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University of Würzburg, Department of Cardiac and Thoracic Surgery, Oberdürrbacherstraße 6, 97080 Würzburg, Germany
Received 27 October 2007; received in revised form 7 April 2008; accepted 8 April 2008.
* Corresponding author. Tel.: +49 931 2010; fax: +49 931 201 33 009. (Email: Schimmer_c{at}klinik.uni-wuerzburg.de).
| Abstract |
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75 years out of 339 cardiac surgery patients prospectively randomised to receive either conventional sternal closure or a Robicsek type closure. Primary end-points were SD and DSWI; secondary end-points included a composite of clinical parameters; (II) we retrospectively assessed data of 54/5273 patients with mediastinitis regarding the influence of advanced age. In addition, we report an epidemiological overview of different sternal closure techniques. Results: (I) The Robicsek technique showed an impact on SD and DSWI, and several secondary end-points: ventilator support (p
= 0.03), postoperative blood loss (p
= 0.04), and chest pain >3 days (p
= 0.04). (II) A total of 54/5273 (1.02%) patients developed postoperative mediastinitis. Twelve out of 54 (22%) patients died within 6 months of the initial operation. Predictors of mortality were insulin-dependent diabetes mellitus (p
= 0.05), renal insufficiency (p
= 0.01), delayed sternal closure (p
= 0.05), ICU-stay >10 days (p
= 0.01), and methicillin-resistant Staphylococcus aureus (p
= 0.03) or fungal infection (p
= 0.02). Conclusions: No statistical difference in sternal dehiscence or mediastinitis was found irrespective of whether the bilateral and longitudinal parasternal closure or the conventional peri/trans-sternal wiring technique was used, but there was an obvious, positive influence on sternal dehiscence, deep sternal wound infection, and clinical parameters. However, the study population is relatively small.
Key Words: Postoperative sternal wound complications Advanced age Standard wire closure Robicsek technique
| 1. Introduction |
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| 2. Patients and methods |
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75 years old and signed informed consent. Exclusion criteria included patients with infectious disease (hepatitis, and HIV), transverse fractures of the sternum, and paramedian sternotomies. Primary end-points were SD and DSWI. Secondary end-points were a composite of clinical parameters such as length of ventilator support, postoperative blood loss, rate of re-exploration, postoperative delirium, mobilisation on postoperative day 2, chest pain >3 days, hospital-stay, and mortality. The date of diagnosis of DSWI was defined as the date when pus drained from the incision site or the date of sternal debridement. The guidelines of the Center for Disease Control and Prevention provide the following definition of DSWI: (1) bacteria can be isolated from cultures of mediastinal tissue or fluid; (2) evidence of mediastinitis is seen during surgery; or (3) one of the following conditions; chest pain, sternal instability, or fever (>38 °C) are present and there is either purulent discharge from the mediastinum or bacteria can be isolated from a blood culture of drainage originating from mediastinal area. We applied the classification of DSWI based upon El Oakley and Wright (Type I: mediastinitis presenting within 2 weeks after operation in the absence of risk factors, Type II: mediastinitis presenting at 2–6 weeks after operation in the absence of risk factors; Type IIIA: mediastinitis type I in the presence of one or more risk factors; Type IIIB: mediastinitis type II in the presence of one or more risk factors; Type IVA: mediastinitis type I, II, or III after one failed therapeutic trial; Type IVB: mediastinitis type I, II, or III after more than one failed therapeutic trial; Type V: mediastinitis presenting for the first time more than 6 weeks after operation) [6]. The local ethics committee approved this study in compliance with the Helsinki declaration. Informed consent was obtained before operation from each randomised patient. Medical records were checked for demographic, preoperative, operative and postoperative data, and complications. Patients were prospectively randomised on the day of their operation into either group by card allocation.
2.2 Surgical techniques
Preoperative intra, or nasal Mupiracin® was not used in the patients. Group I received conventional sternal closure using six or more transverse stainless steel wires, passed either through the bone by needles, or by encircling the sternal body. Group II received bilateral and longitudinal parasternal wiring described by Robicsek. In brief, continuous running wire sutures are placed parallel with, and on both sides of, the sternum. Each suture is passed alternating anterior–posterior to the costal cartilage up to the level of the second costo-sternal junction. The suture is then reversed and led caudally, posterior where it had been anterior and vice-versa, then tied. After both sides of the sternum have been reinforced in this way, transverse sutures encircling the sternum are placed in the usual manner [5]. In all patients, the wound over the sternotomy was closed in three layers. Both groups received the same antibiotic regimen of cefuroxime 1.5 g i.v. every 12 h for 48–72 h, or until chest and mediastinal drainage tubes are removed.
2.3 Study-part (II): patient population, and inclusion/exclusion criteria
Study (II) is a retrospective analysis of 5273 cardiac surgery patients consecutively operated on between 1994 and 2003 in our institution. All patients with DSWI (n
= 54/5273; 1.02%) after cardiac surgery were included. Exclusion criteria were mediastinitis unrelated to cardiac surgery. Follow-up period was 6 months.
2.4 Statistical analysis
The SPSS statistical software (SPSS, Inc, Chicago, IL) was used to analyse the collected data. The incidences of different risk factors were compared using a
2-test. The prevalence of risk factors and the cumulative incidence of in-hospital sternal wound complications for the two groups were compared with Fisher's exact test for categorical variables and Student's t-test and the Wilcoxon rank sum test for continuous and ordinal variables. The Bonferroni test was used to assess differences within each group. Descriptive statistics are presented as mean ± standard deviation.
| 3. Results |
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Forty-three patients (24 men, 19 women, mean age 77 ± 14 years) were assigned to group I (conventional sternal closure); 41 patients (26 men, 15 women, mean age 77 ± 12 years) to group II (Robicsek closure). Both groups were comparable for patient characteristics and procedure related parameters (Table 1 ).
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| 4. Discussion |
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The current standard for sternotomy closure remains the method of wire-cerclage. Many authors described that sternal halves fixed with wire fixation techniques have proven to be more stable biomechanically than other methods of sternal closure [2,9]. In a previous study concerning the closure of primary sternotomy in high-risk patients in all German heart surgery centres we demonstrated, that the most commonly used technique is the sternal closure described by Robicsek (48 times), 29 surgical heart centres stated that they use more steel/bands, and 20 centres replied that the surgeons switched to the sternal band technique [10] (Fig. 1 ).
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4.1 Epidemiological overview of different sternal closure techniques
4.1.1 Trans-sternal/peristernal wiring
Friberg et al. could prove that the use of seven or more sternal fixation wires was associated with a marked reduction in DSWI (0.4%) compared with employing six or fewer wires (4.2%; p
= 0.001). The authors described that there is growing evidence that an additional wire at the caudal sternum substantially reinforces sternal fixation and has a preventive effect on the incidence of DSWI [16]. Studies on embalmed cadavers [17] and clinical experience suggest that, in most cases, the wire would likely cut through the bone before suture breaking or unwinding due to increased stress. These disadvantages led to the introduction of other surgical techniques in patients with an increased risk for sternal instability.
4.1.2 Bilateral and longitudinal parasternal running wires (described by Robicsek)
In 1977 Robicsek et al. described an alternative method with bilateral and longitudinal parasternal running wires, with alternating sutures passed anteriorly and posteriorly to the costal cartilages down to the xiphoid process. This procedure has several advantages: it stabilises the sternum if it is fragile or broken, or if subsequent instability develops, it prevents the wires cutting through the bone, it changes the site of pressure and provides wider support. The disadvantage of this technique is that it produces a constrictive weave that can disrupt the collateral blood supply of the sternum and effective approximation of the top and bottom of a gaping sternum cannot be obtained [5,9]. This technique was modified by Sutherland et al. and Sharma et al. who placed a line of continuous wire suture on either side of the sternum and tied both lines cranially and caudally. This technique has an added advantage over conventional Robicsek's closure in that the blood supply of the sternum is not strangulated by the ring formed by encircling wires around the costal cartilages by anterior and posterior longitudinal wires [4,9]. Sharma et al. [9] showed in 776 high-risk patients (390 conventional closure vs 386 modified Robicsek technique) that the incidence of PSWC was significantly higher (16 patients) compared to the (1 patient) observed in patients treated with the new technique. Molina et al. reported on 123 obese patients (group I = Robicsek sternal closure technique, n
= 54 vs group II = conventional closure, n
= 69) in a prospective manner. Group I had 0% dehiscence vs group II with 8.7% dehiscence) [18]. Therefore, the bilateral longitudinally parasternal running wire technique, either described by Robicsek or modified by Sharma remains the gold standard for high-risk patients.
4.2 Other techniques
4.2.1 Double wires
Through the double wiring the forces acting on the sternum surfaces are spread out, resulting in an increased resistance to tearing out. Kiessling et al. reported that the incidence of SD was 6/50 patients in the standard techniques group and 1/50 in the double wire group during a follow-up period of 6 months. Disadvantage of the double wire is caused by the soldered point at the end of the wire loop precluding penetration of the manubrium [19]. In a prospective study with 700 patients Bottio et al. assessed the efficacy of an alternative peristernal double crisscross wiring technique (n
= 350) compared to standard trans-sternal closure (n
= 350). The authors demonstrated that the peristernal double crisscross wiring technique achieved greater sternal stability, resulting in a lower incidence of wound infection than the standard technique [3].
4.2.2 Steel band
Closure of median sternotomy with interrupted bands is a variant of peristernal wiring. The disbursement of this force through a larger area, as it occurs with a wider band, lowers the applied stress and possible damage to the bone [5]. Riess et al. described a method putting a steel band at the third intercostal space in addition to standard osteosynthesis with eight wire cerclages. Since the introduction of this procedure, the incidence of SD and DSWI decreased from 2.9% and 0.9% (1999) to 0.3% and 0.2% (2001), respectively [20]. Sternal bands are rigid and do not conform optimally to the sternum, the pressure over a wider surface of sternal periosteum can interfere with nourishing vessels, and bands are difficult to remove at reoperation. No study could show a significant benefit with this system. Even Mersilene tape sternal closure is a method of peristernal wiring. Imagawa et al. [21] described in a prospective randomised study, that Mersilene tape sternal closure were not to be more closely associated with increased complications or patient discomfort.
4.2.3 Figure of eight
The figure-eight closure is described as faster, simpler, and more reliable than its trans-sternal counterpart; with only oblique forces sutures are less likely to loosen or fracture the sternum. The advantage of figure-eight closure is that it allows oblique and horizontal angle of shearing forces instead of direct perpendicular forces. Thus these wires are less likely to loosen or fracture [4,9].
4.2.4 Alternative techniques
Techniques utilising lateral sternal support are first-line options in preventing SD and wound infections. The need to provide lateral reinforcement of the sternum has led to the development of several techniques, such as the use of lateral staples and lateral plates. Techniques like H-shaped titanium plates, reinforced sternal closure system, thermoreactive clips, or rigid plate fixation change the point of contact from metal-to-bone to metal-to-metal. The only prospectively randomised study concerning sternal closure techniques and PSWC in the advanced age population is described by Okutan et al. The authors concluded that the reinforced sternal-closure system provided no additional risk with similar postoperative pain index and postoperative hospital-stay compared with the conventional method. Therefore, this system is reliable to use in elderly patients undergoing open heart surgery, who have additional risk factors for sternal dehiscence [22]. Negri et al. randomised 1000 patients (group I, n
= 500 patients: standard sternal closure vs group II, n
= 500 patients: sternal closure with thermoreactive Nitillium clips). The incidence of PSWC was higher in group I (6.8%) than group II (2.6%; p
= 0.003). The authors concluded, that thermal shape-memory Nitillium clips provided superior results in sternal osteosynthesis following midline sternotomy, due to a considerable reduction of sternal dehiscence and related complications. The clinical benefit of Nitillium clips was even demonstrated in patients with several risk factors for PSWC [23]. Song et al. [2] described rigid plate fixation and showed a significant (p
= 0.006) decrease in the incidence of DSWI when compared to a similar population whose sterna were closed with wire. Pai et al. compared the stability provided by sternal plates with standard wires using an in vitro model. The authors concluded that plating increased stability at the midline compared to wires [24]. Raman et al. use this device even in high-risk patients for primary closure of the sternum after cardiac surgery. This increased stability may facilitate recovery and reduces the substrate for bony infections. Application of this technique in high-risk patients showed a decrease in the incidence of DSWI when compared to similar patients whose sterna were closed with wire. In the wire group (n
= 207) 28 patients developed mediastinitis (14.8%). In the rigid plate fixation group (n
= 215) there was no mediastinitis [25]. But rigid plate fixation of the sternum has not been embraced as the method of choice for primary sternal osteosynthesis for various reasons. Drilling near and around the heart, added time and expense, the difficulty of emergent re-entry and the availability of a simple and effective plating system have all been obstacles to the development and institution of proven technology to the cardiac surgical arena [2].
Because of the small number of the patients the limitation of this study (study-part I) is that there is not enough data to statistically compare the two groups; (study-part II) describes only descriptively and no multivariate logistic regression analysis is possible.
Limitations of the study were that there was no objective assessment of osteoporosis of the sternum. Because the described complication is rare and the study evaluated patients from one institution could only be analysed for a relatively small number of patients no statistically significant difference was seen between primary end-points from group I and II.
In conclusion, none of the above mentioned techniques offers an objective advantage over bilateral and longitudinal parasternal steel wiring in patients
75 years. No statistical difference in sternal dehiscence or mediastinitis was found irrespective of whether the bilateral and longitudinal parasternal closure or the conventional peri/trans-sternal wiring technique was used, but there was an obvious, positive influence on sternal dehiscence, deep sternal wound infection, and clinical parameters. On the basis of these findings and the results of the literature research we have initiated an adequately powered, prospectively randomised multicentre trial comparing osteosynthetic techniques in patients with an increased risk for sternal instability or mediastinitis (advanced age, obesity, chronic lung disease, diabetes mellitus, renal insufficiency, bilateral internal mammary arteries, osteoporosis, corticoid treatment, carcinoma, and peripheral vascular disease).
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