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Clinical outcomes of AF patients treated with the first and second-generation of circular mapping and ablation catheter: insights from a real world multicenter experience

Abstract

Purpose

Complete pulmonary vein isolation (PVI) is the best documented target for catheter ablation, and different technologies have shown comparable outcomes. The multielectrode phased-RF/duty cycled (PhRF/DC) pulmonary vein ablation catheter (PVAC) and its second generation (PVAC-GOLD) have shown promising clinical results in single and multicenter experiences. Our aim is to assess and compare the safety and efficacy in the real clinical practice among two generations of circular PhRF/DC catheters by performing PVI in patients suffering from recurrent atrial fibrillation (AF).

Methods

Eighty-four AF patients treated with PVAC and 64 with PVAC-GOLD were prospectively followed in five Italian cardiology centers in the mainframe of the 1STOP-ClinicalService project.

Results

Fluoroscopic and total procedure time were significantly different in the two groups. In particular, in the PVAC-GOLD group, the mean fluoroscopic time was 22.8 ± 12.7 min vs 31.6 ± 18.9 in the PVAC group (p = 0.002), and the mean total procedure duration was 117.6 ± 36.0 vs 147.4 ± 40.6, in the PVAC-GOLD group and the PVAC group, respectively (p = 0.001). Only two out of 148 patients reported a peri-procedural complication. Over 20.9 ± 12.0 months of follow-up, AF recurrence occurred in 58 patients. Kaplan-Meier freedom from AF recurrence did not differ between the two groups (64.1 ± 10% in the PVAC group vs 68.2 ± 9% in the PVAC-GOLD group at 1 year, p = ns).

Conclusions

In our multicenter analysis, AF ablation using two generations of circular PhRF/DC catheters is safe and effective. No difference was observed in terms of safety and efficacy of the AF ablation between the two catheters, with the mean procedural time being shorter in the PVAC-GOLD group.

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Correspondence to Giovanni Rovaris.

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Compliance with ethical standards

The project was approved by each site’s Medical Ethics Committee or Medical Director and conforms to the principles outlined in the Declaration of Helsinki. Each patient provided informed consent for data collection and analysis.

Competing interests

The authors declare that they have no conflicts of interest.

Funding

This research was performed within the framework of the Italian ClinicalService, a project funded by Medtronic Italia, an affiliate of Medtronic Inc. No other funding sources were involved in the research.

Additional information

http://clinicaltrials.gov/ct2/show/NCT01007474

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Rovaris, G., De Filippo, P., Laurenzi, F. et al. Clinical outcomes of AF patients treated with the first and second-generation of circular mapping and ablation catheter: insights from a real world multicenter experience. J Interv Card Electrophysiol 50, 245–251 (2017). https://doi.org/10.1007/s10840-017-0278-y

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  • DOI: https://doi.org/10.1007/s10840-017-0278-y

Keywords

  • Atrial fibrillation
  • Ablation of atrial fibrillation
  • Pulmonary vein isolation
  • PVAC-GOLD