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Prosthetic valves in adult patients with congenital heart disease: Rationale and design of the Dutch PROSTAVA study

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Abstract

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.

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Financial support

This study is supported by a grant from the Netherlands Heart Foundation to P.G.P. (2009B013).

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Authors and Affiliations

  1. Department of Cardiology, University of Groningen, University Medical Center Groningen, PO Box 30.001, 9700, RB, Groningen, the Netherlands

    H. G. Freling, Y. J. van Slooten, J. P. van Melle & P. G. Pieper

  2. Departments of Radiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands

    H. G. Freling & T. P. Willems

  3. Departments of Cardiothoracic Surgery, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands

    Y. J. van Slooten

  4. Departments of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands

    H. L. Hillege

  5. Department of Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands

    B. J. M. Mulder

  6. Department of Cardiology, University Medical Center Nijmegen St. Radboud, Radboud University Nijmegen, Nijmegen, the Netherlands

    A. P. J. van Dijk

  7. Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands

    M. C. Post

  8. Department of Cardiology, University Medical Centre Utrecht, Utrecht, the Netherlands

    G. Tj. Sieswerda

  9. Department of Cardiology, Leiden University Medical Center, University of Leiden, Leiden, the Netherlands

    M. R. M. Jongbloed

  10. Interuniversity Cardiology Institute of the Netherlands (ICIN), Utrecht, the Netherlands

    H. G. Freling & Y. J. van Slooten

Authors
  1. H. G. Freling
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  2. Y. J. van Slooten
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  3. J. P. van Melle
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  4. B. J. M. Mulder
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  5. A. P. J. van Dijk
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  7. M. C. Post
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  8. G. Tj. Sieswerda
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  9. M. R. M. Jongbloed
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  11. P. G. Pieper
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Consortia

On behalf of the PROSTAVA investigators

Corresponding author

Correspondence to P. G. Pieper.

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Freling, H.G., van Slooten, Y.J., van Melle, J.P. et al. Prosthetic valves in adult patients with congenital heart disease: Rationale and design of the Dutch PROSTAVA study. Neth Heart J 20, 419–424 (2012). https://doi.org/10.1007/s12471-012-0308-4

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  • DOI: https://doi.org/10.1007/s12471-012-0308-4

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