An occlusion-first strategy for combined LAAO and catheter ablation was superior to an ablation-first strategy for event-free survival (83.5% vs 71.1%; HR 0.53; 95% CI 0.29-0.95; P=0.04).
RCT (n=202)
randomly assigned
Yes
Does an occlusion-first strategy improve event-free survival compared to an ablation-first strategy in patients with nonvalvular atrial fibrillation undergoing a combined LAAO and catheter ablation procedure?
An occlusion-first strategy during combined LAAO and catheter ablation procedures significantly improves event-free survival and long-term freedom from atrial tachyarrhythmias compared to an ablation-first strategy.
Hazard Ratio: 0.53 (95% CI 0.29–0.95)
Absolute Event Rate: 83.5% vs 71.1%
p-value: p=.04
Importance: The optimal strategy of combining left atrial appendage occlusion (LAAO) with catheter ablation (CA) in patients with atrial fibrillation (AF) during a single procedure remains unclear. Objective: To determine the effects of ablation-first vs occlusion-first strategies on long-term clinical outcomes among patients with atrial fibrillation undergoing a combined LAAO and CA procedure. Design, Setting, and Participants: The prospective, multicenter COMBINATION randomized clinical trial was conducted in 14 high-volume centers in China. Enrollment of patients with nonvalvular AF referred for the combined procedure began on July 24, 2020, and concluded on January 20, 2022. Interventions: Patients were randomly assigned to either the ablation-first group or the occlusion-first group. Outcomes of LAAO using an occlusion device and CA using a contact force-sensing catheter following different combination strategies during long-term follow-up were evaluated. Main Outcomes and Measures: The primary end point was a composite of thromboembolic events including stroke or transient ischemic attack, device-related thrombus (DRT), clinically relevant bleeding, and cardiovascular rehospitalization or death. Freedom from AF or atrial tachyarrhythmia (ATA) after a single procedure without antiarrhythmic drugs, at both 1 year and long-term follow-up, was also evaluated. Results: Of the 202 patients enrolled, 194 (96.0%) completed the trial (97 in the ablation-first group and 97 in the occlusion-first group). The mean (SD) age of the cohort was 67.3 (9.2) years, and 110 patients (56.7%) were male. All procedures achieved acute successful LAAO and restoration of sinus rhythm, with similar incidences of periprocedural complications. Compared with the ablation-first group, the occlusion-first group exhibited significantly higher event-free survival of the primary end point (83.5% vs 71.1%; hazard ratio HR, 0.53 95% CI, 0.29-0.95; log-rank P = .04) during the median 2.5 (IQR, 2.3-2.8) years of follow-up. Subgroup analysis indicated that male patients and those with higher CHA2DS2-VASc scores (a composite of factors associated with stroke risk; higher scores indicate higher risk) were at lower risk of thromboembolic events. Rates of long-term freedom from AF (77.3% vs 63.5%; HR, 0.58 95% CI, 0.34-0.97; log-rank P = .04) and from ATA (70.1% vs 55.7%; HR, 0.62 95% CI, 0.39-0.99; log-rank P = .04) were higher in the occlusion-first group vs the ablation-first group. Additionally, a higher incidence of chronic peridevice leak (15 15.5% vs 5 5.2%; P = .03) and DRT (8 8.2% vs 1 1.0%; P = .04) was observed in the ablation-first group vs the occlusion-first group. Conclusions and Relevance: In this randomized clinical trial, the occlusion-first approach was superior due to its higher event-free survival of the primary end point and long-term freedom from ATA. These findings suggest that the occlusion-first approach should be recommended for combined procedures with plug-like device implantation. Trial Registration: Chinese Clinical Trial Registry Identifier: ChiCTR2000031486.
Du et al. (Fri,) conducted a rct in nonvalvular atrial fibrillation (n=202). Occlusion-first strategy vs. Ablation-first strategy was evaluated on composite of thromboembolic events including stroke or transient ischemic attack, device-related thrombus (DRT), clinically relevant bleeding, and cardiovascular rehospitalization or death (HR 0.53, 95% CI 0.29-0.95, p=.04). An occlusion-first strategy for combined LAAO and catheter ablation was superior to an ablation-first strategy for event-free survival (83.5% vs 71.1%; HR 0.53; 95% CI 0.29-0.95; P=0.04).