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.
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: Jesus M Paylos; Aracelis Morales; Luis Azcona; Marisol Paradela; Raquel Yagüe; Fernando Gómez-Guijarro; Lourdes Lacal; R N Clara Ferrero; Octavio Rodríguez Journal: J Atr Fibrillation Date: 2016-04-30
Authors: Jesus M Paylos; Luis Azcona; Lourdes Lacal; Marisol Paradela; Carmen Cilleros; Ildefonso Del-Campo; Clara Ferrero Rn Carlos Martínez; Aracelis Morales Journal: J Atr Fibrillation Date: 2016-04-30
Authors: Giacomo Mugnai; Carlo de Asmundis; Saverio Iacopino; Erwin Ströker; Massimo Longobardi; Maria Claudia Negro; Valentina De Regibus; Hugo Enrique Coutino-Moreno; Ken Takarada; Rajin Choudhury; Juan Pablo Abugattas de Torres; Cesare Storti; Pedro Brugada; Gian-Battista Chierchia Journal: J Interv Card Electrophysiol Date: 2018-02-14 Impact factor: 1.900
Authors: Hugo Enrique Coutiño; Carlo de Asmundis; Giacomo Mugnai; Darragh Moran; Valentina De Regibus; Erwin Ströker; Ken Takarada; Diego Ruggiero; Rajin Choudhury; Stefan Beckers; Carla Van Gompel; Jan Poelaert; Saverio Iacopino; Pasquale Filannino; Pedro Brugada; Gian-Battista Chierchia Journal: J Interv Card Electrophysiol Date: 2016-08-25 Impact factor: 1.900