Impact of Preprocedural Computed Tomography on Left Atrial Appendage Closure Success: A Swiss-Apero Trial Subanalysis.


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
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

1332-1343

Commentaires 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.

Auteurs

Roberto Galea (R)

Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland. Electronic address: https://twitter.com/RobertoGalea7.

Adel Aminian (A)

Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.

Nicolas Meneveau (N)

Besancon University Hospital, University of Burgundy Franche-Comté, Besancon, France.

Federico De Marco (F)

Department of Cardiology, Istituti di Ricovero e Cura a Carattere Scientifico Policlinico San Donato, San Donato Milanese, Milan, Italy.

Dik Heg (D)

Department of Clinical Research, Clinical Trials Unit Bern, University of Bern, Bern, Switzerland.

Frederic Anselme (F)

Department of Cardiology, University Hospital of Rouen, Rouen, France.

Christoph Gräni (C)

Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland. Electronic address: https://twitter.com/chrisgraeni.

Adrian T Huber (AT)

Department of Diagnostic, Interventional and Pediatric Radiology, Bern University Hospital, University of Bern, Bern, Switzerland.

Emmanuel Teiger (E)

Department of Cardiology, Henri-Mondor Hospital, Public Assistance Hospitals of Paris, Créteil, France.

Xavier Iriart (X)

Department of Pediatric and Adult Congenital Cardiology, Hôpital Cardiologique du Haut- Lévêque, Centre Hospitalier Universitaire de Bordeaux, Bordeaux-Pessac, France.

Anna Franzone (A)

Department of Advanced Biomedical Sciences, University Federico II University, Naples, Italy.

Pascal Vranckx (P)

Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium; Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium.

Urs Fischer (U)

Department of Neurology, Bern University Hospital, University of Bern, Bern, Switzerland; Department of Neurology, University Hospital Basel, University of Basel, Switzerland.

Giovanni Pedrazzini (G)

Cardiocentro Ticino Institute and Università della Svizzera Italiana, Lugano, Switzerland.

Francesco Bedogni (F)

Department of Cardiology, Istituti di Ricovero e Cura a Carattere Scientifico Policlinico San Donato, San Donato Milanese, Milan, Italy.

Marco Valgimigli (M)

Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland; Cardiocentro Ticino Institute and Università della Svizzera Italiana, Lugano, Switzerland.

Lorenz Räber (L)

Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland. Electronic address: lorenz.raeber@insel.ch.

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Classifications MeSH