The results of the MOMENTUM 3 US IDE clinical study, which were presented at a late-breaking clinical trial at the 2016 American Heart Association (AHA) scientific sessions (12–16 November, New Orleans, USA) indicate that St Jude Medical’s HeartMate 3 left ventricular assist device (LVAD) is associated with significantly improved clinical outcomes than is the HeartMate II device. The devices were evaluated in patients with advanced heart failure.
The MOMENTUM 3 IDE study is a prospective, multicentre, randomised, unblinded, study evaluating the safety and effectiveness of the HeartMate 3 LVAD for the treatment of advanced, refractory, left ventricular heart failure. More than 1,000 patients with New York Heart Association (NYHA) Class IIIB or IV heart failure are participating in the study. Patients are being followed for a short-term endpoint of six months, and a long-term endpoint of two years. The data presented at the AHA show the results at the six-month follow-up in the first 294 patients enrolled.
The primary endpoint was six months’ survival with freedom from disabling stroke and reoperation to repair or replace the device. The study met its primary endpoint (non-inferiority P<0.0001; superiority P=0.037), and demonstrated that patients receiving the HeartMate 3 LVAD had an 86.2% survival rate with freedom from disabling stroke and reoperation to repair or replace the device. Also, there were no pump thrombosis events reported in patients who were implanted with HeartMate 3 LVAD at six months—confirming the results observed with the HeartMate 3 LVAD in the CE Mark trial. Rates of all other adverse events were similar between the HeartMate 3 LVAD and historical rates seen in the HeartMate II LVAD, which a press release reports is the most widely used and extensively studied LVAD commercially available. This study included all-comers patients.
Presenter of the study and investigator, Mandeep R Mehra (medical director of Brigham and Women’s Hospital Heart and Vascular Center, Boston, USA) comments: “The Heartmate 3 LVAD improved clinical outcomes in the MOMENTUM 3 study by avoiding the need for surgical reoperation to replace or remove the pump due to pump thrombosis. More importantly, these clinical gains occurred without an increase in other adverse events, providing important therapeutic progress for our advanced heart failure patients.”
According to the press release, HeartMate 3 is a small, implantable mechanical circulatory support device for advanced heart failure patients who are awaiting transplantation or are not candidates for heart transplantation. It is the first commercially approved (CE marked) LVAD with Full MagLev technology, designed to minimise complications and restore blood flow. The HeartMate 3 system uses Full MagLev technology, which allows the device’s rotor to be “suspended” by magnetic forces. This design aims to reduce trauma to blood passing through the pump and improve outcomes for patients.
The HeartMate 3 LVAD is limited by federal law to investigational use in the United States.