Comparison of PolarX and the Arctic Front Cryoballoons for PVI in Patients With Symptomatic Paroxysmal AF - COMPARE CRYO

May 22, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Inselspital–University Hospital Bern, Switzerland and the University Hospital Basel, Switzerland.
Date Published:
05/15/2024
Date Updated:
05/22/2024
Original Posted Date:
05/22/2024
References

Contribution To Literature:

The COMPARE CRYO trial showed that the PolarX cryoballoon was noninferior to the Arctic Front cryoballoon; however, it was associated with more phrenic nerve palsy.

Description:

The goal of the trial was to evaluate two different cryoballoons during pulmonary vein isolation among patients undergoing ablation for symptomatic paroxysmal atrial fibrillation.

Study Design

  • Randomized
  • Parallel

Patients with symptomatic paroxysmal atrial fibrillation were randomized to pulmonary vein isolation with the PolarX cryoballoon (n = 99) vs. pulmonary vein isolation with the Arctic Front cryoballoon (n = 102). All patients received an implantable cardiac monitor.

  • Total number of enrollees: 201
  • Duration of follow-up: 12 months
  • Mean patient age: 62 years
  • Percentage female: 35%
  • Percentage with diabetes: 7%

Inclusion criteria:

  • Patients ≥18 years of age with symptomatic paroxysmal atrial fibrillation

Exclusion criteria:

  • Previous ablation procedure
  • Reversible cause of atrial fibrillation
  • Severe mitral regurgitation
  • Left ventricular ejection fraction <35%
  • New York Heart Association class III/IV heart failure symptoms

Principal Findings:

The primary outcome, recurrence of atrial tachyarrhythmia between days 91 and 365, was 41.6% in the PolarX group vs. 47.1% in the Arctic Front group (p for noninferiority = 0.033).

Secondary outcomes:

  • Recurrence of atrial tachyarrhythmia between days 91 and 365: 41.6% in the PolarX group vs. 47.1% in the Arctic Front group (p for superiority = 0.46)
  • Phrenic nerve palsy: 5 in the PolarX group vs. 0 in the Arctic Front group (p = 0.028)

Interpretation:

Among patients with symptomatic paroxysmal atrial fibrillation, the PolarX cryoballoon was noninferior to the Arctic Front cryoballoon during pulmonary vein isolation. The PolarX cryoballoon was associated with more phrenic nerve palsy. This safety concern will need to be monitored in future studies and during clinic use. It is possible that modification of the catheter might be able to reduce the risk of phrenic nerve palsy.

References:

Reichlin T, Kueffer T, Knecht S, et al. PolarX vs Arctic Front for Cryoballoon Ablation of Paroxysmal AF: The Randomized COMPARE CRYO Study. JACC Clin Electrophysiol 2024;May 15:[Epublished].

Clinical Topics: Arrhythmias and Clinical EP, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Ablation Techniques, Atrial Fibrillation


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