Long-term safety and effectiveness of paroxysmal atrial fibrillation ablation using a porous tip contact force-sensing catheter from the SMART SF trial

• Authors: Andrea Natale, Texas Cardiac Arrhythmia Research Foundation; George Monir, Florida Hospital Cardiovascular Research; Anshul Patel, Emory University; Robert S. Fishel, Florida Electrophysiol Associates; Francis E. Marchlinski, University of Pennsylvania; M. Craig Delaughter, HeartPlace; Charles A. Athill, San Diego Cardiac Center; Daniel P. Melby, Abbott Northwestern Hospital; Mario D. Gonzalez, Penn State Milton S Hershey Medical Center; Ramesh Hariharan, University of Texas Physicians - EP Heart; Brett Gidney, Santa Barbara Cottage Hospital; Tiffany Tan, Biosense Webster Inc; Larry A. Chinitz, New York University
• Journal Title: JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY
• Volume: Volume 61, Number 1
• Publisher: SPRINGER | 2020-05-27, Pages 63-69
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1007/s10840-020-00780-4
• Subjects: Health Sciences, Medicine and Surgery
• Keywords: Science & Technology; Life Sciences & Biomedicine; Cardiac & Cardiovascular Systems; Cardiovascular System & Cardiology; Efficacy; Contact force; Paroxysmal atrial fibrillation; Porous tip; Radiofrequency catheter ablation; SmartTouch SF; SURROUND FLOW CATHETER; EFFICACY; IMPACT; RISK; TECHNOLOGY; RECURRENCE; STROKE

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.