Performance of the ENSEAL X1 Curved Jaw Tissue Sealer in thoracic procedures in a Japanese cohort: a case series report.

Autor: Ito H; Department of Thoracic Surgery, Kanagawa Cancer Center, Yokohama, Japan., Tsuboi M; Department of Thoracic Surgery, National Cancer Center Hospital East, Kashiwa, Japan., Canavan K; Clinical, Ethicon Inc., Cincinnati, OH, USA., Veldhuis P; Medical Affairs, Ethicon Inc., 4545 Creek Rd, Cincinnati, OH, 45242, USA. pveldhui@its.jnj.com., Sadowsky MG; Clinical, Ethicon Inc., Cincinnati, OH, USA.; University of Cincinnati, Cincinnati, OH, USA.
Jazyk: angličtina
Zdroj: General thoracic and cardiovascular surgery [Gen Thorac Cardiovasc Surg] 2024 May; Vol. 72 (5), pp. 331-337. Date of Electronic Publication: 2023 Oct 14.
DOI: 10.1007/s11748-023-01980-1
Abstrakt: Background: Advanced vessel sealing electrosurgical systems have been widely adopted for grasping, cutting, and sealing vessels. Data remain sparse with regard to its use in thoracic procedures. Thus, a prospective case series, utilizing the ENSEAL X1 Curved Jaw Tissue Sealer (X1CJ) and its companion energy source, the Generator 11 (GEN11), in thoracic procedures was performed in a Japanese cohort.
Methods: Subjects were recruited at two Japanese surgical sites. The primary endpoint of this post-market study was the achievement of hemostasis (≤ Grade 3) for each thoracic vessel transection. Performance endpoints included scores for tasks completed with X1CJ (adhesiolysis, lymphatics or tissue bundles divided, tissue grasping, tissue cutting, or tissue dissection); hemostasis grading vessel transected; additional products required to achieve hemostasis for Grade 4 vessel transections. Safety was evaluated by evaluating device-related adverse events. All endpoint data were summarized.
Results: Forty subjects (50.0% female) of Asian ethnicity with a mean age of 67.6 ± 11.3 years underwent a lung resection. Estimated mean blood loss was 39.5 mL. Hemostasis was achieved in 97.5% of vessel transections. Thirty-seven vessel sealings resulted in a hemostatic Grade 1 (92.5%). All surgeons reported satisfaction/neutral in terms of tissue grasping (100.0%) while most reported satisfaction/neutral with tissue cutting (95.7%). One device-related serious adverse event was reported (2.5%), a chylothorax requiring an extension of hospitalization. There was no post-operative bleeding or deaths reported during the study period.
Conclusion: The X1CJ demonstrated safe and effective performance without any reports of significant intra-operative or post-operative hemorrhage in thoracic vessel sealing.
(© 2023. The Author(s).)
Databáze: MEDLINE
Externí odkaz: