Acute procedural safety of dual-energy ablation for atrial fibrillation:a systematic review and meta-analysis
M I A Bistriceanu, O Makdah, A M Buzarnescu, A C Anghel, C G Ursu, C M Ciuciureanu, A Deaconu, R G VatasescuAbstract
Background
Dual-energy catheter ablation combining radiofrequency (RF) or cryoballoon (CB) and pulsed field ablation (PFA) has recently emerged as a hybrid energy strategy designed to integrate the flexibility of thermal ablation with the tissue selectivity and safety of non-thermal fields. Preliminary studies have reported favorable procedural performance and high acute efficacy, but the overall safety profile of dual-energy (DE) ablation during the early clinical phase remains underexplored.
Purpose
This meta-analysis aimed to systematically evaluate acute procedural safety and early complications following DE ablation for atrial fibrillation (AF).
Methods
A comprehensive search of PubMed, Embase, and Cochrane databases was conducted to identify clinical studies reporting procedural and safety outcomes of DE ablation using either the Affera Sphere-9 or the SmartFIRE system. The primary endpoint was acute pulmonary vein isolation (PVI) success. Secondary endpoints included all acute adverse events within the first seven days. Pooled estimates of proportions were calculated using a Freeman-Tukey double-arcsine random-effects model implemented in R.
Results
Six studies including 644 patients were analyzed, of whom 394 (61.1%) had persistent and 250 (38.9%) paroxysmal AF. The mean age was 64.6 ± 9.6 years, and 66.1% were male. Acute pulmonary vein isolation was achieved in 100% of patients. The pooled rate of overall acute complications was 3.77% (95% CI 1.53 to 6.80; I² = 31%) (Figure 1A). Individual pooled events included complete atrioventricular block in 1 patient (0.16%) (Figure 1B), in-hospital death in 2 patients (0.31%), and pulmonary vein stenosis in 2 patients (0.31%) (Figure 1C). Pooled rates of stroke, vascular-access or bleeding complications, and cardiac tamponade or pericardial effusion were 0.01% (95% CI 0.00 to 0.44), 0.23% (95% CI 0.00 to 1.10), and 0.74% (95% CI 0.00 to 2.74), respectively (Figure 2). Coronary spasm occurred in two cases (0.31%), and transient phrenic-nerve dysfunction was observed in four cases in the only study which combine PFA and CB (0.62%), all resolving spontaneously. No atrio-esophageal fistula, persistent phrenic-nerve injury, myocardial infarction, thromboembolism, or gastroparesis were observed. Heterogeneity was minimal (I² < 10%) across all endpoints, indicating consistent safety performance between the Affera Sphere-9 and SmartFIRE platforms.
Conclusion
In this pooled cohort of 644 patients, dual-energy ablation consistently achieved complete acute PVI with a low incidence of major complications. The findings suggest that combining RF/CB and PFA is feasible and appears safe in the acute setting, though confirmation in larger, randomized studies is warranted to establish its comparative efficacy and long-term safety against single-energy ablation strategies.Figure 1.Meta-analysis of complicationsFigure 2.Forest plots of complications