1. Prosthetic valves in adult patients with congenital heart disease: Rationale and design of the Dutch PROSTAVA study
- Author
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Freling, H.G., Slooten, Y.J. van, Melle, J.P. van, Mulder, B.J.M., Dijk, A.P.J. van, Hillege, H.L., Post, M.C., Sieswerda, G.T., Jongbloed, M.R.M., Willems, T.P., Pieper, P.G., PROSTAVA Investigators, Life Course Epidemiology (LCE), Cardiovascular Centre (CVC), Groningen Kidney Center (GKC), Amsterdam Cardiovascular Sciences, and Cardiology
- Subjects
Quality of life ,Pediatrics ,medicine.medical_specialty ,Heart disease ,IMPACT ,MECHANICAL PROSTHESIS ,MISMATCH ,Physical examination ,CHILDREN ,Special Article – E-learning ,QUALITY-OF-LIFE ,medicine ,Medical history ,POSITION ,Congenital heart disease ,Pregnancy ,medicine.diagnostic_test ,Cardiovascular diseases [NCEBP 14] ,business.industry ,Incidence (epidemiology) ,MORTALITY ,valvular heart disease ,Prosthesis-patient mismatch ,WOMEN ,Functional outcome ,medicine.disease ,Valvular heart disease ,Surgery ,REPLACEMENT ,PREGNANCY ,Prosthetic heart valve ,Observational study ,Cardiology and Cardiovascular Medicine ,business - Abstract
Item does not contain fulltext BACKGROUND: Data on long-term complications in adult patients with congenital heart disease (ACHD) and a prosthetic valve are scarce. Moreover, the influence of prosthetic valves on quality of life (QoL) and functional outcome in ACHD patients with prosthetic valves has not been studied. OBJECTIVES: The primary objective of the PROSTAVA study is to investigate the relation between prosthetic valve characteristics (type, size and location) and functional outcome as well as QoL in ACHD patients. The secondary objectives are to investigate the prevalence and predictors of prosthesis-related complications including prosthesis-patient mismatch. METHODS: The PROSTAVA study, a multicentre cross-sectional observational study, will include approximately 550 ACHD patients with prosthetic valves. Primary outcome measures are maximum oxygen uptake during cardiopulmonary exercise testing and QoL. Secondary outcomes are the prevalence and incidence of valve-related complications including prosthesis-patient mismatch. Other evaluations are medical history, physical examination, echocardiography, MRI, rhythm monitoring and laboratory evaluation (including NT-proBNP). IMPLICATIONS: Identification of the relation between prosthetic valve characteristics in ACHD patients on one hand and functional outcome, QoL, the prevalence and predictors of prosthesis-related complications on the other hand may influence the choice of valve prosthesis, the indication for more extensive surgery and the indication for re-operation.
- Published
- 2012
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