Is There a Role for Cardiac Rehabilitation After Coronary Artery Bypass Grafting?
2016; Lippincott Williams & Wilkins; Volume: 133; Issue: 24 Linguagem: Inglês
10.1161/circulationaha.115.017800
ISSN1524-4539
Autores Tópico(s)Pain Management and Treatment
ResumoHomeCirculationVol. 133, No. 24Is There a Role for Cardiac Rehabilitation After Coronary Artery Bypass Grafting? Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyRedditDiggEmail Jump toFree AccessResearch ArticlePDF/EPUBIs There a Role for Cardiac Rehabilitation After Coronary Artery Bypass Grafting?There is No Role for Cardiac Rehabilitation After Coronary Artery Bypass Grafting Miguel MendesMD Miguel MendesMiguel Mendes From West Lisbon Hospital Center, Hospital de Santa Cruz, Portugal; and Nova Medical School/Faculdade de Ciências Médicas, Lisbon, Portugal. Originally published14 Jun 2016https://doi.org/10.1161/CIRCULATIONAHA.115.017800Circulation. 2016;133:2538–2543Coronary artery bypass graft (CABG) was introduced by René Favaloro in 19681 as the first technique for myocardial revascularization. Since then, some methodological changes have been made, such as off-pump surgery,2 hybrid revascularization (CABG and percutaneous coronary intervention),3,4 and minimally invasive direct coronary artery bypass, trying to make this procedure less aggressive or invasive, although the regular CABG performed nowadays usually still requires sternotomy and sometimes saphenectomy, because the saphenous veins are additional or alternative bypass conduits to the left and right mammary or radial arteries, the first choice because of longer patency.Response by Niebauer on p 2544CABG is reserved today for patients with more complex coronary anatomy, defined by a Syntax score superior to 22, and in the presence of comorbidities like diabetes mellitus and renal failure.5–8Even performed with the most modern modalities, CABG is still an important insult, associated with several potential acute-phase complications like stroke, transient neurocognitive impairment, dehiscence of sternotomy, mediastinitis, myocardial infarction, pericardial tamponade, pericarditis, hemo- or pneumothorax, pleural effusion, acute renal failure, lower limb edema, anemia, infection, and atrial fibrillation or flutter,9–11 being much more aggressive then percutaneous transluminal coronary angioplasty, the most frequently used myocardial revascularization technique.CABG usually demands an in-hospital stay close to a week and, after discharge, patients usually need a 2- to 6-week convalescence period, necessary to recover from the procedure and to normalize daily activities, including return to work if applicable. A significant proportion of patients need to overcome residual problems, like heart failure, anemia, atrial fibrillation, pulmonary abnormalities, and thoracotomy- and saphenectomy-related pain.Later in the follow-up, patients can experience recurrent angina or acute coronary syndrome (ACS) attributable to coronary artery disease progression on the native coronary circulation or to bypass failure, particularly in the case of the venous grafts, which are more prone to stenosis after a few years.Patient's after CABG are prescribed with a complex drug regime and recommended to adopt a healthy lifestyle, including smoking cessation, diet, moderate exercise, and psychological stress control. The adherence to these behaviors is usually voluntarily adopted early after CABG but becomes more difficult in the long term.12–14Cardiac Rehabilitation After CABGConsidering the patient's need to obtain a full and prompt physical recovery after surgery to allow a fast normalization of daily life activities (including return to work), linked with the need to adopt a healthy lifestyle and the specific pharmacological regime for a lifetime, cardiac rehabilitation (CR), recently defined by the British Association for Cardiovascular Prevention and Rehabilitation as, "…the coordinated sum of activities required to influence favorably the underlying cause of cardiovascular disease, as well as to provide the best possible physical, mental and social conditions, so that the patients may, by their own efforts, preserve or resume optimal functioning in their community and through improved health behavior, slow or reverse progression of disease,"15 seems to be the perfect recommendation for early post-CABG patients.16CR is a comprehensive program, integrating individualized and supervised exercise with education, both important for patients after CABG. It acts in 2 steps: (1) CR promotes a faster and better recovery from heart surgery in the first weeks after the procedure, which is particularly important for the typical CABG patient, an elderly individual with several comorbidities and limitations; (2) it provides healthy routines, tools, and the knowledge necessary to manage coronary artery disease to be successful in the long term.Moholdt and coworkers,17 as others have, comparing the effect of a moderate continuous (the classic form of exercise in CR) and aerobic interval training in CR, observed a peak Vo2 increase in both subsets at the end of the program. In terms of secondary prevention after ACS, it was proven in the Global Secondary Prevention Strategies to Limit Event Recurrence After Myocardial Infarction (GOSPEL) study18 that CR improved risk factor control and adherence to secondary prevention lifestyle measures. The Italian Survey on Cardiac Rehabilitation and Secondary Prevention After Cardiac Revascularization (ICAROS Survey), which enrolled only patients after myocardial revascularization, ≈70% after CABG, also demonstrated good adherence to the healthy lifestyle and to the medication regime at 1 year.12The American Association of Cardiovascular and Pulmonary Rehabilitation/American College of Cardiology Foundation/American Heart Association performance measures 2010 update,19 the European Society of Cardiology recommendations on cardiac rehabilitation,20 and the American Heart Association and the European Society of Cardiology myocardial revascularization guidelines21 produced specific recommendations on CR, afterward adopted by many national societies. The 2011 American College of Cardiology Foundation/ American Heart Association guidelines on CABG22 classified CR after CABG as class I (level of evidence A) recommendation. The authors of 2014 European Society of Cardiology Guidelines on Myocardial Revascularization,8 taking into consideration the available evidence, were more restrictive and classified the recommendation for CR after CABG as class II (level of evidence A; Table 1).Table 1. ACCF/AHA and ESC Guidelines: Citations to Support the Recommendation of CR After CABGI. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery. Circulation 2011;124:e652– e735. Engblom E, Korpilahti K, Hamalainen H, et al. Quality of life and return to work 5 years after coronary artery bypass surgery. Long-term results of cardiac rehabilitation. J Cardiopulm Rehabil. 1997;17:29–36. Milani RV, Lavie CJ. The effects of body composition changes to observed improvements in cardiopulmonary parameters after exercise training with cardiac rehabilitation. Chest 1998;113:599–601. Taylor RS, Brown A, Ebrahim S, et al. Exercise-based rehabilitation for patients with coronary heart disease: systematic review and meta-analysis of randomized controlled trials. Am J Med. 2004;116:682–692. Clark AM, Hartling L, Vandermeer B, et al. Meta-analysis: secondary prevention programs for patients with coronary artery disease. Ann Intern Med. 2005;143:659–672. Thomas RJ, King M, Lui K, et al. AACVPR/ACC/AHA 2007 performance measures on cardiac rehabilitation for referral to and delivery of cardiac rehabilitation/secondary prevention services. Circulation. 2007;116:1611–1642. Walther C, Mobius-Winkler S, Linke A, et al. Regular exercise training compared with percutaneous intervention leads to a reduction of inflammatory markers and cardiovascular events in patients with coronary artery disease. Eur J Cardiovasc Prev Rehabil. 2008;15:107–112.II. 2014 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2014;35:2541–2619 Perk J, De Backer G, Gohlke H, et al. European Guidelines on cardiovascular disease prevention in clinical practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. Eur Heart J. 2012;33:1635–1701. Taylor RS, Brown A, Ebrahim S, et al. Exercise-based rehabilitation for patients with coronary heart disease: systematic review and meta-analysis of randomized controlled trials. Am J Med. 2004;116:682–692. Taylor RS, Unal B, Critchley JA, et al. Mortality reductions in patients receiving exercise-based cardiac rehabilitation: how much can be attributed to cardiovascular risk factor improvements? Eur J Cardiovasc Prev Rehabil. 2006;13:369–374. Hammill BG, Curtis LH, Schulman KA, et al. Relationship between cardiac rehabilitation and long-term risks of death and myocardial infarction among elderly Medicare beneficiaries. Circulation. 2010;121:63–70. Clark AM, Hartling L, Vandermeer B, et al. Meta-analysis: secondary prevention programs for patients with coronary artery disease. Ann Intern Med. 2005;143:659–672. Heran BS, Chen JM, Ebrahim S, et al. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011(7):CD001800. Janssen V, De Gucht V, Dusseldorp E, et al. Lifestyle modification programmes for patients with coronary heart disease: a systematic review and meta-analysis of randomized controlled trials. Eur J Prev Cardiol. 2013;20:620–640.ACCF indicates American College of Cardiology Foundation; AHA, American Heart Association; CABG, coronary artery bypass graft; CR, cardiac rehabilitation; and ESC, European Society of Cardiology.How Strong Is the Scientific Evidence?When we look at the citations mentioned in the 2011 American College of Cardiology Foundation/American Heart Association guidelines on CABG22 and the 2014 European Society of Cardiology guidelines on Myocardial Revascularization,8 which classified the indication for CR after CABG, respectively, as class I (level of evidence A) and a class II (level of evidence A), only articles assessing surrogate end points (quality of life, body composition, return to work), mechanistic or nonspecific for CABG articles are found, together with others published >15 years ago.The rationale behind these recommendations was to consider that benefits found in other clinical subsets of coronary artery disease, like after ACS, could be automatically extrapolated for post-CABG, which is not necessarily true.Searching the medical literature for articles published after 2005 to assess the effect of CR on post-CABG, only 6 articles were found: 3 on post-CABG–only patients23–25 and 3 on mixed populations: CABG and percutaneous coronary intervention (1 article),26 ACS/percutaneous transluminal coronary angioplasty/CABG plus valve surgery (1 article),27and 1 article on CABG plus valve surgery.28Regarding specifically the trials on post-CABG–only article, 3 observational and nonrandomized articles are found (Table 2). Kutner and coworkers,23 in a study with 6125 patients undergoing dialysis, found a 35% all-cause mortality and 36% cardiac death risk reduction after CR, although only 10% of the population participated in the program. Pack et al,24 in another observational community-based trial involving 846 patients, found a 46% risk reduction in all-cause mortality after a median follow-up of 9 years. Lee and coworkers25 studied 3975 patients enrolled at phases I and II of a CR program, although only 379 (<10%) participated in phase II. After a median follow-up of 6 years, a 20% risk reduction was found for patients enrolled in phase I and a 40% risk reduction for the participants in phase II.Table 2. Summary of CR on Post-CABG–Only Trials Published From 2006 to August 2015First Author/ ReferenceType of StudyNo.Follow-Up (Median/Years)CR Mortality ReductionKutner23Dialysis patients submitted to CABG6215 dialysis pts submitted to CABG; only 10% received CR (10.4% of pts aged 65)<6.035% RR for all-cause mortality (HR, 0.65; 95% CI, 0.56–0.76; P<0.001)Not randomized36% RR for cardiac death (HR, 0.64; 95% CI, 0.51–0.81; P<0.001).Pack24Community-based8469.0±3.746% RR all-cause mortality (HR, 0.54; 95% CI, 0.40–0.74; P<0.001)Not randomized10 y ARR=12.7.Lee25Community cohortBoth phases, n=3975 patients6.0 (4.3–9.5)Phase I: 20% RR (HR, 0.80; 95% CI, 0.64–0.98; P=0.043)Not randomizedPhase I: 2419 (60.8%) in CR and 1556 non-CRPhase II: 40% RR (HR, 0.60; 95% CI, 0.40–0.90; P=0.012)Phase II: 379 patients in CR and 1429 in non-CRARR indicates adjusted relative risk; CABG, coronary artery bypass graft; CI, confidence interval; CR, cardiac rehabilitation; HR, hazard ratio; pts, patients; and RR, relative risk.Considering now the trials after 2006 in which CABG patients were assessed together with patients from other subsets (Table 3), Hansen et al26 studied the effect of a 3-month CR program in 194 patients undergoing percutaneous coronary intervention and 149 CABG patients in comparison with 245 patients undergoing percutaneous coronary intervention and 89 CABG patients under usual care. They found 86% risk reduction on total cardiovascular disease, which was more pronounced in CABG patients.Table 3. Summary of CR on Post-CABG Plus Valve Surgery or in Mixed Populations (PTCA/CABG)First Author/ ReferenceSubsetType of StudyNo.Follow-Up, yCR Mortality ReductionHansen26PTCA and CABGNot randomized194 PCI and 149 CABG pts 3-mo CR program in comparison with 245 PCI and 89 CABG pts on standard care2.0Both CABG and PCI pts enrolled in CR showed 86% RR (0.6% vs 4.2%, P<0.05).Total cardiovascular disease incidence was significantly lower in CR-CABG patients (4.7% vs 14.0%, P<0.05), but not in PCI pts.Goel27CABG + valve surgeryConsecutive patients who underwent valve plus CABG201 pts; 125 aortic-only; 65 mitral-only; 3 tricuspide-only; 8 double-prosthesis6.8 (median)52%;Not randomizedARR over 10 y=14.5%;de Vries28ACS, PTCA, CABG + valve surgeryPopulation-based: 2007–201011 014 (30.7% of a 35 919 population) received CR2.1 (median)35% (adjusted HR, 0.65; 95% CI, 0.56–0.77).Nederlands(0.5–4.8)45% for CABG and valve surgery (HR, 0.55; 95% CI, 0.42–0.74).Not randomizedACS indicates acute coronary syndrome; ARR, adjusted relative risk; CABG, coronary artery bypass graft; CI, confidence interval; CR, cardiac rehabilitation; HR, hazard ratio; PCI, percutaneous coronary intervention; PTCA, percutaneous transluminal coronary angioplasty; and pts, patients.Goel and coworkers27 also studied the impact of CR on mortality in a population of 201 patients undergoing CABG combined with heart valve surgery, and they found a 52% mortality reduction (hazard ratio, 0.48; P=0.009) over a 6.8-year follow-up in a population of 201 patients submitted to CABG and different types of valve surgery. The subgroups analysis did not show different results considering age, sex, emergency status, heart failure, or arrhythmias.Finally, de Vries and coworkers28evaluated the effect on survival of a 3-month multidisciplinary CR program in a large population of patients from 2007 to 2010 after ACS or heart surgery (coronary revascularization alone or in combination with heart valve surgery). The study population, included 11 014 patients, only from The Netherlands (30.7% of the full population), admitted to a 3-month CR program, a subgroup of a larger population of 35 919 patients. They found a survival increase of 35% (hazard ratio, 0.65; 95% confidence interval, 0.56–0.77) for the group participating in CR, with the largest benefit found in patients who underwent CABG and valve surgery considered together (hazard ratio, 0.55; 95% confidence interval, 0.42–0.74). Unfortunately, the authors did not show the specific benefits for CABG-only patients; these patients were always considered as part of a group, where CABG and valve surgery were evaluated together, making it impossible to assess the benefits of the CABG-only group.Taylor and Anderson,29 very recently in an editorial in Heart, wrote that overviews, although providing a single synthesis of all the relevant evidence in a particular area and being useful for clinical and policy decision making, also have some limitations, such as being inappropriate to use in making indirect comparisons either across systematic reviews of interventions or populations. They also identified problems related with the quality of the primary trials, like lack of consistency in terms of use of outcome data by the trials and the fact that the randomized trials integrated in the analysis came from a very wide period of time (1974–2013), in which clinical practice changed because of the introduction of new therapies (drugs and techniques).DiscussionSearching into the medical literature for the scientific evidences of CR, in general, considering all the clinical subsets put together, there is good evidence of benefits in terms of all-cause or cardiovascular mortality30 and several soft end points like increase of exercise capacity,31 health-related quality of life, risk factor control, adherence to the pharmacological regime, adoption of a healthy lifestyle, and return to work.18Post-CABG is a clinical subset with specific problems to be managed in 2 phases: the acute (in-hospital and convalescence) and the maintenance phases. In the acute phase, the clinical targets are to relieve patients' concerns and limitations related to surgery, which may last for 2 to 6 weeks. In the maintenance phase, the focus should be on promoting the adoption of the healthy lifestyle recommended as secondary prevention in the guidelines, to be followed for life. A comprehensive CR program, capable of intervening positively in both phases, apparently has all the ingredients to be very successful.Considering the present scientific evidence published for CR in early CABG-only patients, it is not strong enough to produce the high strength level and specific recommendations found today on the most representative international guidelines.To the best of my knowledge, there is not 1 multicenter, randomized, controlled trial, or any other type of research with a large population, that specifically addresses the impact of CR in the setting of CABG-only patients. CABG-only patients have been frequently enrolled in larger trials on CR, as in several meta-analyses undertaken to study large mixed populations, assessing together post-ACS, percutaneous transluminal coronary angioplasty, CABG, and sometimes valve surgery alone or associated with CABG, but never CABG-only patients isolated.It may seem logical to consider that the positive effects demonstrated in the literature in post-ACS patients could also be found in post-CABG patients, because the training and maintenance phases are identical in both programs, but the CABG patients usually have more disabilities, are older, and have an increased prevalence of heart failure and other comorbidities, associated with higher rates of morbidity and mortality. The potential benefits brought to CABG patients by the participation in a 2- to 6-week convalescence period, although important to promote a prompt recovery from the aggressive surgery, probably will not have a measurable impact in the long term because of its short duration.Regarding the maintenance phase, the focus must be on secondary prevention, but to the best of my knowledge, there are no published articles studying the effects of CR on the nonnatural coronary circulation created by CABG, in particular, when the saphenous veins are used.As stated earlier, the trials studying post-CABG patients provide weak scientific evidence because they were not randomized and came from a single center or country, the study populations are relatively small, and the CABG patients included were a minority in the potential candidates, allowing suspicion of the presence of sample bias.Some nonrandomized trials found larger benefits when CABG was assessed together with valve surgery in comparison with the larger ACS population, but no individualized results of CABG-only patients can be found.Trying to minimize the methodological problems of these nonrandomized trials, the authors used sophisticated statistical methods like propensity score matching analysis. They claim that these observational studies have higher external validity and are more representative, because their population is larger and closer to a real-world population. Although the propensity score matching analysis aims to minimize the lack of randomization, it is impossible to guarantee that there is not a population bias, a healthy cohort bias, because the healthiest population members may have accepted to join the program that was rejected by the sicker members.In contrast, the randomized, controlled trials have a higher internal validity, because randomization overcomes confounding factors, although the study population may not be a real-world one and frequently underrepresents some groups like older people, women, and ethnic, socioeconomic, and other groups. The evidence coming from observational studies does not seem strong enough, and the CABG-only patients would win if an unequivocal and specific benefit for this clinical subsetting could be demonstrated.Knowing that, in the present times of economic containment, it is difficult to promote a randomized, controlled trial to address the question of the potential benefits of CR on post-CABG–only patients and that new formats of research are emerging, like registries and networks, I believe that, in this moment and time, a specific form of research is most needed to clarify this question.32ConclusionReviewing the scientific evidence today is not possible to sustain that CR as no role after CABG, because some benefits on surrogate end points, like on health-related quality of Life and return to work, have been clearly demonstrated. But, today's evidence does not allow us to state that CR after CABG clearly shows a decrease in all-cause or cardiovascular mortality, although it may seem apparently logical.In this moment and time, the evidence supporting CR in the US and European guideline recommendations for post-CABG is mainly based on the extrapolation for CABG patients of the evidence from CR programs after ACS. A class I recommendation for CR after CABG may seem logical, but it has not been specifically studied or really proven (yet?) by at least one unquestionable research. In medical science, we have often found that apparently logical recommendations are not confirmed later.From my point of view, considering the scientific evidence available until now (October 2015), it is impossible to sustain in this moment and time that CR can be recommended as a class I indication for CABG-only patients because of the lack of specific evidence.Some years ago, Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)33 (funded by the National Heart, Lung, and Blood Institute) was launched to clarify the role of exercise training in patients with heart failure. Now, it seems to be the perfect time to challenge the CR community with new research, testing the possibility that a modern comprehensive CR program (including the newest training modalities, education, and psychological support) in CABG-only patients, could provide unequivocal benefits in terms of hard (all-cause and cardiac mortality) and soft end points (exercise tolerance, risk factor control, health-related quality of life, and return to work) after a generous follow-up period (3–5 years).DisclosuresNone.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.This article is Part II of a 2-part article. Part I appears on p 2529.Correspondence to Miguel Mendes, MD, FACC, Cardiology Department, West Lisboa Hospital Center, Hospital de Santa Cruz, Av. Prof. Reynaldo dos Santos, 2790-134 Carnaxide, Portugal. E-mail [email protected]References1. 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Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial.JAMA. 2009; 301:1439–1450. doi: 10.1001/jama.2009.454.CrossrefMedlineGoogle ScholarResponse to MendesJosef Niebauer, MD, PhD, MBADr Mendes has to be congratulated for his well-balanced summary of today's role of cardiac rehabilitation in patients after coronary artery bypass grafting. In fact, I could not agree more with Dr Mendes' assessment that patients benefit from cardiac rehabilitation by improving, among others, their endothelial function, coronary blood flow, myocardial perfusion, disease progression, ischemia and its symptoms, quality of life, adherence to prescribed medication, adoption of a healthy lifestyle, lower risk of rehospitalization, lower morbidity and mortality, and earlier return to work. Indeed, it is not only the 2 of us who agree but also the authors of all major professional cardiac societies who, as a consequence of the abundance of unequivocal and undisputed literature, recommend wide use of cardiac rehabilitation. Of course, we also agree that a prospective, randomized, multicenter mortality trial would be great to have. However, despite the lack of such a study, it is not warranted to withhold a potent therapeutic option from patients that in professional hands has no serious side effects but exerts overwhelming benefit. Awaiting confirmatory studies would mean to unnecessarily and unjustifiably harm our patients. In fact, it is long due to do the obvious and enable patients in need to receive a therapeutic option that supplements all other evidence-based treatments for the above-mentioned reasons. Furthermore, I would like to call for an even wider implementation and use of cardiac rehabilitation not only in patients after coronary artery bypass grafting but whenever literature is unambiguously in support of it. Previous Back to top Next FiguresReferencesRelatedDetails June 14, 2016Vol 133, Issue 24Article InformationMetrics Download: 4,347 © 2016 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.115.017800PMID: 27297346 Originally publishedJune 14, 2016 PDF download SubjectsRevascularizationCardiovascular SurgeryCoronary Artery DiseaseSecondary PreventionRehabilitation
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