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

J Interv Card Electrophysiol. 2016 Mar;45(2):179-87. doi: 10.1007/s10840-015-0092-3. Epub 2015 Dec 23.

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.

Keywords: AF ablation; Circular mapping catheter; Cryoablation; Cryoballoon; Randomized controlled trial.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Atrial Fibrillation / diagnosis
  • Atrial Fibrillation / surgery*
  • Body Surface Potential Mapping / instrumentation*
  • Body Surface Potential Mapping / methods
  • Cardiac Catheterization / instrumentation*
  • Cardiac Catheterization / methods
  • Cryosurgery / instrumentation*
  • Cryosurgery / methods
  • Disease-Free Survival
  • Equipment Design
  • Equipment Failure Analysis
  • Female
  • Humans
  • Male
  • Middle Aged
  • Operative Time
  • Prospective Studies
  • Surgery, Computer-Assisted / instrumentation*
  • Surgery, Computer-Assisted / methods
  • Treatment Outcome
  • Young Adult