LVAD yields high 6-month survival rate in first human trial

In the first human experience with a novel left ventricular assist system, patients with advanced HF exhibited a 92% survival rate at 6 months with no hemolysis or pump thrombosis or exchange, according to results presented at the Heart Failure Society of America Annual Scientific Meeting.

The prospective, multicenter, nonrandomized CE Mark trial was the first to assess the performance and safety of the HeartMate 3 (Thoratec Corp.) LV assist device in humans. The study included 50 patients (mean age, 59 years; 90% men) who received the device as either a bridge to transplant (54% of patients) or destination therapy (46%) at 10 centers in six countries from June to November 2014. All patients had LV ejection fraction of 25% or lower and had either been referred for transplant, had received and failed to respond to optimal medical management for 45 of the prior 60 days, or were dependent on or unable to be weaned from inotropes.

The primary endpoint was survival at 6 months compared with a prespecified performance goal established using data from patients enrolled in the INTERMACS registry who were treated with the HeartMate II device. Secondary endpoints included survival at 6 months compared with predicted survival according to the Seattle Heart Failure Model (SHFM), adverse events, quality of life and functional status as indicated by 6-minute walk test results and improvement to NYHA class.

At 6 months, 92% of patients who received HeartMate 3 survived, compared with the performance goal of 88%, Ivan Netuka, MD, PhD, of the Institute for Clinical and Experimental Medicine, Prague, said during a presentation. Compared with the SHFM predicted survival rate of 78%, Netuka said treatment with HeartMate 3 reduced risk for mortality at 6 months by 66% (HR = 0.34; P = .0093).

During the 6-month period, 8% of patients died, 4% underwent transplant and the remaining 88% were ongoing. Most adverse events occurred within the first 30 days after implantation. Gastrointestinal bleeding occurred in 8% of patients, which Netuka said was lower than rates observed in published literature. Four patients experienced ischemic stroke and two experienced hemorrhagic stroke. No patients experienced pump malfunction, thrombosis or hemolysis.

Most patients (83%) were NYHA class I or II at 6 months, representing a significant improvement from baseline, Netuka said (P < .0001). Results from 6-minute walk tests also improved by a median of 231 m (P < .0001). Quality of life, as indicated by EuroQol score, improved from baseline at 3 months, and this improvement persisted at 6 months (P < .0001 vs. baseline for both).

“This was a positive first experience with HeartMate 3,” Netuka concluded, adding that additional data was forthcoming, including 2-year follow-up data from the CE Mark trial, along with the randomized MOMENTUM 3 trial of the device, which is currently in the enrollment phase. “Undoubtedly, this is just the end of a very exciting beginning.” – by Adam Taliercio

Reference:

Netuka I, et al. Late-Breaking Clinical Trials. Presented at: Heart Failure Society of America Annual Scientific Meeting; Sept. 26-29, 2015; National Harbor, Md.

Disclosure: Netuka reports serving as a surgical proctor and consultant for Thoratec Corporation, which sponsored the study.