Diagnostic performance comparison of the Chartis System and high-resolution computerized tomography fissure analysis for planning endoscopic lung volume reduction.

BACKGROUND AND OBJECTIVE: Endobronchial valve (EBV) therapy is optimized in patients who demonstrate little or no collateral ventilation (CV). The accuracy of the Chartis System and visual assessment of high-resolution computerized tomography (HRCT) fissure completeness by a core radiology laboratory for classifying CV status was compared by evaluating the relationship of each method with target lobe volume reduction (TLVR) after EBV placement. METHODS: Retrospective HRCT fissure analysis of a study population who underwent catheter-based measurement of CV followed by complete occlusion of the targeted lobe by EBV. Accuracy, sensitivity, specificity, positive predictive value and negative predictive value of the HRCT fissure analysis and the catheter-based measurement of CV for predicting TLVR was determined. RESULTS: Accuracy for correctly classifying TLVR with EBV was similar for Chartis System and HRCT fissure analysis (74 vs 77%). The sensitivity and specificity of the Chartis measurement were 86% and 61% and those of HRCT fissure analysis 75% and 79%. Patients with TLVR ≥ 350 mL had statistically significant improvement in respiratory function, exercise performance and quality of life measures. CONCLUSIONS: When evaluating patients for likelihood of successful EBV therapy, the Chartis System CV assessment and HRCT fissure analysis appear to have comparable accuracy. Both techniques were found to be beneficial for EBV procedure planning.

Efficacy predictors of lung volume reduction with Zephyr valves in a European cohort.

The Endobronchial Valve for Emphysema Palliation Trial (VENT) was a multi-centre, prospective, randomised, controlled trial conducted to evaluate the safety and effectiveness of unilateral endobronchial valve (EBV) treatment. The purpose of this analysis was to assess outcomes in the previously unreported European VENT study cohort. Patients with advanced emphysema were randomly assigned (2:1) to receive Zephyr® (Pulmonx Inc., Redwood City, CA, USA) EBV treatment (n = 111) or medical management (n = 60). At 6 months, EBV patients demonstrated a significant improvement compared with the controls for mean ± SD change in forced expiratory volume in 1 s (7 ± 20% versus 0.5 ± 19%; p = 0.067), cycle ergometry (2 ± 14 W versus -3 ± 10 W; p = 0.04) and St George's Respiratory Questionnaire (-5 ± 14 points versus 0.3 ± 13 points; p = 0.047). At 12 months, the magnitude of the difference between groups for change from baseline was of similar magnitude to the differences seen at 6 months. Rates for complications did not differ significantly. EBV patients with computed tomography (CT) scans suggestive of complete fissure and lobar occlusion had a mean ± SD lobar volume reduction of -80 ± 30% and >50% met minimal clinical difference thresholds. The degree of emphysema heterogeneity did not preclude excellent outcomes. Unilateral lobar volume reduction using EBV treatment is safe and superior clinical results correlated with CT suggestive of complete fissures and successful lobar occlusion. Emphysema heterogeneity was not critical for determining positive outcomes.

Risk factors for self-reported visual symptoms with Intacs inserts for myopia.

OBJECTIVE: Potential risk factors and visual performance measures were evaluated for relationship to self-report of clinical visual symptoms after the refractive procedure for placement of Intacs microthin prescription inserts for myopia. DESIGN: Retrospective nonrandomized comparative study. PARTICIPANTS/INTERVENTION: Patients were participants in the U.S. Food and Drug Administration phase III KeraVision prospective clinical trials. MAIN OUTCOME MEASURES: Study participants (n = 263) were retrospectively classified into one of three outcome groups on the basis of postoperative self-reported visual symptoms and/or request for Intacs inserts removal through month 24. Differences between outcome groups in visual acuity, refractive error, corneal geometry, corneal topography, type of preoperative corrective lens wear, and demographic variables were evaluated with multivariate logistic regression. RESULTS: Clinical trial participants who had preoperative mean keratometry >45 diopters (D) (adjusted odds ratio [OR], 0.43; 95% confidence interval [CI], 0.21, 0.85, P = 0.02), manifest refractive astigmatism of 0.75 D or 1.00 D (adjusted OR, 0.52; 95% CI, 0.25, 1.08, P = 0.08), measured uncorrected visual acuity > or =2 lines better than that predicted by their respective cycloplegic refractive error (adjusted OR, 0.39; 95% CI, 0.14, 1.12, P = 0.08) and/or had worn soft contact lenses (adjusted OR, 0.58; 95% CI, 0.32, 1.04, P = 0.07) tended to be less likely to report postoperative clinical visual symptoms with Intacs inserts. Risk of clinical visual symptoms and request for Intacs inserts removal approximately doubled for each 0.50 D of additional postoperative defocus equivalent (crude OR, 1.86; 95% CI, 1.39, 2.48, P = 0.00). Controlling for postoperative defocus and important preoperative risk factors, subjects who reported significant clinical visual symptoms were more likely to have had preoperative uncorrected visual acuity that was worse than that predicted by their respective cycloplegic refractive error (adjusted OR, 1.84; 95% CI, 0.98, 3.42, P = 0.06). Risk of reporting clinical visual symptoms was increased with mesopic pupil diameter > or =6.5 mm (adjusted OR, 1.76; 95% CI, 0.96, 3.24, P = 0.07). Within the group of patients who reported postoperative clinical visual symptoms, 71 of 122 (58%) had ceased reporting them by month 24. CONCLUSIONS: Adjusting for important risk factors simultaneously, this study suggested that certain preoperative characteristics may increase or decrease the likelihood, depending on the characteristic, of refractive surgery candidates to report significant clinical visual symptoms with Intacs inserts.