Pulmonary artery sealing with ultrasonic energy in open lobectomy: A phase I clinical trial

Abstract Objective Pulmonary artery branch sealing in video-assisted thoracoscopic surgical lobectomy is usually achieved with vascular endostaplers. Iatrogenic pulmonary artery injury may be caused by endostaplers. We evaluated the safety of pulmonary artery sealing with an ultrasonic energy vessel-sealing device in a phase I clinical trial evaluating in vivo safety of the device during open lobectomy. Methods Patients scheduled to undergo elective open (thoracotomy) pulmonary lobectomy were prospectively enrolled. Target sample size was 10 patients. Pulmonary artery diameter was measured intraoperatively. All branches ≤7 mm were divided with an ultrasonic energy vessel-sealing device. The remainder of the lobectomy was performed in a standard fashion. Intraoperative and postoperative bleeding were strictly recorded. Results Eighteen patients were prospectively enrolled. Eight patients were not amenable to pulmonary artery sealing with the device. In the 10 patients included in the analysis, a total of 14 pulmonary arteries were sealed with the ultrasonic device. The mean vessel diameter was 5 mm (range, 2-7 mm). One patient underwent reoperation for bronchial artery bleeding (vessel not sealed with device). There was no intra- or postoperative bleeding related to ultrasonic pulmonary artery sealing. There was no postoperative mortality. Conclusions Pulmonary artery sealing for vessels with diameter ≤7 mm was safely achieved with an ultrasonic energy vessel-sealing device in open lobectomy. The use of ultrasonic energy vessel-sealing devices in video-assisted thoracoscopic surgical lobectomy may have the advantage of making small, short, pulmonary artery branch sealing safer than with vascular endostaplers. Further studies are necessary before widespread application in lobectomy, including video-assisted thoracoscopic surgical lobectomy.