Systematic review and meta analysis of clinical effectiveness safety and midterm recurrence of ventricular pulsed field ablation

Background

Ventricular pulsed field ablation (PFA) is increasingly adopted for premature ventricular complexes (PVC) and ventricular tachycardia (VT), yet the evidence base remains fragmented. We summarised acute effectiveness, ≤30-day safety, and mid-term recurrences from clinical studies.

Purpose

To pool outcomes of ventricular PFA across indications (PVC, VT), estimate between-study heterogeneity, and test robustness in analyses restricted to cohorts with ≥3 patients.

Methods

We performed a systematic review and meta-analysis of clinical reports to 8 September 2025. Primary endpoints were: (1) acute success (PVC: elimination of the clinical focus at procedure end; VT: non-inducibility at procedure end), (2) intra/≤30-day complications, and (3) recurrence incidence (events per patient-year) at longest follow-up. Proportions were synthesised with generalised linear mixed models (logit link; REML). Recurrence was modelled using mixed-effects Poisson models with a person-time offset. Overlapping reports were de-duplicated at patient level; a prespecified sensitivity included only cohorts with ≥3 patients. Heterogeneity was expressed as I² (and prediction intervals when informative).

Results

355 patients (PVC 122, VT 233) from 43 studies were included; mean age 59.3±14.8 years. Mean LVEF was 53.9±11.7% in PVC and 34.8±12.6% in VT. Redo procedures in 43% of all index PFA sessions. Main etiology was ischemic cardiomyopathy in VT group (51%) and idiopahtic in PVC group (72%). Mean follow-up was ~5 months (PVC 155±79 days; VT 152±44 days). Six distinct PFA ablation systems were identified across studies. Hybrid workflows (PFA+RF) occurred in 38%. On average, JBI risk of bias ratings were moderate.

(1)Acute effectiveness: In ≥3-patient cohorts, pooled success was 93% (95% CI 85–99; I²=0%) for PVC and 89% (95% CI 83–93; I²=0%) for VT. When all studies were pooled, estimates were ≈100% (PVC) and ≈99% (VT), with I²=0% for both, consistent with small-study/publication effects.

(2)Safety (≤30 days): In ≥3-patient cohorts, complications were 8% (95% CI 1–21; I²≈47%) for PVC and 10% (95% CI 5–15; I²=0%) for VT. Across all studies, model-based pooled proportions were ≈1% with I²=0% in both indications. Aggregated counts showed 35/355 complications (9.8%) and 6/355 deaths (1.6%), all in VT.

(3)Recurrence: Incidence was 0.33 events/patient-year for PVC (I²=0%) and 0.40–0.44 for VT, with modest heterogeneity for VT (I²≈28% in ≥3-patient analyses); the VT prediction interval was ≈0.19–1.25 events/patient-year, reflecting variability in substrate, approach, and surveillance.

Conclusion

Across heterogeneous platforms and workflows, ventricular PFA demonstrates high acute effectiveness, acceptable near-term safety, and consistent mid-term durability. Estimates restricted to ≥3 patients studies appear more generalisable than all-study pools and suggest small-study effects. Comparative studies and registries with standardised endpoints are warranted.PRISMA 2020 flow diagram