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preserveAspectRatio="none"><path fill="none" stroke="#000" stroke-width="36" stroke-linecap="round" style="fill:#FFF" d="m320,350a153,153 0 1,0-2,2l170,170m-91-117 110,110-26,26-110-110"></path></svg></a><a id="jr-fip-done" class="wsprkl btn" title="Dismiss find">✘</a></nav><nav id="jr-fip-info-p"><a id="jr-fip-prev" class="wsprkl btn" title="Jump to previuos match">◀</a><button id="jr-fip-matches">no matches yet</button><a id="jr-fip-next" class="wsprkl btn" title="Jump to next match">▶</a></nav></nav></div><div id="jr-epub-interstitial" class="hidden"></div><div id="jr-content"><article data-type="main"><div class="main-content lit-style"><div class="fm-sec bkr_bottom_sep"><div class="bkr_thumb"><a href="https://www.nice.org.uk" title="National Institute for Health and Care Excellence (NICE)" class="img_link icnblk_img" ref="pagearea=logo&targetsite=external&targetcat=link&targettype=publisher"><img class="source-thumb" src="/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-niceng208er7-lrg.png" alt="Cover of Evidence review for monitoring of people with heart valve disease and no current indication for intervention" /></a></div><div class="bkr_bib"><h1 id="_NBK577827_"><span itemprop="name">Evidence review for monitoring of people with heart valve disease and no current indication for intervention</span></h1><div class="subtitle">Heart valve disease presenting in adults: investigation and management</div><p><b>Evidence review G</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&targetsite=external&targetcat=link&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> © NICE 2021.</div></div><div class="bkr_clear"></div></div><div id="niceng208er7.s1"><h2 id="_niceng208er7_s1_">1. Monitoring</h2><div id="niceng208er7.s1.1"><h3>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?</h3></div><div id="niceng208er7.s1.2"><h3>1.2. Introduction</h3><p>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.</p></div><div id="niceng208er7.s1.3"><h3>1.3. PICO table</h3><p>For full details see the review protocol in <a href="#niceng208er7.appa">Appendix A</a>:.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng208er7tab1"><a href="/books/NBK577827/table/niceng208er7.tab1/?report=objectonly" target="object" title="Table 1" class="img_link icnblk_img figpopup" rid-figpopup="figniceng208er7tab1" rid-ob="figobniceng208er7tab1"><img class="small-thumb" src="/books/NBK577827/table/niceng208er7.tab1/?report=thumb" src-large="/books/NBK577827/table/niceng208er7.tab1/?report=previmg" alt="Table 1. PICO characteristics of review question." /></a><div class="icnblk_cntnt"><h4 id="niceng208er7.tab1"><a href="/books/NBK577827/table/niceng208er7.tab1/?report=objectonly" target="object" rid-ob="figobniceng208er7tab1">Table 1</a></h4><p class="float-caption no_bottom_margin">PICO characteristics of review question. </p></div></div></div><div id="niceng208er7.s1.4"><h3>1.4. Clinical evidence</h3><div id="niceng208er7.s1.4.1"><h4>1.4.1. Included studies</h4><p>One study was included in the review;<a class="bibr" href="#niceng208er7.ref1" rid="niceng208er7.ref1"><sup>1</sup></a> this is summarised in <a class="figpopup" href="/books/NBK577827/table/niceng208er7.tab2/?report=objectonly" target="object" rid-figpopup="figniceng208er7tab2" rid-ob="figobniceng208er7tab2">Table 2</a> below. Evidence from this study is summarised in the clinical evidence summary below (<a class="figpopup" href="/books/NBK577827/table/niceng208er7.tab3/?report=objectonly" target="object" rid-figpopup="figniceng208er7tab3" rid-ob="figobniceng208er7tab3">Table 3</a>).</p><p>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.</p><p>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.</p><p>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.</p><p>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.</p><p>Further detail about these limitations are discussed in more detail in <a href="#niceng208er7.s1.7.1.2">section 1.7.1.2</a> below.</p><p>See also the study selection flow chart in <a href="#niceng208er7.appc">Appendix C</a>:, study evidence tables in <a href="#niceng208er7.appd">Appendix D</a>:, forest plots in <a href="#niceng208er7.appe">Appendix E</a>:and GRADE tables in <a href="#niceng208er7.appf">Appendix F</a>.</p></div><div id="niceng208er7.s1.4.2"><h4>1.4.2. Excluded studies</h4><p>See the excluded studies list in <a href="#niceng208er7.appi">Appendix I</a>:.</p></div><div id="niceng208er7.s1.4.3"><h4>1.4.3. Summary of clinical studies included in the evidence review</h4><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng208er7tab2"><a href="/books/NBK577827/table/niceng208er7.tab2/?report=objectonly" target="object" title="Table 2" class="img_link icnblk_img figpopup" rid-figpopup="figniceng208er7tab2" rid-ob="figobniceng208er7tab2"><img class="small-thumb" src="/books/NBK577827/table/niceng208er7.tab2/?report=thumb" src-large="/books/NBK577827/table/niceng208er7.tab2/?report=previmg" alt="Table 2. Summary of studies included in the evidence review." /></a><div class="icnblk_cntnt"><h4 id="niceng208er7.tab2"><a href="/books/NBK577827/table/niceng208er7.tab2/?report=objectonly" target="object" rid-ob="figobniceng208er7tab2">Table 2</a></h4><p class="float-caption no_bottom_margin">Summary of studies included in the evidence review. </p></div></div><p>See <a href="#niceng208er7.appd">Appendix D</a>: for full evidence tables.</p></div><div id="niceng208er7.s1.4.4"><h4>1.4.4. Quality assessment of clinical studies included in the evidence review</h4><div id="niceng208er7.s1.4.4.1"><h5>1.4.4.1. Mild heart valve disease</h5><p>No evidence was identified for this stratum.</p></div><div id="niceng208er7.s1.4.4.2"><h5>1.4.4.2. Moderate heart valve disease</h5><p>No evidence was identified for this stratum.</p></div><div id="niceng208er7.s1.4.4.3"><h5>1.4.4.3. Severe heart valve disease</h5><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng208er7tab3"><a href="/books/NBK577827/table/niceng208er7.tab3/?report=objectonly" target="object" title="Table 3" class="img_link icnblk_img figpopup" rid-figpopup="figniceng208er7tab3" rid-ob="figobniceng208er7tab3"><img class="small-thumb" src="/books/NBK577827/table/niceng208er7.tab3/?report=thumb" src-large="/books/NBK577827/table/niceng208er7.tab3/?report=previmg" alt="Table 3. Clinical evidence summary: Guideline adherent [clinical review + echocardiography every 12 (±6) months] vs. guideline non-adherent group." /></a><div class="icnblk_cntnt"><h4 id="niceng208er7.tab3"><a href="/books/NBK577827/table/niceng208er7.tab3/?report=objectonly" target="object" rid-ob="figobniceng208er7tab3">Table 3</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Guideline adherent [clinical review + echocardiography every 12 (±6) months] vs. guideline non-adherent group. </p></div></div><p>See <a href="#niceng208er7.appf">Appendix F</a> for full GRADE tables.</p></div></div></div><div id="niceng208er7.s1.5"><h3>1.5. Economic evidence</h3><div id="niceng208er7.s1.5.1"><h4>1.5.1. Included studies</h4><p>No health economic studies were included.</p></div><div id="niceng208er7.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="#niceng208er7.appg">Appendix G</a>:.</p></div><div id="niceng208er7.s1.5.3"><h4>1.5.3. Summary of studies included in the economic evidence review</h4><p>No economic studies were found</p></div><div id="niceng208er7.s1.5.4"><h4>1.5.4. Health economic modelling</h4><p>This area was not prioritised for new cost-effectiveness analysis.</p></div><div id="niceng208er7.s1.5.5"><h4>1.5.5. Unit costs</h4><p>Relevant unit costs are provided below to aid consideration of cost effectiveness.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng208er7tab4"><a href="/books/NBK577827/table/niceng208er7.tab4/?report=objectonly" target="object" title="Table 4" class="img_link icnblk_img figpopup" rid-figpopup="figniceng208er7tab4" rid-ob="figobniceng208er7tab4"><img class="small-thumb" src="/books/NBK577827/table/niceng208er7.tab4/?report=thumb" src-large="/books/NBK577827/table/niceng208er7.tab4/?report=previmg" alt="Table 4. UK costs of monitoring tests for heart valve disease." /></a><div class="icnblk_cntnt"><h4 id="niceng208er7.tab4"><a href="/books/NBK577827/table/niceng208er7.tab4/?report=objectonly" target="object" rid-ob="figobniceng208er7tab4">Table 4</a></h4><p class="float-caption no_bottom_margin">UK costs of monitoring tests for heart valve disease. </p></div></div></div></div><div id="niceng208er7.s1.6"><h3>1.6. Evidence statements</h3><div id="niceng208er7.s1.6.1"><h4>1.6.1. Clinical evidence statements</h4><p>See the summary of evidence in <a class="figpopup" href="/books/NBK577827/table/niceng208er7.tab3/?report=objectonly" target="object" rid-figpopup="figniceng208er7tab3" rid-ob="figobniceng208er7tab3">Table 3</a>.</p></div><div id="niceng208er7.s1.6.2"><h4>1.6.2. Health economic evidence statements</h4><p>No relevant economic evaluations were identified.</p></div></div><div id="niceng208er7.s1.7"><h3>1.7. The committee’s discussion of the evidence</h3><div id="niceng208er7.s1.7.1"><h4>1.7.1. Interpreting the evidence</h4><div id="niceng208er7.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 (any validated measure) and hospitalisation for heart failure or any other cardiac reason.</p><p>One additional outcome of new-onset atrial fibrillation was included as an important outcome.</p><p>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.</p><p>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.</p></div><div id="niceng208er7.s1.7.1.2"><h5>1.7.1.2. The quality of the evidence</h5><p>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.</p><p>No relevant studies were identified for the following populations: mild valve disease and moderate valve disease.</p><p>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.</p><p>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.</p><p>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.</p><p>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.</p><p>The quality of the evidence identified and the other limitations described in the <a href="#niceng208er7.s1.7.1.3">benefits and harms</a> 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.</p></div><div id="niceng208er7.s1.7.1.3"><h5>1.7.1.3. Benefits and harms</h5><p>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.</p><p>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.</p><p>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.</p><p>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.</p><p>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.</p><p>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.</p><p>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.</p><p>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 <a href="#niceng208er7.appj.et1">Appendix J.1</a> 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).</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="niceng208er7.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 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.</p><p>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.</p></div></div><div id="niceng208er7.s1.8"><h3>1.8. Recommendations supported by this evidence review</h3><p>This evidence review supports recommendation 1.4.1 and 3 research recommendations on monitoring where there is no current need for intervention.</p></div></div><div id="niceng208er7.rl.r1"><h2 id="_niceng208er7_rl_r1_">References</h2><dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>1.</dt><dd><div class="bk_ref" id="niceng208er7.ref1">Ahmed
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E, Fernandez-Golfin
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C, Moya-Mur
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JL, Gonzalez-Gomez
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A, Garcia-Martin
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RH, Shaw
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JL, Hauser
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TH, Markson
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A, Giustino
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G, Spagnolo
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P, Panoulas
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VF, Montorfano
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P, Wilczek
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K, Przybylski
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R, Glowacki
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J, Kukulski
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JF, Lerakis
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S, Stewart
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J, Jensen
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H, Henry
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TS, Ko
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JC, Gilard
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M, Bezon
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E, Jan
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V, Pennec
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A, Reeder
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BP, Moustakidis
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P, Pomerantz
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BJ, Vedala
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G, Scheri
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DA, Amdur
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JR, Mordini
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FE, Nagy
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AG, Babaoglu
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K, Saltik
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L, Oztunc
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M, Schulte
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PJ, Al Enezi
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F, Shaw
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F, De Chiara
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F, Crivellaro
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W, Mantero
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LM, De Cecco
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CN, Schoepf
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A, Mangold
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JA, Manisty
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G, Forte
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P, Stone
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GW, O’Gara
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PT, Marquis-Gravel
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A, Kusunose
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AW, Krieger
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C, Dulgheru
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C, Pierard
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LA, Lancellotti
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WL, Bonow
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RO, Borer
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JS, Ware
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R, Kracht
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PAM, Cramer
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MJ, Tietge
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LA, Klautz
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MM, Malhotra
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DW, Rader
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J, Piatkowski
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R, Grabowski
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M, Roik
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M, Scislo
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P, Majstrak
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JC, Branch
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W, Kim
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JB, Yang
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DH, Kim
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PC, Singh
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S, J
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DS, Perubhotla
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LM. Cardiac MR imaging in the evaluation of rheumatic valvular heart diseases. Journal of Clinical and Diagnostic Research. 2016; 10(3):AC06–AC09 [<a href="/pmc/articles/PMC4843347/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4843347</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/27134962" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27134962</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>48.</dt><dd><div class="bk_ref" id="niceng208er7.ref48">National Institute for Health and Care Excellence. Chronic heart failure in adults: diagnosis and management. NICE guideline 106. London. National Institute for Health and Care Excellence, 2018. Available from: <a href="https://www.nice.org.uk/guidance/ng106" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://www<wbr style="display:inline-block"></wbr>​.nice.org.uk/guidance/ng106</a></div></dd></dl><dl class="bkr_refwrap"><dt>49.</dt><dd><div class="bk_ref" id="niceng208er7.ref49">National Institute for Health and Care Excellence. Developing NICE guidelines: the manual [updated 2020]. London. National Institute for Health and Care Excellence, 2014. Available from: <a href="http://www.nice.org.uk/article/PMG20/chapter/1%20Introduction%20and%20overview" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">http://www<wbr style="display:inline-block"></wbr>​.nice.org.uk<wbr style="display:inline-block"></wbr>​/article/PMG20/chapter<wbr style="display:inline-block"></wbr>​/1%20Introduction%20and%20overview</a> [<a href="https://pubmed.ncbi.nlm.nih.gov/26677490" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26677490</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>50.</dt><dd><div class="bk_ref" id="niceng208er7.ref50">Nchimi
|
|
A, Dibato
|
|
JE, Davin
|
|
L, Schoysman
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L, Oury
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C, Lancellotti
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P. Predicting disease progression and mortality in aortic stenosis: A systematic review of imaging biomarkers and meta-analysis. Frontiers in Cardiovascular Medicine. 2018; 5:112 [<a href="/pmc/articles/PMC6113371/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6113371</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/30186838" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30186838</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>51.</dt><dd><div class="bk_ref" id="niceng208er7.ref51">NHS Improvement. 2017/18 Reference costs and guidance. 2018. Available from: <a href="https://improvement.nhs.uk/resources/reference-costs/" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://improvement<wbr style="display:inline-block"></wbr>​.nhs<wbr style="display:inline-block"></wbr>​.uk/resources/reference-costs/</a> Last accessed: 01/12/2020.</div></dd></dl><dl class="bkr_refwrap"><dt>52.</dt><dd><div class="bk_ref" id="niceng208er7.ref52">Oury
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|
C, Nchimi
|
|
A, Lancellotti
|
|
P, Bergler-Klein
|
|
J. Can blood biomarkers help predicting outcome in transcatheter aortic valve implantation?
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Frontiers in Cardiovascular Medicine. 2018; 5:31 [<a href="/pmc/articles/PMC5882866/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5882866</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/29644220" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29644220</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>53.</dt><dd><div class="bk_ref" id="niceng208er7.ref53">Owen
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A, Henein
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MY. Challenges in the management of severe asymptomatic aortic stenosis. European Journal of Cardio-Thoracic Surgery. 2011; 40(4):848–850 [<a href="https://pubmed.ncbi.nlm.nih.gov/21367614" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 21367614</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>54.</dt><dd><div class="bk_ref" id="niceng208er7.ref54">Oxorn
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|
D, Edelist
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G, Stafford Smith
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|
M. An introduction to transoesophageal echocardiography: II. Clinical applications. Canadian Journal of Anaesthesia. 1996; 43(3):278–294 [<a href="https://pubmed.ncbi.nlm.nih.gov/8829866" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 8829866</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>55.</dt><dd><div class="bk_ref" id="niceng208er7.ref55">Picano
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|
E, Pibarot
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P, Lancellotti
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|
P, Monin
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JL, Bonow
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RO. The emerging role of exercise testing and stress echocardiography in valvular heart disease. Journal of the American College of Cardiology. 2009; 54(24):2251–2260 [<a href="https://pubmed.ncbi.nlm.nih.gov/19958961" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19958961</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>56.</dt><dd><div class="bk_ref" id="niceng208er7.ref56">Prabhu
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MR. Trans-esophageal echocardiography for tricuspid and pulmonary valves. Annals of Cardiac Anaesthesia. 2009; 12(2):167 [<a href="https://pubmed.ncbi.nlm.nih.gov/19602749" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19602749</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>57.</dt><dd><div class="bk_ref" id="niceng208er7.ref57">Prior
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|
DL, Jaber
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WA, Homa
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DA, Thomas
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JD, Mayer Sabik
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E. Impact of tissue harmonic imaging on the assessment of rheumatic mitral stenosis. American Journal of Cardiology. 2000; 86(5):573–576 [<a href="https://pubmed.ncbi.nlm.nih.gov/11009285" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 11009285</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>58.</dt><dd><div class="bk_ref" id="niceng208er7.ref58">Quinones
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MA. Management of mitral regurgitation. Optimal timing for surgery. Cardiology Clinics. 1998; 16(3):421–435, viii [<a href="https://pubmed.ncbi.nlm.nih.gov/9742322" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 9742322</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>59.</dt><dd><div class="bk_ref" id="niceng208er7.ref59">Redfors
|
|
B, Furer
|
|
A, Lindman
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|
BR, Burkhoff
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D, Marquis-Gravel
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G, Francese
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DP
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et al. Biomarkers in aortic stenosis: A systematic review. Structural Heart. 2017; 1(1–2):18–30</div></dd></dl><dl class="bkr_refwrap"><dt>60.</dt><dd><div class="bk_ref" id="niceng208er7.ref60">Shavelle
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DM. Calcific aortic valve disease: imaging studies and therapeutic interventions. Journal of Investigative Medicine. 2007; 55(6):292–298 [<a href="https://pubmed.ncbi.nlm.nih.gov/17963678" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 17963678</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>61.</dt><dd><div class="bk_ref" id="niceng208er7.ref61">Sherifi
|
|
I, Omar
|
|
AMS, Varghese
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|
M, Weiner
|
|
M, Anyanwu
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A, Kovacic
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JC
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et al. Comparison of transesophageal and transthoracic echocardiography under moderate sedation for guiding transcatheter aortic valve replacement. Echo Research & Practice. 2018; 5(2):79–87 [<a href="/pmc/articles/PMC5987181/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5987181</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/29743180" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29743180</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>62.</dt><dd><div class="bk_ref" id="niceng208er7.ref62">Shub
|
|
C, Tajik
|
|
AJ, Holmes
|
|
DR, Jr., Reeder
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GS, Freeman
|
|
WK, Ilstrup
|
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DM
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et al. Doppler echocardiography in aortic stenosis: feasibility and clinical impact. International Journal of Cardiology. 1990; 28(1):57–66 [<a href="https://pubmed.ncbi.nlm.nih.gov/2365533" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 2365533</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>63.</dt><dd><div class="bk_ref" id="niceng208er7.ref63">Stewart
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RL, Chan
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KL. Management of asymptomatic severe aortic stenosis. Current Cardiology Reviews. 2009; 5(1):29–35 [<a href="/pmc/articles/PMC2803285/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC2803285</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/20066145" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20066145</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>64.</dt><dd><div class="bk_ref" id="niceng208er7.ref64">Suri
|
|
RM, Aviernos
|
|
JF, Dearani
|
|
JA, Mahoney
|
|
DW, Michelena
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|
HI, Schaff
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HV
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|
et al. Management of less-than-severe mitral regurgitation: should guidelines recommend earlier surgical intervention?
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European Journal of Cardio-Thoracic Surgery. 2011; 40(2):496–502 [<a href="https://pubmed.ncbi.nlm.nih.gov/21257316" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 21257316</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>65.</dt><dd><div class="bk_ref" id="niceng208er7.ref65">Taggu
|
|
W, Topham
|
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A, Hart
|
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L, Carr-White
|
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G, Sulke
|
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N, Patel
|
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NR
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|
et al. A cardiac sonographer led follow up clinic for heart valve disease. International Journal of Cardiology. 2009; 132(2):240–243 [<a href="https://pubmed.ncbi.nlm.nih.gov/18255174" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 18255174</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>66.</dt><dd><div class="bk_ref" id="niceng208er7.ref66">Tang
|
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Y, Green
|
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P, Maurer
|
|
M, Lazarte
|
|
R, Kuzniecky
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JR, Hung
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MY
|
|
et al. Relationship between accelerometer-measured activity and self-reported or performance-based function in older adults with severe aortic stenosis. Current Geriatrics Reports. 2015; 4(4):377–384 [<a href="/pmc/articles/PMC5033118/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5033118</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/27668146" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27668146</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>67.</dt><dd><div class="bk_ref" id="niceng208er7.ref67">Tanguturi
|
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VK, Hidrue
|
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MK, Picard
|
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MH, Atlas
|
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SJ, Weilburg
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JB, Ferris
|
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TG
|
|
et al. Variation in the echocardiographic surveillance of primary mitral regurgitation. Circulation: Cardiovascular Imaging. 2017; 10(8):e006495 [<a href="/pmc/articles/PMC5581547/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5581547</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/28774932" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28774932</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>68.</dt><dd><div class="bk_ref" id="niceng208er7.ref68">Tani
|
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LY, Minich
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LL, Pagotto
|
|
LT, Shaddy
|
|
RE. Usefulness of doppler echocardiography to determine the timing of surgery for supravalvar aortic stenosis. American Journal of Cardiology. 2000; 86(1):114–116 [<a href="https://pubmed.ncbi.nlm.nih.gov/10867108" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 10867108</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>69.</dt><dd><div class="bk_ref" id="niceng208er7.ref69">Tastet
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L, Simard
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L, Clavel
|
|
MA. Severe and asymptomatic aortic stenosis management challenge: Knowing that we do not really know. Current Treatment Options in Cardiovascular Medicine. 2017; 19(5):33 [<a href="https://pubmed.ncbi.nlm.nih.gov/28364395" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28364395</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>70.</dt><dd><div class="bk_ref" id="niceng208er7.ref70">Trinh
|
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B, Dubin
|
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I, Rahman
|
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O, Ferreira Botelho
|
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MP, Naro
|
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N, Carr
|
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JC
|
|
et al. Aortic volumetry at contrast-enhanced magnetic resonance angiography: Feasibility as a sensitive method for monitoring bicuspid aortic valve aortopathy. Investigative Radiology. 2017; 52(4):216–222 [<a href="/pmc/articles/PMC5339069/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5339069</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/27861233" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27861233</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>71.</dt><dd><div class="bk_ref" id="niceng208er7.ref71">Trochu
|
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JN, Dillon
|
|
R, Gustafsson
|
|
F, Mitchell
|
|
SA, Mitrovic
|
|
V, Alfieri
|
|
O. Mitral regurgitation - Unmet need for improved management strategies. IJC Heart and Vasculature. 2014; 5:26–41 [<a href="/pmc/articles/PMC5497153/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5497153</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/28785609" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28785609</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>72.</dt><dd><div class="bk_ref" id="niceng208er7.ref72">Velu
|
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JF, Baan
|
|
J, Jr., de Bruin-Bon
|
|
H, van Mourik
|
|
MS, Nassif
|
|
M, Koch
|
|
KT
|
|
et al. Can stress echocardiography identify patients who will benefit from percutaneous mitral valve repair?
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|
International Journal of Cardiovascular Imaging. 2019; 35(4):645–651 [<a href="/pmc/articles/PMC6482124/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6482124</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/30499057" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30499057</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>73.</dt><dd><div class="bk_ref" id="niceng208er7.ref73">Wystub
|
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N, Baz
|
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L, Mobius-Winkler
|
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S, Porner
|
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TC, Goebel
|
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B, Hamadanchi
|
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A
|
|
et al. Aortic annulus measurement with computed tomography angiography reduces aortic regurgitation after transfemoral aortic valve replacement compared to 3-D echocardiography: a single-centre experience. Clinical Research in Cardiology. 2019; 108(11):1266–1275 [<a href="https://pubmed.ncbi.nlm.nih.gov/30972479" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30972479</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>74.</dt><dd><div class="bk_ref" id="niceng208er7.ref74">Zaidi
|
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A, Ionescu
|
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A, Sharma
|
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R, Heatley
|
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M. Echocardiographic surveillance of aortic valve stenosis: towards a standardized approach. Journal of Heart Valve Disease. 2012; 21(6):707–713 [<a href="https://pubmed.ncbi.nlm.nih.gov/23409349" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 23409349</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>75.</dt><dd><div class="bk_ref" id="niceng208er7.ref75">Zilberszac
|
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R, Heinze
|
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G, Binder
|
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T, Laufer
|
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G, Gabriel
|
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H, Rosenhek
|
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R. Long-term outcome of active surveillance in severe but asymptomatic primary mitral regurgitation. JACC: Cardiovascular Imaging. 2018; 11(9):1213–1221 [<a href="https://pubmed.ncbi.nlm.nih.gov/30031699" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30031699</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>76.</dt><dd><div class="bk_ref" id="niceng208er7.ref76">Zilberszac
|
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R, Lancellotti
|
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P, Gilon
|
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D, Gabriel
|
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H, Schemper
|
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M, Maurer
|
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G
|
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et al. Role of a heart valve clinic programme in the management of patients with aortic stenosis. European Heart Journal Cardiovascular Imaging. 2017; 18(2):138–144 [<a href="https://pubmed.ncbi.nlm.nih.gov/27520802" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27520802</span></a>]</div></dd></dl></dl></div><div id="appendixesappgroup1"><h2 id="_appendixesappgroup1_">Appendices</h2><div id="niceng208er7.appa"><h3>Appendix A. Review protocols</h3><p id="niceng208er7.appa.et1"><a href="/books/NBK577827/bin/niceng208er7-appa-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 5. Review protocol: Monitoring of people with heart valve disease and no current indication for intervention</a><span class="small"> (PDF, 297K)</span></p><p id="niceng208er7.appa.et2"><a href="/books/NBK577827/bin/niceng208er7-appa-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 6. Health economic review protocol</a><span class="small"> (PDF, 219K)</span></p></div><div id="niceng208er7.appb"><h3>Appendix B. Literature search strategies</h3><p>
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<u>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</u>
|
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</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="#niceng208er7.ref49" rid="niceng208er7.ref49"><sup>49</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="niceng208er7.appb.et1"><a href="/books/NBK577827/bin/niceng208er7-appb-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">B.1. Clinical search literature search strategy</a><span class="small"> (PDF, 438K)</span></p><p id="niceng208er7.appb.et2"><a href="/books/NBK577827/bin/niceng208er7-appb-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">B.2. Health Economics literature search strategy</a><span class="small"> (PDF, 294K)</span></p></div><div id="niceng208er7.appc"><h3>Appendix C. Clinical evidence selection</h3><p id="niceng208er7.appc.et1"><a href="/books/NBK577827/bin/niceng208er7-appc-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 1. Flow chart of clinical study selection for the review of monitoring of people with heart valve disease and no current indication for intervention</a><span class="small"> (PDF, 158K)</span></p></div><div id="niceng208er7.appd"><h3>Appendix D. Clinical evidence tables</h3><p id="niceng208er7.appd.et1"><a href="/books/NBK577827/bin/niceng208er7-appd-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (152K)</span></p></div><div id="niceng208er7.appe"><h3>Appendix E. Forest plots</h3><div id="niceng208er7.appe.s1"><h4>E.1. Mild heart valve disease</h4><p>No evidence was identified for this stratum.</p></div><div id="niceng208er7.appe.s2"><h4>E.2. Moderate heart valve disease</h4><p>No evidence was identified for this stratum.</p></div><div id="niceng208er7.appe.s3"><h4>E.3. Severe heart valve disease</h4><p id="niceng208er7.appe.et1"><a href="/books/NBK577827/bin/niceng208er7-appe-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (172K)</span></p></div></div><div id="niceng208er7.appf"><h3>Appendix F. GRADE tables</h3><div id="niceng208er7.appf.s1"><h4>F.1. Mild heart valve disease</h4><p>No evidence was identified for this stratum.</p></div><div id="niceng208er7.appf.s2"><h4>F.2. Moderate heart valve disease</h4><p>No evidence was identified for this stratum.</p></div><div id="niceng208er7.appf.s3"><h4>F.3. Severe heart valve disease</h4><p id="niceng208er7.appf.et1"><a href="/books/NBK577827/bin/niceng208er7-appf-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (168K)</span></p></div></div><div id="niceng208er7.appg"><h3>Appendix G. Health economic evidence selection</h3><p id="niceng208er7.appg.et1"><a href="/books/NBK577827/bin/niceng208er7-appg-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (252K)</span></p></div><div id="niceng208er7.apph"><h3>Appendix H. Health economic evidence tables</h3><p>None</p></div><div id="niceng208er7.appi"><h3>Appendix I. Excluded studies</h3><div id="niceng208er7.appi.s1"><h4>I.1. Excluded clinical studies</h4><p id="niceng208er7.appi.et1"><a href="/books/NBK577827/bin/niceng208er7-appi-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (183K)</span></p></div><div id="niceng208er7.appi.s2"><h4>I.2. Excluded health economic studies</h4><p>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.</p><p>None.</p></div></div><div id="niceng208er7.appj"><h3>Appendix J. Research recommendations</h3><p id="niceng208er7.appj.et1"><a href="/books/NBK577827/bin/niceng208er7-appj-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">J.1. Asymptomatic mild or moderate heart valve disease</a><span class="small"> (PDF, 208K)</span></p><p id="niceng208er7.appj.et2"><a href="/books/NBK577827/bin/niceng208er7-appj-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">J.2. Symptomatic moderate heart valve disease</a><span class="small"> (PDF, 203K)</span></p><p id="niceng208er7.appj.et3"><a href="/books/NBK577827/bin/niceng208er7-appj-et3.pdf" class="bk_dwnld_icn bk_dwnld_pdf">J.3. Asymptomatic severe heart valve disease</a><span class="small"> (PDF, 196K)</span></p></div></div></div><div class="fm-sec"><div><p>Final</p></div><div><p>Intervention evidence review underpinning recommendation 1.4.1 and research recommendations 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&targetsite=external&targetcat=link&targettype=uri">Welsh Government</a>, <a href="http://www.scotland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Scottish Government</a>, and <a href="http://www.northernireland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&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> © NICE 2021.</div><div class="small"><span class="label">Bookshelf ID: NBK577827</span><span class="label">PMID: <a href="https://pubmed.ncbi.nlm.nih.gov/35143141" title="PubMed record of this title" ref="pagearea=meta&targetsite=entrez&targetcat=link&targettype=pubmed">35143141</a></span></div></div><div class="small-screen-prev"></div><div class="small-screen-next"></div></article><article data-type="table-wrap" id="figobniceng208er7tab1"><div id="niceng208er7.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/NBK577827/table/niceng208er7.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng208er7.tab1_lrgtbl__"><table><tbody><tr><th id="hd_b_niceng208er7.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><td headers="hd_b_niceng208er7.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Inclusion:</p>
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<p>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:
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<ul><li class="half_rhythm"><div>Mild</div></li><li class="half_rhythm"><div>Moderate</div></li><li class="half_rhythm"><div>Severe</div></li></ul>
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Severity assessed by echo and rated as per The British Society of Echocardiography. Other definitions will be accepted and downgraded for indirectness if appropriate.</p>
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<p>Exclusion:</p>
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<p>Children aged less than 18 years.</p>
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<p>Adults with congenital heart disease (excluding bicuspid aortic valves).</p>
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<p>Tricuspid stenosis and pulmonary valve disease.</p>
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<p>People who have had prior heart valve repair or replacement (transcatheter or surgical).</p>
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</td></tr><tr><th id="hd_b_niceng208er7.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Interventions</th><td headers="hd_b_niceng208er7.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Any of the following assessment strategies used for monitoring purposes, followed by appropriate valve intervention, in the specified population:</p>
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<p>Biomarkers (alone or in combination with echo):
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<ul><li class="half_rhythm"><div>BNP (B-type natriuretic peptide)</div></li><li class="half_rhythm"><div>NT-proBNP (N-terminal prohormone brain natriuretic peptide)</div></li></ul>
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Imaging:
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<ul><li class="half_rhythm"><div>Echocardiography</div></li><li class="half_rhythm"><div>CT (alone or in combination with echo)</div></li><li class="half_rhythm"><div>CMR (cardiovascular magnetic resonance; alone or in combination with echo)</div></li></ul>
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Patient reported outcome measures (PROMS; alone or in combination with echo), including:
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<ul><li class="half_rhythm"><div>EuroQol</div></li><li class="half_rhythm"><div>Minnesota Living With Heart Failure Questionnaire (MLHFQ)</div></li><li class="half_rhythm"><div>Veterans Specific Activity Questionnaire</div></li></ul>
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Other methods:
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<ul><li class="half_rhythm"><div>Electrocardiogram (ECG) (alone or in combination with echo)</div></li><li class="half_rhythm"><div>Clinical review only (no specific tests performed, as defined by the study authors)</div></li><li class="half_rhythm"><div>Exercise testing (for example Bruce protocol; alone or in combination with echo)</div></li></ul>
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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.</p>
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<p>Frequency will be categorised into the following groups:
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<ul><li class="half_rhythm"><div>More frequently than once a year (e.g. every 3 or 6 months)</div></li><li class="half_rhythm"><div>Once a year</div></li><li class="half_rhythm"><div>Less frequently than once a year (e.g. every 2, 3 or 5 years)</div></li></ul>
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Each monitoring test is a different strata and each frequency is a sub-analysis for each test.</p>
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</td></tr><tr><th id="hd_b_niceng208er7.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparisons</th><td headers="hd_b_niceng208er7.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Other active comparator listed above</p>
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<p>No monitoring (for example, tests only performed if new symptoms emerge/symptoms worsen)</p>
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</td></tr><tr><th id="hd_b_niceng208er7.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</th><td headers="hd_b_niceng208er7.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Primary outcomes:
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<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 (any validated measure)</div></li><li class="half_rhythm"><div>Hospitalisation for heart failure or other cardiac reason (e.g., for syncope in severe AS)</div></li></ul>
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Secondary outcomes:
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<ul><li class="half_rhythm"><div>New-onset atrial fibrillation</div></li></ul>
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If data are available, follow-up will be reported as a first preference at :
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<ul><li class="half_rhythm"><div>12 months for mild and moderate valve disease</div></li><li class="half_rhythm"><div>6 months for severe valve disease.</div></li></ul>
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Where multiple time-points are reported within a single study, only the time-point closest to that stated above will be extracted.</td></tr><tr><th id="hd_b_niceng208er7.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study design</th><td headers="hd_b_niceng208er7.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Randomised controlled trials (RCTs) and systematic reviews of RCTs. Published NMAs and IPDs will be considered for inclusion.</p>
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<p>If insufficient evidence is found from RCTs, non-randomised studies will be considered for inclusion.</p>
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<p>Important confounders NRS must be adjusted for:
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<ul><li class="half_rhythm"><div>Coronary artery disease</div></li><li class="half_rhythm"><div>Aortopathy in aortic valve disease</div></li></ul></p>
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</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng208er7tab2"><div id="niceng208er7.tab2" class="table"><h3><span class="label">Table 2</span><span class="title">Summary of studies included in the evidence review</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577827/table/niceng208er7.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng208er7.tab2_lrgtbl__"><table><thead><tr><th id="hd_h_niceng208er7.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study</th><th id="hd_h_niceng208er7.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intervention and comparison</th><th id="hd_h_niceng208er7.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><th id="hd_h_niceng208er7.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</th><th id="hd_h_niceng208er7.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comments</th></tr></thead><tbody><tr><td headers="hd_h_niceng208er7.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Ahmed 2017<a class="bibr" href="#niceng208er7.ref1" rid="niceng208er7.ref1"><sup>1</sup></a></p>
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<p>Retrospective review of medical records</p>
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<p>Medical records reviewed from 25th July 2007 to 6th December 2012</p>
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<p>N=300</p>
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<p>USA</p>
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</td><td headers="hd_h_niceng208er7.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p><b>Guideline adherent group [clinical review + echocardiography every 12 (±6) months] (n=202):</b> serial evaluation occurring every 12 (±6) months until aortic valve replacement or death during the follow-up.</p>
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<p>Appropriate serial evaluations required the following to be performed: comprehensive clinical evaluation that included description of presence or absence of cardiac symptoms, cardiopulmonary physical examination, and 2D and Doppler echocardiogram including assessment of left ventricular function and the haemodynamic severity of aortic stenosis, with documentation of the aortic valve area and either the peak aortic velocity or mean aortic valve gradient</p>
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<p><b>Guideline non-adherent group (n=98):</b> No definition for guideline non-adherence provided - could include those receiving follow-up with all required components more often than every 12 (±6) months, those receiving follow-up with all required components less often than every 12 (±6) months and also those receiving follow-up within 12 (±6) months but without all of the required components (comprehensive clinical review, cardiopulmonary physical examination and 2D and Doppler echocardiogram, as defined for the other group).</p>
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</td><td headers="hd_h_niceng208er7.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Severe asymptomatic aortic stenosis</p>
|
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<p>Mean age: 78 (11.6) vs. 79.8 (11.3) years</p>
|
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<p>Coronary artery disease, 47.5 vs. 48%</p>
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</td><td headers="hd_h_niceng208er7.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>All-cause mortality (median 4.5 years)</p>
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<p>Heart failure hospitalisation (median 4.5 years)</p>
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</td><td headers="hd_h_niceng208er7.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<ul><li class="half_rhythm"><div>Indirectness of interventions compared to the protocol</div></li><li class="half_rhythm"><div>All-cause mortality adjusted for: age, sex, coronary artery disease, atrial fibrillation, diabetes, peak aortic velocity, mean aortic valve gradient, aortic valve area, prior percutaneous coronary intervention, left ventricular ejection fraction and guideline adherence</div></li><li class="half_rhythm"><div>Heart failure hospitalisation was not adjusted, but similar at baseline for one of the key confounders listed: coronary artery disease</div></li><li class="half_rhythm"><div>Aortopathy was not mentioned in the study so unclear if groups were similar at baseline for this factor</div></li><li class="half_rhythm"><div>Note that the hazard ratios reported in the study were inverted as the paper reported the hazard ratios with the guideline adherent group as the control group, whereas we have extracted the guideline non-adherent group as the control group.</div></li></ul></td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng208er7tab3"><div id="niceng208er7.tab3" class="table"><h3><span class="label">Table 3</span><span class="title">Clinical evidence summary: Guideline adherent [clinical review + echocardiography every 12 (±6) months] vs. guideline non-adherent group</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577827/table/niceng208er7.tab3/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng208er7.tab3_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng208er7.tab3_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng208er7.tab3_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng208er7.tab3_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng208er7.tab3_1_1_1_2" style="text-align:left;vertical-align:bottom;">No of Participants (studies) Follow up</th><th id="hd_h_niceng208er7.tab3_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng208er7.tab3_1_1_1_3" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th><th id="hd_h_niceng208er7.tab3_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng208er7.tab3_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng208er7.tab3_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng208er7.tab3_1_1_1_5" id="hd_h_niceng208er7.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Risk with guideline non-adherent group</th><th headers="hd_h_niceng208er7.tab3_1_1_1_5" id="hd_h_niceng208er7.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Risk difference with Guideline adherent group (95% CI)</th></tr></thead><tbody><tr><td headers="hd_h_niceng208er7.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">All-cause mortality - HR (adjusted) 1 year</td><td headers="hd_h_niceng208er7.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>300</p>
|
|
<p>(1 study)</p>
|
|
<p>4.5 years</p>
|
|
</td><td headers="hd_h_niceng208er7.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
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<p>VERY LOW<sup>a</sup><sup>,</sup><sup>b</sup><sup>,</sup><sup>c</sup></p>
|
|
<p>due to risk of bias, indirectness, imprecision</p>
|
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</td><td headers="hd_h_niceng208er7.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>HR 0.65</p>
|
|
<p>(0.44 to 0.96)<sup>d</sup></p>
|
|
</td><td headers="hd_h_niceng208er7.tab3_1_1_1_5 hd_h_niceng208er7.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">20 per 1000</td><td headers="hd_h_niceng208er7.tab3_1_1_1_5 hd_h_niceng208er7.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>7 fewer per 1000</p>
|
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<p>(from 1 fewer to 11 fewer)<sup>e</sup></p>
|
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</td></tr><tr><td headers="hd_h_niceng208er7.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cardiac mortality</td><td headers="hd_h_niceng208er7.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng208er7.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng208er7.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng208er7.tab3_1_1_1_5 hd_h_niceng208er7.tab3_1_1_2_1 hd_h_niceng208er7.tab3_1_1_2_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;"></td></tr><tr><td headers="hd_h_niceng208er7.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Health-related quality of life (any validated measure)</td><td headers="hd_h_niceng208er7.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng208er7.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng208er7.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng208er7.tab3_1_1_1_5 hd_h_niceng208er7.tab3_1_1_2_1 hd_h_niceng208er7.tab3_1_1_2_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;"></td></tr><tr><td headers="hd_h_niceng208er7.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Heart failure hospitalisation - HR (not adjusted) 6 months</td><td headers="hd_h_niceng208er7.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>300</p>
|
|
<p>(1 study)</p>
|
|
<p>4.5 years</p>
|
|
</td><td headers="hd_h_niceng208er7.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊝⊝⊝</p>
|
|
<p>VERY LOW<sup>a</sup><sup>,</sup><sup>b</sup></p>
|
|
<p>due to risk of bias, indirectness</p>
|
|
</td><td headers="hd_h_niceng208er7.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>HR 0.6</p>
|
|
<p>(0.46 to 0.79)<sup>f</sup></p>
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</td><td headers="hd_h_niceng208er7.tab3_1_1_1_5 hd_h_niceng208er7.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">153 per 1000</td><td headers="hd_h_niceng208er7.tab3_1_1_1_5 hd_h_niceng208er7.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>58 fewer per 1000</p>
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<p>(from 30 fewer to 79 fewer)<sup>g</sup></p>
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</td></tr><tr><td headers="hd_h_niceng208er7.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">New-onset atrial fibrillation</td><td headers="hd_h_niceng208er7.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng208er7.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng208er7.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"></td><td headers="hd_h_niceng208er7.tab3_1_1_1_5 hd_h_niceng208er7.tab3_1_1_2_1 hd_h_niceng208er7.tab3_1_1_2_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;"></td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>a</dt><dd><div id="niceng208er7.tab3_1"><p class="no_margin">Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias</p></div></dd></dl><dl class="bkr_refwrap"><dt>b</dt><dd><div id="niceng208er7.tab3_2"><p class="no_margin">Downgraded by 1 increment as the interventions and comparisons in this study were indirect compared with the protocol - monitoring in the guideline adherent group may not have been 12 months in all patients and monitoring in the guideline non-adherent group was not defined and could have included various different strategies. There was also no information about aortopathy in the study, one of the confounders listed in the protocol.</p></div></dd></dl><dl class="bkr_refwrap"><dt>c</dt><dd><div id="niceng208er7.tab3_3"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs</p></div></dd></dl><dl class="bkr_refwrap"><dt>d</dt><dd><div id="niceng208er7.tab3_4"><p class="no_margin">The values reported in the paper (HR 1.54, 95% CI 1.04 to 2.29) were inverted in order to obtain the HR for the guideline adherent group vs. the non-adherent group to achieve the comparison of interest in the protocol</p></div></dd></dl><dl class="bkr_refwrap"><dt>e</dt><dd><div id="niceng208er7.tab3_5"><p class="no_margin">Control group risk at 1 year from survival curve used. A larger benefit (100 fewer per 1000) was observed when the control group risk at 4 years was used; however, this was not included in the report as the 1-year time-point was closest to the time-point of 6 months specified in the protocol</p></div></dd></dl><dl class="bkr_refwrap"><dt>f</dt><dd><div id="niceng208er7.tab3_6"><p class="no_margin">The values reported in the paper (HR 1.66, 95% CI 1.27 to 2.18) were inverted in order to obtain the HR for the guideline adherent group vs. the non-adherent group to achieve the comparison of interest in the protocol</p></div></dd></dl><dl class="bkr_refwrap"><dt>g</dt><dd><div id="niceng208er7.tab3_7"><p class="no_margin">Control group risk at 6 months from survival curve used. A larger benefit (185 fewer per 1000) was observed when the control group risk at 4 years was used; however, this was not included in the report as the time-point specified in the protocol was 6 months</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng208er7tab4"><div id="niceng208er7.tab4" class="table"><h3><span class="label">Table 4</span><span class="title">UK costs of monitoring tests for heart valve disease</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK577827/table/niceng208er7.tab4/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng208er7.tab4_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng208er7.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Resource</th><th id="hd_h_niceng208er7.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Unit cost</th><th id="hd_h_niceng208er7.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Source</th></tr></thead><tbody><tr><td headers="hd_h_niceng208er7.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">BNP</td><td headers="hd_h_niceng208er7.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">£22</td><td headers="hd_h_niceng208er7.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">CHF guideline (NG106)<a class="bibr" href="#niceng208er7.ref48" rid="niceng208er7.ref48"><sup>48</sup></a></td></tr><tr><td headers="hd_h_niceng208er7.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">NT-proBNP</td><td headers="hd_h_niceng208er7.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">£26</td><td headers="hd_h_niceng208er7.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">CHF guideline (NG106)<a class="bibr" href="#niceng208er7.ref48" rid="niceng208er7.ref48"><sup>48</sup></a></td></tr><tr><td headers="hd_h_niceng208er7.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Simple Echocardiogram<sup>(a)</sup></td><td headers="hd_h_niceng208er7.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">£108</td><td headers="hd_h_niceng208er7.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">NHS reference Costs 2017/18<a class="bibr" href="#niceng208er7.ref51" rid="niceng208er7.ref51"><sup>51</sup></a></td></tr><tr><td headers="hd_h_niceng208er7.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Complex Echocardiogram<sup>(b)</sup></td><td headers="hd_h_niceng208er7.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">£196</td><td headers="hd_h_niceng208er7.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">NHS reference Costs 2017/18<a class="bibr" href="#niceng208er7.ref51" rid="niceng208er7.ref51"><sup>51</sup></a></td></tr><tr><td headers="hd_h_niceng208er7.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Electrocardiogram or stress testing<sup>(c)</sup></td><td headers="hd_h_niceng208er7.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">£58</td><td headers="hd_h_niceng208er7.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">NHS reference Costs 2017/18<a class="bibr" href="#niceng208er7.ref51" rid="niceng208er7.ref51"><sup>51</sup></a></td></tr><tr><td headers="hd_h_niceng208er7.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Complex computerised Tomography (CT)<sup>(d)</sup></td><td headers="hd_h_niceng208er7.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">£162</td><td headers="hd_h_niceng208er7.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">NHS reference Costs 2017/18<a class="bibr" href="#niceng208er7.ref51" rid="niceng208er7.ref51"><sup>51</sup></a></td></tr><tr><td headers="hd_h_niceng208er7.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Cardiac Magnetic Resonance (CMR)<sup>(e)</sup></td><td headers="hd_h_niceng208er7.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">£399</td><td headers="hd_h_niceng208er7.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">NHS reference Costs 2017/18<a class="bibr" href="#niceng208er7.ref51" rid="niceng208er7.ref51"><sup>51</sup></a></td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">Source: Costs obtained from the CHF guideline<a class="bibr" href="#niceng208er7.ref48" rid="niceng208er7.ref48"><sup>48</sup></a> and NHS reference cost 2017/18<a class="bibr" href="#niceng208er7.ref51" rid="niceng208er7.ref51"><sup>51</sup></a>, cost codes were agreed by the committee.</p></div></dd></dl><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">Abbreviations: BNP: B-type natriuretic peptide.</p></div></dd></dl><dl class="bkr_refwrap"><dt>(a)</dt><dd><div id="niceng208er7.tab4_1"><p class="no_margin">Cost code RD51Aoutpatient</p></div></dd></dl><dl class="bkr_refwrap"><dt>(b)</dt><dd><div id="niceng208er7.tab4_2"><p class="no_margin">Cost code EY50Y outpatient</p></div></dd></dl><dl class="bkr_refwrap"><dt>(c)</dt><dd><div id="niceng208er7.tab4_3"><p class="no_margin">Cost obtained from the direct access to diagnostic service, cost code EC22Z</p></div></dd></dl><dl class="bkr_refwrap"><dt>(d)</dt><dd><div id="niceng208er7.tab4_4"><p class="no_margin">Cost code RD28Z</p></div></dd></dl><dl class="bkr_refwrap"><dt>(e)</dt><dd><div id="niceng208er7.tab4_5"><p class="no_margin">Cost weighted according to units of activity for the outpatient post-contrast only and pre- and post-contrast. Cost code RD09Z + RD10Z</p></div></dd></dl></dl></div></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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