Clinical and Echocardiographic Outcomes of SAPIEN 3 Ultra TAVR in Extremely Undersized versus Nominally Sized Annuli

Author Type(s)

Faculty

Document Type

Abstract

Publication Date

11-2021

Journal Title

Journal of the American College of Cardiology

Department

Surgery

Second Department

Medicine

Abstract

Background

The latest generation Edwards SAPIEN 3 Ultra (S3U) valve has reduced paravalvular leak (PVL) in transcatheter aortic valve replacement (TAVR), but outcomes remain unknown in extremely undersized anatomy. Implanting a smaller S3U valve may facilitate future transcatheter aortic valve (TAV)–in–TAV but risks compromising hemodynamic status. We sought to compare outcomes of S3U TAVR in patients with extremely annular undersizing (EAU) versus nominal annular sizing (NAS).

Methods

From December 2019 to July 2021, 337 patients from 3 centers with native aortic stenosis underwent S3U TAVR. Patients with EAU beyond manufacturer recommendation (annular area > 430 mm2 for the 23-mm S3U and >546 mm2 for the 26-mm S3U) were compared with those who had NAS (annular area 338-430 mm2 for the 23-mm S3U and 430-546 mm2 for the 26-mm S3U). In-hospital and 30-day outcomes per Valve Academic Research Consortium-3 definitions were determined.

Results

There were 80 patients with EAU (23.7%), with more bicuspid (P = 0.0014) and moderate or greater annular or left ventricular outflow tract calcification (P < 0.0001) (Figure 1). The EAU group had less annular oversizing than the NAS group (23 mm, −8.2% ± 2.6% vs 4.4% ± 7.2% [P < 0.001]; 26 mm, −8.9% ± 2.2% vs 6.7% ± 6.9% [P < 0.001]), more balloon overfilling (71.3% vs 11.6%; P < 0.0001), and more postdilatation (15.0% vs 5.8%; P = 0.016). No differences were found in in-hospital or 30-day mortality or stroke and pacemaker rates (P > 0.05). Mild PVL (5.0% in the EAU group vs 5.8% in the NAS group; P = 1.00) and mean gradients (23 mm, 12.9 ± 5.0 mm Hg vs 13.8 ± 5.3 mm Hg [P = 0.40]; 26 mm, 10.7 ± 4.1 mm Hg vs 11.1 ± 4.0 mm Hg [P = 0.54]) were similar at 30 days. Had the EAU group undergone NAS with the larger S3U, by virtual computed tomographic analysis, 43.1% may not have been anatomically feasible for TAVR-in-TAVR because of moderate to high risk for coronary obstruction.

Conclusion

In this first report of extreme annular undersizing with S3U TAVR in select anatomies, similar excellent short-term outcomes were achieved compared with NAS and may preserve potential TAV-in-TAV in the future.

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