MGMT of Heart failure_ Guideline 2013

Information about MGMT of Heart failure_ Guideline 2013

Published on August 5, 2014

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Management of Heart Failure Guideline 2013: Management of Heart Failure Guideline 2013 Dr. Vinod Sharma National Heart Institute New Delhi Heart Failure: Heart Failure “Clinical practice guidelines are systematically developed statements that aim to help physicians and patients reach the best healthcare decisions”. Relative place of clinical guidelines in the spectrum of drug or Interventional discovery and development to clinical trials and practice: Relative place of clinical guidelines in the spectrum of drug or Interventional discovery and development to clinical trials and practice Discovery and development of intervention Phases I, II, and III Clinical trials Statistical analyses Trial results and interpretations Regulatory authority approval, Publicity, marketing & sales Adoption into clinical practice Clinical Guidelines Therapeutic decisions Standards and quality of care clinical audits Classification of Recommendation & Level of Evidence: Classification of Recommendation & Level of Evidence Heart Failure: Heart Failure Heart Failure is a complex clinical syndrome that results from any structural or functional impairment of ventricular filling or ejection of blood. Heart Failure: Heart Failure The life time risk of developing heart failure is about 20% for people above age of 40 years. Heart Failure incidence increases with age rising from approximately 20 / 1000 individuals 65-69 years of age to > 80 /1000 individuals above the age of 85 years. Risk Factor for Heart Failure: Risk Factor for Heart Failure Hypertension Diabetes mellitus Metabolic syndrome Atherosclerotic disease Obstructive Sleep Apnoea Definitions of HFrEF & HFpEF: Definitions of HF r EF & HF p EF Classification EF (%) Heart Failure with reduced ejection fraction ( HF r EF ) < 40 Heart failure with preserved ejection fraction ( HF p EF ) > 50 HFpEF , borderline 41 to 49 b. HFpEF , improved > 40 Heart Failure: Heart Failure Stages of HF Survival rate @ 5 years A At high risk for HF but without structural heart disease or symptoms of HF . NYHA   97% B Structural heart disease but without signs or symptoms of HF . I 96% C Structural heart disease with prior or current symptoms of HF. I 75% II III D Refractory HF requiring specialized interventions IV 20% Diagnosis of Heart Failure: Diagnosis of Heart Failure “There is no single diagnostic test for Heart Failure. It is largely a clinical diagnosis based on careful history & physical examination”. Recommendations for Biomarkers in Heart Failure : Recommendations for Biomarkers in Heart Failure Biomarker, Application Setting COR LOE Natriuretic peptides Diagnosis or exclusion of HF Ambulatory, Acute I A Prognosis of HF Ambulatory, Acute I A Achieve GDMT Ambulatory IIa B Guidance of acutely decompensated HF therapy Acute IIb C Biomarkers of myocardial injury Additive risk stratification Acute, Ambulatory I A Biomarkers of myocardial fibrosis Additive risk stratification   Ambulatory   IIb B Acute IIb A Chronic therapy and outcomes in HF: Chronic therapy and outcomes in HF Drugs that decrease mortality : β -AR blockers ACE inhibitors Angio receptor blockers Aldosterone antagonists Isosorbide and hydralazine in blacks Drugs that may improve symptoms without worsening outcome: Cardiac glycosides Loop diuretics Drugs that increase mortality : Dobutamine Xamoterol Pimobendam Flosequinan Vesnarinone Ibopamine Inamrinone Milrinone Enoximone Surgical / Percutaneous / Trans Catheter Interventions in Heart Failure: Surgical or Percutaneous revascularization Surgical or Trans Catheter Aortic valve replacement. Surgical reverse remodelling or LV aneurysmectomy. Parachute device (Cardio Kinetix) (Catheter based LV partitioning) Hemodynamic support with PVAD’s Cardiac Transplantation Renal denervation Use of Mitra Clip (Percutaneous Mitral valve repair) Stem Cell therapy Surgical / Percutaneous / Trans Catheter Interventions in Heart Failure Device Therapy for Heart Failure: Device Therapy for Heart Failure Cardiac Resynchronization Therapy (CRT) Implantable Cardioverter Defibrillator (ICD) Selected clinical trials establishing the benefit of angiotensin-converting enzyme inhibitors in symptomatic and asymptomatic LV systolic function : Selected clinical trials establishing the benefit of angiotensin-converting enzyme inhibitors in symptomatic and asymptomatic LV systolic function Trial (Ref) (No. of patients; average follow up) Study population ACE inhibitor and dose Key results CONSENSUS I [22] (n = 253; 6 mo) NYHA IV Enalapril vs Placebo 2.5 mg twice daily titrated to 20 mg twice daily 6 month mortality decreased 40% 1-year mortality decreased 31% Improvement in NYHA class Decrease in cardiac size V- HeFT II [24] (n=804; 2.5 y) NYHA II – IV LVEF < 45% Target enalapril 10 mg twice daily vs hydralazine 75 mg four times daily + isosorbide dinitrate 40 mg four times daily 2 year mortality decreased 28% No difference in HF hospitalization Lesser improvement in exercise capacity and ventricular function with enalapril SOLVD Treatment Trial [65] (n = 2569; 41 mo) NYHA II – IV (90% II – III) LVEF < 35% Enalapril vs placebo 2.5 mg twice daily titrated to 10 mg twice daily 16% decrease in mortality 22% decrease in progressive HF mortality 26% decrease in either death or HF hospitalization 8.6 month increase in median life expectancy [76] SOLVD Prevention Trial [29] ( n = 4228; 37.4 month) NYHA I LVEF < 35% Enalapril vs placebo 2.5 mg twice daily titrated to 10 mg twice daily 20% decrease in either death or HF hospitalization 29% decrease in either death or development of HF Effects of Beta-blockers on mortality compared with placebo in the four positive landmark studies. US Carvedilol program, COPERNICUS, CIBIS II and MERIT-HF: Effects of Beta-blockers on mortality compared with placebo in the four positive landmark studies. US Carvedilol program, COPERNICUS, CIBIS II and MERIT-HF Randomized, Controlled Trials of ARBs in HF: Randomized, Controlled Trials of ARBs in HF TRIAL N AGENT ENTRY CRITERIA FOLLOW UP PERIOD PRIMARY ENDPOINT FINDINGS HEART FAILURE TRIALS ELITE-II 3152 Losartan vs Captopril Age > 60 yrs LVEF < 40% NYHA II – IV 1.5 years Death Losartan 18% Captopril 16% (13% ↓ , P = .16) Val- HeFT 5010 Valsartan vs Placebo LVEF < 40% LVID > 2.9 cm/m2 NYHA II - IV 23 months Death Death and complications Placebo 19% Valsartan 20% ( P = .80) Placebo 32% Valsartan 29% (13% ↓) CHARM-Added 2548 Candesartan vs Placebo LVEF < 40% NYHA II – IV Treatment with ACEIs 41 months CV death or HF hospitalization Placebo 42% Candesartan 38% (15% ↓) CHARM –Alternative 2028 Candesartan vs Placebo LVEF < 40% NYHA II – IV Intolerance to ACEIs 34 months CV death or HF hospitalization Placebo 40% Candesartan 33% (23% ↓) POSTINFARCTION TRIALS VALIENT 14,808 Valsartan vs Valsartan plus Captopril Vs Captopril 0.5 – 10 days after MI HF, LVEF < 35%, or both 25 months Death Valsartan 20% Valsartan plus Captorpril 19% Captopril 20% RALES (Randomized Aldactone Evaluation Study): RALES (Randomized Aldactone Evaluation Study) 30% reduction in all cause mortality as well as a reduced risk of SCD & HF hospitalization with use of Spironolactone in patient with chronic HF r EF and LVEF < 35%. NEJM 1999: 339: 387-95 Eplerenone reduces all cause deaths, CV deaths or HF hospitalization in a under range of patients with HF r EF. NEJM 2011: 364: 11-21 Hydralazine & ISDN Combination in Heart Failure : Hydralazine & ISDN Combination in Heart Failure This combination reduced Mortality but not hospitalization in patients with HF treated with Diuretics & Digoxin but not an ACEI or Beta-blockers. NEJM 1986: 314: 1547 – 52 ACEI has more favourable effect on survival than ISDN + HLZ. ISDN + HLZ is more effective in African – American population. Addition of fixed dose ISDN + HLZ to standard therapy with ACEI / ARB + BB + Aldosterone Antagonist offers significant benefit. NEJM 2004: 351: 2049 - 57 Medical Therapy for Stage C HFrEF: Magnitude of Benefit Demonstrated in RCTs: Medical Therapy for Stage C HF r EF: Magnitude of Benefit Demonstrated in RCTs GDMT RR Reduction in Mortality (%) NNT for Mortality Reduction (Standardized to 36 months) RR Reduction in HF Hospitalizations (%) ACE Inhibitor or ARB 17 26 31 Beta blocker 34 9 41 Aldosterone antagonist 30 6 35 Hydralazine / nitrate 43 7 33 Implantable Cardioverter Defibrillators (ICD): Implantable Cardioverter Defibrillators (ICD) ICD – well proven therapy in prevention of sudden cardiac death in heart failure population over the last decade. Summary of Implantable cardioverter defibrillator trials in patients with a cardiomyopathy due to CAD: Summary of Implantable cardioverter defibrillator trials in patients with a cardiomyopathy due to CAD Ischemic Cardiomyopathy Entry Criteria EF (%) Overall mortality (control; ICDs [%]) Mortality reduction (relative; absolute [%]) MADIT 2 – y ear analysis EF 35%, nonsustained or inducible VT 26 + 7 32; 13 59; 19 MUSTT 5 –year analysis EF < 40%, inducible VT 30 (21-35) 55; 24 58; 31 MADIT II 2 – year analysis EF < 30% 23 + 5 22; 16 28; 6 SCDHeFT 5 – year analysis EF < 35%, NYHA II, III, 52% CAD – CHF 25 (20 – 30) 36; 29 23; 7 Summary of Implantable cardioverter defibrillators trials in patients with a nonischemic cardiomyopathy: Summary of Implantable cardioverter defibrillators trials in patients with a nonischemic cardiomyopathy Nonischemic Cardiomyopathy Entry Criteria EF % (mean) Overall mortality (control; ICD [%]) DEFINITE 2 – year analysis EF < 36%, NSVT or > 10 PVCs / h 21.4 14.1; 7.9 SCDHeFT 5 – year analysis EF < 35%, NYHA II – III; 48% nonischemic CM 25 36; 29 Device Therapy for Stage C HFrEF (cont.): Device Therapy for Stage C HF r EF (cont.) Recommendations COR LOE ICD therapy is recommended for primary prevention of SCD in selected patients with HFrEF at least 40 days post-MI with LVEF ≤35%, and NYHA class II or III symptoms on chronic GDMT, who are expected to live ≥1 year* I A ICD therapy is recommended for primary prevention of SCD in selected patients with HFrEF at least 40 days post-MI with LVEF ≤30%, and NYHA class I symptoms while receiving GDMT, who are expected to live ≥1 year* I B Cardiac Resynchronization Therapy (CRT): Cardiac Resynchronization Therapy (CRT) CRT – optimizing right and left ventricular pacing, has been shown to improve hemodynamic parameters, symptoms and most recently mortality in patients with symptoms of congestive heart failure and depressed ejection fraction. Summary of cardiac resynchronization therapy trials: Summary of cardiac resynchronization therapy trials TRIAL Inclusion criteria : EF (%); QRS (ms) NYHA; mean EF(%); mean QRS (ms) End points Primary end point reduction cardiac resynchronization therapy control MIRACLE 6-month f/u (NEJM 2002) < 35; > 130 III – IV; 22; 166 NYHA, 6 MW, MLHFQ RR: 40% CE reduction COMPANION 1 – year f/u (NEJM 2004) < 35; > 130 III – IV; 21; 160 Mortality + HF events RR: 12% CE reduction; AR: mortality: CRT-P 4.6% CRT-D 11% CARE-HF 2-year f/u (NEJM 2005) < 35; > 120 III – IV; 25; 160 Mortality RR: 36% reduction AR: 20 vs 30% MADIT CRT 4.5 – year f/u (NEJM 2009) < 30; > 130 I – II; 24; 158 HF events + mortality RR: 29% CE reduction AR: 17.2 vs 25.3% RAFT 5-year f/u (NEJM 2010) < 30; > 120 II – III; 22.6; 158 Mortality RR 22% reduction AR: 28.6% CRT – D vs 34.6% ICD 6MW: 6-min walk; AR: Absolute reduction; CE: Combined end point; CRT-D: Cardiac resynchronization therapy defibrillator; CRT-P: cardiac Resynchronization therapy-pacemaker only; MLHFQ: Minnesota living with heart failure questionnaire; RR: Relative reduction Device Therapy for Stage C HFrEF: Recommendations: Device Therapy for Stage C HF r EF: Recommendations CRT is indicated for patients who have LVEF of 35% or less, sinus rhythm, left bundle-branch block (LBBB) with a QRS duration of 150 ms or greater, and NYHA class II, III, or ambulatory IV symptoms on GDMT (Level of Evidence: A for NYHA Class III / IV; Level of Evidence: B for NYHA class II). CRT – Indications in Heart Failure: CRT – Indications in Heart Failure LBBB (QRS > 150 msec) - NYHA class III / IV - Class Ia I / IV - Class Ib LBBB (QRS 120 – 149 msec) - NYHA Class IV - Class IIa / B Class III Non LBBB (QRS > 150 msec) - NYHA Class III / IV - Class IIa I/ II Non LBBB (QRS 120 – 149 msec) - NYHA Class III / IV - Class IIb I / II PowerPoint Presentation: Stage A Treatment of Stages A to D Stage A: Stage A Hypertension and lipid disorders should be controlled in accordance with contemporary guidelines to lower the risk of HF. Other conditions that may lead to or contribute to HF, such as obesity, diabetes mellitus, tobacco use, and known cardiotoxic agents, should be controlled or avoided. I IIa IIb III I IIa IIb III A Recommendations for Treatment of Stage B HF: Recommendations for Treatment of Stage B HF Recommendations COR LOE In patients with a history of MI and reduced EF, ACE inhibitors or ARBs should be used to prevent HF I A In patients with MI and reduced EF, evidence-based beta blockers should be used to prevent HF I B In patients with MI, statins should be used to prevent HF I A Blood pressure should be controlled to prevent symptomatic HF I A ACE inhibitors should be used in all patients with a reduced EF to prevent HF I A Beta blockers should be used in all patients with a reduced EF to prevent HF I C An ICD is reasonable in patients with asymptomatic ischemic cardiomyopathy who are at least 40 d post-MI, have an LVEF ≤30%, and on GDMT IIa B Nondihydropyridine calcium channel blockers may be harmful in patients with low LVEF III: Harm C PowerPoint Presentation: Nonpharmacological Interventions Treatment of Stages A to D Stage C: Nonpharmacological Interventions: Stage C: Nonpharmacological Interventions Patients with HF should receive specific education to facilitate HF self-care. Exercise training (or regular physical activity) is recommended as safe and effective for patients with HF who are able to participate to improve functional status. Sodium restriction is reasonable for patients with symptomatic HF to reduce congestive symptoms. I IIa IIb III B I IIa IIb III I IIa IIb III A Stage C: Nonpharmacological Interventions (cont.): Stage C: Nonpharmacological Interventions (cont.) Continuous positive airway pressure (CPAP) can be beneficial to increase LVEF and improve functional status in patients with HF and sleep apnea. Cardiac rehabilitation can be useful in clinically stable patients with HF to improve functional capacity, exercise duration, HRQOL, and mortality. I IIa IIb III B I IIa IIb III B Stage C HFrEF – Evidenced based guideline-directed medical therapy: Stage C HF r EF – Evidenced based guideline-directed medical therapy Pharmacological Therapy for Management of Stage C HFrEF: Pharmacological Therapy for Management of Stage C HF r EF Recommendations COR LOE Diuretics Diuretics are recommended in patients with HFrEF with fluid retention I C ACE Inhibitors ACE inhibitors are recommended for all patients with HFrEF I A ARBs ARBs are recommended in patients with HFrEF who are ACE inhibitor intolerant I A ARBs are reasonable as alternatives to ACE inhibitor as first line therapy in HFrEF IIa A The addition of an ARB may be considered in persistently symptomatic patients with HFrEF on GDMT IIb A Routine combined use of an ACE inhibitor, ARB, and aldosterone antagonist is potentially harmful III: Harm C Pharmacological Therapy for Management of Stage C HFrEF (cont.): Pharmacological Therapy for Management of Stage C HF r EF (cont.) Recommendations COR LOE Beta Blockers Use of 1 of the 3 beta blockers proven to reduce mortality is recommended for all stable patients I A Aldosterone Antagonists Aldosterone receptor antagonists are recommended in patients with NYHA class II-IV HF who have LVEF ≤35% I A Aldosterone receptor antagonists are recommended in patients following an acute MI who have LVEF ≤40% with symptoms of HF or DM I B Inappropriate use of aldosterone receptor antagonists may be harmful III: Harm B Hydralazine and Isosorbide Dinitrate The combination of hydralazine and isosorbide dinitrate is recommended for African-Americans, with NYHA class III–IV HFrEF on GDMT I A A combination of hydralazine and isosorbide dinitrate can be useful in patients with HFrEF who cannot be given ACE inhibitors or ARBs IIa B Pharmacologic Therapy for Management of Stage C HFrEF (cont.): Pharmacologic Therapy for Management of Stage C HF r EF (cont.) Recommendations COR LOE Digoxin Digoxin can be beneficial in patients with HFrEF IIa B Anticoagulation Patients with chronic HF with permanent/persistent/paroxysmal AF and an additional risk factor for cardioembolic stroke should receive chronic anticoagulant therapy* I A The selection of an anticoagulant agent should be individualized I C Chronic anticoagulation is reasonable for patients with chronic HF who have permanent/persistent/paroxysmal AF but without an additional risk factor for cardioembolic stroke* IIa B Anticoagulation is not recommended in patients with chronic HFrEF without AF, prior thromboembolic event, or a cardioembolic source III: No Benefit B Statins Statins are not beneficial as adjunctive therapy when prescribed solely for HF III: No Benefit A Omega-3 Fatty Acids Omega-3 PUFA supplementation is reasonable to use as adjunctive therapy in HFrEF or HFpEF patients IIa B Pharmacological Therapy for Management of Stage C HFrEF (cont.): Pharmacological Therapy for Management of Stage C HF r EF (cont.) Recommendations COR LOE Other Drugs Nutritional supplements as treatment for HF are not recommended in HFrEF III: No Benefit B Hormonal therapies other than to replete deficiencies are not recommended in HFrEF III: No Benefit C Drugs known to adversely affect the clinical status of patients with HFrEF are potentially harmful and should be avoided or withdrawn III: Harm B Long-term use of an infusion of a positive inotropic drug is not recommended and may be harmful except as palliation III: Harm C Calcium Channel Blockers Calcium channel blocking drugs are not recommended as routine in HFrEF III: No Benefit A PowerPoint Presentation: Stage D Treatment of Stages A to D Clinical Events and Findings Useful for Identifying Patients With Advanced HF: Clinical Events and Findings Useful for Identifying Patients With Advanced HF Repeated (≥2) hospitalizations or ED visits for HF in the past year Progressive deterioration in renal function (e.g., rise in BUN and creatinine) Weight loss without other cause (e.g., cardiac cachexia) Intolerance to ACE inhibitors due to hypotension and/or worsening renal function Intolerance to beta blockers due to worsening HF or hypotension Frequent systolic blood pressure <90 mm Hg Persistent dyspnea with dressing or bathing requiring rest Inability to walk 1 block on the level ground due to dyspnea or fatigue Recent need to escalate diuretics to maintain volume status, often reaching daily furosemide equivalent dose >160 mg/d and/or use of supplemental metolazone therapy Progressive decline in serum sodium, usually to <133 mEq /L Frequent ICD shocks Adapted from Russell et al. Congest Heart Fail. 2008;14:316-21. Therapies in the Hospitalized HF Patient: Therapies in the Hospitalized HF Patient Recommendation COR LOE HF patients hospitalized with fluid overload should be treated with intravenous diuretics I B HF patients receiving loop diuretic therapy, should receive an initial parenteral dose greater than or equal to their chronic oral daily dose, then should be serially adjusted I B HFrEF patients requiring HF hospitalization on GDMT should continue GDMT unless hemodynamic instability or contraindications I B Initiation of beta-blocker therapy at a low dose is recommended after optimization of volume status and discontinuation of intravenous agents I B Thrombosis/thromboembolism prophylaxis is recommended for patients hospitalized with HF I B Serum electrolytes, urea nitrogen, and creatinine should be measured during the titration of HF medications, including diuretics I C Therapies in the Hospitalized HF Patient (cont.): Therapies in the Hospitalized HF Patient (cont.) Recommendation COR LOE When diuresis is inadequate, it is reasonable to a) Give higher doses of intravenous loop diuretics; or b) add a second diuretic (e.g., thiazide) IIa B B Low-dose dopamine infusion may be considered with loop diuretics to improve diuresis IIb B Ultrafiltration may be considered for patients with obvious volume overload IIb B Ultrafiltration may be considered for patients with refractory congestion IIb C Intravenous nitroglycerin, nitroprusside or nesiritide may be considered an adjuvant to diuretic therapy for stable patients with HF IIb B In patients hospitalized with volume overload and severe hyponatremia , vasopressin antagonists may be considered IIb B PowerPoint Presentation: Recommendations for Inotropic Support, MCS, and Cardiac Transplantation PowerPoint Presentation: Recommendations for Inotropic Support, MCS, and Cardiac Transplantation (contd...) Surgical/Percutaneous/Transcatheter Interventional Treatment of HF: Surgical/Percutaneous/Transcatheter Interventional Treatment of HF Recommendation COR LOE CABG or percutaneous intervention is indicated for HF patients on GDMT with angina and suitable coronary anatomy especially, significant left main stenosis or left main equivalent disease I C CABG to improve survival is reasonable in patients with mild to moderate LV systolic dysfunction and significant multivessel CAD or proximal LAD stenosis when viable myocardium is present IIa B CABG or medical therapy is reasonable to improve morbidity and mortality for patients with severe LV dysfunction (EF <35%), HF and significant CAD IIa B Surgical aortic valve replacement is reasonable for patients with critical aortic stenosis and a predicted surgical mortality of no greater than 10% IIa B Transcatheter aortic valve replacement is reasonable for patients with critical aortic stenosis who are deemed inoperable IIa B CABG may be considered in patients with ischemic heart disease, severe LV systolic dysfunction and suitable coronary anatomy whether or not viable myocardium is present IIb B Transcatheter mitral valve repair or mitral valve surgery for functional mitral insufficiency is of uncertain benefit IIb B Surgical reverse remodeling or LV aneurysmectomy may be considered in HFrEF for specific indications including intractable HF and ventricular arrhythmias IIb B Recommendations for Treatment of HFpEF: Recommendations for Treatment of HF p EF Health Related Quality Of Life (HRQOL) & Functional Status: Health Related Quality Of Life (HRQOL) & Functional Status Heart Failure significantly decreases health related quality of life especially in area of physical functioning & vitality. Lack of improvement in HRQOL is a powerful predictor of re-hospitalization & mortality. Women have consistently been found to have poor HRQOL than men. Pharmacotherapy is not a consistent determinant of HRQOL. ACEI / ARB’s improve HRQOL only modestly or delay the progressive worsening of HRQOL in HF. CRT is only therapy known to improve HRQOL. Management of Heart Failure: Management of Heart Failure A substantial genetic risk exists in some patients for development of HF obtaining a three generation family history of HF is recommended. Many therapeutic agents especially anthracycline based chemotherapeutic agents increases risk of HF. Use of advanced echocardiographic technique & or biomarkers to identify HF risk is needed. Management of Heart Failure (contd…): Management of Heart Failure (contd…) Elevated BP is a major risk factor for development of both HF p EF & HF r EF, a risk that extends across all age groups. Long term treatment of both systolic and diastolic hypertension reduces the risk of incident HF by 50%. Diuretic based antihypertensive therapy has been shown to prevent HF in wide range of patients. Dysglycemia appears to be directly linked to the risk with HbA 1 C concentration powerfully predicting incident HF. Those with HbA 1 C > 10.5% had a nearly 4 fold increase risk of HF compared to those with a value of < 6.5%. Management of Heart Failure (contd…): Management of Heart Failure (contd…) Data on dietary sodium restriction is conflicting. Observational data suggests an association between dietary sodium intake with fluid retention and risk for hospitalization. Other studies have signaled a worsening neurohormonal profile with sodium restriction in HF. 3 RCT that assessed outcomes with sodium restriction have all shown that lower sodium intake is associated with worse outcome in HF r EF (AJC 2009: 103: 93-102, J. CARD Fail 2009: 15; 364) Management of Heart Failure (contd…): Management of Heart Failure (contd…) Sleep disorders are common in patients with HF. About 61% has either central or obstructive sleep apnea. HF patients rarely report daytime sleepiness. High degree of suspicious for sleep disorders should be maintained for this patients. Obesity Paradox – A “U” shaped distribution curve has been suggested in which mortality is greatest in Cachectic patients, lower in normal, over weight & mildly obese patients and higher again in more severely obese patients. Management of Heart Failure (contd…): Management of Heart Failure (contd…) Diuretics are only drugs used for the treatment of HF that can adequately control the fluid retention in HF, however their effect on morbidity and mortality are not known. ACEI can reduce risk of death & reduce hospitalization in HF r EF. The benefits of ACEI are seen in asymptomatic, mild, moderate and severe LV dysfunction and HF i& in patients with and without CAD. ACEI & ARB’s can prevent the development of other risk factor for HF such as renal dysfunction. Management of Heart Failure (contd…): Management of Heart Failure (contd…) ACEI should be prescribed to all patients with HF r EF. Unless contraindication, ACEI are used together with Beta blockers. Available data suggests that there are no difference among available ACEI in their effects on symptom or survival. Abrupt withdrawal of treatment with ACEI can lead to clinical deterioration and should be avoided. Management of Heart Failure – Guideline 2013: Management of Heart Failure – Guideline 2013 Long term treatment with beta blockers can lessen the symptom of HF, improves the clinical status and enhances the patients’ overall sense of well being. Beta blockers reduces the risk of death. Benefits of beta blockers are seen in patients with or without CAD, with or without DM as well as in women and blacks. Beta blockers should be prescribed to an patients with stable HF r EF unless they have a contraindication to their use or are intolerant of these drugs. Management of Heart Failure – Guideline 2013: Management of Heart Failure – Guideline 2013 Patient need not take high dose of ACEI before initiation of beta blocker therapy. In patients taking a low dose of ACEI, the addition of a beta blocker produces a greater improvement in symptom and reduction in the risk of death than does an increase in the dose of ACEI even in target doses used in clincal trials. Beta blockers can be safely started before discharge even in patients hospitalized for HF, provided they do not require IV Inotropic therapy for HF. Management of Heart Failure – Guideline 2013: Management of Heart Failure – Guideline 2013 Three beta blockers (Bisoprolol, sustained release Metoprolol (succinate) & Carvedilol) have been shown to be effective in reducing the risk of death in patients with chronic HFrEF. There is no beta blocker class effect: - Bucindolol lacks uniform effectiveness across different population. - Short acting Metoprolol tart rate less effective in HF clinical trials. - Nebivolol demonstrated modest reduction in primary end points of mortality and hospitalization Management of Heart Failure – Guideline 2013: Management of Heart Failure – Guideline 2013 Up to 30% of patients with CRT fail to experience clinical improvement. There is poor correlation between mechanical & electrical Dyssynchrony. No leading markers such as QRS width, echo parameters assessing Dyssynchrony, scar or lead location has been shown to be fool proof. Electrical Dyssynchrony measured by QRS width remains strongest predictor of response to CRT. QRS narrowing after CRT is not seen in all responders and patients with RBBB do not respond to CRT compared to patients with LBBB. Heart Failure Guidelines 2013: Heart Failure Guidelines 2013 Clinical practice guidelines are systemically developed statements that aim to help Physicians & patients reach the best healthcare decision. Guidelines are not lists of instructions, algorithms or protocols to be followed verbatim. It is not a substitute for astute and conscientious clinical judgment. There is always an element of interpretation and judgment that needs to be exercised when adopting any of the contents into clinical practice. Heart Failure Guidelines 2013 (contd…): Heart Failure Guidelines 2013 (contd…) Major strength being well supported hitherto by good basic science and pathophysiological research, large RCT & meta analysis. Major weakness – Inherent problem in guidelines for translation of research into clinical practice. - Generalizability of trial data - Heterogeneity of response to treatment - Population versus individuals - No evidence of benefit or evidence of no benefit ? Heart Failure Guidelines: Heart Failure Guidelines “Systematically developed statements that aim to help Physician & Patients reach the best healthcare decisions”. Pharmacotherapy for Heart Failure: DIURETICS ACE INHIBITORS ARB’s ALDOSTERONE ANTAGONISTS BETA-BLOCKERS HYDRALAZINE & ISOSORBIDE DINITRATE COMBINATION DIGOXIN IONOTROPES ANTICOAGULATION STATINS OMEGA-3 FATTY ACIDS Pharmacotherapy for Heart Failure (B) Subgroup Analysis of the MERIT-HF study suggesting that compared to the placebo group, the effects of metoprolol were similar amongst patients who received < 100 and > 100 mg once daily of metoprolol succinate. (C) Comparison of mortality on metoprolol tartrate and Carvedilol.: (B) Subgroup Analysis of the MERIT-HF study suggesting that compared to the placebo group, the effects of metoprolol were similar amongst patients who received < 100 and > 100 mg once daily of metoprolol succinate. (C) Comparison of mortality on metoprolol tartrate and Carvedilol. Device Therapy for Stage C HFrEF: Recommendations: Device Therapy for Stage C HF r EF: Recommendations Class I ICD therapy is recommended for primary prevention of SCD to reduce total mortality in selected patients with nonischemic DCM or ischemic heart disease at least 40 days post-MI with LVEF of 35% or less, and NYHA class II or III symptoms on chronic GDMT, who have reasonable expectation of meaningful survival for more than 1 year (Level of Evidence: A) CRT is indicated for patients who have LVEF of 35% or less, sinus rhythm, left bundle-branch block (LBBB) with a QRS duration of 150 ms or greater, and NYHA class II, III, or ambulatory IV symptoms on GDMT (Level of Evidence: A for NYHA Class III / IV; Level of Evidence: B for NYHA class II). ICD therapy is recommended for primary prevention of SCD to reduce total mortality in selected patients at least 40 days post-MI with LVEF of 30% or less and NYHA class I symptoms while receiving GDMT, who have reasonable expectation of meaningful survival for more than 1 year (Level of Evidence B) . Device Therapy for Stage C HFrEF: Recommendations (Contd…): Device Therapy for Stage C HF r EF: Recommendations (Contd…) Class IIa CRT can be useful for patients who have LVEF of 35% or less, sinus rhythm, a non-LBBB pattern with a QRS duration of 150 ms or greater, and NYHA class III/ambulatory class IV symptoms on GDMT (Level of Evidence: A) . CRT can be useful for patients who have LVEF of 35% or less, sinus rhythm, LBBB with a QRS duration of 120 to 149 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT (Level of Evidence B) . Device Therapy for Stage C HFrEF: Recommendations (Contd…): Device Therapy for Stage C HF r EF: Recommendations (Contd…) Class IIa 3. CRT can be useful in patients with AF and LVEF of 35% or less on GDMT if a) the patient requires ventricular pacing or otherwise meets CRT criteria and b) atrioventricular nodal ablation or pharmacological rate control will allow near 100% ventricular pacing with CRT (Level of Evidence: B). 4. CRT can be useful for patients on GDMT who have LVEF of 35% or less, and are undergoing placement of a new or replacement device implantation with anticipated requirement for significant (>40%) ventricular pacing (Level of Evidence: C) . Device Therapy for Stage C HFrEF: Recommendations (Contd…): Device Therapy for Stage C HF r EF: Recommendations (Contd…) Class IIb The usefulness of implantation of an ICD is of uncertain benefit to prolong meaningful survival in patients with a high risk of non sudden death as predicted by frequent hospitalizations, advanced frailty, or co-morbidities such as systemic malignancy or severe renal dysfunction (Level of Evidence: B). CRT may be considered for patients who have LVEF of 35% or less , sinus rhythm, a non-LBBB pattern with a QRS duration of 120 to 149 ms, and NYHA class III / ambulatory class IV on GDMT (Level of Evidence B) . CRT may be considered for patients who have LVEF of 35% or less, sinus rhythm, a non-LBBB pattern with a QRS duration of 150 ms or greater and NYHA class II symptoms on GDMT (Level of Evidence B) Device Therapy for Stage C HFrEF: Recommendations (Contd…): Device Therapy for Stage C HF r EF: Recommendations (Contd…) Class IIb 4. CRT may be considered for patients who have LVEF of 30% or less, ischemic etiology of HF, sinus rhythm, LBBB with a QRS duration of 150 ms or greater, and NYHA class I symptoms on GDMT (Level of Evidence C) . Device Therapy for Stage C HFrEF: Recommendations (Contd…): Device Therapy for Stage C HF r EF: Recommendations (Contd…) Class III: No benefit CRT is not recommended for patients with NYHA class I or II symptoms and non-LBBB pattern with QRS duration less than 150 ms (Level of Evidence: B) CRT is not recommended for patients whose co-morbidities and / or frailty limit survival with good functional capacity to less than 1 year (Level of Evidence: C) ESC Definition of Advanced HF: Severe symptoms of HF with dyspnea and / or fatigue at rest or with minimal exertion (NYHA class III or IV) Episodes of fluid retention (pulmonary and / or systemic congestion, peripheral edema) and / or reduced cardiac output at rest (peripheral hypoperfusion) Objective evidence of severe cardiac dysfunction shown by at least 1 of the following: a) LVEF < 30% b) Pseudonormal or restrictive mitral inflow pattern c) Mean PCWP > 16 mm Hg and / or RAP > 12 mm Hg by PA catheterization d) High BNP or NT-proBNP plasma levels in the absence of non- cardiac causes. ESC Definition of Advanced HF ESC Definition of Advanced HF (contd…): 4. Severe impairment of functional capacity shown by 1 of the following: a) Inability to exercise b) 6-Minute walk distance < 300 m c) Peak Vo 2 < 12 to 14 mL/kg/min History of > 1 HF hospitalization in past 6 months Presence of all the previous features despite “attempts to optimize” therapy, including diuretics and GDMT, unless these are poorly tolerated or contraindicated, and CRT when indicated. ESC Definition of Advanced HF (contd…) PowerPoint Presentation: Recommendations for Therapies in the Hospitalized HF patient PowerPoint Presentation: Recommendations for Therapies in the Hospitalized HF patient ( contd …) PowerPoint Presentation: Recommendations for Surgical / Percutaneous / Transcatheter Interventional Treatments of HF PowerPoint Presentation: Recommendations for Surgical / Percutaneous / Transcatheter Interventional Treatments of HF ( contd …) OMEGA-3 Fatty Acid in Heart Failure: OMEGA-3 Fatty Acid in Heart Failure Tavazzi L, Maggioni AP, Marchioli R, et al. Effect of n-3 poly-unsaturated fatty acids in patients with chronic heart failure (the GISSI-HF trial): a radomized, double-blind, placebo-controlled trial. Lancet 2008: 372: 1223 – 30. Lavie CJ, Milani RV, Mehra MR, et al. Omega-3 polyunsaturated fatty acids and cardiovascular diseases. J Am Coll Cardiol 2009: 54: 585-94 OMEGA-3 Fatty Acid in Heart Failure (contd…): OMEGA-3 Fatty Acid in Heart Failure (contd…) Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto mio-cardico. Dietary supplementation with n-3 polyunsaturated fatty acids and Vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Lancet 1999; 354:447-55. Nodari S, Triggiani M, Campia U, et al. Effects of n-3 polyunsaturated fatty acids on left ventricular function and functional capacity in patients with dilated cardiomyopathy. J Am Coll Cardiol 2011; 57: 870-9. Statins in Heart Failure: Statins in Heart Failure Kjekshus J. Apetrei E. Barrios V, et al. Rosuvastatin in older patients with systolic heart failure. N Engl J Med 2007: 357: 2248 – 61 . Tavazzi L, Maggioni AP, Marchioli R, et al. Effect of rosuvastatin in patients with chronic heart failure (the GISSI – HF trial): a randomized, double-blind, placebo-controlled trial. Lancet 2008: 372: 1231 – 9. Omega-3 Fatty Acids: Recommendation: Omega-3 Fatty Acids: Recommendation Class IIa Omega-3 polyunsaturated fatty acid (PUFA) supplementation is reasonable to use as adjunctive therapy in patients with NYHA class II-IV symptoms and HF r EF or HF p EF , unless contraindicated, to reduce mortality and cardiovascular hospitalizations (Level of Evidence: B) Statins: Recommendation: Statins: Recommendation Class III: No benefit Statins are not beneficial as adjunctive therapy when prescribed solely for the diagnosis of HF in the absence of other indications for their use (Level of Evidence: A) Anticoagulation : Recommendation: Anticoagulation : Recommendation Class I Patients with chronic HF with permanent / persistent / paroxysmal AF and an additional risk factor for cardioembolic stroke (history of hypertension, diabetes mellitus, previous stroke or transient ischemic attack, or > 75 years of age) should receive chronic anticoagulant therapy (Level of Evidence: A) The selection of an anticoagulant agent ( warfarin , dabigatran , apixaban , or rivaroxaban ) for permanent / persistent / paroxysmal AF should be individualized on the basis of risk factors, cost, tolerability, patient preference, potential for drug interactions, and other clinical characteristics, including time in the international normalized ratio therapeutic range if the patient has been taking warfarin (Level of Evidence: C) Anticoagulation : Recommendation (Contd…): Anticoagulation : Recommendation (Contd…) Class IIa Chronic anticoagulation is reasonable for patients with chronic HF who have permanent / persistent / paroxysmal AF but are without an additional risk factor for cardioembolic stroke (Level of Evidence: B) Class III: No benefit Anticoagulation is not recommended in patients with chronic HF r EF without AF, a prior thromboembolic event, or a cardioembolic source (Level of Evidence: B) Venous Thrombo embolism Prophylaxis in Hospitalized Patients: Recommendation: Class I A patient admitted to the hospital with de-compensated HF should receive venous thromboembolism prophylaxis with an anticoagulant medication if the risk-benefit ratio is favourable (Level of Evidence: B) . Venous Thrombo embolism Prophylaxis in Hospitalized Patients: Recommendation Treatment of Sleep Disorders: Recommendation: Treatment of Sleep Disorders: Recommendation Class IIa Continuous positive airway pressure can be beneficial to increase LVEF and improve functional status in patients with HF and sleep apnea (Level of Evidence: B) Stages, Phenotypes and Treatment of HF: Stages, Phenotypes and Treatment of HF PowerPoint Presentation: Treatment of Stages A to D Guideline for HF PowerPoint Presentation: Stage C Treatment of Stages A to D PowerPoint Presentation: Pharmacological Treatment for Stage C HF r EF Treatment of Stages A to D Pharmacological Treatment for Stage C HFrEF (cont.): Pharmacological Treatment for Stage C HF r EF (cont.) Aldosterone receptor antagonists [or mineralocorticoid receptor antagonists (MRA)] are recommended in patients with NYHA class II-IV and who have LVEF of 35% or less, unless contraindicated, to reduce morbidity and mortality. Patients with NYHA class II should have a history of prior cardiovascular hospitalization or elevated plasma natriuretic peptide levels to be considered for aldosterone receptor antagonists. Creatinine should be 2.5 mg/dL or less in men or 2.0 mg/dL or less in women (or estimated glomerular filtration rate >30 mL/min/1.73m2) and potassium should be less than 5.0 mEq/L. Careful monitoring of potassium, renal function, and diuretic dosing should be performed at initiation and closely followed thereafter to minimize risk of hyperkalemia and renal insufficiency. I IIa IIb III A Pharmacological Treatment for Stage C HFrEF (cont.): Pharmacological Treatment for Stage C HF r EF (cont.) Aldosterone receptor antagonists are recommended to reduce morbidity and mortality following an acute MI in patients who have LVEF of 40% or less who develop symptoms of HF or who have a history of diabetes mellitus, unless contraindicated. Inappropriate use of aldosterone receptor antagonists is potentially harmful because of life-threatening hyperkalemia or renal insufficiency when serum creatinine greater than 2.5 mg/dL in men or greater than 2.0 mg/dL in women (or estimated glomerular filtration rate <30 mL/min/1.73m2), and/or potassium above 5.0 mEq/L. I IIa IIb III B I IIa IIb III B Harm Pharmacological Treatment for Stage C HFrEF (cont.): Pharmacological Treatment for Stage C HF r EF (cont.) The combination of hydralazine and isosorbide dinitrate is recommended to reduce morbidity and mortality for patients self-described as African Americans with NYHA class III–IV HF r EF receiving optimal therapy with ACE inhibitors and beta blockers, unless contraindicated. A combination of hydralazine and isosorbide dinitrate can be useful to reduce morbidity or mortality in patients with current or prior symptomatic HF r EF who cannot be given an ACE inhibitor or ARB because of drug intolerance, hypotension, or renal insufficiency, unless contraindicated. I IIa IIb III A I IIa IIb III B Pharmacological Treatment for Stage C HFrEF (cont.): Pharmacological Treatment for Stage C HF r EF (cont.) Digoxin can be beneficial in patients with HF r EF, unless contraindicated, to decrease hospitalizations for HF. Patients with chronic HF with permanent/persistent/ paroxysmal AF and an additional risk factor for cardioembolic stroke (history of hypertension, diabetes mellitus, previous stroke or transient ischemic attack, or ≥75 years of age) should receive chronic anticoagulant therapy (in the absence of contraindications to anticoagulation). I IIa IIb III B I IIa IIb III A Pharmacological Treatment for Stage C HFrEF (cont.): Pharmacological Treatment for Stage C HF r EF (cont.) The selection of an anticoagulant agent (warfarin, dabigatran, apixaban, or rivaroxaban) for permanent/persistent/paroxysmal AF should be individualized on the basis of risk factors, cost, tolerability, patient preference, potential for drug interactions, and other clinical characteristics, including time in the international normalized rate therapeutic ration if the patient has been taking warfarin. Chronic anticoagulation is reasonable for patients with chronic HF who have permanent/persistent/paroxysmal AF but are without an additional risk factor for cardioembolic stroke (in the absence of contraindications to anticoagulation). I IIa IIb III I IIa IIb III B Pharmacological Treatment for Stage C HFrEF (cont.): Pharmacological Treatment for Stage C HF r EF (cont.) Anticoagulation is not recommended in patients with chronic HF r EF without AF, a prior thromboembolic event, or a cardioembolic source. Statins are not beneficial as adjunctive therapy when prescribed solely for the diagnosis of HF in the absence of other indications for their use. Omega-3 polyunsaturated fatty acid (PUFA) supplementation is reasonable to use as adjunctive therapy in patients with NYHA class II-IV symptoms and HF r EF or HF p EF, unless contraindicated, to reduce mortality and cardiovascular hospitalizations. I IIa IIb III B No Benefit I IIa IIb III A No Benefit I IIa IIb III B Pharmacological Treatment for Stage C HFrEF (cont.): Pharmacological Treatment for Stage C HF r EF (cont.) Nutritional supplements as treatment for HF are not recommended in patients with current or prior symptoms of HFrEF. Hormonal therapies other than to correct deficiencies are not recommended for patients with current or prior symptoms of HF r EF. Drugs known to adversely affect the clinical status of patients with current or prior symptoms of HF r EF are potentially harmful and should be avoided or withdrawn whenever possible (e.g., most antiarrhythmic drugs, most calcium channel blocking drugs (except amlodipine), NSAIDs, or TZDs). No Benefit I IIa IIb III B I IIa IIb III I IIa IIb III B No Benefit Harm Pharmacological Treatment for Stage C HFrEF (cont.): Pharmacological Treatment for Stage C HF r EF (cont.) Long-term use of infused positive inotropic drugs is potentially harmful for patients with HF r EF, except as palliation for patients with end-stage disease who cannot be stabilized with standard medical treatment (see recommendations for stage D). Calcium channel blocking drugs are not recommended as routine treatment for patients with HF r EF. Harm I IIa IIb III I IIa IIb III A No Benefit Arginine Vasopressin Antagonists: Arginine Vasopressin Antagonists In patients hospitalized with volume overload, including HF, who have persistent severe hyponatremia and are at risk for or having active cognitive symptoms despite water restriction and maximization of GDMT, vasopressin antagonists may be considered in the short term to improve serum sodium concentration in hypervolemic, hyponatremic states with either a V2 receptor selective or a nonselective vasopressin antagonist. I IIa IIb III B 2013 Guidelines for cardiac resynchronization therapy in patients with systolic heart failure : 2013 Guidelines for cardiac resynchronization therapy in patients with systolic heart failure Recommendations Selection Criteria Class I EF < 35%, QRS > 120 ms, optimal medical management SR NYHA class III – IV Class II a Same AF or frequent VP Same Class II b Same SR, AF, Frequent VP NYHA class I – II Class III (cardiac resynchronization therapy not recommended) Asymptomatic patients with reduced EF in the absence of other indications for pacing or in patients whose life expectancy and functional status are limited by non-cardiac conditions

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