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LATERAL: LVAD implant reduces risk for stroke
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Medtronic announced that clinical trial data for its left ventricular assist device showed that 95% of recipients were free from disabling stroke after 2 years of follow-up.
The findings of the LATERAL trial, which evaluated the use of the system (HeartWare HVAD, Medtronic) in patients who had the device implanted via thoracotomy, were presented at the American Society for Artificial Internal Organs conference in San Francisco, the company stated in a press release.
“Remembering my earliest experiences with the very first HVAD system implant in [a] patient more than 15 years ago, I’ve seen both the significant benefits and also the risks for patients who receive a ventricular assist device. These new data are impressive,” Georg Wieselthaler, MD, the director of the heart transplant and mechanical circulatory support programs at the University of California, San Francisco, and a LATERAL trial investigator, said in the release. “Many of us have dedicated our lives’ work to improving this therapy, including minimizing adverse events.”
Research from the trial found that adverse events were more likely to occur during the first 30 days after implant, with a decline in bleeding (1.53 vs. 0.51 events per patient-year; P < .001) and in arrhythmias (3.22 vs. 0.26 events per patient-year; P < .001), according to the release. There was also a decline in strokes at 30 to 180 days (0.51 vs. 0.12 events per patient-year; P = .01), according to the release.
Overall, adverse event rates were meaningfully reduced 1 to 6 months after implant, according to the release.
Late risk for stroke was “very low,” with total stroke occurring at only 0.05 events per patient-year in years 1 and 2 after implant, the release stated. Previously published data from the LATERAL trial showed survival at 87% after 2 years.
The heart system is available in 56 countries and has the “broadest base of clinical evidence of any centrifugal-flow LVAD,” with more than 2,000 clinical trial patients and 18,000 worldwide implants, according to the release.
“These data give us more comprehensive information showing low adverse event and stroke rates for end-stage heart failure patients who receive the HVAD system,” Rob Kowal, MD, PhD, chief medical officer and vice president of medical affairs in the cardiac rhythm and heart failure division at Medtronic, said in the release.
Reference:
Weiselthaler G, et al. Cardiac 1: The Future of MCS. Presented at: American Society for Artificial Internal Organs Annual Conference; June 26-29, 2019; San Francisco.
Disclosures: Kowal is an employee of Medtronic. Wieselthaler reports he serves as an adviser to Medtronic.