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.
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| http://dx.doi.org/10.21037/jtd.2018.04.53 | DOI Listing |
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