Real-World Use of a Novel Stapler in Thoracic Procedures: An Interim Analysis

C. Fuller¹, K. D. Mortman², D. Zeltsman³, Z. Hammoud⁴, J. Pineda^5
1Cedars-Sinai, Los Angeles, California ²George Washington University, Washington, District of Columbia ³Northwell Health, New Hyde Park, New York ⁴John Dingell VAMC, Northville, Michigan ⁵Rutgers, Newark, New Jersey

Purpose: In thoracic surgery, staple line integrity is fundamental to favorable clinical outcomes where air leaks and bleeding are common.1,2 Here we present interim results from the real-world use of the Echelon 3000 stapler (E3000) in thoracic procedures.

Methods: The aim of this prospective, observational, multi-center study was to assess the safety and efficacy of the E3000 in patients undergoing thoracic resections. The primary endpoint was incidence of subjects with serious adverse events (SAEs) defined as a prolonged air leak (PAL) beyond 7 days post-op. Secondary endpoints were device-related or procedure-related SAEs or AEs.

Results: Ninety-nine subjects, aged 69.7±11.4 years with a mean BMI of 27.5±5.9 kg/m2, primarily female (54%), have completed the study. Procedures performed included wedge resection (58.6%), lobectomy (36.3%), and segmentectomy (13.1%). The primary indication for intervention was malignancy (80.6%) and the majority of procedures were video-assisted thoracoscopic surgery (89.9%). Mean operative time was 96.9±46.9 min., estimated blood loss 37.3±53.3 mL, and median length of stay was 2 days (0-13 day range). In 99.6% of cases, surgeons reported an acceptable staple line integrity. There was one SAE PAL which was deemed possibly device-related. The patient recovered without sequelae. A total of 133 SAEs and AEs believed to be procedure-related were reported with 2 being deemed potentially device-related. There was no bleeding or infection related to the study device. Three deaths were reported during the study period considered not to be device-related.

Conclusion: In thoracic surgery, the E3000 demonstrated satisfactory safety and performance metrics of thoracic procedures in this interim analysis with a low rate of PAL.

Identify the source of the funding for this research project: Funding for this study was provided by Ethicon, Inc., Cincinnati, OH.