Journal of the American Heart Association · 2025
Long-Term Clinical Outcomes of Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement in Patients With Small Aortic Annulus.
СтатьяСравнительное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Pawar Shubhadarshini, Patel Vivek, Nagasaka Takashi, Madaan Prateek, Jolfayi Amir Ghaffari, Koren Ofir, Patel Dhairya, Chakravarty Tarun, Nakamura Mamoo, Cheng Wen, Skaf Sabah, Jilaihawi Hasan, Makkar Raj R, Gupta Aakriti
Аннотация
BACKGROUND: Self-expanding valves (SEVs) have demonstrated superior hemodynamic performance and comparable clinical outcomes to balloon-expandable valves (BEVs) at 1 year in patients with a small aortic annulus. However, long-term data are limited. This study aimed to evaluate 5-year echocardiographic and clinical outcomes of SEVs versus BEVs in patients with small aortic annulus underwent transcatheter aortic valve replacement.
METHODS: We analyzed RESOLVE registry patients who underwent transcatheter aortic valve replacement at Cedars-Sinai between 2015 and 2020. Patients with a small aortic annulus (<430 mm2 by computed tomography) were included and followed for up to 5 years. The primary outcome was a composite of all-cause mortality, stroke, or heart failure hospitalization. Secondary outcomes included myocardial infarction, pacemaker implantation, aortic valve reintervention, and structural bioprosthetic valve dysfunction.
RESULTS: Among 1392 transcatheter aortic valve replacement recipients, 423 (78 SEVs, 345 BEVs) met the small annulus criteria. SEVs were associated with lower transvalvular gradients and larger indexed effective orifice area at discharge and 1 year (P<0.001). Moderate-to-severe paravalvular leak was more frequent with SEVs at 30 days (7.7% versus 1.5%, P<0.001), as was permanent pacemaker implantation (17.9% versus 6.1%, P<0.001). At 5 years, the primary outcome did not differ significantly (hazard ratio, 1.21; 95% CI, 0.81-1.82; P<0.33). All-cause mortality, stroke, heart failure hospitalization, structural bioprosthetic valve dysfunction, and reintervention rates were similar between groups.
CONCLUSION: Although SEVs provide better hemodynamic performance in patients with severe aortic stenosis and small annuli, this advantage did not translate into improved survival or reduced cardiovascular events at 5 years.
METHODS: We analyzed RESOLVE registry patients who underwent transcatheter aortic valve replacement at Cedars-Sinai between 2015 and 2020. Patients with a small aortic annulus (<430 mm2 by computed tomography) were included and followed for up to 5 years. The primary outcome was a composite of all-cause mortality, stroke, or heart failure hospitalization. Secondary outcomes included myocardial infarction, pacemaker implantation, aortic valve reintervention, and structural bioprosthetic valve dysfunction.
RESULTS: Among 1392 transcatheter aortic valve replacement recipients, 423 (78 SEVs, 345 BEVs) met the small annulus criteria. SEVs were associated with lower transvalvular gradients and larger indexed effective orifice area at discharge and 1 year (P<0.001). Moderate-to-severe paravalvular leak was more frequent with SEVs at 30 days (7.7% versus 1.5%, P<0.001), as was permanent pacemaker implantation (17.9% versus 6.1%, P<0.001). At 5 years, the primary outcome did not differ significantly (hazard ratio, 1.21; 95% CI, 0.81-1.82; P<0.33). All-cause mortality, stroke, heart failure hospitalization, structural bioprosthetic valve dysfunction, and reintervention rates were similar between groups.
CONCLUSION: Although SEVs provide better hemodynamic performance in patients with severe aortic stenosis and small annuli, this advantage did not translate into improved survival or reduced cardiovascular events at 5 years.
Предметные рубрики MeSH
HumansTranscatheter Aortic Valve ReplacementMaleFemaleAortic ValveAortic Valve StenosisHeart Valve ProsthesisProsthesis DesignAged, 80 and overAgedRegistriesTreatment OutcomeTime FactorsEchocardiographyHemodynamicsRetrospective StudiesFollow-Up StudiesBalloon ValvuloplastyPostoperative Complications