Cardiology Education FINALSCA

Slide 1: 

Increasing Survival in Sudden Cardiac Arrest (SCA): The Role of ICD Therapy

Objectives : 

Objectives Upon completion of this activity, participants will be able to: Describe current trends in the epidemiology and etiology of sudden cardiac arrest (SCA). Assess the risk of SCA in ischemic and non-ischemic populations, including post-MI patients and HF patients. Describe the current evidence underlying the most recent ACC/AHA/ESC guidelines (2006) for the use of ICDs in patients at risk of SCA, and apply those guidelines. List risk-assessment tools being used in clinical practice or under investigation, and describe the current evidence for each. Describe the current CMS coverage for use of ICDs in patients at risk of SCA, and compare the economics of such use to other medical interventions. Assess their current use of ICDs in patients at risk for SCA.

Patient Case : 

Patient Case History 76-y.o. white male Type II DM, low-grade renal dysfunction; both well-controlled 3 years post-MI, successfully revascularized NYHA functional class II; stable LVEF is 32% (echo) Compliant with meds: antiplatelet, beta-blocker, ACE-I, statin, DM regimen

Patient Case : 

Patient Case Clinical Decisions Should this patient be referred for an ICD evaluation? What factors enter into your decision? Is there anything else you'd want to know before making the decision?

AGENDA : 

AGENDA Epidemiology and Etiology Secondary Prevention Primary Prevention Beyond EF: Microvolt T-wave Alternans The Economics of ICDs Implications for Real-World Practice ICD Treatment Algorithms Summary

Slide 6: 

Epidemiology and Etiology

Slide 7: 

Cardiovascular Disease Mortality Trends for Males and Females: United States: 1979-2003* Heart Disease and Stroke Statistics — 2006 Update. CDC/NCHS. * Preliminary. AHA. www.americanheart.org State-Specific Mortality from Sudden Cardiac Death. www.cdc.gov

Slide 8: 

SCA Mortality Trends Age-adjusted cardiovascular deaths have declined; however mortality due to Sudden Cardiac Death has not. Over 60% of coronary artery deaths are attributable to sudden cardiac arrest Goraya TY, et al. Am J Epidemiol. 2003; 157:763-770. Centers for Disease Control. 1999. MMWR Morb Mortal Wkly Rep 2002; 57: 123-126

Leading Causes of Death in the US : 

Leading Causes of Death in the US National Vital Statistics Report. 2001;49;11. MMWR. 2002;51:123-126. Sudden Cardiac Arrest (SCA) 0% 5% 10% 15% 20% 25% Septicemia Nephritis Alzheimer’s Disease Influenza/Pneumonia Diabetes Accidents/Injuries Chronic Lower Respiratory Diseases Cerebrovascular Disease Other Cardiac Causes All Cancers SCA is a leading cause of death in the U.S., second to all cancers combined.

SCA Survival & Mortality Data : 

SCA Survival & Mortality Data At least 335,000 SCA deaths in the U.S. each year Only 5 to 10% survive first episode of SCA Roughly two-thirds of SCA deaths occur out-of-hospital Seidl K, Senges J. Card Electrophysiol Rev. 2003;7:5-13. Heart Disease and Stroke Statistics — 2005 Update. AHA. www.americanheart.org Crespo EM, Kim J, Selzman KA. Am J Med Sci. 2005;329:238-246. Zheng ZJ, et al. Circulation. 2001;104:2158-2163. Zipes, DP, et al. 2006 ACC/AHA/ESC Practice Guidelines 5. Circulation. 2006;114;385-484.

Slide 11: 

Secondary Prevention ofSudden Cardiac Arrest

Patient Case : 

Patient Case History 54-y.o. African-American female Ischemic cardiomyopathy NYHA functional class I LVEF = 28% per echo at your institution Long-time heavy smoker; has COPD Compliant and stable on optimal medical therapy Syncopal episodes

Patient Case : 

Patient Case Clinical Decisions Should this patient be referred for an ICD evaluation? What factors enter into your decision? Is there anything else you'd want to know before making the decision?

Key Randomized Clinical Trials : 

Key Randomized Clinical Trials Adapted from: DiMarco JP. N Engl J Med. 2003;349:1836-47. www.medscape.com Young JB. Sudden cardiac death in heart failure. www.medscape.com ICD therapy for the secondary prevention of SCA

2006 ACC/AHA/ESC Guidelines for the Management of Ventricular Arrhythmias: Secondary Prevention of SCD : 

2006 ACC/AHA/ESC Guidelines for the Management of Ventricular Arrhythmias: Secondary Prevention of SCD ICD Class I Recommendation: Patients with a history of SCA, VF, hemodynamically unstable VT, or unexplained syncope Zipes, DP, et al. 2006 ACC/AHA/ESC Practice Guidelines 5. Circulation. 2006;114;385-484

Slide 16: 

Myerburg RJ, et al. Circulation. 1998. 97:1514-1521. Patients with a previous cardiac arrest are at high risk for subsequent SCA events but account for a small percentage of annual sudden deaths

Slide 17: 

Primary Prevention of Sudden Cardiac Arrest

Patient Case : 

Patient Case History 52 year old woman Moderate alcohol consumption, has stopped since MI Lives alone in rural community; manages on-line content for a large dog food manufacturer PMHX: MI 1 year ago, echo on discharge was 35% Medications: BB, ACE-I, lipid-lowering agent, clopidorgrel, omega-3

Patient Case : 

Patient Case Clinical Decisions Should this patient be referred for an ICD evaluation? What factors enter into your decision? Is there anything else you'd want to know before making the decision?

SCA Relationship to MI : 

SCA Relationship to MI A previous MI can be identified in as many as 75% of SCA patients. A previous MI as a single risk-factor raises the one-year risk of SCA by 5%. The five-year risk of SCA is 32% for patients with all of these risk-factors: history of MI non-sustained, inducible, non-suppressible VT LVEF ≤ 40% Sudden Cardiac Arrest Fast Facts. HRS. www.hrsonline.org Risk factors for sudden cardiac death. www.heartinstitute.org.au/Community/scdMain.asp Buxton AE, et al. N Engl J Med. 1999;341:1882-1890.

Time Dependence of Mortality Risk Post-MIPrediction of Sudden Cardiac Death After Myocardial Infarction in the Beta-Blocking Era1 : 

Time Dependence of Mortality Risk Post-MIPrediction of Sudden Cardiac Death After Myocardial Infarction in the Beta-Blocking Era1 700 post-MI patients; ~ 95% on beta-blockers 2 years after discharge. The epidemiologic pattern of SCD was different from that reported in previous studies. Arrhythmia events did not concentrate early after the index event; most occurred > 18 months post-MI. 1 Huikuri HV. J Am Coll Cardiol. 2003;42:652-658. TotalMortality CardiacMortality Non-SCD SCD Cumulative Events (%) 18 15 12 9 6 3 18 15 12 9 6 3 20 40 60 20 40 60 Follow-Up (months) Follow-Up (months)

Slide 22: 

(n = 300) (n = 283) (n = 284) (n = 292) Hazard Ratio .98 (p = 0.92) 0.52 (p = 0.07) 0.50 (p = 0.02) 0.62 (p = 0.09) Wilber, D. Circulation. 2004;109:1082-1084. Relation of Time from MI to ICD Benefitin the MADIT-II Trial Time from MI % Mortality for Each Time Period

SCA Relationship to HF : 

SCA Relationship to HF Patients with HF are overall at 6-9 times higher risk for SCD than general population As HF progresses, pump failure (rather than SCA) becomes relatively more likely as the cause of death Heart Disease and Stroke Statistics – 2005 Update. AHA. www. americanheart.org

Severity of Heart FailureModes of Death : 

Severity of Heart FailureModes of Death MERIT-HF Study Group. Lancet.1999;353:2001-2007.

SCA Relation to LVEF : 

SCA Relation to LVEF Gorgels PMA. European Heart Journal. 2003;24:1204-1209. LVEF % SCA Victims 7.5% 5.1% 2.8% 1.4% EF is an Important Risk Stratifier

Key Randomized Clinical Trials : 

Key Randomized Clinical Trials Adapted from: DiMarco JP. N Engl J Med. 2003;349:1836-47. www.medscape.comKadish A, et.al. N Engl J Med 2004;350:2151-8.Young JB. Sudden cardiac death in heart failure. www.medscape.com ICD therapy for the primary prevention of SCA

Slide 27: 

Myerburg RJ, et al. Circulation. 1998. 97:1514-1521. Heart Failure and Left Ventricular Dysfunction are indicators of SCA risk

2006 ACC/AHA/ESC Guidelines for the Management of Ventricular Arrhythmias: Primary Prevention of SCD : 

2006 ACC/AHA/ESC Guidelines for the Management of Ventricular Arrhythmias: Primary Prevention of SCD ICD Class I Recommendations: Patients with ischemic cardiomyopathy who are at least 40 days post-MI with an LVEF ≤ 30 - 40% and NYHA functional class II or III Patients with NYHA Class II-III, LVEF ≤ 30 - 35%, non-ischemic cardiomyopathy Patients who are at high risk of SCA due to genetic disorders such as long QT syndrome, Brugada syndrome, hypertrophic cardiomyopathy and arrhythmogenic right ventricular dysplagia (ARVD). ICD Class II Recommendation: Ischemic and non-ischemic patients with NYHA functional class I, LVEF ≤ 30-35% Zipes, DP, et al. 2006 ACC/AHA/ESC Practice Guidelines 5. Circulation. 2006;114;385-484

Current CMS ICD Coverage* : 

Current CMS ICD Coverage* In brief, this policy expands coverage for: 1) Patients with ischemic dilated cardiomyopathy (IDCM), prior MI, NYHA Class II & III heart failure, LVEF less than or equal to 35% 2) Patients with non-ischemic dilated cardiomyopathy (NIDCM) > 3 months, NYHA Class II & III heart failure, LVEF less than or equal to 35% Overall, this NCD covers the SCD-HeFT population and all the MADIT II population. * ICD coverage expanded in January 2005 and updated in April 2006.

Discussion: ICD Contraindications : 

Discussion: ICD Contraindications Standard Contraindications for ICD Therapy Hospitalized patients with advanced age Advanced (NYHA class IV) HF and limited life expectancy Patients whose VT’s may have transient or reversible causes Patients with incessant VT or VF Patients who have a unipolar pacemaker Questions Are there patients who are indicated but who should not get an ICD? Who makes the decision on whether or not an ICD is offered?

Slide 31: 

Beyond EF

Microvolt T-Wave Alternans : 

Microvolt T-Wave Alternans Noninvasive, ECG-based test HR elevation by exercise, atrial pacing, or dobutamine infusion Measures beat-to-beat microvolt variations in the shape, amplitude, or timing of the ECG T-wave

Microvolt T-Wave Alternans : 

Microvolt T-Wave Alternans Sometimes used as a risk-stratification tool Negative result may suggest low risk of SCA High negative-predictive value, low positive-predictive value CMS has approved Medicare coverage when spectral-analytic method used Microvolt T-wave alternans has received a Class IIa recommendation in the 2006 ACC/AHA/ESC Guidelines The guidelines do not state that an ICD is not recommended if the T-wave test is negative. The outcome of the test also does not change the indication for ICD. Bloomfield DM, et al. J Am Coll Cardiol. 2006:47:456-463 Gehi AK, et al. J Am Coll Cardiol. 2005:46(1):75-82 Zipes, DP, et al. 2006 ACC/AHA/ESC Practice Guidelines 5. Circulation. 2006;114;385-484 CMS: Decision Memorandum for Microvolt T-wave Alternans Testing. www.cms.hhs.gov

Microvolt T-Wave Alternans: Issues : 

Microvolt T-Wave Alternans: Issues Patients must be in sinus rhythm (but up to 30% of patients at risk have AF) A patient must sustain a heart rate of 105 for 10 minutes, which may be difficult for patients on beta-blockers. Can be indeterminate Non-sustained MTWA in up to 10% of normals Value beyond LVEF not fully established, further studies underway Cost-effectiveness being assessed

Many methods to further risk stratify patients at risk for SCA have been studied... : 

Many methods to further risk stratify patients at risk for SCA have been studied... Siddiqui A, Kowey PR. Curr Opin Cardiol. 2006;21:517-25. Prior SG, et al. Eur Heart J, Vol 22:16:August 2001 But a reduced EF remains the single most important risk factor for overall mortality and sudden cardiac death.

Slide 36: 

The Economics of Therapy

Incremental Cost-EffectivenessCardiovascular Interventions : 

Incremental Cost-EffectivenessCardiovascular Interventions HypertensionTherapy(diastolic95 - 104mmHg) Expensive Borderline Cost-Effective Cost-Effective HighlyCost-Effective Incremental Cost per Life-Year Saved Economically Unattractive Lovastatin(chol. = 290 mg/dL,50 yrs old, male, no riskfactors) PTCA (chronic CAD,severe angina1 VD) CABG (chronic CADmild angina,3 VD) End Stage Renal Disease Treatment Exercise SPECT (atypical angina who can walk on treadmill) RoutineCoronaryAngiography (35 - 84 yrs old, low risk MI,has CHF) $8,461 $17,701 $40,750 $67,000 $135,000 $150,000 Carotid Disease Screening (65 yrs old, male, no symptoms) $1,000,000 $120,000 Moss AJ. Satellite Symposium, 2003. Kupersmith J. Progress in Cardiovascular Diseases. 1995;37:5:307-346. Stanton M. Circulation. 2000;101:1067-1074.

Incremental Cost-Effectiveness of ICD Therapies : 

Incremental Cost-Effectiveness of ICD Therapies Al-Khatib SM, et al. Ann Intern Med. 2005;142:593-600. Larsen G, et al. Circulation. 2002;105:2049-2057. Mark DB. Circulation. 2006;114:135-142. http://circ.ahajournals.org Incremental Cost per Life-Year Saved MADIT-IIICD2 AVIDICD3 $50,000 $67,000 Expensive Borderline Cost-Effective Cost-Effective HighlyCost-Effective Economically Unattractive SCD-HeFTICD1 $38,000 $0 $20,000 $40,000 $60,000 $80,000 $100,000 $120,000 $140,000 $160,000 $180,000 $200,000

Number-Needed-to-Treat (NNT) to Save One Life for ICDs and Various Drugs : 

Number-Needed-to-Treat (NNT) to Save One Life for ICDs and Various Drugs Camm J, Klein H, Nisam S. European Heart Journal. doi:10.1093/eurheart/eji166; 2006

Slide 40: 

Implications for Real-World Practice

Patient Case : 

Patient Case History 78 year old man Wheelchair bound due to automobile accident Plays bridge competitively Lives in assisted-living PMHX: NIDCM, HF class II, sinus node dysfunction treated with a pacemaker, EF measured in 2000 was 30% Medications: ACE-I, BB, Diuretic

Patient Case : 

Patient Case Clinical Decisions Should this patient be referred for an ICD evaluation? What factors enter into your decision? Is there anything else you'd want to know before making the decision?

Slide 43: 

Myerburg RJ, et al. Circulation. 1998. 97:1514-1521. Sudden Death Risk

Discussion: Practice Realities : 

Discussion: Practice Realities Questions If you were to implement a new SCA algorithm in your practice, what would happen? What do you see as possible problems in implementing the guidelines? Are there situations that are unique to your practice?

Slide 45: 

ICD Treatment Algorithms

Slide 46: 

EF Clinic Program Patient Screening Pathway(The Ohio Heart & Vascular Center)

ICD Practical Flowchart : 

ICD ICD Practical Flowchart LVEF ≤ 35% Optimal Medical Therapy NYHA Class III – IV, Wide QRS? YES NO CRT-D NO Prior MI No Prior MI EF ≤30% MADIT II NYHA II/III EPS + MADIT-1 NYHA II/III Syncope OR OR Source: Narayan SM. Current Issues in Cardiology. 2005:32:3. COMPANION SCD-HeFT

Key Points : 

Key Points The majority of cases are in patients with: Coronary artery disease, previous MI Low left ventricular ejection fraction Dilated cardiomyopathy and heart failure Defibrillation is the only effective treatment option High-risk patients can be evaluated for known risk factors before they experience a Sudden Cardiac Arrest EF remains a key indicator

In Summary… : 

In Summary… SCA is a leading cause of death There is solid clinical evidence for ICDs as: The only effective means to prevent SCD Superior to optimal medical therapy ICDs are cost-effective There are practical ways to assess SCA risk in ischemic and non-ischemic populations Sudden Cardiac Death CAN be Prevented With an ICD

Slide 50: 

Brief Statement Medtronic ICDs Indications Medtronic implantable cardioverter defibrillators (ICDs) are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Contraindications Medtronic ICDs are contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, patients with incessant VT or VF, patients who have a unipolar pacemaker, and patients whose primary disorder is bradyarrhythmia. Warnings/Precautions Changes in a patient¹s disease and/or medications may alter the efficacy of the device¹s programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over the device. Potential Complications Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate tachyarrhythmia episodes, acceleration of ventricular tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis. See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic¹s website at www.medtronic.com. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.