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document
Assessment of paravalvular aortic regurgitation after transcatheter aortic valve replacement : intra-core laboratory variability . 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 .
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Intervention_Surgical
transcatheter aortic valve replacement
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Intervention_Physical
echocardiographic images
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Outcome_Physical
paravalvular aortic regurgitation ( PAR )
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Outcome_Physical
PAR .
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Outcome_Physical
PAR
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Outcome_Physical
for PAR
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Outcome_Physical
the weighted κ statistic for PAR
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Outcome_Physical
the weighted κ statistic for PAR
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Outcome_Physical
moderate PAR
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Outcome_Physical
mild PAR
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Outcome_Physical
for central and total aortic regurgitation
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Outcome_Physical
of PAR
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Outcome_Physical
severe PAR
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Participant_Condition
transcatheter aortic valve replacement :
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Participant_Condition
moderate and severe paravalvular aortic regurgitation
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Participant_Condition
Placement of Aortic Transcatheter Valves ( PARTNER ) I and PARTNER II trials
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Participant_Sample-size
87
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Participant_Condition
PAR