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monotonically from 7.25% to 2.85%.

 

 

 

 

 

 

Crude mortality rates decrease monotonically from

 

 

 

 

 

 

9.09% for annual surgeon volumes between 1 to 54 to

 

 

 

 

 

 

2.89% for annual surgeon volumes ≥260.

 

 

 

 

 

 

Risk-adjusted rates decrease from 8.14% for patients of

 

 

 

 

 

 

surgeons with volumes <55 to 2.43% for patients of

 

 

 

 

 

 

surgeons with volumes ≥260.

 

 

 

 

 

 

Best results (risk-adjusted mortality 2.18%) in hospitals

 

 

 

 

 

 

performing ≥890 cardiac operations in 1989 and from

 

 

 

 

 

 

surgeons performing ≥260 cardiac operations.

The decline in CABG

To examine the

Observational

57,187 isolated CABG

1989 to 1992/30 NY CABG

Risk adjusted mortality

Risk-adjusted in-hospital mortality decreased for all

mortality in New York State.

longitudinal relationship

 

patients

hospitals

 

surgeon volume categories.

The role of surgeon volume.

between surgeon volume

 

 

 

 

 

1995 (206)

and in-hospital mortality

 

 

 

 

Low-volume surgeons (≤50 CABG/y) had largest

 

for CABG in NY.

 

 

 

 

reduction (60%) in risk-adjusted mortality over 4-y.

 

To explain changes in

 

 

 

 

Highest-volume surgeons (>150 CABG/y) had 34%

 

mortality over time.

 

 

 

 

reduction.

 

 

 

 

 

 

Percentage of patients having CABG by low-volume

 

 

 

 

 

 

surgeons decreased from 7.6% in 1989 to 5.7% in 1992

 

 

 

 

 

 

(25% reduction).

 

 

 

 

 

 

Part of decrease due to exodus of low-volume surgeons

 

 

 

 

 

 

with high risk-adjusted mortality; better performance

 

 

 

 

 

 

of surgeons who were new to the system; and

 

 

 

 

 

 

performance of surgeons who were not consistently

 

 

 

 

 

 

low-volume surgeons.

Volume and outcome in

To assess impact of

Systematic

 

1972 to 1992

CABG mortality

All 7 studies reported reduced mortality with increased

CABG: true association or

case-mix on CABG

review

 

 

 

volume.

artifact? 1995 (207)

volume-outcome studies

 

 

7 studies of CABG volume-

 

 

 

 

 

 

outcome association

 

Studies with better case-mix adjustment indicated less

 

 

 

 

 

 

reduction in mortality with increased volume (p=0.04).

 

 

 

 

US data

 

 

 

 

 

 

 

 

Apparent advantages of higher volume decreased over

 

 

 

 

 

 

time (p<0.001).

Do hospitals and surgeons

To investigate the

Observational

57,150 isolated CABG

NY CABG patients/1997 to

Risk-adjusted in-hospital

Significantly lower risk-adjusted mortality rates

with higher CABG volumes

CABG volume outcome

 

patients

1999

mortality

observed above all annual hospital volume thresholds

still have lower risk-adjusted

association with

 

 

 

 

between 200 to 800 and above all surgeon volume

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

mortality rates? 2003 (208)

contemporary data.

 

 

Cardiac Surgery Reporting

 

thresholds between 50 to 200.

 

 

 

 

System

 

 

 

 

 

 

 

 

Risk-adjusted mortality rate for surgeons with volumes

 

 

 

 

 

 

of ≥125 in hospitals with volumes of ≥600 was 1.89%.

 

 

 

 

 

 

Risk-adjusted mortality significantly higher (2.67%)

 

 

 

 

 

 

for surgeons with volumes of <125 in hospitals with

 

 

 

 

 

 

volumes of <600.

Is the impact of hospital and

To determine if volume-

Observational

57,150 isolated CABG

NY CABG patients (Cardiac

Risk-adjusted in-hospital

For annual hospital volume thresholds between 200

surgeon volumes on the in-

outcome association

 

patients

Surgery Reporting

mortality

and 600 cases, adjusted ORs of mortality for high-

hospital mortality rate for

only valid for high-risk

 

 

System)/1997 to 1999.

 

volume to low-volume hospitals =0.45 to 0.77 (all

CABG limited to patients at

patients.

 

 

 

 

significant) for low-risk group.

high risk? 2004 (209)

 

 

 

 

 

 

 

 

 

 

 

 

For moderateto high-risk group, OR: 0.62 to 0.91

 

 

 

 

 

 

(most significant).

 

 

 

 

 

 

As annual surgeon volume threshold increased from 50

 

 

 

 

 

 

to 150 cases, ORs for highto low-volume surgeons

 

 

 

 

 

 

increased from 0.43 to 0.74 for low-risk group.

 

 

 

 

 

 

For the moderateto high-risk group, ORs ranged from

 

 

 

 

 

 

0.79 to 0.86. Compared with patients treated by

 

 

 

 

 

 

surgeons with volumes of <125 in hospitals with

 

 

 

 

 

 

volumes of <600, patients treated by higher-volume

 

 

 

 

 

 

surgeons in higher-volume hospitals had significantly

 

 

 

 

 

 

lower risk of death (OR: 0.52 for low-risk group).

 

 

 

 

 

 

Higher volume associated with better outcomes for all

 

 

 

 

 

 

risk groups.

Outcome as a function of

To determine association

Observational

124,793 CABG patients

Isolated CABG patients/1991

 

Variability of outcome was significant in lower volume

annual CABG volume. 1996

between risk-adjusted

 

 

to 1993/>600 US hospitals.

 

practices (<600 cases/y) and varied little at >600

(210)

CABG mortality and

 

 

 

 

cases/y.

 

volume.

 

 

STS-NCD

 

 

 

 

 

 

 

 

No practice volume category had an observed/expected

 

 

 

 

1,200 surgeons

 

ratio of less than 0.8 or >1.2 if annual volume was

 

 

 

 

 

 

>100.

 

 

 

 

 

 

Practices of <100 cases/y had an observed/expected

 

 

 

 

 

 

ratio of 1.6.

 

 

 

 

 

 

 

No continuous relationship

To determine association

Observational

23,986 CABG

CABG patients/April 1987 to

30-d risk-adjusted

No statistically significant relationship between CABG

between Veterans Affairs

between CABG volume

 

 

September 1992/44 VA

mortality

volume and risk-adjusted operative mortality (p=0.10).

hospital coronary artery

and outcome in VA

 

 

hospitals.

 

 

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

bypass grafting surgical

hospitals.

 

 

 

 

Using ANOVA, hospitals with ≤100 cases per y have

volume and operative

 

 

 

 

 

higher observed to expected mortality ratios than

mortality. 1996 (211)

 

 

 

 

 

hospitals performing >100 cases per y (p=0.03).

 

 

 

 

 

 

Using Poisson regression models, volume threshold not

 

 

 

 

 

 

found.

 

 

 

 

 

 

 

Hospital CABG volume and

To assess the volume-

Observational

228,738 CABG patients

1998 to 2000 Nationwide

In-hospital mortality by

Crude in-hospital mortality rates=4.21% in low volume

patient mortality, 1998 to

outcome association for

 

 

Inpatient Sample

hospital CABG volume

hospitals, 3.74% in medium-volume hospitals, and

2000. 2004 (212)

CABG

 

 

 

group (low=12 to 249

3.54% in high-volume hospitals (trend p<0.001).

 

 

 

 

 

cases/y, medium=250 to

 

 

 

 

 

 

499 cases/y, high ≥500

Compared with high-volume hospitals, patients at low-

 

 

 

 

 

cases/y)

volume hospitals had increased adjusted mortality risk

 

 

 

 

 

 

(OR: 1.26; 95% CI: 1.15 to 1.39), as did medium

 

 

 

 

 

 

volume hospitals (OR: 1.11; 95% CI: 1.01 to 1.21).

 

 

 

 

 

 

Considerable outcomes heterogeneity at every volume

 

 

 

 

 

 

level.

 

 

 

 

 

 

207 of 243 (85%) low-volume and 151 of 169 (89%)

 

 

 

 

 

 

medium-volume hospital-y had risk-standardized

 

 

 

 

 

 

mortality rates that were statistically lower or

 

 

 

 

 

 

comparable to expected.

 

 

 

 

 

 

Only 11 of 169 (6%) high-volume hospital-y had

 

 

 

 

 

 

outcomes that were statistically better than expected

 

 

 

 

 

 

and 18 of 161 (11%) high-volume hospital-y had worse

 

 

 

 

 

 

than expected risk-standardized mortality rates.

 

 

 

 

 

 

“Volume is not a reliable marker of hospital CABG

 

 

 

 

 

 

quality”.

Limitations of Hospital

To assess the association

Observational

948,093 CABG procedures

Medicare CABG

Risk-adjusted mortality

Considerable mortality heterogeneity at all volume

Volume as a Measure of

between CABG volume

 

 

Patients/1996 to 2001/870 US

 

levels.

Quality of Care for CABG.

and outcomes

 

 

hospitals.

 

 

2005 (213)

 

 

 

 

 

Volume alone a poor predictor of mortality (c-

 

 

 

 

 

 

index=0.52), similar to “coin toss.”

 

 

 

 

 

 

253 of 660 hospitals (38%) with volume <450 cases

 

 

 

 

 

 

annually had risk-adjusted mortality rates similar to or

 

 

 

 

 

 

lower than the overall risk-adjusted mortality of high-

 

 

 

 

 

 

volume hospitals (5.2%).

 

 

 

 

 

 

 

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

 

 

 

 

Association of hospital

To examine the

Observational

144,526 isolated CABG

Isolated CABG

Risk-adjusted mortality,

Unadjusted mortality decreased across volume

coronary artery bypass

association of CABG

 

patients

patients/2007/733 hospitals

morbidity, NQF process

categories (2.6% for <100 cases, 1.7% for >450 cases;

volume with processes of

volume and mortality,

 

 

participating in the STS-NCD.

measure adherence.

p<0.0001).

care, mortality, morbidity,

morbidity, processes of

 

 

 

 

 

and the STS Surgeons

care, and STS CABG

 

 

 

 

After multivariable adjustment, mortality OR: 1.49

composite quality score.

composite score.

 

 

 

 

(lowest vs. highest volume).

2010 (214)

 

 

 

 

 

 

 

 

 

 

 

 

Most care processes and morbidity not associated with

 

 

 

 

 

 

volume.

 

 

 

 

 

 

Lowest volume group (<100 cases) had lowest

 

 

 

 

 

 

composite scores but volume only explained 1% of

 

 

 

 

 

 

latter.

 

 

 

 

 

 

Considerable performance heterogeneity at low

 

 

 

 

 

 

volumes, and low volume did not preclude excellent

 

 

 

 

 

 

performance.

 

 

 

 

 

 

 

Volume and outcome of

To assess changes in the

Systematic

 

16 CABG volume-outcome

 

Progressive increase of OR favoring high volume

CABG: are more and less

CABG volume-outcome

review

 

studies (1980 to 2002).

 

hospitals from 0.55 in 1972 to 0.95±0.07.

the same? 2004 (215)

association over time.

 

 

 

 

 

 

 

 

 

High and low volume cohorts

 

All OR estimates per 100 patients close to 1.0,

 

 

 

 

(200 case cut-point).

 

suggesting minimal effect of volume on mortality.

 

 

 

 

 

 

 

The role of hospital volume

To determine if low risk

Observational

2,029 CABG patients at 25

1997 administrative and

In-hospital mortality,

Significant differences in in-hospital mortality between

in coronary artery bypass

patients have improved

study

low-volume hospitals.

clinical data from Solucient

costs and LOS

lowand high-volume facilities in moderate (5.3% vs.

grafting: is more always

outcomes at high volume

 

 

EXPLORE.

 

2.2%; p=0.007) and high risk (22.6% vs. 11.9%;

better? 2001 (216)

hospitals.

 

11,615 CABG patients at 31

 

 

p=0.0026) but not minimal, lowor severe-risk

 

 

 

high-volume (≥200 annual

Patients classified into 5

 

patients.

 

 

 

cases) hospitals.

surgical risk groups: minimal

 

 

 

 

 

 

(<0.5%), low (0.5% to 2%),

 

Hospital costs and LOS similar across risk groups.

 

 

 

 

moderate (2% to 5%), high

 

 

 

 

 

 

(5% to 20%), and severe

 

Targeted regionalization for moderate to higher risk

 

 

 

 

(≥20%).

 

patients feasible.

Procedural volume as a

To determine the

Observational

267,089 isolated CABG

January 1, 2000 to December

Adjusted operative

Adjusted rates of operative mortality decreased with

marker of quality for CABG.

association between

 

procedures

31, 2001/439 US hospitals

mortality

increasing hospital CABG volume (0.07% for every

2004 (217)

CABG volume and

 

 

participating in the STS-NCD.

 

100 additional CABG procedures; adjusted OR: 0.98;

 

outcomes in a large

 

 

 

 

95% CI: 0.96 to 0.99; p=0.004).

 

clinical data registry.

 

 

 

 

 

 

 

 

 

 

 

Volume-mortality not observed in patients <65 y or in

 

 

 

 

 

 

those at low operative risk.

 

 

 

 

 

 

 

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

 

 

 

 

Limited ability of hospital volume to discriminate performance due to the wide variability in risk-adjusted mortality among hospitals with similar volume.

“…hospital procedural volume is only modestly associated with CABG outcomes and therefore may not be an adequate quality metric for CABG surgery.”

ANOVA indicates analysis of variance; CABG, coronary artery bypass graft; CA, California; HR, hazard ratio; LOS, length of stay; NQF, National Quality Forum; NY, New York; OR, odds ratio; STS, Society of Thoracic Surgeons; STS-NCD, Society of Thoracic Surgeons-National Cardiac Database; US, United States; VA, Veterans Affairs; and y, year.

Data Supplement 33. Use of Epiaortic Ultrasound Imaging to Reduce Stroke Rates

Study

Sample Characteristics

Sample Size

Stroke Rate:

Stroke Rate:

 

P-Value

Interval Between

 

 

 

On-Pump

Off-Pump

 

 

Surgery and Outcome

ROOBY 2009 (218)

All male

2203

0.7%

1.3%

p=0.28 (NS)

 

30 d

 

 

 

 

 

 

 

 

Nathoe et al. 2003 (Octopus) (219)

Low-risk patients

281

1.4%

0.7%

p=0.55 (NS)

 

1 y

 

 

 

 

 

 

 

 

SMART 2004 (220)

Single surgeon

197

2.0%

1.0%

(NS)

 

30 d

 

 

 

 

 

 

 

 

Best Bypass Surgery trial 2010 (221)

High-risk patients

341

3.7%

4.0%

p=1.00 (NS)

 

>30 d

 

 

 

 

 

 

 

 

BHACAS 1 / 2 2002 (222)

Single institution

401

3%/ 3%

2%/ 1%

(NS)

 

>30 d

 

 

 

 

 

 

 

 

Legare 2004 (223)

Single-center trial

300

0.0%

1.3%

p=0.50 (NS)

 

In-hospital

 

 

 

 

 

 

 

 

Muneretto 2003 (224)

Low-risk

176

2.2%

0.0%

(NS)

 

“early” outcome

 

 

 

 

 

 

 

 

BHACAS indicates Beating heart against cardioplegic arrest studies; d, day; NS, non-significant; Rooby, Randomized On/Off Trial; SMART, Surgical Management of Arterial Revascularization Therapies and y, year.

Data Supplement 34. Randomized Trials Comparing Cognitive Outcomes After On-Pump And Off-Pump Surgery: Postoperative Cognitive Impairment

 

Study

 

 

Year

 

 

Sample

 

 

Sample

 

 

Follow-Ip

 

 

Incidence of Decline

P-Value/Comments

 

 

 

 

Published

 

 

Characteristics

 

 

Size

 

 

Interval

 

 

On-Pump/Off-pump

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Van Dijk D et al.

 

2002

 

 

Low risk

 

281

 

 

3 mo

 

29%

 

21%

NS

 

(Octopus Trial)

 

 

 

 

 

Patients

 

 

 

 

 

12 mo

 

34%

 

31%

NS

(225, 226)

 

2007

 

 

 

 

 

 

 

 

5 y

 

35%

 

33%

NS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

St. Francis

2003

Single center

60

2 wk

15%

16%

NS

Medical Center

 

 

 

12 mo

15%

19%

NS

(227)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Lund (228)

2005

Single center

120

3 mo

23%

20%

NS

 

 

 

 

12 mo

23%

24%

NS

 

 

 

 

 

 

 

 

Jenson (substudy of

2006

High-risk

120

3 mon

24%

20%

NS

Best Bypass Surgery

 

patients

 

 

 

 

 

trial) (229, 230)

2008

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1 y

19%

9%

NS

Ernest (231)

2006

Single institution

107

2 mo

N/A

N/A

No difference in incidence of cognitive impairment

 

 

 

 

6 mo

N/A

N/A

Lower incidence of cognitive impairment in off-pump

 

 

 

 

 

 

 

group for 1 test (word fluency)

 

 

 

 

 

 

 

 

Al-Ruzzeh (232)

 

Single institution

168

6 wk

N/A

N/A

Off-pump performed significantly better in 3/15 tests

 

 

 

 

 

 

 

(p≤0.001)

 

 

 

 

6 mo

N/A

N/A

Off-pump group performed significantly better in 2/15

 

 

 

 

 

 

 

tests (p<0.001)

 

 

 

 

 

 

 

 

Vedin (233)

2006

Single institution

70

1 wk

57%

58%

NS

 

 

 

 

1 mo

30%

12%

NS

 

 

 

 

6 mo

19%

15%

NS

 

 

 

 

 

 

 

 

Motallebzadeh (234)

2007

Single institution

212

Discharge

N/A

N/A

Higher global composite cognitive score (0.25 standard

 

 

 

 

 

 

 

deviation) in the off-pump group (p=0.01)

 

 

 

 

6 mo

N/A

N/A

No SD in global composite score between on-pump and

 

 

 

 

 

 

 

off-pump groups

 

 

 

 

6 mo

N/A

N/A

No SD in global composite score between on-pump and

 

 

 

 

 

 

 

off-pump groups

 

 

 

 

 

 

 

 

Hernandez (235)

2007

Single institution

201

Discharge

62%

52%

NS

 

 

 

 

6 mo

47%

44%

NS

 

 

 

 

 

 

 

 

ROOBY (218)

2009

VA Medical

2203

1 y

N/A

N/A

No difference between onand off-pump in change in

 

 

Centers

 

 

 

 

global z-score from baseline to follow-up

Mo indicates month; N/A, not applicable; NS, not significant; Rooby indicates Randomized On/Off Trial; SD, significant difference; VA, Veteran Affairs; wk, week and y, year.

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

Data Supplement 35. Mediastinitis and Perioperative Infection

Study Name

Aim of Study

Study

Study Size

Patient Population/Inclusion &

Endpoints

Statistical Analysis

P Values

OR / HR

Study Summary

 

 

Type

 

Exclusion Criteria

 

 

Reported

& 95% CI

/ RR

 

 

 

 

 

Inclusion

Exclusion

Primary

Secondary

 

 

 

 

 

 

 

 

Criteria

Criteria

Endpoint

Endpoint

 

 

 

 

Impact of

To examine

Part of the

23,499

All patients

Patients

DSWI rate

Early hospital

VAC therapy (n=125)

p=0.01

N/A

DSWI remains a major and

DSWI

the outcome of

data was

total

undergoing

undergoing

 

mortality,

was associated with a

(mortality),

 

challenging complication of OHS.

management

patients with

collected

number of

open heart

thoracic aortic

 

hospital stay,

lower mortality (4.8% vs.

p=0.02 (1-,

 

VAC therapy with sternal

with VAC

DSWI now

retrospectiv

patients

surgery

surgery or heart

 

DSWI

14.1%, p=0.01). Early

2- and 3-

 

preservation followed by delayed

therapy

treated with

ely, and

(267

 

transplantation

 

recurrence, 1-

adjusted survival for

survival)

 

sternal osteosynthesis and

followed by

VAC therapy

part -

patients

 

as well as

 

, 2- and 3-y

patients with DSWI

 

 

pectoralis myocutaneous flaps has

sternal

as a bridge to

prospective

with

 

congenital cases

 

survival

treated with VAC therapy

 

 

been recently proposed as a new

osteosynthesis:

sternal

ly

DSWI)

 

were all

 

 

was 92.8%, 89.8% and

 

 

therapeutic strategy. Most

a 15-y review

osteosynthesis

 

 

 

excluded from

 

 

88.0%, respectively, at 1-

 

 

patients treated with VAC therapy

of 23,499

with horizontal

 

 

 

the present study

 

 

, 2- and 3-y, compared

 

 

showed decreased perioperative

sternotomies.

titanium plate

 

 

 

 

 

 

with 83.0%, 76.4% and

 

 

mortality and increased survival.

2010 (236)

fixation

 

 

 

 

 

 

61.3%, respectively, for

 

 

 

 

 

 

 

 

 

 

 

patients with DSWI

 

 

 

 

 

 

 

 

 

 

 

treated without VAC

 

 

 

 

 

 

 

 

 

 

 

(p=0.02).

 

 

 

VAC of DSWI

To examine

Prospective

22

All cardiac

N/A

Reduction of

Need for

VAC induced granulation

p<0.05

N/A

Adjunctive VAC therapy

in high-risk

the effect of

 

 

surgery

 

wound size

secondary

of 71% of the sternal

(reduction

 

markedly reduced required

patients after

VAC on

 

 

patients who

 

 

surgical

wound area by 7 d. By 14

of wound

 

surgical interventions, reoperation

cardiac surgery.

sternal wounds

 

 

developed

 

 

intervention,

d, there was a 54%

size)

 

for persistent infections, and the

2005 (237)

 

 

 

DSWI

 

 

LOS, VAC

reduction in wound size,

 

 

hospitalization period. VAC

 

 

 

 

 

 

 

complications

and patients were

 

 

provides a viable and efficacious

 

 

 

 

 

 

 

 

discharged after

 

 

adjunctive method by which to

 

 

 

 

 

 

 

 

approximately 19.5 d and

 

 

treat postoperative wound

 

 

 

 

 

 

 

 

placed on home therapy.

 

 

infection after medial sternotomy.

 

 

 

 

 

 

 

 

VAC was discontinued at

 

 

 

 

 

 

 

 

 

 

 

approximately 36.7 d

 

 

 

 

 

 

 

 

 

 

 

with an average reduction

 

 

 

 

 

 

 

 

 

 

 

in sternal wound size of

 

 

 

 

 

 

 

 

 

 

 

80%. Extensive

 

 

 

 

 

 

 

 

 

 

 

secondary surgical

 

 

 

 

 

 

 

 

 

 

 

closure, requiring muscle

 

 

 

 

 

 

 

 

 

 

 

flaps, was avoided in

 

 

 

 

 

 

 

 

 

 

 

64% of patients, whereas

 

 

 

 

 

 

 

 

 

 

 

28% of patients required

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

no surgical reconstruction

 

 

 

 

 

 

 

 

 

 

 

for wound closure.

 

 

 

The VAC

To report an

Prospective

11

Patients with

N/A

Length of

In-hospital

Median ICU stay of

N/A

N/A

In-hospital mortality was 0%, and

system for the

experience

 

 

DSWI after

 

ICU and

mortality, 30-

patients treated with

 

 

30-d survival was 100%. Median

treatment of

with the VAC

 

 

cardiac surgery

 

hospital stay

d survival,

pectoralis muscle flap

 

 

hospital stay ranged from 13 to 45

DSWI after

system (KCI

 

 

 

 

 

complication

closure without

 

 

d (median 30 d). Most

cardiac surgery.

Inc., San

 

 

 

 

 

rate

pretreatment with the

 

 

importantly, there were no VAC

2002 (238)

Antonio, TX)

 

 

 

 

 

 

VAC system was 9.5 d

 

 

device–related complications.

 

as an adjunct

 

 

 

 

 

 

(range 4 to 26 d),

 

 

 

 

in the

 

 

 

 

 

 

whereas patients with

 

 

 

 

treatment of

 

 

 

 

 

 

VAC treatment had an

 

 

 

 

DSWI after

 

 

 

 

 

 

ICU stay of median 1 d

 

 

 

 

cardiac

 

 

 

 

 

 

(range 1 to 4 d).

 

 

 

 

surgery

 

 

 

 

 

 

 

 

 

 

VAC as a

To assess the

Prospective

27

Patients who

N/A

Mortality

Healed scar

VAC-group mortality

N/A

N/A

VAC, used alone or before other

treatment

impact of

 

 

underwent

 

 

(%), duration

was 28.6% vs. 7.7% in

 

 

surgical treatment strategies, is an

modality for

VAC on the

 

 

cardiac surgery

 

 

of VAC,

VAC+ second procedure

 

 

acceptable treatment modality for

infections after

management

 

 

through a

 

 

LOS, cost of

group. A satisfactorily

 

 

infections in cardiac surgery with

cardiac surgery.

of sternal

 

 

median

 

 

treatment

healed scar was achieved

 

 

reasonable morbidity, mortality,

2003 (239)

wound

 

 

sternotomy and

 

 

 

in 64% of VAC-cases

 

 

and cost.

 

infections in

 

 

acquired

 

 

 

and in 77% of VAC+

 

 

 

 

terms of

 

 

sternal wound

 

 

 

second procedure cases.

 

 

 

 

wound

 

 

infections

 

 

 

Median durations of

 

 

 

 

healing,

 

 

 

 

 

 

VAC in VAC-group were

 

 

 

 

duration of

 

 

 

 

 

 

13.5 d (interquartile

 

 

 

 

VAC, and cost

 

 

 

 

 

 

range 8.8 to 32.2 d), and

 

 

 

 

of treatment

 

 

 

 

 

 

median hospital stay was

 

 

 

 

 

 

 

 

 

 

 

20 d (interquartile range

 

 

 

 

 

 

 

 

 

 

 

16.7 to 25.2 d). Median

 

 

 

 

 

 

 

 

 

 

 

duration of vacuum-

 

 

 

 

 

 

 

 

 

 

 

assisted closure in VAC+

 

 

 

 

 

 

 

 

 

 

 

second procedure group

 

 

 

 

 

 

 

 

 

 

 

was 8 d (interquartile

 

 

 

 

 

 

 

 

 

 

 

range 5.5 to 18 d), and

 

 

 

 

 

 

 

 

 

 

 

median hospital stay was

 

 

 

 

 

 

 

 

 

 

 

29 d (interquartile range

 

 

 

 

 

 

 

 

 

 

 

25.8 to 38.2 d). The total

 

 

 

 

 

 

 

 

 

 

 

cost (hospitalization and

 

 

 

 

 

 

 

 

 

 

 

treatment) per patient for

 

 

 

 

 

 

 

 

 

 

 

VAC was $16,400,

 

 

 

 

 

 

 

 

 

 

 

compared with $20,000

 

 

 

 

 

 

 

 

 

 

 

for the closed irrigation

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

system treatment.

 

 

 

The concept of

To report an

Prospective

3,668 total

Patients with

N/A

DSI rate

LOS, time

The detection of DSI and

N/A

N/A

In line with the mentioned articles

NPWT after

experience of

 

number of

DSI after

 

 

from

subsequent treatment

 

 

and reviews we come to the

poststernotomy

using NPWT

 

patients/54

cardiac surgery

 

 

operation to

with NPWT of the

 

 

conclusion, that negative pressure

mediastinitis--a

followed by

 

patients

procedures.

 

 

detection of

patients is clearly

 

 

wound treatment is a relatively

single center

muscular

 

with DSI

 

 

 

mediastinitis,

prolonged: the period of

 

 

new option for treatment of

experience with

pectoralis

 

 

 

 

 

time from the

time that patients stayed

 

 

devastating wounds after

54 patients.

plasty in

 

 

 

 

 

start of the

in hospital ranged from

 

 

sternotomy in cardiac surgery. As

2009 (240)

treatment of

 

 

 

 

 

NPWT

22 d up to 185 d (median

 

 

many institutions have presented

 

DSIs after

 

 

 

 

 

therapy until

64.5 d). The time period

 

 

their own approaches, it is

 

cardiac

 

 

 

 

 

date of

from the date of

 

 

important to find a strategy which

 

surgery

 

 

 

 

 

discharge,

operation until detection

 

 

may be used as a "standard

 

procedures

 

 

 

 

 

complication

of mediastinitis ranged

 

 

NPWT approach" if identified in

 

 

 

 

 

 

 

rate

from 5 d to 155 d (19 d).

 

 

the future.

 

 

 

 

 

 

 

 

Time period from the

 

 

 

 

 

 

 

 

 

 

 

start of the NPWT

 

 

 

 

 

 

 

 

 

 

 

therapy until date of

 

 

 

 

 

 

 

 

 

 

 

discharge from hospital

 

 

 

 

 

 

 

 

 

 

 

ranged from 7 d until 99

 

 

 

 

 

 

 

 

 

 

 

d with a median at 35 d.

 

 

 

 

 

 

 

 

 

 

 

No complications were

 

 

 

 

 

 

 

 

 

 

 

found in 74% of patients.

 

 

 

Management of

To report on

Retrospecti

409

Patients who

N/A

Mortality/mor

N/A

Mean hospital stay after

(p=0.005)

N/A

With aggressive early debridment

the infected

morbidity and

ve

 

developed

 

bidity

 

sternal wound

 

 

and flap the mortality and

median

mortality in

 

 

DSWI after

 

 

 

reconstruction declined

 

 

hospital stay after DSWI has

sternotomy

patients treated

 

 

cardiac surgery

 

 

 

from 18.6 d (1988 to

 

 

decreased over time

wound with

for DSWI with

 

 

 

 

 

 

1992) to 12.4 d (1993 to

 

 

 

muscle flaps.

sternal

 

 

 

 

 

 

1996)

 

 

 

The Emory 20-

debridment

 

 

 

 

 

 

 

 

 

 

y experience.

and flap

 

 

 

 

 

 

 

 

 

 

1997 (241)

 

 

 

 

 

 

 

 

 

 

 

Prospective trial

To determine

Prospective

43

Patients with

N/A

Wound

LOS, rate of

N/A

N/A

N/A

Irritation alone failed in 88% of

of catheter

the appropriate

 

 

sternal

 

resolution

complications

 

 

 

patients with DSWI. All patients

irrigation and

roles of

 

 

dehiscence or

 

 

 

 

 

 

treated with flap had a successful

muscle flaps for

closed-chest

 

 

infection

 

 

 

 

 

 

outcome.

sternal wound

catheter

 

 

 

 

 

 

 

 

 

 

infection. 1998

irrigation and

 

 

 

 

 

 

 

 

 

 

(242)

muscle flap

 

 

 

 

 

 

 

 

 

 

 

closure for

 

 

 

 

 

 

 

 

 

 

 

sternotomy

 

 

 

 

 

 

 

 

 

 

 

infection

 

 

 

 

 

 

 

 

 

 

Two-stage

To report on

Retrospecti

68

Patients with

N/A

Mortality/mor

N/A

91% survival at 1 y and

N/A

 

N/A

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

management of

morbidity and

ve

 

DSWI after

 

bidity

 

0% mortality for patients

 

 

 

sternal wound

mortality in

 

 

cardiac surgery

 

 

 

treated with flap after

 

 

 

infection using

patients treated

 

 

 

 

 

 

DSWI .

 

 

 

bilateral

for DSWI with

 

 

 

 

 

 

 

 

 

 

pectoralis major

sternal

 

 

 

 

 

 

 

 

 

 

advancement

debridment

 

 

 

 

 

 

 

 

 

 

flap. 2006 (243)

and flap

 

 

 

 

 

 

 

 

 

 

CI, indicates confidence interval; d, day; DSI, deep sternal infection; DSWI, deep sternal wound infection; HR, hazard ratio; ICU, intensive care unit; LOS, length of stay; N/A, not applicable; NPWT, negative pressure wound therapy; OHS, open heart surgery; OR, odds ratio; RR, relative risk; and VAC, vacuum-assisted closure.

Data Supplement 36. Mediastinitis and Perioperative Infection

Study Name

Aim of Study

Study

Study

Patient Population/Inclusion &

Endpoints

Statistical

P-Values

OR / HR / RR

Study Summary

 

 

Type

Size

Exclusion Criteria

 

 

Analysis

& 95%

(95% CI)

 

 

 

 

 

 

 

 

 

Reported

CI

 

 

 

 

 

 

Inclusion

Exclusion

Primary

Secondary

 

 

 

 

 

 

 

 

Criteria

Criteria

Endpoint

Endpoint

 

 

 

 

Glycopeptides

To

Meta-

5,761

Trials that

N/A

Occurrence of

Chest SSI,

N/A

N/A

SSI RR: 1.14; (95% CI: 0.91 to

Neither agent proved to be

are no more

investigate

analysis

 

compared SSI in

 

SSI at 30 d

Deep-chest

 

 

1.42)

superior for prevention of

effective than

whether a

 

 

subjects receiving

 

 

SSI, Leg SSI,

 

 

Chest SSI RR: 1.47; (95% CI:

the primary outcome,

beta-lactam

switch from

 

 

glycopeptide

 

 

SSI due to

 

 

1.11 to 1.95)

occurrence of SSI at 30 d. In

agents for

beta-lactams

 

 

prophylaxis with

 

 

different

 

 

Deep-chest SSI RR: 1.33; (95%

subanalyses, beta-lactams

prevention of

to

 

 

SSI in those who

 

 

microorganis

 

 

CI: 0.91 to 1.94)

were superior to

SSI after

glycopeptides

 

 

received beta-

 

 

ms

 

 

Leg SSI RR: 0.77; (95% CI:

glycopeptides for prevention

cardiac surgery:

for cardiac

 

 

lactam

 

 

 

 

 

0.58 to 1.01)

of chest SSI and approached

a meta-analysis.

surgery

 

 

prophylaxis were

 

 

 

 

 

SSI due to gram positive

superiority for prevention of

2004 (244)

prophylaxis

 

 

pooled

 

 

 

 

 

bacteria RR: 1.36; (95% CI:

deep-chest SSI and SSI

 

should be

 

 

 

 

 

 

 

 

0.98 to 1.91)

caused by gram-positive

 

advised.

 

 

 

 

 

 

 

 

SSI due to meticillin-resistant

bacteria. Glycopeptides

 

 

 

 

 

 

 

 

 

 

gram-positive bacteria RR: 0.54;

approached superiority to

 

 

 

 

 

 

 

 

 

 

(95% CI: 0.33 to 0.90)

beta-lactams for prevention

 

 

 

 

 

 

 

 

 

 

SSI due to other organism RR:

of leg SSI and were superior

 

 

 

 

 

 

 

 

 

 

1.08; (95% CI: 0.75 to 1.55)

for prevention of SSI caused

 

 

 

 

 

 

 

 

 

 

 

by methicillin-resistant

 

 

 

 

 

 

 

 

 

 

 

gram-positive bacteria.

 

 

 

 

 

 

 

 

 

 

 

Standard prophylaxis for

 

 

 

 

 

 

 

 

 

 

 

cardiac surgery should

 

 

 

 

 

 

 

 

 

 

 

continue to be beta-lactams

 

 

 

 

 

 

 

 

 

 

 

in most circumstances.

Vancomycin

This study

RCT

885

All adult patients

Exclusion

SSI rates

Duration of

The overall SSI

p=0.8

N/A

The durations of

versus cefazolin

was

 

 

(≥18 y) scheduled

criteria

 

postoperative

rates were

(overall

 

postoperative hospitalization

prophylaxis for

undertaken to

 

 

for cardiac

included the

 

hospitalizatio

similar in the 2

SSI)

 

and the mortalities were

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