Implantable Electronic Cardiac Devices for Prevention of Sudden Cardiac Death and Treatment of Cardiac Arrhythmias. What are the Limits to Use It? Limits.

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 Science

São Paulo, November 28-30, 2009.

Roberto Costa

[email protected]

Implantable Cardiac DevicesImplantable Cardiac DevicesImplantable Cardiac DevicesImplantable Cardiac Devices

Sudden 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.


Sudden 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


Causes of Sudden Cardiac Death

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

12%Other Cardiac

Cause

88%Arrhythmic

Cause


Mechanisms of Sudden Arrhythmic Death

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

Bradycardia17%

VT62% Primary VF

8%

Torsades de Pointes13%


1958First Antiarrhythmic DevicesFirst Antiarrhythmic Devices


Antibradycardia DevicesConventional PacemakersConventional Pacemakers


Rassi A. Not published dataRassi A. Not published data

Survival (Years)

% S

urv

ival

p < 0,01p < 0,01

Treatment of Atrioventricular BlockConventional Pacemakers


Implantable Electronic Cardiac Devices Implantable Electronic Cardiac Devices Historical AspectsHistorical Aspects

1932 1958 1964 1970 1980’s 1994

HymanHyman

Senning Senning and and

ElmquistElmquist

1st implant 1st implant of an of an

electronic electronic PMPM

MirowskiMirowski

Development of the 1st ICD –

implant in dogs

1st report 1st report of CRTof CRT

RECENTLY

FurmanFurman

1st 1st endocardiac endocardiac

PMPM

Heart Heart Failure Failure controlcontrol

Home Home MonitoringMonitoring

Implantable Cardiac DevicesImplantable Cardiac DevicesImplantable Cardiac DevicesImplantable Cardiac DevicesAntitachycardia DevicesImplantable Cardioverter Implantable Cardioverter DefibrillatorDefibrillator

Implantable Cardiac DevicesImplantable Cardiac DevicesImplantable Cardiac DevicesImplantable Cardiac DevicesAntitachycardia DevicesImplantable Cardioverter Implantable Cardioverter DefibrillatorDefibrillator


NEJM 1997;337;1576-83

Secondary Prevention of Sudden Arrhythmic Death

AVID 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

Su

rviv

al

Su

rviv

al

Pro

bab

ilit

yP

rob

ab

ilit

y

0 1 2 3 4YearsYears

0.780.78

0.60.699

-31%-31%

Primary Prevention of Sudden Arrhythmic Death

MADIT II StudyMADIT II Study


Longer

Shorter

Relaxed

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

SEPTUMBASE

APEX

SEPTUMBASE

NormalNormal Dilated CardiomyopathyDilated Cardiomyopathy

APEX

Left Ventricular DysfunctionLeft Ventricular DysfunctionElectromechanical DyssynchronyElectromechanical Dyssynchrony


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

SEPTUMBASE

APEX

SEPTUMBASE

APEX

Longer

Shorter

Relaxed

Normal ActivationNormal Activation Electromechanical DelayElectromechanical Delay

Left Ventricular DysfunctionLeft Ventricular DysfunctionElectromechanical DyssynchronyElectromechanical Dyssynchrony


Cardiac 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 Even

t-fr

ee

Su

rviv

al

571192321365404889213351376409

Control

CRTN 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


Cardiac 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

Su

rviv

al

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


Cardiac Resynchronization + ICDCardiac Resynchronization + ICDCOMPANION Study: Overall MortalityCOMPANION Study: Overall Mortality

N Engl J Med 2005N Engl J Med 2005

CRT-D

CRT

TMO

So

bre

vid

a liv

re d

e ev

ento

s (%

)

19%

12%

15%

N:1520


Implantable 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

MirowskiMirowski

Development of the 1st ICD –

implant in dogs

1st report 1st report of CRTof CRT

RECENTLY

FurmanFurman

1st 1st endocardiac endocardiac

PMPM

Heart Heart Failure Failure controlcontrol

Home Home MonitoringMonitoring


Remote 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

Perc

en

t C

han

ge

Perc

en

t C

han

ge

-10-10

00

1010

2020

3030

4040

RV Sistolic PressureRV Sistolic Pressure

Estimated Pulmonary Estimated Pulmonary Artery Diastolic Artery Diastolic PressurePressure

Heart 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 DevicesImplantable 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 t

o d

iag

nosys o

f A

F

(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

CRTCRT

00

22

44

66

88

1010

1212

1414

$16$16

ProcedureProcedure

$ B

illion

$ B

illion

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 Science

São Paulo, November 28-30, 2009.

Roberto Costa

[email protected]

Implantable Electronic Cardiac Devices for Prevention of Sudden Cardiac Death and Treatment of Cardiac Arrhythmias. What are the Limits to Use It? Limits.

Documents

cardiac causes

sudden cardiac arrest

leading cause of death

cancers scd

eur heart j

roberto costa

days p