endoscopic vs surgical therapies for gerd · 2018. 1. 30. · discover teach heal • an effective...
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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
Gray’s Anatomy, 1997
Endoscopic vs Surgical Therapies for GERD
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 Gray’s Anatomy since 1997 based on Dr. Hill and Kraemer’s 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. Hill’s 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
Endoscopic vs Surgical Therapies for GERD
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History of Endoluminal Treatment Options Suture RF Energy Injection
NDO Plicator
EndoCinch
Gatekeeper
EnteryX Stretta
Endoscopic vs Surgical Therapies for GERD
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 Barrett’s, Class C/D esophagitis, HH > 2 cm
Transoral Incisionless Fundoplication
Pre-TIF Post-TIF
Endoscopic vs Surgical Therapies for GERD
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
Endoscopic vs Surgical Therapies for GERD
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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
Endoscopic vs Surgical Therapies for GERD
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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.
Endoscopic vs Surgical Therapies for GERD
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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
Endoscopic vs Surgical Therapies for GERD
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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
Endoscopic vs Surgical Therapies for GERD
• 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
Endoscopic vs Surgical Therapies for GERD
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10 Year Stretta Efficacy Study
Noar et al. Surgical Endoscopy 2014 28: 2323-33
Endoscopic vs Surgical Therapies for GERD
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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
Endoscopic vs Surgical Therapies for GERD
• Small HH • Normal motility • No routine MRI • No metal allergies
• ?? • Larger HH, Barrett’s, 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 PPI’s
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 NotesI’m talking to a room of surgeons so I don’t 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
Endoscopic vs Surgical Therapies for GERD
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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
Endoscopic vs Surgical Therapies for GERD
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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
Endoscopic vs Surgical Therapies for GERD
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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
Endoscopic vs Surgical Therapies for GERD
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Fundoplication
Post-procedure Pre-procedure
Endoscopic vs Surgical Therapies for GERD
• ~ 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
Endoscopic vs Surgical Therapies for GERD
Slide Number 1Slide Number 2Slide Number 3OptionsHistory of Endoluminal Treatment OptionsSlide Number 6TIF OutcomesTEMPORESPECT TrialTIF SummarySlide Number 11STRETTA Efficacy�META-Analysis - 18 Studies – 1,441 PatientsSTRETTA Efficacy10 Year Stretta Efficacy Study��Linx®The NEW ENGLAND �JOURNAL of MEDICINEEsophageal Acid ExposurePatient Quality of Life: GERD-HRQL Off PPI’sElimination of Daily PPIs�Patient Satisfaction�Reduced Gas BloatLinx SummaryNissen FundoplicationThe Best Fundoplication?Outcomes of GERD/PEH RepairLap Nissen FundoplicationNissen vs MedsFundoplicationSlide Number 29