TAVR vs. Open Heart Surgery for Aortic Valve Stenosis Treatment

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• TAVR and TAVI Terminology
• Evolution of TAVR Technology
• TAVR for High-Risk Patients
• TAVR for Intermediate-Risk Patients
• Unanswered Questions About TAVR
• Future TAVR Research
• Full Transcript

TAVR and TAVI Terminology Explained

Dr. Jeffrey Popma, MD, clarifies the terminology for this minimally invasive aortic valve procedure. TAVR stands for Transcatheter Aortic Valve Replacement. This is the common term used in the United States. TAVI stands for Transcatheter Aortic Valve Implantation. This is the European terminology for the identical procedure. The difference in naming is primarily related to clinical reimbursement and historical context. Both TAVR and TAVI refer to the same life-saving treatment for aortic stenosis.

Evolution of TAVR Technology and Adoption

The development of a less invasive technique for aortic valve replacement has a 10 to 15 year history. Dr. Jeffrey Popma, MD, notes that the technology available today is vastly superior to early systems. The primary goal was always to provide effective relief of aortic stenosis with a less invasive approach. This technological progress has led to rapid clinical adoption. Dr. Popma’s hospital has seen a massive increase in TAVR procedures. They progressed from performing two cases every other week to now completing six TAVR cases per week.

TAVR Outcomes for High-Risk Surgical Patients

Initial clinical trials for TAVR focused on patients deemed inoperable or at extreme high risk for open heart surgery. Dr. Jeffrey Popma, MD, explains that these early randomized trials yielded significant results. TAVR was proven superior to medical therapy for these high-risk patients. The procedure improved both the quality of life and the quantity of life. TAVR provided a less invasive option with a faster recovery, allowing patients to become mobile more quickly. This established TAVR as a critical therapy for patients who had no other surgical options.

TAVR for Intermediate-Risk Aortic Stenosis Patients

Research then expanded to include intermediate-risk patients. These are individuals with an estimated surgical risk of over 3% for 30-day mortality. The SURTAVI clinical trial used the CoreValve device to compare TAVR to surgical aortic valve replacement. Dr. Jeffrey Popma, MD, reports the pivotal findings presented at the ACC meeting and published in the New England Journal of Medicine. TAVR was proven to be non-inferior to surgery for intermediate-risk patients. The procedure was also associated with a more rapid improvement in quality of life and showed numerical reductions in strokes at 30 days.

Unanswered Questions About TAVR Durability and Safety

Despite its success, several important questions about TAVR remain unanswered. A primary concern is the long-term durability of transcatheter aortic valves compared to surgical valves. Dr. Jeffrey Popma, MD, highlights other specific considerations. Coronary artery access after a TAVR procedure can be more challenging. There is also a higher frequency of cardiac pacemaker implantation required after TAVR versus surgery. These factors are crucial for determining the best treatment option for younger, healthier patients.

Future TAVR Research in Low-Risk Patients

Ongoing randomized clinical trials are now focusing on patients at low risk for surgical complications. Dr. Jeffrey Popma, MD, is involved in trials across the United States, Europe, Canada, and Australia. These studies are comparing surgical aortic valve replacement to TAVR using devices like the Evolut system and the Sapien valve (in the PARTNER 3 trial). The research aims to determine if TAVR is non-inferior to surgery in this healthier population. Additional research is needed for specific patient groups, including those with bicuspid aortic valve disease. The interview with Dr. Anton Titov, MD concludes by emphasizing that much has been learned, but more knowledge is still to be gained about TAVR.

Full Transcript

Dr. Anton Titov, MD: How to compare these two methods?

Dr. Jeffrey Popma, MD: A minimally invasive method of aortic valve replacement and open-heart surgical operation to replace aortic valve. You have actually brought up some very interesting terminology to start with.

First of all, you have mentioned the transcatheter aortic valve replacement or TAVR. That's the US version, which has to do with clinical reimbursement issues.

You have also mentioned the Transcatheter Aortic Valve Implantation, TAVI. It is the European terminology for the same procedure, because that has been more of an intervention rather than a replacement. We use TAVR and TAVI synonymously, but it must be very confusing to people when we talk about it.

Dr. Anton Titov, MD: One abbreviation is the US based, the other is of European origin.

Dr. Jeffrey Popma, MD: This whole journey about trying to do something less invasively has been a 10 to 15 year history. Certainly it has been an eight-year history for us here at our hospital.

We initially felt that some sort of lesser invasive technique for helping patients is good. We wanted to have relief of their aortic stenosis, which was a very laudable goal.

The technology that we had in the early days was very different. The technology that we have available today is better. Things have really changed.

We began our early comparisons of aortic valve surgery versus TAVR in the United States. We took the patients who were deemed to be inoperative, meaning they were not able to have a regular aortic valve replacement operation.

Those patients were extremely high-risk. We did randomized clinical trials on those patients. TAVR came out to be superior both in terms of improvement of quality of life and quantity of life. These are very important metrics.

In addition, TAVR was less invasive. Patients were moving around a little bit more quickly.

About five years ago we started a clinical trial with the CoreValve device called SURTAVI. That was implanted into intermediate risk patients, those that had a risk of over 3% from 30-day mortality after surgery.

We did a randomized clinical trial with TAVR. We presented that at the ACC meeting and published the results in the New England Journal of Medicine.

Sure enough, TAVR was not inferior to surgical aortic valve replacement. TAVI was associated with a more rapid improvement in quality of life. There were numerical reductions in strokes 30 days after surgery.

We found that TAVR is really a preferred therapy for aortic valve stenosis. But the durability of the aortic valve is not fully known.

Nevertheless, TAVR is a lesser invasive procedure for patients to be able to become more mobile. Today there has been a rapid acceleration of growth of the transcatheter aortic valves, especially in patients who are intermediate or higher risk.

TAVR is almost the preferred therapy. We are looking at outcomes, looking at patients, looking at how many patients will get treated.

We have gone from two TAVR cases every other week to now six TAVR cases per week.

Dr. Anton Titov, MD: That is really accelerated in terms of the growth for patients.

Dr. Jeffrey Popma, MD: But we still have some unanswered questions on TAVR compared to open heart aortic valve replacement surgery. We don't know whether TAVR is not inferior to aortic valve replacement surgery in some patients, specifically those who are low risk for surgical aortic valve replacement.

Dr. Anton Titov, MD: Sometimes I said to you, "Your chance of making it to 30 days and not having a stroke is 97% or greater." It is true for aortic valve replacement surgery in low-risk patients.

You should say, "That sounds like a pretty good deal!" I get an aortic valve that we know a lot about. It is going to be durable. That has been the only operation for a while.

We don't know if the durability of our newer aortic valves. We are not fully confident in the issues related to coronary access.

There are matters related to cardiac pacemaker implantation. It does occur with more frequency with TAVR than with the surgical aortic valve replacement. We don't know those issues.

So we are doing a randomized clinical trial now here in the United States, and in Europe, Canada, and Australia. We will randomize patients who are low-risk to either surgical aortic valve replacement or to use of the Evolut developed systems.

The Sapien TAVI device that PARTNER 3 clinical trial is running a similar trial across the world. We have really made a lot of progress.

In patients who are at high risk for surgery, probably TAVR is a very reasonable choice. For patients over 80 to 85 years of age, probably TAVR is a reasonable choice because the recovery is so much quicker.

But we haven't sorted out how the TAVR aortic valve performs yet in the lower risk patients.

Dr. Anton Titov, MD: How TAVI aortic valve performs in patients with bicuspid aortic valve disease? How TAVI aortic valve performs in patients who are much younger?

Dr. Jeffrey Popma, MD: Because we don't understand the TAVR valve durability. A lot is in flux right now. We have learned a lot about TAVR, but we have a lot more to gain as well.