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CARDIOVASCULAR ANESTHESIA

The Effect of Heart Rate Control on Myocardial Ischemia Among High-Risk Patients After Vascular Surgery

Khether E. Raby, MD, FACC^*, Sorin J. Brull, MD, Farris Timimi, MD, Shamsuddin Akhtar, MD, Stanley Rosenbaum, MD, Cameron Naimi, BS, and Anthony D. Whittemore, MD

*Department of Medicine, Boston University School of Medicine; Departments of Medicine and Surgery, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts; and Department of Anesthesia, Yale-New Haven Hospital, Yale University School of Medicine, New Haven, Connecticut

Address correspondence and reprint requests to Khether E. Raby, MD, Cardiac Catheterization Laboratory, Boston Medical Center, 88 East Newton St., Boston, MA, 02118. Address e-mail to Khether.Raby{at}BMC.ORG

	Abstract

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Patients undergoing vascular surgery have a high risk of suffering major postoperative cardiac events. Preoperative myocardial ischemia as detected by Holter monitoring identifies a high-risk subgroup whose postoperative ischemia, similarly detected, seems to herald major cardiac events. In this study, we determined whether systematic, patient-specific postoperative heart rate control with ß-adrenergic blocker therapy decreases the incidence of postoperative ischemia among high-risk vascular surgery patients. A total of 26 of 150 patients who underwent elective vascular surgery and were monitored preoperatively by 24-h Holter were found to have significant myocardial ischemia as defined by ST-segment depression. The minimal heart rate at which this ST-segment depression occurred was identified (ischemic threshold), and these 26 patients were then randomized to receive continuous IV ß-blockade with esmolol or placebo plus usual medical therapy, aiming to reduce the postoperative heart rate to 20% below the ischemic threshold. All patients were monitored by Holter for 48 h postoperatively. Postoperative Holter readings were analyzed for the incidence of ischemia and for the number of hours during which heart rate was controlled below the ischemia threshold. Patients had a median of two episodes of preoperative ischemia lasting a median of 30 min (range 1–155 min). A total of 15 patients were randomized to receive esmolol, and 11 were randomized to receive placebo. The two groups were comparable with respect to clinical characteristics and incidence and duration of preoperative ischemia. Ischemia persisted in the postoperative period in 8 of 11 placebo patients (73%), but only 5 of 15 esmolol patients (33%) (P < 0.05). Of the 15 esmolol patients, 9 had mean heart rates below the ischemic threshold, and all 9 had no postoperative ischemia. A total of 4 of 11 placebo patients had mean heart rates below the ischemic threshold, and 3 of the 4 had no postoperative ischemia. There were two postoperative cardiac events among patients who had postoperative ischemia (one placebo, one esmolol) and whose mean heart rates exceeded the ischemic threshold. Our data suggest that patient-specific, strict heart rate control aiming for a predefined target based on individual preoperative ischemic threshold was associated with a significant reduction and frequent elimination of postoperative myocardial ischemia among high-risk patients and provide a rationale for a larger trial to examine this strategy’s effect on cardiac risk.

Implications: Patients who undergo peripheral vascular surgery often experience transient cardiac complications and/or permanent heart damage just after surgery because of inadequate myocardial blood flow. In this study, we identified patients at high risk of cardiac complications after vascular surgery and showed that if their heart rate was carefully controlled for 48 h after surgery, myocardial ischemia, a common marker of heart injury, was markedly reduced.

	Introduction

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Patients undergoing peripheral vascular surgery have a 2%–16% risk of suffering a major postoperative cardiac event, including death, myocardial infarction, unstable angina, or pulmonary edema (1–5). Multiple studies have shown a high correlation of adverse cardiac events with the presence of perioperative myocardial ischemia (1–5). Moreover, adverse cardiac events, if nonfatal in the perioperative period, seem to predict especially poor outcome over long-term follow-up (6,7). One study demonstrated that 50% of patients who either had preoperative myocardial ischemia or had a perioperative ischemic event went on to cardiac death or myocardial infarct within 1 yr of follow-up (6). Consequently, there has been considerable interest in the identification and treatment of high-risk vascular surgery patients with an aim to reduce cardiac risk. Previous studies have found that the presence of preoperative asymptomatic myocardial ischemia, as defined by ST-segment depression detected on Holter monitoring, identifies a subgroup of high-risk patients (1,2). Further studies have shown that high-risk patients display a high frequency of tachycardia and asymptomatic ischemia in the first 48 postoperative hours, with ischemia almost uniformly preceding adverse cardiac events by a definable lag time (5,8). Postoperative ischemia seems to be the strongest predictor of postoperative adverse cardiac events, occurring most commonly within the first 48 h after vascular surgery (3,5,8). In one study, patients with postoperative ischemia were 34 times more likely to suffer perioperative cardiac events than patients without ischemia (8). The association of ischemia with tachycardia in the first 48 h after surgery has generated great interest in the use of ß-blocker therapy to limit perioperative myocardial ischemia (9–12). Mangano et al. (9) demonstrated that, in a group of patients undergoing noncardiac surgery, the use of ß-adrenergic blocker therapy substantially reduced perioperative and long-term risk of cardiac events compared with placebo. The same group demonstrated that ß-blockers were associated with significant decreases in perioperative ischemia compared with placebo (10).

Our objective was to determine whether postoperative ß-blocker therapy specifically tailored to control individual patient heart rate would result in a lower incidence of postoperative myocardial ischemia among high-risk vascular surgery patients.

	Methods

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Over a 2-yr period, 201 patients undergoing aortic aneurysm repair, infrainguinal arterial bypass, or carotid endarterectomy at Brigham and Women’s Hospital and Yale-New Haven Hospital were considered for enrollment. Patients who were receiving digitalis therapy, had baseline left bundle branch block or left ventricular hypertrophy, or had baseline ST-T changes that would preclude accurate interpretation of Holter monitor tapes for ischemia were excluded (n = 51). All other patients who gave their informed consent (n = 150) were screened with 24-h Holter monitor to detect myocardial ischemia 1–12 days before the scheduled surgery. Previous studies have suggested that, for this sample size, the characteristics of ischemia remain stable over this sampling period (1,13). Myocardial ischemia was defined as ST-segment depression that is horizontal and down-sloping, >1 mm from a predefined baseline, and lasting >1 min. Patients without preoperative myocardial ischemia as defined above were excluded from further study. Consenting patients with preoperative ischemia (n = 26) were enrolled in the study. For each enrolled patient, the minimal heart rate at which preoperative ischemia occurred (ischemic threshold) was identified. The target heart rate was then defined as a heart rate 20% below the ischemic threshold or an absolute minimum of 60 bpm. The choice of 20% and a minimum of 60 was believed to be a substantial heart rate reduction that was practically achievable within the short time period of the study. Holter monitoring was performed with digital monitors (Oxford, Clearwater, FL), and the full disclosure (all QRST complexes) was interpreted by a 24-h digital analyzer and by a technician blinded to patient characteristics and randomization. All episodes of ischemia were confirmed by an expert physician blinded to patient characteristics and randomization. Inter- and intraobserver variability was <2% for all episodes of ischemia detected.

Enrolled patients were then randomized to receive IV esmolol via a continuous infusion without a starting bolus, beginning at a dose of 100 µg · kg^-1 · min^-1 or isotonic sodium chloride solution IV (placebo) via a continuous infusion, beginning immediately after surgery and just before arrival in the postanesthesia care unit. In both randomization groups, the infusion was adjusted continuously every hour by the nurse for 48 h postoperatively to a maximal esmolol dose of 300 µg · kg^-1 · min^-, aiming to reduce postoperative heart rate to the identified target heart rate or less throughout this period. The maximal dose was chosen to minimize the incidence of side effects (wheezing, hypotension, bradycardia). The use of alternative ß-blocker therapy, calcium channel blocker therapy, nitrates, and various forms of analgesia was permitted per the judgment of the independent managing physicians in both groups, without a specific protocol. All patients in the study received aspirin preoperatively and for at least 48 h postoperatively. Patients and clinicians were blinded to the randomization throughout the study period, although physicians were permitted to monitor patient heart rates throughout the study.

All patients were monitored for 48 h postoperatively by Holter monitoring to maximize the yield of postoperative ischemia detection without prolonging hospital stays (8). In addition, all patients were kept in a monitored bed setting (intensive care unit or telemetry) for 48 h postoperatively. Cardiac events included cardiac death as defined by standard criteria (1–3); myocardial infarction, defined as any creatine kinase (CK) increase associated with a CK MB increase >5%; unstable angina (defined as chest symptoms diagnosed as angina at rest by an independent managing clinician and associated with 1 mm ST-segment depression in more than one lead or new T-wave inversions in more than one lead); or pulmonary edema (diagnosed by the independent managing clinician and by new heart failure identified by either a chest radiograph or pulmonary arterial pressure measurements). In addition, all postoperative Holter monitor tapes were analyzed for the number and duration of ischemic episodes for each patient, as well as the number of hours that the target heart rate was achieved in each patient from the total of 48 h monitored postoperatively.

Statistical analysis was performed as follows: clinical characteristics including gender, age, history of myocardial infarction or angina, diabetes, type of surgery, type of anesthesia, prevalence of preoperative ischemia, and other cardiac medications used were compared between the esmolol and placebo groups using a contingency table or nonparametric analysis. The number of episodes and total duration of postoperative ischemia were compared between the esmolol and placebo groups by using nonparametric analysis. A stepwise logistic regression analysis was used to control for gender, age, history of documented coronary artery disease, diabetes, type of surgery, type of anesthesia, ischemic threshold heart rate, target heart rate achievement (mean < ischemic threshold) during the postoperative period, and randomization to determine any independent predictors for the elimination of postoperative ischemia. All of these variables were included, and model fit was tested according to the Wald statistical criterion, using a threshold of = 0.20. This threshold has been recommended as suitable for detecting important confounders without including multiple unimportant nonconfounders that would widen confidence intervals without changing the point estimate of the effect (14,15).

	Results

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A total of 26 patients had preoperative myocardial ischemia identified by Holter monitoring. These patients had a median of two episodes of preoperative ischemia (one to seven episodes) lasting a median of 30 min (range 1–155 min). A total of 15 patients were randomized to esmolol, and 11 were randomized to placebo. Uneven randomization was the result of the randomization process only (coin flip). The two groups were comparable with respect to clinical characteristics, including mean blood pressures for the perioperative period, intensive care unit/telemetry stays, preoperative ischemia, and minimal heart rate at which preoperative ischemia occurred. The placebo group had significantly higher use of alternative ß-blocker therapy compared with the esmolol group (82% vs 13%; P < 0.05) (Table 1), which suggests that managing clinicians, who did not recognize any episodes of postoperative ischemia, recognized patients receiving active drug or placebo despite blinding. The placebo group did not have significantly higher use of calcium channel blockers, nitrates, or analgesic therapy. There was a statistically insignificant trend toward lower overall mean heart rates and lower mean heart rates when postoperative ischemia was eliminated in patients receiving esmolol (Table 2). Esmolol patients had fewer episodes and shorter duration of postoperative ischemia (Figure 1). Ischemia persisted in the postoperative period in 8 of 11 placebo patients (73%) but in only 5 of 15 esmolol patients (33%; p < 0.05) (Table 1, Figure 1). Among the 15 esmolol patients, 9 had mean heart rates below the ischemic threshold, and none of these 9 patients had any postoperative ischemia. Among placebo patients, 4 of 11 had mean heart rates below the ischemic threshold, and only 1 of these 4 patients had any postoperative ischemia (Figure 2).

View larger version (20K): [in this window] [in a new window]   Figure 1. Response of ischemia to esmolol and placebo.

View larger version (22K): [in this window] [in a new window]   Figure 2. Response of ischemia to heart rate control.

	Discussion

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The use of ß-blocker therapy has long been advocated in the control of ischemic heart disease. There are convincing data that ß-blockers are highly effective in controlling symptoms resulting from coronary artery disease, as well as in reducing the risk of ischemia among selected patients with coronary artery disease (11,16). Systematic use of ß-blocker therapy among high-risk patients undergoing noncardiac surgery has only recently been extensively studied. Nonrandomized trials among vascular surgery patients suggested that patients who receive ß-blocker therapy have a lower incidence of adverse cardiac events compared with patients who did not receive ß-blocker therapy (12,17). Moreover, catecholamine levels increase gradually in the first 48 h after surgery, simultaneous with the highest incidence of adverse cardiac events (18). Furthermore, multiple studies have shown that, among high-risk vascular surgery patients, the presence of postoperative ischemia detected by Holter monitoring was common and correlated strongly with adverse cardiac events (3,4,8). It has also been suggested that the prevalence of postoperative myocardial ischemia in the first 48 h after surgery is associated with a modest but discernible increase in heart rate compared with the preoperative period (4,5). Hence, the use of ß-blocker therapy in the postoperative period seems logical.

Mangano et al. (9) reported the randomization of 200 patients undergoing noncardiac surgery to atenolol versus placebo in the perioperative period, demonstrating a dramatic decrease in the incidence of adverse cardiac events. Interestingly, this group also noted a prolonged protective effect of ß-blockers against adverse cardiac events, postulating that the elimination of prolonged ischemia during the high-risk postoperative period had favorable long-term effects. Wallace et al. (10) demonstrated that randomization to perioperative atenolol was associated with reduced postoperative ischemia in the same patient population.

We demonstrated that strict heart rate control, when tailored to the individual’s baseline ischemic heart rate threshold as determined by preoperative monitoring, was associated with a reduction of postoperative ischemia during the highest risk period after vascular surgery. Moreover, it seems that the use of a specific ß-adrenergic blocker per se was less important to the elimination of postoperative myocardial ischemia than was strict heart rate control. Although the esmolol group experienced less postoperative ischemia, it was heart rate control that independently predicted ischemia elimination.

Despite randomization, effective investigator blinding, and every attempt to blind managing clinicians to postoperative ischemia activity, it was apparent to these clinicians from heart rate monitoring that placebo patients were not receiving ß-blocker therapy. This resulted in extensive alternative ß-blocker use in this group. Although the use of alternative beta blockers was less effective, likely because of slower response to heart rate increase than was achieved in the esmolol arm, patients in the placebo arm who achieved strict heart rate control had similar reduction of postoperative ischemia compared with esmolol patients. These observations suggest that optimal heart rate control, however achieved, was associated with ischemia reduction. Finally, two adverse events occurred with extensive ischemia among patients who were unable to achieve heart rate control in the postoperative period, which also suggests that heart rate control, more so than beta blocker therapy, was the key element in reducing postoperative ischemia and cardiac risk.

No patient in our study had ß-blocker therapy suspended because of unacceptable side effects. This is largely because the ß-blocker used was short-acting and titrated at relatively small doses for short periods of time, reducing the risk of unacceptable side effects, while adequately controlling heart rates in most patients. Although larger esmolol doses may have resulted in still better heart rate control and, hence, less postoperative ischemia, the cost would likely have been the incidence of side effects. The relative safety and efficacy of ß-blocker use in our study suggests that these drugs should be used more extensively among patients undergoing high-risk surgery, such as vascular surgery. Such a strategy may obviate the need for expensive and time-consuming screening preoperative strategies to risk-stratify patients (19,20).

The limitations of our study are that the sample size was small, the randomization arms were uneven, the surgical procedures and anesthesia techniques were varied, and alternative ß-blockers were extensively used in the placebo arm, making extensive control of potential confounders with univariate and multivariate modeling difficult. Nevertheless, our study is consistent with published data that suggest that perioperative ß-blockade reduces postoperative ischemia and long-term risk (9,10) and supports the American College of Physicians’ guidelines recommending more extensive use of ß-blockers in this setting (20). Our data also suggest that tailoring heart rate reduction to a patient-specific threshold may be useful in managing postoperative ischemia among high-risk patients and provide a rationale for more appropriately sized clinical trails that would examine the effect of this strategy on cardiac risk.

	Acknowledgments

 
Supported in part by a grant from Ohmeda, Inc.

	Footnotes

 
Presented in part at the Society of Cardiovascular Anesthesia meeting May 1997.

	References

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Anesthesia & Analgesia® is published for the International Anesthesia Research Society® by Lippincott Williams & Wilkins with the assistance of Stanford University Libraries' HighWire Press®. Copyright 2006 by the International Anesthesia Research Society. Online ISSN: 1526-7598   Print ISSN: 0003-2999