Mitral Valve Awareness: Transcatheter Mitral Valve Repair & Replacement Innovations
Written By: Adam Pick, Patient Advocate, Author & Website Founder
Medical Expert: Howard Herrmann, MD, Director for Interventional Cardiology, Penn Medicine
Published: April 13, 2023
Earlier in Mitral Valve Disease Awareness Week, we shared the “Top 5 Considerations for Mitral Valve Surgery Patients” which addressed the use of new transcatheter mitral valve therapies for non-invasive mitral valve repair and mitral valve replacement operations. These mitral valve therapies require no incision to the patient’s chest and no use of the heart-lung machine.
To learn more about these next-generation therapies for the treatment of mitral valve disease, we interviewed Dr. Howard Herrmann, a leading interventional cardiologist from Penn Medicine in Philadelphia, Pennsylvania.
Important Findings About Transcatheter Mitral Valve Therapy
Here are important findings shared by Dr. Herrmann about transcatheter mitral valve therapy:
- The use of catheters to treat heart valve disease has evolved during the past 40 years. Initially, interventional cardiologists used catheters to “open-up” stuck aortic and mitral valves using balloon technologies. The results from balloon valvuloplasty provided patients some improvement.
- The MitraClip provided physicians a new device to treat mitral regurgitation, a leaky heart valve, that emulated a surgical procedure.
- Similar to other transcatheter procedures (e.g. transcatheter aortic valve replacement), the MitraClip does not require an incision to the patient’s chest (or ribs), the patient does not need to be on a heart-lung machine, and the patient does not always need to have general anesthesia.
- The MitraClip received FDA approval in 2013 for select patients that were classified as “high risk” patients with primary regurgitation.
- There are two types of mitral regurgitation – primary and secondary mitral regurgitation. “There are really two kinds of mitral regurgitation. Primary regurgitation refers to diseases that affect the leaflets, things like mitral valve prolapse,” states Dr. Herrmann. “Secondary mitral regurgitation refers to the diseases that affect the ventricle where the mitral leaflets attach. If you had a heart attack or a cardiomyopathy and your left ventricle isn’t large, it pulls on those leaflets, separates them and makes it harder for the leaflets to get together and block a regurgitant flow.”
- In 2019, the MitraClip received FDA approval for the treatment of secondary mitral regurgitation following the COAPT Clinical Trial.
- Clip technologies for the treatment of mitral regurgitation continue to improve. “We’re getting better and better at doing this,” states Dr. Herrmann. “There are new trials looking at lower-risk patients to see if we can duplicate the results that we saw in high-risk patients.”
- Innovation and investment specific to transcatheter mitral valve therapy is happening at a rapid pace. Dr. Herrmann states, “There are a number of devices, probably 30-some companies now developing various forms of catheter-based valve replacements. These are foldable devices, compressible devices, balloon expandable devices, and self-expanding devices.”
- Dr. Herrmann’s number one piece of advice for patients is to be at a cardiac center that specializes in mitral valve therapy. “The most important thing is to be at a center that has all of the options,” states Dr. Herrmann. “There are just as many incredible advances happening in the surgical field, robotic surgery and minimally invasive techniques. Each patient is different. You want to have the options all available to you and make an informed choice.”
Keep Learning About Mitral Valve Disease
As part of Mitral Valve Disease Awareness Week, we’re sharing new information to educate you about the management and the treatment of mitral valve disease including:
- Surgeon Q&A: Recovery from Mitral Valve Surgery
- Medical Insights: Complex Mitral Valve Therapy
- The Future of Mitral Valve Therapy
Keep on tickin!
Adam
P.S. For the deaf and hard of hearing, I have provided a written transcript of the video with Dr. Herrmann below:
Adam Pick: Hi, everybody, it’s Adam with HeartValveSurgery.com. This is a special cardiologist question and answer session all about transcatheter mitral valve therapy. I am thrilled to be joined by Doctor Howard Herrmann who’s the director for interventional cardiology at Penn Medicine in Philadelphia, Pennsylvania. During his extraordinary career, Dr. Herrmann has been performing transcatheter mitral valve therapies for over 20 years. Dr. Herrmann, it is great to see you again. Thanks so much for being with us today.
Dr. Herrmann: Thank you, Adam. It’s a pleasure to be here with you as well.
Adam Pick: Dr. Herrmann, to get started, can you help the patients out there understand what is an interventional cardiologist?
Dr. Herrmann: Interventional cardiologist like myself is someone who does procedures in the heart. Some of those are diagnostic procedures, cardiac catheterizations to figure out what’s wrong, either in the arteries or the chambers of the heart, and therapeutic procedures where we fix things. When I started my career, that involved primarily balloon angioplasty. Overtime, that’s evolved to stenting, peripheral vascular procedures and the area of my main interest, which is structural and valvular heart disease. Now we’re able to repair and replace heart valves.
Adam Pick: Dr. Herrmann, that is fascinating. Can you talk about the evolution of how you’re using catheters to treat valvular disease and perhaps, what are some of the benefits for patients?
Dr. Herrmann: The field of using catheters to fix heart disease and particularly valve disease really began in the 1980s with the use of large balloons to open up stuck valves in the pulmonic, mitral and eventually, the aortic position. This was blowing up a balloon placed through a catheter in the groin. We didn’t have to do open heart surgery. We didn’t have to stop the heart. In fact, most of the time the patients were awake under some form of conscious sedation. The recovery was very quick.
We could blow up these balloons, split open the valves and get some improvement for their symptoms. That was where we were in the 1980s. Aortic balloon valvuloplasty turned out to be not such a great procedure, had somebenefit. The field was dormant for a while until the development of things like MitraClip, which allowed us to start treating regurgitant or leaky heart valves, not stuck ones. That began in the early 2000 period and has led the revolution to transcatheter valve replacement where we actually put in an aortic mitral or pulmonic valve, and even tricuspid valves now. All of the valves we can now replace through a catheter in the groin.
Adam Pick: Let’s dive a little deeper into the MitraClip, which is, as I understand, one of the first transcatheter mitral valve therapies to receive approval. When did it get a FTA indication and what has been the result for your patients?
Dr. Herrmann: MitraClip is a procedure where we put a clip on the two leaflets in the middle to create a dual orifice. Normally the mitral valve opens and closes. Here, we’re putting a clip in the middle so that we end up with two openings. The first ones of those procedures were done more than 20 years ago, in 2003. The majority of those procedures are done through the femoral vein, threaded then up through the veins of the system into the heart. Sometimes we have to make a little hole in the heart chambers to get from one side to the other.
The point is that we don’t have to stop the heart. There’s no heart-lung bypass machine involved. There’s no incision that has to heal. There’s no dilution of the blood. The only thing the patient really knows about is the general anesthesia. They are put to sleep for these procedures. The procedures take anywhere from an hour and a half to two or three hours depending on how complicated the procedure is and how much work has to be done. The great majority of patients can go home the next day.
The approval in 2013 demonstrated that this procedure was safer than surgery and the results were good enough for high-risk patients. That was the approval in 2013 for what’s called primary mitral regurgitation.
Adam Pick: Dr. Herrmann, you just talked about primary regurgitation being treated with the MitraClip. I’m curious if you can distinguish what secondary mitral regurgitation is and what’s being done to help patients maybe using transcatheter techniques.
Dr. Herrmann: As you alluded to, there are really two kinds of mitral regurgitation. Primary regurgitation refer to diseases that affect the leaflets, things like mitral valve prolapse. Secondary mitral regurgitation refers to the diseases that affect the ventricle where the mitral leaflets attach. If you had a heart attack or a cardiomyopathy and your left ventricle isn’t large, it pulls on those leaflets, separates them and makes it harder for them to get together and block a regurgitant flow.
In 2019, an important trial was published called COAPT that demonstrated that patients who had secondary mitral regurgitation also benefited from the MitraClip with less mortality and fewer heart failure hospitalizations over subsequent years. Importantly, Adam, we’ve gotten better and better at doing MitraClip. It’s now called T.E.E.R. T.E.E.R. stands for Transcatheter Edge-to-Edge Repair, T-E-E-R. Over the last 10 years, we’ve gotten bigger clips, longer clips, different kinds of clips. We’re getting better and better at doing this. There are new trials looking at lower-risk patients to see if we can duplicate the results that we saw in the high-risk patients.
Adam Pick: Dr. Herrmann, great progress for primary and secondary mitral regurgitation. As you know, some patients may not have a valve that’s repairable. I’m curious to know, are you working on anything for transcatheter mitral valve replacement?
Dr. Herrmann: Yeah, that’s a great question, Adam. As you’re alluding to, probably only a third of patients are perfect candidates for this transcatheter edge-to-edge repair. There are others than can be treated, but maybe their results won’t be quite as good as in those perfect candidates. Then there’s some patients who just can’t be treated with edge-to-edge repair. They have calcified valves. Their leak is too extensive to clip closed. For those patients, a valve replacement is really the best option. There are a number of devices, probably 30-some companies now developing various forms of catheter-based valve replacements. These are foldable devices, compressible devices, balloon expandable devices, self-expanding devices.
Adam Pick: Dr. Herrmann, given your incredible experience with transcatheter mitral valve techniques, what is your number one piece of advice for patients considering these procedures?
Dr. Herrmann: The most important thing is to be at a center that has all of the options. There are just as many incredible advances happening in the surgical field, robotic surgery and minimally invasive techniques. Each patient’s different. You want to have the options all available to you and make an informed choice, not only on your own but with your physicians about what’s best for your specific mitral valve problem.
Adam Pick: That is great advice, Dr. Herrmann. On behalf of all the patients at HeartValveSurgery.com, patients all over the world, I want to thank you for taking time away from your very busy practice at Penn Medicine and sharing all these great insights about innovations for transcatheter mitral valve therapy.
Dr. Herrmann: Well, thank you very much, Adam. I’m always happy to educate your viewers and your patients.
Written by Adam Pick
- Patient & Website Founder
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