By Megan Brooks
NEW YORK (Reuters Health) - 10/5/2019
A device that uses ultrasonic energy to seal pulmonary blood vessels during minimally invasive lung cancer surgery is a promising alternative to staplers and clips, researchers reported in a late-breaking clinical trial session May 4 at the American Association for Thoracic Surgery (AATS) annual meeting in Toronto.
Results from a large international study show that it is "possible to safely seal pulmonary blood vessels through ultrasonic sealing and effectively control possible bleeding during a video-assisted thoracoscopic surgery (VATS) procedure," lead investigator Dr. Moishe Liberman, of the Division of Thoracic Surgery, University of Montreal, said in a news release.
The study included 150 patients from the United States, United Kingdom and Canada who had 139 lobectomies and 11 segmentectomies. A total of 424 pulmonary artery (PA) branches were divided -- 239 with the HARMONIC ACE+7 ultrasonic energy device (Ethicon, Johnson & Johnson), 181 with endostaplers, and four with endoscopic clips. The mean PA diameters were 4.7 mm, 10.3 mm, and 6.5 mm for each method, respectively.
Successful vessel sealing was observed with 98.7% of the PA branches divided with ultrasonic energy device and 97.8% of those divided with endostaplers (P=0.47). Only three of the PA branches divided with the ultrasonic vessel-sealing device (1.3%) and four PA branches divided with endostaplers (2.2%) bled intraoperatively.
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 study was what everyone was waiting for to prove that this technique and technology is safe and reproducible in multiple centers with many different surgeons so there should be no more hesitation," Dr. Liberman told Reuters Health by phone.
Currently, only about 15% of lobectomies worldwide are performed by VATS, mainly because of the actual risks of major bleeding or surgeons' perception of these risks, he explained.
"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," Dr. Liberman said in the release. "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."
Dr. Liberman told Reuters Health, "Like with any technology, every surgeon will decide whether they want to use it or not. There is a minor learning curve with the device but not a huge amount and that will all be outlined in the paper to be published and there will be training videos as well. I don't think it will be something that is very hard to adopt."
The results are being submitted to the Journal of Thoracic and Cardiovascular Surgery.
This study received funding from Johnson & Johnson and the Centre hospitalier de l'Université de Montréal (CHUM).
American Association for Thoracic Surgery Annual Meeting 2019.