Heart Failure Overview Dr Chris K Y Wong
Heart Failure: A Growing, Global Health Issue
Heart Failure 23 Million Afflicted Global Impact Worldwide ~23 million peopleworldwide afflicted with CHF 1 Exceeds the total population of Australia at 21.8 million people 2 1 www.marketresearch.com; CHF: worldwide drug and medical device markets 2 www.wikipedia; Australia; 2009 population estimate
Heart Failure: A Growing, Global Health Issue 2 million new cases diagnosed worldwide each year 1 Incident rate continues to rise; HF is the most rapidly growing CV disorder in the US 1 HF currently affects 2% to 2.5% of adults in the US, UK and Western countries 2 1 www.marketresearch.com; CHF: worldwide drug and medical device markets 2 Populations for CRT Devices; HRS journal 2009; article at press
Heart Failure in the US 5.7 Million US Impact and Growing Prevalence = 5.7 million Americans 1, or the approximate total population of the Houston, TX metro area 2 Houston, Texas USA 1 AHA Heart Disease and Stroke Statistics 2009 Update 2 http://www.getlisty.com/preview/us-metros-with-largest-population-growth-2007-2008/
US Heart Failure: Single Most Important CV Health Burden Incidence rate approaches 10 per 1,000 population after age 65 At age 40, lifetime risk of developing HF = 1 in 5 Mortality rate at 5 years = 50% Single most important CV public health burden Estimated direct/indirect costs in US for 2009 = $37.2 billion More than 1 million hospital discharges for HF in 2006 AHA Heart Disease and Stroke Statistics 2009 Update
Heart Failure Classification NYHA Functional & ACC/AHA Stages
NYHA Functional Classification Class Patient Symptoms Class I (Mild) No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea. Class II (Mild) Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. Class III (Moderate) Class IV (Severe) Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. HFSA; www.abouthf.org
ACC/AHA Stages of HF Stage Description Examples A B C D Patients at high risk of developing HF; no identified structural or functional abnormalities of the pericardium, myocardium or cardiac valves and have never shown signs or symptoms of HF Patients who have developed structural heart disease that is strongly associated with the development of HF but who have never shown signs or symptoms Patients who have current or prior symptoms of HF associated with underlying structural heart disease Patients with advanced structural heart disease and marked symptoms of HF at rest despite maximal medical therapy; require specialized interventions Systemic hypertension CAD Diabetes mellitus Family history of cardiomyopathy Previous MI LV systolic dysfunction Asymptomatic valvular disease Shortness of breath and fatigue due to LV systolic dysfunction Asymptomatic pts who are undergoing treatment for prior HF symptoms Pts frequently hospitalized for HF Pts awaiting heart transplant 2009 Focused Update: ACCF/AHA Guidelines for the Diagnosis and Management of HF in Adults Circulation 2009;119;1977-2016; originally published online Mar 26, 2009;
Device-Based Therapy of Cardiac Rhythm Abnormalities ACC/AHA/HRS & ESC 2008 Guidelines
What: Why: When: Where: The ACC/AHA/HRS released new guidelines that combine indications for all cardiac implantable electronic devices (pacemaker/icd/crt). The guidelines were updated to incorporate data from recent clinical trials & therapy advances. The guidelines are effective immediately. They are an update to 2002 guidelines & compliment 2006 ACC/AHA/ESC recommendations. More information is available through the American Heart Association: http://www.americanheart.org/presenter.jhtml?identifier=3004542 ACC or HRS.
ACC/AHA/HRS Recommendations for CRT Implantation Class I: LVEF 35%, QRS 0.12 seconds, NYHA III or ambulatory IV and sinus rhythm Class IIa: LVEF 35%, QRS 0.12 seconds, NYHA functional Class III or ambulatory IV and AF LVEF 35%, NYHA functional Class III & ambulatory IV symptoms and frequent dependence on ventricular pacing. JACC vol 51, No21, 2008, MAY 27, 2008
ESC Guidelines for Device Therapy Treatment www.escardio.org/guidelines-surveys/esc- guidelines/guidelinesdocuments/guidelines-hf-slides- 2008.pdf
Heart Failure Definition and Classification Heart Failure (HF) definition Inability of the heart to provide enough oxygenated blood flow to meet the body s metabolic demand Classification Systolic Diastolic
Heart Failure Definition and Classification Systolic Dysfunction Impaired ventricular contraction (systole) LVEF < 0.45 Contributing factors Increased intravascular resistance (increased after load). Valvular heart disease Mitral regurgitation Aortic stenosis Aortic insufficiency
Heart Failure Definition and Classification Diastolic Dysfunction Inability of the ventricles to fill or relax during diastole. Associated with conditions that increase left ventricular stiffness: Concentric hypertrophy Infiltrative cardiomyopathy Acute ischemia It is possible for a patient to have both systolic and diastolic dysfunction.
Mortality of Heart Failure 50% Years after hospitalization for HF Heart Failure Incidence and Survival (from the Atherosclerosis Risk in Communities Study) (Am J Cardiol 2008;101:1016 1022) 17
Etiology of Heart Failure Etiology Etiologies of Congestive Heart Failure Patients, Nonischemic Disease with n(%) Etiology, % Ischemic 936(50.3) Nonischemic 925(49.7) No etiology provided 247(13.3) Etiology provided 678(36.4) Idiopathic 340(18.2) 50.1 Valvular 75(4.0) 11.1 Hypertensive 70(3.8) 10.3 Ethanol 34(1.8) 5.0 Viral 9(0.4) 1.3 Postpartum 8(0.4) 1.2 Amyloidosis 1(0.1) 0.1 Other/unspecified 141(7.6) 20.8 18
Coronary Artery Disease Residual damageto the left ventricle results in abnormal muscle functionand again affects the contractile ability of the heart. 19
Cardiomyopathy 20
Aortic valve stenosisand insufficiency 21
HOCM 22
Symptoms of Heart Failure Dyspnea Fatigue Limit exercise tolerance Fluid retention Pulmonary congestion Peripheral oedema Tachycardia Hepatomegaly Elevated jugular pressure Anorexia 23
Symptoms of Heart Failure Pitting oedema 24
Heart Failure Consequences Systolic or Diastolic Dysfunction Increase in left ventricular diastolic pressure which leads to: Elevated pressure in left atrium and lungs Pulmonary congestion Decreased cardiac output Symptoms Congestion Dyspnea Edema Low Output Fatigue Cool extremities Mental status changes
Heart Failure Definition and Classification Systolic vs. Diastolic Dysfunction Characteristic Systolic HF Diastolic HF Size of LV Dilated Normal LV Systolic Function Impaired Normal/hyperdynamic LV Wall Thickness Normal Thick LV Wall Motion Reduced Normal Coronary Artery Disease More Likely Less Likely Non-ischemic Cardiomyopathy % of HF Patients with each type of disorder Less Likely More Likely 60 80% 20 40%
Treatment Objectives and Options Treatment objectives: Treat the underlying cause Improve symptoms Improve quality of life Decrease the likelihood of disease progression Treatment options: Non - Pharmacologic Pharmacologic Device Therapy
Treatment Objectives and Options Non-Pharmacologic Treatment Options Patient and family education Recognizing symptoms Understanding treatment options Ensuring treatment compliance Dietary modifications Optimize sodium intake Limiting alcohol and fluid intake Weight reduction Lifestyle modifications Rest and exercise considerations Travel Smoking cessation
Treatment Objectives and Options Pharmacologic Most frequently used therapy for HF. Optimized drug therapy is an essential part of any treatment plan. Commonly prescribed HF medications: Diuretics Beta-adrenergic receptor blockers (betablockers) Angiotensin converting-enzyme inhibitors (ACE inhibitors) Digoxin Vasodialators Anti-Arrhythmics
ICD Therapy Treatment Objectives and Options Device Therapy HF increases the risk for Sudden Cardiac Arrest occurs by 6-9 times. CRT Therapy Adjunctive therapy to pharmacological treatment in pts with HF and prolonged QRS. 30 50% of patients have intra-ventricular conduction delays which contribute to abnormal ventricular contraction. A widened QRS complex usually identifies an intraventricular conduction delay. Uses pacing to resynchronize the ventricular contractions to achieve more effective forward flow. Can include defibrillation therapy (CRT-D) to protect against SCA. Widened QRS
CRT Clinical Trials: What have we learned?
CRT Trials: Past, Present & Future CONTAK CD INSYNC ICD MIRACLE(Multicenter In Sync Randomized Clinical Evaluation) COMPANION(Comparison of Medical Therapy, Pacing, and Defibrillation in Chronic Heart Failure) CARE-HF(Cardiac Resynchronization in Heart Failure Study) RHYTHM ICD(Resynchronization for Hemodynamic Treatment for Heart Failure Management) PAVE (LV Based Cardiac Stimulation Post AV Nodal Ablation Evaluation) REVERSE(Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) MADIT-CRT (Multicenter Automatic Defibrillator Implantation with Cardiac Resynchronization Therapy) RAFT (Resynchronization/Defibrillation for Ambulatory Heart Failure) 2002 thru 2010 32
CONTAK CD CRT Trials Overview Overview: Designed to evaluate if biventricular pacing therapy resulted in improvement of HF status in patients indicated for an ICD. Results: Study failed to demonstrate effectiveness of the CRT function of the device when looking at all-cause mortality, hospitalizations for HF and VT/VF events requiring therapy NYHA II/III/IV patient population: 15% NYHA III/IV subgroup: 22% Study Details: Completed in 2001 Prospective randomized multi-center study where patients had to have indication for an ICD and NYHA Class II, III or IV HF despite optimal drug therapy (must include ACE inhibitors if tolerated), a LVEF 35% and a QRS 120 ms Significance: Subgroup analysis revealed a population of patients that had Class III/IV HF at the time of randomization that appeared to have improvements of certain functional endpoints, including the peak VO2 and the 6 minute hall walk. 33
INSYNC ICD CRT Trials Overview Overview: Investigated the effectiveness of biventricular pacingand defibrillation therapy on patients suffering from HF and who were at risk for sudden death. Results: Results were not impressive and yielded a statistical significance only in one of three primary endpoints, that being the improvement in the QOL score. Study Details: Completed in Randomized high voltage CRT study for patients indicated for an ICD and have NYHA Class II, III or IV HF while on a stable drug regimen including ACE inhibitors and beta blockers, a LVEF 35% and a QRS width 130 ms and LVEDD 55 mm Significance: Despite trial results, the FDA did approve the In Sync ICD for treatment of NYHA Class III and IV HF patients who are also indicated for an ICD. 34
CRT Trial Overview MIRACLE(Multicenter In Sync Randomized Clinical Evaluation) Overview: Designed to evaluate the efficacy and safety of combined CRT for patients with NYHA III or IV HF. Results: CRT significantly improved quality of life, functional class, exercise capacity, cardiac function and structure (optimized AV delay caused significant reverse remodeling). 68% of CRT patients improved by one or more functional classes comparedwith 38% of control patients (p<0.001) Study Details: Completed in 2000; 571 patients, 45 centers in the US and Canada NYHA class III or IV HF, LVEF 35%, LVEDD 55 mm, QRS 130 ms, OPT 1 mo. Randomized patients to either CRT ON or CRT Off Significance: A key study, along with the Contak CD and In Sync ICD studies, that lead to the use of CRT devices for HF treatment. 35
CRT Trial Overview COMPANION (Comparison of Medical Therapy, Pacing, and Defibrillation in Chronic Heart Failure) Overview: Conducted to determine if the implantation of a of a low or high voltage device could help achieve resynchronization therapy in patients not indicated for either device. Results: Demonstrated that CRT and CRT-D devices reduced morbidity and mortality in the most symptomatic HF patients. Study Details: Completed in 2002 Enrolled over 1,500 patients with class III or IV HF, LVEF 35%, QRS 120ms, and PR interval > 150ms Patient were randomized 1:2:2 ratio to OPT, OPT +CRT, or OPT +CRTD Significance: This was the first large, randomized study of CRT evaluating the composite of mortality and hospitalization. CRT-P and CRT-D, in combination with OPT, reduced the risk of all-cause mortality or first hospitalization by 19% and 20% respectively vs. OPT alone. The CRTD arm had a 36% reduction on all cause mortality compared to the OPT arm. 36
CRT Trial Overview CARE-HF (Cardiac Resynchronization in Heart Failure Study) Overview: Studied the effects of CRT-only (no defibrillation capability) on morbidity and mortality. Results: 36% reduction in all cause mortality and 52% reduction in unplanned cardiovascular hospitalizations in the CRT arm Study Details: Completed in 2003 Enrolled patients with Class III or IV HF, LVEF 35%, and QRS 120ms. Patients were randomized to either receive CRT and Optimal Medical Therapy, or OMT and no CRT Significance: Established the morbidity and mortality benefits of CRT therapy alone. CRT without defibrillation reduced mortality. 37
CRT Trial Overview RHYTHM ICD (Resynchronization for Hemodynamic Treatment for Heart Failure Management) Overview: A prospective, blinded, randomized controlled study examining if BiV pacing improves cardiac function in ICDindicated patients with HF and an interventricular conduction delay. Designed to examine resynchronization efficacy using Peak VO2 and to establish safety of the Epic TM HF device & Aescula and QuickSite leads Results: There was statistical improvement in Peak VO2, NYHA class, and QoL in the CRT ON vs. OFF group and a trend toward significance in the 6 minute walk. Study Details: Completed in 2003 Prospective, randomized blinded controlled study that enrolled patients with Class III or IV HF, LVEF 35%, and QRS 150ms. Patients randomized 2:1 to ON or OFF. Significance: This SJM study added to the growing body of evidence supporting the therapeutic effectiveness of CRT as a therapy for HF patients. CRT ON Follow-up 1, 3, 6 Months Follow-up Every 3 Months to study completion Standard ICD Indication Heart Failure NYHA Class III or IV Screening Evaluations LV Lead ICD System Implant Baseline Evaluation 14 days post implant Randomization (stratified by HF etiology) 2:1 CRT OFF Follow-up 1, 3, 6 Months Crossover permitted to CRT ON after completing 6-Month Visit 38
Question: Which is not a symptom of heart failure 1. Dyspnoa 2. Odema 3. Arrhythmia 4. Constipation 5. Sudden death 39
Question: CRT can be used in the following 1. Heart Failure 2. Bundle Branch Block (Asynchrony) 3. Long PR 4. None of the above 5. All of the above 40
Thank You! 41