title: Intravascular hemolysis in patients with new-generation prosthetic heart valves: a prospective study.
abstract: OBJECTIVE
  A prospective clinical study was designed to assess the frequency and severity of intravascular hemolysis in patients with new-generation, normally functioning prosthetic heart valves.
  
  
  METHODS
  Hemolysis was evaluated in 172 patients with a mechanical prosthesis (53 CarboMedics and 119 Sorin Bicarbon) and in 106 patients with a bioprosthesis (15 St Jude Medical Toronto, 19 Baxter Perimount, and 72 Medtronic Mosaic) in the aortic position, mitral position, or both. Aortic valve replacement was performed in 206 patients, mitral valve replacement in 59 patients, and double valve replacement in 13 patients. The presence of hemolysis was assessed on the basis of the level of serum lactic dehydrogenase and serum haptoglobin and the presence and amount of reticulocytes and schistocytes in the peripheral blood. Severity of intravascular hemolysis was estimated on the basis of serum lactic dehydrogenase. Clinical, echocardiographic, and hematologic evaluations were performed 1, 6, and 12 months after discharge.
  
  
  RESULTS
  None of the 278 patients experienced decompensated anemia, whereas at 12 months, mild subclinical hemolysis was identified in 49 patients, 44 (26%) with a mechanical prosthesis and 5 (5%) with a bioprosthesis (P <.001). At multivariate analysis, independent predictors of the presence of subclinical hemolysis were mitral valve replacement (P <.001), use of a mechanical prosthesis (P =.002), and double valve replacement (P =.02). Frequency of hemolysis in patients with stented aortic bioprostheses was 3%, whereas it was absent in those with stentless valves. Among mechanical valve recipients, double versus single valve replacement (P =.04) and mitral versus aortic valve replacement (P =.05) were correlated with the presence of hemolysis; double valve recipients also showed a more severe degree of hemolysis (P =.03). In patients with a Sorin Bicarbon prosthesis, hemolysis was less frequent (22% vs 34%, P =.09) and severe (P <.001) than in those with a CarboMedics prosthesis.
  
  
  CONCLUSIONS
  In normally functioning prosthetic heart valves, subclinical hemolysis is a frequent finding. A low incidence of hemolysis is found in stented biologic prostheses, and it is absent in stentless aortic valves. Modifications of valve design may contribute to minimize the occurrence of hemolysis in mechanical prostheses.
authors.affiliation: Division of Cardiac Surgery, Cardio-Thoracic Department, University of Pisa Medical School, 56124 Pisa, Italy.
authors.forename: Gianclaudio
authors.initials: G
authors.lastname: Mecozzi
authors.forename: Aldo D
authors.initials: AD
authors.lastname: Milano
authors.forename: Marco
authors.initials: M
authors.lastname: De Carlo
authors.forename: Flavia
authors.initials: F
authors.lastname: Sorrentino
authors.forename: Stefano
authors.initials: S
authors.lastname: Pratali
authors.forename: Carmela
authors.initials: C
authors.lastname: Nardi
authors.forename: Uberto
authors.initials: U
authors.lastname: Bortolotti
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve; D001705:Bioprosthesis; D005260:Female; D006242:Haptoglobins / Q000032:analysis; D006350:Heart Valve Prosthesis / Q000009:adverse effects*; D006461:Hemolysis; D006801:Humans; D007770:L-Lactate Dehydrogenase / Q000097:blood; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve; D011446:Prospective Studies; D011474:Prosthesis Design
chemical_list: D006242:Haptoglobins; D007770:L-Lactate Dehydrogenase