Prospective evaluation of biodegradable polymeric sealant for intraoperative air leaks

• Published in: Journal of cardiothoracic surgery Vol. 11; no. 1; p. 168
• Main Authors: Park, Bernard J, Snider, John M, Bates, Nathan R, Cassivi, Stephen D, Jett, G Kimble, Sonett, Joshua R, Toloza, Eric M
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 12.12.2016; BioMed Central
• Subjects: Adult; Aged; Aged, 80 and over; Air; Analysis; Anastomotic Leak - etiology; Anastomotic Leak - therapy; Biocompatible Materials - administration & dosage; Care and treatment; Control; Female; Health aspects; Health care costs; Humans; Hydrogels; Intraoperative Complications; Lung cancer; Male; Middle Aged; Patient outcomes; Pneumonectomy - adverse effects; Pneumonectomy - methods; Polyethylene Glycols - administration & dosage; Postoperative Complications; Prospective Studies; Robotic surgery; Robotic Surgical Procedures; Serum Albumin - administration & dosage; Thoracic surgery; Thoracic Surgery, Video-Assisted; Tissue Adhesives - administration & dosage; Treatment Outcome; United States; Robotic surgery; Pleural air leak sealant; Intraoperative air leak; Lung cancer; Lung surgery; Video-assisted thoracic surgery; Postoperative air leak
• ISSN: 1749-8090; 1749-8090
• DOI: 10.1186/s13019-016-0563-3

A biodegradable polymeric sealant has been previously shown to reduce postoperative air leaks after open pulmonary resection. The aim of this study was to evaluate safety and efficacy during minimally invasive pulmonary resection. In a multicenter prospective single-arm trial, 112 patients with a median age of 69 years (range 34-87 years) were treated with sealant for at least one intraoperative air leak after standard methods of repair (sutures, staples or cautery) following minimally invasive pulmonary resection (Video-Assisted Thoracic Surgery (VATS) or Robotic-Assisted). Patients were followed in hospital and 1 month after surgery for procedure-related and device-related complications and presence of air leak. Forty patients had VATS and 72 patients had Robotic-Assisted procedures with the majority (80/112, 71%) undergoing anatomic resection (61 lobectomy, 13 segmentectomy, 6 bilobectomy). There were no device-related adverse events. The overall morbidity rate was 41% (46/112), with major complications occurring in 16.1% (18/112). In-hospital mortality and 30-day mortality were 1.9% (2/103). The majority of intraoperative air leaks (107/133, 81%) were sealed after sealant application, and an additional 16% (21/133) were considered reduced. Forty-nine percent of patients (55/112) were free of air leak throughout the entire postoperative study period. Median chest tube duration was 2 days (range 1 - 46 days), and median length of hospitalization was 3 days (range 1 - 20 days). This study demonstrated that use of a biodegradable polymer for closure of intraoperative air leaks as an adjunct to standard methods is safe and effective following minimally invasive pulmonary resection. ClinicalTrials.gov: NCT01867658 . Registered 3 May 2013.