High-Power Short-Duration vs Low-Power Long-Duration Ablation for Pulmonary Vein Isolation: A Substudy of the AWARE Randomized Controlled Trial
Joza, J.; Nair, G. M.; Birnie, D. H.; Nery, P. B.; Redpath, C. J.; Sarrazin, J.-F.; Champagne, J.; Roux, J.-F.; Dussault, C.; Parkash, R.; Bernier, M.; Sterns, L.; Sapp, J. L.; Novak, P.; Veenhuyzen, G.; Morillo, C. A.; Singh, S. M.; Sadek, M.; Golian, M.; Klein, A.; Sturmer, M.; Chauhan, V.; Angaran, P.; Green, M. S.; Bernick, J.; Wells, G. A.; Essebag, V.
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BackgroundPulmonary vein isolations (PVI) are being performed using a high-power, short duration (HPSD) strategy. The purpose of this study was to compare the clinical efficacy and safety outcomes of a HPSD vs low-power long duration (LPLD) approach to PVI in patients with paroxysmal atrial fibrillation (AF). MethodsPatients were grouped according to a HPSD ([≥]40 W) or LPLD ([≤] 35 W) strategy. The primary endpoint was the one-year recurrence of any atrial arrhythmia lasting [≥] 30 seconds, detected using three 14-day ambulatory continuous ECG monitoring. Procedural and safety endpoints were also evaluated. The primary analysis were regression models incorporating propensity scores yielding adjusted relative risk (RRa) and mean difference (MDa) estimates. ResultsOf the 398 patients included in the AWARE Trial, 173 (43%) underwent HPSD and 225 (57%) LPLD ablation. The distribution of power was 50 W in 75%, 45 W in 20% and 40 W in 5% in the HPSD group, and 35W with 25W on the posterior wall in the LPLD group. The primary outcome was not statistically significant at 30.1% vs 22.2% in HPSD and LPLD group with RRa 0.77 (95% confidence interval [CI]) 0.55-1.10; p=0.165). The secondary outcome of repeat catheter ablation was not statistically significant at 6.9% and 9.8% (RRa 1.59 [95% CI 0.77-3.30]; p=0.208) respectively. The incidence of any ECG documented AF during the blanking period was numerically lower in the HPSD group: 1.7% vs 8.0% (RRa 3.95 [95% CI 1.00-15.61; p=0.049). The total procedure time was significantly shorter in the HPSD group (MDa 97.5 minutes [95% CI 84.8-110.4)]; p<0.0001) with no difference in adjudicated serious adverse events. ConclusionsA HPSD strategy was associated with significantly shorter procedural times with similar efficacy in terms of clinical arrhythmia recurrence. Importantly, there was no signal for increased harm with a HPSD strategy. Graphical Abstract O_FIG O_LINKSMALLFIG WIDTH=200 HEIGHT=164 SRC="FIGDIR/small/23291526v1_ufig1.gif" ALT="Figure 1"> View larger version (50K): org.highwire.dtl.DTLVardef@915125org.highwire.dtl.DTLVardef@6684a4org.highwire.dtl.DTLVardef@8e3679org.highwire.dtl.DTLVardef@9a54ae_HPS_FORMAT_FIGEXP M_FIG C_FIG Non-standard Abbreviations and AcronymsHPSD: High-Power Short Duration; LPLD: Low-Power Long Duration; QOL: Quality of Life; WACA: wide area circumferential ablation; PVI: Pulmonary Vein Isolation; AF: Atrial Fibrillation Clinical PerspectiveO_ST_ABSWhat is knownC_ST_ABS-The optimal power and duration of ablation lesions to produce durable pulmonary vein isolation remain unclear. -Nonrandomized studies have suggested clinical efficacy with high-power short duration radiofrequency ablation vs low-power long duration. What this study adds-In this large substudy of the AWARE Trial, a high-power short duration radiofrequency ablation strategy was found to be similarly effective as a low-power long duration strategy with no difference in time to first recurrence of any AF lasting [≥] 30 seconds. -Procedural were substantially reduced with high-power short duration ablation with no significant difference in overall complication rates.
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