Emory Heart & Vascular reached a significant historic milestone, performing the Transcatheter Aortic Valve Replacement (TAVR) procedure on its 5,000th patient at the end of last year. Leading the way in innovative, minimally invasive procedures is part of the fabric at Emory. The academic medical center was the first site in Georgia (and one of the first in the nation) to perform it in 2007.
TAVR revolutionized treatment for aortic valve disease by allowing cardiologists to replace a patient’s impaired aortic valve with a new prosthetic valve via a catheter. In 2007, it was only available to high-risk patients who were considered too sick or old to undergo open-heart surgery.
Today, TAVR is considered a safer and less invasive alternative to open-heart surgery for many low and medium-risk aortic stenosis patients, according to Vasilis Babaliaros, MD, founder and co-director of the Emory Structural Heart & Valve Center.
Babaliaros has had a front row seat to the rapid evolution and widespread adoption of TAVR. He was the first American physician to go to France and train directly under the renowned Alain Cribier, MD, who invented the transcatheter heart valve and became the first ever to perform a TAVR in the spring of 2002.
During Babaliaros’ introductory meeting with the pioneering physician, he recalls watching Cribier perform the procedure on the 16th patient in the entire world. The experience changed the trajectory of his career.
“Everything I had learned about interventional cardiology up until that point seemed small in comparison,” he said.
Babaliaros and Cribier at the 10-year celebration of TAVR in Rouen, France, May 2012.
Photo courtesy of Vasilis Babaliaros
As an interventional cardiology fellow, Babaliaros learned that aortic stenosis—a narrowing of the aortic valve opening—was typically a death sentence without surgery. Anywhere from 20 to 30 percent of those who suffered from the condition were considered too high-risk for surgery.
As the number of TAVR procedures increased in France, Babaliaros watched Cribier and his team repeatedly and successfully replace damaged aortic valves via a catheter inserted into a blood vessel through a small incision in the groin. The patients were sedated but not put under general anesthesia and the procedure would last as little as 45 minutes. Patients would often be walking a few hours later and could be discharged the following day.
Upon his return from France, Babaliaros joined an already pace-setting cardiology department at Emory with a history for firsts. Emory was the site of the first coronary stent placement in the United States decades ago. Now, he would form a team that would land a place in the first U.S. clinical trial for TAVR.
“It was clear TAVR was going to be a game-changer—it was a landmark jump forward,” said Peter Block, MD, emeritus professor at Emory School of Medicine and Babaliaros’ mentor at Emory.
To win a highly coveted spot in the first-ever clinical trial in the U.S., Block said they put together a multidisciplinary team with people from different specialties across Emory —including cardiologists and cardiac surgeons.
“At that time, it was not common for those specialties to come together,” Block said. “In a very short time with the help and foresight of our cardiac surgeons led by Robert Guyton, we were able to put together one of the best teams in the country, and the whole concept of the heart team changed the way people think about heart care in general.”
The Emory heart team was one of the highest-enrolling sites —Partner I, Partner II, and Partner III—which demonstrated the safety and efficacy of TAVR first on high-risk, then medium-risk, and finally low-risk patients- spanning over a decade in clinical research, 2007 to 2019.
Along the way, TAVR continued to evolve as technology improved. In its early days, the entire procedure was driven by echocardiographic (ultrasound) images. It could be difficult to determine the size of valve to use while monitoring and troubleshooting the procedure as it happened. The transition to using computed tomography (CT) images by 2016 was a leap forward.
“CT scans give us much more high-definition images,” said Patrick Gleason, director of structural imaging in the Structural Heart and Valve Center. “Now we know, before the procedure starts, the exact size of the blood vessels, where any tricky anatomy may be, and the precise size of valve needed.”
The quality of the replacement valves continues to improve as well.
“There is a constant push to come up with better and better devices,” said George Hanzel, MD, an interventional cardiologist at Emory Saint Joseph’s Hospital, which is highly ranked for its TAVR procedure. “The devices are becoming easier to place, more forgivable, more durable. With TAVR, we have not peaked yet.”
And the Emory team itself has grown.
The original Emory Structural Heart and Valve team celebrates the first TAVR implant in the Southeast on September 27, 2007. (Drs. Peter Block and Vasilis Babaliaros are shown in the center.)
Photo courtesy of Vasilis Babaliaros
“Very early on, we decided we wanted to build a valve center to treat all four cardiac valves, not just the aortic valve,” said Babaliaros. “Other centers were carving treatments up between different teams, but we wanted to build a comprehensive center to treat all valves and all structural heart disease. And we did. That has contributed significantly to our success.”
As it evolved, this modern care team, with the addition of Adam Greenbaum, MD, from Henry Ford Hospital, would begin to modify the TAVR procedure to reach more vulnerable patient populations.
Through a unique partnership with Robert Lederman, MD, at the National Institutes of Health, the Emory Structural Heart & Valve Center has been able to provide novel transcatheter options for treatment for the otherwise "no option" patients. They have pioneered a new field known as catheter electrosurgery. By electrifying a wire on the tip of the catheter, Emory interventional cardiologists can use a catheter not just to deliver a new valve but to punch through blood vessels and make incisions, broadening options for patients.
Today, a second generation of TAVR cardiologists face new issues. Isida Byku, MD, an interventional and structural cardiologist, came to train at Emory precisely because of its preeminence in structural cardiology.
Getting to learn directly from physicians like Babaliaros, who have pioneered these new techniques has been a profound experience, said Byku. When she joined the Structural Heart team in 2019, she was struck by how, “procedures have been originated, ideated, and performed here. The overall breadth and depth of exposure and hands on experience our trainees get here is unmatched.”
Byku and her colleagues are focusing on what frontiers are next.
“The challenge for Dr. Babaliaros’s generation was how to make TAVR safe for low-risk patients. They have done that,” she said. “They took this procedure from its infancy and matured it to where it’s essentially now available to anyone. I don’t think this kind of technology advance has been seen in any other medical device in the span of 20 years.”
When it comes to her generation and what’s ahead of them, said, “I don’t know how long these valves will last in younger, healthier patients, so we are looking at how to manage TAVR over their lifetime. These patients likely will live long enough to need the valve replaced one or maybe two or three times, and our challenge is how to best manage that.”
If history is any indication, Emory is up for the challenge.