Abstract
PURPOSE: The 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. METHODS: Ablations 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. RESULTS: Seventy-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. CONCLUSIONS: The SMART SF 12-month follow-up evaluation corroborates the early safety and effectiveness success previously reported for PAF ablation with STSF.