Incidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement

Philippe Genereux, David J. Cohen, Michael Mack, Josep Rodes-Cabau, Mayank Yadav, Ke Xu, Rupa Parvataneni, Rebecca Hahn, Susheel K. Kodali, John G. Webb, Martin B. Leon

Research output: Contribution to journalArticle

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Abstract

Background The incidence and prognostic impact of late bleeding complications after transcatheter aortic valve replacement (TAVR) are unknown.

Objectives The aim of this study was to identify the incidence, predictors, and prognostic impact of major late bleeding complications (MLBCs) (≥30 days) after TAVR.

Methods Clinical and echocardiographic outcomes of patients who underwent TAVR within the randomized cohorts and continued access registries in the PARTNER (Placement of Aortic Transcatheter Valves) trial were analyzed after stratifying by the occurrence of MLBCs. Predictors of MLBCs and their association with 30-day to 1-year mortality were assessed.

Results Among 2,401 patients who underwent TAVR and survived to 30 days, MLBCs occurred in 142 (5.9%) at a median time of 132 days (interquartile range: 71 to 230 days) after the index procedure. Gastrointestinal complications (n = 58 [40.8%]), neurological complications (n = 22 [15.5%]), and traumatic falls (n = 11 [7.8%]) were identified as the most frequent types of MLBCs. Independent predictors of MLBCs were the presence of low hemoglobin at baseline, atrial fibrillation or flutter at baseline or 30 days, the presence of moderate or severe paravalvular leak at 30 days, and greater left ventricular mass at 30 days. MLBCs were identified as a strong independent predictor of mortality between 30 days and 1 year (adjusted hazard ratio: 3.91; 95% confidence interval: 2.67 to 5.71; p < 0.001).

Conclusions MLBCs after TAVR were frequent and associated with increased mortality. Better individualized and risk-adjusted antithrombotic therapy after TAVR is urgently needed in this high-risk population. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

Original languageEnglish (US)
Pages (from-to)2605-2615
Number of pages11
JournalJournal of the American College of Cardiology
Volume64
Issue number24
DOIs
StatePublished - Dec 23 2014
Externally publishedYes

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Hemorrhage
Incidence
Aortic Valve
Mortality
Transcatheter Aortic Valve Replacement
Atrial Flutter
Atrial Fibrillation
Registries
Hemoglobins
Confidence Intervals
Population

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Genereux, Philippe ; Cohen, David J. ; Mack, Michael ; Rodes-Cabau, Josep ; Yadav, Mayank ; Xu, Ke ; Parvataneni, Rupa ; Hahn, Rebecca ; Kodali, Susheel K. ; Webb, John G. ; Leon, Martin B. / Incidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement. In: Journal of the American College of Cardiology. 2014 ; Vol. 64, No. 24. pp. 2605-2615.
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title = "Incidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement",
abstract = "Background The incidence and prognostic impact of late bleeding complications after transcatheter aortic valve replacement (TAVR) are unknown.Objectives The aim of this study was to identify the incidence, predictors, and prognostic impact of major late bleeding complications (MLBCs) (≥30 days) after TAVR.Methods Clinical and echocardiographic outcomes of patients who underwent TAVR within the randomized cohorts and continued access registries in the PARTNER (Placement of Aortic Transcatheter Valves) trial were analyzed after stratifying by the occurrence of MLBCs. Predictors of MLBCs and their association with 30-day to 1-year mortality were assessed.Results Among 2,401 patients who underwent TAVR and survived to 30 days, MLBCs occurred in 142 (5.9{\%}) at a median time of 132 days (interquartile range: 71 to 230 days) after the index procedure. Gastrointestinal complications (n = 58 [40.8{\%}]), neurological complications (n = 22 [15.5{\%}]), and traumatic falls (n = 11 [7.8{\%}]) were identified as the most frequent types of MLBCs. Independent predictors of MLBCs were the presence of low hemoglobin at baseline, atrial fibrillation or flutter at baseline or 30 days, the presence of moderate or severe paravalvular leak at 30 days, and greater left ventricular mass at 30 days. MLBCs were identified as a strong independent predictor of mortality between 30 days and 1 year (adjusted hazard ratio: 3.91; 95{\%} confidence interval: 2.67 to 5.71; p < 0.001).Conclusions MLBCs after TAVR were frequent and associated with increased mortality. Better individualized and risk-adjusted antithrombotic therapy after TAVR is urgently needed in this high-risk population. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).",
author = "Philippe Genereux and Cohen, {David J.} and Michael Mack and Josep Rodes-Cabau and Mayank Yadav and Ke Xu and Rupa Parvataneni and Rebecca Hahn and Kodali, {Susheel K.} and Webb, {John G.} and Leon, {Martin B.}",
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Genereux, P, Cohen, DJ, Mack, M, Rodes-Cabau, J, Yadav, M, Xu, K, Parvataneni, R, Hahn, R, Kodali, SK, Webb, JG & Leon, MB 2014, 'Incidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement', Journal of the American College of Cardiology, vol. 64, no. 24, pp. 2605-2615. https://doi.org/10.1016/j.jacc.2014.08.052

Incidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement. / Genereux, Philippe; Cohen, David J.; Mack, Michael; Rodes-Cabau, Josep; Yadav, Mayank; Xu, Ke; Parvataneni, Rupa; Hahn, Rebecca; Kodali, Susheel K.; Webb, John G.; Leon, Martin B.

In: Journal of the American College of Cardiology, Vol. 64, No. 24, 23.12.2014, p. 2605-2615.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Incidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement

AU - Genereux, Philippe

AU - Cohen, David J.

AU - Mack, Michael

AU - Rodes-Cabau, Josep

AU - Yadav, Mayank

AU - Xu, Ke

AU - Parvataneni, Rupa

AU - Hahn, Rebecca

AU - Kodali, Susheel K.

AU - Webb, John G.

AU - Leon, Martin B.

PY - 2014/12/23

Y1 - 2014/12/23

N2 - Background The incidence and prognostic impact of late bleeding complications after transcatheter aortic valve replacement (TAVR) are unknown.Objectives The aim of this study was to identify the incidence, predictors, and prognostic impact of major late bleeding complications (MLBCs) (≥30 days) after TAVR.Methods Clinical and echocardiographic outcomes of patients who underwent TAVR within the randomized cohorts and continued access registries in the PARTNER (Placement of Aortic Transcatheter Valves) trial were analyzed after stratifying by the occurrence of MLBCs. Predictors of MLBCs and their association with 30-day to 1-year mortality were assessed.Results Among 2,401 patients who underwent TAVR and survived to 30 days, MLBCs occurred in 142 (5.9%) at a median time of 132 days (interquartile range: 71 to 230 days) after the index procedure. Gastrointestinal complications (n = 58 [40.8%]), neurological complications (n = 22 [15.5%]), and traumatic falls (n = 11 [7.8%]) were identified as the most frequent types of MLBCs. Independent predictors of MLBCs were the presence of low hemoglobin at baseline, atrial fibrillation or flutter at baseline or 30 days, the presence of moderate or severe paravalvular leak at 30 days, and greater left ventricular mass at 30 days. MLBCs were identified as a strong independent predictor of mortality between 30 days and 1 year (adjusted hazard ratio: 3.91; 95% confidence interval: 2.67 to 5.71; p < 0.001).Conclusions MLBCs after TAVR were frequent and associated with increased mortality. Better individualized and risk-adjusted antithrombotic therapy after TAVR is urgently needed in this high-risk population. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

AB - Background The incidence and prognostic impact of late bleeding complications after transcatheter aortic valve replacement (TAVR) are unknown.Objectives The aim of this study was to identify the incidence, predictors, and prognostic impact of major late bleeding complications (MLBCs) (≥30 days) after TAVR.Methods Clinical and echocardiographic outcomes of patients who underwent TAVR within the randomized cohorts and continued access registries in the PARTNER (Placement of Aortic Transcatheter Valves) trial were analyzed after stratifying by the occurrence of MLBCs. Predictors of MLBCs and their association with 30-day to 1-year mortality were assessed.Results Among 2,401 patients who underwent TAVR and survived to 30 days, MLBCs occurred in 142 (5.9%) at a median time of 132 days (interquartile range: 71 to 230 days) after the index procedure. Gastrointestinal complications (n = 58 [40.8%]), neurological complications (n = 22 [15.5%]), and traumatic falls (n = 11 [7.8%]) were identified as the most frequent types of MLBCs. Independent predictors of MLBCs were the presence of low hemoglobin at baseline, atrial fibrillation or flutter at baseline or 30 days, the presence of moderate or severe paravalvular leak at 30 days, and greater left ventricular mass at 30 days. MLBCs were identified as a strong independent predictor of mortality between 30 days and 1 year (adjusted hazard ratio: 3.91; 95% confidence interval: 2.67 to 5.71; p < 0.001).Conclusions MLBCs after TAVR were frequent and associated with increased mortality. Better individualized and risk-adjusted antithrombotic therapy after TAVR is urgently needed in this high-risk population. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

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DO - 10.1016/j.jacc.2014.08.052

M3 - Article

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SP - 2605

EP - 2615

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

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