“It is remarkable how our team of pediatric specialists came together with the device company to offer a resolution for such a small patient weighing less than three pounds at the time of implant,” said Soham Dasgupta, pediatric electrophysiologist, Norton Children’s Heart Institute, and UofL assistant professor of pediatric cardiology. “This case is unlike any other and we are so pleased to see this patient thriving as a result of the innovative approach.”

Approximately 1 in 22,000 infants are born with CCAVB. Untreated, the condition has a high incidence of prolonged illness or death. The usual treatment involves implantation of a pacemaker once the patient meets a minimum body size, typically 4.5 to 5.5 pounds, to accommodate the implantable device. Taking time for the baby to grow while being otherwise treated is strongly preferred for this situation. With this patient, however, the traditional plan was not working.

“In this instance, the patient was not of the optimal size and medical/conservative management was unsuccessful, so a specially modified pediatric-sized pacemaker also known as an implantable pulse generator (IPG) created by Medtronic was used,” Dasgupta said.

Dasgupta and his colleague, Christopher L. Johnsrude, director of pediatric and adult congenital electrophysiology at Norton and UofL associate professor of pediatric cardiology, reviewed the relevant preclinical data from a procedure where a similar tiny pediatric IPG had been implanted in an adult Yucatan miniature pig, an animal with a heart that resembles a child’s heart.

Once it was determined the pediatric IPG was potentially compatible with the patient at Norton Children’s, Dasgupta worked with Norton Children’s Research Institute, affiliated with the UofL School of Medicine, and the manufacturer, to obtain local Institutional Review Board approval and emergency authorization from the U.S. Food and Drug Administration. 

The procedure to place the implant was completed over the course of a two-hour open-heart surgery. The tiny device measures 1.16 by 0.65 by 0.38 inches and weighs 0.18 ounces.

“While the operative steps might be comparable to the usual pacemaker implantation surgery, this surgery was especially delicate due to the very small size of the baby,” said Bahaaldin Alsoufi, chief of pediatric cardiothoracic surgery, co-director of Norton Children’s Heart Institute, and UofL professor of cardiothoracic surgery. “This tiny pacemaker generator was positioned in the abdominal wall on the right side and was connected to the usual leads that were attached to the heart.

“This novel device will provide the necessary support that the baby currently needs. At time of repair of the patient’s congenital heart defect in the future, we will be able to utilize these same leads and likely connect them then to a traditional larger pacemaker generator.”

To date, the patient is doing well and continues to be cared for by cardiac and neonatal specialists across Norton Children’s Heart Institute.

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.