Composite Index Tagging for PVI in Paroxysmal AF: A Prospective, Multicenter Postapproval Study.

BACKGROUND: VISITAG SURPOINT (VS)-guided ablation of paroxysmal atrial fibrillation has demonstrated good short- and long-term success rates with low rates of complications in recent, predominantly European, studies. However, there is a lack of multicenter data from the United States. OBJECTIVES: This U.S. study evaluated the safety and effectiveness of VS ablation using a contact force-sensing catheter for the treatment of drug-refractory symptomatic paroxysmal atrial fibrillation. METHODS: The prospective, nonrandomized VS postapproval study was conducted at 32 U.S. sites. Ablation consisted of pulmonary vein isolation with recommended VS index targets (anterior, roof, or ridge: 550; posterior or inferior: 380). Additional non-pulmonary vein triggers were ablated at the investigators' discretion. Subjects were followed for 12 months, including a 3-month blanking period. The primary safety endpoint was the primary adverse event rate up to 7 days postablation. The primary effectiveness endpoint was 12-month freedom from atrial tachyarrhythmia recurrence and an additional set of failure modes based on stringent monitoring (weekly transtelephonic monitoring [TTM] [day 91 through month 5], monthly TTM [months 6 to 12], and any symptomatic cardiac episode using TTM, plus electrocardiogram [at discharge, 1 month, 3 months, 6 months, and 12 months] with 24-hour Holter monitoring [12 months]). RESULTS: Of 283 patients enrolled, 261 had the catheter inserted and underwent ablation (safety cohort); 246 met all eligibility criteria (effectiveness cohort). Mean fluoroscopy time was 2.2 minutes. Mean amount of catheter-delivered fluid was 671 mL; only 18.0% of patients utilized a Foley catheter. Primary safety and effectiveness endpoints were met. The raw primary adverse event rate was 4.3% (14 events, n = 11). At 12 months, the Kaplan-Meier estimate of freedom from primary effectiveness failure was 76.4%; estimates of 12-month freedom from documented atrial fibrillation, atrial tachycardia, or atrial flutter recurrence were 81.5% and 92.7% per stringent monitoring and standard-of-care monitoring (excluding TTM), respectively. The first-pass isolation rate was 83.1%, represented by no acute reconnection after the 30-minute waiting period. Freedom from repeat ablation at 12 months was 94.0%. CONCLUSIONS: The VS postapproval study confirms reproducibility of clinical safety and effectiveness of the standardized VS paroxysmal atrial fibrillation ablation workflow with >80% 12-month freedom from atrial tachyarrhythmia recurrence and first-pass isolation rate of 83.1%. Procedures were performed with minimal fluoroscopy. (Evaluation of VISITAG SURPOINT™ Module With External Processing Unit [EPU]; NCT03624881).