Composite Index Tagging for PVIinParoxysmal AF: A Prospective, Multicenter Postapproval Study.

Abstract

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. 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. 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 12months, including a 3-month blanking period. The primary safety endpoint was the primary adverse event rate up to 7days 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 [atdischarge, 1month, 3months, 6months, and 12months] with 24-hour Holter monitoring [12months]). Of 283 patients enrolled, 261 had the catheter inserted and underwent ablation (safety cohort); 246 metall eligibility criteria (effectiveness cohort). Mean fluoroscopy time was 2.2minutes. Mean amount of catheter-delivered fluid was 671mL; 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 12months, 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 12months was 94.0%. 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).