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Economic analysis of bleeding and thromboembolic sequelae after heart valve replacement (GELIA 7)

E. Müller* and R. Bergemann GELIA Study Group

Institute for Medical Outcome Research, Lorrach, Germany

* Correspondence: Dr. Elvira Müller, MPH, Institute for Medical Outcome Research, Herrenstr. 4, D-79539 Lörrach, Germany.

Abstract

Aims To conduct an economic analysis of the coagulation-related complications bleeding and thromboembolism following heart valve replacement.

Method and results: Incidences of thromboembolic and bleeding events and subtypes in the German Experience with Low Intensity Anticoagulation (GELIA) study were determined. Based on these data, stroke incidences in a hypothetical cohort of 10,000 patients were calculated over a period of 10 years. Associated lifetime costs were assigned in order to estimate the economic burden of stroke. A cost-effectiveness ratio was estimated for patient self-management of anticoagulation. In the GELIA study severe thromboembolic and bleeding complications occurred at rates of 0·45% and 2·62% per patient-year, respectively. Within the thromboembolic complications stroke was the most common (62%), whereas bleeding events were dominated by gastrointestinal bleeds (38%). For 10,000 patients, costs associated with stroke management amounted to DM26 million for thromboembolic and DM54 million for bleeding events within 10 years. In the GELIA study, patient self-management reduced the incidence of severe complications by 30%. An evaluation of self-management for 5000 patients yielded a cost-effectiveness ratio of DM105,000 per life-year gained.

Conclusion Major differences exist between bleeding and thromboembolic events with respect to incidence, subtype and related costs. Strokes due to bleeding exert a higher economic burden than do thromboembolic strokes. The incidence of lethal strokes may be reduced by patient self-management at an acceptable cost-effectiveness ratio.

Key Words: Bleeding • cost-effectiveness ratio • economical aspects • heart valve replacement • thromboembolism

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