Contact Force Sensing for Ablation of Paroxysmal Atrial Fibrillation
Study Questions:
Is the efficacy or safety of pulmonary vein isolation (PVI) affected by the use of a contact force (CF)-sensing ablation catheter in patients with paroxysmal atrial fibrillation (AF)?
Methods:
Two hundred ninety-five patients (mean age 60.3 years) with paroxysmal AF underwent radiofrequency catheter ablation for PVI. The patients were randomly assigned to the use of a CF-sensing irrigated-tip catheter (n = 152) or an irrigated-tip catheter without CF-sensing (n = 143). Re-do procedures or antiarrhythmic drug therapy were not allowed after a 3-month blanking period. Efficacy endpoints were acute PVI and freedom from atrial tachyarrhythmias at 12 months post-ablation. The study was powered to demonstrate noninferiority.
Results:
PVI was successfully achieved acutely in all patients. Clinical efficacy was achieved in a similar proportion of patients in the CF group (67.8%) and non-CF group (69.4%). The prevalence of device-related serious adverse events also was similar in the CF group (1.97%) and in the non-CF group (1.4%). Within the CF group, optimal CF (≥90% of ablations with ≥10 g) was associated with higher clinical efficacy compared to nonoptimal CF (75.9% vs. 58.1%).
Conclusions:
The safety and efficacy of a CF-sensing ablation catheter are noninferior to the safety and efficacy of a standard ablation catheter in patients with paroxysmal AF.
Perspective:
Lesion size resulting from radiofrequency ablation is highly dependent on CF. The reasonable expectation that real-time CF sensing improves the durability of PVI is not supported by the results of this study. A possible explanation is that operators are not always able to optimize CF when the CF is suboptimal.
Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias
Keywords: Arrhythmias, Cardiac, Atrial Fibrillation, Catheter Ablation, Catheters, Pulmonary Veins, Tachycardia, Supraventricular
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