Incidence, Predictors, and Prognostic Impact of Bleeding Events After TAVR According to VARC-3 Criteria.
TAVR
VARC-3 criteria
bleeding
transcatheter aortic valve replacement
Journal
JACC. Cardiovascular interventions
ISSN: 1876-7605
Titre abrégé: JACC Cardiovasc Interv
Pays: United States
ID NLM: 101467004
Informations de publication
Date de publication:
25 09 2023
25 09 2023
Historique:
received:
01
05
2023
revised:
05
07
2023
accepted:
11
07
2023
medline:
29
9
2023
pubmed:
7
9
2023
entrez:
7
9
2023
Statut:
ppublish
Résumé
The updated Valve Academic Research Consortium (VARC) definition for bleeding events after transcatheter aortic valve replacement (TAVR) lacks of clinical validation. The aim of this study was to determine the incidence, predictors, and clinical impact of bleeding events following TAVR as defined by recent VARC-3 criteria. A total of 2,384 consecutive patients with severe symptomatic aortic stenosis undergoing TAVR were included. Early (at index hospitalization) and late (after hospital discharge) bleeding complications were defined according to VARC-3 criteria as type 1, 2, 3, or 4. Baseline, procedural, and follow-up (24 [IQR: 12-43] months) data were prospectively collected. Bleeding events occurred in 761 patients (31.9%): types 1, 2, 3, and 4 in 169 (22.2%), 399 (52.4%), 149 (19.6%), and 44 (5.8%) patients, respectively. The primary vascular access site and gastrointestinal locations were the most common bleeding sources among early and late bleeding events, respectively. Female sex, thoracotomy access, larger (14-F) sheath use, and dual antiplatelet therapy determined an increased risk of early bleeding events (P < 0.02 for all). The use of the radial artery for secondary access was associated with a significant risk reduction of early bleeding (P < 0.001). Type 2 and type 3 events were associated with an increased mortality risk at 30-day (HR: 2.94 [95% CI: 1.43-6.03; P = 0.003] and HR: 4.91 [95% CI: 2.19-11.03; P < 0.001], respectively) and 1-year (HR: 1.86 [95% CI: 1.28-2.69; P = 0.001] and HR: 2.28 [95% CI: 1.41-3.66; P = 0.001], respectively) follow-up. A similar prognostic pattern was observed when applying VARC-2 criteria but with a much lower global incidence of early bleeding events (19% vs 27%; P < 0.001). Bleeding events after TAVR were associated with poorer short- and long-term survival. The magnitude of this correlation was proportional to bleeding severity defined according to VARC-3 criteria. Further studies on bleeding prevention following TAVR are warranted to improve procedural safety and patient prognosis.
Sections du résumé
BACKGROUND
The updated Valve Academic Research Consortium (VARC) definition for bleeding events after transcatheter aortic valve replacement (TAVR) lacks of clinical validation.
OBJECTIVES
The aim of this study was to determine the incidence, predictors, and clinical impact of bleeding events following TAVR as defined by recent VARC-3 criteria.
METHODS
A total of 2,384 consecutive patients with severe symptomatic aortic stenosis undergoing TAVR were included. Early (at index hospitalization) and late (after hospital discharge) bleeding complications were defined according to VARC-3 criteria as type 1, 2, 3, or 4. Baseline, procedural, and follow-up (24 [IQR: 12-43] months) data were prospectively collected.
RESULTS
Bleeding events occurred in 761 patients (31.9%): types 1, 2, 3, and 4 in 169 (22.2%), 399 (52.4%), 149 (19.6%), and 44 (5.8%) patients, respectively. The primary vascular access site and gastrointestinal locations were the most common bleeding sources among early and late bleeding events, respectively. Female sex, thoracotomy access, larger (14-F) sheath use, and dual antiplatelet therapy determined an increased risk of early bleeding events (P < 0.02 for all). The use of the radial artery for secondary access was associated with a significant risk reduction of early bleeding (P < 0.001). Type 2 and type 3 events were associated with an increased mortality risk at 30-day (HR: 2.94 [95% CI: 1.43-6.03; P = 0.003] and HR: 4.91 [95% CI: 2.19-11.03; P < 0.001], respectively) and 1-year (HR: 1.86 [95% CI: 1.28-2.69; P = 0.001] and HR: 2.28 [95% CI: 1.41-3.66; P = 0.001], respectively) follow-up. A similar prognostic pattern was observed when applying VARC-2 criteria but with a much lower global incidence of early bleeding events (19% vs 27%; P < 0.001).
CONCLUSIONS
Bleeding events after TAVR were associated with poorer short- and long-term survival. The magnitude of this correlation was proportional to bleeding severity defined according to VARC-3 criteria. Further studies on bleeding prevention following TAVR are warranted to improve procedural safety and patient prognosis.
Identifiants
pubmed: 37676226
pii: S1936-8798(23)01045-2
doi: 10.1016/j.jcin.2023.07.005
pii:
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2262-2274Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Funding Support and Author Disclosures Dr Real is supported by the Fundacion Interhospitalaria Para la Investigación Cardiovascular (Madrid, Spain). Dr Nuche is a recipient of a grant from Fundación Alfonso Martín Escudero (Madrid, Spain). Dr Rodés-Cabau has received institutional research grants and speaker and consultant fees from Edwards Lifesciences and Medtronic, and holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions (Laval University, Quebec City, Canada). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.