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Landmark Transcatheter Mitral Valve Replacement Pivotal Trial
Serious heart conditions requiring surgery can be frightening. Dr. Charles Klodell, Cardiothoracic Surgeon at Florida Heart and Lung Institute, discusses the landmark transcatheter mitral valve replacement pivotal trial and how it works.
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Learn more about Charles Klodell, MD
Charles Klodell, MD
Dr. Charles T. Klodell is a cardiothoracic surgeon that specializes in heart and lung surgical procedures including minimally invasive aortic and mitral valve repair or replacement, aortic aneurysm repair, transcatheter aortic valve replacement (TAVR) and open heart surgery. He has a special interest in minimally invasive procedures, valve repair, and innovative uses of technology and pharmacology to alleviate patient discomfort.Learn more about Charles Klodell, MD
Transcription:
Prakash Chandran (Host): Finding out that you or a loved one has a serious heart condition that needs surgery is a really scary proposition. But fortunately, there’s a landmark trial underway around transcatheter mitral valve replacement that provides a minimally invasive alternative to open heart surgery. Let’s talk about it with Dr. Charles Klodell, a cardiothoracic surgeon at Florida Heart and Lung Institute.
This is Helmet of Health, the podcast from North Florida Regional Medical Center. I’m Prakash Chandran. So, Dr. Klodell, what exactly can you tell us about this trial?
Charles Klodell, MD (Guest): Well so traditionally, mitral valve surgery is performed either through an anterior approach where we have to open the chest, open the sternum or through a minimally invasive approach between the ribs where we will often do surgery through a four or five centimeter incision but in this trial, and it’s the first trial of its kind in the United States; it allows patients to have a catheter-based implantation of this valve. And what that means is, we still make a tiny incision, but we make it kind of on the left side of chest right over where the point of the heart would be, and it allows us to insert the device inside the heart and then under a combination of both ultrasound and x-rays; open and expand the valve right in place where we need it to work. It begins working immediately and we can release the valve there once we are confident that it’s secured. The entire procedure can take 25 or 30 minutes and the patients are often ready to go home the next day or the day after. It’s a dramatic difference for patients that qualify for this trial.
Host: Yeah, that’s absolutely incredible. Last year, my dad had a stent put in after a small cardiac event. I’m wondering what exactly this mitral valve replacement is for. Can you talk a little bit about that?
Dr. Klodell: Sure. So, your dad got a stent because he had a blockage in his coronary artery and what they did is go in and put the stent inside to take that coronary artery back to the size it is supposed to be. Similar to if you took your garden hose and you were squeezing the side of it, the flow gets compromised, they have to open it back up to full size diameter of that hose to get the opening back up.
This is a little different. This trial is for people that have an abnormal functioning mitral valve which is the main valve between the top and bottom chambers on the left side of the heart. And it’s probably the hardest working valve in the heart, because it has to support the top number, the systolic pressure. When you hear 120/80, when your heart squeezes to make the 120; the aortic valve is open because it’s letting the blood out of the heart. But it’s actually the mitral valve that has to be closed and holding that pressure. So, in that sense, our mitral valve is our hardest working valve. And when it begins leaking very severely; in patients that maybe aren’t the best candidate for an open surgical procedure; this catheter-based surgery is just a wonderful option for them.
Host: It definitely sounds like that’s to be the case. But up until this point, before this trial, how has this condition been diagnosed and treated?
Dr. Klodell: So, the condition is usually diagnosed by a special ultrasound called an echocardiogram which is when we take the ultrasound probe and look at all the chambers of the heart, look at the function, look at the valves. It would typically have been treated either by being taken to the operating room and having a valve replacement or a valve repair or in people who were not candidates for that; the only catheter-based option was to do a clipping of the valve where we almost take a little clamp that looks like a little alligator clamp and bite the center of the valve to try and force the valve to leak less. That is still a very good option in 2019 and we still do quite a lot of these mitral clippings but in patients that are appropriately selected for the trial; they can have a valve replacement and the big advantage we see with the valve replacement is that at least in the trial so far when we implant these valves; there’s really no leak after we put it in. it makes the valve work essentially 100% at that point.
Host: For those of us that don’t know what the context of a trial means and who can be or who can participate in the trial; maybe talk a little bit about how long the trial has been going on. If I were interested in being part of the trial; how might I go about doing that?
Dr. Klodell: So, clinical trials are all regulated by the FDA, Food and Drug Administration. They are all visible on www.clinicaltrials.gov website so anybody can go on the internet and look it up if they are curious about these kinds of trials. This particular trial is called the Apollo Trial and it’s a trial of the Intrepid Valve. And what it means is if you come to a center like mine; you have an appointment with one of the investigators like me; then we look at what your clinical conditions are and if you meet the enrollment criteria for the trial; which is you have severe mitral regurgitation, you are within certain age ranges, you are not one of the at risk populations meaning children or pregnant women, things like that. Then with the patient’s permission we screen them for the trial. If they meet the screening and enrollment criteria; then they sign a separate consent form and then there are national committees where we present the case and they say yes or no as to whether or not they believe like we do, that the patient qualifies for the trial.
Then in patients that qualify for the trial, then they get a little extra special attention because they are in a clinical trial. There are some extra follow ups. There’s some opportunities to interact with people a little bit more often to make sure they are on the right track and they actually get followed very closely for out to five years sometimes in these clinical trials. So, it’s a great opportunity for patients and it’s a great opportunity for us. We are very pleased to have brought this technology to this area of the country.
Host: Absolutely. It really does sound like you are on the cutting edge of medicine when you are involved in a trial, wouldn’t you say?
Dr. Klodell: I think that’s true. I think in this case, this brings something that has never been in the United States before. Many of the other trials just bring a newer generation or an improved technology. And I tell people it’s like back in the old days when people were driving around with lap belts and then all of the sudden there were shoulder harnesses there. Oftentimes if people introduce a new concept like this, it offers an additive technology that maybe brings more safety and perhaps more efficacy to the patients.
Host: That’s Dr. Charles Klodell, a cardiothoracic surgeon at Florida Heart and Lung Institute. Thanks for checking out this episode of Helmet of Health. Head to FLHeartAndLung.com to get connected with a provider. If you found this podcast helpful, please share it on your social channels and be sure to check out the entire podcast library for topics of interest to you. Thanks and we’ll see you next time.
Prakash Chandran (Host): Finding out that you or a loved one has a serious heart condition that needs surgery is a really scary proposition. But fortunately, there’s a landmark trial underway around transcatheter mitral valve replacement that provides a minimally invasive alternative to open heart surgery. Let’s talk about it with Dr. Charles Klodell, a cardiothoracic surgeon at Florida Heart and Lung Institute.
This is Helmet of Health, the podcast from North Florida Regional Medical Center. I’m Prakash Chandran. So, Dr. Klodell, what exactly can you tell us about this trial?
Charles Klodell, MD (Guest): Well so traditionally, mitral valve surgery is performed either through an anterior approach where we have to open the chest, open the sternum or through a minimally invasive approach between the ribs where we will often do surgery through a four or five centimeter incision but in this trial, and it’s the first trial of its kind in the United States; it allows patients to have a catheter-based implantation of this valve. And what that means is, we still make a tiny incision, but we make it kind of on the left side of chest right over where the point of the heart would be, and it allows us to insert the device inside the heart and then under a combination of both ultrasound and x-rays; open and expand the valve right in place where we need it to work. It begins working immediately and we can release the valve there once we are confident that it’s secured. The entire procedure can take 25 or 30 minutes and the patients are often ready to go home the next day or the day after. It’s a dramatic difference for patients that qualify for this trial.
Host: Yeah, that’s absolutely incredible. Last year, my dad had a stent put in after a small cardiac event. I’m wondering what exactly this mitral valve replacement is for. Can you talk a little bit about that?
Dr. Klodell: Sure. So, your dad got a stent because he had a blockage in his coronary artery and what they did is go in and put the stent inside to take that coronary artery back to the size it is supposed to be. Similar to if you took your garden hose and you were squeezing the side of it, the flow gets compromised, they have to open it back up to full size diameter of that hose to get the opening back up.
This is a little different. This trial is for people that have an abnormal functioning mitral valve which is the main valve between the top and bottom chambers on the left side of the heart. And it’s probably the hardest working valve in the heart, because it has to support the top number, the systolic pressure. When you hear 120/80, when your heart squeezes to make the 120; the aortic valve is open because it’s letting the blood out of the heart. But it’s actually the mitral valve that has to be closed and holding that pressure. So, in that sense, our mitral valve is our hardest working valve. And when it begins leaking very severely; in patients that maybe aren’t the best candidate for an open surgical procedure; this catheter-based surgery is just a wonderful option for them.
Host: It definitely sounds like that’s to be the case. But up until this point, before this trial, how has this condition been diagnosed and treated?
Dr. Klodell: So, the condition is usually diagnosed by a special ultrasound called an echocardiogram which is when we take the ultrasound probe and look at all the chambers of the heart, look at the function, look at the valves. It would typically have been treated either by being taken to the operating room and having a valve replacement or a valve repair or in people who were not candidates for that; the only catheter-based option was to do a clipping of the valve where we almost take a little clamp that looks like a little alligator clamp and bite the center of the valve to try and force the valve to leak less. That is still a very good option in 2019 and we still do quite a lot of these mitral clippings but in patients that are appropriately selected for the trial; they can have a valve replacement and the big advantage we see with the valve replacement is that at least in the trial so far when we implant these valves; there’s really no leak after we put it in. it makes the valve work essentially 100% at that point.
Host: For those of us that don’t know what the context of a trial means and who can be or who can participate in the trial; maybe talk a little bit about how long the trial has been going on. If I were interested in being part of the trial; how might I go about doing that?
Dr. Klodell: So, clinical trials are all regulated by the FDA, Food and Drug Administration. They are all visible on www.clinicaltrials.gov website so anybody can go on the internet and look it up if they are curious about these kinds of trials. This particular trial is called the Apollo Trial and it’s a trial of the Intrepid Valve. And what it means is if you come to a center like mine; you have an appointment with one of the investigators like me; then we look at what your clinical conditions are and if you meet the enrollment criteria for the trial; which is you have severe mitral regurgitation, you are within certain age ranges, you are not one of the at risk populations meaning children or pregnant women, things like that. Then with the patient’s permission we screen them for the trial. If they meet the screening and enrollment criteria; then they sign a separate consent form and then there are national committees where we present the case and they say yes or no as to whether or not they believe like we do, that the patient qualifies for the trial.
Then in patients that qualify for the trial, then they get a little extra special attention because they are in a clinical trial. There are some extra follow ups. There’s some opportunities to interact with people a little bit more often to make sure they are on the right track and they actually get followed very closely for out to five years sometimes in these clinical trials. So, it’s a great opportunity for patients and it’s a great opportunity for us. We are very pleased to have brought this technology to this area of the country.
Host: Absolutely. It really does sound like you are on the cutting edge of medicine when you are involved in a trial, wouldn’t you say?
Dr. Klodell: I think that’s true. I think in this case, this brings something that has never been in the United States before. Many of the other trials just bring a newer generation or an improved technology. And I tell people it’s like back in the old days when people were driving around with lap belts and then all of the sudden there were shoulder harnesses there. Oftentimes if people introduce a new concept like this, it offers an additive technology that maybe brings more safety and perhaps more efficacy to the patients.
Host: That’s Dr. Charles Klodell, a cardiothoracic surgeon at Florida Heart and Lung Institute. Thanks for checking out this episode of Helmet of Health. Head to FLHeartAndLung.com to get connected with a provider. If you found this podcast helpful, please share it on your social channels and be sure to check out the entire podcast library for topics of interest to you. Thanks and we’ll see you next time.