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A multicenter randomized controlled trial of Zephyr endobronchial valve treatment in heterogeneous emphysema (TRANSFORM)

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Abstract
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.
Keywords
LUNG-VOLUME-REDUCTION, INTERLOBAR COLLATERAL VENTILATION, OBSTRUCTIVE, PULMONARY-DISEASE, MINIMAL IMPORTANT DIFFERENCE, FOLLOW-UP, CLINICAL-OUTCOMES, BELIEVER-HIFI, SURGERY, THERAPY, COPD, endobronchial valves, lung volume reduction, collateral ventilation, hyperinflation, chronic obstructive pulmonary disease

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MLA
Kemp, Samuel V, Dirk-Jan Slebos, Alan Kirk, et al. “A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM).” AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE 196.12 (2017): 1535–1543. Print.
APA
Kemp, S. V., Slebos, D.-J., Kirk, A., Kornaszewska, M., Carron, K., Ek, L., Broman, G., et al. (2017). A multicenter randomized controlled trial of Zephyr endobronchial valve treatment in heterogeneous emphysema (TRANSFORM). AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, 196(12), 1535–1543.
Chicago author-date
Kemp, Samuel V, Dirk-Jan Slebos, Alan Kirk, Malgorzata Kornaszewska, Kris Carron, Lars Ek, Gustav Broman, et al. 2017. “A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM).” American Journal of Respiratory and Critical Care Medicine 196 (12): 1535–1543.
Chicago author-date (all authors)
Kemp, Samuel V, Dirk-Jan Slebos, Alan Kirk, Malgorzata Kornaszewska, Kris Carron, Lars Ek, Gustav Broman, Gunnar Hillerdal, Herve Mal, Christophe Pison, Amandine Briault, Nicola Downer, Kaid Darwiche, Jagan Rao, Ralf-Harto Huebner, Christof Ruwwe-Glosenkamp, Valery Trosini-Desert, Ralf Eberhardt, Felix J Herth, Eric Derom, Thomas Malfait, Pallav L Shah, Justin L Garner, Nick H ten Hacken, Hazem Fallouh, Sylvie Leroy, and Charles H Marquette. 2017. “A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM).” American Journal of Respiratory and Critical Care Medicine 196 (12): 1535–1543.
Vancouver
1.
Kemp SV, Slebos D-J, Kirk A, Kornaszewska M, Carron K, Ek L, et al. A multicenter randomized controlled trial of Zephyr endobronchial valve treatment in heterogeneous emphysema (TRANSFORM). AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE. 2017;196(12):1535–43.
IEEE
[1]
S. V. Kemp et al., “A multicenter randomized controlled trial of Zephyr endobronchial valve treatment in heterogeneous emphysema (TRANSFORM),” AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, vol. 196, no. 12, pp. 1535–1543, 2017.
@article{8554130,
  abstract     = {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.},
  author       = {Kemp, Samuel V and Slebos, Dirk-Jan and Kirk, Alan and Kornaszewska, Malgorzata and Carron, Kris and Ek, Lars and Broman, Gustav and Hillerdal, Gunnar and Mal, Herve and Pison, Christophe and Briault, Amandine and Downer, Nicola and Darwiche, Kaid and Rao, Jagan and Huebner, Ralf-Harto and Ruwwe-Glosenkamp, Christof and Trosini-Desert, Valery and Eberhardt, Ralf and Herth, Felix J and Derom, Eric and Malfait, Thomas and Shah, Pallav L and Garner, Justin L and ten Hacken, Nick H and Fallouh, Hazem and Leroy, Sylvie and Marquette, Charles H},
  issn         = {1073-449X},
  journal      = {AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE},
  keywords     = {LUNG-VOLUME-REDUCTION,INTERLOBAR COLLATERAL VENTILATION,OBSTRUCTIVE,PULMONARY-DISEASE,MINIMAL IMPORTANT DIFFERENCE,FOLLOW-UP,CLINICAL-OUTCOMES,BELIEVER-HIFI,SURGERY,THERAPY,COPD,endobronchial valves,lung volume reduction,collateral ventilation,hyperinflation,chronic obstructive pulmonary disease},
  language     = {eng},
  number       = {12},
  pages        = {1535--1543},
  title        = {A multicenter randomized controlled trial of Zephyr endobronchial valve treatment in heterogeneous emphysema (TRANSFORM)},
  url          = {http://dx.doi.org/10.1164/rccm.201707-1327OC},
  volume       = {196},
  year         = {2017},
}

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