On November 18, the heart failure and transplantation team at Emory University Hospital made history, performing the first-ever surgical implantation in the United States of a brand-new type of ventricular assist device (VAD), which provides crucial care to patients with failing hearts.
An expert team led by veteran cardiothoracic surgeon Mani Daneshmand, MD, successfully implanted a magnetically levitated pump, a VAD that has been redesigned for patient ease and long-term health. The BrioVAD, made by BrioHealth Solutions Inc., was authorized by the FDA in May for clinical trials. Emory became the first site enrolled in the trial to perform the procedure.
As part of the INNOVATE clinical trial, Emory will participate in gathering data on patient experience with the device, joined by other leading medical institutions across the country, including Cleveland Clinic Foundation, Duke University, and University of Chicago.
The entry criteria for joining the study were rigorous. Emory qualified because of its high quality and extensive VAD experience. Emory has long led Metro Atlanta and the region in number and success rate of VAD implantations, surpassing 500 implantations two years ago.
“We’re honored to be the first implanting site in this study,” Daneshmand says. “The BrioVAD is a promising heart assist pump, designed from the ground up with focus on patient safety and quality of life. With this study, we continue our long history of innovation in pursuit of our mission to bring compassionate, quality care to every patient who arrives at our doors seeking care."
First used in the 1960s, VADs have been an effective treatment for patients with advanced heart failure, often providing an alternative for patients who don’t qualify for a transplant – which can mean the difference between life and death.
Over the decades, VAD technology has gone through significant evolution – and this represents the next step in that continued progression. The BrioVAD system is composed of a “hemocompatible blood pump,” meaning that it interacts with the blood in a way that has fewer side effects. The new VAD also includes a fully magnetically levitated rotor and two small, lightweight, patient-worn components.
The lifesaving device works by providing mechanical circulatory support and helping to pump blood from the lower chambers of the heart to the rest of the body. Because the device is almost always placed on the left side of the heart, the device is frequently referred to as an LVAD.
“The BrioVAD shows great promise to improve on the current, excellent LVAD technology we are using every day,” says Daneshmand, who is the Andrew J. McKelvey Professor at Emory School of Medicine and Director of Thoracic Transplant and MCS Surgery.
Daneshmand cites some of the advantages of the new device, which include:
- A full redesign of the impeller technology (or the machinery that does the pumping), which facilitates better blood flow and may more closely mimic the natural rhythmic patterns of a human pulse. That seemingly subtle difference can have major benefits for patients.
- Current VADs have safely supported patients for over 10 years either as their permanent therapy or while they await a heart transplant. Daneshmand says he and his team hope that patients may be able to live comfortably with the BrioVAD device for decades.
- The pump itself is smaller, making it less cumbersome to implant and potentially less labor-intensive to remove if a VAD recipient winds up needing a heart transplant down the line.
- The blood flow paths of the pump are larger, which means that that it may be more compatible with the body’s biological systems and cause less blood trauma.
- The pump also has a much thinner, more flexible driveline, which means it has far lower risk of possible infection, because it has less interaction with normal range of motion (and causes less trauma after implantation).
- The support structures have also been redesigned for a better patient experience. Whereas the VAD that is used commercially now includes two large, heavy batteries that must be worn at all times by the patient (unless the patient is in a spot where they can be plugged into a power source), the BrioVAD has a smaller controller with the backup battery included – meaning that the patient only needs to be hooked up to one battery , which is lighter and more energy dense. That means patients may be far more comfortable in their day-to-day.
The hope is that the new VAD may be used both as a destination therapy, meaning that the VAD is used instead of transplant, or as bridge therapy to transplant. The INNOVATE trial will assess the system performance in both the short term, with a six-month endpoint, and in the long term over the course of the next 24 months.