Innovation resident plays key role in groundbreaking heart device research

When Dr. Trenton Gluck entered the general surgery residency in the innovation track at Baylor College of Medicine, he was eager to pursue a career in heart surgery, confident that Baylor was the ideal place to foster his passion. However, he never anticipated that his path would lead him to working on a breakthrough device, the BiVACOR Total Artificial Heart (TAH).

“Besides the amazing opportunity to work with these world experts and get this incredible experience while just a resident, this is an opportunity to change medicine,” Gluck said. “There are limited hearts available for transplant. And those that are transplanted don’t last forever. These people are on a clock. If we could give them something durable — potentially for the rest of their lives — it could really change heart disease as we know it.”

The BiVACOR TAH is a compact, implantable device that replaces both ventricles of a failing heart, restoring blood flow to the body and lungs. Unlike traditional artificial hearts, it has just one moving part — a levitated rotor suspended in an electromagnetic field — eliminating valves, mechanical bearings and friction. This design could allow the device to last indefinitely, making it a groundbreaking solution.

Gluck was involved in early preclinical studies, testing the device and also compiling and synthesizing all the information gathered from initial trials to submit to the FDA for approval for human trials.

“The amount of effort it takes to get to the point where you can try something like this in humans is monumental,” said Dr. William Cohn, professor in the Division of Cardiothoracic Transplantation and Circulatory Support at Baylor and chief medical officer at BiVACOR. “It’s a Herculean task — and it’s building on all the progress that came out of The Texas Heart Institute at Baylor College of Medicine and the Texas Medical Center from geniuses like Dr. Bud Frazier and Dr. Michael DeBakey.”

History of BiVACOR TAH

Daniel Timms, an Australian engineer, began developing the device alongside his plumber father, often visiting the local hardware store to experiment with prototypes. His father’s death from heart failure deepened Timms’ resolve to bring the artificial heart to life.

Through his work, Timms connected with Dr. Bud Frazier, who had pioneered novel assist pumps with similar turbine and rotor technologies. Cohn, Timms, Frazier and a team of dedicated researchers and engineers tested and refined new versions of the device. Their collaboration led to a series of successful animal trials resulting in increasing survival rates.

This is when Gluck joined the team and continued trials with the team.

“I had to understand how the device functioned, how to manage it, and what day-to-day care was required to ensure a successful implantation,” Gluck said. From those studies, Gluck helped compile critical data needed for FDA approval to move forward with human trials.

Preparing for human trials

With experience not many others had, Gluck played a critical role in preparing surgeons, intensivists, nurses and all clinicians who would potentially encounter a BiVACOR TAH patient for human trials. “Because I had seen the device in action for so long, I could share that knowledge with the people who’d be treating patients,” he said. Gluck helped develop a clinical training program and visited sites that were approved to implant the device with Cohn. In addition, surgeons came to Houston to train and learn before they would implant the device.

Decades of effort culminated in July 2024, when the first human received the BiVACOR TAH at Baylor St. Luke’s Medical Center in Houston. The 58-year-old patient, suffering from end-stage heart failure, lived with the device for eight days before receiving a donor heart.

“It was a huge success,” Gluck said. “The patient did well. But then came the next challenge — could we do it again?”

Four more patients followed in the FDA’s Early Feasibility Study. All five received transplants, and the study has since been approved to expand to 15 participants — some of whom will be able to go home with the device.

Another huge milestone happened recently in Australia, where a patient lived at home with the BiVACOR TAH for over 100 days.

Preparing for what’s next

The BiVACOR TAH is currently being tested as a “bridge-to-transplant” device, with plans to seek FDA approval for broader use in the next few years. Eventually, the goal is to offer it as a long-term solution for patients who may never receive a transplant.

Heart failure is one of the leading causes of death in the United States, claiming about 130,000 lives annually — a number that has remained stubbornly high for decades. Meanwhile, only around 3,500 patients receive heart transplants each year, and thousands more remain on waiting lists with no available donor in sight.

By Tiffany Harston, senior communications associate in the Michael E. DeBakey Department of Surgery