Literature DB >> 31679701

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

Moishe Liberman1, Eric Goudie2, Christopher Morse3, Wael Hanna4, Nathaniel Evans5, Kazuhiro Yasufuku6, John Sampalis7.   

Abstract

OBJECTIVES: The 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.
METHODS: This 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.
RESULTS: A 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.
CONCLUSIONS: Pulmonary 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.
Copyright © 2019 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Entities:  

Keywords:  VATS lobectomy; pulmonary artery; ultrasonic energy; vessel sealing

Year:  2019        PMID: 31679701     DOI: 10.1016/j.jtcvs.2019.09.061

Source DB:  PubMed          Journal:  J Thorac Cardiovasc Surg        ISSN: 0022-5223            Impact factor:   5.209


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3.  Energy devices safety and impact on video-assisted thoracoscopic lung lobectomy postoperative course: monopolar electrocautery versus ultrasonic dissector.

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4.  Commentary: How did that happen?

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