Mechanical circulatory support in the surgical treatment of heart failure

BACKGROUND: Long term mechanical circulatory support is applied with increasing frequency and progressively improving results to patients with end stage chronic heart failure refractory to medical treatment. Improved patient selection, device technology and patient management have contributed to improving results. The poor preoperative clinical profile has been related to increased morbidity and mortality and gaps in evidence of usefulness of support. The hypotheses of the study are that long term left ventricular support by continuous flow LVADs in selected patients with end stage chronic heart failure is useful and effective, offering better results that those achieved with medical treatment, and that the outcome of long term left ventricular support with the Jarvik 2000 LVAD is not inferior to the outcome of long term left ventricular support with the widely applied HeartMate II LVAD (both being continuous axial flow 2nd generation LVADs). The primary goal of the study is to contribute evidence supporting these hypotheses. PATIENTS AND METHODS: All patients who received implantable ventricular assist devices in an approved non transplant mechanical circulatory support centre, between March 2006 and July 2010, were enrolled into the study (n=18). Data was prospectively collected in accordance with the standard practice of prospective studies and the INTERMACS Registry. All patients have been followed-up until the end point of death. Patients were not censored after device removal for recovery. Long term support has been applied by continuous flow left ventricular assist devices (Levacor LVAD n=2, Jarvik LVAD n=13), biventricular assist devices (Jarvik BVAD, n=2), while short term right ventricular support with a continuous flow device was applied in one patient who received pulsatile long term left ventricular support (Novacor LVAD and Levitronix RVAD, n=1) RESULTS: The overall observed 1 year survival was 72.22%, the estimated (Kaplan – Meier) 2 and 3 year survival was 63.5%. Better results were noted in left ventricular that in biventricular support. In 3 patients the device was removed after recovery. All the other patients received destination therapy. In the subgroup of patients who received long term left ventricular support by the Jarvik 2000 LVAD mainly as destination therapy the 1 year observed and estimated survival was 84.6%, the 2 and 3 year estimated survival was 76.2%. Statistical analysis showed the non inferiority of the results of left ventricular support by the Jarvik 2000 LVAD in comparison to the results of historic control patient groups who received long term left ventricular support by a second generation continuous flow LVAD (HeartMate II). Comparison to historic control patient groups who received medical treatment showed the usefulness and effectiveness of support. CONCLUSIONS: Application of long term left ventricular support in selected patients with end stage chronic heart failure and preserved right ventricular function is useful offering better survival than medical treatment. Long term left ventricular support by the Jarvik 2000 LVAD appears useful and effective yielding similar or superior results to those achieved with the application of another widely applied 2nd generation continuous flow LVAD.BACKGROUND: Long term mechanical circulatory support is applied with increasing frequency and progressively improving results to patients with end stage chronic heart failure refractory to medical treatment. Improved patient selection, device technology and patient management have contributed to improving results. The poor preoperative clinical profile has been related to increased morbidity and mortality and gaps in evidence of usefulness of support. The hypotheses of the study are that long term left ventricular support by continuous flow LVADs in selected patients with end stage chronic heart failure is useful and effective, offering better results that those achieved with medical treatment, and that the outcome of long term left ventricular support with the Jarvik 2000 LVAD is not inferior to the outcome of long term left ventricular support with the widely applied HeartMate II LVAD (both being continuous axial flow 2nd generation LVADs). The primary goal of the study is to contribute evidence supporting these hypotheses.PATIENTS AND METHODS: All patients who received implantable ventricular assist devices in an approved non transplant mechanical circulatory support centre, between March 2006 and July 2010, were enrolled into the study (n=18). Data was prospectively collected in accordance with the standard practice of prospective studies and the INTERMACS Registry. All patients have been followed-up until the end point of death. Patients were not censored after device removal for recovery. Long term support has been applied by continuous flow left ventricular assist devices (Levacor LVAD n=2, Jarvik LVAD n=13), biventricular assist devices (Jarvik BVAD, n=2), while short term right ventricular support with a continuous flow device was applied in one patient who received pulsatile long term left ventricular support (Novacor LVAD and Levitronix RVAD, n=1)RESULTS: The overall observed 1 year survival was 72.22%, the estimated (Kaplan – Meier) 2 and 3 year survival was 63.5%. Better results were noted in left ventricular that in biventricular support. In 3 patients the device was removed after recovery. All the other patients received destination therapy. In the subgroup of patients who received long term left ventricular support by the Jarvik 2000 LVAD mainly as destination therapy the 1 year observed and estimated survival was 84.6%, the 2 and 3 year estimated survival was 76.2%.220Statistical analysis showed the non inferiority of the results of left ventricular support by the Jarvik 2000 LVAD in comparison to the results of historic control patient groups who received long term left ventricular support by a second generation continuous flow LVAD (HeartMate II). Comparison to historic control patient groups who received medical treatment showed the usefulness and effectiveness of support.CONCLUSIONS: Application of long term left ventricular support in selected patients with end stage chronic heart failure and preserved right ventricular function is useful offering better survival than medical treatment. Long term left ventricular support by the Jarvik 2000 LVAD appears useful and effective yielding similar or superior results to those achieved with the application of another widely applied 2nd generation continuous flow LVAD