Despite tremendous progress in treating advanced heart failure, certain patients have remained in limbo: too sick to benefit from medical therapy and specialized pacemakers, yet too well to undergo ventricular assist device (VAD) implantation or transplantation. But a promising new development may show the way out of the dilemma.
The NuPulseCV® Intravascular Ventricular Assist System (iVAS) is a novel, minimally invasive blood pump that uses a two-inch incision in the shoulder to reach the subclavian artery. By avoiding a VAD open procedure, use of iVAS could result in less blood loss, less pain, and a faster post-operative recovery, while providing enough support for intermediate AHF patients. "Also, because it is inserted through the subclavian artery, rather than the traditional access through the groin, patients can move about and even return home with it in place," says Ezequiel J. Molina, MD, MHVI’s surgical director for the Advanced Heart Failure Program, and co-principal investigator for the NuPulse trial.
That premise is now being tested at MedStar Washington Hospital Center, one of 20 eventual sites nationwide selected for a major feasibility study of the device. Should NuPulse prove safe and clinically effective, it could become a proven addition to the AHF armamentarium and an important option for a currently underserved subset of patients.
“NuPulse was created specifically for patients who fall between late Stage C and early Stage D heart failure, what we refer to as INTERMACS 3 through 7,” says cardiologist and co-principal investigator Jonathan Grinstein, MD, who recently joined MHVI from the University of Chicago where the new device underwent first-in-human testing. “It can provide months to years of partial support without the risks and potential complications associated with traditional circulatory assist devices.”
The NuPulse device cannot deliver the same level of support as durable VADs, which are designed to completely take over the heart’s function. The new device can help patients with a certain amount of cardiac reserve, serving as a bridge to recovery, bridge to transplant, bridge to decision, or as a destination therapy of its own. iVAS can be used across the entire spectrum of heart failure, both in heart failure with reduced (HFrEF) and preserved (HFpEF) ejection fraction, and in patients who could possibly recover from their heart failure. The HFpEF patient population currently has limited therapeutic options, yet accounts for nearly 50 percent of patients with heart failure in the U.S. NuPulse has the potential to offer these patients symptomatic improvement.
“Since their inception, VADs have prolonged the lives of end-stage AHF patients awaiting new hearts, and restored life and its quality to many others who may never get a transplant,” says Dr Molina. “But VADs have their own set of complications, including creating adhesions within the heart and chest wall, which can make subsequent heart surgery or transplantation more difficult. That’s not a problem with the iVAS.
MedStar Washington Hospital Center is currently enrolling candidates in the study. To see if your patient might qualify, please contact 202-877-4698.