According to data published in Circulation Cardiovascular Quality and Outcomes, patients with atrial fibrillation 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 anti-arrhythmia drugs at one year.
On average, patients with AF 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.
The NaviStar ThermoCool Catheter (Biosense Webster) is the only ablation catheter approved by the FDA for the treatment of drug refractory recurrent symptomatic paroxysmal AF when used with Carto Navigation Systems. NaviStar ThermoCool Catheter and Carto Navigation System are CE marked since 1998 and 1994 respectively.
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 AF, compared to 16% of patients treated with medical therapy, also commonly referred to as anti-arrhythmic drugs (95% CI: 0.19, 0.47; p<0.001).
A sub-study analysis published on 17 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, nine 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, 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, USA. “These differences persisted for the duration of the trial and were strongly associated with recurrent arrhythmias, which were much more frequent in the anti-arrhythmic drug group. These results add to a growing body of literature demonstrating that catheter ablation improves quality of life more than anti-arrhythmic drugs in appropriately selected patients.”
“The results of this study provide important information for patients with AF and their physicians because it demonstrates that effective treatment of AF through an intervention like ablation can reduce the severity of their symptoms and improve the quality of their life,” said Reynolds.
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 AF.