Phase 1 Trial Evaluating Safety of Pulmonary Artery Sealing With Ultrasonic Energy in VATS Lobectomy

Abstract

Energy-sealing devices may be useful to divide small pulmonary arteries (PAs) during video-assisted thoracoscopic surgery (VATS) lobectomy. We evaluated the safety of PA branch sealing with an ultrasonic energy vessel-sealing device during VATS lobectomy. The study consisted of a phase 1 trial. Patients planned to undergo VATS lobectomy were prospectively enrolled. Target sample size was 20 patients. Branches of 7 mm or less were sealed and cut with an ultrasonic energy vessel-sealing device. The remainder of the lobectomy was performed in a standard fashion. Intraoperative, in-hospital, and 30-day postoperative bleeding were prospectively recorded. Thirty-three patients were prospectively enrolled. Thirteen patients were not amenable to PA sealing with the vessel-sealing device because all PA branch diameters exceeded 7 mm (n= 10), conversion to thoracotomy (n= 2), and lobectomy not performed (n=1). A minimum of one PA branch was sealed with the device in 20 patients. Fifty-eight PA branches were divided in 20 patients: 31 with ultrasonic device, 24 with endostaplers, 2 with clips, and 1 with sutures. The mean vessel diameter sealed with the device was 4 mm. Two patients were converted to thoracotomy (1 with PA injury during dissection, 1 with PA tumor invasion). No intraoperative or postoperative bleeding was related to ultrasonic PA branch sealing. No postoperative deaths occurred. PA branch sealing for vessels 7 mm or less was safely achieved using an ultrasonic energy vessel-sealing device in VATS lobectomy. Large-scale, prospective, multi-institutional studies are necessary before widespread clinical application of energy for PA branch sealing in VATS lobectomy.