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

Hideyuki Kawashima; Patrick W Serruys; Rodrigo Modolo; Michele Pighi; Rutao Wang; Masafumi Ono; Jean-Paul Aben; Chun Chin Chang; Hadewych Van Hauwermeiren; Bill Brunnett; Martijn Cox; Liesbeth Rosseel; Darren Mylotte; Philippe Pibarot; Willem J Flameng; Yoshinobu Onuma; Osama Soliman

doi:10.1016/j.jcin.2021.04.046

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

JACC Cardiovasc Interv. 2021 Jul 26;14(14):1523-1534. doi: 10.1016/j.jcin.2021.04.046. Epub 2021 Jun 30.

Authors

Hideyuki Kawashima¹, Patrick W Serruys², Rodrigo Modolo³, Michele Pighi⁴, Rutao Wang⁵, Masafumi Ono¹, Jean-Paul Aben⁶, Chun Chin Chang⁷, Hadewych Van Hauwermeiren⁸, Bill Brunnett⁹, Martijn Cox⁹, Liesbeth Rosseel¹⁰, Darren Mylotte¹⁰, Philippe Pibarot¹¹, Willem J Flameng¹², Yoshinobu Onuma¹⁰, Osama Soliman¹⁰

Affiliations

¹ 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.
² 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.
³ Department of Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands; Cardiology Division, Department of Internal Medicine, University of Campinas, Campinas, Brazil.
⁴ Division of Cardiology, Department of Medicine, University of Verona, Verona, Italy.
⁵ 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.
⁶ Pie Medical Imaging, Maastricht, the Netherlands.
⁷ Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
⁸ Medanex Clinic B.V., Preclinical CRO, Diest, Belgium.
⁹ Xeltis B.V., Eindhoven, the Netherlands.
¹⁰ Department of Cardiology, National University of Ireland, Galway (NUIG) and CORRIB Corelab and Center for Research and Imaging, Galway, Ireland.
¹¹ Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Université Laval, Québec City, Québec, Canada.
¹² Department of Cardiac Surgery, Katholieke Universiteit Leuven, Leuven, Belgium.

PMID: 34217623
DOI: 10.1016/j.jcin.2021.04.046

Abstract

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.

Keywords: angiography; in vitro; in vivo; mitral regurgitation; videodensitometry.

Publication types

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

MeSH terms

Animals
Aortic Valve Insufficiency* / diagnostic imaging
Aortic Valve Insufficiency* / surgery
Humans
Mitral Valve Insufficiency* / diagnostic imaging
Mitral Valve Insufficiency* / surgery
Prostheses and Implants
Reproducibility of Results
Sheep
Treatment Outcome