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Cover of Evidence review for monitoring in people with repaired or replaced heart valves

Evidence review for monitoring in people with repaired or replaced heart valves

Heart valve disease presenting in adults: investigation and management

Evidence review K

NICE Guideline, No. 208

.

London: National Institute for Health and Care Excellence (NICE); .
ISBN-13: 978-1-4731-4301-2

1. Monitoring

1.1. Review question: What is the most clinically and cost-effective frequency of echocardiography or clinical review for monitoring in adults with repaired or replaced heart valves?

1.2. Introduction

Repaired or replaced heart valves may fail or degenerate, developing progressive clinical and haemodynamic consequences that lead to a need for reintervention. However, the progression to a need for reintervention is usually slow and predictable. It is important to determine the most clinically and cost-effective frequency of echocardiography or clinical review for monitoring of repaired or replaced heart valves.

1.3. PICO table

For full details see the review protocol in Appendix A:.

Table 1. PICO characteristics of review question.

Table 1

PICO characteristics of review question.

1.4. Clinical evidence

1.4.1. Included studies

Searches were performed for both randomised controlled trials and observational studies matching the protocol. However, no relevant clinical studies comparing different frequencies of echocardiography monitoring following valve intervention were identified for any of the listed strata.

One retrospective audit of the follow-up practice of those that had undergone surgical heart valve repair or replacement at a UK tertiary centre was identified,1 which compared practice at the centre with existing European guidelines. Although mortality between those with yearly follow-up and those without yearly follow-up could be calculated from the information presented, no adjustment was performed for any confounding factors and baseline characteristics within the two groups were not reported. Therefore this study was not included in the review but was noted as a relevant source concerning current practice for monitoring of those with repaired or replaced valves in the UK.

See also the study selection flow chart in Appendix C:, study evidence tables in Appendix D:, forest plots in Appendix E:and GRADE tables in Appendix F:.

1.4.2. Excluded studies

See the excluded studies list in Appendix I:.

1.4.3. Summary of clinical studies included in the evidence review

No clinical evidence was identified for this review.

1.4.4. Quality assessment of clinical studies included in the evidence review

No clinical evidence was identified for this review.

See Appendix F: for full GRADE tables.

1.5. Economic evidence

1.5.1. Included studies

No health economic studies were included.

1.5.2. Excluded studies

No relevant health economic studies were excluded due to assessment of limited applicability or methodological limitations.

See also the health economic study selection flow chart in Appendix G:.

1.5.3. Summary of studies included in the economic evidence review

No economic studies were included

1.6. Evidence statements

1.6.1. Clinical evidence statements

No clinical evidence was identified.

1.6.2. Health economic evidence statements

No relevant economic evaluations were identified.

1.7. The committee’s discussion of the evidence

1.7.1. Interpreting the evidence

1.7.1.1. The outcomes that matter most

Outcomes considered to be critical as listed in the protocol were all-cause mortality, cardiac mortality, health-related quality of life, stroke or TIA and hospitalisation for heart failure or other cardiac event.

One additional outcome of new-onset atrial fibrillation was included as an important outcome.

It was agreed that in terms of time-points for outcome reporting, where possible, all outcomes should be reported at 6 months (when follow-up is more frequent than once a year) and ≥12 months (for all monitoring frequencies). Where multiple time-points are reported within a single study, the longest time-point only would be extracted.

The outcome of stroke or TIA was included in this review but not in the other monitoring review as stroke and TIA is more of an issue once intervention has been performed on the valve.

1.7.1.2. The quality of the evidence

No clinical evidence was included in the review.

1.7.1.3. Benefits and harms

In the absence of any evidence matching the protocol for this review, the committee discussed current practice with regards to the frequency of echocardiography performed following valve intervention and used this to inform a consensus recommendation.

The committee noted that current practice for those that had received valve repair or replacement was variable and depends on patient factors, such as comorbidities and the shape of the heart due to either other cardiac disease or previous cardiac operations, as well as the type of procedure that has been performed (repair or replacement).

In addition, the type of valve used if replacement was performed is also a factor that means follow-up frequency post-intervention varies. The committee agreed that the durability of mechanical valves is considered to be very good and the risk of needing a redo operation due to valve failure following the operation is low, whereas bioprosthetic valves have a lower durability and deterioration may occur within 10 years. Due to this, the committee noted that in some cases mechanical valves may be monitored initially over the first 12 months and then not followed up regularly unless any problems develop, but that practice was variable for mechanical valve monitoring. However, with bioprosthetic valves monitoring would usually be performed more often – though the committee noted that the frequency of follow-up for those with bioprosthetic valves does vary in practice, with examples including, but not limited to, follow-up annually starting from the year of the operation and others starting annual follow-up of the valves once 5 years has passed.

It was also agreed that any concerns about abnormal valve function or consequences of the procedure, for example paravalvular leak, may also affect the frequency of monitoring, as if there are existing concerns then follow-up may be performed more often than for those where there are no current concerns about the valve function or consequences of the procedure.

The committee also noted the potential effects that the frequency of follow-up can have on patients and that it should be discussed with the patient. For example, follow-up more frequently could increase the anxiety of some patients as they feel they are not able to go about their life without thinking about their condition for a substantial period of time, while for others more frequent follow-up may help to ease any concerns they have about their condition.

The committee agreed that despite the monitoring frequency agreed upon, it is important to encourage patients who feel that their condition has deteriorated to seek further review and arrange for a follow-up sooner. In addition, the committee noted that follow-up for other concomitant cardiac conditions should be performed as appropriate.

Overall, in terms of current practice, the committee agreed that practice was variable and used this to develop a consensus recommendation for the monitoring of those with repaired or replaced heart valves. This recommendation did not specify a frequency at which follow-up should be performed but that the decision should be based on the durability of the prosthetic valve or of the result of the repair, the presence of another condition, including other heart disease, residual valve abnormality or consequences of the procedure (for example, paravalvular leak), concerns about abnormal valve function and the patient’s wishes, as described in detail in the previous paragraphs. The recommendation also states that people and their family or carers should be advised to seek advice if their heart condition deteriorates in between scheduled follow-up appointments. The need for ongoing surveillance should be shared with the patient and relevant health care professionals as part of good clinical practice.

To address the lack of evidence the committee made a research recommendation (see Appendix J.1 for details) on the monitoring after different type of valve interventions including repair and replacement with tissue or mechanical valves.

Evidence from expert testimony to cover the population of pregnant women or women of childbearing age indicated that monitoring of pregnant women may be different in terms of the frequency and type of monitoring required, which is covered by a recommendation discussed in evidence review A about referring to a cardiologist with expertise in the care of pregnant women if they have moderate or severe valve disease, bicuspid aortic valve disease of any severity and associated aortopathy, or a mechanical prosthetic valve.

1.7.2. Cost effectiveness and resource use

No health economic evidence was identified for this question.

The committee made a consensus recommendation to alert clinicians of the common factors that need to be taken into account when deciding on the frequency and type of monitoring for patients with a repaired or replaced heart valve. The committee noted that this recommendation is in line with current practice and does not necessary change the monitoring for this population and therefore unlikely to have a substantial resource impact.

1.8. Recommendations supported by this evidence review

This evidence review supports recommendation 1.8.1 and the research recommendation on monitoring after an intervention.

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Appendices

Appendix B. Literature search strategies

Heart valve disease – search strategy 11 - monitoring of people with heart valve disease and no current indication for intervention AND monitoring in people with repaired or replaced heart valves

This literature search strategy was used for the following reviews:

  • Where there is no current indication for intervention, what is the most clinically and cost-effective type and frequency of test for monitoring in adults with heart valve disease?
  • What is the most clinically and cost-effective frequency of echocardiography or clinical review for monitoring in adults with repaired or replaced heart valves?

The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual.40

For more information, please see the Methodology review published as part of the accompanying documents for this guideline.

B.1. Clinical search literature search strategy (PDF, 371K)

B.2. Health Economics literature search strategy (PDF, 269K)

Appendix D. Clinical evidence tables

No clinical evidence was identified for this review.

Appendix E. Forest plots

No clinical evidence was identified for this review.

Appendix F. GRADE tables

No clinical evidence was identified for this review.

Appendix G. Health economic evidence selection

Download PDF (245K)

Appendix H. Health economic evidence tables

No economic studies have been identified

Appendix I. Excluded studies

I.1. Excluded clinical studies (PDF, 154K)

I.2. Excluded health economic studies (PDF, 131K)

Appendix J. Research recommendations

J.1. Monitoring after intervention (PDF, 190K)

Final draft

Intervention evidence review underpinning recommendation 1.8.1 and the research recommendation in the NICE guideline

Developed by the National Guideline Centre, hosted by the Royal College of Physicians

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and, where appropriate, their carer or guardian.

Local commissioners and providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.

Copyright © NICE 2021.
Bookshelf ID: NBK577830PMID: 35143142

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