Pulmonary Artery Sealing With an Ultrasonic Energy Device in Video-Assisted Thoracoscopic Surgery Lobectomy: An Animal Survival Study.

BACKGROUND: Pulmonary artery (PA) sealing in video-assisted thoracoscopic surgery (VATS) lobectomy is typically accomplished using vascular endostaplers. Endostaplers may be associated with iatrogenic PA branch injury, especially in short, small PA branches. We evaluated PA branch sealing with the HARMONIC ACE +7 (ACE) shears (Ethicon, Cincinnati, OH) in VATS lobectomy in a canine survival model. METHODS: Ten adult dogs underwent VATS lobectomy. Standard VATS lobectomy operative technique was used for the entire operation, except for PA branch sealing. The ACE was used for all PA branch sealing. Dogs were kept alive for 30 days. RESULTS: The 10 dogs underwent VATS right upper (n = 5) and right lower (n = 5) lobectomy. The ACE was used to seal 21 PA branches. No PA branch was divided with an endostapler. There were no intraoperative complications or conversions to thoracotomy. Mean in vivo PA diameter was 5.6 mm (range, 2 to 12 mm). One 10-mm PA branch had a partial seal failure immediately at the time of sealing. The device was reapplied on the stump, and the PA branch was successfully sealed. All dogs survived 30 days without hemothorax. Necropsy at 30 days did not reveal any signs of postoperative bleeding. Pathology of the sealed PA branches at 30 days revealed fibrosis, giant cell reaction, neovascularization, and thermal changes of the vessel wall. CONCLUSIONS: The use of the ACE for PA branch sealing in VATS lobectomy is safe and effective in an animal survival model. Human studies are needed to determine the clinical safety of ultrasonic PA branch sealing before widespread clinical use.

Endoscopic Mediastinal Staging in Lung Cancer Is Superior to "Gold Standard" Surgical Staging.

BACKGROUND: The objective was to evaluate whether endobronchial ultrasonography (EBUS) or endoscopic ultrasonography (EUS) staging techniques of the mediastinum for lung cancer can change the treatment plan compared with the "gold standard" of surgical staging. METHODS: Patients were retrospectively identified from a prospectively collected database. Endoscopic staging was compared with the "gold standard" cervical mediastinoscopy (CM). In cases where mediastinoscopy was not performed, EBUS/EUS was compared with "ideal" CM, a virtual procedure, which was assumed to have 100% rates of sensitivity and specificity. RESULTS: EBUS was performed in 324 patients (99%), EUS in 295 patients (90%), and CM in 101 patients (31%); 226 patients (69%) were assumed to have undergone a virtual ideal CM and a virtual surgical mediastinal staging; 108 positive biopsies (33.0%) with endosonography had sampling of targets that were out of the scope of CM. Distant metastatic disease was diagnosed by EBUS/EUS in 7 patients (2.1%); 22 patients (6.7%) had positive targets outside the reach of the CM or virtual CM. If the 14 patients who had positive stations 5, 6, 10, and 11 are excluded (accessible with anterior mediastinotomy or extended cervical mediastinoscopy), there were 6 patients (1.8%) in whom endosonography upstaged the patient over ideal surgical mediastinal staging. In 20 patients (6.1%), ultrasound-guided biopsy made the diagnoses, which changed the treatment plan over CM and ideal CM. CONCLUSIONS: Combined EBUS- and EUS-guided biopsies can access more targets, including lung and distant metastasis, and thus have the potential to upstage patients compared with mediastinoscopy and change the treatment plan.

Transtracheal thoracic natural orifice transluminal endoscopic surgery (NOTES) in a swine model.

BACKGROUND: Natural orifice transluminal endoscopic surgery (NOTES) has the potential to be the final frontier in minimally invasive procedures in thoracic surgery. In order for thoracic pleural NOTES to 1 day be ready for clinical trials, each step of the procedure must be independently evaluated for both safety and efficacy. The aim of this study was to evaluate the trachea as a portal of entry for thoracic NOTES. METHODS: Eight 40-kg swine underwent right thoracic pleuroscopy in a survival model. In order to avoid inadvertent injury to the superior vena cava, endobronchial ultrasound was employed to select the location of airway incision. A 7-mm linear incision was then performed at the chosen location using an endoscopic electrocautery needle knife through a therapeutic flexible videobronchoscope. The mediastinal fat and parietal pleura were then dissected with electrocautery, and complete right pleuroscopy was performed. The tracheal and mediastinal portal of entry were then sealed with 1-2 cc of fibrin sealant. The pigs were kept alive for 21 days postoperatively. Postmortem diagnostic bronchoscopy was performed to assess tracheal healing. All tracheal specimens underwent histologic examination for healing and signs of mediastinal infection. RESULTS: Thoracic NOTES procedures on all eight pigs were successful. There were no intraoperative complications except for one minor bleeding episode within the mediastinal dissection site which stopped spontaneously. Two pigs died from severe laryngospasm in the early postoperative period. Six pigs survived for 21 days post-procedure and experienced uneventful postoperative courses. Postmortem examination demonstrated complete tracheal healing with appropriate scarring in all pigs. CONCLUSIONS: The trachea appears to be a safe port of entry for thoracic NOTES procedures in a swine model. Smaller tracheal incisions followed by balloon dilatation are associated with less postoperative morbidity and mortality. Tracheal incisions sealed with fibrin sealant healed rapidly and without signs of mediastinal infection. This procedure represents a work in progress and is not yet ready for human trials.

Pulmonary Artery Sealing Using the HARMONIC ACE+ Shears for Video-Assisted Thoracoscopic Surgery Lobectomy.

BACKGROUND: The standard technique for pulmonary arterial (PA) branch sealing in video-assisted thoracoscopic surgery lobectomy consists of vascular endostaplers. We evaluated the immediate efficacy of an ultrasonic energy vessel-sealing device for sealing PA branches and compared it with the gold standard (endostapler) in an ex vivo model. METHODS: This was a prospective cohort study. Immediately after anatomical lung resection, PA vessel sealing was achieved using the HARMONIC ACE+ Shears (ACE; Ethicon, Cincinnati, OH) sealing device or a vascular endostapler (VES) in a 3:1 ratio based on vessel diameter. The vessel was slowly pressurized, and the bursting pressure was recorded. RESULTS: A total of 137 PA branches were sealed in specimens from 43 patients, of which 90 vessels were sealed with ACE and 47 were sealed with VES. The mean PA branch diameter was 6.0 mm (range, 1.7 mm to 24.0 mm; standard deviation, 3.1 mm Hg). The mean bursting pressure was 333.0 mm Hg (range, 84.0 mm Hg to 1415.1 mm Hg; standard deviation, 231.4 mm Hg) in the ACE group and 114.2 mm Hg (range, 0 mm Hg to 840.0 mm Hg; standard deviation, 124.7) in the VES group (p < 0.001). There were no complete sealing failures in the ACE group. Electron microscopy of ACE-sealed PA vessels demonstrated adventitial sealing with partial preservation of the collagen bundles and media with a sealed matrix of melted collagen. CONCLUSIONS: PA branches sealed using the HARMONIC ACE+ in a simulated ex vivo model were able to sustain high intraluminal pressures. ACE-sealed vessels burst at mean bursting pressures equal to or greater than the VES-stapled vessels.

Pilot study of pulmonary arterial branch sealing using energy devices in an ex vivo model.

OBJECTIVE: Vascular endostaplers are bulky and can be dangerous when dividing small pulmonary arterial (PA) branch vessels during video-assisted thoracoscopic lobectomy. We aimed to evaluate and compare the immediate efficacy of modern energy sealing devices in an ex vivo PA sealing model. METHODS: Patients undergoing anatomical lung resection or lung transplantation were recruited for a prospective cohort pilot study. Four devices were evaluated: Harmonic Ace (Ethicon, Cincinnati, Ohio), Thunderbeat (Olympus, Tokyo, Japan), LigaSure (Covidien, Boulder, Colo), and Enseal (Ethicon; Cincinnati, Ohio). After anatomical lung resection, the PA branches were dissected in vitro. Sealing was then performed with 1 of the sealing devices, the vessel was slowly pressurized, and the bursting pressure was recorded. RESULTS: Forty-nine PA branches were sealed in 14 patients. The mean PA branch diameter was 7.4 mm (1.8-14.5 mm). Ten patients had normal PA pressure and 3 had PA hypertension. The mean bursting pressure in each was as follows: Harmonic Ace group, 415.5 mm Hg (137.1-1388.4 mm Hg), Thunderbeat group, 875 mm Hg (237.1-2871.3 mm Hg); LigaSure group, 214.7 mm Hg (0-579.6 mm Hg); Enseal group, 133.7 mm Hg (0-315.38 mm Hg). There were 2 complete sealing failures: LigaSure (diameter 6.78 mm) and Enseal (diameter 8.3 mm). CONCLUSIONS: In this pilot study to examine energy sealing of PA branches in a simulated ex vivo model, vascular sealing using energy was effective and was able to sustain high intraluminal bursting pressures. Further research is needed to determine the in vivo and long-term safety of PA branch energy sealing.

Preoperative assessment of chest wall invasion in non-small cell lung cancer using surgeon-performed ultrasound.

BACKGROUND: Chest wall invasion in operable lung cancer upgrades the stage and can affect operative planning. Diagnosing chest wall invasion preoperatively is important in patient consent, in the choice of operative incision placement, and can be helpful in choosing an operative approach (open vs thoracoscopic). The objectives of this study were to determine the diagnostic accuracy of preoperative, surgeon-performed ultrasound (US) in assessing tumoral chest wall invasion (T3) in non-small cell lung cancer (NSCLC) patients and to compare its accuracy vs preoperative computed tomography (CT). METHODS: This study was a prospective clinical trial (ClinicalTrials.gov: NCT01206894) that prospectively enrolled patients between September 2010 and January 2013. Eligible patients included those with NSCLC abutting the parietal pleura or invading the chest wall on preoperative CT scan of the chest and who were planned for surgical resection. Criteria for chest wall invasion on US included (1) disruption of the parietal pleura, (2) invasion of the ribs, or (3) impairment of pleural movement with respiration. The US chest wall examination was performed by the thoracic surgical team immediately before the surgical intervention. Sensitivity and specificity for CT scan and US in assessing chest wall invasion were calculated using definitive chest wall invasion on final pathologic analysis as the gold standard for chest wall invasion. RESULTS: During a 28-month period, 28 patients (15 men and 13 women) patients were prospectively enrolled. Mean age was 62 ± 11 years, and mean body mass index was 25.3 ± 4.5 kg/m(2). The average time for surgeon-performed US assessment looking for chest wall invasion was 5.3 ± 5 minutes. The sensitivity of US in evaluating chest wall invasion was 90.9% and the specificity was 85.7%. CT scan was associated with a sensitivity of 61.5% and a specificity of 84.6%. The positive and negative predictive values of surgeon-performed US for tumoral chest wall invasion were 83.3% and 92.3%, respectively, compared with 80% and 68.8% for CT scan. CONCLUSIONS: Surgeon-performed preoperative chest wall US can reliably diagnose tumoral chest wall invasion in patients with NSCLC. CT scan has poor sensitivity in predicting chest wall invasion preoperatively. Surgeon-performed US can be considered as a complementary adjunct to preoperative imaging in patients with pulmonary lesions abutting the chest wall to improve preoperative diagnosis, staging, and operative planning.

Pleural ultrasound as an adjunct to physical examination in the preoperative evaluation of lung cancer patients.

OBJECTIVES: Preoperative evaluation of patients with suspected or confirmed lung cancer consists of clinical and radiological staging. Malignant pleural effusion is a poor prognosticator in non-small-cell lung cancer. Pleural ultrasound (PU) allows for the assessment of pleural effusion, providing real-time guidance for its aspiration and cytological analysis. Pleural Ultrasonography in Lung Cancer (PULC) as an adjunct to physical examination has the potential to improve preoperative staging of non-small-cell lung cancer during first surgical encounter by allowing the evaluation of previously unassessed pleural effusion. METHODS: This study consisted of a prospective trial of surgeon-performed PU in the preoperative evaluation of lung cancer patients. All patients evaluated in the thoracic surgery clinic with the new or presumed diagnosis of lung cancer were eligible. A portable ultrasound machine was used to evaluate pleural fluid in the bilateral costophrenic sulci with pleural fluid aspiration for cytological analysis. RESULTS: Forty-five patients were prospectively enrolled over a 3-month period. Thirteen patients had ultrasound evidence of a pleural effusion, of which 3 were significant enough for aspiration. Cytological analysis of these effusions yielded malignant cells in 1 patient. Positive PULC evaluation led to a change in clinical staging (M0 to M1a) in 10 patients and a change in pathological staging (pleural fluid cytology positive) in 1 patient. The time required for PULC examination was 15 ± 7 min. There were no complications related to the procedures. CONCLUSIONS: Preoperative pleural ultrasonography is a rapid and effective way to improve precision of staging in patients with lung cancer. More precise staging may allow for more appropriate testing, patient prognostication and operative planning.

Initial experience with a new technique of endoscopic and ultrasonographic access for biopsy of para-aortic (station 6) mediastinal lymph nodes without traversing the aorta.

OBJECTIVES: All lymph node stations but the para-aortic are accessible by a combination of endoscopic ultrasound and endobronchial ultrasound. We recently described an echographic-endoscopic technique for the biopsy of para-aortic (station 6) lymph nodes without traversing the thoracic aorta. This study reviewed our initial experience with this new technique. METHODS: This first-in-human evaluation of the biopsy of station 6 mediastinal lymph nodes with curvilinear endoscopic ultrasound without arterial puncture used a retrospective case series design to study 12 consecutive patients who underwent this new technique. Station 6 lymph nodes were approached with a long fine needle aspiration approach (6-8 cm) through the proximal esophagus. The needle was passed through the esophagus into the mediastinum just medial to the left subclavian artery. It was then directed toward the para-aortic location (6-8 cm trajectory) to reach and enter the para-aortic lymph nodes without piercing the aorta or great vessels. RESULTS: Successful cytologic diagnoses of station 6 lymph nodes were obtained in all cases (lymphocytes in all samples). No morbidity resulted from the procedure, nor was any observed at 30 days after the procedure. Patient anatomy may preclude safe access in certain situations. CONCLUSIONS: Endoscopic ultrasound access of para-aortic (station 6) lymph nodes allows complete, minimally invasive mediastinal lymph node staging and diagnosis without traversal of the aorta. This technique, the final piece of the puzzle required for complete staging of the mediastinum with nonsurgical endoscopic techniques, is reproducible and safe.

Thoracoscopic localization of intraparenchymal pulmonary nodules using direct intracavitary thoracoscopic ultrasonography prevents conversion of VATS procedures to thoracotomy in selected patients.

OBJECTIVES: To investigate the feasibility, accuracy, and effect on conversion rates of intracavitary video-assisted thoracoscopic surgery ultrasonography (VATS-US) for localization of difficult to visualize pulmonary nodules. METHODS: The study consisted of a prospective cohort of VATS-US for localization of intraparenchymal peripheral pulmonary nodules. Patients with pulmonary nodules not touching the visceral pleura on the computed tomography scan, who were scheduled for VATS wedge resection, were prospectively enrolled. The lobe of interest was examined: visually, using finger palpation when possible, and using the instrument sliding method. The nodule was then sought using a sterile ultrasound transducer. The primary outcome measure was the prevention of conversion to thoracotomy or lobectomy secondary to positive VATS-US findings in patients with nodules that were not identifiable using standard VATS techniques. RESULTS: Four different surgeons performed 45 individual VATS-US procedures during a 13-month period. Intracavitary VATS-US was able to detect 43 of 46 nodules. The sensitivity of VATS-US was 93%, and the positive predictive value was 100%. The lung nodules were visualized by thoracoscopic lung examination in 12 cases (27%), palpable by finger in 18 cases (40%), and palpable using the instrument sliding technique in 17 cases (38%). In 20 cases, lung nodules were not identifiable using any of the traditional techniques and were identified only with VATS-US. VATS-US, therefore, prevented conversion to thoracotomy or lobectomy without tissue diagnosis in 43% (20/46) of cases. CONCLUSIONS: Intracavitary VATS-US is a real-time, feasible, reliable, and effective method of localization of intraparenchymal pulmonary nodules during selected VATS wedge resection procedures and can decrease the conversion rates to thoracotomy or lobectomy.

Cervical video-assisted thoracoscopic surgery using a flexible endoscope for bilateral thoracoscopy.

Video-assisted thoracoscopic surgery (VATS) has become the standard of care for pleural evaluation, drainage, and pleurodesis. The major limitations to standard VATS techniques include intercostal pain and the unilateral nature of the procedure. We report on a cervical VATS approach for bilateral thoracoscopy, pleural biopsy, and talc pleurodesis using a flexible video endoscope without any intercostal incision. A 64-year old male with peritoneal carcinomatosis was noted to have significant bilateral pleural effusions. A cervical video-assisted thoracoscopic surgery (C-VATS) procedure was performed through a 2-cm cervical incision using a sterile flexible gastroscope. Bilateral thoracoscopy, pleural drainage, pleural biopsies, lung biopsy, and talc pleurodesis were performed. No thoracic intercostal incisions were performed. Total operative time was 48 minutes. The procedure was successful and the recovery was uneventful. The patient was discharged 4 days after the procedure. C-VATS is an extremely minimally invasive procedure. It avoids intercostal incisions and allows for bilateral pleural procedures through a single small cervical incision.

Prospective trial evaluating sonography after thoracic surgery in postoperative care and decision making.

OBJECTIVE: Following thoracic surgery, daily chest X-rays (CXRs) are performed to assess patient evolution and to make decisions regarding chest tube removal and patient discharge. Sonography after thoracic surgery (SATS) has the potential to be an effective, convenient, inexpensive and easy to learn tool in the post-operative management of thoracic surgery patients. We hypothesized that SATS could alleviate the need for repetitive CXRs, thus reducing the related risks, costs and inconvenience. METHODS: This study consisted of a prospective cohort trial. All patients scheduled to undergo thoracic surgery at a single academic medical centre were eligible. Post-operative bedside pleural ultrasound was performed whenever a CXR was ordered by the treating team. Investigators specifically assessed patients with the goals of identifying pleural effusions and pneumothoraces. Study investigators were blinded to CXR results. SATS findings were compared with CXRs, which were considered the gold standard in routine post-operative pleural space evaluation. RESULTS: One hundred and twenty patients were prospectively enrolled over a 5.5-month period. Three hundred and fifty-two ultrasound examinations were performed (mean = 3.0 ± 2.4 exams per patient). The time interval between the ultrasound and the comparative CXR was 166 ± 149 min. The mean time required to perform SATS was 11 ± 6 min per exam. In the detection of pleural effusion, SATS yielded a sensitivity of 83.1% and a specificity of 59.3%. In the detection of pneumothoraces, a sensitivity of 21.2% and a specificity of 94.7% were obtained. CONCLUSIONS: Post-operative ultrasound may alleviate the need to perform routine CXR in patients with a previously ruled out pneumothorax. SATS used selectively may be able to reduce the number of routine CXRs performed; however, it does not have high enough accuracy to replace CXRs.