Transcript EndoCinch Physician Slide Series

Endoluminal Gastroplication
An endoscopic approach to GERD
using the Bard® EndoCinch™
Suturing System
Background
First system to permit
suturing in GI track
with flexible
endoscope
Device attaches onto
standard upper GI
endoscope
Procedure
Sutures are placed at lower esophageal
sphincter
2 locations
Tied together to create a pleat (plication)
Has 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
Overtube placed
Endoscope advanced
Identify tissue to be
sutured
Vacuum applied & tissue captured
Vacuum applied
Tissue captured
Stitch placed
Handle actuated
Stitch placed through
tissue bite
Scope withdrawn and
suture tag reloaded
Scope reinserted
Second stitch placed
adjacent to first
Knot Secured
Switch to endoscope
with suture anchoring
device
Load suture
Advance to site
Gastroplication formed
Actuate handle to cinch
and cut suture
Gastroplication formed
Pre-Procedure
Post-Procedure
Pre
Post
Bard EndoCinch
Initial US Clinical Study
Filipi et al, Gastrointest Endosc 2001
Study Design
Prospective, multi-center
64 patients with symptomatic GERD
Patients randomized to two stitch
configurations
Post procedure visits at 1, 3, 6 months
Study Criteria
Inclusion Criteria:
Symptomatic GERD at
least twice a week
Dependant on
H2Blockers or PPI’s
pH < 4 for more than
4% time
Exclusion Criteria:
Grade 3 or 4 esophagitis
BMI > 40
Previous GE surgery
GERD refractory to PPI’s
Hiatal Hernia > 2cm
length
Results
 Procedure time: avg. 68.6
 Conscious sedation - 69%
 46 patients - 2 plications
 Monitored Anesthesia - 14%
 18 patients - 3 plications
 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:
Sore Throat
14
Vomiting
8
Abdominal Pain
7
Serious Adverse Events:
Desaturation
4
Esoph. mucosal laceration
2
Self contained suture perf
1
Summary
Device is safe & effective
73% improvement in HBSS
75% reduction in multiple meds or daily PPIs
90% patients have no or mild regurgitation
87% patients experienced an improvement or
maintenance of esophagitis
No significant effect on pH and manometry
Significant decrease in number of reflux episodes
Bard EndoCinch
Raijman, et. al.
Multi-Center Study
Presented by Isaac Raijman, MD DDW
2001
Study Design
Prospective Multicenter study
88 patients with symptomatic GERD
3 stitch configurations
Linear, circumferential, helical
Average follow-up: 9 months
Summary
Complete resolution of Heartburn: 85%
Complete resolution of Regurgitation: 90%
Discontinuation of medication: 74%
Comparative Summary
2 plications: 91% with favorable results
3 plications: 88% with favorable results
Large hiatal hernia (3-4 cm) had similar
response to those with hernias <3cms
Summary
The results of this study compare
favorably to those from the previously
reported multi-center trial
The practice of ELGP should continue
including patients with apparent less
favorable clinical parameters
European Clinical Experience
(Park et. al., Sweden)
Retrospective multicenter study
142 patients with symptomatic GERD
2 stitch configuration
12 week post procedure follow-up
Summary
Median LES length  from 1.5 to 2.5cm
Median pH time <4  from 8.4 to 3.9
Follow 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)
Single center study
18 patients with symptomatic GERD
2 stitch configuration
3 month follow-up
Summary
Heartburn frequency  from 79% to
27%
Heartburn severity  from 72% to 24%
Regurgitation  from 64% to 18%
PPIs/H2Rs use  80%
Mean pH DeMeester  from 42 to 25
Additional Studies Ongoing
ACG ‘01 - 2 yr follow-up, cost effectiveness
World Congress - long term multi-center
DDW ‘02 - various studies including: multi-center,
cost effectiveness, pH follow-up, mechanism of
action studies
Sham Controlled in-process
Endosuturing Training
Physicians and assistants attend workshop
Review literature
Review patient selection and management
Hands-on sessions
Clinical Field Trainers observe early cases for
support
Post Launch Results (9/01)
2000+ patients treated worldwide
1500+ patients treated in US since launch
High safety profile
Procedure continues to have good results
Long term studies ongoing
Q&A