Patients With Common Heart Rhythm Disorder Demonstrated Improvements in Symptoms and Quality of Life With Catheter Ablation Compared to Treatment With Drug Therapy

November 22, 2010

WATERLOO, Belgium, November 22, 2010 /PRNewswire/ — 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 Dr.

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 services.

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.

SOURCE Biosense Webster, Inc.

Source: newswire

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