  
Novel device combines pacemaker with implanted defibrillator
Last Updated: 2001-05-02 19:00:35 EDT (Reuters Health)
By Steven Reinberg
WESTPORT, CT (Reuters Health) - The new Contak CD/Easytrak system, which combines cardiac resynchronization therapy with an implantable cardioverter defibrillator, slows the progression of heart failure and helps prevent sudden cardiac death, Guidant Corporation of Indianapolis reported Wednesday at the 22nd Annual Scientific Sessions of the North American Society of Pacing and Electrophysiology in Boston.
"The Contak CD trial is the largest trial to date that looks at patients with heart failure treated with cardiac resynchronization therapy," researcher Dr. Paul Ludmer, from the San Francisco East Bay Arrhythmia and Electrophysiology Center, told Reuters Health.
"Among 490 patients, with NYHA class III, IV and II heart failure, in the randomized Contak CD trial there was a very strong trend toward a reduction in the heart failure index. We not only saw a reduction in the progression of the disease, but we saw an improvement in left ventricular remodeling," he added.
The Contak CD/EasyTrak is similar to a standard pacemaker defibrillator, with leads in the right atrium and right ventricle, but there is also a lead in the coronary sinus. "This allows us to pace the main pumping chamber of the heart and to synchronize the contractility between the ventricles," Dr. Ludmer explained.
Because the system combines a pacemaker with an implantable defibrillator, it can be used both to treat heart failure and to prevent sudden cardiac death. "In our heart failure patients 30% to 50% die suddenly, so if we only improve their functional capacity with cardiac resynchronization therapy we are only solving part of the problem," Dr. Ludmer stressed. "We also have to solve the problem of sudden cardiac death."
The trial results demonstrated that mortality among the treated patients was reduced by 23%, heart failure hospitalization by 13%, worsening heart failure that required an emergency room visit or intravenous medication by 26%, and episodes of ventricular tachycardia or ventricular fibrillation by 9%, according to Dr. Ludmer.
He noted that in both the treatment and control groups the defibrillators were turned on, and 63 of the 490 patients required defibrillator treatment for ventricular tachycardia within the 4.5 months of the trial. "Annually, that means that 25% of these patients would need defibrillator treatment," he noted.
"I have been impressed with the dramatic improvement that my patients have had," Dr. Ludmer said. "Going into the trial most of the patients were NYHA class III or IV, and by the end of the trial 80% of the patients were NYHA class I or II."
Guidant Corporation said that it submitted a premarket application to the US Food and Drug Administration in February and anticipates marketing clearance later this year.
-Westport Newsroom 203 319 2700
|
Copyright 2001 Reuters Limited. All rights reserved. Republication or redistribution of Reuters Limited content, including by framing or similar means, is expressly prohibited without prior written consent of Reuters Limited. Reuters Limited shall not be liable for any error or delays in the content, or for any actions taken in reliance thereon.
|
|
 Back To Fertility Wellness Center
| 
