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New England Journal of Medicine Study Shows Dramatically Reducing Pacing to Right Ventricle Cuts Risk of Persistent Atrial Fibrillation in Pacemaker Patients.


Treatment with Medtronic's Dual Chamber Minimal Ventricular Pacing Technologies Led to 40 Percent Reduction in Relative Risk Compared with Conventional Dual Chamber Pacing

MINNEAPOLIS -- Medtronic, Inc. (NYSE NYSE

See: New York Stock Exchange
:MDT MDT
abbr.
Mountain Daylight Time


MDT (in the US and Canada) Mountain Daylight Time

MDT n abbr (US) (= mountain daylight time) →
) today announced that reducing right ventricular pacing to less than 10 percent in patients with dual chamber pacemakers reduced the relative risk of developing persistent atrial fibrillation atrial fibrillation

Irregular rhythm (arrhythmia) of contraction of the atria (upper heart chambers). The most common major arrhythmia, it may result as a consequence of increased fibrous tissue in the aging heart, of heart disease, or in association with severe infection.
 (AF) by 40 percent compared with conventional dual chamber pacing in a trial of more than 1,000 patients with sinus node sinus node
n.
See sinoatrial node.


sinus node Sinoatrial node, see there, SA node
 disease. The trial, called SAVE PACe (The Search AV Extension and Managed Ventricular Pacing for Promoting Atrioventricular Conduction atrioventricular conduction
n.
Forward conduction of the cardiac impulse from the atria to ventricles via the atrioventricular node, represented in an electrocardiogram by the P-R interval.
) was funded by Medtronic and is published in this week's The New England Journal of Medicine The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world. .

The trial's objective was to demonstrate that dramatically reducing unnecessary right ventricular pacing can reduce the development of persistent atrial fibrillation. AF, an electrical malfunction of the upper chambers of the heart (atria Atria
The heart has four chambers. The right and left atria are at the top of the heart and receive returning blood from the veins. The right and left ventricles are at the bottom of the heart and act as the body's main pumps.
) that can lead to irregular heartbeats, is the most common side effect of pacemakers, and can cause stroke or death. Most Medtronic pacemakers available today, including the devices used in the trial, boast proprietary features called Managed Ventricular Pacing (MVP (Multimedia Video Processor) A high-speed DSP chip from Texas Instruments, introduced in 1994. Officially introduced as the TMS320C80, it combines RISC technology with the functionality of four DSPs on one chip. [TM]) or Search AV+[TM] that allow doctors to dramatically reduce unnecessary pacing to the right ventricle right ventricle
n.
The chamber on the right side of the heart that receives venous blood from the right atrium and forces it into the pulmonary artery.
 (lower chamber), which past studies have shown may lower the risk of developing AF and heart failure. SAVE PACe, the first prospective, randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 controlled study looking at the effect of reduced right ventricular pacing on AF, shows the benefits of Medtronic's technology in preventing the development of persistent AF.

"This is the first study to demonstrate a clear superiority of newer forms of dual chamber pacing for sinus node disease versus older pacemaker technology," said Dr. Michael O. Sweeney, of Brigham and Women's Hospital Brigham and Women's Hospital (BWH) is a hospital in the Longwood Area of the Boston, Massachusetts neighborhood of Mission Hill. With Massachusetts General Hospital, it is one of the two founding members of Partners HealthCare.  in Boston, who served as the trial's lead investigator. "Whereas previously some skepticism existed because of inherent uncertainties in retrospective analyses, I think the SAVE PACe trial will end that debate entirely, and hopefully, will redirect evidence-based guidelines for treatment of patients with sinus node disease toward aggressive reduction in potentially harmful right ventricular pacing."

After an average of 1.7 years in the study, 68 patients who received conventional dual chamber pacing developed persistent AF (12.7 percent), compared with 42 patients (7.9 percent) who received "dual chamber minimal ventricular pacing," which uses algorithms designed to minimize unnecessary pacing to the right ventricle of the heart. The study showed that patients in the treatment arm saw unnecessary right ventricular pacing reduced by greater than 90 percent. Mortality was similar in the two patient groups, but heart failure hospitalizations were greater than 50 percent lower for the patients who did not develop persistent AF (3.2 percent vs. 7.3 percent for those who did develop persistent AF). The trial was stopped early after an interim analysis revealed that patients not utilizing the algorithms designed to reduce right ventricular pacing showed a 1.8 times greater risk of developing persistent AF than those using the algorithms. This difference was highly statistically significant.

Unlike single chamber pacemakers, which control only the heart's right ventricle, dual chamber pacemakers deliver small electrical pacing pulses to both the right ventricle and the right atrium.

Scientists hypothesized that right ventricular apical apical /ap·i·cal/ (ap´i-k'l) pertaining to an apex.

a·pi·cal
adj.
1. Relating to the apex of a pyramidal or pointed structure.

2.
 stimulation during dual chamber pacing has adverse effects on left ventricular pump function, and retrospective analyses support this hypothesis by linking the frequency of right ventricular paced beats to increased risks of atrial fibrillation and heart failure in patients with sinus node disease.

Nearly all of Medtronic's currently manufactured dual chamber pacemakers feature either MVP or Search AV+ modes that provide the benefits of dual chamber pacing while limiting stimulation to the right ventricle to only when necessary. The MVP pacing mode pacing mode Cardiac pacing The manner in which a cardiac pacemaker provides artificial rate and rhythm support during arrhythmias; PMs are ID'd by the NBG Code. See NBG code. , in the Medtronic Adapta[TM] and EnRhythm[R] pacing systems, is designed to promote natural heart activity by dramatically reducing unnecessary right ventricular pacing, which is accomplished by automatically switching between single- and dual-chamber pacing based on specific patient needs. With the MVP mode, automatic switching between dual chamber pacing and single chamber atrial atrial /atri·al/ (a´tre-al) pertaining to an atrium.

a·tri·al
adj.
Of or relating to an atrium.


Atrial
Having to do with the upper chambers of the heart.
 pacing can reduce the amount of ventricular pacing to less than 5 percent, compared to 50 percent or more with typical dual-chamber pacing.

Search AV+, available in Medtronic Versa Versa Versatile System Architecture (Genrad) [TM], Sensia[TM] and EnPulse[R] pacing systems, senses the patient's natural heartbeats before delivering pacing therapy, which may reduce unnecessary electrical impulses in the ventricle ventricle /ven·tri·cle/ (ven´tri-k'l) a small cavity or chamber, as in the brain or heart.ventric´ular

ventricle of Arantius  the rhomboid fossa, especially its lower end.
 and allow the heart to beat on its own as often as possible.

"The results of the SAVE PACe trial highlight our ongoing commitment to innovation in the pacemaker market," said Pat Mackin, senior vice president and president of the Cardiac Rhythm Disease Management business at Medtronic. "We invested in the research and development of the proprietary MVP mode, and invested in the prospective, randomized SAVE PACe trial that provides the clinical evidence that Medtronic's new pacing strategies have a dramatic impact on patients by first reducing unnecessary pacing, which leads to a reduction in the development of persistent AF, and in turn has been proven to reduce heart failure hospitalizations. We are excited by the results of this study, which clinically prove that Medtronic's newer pacing products have a unique beneficial impact on the lives of patients with heart disease."

About SAVE PACe

SAVE PACe is a Medtronic-sponsored, randomized, controlled clinical trial controlled clinical trial,
n a research strategy that calls for two samples: an experimental sample of patients receiving a pharmaceutical, and a second sample of control patients receiving a placebo.
 to compare the strategy of dual chamber minimal ventricular pacing with conventional dual chamber pacing in patients with sinus node disease. The trial's objective was to demonstrate that dramatically reducing unnecessary right ventricular pacing can reduce the development of persistent atrial fibrillation. The study took place at 72 investigative centers in the U.S. and Canada, with 1,065 patients with bradycardia bradycardia: see arrhythmia.  (slow heartbeat) due to sinus node disease. All patients in the trial received Medtronic pacemakers equipped with either MVP or Search AV(+). The trial was stopped early by the Data Monitoring Committee after an interim analysis revealed that patients not utilizing the algorithms designed to minimize right ventricular pacing showed a 1.8 times greater risk of developing persistent AF than those using the algorithms. This difference was highly statistically significant. The study's authors found a 40 percent relative risk reduction for developing persistent AF among patients in the treatment arm.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 27, 2007. Actual results may differ materially from anticipated results.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved.

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Date:Sep 5, 2007
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