Expert Interview: The Latest on Percutaneous Intervention in Structural Heart Disease

Dr Rasha Al-Lamee; Prof Bernard Prendergast

Disclosures

June 08, 2018

Dr Rasha Al-Lamee: Hello, I'm Rasha Al-Lamee, and I'm an interventional cardiology consultant at the Hammersmith Hospital. And I'm here today with Bernard Prendergast, consultant cardiologist from St Thomas' Hospital, and an expert in structural heart disease, and we're here at the EuroPCR conference with Medscape UK.

So, Bernard, obviously, I'm much more of a coronary doctor and you're here predominantly representing the structural space. Now, obviously, we've seen TAVI, and the intervention and the structural intervention in terms of percutaneous intervention has been quite incredible actually over the last 5 to 10 years I'd say, and things that have happened and the things we now do I guess we wouldn't have expected all those years ago. Are you still excited by the space? What do you expect to be coming next?

Professor Bernard Prendergast: Am I still excited about the space? Very much so because it is still evolving at a rapid pace. And as was very clear at this meeting, and particularly the Innovators Day[1] Congress yesterday, there is a huge amount still coming down the track. So it's an exciting space to be involved with in terms of the clinical benefits to patients and the transformations that you can make for patients who otherwise have not had options.

It's quite stimulating to be taking on the surgeons in their sphere and offering a keyhole alternative to open heart surgery with cardiopulmonary bypass and all that that entails, and it's very exciting to be part of an innovation pipeline that is producing new devices and iterations of existing devices year on year.

Dr Al-Lamee: So, maybe I can take you up on that in terms of the new devices, we're here at EuroPCR and I know that yesterday you were at the Innovators Day. Which devices excite you at the moment and where do you think the device technology will be going in the next 1 or 2 years?

Prof Prendergast: So the bulk of the investment and the bulk of the innovation currently is focused around mitral and tricuspid valve intervention.

You could say that TAVI is largely a done deal although iterations are still underway but we have an established safe technique that is simple, applicable, in most centres with very very good results. But the real creativity is coming in the mitral and tricuspid arena. I think there are two areas that are being addressed actively at the moment by both innovators and investigators. The first is to identify solutions for the patients where the current devices don't provide the answer because of anatomical constraints or the complexity of the pathophysiology.

The second is trying to make the existing procedures, so edge to edge repair for example, easier so they can be applied beyond specialist hands in small numbers of centres. So that's where the real concentration, and the focus is currently, and trying to take the procedures which are currently transapical, and try and make them transeptal because that will make it even less invasive, less risky, and more accessible in the hands of interventional cardiologists.

Dr Willie Stewart, a leading British neurosurgeon who has been at the forefront of improving assessment of head injuries in football and rugby union, said medical teams told BBC Sport they were "handcuffed" by a lack of adequate help.: So maybe I can take you up on that mitral space. So obviously with the original MitraClip data[2] that we had out there, there was obviously disappointing data that came out in the very early days. How has that technology evolved? Where do we see mitral and percutaneous mitral intervention going?

Prof Prendergast: Okay, well, 2018 you could say is the year of the MitraClip. So the first procedures were done 15 years ago remarkably, albeit in small numbers and with a learning curve associated with them, but 15 years is a significant anniversary of any device.

So several things have happened. The first is that the procedure has become simplified in the hands of experts so they get better, more reproducible results. The second is that the device has gone through several iterations of improvement so that it is easier to use, for example, rather than the requirement to capture both leaflets simultaneously, you can now capture them one by one. And of course, for most interventionists, that's a much easier thing to do. So the device is improving with time.

The other key factor this year is that we will have the next wave of randomised control trial evidence, not at this conference but the results of the MITRA-France study will be presented at the European Society [of Cardiology - ESC] in Munich in August. And one month later the results of the COAPT trial will be presented at TCT [Transcatheter Cardiovascular Therapeutics] in the US. And these are randomised controlled trials looking at edge to edge repair versus medical therapy for patients with functional mitral regurgitation or secondary mitral regurgitation. And clearly those results are going to be pivotal not only for edge to edge repair, but for the whole industry of mitral valve intervention. So watch this space.

Dr Al-Lamee: And do you think that that will have an impact on funding because of course it's been difficult in the UK to find funding for these procedures? It'll be interesting to see what those results will do in terms of being able to increase our ability to access these procedures.

Prof Prendergast: The results will be important because clearly if they're negative, that's going to be a very difficult place to manoeuvre from in an economically constrained environment. As you say the commissioning for these procedures isn't available at the moment. So we really do need a shot in the arm in terms of some evidence that will support what we're doing. The anecdotal evidence in the hands of high volume operators is that their procedures are making a big, big difference for patients. And I think we also need to recognise that the prognosis for patients with severe MR and heart failure is very, very poor. So if there is an intervention that can reverse that cycle, then that will be a major impact on not only mortality outcome, but also other economically important outcomes such as readmission to hospital with recurrent heart failure, which, you know, is a very big, big problem and associated with very prolonged hospital stays. So the economic advantage and the arguments should be quite strong to make if the results are positive.

Dr Al-Lamee: At St. Thomas' you have perhaps the most comprehensive programme of structural intervention in the UK and of course you're taking on procedures such as interventions on the tricuspid valve which many of the other centres aren't doing. Where do you see that space going? Because that's really something the surgeons have refused to touch over the years and they've been patients that have been really hard for us to manage, so who are you including in your programme?

Prof Prendergast: The tricuspid valve is a challenging valve anatomically in terms of its characteristics to perform percutaneous interventions on, so at the moment we are struggling to find good tools to treat the problem. There are a variety of approaches, tethering approaches, annular reduction. There are now some percutaneous tricuspid valves, and there are also valves that can go into the superior and inferior vena cava, and there's also a device that is a bit like a covered stent with a valve on the side, the Tricento device, which effectively provides an alternative to the native tricuspid valve. But all of these procedures are being undertaken in very small numbers in highly specialised centres. So we are fortunate at Thomas' that we do have early access to some of these technologies. We are trying to grow our imprint in the global research markets alongside our colleagues at King's College as part of the KHP Partnership [King's Health Partners]. And at the moment our greatest clinical experience has been with valve in ring and valve in valve procedures in the tricuspid position where we've had some absolutely spectacular outcomes and really transformed the clinical condition of patients.

Dr Al-Lamee: If I can take you back to the TAVI space because as you've said in terms of innovation, we've really got a number of devices that are fantastic. Do you see interventional cardiologists out there in the district general hospitals, perhaps in less specialised centres without surgical access, in the future, being able to implant these devices? Where do you think it will go?

Prof Prendergast: I think in the future is the important caveat in that sentence. Where we are at the moment is that ESC guidelines,[3] national guidelines,[4] stipulate that TAVI should be performed in a surgical centre. And I think there are two reasons behind that as I see it. The first is that if you have the need for a surgeon, you need them within 5 minutes, and you can't achieve that if you do it in a referring cath lab. It's much, much worse in other words than occluded coronary. And of course, an occluded coronary is very rare these days, which is why PCI is being done in non-surgical centres. But when catastrophes happen, they are major catastrophes and you need help quickly. And especially as we start to go down into younger patients and lower-risk cohorts. We can't take shortcuts, you know, we have to be offering the equivalent treatments to the gold standard, which is surgical AVR. And we can only do that if we have appropriate levels of safety.

At the moment we haven't reached capacity in the UK. TAVI operators are busy people like all interventional cardiologists, but we haven't exhausted the resources in terms of the numbers of procedures that could be done in the existing centres. And I think it needs us all to be a little bit more smart and savvy in how we use our cath labs, how we use our hybrid rooms and our ORs, and how we use the expertise of the TAVI operators to do the maximum number of procedures. So, for example, at Thomas' in the last year, we have doubled our output of TAVI with the same resources, the same number of operators, the same number of catheter labs. You just need to get smart with your scheduling and you need to make the procedure little bit lighter touch so that you can do more in each cath lab session.

Dr Al-Lamee: Thank you very much. I think today we've learned a lot about the future of percutaneous intervention in terms of structural heart disease. And there's lots out there and there's lots more to come. So thank you very much, Bernard. And thank you very much for watching.

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