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Emerging Technology List
ENDOSCOPIC SUTURING SYSTEM
Canadian Coordinating
Office for Health
Technology Assessment
NO. 11
Technology:
Manufacturer:
Purpose:
JANUARY 2002
Endoscopic suturing system (endoluminal gastroplication) for gastroesophageal reflux.
C. R. Bard, Inc., Billerica, MA, U.S.
Treatment of gastroesophageal reflux disease (GERD).
Current Regulatory
Status:
The Bard® EndoCinch™ Suturing System received licensing approval from Health
Canada in 2001. A few centres in Ontario are already using the EndoCinch system and
several other Canadian centres will be using it in the near future (Gordon Blair, Bard
Canada, Mississauga (ON): personal communication, 2001 Dec 14). Marketing approval
for EndoCinch was granted by the U.S. Food and Drug Administration (FDA) in
March 2000.1
Description:
Gastroesophageal reflux disease, commonly known as severe heartburn, is a widespread,
chronic condition, with considerable variation in severity.2 The EndoCinch™ system has
recently been used to treat this condition. EndoCinch is a flexible endoscope with a
suturing device at one end. The endoscope is inserted down the patient's throat and
sutures are placed near the lower esophageal sphincter. The sutures are tied together to
create a pleat, which acts to prevent reflux from the stomach to the esophagus. The
procedure is performed on an outpatient basis and general anesthesia is usually not
required.
Cost:
Evidence of
Efficacy and Safety:
The manufacturer estimates the cost per procedure, in the U.S. with the EndoCinch
system is approximately US $3,000.3
A prospective, multi-centre, uncontrolled study on 64 patients suffering from GERD
showed improvement in heartburn severity and frequency as well as regurgitation at six
months follow-up (p > 0.0001 for each).4 The number of patients using proton pump
inhibitors (PPIs) or multiple medications daily decreased by 75%. While 61% of patients
(39/64) reported moderate to severe regurgitation at baseline, this decreased to 8% (4/51)
in the patients available for six months follow-up. Eleven of the 64 patients required a
repeat procedure to correct "suboptimal results" with the original suturing procedure.
Adverse effects included hypoxia (n=4), sore throat (n=20), chest pain (n=10),
abdominal pain (n=9), vomiting (n=9), mucosal tear (n=2), gastric bleeding (n=2) and
suture perforation (n=1). Most adverse effects were procedural rather than device related,
(none of the physicians in the trial had previously performed this procedure on humans).
According to the manufacturer's web site, 102 GERD patients treated with EndoCinch
in the U.K. showed an improvement in symptoms and a reduction in the use of proton
pump inhibitor drugs. Complications included minor hematemesis (vomiting of blood
because of internal bleeding) in two patients and transient difficulty in swallowing in
three patients. Longer-term follow-up suggested that most patients with good
improvement maintained that improvement after two to four years.5 Full details of the
study do not appear to have been published.
The Canadian Coordinating Office for Health Technology Assessment (CCOHTA)
is a non-profit organization funded by the federal, provincial and territorial governments. (www.ccohta.ca)
ENDOSCOPIC SUTURING SYSTEM
A study of 30 patients who underwent this procedure found a reduction of
approximately 66% in the use of anti-secretory medication in the patients who were
successfully treated. Heartburn resolved completely in 20/30 patients, resolved partially
in 4/30 and was unimproved in 6/30. If the results of this procedure are maintained,
long term cost savings in medications might offset the cost of the procedure within
several years.6
Available Alternative
Technologies:
Other technologies used to treat GERD include over-the-counter medications, lifestyle
changes (diet, cessation of smoking, etc.), H2 receptor antagonists, PPIs, and surgery
(open or laparoscopic fundoplication). Another new treatment for GERD, the Stretta
procedure, is considered in a separate CCOHTA Emerging Technology List no.12.7 One
study, of 20 patients, found the EndoCinch and Stretta procedures to be basically
equivalent in outcomes in short-term follow-up.8
Commentary:
Endoscopic suturing may be a promising alternative for the treatment of persons with
severe GERD. The potential benefits are a reduced use of medications and an avoidance
of major surgery. Appropriate patient selection is important.9 Patients may require retreatment after several years or as a result of procedural difficulties with the initial
suturing. A recent editorial makes several cautionary observations concerning this
technology.10 The author points out that the patients in the U.S. clinical trial appear to
have had less severe GERD. Obese patients, those with large hiatus hernia, and patients
with swallowing difficulties were excluded from the trial. Further studies are needed to
establish the long-term effectiveness of this technology, and to determine the costs, safety
and patient preferences for the EndoCinch treatment in comparison with other
therapies.
References:
1. Frequently asked questions about the EndoCinch suturing system. Billerica (MA): C. R. Bard,
Inc.; 2001. Available: http//heartburn-help.com/endocinch.htm (accessed 2001 May 22).
2. Fried GM. Laparoscopic antireflux surgery: what is enough? Can J Surg 2000;43(1):7-8.
3. Bard receives FDA clearance to market novel new device to treat chronic, severe heartburn
[press release]. 2000 Apr 5. Available: http://www.endocinch.com/news_detail.cfm?pressrelease
=2000%5F04%5F05%5F032625%5F154000pr%2Ecfm (accessed 2001 Dec 3).
4. Filipi CJ, Lehman GA, Rothstein RI, Raijman I, Stiegmann GV, Waring JP, et al. Transoral, flexible
endoscopic suturing for treatment of GERD: a multicenter trial. Gastrointest Endosc
2001;53(4):416-22.
5. Data shows the new BARD Endoscopic Suturing System effectively treats chronic heartburn,
reducing symptoms and reliance on medication [press release]. Murray Hill (NJ): C. R. Bard,
Inc.; 2000 May 24. Available: http://www.endocinch.com/news_detail.cfm?pressrelease
=2000%5F05%5F24%5F032210%5F397245pr%2Ecfm (accessed 2001 Dec 14).
6. Hodges D. New procedure eases pain, cost of GERD. Med Post 2001;37(38):24.
7. Hailey D, Topfer LA. Radiofrequency energy (the Stretta System) for gastroesophageal reflux
[Emerging technology list no 12]. Ottawa: Canadian Coordinating Office for Health Technology
Assessment; 2002. Available: http://www.ccohta.ca.
The Canadian Coordinating Office for Health Technology Assessment (CCOHTA)
is a non-profit organization funded by the federal, provincial and territorial governments. (www.ccohta.ca)
ENDOSCOPIC SUTURING SYSTEM
8. Pohl H, Wood KM, Rothstein RI. Endoscopic therapy for gastroesophageal reflux disease (GERD):
early experience with the Bard Endoscopic Suturing System (BESS) and Stretta in one institution
[abstract]. Dig Dis Week 2001;May 20-23. Available: http://www.dgs-endoskopi.dk/ddw2001/
reflux/stretta_3464.htm (accessed 2001 Nov 23).
9. Peters J. Pre-procedure testing - how important is it? Sandhill Sci Solution 2001;IV(1):3. Available:
http:/www.sandhillsci.com (accessed 2001 Dec 4).
10.Hogan WJ. Endoscopic treatment modalities for GERD: technologic score or scare? Gastrointest
Endosc 2001;53(4):541-5.
This summary was prepared by David Hailey, PhD and Leigh-Ann Topfer, MLS.
This series highlights medical technologies that are not yet in widespread use in Canada and that
may have a significant impact on health care. The contents are based on information from early
experience with the technology; however, further evidence may become available in the future.
These summaries are not intended to replace professional medical advice. They are compiled as an
information service for those involved in planning and providing health care in Canada.
ISSN 1499-108X (online only)
The Canadian Coordinating Office for Health Technology Assessment (CCOHTA)
is a non-profit organization funded by the federal, provincial and territorial governments. (www.ccohta.ca)