Implantable Electronic Cardiac Devices for Prevention of Sudden Cardiac Death and Treatment of Cardiac Arrhythmias. What are the Limits to Use It? Limits and Interfaces in Science São Paulo, November 28-30, Roberto Costa

Implantable Cardiac Devices Sudden Cardiac Death Current Statistics National Vital Statistics Report. 2001;49;11. MMWR. 2002;51: 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 SCD is a leading cause of death in the U.S., second to all cancers combined.

Implantable Cardiac Devices Sudden Cardiac Death Current Statistics Incidence (cases/year) Survival Worldwide3,000,000<1% U.S.450,0005% W. Europe400,0005% Brazil250,000 NA American Heart Association. Heart Disease and Stroke Statistics – 2009 Update DATASUS ; Sociedade Brasileira de Cardiologia

Implantable Cardiac Devices Causes of Sudden Cardiac Death Albert CM. Circulation. 2003;107: % Other Cardiac Cause 88% Arrhythmic Cause

Implantable Cardiac Devices Mechanisms of Sudden Arrhythmic Death Bayés de Luna A. Am Heart J. 1989;117: Bradycardia 17% VT 62% Primary VF 8% Torsades de Pointes 13%

Implantable Cardiac Devices 1958 First Antiarrhythmic Devices

Implantable Cardiac Devices Antibradycardia Devices Conventional Pacemakers

Implantable Cardiac Devices Rassi A. Not published data Survival (Years) % Survival p < 0,01 Treatment of Atrioventricular Block Conventional Pacemakers

Implantable Cardiac Devices Implantable Electronic Cardiac Devices Historical Aspects ’s 1994 Hyman Senning and Elmquist 1st implant of an electronic PM Mirowski Development of the 1st ICD – implant in dogs 1st report of CRT RECENTLY Furman 1st endocardiac PM Heart Failure control Home Monitoring

Implantable Cardiac Devices Antitachycardia Devices Implantable Cardioverter Defibrillator

Implantable Cardiac Devices Antitachycardia Devices Implantable Cardioverter Defibrillator

Implantable Cardiac Devices NEJM 1997;337; Secondary Prevention of Sudden Arrhythmic Death AVID Study

Implantable Cardiac Devices N of Patients at Risk ICD (0.91)274 (0.84) 110 (0.78) 9 Conventional (0.90)170 (0.78) 65 (0.69) 3 Moss AJ. N Engl J Med 2002;346: ICD Conventional P = Survival Probability Years % Primary Prevention of Sudden Arrhythmic Death MADIT II Study

Implantable Cardiac Devices Longer Shorter Relaxed Courtesy of Dr Kass, MD, Johns Hopkins University, Maryland. SEPTUM BASE APEX SEPTUM BASE Normal Dilated Cardiomyopathy APEX Left Ventricular Dysfunction Electromechanical Dyssynchrony

Implantable Cardiac Devices Cortesia de D. Kass, MD, Johns Hopkins University, Maryland. SEPTUM BASE APEX SEPTUM BASE APEX Longer Shorter Relaxed Normal Activation Electromechanical Delay Left Ventricular Dysfunction Electromechanical Dyssynchrony

Implantable Cardiac Devices Cardiac Resynchronization Atrio-biventricular Pacing LVRV

Implantable Cardiac Devices Cleland et al, Eur Heart J 2006;27(16): Days P< Event-free Survival Control CRT N of Patients at Risk Medical Therapy CRT 100 HF CF III/IV EF<0.35 QRS>130ms Cardiac Resynchronization CARE-HF Study: Overall Mortality

Implantable Cardiac Devices Cardiac Resynchronization CARE-HF Study: Sudden Mortality Cleland et al, Eur Heart J 2006;27(16): CRT Medical Therapy Survival Time (days) Hazard ratio 0.54 (95% CI P = 0.006) CRT = 32 sudden deaths (7.8%) Medical therapy = 54 sudden deaths (13.4%)

Implantable Cardiac Devices Cardiac Resynchronization + ICD COMPANION Study: Overall Mortality N Engl J Med 2005 CRT-D CRT TMO Sobrevida livre de eventos (%) 19% 12% 15% N:1520

Implantable Cardiac Devices Implantable Electronic Cardiac Devices Historical Aspects ’s 1994 Hyman Senning e Elmquist 1st implant of an electronic PM Mirowski Development of the 1st ICD – implant in dogs 1st report of CRT RECENTLY Furman 1st endocardiac PM Heart Failure control Home Monitoring

Implantable Cardiac Devices Remote Transmission of Arrhythmias Therapies Applied by the Device

Implantable Cardiac Devices HIGH intrathoracic impedance indicates dry lungs Better Worse Clinical and Hemodynamical Diagnosis Analysis of the Thoracic Impedance LOW intrathoracic impedance indicates pulmonary congestion

Implantable Cardiac Devices Pressure Change (9 of 12) Hospitalization Days Relative to Event Baseline Recovery Baseline Recovery Percent Change Percent Change RV Sistolic Pressure Estimated Pulmonary Artery Diastolic Pressure Heart Rate Continuous Volemia Evaluation Possibility of a Precocious Intervention Adamson PB et al. J Am Coll Cardiol. 2003; 41: 565

Implantable Cardiac Devices PatientTransmitterWireless transmission* Service centerData sent to the physician Remote Monitoring System * By landline phone or GSM network

Implantable Cardiac Devices  Device Complications  Clinical Complications In-clinic Follow-up Next evaluation ( days) Remote Monitoring System

Implantable Cardiac Devices 24% of all stroke events Remote Transmission of Arrhythmias Atrial Fibrillation

Implantable Cardiac Devices Atrial Fibrillation Incidence

Implantable Cardiac Devices May 2009 Last statistical analysis N = 260 patients Loss to follow-up: 3 Without 1st consultation: 31 Remote Monitoring 116 Control Group patients Atrial Fibrillation in the Elderly with Pacemaker Inclusion and Randomization

Implantable Cardiac Devices Inclusion Age ≥ 60 years Classic indication for AVPM implant or replacement Surgical procedure Randomization 1:1 0-7 days after surgery Intervention group Remote monitoring MAS ≥ 10% - extra consultation Control group Booked for ambulatory consultation months Atrial Fibrillation in the Elderly with Pacemaker Study Design

Implantable Cardiac Devices Event-free Survival GI = 22 (19%) GII = 23 (20.9%) p=0.52 Intervention Control Total=45 episódios (19,91%) Total=45 episodes (19.91%) Atrial Fibrillation in the Elderly with Pacemaker Episodes Incidence (months)

Implantable Cardiac Devices Atrial Fibrillation in the Elderly with Pacemaker Incidence of new AF episodes after follow-up p=0,08 Median (days) Average (days) ,9679,9 RemotoControle P = 0,045 Time to diagnosys of AF (months)

Implantable Cardiac Devices Conducts in Extra Consultations (23) Atrial Fibrillation in the Elderly with Pacemaker Conducts Established in Extra Consultations

Implantable Cardiac Devices (5 Yr) (2.4 Yr) (3 Yr) (3 Yr) (3.5 Yr) (1 Yr) (6 Yr) (2 Yr) (5 Yr) (2.4 Yr) (3 Yr) (3 Yr) (3.5 Yr) (1 Yr) (6 Yr) (2 Yr) NNT x years = 100 / (% Mortality in Control Group – % Mortality in Treatment Group) ICD Therapy simvastatin captopril Metoprolol succinate amiodarone Drug Therapy Cardioverter Defibrillator Number Needed to Treat

Implantable Cardiac Devices $0.6$0.6 $2.0 $2.8 $4.6 $6.8 $8.5 $14.9 Weighted DRG payment 2003 with discharges from HCUPnet. Medicare 2000 Dialysis payment per patient: The United States Renal Data System (USRDS), Weighted DRG payment for 2003 using weighted 2002 industry implants (CRT, CRT+ICD), including replacements DialysisCABGStent Hip / Knee ReplacementHeartValves ICD AorticAneurysmCRT $16 Procedure $ Billion Yearly Expenditures for Medical Procedures DRG Payment by Procedure Dialysis $ 54,262 Heart Valves33,525 ICD 30,394 CRT 25,112 CABG 24,272 Aortic Aneurysm17,655 Stent11,646 Hip / Knee Replacement10,365 Total Comparative Expenses Influence of the Prevalence

Implantable Electronic Cardiac Devices for Prevention of Sudden Cardiac Death and Treatment of Cardiac Arrhythmias. What are the Limits to Use It? Limits and Interfaces in Science São Paulo, November 28-30, Roberto Costa