My name is Santiago Garcia. I'm an interventional cardiologist at the Christ Hospital in Cincinnati, Ohio.

Could you tell us about the Navitor valve?

Yeah, this was an observational study from the TVT Registry looking at the Navitor valve. The Navitor valve is a new transcatheter valve that was introduced commercially in the United States in January of 2023.

It has some key features including [illegible] leaflets, a self-expanding nitinol frame with large cells designed to enable coronary access, has a skirt that is designed to mitigate paravalvular regurgitation and has a very consistent [illegible] across the different sizes of the device. This was commercially approved for the treatment of severe, symptomatic aortic stenosis in patients who were at high or prohibitive surgical risk.

What is the study design and patient population?

The study was an observational study, that took advantage of the TVT Registry. This therapy was commercially introduced in the US in January of 2023. And we look at the first two years of the commercial experience in approximately 3,000 patients with severe symptomatic aortic stenosis, high or prohibitive surgical risk and tricuspid anatomy. Patients with bicuspid anatomies or patients with valve-in-valve procedures or a non aortic stenosis indication for the TAVI procedure were excluded.

What are the key outcomes?

We look at several outcomes. The key outcomes from a clinical perspective were death and stroke at 30 days. Those outcomes were pretty much in line with what was described in the clinical trial. Mortality was about 2%, and stroke rates at 30 days were also about 2%.

Take into account that this was a high-risk population; the average age of these patients was 81 and the average ST score was 6.6. So a really high-risk population of patients. So these results should be interpreted in light of those observations.

We've also seen excellent hemodynamics with a mean gradient of 7 millimeters of mercury at 30 days and valve areas of about 2 centimeter squared. This is important because the patients that were treated with this technology in the study were mainly women with very small aortic [illegible]. The average diameter was 20 millimeters and about two thirds of the patients met the definition of a small aortic [illegible] use in the SMART trial.

We also observed significant improvements in quality of life, about a 20 point increase in the KCCQ overall score. The majority of patients, 92%, were in New York HEart Association Functional Class I, II at 30 days. And rates of significant paravalvular regurgitation defined as moderate or more were very low: 2% or less.

What further research is needed, and what are the next steps?

The next steps for this technology is to expand to low and intermediate risk patients. There is an ongoing clinical trial, called the ENVISION trial, which is comparing this platform Navitor vision against commercially available valves.

That study plans to enroll over 1,000 patients, it's ongoing right now in the United States and also Canada and some sites in Europe and hopefully will give us important information regarding the performance of this device in younger patients at lower risk for complications.