Valve Disease Guidelines: Impact on Clinical Practice

Podcast Transcript

Announcer:
Welcome to Cleveland Clinic Cardiac Consult, brought to you by the Sydell and Arnold Miller Family Heart, Vascular and Thoracic Institute at Cleveland Clinic.

Dr. Lars Svensson:
I'm Lars Svensson and chairman of the Heart and Vascular Institute here at the Cleveland Clinic, and with me today is Marc Gillinov, chairman of the Department of Thoracic and Cardiovascular Surgery. And we thought we'd talk to today about the new valve guidelines that recently came out. And the great thing is, we think that this is a great step forward and in keeping with our practice. Marc, what were the most striking things from the document that you saw?

Dr. Marc Gillinov:
In reading this document, which is very well-referenced, the two most important takeaways that I had concerned first, when to have your valve treated, interventionally or surgically, and second, where to have it treated. There has for a long time been this idea that let's wait until someone feels bad, wait until someone has symptoms. And the guidelines say clearly, don't do that, don't wait until you have heart damage. If your valve is severely dysfunctional, get it fixed soon.

Dr. Marc Gillinov:
Because the valve is broken, it's not going to fix itself and it's going to cause heart damage. So that's the when, early. Second is where. Valve surgery and valve interventions are areas of expertise. You need to go to a person, to a doctor and to a center that is a center of excellence to get the best outcome. It's like everything else in life, practice makes perfect or close to perfect. The more you do, the more we do, the better we get. You as the patient, you as the referring cardiologists, want the very best and most experienced people you can get.

Dr. Lars Svensson:
Great. Marc, any thoughts about the somewhat new classification? It's very logical as far as asymptomatic, symptomatic and treatment of patients. Let's cover first aortic valve disease and then mitral valve disease.

Dr. Marc Gillinov:
I think what the guidelines do here is they recognize that the disease is a continuum. And that even the asymptomatic person or the person who lets say just has mild aortic stenosis requires very careful follow up because valve disease tends to progress. And therefore, the person shouldn't say, "Well, I was told I had mild aortic stenosis or mitral valve prolapse. And I think I will go away from the cardiologist for 10 years." Rather, it requires constant follow up so that the appropriate timing of intervention is clearly identified.

Dr. Lars Svensson:
Any thoughts about the various types of tests that we do and how we maybe should test patients going forward in relation to the guideline suggestions?

Dr. Marc Gillinov:
Well, of course for valves, echo remains the single most important test, but then there is a role for a stress echo. Oftentimes the symptoms from valve disease, and I know in your patients, my patients, they're subtle. Somebody says, "I feel pretty good," and then the person's husband or wife says, "Yeah, but in walking from the parking lot to the doctor's office, you stopped three times." And the patient says, "But I'm asymptomatic." We can actually quantify that now I think with stress echo, and you probably use a fair number of stress ECHOs.

Dr. Lars Svensson:
Well, that's true. We do a lot more testing now and certainly for aortic valve stenosis. We do a lot of stress ECHOs and the new guidelines introduced the idea that an asymptomatic patient, for example, a velocity of more than five meters per second, as a consideration for surgery. I think one of the important things about the guidelines, which they stress is that the TAVI or TAVR in the new guidelines, they call it TAVI instead of TAVR, there's a history to that. When I met with CMS, CMS suggested we call it aortic valve replacement to get better funding. And I've talked to some of the authors of the guidelines.

Dr. Lars Svensson:
There was a lot of discussion, but the phraseology knew that guidelines are back to TAVI. But what they stress in the guidelines is that the big prospective randomized trials like the partner trials was in symptomatic patients, not asymptomatic. And so, for asymptomatic patients where there's evidence of progressive aortic valve stenosis and disease, and especially with the regurgitant valves, the options are surgery. And that is highlighted in that. So, let's talk a bit about the choice of valve types and maybe some of the age bracketing, as far as aortic valve processes. Any thoughts about that mechanical, biological, tell all.

Dr. Marc Gillinov:
Certainly in the United States and in Western Europe, the tendency has been to have biological valves implanted across most age groups. And today, one of the key distinguishing features of surgical biological valves is this, we know their durability. And at this point we don't yet know the durability of the valves implanted by TAVI and that raises important questions. If you're, let's say a 55 year old person, and you prefer a bioprosthetic valve because of lifestyle considerations and that's right in the age group, 55, mechanical bioprosthetic both are good choices, but many prefer the bioprosthesis. We can look the person in the eye and say. "Your surgical bioprosthesis is going to last you a certain number of years, generally 10, a decade or more." And we can't yet say that for TAVI and I think that that should inform the decision, how do you frame it?

Dr. Lars Svensson:
Yes, that's a good point. And in meeting with patients as the guidelines now stress, is that we discuss with the patient, the options of biological valves versus mechanical valves. And the cutoffs that the guidelines suggested is less than 50 mechanical valves, 50 and older to an option is a biological or mechanical valve. And then they suggested that over the age of 80, TAVI is the recommended procedure and is quite a high ranking. So, one A, although I'm not aware of any literature that specifically recommends that for patients older than the age of 80. And in fact, a few years ago, and we'd looked at our patients 90 years and older, who we operated here at the Cleveland Clinic. There were no deaths in that population.

Dr. Lars Svensson:
And just as an aside in the last three years, we've only had one death for an isolated aortic valve. And for mitral valves, we haven't had a death since 2014 September for mitral valve repairs. So, the discussion is one to be had with a patient. How much are they prepared to tolerate a re-operation versus dealing with Coumadin? And part of that conversation obviously is, if you have a biological valve and you're a young person, you probably should plan to have another open heart operation. Turns out here at the Cleveland Clinic, patients who have re-operations for isolated aortic valve have the same risk as a primary valve. That doesn't particularly increase the risk although it is a big operation. And then the third procedure would plan to be a TAVI or TAVR in that replacement valve.

Dr. Lars Svensson:
I often tell patients, depending on their age, let's say if they 50 and they are planning to use a biological valve, and that's what they'd like, that they should plan to have the next operation as an open heart, and then after that consider TAVR. I think the combination of biological valve, and then let's say 10 years later, a TAVR and then plan to have a repeat open heart operation is not a good combo. And particularly since the RFS areas typically reduce by valve and valves. So, in summary, who has a TAVR in a previous replace aortic valve, usually a second TAVR is not a good idea. Let's talk a bit about the mitral valve. What struck you as new, obviously operating much earlier, something that we've emphasized a lot.

Dr. Marc Gillinov:
In addition to operating earlier, there is the clear recommendation for valve repair in degenerative mitral valve disease. And there is a bar set at 95% repair rate with mortality, less than 1% for an asymptomatic person with degenerative disease or prolapse. And as Dr. Svensson said, here at the Cleveland Clinic, for isolated mitral valve repair in a patient with degenerative disease, our operative mortality is less than one in a thousand. So, our real goal is zero and we're very close. Our repair rate for isolated degenerative disease exceeds 99%. So, we feel like surgery has progressed to the point that we can offer an incredibly safe operation, particularly for those who are asymptomatic with excellent repairability and very good durability. And therefore, given this data, the guidelines recommend a MitraClip only in the sickest patients who are not candidates for surgery.

Dr. Lars Svensson:
So Marc, you do a lot of robot surgeries. You're a world expert and you guys have fantastic results of over 2,000 patients now, I think with only one patient that you've lost. How do you fit robotic mitral valve repair surgery into the spectrum of mitral valve procedures you do? And maybe also touch on your sort of five critical steps in doing a mitral valve repair.

Dr. Marc Gillinov:
When we look at someone with isolated degenerative disease, our first thought is we must do the safest operation with a mortality less than one tenth of 1%, and we must repair the valve. And then the next consideration is, can we do this robotically or minimally invasively with an incision, something like this big. I mean, it's wonderful to see today is Friday, the person I did robotic surgery on Monday, he's already home. And the one who had a Tuesday is going home today. These people really, they don't even look like they had heart surgery, but I guarantee it was an operation on the inside, but on the outside they don't look like it and they feel better. So, we would like to offer the robotic approach to as many people as possible. We have a very strict screening algorithm, so that we choose the right procedure and right approach for the individual patient.

Dr. Marc Gillinov:
We still will do a sternotomy on occasion, someone needs two valves. There's aortic regurgitation, they need bypasses or are there some contraindication. But we begin with the idea safe repair, done minimally invasively. Those are our goals for everyone who comes with isolated degenerative disease. Then as to what Dr. Svensson was touching on is how to repair the valve. Some people would have you believe that you must be Michelangelo or Leonardo da Vinci to repair a mitral valve. I can assure you, it is not that complicated or demanding. Starting with Toby Cosgrove years ago, we've developed a systematic approach that honest to goodness works in almost all patients.

Dr. Marc Gillinov:
For posterior leaflet prolapse, we either use artificial cords or do a resection. If somebody has posterior leaflet prolapse, and they have a high risk of systolic anterior motion and left ventricular outflow tract obstruction or SAM, we do a resection with a sliding repair. So we've got resection, resection with sliding repair, artificial cords, those are three maneuvers. A fourth maneuver, if there is prolapse at a commissure at one extreme end of the valve, close the commissure, that's the fourth maneuver. Fifth maneuver, put an annuloplasty band or ring. With those five maneuvers, you can repair 95% of the valves. And this is what we teach our trainees, who come here from around the world to learn the principles of mitral valve repair. You only really need to know how to do five things to get almost all the valves repaired.

Dr. Lars Svensson:
There was a brief section in the guidelines about managing the aorta in particular, bicuspid valves. And that is a result because of in the 2010 guidelines on thoracic aortic disease, we had a recommendation to operate at five centimeters to 5.0 centimeters in bicuspid valves. And that algorithm, as far as the cross sectional area and ratio to height, for indication for surgery. The subsequent valve guidelines had a different set of guidelines related to the aorta and bicuspid valves. There was then a statement put out by us and the ACC that is an age, A, reconciling those and the most recent guidelines basically mirror the most recent joint statement, namely that in centers of excellence surgery should be considered an asymptomatic enlarged aorta from five to 5.5 centimeters depending on risk and taking into account also, what we do, the patient's height. The other thing there was very brief mention about valve preservation, re-implantation operations. And, we now, as of December last year, had done 1,113 re-implantation here at the Cleveland Clinic and the wonderful thing is the results are very good and very similar to that of mitral valve repair.

Dr. Lars Svensson:
So, 97% freedom from re-operation 10 years after surgery, which is really excellent results. When you consider that young people with leaking valves can have the valve repaired and re-implanted, and they don't have to be on Coumadin, and they don't have to have a mechanical valve. They don't have to have a biological valve that will fail, but they'll really have excellent long-term results. And a more recent look at our 214 patients with Marfan or connective tissue disorders, there were no deaths and the results look very similar to the general population, which is very reassuring. Finally, let me just touch on one other thing that was highlighted in the guidelines, and that was the tricuspid valve and management of patients with isolated tricuspid valve. Marc, what are your thoughts about tricuspid valve disease, how you manage it and what's your indications for managing the tricuspid valve when you're doing a mitral valve?

Dr. Marc Gillinov:
Well, the first principle when you're doing a mitral valve operation, first principle is make sure you look at the tricuspid valve with the echo and not the intra-operative echo so much as the preoperative echo. If on the preoperative echo, there is moderately severe or severe tricuspid regurgitation for sure address the tricuspid valve at the time of mitral valve surgery. And almost always, almost always, that tricuspid valve can be repaired. Controversy arises when you talk about somebody who's got tricuspid regurgitation, that's moderate or less with or without annular dilatation or isolated annular dilatation, we don't yet know whether we should treat those tricuspid valves or not.

Dr. Marc Gillinov:
But I think if there is pulmonary hypertension or right ventricular dysfunction and the tricuspid valve has moderate regurgitation or angular dilatation, you should treat it. For isolated severe tricuspid regurgitation, surgery can be complicated. Sometimes that is caused by pacemaker defibrillator leads traversing the valve, sometimes it's caused by severe right ventricular dysfunction. And I think surgery is indicated, but there you really need a center of excellence because the tricuspid valve in these sorts of patients can be tricky to repair, and also management of the right ventricle can be challenging.

Dr. Lars Svensson:
Let me just briefly summarize also where we are with TAVR or TAVI. Here at the Cleveland Clinic, in 2019 we did just under 700 TAVRs with no deaths. Last year, 2020, even though we had the pandemic, we again did just under 700 patients with three deaths. So very few. So, the results of TAVR are excellent. The concern is the longer term durability, and we have some data showing that the durability may not be as good as Marc emphasized as compared to open aortic valve replacements. And in the paper that we wrote that was published in the new age of immense December, now a year and a bit ago, there was evidence that the stroke risk and the risk of death was catching up. In fact, it had increased more than the open valve replacements. And the guidelines rightly say that until we have better long-term durability, one should be cautious in younger patients.

Dr. Lars Svensson:
And as we mentioned, in asymptomatic patients at this time, TAVI is not approved and similarly for bicuspid valves. And there are some concerns with TAVI and bicuspid valves of evidence of a higher stroke risk. And that's not surprising given the lot of calcium that's found in bicuspid valves. So, thank you very much for listening to us and just some quick soundbites on our interpretation of the guidelines. I think on the whole, the guidelines were very balanced perhaps on the conservative side, but rightly so, the science needs to be confirmed before it's implemented in guidelines. And we certainly congratulate the authors of the guidelines for writing a very well balanced article manuscript, and also bringing in new tests that help us to decide when to recommend surgery for patients apart from being symptomatic. Thank you very much.

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