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You are here: Contents > 2015 > Volume 24 Number 1 January 2015 > DEVICE EVALUATION > Long-Term Clinical Outcomes of Silzone Era St. Jude Medical Mechanical Heart Valves

Long-Term Clinical Outcomes of Silzone Era St. Jude Medical Mechanical Heart Valves

J. Matthew Brennan1, Yue Zhao1, Judson Williams1, Sean O’Brien1, Rachel Dokholyan1, James Gammie2, Fred Edwards3, Nilsa Loyo-Berrios4, Daniel Canos4, Thomas Gross4, Danica Marinac-Dabic4, Eric Peterson1

1Duke Clinical Research Institute, Durham, NC, 2Division of Cardiothoracic Surgery, University of Maryland Medical Center, Baltimore, MD, 3Division of Cardiothoracic Surgery, University of Florida Health Science Center, Jacksonville, FL, 4United States Food and Drug Administration, Rockville, MD, USA

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.

Methods: 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.

Results: 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.

Conclusion: 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. These data do not substantiate continued public health concerns associated with Silzone era valve prostheses among older individuals.

The Journal of Heart Valve Disease 2014;23:683-687


Long-Term Clinical Outcomes of Silzone Era St. Jude Medical Mechanical Heart Valves

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