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Netherlands Heart Journal

, Volume 20, Issue 10, pp 419–424 | Cite as

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

  • H. G. Freling
  • Y. J. van Slooten
  • J. P. van Melle
  • B. J. M. Mulder
  • A. P. J. van Dijk
  • H. L. Hillege
  • M. C. Post
  • G. Tj. Sieswerda
  • M. R. M. Jongbloed
  • T. P. Willems
  • P. G. PieperEmail author
  • On behalf of the PROSTAVA investigators
Special Article – E-learning

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.

Keywords

Congenital heart disease Prosthesis-patient mismatch Prosthetic heart valve Valvular heart disease Functional outcome Quality of life 

Notes

Financial support

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

References

  1. 1.
    Marelli AJ, Mackie AS, Ionescu-Ittu R, et al. Congenital heart disease in the general population: changing prevalence and age distribution. Circulation. 2007;115:163–72.PubMedCrossRefGoogle Scholar
  2. 2.
    Drenthen W, Boersma E, Balci A, et al. Predictors of pregnancy complications in women with congenital heart disease. Eur Heart J. 2010;31:2124–32.PubMedCrossRefGoogle Scholar
  3. 3.
    Rahimtoola SH. Choice of prosthetic heart valve in adults an update. J Am Coll Cardiol. 2010;55:2413–26.PubMedCrossRefGoogle Scholar
  4. 4.
    Tasca G, Mhagna Z, Perotti S, et al. Impact of prosthesis-patient mismatch on cardiac events and midterm mortality after aortic valve replacement in patients with pure aortic stenosis. Circulation. 2006;113:570–6.PubMedCrossRefGoogle Scholar
  5. 5.
    Karamlou T, Jang K, Williams WG, et al. Outcomes and associated risk factors for aortic valve replacement in 160 children: a competing-risks analysis. Circulation. 2005;112:3462–9.PubMedCrossRefGoogle Scholar
  6. 6.
    Masuda M, Kado H, Ando Y, et al. Intermediate-term results after the aortic valve replacement using bileaflet mechanical prosthetic valve in children. Eur J Cardiothorac Surg. 2008;34:42–7.PubMedCrossRefGoogle Scholar
  7. 7.
    Oosterhof T, Meijboom FJ, Vliegen HW, et al. Long-term follow-up of homograft function after pulmonary valve replacement in patients with tetralogy of Fallot. Eur Heart J. 2006;27:1478–84.PubMedCrossRefGoogle Scholar
  8. 8.
    Akins CW, Miller DC, Turina MI, et al. Guidelines for reporting mortality and morbidity after cardiac valve interventions. J Thorac Cardiovasc Surg. 2008;135:732–8.PubMedCrossRefGoogle Scholar
  9. 9.
    Pibarot P, Dumesnil JG. Hemodynamic and clinical impact of prosthesis-patient mismatch in the aortic valve position and its prevention. J Am Coll Cardiol. 2000;36:1131–41.PubMedCrossRefGoogle Scholar
  10. 10.
    Pibarot P, Dumesnil JG. Prosthesis-patient mismatch in the mitral position: old concept, new evidences. J Thorac Cardiovasc Surg. 2007;133:1405–8.PubMedCrossRefGoogle Scholar
  11. 11.
    Loup O, von Weissenfluh C, Gahl B, et al. Quality of life of grown-up congenital heart disease patients after congenital cardiac surgery. Eur J Cardiothorac Surg. 2009;36:105–11.PubMedCrossRefGoogle Scholar
  12. 12.
    Moons P, Van Deyk K, De Geest S, et al. Is the severity of congenital heart disease associated with the quality of life and perceived health of adult patients? Heart. 2005;91:1193–8.PubMedCrossRefGoogle Scholar
  13. 13.
    Pieper PG, Balci A, Van Dijk AP. Pregnancy in women with prosthetic heart valves. Neth Heart J. 2008;16:406–11.PubMedCrossRefGoogle Scholar
  14. 14.
    Pieper PG. Expected and unexpected cardiac problems during pregnancy. Neth Heart J. 2008;16:403–5.PubMedCrossRefGoogle Scholar
  15. 15.
    Masuda M, Kado H, Tatewaki H, et al. Late results after mitral valve replacement with bileaflet mechanical prosthesis in children: evaluation of prosthesis-patient mismatch. Ann Thorac Surg. 2004;77:913–7.PubMedCrossRefGoogle Scholar
  16. 16.
    Tasca G, Brunelli F, Cirillo M, et al. Impact of valve prosthesis-patient mismatch on left ventricular mass regression following aortic valve replacement. Ann Thorac Surg. 2005;79:505–10.PubMedCrossRefGoogle Scholar
  17. 17.
    Waterbolk TW, Hoendermis ES, den Hamer IJ, et al. Pulmonary valve replacement with a mechanical prosthesis. Promising results of 28 procedures in patients with congenital heart disease. Eur J Cardiothorac Surg. 2006;30:28–32.PubMedCrossRefGoogle Scholar
  18. 18.
    Stulak JM, Dearani JA, Burkhart HM, et al. The increasing use of mechanical pulmonary valve replacement over a 40-year period. Ann Thorac Surg. 2010;90:2009–15.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Media / Bohn Stafleu van Loghum 2012

Authors and Affiliations

  • H. G. Freling
    • 1
    • 2
    • 10
  • Y. J. van Slooten
    • 1
    • 3
    • 10
  • J. P. van Melle
    • 1
  • B. J. M. Mulder
    • 5
  • A. P. J. van Dijk
    • 6
  • H. L. Hillege
    • 4
  • M. C. Post
    • 7
  • G. Tj. Sieswerda
    • 8
  • M. R. M. Jongbloed
    • 9
  • T. P. Willems
    • 2
  • P. G. Pieper
    • 1
    Email author
  • On behalf of the PROSTAVA investigators
  1. 1.Department of CardiologyUniversity of Groningen, University Medical Center GroningenGroningenthe Netherlands
  2. 2.Departments of RadiologyUniversity of Groningen, University Medical Center GroningenGroningenthe Netherlands
  3. 3.Departments of Cardiothoracic SurgeryUniversity of Groningen, University Medical Center GroningenGroningenthe Netherlands
  4. 4.Departments of EpidemiologyUniversity of Groningen, University Medical Center GroningenGroningenthe Netherlands
  5. 5.Department of CardiologyAcademic Medical Centre, University of AmsterdamAmsterdamthe Netherlands
  6. 6.Department of CardiologyUniversity Medical Center Nijmegen St. Radboud, Radboud University NijmegenNijmegenthe Netherlands
  7. 7.Department of CardiologySt. Antonius HospitalNieuwegeinthe Netherlands
  8. 8.Department of CardiologyUniversity Medical Centre UtrechtUtrechtthe Netherlands
  9. 9.Department of CardiologyLeiden University Medical Center, University of LeidenLeidenthe Netherlands
  10. 10.Interuniversity Cardiology Institute of the Netherlands (ICIN)Utrechtthe Netherlands

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