Transcatheter Aortic Valve Replacement in Patients With Large and Extra-Large Aortic Annuli: Hemodynamic Performance of New-Generation Balloon- and Self-Expandable Aortic Valves

German Armijo Ortiz, Gilbert Tang, Nynke Kooistra, Marina Urena, Alfredo Nunes Ferreira Neto, Stefan Toggweiler, Ignacio Amat-Santos, Hasan Ahmad, Jose Tafur Soto, Ander Regueiro, Gabriela Tirado-Conte, Angela McInerney, Mohammed Ahmed, Dominique Himbert, Fabian Nietlispach, Pieter Stella, George Dangas, Carlos Macaya, Josep Rodes-Cabau, Luis Nombela-Franco

Research output: Contribution to journalMeeting AbstractAcademic

Abstract

Background Currently, only 2 newer-generation transcatheter valves, Sapien-3 (S3) (29 mm) and Evolut-R (ER) (34 mm), are indicated for large-sized aortic annuli. We analyzed short- and mid-term performance of these valves in patients with large (area ≥575 mm2 or perimeter ≥85 mm) and extra-large (≥680 mm2 or >92.4 mm) aortic annuli undergoing transcatheter aortic valve replacement. Methods A total of 543 patients with symptomatic aortic stenosis and large aortic annulus that underwent TAVR with S3 29 mm (n = 408) and ER 34 mm (n = 135) from 12 centers were included. Clinical, anatomic, and procedural characteristics were collated, and Valve Academic Research Consortium-2 outcomes were reported. Results The mean aortic annulus area and perimeter were 623 mm2 (601.0 to 660.0 mm2) and 89.7 mm (87.4 to 92.2 mm), respectively (subgroup with extra-large annulus, area of 692 mm2 [681 to 719 mm2]). Overall device success was 77.7% (S3: 79.2% and ER: 73.3%; p = 0.158) with a 30-day mortality of 3.1%. There was a higher rate of second valve implantation and valve embolization in the ER group (3.7% vs. 0.7%; p = 0.026 and 2.2% vs. 0.2%; p = 0.049, respectively). Prosthetic valve gradient >20 mm Hg (0.8% S3 vs. 0.8% ER; p = 1.0) and aortic regurgitation (AR) ≥3 (2.0% S3 vs. 6.1% ER; p = 0.020) were low in both groups. Although major vascular and bleeding complications favored the ER group, permanent pacemaker implantation and ≥ mild paravalvular AR were lower in the S3 group. Predictors for paravalvular AR were annulus size (p = 0.001) and valve type (p = 0.011). These results remained similar in the extra-large annulus group (n = 96). Conclusion In patients with large and extra-large aortic annuli, TAVR with S3 29-mm and ER 34-mm valves is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing TAVR.
Original languageEnglish
Pages (from-to)B78-B78
JournalJournal of the American College of Cardiology
Volume74
Issue number13
Publication statusPublished - 1 Oct 2019

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