Successfully Managed Access-Site Complication Was Not Associated With Worse Outcome After Percutaneous Transfemoral Transcatheter Aortic Valve Implantation: Up-to-Date Insights From the OCEAN-TAVI Registry.
Access-site complications
Bail-out procedure
Prognosis
Transfemoral transcatheter aortic valve implantation
Journal
Cardiovascular revascularization medicine : including molecular interventions
ISSN: 1878-0938
Titre abrégé: Cardiovasc Revasc Med
Pays: United States
ID NLM: 101238551
Informations de publication
Date de publication:
05 2022
05 2022
Historique:
received:
27
05
2021
revised:
21
07
2021
accepted:
04
08
2021
pubmed:
16
8
2021
medline:
12
5
2022
entrez:
15
8
2021
Statut:
ppublish
Résumé
Access-site complications during transfemoral transcatheter aortic valve implantation (TF-TAVI) cause serious issues in the future, if unresolved, but the best strategies to manage these complications remains unclear. This study aimed to comprehensively assess access-site complications during percutaneous TF-TAVI in terms of their management. Using the prospective, multicentre, observational registry OCEAN (Optimized Transcatheter Valvular Intervention), 1497 patients who underwent percutaneous TF-TAVI between October 2013 and May 2017 were identified. The incidence, predictors, temporal changes, and prognosis of access-site complications along with its treatment strategy and re-intervention rate were evaluated. Access-site complications occurred in 105 patients (7.0%) and was predicted with lower body-mass-index (OR, 0.94; 95% CI; 0.89-0.99; p = 0.03) and higher sheath-to-femoral-artery-ratio (OR, 1.12; 95% CI, 1.03-1.24; p < 0.002). The incidence of access-site complications declined over time, irrespective of the increasing number of percutaneous TF-TAVI cases. Access-site complications were treated by conservative therapy (n = 19, 18%), interventional procedures (n = 42, 40%), rescue surgical repair (SR) (n = 10, 10%), and primary SR (n = 34, 32%). The severity of complications differed but the re-intervention rate was similar among 4 groups (p = 0.46). Re-intervention was not needed, except for a case of common femoral artery stenosis/occlusion induced by ProGlide. The need for all SRs decreased annually. Access-site complications were not associated with 30 days- and 1 year-survival rate. The incidence of access-site complications was not low but has declined annually. Access-site complications are not related to worse outcomes after successful management. Interventional procedure is acceptable as the first-line strategy to treat access-site complications.
Sections du résumé
BACKGROUND
Access-site complications during transfemoral transcatheter aortic valve implantation (TF-TAVI) cause serious issues in the future, if unresolved, but the best strategies to manage these complications remains unclear. This study aimed to comprehensively assess access-site complications during percutaneous TF-TAVI in terms of their management.
METHODS
Using the prospective, multicentre, observational registry OCEAN (Optimized Transcatheter Valvular Intervention), 1497 patients who underwent percutaneous TF-TAVI between October 2013 and May 2017 were identified. The incidence, predictors, temporal changes, and prognosis of access-site complications along with its treatment strategy and re-intervention rate were evaluated.
RESULTS
Access-site complications occurred in 105 patients (7.0%) and was predicted with lower body-mass-index (OR, 0.94; 95% CI; 0.89-0.99; p = 0.03) and higher sheath-to-femoral-artery-ratio (OR, 1.12; 95% CI, 1.03-1.24; p < 0.002). The incidence of access-site complications declined over time, irrespective of the increasing number of percutaneous TF-TAVI cases. Access-site complications were treated by conservative therapy (n = 19, 18%), interventional procedures (n = 42, 40%), rescue surgical repair (SR) (n = 10, 10%), and primary SR (n = 34, 32%). The severity of complications differed but the re-intervention rate was similar among 4 groups (p = 0.46). Re-intervention was not needed, except for a case of common femoral artery stenosis/occlusion induced by ProGlide. The need for all SRs decreased annually. Access-site complications were not associated with 30 days- and 1 year-survival rate.
CONCLUSIONS
The incidence of access-site complications was not low but has declined annually. Access-site complications are not related to worse outcomes after successful management. Interventional procedure is acceptable as the first-line strategy to treat access-site complications.
Identifiants
pubmed: 34391679
pii: S1553-8389(21)00570-4
doi: 10.1016/j.carrev.2021.08.004
pii:
doi:
Types de publication
Case Reports
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
11-18Informations de copyright
Copyright © 2021 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest Drs. Yamamoto, Tada, Naganuma, Shirai, Mizutani, Tabata, Ueno, and Watanabe are clinical proctors for Edwards Lifesciences and Medtronic. Drs. Takagi and Hayashida are clinical proctors of Edwards Lifesciences. The remaining authors have no conflicts of interest to disclose.