Incidence and characteristics of complications in the setting of second-generation cryoballoon ablation: A large single-center study of 500 consecutive patients

Giacomo Mugnai, Carlo De Asmundis, Giuseppe Ciconte, Ghazala Irfan, Yukio Saitoh, Vedran Velagic, Erwin Ströker, Kristel Wauters, Burak Hünük, Pedro Brugada, Gian Battista Chierchia

Research output: Contribution to journalArticlepeer-review

Abstract

Background The second-generation cryoballoon Advance (CB-A) recently launched on the market has technical modifications designed to significantly improve procedural outcome with respect to the first-generation device. Objective The purpose of this study was to evaluate the overall incidence of complications in a large sample of patients having undergone pulmonary vein (PV) isolation with CB-A technology. Methods All consecutive patients who underwent PV isolation procedures using CB-A technology between June 2012 and February 2015 were considered. Exclusion criteria were presence of an intracavitary thrombus, uncontrolled heart failure, moderate or severe valvular disease, left atrial diameter ≥55 mm, and contraindications to general anesthesia. Results During the study period, 500 consecutive patients (67% male, age 57.6 ± 12.9 years) were enrolled. Major complications occurred in 10 patients (2.0%): vascular complications at the puncture site in 6 (1.2%), and thromboembolic events, cardiac tamponade, persisting phrenic nerve palsy, and retroperitoneal hematoma all occurred in a single patient respectively (0.2%). Phrenic nerve palsy occurred in 36 patients (7.2%) and did not revert in only 1 patient at final follow-up of 20 months. No deaths related to the procedure occurred. No predictors of major complication were found. Conclusion The present findings highlight that PV isolation using CB-A technology can be safely performed with a low incidence of adverse events. The incidence of major complications after atrial fibrillation ablation procedures using CB-A technology was 2% in our study. The most frequent complication consisted of vascular complications at the puncture site. No deaths related to the procedure occurred.

Original languageEnglish
Pages (from-to)1476-1482
Number of pages7
JournalHeart Rhythm
Volume12
Issue number7
DOIs
Publication statusPublished - Jul 1 2015

Keywords

  • Atrial fibrillation
  • Complications
  • Cryoballoon
  • Pulmonary vein isolation
  • Second-generation cryoballoon

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

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