Combined CRT and ICD therapy improved median quality of life (-17.5 vs -11.0, P=0.02) and functional class (P=0.007) at 6 months compared to ICD alone in patients with advanced heart failure.
RCT (n=369)
Double-blind
Randomized
Does combined CRT and ICD therapy improve quality of life, functional class, and 6-minute walk distance in patients with NYHA class III-IV heart failure, LVEF ≤35%, and wide QRS?
In patients with advanced heart failure and wide QRS requiring an ICD, the addition of cardiac resynchronization therapy significantly improves quality of life and functional status without compromising ICD function.
p-value: p=0.02 for quality of life, 0.007 for functional class, 0.36 for 6-minute walk
CONTEXT: Cardiac resynchronization therapy (CRT) through biventricular pacing is an effective treatment for heart failure (HF) with a wide QRS; however, the outcomes of patients requiring CRT and implantable cardioverter defibrillator (ICD) therapy are unknown. OBJECTIVE: To examine the efficacy and safety of combined CRT and ICD therapy in patients with New York Heart Association (NYHA) class III or IV congestive HF despite appropriate medical management. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, parallel-controlled trial conducted from October 1, 1999, to August 31, 2001, of 369 patients with left ventricular ejection fraction of 35% or less, QRS duration of 130 ms, at high risk of life-threatening ventricular arrhythmias, and in NYHA class III (n = 328) or IV (n = 41) despite optimized medical treatment. INTERVENTIONS: Of 369 randomized patients who received devices with combined CRT and ICD capabilities, 182 were controls (ICD activated, CRT off) and 187 were in the CRT group (ICD activated, CRT on). MAIN OUTCOME MEASURES: The primary double-blind study end points were changes between baseline and 6 months in quality of life, functional class, and distance covered during a 6-minute walk. Additional outcome measures included changes in exercise capacity, plasma neurohormones, left ventricular function, and overall HF status. Survival, incidence of ventricular arrhythmias, and rates of hospitalization were also compared. RESULTS: At 6 months, patients assigned to CRT had a greater improvement in median (95% confidence interval) quality of life score (-17.5 -21 to -14 vs -11.0 -16 to -7, P =.02) and functional class (-1 -1 to -1 vs 0 -1 to 0, P =.007) than controls but were no different in the change in distance walked in 6 minutes (55 m 44-79 vs 53 m 43-75, P =.36). Peak oxygen consumption increased by 1.1 mL/kg per minute (0.7-1.6) in the CRT group vs 0.1 mL/kg per minute (-0.1 to 0.8) in controls (P =.04), although treadmill exercise duration increased by 56 seconds (30-79) in the CRT group and decreased by 11 seconds (-55 to 12) in controls (P<.001). No significant differences were observed in changes in left ventricular size or function, overall HF status, survival, and rates of hospitalization. No proarrhythmia was observed and arrhythmia termination capabilities were not impaired. CONCLUSIONS: Cardiac resynchronization improved quality of life, functional status, and exercise capacity in patients with moderate to severe HF, a wide QRS interval, and life-threatening arrhythmias. These improvements occurred in the context of underlying appropriate medical management without proarrhythmia or compromised ICD function.
Young et al. (Wed,) conducted a rct in Advanced chronic heart failure (n=369). Combined cardiac resynchronization and implantable cardioverter defibrillator (CRT on) vs. ICD activated, CRT off was evaluated on Changes between baseline and 6 months in quality of life, functional class, and distance covered during a 6-minute walk (p=0.02 for quality of life, 0.007 for functional class, 0.36 for 6-minute walk). Combined CRT and ICD therapy improved median quality of life (-17.5 vs -11.0, P=0.02) and functional class (P=0.007) at 6 months compared to ICD alone in patients with advanced heart failure.