44%, hazard ratio 0.60, 95% confidence interval 0.37–0.96 p=0.03).Īmong patients with CHF and ventricular dysynchrony, biventricular pacing was associated with improved functional class, increased six-minute walk distance and maximal oxygen uptake, and improved quality of life. Death or worsening heart failure requiring hospitalization occurred less frequently in the CRT arm (28% vs. 39%, p<0.001) and fewer CRT patients were classified as worsened (16% vs. Using the Heart Failure Clinical Composite Outcome Measure, a significantly higher percentage of CRT patients were classified as improved (67% vs. 15%, p=0.004) were lower in CRT patients compared to controls. 15%, p=0.02) and intravenous medication (7% vs. The QRS duration was significantly lower in CRT patients compared with control (-20 vs. CRT was also associated with a significantly improved peak oxygen consumption (+1.1 vs. 9.0 points, p=0.001), time on the treadmill during exercise testing (+81 vs. +10 m, p=0.005), improved New York Heart Association (NYHA) class by at least one class (68% vs. Changes in the background medical therapy were discouraged during the six-month period of randomized controlled study.ĭevice implantation was unsuccessful in 8% of patients, and was complicated by refractory hypotension, bradycardia, or asystole in four patients (two that died) and by perforation of the coronary sinus requiring pericardiocentesis in two patients.Ĭompared with placebo, CRT was associated with a significantly improved six-minute walk distance (+39 vs. Patients who had been prescribed beta-blockers were required to be on a stable regimen for three months. Concomitant Medications:Īll patients were required to be on stable medications for one month, including an angiotensin-converting enzyme (ACE) inhibitor or ACE inhibitor substitute. These patients were then followed up at nine months, and all patients continue to be followed at six-month intervals following the double-blind period of the controlled study. The electrophysiologist served as an unblinded third party, and the heart failure specialist, the managing physician, and the patient were kept blinded to study assignment during the six-month period of pivotal study.Ĭontrol arm patients could then go into the resynchronization mode. Following successful lead placement (93%), patients underwent a predischarge randomization to the control group (no CRT, n=225) or CRT group (n=228), then underwent a six-month period of double-blinded study with follow-up at one, three, and six months. Peak oxygen consumption time on a treadmill LV ejection fraction (LVEF) and end-diastolic dimension severity of mitral regurgitation duration of QRS interval and a clinical composite response, which assigns patients to one of three response groups: improved, worsened, or unchanged Drug/Procedures Used:įollowing baseline assessment, patients underwent implant attempt within one week. Minnesota Living With Heart Failure Questionnaire Quality of Life (QOL) Measure More than two infusions per week of positive inotrope Primary Endpoints:ġ. Ventricular tachycardia associated with reversible causesġ7. Life expectancy from noncardiac disease <6 monthsġ6. Chronic atrial arrhythmia within past monthġ4. Hepatic function >3 x upper limit of normalġ2. Existing pacing system or contraindications for standard cardiac pacingĩ. Existing implantable cardioverter defibrillator (ICD) or indications for an ICDĥ. Cerebrovascular accident or transient ischemic event within the past three monthsĤ. Unstable angina, acute myocardial infarction, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within the past three monthsģ. Six-minute walking distance of ≤450 m Exclusions:Ģ. LV end-diastolic dimension at least 55 mm (mean 69 mm)ĥ. LV systolic dysfunction with an LVEF ≤35%Ĥ.
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