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A Multicenter Rando...
A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM)
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- Kemp, Samuel V. (author)
- Royal Brompton Hosp, London; Imperial Coll London; Sherwood Forest Hosp NHS Fdn Trust, AshfieldAshfield
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- Slebos, Dirk-Jan (author)
- Univ Groningen, Univ Med Ctr Groningen, Dept Pulm Dis
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- Kirk, Alan (author)
- Golden Jubilee Natl Hosp, West Scotland Reg Heart & Lung Ctr, Dept Thorac Surg, West Dunbartonshire
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- Kornaszewska, Malgorzata (author)
- Univ Hosp Wales, Dept Cardiothorac Surg, Cardiff
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- Carron, Kris (author)
- AZ Delta, Dept Pulmonol, Menen
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- Ek, Lars (author)
- Skåne Univ Hosp, Dept Pulm Dis, Lund
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- Broman, Gustav (author)
- Uppsala universitet,Lung- allergi- och sömnforskning,Uppsala Univ Hosp, Dept Pulm Dis, Uppsala
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- Hillerdal, Gunnar (author)
- Uppsala Univ Hosp, Dept Pulm Dis, Uppsala
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- Mal, Herve (author)
- Hop Bichat Claude Bernard, Serv Pneumol A, Paris
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- Pison, Christophe (author)
- CHU Grenoble Alpes, Clin Univ Pneumol, Pole Thorax & Vaisseaux, Grenoble
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- Briault, Amandine (author)
- CHU Grenoble Alpes, Clin Univ Pneumol, Pole Thorax & Vaisseaux, Grenoble
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- Downer, Nicola (author)
- Sherwood Forest Hosp NHS Fdn Trust, Ashfield
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- Darwiche, Kaid (author)
- Univ Clin Essen, Dept Intervent Pneumol, West German Lung Ctr, Ruhrlandklin, Essen
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- Rao, Jagan (author)
- Sheffield Teaching Hosp NHS Fdn Trust, Sheffield, S Yorkshire
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- Huebner, Ralf-Harto (author)
- Charite, Medi Klin M Schw Infektiol & Pneumol, Campus Virchow, Berlin
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- Ruwwe-Glosenkamp, Christof (author)
- Charite, Medi Klin M Schw Infektiol & Pneumol, Campus Virchow, Berlin
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- Trosini-Desert, Valery (author)
- Grp Hosp Pitie Salpetriere, Unite Endoscopie Bronch, Serv Pneumol & Reanimat, Paris
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- Eberhardt, Ralf (author)
- Heidelberg Univ, Dept Pneumol & Crit Care Med, Thoraxklin, Heidelberg; Translat Lung Res Ctr Heidelberg, Heidelberg
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- Herth, Felix J. (author)
- Heidelberg Univ, Dept Pneumol & Crit Care Med, Thoraxklin, Heidelberg; Translat Lung Res Ctr Heidelberg, Heidelberg
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- Derom, Eric (author)
- Ghent Univ Hosp, Dept Pulm Dis, Ghent
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- Malfait, Thomas (author)
- Ghent Univ Hosp, Dept Pulm Dis, Ghent
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- Shah, Pallav L. (author)
- Royal Brompton Hosp, London; Imperial Coll London
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- Garner, Justin L. (author)
- Royal Brompton Hosp, London; Imperial Coll London
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- ten Hacken, Nick H. (author)
- Univ Groningen, Univ Med Ctr Groningen, Dept Pulm Dis
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- Fallouh, Hazem (author)
- Univ Hosp Wales, Dept Cardiothorac Surg, Cardiff
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- Leroy, Sylvie (author)
- Univ Cote Azur, CHU Nice, Serv Pneumol, FHU OncoAge, Nice
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- Marquette, Charles H. (author)
- Univ Cote Azur, CHU Nice, Serv Pneumol, FHU OncoAge, Nice
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(creator_code:org_t)
- AMER THORACIC SOC, 2017
- 2017
- English.
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In: American Journal of Respiratory and Critical Care Medicine. - : AMER THORACIC SOC. - 1073-449X .- 1535-4970. ; 196:12, s. 1535-1543
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- Rationale: Single-center randomized controlled trials of the Zephyr endobronchial valve (EBV) treatment have demonstrated benefit in severe heterogeneous emphysema. This is the first multicenter study evaluating this treatment approach. Objectives: To evaluate the efficacy and safety of Zephyr EBVs in patients with heterogeneous emphysema and absence of collateral ventilation.Methods: This was a prospective, multicenter 2:1 randomized controlled trial of EBVs plus standard of care or standard of care alone (SoC). Primary outcome at 3 months post-procedure was the percentage of subjects with FEV1 improvement from baseline of 12% or greater. Changes in FEV1, residual volume, 6-minute-walk distance, St. George's Respiratory Questionnaire score, and modified Medical Research Council score were assessed at 3 and 6 months, and target lobe volume reduction on chest computed tomography at 3 months.Measurements and Main Results: Ninety seven subjects were randomized toEBV(n = 65) or SoC(n = 32). At 3 months, 55.4% of EBV and 6.5% of SoC subjects had an FEV1 improvement of 12% or more (P < 0.001). Improvements were maintained at 6 months: EBV 56.3% versus SoC 3.2% (P < 0.001), with a mean +/- SD change in FEV1 at 6 months of 20.7 +/- 29.6% and -8.6 +/- 13.0%, respectively. A total of 89.8% of EBV subjects had target lobe volume reduction greater than or equal to 350 ml, mean 1.09 +/- 0.62 L (P < 0.001). Between-group differences for changes at 6 months were statistically and clinically significant: Delta EBV-SoC for residual volume, -700 ml; 6-minute-walk distance, +78.7 m; St. George's Respiratory Questionnaire score, -6.5 points; modified Medical Research Council dyspnea score, -0.6 points; and BODE(body mass index, airflow obstruction, dyspnea, and exercise capacity) index, 21.8 points (all P < 0.05). Pneumothorax was the most common adverse event, occurring in 19 of 65 (29.2%) of EBV subjects.Conclusions: EBV treatment in hyperinflated patients with heterogeneous emphysema without collateral ventilation resulted in clinically meaningful benefits in lung function, dyspnea, exercise tolerance, and quality of life, with an acceptable safety profile.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Lungmedicin och allergi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Respiratory Medicine and Allergy (hsv//eng)
Keyword
- endobronchial valves
- lung volume reduction
- collateral ventilation
- hyperinflation
- chronic obstructive pulmonary disease
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Kemp, Samuel V.
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Slebos, Dirk-Jan
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Kirk, Alan
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Kornaszewska, Ma ...
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Carron, Kris
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Ek, Lars
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show more...
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Broman, Gustav
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Hillerdal, Gunna ...
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Mal, Herve
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Pison, Christoph ...
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Briault, Amandin ...
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Downer, Nicola
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Darwiche, Kaid
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Rao, Jagan
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Huebner, Ralf-Ha ...
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Ruwwe-Glosenkamp ...
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Trosini-Desert, ...
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Eberhardt, Ralf
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Herth, Felix J.
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Derom, Eric
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Malfait, Thomas
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Shah, Pallav L.
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Garner, Justin L ...
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ten Hacken, Nick ...
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Fallouh, Hazem
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Leroy, Sylvie
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Marquette, Charl ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Respiratory Medi ...
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American Journal ...
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Uppsala University