A. Pieter Kappetein, MD, PhD

Disclosures

June 06, 2014

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Recovery From Surgery Can Be Lengthy

A. Pieter Kappetein, MD, PhD: Hello. I'm Pieter Kappetein, Professor of Cardiothoracic Surgery in Rotterdam, The Netherlands. I'm here at EuroPCR in Paris, where I chaired some of the sessions on transcatheter aortic valve implantation (TAVI) or replacement (TAVR). In Europe we say TAVI, while in the United States you say TAVR. There are some important messages here at the meeting. There are some take-aways.

The good thing is that we hear progress in TAVI implantation. There are fewer complications, and patients are doing better and better with TAVI. One of the major news points, of course, was that the US pivotal trial with the CoreValve® (Medtronic, Inc.; Minneapolis, Minnesota) showed for the first time that this high-risk patient population did better with TAVI than with surgery.[1] As a surgeon, of course I have to take this very seriously because it means that some of the patients we currently treat [surgically] who are old and have comorbidities might be better off with TAVI.

Five or six years ago, there was no other option. Patients who would come in with severe symptomatic aortic stenosis, although they were old or had major comorbidities or even had a heart operation in their history, were offered surgery. We could do that with a pretty low risk in terms of hospital mortality, but it took patients quite a long time to recover in the hospital, about 10-14 days. After they were discharged from the hospital and went back home, it took them 3-4 months before they were back to normal.

Of course, in an 80-year-old or an 85-year-old, the life expectancy is not that long. For the mean population, if you're 80 years of age in my country, The Netherlands, your average life expectancy is about 7 years. That means that if you take away 3 or 4 months in recovery after transaortic valve implantation, you take away quite a large part of that patient's life expectancy.

Heart Team Beats Risk Score

The beauty of TAVI is that it will move from this extreme-risk to high-risk and probably also the intermediate-risk patients. We still have to define the intermediate-risk population. When you discuss this with surgeons and cardiologists, we always look at STS score and we look at EuroSCORE, but these are derived from patients who were operated on. I think that the heart team is important with not only the surgeon and cardiologist sitting together but also noninterventional cardiologists, geriatricians, pulmonologists, and anesthesiologists who weigh the risk of the patient undergoing surgery vs the benefits of surgery and then weigh the risk/benefits of TAVI.

The risk scores are a little bit helpful in that they can guide you on the important risk variables, but the most important thing is that the doctors sit together and look at the patient (hopefully they see the patient in the outpatient clinic) and then make a judgment on what kind of treatment they should offer to the patient.

Fewer Complications With Advanced Technology

With the advancement of TAVI, we see fewer complications. The advances are in the field of repositional or resheathable valves. This is a nice feature, especially when you begin doing TAVI implantation, because the position is not determined within 2 or 3 seconds. You can still adjust the valve. You can take it back, and you can find a better position. Hopefully with this new feature we will reduce the paravalvular leakage. It may also allow us to perhaps implant the valve a little bit higher in the outflow tract and thereby reduce the pacemaker implantation rate. This is a major advantage, especially when you don't have a lot of experience with transcatheter valve implantation, but I think it also helps centers that have a lot of experience with the more difficult patients -- for example, those with horizontal aorta or transverse aorta, where it's more difficult to get the valve into the correct position.

The other advantages are that the sheath sizes are getting smaller, so that will reduce the bleeding rates, the vascular complication rates. We also see with SAPIEN 3 (Edwards Lifesciences Corporation; Irvine, California), for example, that the sheath size for transapical has become smaller. While surgeons always said that the sheath size is not as important as it is in transfemoral implantation, we experienced with the SAPIEN 3 implantation that it does matter. The new system is smaller; its 18 French. The puncture hole at the apex of the heart is much smaller and thereby it's much easier to close, and the bleeding complications there will decrease as well. I think that is really a major step forward.

Transapical Here to Stay?

There are still some drawbacks with transapical valve implantation, including that patients have more pain after the procedure. Hopefully with smaller sheath size and perhaps transapical closure devices we will be able to make smaller incisions in the chest wall and thereby not spread the ribs to get better access, and that will certainly decrease the postoperative pain. Transapical is still here to stay because there will be patients who cannot be treated with transfemoral implantation.

Of course, we have other access routes. We have subclavian and we have direct aortic access. At this meeting, we heard that the direct aortic access is becoming more routine in several institutions; it's the second route of choice after transfemoral. Direct aortic access, on the other hand, means that you have to do a small sternotomy; and, of course, you have a small risk for mediastinitis. In my institution at Rotterdam, we still prefer transfemoral first, then we use subclavian, then we use transapical, and last but not least we have direct aortic access. But it depends very much on the institution where you are. Those institutions that do not have a lot of experience with subclavian but do have it with direct aortic access, they will put that as their second or third option. It depends a little bit on the experience that you have.

Of course, the beauty of subclavian, direct aortic access, and transapical is that you have a shorter distance to the aortic valve annulus; thereby, the positioning might be a little bit easier. In the coming year there will be a lot of discussion on which patients to do transfemorally and which ones should have a different access route, thereby hopefully decreasing the vascular complications and bleeding complications from the groin. We have to consider access route in the heart team discussions as well -- so, not only the indication for the procedure but also which route to use.

Reducing Paravalvular Leak and Pacemaker Need

Paravalvular leakage is, of course, another important issue. The new valves allow for better positioning, which may decrease paravalvular leakage. The SAPIEN 3 has been shown to decrease paravalvular leakage[2] thanks to the skirt that it has around it. Paravalvular leakage may also decrease with better sizing. A CT scan is now the gold standard, not echocardiography. The CT allows you to better size the valve, get a better valve size choice, and thereby reduce paravalvular leakage. Whether CT scan will be replaced by 3D echo is something that we will need to see in the future, but currently CT is the gold standard.

Then, of course, the pacemaker implantation rate is another issue. We have seen with self-expanding devices that the pacemaker implantation rate is higher (vs balloon expandable devices) and can be up to 20%-25%. There is some indication that perhaps in this very elderly patient population, pacemakers might prevent sudden death. Maybe, in the elderly patient population, pacemaker implantation is not a big issue. But I think that once you move to intermediate-risk patients or even low-risk patients, pacemaker implantation will become an issue because then patients need to live much longer with not only a transcatheter heart valve but also with a pacemaker. Pacemakers need to be replaced after a certain amount of time. Pacemakers are, of course, a foreign body in the human body and are vulnerable to infections. It will not be a large percentage, but there will be a small percentage of patients who will have complications with pacemakers. That's something that we have to determine in the future when we implant more of these valves in younger patient populations.

Durability and Valve-in-Valve

The question that was discussed a lot at the EuroPCR meeting is: How far can we go with transcatheter heart valve implantation? Is durability a concern? For bioprosthetic heart valves, we always estimate that the life expectancy of the valve is about 10-15 years; some even say very optimistically that it may last up to 20 years. These numbers are usually based on reoperation-free data and not on real valve failure. Patients weren't always systematically followed by echo. I have my doubts because we now see more valve-in-valve patients, and we see that the mean time between the surgical valve implantation and transcatheter heart valve implantation is around 9 years. If those valves really last much longer (15-20 years), this means that the number of years between valve implantation and the TAVI valve seems to be a little bit out of place.

Then there is the durability issue with transcatheter heart valves; of course, we can only find that out when we have enough patients with 10 or 15 years of follow-up. So far we have not seen any dramatic reports saying that a lot of these valves are failing. Actually, it's quite optimistic that we don't see many people coming back. In fact, the first patient who was treated in Rotterdam almost 9 years ago is still alive, and the valve is functioning normally. So, we can be a little bit optimistic that at least the durability might be as good as bioprosthetic heart valves.

That brings us to the point where we ask if we could lower the age when we implant surgical bioprostheses. I don't think it's right to argue that you can do a valve-in-valve in those patients. Suppose you have a 50-year-old patient with a bioprosthetic valve that may last 10-15 years. That means that patient will get to 65 years of age. You would then have to give that patient a valve-in-valve, and the valve-in-valve might last another 10-15 years, which means that the patient may live up to 75 years. Then that patient would need a valve-in-valve-in-valve.

I think it's great that we have surgical valve implantation for those patients when we implant the bioprosthesis over the age of 65 years, because then when they are 80 or 85, we can offer them a less invasive approach. You do not need to reoperate on them but can give them TAVI in a surgical aortic valve.

These are important points to consider and the main things that I learned at this meeting. In the coming years, we will learn more about the durability of transcatheter valves, how we can further reduce paravalvular leakage, and how we can reduce pacemaker implantation. The new valves that come on the market will have smaller sheath size, so there will be reduction of vascular complications. What will be the preferred access route? Will transapical still be used, and trans-subclavian, direct aortic access? Then, of course, we will wait for long-term results of patients. Hopefully patients will live longer with these valves.

Living longer is one point, but of course we also want to give the patients a better quality of life. That is something we should not forget. As doctors, we very much focus on treating patients right away and getting them out of the hospital, but one thing we need to learn is how frailty plays a role in this. There are patients in whom you can do the procedure, and they can be discharged from the hospital, but do they really improve? Do they just trade one disease for another disease? As doctors, we have to take that into consideration as well.

These were important points at EuroPCR in Paris. Thank you very much for your attention.

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