Implementation of echocardiography core laboratory best practices: a case study of the PARTNER I trial.
Implementation of echocardiography core laboratory best practices: a case study of the PARTNER I trial.
- 2013
Available online from MWHC library: 1995 - present
BACKGROUND: Multicenter clinical trials use echocardiographic core laboratories to ensure expertise and consistency in the assessment of imaging eligibility criteria, as well as safety and efficacy end points. The aim of this study was to report the real-world implementation of guidelines for best practices in echocardiographic core laboratories, including their feasibility and quality results, in a large, international multicenter trial. CONCLUSIONS: This real-world echocardiographic core lab experience in the PARTNER I trial demonstrates that a high standard of measurability and reproducibility can result from extensive quality assurance efforts in both image acquisition and analysis. These results and the echocardiographic data reported here provide a reference for future studies of aortic stenosis patients and should encourage the wider use of echocardiography in clinical research. Copyright 2013 American Society of Echocardiography. Published by Mosby, Inc. All rights reserved. METHODS: Processes and procedures were developed to optimize the acquisition and analysis of echocardiograms for the Placement of Aortic Transcatheter Valves (PARTNER) I trial of percutaneous aortic valve replacement for aortic stenosis. Comparison of baseline findings in the operative and nonoperative cohorts and reproducibility analyses were performed. RESULTS: Echocardiography was performed in 1,055 patients (mean age, 83 years; 54% men) The average peak and mean aortic valve gradients were 73 + 24 and 43 + 15 mm Hg, and the average aortic valve area was 0.64 + 0.20 cm(2). The average ejection fraction was 52 + 13% by visual estimation and 53 + 14% by biplane planimetry. The mean left ventricular mass index was 151 + 42 g/m(2). The inoperable cohort had lower left ventricular mass and mass indexes and tended to have more severe mitral regurgitation. Core lab reproducibility was excellent, with intraclass correlation coefficients ranging from 0.92 to 0.99 and statistics from 0.58 to 0.85 for key variables. The image acquisition quality improvement process brought measurability to >85%, which was maintained for the duration of the study.
English
0894-7317
*Aortic Valve Stenosis/us [Ultrasonography]
*Benchmarking
*Echocardiography/st [Standards]
*Heart Valve Prosthesis Implantation
*Surgery, Computer-Assisted/st [Standards]
Aged
Aged, 80 and over
Aorta/us [Ultrasonography]
Aortic Valve Stenosis/pp [Physiopathology]
Aortic Valve Stenosis/su [Surgery]
Clinical Trials as Topic
Echocardiography, Doppler
Feasibility Studies
Female
Guideline Adherence
Heart Ventricles/us [Ultrasonography]
Hemodynamics
Humans
Image Processing, Computer-Assisted
Laboratories
Male
Practice Guidelines as Topic
Quality Assurance, Health Care
Reproducibility of Results
MedStar Heart & Vascular Institute
Clinical Trial
Journal Article
Multicenter Study
Available online from MWHC library: 1995 - present
BACKGROUND: Multicenter clinical trials use echocardiographic core laboratories to ensure expertise and consistency in the assessment of imaging eligibility criteria, as well as safety and efficacy end points. The aim of this study was to report the real-world implementation of guidelines for best practices in echocardiographic core laboratories, including their feasibility and quality results, in a large, international multicenter trial. CONCLUSIONS: This real-world echocardiographic core lab experience in the PARTNER I trial demonstrates that a high standard of measurability and reproducibility can result from extensive quality assurance efforts in both image acquisition and analysis. These results and the echocardiographic data reported here provide a reference for future studies of aortic stenosis patients and should encourage the wider use of echocardiography in clinical research. Copyright 2013 American Society of Echocardiography. Published by Mosby, Inc. All rights reserved. METHODS: Processes and procedures were developed to optimize the acquisition and analysis of echocardiograms for the Placement of Aortic Transcatheter Valves (PARTNER) I trial of percutaneous aortic valve replacement for aortic stenosis. Comparison of baseline findings in the operative and nonoperative cohorts and reproducibility analyses were performed. RESULTS: Echocardiography was performed in 1,055 patients (mean age, 83 years; 54% men) The average peak and mean aortic valve gradients were 73 + 24 and 43 + 15 mm Hg, and the average aortic valve area was 0.64 + 0.20 cm(2). The average ejection fraction was 52 + 13% by visual estimation and 53 + 14% by biplane planimetry. The mean left ventricular mass index was 151 + 42 g/m(2). The inoperable cohort had lower left ventricular mass and mass indexes and tended to have more severe mitral regurgitation. Core lab reproducibility was excellent, with intraclass correlation coefficients ranging from 0.92 to 0.99 and statistics from 0.58 to 0.85 for key variables. The image acquisition quality improvement process brought measurability to >85%, which was maintained for the duration of the study.
English
0894-7317
*Aortic Valve Stenosis/us [Ultrasonography]
*Benchmarking
*Echocardiography/st [Standards]
*Heart Valve Prosthesis Implantation
*Surgery, Computer-Assisted/st [Standards]
Aged
Aged, 80 and over
Aorta/us [Ultrasonography]
Aortic Valve Stenosis/pp [Physiopathology]
Aortic Valve Stenosis/su [Surgery]
Clinical Trials as Topic
Echocardiography, Doppler
Feasibility Studies
Female
Guideline Adherence
Heart Ventricles/us [Ultrasonography]
Hemodynamics
Humans
Image Processing, Computer-Assisted
Laboratories
Male
Practice Guidelines as Topic
Quality Assurance, Health Care
Reproducibility of Results
MedStar Heart & Vascular Institute
Clinical Trial
Journal Article
Multicenter Study