The investigational device, currently intended as a bridge to heart transplant, is part of an Early Feasibility Study (EFS) sponsored by CARMAT, a French medical device company, in partnership with UofL, UofL Health – Jewish Hospital and the UofL Health – Trager Transplant Center.

Led by cardiothoracic surgeons Mark Slaughter and Siddharth Pahwa, both of UofL Health – UofL Physicians and the UofL School of Medicine, the team performed the implant of the device on Sept. 14, 2021 at UofL Health – Jewish Hospital. The same team completed the nation’s second implantation in a male patient last month, also at Jewish Hospital.

“For the other half of the world’s population, completion of this procedure by the Jewish Hospital team brings new hope for extended life,” said Slaughter, UofL Health surgical director of heart transplant and professor and chair of the Department of Cardiovascular and Thoracic Surgery in the UofL School of Medicine. “Size limitations can make it harder to implant artificial hearts in women, but the Aeson artificial heart is compact enough to fit inside the smaller chest cavities more frequently found in women, which gives hope to a wider variety of men and women waiting for a heart transplant and increases the chances for success.”

More than 3,500 individuals are awaiting a heart transplant in the U.S. and 900 of them are women. There are few treatment options for patients with biventricular heart disease, meaning both the left and right sides of the heart are not pumping blood adequately. The Aeson device is designed to solve the limitations of current left-ventricular assist devices, which pump blood in just one chamber, by pumping blood in both heart chambers.

Aeson also contains pressure sensors that estimate the patient’s blood pressure and automatically adapts cardiac output according to the sensor information. It is fully implanted as a heart replacement and powered by a portable external power supply.

During this procedure, the Aeson total artificial heart was implanted into a 57-year-old Kentucky woman with severe biventricular heart failure during an eight-hour surgery. The recipient, whose identity is being withheld upon request, was referred to the Advanced Heart Failure Therapies Program at Jewish Hospital earlier this year with end-stage heart failure and had undergone cardiac surgery years before. The patient is recovering well in the cardiovascular intensive care unit. Jewish Hospital is just one of four programs in the nation approved to perform this clinical trial procedure.

“The varying pumping ability of the Aeson device increases its viability among more patients,” said Pahwa, UofL Physicians cardiothoracic surgeon and assistant professor in the UofL Department of Cardiovascular and Thoracic Surgery. “While other devices are set at a fixed rate or create a continuous flow, CARMAT has developed the Aeson to automatically adjust the flow, creating an improved performance to meet the body’s changing blood flow needs.”

Currently, the Aeson artificial heart is tested as a bridge to transplant for patients with end-stage biventricular heart failure, allowing more time for the patient to receive a permanent heart organ transplant. The device already has been approved for such use in Europe, where approximately 20 devices have been implanted. It currently is being tested in the U.S. as part of a feasibility study approved by the Food and Drug Administration. The first Aeson artificial heart in North America was implanted in a male patient in July at Duke University Medical Center. The second implantation, also in a male patient, was performed at Jewish Hospital in August. This third North American implantation is the first to involve a female patient.

“Even as we have fought this deadly pandemic, our researchers and health care providers have also been on the front lines of improving care and quality of life for not only Kentuckians, but for people around the world,” said Kentucky Gov. Andy Beshear. “I am proud that UofL, Jewish Hospital and their doctors are leading the world in implanting this promising and innovative device that could offer hope and time to thousands of people, including our wives, mothers and other loved ones, in coming years.”

Stéphane Piat, chief executive officer of CARMAT, said, “This third implant in the U.S. was a landmark event not only because it allowed us to finalize the enrollment of the first cohort of patients of the EFS, but very importantly because it is the first time ever that our device has helped a woman suffering from heart failure. This achievement confirms that the size limitations for adults are minimal, which makes us very confident in Aeson’s potential to become a therapy of choice for a broad patient population.”

Preclinical research for CARMAT’s artificial heart began at UofL more than five years ago. Researchers at UofL’s Cardiovascular Innovation Institute tested Aeson’s autoregulation capability, which allows the device to adapt its flows according to the patient’s needs by detecting changes of pressure in the device. UofL researchers have conducted preclinical testing of artificial heart components and mechanical assist devices at CII for many years, testing some portion of nearly every mechanical assist device that is commercially available today.

Jewish Hospital and the University of Louisville share a storied history in advancing heart care. Highlights include:

• Aug. 24, 1984: Kentucky’s first heart transplant performed at Jewish Hospital by UofL physicians
• July 2, 2001: The world’s first AbioCor artificial heart was implanted at Jewish Hospital by UofL physicians, led by cardiothoracic surgeon Laman Gray
• Dec. 21, 2011: Kentucky’s first transcatheter aortic-valve replacement performed at Jewish Hospital by UofL physicians
• Jan. 18, 2015: Kentucky’s first HeartMate 3 left ventricular assist device implanted at Jewish Hospital by UofL physicians
• Feb. 21, 2018: UofL Health – Trager Transplant Center’s 500^th heart transplant performed at Jewish Hospital
• June 14, 2019: The first EvaHeart2 LVAD implanted as bridge to transplant at UofL Health – Trager Transplant Center
• April 22, 2021: UofL Health – Trager Transplant Center’s 1000^th TAVR performed at Jewish Hospital

“This world-first artificial heart implant into a female patient is another demonstration of UofL Health’s commitment to provide both the world-class care of today and develop the world-class standards of tomorrow,” said John Walsh, chief administrative officer of Jewish Hospital. “We celebrate this first as a milestone and recognize the hard work of Drs. Slaughter and Pahwa and the entire team. The true impact of their work will be measured in the dozens, hundreds and thousands of lives improved in the years to come.”

The patient who received the nation’s second Aeson implant, on Aug. 20, 2021, continues to improve at Jewish Hospital. An update is expected in the coming weeks.

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 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 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 .

Birks presented preliminary results of the study at the American Heart Association’s Scientific Sessions this weekend in New Orleans, showing more than 40 percent of advanced heart failure patients treated with a combination of an artificial heart assist device, called a left ventricular assist device (LVAD), and intensive drug therapy have recovered their heart function enough to allow removal of the LVAD device.

The multicenter trial called RESTAGE, includes 40 patients at six different centers (including , a part of KentuckyOne Health) with very advanced or end stage heart failure implanted with an LVAD (HeartMate II) pump, 36 of whom were considered evaluable, and prescribed an aggressive combination of drugs (Lisinopril 40 mg, spironolactone 25 mg, digoxin 125 mic, losartan 150 mg daily and coreg 25 mg bid). All of the patients were so disabled from heart failure that the initial intent with the LVAD was to use it until they could receive a heart transplant or to leave the device in for the rest of their lives.

“This suggests that even very advanced heart failure can be reversed using these heart pumps, particularly when combined with additional drug therapy, avoiding the need for heart transplantation for these patients and making the donor heart available for another needy individual,” Birks said.

Researchers tested the 36 patients’ heart function to determine if their heart function had improved enough from the therapy to have the pumps removed, or if their heart function remained poor and needed a heart transplant or to remain on the pump. Sixteen patients receiving the combination therapy had recovered enough heart function (after an average of 330 days) to have the pump removed.

“The fact that this could be done in several centers suggests that using the device with this drug combination to reverse heart failure is possible on a larger scale. It has previously been thought that these devices rarely recover heart function enough to allow them to be removed, but this study suggests that this can occur in a much bigger number than originally thought, particularly if combined with drug therapy,” Birks said.

“The next step, we hope, is for more centers to start doing this and then to see if we can potentially add other drugs to further optimize recovery and create a good platform to recover heart function.”