title: Mid-term results after heart valve replacement with the CarboMedics bileaflet prosthesis: experience with 785 implants.
abstract: BACKGROUND
  The aim of the study was to evaluate our clinical experience with the CarboMedics Heart Valve Prosthesis.
  
  
  METHODS
  Between October 1991 and December 1997, six hundred seventy-two consecutive patients (361 men, 54%; 311 women, 46%; mean age 57 +/- 12 year, range 6-73 years) underwent mechanical valve implantation at the Division of Cardiac Surgery of the University of Verona. Preoperatively, 69% of the patients were in NYHA FC III or IV. Eighty-one patients (12%) had undergone a previous cardiac operation and 14.5% had an ejection fraction less than 35%. We performed an aortic valve replacement in 309 patients (78 valved-conduits for replacement of the entire aortic root), a mitral valve replacement in 250, and a double valve in 113. 52 patients (8%) underwent associated myocardial revascularization.
  
  
  RESULTS
  Early mortality was 2.8% (5/309 aortic, 1.6%; 11/250 mitral, 4.4%; 3/113 double, 2.6%). Late mortality was 4.4%. Actuarial survival at 5 years was 89.3% (aortic, 91.1%, mitral 86.4%, double 90.5%). Thromboembolism occurred in 26 patients (3.9%) and major hemorrhagic events in 20 (3%). Nine patients (1.3%) required a reoperation, in 3 cases (0.4%) after endocarditis (Staphylococcus epidermidis). No structural deterioration occurred in our series.
  
  
  CONCLUSIONS
  Our study appears to confirm the safety and reliability of the CarboMedics mechanical valve prosthesis, even in old age groups. This bileaflet prosthesis demonstrates no structural deterioration, a low incidence of complications, and good hemodynamic performance.
authors.affiliation: Division of Cardiac Surgery, University of Verona Medical School.
authors.forename: F
authors.initials: F
authors.lastname: Santini
authors.forename: G
authors.initials: G
authors.lastname: Gatti
authors.forename: G
authors.initials: G
authors.lastname: Casali
authors.forename: R
authors.initials: R
authors.lastname: Pessotto
authors.forename: A
authors.initials: A
authors.lastname: Mazzucco
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002315:Cardiopulmonary Bypass; D002648:Child; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000401:mortality / Q000601:surgery*; D006350:Heart Valve Prosthesis / Q000009:adverse effects; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery; D011183:Postoperative Complications / Q000401:mortality; D011475:Prosthesis Failure