Purpose: Pulmonary vein isolation (PVI) is conventionally performed using 3D electroanatomical mapping to guide point-to-point ablation. The Pulmonary Vein Ablation Catheter (PVAC)® is a phased multipolar ablation (PMRA) catheter designed for rapid PVI using radiological anatomical information. Comparison of these methods of PVI using continuous beat-to-beat monitoring was undertaken.
Methods: Fifty patients with drug-refractory, symptomatic paroxysmal atrial fibrillation (PAF) were recruited. Patients all had REVEAL® XT ILR or a DDDRP permanent pacemaker (PPM) inserted prior to PVI. PPM was programmed to monitoring mode (ODO). Patients were randomised 1:1 to undergo PVI with either point-to-point irrigated radiofrequency ablation (Conv) or PMRA technology. Follow-up was performed at 0, 3, 6, 9, and 12 months using Holter downloads to assess arrhythmia burden. Outcomes were examined following a 3-month blanking period.
Results: The AF burden pre-ablation, at 3-month and at 12-month post-ablations, was not significantly different (pre-ablation AF burdens (mean ± SE) Conv 16.6 ± 5.0%, PVAC 17.0 ± 5.6 %, 3 months Conv 4.0 ± 1.6 %, PVAC 4.7 ± 1.5%, 12 months Conv 4.3 ± 2.3%, PVAC 3.8 ± 1.5%). In both groups, there was a significant reduction in AF burden from pre-ablation (at 3 months p = 0.01, p = 0.04, at 12 months p = 0.04, p = 0.03 for Conv and PMRA groups, respectively). Overall success rate for zero AF recurrence at 12 months was 54%.
Conclusion: PMRA PVI is comparable to conventional technology for AF extinction at 1 year. The PMRA is as safe as conventional technology but enables the operator to perform the procedure faster. Device monitored success rates were lower than other studies not utilising such intensive monitoring confirming that sporadic ECG monitoring is not sufficient to detect all AF recurrence.
Trial registration: NCT01095770. URL: https://clinicaltrials.gov/ct2/show/NCT01095770.
Keywords: AF Ablation; Implantable cardiac monitors; PPM monitoring; PVAC; Pulmonary vein isolation; Reveal XT.