TY - JOUR
T1 - Outcomes and feasibility of redo-TAVR after Sapien 3 Ultra TAVR in extremely-undersized versus nominally-sized annuli
AU - Tang, Gilbert H.L.
AU - Hooda, Amit
AU - Zaid, Syed
AU - Chuang, Ming Yu
AU - Khera, Sahil
AU - Krishnamoorthy, Parasuram
AU - Lerakis, Stamatios
AU - Anastasius, Malcolm
AU - Ahmad, Hasan A.
AU - Goldberg, Joshua B.
AU - Akodad, Mariama
AU - Wood, David A.
AU - Leipsic, Jonathon A.
AU - Blanke, Philipp
AU - Dangas, George D.
AU - Sharma, Samin K.
AU - Kini, Annapoorna S.
AU - Webb, John G.
AU - Sathananthan, Janarthanan
N1 - Funding Information:
Dr. Gilbert H. L. Tang is a physician proctor for Medtronic, a consultant for Medtronic, Abbott Structural Heart, Neochord, and a physician advisory board member for Abbott and JenaValve. Dr. Sahil Khera is a physician proctor and consultant for Medtronic and a consultant for Abbott, Boston Scientific, and Terumo. Dr. David A. Wood is a consultant to, and has received research funding from Edwards Lifesciences and Abbott. Dr. Jonathon A. Leipsic is a consultant to MVRX and CIRCLE CVI and institutional core lab contracts with Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, PI Cardia, and Neovasc. Dr. Philipp Blanke is a consultant to Edwards Lifesciences, Abbott, Neovasc, and Circle Cardiovascular Imaging. Dr. Samin K. Sharma receives honoraria for the Speaker's Bureau from Abbott Vascular, Boston Scientific, and Cardiovascular Systems Inc. Dr. John G. Webb is a consultant to, and has received research funding from Edwards Lifesciences, Abbott, and ViVitro Labs. Dr. Janarthanan Sathananthan is a consultant to Edwards Lifesciences, Medtronic, and Boston Scientific. He has received speaking fees from New Valve Technologies. He has received research funding from Medtronic and Edwards Lifesciences. The remaining authors declare no conflicts of interest.
Publisher Copyright:
© 2022 Wiley Periodicals LLC.
PY - 2022/5/1
Y1 - 2022/5/1
N2 - 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 mm2 for 23 mm or >546 mm2 for 26 mm) were compared to NAS (338–430 mm2 for 23 mm or 430–546 mm2 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.
AB - 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 mm2 for 23 mm or >546 mm2 for 26 mm) were compared to NAS (338–430 mm2 for 23 mm or 430–546 mm2 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.
KW - Sapien 3 Ultra
KW - computed tomography
KW - extreme annular undersizing
KW - redo TAVR
KW - transcatheter aortic valve replacement
UR - http://www.scopus.com/inward/record.url?scp=85127202605&partnerID=8YFLogxK
U2 - 10.1002/ccd.30146
DO - 10.1002/ccd.30146
M3 - Article
C2 - 35312218
AN - SCOPUS:85127202605
VL - 99
SP - 1935
EP - 1944
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
SN - 1522-1946
IS - 6
ER -