Shinsuke Miyazaki1, Atsushi Kobori2, Yasuhiro Sasaki2, Koji Miyamoto3, Eiji Sato4, Koji Hanazawa5, Itsuo Morishima6, Yasunori Kanzaki6, Hirosuke Yamaji7, Kazuya Yamao8, Yusuke Kondo9, Masato Watanuki10, Takashi Kaneshiro11, Takashi Uchiyama12, Kohki Nakamura13, Shigeki Hiramatsu14, Jun Nakajima15, Takanori Arimoto16, Shinji Kaneko17, Norichika Osai18, Takamitsu Takagi15, Kenichi Kaseno19, Atsushi Takahashi15, Shigeto Naito13, Yoshio Kobayashi9, Hitoshi Hachiya8, Kengo Kusano3, Tetsuo Yagi4, Yoshito Iesaka8, Hiroshi Tada19. 1. Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan; Cardiovascular Center, Tsuchiura Kyodo Hospital, Tsuchiura, Ibaraki, Japan. Electronic address: mmshinsuke@gmail.com. 2. Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan. 3. Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan. 4. Department of Cardiovascular Medicine, Sendai City Hospital, Sendai, Japan. 5. Department of Cardiovascular Medicine, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan. 6. Department of Cardiology, Ogaki Municipal Hospital, Ogaki, Japan. 7. Heart Rhythm Center, Okayama Heart Clinic, Okayama, Japan. 8. Cardiovascular Center, Tsuchiura Kyodo Hospital, Tsuchiura, Ibaraki, Japan. 9. Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan. 10. Department of Cardiology, Hikone Municipal Hospital, Hikone, Japan. 11. Department of Cardiovascular Medicine, Fukushima Medical University, Fukushima, Japan. 12. Department of Cardiology, Funabashi Municipal Medical Center, Funabashi, Japan. 13. Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi, Gunma, Japan. 14. Division of Cardiology, Fukuyama Cardiovascular Hospital, Fukuyama, Japan. 15. Cardiovascular Center, Yokosuka Kyosai Hospital, Yokosuka, Japan. 16. Department of Cardiology, Pulmonology, and Nephrology, Yamagata University School of Medicine, Yamagata, Japan. 17. Department of Cardiology, Toyota Kosei Hospital, Toyota, Japan. 18. Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan. 19. Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.
Abstract
OBJECTIVES: This study sought to investigate the incidence and characteristics of the real-world safety profile of second-generation cryoballoon ablation (2nd-CBA) in Japan. BACKGROUND: Pulmonary vein isolation using second-generation cryoballoons is an accepted atrial fibrillation ablation strategy. METHODS: This multicenter observational study included 4,173 patients with atrial fibrillation (3,807 paroxysmal) who underwent a 2nd-CBA in 18 participating centers. The baseline data and details of all procedure-related complications within 3 months post-procedure in consecutive patients from the first case at each center were retrospectively collected. RESULTS: Adjunctive ablation after the pulmonary vein isolation was performed in 2,745 (65.8%) patients. Complications associated with the entire procedure were observed in 206 (4.9%) total patients, and in the multivariate analysis, the age (odds ratio: 1.015; 95% confidence interval: 1.001 to 1.030; p = 0.035) and study period were predictors. Air embolisms manifesting as ST-segment elevation and cardiac tamponade requiring drainage occurred in 63 (1.5%) and 15 (0.36%) patients, respectively. Six (0.14%) patients had strokes/transient ischemic attacks, among whom 5 underwent ablation under an interrupted anticoagulation regimen. No atrioesophageal fistulae occurred; however, 10 (0.24%) patients had symptomatic gastric hypomotility. Esophageal temperature monitoring did not reduce the incidence, and the incidence was significantly higher in patients with adjunctive posterior wall isolations or mitral isthmus ablation than those without (p = 0.004). Phrenic nerve injury occurred during the 2nd-CBA in 58 (1.4%) patients; however, all were asymptomatic and recovered within 13 months. One patient died of aspiration pneumonia. CONCLUSIONS: This study had a high safety profile of 2nd-CBA despite including the early experience and high rate of adjunctive ablation. Care should be taken for air embolisms during 2nd-CBA.
OBJECTIVES: This study sought to investigate the incidence and characteristics of the real-world safety profile of second-generation cryoballoon ablation (2nd-CBA) in Japan. BACKGROUND: Pulmonary vein isolation using second-generation cryoballoons is an accepted atrial fibrillation ablation strategy. METHODS: This multicenter observational study included 4,173 patients with atrial fibrillation (3,807 paroxysmal) who underwent a 2nd-CBA in 18 participating centers. The baseline data and details of all procedure-related complications within 3 months post-procedure in consecutive patients from the first case at each center were retrospectively collected. RESULTS: Adjunctive ablation after the pulmonary vein isolation was performed in 2,745 (65.8%) patients. Complications associated with the entire procedure were observed in 206 (4.9%) total patients, and in the multivariate analysis, the age (odds ratio: 1.015; 95% confidence interval: 1.001 to 1.030; p = 0.035) and study period were predictors. Air embolisms manifesting as ST-segment elevation and cardiac tamponade requiring drainage occurred in 63 (1.5%) and 15 (0.36%) patients, respectively. Six (0.14%) patients had strokes/transient ischemic attacks, among whom 5 underwent ablation under an interrupted anticoagulation regimen. No atrioesophageal fistulae occurred; however, 10 (0.24%) patients had symptomatic gastric hypomotility. Esophageal temperature monitoring did not reduce the incidence, and the incidence was significantly higher in patients with adjunctive posterior wall isolations or mitral isthmus ablation than those without (p = 0.004). Phrenic nerve injury occurred during the 2nd-CBA in 58 (1.4%) patients; however, all were asymptomatic and recovered within 13 months. One patient died of aspiration pneumonia. CONCLUSIONS: This study had a high safety profile of 2nd-CBA despite including the early experience and high rate of adjunctive ablation. Care should be taken for air embolisms during 2nd-CBA.