Two versus one repeat freeze-thaw cycle(s) after cryoballoon pulmonary vein isolation: the alster extra pilot study

J Cardiovasc Electrophysiol. 2012 Aug;23(8):814-9. doi: 10.1111/j.1540-8167.2012.02315.x. Epub 2012 Apr 4.

Abstract

Background: Repeated freezing (bonus applications) during cryoballoon pulmonary vein isolation (PVI) has been suggested to improve lesion durability. However, the long-term clinical effects of repeated freezing have not been investigated.

Methods and results: A total of 51 patients (pts) with paroxysmal atrial fibrillation (AF) underwent PVI using the single big (28 mm) cryoballoon technique. One (27 pts, group I) or 2 bonus applications (24 pts, group II) were performed at all PVs subsequent to PVI. Clinical follow-up consisted of continuous rhythm monitoring by an implantable cardiac monitor (ICM, 24 pts) and serial 7-day Holter-ECG recording (7DH, 27 pts). The primary endpoint was defined as recurrent AF or atrial tachycardia. Acute PVI of all PVs was obtained in 50/51 pts (98%). The median (Q1;Q3) follow-up duration in this study was 384 (213;638) days. The primary endpoint occurred in 48% (group I, 15 pts ICM, 12 pts 7DH) and 46% (group II, 9 pts ICM, 15 pts 7DH), P = 0.84. Procedure- and fluoroscopy-time for group I versus group II was 193 ± 56 minutes versus 207 ± 27 and 33 ± 13 minutes versus 34 ± 11 minutes, respectively. Right phrenic nerve palsy (PNP) occurred in 3 pts (all group II, time to resolution: 128 ± 112 days). In 2 of these pts, PNP occurred during the second bonus application.

Conclusion: Application of 2 when compared to 1 freeze-thaw cycle(s) following cryoballoon PVI did not result in improved clinical success but was associated with a higher complication rate.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Atrial Fibrillation / diagnosis
  • Atrial Fibrillation / physiopathology
  • Atrial Fibrillation / surgery*
  • Catheter Ablation / adverse effects
  • Catheter Ablation / instrumentation
  • Catheter Ablation / methods*
  • Chi-Square Distribution
  • Cryosurgery / adverse effects
  • Cryosurgery / instrumentation
  • Cryosurgery / methods*
  • Disease-Free Survival
  • Electrocardiography, Ambulatory
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Paralysis / etiology
  • Peripheral Nerve Injuries / etiology
  • Phrenic Nerve / injuries
  • Pilot Projects
  • Prospective Studies
  • Pulmonary Veins / physiopathology
  • Pulmonary Veins / surgery*
  • Recurrence
  • Risk Assessment
  • Risk Factors
  • Tachycardia, Supraventricular / etiology
  • Telemetry
  • Time Factors
  • Treatment Outcome