University of Louisville heart transplant surgeon Mark Slaughter, MD, has implanted two patients with an investigational device, the intravascular ventricular assist system (iVAS), at Jewish Hospital to improve heart function.
The iVAS is a minimally invasive alternative to ventricular assist devices for use in patients with severe heart failure, allowing more mobility and implant without open-heart surgery. The iVAS supports heart function and can be used temporarily while patients await a heart transplant or as a more permanent treatment. UofL is the only site in Kentucky participating in the iVAS trial.
The iVAS is a counterpulsation heart device, assisting the heart by pumping between beats while the heart is resting to increase the flow of blood and oxygen to the heart. Manufactured by NuPulseCV Inc., the device consists of a balloon-type pump placed in the descending aorta. This pump is inflated and deflated to help move blood through the body. The intra-aortic pump is connected through the skin to an external drive unit. The new technology is an improvement over other heart assist devices such as the left ventricular assist device (LVAD) most significantly in that the iVAS is implanted with a minimally invasive procedure, not requiring open heart surgery.
“The iVAS is put in through a peripheral artery so it does not require opening the chest or placing the patient on a heart-lung machine,” said Slaughter, chair of the Department of Cardiovascular and Thoracic Surgery in the UofL School of Medicine and surgical director of heart transplant and mechanical assist devices for UofL and Jewish Hospital. “Through this clinical trial, we may find additional advantages such as the opportunity for patients to disconnect from the device intermittently. With the VAD, you are always tethered to the device. With the iVAS, you may be able to be untethered or turn it off for short periods,” Slaughter said.
Another benefit, Slaughter said, is patients are not required to be on long-term blood thinners, which can have serious side effects.
Robert Hughes, one of the patients who received the iVAS implanted by Slaughter in Louisville, had a heart attack in May and subsequently learned he had heart failure.
“I finished chemo for leukemia in January. I had gone from 200 pounds to 145 pounds and I was pretty weak,” Hughes said. “Then I had the heart attack on May 17. Afterward I was getting dizzy just standing. I felt like I would faint. It was very unnerving. I didn’t want to get out and do a nosedive at Pic Pac,” Hughes said.
Hughes’s diagnosis was advanced heart failure, but he did not qualify for either a heart transplant or open-heart surgery, so when he was presented with the iVAS as a long-term option, he was ready to participate in the trial. His iVAS was implanted on Aug. 13. Within a few weeks, he was able to go home.
“Since the surgery, I feel stronger and haven’t had dizzy spells. I am gaining my weight back,” Hughes said. “I am very pleased with the outcome. As far as I’m concerned, everything is a plus.”
Hughes said he has been able to get out for trips to the drug store or grocery store without fear of passing out. The external drive unit for iVAS weighs only 8 pounds, permitting patients to be discharged from the hospital to await transplant or continue their lives at home and free to go out in the community.
The goal of the clinical trial is to determine whether iVAS is as effective as the LVAD. Including the two patients at Jewish Hospital, 70 patients have been implanted with the iVAS device in 12 centers across the United States.
Learn more about clinical trials at UofL here.
