April 22, 2026
Ver artículo completoVascular Complications After Transcatheter Aortic Valve Replacement
Resultado clave
Major vascular complications occurred in 15.3% of patients after transfemoral TAVR and independently predicted 1-year mortality (HR 2.31; 95% CI 1.20-4.43; p=0.012).
Puntos clave
- The study aims to identify the incidence, predictors, and impact of vascular complications following transfemoral transcatheter aortic valve replacement.
- Randomized controlled trial using data from the PARTNER trial with 419 patients assigned to transfemoral TAVR.
- Evaluated 30-day rates of major and minor vascular complications and assessed their impact on 1-year mortality.
- Utilized first-generation Edwards-Sapien valves and delivery systems via a 22- or 24-F sheath.
- Fifteen point three percent (15.3%) of patients had major vascular complications, and eleven point nine percent (11.9%) had minor vascular complications within 30 days.
- Only female gender was identified as an independent predictor of major vascular complications (HR: 2.31, 95% CI: 1.08 to 4.98, p = 0.03).
- Major vascular complications were linked to higher rates of major bleeding, renal failure, and increased mortality at 30 days and 1 year (HR: 2.31, p = 0.012).
Diseño del estudio
Tipo
RCT (n=419)
Aleatorización
Randomized
PICO estructurado
P
Población
419 patients from the PARTNER trial (177 inoperable [cohort B] and 242 operable high-risk [cohort A]) who were randomly assigned to and received transfemoral transcatheter aortic valve replacement (TF-TAVR)
I
Intervención
Transfemoral transcatheter aortic valve replacement (TF-TAVR) using first-generation Edwards-Sapien valves and delivery systems via a 22- or 24-F sheath
O
Resultado
30-day rates of major and minor vascular complications (modified Valve Academic Research Consortium definitions), predictors, and effect on 1-year mortalitysafety
Major vascular complications are frequent after transfemoral TAVR with first-generation devices and are independently associated with increased 1-year mortality.
Resultado numérico
Estimación del efecto: HR 2.31 (95% CI 1.20-4.43)
valor p: p=0.012
Resumen
OBJECTIVES: This study sought to identify incidence, predictors, and impact of vascular complications (VC) after transfemoral (TF) transcatheter aortic valve replacement (TAVR). BACKGROUND: VC after TF-TAVR are frequent and may be associated with unfavorable prognosis. METHODS: From the randomized controlled PARTNER (Placement of AoRTic TraNscathetER Valve) trial, a total of 419 patients (177 from cohort B inoperable and 242 from cohort A operable high-risk) were randomly assigned to TF-TAVR and actually received the designated treatment. First-generation Edwards-Sapien valves and delivery systems were used, via a 22- or 24-F sheath. The 30-day rates of major and minor VC (modified Valve Academic Research Consortium definitions), predictors, and effect on 1-year mortality were assessed. RESULTS: Sixty-four patients (15.3%) had major VC and 50 patients (11.9%) had minor VC within 30 days of the procedure. Among patients with major VC, vascular dissection (62.8%), perforation (31.3%), and access-site hematoma (22.9%) were the most frequent modes of presentation. Major VC, but not minor VC, were associated with significantly higher 30-day rates of major bleeding, transfusions, and renal failure requiring dialysis, and with a significantly higher rate of 30-day and 1-year mortality. The only identifiable independent predictor of major VC was female gender (hazard ratio HR: 2.31 95% confidence interval (CI): 1.08 to 4.98, p = 0.03). Major VC (HR: 2.31 95% CI: 1.20 to 4.43, p = 0.012), and renal disease at baseline (HR: 2.26 95% CI: 1.34 to 3.81, p = 0.002) were identified as independent predictors of 1-year mortality. CONCLUSIONS: Major VC were frequent after TF-TAVR in the PARTNER trial using first-generation devices and were associated with high mortality. However, the incidence and impact of major VC on 1-year mortality decreased with lower-risk populations.
Expert Takes4 quotes
1/4
“The improvement was partly due to better patient selection, partly better techniques, partly smaller catheters, and maybe a little luck. All were important.”