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Prognosis after aortic valve replacement with St. Jude Medical bileaflet prostheses: impact on outcome of varying thromboembolic and bleeding hazards

J.J.M. Takkenberga,1, J.P.A. Puvimanasinghe1,2, L.A. van Herwerden1, E.W. Steyerberg2, M.J.C. Eijkemans2, J.D.F Habbema2 and A.J.J.C. Bogers1

a Department of Cardio-thoracic Surgery, Department of Public Health, Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands
b Center for Clinical Decision Sciences, Department of Public Health, Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands

a Correspondence: Johanna J.M. Takkenberg, MD, Department of Cardio-thoracic Surgery, Bd162, Erasmus Medical Center Rotterdam, P.O. Box 2040, NL-3000CA, Rotterdam, The Netherlands.

Abstract

Aims Prognosis after aortic valve replacement (AVR) with mechanical prostheses depends on multiple inter-related factors. Investigation into these factors is complicated by limited knowledge on outcome after AVR and by the varying therapeutic ranges of International Normalized Ratio employed worldwide. Meta-analysis was combined with microsimulation to calculate evidence-based, age-specific outcomes after AVR with St. Jude Medical (SJM) prostheses (St. Jude Medical, Inc., St. Paul, MN, U.S.A.).

Method and results Eight studies were included in a meta-analysis of published results of primary isolated AVR with SJM prostheses (2986 patients, 16,163 patient-years) in order to estimate the hazard of postoperative valve-related events. Using microsimulation, calculated life expectancy and event-free life expectancy were 22 and 16 years in males aged 35 years, and 7 and 5 years in males aged 75 years, respectively. Calculated lifetime risks for thromboembolic and bleeding events were 22% and 15% in males aged 35 years, and 7% and 37% in males aged 75 years, respectively. Varying thromboembolic and bleeding hazards resulted in considerable shifts in lifetime risks and deaths associated with these events.

Conclusion Meta-analysis combined with microsimulation is a powerful tool with which to calculate reliable estimates of long-term prognosis, and allows detailed insight into the occurrence of valve-related events. Thromboembolism and bleeding occur frequently after AVR with mechanical prostheses and have an important impact on survival. Optimal control of International Normalized Ratio is therefore of utmost importance.

Key Words: Aortic valve replacement • bleeding • mechanical valves • prognostic modelling • thromboembolism

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