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 team, led by Mark Slaughter, MD, professor and chair of the Department of Cardiovascular and Thoracic Surgery in the UofL School of Medicine and lead cardiothoracic surgeon at UofL Health – Jewish Hospital, performed the implant of the investigational device on Aug. 20.

The artificial heart, Aeson, developed by French medical device company CARMAT, serves as a bridge to transplant for patients with end-stage biventricular heart failure – heart disease affecting both left and right sides of the heart – allowing more time for the patient to receive a permanent heart organ transplant. More than 3,400 individuals in the U.S. currently are awaiting a heart transplant and there are few other treatment options for patients with biventricular heart disease.

“We are excited to provide this new technology to patients in Kentucky and the surrounding region and be one of the first U.S. centers to implant this new total artificial heart” Slaughter said. “This device has the potential to save the lives of critically ill patients suffering from biventricular heart failure who currently have very limited treatment options.”

The new total artificial heart was implanted into a middle-aged man from Southern Indiana with severe biventricular heart failure during a seven-and-a-half-hour surgery. The recipient, whose identity is being withheld upon request, was referred to the Advanced Heart Failure Therapies Program at Jewish Hospital. The patient currently is doing well in the cardiac surgery ICU. The Advanced Heart Failure Therapies Program at Jewish Hospital is the only program in the area that is performing heart transplants, the latest in mechanical circulatory support and cell-based therapies for advanced heart failure.

“Innovative care is what put Jewish Hospital on the world map,” said John Walsh, chief administrative officer at Jewish Hospital. “UofL Health was formed, in part, with a promise to preserve and build on the transplant legacy for generations to come. This procedure is another lifesaving milestone.” 

The new device is designed to solve limitations of left-ventricular assist devices (LVAD), which pump blood in just one chamber, by pumping blood in both heart chambers. Aeson also contains biosensors that detect the patient’s blood pressure and position 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.

“We are honored that our device is implanted at UofL Health – Jewish Hospital, which is recognized throughout the United States for its quality of care and cardiovascular research” said Stéphane Piat, Chief Executive Officer of CARMAT. “I would like to congratulate the teams at Jewish Hospital, the University of Louisville, as well as our technical and medical staff, on this exceptional milestone for both patients and our company.”

The device is medically approved in Europe, where approximately 20 have been implanted. The first Aeson artificial heart in North America was implanted in July at Duke University.

This is not the first time University of Louisville physicians and Jewish Hospital have made artificial heart history. Just over 20 years ago, on July 2, 2001, UofL cardiothoracic surgeon Laman Gray led the surgical team that implanted the first self-contained artificial heart in the United States at Jewish Hospital. The AbioCor artificial heart was implanted into Robert Tools, who lived five months on the device. The UofL surgical team also performed the first heart transplant in Kentucky at Jewish Hospital in 1984.

The unique cell therapy, called FCR001, allows living-donor kidney transplant recipients to stay off immunosuppression drugs they would otherwise need for the rest of their lives.

Immunosuppressants help prevent rejection of the transplanted organ, but can cause side effects, including high blood pressure, diabetes, high cholesterol, neurological effects and increased risk of infection. They also are toxic to the kidneys, causing decline in kidney function over time.

FCR001 consists of stem cells taken from the organ donor and processed at the Talaris facility, then infused into the organ transplant recipient. The goal is to create a durable “dual immune system” (part donor-derived and part recipient) in the transplant recipient. These two immune systems coexist, recognizing both the recipient’s own body as well as the donated organ as self.

Talaris Therapeutics Inc., formerly known as Regenerex LLC, is developing and commercializing FCR001. UofL researcher and innovator Suzanne Ildstad founded the company to commercialize the pioneering work of her team at the university and now serves as Talaris’ chief scientific officer.

“We are very gratified to have reached the milestone of treating the first patient in our pivotal Phase 3 clinical trial as we work to make this therapy broadly available to patients receiving a kidney transplant from a living donor,” Ildstad said. “Thanks to our talented team, investors and the research infrastructure at UofL, we have moved incredibly quickly over the past year to both initiate this trial and to plan additional clinical studies of FCR001 in other indications.”

Last year, Talaris raised $100 million from investors to hire staff and initiate the Phase 3 trial evaluating the safety and efficacy of a single dose of FCR001 in living donor kidney transplant recipients.

In an earlier Phase 2 trial, FCR001 allowed 70% of living donor kidney transplant patients durably to be weaned off all of their immunosuppression treatments. The first patient successfully dosed with FCR001, Robert Waddell, has been off immunosuppressants for a decade with no signs of organ rejection.

“It makes me forget I was ever sick,” Waddell said.��“I feel as healthy as I ever have.”

The Phase 3 trial is expected to enroll 120 adult living donor kidney transplant recipients at multiple sites across the U.S. To date, the trial has been initiated at five clinical sites around the country.

“We are rapidly expanding our network of trial sites, with five sites now active and a planned 10 sites active by the end of this year,” said Scott Requadt, chief executive officer of Talaris. “We look forward to ramping up enrollment across the U.S. as we work to offer living donor kidney transplant patients a future potentially free from chronic immunosuppression.”

More information about the trial is .��

“Three-hundred lung transplants is a significant milestone for Jewish Hospital Transplant Care,” said , director of the Transplantation Program at Jewish Hospital and chief of the division of Transplant Surgery at and the . “We recognize the selfless sacrifice of all organ donors, celebrate the improved lives of our organ recipients, and recognize the impact of everyone on the transplant team for their lifesaving and life-changing work.”

The 300^th lung transplant was performed Tuesday, Sept. 18, on a 71-year-old man from northern Kentucky who suffered from pulmonary fibrosis. The patient was on the transplant list for two months before undergoing a lung transplant. The surgery was performed by , surgical director of the Lung Transplant Program at Jewish Hospital and chief of Thoracic Surgery at UofL Physicians and the UofL School of Medicine.

“Each year, we are performing more and more lung transplants at Jewish Hospital, and it is exciting to hit this milestone as this momentum continues,” said Dr. van Berkel, “When I first started, we were doing between five to 10 lung transplants a year. Now we are closer to 20 lung transplants a year, and we’re trying to grow that even further.”

The first lung transplant at the hospital took place in 1991, and the first double lung transplant in 1995. Since then, transplantation has seen significant advancements in anti-rejection medications, surgical techniques and other technologies, helping Jewish Hospital achieve one-year survival rates higher than the national average.

In 2017, the Jewish Hospital Trager Transplant Center’s program with UofL became the first transplant program in Kentucky, and only the second program in the region, to begin offering Ex Vivo Lung Perfusion (EVLP). EVLP is a leading-edge technology that allows for an expansion of the Lung Donor Pool that will allow more patients to receive lifesaving lung transplants.  

“The Jewish Hospital and UofL transplant team are helping save lives in our community each day,” said Ronald Waldridge, MD, president of . “The team is one of the leading providers of organ transplantation in the United States, and milestones like the 300^th lung transplant remind us how important this work is daily. We’ve come so far since the first lung transplant in 1991, and we’re looking forward to many more lives impacted.”

On Thursday, doctors and lung transplant recipients gathered at the to celebrate the 300^th milestone and the many lives that have been saved over the years thanks to lung transplantation.��

“When I first started my training, we used to have a firm age limit of 65. That was the absolute limit for transplantation,” said , medical director of the Lung Transplant Program at Jewish Hospital and a pulmonologist with UofL Physicians and assistant professor at the UofL School of Medicine. “These days, we are extending that age and our oldest recipient got their lungs at age 75, so we are continuing to push the envelope in terms of being able to offer transplants to older patients, and patients who are sicker who we would not have considered doing a transplant on 5 to 10 years ago.”

Dr. Jill Jacobs is among the 300^th lung recipients at Jewish Hospital. Jacobs was the 271^st recipient, and was also a double lung transplant recipient. Jacobs says she smoked cigarettes for about 40 years, and by the time she stopped, had already developed chronic obstructive pulmonary disease (COPD).  

“I had the transplant in February of 2017,” Jacobs said. “I have been extremely happy and grateful that I had doctors who have given me my life back. They’ve given me a new life, in fact.”

Jacobs said before the transplant, she couldn’t even do simple things, like getting dressed, without being short of breath. She says the has helped change her life.

“I can’t tell you how happy I am that I went to Jewish to have this done,” Jacobs said. “It’s a gift nobody can believe. It’s a miracle, in my opinion. A miracle.”

Earlier this year, the Jewish Hospital Trager Transplant Center – a joint program with the UofL Physicians, the UofL School of Medicine and KentuckyOne Health – also celebrated its 500^th heart transplant. In addition to Kentucky’s first heart transplant, the program is known for performing Kentucky’s first adult pancreas, heart-lung and liver transplants.

Thanks to a pledge of $1.05 million throughout five years from the GSG III Foundation Inc., the UofL School of Medicine will create the Gibbs Lung Research Program at the Cardiovascular Innovation Institute (CII). The program will use established research and existing partnerships at CII to develop improved methods for studying diseased lungs and to explore new treatments for inflammatory lung disease.

“Given the number of people in Louisville and Kentucky who suffer from lung diseases, from COPD to cystic fibrosis to asthma, we are happy to support the community by creating a program that can ultimately lead to life-changing therapies for the people of Louisville and across the United States,” said George Gibbs, chair of the GSG III Foundation, which is based in Louisville.

Lung disease is the third leading cause of death in the United States, with chronic obstructive pulmonary disease (COPD) alone affecting 13.5 million people. Inflammation of the lungs is often the first sign of more serious lung disease. However, scientists have limited methods for studying inflammation in lungs to better understand how and why it occurs and to develop treatments.

“Other than lung cancer, most people do not understand the extent of the problem of lung disease,” said Laman Gray Jr., MD, executive and medical director of the CII. “Inflammatory lung diseases are debilitating and affect millions of individuals. What is worse is the scientific world has limited capabilities for studying these diseases. This gift from the GSG III Foundation will allow us to develop expanded modeling opportunities with the goal of reducing human suffering from lung disease.”

More than 70 percent of donor lungs are unusable for transplant. Support from University of Louisville Hospital and Jewish Hospital, both part of KentuckyOne Health, will enable the program’s investigators to obtain donated human lungs that cannot be used for transplant. Researchers in the new program plan to develop techniques to sustain these donor lungs over a longer period of time, allowing them to study the causes of inflammation as well as test potential therapies.

The goals for the program are three-part:

1. Establish an ex vivo human lung model allowing lungs that are unsuitable for transplant to be brought to CII for research. The donated lungs will be enclosed in a sterile plastic dome, attached to a ventilator, pump and filters. The lungs will be maintained at normal body temperature and treated with a bloodless solution containing nutrients, proteins and oxygen.
2. Develop methods for long-term support of the ex vivo lungs. Current processes enable the lungs to be supported for up to 12 hours, which is long enough to transport them for transplant, but not long enough for meaningful study.
3. Once these techniques are in place, researchers in the program intend to use the research models explore areas of potential benefit, including:

• Cell therapy – Explore the use of stem and regenerative cells isolated from a patient’s own fat tissue to treat lung inflammation.
• Mechanics – Develop improved methods of respiratory support by studying the biomechanics of diseased lungs and the benefits of ex-vivo lung perfusion, a method of strengthening lungs outside the body.
• Gene expression – Understand the course of dysfunction and dysregulation among the more than 40 different cell types within the lung and profile the functional changes that occur in diseased lungs and compare the gene expression to healthy lungs.

The program’s investigators will include Gray, James B. Hoying, PhD, division chief, cardiovascular therapeutics, Stuart K. Williams, PhD, division chief, bioficial organs, George Pantalos, PhD, professor of surgery and bioengineering, Victor van Berkel, MD, cardiovascular and thoracic surgeon, and Shizuka Uchida, PhD, associate professor of medicine, all of UofL.

UofL researchers hope the Gibbs Lung Research Program ultimately will become a comprehensive lung research program, leading to valuable treatments that will slow or reverse the course of lung disease, improving quality of life for millions of people.