BACKGROUND: The declining use of mechanical valves is in large part due to the risk associated with lifelong anticoagulation. However, there is a paucity of data specifically addressing this risk in non-elderly adults. The aim of this study was to examine the long-term incidence, severity and impact of bleeding events after mechanical aortic valve replacement (AVR) in these patients.
METHODS AND RESULTS: From 2000 to 2015, 540 consecutive adults < 65 years (mean age 53±8 years, 67% male) underwent elective isolated mechanical AVR. Patients with infective endocarditis, associated procedures and previous cardiac surgeries were excluded. Eighty-nine percent had a target INR of 2.5-3.5 and 25% were also taking aspirin at the time of last follow-up. Only 10.5% of patients used home anticoagulation management. Primary outcomes of interest were hemorrhagic events during follow-up and quality of life (QoL) using a valve-specific questionnaire. Secondary outcomes were survival and freedom from major adverse prosthetic events (MAPE). Bleeding events were reported using the International Society of Thrombosis and Hemostasis definitions. Mean follow-up was 11.3 ± 4.5 years and was 96% complete. Early mortality was 2% (n=11). A total of 48 patients experiencing major bleeding events were reported (8.9%), of which 17% (n=8) had recurrences. Freedom from major bleeding events at 5, 10 and 15 years was 96±2%, 92±2% and 88±4%, respectively (Figure 1). Overall, 40% of major bleeding events were digestive (n=19), 29% were intracranial (n=14), 8% were genital (n=4) and 6% were pericardial (n=3). Major bleeding-associated mortality was 6.3% (n=3), all of which were intracranial hemorrhages. Overall QoL outcomes were satisfactory late after mechanical AVR (Table 1): 92% of patients said that the valve sound never/rarely bothered them and 86% would make the same decision to have surgery with a mechanical valve. Late actuarial survival at 5,10 and 15 years was 93±2%, 89±3% and 79±5%, respectively. Actuarial freedom from thromboembolic events at 15 years was 82±5% and actuarial freedom from reoperation at 15 years was 93±3%. Reoperation associated mortality was 11% (n=3).
CONCLUSION: These findings suggest that the linearized rate of major bleeding events in non-elderly adults after mechanical is in the 1%/patient-year range. Nevertheless, mortality associated with major bleeding is low. Overall quality of life later after mechanical AVR is satisfactory despite lifelong oral anticoagulation. This study helps better define long-term outcomes in this patient population in order to better inform patients about surgical options.