JACC. Cardiovascular interventions · 2018
The Effect of Post-Dilatation on Outcomes in the PARTNER 2 SAPIEN 3 Registry.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Hahn Rebecca T, Pibarot Philippe, Leipsic Jonathon, Blanke Philipp, Douglas Pamela S, Weissman Neil J, Kapadia Samir, Thourani Vinod H, Herrmann Howard C, Nazif Tamim, McAndrew Thomas, Webb John G, Leon Martin B, Kodali Susheel
Аннотация
OBJECTIVES: The purpose of this study was to understand the effects of balloon post-dilatation on outcomes following transcatheter aortic valve replacement with the SAPIEN 3 valve.
BACKGROUND: Hemodynamics and outcomes with balloon post-dilatation for the SAPIEN 3 valve have not been previously reported.
METHODS: The effects of balloon post-dilatation (BPD) in 1,661 intermediate (S3i cohort) and high surgical risk (S3HR cohort) patients with aortic stenosis enrolled in the PARTNER (Placement of Aortic Transcatheter Valves) 2, SAPIEN 3 observational study on outcomes, as well as procedural complications, were assessed.
RESULTS: 208 of 1,661 patients (12.5%) had BPD during the initial transcatheter aortic valve replacement. Baseline characteristics were similar except BPD had higher STS score (p < 0.001), significantly less % oversizing (p = 0.004), significantly more ≥moderate left ventricular outflow tract calcification (p = 0.005), and severe annular calcification (p = 0.006). BPD patients had no increase in permanent pacemaker, annular rupture, or valve embolization. Following transcatheter aortic valve replacement, BPD patients had significantly larger aortic valve area (1.72 ± 0.41 cm2 vs. 1.66 ± 0.37 cm2; p = 0.04) with no significant difference in prosthesis-patient mismatch (p = 0.08) or transvalvular aortic regurgitation (p = 0.65), but significantly more paravalvular regurgitation (p < 0.01). There was no significant difference in 30-day or 1-year outcomes of all-cause death (p = 0.65 to 0.76) or stroke (p = 0.28 to 0.72). However, at 1 year, there was a significantly higher incidence of minor stroke in BPD patients (p = 0.02). Adjusting for baseline differences, including calcium burden, minor strokes were no longer significantly different between the BPD and NoBPD groups (p = 0.21).
CONCLUSIONS: BPD is performed more frequently in patients with lower % oversizing and greater calcium burden. BPD is not associated with procedural complications or an increase in 1-year adverse events of death, rehospitalization, or stroke.
BACKGROUND: Hemodynamics and outcomes with balloon post-dilatation for the SAPIEN 3 valve have not been previously reported.
METHODS: The effects of balloon post-dilatation (BPD) in 1,661 intermediate (S3i cohort) and high surgical risk (S3HR cohort) patients with aortic stenosis enrolled in the PARTNER (Placement of Aortic Transcatheter Valves) 2, SAPIEN 3 observational study on outcomes, as well as procedural complications, were assessed.
RESULTS: 208 of 1,661 patients (12.5%) had BPD during the initial transcatheter aortic valve replacement. Baseline characteristics were similar except BPD had higher STS score (p < 0.001), significantly less % oversizing (p = 0.004), significantly more ≥moderate left ventricular outflow tract calcification (p = 0.005), and severe annular calcification (p = 0.006). BPD patients had no increase in permanent pacemaker, annular rupture, or valve embolization. Following transcatheter aortic valve replacement, BPD patients had significantly larger aortic valve area (1.72 ± 0.41 cm2 vs. 1.66 ± 0.37 cm2; p = 0.04) with no significant difference in prosthesis-patient mismatch (p = 0.08) or transvalvular aortic regurgitation (p = 0.65), but significantly more paravalvular regurgitation (p < 0.01). There was no significant difference in 30-day or 1-year outcomes of all-cause death (p = 0.65 to 0.76) or stroke (p = 0.28 to 0.72). However, at 1 year, there was a significantly higher incidence of minor stroke in BPD patients (p = 0.02). Adjusting for baseline differences, including calcium burden, minor strokes were no longer significantly different between the BPD and NoBPD groups (p = 0.21).
CONCLUSIONS: BPD is performed more frequently in patients with lower % oversizing and greater calcium burden. BPD is not associated with procedural complications or an increase in 1-year adverse events of death, rehospitalization, or stroke.
Предметные рубрики MeSH
AgedAged, 80 and overAortic ValveAortic Valve StenosisBalloon ValvuloplastyCalcinosisFemaleHeart Valve ProsthesisHemodynamicsHumansMaleProsthesis DesignRandomized Controlled Trials as TopicRecovery of FunctionRegistriesRetrospective StudiesRisk FactorsStrokeTime FactorsTranscatheter Aortic Valve ReplacementTreatment Outcome