Percutaneous Valve Innovations: Transcatheter Aortic Valve Replacement

Can you describe your center and TAVR program?

Clinique Pasteur in Toulouse is the lead center in France for interventional cardiology and cardiology in general, with more than 3000 percutaneous coronary interventions (PCI) per year. I am the head of the structural heart disease program at this institution. We are on track to do 600 transcatheter aortic valve replacement (TAVR) procedures this year, so it is really the biggest center in France, with more than 700 surgical aortic valve replacements per year as well. We are focusing more and more on structural heart disease and valvular pathology in particular.  

Tell us about your current TAVR patient population. Are you doing intermediate risk patients?

This is a very good question. The issue in France is that we have to stick to the requirements for reimbursement for economic purposes. Thus far, we have been treating inoperable or high-risk patients. However, more and more often, we are seeing that the patients we are treating are trending toward intermediate risk. Last year, we conducted a survey and recorded all the patients that were entering the hospital. The survey revealed that we have already started to treat intermediate risk patients. There has been a decrease in the Society of Thoracic Surgeons (STS) score over time. We were glad to see the publication of the PARTNER II trial results, showing the benefit of TAVR in intermediate risk patients when compared to surgery, confirming our strategy.

Can you give us an overview of the research in which you are currently involved?

Our main focus is exploring the issues remaining with TAVR. We have demonstrated that vascular complications, bleeding, and transfusion have an adverse impact on the outcome of the patient and on survival. This is something that the industry has tried to tackle in order to decrease the rate of vascular complications. Recently, we have been involved in various registries exploring the outcomes of new generation TAVR devices, because we have the opportunity and access to all these new iterations of devices and new technologies. Another one of our research studies focused on stroke, trying to understand the actual frequency of stroke post TAVR. Stroke is more frequent than we think: in our study, 50% of strokes were procedure-related. Stroke does have an impact on survival of the patient, so it is an issue we have to improve upon in the future if we want to see a better outcome for our patients, especially if we anticipate the expansion of TAVR indications to low-risk patients. Finally, I am conducting a study along with other teams on bicuspid disease. It remains one of the challenges of TAVR, and we need to understand more about its incidence, the way to size the valve, and treat bicuspid patients. 

Can you share more about clinical needs of the TAVR procedure that remain unmet?

We must first focus on outcomes. The remaining issues are related to the TAVR procedure itself. Stroke is one of these issues for certain. We have been improving vascular complications, but there is room for improvement in terms of device iteration. In terms of indication, we need dedicated devices for bicuspid disease, but also for pure aortic regurgitation and perhaps for failing surgical aortic bioprostheses. We have been using the commercially available devices, but these are not perfect. If we had specific devices available for pure aortic regurgitation, bicuspid anatomy, and for failing bioprostheses for valve-in-valve procedures, this would be wonderful. 

How are these needs reflected in terms of percentages within your patient population?

Pure aortic regurgitation has not really been explored, because we don’t have any suitable devices to treat these patients, so right now we are not really focusing on that population. We need to think about 10-15 years ahead. In the field of transcatheter aortic valve intervention, we need to explore the various aspects of aortic valvular disease further. At this time, maybe less than 5% of our patients suffer from pure aortic regurgitation. The bicuspid population is larger: perhaps 15-20% of our patients are bicuspid patients. For valve-in-valve, it may be about 10% of the patients we are treating. If we assume that in the future patients are going to be treated in greater numbers with surgical bioprostheses rather than mechanical ones, in 15 to 20 years, we will have to deal with a large number of failed bioprostheses and we will really need dedicated devices for that population.

In order to move towards more widespread adoption of the TAVR procedure, what do you recommend for device developers?

First, if you want to increase the use of a device, it has to be simple to use. Ease of use may be a primary focus. The device has to be simple in terms of deployment and extremely improved in terms of profile to decrease the rate of vascular complications. Retrievability is an interesting feature, because it provides additional safety and comfort to the procedure. It is preferable to bring a device that is easily deployed and immediately at target, but let’s imagine that we fail to achieve an optimal position; in such a scenario, retrievability is a very good feature. A reduced profile, ease of use beyond deployment, and retrievability are the main characteristics of the optimal TAVR device in the future. 

What is going to happen to device profiles?

It is only a matter of time, but we are going to see devices that are 12 French compatible. The question is, do we have to go below 12 French, because the price we will have to pay could be a decrease in the durability of the leaflets. It may be wiser to remain 12-14 French compatible, which is already small and allows for the treatment of the vast majority of the patients we are seeing at the hospital. So while the valve profile will decrease, it won’t follow the same path as coronary stents. I am not sure that we will see 6 to 8 French compatible devices. If we have something that is 12 French, it may be the limit in the future. 

What about alternative access? 

In Toulouse, we have been pushing the boundaries somewhat and we are treating almost all our patients via transfemoral access. We are doing about 95% of our cases via transfemoral route. Since we have the ability to use various devices with various profiles, we can offer a transfemoral device to the vast majority of our patients. In the future, if we think about streamlining the procedure and making it so we can utilize it in the vast majority of the centers, transfemoral is going to be the main access, in almost 100% of the cases. There will still remain room for alternative access, but I don’t see any further development in alternative accesses in the future. Maybe the simplest one will remain. Whether it will be subclavian or transapical, I don’t know, but less invasive will be better, so perhaps in the future, the subclavian access will be preferred if the patient is not suitable for transfemoral access. In 2016, it’s not exactly the same picture, but if we jump to the 2020s, we will see that with improved devices, the vast majority of patients are transfemoral, and only a very small minority will have subclavian or another alternative access.

What will happen with imaging?

There are a few aspects to consider. First is the screening. During the screening phase, multidetector computed tomography (MDCT) will remain the gold standard in terms of sizing and preparation for the procedure. The second aspect is during the procedure. In order to make it safer for the patient in terms of acute renal failure and acute kidney injury, we have to decrease the contrast load that we give to the patient. We will see dedicated software that superimposes CT images with fluoro landmarks in order to decrease the amount of contrast that we give to the patient during valve deployment. All these tools that are not optimal in 2016 are going to improve in the future. Co-registration tools are going to be used more and more in order in order to decrease the contrast load. 

What about echocardiography?

Echo will remain, but in terms of simplification of the procedure, it won’t be transesophageal echo (TEE) anymore. We already see this in European centers that are using less and less TEE during the procedure. It is more about transthoracic echo at the start to make sure there is no complication. TEE is not used to guide the deployment; this is done with fluoroscopy guidance. In order to shorten the procedure and offer better recovery, there will be no general anesthesia and no TEE. This already is occurring in our practice, and I don’t see any persistence of TEE guidance in the future if we have the opportunity to use safer, more stable, and more precise devices for deployment. 

What about TAVR technologies in other areas such as aortic insufficiency? How do you see this technology expanding?

It will certainly expand, because the physicians and the manufacturers will learn from our current experience. We will have dedicated devices for pure aortic regurgitation. We will also have dedicated devices for the mitral valve — I am not talking about the transcatheter mitral valve replacement, but, for example, mitral valve-in-valve. We are already using TAVR devices to treat failed mitral bioprostheses. It may be that we will have dedicated devices for that indication, as well as for mitral annular calcification. We need dedicated devices for these indications and they could be based on the current TAVR platform, but with some iterations and improvements.

As the TAVR procedure evolves, what will happen to the heart team approach?

The heart team is going to remain. It will probably change in its composition and in the way the operators perform during the procedure. What I see in the future is the heart team as a guarantee of a discussion loyal to the patient, in terms of indication — whether or not to send a patient to surgery or TAVR. The procedure will be simplified. We will see devices utilized by a senior operator, whether a surgeon or a cardiologist, so in the future, there won’t be a need for so many operators in the room. The heart team will continue in its importance regarding pre procedure planning, making sure that we select the best and safest approach for the patient. I anticipate fewer and fewer complications in the future, so there will be less need to combine different skill sets from a surgical and an interventionalist point of view. 

Any final thoughts?

In the future, what we will improve is the overall management of the patient. What about antithrombotic treatments? In terms of pharmacology, we will see improvements. There are ongoing trials trying determine the best strategy to decrease the stroke rate, because if 50% of strokes are periprocedural and 50% are post procedural, we need more ability to decrease the spontaneous risk of the patient. We will also better understand which patients can be treated through an early discharge program. Also, with safer procedures, there is a real need for a decrease in the pacemaker rate, which is the Achilles’ heel of TAVR, in my opinion. In the future, if we can decrease the pacemaker rate, we can think about PCI-like procedures for TAVR. This is a trend that is already seen in Europe. With improvements in technology, a decrease in the rate of pacemakers, and improvements in pharmacology for protection of patients, we are going to see an increase in early discharge. All these trends will help to increase the volume of TAVR.

Recommended reading

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Disclosure: Dr. Tchétché reports no conflicts of interest regarding the content herein.

Dr. Didier Tchétché can be contacted at dtchetche@clinique-pasteur.com