HotBalloon Ablation of the Pulmonary Veins for Paroxysmal AF - HotBalloon Ablation

Jan 10, 2017
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Toray Industries, Inc.
Date Published:
12/27/2016
Date Updated:
01/10/2017
Original Posted Date:
01/10/2017
References

Contribution To Literature:

This trial showed that HotBalloon ablation of pulmonary veins was superior to antiarrhythmic drug therapy at achieving freedom from atrial fibrillation.

Description:

The goal of the trial was to evaluate treatment with HotBalloon ablation compared with antiarrhythmic drug therapy among patients with refractory paroxysmal atrial fibrillation.

Study Design

  • Randomized
  • Parallel

Patients with paroxysmal atrial fibrillation refractory to drug therapy were randomized to HotBalloon ablation of pulmonary veins (n = 104) versus continued antiarrhythmic drug therapy (n = 49).

  • Total number of enrollees: 153
  • Duration of follow-up: 9 months
  • Mean patient age: 59 years
  • Percentage female: 20%
  • Percentage with diabetes: 3.0%

Inclusion criteria:

  • Paroxysmal atrial fibrillation refractory to antiarrhythmic drug therapy
  • Those 20-75 years of age

Exclusion criteria:

  • Previous left atrium ablation or surgery for atrial fibrillation
  • Refractory to the following medications: pilsicainide, cibenzoline, propafenone, disopyramide, and flecainide
  • New York Heart Association functional class III or IV
  • History of myocardial infarction or unstable angina in last 6 months
  • Severe ischemic heart disease, valvular disease, severe pulmonary hypertension, carotid occlusion, or deep-vein thrombosis
  • Left atrial appendage closure device, artificial heart valve, pacemaker, implantable cardioverter-defibrillator, or inferior vena cava filter
  • History of cerebral infarction or intracerebral bleeding with apparent neurological symptoms during the previous 6 months
  • Left atrial diameter ≥50 mm
  • Left ventricular ejection fraction <35%
  • Left atrial thrombus

Principal Findings:

The primary outcome, incidence of success, occurred in 59.0% of the HotBalloon ablation group vs. 4.7% of the antiarrhythmic drug therapy group (p < 0.001).

Secondary outcomes:

  • Serious adverse events: 10.4% of the HotBalloon ablation group vs. 4.7% of the antiarrhythmic drug therapy group
  • Major complications among the HotBalloon ablation group: 11.2% (2.0% with cerebral infarction, 3.7% with phrenic nerve paralysis, and 5.2% with pulmonary vein stenosis)

Interpretation:

Among patients with atrial fibrillation refractory to antiarrhythmic drug therapy, HotBalloon ablation was effective at maintaining sinus rhythm compared with continued antiarrhythmic drug therapy. There were a modest number of complications with this technique including cerebral infarction, phrenic nerve paralysis, and pulmonary vein stenosis, which will need to be further examined in future studies. This technique also needs to be compared against other methods of left atrial ablation such as the CryoBalloon technique.

References:

Sohara H, Ohe T, Okumura K, et al. HotBalloon Ablation of the Pulmonary Veins for Paroxysmal AF: A Multicenter Randomized Trial in Japan. J Am Coll Cardiol 2016;68:2747-57.

Keywords: Anti-Arrhythmia Agents, Arrhythmias, Cardiac, Atrial Appendage, Atrial Fibrillation, Catheter Ablation, Cerebral Infarction, Phrenic Nerve, Pulmonary Veins, Secondary Prevention


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