Ventricular

Assist

Devices

Clinical

Policy

Bulletins

Medical

Clinical

Policy

Bulletins

Number

Policy

Aetna

considers

a

Food

and

Drug

Administration

FDAapproved

ventricular

assist

device

VAD

medically

necessary

for

any

of

the

following

FDAapproved

indications

As

a

bridge

to

transplant

for

members

who

are

awaiting

heart

transplantation

see

CPB

Heart

Transplantation

and

the

device

has

received

FDA

approval

for

a

bridge

to

transplant

indication

eg

HeartMate

left

ventricular

assist

system

LVAS

or

As

destination

therapy

when

all

of

the

following

criteria

are

met

The

device

has

received

FDA

approval

for

a

destination

therapy

indication

eg

HeartMate

II

LVAD

HeartWare

HVAD

and

Member

has

New

York

Heart

Association

NYHA

Class

IV

endstage

ventricular

heart

failure

and

is

not

a

candidate

for

heart

transplant

and

Member

has

failed

to

respond

to

optimal

medical

management

including

betablockers

and

angiotensinconverting

enzyme

ACE

inhibitors

if

tolerated

for

at

least

of

the

last

days

or

has

been

balloon

pump

dependent

for

days

or

has

been

IV

inotrope

dependent

for

days

and

Has

a

left

ventricular

ejection

fraction

LVEF

less

than

and

Has

demonstrated

functional

limitation

with

a

peak

oxygen

consumption

of

less

than

or

equal

to

mlkgmin

Note

This

criterion

may

be

waived

in

persons

who

are

balloon

pump

or

intravenous

inotrope

dependent

or

are

otherwise

unable

to

perform

exercise

stress

testing

Aetna

considers

VADs

experimental

and

investigational

for

all

other

indications

because

of

insufficient

evidence

in

the

peerreviewed

literature

Aetna

considers

a

FDAapproved

percutaneous

left

ventricular

assist

device

pVAD

eg

the

TandemHeart

and

the

Impella

medically

necessary

for

the

following

indications

Providing

shortterm

circulatory

support

in

cardiogenic

shock

or

As

an

adjunct

to

percutaneous

coronary

intervention

PCI

in

the

following

highrisk

patients

Persons

undergoing

unprotected

left

main

or

lastremainingconduit

PCI

with

ejection

fraction

less

than

or

Persons

with

three

vessel

disease

and

ejection

fraction

less

than

Aetna

considers

pVADs

experimental

and

investigational

for

all

other

indications

because

of

insufficient

evidence

in

the

peerreviewed

literature

Aetna

considers

FDAapproved

pediatric

VADs

medically

necessary

when

both

of

the

following

criteria

are

met

Child

has

documented

endstage

left

ventricular

failure

and

An

age

and

sizeappropriate

VAD

will

be

used

until

a

donor

heart

can

be

obtained

Aetna

considers

pediatric

VADs

experimental

and

investigational

when

criteria

are

not

met

Note

Current

FDAapproved

pediatric

VADs

include

the

Berlin

Heart

EXCOR

Pediatric

Ventricular

Assist

Device

for

children

aged

years

or

younger

and

the

HeartAssist

Pediatric

Ventricular

Assist

Device

for

children

aged

to

years

The

EXCOR

Pediatric

VAD

can

be

used

in

children

up

to

kg

body

weight

The

HeartAssist

Pediatric

VAD

can

be

used

in

children

with

a

BSA

greater

than

or

equal

to

and

less

than

Aetna

considers

FDAapproved

right

ventricular

assist

devices

RVADs

eg

the

CentriMag

Right

Ventricular

Assist

System

medically

necessary

for

temporary

circulatory

support

when

both

of

the

following

criteria

are

met

RVAD

is

used

for

up

to

days

for

members

in

cardiogenic

shock

due

to

acute

right

ventricular

failure

and

Member

is

willing

and

able

to

be

treated

with

heparin

or

an

appropriate

alternative

anticoagulant

Aetna

considers

RVADs

experimental

and

investigational

when

criteria

are

not

met

Aetna

considers

the

Impella

RP

System

medically

necessary

for

providing

circulatory

assistance

for

up

to

days

in

pediatric

or

adult

persons

with

a

body

surface

area

who

develop

acute

right

heart

failure

or

decompensation

following

left

ventricular

assist

device

implantation

myocardial

infarction

heart

transplant

or

openheart

surgery

Aetna

considers

the

use

of

mesenchymal

precursor

cells

as

adjunctive

therapy

in

recipients

of

ventricular

assist

devices

experimental

and

investigational

because

the

effectiveness

of

this

approach

has

not

been

established

Aetna

considers

implantable

aortic

counterpulsation

ventricular

assist

systems

eg

the

NuPulseCV

iVAS

and

the

Symphony

Heart

Assist

System

experimental

and

investigational

because

their

effectiveness

has

not

been

established

Also

see

CPB

Autologous

Skeletal

MyoblastMononuclear

Bone

Marrow

Cell

Transplantation

Background

A

ventricular

assist

device

VAD

is

a

mechanical

pump

that

compensates

for

the

diminished

ability

of

a

weakened

heart

by

assisting

or

replacing

the

function

of

either

the

left

or

right

ventricle

A

left

VAD

the

most

commonly

used

provides

blood

flow

throughout

the

body

while

the

right

VAD

supports

the

pulmonary

lung

circulation

VADs

may

be

utilized

for

individuals

suffering

from

reversible

cardiac

dysfunction

to

support

individuals

who

are

awaiting

heart

transplantation

or

to

provide

permanent

circulatory

support

with

endstage

heart

failure

in

those

who

are

not

candidates

for

transplantation

known

as

destination

therapy

Ventricular

assist

devices

VADs

fall

into

the

general

category

of

mechanical

circulatory

assist

devices

which

also

includes

cardiopulmonary

bypass

and

intraaortic

balloon

pumps

There

are

many

VADs

available

for

use

Important

characteristics

of

these

systems

include

location

of

the

pumping

chamber

the

specific

ventricles

that

are

supported

the

pumping

mechanism

and

how

long

support

is

indicated

either

temporary

or

long

term

support

Typically

shortterm

devices

are

extracorporeal

located

outside

the

body

and

longterm

use

are

implantable

systems

There

are

several

different

types

of

VADs

currently

in

use

the

devices

can

be

broadly

subdivided

into

centrifugal

or

pulsatile

pumps

Centrifugal

pumps

operate

on

the

principle

of

a

cyclone

Blood

is

diverted

through

cannulae

placed

in

the

right

or

left

heart

to

an

external

chamber

with

a

centrifugal

pump

Centrifugal

pumps

include

the

Biopump

the

and

the

Hemopump

Pulsatile

pumps

are

subdivided

into

pneumatic

and

electromechanical

types

Each

type

can

be

operated

in

several

different

modes

including

a

synchronous

mode

triggered

by

the

EKG

similar

to

an

intraaortic

balloon

pump

and

an

asynchronous

mode

Placement

of

the

inflow

and

outflow

cannulae

is

variable

According

to

expert

consensus

it

is

usually

preferable

to

cannulate

the

left

atrium

because

it

is

technically

easier

and

spares

the

ventricle

further

injury

However

flow

rates

are

improved

with

ventricular

cannulation

and

in

patients

awaiting

transplant

injury

to

the

myocardium

is

not

a

concern

Pulsatile

pumps

include

the

Abiomed

Thoratec

Pierce

Donachy

Novacor

and

There

is

a

small

subset

of

patents

who

experience

reversible

heart

failure

after

open

heart

surgery

despite

maximal

support

with

proper

volume

loading

drug

therapy

and

an

intraaortic

balloon

pump

The

etiology

of

the

heart

failure

in

these

patients

is

hypothesized

to

be

related

to

stunned

myocardium

Ventricular

assist

devices

have

been

used

as

a

method

of

shortterm

support

in

these

patients

Several

clinical

studies

have

demonstrated

that

a

substantial

proportion

of

patients

with

postcardiotomy

cardiogenic

shock

can

be

successfully

treated

with

a

VAD

subsequently

weaned

from

the

device

and

discharged

home

Ventricular

assist

devices

have

also

been

used

as

a

bridge

to

transplant

Several

clinical

studies

have

demonstrated

the

success

of

VADs

in

improving

survival

rates

to

heart

transplantation

In

addition

VADs

have

been

shown

to

significantly

improve

patients

functional

status

prior

to

heart

transplantation

such

that

patients

are

overall

better

surgical

candidates

The

Centers

for

Medicare

Medicaid

Services

CMS

has

published

a

decision

memorandum

liberalizing

criteria

for

coverage

of

ventricular

assist

devices

CMS

The

CMS

policy

removes

body

size

criteria

and

eases

restrictions

around

the

required

duration

of

failed

medical

therapy

and

peak

oxygen

consumption

Under

the

rule

changes

CMS

will

reimburse

ventricular

assist

devices

as

destination

therapy

when

all

of

the

following

criteria

are

met

The

device

to

be

implanted

has

received

FDA

approval

for

a

destination

therapy

indication

and

Patient

has

New

York

Heart

Association

NYHA

Class

IV

endstage

ventricular

heart

failure

and

is

not

suitable

for

heart

transplantation

and

Patient

has

failed

to

respond

to

optimal

medical

management

including

betablockers

and

angiotensinconverting

enzyme

ACE

inhibitors

if

tolerated

for

at

least

of

the

last

days

down

from

of

the

prior

days

in

the

earlier

criteria

or

patient

has

been

balloon

pump

dependent

for

days

or

patient

has

been

IV

inotrope

dependent

for

days

and

Patient

has

a

left

ventricular

ejection

fraction

LVEF

less

than

and

Patient

has

demonstrated

functional

limitation

with

a

peak

oxygen

consumption

of

less

than

or

equal

to

mlkgmin

incresed

from

mlkgmin

in

the

previous

criteria

The

CMS

removed

the

previous

requirement

that

patients

must

have

a

body

size

greater

than

because

ventricular

assist

devices

have

become

smaller

and

more

portable

The

CMS

rejected

a

proposal

to

expand

coverage

to

include

Class

IIIb

patients

The

CMS

decision

memorandum

explained

that

although

Class

IIIb

patients

were

included

in

the

pivotal

trial

of

destination

therapy

with

the

Thoratec

HeartMate

II

ventricular

assist

device

they

accounted

for

only

about

of

the

population

and

there

were

no

published

results

specific

to

that

subgroup

the

CMS

decision

memo

noted

Moreover

Class

IIIb

as

a

subclassification

is

not

widely

accepted

and

such

patients

might

not

be

possible

to

identify

accurately

enough

in

routine

clinical

practice

according

to

the

memo

The

US

Food

and

Drug

Administration

FDA

approved

VADs

include

but

may

not

be

limited

to

the

following

Bridge

to

transplant

Abiomed

HeartMate

II

HeartMate

II

LVAS

HeartMate

IP

HeartMate

SNAP

VE

LVAS

HeartMate

VE

LVAS

HeartMate

XVE

LVAS

HeartWare

VAS

Novacor

LVAS

Thoratec

IVAD

Thoratec

VAD

System

Destination

therapy

AbioMed

HeartMate

II

HeartMate

SNAPVE

LVAS

HeartMate

XVE

LVAS

HeartWare

HVAD

Pediatric

bridge

to

transplant

EXCOR

Pediatric

VAD

HeartAssist

Pediatric

VAD

formerly

known

as

DeBakey

VAD

Child

Shortterm

bridge

to

recovery

AbioMed

AbioMed

Thoratec

IVAD

Thoratec

VAD

System

In

a

prospective

cohort

study

Shuhaiber

and

colleagues

examined

the

influence

of

the

preoperative

placement

of

a

LVAD

on

survival

following

heart

transplantation

A

total

of

adults

aged

or

older

in

status

or

highest

priority

for

heart

transplantation

with

either

some

form

of

VAD

intravenous

inotrope

or

life

expectancy

of

less

than

days

were

included

in

the

study

based

on

the

United

Network

for

Organ

Sharing

Registry

to

Main

outcome

measure

was

survival

after

heart

transplantation

in

patients

who

did

and

did

not

receive

a

LVAD

The

LVAD

was

not

associated

with

Kormos

and

associates

evaluated

the

incidence

risk

factors

and

effect

on

outcomes

of

right

ventricular

failure

in

a

large

population

of

patients

implanted

with

continuousflow

LVADs

Patients

n

enrolled

in

the

HeartMate

II

LVAD

Thoratec

Pleasanton

CA

bridgetotransplantation

clinical

trial

were

examined

for

the

occurrence

of

right

ventricular

failure

Right

ventricular

failure

was

defined

as

requiring

a

right

ventricular

assist

device

or

more

days

of

inotropic

support

after

implantation

andor

inotropic

support

starting

more

than

days

after

implantation

Demographics

along

with

clinical

laboratory

and

hemodynamic

data

were

compared

between

patients

with

and

without

right

ventricular

failure

Percutaneous

ventricular

assist

devices

pVADs

are

utilized

for

shortterm

bridge

to

recovery

Examples

of

pVADs

include

but

may

not

be

limited

to

the

following

Impella

System

Impella

Percutaneous

Cardiac

Support

System

Impella

CP

Cardiac

Power

Impella

Recover

LP

and

TandemHeart

PTVA

System

pVADs

differ

from

other

types

of

VADs

as

they

are

able

to

be

placed

via

cardiac

catheterization

without

the

need

for

openchest

surgery

and

use

a

transseptal

approach

to

the

left

ventricle

the

catheter

is

advanced

across

the

intraatrial

septum

into

the

left

atrium

which

avoids

potential

difficulties

in

crossing

the

aortic

valve

The

TandemHeart

a

percutaneous

transseptal

ventricular

assist

PTVA

device

is

an

external

blood

pump

that

provides

temporary

hemodynamic

support

to

a

weakened

heart

It

is

used

for

critically

ill

patients

who

have

sustained

a

massive

myocardial

infarction

or

sudden

heart

failure

and

do

not

have

enough

blood

flow

to

support

their

organs

The

TandemHeart

augments

left

ventricular

LV

contractility

enhancing

blood

flow

until

the

patients

condition

becomes

more

stable

or

the

patient

is

strong

enough

to

undergo

an

interventional

procedure

eg

angioplasty

In

potential

heart

transplant

patients

or

patients

awaiting

a

mechanical

heart

assist

device

the

TandemHeart

is

considered

a

Rajdev

et

al

stated

that

patients

with

multivessel

disease

left

main

coronary

artery

LMCA

disease

or

left

main

equivalent

andor

moderatetosevere

LV

dysfunction

with

elevated

LV

enddiastolic

pressure

are

at

increased

risk

of

complications

during

percutaneous

coronary

intervention

PCI

The

TandemHeart

is

a

nonpulsatile

PTVA

that

offers

vital

shortterm

circulatory

support

during

highrisk

PCI

These

invetigators

assessed

the

feasibility

and

safety

of

implanting

a

prophylactic

LVAD

prior

to

highrisk

PCI

and

evaluated

the

impact

of

suturemediated

preclosure

of

the

arteriotomy

site

on

minimizing

vascular

complications

Between

April

and

November

the

TandemHeart

was

implanted

in

patients

undergoing

Vranckx

and

colleagues

reported

their

experience

with

the

TandemHeart

Between

September

to

July

this

device

supported

the

circulation

of

patients

mean

age

of

years

range

of

to

who

were

admitted

for

highrisk

either

emergency

or

elective

PCI

Successful

implantation

was

achieved

in

of

patients

The

mean

time

for

implementation

of

circulatory

support

was

mins

range

of

to

The

index

PCI

was

successful

in

all

patients

except

A

pump

flow

up

to

was

achieved

with

significant

reduction

of

LV

filling

pressures

pulmonary

capillary

wedge

pressure

and

with

AlHusami

et

al

described

their

experience

of

patients

from

December

through

May

who

underwent

PCI

with

severely

depressed

LV

systolic

function

and

complex

coronary

lesions

The

complex

coronary

lesions

included

multiple

vessel

coronary

artery

disease

left

main

LM

coronary

artery

disease

calcified

coronary

lesions

and

bypass

graft

disease

All

patients

were

clinically

assessed

to

be

at

too

high

of

a

risk

for

circulatory

collapse

without

maximal

hemodynamic

support

while

they

underwent

highrisk

PCI

The

TandemHeart

PTVA

device

may

be

able

to

provide

the

necessary

circulatory

support

needed

to

enhance

procedural

success

and

patient

safety

during

highrisk

PCI

The

Impella

LP

is

a

percutaneous

ventricular

assist

device

that

consists

of

a

catheter

which

is

passed

retrograde

through

the

aortic

valve

into

the

left

ventricle

Via

a

small

rotary

pump

located

at

the

distal

tip

it

aspirates

blood

and

delivers

it

into

the

ascending

aorta

The

Impella

Recover

LP

a

percutaneous

LVAD

is

an

intravascular

microaxial

blood

pump

designed

for

shortterm

circulatory

support

in

conditions

characterized

by

profoundly

reduced

ventricular

function

It

provides

up

to

Lmin

forward

flow

from

the

LV

into

the

systemic

circulation

The

Impella

is

mainly

used

to

manage

acute

lifethreatening

left

ventricular

Vecchio

and

colleagues

evaluated

the

feasibility

safety

and

efficacy

of

the

Impella

Recover

LP

LVAD

in

patients

with

cardiogenic

shock

or

undergoing

highrisk

PCI

A

total

of

patients

presenting

cardiogenic

shock

n

or

scheduled

for

highrisk

percutaneous

revascularization

n

were

evaluated

The

Impella

pump

was

successfully

implanted

in

all

patients

except

one

When

implanted

the

device

was

correctly

positioned

in

the

LV

and

remained

in

a

stable

position

Bleedings

occurred

in

patients

of

them

presented

cardiogenic

shock

while

renal

failure

and

severe

thrombocytopenia

were

observed

in

and

patients

respectively

all

with

Lam

and

associates

noted

that

circulatory

support

during

PCI

in

patients

with

STelement

elevation

myocardial

infarction

STEMI

aims

at

maintaining

hemodynamic

stability

and

organ

perfusion

However

continuous

flow

pumps

may

interfere

with

the

normal

pulsatile

circulation

and

the

microcirculatory

function

Sidestream

dark

field

SDF

imaging

allows

the

visualization

of

microvascular

structure

and

function

of

tissue

and

may

provide

information

regarding

the

efficacy

of

the

circulatory

support

Sidestream

dark

field

was

used

to

study

the

sublingual

microcirculation

MC

in

anterior

STEMI

patients

treated

with

PCI

patients

received

the

Impella

LP

device

Impella

group

and

patients

received

In

a

prospective

multicenter

study

Dixon

and

associates

assessed

the

safety

and

feasibility

of

the

Impella

system

in

patients

undergoing

highrisk

PCI

A

total

of

patients

who

underwent

highrisk

PCI

with

minimally

invasive

circulatory

support

employing

the

Impella

system

were

included

in

this

study

All

patients

had

poor

LV

function

ejection

fraction

less

than

or

equal

to

and

underwent

PCI

on

an

unprotected

LMCA

or

last

patent

coronary

conduit

Patients

with

recent

STsegment

elevation

myocardial

infarction

or

cardiogenic

shock

were

excluded

The

primary

safety

end

point

was

the

incidence

of

major

adverse

cardiac

events

at

Granfeldt

et

al

reported

the

use

of

the

Impella

device

at

cardiothoracic

units

in

Sweden

A

total

of

patients

men

mean

age

of

years

range

of

to

underwent

implantation

of

ImpellaLP

supporttime

to

days

ImpellaLD

supporttime

to

days

and

ImpellaRD

supporttime

to

days

between

and

Implantation

was

performed

because

of

postcardiotomy

heart

failure

surgical

group

n

or

for

various

states

of

heart

failure

in

cardiological

patients

nonsurgical

group

n

The

intention

for

the

treatments

was

mainly

to

use

the

Seyfarth

and

coworkers

examined

if

the

Impella

LP

provides

superior

hemodynamic

support

compared

with

the

intraaortic

balloon

pump

IABP

for

patients

with

cardiogenic

shock

n

The

primary

end

point

was

the

change

of

the

cardiac

index

CI

from

baseline

to

mins

after

implantation

Secondary

end

points

included

lactic

acidosis

hemolysis

and

mortality

after

days

In

patients

the

allocated

device

n

for

IABP

n

for

Impella

LP

could

be

safely

placed

One

patient

died

before

implantation

The

CI

after

mins

of

support

was

significantly

increased

in

patients

with

the

Impella

LP

In

a

review

on

circulatory

assistance

in

acute

heart

failure

Hermansen

and

colleagues

stated

that

the

findings

regarding

the

use

of

the

Impella

axialflow

recovery

system

for

circulatory

assistance

in

patients

with

acute

heart

failure

especially

for

those

with

cardiogenic

shock

not

related

to

cardiac

surgery

calls

for

cautious

optimism

Additionally

in

a

systematic

review

on

the

prevention

and

treatment

of

cardiogenic

shock

OConnor

and

Fraser

percutaneous

LVADs

are

not

listed

as

an

option

Furthermore

in

a

metaanalysis

Cheng

et

al

evaluated

potential

benefits

of

percutaneous

LVAD

on

hemodynamics

and

survival

for

the

treatment

of

cardiogenic

shock

Two

independent

investigators

searched

Medline

Embase

and

Cochrane

Central

Register

of

Controlled

Trials

for

all

controlled

trials

using

percutaneous

LVAD

in

patients

with

cardiogenic

shock

where

after

data

were

extracted

using

standardized

forms

Weighted

mean

differences

MDs

were

calculated

for

CI

mean

arterial

pressure

MAP

and

pulmonary

capillary

wedge

pressure

PCWP

Relative

risks

RRs

were

calculated

for

mortality

leg

ischemia

bleeding

and

sepsis

In

main

analysis

trials

were

combined

using

inversevariance

random

effects

approach

A

systematic

review

of

the

evidence

for

percutaneous

LVADs

from

McGill

University

Health

Center

Esfandiari

et

al

found

reported

experience

of

this

device

is

still

limited

The

systematic

review

found

that

of

publications

are

small

case

series

and

are

single

case

reports

The

review

explained

that

in

general

the

device

is

being

used

in

ways

for

prophylactic

use

and

rescue

use

The

report

found

that

the

Impella

has

been

used

prophylactically

to

provide

vascular

support

during

elective

procedures

such

as

percutaneous

coronary

interventions

in

dangerously

compromised

patients

for

a

total

of

cases

All

of

The

American

College

of

Cardiology

Levine

et

a

reviewed

the

evidence

for

the

Impella

pVAD

for

highrisk

percutaneous

coronary

intervention

PCI

They

noted

that

the

Impella

has

been

used

in

patients

with

cardiogenic

shock

as

well

as

elective

PCI

The

ACC

guideline

Levine

et

al

noted

that

the

hemodynamic

effects

of

the

Impella

have

been

studied

in

highrisk

PCI

patients

demonstrating

beneficial

left

ventricular

unloading

effect

decreased

enddiastolic

pressure

and

wall

stress

with

no

change

in

global

or

systolic

left

ventricular

function

The

guideline

stated

that

the

PROTECT

I

A

Prospective

Feasibility

Trial

Investigating

the

Use

of

the

Shuhaiber

and

colleagues

reported

their

clinical

experience

with

the

CentriMag

device

for

uni

and

biventricular

support

Between

July

and

December

patients

were

supported

using

the

CentriMag

device

were

male

Mean

age

was

range

of

to

years

Indications

for

support

at

implantation

were

cardiogenic

shock

that

included

endstage

heart

failure

and

too

ill

to

undergo

transplantation

with

questionable

neurologic

status

n

right

ventricular

failure

after

left

VAD

LVAD

implantation

n

postcardiotomy

status

n

and

acute

donor

graft

failure

after

heart

transplantation

n

PostVAD

survival

was

n

De

Robertis

et

al

reported

their

experience

with

the

Levitronix

CentriMag

shortterm

VAD

as

a

potential

bridge

prior

to

deciding

whether

a

more

expensive

device

should

be

used

or

whether

transplantation

should

be

undertaken

Since

August

moribund

patients

males

age

of

range

of

to

years

have

been

supported

with

the

CentriMag

device

as

a

bridge

to

decision

Twelve

patients

had

an

intraaortic

balloon

pump

preoperatively

had

multiorgan

failure

had

septic

shock

and

in

patients

the

neurologic

status

was

uncertain

at

the

time

of

insertion

of

the

device

Operative

mortality

On

October

the

FDA

via

humanitarian

device

exemption

approved

the

CentriMag

Right

Ventricular

Assist

System

Levitronix

LLC

Waltham

MA

to

provide

temporary

circulatory

support

The

CentriMag

is

intended

to

provide

temporary

circulatory

support

for

up

to

days

for

patients

in

cardiogenic

shock

due

to

acute

right

ventricular

failure

It

is

an

extracorporeal

continuous

flow

centrifugal

rotary

pump

intended

for

temporary

use

The

device

can

be

used

for

right

or

left

ventricular

assist

or

in

a

biventricular

configuration

The

Impella

RP

system

is

a

right

percutaneous

device

that

is

also

designed

to

provide

temporary

circulatory

support

up

to

days

It

is

intended

for

use

in

adult

or

pediatric

individuals

with

a

body

surface

area

greater

than

or

equal

to

who

develop

right

heart

failure

or

decompensation

following

LVAD

implantation

myocardial

infarction

MI

heart

transplant

or

open

heart

surgery

The

Excor

Pediatric

VAD

is

a

miniaturized

pneumatic

pump

system

designed

to

provide

mid

to

longterm

mechanical

circulatory

support

for

infants

and

children

with

severe

heart

failure

ECRI

According

to

the

manufacturer

the

Excor

pediatric

device

is

the

first

VAD

designed

specifically

for

use

in

infants

children

and

adolescents

In

December

FDA

granted

Berlin

Heart

marketing

approval

for

the

Excor

Pediatric

VAD

under

Humanitarian

Device

Exemption

HDE

status

for

use

in

pediatric

patients

with

severe

isolated

left

ventricular

or

biventricular

dysfunction

who

are

candidates

for

cardiac

transplant

and

require

circulatory

support

In

an

IDE

trial

Fraser

et

al

reported

that

survival

rates

were

significantly

higher

with

the

Excor

ventricular

assist

device

than

with

ECMO

as

a

bridge

to

transplantation

in

children

with

severe

heart

failure

The

investigators

conducted

a

prospective

singlegroup

trial

of

the

Excor

pediatric

VAD

as

a

bridge

to

heart

transplantation

Patients

years

of

age

or

younger

were

divided

into

cohorts

according

to

bodysurface

area

cohort

less

than

cohort

to

less

than

with

patients

in

each

group

Survival

in

the

cohorts

receiving

mechanical

support

with

data

censored

As

a

condition

of

approval

the

FDA

required

the

company

to

conduct

a

postapproval

study

to

evaluate

whether

safety

and

outcomes

of

Excor

use

in

general

clinical

practice

are

comparable

to

the

safety

and

outcomes

reported

in

the

IDE

trial

ECRI

In

a

multicenter

doubleblind

shamprocedure

controlled

trial

Ascheim

and

colleagues

examined

whether

allogeneic

mesenchymal

precursor

cells

MPCs

injected

during

LVAD

implantation

may

contribute

to

myocardial

recovery

A

total

of

patients

were

randomized

to

intramyocardial

injection

of

million

MPCs

or

medium

during

LVAD

implantation

The

primary

safety

endpoint

was

incidence

of

infectious

myocarditis

myocardial

rupture

neoplasm

hypersensitivity

reaction

and

immune

sensitization

days

after

randomization

Key

effectiveness

endpoints

were

functional

status

and

ventricular

function

while

temporarily

weaned

from

LVAD

support

days

after

randomization

Patients

were

followedup

until

transplant

or

months

after

randomization

whichever

came

first

StempienOtero

et

al

stated

that

clinical

trials

report

improvements

in

function

and

perfusion

with

direct

injection

of

bone

marrow

cells

into

the

hearts

of

patients

with

ischemic

cardiomyopathy

Preclinical

data

suggested

that

these

cells

improve

vascular

density

which

would

be

expected

to

decrease

fibrosis

and

inflammation

These

researchers

tested

the

hypothesis

that

bone

marrow

stem

cells

will

improve

histological

measurements

of

vascularity

fibrosis

and

inflammation

in

human

subjects

undergoing

LVAD

placement

as

a

bridge

to

cardiac

transplantation

Subjects

with

ischemic

cardiomyopathy

who

were

scheduled

for

placement

of

an

LVAD

as

a

bridge

to

transplantation

underwent

bone

marrow

aspiration

HeartWare

HVAD

System

On

September

the

US

FDA

approved

the

HeartWare

HVAD

System

Medtronic

Inc

for

destination

therapy

in

patients

with

advanced

heart

failure

who

are

not

candidates

for

heart

transplants

This

approval

comes

in

addition

to

the

existing

FDAapproved

indication

of

the

HeartWare

HVAD

System

as

a

bridge

to

cardiac

transplantation

BTT

The

HeartWare

HVAD

System

is

indicated

for

hemodynamic

support

in

patients

with

advanced

refractory

left

ventricular

heart

failure

either

as

a

Bridge

to

Cardiac

Transplantation

BTT

myocardial

recovery

or

as

Destination

Therapy

DT

in

patients

for

whom

subsequent

transplantation

is

not

planned

The

HeartWare

System

is

contraindicated

in

The

expanded

indication

was

based

on

results

from

the

ENDURANCE

and

ENDURANCE

Supplemental

trials

in

nearly

destinationtherapy

patients

The

ENDURANCE

Destination

Therapy

trial

was

a

multicenter

randomized

trial

involving

patients

with

advanced

heart

failure

who

were

ineligible

for

heart

transplantation

Between

and

in

a

twotoone

ratio

patients

were

randomized

to

a

cetrifugalflow

device

HeartWare

or

the

control

axialflow

device

an

alternative

LVAD

approved

by

FDA

for

destination

therapy

The

primary

endpoint

showed

noninferiority

of

HeartWare

for

survival

years

after

implantation

without

disabling

stroke

or

device

malfunction

leading

to

LVAD

removal

versus

The

subsequent

ENDURANCE

Supplemental

trial

was

a

prospective

randomized

controlled

multicenter

evaluation

of

the

incidence

of

neurologic

events

in

patients

receiving

the

HVAD

System

as

destination

therapy

who

received

improved

blood

pressure

management

Between

October

and

August

patients

were

randomly

selected

to

receive

either

the

HVAD

System

or

as

part

of

a

control

group

an

alternative

LVAD

approved

by

the

FDA

for

destination

therapy

in

a

twotoone

ratio

This

trial

did

not

reach

its

primary

endpoint

for

neurologic

injury

had

neurologic

injury

vs

of

the

control

group

within

year

P

however

it

did

Implantable

Aortic

CounterPulsation

Ventricular

Assist

System

eg

the

NuPulseCV

iVAS

and

the

Symphony

Heart

Assist

System

The

NuPulseCV

iVAS

Estep

and

colleagues

evaluated

the

feasibility

tolerability

and

effectiveness

of

a

strategy

for

percutaneous

IABP

placement

through

the

left

axillarysubclavian

artery

to

provide

mechanical

circulatory

support

in

patients

with

endstage

HF

as

a

bridge

to

heart

transplantation

These

researchers

developed

a

percutaneous

technique

for

placing

IABPs

in

the

left

axillary

artery

that

permits

upright

sitting

and

ambulation

They

performed

a

retrospective

review

of

data

from

patients

who

had

undergone

left

axillary

IABP

implantation

between

and

A

total

of

patients

who

received

a

left

axillary

IABP

as

a

bridge

to

transplantation

were

identified

of

whom

The

NuPulseCV

iVAS

is

designed

to

be

a

minimally

invasive

ambulatory

longterm

counterpulsation

system

for

patients

suffering

from

advanced

CHF

Compared

to

continuous

flow

LVADs

the

iVAS

has

the

potential

to

expand

therapy

to

less

sick

patients

due

to

its

expected

safer

complication

profile

The

device

does

not

need

access

to

the

heart

via

thoracotomy

or

sternotomy

making

it

forward

compatible

as

a

bridge

to

transplant

recovery

or

extending

medical

therapy

There

is

a

clinical

trial

on

the

use

of

the

NuPulseCV

iVAS

for

the

treatment

of

bridgetotransplant

patients

a

firstinhuman

FIH

study

However

this

trial

has

been

identified

as

The

Symphony

Heart

Assist

System

Cecere

and

colleagues

stated

that

current

cardiac

assist

devices

provide

full

support

require

a

major

operation

and

function

asynchronously

to

the

native

heart

In

contrast

these

researchers

developed

a

novel

circulatory

support

device

that

provides

synchronous

partial

support

and

can

be

placed

with

a

minor

operation

They

reported

the

first

clinical

implantation

with

the

Symphony

device

Patients

with

advanced

HF

despite

optimal

therapy

who

had

exhausted

all

options

were

evaluated

A

old

man

with

ischemic

cardiomyopathy

underwent

implantation

of

the

Symphony

device

in

the

right

infraclavicular

fossa

After

initiating

device

support

the

cardiac

index

increased

from

to

Furthermore

an

UpToDate

review

on

Shortterm

mechanical

circulatory

assist

devices

Aroesty

et

al

stated

that

The

intraaortic

balloon

pump

IABP

is

the

most

commonly

used

mechanical

support

device

and

it

is

the

device

interventional

cardiologists

are

most

familiar

with

It

is

inserted

easily

and

rapidly

is

the

least

expensive

of

all

the

devices

and

does

not

require

continuous

monitoring

by

technical

support

personnel

However

it

is

limited

in

that

it

is

capable

of

generating

only

modest

hemodynamic

support

and

myocardial

protection

In

addition

clinical

trials

of

patients

with

cardiogenic

shock

have

not

shown

an

improvement

in

mortality

with

its

HeartMate

Left

Ventricular

Assist

System

On

August

the

FDA

granted

premarket

approval

application

PMA

for

the

HeartMate

Left

Ventricular

Assist

System

This

device

is

indicated

for

providing

shortterm

hemodynamic

support

eg

bridge

to

transplant

or

bridge

to

myocardial

recovery

in

patients

with

advanced

refractory

left

ventricular

HF

AntiThrombotic

Therapies

in

Children

on

Durable

Ventricular

Assist

Devices

Huang

and

colleagues

state

that

VADs

are

increasingly

used

in

children

with

endstage

HF

and

experience

high

bleeding

and

clotting

rates

In

particular

pediatric

VAD

patients

are

more

challenging

than

adults

to

anticoagulate

due

to

developmental

hemostasis

lack

of

suitable

drug

preparations

and

difficult

anticoagulation

monitoring

often

due

to

poor

vascular

access

in

addition

to

difficulties

of

VAD

design

in

smaller

children

These

investigators

summarized

the

current

evidence

related

to

antithrombotic

therapy

in

pediatric

VAD

patients

They

carried

out

a

search

of

databases

across

a

period

of

time

using

key

words

selected

a

priori

Identified

publications

were

Left

Ventricular

Assist

Devices

Among

Recipients

With

Endstage

Renal

Disease

Appendix

Table

New

York

Heart

Association

NYHA

Functional

Classification

of

Heart

Failure

NYHA

Class

Symptoms

I

No

symptoms

and

no

limitation

in

ordinary

physical

activity

eg

shortness

of

breath

when

walking

climbing

stairs

etc

II

Mild

symptoms

mild

shortness

of

breath

andor

angina

and

slight

limitation

during

ordinary

activity

III

Marked

limitation

in

activity

due

to

symptoms

even

during

lessthanordinary

activity

eg

walking

short

distances

to

m

Comfortable

only

at

rest

IV

Severe

limitations

Experiences

symptoms

even

while

at

rest

Mostly

bedbound

patients

Source

New

York

Heart

Association

CPT

Codes

HCPCS

Codes

Codes

Code

Code

Description

Information

in

the

brackets

below

has

been

added

for

clarification

purposes

Codes

requiring

a

character

are

represented

by

CPT

codes

covered

if

selection

criteria

are

met

Insertion

of

ventricular

assist

device

extracorporeal

single

ventricle

extracorporeal

biventricular

Removal

of

ventricular

assist

device

extracorporeal

single

ventricle

extracorporeal

biventricular

Insertion

of

ventricular

assist

device

implantable

intracorporeal

single

ventricle

Removal

of

ventricular

assist

device

implantable

intracorporeal

single

ventricular

Replacement

of

extracorporeal

ventricular

assist

device

single

or

biventricular

pumps

single

or

each

pump

Replacement

of

ventricular

assist

device

pumps

implantable

intracorporeal

single

ventricle

without

cardiopulmonary

bypass

with

cardiopulmonary

bypass

Insertion

of

ventricular

assist

device

percutaneous

including

radiological

supervision

and

interpretation

arterial

access

only

both

arterial

and

venous

access

with

transseptal

puncture

Removal

of

percutaneous

ventricular

assist

device

at

separate

and

distinct

session

from

insertion

Repositioning

of

percutaneous

ventricular

assist

device

with

imaging

guidance

at

separate

and

distinct

session

from

insertion

Cardioassistmethod

of

circulatory

assist

internal

external

Interrogation

of

ventricular

assist

device

VAD

in

person

with

physician

analysis

of

device

parameters

eg

drivelines

alarms

power

surges

review

of

device

function

eg

flow

volume

status

recovery

with

programming

if

performed

report

CPT

codes

not

covered

for

indications

listed

in

the

CPB

Insertion

or

replacement

of

a

permanently

implantable

aortic

counterpulsation

ventricular

assist

system

endovascular

approach

and

programming

of

sensing

and

therapeutic

parameters

Removal

of

permanently

implantable

aortic

counterpulsation

ventricular

assist

system

Relocation

of

skin

pocket

with

replacement

of

implanted

aortic

counterpulsation

ventricular

assist

device

mechanoelectrical

skin

interface

and

electrodes

Repositioning

of

previously

implanted

aortic

counterpulsation

ventricular

assist

device

Programming

device

evaluation

in

person

with

iterative

adjustment

of

the

implantable

mechanoelectrical

skin

interface

andor

external

driver

to

test

the

function

of

the

device

and

select

optimal

permanent

programmed

values

with

analysis

including

review

and

report

implantable

aortic

counterpulsation

ventricular

assist

system

per

day

Interrogation

device

evaluation

in

person

with

analysis

review

and

report

includes

connection

recording

and

disconnection

per

patient

encounter

implantable

aortic

counterpulsation

ventricular

assist

system

per

day

Bloodderived

hematopoietic

progenitor

cell

harvesting

for

transplantation

per

collection

allogeneic

or

autologous

mesenchymal

precursor

cells

Other

CPT

codes

related

to

the

CPB

Insertion

of

intraaortic

balloon

assist

device

percutaneous

Insertion

of

intraaortic

balloon

assist

device

through

the

femoral

artery

open

approach

Insertion

of

intraaortic

balloon

assist

device

through

the

ascending

aorta

Percutaneous

transluminal

coronary

angioplasty

Percutaneous

transluminal

coronary

atherectomy

Percutaneous

transcatheter

placement

of

intracoronary

stents

with

coronary

angioplasty

when

performed

Percutaneous

transluminal

coronary

atherectomy

with

intracoronary

stent

with

coronary

angioplasty

when

performed

Percutaneous

transluminal

revascularization

of

or

through

coronary

artery

bypass

graft

internal

mammary

free

arterial

venous

any

combination

of

intracoronary

stent

atherectomy

and

angioplasty

including

distal

protection

when

performed

Percutaneous

transluminal

revascularization

of

acute

totalsubtotal

occlusion

during

acute

myocardial

infarction

coronary

artery

or

coronary

artery

bypass

graft

any

combination

of

intracoronary

stent

atherectomy

and

angioplasty

including

aspiration

thrombectomy

when

performed

Percutaneous

transluminal

revascularization

of

chronic

total

occlusion

coronary

artery

coronary

artery

branch

or

coronary

artery

bypass

graft

any

combination

of

intracoronary

stent

atherectomy

and

angioplasty

HCPCS

codes

covered

if

selection

criteria

are

met

Power

module

patient

cable

for

use

with

electric

or

electricpneumatic

ventricular

assist

device

replacement

only

Power

adapter

for

use

with

electric

or

electricpneumatic

ventricular

assist

device

vehicle

type

Power

module

for

use

with

electric

or

electricpneumatic

ventricular

assist

device

replacement

only

Driver

for

use

with

pneumatic

ventricular

assist

device

replacement

only

Microprocessor

control

unit

for

use

with

electric

ventricular

assist

device

replacement

only

Microprocessor

control

unit

for

use

with

electricpneumatic

combination

ventricular

assist

device

replacement

only

Monitordisplay

module

for

use

with

electric

ventricular

assist

device

replacement

only

Monitordisplay

module

for

use

with

electric

or

electricpneumatic

ventricular

assist

device

replacement

only

Monitor

control

cable

for

use

with

electric

ventricular

assist

device

replacement

only

Monitor

control

cable

for

use

with

electricpneumatic

ventricular

assist

device

replacement

only

Leads

pneumaticelectrical

for

use

with

any

type

electricpneumatic

ventricular

assist

device

replacement

only

Power

pack

base

for

use

with

electric

ventricular

assist

device

replacement

only

Power

pack

base

for

use

with

electricpneumatic

ventricular

assist

device

replacement

only

Emergency

power

source

for

use

with

electric

ventricular

assist

device

replacement

only

Emergency

power

source

for

use

with

electricpneumatic

ventricular

assist

device

replacement

only

Emergency

power

supply

cable

for

use

with

electric

ventricular

assist

device

replacement

only

Emergency

power

supply

cable

for

use

with

electricpneumatic

ventricular

assist

device

replacement

only

Emergency

hand

pump

for

use

with

electricpneumatic

ventricular

assist

device

replacement

only

Battery

power

pack

charger

for

use

with

electric

or

electricpneumatic

ventricular

assist

device

replacement

only

Battery

other

than

lithiumion

for

use

with

electric

or

electricpneumatic

ventricular

assist

device

replacement

only

Battery

clip

for

use

with

electric

or

electricpneumatic

ventricular

assist

device

replacement

only

Holster

for

use

with

electric

or

electricpneumatic

ventricular

assist

device

replacement

only

Beltvestbag

for

use

to

carry

external

peripheral

components

of

any

type

ventricular

assist

device

replacement

Filters

for

use

with

electric

or

electricpneumatic

ventricular

assist

device

replacement

only

Shower

cover

for

use

with

electric

or

electricpneumatic

ventricular

assist

device

replacement

only

Mobility

cart

for

pneumatic

ventricular

assist

device

replacement

only

Battery

for

pneumatic

ventricular

assist

device

replacement

only

each

Power

adapter

for

pneumatic

ventricular

assist

device

replacement

only

vehicle

type

Battery

lithiumion

for

use

with

electric

or

electricpneumatic

ventricular

assist

device

replacement

only

Miscellaneous

supply

or

accessory

for

use

with

an

external

ventricular

assist

device

Miscellaneous

supply

or

accessory

for

use

with

an

implanted

ventricular

assist

device

Miscellaneous

supply

or

accessory

for

use

with

any

implanted

ventricular

assist

device

for

which

payment

was

not

made

under

Medicare

Part

A

Other

HCPCS

codes

related

to

the

CPB

Home

infusion

therapy

sympathomimeticinotropic

agent

infusion

therapy

eg

Dobutamine

administrative

services

professional

pharmacy

services

care

coordination

all

necessary

supplies

and

equipment

drugs

and

nursing

visits

coded

separately

per

diem

codes

covered

if

selection

criteria

are

met

Certain

current

complications

following

ST

elevation

STEMI

and

nonST

elevation

NSTEMI

myocardial

infarction

within

the

day

period

Heart

failure

Postcardiotomy

syndrome

Postprocedural

cardiac

insufficiency

following

cardiac

surgery

Postprocedural

cardiac

arrest

following

cardiac

surgery

Postprocedural

heart

failure

following

cardiac

surgery

Other

postprocedural

cardiac

functional

disturbances

following

cardiac

surgery

Cardiogenic

shock

Other

specified

complication

of

cardiac

prosthetic

devices

implants

and

grafts

Other

complications

of

heart

transplant

Awaiting

organ

transplant

status

awaiting

heart

transplant

Presence

of

heart

assist

device

The

above

policy

is

based

on

the

following

references

Bank

AJ

Mir

SH

Nguyen

DQ

et

al

Effects

of

left

ventricular

assist

devices

on

outcomes

in

patients

undergoing

heart

transplantation

Ann

Thorac

Surg

Wessex

Institute

for

Health

Research

and

Development

Development

and

Evaluation

Committee

Left

ventricular

assist

devices

LVADs

for

end

stage

heart

failure

Development

and

Evaluation

Committee

Report

Southampton

UK

Wessex

Institute

Magovern

GJ

Park

SB

Maher

TD

Use

of

a

centrifugal

pump

without

anticoagulants

for

postoperative

left

ventricular

assist

World

J

Surg

Pennington

DG

McBride

LR

Swartz

MT

et

al

Use

of

the

PierceDonachy

ventricular

assist

device

in

patients

with

cardiogenic

shock

after

cardiac

operation

Ann

Thorac

Surg

AbouAwdi

NL

Frazier

OH

The

HeartMate

A

left

ventricular

assist

device

as

a

bridge

to

cardiac

transplantation

Transplant

Proc

Farrar

DJ

Hill

JD

Gray

LA

et

al

Heterotopic

prosthetic

ventricles

as

a

bridge

to

cardiac

transplantation

N

Engl

J

Med

Miller

LW

Mechanical

assist

devices

in

intensive

cardiac

care

Am

Heart

J

Ott

RA

Mills

TC

Eugene

J

Gazzanga

AB

Clinical

choices

for

circulatory

assist

devices

ASAIO

Transactions

Park

SB

Liebler

GA

Burkholder

JA

et

al

Mechanical

support

of

the

failing

heart

Ann

Thorac

Surg

Pennington

DG

Burnhard

WF

Golding

LR

et

al

Longterm

followup

of

postcardiotomy

patients

with

profound

cardiogenic

shock

treated

with

ventricular

assist

devices

Circulation

Criteria

Committee

of

the

New

York

Heart

Association

Nomenclature

and

Criteria

for

Diagnosis

of

Diseases

of

the

Heart

and

Great

Vessels

ed

Boston

MA

Little

Brown

McCarthy

PM

HeartMate

implantable

left

ventricular

assist

device

Bridge

to

transplantation

and

future

applications

Ann

Thoarc

Surg

Portner

PM

Oyer

PE

Pennington

DG

et

al

Implantable

electrical

left

ventricular

assist

system

Bridge

to

transplantation

and

the

future

Ann

Thorac

Surg

Kanter

KR

McBride

LR

Pennington

G

Bridging

to

cardiac

transplantation

with

pulsatile

ventricular

assist

devices

Ann

Thorac

Surg

Reedy

JE

Swartz

MT

Termuhlen

DF

et

al

Bridge

to

heart

transplantation

Importance

of

patient

selection

J

Heart

Transplant

Hunt

SA

Commentthe

REMATCH

trial

Longterm

use

of

a

left

ventricular

assist

device

for

endstage

heart

failure

J

Card

Fail

Rose

EA

Gelijns

AC

Moskowitz

AJ

et

al

Longterm

mechanical

left

ventricular

assistance

for

endstage

heart

failure

N

Engl

J

Med

Alpert

JS

Left

ventricular

assist

devices

reduced

the

risk

for

death

and

increased

survival

in

chronic

endstage

heart

failure

ACP

J

Club

LAgence

Nationale

dAccreditation

dEvaluation

en

Sante

ANAES

Evaluation

of

ventricular

assist

as

a

bridge

to

heart

transplant

or

as

destination

therapy

Paris

France

ANAES

Institute

for

Clinical

Systems

Improvement

ICSI

Left

ventricular

assist

devices

as

permanent

implants

Bloomington

MN

ICSI

Kherani

AR

Oz

MC

Ventricular

assistance

to

bridge

to

transplantation

Surg

Clin

North

Am

viiiix

Mundy

L

Merlin

T

Thoratec

heartmate

R

left

ventricular

assist

device

for

patients

with

heart

failure

who

are

ineligible

for

heart

transplantation

Horizon

Scanning

Prioritising

Summary

Volume

Adelaide

SA

Adelaide

Health

Technology

Assessment

AHTA

on

behalf

of

National

Horizon

Scanning

Unit

HealthPACT

and

MSAC

Westaby

S

Ventricular

assist

devices

as

destination

therapy

Surg

Clin

North

Am

Ontario

Ministry

of

Health

and

LongTerm

Care

Medical

Advisory

Secretariat

Left

ventricular

assist

devices

Health

Technology

Scientific

Literature

Review

Toronto

ON

Ontario

Ministry

of

Health

and

LongTerm

Care

updated

March

BlueCross

BlueShield

Association

BCBSA

Technology

Evaluation

Center

TEC

Special

report

Costeffectiveness

of

leftventricular

assist

devices

as

destination

therapy

for

endstage

heart

failure

TEC

Assessment

Program

Chicago

IL

BCBSA

April

Available

at

Accessed

October

Clegg

AJ

Scott

DA

Loveman

E

et

al

The

clinical

and

costeffectiveness

of

left

ventricular

assist

devices

for

endstage

heart

failure

A

systematic

review

and

economic

evaluation

Health

Technol

Assess

Sharples

L

Buxton

M

Caine

N

et

al

Evaluation

of

the

ventricular

assist

device

programme

in

the

UK

Health

Technol

Assess

Hetzer

R

Stiller

B

Technology

insight

Use

of

ventricular

assist

devices

in

children

Nat

Clin

Pract

Cardiovasc

Med

Clegg

AJ

Scott

DA

Loveman

E

et

al

Clinical

and

costeffectiveness

of

left

ventricular

assist

devices

as

a

bridge

to

heart

transplantation

for

people

with

endstage

heart

failure

A

systematic

review

and

economic

evaluation

Eur

Heart

J

Clegg

AJ

Scott

DA

Loveman

E

et

al

Clinical

and

costeffectiveness

of

left

ventricular

assist

devices

as

destination

therapy

for

people

with

endstage

heart

failure

A

systematic

review

and

economic

evaluation

Int

J

Technol

Assess

Health

Care

Miller

LW

Pagani

FD

Russell

SD

et

al

HeartMate

II

Clinical

Investigators

Use

of

a

continuousflow

device

in

patients

awaiting

heart

transplantation

N

Engl

J

Med

Bastardi

HJ

Naftel

DC

Webber

SA

et

al

Ventricular

assist

devices

as

a

bridge

to

heart

transplantation

in

children

J

Cardiovasc

Nurs

Esmore

D

Kaye

D

Spratt

P

et

al

A

prospective

multicenter

trial

of

the

VentrAssist

left

ventricular

assist

device

for

bridge

to

transplant

Safety

and

efficacy

J

Heart

Lung

Transplant

Rajdev

S

Krishnan

P

Irani

A

et

al

Clinical

application

of

prophylactic

percutaneous

left

ventricular

assist

device

TandemHeart

in

highrisk

percutaneous

coronary

intervention

using

an

arterial

preclosure

technique

Singlecenter

experience

J

Invasive

Cardiol

Vranckx

P

Meliga

E

De

Jaegere

PP

et

al

The

TandemHeart

percutaneous

transseptal

left

ventricular

assist

device

A

safeguard

in

highrisk

percutaneous

coronary

interventions

The

sixyear

Rotterdam

experience

EuroIntervention

AlHusami

W

Yturralde

F

Mohanty

G

et

al

Singlecenter

experience

with

the

TandemHeart

percutaneous

ventricular

assist

device

to

support

patients

undergoing

highrisk

percutaneous

coronary

intervention

J

Invasive

Cardiol

Vecchio

S

Chechi

T

Giuliani

G

et

al

Use

of

Impella

Recover

left

ventricular

assist

device

in

patients

with

cardiogenic

shock

or

undergoing

highrisk

percutaneous

coronary

intervention

procedures

Experience

of

a

highvolume

center

Minerva

Cardioangiol

Seyfarth

M

Sibbing

D

Bauer

I

et

al

A

randomized

clinical

trial

to

evaluate

the

safety

and

efficacy

of

a

percutaneous

left

ventricular

assist

device

versus

intraaortic

balloon

pumping

for

treatment

of

cardiogenic

shock

caused

by

myocardial

infarction

J

Am

Coll

Cardiol

Lam

K

Sjauw

KD

Henriques

JP

et

al

Improved

microcirculation

in

patients

with

an

acute

STelevation

myocardial

infarction

treated

with

the

Impella

percutaneous

left

ventricular

assist

device

Clin

Res

Cardiol

Dixon

SR

Henriques

JP

Mauri

L

et

al

A

prospective

feasibility

trial

investigating

the

use

of

the

Impella

system

in

patients

undergoing

highrisk

percutaneous

coronary

intervention

The

PROTECT

I

Trial

Initial

US

experience

JACC

Cardiovasc

Interv

Granfeldt

H

Hellgren

L

Dellgren

G

et

al

Experience

with

the

Impella

recovery

axialflow

system

for

acute

heart

failure

at

three

cardiothoracic

centers

in

Sweden

Scand

Cardiovasc

J

Hermansen

SE

Naesheim

T

How

OJ

Myrmel

T

Circulatory

assistance

in

acute

heart

failure

where

do

we

go

from

here

Scand

Cardiovasc

J

OConnor

E

Fraser

JF

How

can

we

prevent

and

treat

cardiogenic

shock

in

patients

who

present

to

nontertiary

hospitals

with

myocardial

infarction

A

systematic

review

Med

J

Aust

Cheng

JM

den

Uil

CA

Hoeks

SE

et

al

Percutaneous

left

ventricular

assist

devices

vs

intraaortic

balloon

pump

counterpulsation

for

treatment

of

cardiogenic

shock

A

metaanalysis

of

controlled

trials

Eur

Heart

J

Esfandiari

S

Erickson

L

McGregor

M

The

Impella

percutaneous

ventricular

assist

device

Report

No

Montreal

QC

Technology

Assessment

Unit

of

the

McGill

University

Health

Centre

MUHC

June

Slaughter

MS

Rogers

JG

Milano

CA

et

al

HeartMate

II

Investigators

Advanced

heart

failure

treated

with

continuousflow

left

ventricular

assist

device

N

Engl

J

Med

Sjauw

KD

Konorza

T

Erbel

R

et

al

Supported

highrisk

percutaneous

coronary

intervention

with

the

Impella

device

the

Europella

registry

J

Am

Coll

Cardiol

US

Food

and

Drug

Administration

FDA

Thoratec

HeartMate

II

left

ventricular

assist

system

LVAS

Summary

of

Safety

and

Effectiveness

Data

Premarket

Approval

Application

PMA

No

Silver

Spring

MD

FDA

April

US

Food

and

Drug

Administration

FDA

CentriMag

Right

Ventricular

Assist

System

RVAS

Summary

of

Safety

and

Probable

Benefit

Humanitarian

Device

Exemption

No

Silver

Spring

MD

FDA

October

US

Food

and

Drug

Administration

FDA

Impella

Recover

LP

Percutaneous

Cardiac

Support

System

Summary

Silver

Spring

MD

FDA

May

US

Food

and

Drug

Administration

FDA

Impella

Summary

Silver

Spring

MD

FDA

April

US

Food

and

Drug

Administration

FDA

FDA

approves

left

ventricular

assist

system

for

severe

heart

failure

patients

Device

provides

support

for

those

who

are

not

acceptable

transplant

candidates

FDA

News

Silver

Spring

MD

FDA

January

Available

at

Accessed

July

Sarkar

K

Kini

AS

Percutaneous

left

ventricular

support

devices

Cardiol

Clin

Shuhaiber

JH

Hur

K

Gibbons

R

The

influence

of

preoperative

use

of

ventricular

assist

devices

on

survival

after

heart

transplantation

Propensity

score

matched

analysis

BMJ

Kormos

RL

Teuteberg

JJ

Pagani

FD

et

al

HeartMate

II

Clinical

Investigators

Right

ventricular

failure

in

patients

with

the

HeartMate

II

continuousflow

left

ventricular

assist

device

Incidence

risk

factors

and

effect

on

outcomes

J

Thorac

Cardiovasc

Surg

Centers

for

Medicare

Medicaid

Services

CMS

Decision

memo

for

ventricular

assist

devices

as

destination

therapy

Medicare

Coverage

Database

Baltimore

MD

CMS

AvioMed

Inc

PROTECT

II

A

Prospective

Multicenter

Randomized

Controlled

Trial

of

the

IMPELLA

RECOVER

LP

System

Versus

Intra

Aortic

Balloon

Pump

in

Patients

Undergoing

Non

Emergent

High

Risk

PCI

trial

ClinicalTrialsgov

Identifier

Bethesda

MD

National

Library

of

Medicine

updated

March

Available

at

Accessed

July

Abiomed

Inc

Abiomed

announces

final

PROTECT

II

study

results

for

highrisk

PCI

patient

population

at

American

College

of

Cardiology

scientific

sessions

Press

Release

Danvers

MA

Abiomed

April

Levine

GN

Bates

ER

Blankenship

JC

et

al

ACCFAHASCAI

Guideline

for

Percutaneous

Coronary

Intervention

A

report

of

the

American

College

of

Cardiology

FoundationAmerican

Heart

Association

Task

Force

on

Practice

Guidelines

and

the

Society

for

Cardiovascular

Angiography

and

Interventions

Circulation

John

R

Liao

K

Lietz

K

et

al

Experience

with

the

Levitronix

CentriMag

circulatory

support

system

as

a

bridge

to

decision

in

patients

with

refractory

acute

cardiogenic

shock

and

multisystem

organ

failure

J

Thorac

Cardiovasc

Surg

Shuhaiber

JH

Jenkins

D

Berman

M

et

al

The

Papworth

experience

with

the

Levitronix

CentriMag

ventricular

assist

device

J

Heart

Lung

Transplant

De

Robertis

F

Rogers

P

Amrani

M

et

al

Bridge

to

decision

using

the

Levitronix

CentriMag

shortterm

ventricular

assist

device

J

Heart

Lung

Transplant

US

Food

and

Drug

Administration

FDA

FDA

approves

use

of

temporary

pump

to

assist

hearts

right

side

FDA

News

Silver

Spring

MD

FDA

October

Available

at

Accessed

March

Krabatsch

T

Schweiger

M

Stepanenko

A

et

al

Improvements

in

implantable

mechanical

circulatory

support

systems

Literature

overview

and

update

Herz

Sharma

MS

Forbess

JM

Guleserian

KJ

Ventricular

assist

device

support

in

children

and

adolescents

with

heart

failure

The

Childrens

Medical

Center

of

Dallas

experience

Artif

Organs

Rossi

M

Serraino

GF

Jiritano

F

Renzulli

A

What

is

the

optimal

anticoagulation

in

patients

with

a

left

ventricular

assist

device

Interact

Cardiovasc

Thorac

Surg

Fraser

CD

Jr

Jaquiss

RD

Rosenthal

DN

et

al

Berlin

Heart

Study

Investigators

Prospective

trial

of

a

pediatric

ventricular

assist

device

N

Engl

J

Med

US

Food

and

Drug

Administration

FDA

EXCOR

Pediatric

Ventricular

Assist

Device

Summary

of

Safety

and

Probable

Benefit

Humanitarian

Use

Device

Exemption

No

Silver

Spring

MD

FDA

December

US

Food

and

Drug

Administration

FDA

HeartWare

Ventricular

Assist

System

Summary

of

Safety

and

Effectiveness

Data

SSED

Premarket

Approval

Application

PMA

No

Silver

Spring

MD

FDA

November

Almond

CS

Morales

DL

Blackstone

EH

et

al

Berlin

Heart

EXCOR

pediatric

ventricular

assist

device

for

bridge

to

heart

transplantation

in

US

children

Circulation

ECRI

Institute

Pediatric

ventricular

assist

device

Excor

for

pediatric

endstage

heart

failure

In

AHRQ

Healthcare

Horizon

Scanning

System

Potential

HighImpact

Interventions

Priority

Area

Cardiovascular

Prepared

by

ECRI

Institute

under

Contract

No

Rockville

MD

Agency

for

Healthcare

Research

and

Quality

June

Sutcliffe

P

Connock

M

PulikottilJacob

R

et

al

Clinical

effectiveness

and

costeffectiveness

of

second

and

thirdgeneration

left

ventricular

assist

devices

as

either

bridge

to

transplant

or

alternative

to

transplant

for

adults

eligible

for

heart

transplantation

Systematic

review

and

costeffectiveness

model

Health

Technol

Assess

vvi

Eghtesady

P

Almond

CS

Tjossem

C

et

al

Posttransplant

outcomes

of

children

bridged

to

transplant

with

the

Berlin

Heart

EXCOR

Pediatric

ventricular

assist

device

Circulation

Suppl

Boothroyd

LJ

Lambert

LJ

Sas

G

et

al

Should

eligibility

for

heart

transplantation

be

a

requirement

for

left

ventricular

assist

device

use

Recommendations

based

on

a

systematic

review

Can

J

Cardiol

Lemaire

A

Anderson

MB

Lee

LY

et

al

The

Impella

device

for

acute

mechanical

circulatory

support

in

patients

in

cardiogenic

shock

Ann

Thorac

Surg

Ascheim

DD

Gelijns

AC

Goldstein

D

et

al

Mesenchymal

precursor

cells

as

adjunctive

therapy

in

recipients

of

contemporary

left

ventricular

assist

devices

Circulation

Takeda

K

Naka

Y

Yang

JA

et

al

Outcome

of

unplanned

right

ventricular

assist

device

support

for

severe

right

heart

failure

after

implantable

left

ventricular

assist

device

insertion

J

Heart

Lung

Transplant

Baumann

Kreuziger

LM

Kim

B

Wieselthaler

GM

Antithrombotic

therapy

for

left

ventricular

assist

devices

in

adults

A

systematic

review

J

Thromb

Haemost

US

Food

and

Drug

Administration

FDA

Impella

System

Summary

of

Safety

and

Effectiveness

Data

SSED

Premarket

Approval

Application

PMA

No

Silver

Spring

MD

FDA

March

US

Food

and

Drug

Administration

FDA

Impella

RP

System

Summary

of

Safety

and

Probable

Benefit

Humanitarian

Device

Exemption

HDE

No

Silver

Spring

MD

FDA

January

Yancy

CW

Jessup

M

Bozkurt

B

et

al

American

College

of

Cardiology

Foundation

American

Heart

Association

Task

Force

on

Practice

Guidelines

ACCFAHA

guideline

for

the

management

of

heart

failure

A

report

of

the

American

College

of

Cardiology

FoundationAmerican

Heart

Association

Task

Force

on

Practice

Guidelines

J

Am

Coll

Cardiol

Francis

GS

Greenberg

BH

Hsu

DT

et

al

ACCFAHAACP

Task

Force

ACCFAHAACPHFSAISHLT

clinical

competence

statement

on

management

of

patients

with

advanced

heart

failure

and

cardiac

transplant

A

report

of

the

ACCFAHAACP

Task

Force

on

Clinical

Competence

and

Training

J

Am

Coll

Cardiol

Peura

JL

ColvinAdams

M

Francis

GS

et

al

American

Heart

Association

Heart

Failure

and

Transplantation

Committee

of

the

Council

on

Clinical

Cardiology

Council

on

Cardiopulmonary

Critical

Care

Perioperative

and

Resuscitation

Council

on

Cardiovascular

Disease

in

the

Young

Council

on

Cardiovascular

Nursing

Council

on

Cardiovascular

Radiology

and

Intervention

and

Council

on

Cardiovascular

Surgery

and

Anesthesia

Recommendations

for

the

use

of

mechanical

circulatory

support

Device

strategies

and

patient

selection

A

scientific

statement

from

the

American

Heart

Association

Circulation

Acker

MA

Pagani

FD

Stough

WG

et

al

Statement

regarding

the

pre

and

post

market

assessment

of

durable

implantable

ventricular

assist

devices

in

the

United

States

Executive

summary

Circ

Heart

Fail

Kirk

R

Dipchand

AI

Rosenthal

DN

et

al

The

International

Society

for

Heart

and

Lung

Transplantation

Guidelines

for

the

management

of

pediatric

heart

failure

Executive

summary

Corrected

J

Heart

Lung

Transplant

Feldman

D

Pamboukian

SV

Teuteberg

JJ

et

al

International

Society

for

Heart

and

Lung

Transplantation

The

International

Society

for

Heart

and

Lung

Transplantation

Guidelines

for

mechanical

circulatory

support

Executive

summary

J

Heart

Lung

Transplant

Heart

Failure

Society

of

America

Lindenfeld

J

Albert

NM

Boehmer

JP

et

al

HFSA

Comprehensive

Heart

Failure

Practice

Guideline

J

Card

Fail

StempienOtero

A

Helterline

D

Plummer

T

et

al

Mechanisms

of

bone

marrowderived

cell

therapy

in

ischemic

cardiomyopathy

with

left

ventricular

assist

device

bridge

to

transplant

J

Am

Coll

Cardiol

Baumann

Kreuziger

LM

Kim

B

Wieselthaler

GM

Antithrombotic

therapy

for

left

ventricular

assist

devices

in

adults

A

systematic

review

J

Thromb

Haemost

Health

Quality

Ontario

Left

ventricular

assist

devices

for

destination

therapy

A

health

technology

assessment

Ont

Health

Technol

Assess

Ser

Briasoulis

A

Telila

T

Palla

M

et

al

Metaanalysis

of

usefulness

of

percutaneous

left

ventricular

assist

devices

for

highrisk

percutaneous

coronary

interventions

Am

J

Cardiol

Jeevanandam

V

Jayakar

D

Anderson

AS

et

al

Circulatory

assistance

with

a

permanent

implantable

IABP

Initial

human

experience

Circulation

Suppl

Russo

MJ

Jeevanandam

V

Stepney

J

et

al

Intraaortic

balloon

pump

inserted

through

the

subclavian

artery

A

minimally

invasive

approach

to

mechanical

support

in

the

ambulatory

endstage

heart

failure

patient

J

Thorac

Cardiovasc

Surg

Estep

JD

CorderoReyes

AM

Bhimaraj

A

et

al

Percutaneous

placement

of

an

intraaortic

balloon

pump

in

the

left

axillarysubclavian

position

provides

safe

ambulatory

longterm

support

as

bridge

to

heart

transplantation

JACC

Heart

Fail

Tanaka

A

Tuladhar

SM

Onsager

D

et

al

The

subclavian

intraaortic

balloon

pump

A

compelling

bridge

device

for

advanced

heart

failure

Ann

Thorac

Surg

discussion

Cecere

R

Dowling

RD

Giannetti

N

Initial

clinical

experience

with

the

Symphony

heart

assist

system

Ann

Thorac

Surg

Aroesty

JM

Jeevanandam

V

Eisen

HJ

Shortterm

mechanical

circulatory

assist

devices

Uptodate

Inc

Waltham

MA

Last

reviewed

December

Medtronic

Inc

Medtronic

HeartWare

HVAD

system

approved

for

destination

therapy

Press

Release

Dublin

Ireland

Medtronic

September

Neale

T

FDA

grants

HeartWare

LVAD

a

destination

therapy

indication

News

Release

New

York

NY

TCTMD

September

Available

at

httpswwwtctmdcomnewsfdagrantsheartwarelvaddestinationtherapyindication

Accessed

October

Rogers

JG

Pagani

FD

Tatooles

AJ

et

al

Intrapericardial

left

ventricular

assist

device

for

advanced

heart

failure

N

Engl

J

Med

US

Food

and

Drug

Administration

FDA

Thoratec

HeartMate

Left

Ventricular

Assist

System

Premarket

Approval

Application

PMA

No

Silver

Spring

MD

FDA

August

Available

at

Marcuschamer

IA

Abelow

A

Kornowski

R

The

evolving

role

of

percutaneous

ventricular

assist

devices

in

highrisk

cardiac

patients

Coron

Artery

Dis

Health

Quality

Ontario

Percutaneous

ventricular

assist

devices

A

health

technology

assessment

Ont

Health

Technol

Assess

Ser

Bansal

N

Hailpern

SM

Katz

R

et

al

Outcomes

associated

with

left

ventricular

assist

devices

among

recipients

with

and

without

endstage

renal

disease

JAMA

Intern

Med

Huang

JY

Monagle

P

Massicotte

MP

VanderPluym

CJ

Antithrombotic

therapies

in

children

on

durable

ventricular

assist

devices

A

literature

review

Thromb

Res

Feb

Epub

ahead

of

print

Ogunbayo

GO

Ha

LD

Ahmad

Q

et

al

Inhospital

outcomes

of

percutaneous

ventricular

assist

devices

versus

intraaortic

balloon

pumps

in

nonischemia

related

cardiogenic

shock

Heart

Lung

Apr

Epub

ahead

of

print

Zhigalov

K

Mashhour

A

Szczechowicz

M

et

al

Clinical

outcome

and

comparison

of

three

different

left

ventricular

assist

devices

in

a

highrisk

cohort

Artif

Organs

May

Epub

ahead

of

print

B I I O O O O O O O O O O B I O B I I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O B I I O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O 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O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O 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O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I I O O O O O O O O O O O O O O O O O O O O O O O O O O B I I I O O O O O O O O O O O O O O O O O O O O B I I I O O O O O O O O O O O O O O B I I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I I O O O O O O O O O O O O O O O O O O O O O O O O O O B I I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O B I I I O O O O O O O O O O O O O O O O O O O O O O O O O B I I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B 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aetna considers
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Online Resources Online Resources AFCO Online Resources Training We have several online training modules available to our customers as part of our service Each module requires your associates to complete required goals and passing a comprehension quiz to receive a certificate of completion We have the capability to create custom training specific to your company Documentation If your goal is unrestricted access to your SSOPs Master Sanitation procedures or forms and check sheets consider AFCO online sanitation program We have the capability to host your program online

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We Manufacture standard custom products for the residential industrial market Get A Quote NOW Fencing Cape Town Afriwire and Steel Afriwire and Steel Pty Ltd is a wellrespected company that specializes in the supply and manufacture of fencing products in the steel engineering industry The Afriwire factory and sales office is situated in the Bellville CBD Area We serve both the local and export markets We pride ourselves in delivering excellent service and good value for our clients Navigation Balustrading Bar Fencing Wire Mesh Internal Partitioning Palisade Razor Wire Ready Fence Panels Securiy Mesh Spikes Gates Gate Automation Fencing Materials Contact Details 086 023 7494 Share Call 021 945 1717 021 945 1716 salesafriwirecoza 13 Tedric Street Stikland Industrial 7530 Enquiry Enquiry 1 1

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Loading similar games Annabelle Mysteries Escape Asylum Game Five Nights at Freddys Madalin Stunt Cars 2 MahJongCon Fireboy Watergirl 3 The Ice Temple Uphill Rush 7 Waterpark Dark Chocolate Blackberry Cheesecake Saras Cooking Class Scary Maze TextTwist 2 Mind Game The Princess Sent to the Future Dress Up Game True Love Calculator Fireboy Watergirl 4 Crystal Temple Fidget Spinner Jessica the Youtuber Slitherio Euro Soccer Forever Goalkeeper Italian Football Game Wormaxio The Handy Man Sniper Game Uphill Rush SuperhexIo Theme Hotel Graffiti Time Money Movers A New Beginning From Sad To Fab KULI Zombie Gun Game The Strangers Papas Freezeria Plants vs Zombies Free Flight Sim 3D Airplane Simulator Game Troll Face Quest Video Games I Dont Even Know Red Ball Geometry Neon Dash Subzero Wormateio Geometry Neon Dash Ellie Get Ready With Me Snail Bob 6 Winter Story Army Recoup Island Survival Game Country Ride Race Car Game Five Nights at Freddys 2 Clown Nights Popstar Dentist Family Barn Bubble Shooter Chucky 33 I dont like it 67 I like it Description Help Chucky get across the river by keeping him bouncing off the paddle How to play Chucky Use the mouse to play this game Home Skill Platform Games Arcade Friv Games Girls Platform Games Skill Need help watch our Walkthrough for this game Tell us what you think about Chucky Leave a review or share a tip You need to be signed in to post a comment or

O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O


Power Cost Equalization New Online PCE reporting coming soon In response to concerns raised by rural utilities about the need for faster payment processing and more simplified reporting AEA has developed an online PCE reporting portal Starting in July AEA will be working closely with a small handful of utilities to test the new portal After the testing period is complete any needed improvements and adjustments will be made before rolling it out in the winter for other interested utilities in a waved approach This new tool will be an option for utilities it will not be mandatory The PCE Web Portal will allow utilities to submit monthly reports directly to a form on the web Benefits of the portal include easier submission of the PCE reports savings on postage a faster turnaround for payment and convenient access to historic UMRs in digital form Any questions regarding the new web portal should be directed to Jeff Williams PCE Program Manager jwilliamsakenergyauthorityorg by dialing toll free at 888 3008534 or directly at 907 7713929 PCE Overview PCE Reports PCE Publications PCE Training Video PCE Program Fact Sheet The goal of Alaska Energy Authoritys AEA Power Cost Equalization program is to provide economic assistance to customers in rural areas of Alaska where the kilowatthour charge for electricity can be three to five times higher than the charge in more urban areas of the state Approximately 30 of all kWhs sold by the participating utilities are eligible for PCE PCE fundamentally improves Alaskas standard of living by helping small rural areas maintain the availability of communications and the operation of basic infrastructure and systems including water and sewer incinerators heat and light PCE is a core element underlying the financial viability of centralized power generation in rural communities The Legislature established different functions for AEA and the Regulatory Commission of Alaska RCA under Alaska Statutes 4245100170 which govern PCE program responsibilities AEA determines eligibility of community facilities and residential customers and authorizes payment to the electric utility Commercial customers are not eligible to receive PCE credit Participating utilities are required to reduce each eligible customers bill by the amount that the State pays for PCE RCA determines if a utility is eligible to participate in the program and calculates the amount of PCE per kWh payable to the utility More information about the RCA may be found at wwwstateakusrca Power Cost Equalization Program Guide PCE Program Statutes AS 4245110 PCE Eligibility and Certification Determination Request Form For more information contact Jeff Williams PCE Program Manager Community Assistance Tel 907 7713929 Fax 907 7713044 PCE Web Portal

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Model ALL200 ALL200 200 lbs Maximum Fixture Weight Residential Grade Standard Mount UL Listed Contact your local lighting and electrical store or use our dealer locator Find a Dealer Near You Specs Options InstallationDocuments 200lbs maximum capacity Keyswitch Controller 35 winch cable 1650 watt light wattage capacity 110 volt Mounts directly above fixture at least 3 vertical access space recommended 14 wide x 19 long x 9 high mounted on two 36 channel struts Plastic dust cover Romex wire 50 Controller wire UL Listed

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About Us AlAhli Tadawul Research AlAhli Online Careers Contact Us Advanced NCB Capital Individuals Institutions Customer Service NCBC Tools Research Library Margin Trading Apply now for Margin Trading online Margin Trading Open an Investment Account Online Listed Companies Symbols Mutual Funds Alahli Tadawul News NCB Capital Company announces the implementation of Significant Changes in AlAhli MultiAsset 30 December 2018 NCB Capital Company announces the implementation of the Significant Changes in AlAhli MultiAsset Moderate Fund AlAhli MultiAsset Growth Fund and AlAhli Global Equity Fund announced on 20 Rabea I 1440H موافقة هيئة السوق المالية بزيادة رأس مال شركة أمانة للتأمين التعاوني عن طريق طرح أسهم حقوق أولوية 13 December 2018 أعلنت هيئة السوق المالية الهيئة في تاريخ 27031440 هـ الموافق 06112018 صدور قرارها المتضمن بالموافقة على طلب شركة أمانة للتأمين التعاوني الشركة بخصوص زيادة رأس مالها عن طريق طرح أسهم حقوق أولوية بقيمة Media Petrochemical Companies Quarterly Results 28 January 2018 Interview with Iyad Ghulam NCB Capitals Equity Research Analyst discussing petrochemical companies quarterly results Almarais earnings results 21 January 2018 Interview with Mohamed Tomalieh NCB Capitals Equity Research Analyst discussing Almarais earnings results

O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O


Whats new 08062018 10 YEARS OF ALCO BIO FUEL Alco Bio Fuel proudly celebrates its 10 years operations from an ethanol DDGS plant to a stateofthe art bio refinery And we will not stop here read more on our press release welcome to alco bio fuel Alco Bio Fuel is one of Belgiums major biorefineries processing grain mostly corn and wheat into bioethanol proteinrich feed DDGS electricity liquid CO2 and a number of other byproducts corn oil etc It is a joint partnership between Alcogroup the Brussels based ethanol production and trading company Vanden Avenne Izegem grain and derivatives trading and storage AVEVE and WalAgri Belgiums largest grain receiving group This exceptional collaboration between shareholders of vast experience in all products related to the bioethanol production process has resulted in an excellent bundling of competences necessary to the production of topgrade bioethanol and coproducts Our biorefinery processes all our raw material being feed wheat and corn in a number of added value products Produced from renewable resources bioethanol is a cleanburning fuel that is also a good octane booster Beside bioethanol we also produce DDGS proteinrich animal feed corn oil electricity and liquid CO2

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alco bio fuel
bioethanol production process


What is Media Advocacy Media advocacy is the strategic use of newsmaking through TV radio and newspapers to promote public debate and generate community support for changes in community norms and policies Advocating for the goals of safe healthy and prosperous communities identifying barriers to strategic policy implementation and sharing current research through newsmaking all help policy makers and the general public to more fully engage in creating systemic changes that improve the world we live in Members of the general public are the ultimate decisionmakers and opinion leaders in our society Community attitudes beliefs norms and practices are shaped by the dialogues that take place within families and the social networks we experience in our everyday lives The manner in which policy makers and the public understand and resolve the challenges faced by communities in todays world is guided by the quality of information available to them The news media as a primary source of information play a very powerful role in shaping the public dialogues that eventually form community rules and standards Background Information on Media Advocacy Index return to Media Advocacy index

O O B I B I O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O B I O