Rebecca T Hahn1, Philippe Pibarot2, Neil J Weissman3, Leonardo Rodriguez4, Wael A Jaber4. 1. Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York. Electronic address: rth2@columbia.edu. 2. Québec Heart and Lung Institute, Laval University, Québec City, Québec, Canada. 3. Medstar Health Research Institute, Washington, District of Columbia. 4. Cleveland Clinic Foundation, Cleveland, Ohio.
Abstract
BACKGROUND: There is significant disparity in the reported incidence of moderate and severe paravalvular aortic regurgitation (PAR) between the Placement of Aortic Transcatheter Valves (PARTNER) I and PARTNER II trials, which may be related to the echocardiographic methodologies used by separate core laboratories. To further explore the variability in echocardiographic interpretation of PAR, agreement between the grading of PAR by the core laboratory of PARTNER IIB was compared with that by a consortium of echocardiography core laboratory directors. METHODS: The PARTNER IIB core laboratory reevaluated patients using primarily the circumferential extent of the regurgitant jet for PAR. A consortium of echocardiography core laboratory directors was formed to evaluate the echocardiographic images and to grade PAR and central and total aortic regurgitation in a randomly chosen subset of the randomized patients in the PARTNER IIB trial using a multiwindow, multiparametric approach. Both a four-class scale (none or trace, mild, moderate, and severe) and a seven-class (none, trace, mild, mild to moderate, moderate, moderate to severe, and severe) scale were used. Levels of grading agreement between the consortium and original core laboratory in both scales were determined using weighted κ statistics. RESULTS: Only 87 patients assessed for PAR by the consortium could be paired with readings by the PARTNER IIB core laboratory. Using the four-class grading scheme the weighted κ statistic for PAR was 0.481 (95% confidence limits, 0.367, 0.595). Using the seven-class scale, the weighted κ statistic for PAR was 0.517 (95% confidence limits, 0.431, 0.607). For either grading scheme, 15.9% of patients graded by the PARTNER IIB core laboratory as having moderate PAR would have been graded as having mild PAR using the multiparametric approach. Similar results were seen for central and total aortic regurgitation assessments. CONCLUSIONS: Using primarily the circumferential extent criteria, the PARTNER IIB core laboratory overestimated the severity of PAR compared to the consortium using a multi-parametric approach. Although a more granular classification scheme for PAR may slightly improve concordance between core laboratories, differences in the incidence of moderate or severe PAR are likely related to differences in grading methodology. A multiparametric approach is advocated, and other echocardiographic methods for assessing PAR deserve further study.
RCT Entities:
BACKGROUND: There is significant disparity in the reported incidence of moderate and severe paravalvular aortic regurgitation (PAR) between the Placement of Aortic Transcatheter Valves (PARTNER) I and PARTNER II trials, which may be related to the echocardiographic methodologies used by separate core laboratories. To further explore the variability in echocardiographic interpretation of PAR, agreement between the grading of PAR by the core laboratory of PARTNER IIB was compared with that by a consortium of echocardiography core laboratory directors. METHODS: The PARTNER IIB core laboratory reevaluated patients using primarily the circumferential extent of the regurgitant jet for PAR. A consortium of echocardiography core laboratory directors was formed to evaluate the echocardiographic images and to grade PAR and central and total aortic regurgitation in a randomly chosen subset of the randomized patients in the PARTNER IIB trial using a multiwindow, multiparametric approach. Both a four-class scale (none or trace, mild, moderate, and severe) and a seven-class (none, trace, mild, mild to moderate, moderate, moderate to severe, and severe) scale were used. Levels of grading agreement between the consortium and original core laboratory in both scales were determined using weighted κ statistics. RESULTS: Only 87 patients assessed for PAR by the consortium could be paired with readings by the PARTNER IIB core laboratory. Using the four-class grading scheme the weighted κ statistic for PAR was 0.481 (95% confidence limits, 0.367, 0.595). Using the seven-class scale, the weighted κ statistic for PAR was 0.517 (95% confidence limits, 0.431, 0.607). For either grading scheme, 15.9% of patients graded by the PARTNER IIB core laboratory as having moderate PAR would have been graded as having mild PAR using the multiparametric approach. Similar results were seen for central and total aortic regurgitation assessments. CONCLUSIONS: Using primarily the circumferential extent criteria, the PARTNER IIB core laboratory overestimated the severity of PAR compared to the consortium using a multi-parametric approach. Although a more granular classification scheme for PAR may slightly improve concordance between core laboratories, differences in the incidence of moderate or severe PAR are likely related to differences in grading methodology. A multiparametric approach is advocated, and other echocardiographic methods for assessing PAR deserve further study.
Authors: Philippe Pibarot; Rebecca T Hahn; Neil J Weissman; Marie Arsenault; Jonathan Beaudoin; Mathieu Bernier; Abdellaziz Dahou; Omar K Khalique; Federico M Asch; Oumhani Toubal; Jonathon Leipsic; Philipp Blanke; Feifan Zhang; Rupa Parvataneni; Maria Alu; Howard Herrmann; Raj Makkar; Michael Mack; Richard Smalling; Martin Leon; Vinod H Thourani; Susheel Kodali Journal: JAMA Cardiol Date: 2017-11-01 Impact factor: 14.676
Authors: Declan Lloyd; Jessica G Y Luc; Ben Elias Indja; Vannessa Leung; Nelson Wang; Kevin Phan Journal: J Thorac Dis Date: 2019-01 Impact factor: 2.895
Authors: Mohammad Abdelghani; Ben Ren; Ernest Spitzer; Hiroki Tateishi; Hans Jonker; Marcel L Geleijnse; Jan G Tijssen; Robbert J de Winter; Patrick W J C Serruys; Osama I I Soliman Journal: Int J Cardiovasc Imaging Date: 2016-07-27 Impact factor: 2.357
Authors: Yosuke Miyazaki; Rodrigo Modolo; Mohammad Abdelghani; Hiroki Tateishi; Rafael Cavalcante; Carlos Collet; Taku Asano; Yuki Katagiri; Erhan Tenekecioglu; Rogério Sarmento-Leite; José A Mangione; Alexandre Abizaid; Osama I I Soliman; Yoshinobu Onuma; Patrick W Serruys; Pedro A Lemos; Fabio S de Brito Journal: Arq Bras Cardiol Date: 2018-08 Impact factor: 2.000