Recently, the annual TCT 2021 conference has been successfully concluded online. The results of a number of blockbuster studies on valvular disease alone have been announced at this conference, which has brought an excellent learning experience for the majority of doctors and scholars. Professor David J. Cohen, one of the authors of the PARTNER 3 study, was invited to conduct an in-depth discussion on the latest results of the trial and practical guidance value and other related issues.
1. International Circulation: At this conference, you will share the two-year economic outcomes of PARTNER 3. Could you share us the main content of the latest research?
Professor David J. Cohen: Yes, those results were just presented this past week at the TCT Conference. The results of the study were very positive for transcatheter aortic valve replacement (TAVR). We found that the initial procedures were much more expensive with transcatheter aortic valve replacement by about $19000, because the price of the TAVR valve is much more expensive. But there were a lot of cost savings that happened downstream. The hospitalizations were much shorter by about 4 1/2 days. Patients were much less likely to need to go to rehabilitation or have home health services when they went home. And in the early period after the procedures, they were less likely to be rehospitalized. So at the end of the initial hospitalization, the costs were very similar between TAVR and surgical aortic valve replacement, and then over the next 24 months, there were another $2600 worth of cost savings, so at the end of two years, the cost savings were about $2000 less with TAVR than it was with surgical aortic valve replacement.
In addition, we found that the patients had better outcomes. There was a little bit (a very small amount, but meaningful) of additional survival in the TAVR group. And there was also a better early quality of life in the TAVR group. We measure that in what is called quality adjusted life years, which were about 0.05 greater with TAVR than it was with surgical aortic valve replacement. When we put all of this together, the two-year cost effectiveness was very favorable with TAVR. It was what we call economically dominant, which means less costly and with better outcomes. That was the case 84% of the time when we re-ran the trial. It was cost effective at a value threshold of $50000 per quality adjusted year of life gained, which is considered a very high value in the United States. It was cost effective at that threshold about 95% of the time. So it was very favorable for TAVR, but that is at the two-year time point. We don’t know what is going to happen from two years to the rest of their lives, and that is obviously very important, so we did some additional analyses and certainly what we see is that as long as the results of TAVR that we have seen so far hold up, that there is no catch up from surgery, then these results will be sustained out through ten years and probably through the patients lifetime. But, if there are differences in long term survival, even very modest differences, that could change the equations, change the calculations, and make surgery the more cost effective alternative. We need longer term follow-up to answer that question.
2. International Circulation: The results of PARTNER 3 and Evolut low-risk trials have proved the safety and effectiveness of TAVR in patients with low surgical risk. Then, for patients with severe aortic stenosis (AS) with low surgical risk, can TAVR be completely replaced SAVR?
Professor David J. Cohen: That’s a great question. I think the answer right now is no. There are still roles for both procedures. The surgical aortic valve replacement for the low risk patients is a very safe, very effective procedure. Certainly what I believe is that for patients where the valve anatomy is not ideal for TAVR, those patients should still be getting treated with surgical aortic valve replacement, because, again, we don’t want to trade a low risk, straight-forward surgery for a higher risk, very complex TAVR. Those circumstances include patients with very calcified left ventricular outflow tracts, patients at high risk of coronary obstruction, or patients with bicuspid valves that are very bulky. Those are areas where clearly surgery still has a role. The other area is when surgery needs to be combined with other procedures. So if the patient has very complex coronary disease that is not appropriate for PCI, then surgery with a combined aortic valve replacement and bypass surgery is probably still the best option. TAVR has come a long way. TAVR is appropriate for many patients at low risk, but not for all.
3. International Circulation: What are the challenges of TAVR application in low surgical risk patients?
Professor David J. Cohen: The biggest risk is planning for the future. Many of the low risk patients that we see are in their 70s or their 60s. Those patients are very likely going to outlive their first valve replacement, and need another valve replacement. Anticipating that and planning so we can safely do another TAVR procedure is very important. That has to do with assessing the anatomy, knowing what the height of the prosthesis is, and planning in advance for something that might or might not happen. So I think that is still the area that is one of the very biggest challenges - what we call lifelong management of valve disease. Planning for the future, and I think that is a critical factor when performing TAVR these days.
1. International Circulation: At this conference, you will share the two-year economic outcomes of PARTNER 3. Could you share us the main content of the latest research?
Professor David J. Cohen: Yes, those results were just presented this past week at the TCT Conference. The results of the study were very positive for transcatheter aortic valve replacement (TAVR). We found that the initial procedures were much more expensive with transcatheter aortic valve replacement by about $19000, because the price of the TAVR valve is much more expensive. But there were a lot of cost savings that happened downstream. The hospitalizations were much shorter by about 4 1/2 days. Patients were much less likely to need to go to rehabilitation or have home health services when they went home. And in the early period after the procedures, they were less likely to be rehospitalized. So at the end of the initial hospitalization, the costs were very similar between TAVR and surgical aortic valve replacement, and then over the next 24 months, there were another $2600 worth of cost savings, so at the end of two years, the cost savings were about $2000 less with TAVR than it was with surgical aortic valve replacement.
2. International Circulation: The results of PARTNER 3 and Evolut low-risk trials have proved the safety and effectiveness of TAVR in patients with low surgical risk. Then, for patients with severe aortic stenosis (AS) with low surgical risk, can TAVR be completely replaced SAVR?
Professor David J. Cohen: That’s a great question. I think the answer right now is no. There are still roles for both procedures. The surgical aortic valve replacement for the low risk patients is a very safe, very effective procedure. Certainly what I believe is that for patients where the valve anatomy is not ideal for TAVR, those patients should still be getting treated with surgical aortic valve replacement, because, again, we don’t want to trade a low risk, straight-forward surgery for a higher risk, very complex TAVR. Those circumstances include patients with very calcified left ventricular outflow tracts, patients at high risk of coronary obstruction, or patients with bicuspid valves that are very bulky. Those are areas where clearly surgery still has a role. The other area is when surgery needs to be combined with other procedures. So if the patient has very complex coronary disease that is not appropriate for PCI, then surgery with a combined aortic valve replacement and bypass surgery is probably still the best option. TAVR has come a long way. TAVR is appropriate for many patients at low risk, but not for all.
3. International Circulation: What are the challenges of TAVR application in low surgical risk patients?
Professor David J. Cohen: The biggest risk is planning for the future. Many of the low risk patients that we see are in their 70s or their 60s. Those patients are very likely going to outlive their first valve replacement, and need another valve replacement. Anticipating that and planning so we can safely do another TAVR procedure is very important. That has to do with assessing the anatomy, knowing what the height of the prosthesis is, and planning in advance for something that might or might not happen. So I think that is still the area that is one of the very biggest challenges - what we call lifelong management of valve disease. Planning for the future, and I think that is a critical factor when performing TAVR these days.
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