limits and interfaces in science são paulo, november 28-30, 2009

Implantable Electronic Cardiac Devices Implantable Electronic Cardiac Devices for Prevention of Sudden Cardiac Death for Prevention of Sudden Cardiac Death and Treatment of Cardiac Arrhythmias. and Treatment of Cardiac Arrhythmias.

What are the Limits to Use It?What are the Limits to Use It?

Limits and Interfaces in ScienceSão Paulo, November 28-30, 2009.

Roberto [email protected]

Implantable Cardiac DevicesImplantable Cardiac DevicesSudden Cardiac Death Sudden Cardiac Death Current StatisticsCurrent Statistics

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

SCD is a leading cause of death in the U.S., second to all cancers

combined.

Implantable Cardiac DevicesImplantable Cardiac DevicesSudden Cardiac Death Sudden Cardiac Death Current StatisticsCurrent Statistics

Incidence Incidence (cases/year)(cases/year)

SurvivalSurvival

Worldwide 3,000,000 <1%

U.S. 450,000 5%

W. Europe 400,000 5%

Brazil 250,000NA

American Heart Association. Heart Disease and Stroke Statistics – 2009 UpdateDATASUS - 2008; Sociedade Brasileira de Cardiologia - 2008

Implantable Cardiac DevicesImplantable Cardiac Devices

Causes of Sudden Cardiac Death

Albert CM. Circulation. 2003;107:2096-2101.

12%Other Cardiac

Cause

88%Arrhythmic

Cause

Implantable Cardiac DevicesImplantable Cardiac DevicesMechanisms of Sudden Arrhythmic Death

Bayés de Luna A. Am Heart J. 1989;117:151-159.

Bradycardia17%

VT62% Primary VF

8%

Torsades de Pointes13%

Implantable Cardiac DevicesImplantable Cardiac Devices1958First Antiarrhythmic DevicesFirst Antiarrhythmic Devices

Implantable Cardiac DevicesImplantable Cardiac DevicesAntibradycardia DevicesConventional PacemakersConventional Pacemakers


Rassi A. Not published dataRassi A. Not published data

Survival (Years)

% S

urvi

val

p < 0,01p < 0,01

Treatment of Atrioventricular BlockConventional Pacemakers

Implantable Cardiac DevicesImplantable Cardiac DevicesImplantable Electronic Cardiac Devices Implantable Electronic Cardiac Devices Historical AspectsHistorical Aspects

1932 1958 1964 1970 1980’s 1994

HymanHyman

Senning Senning and and

ElmquistElmquist1st implant 1st implant

of an of an electronic electronic

PMPM

MirowskiMirowskiDevelopme

nt of the 1st ICD –

implant in dogs

1st report 1st report of CRTof CRT

RECENTLY

FurmanFurman1st 1st

endocardiac endocardiac PMPM

Heart Heart Failure Failure controlcontrol

Home Home MonitoringMonitoring

Implantable Cardiac DevicesImplantable Cardiac DevicesAntitachycardia DevicesImplantable Cardioverter Implantable Cardioverter DefibrillatorDefibrillator


NEJM 1997;337;1576-83

Secondary Prevention of Sudden Arrhythmic DeathAVID StudyAVID Study


N of Patients at RiskN of Patients at RiskICDICD 742 742 502 (0.91)502 (0.91) 274 (0.84)274 (0.84) 110 (0.78) 9 110 (0.78) 9ConventionalConventional 490 490 329 (0.90)329 (0.90) 170 (0.78)170 (0.78) 65 (0.69) 65 (0.69) 33

Moss AJ. N Engl J Med 2002;346:877-Moss AJ. N Engl J Med 2002;346:877-883883

ICDICD

ConventionalConventionalP = 0.007P = 0.007

1.0

0.9

0.8

0.7

0.6

0.0

Surv

ival

Su

rviv

al

Prob

abili

tyPr

obab

ility

0 1 2 3 4YearsYears

0.780.78

0.60.699

-31%-31%

Primary Prevention of Sudden Arrhythmic DeathMADIT II StudyMADIT II Study


Longer

Shorter

Relaxed

Courtesy of Dr Kass, MD, Johns Hopkins University, Maryland.

SEPTUMBASE

APEX

SEPTUM BASE

NormalNormal Dilated CardiomyopathyDilated Cardiomyopathy

APEX

Left Ventricular DysfunctionLeft Ventricular DysfunctionElectromechanical DyssynchronyElectromechanical Dyssynchrony


Cortesia de D. Kass, MD, Johns Hopkins University, Maryland.

SEPTUMBASE

APEX

SEPTUM BASE

APEX

Longer

Shorter

Relaxed

Normal ActivationNormal Activation Electromechanical DelayElectromechanical Delay

Left Ventricular DysfunctionLeft Ventricular DysfunctionElectromechanical DyssynchronyElectromechanical Dyssynchrony

Implantable Cardiac DevicesImplantable Cardiac DevicesCardiac ResynchronizationCardiac ResynchronizationAtrio-biventricular PacingAtrio-biventricular Pacing

LVRV


Cleland et al, Eur Heart J 2006;27(16):1928-32 Cleland et al, Eur Heart J 2006;27(16):1928-32

0 500 1000 15000

25

50

75

Days

P<0.0001 Eve

nt-f

ree

Surv

ival

571192321365404889213351376409

ControlCRT

N of Patients at N of Patients at RiskRisk

Medical Therapy

CRT

100HF CF III/IVEF<0.35QRS>130ms

Cardiac ResynchronizationCardiac ResynchronizationCARE-HF Study: Overall MortalityCARE-HF Study: Overall Mortality

Implantable Cardiac DevicesImplantable Cardiac DevicesCardiac ResynchronizationCardiac ResynchronizationCARE-HF Study: Sudden MortalityCARE-HF Study: Sudden Mortality

Cleland et al, Eur Heart J 2006;27(16):1928-32 Cleland et al, Eur Heart J 2006;27(16):1928-32

CRT

Medical Therapy

Surv

ival

Time (days)

Hazard ratio 0.54(95% CI 0.35-0.84. P = 0.006)

CRT = 32 sudden deaths (7.8%)Medical therapy = 54 sudden deaths (13.4%)

1.00

0.75

0.50

0.25

0.000 400 800 1200 1600

Implantable Cardiac DevicesImplantable Cardiac DevicesCardiac Resynchronization + ICDCardiac Resynchronization + ICDCOMPANION Study: Overall MortalityCOMPANION Study: Overall Mortality

N Engl J Med 2005N Engl J Med 2005

CRT-D

CRT

TMO

Sobr

evid

a liv

re d

e ev

ento

s (%

)

19%

12%

15%

N:1520

Implantable Cardiac DevicesImplantable Cardiac DevicesImplantable Electronic Cardiac Devices Implantable Electronic Cardiac Devices Historical AspectsHistorical Aspects

1932 1958 1964 1970 1980’s 1994

HymanHyman

Senning e Senning e ElmquistElmquist

1st implant 1st implant of an of an

electronic electronic PMPM

MirowskiMirowskiDevelopme

nt of the 1st ICD –

implant in dogs

1st report 1st report of CRTof CRT

RECENTLY

FurmanFurman1st 1st

endocardiac endocardiac PMPM

Heart Heart Failure Failure controlcontrol

Home Home MonitoringMonitoring

Implantable Cardiac DevicesImplantable Cardiac DevicesRemote Transmission of ArrhythmiasRemote Transmission of ArrhythmiasTherapies Applied by the DeviceTherapies Applied by the Device


HIGH HIGH intrathoracic impedance intrathoracic impedance indicates dry lungsindicates dry lungs

BetterBetter WorseWorse

Clinical and Hemodynamical DiagnosisClinical and Hemodynamical DiagnosisAnalysis of the Thoracic ImpedanceAnalysis of the Thoracic Impedance

LOW LOW intrathoracic impedance intrathoracic impedance indicates pulmonary indicates pulmonary

congestioncongestion


PressurPressure e

Change Change (9 of 12)(9 of 12)

HospitalizationHospitalization

Days Relative to Event Baseline -7 -6 -5 -4 -3 -2 -1 Baseline -7 -6 -5 -4 -3 -2 -1 RecoveryRecovery

Per

cent

Cha

nge

Perc

ent

Chan

ge

-10-10

00

1010

2020

3030

4040

RV Sistolic PressureRV Sistolic Pressure

Estimated Pulmonary Estimated Pulmonary Artery Diastolic Artery Diastolic PressurePressureHeart RateHeart Rate

Continuous Volemia EvaluationContinuous Volemia EvaluationPossibility of a Precocious InterventionPossibility of a Precocious Intervention

Adamson PB et al. J Am Coll Cardiol. 2003; 41: 565


Patient Transmitter

Wireless transmission*

Service center

Data sent to the physician

Remote Monitoring SystemRemote Monitoring System

* By landline phone or GSM network


Device ComplicationsDevice Complications Clinical ComplicationsClinical Complications

In-clinic In-clinic Follow-upFollow-up

Next Next evaluation evaluation

(90-180 (90-180 days)days)

Remote Monitoring SystemRemote Monitoring System


24% of all stroke events

Remote Transmission of ArrhythmiasRemote Transmission of ArrhythmiasAtrial FibrillationAtrial Fibrillation


Atrial FibrillationAtrial FibrillationIncidenceIncidence


May 2009 May 2009 Last statistical Last statistical

analysisanalysis

N = 260 patients

Loss to follow-up: 3Without 1st consultation:

31

Remote Monitoring116

Control Group110

226 patients

Atrial Fibrillation in the Elderly with Atrial Fibrillation in the Elderly with PacemakerPacemakerInclusion and RandomizationInclusion and Randomization


Inclusion• Age ≥ 60 years• Classic indication for AVPM implant or replacement

Surgical procedure

Randomization Randomization 1:11:1

0-7 days after 0-7 days after surgerysurgery

Intervention groupIntervention group

Remote monitoringRemote monitoring

MAS ≥ 10% - extra consultationMAS ≥ 10% - extra consultation

Control groupControl group

Booked for ambulatory consultationBooked for ambulatory consultation

11 33 1818121266 2424 monthsmonths

Atrial Fibrillation in the Elderly with Atrial Fibrillation in the Elderly with PacemakerPacemakerStudy DesignStudy Design


Event-free SurvivalEvent-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 Atrial Fibrillation in the Elderly with PacemakerPacemakerEpisodes IncidenceEpisodes Incidence

(months)

Implantable Cardiac DevicesImplantable Cardiac DevicesAtrial Fibrillation in the Elderly with PacemakerAtrial Fibrillation in the Elderly with PacemakerIncidence of new AF episodes after Incidence of new AF episodes after follow-upfollow-up

p=0,08

Median (days)Average (days)

38 56 39,96 79,9

Remoto Controle

P=0,045

Tim

e to

dia

gnos

ys o

f AF

(mon

ths)


Conducts in Extra Consultations (23)Conducts in Extra Consultations (23)

Atrial Fibrillation in the Elderly with Atrial Fibrillation in the Elderly with PacemakerPacemakerConducts Established in Extra ConsultationsConducts Established in Extra Consultations


(5 Yr) (2.4 Yr) (3 Yr) (3 Yr) (3.5 Yr) (1 Yr) (6 Yr) (5 Yr) (2.4 Yr) (3 Yr) (3 Yr) (3.5 Yr) (1 Yr) (6 Yr) (2 Yr) (2 Yr)

NNTNNTx yearsx years = 100 / (% Mortality in Control Group – % Mortality in Treatment Group) = 100 / (% Mortality in Control Group – % Mortality in Treatment Group)

ICD TherapyICD Therapysimvastatin

captopril

Metoprololsuccinate

amiodarone

Drug TherapyDrug Therapy

Cardioverter DefibrillatorCardioverter DefibrillatorNumber Needed to TreatNumber Needed to Treat


$0.6$0.6$0.6$0.6$2.0$2.0

$2.8$2.8

$4.6$4.6

$6.8$6.8

$8.5$8.5

$14.9$14.9

Weighted DRG payment 2003 with discharges from 2000. HCUPnet. www.ahrq.gov/data/hcupnet.htmWeighted DRG payment 2003 with discharges from 2000. HCUPnet. www.ahrq.gov/data/hcupnet.htmMedicare 2000 Dialysis payment per patient: The United States Renal Data System (USRDS), 2002.. Medicare 2000 Dialysis payment per patient: The United States Renal Data System (USRDS), 2002..

www.usrds.org www.usrds.org Weighted DRG payment for 2003 using weighted 2002 industry implants (CRT, CRT+ICD), including Weighted DRG payment for 2003 using weighted 2002 industry implants (CRT, CRT+ICD), including

replacementsreplacements

DialysisDialysis CABGCABG StentStent Hip / KneeHip / KneeReplacementReplacement

HeartHeartValvesValves

ICDICD AorticAorticAneurysmAneurysm

CRTCRT00

22

44

66

88

1010

1212

1414

$16$16

ProcedureProcedure

$ Bi

llion

$ Bi

llion

Yearly Expenditures for Medical ProceduresYearly Expenditures for Medical Procedures

DRG Payment by ProcedureDRG Payment by ProcedureDialysisDialysis $ $ 54,26254,262

Heart ValvesHeart Valves 33,52533,525ICDICD 30,39430,394CRTCRT 25,11225,112CABGCABG 24,27224,272Aortic AneurysmAortic Aneurysm 17,65517,655StentStent 11,64611,646Hip / Knee ReplacementHip / Knee Replacement 10,36510,365

Total Comparative ExpensesTotal Comparative ExpensesInfluence of the PrevalenceInfluence of the Prevalence

Implantable Electronic Cardiac Devices Implantable Electronic Cardiac Devices for Prevention of Sudden Cardiac Death for Prevention of Sudden Cardiac Death and Treatment of Cardiac Arrhythmias. and Treatment of Cardiac Arrhythmias.

What are the Limits to Use It?What are the Limits to Use It?

Limits and Interfaces in ScienceSão Paulo, November 28-30, 2009.

Roberto [email protected]

limits and interfaces in science são paulo, november 28-30, 2009

Documents

processo da morte sbita

morte sbita cardaca

sudden cardiac arrest

of death in the

morte do paciente

casos de morte sbita

the limits

dispositivos implantveis