TAVR: The research that changed open heart surgery

For every lifesaving medication, therapy, procedure and device available today, we have research to thank. Baylor Scott & White has a deep and rich history conducting medical research across a number of areas. Our researchers have been involved in conducting the research and gathering the data that helps bring promising new options to life.

One of our many long-standing research labors of love has been TAVR, transcatheter aortic valve replacement. For 20 years, we have been involved in clinical trials around this promising alternative to open-heart surgery for patients with aortic stenosis, or a narrowed aortic valve that fails to open properly. The fruits of research labor were seen most recently in the Food and Drug Administration’s approval of the use of TAVR in patients considered low surgical risk. With this approval, TAVR officially became an option for patients in all risk categories.

Extensive research is naturally a critical factor to seeing these new options such as TAVR introduced to the public, but the people involved play the greatest role. Without research staff and research volunteers, the research itself could not be done.

What follows below is an inside look at the research process, from the perspective of a research team member, Margarite Grable, and the perspective of a TAVR clinical trial participant, Kay Harris.

Listen to the conversation between Margarite and Kay as part of Beyond the Lab, a podcast hosted by Baylor Scott & White Research Institute.

From the research bench

Featuring Margarite Grable, research team member

How did you get involved in clinical research?

I’ve been working at Baylor Scott and White now for 11 years. I started out working in cancer research doing phase one trials. In 2013, I started working in cardiology research and I’ve been in this position ever since working with an amazing, wonderful, fabulous team of researchers. It’s where I belong.

What does the process look like to enroll in a study?

We do quite a bit with potential participants to ensure we are addressing any questions or concerns they might have. We sit down with the patient and usually their family and walk through the entire consent form, which goes through the components of the study, including what is involved with their participation, what screenings are involved, what type of ongoing visits or milestones might be involved, as well as the reported benefits and risks of the study. We bring in the physician involved to answer any of their questions and we encourage them to go home with the informed consent paperwork so they can review it more closely and write down questions that they may think of later.

We then invite them back to talk through those questions and revisit all the specifics of the trial so they feel comfortable with the details before signing anything.

“I get great job satisfaction knowing that I am part of the research process to advance medical science and to bring new drugs, treatments and devices to people like Kay so that patients can live longer, happier, healthier lives.” –Margarite Grable

This TAVR study was a “randomized” study – what does that mean?

That means that participants are randomized — truly picked at random — to either get the standard treatment or procedure for their condition, or to get the treatment or procedure being studied through the clinical trial. We want to make sure patients in randomized trials understand there is no guarantee they will get the “new” option because we need to keep the variables balanced and the data sound between the standard option and the clinical trial option.

We have a big, strong team who supports the patient and supports the study, and makes sure that all the questions are answered — and that the patient is very well informed.

What happens if you change your mind about participating?

Participation is always voluntary. We make the study team accessible and do things like provide business cards with our numbers so participants can reach out with any questions at any time. If a patient decided they didn’t want to continue participation, that’s absolutely acceptable.

How closely do you follow participants in a study?

We follow them very closely with all trial-related components. We schedule their appointments, we monitor their progress and we see them at every check-in or trial appointment. The clinical research team, along with the principle investigator and sub-investigators, we are a team — we ensure each participant is closely monitored because in clinical trials, safety is our number one priority. 

It’s absolutely a journey that we go through together.

What is TAVR?

TAVR is actually a medical procedure that involves a medical device to repair the aortic valve. TAVR stands for transcatheter aortic valve replacement. For participants randomized to receive the TAVR procedure, doctors went through the femoral artery to repair the aortic valve instead of the standard procedure that has been in use for decades, which is open heart surgery. 

How does TAVR compare to open heart surgery?

Because TAVR is less invasive and doesn’t involve standard open heart surgery, procedure duration and recovery are different from the standard. TAVR is about a 45 minute to 1 hour procedure, and in most cases patients can go home by the next day. For open heart surgery, also known as SAVR (surgical aortic valve replacement), it’s naturally a much longer procedure because it is true open heart surgery. Recovery time in the hospital can be closer to 7-10 days in addition to extension rehabilitation. 

Why are you passionate about research?

I get great job satisfaction knowing that I am part of the research process to advance medical science and to bring new drugs, treatments and devices to people like Kay so that patients can live longer, happier, healthier lives. In the case of TAVR for example, our TAVR program is robust and we’ve been doing research for almost 20 years across the system. I’m honored and I feel very fortunate to be in this position and to interact with patients like Kay every day. It’s wonderful.

I just want to add that medical discoveries are not possible without the participation of volunteers — that’s very important to remember. Every medication, every device, had to go through clinical trials before it was approved. We can’t conduct clinical trials without the patients who volunteers for us. That’s why I’d also like to thank Kay for her participation. She’s been a great research participant. It’s been a joy to work with her.

From the patient bedside

Featuring Kay Harris, TAVR research participant

How did you feel going into this study?

When you get into a situation where the body is in decline for one reason or another, then I think in today’s world with so much at our fingertips, you can’t outthink the doctors and you can’t outthink the researchers through the internet. I’m not an internet person, but I’m a trusting person. And I felt like it was a very positive setting.

What would you say to someone considering participating in a clinical trial?

I strongly suggest people relax and go with the flow. Let the people do what they know and they love to do, and treasure the support of all the ones around them.

“I feel like I am on an upswing. We don’t know what the future holds, but hey, it’s good.” –Kay Harris

How are you feeling today?

I feel like even though you can see a little bit of the aging in my face, my body as a whole is healthier. I’m more firm when I get in and out of a car, when I get out of bed, when I plan my day, my week, my life. I feel like I am on an upswing. We don’t know what the future holds, but hey, it’s good.

I had to rethink me. You know, now I am walking, I am doing weights, I’m eating food of color. I’ve just had to learn there’s a new me that needs to be healthy.

How does it feel to help advance medicine through research?

It’s today’s world. It’s a positive, ongoing learning. People of all backgrounds, all educational levels can benefit from the exploring. I’m glad to be a part of it. I feel complimented to be a part of it and I hope it helps.

Inspired by our patients, we challenged nine local artists to create nine unique works of art that tell their powerful stories of healing and recovery. See how a local artist brought Kay’s story to life through a piece titled “Legacy.”