After 10 Years, University Hospitals Continues to Innovate with TAVR
March 25, 2021
Two new clinical trials aim to refine and expand the indications for the procedure
UH Clinical Update | March 2021
Building on 10 years of experience with transcatheter aortic valve replacement (TAVR), interventional cardiologists and cardiac surgeons with UH Harrington Heart & Vascular Institute are launching two new clinical trials aimed at further refining the procedure and expanding the number of people who might benefit from it.
One new trial, dubbed SMART, is evaluating which specific replacement valve is the best option for patients with severe, symptomatic aortic stenosis who have a small aortic annulus, which includes many women. Researchers will compare the valve safety and performance of two self-expanding replacement aortic valves against two balloon-expandable models in these patients, looking at blood flow, mortality, stroke or rehospitalization at 12 months. Patients eligible for this trial will also include those undergoing TAVR to remedy a failed aortic valve that was previously replaced during surgery, a procedure known as a TAV-in-SAV.
“It’s critical to determine which valve is the best option in terms of hemodynamics for these patients,” says UH interventional cardiologist Guilherme Attizzani, MD, Co-Director of the Valve and Structural Heart Disease Center, along with UH cardiac surgeon, Cristian Baeza, MD. In addition, he says, this study will be a valuable contribution to the TAVR literature involving women patients, which historically hasn’t been as robust.
In addition to the SMART trial, UH interventional cardiologists and cardiac surgeons are also studying whether TAVR should be offered to more people with aortic stenosis. In the EXPAND TAVR trial, they will test whether current guidelines for the procedure should be expanded to include people with symptomatic moderate and asymptomatic severe aortic stenosis. These patients represent about 40% of all Americans with aortic stenosis. Researchers will conduct a TAVR feasibility study in these patients, gathering data about blood flow and clinical outcomes.
“There is very little if any data on treating moderate aortic stenosis,” Dr. Attizzani says. “There is some data on treating severe asymptomatic aortic stenosis, mostly coming from the surgical literature, showing that it might be beneficial. These are the questions that this study is trying to answer.”
When answers and study results are available, likely in about a year or two, Dr. Attizzani says they could revolutionize the services he and his colleagues at UH are able to provide for aortic stenosis patients.
“That’s going to be extremely impactful,” he says. “There are going to be a lot of folks out there with symptomatic moderate or asymptomatic severe aortic stenosis not being treated, and we may be able to intervene earlier on and hopefully begin to minimize the negative impact of this disease on their lives.”
A Record of Accomplishment
These two new TAVR clinical trials are just the latest innovations in the procedure at UH. Over the past 10 years, UH interventional cardiologists and cardiac surgeons have pioneered a minimalist approach, performing the procedure while the patient is awake and talking, all while indications for the procedure have changed dramatically. What was once a procedure just offered in a clinical trial for extreme and high risk patients is now offered as an FDA-approved option for patients at low risk. At the same time, as TAVR has evolved clinically, UH experts in the procedure have trained more than 700 fellow providers from all over the world, both in person in Cleveland and virtually, including via six live TAVR cases in 2019 and 25 Medtronic training courses. In addition, TAVR volumes at UH volumes have skyrocketed, from 17 cases in 2011 to 329 in 2019, with a 41 percent increase from 2018 to 2019. Even in the midst of the COVID-19 pandemic, demand for TAVR at UH has remained strong, with 322 cases performed last year. UH has also seen its share of TAVR firsts, as the first program in the world to use the Evolut Pro Plus and the first program in the U.S. to use the Evolut R.
Interventional cardiologist Daniel Simon, MD, and cardiac surgeon Alan Markowitz, MD, were part of the initial TAVR team at UH, launched 10 years ago this month. As they reflect on the last 10 years and look to the future, they’re both proud and enthusiastic about the role UH has played in taking TAVR mainstream – and the role UH will continue to play through ongoing provider training and clinical trials, such as SMART and EXPAND TAVR.
“The TAVR program required an intense collaboration between Cardiology and Cardiac Surgery, pulling us closer in the care of a patient than ever before,” says Dr. Markowitz, who also holds the Marcella "Dolly" Haugh Chair in Valvular Surgery. “There have not been many instances in medical history when both cardiologist and cardiac surgeon become completely interchangeable and interdependent. Because we had always had a good relationship, there was only cooperation, not competition, and the patients benefited directly from teamwork that maximized the results and minimized the complications of a very new technology. The quality of the present program is an extension of what was begun 10 years ago, and I think the sky is the limit.”
“What an incredible journey and milestone,” adds Dr. Simon, UH Chief Clinical & Scientific Officer and President UH Cleveland Medical Center, who also holds the Ernie and Patti Novak Distinguished Chair in Health Care Leadership. “Twelve years ago, Drs. Marco Costa, Alan Markowitz, Ed Avery and I traveled to Portugal to observe and perform our first TAVR cases and jumpstart our TAVR program at UH. This is the most transformative technology of my interventional cardiology career. We have improved the quality and saved the lives of so many patients with aortic stenosis. The best part is that our structural heart team keeps getting better and better. I am so proud of greater than 100 team members!”