Results of the first investigator-initiated randomized clinical trial of nMARQTM, PVACTM, and thoracoscopic ablation for paroxysmal atrial fibrillation

Europace. 2018 Nov 1;20(FI_3):f384-f391. doi: 10.1093/europace/eux267.

Abstract

Aims: To investigate the effect of minimally invasive thoracoscopic surgical ablation and nMARQ irrigated multi-electrode phased radiofrequency (RF) ablation to treat paroxysmal atrial fibrillation (AF) compared with PVAC multi-electrode phased RF ablation, with beat-to-beat device-derived Holter monitoring throughout the study duration.

Methods and results: An investigator-initiated prospective trial of patients with paroxysmal AF randomized (1:1:1) to initial surgical, nMARQ or PVAC ablation. All patients had continuous beat-to-beat monitoring with an ILR or pacemaker to evaluate and document AF recurrence. There was a strong trend (P = 0.050) toward difference in AF outcome, with surgical AF ablation more efficacious than catheter ablation. At one year, the proportion of patients with less than 1% AF burden after one procedure and off all antiarrhythmic drugs was 63, 56, and 90% for PVAC, nMARQ and surgical ablations respectively. There were significantly more repeat ablations in the catheter ablation groups (P = 0.008): 25% PVAC, 27% nMARQ, 0% surgery. However, 7 of 20 (35%) of patients undergoing surgical ablation suffered a procedural complication, including two sternotomies for bleeding and one death. This was higher than for catheter ablation (P < 0.001). Surgical ablation took longer to perform (P < 0.001) and had a longer hospital admission (P < 0.001) than catheter ablation.

Conclusion: Surgical AF ablation required significantly fewer repeat procedures than catheter ablation, and there was a clear trend towards improved arrhythmia outcome. However, it was associated with a significantly higher rate of procedural complications. Surgical ablation for paroxysmal AF is promising, however more prospective outcome data is required.

Clinical trial registration: NCT01504451, http://clinicaltrials.gov/show/NCT01504451.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Action Potentials
  • Aged
  • Anti-Arrhythmia Agents / therapeutic use
  • Atrial Fibrillation / diagnosis
  • Atrial Fibrillation / mortality
  • Atrial Fibrillation / physiopathology
  • Atrial Fibrillation / surgery*
  • Catheter Ablation / adverse effects
  • Catheter Ablation / methods*
  • Catheter Ablation / mortality
  • Electrocardiography, Ambulatory
  • England
  • Female
  • Heart Conduction System / physiopathology
  • Heart Conduction System / surgery*
  • Heart Rate
  • Humans
  • Length of Stay
  • Male
  • Middle Aged
  • Operative Time
  • Postoperative Complications / etiology
  • Progression-Free Survival
  • Prospective Studies
  • Recurrence
  • Reoperation
  • Risk Factors
  • Thoracic Surgery, Video-Assisted / adverse effects
  • Thoracic Surgery, Video-Assisted / methods*
  • Thoracic Surgery, Video-Assisted / mortality
  • Time Factors

Substances

  • Anti-Arrhythmia Agents

Associated data

  • ClinicalTrials.gov/NCT01504451