PMID- 36071754
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221216
IS  - 2072-1439 (Print)
IS  - 2077-6624 (Electronic)
IS  - 2072-1439 (Linking)
VI  - 14
IP  - 8
DP  - 2022 Aug
TI  - Clinical outcomes of pre-attached reinforced stapler reloads in thoracic surgery: 
      a prospective case series.
PG  - 2864-2873
LID - 10.21037/jtd-22-220 [doi]
AB  - BACKGROUND: Reinforced staple lines are less susceptible to leaks or bleeding and 
      may consequently reduce morbidity and complications during or after surgery. 
      However, their safety and benefits as well as the best form of reinforcement are 
      still under debate. This study evaluates the safety of a stapler with 
      pre-attached buttressing material based on adverse events (AEs) in thoracic 
      surgery. METHODS: A multi-center prospective study was conducted to assess the 
      use of stapler reloads with pre-attached staple line reinforcement material in 
      thoracic surgery. The primary endpoint was the rate of device-related AEs 
      reported within 30 days of lung cancer thoracic surgery. AEs, bleeding >/=50 mL, 
      leaks, and 30-day readmissions were reported as additional outcomes. RESULTS: A 
      total of 40 patients underwent lobectomy (n=22), wedge resection (n=10), or other 
      thoracic surgery (n=8). Access was open (n=9) or by video-assisted thoracoscopic 
      surgery (VATS, n=31). One patient was lost to follow-up. Intraoperatively, there 
      were no cases of bleeding >/=50 mL requiring staple line intervention, and three 
      cases (8%) experienced minor leaks that were treated conservatively. Bleeding 
      unrelated to the staple line occurred in 20 patients intraoperatively (50%) and 
      21 patients postoperatively (54%). Three patients were readmitted (8%) for 
      procedure-related causes and deemed unrelated to the investigational device. Of 
      the AEs reported, one device-related event occurred intraoperatively, associated 
      with minor bleeding. The other 33 AEs were related to infection (15%), bleeding 
      (12%), or leak (9%). There were no deaths during the follow-up period. 
      CONCLUSIONS: This study demonstrates that AEs related to the use of reinforced 
      reloads and occurring during or within 30 days of lung cancer surgery pose 
      minimal safety concerns.
CI  - 2022 Journal of Thoracic Disease. All rights reserved.
FAU - Lim, Eric
AU  - Lim E
AD  - Imperial College and The Royal Brompton Hospital, London, UK.
FAU - Baste, Jean-Marc
AU  - Baste JM
AD  - Rouen University Hospital, Rouen, France.
FAU - Shackcloth, Michael
AU  - Shackcloth M
AD  - Liverpool Heart & Chest Hospital, Liverpool, UK.
LA  - eng
PT  - Journal Article
PL  - China
TA  - J Thorac Dis
JT  - Journal of thoracic disease
JID - 101533916
CIN - J Thorac Dis. 2022 Nov;14(11):4220-4222. PMID: 36524086
PMC - PMC9442509
OTO - NOTNLM
OT  - Surgical stapler
OT  - adverse events (AEs)
OT  - prospective studies
OT  - staple line reinforcement
OT  - thoracic surgery
COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure 
      form (available at 
      https://jtd.amegroups.com/article/view/10.21037/jtd-22-220/coif). All authors (or 
      their institutions) received study sponsorship, support for data analysis, 
      medical writing support, and research support provided by Covidien (now owned by 
      Medtronic PLC; Mansfield, MA). EL reports grants from AstraZeneca, grants from 
      Boehringer Ingelheim, grants and personal fees from Medela, grants from Lily 
      Oncology, personal fees from Beigene, personal fees from Roche, personal fees 
      from BMS, outside the submitted work; In addition, EL has a patent P52435GB 
      pending to Imperial Innovations, and a patent P57988GB pending to Imperial 
      Innovations and is the founder of My Cancer Companion, a mobile phone application 
      with the aims of improving health, wellbeing and length of life with cancer. JMB 
      reports other from Medtronic, other from Intuitive Surgery, outside the submitted 
      work. The authors have no other conflicts of interest to declare.
EDAT- 2022/09/09 06:00
MHDA- 2022/09/09 06:01
PMCR- 2022/08/01
CRDT- 2022/09/08 02:14
PHST- 2022/02/24 00:00 [received]
PHST- 2022/06/11 00:00 [accepted]
PHST- 2022/09/08 02:14 [entrez]
PHST- 2022/09/09 06:00 [pubmed]
PHST- 2022/09/09 06:01 [medline]
PHST- 2022/08/01 00:00 [pmc-release]
AID - jtd-14-08-2864 [pii]
AID - 10.21037/jtd-22-220 [doi]
PST - ppublish
SO  - J Thorac Dis. 2022 Aug;14(8):2864-2873. doi: 10.21037/jtd-22-220.