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Abstract |
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Perioperative myocardial ischemia (MI) is associated with postoperative cardiac morbidity. Postoperative sympatholysis may reduce the incidence of MI. This study evaluated such a reduction postoperatively with the administration of prophylactic ß-blockers in patients undergoing elective total knee arthroplasty with epidural anesthesia and postoperative epidural analgesia. One hundred seven patients were preoperatively randomized into two groups, control and ß-blockers, who received postoperative esmolol infusions on the day of surgery and metoprolol for the next 48 h to maintain a heart rate less than 80 bpm. Patients were followed for ST segment depression by using a Holter monitor and adverse cardiac outcomes. Postoperative electrocardiographic ischemia was significantly more prevalent in the control group compared with the ß-blocker group during esmolol blockade (0 of 52 vs 4 of 55; P = 0.04) and tended to be more common in the control group the next two days (8 of 55 vs 3 of 52; P = 0.135). In addition, the number of ischemic events (control, 50; ß-blockers, 16) and total ischemic time (control, 709 min; ß-blocker, 236 min) were also significantly different from the control group. Myocardial infarctions and cardiac events were more common in the control group, but these differences were not significant. Our results suggest that the use of prophylactic ß-blocker therapy may reduce the incidence of postoperative MI.
Implications: Prophylactic ß adrenergic blockade administered after elective total knee arthroplasty was associated with a reduced prevalence and duration of postoperative myocardial ischemia detected with Holter monitoring.
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Introduction |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Perioperative myocardial ischemia (MI) in patients with coronary artery disease (CAD) or risk factors for CAD is common (1–3). MI at each of the three perioperative stages, pre-, intra-, and postoperative, is associated with cardiac morbidity and mortality (4–6). However, postoperative ischemia has demonstrated the most consistent correlation with adverse cardiac outcomes (5). In addition, much of the ischemia during the pre- and intraoperative periods has been described as being hemodynamically silent and not associated with significant changes from baseline heart rate (HR) or blood pressure (BP) (3,7,8). Postoperative ischemia is often associated with hemodynamic changes, particularly elevated HRs, suggesting that ß-blocker therapy might be beneficial for the reduction of ischemia during the postoperative period (1,9). We tested this hypothesis in patients at risk of MI undergoing total knee arthroplasty.
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Methods |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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After institutional review board approval, 120 successive patients (60 control; 60 ß-blocker), aged 50 to 80 yr, scheduled for elective total knee arthroplasty with probable ischemic heart disease (IHD) were preoperatively randomized to receive postoperative ß-blocker treatment. All patients were assigned to one of the two authors (MKU or MG) for the administration of anesthesia. Patients were considered to have IHD and included in the study if they had documented CAD or risk factors for CAD per Mangano et al. (5). Patients were considered to have documented CAD if they had cardiac angiographic evidence of significant coronary stenosis, a positive exercise stress test, a thallium imaging study suggestive of CAD or a previous myocardial infarction. Patients with symptoms of IHD (chest pain, exertional dyspnea) but without documentation required an additional risk factor (hypertension, diabetes) to qualify for entrance in the study. Patients with electrocardiographic (ECG) evidence of left ventricular hypertrophy with repolarization abnormalities, complete bundle branch block, and atrial arrhythmias were excluded from the study. In addition, patients with significant left ventricular dysfunction (left ventricular ejection fraction <30%), symptomatic mitral or aortic valvular disease, or bronchospastic disease were also excluded.
One hundred nine patients were enrolled on the day of surgery. After entry in the study, a Marquette Series 800 Holter Monitor (Marquette Electronics, Jupiter, FL) with seven electrodes was placed on the patient in a modified V5, V1, V3 configuration at least 30 min before entry into the operating room. All patients were monitored intraoperatively with standard monitors, including an indwelling arterial catheter and, in selected patients (55%), a pulmonary artery catheter.
All patients received an epidural anesthetic of 0.75% bupivacaine (12–15 mL) and were sedated with IV midazolam and fentanyl. None of the patients received ß-blockers pre- or intraoperatively. There were no epidural anesthetic failures, and none of the patients required positive pressure ventilation. The epidural catheter was used postoperatively for pain control with an infusion of 5 µg/mL fentanyl/0.125% bupivacaine for the first 24 h and fentanyl alone for the next 24 to 72 h. In addition, all patients were monitored in an intensive care unit setting for the first postoperative 12 to 24 h.
Patients in the control group were treated for hemodynamic alterations at the discretion of the ICU attending physicians or their internist. Patients in the ß-blocker group received an esmolol infusion (250 mg/h) within 1 h after surgery, which was continued until the following morning and titrated to maintain the HR below 80 bpm. On the morning of the first postoperative day, ß-blocker patients were switched to oral metoprolol at a starting dose of 25 mg twice per day, which was increased to maintain the HR below 80 bpm and continued for the next 48 h. All patients were taking metoprolol at a minimum of 50 mg twice per day by the end of the study period, which was continued until discharge from the hospital.
The physicians providing anesthesia were unaware of which group the patients were enrolled. In addition, the physicians providing postoperative care in the ICU were cognizant of which patients were receiving esmolol infusions, but were instructed to provide the same level of medical care and pain control to all patients and were blinded to the results of the Holter monitor tapes.
The Marquette Holter monitor tapes were analyzed for myocardial ischemia based on the criteria of horizontal or downsloping ST segment depression of 
1 mm below the baseline, lasting for at least 1 min. Events were separated by at least 5 min without ECG ischemia. Investigators analyzing the Holter tapes and performing the outcome analysis were blinded to the groups. Patients were considered to have sustained a myocardial infarction if they exhibited both ECG changes and a serum creatine phosphokinase isoenzyme MB frac- tion isoenzyme index 3.0 (total serum creatine phosphokinase-MB isoenzyme concentration divided by the total serum creatine phosphokinase concentration x 100). ECG changes included new ST-T changes, T inversions, Q waves, and/or a bundle branch block.
For the analysis of nominal values, a contingency coefficient was derived and from that an odds ratio determined to assess the relative risk of these variables for the development of myocardial infarction, (MI), or cardiac morbidity. When appropriate, significance was determined by using 
2 with a continuity correction, P 
0.05. A power analysis for myocardial morbidity as an outcome, assuming an incidence of 15% with ß-blocker therapy resulting in a 50% reduction at a power of 80% and significance 0.05, indicated that 240 patients were required in each group.
The study was concluded when the acute pain service team changed the formulation of the postoperative patient-controlled analgesia (PCA) epidural infusion.
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Results |
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One hundred nine patients were initially enrolled in the study; 107 patients completed the study with readable Holter monitor tapes (55 control, 52 ß-blocker; Fig. 1), and data are presented according to intention to treat. Both groups were similar with regard to age, comorbidities, and physical status (Table 1), and of the preoperative comorbidities analyzed, only a history of congestive heart failure was a significant risk factor for postoperative myocardial morbidity, odds ratio 2.33. A history of a previous MI was more common in the control group, but was not a significant difference from the ß-blocker group or an independent risk factor for postoperative MI or a postoperative myocardial infarction.
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The overall incidence of ECG ischemia was 2.8% (3 of 107) preoperatively, 7.5% (8 of 107) intraoperatively, and 10.2% (11 of 107) postoperatively. Pre- and intraoperative ischemia was not significantly different between the two groups; five patients in the control and six patients in the ß-blocker group. In the control group, three of the patients who were ischemic intraoperatively remained ischemic postoperatively whereas only one (1 of 6) of the patients in the ß-blocker group also demonstrated postoperative ECG ischemia.
Postoperatively, ECG ischemia tended to be more common in patients in the control group (8 of 55), than in patients in the ß-blocker group (3 of 52; P = 0.135; Table 2). During the esmolol infusion stage (18–24 h postoperatively), 4 patients in the control group demonstrated ECG ischemia (4 of 55) compared with no patients in the ß-blocker group (0 of 52) (P = 0.04). The number of ischemic events (50 vs 16) and total ischemic time (709 vs 236 min) were also significantly more common in the control group (range, 4–14 events/patient) versus the ß-blocker group (range, 1–9 events/patient; P < 0.05) (Fig. 2). Three patients in the control group had ischemic episodes lasting more than 30 min, and all of the patients had postoperative MIs. None of the three ß-blocker patients, who exhibited postoperative ECG ischemia had episodes lasting more than 20 min. The mean HR for all patients in the ß-blocker group for the entire study period was 79 bpm, whereas at the onset of ischemia, the mean HR was 86 bpm. All of the postoperative ischemic patients in the ß-blocker group and 6 of 8 of the control patients had HR greater than 80 bpm.
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There were more MIs and cardiac morbidity in the control group compared with the ß-blocker group, but these differences were not statistically significant (Table 3). The patient in the ß-blocker group who sustained a postoperative MI completed the protocol and did not demonstrate Holter monitor ECG ischemia for the first 48 postoperative h. The MI, which occurred on postoperative Day 2 (after the Holter was removed), was accompanied by angina and an elevated HR (90–100 bpm) despite continued ß-blocker therapy. An ECG recording, at the time, revealed the loss of T waves laterally.
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Intention to treat analysis results in a conservative impression of the effects of ß-blockade in this population. Several of the patients in each group received treatment outside of the study protocol. Of the 52 patients in the ß-blocker group, only 41 received esmolol on the day of surgery. Ten patients were not started on esmolol because their HRs remained below 60 bpm, and 1 patient was started on esmolol but the infusion was stopped within an hour because of a sudden decrease in HR and BP. Only 2 patients were not started on ß-blockers on the morning of the first postoperative day because of persistent bradycardia. Of the control patients, 6 were treated with ß-blockers on the day of surgery to control tachycardia and hypertension. Three of these patients exhibited ischemia with elevated HRs, which resolved after ß-blockade. One of these patients required an esmolol infusion to control persistent tachycardia with ECG-ischemia. An additional 12 control patients were treated with ß-blockers during postoperative Days 1 and 2 for elevated HR and BP. Hence, 3 of 50 ß-blocker patients who completed the protocol and 8 of 43 control patients were not treated with ß-blockers until an event demonstrated ECG ischemia (P = 0.06).
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Several studies have demonstrated an association between perioperative MI and cardiac morbidity and mortality (4–6). Preoperative ischemia may be a predictor of postoperative cardiac morbidity and indicate a need for preoperative treatment modifications (4,10,11). The association of intraoperative ischemia and adverse cardiac events has never been completely established, but the incidence may have been reduced with improved anesthetic techniques (1). Several studies have shown that postoperative ischemia is strongly associated with both short- and long-term cardiac morbidity (5,12,13). Postoperative stress (pain, blood loss, fluid shifts), manifested as hemodynamic lability, is prevalent after surgery and may be responsible for this increased incidence of myocardial ischemia (12,14,15). In patients with significant CAD an elevated HR may lead to an imbalance between myocardial oxygen supply and demand, leading to cardiac ischemia and morbidity. Hence, postoperative ß-blockade may attenuate this stress response and reduce the incidence of myocardial ischemia.
The results of this study suggest that patients at risk of MI have fewer ischemic episodes postoperatively, which are of shorter duration when prophylactically treated with ß-blockers. Indeed, during the period of intensive hemodynamic control with IV ß-blockade, there were no instances of MI. The reduced incidence of MI in ß-blocked patients may be related to the prevention of elevated HRs, because only those patients with HRs above the target rate of 80 bpm had ischemic episodes.
There have been a few published reports demonstrating the benefit of perioperative sympatholysis in reducing MI (16–18). These studies were performed in patients undergoing various types of noncardiac surgery, including vascular surgery, under general anesthesia. Our study is unique in that all of the patients underwent an identical surgical procedure, total knee arthroplasty, using the same anesthetic, epidural bupivacaine. Hence, the reduction in ischemia in the ß-blocker group cannot be attributed to major differences in anesthetic management.
The two groups were also similar in other respects. Patients were included in the study only if they had objective evidence of or significant risk factors for CAD. None of the patients had unstable angina. All of the patients received the same postoperative pain therapy, epidural PCA with bupivacaine and fentanyl. The demographic profile of the two groups was similar. Chronic cardiac medications were similar in both groups: 14 ß-blocker and 16 control patients were receiving ß-blockers; 17 ß-blocker and 14 control patients were receiving calcium channel blockers; and 4 ß-blocker and 6 control patients were receiving digoxin. We were unable to demonstrate an association between the type of preoperative medications and postoperative ECG-ischemia or cardiac morbidity.
The incidence of postoperative ischemia in our study was lower (approximately 10%) than previously published (16%–30%) for patients with IHD undergoing noncardiac surgery (2,5,15,19). The difference is not related to entry demographics, because patients with the same cardiac risks were included in all the studies. Most of the previously published reports included vascular procedures, which may induce more perioperative stress than orthopedic procedures. Compared with previously published reports, all of our patients had regional anesthesia and their postoperative pain was controlled with epidural PCA. Regional anesthesia and analgesia has been shown to both improve and not change the incidence of cardiac morbidity for vascular surgery (20–22). However, even in the report of Christopherson et al. (21) in which a difference between regional and general anesthesia for cardiac outcomes could not be established, patients in the general/IV analgesia group required more hemodynamically stabilizing interventions. Postoperative analgesia with local anesthetics may provide improved amelioration of the stress response (23). Furthermore, all of the patients in this study were monitored in an ICU setting for at least 12 hours postoperatively and their hemodynamic status aggressively managed.
It is difficult to demonstrate outcome benefits for any intervention when the incidence of morbidity is low. This was true for this study, although the patients were preselected to be at higher risk for an adverse cardiac outcome. In this study, only 4% of the patients had postoperative MIs and there were no cardiac deaths. Hence, although adverse cardiac outcomes were more common in the control group, we were unable to demonstrate a significant advantage for ß-blocker treatment in the reduction of cardiac morbidity. A power analysis indicated that 240 patients were required in each group with this incidence of cardiac morbidity to demonstrate a significant difference in cardiac outcome. Our initial study design had predicted a greater incidence of adverse cardiac effects in this "higher" risk population. Furthermore, on completion of 120 surgeries, several variables had changed at our institution, including the epidural PCA mixture and postoperative use of ß-blockers.
Mangano et al. (16) were able to demonstrate an advantage to perioperative ß-blocker therapy in a two-year postoperative follow up, but the postoperative in-hospital cardiac mortality was also too low to show an advantage (one patient in the atenolol group and two patients in the control group). The European McSPI group (17) reported a reduced incidence of ischemia in patients treated preoperatively with mivazerol, and 
2 adrenergic agonist, but again the number of patients suffering adverse cardiac outcomes was too small to show a difference between groups.
The reduction in the incidence of ST segment depression as an outcome goal for therapeutic intervention is still controversial (24). Fleischer (24) argues correctly that ST segment changes in low-risk populations are most likely false positives. However, we preselected this patient population to be at a moderate to high risk of MI. Furthermore, the three control patients with postoperative MIs had ECG ischemic episodes detected by Holter monitoring at the time of the MI. He further argues that suppression of ECG ischemia does not obligate a reduction in myocardial morbidity. We are unable to defend this point, except to note that there was a trend toward a reduction in adverse cardiac events in the ß-blocker group.
The study was designed to permit the physicians responsible for the care of these patients postoperatively to institute or withhold care based on the clinical situation. Because these patients were believed to be in a higher cardiac risk group, we chose not to constrain those physicians entrusted with their care from intervening when they felt it was appropriate. Hence one third of the patients in the control group were treated with ß-blockers postoperatively to maintain HR and BP at baseline levels. During the first 18 hours postoperatively, six control patients were treated with ß-blockers, and three of these patients demonstrated evidence of MI. Very aggressive patient management may have ameliorated the differences in cardiac morbidity between the two groups. Nevertheless, even with these limitations, we were able to demonstrate an advantage in the use of prophylactic ß-blocker administration to reduce postoperative MI, as assessed by using ECG ST segment depression. In conclusion, aggressive perioperative management of orthopedic patients with cardiac risk factors results in a low incidence of postoperative cardiac events that may be further reduced with the addition of prophylactic ß-blockade.
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References |
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- Mangano DT. Perioperative cardiac morbidity. Anesthesiology 1990;72:153–84.[Web of Science][Medline]
- Roy WL, Edelist G, Gilbert B. Myocardial ischemia during noncardiac surgical procedures in patients with coronary artery disease. Anesthesiology 1979;51:393–7.[Web of Science][Medline]
- Haggmark S, Hohner P, Ostman M, et al. Comparison of hemodynamic, electrocardiographic, mechanical and metabolic indicators of intraoperative myocardial ischemia in vascular surgical patients with coronary artery disease. Anesthesiology 1989;70:19–25.[Web of Science][Medline]
- Raby KE, Goldman L, Creager MA, et al. Correlation between preoperative ischemia and major cardiac events after peripheral vascular surgery. N Engl J Med 1989;321:1296–300.[Abstract]
- Mangano DT, Browncer WS, Hollengerg M, et al. Association of perioperative myocardial ischemia with cardiac morbidity and mortality in men undergoing noncardiac surgery. N Engl J Med 1990;323:1781–8.[Abstract]
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Raby KE, Barry J, Creager MA, et al. Detection and significance of intraoperative and postoperative myocardial ischemia in peripheral vascular surgery. JAMA 1992;268:222–7.
[Abstract/Free Full Text] - London MJ, Hollenberg M, Wong MG, et al. Intraoperative myocardial ischemia: localization by continuous 12-lead electrocardiography. Anesthesiology 1988;69:232–41.[Web of Science][Medline]
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Urban MK, Gordon MA, Harris SN, et al. Intraoperative hemodynamic changes are not good indicators of myocardial ischemia. Anesth Analg 1993;76:942–9.
[Abstract/Free Full Text] - Hollenberg M, Mangano DT. Therapeutic approaches to postoperative ischemia. Am J Cardiol 1994;73:30–3.
- Eagle KA, Coley CM, Newell JB, et al. Combining clinical and thallium data optimizes preoperative assessment of cardiac risk before major vascular surgery. Ann Intern Med 1989;110:859–66.
- Huber KC, Evans MA, Bresnahan JF, et al. Outcome of noncardiac operations in patients with severe coronary artery disease successfully treated preoperatively with coronary angioplasty. Mayo Clin Proc 1992;67:15–21.[Web of Science][Medline]
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Mangano DT, Browner WS, Hollenberg M, et al. Long-term cardiac prognosis following noncardiac surgery. JAMA 1992;268:233–9.
[Abstract/Free Full Text] - Landesberg G, Luria MH, Cotev S, et al. Importance of long-duration postoperative ST-segment depression in cardiac morbidity after vascular surgery. Lancet 1993;341:715–9.[Web of Science][Medline]
- Mangano DT, Wong MG, London MJ, et al. Perioperative myocardial ischemia in patients undergoing noncardiac surgery. II. Incidence and severity during the 1st week after surgery. J Am Coll Cardiol 1991;17:851–7.[Abstract]
- Marsch SC, Schaefer HG, Skarvan K, et al. Perioperative myocardial ischemia in patients undergoing elective hip arthroplasty during lumbar regional anesthesia. Anesthesiology 1992;76:518–27.[Web of Science][Medline]
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Mangano DT, Layug EL, Wallace A, Tateo I. Effect of atenolol on mortality and cardiovascular morbidity after noncardiac surgery. New Engl J Med 1996;335:1713–63.
[Abstract/Free Full Text] - McSPI Europe Research Group.Perioperative sympatholysis. Anesthesiology 1997;86:346–63.[Web of Science][Medline]
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Ellis JE, Drijvers G, Pedlow S, et al. Premedication with oral and transdermal clonidine provides safe and efficacious postoperative sympatholysis. Anesth Analg 1994;79:1133–40.
[Abstract/Free Full Text] - Ebert TJ, Kharasch ED, Rooke GA, et al. Myocardial ischemia and adverse cardiac outcomes in cardiac patients undergoing noncardiac surgery with sevoflurane and isoflurane. Anesth Analg 1997;85:993–9.[Abstract]
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Tuman KJ, McCarthy RJ, March RJ, et al. Effects of epidural anesthesia and analgesia on coagulation and outcome after major vascular surgery. Anesth Analg 1991;73:696–704.
[Abstract/Free Full Text] - Christopherson R, Beattie C, Frank SM, et al. Perioperative morbidity in patients randomized to epidural or general anesthesia for lower extremity vascular surgery. Anesthesiology 1993;79:422–34.[Web of Science][Medline]
- Bode RH, Lewis KP, Zarich SW, et al. Cardiac outcomes after peripheral vascular surgery. Anesthesiology 1996;84:3–13.[Web of Science][Medline]
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M. Zaugg, C. Schulz, J. Wacker, and M. C. Schaub Sympatho-modulatory therapies in perioperative medicine Br. J. Anaesth., July 1, 2004; 93(1): 53 - 62. [Abstract] [Full Text] [PDF]
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 P. K. Lindenauer, J. Fitzgerald, N. Hoople, and E. M. Benjamin The Potential Preventability of Postoperative Myocardial Infarction: Underuse of Perioperative {beta}-Adrenergic Blockade Arch Intern Med, April 12, 2004; 164(7): 762 - 766. [Abstract] [Full Text] [PDF]
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M. D. Kertai, E. Boersma, J. J. Bax, I. R. Thomson, M. J. Cramer, L. L. M. van de Ven, M. G. Scheffer, G. Trocino, C. Vigna, H. F. Baars, et al. Optimizing Long-term Cardiac Management After Major Vascular Surgery: Role of {beta}-Blocker Therapy, Clinical Characteristics, and Dobutamine Stress Echocardiography to Optimize Long-term Cardiac Management After Major Vascular Surgery Arch Intern Med, October 13, 2003; 163(18): 2230 - 2235. [Abstract] [Full Text] [PDF]
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R. D. Stevens, H. Burri, and M. R. Tramer Pharmacologic Myocardial Protection in Patients Undergoing Noncardiac Surgery: A Quantitative Systematic Review Anesth. Analg., September 1, 2003; 97(3): 623 - 633. [Abstract] [Full Text] [PDF]
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M. Licker, G. Khatchatourian, A. Schweizer, M. Bednarkiewicz, D. Tassaux, and C. Chevalley The Impact of a Cardioprotective Protocol on the Incidence of Cardiac Complications After Aortic Abdominal Surgery Anesth. Analg., December 1, 2002; 95(6): 1525 - 1533. [Abstract] [Full Text] [PDF]
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 A. D. Auerbach and L. Goldman {beta}-Blockers and Reduction of Cardiac Events in Noncardiac Surgery: Scientific Review JAMA, March 20, 2002; 287(11): 1435 - 1444. [Abstract] [Full Text] [PDF]
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A. D. Auerbach and L. Goldman {beta}-Blockers and Reduction of Cardiac Events in Noncardiac Surgery: Clinical Applications JAMA, March 20, 2002; 287(11): 1445 - 1447. [Abstract] [Full Text] [PDF]
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M. Zaugg, M. C. Schaub, T. Pasch, and D. R. Spahn Modulation of {beta}-adrenergic receptor subtype activities in perioperative medicine: mechanisms and sites of action Br. J. Anaesth., January 1, 2002; 88(1): 101 - 123. [Abstract] [Full Text] [PDF]
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 D. A. Zvara Treatment of Perioperative Myocardial Ischemia Seminars in Cardiothoracic and Vascular Anesthesia, July 1, 2001; 5(2): 166 - 183. [Abstract] [PDF]
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 C. H. Selzman, S. A. Miller, M. A. Zimmerman, and A. H. Harken The Case for {beta}-Adrenergic Blockade as Prophylaxis Against Perioperative Cardiovascular Morbidity and Mortality Arch Surg, March 1, 2001; 136(3): 286 - 290. [Abstract] [Full Text] [PDF]
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S. J. Howell, J. W. Sear, and P. Foex Editorial I: Peri-operative {beta}-blockade: a useful treatment that should be greeted with cautious enthusiasm Br. J. Anaesth., January 1, 2001; 86(2): 161 - 164. [Full Text] [PDF]
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