Indications and risks vs. benefits of TAVR aortic stenosis treatment or open heart surgery aortic valve replacement are changing all the time. Leading heart surgeon explains. Which patients benefit most from the transcatheter aortic valve implantation, TAVI, or transcatheter aortic valve replacement, TAVR? Dr. Anton Titov, MD. How to choose correct heart valve replacement method? Minimally invasive aortic valve replacement vs. open heart surgery. Dr. Marc Pelletier, MD. Yes. Minimally invasive aortic valve replacement is is moving forward rapidly. The answer to that question is changing all the time. When TAVR / TAVI started about 10 or 15 years ago, we really didn't know how patients would react. We didn't know how durable the TAVR valves would be. At the beginning the TAVR technology was fairly early, or primitive. Sometimes there was a leak of blood around the replaced aortic valve. Sometimes there were complications that we couldn't predict. When TAVI started, it was for patients who were very high risk for surgery. TAVR was for patients who could not have surgery at all. The TAVR / TAVI procedure is meant to treat aortic stenosis. Dr. Marc Pelletier, MD. Aortic stenosis in reality happens mainly in older patients. Often patients with aortic stenosis need an operation. They are in their 70s or 80s, or sometimes in their 90's. They're sicker, they're older. So for them to go through a big open heart surgery is a really big deal. Sometimes we know that they are not going to survive that operation. At the beginning there were a lot of patients who were very sick. Patients were too sick for heart surgery. There was nothing that we could do for them. Then TAVI / TAVR came along. It was just wonderful for some of those patients. Some of my early patients are in their 80s. They have aortic stenosis. They are not very mobile. Dr. Marc Pelletier, MD. All of a sudden you do a small operation like that. They are home in a couple days. It changes their life completely. However long they have to live. Dr. Anton Titov, MD. So as time has gone on, the TAVR aortic valves have gotten better. TAVI procedure has gotten much safer. Now all kinds of patients are starting to be good candidates for TAVR. In the US we are still governed by the FDA. The FDA has told us that we can do TAVR / TAVI in patients who are deemed to be intermediate risk for open heart surgery. US FDA views open aortic valve replacement surgery still as the gold standard. It's a very reproducible, predictable operation with excellent results. The FDA has said. If patient's operative risks are more than 3%, they are classified into an intermediate risk category. Sometimes their operative risk is more than 8%. It is a risk that they will die during or after open heart surgery to replace aortic valve. So they are high-risk. Dr. Marc Pelletier, MD. Patients are intermediate risk or high risk. It means their operative risk is 3% or higher. Then we are allowed by the FDA to consider a TAVI / TAVR procedure. The next step will then be to assess their cardiac anatomy. We have to see if patient’s arteries are large enough. We have to decide if the aortic valve is suitable to do a TAVI / TAVR procedure. But those are mainly the the patients who will benefit from that. There are patients who are still very low risk for open heart surgery. We think still that they have a bit better outcome with open heart surgery to replace their aortic valve. Dr. Marc Pelletier, MD. Open heart surgery is more predictable. It gives a better long-term result for replaced aortic valve. But that is changing. There are aortic valve replacement surgery clinical trials going on right now. I wouldn't be surprised if indications for TAVI / TAVR aortic valve replacement will change. Perhaps within the next four or five years we will do TAVI / TAVR on patients who are at lower risk for surgery. Are indications for TAVI / TAVR procedure different in Europe vs. the United States? Dr. Anton Titov, MD. How indications for TAVR TAVI precede in Canada compare with the regulatory issues in the United States? Dr. Marc Pelletier, MD. Yes, regulations are different. The Europeans have made more advances in terms of what they are able to do. The regulatory area for TAVR / TAVI is a little bit different in Europe. Germany and France have been able to do TAVI earlier and more liberally than we have here in the United States. That changed couple of years ago. The FDA really leapfrogged over Canada, as an example. US FDA overtook other countries by allowing newer TAVI devices. They allowed a more liberal use of the TAVR devices. But I would say this. Dr. Marc Pelletier, MD. Here in the US and in Canada we are still far behind our European colleagues. They have access to newer TAVI devices much more rapidly than we do. Europeans have newer techniques more rapidly than we do. Dr. Anton Titov, MD. There is a more liberalized use of aortic valve replacement techniques than we do here in the US. TAVR use is more governed by the FDA here. There are different payer mechanisms, insurance mechanisms, or limitations and things of that nature.