Further information: Surgical Treatment of Advanced Heart Failure (see p1461) from Cardiovascular Medicine, 3rd Edn*

In this study for advanced heart failure patients who were ineligible for heart transplantation [1], patients were randomized to receive either a pulsatile-flow left ventricular assist device (LVAD) or a continuous-flow LVAD in an effort to determine which device showed more improvement in rate of survival, quality of life, and functional capacity of patients. Conducted at 38 cities in the US, a total of 200 patients were enrolled and randomly assigned to implantation of the continuous-flow LVAD (n=134) or the pulsatile-flow LVAD (n=66) between March 2005 and May 2007. The primary end point was a composite of survival at 2 years, absence of disabling stroke (Rankin score >3), or reoperation to replace the device. Secondary endpoints were actuarial survival, frequency of adverse events, functional status, and the quality of life. In both treatment groups, the baseline characteristics were similar and included a median age of 64 years, a mean LV ejection fraction (EF) of 17%, and approximately 80% of patients received intravenous inotropic agents.

In comparison of the two devices, more patients who received the continuous-flow LVAD achieved the primary composite end point than those with pulsatile-flow LVADs (62 of 134 [46%] vs. 7 of 66 [11%]; P<0.001 hazard ratio, 0.38; 95% confidence interval, 0.27–0.54; P<0.001). Patients who received continuous-flow LVADs had superior actuarial survival rates at 2 years (58% vs. 24%, P=0.008). Quality of life and functional capacity were improved significantly in both groups, while adverse events and device replacements were less frequent in patients with continuous-flow LVADs. Therefore, the investigators in this study believe that the continuous-flow LVAD provides greater long-term benefits to the heart failure patient.

[1] Slaughter MS, Rogers JG, Milano CA, et al. Advanced heart failure treated with continuous-flow left ventricular assist device (HeartMate II). N Engl J Med 2009;361:2241-2251

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