VCU Health Pauley Heart Center cardiothoracic surgeons Daniel Tang, M.D., and Mohammed Quader, M.D., are taking part in several clinical trials involving new devices for patients with advanced heart failure.
“The field of device therapy for advanced heart failure has certainly exploded,” said Tang. “Yet despite the marked improvement in outcomes with newer generation devices, patients still face significant potential for adverse events.” For that reason, “VCU remains actively engaged in being at the forefront of advanced therapies for end-stage heart failure.”
Here are some updates from some recent trials:
Momentum (Heartmate III) – Chair of Surgery Vigneshwar Kasirajan, M.D., is the primary investigator (PI) for this Phase III trial. Patients are implanted with the Heartmate III left-ventricular assist device (LVAD), which offers the use of a magnetically levitated rotor with wider flow pathways than previous models, along with other innovations. The device is being evaluated for its safety and effectiveness, and patients are compared to a control group using the Heartmate II.
The trial began in Jan. 2015, and short-term results from the trial’s first 1,000 enrolled patients were reported at the Nov. 2016 AHA Scientific Sessions.
“Overall, outcomes were relatively similar, but the Heartmate III group did demonstrate superiority compared to the Heartmate II in freedom from re-operation for pump thrombosis [the creation of blood clots, which increases the risk of strokes],” said Tang. “While we wait for further and longer-term results, the trial is currently enrolling another 1,000 patients.”
“VCU remains actively engaged in being at the forefront of advanced therapies for end-stage heart failure,” said Tang.
Heartware HVAD Lateral – This non-randomized study, which was conducted to explore the feasibility of using a minimally invasive approach to implant this continuous flow, centrifugal LVAD. The trial completed its enrollment of 145 patients in 2016, with preliminary six-month results reported at the recent International Society for Heart and Lung Transplantation meeting in April.
“The data is undergoing review and only very early results have been reported. It appears promising as there was 92 percent survival rate at six months,” said Tang. “Our experience and pretrial data suggests potential benefits of reduced blood loss and possible less right ventricular failure.”
Syncardia DT trial – Tang is the PI for this Phase III trial, which explores the Syncardia DT total artificial heart as destination therapy—that is, implanted permanently instead of as a bridge-to-transplant.
“The trial is ongoing, with very limited enrollment. We were the first center to enroll a patient—who was, for a time, the only patient,” said Tang. “It is a challenging trial due to a very narrow risk/benefit window. Nonetheless, it is an important trial as the total artificial heart may be the only device option for certain patients who are not candidates for transplantation.”
Syncardia 50cc trial – Tang is the PI for this Phase III trial, which is open for enrollment. “The current 70cc device offered by Syncardia is sized for large men. The smaller pump opens the total artificial heart to smaller-sized patients—namely, women and children,” he said.