Daniela Poli1, Emilia Antonucci2, Vittorio Pengo3, Ludovica Migliaccio2, Sophie Testa4, Corrado Lodigiani5, Nadia Coffetti6, Roberto Facchinetti7, Giuseppina Serricchio8, Pietro Falco9, Catello Mangione10, Serena Masottini11, Lucia Ruocco12, Raffaele De Caterina13, Gualtiero Palareti2. 1. Thrombosis Centre, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy. Electronic address: polida@aou-careggi.toscana.it. 2. Arianna Anticoagulazione Foundation, Bologna, Italy. 3. Department of Cardiac Thoracic and Vascular Sciences, Thrombosis Centre, University of Padova, Italy. 4. Haemostasis and Thrombosis Centre, Hospital of Cremona Italy. 5. Humanitas Research Hospital, IRCCS Rozzano-Milano, Italy. 6. Immunoematologia e Medicina Trasfusionale Azienda Ospedaliera Bolognini, ASST Bergamo Est, Seriate, Italy. 7. Laboratorio Analisi (AOUI) Ospedale Civile Maggiore Di Borgo Trento, Verona, Italy. 8. Centro TAO PO Cantù, ASST Lariana, Como, Italy. 9. Poliambulatorio Specialistico Medical Pontino, Latina, Italy. 10. Servizio Immunotrasfusionale Ospedale "Santa Caterina Novella", Galatina (Le), Italy. 11. Centro per la prevenzione, diagnosi e trattamento delle malattie tromboemboliche- Asl 8- Cagliari, Italy. 12. Ambulatorio Antitrombosi CAT-TAO AOU Pisana, Pisa, Italy. 13. Institute of Cardiology and Center of Excellence on Aging - "G. d'Annunzio" University - Chieti, Italy.
Abstract
BACKGROUND: Patients with a mechanical prosthetic heart valve implantation need to be treated with a vitamin K antagonist (VKA) due to a substantially high risk of thromboembolism. In this study we report data on patients with mechanical heart valves (MV), with the aim of evaluating the thromboembolic risk in relation to the type and site of implantation, quality of anticoagulation and risk factors associated with thromboembolism. METHODS: Observational retrospective multicenter study among Centers affiliated to the Italian Federation of Anticoagulation Clinics (FCSA) on patients with MV implanted after 1990 and followed for the management of anticoagulation. RESULTS: We analyzed 2357 patients with mechanical heart valves (55.2% males), followed for 24,081 years. During the follow-up, 164 thromboembolic events (0.67/100 pt-yrs) and 243 major bleedings (1.0/100 pt-yrs) occurred. The median Time in Therapeutic Range (TTR), calculated in all intended INR classes, was 60% (IQR 47-74%). The rates of thrombotic events were significantly higher in patients intended to stay at therapeutic ranges >INR 2.0-3.0. The presence of atrial fibrillation, history of thromboembolism and of mitral prosthesis were independently associated with thromboembolism. However, a bad quality of anticoagulation (TTR <47%, 25°percentile of our population) was not correlated with thromboembolism. CONCLUSIONS: A low rate of bleeding and thromboembolic events in patients with mechanical heart valves were found, despite the sub-optimal anticoagulation control. The thromboembolic risk was not associated with the low TTR.
BACKGROUND:Patients with a mechanical prosthetic heart valve implantation need to be treated with a vitamin K antagonist (VKA) due to a substantially high risk of thromboembolism. In this study we report data on patients with mechanical heart valves (MV), with the aim of evaluating the thromboembolic risk in relation to the type and site of implantation, quality of anticoagulation and risk factors associated with thromboembolism. METHODS: Observational retrospective multicenter study among Centers affiliated to the Italian Federation of Anticoagulation Clinics (FCSA) on patients with MV implanted after 1990 and followed for the management of anticoagulation. RESULTS: We analyzed 2357 patients with mechanical heart valves (55.2% males), followed for 24,081 years. During the follow-up, 164 thromboembolic events (0.67/100 pt-yrs) and 243 major bleedings (1.0/100 pt-yrs) occurred. The median Time in Therapeutic Range (TTR), calculated in all intended INR classes, was 60% (IQR 47-74%). The rates of thrombotic events were significantly higher in patients intended to stay at therapeutic ranges >INR 2.0-3.0. The presence of atrial fibrillation, history of thromboembolism and of mitral prosthesis were independently associated with thromboembolism. However, a bad quality of anticoagulation (TTR <47%, 25°percentile of our population) was not correlated with thromboembolism. CONCLUSIONS: A low rate of bleeding and thromboembolic events in patients with mechanical heart valves were found, despite the sub-optimal anticoagulation control. The thromboembolic risk was not associated with the low TTR.