title: St Jude Medical Epic porcine bioprosthesis: results of the regulatory evaluation.
abstract: BACKGROUND
  The St Jude Medical Epic heart valve (St Jude Medical, Inc, St Paul, Minn) is a tricomposite glutaraldehyde-preserved porcine bioprosthesis. The St Jude Medical Biocor porcine bioprosthesis is the precursor valve to the St Jude Medical Epic valve. The Epic valve is identical to the Biocor valve except that it is treated with Linx AC ethanol-based calcium mitigation therapy.
  
  
  METHODS
  The St Jude Medical Epic valve was implanted in 761 patients (mean age 73.9 ± 9.2 years) between 2003 and 2006 in the US Food and Drug Administration regulatory study in 22 investigational centers. The position distribution was 557 aortic valve replacements, 175 mitral valve replacements, and 29 double valve replacements. Concomitant coronary artery bypass grafting was performed in 50.8% of patients undergoing aortic valve replacement and 36.6% of those undergoing mitral valve replacement.
  
  
  RESULTS
  The early mortality was 3.6% in aortic and 2.3% in mitral valve replacement. The follow-up was 1675.5 patient-years with a mean of 2.2 ± 1.2 years/patient. Late mortality was 5.2%/patient-year in aortic and 6.6%/patient-year in mitral valve replacement. The late major thromboembolism rate was 0.98%/patient-year for aortic and 2.6%/patient-year for mitral valve replacement. There were 19 reoperations, including 2 for structural valve deterioration, 1 for thrombosis, 9 for nonstructural dysfunction, and 7 for prosthetic valve endocarditis. The actuarial freedom from reoperation owing to structural valve deterioration for aortic valve replacement at 4 years for age 60 years or less was 93.3% ± 6.4%; for ages 61 to 70 years, 98.1% ± 1.9%; and for older than 70 years, 100% (P = .0006 > 70 vs ≤ 60 years). There were no events of structural deterioration with mitral valve replacement. The actuarial freedom from major thromboembolism for all patients at 4 years was 93.6% ± 1.0%. The 2 cases of structural valve deterioration occurred in aortic valves that became perforated without calcification causing aortic regurgitation.
  
  
  CONCLUSIONS
  The performance of the St Jude Medical Epic porcine bioprosthesis is satisfactory at 4 years for both aortic and mitral valve replacement. This study establishes the early clinical performance including durability of this porcine bioprosthesis.
authors.affiliation: University of British Columbia, Vancouver, British Columbia, Canada. eric.jamieson@vch.ca
authors.forename: W R Eric
authors.initials: WR
authors.lastname: Jamieson
authors.forename: Clifton T P
authors.initials: CT
authors.lastname: Lewis
authors.forename: Marc P
authors.initials: MP
authors.lastname: Sakwa
authors.forename: Denton A
authors.initials: DA
authors.lastname: Cooley
authors.forename: Vibhu R
authors.initials: VR
authors.lastname: Kshettry
authors.forename: Kent W
authors.initials: KW
authors.lastname: Jones
authors.forename: Tirone E
authors.initials: TE
authors.lastname: David
authors.forename: John A
authors.initials: JA
authors.lastname: Sullivan
authors.forename: Guy J
authors.initials: GJ
authors.lastname: Fradet
authors.forename: David S
authors.initials: DS
authors.lastname: Bach
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D001021:Aortic Valve / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000209:etiology / Q000601:surgery; D001705:Bioprosthesis; D002170:Canada; D016009:Chi-Square Distribution; D018795:Device Approval; D004696:Endocarditis / Q000209:etiology / Q000601:surgery; D005260:Female; D006349:Heart Valve Diseases / Q000401:mortality / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery*; D011474:Prosthesis Design; D011475:Prosthesis Failure; D016459:Prosthesis-Related Infections / Q000209:etiology / Q000601:surgery; D012086:Reoperation; D018570:Risk Assessment; D012307:Risk Factors; D013552:Swine; D013923:Thromboembolism / Q000209:etiology / Q000601:surgery; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult