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Multidisciplinary Collaboration. Personalized Treatment Strategies. Patient Advocacy.

Anti-Reflux Surgery Indications & Technique

GERD Definition

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Disclosures

• Torax / J&J

• Medtronic

• EndoStim All are relevant to this talk. • Bard

• Gore

1. Reflux starts with a DYNAMIC failure of the lower esophageal sphincter (LES).

2. The Acid Pocket

3. Bile & Acid Reflux exposure

4. Persistent reflux and inflammation leads to STRUCTURAL failure of the LES

5. Exposure/Inflammation/Esophageal Dilation/ Intestinalization of Cardiac mucosa/ Esophageal damage/ Barrett's esophagus/ Esophageal adenocarcinoma are a CONTINUUM.

6. Anti-reflux surgery works because it stops effacement of the LES

Key Concepts in GERD

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Concept 1- LES Effacement

Concept 2- The Acid Pocket

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Concept 3- Bile Exposure at Weak Acid pH

Documented Composition of Reflux in 273 Patients

30%56%

14%

Acid + Bile

Acid Only

Bile Only

DS. Oh, et al. The Impact of Reflux Composition on Mucosal Injury and Esophageal Function. J Gastrointest Surg 2006

Concept 4- Loss of LES Length with GERD

NormalGEJ + SCJ

New SCJ

OriginalGEJ

Squamous epithelium replaced by metaplastic

cardiacepithelium with loss of LES

length

OxynticEpithelium Oxyntic

Epithelium

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Concept 5-Progression of GERD

Medical Therapy for GERD

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Persistent Heartburn and Regurgitation with PPI

• Non-randomized Studies = 17% HB and 28% regurg

• Randomized Trails =

32% HB and 28% regurg

• Observational and Community-Based =

45% HB or regurg

PPIs Fail More Often Than Believed

• 1000 adults experiencing heartburn 1X/week• 79% nocturnal heartburn• 63% sleep difficulties• 34% sleep in chair• Effectiveness of medications for heartburn:• 29% for OTC• 49% for prescription Am J Gastroenterol 2003

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Prevalence of a Structurally Defective LES in GERD100%

80%

60%

40%

20%

0% Volunteersn=50

GERDNo Injury

n=67

GERDEsophagitis

n=42

GERDStricture

n=20

GERDBarrett’s

n=31

@ p <0.01 vs subjects without GERD;

* p <0.01 vs patients without injury and patients with other complication.

@

@

*

@

*

@

*

%StructurallyDefective

LES

Stein HJ et al.Ann Surg ,1991

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High Science in Medicine

Internet Driving Fear: Risks of PPIs

FDA: Possible Fracture Risk with High Dose, Long‐term Use of Proton Pump InhibitorsMay 25, 2010Labeling changes will include new safety  informationThe U.S. Food and Drug Administration today warned consumers and health care professionals about a possible increased risk of fractures of the hip, wrist, and spinewith high doses or long‐term use of a class of medications called proton pump inhibitors. The product labeling will be changed to describe this possible increased risk.

FDA: Possible Fracture Risk with High Dose, Long‐term Use of Proton Pump InhibitorsMay 25, 2010Labeling changes will include new safety  informationThe U.S. Food and Drug Administration today warned consumers and health care professionals about a possible increased risk of fractures of the hip, wrist, and spinewith high doses or long‐term use of a class of medications called proton pump inhibitors. The product labeling will be changed to describe this possible increased risk.

FDA: Possible Fracture Risk with High Dose, Long‐term Use of Proton Pump InhibitorsMay 25, 2010Labeling changes will include new safety  informationThe U.S. Food and Drug Administration today warned consumers and health care professionals about a possible increased risk of fractures of the hip, wrist, and spinewith high doses or long‐term use of a class of medications called proton pump inhibitors. The product labeling will be changed to describe this possible increased risk.

Acid‐Reducing Medicines May Lead toDependencyJuly 01, 2009Data suggests proton pump inhibitors can induce acid‐related symptoms in healthy adultsBethesda, MD (July 1, 2009) – Treatment with proton pump inhibitors (PPIs) for eight weeks induces acid‐related symptoms like heartburn, acid regurgitation anddyspepsia once treatment is withdrawn in healthy individuals, according to a new study in Gastroenterology, the official journal of the American GastroenterologicalAssociation (AGA) Institute.

Acid‐Reducing Medicines May Lead toDependencyJuly 01, 2009Data suggests proton pump inhibitors can induce acid‐related symptoms in healthy adultsBethesda, MD (July 1, 2009) – Treatment with proton pump inhibitors (PPIs) for eight weeks induces acid‐related symptoms like heartburn, acid regurgitation anddyspepsia once treatment is withdrawn in healthy individuals, according to a new study in Gastroenterology, the official journal of the American GastroenterologicalAssociation (AGA) Institute.

FDA Drug Safety Communication: Low magnesium levels can be associated with long‐term use of Proton Pump Inhibitor drugs (PPIs)March 2, 2011Safety Announcement The U.S. Food and Drug Administration (FDA) is informing the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (inmost cases, longer than one year). In approximately one‐quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.

RESEARCHARTICLEProton Pump Inhibitors are Associated with Focal ArrhythmiasDecember 2010Division of Cardiology, Electrophysiology Section, University of California, San Francisco, CAABSTRACT. Proton pump inhibitors (PPIs) are powerful H+/K+‐adenosine triphosphatase (ATPase) blockers commonly used to treat gastrointestinal illness. H+/K+‐ATPase ispresent in myocardial tissue, and PPIs may affect intracellular calcium. We sought to test the hypothesis that PPIs are proarrhythmic.

RESEARCHARTICLEProton Pump Inhibitors are Associated with Focal ArrhythmiasDecember 2010Division of Cardiology, Electrophysiology Section, University of California, San Francisco, CAABSTRACT. Proton pump inhibitors (PPIs) are powerful H+/K+‐adenosine triphosphatase (ATPase) blockers commonly used to treat gastrointestinal illness. H+/K+‐ATPase ispresent in myocardial tissue, and PPIs may affect intracellular calcium. We sought to test the hypothesis that PPIs are proarrhythmic.

FDA Drug Safety Communication: Clostridium difficile‐associated diarrhea can be associated with stomach acid drugsknown as proton pump inhibitors (PPIs)February 8, 2012Safety AnnouncementThe U.S. Food and Drug Administration (FDA) is informing the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile–associated diarrhea (CDAD). A diagnosis ofCDAD should be considered for patients taking PPIs who develop diarrhea that does not improve. Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve.

FDA Drug Safety Communication: Clostridium difficile‐associated diarrhea can be associated with stomach acid drugsknown as proton pump inhibitors (PPIs)February 8, 2012Safety AnnouncementThe U.S. Food and Drug Administration (FDA) is informing the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile–associated diarrhea (CDAD). A diagnosis ofCDAD should be considered for patients taking PPIs who develop diarrhea that does not improve. Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve.

FDA Drug Safety Communication: Clostridium difficile‐associated diarrhea can be associated with stomach acid drugsknown as proton pump inhibitors (PPIs)February 8, 2012Safety AnnouncementThe U.S. Food and Drug Administration (FDA) is informing the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile–associated diarrhea (CDAD). A diagnosis ofCDAD should be considered for patients taking PPIs who develop diarrhea that does not improve. Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve.

PPI Risks: Reality vs Fiction??

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Concept 6- Augmentation of the LES stops effacement

and reflux

Rise of The Nissen Fundoplication

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Mechanism of Anti-Reflux Operations• Creating a floppy valve with close

apposition between the abdominal esophagus and the gastric fundus

• Exaggeration of the flap valve at the angle of His

• Increase in the basal pressure generated by the lower esophageal sphincter

• Reduction in the triggering of TLES relaxations

• Reduction in the capacity of the gastric fundus speeding prox. and a total gastric emptying

• Prevention of effacement of the lower esophagus

Potential side-effects:

-Inability to belch, vomit, etc.

-Reversibility & Redo issues

-Reproducibility in community?

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AGA GERD Care Pathway

Surgeons Choose Not to Believe . . • Mortality (< 30 days) 1 %• Peri and immediate post operative morbidity 8-17 %• Open conversion rate 0-24 %• Early post operative complications

Bowel perforation 0-4 %Bleeding and splenic injury < 1 %Pneumothorax 0-10 %Severe nausea and vomiting 2-5 %

• Late postoperative complicationsGas bloat syndrome 1-85 %Temporary dysphagia 10-50 %Persistent dysphagia 3-24 %Diarrhea 18-33 %Recurrent heartburn 10-62 %

• Need for revisional surgeryLaparoscopic Nissen fundoplication 0-15 %Laparoscopic Toupet partial fundoplication 4-10 % Richter J.E. et al. Clin Gastroenterol Hepato 2012

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GERD Therapy in 2019

PATIENT CARE CONTINUUM

(20M

) PA

TIE

NT

PO

PUL

AT

ION

UnHappy Zone 20 million+ patients on PPI therapy for GERD in the US.

• Breakthrough Symptoms• Concern over long term use• Side Effects• Don’t want to take meds• Structural defect

60-70% 30-40%

Satisfied withMedical Therapy.

100%

Surgical Therapy

Endoscopic Therapies for GERD- Stretta Procedure

- EndoCinch Procedure

- Endoscopic Plication

- Esophyx/ TIF

- Enteryx Procedure

- Muse

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Can We Improve on the Classic Fundoplication

Magnetic Sphincter AugmentationMagnetic Cores provide pressure

(augmentation) of 15-25 mm-Hg

Interlinked Titanium beads allow dynamic

opening; resilience

“Roman Arch” design prevents compression of

esophagus

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Reflux Control after MSA

Ganz et al. (5 yr)

P<0.001 for comparison between baseline and all follow-ups

90%98%

3.6 13.5

74%

91%

5.617.9

0

20

40

60

80

100

120

PPI Elimination Symptom Improvement GERD HRQL Dysphagia

Improved Outcomes

HH Repair Minimal Dissection

MSA & HHSurg Endoscopy Aug 2016

p = 0.011p = 0.12

p = 0.027 p = 0.522

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Multi-Center Study HH>3cm

• 200 pts

– Mean HH size 5.5cm (3-10cm)

– 40% Esophagitis

– 20% Barrett’s

– Mean follow up 9 months

– Bioabsorbable Mesh 85%

• 94% PPI Elimination Rate

• GERD HRQL 26 to 5 Surg Endoscopy Sept 21, 2017

81

17

61

28

6 1 4 60

10

20

30

40

50

60

70

80

90

Daily PPI Use (%) RSI (Score) Regurgitation (%) Dysphagia (%)

Preoperatively Postoperatively

Multi-Center Study HH>3cm

• 200 pts

– Mean HH size 5.5cm (3-10cm)

– 40% Esophagitis

– 20% Barrett’s

– Mean follow up 9 months

– Bioabsorbable Mesh 85%

• 94% PPI Elimination Rate

• GERD HRQL 26 to 5 Surg Endoscopy Sept 21, 2017

81

17

61

28

6 1 4 60

10

20

30

40

50

60

70

80

90

Daily PPI Use (%) RSI (Score) Regurgitation (%) Dysphagia (%)

Preoperatively Postoperatively

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1. Objective Evidence of GERD

-Positive pH-Bx proven erosive esophagitis-Barrett’s

2. Esophageal Motility

-Soft/solid Barium Swallow-Manometry

3. Anatomy

-Hiatal hernia

Patient Selection

Operation Selection

Foregut Surgeon:Less Side Effects &

Complications

SurgerySurgerySurgery

Barrett’s EsophagusEarly Cancer

AblationAblationAblation

EMREMREMRHRMHRMHRM

pHpHpH

Comprehensive GERD Center of ExcellenceIf We Want to Impact this Disease

Bravo 48-96 hr24 hr Impendence pH

Endoscopy:NBI, CLE, VLE, Watts

CDx Brush, Etc

EndoscopyEndoscopyEndoscopy

Motility AssessmentHRM / EndoFlip

Achalasia, Scleroderma IEM, JackHammer, DES, Etc

Resection of NodulesTreatment & Staging

GERDCOE

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Best results are from high-volume centers!

• National Inpatient Sample 2002-2013

– 75,544 patients

– Low <10

– Intermediate 10-25

– High >25

• Length of Stay Longer

• Cost Higher 0

2

4

6

8

10

12

14

Esoph Perf Bleeding Cardiac Failure Resp Failure All Complications

% Complication Rate

Low Intermed High

We have a responsibility to self-regulate & know

our data

• National Inpatient Sample 2008-2012– 31,228 Pts

• Mortality Rate DOUBLE at Low Volume Hospitals

• Decrease for Every 10 Cases/yr over 10/yr

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Multidisciplinary Collaboration. Personalized Treatment Strategies. Patient Advocacy.

Opportunity-Position Foregut as a Specialty

• GI & Surgeon Partnership • Own The Disease• Centers of Excellence• Develop Algorithms for Tx

• Not Everyone Should get Surgery

• Not Everyone Should stay on Meds

• American Foregut Societyamericanforegutsociety.org