Prospective evaluation of biodegradable polymeric sealant for intraoperative air leaks

Bernard J. Park, John M. Snider, Nathan R. Bates, Stephen D. Cassivi, G. Kimble Jett, Joshua R. Sonett, Eric M. Toloza

Research output: Contribution to journalArticle

4 Citations (Scopus)

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 69years (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 1month 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 2days (range 1 - 46days), and median length of hospitalization was 3days (range 1 - 20days). 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. Trial registration: ClinicalTrials.gov: NCT01867658. Registered 3 May 2013.

Original languageEnglish (US)
Article number168
JournalJournal of Cardiothoracic Surgery
Volume11
Issue number1
DOIs
StatePublished - Dec 12 2016

Fingerprint

Air
Video-Assisted Thoracic Surgery
Lung
Robotics
Cautery
Chest Tubes
Equipment and Supplies
Segmental Mastectomy
Hospital Mortality
Postoperative Period
Sutures
Polymers
Hospitalization
Morbidity
Safety
Mortality

Keywords

  • Intraoperative air leak
  • Lung cancer
  • Lung surgery
  • Pleural air leak sealant
  • Postoperative air leak
  • Robotic surgery
  • Video-assisted thoracic surgery

ASJC Scopus subject areas

  • Surgery
  • Cardiology and Cardiovascular Medicine

Cite this

Park, B. J., Snider, J. M., Bates, N. R., Cassivi, S. D., Jett, G. K., Sonett, J. R., & Toloza, E. M. (2016). Prospective evaluation of biodegradable polymeric sealant for intraoperative air leaks. Journal of Cardiothoracic Surgery, 11(1), [168]. https://doi.org/10.1186/s13019-016-0563-3

Prospective evaluation of biodegradable polymeric sealant for intraoperative air leaks. / Park, Bernard J.; Snider, John M.; Bates, Nathan R.; Cassivi, Stephen D.; Jett, G. Kimble; Sonett, Joshua R.; Toloza, Eric M.

In: Journal of Cardiothoracic Surgery, Vol. 11, No. 1, 168, 12.12.2016.

Research output: Contribution to journalArticle

Park, BJ, Snider, JM, Bates, NR, Cassivi, SD, Jett, GK, Sonett, JR & Toloza, EM 2016, 'Prospective evaluation of biodegradable polymeric sealant for intraoperative air leaks', Journal of Cardiothoracic Surgery, vol. 11, no. 1, 168. https://doi.org/10.1186/s13019-016-0563-3
Park, Bernard J. ; Snider, John M. ; Bates, Nathan R. ; Cassivi, Stephen D. ; Jett, G. Kimble ; Sonett, Joshua R. ; Toloza, Eric M. / Prospective evaluation of biodegradable polymeric sealant for intraoperative air leaks. In: Journal of Cardiothoracic Surgery. 2016 ; Vol. 11, No. 1.
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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 69years (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 1month 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 2days (range 1 - 46days), and median length of hospitalization was 3days (range 1 - 20days). 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. Trial registration: ClinicalTrials.gov: NCT01867658. Registered 3 May 2013.",
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AU - Sonett, Joshua R.

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AB - 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 69years (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 1month 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 2days (range 1 - 46days), and median length of hospitalization was 3days (range 1 - 20days). 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. Trial registration: ClinicalTrials.gov: NCT01867658. Registered 3 May 2013.

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KW - Video-assisted thoracic surgery

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