重度肺气肿的支气管内线圈治疗：来自瑞士国家登记处的6个月结果

Endobronchial coil therapy in severe emphysema: 6-month outcomes from a Swiss National Registry.

作者信息

Fellrath Jean-Marc, Scherer Thomas, Franzen Daniel P, Lovis Alban, von Garnier Christophe, Plojoux Jérôme, Soccal Paola M

机构信息

Department of Pulmonary Medicine, Pourtales Hospital, Neuchatel, Switzerland.

LungenZentrum Hirslanden, Zurich, Switzerland.

出版信息

J Thorac Dis. 2018 Aug;10(Suppl 23):S2711-S2718. doi: 10.21037/jtd.2018.04.53.

DOI:10.21037/jtd.2018.04.53

PMID:30210823

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6129812/

Abstract

BACKGROUND

Endobronchial coils have been demonstrated in three randomized, controlled trials to improve quality of life, exercise tolerance, and lung function in patients with severe emphysema. This therapy is CE-marked and commercially available in Switzerland. Coil treated patients are followed in a post-market Swiss registry to collect safety and effectiveness data in routine clinical practice.

METHODS

The Swiss coil registry was initiated in October 2013. At the end of November 2016, an interim analysis of all 64 patients treated in five centers was performed to evaluate safety and effectiveness at six months post treatment.

RESULTS

patients had completed bilateral treatment with 6-month follow up at the time of data analysis. Patients had very severe, symptomatic emphysema and hyperinflation [38% male, mean age 66 years, BMI 24, FEV1 30% pred., residual volume (RV) 247% pred., 6-minute walking distance (6-MWD) 272 m, St. George Respiratory Questionnaire (SGRQ) 57 points]. Up to 6 months following treatment, seven serious adverse events (SAE) were reported in 6/29 patients. No device removals were necessary. At 6 months, responder rates [% achieving the minimal clinically important difference (MCID)] were as follows: RV (-0.35 L) 76%; FEV1 (+10%) 57%; SGRQ (-4 points) 87%; 6MWD (+26 m) 60%.

CONCLUSIONS

Endobronchial coil therapy performed in expert centers in Switzerland yields high 6-month responder rates across all relevant outcome.

摘要

背景

三项随机对照试验已证明，支气管内线圈可改善重度肺气肿患者的生活质量、运动耐量和肺功能。该疗法已获得CE认证，在瑞士可商业应用。接受线圈治疗的患者在瑞士上市后登记处接受随访，以收集常规临床实践中的安全性和有效性数据。

方法

瑞士线圈登记始于2013年10月。2016年11月底，对五个中心治疗的所有64例患者进行了中期分析，以评估治疗后6个月的安全性和有效性。

结果

在数据分析时，患者已完成双侧治疗并进行了6个月的随访。患者患有非常严重的症状性肺气肿和肺过度充气[男性占38%，平均年龄66岁，体重指数24，第1秒用力呼气容积（FEV1）为预计值的30%，残气量（RV）为预计值的247%，6分钟步行距离（6-MWD）为272米，圣乔治呼吸问卷（SGRQ）评分为57分]。治疗后长达6个月，29例患者中有6例报告了7起严重不良事件（SAE）。无需取出装置。在6个月时，缓解率[达到最小临床重要差异（MCID）的百分比]如下：RV（-0.35升）为76%；FEV1（+10%）为57%；SGRQ（-4分）为87%；6MWD（+26米）为60%。