The multicenter clinical trial is the latest from lead investigator Moishe Liberman, M.D., Ph.D., a minimally invasive thoracic surgeon at Centre Hospitalier de l'Université de Montréal (CHUM) in Canada, who has been studying the use of the HARMONIC technology in VATS lobectomies, with a goal of making the approach safer, easier and more reproducible, since 2014.
“The technical difficulty of VATS lobectomy is directly related to pulmonary artery branch manipulation and is one of the main reasons many thoracic surgeons are reluctant to adopt the minimally invasive procedure,” said Dr. Liberman.^ “Hand-held energy devices have the potential to make it less difficult and diminish the risk of pulmonary artery injury. With appropriate training, the use of an ultrasonic vessel-sealing device is a reasonable alternative to endostaplers for PA branches of 7mm or less.”
The study included 150 patients from the United States, United Kingdom and Canada who had 139 lobectomies and 11 segmentectomies. A total of 424 PA branches were divided—239 with the HARMONIC ACE+7, 181 with endostaplers, and four with endoscopic clips. The mean and median PA diameters were 4.7mm/5mm, 10.3mm/10mm, and 6.5mm/6.5mm for each method, respectively. Successful vessel sealing was observed with 98.7 percent of the PA branches divided with HARMONIC ACE+7 and 97.8 percent of those divided with endostaplers (p=0.47). Among the patients with seal failures, one in the ultrasonic energy group required conversion to thoracotomy for vascular repair. There were no reports of postoperative bleeding and no deaths with any sealing method at 30 days.
“This is the most robust clinical trial to date on the potential use of ultrasonic energy for pulmonary artery branch sealing in VATS,” said Edmund Kassis, M.D., senior medical director, Thoracic Surgery, Ethicon. “Ethicon will continue to invest in generating evidence on our advanced energy portfolio, which is the most comprehensive in the world,1 to validate our technologies and bring the benefits of less tissue damage2 with a goal of faster healing for more patients across the globe.”
According to the American Cancer Society, surgeons are increasingly treating early-stage lung cancers with VATS. In the procedure, a thin tube with a tiny video camera attached is placed through a small incision in the side of the chest. One or two other small incisions are made for the insertion of surgical instruments that enable the surgeon to remove a diseased lobe or section of the lung. Because only small incisions are required, there is usually less pain after surgery and a shorter hospital stay compared to a traditional lobectomy or thoracotomy, where the chest is opened with a large incision.3
Ethicon, a leader in advanced energy, with devices used in approximately 24 million procedures worldwide,4 provides intelligent energy solutions with the primary goal of helping patients heal faster. Its focus is to optimize the use of energy to do less tissue damage, advance operating room safety to minimize risks, and partner with customers to create a healthier health system. Ethicon offers an energy portfolio with its HARMONIC ultrasonic, ENSEAL advanced bipolar and MEGADYNE core electrosurgical portfolios to ensure surgeons have the right energy tool for the surgical jobs that are core to their open and laparoscopic procedures.
Ethicon, part of Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Its continuing dedication to Shape the Future of Surgery is built on a commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and its commitment to treat serious medical conditions like obesity and cancer worldwide, Ethicon delivers innovation to make a life-changing impact.
As the world’s most comprehensive medical devices business, Johnson & Johnson Medical Devices Companies are building on a century of experience, leveraging science and technology, to shape the future of healthcare.
* The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.
** Ethicon represents the products and services of Ethicon Inc., Ethicon Endo-Surgery LLC, and certain of their affiliates. All other trademarks are the property of their respective owners.
^ Moishe Liberman, M.D., Ph.D., is a consultant for Ethicon
1 Upon review of product catalogs and websites (Advanced Energy, Core Energy, Surgical Smoke Evacuation) for the respective manufacturers: Medtronic, Olympus, Intuitive Surgical, Conmed. Ethicon (2017). (C2598)
2 In bench-top test on 3‐7 mm porcine carotids that compared electrical energy with efficiency losses subtracted. HARMONIC ACE®+7 Advanced Hemostasis mode (55 Joules) versus LigaSure™ 5mm Blunt Tip (LF1537) at default 2 Green Bars (102 Joules) (p<0.001). As compared to HARMONIC® devices without Adaptive Tissue Technology. (C2871)
4 Internal global sales data as of June 2016