First in Human Experience of the Performance of the New 5.5-LP Size Zephyr Endobronchial Valve.

首先在人类经验的性能新的 5.5-LP 尺寸的 Zephyr 支气管内瓣膜。

  • 影响因子:2.30
  • DOI:10.1159/000504182
  • 作者列表:"Klooster K","van Dijk M","Koster TD","Slebos DJ
  • 发表时间:2020-01-01

BACKGROUND:Bronchoscopic lung volume reduction using the Zephyr® endobronchial valve (EBV) is a guideline treatment for patients with advanced emphysema. To achieve volume reduction, it is crucial that there is absence of collateral ventilation and a complete occlusion of the target lobe. While 3 EBV sizes (4.0; 4.0-LP; and 5.5) are currently available to accommodate all airway sizes, local anatomical variations sometimes warrant a valve with a wide diameter but shorter length. To address this, a new "low profile" 5.5-LP EBV has been introduced. OBJECTIVE:In this study, we evaluated the feasibility, safety, and efficacy of this new 5.5-LP EBV. METHODS:This was a single-center, prospective, open-label study. Patients were included if eligible for valve treatment with a local anatomy suitable to place at least one 5.5-LP EBV. Feasibility of placement of the 5.5-LP EBV was reported. Safety, CT parameters, pulmonary function tests, and St. George's Respiratory Questionnaire (SGRQ) were assessed at baseline and 6 weeks after treatment. RESULTS:We included 30 patients with severe chronic obstructive pulmonary disease (forced expiratory volume in 1 s [FEV1] 29 ± 10%; [RV] 242 ± 46%; and SGRQ 56 ± 11 points). Besides the regular EBV sizes, a median of 1 (1-3) of the new 5.5-LP EBV was placed. No valve adjustment was needed during the initial procedure. A single asymptomatic small pneumothorax was observed in 1 patient. In 4 patients, a revision bronchoscopy was performed due to absence of clinical benefit. In 1 patient, this was related to a dislocation of the 5.5-LP EBV. Clinically relevant improvements were seen in target lobar volume reduction (-1,554 mL), FEV1 +39%, RV -960 mL, and SGRQ -18 points. CONCLUSIONS:In this first in human study, the 5.5-LP EBV could be placed into wide segments with a shorter landing length without unexpected complications and with good efficacy outcomes.


背景: 使用 Zephyr 的支气管镜肺减容术®支气管内瓣膜 (EBV) 是晚期肺气肿患者的指导治疗。要实现减容,关键是没有侧支通气和靶叶完全闭塞。虽然目前有 3 个 EBV 大小 (4.0; 4.0-LP; 和 5.5) 可适应所有气道大小,但局部解剖变异有时需要直径宽但长度较短的瓣膜。为了解决这一问题,引入了一种新的 “低调” 5.5-LP EBV。 目的: 在这项研究中,我们评估了这种新型 5.5-LP EBV 的可行性、安全性和有效性。 方法: 这是一项单中心、前瞻性、开放标签研究。如果符合瓣膜治疗条件,包括适合放置至少一个 5.5-LP EBV 的局部解剖结构的患者。报道了放置 5.5-LP EBV 的可行性。在基线和治疗后 6 周评估安全性、 CT 参数、肺功能检查和圣乔治呼吸问卷 (SGRQ)。 结果: 我们纳入了 30 例重度慢性阻塞性肺疾病患者 (1 s 用力呼气量 [FEV1] 29 ± 10%; [RV] 242 ± 46%; 和 SGRQ 56 ± 11 分)。除了正常的 EBV 大小,新的 5.5-LP EBV 的中位数为 1 (1-3)。初始手术期间不需要阀门调整。1 例患者出现单一无症状的小气胸。在 4 例患者中,由于缺乏临床获益,进行了翻修支气管镜检查。在 1 例患者中,这与 5.5-LP EBV 脱位有关。临床相关改善见于靶脑叶体积减少 (-1,554 mL) 、 FEV1 + 39% 、 RV-960 mL 和 SGRQ-18 分。 结论: 在这项首次人体研究中,5.5-LP EBV 可以放置在较宽的节段中,着陆长度较短,无意外并发症,疗效良好。



来源期刊:Surgical Endoscopy
作者列表:["Yang, Shun-Mao","Chen, Yi-Chang","Ko, Wei-Chun","Huang, Hsin-Chieh","Yu, Kai-Lun","Ko, Huan-Jang","Huang, Pei-Ming","Chang, Yeun-Chung"]

METHODS:Background Dye localization is a useful method for the resection of unidentifiable small pulmonary lesions. This study compares the transbronchial route with augmented fluoroscopic bronchoscopy (AFB) and conventional transthoracic CT-guided methods for preoperative dye localization in thoracoscopic surgery. Methods Between April 2015 and March 2019, a total of 231 patients with small pulmonary lesions who received preoperative dye localization via AFB or percutaneous CT-guided technique were enrolled in the study. A propensity-matched analysis, incorporating preoperative variables, was used to compare localization and surgical outcomes between the two groups. Results After matching, a total of 90 patients in the AFB group ( N  = 30) and CT-guided group ( N  = 60) were selected for analysis. No significant difference was noted in the demographic data between both the groups. Dye localization was successfully performed in 29 patients (96.7%) and 57 patients (95%) with AFB and CT-guided method, respectively. The localization duration (24.1 ± 8.3 vs. 21.4 ± 12.5 min, p  = 0.297) and equivalent dose of radiation exposure (3.1 ± 1.5 vs. 2.5 ± 2.0 mSv, p  = 0.130) were comparable in both the groups. No major procedure-related complications occurred in either group; however, a higher rate of pneumothorax (0 vs. 16.7%, p  = 0.029) and focal intrapulmonary hemorrhage (3.3 vs. 26.7%, p  = 0.008) was noted in the CT-guided group. Conclusion AFB dye marking is an effective alternative for the preoperative localization of small pulmonary lesions, with a lower risk of procedure-related complications than the conventional CT-guided method.

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作者列表:["Matava, Clyde","Pankiv, Evelina","Raisbeck, Sam","Caldeira, Monica","Alam, Fahad"]

METHODS:Background The use of artificial intelligence, including machine learning, is increasing in medicine. Use of machine learning is rising in the prediction of patient outcomes. Machine learning may also be able to enhance and augment anesthesia clinical procedures such as airway management. In this study, we sought to develop a machine learning algorithm that could classify vocal cords and tracheal airway anatomy real-time during video laryngoscopy or bronchoscopy as well as compare the performance of three novel convolutional networks for detecting vocal cords and tracheal rings. Methods Following institutional approval, a clinical dataset of 775 video laryngoscopy and bronchoscopy videos was used. The dataset was divided into two categories for use for training and testing. We used three convolutional neural networks (CNNs): ResNet, Inception and MobileNet. Backpropagation and a mean squared error loss function were used to assess accuracy as well as minimize bias and variance. Following training, we assessed transferability using the generalization error of the CNN, sensitivity and specificity, average confidence error, outliers, overall confidence percentage, and frames per second for live video feeds. After the training was complete, 22 models using 0 to 25,000 steps were generated and compared. Results The overall confidence of classification for the vocal cords and tracheal rings for ResNet, Inception and MobileNet CNNs were as follows: 0.84, 0.78, and 0.64 for vocal cords, respectively, and 0.69, 0.72, 0.54 for tracheal rings, respectively. Transfer learning following additional training resulted in improved accuracy of ResNet and Inception for identifying the vocal cords (with a confidence of 0.96 and 0.93 respectively). The two best performing CNNs, ResNet and Inception, achieved a specificity of 0.985 and 0.971, respectively, and a sensitivity of 0.865 and 0.892, respectively. Inception was able to process the live video feeds at 10 FPS while ResNet processed at 5 FPS. Both were able to pass a feasibility test of identifying vocal cords and tracheal rings in a video feed. Conclusions We report the development and evaluation of a CNN that can identify and classify airway anatomy in real time. This neural network demonstrates high performance. The availability of artificial intelligence may improve airway management and bronchoscopy by helping to identify key anatomy real time. Thus, potentially improving performance and outcomes during these procedures. Further, this technology may theoretically be extended to the settings of airway pathology or airway management in the hands of experienced providers. The researchers in this study are exploring the performance of this neural network in clinical trials.

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作者列表:["Dhooria S","Chaudhary S","Ram B","Sehgal IS","Muthu V","Prasad KT","Aggarwal AN","Agarwal R"]

METHODS:BACKGROUND:The optimal mode of delivering topical anesthesia during flexible bronchoscopy remains unknown. This article compares the efficacy and safety of nebulized lignocaine, lignocaine oropharyngeal spray, or their combination. METHODS:Consecutive subjects were randomized 1:1:1 to receive nebulized lignocaine (2.5 mL of 4% solution, group A), oropharyngeal spray (10 actuations of 10% lignocaine, group B), or nebulization (2.5 mL, 4% lignocaine) and two actuations of 10% lignocaine spray (group C). The primary outcome was the subject-rated severity of cough according to a visual analog scale. The secondary outcomes included bronchoscopist-rated severity of cough and overall procedural satisfaction on a visual analog scale, total lignocaine dose, subject's willingness to undergo a repeat procedure, adverse reactions to lignocaine, and others. RESULTS:A total of 1,050 subjects (median age, 51 years; 64.8% men) were included. The median (interquartile range) score for subject-rated cough severity was significantly lower in group B compared to group C or group A (4 [1-10] vs 11 [4-24] vs 13 [5-30], respectively; P < .001). The bronchoscopist-rated severity of cough was also the least (P < .001), and the overall satisfaction was highest in group B (P < .001). The cumulative lignocaine dose administered was the least in group B (P < .001). A significantly higher proportion of subjects (P < .001) were willing to undergo a repeat bronchoscopy in group B (73.7%) than in groups A (49.1%) and C (59.4%). No lignocaine-related adverse events were observed. CONCLUSIONS:Ten actuations of 10% lignocaine oropharyngeal spray were superior to nebulized lignocaine or their combination for topical anesthesia during diagnostic flexible bronchoscopy. TRIAL REGISTRY:ClinicalTrials.gov; No.: NCT03109392; URL: www.clinicaltrials.gov.

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