Findings in Medicare and Medicaid Reported from Food and Drug Administration (Long-Term Clinical Outcomes of Silzone Era St. Jude Medical Mechanical…

Findings in Medicare and Medicaid Reported from Food and Drug Administration (Long-Term Clinical Outcomes of Silzone Era St. Jude Medical Mechanical Heart Valves)

By a News Reporter-Staff News Editor at Insurance Weekly News -- Researchers detail new data in Medicare and Medicaid. According to news reporting from Rockville, Maryland, by VerticalNews journalists, research stated, "Background and aim of the study: Since the voluntary recall of St. Jude Medical (SJM) Silzone impregnated heart valves, no large-scale study has examined their long-term outcomes."

The news correspondents obtained a quote from the research from Food and Drug Administration, "Using Medicare-linked records from the Society of Thoracic Surgeons Adult Cardiac Surgery Database (1993-2004), the clinical outcomes were evaluated through eight years among those patients who received SJM mechanical heart valves during the Silzone era (March 1998 to December 1999; n = 3,775), relative to those in both the pre-Silzone era (January 1993 to February 1998; n = 13,570) and the post-Silzone era (January 2000 to December 2004; n = 6,882). An inverse probability weighting was used to balance the observed differences in case mix. During the Silzone era, 79% of all implanted mechanical heart valves were manufactured by SJM. By eight years post-implantation, the most common adverse events in this Medicare-linked cohort (median age 71 years) were death (43.5%) and thromboembolism (14.7%), while valve reoperation (1.7%) and endocarditis (1.4%) were less common. Patients treated during the Silzone era experienced a lower associated risk of mortality to eight years than those in both the pre-Silzone era (adjusted hazards ratio (HR) 0.93, 95% confidence interval (CI) 0.88-0.98) and post-Silzone era (adjusted HR 0.92, CI 0.67-0.98), while the adjusted eight-year risks of reoperation, thromboembolism and endocarditis were similar across the three eras for the overall cohort and among both aortic valve and mitral valve patients. Medicare patients who received SJM mechanical heart valves during the Silzone era experienced similar clinical outcomes as those treated before or after the Silzone era."

According to the news reporters, the research concluded: "These data do not substantiate continued public health concerns associated with Silzone era valve prostheses among older individuals."

For more information on this research see: Long-Term Clinical Outcomes of Silzone Era St. Jude Medical Mechanical Heart Valves. Journal of Heart Valve Disease, 2015;24(1):66-73. Journal of Heart Valve Disease can be contacted at: I C R Publishers, Crispin House, 12, A South Approach, Moor Park, Northwood HA6 2ET, England.

Our news journalists report that additional information may be obtained by contacting J.M. Brennan, Food & Drug Administration, Rockville, MD 20857, United States. Additional authors for this research include Y. Zhao, J. Williams, S. O'Brien, R. Dokholyan, J. Gammie, F. Edwards, N. Loyo-Berrios, D. Canos, T. Gross, D. Marinac-Dabic and E. Peterson.

Keywords for this news article include: Maryland, Rockville, United States, Health Policy, Medicare and Medicaid, North and Central America,

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2015, NewsRx LLC