Validation of Prosthetic Mitral Regurgitation Quantification Using Novel Angiographic Platform by Mock Circulation.


Journal

JACC. Cardiovascular interventions
ISSN: 1876-7605
Titre abrégé: JACC Cardiovasc Interv
Pays: United States
ID NLM: 101467004

Informations de publication

Date de publication:
26 07 2021
Historique:
received: 12 01 2021
revised: 22 04 2021
accepted: 27 04 2021
pubmed: 5 7 2021
medline: 30 10 2021
entrez: 4 7 2021
Statut: ppublish

Résumé

This study aimed to validate a dedicated software for quantitative videodensitometric angiographic assessment of mitral regurgitation (QMR). Quantitative videodensitometric aortography of aortic regurgitation using the time-density principle is a well-documented technique, but the angiographic assessment of mitral regurgitation (MR) remains at best semi-quantitative and operator dependent. Fourteen sheep underwent surgical mitral valve replacement using 2 different prostheses. Pre-sacrifice left ventriculograms were used to assess MR fraction (MRF) using QMR and MR volume (MRV). In an independent core lab, the CAAS QMR 0.1 was used for QMR analysis. In vitro MRF and MRV were assessed in a mock circulation at a comparable cardiac output to the in vivo one by thermodilution. The correlations and agreements of in vitro and in vivo MRF, MRV, and interobserver reproducibility for QMR analysis were assessed using the averaged cardiac cycles (CCs). In vivo derived MRF by QMR strongly correlated with in vitro derived MRF, regardless of the number of the CCs analyzed (best correlation: 3 CCs y = 0.446 + 0.994x; R = 0.784; p =0.002). The mean absolute difference between in vitro derived MRF and in vivo derived MRF from 3 CCs was 0.01 ± 4.2% on Bland-Altman analysis. In vitro MRV and in vivo MRV from 3 CCs were very strongly correlated (y = 0.196 + 1.255x; R = 0.839; p < 0.001). The mean absolute difference between in vitro MRV and in vivo MRV from 3 CCs was -1.4 ± 1.9 ml. There were very strong correlations of in vivo MRF between 2 independent analysts, regardless of the number of the CCs. In vivo MRF using the novel software is feasible, accurate, and highly reproducible. These promising results have led us to initiate the first human feasibility study comprising patients undergoing percutaneous mitral valve edge-to-edge repair.

Sections du résumé

OBJECTIVES
This study aimed to validate a dedicated software for quantitative videodensitometric angiographic assessment of mitral regurgitation (QMR).
BACKGROUND
Quantitative videodensitometric aortography of aortic regurgitation using the time-density principle is a well-documented technique, but the angiographic assessment of mitral regurgitation (MR) remains at best semi-quantitative and operator dependent.
METHODS
Fourteen sheep underwent surgical mitral valve replacement using 2 different prostheses. Pre-sacrifice left ventriculograms were used to assess MR fraction (MRF) using QMR and MR volume (MRV). In an independent core lab, the CAAS QMR 0.1 was used for QMR analysis. In vitro MRF and MRV were assessed in a mock circulation at a comparable cardiac output to the in vivo one by thermodilution. The correlations and agreements of in vitro and in vivo MRF, MRV, and interobserver reproducibility for QMR analysis were assessed using the averaged cardiac cycles (CCs).
RESULTS
In vivo derived MRF by QMR strongly correlated with in vitro derived MRF, regardless of the number of the CCs analyzed (best correlation: 3 CCs y = 0.446 + 0.994x; R = 0.784; p =0.002). The mean absolute difference between in vitro derived MRF and in vivo derived MRF from 3 CCs was 0.01 ± 4.2% on Bland-Altman analysis. In vitro MRV and in vivo MRV from 3 CCs were very strongly correlated (y = 0.196 + 1.255x; R = 0.839; p < 0.001). The mean absolute difference between in vitro MRV and in vivo MRV from 3 CCs was -1.4 ± 1.9 ml. There were very strong correlations of in vivo MRF between 2 independent analysts, regardless of the number of the CCs.
CONCLUSIONS
In vivo MRF using the novel software is feasible, accurate, and highly reproducible. These promising results have led us to initiate the first human feasibility study comprising patients undergoing percutaneous mitral valve edge-to-edge repair.

Identifiants

pubmed: 34217623
pii: S1936-8798(21)00821-9
doi: 10.1016/j.jcin.2021.04.046
pii:
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1523-1534

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures Dr. Serruys has received personal fees from Biosensors, Medtronic, Micel Technologies, Sinomedical Sciences Technology, St. Jude Medical, Philips/Volcano, Xeltis, and HeartFlow, outside the submitted work. Mr. Aben is an employee of Pie Medical Imaging. Dr. Mylotte has served as a consultant for Medtronic, Boston Scientific, and Microport. Dr. Cox and W. Brunnett are employees of Xeltis. Dr. Pibarot has received grants from Cardiac Phoenix, from Edwards Lifesciences, outside the submitted work. Dr. Soliman has received several institutional research grants outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Auteurs

Hideyuki Kawashima (H)

Department of Cardiology, National University of Ireland, Galway (NUIG) and CORRIB Corelab and Center for Research and Imaging, Galway, Ireland; Department of Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.

Patrick W Serruys (PW)

Department of Cardiology, National University of Ireland, Galway (NUIG) and CORRIB Corelab and Center for Research and Imaging, Galway, Ireland; Department of Cardiology, Imperial College of London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com.

Rodrigo Modolo (R)

Department of Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands; Cardiology Division, Department of Internal Medicine, University of Campinas, Campinas, Brazil.

Michele Pighi (M)

Division of Cardiology, Department of Medicine, University of Verona, Verona, Italy.

Rutao Wang (R)

Department of Cardiology, National University of Ireland, Galway (NUIG) and CORRIB Corelab and Center for Research and Imaging, Galway, Ireland; Department of Cardiology, Radboud University Medical Center, Nijmegen, Netherlands.

Masafumi Ono (M)

Department of Cardiology, National University of Ireland, Galway (NUIG) and CORRIB Corelab and Center for Research and Imaging, Galway, Ireland; Department of Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.

Jean-Paul Aben (JP)

Pie Medical Imaging, Maastricht, the Netherlands.

Chun Chin Chang (CC)

Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.

Hadewych Van Hauwermeiren (H)

Medanex Clinic B.V., Preclinical CRO, Diest, Belgium.

Bill Brunnett (B)

Xeltis B.V., Eindhoven, the Netherlands.

Martijn Cox (M)

Xeltis B.V., Eindhoven, the Netherlands.

Liesbeth Rosseel (L)

Department of Cardiology, National University of Ireland, Galway (NUIG) and CORRIB Corelab and Center for Research and Imaging, Galway, Ireland.

Darren Mylotte (D)

Department of Cardiology, National University of Ireland, Galway (NUIG) and CORRIB Corelab and Center for Research and Imaging, Galway, Ireland.

Philippe Pibarot (P)

Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Université Laval, Québec City, Québec, Canada.

Willem J Flameng (WJ)

Department of Cardiac Surgery, Katholieke Universiteit Leuven, Leuven, Belgium.

Yoshinobu Onuma (Y)

Department of Cardiology, National University of Ireland, Galway (NUIG) and CORRIB Corelab and Center for Research and Imaging, Galway, Ireland.

Osama Soliman (O)

Department of Cardiology, National University of Ireland, Galway (NUIG) and CORRIB Corelab and Center for Research and Imaging, Galway, Ireland.

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