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lICENSE To Treat Failure: An updated approach

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1 lICENSE To Treat Failure: An updated approach
CDR Timothy Murray CHF Clinic Manager Internal Medicine Team Inpatient Pharmacy Clinical Coordinator Claremore Indian Hospital Clinical Assistant Professor University of Oklahoma Primary Care Cardiology Update April 9, 2011

2 Case #1 PT is a 37 yo white male whom is being consulted to the Internal Medicine service today secondary to an CHF exacerbation. JS presented to the ER with a 5 day history of increased shortness of breath and 10 lb weight increase. Symptoms started after a recent trip where a “poor” diet was consumed. Family Hx: DM, CAD Social Hx: negative PMH: HTN, CAD Medication prior to admission: Atenolol 25mg BID, aspirin 81mg daily, fish oil 1000mg daily, tamsulosin 0.4mg daily, KCL 8meq daily, furosemide 20mg daily

3 Case #1 Vitals: BP- 152/77, HR-101, WT- 177lbs

4 Case #1 Physical Exam: CHEST/LUNGS: Chest: Nontender
Lungs: RALES Bilateral mostly at right base, no wheezing CARDOVASCULAR: Cardiac: regular rate, regular rhythm, No murmur Pulses: Equal, DIMINISHED Very diminished at feet. Carotid: No bruit JVD: distended Abd aorta: No Bruit Lower ext: BILATERAL Edema of both legs mostly right side 3/4 and 2/4 at left.

5 Case #1 PT is treated in the hospital for 3 days. Weight has decreased 15 lbs and he feels much better. PT is to be seen in the CHF clinic in 2weeks for medication adjustment, dietary education, and monitoring. Completed echocardiogram reveals an ejection fraction of 25% PT returns to CHF clinic in 2wks with the following labs: PNBP: 3200

6 Case #1 Based upon the above case what type of interventions would you have expected to have been performed? (during admission or in clinic) A. Continue all medications prior to admission B. Increase Atenolol, start an ace-inhibitor, & start an aldosterone antagonist C. DC atenolol, start metoprolol succinate, & start an ace-inhibitor D. DC atenolol, start carvedilol, & start an ace-inhibitor E. Just give up and discharge patient from clinic!!!

7 Heart Failure Background
Population Group Prevalence Incidence Mortality Hospital Discharges Cost Total population 4,900,000 550,000 51,546 999,000 $24.3 billion 1 Heart failure (HF) is a major public health problem resulting in substantial morbidity and mortality Major cost-driver of HF is high incidence of hospitalizations1,2 JCAHO has initiated HF quality care indicators for hospitalized HF patients 1American Heart Association Heart and Stroke Statistical Update. Dallas, Tex: American Heart Association; 2002.

8 Estimated Direct and Indirect Costs of Heart Failure in US
Total Cost $25.8 billion Hospitalization $13.6 53% Nursing Home $3.5 14% 7% 8% 8% Lost Productivity/ Mortality* $2.1 10% Physicians/Other Professionals $1.8 Drugs/Other Medical Durables $2.7 Home Healthcare $2.1 *Lost future earnings of persons who will die in 2004, discounted by 3% AHA. Heart Disease and Stroke Statistics—2004 Update

9 Causes of Hospital Readmission for Congestive Heart Failure
Over 2/3 of HF Hospitalizations Preventable Diet Noncompliance 24% Rx Noncompliance 24% 16% Inappropriate Rx Approximately 50% of the hospitalizations for acute CHF are a result of noncompliance, with 24% of readmissions due to failure to comply with diet and 24% due to failure to comply with prescribed treatments. Failure to seek care (19%), inappropriate prescribing (16%), and other reasons (17%) comprise the remainder of causes of hospital readmission for HF. “Other” includes arrhythmia-related decompensation, pneumonia, distrust of physician, acute ischemia and infections. 17% Other 19% Failure to Seek Care Annals of Internal Medicine 122:415-21, 1995

10 Why a Hospital-based System for HF Management?
Patients Patient capture point Have patient’s/family’s attention: “teachable moment” Predictor of care in community Hospital structure Standardized processes / protocols / teams Accrediting bodies for standards of care Centers for Medicare and Medicaid Services—peer review organization Note to field personnel: with this slide, be sure to address positive CAD and Stroke experience thus far

11 Benefits & Drawbacks of HF Disease Management Programs
Improved use of evidence- based therapy Improved symptom status and functional capacity Improved QOL Reduction in hospitalization Decrease in total medical costs Usual Care Ask gregg what is the drawback…plz speak to this slide HF Disease Management Program Moser DK, Mann DL. Circulation. 2002;105:2810–2812.

12 How did we get into this CHF mess??
Where did our process break down and why no reduction in hospitalizations or re-hospitalizations? Sub-optimal utilization of guidelines No standardization of care (standing orders) No team approach to treating CHF No increase in intensity of HF care after hospital discharge

13 How to get out of this CHF mess??
National registry Develop a treatment plan (protocol) Utilize a team approach to treating CHF Provide a comprehensive service to monitor & make clinical alterations with patient’s treatment plan Provide patient education & training to involve patients in their treatment plan Follow-up on patients discharged after a CHF admission to avoid re-admission: CHF Clinic!!!!!! Implement & utilize national standards of care for CHF GET UP TO DATE WITH THE CHF GUIDELINES! Document – Document - Document!

14 CMS Center of Medicaid & Medicare Services Joint Commission/ACC/AHA
Compliance rates for discharging CHF pts Joint Commission/ACC/AHA CHF Performance Measures

15 CMS CHF Core Measures 1. Documentation of discharge instructions
2. Left ventricular function assessment 3. Use of ACE-I or ARB in pts with left ventricular systolic failure 4. Documentation of smoking cessation

16 CMS Hospitals should strongly consider implementing a process of care to ensure these measures are obtained and proper documentation occurs. The principal outcome measure of the ADHERE Registry was to assess overall hospital adherence to each of these measures for participating hospitals.

17 CMS CMS 2009 Documentation privileges for pharmacists!
Electronic Health Record advantages GIPRA Measures/Performance Improvements 2010 CMS 30 day readmission policy changes Beta Blockers?

18 Medications Ace-Inhibitors Beta-Blockers Aldosterone Antagonists ARBs
ISDN/Hydralazine Diuretics Digitalis Antiplatelets Statins Fish Oils Calcium Channel Blockers

19 Guidelines Never Die CHF care driven by two sets of national guidelines American College of Cardiology/American Heart Association Heart Failure Society of America

20 Guidelines Never Die Both organizations provide a set of detailed treatment guidelines for practitioners in an effort to optimize the management of chronic CHF. Treatment guidelines provide an approach to practice evidence based medicine.

21 CHF National Guidelines
Heart Failure Society of America Last update: June 2010 American College of Cardiology/American Heart Association Last update: April 2009

22 Guidelines 2009 ACC/AHA recommendation for:
“implementation of practice based guidelines utilizing multidisciplinary disease-management programs in efforts to assist in the treatment of patients with CHF”.

23 Guidelines 2010 HFSA recommendation for:
“patients recently hospitalized for HF & other patients at high risk for HF decompensation should be considered for comprehensive HF disease management.”

24 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 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. Journal of Cardiac Failure Vol. 16 No

25 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 Journal of Cardiac Failure Vol. 16 No

26 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

27 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

28 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 Journal of Cardiac Failure Vol. 16 No

29 ACE Inhibitors in Heart Failure: From Asymptomatic LVD to Severe HF
CONSENSUS (Severe Heart Failure) 40% mortality at 6 mos. 31% mortality at 1 year 27% mortality at end of study SOLVD Prevention (Asymptomatic LVD) 20% death or HF hosp. 29% death or new HF 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:

30 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.

31 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 Journal of Cardiac Failure Vol. 16 No

32 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. Journal of Cardiac Failure Vol. 16 No

33 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:

34 HFSA 2010 Practice Guideline (7
HFSA 2010 Practice Guideline (7.8) Pharmacologic Therapy: Beta Blockers 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 Journal of Cardiac Failure Vol. 16 No

35 HFSA 2010 Practice Guideline (7
HFSA 2010 Practice Guideline (7.11) Pharmacologic Therapy: Beta Blockers 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 Journal of Cardiac Failure Vol. 16 No

36 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:

37 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 Journal of Cardiac Failure Vol. 16 No

38 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.

39 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 Journal of Cardiac Failure Vol. 16 No

40 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. Journal of Cardiac Failure Vol. 16 No

41 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.

42 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 Journal of Cardiac Failure Vol. 16 No

43 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

44 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.

45 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 Journal of Cardiac Failure Vol. 16 No

46 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:

47 Aldosterone antagonists are not recommended when:
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 Journal of Cardiac Failure Vol. 16 No

48 EMPHASIS-HF Trial of 2737 patients with NYHA class 2 heart failure and an ejection fraction of no more than 35%. Patients were randomized to eplerenone (up to 50mg daily) or placebo in addition to recommended therapy. Measured outcomes included: cardiovascular death/heart-failure hospitalization, cardiovascular death, heart-failure hospitalization, and hospitalization for hyperkalemia. Trial was stopped early at 21months.

49 Adjusted hazard ratio (95% CI)
EMPHASIS-HF EMPHASIS-HF Major results Results in a 37% reduction in the primary end point of the composite of death from cardiovascular causes or hospitalization for heart failure!! Hyperkalemia occurring in 11.8% of eplerenone patients vs 7.2% of those in placebo group!!! Outcome Eplerenone (%) Placebo (%) Adjusted hazard ratio (95% CI) P Cardiovascular death/heart-failure hospitalization 18.3 25.9 0.63 ( ) < 0.001 Cardiovascular death 10.8 13.5 0.76 ( ) 0.01 Heart-failure hospitalization 12.0 18.4 0.58 ( ) Hospitalization for hyperkalemia 0.3 0.2 1.15 ( ) 0.85

50 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. Journal of Cardiac Failure Vol. 16 No

51 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;

52 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:

53 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. Journal of Cardiac Failure Vol. 16 No

54 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. Journal of Cardiac Failure Vol. 16 No

55 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. Journal of Cardiac Failure Vol. 16 No

56 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) Journal of Cardiac Failure Vol. 16 No

57 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 Journal of Cardiac Failure Vol. 16 No

58 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

59 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 Journal of Cardiac Failure Vol. 16 No

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

61 Antiplatelets For years the discussion has been which antiplatelet regimen is ideal for CHF pts? ASA Warfarin Plavix WASH Trial WATCH Trial

62 Congestive Heart Failure Hypertension Age > 75 Diabetes
Risk Stratification CHADS2 Congestive Heart Failure Hypertension Age > 75 Diabetes Stroke or TIA (2 points)

63 Risk Stratification CHA2DS2-VAS Score Congestive heart failure/LV 1
dysfunction Hypertension Age > 75 years 2 Diabetes mellitus 1 Stroke/TIA Vascular disease (prior MI, peripheral vascular disease) Age years 1 Female sex

64 Selecting an Antiplatelet “Gadget”
Patient Factors ASA Plavix Warfarin Myocardial Infarction <12months ago X Stent <12months ago Atrial Fibrillation (CHADS2 score 0-1) Atrial Fibrillation (CHADS2 score >2) X or Dabigatran Diabetes BYPASS Hx

65 Selecting an Antiplatelet “Gadget”
Patient Factors ASA Plavix Warfarin EF% < 30% X Systolic Failure w/ EF% >30% Diastolic Failure Severe CAD (no surgery option) LVAD

66 HFSA 2010 Practice Guidelines
New Recommendation VTE prophylaxsis with low dose unfractionated heparin, LMWH, or fondaparinux to prevent proximal deep venous thrombosis and pulmonary embolism is recommended for patients who are admitted to the hospital with ADHF and who are not already anticoagulated & have no contraindication. (Strength of Evidence=B)

67 A View To A Trial IMPROVE-HF Omega-3 (PUFAs) SELECT Trial Irbesartan
Yancy CW, Fonarow GC, Albert NM, et al. Influence of patient age and sex on delivery of guideline-recommended heart failure care in the outpatient cardiology practice setting: Findings from IMPROVE HF. American Heart Journal. 2009;157: Omega-3 (PUFAs) Tavazzi L, Maggioni AP, Marchioli R, et al. Effect of n-3 polyunsaturated fatty acids in patients with chronic heart failure (the GISSI-HF trial): a randomized, double-blind, placebo-controlled trial. Lancet 2008;372: SELECT Trial Zebrack J, Munger M, MacGregor J, et al. B-Receptor Selectivity of Carvedilol and Metoprolol Succinate in Patients with Heart Failure (SELECT Trial): A randomized Dose-Ranging Trial. Pharmacotherapy. 2009;29(8): Irbesartan Massie b, Carson P, et al. Irbesartan in Patients with Heart Failure & Preserved Ejection Fraction (I-Preserve Trial). NEJM. 2008;359(23): HFSA “The Heart Failure Clinic A Consensus Statement” J Card Fail. 2008;14: Centers for Medicare and Medicaid Services 30 day congestive heart failure readmission rates.

68

69 No significant differences in the patients’ global assessment of symptoms or in changes from baseline renal function with either bolus as compared with continuous infusion of intravenous furosemide or with a low-dose strategy as compared with a highdose strategy.

70 Hospital Quality Compare

71 Hospital Quality Compare

72 From Seattle With Love Teaching tool to utilize with CHF patients
Provides 5yr survival rate for patients based upon clinical history and no intervention as compared to rate after intervention. User friendly Internet based

73 From Seattle With Love

74 From Seattle With Love

75 Case #1 Based upon the above case what type of interventions would you have expected to have been performed? (during admission or in clinic) A. Continue all medications prior to admission B. Increase Atenolol, start an ace-inhibitor, & start an aldosterone antagonist C. DC atenolol, start metoprolol succinate, & start an ace-inhibitor D. DC atenolol, start carvedilol, & start an ace-inhibitor E. Just give up and discharge patient from clinic!!!

76 Questions???


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