Reducing Post-Operative Alveolo-Pleural Fistula by Applying PGA-Sheets (Neoveil) after Major Lung Resection: A Historical Case-Control Study.

Alveolo-pleural fistula remains a serious post-operative complication in lung cancer patients after surgery, which is associated with prolonged hospital stay and higher healthcare costs. The aim of this study is to evaluate the efficacy of a polyglycol acid (PGA)-sheet known as Neoveil in preventing post-operative air-leak in cases of detected intra-operative air-leak after lung resection. Between 11/2021 and 7/2022, a total of 329 non-small cell lung cancer (NSCLC) patients were surgically treated in two institutions. Major lung resections were performed in 251 cases. Among them, 44 patients with significant intra-operative air-leak at surgery were treated by reinforcing staple lines with Neoveil (study group). On the other hand, a historical group (selected by propensity score matched analysis) consisting of 44 lung cancer patients with significant intra-operative air leak treated by methods other than the application of sealant patches were considered as the control group. The presence of prolonged air-leak (primary endpoint), pleural drainage duration, hospital stay, and post-operative complication rates were evaluated. The results showed that prolonged air-leak (>5 days after surgery) was not observed in study group, while this event occurred in four patients (9.1%) in the control group. Additionally, a substantial reduction (despite not statistically significant) in the chest tube removal was noted in the study group with respect to the control group (3.5 vs. 4.5, p = 0.189). In addition, a significant decrease in hospital stay (4 vs. 6 days, p = 0.045) and a reduction in post-operative complications (2 vs. 10, p = 0.015) were observed in the study group when compared with the control group. Therefore, in cases associated with intra-operative air-leak after major lung resection, Neoveil was considered a safer and more effective aerostatic tool and represents a viable option during surgical procedures.

Management of pulmonary ground-glass opacities: a position paper from a panel of experts of the Italian Society of Thoracic Surgery (SICT).

OBJECTIVES: A significant gap in our knowledge of how to manage pulmonary ground-glass opacities (GGOs) still exists. Accordingly, there is a lack of consensus among clinicians on this topic. The Italian Society of Thoracic Surgery (Società Italiana di Chirurgia Toracica, SICT) promoted a national expert meeting to provide insightful guidance for clinical practice. Our goal was to publish herein the final consensus document from this conference. METHODS: The working panel of the PNR group (Pulmonary Nodules Recommendation Group, a branch of the SICT) together with 5 scientific supervisors (nominated by the SICT) identified a jury of expert thoracic surgeons who organized a multidisciplinary meeting to propose specific statements (n = 29); 73 participants discussed and voted on statements using a modified Delphi process (repeated iterations of anonymous voting over 2 rounds with electronic support) requiring 70% agreement to reach consensus on a statement. RESULTS: Consensus was reached on several critical points in GGO management, in particular on the definition of GGO, radiological and radiometabolic evaluation, indications for a non-surgical biopsy, GGO management based on radiological characteristics, surgical strategies (extension of pulmonary resection and lymphadenectomy) and radiological surveillance. A list of 29 statements was finally approved. CONCLUSIONS: The participants at this national expert meeting analysed this challenging topic and provided a list of suggestions for health institutions and physicians with practical indications for GGO management.

Current Practices in the Management of Pulmonary Ground-Glass Opacities: A Survey of SICT Members.

BACKGROUND: Several gray areas and controversies exist concerning the management of pulmonary ground-glass opacities (GGOs), and there is a lack of consensus among clinicians on this topic. One of the main aims of the Italian Society of Thoracic Surgery is to promote education and research, so we decided to perform a survey on this topic to estimate current trends in practice in a large sample of thoracic surgeons. METHODS: A total of 160 thoracic surgeons responded, namely, completed our questionnaire (response rate, 53%; 160 of 302). The survey was composed of 36 questions divided into six subsections: (1) demographic characteristics of the respondents; (2) terminology and taxonomy; (3) radiologic and radiometabolic evaluation; (4) diagnostic approach and indications for surgery; (5) surgical management; and (6) radiologic surveillance. RESULTS: We observed some divergence of opinion regarding the definition of mixed GGOs, the role of 18F fluorodeoxyglucose positron emission tomography and computed tomography scans, indications for nonsurgical biopsy, intraoperative techniques for localizing GGOs, indications for surgery, extension of lung resection and lymph node dissection according to the radiologic scenario, use of intraoperative frozen section analysis, and radiologic surveillance of pure GGOs. CONCLUSIONS: This topic warrants more investigation in the future. An upcoming consensus conference of Italian Society of Thoracic Surgery experts (also open to experts in other specialties) could provide updated indications for GGO management based on the literature, expert opinions, and the results of the present survey.

Preoperative Rehabilitation in Lung Cancer Patients: Yoga Approach.

Lung cancer is one of the leading causes of cancer death worldwide. Surgical removal remains the best option for most tumors of this type. Reduction of cigarette consumption in patients with lung cancer candidates for the surgery could limit the impact of tobacco on postsurgical outcomes. Breathing exercises appear to help combat cigarette cravings. Yoga exercise benefits have been studied in lung cancer survivors, rather than in the preoperative setting. In this study, we have recruited 32 active smokers affected by lung cancer and being candidates for pulmonary surgery. The patients were randomly assigned to two groups: one treated by standard breathing and the other treated by yoga breathing (YB). The groups were evaluated at times T0 (baseline) and T1 (after 7 days of treatment) to compare the effects of the two breathing treatments on pulmonary performance in a presurgery setting. Pulmonary and cardiocirculatory functions have been tested using a self-calibrating computerized spirometer and a portable pulse oximetry device. The findings demonstrate appreciable short-term improvement in lung function assessed by spirometry. We conclude that yoga breathing can be a beneficial preoperative support for thoracic surgery.

Experimental Robotic Pulmonary Lobectomy With the TELELAP/ALFX System in the Ovine Model.

A new robotic telesurgical device (TELELAP/ALFX) is used for the first time to execute an anatomical pulmonary resection (lobectomy) plus mediastinal lymph node dissection in the ovine model. This integrated operative system has 2 innovative peculiarities: (a) tactile perception (engineered to give the operator a tactile feedback similar to that experienced when handling thoracoscopy instruments) and (b) eye-tracking (immediate synchronization of the surgeon's eyes movements with that of the robotic camera). Herein, we report a lower right pulmonary lobectomy under complete robotic assistance (TELELAP/ALFX). Standard endoscopic staplers were used in all the major maneuvers (bronchial as well as vascular resections and fissural completion) introduced through a utility 4-cm-sized incision. The specimen was placed in an endoscopic retrieval bag and removed through a service minithoracotomy. With the limitations because of interspecies differences in anatomical landmarks, a mediastinal lymph nodal dissection was also completed. The operative time was acceptable (~180 minutes) with blood loss of 100 mL. In conclusion, according to this first all experimental experience we may deem the TELELAP/ALFX system completely apt to perform major anatomic pulmonary resections and the regulatory process to run trials in humans are under way.

A systems medicine clinical platform for understanding and managing non- communicable diseases.

Non-Communicable Diseases (NCDs) are among the most pressing global health problems of the twenty-first century. Their rising incidence and prevalence is linked to severe morbidity and mortality, and they are putting economic and managerial pressure on healthcare systems around the world. Moreover, NCDs are impeding healthy aging by negatively affecting the quality of life of a growing number of the global population. NCDs result from the interaction of various genetic, environmental and habitual factors, and cluster in complex ways, making the complex identification of resulting phenotypes not only difficult, but also a top research priority. The degree of complexity required to interpret large patient datasets generated by advanced high-throughput functional genomics assays has now increased to the point that novel computational biology approaches are essential to extract information that is relevant to the clinical decision-making process. Consequently, system-level models that interpret the interactions between extensive tissues, cellular and molecular measurements and clinical features are also being created to identify new disease phenotypes, so that disease definition and treatment are optimized, and novel therapeutic targets discovered. Likewise, Systems Medicine (SM) platforms applied to extensively-characterized patients provide a basis for more targeted clinical trials, and represent a promising tool to achieve better prevention and patient care, thereby promoting healthy aging globally. The present paper: (1) reviews the novel systems approaches to NCDs; (2) discusses how to move efficiently from Systems Biology to Systems Medicine; and (3) presents the scientific and clinical background of the San Raffaele Systems Medicine Platform.

Intercostal muscle flap to protect the bronchial stump in pediatric lobectomy for lung abscess.

Lung suppurative diseases in children are usually responsive to medical treatment or percutaneous drainage. Rarely, pulmonary resection is required for lung abscess in childhood, particularly in presence of co-morbidities. In these cases, a lobectomy is usually performed through an open thoracotomy, with a reported incidence of bronco-pleural fistula up to 9.1% of pediatric series. This consequence is mainly due to the inflammatory condition; however the lack of knowledge of pediatric and thoracic surgeons with this rare condition in childhood can also play a role. In adults with lung cancer, the buttressing of bronchial stump with the additional support of an intercostal muscle (ICM) flap has proved to prevent this complication, as well as to reduce post-operative pain. We report the first pediatric experience of ICM flap used in 2 immunocompetent children requiring lobectomy for suppurative lung conditions. Our preliminary experience confirms the feasibility of protecting the bronchial stump after lobectomy in children, especially in conditions at risk for bronco-pleural fistula development.

Adverse effects of fibrin sealants in thoracic surgery: the safety of a new fibrin sealant: multicentre, randomized, controlled, clinical trial.

OBJECTIVES: The safety of fibrin sealants (FS) has been questioned in the light of recent reports of adverse effects. We evaluated the safety of a new FS in a randomized controlled trial (RCT). METHODS: Multicentre, open-label Phase II/III RCT to evaluate the safety of the new FS. The trial was approved by the Ethic Committee of each three participating Centre. FS includes two components (component 1: fibrinogen; component 2: thrombin), each of them subjected to two viral inactivation procedures. Out of 200 screened patients, 185 eligible patients (49 females, 136 males), aged between 18 and 75 years, undergoing major thoracic surgery were randomized to receive FS (#91 patients) as an adjuvant for air leak control or no treatment (#94 patients, control group). Safety variables were: percentage of subjects with adverse events associated with the therapy; formation of antibodies against bovine aprotinin; vital signs (blood pressure, body temperature, heart and respiratory rate); laboratory parameters. RESULTS: Overall operative mortality was 3.2% (6/185), 1.1% in the FS group and 5.3% in the control group, respectively. Twenty patients (22%) had adverse events in the FS group and 22 (23.4%) in the control group. Atrial fibrillation (five patients in the FS group and four in the control group) and hyperpyrexia (five and seven patients, respectively, in the two groups) were the most common adverse events. No patient reported thromboembolic events (pulmonary embolism or deep vein thrombosis) during the in hospital stay or within 1 month from discharge. None of the adverse events was considered as treatment related. The formation of bovine aprotinin antibodies was reported in a total of 34 patients (37.4%) in the FS group and was not related to any adverse effect. CONCLUSIONS: The present RCT did not show any increased risk of adverse events, and of surgical complications, related to the use of the new FS.

Safety and effectiveness of a new fibrin pleural air leak sealant: a multicenter, controlled, prospective, parallel-group, randomized clinical trial.

BACKGROUND: This study evaluated the sealing capacity and safety of a new fibrin sealant (FS) to reduce alveolar air leaks (AALs) after pulmonary resections in a randomized controlled clinical trial conducted in 3 Italian centers. METHODS: The study randomized (1:1) 185 patients with an intraoperative AAL graded 1 to 3 according to the Macchiarini scale: 91 received FS and 94 had standard lung closure. The primary outcomes were the length of postoperative AAL duration and the mean time to chest drain removal. Other end points included the percentage of patients without AAL, the development of serum antibodies against bovine aprotinin, and any adverse event related to FS. Chest drains were removed when fluid output was 100 mL/day or less, with no air leak. RESULTS: The study groups were comparable with respect to demographic variables and surgical procedures. The FS group showed a statistically significant reduction in duration of postoperative AALs (9.52 vs 35.8 hours; p < 0.005) and in the percentage of patients with AALs at wound closure (81.11% vs 100%; p < 0.001); the difference in time to chest drain removal was not significant. Pleural empyema developed in 1 patient with FS treatment vs in 4 with standard treatment, and antibodies against bovine aprotinin were found in 34 of 91 FS-treated patients. CONCLUSIONS: The present study showed that the new FS is safe and effective in preventing AALs after lung resections and in shortening the duration of postoperative AALs.