Jan 27 2010
According to data appearing today in JAMA,
patients with a common heart rhythm disorder, called Atrial
Fibrillation, who were treated with catheter ablation using the NAVISTAR®
THERMOCOOL® Catheter, demonstrated significantly better
outcomes at one year compared to those receiving drug therapy. In
addition, the patients treated with catheter ablation reported markedly
fewer symptoms and substantially improved quality of life.
“The likelihood of
AFib recurrence within 6-12 months approaches 50% with most drugs, and
AADs are also associated with cumulative adverse effects over time.”
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. The NAVISTAR® THERMOCOOL®
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®
Navigation Systems.
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.
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). In
addition, quality of life scores improved significantly in patients
treated with ablation at three months, and this improvement was
maintained at one year. According to this study, ablation treatment,
which restores and maintains normal sinus rhythm, was associated with
improved quality of life.
“Though anti-arrhythmic drugs are generally used as first-line therapy
to treat AFib, a number of clinical trials, including this one, have
demonstrated that their effectiveness remains inconsistent,” said David
Wilber, M.D., Primary Investigator and Lead Author of the study and the
George M. Eisenberg Professor of Cardiovascular Sciences and Director,
Division of Cardiology, Loyola
University Medical Center in Maywood, Illinois. “The likelihood of
AFib recurrence within 6-12 months approaches 50% with most drugs, and
AADs are also associated with cumulative adverse effects over time.”
This clinical trial was a randomized, controlled trial of symptomatic,
paroxysmal AFib patients whose symptoms were not controlled on at least
one AAD and had at least three episodes of AFib in the six months prior
to joining the trial. A total of 167 patients were enrolled from 19
sites throughout the world. The primary effectiveness endpoint was
freedom from documented symptomatic AFib recurrence following the
confirmation of the ablation procedure endpoint and absent new AAD use
or a repeat ablation procedure outside of protocol-defined criteria.
The NAVISTAR®
THERMOCOOL® Catheter ablation group also demonstrated an
excellent safety profile with no device-related serious adverse events
such as death, heart attack, stroke, cerebrovascular accident,
heart block or atrial perforation within seven days post ablation.
Importantly, the incidence of treatment related adverse events measured
at 30 days in the THERMOCOOL® Catheter ablation group was
observed to be approximately half that in the AAD group (5% vs. 9%) and
there was no clinically significant pulmonary vein stenosis in patients
receiving ablation.
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 AFib represents an important
public health problem, including an increased long-term risk of stroke,
heart failure, and all cause mortality,” said Dr. Wilber.
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.
SOURCE Biosense
Webster, Inc.,
Ablation may offer better outcomes than medication for ventricular tachycardia