OBJECTIVES:Totally epicardial cardiac resynchronization therapy (CRT) is a novel treatment modality for patients with heart failure (HF) and systolic dyssynchrony undergoing coronary artery bypass grafting (CABG). In this study, we have prospectively evaluated the long-term outcomes of totally epicardial CRT. METHODS:Between September 2007 and June 2009, one hundred and seventy-eight patients were randomly assigned to the CABG alone group (n = 87) and CABG with concomitant epicardial CRT implantation (n = 91). The primary end-point of the study was all-cause mortality in the two groups between the day of surgery and 13 August 2013 (common closing date). The secondary outcomes included mode of death, adverse cardiac events and lead performance. RESULTS: The mean follow-up was 55 ± 10.7 months. According to per-protocol analysis with treatment as a time-dependent variable to account for conversion from CABG to CABG + CRT, there were 24 deaths (35.8%) in the CABG group and 17 deaths (15.3%) in the CABG + CRT group. When compared with CABG alone, concomitant CRT was associated with reduced risk of both all-cause mortality [hazard ratio (HR) 0.43, 95% confidence interval (CI) 0.23-0.84, P = 0.012] and cardiac death (HR 0.39, 95% CI 0.21-0.72, P = 0.002). Eleven (12.6%) sudden deaths were observed in the CABG group in comparison with 4 (4.4%) in the CABG + CRT group (P = 0.048). Hospital readmission was required for 9 (9.9%) patients in CABG + CRT group and for 25 (28.7%) patients in the CABG group (P = 0.001). There were 4 (1.5%) epicardial lead failures. CONCLUSIONS: The results of our study suggest that the procedure of CABG and totally epicardial CRT system implantation is safe and significantly improves the survival of patients with HF and dyssynchrony during long-term follow-up. CLINICAL TRIAL REGISTRATION: NCT 00846001 (http://www.clinicaltrials.gov).
RCT Entities:
OBJECTIVES: Totally epicardial cardiac resynchronization therapy (CRT) is a novel treatment modality for patients with heart failure (HF) and systolic dyssynchrony undergoing coronary artery bypass grafting (CABG). In this study, we have prospectively evaluated the long-term outcomes of totally epicardial CRT. METHODS: Between September 2007 and June 2009, one hundred and seventy-eight patients were randomly assigned to the CABG alone group (n = 87) and CABG with concomitant epicardial CRT implantation (n = 91). The primary end-point of the study was all-cause mortality in the two groups between the day of surgery and 13 August 2013 (common closing date). The secondary outcomes included mode of death, adverse cardiac events and lead performance. RESULTS: The mean follow-up was 55 ± 10.7 months. According to per-protocol analysis with treatment as a time-dependent variable to account for conversion from CABG to CABG + CRT, there were 24 deaths (35.8%) in the CABG group and 17 deaths (15.3%) in the CABG + CRT group. When compared with CABG alone, concomitant CRT was associated with reduced risk of both all-cause mortality [hazard ratio (HR) 0.43, 95% confidence interval (CI) 0.23-0.84, P = 0.012] and cardiac death (HR 0.39, 95% CI 0.21-0.72, P = 0.002). Eleven (12.6%) sudden deaths were observed in the CABG group in comparison with 4 (4.4%) in the CABG + CRT group (P = 0.048). Hospital readmission was required for 9 (9.9%) patients in CABG + CRT group and for 25 (28.7%) patients in the CABG group (P = 0.001). There were 4 (1.5%) epicardial lead failures. CONCLUSIONS: The results of our study suggest that the procedure of CABG and totally epicardial CRT system implantation is safe and significantly improves the survival of patients with HF and dyssynchrony during long-term follow-up. CLINICAL TRIAL REGISTRATION: NCT 00846001 (http://www.clinicaltrials.gov).
Authors: Yitschak Biton; Jason Costa; Wojciech Zareba; Jayson R Baman; Ilan Goldenberg; Scott McNitt; Scott D Solomon; Bronislava Polonsky; Valentina Kutyifa Journal: Clin Cardiol Date: 2018-10 Impact factor: 2.882