Vanderbilt’s Department of Cardiac Surgery has developed an Advanced Heart Failure Clinical and Translational Research Group that serves as a central research resource for advanced heart failure surgeons and cardiologists.
“We built research support group over the last few years, but it’s really grown over the last year, said Simon Maltais, M.D., Ph.D., assistant professor of Cardiac Surgery. “It’s intended to be a platform for clinical and translational research centered on a group of people whose main interest is advanced heart failure.
“This core group of people has a main objective to make the advanced heart failure research go forward.”
Directed by Maltais and managed by Mary Beth Davis, MSc, CTP, CCRP, the group is staffed by four employees who oversee six clinical trials, an American Heart Association grant and other industry-funded studies, Davis said.
Among those studies is the HVAD® LATERAL Study, a U.S. Investigational Device Exemption (IDE) clinical trial in which the HeartWare® Ventricular Assist System, featuring the HVAD® Pump, is implanted through a less-invasive thoracotomy procedure in patients with end-stage heart failure who are awaiting a heart transplant (bridge-to-transplant therapy). This study compares outcomes of the thoracotomy implant technique to the standard median sternotomy for this patient population.
Vanderbilt was the first study center to enroll a patient in this trial and is among a select group of medical centers that will soon be enrolling patients in the HeartWare destination therapy study.
“HeartMate II and HeartWare have been utilized as bridge-to-transplant only, and we were, thankfully, added to the centers that will be able to implant the HeartWare pump within the trial constraint as destination therapy, designed for patients who are not candidates for transplant,” Maltais said, adding that Vanderbilt’s first destination therapy patient will receive the device next week.
“This is fantastic because those patients who were not candidates for transplantation now have access to the smaller pump. This is unique because we are the only center using HeartWare in Tennessee. The ability to implant this as destination therapy is huge for our patient population.”
Vanderbilt is also the top enrolling center in the country for Thoratec Corporation’s PREVENT study, a prospective, multi-center, non-randomized study that is designed to assess the incidence of pump thrombosis (blood clots) in patients receiving the HeartMate II when recommended practices for clinical management are adopted, and to identify the risk factors associated with pump thrombosis.
The recommended practices are focused on implantation technique, anticoagulation regimen, pump speed and blood pressure management. All patients receiving a HeartMate II implant are considered for this study.
“The goal is to define best practices in patients with HeartMate II implants,” Maltais said.
The trial started six months ago, and Vanderbilt has enrolled 20 patients.
The small Advanced Heart Failure Clinical and Translational Research Group will also have 20 abstract presentations at the upcoming International Society for Heart & Lung Transplantation annual meeting in April in Nice, France.