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Sudden Cardiac Death • Definition – Death occurs within minutes – Cardiac in nature – Unwitnessed death • Incidence – 375,000 people suffer Sudden Cardiac Death per year – Approximately 43 people every hour – 75,000 (20%) survive Sudden Cardiac Arrest Magnitude of SCA in the U.S. Stroke3 167,366 Lung Cancer2 157,400 1 2 3 4 Breast Cancer2 40,600 AIDS1 42,156 SCA claims more lives each year than these other diseases combined 450,000 SCA4 #1 Killer in the U.S. U.S. Census Bureau, Statistical Abstract of the United States: 2001. American Cancer Society, Inc., Surveillance Research, Cancer Facts and Figures 2001. 2002 Heart and Stroke Statistical Update, American Heart Association. Zheng Z. Circulation. 2001;104:2158-2163. Sudden Cardiac Arrest is one of the Leading Causes of Death in the U.S. 300,000 250,000 200,000 150,000 100,000 50,000 0 AIDS Breast Cancer Lung Cancer Stroke Source: Statistical Abstract of the U.S. 1998, Hoover’s Business Press, 118 th Edition SCA Sudden Cardiac Death • Causes – 80-90% are tachyarrhythmias – Only 10-20% are due to an acute myocardial infarction or to bradyarrhythmias Underlying Arrhythmia of Sudden Cardiac Arrest Primary VF 8% Torsades de Pointes 13% VT 62% Adapted from Bayés de Luna A. Am Heart J. 1989;117:151-159. Bradycardia 17% Coronary Heart Disease • An estimated 13 million people had CHD in the U.S. in 2002. 1 • Sudden death was the first manifestation of coronary heart disease in 50% of men and 63% of women. 1 • CHD accounts for at least 80% of sudden cardiac deaths in Western cultures.3 Etiology of Sudden Cardiac Death2,3 5% Other* 15% Cardiomyopathy 1 American Heart Association. Heart Disease and Stroke Statistics—2003 Update. Dallas, Tex.: American Heart Association; 2002. 2 Adapted from Heikki et al. N Engl J Med, Vol. 345, No. 20, 2001. 3 Myerberg RJ. Heart Disease, A Textbook of Cardiovascular Medicine. 6th ed. P. 895. 80% Coronary Heart Disease * ion-channel abnormalities, valvular or congenital heart disease, other causes SCD CAD Risk Factors “Reduced left ventricular ejection fraction (LVEF) remains the single most important risk factor for overall mortality and sudden cardiac death.”1 Control Group Mortality at2 years SCD Rates in Post-MI Patients with LV Dysfunction 30 28 Total Mortality Arrhythmic Mortality 28 21 20 20 18 16 19.8 16 14 12 10 10 9.4 7 0 TRACE CAPRICORN EMIAT MADIT MUSTT Inducible MUSTT Registry MADIT II* Total Mortality ~20-30%; SCD accounts for ~50% of the total deaths. References in slide notes. * MADIT-II mortality values at 20 months. Treatments to Reduce SCD Correcting Ischemia – Revascularization – Beta-blocker Preventing Plaque Rupture – Statin – ACE inhibitor – Aspirin Stabilizing Autonomic Balance – Beta-blocker – ACE inhibitor Zipes DP. Circulation. 1998;98:2334-2351. Pitt B. N Engl J Med. 2003;348:1309-1321. Improving Pump Function – ACE inhibitor – Beta-blocker Prevention of Arrhythmias – Beta-blocker – Amiodarone Terminating Arrhythmias – ICDs – AEDs Prevent Ventricular Remodeling and Collagen Formation Ann Noninvasive Electrocardiol. 1999;4:83-91 MADIT II (1997-2002) Multicenter Automatic Defibrillator Implantation Trial II • Objective - To evaluate the role of ICD vs. medical therapy in a group of patients with left ventricular dysfunction and MI • Inclusion - Post MI patients with EF < 30%. No prior assessment of VT in the EP lab. Requirement for freq. PVC’s was dropped six months in to the study (only 23 pts enrolled). • Exclusion - Approved indication for an ICD; Undergone coronary revascularization within 3-months; An MI within the past 1-month MADIT II Multicenter Automatic Defibrillator Implantation Trial II • Patients - 1,232 randomized in a 3:2 ratio to receive an ICD (752) or conventional medical therapy (490) • Results - Over a 4-yr period with an average follow-up of 20-months, the ICD group resulted in a 5.6% absolute and 31% relative risk reduction in mortality over conventional group - 14.2% vs. 19.8% respectively – Study terminated early due to this favorable result MADIT II Multicenter Automatic Defibrillator Implantation Trial II Probability of Survival Moss, A. et. al. N Engl J Med 2002;877-83 Reductions in Mortality with ICDs Compared to Antiarrhythmic Drugs 60% % Mortality Reduction 60% 54% 50% 40% 37% 31% 30% 20% 20% 10% 0% AVID1 CASH2 CIDS3 MADIT4 MUSTT5 3 years 2 years 3 years 2 years 5 years 3 1 The AVID Investigators. N Engl J Med. 1997;337:1576-1583. 2 Kuck K. ACC98 News Online. April, 1998. Press release. Connolly S. ACC98 News Online. April, 1998. Press release. AJ. N Engl J Med. 1996;335:1933-1940. 5 Buxton AE. N Engl J Med. 1999;341:1882-1890. 4 Moss Incremental Cost-Effectiveness Results ($LYS)* $200 $180 Expensive $160 $LYS (X 1000) Unattractive $174,100 $140 $120 $100 $91,500 $80 Borderline Cost Effective Cost Effective $57,300 $60 $44,300 $40 $20 $18,200 $27,000 $28,400 Highly Cost Effective $0 CABG ICD Chronic CAD Mild Angina 3 VD1 Therapy2 *Versus Conventional Therapy 1 Kupersmith. Progress in Cardiovascular Disease. 1995. 2 Captopril Post MI EF < .401 Cardiac Peritoneal Transplant CHF Transplant Candidate1 Dialysis3 Owens. Annals of Internal Medicine. 1997. PTCA Anticoag. Chronic CAD Mitral Mild Angina Stenosis 1 VD LAD1 NSR, Female Age 351 3 Kupperman. Circulation. 1990 GOAL OF ICD THERAPY • 375,000 people suffer Sudden Death each year • Only 20% survive • In 1985, the only indication for AICD implantation was survival of 2 sudden death episodes • Today, we are attempting to identify those patients who are at high risk and treat them prior to SCD EF Clinic Program Patient Screening Pathway (The Ohio Heart & Vascular Center) PATIENT Does patient have history of cardiac arrest, VF, or symptomatic VT? YES Consult EP for possible ICD Note: Pathway only begins after optimal medical therapy & coronary evaluation / intervention as appropriate NYHA Class II or III CHF NYHA Class I CHF 40 days post MI with EF ≤ 30% Is patient on optimal medical therapy? NO Optimize therapies or consult HF specialist Consult EP for possible ICD YES Determine EF EF ≤ 35% EF > 35% 1. Consider referral to HF Specialist or HF Program. 2. Repeat diagnostics with change of symptoms. Ischemic Non-Ischemic Class III or IV CHF and QRS > 120 ms 40 days post MI OR 3 months post revascularization 3 months post diagnosis Consult EP for possible CRT-D Consult EP for possible ICD Consult EP for possible ICD This is a general protocol to assist in the management of patients. This protocol is not designed to replace clinical judgment or individual patient needs. Indications for ICD Class I 1. Cardiac Arrest – Due to VT or VF – Not due to transient or reversible cause 2. Spontaneous sustained VT – Structural heart disease must be present 3. Syncope of undetermined origin with: – Sustained VT that has clinical relevance and/or hemodynamic significance – VF induced during EP study when drug therapy to sustained VT is not preferred Indications for ICD Class I 4. Nonsustained VT with: – – – – Coronary disease Prior MI LV Dysfunction Inducible VF or sustained VT (Non-suppressible by antiarrhythmic drugs) 5. Spontaneous sustained VT – Not amenable to other treatments Indications for ICD Class IIa 1. LVEF <30% at: – 1 month post MI – 3 months post coronary revascularization Indications for ICD Class IIb 1. Cardiac Arrest – Assumed due to VF – EP test precluded by other medical conditions 2. Symptomatic sustained VT while awaiting cardiac transplant 3. Conditions with life-threatening risk – Long QT Syndrome – Hypertrophic cardiomyopathy Indications for ICD Class III 1. Syncope of undetermined origin – Without structural heart disease – No inducible VT or VF 2. Incessant VT or VF 3. VT or VF with an ablatable or surgically treatable cause – WPW, LVOT VT, ILVT, Fascicular VT 4. Transient or reversible VT – Due to AMI, electrolyte imbalance, drugs or trauma Indications for ICD Class III 5.Psychiatric illness that may: – Be aggravated by device implantation – Preclude follow-up 6.Terminal illness – <6 month life expectancy ICD Evolution Evolution of ICD Technology ICD Evolution THEN… • Required major surgery • Nonprogrammable • High-energy shock only • Indicated for 2X SCD survivors only • 1 ½ year longevity • < 1,000 implants/year ICD Evolution …and NOW • Transvenous, single incision • Local anesthesia, conscious sedation • Programmable therapy options • Single, dual and triple chamber • Up to 9 years longevity • > 100,000 implants/year ICD Evolution The ICD System * Animation How it Works The ICD System How it Works Atrium & Ventricle Ventricle • • • • VT prevention Antitachycardia pacing Cardioversion Defibrillation • Bradycardia sensing • Bradycardia pacing • Antitachycardia pacing ICD Device Components (Header) (Used for Telemetry) Question? What is the function of an ICD? • • • • Sense Detect Therapy Pace Question? What is Sensing? • The process of identifying cardiac depolarizations from an intracardiac electrogram • It’s what the device sees Sensing • Sensing - what the device “sees” • Electrical Activity - what the device is look for • Lead – contains the ‘eyeball’ of the device The EGM Signal Farfield Morphology Comparison SINUS RHYTHM VT EGM Source = Variable Marker Channel™ ICD Function Annotations •Therapy: –TP = Anti-Tachycardia Pacing Initiated (ATP) –CE = Charge End –CD = Charge Delivered * in Medtronic devices Detection Detection Rate •Measured in: – Beat-to-beat intervals (milliseconds), or – Beats-per-minute (BPM) •Classifies rhythm by detection zone: –VT = Ventricular Tachycardia –VF = Ventricular Fibrillation •Programmable in ranges of rates Example: VT = 162 bpm – 188 bpm VF = 188 bpm and faster Question? Can you name some therapies delivered by an ICD? ICD Therapies • ICD Therapy – Low Power (Pacing Therapies) • Anti-tachycardia Pacing (ATP • Bradyarrhythmia Pacing – High Power (Shock Therapies) • Cardioversion • Defibrillation ICD Therapies •Tachyarrhythmia Therapy –Anti-Tachycardia Pacing (ATP) Low Power •Pacing pulses delivered at a rate faster than the rhythm detected •Can successfully terminate re-entrant tachycardias Anti-Tachycardia Pacing * Animation Click image to view animation Anti-Tachycardia Pacing Re-entry initiated ATP delivered at a rate faster than tachyarrhythmia. Wavefronts collide. Subsequent Pulses: Wavefronts collide even closer to re-entry circuit Subsequent Pulse: Wavefronts collide closer to re-entry circuit Arrhythmia terminated Cardioversion • Delivers shock on an R-wave • Aborts if synchronization cannot be obtained due to arrhythmia termination Defibrillation * Animation Click image to view animation ICD Therapy Benefits of Tiered Therapy VT FVT VF Bradyarrhythmia Therapy Pacing Modes •Most ICDs offer: – Single Chamber Pacing •AAI(R), VVI(R) and VOO – Dual Chamber Pacing •DDD(R), DDI(R), DOO and ODO •Mode Switch – Separate post-shock pacing programming •Ensures capture