Indirect comparison suggests Sphere-9 PFA catheter may have higher efficacy than Farawave for persistent AF
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Key Takeaway
Consider indirect PFA comparison data cautiously; head-to-head RCT validation is needed.
This analysis used matched-adjusted indirect comparison (MAIC) methods to indirectly compare two pulsed field ablation (PFA) systems in patients with symptomatic persistent atrial fibrillation (PerAF). Data came from two separate trials: the SPHERE Per-AF trial (N=212) using the dual-energy, wide-footprint lattice-tip Sphere-9 catheter (Medtronic) and the ADVANTAGE AF trial (N=260) using the pentaspline Farawave catheter (Boston Scientific). The primary outcome was 12-month freedom from arrhythmias.
The adjusted analysis found the Sphere-9 system was associated with a significantly higher probability of 12-month freedom from arrhythmias compared to the Farawave system (77.4% vs. 63.5%; OR 0.51, 95% CI: 0.32-0.80, p=0.003). Fluoroscopy time was also significantly shorter with the Sphere-9 system (mean difference -14.4 minutes, 95% CI: -16.2 to -12.5, p<0.01). There was no evidence of a significant difference in the primary safety outcome between the systems (adjusted event rates: 1.8% vs. 2.3%; OR 0.76, 95% CI: 0.17-3.42, p=0.72). Specific adverse event rates, serious adverse events, and tolerability data were not reported.
Key limitations include the inherent constraints of an indirect treatment comparison, as patients were not randomized head-to-head between the two devices. The authors note results must be validated in prospective randomized trials. The analysis suggests possible differences in efficacy and efficiency exist among PFA systems, but clinicians should interpret these findings cautiously as associations from indirect evidence, not established causal superiority.
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View Original Abstract ↓
BACKGROUND: Catheter ablation is beneficial in patients with symptomatic persistent atrial fibrillation (PerAF), and pulsed field ablation (PFA) is a promising energy source to safely and durably create ablation lesions. However, catheter-specific "PFA waveforms and designs" result in effectiveness and safety profiles that are not transferable to other PFA technologies. A head-to-head comparison between the dual-energy, wide-footprint lattice-tip (Sphere-9, Medtronic) and pentaspline PFA catheter (Farawave, Boston Scientific) is not yet available. Consequently, this study aims to perform an indirect treatment comparison (ITC).
METHODS: Outcomes (efficacy, safety, and procedure times) between the SPHERE Per-AF trial (N = 212; NCT05120193) and ADVANTAGE AF trial (N = 260; NCT05443594) studies were compared using matched-adjusted indirect comparison (MAIC) methods. Matching was performed based on subjects' baseline characteristics.
RESULTS: After matching, SPHERE Per-AF showed a higher probability (OR 0.51 (95% CI:0.32 - 0.80), p = 0.003) of 12-month freedom from arrhythmias (77.4%) compared to ADVANTAGE AF (63.5%). There was no evidence of adjusted probability of a primary safety difference (OR 0.76 (95% CI:0.17 - 3.42), p = 0.72) between trials (1.8% vs. 2.3%, respectively). Adjusted procedure and pulmonary vein isolation time were comparable, but fluoroscopy time was significantly shorter in SPHERE Per-AF compared to ADVANTAGE AF (-14.4 min (95% CI:-16.2, -12.5); p < 0.01).
CONCLUSION: PFA is generally safe and efficient; however, in this ITC, SPHERE Per-AF showed a higher probability of treatment success in PerAF patients compared to ADVANTAGE AF. Overall, these results underline possible differences even amongst PFA systems, which must be validated in randomized trials. Until then, MAIC methods fill the current evidence gap. Registry and the Registration No. SPHERE Per-AF: NCT05120193 and ADVANTAGE AF: NCT05443594.
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