Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial.
BACKGROUND
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.


METHODS
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.


METHODS
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).


METHODS
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
James B
JB
Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. youngj@ccf.org
Abraham
William T
WT
Smith
Andrew L
AL
Leon
Angel R
AR
Lieberman
Randy
R
Wilkoff
Bruce
B
Canby
Robert C
RC
Schroeder
John S
JS
Liem
L Bing
LB
Hall
Shelley
S
Wheelan
Kevin
K
D000368:Aged; D002304:Cardiac Pacing, Artificial; D018592:Cross-Over Studies; D017147:Defibrillators, Implantable; D004311:Double-Blind Method; D004554:Electric Countershock; D017079:Exercise Tolerance; D005260:Female; D006333:Heart Failure / Q000503:physiopathology / Q000628:therapy*; D006334:Heart Function Tests; D006801:Humans; D008297:Male; D010138:Pacemaker, Artificial; D011183:Postoperative Complications; D011788:Quality of Life; D016019:Survival Analysis; D017180:Tachycardia, Ventricular; D018487:Ventricular Dysfunction, Left; D014693:Ventricular Fibrillation