Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Research In Brief

This article was originally published in The Gray Sheet

Executive Summary

Is MTWA useful? Two new studies cast doubt on the potential for microvolt T-wave alternans (MTWA) testing to predict ventricular tachyarrhythmic events in heart failure patients. Results of a 490-patient substudy of Medtronic's Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) published in the journal Circulation found that MTWA testing did not predict arrhythmic events or mortality, suggesting that MTWA is "not useful as an aid in clinical decision making on implantable cardioverter defibrillator therapy among patients with heart failure and left-ventricular diastolic dysfunction," according to authors Michael Gold, Medical University of South Carolina, et al.. Results of the 575-patient Microvolt T Wave Alternans Testing for Risk Stratification of Post-Myocardial Infarction Patients (MASTER) trial, recently published in the Journal of the American College of Cardiology, found that the risk of ventricular tachyarrhythmia did not correlate to differences in MTWA test results in heart failure patients with an ICD that was implanted to prevent sudden cardiac death (1"The Gray Sheet" Nov. 12, 2007, p. 17). More studies needed: In an editorial accompanying the Gold study in Circulation, an expert on mechanisms of cardiac arrhythmias, David Rosenbaum, Case Western Reserve University in Cleveland, points out that the SCD-HeFT substudy suggests MTWA "does indeed track susceptibility to sudden cardiac death in a population where primary prevention strategies are highly relevant ... Further advances in risk stratification will also require trials where therapy is randomized on the basis of risk markets that reflect electrophysiological substrates for sudden cardiac death.

You may also be interested in...



GI Dynamics’ EndoBarrier

Firm gains CE mark approval of its EndoBarrier gastrointestinal liner device to treat obesity and type 2 diabetes. A sham-controlled pilot trial presented at the First World Congress on Interventional Therapies for Type 2 Diabetes in New York in September showed that EndoBarrier reduces average blood glucose levels in patients with type 2 diabetes (1"The Gray Sheet" Oct. 6, 2008, p. 22). Another recently published study shows EndoBarrier imitates the treatment effect of Roux-en-Y bypass surgery, including weight loss and improved metabolic function in rats with diet-induced obesity (2"The Gray Sheet" Nov. 24, 2008, p. 16). The company is planning to conduct larger, long-term trials in 2009

GI Dynamics’ EndoBarrier

Firm gains CE mark approval of its EndoBarrier gastrointestinal liner device to treat obesity and type 2 diabetes. A sham-controlled pilot trial presented at the First World Congress on Interventional Therapies for Type 2 Diabetes in New York in September showed that EndoBarrier reduces average blood glucose levels in patients with type 2 diabetes (1"The Gray Sheet" Oct. 6, 2008, p. 22). Another recently published study shows EndoBarrier imitates the treatment effect of Roux-en-Y bypass surgery, including weight loss and improved metabolic function in rats with diet-induced obesity (2"The Gray Sheet" Nov. 24, 2008, p. 16). The company is planning to conduct larger, long-term trials in 2009

Research In Brief

G.I. Liner: GI Dynamics' EndoBarrier gastrointestinal liner significantly reduces average blood glucose levels in patients with type 2 diabetes, according to results of a three-month, 18-patient, sham-controlled pilot study presented at the First World Congress on Interventional Therapies for Type 2 Diabetes in New York Sept. 16. The data, presented by Lee Kaplan, M.D./Ph.D, Harvard Medical School, show that the 12 patients treated with EndoBarrier in the trial experienced a mean reduction in average blood glucose of 2.9% from a baseline of 8.9%, compared to a reduction of 0.76% from a baseline of 9% in the six patients in the sham control group. EndoBarrier is an endoscopically implantable barrier that creates a duodenal-jejunal bypass to prevent food from contacting the intestinal wall. Investigators believe the bypass reduces a patient's uptake of both nutrients and calories and creates a similar metabolic effect as Roux-en-Y gastric bypass surgery, which has been shown to promote weight loss and resolution of type 2 diabetes. The firm plans to launch a major trial of an enhanced version of EndoBarrier in 2009

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

MT026830

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel