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      A new cable-tie based sternal closure system: description of the device, technique of implantation and first clinical evaluation

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          Abstract

          Background

          Wire closure still remains the preferred technique despite reasonable disadvantages. Associated complications, such as infection and sternal instability, cause time- and cost-consuming therapies. We present a new tool for sternal closure with its first clinical experience and results.

          Methods

          The sternal ZipFix TM System is based on the cable-tie principle. It primarily consists of biocompatible Poly-Ether-Ether-Ketone implants and is predominantly used peristernally through the intercostal space. The system provides a large implant-to-bone contact for better force distribution and for avoiding bone cut through.

          Results

          50 patients were closed with the ZipFix TM system. No sternal instability was observed at 30 days. Two patients developed a mediastinitis that necessitated the removal of the device; however, the ZipFix TM were intact and the sternum remained stable.

          Conclusions

          In our initial evaluation, the short-term results have shown that the sternal ZipFix TM can be used safely and effectively. It is fast, easy to use and serves as a potential alternative for traditional wire closure.

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          Most cited references5

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          J. Maxwell Chamberlain memorial paper. Sternal wound complications after isolated coronary artery bypass grafting: early and late mortality, morbidity, and cost of care.

          Of 6,504 consecutive patients who underwent isolated coronary bypass grafting in 1985 to 1987, 72 (1.1%) patients experienced sternal wound complications. Ten patients (14%) with wound complications died of multi-system failure. Only the patients with negative cultures fared well; of the bacterial culture categories, polymicrobial infection carried the worst prognosis. Effects of recurring infection were seen throughout the first year. Patients, grouped according to conduits received, experienced these wound complication rates: vein grafts only, 11/1,085 (1.0%); one internal thoracic artery, 38/4,073 (0.9%); and bilateral internal thoracic artery grafts, 23/1,346 (1.7%). There were no significant differences in wound complication rates between primary and reoperation patients or among conduit groups. By logistic regression analysis, the relative risk for patients with diabetes and bilateral internal thoracic artery grafting was 5.00 (95% confidence interval, 2.4 to 10.5). Operation time as a continuous variable increased the relative risk of wound complication 1.47 times per hour (1.3 to 1.7); obesity, 2.90 times (1.8 to 4.8); and blood units as continuous variable, 1.05 times per unit (1.01 to 1.10). Bilateral internal thoracic artery grafting in nondiabetic patients carried no greater risk of wound complication than that in patients with vein grafts only or with one internal thoracic artery graft.
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            Potential of polyetheretherketone (PEEK) and carbon-fibre-reinforced PEEK in medical applications

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              Prevention of sternal dehiscence and infection in high-risk patients: a prospective randomized multicenter trial.

              One factor for the development of sternal wound infection (SWI) is bony instability after sternotomy. This study compares two surgical techniques with respect to the occurrence of SWI in patients with an increased risk. 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. 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/m(2) (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). 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.
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                Author and article information

                Journal
                J Cardiothorac Surg
                J Cardiothorac Surg
                Journal of Cardiothoracic Surgery
                BioMed Central
                1749-8090
                2012
                25 June 2012
                : 7
                : 59
                Affiliations
                [1 ]Department of Cardiac Surgery, University Hospital Basel, Spitalstrasse 21, CH-4031, Basel, Switzerland
                Article
                1749-8090-7-59
                10.1186/1749-8090-7-59
                3408342
                22731778
                8d692f65-ff10-446f-aa08-24846b250df3
                Copyright ©2012 Grapow et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 11 January 2012
                : 25 June 2012
                Categories
                Research Article

                Surgery
                peek,cable-tie,sternal closure
                Surgery
                peek, cable-tie, sternal closure

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