Patients with a Ruptured Abdominal Aortic Aneurysm Are Better Informed in Hospitals with an "EVAR-preferred" Strategy: An Instrumental Variable Analysis of the Dutch Surgical Aneurysm Audit.


Journal

Annals of vascular surgery
ISSN: 1615-5947
Titre abrégé: Ann Vasc Surg
Pays: Netherlands
ID NLM: 8703941

Informations de publication

Date de publication:
Nov 2020
Historique:
received: 17 04 2020
revised: 28 05 2020
accepted: 01 06 2020
pubmed: 20 6 2020
medline: 1 12 2020
entrez: 20 6 2020
Statut: ppublish

Résumé

While several observational studies suggested a lower postoperative mortality after minimal invasive endovascular aneurysm repair (EVAR) in patients with a ruptured abdominal aortic aneurysm (RAAA) compared to conventional open surgical repair (OSR), landmark randomized controlled trials have not been able to prove the superiority of EVAR over OSR. Randomized controlled trials contain a selected, homogeneous population, influencing external validity. Observational studies are biased and adjustment of confounders can be incomplete. Instrumental variable (IV) analysis (pseudorandomization) may help to answer the question if patients with an RAAA have lower postoperative mortality when undergoing EVAR compared to OSR. This is an observational study including all patients with an RAAA, registered in the Dutch Surgical Aneurysm Audit between 2013 and 2017. The risk difference (RD) in postoperative mortality (30 days/in-hospital) between patients undergoing EVAR and OSR was estimated, in which adjustment for confounding was performed in 3 ways: linear model adjusted for observed confounders, propensity score model (multivariable logistic regression analysis), and IV analysis (two-stage least square regression), adjusting for observed and unobserved confounders, with the variation in percentage of EVAR per hospital as the IV instrument. 2419 patients with an RAAA (1489 OSR and 930 EVAR) were included. Unadjusted postoperative mortality was 34.9% after OSR and 22.6% after EVAR (RD 12.3%, 95% CI 8.5-16%). The RD adjusted for observed confounders using linear regression analysis and propensity score analysis was, respectively, 12.3% (95% CI 9.6-16.7%) and 13.2% (95%CI 9.3-17.1%) in favor of EVAR. Using IV analysis, adjusting for observed and unobserved confounders, RD was 8.9% (95% CI -1.1-18.9%) in favor of EVAR. Adjusting for observed confounders, patients with an RAAA undergoing EVAR had a significant better survival than OSR in a consecutive large cohort. Adjustment for unobserved confounders resulted in a clinical relevant RD. An "EVAR preference strategy" in patients with an RAAA could result in lower postoperative mortality.

Sections du résumé

BACKGROUND BACKGROUND
While several observational studies suggested a lower postoperative mortality after minimal invasive endovascular aneurysm repair (EVAR) in patients with a ruptured abdominal aortic aneurysm (RAAA) compared to conventional open surgical repair (OSR), landmark randomized controlled trials have not been able to prove the superiority of EVAR over OSR. Randomized controlled trials contain a selected, homogeneous population, influencing external validity. Observational studies are biased and adjustment of confounders can be incomplete. Instrumental variable (IV) analysis (pseudorandomization) may help to answer the question if patients with an RAAA have lower postoperative mortality when undergoing EVAR compared to OSR.
METHODS METHODS
This is an observational study including all patients with an RAAA, registered in the Dutch Surgical Aneurysm Audit between 2013 and 2017. The risk difference (RD) in postoperative mortality (30 days/in-hospital) between patients undergoing EVAR and OSR was estimated, in which adjustment for confounding was performed in 3 ways: linear model adjusted for observed confounders, propensity score model (multivariable logistic regression analysis), and IV analysis (two-stage least square regression), adjusting for observed and unobserved confounders, with the variation in percentage of EVAR per hospital as the IV instrument.
RESULTS RESULTS
2419 patients with an RAAA (1489 OSR and 930 EVAR) were included. Unadjusted postoperative mortality was 34.9% after OSR and 22.6% after EVAR (RD 12.3%, 95% CI 8.5-16%). The RD adjusted for observed confounders using linear regression analysis and propensity score analysis was, respectively, 12.3% (95% CI 9.6-16.7%) and 13.2% (95%CI 9.3-17.1%) in favor of EVAR. Using IV analysis, adjusting for observed and unobserved confounders, RD was 8.9% (95% CI -1.1-18.9%) in favor of EVAR.
CONCLUSIONS CONCLUSIONS
Adjusting for observed confounders, patients with an RAAA undergoing EVAR had a significant better survival than OSR in a consecutive large cohort. Adjustment for unobserved confounders resulted in a clinical relevant RD. An "EVAR preference strategy" in patients with an RAAA could result in lower postoperative mortality.

Identifiants

pubmed: 32554198
pii: S0890-5096(20)30516-1
doi: 10.1016/j.avsg.2020.06.015
pii:
doi:

Types de publication

Comparative Study Journal Article Observational Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

332-344

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Informations de copyright

Copyright © 2020 Elsevier Inc. All rights reserved.

Auteurs

Eleonora G Karthaus (EG)

Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands; Dutch Institute for Clinical Auditing, Leiden, The Netherlands. Electronic address: e.g.karthaus@gmail.com.

Niki Lijftogt (N)

Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands; Dutch Institute for Clinical Auditing, Leiden, The Netherlands.

Anco Vahl (A)

Department of Surgery, OLVG, Amsterdam, The Netherlands; Department of Clinical Epidemiology, OLVG, Amsterdam, The Netherlands.

Esmee M van der Willik (EM)

Dutch Institute for Clinical Auditing, Leiden, The Netherlands; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.

Sonia Amodio (S)

Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, The Netherlands.

Erik W van Zwet (EW)

Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, The Netherlands.

Jaap F Hamming (JF)

Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.

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