Siddharth Wayangankar, M.D., interventional cardiologist, with expertise in structural heart disease, talks about a new mitral valve procedure that is helping save hearts.
Interview conducted by Ivanhoe Broadcast News in November 2021.
Now tell me what a mitral valve is and does.
DR WAYANGANKAR: The mitral valve is located between the two heart chambers on the left side of the heart known as the left atrium and the left ventricle. The mitral valve helps control the blood flow between these two chambers. As you know, all valves are uni-directional, meaning it flows in one direction. The problems start if the valve doesn’t work and starts working bi-directional, or two ways, or the flow is limited when the valve is narrowed, which is “stenosis” in medical terminology.
So, what happens when the mitral valve starts wearing out?
DR WAYANGANKAR: If there are any problem with the dynamics of this flow, you’re going to have pressure changes within each chamber of the heart that then start to impact the lungs; therefore, the most common symptom that patients have is shortness of breath, especially with exertion.
Can it lead to more severe problems?
DR WAYANGANKAR: It really depends on the pathology of the mitral valve. The other thing that can happen is there are permanent changes in the dimensions of the heart chambers. The chambers may dilate and lead to problems like electrical problems, such as atrial fibrillation. It’s usually a chronic process. As you said, there could be more severe conditions if the changes happen acutely or suddenly.
Is there something that causes it?
DR WAYANGANKAR: Usually, these are degenerative in nature. There are some mitral valve conditions that may have infective or auto-immune origin where we have a condition called rheumatic heart disease. More commonly, there can be changes to the mitral valve called rheumatic mitral valve disease. Otherwise, most of these conditions are degenerative as we age. In certain conditions and certain patients, it could be congenital issues with the architecture of the tissue of the mitral valve. Again, these are very rare.
Now in the past, it was a pretty big procedure to fix this.
DR WAYANGANKAR: Yes. Even now, I would say that if you are a good surgical candidate, and you have a degenerative mitral valve, the standard of care is open heart surgery for replacing or repairing the valve. When you “replace” the valve, you replace it with a bioprosthetic/mechanical valve. When you surgically “repair” the valve, you put in a ring. And that holds the valve together.
That comes with a lot of risk anytime you do open heart surgery.
DR WAYANGANKAR: Open heart surgery always comes with risk. When these valves, which usually last 10 to 15 years, fail, then the second open heart surgery can be risky. As the patient gets older, the co-morbidities, or other underlying illnesses, become bigger. Opening the chest, the second time is a bigger risk that physicians and the patients have to take. This new procedure (Transcatheter Mitral Valve in Ring – TMVIR) helps prevent a second open-heart surgery, while still addressing their problem.
Is there a percentage of risk? Do you know that?
DR WAYANGANKAR: It’s case-by-case. There are a lot of criteria that surgeons and physicians like us follow. There is a risk score called STS, which is a Society of Thoracic Surgeons calculation of risk, and there are several other risk scoring criteria. Despite these scoring algorithms, every patient is different and there are multiple variables that affect the risk of a second open-heart surgery.
So before, what would be your option for someone who you know is older and not in great health and needs a replacement?
DR WAYANGANKAR: The options were extremely limited; medical therapy to help them with symptoms, water pills here and there, some blood pressure medications. But, when there’s a mechanical problem, you can only manage it in a limited fashion. I call it the Band-Aid treatment. You need something definitive like a second time valve replacement to fix it.
This TMVIR is giving you that?
DR WAYANGANKAR: That’s right. There are a lot of companies working very hard to make a dedicated mitral valve worthy of transcatheter replacement. There are multiple of them in the trials, but none in the market right now. The innovative fact about this procedure is that we have used a technology that’s tried and tested in the aortic position. We take the same aortic valve (used in TMVIR procedures) and we reverse it. We go from the right side of the heart to the left side, all transcatheter, all minimally invasive through the groin of the patient, and then we go from the right side to the left side and deploy the valve in the mitral position across the ring or across the failing bioprosthetic valve. The valve starts working immediately. Most of these patients feel great the next day and are able to go home the next day.
So, are there a lot of risks to this?
DR WAYANGANKAR: There are risks with all procedures – especially something that is new or out of the box. However, these are extensively discussed with patients, and of more importance, we at Baptist health discuss the risk benefit ratio of each procedure (customized to each patient) within a multi-specialty collaborative forum – the Valve conference. This exercise helps develop a consensus regarding the best way to manage a patient by formulating strategies to ameliorate expected risks.
What are the three biggest risks?
DR WAYANGANKAR: Well, if you specifically speak about mitral valve injury, depending upon the anatomy of the patient, there’s the risk of the valve either moving up or down and embolizing. There’s the risk of the valve obstructing other chambers of the heart. It may also change the orientation of the original leaflets of the patient’s valve. Remember, when the surgeon puts the ring in, the native leaflets are still there. So, when you put a new valve across it, it may push the original leaflets and obstruct flow outside the heart. The multi-specialty valve conference reviews CT scans of each patient to understand potential risks and develops strategies to ameliorate expected risks. Whenever I take up a high-risk procedure, I always have a Plan B and a Plan C!
So how does that affect the patient?
DR WAYANGANKAR: It could lead to a dramatic drop in blood pressure, or an inability to breathe. We have to do certain advanced maneuvers to relieve that obstruction.
The open heart is how many hours in surgery, the TMVIR is how many?
DR WAYANGANKAR: A re-do open heart mitral valve surgery from anesthesia to closure may take at least two to three hours. This [TMVIR] procedure was done in about 45 minutes.
What is the recovery time for open heart?
DR WAYANGANKAR: By the time the patient goes home for the first time, it’s at least three to five days. For a re-do open heart, I think it would be at least seven days. Our patient [who received TMVIR]was discharged the next day.
Then what is recovery time at home for open heart?
DR WAYANGANKAR: That could be prolonged. The rehabilitation procedure after an open-heart surgery can last weeks, and I’ve seen patients taking up to three to four months to come back to peak performance. With the minimally invasive procedures, we see some of the patients back to peak performance in a couple of weeks.
Were you even surprised about how fast?
DR WAYANGANKAR: Absolutely. I was actually very, very pleased as to how nice the procedure went and more surprised as to how the patient responded. He’s doing fantastic. I couldn’t be happier for him. I told him, ‘This is your Christmas and New Year’s gifts all together’.
There you go. You’re talking about Mr. Bowler?
DR WAYANGANKAR: That’s right.
What was he like when you first saw him?
DR WAYANGANKAR: Mr. Bowler was extremely incapacitated. He could barely walk ten feet. He would get short of breath. He had completely lost hope. He lost the will to live, and it was very depressing to see that. A time comes when patients go to multiple physicians, surgeons and cardiologists. When they see limited options, or options that are nonexistent, it does depress you mentally more than the physical limitations. I could see both physical and mental limitations in that patient. I felt that he was losing hope in life, but I told him about this new procedure. It just got FDA approval and we would be willing to offer it. I was very honest with him. I told him this would be the first procedure in the state of Florida after FDA’s approval. I told him all the risks. I’m glad he took it and I’m glad I was willing to take the risks. I’m very happy that our team supported me.
What did you see when you got the scans from Mr. Bowler?
DR WAYANGANKAR: So, there were two or three concerning things about the scan. One of them was this is a new procedure. There are no fixed algorithms. We had to make phone calls with the experts, and we talked about what could be the sizing of the valve. The algorithms had a different sizing, but we felt that was too small, so we actually increased the size. We basically felt that there were the conditions that I talked about. You have the native leaflets because he had a prior mitral valve ring. He had his original leaflet still left after the last procedure. One of them was very long, and I was worried that when I put the new valve in, it would obstruct the left ventricular outflow tract, which could then lead to hemodynamic compromise, and the blood pressure may drop. He may not tolerate it at all. So, we had to be ready to do those advanced procedures to relieve this problem. So, I was mainly worried about these two things with him. Again, there’s always this risk of the valve embolizing because it’s just a ring holding on to the new valve. You are worried the valve may go up or down. It has to land perfectly. It cannot land any less down, any less up, because all the complications that we just talked about can happen. So, precision was extremely important. Normally, when we do transcatheter procedures, we have our surgeon with us who, if something goes wrong, opens up the chest and tries to save the patient. Mr. Bowler had already had two or three open heart surgeries. He was deemed prohibitive risk for surgery by two or three cardiac surgeons from different institutions. When I say prohibitive, that means there is no way anybody is going to open the chest if something goes wrong. So, it almost felt like a one-way street going in and I was very honest with Mr. Bowler. I told him that this is a very high-risk procedure, even when done transcatheter, because not many people have done it. We are trying to attempt something that has been done very few times in the country. He took the chances. We had excellent planning, and I think that is where we are at Baptist. We are a great group of collaborative physicians. Remember, this is just not my procedure. This is a procedure involving me, as an interventional cardiologist; the cardiac surgeon, Dr. Bates; the imaging expert, Dr. Kanaparti, who did the CT imaging and helped in the preplanning; Dr. Zamora, who did the intraprocedural planning; and Dr. Satpathy, who also contributed to the pre-procedural strategy
It takes a village.
DR WAYANGANKAR: It takes a village, right. You also need to give credit to the referring cardiologist, Dr. Rama, who actually recognized it in the first place. So, we all sit together. We plan these procedures. It takes 45 minutes to do the procedure. What people don’t realize, it took me and the team about 16 to 20 hours to sit down with all these multispecialty people, pre-procedural planning, intra-procedural planning and post-procedural planning. I’m glad to say that it was executed to perfection. I don’t think this could have gone more perfectly.
Without this, what would have Mr. Bowler’s chances be?
DR WAYANGANKAR: Honestly, he was already having an extremely poor quality of life. More than that, I was worried about his survival. I would say that his survival would have been limited.
So, do you see this moving on from extreme can’t-open-the-chest patients to everybody who might need this?
DR WAYANGANKAR: As it stands right now, open-heart surgery with mitral valve replacement is the first choice of therapy for anybody who is eligible for the surgery. Patients who are deemed high risk for a second open-heart surgery are eligible for this procedure, whether they had a previous mitral valve or whether they had a previous mitral ring. If they are deemed high risk for open-heart surgery, we would be happy to help them and serve them with this procedure.
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.
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