Endoluminal Gastroplication

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Endoluminal Gastroplication

• An endoscopic approach to GERD using the Bard
  EndoCinch Suturing System

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Background

• First system to permit suturing in GI track with
  flexible endoscope
• Device attaches onto standard upper GI endoscope

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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

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Where to Stitch??
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Squamocolumnar Junction
Z line
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Stitching Below the Z-line
Z line
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Scope advanced to LES

• Overtube placed
• Endoscope advanced
• Identify tissue to be sutured

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Vacuum applied tissue captured

• Vacuum applied
• Tissue captured

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Stitch placed

• Handle actuated
• Stitch placed through tissue bite
• Scope withdrawn and suture tag reloaded
• Scope reinserted
• Second stitch placed adjacent to first

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Knot Secured

• Switch to endoscope with suture anchoring device
• Load suture
• Advance to site

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Gastroplication formed

• Actuate handle to cinch and cut suture
• Gastroplication formed

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Pre-Procedure
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Post-Procedure
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Pre Post
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Bard EndoCinchInitial US Clinical Study

• Filipi et al, Gastrointest Endosc 2001

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Study Design

• Prospective, multi-center
• 64 patients with symptomatic GERD
• Patients randomized to two stitch configurations
• Post procedure visits at 1, 3, 6 months

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Study Criteria

• Inclusion Criteria
• Symptomatic GERD at least twice a week
• Dependant on H2Blockers or PPIs
• pH lt 4 for more than 4 time

• Exclusion Criteria
• Grade 3 or 4 esophagitis
• BMI gt 40
• Previous GE surgery
• GERD refractory to PPIs
• Hiatal Hernia gt 2cm length

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Results

• Procedure time avg. 68.6
• 46 patients - 2 plications
• 18 patients - 3 plications

• Conscious sedation - 69
• Monitored Anesthesia - 14
• General Anesthesia - 17

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Heartburn Symptom Score(Frequency x Severity)
62.7
plt.001
HBSS
16.7
17.0
20.8
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Patients Off MedicationsPPI/H2B lt 4 Doses/Month
(35/56)
(32/52)
Patients
(0/64)
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Medication Use

• Medication
• Multiple
• PPI Daily
• PPI Weekly
• H2 Blockers
• Antacids Daily
• Antacids Weekly
• None

• Baseline 3 Mo. 6 Mo.
• 7 0 0
• 44 13 12
• 0 5 5
• 6 5 3
• 1 6 5
• 0 17 18
• 0 12 13

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Regurgitation ScoreNone Mild
(52/56)
(47/51)
(54/64)
Patients
(25/64)
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Total Time pH lt 4
(n64)
(n53)
(n29)
Time pH lt4
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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

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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

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Bard EndoCinchRaijman, et. al. Multi-Center
Study

• Presented by Isaac Raijman, MD DDW 2001

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Study Design

• Prospective Multicenter study
• 88 patients with symptomatic GERD
• 3 stitch configurations
• Linear, circumferential, helical
• Average follow-up 9 months

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Summary

• Complete resolution of Heartburn 85
• Complete resolution of Regurgitation 90
• Discontinuation of medication 74

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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 lt3cms

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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

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European Clinical Experience (Park et. al.,
Sweden)

• Retrospective multicenter study
• 142 patients with symptomatic GERD
• 2 stitch configuration
• 12 week post procedure follow-up

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Summary

• Median LES length ? from 1.5 to 2.5cm
• Median pH time lt4 ? 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

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European Clinical Experience (Mahmood et. al.,
Ireland)

• Single center study
• 18 patients with symptomatic GERD
• 2 stitch configuration
• 3 month follow-up

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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

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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

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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

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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

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