B-AB21-01 REPRODUCIBILITY OF OPTIMIZED TAG INDEX-GUIDED CATHETER ABLATION FOR PULMONARY VEIN ISOLATION IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION - THE SURPOINT POST-APPROVAL STUDY

Durable and contiguous lesions of pulmonary vein isolation (PVI) minimize arrhythmia recurrence. European studies demonstrated a new Tag Index (TI)-guided ablation combining power, time and contact force improved procedural efficiencies and long-term effectiveness. Multicenter US data is limited. Evaluate the reproducible safety and effectiveness of TI-guided ablation using a contact force-sensing catheter for treating drug-refractory symptomatic paroxysmal atrial fibrillation in a US post-approval study. This prospective, multicenter, nonrandomized study was conducted at 30 US sites. Pulmonary vein isolation was done with recommended TI targets of 550 at anterior/roof/ridge and 380 at posterior/inferior; non-PV ablations were completed at investigator’s discretion. The primary effectiveness endpoint was 12M freedom from atrial arrhythmia recurrences and additional 5 failure modes (acute procedural failure, AAD failure, repeat ablation, DC cardioversion for AF/AFL/AT during evaluation period or surgical treatment for AF/AFL/AT after index procedure). Stringent monitoring included transtelephonic monitoring (symptomatic, weekly from months 2-5, monthly from months 6-12), ECG (months 1, 3, 6, 12) and Holter monitoring (month 12). The primary safety endpoint was primary adverse event (PAE) rate ≤7 days post-ablation. Planned 6M early success interim analysis data is reported. Of 283 patients enrolled, 246 were ablated and met all eligibility criteria. Mean procedure and fluoroscopy times were 147.6 ± 41.5 and 2.1 ± 4.5 minutes, respectively. The PAE rate was 3.5% (10 events/9 patients); Kaplan Meier estimated freedom from primary effectiveness failure at 12M was 72.5%. Freedom from documented 12M AF/AT/AFL recurrence was 78.2%. The TI mean posterior target reached was 376.2 ± 27.3 and mean anterior target was 495.6 ± 52.4. The lower/upper limit of 95% CI TI targets for 90% of subjects were 300-562 and 290-443 for the anterior/ridge/superior and posterior/inferior wall, respectively. The study confirms the reproducibility of optimized TI targets in achieving safe and effective PVI with minimal fluoroscopy, low PAE, and a highly effective 12M freedom from recurrence approaching 80%.