Medtronic’s HVAD System, a left ventricular assist device, can now be implanted via a thoracotomy, a less invasive procedure than a median sternotomy. Moreover, a thoracotomy means that future procedures that may require access through the chest can still be performed in what are already risky patients.
The HVAD System is indicated for those with advanced, refractory heart failure, both as a bridge to a heart transplant and as a final therapy if a transplant is not an option.
Some details about what led to this news:
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 U.S. and Canada. The primary endpoint of the trial demonstrated non-inferiority of the HVAD implanted in patients via thoracotomy, where survival at six months free from disabling stroke or device explant or exchange due to malfunction was achieved in 88.1 percent of patients. Since the success outcome exceeded the pre-specified performance goal of 77.5 percent, the trial achieved its primary endpoint (p=0.0012). 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<0.001). Overall survival among patients receiving an HVAD via the thoracotomy procedure was 88.8 percent at one year.
Flashbacks: Early Success in HVAD LATERAL Trial: Interview with Medtronic’s Dr. David Steinhaus, M.D., Vice President and General Manager, Heart Failure…; Interview with David Steinhaus, VP of Cardiac Rhythm Disease Management at Medtronic…; Medical Heart Pumps from HeartWare: HVAD, MVAD and PedVAD…;
Info page: HeartWare HVAD System…