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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 “Should be considered”
HFSA 2010 Comprehensive Heart Failure Practice Guideline Strength of Recommendation “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

3 A B C Randomized controlled trials Cohort and case control studies
HFSA 2010 Comprehensive Heart Failure Practice Guideline Strength of Evidence 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

4 HFSA 2010 Practice Guideline (3.1) Heart Failure Prevention
A careful and thorough clinical assessment, with appropriate investigation for known or potential risk factors, is recommended in an effort to prevent development of LV remodeling, cardiac dysfunction, and HF. Strength of Evidence = A Risk factors include: hypertension, hyperlipidemia, atherosclerosis, diabetes, valvular disease, obesity, physical inactivity, excessive alcohol intake, smoking Reference for hypertension: Levy D et al. The progression from hypertension to congestive heart failure. JAMA 1996;275: Adapted from:

5 HFSA 2010 Practice Guideline (3.2) HF Risk Factor Treatment Goals
Hypertension Generally < 130/80 Diabetes See ADA guidelines1 Hyperlipidemia See NCEP guidelines2 Inactivity 20-30 min. aerobic 3-5 x wk. Obesity Weight reduction < 30 BMI Alcohol Men ≤ 2 drinks/day, women ≤ 1 Smoking Cessation Dietary Sodium Maximum 2-3 g/day 1Diabetes Care 2006; 29: S4-S42 2JAMA 2001; 285: The June 2006 AHA guide regarding exercise, “Making healthy food and lifestyle choices: Our guide for American adults,” recommends 30 minutes or more of aerobic exercise every day. The recommendations and a free brochure are available at or AHA-USA1. Adapted from:

6 Treating Hypertension to Prevent HF
Aggressive blood pressure control: Aggressive BP control in patients with prior MI: Decreases risk of new HF by ~ 50% 56% in DM2 Decreases risk of new HF by ~ 80% Data come primarily from SHEP study. Data regarding type 2 diabetes come from UKPDS study. Lancet 1991;338: (STOP-Hypertension JAMA 1997;278:212-6 (SHEP) UKPDS Group. UKPDS 38. BMJ 1998;317:

7 HFSA 2010 Practice Guideline (3. 3-3
HFSA 2010 Practice Guideline ( ) 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 factor Strength 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
Placebo HOPE Treatment with ACE inhibitors decreases the risk of CV death, MI, stroke, or cardiac arrest. NEJM 2000;342: (HOPE) Lancet 2003;362:782-8 (EUROPA) Ramipril 22% rel. risk red. p < .001 In the HOPE study, relative risk of the composite outcome of MI, stroke, or death from CV causes in the ramipril group as compared with the placebo group was 0.78 at five years. In EUROPA the relative risk reduction of CV death, MI, or cardiac arrest was 20%. 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) There was no difference between the carvedilol and placebo groups in the primary endpoint of all-cause mortality or hospital admission for cardiovascular problems (HR = .92 ; CI = ). Dargie HJ. Lancet 2001;357:

11 HFSA 2010 Practice Guideline (4. 8, 4
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 compliance Strength of Evidence = C *Metrics to consider include the 6-minute walk test and NYHA functional class Other assessment metrics not addressed in this portion of the guideline include metabolic stress testing and BNP testing. BNP testing is discussed extensively in the section on acute decompensated HF. 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
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 MI Strength of Evidence = B Non Post-MI Strength of Evidence = C Adapted from:

14 ACE Inhibitors in Heart Failure: From Asymptomatic LVD to Severe HF
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 SOLVD Treatment (Chronic Heart Failure) SOLVD Prevention also showed a 37% reduction in the development of new HF and a 44% reduction in multiple hospitalizations for HF. The patients in SOLVD Treatment had an LVEF < 35%. Largest reduction in deaths were among those attributed to progressive HF. There was also a 26% reduction among those who died or were hospitalized due to worsening HF. Reduced mortality in CONSENSUS due to impact on progression of disease severity, rather than on sudden cardiac death.. 16% mortality SOLVD Investigators. N Engl J Med 1992;327:685-91 SOLVD Investigators. N Engl J Med 1991;325: CONSENSUS Study Trial Group. N Engl J Med 1987;316:

15 ACE Inhibitors Used in Clinical Trials
Generic Name Trade Name Initial Daily Dose Target Dose Mean Dose in Clinical Trials Captopril Capoten 6.25 mg tid 50 mg tid 122.7 mg/day Enalapril Vasotec 2.5 mg bid 10 mg bid 16.6 mg/day Fosinopril Monopril 5-10 mg qd 80 mg qd N/A Lisinopril Zestril, Prinivil 2.5-5 mg qd 20 mg qd 4.5 mg/day, mg/day* Quinapril Accupril 5 mg bid Ramipril Altace mg qd 10 mg qd Trandolapril Mavik 1 mg qd 4 mg qd NOTE THAT SPECIFIC LANGUAGE OF RECOMMENDATIONS SHOULD BE CONSULTED. *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
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
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 MI Strength of Evidence = B Non Post-MI Strength of Evidence = C Beta blockers shown to be effective in clinical trials include carvedilol, bisoprolol, and metoprolol succinate. See slide 17.

18 Effect of Beta Blockade on Outcome in Patients With HF and Post-MI LVD
Study Drug HF Severity Target Dose (mg) Outcome US Carvedilol1 carvedilol mild/ moderate BID ↓48% disease progression (p= .007) CIBIS-II2 bisoprolol moderate/ severe 10 QD ↓34% mortality (p <.0001) MERIT-HF3 metoprolol succinate 200 QD ↓34% mortality (p = .0062) COPERNICUS4 severe 25 BID ↓35% mortality (p = .0014) CAPRICORN5 post-MI LVD ↓23% mortality (p =.031) 1Colucci WS et al. Circulation 1196;94: CIBIS II Investigators. Lancet 1999;353:9-13. 3MERIT-HF Study Group. Lancet 1999;353: Packer M et al. N Engl J Med 2001;344 The CAPRICORN Investigators. Lancet 2001;357:

19 RECENT DECOMPENSATION
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
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 % of Patients With Event Weeks After Randomization
COPERNICUS: Death, Hospitalization, or Study Drug Withdrawal in High Risk Patients 30 HR = 0.67 (CI = ) 20 Placebo % of Patients With Event 10 Carvedilol Differences in favor of carvedilol appear as early as 4-21 days. 2 4 6 8 Weeks After Randomization Krum H et al. JAMA 2003;289:754-6 Krum et al. JAMA 2003;289

22 Carvedilol Predischarge Initiation Postdischarge Initiation*
IMPACT-HF Primary End Point: Patients Receiving Beta Blocker at 60 Days Improvement 18% Initiation of a beta blocker prior to hospital discharge is safe and well tolerated in the majority of patients and dramatically improves utilization of this evidence-based therapy following discharge. Carvedilol Predischarge Initiation (n=185) Physician Discretion Postdischarge Initiation* (n=178) Gattis WA et al. JACC 2004;43:

23 HFSA 2010 Practice Guideline (7
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. Use with 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 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 0.5 1.0 1.5 2.0 This slide shows relative risks for the combined end point of mortality and hospitalization owing to heart failure in patients with and without diabetes in the COPERNICUS1 and MERIT-HF2 trials. 1. Mohacsi P, Fowler MB, Krum H, et al. Should physicians avoid the use of beta-blockers in patients with heart failure who have diabetes? Results of the COPERNICUS Study. Circulation. 2001;104(17):abstr 3551. 2. Hjalmarson A, Goldstein S, Fagerberg B, et al. Effects of controlled-release metoprolol on total mortality, hospitalizations, and well-being in patients with heart failure: the Metoprolol CR/XL Randomized Intervention Trial in Congestive Heart Failure (MERIT-HF). JAMA. 2000;283(10): Mohacsi. Circulation. 2001;104(17):abstr 3551. Hjalmarson. JAMA. 2000;283(10):1295.

25 HFSA 2010 Practice Guideline (11. 8, 15
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 MI Strength of Evidence = A Hypertension Strength of Evidence = B Atrial fib. requiring control of ventricular rate Strength 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). There are no studies looking specifically at the impact of beta blockers on patients with HF and preserved LVEF or on the elderly with HF. However, the use of beta blockers in patients with HF and the concomitant conditions listed in this recommendation is well established, and the elderly are represented in most HF trials. Strength of Evidence = C

26 HFSA 2010 Practice Guideline Pharmacologic Therapy: Beta Blocker Overview*
General considerations Initiate at low doses Up-titrate gradually, generally no sooner than at 2 week intervals Use target doses shown to be effective in clinical trials Aim to achieve target dose in 8-12 weeks Maintain at maximum tolerated dose If symptoms worsen or other side effects appear Adjust dose of diuretic or concomitant vasoactive med. Continue titration to target after symptoms return to baseline If up-titration continues to be difficult Prolong titration interval Reduce target dose Consider referral to a HF specialist NOTE THAT SPECIFIC LANGUAGE OF RECOMMENDATIONS SHOULD BE CONSULTED. *Consult language of specific recommendations Adapted from:

27 Beta Blockers Used in Clinical Trials
Generic Name Trade Name Initial Daily Dose Target Dose Mean Dose in Clinical Trials Bisoprolol Zebeta 1.25 mg qd 10 mg qd 8.6 mg/day Carvedilol Coreg 3.125 mg bid 25 mg bid 37 mg/day Coreg CR 80 mg qd Metoprolol succinate CR/XL Toprol XL mg qd 200 mg qd 159 mg/day NOTE THAT SPECIFIC LANGUAGE OF RECOMMENDATIONS SHOULD BE CONSULTED.

28 HFSA 2010 Practice Guideline (7
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 ARBS in Patients Not Taking ACE Inhibitors: Val-HeFT & CHARM-Alternative
Placebo Survival % Valsartan CV Death or HF Hosp % Placebo Candesartan The Val-HeFT paper cited here is a sub-group analysis of study participants not on an ACE inhibitor (N=366); they were not defined as ACE-intolerant. This table shows a reduction in all-cause mortality from 27.1% in the placebo group to 17.3% in the group treated with valsartan. CHARM-Alternative enrolled 2028 patients not receiving ACEI due to previous intolerance. Primary outcome was composite of cardiovascular death or hospital admission for HF. At median follow up of 33.7 months, 33% of the patients in the candesartan group and 40% of the patients in the placebo group had CV death or HF hospitalization p = 0.017 HR 0.77, p = 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
Generic Name Trade Name Initial Daily Dose Target Dose Mean Dose in Clinical Trials Candesartan Atacand 4-8 mg qd 32 mg qd 24 mg/day Losartan Cozaar mg qd 150 mg qd 129 mg/day Valsartan Diovan 40 mg bid 160 mg bid 254 mg/day NOTE THAT SPECIFIC LANGUAGE OF RECOMMENDATIONS SHOULD BE CONSULTED.

31 HFSA 2010 Practice Guideline (7. 14-7
HFSA 2010 Practice Guideline ( ) 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. Renal function issues on next slide. Strength of Evidence = A Adapted from:

32 Aldosterone Antagonists in HF
EPHESUS (Post-MI) RALES (Advanced HF) 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:

33 HFSA 2010 Practice Guideline (7. 16-7
HFSA 2010 Practice Guideline ( ) 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 Starting doses: Spironolactone 12.5 mg PO QD (or 6.25 mg in high risk patient); Epleronone 25 mg QD Target doses: Advance spironolactone at 4 weeks to 25mg PO QD;Advance epleronone at 4 weeks to 50 mg QD Avoid higher doses Adapted from:

34 HFSA 2010 Practice Guideline (7
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 This represents one of the key differences between the HFSA guideline and the AHA/ACC guideline, since this is a stronger recommendation for HDZN/ISDN.

35 A-HeFT Outcomes End point ISDN-HDZN (n=518) Placebo (n=532) p
Primary end point composite score -0.1 -0.5 0.01 All-cause mortality (%) 6.2 10.2 0.02 1st HF hospitalization (%) 16.4 24.4 0.001 Change in quality-of-life score at 6 months** -5.5 -2.7 A-HeFT: African American Heart Failure Trial Composite endpoint includes last three items on table: All-cause mortality First HF hospitalization Change in QOL score at 6 months (lower score indicates better QOL) Study enrolled 1050 self-reported African American patients will NYHA III-IV HF. Data monitoring board stopped study after 10 months of follow up due to mortality increase in placebo group. Significant outcomes showed a 43% decrease in mortality and a 39% drop in HF hospitalizations among those in the group receiving isisorbide dinitrate/hydralazine. A-HeFT used a novel primary end point consisting of weighted values for all-cause death, first hospitalization for HF, and change in quality of life according to the Minnesota Living with Heart Failure questionnaire. Possible scores ranged from +6 to -2. Taylor AL et al. N Engl J Med 2004; 351;

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:

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 pressures Strength 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 Congestive symptoms include orthopnea, edema, and shortness of breath. Signs of elevating filling pressures include jugular venous distention, peripheral edema, pulsatile hepatomegaly, and, less commonly, rales.

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 Agent Initial Daily Dose Max Total Daily Dose
Elimination: Renal – Met. Duration of Action Furosemide 20-40mg qd or bid 600 mg 65%R-35%M 4-6 hrs Bumetanide mg qd or bid 10 mg 62%R/38%M 6-8 hrs Torsemide 10-20 mg qd 200 mg 20%R-80%M 12-16 hrs Ethacrynic acid 25-50 mg qd or bid 67%R-33%M 6 hrs Although these are doses generally recommended for use in the treatment of HF, not necessarily indicated in the package inserts. Thus some recommendations might be off label.

40 Potassium-Sparing Diuretics
Agent Initial Daily Dose Max Total Daily Dose Elimination Duration of Action Spironolactone mg qd 50 mg Metabolic 48-72 hrs Eplerenone 25-50 mg qd 100 mg Renal, Metabolic Unknown Amiloride 5 mg qd 20 mg Renal 24 hrs Triamterene 50-75 mg bid 200 mg 7-9 hrs None are specifically indicated for heart failure. Epleronone is indicated for post-MI LV dysfunction. It is a diuretic, but is used in HF primarily for neurohormonal inhibition.

41 HFSA 2010 Practice Guideline (9. 1, 9
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 Before placement, LV function should be re-assessed, ideally after 3-6 months of optimal medical therapy. Adapted from:

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

43 ICD Therapy in the SCD-HeFT Trial: Mortality by Intention-to-Treat
HR 97.5% Cl P Value Amiodarone vs Placebo 1.06 .53 ICD vs Placebo .77 .007 .4 .3 22% Mortality .2 17% .1 Amiodarone ICD Therapy Placebo 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 A widened QRS interval (≥120 ms)
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 This represents another difference between the HFSA guideline and the AHA/ACC’s in that this is not as strong a recommendation.

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

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 Patients in the study group had advanced HF and a QRS interval of at least 120. There were three treatment arms: (1) optimal pharmacologic therapy (OPT) (2) OPT plus CRT (3) OPT-CRT plus an ICD 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:

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

48 HFSA 2010 Practice Guideline (11. 1-11
HFSA 2010 Practice Guideline ( ) 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 This is a transition to several special considerations in heart failure: HF with preserved LVEF Acute decompensated HF Strength of Evidence = C Adapted from:

49 Figure 11.3. Diagnostic Algorithm for 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 Improve symptoms, especially congestion and low-output symptoms
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

51 Fluid and sodium restriction Diuretics, especially loop diuretics
HFSA 2010 Practice Guideline ( ) Overview of Treatment Options for Patients with Acute Decompensated HF Fluid and sodium restriction Diuretics, especially loop diuretics Ultrafiltration/renal replacement therapy (in selected patients only) Parenteral vasodilators * (nitroglycerin, nitroprusside, nesiritide) Inotropes * (milrinone or dobutamine) *See recommendations for stipulations and restrictions.

52 HFSA 2010 Practice Guideline (12. 25, Table 12
HFSA 2010 Practice Guideline (12.25, Table 12.7) Discharge Criteria for Hospitalized ADHF Patients Recommended prior to discharge for all patients with HF: Exacerbating factors addressed Near optimum fluid status and pharmacologic therapy achieved Transition from IV to oral diuretic completed Patient education completed with clear discharge instructions Follow-up clinic visit scheduled, usually 7-10 days Should be considered prior to discharge for patients with advanced HF or a history of recurrent admissions: Oral regimen stable for 24 hours No IV inotrope or vasodilator for 24 hours Ambulation before discharge to assess functional capacity Plans for post-discharge management Referral for disease management, if available Items for post discharge planning: scale present in the home, visiting nurse or telemanagement follow up within 3 days of discharge. Strength of Evidence =C Adapted from:

53 Predictors of Mortality Based on Analysis of ADHERE Database
Classification and Regression Tree (CART) analysis of ADHERE data shows: Three variables are the strongest predictors of mortality in hospitalized ADHF patients: BUN > 43 mg/dL Systolic blood pressure < 115 mmHg Serum creatinine > 2.75 mg/dL Fonarow GC et al. JAMA 2005;293:572-80

54 HFSA 2010 Practice Guideline (8.1) Heart Failure Patient Education
It is recommended that patients with HF and their family members or caregivers receive individualized education and counseling that emphasizes self-care. This education and counseling should be delivered by providers using a team approach. Teaching should include skill building and target behaviors. Strength of Evidence = B The most intensive education is needed for patients in NYHA class III-IV. Examples of skills and target behaviors: Perform daily weights Develop action plan for notifying provider if symptoms change State reasons for taking medications Describe a plan for a missed dose State blood pressure goal and current blood pressure Demonstrate ability to read food label for sodium per serving Adapted from:

55 The Potential Impact of Effective Education on Patient Compliance
Nonadherence rate when patients . . . Recall MD advice Don’t recall advice Medications 8.7% 66.7% Diet 23.6% 55.8% Activity 76.4% 84.5% Smoking 60.0% 90.4% Alcohol 81.8% Potential improvement with medication compliance alone would have monumental economic and health impact. Shows importance of institutional compliance with “patient education before discharge” HF performance measure. Kravitz et al. Arch Int Med 1993;153:

56 Sample Target Behavior: Be Able to Read and Understand Food Labels
These are all labels from cups of dried soup. The two labels on the left are from the same brand and show the variability that can occur from one soup to another. The label on the right is from another brand and appears to show a much higher sodium content. But when you look at the servings per container (upper ovals), you see that the soups on the left have 2 per container, meaning you must double sodium content. As a result, the container on the left has the greatest amount of sodium—nearly 800 mg. Labels from cups of soup

57 HFSA 2010 Practice Guideline (8.7) Heart Failure Disease Management
Patients recently hospitalized for HF and other patients at high risk should be considered for referral to a comprehensive HF disease management program that delivers individualized care. Strength of Evidence = A High risk patients include those with renal insufficiency, low output state, diabetes, COPD, persistent NYHA class III or IV symptoms, frequent hospitalization for any cause, multiple active co-morbidities, or a history of depression, cognitive impairment, or persistent non-adherence to therapeutic regimens. The evidence that led to the A rating was a collection of single-center randomized controlled trials. Examples include the following: Stewart S, MarleyJE, Horowitz JD. Effects of a multidisciplinary, home-based intervention on unplanned readmissions and survival among patients with congestive heart failure: a randomised controlled study. Lancet 1999;354: Intervention: Home visit be a nurse 7-14 days after discharge Results: During 6 month follow up there were 129 primary endpoint events (unplanned readmission for HF) in usual-care group, 77 in the treatment group (p = .02). More intervention group that usual-care patients remained event-free ( 38 vs. 51, p = .04). Rich MW, Beckham V, Wittenberg C, Leven CL, Freedland KE, Carney RM. A multidisciplinary intervention to prevent the readmission of elderly patients with congestive heart failure. N Engl J Med 1995;333: Intervention: Nurse-directed multidisciplinary intervention on high risk hospitalized patients 70 or older. Results: Risk ratio for readmission at 90 days .56 (p = .02). Quality of life improved at 90 days (p = .0001) Cline CM, Israelsson BY, Willenheimer RB, Broms K, Erhardt LR. Cost effective management programme for heart failure reduces hospitalisation. Heart 1998;80:442-6. Intervention: Education on HF and self-management with follow-up at nurse-directed HF clinic for 1 year after discharge. Results: No difference in survival rate at 1 year. Mean time to readmission 141 days in treatment vs. 106 in control (p < .05). Days in hospital fewer for treatment, but at p = .07 level. Doughty RN, Wright SP, Pearl A, Walsh HJ, Muncaster S, Whalley GA, et al. Randomized, controlled trial of integrated heart failure management: The Auckland Heart Failure Management Study. Eur Heart J 2002;23: Intervention: Clinical review at hospital-based HF clinic early after discharge, education sessions, personal diary, information booklets, and regular follow up at HF clinic and PC practitioner. Results: No significant difference in groups for combined endpoint of death or readmission. Quality of life improved in treatment group at 12 months (p = .015). Readmissions were 56 in the treatment group vs 95 in the control group (p = .015). Stromberg A, Martennson J, Fridlund B, Leven LA, Karlsson JE, Dahlstrom U. Nurse-led heart failure clinics improve survival and self-care behaviour in patients with heart failure: results from a prospective, randomized trial. Intervention: Follow-up at a nurse-led HF clinic. Results: Fewer patients with events (death or admission) in treatment group at 12 months (29 vs 40, p = .03). Fewer deaths after 12 months (7 vs 20, p = Treatment group had higher self-care scores at 3 and 12 months (p = .02 and p = .01). Adapted from:

58 HF Disease Management and the Risk of Readmission
Ratio Sample studies below. All are single-site studies or studies done at associated hospitals (see Naylor). Interventions range from a single home visit by a nurse (Stewart) to more complex and long-term strategies using a HF clinic. Cline CM, Israelsson BY, Willenheimer RB, Broms K, Erhardt LR. Cost effective management programme for heart failure reduces hospitalisation. Heart 1998;80:442-6. Intervention: Education on HF and self-management with follow-up at nurse-directed HF clinic for 1 year after discharge. Results: No difference in survival rate at 1 year. Mean time to readmission 141 days in treatment vs. 106 in control (p < .05). Days in hospital fewer for treatment, but at p = .07 level. Rich MW, Beckham V, Wittenberg C, Leven CL, Freedland KE, Carney RM. A multidisciplinary intervention to prevent the readmission of elderly patients with congestive heart failure. N Engl J Med 1995;333: Intervention: Nurse-directed multidisciplinary intervention on high risk hospitalized patients 70 or older. Results: Risk ratio for readmission at 90 days .56 (p = .02). Quality of life improved at 90 days (p = .0001) Naylor MD, Brooten DA, Campbell RL, Maislin G, McCauley KM, Schwartz JS. Transitional care of older adults hospitalized with heart failure: a randomized, controlled trial. J Am Geriatr Soc 2004;52:675-84 Intervention: 3-month advanced practice nurse-directed discharge planning and home follow-up in six hospitals. Mean age of patients 76. Results: Time to first readmission or death longer in study group (p = .026). At 1 year, study group had fewer readmissions (104 vs 162, p = .047). Improvements in QOL were only short-term. Stewart S, MarleyJE, Horowitz JD. Effects of a multidisciplinary, home-based intervention on unplanned readmissions and survival among patients with congestive heart failure: a randomised controlled study. Lancet 1999;354: Intervention: Home visit be a nurse 7-14 days after discharge Results: During 6 month follow up there were 129 primary endpoint events (unplanned readmission for HF) in usual-care group, 77 in the treatment group (p = .02). More intervention group that usual-care patients remained event-free ( 38 vs. 51, p = .04). Summary RR = 0.76 (95% CI ) Summary RR for randomized only = 0.75 (CI = )

59 HFSA 2010 Practice Guideline (8.13) End-of-Life Care in Heart Failure
End-of-life care should be considered in patients who have advanced, persistent HF with symptoms at rest despite repeated attempts to optimize pharmacologic, device, and other therapies, as evidenced by one or more of the following: HF hospitalization Strength of Evidence = C Chronic poor quality of life with inability to accomplish activities of daily living Strength of Evidence = C Need for continuous IV inotropic therapy support Strength of Evidence = C

60 Evidence-Based Treatment Across the Continuum of Systolic LVD and HF
Control Volume Improve Clinical Outcomes Diuretics Renal Replacement Therapy* Digoxin -Blocker ACEI or ARB Aldosterone Antagonist or ARB Treat Residual Symptoms CRT  an ICD* HDZN/ISDN* Clinical outcomes include reduced mortality, HF hospitalizations, and progressive LV remodeling. *In selected patients


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