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From the Writing Committee Members; *Society for Vascular Medicine and Biology Official Representative; American Society of Nuclear Cardiology Official Representative; Heart Rhythm Society Official Representative; 
Society for Vascular Surgery Official Representative; ||American Society of Echocardiography Official Representative; ¶Society of Cardiovascular Anesthesiologists Official Representative; #Society for Cardiovascular Angiography and Interventions Official Representative.
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Abstract |
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 Top Abstract INTRODUCTIONPERIOPERATIVE MEDICAL THERAPYAPPENDIX A:APPENDIX B:REFERENCES |
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These guidelines attempt to define practices that meet the needs of most patients in most circumstances. These guideline recommendations reflect a consensus of expert opinion after a thorough review of the available, current scientific evidence and are intended to improve patient care. If these guidelines are used as the basis for regulatory/payer decisions, the ultimate goal is quality of care and serving the patient’s best interests. The ultimate judgment regarding care of a particular patient must be made by the healthcare provider and patient in light of all the circumstances presented by that patient.
Sidney C. Smith, Jr., MD, FACC, FAHA
Chair, ACC/AHA Task Force on Practice Guidelines
Elliot M. Antman, MD, FACC, FAHA
Immediate Past-Chair, ACC/AHA Task Force on Practice Guidelines
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INTRODUCTION |
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TopAbstractINTRODUCTIONPERIOPERATIVE MEDICAL THERAPYAPPENDIX A:APPENDIX B:REFERENCES |
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Please note that the full 2002 Guideline on Perioperative Cardiovascular Evaluation for Noncardiac Surgery is being updated and represents current ACC/AHA policy, with the exception of the text and tables in the perioperative ß-blocker therapy section. This focused update replaces the ß-blocker section in the 2002 Guideline and is considered current ACC/AHA policy until the update of the full guideline is published. Please note that Table 2 (Clinical Predictors of Increased Perioperative Cardiovascular Risk) is currently under review and may be modified as part of the update of the full guideline.
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Organization of Committee and Evidence Review
The Committee to Update the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery: Focused Update on Perioperative Beta-Blocker Therapy reviewed the literature relevant to perioperative cardiac evaluation since the last publication of these guidelines in 2002. Literature searches were conducted in PubMed/MEDLINE. Searches were limited to the English language, 2002 through 2006, and human subjects. In addition, related-article searches were conducted in MEDLINE to find further relevant articles. Finally, committee members recommended applicable articles outside the scope of the formal searches.
As a result of these searches, 23 published articles and one abstract were identified and reviewed by the committee for the expedited update of the beta-blocker section. Using evidence-based methodologies developed by the ACC/AHA Task Force on Practice Guidelines, the committee updated the guideline text and recommendations.
These classes summarize the recommendations for procedures or treatments as follows:
Class I:
Conditions for which there is evidence for and/or general agreement that the procedure or treatment is beneficial, useful, and effective.
Class II:
Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment.
Class IIa:
Weight of evidence/opinion is in favor of usefulness/efficacy.
Class IIb:
Usefulness/efficacy is less well established by evidence/opinion.
Class III:
Conditions for which there is evidence and/or general agreement that the procedure/treatment is not useful/effective, and in some cases may be harmful.
In addition, the weight of evidence in support of the recommendation is listed as follows:
Level of Evidence A:
Data derived from multiple, randomized, clinical trials.
Level of Evidence B:
Data derived from a single-randomized trial or nonrandomized studies.
Level of Evidence C:
Only consensus opinion of experts, case studies, or standard-of-care.
A recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in guidelines do not lend themselves to clinical trials. Although randomized trials are not available, there may be a very clear clinical consensus that a particular test or therapy is useful and effective. The schema for classification of recommendations and level of evidence is summarized in Figure 1, which also illustrates how the grading system provides an estimate of the size of the treatment effect and an estimate of the certainty of the treatment effect.
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The Committee consisted of acknowledged experts in general cardiology as well as persons with recognized expertise in more specialized areas including anesthesiology, cardiovascular surgery, echocardiography, electrophysiology, interventional cardiology, nuclear cardiology, vascular medicine, and vascular surgery; both academic and private sectors were represented. The following organizations assigned official representatives: the Society for Vascular Medicine and Biology, American Society of Nuclear Cardiology, Heart Rhythm Society, Society for Vascular Surgery, American Society of Echocardiography, Society of Cardiovascular Anesthesiologists, and the Society for Cardiovascular Angiography and Interventions.
This document was reviewed by two official reviewers nominated by the ACC; two official reviewers nominated by the AHA; one official reviewer from the ACC/AHA Task Force on Practice Guidelines as well as reviewers from the Society for Vascular Medicine and Biology, American Society of Nuclear Cardiology, Heart Rhythm Society, American Society of Echocardiography, Society of Cardiovascular Anesthesiologists, and the Society for Cardiovascular Angiography and Interventions; and 20 content reviewers, including members from American College of Cardiology Foundation (ACCF) Cardiac Catheterization Committee, ACCF Peripheral Vascular Disease Committee, ACCF Cardiovascular Clinical Imaging Committee, ACCF Echocardiography Committee, ACCF Clinical Electrophysiology Committee, AHA Council on Cardiopulmonary Perioperative and Critical Care Leadership Committee, AHA Council on Cardiovascular Surgery and Anesthesia Leadership Committee, and the AHA Council on Clinical Cardiology, Electrocardiography, and Arrhythmias Committee.
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PERIOPERATIVE MEDICAL THERAPY |
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TopAbstractINTRODUCTIONPERIOPERATIVE MEDICAL THERAPYAPPENDIX A:APPENDIX B:REFERENCES |
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Class I
Class IIa
Class IIb
Class III
Summary of Evidence
Despite several meta-analyses, some reaching conflicting conclusions, there are still very few randomized trials of medical therapy before noncardiac surgery to prevent perioperative cardiac complications. The studies that have been conducted in this area have largely focused on ß-blocker therapy; however, there remain many limitations to the available data. Few studies have compared different ß-blocker agents or characterized their dose effect in the perioperative setting. Even fewer have included a protocol for the titration of therapy to effect (e.g., target heart-rate), or examined regimens that include a preoperative trial of ß-blocker therapy. Studies to determine the ideal target population, ideal dose, and route are lacking. In addition, the practical limitations such as how, when, how long, and by whom perioperative ß-blocker therapy is ideally or practically implemented remain unaddressed. Randomized, controlled trials are still needed to explore the observation that there may be some harm associated with ß-blocker therapy in low-risk patients (3). Moreover, there is currently a lack of data regarding which ß blocker to use perioperatively. Some observational data suggest that perioperative death or myocardial infarction (MI) rates may differ when different ß blockers are given perioperatively (4). In summary, the best approach on how to medically protect patients from cardiovascular complications during noncardiac surgery is still unknown.
Limitations in the Perioperative Beta-Blocker Literature:
Although many of the randomized, controlled trials of ß-blocker therapy are small, the weight of evidence—especially in aggregate—suggests a benefit to perioperative ß blockade during noncardiac surgery, particularly in high-risk patients. Current studies suggest that ß blockers reduce perioperative ischemia and may reduce the risk of MI and death in high-risk patients. Available evidence suggests, but does not definitively prove that, when it is possible, ß blockers should be started several days or weeks before elective surgery, with the dose titrated to achieve a resting heart rate between 50 and 60 bpm, to assure that the patient is indeed receiving the benefit of ß blockade and should continue during the intraoperative and postoperative period to maintain a heart rate <80 bpm (5). Several prospective, randomized trials are either underway or soon to be presented. These will hopefully shed light on some of the questions regarding perioperative ß-blocker therapy. Per the ACC/AHA Task Force on Practice Guidelines methodology, unpublished data cannot be used to formulate guideline recommendations.
Two randomized trials examined the effect of perioperative ß blockers on cardiac events surrounding surgery. Poldermans et al. (5) examined the effect of bisoprolol on patients undergoing vascular surgery and in patients at high-risk for perioperative cardiac complications scheduled for vascular surgery. Of 846 patients with risk factors for cardiac disease, 173 patients were found to have new regional wall motion abnormalities (RWMA) on dobutamine stress echocardiogram (DSE). Of these patients, 61 were excluded from further study owing to large areas (greater than or equal to five segments) of RWMA on DSE or because they were already taking ß blockers. The remaining 112 high-risk patients were randomized to standard care or bisoprolol started at least 7 days preoperatively and titrated to maintain heart rate <60 bpm preoperatively and <80 bpm intraoperatively and postoperatively. The rates of cardiac death (3.4% vs 17%; P = 0.02) and nonfatal MI (0% vs 17%; P 
0.001) were lower for the bisoprolol versus placebo groups, respectively. Importantly, because of the unblinded design and inclusion of only high-risk patients in this study, the results cannot be generalized to all patients undergoing noncardiac surgery.
Boersma et al. (6) subsequently reanalyzed the total cohort of 1351 consecutive patients considered for enrollment in the aforementioned randomized trial of bisoprolol. Forty-five patients had perioperative cardiac death or nonfatal MI. A total of 83% of patients had fewer than three clinical risk factors. Among this subgroup, patients receiving ß blockers had a lower risk of cardiac complications (0.8% [2 of 263]) than those not receiving ß blockers (2.3% [20 of 855]). In patients with three or more risk factors (17%), those taking ß blockers who had a DSE demonstrating four or fewer segments of new wall-motion abnormalities had a significantly lower incidence of cardiac complications (2.3% [2 of 86]) compared with those not receiving ß-blocker therapy (9.9% [12 of 121]). However, among the small group of patients with more extensive ischemia on DSE (five or more segments), there was no difference in the incidence of cardiac events (4 of 11 for those taking ß blockers versus 5 of 15 for those not taking ß blockers). Therefore, ß-blocker therapy was beneficial in all but the subset of patients with more extensive ischemia. Nevertheless, one must be cautious about inferring a class effect from this observation about bisoprolol and treatment protocol.
The Multicenter Study of Perioperative Ischemia research group (7,8) reported on 200 patients undergoing general surgery randomized to a combination of IV and oral atenolol versus placebo for 7 days. Although they found no difference in perioperative MI or death, they reported significantly fewer episodes of ischemia by Holter monitoring (24% vs 39%; P = 0.03) in the atenolol versus placebo groups, respectively. They then followed these patients after discharge and documented fewer deaths in the atenolol group over the subsequent 6 mo (1% vs 10%; P < 0.001). It is not clear why such a brief course of therapy could exert such a delayed effect, and the study did not control for other medications given either before or after surgery. Angiotensin-converting enzyme inhibitor and ß-blocker use preoperatively differed significantly between the study groups.
Additional studies have examined the use of perioperative ß blockers, but are limited in power to detect cardiac events or are not randomized. Stone et al. (9) randomized a group of patients with mild hypertension who underwent predominantly (58%) vascular surgery to oral ß blockers 2 h before surgery or standard care. Control subjects had a higher frequency (28%) of ST segment depression (on intraoperative monitoring, as reported by the authors) than treated patients (2%). In a nonrandomized study, Pasternack et al. (10) gave oral metoprolol immediately before surgery, followed postoperatively by IV metoprolol during abdominal aortic aneurysm repair. Only 3% suffered an acute MI compared with 18% for matched controls. Pasternack et al. (11) subsequently reported fewer episodes of intraoperative ischemia in patients treated with oral metoprolol before peripheral vascular surgery compared with untreated patients. Yeager et al. (12) reported a case–control analysis of their experience with perioperative MI during vascular surgery, comparing 53 index cases of perioperative MI with 106 matched controls. They found a strong association of ß-blocker use with a decreased likelihood of MI (odds ratio = 0.43; P = 0.01). Raby et al. (13) demonstrated in 26 vascular surgery patients with documented preoperative ischemia and randomized to a protocol of heart rate suppression with IV esmolol compared to standard care that the esmolol group had fewer episodes of ischemia than controls (33% vs 73%; P = 0.055). Zaugg et al. (14) randomized elderly noncardiac surgery patients to preoperative and postoperative atenolol titrated to heart rate and intraoperative atenolol titrated to heart rate or no ß blockers, and detected no episodes of intraoperative myocardial ischemia, electrocardiographic changes consistent with MI, or death in any group. Three (of 19) patients in the no ß-blocker group developed significant elevations of cardiac troponin-I consistent with a perioperative MI compared with 0 (of 40) patients who received one of the atenolol groups. Brady et al. (15) randomized patients undergoing elective vascular surgery to either metoprolol 50 mg twice per day or placebo, from admission to hospital, until 7 days postoperatively. They found no difference in cardiovascular events, which included MI, unstable angina, ventricular tachycardia, and stroke. This trial may have been underpowered (n = 103) to identify a difference in outcomes, particularly hard outcomes of death and MI. Also, by trial design, therapy was initiated the day before vascular surgery, and it is quite possible that those randomized to metoprolol received incomplete ß blockade in the early perioperative period.
Perioperative ß-blocker therapy has been reviewed in several meta-analyses and in a very large cohort population study. Auerbach and Goldman (16) undertook a review of this topic in 2002. They reported on a MEDLINE search and literature review of only five studies. (All five studies are included in Table 3.) They calculated a number needed to treat, on the basis of these studies, of only 2.5–6.7 to see improvement in measures of myocardial ischemia, and only 3.2–8.3 in. studies reporting a significant impact of ß blockers on cardiac or all-cause mortality. They concluded that the literature supports a benefit of ß blockers on cardiac morbidity.
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In contrast, Devereaux et al. (19) published their opinion article on the clinical evidence regarding the use of ß-blocker therapy in patients undergoing noncardiac surgery for the purpose of preventing perioperative cardiac complications. They expressed the opinion that the literature supporting use of ß blockers during noncardiac surgery is modest at best, based on a few small, unblinded studies with a focused patient population. In a review of the literature in 2005, Devereaux et al. (20) discussed 22 studies randomizing 2437 patients undergoing noncardiac surgery to ß-blocker therapy or placebo. The POBBLE study was not included in this review (14). They found no statistically significant benefit on any of the individual outcomes and a "nominally" statistically significant benefit (relative risk of 0.44 with 95% confidence interval [CI] 0.20–0.97, 99% CI 0.16–1.24) for the composite outcome of cardiovascular mortality, nonfatal MI, and nonfatal cardiac arrest. The authors felt these data were inadequate to draw conclusions and that a larger, controlled study is indicated before conclusions can be made. This review, however, included a wide variety of studies, patient populations, and ß-blocker regimens. Many of the studies described only a single or double dose of ß blocker preoperatively or at induction of anesthesia. Much of the data, therefore, does not pertain to perioperative ß blockade for the purpose of cardiac risk reduction or focused on a low-risk population. Additionally, the largest studies included—that is, those reported by Miller et al. (21) and preliminary data from Yang et al., 22 which together account for almost as many subjects as all other studies combined—may not have been appropriate to include in this analysis. The first, by Miller et al.,21 was a study of a single IV dose of ß blocker for the purpose of blood pressure control during intubation, not reduction of perioperative events. It included follow-up only to the point of discharge from the recovery room. The second, that of Yang et al.,22 has yet to be published and, therefore, has not undergone formal peer review. The studies included in this review also vary widely in length of follow-up.
McGory et al. (23) performed a meta-analysis of six randomized trials of perioperative ß blockade and concluded that therapy was associated with significant reductions in perioperative myocardial ischemia (33%–15%), MI, cardiac mortality, and long-term cardiac mortality (12%–2%). These authors used the combined data to derive odds ratios and CIs for several outcomes. For perioperative overall mortality the odds ratio for ß-blocker therapy was 0.52 (95% CI 0.20–1.35), and for perioperative cardiac mortality the odds ratio was 0.25 (95% CI 0.07–0.87). Neither the POBBLE study nor the unpublished findings included in the Devereaux et al. (20) article were included, explaining the marked difference in findings from the other meta-analysis.
A cohort study by Lindenauer et al. (24) reviewed records from over 700,000 patients undergoing noncardiac surgery at 329 hospitals in the United States. Participant hospitals in this cohort study were members of a consortium database measuring quality and health care use. These authors evaluated all noncardiac surgical cases, and compared those who received ß blockers within the first 2 days of hospitalization with those who did not receive ß blockers during the first 2 hospital days. The authors used propensity score matching techniques in an attempt to reduce bias. These authors found that for a revised cardiac risk index score (25) of three or more (based on the presence of history of ischemic heart disease, cerebrovascular disease, renal insufficiency, diabetes mellitus, or a patient undergoing high-risk surgery), patients who received ß blockers were significantly less likely to die in hospital. This was not true for those with a revised risk index of 2, 1, or 0. Those with a risk index of 0 were more likely to die in hospital if given a ß blocker on Day 1 or Day 2 of hospitalization. This study is retrospective and not randomized and, therefore, is subject to potential bias. This is particularly true in terms of reporting bias, as the documentation was based entirely on administrative data sets, using arbitrary definitions of "on" or "off" perioperative ß blockers, based solely on hospital day of use. Nonetheless, there appears to be an association between improved outcomes and the use of ß blockers in clinically high-risk patients.
Finally, one recent observational cohort study examined the question of which ß blocker may be best for perioperative medical therapy. Redelmeier et al. (4) reviewed administrative data related to elective surgery in Ontario, Canada, and documented perioperative ß-blocker usage from April 1992 to April 2002 (10 yr). They limited their analysis to patients older than the age of 65 yr, who were receiving either atenolol or metoprolol before and after surgery and identified 37,151 subjects. A total of 1038 suffered either a perioperative MI or death, and the rate of MI or death was significantly lower among those patients receiving atenolol versus metoprolol (2.5% vs 3.2%, P < 0.001). This difference persisted even after adjusting for demographic, clinical, and surgical factors. The inclusion of other long-acting ß blockers in the analysis yielded an identical risk reduction. These data suggest that long-acting ß blockade (when therapy is initiated before surgery) may be superior to short-acting ß blockade. These observations await clinical trial evaluation.
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APPENDIX A: |
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TopAbstractINTRODUCTIONPERIOPERATIVE MEDICAL THERAPYAPPENDIX A:APPENDIX B:REFERENCES |
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APPENDIX B: |
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TopAbstractINTRODUCTIONPERIOPERATIVE MEDICAL THERAPYAPPENDIX A:APPENDIX B:REFERENCES |
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Footnotes |
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2Please see Table 2, (Clinical Predictors of Increased Perioperative Cardiovascular Risk), for an explanation of the clinical risk factors. High cardiac risk includes patients with major and intermediate clinical predictors. Care should be taken in applying recommendations on ß-blocker therapy to patients with decompensated heart failure, nonischemic cardiomyopathy, high-degree AV block, or severe valvular heart disease in the absence of coronary heart disease.
Accepted for publication July 27, 2006.
Task Force Members: Sidney C. Smith, Jr., MD, FACC, FAHA, Chair; Alice K. Jacobs, MD, FACC, FAHA, Vice-Chair; Cynthia D. Adams, MSN, APRN-BC, FAHA; Jeffrey L. Anderson, MD, FACC, FAHA; Elliott M. Antman, MD, FACC, FAHA, Immediate Past Chair; David P. Faxon, MD, FACC, FAHA, Former Task Force Member; Valentin Fuster, MD, PhD, FACC, FAHA, FESC, Former Task Force Member; Jonathan L. Halperin, MD, FACC, FAHA; Loren F. Hiratzka, MD, FACC, FAHA, Former Task Force Member; Sharon A. Hunt, MD, FACC, FAHA; Bruce W. Lytle, MD, FACC, FAHA; Rick Nishimura, MD, FACC, FAHA; Richard L. Page, MD, FACC, FAHA; Barbara Riegel, DNSc, RN, FAHA.
Developed in Collaboration with the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society for Vascular Medicine and Biology.
This document was approved by the American College of Cardiology Foundation Board of Trustees in March 2006 and by the American Heart Association Science Advisory and Coordinating Committee in February 2006.
When citing this document, the American College of Cardiology Foundation requests that the following citation format be used: Fleisher LA, Beckman JA, Brown KA, Calkins H, Chaikof E, Fleischmann KE, Freeman WK, Froehlich JB, Kasper EK, Kersten JR, Riegel B, Robb JF. ACC/AHA 2006 Guideline Update on Perioperative Cardiovascular Evaluation for Noncardiac Surgery: Focused Update on Perioperative Beta-Blocker Therapy. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2002 Guidelines on Perioperative CardiovascularEvaluation for Noncardiac Surgery). J Am Coll Cardiol 2006;47: 2343–55.
Address correspondence and reprint requests (single copies, reprint number 71-0362) to American College of Cardiology Foundation, Resource Center, 9111 Old Georgetown Road, Bethesda, MD 20814-1699. Tel. 1-800-253-4636. To purchase bulk reprints up to 999 copies, call 1-800-611-6083 (U.S. only) or fax 413-665-2671; for 1000 or more copies, call 214-706-1789 or fax 214-691-6342. Address e-mail to pubauth{at}heart.org. This document is available on the World Wide Web sites of the American College of Cardiology (www.acc.org) and the American Heart Association (www.my.americanheart.org).
Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American College of Cardiology Foundation. Please address requests to copyright_permissions{at}acc.org.
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REFERENCES |
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TopAbstractINTRODUCTIONPERIOPERATIVE MEDICAL THERAPYAPPENDIX A:APPENDIX B:REFERENCES |
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