Impact of Preprocedural Computed Tomography on Left Atrial Appendage Closure Success: A Swiss-Apero Trial Subanalysis.
computed tomography angiography
left atrial appendage closure
procedural safety
procedural success
Journal
JACC. Cardiovascular interventions
ISSN: 1876-7605
Titre abrégé: JACC Cardiovasc Interv
Pays: United States
ID NLM: 101467004
Informations de publication
Date de publication:
12 06 2023
12 06 2023
Historique:
received:
16
12
2022
revised:
16
02
2023
accepted:
21
02
2023
medline:
16
6
2023
pubmed:
15
6
2023
entrez:
14
6
2023
Statut:
ppublish
Résumé
The benefit related to the use of preprocedural computed tomography angiography (CCTA) on top of periprocedural echocardiography to plan percutaneous left atrial appendage closure (LAAC) procedures is still unclear. The authors sought to evaluate the impact of preprocedural CCTA on LAAC procedural success. In the investigator-initiated SWISS-APERO (Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure) trial, patients undergoing echocardiography-guided LAAC were randomly assigned to receive the Amulet (Abbott) or Watchman 2.5/FLX (Boston Scientific) device across 8 European centers. According to the study protocol ongoing at the time of the procedure, the first operators had (CCTA unblinded group) or did not have (CCTA blinded group) access to preprocedural CCTA images. In this post hoc analysis, we compared blinded vs unblinded procedures in terms of procedural success defined as complete left atrial appendage occlusion as evaluated at the end of LAAC (short-term) or at the 45-day follow-up (long-term) without procedural-related complications. Among 219 LAACs preceded by CCTA, 92 (42.1%) and 127 (57.9%) were assigned to the CCTA unblinded and blinded group, respectively. After adjusting for confounders, operator unblinding to preprocedural CCTA remained associated with a higher rate of short-term procedural success (93.5% vs 81.1%; P = 0.009; adjusted OR: 2.76; 95% CI: 1.05-7.29; P = 0.040) and long-term procedural success (83.7% vs 72.4%; P = 0.050; adjusted OR: 2.12; 95% CI: 1.03-4.35; P = 0.041). In a prospective multicenter cohort of clinically indicated echocardiography-guided LAACs, unblinding of the first operators to preprocedural CCTA images was independently associated with a higher rate of both short- and long-term procedural success. Further studies are needed to better evaluate the impact of preprocedural CCTA on clinical outcomes.
Sections du résumé
BACKGROUND
The benefit related to the use of preprocedural computed tomography angiography (CCTA) on top of periprocedural echocardiography to plan percutaneous left atrial appendage closure (LAAC) procedures is still unclear.
OBJECTIVES
The authors sought to evaluate the impact of preprocedural CCTA on LAAC procedural success.
METHODS
In the investigator-initiated SWISS-APERO (Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure) trial, patients undergoing echocardiography-guided LAAC were randomly assigned to receive the Amulet (Abbott) or Watchman 2.5/FLX (Boston Scientific) device across 8 European centers. According to the study protocol ongoing at the time of the procedure, the first operators had (CCTA unblinded group) or did not have (CCTA blinded group) access to preprocedural CCTA images. In this post hoc analysis, we compared blinded vs unblinded procedures in terms of procedural success defined as complete left atrial appendage occlusion as evaluated at the end of LAAC (short-term) or at the 45-day follow-up (long-term) without procedural-related complications.
RESULTS
Among 219 LAACs preceded by CCTA, 92 (42.1%) and 127 (57.9%) were assigned to the CCTA unblinded and blinded group, respectively. After adjusting for confounders, operator unblinding to preprocedural CCTA remained associated with a higher rate of short-term procedural success (93.5% vs 81.1%; P = 0.009; adjusted OR: 2.76; 95% CI: 1.05-7.29; P = 0.040) and long-term procedural success (83.7% vs 72.4%; P = 0.050; adjusted OR: 2.12; 95% CI: 1.03-4.35; P = 0.041).
CONCLUSIONS
In a prospective multicenter cohort of clinically indicated echocardiography-guided LAACs, unblinding of the first operators to preprocedural CCTA images was independently associated with a higher rate of both short- and long-term procedural success. Further studies are needed to better evaluate the impact of preprocedural CCTA on clinical outcomes.
Identifiants
pubmed: 37316145
pii: S1936-8798(23)00517-4
doi: 10.1016/j.jcin.2023.02.027
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT03399851']
Types de publication
Randomized Controlled Trial
Multicenter Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1332-1343Commentaires 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 Aminian has been a proctor and consultant for Abbott and Boston Scientific. Dr Meneveau has received grants and personal fees from Abbott, Boston Scientific, Bayer HealthCare, BMS-Pfizer, and Medtronic; and has received personal fees from AstraZeneca, Siemens, and Terumo outside the submitted work. Dr De Marco has been a proctor and consultant for Abbott and Boston Scientific. Dr Gräni has received funding from the Swiss National Science Foundation, InnoSuisse, CAIM, and GAMBIT foundation outside the submitted work. Dr Teiger has received personal fees from Abbott for proctoring. Dr Iriart has been a proctor and consultant for Abbott and Boston Scientific. Dr Vranckx has received personal fees from Pfizer-Bristol Meyers Squibb Alliance, CSL Behring, and Daiichi Sankyo outside the submitted work. Dr Fischer has received research grants from Medtronic (beyond Swift, Swift Direct), Stryker, Rapid Medical, Penumbra, and Phenox (Distal); has been a consultant for Medtronic, Stryker, and CSL Behring (fees paid to institution); and has participated in an advisory board for Alexion/Portola and Boehringer Ingelheim (fees paid to institution). Dr Bedogni has been a proctor for Abbott, Boston Scientific, and Medtronic; and has been a consultant for Terumo and Meril. Dr Valgimigli has received grants and/or personal fees from AstraZeneca, Terumo, Alvimedica/CID, Abbott Vascular, Daiichi Sankyo, Opsens, Bayer, CoreFLOW, Idorsia Pharmaceuticals Ltd, Universität Basel Department Klinische Forschung, Vifor, Bristol Myers Squibb SA, iVascular, and Medscape. Dr Räber has received research grants to the institution by Abbott Vascular, Boston Scientific, Biotronik, Infraredx, Heartflow, Sanofi, and Regeneron; and has received speaker/consultation fees from Abbott Vascular, Amgen, AstraZeneca, CSL Behring, Canon, Occlutech, Sanofi, and Vifor. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.