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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

.

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

1. Monitoring

1.1. Review question: 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?

1.2. Introduction

Heart valve disease progresses gradually at a slow pace, with only rare unpredictable worsening, abruptly or at a faster pace. Clinical and haemodynamic consequences of heart valve disease usually develop at later stages of the disease. To avoid unnecessary tests but also the late detection of indications for intervention, it is important to determine the most clinically and cost-effective type and frequency of test for monitoring of heart valve disease.

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

One study was included in the review;1 this is summarised in Table 2 below. Evidence from this study is summarised in the clinical evidence summary below (Table 3).

A search was conducted for randomised trials comparing the effectiveness of various different types and frequencies of monitoring compared to each other or no routine monitoring in patients with heart valve disease and no current indication for intervention. No randomised trials matching the protocol were identified, so observational studies were considered for inclusion as pre-specified in the protocol.

One retrospective cohort study was subsequently included in the review; this study compared a guideline adherent group with a guideline non-adherent group by retrospective review of medical records in those with severe asymptomatic aortic stenosis. However, this study was considered to be indirect compared with the protocol as the frequency of monitoring varied in the guideline adherent group [defined as clinical review with echocardiography and cardiopulmonary physical examination every 12 (±6) months] and there was no description of the monitoring that occurred in the guideline non-adherent group, meaning it could have included those undergoing follow-up more often, less often or using different methods than recommended in the guidelines. However, this study was included due to a lack of other available evidence from comparative studies and downgraded for indirectness.

The protocol specified that any non-randomised studies included should have adjusted outcomes for two key confounders for aortic stenosis: coronary artery disease and aortopathy. The proportion in each group with coronary artery disease was reported to be similar in both groups, but aortopathy was not mentioned and it is unclear whether this may have differed between the groups. For the mortality outcome, a value adjusted for coronary artery disease was provided but only an unadjusted result was available for the heart failure hospitalisation outcome.

Further limitations identified were the fact that the number of patients that received surgical or catheter-based aortic valve replacement during follow-up was higher in the guideline adherent group compared with the guideline non-adherent group, which was taken into account in the risk of bias rating, and the fact that the ideal time-point of 6 months follow-up, as specified in the protocol, could not be obtained for the all-cause mortality outcome and a 1-year time-point was instead obtained.

Further detail about these limitations are discussed in more detail in section 1.7.1.2 below.

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

Table 2. Summary of studies included in the evidence review.

Table 2

Summary of studies included in the evidence review.

See Appendix D: for full evidence tables.

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

1.4.4.1. Mild heart valve disease

No evidence was identified for this stratum.

1.4.4.2. Moderate heart valve disease

No evidence was identified for this stratum.

1.4.4.3. Severe heart valve disease
Table 3. Clinical evidence summary: Guideline adherent [clinical review + echocardiography every 12 (±6) months] vs. guideline non-adherent group.

Table 3

Clinical evidence summary: Guideline adherent [clinical review + echocardiography every 12 (±6) months] vs. guideline non-adherent group.

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 found

1.5.4. Health economic modelling

This area was not prioritised for new cost-effectiveness analysis.

1.5.5. Unit costs

Relevant unit costs are provided below to aid consideration of cost effectiveness.

Table 4. UK costs of monitoring tests for heart valve disease.

Table 4

UK costs of monitoring tests for heart valve disease.

1.6. Evidence statements

1.6.1. Clinical evidence statements

See the summary of evidence in Table 3.

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 (any validated measure) and hospitalisation for heart failure or any other cardiac reason.

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

It was agreed that the preferred time-points for reporting outcomes would depend on the severity of the valve disease, with 12 months preferable for mild or moderate valve disease and 6-month data preferable for severe valve disease. This reflects how often the respective severities are usually followed up in current practice.

Evidence included in this review was very limited, with only two outcomes from a single study being identified. Outcomes with no evidence were as follows: cardiac mortality, health-related quality of life and new-onset atrial fibrillation.

1.7.1.2. The quality of the evidence

A single, retrospective study, which consisted of a review of medical records, was included in this review and covered the severe valve disease group, consisting of people with severe asymptomatic aortic stenosis. Two outcomes were extracted from the study and both were rated as very low quality evidence, being downgraded for risk of bias, indirectness and imprecision. Indirectness was due to the limitations highlighted below in terms of the definition of monitoring in the non-adherent group.

No relevant studies were identified for the following populations: mild valve disease and moderate valve disease.

This study compared outcomes between a group that adhered to existing guidelines and a group that did not. This study was limited as there was no definition of the level of the monitoring that the non-adherent group actually received and it was unclear whether they were followed up less often, more often or were followed up at the same frequency as the adherent group but the methods used for monitoring did not meet the criteria specified in the guidelines. In addition, in the adherent group the frequency of monitoring varied between participants with 12±6 months being reported for the group.

Further limitations associated with this study concern adjustment for confounders. The protocol specified that any non-randomised studies included should have adjusted outcomes for two key confounders for aortic stenosis: coronary artery disease and aortopathy. Although the proportion in each group with coronary artery disease was reported to be similar in both groups, aortopathy was not mentioned and it is unclear whether this may have differed between the groups. For the all-cause mortality outcome, an adjusted value including coronary artery disease as a covariate was provided. For the heart failure hospitalisation outcome, an adjusted value was not provided, but this outcome was still included in the review as the proportion with coronary artery disease at baseline was similar between the groups and there was no other evidence available. As mentioned, both of these outcomes were not adjusted for aortopathy and it is unclear whether this factor may have differed between the groups. Due to a lack of other available evidence these outcomes were included in the review despite this, but this contributed to the decision to downgrade the outcomes for indirectness.

Additionally, though an absolute effect for the 6 month time-point (as pre-specified for severe valve disease in the protocol) was obtained from the study for the heart failure hospitalisation outcome using the reported hazard ratio and control group risk at 6 months from the survival curve, the same could not be done for the mortality outcome due to there being zero events for this outcome in the control group at 6 months. Therefore, for the all-cause mortality outcome a time-point of 1 year was used. The study reported the control group risk at the 4 year time-point for mortality and this could also be obtained from the survival curve for the heart failure hospitalisation outcome; however, these were not used as this was a much longer follow-up than the 6 month time-point specified in the protocol for severe valve disease.

One factor that was substantially different between the groups during the follow-up was the number of patients in each group that received surgical or catheter-based aortic valve replacement – this was higher in the guideline adherent group compared with the guideline non-adherent group (54 vs. 19.4%) and may have contributed to differences in outcomes. The committee agreed that this may have been the case, as with an enhanced monitoring strategy those requiring intervention could be picked up sooner and intervention performed to improve patient outcomes and prevent deterioration. This was taken into account in the risk of bias assessment for both outcomes and contributed to the overall grading of high or very high risk of bias.

The quality of the evidence identified and the other limitations described in the benefits and harms section below meant that although the included study was taken into account when making the recommendation, the recommendation made was largely based on the clinical experience of the committee and was considered to be in line with current practice. This meant that an offer recommendation was agreed to be appropriate. Although the only evidence identified was in the asymptomatic severe aortic stenosis population, the committee agreed it was appropriate to extrapolate the recommendation to cover any type of asymptomatic severe valve disease.

1.7.1.3. Benefits and harms

The study included in this review compared the outcomes of a guideline adherent group with a guideline non-adherent group in people with asymptomatic severe aortic stenosis by retrospective review of medical records. Of the two outcomes that were reported (all-cause mortality and heart failure hospitalisation), both demonstrated fewer events in the guideline adherent group compared with the guideline non-adherent group based on absolute differences calculated at 6 (heart failure hospitalisation) or 12 months (all-cause mortality), with a clinically important benefit identified for all-cause mortality. Although there was uncertainty in terms of the size of the effect based on the confidence intervals, confidence intervals were quite narrow and were also consistent with reduced events in the guideline adherent group compared with the non-adherent group. No data were available for the following outcomes for the severe asymptomatic aortic stenosis population: cardiac mortality, health-related quality of life and new-onset atrial fibrillation.

The committee agreed that the evidence available was very limited to be able to inform recommendations. They noted the limitations associated with the single study identified, including the lack of definition of the guideline non-adherent group and the fact that monitoring frequency varied between patients in the guideline adherent group. In addition, the committee also highlighted that this study was performed in the USA, where medical insurance is required to cover costs of medical care. They agreed that the requirement for medical insurance means each follow-up appointment represents a further cost to those that are not insured and may affect the premiums of those that claim for these tests on insurance policies, which may deter people from going if they feel well. The committee highlighted that this makes the study less applicable to the system in the UK.

The committee agreed that despite the limitations, the results of the study made sense, as enhanced monitoring may allow those requiring intervention to be picked up sooner and have intervention to prevent negative outcomes, such as mortality and hospitalisation for heart failure, occurring. However, they noted that there could be an association between being sicker, including having more severe disease or in terms of general health, and being in the guideline non-adherent group, due to the study being non-randomised and not adjusting for such confounders.

In terms of current practice, this was considered to be variable for the asymptomatic severe aortic stenosis population. Currently, frequency of follow-up was considered to be between 6 and 12 months for this group, with this depending on how well the patient was considered to be and also patient preferences. The committee agreed that those that were thought to be particularly unwell may be followed-up more often, every 6 months, whereas most would be followed up every 12 months. The committee explained that the rationale for the current frequency of follow-up in this population was that the rate of progression of the consequences of severe aortic stenosis or the rate at which symptoms develop usually involves a decline over a period of months rather than years, and longer periods between follow-ups would mean negative outcomes occur before the next follow-up in many cases.

Therefore, although the included study did inform the recommendation to a certain extent, it was mostly based on current practice for this population and the committee’s experience due to the limitations with the included study. The committee noted that echocardiography had been a required component in the guideline adherent group of the included study and in order to assess possible need for intervention at each follow-up should be performed.

In addition, the committee highlighted that the proposed monitoring strategy for the asymptomatic severe heart valve disease population is relevant to those in whom an intervention may be considered in the future. In those that are too frail for intervention to be considered at all in the future, the committee noted that follow-up may differ for this group.

The committee therefore made a consensus recommendation that people with severe asymptomatic heart valve disease, who may be suitable for future intervention, be followed up every 6–12 months by clinical review and echocardiography. The committee agreed that the exact frequency of monitoring within the 6- to 12-month timeframe should be determined by echocardiography results and shared decision making with the patient. Although the only evidence identified was in the asymptomatic severe aortic stenosis population, the committee agreed it was appropriate to extrapolate the recommendation to cover any type of asymptomatic severe valve disease.

No evidence was identified for any mild or moderate valve disease. Consensus recommendations could not be made for mild or moderate valve disease as there was considered to be more variation in practice for these populations and the recommendation for asymptomatic severe heart valve disease could not be extrapolated to cover these populations as the difference in severity means they are different in terms of the extent of follow-up required. It was therefore agreed that research recommendations would be made to cover these areas, which included asymptomatic mild or moderate valve disease (see Appendix J.1 for details) and symptomatic moderate valve disease (see Appendix J.2.1 for details) , as well as further research recommendations for severe asymptomatic valve disease due to the limitations discussed with the single included study for this population (see Appendix J.3.1 for details).

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 strong consensus recommendation for an enhanced monitoring strategy for the asymptomatic severe heart valve disease group who may be suitable for future intervention. Although the cost effectiveness is uncertain, monitoring of this group is crucial to treatment because it enables identification of those patients for whom surgery is most timely, leading to improved survival and quality of life.

The committee noted that this recommendation was in line with current practice where follow-up was considered every 12 months, where the patient’s health is considered stable, or 6 months, where there is concern about the patient’s health deteriorating. This means there should not be a resource impact.

1.8. Recommendations supported by this evidence review

This evidence review supports recommendation 1.4.1 and 3 research recommendations on monitoring where there is no current need for 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.49

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, 438K)

B.2. Health Economics literature search strategy (PDF, 294K)

Appendix D. Clinical evidence tables

Download PDF (152K)

Appendix E. Forest plots

E.1. Mild heart valve disease

No evidence was identified for this stratum.

E.2. Moderate heart valve disease

No evidence was identified for this stratum.

E.3. Severe heart valve disease

Download PDF (172K)

Appendix F. GRADE tables

F.1. Mild heart valve disease

No evidence was identified for this stratum.

F.2. Moderate heart valve disease

No evidence was identified for this stratum.

F.3. Severe heart valve disease

Download PDF (168K)

Appendix G. Health economic evidence selection

Download PDF (252K)

Appendix H. Health economic evidence tables

None

Appendix I. Excluded studies

I.1. Excluded clinical studies

Download PDF (183K)

I.2. Excluded health economic studies

Published health economic studies that met the inclusion criteria (relevant population, comparators, economic study design, published 2004 or later and not from non-OECD country or USA) but that were excluded following appraisal of applicability and methodological quality are listed below. See the health economic protocol for more details.

None.

Final

Intervention evidence review underpinning recommendation 1.4.1 and research recommendations 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: NBK577827PMID: 35143141

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