Table 1PICO characteristics of review question

Population

Inclusion:

Adults aged 18 years and over with diagnosed heart valve disease and no current indication for intervention, stratified by the severity of valve disease as follows:

  • Mild
  • Moderate
  • Severe
Severity assessed by echo and rated as per The British Society of Echocardiography. Other definitions will be accepted and downgraded for indirectness if appropriate.

Exclusion:

Children aged less than 18 years.

Adults with congenital heart disease (excluding bicuspid aortic valves).

Tricuspid stenosis and pulmonary valve disease.

People who have had prior heart valve repair or replacement (transcatheter or surgical).

Interventions

Any of the following assessment strategies used for monitoring purposes, followed by appropriate valve intervention, in the specified population:

Biomarkers (alone or in combination with echo):

  • BNP (B-type natriuretic peptide)
  • NT-proBNP (N-terminal prohormone brain natriuretic peptide)
Imaging:
  • Echocardiography
  • CT (alone or in combination with echo)
  • CMR (cardiovascular magnetic resonance; alone or in combination with echo)
Patient reported outcome measures (PROMS; alone or in combination with echo), including:
  • EuroQol
  • Minnesota Living With Heart Failure Questionnaire (MLHFQ)
  • Veterans Specific Activity Questionnaire
Other methods:
  • Electrocardiogram (ECG) (alone or in combination with echo)
  • Clinical review only (no specific tests performed, as defined by the study authors)
  • Exercise testing (for example Bruce protocol; alone or in combination with echo)
Different frequencies of the tests used for monitoring will be considered as separate interventions. Therefore, we will include studies comparing different frequencies of the same or different interventions.

Frequency will be categorised into the following groups:

  • More frequently than once a year (e.g. every 3 or 6 months)
  • Once a year
  • Less frequently than once a year (e.g. every 2, 3 or 5 years)
Each monitoring test is a different strata and each frequency is a sub-analysis for each test.

Comparisons

Other active comparator listed above

No monitoring (for example, tests only performed if new symptoms emerge/symptoms worsen)

OutcomesPrimary outcomes:
  • All-cause mortality
  • Cardiac mortality
  • Health-related quality of life (any validated measure)
  • Hospitalisation for heart failure or other cardiac reason (e.g., for syncope in severe AS)
Secondary outcomes:
  • New-onset atrial fibrillation
If data are available, follow-up will be reported as a first preference at :
  • 12 months for mild and moderate valve disease
  • 6 months for severe valve disease.
Where multiple time-points are reported within a single study, only the time-point closest to that stated above will be extracted.
Study design

Randomised controlled trials (RCTs) and systematic reviews of RCTs. Published NMAs and IPDs will be considered for inclusion.

If insufficient evidence is found from RCTs, non-randomised studies will be considered for inclusion.

Important confounders NRS must be adjusted for:

  • Coronary artery disease
  • Aortopathy in aortic valve disease

From: Evidence review for monitoring of people with heart valve disease and no current indication for intervention

Cover of Evidence review for monitoring of people with heart valve disease and no current indication for intervention
Evidence review for monitoring of people with heart valve disease and no current indication for intervention: Heart valve disease presenting in adults: investigation and management: Evidence review G.
NICE Guideline, No. 208.
National Guideline Centre (UK).
Copyright © NICE 2021.

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