Safety and usability of an endo staple line reinforcement device for pulmonary resections.

Background: Pulmonary resection can present technical challenges for surgeons due to the dissection and closure of tissues, which vary in thickness and elastic properties, occasionally leading to prolonged air leaks. Staple line reinforcements (SLRs) are widely utilized tools for fortifying the stability and integrity of closures in thoracic surgery, however, materials available and ease of use for both surgeon and scrub nurse have been suboptimal. A novel "click-and-go" device pre-loaded with bioabsorbable buttress material was recently developed, the Echelon Endopath SLR (ESLR, Ethicon, Inc., Cincinnati, OH, USA). This prospective study examines the safety and efficacy of this novel device in lung resections. Methods: Adult surgical candidates undergoing primary pulmonary resection (both open and thoracoscopic) where the ESLR would be used were enrolled. Exclusion included reoperation/revision in same anatomical location, hypersensitivity to polyglactin or related products, and body mass index (BMI) ≥46.0 kg/m2. The primary endpoint assessed the incidence of specific device-related adverse events (AEs): prolonged air leak and empyema. Additional endpoints included number of devices replaced during surgery due to slippage or bunching, and surgeon-reported usability responses. Data was summarized for AEs deemed device-related and usability questionnaire responses. Results: A total of 131 subjects were included in the primary endpoint analysis data set with 120 subjects completing the study (91.6%). The mean age at consent was 62.8±12.0 years and 55.7% were female. The most common primary indication for the procedure was malignancy 61.1%, and primary non-malignant lung disease (non-chronic obstructive pulmonary disease) 12.2%. Common procedures performed were wedge resection (58.0%) and lobectomy (34.4%). There were zero reported device-specific/-related AEs which counted toward the primary endpoint. Responses from a usability questionnaire found all surgeons (100.0%) reported the ease of setup was superior to previous devices utilized. Surgeons expressed greater confidence in the buttress material of the ESLR than that of previous SLR devices (strongly agree 88.9%; slightly agree 11.1%). Most also felt that there was less wastage with the click-and-go ESLR (strongly agree 77.8%, slightly agree 11.1%, neutral 11.1%). Conclusions: The ESLR device demonstrates safe and effective performance in this post-market study of specific thoracic procedures. Furthermore, surgeons found this was easier to use.

Large Spontaneous Right Catamenial Pneumothorax with Diaphragmatic Defect and Liver Herniation.

Catamenial pneumothorax is a spontaneous pneumothorax that occurs predominantly women of child bearing age. We describe a case of a 40-year-old nulliparous woman with medical history significant for endometriosis who presented with severe chest tightness of one-day duration. Chest radiography (CXR) showed a large right spontaneous pneumothorax, what was thought to be a 5.6 cm pleural mass at the right lung base. Following pneumothorax diagnosis, the patient underwent emergent right thoracostomy with pigtail catheter placement. A repeat CXR revealed marked re-expansion of the lung but persistence of a right pleural mass. Follow up computed tomography scan of the chest showed a 33 mm diaphragmatic defect with 5.8 x 4.6 x 3.9 cm area of herniated liver corresponding to the presumed pleural mass. Following complete thoracic imaging, patient underwent video-assisted thoracoscopic surgery, mechanical pleurodesis, and open repair of the right diaphragmatic defect. Intraoperatively, an endometrial implant was noted on the chest wall. On postoperative day three, she began her menstrual cycle and was evaluated by gynecologist who recommended hormonal therapy to reduce risk of recurrent pneumothorax. Due to a persistent air leak, the chest tube was transitioned to a Heimlich valve to facilitate home discharge. The patient was discharged on postoperative day eight, seen as outpatient with resolution of air leak and removal of chest tube.

Pleural Gas Analysis for Detection of Alveolopleural Fistulae.

PURPOSE: Visual inspection (VI) of bubbles in the chest drainage unit does not differentiate a true leak of alveolopleural fistula (APF) from a false leak. We hypothesized that detection of elevated levels of carbon dioxide, increase in oxygen content, or both, in pleural gas upon the administration of supplemental oxygen would accurately identify APF. DESCRIPTION: Prospective study comparing pleural gas analysis (GA) with VI to detect APF after surgical lobectomy (n = 50). EVALUATION: APF was found in 22 (44%) patients at the time of analysis. VI revealed air bubbles in 31 (62%) patients, indicating the presence of APF, of whom 12 (38.7%) were false leaks. VI failed to identify APF in 3 (6%) patients that resulted in post-tube removal pneumothorax. By contrast, GA accurately demonstrated APF in 21 patients, with only one false negative and no false positives. GA demonstrated better sensitivity (95.5% vs 86.4%), specificity (100% vs 57.1%), positive predictive value (100% vs 61.3%), and negative predictive value (96.6% vs 84.2%) compared to VI. CONCLUSIONS: Pleural gas analysis is an effective technique to detect APF and can facilitate timely and safe chest tube removal.