August 30, 2007 | Leslie W. Miller, M.D., Francis D. Pagani, M.D., Ph.D., Stuart D. Russell, M.D., Ranjit John, M.D., Andrew J. Boyle, M.D., Keith D. Aaronson, M.D., John V. Conte, M.D., Yoshifumi Naka, M.D., Donna Mancini, M.D., Reynolds M. Delgado, M.D., Thomas E. MacGillivray, M.D., David J. Farrar, Ph.D., and O.H. Frazier, M.D., for the HeartMate II Clinical Investigators
A continuous-flow left ventricular assist device (LVAD) was evaluated in 133 patients awaiting heart transplantation. The device provided effective hemodynamic support for at least 6 months, with improved functional status and quality of life. At 180 days, 75% of patients had undergone transplantation, cardiac recovery, or continued mechanical support while remaining eligible for transplantation. The median duration of support was 126 days, with survival rates of 75% at 6 months and 68% at 12 months. Functional status and quality of life improved significantly, as measured by the New York Heart Association class and 6-minute walk test. Major adverse events included postoperative bleeding, stroke, right heart failure, and percutaneous lead infection. Pump thrombosis occurred in two patients. Continuous-flow pumps offer advantages over pulsatile devices, including smaller size, less noise, and greater mechanical reliability. However, they also pose challenges, such as the risk of pump thrombosis and the need for higher antithrombotic therapy. The study found that adverse events per patient-year with the continuous-flow pump were lower compared to pulsatile-flow pumps. The results suggest that continuous-flow LVADs can be an effective bridge to heart transplantation, with improved outcomes for patients awaiting transplantation. The study was conducted at 26 centers in the United States and was supervised by Thoratec. The findings indicate that continuous-flow LVADs can provide effective mechanical circulatory support for patients with refractory heart failure. The study also highlights the importance of patient selection and the need for further research to optimize device use and minimize complications.A continuous-flow left ventricular assist device (LVAD) was evaluated in 133 patients awaiting heart transplantation. The device provided effective hemodynamic support for at least 6 months, with improved functional status and quality of life. At 180 days, 75% of patients had undergone transplantation, cardiac recovery, or continued mechanical support while remaining eligible for transplantation. The median duration of support was 126 days, with survival rates of 75% at 6 months and 68% at 12 months. Functional status and quality of life improved significantly, as measured by the New York Heart Association class and 6-minute walk test. Major adverse events included postoperative bleeding, stroke, right heart failure, and percutaneous lead infection. Pump thrombosis occurred in two patients. Continuous-flow pumps offer advantages over pulsatile devices, including smaller size, less noise, and greater mechanical reliability. However, they also pose challenges, such as the risk of pump thrombosis and the need for higher antithrombotic therapy. The study found that adverse events per patient-year with the continuous-flow pump were lower compared to pulsatile-flow pumps. The results suggest that continuous-flow LVADs can be an effective bridge to heart transplantation, with improved outcomes for patients awaiting transplantation. The study was conducted at 26 centers in the United States and was supervised by Thoratec. The findings indicate that continuous-flow LVADs can provide effective mechanical circulatory support for patients with refractory heart failure. The study also highlights the importance of patient selection and the need for further research to optimize device use and minimize complications.