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      Is Seprafilm valuable in infant cardiac redo procedures?

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          Abstract

          Background

          Morbidity and mortality are higher for cardiac reoperations than first operation due to the presence of post-operative adhesions. We retrospectively evaluated the efficacy of the bioresorbable membrane Seprafilm® to prevent pericardial adhesions after cardiac surgery in a paediatric congenital heart disease population.

          Methods

          Seventy-one children undergoing reoperations with sternotomy redo and cardiopulmonary bypass for congenital malformations were included. Twenty-nine of these patients were reoperated after previous application of Seprafilm® (treatment group). The duration of dissection, aortic cross clamping and total surgery were recorded. A tenacity score was established for each intervention from the surgeon’s description in the operating report.

          Results

          In multivariate analysis, the duration of dissection and the tenacity score were lower in the treatment than control group (p < 0.01), independent of age and interval since preceding surgery.

          Conclusion

          Our results suggest that Seprafilm® is effective in reducing the post-operative adhesions associated with infant cardiac surgery. We recommend the use of Seprafilm® in paediatric cardiac surgery when staged surgical interventions are necessary.

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          Most cited references12

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          Adverse events during reoperative cardiac surgery: frequency, characterization, and rescue.

          To (1) determine frequency of occurrence and risk factors for intraoperative adverse events (IAE) during reoperative cardiac surgery, (2) characterize them with respect to structure injured, timing, and use of preventive strategies, and (3) identify the impact on outcome in terms of successful and unsuccessful rescue and cost. Operative notes of 1847 patients undergoing reoperative cardiac surgery were reviewed to identify and characterize documented intraoperative adverse events. Logistic regression modeling was used to identify risk factors for intraoperative adverse events and outcomes. Expected versus observed poor outcomes (stroke, myocardial infarction, death) was used to measure rescue. Among 127 patients, 145 (7%) intraoperative adverse events occurred. These included injuries to bypass grafts (n = 47), heart (n = 38), and great vessels (n = 28) and ischemia without graft injury (n = 22). Most occurred on opening (n = 34, 23%) and during prebypass dissection (n = 57, 39%). Risk incremented as reoperations increased. Seventy-seven patients experienced 1 or more lapses in preventive strategies. Patients with intraoperative adverse events had a greater number of poor outcomes (n = 24 [19%] vs n = 107 [6.2%]; P < .0001) and incurred higher direct technical intraoperative and postoperative costs (ratio 1.3). Twelve patients with intraoperative adverse events were predicted to have poor outcomes versus 24 who did (P < .0001), indicating 12 "failures to rescue." Adverse events still occur regularly during cardiac reoperation, are related to complexity of the procedure, and occur particularly during dissection and often when preventive strategies have not been used. Compensatory rescue measures are not always successful. Adverse events lead to poor patient outcome and higher cost.
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            Seprafilm® adhesion barrier: (1) a review of preclinical, animal, and human investigational studies

            The aim of this study was to provide a single site resource for investigators, clinicians, and others seeking preclinical, animal, and human investigational studies concerning the postsurgical, anti-adhesion barrier Seprafilm™ (Genzyme Corporation, Cambridge, MA). All published preclinical, animal, human extra-abdominal research as of July 2011 have been summarized and included in this document. Searches of Medline and EMBASE Drugs and Pharmaceuticals databases were conducted for original preclinical, animal, and human extra-abdominal studies involving Seprafilm. Preclinical, animal, and extra-abdominal human investigational studies are the study selection for this manuscript. Intraabdominal use is discussed in the accompanying manuscript. Data extraction includes systematic manuscript review. Summary of preclinical, animal, and extra-abdominal human investigational use of Seprafilm by surgical discipline were gathered for data synthesis. The clinical use of Seprafilm, which was approved by the FDA for intra-abdominal procedures, is supported by preclinical and animal studies relating to general surgical and obstetrical/gynecological applications. Findings from preclinical, animal, and human investigational studies at other sites throughout the body raises the potential for additional human clinical trials to assess efficacy and safety following surgical procedures at non-abdominal locations.
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              Postsurgical intrapericardial adhesions: mechanisms of formation and prevention.

              Postsurgical intrapericardial adhesions are still considered an unavoidable consequence of cardiothoracic operations. They increase the technical difficulty and the risk of reoperations. The pathogenesis of postsurgical adhesions is a multistep process, and the main key players are (1) loss of mesothelial cells, (2) accumulation of fibrin in areas devoid of mesothelial cells, (3) loss of normal pericardial fibrinolysis, and (4) local inflammation. Today, very promising methods to reduce adhesions are available for clinical use. This report reviews the process of formation of adhesions and the methods to prevent them, classified according to the mechanism of action.
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                Author and article information

                Contributors
                bruno.lefort@univ-tours.fr
                jeanmarcelarid@hotmail.com
                anne_lorrainebouquiaux@hotmail.com
                n.soule@chu-tours.fr
                j.chantreuil@chu-tours.fr
                elsa.tavernier@univ-tours.f
                chantepie@med.univ-tours.fr
                p.neville@chu-tours.fr
                Journal
                J Cardiothorac Surg
                J Cardiothorac Surg
                Journal of Cardiothoracic Surgery
                BioMed Central (London )
                1749-8090
                31 March 2015
                31 March 2015
                2015
                : 10
                : 47
                Affiliations
                [ ]Children Hospital Gatien de Clocheville, Tours, France
                [ ]University François Rabelais, Tours, France
                [ ]INSERM, CIC 202, Tours, France
                Article
                257
                10.1186/s13019-015-0257-2
                4383064
                8e8c15ba-9ab6-4bbc-995c-2b8465c470f2
                © Lefort et al.; licensee BioMed Central. 2015

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 26 November 2014
                : 23 March 2015
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2015

                Surgery
                congenital heart disease,cardiac reoperation,tissue adhesives,biomaterials
                Surgery
                congenital heart disease, cardiac reoperation, tissue adhesives, biomaterials

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