Roderick Tung1,2,3, Yumei Xue2, Minglong Chen4, Chenyang Jiang5, Dalise Y Shatz1, Stephanie A Besser1, Hongde Hu6, Fa-Po Chung7, Shiro Nakahara8, Young-Hoon Kim9, Kazuhiro Satomi, Lishui Shen10, Er'peng Liang10, Hongtao Liao2, Kai Gu4, Ruhong Jiang5, Jian Jiang6, Yuichi Hori8, Jong-Il Choi9, Akiko Ueda11, Yuki Komatsu12, Shuichiro Kazawa13, Kyoko Soejima14, Shih-Ann Chen15, Akihiko Nogami12, Yan Yao10. 1. The University of Chicago, Center for Arrhythmia Care, Pritzker School of Medicine, IL (R.T., D.Y.S., S.A.B.). 2. Guangdong Provincial People's Hospital, China (R.T., Y.X., H.L.). 3. Department of Cardiology, Sir Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China (R.T.). 4. The First Affiliated Hospital of Nanjing Medical University, China (M.C., K.G.). 5. Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China (C.J., R.J.). 6. Department of Cardiology, West China Hospital, Sichuan University, Chengdu (H.H., J.J.). 7. Taipei Veterans General Hospital, National Yang Ming Chiao Tung University, Taiwan (F.-P.C.). 8. Dokkyo Medical University Saitama Medical Center, Japan (S.N., Y.H.). 9. Division of Cardiology, Department of Internal Medicine, Korea University Medical Center, Seoul, Korea (Y.-H.K., J.-I.C.). 10. Fuwai Hospital, Arrhythmia Center, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing (L.S., E.L., Y.Y.). 11. Division of Advanced Arrhythmia Management, Kyorin University Hospital, Japan (A.U.). 12. Department of Cardiology, Faculty of Medicine, University of Tsukuba, Japan (Y.K., A.N.). 13. Tokyo Medical University, Japan (S.K.). 14. Department of Cardiovascular Medicine, Kyorin University Hospital, Japan (K.S.). 15. Cardiovascular Center, Taichung Veterans General Hospital, Taichung, Taiwan (S.-A.C.).
Abstract
BACKGROUND: Catheter ablation as first-line therapy for ventricular tachycardia (VT) at the time of implantable cardioverter defibrillator (ICD) implantation has not been adopted into clinical guidelines. Also, there is an unmet clinical need to prospectively examine the role of VT ablation in patients with nonischemic cardiomyopathy, an increasingly prevalent population that is referred for advanced therapies globally. METHODS: We conducted an international, multicenter, randomized controlled trial enrolling 180 patients with cardiomyopathy and monomorphic VT with an indication for ICD implantation to assess the role of early, first-line ablation therapy. A total of 121 patients were randomly assigned (1:1) to ablation plus an ICD versus conventional medical therapy plus an ICD. Patients who refused ICD (n=47) were followed in a prospective registry after stand-alone ablation treatment. The primary outcome was a composite end point of VT recurrence, cardiovascular hospitalization, or death. RESULTS: Randomly assigned patients had a mean age of 55 years (interquartile range, 46-64) and left ventricular ejection fraction of 40% (interquartile range, 30%-49%); 81% were male. The underlying heart disease was ischemic cardiomyopathy in 35%, nonischemic cardiomyopathy in 30%, and arrhythmogenic cardiomyopathy in 35%. Ablation was performed a median of 2 days before ICD implantation (interquartile range, 5 days before to 14 days after). At 31 months, the primary outcome occurred in 49.3% of the ablation group and 65.5% in the control group (hazard ratio, 0.58 [95% CI, 0.35-0.96]; P=0.04). The observed difference was driven by a reduction in VT recurrence in the ablation arm (hazard ratio, 0.51 [95%CI, 0.29-0.90]; P=0.02). A statistically significant reduction in both ICD shocks (10.0% versus 24.6%; P=0.03) and antitachycardia pacing (16.2% versus 32.8%; P=0.04) was observed in patients who underwent ablation compared with control. No differences in cardiovascular hospitalization (32.0% versus. 33.7%; hazard ratio, 0.82 [95% CI, 0.43-1.56]; P=0.55) or mortality (8.9% versus 8.8%; hazard ratio, 1.40 [95% CI, 0.38-5.22]; P=0.62]) were observed. Ablation-related complications occurred in 8.3% of patients. CONCLUSIONS: Among patients with cardiomyopathy of varied causes, early catheter ablation performed at the time of ICD implantation significantly reduced the composite primary outcome of VT recurrence, cardiovascular hospitalization, or death. These findings were driven by a reduction in ICD therapies. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02848781.
BACKGROUND: Catheter ablation as first-line therapy for ventricular tachycardia (VT) at the time of implantable cardioverter defibrillator (ICD) implantation has not been adopted into clinical guidelines. Also, there is an unmet clinical need to prospectively examine the role of VT ablation in patients with nonischemic cardiomyopathy, an increasingly prevalent population that is referred for advanced therapies globally. METHODS: We conducted an international, multicenter, randomized controlled trial enrolling 180 patients with cardiomyopathy and monomorphic VT with an indication for ICD implantation to assess the role of early, first-line ablation therapy. A total of 121 patients were randomly assigned (1:1) to ablation plus an ICD versus conventional medical therapy plus an ICD. Patients who refused ICD (n=47) were followed in a prospective registry after stand-alone ablation treatment. The primary outcome was a composite end point of VT recurrence, cardiovascular hospitalization, or death. RESULTS: Randomly assigned patients had a mean age of 55 years (interquartile range, 46-64) and left ventricular ejection fraction of 40% (interquartile range, 30%-49%); 81% were male. The underlying heart disease was ischemic cardiomyopathy in 35%, nonischemic cardiomyopathy in 30%, and arrhythmogenic cardiomyopathy in 35%. Ablation was performed a median of 2 days before ICD implantation (interquartile range, 5 days before to 14 days after). At 31 months, the primary outcome occurred in 49.3% of the ablation group and 65.5% in the control group (hazard ratio, 0.58 [95% CI, 0.35-0.96]; P=0.04). The observed difference was driven by a reduction in VT recurrence in the ablation arm (hazard ratio, 0.51 [95%CI, 0.29-0.90]; P=0.02). A statistically significant reduction in both ICD shocks (10.0% versus 24.6%; P=0.03) and antitachycardia pacing (16.2% versus 32.8%; P=0.04) was observed in patients who underwent ablation compared with control. No differences in cardiovascular hospitalization (32.0% versus. 33.7%; hazard ratio, 0.82 [95% CI, 0.43-1.56]; P=0.55) or mortality (8.9% versus 8.8%; hazard ratio, 1.40 [95% CI, 0.38-5.22]; P=0.62]) were observed. Ablation-related complications occurred in 8.3% of patients. CONCLUSIONS: Among patients with cardiomyopathy of varied causes, early catheter ablation performed at the time of ICD implantation significantly reduced the composite primary outcome of VT recurrence, cardiovascular hospitalization, or death. These findings were driven by a reduction in ICD therapies. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02848781.
Authors: Ivaylo Chakarov; Julian Mueller; Elena Ene; Arthur Berkovitz; Kai Sonne; Karin Nentwich; Tobias Schupp; Michael Behnes; Thomas Deneke Journal: J Clin Med Date: 2022-07-11 Impact factor: 4.964