Cardiac resynchronization in chronic heart failure - PubMed (original) (raw)

Clinical Trial

. 2002 Jun 13;346(24):1845-53.

doi: 10.1056/NEJMoa013168.

Westby G Fisher, Andrew L Smith, David B Delurgio, Angel R Leon, Evan Loh, Dusan Z Kocovic, Milton Packer, Alfredo L Clavell, David L Hayes, Myrvin Ellestad, Robin J Trupp, Jackie Underwood, Faith Pickering, Cindy Truex, Peggy McAtee, John Messenger; MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation

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Clinical Trial

Cardiac resynchronization in chronic heart failure

William T Abraham et al. N Engl J Med. 2002.

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Abstract

Background: Previous studies have suggested that cardiac resynchronization achieved through atrial-synchronized biventricular pacing produces clinical benefits in patients with heart failure who have an intraventricular conduction delay. We conducted a double-blind trial to evaluate this therapeutic approach.

Methods: Four hundred fifty-three patients with moderate-to-severe symptoms of heart failure associated with an ejection fraction of 35 percent or less and a QRS interval of 130 msec or more were randomly assigned to a cardiac-resynchronization group (228 patients) or to a control group (225 patients) for six months, while conventional therapy for heart failure was maintained. The primary end points were the New York Heart Association functional class, quality of life, and the distance walked in six minutes.

Results: As compared with the control group, patients assigned to cardiac resynchronization experienced an improvement in the distance walked in six minutes (+39 vs. +10 m, P=0.005), functional class (P<0.001), quality of life (-18.0 vs. -9.0 points, P= 0.001), time on the treadmill during exercise testing (+81 vs. +19 sec, P=0.001), and ejection fraction (+4.6 percent vs. -0.2 percent, P<0.001). In addition, fewer patients in the group assigned to cardiac resynchronization than control patients required hospitalization (8 percent vs. 15 percent) or intravenous medications (7 percent vs. 15 percent) for the treatment of heart failure (P<0.05 for both comparisons). Implantation of the device was unsuccessful in 8 percent of patients and was complicated by refractory hypotension, bradycardia, or asystole in four patients (two of whom died) and by perforation of the coronary sinus requiring pericardiocentesis in two others.

Conclusions: Cardiac resynchronization results in significant clinical improvement in patients who have moderate-to-severe heart failure and an intraventricular conduction delay.

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