Abstract
PurposeThe prospective, multicenter SMART SF trial demonstrated the acute safety and effectiveness of the 56-hole porous tip irrigated contact force (CF) catheter for drug-refractory paroxysmal atrial fibrillation (PAF) ablation with a low primary adverse event rate (2.5%), leading to FDA approval of the catheter. Here, we are reporting the long-term effectiveness and safety results that have not yet been reported.MethodsAblations were performed using the 56-hole porous tip irrigated CF catheter guided by the 3D mapping system stability module. The primary effectiveness endpoint was freedom from atrial tachyarrhythmia (including atrial fibrillation, atrial tachycardia, and/or atrial flutter), based on electrocardiographic data at 12 months. Atrial tachyarrhythmia recurrence occurring 3 months post procedure, acute procedural failures such as lack of entrance block confirmation of all PVs, and undergoing repeat procedure for atrial fibrillation in the evaluation period (91 to 365 days post the initial ablation procedure) were considered to be effectiveness failures.ResultsSeventy-eight patients (age 64.8 ± 9.7 years; male 52.6%; Caucasian 96.2%) participated in the 12-month effectiveness evaluation. Mean follow-up time was 373.5 ± 45.4 days. The Kaplan-Meier estimate of freedom from 12-month atrial tachyarrhythmia was 74.9%. Two procedure-related pericardial effusion events were reported at 92 and 180 days post procedure. There were no pulmonary vein stenosis complications or deaths reported through the 12-month follow-up period.ConclusionsThe SMART SF 12-month follow-up evaluation corroborates the early safety and effectiveness success previously reported for PAF ablation with STSF.
Highlights
Atrial fibrillation (AF) is the most common arrhythmia diagnosed in clinical practice and the prevalence is increasing as the US population ages [1, 2]
To be included in the effectiveness evaluation, subjects were required to have participated in the safety phase, had ablation procedures for paroxysmal atrial fibrillation (PAF) performed with the SMARTTOUCH® SF Catheter (STSF) catheter, and provided consent for the extended follow-up
The 12-month effectiveness endpoint was defined as freedom from documented AF, atrial tachycardia (AT), and/or atrial flutter (AFL)—hereinafter collectively referred to as atrial tachyarrhythmia—based on electrocardiographic data
Summary
Atrial fibrillation (AF) is the most common arrhythmia diagnosed in clinical practice and the prevalence is increasing as the US population ages [1, 2]. In patients with paroxysmal atrial fibrillation (PAF) refractory to drug York, NY, USA. J Interv Card Electrophysiol (2021) 61:63–69 treatment, radiofrequency (RF) catheter ablation is an important treatment option that has been shown to be superior to antiarrhythmic drug treatment [6, 7]. A 56-hole porous tip has been incorporated in the original CF-sensing catheter design to produce more uniform cooling with less fluid delivery [9, 10]. Compared with the traditional six-hole irrigation system, the porous tip catheter improves procedural efficiency and reduces fluid delivery [11, 12], while maintaining the safety profile for PAF ablation [9]
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