1
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
Bronchoscopic lung-volume reductionBronchoscopic lung-volume...
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
LVRS
Lung-volume Reduction SurgeryLung-volume Reduction Surg...
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
Fishman A et al. NETT Research Group, N Eng J Med 2003
LVRS
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
National Emphysema Treatment TrialNational Emphysema Treatme...
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
Bronchoscopic lung-volume reductionBronchoscopic lung-volume...
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
Bronchoscopic lung-volume reduction inBronchoscopic lung-vol...
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
MethodsMethods
► Unilateral bronchoscopic LVR
► valve placem...
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
► Lung function
► forced exspiratory volume in 1 second (FEV...
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
Patients pre-procedurePatients pre-procedure
► 07/2006 -01/2...
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
Valve placementValve placement
RUL: 3 patients LUL: 3 patien...
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
Changes in lung-functionChanges in lung-function
and exercis...
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
 the MCID threshold for
this instrument is 4 points
 the t...
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
St. Georges Respiratory QuestionaireSt. Georges Respiratory ...
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
St. Georges Respiratory QuestionaireSt. Georges Respiratory ...
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
St. Georges Respiratory QuestionaireSt. Georges Respiratory ...
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
ComplicationsComplications
►1 pneumothorax
►no chest tube ne...
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
LimitationsLimitations
►small number of patients
►no control...
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
ConclusionsConclusions
► Valve placement in patients with ho...
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
„„Thank you for your attention … !“Thank you for your attent...
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
Backup slides – graphic plus associated data table
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
Mean Change in PFT Values
-10.0%
-5.0%
0.0%
5.0%
10.0%
15.0%...
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
SGRQ: Mean Change Score from Baseline
-15.76
-12.38
-14.44
-...
R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg
.
SGRQ: Percent of Patients
Meeting 4 Point Decrease Threshold...
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  • this overall improvement was driven by improvements in the impacts and activity domains
  • In addition to mean change, we analyzed the proportion of patients meeting the 4 point MCID threshold for improvement
    More than half of subjects met this threshold for many of the domains at multiple timepoints
    For the Total SGRQ score, 60% of patients met the threshold at the 90 day follow-up
  • In addition to mean change, we analyzed the proportion of patients meeting the 4 point MCID threshold for improvement
    More than half of subjects met this threshold for many of the domains at multiple timepoints
    For the Total SGRQ score, 60% of patients met the threshold at the 90 day follow-up
  • Small but positive improvements were noted across a range of variables measured
    The observed directional changes are consistent with this hypothesized mechanism of action
    FEV1 and FVC increased RV and TLC volumes decreased Exercise tolerance improved
  • This small, pilot study confirmed the technical feasibility and general safety of using Bronchial Valve Therapy to treat patients with more homogeneous emphysema
    Given studies to date have focused on patients with heterogeneous disease distribution, this study represents an important early investigation into to application of this new therapy to treat additional patient populations
    Data from this series patients showed a consistent and clinically meaningful improvement in quality of life as measured by the SGRQ
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  • 5359.ppt

    1. 1. 1
    2. 2. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . Bronchoscopic lung-volume reductionBronchoscopic lung-volume reduction in patients with severe homogeneousin patients with severe homogeneous emphysemaemphysema R Eberhardt1 , CP Heußel1 , A Ernst2 , FJF Herth1 1 Thoraxklinik am Universitätsklinikum Heidelberg Internistische Onkologie der Thoraxtumoren – Thoraxchirurgie 2 Interventional Pulmonology, Beth Israel Deaconess Medical Center Harvard Medical School - Boston, US ERS Stockholm 2007
    3. 3. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . LVRS Lung-volume Reduction SurgeryLung-volume Reduction Surgery ► Brantigan OC Ann Surg 1957: „ …reducing overall lung volume … would restore the outware elastic pull on the small airways and reduce exspiratory airway obstruction.“ ► Cooper JD et al. J Thorac Cardiovasc Surg 1996 „Results of 150 consecutive bilateral lung volume reduction procedures in patients with severe emphysema.“
    4. 4. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . Fishman A et al. NETT Research Group, N Eng J Med 2003 LVRS
    5. 5. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . National Emphysema Treatment TrialNational Emphysema Treatment Trial „ … advantage for patients with both predominantly upper-lobe emphysema … !“ „Patients […] with non-upper-lobe emphysema […] are poor candidates for lung-volume reduction surgery, … !“ Fishman A et al. NETT Research Group, N Eng J Med 2003 LVRS
    6. 6. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . Bronchoscopic lung-volume reductionBronchoscopic lung-volume reduction ► Bronchial valve therapy is a new treatment option  patients with advanced emphysema  since 2003 ► Different devices on the market ► Pilot studies have suggested improvement in patients  lung function  exercise tolerance ► Studies have focused on patients with heterogeneous disease distribution Toma TP et al. Lancet. 2003 Venuta F et al. Ann Thorac surg 2005 Wan IY et al. Chest. 2006 BLVR
    7. 7. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . Bronchoscopic lung-volume reduction inBronchoscopic lung-volume reduction in patients with homogeneous emphysemapatients with homogeneous emphysema ► Prospective study design  proof of principle and safety ► Severe emphysema  FEV1 < 45 %  RV > 150% ► Homogeneous emphysema distribution  confirmed by CT-Scan analysis  software Yacta®, Mainz, Germany BLVR – homogeneous emphysema
    8. 8. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . MethodsMethods ► Unilateral bronchoscopic LVR ► valve placement ► Zephyr® Endobronchial Valve Emphasys Medical™, Redwood City, USA ► Occlusion of one lobe completely ► Selection by nuclear scintigraphy ► lowest perfusion ► Follow UP ► after 30 days ► after 90 days BLVR – homogeneous emphysema
    9. 9. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . ► Lung function ► forced exspiratory volume in 1 second (FEV1) ► vital capacity (VC) ► residual volume (RV) ► total lung capacity (TLC) ► Exercising tests ► 6 minute walk test (6MWT) ► cycle ergometrie ► Quality of life (QoL) ► SGRQ MethodsMethods BLVR – homogeneous emphysema
    10. 10. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . Patients pre-procedurePatients pre-procedure ► 07/2006 -01/2007 ► 10 patients  5 female, 5 male  60.2 years mean age ► lung function  FEV1 0.93 l (range 0.55-1.35)  RV 5,23 l (range 3.55- 8.24) ► exercising tests  6MWT 325 m (range 150-480) BLVR – homogeneous emphysema
    11. 11. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . Valve placementValve placement RUL: 3 patients LUL: 3 patients RLL: 1 patient LLL: 3 patients  overall 3.8 valves/patient (range 2 to 6)  with flexible bronchoscopy  under general anaesthesia 3.7 valves/patient 3.7 valves/patient 3.0 valves/patient 4.3 valves/patient BLVR – homogeneous emphysema
    12. 12. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . Changes in lung-functionChanges in lung-function and exercising toleranceand exercising tolerance  no major changing in lung function  a trend toward improvement in 6MWT BLVR – homogeneous emphysema
    13. 13. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg .  the MCID threshold for this instrument is 4 points  the total SGRQ score decreases > 4 points  increased symptoms score St. Georges Respiratory QuestionaireSt. Georges Respiratory Questionaire BLVR – homogeneous emphysema
    14. 14. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . St. Georges Respiratory QuestionaireSt. Georges Respiratory Questionaire  proportion of patients meeting the 4 point MCID threshold for improvement  more than half of subjects met this threshold  confirmation of the clinical benefit in 7 patients BLVR – homogeneous emphysema
    15. 15. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . St. Georges Respiratory QuestionaireSt. Georges Respiratory Questionaire  all domains showed a decrease from baseline  signifcant improvements in impacts and activity and also total score BLVR – homogeneous emphysema
    16. 16. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . St. Georges Respiratory QuestionaireSt. Georges Respiratory Questionaire  small but positive improvements across a range of variables measured  changes are consistent with this hypothesized mechanism of BLVR BLVR – homogeneous emphysema
    17. 17. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . ComplicationsComplications ►1 pneumothorax ►no chest tube necessary ►patient was discharged after 4 days ►1 removal after 90 days ►caused by recurrent infections ►no severe adverse event ►no bleeding ►no pneumonia BLVR – homogeneous emphysema
    18. 18. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . LimitationsLimitations ►small number of patients ►no control group ►QoL measures are more subject to plazebo effect ►Selection of different lobes will maybe an independent factor for outcome BLVR – homogeneous emphysema
    19. 19. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . ConclusionsConclusions ► Valve placement in patients with homogeneous emphysema is  technical feasible  safe ► Consistent and clinically improvement in quality of life as measured by the SGRQ ► Small improvements in PFT and exercise tolerance are consistent with the proposed mechanism of LVR ► New therapy to treat this additional patient populations (?)  in contrast to lung-volume reduction surgery  need of additional selection criteria gained by VENT study ► Further clinical investigations are warranted BLVR – homogeneous emphysema
    20. 20. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . „„Thank you for your attention … !“Thank you for your attention … !“ ralf.eberhardt@thoraxklinik-heidelberg.de ERS Stockholm 2007
    21. 21. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . Backup slides – graphic plus associated data table
    22. 22. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . Mean Change in PFT Values -10.0% -5.0% 0.0% 5.0% 10.0% 15.0% 20.0% FEV1 FVC RV TLC 6MWT CYCLE %ChangefromBaseline 30 days 90 days
    23. 23. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . SGRQ: Mean Change Score from Baseline -15.76 -12.38 -14.44 -2.42 -6.54 -9.14 -5.19 -1.46 -20 -15 -10 -5 0 5 Total Score Impacts Activity Symptoms 30 day 90 day
    24. 24. R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg . SGRQ: Percent of Patients Meeting 4 Point Decrease Threshold 75% 60% 75% 29% 60% 80% 60% 29% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% Total Impacts Activity Symptoms 30 Day 90 Day

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