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Left ventricular assist devices reduced the risk for death and increased 1-year survival in chronic end-stage heart failure

Joseph S. Alpert, MD
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*See Glossary.

†Information provided by author.

‡Rose EA, Moskowitz AJ, Packer M, et al. Ann Thorac Surg. 1999; 67:723-30.

Sources of funding: In part, National Heart, Lung, and Blood Institute and Thoratec Corporation.

For correspondence: International Center for Health Outcomes and Innovation Research, Columbia University, New York, NY, USA.

Ann Intern Med. 2002;136(3):88. doi:10.7326/ACPJC-2002-136-3-088
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Question: In patients with chronic end-stage heart failure who are ineligible for a cardiac transplant, are left ventricular assist devices (LVADs) as effective as optimal medical management for long-term use?

Design: Randomized {allocation concealed*}†, unblinded,* controlled trial with 2-year follow-up.

Setting: 20 cardiac transplantation centers in the United States.

Patients: 129 patients (mean age 67 y, 80% men) who had chronic end-stage heart failure and contraindications for a heart transplant; a left ventricular ejection fraction of ≤ 25%; and symptoms of New York Heart Association (NYHA) class-IV heart failure for ≥ 60 days and a peak oxygen consumption of ≤ 14 mL/kg of body weight/min or a continued need for intravenous inotropic therapy because of symptomatic hypotension, decreasing renal function, or worsening pulmonary congestion. After 18 months of enrollment, entry criteria were relaxed to include patients with symptoms of NYHA class-III or -IV heart failure for ≥ 28 days and ≥ 14 days of support with an intra-aortic balloon pump or with a dependence on intravenous inotropic agents with 2 failed weaning attempts. Exclusion criteria are described elsewhere.‡ {Follow-up was 100%.}†

Intervention: Patients were allocated to an LVAD (n = 68) implanted into either a preperitoneal pocket or the peritoneal cavity or to optimal medical management (n = 61).

Main outcome measure: All-cause mortality for the 2-year observation period.

Main results: Analysis was by intention to treat and used Kaplan-Meier (KM) survival curves. The risk for death for the 2-year observation period was lower in the LVAD group than in the medical group (hazard ratio 0.52, 95% CI 0.34 to 0.78). 1-year survival was higher in the LVAD group than in the medi-cal group (KM estimates of survival 52% vs 25%, P = 0.002), but groups did not differ for 2-year survival (KM estimates of survival 23% vs 8%, P = 0.09).

Conclusions: In patients with chronic end-stage heart failure who are ineligible for a cardiac transplant, left ventricular assist devices (LVADs) reduced the risk for death more than did optimal medical management. LVADs increased 1-year survival, but groups did not differ for 2-year survival.





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