Bronchial Rheoplasty for Treatment of Chronic Bronchitis. Twelve-Month Results from a Multicenter Clinical Trial.

Rationale: Chronic bronchitis (CB) is characterized by productive cough with excessive mucus production, resulting in quality-of-life impairment and increased exacerbation risk. Bronchial rheoplasty uses an endobronchial catheter to apply nonthermal pulsed electrical fields to the airways. Preclinical studies have demonstrated epithelial ablation followed by regeneration of normalized epithelium.Objectives: To evaluate the feasibility, safety, and initial outcomes of bronchial rheoplasty in patients with CB.Methods: Pooled analysis of two separate studies enrolling 30 patients undergoing bilateral bronchial rheoplasty was conducted. Follow-up through 6 months (primary outcome) and 12 months included assessment of adverse events, airway histology, and changes in symptoms using the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test and St. George's Respiratory Questionnaire (SGRQ).Measurements and Main Results: Bronchial rheoplasty was performed in all 30 patients (63% male; mean [SD] age, 67 [7.4]; mean [SD] postbronchodilator FEV1, 65% [21%]; mean [SD] COPD Assessment Test score 25.6 [7.1]; mean [SD] SGRQ score, 59.6 [15.3]). There were no device-related and four procedure-related serious adverse events through 6 months, and there were none thereafter through 12 months. The most frequent nonserious, device- and/or procedure-related event through 6 months was mild hemoptysis in 47% (14 of 30) patients. Histologically, the mean goblet cell hyperplasia score was reduced by a statistically significant amount (P < 0.001). Significant changes from baseline to 6 months in COPD Assessment Test (mean, -7.9; median, -8.0; P = 0.0002) and SGRQ (mean, -14.6; median, -7.2; P = 0.0002) scores were observed, with similar observations through 12 months.Conclusions: This study provides the first clinical evidence of the feasibility, safety, and initial outcomes of bronchial rheoplasty in symptomatic patients with CB.Clinical trial registered with www.anzctr.org.au (ACTRN 12617000330347) and clinicaltrials.gov (NCT03107494).

Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study.

BACKGROUND: Electromagnetic navigation bronchoscopy (ENB) is an image-guided, minimally invasive approach that uses a flexible catheter to access pulmonary lesions. METHODS: NAVIGATE is a prospective, multicenter study of the superDimension™ navigation system. A prespecified 1-month interim analysis of the first 1,000 primary cohort subjects enrolled at 29 sites in the United States and Europe is described. Enrollment and 24-month follow-up are ongoing. RESULTS: ENB index procedures were conducted for lung lesion biopsy (n = 964), fiducial marker placement (n = 210), pleural dye marking (n = 17), and/or lymph node biopsy (n = 334; primarily endobronchial ultrasound-guided). Lesions were in the peripheral/middle lung thirds in 92.7%, 49.7% were <20 mm, and 48.4% had a bronchus sign. Radial EBUS was used in 54.3% (543/1,000 subjects) and general anesthesia in 79.7% (797/1,000). Among the 964 subjects (1,129 lesions) undergoing lung lesion biopsy, navigation was completed and tissue was obtained in 94.4% (910/964). Based on final pathology results, ENB-aided samples were read as malignant in 417/910 (45.8%) subjects and non-malignant in 372/910 (40.9%) subjects. An additional 121/910 (13.3%) were read as inconclusive. One-month follow-up in this interim analysis is not sufficient to calculate the true negative rate or diagnostic yield. Tissue adequacy for genetic testing was 80.0% (56 of 70 lesions sent for testing). The ENB-related pneumothorax rate was 4.9% (49/1,000) overall and 3.2% (32/1,000) CTCAE Grade ≥2 (primary endpoint). The ENB-related Grade ≥2 bronchopulmonary hemorrhage and Grade ≥4 respiratory failure rates were 1.0 and 0.6%, respectively. CONCLUSIONS: One-month results of the first 1,000 subjects enrolled demonstrate low adverse event rates in a generalizable population across diverse practice settings. Continued enrollment and follow-up are required to calculate the true negative rate and delineate the patient, lesion, and procedural factors contributing to diagnostic yield. TRIAL REGISTRATION: ClinicalTrials.gov NCT02410837 . Registered 31 March 2015.

Pulsed Electric Field (PEF) treatment of progressive non-small cell lung cancer concurrently treated with immune checkpoint blockade: A case report.

Pulsed Electric Field (PEF) energy was delivered at the time of confirmational biopsy to ablate recurrent NSCLC in the right upper lobe (RUL) of the lung after recurrence while on durvalumab consolidation. The patient tolerated the procedure and exhibited stable disease at 6 and 12 months from time of durvalumab discontinuation and PEF treatment, respectively. This report represents the first use of the Aliya™ PEF system as a minimally invasive modality with potential to re-sensitize disease to immune checkpoint blockade (ICB) upon progression. Clinicaltrialsgov identifier: NCT04773275.

Absence of Arrhythmogenicity with Biphasic Pulsed Electric Fields Delivered to Porcine Airways.

Pulsed electric field (PEF) technologies treat many types of tissue. Many systems mandate synchronization to the cardiac cycle to avoid the induction of cardiac arrhythmias. Significant differences between PEF systems make the assessment of cardiac safety from one technology to another challenging. A growing body of evidence suggests that shorter duration biphasic pulses obviate the need for cardiac synchronization, even when delivered in a monopolar fashion. This study theoretically evaluates the risk profile of different PEF parameters. It then tests a monopolar, biphasic, microsecond-scale PEF technology for arrhythmogenic potential. PEF applications of increasing likelihood to induce an arrhythmia were delivered. The energy was delivered throughout the cardiac cycle, including both single and multiple packets, and then with concentrated delivery on the t-wave. There were no sustained changes to the electrocardiogram waveform or to the cardiac rhythm, despite delivering energy during the most vulnerable phase of the cardiac cycle, and delivery of multiple packets of PEF energy across the cardiac cycle. Only isolated premature-atrial contractions (PAC) were observed. This study provides evidence that certain varieties of biphasic, monopolar PEF delivery do not require synchronized energy delivery to prevent harmful arrhythmias.

Airway Microbiota in Patients With Synchronous Multiple Primary Lung Cancer: The Bacterial Topography of the Respiratory Tract.

Microbes and microbiota dysbiosis are correlated with the development of lung cancer; however, the airway taxa characteristics and bacterial topography in synchronous multiple primary lung cancer (sMPLC) are not fully understood. The present study aimed to investigate the microbiota taxa distribution and characteristics in the airways of patients with sMPLC and clarify specimen acquisition modalities in these patients. Using the precise positioning of electromagnetic navigation bronchoscopy (ENB), we analyzed the characteristics of the respiratory microbiome, which were collected from different sites and using different sampling methods. Microbiome predictor variables were bacterial DNA burden and bacterial community composition based on 16sRNA. Eight non-smoking patients with sMPLC in the same pulmonary lobe were included in this study. Compared with other sampling methods, bacterial burden and diversity were higher in surface areas sampled by bronchoalveolar lavage (BAL). Bacterial topography data revealed that the segment with sMPLC lesions provided evidence of specific colonizing bacteria in segments with lesions. After taxonomic annotation, we identified 4863 phylotypes belonging to 185 genera and 10 different phyla. The four most abundant specific bacterial community members detected in the airway containing sMPLC lesions were Clostridium, Actinobacteria, Fusobacterium, and Rothia, which all peaked at the segments with sMPLC lesions. This study begins to define the bacterial topography of the respiratory tract in patients with sMPLC and provides an approach to specimen acquisition for sMPLC, namely BAL fluid obtained from segments where lesions are located.

NAVIGATE 24-Month Results: Electromagnetic Navigation Bronchoscopy for Pulmonary Lesions at 37 Centers in Europe and the United States.

INTRODUCTION: Electromagnetic navigation bronchoscopy (ENB) is a minimally invasive, image-guided approach to access lung lesions for biopsy or localization for treatment. However, no studies have reported prospective 24-month follow-up from a large, multinational, generalizable cohort. This study evaluated ENB safety, diagnostic yield, and usage patterns in an unrestricted, real-world observational design. METHODS: The NAVIGATE single-arm, pragmatic cohort study (NCT02410837) enrolled subjects at 37 academic and community sites in seven countries with prospective 24-month follow-up. Subjects underwent ENB using the superDimension navigation system versions 6.3 to 7.1. The prespecified primary end point was procedure-related pneumothorax requiring intervention or hospitalization. RESULTS: A total of 1388 subjects were enrolled for lung lesion biopsy (1329; 95.7%), fiducial marker placement (272; 19.6%), dye marking (23; 1.7%), or lymph node biopsy (36; 2.6%). Concurrent endobronchial ultrasound-guided staging occurred in 456 subjects. General anesthesia (78.2% overall, 56.6% Europe, 81.4% United States), radial endobronchial ultrasound (50.6%, 4.0%, 57.4%), fluoroscopy (85.0%, 41.7%, 91.0%), and rapid on-site evaluation use (61.7%, 17.3%, 68.5%) differed between regions. Pneumothorax and bronchopulmonary hemorrhage occurred in 4.7% and 2.7% of subjects, respectively (3.2% [primary end point] and 1.7% requiring intervention or hospitalization). Respiratory failure occurred in 0.6%. The diagnostic yield was 67.8% (range: 61.9%-70.7%; 55.2% Europe, 69.8% United States). Sensitivity for malignancy was 62.6%. Lung cancer clinical stage was I to II in 64.7% (55.3% Europe, 65.8% United States). CONCLUSIONS: Despite a heterogeneous cohort and regional differences in procedural techniques, ENB demonstrates low complications and a 67.8% diagnostic yield while allowing biopsy, staging, fiducial placement, and dye marking in a single procedure.

Efficiency of Electromagnetic Navigation Bronchoscopy and Virtual Bronchoscopic Navigation.

BACKGROUND: Image-guided bronchoscopy techniques have emerged as a means of improving pulmonary nodule biopsy yield. However comparisons of the diagnostic efficacy of electromagnetic navigation bronchoscopy (ENB) and virtual bronchoscopic navigation (VBN) have not reached a consensus. This meta-analysis evaluates the overall diagnostic yield and accuracy of ENB and VBN for pulmonary nodules. METHODS: A systematic search was conducted to identify relevant articles. Meta-analysis was used to summarize the sensitivities, specificities, and area under the curve for ENB and VBN. RESULTS: Thirty-two studies (1981 patients with pulmonary nodules) were included in this analysis. The pooled sensitivity, specificity, and area under the curve (95% confidence interval) of ENB were 0.80 (0.73-0.85), 0.81 (0.71-0.88), and 0.87 (0.84-0.90), respectively. Corresponding VBN values were 0.80 (0.76-0.83), 0.65 (0.56-0.73), and 0.81 (0.78-0.85), respectively. Comparison of the 2 techniques revealed that ENB had higher specificity and area under the curve but no difference in sensitivity. CONCLUSIONS: Both ENB and VBN are valuable tools in the diagnosis of lung nodules. ENB achieved a higher specificity than VBN in the diagnose of lung nodules, whereas ENB performed better than VBN for pulmonary nodules. These results are due to the real-time positioning function of ENB.

Standardized Definitions of Bleeding After Transbronchial Lung Biopsy: A Delphi Consensus Statement From the Nashville Working Group.

BACKGROUND: Transbronchial lung biopsies are commonly performed for a variety of indications. Although generally well tolerated, complications such as bleeding do occur. Description of bleeding severity is crucial both clinically and in research trials; to date, there is no validated scale that is widely accepted for this purpose. Can a simple, reproducible tool for categorizing the severity of bleeding after transbronchial biopsy be created? METHODS: Using the modified Delphi method, an international group of bronchoscopists sought to create a new scale tailored to assess bleeding severity among patients undergoing flexible bronchoscopy with transbronchial lung biopsies. Cessation criteria were specified a priori and included reaching > 80% consensus among the experts or three rounds, whichever occurred first. RESULTS: Thirty-six expert bronchoscopists from eight countries, both in academic and community practice settings, participated in the creation of the scale. After the live meeting, two iterations were made. The second and final scale was vetted by all 36 participants, with a weighted average of 4.47/5; 53% were satisfied, and 47% were very satisfied. The panel reached a consensus and proposes the Nashville Bleeding Scale. CONCLUSIONS: The use of a simplified airway bleeding scale that can be applied at bedside is an important, necessary tool for categorizing the severity of bleeding. Uniformity in reporting clinically significant airway bleeding during bronchoscopic procedures will improve the quality of the information derived and could lead to standardization of management. In addition to transbronchial biopsies, this scale could also be applied to other bronchoscopic procedures, such as endobronchial biopsy or endobronchial ultrasound-guided needle aspiration.

Fiducial marker placement with electromagnetic navigation bronchoscopy: a subgroup analysis of the prospective, multicenter NAVIGATE study.

BACKGROUND: Fiducial markers (FMs) help direct stereotactic body radiation therapy (SBRT) and localization for surgical resection in lung cancer management. We report the safety, accuracy, and practice patterns of FM placement utilizing electromagnetic navigation bronchoscopy (ENB). METHODS: NAVIGATE is a global, prospective, multicenter, observational cohort study of ENB using the superDimension™ navigation system. This prospectively collected subgroup analysis presents the patient demographics, procedural characteristics, and 1-month outcomes in patients undergoing ENB-guided FM placement. Follow up through 24 months is ongoing. RESULTS: Two-hundred fifty-eight patients from 21 centers in the United States were included. General anesthesia was used in 68.2%. Lesion location was confirmed by radial endobronchial ultrasound in 34.5% of procedures. The median ENB procedure time was 31.0 min. Concurrent lung lesion biopsy was conducted in 82.6% (213/258) of patients. A mean of 2.2 ± 1.7 FMs (median 1.0 FMs) were placed per patient and 99.2% were accurately positioned based on subjective operator assessment. Follow-up imaging showed that 94.1% (239/254) of markers remained in place. The procedure-related pneumothorax rate was 5.4% (14/258) overall and 3.1% (8/258) grade ⩾ 2 based on the Common Terminology Criteria for Adverse Events scale. The procedure-related grade ⩾ 4 respiratory failure rate was 1.6% (4/258). There were no bronchopulmonary hemorrhages. CONCLUSION: ENB is an accurate and versatile tool to place FMs for SBRT and localization for surgical resection with low complication rates. The ability to perform a biopsy safely in the same procedure can also increase efficiency. The impact of practice pattern variations on therapeutic effectiveness requires further study. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02410837.

Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study.

INTRODUCTION: Electromagnetic navigation bronchoscopy (ENB) is a minimally invasive technology that guides endoscopic tools to pulmonary lesions. ENB has been evaluated primarily in small, single-center studies; thus, the diagnostic yield in a generalizable setting is unknown. METHODS: NAVIGATE is a prospective, multicenter, cohort study that evaluated ENB using the superDimension navigation system (Medtronic, Minneapolis, Minnesota). In this United States cohort analysis, 1215 consecutive subjects were enrolled at 29 academic and community sites from April 2015 to August 2016. RESULTS: The median lesion size was 20.0 mm. Fluoroscopy was used in 91% of cases (lesions visible in 60%) and radial endobronchial ultrasound in 57%. The median ENB planning time was 5 minutes; the ENB-specific procedure time was 25 minutes. Among 1157 subjects undergoing ENB-guided biopsy, 94% (1092 of 1157) had navigation completed and tissue obtained. Follow-up was completed in 99% of subjects at 1 month and 80% at 12 months. The 12-month diagnostic yield was 73%. Pathology results of the ENB-aided tissue samples showed malignancy in 44% (484 of 1092). Sensitivity, specificity, positive predictive value, and negative predictive value for malignancy were 69%, 100%, 100%, and 56%, respectively. ENB-related Common Terminology Criteria for Adverse Events grade 2 or higher pneumothoraces (requiring admission or chest tube placement) occurred in 2.9%. The ENB-related Common Terminology Criteria for Adverse Events grade 2 or higher bronchopulmonary hemorrhage and grade 4 or higher respiratory failure rates were 1.5% and 0.7%, respectively. CONCLUSIONS: NAVIGATE shows that an ENB-aided diagnosis can be obtained in approximately three-quarters of evaluable patients across a generalizable cohort based on prospective 12-month follow-up in a pragmatic setting with a low procedural complication rate.

Towards an optimization of bronchoscopic approaches to the diagnosis and treatment of the pulmonary nodules: a review.

The last several years have seen substantive improvements and innovation with respect to bronchoscopic approaches to the indeterminate pulmonary nodule both diagnostically and therapeutically. Indeed, these advances have only accelerated over the last year or two and extend across multiple domains and include improvements in imaging technologies and techniques, approaches and tools to access different areas of the lung, tools to acquire tissue as well as tools and methods to ablate tissue. Needless to say, there are a variety of different approaches in terms of how these issues are being solved along with differing levels of technology and infrastructure commitments necessary to utilize these various tools, with some of these approaches being farther along than others. This article reviews some of these recent advances in the domains of advanced imaging, approaches to accessing various parts of the lung, tools designed to acquire tissue, robotic endoscopy platforms, new approaches to tissue ablation as well as potential additions to these areas that are on the horizon.

Risks and benefits in treatment of mediastinal abscess by endobronchial ultrasound-guided transbronchial needle aspiration.

INTRODUCTION: Mediastinal abscess is a fatal condition, treatment of mediastinal abscess is with antibiotics and sometimes surgery for debridement and drainage. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a safe assessment and candidate treatment method of mediastinal lesions. OBJECTIVES: This study aimed to HYPERLINK "javascript:void(0);" discuss risks and benefits in treatment of mediastinal abscess by EBUS-TBNA. METHODS: We noticed a 56-year-old man with developed bilateral pneumonia and sepsis after puncture of mediastinal abscess by EBUS-TBNA. The patient was successfully treated with a combination of systemic anti-infection treatment and intracavitary administration of antibiotics, antifungal and repeated drainage and lavage via EBUS-TBNA, in 1 year follow-up without recurrence. RESULTS: This study indicated infection spread risk of mediastinal abscess after EBUS-TBNA, and mediastinal abscess was successfully cured by combination of systemic anti-infection and local intervention through EBUS-TBNA. CONCLUSION: EBUS-TBNA is a potential effective minimally invasive treatment for mediastinal abscess, and it is necessary to be aware of clinical complications after puncture of mediastinal infectious lesions by EBUS-TBNA.

Oncologic emergencies for the internist.

Most cancer patients experience at least one emergency during the course of the disease. This paper reviews the diagnosis and treatment of tumor lysis syndrome, hypercalcemia of malignancy, superior vena cava syndrome, spinal cord compression, strokes and seizures, and treatment-related emergencies.

Thoracoscopic detection of occult indeterminate pulmonary nodules using bronchoscopic pleural dye marking.

BACKGROUND: The annual incidence of a small indeterminate pulmonary nodule (IPN) on computed tomography (CT) scan remains high. While traditional paradigms exist, the integration of new technologies into these diagnostic and treatment algorithms can result in alternative, potentially more efficient methods of managing these findings. METHODS: We report on an alternative diagnostic and therapeutic strategy for the management of an IPN. This approach combines electromagnetic navigational bronchoscopy (ENB) with an updated approach to placement of a pleural dye marker. This technique lends itself to a minimally invasive wedge resection via either video-assisted thoracoscopic surgery (VATS) or a robotic approach. RESULTS: Subsequent to alterations in the procedure, a cohort of 22 patients with an IPN was reviewed. Navigation was possible in 21 out of 22 patients with one patient excluded based on airway anatomy. The remaining 21 patients underwent ENB with pleural dye marking followed by minimally invasive wedge resection. The median size of the nodules was 13.4 mm (range: 7-29). There were no complications from the ENB procedure. Indigo carmine dye was used in ten patients. Methylene blue was used in the remaining 11 patients. In 81% of cases, the visceral pleural marker was visible at the time of surgery. In one patient, there was diffuse staining of the parietal pleura. In three additional patients, no dye was identified within the hemithorax. In all cases where dye marker was present on the visceral pleural surface, it was in proximity to the IPN and part of the excised specimen. CONCLUSIONS: ENB with pleural dye marking can provide a safe and effective method to localize an IPN and can allow for subsequent minimally invasive resection. Depending on the characteristics and location of the nodule, this method may allow more rapid identification intraoperatively.

Safety of pacemakers and defibrillators in electromagnetic navigation bronchoscopy.

BACKGROUND: Electromagnetic Navigation Bronchoscopy (ENB) (InReach iLogic system; superDimension Inc) is a relatively new discipline, with promising diagnostic and therapeutic applications in patients with lung lesions. Navigation is performed in a magnetic field and, therefore, has been considered relatively contraindicated in patients with pacemakers and automated implantable cardioverter-defibrillators (AICDs). Potential risks include altering the function and shutting off the device, device damage, lead displacement, and potential overheating. Over the past decade, there has been extensive literature about the safety of pacemakers in either the 1.5-T or 3-T magnetic fields used in current MRI scanners. Although the magnetic field used in ENB is significantly weaker, 0.0001 T or approximately equal to the earth's gravity, its safety in patients with pacemakers is yet to be elucidated. We present our initial experience with ENB in patients with cardiac implanted electrical devices. METHODS: Twenty-four procedures in 24 patients with lung lesions and permanent pacemakers were performed. A cardiac electrophysiologist and programmer were present during the procedure. At baseline, the pacers were interrogated, and ECG was recorded. Continuous cardiac monitoring was performed during the procedure, and at the end, the pacer settings and function were reinterrogated to check for any changes. RESULTS: The procedures were all successfully concluded. None of the patients suffered any arrhythmias or disruption to their pacemakers' function. CONCLUSION: ENB appears to be safe when performed in patients with pacemakers and AICDs. Larger multicenter studies are needed to prove the final safety in this patient population.

Optimization of mediastinal staging in potential candidates for stereotactic radiosurgery of the chest.

OBJECTIVE: Patients with medically inoperable nonsmall-cell lung cancer generally have limited staging of the mediastinum using computed tomography and combined positron emission tomography and computed tomography, before stereotactic radiosurgery. Historical data have demonstrated the superiority of tissue sampling techniques such as endobronchial ultrasonography and mediastinoscopy compared with imaging studies in accurately determining the nodal stage. We believe, that at a minimum, mediastinal interrogation with endobronchial ultrasonography should be performed before patients undergo stereotactic radiosurgery. METHODS: A retrospective review of 59 consecutive patients undergoing bronchoscopic fiducial marker placement as potential candidates for stereotactic radiosurgery was done. All these patients had undergone endobronchial ultrasonography to assess the mediastinum. Transbronchial needle aspirates were taken using standard criteria defined by a lymph node size greater than 5 mm in diameter and/or in the appropriate lymph node drainage pathway. The biopsies were reviewed by the institution's pathologists. RESULTS: Mediastinal lymph node specimens were not taken in 9 patients because they did not meet our criteria. Of the 50 patients who underwent mediastinal lymph node sampling, 10 had evidence of nodal involvement. On review, 2 of these 10 patients had evidence of mediastinal adenopathy on computed tomography. After excluding those 2 patients, the mediastinal lymph nodes were positive for metastatic disease in 8 (16%) of 50 patients without previous radiographic evidence of disease. These patients were previously thought to be suitable candidates for stereotactic radiosurgery. Also 5 of 10 patients with endobronchial ultrasound-positive lymph nodes had had positron emission tomography-negative findings in the mediastinum. Finally, 10% of the patients suspected to have stage II or III were downstaged with endobronchial ultrasonography and considered for stereotactic radiosurgery. CONCLUSIONS: Endobronchial ultrasonography-transbronchial needle aspirates is more accurate than computed tomography and positron emission tomography in staging the mediastinum, can be performed with minimal morbidity, and should be considered for all patients considered candidates for stereotactic radiosurgery.

Airway spray cryotherapy: initial outcomes from a multiinstitutional registry.

BACKGROUND: Spray cryotherapy (SCT) uses a noncontact system to deliver liquid nitrogen (2 to 4 psi) through an endoscopic catheter. Rapid freezing and thawing of tissue causes cellular death and is also hemostatic. We report the preliminary results from 6 institutions in which SCT was used for the treatment of malignant airway tumors. METHODS: SCT was performed on patients with symptomatic airway tumors and reviewed retrospectively. Airway narrowing was graded as 25% or smaller, 26% to 50%, 51% to 75%, and exceeding 75%. All events were documented and assessed. RESULTS: Eighty patients (45 male [56%]) underwent 114 treatments. Median age was 66 years (range, 15 to 90 years). All patients were treated with minimal blood loss. Fifty-eight percent of the cases were outpatient procedures. Airway obstruction exceeded 75% in most of the lesions treated. There were 21 intraoperative events (19%), including hypotension, bradycardia and tachycardia, ST segment changes, desaturation, and an airway tear. Three pneumothoraces occurred, one requiring emergency chest tube placement. Two intraoperative deaths were associated with bradycardia. Three postoperative deaths occurred in patients who were transitioned to comfort care. All but 1 patient had airway patency after treatment. CONCLUSIONS: SCT can be used in patients with highly vascular tumors, with reduced bleeding complications and a low overall complication rate. Caution is needed before SCT is used on a widespread basis, given the intraoperative complications. Although the potential benefit of SCT is considerable, this needs to be confirmed in larger studies.

Spray cryotherapy for the treatment of glottic and subglottic stenosis.

OBJECTIVES/HYPOTHESIS: Functional partial occlusion of the glottic and subglottic areas by stenosis and strictures is challenging to manage despite a variety of surgical and endoluminal approaches that are prone to complications and inconsistent outcomes. We report here the first three human cases of glottic and subglottic narrowing treated with spray cryotherapy alone or in combination with balloon dilation. STUDY DESIGN: Institutional review board-approved clinical human trial. METHODS: A 42-year-old female with idiopathic subglottic strictures, a 74-year-old female with glottic strictures and vocal cord stenosis following neck radiation, and a 33-year-old female with strictures from a previous tracheal stent were treated by four cycles of a 5-second cryotherapy spray alone or with balloon dilation. The effects of treatment were observed up to 6 months, 12 weeks, and 9 months, respectively. RESULTS: In all cases, patency of the stenosed areas was achieved with minimal bleeding and at least some degree of normalization of the glottic and subglottic mucosa. Airway patency and laryngeal functions were restored without complications. CONCLUSIONS: The use of spray cryotherapy alone or in conjunction with balloon dilation is a promising and effective therapeutic approach to treating glottic and subglottic narrowing.