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Device Therapy for Heart Failure
Whats new on the Horizon?
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Congestive Heart Failure
Heart (or cardiac) failure is the state in which theheart is unable to pump blood at a rate
commensurate with the requirements of the tissues
or can do so only from high pressures
Braunwald 8th Edition, 2001
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A Key Indicator for Diagnosing Heart Failure
Ejection Fraction (EF)
Ejection Fraction (EF) is the percentage of blood that is
pumped out of your heart during each beat
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Pathologic Progression of CV Disease
Pathologic
remodeling
Low ejection
fraction Death
Symptoms:
DyspneaFatigue
Edema
Chronic
heartfailure
Neurohormonalstimulation
Myocardialtoxicity
Sudden
Death
Pumpfailure
Coronary arterydisease
Adapted from Cohn JN. N Engl J Med. 1996;335:490498.
Hypertension
Cardiomyopathy
Valvular disease
Myocardial
injuryDiabetes
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Hormones and Hemodynamics
Schrier et al, NEJM 1999
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Congestive Heart FailureCongestive Heart Failure
400,000 5.0 million
Annual
Incidence
Heart Failure
Prevalence
U.S.
Annual
Mortality
250,000
Up to 30 % of CHF patients have an IVCD (80% with a LBBB) which has been
linked to increases in mortality and morbidity.
CHF is the leading cause hospitalizations in the US and uses up 5% of the health
care costs (1999 stats)
1-2% of the population and 6% of the population >65
Prevalence is on the rise.
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NYHA ClassNYHA Class--eva luates the disabilityeva luates the d isability
imposed on the patientimposed on the patient
Class I
Asymptomatic
heart failure
ejection fraction
(EF)
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Hospita l disc harges for heart fa ilure
(United States: 1979-2006)
Source: NHDS/NCHS and NHLBI
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Prevalence of heart fa ilure by age and sex(NHANES: 2005-2006)
Source: NCHS and NHLBI
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Trends in Cardiovascular Operations and Proc edures(United States: 1979-2006)
Source: NCHS and NHLBI
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Heart Failure Therapy by Stages
Jessup M., Brozena S. N Engl J Med 2003; 348:2007-2018
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Rational for Medications
(Why does my doctor have me on so many pills??)
Improve Survival
Betablockers
ACE-inhibitors
Aldosterone blockers
Angiotensin receptor blockers
(ARBs)
Improve Symptoms
Diuretics (water pills)
digoxin
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Device Therapy
Implantable Cardioverter-Defibrillators (ICD)
Cardiac Resynchronization Therapy (CRT)
Left Ventricular Assist Devices (LVAD)
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Implantable Cardioverter Defibrillator(ICD) Therapy
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Cause of Death in Community HF Clinic
Alhosaini, H: Heritage Heart Failure Clinic Registry
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SCD in Heart FailureSCD in Heart Failure
60%
70%
80%
90%
100%
0 60 120 180 240 300 360
Days
CumulativeSurvival
Duration(msec)
140 ms)
Other factors are:age, creatinine, EF,
and HR
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QRS
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>220
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SCD in Heart FailureSCD in Heart Failure
Degree of SCD risk by class
Mortality in NYHA class II is 5 to 15%
50 to 80% of the deaths are Sudden
Mortality in NYHA class III is 20 to 50%
Up to 50% of the deaths are Sudden
Mortality in NYHA class IV is 30 to 70%
5 to 30% of deaths are Sudden
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Sudden Cardiac Arrest (SCA) in HF
The underlying arrhythmia in most cases is ventricular
tachycardia (VT) degenerating to ventricular fibrillation
(VF)
Although pharmacologic therapies serve a role in reducing
mortality, they are not as effective as ICDs in preventing
SCA recurrence ICDs have become the therapy of choice in patients with
structural heart disease and symptomatic VT or VF
Tholakanahalli, N: Current Heart Failure Reports, Sep 2009
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SCA Resusc ita tion
Suc cess versus Time*
10
20
30
4 0
50
6 0
70
8 0
9 0
10 0
0 1 2 3 4 5 6 7 8 9
%Success
*N o n - l i n e a r
Tim e (m in u t e s )
Ch a n ce o f s u c ce s s r e d u ce d
7-10 % ea ch m in u te
Cummins RO. Annals Emerg Med. 1989;18:1269-1275.
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SCA Chain of Survival Statistics
Even in the best EMS/early defibrillation programs, it is
difficult to achieve high survival times due to any SCA
events not being witnessed and the difficulty of reaching
victims within 6-8 minutes.
48% to 58% SCAs not witnessed1,2
85% SCAs occur at home/non-public1
4.6% to 8% estimated SCA out-of-hospital survival1,2
1 Nichol G, et al. JAMA. 2008;300:1423-1431.2Chugh SS, et al. J Am CollCardiol. 2004;44:1268-1275.
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Implantable Cardioverter Defibrilla tor (ICD)
Defib r illa t ion th e r ap y fo r SCA
P a in le s s te r m in a t io n o f m o s ta r r h yt h m ia s w it h a n t it a ch yca r d ia
p a c in g (ATP)
R e d u c e d u n n e ce s sa r y r igh tve n t r icu la r p a cin g
Co m p r e h e n s ive d i a gn o s t ic
in fo r m a t io n fo r m o r e in s igh t fu lp a t ie n t a s s es s m e n t
Au t o m a t ic in t r a t h o r a c ic
im p e d a n ce ( flu id ) m o n it o r in g
MEDTRONIC Electronic Library
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Implantable Cardioverter Defibrillators (ICDs) Restore sinus rhythm in the presence of tachycardia
Defibrillate
Cardiovert
Anti-Tachy Pace (ATP)
Provide a rate to support metabolic needs
Includes single or dual chamber pacing
Provide various diagnostics
About 6-9 years longevity
R i i S
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Recognizing SystemsICD or High Power
Right Atrial Lead
Approximate position outlined
Right Ventricular Lead
With RV and SVC coils
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ICD Pacing Therapy
Atrium and Ventricle
Sensing
Pacing Ventricle
Antitachycardia pacing (ATP)
Atrial Lead
Ventricular Lead
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High-Voltage Therapy
Cardioversion andDefibrillation are delivered in
biphasic waves
For example: First, from the SVCcoil and the Can to the RV coil,
and then reverse.
The device must detect charge
confirm and deliver the shock.
Fast, accurate detection, and fast
charge times are critical
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ICD Therapy
Brady and Anti-
Tachy pacing(ATP)
The ICD lead isdesigned to carry bothhigh voltage andpacing therapies
Brady
ATP
Cardioversion
Defibrillation
Typically about a 7Fdiameter lead
Indications
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IndicationsDefibrillators
Well defined by Heart Rhythm Society (HRS) and include:
Cardiac Arrest
Due to VT or VF, not transient or reversible Spontaneous sustained VT with structural heart disease
Syncope of undetermined origin with:
Sustained VT or VF induced during EP
Nonsustained VT with:
Coronary disease or prior MI and LV Dysfunction
Inducible VF or sustained VT (non-suppressible by antiarrhythmic drugs)
Spontaneous sustained VT
Not amenable to other treatments
Indications
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IndicationsDefibrillators
ICD Class I Recommendation
Patients at least 40 days post-MI
LVEF 30 40%
NYHA class II or III
Non-ischemic patients
LVEF 30 35%
NYHA class II or III
Patients at risk of SCA due to genetic disorders
Long QT syndrome
Brugada syndrome
Hypertrophic cardiomyopathy (HCM)
Arrhythmogenic right ventricular dysplasia (ARVD)
Note: This list includes the current major indications for an ICD
Indications
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IndicationsDefibrillators
Primary vs. Secondary Prevention for SCA
Secondary
Patients who have experienced a previous SCA or ventricular arrhythmia
Studies such as AVID1, CIDS2, CASH3 support the use of ICDs in this
population
Primary Patients who have not previously experienced SCA/VA, but are at risk
Studies, such as MADIT II4 and SCD-HeFT5, have demonstrated the use
of ICDs in these patients
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Implantable Cardiac Defribrillators
EBM Therapies Relative Risk
Reduction
Mortality
2 year
ACE-I 23% 27%
-Blockers 35% 12%
Aldosterone
Antagonists
30% 19%
ICD 31% 8.5%
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Primary Prevention of SCA in
Ischemic Cardiomyopathy
Several randomized trials evaluated ICD therapy for primary
prevention of SCA in patients with impaired LV systolic
function due to ischemic heart disease
Tholakanahalli, N: Current Heart Failure Reports, Sep 2009
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Primary Prevention of SCD in
Ischemic Cardiomyopathy
199 6-MADIT Tr ial : EF
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Primary Prevention of SCD in
Ischemic Cardiomyopathy
20 0 2 -MADIT I I Tr ia l : EF
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Primary Prevention of SCD in
Dilated Non-Ischemic Cardiomyopathy
20 0 5-SCD-H eFT Tr ia l : Ischemic (52%) and Non-ischemic (48%) EF
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Secondary Prevention of SCA in HF
Patients who have been successfully resuscitated fromcardiac arrest remain at risk for developing future life-threatening ventricular arrhythmias
A meta-analysis of three randomized controlled trialsdemonstrated a nearly 30% relative risk (RR) reduction in all-
cause mortality for ICD therapy in patients who survived anepisode of VT or VF
The benefit was more profound in patients with an LVEF lessthan 35%
Tholakanahalli, N: Current Heart Failure Reports, Sep 2009
AVID T i l S d P ti
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AVID Trial- Secondary Prevention
N Engl J Med 1997, 337:15761583
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ICD Therapy in Special Groups
Elderly heart failure patients
Hypertrophic cardiomyopathy
CRT with or without ICD
Reversible cardiomyopathies
Bridge to transplant
Non-compaction cardiomyopathy and ARVD
Tholakanahalli, N: Current Heart Failure Reports, Sep 2009
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ICD Therapy in Special Groups- Elderly
The mean age of patients in major ICD trials has been
between 60 and 65 years old
only a few patients older than 75
The current evidence in elderly patients is limited to
subgroup analysis of prospective randomized ICD trials
Tholakanahalli, N: Current Heart Failure Reports, Sep 2009
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ICD Therapy in Special Groups- HCM
1) Premature HCM-related death of one or
2) History of unexplained syncope
3) Multiple and/or prolonged runs of nonsustained VT on 24-
hour Holter monitoring
4) Hypotensive or attenuated blood pressure response to
exercise
5) Massive LV hypertrophy (maximum wall thickness 30 mm)
Tholakanahalli, N: Current Heart Failure Reports, Sep 2009
ICD Therapy in Special Groups-
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ICD Therapy in Special Groups
Reversible Cardiomyopathy
A 78-year-old man who had a history of persistent AF
presented with NYHA class III HF symptoms LVEF was 20% on echocardiogram with global hypokinesis
He underwent successful electrical cardioversion followed byantiarrhythmic therapy with Amiodarone for sinus rhythmmaintenance
After being in sinus rhythm for 3 months, his LVEF improved to40%, which further increased to 60% after 6 months
His HF symptoms completely resolved with improvement of hisLVEF
Tholakanahalli, N: Current Heart Failure Reports, Sep 2009
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ACC/AHA Heart Failure Guidelines
ICDin Primary Prevention
ICD therapy is recommended for primary
prevention of sudden cardiac death to reduce totalmortality in patients with nonischemic dilated
cardiomyopathy or ischemic heart disease at least
40 days post-myocardial infraction, have an LVEF
less than or equal to 35%, with NYHA functionalclass II or III symptoms while receiving chronic
optimal medical therapy, and who have reasonable
expectation of survival with a good functional status
for more than 1 year
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
Jessup, M,: ACC/AHA Heart Failure Guidelines Update- JAAC 2009
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ACC/AHA Heart Failure Guidelines
ICD in Secondary Prevention
A cardioverter-defibrillator (ICD) is
recommended as secondary prevention to
prolong survival in patients with current or prior
symptoms of HF and reduced LVEF who have ahistory of cardiac arrest, ventricular fibrillation, or
hemodynamically destabilizing ventricular
tachycardia
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
Jessup, M,: ACC/AHA Heart Failure Guidelines Update- JAAC 2009
Implant Evolution
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Implant Evolution
ICD Past: ~10-12 years ago ICDs
Required major surgery
Abdominal implants
Median sternotomy to suturedefib patches on heart
Length of hospital stay > 1 week
Nonprogrammable
High-energy shock only
Indicated for patients who
survived cardiac arrest - twice
1 year longevity
209 cc
< 1,000 implants/year
Implant Evolution
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Implant Evolution
ICDs Today
Similar to a pacemaker implant
Transvenous, single incision
Pectoral implant
Overnight stay
Local anesthesia, conscious
sedation
Programmable therapy options
Single, dual and triple chamber
(CRT)
Up to 9 years longevity
About 35 cc
> ~100,000 implants/year
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Cardiac Resynchronization Therapy(CRT)
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No r m a l ECG Act iva t io n
This pattern of depolarization results in efficient mechanical contraction
CorePace- Arrhythmias & Devices- Medtronic Educational Resources
LBBB RV d LV A ti ti
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LBBB: RV and LV Activation
Atlas of Electrophysiology in Heart Failure
L f B d l B h Bl k
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Left Bu n d le Br a n ch Block
European Journal of Heart Failure 9 (2007) 7 14
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LBBB: Prevalence in General Population
Eriksson P. Circulation 1998;98;2494-2500
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LBBB: Prevalence in Heart Failure
82%
18%
QRSduration (msec)
PrevalenceofQRSduration>120msec
inacommunitybasedheartfailureclinic
(n=210)>120msec
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CRT Evolution : DDD Pacing
Am J Cardiol 1990;66:198-202
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CRT Evolution: DAVID Trial
JAMA 2002;288(24):3115-3123
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CRT Evolution : First Report
NASPE Abstracts March 1994
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Mechanisms
Mechanisms of Dysfunction Due to
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Mechanisms of Dysfunction Due to
Contractile Discoordination
Red u ced E jec t ion
V o l u m e
M ech an o -E n e rg e t i c
Inef f ic iency
La te
Systo l ic Str et ch
R e d u c e dF o rce
Delayed
Relaxa t ion
After-c o n t r a c t i o n / a r r h y t h m i a s
P ap illa r y m u s c led i s co o rd i n a t i o n
M it r a l Va l ve
Dysfunct ion
I n t e r n a ls losh ing fr omp r e m a t u r e -
ac t iva tedreg ion( se p t u m ) t ola te ac t iva t edreg ion( la t e r a l wa ll)
I n c r e a s e dend-sys to l icv o l u m e( s t r e s s )
Red u ced sys to li cfu n c tio n d e s p it em a in t a i n e d o r
i n c r e a s e den er ge t ic cos t
Adapted from Kass DA- Device Therapy in Heart Failure
CRT I l t ti
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CRT- Implantation
Medtronic - Physicians Resources Library
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Biventricular Pacing
NEJM-Biventricular Pacing, Interactive Illustration
Biventricular Pacing
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g
Biventricular Pacing
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g
Biventricular Pacing
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Yu et al. Circulation 2002;105;438-445
CRT in Mild to Moderate HF
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CRT in Mild to Moderate HF
CRT in Mild to Moderate HF
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CRT in Mild to Moderate HF
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The Cardiac ResynchronizationClinical Trials
PATH-CHF, MUSTIC, MIRACLE,
COMPANION, and CARE-HF*
*This is not a complete list of all the CRT trials and the dates given are when the trial results
were published.
Cumulative Enrollment in CardiacCumulative Enrollment in Cardiac
Resynchronization RandomizedResynchronization Randomized
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Resynchronization RandomizedResynchronization Randomized
TrialsTrials
0
1000
2000
3000
4000
1999 2000 2001 2002 2003 2004 2005
Result s Present ed
C
um
ulat
ive
Patients
PATH CHF
MUSTIC SR
MUSTIC AF
MIRACLE
CONTAK CD
MIRACLE ICD
PATH CHF II
COMPANION
MIRACLE ICD II
CARE HF
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FDA Approval
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The first CRT device was approved
by the FDA in September 2001 .
The first CRT with an ICD wasapproved by the FDA in May 2002 .
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ACC/AHA/NASPE 2002 Indications forCardiac Resynchronization Therapy
Class II a ( Level A) Indication for Biventricular Pacing in DilatedCardiomyopathy
Biventricular pacing in medically refractory, symptomatic NYHA
Class III/IV patients with idiopathic dilated or ischemiccardiomyopathy, prolonged QRS interval ( 130 msec), LV enddiastolic diameter 55mm, and LVEF 35%
COMPANION:2004
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Comparison of Medical Therapy, Pacing andDefibrillation in Heart Failure
OPT
1
OPT
CRT+2
OPT
CRT-D+
3
Randomization
COMPANION
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Enrolled 1520 patients class 3 and 4, QRS >120ms Primary endpoint: death or hospitalization for any cause
CRT met the primary endpoints and the CRT +/- ICD significantlyreduces mortality
This was the first to show mortality benefit from CRT alone
Showed that patients with CRT also benefit from ICD therapy
OPT had SCD in 36%, 23% in CRT and 2.9% in CRT+ICD
COMPANIONCOMPANION
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CRT arm had 20% reduction in mortality andhospitalization over OPT arm but it was not statistically
significant
Significant reduction in CRT-ICD arm of 40% for mortalityover OPT arm (19% in OPT and 11% in CRT-ICD group)
Study was halted prematurely due to its positive benefit.
Mean follow up was 16 months
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ACC/ AHA Guidelines
Patients with LVEF less than or equal to 35%,sinus rhythm, and NYHA functional class IIIor ambulatory class IV symptoms despiterecommended, optimal medical therapy andwho have cardiac dyssynchrony, which iscurrently defined as a QRS duration greaterthan or equal to 0.12 seconds, should receivecardiac resynchronization therapy, with orwithout an ICD, unless contraindicated.
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
Patient Selection for CRT
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Heart failure with low ejection fraction less
than 35%
Symptomatic despite optimal medical
regimen
LBBB- type conduction delay with QRS
duration at least 120 msec
Normal Sinus Rhythm
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Patient Selection for CRT
CRT is not a rescue modality
CRT is not indicated in end-stage patients
What is the definition of optimal medical therapy?
Unresolved Issues in Patient Selection for CRT
Wh t i d h ? El t i l
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What is dyssynchrony? Electrical vs.
mechanical vs. combination
Patients with narrow QRS complex
Patients who are less or not symptomatic
i.e. NYHA II and I
CRT-D vs. CRT-alone
Ischemic vs. Non-ischemic etiology
Case Discussion
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Mr. JW is a 65 year-old man with ischemic cardiomyopathy
and heart failure NYHA III-IV with repeated hospitalization
for DHF No new coronary lesions that are amenable to intervention
EKG with LBBB and QRSd 130 msec
He is adherent to medications and has an excellent
insurance coverage
El i l
El t i l P i
P ti t
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Electricalvariables
Electricalvariables
PatientActivity
PatientActivity
Thoracicfluid content
Thoracicfluid content
IntracardiacPressures
IntracardiacPressures
Recognizing SystemsCRT Low-Power
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Right Atrial Lead
Left Ventricular Lead
Placed on the surface of the
LV via the Coronary Sinus
Right Ventricular Lead
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Left Ventricular Assist Device
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Left- Ventricular Assist Device(LVAD) Therapy
Patient Selection
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Current Opinion in Cardiology 2009, 24:246251
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LVAD Selection
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N Engl J Med
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LVAD Mechanisms
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N Engl J Med
Continuous vs. Pulsatile Flow LVAD
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N Engl J Med 361;23
Continuous Flow LVAD
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N Engl J Med 361;23
Current FDA-approved LVAD Devices
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Curr Probl Cardiol 2010;35:8-64.
Current LVAD Devices
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Curr Probl Cardiol 2010;35:8-64.
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ThoratecThoratec VAD (VAD (pVAD/iVADpVAD/iVAD))
Pneumatic, external(pVAD) or internal (iVAD), pulsatile pump(s)
i ht l ft bi t i l t (RVAD/LVAD/BiVAD)
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right-, left-, or bi-ventricular support (RVAD/LVAD/BiVAD)
up to ~7.2 lpm flow
Short- to medium-term use (up to ~1-2 years)
bridge to recovery
bridge to transplant
hospital discharge possible
iVADpVAD
Thoratec pVADThoratecThoratec pVADpVAD
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7/31/2019 Device for Heart Failure
111/130
111
HeartMateHeartMate XVE LVASXVE LVAS
Internally implanted, electric pulsatile pump
left heart support only
-
7/31/2019 Device for Heart Failure
112/130
112
up to 10 lpm flow
Medium- to long-term therapy (months to years)
bridge to transplant
destination therapy (only FDA-approved DT device)
Heart Mate II LVASHeart Mate II LVAS Internally implanted, axial-flow (non-pulsatile) device
left heart support only
-
7/31/2019 Device for Heart Failure
113/130
113
speed: 8000-15000 rpm
flow: ~3-8 lpm
Medium- to long-term therapy (months to years)
bridge to transplant (FDA-approved)
destination therapy (investigational)
Jarvik 2000 LVADJarvik 2000 LVAD
Axial-flow (non-pulsatile) pump
electric intra-ventricular
-
7/31/2019 Device for Heart Failure
114/130
114
electric, intra-ventricular
left heart support only
Speed: 8000-12000 rpm
flow: ~3-5 lpm
Medium- to long-term therapy (months to years)
bridge to transplant (investigational)
Jarvik 2000 LVADJarvik 2000 LVAD
-
7/31/2019 Device for Heart Failure
115/130
115
Tandem Heart
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7/31/2019 Device for Heart Failure
116/130
116
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117/130
117
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118/130
Status Check
Given the following patient
67 YO male patient, had an anterior MI 2 years ago
EF 20%
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119/130
119
EF 20%
History includes
Tobacco 2 packs/day Hyperlipidemia
CAD
Medications
Vasopril (ACE Inhibitor) Lipitor (Statin)
Carvedilol (Beta Blocker) Digoxin
Furosemide (Lasix)
C/O
Severe shortness of breath at rest, fatigue, unable to perform ADL, vertigo, rare
syncope
Status Check
Patients ECG:
What device
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7/31/2019 Device for Heart Failure
120/130
120
NSRRate 78
LBB
What device
system (if
any) is thepatient likely
to get?
Click for Answer
High-Power
CRT
Wide QRS, EF