Transcript presentation

Endoscopic Management of
GERD
Shinil K. Shah, DO
• Disclosures
– Medigus
– Neoclose
Introduction
• Growth of Esophageal Cancer
Introduction
• Growth of Use of Anti-Acid Medications
Introduction
• Negative Publicity of Anti-Acid Medications
Introduction
• GERD Disease Spectrum and Options for
Treatment
Endoluminal Therapy
Lifestyle Changes
Pharmaceuticals
Surgery
Introduction
• Society Position Statements
Introduction
• Endoluminal Options
TIF
EsophyX 2 ® HD Device
EsophyX® Z Device
TIF
• Fasteners are delivered with a squeeze and
release of the trigger, rather than with the older
stylet/pusher combination.
• The tissue mold is shrouded so the stylets do not
exit the mold.
• Counter rotation out of the corners may not be
required to deliver fasteners.
• Fastener trailing legs are presented to the
esophageal wall in a more prejudiced manner
that may increase the number of trailing legs that
deploy properly.
TIF
TIF Video
TIF Contraindications
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BMI > 35
Esophageal ulcer
Stricture
Barrett’s esophagus > 2 cm in length
Hiatal hernia > 2 cm
LA grade C or D esophagitis
Esophageal dysmotility
Previous esophageal or gastric surgery
Peptic ulcer disease
Gastric outlet obstruction
Gastroparesis
Pregnancy/plans for pregnancy in 12 months
Immunosuppression
Portal hypertension
Coagulopathy
TIF Studies
Jun-05
Cadière 2009
Jun-06
Jun-07
Jun-08
Jun-09
Jun-10
Jun-11
Jun-12
Jun-13
Jun-14
Cadière 2008 & Muls 2012
Repici 2010
Witteman 2012
Frazzoni 2011
1st Generation
Procedures
Demyttenaere 2010
Bergman 2008
Whitteman 2015
Hoppo 2010
2nd Generation
Procedures
Trad 2012
Nguyen 2011
Velanovich 2010
Barnes 2011
Bell 2011
Narsule 2012
Petersen 2012
Key
Enrollment
1st Publication
2nd Publication
3rd Publication
Ihde 2011
Rinsma 2013
US REGISTRY 2014
TEMPO 2014
RESPECT 2014
Randomized
Controlled Trials
3rd Generation
Procedures
TEMPO
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Multicenter, randomized, comparative study comparing TIF vs max dose PPI in
patients with partial response to PPI
7 study sites
6 month follow up
Primary hypothesis – TIF causes elimination of daily troublesome regurgitation or
extraesophageal GERD symptoms
Secondary hypothesis – patients who underwent TIF would have normalization of
esophageal acid exposure compared with baseline and be off PPIs
TEMPO
TEMPO
TEMPO
12 Month
TEMPO
12 Month
RESPECT
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Multicenter, randomized, comparative study comparing TIF vs PPI in patients with
troublesome regurgitation despite PPI
8 study sites
6 month follow up
Determine whether TIF was better than PPI in treatment of troublesome GERD
symptoms, particularly regurgitations, in patients on chronic PPI
RESPECT
Primary Outcome
• 58/67 (67%) of TIF/Placebo patients reported
elimination of troublesome regurgitation vs
19/42 (45%) of Sham/PPI patients (p=0.023)
RESPECT
TIF US Registry
TIF Long Term Outcomes
Study/
Parameter
Summary
Cadière
2009
Testoni
2011
Muls
2012
Witteman
2012
Bell/Registry
2014*
n
Follow-up
240
14
24 mos.
26
24 mos.
54
36 mos.
19
36 mos.
127
24 mos.
GERD-HRQL
Symptoms
64%-88%
improved
64%
≥ 50%
improvement
Significant
improvement
(46 to 18)
80%
≥ 50%
improvement
47% normalized
66%
≥ 50%
improvement
69%-79%
OFF DAILY
79%
(29/50)
69%
(42/27)
74%
(65/9)
76%
(42/32)
76%
(70/6)
Satisfaction
62%-86%
Satisfied
86%
Significant
improvement
(114 to 80)
70%
70%
62%
Durability
NS change from
3mo.-3yr.
NS change from
3mo.-2yr.
NS change from
6mo.-2yr.
NS change from
3mo.-3yr.
NS change from
6mo.-3yr.
NS change from
6mo.-2yr.
PPI Use
Off Daily
(% Off/Occasional)
*Data from US TIF 2.0 procedure technique
NS = not significant
TIF Reported Adverse Events
60
50
SAE rate of 0.413% (69 out of 16,700
Procedures)
As of 3/31/2015
40
30
20
12
11
11
8
10
8
6
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3
5
0
Distal
esophageal
perforation
Prox
esophageal
laceration or
perforation
Pleural
effusion
Tear
GEJ leak
GI Bleeding Mediastinitis /
Gastric
post - op
mediastinal
perforation
abcess
Other
MUSE
• Medigus Ultrasonic
Surgical Endostapler
– Flexible surgical
endostapler
– Uses video and ultrasound
guidance
– Creates anterior
fundoplasty using serial
firings of a quintuple of
staples (4.8 mm staples)
– Single use disposable
device
– Single operator procedure
MUSE
MUSE
MUSE
MUSE
MUSE
MUSE Video
MUSE Contraindications
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BMI < 21 or > 35
Esophageal stricture or varices
Failure to reduce hernia with PEEP
Hernia > 3 cm
Non responders to PPI therapy
Pilot Study
• 15 patients pilot study
• High dose PPI (2x standard
daily dosing)
• Follow up on 13 patients
Pilot Study
Pilot Study
• Adverse events noted
– One patient unable to undergo procedure (BMI 18, tissues too
thin)
– One patient cancelled because of complication during initial EGD
– One patient with urinary retention (65 year old man)
– One patient with duodenal ulcer at 6 weeks
– One patient with superficial thrombophlebitis at the site of IV
Pivotal Study
• Multi-center, 69 patients
• 6 month follow-up
• Primary endpoint - > 50% reduction in PPI dose and
reduction of total acid exposure on pH probe monitoring
• Follow up on 66 patients
• No sham control
• No “run in” procedures prior to start of study
Pivotal Study
Pivotal Study
Pivotal Study
Pivotal Study – Follow Up
• 37 patients from 3/6 pivotal study centers – 4 year follow up
Pivotal Study – Follow Up
Pivotal Study – Follow Up
STRETTA
Low power RF energy
delivered to tissue
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Multi-level treatment at muscle
depth improves muscle in the
LES and Gastric Cardia
Function improved, reduced
compliance, fewer TLESRs
“Stretta therapy remodels the musculature of the lower esophageal sphincter (LES) and
gastric cardia. Clinical studies demonstrate that the Stretta RF treatment results in
significant reductions in tissue compliance and transient LES relaxations. These
mechanisms act to restore the natural barrier function of the LES as well as to
significantly reduce spontaneous regurgitation caused by transient inappropriate
relaxations of the sphincter.”
Auyang ED et al., SAGES Guidelines Committee, Endoluminal Treatments for GERD, May 2013
STRETTA
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>15,000 patients
> 80 published studies
4 randomized trials
Multiple 4 year outcome studies
Follow up published at 8 and 10 years
3000+ patients studied in clinical trials
<1% adverse complication rate
Auyang ED et al., SAGES Guidelines Committee, Endoluminal Treatments for GERD, May 2013
STRETTA - Video
STRETTA
• SAGES
– Recommendation: STRONG
– Quality of Evidence (++++)
– …considered appropriate therapy for patients
being treated for GERD who are 18 years of age or
older, who have had symptoms of heartburn,
regurgitation, or both for 6 months or more, who
have been partially or completely responsive to
anti-secretory pharmacologic therapy, and who
have declined laparoscopic fundoplication.
Auyang ED et al., SAGES Guidelines Committee, Endoluminal Treatments for GERD, May 2013
STRETTA
• 20 studies, 2 RCTs
• Mean follow up 4 months to 53 months
• 1,441 total patients
STRETTA
STRETTA
• 4 randomized trials, 165 patients
• Pooled data reported no difference between
Stretta and sham or management with PPI
with regards to mean (%) time pH was <4 over
a 24 hour time course, LESP, ability to stop PPI,
or HRQOL
STRETTA
• Points of debate
– Low number of patients
– Criteria of effectiveness (normalization of pH < 4);
not achieved by PPIs or most endoluminal
therapies
– 2/3 studies that reported mean LES pressure
showed improvement with STRETTA
– 2/2 studies that evaluated HRQOL showed
improvements with STRETTA
STRETTA
• Points of debate
– Low number of patients
– Criteria of effectiveness (normalization of pH < 4);
not achieved by PPIs or most endoluminal
therapies
– 2/3 studies that reported mean LES pressure
showed improvement with STRETTA
– 2/2 studies that evaluated HRQOL showed
improvements with STRETTA
STRETTA
• Lipka et al reported significant adverse events
with STRETTA; there have been approximately
26 adverse events reported to the FDA out of
>15,000 procedures, resulting in overall
serious complication rate less than endoscopy
Descriptive Hiatal Endoscopy
• Axial displacement from
diaphragmatic pinch to eg
junction
• Diaphragmatic width:
greatest transverse
dimension (in cm) of the
hiatus
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Hill grade
– 1=no gap
– 2=intermittent gap
– 3=non closing gap
– 4=stomach always above
the diaphragm
Conclusions
• Patient selection is key
• PPI responders do best
• Appropriate diagnostic workup to confirm
diagnosis of reflux and rule out other “mimics”
• Consider pH probe and/or manometry in patients
with atypical symptoms or PPI non responders
• Anatomy is key, patients with larger Hiatal hernias
do not do well long term
Conclusions
• Appropriate expectations are extremely important
• Endoluminal therapies do not represent a cure for
reflux, rather an additional tool in the comprehensive
management of reflux patients
• Patients that do well initially appear to have sustained
outcomes
• Overall, extremely low risk of gas bloat and dysphagia
• Endoluminal therapies do not preclude formal
laparoscopic partial or complete fundoplication for
treatment failures
Conclusions
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Category 1 CPT Code
Jan 1, 2016
CPT 432XX1
Esophagogastric Fundoplasty Trans-Orifice
Procedures
Conclusions
• Therapy gap in treatment of patients with
GERD is being filled with endoluminal
treatments
• Additional studies are underway to determine
long term durability
• Product/procedure development continues