Patients With Common Heart Rhythm Disorder Demonstrated Improvements in Symptoms and Quality of Life With Catheter Ablation Compared to Treatment With Drug TherapyBy Biosense Webster Inc., PRNE
Sunday, November 21, 2010
WATERLOO, Belgium, November 22, 2010 - According to data published last week in Circulation
Cardiovascular Quality and Outcomes, patients with a common heart rhythm
disorder, called atrial fibrillation, who were treated with catheter ablation
using the NaviStar(R)ThermoCool(R) Catheter, reported markedly fewer symptoms
and substantially improved quality of life than patients treated with
antiarrhythmia drugs at one year.
Atrial fibrillation, or AFib as it is more commonly referred
to, is the most prevalent heart rhythm disorder, affecting an estimated 20
million people worldwide. It is also one of the most common causes of stroke
among people 65 years and older. On average, patients with AFib have
significantly reduced quality of life compared to the general population, and
their impairment may be similar to that of patients suffering from severe
chronic illnesses, such as kidney disease and heart failure.
During cardiac ablation, a catheter is inserted into the heart
and energy is delivered through the catheter to those areas of the heart
muscle causing the abnormal heart rhythm. This energy "disconnects" the
pathway of the abnormal rhythm. The NaviStar(R)ThermoCool(R) Catheter,
manufactured by Biosense Webster, Inc., is the only ablation catheter
approved by the U.S. Food and Drug Administration for the treatment of drug
refractory recurrent symptomatic paroxysmal AFib when used with Carto(R)
Navigation Systems.NaviStar(R)ThermoCool(R) Catheter and Carto(R) Navigation
System are CE marked since 1998 and 1994 respectively.
The primary study data published in JAMA in January 2010
demonstrated that at one year, 66% of patients treated with catheter ablation
remained free from documented symptomatic AFib, compared to 16% of patients
treated with medical therapy, also commonly referred to as anti-arrhythmic
drugs or AADs (95% CI: 0.19, 0.47; P< .001).
A sub-study analysis published on 17th November 2010 in
Circulation Cardiovascular Quality and Outcomes, demonstrates that quality of
life scores that were 10% - 20% below population norms, as measured by a
commonly used health survey called the Medical Outcomes Study Short Form-36
(SF-36), returned to population norms for patients treated with ablation, but
did not change with drugs. Additionally, symptom frequency and severity
scores, measured using the AF Symptom Checklist, decreased by greater than
50% in the ablation group, but were unchanged in the drug group.
"An in-depth analysis of the trial's data revealed that, for
the population studied, 9 of 10 specific measures of quality of life and
symptom burden - all except bodily pain - were superior in the group treated
with catheter ablation, compared to the drug group," said Matthew Reynolds,
MD, MSc, primary investigator for the sub-study and lead author, and Medical
Director of the Economics and Quality of Life Assessment Group at the Harvard
Clinical Research Institute in Boston. "These differences persisted for the
duration of the trial and were strongly associated with recurrent
arrhythmias, which were much more frequent in the antiarrhythmic drug group.
These results add to a growing body of literature demonstrating that catheter
ablation improves quality of life more than antiarrhythmic drugs in
appropriately selected patients."
AFib: Growing Statistics and Current Treatment Options
AFib is the most prevalent heart rhythm disorder, yet only an
estimated 110,000 patients per year are treated with ablation. Most patients
with AFib today are treated with AADs even though in about half of them, the
drugs do not control the AFib symptoms.
"The results of this study provide important information for
patients with AFib and their physicians because it demonstrates that
effective treatment of AFib through an intervention like ablation can reduce
the severity of their symptoms and improve the quality of their life," said
In 2006, the leading medical societies including the American
Heart Association, American College of Cardiology and the European Society of
Cardiology recommended catheter ablation as second-line therapy for AFib.
In addition to his role as the primary investigator for this
sub-study analysis, Dr. Reynolds is compensated for his services as a member
of the company's health policy advisory board and provides other consulting
About Biosense Webster, Inc.
Biosense Webster, Inc., a Johnson & Johnson company, pioneered
electrophysiology diagnostic catheters more than 30 years ago and continues
to lead the industry as an innovative provider of advanced diagnostic,
therapeutic and mapping tools. As the leader in navigation systems and
ablation therapy, Biosense Webster, Inc.'s technology includes the largest
installed base of navigation systems worldwide in leading hospitals and
teaching institutions. With its proprietary products the company is changing
the way electrophysiologists diagnose and treat arrhythmias. Biosense
Webster, a Division of Johnson & Johnson Medical SA, Waterloo, Belgium, is
the European authorized representative of Biosense Webster, Inc.
Joanne Bullen, APCO Worldwide, +44(0)207526 3652, +44(0)7971-498078-83
Tags: belgium, Biosense Webster Inc., November 22, Waterloo