Medtronic (NYSE:MDT) this week presented results from the HVAD Lateral thoractomy study of its HVAD heart pump system in patients with end-stage heart failure, touting high survival rates and freedom from stroke.
The study aimed to explore the use of the HVAD system delivered through a less-invasive thoracotomy procedure in patients with end-stage heart failure who were eligible for heart transplantation, the Fridley, Minn.-based company said
Trial results were presented at the 2017 International Society for Heart and Lung Transplantation Scientific Meeting in San Diego.
Data from the study indicated that at 6-months, patients had an 87.6% rate of survival on the original device and free from disabling stroke, or received a heart transplant or were explanted due to recovery. The trail met its primary endpoint as the result was over the prespecified primary endpoint goal of 77.5%, Medtronic said.
The 145-patient, 30-center Lateral trial reported a 22.1% rate of cardiac arrhythmias, 22.1% rate of right heart failure, 3.4% rate of bleeding requiring reoperation and 4.1% rate of stroke at 30 days. Overall survival for patients receiving an HVAD via thoractomy was 91.8% at 6 months.
“The Lateral trial demonstrates overall positive outcomes for patients who received the HVAD System via a thoracotomy procedure. While we only have an early snapshot of adverse event rates at 30 days, we are encouraged by the preliminary data. We look forward to reviewing longer-term patient data, as well as getting a more complete picture of the average length of hospital stay, another meaningful measure for VAD patients,” Dr. Edwin McGee Jr. of Maywood, Ill.’s Loyola University Medical Center said in a prepared release.
The company said hopes to submit data to the FDA later this year.
“The Lateral trial represents positive, contemporary results with the HVAD System, with overall survival rates of nearly 92% at 6 months. This innovative technique was pioneered by clinicians whose contributions have helped to significantly advance the field of mechanical circulatory support. The data presented today support this less-invasive surgical approach,” Medtronic heart failure biz GM Dr. David Steinhaus said in a press release.
The company also presented on a separate study, the Endurance trial, of the HVAD system as destination, or long-term, therapy. Data indicated that patients classified as INTERMACS level 1 or 2 did not report worse outcomes than those considered less sick when treated with an HVAD system.
Data from the Endurance trial was published in The New England Journal of Medicine.