Two-year outcome after pulmonary vein isolation using the second-generation 28-mm cryoballoon: lessons from the bonus freeze protocol

Clin Res Cardiol. 2016 Jan;105(1):72-8. doi: 10.1007/s00392-015-0890-8. Epub 2015 Jul 12.

Abstract

Background: Pulmonary vein isolation (PVI) using the second-generation cryoballoon (CB2) in patients with paroxysmal and persistent atrial fibrillation (AF) has demonstrated encouraging acute and mid-term results. Follow-up data on outcome beyond 1-year is lacking. The purpose of this analysis was to investigate the 2-year clinical outcome after CB2-based PVI.

Methods: Sixty patients (age 62 ± 11 years) with paroxysmal [45/60 (75%) patients] or short-standing persistent AF [15/60 (25%) patients] underwent 28-mm CB2-based PVI. Freeze-cycle duration was 240 s. After successful PVI, a bonus freeze-cycle of the same duration was applied. Follow-up was based on outpatient clinic visits at 3, 6, 12, 18, and 24 months including 24 h Holter-ECGs and telephone interviews. Recurrence was defined as any symptomatic and/or documented atrial tachyarrhythmia (ATA) episode >30 s following a 3-month blanking period.

Results: A total of 231 pulmonary veins (PV) were identified and 230/231 (99.6%) PVs were successfully isolated. Phrenic nerve palsy occurred in 2/60 (3.3%) patients. No other periprocedural complications occurred. Follow-up was available for 59/60 (98%) patients with a mean duration of 838 ± 67 days. A total of 43/59 (73%) patients remained in stable sinus rhythm. In 10/16 (63%) patients with ATA recurrence, a repeat procedure was performed using radiofrequency energy. The overall success rate after a maximum of two ablation procedures and a follow-up period of 838 ± 67 days was 88% (52/59) patients.

Conclusions: Patients with paroxysmal or short-persistent AF undergoing PVI using the 28-mm CB2 demonstrated a 73% 2-year single-procedure clinical success rate.

Keywords: Atrial fibrillation; Cryoballoon; Long-term follow-up; Pulmonary vein isolation.

MeSH terms

  • Aged
  • Atrial Fibrillation / surgery*
  • Catheter Ablation / methods*
  • Cryosurgery / methods*
  • Electrocardiography, Ambulatory
  • Equipment Design
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Paralysis / epidemiology
  • Paralysis / etiology
  • Phrenic Nerve / injuries
  • Pulmonary Veins / surgery*
  • Recurrence
  • Time Factors
  • Treatment Outcome