Thoratec's HeartMate 3 CE-Mark Trial Meets Primary Endpoint

September 29, 2015—Thoratec Corporation announced that results from the HeartMate 3 CE Mark trial were presented at HFSA 2015, the 19th annual scientific meeting of the Heart Failure Society of America in Washington, DC. Thoratec expects to receive CE Mark approval for HeartMate 3 during the fourth quarter of 2015.

According to the company, the HeartMate 3 left ventricular assist device (LVAD) met the primary endpoint, which was a comparison of 6-month survival to a performance goal derived from INTERMACS, the interagency registry for mechanically assisted circulatory support. The HeartMate 3’s 6-month survival of 92% surpassed the HeartMate 2 INTERMACS-derived performance goal of 88%. 

Additionally, overall functional status improved significantly with HeartMate 3 support as measured by changes in the 6-minute walk distance and New York Heart Association (NYHA) classification. At 6 months, patients experienced median improvement of 231 meters in the 6-minute walk test, and 83% of patients improved to NYHA class 1 or 2 status, representing statistically significant improvements compared with baseline status.

Ivan Netuka, MD, presented the HeartMate 3 CE Mark study data at HFSA. Dr. Netuka is Deputy Head at IKEM, the Institute for Clinical and Experimental Medicine in Prague, Czech Republic. 

In the company’s press release, Dr. Netuka commented, “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.”

Thoratec reported that overall 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, hemolysis, or device malfunction during the 6-month follow-up period. Gastrointestinal bleeding, another common adverse event with LVAD therapy, occurred in only 8% of patients with HeartMate 3 and was notably below event rates in published data from previous LVAD clinical trials. 

Stroke occurred in six patients (12%), with four ischemic and two hemorrhagic events. Three of the six events were determined to be procedural related and may not represent risk related to the device. Two of the three nonprocedural-related stroke events were Modified Rankin Scale (MRS) 1 in patients that remain on HeartMate 3 support. Despite inclusion of these potentially nondevice-related and MRS 1 events, reported stroke rates in the CE Mark trial were still consistent with expected rates based on previous LVAD trial experience, stated the company.

The HeartMate 3 CE Mark trial is a prospective, multicenter, nonrandomized study designed to examine the first human experience with HeartMate 3. Between June and November 2014, the study enrolled 50 patients at 10 hospitals in six countries outside of the United Stated. Enrollment included both bridge-to-transplant and destination therapy patients in NYHA class 3b or 4 heart failure. The primary endpoint comparing 6-month survival to a performance goal derived from the INTERMACS registry has been met. Patient follow-up will continue during the first 2 years of ongoing support, while enrollment is ongoing in the HeartMate 3 United States investigational device exemption trial, advised Thoratec.