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Mitral Clip: Transforming Heart Surgery – In-Depth Doctor’s Interview

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Swedish Heart and Vascular doctors, Santanu Biswas, Sameer Gafoor, Sidakpal Panaich talk about transforming heart surgery with a mitral clip.

Interview conducted by Ivanhoe Broadcast News in 2023.

We were talking to your patient, Mr. Arlington Carter and he was telling us about his initial symptoms which he presented to his GP, which referred him to you. He said he was very out of breath, just even walking to his mailbox and he knew something was wrong. Can you add to the story?

Biswas: Sure. When Mr. Carter was referred to me, his main complaint was shortness of breath, meaning that he was unable to do things that he normally does and he would get more short of breath when doing that. The classic symptom is say you walk to your mailbox. Even at his age, most people think, it’s hard to do it, but he was getting very short of breath, just walking a few feet. This is a person who has historically been a pretty active lifestyle. He goes to the symphony and he plays golf. He also was complaining of fatigue and tiredness as well. That’s why he was referred to me, to see if there was something heart-wise that was potentially contributing to his symptoms.

What did you discover?

Biswas: The evaluation of shortness of breath can be a lot of different things. Many people at their age, oftentimes thinks that it is just a function of their age. A lot of people say,  ‘I’m in my mid-’80s that’s what I’m supposed to feel like.’ We did an echocardiogram which revealed that he had a leaky valve, medically called a mitral regurgitation. It was pretty severe, so I felt reasonably sure that this might be a cause or at least a contributor to his symptoms.

Why leaky valve, because in some cases can’t you just do a classic corrective open heart surgery on it?

Biswas: Once we discovered that he had a leaky valve, the next question is what to do about it. If you asked us about 10 to 15 years ago what we could do about this, we would say that he would need open heart surgery. Unfortunately, once you get above 80, the risk of something bad happening during or even after the surgery becomes much higher. In addition, even if the surgery goes well, there’s a very long recovery period, and it may be months or even up to a year before people start feeling better. Many surgeons don’t like to operate in the mid to late ’80s because of these issues and the concerns for infections, bedsores, and things like that.

Without this mitral clip, what were the options? Would it be to try and live as comfortably as possible?

Biswas: Again, if you asked us 15 years ago and someone who was not strong enough to withstand the rigors of the surgery, we would say to treat it medically. We would give them pills to remove excess fluid and what eventually happened is they would have a slow deterioration. Over the next couple of years, they would have good days and bad days, but over time, the bad days would outnumber the good days. That was the reality for a lot of patients in this situation. The mitral clip really revolutionized how we treat this condition. People are living into their ’90s regularly now, and surgery still is difficult for these people to go through and they have lots of conditions that, if treated, would give them a very good quality of life. The mitral clip is one of those therapies. We are very fortunate to have an effective therapy for people in their late ’80s and beyond, to preserve that quality of life and even extend life.

Mr. Carter’s, leaky valve two open heart surgery, what happens next?

Biswas: Back in the old days, the way it worked is if you had a leaky valve, you get to the surgeon, they would open you up and they would just fix it. You didn’t really care about the details, the surgeon would just open you up, see what he needed to do or she needed to do, and then take care of it. The mitral clip’s a great device that brings up the, I want to start over. The field of structural heart disease has exploded. We’ve had lots of new technologies that have allowed us to do minimally invasive things, but since we can’t open people up or since we don’t want to open people up, that means we have to plan for these procedures in a much more detailed fashion. That does require a lot of tests, but we have expertise in those tests and once we plan appropriately, we feel very confident that we can get a good result out of these minimally invasive techniques.

Can you break down the procedure?

Biswas: Most of these procedures, at least those that was involved when do not open up the chest or do not do any kind of cutting other than a little incision for a big IV. That’s pretty much it. Because of that, we do have to plan for these procedures appropriately. These involve diagnostic tests. There’s a test called the TEE procedure, where we go down the mouth into the stomach to take a look at the heart, allows us to get measurements of the valves, allows us to get measurements of ventricles, and different structures, allows us to plan where we put the clips. Sometimes we’ll get a CT, which again, allows us to get better measurements. Because we’re working in small spaces because we have certain sizes, we want to make sure that we can fit the right device in the right place and that the patient’s heart is able to accommodate that.

Tell me how the clip goes through the groin, etc.

Biswas: The clip is inserted through a small incision in the groin. That incision through the groin will access a vessel called the femoral vein. The femoral vein is different from the femoral artery. It is a much lower-pressure vessel, and there’s a much lower risk of complication than the femoral artery. We snake this device up through the femoral vein, up through the inferior vena cava, and then up to the heart. Once it’s in the heart, it’s on the right side of the heart, it needs to cross over to the left side of the heart. It does require another little puncture. We poke a hole through the atrial septum and we cross the device through the atrial septum to the mitral valve. This is all done mentally invasive, essentially through the groin, and, 90 percent of the device is in the heart, but all our work is outside.

It sounds complicated, but from the patient’s standpoint, is it less complicated?

Biswas: Open heart surgery usually takes about four hours. Afterward, the patient usually goes to the ICU. The patient usually has two chest tubes that may be taken out the first day, but oftentimes require a couple of days before they’re taken out. Then they’re usually in the hospital for about seven days. Our mitral clip usually takes about two hours to do. Sometimes a little bit longer, but a lot of times a little bit shorter. Oftentimes we’re sending the patient home the same day, if not the same day, then oftentimes the next morning. In addition, the recovery period is much less. When people have open heart surgery, we like to send them home, but oftentimes they’re frail and need a lot of help. Most people feel very good, ready to do the things that they need to after a mitral clip.

What does life look like for the patient afterward?

Biswas: Our hope with all patients at this age is to preserve as much quality of life as possible. We understand there are a lot of things causing the shortness of breath. A lot of these people have lots of different conditions, not just a leaky valve. They may have a lot of arthritis, they may have a lot of other chronic conditions, but a lot of these people are living active lives. If we feel this leaky valve is an important contributor to their quality of life, then we feel very good that if we fix this leaky valve, their quality of life will return back to what they wish for themselves.

Do you think it’s a game-changer?

Biswas: It’s a significant game changer. Having this option for people in this age range, it’s very satisfying to see that these people living much fuller lives than they would have years ago.

How would you describe the patient today?

Biswas: They are fantastic. It’s very satisfying to see someone who’s playing golf, going to book clubs, the symphony, and living a full life, whereas he was struggling just to walk across the hall a couple of years ago.

Can you add to this, Dr. Gafoor?

Gafoor: I want to talk a little bit about what structural heart disease is. Many people know the heart is an organ that pumps blood from one part of the body to the other but the same way we have different teachers that teach different subjects in a school, we have different parts of the heart and different doctors that take care of them. For example, the heart is like a house. It has electricity and plumbing. We have doctors that work with electrical systems and doctors that work with the plumbing system, such as heart attacks and blockages in the three arteries that surround the heart muscle. One of the things that structural heart disease does is help with the structures inside the heart. For example, the four heart valves. These valves are like doors; they open and they close. This is great because it allows blood to keep moving in one direction continuously forward, but there are problems that happen when either the valves are too tight or too leaky. With this in place, the majority of people were first not given too many options because some were able to have surgery, and some were able to be treated with medications, but what we realized is that there are a lot of patients that were not getting the care that they needed. Structural heart disease as a field began about 25 years ago when in France, the first doctor was able to come from the leg and go in and put a heart valve inside somebody’s existing heart valve, pushing the old one out to the side. It was a really remarkable time because people did not think this ever could happen but since that day, this technology has grown and spread around the world. With that, we have looked at all four of the heart valves. Swedish has led the way from the beginning for this. We’ve been among the first to take care of people with the aortic valve, which is one of the final valves that leads blood throughout the body. What that does is allow us to do a procedure called a TAVR transcatheter aortic valve replacement. This is where patients were able to get their procedure through the leg under minimal sedation and often go home the same day and back to their full activities within a week or two. We worked together with a large heart team of surgeons and anesthesiologists, and other cardiologists to make sure that we were making the right decision for the patient, but we were able to take care of people in their 80s, and beyond. Some of these people are candidates for open heart surgery and are using this as an option, some of these people are not candidates for open heart surgery. After the field of TAVR started, we started looking at the mitral valve. The mitral valve is one of the most complex valves that are there in the human body. When open-heart surgeons are focusing on the mitral valve, they’re able to repair it or sometimes replace it through open-heart surgery. But many people are not candidates for open heart surgery or some people are just a little bit higher risk for open heart surgery, and it could be because they’re frail. Sometimes it’s because they’ve already had open heart surgery for something else, or they have other organ systems. Swedish was one of the first places in the country to use the mitral clip device. The mitral clip device you may have heard from some of our colleagues what it does, it’s from the leg to go up and put a clip on to help decrease the leakage in the mitral valve. By doing this, we’re able over a period of three hours, to do the procedure, bed rest for four hours, and most patients were able to go home the same day, and they start feeling much better. They get less shortness of breath, less fatigue, less leg swelling, and so on. There were two big trials about this, and Swedish was one of the leaders in these trials. One of them took care of people that had a problem with the valve. It was just not closing well, and so I was doing like this, and so blood was leaking backward. The other one was called the COAP trial where blood was where the valve was just being stretched apart because the chamber beneath it was not allowing you to close well. This showed that not only was a mitral valve that was left untreated, really harmful, but it also showed that 57 percent of patients sometimes may die within the first year if they have mitral valve disease. That’s a big deal. This is a disease process that affects one in 10 Americans over the age of 75. Then after we get the work-up, they may be told they’re not candidates for many therapies, but Swedish has been leading the way. With this procedure done, you are able to get more progress in terms of how long you live and add life to your years. You’re able to walk further, breathe better, and pick up sports again in many people. Mr. Arlington Carter is a great example of that. Because he shows a guy who was really well-known in his job. He’s one of the main engineers at Boeing and for him to have a reduction in quality of life is not easy. His wife had passed away two years before we met him, and he was struggling with the mental, but also now the physical aspect of having this mitral valve disease. By doing this procedure, he was able to feel better, go home soon, go to cardiac rehab, recover, and get back to activities that he enjoys. Cooking, golfing, and going to the Benaroya Symphony Hall. About four years ago where we started off doing 20 to 30 patients a year, then we move to about 60 to 80 patients. In the last year, we had 130 people whom we were able to benefit from treating their mitral and tricuspid valves. We have people in their 50s, that have this procedure done and are able to come back to work. We have people who are in their 90s that are able to spend more time with their families and stay out of nursing homes. This whole philosophy and this approach to care is a revolution called structural heart disease, and you met a few members of our team that have really brought it all together.

In terms of the team, in terms of the three of you, tell me, who does what?

Gafoor: Absolutely. The mitral clip is one of the things that we do. We work about the aortic valve, the tricuspid valve, and in so many different ways to figure out what the best approach for the patient is. If someone comes in and says to their main doctor, ‘I’m having shortness of breath, my legs are swelling, and I’m not feeling good.’ What will happen is, that the doctor will put a stethoscope on, say they’re hearing a murmur, and refer for an echocardiogram, a surface ultrasound to take a look at the heart, and figure out what’s going on. Dr. Biswas, one of my colleagues may read the echocardiogram and talk it over with the patient’s primary doctor, and say that the patient’s having an issue with one of their valves and should see one of us in the clinic. The doctor then makes a referral and then a patient comes and sees us. In the beginning, we’re getting to know patients and figuring out what they’re all about and what’s important to them. Some people say they’re really feeling bad from this and some are not. We got to figure out what’s going to really impact their quality of life. Is it medications, further therapies, or watchful waiting? We just want to know so, how do we do that. That’s where the three of us get together as part of a heart team and work with our open heart surgeons as well as other members of the team to get the right answer. We’ll do a few tests so that our patient may come in just like Mr. Carter will come in to get an angiogram. To go through the wrist, take a look at the arteries, and figure out if there are any blockages that could be contributing to their symptoms. They’ll get a transesophageal echocardiogram, which is a scope that comes back to take a look at the heart in really fine detail. They determine how the valves are doing, how bad they are, whether they can wait, and when they need to go ahead. Sometimes it may get a CAT scan. After that, they’ll meet with Dr. Penetra and me to talk about the benefit of this procedure, what it’s like, what the recovery is like, and what the risks from this procedure are. When that’s all done, we all get together as a team. We meet a few times a week to talk about patients with mitral and tricuspid disease on one day, and aortic disease on a different day, and we go through patients to try to understand what the best approach for them is. Depending on how that goes, some patients will get medical therapy and will just be watched and see how they do, some patients will go to open heart surgery, and many patients will go down the pathway of getting mitral clip therapy.

Can you talk about the procedural process?

Gafoor: During the procedure, a patient is under general anesthesia. An anesthesiologist will be monitoring to make sure that the patient is comfortable all the way through. We also use Dr. Biswas in some of his best capacity and that’s as an imaging specialist. Using a transesophageal echo he takes it, looks at the heart, determines where the leaky valve is, and finds the best place to put the clip, then determines how the anatomy of the valve is working. When that’s in place Dr. Penetra and I will work together to come from the leg through a small keyhole incision just about five millimeters wide. We go in from the femoral vein to go up and put one to three clips in place. Throughout that two to three-hour process, there’s a lot of discussions because we’re able to monitor the heart while the heart is beating and be able to put the clip in place. After that’s done and the clip is in place, before we release it and put it into position, Dr. Biswas determines if the leakage has gone down significantly. This is the right place to put the first clip and then once that’s there, then we deploy the clip and then he evaluates, if we need another one and where we go from there. Once we get the right result, we come out of the procedure room. The patient is able to go to recovery and then afterward we tell patient how they’re doing.

At Swedish hospital, there are way more of these than any other hospital in the country. You guys must be really passionate about it, there must be something. What’s different? Are there other procedures you could do? Why are you so passionate about this?

Gafoor: One of the reasons why we’re so passionate about the whole field of structural heart disease is because it allows patients to have options. It allows people that sometimes have no options to have different options available to help them feel better. All of us went to multiple years of school and did extra training to really focus on this area. When you think about one in 10 Americans has some form of aortic valve disease or 75 percent of people that are over age 65 have mitral, or tricuspid disease. You see this is something that affects a lot of different patients. For us, the reason why we put so much time and effort into this is because we know that this field is growing, this field is adapting and this field is evolving quite quickly. We were there when the mitral clip was just starting. We were there when this was a therapy that we’re still finding a place. As part of being at Swedish, we’re able to not only just taking care of patients, but also from a research perspective that is advancing that therapy significantly. We were able to participate in two of the biggest trials for mitral clip and one of the biggest trials for the tricuspid valve that really help advance this field forward. In addition to that, we have a fellowship program and by giving national presentations and publications, we’ve trained physicians all around the country for this therapy. Most importantly, what really has made the difference to allow us to be so successful is really the whole team. It’s not just physicians that are doing the work. There are nurses, nurse practitioners, patient care coordinators, and schedulers who all work together to make this a priority. Our referring cardiologists and our patients see that and they feel that, and they trust us to make the right decision for them at the right time. We turn away patients as well because we feel that not everybody would benefit from this therapy but we want to know when we do this that we make the biggest difference. In the field of mitral and tricuspid disease, experience matters. We know that by doing a significant portion of these, we’re able to get the best outcomes and that helps us a lot.

Do you have patients come from all over the country because you guys are the leaders?

Gafoor: Yeah, this is one of the things that we really focus on. It’s been good, but people do come from pretty far away for this sort of stuff.

You were saying that some patients don’t qualify?

Gafoor: We know with the mitral valve comes in many shapes and sizes. What the mitral clip does is that it makes the leaflets come together so that the valve leaks less. Which is great. I remember when I said earlier that valves have two problems. They can either be too leaky, or they can be too tight. One of the things we really worry about is when we sometimes put the clip in, whether the valve will be too tight to handle that. That’s where Dr. Biswas, Dr. Penetra, and I spend a lot of time with the prior studies, the prior imaging, and the workup to determine how big of a valve are we starting with and if it will accommodate the clips that we need to be able to get the result that we want. That’s one issue. Sometimes people have already had surgery, or they’ve had other things that make their heart really difficult to visualize under the scopes that we try to do. If you can’t see where do you go from there? There are other options such as being able to put in a whole new mitral valve, or a whole new tricuspid valve to help take care of these patients. Those are being studied as part of research trials in Swedish is one of the places to get that done. Mitral clip is one way of taking care of the mitral valve, a valve replacement is another. This helps by being able to bridge both options. We’re able to take care of a lot of patients. There are some patients that don’t meet those criteria but we’re looking for

Can you demonstrate, Dr. Panaich?

Panaiach: This is a MitraClip device. This is one of the percutaneous devices that we use to fix patients with leaky heart valves, specifically the mitral valve, which is a left-sided heart valve when patients with severe leakage of the mitral valve- patients who have severe leakage of the mitral valve will have shortness of breath. They’ll have a poor quality of life. This is one of the devices that can be used instead of surgery. It’s a percutaneous device that we insert through the patient’s groin, through the femoral venous access. This leads all the way to the patient’s heart. We use all these complex maneuvers or knobs to control the device from the patient’s groin inside the patient’s heart and we repair the patient’s valve standing from the groin. This is what the MitraClip device looks like. When the device goes in, it clips the patient’s leaflets. Once they are clipped, they look like this. This is the patient’s two leaflets clipped together so that the leakage doesn’t go back, but there’s still blood that can flow alongside these leaflets down.

END OF INTERVIEW

This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.

If you would like more information, please contact:

Mafara L. Hobson

Mafara.hobson@swedish.org

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