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Melanie Cole (Host): Transcatheter Aortic Valve Replacement, or TAVR, is a minimally invasive procedure that allows cardiologists and cardiac surgeons to implant a prosthetic aortic valve, and it can provide a treatment option for patients with severe symptomatic aortic stenosis who've been determined by a heart team to be at intermediate risk for open heart surgery. My guest today is Dr. Jesse Jorgensen. He's an interventional cardiologist with Greenville Health System. Welcome to the show, Dr. Jorgensen. So, what is TAVR? Explain to the listeners just a little bit about what this is.

Dr. Jesse Jorgensen (Guest): TAVR is a word that stands for Transcatheter Aortic Valve Replacement or T-A-V-R. That's in contradistinction to surgical aortic valve replacement which requires open heart surgery. With the TAVR procedure, we do this procedure without making a surgical incision. Rather, it's done through placing a catheter, usually in the groin, into the femoral artery and that catheter is advanced up to the area of the heart, much in the same way that a cardiac catheterization is performed, and through that catheter we are able to deploy a new prosthetic heart valve and thereby replace the diseased valve without having to do open heart surgery.

Melanie: So, for whom would this be a procedure that would consider it, and who might be a candidate?

Dr. Jorgensen: Candidates for the TAVR procedure have actually changed somewhat over the past several years. When TAVR was initially approved by the FDA in 2011, it was strictly for patients who were what we call "inoperable," meaning too sick to have traditional open heart surgery, and as the years have gone by, since 2011, it's now approved not only for people who are inoperable, but those who we consider operable, but at either high risk or now what we consider intermediate or moderate risk for complications, and so the number of patients who are now candidates for TAVR has expanded greatly in just the past couple of years.

Melanie: Who might not be a candidate?

Dr. Jorgensen: At the present time, people who have severe symptomatic aortic stenosis who would otherwise need a valve replacement who are not candidates for TAVR would be people who we consider low risk. So, these are people who are otherwise healthy and would be considered excellent candidates for the traditional approach. Those type of patients are currently being tested in clinical trials where the low risk patients are being evaluated compared to the traditional surgical approach. We think that low-risk patients will be candidates for TAVR as those trials are completed within the next one to two years.

Melanie: So, what are the advantages for these intermediate or high-risk patients with TAVR versus the open surgical procedure?

Dr. Jorgensen: The advantages are really from a patient recovery standpoint. People often think about catheter-based or less invasive procedures when we compare them to the surgical gold standard that we're somehow compromising the results or somehow the less invasive procedure won't work as well, but what we've learned is that the TAVR procedure, the catheter-based approach works just as well as surgery from the standpoint of replacing the valves and getting a new valve in the patient that works well. So, it's really not a compromise from the standpoint of getting an excellent functioning valve and a great result. The advantages really come from the patient's perspective from time in the hospital and recovery afterwards. The traditional surgical approach, historically, that involves four or five often many more days in the hospital recovering and then after the patient goes home, it's several more weeks of them getting their strength back and getting on their feet after they've had the open heart surgery. With TAVR, we've adjusted our protocol as we've developed our program over the past five years to where we set the expectation with patients that they're going to go home the next day. So, going home the following day after a valve replacement seems much more attractive to me compared to open heart surgery and spending four or five or six days or maybe longer in the hospital, and then after going home, people are back up on their feet much quicker. We often have patients starting cardiac rehab within a week or two of having the TAVR procedure.

Melanie: Based on the benefits to this procedure Dr. Jorgensen, why wouldn't it be acceptable per se, as of now, for a low risk patient? Wouldn't they want those benefits as well?

Dr. Jorgensen: Most people do; I've never met a patient who walked in saying that they wanted to have open heart surgery, and it can be a very confusing issue for patients, and we have this conversation quite frequently, actually. The reason really is the FDA and what they require for new products and new procedures to be tested, and they're really requiring that the TAVR procedure be tested in that low risk patient population compared to surgery. Most of the people who work in this space believe that TAVR's going to perform very well in the low-risk patient population, but because of the FDA requirements, we have to wait for those studies to come out.

Melanie: Are there certain tests that someone would need to qualify for a TAVR procedure? Do they have to get something like dental clearance?

Dr. Jorgensen: They don't necessarily need dental clearance, but when we see a patient -- when they initially come in for evaluation for valve replacement, it's typically two to three weeks from the time that we initially see them until the time that they get the valve replacement performed with the TAVR procedure. They do have to go through several tests. The important one, and really the initial one that tells us about the valve problems to begin with is what we call an echocardiogram, which is an ultrasound of the heart. By the time we're seeing them, the echocardiogram has already been performed and so the test that we set up in people who are TAVR candidates really amount to two things and that's a CAT scan to look at the heart and determine the size and the shape of that particular patient's valve and that helps us determine what type of valve we're going to use. There's two TAVR valves available, and it also helps us to determine the size of the valve to use. In addition, we're scanning the aorta and what we call the iliac and femoral arteries -- these are the arteries that lead from the groin up into the aorta to determine whether or not that patient has big enough leg arteries to accommodate that catheter that we're putting in, and the second thing is a cardiac catheterization, and the main purpose of this is to evaluate the coronary arteries and if the patient has a significant blockage in one of those arteries. We will very commonly perform an angioplasty and place a stent in the coronary artery prior to the TAVR procedure. So, it's really those two tests: the CAT Scan and the heart cath, and finally patients have to meet with a cardiac surgeon and so these are important members of our heart team and so as cardiologists, we're working very closely with the cardiac surgeons, and the cardiac surgeon’s role in evaluating these patient before the TAVR procedure is really to offer their expertise from a surgical standpoint and determine whether or not a patient qualifies for the TAVR procedure.

Melanie: How would someone know they even have a valve problem in the first place?

Dr. Jorgensen: There's really two ways that people would know. Oftentimes, people are told that they have a cardiac murmur. So, when a physician -- either a primary care doctor or a cardiologist -- is listening to them with a stethoscope, we will often hear what’s called a murmur which is caused by the turbulent blood flow going through the narrowed valve.
The other way that people know is from symptoms, and so sometimes people will develop the symptoms from the valve narrowing, and they may never have been told that they had a cardiac murmur. The typical symptoms that we see are shortness of breath, chest tightness. Sometimes people pass out as a result of the decreased blood flow going to the brain. Sometimes people come into the hospital with congestive heart failure, where they have fluid buildup related to the valve narrowing, but I would say the most common symptoms that we see are people who basically present with what we call exercise intolerance. In our patient population, people often will say that they just give out -- that they are unable to perform the activities that they're accustomed to doing, whether that's working in the garden or a walk on the golf course or walking the dog, whatever it is they're used to being able to do, they're unable to complete those tasks because they're running out of breath, or they are getting fatigued, or they're having to stop and sit down to complete those tasks.

Melanie: And what valves are we talking about? And then what happens to the old valve that's in there once you insert TAVR?

Dr. Jorgensen: We're talking specifically about the aortic valve. The aortic valve connects the left ventricle which is the main pumping chamber of the heart that pumps blood to the brain and all of the vital organs in the body. That valve allows blood to flow from the left ventricle out into the aorta then it closes to prevent blood from flowing back the wrong way, and so with the TAVR procedure, the valves that are FDA-approved that are on the market are specifically designed for that valve. The important thing for all of us to wrap our brains around -- to understand how the TAVR procedure works -- is that it does not require that the old valve be removed, and one of the really nice things about this procedure is -- it's very simple. We place the TAVR valve in its unexpanded or collapsed form inside of that diseased, narrow valve, and as we deploy the new valve, it simply pushes those valve leaflets aside and kind of flattens or pancakes those old diseased leaflets up against the wall of the aorta and because the TAVR valve is essentially a large stent with the valve leaflets on the inside of that stent, the stented part of the new valve functions to keep those old leaflets kind of out of the way.

Melanie: Absolutely fascinating, and tell us, Dr. Jorgensen, about the TAVR program at Greenville Health System.

Dr. Jorgensen: We launched our program in November of 2012 so it was almost exactly a year after FDA approval in the United States. We did four procedures at the end of 2012, and then in 2013, we did about 43 or 44 procedures. The following year, that number was about 80 and then as each year has gone on, the numbers have grown significantly. So, this is a common problem that's out there -- especially as we get older. This is a wear and tear problem, and as our population ages, the need for ways to replace the aortic valve is going to persist, and I think one of the most exciting things about our program is that we've evolved over time.
In the four to five years that we've been doing it, we've really altered how we take care of patients in the hospital. When we first started, people would spend a day or two in the intensive care unit and then they would spend a couple of additional days on the floor in the hospital recovering before going home, and people would often go to rehab afterwards, and one of the things that we're most proud of is that we bring people in for this procedure; they spend one night in the hospital, and the majority of them are going not only out of the hospital the following day, but most of them are going home, and that's really an attractive thing for a lot of people to not only get their valves taken care of, but minimize the time in the hospital and maximize the time that they're at home with their family.

Melanie: So, just in summary, Dr. Jorgensen, wrap it up for us. What would you like listeners to know about the TAVR program at Greenville Health System? Give us your best advice about what people should consider if they're being told that they need a valve replacement.

Dr. Jorgensen: I think people should make sure they're well educated. There's a lot of information on the internet, not all of which is good, but there is reliable information out there through websites like WebMD or Medscape or the Mayo Clinic to read about options for valve replacement and most of the patients who need valve replacement of the aortic valve these days would be candidates for the TAVR procedure or potential candidates, and we're always happy to evaluate people for this procedure even if at the end of the day they are determined to be more appropriate for a surgical approach. I would encourage people if they think they have a valve problem to be aware of the symptoms that can come from it. A lot of times the symptoms are minimized, and people kind of downregulate their physical activity to accommodate for that, and so I’d encourage people to take those symptoms seriously, and it's always better to address the valve issue earlier in the game as opposed to later when more significant problems like heart failure have developed. So, we're always happy to see people in consultations.

Melanie: Thank you so much for being with us today. It's great information. You're listening to Inside Health with Greenville Health System, and for more information, you can go to ghs.org. That's ghs.org. This is Melanie Cole. Thanks so much for listening.