New Evidence Shows Association Between Innovation and Reduced Complications in Thoracic Surgery

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Exciting data from the 26th European Society of Thoracic Surgeons meeting shows an association between innovation, and improved patient outcomes and lowered hospital costs. Two studies presented at an Ethicon* sponsored symposium show that significantly lower rates of bleeding complications occurred when ECHELON FLEX Powered Staplers where used,1 and how a first of its kind lung model can identify the cause of air leaks post-surgery.2 With such complications proving costly and dangerous for patients, finding ways to minimize risk is vitally important.1,2

Findings from the first real-world study exploring the impact of powered staplers compared to manual devices in video-assisted thoracoscopic surgery (VATS) for lung cancer, found that bleeding complications dropped by nearly half when surgeons used a powered stapler. The study which has been published in Advances in Therapy, also found a nearly 10% reduction in total hospital costs, and one day sooner discharge from the hospital associated with the powered-stapling procedures.1

“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.3 Between 2-10% of lobectomies result in bleeding complications.4,5

Findings from a lung model study, published in IEEE Transactions on Biomedical Engineering, found that unlike any system before, the novel ex-vivo model was able to successfully replicate a person’s breathing both under ventilated and natural conditions. Developed by Ethicon, in partnership with leading experts in thoracic surgery, the new model simulates the various physiologic environments experienced by an isolated lung during the perioperative period, allowing researchers to monitor how and why air leaks happen.2 Researchers will now be able to explore under clinically relevant conditions, the possible ways to reduce the risk of air leaks,2 a post-operative complication that occurs in 24% of lobectomies and associated with an almost doubled increase in hospital mortality.6

"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.

This year, more than 310,000 adults all over Europe will be diagnosed with lung cancer, and it is approximated that only 18% will survive for longer than five years. Lung cancer is the biggest cancer killer worldwide, causing more deaths than breast and prostate cancer combined.7

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About the Impact of Powered and Tissue-Specific Endoscopic Stapling Technology on Clinical and Economic Outcomes of VATS Lobectomy Procedures

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 99% were ECHELON FLEX Powered Staplers, manufactured by Ethicon. Of the manual staplers used in this study, over 75% were manufactured by Medtronic, with the balance being manufactured by Ethicon.1

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 of manual staplers (8.5% vs.16%), and were hospitalized for an estimated 4.9 versus 5.9 days. Also, total adjusted hospital costs were $23,841, versus $26,052 for procedures performed with manual staplers. Outcomes including discharge status, operating room time and hospital readmissions were not different between the two groups.1

About the Ex Vivo Modeling of Perioperative Air Leaks in Porcine Lungs

Isolated porcine lungs were perfused and ventilated during open chest and closed chest simulations, mimicking intra- and post-operative ventilation conditions. To assess and validate system capabilities, nine porcine lungs were tested by creating a standardized injury to create an approximately 250cc/min air leak. Air leak rates, physiologic ventilation, and perfusion parameters were continuously monitored, while gas transfer analysis was performed on selected lungs. Segmental ventilation was monitored using electrical impedance tomography.2

About the Johnson & Johnson Medical Devices Companies

The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, interventional and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.

About Ethicon

From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing healthcare issues, and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. Learn more at https://www.ethicon.com/emea, and follow us on Twitter @Ethicon.

*Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates. Ethicon Endo-Surgery, Inc. is the legal manufacturer of ECHELON FLEX Powered Staplers. All other trademarks are the property of their respective owners.

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References

  1. Miller DL, Roy S, Kassis ES. et al. Impact of powered and tissue-specific endoscopic stapling technology on clinical and economic outcomes of video-assisted thoracic surgery lobectomy procedures: a retrospective, observational study. Advances in Therapy (2018). https://doi.org/10.1007/s12325-018-0679-z.
  2. Klassen C, Eckert CE, Wong J. et al. Ex Vivo Modeling of Perioperative Air Leaks in Porcine Lungs. IEEE Transactions on Biomedical Engineering (2018). https://ieeexplore.ieee.org/document/8325303/
  3. American Lung Association. Lobectomy. Available at: www.lung.org/lung-health-and-diseases/lungprocedures-and-tests/lobectomy.html. Accessed May 2018.
  4. Kent M, et al. Open, video-assisted thoracic surgery, and robotic lobectomy: review of a national database. Ann Thorac Surg. 2014;97:236-444.
  5. Based on Ethicon (2016) internal analysis of data from 26,955 lobectomy procedures captured in Premier Perspective database for the period of 2008- 2014.
  6. Yoo A, Ghosh SK, Danker W. et al. Burden of air leak complications in thoracic surgery estimated using a national hospital billing database. ClinicoEconomics and Outcomes Research. 2017;9:378-383.
  7. Lung Cancer Europe. Our Diagnosis. Available at: www.lungcancereurope.eu/lung-cancer/. Accessed May 2018.