5359.ppt

R Eberhardt Thoraxklinik am Universitätsklinikum Heidelberg

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Bronchoscopic lung-volume reductionBronchoscopic lung-volume reduction in patients with severe homogeneous in patients with severe homogeneous

emphysemaemphysema

R Eberhardt1, CP Heußel1, A Ernst2, FJF Herth1

1Thoraxklinik am Universitätsklinikum HeidelbergInternistische Onkologie der Thoraxtumoren – Thoraxchirurgie

2Interventional Pulmonology, Beth Israel Deaconess Medical CenterHarvard Medical School - Boston, US

ERS Stockholm 2007


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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.“


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Fishman A et al. NETT Research Group, N Eng J Med 2003

LVRS


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National Emphysema Treatment National Emphysema Treatment Trial 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


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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 2005Wan IY et al. Chest. 2006

BLVR


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Bronchoscopic lung-volume reduction Bronchoscopic lung-volume reduction in patients with homogeneous in patients with homogeneous

emphysemaemphysema► 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


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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



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► 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



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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)



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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



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Changes in lung-function Changes in lung-function and exercising toleranceand exercising tolerance

no major changing in lung function

a trend toward improvement in 6MWT



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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



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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



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all domains showed a decrease from baseline

signifcant improvements in impacts and activity and also total score



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small but positive improvements across a range of variables measured

changes are consistent with this hypothesized mechanism of BLVR



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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



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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



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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



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„„Thank you for your attention … !“Thank you for your attention … !“[email protected]

ERS Stockholm 2007


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Backup slides – graphic plus associated data table


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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

% C

ha

ng

e f

rom

Ba

se

line

30 days 90 days


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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


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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

5359.ppt

Health & Medicine

r eberhardt thoraxklinik

mwt blvr homogeneous

overall lung volume

advanced emphysema

patients lul

patients rll

exspiratory volume

homogeneous emphysemapatients