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SOLVE-TAVI: Valves, anesthesia strategies confer similar outcomes in symptomatic aortic stenosis
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SAN DIEGO — A self-expanding valve was equivalent to a balloon-expandable valve for 30-day outcomes in patients with symptomatic aortic stenosis who underwent transfemoral transcatheter aortic valve replacement, according to data from the SOLVE-TAVI trial presented at TCT 2018.
In addition, local and general anesthesia strategies during TAVR resulted in similar outcomes, according to the study.
Patients assigned to the balloon expandable heart valve (Sapien 3, Edwards Lifesciences) may have resulted in higher stroke rates compared with those assigned the self-expanding valve (CoreValve Evolut R, Medtronic), but the valves were associated with similar 30-day rates of a composite of stroke, all-cause mortality, permanent pacemaker implantation and moderate or severe prosthetic valve regurgitation.
Holger Thiele, MD, director and full professor of internal medicine/cardiology at Heart Center Leipzig at University of Leipzig in Germany, and colleagues analyzed data from patients who were assigned to the self-expanding valve (n = 219; mean age, 82 years; 48% men) or the balloon-expandable valve (n = 219; mean age, 82 years; 50% men).
Patients were also assigned to local (n = 218; mean age, 82 years; 49% men) or general anesthesia (n = 220; mean age, 81 years; 49% men).
The primary endpoint for the valve strategy component of the trial was all-cause mortality, stroke, permanent pacemaker implantation and either moderate or severe prosthetic valve regurgitation at 30 days. This occurred in 27.2% of patients assigned to the self-expanding valve and 26.1% of those assigned to the balloon-expandable valve (rate difference = –1.14; 90% CI, –8.15 to 5.87; P for equivalence = .02; P for superiority = .83).
Regarding the individual components of the primary endpoint, the self-expanding valve and the balloon-expandable valve groups had low mortality rates (2.8% vs. 2.3%, respectively; P for equivalence < .001; P for superiority = .77). More patients assigned the balloon-expandable valve had a stroke vs. those assigned the self-expanding valve (4.7% vs. 0.5%; P for equivalence = .003; P for superiority = .01).
There were low rates of moderate-to-severe valve regurgitation (self-expanding group, 1.9%; balloon-expandable group, 1.4%; P for equivalence < .001; P for superiority > .99), although there were high rates of pacemaker implantation in both groups (self-expanding group, 22.9%; balloon-expandable group, 19%; P for equivalence = .06; P for superiority = .34).
The primary endpoint for the anesthesia strategy was stroke, all-cause mortality, MI, acute kidney injury and infection requiring antibiotic treatment at 30 days. This was seen in 27% of patients assigned local anesthesia and 25.5% of those assigned general anesthesia (rate difference = –1.52; 90% CI, –8.47 to 5.42; P for equivalence = .02; P for superiority = .74).
For individual components of the primary endpoint for anesthesia strategy, the local anesthesia group and the general anesthesia group had similar rates of mortality (2.8% vs. 2.3%, respectively; P for equivalence < .001; P for superiority = .77), stroke (2.4% vs. 2.8%, respectively; P for equivalence = .002; P for superiority > .99), MI (0.5% for both groups; P for equivalence < .001; P for superiority > .99), infection requiring antibiotics (21% in both groups; P for equivalence = .005; P for superiority > .99) and acute kidney injury (8.9% vs. 9.2%, respectively; P for equivalence < .001; P for superiority > .99).
“General anesthesia is associated with a higher rate of catecholamine use, but does not affect procedure times, valve-related outcome or clinical outcome,” Thiele said during a press conference. – by Darlene Dobkowski
Reference:
Thiele H, et al. Late-Breaking Trials 3. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.
Disclosure: Thiele reports no relevant financial disclosures.
Perspective
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Molly Szerlip, MD, FACC, FACP, FSCAI
It was a well-done trial. We all would like to know if one type of valve is better than another (balloon expandable vs. self-expanding). In 80% or 90% of the cases, they are equal.
The answer to this question is still not known. We think that in some populations, one may be better than the other. As mentioned during the press conference by Michael J. Mack, MD, FACC, it is like a Venn diagram in the majority of populations, it probably does not matter.
For the general anesthesia vs. conscious sedation question, it is probably more important for us in the U.S than in Europe. In Europe, they do things a little bit differently as far as length of stay and other factors, but for us here in the U.S., length of stay is a big deal. A shorter length of stay, which usually occurs with local anesthesia, decreases cost.
This once again shows that there is no harm in using conscious sedation. In some cases, there may be better outcomes if you do conscious sedation because it decreases length of stay.
Perspective
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Vinod H. Thourani, MD, FACS, FACC
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.
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