Implantable Electronic Cardiac Devices: Limits and Interfaces in Science Symposium

1. Limits and Interfaces in Science São Paulo, November 28-30, 2009. Implantable Electronic Cardiac Devices for Prevention of Sudden Cardiac Death and Treatment of Cardiac Arrhythmias. What are the Limits to Use It? Roberto Costa rcosta@incor.usp.br

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

3. SuddenCardiacDeath CurrentStatistics American Heart Association. Heart Disease and Stroke Statistics – 2009 Update DATASUS - 2008; Sociedade Brasileira de Cardiologia - 2008

4. Causes ofSuddenCardiacDeath 12%Other CardiacCause 88%ArrhythmicCause Albert CM. Circulation. 2003;107:2096-2101.

5. MechanismsofSuddenArrhythmicDeath Torsades de Pointes13% Bradycardia17% VT62% Primary VF8% Bayés de Luna A. Am Heart J. 1989;117:151-159.

6. 1958 FirstAntiarrhythmicDevices

7. AntibradycardiaDevices ConventionalPacemakers

8. Treatmentof Atrioventricular Block ConventionalPacemakers % Survival p < 0,01 Survival (Years) Rassi A. Notpublished data

9. Implantable Electronic Cardiac Devices HistoricalAspects SenningandElmquist 1st implantofanelectronic PM Mirowski Developmentofthe 1st ICD – implant in dogs Furman 1st endocardiac PM 1st reportof CRT RECENTLY 1994 1932 1958 1964 1970 1980’s Hyman HeartFailurecontrol Home Monitoring

10. AntitachycardiaDevices ImplantableCardioverterDefibrillator

11. AntitachycardiaDevices ImplantableCardioverterDefibrillator

12. SecondaryPreventionofSuddenArrhythmicDeath AVID Study NEJM 1997;337;1576-83

13. PrimaryPreventionofSuddenArrhythmicDeath MADIT II Study 1.0 0.9 0.78 ICD 0.8 Survival Probability -31% 0.7 0.69 Conventional P = 0.007 0.6 0.0 0 1 2 3 4 Years N of Patients at Risk ICD 742 502 (0.91) 274 (0.84) 110 (0.78) 9 Conventional 490 329 (0.90) 170 (0.78) 65 (0.69) 3 Moss AJ. N Engl J Med 2002;346:877-883

14. Left Ventricular Dysfunction ElectromechanicalDyssynchrony Dilated Cardiomyopathy Normal Longer SEPTUM SEPTUM BASE BASE Relaxed APEX APEX Shorter Courtesy of Dr Kass, MD, Johns Hopkins University, Maryland.

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

16. CardiacResynchronization Atrio-biventricularPacing RV LV

17. CardiacResynchronization CARE-HF Study: Overall Mortality HF CF III/IV EF<0.35 QRS>130ms 100 75 CRT Medical Therapy Event-free Survival 50 25 P<0.0001 0 0 500 1000 1500 Days N of Patients at Risk 409 376 351 213 89 8 CRT 404 365 321 192 71 5 Control Clelandetal, EurHeart J 2006;27(16):1928-32

18. CardiacResynchronization CARE-HF Study: SuddenMortality 1.00 0.75 0.50 0.25 0.00 CRT Medical Therapy Hazard ratio 0.54 (95% CI 0.35-0.84. P = 0.006) Survival CRT = 32 sudden deaths (7.8%) Medical therapy = 54 sudden deaths (13.4%) 0 400 800 1200 1600 Time (days) Clelandetal, EurHeart J 2006;27(16):1928-32

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

20. Implantable Electronic Cardiac Devices HistoricalAspects Senning e Elmquist 1st implantofanelectronic PM Mirowski Developmentofthe 1st ICD – implant in dogs Furman 1st endocardiac PM 1st reportof CRT RECENTLY 1994 1932 1958 1964 1970 1980’s Hyman HeartFailurecontrol Home Monitoring

21. RemoteTransmissionofArrhythmias TherapiesAppliedbytheDevice

22. ClinicalandHemodynamicalDiagnosis AnalysisoftheThoracicImpedance HIGH intrathoracicimpedanceindicatesdrylungs LOW intrathoracicimpedanceindicatespulmonarycongestion Worse Better

23. Continuous Volemia Evaluation Possibilityof a PrecociousIntervention PressureChange (9 of 12) Hospitalization 40 30 20 PercentChange RV SistolicPressure 10 EstimatedPulmonaryArteryDiastolicPressure 0 Heart Rate -10 Baseline -7 -6 -5 -4 -3 -2 -1 Recovery DaysRelative to Event Adamson PB et al. J Am Coll Cardiol. 2003; 41: 565

24. RemoteMonitoring System Patient Transmitter Wireless transmission* Service center Data sent to the physician * By landline phoneor GSM network

25. Device Complications Clinical Complications RemoteMonitoring System In-clinic Follow-up Next evaluation (90-180 days)

26. RemoteTransmissionofArrhythmias Atrial Fibrillation 24% of all stroke events

27. AtrialFibrillation Incidence

28. Atrial Fibrillation in the Elderly with Pacemaker Inclusion and Randomization N = 260 patients Loss to follow-up: 3 Without 1st consultation: 31 226 patients RemoteMonitoring 116 Control Group 110 May 2009 Last statistical analysis

29. Remote monitoring Intervention group MAS ≥ 10% - extra consultation Atrial Fibrillation in the Elderly with Pacemaker Study Design • Inclusion • Age ≥ 60 years • Classic indication for AVPM implant or replacement Booked for ambulatory consultation Surgical procedure Randomization 1:1 Control group months 1 3 6 12 18 24 0-7 days after surgery

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

31. 38 56 Median (days) 39,96 79,9 Average (days) Atrial Fibrillation in the Elderly with Pacemaker Incidence of new AF episodes after follow-up p=0,08 P=0,045 Time to diagnosys of AF (months) Remoto Controle

32. Atrial Fibrillation in the Elderly with Pacemaker Conducts Established in Extra Consultations Conducts in Extra Consultations (23)

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

34. Total Comparative Expenses Influence of the Prevalence Yearly Expenditures for Medical Procedures DRG PaymentbyProcedure Dialysis $ 54,262 HeartValves 33,525 ICD 30,394 CRT 25,112 CABG 24,272 AorticAneurysm 17,655 Stent 11,646 Hip / KneeReplacement 10,365 $14.9 $16 14 12 10 $8.5 $ Billion 8 $6.8 6 $4.6 4 $2.8 $2.0 2 $0.6 $0.6 0 Hip / Knee Replacement Heart Valves Aortic Aneurysm CRT Dialysis CABG Stent ICD Procedure Weighted DRG payment 2003 with discharges from 2000. HCUPnet. www.ahrq.gov/data/hcupnet.htm Medicare 2000 Dialysis payment per patient: The United States Renal Data System (USRDS), 2002.. www.usrds.org Weighted DRG payment for 2003 using weighted 2002 industry implants (CRT, CRT+ICD), including replacements

35. Limits and Interfaces in Science São Paulo, November 28-30, 2009. Implantable Electronic Cardiac Devices for Prevention of Sudden Cardiac Death and Treatment of Cardiac Arrhythmias. What are the Limits to Use It? Roberto Costa rcosta@incor.usp.br