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monotonically from 7.25% to 2.85%. |
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Crude mortality rates decrease monotonically from |
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9.09% for annual surgeon volumes between 1 to 54 to |
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2.89% for annual surgeon volumes ≥260. |
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Risk-adjusted rates decrease from 8.14% for patients of |
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surgeons with volumes <55 to 2.43% for patients of |
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surgeons with volumes ≥260. |
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Best results (risk-adjusted mortality 2.18%) in hospitals |
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performing ≥890 cardiac operations in 1989 and from |
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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 |
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patients |
hospitals |
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surgeon volume categories. |
The role of surgeon volume. |
between surgeon volume |
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1995 (206) |
and in-hospital mortality |
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Low-volume surgeons (≤50 CABG/y) had largest |
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for CABG in NY. |
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reduction (60%) in risk-adjusted mortality over 4-y. |
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To explain changes in |
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Highest-volume surgeons (>150 CABG/y) had 34% |
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mortality over time. |
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reduction. |
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Percentage of patients having CABG by low-volume |
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surgeons decreased from 7.6% in 1989 to 5.7% in 1992 |
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(25% reduction). |
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Part of decrease due to exodus of low-volume surgeons |
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with high risk-adjusted mortality; better performance |
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of surgeons who were new to the system; and |
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performance of surgeons who were not consistently |
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low-volume surgeons. |
Volume and outcome in |
To assess impact of |
Systematic |
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1972 to 1992 |
CABG mortality |
All 7 studies reported reduced mortality with increased |
CABG: true association or |
case-mix on CABG |
review |
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volume. |
artifact? 1995 (207) |
volume-outcome studies |
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7 studies of CABG volume- |
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outcome association |
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Studies with better case-mix adjustment indicated less |
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reduction in mortality with increased volume (p=0.04). |
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US data |
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Apparent advantages of higher volume decreased over |
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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 |
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patients |
1999 |
mortality |
observed above all annual hospital volume thresholds |
still have lower risk-adjusted |
association with |
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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. |
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Cardiac Surgery Reporting |
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thresholds between 50 to 200. |
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System |
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Risk-adjusted mortality rate for surgeons with volumes |
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of ≥125 in hospitals with volumes of ≥600 was 1.89%. |
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Risk-adjusted mortality significantly higher (2.67%) |
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for surgeons with volumes of <125 in hospitals with |
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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 |
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patients |
Surgery Reporting |
mortality |
and 600 cases, adjusted ORs of mortality for high- |
hospital mortality rate for |
only valid for high-risk |
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System)/1997 to 1999. |
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volume to low-volume hospitals =0.45 to 0.77 (all |
CABG limited to patients at |
patients. |
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significant) for low-risk group. |
high risk? 2004 (209) |
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For moderateto high-risk group, OR: 0.62 to 0.91 |
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(most significant). |
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As annual surgeon volume threshold increased from 50 |
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to 150 cases, ORs for highto low-volume surgeons |
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increased from 0.43 to 0.74 for low-risk group. |
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For the moderateto high-risk group, ORs ranged from |
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0.79 to 0.86. Compared with patients treated by |
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surgeons with volumes of <125 in hospitals with |
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volumes of <600, patients treated by higher-volume |
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surgeons in higher-volume hospitals had significantly |
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lower risk of death (OR: 0.52 for low-risk group). |
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Higher volume associated with better outcomes for all |
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risk groups. |
Outcome as a function of |
To determine association |
Observational |
124,793 CABG patients |
Isolated CABG patients/1991 |
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Variability of outcome was significant in lower volume |
annual CABG volume. 1996 |
between risk-adjusted |
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to 1993/>600 US hospitals. |
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practices (<600 cases/y) and varied little at >600 |
(210) |
CABG mortality and |
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cases/y. |
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volume. |
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STS-NCD |
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No practice volume category had an observed/expected |
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1,200 surgeons |
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ratio of less than 0.8 or >1.2 if annual volume was |
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>100. |
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Practices of <100 cases/y had an observed/expected |
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ratio of 1.6. |
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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 |
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September 1992/44 VA |
mortality |
volume and risk-adjusted operative mortality (p=0.10). |
hospital coronary artery |
and outcome in VA |
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hospitals. |
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© American College of Cardiology Foundation and American Heart Association, Inc.
bypass grafting surgical |
hospitals. |
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Using ANOVA, hospitals with ≤100 cases per y have |
volume and operative |
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higher observed to expected mortality ratios than |
mortality. 1996 (211) |
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hospitals performing >100 cases per y (p=0.03). |
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Using Poisson regression models, volume threshold not |
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found. |
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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 |
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Inpatient Sample |
hospital CABG volume |
hospitals, 3.74% in medium-volume hospitals, and |
2000. 2004 (212) |
CABG |
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group (low=12 to 249 |
3.54% in high-volume hospitals (trend p<0.001). |
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cases/y, medium=250 to |
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499 cases/y, high ≥500 |
Compared with high-volume hospitals, patients at low- |
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cases/y) |
volume hospitals had increased adjusted mortality risk |
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(OR: 1.26; 95% CI: 1.15 to 1.39), as did medium |
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volume hospitals (OR: 1.11; 95% CI: 1.01 to 1.21). |
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Considerable outcomes heterogeneity at every volume |
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level. |
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207 of 243 (85%) low-volume and 151 of 169 (89%) |
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medium-volume hospital-y had risk-standardized |
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mortality rates that were statistically lower or |
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comparable to expected. |
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Only 11 of 169 (6%) high-volume hospital-y had |
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outcomes that were statistically better than expected |
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and 18 of 161 (11%) high-volume hospital-y had worse |
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than expected risk-standardized mortality rates. |
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“Volume is not a reliable marker of hospital CABG |
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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 |
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Patients/1996 to 2001/870 US |
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levels. |
Quality of Care for CABG. |
and outcomes |
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hospitals. |
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2005 (213) |
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Volume alone a poor predictor of mortality (c- |
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index=0.52), similar to “coin toss.” |
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253 of 660 hospitals (38%) with volume <450 cases |
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annually had risk-adjusted mortality rates similar to or |
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lower than the overall risk-adjusted mortality of high- |
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volume hospitals (5.2%). |
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© American College of Cardiology Foundation and American Heart Association, Inc. |
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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 |
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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, |
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participating in the STS-NCD. |
measure adherence. |
p<0.0001). |
care, mortality, morbidity, |
morbidity, processes of |
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and the STS Surgeons |
care, and STS CABG |
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After multivariable adjustment, mortality OR: 1.49 |
composite quality score. |
composite score. |
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(lowest vs. highest volume). |
2010 (214) |
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Most care processes and morbidity not associated with |
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volume. |
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Lowest volume group (<100 cases) had lowest |
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composite scores but volume only explained 1% of |
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latter. |
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Considerable performance heterogeneity at low |
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volumes, and low volume did not preclude excellent |
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performance. |
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Volume and outcome of |
To assess changes in the |
Systematic |
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16 CABG volume-outcome |
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Progressive increase of OR favoring high volume |
CABG: are more and less |
CABG volume-outcome |
review |
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studies (1980 to 2002). |
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hospitals from 0.55 in 1972 to 0.95±0.07. |
the same? 2004 (215) |
association over time. |
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High and low volume cohorts |
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All OR estimates per 100 patients close to 1.0, |
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(200 case cut-point). |
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suggesting minimal effect of volume on mortality. |
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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 |
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EXPLORE. |
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2.2%; p=0.007) and high risk (22.6% vs. 11.9%; |
better? 2001 (216) |
hospitals. |
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11,615 CABG patients at 31 |
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p=0.0026) but not minimal, lowor severe-risk |
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high-volume (≥200 annual |
Patients classified into 5 |
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patients. |
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cases) hospitals. |
surgical risk groups: minimal |
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(<0.5%), low (0.5% to 2%), |
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Hospital costs and LOS similar across risk groups. |
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moderate (2% to 5%), high |
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(5% to 20%), and severe |
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Targeted regionalization for moderate to higher risk |
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(≥20%). |
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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 |
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procedures |
31, 2001/439 US hospitals |
mortality |
increasing hospital CABG volume (0.07% for every |
2004 (217) |
CABG volume and |
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participating in the STS-NCD. |
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100 additional CABG procedures; adjusted OR: 0.98; |
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outcomes in a large |
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95% CI: 0.96 to 0.99; p=0.004). |
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clinical data registry. |
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Volume-mortality not observed in patients <65 y or in |
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those at low operative risk. |
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© American College of Cardiology Foundation and American Heart Association, Inc. |
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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: |
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P-Value |
Interval Between |
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On-Pump |
Off-Pump |
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Surgery and Outcome |
ROOBY 2009 (218) |
All male |
2203 |
0.7% |
1.3% |
p=0.28 (NS) |
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30 d |
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Nathoe et al. 2003 (Octopus) (219) |
Low-risk patients |
281 |
1.4% |
0.7% |
p=0.55 (NS) |
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1 y |
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SMART 2004 (220) |
Single surgeon |
197 |
2.0% |
1.0% |
(NS) |
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30 d |
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Best Bypass Surgery trial 2010 (221) |
High-risk patients |
341 |
3.7% |
4.0% |
p=1.00 (NS) |
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>30 d |
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BHACAS 1 / 2 2002 (222) |
Single institution |
401 |
3%/ 3% |
2%/ 1% |
(NS) |
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>30 d |
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Legare 2004 (223) |
Single-center trial |
300 |
0.0% |
1.3% |
p=0.50 (NS) |
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In-hospital |
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Muneretto 2003 (224) |
Low-risk |
176 |
2.2% |
0.0% |
(NS) |
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“early” outcome |
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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
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Study |
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Year |
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Sample |
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Sample |
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Follow-Ip |
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Incidence of Decline |
P-Value/Comments |
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Published |
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Characteristics |
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Size |
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Interval |
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On-Pump/Off-pump |
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Van Dijk D et al. |
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2002 |
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Low risk |
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281 |
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3 mo |
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29% |
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21% |
NS |
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(Octopus Trial) |
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Patients |
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12 mo |
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34% |
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31% |
NS |
(225, 226) |
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2007 |
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5 y |
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35% |
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33% |
NS |
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© American College of Cardiology Foundation and American Heart Association, Inc.
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St. Francis |
2003 |
Single center |
60 |
2 wk |
15% |
16% |
NS |
Medical Center |
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12 mo |
15% |
19% |
NS |
(227) |
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Lund (228) |
2005 |
Single center |
120 |
3 mo |
23% |
20% |
NS |
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12 mo |
23% |
24% |
NS |
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Jenson (substudy of |
2006 |
High-risk |
120 |
3 mon |
24% |
20% |
NS |
Best Bypass Surgery |
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patients |
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trial) (229, 230) |
2008 |
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1 y |
19% |
9% |
NS |
Ernest (231) |
2006 |
Single institution |
107 |
2 mo |
N/A |
N/A |
No difference in incidence of cognitive impairment |
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6 mo |
N/A |
N/A |
Lower incidence of cognitive impairment in off-pump |
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group for 1 test (word fluency) |
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Al-Ruzzeh (232) |
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Single institution |
168 |
6 wk |
N/A |
N/A |
Off-pump performed significantly better in 3/15 tests |
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(p≤0.001) |
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6 mo |
N/A |
N/A |
Off-pump group performed significantly better in 2/15 |
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tests (p<0.001) |
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Vedin (233) |
2006 |
Single institution |
70 |
1 wk |
57% |
58% |
NS |
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1 mo |
30% |
12% |
NS |
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6 mo |
19% |
15% |
NS |
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Motallebzadeh (234) |
2007 |
Single institution |
212 |
Discharge |
N/A |
N/A |
Higher global composite cognitive score (0.25 standard |
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deviation) in the off-pump group (p=0.01) |
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6 mo |
N/A |
N/A |
No SD in global composite score between on-pump and |
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off-pump groups |
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6 mo |
N/A |
N/A |
No SD in global composite score between on-pump and |
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off-pump groups |
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Hernandez (235) |
2007 |
Single institution |
201 |
Discharge |
62% |
52% |
NS |
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6 mo |
47% |
44% |
NS |
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ROOBY (218) |
2009 |
VA Medical |
2203 |
1 y |
N/A |
N/A |
No difference between onand off-pump in change in |
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Centers |
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|
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.