Transcatheter Aortic Valve Replacement in Patients With Small Aortic Annulus: An Observational Study

Background: The Small Annuli Randomized to Evolut or SAPIEN Trial showed superior hemodynamics of self-expanding valves (SEVs) over balloon-expandable valves (BEVs) in patients with small aortic annuli (SAA). The long-term clinical implications of these hemodynamic differences are unknown. Methods:...

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Main Authors: Hanad Bashir, MD, Christian W. Schmidt, MS, Kofi Ansah, MD, Gustavo Mendez-Hirata, MD, Geoffrey A. Answini, MD, J. Michael Smith, MD, Saad Hasan, MD, Jeffrey Griffin, MD, Robert Dowling, MD, Dean J. Kereiakes, MD, Puvi Seshiah, MD, Joseph Choo, MD, Zaid Alirhayim, MD, Santiago Garcia, MD
Format: Article
Language:English
Published: Elsevier 2025-02-01
Series:Structural Heart
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Online Access:http://www.sciencedirect.com/science/article/pii/S2474870624000861
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Summary:Background: The Small Annuli Randomized to Evolut or SAPIEN Trial showed superior hemodynamics of self-expanding valves (SEVs) over balloon-expandable valves (BEVs) in patients with small aortic annuli (SAA). The long-term clinical implications of these hemodynamic differences are unknown. Methods: We conducted an observational cohort study of patients with SAA, defined as an aortic valve annular area ≤430 mm2 on cardiac computed tomography, who underwent transcatheter aortic valve replacement using BEV or SEV at a single institution between August 2013 and February 2021. Patients undergoing valve-in-valve procedures or alternative access were excluded. Patient-prosthesis mismatch (PPM) was defined as moderate when indexed effective orifice area of 0.65-0.85 cm2/m2 and severe when indexed effective orifice area was <0.65 cm2/m2 (or <0.55 cm2/m2 for body mass index >30 kg/m2). The primary outcome of the study was mortality and major adverse cardiovascular events. Results: A total of 258 patients were included. The majority were female (81%) with intermediate surgical risk (median STS risk score 4.23); 90 patients (35%) received a BEV (median age 80 years [73, 86]) and 168 (65%) received a SEV (81 years [75, 85], p = 0.699). Comorbidities and risk profiles were well balanced between groups. At 30 days post-transcatheter aortic valve replacement, SEV had lower aortic valve mean gradients (8 mmHg [6, 11] vs. BEV 14 mmHg [10, 18], p < 0.001), lower peak velocities (1.86 m/s [1.60, 2.34] vs. BEV 2.52 m/s [2.14, 2.90], p < 0.001), and were less likely to have PPM (SEV 18% vs. BEV 42% (p < 0.001). At 3 years, both groups had similar mortality (SEV 23% vs. BEV 22%, p = 0.875). PPM was not associated with long-term mortality. Conclusions: In patients with SAA, we observed no difference in mortality between SEV and BEV up to 3 years after the index procedure, despite early differences in valve hemodynamics.
ISSN:2474-8706