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Pre-op and Post-op Beta Blockers

Pre-op and Post-op Beta Blockers. Alla Kotlyanskaya, Pharm.D. Clinical Pharmacist – Critical Care Woodhull Medical Center, Brooklyn, New York Adjunct Professor of Pharmacology College of Nursing Graduate Programs SUNY Downstate College of Nursing And Adjunct Professor of Pharmacotherapy

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Pre-op and Post-op Beta Blockers

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  1. Pre-op and Post-op Beta Blockers Alla Kotlyanskaya, Pharm.D. Clinical Pharmacist – Critical Care Woodhull Medical Center, Brooklyn, New YorkAdjunct Professor of Pharmacology College of Nursing Graduate Programs SUNY Downstate College of Nursing And Adjunct Professor of Pharmacotherapy Physician Assistant Program

  2. Objectives • Discuss the protective effects of β-blockers in setting of perioperative beta blockade • Present standards of care for use of peri-operative β-blocker therapy • Describe the benefits & limitations of β-blockers in surgical population • Deliver final recommendations on when to use and why to avoid β-blockers in select patients

  3. Magnitude of Risks of Non-Cardiac Surgery • NON-cardiac surgery  risk of CARDIAC mortality • Adverse outcomes of post-op myocardial infarction (MI) •  LOS & healthcare costs • Results in 15 - 25% of all in-hospital mortality •  Cardiac death or non-fatal MI in next 6 months

  4. Why is Non-Cardiac Surgery Associated with Cardiac Complications • 100 million have non-cardiac surgery each year • Huge at-risk population • 1million suffer perioperative cardiac event • huge burden of disease • Frequently silent • Few interventions proven to lower risk

  5. Barriers Surrounding a Silent Myocardial Infarction Frequency of silent MI Chest pain (14%) Single symptom or sign (50%) Numerous explanations for under-diagnosis Opioids administration for surgical pain Residual effect of anesthesia Other reasons for BP, HR, SOB, N&V Different pathophysiology of perioperative MI?

  6. Pathophysiology TRIGGERS: surgery, anaesthesia, analgesia, intubation, extubation, pain, hypothermia, bleeding, anaemia, fasting Inflammation Hypercoagulability Stress state Hypoxic state Plaque Rupture Plaque Rupture • O2 demand O2 delivery Coronary thrombosis Myocardial ischemia PMI

  7. Initial Risk Assessment • In 1977 Goldman et al developed a preoperative cardiac risk index • 9 Individual risk factors and their scores • Risk Index: • Class I = 0-5 points (low) • Class II = 6-12 points (intermediate) • Class III = 13-25 pts (high) • Class IV  25 pts (very high)  N Engl J Med 1977;297:845-850

  8. Goldman Cardiac Risk Index Risk of Death and Major Cardiac Complications Based on the Goldman Index Class N Engl J Med 1977;297:845-850

  9. Cardiac Risk Stratification Proposals • Goldman: 1977 • Detsky: 1986 • Eagle: 1989 • Lee:1999

  10. ACC/AHA Guidelines Risk stratification according to major, intermediate or minor clinical predictors Am Coll Cardiol. 2007 Oct 23;50(17):e159-241.

  11. ACC/AHA Guideline Summary: Major Clinical Predictors High Risk: • Acute or recent MI (7-30 d) • Unstable coronary syndrome • Decompensated CHF • Significant Arrhythmias • Severe Valvular Disease Surgery Am Coll Cardiol. 2007 Oct 23;50(17):e159-241.

  12. ACC/AHA Guideline Summary: Clinical Risk Factors Proceed Cautiously With: • History of heart disease • Compensated or prior CHF • Cerebrovascular disease • Diabetes Mellitus • Renal Insufficiency 3 or more risk factors& Vascular surgery Consider testing Proceed with surgery or consider testing 1 – 2 risk factors Am Coll Cardiol. 2007 Oct 23;50(17):e159-241.

  13. ACC/AHA Guideline Summary: Minor Clinical Predictors Low Risk: • Low risk surgery • Good functional capacity • No cardiac symptoms • No “active cardiac conditions” • No clinical risk factors Reasonable to proceed with surgery Am Coll Cardiol. 2007 Oct 23;50(17):e159-241.

  14. Functional Capacity • Determined by how much physical activity a patient can tolerate without severe exertion • Provides valuable prognostic information • Patients with good functional status have a lower risk of complications

  15. Perioperative MI How to stratify it How to modify it ß Blocker Other New Agents

  16. The Evolution of ß-Blockers 1960s 1970s 1980s-1990s 2007 Non- Selective Non- Selective Non- Selective Non- Selective Selective Selective Vasodilating Vasodilating Vasodilating Atenolol Metroprolol Carvedilol Labetalol Nebivolol Propranolol

  17. Protective Effect of β-Blockers • Decrease sympathetic CNS outflow • ↓ Heart rate and ↓ contractility • ↓ Myocardial oxygen demand • Membrane stabilizing effect • Antiarrhythmic property • Anti-renin/antgiotensin properties • Inhibit renin release • Anti-inflammatory effect • Possible ↑ plaque stability* *With long-term use Schouten O et al. Cardiovascular Anesthesia 2007; 104(1):8-10. Cruickshank JM. European Heart Journal 2000; 21:354-364. Ohtsuka T et al. J Am Coll Cardiol 2001; 37(2):412-417.

  18. Protective Effect of b-blockers Against Cardiac Events During and After Surgery TRIGGERS: surgery, anaesthesia, analgesia, intubation, extubation, pain, hypothermia, bleeding, anaemia, fasting Inflammation Hypercoagulability Stress state Hypoxic state Plaque Rupture Plaque Rupture • O2 demand O2 delivery Coronary thrombosis Myocardial ischemia PMI

  19. Protective Effect of b-blockers Against Cardiac Events During and After Surgery TRIGGERS: surgery, anaesthesia, analgesia, intubation, extubation, pain, hypothermia, bleeding, anaemia, fasting Stress state  Catechols/cortisol Coronary artery shear stress • HR, BP, FFAs • O2 • demand Plaque Rupture Coronary thrombosis Myocardial ischemia PMI

  20. Reducing Myocardial Ischemia • Avoid tachycardia & hypertension • Avoid hypotension • Avoid pain • Avoid hypercoagulation • Avoid vasospasm • Avoid tissue injury

  21. Does Perioperative Beta Blockade Work? Perioperative β-Blockers 1995 to 2005 • Mangano et al. at 19961 • Atenolol study • Poldermans et al. at 19992 • DECREASE trial Perioperative β -blockers 2005–2008 • Yang et al. at 20064 • MaVS study • Juul et al. at 20065 • DiPoM trial

  22. Effect of Atenolol on Mortality andCardiovascular Morbidity AfterNoncardiac Surgery Mangano DT, Layug EL, Wallace A, et al. N Engl J Med. 1996; 335: 1713-1720

  23. Mangano Trial: Overview • Randomized, double-blind, placebo-controlled trial • 200 patients included VA (Veterans’ Admin) patients with >= 2 risk factors for CAD • Age >65 y/o • Total cholesterol >240 mg/dL • Hypertension • Diabetes mellitus • Current smoking • Surgeries were: • Major vascular (~40%) • “Intraabdominal” (~20%) • Neurosurgery, general, plastic surgery and head and neck surgery

  24. PO Atenolol 50 mg IV Atenolol 5 mg Surgery For the Duration of Hospitalization Before After Placebo Placebo Patients were followed over the subsequent two years Mangano Trial: Study Design N Engl J Med. 1996; 335: 1713-1720

  25. Mangano Trial: Postoperative Mortality Reduction Number of death during Follow up N Engl J Med. 1996; 335: 1713-1720

  26. The Effect of Bisoprolol on PerioperativeMortality and Myocardial Infarction in High-risk Patients Undergoing Vascular SurgeryDutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography Study Group Poldermans D, Boersma E, Bax JJ, et al. N Engl J Med 1999; 341:1789–1794

  27. The DECREASE Trial : Overview • European, multicentered, unblinded RCT • 112 high risk patients undergoing major vascular surgery were randomized to • Bisoprolol 5mg orally (min. of 7 days before surgery) (n = 59) • Standard care (n = 53) • The study was stopped early

  28. The DECREASE Trial:Postoperative Cardiac Events Poldermans et al. NEJM 1999;341:1789.

  29. “There are still very few RCTs … and they do not provide enough data from which to draw firm conclusions. Current studies, however, suggest that … b-blockers reduce perioperative ischaemia, and may reduce the risk of MI and death in high-risk patients” RECOMMENDATIONS Class I 1. Beta-blockers required in the recent past to control symptoms of angina or patients with symptomatic arrhythmias or hypertension 2. Beta-blockers: patients at high cardiac risk owing to the finding of ischemia on preoperative testing who are undergoing vascular surgery Eagle KA, et.al. ACC/AHA guideline update for perioperative cardiovascular evaluation for noncardiac surgery: executive summary. J Am Coll Cardiol. 2002;39:542–553

  30. 22 RCTs published between 1980 and 2004 Median sample size: 61patients (total = 2437) Variety of patients and surgeries Treatment duration: 1 dose  30 days Length of follow-up: PACU discharge  30 days Overall quality of trials was acceptable 4 trials inadequate blinding 2 trials stopped early 1 trial inadequate randomization concealment

  31. Devereaux et al.: Metaanalysis Results Relative risks for major perioperative cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal cardiac arrest)

  32. Devereaux et al.: Metaanalysis Results Relative risks for bradycardia needing treatment

  33. Devereaux et al.: Metaanalysis Conclusion • Growing evidence suggests BB may reduce the risk of major perioperative cardiovascular events • However, increases the risk of bradycardia and hypotension requiring treatment • Evidence indicates that more further studies are needed

  34. Perioperative β -blockers 2005 – 2007

  35. Does Perioperative Beta Blockade Increase Risk ? Perioperative -blockade (POBBLE) for patients undergoing infrarenal vascular surgery: Results of a randomized double-blind controlled trial. POBBLE Trial Investigators, London, United Kingdom Brady AR, et.al. J Vasc Surg 2005; 41:602–609

  36. Double-blind randomized placebo-controlled trial Included low risk patients Treatment Metoprolol 50 mg PO BID or placebo ( from admission until 7 days after surgery) Primary endpoint 30 day cumulative risk of cardiac death, non-fatal MI, unstable angina, VT or stroke Patient group (n = 103 [stopped early]) POBBLE Trial Overview Brady AR, et.al. J Vasc Surg 2005; 41:602–609

  37. POBBLE Trial Results and Conclusion OR (CV event or death) = 0.93 (95% CI: 0.53-1.64) This trial indicates that in lower-risk patients, perioperative β-blockade does not reduce cardiovascular mortality BUT may have adverse intraoperative effects Brady AR, et.al. J Vasc Surg 2005; 41:602–609

  38. RECOMMENDATIONS • Class I • Beta blockers should be continued in patients undergoing surgery who are previously receiving beta blockers to treat angina, symptomatic arrhythmias, hypertension, or other ACC/AHA class I guideline indications. (Level of Evidence: C) • Beta blockers should be given to patients undergoing vascular surgery who are at high cardiac risk owing to the finding of ischemia on preoperative testing. Fleisher LA, et al. ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: executive summary. Anesth Analg 2008;106:685–712.

  39. Perioperative Beta Blockade After Another heated debate about the pros and cons of using beta blockers perioperatively in noncardiac surgery

  40. RCT of metoprolol versus placebo (30 d) Non-cardiac surgery With or at risk of IHD Sample size 10,000 patients Primary outcome 30 day cumulative risk of cardiac death, nonfatal MI and non-fatal cardiac arrest Devereaux PJ,et al. Am J Heart 2006; 152: 223-30

  41. 8,351 Patients Recruited 406 3548 2005 1506 191 sites 23 countries 886

  42. Trial Flow Diagram 8351 randomized 4177 allocated to matching placebo 4174 allocated to metoprolol CR 12 lost to follow-up 8 lost to follow-up 99.8% complete 30 day follow-up and include in intention-to-treat analysis

  43. 82% of participants had atherosclerotic disease Risk Criteria

  44. Primary Outcome 68% of MIs were asymptomatic

  45. Secondary Outcomes 60 strokes reported 49 ischemic, 3 hemorrhagic and 8 uncertain Of non-fatal strokes 59 % patients in the metoprolol group required help to perform daily activities

  46. After the POISE Study For every 1,000 patients treated, metoprolol would prevent 15 MIs 7 cases of new onset AF 3 post-op CABGs …. And there would be 8 excess deaths 5 excess strokes 53 patients with significant hypotension No effect on total mortality

  47. After the POISE Study • Continue β-blockers in patients who are on them already • Start β -blockers perioperatively only in patients who need lifelong β-blocker therapy • Coronary ischemia who are undergoing vascular surgery • Starting β-blockers immediately before surgery may be harmful • Start β-blockers as early before surgery as possible • 7 - 30 days before procedure … Cont’d

  48. After the POISE Study • After surgery focus shifts to continuing β-blockers appropriately • Assess for infection, pain, hypovolemia, or bleeding • If discontinuing β-blockers • Titrate • Restart as soon as unstable issues are resolved … Cont’d

  49. Conclusion • The data suggests that Beta Blockers are beneficial in patients with major cardiac risk • Beta Blockers associated with severe bradycardia and hypotension leading to stroke and death • Patients with low cardiac risk may exhibit a higher risk/benefit ratio • Intermediate risk patient need to undergo for further work up

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