Background Since successful development of endobronchial valves (EBV) as treatment for severe emphysema, its main complication, pneumothorax, remains an important concern. Objective We hypothesized that a two-step EBV implantation, during two distinct iterative procedures could lead to a more progressive target lobe volume reduction (TLVR) and thus ipsilateral lobe re-expansion, resulting in a significant decrease in the pneumothorax rate. Methods This retrospective bi-center study carried out by Limoges and Toulouse University Hospitals included patients following the inclusion criteria established by the BLVR expert panel. All patients were treated by two distinct procedures: first, EBVs were placed in all but the most proximal segment or sub-segment. The remaining segment was treated subsequently. All patients had a complete evaluation before treatment, and 3 months after the second procedure. Results Out of 58 patients included, only 4 pneumothoraxes (7%) occurred during the study. The other complications were pneumonia and severe COPD exacerbation (8.6% and 13.7% of patients, respectively). Significant improvement was found for FEV 1 (+19.6 ± 25%), RV (−468 ± 960mL), 6MWD (30 ± 85m), BODE Index (−1.4 ± 1.8 point) and TLVR (50.6 ± 35.1%). Significant TLVR (MCID) was obtained in 74.1% of patients (43/58). Conclusion This new approach using EBV could reduce the incidence of pneumothorax without increasing other complication rates. Clinical and physiological outcomes are similar to those reported in studies using the conventional single-step treatment.
Background and Objective Dynamic hyperinflation (DH) is a major marker of exertional dyspnoea in severe emphysema. We hypothesized that bronchoscopic lung volume reduction (BLVR) using endobronchial valves (EBVs) decreases DH. Methods In this prospective bi‐centre study from both Toulouse and Limoges Hospitals, we assessed DH during an incremental cycle ergometry before and 3 months after EBVs treatment. The primary objective was to observe the change in inspiratory capacity (IC) at isotime. Target lobe volume reduction (TLVR) and changes in residual volume (RV), forced expiratory volume in one‐second (FEV1), mMRC, 6 minutes walking distance (6MWD), BODE and other dynamic measures like tele‐expiratory volume (EELV) were also analysed. Results Thirty‐nine patients were included, of whom thirty‐eight presented DH. IC and EELV at isotime significantly improved (+214 mL, p = 0.004; −713 mL, p ˂ 0.001, respectively). Mean changes were +177 mL for FEV1 (+19%, p < 0.001), −600 mL for RV (p < 0.0001), +33 m for 6MWD (p < 0.0001), respectively. Patients who responded on RV (>430 mL decrease) and FEV1 (>12% gain) had better improvements compared to non‐responders (+368 mL vs. +2 mL; +398 mL vs. −40 mL IC isotime, respectively). On the opposite, in patients who responded on DH (>200 mL IC isotime increase), changes in TLV (−1216 mL vs. −576 mL), FEV1 (+261 mL vs. +101 mL), FVC (+496 mL vs. +128 mL) and RV (−805 mL vs. −418 mL) were greater compared to non‐responders. Conclusions DH decreases after EBVs treatment, and this improvement is correlated with static changes.
BackgroundIn the context of personalized medicine, screening patients to identify targetable molecular alterations is essential for therapeutic decisions such as inclusion in clinical trials, early access to therapies, or compassionate treatment. The objective of this study was to determine the real-world impact of routine incorporation of FoundationOne analysis in cancers with a poor prognosis and limited treatment options, or in those progressing after at least one course of standard therapy.MethodsA FoundationOneCDx panel for solid tumor or liquid biopsy samples was offered to 204 eligible patients.ResultsSamples from 150 patients were processed for genomic testing, with a data acquisition success rate of 93%. The analysis identified 2419 gene alterations, with a median of 11 alterations per tumor (range, 0–86). The most common or likely pathogenic variants were on TP53, TERT, PI3KCA, CDKN2A/B, KRAS, CCDN1, FGF19, FGF3, and SMAD4. The median tumor mutation burden was three mutations/Mb (range, 0–117) in 143 patients with available data. Of 150 patients with known or likely pathogenic actionable alterations, 13 (8.6%) received matched targeted therapy. Sixty-nine patients underwent Molecular Tumor Board, which resulted in recommendations in 60 cases. Treatment with genotype-directed therapy had no impact on overall survival (13 months vs. 14 months; p = 0.95; hazard ratio = 1.04 (95% confidence interval, 0.48–2.26)].ConclusionsThis study highlights that an organized center with a Multidisciplinary Molecular Tumor Board and an NGS screening system can obtain satisfactory results comparable with those of large centers for including patients in clinical trials.
Background: As the endobronchial valves (EBV) were successfully developed as treatment for severe emphysema, its main complication, Pneumothorax, remained an important concern.Objective: To assess whether the placement throughout 2 procedures instead of 1 of Zephyr endobronchial valves minor the frequency of pneumothorax without lowering the benefits of such treatment. Methods: This retrospective study was conducted on selected patients presenting a severe emphysema meeting the criteria stated by the GOLD society. They were all treated and followed at the Limoges University Hospital. They received all but one EBV during a first procedure, leaving the most proximal sub-segment of the treated lobe open. The last valve was positioned 1 month after during a 2 nd procedure. All patients were evaluated before, between and after the procedures. Results: 22 patients received EBV treatment. The median delay between the 2 procedures were 28 days. A median of 5 valves (3 to 8) per subject were implanted. Only 1 patient (4,5%) presented a pneumothorax. It was after the 2 nd procedure and required a chest tube, that was removed after a week. No valves had to be removed. Beside pneumothorax, the main adverse events were exacerbation (13%) and valves expectoration (4%). Except for this pneumothorax, there was only one hospitalization for another side effect: It was a pneumonia distal to valve and it resolved after antibiotics therapy. No deaths were reported. Significant improvement was found for FEV1 (16.6 ± 19.8%), RV (-0.45 ± 0.63 L), 6MWT (58 ± 55m), BODE Score (-3,6 ± 1,5 points) and mMRC scale (-0,7 +/_ 0,7 point). 2 different patterns of evolution seem to emerge, based on the evolution of the BODE score: the patients reaching the BODE MCID criteria at the 1st procedure, also presented a statistically higher improvement of their FEV1 (p=0.005) and mMRC score (p=0.001). This subgroup of patients also improved significantly from baseline to the 2 evaluation their FEV1 (34% vs 8.5%, p=0.01) and RV (-56.4 vs -31.5, p=0.04). The frequency of atelectasis on the CT scan after the 1st post procedure was also higher in this group (71% vs 14%, p=0,03). No predictive baseline characteristic seems to emerge.Conclusion: Placing EBV during 2 procedures instead of one led to a significant decrease of post treatment pneumothoraxes without a significant impact on other complications. It does not alter the benefits of such therapy for severe emphysema.
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