title: Long-Term Clinical Outcomes of Silzone Era St. Jude Medical Mechanical Heart Valves.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.forename: J Matthew
authors.initials: JM
authors.lastname: Brennan
authors.forename: Yue
authors.initials: Y
authors.lastname: Zhao
authors.forename: Judson
authors.initials: J
authors.lastname: Williams
authors.forename: Sean
authors.initials: S
authors.lastname: O'Brien
authors.forename: Rachel
authors.initials: R
authors.lastname: Dokholyan
authors.forename: James
authors.initials: J
authors.lastname: Gammie
authors.forename: Fred
authors.initials: F
authors.lastname: Edwards
authors.forename: Nilsa
authors.initials: N
authors.lastname: Loyo-Berrios
authors.forename: Daniel
authors.initials: D
authors.lastname: Canos
authors.forename: Thomas
authors.initials: T
authors.lastname: Gross
authors.forename: Danica
authors.initials: D
authors.lastname: Marinac-Dabic
authors.forename: Eric
authors.initials: E
authors.lastname: Peterson
mesh_terms: D000368:Aged; D001021:Aortic Valve / Q000503:physiopathology / Q000601:surgery*; D016208:Databases, Factual; D005260:Female; D006349:Heart Valve Diseases / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D017052:Hospital Mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D057052:Medical Device Recalls; D006278:Medicare; D008943:Mitral Valve / Q000503:physiopathology / Q000601:surgery*; D011183:Postoperative Complications / Q000401:mortality / Q000601:surgery; D057216:Propensity Score; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D012086:Reoperation; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States