Transcatheter therapies have rapidly advanced from clinical studies in extremely high-risk patients to now becoming the standard treatment for aortic valve disease. Two groundbreaking studies published in The New England Journal of Medicine (NEJM) found that transcatheter aortic valve replacement (TAVR) had significantly better outcomes than surgical aortic valve procedures in low-risk patients with severe symptomatic aortic stenosis. Regardless of a patient’s surgical risk, studies over the past decade have demonstrated that transcatheter aortic valve replacement offers a less invasive and safer option for patients who require aortic valve replacement.
In the last two years, the number of TAVR procedures performed annually at Yale New Haven Hospital Heart and Vascular Center (HVC), and across the U.S., has surpassed the number of surgical aortic valve procedures for the first time. Since the technology was first introduced, Yale has been developing novel strategies to reduce complications and leading national and international clinical trials in the field, including the recent studies published in the NEJM.
John Forrest, MD, associate professor of medicine in cardiology at the Yale School of Medicine directs Yale’s nationally recognized Structural Heart Disease Program. “With each new finding, we realize that the potential of these procedures is enormous. We can provide therapies to younger patients who previously weren’t eligible for them, offering these patients a therapy with less risk and one that allows them to recover more quickly.” Forrest adds, that “the aortic valve is just the beginning and before too long we could can expect to see the same thing with diseases of the mitral valve.”
The Next Frontier
Last month, the Yale Structural Heart Team led by Forrest and Arnar Geirsson, MD, chief of cardiothoracic surgery at the Yale Department of Surgery became the first program in Connecticut and the second in New England to perform a transcatheter mitral valve replacement (TMVR) for severe mitral regurgitation. Using a new valve designed specifically for this disorder, the team was able to replace the leaking mitral valve in a patient with a failing heart. As a result of this new technology, patients who are referred to Yale now have more treatment options than anywhere else in the region.
In a given week, the Structural Heart Disease Program performs upwards of ten transcatheter aortic valve procedures, and with advances in both transcatheter mitral valve repair and now transcatheter mitral valve replacement, an increasing number of patients are eligible for these advanced therapies. Ryan Kaple, MD, assistant professor of medicine in cardiology, who specializes in structural heart procedures adds, “The technology is better than ever. Minimally invasive catheter-based therapies have dramatically improved patient care, offering a safe and effective treatment for more patients with quicker recovery times.”
Ongoing TAVR Clinical Trial Research at Yale
Led by Alexandra Lansky, MD, professor of medicine in cardiology, the Yale Cardiovascular Research Group provides clinical research services and scientific leadership that drives cardiovascular medicine forward.
These studies include patients with moderate aortic stenosis and heart failure; patients with asymptomatic severe aortic stenosis; and patients with bicuspid aortic valve stenosis who are at low surgical risk. Forrest serves as the principal investigator for the low-risk bicuspid study, “It has become clear that transcatheter therapies will become the mainstay for valvular heart interventions. This has happened in the treatment of aortic stenosis, and through further clinical studies, we are examining the impact that earlier interventions have on improving patient survival and quality of life.”
A Changing Paradigm in Cardiac Training
In 2015, Yale researchers published the initial evidence suggesting a strong correlation between procedural volume and patient outcomes in patients undergoing TAVR. Subsequent studies found that the best outcomes are obtained by physicians who specialize in structural heart and valve interventions. Yale was one of the first institutions in the country to offer transcatheter procedures specialty training.
This past June, Lindsey Prescher, MD, who completed her fellowship training in Cardiothoracic Surgery in 2018, became the first female cardiothoracic surgeon in the U.S. to complete a GMEC-accredited fellowship in structural heart and valve interventions. Prescher, who is presently a lieutenant commander in the U.S. Navy and as of March 2020, chief of cardiac surgery at Walter Reed National Military Medical Center adds, “Cardiac surgery is a changing field, and to provide the best care possible, surgeons need to be able to offer their patients both surgical and transcatheter therapies. As a surgeon, this means more advanced training, and the opportunity to train at an institution such as Yale, learning from nationally recognized leaders in the field of transcatheter therapies, has given me the skills to provide the best care possible to my patients.”