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

Giacomo Mugnai, Carlo de Asmundis, Giuseppe Ciconte, Ghazala Irfan, Yukio Saitoh, Vedran Velagic, Erwin Stroker, Kristel Wauters, Burak Hunuk, Pedro Brugada, Jean-Baptiste Chierchia

Research output: Contribution to journalArticlepeer-review

56 Citations (Scopus)

Abstract

BACKGROUND: The second-generation cryoballoon Advance (CB-A) has been recently launched on the market with technical modifications designed to significantly improve procedural outcome with respect to the first-generation device.

OBJECTIVE: The present study sought to evaluate the overall incidence of complications in a large sample of patients having undergone PV isolation with CB-A technology.

METHODS: All consecutive patients having undergone PV isolation procedures using CB-A technology between June 2012 and February 2015 were taken into consideration. Exclusion criteria were: presence of an intracavitary thrombus, uncontrolled heart failure, moderate or severe valvular disease, left atrium diameter ≥55 mm and contraindications to general anaesthesia.

RESULTS: During the study period 500 consecutive patients (male 67%, age 57.6±12.9 years) were enrolled. Major complications occurred in 10 patients (2.0%): specifically, vascular complications in the puncture site in 6 (1.2%); thromboembolic events, cardiac tamponade, persisting phrenic nerve palsy (PNP) and retroperitoneal hematoma all occurred in 1 patient individually (0.2%). Phrenic nerve palsy occurred in 36 patients (7.2%) and did not revert in only 1 patient at a 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 following AF ablation procedures using CB-A technology was 2% in our study. The most frequent complication consisted in vascular complications in 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
Early online date3 Apr 2015
DOIs
Publication statusPublished - Jul 2015

Bibliographical note

Copyright © 2015. Published by Elsevier Inc.

Keywords

  • Complications
  • atrial fibrillation
  • cryoballoon
  • pulmonary vein isolation
  • second generation cryoballoon

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