SOLVE-TAVI trial results comparing self-expanding valves with balloon-expandable valves, as well as general vs. local anesthesia, in patients undergoing transcatheter aortic valve replacement (TAVR) build on the currently limited evidence for direct comparisons of latest generation valve designs and anesthesia strategies, said researchers presenting at TCT 2018.

The two-pronged trial randomized symptomatic aortic stenosis patients undergoing transfemoral TAVR to either the self-expanding CoreValve Evolut R (N=225) or the balloon-expandable Edwards Sapien 3 (N=222), as well as to local anesthesia (N=222) or general anesthesia (N=225).

In presenting the results, Holger Thiele, MD, said the Corevalve Evolut R was shown to be equivalent to the Edwards Sapien 3 with respect to the composite of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days. Permanent pacemaker implantation rates were higher in both groups (22.9 percent in Evolut R group and 19.0 percent in Sapien 3 group). Thiele and colleagues also noted the potential for a higher stroke rate with the balloon-expandable valve.

In terms of anesthesia strategy, local anesthesia with conscious sedation was found to be equivalent to general anesthesia with respect to the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment and acute kidney injury. Researchers also noted general anesthesia was associated with a higher rate of catecholamine use but did not affect procedure times, valve-related outcomes or clinical outcomes.

Thiele, et al., note that registry data to date has suggested lower mortality and morbidity, shorter ICU and hospitals stays, as well as shorter procedure times, with local anesthesia. The SOLVE-TAVI findings add to the limited clinical trial research currently available regarding safety and efficacy.

Keywords: TCT18, Transcatheter Cardiovascular Therapeutics, Angiography, Percutaneous Coronary Intervention, Transcatheter Aortic Valve Replacement, Anesthesia, Local, Aortic Valve, Heart Valve Prosthesis

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