whole 119 89.5

Split 10 7.5

Reduced/partial 4 3.0


primary diagnoses for liver patients transplanted in 2010

Diagnosis Number Percent

Hepatoma, hepatocellular carcinoma 35 26.3

nASH 16 12.0

Chronic active hepatitis with cirrhosis 13 9.8

Alcoholic cirrhosis 12 9.0

Hepatoma and cirrhosis 8 6.0

Re-transplant graft failure 6 4.5

Primary sclerosing cholangitis 5 3.8

Primary sclerosing cholangitis with ulcerative colitis 5 3.8

Alcoholic cirrhosis with hepatitis C 4 3.0

Autoimmune cirrhosis 4 3.0

PBC 4 3.0

Benign tumor: polycystic liver disease 3 2.2

Cryptogenic cirrhosis 3 2.2

Metabolic disease 2 1.5

Crohn’s disease 2 1.5

Other cirrhosis 1 0.8

Other 10 7.5

Total 133

Days on waiting list and post-transplant length of stay (lOS) for liver patients transplanted in 2010

Mean Median number


Post-transplant LOS 12.26 10.0 124*

* 9 died during initial hospitalization.

liver transplant mortality 2010

Hospital deaths (within 30 days post-transplant) 5*

* Includes 1 liver/intestine/pancreas.


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research

Principal Investigators – Dr. Bijan Eghtesad and Dr. John FungIRB 09-432: A Randomized Controlled Trial of Low Dose Thymoglobulin and extended Delay of Calcineurin Inhibitor Therapy for Renal Protection after Liver Transplant (Sponsor - Genzyme)

• full enrollment of 30 patients (enrolled full contingent over one-year period)

• 26 of 30 enrollees currently on follow-up

• Interim analysis completed and abstracts submitted to American Transplant Congress and International Liver Transplant Society

Principal Investigator – Dr. John FungIRB 08-343: A 24-Month, Multicenter, Open-Label, Randomized, Controlled Study to evaluate the efficacy and the Safety of Concentration-Controlled everolimus to eliminate or to Reduce Tacrolimus Compared to Tacrolimus in De novo Liver Transplant Recipients (Sponsor: novartis)

• Three patients enrolled; one lost to follow-up, two on follow-up

Principal Investigator – Dr. Bijan EghtesadIRB 10-365: enhancing DCD Utilization with Thrombolytic Therapy(Sponsor: HRSA)

• Two liver patients enrolled to date


Berber e, Akyildiz HY, Aucejo f, Gunasekaran G, Chalikonda S, fung J. Robotic versus laparoscopic resection of liver tumours. HPB (Oxford). 2010 Oct;12(8):583-6.

Gunasekaran G, Bencsath K, Hupertz V, fung JJ, Pettersson G, Miller C. Deep hypother-mia with circulatory arrest to aid in the management of suprahepatic vena cava stenosis after liver transplantation. Liver Transpl. 2010 Dec;16(12):1434-6.

Hashimoto K, eghtesad B, Gunasekaran G, fujiki M, Uso TD, Quintini C, Aucejo fn, Kelly DM, Winans CG, Vogt DP, Parker BM, Irefin SA, Miller CM, Fung JJ. Use of tissue plasminogen activator in liver transplantation from donation after cardiac death donors. American Journal of Transplantation. 2010;10:2665-72.

Hashimoto K, Miller CM, Quintini C, Aucejo fn, Hirose K, Uso TD, Trenti L, Kelly DM, Winans CG, Vogt DP, eghtesad B, fung JJ. Is impaired hepatic arterial buffer response a risk factor for biliary anastomotic stricture in liver transplant recipients? Surgery. 2010 Sep;148(3):582-8.

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Hashimoto K, Miller C, Hirose K, Diago T, Aucejo f, Quintini C, eghtesad B, Corey R, Yerian L, Lopez R, Zein n, fung J. Measurement of CD4+ T-cell function in predicting allograft rejection and recurrent hepatitis C after liver transplantation. Clin Transplant. 2010 Sep-Oct;24(5):701-8.

Srinivas TR, Stephany BR, Budev M, Mason DP, Starling RC, Miller C, Goldfarb DA, flechner SM, Poggio eD, Schold JD. An emerging population: kidney transplant candidates who are placed on the waiting list after liver, heart, and lung transplantation. Clin J Am Soc Nephrol. 2010 Oct;5(10):1881-6.

Carey WD. Current Clinical Medicine. 2nd ed. Philadelphia: Saunders/elsevier, 2010.

Dasarathy S, McCullough A. Malnutrition and nutrition in liver disease. In: Dancygier H, ed. Clinical Hepatology: Principles and Practice of Hepatobiliary Diseases. Berlin: Springer, 2010. Chapter 91. p. 1187-207.

eghtesad B, Miller CM, fung JJ. Post-liver transplantation management. In: Carey WD, ed. Current Clinical Medicine. 2nd ed. Philadelphia: Saunders/elsevier, 2010. 564-70.


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Staff

Talal Adhami, MD

federico Aucejo, MD

Robin Avery, MD

David Barnes, MD

Ana Bennett, MD

Mary Bronner, MD

William Carey, MD

Jacek Cywinski, MD

Srinivasan Dasarathy, MD

Bijan eghtesad, MD

Kyrsten fairbanks, MD

John J. fung, MD, PhD

Michael Geisinger, MD

John Goldblum, MD

Koji Hashimoto, MD, PhD

Robert Helfand, MD

Vera Hupertz, MD

Samuel Irefin, MD

Dympna Kelly, MD

Jia Lin, MD, PhD

Theodore Marks, MD, PhD

Arthur McCullough, MD

Charles Miller, MD

Sherif Mossad, MD

Robert O’Shea, MD, MSCe

Brian M. Parker, MD

Cristiano Quintini, MD

Kadakkal Radhakrishnan, MD

Mangalakaraipudur Ramachandran, MD

Mark Sands, MD

Brian Stephany, MD

Ralph Tuthill, MD

Claudene Vlah, MD

David Vogt, MD

Jamile Wakim-fleming, MD

Charles Winans, MD

Lisa Yerian, MD

nizar Zein, MD


aNDrea COleMaN | DOUBle lUNg TraNSplaNT reCipieNT

“I’m getting a second chance, and I need to make my donor family proud.” — Andrea Coleman, 47,

Brooklyn, N.Y. A diagnosis of pulmonary fibrosis and pulmonary hypertension left Andrea extremely

short of breath and energy. Due to an esophageal condition, Andrea was rejected for transplant at

two new York hospitals. Her pulmonologist referred her to Cleveland Clinic, where she underwent

transplant just a few weeks after being listed. She said she never expected to feel so good and is

looking forward to ice skating and running again.


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LUnG AnD HeART/LUnG TRAnSPLAnTATIOn leadership

2010 highlights

The Lung and Heart/Lung Transplant team at Cleveland Clinic performed 122 lung transplants in 2010. We completed our 962nd transplant since the program’s inception in 1990. We attribute the high numbers and excellent outcomes to many factors, including more aggressive donor utilization, teamwork and strong institutional support. The Lung and Heart/Lung Transplant program has achieved consistent volume year after year while maintaining outcomes that are comparable to national averages year after year. We have received national and international recognition for our commitment to accepting many high-risk patients who otherwise would be declined as lung transplant candidates at other centers.

Our program has established a reputation for accepting challenging, complex cases, which has led to a high referral rate. In 2010, the transplant team evaluated more than 600 patients with various forms of end-stage lung disease from across the United States as well as other countries. We have an established and streamlined referral and evaluation process that allows for rapid evaluation and listing for transplantation. High-risk patients are invited to complete an inpatient evaluation process. In fact, 50 percent of our patients receive a transplant in about 2.7 months, compared to a national average of 50 percent receiving a lung in 5.6 months or less. The majority of our patients spent an average of about 60 days on the waiting list in 2010 before they were transplanted.

Our hospital and 30-day mortality rates remain low despite heightened case severity. Median and long-term outcomes continue to exceed national averages for lung transplantation, with a one-year survival rate of 83.4 percent and a three-year survival rate of 70.9 percent. A continued emphasis on quality assurance and quality improvement remains central to the program, reflected by a post-transplant length of stay of a median of 17 days.

The lung transplant staff expanded in 2010 with the addition of Charles Randy Lane, MD; Olufemi femi Akindipe, MD; and Douglas Johnston, MD. Dr. Lane specializes in lung transplantation and advanced lung disease. Dr. Akindipe

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Marie M. Budev, DO, Mph, fCCp Program and Medical Director, Lung Transplant

kenneth McCurry, MDProgram and Surgical Director, Lung and Heart/Lung Transplant (2010)


fast facts

Set world record for number of lung trans-plants performed in a single year: 2009

Initiation date: 1990

first adult lung transplant: feb. 14, 1990

first liver-lung transplant:Jan. 31, 2007

first double lung transplant with bronchial artery revascularization performed Dec. 15, 2007, at Cleveland Clinic.

Performed first lung/liver transplant in Ohio, in 2007.


Medicare approval:Oct. 22, 1997

As of Dec. 31, 2010,962 lung transplants have been performed at Cleveland Clinic.

specializes in lung transplantation. Dr. Johnston specializes in adult cardiac surgery, surgery of the aortic valve and root, mitral and aortic valve repair, coronary artery surgery, reoperative cardiac surgery, and endovascular cardiac interventions.

awards

Marie Budev, DO, received a sub-award from the nIH for the HALT Trial — Treatment of Anti-HLA Antibodies to Prevent BOS after Lung Transplantation.

Kenneth McCurry, MD, received an nIH sub-award for the ReSULT Trial — Reflux Surgery in Lung Transplantation.


A premier component of the Cleveland Clinic Lung Transplant program is our involvement and commitment to advancing the field of lung transplantation. Our center was the only center to receive both nIH R34 grants offered for the first time in 2010 focusing on treatments for antibody mediated rejection and effects of gastroesophageal reflux on lung function after lung transplantation.

Our program continues to participate in many national and international trials addressing important issues impacting lung transplantation including infectious issues, the use of aerosolized cyclosporine as an immunosuppressant, factors impacting early graft dysfunction and medical regimens that may reduce the incidence of chronic rejection. Our surgical team is currently one of the most experienced teams in the country in donation after cardiac death (DCD) and is involved in research with ex vivo perfusion and ischemia-reperfusion injury. Our center is the only center in the country currently performing bronchial artery revascularization (BAR) in an effort to reduce impaired airway healing after lung transplantation. During a lung transplant with BAR, surgery includes an additional connection between a recipient artery and the diminutive donor lung bronchial arteries. Thus, a normal bronchial blood supply is restored.

expertise

Our highly experienced physicians are frequently sought for their opinions and advice. They have served on the advisory boards of various organizations that have helped advance lung transplantation, including the American Thoracic Society, the International Society for Heart and Lung Transplantation, the United network for Organ Sharing, the American College of Chest Physicians, and the World Transplant Congress.


phone Number 216.444.8282

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As part of a statewide quality assurance program, we continue to actively par-ticipate in the State of Ohio Solid Organ Transplantation Consortium, providing educational programs and hosting site visits for other programs in the state.

lung transplants 2010

number Percent

Double 71 58.2

Single 51 41.8 (26 left and 25 right)

Total 122*

* Includes 1 re-transplant.

lung transplant mortality 2010

Hospital deaths (within 30 days post-transplant) 6



lung: adult survival




heart/lung: adult survival






Organ Double Single Total

Lung 497 436 933

Heart/lung 25 25

Lung/liver 4 4

Total 526 436 962

Days on waiting list and post-transplant length of stay (lOS) for lung patients transplanted in 2010

Mean Median number



* 13 patients not discharged as of Jan. 26, 2011, and 7 died during initial hospitalization.

* (includes 2 heart/lung)

** (includes 3 heart/lung and 1 lung/liver)

*** (includes 3 heart/lung and 3 lung/liver)

**** (includes 5 heart/lung)

Number of lung transplants 2006-2010

Single Double Total

2006 21 43* 64

2007 15 57** 72

2008 28 29 57

2009 46 111*** 157

2010 51 71**** 122

Total 161 311 472


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publications

nakao A, Kaczorowski DJ, Wang Y, Cardinal JS, Buchholz BM, Sugimoto R, Tobita K, Lee S, Toyoda Y, Billiar TR, McCurry KR. Amelioration of rat cardiac cold ischemia/reperfusion injury with inhaled hydrogen or carbon monoxide, or both. J Heart Lung Transplant. 2010;29(5):544-53. epub 2009.

Kumar D, Husain S, Chen MH, Moussa G, Himsworth D, Manuel O, Studer S, Pakstis D, McCurry K, Doucette K, Pilewski J, Janeczko R, Humar A. A prospective molecular surveillance study evaluating the clinical impact of community-acquired respiratory viruses in lung transplant recipients. Transplantation. 2010;89(8):1028-33.

McCurry KR. “Immune Tolerance.” In: Lung Transplantation, Vigneswaran WT and Garrity eR (eds.), new York, nY: Informa Healthcare.

Mangi AA, Mason DP, Yun JJ, Murthy SC, Pettersson GB. Bridge to lung transplantation using short-term ambulatory extracorporeal membrane oxygenation. J Thorac Cardiovasc Surg. 2010.

Pettersson GB, Yun JJ, norgaard MA. Bronchial artery revascularization in lung transplantation: techniques, experience, and outcomes. Curr Opin Organ Transplantation. 2010;15:572-77.

Pettersson GB, Budev M. The role of ischemica in postlung transplantation complications. Curr Opin Organ Transplantation. 2010;15:549-51.



Idiopathic pulmonary fibrosis 56 45.9

COPD/emphysema 29 23.8

Cystic fibrosis 9 7.4

Pph (Primary pulmonary HTn) 5 4.1

Alpha-1 antitrypsin deficiency 4 3.3

Scleroderma - pulmonary HTn 3 2.5

Mixed connective tissue disease 2 1.6

Sarcoidosis 2 1.6

Sjogren’s syndrome 2 1.6

Other 10 8.2

Total 122


Danziger Isakov L, Budev MM. “Viral Infections” In: Lung Transplantation, Vigneswaran WT and Garrity eR (eds.), new York, nY: Informa Healthcare, 2010.

Vakil n, Mason DP, Yun JJ, Murthy SC, Budev MM, Pettersson GB. Third time transplant in a patient with cystic fibrosis. Thorac Cardiovasc Surg. 2011 Jan;141(1):e3-5. epub 2010 nov 18.

Srinivas TR, Stephany BR, Budev M, Mason DP, Starling RC, Miller C, Goldfarb DA, flechner SM, Poggio eD, Schold JD. An emerging population: kidney transplant candidates who are placed on the waiting list after liver, heart, and lung transplantation. Clin J Am Soc Nephrol. 2010 Oct;5(10):1881-6. epub 2010 Sep 2.

Vakil n, Su JW, Mason DP, Reyes KM, Murthy SC, Pettersson GB. Allograft entrapment after lung transplantation: a simple solution using a pleurocutaneous catheter. Thorac Cardiovasc Surg. 2010 Aug;58(5):299-301. epub 2010 Aug 2.

Staff

Olufemi femi Akindipe, MD

Jeffrey Chapman, MD

Lara Danziger-Isakov, MD, MPH

Carol farver, MD

Thomas R. Gildea, MD

Steven Gordon, MD

Douglas Johnston, MD

Charles Randy Lane, MD

Michael Machuzak, MD

David P. Mason, MD

Omar A. Minai, MD

Sudish Murthy, MD, PhD

Thomas Olbrych, MD

Gösta Pettersson, MD, PhD

nicholas Smedira, MD


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reBeCCa ryBak | paNCreaS/kiDNey TraNSplaNT reCipieNT

“I’ve been given the opportunity to experience life as a healthy person, and for me that means

experiencing the joy of relationships.” — Rebecca Rybak, 58, elmira, n.Y. Diagnosed with diabetes

42 years prior, Rebecca began to experience dangerous blood sugar fluctuations and extreme fatigue

over the past five years. After receiving a pancreas and kidney transplant, Rebecca says she feels 15

years younger.


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2010 highlights

In 2010, a total of 22 pancreas transplants were performed, including 12 kidney/pancreas transplants and two pancreas/intestine/liver transplants. This brings the total number of transplants performed since the beginning of the program to 299. Clinical outcomes continue to remain excellent. for patients receiving a pancreas/kidney or pancreas-alone transplant in 2010, survival was 100 percent.

The majority of pancreas transplants performed at Cleveland Clinic result from diabetes.


The introduction of specific solid phase assays and improved histological recognition has made the detection of antibody-mediated rejection of organ allografts more reliable. Antibody-mediated rejection is now emerging as a common cause of graft injury and loss, both early and late after transplant. Unfortunately, the treatment of antibody-mediated rejection has been limited to attempts at removal of the offending antibody from the serum or blocking its effects. Recently, the drug bortezomib, an inhibitor of cytoplasmic proteosomes that has been used for multiple myeloma, has been used by the Cleveland Clinic kidney transplant team to treat antibody-mediated rejection.

In the Dec. 27, 2010, edition of Transplantation, Drs. flechner et al. report initial experience in using the proteasome inhibitor bortezomib to treat established antibody-mediated rejection in 20 patients. The researchers concluded that the bortezomib-containing regimen demonstrated activity in antibody-mediated rejection but seemed to be most effective before the onset of significant renal dysfunction or proteinuria. The best use of bortezomib to treat antibody-mediated rejection should be evaluated in controlled trials using dosing strategies that include longer courses or retreatment schedules.

leadership

Venkatesh krishnamurthi, MDProgram and Surgical Director, Pancreas Transplant

emilio poggio, MD Medical Director, Pancreas Transplant; Director, Renal Function Laboratory

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fast facts

Initiated: 1985

first pancreas transplant: March 22, 1988

first kidney/pancreas transplant: Oct. 23, 1985

As of Dec. 31, 2010, 174 kidney/pancreas, 117 pancreas, 4 liver/pancreas, 3 pancreas/intestine/liver and 1 pancreas/intestine transplants have been performed at Cleveland Clinic.

Additional studies include:

Principal Investigators – Dr. David Goldfarb, Dr. Robert Fairchild and Dr. Emilio PoggioKidney and pancreas transplant program bio-repository: In collaboration with the Lerner Research Institute, the Kidney and Pancreas Transplant Program has initiated a collection and storage of biospecimens (blood, urine, biopsy tissue) from kidney and pancreas transplant recipients who receive an organ at Cleveland Clinic. These biospecimens are to be used in the future to develop and test novel biomarkers that will eventually translate into better patient care. This is one of the most important endeavors currently ongoing in the research aspect of the program.



pancreas: adult survival




pancreas/kidney: adult survival


Patient survival (%) 100.0 95.4 79.4

Pancreas graft survival (%) 95.5 85.1 73.4

Kidney graft survival (%) 95.5 87.8 79.4


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Number of pancreas transplants in 2010

Organ Number Percent

Pancreas 8 36.4

Pancreas/kidney 12 54.5

Pancreas/intestine/liver 2 9.1

Total 22*

* includes 2 re-transplants.

Days on waiting list and post-transplant length of stay (lOS) for pancreas patients transplanted in 2010

Mean Median number



* 1 patient died during initial hospitalization receiving two grafts (intestine/liver/pancreas).

pancreas transplant mortality 2010

Hospital deaths (within 30 days post-transplant) 1*

* intestine/liver/pancreas.



Diabetes 19 86.4

Re-transplant/graft failure 2 9.1

Other 1 4.5

Total 22

phone Number Pre-Transplant:216.444.6996

Post-Transplant: 216.444.8949



Refer to list of publications on page 78 (renal).

Staff

Robin Avery, MD

Richard fatica, MD

Venkatesh Krishnamurthi, MD

Sherif Mossad, MD

Saul nurko, MD

emilio Poggio, MD

John Rabets, MD

Titte Srinivas, MD

Brian Stephany, MD

Alvin Wee, MD

Charles Winans, MD


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Dale rUSNik | kiDNey TraNSplaNT reCipieNT

“The most important thing to accept is that God is in control. The most important thing to do is

to be compliant with your doctor’s advice.” — Dale Rusnik, 59, Chesterland, Ohio. for 4 ½ years,

Dale underwent dialysis due to focal segmental glomerulosclerosis, a kidney disease. Thanks to a

transplant last year, Dale no longer requires dialysis and is back to exercising and working at his job

in information technology.


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RenAL TRAnSPLAnTATIOn leadership

David a. goldfarb, MDProgram and Surgical Director, Renal Transplant

richard fatica, MDMedical Director, Renal Transplant

2010 highlights

Clinical activity in renal transplantation remained strong at Cleveland Clinic’s Glickman Urological & Kidney Institute in 2010 as we performed 159 transplants.

Transplantation, more than other clinical endeavors, is carried out with signifi-cant regulatory oversight. All Cleveland Clinic programs were among the first to be recertified by CMS. The kidney program also participated in a United net-work for Organ Sharing pilot directed at developing guidelines for living donor programs. The renal transplant program continues to be active in the Paired Donation network, an innovative service for incompatible donor-recipient pairs.


The program in 2010 performed the first combined kidney and intestine transplant in Ohio. Cleveland Clinic liver transplant surgeons Cristiano Quintini, MD; Koji Hashimoto, MD, PhD; and federico Aucejo, MD, performed the liver procedure, and Venkatesh Krishnamurthi, MD, performed the kidney procedure during a single landmark operation that lasted more than 10 hours. The patient, featured on page 44, has recovered well and is eating normally for the first time in years.


The laboratory of Robert L. fairchild, PhD, continues to focus on:

• mechanisms that produce high levels of inflammation early in transplanted tissues and organs, and

• an understanding of how this inflammation directs alloantigen-primed T cells and other leukocytes into allografts and effector mechanisms leading to solid organ graft rejection.

The introduction of specific solid phase assays and improved histological recognition has made the detection of antibody-mediated rejection of organ

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allografts more reliable. Antibody-mediated rejection is now emerging as a common cause of graft injury and loss, both early and late after transplant. Unfortunately, the treatment of antibody-mediated rejection has been limited to attempts at removal of the offending antibody from the serum or blocking its effects. Recently, bortezomib, an inhibitor of cytoplasmic proteosomes that has been used for multiple myeloma, has been used by the Cleveland Clinic kidney transplant team to treat antibody-mediated rejection.

In the Dec. 27, 2010, edition of Transplantation, Drs. flechner et al. report initial experience in using the proteasome inhibitor bortezomib to treat established antibody-mediated rejection in 20 patients. The researchers concluded that the bortezomib-containing regimen demonstrated activity in antibody-mediated rejection but seems to be most effective before the onset of significant renal dysfunction or proteinuria. The best use of bortezomib to treat antibody-mediated rejection should be evaluated in controlled trials using dosing strategies that include longer courses or retreatment schedules.

Other studies include:

Principal Investigator – Dr. Emilio PoggioAlloreactive T cell immunity in human transplant candidates: This is an nIH-sponsored study aimed at characterizing the cellular alloimmune response (T cell reactivity to donor antigens) in kidney transplant candidates and providing insight into immunological risk profiling by using noninvasive immune monitoring techniques. This study is also designed to correlate pre-transplant cellular alloreactivity with post-transplant clinical outcomes.

Principal Investigator – Dr. Stuart FlechnerGenomics for kidney transplantation: The overall objective of this program project is to apply the latest technologies in genomics to advance our understanding of graft injury.

Principal Investigator – Dr. Stuart FlechnerA randomized placebo controlled double-blind comparative study to evaluate the effect of ramipril on urinary protein excretion in maintenance renal transplant patients converted to sirolimus: The purpose of this study is to learn whether ramipril, an ACe inhibitor drug, is safe and effective in minimizing the risk of proteinuria in subjects in whom the immunosuppressive regimen is switched from a calcineurin inhibitor to sirolimus (a noncalcineurin inhibitor medication).

Principal Investigators: Dr. Emilio Poggio and Dr. Titte SrinivasClinical trial in organ transplantation (CTOT-09): Immune monitoring and CnI withdrawal in low-risk recipients of kidney transplants. This is an nIH-sponsored multi-center trial (PI: Dr. Peter S. Heeger) with the goal of developing

fast facts

Initiated: 1963

first Adult Kidney Transplant: January 9, 1963

Medicare Approval: July 1, 1966

UnOS Approval: March 21, 1988

As of December 31, 2010, 3,641 kidney, 174 kidney/pancreas, 51 kidney/liver, 3 kidney/heart and 1 kidney/intestine transplants have been performed at Cleveland Clinic.

Cleveland Clinic developed and refined dialysis tech-niques in the 1950s to enable survival of patients with kidney failure.

We developed one of the first deceased-donor kidney transplant programs in the world, established in 1963.

We established active living donor programs for kidney (laparoscopic live donor nephrectomy) transplant.


first Pediatric Kidney Transplant: April 4, 1963

One pediatric kidney transplant was performed in 2010.


a strategy of immune monitoring that will allow safe withdrawal of calcineurin inhibitors in kidney transplant recipients perceived to be at relatively low risk for immune injury.

Principal Investigators – Dr. Emilio Poggio and Dr. Richard FaticaImmune Tolerance network (ITn524ST)/Clinical Trials in Organ Transplantation (CTOT-12): Associating Renal Transplantation with the ITn Signature of Tolerance (ARTIST study). A multi-center observational study to assess the prevalence of a tolerance signature in renal transplant recipients.

Principal Investigators – Dr. Titte Srinivas, Dr. Stuart Flechner and Dr. Emilio PoggioRenal allograft function and histology following switching from a tacrolimus to sirolimus (SRL)-based immunosuppression — clinical and mechanistic impact. This research study will test the hypothesis that switching from a calcineurin inhibitor (tacrolimus) to sirolimus (Rapamune) in a triple therapy regimen with MMf and steroids in living and or deceased donor renal transplant recipients leads to improvement in allograft structure and function at two years post-transplantation.

Principal Investigators – Dr. David Goldfarb, Dr. Robert Fairchild and Dr. Emilio PoggioKidney and pancreas transplant program bio-repository: In collaboration with the Lerner Research Institute, the Kidney and Pancreas Transplant Program has initiated a collection and storage of biospecimens (blood, urine, biopsy tissue) from kidney and pancreas transplant recipients who receive an organ at Cleveland Clinic. These biospecimens are to be used in the future to develop and test novel biomarkers that will eventually translate into better patient care. This is one of the most important endeavors currently ongoing in the research aspect of the program.

phone Number Pre-Transplant:216.444.6996

Post-Transplant: 216.444.8949

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kidney: adult survival




kidney: pediatric survival




kidney/pancreas: adult survival


Patient survival (%) 100.0 95.4 79.4

Pancreas graft survival (%) 95.5 85.1 73.4

Kidney graft survival (%) 95.5 87.8 79.4

Number of transplants 2010

Organ number Deceased Living/Related Living/Unrelated

Kidney 136 81 29 26

Kidney/pancreas 12 12

Kidney/liver 10 10

Kidney/intestine 1 1

Total 159*

* Includes 18 re-transplants.


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waiting list and post-transplant length of stay (lOS) for kidney patients transplanted in 2010

Mean Median number

Days waiting (deceased donor) 970.0 852.0 104


* 1 patient not discharged as of Jan. 26, 2011.

primary diagnoses for kidney patients transplanted in 2010


Diabetes 46 28.9

Re-transplant/graft failure 18 11.3

Polycystic kidneys 16 10.1

Hypertensive nephrosclerosis 15 9.4

Chronic GN: unspecified 9 5.7

IGA nephropathy 8 5.0

Systemic lupus erythermatosus 7 4.4

focal glomerulosclerosis 6 3.8

Membranous Gn 6 3.8

Calcineurin inhibitor nephrotoxicity 5 3.1

Alport’s syndrome 3 1.9

Chronic glomerulosclerosis 2 1.3

Other 18 11.3

Total 159

kidney transplant mortality 2010

Hospital deaths 0



Srinivas TR, Shoskes DA, eds. Kidney and Pancreas Transplantation – A Practical Guide. new York: Humana Press, Springer, 2010. (This book has contributions from many members of the group.)

flechner SM, fatica R, Askar M, Stephany B, Poggio e, Koo A, Banning S, Chiesa-Vottero A, Srinivas T. The role of proteasome inhibition with bortezomib in the treatment of antibody mediated rejection after kidney-only or kidney-combined organ transplantation. Transplantation. 2010; 90(12):1486-92.

Srinivas TR, flechner SM, Poggio eD, Askar M, Goldfarb DA, navaneethan S, Schold JD. GfR slopes have significantly improved among renal transplants in the U.S. Transplantation. 2010; 90(12):1499-505.

Chueh SC, flechner SM, Goldfarb D, Sankari B, Campbell S. Surgical treatment of renal cell carcinoma in the immunocompromised transplant patient. Urology. 2010; 75:1373-7.

Stevens LA, Schmid CH, Zhang YL, Coresh J, Manzi J, Landis R, Bakoush O, Contreras, G, Genuth S, Klintmalm GB, Poggio eD, et al. Development and validation of GfR-estimating equations using diabetes, transplant and weight. Nephrol Dial Transplant. 2010;25:449-57.

Danziger-Isakov L, Cherkassky L, Siegel H, McManamon M, Kramer K, Budev M, Sawinski D, Augustine JJ, Hricik De, fairchild R, Poggio eD. effects of influenza immunization on humoral and cellular alloreactivity in humans. Transplantation. 2010; 89:838-44.

Schold JD, Srinivas TR, Poggio eD, Stephany BR, flechner SM, Goldfarb DA, Kattan MW. Hidden selection bias deriving from donor organ characteristics does not affect performance evaluations of kidney transplant centers. Med Care. 2010;48:907-14.

Avery RK, Mossad SB, Poggio eD, Lard M, Budev M, Bolwell B, Waldman WJ, Braun W, Mawhorter SD, fatica R, et al. Utility of leflunomide in the treatment of complex cytomegalovirus syndromes. Transplantation. 2010;90:419-26.

Srinivas, TR, Stephany BR, Budev M, Mason DP, Starling RC, Miller C, Goldfarb DA, flechner SM, Poggio eD, Schold JD. An emerging population: kidney transplant candidates who are placed on the waiting list after liver, heart and lung transplantation. Clin J Am Soc Nephrol. 2010;5:1881.

Woodle eS, Daller JA, Aeder M, Shapiro R, Sandholm T, Casingal V, Goldfarb DA, Lewis RM, Goebel J, Siegler M. ethical considerations for participation of nondirected living donors in kidney exchange programs. Am J Transplant. 2010 Jun;10(6):1460-7.

Samplaski, MK, Coleman J, Goldfarb DA. Post-transplantation lymphoproliferative disorder in the renal transplant ureter. Urology. 2010;75:516.


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Staff

William Baldwin, MD, PhD

William Braun, MD

Shih-Chieh Chueh, MD, PhD

Robert fairchild, PhD

Stuart M. flechner, MD

Surafel Gebreselassie, MD

Priya Kalahasti, MD

Jihad Kaouk, MD

Venkatesh Krishnamurthi, MD

Charles Kwon, MD

Charles Modlin, MD, fACS

Joseph nally, MD

Saul nurko, MD

emilio Poggio, MD

John Rabets, MD

Bashir Sankari, MD

Martin Schreiber Jr., MD

Daniel Shoskes, MD

Titte Srinivas, MD

Brian Stephany, MD

Alvin Wee, MD


OliVia warhOp | BONe TraNSplaNT reCipieNT

“I’m looking forward to playing competitive sports and being active instead of sitting on the

couch.”— Olivia Warhop, 14, Pepper Pike, Ohio. Unexplained pain in her leg led to a diagnosis of

an extremely rare cancer called myofibrosarcoma. Olivia underwent reconstructive surgery to remove

and replace a portion of her tibia with a donor bone, plates and screws. Currently undergoing an

intensive rehabilitation program, Olivia is back at school and swimming competitively again.


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2010 highlights

Some 20 disciplines across 11 of Cleveland Clinic’s institutes and ambulatory surgery centers utilize bone and soft tissue during surgical reconstruction. In 2010, Cleveland Clinic used approximately 5,839 tissue segments and obtained hundreds of oocytes and sperm donations for in vitro fertilization.


Cleveland Clinic has established activities in musculoskeletal stem cell research, tissue engineering and musculoskeletal tissue healing at the Orthopaedic Research Center. Cleveland Clinic physicians also have been active in the American Association of Tissue Banks, the American Academy of Orthopaedic Surgeons Committee on Biological Implants and the American Society of Testing and Materials, as well as with the fDA and Centers for Disease Control and Prevention in promoting safety of tissues.

The tissue transplant program includes cardiology/cardiothoracic surgery, bone transplant (including adult and pediatric orthopaedics, spine and neurology), urology, colorectal surgery, vascular surgery, dentistry, plastic surgery, obstetrics and gynecology, andrology and in vitro fertilization, general surgery, and dermatology.

Cleveland Clinic’s Musculoskeletal Tissue Storage facility, directed by Michael Joyce, MD, is a model tissue management program that monitors the safety, effectiveness and availability of musculoskeletal tissue grafts. The program en-sures The Joint Committee standards are met by qualifying all vendors; tracing tissues from receipt through storage, preparation and use; and identifying and reporting recipient adverse events and handling tissue recalls successfully. At Cleveland Clinic, the storage facility requires a swipe badge to enter and has a carbon dioxide tank backup system in case of an electrical failure.

leadership

Michael Joyce, MDMedical Director, Musculoskeletal Tissue Storage Facility

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Cardiology/Cardiothoracic Surgery

Cleveland Clinic’s heart and heart surgery program has been ranked no. 1 in the nation for the past 17 years by U.S.News & World Report. Cleveland Clinic has the largest heart valve surgery practice in the United States, performing 3,388 procedures on our main campus in 2010, including 1,367 valve repairs and 2,063 valve replacements. Of those replacements, 1,656 represented bioprosthesis, 170 mechanical, 75 homograft and six autograft.

Bone Transplant

Adult and Pediatric Orthopaedics: Adult and pediatric procedures are performed to address trauma, bone healing problems and congenital deformities. Large bone replacement for reconstruction after cancer resection also is performed. To provide support, donor bone is used to fill in defects secondary to fractures and joint replacement. The pediatric service uses allograft tissue that is size-matched with the recipient, with the intent that the allograft eventually will be replaced by normal living host tissue.

Sports Medicine: Knee and ankle soft tissue injuries can be surgically repaired using tendons and ligaments from tissue donors. These donated soft tissues also can be used in partial or total joint replacement. Tissue also is used in repairing rotator cuff injuries.

Cleveland Clinic offers a fresh-tissue osteochondral-allograft program via Lifebanc for cartilage defects in the knee. Team members also perform autologous cell-cultured chondrocyte transplantation for cartilage surface defects of the knee, as well as allograft meniscal transplants.

Spine/Neurology: Cleveland Clinic spine surgeons are experienced in the surgical management of spinal stenosis, disc herniation, spinal tumors, spinal trauma, scoliosis, and other complex deformities and disorders of the cervical, thoracic and lumbar spine. These disorders may require bone transplants to help alleviate pain and to enhance the patient’s quality of life.

Urology

U.S.News & World Report has ranked Cleveland Clinic’s urology program one of the top in the United States every year since 1990. The urology program utilizes tissue as a treatment option for incontinence and for the reinforcement of soft tissue after surgery. Tissue allografts also are used in urethroplasties and pubovaginal sling procedures.

fast facts

Initiated: 1983

fresh Osteochondral Graft Transplant Program established in 1998 by the Department of Orthopaedic Surgery, Adult Reconstruction Section.

first sacral bone trans-plant performed by neuro-spine surgeons in 2001.

first mosaicplasty per-formed by Orthopaedic Adult Reconstruction and Sports Medicine surgeons in 2001.

Performed first near-total facial transplant in the United States in 2008.


Colorectal Surgery

Our gastrointestinal disorders program was ranked second in the nation in 2010 by U.S.News & World Report. The Department of Colorectal Surgery utilizes tissue in specialized procedures, including anal fistula repair, using a tissue plug, and ventral hernia repair.

Vascular Surgery

The Department of Vascular Surgery performed more than 2,714 procedures in 2010 (excluding conscious sedation cases and limited to Cleveland Clinic’s main campus). The department frequently uses tissue allografts for repair and recon-struction of weak or severely diseased blood vessels. One-third of all procedures performed by the department are for atherosclerosis, peripheral arterial disease and peripheral vascular disease. Other conditions treated surgically include aneurysms, carotid artery disease and venous disease.

Dentistry

The Department of Dentistry utilizes tissue in the surgical repair of extraction sockets and periodontal defects, as well as during dental implantation. Bone allografts in these procedures promote additional bone growth to strengthen the various implants used.

plastic Surgery

The Department of Plastic Surgery uses tissue (primarily skin grafts) for a vari-ety of procedures and surgeries. These include facial cosmetic surgery, recon-struction of pediatric craniofacial defects, wound coverage, and cosmetic and reconstructive breast surgery.

andrology and In Vitro fertilization

Cleveland Clinic’s Andrology Laboratory and Reproductive Tissue Bank, which has provided therapeutic sperm banking services since 1980, conducts sperm counts and a variety of tests on semen. The fertility Center, part of the Women’s Health Institute, offers a wide range of procedures. They include in vitro fertilization (IVf), intracytoplasmic sperm injection, sperm aspiration, assisted hatching, blastocyte transfer and embryo cryopreservation. The center also obtains egg and sperm donations and offers an IVf surrogate program.

phone Number 216.444.4282

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focus on Quality

To ensure safety and the best possible results, allograft donors are thoroughly screened with an in-depth medical history and tested for viruses and bacteria. Safety procedures follow published rules, standards and guidelines of the fDA and the American Association of Tissue Banks. Our Tissue Transplantation Program also adheres to the new Joint Commission standards that were established in 2007. These standards are meant to provide higher quality assurance and patient safety through the ability to trace all tissues from the donor or source facility to all recipients or other final disposition.

Throughout 2010, the Transplant Center utilized software developed specifically to track tissue implants, ensure compliance and enhance patient safety. The web-based system, Tissue TrackCore, provides an electronic record for all actions associated with tissues received until final disposition and is currently implemented in more than 125 operating and procedure rooms. In 2010 the system was responsible for handling the tracking of the 5,839 tissue segments. It also has electronic interfaces with the Cleveland Clinic Operating Room Information System and receives product and donor information from vendor systems.


Joyce M, Brubaker S, Greenwald AS, Heim C. Improving Safety by Knowing that Your Allograft Has not Been Recalled or Quarantined. American Academy of Orthopaedic Surgeons. Musculoskeletal Allograft Tissue Safety. March 9-13, 2010, new Orleans.

Lietman SA, Joyce M. Bone Sarcomas: Overview of Management, with a focus on surgical treatment considerations.” Cleveland Clinic Journal of Medicine. March 2010.

Staff

Steven Lietman, MD

George Muschler, MD

Maria Siemionow, MD, PhD


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Bioethics

eric Kodish, MD

Paul ford, PhD

Carmen Paradis, MD

Martin Smith, STD

Anthony Thomas, MD

Kathryn Weise, MD, MA

Biomedical engineering

Paul Murray, PhD

endocrinology

Angelo A. Licata, MD, PhD

immunology

Thomas Hamilton, PhD

psychiatry and psychology

Kathy Coffman, MD, fAPM

Quantitative health Services

Jesse Schold, PhD

SUPPORT STAff

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THAnKS TO OUR DOnATIOn AnD PROCUReMenT AGenCIeS

Cleveland eye Bank

founded in 1958, the Cleveland eye Bank is a nonprofit organization dedicated to restoring sight by providing tissue for transplantation, research and teaching. Donated eyes are retrieved, evaluated and distributed by the eye Bank. The Cleveland eye Bank serves almost 5 million people and 60 area hospitals. Last year more than 700 corneas were provided for sight-restoring corneal trans-plants.

for more information, please call 216.844.eyeS or visit clevelandeyebank.org.

lifebanc

Lifebanc is northeast Ohio’s federally designated, nonprofit organ procurement organization (OPO). Increasing organ and tissue donation for those awaiting transplant is one of Lifebanc’s main goals. Working with more than 80 hospi-tals, Lifebanc is responsible for all aspects of the organ and tissue recovery and donation processes, public and professional education programs, and bereave-ment services for donor families. Lifebanc is a member of the United network of Organ Sharing (UnOS) and an accredited member of the Association of Organ Procurement Organizations (AOPO) and the American Association of Tissue Banks (AATB).

for more information, please call 216.752.life (5433) or toll-free888.558.life (5433), or visit lifebanc.org.


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Cleveland Minority Organ Tissue Transplant education program

The Cleveland Minority Organ Tissue Transplant education Program (MOTTeP) is a nonprofit organization that seeks to increase awareness through education and advocacy about organ and tissue donation, disease prevention, and wellness within minority communities of Greater Cleveland.

for more information, or to schedule educational programs, please call 216.229.2690 or visit clevelandmottep.org.

National Marrow Donor program

The national Marrow Donor Program (nMDP) is a nonprofit organization that manages the world’s largest register of volunteer stem cell donors and cord blood units. It facilitates lifesaving blood stem cell transplants for patients fight-ing diseases such as leukemia, aplastic anemia, and other blood and marrow diseases.

for more information, please call 800.MarrOw2 or visit marrow.org.

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Cleveland Clinic Transplant CenterDesk A110

9500 euclid Ave.

Cleveland, Ohio 44195

216.444.2394

800.223.2273, ext. 42394

fax: 216.444.9375

Cleveland Clinic encompasses 2,700 physicians and scientists in 120 specialties and subspecialties. All of these specialties — including pediatrics at the Cleveland Clinic Pediatric Institute & Children’s Hospital — are present in one facility, making multidisciplinary consultation, diagnosis and treatment readily available.

In 2010, Cleveland Clinic was ranked one of America’s top four hospitals, according to U.S.News & World Report’s annual “Best Hospitals Survey.” Cleveland Clinic has been listed among the nation’s top five hospitals every year since 1999. Cleveland Clinic also celebrated 16 years of being ranked as the nation’s no. 1 cardiac care center. In addition, the survey ranks 14 Cleveland Clinic specialty care areas among the nation’s top 10, with three of those areas ranked among the top 2 in the United States.

ABOUT CLeVeLAnD CLInIC

Photography:

Tom Merce

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Referrals

General Patient Referral24/7 hospital transfers or physician consults

800.553.5056On the Web at clevelandclinic.org

Transplant Center216.444.2394 or 800.223.2273, ext. 42394On the Web at clevelandclinic.org/transplant

Services for Physicians

Physician DirectoryView all Cleveland Clinic staff online atclevelandclinic.org/staff.

Referring Physician CenterFor help with service-related issues, information about our clinical specialists and services, details about CME opportunities, and more, contact us at [email protected] or 216.448.0900 or toll-free 888.637.0568.

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 around the globe. To arrange a transfer for STEMI (ST elevated myocardial infarction), acute stroke, ICH (intracerebral hemorrhage), SAH (subarachnoid hemorrhage) or aortic syndromes, call toll-free 877.379.CODE (2633). For all other critical care transfers, call 216.444.8302 or 800.553.5056.

Request for Medical Records216.444.2640 or 800.223.2273, ext. 42640

DrConnect:Improved Communication, Improved Care

DrConnect offers secure, online access to your patient’s treatment progress while at Cleveland Clinic. To establish a DrConnect account, visit clevelandclinic.org/drconnect or email [email protected].

MyConsult:Online Medical Second Opinion

MyConsult securely connects patients to top physician specialists for more than 1,000 life-threatening orlife-changing diagnoses at the click of a mouse. clevelandclinic.org/myconsult or 800.223.2273, ext. 43223

Outcomes Data View the latest clinical Outcomes book frommany Cleveland Clinic institutes atclevelandclinic.org/quality/outcomes.

CME Opportunities: Live and Online Cleveland Clinic’s Center for Continuing Education’s website, ccfcme.com, offers convenient, complimen-tary learning opportunities, from a virtual textbook of medicine (Disease Management Project) and a medi-cal newsfeed refreshed daily to myCME, a system for physicians to manage their CME portfolios. Many live CME courses are hosted in Cleveland, an economical option for business travel.

Services for Patients

Medical Concierge Complimentary assistance for out-of-state patients and families

800.223.2273, ext. 55580 oremail [email protected]

Global Patient ServicesComplimentary assistance for national and international patients and families

001.216.444.8184 or visit clevelandclinic.org/gps

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