Preliminary results from the Medtronic -sponsored HVAD LATERAL study have demonstrated overall positive results. The data were presented as a late breaking clinical trial during the 2017 International Society for Heart and Lung Transplantation scientific meeting (ISHLT; 5-8 April, San Diego, USA). Patients with end-stage heart failure, who have not responded to standard medical management and are eligible for heart transplantation, received the HVAD system—a mechanical pump that delivers blood to the body—through a less-invasive thoracotomy procedure.
The HVAD system is not approved in the USA for implantation via the thoracotomy procedure.
Results showed that, at six months, 87.6% of patients remained alive on the original device and free from disabling stroke, or received a heart transplant, or were explanted due to recovery. Since the percentage of patients exceeded the pre-specified performance goal of 77.5%, the trial successfully met its primary endpoint (p-value = 0.002). Simon Maltais, chair of clinical practice, Department of Cardiovascular Surgery, Mayo Clinic, Rochester, USA, presented the data.
LATERAL is the largest, prospective clinical trial of a full-support ventricular assist device (VAD) to evaluate the thoracotomy implant technique (study group).
The study, involving 30 centres in the USA and Canada, enrolled 145 patients with end-stage heart failure who have not responded to standard medical management and who are eligible for heart transplantation. Patients were followed for six months post-implant. Adverse events (AEs) observed in the study at 30 days included cardiac arrhythmia (22.1%); right heart failure (22.1%); bleeding requiring reoperation (3.4%); and stroke (4.1%). Overall survival among patients receiving an HVAD via the thoracotomy procedure was 91.8% at six months. US Food and Drug Administration submission of the data is planned for later this year.
“The LATERAL trial demonstrates overall positive outcomes for patients who received the HVAD System via a thoracotomy procedure,” says Edwin McGee, professor and director, Heart Transplant & Ventricular Assist Device Program, Loyola University Medical Center, Maywood, USA. “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.”