Ethicon ECHELON FLEX Powered Staplers Associated with Improved Clinical and Economic Outcomes in First Real-World Assessment Versus Manual Staplers
Bleeding complications dropped by nearly half when surgeons used a powered stapler as opposed to a manual device in what researchers say is the first real-world assessment of the two technologies in video-assisted thoracoscopic surgery (VATS) for lung cancer. The study, which appears in the peer-reviewed journal, Advances in Therapy, also found a nearly 10 percent reduction in total hospital costs and one day sooner discharge from the hospital associated with the powered-stapling procedures.
The study, “Impact of Powered and Tissue-Specific Endoscopic Stapling Technology on Clinical and Economic Outcomes of VATS Lobectomy Procedures” was funded by Ethicon, part of the Johnson & Johnson Medical Devices Companies, the market leader in powered staplers including ECHELON FLEX, one of the devices used in the study.
“This real-world study shows stapler choice really does matter in significantly reducing bleeding complications and lowering overall costs in VATS lobectomy procedures. The results in favor of powered stapling devices in thoracic surgery are compelling,” said lead study author Daniel L. Miller, MD, Chief, General Thoracic Surgery at WellStar Health System, Mayo Clinic Care Network in Marietta, GA.
A lobectomy is a surgical procedure where an entire lobe of the lung is removed due to lung cancer, infection, chronic obstructive pulmonary disease (COPD) or benign tumors. Between 2 and 10 percent of lobectomies result in bleeding complications.
In the study, VATS lobectomy patients, who were operated on primarily with ECHELON FLEX Powered Staplers, had nearly half the rate of hemostasis-related complications (8.5 percent vs.16 percent) of manual staplers and were hospitalized for estimated 4.9 days versus 5.9 days. Total adjusted hospital costs were about 9 percent more for procedures performed with manual staplers ($26,052 vs. $23,841). Outcomes including discharge status, operating room time and hospital readmissions were not different between the two groups.
For the study, researchers evaluated hospital discharge data of more than 3,550 thoracic patients from more than 700 hospitals that contribute to the Premier Healthcare Database, one of the largest statistically-certified hospital databases in the world. Patients had VATS lobectomy procedures with either powered staplers (659 patients) or manual staplers (3,100 patients) between January 2012 and September 2016. Of the powered staplers used in the study, over ninety-nine percent were ECHELON FLEX Powered Staplers, manufactured by Ethicon. Of the manual staplers used in this study, over seventy-five percent were manufactured by Medtronic, with the balance being manufactured by Ethicon.
In some cases, there were two ECHELON FLEX Powered Staplers used in the procedure versus one manual stapler. A sub-analysis of these cases found improved hemostasis outcomes were associated with use of ECHELON FLEX Powered Vascular Stapler plus another ECHELON FLEX Powered Stapler without increasing costs.
In addition to the ECHELON FLEX Powered Vascular Stapler, Ethicon’s portfolio of thoracic procedural devices includes the ECHELON FLEX GST System, which controls tissue movement, and the HARMONIC HD1000i Shears, designed to address unique challenges in complex open and VATS procedures.
ECHELON FLEX Powered Staplers are tissue-specific devices designed to positively impact patient outcomes. ECHELON FLEX Powered Vascular Stapler’s narrow anvil, increased articulation, and smaller shaft diameter improve access and enables more precise placement on fragile pulmonary vessels including VATS lobectomy for lung cancer.
“We continue to take aim at critical clinical issues such as hemostasis complications through the development of innovative devices like ECHELON FLEX Powered Staplers and the generation of meaningful clinical and real-world evidence that fills knowledge gaps, validates outcomes and better informs everyday decision making,” said Edmund Kassis, MD, Ethicon Sr. Medical Director for Thoracic Surgery.
Lung cancer is the second most common cancer in the US and is by far the leading cause of cancer death among both men and women. According to the American Cancer Society, there will be about 234,030 new cases of lung cancer (14% of new cancers) and about 154,050 deaths from the disease in 2018.