Spanish

health

benefits

for

services

of

curative

care

This

contribution

presents

entitlements

and

benefits

decision

criteria

and

involved

actors

for

services

of

curative

care

in

Spain

It

describes

basic

benefits

included

in

the

category

of

curative

care

defined

by

the

central

government

and

any

additional

benefits

that

some

autonomous

communities

-LRB-

ACs

-RRB-

have

included

to

enlarge

their

own

basket

It

is

concluded

that

there

is

no

specific

and

explicit

benefit

catalogue

As

no

user

charges

exist

for

this

category

waiting

times

serve

as

the

main

cost

containment

tool

There

is

a

need

for

further

legislation

as

inequalities

may

increase

across

the

territory

as

a

matter

of

fact

Inequalities

in

access

to

health

care

resources

between

ACs

are

not

due

to

differences

in

health

baskets

but

mainly

to

the

availability

of

technologies

The

principal

actors

responsible

for

defining

of

benefit

catalogues

from

the

services

of

curative

care

in

Spain

are

the

Central

Government

and

the

autonomous

communities

-LRB-

ACs

-RRB-

Law

-LSB-

-RSB-

states

that

the

Spanish

health

benefit

basket

should

serve

as

a

minimum

for

all

Spanish

residents

to

ensure

the

equality

of

access

and

benefits

among

them

irrespective

of

their

location

Nevertheless

as

ACs

may

vary

the

allocation

of

their

funding

some

may

decide

to

offer

additional

or

new

benefits

even

including

those

that

are

explicitly

excluded

on

national

level

by

Royal

Decree

-LSB-

-RSB-

and

Law

The

central

government

's

main

responsibilities

are

as

follows

-LRB-

a

-RRB-

general

coordination

and

basic

health

legislation

-LRB-

b

-RRB-

financing

of

the

system

and

the

regulation

of

the

financial

aspects

of

social

security

-LRB-

c

-RRB-

definition

of

a

benefit

basket

guaranteed

by

the

National

Health

System

-LRB-

NHS

-RRB-

-LRB-

d

-RRB-

international

health

-LRB-

e

-RRB-

pharmaceutical

policy

-LRB-

f

-RRB-

health

professionals

undergraduate

and

postgraduate

training

and

-LRB-

g

-RRB-

human

resources

policies

regarding

civil

servants

A

number

of

ministries

-LRB-

Economy

and

Finance

Public

Administration

Labor

and

Social

Affairs

Education

and

Culture

Environment

Justice

and

Defense

Ministries

-RRB-

share

these

responsibilities

and

therefore

determine

the

health

benefit

basket

although

the

Ministry

of

Health

and

Consumer

Affairs

plays

the

main

role

in

finally

determining

any

health

policies

Regional

governments

-LRB-

ACs

-RRB-

have

the

responsibility

for

planning

financing

and

providing

health

care

services

-LRB-

including

an

enlargement

of

the

basic

health

benefit

basket

-RRB-

social

and

community

care

and

public

health

Another

important

agent

in

coordinating

and

evaluating

new

benefits

is

the

Institute

of

Health

Carlos

III

Local

governments

are

responsible

for

home-based

nursery

and

social

services

Coordination

takes

place

in

the

Inter-Territorial

Council

of

the

NHS

and

advisory

committee

comprising

representatives

from

the

central

and

regional

governments

that

is

responsible

for

ensuring

the

equality

of

benefits

among

and

access

across

regions

The

present

contribution

focuses

on

services

of

curative

care

excluding

services

such

as

rehabilitative

care

and

goods

dispensed

to

outpatients

The

other

categories

have

been

studied

in

a

detailed

report

as

part

of

the

Health

Basket

Project

and

are

presented

in

Tables

and

including

the

benefit

defining

criteria

We

first

present

an

overview

of

the

basic

benefits

that

all

ACs

should

provide

and

describe

the

additional

benefits

that

some

ACs

include

in

their

own

basket

We

then

discuss

the

benefit

catalogues

and

their

actual

implementation.Table

Benefit-defining

laws/decrees

and

catalogues

and

the

implicit

regulation

by

sector

IGeneral

Health

ActRoyal

Decree

Decree

April

Decree

June

Decree

March

categories

HC

HC

HC

HC

HC

HC

HC

HC

HC

HC

HC

HC

HC

HC

HC

HC

Legal

statusLawPresidential

DecreeLawMinistry

DecreeMinistry

DecreeMinistry

DecreeDecision

makerParliamentGovernmentParliamentGovernmentGovernmentGovernmentDegree

of

definition

of

benefitsPPPPPPOriginal

purposeGeneral

definition

of

entitlementsBasketEquality

among

citizens

and

ACsBasketBasketBasketCriteria

used

for

defining

benefits

Need

Costs

Effectiveness

Cost-effectiveness

Budget

UpdatingNoNoNoRegularlyRegularlyRegularlya

all

necessary

areas

of

care

itemsTable

Benefit-defining

laws/decrees

and

catalogues

and

the

implicit

regulation

by

sector

IIGeneral

Health

ActRoyal

D

Decree

Decree

Decree

Decree

January

categories

HC

HC

HC

HC

HC

HC

HC

HC

HC

HC

HC

HC

HC

Legal

statusLawPresidential

DecreeLawLawLawPresidential

DecreePresidential

DecreePresidential

DecreeMinisterial

DecreeDecision

makerParliamentGovernmentParliamentParliamentParliamentGovernmentGovernmentGovernmentGovernmentDegree

of

definition

of

benefitsPPPPPNNNPOriginal

purposeGeneral

definition

of

entitlementBasketEquality

among

citizens

and

ACsGeneral

definition

of

entitlementTarget

ruleExclusionExclusionExclusionBasketCriteria

used

for

defining

benefits

Need

Costs

Effectiveness

Cost-effectiveness

Budget

UpdatingNoNoNoNoNoRegularyRegularyRegularyRegularya

all

necessary

areas

of

care

items

Definition

and

structure

of

the

main

benefit

basket

for

curative

care

With

regards

to

benefit

coverage

the

Spanish

Constitutional

Act

stipulates

Spanish

citizenship

as

the

only

precondition

for

access

to

the

range

of

health

care

benefits

Parliamentary

ratification

on

December

-LSB-

-RSB-

extended

coverage

to

the

entire

resident

population

The

major

differences

between

ACs

are

related

to

foreigners

The

fundamental

act

on

health

benefit

regulation

is

Royal

Decree

-LRB-

January

-RRB-

on

the

organization

of

health

services

provided

by

the

NHS

-LRB-

Fig.

-RRB-

It

provides

inclusion

and

exclusion

criteria

and

defines

the

current

level

of

provision

as

the

guaranteed

basic

health

care

basket

in

a

comprehensive

form

It

contains

a

checklist

of

services

that

constitute

the

entitlement

establishes

certain

exclusion

criteria

and

limits

the

provision

of

certain

services

due

to

the

limited

resources

available

to

the

NHS

It

also

stipulates

conditions

for

the

introduction

of

new

technologies

and

procedures

as

well

as

new

entitlements

Finally

it

prescribes

coordination

between

health

and

social

care.Fig

Royal

Decree

Services

activities

and

procedures

are

excluded

under

any

of

the

following

circumstances

-LRB-

a

-RRB-

There

is

insufficient

scientific

evidence

of

their

clinical

safety

and

efficacy

or

if

they

are

clearly

outdated

-LRB-

b

-RRB-

They

have

not

sufficiently

proven

their

effective

contribution

to

prevention

treatment

or

cure

illnesses

preservation

or

improvement

of

life

expectancy

self-help

or

elimination

or

reduction

of

pain

and

suffering

-LRB-

c

-RRB-

They

are

constitute

merely

activities

such

as

those

of

leisure

rest

comfort

sport

cosmetic

improvement

or

spa

The

Spanish

NHS

has

not

yet

in

fact

defined

a

basic

basket

of

services

although

Royal

Decree

established

a

general

framework

of

benefits

as

did

the

Law

of

May

-LRB-

Fig.

-RRB-

This

law

on

Cohesion

and

Quality

of

the

NHS

is

a

reform

that

built

on

the

previous

act

with

the

purpose

of

coordinating

a

strongly

decentralized

activity

Its

aim

is

to

establish

the

legal

framework

for

the

coordination

and

cooperation

of

the

Public

Health

Administrations

guaranteeing

equality

quality

and

participation

in

the

system

It

also

introduced

the

establishment

of

a

general

procedure

for

revisions

on

the

content

of

the

health

benefit

basket

Since

all

ACs

have

health

service

responsibilities

They

manage

their

regional

health

care

system

and

also

have

related

legislative

responsibilities

These

regional

health

care

baskets

must

include

at

least

the

benefits

defined

by

the

NHS

In

this

sense

Law

is

intended

to

sustain

the

coordination

and

the

basic

guarantees

between

all

the

territories.Fig

Law

Chapter

I

of

Law

refers

to

health

care

benefits

of

the

NHS

and

defines

a

catalogue

that

incorporates

the

benefits

defined

by

Royal

Decree

public

health

benefits

The

catalogue

of

benefits

is

defined

as

a

set

of

preventive

diagnostic

therapeutic

rehabilitative

services

and

direct

health

promotion

to

citizens

which

includes

public

health

primary

and

specialized

care

social

and

community

care

dietetic

urgencies

pharmacy

orthoprosthesis

products

and

sanitary

transport

benefits

It

guarantees

the

right

of

all

citizens

to

obtain

a

second

medical

opinion

the

right

to

receive

medical

assistance

in

one

's

own

AC

of

residence

within

a

maximum

time

along

and

the

right

to

receive

the

defined

benefits

of

the

NHS

under

the

same

conditions

and

guarantees

as

residents

in

other

ACs

As

a

further

development

of

the

Law

the

Spanish

Ministry

of

Health

is

currently

drafting

a

Royal

Decree

to

establish

the

NHS

health

benefit

basket

and

the

means

for

updating

it

The

purpose

of

the

Royal

Decree

is

to

guarantee

equality

and

appropriate

care

by

the

NHS

The

ACs

approve

their

own

baskets

by

always

including

all

the

services

of

the

NHS

health

benefit

basket

since

these

services

are

considered

a

basic

need

and

common

to

all

users

of

the

NHS

They

can

enlarge

their

own

baskets

with

additional

technical

services

technologies

and

procedures

New

benefits

added

to

the

basic

basket

are

evaluated

by

the

Ministry

of

Health

through

the

Evaluation

Agency

of

Health

Technologies

-LRB-

Agencia

de

Evaluación

de

Tecnologías

Médicas

-RRB-

and

the

Carlos

III

Health

Institute

in

collaboration

with

other

evaluation

agencies

proposed

by

the

ACs

and

the

Inter-Territorial

Council

of

the

NHS

Contents

of

the

benefit

baskets

for

curative

care

Inpatient

curative

care

The

above

regulation

affecting

inpatient

curative

care

defines

the

benefits

covered

by

the

NHS

which

ought

to

be

provided

by

all

ACs

-LRB-

free

of

any

user

payment

-RRB-

such

as

specialized

health

care

in

hospitals

which

includes

medical

attention

surgery

obstetric

and

pediatric

services

for

acute

conditions

worsening

of

chronic

conditions

or

delivery

of

recommended

diagnostic

treatments

or

procedures

organs

tissues

and

cells

of

human

origin

transplants

according

to

the

special

legislation

as

long

as

there

is

the

evidence

for

therapeutic

effectiveness

palliative

care

to

terminally

ill

patients

and

mental

health

care

and

psychiatric

assistance

which

includes

clinical

diagnosis

and

follow-up

and

the

prescribed

group

of

family

psychotherapy

if

it

implies

hospitalization

when

required

Hospitalizations

of

short

or

medium

periods

of

time

take

place

in

the

psychiatric

departments

of

general

hospitals

Inpatient

mental

long-term

care

services

take

place

at

psychiatric

hospitals

which

are

part

of

the

long-term

care

network

-LRB-

local

authorities

-RRB-

The

main

benefit

exclusions

are

mental

inpatient

care

-LRB-

included

only

upon

referral

-RRB-

and

transplants

of

hair

nails

and

placenta

Additional

benefits

on

the

part

of

ACs

include

sex/gender

change

surgery

intervention

such

as

that

now

offered

in

Andalusia

Andalusia

also

offers

epidural

anesthetics

during

birth

The

other

main

benefit

extension

is

related

to

euthanasia

Catalonia

Galicia

and

Extremadura

have

regulated

and

included

the

vital

testament

as

a

benefit

Day

cases

of

curative

care

The

entitlements

concerning

day

cases

of

curative

care

define

the

service

groups

included

in

the

Spanish

benefits

basket

as

specialized

ambulatory

health

care

consultations

that

could

include

minor

surgical

procedures

specialized

ambulatory

health

care

delivered

in

day

hospitals

for

patients

in

need

of

continuous

specialized

care

physician

's

or

nursing

services

including

major

surgery

as

long

as

no

hospitalization

is

required

and

hemotherapy

The

following

services

are

explicitly

excluded

plastic

surgery

when

it

is

not

related

to

accident

disease

or

congenital

malformation

sex

change

surgery

except

for

those

cases

in

which

it

is

necessary

to

repair

pathological

intersexual

conditions

Services

of

outpatient

care

Outpatient

care

is

generally

provided

in

primary

care

centers

or

specialist

care

centers

-LRB-

outpatient

clinics

-RRB-

There

is

a

wide

disparity

in

the

number

and

use

of

the

latter

among

ACs

These

categories

of

care

are

regulated

both

at

national

and

AC

levels

The

outpatient

benefit

basket

includes

the

following

service

groups

-LRB-

all

free

of

user

charges

-RRB-

health

assistance

for

health

consultation

services

and

centers

including

basic

medical

and

diagnostic

services

-LRB-

curative

-RRB-

primary

care

health

services

provided

at

home

indication

or

prescription

and

the

compliance

in

relevant

cases

with

examinations

and

basic

diagnostic

measures

as

indicated

by

the

primary

care

physician

the

administration

of

parenteral

treatments

cures

and

minor

surgery

initial

mental

assistance

is

provided

in

mental

health

centers

where

patients

are

being

evaluated

assisted

or

referred

to

other

assistance

services

Benefits

provided

include

pharmacological

and

psychotherapy

treatments

crisis

interventions

etc.

Mental

emergencies

can

also

be

treated

at

the

hospital

emergency

service

emergency

primary

health

care

which

will

be

provided

to

persons

of

any

age

and

delivered

continuously

h

a

day

through

medical

and

nursing

services

on

an

outpatient

basis

or

at

the

domicile

of

the

patient

if

the

situation

requires

to

do

so

primary

dental

health

care

including

dental

health

and

hygiene

information

and

education

preventive

and

assistance

measures

application

of

topical

fluoride

obstructions

sealing

of

fissures

or

other

services

for

the

infant

population

according

to

the

annual

financial

budget

and

special

programs

for

dental

health

treatment

of

acute

orthodontic

problems

including

dental

extractions

and

preventive

exploration

of

the

oral

cavity

in

pregnant

women

renal

lithotripsy

interventionist

radiology

and

radiotherapy

Certain

services

such

as

complex

diet

therapy

are

not

free

of

charge

but

are

also

not

explicitly

excluded

from

the

Spanish

health

care

benefit

basket

Other

services

such

as

spa

treatments

rest

cures

psychoanalysis

and

hypnosis

are

explicitly

excluded

In

this

category

of

care

many

ACs

offer

additional

services

as

part

of

their

benefit

catalogues

At

primary

care

level

the

Basque

Country

Extremadura

Castilla

La

Mancha

and

Catalonia

have

passed

several

decrees

at

specialized

outpatient

care

level

Navarre

offers

obstetrics

gynecological

and

family

planning

such

as

menopause

care

Valencia

provides

reactive

strips

for

determining

glucose

in

blood

and

urine

to

diabetics

and

at

special

treatment

level

the

Balearic

Islands

offer

neurological

reflexology

in

cooperation

with

the

Kovacs

Foundation

It

must

also

be

noted

that

Catalonia

has

started

a

pilot

experience

in

offering

acupuncture

for

arthritis

treatment

Nine

ACs

also

provide

free

dental

care

for

some

groups

Navarre

Basque

Country

Andalusia

Extremadura

Castilla

La

Mancha

Cantabria

Castilla

León

Murcia

and

Galicia

Catalonia

offers

periodic

rinsing

of

a

fluorine

solutions

program

for

primary

school

students

and

those

taking

the

first

two

courses

of

secondary

school

As

all

these

catalogues

are

quite

similar

we

present

below

the

dental

care

benefit

catalogue

of

Castilla

La

Mancha

-LRB-

Fig.

-RRB-

The

Infant-Young

Dental

Care

Plan

defines

the

group

of

measures

and

activities

both

preventive

and

welfare

as

well

as

any

procedures

to

provide

dental

care

Benefits

are

classified

into

oral

check-up

basic

dental

treatments

emergency

dental

treatments

special

dental

treatments

and

orthodontics.Fig

Dental

care

catalogues

the

example

of

Castilla

La

Mancha

Services

of

curative

home

care

As

part

of

the

entitlements

of

services

of

curative

home

care

oxygen

therapy

service

at

home

is

provided

at

authorized

and

specialized

centers

capable

of

carrying

out

gasometry

and

spirometry

The

Ministerial

Decree

of

March

-LSB-

-RSB-

elaborates

these

services

considering

the

following

benefits

-LRB-

a

-RRB-

oxygen

therapy

at

home

-LRB-

b

-RRB-

mechanical

ventilation

at

home

-LRB-

c

-RRB-

ventilation

treatment

of

the

sleep

apnea

symptoms

and

-LRB-

d

-RRB-

aerosol

therapy

Enteral

nutrition

is

also

provided

at

home

This

service

is

made

available

to

patients

who

suffer

from

the

following

symptoms

swallowing

transit

digestion

or

absorption

of

foods

in

its

natural

form

problems

or

when

special

requirements

of

energy

and/or

nutrients

exist

that

can

not

be

covered

with

foods

of

daily

consumption

Royal

Decree

has

been

developed

with

regard

to

benefits

with

diet

products

in

two

ways

regulating

complex

diet

therapy

and

regulating

enteral

nutrition

at

home

Complex

diet

therapy

is

dealt

with

in

the

Ministerial

Decree

of

April

-LSB-

-RSB-

which

specifies

the

relationship

of

congenital

metabolic

upheavals

of

carbon

hydrates

and

amino

acids

included

in

this

benefit

and

the

type

of

diet

in

each

case

It

also

prescribes

these

treatments

to

be

performed

by

a

special

physician

in

hospital

units

specifically

authorized

by

the

appropriate

Health

Administration

Enteral

nutrition

at

home

is

regulated

by

the

Ministerial

Decree

of

June

-LSB-

-RSB-

which

defines

the

requirements

and

the

patient

's

clinical

situation

for

this

There

are

also

regulations

at

the

national

and

interterritorial

council

levels

as

well

as

in

six

ACs

that

have

developed

their

own

dietetic

regulations

The

Ministerial

Decree

of

March

was

passed

upon

the

proposal

of

a

panel

of

experts

-LRB-

Fig.

-RRB-

This

elaborates

Royal

Decree

regarding

the

techniques

of

oxygen

therapy

at

home

financed

by

the

NHS

and

clarifies

and

standardizes

the

criteria

clinical

situations

and

other

matters

for

the

direction

prescription

and

provision

of

these

benefits

It

defines

the

oxygen

therapy

techniques

that

can

be

carried

out

at

home

in

terms

of

their

financing

by

the

NHS

and

establishes

the

basic

requirements

that

justify

their

prescription

The

Ministerial

Decree

of

March

thus

provides

a

common

basis

upon

which

the

health

service

providers

must

develop

their

own

procedure

for

providing

and

supervising

these

benefits

The

Decree

actually

does

not

provide

a

benefit

catalogue

as

such

because

the

individual

physician

determines

the

specific

treatment

in

each

case

In

addition

there

are

also

specific

regional

oxygen

therapy

regulations

in

four

ACs

-LRB-

Andalusia

Canary

Islands

Navarre

and

Valencia

-RRB-

Fig.

Oxygen

therapy

at

home

Services

of

MUFACE

catalogue

All

civil

servants

and

beneficiaries

are

entitled

to

receive

benefits

as

determined

by

the

MUFACE

catalogue

This

benefit

basket

is

virtually

equivalent

to

that

of

the

NHS

but

include

some

additional

benefits

The

principal

difference

is

related

to

copayments

for

pharmaceuticals

In

addition

to

particular

features

for

medical

assistance

abroad

orthoprosthetic

dental

care

ocular

pharmaceutical

and

sociosanitary

benefits

services

such

as

vaccinations

are

included

free

of

charge

Specialized

health

care

includes

all

the

medical

and

surgical

specialties

both

in

outpatient

and

inpatient

sectors

The

specialties

are

structured

in

four

levels

according

to

their

complexity

and

geographic

scope

sanitary

transport

oxygen

therapy

and

aerosol

therapy

at

home

Discussion

The

way

in

which

the

Spanish

benefit

catalogue

is

defined

is

characteristic

of

tax-financed

NHS

health

care

systems

A

system

such

as

that

in

Spain

which

guarantees

universal

coverage

is

not

completely

developed

until

it

is

specifies

a

minimum

basket

of

health

care

services

However

as

no

specific

and

explicit

benefit

catalogue

is

being

developed

there

remains

a

need

for

further

legislation

The

Ministry

of

Health

and

Consumption

is

moving

towards

an

explicit

process

of

decision

making

in

health

benefit

planning

instead

of

defining

a

detailed

benefit

catalogue

As

is

the

case

in

many

countries

the

possibility

of

using

regional

plans

as

the

basis

for

resource

allocation

and

capacity

planning

has

not

yet

been

considered

An

additional

problem

in

Spain

is

the

fact

that

the

majority

of

health

care

plans

offer

unrealistically

long

lists

of

objectives

which

are

often

not

sufficiently

based

on

available

epidemiological

and

cost-effectiveness

evidence

and

their

efficacy

is

seldom

evaluated

They

can

not

be

considered

as

benefit

catalogues

since

they

are

not

sufficiently

strong

legal

instruments

and

therefore

users

are

not

able

to

claim

the

objectives

contained

in

the

health

plans

as

benefit

rights

Then

purpose

of

the

Spanish

health

benefits

basket

is

twofold

as

it

was

initially

established

to

serve

more

as

a

budgetary

than

as

a

cost

containment

measure

when

created

by

the

Social

Security

act

-LSB-

-RSB-

However

on

the

other

hand

as

Royal

Decree

and

the

Cohesion

Law

recognize

they

are

merely

an

ordering

of

benefits

as

they

try

only

to

describe

what

is

being

offered

in

practice

Two

major

aspects

of

the

Spanish

health

care

system

are

-LRB-

a

-RRB-

A

more

explicit

definition

of

the

benefit

basket

is

needed

as

the

present

vague

definition

leaves

the

final

decisions

to

practitioners

making

expenditure

very

volatile

and

having

as

the

sole

restriction

that

of

waiting

times

-LRB-

b

-RRB-

Greater

transparency

is

needed

in

the

process

of

approval/rejection

of

new

benefits

towards

agents

in

the

health

sector

and

towards

citizenship

along

with

the

need

to

include

economic

considerations

in

the

decision

process

In

Spain

it

still

remains

the

case

all

for

everyone

and

almost

everything

for

free

This

obviously

leads

to

long

waiting

times

and

thus

a

dual

system

-LRB-

public-private

-RRB-

for

those

able

to

skip

the

long

queues

and

high

public

pressure

over

resources

devoted

to

the

NHS

Furthermore

since

there

are

no

user

payments

waiting

lists

serve

as

the

mechanisms

restricting

demand

for

health

services

For

the

first

time

the

Catalan

Health

Service

is

now

studying

the

possibility

of

introducing

a

copayment

system

in

primary

care

-LRB-

fixed

payment

per

visit

-RRB-

There

are

still

some

remaining

problems

in

the

Spanish

benefit

basket

In

terms

of

equality

the

fact

that

MUFACE-type

schemes

have

not

been

fully

integrated

to

the

NHS

provides

additional

benefits

for

these

groups

There

is

a

lack

of

real

control

over

the

managers

of

the

health

care

services

Autonomy

of

decisions

by

practitioners

may

mean

an

obstacle

to

the

early

evaluation

of

new

technologies

since

under

uso

tutelado

-LRB-

monitored

use

-RRB-

it

is

physicians

who

start

using

them

In

the

present

financing

system

there

is

no

relationship

between

this

and

the

benefits

provided

nor

a

control

mechanism

over

what

is

provided

in

reality

Moreover

the

information

systems

are

clearly

the

main

problem

in

the

decentralization

process

To

overcome

this

problem

the

Ministry

of

Health

has

recently

introduced

an

institution

for

monitoring

the

health

system

Even

the

appearance

of

new

benefit

differences

across

ACs

will

not

affect

equality

such

as

it

may

affect

clinical

practices

and

access

to

equipment

Therefore

the

main

purposes

of

the

Spanish

health

policy

are

to

promote

common

clinical

guidelines

and

evaluation

processes

with

a

single

registry

on

new

infrastructure

and

the

creation

and

regulation

of

a

common

procedure

for

new

benefit

approvals

In

the

future

the

central

government

is

not

expected

to

increase

benefits

but

rather

the

quality

of

the

existing

ones

through

new

technologies

and

clinical

procedures

Improvements

are

expected

regarding

the

provision

of

services

-LRB-

e.g.

waiting

times

-RRB-

better

user

information

and

increased

range

of

choices

Probably

the

most

important

task

is

the

development

of

a

long-term

care

or

dependency

system

and

a

real

network

of

mental

health

Future

reforms

taken

by

the

different

ACs

will

likely

address

the

benefits

basket

Dental

care

and

natural

and

alternative

medicines

are

probably

the

first

services

that

will

be

addressed

The

definition

of

a

basic

long-term

social

and

community

care

benefit

basket

similar

to

that

in

health

care

will

also

be

a

priority

for

the

central

government

Nevertheless

as

we

can

see

in

Table

new

benefits

have

very

little

impact

on

the

health

expenditure

of

ACs.Table

Spending

in

the

provision

of

health

care

services

not

included

in

the

benefit

catalogue

of

the

National

Health

System

-LRB-

Royal

Decree

-RRB-

proportion

of

total

health

care

services

Aragon

Asturias

Balearic

Islands

Canary

Island

Cantabria

Castilla

y

León

Castilla

La

Mancha

Valencia

Extremadura

Galicia

Madrid

Murcia

Basque

La

Rioja

Ceuta

Melilla

Finally

in

Spain

the

growth

of

public

health

expenditure

is

due

to

both

the

increase

in

input

prices

and

the

received

average

benefits

per

capita

The

growth

of

public

health

care

expenditure

is

largely

attributable

to

the

benefits

provided

The

yearly

change

in

health

care

benefits

was

responsible

for

of

the

annual

average

increase

in

health

expenditure

between

and

O O O 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 O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O 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 O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O 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 O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O 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 O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O 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 O O O O O O O O O O O O O O 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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Left ventricular dyssynchrony assessed by two three-dimensional imaging modalities : phase analysis of gated myocardial perfusion SPECT and tri-plane tissue Doppler imaging Purpose To compare left ventricular -LRB- LV -RRB- dyssynchrony assessment by phase analysis from gated myocardial perfusion SPECT -LRB- GMPS -RRB- with LV dyssynchrony assessment by tri-plane tissue Doppler imaging -LRB- TDI -RRB- . Baseline LV dyssynchrony assessed with standard deviation -LRB- SD -RRB- of time-to-peak systolic velocity of 12 LV segments -LRB- Ts-SD -RRB- with TDI has proven to be a powerful predictor of response to CRT . Information on LV dyssynchrony can also be provided by GMPS with phase analysis of regional LV maximal count changes throughout the cardiac cycle . Introduction Cardiac resynchronization therapy -LRB- CRT -RRB- has become an established therapy for patients with end-stage heart failure -LSB- 1 -RSB- . However , up to 30 % of the patients do not respond to CRT when selection is based on the traditional clinical and electrocardiographic criteria -LSB- New York Heart Association -LRB- NYHA -RRB- functional class III or IV , left ventricular ejection fraction -LRB- LVEF -RRB- < 35 % , and QRS duration > 120 ms -RSB- -LSB- 2 -RSB- . In the search for better selection criteria for CRT , it has been shown that patients with LV dyssynchrony have a higher likelihood of a positive response to CRT -LSB- 3 -- 8 -RSB- . Over the past few years , the assessment of LV dyssynchrony has been studied extensively with echocardiography . The most frequently used technique is tissue Doppler imaging -LRB- TDI -RRB- , which permits evaluation of timing of regional myocardial velocity and comparison of different regions yields information on LV dyssynchrony . Bax et al. -LSB- 3 -RSB- have used a four-segment model to assess LV dyssynchrony -LRB- four basal LV segments : anterior , lateral , inferior and septal -RRB- and reported that a delay ≥ 65 ms among the four segments was a strong predictor of response to CRT . Other authors extended the analysis by evaluating the activation pattern of the entire LV . This method , originally described by Yu and co-workers -LSB- 6 -- 8 -RSB- , uses the standard deviation -LRB- SD -RRB- of electromechanical activation times based on a 12-segment model of LV -LRB- Ts-SD -RRB- . The authors investigated 56 patients with heart failure who underwent CRT implantation and demonstrated that a cut-off value of 34.4 ms for Ts-SD could predict reverse LV remodeling after CRT with a sensitivity of 87 % and a specificity of 81 % -LSB- 7 -RSB- . However , to calculate this parameter of LV dyssynchrony , three apical views need to be acquired separately . A 3-dimensional -LRB- 3D -RRB- TDI imaging modality -LRB- tri-plane TDI -RRB- has become available to overcome this limitation . Tri-plane TDI allows simultaneous acquisition of all LV segments during the same heartbeat rendering the technique more precise than the 2-dimensional -LRB- 2D -RRB- TDI equivalent . Another recent development is the use of gated myocardial perfusion single photon emission computed tomography -LRB- GMPS -RRB- for assessment of LV dyssynchrony -LSB- 9 , 10 -RSB- . A count-based method has been developed to extract phase information from the regional LV count changes throughout the cardiac cycle , and this phase information is related to the time interval when a region , in the 3D LV wall starts to contract -LRB- phase analysis -RRB- . This technique has recently been implemented in the Emory Cardiac Toolbox as a diagnostic tool for assessment of LV mechanical dyssynchrony -LSB- 9 -RSB- . To further validate the use of GMPS with phase analysis for the assessment of LV dyssynchrony , a direct comparison with tri-plane TDI was performed in a cohort of heart failure patients . Materials and methods Patients and study protocol Forty consecutive patients with heart failure , referred for evaluation of potential eligibility for CRT , were included in this study . Traditional selection criteria for CRT were applied , including moderate-to-severe drug refractory heart failure -LRB- NYHA class III or IV -RRB- , depressed LVEF -LRB- < 35 % -RRB- and prolonged QRS duration -LRB- > 120 ms -RRB- . Patients with a recent myocardial infarction -LRB- < 3 months -RRB- or decompensated heart failure were excluded . Evaluation of the clinical status included assessment of NYHA functional class , quality-of-life score -LRB- using the Minnesota quality-of-life questionnaire -RRB- and exercise capacity -LRB- using the 6-min walk test -RRB- . Extensive echocardiographic analysis , using 3D transthoracic echocardiography , was performed to assess LV dyssynchrony . Resting GMPS with technetium-99m tetrofosmin was clinically performed to exclude extensive ischemia and/or viability -LSB- 11 , 12 -RSB- , in order to refer patients to revascularization if indicated . Thereafter , all scans were subjected to phase analysis to evaluate LV dyssynchrony . The results of the phase analysis with GMPS to assess LV dyssynchrony were subsequently compared with LV dyssynchrony derived from tri-plane TDI . Echocardiography 3D data set acquisition All patients underwent transthoracic echocardiography performed with a commercially available echocardiographic platform -LRB- VIVID 7 , GE Vingmed Ultrasound , Horten , Norway -RRB- and equipped with a 3V-probe for 3D acquisition . Patients were scanned in left lateral decubitus position , from the apical window in tri-plane modus , acquiring simultaneously the apical four - , two - and three-chamber views . Care was taken to visualize the true LV apex . Color-coded TDI was applied to the tri-plane view to assess longitudinal myocardial regional function . Gain settings , filters and pulse repetition frequency were adjusted to optimize color saturation . Sector size and depth were optimized for the highest possible frame rate . At least two consecutive beats were recorded from each view , and the images were digitally stored for off-line analysis -LRB- EchoPac , GE Vingmed Ultrasound , Horten , Norway -RRB- . The echocardiographic examination and the off-line analysis were performed by the same experienced echocardiographist , blinded to the GMPS and clinical data . 3D analysis of LV dyssynchrony During post-processing , the tri-plane TDI dataset was used to analyze myocardial velocity curves as previously described with 2D TDI echocardiography -LSB- 6 -- 8 -RSB- . Sample volumes were placed in the basal and mid segments of the septal , lateral , inferior , anterior , posterior and anteroseptal LV walls to calculate the time from the beginning of the QRS complex to peak systolic velocity -LRB- Ts -RRB- , using the same heart beat -LRB- Fig. 1 -RRB- . Subsequently , the standard deviation of Ts -LRB- Ts-SD -RRB- of the 12 myocardial segments was calculated and used as a parameter of LV dyssynchrony -LSB- 6 -- 8 -RSB- . A cut-off value of Ts-SD ≥ 33 ms was used to define the presence of substantial LV dyssynchrony . Fig. 1Example of the myocardial velocity curves that can be derived by positioning the sample volume in any LV segment of the tri-plane dataset . This patient has substantial LV dyssynchrony : the postero-lateral and anterior walls -LRB- orange , light blue and red curves -RRB- are activated later than the septal and inferior walls -LRB- yellow and green curves -RRB- ; standard deviation of 12 LV segments ' Ts is 57.5 ms Gated myocardial perfusion SPECT Resting GMPS with technetium-99m tetrofosmin -LRB- 500 MBq , injected at rest -RRB- was performed using a triple head SPECT camera system -LRB- GCA 9300/HG , Toshiba Corp. -RRB- equipped with low energy high-resolution collimators . Around the 140-KeV energy peak of technetium-99m tetrofosmin , a 20 % window was used . A total of 90 projections -LRB- step and shoot mode , 35 s per projection , imaging time 23 min -RRB- were obtained over a 360-degrees circular orbit . GMPS acquisition involved 16 frames per cardiac cycle . Data were reconstructed by filtered backprojection and then re-oriented to yield gated short-axis images . Data reconstruction was performed over 360 degrees . These images were then submitted to the Emory Cardiac Toolbox for phase analysis -LSB- 9 -RSB- . GMPS images were analyzed at the department of radiology of Emory University School of Medicine by J.C. and E.V.G. , who were blinded to the echocardiographic and clinical data . A phase distribution was extracted from a GMPS study , representing the regional onset of mechanical contraction of the LV . It can be displayed in a polar map or in 3D and used to generate a phase histogram . An example of a patient without LV dyssynchrony is shown in Fig. 2a , whereas an example of a patient with substantial LV dyssynchrony as assessed with phase analysis by GMPS is shown in Fig. 2b . The following four quantitative indices were obtained from the phase analysis of all patients : -LRB- 1 -RRB- histogram bandwidth , which includes 95 % of the elements of the phase distribution ; -LRB- 2 -RRB- phase SD , which is the SD of the phase distribution ; -LRB- 3 -RRB- phase histogram skewness , which indicates the symmetry of the histogram ; -LRB- 4 -RRB- histogram kurtosis , which indicates the degree to which the histogram is peaked -LSB- 9 -RSB- . In a healthy individual the LV contracts in a coordinated manner , and the phase distribution is nearly uniform with a highly peaked distribution of the histograms . As the LV contraction becomes dyssynchronous , the phase SD and histogram bandwidth are expected to increase -LRB- Fig. 2b -RRB- . Fig. 2a Example of a patient without LV dyssynchrony on GMPS . The non-normalized -LRB- upper panel -RRB- and normalized -LRB- lower panel -RRB- phase distributions are nearly uniform and the corresponding phase histograms are highly-peaked , narrow distributions . b Example of a patient -LRB- same as in Fig. 1 -RRB- with LV dyssynchrony on GMPS . The non-normalized -LRB- upper panel -RRB- and normalized -LRB- lower panel -RRB- phase distributions show significant non-uniformity and the corresponding phase histograms have widespread distributions Statistical analysis Continuous data are presented as mean ± SD ; dichotomous data are presented as numbers and percentages . Comparison of data was performed using the unpaired Student 's t test or χ2 test when appropriate . Pearson 's correlation analysis was performed to evaluate the relation between histogram bandwidth , phase SD , histogram skewness and histogram kurtosis by the phase analysis of GMPS and LV dyssynchrony -LRB- Ts-SD -RRB- by tri-plane TDI . A p-value < 0.05 was considered to be statistically significant . A statistical software program SPSS 12.0 -LRB- SPSS Inc , Chicago , Il -RRB- was used for statistical analysis . Results Study population A total of 40 consecutive patients with heart failure were included in this study -LSB- 29 -LRB- 72 % -RRB- men ; mean age 66 ± 10 years -RSB- . Baseline characteristics are summarized in Table 1 . Patients had severe LV dysfunction -LRB- mean LVEF 26 ± 7 % -RRB- , with extensive LV dilatation -LRB- mean LV end-diastolic volume 210 ± 48 ml -RRB- . LV dyssynchrony assessment with tri-plane TDI demonstrated a mean value of Ts-SD of 34 ± 15 ms. Table 1Baseline characteristics of the study population -LRB- n = 40 -RRB- Age -LRB- years -RRB- 66 ± 10Gender -LRB- M/F -RRB- 29/11NYHA class 3.0 ± 0.46-MWT -LRB- m -RRB- 282 ± 126QoL score38 ± 17QRS duration -LRB- ms -RRB- 147 ± 33Etiology , n -LRB- % -RRB- Ischemic25 -LRB- 62 -RRB- Idiopathic 15 -LRB- 38 -RRB- LVEF -LRB- % -RRB- 26 ± 7LVEDV -LRB- ml -RRB- 210 ± 48LVESV -LRB- ml -RRB- 157 ± 43Medication , n -LRB- % -RRB- ACE Inhibitors34 -LRB- 85 -RRB- β-blockers28 -LRB- 70 -RRB- Diuretics and/or spironolactone36 -LRB- 90 -RRB- LVEDV = left ventricular end-diastolic volume ; LVEF = left ventricular ejection fraction ; LVESV = left ventricular end-systolic volume ; 6-MWT = 6-min walk test ; QoL = quality of life score ; Ts-SD = standard deviation of time to peak systolic velocity of 12 LV segments Histogram bandwidth The mean histogram bandwidth was 130 ° ± 69 ° -LRB- range 41 ° to 260 ° -RRB- ; the normal value is 38.7 ° ± 11.8 ° for men and 30.6 ° ± 9.6 ° for women -LSB- 9 -RSB- . A good correlation between histogram bandwidth and LV dyssynchrony , assessed with tri-plane TDI , was observed -LRB- r = 0.77 , p < 0.0001 , Fig. 3 -RRB- . Fig. 3Correlation between histogram bandwidth assessed with GMPS and LV dyssynchrony assessed with tri-plane TDI -LRB- Ts-SD -RRB- Phase SD The mean phase SD was 40.2 ° ± 18.8 ° -LRB- range 14.5 ° to 77.9 ° -RRB- , whereas the normal value is 14.2 ° ± 5.1 ° for men and 11.8 ° ± 5.2 ° for women -LSB- 9 -RSB- . Pearson 's correlation showed a good correlation between phase SD and Ts-SD -LRB- r = 0.74 , p < 0.0001 , Fig. 4 -RRB- . Fig. 4Phase SD assessed with GMPS versus LV dyssynchrony assessed with tri-plane TDI -LRB- Ts-SD -RRB- Histogram skewness The mean histogram skewness was 2.50 ± 0.81 -LRB- range 1.16 to 5.49 -RRB- , whereas the normal value is 4.19 ± 0.68 for men and 4.60 ± 0.72 for women -LSB- 9 -RSB- . A poor correlation with LV dyssynchrony assessed with tri-plane TDI was demonstrated by Pearson 's correlation -LRB- r = -0.30 , p = 0.06 -RRB- . Histogram kurtosis The mean histogram kurtosis was 7.38 ± 6.23 -LRB- range 1.08 to 37.42 -RRB- , whereas the normal value is 19.72 ± 7.68 for men and 23.21 ± 8.16 for women -LSB- 9 -RSB- . No correlation between histogram kurtosis and Ts-SD was shown by Pearson 's correlation -LRB- r = − 0.14 , p = 0.38 -RRB- . Substantial versus no substantial LV dyssynchrony Of the 40 patients included , 20 -LRB- 50 % -RRB- had a substantial LV dyssynchrony -LRB- defined as Ts-SD ≥ 33 ms -RRB- -LSB- 7 , 8 -RSB- . No significant differences in baseline characteristics were noted between the two patient groups -LRB- Table 2 -RRB- . Histogram bandwidth and phase SD were significantly higher in patients with Ts-SD ≥ 33 ms compared to patients with Ts-SD < 33 ms : 186 ° ± 52 ° versus 74 ° ± 24 ° -LRB- p < 0.0001 -RRB- and 55.3 ° ± 13.6 ° versus 25.1 ° ± 7.6 ° -LRB- p < 0.0001 -RRB- , respectively -LRB- Fig. 5a and b -RRB- . In addition , histogram skewness was significantly lower in patients with Ts-SD ≥ 33 ms than in patients with Ts-SD < 33 ms -LRB- 2.23 ± 0.93 versus 2.78 ± 0.55 , p = 0.03 -RRB- . No significant difference between the two groups was observed for histogram kurtosis -LRB- 6.36 ± 7.94 versus 8.4 ± 3.79 , p = NS -RRB- -LRB- Fig. 5c and d -RRB- . An example of a patient with substantial LV dyssynchrony on both tri-plane TDI as well as on phase analysis with GMPS is provided in Figs. 1 and 2b . Table 2Baseline characteristics of patients with substantial -LRB- ≥ 33 ms -RRB- and no substantial LV dyssynchrony -LRB- < 33 ms -RRB- assessed by SD of time-to-peak systolic velocity of 12 LV segments -LRB- Ts-SD -RRB- Ts-SD ≥ 33 ms -LRB- n = 20 -RRB- Ts-SD < 33 ms -LRB- n = 20 -RRB- p-valueAge -LRB- years -RRB- 67 ± 1066 ± 9NSGender -LRB- M/F -RRB- 14/615/5NSQRS duration -LRB- ms -RRB- 145 ± 31149 ± 36NSNYHA class 3.0 ± 0.43.0 ± 0.4 NSEtiology , n -LRB- % -RRB- Ischemic 14 -LRB- 70 -RRB- 11 -LRB- 55 -RRB- NS Idiopathic6 -LRB- 30 -RRB- 9 -LRB- 45 -RRB- NSLVEF -LRB- % -RRB- 25 ± 726 ± 7NSLVEDV -LRB- ml -RRB- 209 ± 47207 ± 50NSLVESV -LRB- ml -RRB- 159 ± 46153 ± 42NSHistogram bandwidth -LRB- ° -RRB- 186 ± 5274 ± 24 < 0.0001 Phase SD -LRB- ° -RRB- 55.3 ± 13.625.1 ± 7.6 < 0.0001 Histogram skewness2 .23 ± 0.932.78 ± 0.550.03 Histogram kurtosis6 .36 ± 7.948.40 ± 3.79 NSFor abbreviations see Table 1 . Fig. 5a Patients with substantial versus no substantial LV dyssynchrony -LRB- Ts-SD -RRB- , using a cut-off value ≥ 33 ms. Histogram bandwidth is significantly higher in patients with substantial LV dyssynchrony . b Patients with substantial versus no substantial LV dyssynchrony -LRB- Ts-SD -RRB- , using a cut-off value ≥ 33 ms. Phase SD is significantly higher in patients with substantial LV dyssynchrony . c Patients with substantial versus no substantial LV dyssynchrony -LRB- Ts-SD -RRB- , using a cut-off value ≥ 33 ms. Histogram skewness is significantly lower in patients with substantial LV dyssynchrony . d Patients with substantial versus no substantial LV dyssynchrony -LRB- Ts-SD -RRB- , using a cut-off value ≥ 33 ms. No significant difference in histogram kurtosis was demonstrated between patients without and patients with substantial LV dyssynchrony as assessed with tri-plane echocardiography Ischemic versus idiopathic dilated cardiomyopathy In total , 25 patients -LRB- 62 % -RRB- had an ischemic cardiomyopathy and 15 patients -LRB- 38 % -RRB- had an idiopathic dilated cardiomyopathy . No differences in echocardiographic variables , including LV dyssynchrony assessed by tri-plane TDI , or GMPS phase analysis indices were found between ischemic and non-ischemic patients . No significant differences in correlation coefficients were observed between patients with ischemic cardiomyopathy and patients with idiopathic dilated cardiomyopathy for the four different GMPS variables -LRB- Table 3 -RRB- . Table 3Correlation coefficients of LV dyssynchrony , assessed with tri-plane TDI , versus the different LV dyssynchrony parameters , derived from phase analysis of GMPS -LRB- idiopathic dilated cardiomyopathy versus ischemic cardiomyopathy -RRB- Ischemic cardiomyopathy -LRB- n = 25 -RRB- Idiopathic dilated cardiomyopathy -LRB- n = 15 -RRB- p-valueHistogram bandwidthr = 0.79 r = 0.78 NSPhase SDr = 0.77 r = 0.75 NSHistogram skewnessr = − 0.22 r = − 0.48 NSHistogram kurtosisr = − 0.07 r = − 0.35 NS Discussion The main findings of the present study can be summarized as follows : -LRB- 1 -RRB- LV dyssynchrony assessment with phase analysis on GMPS is feasible in heart failure patients screened for eligibility for CRT implantation . The phase analysis variables histogram bandwidth and phase SD show good correlation with LV dyssynchrony as measured with tri-plane TDI -LRB- Ts-SD -RRB- , suggesting that GMPS phase analysis can be used to quantify LV dyssynchrony . -LRB- 2 -RRB- Patients with substantial LV dyssynchrony on tri-plane TDI have significantly higher values of histogram bandwidth and phase SD derived from phase analysis with GMPS -LRB- histogram bandwidth : 186 ° ± 52 ° versus 74 ° ± 24 ° , p < 0.0001 -RRB- and phase SD : 55.3 ° ± 13.6 ° versus 25.1 ° ± 7.6 ° -LRB- p < 0.0001 -RRB- . CRT is now considered an important therapeutic option in the treatment of patients with end-stage heart failure -LSB- 1 -RSB- . Although encouraging beneficial effects have been reported , including improvement in LVEF and reduction in heart failure symptoms , it has also been demonstrated that up to 30 % of patients do not have a favorable response to CRT . The presence of LV dyssynchrony is considered a key issue in the identification of potential responders to CRT -LSB- 3 -- 6 -RSB- . Echocardiography and in particular TDI have been extensively used to assess LV dyssynchrony . Several parameters derived from myocardial velocity curves of different LV segments have been proposed to quantify LV dyssynchrony and predict response to CRT -LSB- 3 -- 8 -RSB- . Yu and coworkers described a model -LRB- derived from 2D TDI data -RRB- to quantify global LV dyssynchrony using Ts-SD of 12 LV segments -LSB- 6 -- 8 -RSB- . The authors reported a cut-off value > 32.6 ms to distinguish between responders and non-responders -LSB- 8 -RSB- and a cut-off value > 34.4 ms as the most powerful predictor of LV reverse remodeling -LSB- 7 -RSB- . In this study LV dyssynchrony was evaluated by Ts-SD from tri-plane TDI and compared with LV dyssynchrony assessment with phase analysis by GMPS . The tri-plane TDI technique avoids the problem of heart rate variability since simultaneous acquisition of the three apical views is possible ; in the present study a cut-off value ≥ 33 ms was used to define substantial LV dyssynchrony on tri-plane TDI . Information on cardiac dyssynchrony can also be derived from nuclear imaging . Kerwin et al. -LSB- 13 -RSB- evaluated interventricular dyssynchrony in 13 heart failure patients using multi-gated equilibrium blood pool scintigraphy and phase analysis . Patients were imaged during biventricular pacing and in sinus rhythm . During biventricular pacing , a significant improvement in interventricular synchrony was observed . Moreover , an improvement in LVEF was reported for all 13 patients during biventricular pacing -LRB- 17.2 ± 7.9 % to 22.5 ± 8.3 % , p < 0.0001 -RRB- , and the increase in LVEF correlated significantly with the improvement in interventricular synchrony -LRB- r = 0.86 ; p < 0.001 -RRB- . Fauchier et al. -LSB- 14 -RSB- used equilibrium radionuclide angiography and phase analysis to evaluate the prognostic value of interventricular and intraventricular dyssynchrony in 103 patients with idiopathic dilated cardiomyopathy . Phase images were generated from the scintigraphic data , and mean phase angles and SDs were calculated for the right and left ventricle . During a follow-up period of 27 ± 23 months , 18 major cardiac events occurred . Multivariate analysis revealed that LV intraventricular dyssynchrony and elevated pulmonary capillary wedge pressure were the only independent predictors of cardiac events . GMPS is currently used in patients with heart failure to exclude ischemia and/or viability before referring for CRT implantation and to assess total scar burden in patients with ischemic cardiomyopathy -LSB- 11 , 12 -RSB- . Indeed , various studies have shown that the presence of severe resting perfusion defects , as assessed with GMPS , limits the response to CRT -LSB- 15 -- 17 -RSB- . Recently , Chen et al. -LSB- 9 -RSB- developed with GMPS a count-based method to extract phase information from the regional LV count changes throughout the cardiac cycle . The phase information is related to the regional onset of mechanical contraction of the LV -LRB- phase analysis -RRB- and provides information on the synchronicity of the LV contraction . The authors assessed in 90 normal individuals the normal range for four quantitative indices that can be used as markers of LV dyssynchrony -LRB- histogram bandwidth , phase SD , histogram skewness and histogram kurtosis -RRB- -LSB- 9 -RSB- . Recently , these four GMPS indices have been compared with LV dyssynchrony assessment by TDI in 75 patients with severe heart failure . It was shown that among the four quantitative indices of phase analysis , the variables histogram bandwidth and phase SD correlated best with LV dyssynchrony as assessed by TDI -LSB- 10 -RSB- . The current study involved a different patient subset and provides further support that phase analysis with GMPS can be useful in the evaluation of LV dyssynchrony . The value of GMPS to assess LV dyssynchrony has been analyzed , and the indices derived from phase analysis were compared with Ts-SD measured by tri-plane TDI . It was shown that histogram bandwidth and phase SD correlated well with Ts-SD as evaluated by tri-plane TDI -LRB- histogram bandwidth : r = 0.77 and phase SD : r = 0.74 -RRB- . In addition , significantly higher values for histogram bandwidth and phase SD were observed in patients with substantial LV dyssynchrony on tri-plane TDI compared with patients without substantial LV dyssynchrony on tri-plane TDI . Limitations In the present study , follow-up data after CRT implantation were not available . Therefore , the value of phase analysis to predict response to CRT could not be determined . Furthermore , GMPS may be less suitable for repeated analysis during the follow-up after CRT implantation , due to the radiation burden of the technique . Conclusions The results of this study confirm the feasibility to evaluate LV dyssynchrony with phase analysis by GMPS and its applicability in the clinical setting . In particular , histogram bandwidth and phase SD showed a good correlation with LV dyssynchrony measured with Ts-SD as assessed with tri-plane TDI . Future prospective studies in larger patient populations with follow-up after CRT implantation are needed to elucidate the potential role of GMPS with phase analysis for prediction of response to CRT .

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

lv dyssynchrony
tdi
heart failure
nuclear imaging


A rare case of complete C2 -- C3 dislocation with mild neurological symptoms The authors report a rare case of complete C2 -- C3 dislocation with unexpectedly mild neurological symptoms in a 57 year old man involved in a motor vehicle accident , who had previously undergone posterior laminectomy from C3 through C7 . A retrospective chart analysis and a thorough radiographic review were performed . X-rays and CT of the cervical spine demonstrated a complete dislocation at the C2 -- C3 level . Computed tomographic angiography revealed disruption of both vertebral arteries ; however , blood flow was evident in the basilar artery . After radiologically guided placement in cervical traction with tongs that reduced the subluxation by approximately 50 % the patient had spontaneous eye opening and was able to follow commands . A two-stage 360o stabilization and fusion was performed and the patient was finally discharged 24 days after admission with his neurological status essentially unchanged . In conclusion , our patient presented with surprisingly mild neurological symptoms . The previously performed laminectomy could have both predisposed to injury as well as protected his spinal cord from potentially fatal trauma . Introduction Subluxation of the cervical spine in adults usually occurs at its lower segments -LRB- C4 -- C7 -RRB- -LSB- 12 , 14 -RSB- ; 50 % of anterior subluxation of the neck has been reported to involve the highly mobile C5 -- C6 junction -LSB- 11 , 14 -RSB- . In the pediatric population -LRB- up to 9 years old -RRB- , the upper cervical spine is more susceptible to injury due to the anatomical differences in the developing spine -LSB- 3 -RSB- . Subluxation at the C2 -- C3 level is a particularly uncommon injury . We report a case of complete dislocation at the C2 -- C3 level in a patient involved in a motor vehicle accident who presented with surprisingly mild neurological symptoms . Case report A 57 year old African American man under the influence of alcohol and benzodiazepines was involved in a severe motor vehicle accident including one fatality . The patient was wearing a seat belt . He was transferred to our clinic via ambulance from a community hospital , fully immobilized with a hard cervical collar on , while the spinal cord injury solumedrol protocol had been initiated . On arrival to our Emergency Department , the patient had a Glascow Coma Scale -LRB- GCS -RRB- score of 11 and was thrashing all extremities . He responded to pain . He was intubated and thorough radiologic evaluation was undertaken . The CT of the brain revealed a slender tentorial subdural hematoma not requiring surgical evacuation . X-rays and CT of the cervical spine revealed a complete dislocation at the C2 -- C3 level with acute angulation between the two cervical vertebral segments -LRB- Fig. 1 -RRB- . Additionally , the imaging studies demonstrated multi-level degenerative spondylosis , anterior bridging osteophytes from C3 through C7 consistent with Forestier 's disease and extensive previously performed posterior laminectomy from C3 to C7 . Laminectomy was performed , according to the patient , because of underlying degenerative disease . Computed tomographic angiography -LRB- CTA -RRB- revealed disruption of the vertebral arteries bilaterally at the level of C2 -- C3 -LRB- Fig. 2 -RRB- . However , flow was identified in the basilar artery indicating a patent posterior circle of Willis providing back flow to the basilar artery and the posterior circulation . No MRI could be obtained due to the presence of a previously implanted cardiac pacemaker . Fig. 1Plain lateral X-rays of the cervical spine demonstrating a complete C2 -- C3 dislocation upon the patient 's admissionFig . 2Computed tomographic angiography obtained at patient 's admission demonstrating bilateral complete disruption of vertebral arteries The patient was placed in cervical traction with tongs under radiologic guidance for verifying alignment . The weight applied was gradually increased up to twelve pounds ; at that point , fluoroscopic imaging demonstrated a significant improvement in the angulation of the two separate segments and a reduction of the degree of subluxation . However , a subluxation of approximately 50 % of the cervical spine vertebral body length was still present -LRB- Fig. 3 -RRB- . Upon reversal of sedation , the patient had spontaneous eye opening and was able to follow commands . His upper and lower extremities ' muscle strength was 3/5 . The treatment plan for this patient consisted of a two stage 360o stabilization and fusion . Fig. 3Plain lateral X-rays of the cervical spine on the same patient obtained after applying external traction via tongs , demonstrating sub-optimal realignment of his cervical spine Shortly after his arrival to our hospital , the patient started to experience respiratory difficulties , leading the authors to the decision to delay surgery until the respiratory condition of the patient was stabilized . Two days after his admission , anterior cervical discectomy and fusion -LRB- ACDF -RRB- with the standard Smith-Robinson technique and bone allograft was performed at the C2 -- C3 level . A 24 mm Synthes -LRB- Paoli , PA , USA -RRB- statue plate was utilized after appropriate bending in order to contour the curvature of the cervical spine . Intraoperatively , disruption of the anterior longitudinal ligament at the C2 -- C3 level as well as fracture of the anterior osteophytic bony bridges , were evident . The vertebral endplates of the vertebral bodies at that level were severely degenerated . At the conclusion of the case , adequate reduction , satisfactory alignment and stabilization of the anterior cervical spine were accomplished . A halo vest was applied post-operatively for additional stabilization , necessary for the aggressive physical therapy that the patient 's respiratory condition demanded . Post-operative X-rays demonstrated reduction of the dislocation of C2 with respect to C3 and anatomic alignment of the structures of the cervical spine . The patient 's neurological condition remained unchanged during the following days . Respiratory distress was however noted , and a few days later , the patient was diagnosed with pneumonia . Appropriate treatment with antibiotics was initiated and it was decided to delay the second , posterior surgical approach until the patient 's respiratory condition was stabilized and his pneumonia resolved . Eighteen days after the initial operation , a second , posterior approach was employed . Under general endotracheal anesthesia , through a midline skin incision , a posterior cervical fusion and instrumentation -LRB- Synthes , Paoli , PA , USA -RRB- with pedicle screws at C2 level -LRB- 20 mm long and 4 mm in diameter -RRB- and lateral mass screws -LRB- 12 mm in length and 3.5 mm in diameter -RRB- at C3 level was undertaken . After optimal position of the screws was fluoroscopically verified , a 40 mm rod was used , which was attached and secured on a C2 and a C3 screw . Allograft bone chips were then appropriately placed -LRB- Fig. 4 -RRB- . The patient was placed back in the halo post-operatively due to his age and some concerns regarding osteoporosis . The halo vest was kept for four weeks after the second operation . He was finally discharged from the hospital to a rehabilitation clinic 24 days after admission . His neurologic status was essentially unchanged , with a muscle strength 3/5 in the upper and lower extremities . Fig. 4Post-operative lateral X-rays on the same patient after completion of anterior and posterior fusion The patient was followed at a different institution . At the last follow-up visit , 12 months postoperatively , his neurological status showed improvement with muscle strength of 4/5 in the upper and lower extremities . -LRB- Fig. 5a , b -RRB- Fig. 5a Post-operative CT -LRB- 3D reformatted midsagittal image -RRB- of the cervical spine demonstrating adequate anatomical alignment at the C2 -- C3 level . b Post-operative CT -LRB- 3D reformatted midsagittal image -RRB- of the cervical spine demonstrating adequate anatomical alignment at the C2 -- C3 level Discussion Injury of the cervical spine is a potentially fatal and debilitating incident due to the risk of damage of the cervical spinal cord . Although the degree of subluxation does not necessarily correlate with clinical symptoms and neurological signs , one would agree that the patient described above presented with unusually mild symptomatology in regards to the complete dislocation of the cervical vertebrae of the C2 -- C3 level , evident in his radiological examination . In reviewing the possible parameters related to this patient 's favorable outcome , attention should be drawn to the posterior cervical laminectomy previously performed on our patient due to underlying degenerative disease . It is quite likely that the lack of dorsal spinal elements of the C3 level , provided for adequate space for the posterior dislocation of the spinal cord to occur without sustaining the anticipated injury due to compression . This must have been of great importance both during the injury itself , as well as , after the dislocation had been established . Interestingly , Fountas et al. -LSB- 5 -RSB- noted in their study using postmyelogram computed tomographic measurements , that the cervical spinal cord might be smaller than considered . Specifically , they found that the diameter of the cervical spinal cord was 15 -- 20 % smaller than has been reported by autopsy studies . A smaller cervical spinal cord would also be less susceptible to injury due to compression . Although this is an interesting point that should perhaps be taken into consideration when referring to compression of the cervical spinal cord , its role in our case of a complete dislocation of the cervical spine could not have been , by itself , determinant without the history of previous laminectomy . On the other hand , the removal of the posterior arc of the vertebral bone may have predisposed for the development of such a complete dislocation . Hansen-Schwartz et al. -LSB- 7 -RSB- observed that 26 % of patients developed static subluxation at the cervical spine 7.7 ± 0.6 years after cervical laminectomy . Cusick et al -LSB- 2 -RSB- , in a cadaveric study examining the biomechanical responses of the cervical spine to laminectomy , concluded that multilevel cervical laminectomy induces increases in total column flexibility , allowing additional motion in the flexion-extension plane . This observation may well describe the mechanism of injury in our case in which extension of C2 -- C3 induced a posterior dislocation and was not limited to a severe sprain . Likewise , Hong-Wan et al. -LSB- 8 -RSB- noted in their biomechanical study a significant increase in intersegmental motions following cervical laminectomy . Furthermore , Fields et al. -LSB- 4 -RSB- observed in their randomized study comparing the effects of laminectomy and laminoplasty in the rabbit , that laminectomized animals had poorer clinical outcome at 3 months post-operatively , associated with statistically significant angular deformity . Similarly , Baisden et al. -LSB- 1 -RSB- , using a goat model , concluded that laminoplasty is superior to laminectomy in maintaining sagittal cervical alignment and preventing spinal deformities . The removal of bony and ligamentous structures of the posterior cervical spine might alter the biomechanics of the vertebral column and predispose to instability . The involvement of the C2 -- C3 level in our patient which coincides with the transition from non-laminectomized to laminectomized segments raises further suspicion regarding the putative role of laminectomy in the mechanism of injury in our case . Finally , the presence of osteophytes in the anterior cervical column in our patient -LRB- Forestier 's disease -RRB- could predispose to injury ; more severe neurologic deficits have been described in patients with diffuse idiopathic skeletal hyperostosis even following minor trauma -LSB- 15 -RSB- . It is interesting to note that our patient had no signs of posterior fossa infarction despite the fact that both of his vertebral arteries were disrupted at the C2 -- C3 level . We assume that this is because of the presence of fetal circulation in this patient providing back flow to the basilar artery as this was demonstrated in his CTA , thus maintaining adequate perfusion of the posterior fossa -LSB- 9 -RSB- . Treatment of subaxial cervical spinal injury remains controversial . Both the anterior and posterior procedures have serious advantages and disadvantages -LSB- 6 , 10 , 13 -RSB- . In our case , we decided to perform a combined anterior and posterior surgical procedure , since both the anterior and posterior longitudinal ligaments were disrupted and we felt that a circumferential approach would sufficiently restore the lost stability . Furthermore , the presence of disc fragments compromising the spinal canal could not be ruled out , due to the inability to obtain an MRI in our patient . A posterior approach , thus , without anterior stabilization was considered to harbor an increased risk of spinal cord compromise . It needs to be emphasized that further multiinstitutional prospective clinical studies are required in order to establish guidelines for the management of subaxial cervical spine injury . Conclusion In conclusion , we have reported a rare case of complete C2 -- C3 dislocation with unexpectedly mild neurological symptoms in a patient who had previously undergone a C3 -- C7 laminectomy . The previously performed laminectomy might have both predisposed and protected the patient 's spinal cord from severe injury .

O O O O O O O O B O O O O O 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 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 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 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 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 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 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 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 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 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 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 O 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 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 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 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 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 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 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 O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O 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 O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O