When repairing the mitral valve in an operating room, should the tricuspid valve be repaired at the same if it is leaking? Cardiac surgeon, James Gammie discusses why and how this would happen and what the effects were.
mm. Hello. I'm dr James Gammy from johns Hopkins and it's my privilege to be presenting at the upcoming american Heart association meeting, the results of an important trial uh that addresses the a key surgical question in the treatment of heart valve disease. Mm This was a trial in by way of background uh is focused on valvular heart disease. Uh And in particular patients with mitral regurgitation, mitral regurgitation is leakage of the mitral valve and it is the most common valvular disorder uh in the United States and around the world. There's more than 50,000 operations that are done every year in the United States for mitral regurgitation. And also by way of background, there's another valve on the opposite side of the heart called the trick a spit valve. And the trick. A spit valve is often impacted by a leaky mitral valve. So a lot of our patients that come for mitral valve surgery have leakage of the trike a spit valve because the blood backs up across the pulmonary circulation and it stretches the borders of the trike a spit valve, it dilates and it causes try custard regurgitation or try custard leakage and so commonly were faced with the dilemma about whether or not to do concomitant surgery on the track, a spit valve at the time that we're either fixing or replacing the mitral valve and we grade the amount of leakage of the trike. A spit valve is mild, moderate or severe. I think there is general agreement among surgeons that if there's severe leakage of the trick, a spit valve that we should fix it and we have a good way of fixing it by placing a rigid, cloth covered metal ring, an annual plasticky it's called around the periphery of the valve and that narrows down the opening of the valve and it takes away the leakage. And I think there's little controversy about what to do with severe trickle speed regurgitation. However, we're not sure how to manage moderate or even less than moderate leakage, particularly when there's dilation of the Trick. A spit valve. And there's a lot of um where there has been a lot of controversy within our field and great variability in practice. For example, overall, presently about a third of patients with a moderate tricastin leakage will get repair at the time of mitral valve surgery And different centers approach this differently. And the rates of concomitant repair are as low as 5% in some centers and as high as 75% in other centers mm. The reason that we want to fix the valve at the time of surgery is to prevent progression of the leakage. We know that sometimes the leakage of the trick, a spit valve goes down when we fix the mitral valve but it's not reliable and it has been demonstrated that some patients will have progressive leakage of the trick a spit valve and that can cause shortness of breath. It can cause fluid accumulation and importantly, it's been shown to be an independent predictor of long term mortality. So that sets the stage for this trial. And it was carried out at 39 centers including in the United States Canada and in Germany. And it was also in part supported by the german heart foundation. And we took patients that had the most common form of a leaky mitral valve. It's called degenerative mitral regurgitation. And they either had a moderate leak of the trick, a spit valve or they had less than moderate and a stretched or dilated trick a spit valve. And we took 401 patients and we randomly assigned them to either get mitral valve surgery alone or mitral valve surgery with trick, a spit valve repair and one of the shortcomings of surgical trials is that sometimes surgeons do things a lot of different ways. One of the powerful aspects of this trial was that we got agreement amongst the surgeons To use the specific type of device, the specific size of device. It tended to be small. What we call undersized and rigid and non planar. So that was the setting. We screened over 5000 patients, 800 and some were eligible for the trial 401 agreed to participate. And we carried this out between 2016 and 2018 and the primary endpoint of the trial was assessed two years after surgery and it was a composite endpoint of either death re operation for try custard regurgitation or progression of try custard regurgitation to severe try custard regurgitation. We also looked at a number a host of secondary endpoints including quality of life, major adverse events, the performance function and size of the right ventricle and whether the patient was admitted for heart failure and overall how well they did. And so the key findings of the trial first of all was that the operative mortality amongst these 401 patients was extraordinarily low. It was less than 1%. And I think this speaks to the effectiveness and safety of isolated mitral valve surgery. And then the key finding was the treatment failure as defined by our composite and point of death re operation for Tricastin regurgitation or severe tr was more frequent in the group that did not have the trike a spit valve fixed. And the numbers were that 10.2% of patients achieved the primary endpoint in the mitral valve surgery alone. Whereas we only saw that in 3.9% of those patients where we fixed the trick a spit valve at the time of surgery. The two year mortality was really not particularly different and really the main driver of the primary endpoint was progression of severe try custard regurgitation, which we saw in 5.6% of patients that were not treated. And we saw that in only 0.6% one patient out of 179 patients where we put the annual plastic ring in place had progressed to severe track hospital regurgitation. We found that the repair of trickle speed insufficiency or regurgitation did come at a cost. Those patients were on the heart lung machine for approximately 34 minutes longer in the operating room. They also had a median length of stay in the hospital at least in Canada, the United States of two days. So it took longer on the bypass machine and they had a longer postoperative length of stay. And then very importantly, we know as surgeons that repairing the trick, a spit valve with an annual plastic ring Uh sometimes increases or does increase its well well known that it increases the risk of a patient needing a permanent pacemaker after the operation. And we did find a significant difference in the need for a permanent pacemaker. The pacemaker implantation rate was 14% in the group where we fix the track husband valve But it was only 2.5% in the group where we did not have to fix the truck hospital valve. Um and then finally, or two other points I would make is that the presence of either moderate or severe trikus speed regurgitation in comparing the two groups was substantially higher. In the group where we did not fix the trick a spit valve, it was 25%. A quarter of patients had progressed to either moderate or severe trek hospital regurgitation in that group. Whereas we only saw that in three and a 1/2% of those patients where the trick a spit valve was fixed. Mm. So this is an important trial because it is the first time that we have high level evidence to help us understand what to do in the operating room. I'm not sure that we have absolute clear guidelines here, but I think that we now know that uh progression of tR is very effectively arrested with a use of triclosan valve repair with a ring. But we also know that it comes at a cost of increased pacemaker implantation. Uh importantly, our patient population is a young patient population typically in their sixties and these patients generally have a normal life expectancy after uh mitral valve surgery, mitral valve surgery. And so uh this trial has been designed to continue to follow the patients out to five years and it will be very important for us to do that. And we look forward to reporting the results of the five year assessment and whether there's further progression of try customer regurgitation in the untreated group and whether or not that has an impact on their clinical outcomes. Mm hmm, mm hmm mm.
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