Implantation Via Thoracotomy Approved for Medtronic's HeartWare HVAD System
July 23, 2018—Medtronic announced FDA approval for a less-invasive implantation approach of its HeartWare HVAD system, a left ventricular assist device (LVAD) for patients with advanced heart failure.
The HeartWare HVAD system is now approved in the United States and Europe for implantation via thoracotomy, as well as via median sternotomy. The device is indicated to treat patients with advanced, refractory heart failure as a bridge to cardiac transplantation and as destination therapy in patients for whom subsequent transplantation is not planned.
The company also advised that new surgical implantation tools tailored to assist physicians with the thoracotomy approach for the HVAD system are now available in the United States and countries that recognize CE Mark approval.
According to the company, FDA approval for HVAD implantation via thoracotomy is based on data from the LATERAL prospective clinical trial, in which 144 patients, with end-stage heart failure who were eligible for heart transplant, were enrolled at 26 centers in the United States and Canada.
The primary endpoint of the LATERAL trial demonstrated noninferiority of the HVAD implanted in patients via thoracotomy with 88.1% survival of patients free from disabling stroke or device explant or exchange because of malfunction at 6 months. The trial achieved its primary endpoint (P = .0012) with the success outcome exceeding the prespecified performance goal of 77.5%.
The key secondary endpoint revealed a significant reduction in total length of hospital stay, from an average of 26.1 days down to 18 days (P < .001). Overall survival among patients receiving an HVAD via the thoracotomy procedure was 88.8% at 1 year. Detailed outcomes of the LATERAL trial and its secondary endpoints were presented at The International Society for Heart and Lung Transplantation 2018 Scientific Sessions held April 11–14 in Nice, France.
In the company's press release, LATERAL Principal Investigator Edwin McGee, Jr, MD, commented, "We have demonstrated that a thoracotomy is a safe and effective implantation technique for the HVAD system, which gives physicians added flexibility in treating a broad range of patients. Implanting the HVAD via thoracotomy preserves the chest for a subsequent procedure that patients may need, such as a heart transplant. It also has been shown to result in shorter hospital stays." Dr. McGee is Professor and Director of the Heart Transplant & Ventricular Assist Device Program at Loyola University Medical Center in Maywood, Illinois.