Abstract
Objective: Aim of this prospective, nonrandomized, exploratory, single center, first-in-man study was to evaluate the feasibility and safety of the CinensesTM LVR-R System.
Methods: 9 patients (♂/♀:5/4, 63±6years, 44±14 package years) have been treated so far. At 6 months follow-up changes in pulmonary function tests (PFT), 6MWT, mMRC dyspnea scale and CAT score, as well as possible complications were recorded.
Results: This study was not powered to measure any statistical differences in endpoints. FEV1 (27,10±4,53% vs 29,34±12,64%), VC (71,57±20,65% vs 67,12±21,31%) and RV (236,27±28,36% vs 244,71±37,80%) none showed significant improvement. 6MWT (328±75m vs 299±102m), mMRC (2,78±1,3 vs 2,11±1,3) and CAT score (25,44±9,38 vs 26,75±9,38) similarly did not improve significantly.
Significant complications included 12 pneumonia incidents in 7 patients treated with intravenous (iv) antibiotics, 4 COPD exacerbations requiring iv cortison therapy in 3 patients, a pneumothorax requiring chest–tube draining in 1 patient. Furthermore, 2 patients required a non-invasive ventilation by ventilatory failure and 2 patients were hospitalized due to hemoptysis without need of surgical intervention. All patients had light, self-limited hemoptysis. Pneumonia or COPD exacerbation requiring only oral antibiotics and/or cortison in 4 patients.
Conclusions: LVR-R implantation was feasible but this small patient group did not show significant improvement in PFTs, 6MWT, mMRC or CAT score. A significant complication rate mainly due to pneumonias was noted. These results have to be further confirmed in larger-scale controlled studies.
Footnotes
Cite this article as: European Respiratory Journal 2021; 58: Suppl. 65, PA3799.
This abstract was presented at the 2021 ERS International Congress, in session “Prediction of exacerbations in patients with COPD”.
This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).
- Copyright ©the authors 2021