Heart Transplantation

March 19, 2018

Abbott announced new late-breaking clinical trial data from the MOMENTUM 3 clinical study. The MOMENTUM 3 Investigation Device Exemption (IDE) study is a prospective, multi-center, randomized, unblinded study evaluating the safety and effectiveness of the HeartMate 3 LVAD. HeartMate 3 LVAD is a small, implantable mechanical circulatory support (MCS) device for advanced heart failure patients who are awaiting transplantation or are not candidates for heart transplantation. Patients receiving HeartMate 3 LVAD had significant improvements compared to the HeartMate II LVAD in functional capacity and quality of life scores at two years compared to baseline. Patients with the HeartMate 3 LVAD had a survival rate of 82.8 percent at two years compared to 76.2 percent for those with the HeartMate II LVAD. Stroke rate was significantly lower (10 percent) for the HeartMate 3 LVAD compared to the HeartMate II LVAD (19 percent). Rates of all other adverse events were similar between the HeartMate 3 LVAD and historical rates seen in the HeartMate II LVAD.

April 15, 2002

Study results suggest that Novartis' Certican (everolimus) significantly reduces the incidence of acute rejection episodes and the potential for graft vasculopathy in heart transplant recipients, compared to add-on therapy with azathioprine. The 12-month, double-blind, international trial included 634 heart transplant subjects who were receiving the standard regimen of Neoral (cyclosporine) and steroids. Subjects were randomized to also receive Certican 1.5mg/day, Certican 3.0mg/day or azathioprine 1-3mg/kg/day. The acute rejection rate was 30.6% in subjects receiving Certican 1.5mg/day and 21.3% in those receiving Certican 3.0mg/day, compared to 45.8% with azathioprine 1-3mg/kg/day. Additionally, allograft vasculopathy was lower in the Certican 1.5mg and 3.0mg groups (35.7% and 30.4%), compared to subjects receiving azathioprine (52.8%).