Lars Svensson, MD, PhD, Cardiovascular and Thoracic Surgeon, Chairman of the Sydell and Arnold Miller Family Heart & Vascular Institute at Cleveland Clinic talks about a new biological heart valve option that gives younger patients in need of a new valve another option.
Interview conducted by Ivanhoe Broadcast News in January 2018
So, let us just start off with you telling us a little bit about this new valve?
Dr. Svensson: This is a very interesting valve that we have had a lot of interest in for a while because first of all the technology is something that we worked on. The basic idea for the leaflets was to have a tissue storage method that allowed for dry storage, so you then save on weight, on shipping on the valves, and potentially the valves have a longer period of shelf life before they have to be discarded. Now we have such a high turnover of valves so that really would not be too much of an issue. The second part is that the technology allowed for extracting more fat out of the leaflets and potentially better durability over time and the animal research sites clearly showed that these valves were holding up much longer in animals, and animals tend to destroy valves quicker than humans so that was the one positive aspect. Then we had also noticed that when we were putting what we called valve and valve we got better and better, we are doing the valves through the groin, the percutaneous valves or through the chest wall. We noticed that in patients who had a previous valve replacement including the mitral valve position, but also the aorta valve position we had used the model of valve that had an expanse aisle base to it, so that happens to be a valve we have been using since 1983 and we have put in over 13,000 of these valves. Some of those patients are coming back, say 15 or 20 years later needed another valve and when I would put in a new valve, and expand the new valve, the TAVR valve. In the old valve I noticed that the rubber at the base would sometimes pop or I can feel it give and expand, and so I mentioned to the board of directors for that technology and the CO, this is something to think about. So, the new valve has built into it now and the frame the ability to expand so this little silver latch or sliding mechanism on and it still has a bit of a rubber band, but that also gives if you do a valve in valve. There were two important reasons why this valve would be good to try and that is why we ran the study of over 600 patients across the United States and that resulted in developing and approved by the FDA at the end of last year. As of last week I then started putting them in patients. I have put in about nine of these valves and they are working very nicely. It is going to be a long time before we know how effective this valve is as far as durability. Now, from the original series over 600 patients of which was called a commence trial we know that three years later the valves are holding up very nicely and we deliberately tried to put them into younger patients with the idea of how is this valve going to hold out in the long term. So this is very promising and it is going to take ten to 15 years before we really know if the durability is better than the old valve and the standard valve that we have, which is actually very good as far as durability. But then in addition, it will have this expanse all ability, which would be a big plus for down the road when we do valve and valve TAVRs.
Okay, and who is the ideal patient for this type of valve?
Dr. Svensson: That is a good question, but not easy to answer, because the general recommendations are for patients under the age of 65 they should have mechanical valves, over the age of 65 the companies generally say that 20 years after surgery 80 percent of those valves are still working. So in the older population it is not quite so important, but in the younger population of patients who do not want a mechanical valve that want to have a biological valve for example, the really young patients planning a pregnancy or patients who would potentially will cut themselves, for example, yesterday I was talking to a fellow who works with gas lines, and installations of gas into hoses; he is always hammering things, cutting themselves, so he is not interested in having a mechanical valve because he cuts himself on a regular bases, he just cannot afford to be in the position, so there is another kind of person who would like a biological valve and then there are sportsmen to. Having said that, there are a lot of patients out there who are also getting a replacement valves, who could have aortic valves and as we know also mitral valves gets replaced and unfortunately, some of those patients are ending up with mechanical valves who could have benefited from having the valve repair and if they could not have it repaired then by having a biological valve we hope that this valve would fill a niche there for the younger patient who want a more durable long-term valve potentially, but also the ability to have valve to valve down the road.
Okay so the biological valve is an advantage for younger patients because they do not have to be on blood thinners. Since they are more active they will be doing things that will be putting them at risk if they have a mechanical valve?
Dr. Svensson: Yes that is true. Any patient who is at risk from bleeding, being on the blood thinners, would benefit from having a biological valve. Or for example we have patients who come in who need another major surgical procedure and there may be reason then to put a biological valve in those patients rather than a mechanical valve and then they have to be on Coumadin for that.
Okay, so the mechanical valve is usually put in younger patients because it lasts longer?
Dr. Svensson: Yes so the mechanical valves, the one that we use a lot, we have been using since 1973 and several million patients now have had that valve put in. It is very durable, it does not wear out, there can be tissue grown into it. Some of the newer mechanical valves, bi-leaflet valves, they have some protection against tissue and growth and then one of the new ones, also we potentially can run the patients that are low on Coumadin level, which has some advantages also; but essentially they do not wear out. All patients who have disease valve, bicuspid valves or who have a valve replacement do have some risk because the valves do get infected, so that does not really change between a biological valve versus a mechanical valve, they both have about the same risk of infection. For example, someone has a dental cleaning and they do not get antibiotics then they have an increased risk of ceding their valves from the dental cleaning and organisms in the mouth going to the valve.
Interesting, and why is having this new valve option important for patients?
Dr. Svensson: So the two big reasons that would be important for them potentially is the long term durability and then if they need another valve, there will be an optional going in through the groin and putting in a new valve inside the previous one, this exospheric valve and that looks like it would be certainly something feasible and promising.
Alright, now let’s talk about Carrie a little bit. What was her condition before she had the valve replacement?
Dr. Svensson: Carrie has had an abnormal valve since she was born. She was born with a valve with essentially two leaflets, what is called a bicuspid valve and she had in the last year or so becoming increasingly short of breath and what happens with these valves when they give in, the two main groups of problems arise. One is the valve starts leaking and that typically presents in patients getting short of breath and tired, it may not show up as early as the valves that narrow down, but when it shows up; it usually is shortness of breath. Occasionally, it would be a chest pain, occasionally dizziness and then often X-ray, or a CAT scan, or an echo, if sent to an echo for a murmur they seem to have big hearts. Now, the other thing that happens to these inherited congenital bicuspid valves is that they narrow down and so calcium builds up on them, and then you have a restriction of flow. The restriction of flow can be to the point where the heart is trying to pump blood out through a hole that is the size of a pencil or pen, so very tight little jet has to get forced through that and that causes problems. Obviously, the patient’s blood pressure is not as good, so the consequences of that is that the patients typically presents with shortness of breath, chest pain, dizziness, or even passing out; so those are things that can happen when the valve narrows down.
One more question, if you could explain how the valve helps Carrie?
Dr. Svensson: So in Carrie’s case because she has this congenital abnormal valve, she now has a good competent valve that neither leaks nor is narrowed down, and we were able to get a pretty good size into her so she will be a candidate for down the road if the valve should fail to get another valve put in and hopefully being young this new valve will also have much more durability than the other options.
Great, is there anything we missed that you think is important to know or mention about this?
Dr. Svensson: The problem Carrie had is mainly a leaking valve and not a valve that is narrowed down. With the leaking valve our first choice is to try and repair those valves and we have had excellent results for that getting through the operation. Long term the repairs we do on the bicuspid valves are really holding up very nicely and we’ve got data now that with the newer techniques we use the most recently operated patients are doing even much better the historically of series of patients we did previously. So we just published now the largest series of aortic valve repairs in the world and hopefully surgeons will pick up on the some of those techniques and so certainly we have surgeons here and we do a lot of these repairs. Last year I think we probably did close to a 150 aortic valve repairs, just repairs alone, we see a lot of patients where we can repair valves for them.
Tell us a little bit about how this has improved Carrie’s quality of life?
Dr. Svensson: We will see how Carrie’s quality of life improves, obviously she just had the procedure and we did it through a keyhole so through a small incision and she will be able to go back to work in two to three weeks, and spend time with her kids and sons. Her recovery is much quicker with a small incision and she should start feeling pretty quickly that she can breathe better and her stamina, her ability to handle stress and exercise, will be a lot better and over time she will see a continued improvement in quality of life and shortness of breath was her main symptom; so we expect that will be a lot better for her.
END OF INTERVIEW
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