MitraClip Q&A: Exercise, Availability & Clinical Trials with Dr. Arman Arghami

Written By: Adam Pick, Patient Advocate, Author & Website Founder

Medical Expert: Arman Arghami, MD, Mayo Clinic

Published: November 29, 2022

We just received questions from Nancy and Kevin about MitraClip durability and availability. In her email, Nancy asks, “Hi Adam. I had a mitral valve repair with a ring two years ago. The valve is now leaking again. My doctor wants me to see a surgeon about getting the MitraClip. My question is… I am very athletic. I ski. I hike. Do I need to be concerned about the MitraClip tearing the leaflets when I work out?” In a separate email, Kevin asked, “Is it true the MitraClip is available for all patients?”

To provide Nancy and Kevin an expert response, we connected with Dr. Arman Arghami, a mitral valve surgeon at the Mayo Clinic in Rochester, Minnesota. During our interview, Dr. Arghami shared several important insights about the MitraClip, how it transforms mitral valve functionality, and clinical trials that are evaluating its safety-and-effectiveness in lower-risk patients.

 

 

Key Learnings About the MitraClip from Dr. Arghami

Here are several important learnings from Dr. Arghami:

  • The MitraClip is a non-invasive form of mitral valve repair that uses catheters to “clip” the leaflets of the mitral valve to minimize mitral regurgitation.  The MitraClip does not require an incision to the patient’s chest or ribs and MitraClip patients do not need to be on the heart lung machine.
  • Typically, the MitraClip does not typically tear the mitral leaflets after implantation. “If we allow the clip to heal completely, they usually don’t tear afterwards,” states Dr. Arghami.  “Because the body creates a strong tissue, a healing tissue that keeps these clips in place.”
  • Dr. Arghami suggests that the MitraClip creates a non-anatomical valve that does not open-and-close like a normal mitral valve. “The MitraClip creates what we call a ‘non-anatomical valve’. Basically, the valve does not open-and-close the normal way anymore, because the middle part is pinched. It only opens on the sides.”

 

MitraClip Non-Anatomical ValveMitraClip Implantation

 

  • Not all patients are candidates for the MitraClip. Currently, the MitraClip is FDA-approved for higher-risk patients.
  • Considering that Nancy is a re-operative mitral valve patient the previously received an annuloplasty ring, there are additional concerns for Nancy including the size of the valve opening which may create stenosis if a MitraClip is implanted, according to Dr. Arghami.

 

REPAIR MR Clinical Trial

 

  • Clinical trials are now evaluating the safety-and-effectiveness in lower risk patients. “Currently, there are trials going on, the most famous one being REPAIR MR,” states Dr. Arghami.  “REPAIR MR is recruiting patients who are moderate risk for surgery and trying to compare whether a MitraClip could be equal to open surgery.”

 

Many Thanks to Dr. Arghami & Mayo Clinic!

On behalf of our patient community, many thanks to Dr. Arman Arghami for taking the time to share his clinical research and experience with us.  In addition, we would like to thank the entire Mayo Clinic teams in Minnesota, Arizona and Florida for taking such great care of the patients from HeartValveSurgery.com.

Keep on tickin!
Adam

P.S. For the hearing impaired members of our community, I have provided a written transcript of our interview with Dr. Arghami below.

Written by Adam Pick
- Patient & Website Founder

Adam Pick, Heart Valve Patient Advocate

Adam Pick is a heart valve patient and author of The Patient's Guide To Heart Valve Surgery. In 2006, Adam founded HeartValveSurgery.com to educate and empower patients. This award-winning website has helped over 10 million people fight heart valve disease. Adam has been featured by the American Heart Association and Medical News Today.

Adam Pick is a heart valve patient and author of The Patient's Guide To Heart Valve Surgery. In 2006, Adam founded HeartValveSurgery.com to educate and empower patients. This award-winning website has helped over 10 million people fight heart valve disease. Adam has been featured by the American Heart Association and Medical News Today.

Video Transcript:

Adam Pick: Hi, everybody. It’s Adam with heartvalvesurgery.com, and today we’re answering your questions all about the MitraClip. I am thrilled to be joined by Dr. Arman Arghami, who’s a leading mitral valve surgeon at Mayo Clinic in Rochester, Minnesota. During his extraordinary career, Dr. Arghami has performed over a thousand heart valve repair and heart valve replacement procedures. Dr. Arghami, it is great to see you again. Thanks for being with us today.

Dr. Arman Arghami: Hi, Adam. Thanks for having me. It’s great to be with you and the heartvalvesurgery.com community.

Adam: Dr. Arghami, we have not one, but two questions all about your specialty with mitral valve reconstruction, repair, and replacement. This one is all about the MitraClip. We’re starting with Nancy’s question. She asks, “Hi Adam. I had a mitral valve repair with a ring two years ago. The valve is now leaking again. My doctor wants me to see a surgeon about getting the MitraClip. My question is – I am very athletic. I ski. I hike. Do I need to be concerned about the MitraClip tearing the leaflets when I work out?”

Dr. Arman Arghami: Very good question, Adam. I want to explain this a little bit for those of your audience who are not very familiar with the MitraClip. MitraClip is actually a very tiny, small clip that is usually placed in the heart without an open heart surgery, usually through a vein from the groin. It goes and basically pinches the two sides of the mitral valve together. This reduces the amount of leakage, but it creates what we call a non-anatomical valve. Basically, the valve doesn’t open and close the normal way anymore, because the middle part it pinched. It only opens on the sides.

Now, two answers to Nancy – one, if we allow the clip to heal completely, they usually don’t tear afterwards, because the body creates a strong tissue, a healing tissue that keeps these clips in place. The more important answer I have for Nancy is that because this repair with the clip is non-anatomical, it’s – first of all, this was designed only for patients who are not a surgical candidate. They’re very high risk for surgery. We have nothing else to offer except for a clip. It will reduce the amount of leakage in a non-anatomical fashion.

Now, for her it’s also important because she’s telling me that she has an active lifestyle. That makes a difference. Because the valve is now pinched in the middle, by nature it’s a smaller orifice. When you exercise, your body pumps a lot of blood through. You need a big opening to allow all this blood to go through without any hindrance to the flow, because she had a repair before. That in nature also reduces the valve size a little bit. Now you’re putting a clip on top of that. I would be worried that this, with her active lifestyle, may create some stenosis or resistance for the flow of blood to go through. That might be actually not a good thing for her. For her, I think a good echocardiogram and evaluation by a surgeon and cardiologist and consideration for a re-repair or even a replacement should be given. Also, if none of those are a good option, then a clip may be a good option for her.

Adam: Nancy, I hope that helped you. I know it helped me. Moving on to our next question, Dr. Arghami – this one comes in from Kevin. He asks, “Adam, I have been told that the MitraClip is now available for all patients with mitral regurgitation. Is that true?”

Dr. Arman Arghami: Thanks, Kevin, for asking that question. That’s actually a fairly common question to get around here too. As I said to Nancy’s answer, the MitraClip is approved for very high-risk patients who cannot tolerate open heart surgery. Now, currently there are trials going on, the most famous one being REPAIR MR for the acronym. That is recruiting patients who are moderate risk for surgery and trying to compare whether a MitraClip could be equal to open surgery. I’m not aware of any commercially available FD-approved procedures for low-risk patients, and for good reasons.

Adam: Dr. Arghami, with the REPAIR MR trial, it sounds like similar to TAVR, there are various points in the evolution of the device and the research to understand its applicability to different patient types. Is that correct?

Dr. Arman Arghami: That is absolutely right, Adam. Remember, there’s a slight difference. With the TAVR, you are replacing the valve with a valve that has been designed very similar to a surgical valve. Again, remember, in this MitraClip trial, the repair is completely different. It’s not even anatomic. It doesn’t look like a normal valve. We want to know what the answer is, whether this is also a suitable option for everybody or not. I guess we’ll find out soon.

Adam: Dr. Arghami, very helpful insights for me and for the entire community at heartvalvesurgery.com. On behalf of our patients, I want to thank you for taking time away from your very busy practice there at Mayo Clinic in Rochester, Minnesota and being with us today. Thanks for being here.

Dr. Arman Arghami: Thanks, Adam. It’s a pleasure to be with you and your audience. I wish you the best.