Thoracoscopic lobectomy – video-assisted thoracoscopic surgery (VATS) – combined with pulmonary artery sealing using an ultrasonic energy device reduced the risk of post-operative bleeding, complications and pain, found a large international clinical study presented at the 99th Annual Meeting of the American Association for Thoracic Surgery.
Every day, 78 Canadians receive a diagnosis of lung cancer, the most deadly form of cancer in the country. Some of them will have one of the lobes of a lung removed by thoracotomy, a common, but risky surgical procedure that requires months of recovery. However, a less invasive and safer surgical technique exists and could be used more widely.
In a large international clinical study presented at the 99th Annual Meeting of the American Association for Thoracic Surgery, Dr Moishe Liberman, a thoracic surgeon and researcher at the University of Montreal Hospital Research Centre (CRCHUM), and his team of researchers at Massachusetts General Hospital, McMaster University, Jefferson University, University of Toronto, University of Western Ontario, James Cook University Hospital (UK) and McGill University, showed that thoracoscopic lobectomy – video-assisted thoracoscopic surgery (VATS) – combined with pulmonary artery sealing using an ultrasonic energy device reduced the risk of post-operative bleeding, complications and pain.
Unlike surgery with thoracotomy, which involves making a 25 cm incision in the patient’s chest and cutting the ribs, a VATS procedure requires small incisions. A miniature video camera is inserted through one of the incisions. In both types of surgical interventions, there is a risk of bleeding because the branches of the pulmonary artery are very thin, fragile and are attached directly to the heart.
“Thanks to this clinical trial conducted in Canadian, American and British hospitals, we have shown that it is possible to safely seal pulmonary blood vessels through ultrasonic sealing and effectively control possible bleeding during a VATS procedure,” explained Liberman, an associate professor of surgery at the University of Montréal.
Currently, only 15% of lobectomies around the world are performed by VATS, mainly because of the actual risks of major bleeding or surgeons’ perception of these risks.
“I truly hope that the results of our clinical trial will reassure surgeons about the technical feasibility and safety of this operation and will encourage them to adopt it. A large number of patients could benefit from it and would be on their feet faster, with less pain,” indicated Liberman.
After five years of pre-clinical research at the CRCHUM, trials conducted on animals, phase 1 and phase 2 clinical trials showing the safety of the surgical intervention, Liberman’s team has recently completed their large international phase 2 clinical trial launched in 2016.
It was able to evaluate the effectiveness of this new technique on 150 patients in eight hospitals across Canada, the US and the UK – 139 of them underwent a lobectomy, while the remaining 11 underwent a segmentectomy (removal of a small part of the lung).
A total of 424 pulmonary artery branches were sealed during the study: 181 using surgical staplers, 4 with endoscopic clips and 239 using the HARMONIC ACE® +7 Shears, designed by the company Ethicon (Johnson & Johnson). With a 3-millimetre jaw at its tip, this high-tech “pistol” allows a surgeon to seal blood vessels by delivering ultrasonic energy.
According to the World Health Organisation, lung cancer kills nearly 1.69m people around the world every year.
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.
Moishe Liberman, Eric Goudie, Chris Morse, Waël C Hanna, Nathaniel R Evans, Kazuhiro Yasufuku, Richard Malthaner, Joel Dunning, Edwin Lafontaine, Pasquale Ferraro, Cameron Wright, Hugh Auchincloss, Michael Lanuti, Jocelyne Martin, Harald C Ott, Henning A Gaissert, John Sampalis