July 8, 2019—Medtronic announced the presentation of 2-year outcomes from the LATERAL clinical trial evaluating the use of its HeartWare HVAD system, a left ventricular assist device (LVAD) for patients with advanced heart failure. The data were presented at the American Society for Artificial Internal Organs 65th annual conference held June 26–29, 2019, in San Francisco, California.

LATERAL evaluated patients who received the HeartWare system via a thoracotomy implantation approach. The data showed that after 2 years of follow-up, 95% of HVAD patients implanted via thoracotomy were free from disabling stroke (modified Rankin scale score > 3).

A review of adverse events that occurred in the LATERAL trial revealed that adverse events were more likely during the first 30 days after implantation, with a significant decline in bleeding events (1.53 vs 0.51 events per patient-year [EPPY]; P < .001), arrhythmias (3.22 vs 0.26 EPPY; P < .001), and strokes (0.51 vs 0.12 EPPY; P = .01) in the later time periods (> 30 days to 180 days) that patients are on LVAD support.

Overall adverse event rates were meaningfully reduced 1 to 6 months postimplantation. The late risk of stroke was very low, with total strokes occurring at only 0.05 EPPY in years 1 to 2 postimplantation, reported Medtronic.

Previously, data from the LATERAL trial showing 87% survival at 2 years were published by Edwin McGee Jr, MD, et al in Journal of Heart and Lung Transplantation (2019;38:344–351).

Georg Wieselthaler, MD, an investigator in the LATERAL trial, commented in the company's announcement, “Remembering my earliest experiences with the very first HVAD system implant in 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.”

Dr. Wieselthaler continued, “Many of us have dedicated our lives’ work to improving this therapy, including minimizing adverse events. The HVAD pump’s small size lends itself to the less invasive surgical approach, and to see 95% freedom from disabling stroke at 2 years with the HVAD system implanted via thoracotomy reinforces that we are making dramatic strides in this therapy.” Dr. Wieselthaler is Director of the Heart Transplant and Mechanical Circulatory Support programs at UC San Francisco in San Francisco, California.

Medtronic advised that the HVAD system is approved for implantation via thoracotomy or median sternotomy in the United States and in countries that recognize CE Mark. In addition to ongoing follow-up of patients from the LATERAL trial, Medtronic plans to launch a global registry to collect additional clinical evidence to further characterize survival, adverse events, and economic benefits of the HVAD system when implanted via a lateral thoracotomy in bridge-to-transplant or destination therapy patient populations.