SOLVE-TAVI: TAVR Equally Safe With Balloon-, Self-Expanding Valves and General, Local Anesthesia

SAN DIEGO, CA—In patients at high risk for surgery who undergo TAVR, self-expanding and balloon expandable devices are associated with similar safety at 30 days, with no differences between procedures done under local versus general anesthesia, according to results of the randomized SOLVE-TAVI trial.

“The fact that trials like these are being done is a testament to how far this technology has evolved,” said Ori Ben-Yehuda, MD (Cardiovascular Research Foundation, NY), in a media briefing. “We’re not asking the question anymore whether TAVR is valid or not, but rather which device, and that's a testament to all the work that's been done in the field.”

Holger Thiele, MD (Heart Center Leipzig – University Hospital, Germany), presented the results today in a late-breaking trial session at TCT 2018. Among 447 German patients randomized to TAVR using either the Evolut R (Medtronic) or Sapien 3 (Edwards Lifesciences) valves, there were no differences for the combined primary endpoint of all-cause mortality, stroke, moderate/severe valve regurgitation, and permanent pacemaker implantation at 30 days (27.2% vs 26.1%; P = 0.02 for equivalence). Notably, there was a higher stroke rate among patients in the Sapien 3 arm (0.5% vs 4.7%; P = 0.01), and the rate of permanent pacemaker was higher than expected by the researchers in both arms (22.9% vs 19.0%; P = 0.06 for equivalence).

There were also no differences in the combined primary outcome of all-cause mortality, stroke, MI, infection requiring antibiotics, and acute kidney injury at 30 days among patients receiving general anesthesia and conscious sedation (25.5% vs 27.0%; P = 0.02 for equivalence). The composite outcome was driven by a high but similar rate of infection in both arms (21% for both; P = 0.005 for equivalence).

90% of Patients Can Go Either Way

In the media briefing, John Webb, MD (St. Paul’s Hospital, Vancouver, Canada), said “the discussion about which valve is better is complicated.” For example, CoreValve (Medtronic) is useful in “very small annuli where you may have supra-annular leaflet function, so we're talking very small native annuli or very small surgical valves. . . . The other major area would be patients with calcification somehow involving the valve or the annulus itself. There may be room for a self-expanding valve. Some of us would argue with both of those, but I think there's a good argument that can be made.”

Molly Szerlip, MD (The Heart Hospital Baylor, Plano, TX), agreed, explaining that in 90% of aortic stenosis cases, it doesn’t matter which valve is used, and many institutions typically use one device over another. This is usually related more to operator experience or supplier relationships than clinical characteristics. However, with the recent publication of a subanalysis of the Sentinel trial that found the filter captured the largest particles when balloon-expandable valves are used, Szerlip said the stroke findings in this study are intriguing.

But Martin B. Leon, MD (NewYork-Presbyterian/Columbia University Irving Medical Center, NY), who was a co-principal investigator on the Sentinel trial and moderated the media briefing today, said, “We were very careful not to try and compare different valve types in the Sentinel trial, because we were so underpowered. But there were certainly trends from the standpoint of clinical strokes, debris capture, and neuroimaging that went in the other direction” of the SOLVE-TAVI trial.

With regard to the anesthesia angle of the study, Leon said “one of the reasons operators maybe use general anesthesia is the feeling at least in some patients the transesophageal echo [TEE] would be a helpful guidance tool during the procedure. I was struck by the fact that only 34% of the patients who had general anesthesia had [TEE]. At least for us, most of the time when we do general anesthesia, it’s almost for the purpose of using [TEE], so that seemed a little bit uncharacteristic.”

Thiele replied that this could have been because many of the institutions enrolled in the study had already made the switch to default conscious sedation and were essentially being forced to use general anesthesia because of the randomization and not because they wanted the added guidance of TEE.

Szerlip said that in the United States, “a lot of the reason why people use general anesthesia is because it’s the preference of the anesthesiologist. It's just a battle that is not waged. Maybe this will also give more validity to the fact you can do both. At our institution the anesthesiologists now prefer to do conscious sedation and not general anesthesia, so it's just kind of a paradigm shift that they have to get used to.”

Can these results be generalized at all to a lower-risk patient population? Somewhat, Thiele told TCTMD. “What our trial now has shown is that even in lower-risk patients you can easily go for local anesthesia with conscious sedation, so you don’t need general anesthesia and you can go now with the minimalist approach [to] maybe discharge this patient a few days or 1 day later after you have performed the procedure,” he said. “With respect to the valve comparison, it shows that the valves are equivalent and you can probably also go for lower-risk patients, but there are many, many other open issues. That's the reason we have to wait for low-risk trials like PARTNER 3 and Medtronic Low Risk.” These are “eagerly awaited,” he added.