title: Reduction of mechanical heart valve thrombosis through a clinical audit.
abstract: OBJECTIVE
  Patients with mechanical heart valves implanted at four cardiothoracic centers were followed up in a hospital in Eastern India. Despite successful surgery and regular hospital visits, long-term survival was compromised by anticoagulation-related complications.
  
  
  METHODS
  Systematic analysis revealed under-anticoagulation in most patients. Thrombosis risk in 80 patients on regular follow up from 1989 to 1997 was 8.68 per 100 patient years (pt-yr). The incidence of both thrombotic and bleeding complications was reported as less than two per 100 pt-yr, when prothrombin time was consistently in the range of INR 2.5 to 3.9. In targeting this low event rate, impediments to optimum anticoagulation in the local set-up were identified. International Normalized Ratio (INR) was introduced to report prothrombin time (PT). Patients and doctors were educated about drug and diet interactions with oral anticoagulants (OAC) and the early features of valve thrombosis. Treatment protocols were evolved. The impact of the remedial measures was studied in 81 patients (64 old, 17 new) over a total of 254 pt-yr of follow up, from 1998 to 2001.
  
  
  RESULTS
  Thrombosis risk was reduced from 8.68 to 5.12 per 100 pt-yr, while non-fatal bleeding events increased from 0.28 to 1.96 per 100 pt-yr. Due to early recognition of occlusive prosthetic valve thrombosis and institution of fibrinolytic therapy, fatal events were reduced from 3.8 per 100 pt-yr to none for four consecutive years (statistically significant at 99% CI).
  
  
  CONCLUSIONS
  The clinical audit proved to be a valuable tool for understanding the problems in health care delivery, and bringing about improvement.
authors.affiliation: Department of Cardiology, Tata Main Hospital, Jamshedpur, India. vbharat@satyam.net.in
authors.forename: V
authors.initials: V
authors.lastname: Bharat
authors.forename: N K
authors.initials: NK
authors.lastname: Das
authors.forename: B
authors.initials: B
authors.lastname: Mohanty
authors.forename: A C
authors.initials: AC
authors.lastname: Jha
authors.forename: S C
authors.initials: SC
authors.lastname: Chawla
authors.forename: B
authors.initials: B
authors.lastname: Dash
authors.forename: R
authors.initials: R
authors.lastname: Mohanty
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D001021:Aortic Valve / Q000503:physiopathology / Q000601:surgery; D001705:Bioprosthesis; D016022:Case-Control Studies; D016001:Confidence Intervals; D005260:Female; D006349:Heart Valve Diseases / Q000175:diagnosis / Q000601:surgery; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects* / Q000379:methods; D006801:Humans; D007194:India; D008297:Male; D008485:Medical Audit; D008875:Middle Aged; D008943:Mitral Valve / Q000503:physiopathology / Q000601:surgery; D011183:Postoperative Complications / Q000401:mortality / Q000517:prevention & control*; D011475:Prosthesis Failure; D012016:Reference Values; D018570:Risk Assessment; D016019:Survival Analysis; D013923:Thromboembolism / Q000401:mortality / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants