Ethicon's Echelon Flex GST System Demonstrates Significant Reduction in Air Leak Rates During Pulmonary Resections, Highlighting Impact of Stapler Design on Surgical Outcomes

VCBeat (WeChat Official Account: vcbeat) has learned that a recent study found significant differences in how surgical stapler technologies affect air leak rates. Air leaks are the most common complication associated with lobectomy, a thoracic surgical procedure for treating cancer. The study, funded by surgical device manufacturer Ethicon, is scheduled to be presented at the 2019 Annual Meeting of The Society of Thoracic Surgeons (STS).

Ethicon, a subsidiary of Johnson & Johnson Medical Devices Company headquartered in Ohio, USA, has made significant contributions to surgical care for over a century, from inventing the first suture to revolutionizing surgery through minimally invasive techniques.

Ethicon is dedicated to advancing the future of surgery, driven by its mission to address the world’s most pressing healthcare challenges and improve and save more lives, as well as its commitment to treating serious conditions such as obesity and cancer on a global scale. Leveraging advanced surgical technologies and solutions—including innovative sutures, staplers, energy devices, trocars, and hemostatic instruments—Ethicon continuously innovates and seeks breakthroughs in its field.

Using a novel physiological lung model (PLM) that simulates intraoperative and postoperative respiration, researchers directly observed, tracked, and quantified major staple line air leaks from 110 resected and sutured porcine lungs for the first time. Under simulated physiological breathing conditions, Ethicon’s Echelon Flex GST system demonstrated a 20% staple line air leak rate when tested on porcine lungs, compared with a 44% leak rate for Medtronic’s Endo GIA, which employs Tri-Staple technology to create graduated staples or staples of varying lengths.

In addition to observing higher air leak rates in tapered stapler designs, postoperative or spontaneous breathing conditions (simulated via negative-pressure ventilation) were also independently associated with higher air leak rates and volumes compared with positive-pressure ventilation (used to replicate ventilator-assisted breathing).

“Stapler design and ventilation strategy are two critical variables that may influence air leaks, representing one of the greatest challenges we face in thoracic surgery,” said Dr. Seth D. Force, Chief Research Scholar and Director of Thoracic Surgery at Emory Healthcare in Atlanta, Georgia. “Our findings indicate that the lungs and any associated major staple lines exhibit different ventilation performance intraoperatively versus postoperatively, necessitating that developers fully account for stapler design factors and subject staplers to more rigorous testing.”

Based on the study findings, researchers agree that graduated staple lines in thinner areas of lung tissue (parenchyma) fail to prevent air leaks by adequately compressing the tissue, a phenomenon demonstrated in approximately one-quarter of lobectomy procedures. Meanwhile, air leaks are associated with prolonged hospital stays, higher costs, and nearly double the risk of in-hospital mortality. The study authors also concluded that variations in stapler design, as well as differences in the force exerted on tissue by each device during stapling, may contribute to air leaks.

Dr. Edmund Kassis, co-author of Ethicon’s thoracic surgery research and Senior Medical Director, stated, “Growing evidence indicates that not all surgical staplers are equally effective in reducing the high costs and serious complications associated with thoracic surgery. Selecting the appropriate surgical stapler plays a critical role in minimizing common complications in lung surgery, while also lowering costs and reducing patient hospital stays.”

To better understand air leaks, Ethicon collaborated with leading experts in thoracic surgery to develop a novel Physiological Lung Model (PLM) for assessing and quantifying the incidence and volume of air leaks. Unlike any previous benchtop models, the PLM simulates clinical conditions by replicating two respiratory patterns—mechanical ventilation and physiological (or natural) breathing—in ex vivo lung tissue, thereby enabling functional organ characteristics such as gas exchange. No other model is capable of simulating a patient’s physiological respiration and evaluating air leaks in a postoperative setting.

(Compiled by: Yang Fudong)