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Data Supplement 39. Renal Dysfunction

Study Name

Aim of Study

Study Type

Study

Patient Population/Inclusion &

Endpoints

Statistical

P-Values & 95%

OR / HR / RR

Study Summary

 

 

 

Size

Exclusion Criteria

 

 

Analysis

CI

 

 

 

 

 

 

 

 

 

 

Reported

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Inclusion Criteria

Exclusion

Primary

Secondary

 

 

 

 

 

 

 

 

 

Criteria

Endpoint

Endpoint

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Renal failure

Identify the

Retrospective

649

All cardiac surgery

N/A

ARF, ARF-

N/A

Multivariate

Cardiac

Cardiac

Cardiac catheterization within 5

after cardiac

relationship

single center

 

patients on

 

D, hospital

 

 

catheterization

catheterization

d of cardiac operation, baseline

surgery:

between

 

 

dialysis, cardiac

 

mortality

 

 

within 5 d;

within 5 d OR:

preoperative renal dysfunction,

timing of

timing of

 

 

transplant, VAD,

 

 

 

 

p=0.010; 95% CI:

1.82; baseline

prolonged CPB time are

cardiac

preoperative

 

 

emergency, aortic

 

 

 

 

1.17 to 2.84;

GFR <60 mL/min

significant risk factors for ARF.

catheterizatio

cardiac

 

 

dissection.

 

 

 

 

baseline GFR

1.69.

 

n and other

catheterization

 

 

 

 

 

 

 

<60 mL/min;

 

 

perioperative

and incidence

 

 

 

 

 

 

 

p=0.047; 95% CI:

 

 

risk factors.

of

 

 

 

 

 

 

 

1.09 to 2.62

 

 

2007 (272)

postoperative

 

 

 

 

 

 

 

 

 

 

 

ARF

 

 

 

 

 

 

 

 

 

 

The effect of

To assess the

Single center

395

CABG on-pump

Patients on

ARF

Perioperative

Multivariate

1 d interval

<1 d interval OR:

CABG should be delayed in the

cardiac

effect of

retrospective

 

 

dialysis and

 

mortality,

 

p=0.07; 95% CI:

3.7; eClCr <60

presence of high contrast dose

angiography

timing of

 

 

 

salvage

 

ICU and

 

1.4 to 8.3; ClCr

mL/min; OR: 7.1

and preoperative renal

timing,

cardiac

 

 

 

operations,

 

hospital stay

 

<60 mL/min;

 

dysfunction for at least 5 d after

contrast

angiography

 

 

 

referred from

 

 

 

95% CI: 3 to 16;

 

cardiac catheter

media dose,

and prevalence

 

 

 

OSH.

 

 

 

p<0.001

 

 

and

of ARF after

 

 

 

 

 

 

 

 

 

 

preoperative

cardiac

 

 

 

 

 

 

 

 

 

 

renal function

surgery

 

 

 

 

 

 

 

 

 

 

on ARF after

 

 

 

 

 

 

 

 

 

 

 

CABG. 2010

 

 

 

 

 

 

 

 

 

 

 

(273)

 

 

 

 

 

 

 

 

 

 

 

Influence of

Identify the

Single center

423

Elective on-pump

Preop dialysis,

ARF

 

Multivariate

Same day cardiac

Same day cardiac

Cardiac surgery and

the Timing of

influence of

retrospective

 

cardiac surgery

emergent/urge

 

 

 

catheterization/su

catheterization

catheterization same d increased

Cardiac

timing of

 

 

 

nt surgery/off-

 

 

 

rgery p=0.039;

/surgery; OR:

risk 3-fold for ARF

Catheterizatio

cardiac

 

 

 

pump

 

 

 

95% CI: 1.06 to

3.05

 

n and the

catheter and

 

 

 

 

 

 

 

8.78

 

 

Amount of

ARF after

 

 

 

 

 

 

 

 

 

 

Contrast

cardiac

 

 

 

 

 

 

 

 

 

 

Media on

surgery

 

 

 

 

 

 

 

 

 

 

Acute Renal

 

 

 

 

 

 

 

 

 

 

 

Failure After

 

 

 

 

 

 

 

 

 

 

 

© American College of Cardiology Foundation and American Heart Association, Inc.

Cardiac Surgery. 2008 (274)

ARF, acute renal failure; ARF-D, acute renal failure-dialysis; CABG, coronary artery bypass graft; CI, confidence interval; CPB, cardiopulmonary bypass; d, day; eCrCl, estimated creatinine clearance; GFR, glomerular filtration rate; HR, hazard ratio; ICU, intensive care unit; N/A, not applicable; OR, odds ratio; RR, relative risk; and VAD, ventricular assist device.

Data Supplement 40. Perioperative Bleeding/Transfusion

Study Name

Aim of Study

Study Type

Study

Patient Population/Inclusion &

Endpoints

Statistical Analysis

P

OR /

Study Summary

Study Limitations

 

 

 

Size

Exclusion Criteria

 

 

Reported

Values

HR /

 

 

 

 

 

 

 

 

 

 

 

& 95%

RR

 

 

 

 

 

 

 

 

 

 

 

CI

 

 

 

 

 

 

 

Inclusion

Exclusion

Primary

Secondary

 

 

 

 

 

 

 

 

 

Criteria

Criteria

Endpoint

Endpoint

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Preoperative

To investigate

Retrospectiv

111

CABG patients

Not CABG

Bleeding

N/A

Greater percentage

p=0.001

N/A

Increased blood loss

Median time interval for

Use of

if the use of

e

 

 

patients

events

 

of patients on

 

 

and reoperative for

discontinued LMWH was

Enoxaparin

LMWH or

 

 

 

 

 

 

LMWH required

 

 

bleeding in the

21 h.

increases the

PLT inhibitors

 

 

 

 

 

 

mediastinal re-

 

 

LMWH group.

 

Risk of

increased the

 

 

 

 

 

 

exploration for

 

 

 

 

Postoperative

risk of

 

 

 

 

 

 

nonsurgical

 

 

 

 

Bleeding and

bleeding in

 

 

 

 

 

 

bleeding versus

 

 

 

 

reexploration

CABG.

 

 

 

 

 

 

control (17% vs.

 

 

 

 

in cardiac

 

 

 

 

 

 

 

0% , respectively).

 

 

 

 

surgery

 

 

 

 

 

 

 

 

 

 

 

 

patients. 2005

 

 

 

 

 

 

 

 

 

 

 

 

(275)

 

 

 

 

 

 

 

 

 

 

 

 

© American College of Cardiology Foundation and American Heart Association, Inc.

Preoperative

To investigate

Retrospectiv

1159

Patients

1) The patient

Bleeding

 

Re-exploration was

p=0.03

HR:

Enoxaparin

N/A

use of

if the use of

e

 

presented with a

received no

events

 

7.9% in the

 

2.6

administration within

 

enoxaparin

LMWH

 

 

diagnosis of UA

antithrombotic

 

 

enoxaparin group

 

 

48 h of surgery

 

compared

compared with

 

 

or non Q–wave

therapy (UFH or

 

 

and 3.7% in the

 

 

increases the risk of

 

with UFH

UFH increased

 

 

MI and (2) the

enoxaparin) within

 

 

UFH group.

 

 

reoperative bleeding.

 

increases the

the risk of

 

 

patient received

48 h of the

 

 

 

 

 

 

 

incidence of

bleeding in

 

 

antithrombotic

surgical procedure

 

 

 

 

 

 

 

re-exploration

cardiac

 

 

therapy with

and 2) follow-up

 

 

 

 

 

 

 

for

surgery

 

 

either UFH or

clinical data were

 

 

 

 

 

 

 

postoperative

 

 

 

enoxaparin

not available

 

 

 

 

 

 

 

bleeding after

 

 

 

within 48 h

 

 

 

 

 

 

 

 

open-heart

 

 

 

before

 

 

 

 

 

 

 

 

surgery in

 

 

 

proceeding to

 

 

 

 

 

 

 

 

patients who

 

 

 

surgery

 

 

 

 

 

 

 

 

present with

 

 

 

 

 

 

 

 

 

 

 

 

an ACS:

 

 

 

 

 

 

 

 

 

 

 

 

clinical

 

 

 

 

 

 

 

 

 

 

 

 

investigation

 

 

 

 

 

 

 

 

 

 

 

 

and reports.

 

 

 

 

 

 

 

 

 

 

 

 

2002 (276)

 

 

 

 

 

 

 

 

 

 

 

 

Effects of

To investigate

Retrospectiv

161

CABG patients

Not CABG

Bleeding

 

Compared with

p<0.05

N/A

LMWH given <12 h

N/A

preoperative

the effects of

e

 

 

patients

events

 

UFH group,

 

 

increased the

 

enoxaparin

LMWH on

 

 

 

 

 

 

LMWH, <12 group

 

 

transfusion rate and

 

vs. UFH on

bleeding

 

 

 

 

 

 

had higher

 

 

number of PRBC

 

bleeding

indices and

 

 

 

 

 

 

transfusion rate

 

 

transfused per patient

 

indices in

transfusion

 

 

 

 

 

 

(73.5% vs. 50.7%,

 

 

 

 

patients

rates in

 

 

 

 

 

 

respectively),

 

 

 

 

undergoing

patients

 

 

 

 

 

 

 

 

 

 

 

CABG. 2003

undergoing

 

 

 

 

 

 

 

 

 

 

 

(277)

cardiac

 

 

 

 

 

 

 

 

 

 

 

 

surgery

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Preoperative

To investigate

Retrospectiv

64

CABG patients

Not CABG

Bleeding

N/A

62% of pts

p=0.8

N/A

LMWH given <10 h

Number of patients

use of

if the use of

e

 

 

patients

events

 

transfused in the

 

 

does not increase the

receiving LMWH was

enoxaparin is

LMWH

 

 

 

 

 

 

LMWH vs. 60% in

 

 

transfusion rate and

only 21. High transfusion

not a risk

increased the

 

 

 

 

 

 

the control

 

 

number of PRBC

rate in the control group.

factor for

risk of

 

 

 

 

 

 

 

 

 

transfused per patient

 

postoperative

bleeding in

 

 

 

 

 

 

 

 

 

 

 

bleeding after

CABG

 

 

 

 

 

 

 

 

 

 

 

CABG. 2003

 

 

 

 

 

 

 

 

 

 

 

 

(278)

 

 

 

 

 

 

 

 

 

 

 

 

© American College of Cardiology Foundation and American Heart Association, Inc.

ACS indicates acute coronary syndrome; CABG, coronary artery bypass graft; CI, confidence interval; h, hour; HR, hazard ratio; LMWH, low molecular weight heparin; MI, myocardial infarction; N, number; N/A, not applicable; OR, odds ratio; PLT, platelet inhibitors; PRBC, packed red blood cells; RR, relative risk; UFH, unfractionated heparin; and UA, unstable angina.

Data Supplement 41. Perioperative Bleeding/Transfusion

Article Title

Aim of Study

Study

Patient

Patient Population/Inclusion & Exclusion

Endpoints

Statistical Analysis

95% CI;

OR/HR/

Study Summary

 

 

Type

Size

Criteria

 

 

Reported

P-Values

RR

 

 

 

 

 

Inclusion Criteria

Exclusion Criteria

Primary

Secondary

 

 

 

 

 

 

 

 

 

 

Endpoint

Endpoint

 

 

 

 

A

To compare

RCT

50

Patients who were

An age of <30 y or >80

Graft patency

Clinical outcomes

Patients in the on-pump

p=0.004

N/A

N/A

randomized

graft-patency

 

 

referred for

y; an indication for

 

 

group were more likely to

 

 

 

comparison

rates and

 

 

isolated, first-time

additional surgical

 

 

receive packed-cell

 

 

 

of off-pump

clinical

 

 

coronary-artery

procedures;

 

 

transfusion (p=0.004) or

 

 

 

and on-

outcomes in

 

 

surgery and who

documented stroke

 

 

clotting-product

 

 

 

pump multi-

off-pump

 

 

required at least 3

within the preceding 6

 

 

transfusion (p=0.002). The

 

 

 

vessel

surgery with

 

 

grafts were

mo; carotid-artery

 

 

mean blood loss was not

 

 

 

CABG.

conventional,

 

 

eligible.

stenosis of more than

 

 

significantly different

 

 

 

2004 (279)

"on-pump"

 

 

 

70%; documented MI

 

 

between the 2 groups (898

 

 

 

 

surgery.

 

 

 

in the preceding 3 mo;

 

 

mL in the on-pump group

 

 

 

 

 

 

 

 

poor LV function, with

 

 

and 1,031 mL in the off-

 

 

 

 

 

 

 

 

an EF <20%;

 

 

pump group).

 

 

 

 

 

 

 

 

pregnancy and breast-

 

 

 

 

 

 

 

 

 

 

 

feeding; an inability to

 

 

 

 

 

 

 

 

 

 

 

provide written

 

 

 

 

 

 

 

 

 

 

 

informed consent; and

 

 

 

 

 

 

 

 

 

 

 

a history of

 

 

 

 

 

 

 

 

 

 

 

complications after

 

 

 

 

 

 

 

 

 

 

 

diagnostic

 

 

 

 

 

 

 

 

 

 

 

angiography.

 

 

 

 

 

 

Early

To compare

Random

281

Patients were

Patients were excluded

Cardiac

Improvement in

The intraoperative use of

95% CI:

N/A

Concluded that in

outcome

the short term

ized

 

eligible if referred

in case of emergency or

outcome 1 mo

quality of life at 1

blood products was

4 to 17;

 

selected patients, off-

after off-

clinical

Multice

 

for first-time

concomitant major

after surgery

mo.

reduced in the off-pump

p<0.01

 

pump CABG is safe

pump vs.

outcomes of

nter

 

isolated coronary

surgery, Q-wave MI in

(defined as

 

group. The proportion of

 

 

and yields a short-term

on-pump

OPCAB with

Trial

 

bypass surgery and

the previous 6 w, or

survival free of

 

patients in whom blood

 

 

cardiac outcome

coronary

standard on-

 

 

an off-pump

poor LV function or if

CV events,

 

products were used during

 

 

comparable to that of

bypass

pump CABG.

 

 

procedure was

they were unlikely to

which included

 

surgery was almost 4 times

 

 

on-pump CABG.

surgery:

 

 

 

deemed technically

complete 1 y of follow-

stroke, MI, and

 

lower in the off-pump

 

 

 

results from

 

 

 

feasible.

up or unable to give

coronary

 

group (3% for OPCAB vs.

 

 

 

a

 

 

 

 

informed consent.

intervention).

 

13% for on-pump CABG,

 

 

 

randomized

 

 

 

 

There were no

 

 

p<0.01).

 

 

 

study. 2001

 

 

 

 

restrictions as to age.

 

 

 

 

 

 

(280)

 

 

 

 

 

 

 

 

 

 

 

© American College of Cardiology Foundation and American Heart Association, Inc.

Early and

To pool the

Pooled

401

Patients

Recent MI within 1

The primary

Noncardiac events,

Analyses of combined data

95% CI:

RR: 0.36

In general, study

midterm

results of 2

outcom

 

undergoing off-

mo; had a history of

endpoint for this

such as chest or

from both trials showed

0.26 to

 

concluded off-pump

outcome

RCT to assess

e of 2

 

pump or on-pump

supraventricular

pooled analysis

wound infection, and

transfusion of red blood

0.51;p<0.

 

coronary surgery

after off-

midterm

RCT

 

CABG.

arrhythmia; had a

was all cause

neurological events.

was 31% lower in OPCAB

0001

 

significantly lowers in-

pump and

outcomes of

(which

 

 

previous CABG; had

mortality or a

 

pages compared to on-

 

 

hospital morbidity

on-pump

OPCAB.

compar

 

 

renal or respiratory

cardiac-related

 

pump CABG.

 

 

without compromising

surgery in

 

ed short

 

 

impairment; or had a

event at

 

 

 

 

outcome in the first 1 to

Beating

 

term

 

 

previous stroke, TIA,

midterm follow-

 

 

 

 

3 y after surgery

Heart

 

morbidi

 

 

or coagulopathy

up (1 to 3 y after

 

 

 

 

compared with

Against

 

ty of

 

 

present.

surgery).

 

 

 

 

conventional on-pump

Cardioplegic

 

OPCAB

 

 

 

 

 

 

 

 

coronary surgery.

Arrest

 

vs. on-

 

 

 

 

 

 

 

 

 

Studies

 

pump

 

 

 

 

 

 

 

 

 

(BHACAS1

 

CABG)

 

 

 

 

 

 

 

 

 

and 2): a

 

to

 

 

 

 

 

 

 

 

 

pooled

 

assess

 

 

 

 

 

 

 

 

 

analysis of 2

 

midterm

 

 

 

 

 

 

 

 

 

RCTs. 2002

 

outcom

 

 

 

 

 

 

 

 

 

(222)

 

es.

 

 

 

 

 

 

 

 

 

OPCAB

To compare

RCT

200

Patients referred

Patients in cardiogenic

Completeness of

In-hospital and 30-d

Patients undergoing

p=0.0073

OR: 2.42

In general, when

grafting

completeness

 

 

for elective

shock and those

revascularizatio

outcomes, LOS,

OPCAB received fewer

 

 

compared with

provides

of

 

 

primary CABG

requiring preoperative

n.

transfusion

units of blood, were more

 

 

conventional CABG

complete

revascularizati

 

 

 

IABP counterpulsation

 

requirements, and

likely to avoid transfusion

 

 

with CPB, OPCABG

revasculariz

on, clinical

 

 

 

were excluded from the

 

extent of myocardial

altogether and had a higher

 

 

achieved similar

ation with

outcomes, and

 

 

 

study for cardiac

 

injury.

hematocrit at discharge.

 

 

completeness of

reduced

resource use in

 

 

 

reasons. Patients who

 

 

CPB was an independent

 

 

revascularization,

myocardial

unselected

 

 

 

had chronic renal

 

 

predictor of transfusion

 

 

similar in-hospital and

injury,

patients

 

 

 

insufficiency with a

 

 

(OR: 2.42; p=0.0073) by

 

 

30-d outcomes, shorter

transfusion

referred for

 

 

 

creatinine level greater

 

 

multivariate analysis.

 

 

LOS, reduced

requirements

elective,

 

 

 

than 2.5 mg/dL were

 

 

 

 

 

transfusion

, and LOS: a

primary

 

 

 

eligible for enrollment

 

 

 

 

 

requirement, and less

prospective

CABG

 

 

 

in the study but were

 

 

 

 

 

myocardial injury.

randomized

randomly

 

 

 

exempt from having

 

 

 

 

 

 

comparison

assigned to

 

 

 

postoperative cardiac

 

 

 

 

 

 

of 200

undergo

 

 

 

angiography

 

 

 

 

 

 

unselected

OPCAB with

 

 

 

performed.

 

 

 

 

 

 

patients

an Octopus

 

 

 

 

 

 

 

 

 

 

undergoing

tissue

 

 

 

 

 

 

 

 

 

 

off-pump vs.

stabilizer

 

 

 

 

 

 

 

 

 

 

conventional

(Medtronic,

 

 

 

 

 

 

 

 

 

 

coronary

Inc,

 

 

 

 

 

 

 

 

 

 

artery

Minneapolis,

 

 

 

 

 

 

 

 

 

 

© American College of Cardiology Foundation and American Heart Association, Inc.

bypass

Minn) or

 

 

 

 

 

 

 

 

 

 

grafting

CABG with

 

 

 

 

 

 

 

 

 

 

(281).

CPB.

 

 

 

 

 

 

 

 

 

 

Complete

To evaluate

RCT

80

Inclusion criteria

Diffuse disease,

Completeness of

Parameters of

Although no significant

p=NS

N/A

In general, the study

revasculariz

the feasibility

 

 

were a normal or

ventricular

revascularizatio

clinical outcome

differences in bleeding

 

 

concluded OPCAB is

ation in

of CABG

 

 

almost unimpaired

hypertrophy, and

n

 

complications were

 

 

effective for complete

coronary

without CPB

 

 

LVEF and

cardiac enlargement

 

 

reported, 1 (2.5%)

 

 

revascularization in the

artery

to achieve

 

 

presence of

 

 

 

reexploration occurred

 

 

majority of selected

bypass

complete

 

 

coronary

 

 

 

because of bleeding in a

 

 

low-risk patients,

grafting with

revascularizati

 

 

multivessel

 

 

 

patient without CPB and 2

 

 

although the rate of

and without

on as

 

 

disease.

 

 

 

(5.0%) reexplorations

 

 

incomplete

CPB. 2001

compared with

 

 

 

 

 

 

occurred in patients with

 

 

revascularization in this

(282)

the standard

 

 

 

 

 

 

CPB.

 

 

early series of CABG

 

operation with

 

 

 

 

 

 

 

 

 

without CPB was

 

CPB in

 

 

 

 

 

 

 

 

 

higher.

 

selected low-

 

 

 

 

 

 

 

 

 

 

 

risk patients.

 

 

 

 

 

 

 

 

 

 

Does

To determine

Meta-

3,369

Studies were

Hybrid (i.e., OPCAB

All-cause

Postoperative

OPCAB significantly

95% CI:

OR: 0.43

In general, selected

OPCAB

whether

Analysi

 

included if they

plus balloon

mortality at 30

incidence of stroke,

decreased transfusion

0.29 to

 

short-term and mid-

reduce

OPCAB

s

 

met each of the

angioplasty) and

d, 6 mon, and

acute MI, AF, renal

requirements.

0.65;

 

term clinical and

mortality,

reduces

 

 

following

robotically assisted

>1 y.

failure, need for

 

p<0.0001

 

resource outcomes were

morbidity,

mortality,

 

 

conditions:

surgery studies were

 

inotropes, need for

 

 

 

improved compared

and resource

morbidity, or

 

 

randomized

excluded.

 

intraaortic balloon

 

 

 

with conventional

utilization

resource

 

 

allocation to

 

 

pump,

 

 

 

CABG.

when

utilization

 

 

OPCAB on the

 

 

mediastinitis/wound

 

 

 

 

compared

when

 

 

beating heart vs.

 

 

infection, respiratory

 

 

 

 

with

compared with

 

 

conventional

 

 

infections, angina

 

 

 

 

conventional

standard

 

 

CABG on the

 

 

recurrence,

 

 

 

 

coronary

CABG.

 

 

asystolic heart with

 

 

reintervention for

 

 

 

 

artery

 

 

 

CPB circuit, adult

 

 

ischemia, restenosis,

 

 

 

 

bypass? A

 

 

 

patients undergoing

 

 

need for

 

 

 

 

meta-

 

 

 

singleor multiple-

 

 

transfusions,

 

 

 

 

analysis of

 

 

 

vessel bypass, and

 

 

reexploration for

 

 

 

 

randomized

 

 

 

reporting at least 1

 

 

bleeding,

 

 

 

 

trials. 2005

 

 

 

pertinent clinical or

 

 

neurocognitive

 

 

 

 

(283)

 

 

 

economic outcome.

 

 

dysfunction, duration

 

 

 

 

 

 

 

 

Off-pump studies

 

 

of ventilation, ICU

 

 

 

 

 

 

 

 

using minimally

 

 

LOS, hospital LOS,

 

 

 

 

 

 

 

 

invasive direct

 

 

hospital costs, and

 

 

 

 

 

 

 

 

coronary artery

 

 

QOL.

 

 

 

 

 

 

 

 

bypass with

 

 

 

 

 

 

 

 

 

 

 

thoracotomy and

 

 

 

 

 

 

 

© American College of Cardiology Foundation and American Heart Association, Inc.

 

 

 

 

studies allowing

 

 

 

 

 

 

 

 

 

 

 

for ventricular

 

 

 

 

 

 

 

 

 

 

 

assist devices were

 

 

 

 

 

 

 

 

 

 

 

included with the

 

 

 

 

 

 

 

 

 

 

 

intent of

 

 

 

 

 

 

 

 

 

 

 

subanalyzing these

 

 

 

 

 

 

 

 

 

 

 

groups. Blinded

 

 

 

 

 

 

 

 

 

 

 

and unblinded

 

 

 

 

 

 

 

 

 

 

 

studies were

 

 

 

 

 

 

 

 

 

 

 

included.

 

 

 

 

 

 

 

Impact of

To evaluate

Review

N/A

All blinded or

Studies reporting on

Blood loss.

Transfusion

N/A

N/A

N/A

Evidence clearly

off-pump

current best

article

 

unblinded RCTs

outcomes of hybrid

 

requirements

 

(values

 

suggests that there is

CABG on

available

on

 

comparing OPCAB

(i.e., OPCAB plus

 

 

 

for

 

less bleeding with off-

postoperativ

evidence from

RCT's.

 

or MIDCAB on the

balloon angioplasty)

 

 

 

individua

 

pump procedures

e bleeding:

RCTs to assess

 

 

beating heart with

procedures,

 

 

 

l studies

 

compared with CPB

current best

the impact of

 

 

conventional

robotically assisted

 

 

 

reported)

 

and there is less need

available

OPCAB on

 

 

CABG on CPB

surgery or using

 

 

 

 

 

for blood products.

evidence.

postoperative

 

 

using cardioplegic

circulatory assist

 

 

 

 

 

 

2006 (284)

blood loss and

 

 

arrest, recruiting

devices were excluded.

 

 

 

 

 

 

 

transfusion

 

 

adult patients

 

 

 

 

 

 

 

 

requirements.

 

 

undergoing single-

 

 

 

 

 

 

 

 

 

 

 

or multiple-vessel

 

 

 

 

 

 

 

 

 

 

 

bypass, and

 

 

 

 

 

 

 

 

 

 

 

reporting at least 1

 

 

 

 

 

 

 

 

 

 

 

pertinent clinical or

 

 

 

 

 

 

 

 

 

 

 

economic outcome

 

 

 

 

 

 

 

 

 

 

 

were retrieved. Out

 

 

 

 

 

 

 

 

 

 

 

of these, RCTs

 

 

 

 

 

 

 

 

 

 

 

reporting on

 

 

 

 

 

 

 

 

 

 

 

postoperative blood

 

 

 

 

 

 

 

 

 

 

 

loss were included

 

 

 

 

 

 

 

 

 

 

 

for this systematic

 

 

 

 

 

 

 

 

 

 

 

review.

 

 

 

 

 

 

 

AF indicates atrial fibrillation; CI, confidence interval; CPB, cardiopulmonary bypass; CV, cardiovascular; EF, ejection fraction; HR, hazard ratio; IABP, intra aortic balloon pump; LOS, length of stay; LV, left ventricular; LVEF, left ventricular ejection fraction; MI, myocardial infarction; MIDCAB, minimally invasive directed coronary artery bypass; N/A, not applicable; OPCAB, off-pump coronary artery bypass; OR, odds ratio; QOL, quality of life;RCT, randomized controlled trial; and RR, relative risk..

© American College of Cardiology Foundation and American Heart Association, Inc.

Data Supplement 42. Perioperative Bleeding/Transfusion

Study

Aim of

Study Type

Study

Patient Population/Inclusion

Endpoints

Statistical Analysis Reported

P Values &

OR / HR

Study Summary

Name

Study

 

Size

& Exclusion Criteria

 

 

 

95% CI

/ RR

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Inclusion

Exclusion

Primary

Secondary

 

 

 

 

 

 

 

 

Criteria

Criteria

Endpoint

Endpoint

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Blood

To define

Comparison of

1,261

Patients

Patients not

Incidence

ICU and

N/A

p<0.001

N/A

Adherence to defined transfusion

conservatio

strict

prospective data

 

undergoing

undergoing

of

hospital LOS

 

 

 

criteria alone is a simple, safe, and

n in

transfusion

with retrospective

 

isolated

isolated

postoperati

and

 

 

 

effective strategy for decreasing

coronary

criteria as the

data (data is

 

primary

primary

ve

reoperation

 

 

 

blood product utilization.

artery

sole blood

regarding blood

 

CABG.

CABG.

transfusion

for bleeding.

 

 

 

 

surgery.

conservation

product usage).

 

 

 

.

 

 

 

 

 

1994 (285)

strategy.

 

 

 

 

 

 

 

 

 

 

Efficacy of

To determine

RCT

92

Adult men

Patients

Transfusio

ICU blood

Adherence to a coagulation

p=0.0002

N/A

ICU mediastinal blood loss was

a simple

if coagulation

 

 

and

undergoing

n

loss.

test-based transfusion

(for FFP

 

significantly less in the algorithm

intraoperati

test-based

 

 

nonpregnant

nonelective

requiremen

 

algorithm in cardiac surgery

transfusion);

 

group. Multivariate analysis

ve

algorithms

 

 

adult

surgery or

ts.

 

patients with abnormal

p=0.0001

 

demonstrated that transfusion

transfusion

may reduce

 

 

women

undergoing

 

 

bleeding after CPB reduced

(for platelet

 

algorithm use resulted in reduced

algorithm

transfusion of

 

 

scheduled

surgery

 

 

nonerythrocyte allogeneic

transfusion)

 

ICU blood loss. The control group

for

nonerythrocyt

 

 

for elective

without CPB.

 

 

transfusions in the operating

 

 

also had a significantly greater

nonerythro

e allogeneic

 

 

cardiac

 

 

 

room and ICU blood loss. The

 

 

incidence of surgical reoperation of

cyte

blood in

 

 

surgery

 

 

 

transfusion algorithm group

 

 

the mediastinum for bleeding

component

patients with

 

 

requiring

 

 

 

received less allogeneic fresh

 

 

(11.8% vs. 0%; p=0.032).

utilization

abnormal

 

 

CPB.

 

 

 

frozen plasma in the operating

 

 

 

after CPB.

bleeding.

 

 

 

 

 

 

room after CPB (median: 0

 

 

 

2001 (286)

 

 

 

 

 

 

 

units; range: 0 to 7 units) than

 

 

 

 

 

 

 

 

 

 

 

the control group (median: 3

 

 

 

 

 

 

 

 

 

 

 

units; range: 0 to 10 units)

 

 

 

 

 

 

 

 

 

 

 

(p=0.0002). The median

 

 

 

 

 

 

 

 

 

 

 

number of platelet units

 

 

 

 

 

 

 

 

 

 

 

transfused in the operating

 

 

 

 

 

 

 

 

 

 

 

room after CPB was 4 (range:

 

 

 

 

 

 

 

 

 

 

 

0 to 12) in the algorithm group

 

 

 

 

 

 

 

 

 

 

 

compared with 6 (range: 0

 

 

 

 

 

 

 

 

 

 

 

to18) in the control group

 

 

 

 

 

 

 

 

 

 

 

(p=0.0001).

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

© American College of Cardiology Foundation and American Heart Association, Inc.

Reduced

Determine if

Pilot study to

60

Patients

Patients not

Reduced

Chest tube

Ten patients in the regular

p<0.005

N/A

Concluded that intraoperative

haemostati

the

investigate the

 

undergoing

undergoing

total

output

clinical group received a total

 

 

monitoring of coagulation in the

c factor

heparinase-

use of an

 

cardiac

cardiac

exposure

 

of 16 units of FFP and 9

 

 

anticoagulated patient can be used to

transfusion

modified

algorithm.

 

surgery.

surgery.

to

 

platelet concentrates

 

 

guide treatment.

using

thrombelasto

 

 

 

 

hemostatic

 

compared with 5 patients

 

 

 

heparinase-

gram using

 

 

 

 

component

 

transfused with 5 units of FFP

 

 

 

modified

anticoagulate

 

 

 

 

therapies.

 

and 1 platelet concentrate in

 

 

 

thrombelas

d blood from

 

 

 

 

 

 

the algorithm group. 12-h

 

 

 

tography

patients

 

 

 

 

 

 

chest tube losses [algorithm

 

 

 

during

during

 

 

 

 

 

 

group 470 (295 to 820) mL,

 

 

 

CPB. 2001

cardiac

 

 

 

 

 

 

clinically managed group 390

 

 

 

(287)

surgery could

 

 

 

 

 

 

(240 to 820) ml (median,

 

 

 

 

guide

 

 

 

 

 

 

quartile values)] were not

 

 

 

 

treatment

 

 

 

 

 

 

significantly different between

 

 

 

 

with

 

 

 

 

 

 

groups despite the 3-fold

 

 

 

 

haemostatic

 

 

 

 

 

 

reduction in the use of

 

 

 

 

components.

 

 

 

 

 

 

haemostatic products,

 

 

 

 

 

 

 

 

 

 

 

showing that intraoperative

 

 

 

 

 

 

 

 

 

 

 

monitoring of coagulation in

 

 

 

 

 

 

 

 

 

 

 

the anticoagulated patient can

 

 

 

 

 

 

 

 

 

 

 

be used to guide treatment.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

© American College of Cardiology Foundation and American Heart Association, Inc.

Compariso

To test the

RCT

102

Sequential

Patients with

Postoperati

Differences in

The median blood loss was

p<0.025

N/A

Concluded that algorithms based on

n of

hypothesis

 

 

patients for

preoperative

ve blood

the POC test

not significantly different

 

 

POC tests or on structured clinical

structured

that a mgmt

 

 

elective,

abnormal

loss and

results

among the groups in this

 

 

practice with standard laboratory

use of

algorithm

 

 

first time

clotting tests,

the

between the

study. Patients in the clinician

 

 

tests do not decrease blood loss, but

routine

based on

 

 

CABG

including INR

transfusion

groups using

discretion group received

 

 

reduce the transfusion of PRBCs

laboratory

near-patient

 

 

surgery with

>1.5, APTT

of PRBCs

POC

significantly more (p<0.025)

 

 

and blood components after routine

tests or

tests would

 

 

CPB treated

ratio >1.5 or

and blood

hemostatic

transfusions of blood

 

 

cardiac surgery, when compared

near-

reduce blood

 

 

by the same

platelet count

component

assessment

components (PRBCs, FFP and

 

 

with clinician discretion.

patient

loss and

 

 

surgical,

<150 X 10

s

and the group

pooled platelets) compared

 

 

 

assessment

blood

 

 

intensivist

E(9)/litre,

 

using

with those in the LAG and

 

 

 

with

component

 

 

and

were

 

standard

POC groups. There were no

 

 

 

clinical

use after

 

 

anaesthetic

excluded. Any

 

haematology

significant

 

 

 

judgment

routine

 

 

teams

medication

 

laboratory

differences in this regard

 

 

 

in the

coronary

 

 

 

affecting

 

tests LAG.

between the LAG and POC

 

 

 

manageme

artery surgery

 

 

 

coagulation

 

 

groups.

 

 

 

nt of

with CPB

 

 

 

within 72 h of

 

 

 

 

 

 

bleeding

when

 

 

 

surgery,

 

 

 

 

 

 

after

compared

 

 

 

including

 

 

 

 

 

 

cardiac

with an

 

 

 

warfarin,

 

 

 

 

 

 

surgery.

algorithm

 

 

 

heparin, low

 

 

 

 

 

 

2004 (288)

based on

 

 

 

molecular

 

 

 

 

 

 

 

routine

 

 

 

weight

 

 

 

 

 

 

 

laboratory

 

 

 

heparin,

 

 

 

 

 

 

 

assays or

 

 

 

aspirin and

 

 

 

 

 

 

 

with clinical

 

 

 

clopidogrel,

 

 

 

 

 

 

 

judgment.

 

 

 

was also an

 

 

 

 

 

 

 

 

 

 

 

exclusion

 

 

 

 

 

 

 

 

 

 

 

criterion.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

© American College of Cardiology Foundation and American Heart Association, Inc.