Joshua P Landreneau, MD, MSc1, Andrew T Strong, MD1, Joel S Frieder, MD2, Stacy Brethauer, MD1, Emanuele Lo Menzo, MD2, Samuel Szomstein, MD2, John Rodriguez, MD1. 1Cleveland Clinic, 2Cleveland Clinic Florida
Objective: The United States Food & Drug Administration (FDA) has approved the first new brand of a compatible laparoscopic staplers under the 510(k) process as a substantially similar medical device. This includes reload cartridges that are fully compatible with existing laparoscopic stapler handle systems and are available at significantly less cost than traditional stapler reloads. The goal of the present study was to establish the safety and efficacy of these alternative laparoscopic stapler cartridges for use in bariatric surgery.
Description: Fifty consecutive primary laparoscopic Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) cases were performed by four surgeons at two high-volume, Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) Accredited Centers using laparoscopic stapler reload cartridges from an alternative, cost-effective stapler system produced in the United States. All stapler reload cartridges were deployed using a powered stapler handle system from a traditional, brand-name supplier. Procedural details and perioperative outcomes were prospectively recorded and analyzed.
Results: The fifty consecutive laparoscopic bariatric operations included 22 patients undergoing RYGB and 28 undergoing SG. Thirty-eight patients (76.0%) were female with a mean age of 44.6 years and body-mass index (BMI) of 47.1 kg/m2. All cases were completed via a laparoscopic approach with no intraoperative complications. The mean operative time was 135 minutes in the RYGB cohort and 98 minutes for SG. A total of 316 stapler reload cartridges were deployed. There was one stapler misfire event (0.3%) due to a malfunctioning powered stapler handle system, with identical misfirings reproduced using this handle and name-brand reload cartridges. Minor staple-line bleeding was observed following three stapler deployments (0.9%), with subsequent hemostasis obtained by utilization of hemostatic clips (n=2) or over-sewing of the staple line (n=1). One patient (2.0%) experienced post-operative hemorrhage following SG who underwent diagnostic laparoscopy with oversewing of a bleeding posterior short gastric vessel, unrelated to the staple line. Five patients (10.0%) had subsequent unplanned hospital readmissions for indications unrelated to the stapler system, including three patients (6.0%) with nausea and vomiting and one patient each with dyspnea and diverticulitis. There were no mortalities.
Conclusions: These alternative, FDA-approved laparoscopic stapler reload cartridges appear to be safe and effective for use in laparoscopic bariatric surgery. When deployed using an existing powered handle system from a brand-name supplier, stapler misfiring and staple-line bleeding events were rare. These stapler reload cartridges may have the potential to significantly decrease costs of laparoscopic bariatric surgery without increased risk of procedure-related complications.
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Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 98673
Program Number: ETP744
Presentation Session: Emerging Technology Poster Session (Non CME)
Presentation Type: Poster