A new paradigm for obtaining marketing approval for pediatric-sized prosthetic heart valves Ajit P. Yoganathan, PhD, Mark Fogel, MD, Susan Gamble, BS,

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Presentation transcript:

A new paradigm for obtaining marketing approval for pediatric-sized prosthetic heart valves Ajit P. Yoganathan, PhD, Mark Fogel, MD, Susan Gamble, BS, MBA, Michael Morton, MA, Paul Schmidt, MS, Jeff Secunda, MS, MBA, Sara Vidmar, MBA, Pedro del Nido, MD The Journal of Thoracic and Cardiovascular Surgery Volume 146, Issue 4, Pages 879-886 (October 2013) DOI: 10.1016/j.jtcvs.2013.04.016 Copyright © 2013 The American Association for Thoracic Surgery Terms and Conditions

Figure 1 Distribution of valve surgical procedures performed at 1 center (Children’s Hospital Boston, Boston, Mass) over a 5-year period. CAVC, Complete atrioventricular canal; AVC, atrioventricular canal. The Journal of Thoracic and Cardiovascular Surgery 2013 146, 879-886DOI: (10.1016/j.jtcvs.2013.04.016) Copyright © 2013 The American Association for Thoracic Surgery Terms and Conditions

Figure 2 Competing-risks depiction of events after initial aortic valve replacement (AVR) in 160 children. All patients are represented in the graph as alive at the initial AVR and thereafter migrate to 1 of 3 mutually exclusive end states (death, subsequent AVR, or remaining alive without subsequent AVR) at a time-dependent rate defined by the underlying hazard functions. At any point, the sum of the proportion of children in each state is 100%. The Journal of Thoracic and Cardiovascular Surgery 2013 146, 879-886DOI: (10.1016/j.jtcvs.2013.04.016) Copyright © 2013 The American Association for Thoracic Surgery Terms and Conditions

Figure 3 Freedom from reoperation for patients having valves implanted in the atrioventricular position. Numbers under the curve indicate patients at risk. CI, Confidence interval. The Journal of Thoracic and Cardiovascular Surgery 2013 146, 879-886DOI: (10.1016/j.jtcvs.2013.04.016) Copyright © 2013 The American Association for Thoracic Surgery Terms and Conditions