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EndoCinch Physician Slide Series

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Endoluminal Gastroplication
An endoscopic approach to GERD
using the BardВ® EndoCinchв„ў
Suturing System
Background
пЃєFirst system to permit
suturing in GI track
with flexible
endoscope
пЃєDevice attaches onto
standard upper GI
endoscope
Procedure
пЃєSutures are placed at lower esophageal
sphincter
пЃ№2 locations
пЃ№Tied together to create a pleat (plication)
пЃєHas been shown to significantly improve
symptoms & regurgitation and reduce or
eliminate medications
Where to Stitch??
Squamocolumnar Junction
Z line
Stitching Below the Z-line
Z line
Scope advanced to LES
пЃєOvertube placed
пЃєEndoscope advanced
пЃєIdentify tissue to be
sutured
Vacuum applied & tissue captured
пЃєVacuum applied
пЃєTissue captured
Stitch placed
пЃєHandle actuated
пЃєStitch placed through
tissue bite
пЃєScope withdrawn and
suture tag reloaded
пЃєScope reinserted
пЃєSecond stitch placed
adjacent to first
Knot Secured
пЃєSwitch to endoscope
with suture anchoring
device
пЃєLoad suture
пЃєAdvance to site
Gastroplication formed
пЃєActuate handle to cinch
and cut suture
пЃєGastroplication formed
Pre-Procedure
Post-Procedure
Pre
Post
Bard EndoCinch
Initial US Clinical Study
Filipi et al, Gastrointest Endosc 2001
Study Design
пЃєProspective, multi-center
пЃє64 patients with symptomatic GERD
пЃєPatients randomized to two stitch
configurations
пЃєPost procedure visits at 1, 3, 6 months
Study Criteria
Inclusion Criteria:
пЃєSymptomatic GERD at
least twice a week
пЃєDependant on
H2Blockers or PPI’s
пЃєpH < 4 for more than
4% time
Exclusion Criteria:
пЃєGrade 3 or 4 esophagitis
пЃєBMI > 40
пЃєPrevious GE surgery
GERD refractory to PPI’s
пЃєHiatal Hernia > 2cm
length
Results
пЃє Procedure time: avg. 68.6
пЃє Conscious sedation - 69%
пЃє 46 patients - 2 plications
пЃє Monitored Anesthesia - 14%
пЃє 18 patients - 3 plications
пЃє General Anesthesia - 17%
Heartburn Symptom Score
(Frequency x Severity)
100
80
62.7
60
p<.001
40
20.8
16.7
1 Mo.
3 Mo.
17.0
20
0
Baseline
6 Mo.
Patients Off Medications
PPI/H2B < 4 Doses/Month
80%
62% (35/56)
60%
62%
(32/52)
40%
20%
0% (0/64)
0%
Baseline
3 Mo.
6 Mo.
Medication Use
Medication
Baseline
Multiple
7
PPI Daily
44
PPI Weekly
0
H2 Blockers
6
Antacids Daily
1
Antacids Weekly
0
None
0
3 Mo.
0
13
5
5
6
17
12
6 Mo.
0
12
5
3
5
18
13
Regurgitation Score
None & Mild
94%
100%
86%
% Patients
(52/56)
(54/64)
75%
50%
92%
(47/51)
39%
(25/64)
25%
0%
Baseline
1 Mo.
3 Mo.
6 Mo.
% Total Time pH < 4
12
10
8
9.6
9.3
8.5
(n=64)
(n=53)
(n=29)
Baseline
3 Mo.
6 Mo.
6
4
2
0
Baseline
3 Mo.
6 Mo.
Safety Summary
Most Common Complaints:
пЃ№Sore Throat
14
пЃ№Vomiting
8
пЃ№Abdominal Pain
7
Serious Adverse Events:
пЃ№Desaturation
4
пЃ№Esoph. mucosal laceration
2
пЃ№Self contained suture perf
1
Summary
пЃєDevice is safe & effective
пЃє73% improvement in HBSS
пЃє75% reduction in multiple meds or daily PPIs
пЃє90% patients have no or mild regurgitation
пЃє87% patients experienced an improvement or
maintenance of esophagitis
пЃєNo significant effect on pH and manometry
пЃєSignificant decrease in number of reflux episodes
Bard EndoCinch
Raijman, et. al.
Multi-Center Study
Presented by Isaac Raijman, MD DDW
2001
Study Design
пЃєProspective Multicenter study
пЃє88 patients with symptomatic GERD
пЃє3 stitch configurations
пЃ№Linear, circumferential, helical
пЃєAverage follow-up: 9 months
Summary
пЃєComplete resolution of Heartburn: 85%
пЃєComplete resolution of Regurgitation: 90%
пЃєDiscontinuation of medication: 74%
Comparative Summary
пЃє2 plications: 91% with favorable results
пЃє3 plications: 88% with favorable results
пЃєLarge hiatal hernia (3-4 cm) had similar
response to those with hernias <3cms
Summary
пЃєThe results of this study compare
favorably to those from the previously
reported multi-center trial
пЃєThe practice of ELGP should continue
including patients with apparent less
favorable clinical parameters
European Clinical Experience
(Park et. al., Sweden)
пЃєRetrospective multicenter study
пЃє142 patients with symptomatic GERD
пЃє2 stitch configuration
пЃє12 week post procedure follow-up
Summary
пЃєMedian LES length пѓ© from 1.5 to 2.5cm
пЃєMedian pH time <4 пѓЄ from 8.4 to 3.9
пЃєFollow up suggest that good
improvements maintain at least 2-4 years
and that the stitches will stay intact
European Clinical Experience
(Mahmood et. al., Ireland)
пЃєSingle center study
пЃє18 patients with symptomatic GERD
пЃє2 stitch configuration
пЃє3 month follow-up
Summary
пЃєHeartburn frequency пѓЄ from 79% to
27%
пЃєHeartburn severity пѓЄ from 72% to 24%
пЃєRegurgitation пѓЄ from 64% to 18%
пЃєPPIs/H2Rs use пѓЄ 80%
пЃєMean pH DeMeester пѓЄ from 42 to 25
Additional Studies Ongoing
ACG �01 - 2 yr follow-up, cost effectiveness
пЃєWorld Congress - long term multi-center
DDW �02 - various studies including: multi-center,
cost effectiveness, pH follow-up, mechanism of
action studies
пЃєSham Controlled in-process
Endosuturing Training
пЃєPhysicians and assistants attend workshop
пЃєReview literature
пЃєReview patient selection and management
пЃєHands-on sessions
пЃєClinical Field Trainers observe early cases for
support
Post Launch Results (9/01)
пЃє2000+ patients treated worldwide
пЃє1500+ patients treated in US since launch
пЃєHigh safety profile
пЃєProcedure continues to have good results
пЃєLong term studies ongoing
Q&A
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