title: 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.
  
  
  CONCLUSIONS
  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.affiliation: Heart Rhythm Management Centre, UZ Brussel-VUB, Brussels, Belgium. Electronic address: mugnai.giacomo@gmail.com.
authors.forename: Giacomo
authors.initials: G
authors.lastname: Mugnai
authors.affiliation: Heart Rhythm Management Centre, UZ Brussel-VUB, Brussels, Belgium.
authors.forename: Carlo
authors.initials: C
authors.lastname: de Asmundis
authors.affiliation: Heart Rhythm Management Centre, UZ Brussel-VUB, Brussels, Belgium.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Ciconte
authors.affiliation: Heart Rhythm Management Centre, UZ Brussel-VUB, Brussels, Belgium.
authors.forename: Ghazala
authors.initials: G
authors.lastname: Irfan
authors.affiliation: Heart Rhythm Management Centre, UZ Brussel-VUB, Brussels, Belgium.
authors.forename: Yukio
authors.initials: Y
authors.lastname: Saitoh
authors.affiliation: Heart Rhythm Management Centre, UZ Brussel-VUB, Brussels, Belgium.
authors.forename: Vedran
authors.initials: V
authors.lastname: Velagic
authors.affiliation: Heart Rhythm Management Centre, UZ Brussel-VUB, Brussels, Belgium.
authors.forename: Erwin
authors.initials: E
authors.lastname: Ströker
authors.affiliation: Heart Rhythm Management Centre, UZ Brussel-VUB, Brussels, Belgium.
authors.forename: Kristel
authors.initials: K
authors.lastname: Wauters
authors.affiliation: Heart Rhythm Management Centre, UZ Brussel-VUB, Brussels, Belgium.
authors.forename: Burak
authors.initials: B
authors.lastname: Hünük
authors.affiliation: Heart Rhythm Management Centre, UZ Brussel-VUB, Brussels, Belgium.
authors.forename: Pedro
authors.initials: P
authors.lastname: Brugada
authors.affiliation: Heart Rhythm Management Centre, UZ Brussel-VUB, Brussels, Belgium.
authors.forename: Gian-Battista
authors.initials: GB
authors.lastname: Chierchia
mesh_terms: D000328:Adult; D000368:Aged; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000601:surgery; D001530:Belgium / Q000453:epidemiology; D017115:Catheter Ablation / Q000009:adverse effects / Q000379:methods; D003452:Cryosurgery / Q000009:adverse effects / Q000379:methods; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D059348:Peripheral Nerve Injuries / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology; D010791:Phrenic Nerve / Q000293:injuries; D011183:Postoperative Complications / Q000175:diagnosis / Q000453:epidemiology; D011667:Pulmonary Veins / Q000601:surgery; D012189:Retrospective Studies; D057772:Vascular System Injuries / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology
keywords: Atrial fibrillation; Complications; Cryoballoon; Pulmonary vein isolation; Second-generation cryoballoon.