Lobar or Sublobar Resection for Peripheral Stage IA Non-Small-Cell Lung Cancer.

BACKGROUND: The increased detection of small-sized peripheral non-small-cell lung cancer (NSCLC) has renewed interest in sublobar resection in lieu of lobectomy. METHODS: We conducted a multicenter, noninferiority, phase 3 trial in which patients with NSCLC clinically staged as T1aN0 (tumor size, ≤2 cm) were randomly assigned to undergo sublobar resection or lobar resection after intraoperative confirmation of node-negative disease. The primary end point was disease-free survival, defined as the time between randomization and disease recurrence or death from any cause. Secondary end points were overall survival, locoregional and systemic recurrence, and pulmonary functions. RESULTS: From June 2007 through March 2017, a total of 697 patients were assigned to undergo sublobar resection (340 patients) or lobar resection (357 patients). After a median follow-up of 7 years, sublobar resection was noninferior to lobar resection for disease-free survival (hazard ratio for disease recurrence or death, 1.01; 90% confidence interval [CI], 0.83 to 1.24). In addition, overall survival after sublobar resection was similar to that after lobar resection (hazard ratio for death, 0.95; 95% CI, 0.72 to 1.26). The 5-year disease-free survival was 63.6% (95% CI, 57.9 to 68.8) after sublobar resection and 64.1% (95% CI, 58.5 to 69.0) after lobar resection. The 5-year overall survival was 80.3% (95% CI, 75.5 to 84.3) after sublobar resection and 78.9% (95% CI, 74.1 to 82.9) after lobar resection. No substantial difference was seen between the two groups in the incidence of locoregional or distant recurrence. At 6 months postoperatively, a between-group difference of 2 percentage points was measured in the median percentage of predicted forced expiratory volume in 1 second, favoring the sublobar-resection group. CONCLUSIONS: In patients with peripheral NSCLC with a tumor size of 2 cm or less and pathologically confirmed node-negative disease in the hilar and mediastinal lymph nodes, sublobar resection was not inferior to lobectomy with respect to disease-free survival. Overall survival was similar with the two procedures. (Funded by the National Cancer Institute and others; CALGB 140503 ClinicalTrials.gov number, NCT00499330.).

Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer.

BACKGROUND: Among patients with resectable early-stage non-small-cell lung cancer (NSCLC), a perioperative approach that includes both neoadjuvant and adjuvant immune checkpoint inhibition may provide benefit beyond either approach alone. METHODS: We conducted a randomized, double-blind, phase 3 trial to evaluate perioperative pembrolizumab in patients with early-stage NSCLC. Participants with resectable stage II, IIIA, or IIIB (N2 stage) NSCLC were assigned in a 1:1 ratio to receive neoadjuvant pembrolizumab (200 mg) or placebo once every 3 weeks, each of which was given with cisplatin-based chemotherapy for 4 cycles, followed by surgery and adjuvant pembrolizumab (200 mg) or placebo once every 3 weeks for up to 13 cycles. The dual primary end points were event-free survival (the time from randomization to the first occurrence of local progression that precluded the planned surgery, unresectable tumor, progression or recurrence, or death) and overall survival. Secondary end points included major pathological response, pathological complete response, and safety. RESULTS: A total of 397 participants were assigned to the pembrolizumab group, and 400 to the placebo group. At the prespecified first interim analysis, the median follow-up was 25.2 months. Event-free survival at 24 months was 62.4% in the pembrolizumab group and 40.6% in the placebo group (hazard ratio for progression, recurrence, or death, 0.58; 95% confidence interval [CI], 0.46 to 0.72; P<0.001). The estimated 24-month overall survival was 80.9% in the pembrolizumab group and 77.6% in the placebo group (P = 0.02, which did not meet the significance criterion). A major pathological response occurred in 30.2% of the participants in the pembrolizumab group and in 11.0% of those in the placebo group (difference, 19.2 percentage points; 95% CI, 13.9 to 24.7; P<0.0001; threshold, P = 0.0001), and a pathological complete response occurred in 18.1% and 4.0%, respectively (difference, 14.2 percentage points; 95% CI, 10.1 to 18.7; P<0.0001; threshold, P = 0.0001). Across all treatment phases, 44.9% of the participants in the pembrolizumab group and 37.3% of those in the placebo group had treatment-related adverse events of grade 3 or higher, including 1.0% and 0.8%, respectively, who had grade 5 events. CONCLUSIONS: Among patients with resectable, early-stage NSCLC, neoadjuvant pembrolizumab plus chemotherapy followed by resection and adjuvant pembrolizumab significantly improved event-free survival, major pathological response, and pathological complete response as compared with neoadjuvant chemotherapy alone followed by surgery. Overall survival did not differ significantly between the groups in this analysis. (Funded by Merck Sharp and Dohme; KEYNOTE-671 ClinicalTrials.gov number, NCT03425643.).

Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer.

BACKGROUND: Neoadjuvant or adjuvant chemotherapy confers a modest benefit over surgery alone for resectable non-small-cell lung cancer (NSCLC). In early-phase trials, nivolumab-based neoadjuvant regimens have shown promising clinical activity; however, data from phase 3 trials are needed to confirm these findings. METHODS: In this open-label, phase 3 trial, we randomly assigned patients with stage IB to IIIA resectable NSCLC to receive nivolumab plus platinum-based chemotherapy or platinum-based chemotherapy alone, followed by resection. The primary end points were event-free survival and pathological complete response (0% viable tumor in resected lung and lymph nodes), both evaluated by blinded independent review. Overall survival was a key secondary end point. Safety was assessed in all treated patients. RESULTS: The median event-free survival was 31.6 months (95% confidence interval [CI], 30.2 to not reached) with nivolumab plus chemotherapy and 20.8 months (95% CI, 14.0 to 26.7) with chemotherapy alone (hazard ratio for disease progression, disease recurrence, or death, 0.63; 97.38% CI, 0.43 to 0.91; P = 0.005). The percentage of patients with a pathological complete response was 24.0% (95% CI, 18.0 to 31.0) and 2.2% (95% CI, 0.6 to 5.6), respectively (odds ratio, 13.94; 99% CI, 3.49 to 55.75; P<0.001). Results for event-free survival and pathological complete response across most subgroups favored nivolumab plus chemotherapy over chemotherapy alone. At the first prespecified interim analysis, the hazard ratio for death was 0.57 (99.67% CI, 0.30 to 1.07) and did not meet the criterion for significance. Of the patients who underwent randomization, 83.2% of those in the nivolumab-plus-chemotherapy group and 75.4% of those in the chemotherapy-alone group underwent surgery. Grade 3 or 4 treatment-related adverse events occurred in 33.5% of the patients in the nivolumab-plus-chemotherapy group and in 36.9% of those in the chemotherapy-alone group. CONCLUSIONS: In patients with resectable NSCLC, neoadjuvant nivolumab plus chemotherapy resulted in significantly longer event-free survival and a higher percentage of patients with a pathological complete response than chemotherapy alone. The addition of nivolumab to neoadjuvant chemotherapy did not increase the incidence of adverse events or impede the feasibility of surgery. (Funded by Bristol Myers Squibb; CheckMate 816 ClinicalTrials.gov number, NCT02998528.).

Lobar or sublobar resection of peripheral stage I non-small cell lung cancer.

PURPOSE OF REVIEW: We aim to highlight two recent clinical trials that have altered the approach of the management of stage I nonsmall cell lung cancer. RECENT FINDINGS: The JCOG 0802 and CALGB 140503 trials demonstrated that sublobar resection is noninferior to lobectomy for overall and disease-free survival in patients with stage I nonsmall cell lung cancer. SUMMARY: Since 1962, lobectomy has been deemed the gold standard treatment for operable lung cancer. However, two recent clinical trials have demonstrated that, for select patients, sublobar resection is oncologically noninferior; results, which are leading us into a new era for the surgical management of lung cancer. Notwithstanding the progress made by these studies and the opportunities that have been put forth, questions remain. This review aims at reviewing the results of both trials and to discuss future perspectives for the surgical treatment of lung cancer.

Transbronchial Lung Cryobiopsies, Transbronchial Forceps Lung Biopsies, and Surgical Lung Biopsies in Mechanically Ventilated Patients with Acute Hypoxemic Respiratory Failure: A Retrospective Cohort Study.

IMPORTANCE: Lung biopsies are sometimes performed in mechanically ventilated patients with acute hypoxemic respiratory failure (AHRF) of unknown etiology to guide patient management. While surgical lung biopsies (SLB) offer high diagnostic rates, they may also cause significant complications. Transbronchial forceps lung biopsies (TBLB) are less invasive but often produce non-contributive specimens. Transbronchial lung cryobiopsies (TBLC) yield specimens of potentially better quality than TBLB, but due to their novel implementation in the intensive care unit (ICU), their accuracy and safety are still unclear. OBJECTIVES: Our main objective was to evaluate the risk of adverse events in patients with AHRF following the three biopsy techniques. Our secondary objectives were to assess the diagnostic yield and associated modifications of patient management of each technique. DESIGN, SETTINGS AND PARTICIPANTS: We conducted a retrospective cohort study comparing TBLC, TBLB, and SLB in mechanically ventilated patients with AHRF. MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of patients with at least one complication, and secondary outcomes included complication rates, diagnostic yields, treatment modifications, and mortality. RESULTS: Of the 26 patients who underwent lung biopsies from 2018 to 2022, all TBLC and SLB patients and 60% of TBLB patients had at least one complication. TBLC patients had higher unadjusted numbers of total and severe complications, but also worse Sequential Organ Failure Assessment scores and P/F ratios. A total of 25 biopsies (25/26, 96%) provided histopathological diagnoses, 88% (22/25) of which contributed to patient management. ICU mortality was high for all modalities (63% for TBLC, 60% for TBLB and 50% for SLB). CONCLUSIONS AND RELEVANCE: All biopsy methods had high diagnostic yields and the great majority contributed to patient management; however, complication rates were elevated. Further research is needed to determine which patients may benefit from lung biopsies and to determine the best biopsy modality.

Transbronchial Lung Cryobiopsy and Surgical Lung Biopsy: A Prospective Multi-Centre Agreement Clinical Trial (CAN-ICE).

Rationale: Transbronchial cryobiopsy (TBCB) for the diagnosis of interstitial lung disease (ILD) has shown promising results, but prospective studies with matched surgical lung biopsy (SLB) have yielded conflicting results. Objectives: We aimed to assess within- and between-center diagnostic agreement between TBCB and SLB at both the histopathologic and multidisciplinary discussion (MDD) levels in patients with diffuse ILD. Methods: In a multicenter prospective study, we performed matched TBCB and SLB in patients referred for SLB. After a blinded review by three pulmonary pathologists, all cases were reviewed by three independent ILD teams in an MDD. MDD was performed first with TBCB, then with SLB in a second session. Within-center and between-center diagnostic agreement was evaluated using percentages and correlation coefficients. Measurements and Main Results: Twenty patients were recruited and underwent contemporaneous TBCB and SLB. Within-center diagnostic agreement between TBCB-MDD and SLB-MDD was reached in 37 of the 60 (61.7%) paired observations, resulting in a Cohen's κ value of 0.46 (95% confidence interval [CI], 0.29-0.63). Diagnostic agreement increased among high-confidence or definitive diagnoses on TBCB-MDD (21 of 29 [72.4%]), but not significantly, and was more likely among cases with SLB-MDD diagnoses of idiopathic pulmonary fibrosis than fibrotic hypersensitivity pneumonitis (13 of 16 [81.2%] vs. 16 of 31 [51.6%]; P = 0.047). Between-center agreement for cases was markedly higher for SLB-MDD (κ = 0.71 [95% CI, 0.52-0.89]) than TBCB-MDD (κ = 0.29 [95% CI, 0.09-0.49]). Conclusions: This study demonstrated moderate TBCB-MDD and SLB-MDD diagnostic agreement for ILD, while between-center agreement was fair for TBCB-MDD and substantial for SLB-MDD. Clinical trial registered with www.clinicaltrials.gov (NCT02235779).

Plain language summary of the CheckMate 816 study results: nivolumab plus chemotherapy given before surgery for non-small-cell lung cancer.

WHAT IS THIS SUMMARY ABOUT?: In this article, we summarize results from the ongoing phase 3 CheckMate 816 clinical study that were published in The New England Journal of Medicine in 2022. The goal of CheckMate 816 was to find out if nivolumab, an immunotherapy that activates a person's immune system (the body's natural defense system) to fight cancer, plus chemotherapy works better than chemotherapy alone when given before surgery in people with non-small-cell lung cancer (NSCLC) that can be removed surgically (resectable NSCLC). WHAT HAPPENED IN THE STUDY?: Adults who had not previously taken medications to treat NSCLC and whose cancer could be removed with surgery were included in CheckMate 816. During this study, a computer randomly assigned the treatment each person would receive before surgery for NSCLC. In total, 179 people were randomly assigned to receive nivolumab plus chemotherapy, and 179 people were randomly assigned to receive chemotherapy alone. The researchers assessed whether people who received nivolumab plus chemotherapy lived longer without the cancer geting worse or coming back and whether there were any cancer cells left in the tumor and lymph nodes removed by surgery. The researchers also assessed how adding nivolumab to chemotherapy affected the timing and outcomes of surgery and whether the combination of these drugs was safe. WHAT WERE THE RESULTS?: Researchers found that people who took nivolumab plus chemotherapy lived longer without the cancer getting worse or coming back compared with those who took chemotherapy alone. More people in the nivolumab plus chemotherapy group had no cancer cells left in the tumor and lymph nodes removed by surgery. Most people went on to have surgery in both treatment groups; the people who took nivolumab plus chemotherapy instead of chemotherapy alone had less extensive surgeries and were more likely to have good outcomes after less extensive surgeries. Adding nivolumab to chemotherapy did not lead to an increase in the rate of side effects compared with chemotherapy alone, and side effects were generally mild and manageable. WHAT DO THE RESULTS OF THE STUDY MEAN?: Results from CheckMate 816 support the benefit of using nivolumab plus chemotherapy before surgery for people with resectable NSCLC. Clinical Trial Registration: NCT02998528 (ClinicalTrials.gov).

EBUS versus EUS-B for diagnosing sarcoidosis: The International Sarcoidosis Assessment (ISA) randomized clinical trial.

BACKGROUND AND OBJECTIVE: Endosonography with intrathoracic nodal sampling is proposed as the single test with the highest granuloma detection rate in suspected sarcoidosis stage I/II. However, most studies have been performed in limited geographical regions. Studies suggest that oesophageal endosonographic nodal sampling has higher diagnostic yield than endobronchial endosonographic nodal sampling, but a head-to-head comparison of both routes has never been performed. METHODS: Global (14 hospitals, nine countries, four continents) randomized clinical trial was conducted in consecutive patients with suspected sarcoidosis stage I/II presenting between May 2015 and August 2017. Using an endobronchial ultrasound (EBUS) scope, patients were randomized to EBUS or endoscopic ultrasound (EUS)-B-guided nodal sampling, and to 22- or 25-G ProCore needle aspiration (2 × 2 factorial design). Granuloma detection rate was the primary study endpoint. Final diagnosis was based on cytology/pathology outcomes and clinical/radiological follow-up at 6 months. RESULTS: A total of 358 patients were randomized: 185 patients to EBUS-transbronchial needle aspiration (EBUS-TBNA) and 173 to EUS-B-fine-needle aspiration (FNA). Final diagnosis was sarcoidosis in 306 patients (86%). Granuloma detection rate was 70% (130/185; 95% CI, 63-76) for EBUS-TBNA and 68% (118/173; 95% CI, 61-75) for EUS-B-FNA (p = 0.67). Sensitivity for diagnosing sarcoidosis was 78% (129/165; 95% CI, 71-84) for EBUS-TBNA and 82% (115/141; 95% CI, 74-87) for EUS-B-FNA (p = 0.46). There was no significant difference between the two needle types in granuloma detection rate or sensitivity. CONCLUSION: Granuloma detection rate of mediastinal/hilar nodes by endosonography in patients with suspected sarcoidosis stage I/II is high and similar for EBUS and EUS-B. These findings imply that both diagnostic tests can be safely and universally used in suspected sarcoidosis patients.

Multi-institutional retrospective analysis of adverse events following rigid tracheobronchoscopy.

BACKGROUND AND OBJECTIVE: Rigid tracheobronchoscopy (RTB) has seen an increasing interest over the last decades with the development of the field of IPM but no benchmark exists for complication rates in RTB. We aimed to establish benchmarks for complication rates in RTB. METHODS: A multicentric retrospective analysis of RTB performed between 2009 and 2015 in eight participating centres was performed. RESULTS: A total of 1546 RTB were performed over the study period. One hundred and thirty-one non-lethal complications occurred in 103 procedures (6.7%, 95% CI: 5.5-8.0%). The periprocedural mortality rate was 1.2% (95% CI: 0.6-1.8%). The 30-day mortality rate was 5.6% (95% CI: 4.5-6.8%). Complication rate increases further when procedures were performed in an emergency setting. Procedures in patients with MAO are associated with a higher 30-day mortality (8.1% vs 2.7%, P < 0.01) and a different complication profile when compared to procedures performed for BAS. CONCLUSION: RTB is associated with a 6.7% non-lethal complication rate, a 1.2% periprocedural mortality rate and a 5.6% 30-day mortality in a large multicentre cohort of patients with benign and malignant airway disease.

Enhanced recovery after video-assisted thoracoscopic surgery lobectomy: a prospective, historically controlled, propensity-matched clinical study.

Background: Enhanced recovery pathways or fast-tracking following surgery can decrease the rate of postoperative complications and hospital length of stay. The objectives of this study were to implement an enhanced recovery after surgery (ERAS) pathway for patients undergoing a video-assisted thoracoscopic surgery (VATS) lobectomy, to assess the safety and efficiency of this protocol by measuring associated postoperative outcomes, and to compare the outcomes for patients in the ERAS group with the outcomes for patients in a propensity-matched control group. Methods: The study was a prospective clinical trial. Patients who were scheduled to undergo VATS lobectomy at the Centre hospitalier de l'Université de Montréal in Montréal, Quebec, Canada, were enrolled between November 2015 and October 2016. The ERAS pathway was used for all enrolled patients. The primary outcome was the number and severity of complications measured by the Comprehensive Complication Index. Secondary outcomes included length of stay, readmission and recovery. Recovery of patients was measured using EQ-5D-5L preoperatively and at 1 week, 1 month and 4 months after surgery. Prospectively enrolled patients were propensity matched to historical controls. Results: Ninety-eight patients (36 men and 62 women) in the ERAS group and 98 patients in the control group (29 men and 69 women) were included in the analysis. The mean age was 65.2 ± 9.3 years, the mean body mass index (BMI) was 26.9 ± 5.9 kg/m2 and the median Charlson Comorbidity Index score was 2 (interquartile range [IQR] 2-3) in the ERAS group. In the control group, the mean age was 66.2 ± 9.4 years, the mean BMI was 27.4 ± 5.6 kg/m2 and the median Charlson Comorbidity Index score was 3 (IQR 2-3). A total of 23 patients (23.4%) in the ERAS group and 28 (28.6%) in the control group experienced 1 or more postoperative complications. The mean Comprehensive Complication Index score was 7.4 ± 16.8 in the ERAS group compared with 8.0 ± 14.3 in the control group (p = 0.79). The median postoperative length of stay was 3 days in the ERAS group and 5 days in the control group (p < 0.001). Five patients in the ERAS group and 4 patients in the control group were readmitted. The protocol adherence rate was 64.3%. Conclusion: It is feasible to implement an enhanced recovery protocol after VATS lobectomy. Although the pathway is still early in its development in Canada, implementation of an ERAS pathway after VATS lobectomy was associated with decreased length of stay, with no observable increase in complication or readmission rates.

Contexte: Les protocoles de récupération optimisée, ou réhabilitation précoce, après une intervention chirurgicale permettent de réduire les taux de complications postopératoires et d'abréger le séjour hospitalier. Les objectifs de cette étude étaient d'appliquer les principes de récupération optimisée après une chirurgie (ou ERAS, enhanced recovery after surgery) à des patients soumis à une lobectomie par chirurgie thoracique vidéo-assistée (CTVA), d'évaluer l'innocuité et l'efficience d'un tel protocole en mesurant les paramètres postopératoires associés, et de comparer l'issue de l'intervention chez les patients du groupe ERAS à celle des patients d'un groupe témoin apparié par score de propension. Méthodes: Il s'agit d'un essai clinique prospectif. Des patients qui devaient subir une lobectomie par CTVA au Centre hospitalier de l'Université de Montréal, à Montréal, Québec, Canada, ont été recrutés entre novembre 2015 et octobre 2016. Les principes ERAS ont été appliqués à tous les patients inscrits. Le paramètre principal était le nombre et la gravité des complications mesurés à l'aide de l'Indice global de complications. Les paramètres secondaires incluaient la durée du séjour, les réadmissions et le rétablissement. Le rétablissement des patients a été mesuré à l'aide du questionnaire EQ-5D-5L avant, puis 1 semaine, 1 mois et 4 mois après la chirurgie. Les patients recrutés prospectivement ont été assortis à des témoins historiques par score de propension. Résultats: Au total, 98 patients (36 hommes et 62 femmes) du groupe ERAS et 98 patients du groupe témoin (29 hommes et 69 femmes) ont été inclus dans l'analyse. L'âge moyen était de 65,2 ± 9,3 ans, l'indice de masse corporelle (IMC) moyen était de 26,9 ± 5,9 kg/m2 et l'indice de comorbidité de Charlson médian était de 2 (éventail interquartile [ÉIQ] 2­3) dans le groupe ERAS. Dans le groupe témoin, l'âge moyen était de 66,2 ± 9,4 ans, l'IMC moyen était de 27,4 ± 5,6 kg/m2 et l'indice de comorbidité de Charlson médian était de 3 (ÉIQ 2­3). En tout, 23 patients (23,4 %) du groupe ERAS et 28 (28,6 %) du groupe témoin ont présenté au moins une complication postopératoire. L'Indice global de complications a été de 7,4 ± 16,8 dans le groupe ERAS, contre 8,0 ± 14,3 dans le groupe témoin (p = 0,79). La durée médiane du séjour postopératoire a été de 3 jours dans le groupe ERAS et de 5 jours dans le groupe témoin (p < 0,001). Cinq patients du groupe ERAS et 4 patients du groupe témoin ont été réadmis. Le taux d'adhésion au protocole a été de 64,3 %. Conclusion: Il est possible d'appliquer un protocole de récupération optimisée après la lobectomie par CTVA. Même si ce protocole en est encore à ses débuts au Canada, l'application de principes ERAS après la lobectomie par CTVA a été associée à un abrègement du séjour hospitalier, sans augmentation observable des taux de complications ou de réadmissions.

When Should Negative Endobronchial Ultrasonography Findings be Confirmed by a More Invasive Procedure?

The treatment of non-small cell lung cancer is largely dependent on accurate staging in order to determine appropriate therapy. Despite advances in imaging, such as computed tomography and positron emission tomography, invasive mediastinal staging is frequently needed to rule out mediastinal involvement prior to curative-intent stereotactic ablative radiotherapy or surgical resection. Surgical mediastinal staging with mediastinoscopy, or anterior mediastinotomy, were traditionally considered the gold standard for invasive mediastinal staging. Endobronchial and endoscopic ultrasound have emerged as modern techniques that are being used as first-line options instead of surgical staging. As experience is gained with these newer techniques, the need for confirmatory surgical staging continues to diminish. This article addresses the situations in which negative results should be confirmed by a more invasive procedure.

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.

The Use of Energy in VATS Lobectomy.

VATS lobectomy is a safe and effective treatment strategy for operable stage I and II lung cancer. It has a similar five-year survival compared to open lobectomy (thoracotomy). VATS lobectomy is associated with less postoperative complications and shorter hospital length of stay when compared to lobectomy by thoracotomy. VATS lobectomy has not been widely adopted by the thoracic surgical community, in part, due to technical reasons. Pulmonary artery branch manipulation in VATS lobectomy is one of the most critical parts of the procedure, especially when endostaplers are used for ligation and division of the vessel. Energy devices have improved in recent years, and their application for VATS lobectomy is gaining traction. There is more and more evidence supporting the safety of ultrasonic shears to seal and divide small pulmonary artery branches. These devices are smaller and finer than endostaplers and have the potential to reduce the risk of PA injury. These more user-friendly devices may enable thoracic surgeons who are currently performing lobectomy by thoracotomy to transition to VATS. Energy devices are also useful for hilar dissection and mediastinal lymph node dissection in VATS lobectomy.

Defining Optimal Settings for Lung Cryobiopsy in End-Stage Pulmonary Disease. A Human, Ex Vivo, Diseased Lung Clinical Trial.

BACKGROUND: To evaluate optimal settings of probe size, freezing time, and distance to the pleura that influence the size and quality of biopsy specimens during transbronchial lung cryobiopsies in ESPD. METHODS: We prospectively recruited 17 patients undergoing lung transplantation. We created a nonperfused ex vivo bronchoscopy setting to perform multiple cryobiopsies with different probe sizes (1.7, 1.9, and 2.4 mm), freezing times (3, 5, 7, 10, 20, 30 seconds), and probe distance from pleura (5, 10, and 20 mm). Alveolated pulmonary parenchyma area≥50% in histology was considered a good quality biopsy, with a minimum procedural artifact. We used logistic regression to identify independent parameters as risk factors for histologic adequacy. RESULTS: A total of 545 cryobiopsies were obtained from 34 explanted lungs after pneumonectomy for lung transplantation. The mean maximum diameter of the specimen achieved with the 1.7 probe was larger (13.5 mm) than those obtained with 1.9 and 2.4 mm probes (11.3 and 10.7 mm, P= 0.07). More pleural macroscopic damage and pleural tissue in histology occurred with the 2.4 mm probe ( P <0.001). There was no difference in the quality of specimens between the different freezing times and the distance from the pleura. CONCLUSIONS: Freezing time and distance from the pleura did not affect the histologic quality for diagnosing ESPD in severely damaged lungs. Smaller cryoprobe size did not negatively affect sample adequacy.

Intersurgeon variations in postoperative length of stay after video-assisted thoracoscopic surgery lobectomy.

Objectives: To identify factors associated with prolonged postoperative length of stay (LOS) after VATS lobectomy (VATS-L), explore potential intersurgeon variation in LOS and ascertain whether or not early discharge influences hospital readmission rates. Methods: We conducted a retrospective analysis of patients who underwent VATS-L at a single academic center between 2018 and 2021. Each VATS lobectomy procedure was performed by 1 of 7 experienced thoracic surgeons. The primary end point of interest was prolonged LOS, defined as an index LOS >3 days. Results: Among 1006 patients who underwent VATS lobectomy, 632 (63%) had a prolonged LOS. On multivariate analysis, the factors independently associated with prolonged LOS were: surgeon (P < .001), patient age (odds ratio [OR], 1.03; 95% CI, 1.02-1.06), operation time (OR, 1.01; 95% CI, 1.01-1.01), postoperative complication (OR, 3.60; 95% CI, 2.45-5.29), and prolonged air leak (OR, 8.95; 95% CI, 4.17-19.23). There was no significant association between LOS and gender, body mass index, coronary artery disease, prior atrial fibrillation, American Society of Anesthesiologists score >3, and prior ipsilateral thoracic surgery or sternotomy. There was no association between LOS ≤3 days and hospital readmission (20 [5.3%] vs 39 [5.9%]; OR, 0.88; 95% CI, 0.50-1.53). Conclusions: An intersurgeon variation in postoperative LOS after VATS-L exists and is independent of patient baseline characteristics or perioperative complications. This variation seems to be more closely related to differences in postoperative management and discharge practices rather than to surgical quality. Postoperative discharge within 3 days is safe and does not increase hospital readmissions.

Lobectomy, segmentectomy, or wedge resection for peripheral clinical T1aN0 non-small cell lung cancer: A post hoc analysis of CALGB 140503 (Alliance).

BACKGROUND: We have recently reported the primary results of CALGB 140503 (Alliance), a randomized trial in patients with peripheral cT1aN0 non-small cell lung cancer (American Joint Committee on Cancer seventh) treated with either lobar resection (LR) or sublobar resection (SLR). Here we report differences in disease-free survival (DFS), overall survival (OS) and lung cancer-specific survival (LCSS) between LR, segmental resection (SR), and wedge resection (WR). We also report differences between WR and SR in terms of surgical margins, rate of locoregional recurrence (LRR), and expiratory flow rate at 6 months postoperatively. METHODS: Between June 2007 and March 2017, a total of 697 patients were randomized to LR (n = 357) or SLR (n = 340) stratified by clinical tumor size, histology, and smoking history. Ten patients were converted from SLR to LR, and 5 patients were converted from LR to SLR. Survival endpoints were estimated using the Kaplan-Maier estimator and tested by the stratified log-rank test. The Kruskal-Wallis test was used to compare margins and changes in forced expiratory volume in 1 second (FEV1) between groups, and the χ2 test was used to test the associations between recurrence and groups. RESULTS: A total of 362 patients had LR, 131 had SR, and 204 had WR. Basic demographic and clinical and pathologic characteristics were similar in the 3 groups. Five-year DFS was 64.7% after LR (95% confidence interval [CI], 59.6%-70.1%), 63.8% after SR (95% CI, 55.6%-73.2%), and 62.5% after WR (95% CI, 55.8%-69.9%) (P = .888, log-rank test). Five-year OS was 78.7% after LR, 81.9% after SR, and 79.7% after WR (P = .873, log-rank test). Five-year LCSS was 86.8% after LR, 89.2% after SR, and 89.7% after WR (P = .903, log-rank test). LRR occurred in 12% after SR and in 14% after WR (P = .295). At 6 months postoperatively, the median reduction in % FEV1 was 5% after WR and 3% after SR (P = .930). CONCLUSIONS: In this large randomized trial, LR, SR, and WR were associated with similar survival outcomes. Although LRR was numerically higher after WR compared to SR, the difference was not statistically significant. There was no significant difference in the reduction of FEV1 between the SR and WR groups.