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a Universitätsklinik Würzburg, Klinik für Thorax-, Herz- und Thorakale Gefäbchirurgie, Würzburg, Germany
b Klinikum Passau, Klinik für Herzchirurgie, Passau, Germany
c Universitätsklinik Münster, Klinik und Poliklinik für Thorax-, Herz- und Gefäbchirurgie, Münster, Germany
d Städt. Klinikum München GmbH, Klinikum Bogenhausen, Abteilung für Herzchirurgie, München, Germany
e Zentralklinik Bad Berka GmbH, Klinik für Herzchirurgie, Bad Berka, Germany
f Universitätsklinikum Erlangen, Herzchirurgische Klinik, Erlangen, Germany
g Center of Clinical Trial Würzburg (ZKSW), Würzburg, Germany
Accepted for publication August 1, 2008.
* Address correspondence to Dr Schimmer, Universität Würzburg, Klinik und Poliklinik für Thorax-, Herz- und Thorakale Gefäbchirurgie, Oberdürrbacherstrabe 6, Wurzburg, 97080, Germany (Email: schimmer_c{at}klinik.uni-wuerzburg.de).
| Abstract |
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Methods: In this multicenter study, 815 consecutive patients with an increased risk for SWI were prospectively randomly assigned to a conventional osteosynthesis (transsternal or peristernal wiring; n = 440) or to an osteosynthesis with additional lateral reinforcement (Robicsek; n = 375). Primary endpoints were the rate of sternal dehiscence as well as the occurrence of superficial sternal wound infections and deep sternal wound infections.
Results: Both groups were comparable concerning preoperative and intraoperative variables. The rate of sternal dehiscence, superficial sternal wound infections, and deep sternal wound infections (conventional technique 2.5%, 3.4%, 2.5%; and Robicsek 3.7%, 5.6%, 3.7%) did not differ between the groups. Logistic regression analysis found independent risk factors for the development of sternal dehiscence: body mass indes greater than 30 kg/m2 (odds ratio [OR]: 2.9; p = 0.05), New York Heart Association class more than III (OR: 2.4; p = 0.07), impaired renal function (OR: 3.9; p = 0.01), peripheral arterial disease (OR: 3.6; p = 0.001), immunosuppressant state (OR: 3.3; p = 0.001), sternal closure performed by an assistant doctor (OR: 2.5, p = 0.004), postoperative bleeding (OR: 4.2; p = 0.03), transfusion of more than 5 red blood units (OR: 3.7, p = 0.01), reexploration for bleeding (OR: 6.9, p = 0.001), and postoperative delirium (OR: 3.5, p = 0.01). There was an inverse relation between the numbers of wires and DSWI in patients with conventional sternal closure (p = 0.008).
Conclusions: In patients with an increased risk for sternal instability and wound infection after cardiac surgery, sternal reinforcement according to the technique described by Robicsek did not reduce this complication.
| Introduction |
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| Patients and Methods |
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Secondary endpoints included a composite of postoperative clinical variables and in-hospital mortality related to DSWI. Baseline characteristics and perioperative variables were recorded. The technique of wound closure and disinfection protocol was regulated by the study protocol and was performed as follows: In the operating room, the skin is disinfected with polyvinylpyrrolidone (iodine solution). We changed the gloves after the disinfection and before the sternal closure. The method for wound suturing was the same for both groups, namely double-layer sutures up to the intracutaneous skin using Vicryl (Ethicon Inc, Somerville, NJ) sutures. Going from deep up to the surface, the presternal fascia was closed with 1-0 Vicryl sutures in a continuous type. The subcutaneous tissue was closed with 0 Vicryl sutures in a single knot type, and the skin was closed with 3-0 Vicryl sutures in continuous stitches. All patients received prophylactic antibiotic treatment with a second-generation cephalosporin for 48 hours postoperatively adapted to individual weight.
Group 1 conventional treatment group
The conventional closure of the sternum was defined as six or more sutures passed transsternally or peristernally. Transsternal sutures passed approximately 1 cm on each side. Peristernal wires reinforce the lateral table of the sternum, permitting tighter closure with less likelihood of the wires cutting through. The suture wires were then crossed, pulled, and twisted. Care was taken that knotting only occurs at the point where desired, and is not tied under tension. The surplus wire was cut so that the remaining twisted ends of the sutures were bent to lie flat over the sternum [1]. No figure-of-eight or other techniques were used, only single sutures. In every patient, six or more steel wires were used according the axiom "one wire per 10 kg body weight."
Group 2 robicsek treatment group
The method consists of placing continuous, heavy atraumatic wire sutures parasternally on both sides. The suture begins at the upper end of the sternum and is passed alternating anteriorly and posteriorly to the costal cartilages down to the xiphoid process. The suturing is then reversed and led in the cranial direction, passing the cartilages posteriorly where it had been anterior and vice versa. At the upper end of the first rib, the two ends of the suture are then tied together. After the two sides of the sternum are so reinforced, a number of peristernal sutures are passed and tied in the usual manner. Attention was given to pass these sutures laterally to the parasternal continuous sutures but still medial enough to avoid the injury of the mammary vessels [6].
Statistical Analysis
The SPSS statistical software package 15.0 for Windows (SPSS Inc, Chicago, IL) was used. The continuous and normally distributed data are presented as means ± SD. Categorial data were expressed as percentages. Univariate analysis of categorical data was carried out by using the
2 and Fisher exact tests for categorical variables, and unpaired t test or Mann-Whitney U test for continuous variables. Multivariate analysis was assessed with logistic regression to identify risk factors for sternal dehiscence, SSWI, and DSWI. Standard statistical tests were used to calculate odds ratio (OR) and 95% confidence interval (CI). A p value less than 0.05 was considered to indicate statistical significance.
| Results |
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| Comment |
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The current standard for sternotomy closure remains the method of wire circlage (here defined as conventional technique). Many authors described that sternal halves fixed with wire fixation techniques have proved to be more stable biomechanically than other methods of sternal closure [8, 18]. Losanoff and colleagues [16] found in a fresh adult human cadaveric model that mechanical stability of peristernal and alternating peristernal and transsternal wires were significantly greater than pericostal and figure-of-eight closure technique. Friberg and associates [19] 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 growing evidence that an additional wire at the caudal sternum substantially reinforces sternal fixation and has a preventive effect on the incidence of DSWI [19]. Studies on embalmed cadavers 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 [20]. Depending on the amount of movement and tension placed on the point of contact, the bone will often fracture before the period of healing is complete. These considerations led to the adoption of surgical techniques in patients with an increased risk for sternal instability to decrease morbidity, mortality, and hospital costs.
The technique described by Robicsek and coworkers in 1977 has several advantages: it stabilizes the sternum if it is fragile or broken; if subsequent instability develops, it prevents the wires cutting through the bone; it changes the site of pressure and provides wider support, especially if the sternum has been mishandled with the sternum retractor. This technique changes the point of contact from metal to bone to contact of metal to metal. 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 [4, 18]. In a study by Molina and colleagues [21], 123 obese patients were prospectively divided into two groups (Robicsek technique, n = 54, versus standard sternal closure, n = 69). The Robicsek technique group had no dehiscence (0%) versus the standard closure group with 6 dehiscences (8.7%) [21]. The technique described by Robicsek was modified by Sutherland and colleagues and Sharma and coworkers, 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 the conventional Robicsek 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 [10, 18]. Sharma and colleagues [18] showed in 776 high-risk patients (390 conventional closure versus 386 modified Robicsek technique) that the incidence of postoperative sternal wound complications was significantly higher, 16 patients, compared with 1 patient among patients treated with the new technique [18].
Although several methods of sternal closure have been described in literature, for example, additional steel band at the third intercostal space [22], double crisscross [23], and double wires [9]. Khasati and colleagues [24] compared on the basis of 111 papers two different sternal closure techniques (simple wire and figure-of-eight technique). The authors concluded that the figure-of-eight technique revealed no significant advantage over the simple wire technique [24]. Nowadays, many other authors described the benefits of rigid plate fixations. These authors conclude that rigid plate fixation showed a significant decrease in the incidence of postoperative mediastinitis when compared with a similar population of patients whose sternums were closed with wire [2, 8, 12, 25, 26]. Song and associates [15] described rigid plate fixation and showed a significant (p = .006) decrease in the incidence of DSWI when compared with a similar population whose sternums were closed with wire. Pai and associates [12] compared the stability provided by sternal plates with standard wires using an in vitro model, and the authors concluded that plating increased stability at the midline compared with wires. Raman and coworkers [25] used 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 with similar patients whose sternums were closed with wire. In the wire group (n = 207), 28 patients (14.8%) had mediastinitis. 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 reentry, 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 [8]. However, Sharma and colleagues [18] pointed out that none of the alternative techniques like titanium-H-plates, thermoactive clips, and others offers an objective advantage over steel wire encircling [18].
This multicenter trial could not demonstrate that the Robicsek technique results in less sternal dehiscence or sternal infection, nor did this technique positively influence clinical postoperative factors such as mechanical ventilation, blood loss in the intensive care unit, transfusions, reexploration for bleeding, postoperative delirium, intensive care unit stay, hospital stay, and mortality related to DSWI. It was not our intent to establish multiple preoperative, intraoperative, and postoperative risk factors associated with an increased risk for sternal wound complications; these have been done by several other authors and could even be confirmed in this study [1, 18, 27-30]. This study contains the obvious limitations of missing documentation concerning the internal mammary artery preparartion (skelletonized versus nonskelletonized). Furthermore, we only evaluated those cases of sternal dehiscence, SSWI, and DSWI identified before hospital discharge.
In conclusion, the key factor in preventing sternal dehiscence and sternal wound infection is a stable sternal approximation. Careful attention to hemostasis and meticulous surgical technique remain the mainstays of prevention and must include precise sternal alignment and stable closure. The methodologic strength of this trial is that the influence of the surgical performance in a multicenter approach leads to an obvious consideration of the individual surgical influence. Especially if a more complex technique seems theoretically to be superior (one surgeon's results), it is not able to achieve the requirements under "real life" conditions. Therefore, in this setting, we did not observe any benefit of a reinforced osteosynthesis according to the Robicsek technique in patients with an increased risk for sternal wound complications.
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