Roodenburg Sharyn A, Klooster Karin, Hartman Jorine E, Kontogianni Konstantina, Brock Judith M, Dittrich A Susanne, van Dijk Marlies, Koster T David, Herth Felix J F, Slebos Dirk-Jan
Department of Pulmonary Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Groningen Research Institute for Asthma and COPD, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Respiration. 2025;104(1):58-68. doi: 10.1159/000541366. Epub 2024 Sep 16.
Currently, there is a lack of bronchoscopic lung volume reduction options that do not depend on fissure integrity. Endobronchial coils have been extensively studied to address this need but exhibited variable patient response and have been discontinued. Lung tension device (LTD) coils represent the next-generation coil treatment. This study aimed to evaluate safety, feasibility, and efficacy of LTD-coil treatment.
Patients with advanced emphysema and hyperinflation were enrolled at two European sites. LTD-coils (Free Flow Medical, Fremont, CA, USA) were implanted in the two most destructed lobes, as determined by quantitative CT analysis, in two separate procedures. The primary endpoint was 3-month follow-up after the last treatment.
Fourteen patients (50% male, median age 64 years, FEV1 23%predicted, RV 249%predicted) received LTD-coil treatment: 12 received bilateral and 2 unilateral treatment. Six serious respiratory adverse events occurred within the initial 3 months posttreatment, including one device-associated death. Treatment significantly reduced in- and expiratory volume of the treated lobes (-410 [-710, -340], p = 0.004 and -650 [-730, -190] mL, p < 0.001, respectively) and improved quality of life (SGRQ total score -4.6 [-21.0, -2.6], p < 0.001). However, at a group level, no significant improvements in pulmonary function or 6-min walk distance were observed. Responder rates ranged from 18% to 54% for the different endpoints.
This first-in-human study shows that the new LTD-coil procedure is feasible with a safety profile comparable to the previous coil treatment. While the treatment effectively reduced lobar volume and modestly improved quality of life up to 3 months' follow-up, at a group level it did not significantly enhance pulmonary function or exercise capacity.
目前，缺乏不依赖肺裂完整性的支气管镜下肺减容选择。支气管内线圈已被广泛研究以满足这一需求，但患者反应不一，且已停止使用。肺张力装置（LTD）线圈代表了下一代线圈治疗。本研究旨在评估LTD线圈治疗的安全性、可行性和有效性。
在欧洲的两个地点招募了患有晚期肺气肿和肺过度充气的患者。根据定量CT分析，在两个独立的操作中，将LTD线圈（美国加利福尼亚州弗里蒙特市自由流动医疗公司）植入两个破坏最严重的肺叶。主要终点是最后一次治疗后3个月的随访。
14名患者（50%为男性，中位年龄64岁，FEV1为预测值的23%，RV为预测值的249%）接受了LTD线圈治疗：12例接受双侧治疗，2例接受单侧治疗。在治疗后的最初3个月内发生了6起严重的呼吸不良事件，包括1例与装置相关的死亡。治疗显著减少了治疗肺叶的吸气和呼气容积（分别为-410[-710，-340]，p = 0.004和-650[-730，-190]mL，p < 0.001），并改善了生活质量（SGRQ总分-4.6[-21.0，-2.6]，p < 0.001）。然而，在组水平上，未观察到肺功能或6分钟步行距离有显著改善。不同终点的反应率在18%至54%之间。
这项首次人体研究表明，新的LTD线圈手术是可行的，其安全性与先前的线圈治疗相当。虽然该治疗在3个月的随访中有效减少了肺叶容积并适度改善了生活质量，但在组水平上并未显著提高肺功能或运动能力。
