Endobronchial valves

支气管内瓣膜
  • 文章类型: Journal Article
    背景:经内镜支气管瓣肺减容术治疗晚期慢性阻塞性肺疾病和肺气肿患者的过度充气已被广泛认可。主要挑战包括上叶植入的技术复杂性和所需的支气管内瓣膜的数量。这些问题可以通过在大叶支气管中放置较大直径的瓣膜来解决。这项研究评估了可行性,效率,猪模型中新型阀门PulmValve(PV-13型)的安全性。
    方法:将6个PV-13瓣膜经支气管镜植入6只健康猪的尾叶支气管中。手术时间,瓣膜展开,并记录可移除性。后续检查包括血液检查,胸部CT扫描,和支气管镜检查在30分钟,14天,28天,手术后84天,在最后的随访检查后进行尸检和病理评估。
    结果:成功地在体内部署和移除PV-13瓣膜,中位手术时间为6.5分钟。远端肺体积减少在术后30分钟明显,并在第84天持续监测。未检测到任何PV-13阀门的迁移或故障,但3例出现轻度角度偏差。在前7天内在四只猪中观察到咳嗽,并且在所有猪中观察到局部肉芽组织。无气胸病例,弥漫性肺炎,或咯血被检测到。
    结论:在这项研究中,我们报告了在较短的手术时间内成功植入和移除新瓣膜PulmValve。引起完全的肺叶不张,没有装置迁移,故障,或严重的并发症。需要进一步的研究来评估长期的,对人类患者的持续影响和潜在益处。
    BACKGROUND: Endoscopic lung volume reduction with endobronchial valves has been widely recognized for treating hyperinflation in advanced chronic obstructive pulmonary disease and emphysema patients. The main challenges include the technical complexity of upper lobe implantation and the number of endobronchial valves required. These issues might be addressed by placing larger diameter valves in the lobar bronchus. This study evaluated the feasibility, efficiency, and safety of the new valve PulmValve (model PV-13) in porcine models.
    METHODS: Six PV-13 valves were bronchoscopically implanted into the caudal lobe bronchus of six healthy pigs. The procedure time, valve deployment, and removability were recorded. Follow-up examinations included blood tests, chest CT scans, and bronchoscopy at 30 min, 14 days, 28 days, and 84 days post-procedure, with necropsy and pathological evaluations after the final follow-up examination.
    RESULTS: The successful in vivo deployment and removal of PV-13 valves was established, with a median procedure time of 6.5 min. The distal lung volume reduction was evident at 30 min post-operation and was persistently monitored on day 84. No migration or malfunction of any PV-13 valves was detected, but a mild angle deviation was found in 3 cases. Coughing was observed in four pigs within the first 7 days and localized granulation tissue was observed in all pigs. No cases of pneumothorax, diffuse pneumonia, or hemoptysis were detected.
    CONCLUSIONS: In this study, we report the successful implantation and removal of a new valve PulmValve in a short operation time. Complete lobar atelectasis was induced without device migration, malfunction, or severe complications. Further studies are warranted to evaluate the long-term, sustained effects and potential benefits in human patients.
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  • 文章类型: Journal Article
    目的探讨需过早摘除支气管内膜瓣(EBV)的肺气肿患者CT定量分析(QCT)和肺功能检查(PFT)的变化。
    我们医院的医疗记录列出了274例重度COPD(GOLD3期和4期)和肺气肿患者,他们接受EBV治疗以减少肺容量。在干预之前,进行了完整的评估,包括在完全吸气和完全呼气时获得的扫描的定量计算机断层扫描分析(QCT),肺功能试验(PFT),和临床发现(6分钟步行距离测试(6MWDT)和生活质量问卷)。在这274名患者中,有41名,EBV治疗不成功,由于各种原因必须移除瓣膜。在这41例患者中,共有10例进行了第二次尝试EBV治疗,并进行了全面的重新评估。在我们的回顾性研究中,比较三个时间点的结果:EBV植入前(BL),EBV植入(TP2)后,和EBV外植体(TP3)后。QCT参数包括肺容积,总肺气肿评分(TES,ie,肺气肿指数)和肺衰减的第15百分位数(P15)分别为整个肺和每个肺叶。计算了吸气和呼气之间这些参数的差异(Vol。差异(%),TES差异(%),P15差异(%))。PFT和进一步的临床试验结果取自患者的记录。
    我们发现,即使在瓣膜移植后,靶肺叶仍有持续的治疗效果,同时肺的其余部分也有代偿性过度膨胀。由于这两种不同的影响,整个肺的体积保持相当恒定。此外,整个肺的肺气肿评分略有恶化,而靶叶的TES持续改善。
    有趣的是,我们发现了证据,与我们的期望相反,不成功的EBV治疗可对靶叶QCT评分产生持续的积极影响.
    To investigate changes in quantitative CT analysis (QCT) and pulmonary function tests (PFT) in pulmonary emphysema patients who required premature removal of endobronchial valves (EBV).
    Our hospital\'s medical records listed 274 patients with high-grade COPD (GOLD stages 3 and 4) and pulmonary emphysema who were treated with EBV to reduce lung volume. Prior to intervention, a complete evaluation was performed that included quantitative computed tomography analysis (QCT) of scans acquired at full inspiration and full expiration, pulmonary function tests (PFT), and paraclinical findings (6-minute walking distance test (6MWDT) and quality of life questionnaires). In 41 of these 274 patients, EBV treatment was unsuccessful and the valves had to be removed for various reasons. A total of 10 of these 41 patients ventured a second attempt at EBV therapy and underwent complete reevaluation. In our retrospective study, results from three time points were compared: Before EBV implantation (BL), after EBV implantation (TP2), and after EBV explantation (TP3). QCT parameters included lung volume, total emphysema score (TES, ie, the emphysema index) and the 15th percentile of lung attenuation (P15) for the whole lung and each lobe separately. Differences in these parameters between inspiration and expiration were calculated (Vol. Diff (%), TES Diff (%), P15 Diff (%)). The results of PFT and further clinical tests were taken from the patient\'s records.
    We found persistent therapy effect in the target lobe even after valve explantation together with a compensatory hyperinflation of the rest of the lung. As a result of these two divergent effects, the volume of the total lung remained rather constant. Furthermore, there was a slight deterioration of the emphysema score for the whole lung, whereas the TES of the target lobe persistently improved.
    Interestingly, we found evidence that, contrary to our expectations, unsuccessful EBV therapy can have a persistent positive effect on target lobe QCT scores.
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  • 文章类型: Case Reports
    Cryptococcal disease is an opportunistic infection that occurs primarily among people with advanced HIV disease and is an important cause of morbidity and mortality. Spontaneous pneumothorax (SP) is rare in acquired immune deficiency syndrome (AIDS) patients with pulmonary cryptococcosis (PC), but when it occurs, rapid and effective treatment is crucial to the prognosis, with mortality rates varying from 30 to 60%. SP is related to pneumonia mainly due to bacterial infections and pneumocystic jirovecii pneumonia (PJP). However, SP caused by PC is rare. When it occurs, it is often fatal and refractory, which is a challenge both for patients and clinicians. Here, we report a case of SP during the treatment of cryptococcal disease in a patient with AIDS. The pneumothorax remained despite chest tube drainage and evolved into a bronchopleural fistula that was confirmed by the Chartis system. The pneumothorax was significantly resolved following the placement of 2 endobronchial valves (EBVs). The patient tolerated the procedure very well and the pneumothorax gradually resolved. When immunocompromised patients suffer from refractory pneumothorax or prolonged air leaks, EBV implantation may be a feasible and minimally invasive procedure for this vulnerable population.
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  • 文章类型: Journal Article
    慢性阻塞性肺疾病(COPD)已成为我国发病率和死亡率的主要原因,烟草烟雾,空气污染,职业生物危害是主要的危险因素。
    REACH试验是多中心的,prospective,在中国进行的随机对照试验,以评估Spatient®Valve系统(SVS)与标准医疗相比在COPD合并重度肺气肿患者中的安全性和有效性。
    严重气流阻塞的患者,恶性通货膨胀,和叶间裂完整性的严重呼吸困难进行了评估。总共107名受试者以2:1的分配比例随机分配到治疗组(SVS瓣膜和医疗管理)或对照组(单独的医疗管理)。
    3个月主要终点显示,与对照组相比,治疗组1s内用力呼气量有统计学意义的改善(0.104±0.18vs.0.003±0.15L,p=0.001),差异持续6个月。在3个月(平均变化684.4±686.7mL)和6个月(757.0±665.3mL)时达到了统计学上显着的目标肺叶体积减少。治疗组的运动功能和生活质量措施有所改善,但对照组表现恶化。严重不良事件(SAE)发生率治疗组为33%,对照组为24.2%。在两组中,SAE以COPD急性加重为主。对照组死亡1例,治疗组无死亡病例。
    SVS代表了一种治疗严重肺气肿的新方法,具有临床上可接受的风险-收益特征。
    Chronic obstructive pulmonary disease (COPD) has become a leading cause of morbidity and mortality in China, with tobacco smoke, air pollution, and occupational biohazards being the major risk factors.
    The REACH trial is a multicenter, prospective, randomized controlled trial undertaken in China to assess the safety and effectiveness of the Spiration® Valve System (SVS) compared to standard medical care in COPD patients with severe emphysema.
    Patients with severe airflow obstruction, hyperinflation, and severe dyspnea with interlobar fissure integrity were evaluated for enrollment. A total of 107 subjects were randomized in a 2: 1 allocation ratio to either the treatment group (SVS valves and medical management) or the control group (medical management alone).
    The 3-month primary endpoint showed statistically significant improvement in forced expiratory volume in 1 s in the treatment group compared to the control group (0.104 ± 0.18 vs. 0.003 ± 0.15 L, p = 0.001), with the difference being durable through 6 months. Statistically significant target lobe volume reduction was achieved at 3 months (mean change 684.4 ± 686.7 mL) and through 6 months (757.0 ± 665.3 mL). Exercise function and quality of life measures improved in the treatment group, but showed a deterioration in the control group. The serious adverse event (SAE) rate was 33% in the treatment group and 24.2% in the control group. The predominance of SAEs were acute exacerbations of COPD in both groups. There was 1 death in the control group and no deaths in the treatment group.
    The SVS represents a novel approach for the treatment of severe emphysema with a clinically acceptable risk-benefit profile.
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  • 文章类型: Journal Article
    背景:越来越多的随机对照试验(RCT)表明支气管镜肺减容术(BLVR)对重度肺气肿有效。在这个荟萃分析中,我们研究了BLVR对重度肺气肿患者的疗效和安全性.
    方法:PubMed,搜索了Embase和Cochrane图书馆以及相关文章的参考列表,包括评估BLVR治疗与常规治疗的RCTs。仅在纳入RCTs≥2项试验时进行Meta分析。
    结果:总计,3个支气管线圈的随机对照试验,包括6个支气管内瓣膜(EBV)的RCTs和2个支气管内瓣膜(IBV)的RCTs。与常规治疗相比,支气管线圈在1秒用力呼气量(FEV1)的最小临床重要差异(MCID)中显示出更好的反应(RR=2.37,95%CI=1.61-3.48,p<0.0001),6分钟步行试验(6MWT)(RR=2.05,95%CI=1.18-3.53,p=0.01),圣乔治呼吸问卷(SGRQ)(RR=2.32,95%CI=1.77-3.03,p<0.00001)。EBV治疗FEV1也达到了临床上的显着改善(RR=2.96,95%CI=1.49-5.87,p=0.002),在6MWT中(RR=2.90,95%CI=1.24-6.79,p=0.01),和SGRQ(RR=1.53,95%CI=1.22-1.92,p=0.0002)。线圈和EBV治疗在FEV1、6MWT、和SGRQ从基线,还伴有严重的不良反应。此外,亚组分析显示,线圈组的均质和异质肺气肿之间没有差异。然而,IBV组未显示优于常规组。
    结论:当前的荟萃分析表明,线圈或EBV治疗可以显着改善肺功能,锻炼能力,与常规治疗相比,生活质量。线圈治疗可应用于均匀肺气肿,但还需要进一步的试验.
    BACKGROUND: Increasing randomized controlled trials (RCTs) indicate that bronchoscopic lung volume reduction (BLVR) is effective for severe emphysema. In this meta-analysis, we investigated the efficacy and safety of BLVR in patients with severe emphysema.
    METHODS: PubMed, Embase and the Cochrane Library and reference lists of related articles were searched, and RCTs that evaluated BLVR therapy VS conventional therapy were included. Meta-analysis was performed only when included RCTs ≥ 2 trials.
    RESULTS: In total, 3 RCTs for endobronchial coils, 6 RCTs for endobronchial valves (EBV) and 2 RCTs for intrabronchial valves (IBV) were included. Compared with conventional therapy, endobronchial coils showed better response in minimal clinically important difference (MCID) for forced expiratory volume in 1s (FEV1) (RR = 2.37, 95% CI = 1.61 - 3.48, p < 0.0001), for 6-min walk test (6MWT) (RR = 2.05, 95% CI = 1.18 - 3.53, p = 0.01), and for St. George\'s Respiratory Questionnaire (SGRQ) (RR = 2.32, 95% CI = 1.77 - 3.03, p < 0.00001). EBV therapy also reached clinically significant improvement in FEV1 (RR = 2.96, 95% CI = 1.49 - 5.87, p = 0.002), in 6MWT (RR = 2.90, 95% CI = 1.24 - 6.79, p = 0.01), and in SGRQ (RR = 1.53, 95% CI = 1.22 - 1.92, p = 0.0002). Both coils and EBV treatment achieved statistically significant absolute change in FEV1, 6MWT, and SGRQ from baseline, also accompanied by serious adverse effects. Furthermore, subgroup analysis showed there was no difference between homogeneous and heterogeneous emphysema in coils group. However, IBV group failed to show superior to conventional group.
    CONCLUSIONS: Current meta-analysis indicates that coils or EBV treatment could significantly improve pulmonary function, exercise capacity, and quality of life compared with conventional therapy. Coils treatment could be applied in homogeneous emphysema, but further trials are needed.
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  • 文章类型: Case Reports
    Satisfactory functional outcomes following bronchoscopic lung volume reduction (BLVR) using endobronchial valves (EBVs) depend on the absence of collateral ventilation (CV) between the target and adjunct lobes. The Chartis system has proven to be useful for determining whether CV is present or absent, but this system can also erroneously indicate the absence of CV, which can lead to BLVR failure. Here, we describe low-flow Chartis phenotype in the target lobe resulted in difficult judgment of existence of CV. Consequently, BLVR with EBVs implanted into the right upper bronchus failed to reduce lung volume or induce atelectasis. Inserting another EBV into the right middle bronchus blocked the latent CV, which led to significant lung volume reduction in the right upper lobe (RUL) and right middle lobe (RML) and to improve the pulmonary function, 6-min walking distance, and St George respiratory questionnaire scores over a 2-week follow-up period. Low flow in the target lobe is a unique Chartis phenotype and represents the uncertainty of CV, which is a risk factor for the failure of BLVR using EBVs. Clinicians should be aware of this possibility and might be able to resolve the problem by blocking the RUL and RML between which the CV occurs.
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