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HFSA 2010 Comprehensive Heart Failure Practice Guideline

HFSA 2010 Comprehensive Heart Failure Practice Guideline. Key Recommendations. “Is recommended” “Should be considered” “May be considered” “Is not recommended”. Part of routine care Exceptions should be minimized Majority of patients should receive intervention Some discretion allowed

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HFSA 2010 Comprehensive Heart Failure Practice Guideline

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  1. HFSA 2010 Comprehensive Heart Failure Practice Guideline Key Recommendations

  2. “Is recommended” “Should be considered” “May be considered” “Is not recommended” Part of routine care Exceptions should be minimized Majority of patients should receive intervention Some discretion allowed Individualization of therapy is indicated Therapy should not be used HFSA 2010 Comprehensive Heart Failure Practice GuidelineStrength of Recommendation

  3. A B C Randomized controlled trials May be assigned on results of 1 trial Cohort and case control studies Includes sub group analyses, meta-analyses, observational studies, registries Expert opinion Includes observational, epidemiological findings; in-practice safety reporting HFSA 2010 Comprehensive Heart Failure Practice GuidelineStrength of Evidence

  4. HFSA 2010 Practice Guideline (3.1)Heart Failure Prevention Adapted from:

  5. HFSA 2010 Practice Guideline (3.2)HF Risk Factor Treatment Goals Adapted from:

  6. Aggressive blood pressure control: Aggressive BP control in patients with prior MI: Treating Hypertension to Prevent HF Decreases risk of new HF by ~ 50% 56% in DM2 Decreases risk of new HF by ~ 80% Lancet 1991;338:1281-5 (STOP-Hypertension JAMA 1997;278:212-6 (SHEP) UKPDS Group. UKPDS 38. BMJ 1998;317:703-713

  7. HFSA 2010 Practice Guideline (3.3-3.4)Prevention—ACEI and Beta Blockers • ACE inhibitors are recommended for prevention of HF in patients at high risk for this syndrome, including those with: • Coronary artery disease • Peripheral vascular disease • Stroke • Diabetes and another major risk factorStrength of Evidence = A • ACE inhibitors and beta blockers are recommended for all patients with prior MI.Strength of Evidence = A

  8. Management of Patients with Known Atherosclerotic Disease But No HF • Treatment with ACE inhibitors decreases the risk of CV death, MI, stroke, or cardiac arrest. NEJM 2000;342:145-53 (HOPE) Lancet 2003;362:782-8 (EUROPA) Placebo HOPE Ramipril 22% rel. risk red. p < .001 EUROPA Placebo Perindopril 20% rel. risk red. p = .0003

  9. Treatment of Post-MI Patients with Asymptomatic LV Dysfunction (LVEF ≤ 40%) • SAVE Study • All-cause mortality ↓19% • CV mortality ↓21% • HF development ↓37% • Recurrent MI ↓25% Mortality Rate Placebo Captopril 19% rel. risk reduction p = 0.019 Years Pfeffer et al. NEJM 1992;327:669-77

  10. The Additional Value of Beta Blockers Post-MI: CAPRICORN • Studied impact of beta blocker (carvedilol) on post-MI patients with LVEF ≤ 40% already receiving contemporary treatments, including revascularization, anticoagulants, ASA, and ACEI: • All-cause mortality reduced (HR = 0.077; p = 0.03) • Cardiovascular mortality reduced (HR = 0.75; p = .024) • Recurrent non-fatal MIs reduced (HR =.59; p = .014) Dargie HJ. Lancet 2001;357:1385-90

  11. HFSA 2010 Practice Guideline (4.8, 4.10)Heart Failure Patient Evaluation • Recommended evaluation for patients with a diagnosis of HF: • Assess clinical severity and functional limitation by history, physical examination, and determination of functional class* • Assess cardiac structure and function • Determine the etiology of HF • Evaluate for coronary disease and myocardial ischemia • Evaluate the risk of life threatening arrhythmia • Identify any exacerbating factors for HF • Identify co-morbidities which influence therapy • Identify barriers to adherence and complianceStrength of Evidence = C *Metrics to consider include the 6-minute walk test and NYHA functional class Adapted from:

  12. HFSA 2010 Practice Guideline (4.19)Evaluation—Follow Up Assessments • Recommended Components of Follow-Up Visits • Signs and symptoms evaluated during initial visit • Functional capacity and activity level • Changes in body weight • Patient understanding of and compliance with dietary sodium restriction and medical regimen • History of arrhythmia, syncope, pre-syncope, palpitation, or ICD discharge • Adherence and response to therapeutic interventions • Exacerbating factors for HF, including worsening ischemic heart disease, hypertension, and new or worsening valvular disease Strength of Evidence = B

  13. HFSA 2010 Practice Guideline (7.1, 7.7)Pharmacologic Therapy: ACE Inhibitors • ACE inhibitors are recommended for symptomatic and asymptomatic patients with an LVEF ≤ 40%. Strength of Evidence = A • ACE inhibitors should be titrated to doses used in clinical trials (as tolerated during uptitration of other medications, such as beta blockers). Strength of Evidence = C • ACE inhibitors are recommended as routine therapy for asymptomatic patients with an LVEF ≤ 40%. • Post MIStrength of Evidence = B • Non Post-MIStrength of Evidence = C Adapted from:

  14. SOLVD Prevention (Asymptomatic LVD) 20% death or HF hosp. 29% death or new HF CONSENSUS (Severe Heart Failure) 40% mortality at 6 mos. 31% mortality at 1 year 27% mortality at end of study No difference in incidence of sudden cardiac death ACE Inhibitors in Heart Failure:From Asymptomatic LVD to Severe HF SOLVD Treatment (Chronic Heart Failure) mortality 16% SOLVD Investigators. N Engl J Med 1992;327:685-91 SOLVD Investigators. N Engl J Med 1991;325:293-302 CONSENSUS Study Trial Group. N Engl J Med 1987;316:1429-35

  15. ACE Inhibitors Used in Clinical Trials *No mortality difference between high and low dose groups, but 12% lower risk of death or hospitalization in high dose group vs. low dose group.

  16. HFSA 2010 Practice Guideline (7.2)Pharmacologic Therapy:Substitutes for ACEI • It is recommended that other therapy be substituted for ACE inhibitors in the following circumstances: • In patients who cannot tolerate ACE inhibitors due to cough, ARBs are recommended.Strength of Evidence= A • The combination of hydralazine and an oral nitrate may be considered in such patients not tolerating ARBs.Strength of Evidence = C • Patients intolerant to ACE inhibitors from hyperkalemia or renal insufficiency are likely to experience the same side effects with ARBs. In these cases, the combination of hydralazine and an oral nitrate should be considered.Strength of Evidence = C

  17. HFSA 2010 Practice Guideline (7.6, 7.7)Pharmacologic Therapy: Beta Blockers • Beta blockers shown to be effective in clinical trials are recommended for symptomatic and asymptomatic patients with an LVEF ≤ 40%. • Strength of Evidence = A • Beta blockers are recommended as routine therapy for asymptomatic patients with an LVEF ≤ 40%. • Post MIStrength of Evidence = B • Non Post-MIStrength of Evidence = C

  18. Effect of Beta Blockade on Outcome in Patients With HF and Post-MI LVD 1Colucci WS et al. Circulation 1196;94:2800-6. 2CIBIS II Investigators. Lancet 1999;353:9-13. 3MERIT-HF Study Group. Lancet 1999;353:2001-7. 4Packer M et al. N Engl J Med 2001;344 1651-8. 5The CAPRICORN Investigators. Lancet 2001;357:1385-90.

  19. HFSA 2010 Practice Guideline (7.8)Pharmacologic Therapy: Beta Blockers • RECENT DECOMPENSATION • Beta blocker therapy is recommended for patients with a recent decompensation of HF after optimization of volume status and successful discontinuation of IV diuretics and vasoactive agents. • Whenever possible, beta blocker therapy should be initiated in the hospital at a low dose prior to discharge of stable patients.Strength of Evidence = B Adapted from:

  20. HFSA 2010 Practice Guideline (7.11)Pharmacologic Therapy: Beta Blockers • SYMPTOMATIC EXACERBATION • Continuation of beta blocker therapy is recommended in most patients experiencing a symptomatic exacerbation of HF during chronic maintenance treatment, unless they develop cardiogenic shock, refractory volume overload, or symptomatic bradycardia.Strength of Evidence = C • Temporary dose reduction may be considered • Avoid abrupt discontinuation • Reinstate or gradually increase prior to discharge • Titrate dose to previously tolerated dose as soon as possible Adapted from:

  21. COPERNICUS: Death, Hospitalization, or Study Drug Withdrawal in High Risk Patients 30 HR = 0.67 (CI = 0.47-0.96) 20 Placebo % of Patients With Event 10 Carvedilol 0 0 2 4 6 8 Weeks After Randomization Krum H et al. JAMA 2003;289:754-6 Krum et al. JAMA 2003;289

  22. IMPACT-HF Primary End Point:Patients Receiving Beta Blocker at 60 Days Improvement 18% CarvedilolPredischarge Initiation (n=185) Physician Discretion Postdischarge Initiation* (n=178) Gattis WA et al. JACC 2004;43:1534-41

  23. HFSA 2010 Practice Guideline (7.9)Pharmacologic Therapy: Beta Blockers • CONCOMITANT DISEASE • Beta blocker therapy is recommended in the great majority of patients with HF and reduced LVEF—even if there is concomitant diabetes, chronic obstructive lung disease or peripheral vascular disease. • Usewith caution in patients with: • Diabetes with recurrent hypoglycemia • Asthma or resting limb ischemia. • Use with considerable caution in patients with marked bradycardia (<55 bpm) or marked hypotension (SBP < 80 mmHg). • Not recommended in patients with asthma with active bronchospasm. Strength of Evidence = C

  24. 0.5 1.5 2.0 0 1.0 Diabetes and the Use of Beta Blockers for HF: Relative Risk for Mortality and Hospitalization for Heart Failure COPERNICUS (carvedilol)1 With diabetes Without diabetes MERIT-HF (ER metoprolol succinate)2 With diabetes Without diabetes Mohacsi. Circulation. 2001;104(17):abstr 3551. Hjalmarson. JAMA. 2000;283(10):1295.

  25. HFSA 2010 Practice Guideline (11.8, 15.2)Pharmacologic Therapy: Beta Blockers • PRESERVED LVEF • Beta blocker treatment is recommended in patients with HF and preserved LVEF who have: • Prior MIStrength of Evidence = A • Hypertension Strength of Evidence = B • Atrial fib. requiring control of ventricular rateStrength of Evidence = B • THE ELDERLY • Beta-blocker and ACE inhibitor therapy is recommended as standard therapy in all elderly patients with HF due to LV systolic dysfunction.Strength of Evidence = B • In the absence of contraindications, these therapies are also recommended in the very elderly (age > 80 years). Strength of Evidence = C

  26. HFSA 2010 Practice GuidelinePharmacologic Therapy: Beta Blocker Overview* *Consult language of specific recommendations Adapted from:

  27. Beta Blockers Used in Clinical Trials

  28. HFSA 2010 Practice Guideline (7.3)Pharmacologic Therapy: Angiotensin Receptor Blockers • ARBs are recommended for routine administration to symptomatic and asymptomatic patients with an LVEF ≤ 40% who are intolerant to ACE inhibitors for reasons other than hyperkalemia or renal insufficiency. • Strength of Evidence = A

  29. Val-HeFT ARBS in Patients Not Taking ACE Inhibitors: Val-HeFT & CHARM-Alternative CHARM-Alternative Placebo Valsartan Survival % CV Death or HF Hosp % Placebo Candesartan p = 0.017 HR 0.77, p = 0.0004 Months Months Maggioni AP et al. JACC 2002;40:1422-4 Granger CB et al. Lancet 2003;362:772-6

  30. Angiotensin Receptor Blockers Used in Clinical Trials

  31. HFSA 2010 Practice Guideline (7.14-7.15)Pharmacologic Therapy: Aldosterone Antagonists • An aldosterone antagonist is recommended for patients on standard therapy, including diuretics, who have: • NYHA class IV HF (or class III, previously class IV) HF from reduced LVEF (≤ 35%) • One should be considered in patients post-MI with clinical HF or diabetes and an LVEF < 40% who are on standard therapy, including an ACE inhibitor (or ARB) and a beta blocker. Strength of Evidence = A Adapted from:

  32. RALES (Advanced HF) Aldosterone Antagonists in HF EPHESUS (Post-MI) Eplerenone Probability of Survival Spironolactone Placebo Placebo RR = 0.70 P < 0.001 RR = 0.85 P < 0.008 Months Pitt B. N Engl J Med 1999;341:709-17 Pitt B. N Engl J Med 2003;348:1309-21

  33. HFSA 2010 Practice Guideline (7.16-7.18) Aldosterone Antagonists and Renal Function • Aldosterone antagonists are not recommended when: • Creatinine > 2.5mg/dL (or clearance < 30 mL/min) • Serum potassium> 5.0 mmol/L • Therapy includes other potassium-sparing diuretics Strength of Evidence = A • It is recommended that potassium be measured at baseline, then 1 week, 1 month, and every 3 months Strength of Evidence = A • Supplemental potassium is not recommended unless potassium is < 4.0 mmol/L Strength of Evidence = A Adapted from:

  34. HFSA 2010 Practice Guideline (7.19)Pharmacologic Therapy:Hydralazine and Oral Nitrates • A combination of hydralazine and isosorbide dinitrate is recommended as part of standard therapy, in addition to beta-blockers and ACE-inhibitors, for African Americans with HF and reduced LVEF: • NYHA III or IV HF Strength of Evidence = A • NYHA II HF Strength of Evidence = B

  35. A-HeFT Outcomes Taylor AL et al. N Engl J Med 2004; 351;2049-57

  36. A-HeFT All-Cause Mortality 43% Decrease in Mortality Survival % Fixed Dose ISDN/HDZN Placebo P = 0.01 Days Since Baseline Visit Taylor AL et al. N Engl J Med 2004;351:2049-57

  37. HFSA 2010 Practice Guideline (7.23)Pharmacologic Therapy: Diuretics • Diuretic therapy is recommended to restore and maintain normal volume status in patients with clinical evidence of fluid overload, generally manifested by: • Congestive symptoms • Signs of elevated filling pressuresStrength of Evidence = A • Loop diuretics rather than thiazide-type diuretics are typically necessary to restore normal volume status in patients with HF.Strength of Evidence = B

  38. HFSA 2010 Practice Guideline (7.24)Pharmacologic Therapy: Diuretics • Restoration of normal volume status may require multiple adjustments. • Once a diuretic effect is achieved with short-acting loop diuretics, increase frequency to 2-3 times a day if necessary, rather than increasing a single dose.Strength of Evidence = B • Oral torsemide may be considered in patients exhibiting poor absorption of oral medication or erratic diuretic effect.Strength of Evidence = C • IV administration of diuretics may be necessary. Strength of Evidence = A • Diuretic refractoriness may represent patient nonadherence, a direct effect of diuretic use on the kidney, or progression of underlying dysfunction. Adapted from:

  39. Loop Diuretics

  40. Potassium-Sparing Diuretics

  41. HFSA 2010 Practice Guideline (9.1, 9.4)Device Therapy:Prophylactic ICD Placement • Prophylactic ICD placement should be considered in patients with an LVEF ≤35% and mild to moderate HF symptoms: • Ischemic etiology Strength of Evidence = A • Non-ischemic etiology Strength of Evidence = B • In patients who are undergoing implantation of a biventricular pacing device, use of a device that provides defibrillation should be considered.Strength of Evidence = B • Decisions should be made in light of functional status and prognosis based on severity of underlying HF and comorbid conditions, ideally after 3-6 mos. of optimal medical therapy.Strength of Evidence = C Adapted from:

  42. 1.0 .9 .8 Defibrillator Probability of Survival .7 Conventional Therapy .6 0 0 1 2 3 4 Year • Number at Risk • 742 • 503 (.91) • 274 (.84) • 110 (.78) • 9 • Defibrillator • 490 • 329 (.90) • 170 (.78) • 65 (.69) • 3 • Conventional MADIT II: Prophylactic ICD in Ischemic LVD (LVEF 30%) Moss AJ et al. N Engl J Med 2002;346:877-83 Moss AJ, et al. N Engl J Med. 2002;346;877-883.

  43. ICD Therapy in the SCD-HeFT Trial: Mortality by Intention-to-Treat .4 .3 22% .2 Mortality 17% .1 Amiodarone ICD Therapy Placebo 0 0 6 12 18 24 30 36 42 48 54 60 Months of Follow-Up Bardy GH et al. N Engl J Med 2005;352:225-37

  44. HFSA 2010 Practice Guideline (9.7)Device Therapy:Biventricular Pacing • Biventricular pacing therapy is recommended for patients with all of the following: • Sinus rhythm • A widened QRS interval (≥120 ms) • Severe LV systolic dysfunction (LVEF < 35%) • Persistent, moderate-to-severe HF (NYHA III) despite optimal medical therapy.Strength of Evidence = A

  45. CRT Improves Quality of Life and NYHA Functional Class (%) *P<.05 Abraham WT et al. Circulation 2003;108:2596-603

  46. CRT in Patients with Advanced HF and a Prolonged QRS Interval: COMPANION Primary End Point: All-Cause Mortality Death or Hospitalization Due to HF Risk of all-cause mortality reduced by 19% in group with CRT and ICD (p =.014) Risk of death or hospitalization from HF reduced by 34% in ICD group and by 40% in ICD-CRT group (p < .001) Bristow MR et al. N Engl J Med 2004;350:2140-50

  47. 100 75 CRT % Event-Free Survival 50 Medical Therapy 25 0 0 500 1,000 1,500 Days • Number at risk • 409 • 376 • 351 • 213 • 89 • 8 • 404 • 365 • 321 • 192 • 71 • 5 • CRT • Medical Therapy Effect of CRT Without an ICD on All-Cause Mortality: CARE-HF HR = 0.64 (95% CI = .48-.85) p = .0019 Cleland JG et al. N Engl J Med 2005;352:1539-49

  48. HFSA 2010 Practice Guideline (11.1-11.2)HF with Preserved LVEF—Diagnosis • Careful attention to differential diagnosis is recommended in patients with HF and preserved LVEF. • Treatments may differ based on cardiac disorder. • Evaluation for ischemic disease and inducible myocardial ischemia should be included. • Recommended diagnostic tools: • Echocardiography • Electrocardiography • Stress imaging (via exercise or pharmacologic means, using myocardial perfusion or echocardiographic imaging) • Cardiac catheterization Strength of Evidence = C Adapted from:

  49. Figure 11.3. Diagnostic Algorithmfor HF with Preserved LVEF No inducible ischemia, fibrotic, collagen- Vascular, RCM, cardinoid, diabetes, Radiation or chemotherapy induced heart disease, infiltrative disease, co- morbid conditions, reconsider diagnosis of HF

  50. HFSA 2010 Practice Guideline (12.3, Table 12.3)Acute Decompensated Heart Failure (ADHF)—Treatment Goals for Hospitalized Patients • Improve symptoms, especially congestion and low-output symptoms • Optimize volume status • Identify etiology • Identify precipitating factors • Optimize chronic oral therapy; minimize side effects • Identify who might benefit from revascularization • Education patients concerning medication and HF self-assessment • Consider enrollment in a disease management program Strength of Evidence = C

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