Offer the treatment outlined in section 6.2.7 and If the person s eGFR is 45 ml/min/1.73 m2 or below, consider lower doses and/or slower titration of dose of ACE inhibitors or ARBs, mineralcorticoid receptor antagonists and 62.For people who have heart failure with reduced ejection fraction and chronic kidney disease with an eGFR below 30 ml/min/1.73 m2, the specialist heart failure MDT should consider liaising with a renal physician [2018] 63.Monitor the response to titration of medicines closely in people who have heart failure with reduced ejection fraction and chronic kidney disease, taking into account the increased risk of hyperkalaemia. [2018] Chronic Heart Failure Treating Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 6.3 Invasive procedures The update to the heart failure guideline includes topics where new evidence has emerged since the publication in 2010. A review of new evidence published after 2010 was carried out in order to determine whether any changes to current recommendations where likely to be required. The decision on which topics to include in the update of the guideline was made following consultation of the scope. This section with the exception of coronary revascularisation was not within the scope of the update. For more information on the following aspects of invasive procedures such as cardac transplantation please refer to appendix R in the 2003 guideline. 6.3.1 Coronary revascularisation Coronary artery disease (CAD) and heart failure often coexist and a majority of people with heart failure and reduced ejection fraction (HFREF) in the UK will have an ischaemic aetiology149 . Myocardial ischaemia is therefore often an important additional consideration in the management of people with heart failure. Concomitant severe CAD may warrant consideration for revascularisation with coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) in view of uncontrolled angina despite medical therapy, evidence of substantial myocardial ischaemia and viability or while undergoing valve intervention. Thus it might appear logical that coronary revascularisation, undertaken either surgically with CABG, or percutaneously with angioplasty, might result in improved outcomes when compared with medical therapy alone. However, the presence of left ventricular systolic dysfunction (LVSD) significantly increases the risk of both surgical and percutaneous revascularisation 373 and, if severe, may contraindicate CABG surgery altogether. Historically, however, there has only been anecdotal evidence of improvement in symptoms or left ventricular function following revascularisation in people with heart failure in the absence of the above special indications. Early randomised studies of coronary artery bypass grafting appeared to support revascularisation, whereby the patients who derived most benefit from surgical intervention were also those patients with impaired LV function, albeit in the context of selective randomisation. However, the landscape of cardiovascular management has changed through the prescription of newer drug therapies, routine acute angioplasty, changes in surgical interventions and the availability of device therapies such as implantable cardioverter defibrillators. It is therefore unclear if people with HFREF and severe CAD should be routinely offered myocardial revascularisation with CABG or PCI. Current practice varies widely depending on local interest and expertise as well as individual patient characteristics. This review was carried out to evaluate the emerging evidence in the field since the previous guidance was published regarding the clinical and cost effectiveness of coronary revascularisation in people with heart failure. 6.3.1.2 Review question: What is the clinical and cost effectiveness of coronary revascularisation with coronary artery bypass grafting or angioplasty in people with heart failure? For full details see review protocol in Appendix A. Table 68: PICO characteristics of review question Population People diagnosed with heart failure with reduced ejection fraction (HFREF). Intervention Coronary artery bypass graft surgery (CABG) CABG + ventricular reconstruction Percutaneous coronary intervention (PCI) Chronic Heart Failure Treating Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Comparison Medical management Outcomes CRITICAL All-cause mortality at 30 days (Time to event) All-cause mortality (Time to event) Quality of life at 12 months (Continuous) Unplanned hospitalisation at 12 months (Count rate) IMPORTANT Additional revascularisation events at 24 months (Count rate) Improvement of NYHA class at 12 months (Dichotomous) Improvement in ejection fraction at 12 months (Dichotomous) Adverse events - stroke at 12 months (Dichotomous) Study design Systematic Review RCT 6.3.1.3 Clinical evidence A search was conducted for randomised trials comparing the effectiveness of coronary revascularisation (CABG, CABG + ventricular reconstruction or PCI) with medical management in people with heart failure and reduced ejection fraction. Two studies (reported in 14 publications) were included in the review: HEART65 . These are summarised in Table 69 below. HEART compared an invasive strategy (angiography followed by PCI or CABG at the clinician s discretion) with medical management; STICH compared CABG and medical management. Evidence from these studies is summarised in the clinical evidence summaries below (Table 70 and Table 71). See also the study selection flow chart in Appendix C, forest plots in Appendix E, study evidence tables in Appendix F, GRADE tables in Appendix H and excluded studies list in Appendix I. Two studies were included within the 2003 CHF guideline.24, 75 and referred to narratively. These studies have been excluded within the current update as they no longer match the review protocol. For further explanation please see the excluded studies table (appendix I) and the Recommendations and link to evidence. Chronic Heart Failure Treating Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Table 69: Summary of studies included in the review Study Intervention and comparison Population Outcomes Comments HEART CABG plus medical therapy n = 30 PCI plus medical therapy n = 15 Medical therapy n = 64 Age, median (IQR): therapy 69 (60 74). %Male: CABG/PCI 94; medical therapy 93. NYHA class, n: I CABG/PCI - 13; medical therapy - II CABG/PCI 28; medical therapy - III/IV CABG/PCI 28; medical therapy 22. All-cause mortality; Dichotomous Quality of life difference between the groups reported only. Quality of life - Minnesota Living With Heart Failure Questionnaire; Mean difference between the groups reported only. Median follow-up of 4.9 years. Only 138 of the planned 800 patients were enrolled because of withdrawal of funding due to slow recruitment and because the larger STICH trial became available. CABG plus medical therapy n = 610 Medical therapy n = 602 Age year, median (IQR): medical therapy 59 (53-67). %Male: CABG 88; medical therapy 88. NYHA class, n: I CABG 65, medical therapy II IV CABG 545; medical therapy 528. All-cause mortality at 30 days and 5 years Quality of life Kansas City Cardiomyopathy Questionnaire. Adjusted mean difference Quality of life state index); Adjusted mean difference Quality of life Adjusted mean difference Quality of life Adjusted mean difference All-cause hospitalisations Median follow-up of 9.8 years. The use of implantable defibrillators was encouraged as part of standard medical therapy. Data was adjusted for patients for repeated assessments of quality of life. Chronic Heart Failure Treating Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Study Intervention and comparison Population Outcomes Comments Stroke Subsequent procedures CABG Subsequent procedures PCI No. in NYHA Class I Treating Heart Failure Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 6.3.1.3.1 CABG versus medical therapy Table 70: Clinical evidence summary: CABG + Medical therapy versus medical therapy Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relativ e effect CI) Anticipated absolute effects Risk with medical therapy Risk difference with CABG (95% CI) All-cause mortality 1212 MODERATEa due to risk of bias (from 27 fewer to 130 fewer) All-cause mortality at 30 days 1212 MODERATEa due to risk of bias (from 4 more to 70 more) Quality of life - EQ-5D Scale from: 0 to 1. LOWa,b due to risk of bias, imprecision The mean quality of life EQ-5D at 12 months in the control groups was The mean quality of life EQ-5D at 12 months in the intervention groups was Quality of life - EQ5D-VAS Scale from: 0 to 100 MODERATEa due to risk of bias The mean quality of life - EQ5D-VAS in the control groups was The mean quality of life - EQ5D-VAS in the intervention groups was Quality of life KCCQ (quality of life domain) Scale from: 0 to 100. MODERATE a due to risk of bias The mean quality of life - KCCQ at 12 months in the control groups was The mean quality of life - KCCQ at 12 months in the intervention groups was Quality of life - SF-12 (Physical component) MODERATEa due to risk of bias The mean quality of life SF-12 (physical component) at 12 months in the control groups was The mean quality of life SF-12 (physical component) at 12 months in the intervention groups was Treating Heart Failure Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relativ e effect CI) Anticipated absolute effects Risk with medical therapy Risk difference with CABG (95% CI) Quality of life - SF-12 (Mental Component) MODERATEa due to risk of bias The mean quality of life SF-12(mental component) at 12 months in the control groups was The mean quality of life SF-12 (mental component) at 12 months in the intervention groups was All-cause hospitalisations 1212 MODERATEb due to imprecision (from 34 fewer to 141 fewer) Subsequent procedures - CABG 1212 MODERATEa due to risk of bias Peto Odds Ratio (from 138 fewer to 153 fewer) Subsequent procedures - PCI 1212 LOWa,b due to risk of bias, imprecision (from 35 fewer to 8 more) NYHA class I 1212 LOWb,c due to imprecision, indirectness (from 21 more to 140 more) LOWa,b due to risk of (from 16 fewer to 47 more) Treating Heart Failure Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relativ e effect CI) Anticipated absolute effects Risk with medical therapy Risk difference with CABG (95% CI) bias, imprecision (a) Downgraded by 1 increment if majority of the evidence was rated high risk of bias, downgraded by 2 increments if majority of the evidence was rated very high risk of bias. (b) Downgraded by 1 increment if the confidence interval crossed one MID, downgraded by 2 increments if the confidence interval crossed both MIDs. (c) Downgraded by 1 increment due to indirectness of the outcome (protocol outcome improvement in NYHA class; extracted outcome no. in NYHA class I). 6.3.1.3.2 Invasive strategy (angiography with intent to revascularise (with CABG or PCI) versus medical therapy Table 71: Clinical evidence summary: Invasive strategy + medical therapy versus medical therapy Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with medical therapy Risk difference with invasive strategy (95% CI) All-cause mortality 136 VERY LOWa,b due to risk of bias, imprecision (from 121 fewer to 224 more) Quality of life - EQ-5D Scale from: 0 to 1. VERY LOWa,b due to risk of bias, imprecision c The mean quality of life EQ-5D at 6 months in the intervention groups was (0.14 lower to 0.10 higher) Quality of life - MLWHF Scale from: 0 to 105. VERY LOWa,b due to risk of bias, imprecision c The mean quality of life - MLWHF at 6 months in the intervention groups was (11.35 lower to 3.55 higher) (a) Downgraded by 1 increment if majority of the evidence was rated high risk of bias, downgraded by 2 increments if majority of the evidence was rated very high risk of bias. (b) Downgraded by 1 increment if the confidence interval crossed one MID, downgraded by 2 increments if the confidence interval crossed both MIDs. (c) Unable to calculate as the study only reported the overall mean difference. Treating Heart Failure Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Chronic Heart Failure Treating Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 6.3.1.4 Economic evidence Published literature No relevant health economic studies were identified. See also the health economic study selection flow chart in Appendix D. Unit costs The unit cost of the revascularisation procedures are shown in Table 72 below. The unit cost of all- cause hospitalisation is also provided in Table 73. Table 72: Cost of revascularisation procedures Procedure Code Average cost Source Coronary Artery Bypass Graft (without ventricular reconstruction) Complex Coronary Artery Bypass Graft (CC score 10+) 17,714 NHS reference costs Percutaneous Coronary Intervention Standard Percutaneous Transluminal Coronary Angioplasty (CC score 8-12+) 4,928 (a) NHS reference costs (a) Weighted cost using the activity reported for each of the included HRG codes. Table 73: Unit costs of all-cause hospitalisation Description Unit cost Source All-cause hospitalisation (non-elective) 2,930 NHS Reference costs 2014/15242 6.3.1.5 Evidence statements Clinical Two studies (reported in 14 publications) were identified for inclusion within the review: The evidence compared both an invasive strategy (angiography followed by PCI or CABG at the clinician s discretion) with medical management and CABG (plus medical management) with medical management alone. The evidence for the outcomes from one study (n=1212) comparing CABG (plus medical management) with medical management alone ranged from moderate to very low. This was due to a risk of bias and imprecision as a result of wide confidence intervals around the effect estimate. A single outcome (NYHA class I) was downgraded due to indirectness of the outcome. The outcome reported was the number of people in NYHA class I at the specified follow-up point of 4.7 years rather than the protocol outcome which was improvement in NYHA class. QoL as measured by the EQ-5D, EQ-5D VAS and KCCQ; all-cause hospitalisation and the need for subsequent procedures (CABG and PCI) showed clinically important benefit from CABG (plus medical management). The outcomes QoL (SF-12) and stroke showed no clinically important effect of CABG (plus medical management). All-cause mortality at 30 days showed a clinically important harm of CABG (plus medical management), while at the extended follow-up period of 9.8 years there was evidence of a Chronic Heart Failure Treating Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 clinical benefit of CABG (plus medical management). No evidence was found for the outcome improvement in ejection fraction. The evidence for the outcomes from one study (n=136) comparing an invasive strategy (angiography followed by PCI or CABG at the clinician s discretion) with medical management were all rated as very low. This was due to a risk of bias and imprecision as a result of wide confidence intervals around the effect estimate. Evidence for the outcome all-cause mortality showed a clinically important harm of the invasive strategy (associated with wide confidence intervals around the effect estimate) while evidence for the outcome QoL as measured by the EQ-5D and MLWHF showed no clinically important effect. No evidence was found for improvement in ejection fraction. Economic No relevant economic evaluations were identified. Chronic Heart Failure Treating Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 6.3.1.6 Recommendations and link to evidence Recommendations Do not routinely offer coronary revascularisation to people who have heart failure with reduced ejection fraction and coronary artery disease. [2018] Relative values of different outcomes The committee considered the following outcomes to be critical for this review: all-cause mortality (over study duration), all-cause mortality (at 30 days), quality of life, and all-cause hospitalisation. Data on all-cause mortality and hospitalisation were considered preferable to data limited to heart failure-related mortality and hospitalisations, as such data take into account the broader unintended consequences of the interventions (for example, an increase in mortality or hospitalisations due to adverse events or surgical complications). Improvement in ejection fraction and NYHA class, as well as additional revascularisation events and stroke, were also considered to be important for decision-making. For the comparison of CABG versus medical therapy, there was evidence on all outcomes except for improvement in ejection fraction. For the comparison of an invasive strategy versus medical therapy, there was only evidence for all-cause mortality (over study duration) and quality of life. Quality of the clinical evidence CABG versus medical therapy: The evidence for the outcome of all-cause mortality over the duration of the study was graded low quality due to risk of bias (differential cross-over rates in the intervention and control groups) and imprecision (based on the wide confidence intervals around the relative effect). However, the committee noted that the sensitivity analysis performed by the study authors suggested that the high rate of cross-over might have underestimated the beneficial effect of CABG on mortality, and also noted that the confidence intervals around the absolute effect were reasonably narrow and showed a clinically important benefit. The outcome of all-cause mortality at 30 days was graded moderate quality due to risk of bias (the cross-over rate being higher than the event rate). The evidence for the various quality of life measures were of moderate quality due to risk of bias (attrition). For all-cause hospitalisations, the evidence was graded moderate quality due to imprecision based on the wide confidence intervals around the relative risk estimate, but the committee noted that the confidence intervals around the absolute effect were reasonably narrow and showed a clinically important benefit. The evidence for subsequent CABG procedures was of moderate quality due to risk of bias (attrition), and for both subsequent PCI procedures and stroke was of low quality due to risk of bias (attrition) and imprecision. Finally, the evidence for improvement in NYHA class was graded as low quality due to imprecision and indirectness (the study only reported numbers in class I NYHA at the end of the trial rather than all of those whose NYHA class improved). Invasive strategy versus medical therapy: The evidence for all outcomes was of very low quality. For mortality over the duration of the study, the evidence had very serious imprecision and high risk of bias (unbalanced baseline characteristics between the groups). The quality of life evidence was downgraded for imprecision and risk of bias (lack of blinding). The committee noted that the trial upon which this evidence Chronic Heart Failure Treating Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Recommendations Do not routinely offer coronary revascularisation to people who have heart failure with reduced ejection fraction and coronary artery disease. [2018] was based, HEART,65 enrolled only 138 of the planned 800 patients and was thus underpowered. Other comparisons: There was no other evidence comparing PCI with medical therapy, or CABG plus ventricular reconstruction with medical therapy. Trade-off between clinical benefits and harms The committee discussed the evidence for an invasive strategy (angiography with intent to revascularise (with CABG or PCI)) versus medical therapy. The evidence on mortality suggested a possible clinical harm of an invasive strategy, but the committee was not confident in this evidence due to the very wide confidence intervals around the absolute risk difference (which range from clinically important benefit to clinically important harm) and the risk of bias. An invasive strategy appeared not to have a clinically important impact on quality of life, but again, the committee placed little weight on this evidence due to its very low quality. The committee discussed the evidence for CABG plus medical therapy, compared to medical therapy alone, and noted that CABG led to clinically important reductions in all-cause mortality and all-cause hospitalisations. The committee noted that this clinically important reduction in mortality was only evident at the extended follow-up period of 9.8 years, with 30 day mortality in patients receiving CABG being substantially higher than those receiving medical therapy alone (estimate of 24 more per 1000, ranging from 4 more to 70 more). CABG was also associated with clinically important improvements in NYHA class and quality of life measured with EQ5D and the Kansas City Cardiomyopathy Questionnaire, though a smaller, not clinically important difference was found using the SF-12. These were notable given the invasive nature of the CABG procedure and the extended recovery period. Randomisation to receive CABG also led to fewer subsequent CABG and PCI procedures compared with patients randomised to medical therapy alone, though for subsequent PCI procedures the evidence was imprecise. For stroke, there appeared to be no clinically important difference between the groups, though the confidence intervals ranged from a clinically important benefit to a clinically important harm and so the committee was not confident in the effect estimate. In weighing up the benefits and harms of revascularisation, the evidence suggested that overall and in the long term, CABG led to improvements in critical outcomes for the people enrolled in the trial, albeit with substantial 30 day mortality. However, the committee had 2 serious concerns about the applicability of the evidence to modern clinical management of heart failure patients in the UK. The committee considered that the evidence for CABG was not generalisable to the majority of heart failure with reduced ejection fraction (HFREF) patients. The committee noted the evidence was based on a single trial ) and that the characteristics of the patients in that trial were not representative of the HFREF population in the UK community. In particular, the committee noted the relatively young average age (60 in the CABG arm and 59 in the medical therapy arm). In contrast, the majority of ischemic HFREF patients in the UK are over 70 years of age, and older Chronic Heart Failure Treating Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Recommendations Do not routinely offer coronary revascularisation to people who have heart failure with reduced ejection fraction and coronary artery disease. [2018] patients tend to be frailer and would likely do less well following major surgery such as CABG. 149 After agreeing that CABG should not be routinely offered to typical HFREF patients, the committee discussed whether CABG would be appropriate for patients who present with risk profiles similar to the cohort assessed in STICH(ES). However, the committee was not convinced that the prognostic benefit demonstrated in STICH(ES) would be seen in modern practice. This was primarily because of the relatively small proportion of patients in the trial with Implantable Cardioverter Defibrillators (ICDs), which are now recommended for patients with heart failure and EF 35%.c The committee suggested that a higher rate of ICD usage may have improved the outcomes in the medical therapy arm. For the reasons above, the committee was not convinced that CABG would demonstrate the same beneficial effect in the current UK ischaemic HFREF population, and any possible benefit could be outweighed by an increased risk of serious adverse events during or post-surgery. In light of their concerns about generalisability and applicability of the evidence on CABG to the general HFREF population, the committee decided that CABG should not be routinely offered to patients with HFREF. However, the committee recognised that a proportion of patients with ischemic HFREF may derive substantial benefit from CABG in the long term. In particular, people with more severe coronary artery disease and in whom viability has been established may be more likely to obtain a greater benefit from CABG than the average benefit demonstrated in the STICH(ES) trial although the sub-study looking for an influence of viability on the surgical outcome was unable to confirm this. For HFREF patients with extensive coronary disease, who have a surgical risk profile similar to the patients enrolled in the STICH(ES) trial, clinicians may wish to discuss the evidence on CABG as part of shared decision making regarding treatment options. That this is an area of significant uncertainty should be openly discussed with patients. In any shared-decision making with patients about CABG, a thorough discussion about the potential risks and benefits will be essential to enable informed consent. This discussion should go beyond the immediate post-surgery risks. In particular, clinicians should address any misconception that so long as a patient pulls through the surgery, their heart failure will necessarily be fixed , as some patients will have an excellent symptomatic response and others far less. It should be emphasised that where benefit accrues from CABG this only occurs after more than 5 years, and that to date it is difficult to identify which individuals will do well. The committee noted that in the UK, PCI is used more commonly than CABG for revascularisation, due to a lower rate of complications and shorter recovery period. However, the committee recognised that in heart failure, there is no RCT evidence on the effectiveness of PCI. A UK study of PCI in patients with HFREF (EF < 30%), extensive coronary disease and viable myocardium (in 30% of dysfunction segments) is currently underway c See TA314 Implantable cardioverter defibrillators and cardiac resynchronisation therapy for arrhythmias and heart failure Chronic Heart Failure Treating Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Recommendations Do not routinely offer coronary revascularisation to people who have heart failure with reduced ejection fraction and coronary artery disease. [2018] ). When considering the totality of the evidence for revascularisation, the committee decided that neither CABG nor PCI should be routinely offered to patients with HFREF. This was based on the absence of RCT level evidence supporting the use of PCI in HFREF, and the concerns regarding the applicability of the evidence on CABG in HFREF. Trade-off between net clinical effects and costs No previously published economic evaluations were identified assessing the cost-effectiveness of coronary revascularisation in a heart failure population; therefore the unit costs of CABG and PCI were presented to the committee for consideration of cost effectiveness alongside the clinical evidence. The committee discussed that a CABG in people with heart failure would be complex and associated with a prolonged length of stay in both the intensive care unit (ICU) and inpatient ward. The average length of stay reported in the STICH trial was 9 days. Taking these factors into account the committee agreed that the average unit cost for CABG would be at the higher end of the scale in people with heart failure of 17,714 [NHS reference cost HRG ED26A]. The committee also highlighted that additional costs would be incurred prior to a person receiving CABG due to the high cost imaging (perfusion cardiac MRI and/or an invasive angiography) required to determine the location and extent of revascularisation required and the feasibility of the procedure, further increasing costs. As mentioned in the trade-off between clinical benefits and harms section above, the population in the STICH(ES) trial is younger than the typical heart failure population. The committee discussed that there is an increased risk of mortality and complications of surgery with age and therefore agreed that CABG is unlikely to benefit the typical HF-REF population. Due to the high costs of the procedure, as well as the likely incurrence of additional costs of complications, the committee agreed that CABG is highly unlikely to be cost effective in the current UK heart failure population. The committee were uncertain about the cost effectiveness of CABG in a population that reflects those included in the STICH(ES) trial. The committee discussed that due to the higher uptake of ICDs nowadays, especially in younger patients, the survival benefit of CABG compared to those receiving medical therapy alone found in STICH(ES) could be negated and the average QALY gain could be low. However, the true effect of this is uncertain. The committee agreed that in exceptional cases CABG may be cost effective for a small proportion of people (the committee estimate less than 1%) with ischaemia and with characteristics similar to those in the STICH trial. The committee discussed that CABG should be decided on a case by case basis, resembling current clinical practice, and therefore agreed on a do not routinely offer recommendation. The cost of a PCI is much lower than CABG at 4,928. However, as there was no clinical evidence for PCI alone, the committee could not determine the cost-effectiveness of PCI. The committee were aware that the cost- effectiveness of PCI will be assessed in a health technology assessment alongside the REVIVE trial and therefore did not consider it important to make a research recommendation in this area. Chronic Heart Failure Treating Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Recommendations Do not routinely offer coronary revascularisation to people who have heart failure with reduced ejection fraction and coronary artery disease. [2018] Other considerations The committee discussed current practice regarding coronary revascularisation for HFREF in the UK, and the potential impact of their recommendation. In the 2010 guideline, the recommendation was that coronary revascularisation should not be routinely considered. This was based on an evidence review conducted for the 2003 guideline, and the review was not updated in 2010. The new recommendation clarifies that coronary revascularisation should not be routinely offered to patients with HFREF without angina, but allows clinicians to use their professional judgement to consider whether coronary revascularisation may be appropriate for each patient on a case by case basis. The committee considered that the new recommendation would be unlikely to have a significant resource impact as they do not consider that it will change current practice. The 2003 CHF guideline made reference to 2 papers narratively regarding this review question. These studies have been excluded within the current review as they were carried out previous to 2001 when new guidance regarding the use of beta-blockers for the management of HF were introduced. The committee agreed that this change in management was likely to have had an effect on treatment strategies overall and therefore only wished to consider studies carried out after 2001. Chronic Heart Failure Treating Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 6.3.2 Recommendations for invasive procedures 6.3.2.1 Implantable cardioverter defibrillators and cardiac resynchronisation therapy See NICE s technology appraisal guidance on implantable cardioverter defibrillators and cardiac resynchronisation therapy for arrhythmias and heart failure 6.3.2.2 Coronary revascularisation 64.Do not routinely offer coronary revascularisation to people who have heart failure with reduced ejection fraction and coronary artery disease. [2018] 6.3.2.3 Cardiac transplantation 65.Specialist referral for transplantation should be considered for people with severe refractory symptoms or refractory cardiogenic shock [2003] Chronic Heart Failure Rehabilitation in chronic heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 7 Rehabilitation in chronic heart failure The update to the heart failure guideline includes topics where new evidence has emerged since the publication in 2010. A review of new evidence published after 2010 was carried out in order to determine whether any changes to current recommendations where likely to be required. The decision on which topics to include in the update of the guideline was made following consultation of the scope. In this section new evidence on home versus centre based cardiac rehabilitation was reviewed. 7.1 Home-based versus centre-based rehabilitation The importance of rehabilitation therapy has been recognised for many years in the management of patients post-myocardial infarction. Many patients with heart failure, especially those with heart failure with reduced ejection fraction (HFREF) have an underlying basis in myocardial iscahemia and previous myocardial events. A number of studies have investigated whether rehabilitation techniques deliver similar benefits in patients with heart failure to those achieved in patients after a myoacrdila infarct. The organisation of heart failure services is evolving to favour home and community-based interventions as opposed to hospital-based provision. There are known inequalities in access to hospital-based rehabilitation services across the UK. This question investigated whether home-based rehabilitation services could deliver similar outcomes to hospital- based rehabilitation services. 7.1.2 Review question: What is the clinical and cost effectiveness of home-based versus centre- based rehabilitation (that includes an exercise element) for people with heart failure (HF)? For full details see review protocol in appendix A. Table 74: PICO characteristics of review question Population People diagnosed with HF Intervention Home-based cardiac rehabilitation (CR) service. Programme must be structured, with clear objectives for the participants, and include a monitoring component. Programmes will be included whether they are based solely on exercise or include such as education and/or psychological support other intervention elements (comprehensive cardiac rehabilitation). No minimum duration of intervention. Comparison Centre-based CR service (including community based rehabilitation service and hospital based rehabilitation service). Programme must be structured, with clear objectives for the participants, and include a monitoring component. Programmes will be included whether they are based solely on exercise or include other intervention elements such as education and/or psychological support ( comprehensive CR ). Outcomes CRITICAL All-cause mortality CV mortality Health-related quality of life All cause hospitalisation HF-related hospitalisation IMPORTANT Exercise capacity Chronic Heart Failure Rehabilitation in chronic heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Adverse events (withdrawal from the exercise programme) Adherence (including maintenance of exercise/physical activity) Health service use Study design RCTs (individual or cluster level, including parallel group, cross-over or quasi- randomised designs). 7.1.3 Clinical evidence The following review was conducted by the University of Exeter Medical School Cochrane Cardiac Rehabilitation group as part of a second update to the Cochrane systematic review Home versus centre-based Cardiac Rehabilitation 13 in accordance with NGC methodology. A search was conducted for randomised trials directly comparing home- with centre-based cardiac rehabilitation for people with heart failure. these are summarised in Table 75 below. Evidence from these studies is summarised in the clinical evidence summary below in Table 76. See also the study selection flow chart in Appendix C, forest plots in Appendix E, study evidence tables in Appendix F, GRADE tables in Appendix H and excluded studies list in Appendix I. All of the studies compared home-based exercise training (which included aerobic circuit training and walking) with centre-based (which included aerobic circuit training, treadmill walking and cycling). Summary of included studies Table 75: Summary of RCTs included in the review Study Intervention and comparison Population Outcomes Comments Cowie (Cowie , Cowie ) Intervention: aerobic circuit (guided by DVD and booklet), 2 weekly phone calls by a physiotherapist; no other treatments reported Frequency: twice per week Duration: 1 hour Intensity: 40-60% heart rate reserve or Borg 12-13, Control: As home but supervised (led by physiotherapist) and hospital-based; no other treatments n = 60 Age (range): 65.8 Gender: 85% male NYHA class II and Mean ejection fraction: NR (systolic dysfunction) Family origin not reported Single centre UK Mortality QoL(MLWHF) Exercise capacity (ISWT) Adherence Maximum duration of follow-up: 2 months The study reported median values only for the outcome QoL (MLWHF), therefore it has not been included in the analysis Daskapan Intervention: Outdoor Walking & n = 29 Mortality Exercise capacity Maximum duration of follow-up: Chronic Heart Failure Rehabilitation in chronic heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Study Intervention and comparison Population Outcomes Comments weekly phone calls provided; no other treatments reported Frequency: 3 sessions per week Duration: 45 minutes Intensity: up to 60% peak heart rate (RPE 12-16) Control: As home but supervised laboratory based (treadmill walking) Age (mean SD): Gender: 73% male NYHA class II and Mean ejection Family origin not reported Single centre Turkey Adherence Data obtained on mortality by personal contact Hwang Intervention: Aerobic and strength training exercises delivered via a synchronous videoconferencing platform across the internet. Participants were provided with additional home exercises to be undertaken three times per week. Educational topics were delivered as electronic slide presentations with a 15 minute interaction period held prior to the exercise session to discuss this. Frequency: 2 sessions per week Duration: 60 minutes Intensity: RPE 9-13 (commencing at very light and progressing to somewhat hard). Exercise prescription was tailored to the participants goal. Control: As home- based Age (mean SD): Gender: 79% male NYHA class II-III: LVEF (mean SD): Family origin: 92% Caucasian Australia Mortality Exercise capacity: o 6 minute walk distance o 10m walk test (comfortable and fast) QoL (EQ-5D) QoL (MLWHFQ) Adherence Maximum duration of follow-up: 24 weeks Chronic Heart Failure Rehabilitation in chronic heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Study Intervention and comparison Population Outcomes Comments telerehabilitation but centre-based led by physiotherapists Karapolat Intervention: Walking with pedometer, weekly phone calls provided; breathing and flexibility exercises Frequency: 3 sessions per week Duration: 45-60 minutes Intensity: 60-70% heart rate reserve, level 13-15 on the Borg scale Control: As home but supervised treadmill walking in rehabilitation centre with breathing and flexibility exercises N = 74 Age (mean SD): Intervention: Control: Gender (% male): NYHA class II-III: Mean ejection fraction: Not reported Family origin not reported Single centre Turkey Mortality Exercise capacity Adherence Maximum duration of follow-up: Piotrowicz (Piotrowicz ) Intervention: Continuous walking on level ground and an education programme detailing how to measure HR, BP and body weight; how to evaluate signs and symptoms. All participants received psychological support. The home based group received an EHO 3 device and a mobile phone. Before beginning a training session, participants used the mobile phone to answer symptom based questions. A resting ECG was transmitted to the monitoring centre in order to establish that exercise was n = 152 Age (mean): Gender: male Control: 95% male NYHA class II-III: Mean ejection fraction: Home group: Centre group: Family origin not reported Single centre Poland Mortality Exercise capacity Exercise capacity Adherence Maximum duration of follow-up: 2 months Chronic Heart Failure Rehabilitation in chronic heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Study Intervention and comparison Population Outcomes Comments safe to continue. sessions per week Duration: 20-45 minutes Intensity: Individually tailored Control: As home but supervised in an outpatient setting, with interval training using a cycle ergonometer Rehabilitation in chronic heart failure Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Table 76: Clinical evidence summary: Home-based exercise training versus centre-based exercise training Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with centre-based exercise training Risk difference with home-based exercise training (95% CI) All-cause mortality 335 months VERY LOWa,b due to risk of bias, imprecision Peto odds ratio (from 18 fewer to 82 more) Quality of life - SF-36 Physical component summary (PCS) months LOWa due to risk of bias The mean SF-36 PCS in the centre- based exercise training groups was The mean SF-36 PCS in the home-based exercise training groups was (5.45 lower to 4.33 higher) Quality of life - SF-36 Mental component summary (MCS) months VERY LOWa,b,c due to risk of bias, inconsistency, imprecision The mean SF-36 MCS in the centre- based exercise training groups was The mean SF-36 MCS in the home-based exercise training group was (5.74 lower to 7.18 higher) Quality of life EQ-5D utility HIGH f The mean EQ-5D utility in the home- based exercise training group was (0.16 lower to 0.04 higher) Quality of life - MLWHFQ MODERATEb due to imprecision f The mean MLWHFQ in the home-based exercise training group was (17 lower to 9 higher) Exercise capacity - ISWT 30 VERY LOWa,b due to risk of bias, imprecision The mean exercise capacity - ISWT in the centre-based exercise training groups was The mean exercise capacity - ISWT in the home-based exercise training group was (104.42 lower to 116.22 higher) Exercise capacity - 201 e The mean exercise capacity 6MWT in Rehabilitation in chronic heart failure Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with centre-based exercise training Risk difference with home-based exercise training (95% CI) MODERATEa due to risk of bias the home-based exercise training groups was (23.52 lower to 25.16 higher) Exercise Capacity months LOWa due to risk of bias The mean exercise capacity VO2max in the centre-based exercise training groups was The mean exercise capacity VO2max in the home-based exercise training groups was (1.27 lower to 1.46 higher) Exercise capacity 10 metre walk test (fast) HIGH The mean exercise capacity 10 metre walk test (fast) in the intervention group was months VERY LOWa,b due to risk of bias, imprecision (from 55 more to 234 more) Adherence to intervention VERY LOWa,b due to risk of bias, imprecision (from 304 fewer to 288 more) Adherence to intervention VERY LOWa,b due to risk of bias, imprecision (from 94 fewer to 479 more) Adherence to intervention MODERATEa due to risk of bias (from 161 fewer to 134 more) Rehabilitation in chronic heart failure Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with centre-based exercise training Risk difference with home-based exercise training (95% CI) Adherence to intervention VERY LOWa,b due to risk of bias, imprecision (from 102 more to 338 more) Adherence to intervention (Hwang MODERATEb due to imprecision f The mean adherence to intervention in the intervention group was (a) 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. (b) Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs. (c) Heterogeneity, I2=54%, downgraded by 1 increment. (d) The outcome data for adherence to intervention was not meta-analysed as there was a significant degree of variation in the methods of obtaining this information across studies. (e) Unable to estimate as one of the studies included in the meta-analysis only reported the mean difference. The outcome has therefore been analysed using generic inverse variance. (f) Unable to calculate as the study only reported a mean difference. Chronic Heart Failure Rehabilitation in chronic heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 7.1.4 Economic evidence Published literature One health economic study was identified with the relevant comparison and has been included in This is summarised in the health economic evidence profile below (Table 77) and the health economic evidence table in appendix G. See also the health economic study selection flow chart in appendix D. Rehabilitation in chronic heart failure Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Table 77: Health economic evidence profile: Hospital vs home rehabilitation Study Applicability Limitations Other comments Incremental cost Incremental effects Cost effectiveness Uncertainty [UK] Partially applicable(a) Very serious limitations (b) Comparative costing from UK NHS perspective Population: people with heart failure on optimised medication dosages, clinically stable for one month. Two comparators: 1. Hospital training 2. Home training Follow-up: 5 years 2-1: 480 (c) n/a n/a None. Abbreviations: ICER: incremental cost-effectiveness ratio; QALY: quality-adjusted life years. (a) Does not include any health outcomes. (b) Small sample size, which has significant impact on cost per patient for the home training group. The baseline patient characteristics are not typical with a very high proportion of males. Furthermore, the usual care group nearly 10 years younger than hospital group suggesting there is selection bias. No discounting was undertaken. (c) An additional comparator of usual care was also included in the study. Both hospital training and home training were cost saving compared to usual care. For further detail see full evidence table in appendix G. Chronic Heart Failure Rehabilitation in chronic heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 7.1.5 Evidence statements Clinical Five studies (8 publications) were identified for inclusion within the review. All of the studies compared home-based exercise training with centre-based exercise training supervised by a healthcare professional. The included evidence ranged from high to very low quality. Outcomes were downgraded due to a high or very high risk of bias, imprecision due to wide confidence intervals surrounding the point estimate and inconsistency due to heterogeneity between the effect estimates for meta analysed outcomes. Five studies reported the outcome all-cause mortality (n=335) which showed no clear clinical effect of home-based exercise training with the confidence interval ranging from a decrease and increase in all-cause mortality For the outcome QoL (as measured by the SF- 36), 2 studies (n=161) showed that there was no clinically important effect of home-based exercise training on either the physical or mental component summaries. A further single study (n=49) also showed no clinical effect of home-based exercise training on either the EQ-5D utility score or the MLWHFQ. This was also the case for exercise capacity as measured by the 6 minute walk test (n=201), the incremental shuttle walk test (n=161), VO2max (n=221) and the 10 metre walk test (fast) (n=49). The outcome, number of people completing the exercise programmes (n=295) showed a clinically important benefit of home-based exercise training. For adherence to the intervention the outcome data reported by each study was not meta-analysed due to considerable variation in the manner in which it was reported across studies. The direction and magnitude of effect varied between studies with both a clinical benefit and clinical harm being shown. None of the studies reported the outcome hospitalisations (both all-cause and HF-related), cardiovascular mortality and health service use. Economic One comparative cost analysis found that home training was more costly than hospital training for delivering rehabilitation (cost difference: 480 per patient). This analysis was assessed as partially applicable with very serious limitations. 7.1.6 Recommendations and link to evidence Recommendations Offer people with heart failure a personalised, exercise-based cardiac rehabilitation programme, unless their condition is unstable. The programme: should be preceded by an assessment to ensure that it is suitable for the person should be provided in a format and setting (at home, in the community or in the hospital) that is easily accessible for the person should include a psychological and educational component may be incorporated within an existing cardiac rehabilitation programme should be accompanied by information about support available from healthcare professionals when the person is doing the programme. Relative values of different outcomes The committee considered all-cause mortality, quality of life and all-cause hospitalisation to be the critical outcomes for this review. Data on all-cause mortality and hospitalisation were considered preferable to data limited to heart failure (HF) Chronic Heart Failure Rehabilitation in chronic heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 or cardiovascular related hospitalisations and mortality, as such data take into account the broader unintended consequences of the interventions (for example, an increase in hospitalisations due to adverse events). Cardiovascular mortality, heart- failure related hospitalisation, exercise capacity, health service use, and withdrawal from/adherence to the programme, were considered to be important for decision- making. No evidence was identified for the outcomes cardiovascular mortality, health-service use and hospitalisation (both all-cause and HF-related). Quality of the clinical evidence Five studies were identified for inclusion within the review. For the critical outcome of mortality the evidence was rated as very low quality due to risk of bias and imprecision as a result of wide confidence intervals surrounding the point estimate. For quality of life, which was also a critical outcome, the quality of the evidence ranged from high to very low depending on the scale used for measurement. The SF- 36 physical component summary and mental component summary were rated as low and very low quality respectively. This was again due to risk of bias, imprecision and heterogeneity in the results reported by the studies. For the EQ-5D utility score the evidence was rated as high quality; for the MLWHFQ the evidence was rated as moderate quality, due to imprecision. Several measures of exercise capacity were reported by the studies; these included the incremental shuttle walk test (ISWT), the 6 minute walk test (6MWT), VO2 max and the 10 metre walk test (fast). The quality of these outcomes ranged from very low to high quality, with outcomes being downgraded for risk of bias and imprecision. All of the included studies reported adherence to the intervention, which ranged in quality from moderate to very low. The outcome data reported by each study was not meta-analysed due to the significant degree of variation in the methods of obtaining this information across studies. The committee also noted that the subjective nature of the adherence data, when self-reported by people in a home- based exercise programme, meant that it was potentially less reliable. The majority of trials poorly reported details of sequence generation, concealment of the random allocation sequence and blinding of outcome assessment; contributing to the overall high risk of bias in the body of evidence for all outcomes. Losses to follow-up, which varied widely across studies, also contributed to the risk of bias for some outcomes. Trade-off between clinical benefits and harms There was no consistent evidence of a clinically important difference in exercise capacity between home-based and centre-based rehabilitation when quantified via the ISWT, 6MWT, VO2 max and 10 metre walk test (fast). A similar result was seen for quality of life, with no consistent evidence of a clinically important difference between home and centre-based rehabilitation. This was also the case for adherence, with no consistent clinical benefit being observed. The committee noted that this evidence was more challenging to interpret as variation in the way this data was reported across studies prohibited the meta-analysis of these results. In addition to this the committee noted that self-reported adherence by participants enrolled in a home-based exercise programme were likely to be less reliable due to the subjective nature of the reporting. Similarly, no clinically important difference in mortality was seen between the groups, although this estimate was seriously imprecise, with confidence intervals ranging from a clinically important reduction to a clinically important increase in deaths in the home-based groups. Based on the clinical evidence reviewed, the committee agreed that home- and centre-based forms of cardiac rehabilitation seem to be similarly effective for patients with heart failure. The committee noted that the body of evidence was small (5 trials of 335 patients) and the majority of outcomes were at high risk of bias. The patient populations included in the trials were also much younger than the typical heart failure patients Chronic Heart Failure Rehabilitation in chronic heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 in the UK. However, the committee agreed that this was common in rehabilitation trials and wasn t specific to home versus centre-based trials. The committee acknowledged that the findings of this review which suggested that no clear difference could be demonstrated between home- and centre-based programmes. The committee also noted that findings in younger populations might also not translate to more typical older patient populations. The committee was also conscious that the critical outcome of hospitalisation was not reported by any of the included studies. The evidence on patient completion suggested a clinically important increase in completion rates in the home-based groups compared to the centre-based groups. For some patients, the burden of travelling to a centre for rehabilitation and/or dislike of exercising in a group setting may be a substantial barrier to participation in centre-based programmes. For these patients, home-based rehabilitation may be a more attractive and achievable option. Similarly, a patient representative expressed his view that the main concern of many younger patients with heart failure is to learn and understand their limits with professional supervision, to enable them to then exercise safely and comfortably alone. The committee expressed its concern about the continuing low uptake of rehabilitation since the previous guideline52 and agreed that there may be inequalities in the ability to access rehabilitation, especially for older, frailer patients with heart failure. The committee agreed that the delivery of home-based rehabilitation may increase access and uptake, which is a major priority in the management of heart failure. The committee considered that even a modest increase had the potential to result in a marked improvement in patient outcomes at the population level. The committee also discussed the potential downsides of a home-based programme, including: the loss of face-to-face support and encouragement from health professionals and peers, especially compared with a group programme; increased feeling of isolation for some patients; the potential for reduced adherence among some patients, and for patients to experience technological and comprehension barriers to full participation, which may not be picked up in patient self-reports. On balance, the committee agreed that choice of participating in a more traditional and supervised centre-based programme or a home-based programme should ideally reflect the preference of the individual patient. The committee therefore decided to maintain the current recommendation to offer cardiac rehabilitation to heart failure patients, but removed the limitations on the mode of delivery. The committee agreed that the setting and format of the programme should facilitate the person s ability to access the programme. The committee noted that several comprehensive, evidence-based, home-delivered cardiac rehabilitation programmes are currently available. These programmes typically involve an overarching self-help manual outlining the programme, and include an exercise training element (such as open air walking or indoor exercises using a DVD), as well as educational (for example, medications, symptom monitoring and help-seeking) and psychological (for example, managing stress and anxiety) components. The programmes are overseen by a trained healthcare professional who patients can contact for further advice. The specific home-based programmes in the included studies were as follows: three studies were based on outdoor walking training, with the addition of flexibility and breathing exercises (1 study), and the addition of telephone conversations with a psychologist (1 study); one study was based on a DVD of functional aerobic exercises interspersed with active recovery. Chronic Heart Failure Rehabilitation in chronic heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 All home-based programmes in the included studies were accompanied by tele- monitoring and written information, and some programmes included the use of heart rate monitors and pedometers. One programme utilised remote monitoring equipment (an EHO 6 device enabling the recording and transmission of an ECG via a mobile phone). The committee discussed how a home-based programme would be delivered and how professional support would be accessed in the NHS context. The committee did not expect a home-based programme would involve regular face-to-face contact with health professionals and agreed the use of expensive equipment would not be required. The committee agreed that, regardless of the programme delivery format or setting, all patients should be assessed by a trained healthcare professional prior to commencement, in order to: ensure that the person can safely participate in exercise-based cardiac rehabilitation; tailor an appropriate programme for the patient. In addition, professional support should be available to patients throughout both centre and home-based programmes and patients should be advised on how to access that support. Trade-off between net clinical effects and costs One relevant economic evaluation was identified and included in this review that compared home-based rehabilitation to hospital-based rehabilitation for people with heart failure. This was a 5 year follow-up comparative costing of patients who participated in a trial by Cowie et al. 2011 included in the clinical review. The study found home-based rehabilitation to be more costly compared to hospital-based rehabilitation. When discussing this paper, the committee considered that the estimated intervention cost of home-based rehabilitation would be lower in current practice. In the study, the cost of DVD production to deliver the home-based intervention was divided by the number of patients in the study arm (n=15) to give the average cost per patient. In practice with a much larger population size, the committee considered that home-based rehabilitation would be less costly than hospital-based rehabilitation as the fixed cost of producing a DVD would be divided over a greater number of patients, and the marginal cost of providing each additional DVD would be minimal. The estimated intervention cost of hospital-based rehabilitation is unlikely to differ in current practice. The committee also noted that the admission costs were higher in the home-based rehabilitation group in this study. However, the committee considered this to be highly uncertain due to the small sample size of the study, and therefore did not put much weight on this finding. Although there was no clinical evidence for hospitalisations, the committee considered that home-based rehabilitation would have similar hospitalisation rates as hospital-based rehabilitation, and therefore admission costs would not differ greatly between the 2 interventions. The committee were concerned with the small sample size of this study (n=30), that there was a large age difference of patients in each arm, and that no health outcomes were reported, and therefore this study was assessed as partially applicable with very serious limitations. Due to the limited quality of economic evidence, the committee considered the current cost of hospital-based rehabilitation. According to NHS reference costs the cost of Rehabilitation for Acute Myocardial Infarction or Other Cardiac Disorders (VC38Z) is 238. The committee also mentioned that these patients are likely to require transport, further increasing the cost of this intervention. The other interventions for home-based rehabilitation programmes identified in the clinical review consisted of outdoor walking and weekly telephone calls to healthcare staff. The committee considered that this would require limited NHS resource if such Chronic Heart Failure Rehabilitation in chronic heart failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 programmes were implemented. Overall, the committee did not consider that home-based rehabilitation would be more costly than hospital/community rehabilitation as health professionals are not required to visit patients in their homes, and in some instances could be less costly. The lack of uptake of rehabilitation since the previous guideline has meant that the cost savings previously predicted due to reductions in hospitalisations have not come to fruition. Although there is no clinical evidence for hospitalisations the committee considered that home-based rehabilitation would have the same effect in reducing hospitalisations as hospital or centre based rehabilitation. Therefore the cost savings of rehabilitation are more likely to be met if home based rehabilitation is made available to aid in increasing the uptake of rehabilitation. The committee mentioned that in some areas hospital/centre-based rehabilitation is not available due to the significant up-front cost required to initiate the service. The committee agreed that initiating home-based rehabilitation programmes is unlikely to incur as high a cost, particularly if existing cardiac rehabilitation programmes are already in place, and considered that this recommendation would aid in reducing barriers to access. Due to the considerations above, the committee decided that home-based rehabilitation should be available for heart failure patients to increase uptake of rehabilitation and facilitate the previously predicted cost-savings. Other considerations The committee noted that access to cardiac rehabilitation for heart failure patients is currently highly variable and uptake nationally remains low. The committee s recommendation should address some of the underlying issues by improving access, equity, participation and adherence. The CHF Quality standard (QS9 2016, statement number 7) identified the need for choice of venues and measures such as providing transport when offering rehabilitation programmes to ensure equality of access for all the heart failure population. This update has added to the 2010 recommendations on rehabilitation while recognising the importance of programmes including a psychological and educational component and that the programme may be incorporated within an existing cardiac rehabilitation programme. The committee also noted the recommendations in the Patient experience in adult NHS services guideline that advocates an individualised approach to healthcare services tailored to patient needs and circumstances. All patients in the trials had HF with reduced ejection fraction (HFREF). However, as the 2010 recommendation to offer cardiac rehabilitation applied to all patients with heart failure, the committee saw no reason to limit the updated recommendation following this evidence review. Chronic Heart Failure Monitoring NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 The update to the heart failure guideline includes topics where new evidence has emerged since the publication in 2010. A review of new evidence published after 2010 was carried out in order to determine whether any changes to current recommendations where likely to be required. The decision on which topics to include in the update of the guideline was made following consultation of the scope. 