It is refreshing to see randomized trials comparing one transcatheter valve to another. In Europe, there is a multitude of valves that are commercially available. In the U.S., we only have two, so luckily, they chose the two valves that we have available. I imagine it was intentional.
What I saw is that it is a small-powered study. That was probably the thing that we have to be cautious about, but what they show is that there is no major difference between the valve types for the primary endpoint. The primary endpoint was a composite endpoint. That was a good way to look at it.
When you look at the individual components of it, mortality is not a difference. Stroke rate surprisingly was higher in Sapien 3, and we have shown it to be in the U.S. the same trial using this patient population has been a lot less than that. I am a little surprised to see that component of it.
As expected, the pacemaker rate was higher with the self-expanding valves. That was not a huge surprise, but it was surprising that the Sapien 3 valve had a higher pacemaker rate than what we had published in the past.
There is an important difference between the current U.S. practice and what we have just seen with SOLVE-TAVI: The patient risk is higher than we are normally used to seeing. For instance, the STS score was somewhere in the high 7% range. What we are seeing in the U.S. is somewhere around 4% to 5%. That is a high-risk patient population in the U.S. Now in the TVT registry, we are seeing medium-risk patients. It is not 100% extrapolation.
As far as the paravalvular leak rate goes, that also was equivalent between the two, so that is something that was refreshing to see.
Even though now we are looking at this globally, we have to start honing in on which valve is better for what anatomical consideration. They did not do that necessarily, but that is something that we have to dive into a little bit more.
When it comes to local anesthesia vs. general anesthesia, it was quite surprising that the length of time to do the procedure was not different between the two. You would think that with general anesthesia that it would take longer, but it did not.
They used different primary endpoints for that, but that also showed no difference between the two groups. That was quite refreshing to see that either technique works well for you.
Really at the end of the day, it is whatever the operator is used to. They should use that type of valve and use that type of anesthesia technique.
Some reports have said that there is a higher paravalvular leakage rate with conscious sedation, but that was not really prevalent in this study. It was refreshing to see that, that can be done well.
What I take away from SOLVE-TAVI is that in experienced high-volume centers, the type of valve nor the procedure technique does not make a significant difference. Although this is overall an underpowered study, it does give comfort for those people using self-expanding valves and it gives comfort to those using balloon-expandable valves.
Vinod H. Thourani, MD, FACS, FACC
Director, MedStar Cardiac Surgery Program
Chairman, Department of Cardiac Surgery
MedStar Heart and Vascular Institute
Disclosures: Thourani reports he has relationships with Abbott Vascular, Boston Scientific, Edwards Lifesciences, Gore Vascular, JenaValve and Medtronic.