44. Prospective, Multi-Center, International Phase 2 Trial Evaluating Ultrasonic Energy for Pulmonary Artery Branch Sealing in VATS Lobectomy
*Moishe Liberman1, Eric Goudie1, Chris Morse2, Waël C. Hanna3, *Nathaniel R. Evans4, *Kazuhiro Yasufuku5, Richard Malthaner6, Joel Dunning7, Edwin Lafontaine1, *Pasquale Ferraro1, *Cameron Wright2, Hugh Auchincloss2, *Michael Lanuti2, Jocelyne Martin1, *Harald C. Ott2, *Henning A. Gaissert2, John Sampalis8 1University of Montreal, Montreal, QC, Canada;2Massachusetts General Hospital, Boston, MA;3McMaster University, Hamilton, ON, Canada;4Jefferson University, Philadelphia, PA;5University of Toronto, Toronto, ON, Canada;6University of Western Ontario, London, ON, Canada;7James Cook University Hospital, Middlesbrough, United Kingdom;8McGill University, Montreal, QC, Canada
Invited Discussant: *Scott J. Swanson
Objective: To evaluate the immediate, short- and medium-term efficacy and safety of pulmonary artery (PA) branch sealing utilising an ultrasonic vessel-sealing device in minimally invasive anatomical lung resection. Methods: This study consists of a prospective, Phase II, multi-institutional, international clinical trial (clinicaltrials.gov: NCT02719717) which enrolled patients planned for VATS/robotic anatomical lung resection in seven centers (US, Canada, UK). Diameters of all PA branches requiring division were measured intraoperatively. PA Branches of 7mm 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 post-operative bleeding and complications were reported. Results: A total of 150 patients with a minimum of one PA branch sealed and divided with an ultrasonic vessel-sealing device were prospectively enrolled and included in the trial. Anatomic resections included 139 lobectomies and 11 segmentectomies. A total of 424 PA branches were divided; 239 with the ultrasonic vessel-sealing device, 181 with endostaplers, and 4 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. 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 (p=0.47). Among the patients with seal failures, one patient required conversion to thoracotomy for vascular repair in the ultrasonic energy group. There was no postoperative bleeding from divided PA branches with either sealing method. One patient was re-operated for hemothorax from a bleeding bronchial artery. Mean and median length of stay was 4.1 and 3.8 days, respectively. There was no mortality at 30-days. Conclusions: PA branch sealing with ultrasonic energy during VATS lobectomy is safe for vessels of 7mm or less. With appropriate training, the use of an ultrasonic vessel-sealing device is a reasonable alternative for vascular sealing in PA branches of 7mm or less.