Feasibility and Outcomes of 29 mm Edwards SAPIEN 3 Valve in Aortic Annular Area >683 mm²: A Case Series

Background and aim of the study: The Edwards SAPIEN 3 (S3) 29 mm valve has been used for transcatheter aortic valve replacement (TAVR) with good results in patients with aortic annular areas up to 683 mm2, in accordance with FDA recommendations. These recommendations for TAVR have been followed closely, as they were thought to minimize perivalvular leak, with good results. Currently, very little information is available regarding the outcomes of TAVR in larger than FDA-recommended annular areas.

Methods: All 29 mm valve recipients at the authors’ center over the past three years were reviewed retrospectively, and only patients with aortic annular areas >683 mm2 were included. Of 116 patients, only three met the inclusion criteria, and were assessed for outcomes after TAVR, such as valve hemodynamics, acute kidney injury, new-onset atrial fibrillation, new pacemaker implantation, stroke, and prolonged intensive care unit stay.

Results: All three patients had trace to no perivalvular leak on two-dimensional echocardiography after TAVR, with marked improvements in their aortic valve gradients and overall valve hemodynamics. The patients’ clinical symptoms improved significantly, and they were discharged after a short hospital course. There were no major complications associated with the procedure, despite their large annular size, older age, and frailty.

Conclusion: The outcomes of TAVR with 29 mm S3 valves in larger than the accepted norm of aortic annulus were optimal in three patients. These results were consistent with a good outcome in larger annular diameters when placed appropriately and oversized systematically. These points should be considered when sizing valves for larger annular diameters.

The Journal of Heart Valve Disease 2018-19;28:8-13