title: Telemedicine-guided, very low-dose international normalized ratio self-control in patients with mechanical heart valve implants.
abstract: OBJECTIVE
  To study in patients performing international normalized ratio (INR) self-control the efficacy and safety of an INR target range of 1.6-2.1 for aortic valve replacement (AVR) and 2.0-2.5 for mitral valve replacement (MVR) or double valve replacement (DVR).
  
  
  RESULTS
  In total, 1304 patients undergoing AVR, 189 undergoing MVR and 78 undergoing DVR were randomly assigned to low-dose INR self-control (LOW group) (INR target range, AVR: 1.8-2.8; MVR/DVR: 2.5-3.5) or very low-dose INR self-control once a week (VLO group) and twice a week (VLT group) (INR target range, AVR: 1.6-2.1; MVR/DVR: 2.0-2.5), with electronically guided transfer of INR values. We compared grade III complications (major bleeding and thrombotic events; primary end-points) and overall mortality (secondary end-point) across the three treatment groups.
  
  
  RESULTS
  Two-year freedom from bleedings in the LOW, VLO, and VLT groups was 96.3, 98.6, and 99.1%, respectively (P = 0.008). The corresponding values for thrombotic events were 99.0, 99.8, and 98.9%, respectively (P = 0.258). The risk-adjusted composite of grade III complications was in the per-protocol population (reference: LOW-dose group) as follows: hazard ratio = 0.307 (95% CI: 0.102-0.926; P = 0.036) for the VLO group and = 0.241 (95% CI: 0.070-0.836; P = 0.025) for the VLT group. The corresponding values of 2-year mortality were = 1.685 (95% CI: 0.473-5.996; P = 0.421) for the VLO group and = 4.70 (95% CI: 1.62-13.60; P = 0.004) for the VLT group.
  
  
  CONCLUSIONS
  Telemedicine-guided very low-dose INR self-control is comparable with low-dose INR in thrombotic risk, and is superior in bleeding risk. Weekly testing is sufficient. Given the small number of MVR and DVR patients, results are only valid for AVR patients.
authors.affiliation: Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany Institute of Applied Telemedicine, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, Georgstr.11 32545, Bad Oeynhausen, Germany hkoertke@hdz-nrw.de.
authors.forename: Heinrich
authors.initials: H
authors.lastname: Koertke
authors.affiliation: Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany.
authors.forename: Armin
authors.initials: A
authors.lastname: Zittermann
authors.affiliation: Institute of Applied Telemedicine, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, Georgstr.11 32545, Bad Oeynhausen, Germany.
authors.forename: Otto
authors.initials: O
authors.lastname: Wagner
authors.affiliation: Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany Institute of Applied Telemedicine, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, Georgstr.11 32545, Bad Oeynhausen, Germany.
authors.forename: Songuel
authors.initials: S
authors.lastname: Secer
authors.affiliation: Hospital Santa Anna, Catanzaro, Italy.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Sciangula
authors.affiliation: Academic City Hospital, Ludwigshafen, Germany.
authors.forename: Werner
authors.initials: W
authors.lastname: Saggau
authors.affiliation: Academic City Hospital, Ludwigshafen, Germany.
authors.forename: Falk-Udo
authors.initials: FU
authors.lastname: Sack
authors.affiliation: Mediclin Heart Institute Lahr/Baden, Lahr; University Witten-Herdecke, Faculty of Health, School of Medicine, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Ennker
authors.affiliation: Clinic for Cardiac and Vascular Surgery, Christain-Albrechts-University Kiel, Kiel, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Cremer
authors.affiliation: Azienda Ospedaliera S. Camillo Forlani, Roma, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Musumeci
authors.affiliation: Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany.
authors.forename: Jan F
authors.initials: JF
authors.lastname: Gummert
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000925:Anticoagulants / Q000008:administration & dosage*; D001021:Aortic Valve; D004334:Drug Administration Schedule; D005260:Female; D006349:Heart Valve Diseases / Q000601:surgery; D006350:Heart Valve Prosthesis / Q000009:adverse effects*; D006470:Hemorrhage / Q000139:chemically induced*; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve; D012648:Self Care / Q000379:methods; D017216:Telemedicine; D013923:Thromboembolism / Q000517:prevention & control*; D016896:Treatment Outcome; D014812:Vitamin K / Q000037:antagonists & inhibitors; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D014812:Vitamin K
keywords: Bleeding event; International normalized ratio; Mechanical heart valve replacement; Oral anticoagulation; Thrombotic event; Vitamin K antagonists