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Ann Thorac Surg 2005;80:1270-1275
© 2005 The Society of Thoracic Surgeons

Original article: General thoracic

The Impact of Vacuum-Assisted Closure on Long-Term Survival After Post-Sternotomy Mediastinitis

Johan Sjögren, MD, PhD a , * , Johan Nilsson, MD a , Ronny Gustafsson, MD, PhD a , Malin Malmsjö, MD, PhD b , Richard Ingemansson, MD, PhD a

a Department of Cardiothoracic Surgery, Lund University Hospital, Lund, Sweden
b Department of Internal Medicine, Lund University Hospital, Lund, Sweden

Accepted for publication April 5, 2005.

* Address reprint requests to Dr Sjögren, Department of Cardiothoracic Surgery, Heart and Lung Division, Lund University Hospital, SE-221 85 Lund, Sweden (Email: johan.sjogren{at}thorax.lu.se).


   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
BACKGROUND: Post-sternotomy mediastinitis after coronary artery bypass grafting is reported to be a strong predictor for poor late survival when using conventional wound-healing therapies. The aim of this study was to compare the long-term survival after vacuum-assisted closure treated mediastinitis following coronary artery bypass grafting with that of patients without mediastinitis. Another objective was to identify risk factors for developing mediastinitis.

METHODS: Forty-six patients were treated for mediastinitis, with vacuum-assisted closure but without additional tissue flaps, after isolated coronary bypass grafting between January 1999 and September 2004. During this period, 4,781 patients underwent isolated coronary bypass grafting without mediastinitis. Actuarial survival was compared with the log-rank test. Univariate and multivariate analysis were used to identify risk factors for mediastinitis.

RESULTS: There was no difference in early or late survival between the mediastinitis group treated with vacuum-assisted closure and the control group (p = not significant). The survival at 1, 3, and 5 years was 92.9% ± 4.0%, 89.2% ± 5.2%, and 89.2% ± 5.2%, respectively, in the vacuum-assisted closure group; and 96.5% ± 0.3%, 92.1% ± 0.5%, and 86.9% ± 0.8%, respectively, in the control group. Diabetes mellitus, low left ventricular ejection fraction, obesity, renal failure, and three-vessel disease were identified as risk factors for developing mediastinitis.

CONCLUSIONS: This study suggests that patients with vacuum-assisted closure treated mediastinitis may have similar long-term survival as patients without mediastinitis after coronary artery bypass grafting. The independent risk factors identified were similar to those found in previous studies. Our data support that vacuum-assisted closure therapy minimizes the negative effects of mediastinitis on late survival after coronary artery bypass grafting.


   Introduction
Top
 Abstract
 Introduction
Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
Post-sternotomy mediastinitis after coronary bypass surgery grafting is a devastating complication with a reported early mortality rate between 8% and 25% [1, 2]. In addition to increased early mortality, several studies have reported post-sternotomy mediastinitis to be a prognostic factor for poor long-term survival after coronary artery bypass grafting (CABG) [3–8]. The risk of late death is reported to be two to three times higher in patients suffering from mediastinitis after cardiac surgery compared with patients without mediastinitis [4, 7, 8]. The mechanism behind this finding is not fully understood, but it has been suggested that mediastinitis causes irreversible effects on vulnerable structures, such as the heart, the renal system, and bypass grafts [4]. In previous studies demonstrating an increase in late mortality, conventional treatment was used as the wound-healing strategy. Conventional treatment, such as wound packing, closed irrigation, or soft tissue flaps have disadvantages such as high mortality, recurrent infection, or flap-related complications [9–12].

The vacuum-assisted closure (VAC) technique is a relatively new modality in wound-healing management. Local application of negative pressure to a wound results in improved tissue blood flow and increased granulation tissue formation [13, 14]. We have used the VAC technique without additional tissue flaps for post-sternotomy mediastinitis at our department since 1999.

The aim of the present study was to compare the long-term survival of patients with VAC-treated mediastinitis after isolated coronary bypass surgery with that of patients undergoing isolated coronary bypass surgery without mediastinitis. We believe this comparison has not been made before. Furthermore, we also evaluated several preoperative and perioperative variables with univariate and multivariate analysis to identify predictors for developing mediastinitis after CABG.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 Acknowledgments
 References
 
Patient Population and Data Collection
A total of 4,827 patients underwent isolated CABG at our department between January 1999 and September 2004. During this period, 46 of these patients (0.95%) were treated with VAC therapy for culture-verified post-sternotomy mediastinitis. Vacuum-assisted closure therapy has been our standard treatment for mediastinitis since 1999, and the method has been described in detail previously [15]. However, before VAC therapy was fully established, 3 patients were diagnosed with mediastinitis and treated with conventional techniques at the surgeon's discretion. Two of these 3 patients were not included in the study. The third patient underwent initial conventional surgical revision with primary closure (rewiring), but failed to respond to this treatment. Therefore, VAC therapy was initiated and continued until the patient was rewired, and this patient was included in the present study.

Preoperative, perioperative, and postoperative data were collected in the department database in a prospective manner and 20 variables were selected for analysis (Table 1). No patient with previous open heart surgery was included in the study. The medical records of all patients showing postoperative mediastinitis were also reviewed retrospectively. Patients without post-sternotomy mediastinitis were referred to as the control group. The European System for Cardiac Operative Risk Evaluation (EuroSCORE), an established European system for risk stratification in cardiac surgery, was calculated for each patient [16]. Furthermore, the ACC/AHA mediastinitis score, published in the American College of Cardiology/American Heart Association Guidelines for CABG Surgery, was calculated [17].


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  		Table 1. Univariate Analysis of Preoperative and Perioperative Variables
 
Post-sternotomy mediastinitis was diagnosed before discharge of index admission or after readmission from the referring hospitals. Our department was the only cardiothoracic surgery center in the region during the relevant period and patients suffering from infections were readmitted to our department. Post-sternotomy mediastinitis was defined according to the guidelines of the US Centers for Disease Control and Prevention (CDC) [18]; diagnosis of mediastinitis required at least one of the following criteria: (1) an organism was isolated from a culture of mediastinal tissue or fluid; (2) evidence of mediastinitis was seen during operation; or (3) one of the following conditions—chest pain, sternal instability, or fever (>38°C)—was present, and there was either purulent discharge from the mediastinum or an organism was isolated from blood a culture or a culture of drainage fluid from of the mediastinal area. However, all patients diagnosed with mediastinitis and included in the present study had both positive cultures and clinical signs of post-sternotomy mediastinitis and required reoperation with removal of the sternal wires. Patients with negative substernal tissue cultures at the first revision or a superficial sternal wound infection were not included in the study.

The patients were also classified according to the criteria proposed by El Oakley and Wright [19]. Type I is mediastinitis within 2 weeks after operation in the absence of risk factors. Type II is mediastinitis presenting at 2 to 6 weeks after operation in the absence of risk factors. Type III A is mediastinitis type I in the presence of one or more risk factors. Type III B is mediastinitis type II in the presence of one or more risk factors. Type IV A is mediastinitis type I, II, or III after one failed therapeutic trial. Type IV B is mediastinitis type I, II, or III after more than one failed therapeutic trial. Type V is mediastinitis presenting for the first time more than 6 weeks after operation.

Follow-Up
The protocol for the present study was approved by the Ethics Committee for Clinical Research at Lund University, Sweden. Follow-up was performed in November 2004 and included a total of 12 898 patient-years (mean, 2.7 ± 1.7; range, 0 to 5.8). No patient was lost to follow-up. The long-term mortality data during follow-up was provided from the National Board of Health and Welfare.

Statistical Analysis
Continuous variables are expressed as means ± SD. Categorical variables are presented as absolute numbers in addition to percentages. Univariate analysis for continuous variables was conducted with Student's t test or the Mann-Whitney U test. Categorical variables were analyzed with the {chi}2 test, except when expected frequencies were lower than 5, when Fisher's exact test was used. Multivariate analysis was performed using stepwise logistic regression to determine independent predictors of mediastinitis. The inclusion criterion for the full model was p less than 0.2, and the limit for stepwise backward elimination was p less than 0.1. Survival was plotted using the Kaplan-Meier method for all patients surviving 3 days after surgery. Fifty-two patients in the control group, who died during the first 3 postoperative days, were not included in the Kaplan-Meier analysis in an attempt to exclude patients not at risk from mediastinitis [20]. No patient in the mediastinitis group was diagnosed with mediastinitis before 4 days after surgery. The log-rank test was used to compare the difference in survival between the two groups. Cox's proportional hazard analysis was used to risk adjust the Kaplan-Meier survival curve for differences in EuroSCORE [21]. Statistical analysis was performed, and graphs were plotted with the Intercooled Stata version 8.2 statistical package (Stata Corporation, College Station, Texas). A p value less than 0.05 was considered statistically significant.


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 Acknowledgments
 References
 
There were 46 cases of post-sternotomy mediastinitis among a total of 4,827 patients undergoing isolated CABG (0.95%). All 46 patients had sternal rewiring without the use of additional soft tissue flap surgery. The overall 30-day mortality for patients with VAC-treated mediastinitis was 0.0% (0 of 46), and 2.5% (118 of 4,781) in patients without mediastinitis (p = not significant). Patients suffering from mediastinitis had a significantly higher EuroSCORE (6.9 versus 5.2; p = 0.001) and mediastinitis score (4.9 versus 3.5; p < 0.001) than patients without mediastinitis.

There were 4 late deaths (8.7%) in the VAC-treated mediastinitis group during follow-up, but no patient died within 90 days after surgery. None of the deaths in the VAC group was related to the sternal infection: 1 patient died of heart failure, 1 patient died of a cerebrovascular incident, 1 patient died of chronic obstructive pulmonary disease, and 1 died of acute pancreatitis. There were 394 deaths (8.2%) among the patients without mediastinitis during follow-up. The annual incidence of death in the VAC group and the control group is presented in Table 2.


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  		Table 2. Annual Incidence of Death During Follow-Up
 
The log-rank analysis demonstrated no significant difference in late survival between the two groups (p = 0.81). The actuarial survival at 1 year, 3 years, and 5 years was 92.9% ± 4.0% (n = 35), 89.2% ± 5.2% (n = 21), and 89.2% ± 5.2% (n = 5) for patients with mediastinitis (VAC); and 96.5% ± 0.3% (n = 3,806), 92.1% ± 0.5% (n = 1,969), and 86.9% ± 0.8% (n = 578) for patients without mediastinitis (control group), respectively (Fig 1A). No difference in late survival was demonstrated after adjusting the Kaplan-Meier plot for differences in EuroSCORE (Fig 1B).



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  		Fig 1. (A) Actuarial survival of patients with vacuum-assisted closure (VAC)–treated mediastinitis versus nonmediastinitis patients (Control) after isolated coronary artery bypass graft surgery. (B) EuroSCORE-adjusted actuarial survival of VAC-treated mediastinitis patients versus nonmediastinitis patients (Control) after isolated coronary artery bypass graft surgery.

 
The majority of cultures from of the patients with mediastinitis showed coagulase-negative Staphylococcus strains (CoNS) or Staphylococcus aureus. Thirty-eight patients with post-sternotomy mediastinitis had one strain of bacterium shown in their cultures: 27 patients had positive cultures demonstrating CoNS, 5 patients had S aureus, 4 patients had Enterobacter cloacae, and 2 patients had Klebsiella oxytoca in their cultures. Eight patients had two strains of bacteria in their tissue cultures: 2 patients had CoNS plus S aureus, 2 patients had CoNS plus Propionibacterium acnes, 1 patient had CoNS plus Escherichia coli, 1 patient had CoNS plus Proteus mirabilis, 1 patient had CoNS plus Pseudomonas aeruginosa, and 1 patient had Klebsiella pneumoniae plus P acnes demonstrated in the tissue cultures. No patient demonstrated methicillin-resistant S aureus in their tissue cultures. Seven patients were classified as El Oakley type I, 4 patients as type II, 12 patients as type IIIA, 22 patients as type IIIB, and 1 patient as type IVA. No patient had mediastinitis classified as El Oakley type IVB or V.

The results of the univariate analysis of risk factors are presented in Table 1. The patients with mediastinitis were more often obese (47.8% versus 19.1%; p < 0.001) and in New York Heart Association (NYHA) class III/IV (60.9% versus 43.7%; p = 0.02) compared with the control group. Diabetes mellitus was more common among patients with mediastinitis (23.9% versus 6.6%; p < 0.001), as was heart failure (30.4% versus 14.3%; p = 0.004), low ejection fraction (21.7% versus 7.9%; p = 0.003), preoperative renal failure (13.0% versus 1.9%; p < 0.001), and preoperative dialysis (4.3% versus 0.7%; p = 0.05). Furthermore, the mediastinitis group included a higher percentage of patients with three-vessel disease (93.5% versus 64.8%; p < 0.001) and a significantly longer procedure time (216 ± 47 versus 197 ± 50 min; p = 0.005).

The multivariate analysis identified diabetes mellitus, left ventricular ejection fraction less than 30%, obesity (body mass index >30), preoperative renal failure, and three-vessel disease as significant risk factors for developing mediastinitis (Table 3).


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  		Table 3. Multivariate Risk Factors for Poststernotomy Mediastinitis
 

   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
Acknowledgments
 References
 
The present study is the first to suggest similar long-term survival between patients with VAC-treated mediastinitis and patients without mediastinitis after isolated CABG (Fig 1A). This is in contrast to previously published reports regarding long-term survival after mediastinitis. However, in previous studies on long-term survival conventional mediastinitis treatment was used. We believe the successful long-term results found in the present study are due to the use of vacuum-assisted closure without additional tissue flaps as our wound-healing strategy of choice. Vacuum-assisted closure combines several wound-healing principles and may result in minimal sequelae from the infectious episode.

Several studies have suggested that mediastinitis is a strong predictor for poor long-term survival after CABG [2–7]. Braxton and coworkers [8] demonstrated in a large study including 36,078 patients after isolated CABG that actuarial survival after 10 years was 39% among patients with mediastinitis and 70% among patients without mediastinitis. Furthermore, the risk of late mortality was almost twice as high in patients suffering from mediastinitis, even when patients who died within the first 6 months after surgery were excluded [8]. Milano and colleagues [4] have suggested that mediastinitis may cause negative long-term effects on several organs such as the heart and kidneys. Theoretically, a massive immunologic response during a prolonged period of infection may cause adverse effects on bypass grafts.

In previous studies, reporting poor long-term survival after mediastinitis, several conventional wound-healing techniques were used. There is no general consensus regarding the appropriate surgical approach in mediastinitis after open-heart surgery. A commonly accepted wound-healing approach is delayed wound closure including reconstruction with omentum or pectoral flaps [22, 23]. However, there are disadvantages, including additional surgical trauma and late flap-related complications such as pain, weakness, and hernias [10, 24, 25]. Surgical revision with rewiring or closed irrigation offers an expeditious procedure with a closed wound and a stable chest. However, several groups have reported a relatively high rate of therapy failure with these techniques [9, 11, 12, 26]. Therapeutic failure during post-sternotomy mediastinitis treatment is known to aggravate an already difficult situation, and often results in increased early death [27]. Furthermore, ineffective wound management may be harmful, not only in the short term, but also in a longer perspective.

Vacuum-assisted closure is an alternative wound-healing strategy in post-sternotomy mediastinitis and recent studies have reported promising results [28–32]. During the application of this topical negative pressure technique several advantages of conventional treatment are achieved. Vacuum-assisted closure provides an isolated wound with effective drainage in addition to sternal stabilization. This negative pressure system has been demonstrated to stimulate granulation tissue formation [13] and increase the blood flow in adjacent tissue [14]. Furthermore, the negative pressure approximates the sternal wound edges, and the polyurethane foam provides a mass filling effect in the mediastinum without establishing an additional wound in an infected patient, namely, omental or pectoral flap surgery.

The present study demonstrate no difference in long-term survival between patients with VAC-treated mediastinitis and patients without mediastinitis even if patients who died within the first 3 postoperative days were excluded from the control group (Fig 1A). In general, patients suffering from postoperative mediastinitis demonstrated a higher level of comorbidity preoperatively. The univariate analysis showed that patients with mediastinitis were more likely to be obese, and to suffer to a higher extent from diabetes, heart failure, lower ejection fraction, preoperative renal failure, preoperative dialysis, and three-vessel disease than patients without mediastinitis (Table 1). The mediastinitis group also had a longer procedure time and a higher NYHA class when compared with the patients without mediastinitis. In order to minimize effects due to baseline differences, an adjustment in preoperative EuroSCORE was performed although patients suffering from mediastinitis had a significantly higher preoperative EuroSCORE (6.9 versus 5.2; p = 0.001). The EuroSCORE was used since it has been demonstrated to be a predictor of early and late mortality after coronary bypass grafting [33, 34]. However, no difference in long-term survival was observed between the two groups after the adjustment was made (Fig 1B).

The multivariate analysis identified obesity as an independent risk factor (Table 2). Other studies have previously found obesity to be a risk factor for developing post-sternotomy mediastinitis [35, 36]. The mechanism by which obesity leads to this complication is poorly understood but it is likely to be multifactorial. Perioperative antibiotics may be poorly distributed in adipose tissue, as suggested by Milano and coworkers [4]. Furthermore, it may be difficult to diagnose mediastinitis in obese patients during the early phase of the infection. We also found diabetes mellitus to be a risk factor for mediastinitis. This finding is in line with previous reports [1, 2]. Elevated blood glucose levels may impair wound healing, and the use of continuous intravenous insulin has been shown to significantly reduce the incidence of deep sternal wound infection in diabetic patients [37]. A low ejection fraction (< 30%) of the left ventricle was also demonstrated to be a significant risk factor for infection. A reduced ejection fraction is included as a variable in the mediastinitis score proposed by the Northern New England Cardiovascular Disease Study Group [17]. Other studies have identified high NYHA class as a predictor of mediastinitis [4, 38]. Furthermore, preoperative renal failure (creatinine >2.27 mg/dL) was found to be an independent risk factor for developing post-sternotomy mediastinitis. This probably reflects, at least to some extent, a general atherosclerotic condition that may predispose these patients to poor wound healing. Finally, we identified an increased risk of mediastinitis when coronary atherosclerosis affected all main coronary vessels. Again, it is not clear what the true primary cause is. Three-vessel disease probably reflects general vascular pathology leading to longer procedure times, and length of surgery has been demonstrated in previous studies to be a risk factor for post-sternotomy mediastinitis [4].

In conclusion, the present study suggests similar long-term survival between patients with VAC-treated mediastinitis and patients without mediastinitis undergoing isolated CABG. This finding is in contrast to previous reports on long-term survival after mediastinitis; however, in these previous studies, conventional mediastinitis treatment was used. One limitation in the present study is the rather limited sample size in the mediastinitis group, and therefore conclusions regarding survival should be made with caution. We believe that our results are due to the use of VAC therapy without the use of additional soft tissue flap surgery. This approach combines several wound-healing principles and may counteract the negative effects on late survival. In the present work, we also identified independent risk factors similar to those found in previous studies. In our opinion, additional attention should be paid to obese patients, especially when other preoperative comorbidity such as diabetes mellitus, renal failure, low ejection fraction, or extensive coronary artery disease are present.


   Acknowledgments
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
References
 
We would like to thank Johan Ingemansson and Kristoffer Peters (Statistical Solutis IP) for their expert contribution to the statistical analysis. This study was made possible by grants from the Magn Bergwall Foundation, the Medical Funds of the National Board of Health and Welfare, the Region Skåne Research Funds, the Swedish Heart-Lung Foundation, and the Donation Funds of Lund University Hospital, Sweden.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 

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Blood Flow Changes in Normal and Ischemic Myocardium During Topically Applied Negative Pressure
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Should vacuum-assisted closure therapy be routinely used for management of deep sternal wound infection after cardiac surgery?
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Poststernotomy mediastinitis: a review of conventional surgical treatments, vacuum-assisted closure therapy and presentation of the Lund University Hospital mediastinitis algorithm
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Sternal stability at different negative pressures during vacuum-assisted closure therapy.
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