SAN DIEGO — General and local anesthesia are comparably safe and effective during transcatheter aortic valve replacement (TAVR) procedures, according to the first randomized trial to compare the two approaches.
SOLVE-TAVI was a 2x2 randomized trial evaluating the anesthesia strategies, along with current generations of a balloon-expandable valve (Sapien 3, Edwards Lifesciences) and a self-expanding valve (CoreValve Evolut R, Medtronic). The main takeaway from the trial, presented at the Transcatheter Cardiovascular Therapeutics meeting on Sunday, Sept. 23, was that neither the type of valve nor the anesthesia approach had much of an impact on outcomes at 30 days.
According to presenting author Holger Thiele, MD, registry data indicates about half of TAVR procedures are performed with local anesthesia and conscious sedation. This technique has been associated with reduced stays in intensive care units and the hospital overall, representing an opportunity to lower healthcare costs. However, it had never previously been evaluated against general anesthesia in a randomized trial.
In studying about 220 patients randomized to each approach, Thiele et al. found 27 percent of the local anesthesia group and 25.5 percent of the general anesthesia group met the primary endpoint at 30 days—a composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment and acute kidney injury. Those percentages were primarily tied to infections requiring antibiotics—21 percent in each group.
General anesthesia was linked to a higher rate of catecholamine use but didn’t affect procedure times, valve outcomes or clinical outcomes.
“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,” said Thiele, director of the Heart Center Leipzig in Leipzig, Germany, noting that local anesthesia could be a key component of ‘minimalist TAVR’ procedures designed to reduce costs and shorten hospital stays.
During a press conference when the results were presented, Molly Szerlip, MD, an interventional cardiologist at The Heart Hospital Baylor Plano in Texas, said convincing anesthesiologists of the merits of conscious sedation is a crucial step to broader implementation of this potentially cost-saving measure.
“Here in the U.S. a lot of the reason why we use general anesthesia, too, is because it’s the preference of the anesthesiologist and it’s just a battle that is not waged,” she said. “But maybe this (study) will also give more validity to the fact that you can do both. I know at our institution the anesthesiologists now prefer to do conscious sedation, so it’s just sort of a paradigm shift that you have to get used to.”
In studying the outcomes related to valve types, Thiele et al. used a 30-day composite endpoint of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation and permanent pacemaker implantation. They found the endpoint was met in 27.2 percent of the Evolut R group and 26.1 percent of Sapien 3 patients, a nonsignificant difference. Pacemaker implantation accounted for roughly 20 percent of the endpoint occurrences in each group, while the only component with a statistically significant difference was stroke (4.7 percent for Sapien 3; 0.5 percent for Evolut R).
Multiple panelists said self-expanding valves may be the preferred option for small annuli or calcified aortic valves, but in most cases the valve type doesn’t matter.
Michael J. Mack, MD, also with The Heart Hospital Baylor Plano, used the analogy of a Venn diagram with a large overlapping section to define how heart teams should view valve decisions.
“There’s 10 percent on one side where self-expanding valves are clearly optimal and on the other end 10 percent where balloon-expandable is optimal, and I think this study totally reinforces that—that for 80 percent of patients one valve or the other is probably fine and therefore it’s left to the experience of the institution with a particular valve, the comfort level of the operator with a particular valve and then the decision-making within the institutions as to whether the particulars of the patient … would benefit from one versus the other,” Mack said.