Emerging Technology: Latest Anti-reflux Endoscopic ......GERD vs NERD 3) Describe briefly the current medical & surgical treatment for GERD 4) Identify the right patient for anti-reflux

Emerging Technology: Latest Anti-reflux Endoscopic procedures & Surgeries

Simi Jesto Joseph, DNP, RN, APN, NP-C Director of Research & Clinical Services

Gastroenterology Nurse Practitioner GI Solutions of IL

Objectives

1) Describe types of reflux diseases 2) Identify the current diagnostic technology to distinguish

GERD vs NERD 3) Describe briefly the current medical & surgical treatment for

GERD 4) Identify the right patient for anti-reflux procedures

Reflux Diseases

GERD LPRD DGR NERD

Reflux Diseases

1) GERD – Gastroesophageal Reflux

2) LPRD – Laryngopharyngeal Reflux

! Backflow of stomach contents up the esophagus and into the throat 3) DGR – Duodeno-Gastric Reflux

! Duodenal contents (bile acids; pancreatic juice) ! Also called bile reflux

4) NERD – Non-Erosive Reflux

! Typical reflux symptoms caused by the intraesophageal reflux of gastric contents

! No visible esophageal mucosal injury

GERD“ A condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications” (Montreal Consensus)

(AGA, 2008)

GERD Overview

! Gastroesophageal reflux disease (GERD) is a chronic disease which affects an estimated 38 million patients in the U.S

! Weekly in approximately 20-25% of adults2

! Only 19 million are diagnosed annually

! 35% of affected individuals do not seek medical care, preferring to self- medicate

! The most common gastrointestinal diagnosis recorded on outpatient visits since 2006, surpassing abdominal pain3

! Increasing prevalence4

! Aging population

! Obesity

! Changes in diet & physical activity

! Over-prescription of pharmaceutical therapies (PPIs)5

! Americans spend in excess of $10 billion per year on Proton Pump Inhibitors (PPIs)

! The number of PPI prescriptions/year in the United States has doubled since 1999

Lewis, (2006); Pandalfino & Kwialek (2008); Shaheen et al (2006); Vakil et al (2006; Moore et al. 2016)

Pathophysiology of GERD

Photography: Used with permission from (GI Solutions/Arun Ohri, MD)

Typical symptoms have been associated with Barrett’s Esophagus--a condition that increases risk for cancer.*

GERD is Deceptively Complex

Typical Atypical

• Persistent cough • Chronic sore throat • Difficulty swallowing • Frequent swallowing • Asthma • Hoarseness • Excessive throat clearing • Bad breath • Dental erosions or gum

disease • Discomfort in ears & nose

• Heartburn • Chest Pain • Excessive Salivation • Regurgitation • Gas • Bloating • Trouble Sleeping • Sensitive To Some Foods

& Liquids

And

Or

6 million suffer from GERD and asthma

GERD: Symptoms

GERD Clinical Progression

Progression of GERD…

Complications: • Ulceration • Hemorrhage • Strictures • Barrett’s

Esophagus • Adenocarcinom

a (Cancer)

Esophagitis is inflammation of the esophagus. It may be acute or chronic.

Physiological Reflux (Infrequent & Mild)

Symptomatic GERD (Frequent & Intense)

Esophagitis Complex Esophagitis

Symptoms: Typical • Heartburn • Regurgitation Atypical • Chest pain • Difficulty

swallowing • Cough • Asthma • Laryngitis

Esophagogastroduodenoscopy

• Extend of esophagitis • H-pylori gastritis • Ulcers

• Barrett’s esophagus

• Strictures

• Varices

• Angiodysplasias • Mallory-Weiss tear • Tumors

• Gastric polyps


Bravo pH Monitoring System! Catheter-free pH monitoring system ! pH capsule attached to the esophageal wall transmits data

to pager-sized receiver ! Allows normal activities such as dietary habits, showering,

and exercise and does not interfere with sleeping ! 48 to 72 hour PH reading of the esophagus

! Supine reflux

! Night time reflux ! Symptom correlation

! Monitor reflux on PPI as well as

Off PPI


Esophageal Manometry! To accurately define esophageal motor function

! For preoperative assessment of patients being considered for antireflux surgery

! Note: Esophageal manometry is not indicated for making or confirming a suspected diagnosis of GERD

! Indications:

! Achalasia

! Nutcracker esophagus

! Cricopharyngeal Achalasia

! Simultaneous swallows

! Abnormal co-ordination


Esophageal Impedance Testing! 24 hour catheter-based test ! Patient carry the catheter and resume normal activities ! Allowing recognition of both acidic and weakly acidic reflux episodes ! The results of several studies suggest that impedance-pH monitoring is useful in the

evaluation of patients with PPI-resistant typical reflux symptoms, and atypical symptoms: ! Chronic unexplained cough ! Excessive belching ! Rumination ! Motility disorders

! Non-acid reflux

Pritchett, Aslam, Slaughter (2009); Photography: Used with permission from (GI Solutions/Arun Ohri, MD)

Barium x-ray

• X-ray examination of the esophagus, stomach, and first part of the small intestine • Images obtained using fluoroscopy and oral barium • Evaluate the anatomy and function • Air-contrast or double-contrast upper GI • Iodine contrast is used if recent GI surgery or barium allergy • Indications:

• Difficulty swallowing

• An alternative to EGD or manometry if needed

GERD: Esophagitis, NERD, Functional Heartburn?

GERD Endoscopy + Los Angeles A-D esophagitis

-

pH monitoring excess esophageal

acid exposure+ NERD

-

pH monitoring symptom correlation

+ Hypersensitive esophagus

-

Functional heartburn

non-acid reflux

Lifestyle Modifications

GERD Associated Quality of Life Parameters*

Rigorously Timed Meals

Weight Loss Eliminate Smoking

No Pressure On

Stomach

Sleeping in Chair

Inclined Sleeping Position

• Unable to enjoy meals • Sleep disturbances • Fatigue • Reduced overall

productivity • Altered social well-being • Altered emotional well-

being

Eliminate Triggering Foods &

Drink

PPIs

Blocks the secretion of acid into the

stomach

Escalated dosing of more complex medications

…until pills stop working.

H2 Blockers

Blocks the body’s signal to the stomach to produce acid

Antacids

Neutralize or buffer stomach

acid

…and medications come with side-effects and complications

Medical Management

GERD Suffering is Widespread

19 Million Daily

42 Million Weekly

20 Million Monthly

81 Million Total ¼ of Americans

Only And But

10.2 Million Visit a Doctor

6.3 Million Receive Tests to Diagnose

0.05 Million Receive Treatment with a Procedure

134 Millon OTC & Rx

Vitamin B12 Deficiency1

Increased Pneumonia

Risk2

Increased Risk of Osteoporosis

Fractures3

Reduced Gallbladder

Motility4

PPI Interaction with Plavix5 Increased Risk

of Fundic Gland Polyps6

Increased Risk of Bacterial

Gastroenteritis7

Magnesium deficiency8

Increased Risk of C. diff , Small Intestine

Bacterial Overgrowth9

Risks Associated With PPI Use

GERD Symptom and Treatment Continuum

Endoscopic Repair

Anti-Reflux Surgery-Decision

! Anti-reflux surgeries are an effective alternative to medical treatment ! Increases Transient Lower Esophageal relaxation period

! Indications (SAGE Guideline)

! Symptoms refractory to pharmacological therapy

! Have complications of GERD

! Barrett’s esophagus,

! peptic stricture,

! large Hiatal hernia, ! Atypical symptoms, ! and reflux documented on 24hr PH monitoring

(Moore et al. 2016)

Pre-op work up

! 1) Upper Endoscopy

! Visual and histopathological changes

! 2) PH monitoring ! Gold standard for pathologic acid reflux

! 3) Esophageal Manometry

! To identify dysmotility of esophagus

! 4) Barium Swallow ! To determine the anatomy

(Moore et al. 2016)

Anti-reflux procedures

Closed; no reflux

Can’t close; contents reflux

Tight to the scope

Loose to the scope

Normal Anatomy Abnormal Anatomy

Functional Valve Dysfunctional Valve

Physiological Reflux (Infrequent & Mild)

Symptomatic GERD (Frequent & Intense)

Vs.

Solution:

Restore anatomy to

normal

by

Repairing valve

to

Resolve symptoms

Photography: Used with permission from (Endogastric Solutions)

Laparoscopic (LNF) vs Open technique for GERD (CNF)

! Laparoscopic NISSEN Fundopliction vs Conventional NISSEN Fundoplication

! Aim: re-create and restore normal physiologic function of LES, reconstruction of the Hiatus, and repair of hernia

! LNF-Preferred approach and gold standard for surgical treatment

! Longer operative time ! Shorted hospital stay ! Low perioperative morbidity

! Decreased pain

! Low rate of abdominal hernias ! Low rate of infections

(Moore et al. 2016)

Partial Vs Total FundoplicationToupet ! Partial-270 degree ! Fewer symptoms of bloating ! Able to vomit

Nissen ! Total-360 degree ! High rate of dysphagia ! Flatulance ! Bloating

(Moore et al. 2016)

Toupet vs Nissen

! Toupet done in 3.0 cm and 1.5 cm valve length ! 3.0 is superior in controlling reflux ! Dysphagia is higher in 3.0

! More studies required

(Moore et al. 2016)

Anterior (DOR) vs Nissen

! 120 degree anterior fundoplication

! Less post operative dysphagia ! Shown less effective in controlling reflux ! Most patients required re operation

(Moore et al. 2016)

Comparison

Nissen

DOR

Toupet

Advantages Disadvantages

Effective in reflux control

Less post-op Dysphagia

Less Post-op dysphagia

Flatulance, bloating, dysphagia

More re opertaions

Length of the wrap determines the quality of reflux control

(Moore et al. 2016)

Stomach Intestinal Pylorus Sparing Surgery (SIPS)

! Modified approach for morbidly obese pts ! Modified duodenal switch

! Involves sleeve gastrectomy and attach pylorus to the midgut located 3 meters from the terminal Ileum

! Novel technique for both obesity and GERD ! Early results are encouraging

(Zaveri et al. 2015)

Anti-reflux surgery-conclusion

! LNF is the gold standard procedure

! Failure rate-3%-16%

! Etiology-Slipped fundoplication or herniation of the wrap ! Re-operation is safe ! High complication rates-gastric or esophageal perforation

! Longer operative times

! Higher conversion to open approach

(Moore et al. 2016)

Antireflux Endoscopic Procedures (History)

! Implanting Technique - Enteryx

! Radio Frequency - Stretta

! Suturing Devices: - Endocinch

- Plicator


! Inclusion Criteria: ! 18-80 years of age for adults or > 12 years and 25 kg for children

! Chronic symptomatic GERD for > 6 months

! Persistent GERD symptoms despite PPI therapy

! Demonstrated reflux (48-h pH metry, UGI radiography or esophagitis B or C)

! Deteriorated gastroesophageal junction (Hill grade II-III)

- Patient willing to comply with post-operative dietary recommendations

! Exclusion Criteria: ! BMI > 35

! Irreducible hiatal hernia > 2 cm

! Esophagitis grade D

! Esophageal ulcer, fixed stricture or motility disorders

! Dysphagia

Patient Selection Criteria

TIF ( Transoral Incisionless Fundoplication)

➢ No incisions

➢ No scarring

➢ No incisional

herniation

➢ Less nosocomial

infection

➢ No dysphagia


TIF


TIF

! 3rd generation in reflux surgery ➢ Surgical reconstruction transorally ➢ Sterile, single use device

➢ An evolution of current surgical procedure

➢ Based on long standing surgical principles

➢ Physiologically less invasive

➢ Future options open-adjustable

➢ Adaptive to patients

anatomy


Endoscopic Retroflex View Before & After TIF Procedure

Photography: Used with permission

from (GI Solutions/Arun Ohri, MD)

TIF

EvidenceOutcomes

Experience

Studied in over 40 peer-reviewed publications with

outcomes for over 700 individual

patients.

Safety

Over 15,000 patients treated

consecutively over 10 years.

High level of efficacy in improving

subjective and objective measures

of GERD.

Commercial SAE rate less than

0.4% Absent long-term

side-effects associated with other treatment

options.

RESPECT

• A multi-center, randomized, single-blind, controlled TIF/Placebo vs. Sham/PPIs trial

• To compare safety and effectiveness of TIF vs. Sham/PPIs in patients with “troublesome symptoms” specifically regurgitation

• 2:1 ratio TIF/Placebo group ( n=80) vs. Sham/PPI group (n=40)

TEMPO

• A multi-center, randomized, open-label, controlled TIF vs. PPI trial

• To compare safety and efficacy of TIF vs. PPIs for the treatment of chronic medically refractory GERD

• 2:1 ratio TIF group (n=28) vs. PPIs group (n=14)

TIF REGISTRY

• A multi-center, prospective, open-label, post market registry

• To evaluate the safety and efficacy of TIF in a broad range of GERD patients treated in routine clinical practice

• 274 patients treated with TIF procedure

STAR REGISTRY (AGA)

• A multi-center, prospective, open-label, post market registry

• To compare the safety and efficacy of TIF procedure vs. Laparoscopic Nissen Fundoplication Surgery (LNF)

• 1:1 ratio TIF group (n=250) vs. LNF group (n=250)

Level 1 and 2 Clinical Studies Detailed

(Trad et al, 2014; Bell et al, 2012)

In the TEMPO randomized, controlled trial comparing the TIF 2.0 procedure to maximum dose PPI therapy, outcomes at 6 months:

97%of patients eliminated daily

regurgitation 50% in the PPI group VS

90%of patients had esophagitis

healed 38% for PPI groupVS

62%of patients eliminated all

symptoms 5% for PPI groupVS

54%of patients had esophageal pH

normalized 52% in the PPI groupVS

Trad et al(2014)

Endoscopic Fundoplication! All outcome measures of TIF were sustained and statistically unchanged between 6- and 12–M follow-up

! 84% of TIF patients remained completely off PPI at 12-M vs. 90% at 6-M follow-up

! Esophagitis was healed or reduced in 100% of TIF patients at 12-M vs. 90% at 6-M

! 77% of TIF patients experienced global elimination of regurgitation and atypical symptoms off PPIs at 12-M

! In the crossover group of patients, 71% were completely off PPIs 6 months post-TIF

! In crossover patients, TIF was superior to high-dose PPIs in eliminating typical and atypical GERD symptoms

Endoscopic Fundoplication

! TIF provides significant control of regurgitation, atypical symptoms and healing of esophagitis in patients with small hiatal hernias and an incomplete response to PPIs

! TIF avoids the undesirable post-fundoplication side-effects (dysphagia, gas-bloat and flatulence) commonly associated with laparoscopic anti-reflux procedures

! In a well selected patient population, TIF is a safe, viable endoscopic alternative to existing anti-reflux procedures

! TIF may also be viewed as an adjunct to PPI therapy in patients with incomplete control of regurgitation and atypical symptoms

! Outcomes of this study are consistent with other recently published data and demonstrate durability of results 12 months following TIF

TIF vs Nissen or Toupet

! Safe and efficacious in symptom control

! TIF is a paradigm shift in tx of GERD

! TIF has shorter operative time and length of stay

! No complications or no conversions

! High patient satisfaction

(Toomey et al. 2014)

Conclusion• Transoral fundoplication achieved elimination of daily dependence on

PPI-75-80% (6 yrs data)

• Troublesome regurgitation was resolved in a greater proportion of patients treated with TIF than with omeprazole

• TIF appears to be safe, without fundoplication side effects

• Intra-esophageal acid control improved following TIF

• TIF should be considered in GERD patients with small or absent hiatal hernia who suffer from troublesome regurgitation, despite PPI therapy

(Testoni, Testoni, mazzoleni, Vailati, & Passaretti, 2015)

Linx

! Minimally invasive laparoscopic procedure

! Linx is implanted outside the LES

! Preserves normal function-can belch and vomit

! Designed for lifetime, quarter in size, made of Titanium

! One type is safe in MRI scanning

LINX® Reflux Management System

! FDA approved in 2012 ! Proven safe and effective ! Minimally invasive procedure ! Designed to be a permanent solution for GERD ! Long term 5 – year data published in Clinical Gastroenterology & Hepatology May 2016

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Journal Support

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LINX® Procedure

►Laparoscopic, minimally invasive procedure

►Generally completed in less than one hour

►Patients typically go home the same day and resume a normal diet as soon as tolerated

►No alteration to the stomach

►Patients generally retain ability to belch and vomit; reduces gas bloat

►Removable

47

LINX® Benefits

! 87% of patients completely eliminated medication use1

! 98% of patients reported no bothersome heartburn affecting their nightly sleep2

! 98% of patients required no daily change to their diet from heartburn2

! 94% of patients were satisfied with their overall condition after LINX1

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1. Ganz, et al., Esophageal Sphincter Device for Gastroesophageal Reflux Disease. The New England Journal of Medicine; 368; 8: 719-727. 2. Data on File, Torax Medical.

How LINX® Works

LINX helps keep the LES closed to prevent reflux

LINX expands to allow for normal swallowing

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How LINX® Works

MUSE- EndostaplerSystem! FDA approved-2014

! The innovative endoscopy system is for the treatment of Gastroesophageal Reflux Disease (GERD).

! It performs an anterior fundoplication in lieu of current surgical procedures, without opening the abdominal cavity.

! SRS™ endoscope distal section including several sophisticated innovative technologies such as a surgical stapler, miniature camera and an ultrasound sensor

! (http://www.medigus.com)

! The SRS system has the following principal advantages: Provides the same results as in gold standard laparoscopic surgery.

! Faster than laparoscopic surgery. ! A more attractive treatment than either surgery or lifelong medication. ! A more efficient and cost effective procedure. ! Less trauma to patient with no incisions. ! The entire endoscope is disposable.

! (http://www.medigus.com)

Endostim Therapy

✓ Bipolar lead delivers low energy electrical impulses to LES ✓ Implanted through laparoscopic procedure ✓ Single-center (Chile) and International multicenter open-label trials

• Prospective pilot studies evaluating safety and efficacy • 6-M and 12-M follow-up results published for single-center study

✓ Initial studies have demonstrated safety and efficacy at 12 months follow-up in PPI-refractory sufferers

✓ Still upstream, but a potential treatment option for GERD

Ideal GERD Treatment

Provider Wish List Patient Wish List

“I wish I could feel normal again.” “I need a decent night’s sleep.”

“I don’t want to take pills anymore.”

“I want to avoid an invasive surgery.”

“I don’t want side-effects.”

• Subjective Improvement: – Symptom control – QOL scores

– Medication use – Satisfaction

– Durability

• Objective Improvement: – pH-metry – Esophagitis – Safe, few and minor complications – Minimal side-effects

Thank you

GI SOLUTIONS

References! AGA (2008). American Gastroenterology Association medical position statement on the management of Gastroesophageal Reflux Disease. Gastroenterology, 135: 1383-1391

!Bell, R.C, Mavrelis, P.G., Barnes, W.E., Dargis, D., Carter, B.J.,….Ihde, G.M. (2012). A prospective multicentered registry of chronic gastroesophageal disease receiving transoral incisionless fundoplication. Americal College of Surgery, 215(6):794-809

! De Vault, K.R. & Castell, D.O. (2005). Updated guidelines for the diagnosis & treatment of Gastroesophageal Reflux Disease. American Journal of Gastroenterology, 100:190-200

! Lewis, JV. (2009) (Editorial). Gastroesophageal Reflux Disease and Obesity. Southern Medical Journal, 102(10); 995-996

! Pandalfino,J.E. & Kwialek, M.A. (2008). Use and utility of the Bravo Ph capsule. Journal of Clinical Gastroenterology, 42:571-578

! Shaheen, N.J., Hansen, R.A., Morgan, D.R., Gangarosa, L.M., Ringel, Y., Thiny, M.T., Russo, M.W., Sandler, R.S. (2006). The burden of gastrointestinal and liver disease. American journal of Gastroenterology, 101:2128-2138.

!Moore, M., Afaneh, C., benhuri, D., Antonacci, C., Abelson, J., & Zarnegar, R. (2016). Gastroesophageal reflux disease: A review of surgical decision making., World Journal of gastrointestinal Surgery, 8 (1): 77-83

! MUSE endostapler system Photography: Retrieved from http://www.medigus.com ! Pritchett, J.M., Aslam, M., Slaughter, J.C. (2009). Efficacy of esophageal impedence/PH monitoring in patients with refractory gasroesophageal reflux disease, on and off PPI therapy. Clinical Gastroenterology & Hepatology,

7: 743-748

! Toomey, P., Teta, A., Patel, K, Ross, S., Sukharamwala, P., & Rosemurgy, A.S. (2014). Transoral Incisionless Fundoplication: Is it as safe and efficacious as a Nissen or Toupet Fundoplication?. The American Surgeon, 9(80): 860-867

!Testoni, P.A., Testoni, S., Mazzoleni, G., Vailati, C., & Passaretti, S. (2015). Long-term efficacy of tranoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-centered study, 29: 2770-2780

! Trad,K.S., Barnes, W.E, Simoni, G., Shughoury, A.B., Marvelis, P.G., Heise, J.A., Turgeon, D.G., & Fox, M.A. (2014). Transoral incisionless fundoplication effective in eliminating GERD symptoms in partial responders to proton pump inhibitor therapy at 6 months: The TEMPO randomized clinical trial. Surg Innov, 22 (1): 26-40

! Photography: Used with permission from (GI Solutions/Arun Ohri, MD)

! Photography: Used with permission from (Endogastric Solutions)

! Vakil,N., Vanzanten, S.V, Kahrilas, P., dent, J., Jones, R. & Global consensus group. The Montreal definition and classification of Gastroesophageal Reflux Disease: A global evidence-based consensus (2006). American Journal of Gastroenterology, 101:1900-1920

! Zaveri, H., Surve, A., Cottam, D., Richards, C., Medlin, W., Belnap, L., Cottam, S., & Cottam, A. (2015). Stomach intestinal pylorus sparing surgery (SIPS) with laparoscopic fundoplication (LF): a new approach to gastroesophageal reflux disease 9GERD) in the setting of morbid obesity. 4: 596

Documents

Emerging Technology: Latest Anti-reflux Endoscopic ......GERD vs NERD 3) Describe briefly the current medical & surgical treatment for GERD 4) Identify the right patient for anti-reflux