device for heart failure

7/31/2019 Device for Heart Failure

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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

-

-

-

QRS

-

-

-

>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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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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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



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Primary Prevention of SCD in


199 6-MADIT Tr ial : EF


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20 0 2 -MADIT I I Tr ia l : EF


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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%


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



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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



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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)


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



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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


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



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g



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g



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Yu et al. Circulation 2002;105;438-445

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.


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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HeartMateHeartMate XVE LVASXVE LVAS

Internally implanted, electric pulsatile pump

left heart support only


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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



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speed: 8000-15000 rpm

flow: ~3-8 lpm


bridge to transplant (FDA-approved)

destination therapy (investigational)

Jarvik 2000 LVADJarvik 2000 LVAD

Axial-flow (non-pulsatile) pump

electric intra-ventricular


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electric, intra-ventricular


Speed: 8000-12000 rpm

flow: ~3-5 lpm


bridge to transplant (investigational)

Jarvik 2000 LVADJarvik 2000 LVAD


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Tandem Heart


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Status Check

Given the following patient

67 YO male patient, had an anterior MI 2 years ago

EF 20%


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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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NSRRate 78

LBB

What device

system (if

any) is thepatient likely

to get?

Click for Answer

High-Power

CRT

Wide QRS, EF

device for heart failure

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