Vascular complications after transcatheter aortic valve replacement: insights from the PARTNER (Placement of AoRTic TraNscathetER Valve) trial.
Publication/Presentation Date
9-18-2012
Abstract
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.
Volume
60
Issue
12
First Page
1043
Last Page
1052
ISSN
1558-3597
Published In/Presented At
Généreux, P., Webb, J. G., Svensson, L. G., Kodali, S. K., Satler, L. F., Fearon, W. F., Davidson, C. J., Eisenhauer, A. C., Makkar, R. R., Bergman, G. W., Babaliaros, V., Bavaria, J. E., Velazquez, O. C., Williams, M. R., Hueter, I., Xu, K., Leon, M. B., & PARTNER Trial Investigators (2012). Vascular complications after transcatheter aortic valve replacement: insights from the PARTNER (Placement of AoRTic TraNscathetER Valve) trial. Journal of the American College of Cardiology, 60(12), 1043–1052. https://doi.org/10.1016/j.jacc.2012.07.003
Disciplines
Medicine and Health Sciences
PubMedID
22883632
Department(s)
Department of Surgery
Document Type
Article