Phased multipolar radiofrequency pulmonary vein isolation is as effective and safe as conventional irrigated point-to-point ablation. A prospective randomised 1-year implantable cardiac monitoring device follow-up trial

• Published in: Journal of interventional cardiac electrophysiology Vol. 44; no. 3; pp. 257 - 264
• Main Authors: Podd, S. J., Sulke, A. N., Sugihara, C., Furniss, S. S.
• Format: Journal Article
• Language: English
• Published: New York Springer US 01-12-2015; Springer Nature B.V
• Subjects: Aged; Atrial Fibrillation - complications; Atrial Fibrillation - diagnosis; Atrial Fibrillation - surgery; Body Surface Potential Mapping - adverse effects; Body Surface Potential Mapping - instrumentation; Body Surface Potential Mapping - methods; Cardiology; Catheter Ablation - adverse effects; Catheter Ablation - instrumentation; Catheter Ablation - methods; Equipment Design; Equipment Failure Analysis; Female; Follow-Up Studies; Heart Conduction System - surgery; Humans; Longitudinal Studies; Male; Medicine; Medicine & Public Health; Pacemaker, Artificial; Postoperative Complications - etiology; Postoperative Complications - prevention & control; Prospective Studies; Prostheses and Implants; Pulmonary Veins - surgery; Therapeutic Irrigation - instrumentation; Therapeutic Irrigation - methods; Treatment Outcome; PPM monitoring; Implantable cardiac monitors; Reveal XT; PVAC; AF Ablation; Pulmonary vein isolation
• ISSN: 1383-875X; 1572-8595
• DOI: 10.1007/s10840-015-0042-0

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