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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 [email protected]. Sudden Cardiac Death Current Statistics. - PowerPoint PPT Presentation
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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
Implantable Cardiac DevicesImplantable Cardiac Devices
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
Implantable Cardiac DevicesImplantable Cardiac DevicesAntitachycardia DevicesImplantable Cardioverter Implantable Cardioverter DefibrillatorDefibrillator
Implantable Cardiac DevicesImplantable Cardiac Devices
NEJM 1997;337;1576-83
Secondary Prevention of Sudden Arrhythmic DeathAVID StudyAVID Study
Implantable Cardiac DevicesImplantable Cardiac Devices
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
Implantable Cardiac DevicesImplantable Cardiac Devices
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
Implantable Cardiac DevicesImplantable Cardiac Devices
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
Implantable Cardiac DevicesImplantable Cardiac Devices
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
Implantable Cardiac DevicesImplantable Cardiac Devices
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
Implantable Cardiac DevicesImplantable Cardiac Devices
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
Implantable Cardiac DevicesImplantable Cardiac Devices
Patient Transmitter
Wireless transmission*
Service center
Data sent to the physician
Remote Monitoring SystemRemote Monitoring System
* By landline phone or GSM network
Implantable Cardiac DevicesImplantable Cardiac Devices
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
Implantable Cardiac DevicesImplantable Cardiac Devices
24% of all stroke events
Remote Transmission of ArrhythmiasRemote Transmission of ArrhythmiasAtrial FibrillationAtrial Fibrillation
Implantable Cardiac DevicesImplantable Cardiac Devices
Atrial FibrillationAtrial FibrillationIncidenceIncidence
Implantable Cardiac DevicesImplantable Cardiac Devices
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
Implantable Cardiac DevicesImplantable Cardiac Devices
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
Implantable Cardiac DevicesImplantable Cardiac Devices
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)
Implantable Cardiac DevicesImplantable Cardiac Devices
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
Implantable Cardiac DevicesImplantable Cardiac Devices
(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
Implantable Cardiac DevicesImplantable Cardiac Devices
$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]