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      Initial experience with a synthetic sealant PleuraSeal™ after pulmonary resections: a prospective study with retrospective case matched controls

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          Abstract

          The objective of this study was to evaluate postoperative outcome and efficacy of a hydrogel tissue sealant for prevention of alveolar leakage after open lung resections.

          20 consecutive patients were enrolled in the PleuraSeal™ sealant group (PSG) and case matched with 20 retrospective controls (CG) with standard treatment. Assessment of postoperative air leakage was performed until chest tube removal. Patients were followed until 30 days after discharge.

          At end of surgery, 100% in the PSG and 0% in the CG were air leak free (p < 0.001). Duration of postoperative chest tube suction was shorter in PSG (p < 0.001), and air leak chest tube was removed earlier (p = 0.03). Limitation for chest tube removal due to a pulmonary leak was 35% in CG and 5% in PSG (p = 0.04). Patients remaining air leak free thru discharge was 95% and 15% for PSG and CG (p < 0.001).

          The study demonstrated a superior efficacy of PleuraSeal™ sealant compared with standard surgical treatment for sustained sealing of postoperative air leakage and causes shorter air leak chest tube duration.

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          Characterization and importance of air leak after lobectomy.

          Air leak after pulmonary resection is a common occurrence that is incompletely characterized. Our objectives were to determine prevalence of air leak and identify its risk factors, characterize its duration and discover its correlates, and evaluate its clinical importance. Air leak was studied in 319 patients undergoing isolated anatomic lobectomy between January 1998 and July 2001. Risk factors for air leak were identified by logistic regression of patient characteristics, indications for lobectomy, lobe resected, and fissure management. Factors associated with air leak duration were sought by time-related analysis. Association of complications with air leak was evaluated by propensity-matched pairs analysis. Prevalence: Air leak prevalence was 58% (186 patients). It occurred less frequently after left lower lobectomy (p < 0.0001) and later in the series (p = 0.008). It was surgeon dependent (p = 0.007) but not associated with forced expiratory volume in 1 second. The 10th, 50th, and 90th percentiles of air leak duration were 1.6, 3, and 7 days, respectively. No factors, including fissure management, were reliably associated with air leak duration. Air leak was associated with more complications (30% vs 18%, p = 0.07) and protracted hospital course (p = 0.02). Postoperative air leak is a common occurrence after lobectomy, but fortunately it is self-limiting in most patients. Air leak is independently associated with longer hospital stay and other postoperative complications. Surgical technique is important and may be the only modifiable factor.
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            Patient and surgical factors influencing air leak after lung volume reduction surgery: lessons learned from the National Emphysema Treatment Trial.

            Although staple line buttressing is advocated to reduce air leak after lung volume reduction surgery (LVRS), its effectiveness is unknown. We sought to identify risk factors for air leak and its duration and to estimate its medical consequences for selecting optimal perioperative technique(s), such as buttressing technique, to preempt or treat post-LVRS air leak. Detailed air leak data were available for 552 of 580 patients receiving bilateral stapled LVRS in the National Emphysema Treatment Trial. Risk factors for prevalence and duration of air leak were identified by logistic and hazard function analyses. Medical consequences were estimated in propensity-matched pairs with and without air leak. Within 30 days of LVRS, 90% of patients developed air leak (median duration = 7 days). Its occurrence was more common and duration prolonged in patients with lower diffusing capacity (p = 0.06), upper lobe disease (p = 0.04), and important pleural adhesions (p = 0.007). Duration was also protracted in Caucasians (p /= 0.2). Postoperative complications occurred more often in matched patients experiencing air leak (57% vs 30%, p = 0.0004), and postoperative stay was longer (11.8 +/- 6.5 days vs 7.6 +/- 4.4 days, p = 0.0005). Air leak accompanies LVRS in 90% of patients, is often prolonged, and is associated with a more complicated and protracted hospital course. Its occurrence and duration are associated with characteristics of patients and their disease, not with a specific surgical technique.
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              Air leaks after lobectomy increase the risk of empyema but not of cardiopulmonary complications: a case-matched analysis.

              To assess whether the presence and duration of air leaks after lobectomy are associated with an increased incidence of cardiopulmonary complications. Propensity score analysis was used on 726 patients undergoing pulmonary lobectomy from 1995 through 2004 to form three well-matched pairs of patients: patients with prolonged air leak (PAL) [> 7 days] and without air leak; patients with short air leak (SAL) [< or = 7 days] and without air leak; and patients with SAL and PAL. These matched groups were then compared to assess postoperative hospital stay and early outcome. Patients with SAL had a longer postoperative hospital stay compared to patients without air leak (8.6 days vs 7.8 days, respectively; p < 0.0001) but had similar morbidity and mortality. Patients with PAL had a longer postoperative hospital stay compared to patients without air leak (16.2 days vs 8.3 days, respectively; p < 0.0001) and with SAL (16.9 days vs 9 days, respectively; p < 0.0001), but similar cardiopulmonary complications were noted between the groups. Patients with PAL had a higher rate of empyema compared to patients without air leak and with SAL (8.2% vs 0%, p = 0.01 and 10.4% vs.1.1%, p = 0.01, respectively). The presence of air leak was not associated with an increased incidence of cardiopulmonary morbidity but was associated with an increased risk of empyema. Future prospective studies are needed to confirm safety of fast track in patients with air leak.
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                Author and article information

                Journal
                J Cardiothorac Surg
                Journal of Cardiothoracic Surgery
                BioMed Central
                1749-8090
                2010
                16 June 2010
                : 5
                : 50
                Affiliations
                [1 ]Department of Thoracic Surgery, University Medical Centre Freiburg, 79106 Freiburg, Germany
                [2 ]Biostatistical Consulting Inc., 10 Mall Road, Suite 200, Burlington, MA 01803, USA
                Article
                1749-8090-5-50
                10.1186/1749-8090-5-50
                2898668
                20553612
                a4f4865a-7b69-4144-97ae-da91136468e2
                Copyright ©2010 Dango 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
                : 12 March 2010
                : 16 June 2010
                Categories
                Research article

                Surgery
                Surgery

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