Primary endpoint met in HeartMate 3 CE mark trial


Thoratec has announced that the HeartMate 3 trial, which evaluated the HeartMate 3 left ventricular assist device (LVAD), has met its primary endpoint—a comparison of six month survival to a performance goal derived from the INTERMACS registry. The trial was presented at the 19th annual scientific meeting of the Heart Failure Society of America (HFSA; 26–29 September, Washington DC, USA).

A press release reports that survival with HeartMate 3 at six months was 92% compared with the HeartMate II INTERMACS-derived performance goal of 88%, achieving the primary endpoint. Overall functional status improved significantly with HeartMate 3 support, as measured by changes in the six-minute walk distance and New York Heart Association (NYHA) classification: at six months, patients experienced median improvement of 231m in the six-minute walk test and 83% of patients improved to NYHA Class I or II status, representing statistically significant improvements compared with baseline status.

According to the press release, adverse event rates with HeartMate 3 were either lower than or consistent with expectations for severely ill complex patients requiring LVAD support. There were no instances of pump thrombosis, haemolysis, or device malfunction during the six month follow-up period.  Gastrointestinal bleeding, another common adverse event with LVAD therapy, occurred in only 8% of patients with HeartMate 3 and was below event rates in previously published data from prior LVAD clinical trials.  Stroke occurred in 12% of patients, including 8% with ischaemic and 4% with haemorrhagic events. Half of these events (three of six), were determined to be procedural related and may not represent risk related to the device. Two of the three non-procedural related stroke events were Modified Rankin Scale (MRS) 1 in patients that remain on HeartMate 3 support.  Despite inclusion of these potentially non-device related and MRS 1 events, reported stroke rates in the CE Mark trial were still consistent with expected rates based on prior LVAD trial experience.

Ivan Netuka, presenter of the HeartMate 3 CE Mark study data at HFSA and deputy head at the Institute for Clinical and Experimental Medicine (IKEM) in Prague, Czech Republic, says: “The CE mark trial data represents a very positive initial experience with HeartMate 3, including high survival rates, material improvement in functional status, and very low adverse event rates highlighted by zero pump thrombosis events. HeartMate 3 is a very promising LVAD technology based on the advancement in clinical outcomes demonstrated in this trial.”

The press release notes that HeartMate 3 is a centrifugal-flow chronic left ventricular assist system using Full MagLev, a fully magnetically levitated technology foundation designed to lower adverse event rates while also enhancing the ease of surgical placement through a compact size. It adds that HeartMate 3 CE Mark trial is a prospective, multicentre, non-randomised study designed to examine the first human experience with HeartMate 3. The study enrolled 50 patients at ten hospitals in six countries outside of the USA between June and November 2014.  Enrolment included both bridge-to-transplant and destination therapy patients in NYHA Class IIIb or IV heart failure, and the primary endpoint comparing six month survival to a performance goal derived from the INTERMACS registry has been met.  Patient follow-up will continue during the first two years of ongoing support, while enrollment in the HeartMate 3 US IDE trial remains ongoing. Thoratec expects to receive CE Mark approval for HeartMate 3 during the fourth quarter of 2015.