Published online before print October 25, 2004, doi: 10.1161/01.CIR.0000146336.92331.D1
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(Circulation. 2004;110:2864-2868.)
© 2004 American Heart Association, Inc.
Heart Failure |
Effects of Cardiac Resynchronization on Disease Progression in Patients With Left Ventricular Systolic Dysfunction, an Indication for an Implantable Cardioverter-Defibrillator, and Mildly Symptomatic Chronic Heart Failure
From the Ohio State University Heart Center, Columbus (W.T.A.); Cleveland Clinic Foundation, Cleveland, Ohio (J.B.Y.); Emory University-Crawford Long Hospital, Atlanta, Ga (A.R.L.); St Paul Heart Clinic, St Paul, Minn (A.J.B., S.A.); Baylor Heart and Vascular Hospital, Dallas, Tex (S.A.H., K.R.W.); Harper University Hospital-Wayne State University, Detroit, Mich (J.B.O., R.L.); and Stanford University, Palo Alto, Calif (L.B.L., J.S.S.).
Correspondence to William T. Abraham, MD, Ohio State University Heart Center, Division of Cardiovascular Medicine, 473 W 12th Ave, Room 110P DHLRI, Columbus, OH 43210-1252. E-mail abraham-1{at}medctr.osu.edu
Received February 11, 2004; de novo received June 6, 2004; accepted July 21, 2004.
Background— The effects of cardiac resynchronization therapy (CRT) in patients with mildly symptomatic heart failure have not been fully elucidated.
Methods and Results— The Multicenter InSync ICD Randomized Clinical Evaluation II (MIRACLE ICD II) was a randomized, double-blind, parallel-controlled clinical trial of CRT in NYHA class II heart failure patients on optimal medical therapy with a left ventricular (LV) ejection fraction 
35%, a QRS 
130 ms, and a class I indication for an ICD. One hundred eighty-six patients were randomized: 101 to the control group (ICD activated, CRT off) and 85 to the CRT group (ICD activated, CRT on). End points included peak 
O2, E/CO2, NYHA class, quality of life, 6-minute walk distance, LV volumes and ejection fraction, and composite clinical response. Compared with the control group at 6 months, no significant improvement was noted in peak O2, yet there were significant improvements in ventricular remodeling indexes, specifically LV diastolic and systolic volumes (P=0.04 and P=0.01, respectively), and LV ejection fraction (P=0.02). CRT patients showed statistically significant improvement in E/CO2 (P=0.01), NYHA class (P=0.05), and clinical composite response (P=0.01). No significant differences were noted in 6-minute walk distance or quality of life scores.
Conclusions— In patients with mild heart failure symptoms on optimal medical therapy with a wide QRS complex and an ICD indication, CRT did not alter exercise capacity but did result in significant improvement in cardiac structure and function and composite clinical response over 6 months.
Key Words: defibrillators, implantable • exercise test • heart failure • pacing • ventricular remodeling
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