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Submitted on February 11, 2004
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.). * To whom correspondence should be addressed. E-mail: abraham-1{at}medctr.osu.edu.
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 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.
Revised on June 6, 2004
Accepted on July 21, 2004
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
William T. Abraham MD*,
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 VO2, VE/VCO2, 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 VO2, 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 VE/VCO2 (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.
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