Download Vacuum-assisted closure of post-sternotomy mediastinitis as

INSTITUTIONAL REPORT
Interactive CardioVascular and Thoracic Surgery 14 (2012) 17–21
doi:10.1093/icvts/ivr049 Advance Access publication 16 November 2011
Vacuum-assisted closure of post-sternotomy mediastinitis
as compared to open packing
Roemer J. Vosa, Alaaddin Yilmaza, Uday Sonkera, Johannes C. Kelderb and Geoffrey T.L. Kloppenburga,*
a
b
Department of Cardiothoracic Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands
Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands
*Corresponding author. Tel: +31-30-6092104; fax: +31-30-6092120; e-mail: [email protected] (G. Kloppenburg).
Received 28 June 2011; received in revised form 12 September 2011; accepted 27 September 2011
Post-sternotomy mediastinitis is a rare but serious complication of cardiac surgery leading to prolonged hospital stay and higher
mortality. In the last decades several treatment modalities have been described, of which vacuum-assisted closure (VAC) shows
the most promising results. The aim of this study is to describe clinical outcomes of VAC as compared to open packing and to
predict risk factors for mortality. We performed a retrospective analysis of 113 patients with mediastinitis undergoing VAC (n = 89)
or open packing (n = 24) between January 2000 and July 2010. Patient characteristics, risk factors and procedure-related variables
were analysed. C-reactive protein and leukocyte counts were determined on admission and at regular intervals during hospital
stay. We compared length of treatment, treatment failure, hospital stay and mortality. We also analysed risk factors predicting
mortality. In-hospital mortality in the VAC group was 12.4% compared to 41.7% in the conventional group (P = 0.0032). Intensive
care stay was 6.8 ± 14.4 days with VAC therapy compared to 18.5 ± 21.0 days with open packing (P = 0.0081). Significant risk
factors for mortality were pre-operative renal failure and obesity. Our findings indicate that VAC therapy is superior to open
packing, resulting in shorter intensive care stay and improved survival.
Keywords: Vacuum-assisted closure • Mediastinitis • Infection • Sternotomy
INTRODUCTION
Median sternotomy is the most common approach for
cardiac surgery. Despite the use of sterile technique, perioperative antibiotics and careful wound management, surgical
site infections resulting in mediastinitis occur in up to 3% of
patients [1]. Post-sternotomy mediastinitis is debilitating and
often fatal, with high mortality rates of up to 30% [2].
Post-sternotomy mediastinitis can be managed by antibiotic
therapy, wound incision and drainage, debridement, rewiring,
closed irrigation, delayed closure and omental or myocutaneous flap reconstruction [3]. Over the last decades surgical
therapy consisting of debridement followed by open packing
has substantially evolved. Alternative techniques with primary
or delayed mediastinal closure leading to higher success rates
and lower mortality have been described [4]. Of considerable
importance is the use of negative pressure to enhance
wound granulation and closure as initially described by
Davydov et al. in the early 1990s [5]. This technique known
as vacuum-assisted closure (VAC) was later successfully
adapted for surgical wound management by Morykwas et al.
[6]. VAC is an alternative wound healing strategy in poststernotomy mediastinitis and recent studies have reported
promising results although studies comparing VAC with open
packing are scarce [7].
In this study, the effectiveness of VAC was compared to open
packing as either an adjunct to additional therapy ( prior to vascular flap) or as sole therapy (delayed primary closure or secondary granulation). Risk factors for mortality were determined
in patients treated with VAC.
MATERIALS AND METHODS
Study population and data collection
In our centre 19,254 patients were operated via median sternotomy between January 1, 2000 and July 1, 2010. Patients were
included according to the criteria for mediastinitis as described
by the Centers for Disease Control and Prevention [8]. A total of
161 patients (0.84%) were diagnosed to have mediastinitis.
Eighty-nine patients were treated with VAC, 24 patients managed
with open packing. The remaining patients were treated with
other modalities and were therefore excluded. Variables
included in the study are listed in Tables 1 and 2. Incubation
period was defined as the period between primary surgery and
reintervention for mediastinitis. Renal failure was defined as a
creatinine blood level of ≥120 µmol/l. Obesity was defined as a
body mass index >25 kg/m2. Treatment failure was defined as
© The Author 2011. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
CARDIAC GENERAL
Abstract
18
R.J. Vos et al. / Interactive CardioVascular and Thoracic Surgery
the need for re-intervention or as death of the patient as a
consequence of mediastinal infection.
Table 1:
Baseline characteristics
Mediastinitis: classification and treatment
Post-sternotomy mediastinitis was classified into five subtypes
based on the presence or absence of risk factors, the duration of
the incubation period and previous failed therapies according to
Oakley and Wright [3]. The severity of mediastinitis was classified
based on the level of tissue infiltration: the subcutaneous tissue
(1), the sternum (2) or the pericardial sac (3).
All patients underwent surgical intervention on an urgent
basis. The sternotomy was fully re-opened under general anaesthesia. Extensive debridement of the wound was performed. In
the open-packing group, wounds were irrigated with hydrogen
peroxide, saline and diluted povidone–iodine solution, followed
by packing with gauzes. This procedure was repeated on a daily
basis.
In the VAC group a suction system was inserted in the wounds
(KCI International, San Antonio, TX, USA). The technique for VAC
application has been described by Obdeijn et al. [9]. VAC consists
of polyurethane foam placed in the wound connected to a
computer-controlled suction unit. In addition to this, we used a
tailored polyvinyl alcohol dressing placed substernal to protect
vital structures. The wounds were covered with a transparent
sterile adhesive drape. The therapy unit delivered a continuous
negative pressure of 75–125 mmHg. The VAC dressings were
changed twice a week till the microbiological cultures were
negative. Eight patients (9%) were able to go home with the
vacuum system. The criteria for VAC removal were, negative bacterial culture, absence of fever, falling C-reactive protein levels
and clinically healthy granulating wound. Sternal wounds were
then allowed to close by secondary intention or closed
surgically depending on their size. All patients received adequate
antibiotic therapy.
Outcome and evaluation
Regular blood chemistry and cell counts were performed, at
diagnosis of mediastinitis (t0), at t1 (3–7 days after t0), at t2 (8–13
days after t0) and at t3 (14–21 days after t0).
Time interval between primary surgery and development of
mediastinitis, in hospital stay, VAC and antibiotics therapy interval
were registered. Completion of therapy was defined as the
delayed primary closure of the sternum, until secondary wound
healing was achieved, or use of a myocutaneous flap. Patients
who were discharged home with VAC were reviewed weekly at
our specialized outpatient wound clinic.
Sex (male)
Age (years)
COPD
Diabetes
Hypertension
Immunosuppressive drugs
Renal failure
BMI
C-reactive protein
missing
<20 (mg/l)
20–80 (mg/l)
>80 (mg/l)
Leukocyte count (g/l)
Haemoglobin (g/dl)
VAC group
N = 89
Conventional
group N = 24
P-value
61 (68.5%)
67.9 ± 10.1
23 (26.1%)
36 (40.4%)
36 (40.4%)
2 (2.2%)
23 (25.8%)
27.6 ± 5.1
19 (79.2%)
74.6 ± 8.4
11 (45.8%)
6 (25%)
13 (54.2%)
2 (8.3%)
6 (25%)
27.2 ± 3.9
0.4453
0.0041
0.1074
0.2493
0.3314
0.4182
0.8576
0.7150
28 (31.5%)
51 (57.3%)
5 (5.6%)
5 (5.6%)
9.4 ± 3.8
12.6 ± 1.9
9 (37.5%)
10 (41.7%)
3 (12.5%)
2 (8.3%)
10.2 ± 3.0
11.1 ± 2.7
0.3636
0.3709
0.0053
COPD, chronic obstructive pulmonary disease; BMI, body mass index.
Table 2:
Surgical procedure variables
VAC group
N = 89
Previous surgical procedure
Emergency operation
CABG
LIMA
RIMA
AVR
MVR/MVP
Other operation
Duration of surgery
Extra corporeal
circulation time
Aorta occlusion time
Conventional
group N = 24
23 (25.8%)
1 (4.2%)
5 (5.6%)
0 (0.0%)
76 (85.4%) 19 (79.2%)
71 (82.6%) 19 (79.2%)
24 (28.6%) 12 (50%)
17 (19.1%)
6 (25.0%)
8 (9.0%)
2 (8.3%)
13 (15.3%)
6 (25.0%)
173 ± 71
238 ± 106
99 ± 50
130 ± 74
65 ± 38
77 ± 48
P-value
0.0431
0.5297
0.9349
0.0857
0.7253
0.7607
0.4225
0.0381
0.0354
0.4148
CABG, coronary artery bypass graft; LIMA, left internal mammary
artery; RIMA, right internal mammary artery; AVR, aortic valve
replacement; MVR, mitral valve replacement; MVP, mitral valve repair.
of a likelihood ratio test. All statistical analyses were performed
in R (R for windows version 2.13; www.r-project.org).
RESULTS
Statistical analysis
Patient population and characteristics
Standard descriptive statistics are given. Comparison of groups
was performed by Student’s t-test, Mann–Whitney test or
Chi-square test where appropriate. For time-related variables
Kaplan–Meier estimates and log-rank test were computed. We
used a mixed effect model with the square root transformed
C-reactive protein ( producing a near Gaussian distribution) to
test the difference between groups and course in time by means
One hundred and thirteen patients with mediastinitis were
included in this study of which 89 were treated with VAC and 24
with open packing. Patient characteristics and laboratory values
are shown in Table 1. Statistically significant differences in age
and preoperative haemoglobin value were seen. No differences
were observed in variables related to the initial surgical procedure
(Table 2). Time between primary operation and re-operation for
mediastinitis in the VAC group ranged from 6 to 333 days (median
22) versus 6–92 days (median 17) in the conventional group.
Pathogens of mediastinitis
Type and severity of the mediastinitis are showed in Table 3. The
majority of tissue cultures from mediastinitis patients showed
Staphylococcus aureus (68 patients) or coagulase- negative
Staphylococcus strains (11 patients). Three patients had positive
cultures demonstrating Staphylococcus epidermidis, two patients
had Escherichia coli, two patients had Proteus mirabilis, two
patients had Serratia marcescens and one patient had Klebsiella
pneumoniae. One patient had methicillin-resistant S. aureus in
the tissue cultures. Other pathogens seen included Pseudomonas
aeruginosa, Enterococcus faecalis and Enterococcus faecium. In 13
patients the tissue culture remained negative, most likely due to
prior antibiotic treatment. In both groups S. aureus was detected
in the majority of tissue cultures; 62.9% in the VAC group versus
62.5% in the conventional group.
Outcome
19
P = 0.0081). In the VAC group, hospitalization due to mediastinitis
was 74 ± 61 days compared to 69 ± 62 days in the open-packing
group (P = 0.9778). In-hospital mortality was significantly lower
in the VAC group (12.4%) compared to patients treated with
open packing (41.7% P = 0.0032). The crude odds ratio (OR) of
the VAC group compared to the open-packing group on
in-hospital mortality was 0.20 (95% CI = [0.07–0.56 ]). Propensity
adjustment was performed for gender, smoking, C-reactive
protein count, year of start mediastinitis, prior surgery, left internal mammary artery usage, right internal mammary artery
usage, type of mediastinitis and haemoglobin count. Propensity
adjusted OR of the VAC group versus the open-packing group on
in-hospital mortality was 0.18 (95% CI = [0.07–0.46]).
In both groups C-reactive protein levels and blood leukocyte
counts declined significantly compared to their values at diagnosis of mediastinitis (Fig. 1a). Speed and extend of the decline
were not significantly different in both groups.
Out of the 89 patients who received vacuum therapy 62
underwent a procedure for closure. These procedures were
delayed wound closure (n = 23) including reconstruction with
omentum or pectoral muscle flap, while the remaining (n = 39)
had sternal refixation (delayed primary closure) without the use
of additional procedure. In 27 patients, the wound was allowed
to close by secondary intention.
Intensive care stay was shorter in the VAC group compared to
the open-packing group (6.8 ± 14.4 days versus 18.5 ± 21.0 days
Risk factors for mortality
Table 3: Mediastinitis variables
Wound classification
Type I
Type II
Type III
Type IV
Type V
Severity
Mild (1)
Moderate (2)
Severe (3)
VAC group
N = 89
Conventional group
N = 24
P-value
12 (13.6%)
32 (36.4%)
35 (39.8%)
2 (2.3%)
7 (8.0%)
5 (20.8%)
13 (54.2%)
5 (20.8%)
1 (4.2%)
0 (0.0%)
0.0389
2 (2.3%)
9 (10.2%)
77 (87.5%)
1 (4.2%)
1 (4.2%)
22 (91.7%)
0.6116
Risk factors and laboratory values of patients treated with VAC
therapy who died were compared to patients who survived
(Table 4). Cause of death during VAC treatment was mostly
sepsis, heart failure, respiratory insufficiency and bowel ischaemia. Incidence of obesity and renal failure was significantly different between groups. Mediastinitis was severe in all cases (3
on the severity scale) and patients had more polymicrobial infections in the mortality group compared to the surviving group.
Speed and extent of decline of C-reactive protein and leucocytes
were less in the mortality group compared to the surviving
group (Fig. 1b). The mixed effects modelling showed an overall
statistical significant difference between groups of C-reactive
protein values (P < 0.001) as well as a different course in time
between both groups (P = 0.0275).
Figure 1: C-reactive protein levels and leukocyte course. A shows the decline in C-reactive protein level and leukocyte count in both the VAC-treated group and
the open packing group. B shows the decline in C-reactive protein level of the surviving and mortality group in VAC-treated patients.
CARDIAC GENERAL
R.J. Vos et al. / Interactive CardioVascular and Thoracic Surgery
R.J. Vos et al. / Interactive CardioVascular and Thoracic Surgery
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Table 4: Predicting factors for mortality in patient
receiving VAC therapy
Surviving group
N = 78
Sex (male)
52 (67.5%)
Age (years)
67.3 ± 10.3
COPD
18 (23.7%)
Diabetes (any)
30 (39.0%)
Hypertension
32 (41.6%)
Renal failure
14 (18.2%)
BMI
27.0 ± 5.0
Severe mediastinitisa
66 (84.6%)
Staphylococcus aureus in
51 (65.4%)
tissue culture
Mortality group
N = 11
P-value
8
71.7
5
5
3
8
30.7
11
5
1.0
0.1825
0.2442
0.9344
0.5644
0.0004
0.0296
0.3483
0.3174
(72.7%)
± 9.3
(45.5%)
(45.5%)
(27.3%)
(72.7%)
± 3.7
(100%)
(45.5%)
COPD, chronic obstructive pulmonary disease; BMI, body mass index.
3 on the severity scale.
a
be strong predictors for mortality in our VAC-treated patients.
We have also shown that slow decline of C-reactive protein
levels are indicative of treatment failure suggesting an increased
risk of in-hospital mortality.
Our results are in accordance with previous studies showing
that in-hospital stay was shorter, rewiring was earlier and survival
tended to be better when VAC was used [10, 11].
VAC is an effective method to treat post-sternotomy mediastinitis. Possible drawbacks of VAC have recently been delineated
in cases of right ventricle wall rupture due to the high negative
pressure [13]. Despite protection of the vital structures by polyvinyl alcohol dressings, right ventricle rupture occurred in one
patient in our study.
This study shows that VAC is superior to open packing in poststernotomy mediastinitis. VAC reduces mortality, increases
sternal stability, patient comfort and can be used in an outpatient situation. Pre-operative renal failure and obesity are risk
factors for mortality in VAC-treated patients.
Conflict of interest: none declared.
DISCUSSION
Post-sternotomy mediastinitis is a devastating complication with
high mortality rates. Failure of open-packing therapy for mediastinitis aggravates an already complicated situation. VAC was
introduced in the late 1990s as a therapeutic modality for the
treatment of post-sternotomy mediastinitis [7]. Local application
of uniform suction achieved with VAC therapy permits arteriolar
dilatation promoting granulation tissue proliferation. This technique decreases excess fluids and oedema, reducing bacterial
colonization of the wound and reducing the need for dressing
changes [6]. We have been using VAC for the treatment of mediastinitis at our department since 1999. VAC has been compared
several times with open packing during the last decade [10, 11].
Our study, however, includes the largest group of patients
treated with VAC.
Our study demonstrates that VAC reduces intensive care stay
and mortality. We were able to implement VAC therapy in a
domiciliary setting, increasing mobilization, physical and emotional wellbeing of patients. Eight patients could leave the hospital with the VAC system in situ, visiting the outpatient clinic
twice a week. The change of dressings was performed by specially trained nurse practitioners. This increases patient comfort
and may lead to cost reduction [12].
Our mortality rates are similar to the earlier reported results,
confirming the benefits of VAC therapy compared to open
packing [13]. Sjogren et al. reported lower mortality rates in their
VAC group compared to our results. A possible explanation for
this observed difference could be the incidence of renal failure
[10]. The incidence of pre-operative renal failure was higher in
our group and we found this to be a strong predictor for mortality. Open packing was mostly used in the period between 2000
and 2002 while VAC was used from 2000 till 2010. Improved
medical care during the last years could have positively affected
mortality in the VAC group, although we do not see a decline of
mortality in the VAC group over time.
Risk factors for mediastinitis have been previously reported
[14]. We report for the first time risk factors for in-hospital mortality of VAC-treated patients. Karra et al. recently published
several risk factors for 1-year mortality in patients with mediastinitis [15]. These results, however, were not specific for patients
treated with VAC. Obesity and renal failure have been shown to
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R.J. Vos et al. / Interactive CardioVascular and Thoracic Surgery
Authors: Georgios Dimitrakakis1, Agamemnon Pericleous1, Dimitrios
Challoumas1 and Inetzi A. Dimitrakaki2
1
Department of Cardiothoracic Surgery, University Hospital of Wales, Heath Park,
Cardiff, CF144XW, UK
2
Department of Cardiology, Metropolitan Hospital, N. Faliro, 18547 Athens, Greece
doi: 10.1093/icvts/ivr049A
© The Author 2011. Published by Oxford University Press on behalf of the
European Association for Cardio-Thoracic Surgery. All rights reserved.
The retrospective study by Vos et al. has reported on the superiority of VACtherapy compared to open packing in patients with post-sternotomy mediastinitis
(PM) [1].
We have reviewed our experience regarding the management of deep sternal
wound infections (also commonly called PM) in 85 patients over a period of 11
years (2000–2010) where the in-hospital mortality rate for this specific group was
7% vs. 3% . The higher logistic EuroSCORE for these patients (10.2% vs. 7.9%) indicates the higher rate of preoperative co-morbidities [2]. Our therapeutic approach
is consistent with immediate application of VAC-therapy plus systemic antibiotics
even when there is no clear distinction of whether there is an infective deep
sternal wound or not [2]. This approach may improve the wound healing process
through the early removal of the infective tissues and reduction of dead space. In
case of sternal dehiscence, further surgical revision is required. Upon resolution of
acute infection and confirmation of wound cultures as negative, a primary sternal
closure technique is applied followed by insertion of closed irrigation - suction
drains [2].
Bilateral myocutaneous pectoral flap reconstruction can be performed when necessary with particular emphasis on the preservation of its vascular supply. Six
percent of these patients required a further plastic intervention [2].
In 2003, Luckraz et al. found that VAC-therapy combined with primary closure or
myocutaneous flap is superior to VAC-therapy alone in patients with PM (VAC duration 13.5 days vs. 8 days, healed scar 77% vs. 64%, mortality rate 7.7% vs. 28.6%)
[3]. The overall cost of the VAC-therapy per patient was regarded as nearly $4000
cheaper per patient than the single use of a closed irrigation system [3].
Pectoralis flaps can frequently be used for the definitive treatment of PM and the
final sternal reconstruction. These flaps, as described by Jurkiewicz et al., allow
early closure and healing of sternal wounds and are currently the conventional
treatment for PM [4]. Alternatively, omental flaps can also be used for the treatment of PM specifically in the case of replacement of the ascending aorta with a
prosthetic graft [4].
In 2007, Raja and Berg published their meta-analysis regarding the routine use of
VAC-therapy in all patients with deep sternal wound infections post cardiac
surgery. The authors identified 13 papers (out of 198) representing the best evidence in the use of VAC-therapy [5]. All the studies were retrospective or small
cohort and the largest one was by Agarwal et al. with 103 patients (64% had the
definitive diagnosis of PM) [5]. According to Agarwal et al., all the patients were
treated with VAC-therapy (average period 11 days/patient) of whom 68% had definitive chest closure. The overall mortality rate was 28%, however, no deaths were
related to VAC-therapy. Four deaths were due to PM sepsis [5].
This meta-analysis illustrates that VAC-therapy is a safe and effective additional
method for the surgical management of PM. However, a prospective doubleblinded randomized controlled trial is essential in order to validate the effectiveness, cost effectiveness and improvement of quality of life of patients undergoing
VAC-therapy [5].
Conflict of interest: none declared.
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Interact CardioVasc Thorac Surg 2012;14:17–20.
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closure as a treatment modality for infections after cardiac surgery. J Thorac
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[4] Milano CA, Georgiade G, Muhlbaier LH, Smith PK, Wolfe WG. Comparison of
omental and pectoralis flaps for poststernotomy mediastinitis. Ann Thorac
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[5] Raja SG, Berg GA. Should vacuum-assisted closure therapy be routinely used
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CARDIAC GENERAL
eComment. Vacuum-assisted closure therapy in cardiac surgery
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