Choosing Between TAVR and Open Heart Surgery for Aortic Stenosis

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• Evolution of TAVR Technology and Patient Selection
• Understanding Patient Risk Categories for Aortic Valve Replacement
• Benefits of Open Heart Aortic Valve Surgery
• The Future of TAVR Indications and Clinical Trials
• Global Regulatory Differences in TAVR Approval and Use
• Full Transcript

Evolution of TAVR Technology and Patient Selection

Dr. Marc Pelletier, MD, describes how TAVR technology has advanced significantly since its inception. The procedure began over a decade ago for patients deemed inoperable or at extreme high risk for open heart surgery. Early TAVR devices were more primitive and associated with complications like paravalvular leak. Dr. Marc Pelletier, MD, notes that TAVR is a wonderful option for older, sicker patients in their 70s, 80s, and 90s who need aortic stenosis treatment.

The safety profile of the TAVI procedure has improved dramatically. This allows patients to return home within days and experience a life-changing recovery. Dr. Anton Titov, MD, facilitates this discussion on the rapid progress of minimally invasive aortic valve replacement.

Understanding Patient Risk Categories for Aortic Valve Replacement

Patient risk assessment is central to choosing the correct aortic valve replacement method. Dr. Marc Pelletier, MD, explains the current FDA guidelines that govern TAVR use in the United States. Open aortic valve replacement surgery remains the gold standard, offering reproducible and predictable results.

The FDA classifies patients with an operative risk of 3% or higher as intermediate risk. Patients with a risk above 8% are considered high risk. For these groups, TAVR is an approved treatment option. A patient's cardiac anatomy must also be suitable for the TAVI procedure, including having arteries large enough for device access.

Benefits of Open Heart Aortic Valve Surgery

For low-risk surgical patients, open heart surgery often provides a superior outcome. Dr. Marc Pelletier, MD, states that the traditional operation is more predictable and offers better long-term durability for the replaced aortic valve. This is a crucial consideration for younger patients or those with a longer life expectancy.

The proven track record of surgical aortic valve replacement establishes it as the benchmark. Dr. Anton Titov, MD, and Dr. Pelletier discuss how this landscape is continually evaluated against advancing TAVR technology.

The Future of TAVR Indications and Clinical Trials

The indications for TAVR are expected to expand in the coming years. Dr. Marc Pelletier, MD, references ongoing clinical trials comparing TAVR to surgery in lower-risk patients. He would not be surprised if within four or five years, TAVI becomes a standard option for patients at lower surgical risk.

This evolution depends on continued improvements in valve durability and procedural safety. The conversation with Dr. Anton Titov, MD, highlights the dynamic nature of aortic stenosis treatment guidelines.

Global Regulatory Differences in TAVR Approval and Use

Regulatory approval for TAVR devices and techniques varies significantly across the globe. Dr. Marc Pelletier, MD, explains that European countries like Germany and France have historically had more liberal access to newer TAVI technology. They adopted these procedures earlier and more rapidly than the United States or Canada.

Although the FDA has recently approved newer devices, the US still operates under stricter governance. Dr. Pelletier concludes that payer mechanisms and insurance limitations also contribute to these international differences in aortic valve replacement care.

Full Transcript

Dr. Anton Titov, MD: Indications and risks versus 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.

How to choose the correct heart valve replacement method? Minimally invasive aortic valve replacement versus open heart surgery.

Dr. Marc Pelletier, MD: Yes, minimally invasive aortic valve replacement is moving forward rapidly. The answer to that question is changing all the time.

When TAVR or 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 or TAVI procedure is meant to treat aortic stenosis. 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 90s. 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 or 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.

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.

Dr. Marc Pelletier, MD: In the US, we are still governed by the FDA. The FDA has told us that we can do TAVR or 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.

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 or 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 or TAVR procedure.

But those are mainly 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. 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 or TAVR aortic valve replacement will change.

Perhaps within the next four or five years, we will do TAVI or TAVR on patients who are at lower risk for surgery.

Dr. Anton Titov, MD: Are indications for TAVI or TAVR procedure different in Europe versus the United States?

How indications for TAVR TAVI proceed 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 or 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 a 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. 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.

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.