Advanced Heart Failure Treated With Continuous-Flow Left Ventricular Assist Device - HeartMate II study
The goal of this trial was to compare treatment with a continuous-flow HeartMate II ventricular assist device compared with a pulsatile-flow HeartMate XVE ventricular assist device among patients with advanced heart failure not eligible for heart transplantation.
Continuous-flow left ventricular assist device would be superior at reducing adverse events and improving functional capacity.
Patients Enrolled: 200
Mean Follow Up: 2 years
Mean Patient Age: 62 years
Mean Ejection Fraction: 17%
- Left ventricular ejection fraction <25%
- Peak oxygen consumption <14 ml per kg body weight per minute or <50% of predicted value
- New York Heart Association class III or IV for at least 45 days
- Use of an intra-aortic balloon pump for at least 7 days or inotropes for at least 14 days
- Irreversible renal, liver, or pulmonary disease
- Survival free from disabling stroke or reoperation to repair/replace the device
- Adverse events
- Functional capacity
- Quality of life
Patients with advanced heart failure who were ineligible for heart transplantation were randomized to a continuous-flow ventricular assist device (n = 134) versus a pulsatile-flow ventricular assist device (n = 66).
Aspirin was recommended for all patients. Warfarin was recommened for patients with a continuous-flow device.
Overall, 200 patients were randomized. In the continuous-flow group, the mean age was 62 years, 19% were women, 66% had ischemia as the cause of heart failure, mean cardiac index was 2.0 L/min/m2, pulmonary capillary wedge pressure was 24 mm Hg, mean serum creatinine was 1.6 mg/dl, and history of stroke was 16%. The use of an inotropic agent was 77% and intra-aortic balloon pump was 22%.
The primary outcome, survival free from stroke or reoperation to repair/replace the assist device was 46% in the continuous-flow group versus 11% in the pulsatile-flow group (p < 0.001). Disabling stroke was 11% versus 12%, reoperation to repair/replace the assist device was 10% versus 36% (p < 0.001), and death within 2 years was 33% versus 41% (p = 0.048). Rehospitalization was reduced 38% with the continuous-flow device. Functional class I or II at 12 months was 76% versus 61% (p = 0.22), respectively.
Among patients with advanced heart failure ineligible for heart transplantation, the use of a continuous-flow left ventricular assist device was beneficial. This device improved freedom from disabling stroke or reoperation for device repair/replacement. This outcome was driven by a reduced need for reoperation with the continuous-flow device. Also, rehospitalization and mortality were reduced and functional capacity was improved. This device may become an alternative for some patients as destination therapy.
Slaughter MS, Rogers JG, Milano CA, et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med 2009;Nov 17:[Epub ahead of print].
Presented by Dr. Joseph Rogers at the American Heart Association Scientific Sessions, Orlando, FL, November 17, 2009.
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Cardiac Surgery and Heart Failure, Acute Heart Failure, Heart Transplant, Mechanical Circulatory Support
Keywords: Stroke, Pulmonary Wedge Pressure, Reoperation, Oxygen Consumption, Heart-Assist Devices, Heart Failure, Stroke Volume, Creatinine, Heart Transplantation
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