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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

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Journal of Interventional Cardiac Electrophysiology Aims and scope Submit manuscript

Abstract

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

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Acknowledgments

Grateful thanks to senior research sister Janet Large and research trials officer Jet van Zalen and Pamela Morley for administrative assistance throughout the trial. Thanks also to Professor Nick Freemantle for his statistical advice.

Conflict of interest

The authors declare that they have no competing interest.

Funding

The left atrial ablation in paroxysmal atrial fibrillation patients with pacemaker or implantable cardiac monitor follow-up trial was funded by the Eastbourne Cardiology Research Charity Fund (Registration Number: 1120215).

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Authors and Affiliations

  1. Cardiology Research Department, East Sussex Healthcare NHS Trust, Eastbourne Gen Hospital, Kings Drive, Eastbourne, East Sussex, BN21 2UD, UK

    S. J. Podd, A. N. Sulke, C. Sugihara & S. S. Furniss

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  1. S. J. Podd
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  2. A. N. Sulke
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Correspondence to S. S. Furniss.

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Podd, S.J., Sulke, A.N., Sugihara, C. et al. 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. J Interv Card Electrophysiol 44, 257–264 (2015). https://doi.org/10.1007/s10840-015-0042-0

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