Outcomes and feasibility of redo‐TAVR after Sapien 3 Ultra TAVR in extremely‐undersized versus nominally‐sized annuli. Issue 6 (21st March 2022)

• Record Type: Journal Article
• Authors: Tang, Gilbert H. L.; Hooda, Amit; Zaid, Syed; Chuang, Ming‐Yu; Khera, Sahil; Krishnamoorthy, Parasuram; Lerakis, Stamatios; Anastasius, Malcolm; Ahmad, Hasan A.; Goldberg, Joshua B.; Akodad, Mariama; Wood, David A.; Leipsic, Jonathon A.; Blanke, Philipp; Dangas, George D.; Sharma, Samin K.; Kini, Annapoorna S.; Webb, John G.; Sathananthan, Janarthanan
• Is Part Of: Catheterization and cardiovascular interventions. Volume 99:Issue 6(2022)
• Page Start: 1935
• Page End: 1944
• Publication Date: 2022-03-21
• Subjects: computed tomography -- extreme annular undersizing -- redo TAVR -- Sapien 3 Ultra -- transcatheter aortic valve replacement; Heart -- Diseases -- Diagnosis -- Periodicals; Cardiac catheterization -- Periodicals; 616.1207572
• DOI: 10.1002/ccd.30146
• Languages: English
• ISSNs: 1522-1946

Abstract

Abstract: Objectives: To compare outcomes in Sapien 3 Ultra (S3U) transcatheter aortic valve replacement (TAVR) with extreme annular undersizing (EAU) versus nominal annular sizing (NAS). Background: The Edwards S3U valve has reduced paravalvular leak (PVL) in TAVR but outcomes remain unknown in extremely undersized anatomy. Implanting a smaller S3U valve may facilitate future redo‐TAVR but risk compromising hemodynamics. Methods: From December 2019 to July 2021, 366 patients with native aortic stenosis underwent S3U TAVR. Patients with EAU (annular areas >430 mm 2 for 23 mm or >546 mm 2 for 26 mm) were compared to NAS (338–430 mm 2 for 23 mm or 430–546 mm 2 for 26 mm). In‐hospital and 30‐day outcomes, and redo‐TAVR feasibility were determined. Results: There were 79 (21.6%) EAU patients, with more bicuspid ( p = 0.0014) and ≥moderate annular/left ventricular outflow tract calcification ( p < 0.001). The EAU group had less annular oversizing than NAS group (23 mm: −8.2 ± 2.6% vs. 4.0 ± 7.0%, 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 < 0.001), and postdilatation (15.0% vs. 5.8%, p = 0.016). No differences were found in in‐hospital or 30‐day mortality and stroke ( p > 0.05). Mild PVL (13.4% EAU vs. 11.5% NAS, p = 0.56) and mean gradients (23 mm: 13.0 ± 4.5 vs. 14.1 ± 5.4 mmHg, p = 0.40; 26 mm: 11.4 ± 4.1 vs. 11.5 ± 3.9 mmHg, p = 1.0) were similar at 30 days. Had the EAU group undergone NAS with the larger Sapien 3/S3U, by computed tomography analysis simulating 80:20 or 90:10 target implant depth, 33.3%–60.9% (vs. 4.3%–23.2%) would not be feasible for redo‐TAVR due to high risk of coronary obstruction. Conclusions: In this first report of EAU with S3U TAVR, similar excellent short‐term outcomes can be achieved compared to NAS, and may preserve future redo‐TAVR option.