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monitoring in people with repaired or replaced heart valves" /></a></div><div class="bkr_bib"><h1 id="_NBK577830_"><span itemprop="name">Evidence review for monitoring in people with repaired or replaced heart valves</span></h1><div class="subtitle">Heart valve disease presenting in adults: investigation and management</div><p><b>Evidence review K</b></p><p><i>NICE Guideline, No. 208</i></p><p class="contrib-group"><h4>Authors</h4><span itemprop="author">National Guideline Centre (UK)</span>.</p><div class="half_rhythm">London: <a href="https://www.nice.org.uk" ref="pagearea=meta&amp;targetsite=external&amp;targetcat=link&amp;targettype=publisher"><span itemprop="publisher">National Institute for Health and Care Excellence (NICE)</span></a>; <span itemprop="datePublished">2021 Nov</span>.<div class="small">ISBN-13: <span itemprop="isbn">978-1-4731-4301-2</span></div></div><div><a href="/books/about/copyright/">Copyright</a> &#x000a9; NICE 2021.</div></div><div class="bkr_clear"></div></div><div id="niceng208er11.s1"><h2 id="_niceng208er11_s1_">1. Monitoring</h2><div id="niceng208er11.s1.1"><h3>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?</h3></div><div id="niceng208er11.s1.2"><h3>1.2. Introduction</h3><p>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.</p></div><div id="niceng208er11.s1.3"><h3>1.3. PICO table</h3><p>For full details see the review protocol in <a href="#niceng208er11.appa">Appendix A</a>:.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng208er11tab1"><a href="/books/NBK577830/table/niceng208er11.tab1/?report=objectonly" target="object" title="Table 1" class="img_link icnblk_img figpopup" rid-figpopup="figniceng208er11tab1" rid-ob="figobniceng208er11tab1"><img class="small-thumb" src="/books/NBK577830/table/niceng208er11.tab1/?report=thumb" src-large="/books/NBK577830/table/niceng208er11.tab1/?report=previmg" alt="Table 1. PICO characteristics of review question." /></a><div class="icnblk_cntnt"><h4 id="niceng208er11.tab1"><a href="/books/NBK577830/table/niceng208er11.tab1/?report=objectonly" target="object" rid-ob="figobniceng208er11tab1">Table 1</a></h4><p class="float-caption no_bottom_margin">PICO characteristics of review question. </p></div></div></div><div id="niceng208er11.s1.4"><h3>1.4. Clinical evidence</h3><div id="niceng208er11.s1.4.1"><h4>1.4.1. Included studies</h4><p>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.</p><p>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,<a class="bibr" href="#niceng208er11.ref1" rid="niceng208er11.ref1"><sup>1</sup></a> 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.</p><p>See also the study selection flow chart in <a href="#niceng208er11.appc">Appendix C</a>:, study evidence tables in <a href="#niceng208er11.appd">Appendix D</a>:, forest plots in <a href="#niceng208er11.appe">Appendix E</a>:and GRADE tables in <a href="#niceng208er11.appf">Appendix F</a>:.</p></div><div id="niceng208er11.s1.4.2"><h4>1.4.2. Excluded studies</h4><p>See the excluded studies list in <a href="#niceng208er11.appi">Appendix I</a>:.</p></div><div id="niceng208er11.s1.4.3"><h4>1.4.3. Summary of clinical studies included in the evidence review</h4><p>No clinical evidence was identified for this review.</p></div><div id="niceng208er11.s1.4.4"><h4>1.4.4. Quality assessment of clinical studies included in the evidence review</h4><p>No clinical evidence was identified for this review.</p><p>See <a href="#niceng208er11.appf">Appendix F</a>: for full GRADE tables.</p></div></div><div id="niceng208er11.s1.5"><h3>1.5. Economic evidence</h3><div id="niceng208er11.s1.5.1"><h4>1.5.1. Included studies</h4><p>No health economic studies were included.</p></div><div id="niceng208er11.s1.5.2"><h4>1.5.2. Excluded studies</h4><p>No relevant health economic studies were excluded due to assessment of limited applicability or methodological limitations.</p><p>See also the health economic study selection flow chart in <a href="#niceng208er11.appg">Appendix G</a>:.</p></div><div id="niceng208er11.s1.5.3"><h4>1.5.3. Summary of studies included in the economic evidence review</h4><p>No economic studies were included</p></div></div><div id="niceng208er11.s1.6"><h3>1.6. Evidence statements</h3><div id="niceng208er11.s1.6.1"><h4>1.6.1. Clinical evidence statements</h4><p>No clinical evidence was identified.</p></div><div id="niceng208er11.s1.6.2"><h4>1.6.2. Health economic evidence statements</h4><p>No relevant economic evaluations were identified.</p></div></div><div id="niceng208er11.s1.7"><h3>1.7. The committee&#x02019;s discussion of the evidence</h3><div id="niceng208er11.s1.7.1"><h4>1.7.1. Interpreting the evidence</h4><div id="niceng208er11.s1.7.1.1"><h5>1.7.1.1. The outcomes that matter most</h5><p>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.</p><p>One additional outcome of new-onset atrial fibrillation was included as an important outcome.</p><p>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 &#x02265;12 months (for all monitoring frequencies). Where multiple time-points are reported within a single study, the longest time-point only would be extracted.</p><p>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.</p></div><div id="niceng208er11.s1.7.1.2"><h5>1.7.1.2. The quality of the evidence</h5><p>No clinical evidence was included in the review.</p></div><div id="niceng208er11.s1.7.1.3"><h5>1.7.1.3. Benefits and harms</h5><p>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.</p><p>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).</p><p>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 &#x02013; 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.</p><p>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.</p><p>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.</p><p>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.</p><p>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&#x02019;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.</p><p>To address the lack of evidence the committee made a research recommendation (see <a href="#niceng208er11.appj.et1">Appendix J.1</a> for details) on the monitoring after different type of valve interventions including repair and replacement with tissue or mechanical valves.</p><p>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.</p></div></div><div id="niceng208er11.s1.7.2"><h4>1.7.2. Cost effectiveness and resource use</h4><p>No health economic evidence was identified for this question.</p><p>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.</p></div></div><div id="niceng208er11.s1.8"><h3>1.8. Recommendations supported by this evidence review</h3><p>This evidence review supports recommendation 1.8.1 and the research recommendation on monitoring after an intervention.</p></div></div><div id="niceng208er11.rl.r1"><h2 id="_niceng208er11_rl_r1_">References</h2><dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>1.</dt><dd><div class="bk_ref" id="niceng208er11.ref1">Alaour
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et al. Role of multislice computed tomography in transcatheter aortic valve replacement. American Journal of Cardiology. 2009; 103(9):1295&#x02013;1301 [<a href="https://pubmed.ncbi.nlm.nih.gov/19406275" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 19406275</span></a>]</div></dd></dl></dl></div><div id="appendixesappgroup1"><h2 id="_appendixesappgroup1_">Appendices</h2><div id="niceng208er11.appa"><h3>Appendix A. Review protocols</h3><p id="niceng208er11.appa.et1"><a href="/books/NBK577830/bin/niceng208er11-appa-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 2. Review protocol: Monitoring in people with repaired or replaced heart valves</a><span class="small"> (PDF, 219K)</span></p><p id="niceng208er11.appa.et2"><a href="/books/NBK577830/bin/niceng208er11-appa-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 3. Health economic review protocol</a><span class="small"> (PDF, 179K)</span></p></div><div id="niceng208er11.appb"><h3>Appendix B. Literature search strategies</h3><p>
<u>Heart valve disease &#x02013; 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</u>
</p><p>This literature search strategy was used for the following reviews:
<ul><li class="half_rhythm"><div>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?</div></li><li class="half_rhythm"><div>What is the most clinically and cost-effective frequency of echocardiography or clinical review for monitoring in adults with repaired or replaced heart valves?</div></li></ul></p><p>The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual.<a class="bibr" href="#niceng208er11.ref40" rid="niceng208er11.ref40"><sup>40</sup></a></p><p>For more information, please see the Methodology review published as part of the accompanying documents for this guideline.</p><p id="niceng208er11.appb.et1"><a href="/books/NBK577830/bin/niceng208er11-appb-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">B.1. Clinical search literature search strategy</a><span class="small"> (PDF, 371K)</span></p><p id="niceng208er11.appb.et2"><a href="/books/NBK577830/bin/niceng208er11-appb-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">B.2. Health Economics literature search strategy</a><span class="small"> (PDF, 269K)</span></p></div><div id="niceng208er11.appc"><h3>Appendix C. Clinical evidence selection</h3><p id="niceng208er11.appc.et1"><a href="/books/NBK577830/bin/niceng208er11-appc-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 1. Flow chart of clinical study selection for the review of monitoring in people with repaired or replaced heart valves</a><span class="small"> (PDF, 143K)</span></p></div><div id="niceng208er11.appd"><h3>Appendix D. Clinical evidence tables</h3><p>No clinical evidence was identified for this review.</p></div><div id="niceng208er11.appe"><h3>Appendix E. Forest plots</h3><p>No clinical evidence was identified for this review.</p></div><div id="niceng208er11.appf"><h3>Appendix F. GRADE tables</h3><p>No clinical evidence was identified for this review.</p></div><div id="niceng208er11.appg"><h3>Appendix G. Health economic evidence selection</h3><p id="niceng208er11.appg.et1"><a href="/books/NBK577830/bin/niceng208er11-appg-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (245K)</span></p></div><div id="niceng208er11.apph"><h3>Appendix H. Health economic evidence tables</h3><p>No economic studies have been identified</p></div><div id="niceng208er11.appi"><h3>Appendix I. Excluded studies</h3><p id="niceng208er11.appi.et1"><a href="/books/NBK577830/bin/niceng208er11-appi-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">I.1. Excluded clinical studies</a><span class="small"> (PDF, 154K)</span></p><p id="niceng208er11.appi.et2"><a href="/books/NBK577830/bin/niceng208er11-appi-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">I.2. Excluded health economic studies</a><span class="small"> (PDF, 131K)</span></p></div><div id="niceng208er11.appj"><h3>Appendix J. Research recommendations</h3><p id="niceng208er11.appj.et1"><a href="/books/NBK577830/bin/niceng208er11-appj-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">J.1. Monitoring after intervention</a><span class="small"> (PDF, 190K)</span></p></div></div></div><div class="fm-sec"><div><p>Final draft</p></div><div><p>Intervention evidence review underpinning recommendation 1.8.1 and the research recommendation in the NICE guideline</p><p>Developed by the National Guideline Centre, hosted by the Royal College of Physicians</p></div><div><p><b>Disclaimer</b>: 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.</p><p>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.</p><p>NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the <a href="http://wales.gov.uk/" ref="pagearea=body&amp;targetsite=external&amp;targetcat=link&amp;targettype=uri">Welsh Government</a>, <a href="http://www.scotland.gov.uk/" ref="pagearea=body&amp;targetsite=external&amp;targetcat=link&amp;targettype=uri">Scottish Government</a>, and <a href="http://www.northernireland.gov.uk/" ref="pagearea=body&amp;targetsite=external&amp;targetcat=link&amp;targettype=uri">Northern Ireland Executive</a>. All NICE guidance is subject to regular review and may be updated or withdrawn.</p></div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright</a> &#x000a9; NICE 2021.</div><div class="small"><span class="label">Bookshelf ID: NBK577830</span><span class="label">PMID: <a href="https://pubmed.ncbi.nlm.nih.gov/35143142" title="PubMed record of this title" ref="pagearea=meta&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">35143142</a></span></div></div><div class="small-screen-prev"></div><div class="small-screen-next"></div></article><article data-type="table-wrap" id="figobniceng208er11tab1"><div id="niceng208er11.tab1" class="table"><h3><span class="label">Table 1</span><span class="title">PICO characteristics of review question</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577830/table/niceng208er11.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng208er11.tab1_lrgtbl__"><table><tbody><tr><th id="hd_b_niceng208er11.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><td headers="hd_b_niceng208er11.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"><p>Inclusion:</p>
<p>Adults 18 years and over with heart valve disease and repaired or replaced heart valves, stratified by biological (including transcatheter) or mechanical valves and repair or replacement:
<ul><li class="half_rhythm"><div>Repair</div></li><li class="half_rhythm"><div>Replacement with biological valves</div></li><li class="half_rhythm"><div>Replacement with homograft and autograft valves (including the Ross procedure)</div></li><li class="half_rhythm"><div>Replacement with mechanical valves</div></li><li class="half_rhythm"><div>Replacement with mixture of biological and mechanical valves (i.e. some in population with biological and some with mechanical)</div></li></ul></p>
<p>A threshold of 75% will be used to assign studies to the above strata.</p>
<p>Exclusion:</p>
<p>Children aged less than 18 years.</p>
<p>Adults with congenital heart disease (excluding bicuspid aortic valves).</p>
<p>Tricuspid stenosis and pulmonary valve disease.</p></td></tr><tr><th id="hd_b_niceng208er11.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Interventions/tests</th><td headers="hd_b_niceng208er11.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Monitoring by echocardiography (transthoracic or transoesophageal) at various frequencies followed by appropriate valve re-do intervention:
<ul><li class="half_rhythm"><div>More frequently than once a year (&#x0003c;12 months e.g. every 3 or 6 months)</div></li><li class="half_rhythm"><div>Once a year (every 12 months)</div></li><li class="half_rhythm"><div>Less frequently than once a year (&#x0003e;12 months; e.g. every 2, 3 or 5 years)</div></li></ul></td></tr><tr><th id="hd_b_niceng208er11.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparisons</th><td headers="hd_b_niceng208er11.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"><p>Other active comparator listed above</p>
<p>No monitoring/clinical review (echo only performed if new symptoms emerge/symptoms worsen)</p></td></tr><tr><th id="hd_b_niceng208er11.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</th><td headers="hd_b_niceng208er11.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Primary outcomes:
<ul><li class="half_rhythm"><div>All-cause mortality</div></li><li class="half_rhythm"><div>Cardiac mortality</div></li><li class="half_rhythm"><div>Health-related quality of life</div></li><li class="half_rhythm"><div>Stroke or TIA</div></li><li class="half_rhythm"><div>Hospitalisation for heart failure or other cardiac event</div></li></ul>
Secondary outcomes:
<ul><li class="half_rhythm"><div>New onset atrial fibrillation</div></li></ul>
All outcomes to be measured at 6 months (when follow-up is more frequent than once a year) and &#x02265;12 months (for all monitoring frequencies). Where multiple time-points are reported within a single study, the longest time-point only will be extracted.</td></tr><tr><th id="hd_b_niceng208er11.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study design</th><td headers="hd_b_niceng208er11.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"><p>Randomised controlled trials (RCTs) and systematic reviews of RCTs. Published NMAs and IPDs will be considered for inclusion</p>
<p>If insufficient evidence is found from RCT, non-randomised studies (NRS) will be considered for inclusion.</p>
<p>Important confounders that NRS should be adjusted for:
<ul><li class="half_rhythm"><div>Dialysis (haemodialysis or peritoneal dialysis)</div></li><li class="half_rhythm"><div>Poor INR control</div></li><li class="half_rhythm"><div>Endocarditis (provoking valve destruction earlier)</div></li></ul></p></td></tr></tbody></table></div></div></article></div><div id="jr-scripts"><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/libs.min.js"> </script><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.min.js"> </script></div></div>
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