Vascular complications after transcatheter aortic valve replacement: Insights from the PARTNER (placement of AoRTic TraNscathetER valve) trial

Philippe Généreux, John G. Webb, Lars G. Svensson, Susheel K. Kodali, Lowell F. Satler, William F. Fearon, Charles J. Davidson, Andrew C. Eisenhauer, Raj R. Makkar, Geoffrey W. Bergman, Vasilis Babaliaros, Joseph E. Bavaria, Omaida C. Velazquez, Mathew R. Williams, Irene Hueter, Ke Xu, Martin B. Leon

Research output: Contribution to journalArticle

281 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1043-1052
Number of pages10
JournalJournal of the American College of Cardiology
Volume60
Issue number12
DOIs
StatePublished - Sep 18 2012
Externally publishedYes

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Aortic Valve
Blood Vessels
Mortality
Confidence Intervals
Transcatheter Aortic Valve Replacement
Incidence
Hematoma
Renal Insufficiency
Dissection
Dialysis
Hemorrhage
Kidney

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Généreux, Philippe ; Webb, John G. ; Svensson, Lars G. ; Kodali, Susheel K. ; Satler, Lowell F. ; Fearon, William F. ; Davidson, Charles J. ; Eisenhauer, Andrew C. ; Makkar, Raj R. ; Bergman, Geoffrey W. ; Babaliaros, Vasilis ; Bavaria, Joseph E. ; Velazquez, Omaida C. ; Williams, Mathew R. ; Hueter, Irene ; Xu, Ke ; Leon, Martin B. / Vascular complications after transcatheter aortic valve replacement : Insights from the PARTNER (placement of AoRTic TraNscathetER valve) trial. In: Journal of the American College of Cardiology. 2012 ; Vol. 60, No. 12. pp. 1043-1052.
@article{ba48be1d9c8f4229a300ec659eb4ba81,
title = "Vascular complications after transcatheter aortic valve replacement: Insights from the PARTNER (placement of AoRTic TraNscathetER valve) trial",
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.",
author = "Philippe G{\'e}n{\'e}reux and Webb, {John G.} and Svensson, {Lars G.} and Kodali, {Susheel K.} and Satler, {Lowell F.} and Fearon, {William F.} and Davidson, {Charles J.} and Eisenhauer, {Andrew C.} and Makkar, {Raj R.} and Bergman, {Geoffrey W.} and Vasilis Babaliaros and Bavaria, {Joseph E.} and Velazquez, {Omaida C.} and Williams, {Mathew R.} and Irene Hueter and Ke Xu and Leon, {Martin B.}",
year = "2012",
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doi = "10.1016/j.jacc.2012.07.003",
language = "English (US)",
volume = "60",
pages = "1043--1052",
journal = "Journal of the American College of Cardiology",
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Généreux, P, Webb, JG, Svensson, LG, Kodali, SK, Satler, LF, Fearon, WF, Davidson, CJ, Eisenhauer, AC, Makkar, RR, Bergman, GW, Babaliaros, V, Bavaria, JE, Velazquez, OC, Williams, MR, Hueter, I, Xu, K & Leon, MB 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, vol. 60, no. 12, pp. 1043-1052. https://doi.org/10.1016/j.jacc.2012.07.003

Vascular complications after transcatheter aortic valve replacement : Insights from the PARTNER (placement of AoRTic TraNscathetER valve) trial. / Généreux, Philippe; Webb, John G.; Svensson, Lars G.; Kodali, Susheel K.; Satler, Lowell F.; Fearon, William F.; Davidson, Charles J.; Eisenhauer, Andrew C.; Makkar, Raj R.; Bergman, Geoffrey W.; Babaliaros, Vasilis; Bavaria, Joseph E.; Velazquez, Omaida C.; Williams, Mathew R.; Hueter, Irene; Xu, Ke; Leon, Martin B.

In: Journal of the American College of Cardiology, Vol. 60, No. 12, 18.09.2012, p. 1043-1052.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Vascular complications after transcatheter aortic valve replacement

T2 - Insights from the PARTNER (placement of AoRTic TraNscathetER valve) trial

AU - Généreux, Philippe

AU - Webb, John G.

AU - Svensson, Lars G.

AU - Kodali, Susheel K.

AU - Satler, Lowell F.

AU - Fearon, William F.

AU - Davidson, Charles J.

AU - Eisenhauer, Andrew C.

AU - Makkar, Raj R.

AU - Bergman, Geoffrey W.

AU - Babaliaros, Vasilis

AU - Bavaria, Joseph E.

AU - Velazquez, Omaida C.

AU - Williams, Mathew R.

AU - Hueter, Irene

AU - Xu, Ke

AU - Leon, Martin B.

PY - 2012/9/18

Y1 - 2012/9/18

N2 - 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.

AB - 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.

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