Talking Tall Rounds®: Mitral Valve Disease

Podcast Transcript

Announcer:

Welcome to the Talking Tall Rounds series, brought to you by the Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute at Cleveland Clinic.

Brian Griffin, MD:

Good morning, everybody. I have great pleasure in introducing the inaugural F. Gene Braun and Ellen Braun lecture in mitral valve disease. We're very honored today to have Ellen Braun here. Dr. Gene Braun was a patient of mine who had mitral valve disease and we were very honored to be able to impact his care here with surgery. When Gene passed a number of years ago, we had discussions with Ellen about how we would honor his memory. Gene was an ophthalmologist, very innovative, incredibly effective ophthalmologist in Dallas, and Ellen wanted something medical in his memory. We've come up with a number of ideas, one of which is this inaugural lecture.

Brian Griffin, MD:

Ellen and Gene's estate have very kindly honored his memory by providing funding for a fellow in cardiovascular imaging. I'm delighted to say we have Chris Anthony, who's the inaugural Ellen and Gene Braun fellow, who's going to present today.

Chris Anthony, MBBS, PhD, FRACP:

It's a privilege to present a clinical case that the F. Gene Braun Tall Rounds this morning. The clinical case is entitled, Does a stitch or a clip in time save nine? The goal of this presentation is to set the scene for the ensuing discussion on advanced technologies and the multidisciplinary approach to mitral valve disease. I present a case of a 72 year old female with increasing shortness of breath on exertion and a decline in functional capacity over a period of four months. Her shortness of breath was associated with exertional chest discomfort and these symptoms prompted a presentation to her local emergency department and a review by her local cardiologist.

Chris Anthony, MBBS, PhD, FRACP:

Her past medical history was remarkable for heart failure with preserved ejection fraction, atrial fibrillation, hypertension, hypothyroidism, and heterotaxy syndrome with polysplenia. Her medications were digoxin, diltiazem, and apixaban for her atrial fibrillation. She was euthyroid on her daily dose of thyroxine, and she was compliant with all her medications. Biochemical parameters were normal across the board with preserve hematopoietic renal and liver function. Her EKG was remarkable for atrial fibrillation with control ventricular response, normal cardiac access with no significant SD segment or T wave changes.

Chris Anthony, MBBS, PhD, FRACP:

A transthoracic echocardiogram was performed and a parasternal long-axis image on the left demonstrates prolapse of the posterior leaflet and a severely dilated left atrium. On the right, you'll see an apical four chamber view demonstrating the posterior leaflet prolapse with normal biventricular size and function. On color Doppler interrogation of a mitral valve, what you'll appreciate with the large stream of color flowing across the atrium is a large eccentric wrap around regurgitant jet suggestive of significant mitral regurgitation. To better quantify the severe of mitral regurgitation, we used qualitative and quantitative methods to assess severity.

Chris Anthony, MBBS, PhD, FRACP:

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This was severe mitral regurgitation across the board with a high vena contracta, effective regurgitant orifice area, and significant regurgitant volumes and fraction. Her PAMI artery systolic pressure, which is the measure of her right-sided pressures, was also elevated and was averaged out to at least 60 millimeters of mercury plus the right atrial pressure. This is in keeping with severely elevated right heart pressure and is an additional sign of severe mitral regurgitation and portends a poor prognosis with regards to severe mitral regurgitation. A 3D reconstruction on transthoracic echocardiogram actually demonstrated the clear pathology in the situation, which was a flail P2 segment in addition to her primary degenerative prolapse.

Chris Anthony, MBBS, PhD, FRACP:

Cardiac catheterization was also performed as part of her workup and it demonstrated a 30% luminal stenosis in the mid segment of her left anterior descending artery with no significant stenosis in a circumflex system or her right coronary artery systems. In summary, this is a 72 year old female with severe degenerative mitral regurgitation preserved by ventricular function, elevated pulmonary pressures, and NYHA Class 2-3 symptoms. She was referred to the Cleveland Clinic for formal evaluation by the structural heart team where multidisciplinary based approach to the assessment of suitability for surgical mitral valve repair versus percutaneous mitral valve repair was then undertaken. Thank you very much.

Amar Krishnaswamy, MD:

Dr. Griffin, thanks so much for the very kind introduction. Ellen, thanks so much for the opportunity to have this lecture series. So what I'd like to do is go through sort of a case based atlas of percutaneous mitral therapies over the next few minutes, talking about edge-to-edge leaflet repair, percutaneous annuloplasty and native valve replacement, as well as the replacement of degenerated surgical valves and treatment of paravalvular regurgitation, just really to understand what is a portfolio of therapies that we can provide to patients with catheter-based treatments.

Amar Krishnaswamy, MD:

So we look at edge-to-edge repair. Certainly the MitraClip is something we have done for a long time, but I'd like to demonstrate how in the contemporary era it is frankly better. This is a 77 year old with a prior mechanical valve replacement. You can see here in the 3D multiplanar reconstruction that Rhonda pointed to earlier, this flail in the 3D imaging of the anterior leaflet and sort of this retracted posterior leaflet, which is much more nicely seen in the long-axis imaging plane here. Now, this is important not only for the diagnostic portion, but also the therapeutic portion of this patient's care. You can see here in this initial grasp of the mitral valve, if you look very closely, what you see is we've come just a bit medially to this posterior leaflet that's retracted.

Amar Krishnaswamy, MD:

Now, as a result, we have, I think, a good result of the MitraClip, but there is some residual leak left here in that area where the posterior leaflet hasn't been grabbed. I'll be quite honest, a few years ago, we would've left this at as an excellent MitraClip result because we wouldn't have seen what we couldn't see. But in the current era, we have a much more granular understanding of what we're doing. And also with this current generation of the clip that I'll point out, what we can do is simply clockwise the clip a little bit, really let go of the anterior leaflet, grasp only the posterior leaflet, we don't have to grasp both of them together, get that retracted posterior leaflet there, swing back around, get the anterior leaflet.

Amar Krishnaswamy, MD:

And what you see now is really no residual mitral valve regurgitation and a much more surgical like result as Dan and Dr. Gillinov have pointed out. Really this is in large part due to the contemporary advances of the MitraClip. Instead of just the one clip that we had previously, we now have four different ones that are wider and longer. We can also grasp the leaflets independently, which is a new technology as I showed to you in this case. And again, just as importantly, the imaging that we have now in the operating room is really far better than what we had a few years ago and allows us to do these cases and ones that are frankly more complex. The contemporary clip results are far better than what we had seen in the earlier trials.

Amar Krishnaswamy, MD:

What this shows you is that this early generation clip in this new series was used less than 20% of the time in both primary and secondary MR cases. And what you see is that out at one month, more than 93% of patients have one plus or less MR with a very low degree of risk in what are otherwise considered patients at high or extreme risk for cardiac surgery.

Amar Krishnaswamy, MD:

Moving on to other potential therapies, this is a 67-year-old gentleman with significant LV dysfunction. And you can see on the 3D NPR, very wide area of leaking across the coaptation here, also seen in the commissural view up to the right. We know in coapt that the MitraClip does provide benefit in functional MR patients. We should treat these patients both with regard to hospitalizations for heart failure on the left and mortal on the right. However, we also know that patients treated with a MitraClip who are left with the residual MR don't do as well in red and blue as those patients who did well in green. What are other therapies that we have? This is the Carillon device. This is a band, as you see here. This is a coronary sinus venogram. And what we do is we place this band in the coronary sinus and then cinch the band. And what you can see is this is the coronary sinus that we started with. Cinches the coronary sinus. And with that, the mitral valve annulus.

Amar Krishnaswamy, MD:

With that, you can see this patient's MR went from very significant to the follow-up MR really trivial kind of regurgitation. This device has been trialed in a few relatively small European trials. These three that you see here demonstrating a reduction in regurgitant volume that's durable out to one year compared to those patients at one year who are not treated, also reductions in LV volume out at one year compared to those patients who weren't treated. Now, importantly, Dr. Samir Kapadia, who's our head of Cardiology, he's the global PI of this EMPOWER trial of the Carillon device in 300 patients randomized, 150 to treatment and 150 to control. The primary endpoint is a broad one, including mortality.

Amar Krishnaswamy, MD:

But what I would also point out is the option in these patients for an alternative therapy if the Carillon is inadequate to reduce the mitral regurgitation to a clinically acceptable level. These patients can then be treated with a combination therapy with the MitraClip or move on to a mitral valve surgery. Now, importantly, what we have found over time with the Carillon device is that coronary sinus annuloplasty actually influences LV remodeling and reduces LV chamber size. This is in mild to moderate FMR patients, as well as large ventricle patients. One very unique aspect of this EMPOWER trial, which was actually just finalized with the FDA this past week, was that this trial is going to focus on including LV dilation, not simply mitral valve regurgitation.

Amar Krishnaswamy, MD:

We will be enrolling patients with at least mild FMR, but only grade one or larger, but specifically those patients with a dilated ventricle. We're hoping that we'll be able to treat patients at an earlier stage of their ventricular disease, hopefully not progressing to that significant MR and worsening LV mechanics and dilation. Moving on then briefly to transcatheter mitral valve replacement, this is a patient with a very wide functional MR. You can see the entire mitral valve does not coapt. It would be very hard for us to treat this adequately in a percutaneous strategy. This is a patient that we brought for a transapically delivered Tendyne mitral valve replacement prosthetic.

Amar Krishnaswamy, MD:

You can see here the sheath going into the ventricular apex. Here's the valve in place on the right inside of its frame. And you can see here once the valve is in place, really no residual mitral valve regurgitation. More importantly, for patients who have really no options, who are elderly with mitral valve stenosis, there's a subgroup analysis in this trial to treat patients that look like this with severe mitral valve stenosis and, again, placing a Tendyne into place, into position. I should say. Importantly, the TMVR or catheter mitral valve replacement landscape is quite broad. We do use a number of these different prosthetics as part of different clinical trials.

Amar Krishnaswamy, MD:

What you can see here is that the transapically delivered valves have the greatest amount of patients treated and data that transfemorally delivered devices are simply a bit more infant in their iterations, but procedural success has been quite high as far as treating the mitral valve regurgitation. Mortality in these groups is somewhat high at 30 days, really by function of the fact that these are patients enrolled who have no other options and are quite highly comorbid. Just briefly moving on, this is a 76 year old with a degenerated surgical valve. I think, importantly, the percutaneous therapies are an important adjunct in the portfolio of treatments we have as interventionalist cardiac surgeons and cardiologists.

Amar Krishnaswamy, MD:

This is a patient with a degenerated surgical valve with severe stenosis at this point. And oftentimes what we do for these patients to try to avoid a redo mitral valve surgery, which is often complex with difficult recovery in these elderly patients, is to bring them for a catheter valve replacement, which is usually performed under conscious sedation with patients leaving the same evening. You can see here the surgical valve in place, the transcatheter valve being positioned from the femoral vein. Again, this is under conscious sedation. The valve is expanded into place and the patient leaves the same evening.

Amar Krishnaswamy, MD:

Concluding, this is another issue that can happen over time with degeneration of surgical valves, a paravalvular regurgitation, as you see here, the surgical valve in place. Posterior medially, the significant regurgitation outside the valve frame. Posterior laterally here, the same thing. What we do is implant these plugs here, usually the vascular plugs, by placing a two to three millimeter catheter from the femoral vein into that space. And once the plugs are in place, as you can see here, we have in the posterior medial leak, we've turned to the posterior lateral position, placed more plugs with trivial residual regurgitation.

Amar Krishnaswamy, MD:

To conclude, the MitraClip is an excellent therapy for high surgical risk patients with degenerative mitral regurgitation. The contemporary clip is a major advance with quite encouraging results. Functional mitral regurgitation therapy is often more complex than degenerative MR. And while edge-to-edge repair can be very effective for patients with focal disease, more diffused FMR may be better suited to annual therapy or catheter-based mitral valve replacement. The subgroup registries of TMVR for native mitral stenosis, patients are underway and are so far promising.

Amar Krishnaswamy, MD:

Valve-in-valve therapy is effective and safe for degenerated surgical valves and paravalvular regurgitation is well suited to percutaneous therapy, especially for patients whose annulus may be unsuitable for a redo cardiac surgery. Thank you very much.

Announcer:

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