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SAN DIEGO -- Transfemoral transcatheter aortic valve replacement (TAVR) with the balloon-expandable Edwards Sapien 3 valve yields the same early outcomes as the self-expanding CoreValve Evolut R, regardless of anesthesia strategy, a two-by-two randomized trial showed.
In the valve comparison, the primary endpoint of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days met criteria for equivalence, with a composite rate of 27.2% with Evolut R and 26.1% with Sapien 3, Holger Thiele, MD, of University Hospital in Leipzig, Germany, reported here at the Transcatheter Cardiovascular Therapeutics meeting.
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
The researchers also evaluated the effects of anesthesia used during these procedures and found no significant difference. The composite endpoint at 30 days came out 27.0% for local anesthesia and 25.5% for general anesthesia.
"The SOLVE-TAVI trial is the first adequately powered randomized trial comparing local versus general anesthesia in patients with symptomatic aortic valve stenosis undergoing TAVR," said Thiele in a press release. "Results indicate that local anesthesia is both safe and effective and may be a good option for those patients undergoing TAVR with an intermediate or high surgical risk."
In the majority of aortic stenosis cases, it doesn't matter which valve you choose, although there are still some cases, like heavy calcification, when it may be better to choose one valve over the other, noted panel discussant Molly Szerlip, MD, of Baylor Scott & White The Heart Group in McKinney, Texas.
The researchers evaluated 447 patients who were receiving care at German medical centers for severe symptomatic aortic stenosis and were at an intermediate- to high-surgical risk. The patients were randomized to have the Sapien 3 valve or CoreValve Evolut R and to either receive general or local anesthesia with conscious sedation.
The individual valve strategy findings again showed equivalence without superiority between Evolut R and Sapien 3 for mortality (2.8% vs 2.3%) and moderate or severe valve regurgitation (1.9% vs 1.4%). But for stroke Evolut R came out superior (0.5% vs 4.7%), and the two didn't meet criteria for equivalence on pacemaker implantation (22.9% vs 19.0%, P=0.06 for equivalence).
"The rate of relevant valve regurgitation was low whereas permanent pacemaker rates are still relatively high," the researchers wrote.
"There may be a higher stroke rate with the balloon-expandable valve," Thiele and colleagues noted.
The anesthesia comparison endpoints all met the criteria for equivalence without superiority of general anesthesia over local anesthesia:
- Morality (2.3% vs 2.8%)
- Stroke (2.8% vs 2.4%)
- Myocardial infarction (both 0.5%)
- Infection requiring antibiotics (both 21.0%)
- Acute kidney injury (9.2% vs 8.9%)
"I am overwhelmed with these results, I think they are fantastic," said panel discussant Jeffrey Popma, MD, of Beth Israel Deaconess Medical Center in Boston. "I think it's attributed to the skill of the operators and I think that it's a testament to that there is a tremendous evolution in both of these technologies."
Notably, general anesthesia, was linked with "a higher rate of catecholamine use but does not affect procedure times, valve-related outcome, or clinical outcome," the study authors wrote.
Disclosures
The study was funded by Deutsche Herzstiftung.
Thiele did not report any disclosures.
Primary Source
Transcatheter Cardiovascular Therapeutics
Thiele H, et al "A 2x2 randomized trial of self-expandable vs balloon-expandable valves and general vs local anesthesia in patients undergoing transcatheter aortic valve implantation" TCT 2018.