YingXing Wu, MD, Eric G. Butchart, FRCS, Jeffrey S

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Clinical Evaluation of New Heart Valve Prostheses: Update of Objective Performance Criteria YingXing Wu, MD, Eric G. Butchart, FRCS, Jeffrey S. Borer, MD, Ajit Yoganathan, PhD, Gary L. Grunkemeier, PhD The Annals of Thoracic Surgery Volume 98, Issue 5, Pages 1865-1874 (November 2014) DOI: 10.1016/j.athoracsur.2014.05.006 Copyright © 2014 The Society of Thoracic Surgeons Terms and Conditions

Fig 1 Thromboembolism rates (circles) and 90% confidence intervals (horizontal lines) by valve type and position. Each circle and line represents one of the series, and they are placed in ascending order along the vertical axis by their complication rates (as read from circles' placement along the horizontal axis). Black circles and lines are used for safety and effectiveness series; blue circles and lines for literature search series. The solid vertical lines are the original objective performance criteria (red) and the updated objective performance criteria (green). (A) Mechanical valve, aortic valve replacement; (B) mechanical valve, mitral valve replacement; (C) tissue valve, aortic valve replacement; (D) tissue valve, mitral valve replacement. The Annals of Thoracic Surgery 2014 98, 1865-1874DOI: (10.1016/j.athoracsur.2014.05.006) Copyright © 2014 The Society of Thoracic Surgeons Terms and Conditions

Fig 2 Major bleeding rates (circles) and 90% confidence intervals (horizontal lines) by valve type and position. Each circle and line represents one of the series, and they are placed in ascending order along the vertical axis by their complication rates (as read from circles' placement along the horizontal axis). Black circles and lines are used for safety and effectiveness series; blue circles and lines for literature search series. The solid vertical lines are the original objective performance criteria (red) and the updated objective performance criteria (green). (A) Mechanical valve, aortic valve replacement; (B) mechanical valve, mitral valve replacement; (C) tissue valve, aortic valve replacement; (D) tissue valve, mitral valve replacement. The Annals of Thoracic Surgery 2014 98, 1865-1874DOI: (10.1016/j.athoracsur.2014.05.006) Copyright © 2014 The Society of Thoracic Surgeons Terms and Conditions

Fig 3 Thrombosis rates (circles) and 90% confidence intervals (horizontal lines) by valve type and position. Each circle and line represents one of the series, and they are placed in ascending order along the vertical axis by their complication rates (as read from circles' placement along the horizontal axis). Black circles and lines are used for safety and effectiveness series; blue circles and lines for literature search series. The solid vertical lines are the original objective performance criteria (red) and the updated objective performance criteria (green). (A) Mechanical valve, aortic valve replacement; (B) mechanical valve, mitral valve replacement; (C) tissue valve, aortic valve replacement; (D) tissue valve, mitral valve replacement. The Annals of Thoracic Surgery 2014 98, 1865-1874DOI: (10.1016/j.athoracsur.2014.05.006) Copyright © 2014 The Society of Thoracic Surgeons Terms and Conditions

Fig 4 Endocarditis rates (circles) and 90% confidence intervals (horizontal lines) by valve type and position. Each circle and line represents one of the series, and they are placed in ascending order along the vertical axis by their complication rates (as read from circles' placement along the horizontal axis). Black circles and lines are used for safety and effectiveness series; blue circles and lines for literature search series. The solid vertical lines are the original objective performance criteria (red) and the updated objective performance criteria (green). (A) Mechanical valve, aortic valve replacement; (B) mechanical valve, mitral valve replacement; (C) tissue valve, aortic valve replacement; (D) tissue valve, mitral valve replacement. The Annals of Thoracic Surgery 2014 98, 1865-1874DOI: (10.1016/j.athoracsur.2014.05.006) Copyright © 2014 The Society of Thoracic Surgeons Terms and Conditions

Fig 5 Major leak rates (circles) and 90% confidence intervals (horizontal lines) by valve type and position. Each circle and line represents one of the series, and they are placed in ascending order along the vertical axis by their complication rates (as read from circles' placement along the horizontal axis). Black circles and lines are used for safety and effectiveness series; blue circles and lines for literature search series. The solid vertical lines are the original objective performance criteria (red) and the updated objective performance criteria (green). (A) Mechanical valve, aortic valve replacement; (B) mechanical valve, mitral valve replacement; (C) tissue valve, aortic valve replacement; (D) tissue valve, mitral valve replacement. The Annals of Thoracic Surgery 2014 98, 1865-1874DOI: (10.1016/j.athoracsur.2014.05.006) Copyright © 2014 The Society of Thoracic Surgeons Terms and Conditions

Fig 6 Comparison of the allowable number of events and rates between the original (red) and proposed (green) new objective performance criteria (OPC), for an aortic bioprosthetic valve at the end of an 800 patient-year study. The values of two times the original OPC are shown by horizontal red lines. For thromboembolism (TE), the maximum number of events is 29 (indicated by the red arrow—the highest confidence limit, which is below the red line), which corresponds to a linearized rate of 3.6% per patient-year (red dot). The values of two times the new OPC are shown by horizontal green lines. The maximum number of TE events is 23 (green dot), which corresponds to a rate of 2.9% per patient-year. For major bleeding (BLD), to pass the original test, the maximum number of events is 8 (red dot), corresponding to a rate of 1.0% per patient-year; and to pass the new test, the maximum number of events is 9 (green dot), corresponding to a rate of 1.1% per patient-year. (CI = confidence interval.) The Annals of Thoracic Surgery 2014 98, 1865-1874DOI: (10.1016/j.athoracsur.2014.05.006) Copyright © 2014 The Society of Thoracic Surgeons Terms and Conditions