Iatrogenic Atrial Septal Defects Following Transcatheter Mitral Valve Repair and Implications of Interventional Closure.
atrial septal defect
closure
heart failure
shunt
transcatheter mitral valve edge-to-edge repair
Journal
JACC. Cardiovascular interventions
ISSN: 1876-7605
Titre abrégé: JACC Cardiovasc Interv
Pays: United States
ID NLM: 101467004
Informations de publication
Date de publication:
27 12 2021
27 12 2021
Historique:
received:
19
04
2021
revised:
30
08
2021
accepted:
21
09
2021
entrez:
24
12
2021
pubmed:
25
12
2021
medline:
31
3
2022
Statut:
ppublish
Résumé
The authors investigated whether iatrogenic atrial septal defect (iASD) closure post-transcatheter mitral valve edge-to-edge repair (TMVR) is superior to conservative therapy (CT) and whether outcomes (death/heart failure [HF] hospitalization) differ between patients with and without an iASD post-TMVR. Transseptal access for TMVR can create an iASD, which is associated with impaired outcomes. Controversially, the creation of an iASD in HF has been linked to improved hemodynamics. 80 patients with an iASD and relevant left-to-right shunting (Qp:Qs ≥1.3) 30 days following TMVR were randomized to CT or interventional closure of the iASD (MITHRAS [Closure of Iatrogenic Atrial Septal Defect Following Transcatheter Mitral Valve Repair] cohort), and 235 patients without an iASD served as a comparative cohort. All patients of the MITHRAS cohort (mean age 77 ± 9 years, 39% women) received their allocated treatment, and follow-up was completed for all MITHRAS and comparative cohort (mean age 77 ± 8 years, 47% women) patients. Twelve months post-TMVR, there was no significant difference in the combined endpoint of death or HF hospitalization within the MITHRAS cohort (iASD closure: 35% vs CT 50%; P = 0.26). The combined endpoint was more frequent among patients within the MITHRAS cohort as opposed to the comparative cohort (43% vs 17%; P < 0.0001), primarily driven by a higher rate of HF hospitalization (34% vs 8%; P = 0.004). In this randomized controlled trial, interventional closure of a relevant iASD 1 month after TMVR did not result in improved clinical outcomes at 12 months post-TMVR. Patients with an iASD are at higher risk for HF hospitalization independent of iASD management and warrant close follow-up. (Closure of Iatrogenic Atrial Septal Defect Following Transcatheter Mitral Valve Repair [MITHRAS]; NCT03024268).
Sections du résumé
OBJECTIVES
The authors investigated whether iatrogenic atrial septal defect (iASD) closure post-transcatheter mitral valve edge-to-edge repair (TMVR) is superior to conservative therapy (CT) and whether outcomes (death/heart failure [HF] hospitalization) differ between patients with and without an iASD post-TMVR.
BACKGROUND
Transseptal access for TMVR can create an iASD, which is associated with impaired outcomes. Controversially, the creation of an iASD in HF has been linked to improved hemodynamics.
METHODS
80 patients with an iASD and relevant left-to-right shunting (Qp:Qs ≥1.3) 30 days following TMVR were randomized to CT or interventional closure of the iASD (MITHRAS [Closure of Iatrogenic Atrial Septal Defect Following Transcatheter Mitral Valve Repair] cohort), and 235 patients without an iASD served as a comparative cohort.
RESULTS
All patients of the MITHRAS cohort (mean age 77 ± 9 years, 39% women) received their allocated treatment, and follow-up was completed for all MITHRAS and comparative cohort (mean age 77 ± 8 years, 47% women) patients. Twelve months post-TMVR, there was no significant difference in the combined endpoint of death or HF hospitalization within the MITHRAS cohort (iASD closure: 35% vs CT 50%; P = 0.26). The combined endpoint was more frequent among patients within the MITHRAS cohort as opposed to the comparative cohort (43% vs 17%; P < 0.0001), primarily driven by a higher rate of HF hospitalization (34% vs 8%; P = 0.004).
CONCLUSIONS
In this randomized controlled trial, interventional closure of a relevant iASD 1 month after TMVR did not result in improved clinical outcomes at 12 months post-TMVR. Patients with an iASD are at higher risk for HF hospitalization independent of iASD management and warrant close follow-up. (Closure of Iatrogenic Atrial Septal Defect Following Transcatheter Mitral Valve Repair [MITHRAS]; NCT03024268).
Identifiants
pubmed: 34949392
pii: S1936-8798(21)01785-4
doi: 10.1016/j.jcin.2021.09.023
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT03024268']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2685-2694Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Funding Support and Author Disclosures This work was funded by the Leipzig Heart Institute and Occlutech. Dr Lurz has received research grants from Edwards Lifesciences, ReCor, and Occlutech. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.