Long-Term Durability of High- and Very High-Power Short-Duration PVI by Invasive Remapping: The HPSD Remap Study

Abstract

BACKGROUND: High-power short-duration ablation has shown impressive efficacy and safety for pulmonary vein isolation (PVI); however, initial efficacy results with very high power short-duration ablation were discouraging. This study compared the long-term durability of PVI performed with a 90- versus 50-W power setting. METHODS: Patients were randomized 1:1 to undergo PVI with the QDOT catheter using a power setting of 90 or 50 W. Three months after the index procedure, patients underwent a repeat electrophysiology study to identify pulmonary vein reconnections. Patients were followed for 12 months to detect AF recurrences. RESULTS: We included 46 patients (mean age, 64 years; women, 48%). Procedure (76 versus 84 minutes; P  =0.02), left atrial dwell (63 versus 71 minutes; P  =0.01), and radiofrequency (303 versus 1040 seconds; P  <0.0001) times were shorter with 90- versus 50-W procedures, while the number of radiofrequency applications was higher with 90 versus 50 W (77 versus 67; P  =0.01). There was no difference in first-pass isolation (83% versus 82%; P  =1.0) or acute reconnection (4% versus 14%; P  =0.3) rates between 90 and 50 W. Forty patients underwent a repeat electrophysiology study. Durable PVI on a per PV basis was present in 72/78 (92%) versus 68/77 (88%) PVs in the 90- and 50-W energy setting groups, respectively; effect size: 72/78−68/77=0.040, lower 95% CI=−0.051 (noninferiority limit=−0.1, ie, noninferiority is met). No complications occurred. There was no difference in 12-month atrial fibrillation-free survival between the 90- and 50-W groups ( P  =0.2). CONCLUSIONS: Similarly high rates of durable PVI and arrhythmia-free survival were achieved with 90 and 50 W. Procedure, left atrial dwell, and radiofrequency times were shorter with 90 W compared with 50 W. The sample size is too small to conclude the safety and long-term efficacy of the high and very high-power short-duration PVI; further studies are needed to address this topic. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05459831.