Safety and efficacy of the nMARQ catheter for paroxysmal and persistent atrial fibrillation

Europace. 2016 Aug;18(8):1164-9. doi: 10.1093/europace/euw048. Epub 2016 May 31.

Abstract

Aims: Circular irrigated radiofrequency ablation using the nMARQ catheter has recently been introduced for the treatment of atrial fibrillation (AF). The aim of this study is to report the safety and efficacy of catheter ablation using this technology in patients with paroxysmal and persistent AF.

Methods and results: The data of a prospective registry describing the experience of a single operator using this technology on 327 consecutive patients were analysed. The mean procedure time was 69 ± 22 min for paroxysmal AF (n = 228) and 75 ± 23 min for persistent AF (n = 97). Follow-up was available for 206 (63%) patients for 6 ± 5 months (range 1-23, median 3.3). Single procedure success off antiarrhythmic drugs was 75% in paroxysmal AF and 52% in persistent AF. Including the 5% redo cases and those on antiarrhythmic medication, freedom from AF was documented in 90 and 83% of paroxysmal and persistent AF patients, respectively. There were no serious complications in the first 325 patients, but the last two consecutive patients (0.6%) developed atrio-oesophageal fistulas and had a fatal outcome. The catheter has been recalled from market.

Conclusion: The nMARQ catheter is a highly effective tool for treatment of paroxysmal and persistent AF. Nevertheless, the occurrence of life-threatening oesophageal fistulas is of major concern and requires further investigation.

Keywords: Ablation; Atrial fibrillation; Atrio-oesophageal fistula; Pulmonary vein isolation; nMARQ.

MeSH terms

  • Aged
  • Anti-Arrhythmia Agents / therapeutic use
  • Atrial Fibrillation / classification
  • Atrial Fibrillation / therapy*
  • Catheter Ablation / adverse effects
  • Catheter Ablation / instrumentation*
  • Equipment Design
  • Esophageal Fistula / physiopathology*
  • Female
  • Follow-Up Studies
  • Humans
  • Logistic Models
  • Male
  • Medical Device Recalls*
  • Middle Aged
  • Operative Time
  • Prospective Studies
  • Proton Pump Inhibitors / therapeutic use
  • Pulmonary Veins / surgery
  • Switzerland
  • Treatment Outcome

Substances

  • Anti-Arrhythmia Agents
  • Proton Pump Inhibitors