[A systematic review and meta-analysis on efficacy and safety of cardiac resynchronization therapy alone or in combination with implantable cardioversion defibrillation in patients with mild to severe heart failure].

OBJECTIVE: To evaluate the efficacy and safety of cardiac resynchronization therapy (CRT) alone or in combination with implantable cardioversion defibrillation (ICD) in patients with mild to severe heart failure. METHOD: Electronic searches of MEDLINE, EMBASE, CENTREN and affiliated clinical trial registration data center, US Food and Drug Administration reports, CBMdisc, VIP, and CNKI databases from establishment to Dec 2010, using the search terms "CRT, heart failure", "biventricular pacer, heart failure", "biventricular pacing, heart failure", and "biventricular pacemaker, heart failure", were performed to identify randomized controlled trials (RCTs). Meta-analysis was performed by using RevMan 5.0 software after the strict evaluation of the methodological quality of the included RCTs. RESULTS: A total of 23 trials including 8521 patients were included. In patients with New York Heart Association (NYHA) class I/II, CRT improved left ventricular ejection fraction (LVEF) [weighted mean difference (WMD) = 0.05, 95% CI 0.01 - 0.08], reduced heart failure hospitalizations [risk ratio (RR) = 0.70, 95%CI 0.61 - 0.81] and all-cause mortality (RR = 0.78, 95%CI 0.65 - 0.93) with increasing complications (RR = 1.74, 95%CI 1.42 - 2.13). In patients with NYHA class III/IV, CRT improved LVEF (WMD = 0.03, 95%CI 0.01 - 0.05), reduced both heart failure hospitalizations (RR = 0.64, 95%CI 0.55 - 0.73) and all-cause mortality (RR = 0.80, 95%CI 0.70 - 0.91) without increasing complications (RR = 1.01, 95%CI 0.91 - 1.12). Compared with ICD alone, CRT in combination with ICD significantly improved LVEF (WMD = 0.03, 95%CI 0.00 - 0.06), reduced heart failure hospitalizations (RR = 0.73, 95%CI 0.64 - 0.82) and all-cause mortality (RR = 0.82, 95%CI 0.72 - 0.95) without increasing complications (RR = 1.36, 95%CI 0.91 - 2.03) in patients with NYHA class I-IV symptoms. CONCLUSIONS: CRT offered additional benefits on top of standard medication for heart failure patients with ventricular dyssynchrony in terms of improving LV function, and reducing heart failure hospitalization and all-cause mortality, regardless of NYHA class. CRT offers also additional benefit in heart failure patients implanted with ICD. However, CRT is associated with more adverse events in patients with NYHA class I/II.