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Ann Thorac Surg 2005;79:2049-2055
© 2005 The Society of Thoracic Surgeons

Original article: Cardiovascular

Clinical Outcome After Poststernotomy Mediastinitis: Vacuum-Assisted Closure Versus Conventional Treatment

Johan Sjögren, MDa,*, Ronny Gustafsson, MD, PhDa, Johan Nilsson, MDa, Malin Malmsjö, MD, PhDb, Richard Ingemansson, MD, PhDa

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

Accepted for publication December 20, 2004.

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


   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
BACKGROUND: The conventional treatment for poststernotomy mediastinitis usually involves surgical revision, closed irrigation, or reconstruction with omentum or pectoral muscle flaps. Recently, vacuum-assisted closure has been successfully used in poststernotomy mediastinitis. The aim of the present study was to compare the clinical outcome and survival in 101 patients undergoing vacuum-assisted closure therapy or conventional treatment for poststernotomy mediastinitis.

METHODS: One hundred one consecutive patients underwent treatment for poststernotomy mediastinitis: vacuum-assisted closure therapy (January 1999 through December 2003, n = 61) or conventional treatment (July 1994 through December 1998, n = 40). Follow-up was made in April 2004 and was 100% complete. Actuarial statistics were used to calculate the survival rates.

RESULTS: The 90-days mortality was 0% in the vacuum-assisted closure group and 15% in the conventional treatment group (p < 0.01). The failure rate to first-line treatment with vacuum-assisted closure and conventional treatment were 0% and 37.5%, respectively (p < 0.001). There was no statistically significant difference in the recurrence of sternal fistulas after vacuum-assisted closure therapy or conventional treatment: 6.6% versus 5.0%, respectively. Overall survival in the vacuum-assisted closure group was significantly better (p < 0.05) than in the conventional treatment group: 97% versus 84% (6 months), 93% versus 82% (1 year), and 83% versus 59% (5 years).

CONCLUSIONS: Our findings support that vacuum-assisted closure therapy is a safe and reliable option in poststernotomy mediastinitis with excellent survival and a very low failure rate compared with conventional treatment.


   Introduction
Top
 Abstract
 Introduction
Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
Poststernotomy mediastinitis after cardiac surgery is a devastating, and potentially life-threatening, complication. The incidence is relatively low, 1% to 3% [1, 2], but the mortality rate varies between 19% and 29% according to recent studies [1, 3]. Several wound-healing strategies have been established for the treatment of poststernotomy mediastinitis. Conventional forms of treatment usually involve surgical revision with open dressings or closed irrigation, or reconstruction with vascularized soft tissue flaps such as omentum or pectoral muscle. These wound-healing techniques may be used as a single-line therapy or as a combination of procedures, but there is a considerable lack of consensus regarding the optimal surgical management. Conventional treatment has disadvantages such as destabilization of the thoracic cage, prolonged immobilization, or substantial surgical trauma that might be deleterious in a compromised patient [4].

Recently, several studies have reported promising results with the use of vacuum-assisted closure (VAC) therapy in poststernotomy mediastinitis after open heart surgery [5–10]. In these patients, the VAC technique has been successful, either as a single-line therapy [11] or as a procedure for providing optimal conditions for second-line treatment with tissue flaps [12]. We use VAC as a single-line therapy followed by sternal rewiring without the use of tissue flaps.

We have treated 101 patients with culture-verified poststernotomy mediastinitis since July 1994. Conventional treatment was used between 1994 and 1998, and VAC was used between 1999 and 2003. Comparisons of early outcome between VAC therapy and conventional treatment are scarce [13, 14] and, no long-term studies have been performed comparing the clinical outcome of these therapies. The aim of the present study was to compare the failure rate and survival after single-line VAC therapy or conventional treatment in patients with poststernotomy mediastinitis.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 Acknowledgments
 References
 
Between July 1994 and December 2003, 101 consecutive patients were treated for culture-verified poststernotomy mediastinitis at the Department of Cardiothoracic Surgery in Lund, Sweden. During this period the incidence of poststernotomy mediastinitis was 0.9% (101 patients of 11,348 sternotomy procedures). The incidence was stable throughout the 10-year period; however, referrals for cardiac surgery increased during the relevant period. Forty patients diagnosed with poststernotomy mediastinitis underwent conventional treatment (open dressings, closed irrigation, pectoral muscle flaps, or omentum flaps) between July 1994 and December 1998.

In January 1999 the surgeons at our cardiothoracic surgery department changed their standard therapy in cases of poststernotomy mediastinitis from conventional treatment to VAC therapy. Since then, VAC has been used as single-line treatment before sternal rewiring in 61 consecutive patients with poststernotomy mediastinitis. During the initial phase, before VAC therapy had become fully established, 3 patients were treated with conventional techniques at the surgeon’s discretion, and these patients were included in the conventional treatment group.

The preoperative variables, including the EuroSCORE [15], were prospectively collected in the department’s database before surgery (Table 1). EuroSCORE was used to assess the grade of surgical complexity and preoperative status. In addition, information on risk factors considered relevant to poor wound healing, such as diabetes mellitus, obesity, and systemic immunosuppressive therapy [1, 16], was collected from the patients’ medical records. The presence of bilateral mammary artery grafts was not included because this technique was practiced rarely at our department.


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  		Table 1. Patient Characteristics
 
Poststernotomy mediastinitis was defined according to the guidelines of the US Centers for Disease Control and Prevention (CDC) [17]. Diagnosis required at least one of the following criteria: (1) an organism was isolated from 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 isolated from blood culture or culture of drainage of the mediastinal area. However, no patient presenting signs of infection but with negative substernal tissue cultures was included in the study. All patients in this report required surgical revision with removal of the sternal wires. Patients with sterile dehiscences or superficial sternal wound infections were not included. The patients were also classified according to the criteria proposed by El Oakley and Wright (Table 2) [18]. This classification differentiates between time of presentation and preoperative risk factors and ranged from type I to type V in the study population. 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 IIIA is mediastinitis type I in the presence of one or more risk factors. Type IIIB is mediastinitis type II in the presence of one or more risk factors. Type IVA is mediastinitis type I, II, or III after one failed therapeutic trial. Type IVB 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.


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  		Table 2. Poststernotomy Mediastinitis Classification
 
Antibiotic Therapy
Our standard perioperative antibiotic regime during the relevant period was isoxazolyl penicillin 2 g, three doses on the day of operation and the first postoperative day. When poststernotomy mediastinitis was diagnosed, the antibiotic therapy usually commenced with vancomycin intravenously and continued until the results of the tissue cultures became available. The entire panorama of pathogens is presented in Table 3. Thereafter, the antibiotic therapy was adjusted according to bacterial sensitivity and strain. The antibiotic regimen was similar in the VAC group and the conventional treatment group.


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  		Table 3. Culture-Verified Mediastinal Pathogens
 
Vacuum-Assisted Closure Therapy
Between January 1999 and December 2003, 61 patients underwent VAC as a single-line therapy followed by sternal rewiring. All patients underwent initial surgical revision with removal of all sternal wires. Substernal tissue cultures were sent for microbiologic investigation and determination of the antibiotic resistance pattern. The wound was stepwise revised during VAC changes with a sharp spoon and necrotic bone was removed when necessary, but extensive sternectomy was avoided. The VAC system was established in the sternal wound according to the method previously described by our group [11]. The majority of patients was extubated immediately after VAC therapy initiation and left the intensive care unit after 2 to 3 hours. The patients in the VAC group underwent 3.4 ± 2.3 surgical procedures (median 3; range, 2 to 17). These procedures included initial revision with removal of the sternal wires and application of VAC therapy, changes of polyurethane foam, and the final rewiring of the sternum.

Conventional Treatment
Between July 1994 and December 1998, 40 consecutive patients were diagnosed as having poststernotomy mediastinitis. The patients in this group underwent initial surgical revision with complete debridement of the presternal tissue and sternal edges, similar to the VAC group. This revision included removal of fibrins, necrotic tissue, and sternal wires.

The surgical procedure performed (rewiring, open dressings, closed irrigation, pectoral flaps, or omentoplasty) depended on the clinical condition of the patient and the surgeon’s preference. The vascularized soft tissue flaps were performed in cooperation with a plastic surgeon when needed. The different combinations of surgical procedures in the conventionally treated patients are presented in Table 4.


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  		Table 4. Conventional Surgical Wound-Healing Therapies (40 Patients)
 
Open dressings (wound packing) consisted of moist saline gauzes in the mediastinum for 1 or several days. Dressings were changed several times daily in combination with surgical revision. The procedure was concluded with a sterile drape covering the wound and bypass grafts to prevent desiccation. When the wound was considered clean and there was a bed of fresh granulation tissue, the sternum was rewired or, when necessary, additional wound-healing measures were applied (Table 4).

Closed irrigation was initiated with two or three drains in the mediastinum in combination with two thin catheters for irrigation. The sternum was closed in a standard manner with interrupted steel wires. The fascia and skin were closed in separate layers. The wound was irrigated with normal saline solution, without antibiotics, until the infection was considered under control. The drainage tubes were removed in the ward several hours after irrigation had ceased.

Pectoralis flaps were performed as bilateral advancement flaps on the basis of lateral pectoral arterial blood supply. The sternum was adapted with steel wires when possible, depending on the degree of sternal necrosis. Thin drainage tubes were placed under the muscle flaps and in the mediastinum. Subcutaneous tissue and skin were sutured with interrupted sutures. The thin drainage tubes were removed in the ward when only small amounts of fluid were evacuated.

Omentoplasty was performed through an upper midline incision. The omentum flap was mobilized and passed through a hole in the peritoneum to the mediastinum anterior to the pericardium. If possible, the sternum was rewired during omentoplasty. The subcutaneous tissue and skin were then closed over the omental flap with interrupted sutures.

Follow-Up
The study protocol was approved by the ethics committee for clinical research at Lund University, Lund, Sweden. The follow-up was performed in April 2004 and included 337.8 patient-years (VAC group: 145.4 patient-years; conventional treatment group: 192.4 patient-years), and no patient was lost to follow-up (Fig 1). Information about the patients was collected from the computerized database at our department and, when needed, collected retrospectively from the patients’ medical records. The cause of death during follow-up was provided by the National Board of Health and Welfare. Length of stay was calculated according to Domkowski and coworkers [10], ie, after the onset of mediastinitis if it occurred during the same period of hospitalization as the initial cardiac surgery, or the period of hospitalization as a result of separate admission for mediastinitis.



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  		Fig 1. Actuarial survival in the vacuum-assisted closure group (VAC) and conventional treatment (CT) group.

 
Data Analysis
The survival functions for the conventional treatment group and the VAC group were calculated using the Kaplan-Meier method. The survival functions were then compared using the (nonparametric) log-rank test, Breslow’s test, and Tarone-Ware test. The two-sample Student’s t test was used to evaluate continuous variables. For categorical variables, for which the normal approximation was valid, the two-sample proportion test was used. For other categorical variables, Fisher’s exact test was applied. A p value less than or equal to 0.05 was considered statistically significant.


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 Acknowledgments
 References
 
The patients’ preoperative characteristics demonstrated a significantly higher EuroSCORE and significantly more women in the VAC group. All variables are presented in Table 1.

The 90-days mortality was significantly lower in the VAC group than in the conventionally treated group: 0% (0 patients) versus 15% (6 patients; p < 0.01). The 6 patients in the conventionally treated group all died of multiorgan failure caused by severe sepsis. The numbers of failures to respond to first-line VAC treatment were 0% (0 patients) in the VAC group and 37.5% (15 patients) in the conventional treatment group (p < 0.001; Table 4). The patients with failures to first-line and second-line treatment in the conventional treatment group were classified as El Oakley class type IVA and Type IVB, respectively (Table 2). All 61 patients in the VAC group underwent sternal rewiring without tissue flap surgery. In the conventional treatment group, tissue flaps were performed in 57.5% (23 patients; Table 4). There was no significant difference between the VAC group and the conventionally treated group when comparing the rate of polymicrobial infections (Table 3).

There was no significant difference in time from cardiac surgery to diagnosis of poststernotomy mediastinitis between the VAC group and the conventional treatment group: 16 ± 10 days (range, 3 to 71 days) versus 17 ± 16 days (range, 3 to 97 days), respectively. There was no significant difference in treatment duration between VAC and conventional treatment: 12 ± 9 days (range, 2 to 66 days) versus 10 ± 14 days (range, 1 to 53 days), respectively. The total length of stay in the VAC group and conventional treatment group was 25 ± 17 days (range, 7 to 103 days) and 25 ± 20 days (range, 1 to 87 days), respectively (not significant).

There was no significant difference in recurrent sternal fistulas between VAC therapy and conventionally treated patients: 4 patients (6.6%) and 2 patients (5.0%), respectively. The patients were readmitted to our department, and the fistulas were debrided under general anesthesia. The fistulas were obliterated completely, without sternectomy, after removal of the sternal wires followed by VAC therapy or conventional treatment in combination with antibiotic therapy.

Overall survival was significantly better (p < 0.05) in the VAC group than in the conventional treatment group: 96.9% ± 1.0% (n = 59) versus 84.4% ± 5.6% (n = 35) at 6 months, 92.9% ± 3.3% (n = 49) versus 82.4% ± 6.0% (n = 33) at 1 year, and 82.7% ± 6.6% (n = 1) versus 58.7% ± 7.6% (n = 23) at 5 years (Fig 1). There were 7 late deaths in the VAC group and 16 late deaths in the conventional group. None of the late deaths was caused by ongoing infection in either group.


   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
Acknowledgments
 References
 
Poststernotomy mediastinitis was initially treated with surgical revision, with or without multiple open dressing changes, followed by sternal rewiring or secondary healing. Previous authors have reported a mortality of 45% with this approach [19]. One major disadvantage of open dressings is thoracic instability, which requires mechanical ventilation. Prolonged immobilization increases the risk of additional complications such as pneumonia, thrombosis, and muscular weakening. An important step was made when continuous saline solution and antibiotic irrigation was developed by Bryant and colleagues in 1969 [20]. This technique offers a stable sternum, but previous studies have reported unsatisfyingly high rates of failure [13, 21] and mortality [22].

Another established method is the use of vascularized soft tissue flaps. The use of pectoral muscle flaps was initially described by Jurkiewicz and colleagues [23]. Recent studies have reported varying results with pectoral muscle flaps in poststernotomy mediastinitis [24–26]. Other authors have advocated the technique using omentum flaps first described by Lee and coworkers [27] for closure of mediastinal defects [28]. Reconstruction with soft tissue flaps has a relatively low mortality rate according to some reports [24, 28], but may be associated with flap-related morbidity [29].

Vacuum-assisted closure is a novel approach in wound-healing management [30]. During the application of this subatmospheric form of treatment, several advantageous features of conventional treatment are combined. Vacuum-assisted closure allows open drainage that continuously absorbs exudate with simultaneous stabilization of the chest and isolation of the wound. This therapy stimulates granulation tissue formation in combination with an increased blood flow in the adjacent tissue [31]. Furthermore, VAC therapy approximates the wound edges and provides a mass filling effect with a low degree of surgical trauma, without establishing a new wound (eg, abdominal wound in omental flaps).

In the present study, we retrospectively compared VAC therapy in poststernotomy mediastinitis with other wound-management strategies previously used at our department. We have used VAC therapy exclusively as a single-line therapy before sternal rewiring without the use of soft tissue flaps [11]. This wound-healing strategy requires an objective measure to assess the correct time at which to rewire the sternum without recurrent infections. Our group has previously demonstrated that sternal rewiring after VAC therapy can be successfully guided by C-reactive protein levels [32]. These previous findings were confirmed in the present study because we did not observe any 90-days mortality or any failure to first-line treatment in the VAC group. In the conventional treatment group the in-hospital mortality was 15%, and the failure rate to first-line treatment was 37.5%. Furthermore, we did not identify any significant difference in recurrent sternal fistulas between the VAC therapy and conventional treatment groups, 6.6% and 5.0%, respectively.

Our present study constitutes the largest series of patients used to compare single-line VAC therapy with conventional treatment. Catarino and coworkers [13] performed an early, small, retrospective study on a series of patients to compare VAC therapy with continuous irrigation. They demonstrated a significantly greater number of treatment failures with continuous irrigation compared with VAC therapy. Domkowski and colleagues [10] conducted an observational study using VAC therapy as a single-line treatment or as a bridge to tissue flap surgery with very low early mortality (3.7%). However, in this study they included both superficial and deep sternal wound infections. In a recent study, Fleck and coworkers [33] presented lower rates of recurrent mediastinitis using VAC followed by delayed primary closure or pectoralis muscle flaps compared with primary closure. Doss and colleagues [14] reported results with VAC and conventional wound management, but they used VAC as a bridge to tissue flap treatment in 20% of their patients. Doss and coworkers [14] also reported a shorter length of stay and treatment duration after VAC therapy. In our study, we did not observe any significant difference in length of stay or treatment duration between VAC therapy and conventional treatment. One explanation may be that differences in the health-care systems affect the routines regarding discharge to the patient’s home or transfer of patients to the referring hospital. Furthermore, treatment duration varies considerably among different surgical techniques, and therefore, results in different studies should be interpreted with caution.

Another important finding in the present study was the significantly better long-term survival in the VAC group (Fig 1). A possible explanation of this observation may be that an effective wound treatment counteracts the negative long-term effects of a severe infection, such as poststernotomy mediastinitis. Previous studies have reported that mediastinitis is an independent factor with negative influence on long-term survival after coronary artery bypass graft surgery [1, 2, 34]. The reason for this negative prognostic effect is not fully understood, but a severe systemic infection with septic episodes might cause irreversible effects on vulnerable organs such as the heart, kidneys, and bypass grafts.

There are obvious limitations on the results of this study because of its retrospective and nonrandomized design. A randomized study might add further information, but the ideal design is not always feasible in a surgical setting because of practical or ethical reasons. Although partially biased by the fact that the two groups compared date from different periods, this study indicated a significant improvement in overall survival after VAC therapy. However, the number of women was significantly higher in the VAC group, which may disturb this observation. Furthermore, the conventional group included several techniques for poststernotomy mediastinitis management. In our opinion, this heterogeneity reflects surgical reality as there is no consensus regarding the optimal management of poststernotomy mediastinitis.

In conclusion, the present study demonstrates that properly applied VAC therapy is a safe and reliable option in poststernotomy mediastinitis, with excellent survival and very low failure rate compared with conventional treatments.


   Acknowledgments
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
References
 
We would like to thank Johan Ingemansson and Kristoffer Peters (Statistical Solutions IP) for their expert contribution to the statistical analysis. This study was supported by the Magn Bergwall Foundation, the Crafoord Foundation, the County of Skåne Medical Science Fund, the University Hospital of Lund Donation Funds, and the Heart and Lung Foundation of Sweden.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 

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C. Schimmer, S.-P. Sommer, M. Bensch, and R. Leyh
Primary treatment of deep sternal wound infection after cardiac surgery: a survey of German heart surgery centers
Interactive CardioVascular and Thoracic Surgery, December 1, 2007; 6(6): 708 - 711.
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S. Lindstedt, M. Malmsjo, and R. Ingemansson
Blood Flow Changes in Normal and Ischemic Myocardium During Topically Applied Negative Pressure
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S. G. Raja and G. A. Berg
Should vacuum-assisted closure therapy be routinely used for management of deep sternal wound infection after cardiac surgery?
Interactive CardioVascular and Thoracic Surgery, August 1, 2007; 6(4): 523 - 527.
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R. Petzina, M. Ugander, L. Gustafsson, H. Engblom, J. Sjogren, R. Hetzer, R. Ingemansson, H. Arheden, and M. Malmsjo
Hemodynamic effects of vacuum-assisted closure therapy in cardiac surgery: Assessment using magnetic resonance imaging
J. Thorac. Cardiovasc. Surg., May 1, 2007; 133(5): 1154 - 1162.
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J. Sjogren, M. Malmsjo, R. Gustafsson, and R. Ingemansson
Poststernotomy mediastinitis: a review of conventional surgical treatments, vacuum-assisted closure therapy and presentation of the Lund University Hospital mediastinitis algorithm
Eur. J. Cardiothorac. Surg., December 1, 2006; 30(6): 898 - 905.
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J. E. Molina, E. C. Nelson, and R. R.A. Smith
Treatment of postoperative sternal dehiscence with mediastinitis: Twenty-four year use of a single method
J. Thorac. Cardiovasc. Surg., October 1, 2006; 132(4): 782 - 787.
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A. Mokhtari, R. Petzina, L. Gustafsson, J. Sjogren, M. Malmsjo, and R. Ingemansson
Sternal stability at different negative pressures during vacuum-assisted closure therapy.
Ann. Thorac. Surg., September 1, 2006; 82(3): 1063 - 1067.
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U. Sartipy, U. Lockowandt, J. Gabel, L. Jideus, and G. Dellgren
Cardiac rupture during vacuum-assisted closure therapy.
Ann. Thorac. Surg., September 1, 2006; 82(3): 1110 - 1111.
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R. S. George, E. J. Birks, S. Haj-Yahia, C. T. Bowles, A. Hall, A. Khaghani, and M. Petrou
Acinetobacter Mediastinitis in a Heart Transplant Patient
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T. Fleck, R. Moidl, P. Giovanoli, O. Aszmann, A. Bartunek, A. Blacky, M. Grabenwoger, and E. Wolner
A conclusion from the first 125 patients treated with the vacuum assisted closure system for postoperative sternal wound infection
Interactive CardioVascular and Thoracic Surgery, April 1, 2006; 5(2): 145 - 148.
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L. F. L. Almodovar, A. C. Canas, P. P. Lima Canadas, and M. C. Hernandez
Vacuum-assisted therapy with a handcrafted system for the treatment of wound infection after median sternotomy
Interactive CardioVascular and Thoracic Surgery, October 1, 2005; 4(5): 412 - 414.
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