According to data appearing today in Circulation Cardiovascular Quality
and Outcomes, patients with a common heart rhythm disorder, called atrialfibrillation, who were treated with
catheter ablation using the NAVISTAR®
THERMOCOOL® 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 as compared to the general
population, and their impairment may be similar to patients suffering
from severe chronic illnesses, such as kidney disease and heart failure.
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®
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®
The primary study data published in JAMA in January, 2010 demonstrated
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).
This sub-study analysis published today 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
AFib: Growing Statistics and Current Treatment
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.
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 proprietary products
such as the CARTO® 3 System, the CARTOSOUND® Image
Integration Software Module, the THERMOCOOL® Irrigated Tip
Catheter and the LASSO® Circular Variable Mapping Catheter,
the company is changing the way electrophysiologists diagnose and treat
For more information about Biosense Webster, visit www.biosensewebster.com.
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Wednesday, September 21, 2011
Marriott Marquis, New York
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