Aortic Valve Replacement With the St. Jude Medical Prosthesis and Fixed Dose Anticoagulation

Abstract

Over a 10-year period, between 1986 and 1996, 865 patients underwent primary aortic valve replacement (AVR) with the St. Jude Medical mechanical prosthesis. Patients who had undergone valve replacement with a different type of prosthesis previously were excluded from this study. Patient age ranged from 11 to 79 years. The mean age was 42.9 +/- 14.54. The gender distribution was 396 men (45.8%) and 469 women (54.2%). All patients received 2.5 mg/day Coumadin after extubation. A combination of the antiaggregant therapy (Dypridamole 3X 75 mg/day, Asprine 100 mg/day) was added after removal of the chest tubes. The dosage of Coumadin was maintained constant regardless of the prothrombin time (PT) or cardiac rhythm. There were 101 valve-related complications (4.2% per patient year [ppy]) occurring in the late follow-up period. Of these complications; 38 were anticoagulant-related hemorrhage (1.58% ppy), 3 were paravalvular leak (0.12% ppy), and 36 were thromboembolism (1.4% ppy). There were 24 reoperations (0.99% ppy) and 17 late deaths. The linearized late mortality rate was 0.7% ppy. Long-term survival estimates at 5 and 10 years were 97.14 +/- 0.82% and 94.86 +/- 1.54%, respectively. We conclude from the data that the St. Jude Medical valve may allow the use of a low level of anticoagulation. This study shows that fixed dose oral anticoagulation does not increase the rate of thromboembolism in patients with the St. Jude aortic valve. This protocol does not result in reduction of bleeding complications, however.

Single‐Center Experience with the Bicarbon Bileaflet Prosthetic Heart Valve in Japan

“…The linearized rate of mechanical valve thrombosis was between 0.04% and 0.39% per patient‐year (8,14,21–25). Paravalvular leak occurred at a rate of 0.1% to 0.92% per patient‐year (8,21,24,26) and endocarditis at the rate of 0.1% to 0.53% per patient‐year (7,14,21,23). The reported differences might come from the terms of follow‐up, population of the patients studied, or from prosthetic valve characteristics.…”

“…The causes of reoperation included thrombosed prosthetic valves, pannus formation restricting prosthetic valve function, and paravalvular leaks with or without infective endocarditis. The linearized rate of mechanical valve thrombosis was between 0.04% and 0.39% per patient-year (8,14,(21)(22)(23)(24)(25). Paravalvular leak occurred at a rate of 0.1% to 0.92% per patient-year (8,21,24,26) and endocarditis at the rate of 0.1% to 0.53% per patient-year (7,14,21,23).…”

Oral anticoagulation and risk of death: a medical record linkage study

“…In order to minimise complications, a combination treatment of dipyridamole, aspirin, and a fixed low daily dose of warfarin has been suggested for patients with a heart valve prosthesis. 4 5 Furthermore, the beneficial effect of anticoagulation after fitting a biological replacement for an aortic valve has been questioned 6…”

Comparison of mechanical and bioprosthesis valve in over 70-year-old patients with aortic valve replacement: mechanical - bioprosthesis valve

“…Düşük mortalite, düşük trombojenite, düşük kapak komplikasyonları ile st. Jude mekanik kapaklar güvenilir bulunmuş ve mortalite oranlarının düşük olması bu kapakların birçok merkezde yaygın kullanılmasını sağlamıştır (14). Bazı merkezlerde ise st. Jude mekanik kapak takılan hastalarda düşük dozda antikoagülan tedavi ile tromboemboliye karşı yeterli koruma sağlandığı ve bu hastalarda INR'nin yüksek olduğu hastalara göre tromboembolik komplikasyon oranlarında çok az artış olmasına karşın, kanama oranlarında önemli derecede azalma olduğu gösterilmiştir (15). Bizim çalışmamızda da mekanik kapak olarak bütün hastalara St. Jude kapak kullanılmış olup; bir hastada yetersiz warfarin kullanımına bağlı serebrovasküler olay gelişmiştir.…”