PMID- 12771115 OWN - NLM STAT- MEDLINE DCOM- 20030612 LR - 20220331 IS - 0098-7484 (Print) IS - 0098-7484 (Linking) VI - 289 IP - 20 DP - 2003 May 28 TI - Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. PG - 2685-94 AB - 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. FAU - Young, James B AU - Young JB AD - Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. youngj@ccf.org FAU - Abraham, William T AU - Abraham WT FAU - Smith, Andrew L AU - Smith AL FAU - Leon, Angel R AU - Leon AR FAU - Lieberman, Randy AU - Lieberman R FAU - Wilkoff, Bruce AU - Wilkoff B FAU - Canby, Robert C AU - Canby RC FAU - Schroeder, John S AU - Schroeder JS FAU - Liem, L Bing AU - Liem LB FAU - Hall, Shelley AU - Hall S FAU - Wheelan, Kevin AU - Wheelan K CN - Multicenter InSync ICD Randomized Clinical Evaluation (MIRACLE ICD) Trial Investigators LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - JAMA JT - JAMA JID - 7501160 SB - IM CIN - JAMA. 2003 May 28;289(20):2719-21. PMID: 12771120 MH - Aged MH - *Cardiac Pacing, Artificial MH - Cross-Over Studies MH - *Defibrillators, Implantable MH - Double-Blind Method MH - *Electric Countershock MH - Exercise Tolerance MH - Female MH - Heart Failure/physiopathology/*therapy MH - Heart Function Tests MH - Humans MH - Male MH - *Pacemaker, Artificial MH - Postoperative Complications MH - Quality of Life MH - Survival Analysis MH - Tachycardia, Ventricular MH - Ventricular Dysfunction, Left MH - Ventricular Fibrillation EDAT- 2003/05/29 05:00 MHDA- 2003/06/13 05:00 CRDT- 2003/05/29 05:00 PHST- 2003/05/29 05:00 [pubmed] PHST- 2003/06/13 05:00 [medline] PHST- 2003/05/29 05:00 [entrez] AID - 289/20/2685 [pii] AID - 10.1001/jama.289.20.2685 [doi] PST - ppublish SO - JAMA. 2003 May 28;289(20):2685-94. doi: 10.1001/jama.289.20.2685.