Endoscopic vs Surgical Therapies for GERD · Structurally it is not significantly different from the rest of the esophagus, ... Dan Dunn, M.D ... Endoscopic vs Surgical Therapies

Endoscopic vs Surgical Therapies for GERD:

Is it Time to Put down the Scalpel?

Brian R. Smith, MD, FACS, FASMBS Associate Professor of Surgery &

General Surgery Residency Program Director UC Irvine Medical Center

Chief of Surgery VA Long Beach Healthcare System

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An effective treatment of GERD is expected to:

Relieve symptoms

Heal esophagitis (if present), and

Prevent chronic complications. 1-3

Depending on the stage of the disease, treatment consists of PPIs or antireflux surgery (or procedures). 2

GERD Treatments

1 Spicak. Dig Dis 2007;25:183-187. 2 Tytgat et al. Aliment Pharmacol Ther 2008;27:249-256. 3 Wolfe, Lowe. J Clin Gastroenterol 2007;41:S209-S216.

Endoscopic vs Surgical Therapies for GERD

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Lower Esophageal Sphincter (LES)

Angle of HIS

Fundus

Gastroesophageal Flap Valve (GEV)

Esophagus

Diaphragm

Z- Line

Grays Anatomy, 1997


Normal Anatomy Fully Functional Valve Prevents Reflux

Dysfunctional Valve Reflux

PresenterPresentation NotesA quick review of the gastro-esophageal anatomy previously new technologies for treating GERD focused on the LES. EGS believes that the GEV is the more important and powerful component of the anti-reflux barrier. There has been lots of misunderstanding of this anatomy, and a widespread understanding of the GEJ is just now coming to fruition. The group at Virginia Mason Medical Center in Seattle (where EGS founder, Stefan Kramer, worked with other thought leaders Drs Hill, Lowe, Kozarek, etc) were invited to rewrite the chapter on the GEJ in Grays Anatomy, because before 1997, Grays Anatomy did not even mention the GE flap valve! This shows the drawing of the anatomy that has been published in Grays Anatomy since 1997 based on Dr. Hill and Kraemers research. Interestingly, the lower esophageal sphincter (LES) is a bit of a misnomer, since it does not have a band of smooth muscle cells typical of most sphincters. Structurally it is not significantly different from the rest of the esophagus, and the increase in pressure at this site (LES high pressure zone) is likely an artifact of the presence of the diaphragm on the outside of the esophagus at this level. In cadavers, where there is no muscle tone, no reflux of the stomach contents is seen. This implies that something other than the LES is responsible for stopping reflux. The increase in pressure at the LES is also small, probably not enough to effectively cease all reflux.

Instead, EGS is focusing on the GE flap valve. Surgery (i.e. Nissen, Hill, Toupet) has shown that restoring the angle of His and recreating the flap valve effectively stops reflux. As you know, the angle at which the esophagus enters the stomach creates this flap valve that rests against the lesser curve of the stomach to close off the stomach from the esophagus. It was demonstrated by Dr. Hills work that when the stomach is distended or the GEJ stretches out, it causes the angle of His to flatten and opens the esophagus to the stomach contents. The positive intragastric pressure causes reflux of the stomach contents if the GEV is not present. As a result of overeating, ingestion of carbonated beverages and eating large quantities of food rapidly, the stomach is stretched, the angle of His is lost and the GEV is open. The EsophyX product was designed to correct the anatomical defect which in the past was corrected by performing a Fundoplication (typically a Nissen or Toupet is performed) either open or laparoscopically.

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Options Endo

Transoral incisionless fundoplication (TIF) Stretta MUSE

Surgical Lower esophageal magnetic augmentation (Linx) Fundoplication


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History of Endoluminal Treatment Options Suture RF Energy Injection

NDO Plicator

EndoCinch

Gatekeeper

EnteryX Stretta


PresenterPresentation NotesSrtetta bankrupt 11/06NDO bankrupt end of 07 beginning of 08

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40 - 60 minute procedure

12 SerosaFuse fasteners

(3.0 propylene sutures)

General anesthesia

Outpatient

Exclude Barretts, Class C/D esophagitis, HH > 2 cm

Transoral Incisionless Fundoplication

Pre-TIF Post-TIF


PresenterPresentation NotesReconstructs the primary barrier to reflux by creating a robust valve as part of the antireflux barrier, emulating natural anatomy

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TIF Outcomes Most prospective case series comparing pre-TIF to post-TIF Average follow-up ranges from 6 12 months Patients range from 8 -124 TEMPO Trial

RCT TIF vs PPI RESPECT Trial

RCT TIF vs Sham + PPI


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TEMPO US-based, multicenter (N=7), prospective, open label,

randomized comparative study TIF (39) vs double dose PPI (21) TIF improved ambulatory pH metrics, but was not better

than maximal dose PPI Normalization of esophageal acid exposure was not

achieved following TIF in all patients


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RESPECT Trial US-based, Multicenter (N=8), prospective TIF (87)

vs sham (42) randomized trial with 6 month f/u Excluded BMI > 35, HH > 2 cm, Class C/D

esophagitis

TIF effective in eliminating GERD symptoms, especially regurgitation, with a low failure rate and good safety profile at 6 months.


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TIF Summary Similar anti-reflux mechanism to Nissen fundoplication Generally tolerated well by patients Appears to have less short and long term side effects

than Nissen (less gas / bloating) Long term durability studies are lacking RCTs are ongoing Does not preclude performing Lap Nissen


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HOW STRETTA WORKS

Multi-level RF remodels LES and cardia Increased Wall thickness Decreased Tissue Compliance Increased LES Pressure Decreased TLESRs


45 minute procedure Outpatient Rapid recovery

Most are back to work/activities the following day

< 2cm HH

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STRETTA Efficacy META-Analysis - 18 Studies 1,441 Patients

Outcome Variable Studies (n)

Patients (n)

Mean Follow-up (mo)

Pre-Stretta Post-Stretta

P-value

SUBJECTIVE MEASUREMENTS

GERD-HRQL 9 433 19.8 26.11 9.25 0.0001

QOLRAD 4 250 25.2 3.30 9.25 0.0010

SF-36 Physical 6 299 9.5 36.45 46.12 0.0001

SF-36 Mental 5 264 10.0 46.79 55.16 0.0015

Heartburn Score 9 525 24.1 3.55 1.19 0.0001

Satisfaction Score 5 366 21.9 1..43 4.07 0.0006

OBJECTIVE MEASUREMENTS

Esophageal Acid Exposure (%Ph

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STRETTA Efficacy Sustained improvement in symptoms of GERD & antisecretory drug use: 4-year follow-up of the Stretta procedure. 96 PATIENTS - 48 MONTHS 75% OFF ALL MEDICATION NO SERIOUS COMPLICATIONS

Noar MD, Lotfi-Emran S. Gastrointest Endosc. 2007 Mar; 65(3): 367-72.

Long-term results of RF energy delivery for treatment of GERD: sustained improvements in symptoms, quality of life, & drug use at 4-year follow-up. 83 PATIENTS - 48 MONTHS 86.4% OFF DAILY MEDICATIONS NO SERIOUS COMPLICATIONS

Reymunde A, Santiago N. Gastrointest Endosc. 2007 Mar;65(3):361-6 Long-term results of RF energy delivery for treatment of GERD. Results of a 48 month prospective study. 56 PATIENTS - 48 MONTHS 72% OFF ALL MEDICATION 1 TRANSIENT COMPLICATION

Dughera et al, Diagnostic and Therapeutic Endoscopy, August 2011


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10 Year Stretta Efficacy Study

Noar et al. Surgical Endoscopy 2014 28: 2323-33


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Linx Standard Laparoscopic Approach Generally Completed in Less Than

1 Hour No Alteration to Gastric Anatomy Reversible No Post-Operative Adjustments


Small HH Normal motility No routine MRI No metal allergies

?? Larger HH, Barretts, prior

anti-reflux procedure, sleeve

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The NEW ENGLAND JOURNAL of MEDICINE

n engl j med 368;8 nejm.org, february 21, 2013 719

original article

Esophageal Sphincter Device for Gastroesophageal Reflux Disease

Robert A. Ganz, M.D., Jeffrey H. Peters, M.D., Santiago Horgan, M.D.,

Willem A. Bemelman, M.D., Ph.D., Christy M. Dunst, M.D., Steven A. Edmundowicz, M.D., John C. Lipham, M.D., James D. Luketich, M.D., W. Scott Melvin, M.D., Brant K. Oelschlager, M.D., Steven C.

Schlack-Haerer, M.D., C. Daniel Smith, M.D., Christopher C. Smith, M.D., Dan Dunn, M.D., and Paul A. Taiganides, M.D.

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Esophageal Acid Exposure

% T

ime

pH

< 4

(Mea

n) N=100

N=96

N=20

N=44

N=39 N=20

Chart1

BL Off PPIBL Off PPI

12 Month12 Month

24 Month24 Month

36 Month36 Month

Feasibility

Pivotal

11.9

11.6

3.1

5.1

2.3

3.8

Sheet1

BL Off PPI12 Month24 Month36 Month

Feasibility11.93.12.33.8

Pivotal11.65.1

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GE

RD

HR

QL

Sco

re O

ff P

PI (

Mea

n) N=44

N=37 N=33 N=39 N=35 N=31 N=23

N=98 N=98 N=95 N=90

N=100

Patient Quality of Life: GERD-HRQL Off PPIs

Chart1

BL Off PPIBL Off PPI

3 Month3 Month

6 Month6 Month

12 Month12 Month

24 Month24 Month

36 Month36 Month

48 Month48 Month

Feasibility

Pivotal

25.7

26.6

4.6

4.3

4.9

4.8

3.8

3.8

3.8

4.3

3

3.3

Sheet1

BL Off PPI3 Month6 Month12 Month24 Month36 Month48 Month

Feasibility25.74.64.93.83.833.3

Pivotal26.64.34.83.84.3

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Pat

ient

s R

epor

ting

Dai

ly P

PI U

se (%

)

Elimination of Daily PPIs

Chart1

BaselineBaseline

12 month12 month

24 month24 month

36 month36 month

48 month48 month

N=100

N=97

N=90

N=44

N=39

N=32

N=35

N=25

Feasiblity

Pivotal

100

100

10

9

20

8

16

20

Sheet1

Baseline12 month24 month36 month48 month

Feasiblity10010201620

Pivotal10098

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Pat

ient

s S

atis

fied

(%)

Patient Satisfaction

Chart1

BaselineBaseline

12 month12 month

24 month24 month

36 month36 month

48 month48 month

N=100

N=95

N=90

N=44

N=39

N=31

N=35

N=23

Feasiblity

Pivotal

0

0

87

95

80

90

88

87

Sheet1

Baseline12 month24 month36 month48 month

Feasiblity087808887

Pivotal09590

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Reduced Gas Bloat

Note: As actively queried by Foregut Questionnaire

Chart1

BaselineBaseline

12 Month Post LINX12 Month Post LINX

24 Month Post LINX24 Month Post LINX

FREQUENTLY

CONTINOUSLY

Percent of Patients Reporting

Severity of Gas Bloat

34

6

4.2

1.1

6.7

Sheet1

Baseline12 Month Post LINX24 Month Post LINX

FREQUENTLY344.26.7

CONTINOUSLY61.1

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What to Expect After Surgery Return to a normal diet as soon as tolerated Follow steps to manage dysphagia, if encountered Return to normal physical activity within a week Patients generally maintain ability to belch and vomit LINX Implant Card provided to all patients SIDE EFFECTS Ability to Belch

99% of patients retained ability to belch Inability to Vomit

0% at 12 months 1% at 24 months

Endoscopic vs Surgical Therapies for GERD Linx Summary

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Nissen Fundoplication Endoscopic vs Surgical Therapies for GERD

PresenterPresentation NotesIm talking to a room of surgeons so I dont have to tell you what a nissen fundoplication is

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The Best Fundoplication? 360o 270o posterior 180o posterior 180o anterior 120o anterior


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Outcomes of GERD/PEH Repair 90% improvement in reflux symptoms 87% absence of objective reflux 50% improvement from preoperative motility disorders

Excellent or good patient satisfaction in 92%

77% (Nissen) durability at 11 years in approp pts

Swanstrom LL, et al. Am J Surg 1999; 177:359-63

Pierre AF, et al. Ann Thorac Surg 2002; 74:1909-16

Morgenthal CB et al. Surg Endosc 2007


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Lap Nissen Fundoplication 1,000 cases Average hospital stay 1.2 days Resolution of symptoms at 1

year: 94% Major complications: 2% Long term complications: 2-62%

Gas and bloating Dysphagia

Hunter JG, et al. Surgical Endoscopy 2001


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Nissen vs Meds VA cooperative study/RCT Maximal meds vs surgery in medically refractory patients Results

2/3 resolved in surgical group at 12 months Less than 1/3 resolved in medical group

Conclusion: For PPI-refractory GERD, surgery is superior to meds

Spechler S, et al. In Press 2018


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Fundoplication

Post-procedure Pre-procedure


~ 75% durable at 10 years HH recurrence may

sabotage fundo In experienced hands,

gas/bloat uncommon Highly safe and effective

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Meds Endolumenal Surgery Esophageal Magnetic Augmentation


Slide Number 1Slide Number 2Slide Number 3OptionsHistory of Endoluminal Treatment OptionsSlide Number 6TIF OutcomesTEMPORESPECT TrialTIF SummarySlide Number 11STRETTA EfficacyMETA-Analysis - 18 Studies 1,441 PatientsSTRETTA Efficacy10 Year Stretta Efficacy StudyLinxThe NEW ENGLAND JOURNAL of MEDICINEEsophageal Acid ExposurePatient Quality of Life: GERD-HRQL Off PPIsElimination of Daily PPIsPatient SatisfactionReduced Gas BloatLinx SummaryNissen FundoplicationThe Best Fundoplication?Outcomes of GERD/PEH RepairLap Nissen FundoplicationNissen vs MedsFundoplicationSlide Number 29

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Endoscopic vs Surgical Therapies for GERD · Structurally it is not significantly different from the rest of the esophagus, ... Dan Dunn, M.D ... Endoscopic vs Surgical Therapies