Treatment beyond inhalers : endoscopic lung volume reduction

printing supported by . Visit Chiesi at Stand D.30 TUESDAY, SEPTEMBER 27TH 2011 patients underwent a second treatment session after 12 weeks in the contralateral upper lobe to complete bilateral therapy. Pulmonary function, functional capacity, and quality of life assessments were performed at 3 and 6 months following treatment. Results: Upper lobe ELS therapy in this cohort (8 male, age 63±6 yrs) was associated with improvements in pulmonary function, functional capacity, and quality of life. Three (3) and 6 month improvements in FEV1 (+17.4±33.1%; 20.3±33.3%), FVC (11.3±24.7%; 12.3±24.2%), RV/TLC ratio (-7.5±11.1%; -6.2±7.4%), MRCD (-0.3±0.83U; -0.4±0.77U), 6MWT (+22.4±105.9m; +31.6±80.6m), and SGRQ (-9.5±11.3U; -6.3±9.6U) were reported. Clinically significant improvements in spirometry were observed in 9 of 14 patients at 6 month follow-up. Physiological responses were best in those patients (n=10) who received bilateral upper lobe split dose therapy ( FEV1 = +24.8±36.8%; FVC = +17.6±25.6%). Conclusions: ELS therapy in patients with advanced ULP emphysema improves lung function, functional capacity and quality of life out to at least 6 months. Improvements in spirometry following bilateral upper lobe therapy can be equivalent to those observed following lung volume reduction surgery. P3528 Physiological consequence of lower vs upper lobe lung volume reduction in patients with advanced emphysema Edward Ingenito, Larry Tsai. Pulmonary and Critical Care Medicine, Brigham and Women’s Hospital, Boston, MA, United States Objective(s): Lower lobe lung volume reduction in patients with advanced emphysema is associated with less benefit that upper lobe therapy. We present computer modeling results that explain these observations, and can help direct treatment site selection in patients undergoing lung volume reduction therapy. Methods: The model considers alveoli as discrete units with an exponential pressure-volume relationship of the form (V(Ptp) = Vmax – Ae-kPtp). Gravitational effects on transpulmonary pressure (Ptp), the extent of tissue destruction, airway closure effects, and extent of heterogeneity were incorporated as independent variables for predicting RV and RV/TLC. Results: Gravitational effects on Ptp are the major determinant of regional RV and overall RV/TLC. In upper lobe heterogeneous emphysema, changes in Ptp from volume reduction distend the remaining alveoli at end exhalation. However, RV and RV/TLC are reduced due to a decrease in the total number of diseased alveoli following treatment. In lower lobe heterogeneous emphysema, volume reduction distends already stretched upper lobe alveoli attenuating treatment effects on gas trapping. This phenomenon was more pronounced in homogeneous disease. Potential benefits of lower lobe volume reduction could be completely negated by upper lobe alveolar distention, resulting in no improvement, or even worsening of RV and RV/TLC despite alveolar resection. Conclusions: Gravitational effects largely explain why lower lobe volume reduction therapy is less therapeutic than upper lobe therapy. In patients with homogeneous emphysema, lower lobe therapy can actual worsen gas trapping despite resection of diseased tissue. P3529 Effect of fissure integrity on the efficacy of bronchoscopic lung volume reduction therapy using a peripheral acting tissue sealant in patients with advanced upper lobe predominant emphysema Helgo Magnussen1, Anne-Marie Kirsten1, Felix Herth2, Ralf Eberhardt2, Franz Stanzel3, Reiner Bonnet4, Juergen Behr5, Mordechai Kramer6. 1Zentrum for Pneumologie and Thoraxchirurgie, Pulmonary Research Institution, Krankenhaus Grosshansdorf, Grosshansdorf, Germany; 2Pneumology and Critical Care, Thoraxklinik University of Heidelberg, Heidelberg, Germany; 3Pneumology II and Endoscopy Service, Lungenklinik Hemer, Hemer, Germany; 4Pneumology, Zentralklinik Bad Berka GmbH, Bad Berka, Germany; 5Medizinischer Klinik III, University Bergmannsheil, Bochum, Germany; 6Pulmonary and Critical Care Medicine, Rabin Medical Center, Bellinson Hospital, Petach Tikva, Israel Objective(s): Results from the VENT Study (Sciurba F et al, NEJM 2010) indicate that endobronchial valve therapy is most effective in patients with upper lobe predominant heterogeneous (ULP) emphysema who have intact fissures. This study examines how fissure integrity affects the response to endobronchial volume reduction performed with the AeriSeal Emphysematous Lung Sealant System (ELS), a peripheral-acting tissue sealant. Methods: Lung volumes, tissue density, and disease heterogeneity were assessed by CT scanning in 27 patients (age 62.6±7.5 yrs, 19 male) with advanced ULP emphysema before and after ELS therapy. Post-treatment changes in lobar and total lung volumes were correlated with fissure integrity and with physiological, functional and quality of life outcomes out to 6 months. Results: ELS therapy reduced lobar volumes independent of fissure integrity. In ULP patients treated on the side of a complete fissure (n=12), lobar volume reduction was 530±323 mL, vs 406±330 mL on the side of an incomplete fissure (n=15; p=0.304). Improvements in pulmonary function (Complete vs Incomplete: FEV1 = +8.5% vs 8.9%), functional capacity ( MRCD = -1.1U vs -0.5U; 6MWD = +43.3m vs +41.0m), and quality of life ( SGRQ = -6.0U vs -7.9U) were similar in ULP patients with and without complete fissures although overall reductions in RV/TLC ( RV/TLC = -6.7% vs -1.8%) were greater in those with complete fissures. Conclusions: Fissure integrity had minimal impact on the overall response to endobronchial lung volume reduction therapy performed using ELS in patients with advanced ULP emphysema. P3530 Efficacy of bronchoscopic thermal vapor ablation and lobar fissure completeness Daniela Gompelmann1, Felix Herth1, Ralf Eberhardt1, Steven Kesten2, Claus Peter Heussel3. 1Pneumology and Critical Care Medicine, Thoraxklinik Heidelberg, Heidelberg, Germany; 2Clinical Department, Uptake Medical Corp, Tustin, CA, United States; 3Diagnostic and Interventional Radiology with Nuclear Medicine, Thoraxklinik Heidelberg, Heidelberg, Germany Background: Bronchoscopic thermal vapor ablation (BTVA) ablates emphysematous tissue through a localized inflammatory response followed by contractive fibrosis and atelectasis leading to permanent lung volume reduction that should not be influenced by collateral ventilation. Objectives: To determine the correlation of clinical data from a trial of BTVA to computed tomography (CT) assessment of fissure integrity. Methods: Single arm study (n= 44) of patients with heterogeneous upper lobe predominant emphysema with FEV1<45% predicted. Patients received BTVA to the RUL or LUL in a single setting. Primary efficacy outcomes: FEV1 and SGRQ at 6 months. Efficacy: lobar volume reduction (LoVR) from thin section multislice CT, spirometry, body plethysmography, 6MWD and mMRC dyspnea score. The treated lobar fissure was analyzed visually in non-enhanced pre-interventional CT. Incompleteness of small fissure, upper half of right large fissure, and three thirds of left large fissure were estimated in 5% increments and the relative amount of fissure incompleteness calculated. Pearson correlation coefficients were calculated for the association between fissure incompleteness and change in efficacy outcomes (baseline to 6 months). Results: Mean age 62 years, 50% men, FEV1 0.85 L (31% predicted), SGRQ 59 units, 6MWD 300m. Calculated relevant fissure incompleteness was 13% (median) (range 0-63%). 38/44 patients (86%) had incompleteness in the relevant fissure. Correlation coefficients (r) for the association of incompleteness to outcomes are as follows: FEV1 0.17, LoVR -0.27, SGRQ -0.10, 6MWD 0, RV -0.18, RV/TLC -0.14. Conclusion: BTVA induced LoVR and improvements in clinical outcomes are independent of fissure integrity. P3531 Associations of efficacy outcomes following bronchoscopic thermal vapor ablation (BTVA) for the treatment of heterogeneous emphysema Peter Hopkins1, Felix J.F. Herth2, Gregory Snell3 , Kim Baker4, Christian Witt5, Mark H. Gotfried6, Arschang Valipour7, Manfred Wagner8, Franz Stanzel9, Jim Egan10, Steven Kesten11, Armin Ernst12. 1Lung Transplant Unit, Prince Charles Hospital, Chermside, Australia; 2Pneumology and Critical Care Medicine, Thoraxklinik Heidelberg, Heidelberg, Germany; 3Allergy Immunology & Respiratory Medicine, The Alfred Hospital, Melbourne, Australia; 4Pulmonary and Critical Care Medicine, University of Iowa, Iowa City, IA, United States; 5Pneumology, Charité Campus-Mitte, Berlin, Germany; 6Pulmonary Associates, John C. Lincoln Hospital, Phoenix, AZ, United States; 7Ludwig-Boltzmann-Institute for COPD, Otto-Wagner-Hospital, Vienna, Austria; 8Pneumology, Klinikum Nürnberg, Nürnberg, Germany; 9Pneumologie, Zentrum für Pneumologie, Hemer, Germany; 10Advanced Lung Disease Program, Mater Misericordiae University Hospital, Dublin, Ireland; 11Clinical Department, Uptake Medical Corp, Tustin, CA, United States; 12Pulmonary Critical Care and Sleep Medicine, Caritas Ct. Elizabeth’s Medical Center, Boston, MA, United