title: Thromboembolism, major bleeding and mortality in patients with mechanical heart valves- a population-based cohort study.
abstract: BACKGROUND
  Low incidences of thromboembolism (TE) and bleeding in patients with mechanical heart valves (MHV) have previously been reported. This study assesses the incidence of and clinical risk factors predicting TE, major bleeding and mortality in a clinical setting.
  
  
  RESULTS
  All 546 patients undergoing anticoagulation treatment due to MHV replacement at hospitals in Malmö and Sundsvall in Sweden were monitored during 2008-2011 and the incidence of TE, major bleeding and mortality was prospectively followed. There were 398, 122 and 26 patients in the aortic group (AVR), mitral (MVR) group and the combined aortic/mitral valve group respectively. The incidence of TE was 1.8 and 2.2 per 100 patient-years in the AVR group MVR group respectively. The corresponding incidences of bleeding were 4.4 and 4.6, respectively. Independent predictor of thromboembolism was vascular disease (Odds ratio {OR}: 4.2; 95% CI: 1.0-17.4). Predictor of bleeding was previous bleeding (OR: 2.7; 95% CI: 1.4-5.3). Independent predictors of mortality was age (Hazard ratio {HR}: 1.03; 95% CI: 1.00-1.05), hypertension (HR: 2.4; 95% CI: 1.3-4.5), diabetes (HR: 2.4; 95% CI: 1.3-4.3) and alcohol overconsumption (HR: 5.2; 95% CI: 1.7-15.9). Standardized mortality/morbidity ratio for mortality and AMI was 0.99 (95% CI: 0.8-1.2) and 0.87 (95% CI: 0.5-1.2) respectively.
  
  
  CONCLUSIONS
  The incidence of TE and major bleeding in this unselected clinical population exceeds that of previously reported retrospective and randomized trials. Despite this, mortality is equal to that of the general population.
authors.affiliation: Department of Clinical Sciences, Malmö, Lund University, Sweden; Department of Cardiology, Skåne University Hospital, Malmö, Sweden. Electronic address: ashkan.labaf@med.lu.se.
authors.forename: Ashkan
authors.initials: A
authors.lastname: Labaf
authors.affiliation: Department of Internal Medicine, General Hospital in Sundsvall, Sundsvall, Sweden; Department of Public Health and Clinical Medicine, Umeå University, Sweden.
authors.forename: Bartosz
authors.initials: B
authors.lastname: Grzymala-Lubanski
authors.affiliation: Department of Clinical Sciences, Malmö, Lund University, Sweden; Department of Cardiology, Skåne University Hospital, Malmö, Sweden.
authors.forename: Martin
authors.initials: M
authors.lastname: Stagmo
authors.affiliation: Department of Clinical Sciences, Malmö, Lund University, Sweden.
authors.forename: Susanna
authors.initials: S
authors.lastname: Lövdahl
authors.affiliation: Department of Clinical Sciences, Malmö, Lund University, Sweden; Department of Emergency Medicine, Skåne University Hospital, Malmö, Sweden.
authors.forename: Mattias
authors.initials: M
authors.lastname: Wieloch
authors.affiliation: Department of Internal Medicine, General Hospital in Sundsvall, Sundsvall, Sweden; Department of Public Health and Clinical Medicine, Umeå University, Sweden.
authors.forename: Anders
authors.initials: A
authors.lastname: Själander
authors.affiliation: Department of Clinical Sciences, Malmö, Lund University, Sweden; Department of Coagulation disorders, Skåne University Hospital, Malmö, Sweden.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Svensson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use; D015331:Cohort Studies; D005260:Female; D006350:Heart Valve Prosthesis / Q000009:adverse effects*; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects* / Q000401:mortality; D006470:Hemorrhage / Q000209:etiology* / Q000401:mortality; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013923:Thromboembolism / Q000209:etiology* / Q000401:mortality; D014859:Warfarin / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D014859:Warfarin
keywords: Bleeding; Mechanical heart valve prostheses; Mortality; Thromboembolism