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Evaluation of the Achieve Mapping Catheter in cryoablation for atrial fibrillation: a prospective randomized trial

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Abstract

Purpose

The purpose of this study is to establish the role of Achieve Mapping Catheter in cryoablation for paroxysmal atrial fibrillation (PAF) in a randomized trial.

Methods

A total of 102 patients undergoing their first ablation for PAF were randomized at 2:1 to an Achieve- or Lasso-guided procedure. Study patients were systematically followed up for 12 months with Holter monitoring. Primary study endpoint was acute procedure success. Secondary endpoint was clinical outcomes assessed by AF free at 6 and 12 months after the procedure.

Results

Of 102 participants, 99 % of acute procedure success was achieved. Significantly shorter procedure duration with the Achieve-guided group than with the Lasso-guided group (118 ± 18 vs. 129 ± 21 min, p < 0.05) was observed as was the duration of fluoroscopy (17 ± 5 vs. 20 ± 7 min, p < 0.05) by subgroup analysis focused on procedures performed by experienced operators. In the whole study patients, procedure and fluoroscopic durations were similar in the Achieve- (n = 68) and Lasso-guided groups (n = 34). Transient phrenic nerve weakening was equally prevalent with the Achieve and Lasso. No association was found between clinical outcomes and the mapping catheter used. The use of second-generation cryoballoon (n = 68) reduced procedure time significantly compared to the first-generation balloon (n = 34); more patients were free of AF in the former than the latter group during follow-up.

Conclusions

The use of the Achieve Mapping Catheter can reduce procedure and fluoroscopic durations compared with Lasso catheters in cryoablation for PAF after operators gained sufficient experience. The type of mapping catheter used does not affect procedure efficiency and safety by models of cryoballoon.

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Acknowledgments

This work was supported by an unrestricted educational grant from Medtronic AF Solutions, Medtronic Limited. We wish to thank Gavin Wormull, Ralf Meyer, and Hae Lim of Medtronic AF Solutions for providing research funding and technical support. We thank all Cardiac Physiologists in the EP lab and in the ECG department of St. George’s Hospital, as well as the nursing staff at the lab and James Hope wards, for their constant support in this study.

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Authors and Affiliations

  1. Cardiology Clinical Academic Group, St. George’s University Hospitals NHS Foundation Trust, St. George’s, University of London, London, UK

    Yi Gang, Hanney Gonna, Giulia Domenichini, Michael Sampson, Niloufar Aryan, Mark Norman, Elijah R. Behr, Zia Zuberi, Paramdeep Dhillon & Mark M. Gallagher

  2. National Heart & Lung Institute, Imperial College London, London, UK

    Hanney Gonna

  3. Frimley Park Hospital, Frimley, UK

    Mark Norman

  4. The Royal Surrey County Hospital, Guildford, UK

    Zia Zuberi

  5. St. Peter’s Hospital, Chertsey, UK

    Paramdeep Dhillon & Mark M. Gallagher

  6. Department of Cardiology, St. George’s Hospital, Blackshaw Road, London, SW17 0QT, UK

    Mark M. Gallagher

Authors
  1. Yi Gang
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  2. Hanney Gonna
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  3. Giulia Domenichini
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  4. Michael Sampson
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  5. Niloufar Aryan
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  6. Mark Norman
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  7. Elijah R. Behr
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  8. Zia Zuberi
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  9. Paramdeep Dhillon
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  10. Mark M. Gallagher
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Corresponding author

Correspondence to Mark M. Gallagher.

Ethics declarations

This study complies with the Declaration of Helsinki; the research protocol was approved by the Research Ethical Committee of London, and all participants had given written informed consent before the procedure.

Conflict of interest

The primary investigator (MMG) received research funding from the Medtronic that provided salary for one of the researchers (YG).

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Gang, Y., Gonna, H., Domenichini, G. et al. Evaluation of the Achieve Mapping Catheter in cryoablation for atrial fibrillation: a prospective randomized trial. J Interv Card Electrophysiol 45, 179–187 (2016). https://doi.org/10.1007/s10840-015-0092-3

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  • DOI: https://doi.org/10.1007/s10840-015-0092-3

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