Courtesy of Washington University
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The standard treatment for patients with low-risk aortic stenosis, when the aortic valve in the heart stops functioning properly, is open-heart surgery. But for some patients, that operation is too risky.
Enter the minimally invasive transcatheter aortic valve replacement (TAVR) surgery, which as of last month, has been approved by the FDA. Washington University and Barnes-Jewish Heart & Vascular Center were one of the sites for this (and the two previous) nationwide PARTNER (Placement of Aortic Transcatheter valves) clinical trials for TAVR. In fact, Washington University physicians were the first in the St. Louis area to perform this breakthrough surgery and has since performed over 1,000 TAVRs, more than any other center in the region.
During the procedure, “a wire passes inside the patient’s body—typically from the leg,” says Dr. Hersh Maniar, a cardiothoracic surgeon part of the Heart Center team. “That wire is then passed across the narrowed and diseased aortic valve. The new valve is basically loaded onto that wire and then positioned inside the diseased aortic valve and expanded. It’s either expanded by a self-expanding metal mechanism or with the use of a balloon. It anchors in place and pushes the old diseased valve out of the way. The surgery takes around an hour and patients usually can leave the hospital after one or two days.”
In 2007, Dr. Alan Zajarias, an interventional cardiologist on the team, experienced one of the highlights in his career when he traveled to France to train with Dr. Alain Cribier, a French interventional cardiologist credited with performing the first human TAVR surgery in 2002. Zajarias traveled back to St. Louis bringing Cribier and what he had learned with him. He, along with Dr. John M. Lasala and Dr. Ralph Damiano Jr., performed the first TAVR surgery at Washington University in 2008 while Cribier proctored it. This led to the university becoming a site for the PARTNER TAVR clinical trials—chosen because of their “excellent track record for successfully performing valvular surgeries,” explains Maniar. Lasala and Damiano served as the local principal investigators for the first PARTNER’s study. Then, Zajarias and Maniar took over for the second and third studies.
“PARTNER I started in 2008 with high-risk and inoperable patients,” says Dr. Marc Sintek, another interventional cardiologist on the team. “For patients traditionally considered inoperable, results showed about a 50 percent reduction of death with those who had TAVR surgery compared to doing nothing. For high-risk patients who either had TAVR or open-heart surgery, results showed that both procedures had similar outcomes. In 2012, FDA approved TAVR for high-risk patients.”
These positive outcomes led to TAVR to be tested in the same manner with intermediately-risk patients in the PARTER II study. This resulted in similar outcomes with the high-risk patients, which led to FDA approval in 2016 for intermediately-risk patients.
Finally, PARTNER III studied TAVR in low-risk patients. Again, patients either had open-heart surgery or TAVR. “Results showed that those who had TAVR had superior or the same outcomes as those who had had open-heart surgery,” Sintek says. Consequently, the FDA expanded approval for using TAVR for low-risk patients last month.
With FDA approval, people now have an alternative insurance-covered treatment. However, the physicians want to stress that TAVR may not necessarily be the best option for everyone.
“Some patients’ anatomy is better suited for open-heart surgery; others will be better suited for TAVR,” Maniar says. “If the anatomy is equally good for either procedure, then we typically choose the less invasive one because it leads to a potentially easier recovery.”
If diagnosed with valvular heart disease such as aortic stenosis, Sintek says “an interventional cardiologist and heart surgeon will meet with the patient at the same time for an initial consultation and both doctors will perform TAVR if that is what is best for the patient. We have a multidisciplinary team who meets once weekly to discuss the patients and decide what’s the right therapy for them.”
“It is very satisfying to know we are writing the history books instead of just reading the history,” Zajarias says of the procedure’s impact on modern medicine. “It is incredibly satisfying to see patients come in for a lifesaving procedure and have them return to their families and their activities that they enjoy the most in no time.”
