Prospective, multicenter, international phase 2 trial evaluating ultrasonic energy for pulmonary artery branch sealing in video-assisted thoracoscopic surgery lobectomy

Abstract

ObjectivesThe study objectives were to evaluate the immediate, short-, and medium-term efficacy and safety of pulmonary artery branch sealing using an ultrasonic vessel-sealing device in minimally invasive anatomic lung resection. MethodsThis study consists of a prospective, phase 2, multicenter, international clinical trial (clinicaltrials.gov: NCT02719717) that enrolled patients planned for video-assisted thoracoscopic surgery/robotic anatomic lung resection in 7 centers (United States, Canada, United Kingdom). Pulmonary artery branches of 7 mm or less were sealed and divided with an ultrasonic energy vessel-sealing device. The remainder of the lobectomy was performed according to surgeon preference. Intraoperative, in-hospital, and 30-day postoperative bleeding and complications were prospectively recorded. ResultsA total of 150 patients with a minimum of 1 pulmonary artery branch sealed with an ultrasonic vessel-sealing device were prospectively enrolled in the trial. Resections included 139 lobectomies and 11 segmentectomies. A total of 424 pulmonary artery branches were divided: 239 with the ultrasonic vessel-sealing device, 181 with endostaplers, and 4 with endoscopic clips. The mean and median pulmonary artery diameters were 4.7 mm/5.0 mm, 10.3 mm/10.0 mm, and 6.5 mm/6.5 mm for each method, respectively. Three of the pulmonary artery branches divided with the ultrasonic vessel-sealing device (1.3%) and 4 pulmonary artery branches divided with endostaplers (2.2%) bled intraoperatively. Among the patients with seal failures, 1 patient required conversion to thoracotomy. There was no postoperative bleeding from divided pulmonary artery branches with either sealing method. There was no mortality at 30 days. ConclusionsPulmonary artery branch sealing with ultrasonic energy during video-assisted thoracoscopic surgery lobectomy is safe for vessels 7 mm or less. The use of an ultrasonic device is a reasonable sealing method for pulmonary artery branches 7 mm or less.