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

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 prosthesispatient mismatch. Other evaluations are medical history, physical examination, echocardiography, MRI, rhythm monitoring and laboratory evaluation (including NT-proBNP).

Quality of Life Among Patients With Congenital Heart Disease After Valve Replacement

“…The rationale and design of the PROSTAVA study have been previously descripted. 10 Briefly, data were retrospectively collected on demography and medical history by patient record. Data on echocardiography, cardiac magnetic resonance (CMR), blood testing, and exercise testing were collected as part of routine clinical care.…”

“…In addition, we set out to investigate possible associations with QOL and the influence of valve position on QOL, using the PROSTheses in Adult congenital heart VAlve disease (PROSTAVA) cohort. 10…”

Aortic valve prosthesis–patient mismatch and exercise capacity in adult patients with congenital heart disease

“…The prevalence and clinical consequences of PPM in adults with CHD (ACHD) have not been investigated. The PROST heses in A dult congenital heart VA lve disease (PROSTAVA) study5 was, therefore, set up to investigate the relationship between valve prosthesis-related characteristics and exercise capacity in ACHD. Patients for the PROSTAVA study were selected from the Dutch CON genital COR vitia (CONCOR) national registry6 that aims to facilitate research on ACHD by registering all ACHD on a voluntary basis.…”

NT-proBNP and exercise capacity in adult patients with congenital heart disease and a prosthetic valve: a multicentre PROSTAVA study

“…The PROSTAVA study was conducted to investigate the relationship between characteristics of valve prostheses (type, labelled size, location) and functional outcome in ACHD patients. Study design and rationale were previously described [ 11 ]. Briefly, patients with a prosthetic heart valve (homografts, heterografts and mechanical valves in aortic, mitral, pulmonary or tricuspid position) registered in the CONCOR database and followed in one of the six PROSTAVA centres were eligible.…”