PMID- 38090287
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231213
IS  - 2072-1439 (Print)
IS  - 2077-6624 (Electronic)
IS  - 2072-1439 (Linking)
VI  - 15
IP  - 11
DP  - 2023 Nov 30
TI  - Safety and usability of an endo staple line reinforcement device for pulmonary 
      resections.
PG  - 6151-6159
LID - 10.21037/jtd-23-1019 [doi]
AB  - 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/m(2). 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.
CI  - 2023 Journal of Thoracic Disease. All rights reserved.
FAU - Kesler, Kenneth A
AU  - Kesler KA
AD  - Indiana University Department of Surgery, Thoracic Section, Indiana University 
      Health, Indianapolis, IN, USA.
FAU - Zeltsman, David
AU  - Zeltsman D
AD  - Department of Thoracic Surgery, Northwell Health, New Hyde, NY, USA.
FAU - Martin, Linda W
AU  - Martin LW
AD  - Department of Thoracic Surgery, University of Virginia, Charlottesville, VA, USA.
FAU - Cassidy, Emily
AU  - Cassidy E
AD  - Department of Thoracic Surgery, Our Lady of the Lake Medical, Baton Rouge, LA, 
      USA.
FAU - Wheeler, Andrew
AU  - Wheeler A
AD  - Department of Surgery, Missouri University Health, Columbia, MO, USA.
FAU - Hammoud, Zane
AU  - Hammoud Z
AD  - Department of Thoracic Surgery, Henry Ford Health Systems, Detroit, MI, USA.
FAU - Popoff, Andrew
AU  - Popoff A
AD  - Department of Thoracic Surgery, Henry Ford Health Systems, Detroit, MI, USA.
FAU - Baudendistel, Jo-El
AU  - Baudendistel JE
AD  - Medical Affairs Department, Ethicon, Inc., Cincinnati, OH, USA.
FAU - Veldhuis, Paula P
AU  - Veldhuis PP
AD  - Medical Affairs Department, Ethicon, Inc., Cincinnati, OH, USA.
FAU - Sadowsky, Mordechai G
AU  - Sadowsky MG
AD  - Medical Affairs Department, Ethicon, Inc., Cincinnati, OH, USA.
LA  - eng
PT  - Journal Article
DEP - 20231117
PL  - China
TA  - J Thorac Dis
JT  - Journal of thoracic disease
JID - 101533916
PMC - PMC10713316
OTO - NOTNLM
OT  - Pulmonary surgery
OT  - buttress
OT  - pulmonary air leak
OT  - staple line reinforcement (SLR)
OT  - stapler
COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure 
      form (available at 
      https://jtd.amegroups.com/article/view/10.21037/jtd-23-1019/coif). K.A.K., D.Z., 
      L.W.M., E.C., A.W., Z.H., and A.P. (or their institutions) received study 
      sponsorship from Ethicon, Inc. Additionally, L.W.M. has been a consultant and 
      speaker for Ethicon, Inc. and Z.H. has been a speaker for Ethicon, Inc. J.E.B., 
      P.P.V., and M.G.S. are employees of Ethicon, Inc. The authors have no other 
      conflicts of interest to declare.
EDAT- 2023/12/13 18:42
MHDA- 2023/12/13 18:43
PMCR- 2023/11/30
CRDT- 2023/12/13 13:07
PHST- 2023/07/04 00:00 [received]
PHST- 2023/10/13 00:00 [accepted]
PHST- 2023/12/13 18:43 [medline]
PHST- 2023/12/13 18:42 [pubmed]
PHST- 2023/12/13 13:07 [entrez]
PHST- 2023/11/30 00:00 [pmc-release]
AID - jtd-15-11-6151 [pii]
AID - 10.21037/jtd-23-1019 [doi]
PST - ppublish
SO  - J Thorac Dis. 2023 Nov 30;15(11):6151-6159. doi: 10.21037/jtd-23-1019. Epub 2023 
      Nov 17.