title: Prospective evaluation of biodegradable polymeric sealant for intraoperative air leaks.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01867658 . Registered 3 May 2013.
authors.affiliation: Memorial Sloan Kettering Cancer Center, 1275 York Avenue, Box 531, New York, NY, 10065, USA. parkb@mskcc.org.
authors.forename: Bernard J
authors.initials: BJ
authors.lastname: Park
authors.affiliation: Mercy Health System, Janesville, WI, USA.
authors.forename: John M
authors.initials: JM
authors.lastname: Snider
authors.affiliation: Cardiothoracic & Vascular Surgical Associates, Jacksonville, FL, USA.
authors.forename: Nathan R
authors.initials: NR
authors.lastname: Bates
authors.affiliation: Mayo Clinic, Rochester, MN, USA.
authors.forename: Stephen D
authors.initials: SD
authors.lastname: Cassivi
authors.affiliation: The Heart Hospital Baylor Plano, Plano, TX, USA.
authors.forename: G Kimble
authors.initials: GK
authors.lastname: Jett
authors.affiliation: New York-Presbyterian Hospital, Columbia University, New York, NY, USA.
authors.forename: Joshua R
authors.initials: JR
authors.lastname: Sonett
authors.affiliation: H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
authors.forename: Eric M
authors.initials: EM
authors.lastname: Toloza
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000388:Air; D057868:Anastomotic Leak / Q000209:etiology / Q000628:therapy*; D001672:Biocompatible Materials / Q000008:administration & dosage; D005260:Female; D006801:Humans; D020100:Hydrogels; D007431:Intraoperative Complications; D008297:Male; D008875:Middle Aged; D011013:Pneumonectomy / Q000009:adverse effects* / Q000379:methods; D011092:Polyethylene Glycols / Q000008:administration & dosage; D011183:Postoperative Complications; D011446:Prospective Studies; D065287:Robotic Surgical Procedures; D012709:Serum Albumin / Q000008:administration & dosage; D020775:Thoracic Surgery, Video-Assisted; D014014:Tissue Adhesives / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D001672:Biocompatible Materials; D020100:Hydrogels; D012709:Serum Albumin; D014014:Tissue Adhesives; D011092:Polyethylene Glycols
keywords: Intraoperative air leak; Lung cancer; Lung surgery; Pleural air leak sealant; Postoperative air leak; Robotic surgery; Video-assisted thoracic surgery