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

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.

• Authors: Giacomo Mugnai, Carlo de Asmundis, Giuseppe Ciconte, Ghazala Irfan, Yukio Saitoh, Vedran Velagic, Erwin Ströker, Kristel Wauters, Burak Hünük, Pedro Brugada, Gian-Battista Chierchia
• Journal: Heart rhythm (Heart Rhythm) Vol. 12 Issue 7 Pg. 1476-82 (Jul 2015) ISSN: 1556-3871 [Electronic] United States
• PMID: 25847477 (Publication Type: Journal Article, Observational Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Topics

• Adult
• Aged
• Atrial Fibrillation (diagnosis, surgery)
• Belgium (epidemiology)
• Catheter Ablation (adverse effects, methods)
• Cryosurgery (adverse effects, methods)
• Female
• Humans
• Incidence
• Male
• Middle Aged
• Outcome Assessment, Health Care
• Peripheral Nerve Injuries (diagnosis, epidemiology, etiology)
• Phrenic Nerve (injuries)
• Postoperative Complications (diagnosis, epidemiology)
• Pulmonary Veins (surgery)
• Retrospective Studies
• Vascular System Injuries (diagnosis, epidemiology, etiology)