title: Long-term self-management of anticoagulation therapy after mechanical heart valve replacement in outside trial conditions.
abstract: In this investigation, we hypothesize that quality of oral anticoagulation (OA) and long-term outcome after mechanical heart valve (MHV) replacement with self-management (Self-M) of OA is superior to conventional anticoagulation treatment (Conv-T), even in outside trial conditions. One hundred sixty patients (78.8% aortic valve replacements) were trained in international normalized ratio Self-M and 260 patients (86.2% aortic valve replacements) preferred Conv-T. Mean follow-up was 8.6 ± 2.1 years, representing 3612 patient-years. During follow-up, 37.2% bleedings and 10.6% thromboembolic events were recorded in the Self-M group versus 39.6% bleedings (P = 0.213) and 15.4% thromboembolic events (P = 0.064) in the Conv-T group. Serious adverse events were significantly lower in the Self-M group [grade III bleeding events causing disability or death: 0 versus 4.6% (P = 0.03); grade III thromboembolic events: 0.6 versus 5.0% (P = 0.011)]. Patients with Self-M were significantly more satisfied with their OA management and their quality of life (P < 0.001). Actuarial survival after 1, 5 and 10 years was 100, 99 and 97 with Self-M and 100, 95 and 81% with Conv-T, respectively (P < 0.001). Univariate risk factors for mortality were age (P = 0.008), type of operation (P = 0.021) and conventional OA (P < 0.001). In multivariate analysis, only conventional OA reached significance (P < 0.001). We conclude that in a routine setting under outside trial conditions Self-M of OA improves long-term outcome and treatment quality.
authors.affiliation: Department of Cardiac Surgery, University Hospital Grosshadern, Ludwig-Maximilians-University, Munich, Germany. helmut.mair@med.uni-muenchen.de
authors.forename: Helmut
authors.initials: H
authors.lastname: Mair
authors.forename: Jörg
authors.initials: J
authors.lastname: Sachweh
authors.forename: Ralf
authors.initials: R
authors.lastname: Sodian
authors.forename: Paolo
authors.initials: P
authors.lastname: Brenner
authors.forename: Michael
authors.initials: M
authors.lastname: Schmoeckel
authors.forename: Christoph
authors.initials: C
authors.lastname: Schmitz
authors.forename: Bruno
authors.initials: B
authors.lastname: Reichart
authors.forename: Sabine
authors.initials: S
authors.lastname: Daebritz
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000601:surgery; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011183:Postoperative Complications / Q000517:prevention & control*; D011184:Postoperative Period; D011788:Quality of Life; D012189:Retrospective Studies; D012648:Self Care / Q000379:methods*; D011795:Surveys and Questionnaires; D013927:Thrombosis / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants