Coil Technology Clinical Evidence

The Coil technology has been studied in Europe since 2012. Here is a summary of relevant publications:

PublicationTherapyNResultsConclusions
ELEVATE Randomized controlled trial

Klooster et al (19)
Coil treatment group and optimal medical therapy57At 6 months, analysis showed significantly greater improvement in favor of the coil group, with the following changes:

• SGRQ score: −8.6±4 and +2.1±3.5 points (P=0.001)

• FEV1: +7.9±5% versus a loss of -3.2±3% (P=0.001)
Coil treatment compared to control results in an improvement in lung function and quality-of-life benefits for up to 6 months in patients with emphysema and severe hyperinflation.
Optimal medical therapy34
RESET Randomized controlled trial

Shah et al (3)
Zoumet et al (6)
Coil treatment group and optimal medical therapy23At 6 and 12 months, respectively, significant improvements were observed in all outcome measures in the coil treatment group, with the following changes:
• SGRQ score: −7±12 and −6±14 points (P=0.01)
• 6MWD: +55±54 and +34±52 m (P=0.005)
• FEV1: +10±21% and +9±22% (P=0.002)
• FVC: +10±18% and +8±16% (P=0.004)
• RV: −0.34±0.8 L and −0.32±0.8 L (P=0.02)
Statistically and clinically meaningful benefits in quality of life, exercise capacity and pulmonary function in patients treated with coils are sustained twelve months after treatment.
Optimal medical therapy24
RENEW
Randomized controlled trial

Sciurba et al (8)
Coil treatment group and optimal medical therapy157At 12 months:
• The between-group SGRQ score improved −8.9 points (P < .001), favoring the coil group.
• Median change in 6MWD was 10.3m with coil treatment vs −7.6m with usual care, with a between-group difference of 14.6m (P = .02). Improvement of at least 25m occurred in 40.0% of patients in the coil group vs 26.9%with usual care (P = .01).
• The between-group difference in median change in FEV1was 7.0% (P < .001), favoring the coil group.
The use of endobronchial coils in patients with severe emphysema compared with usual care resulted in an improvement in median exercise tolerance at 12 months.
Optimal medical therapy158
REVOLENS
Randomized controlled trial

Deslee et al (9)
Coil treatment group and optimal medical therapy50At 6 and 12 months, respectively, improvements were observed in all outcome measures in the coil treatment group, with the following changes:
• SGRQ score: −11 and −9 points (P<0.00.01)
• 6MWD: +18 and -2 m (P=NS)
• FEV1: +9% and +8% (P=0.002)
• FVC: +15% and +14% (P=0.02)
• RV: −0.52 L and −0.47 L (P=0.004)
Bronchoscopic treatment with coils compared with usual care resulted in improved exercise capacity and quality of life.
Optimal medical therapy50
Prospective
clinical trial

Deslee et al (4)
Coil treatment60At 6 and 12 months, respectively, significant improvements (P<0.01) were observed in all outcome measures, with the following changes:
• SGRQ score: −12±13 and −11±13 points
• 6MWD: +30±74 m and +51±76 m
• FEV1: +0.11 ±0.20 L and +0.11±0.30 L
• RV: −0.65±0.90 L and −0.71±0.81 L
Coil treatment results in significant clinical improvements in patients with severe emphysema, with a good safety profile and sustained results for up to 1 year.
Prospective clinical trial

Slebos et al (2)
Coil treatment16Six months after treatment significant improvements (P<0.005) were observed in all outcome measures, with the following changes:
• SGRQ score: -15±12 points
• 6MWD: +84.4±73.4m
• FEV1: +14.9±17.0%
• FVC: +13.4±12.9%
• RV: -11.4±9.0%
Coil treatment results in significant improvements in pulmonary function, exercise capacity and quality of life with an acceptable safety profile.
Prospective registry

Fellrath et al (14)
Coil treatment29Six months after treatment significant improvements were observed in all outcome measures, with the following changes:
• SGRQ score: -14 ±12 points (P<0.0001), 87% responder rate
• 6MWD: +53.4 m ± 66.9 m (P<0.0021), 60% responder rate
• FEV1: +0.14 ± 0.22 L (P<0.0021), 57% achieved the MID of 10%
• RV: -0.91 ± 1 L (P<0.0002), 76% achieved the MID of −0.35 L
Endobronchial coil therapy yields high 6-month responder rates across all relevant outcomes.

6MWD = 6-minute walk distance
FEV1 = Forced expiratory volume in 1 sec
FVC = Forced vital capacity; MID=Minimally important difference
RV = Residual volume
SGRQ = St George’s Respiratory Questionnaire

(20)

Bronchoscopic Lung Volume Reduction Coil Treatment for Severe Emphysema: A Systematic Review and Meta-Analysis of Individual Participant Data

Sharyn A. Roodenburg, Jorine E. Hartman, Gaetan Deslee, Felix J.F. Herth, Karin Klooster, Frank C. Sciurba, Pallav L. Shah, Arschang Valipour, Zaid Zoumot, Dirk-Jan Slebos
Respiration April 2022; DOI: 10.1159/000524148

(19)

Endobronchial Coil System versus Standard-of-Care Medical Management in the Treatment of Subjects with Severe Emphysema

Karin Klooster, Arschang Valipour, Charles-Hugo Marquette, Jacques Boutros, Herve Mal, Armelle Marceau, Pallav L. Shah, Francesca Conway, Gaetan Deslee, Arnaud Bourdin, Christophe Pison, Christian Grah, Martin Hetzel, Christian Schumann, Romain Kessler, Ralf-Harto Huebner, Dirk Skowasch, Kaid Darwiche, Peter Hammerl, Franz Stanzel, Michaela Bezzi, Herve Dutau, Felix J.F. Herth, Dirk-Jan Slebos
Respiration May 2021; DOI: 10.1159/000515744

(18)

Predictors of Response to Endobronchial Coil Therapy in Patients With Advanced Emphysema

Dirk-Jan Slebos, MD, PhD, Joseph Cicenia, MD, Frank C. Sciurba, MD, Gerard J. Criner, MD, Jorine E. Hartman, PhD, Justin Garner, MBBS, Gaëtan Deslée, MD, Antoine Delage, MD, Michael Jantz, MD, Charles-Hugo Marquette, MD, PhD, Charlie Strange, MD, Umur Hatipoglu, MD, Atul C. Mehta, MD, Adam S. LaPrad, PhD, Gerald Schmid-Bindert, MD, Felix J.F. Herth, MD, PhD, Pallav L. Shah, MD
Chest 2019 155:928-937. doi: 10.1016/j.chest.2019.02.012.

(17)

Endobronchial Coils for Endoscopic Lung Volume Reduction: Best Practice Recommendations from an Expert Panel

Dirk-Jan Slebos, Nick H. ten Hacken, Martin Hetzel, Felix J.F. Herth, Pallav L. Shah
Respiration 2018;96:1-11; DOI: 10.1159/000490193

(16)

Endoscopic lung volume reduction coil treatment in patients with very low FEV 1: an observational study

Marcel Simon, Lars Harbaum, Tim Oqueka, Stefan Kluge, Hans Klose
Ther Adv Respir Dis 2018 ;12:1753466618760133. doi: 10.1177/1753466618760133.

(15)

Importance of bronchoscopic lung volume reduction coil therapy in potential candidates for lung transplantation

Askin Gulsen
Biosci Trends 2018 Sep 19;12(4):395-402. doi: 10.5582/bst.2018.01134.

(14)

Endobronchial coil therapy in severe emphysema: 6-month outcomes from a Swiss National Registry

Jean-Marc Fellrath, Thomas Scherer, Daniel P. Franzen, Alban Lovis, Christophe von Garnier, Jérôme Plojoux, Paola M. Soccal
J Thorac Dis 2018 10(Suppl 23):S2711-S2718. doi: 10.21037/jtd.2018.04.53.

(13)

Endoscopic lung volume reduction coil treatment in patients with chronic hypercapnic respiratory failure: an observational study

Marcel Simon, Lars Harbaum, Tim Oqueka, Stefan Kluge, Hans Klose
Ther Adv Respir Dis 2017 Jan;11(1):9-19. doi: 10.1177/1753465816676222.

(12)

Coil therapy for patients with severe emphysema and bilateral incomplete fissures – effectiveness and complications after 1-year follow-up: a single-center experience

Konstantina Kontogianni, Vasiliki Gerovasili, Daniela Gompelmann, Maren Schuhmann, Hans Hoffmann, Claus Peter Heussel, Felix Jf Herth, Ralf Eberhardt
Int J Chron Obstruct Pulmon Dis 2017 Jan 23;12:383-394. doi: 10.2147/COPD.S117655.

(11)

The Safety and Feasibility of Re-treating Patients with Severe Emphysema with Endobronchial Coils: A Pilot Study

Jorine E. Hartman, Karin Klooster, Nick H.T. ten Hacken, Dirk-Jan Slebos
COPD 2017 May 14:339-343. doi: 10.1080/15412555.2017.1318842.

(10)

Two-year follow-up after endobronchial coil treatment in emphysema: results from the REVOLENS study

Gaëtan Deslée, Sylvie Leroy, Jeanne Marie Perotin, Hervé Mal, Hervé Dutau, Arnaud Bourdin, Jean Michel Vergnon, Christophe Pison, Romain Kessler, Vincent Jounieaux, Mathieu Salaün, Armelle Marceau, Sandra Dury, Jonathan Benzaquen, Margaux Bonnaire, Sylvain Dukic, Coralie Barbe, Charles Hugo Marquette
Eur Respir J 2017 Dec 21;50(6):1701740. doi: 10.1183/13993003.01740-2017.

(9)

Lung Volume Reduction Coil Treatment vs Usual Care in Patients With Severe Emphysema: The REVOLENS Randomized Clinical Trial

Gaëtan Deslée, Hervé Mal, Hervé Dutau, Arnaud Bourdin, Jean Michel Vergnon, Christophe Pison, Romain Kessler, Vincent Jounieaux, Luc Thiberville, Sylvie Leroy, Armelle Marceau, Sophie Laroumagne, Jean Pierre Mallet, Sylvain Dukic, Coralie Barbe, Julie Bulsei, Damien Jolly, Isabelle Durand-Zaleski, Charles Hugo Marquette
JAMA 2016 Jan 12;315(2):175-84. doi: 10.1001/jama.2015.17821.

(8)

Effect of Endobronchial Coils vs Usual Care on Exercise Tolerance in Patients With Severe Emphysema: The RENEW Randomized Clinical Trial.

Frank C Sciurba, Gerard J Criner, Charlie Strange, Pallav L Shah, Gaetane Michaud, Timothy A Connolly, Gaëtan Deslée, William P Tillis, Antoine Delage, Charles-Hugo Marquette, Ganesh Krishna , Ravi Kalhan, J Scott Ferguson, Michael Jantz, Fabien Maldonado, Robert McKenna, Adnan Majid 17, Navdeep Rai, Steven Gay, Mark T Dransfield, Luis Angel, Roger Maxfield, Felix J F Herth, Momen M Wahidi, Atul Mehta, Dirk-Jan Slebos, RENEW Study Research Group
JAMA. 2016 May 24-31;315(20):2178-89. doi: 10.1001/jama.2016.6261.

(7)

Evaluation of bronchoscopic lung volume reduction coil treatment results in patients with severe emphysema

Askin Gulsen, Fidan Sever, Pelin Girgin, Necdet Batuhan Tamci, Hatice Yilmaz
Clin Respir J 2017 Sep;11(5):585-592. doi: 10.1111/crj.12387.

(6)

Endobronchial Coils for Severe Emphysema Are Effective Up to 12 Months following Treatment: Medium Term and Cross-Over Results from a Randomised Controlled Trial

Zaid Zoumot, Samuel V Kemp, Suveer Singh, Stephen R Bicknell, William H McNulty, Nicholas S Hopkinson, Ewen T Ross, Pallav L Shah
PLoS One 2015 10(4):e0122656 doi:10.1371/journal.pone.0122656.

(5)

Lung Volume Reduction Coil Treatment in Chronic Obstructive Pulmonary Disease Patients with Homogeneous Emphysema: A Prospective Feasibility Trial

Karin Klooster, Nick H T Ten Hacken, Ina Franz, Huib A M Kerstjens, Eva M van Rikxoort, Dirk-Jan Slebos
Respiration 2014 88:116–125. doi: 10.1159/000362522.

(4)

Lung volume reduction coil treatment for patients with severe emphysema: a European multicentre trial

Gaëtan Deslee , Karin Klooster, Martin Hetzel, Franz Stanzel, Romain Kessler, Charles-Hugo Marquette, Christian Witt, Stefan Blaas, Wolfgang Gesierich, Felix J F Herth, Juergen Hetzel, Eva M van Rikxoort, Dirk-Jan Slebos
Thorax 2014 Nov;69(11):980-6. doi: 10.1136/thoraxjnl-2014-205221.

(3)

Endobronchial coils for the treatment of severe emphysema with hyperinflation (RESET): a randomised controlled trial

Pallav L Shah, Zaid Zoumot, Suveer Singh, Stephen R Bicknell, Ewen T Ross, John Quiring, Nicholas S Hopkinson, Samuel V Kemp
Lancet Respir Med 2013 May;1(3):233-40. doi: 10.1016/S2213-2600(13)70047-X.

(2)

Bronchoscopic lung volume reduction coil treatment of patients with severe heterogeneous emphysema

Dirk-Jan Slebos, Karin Klooster, Armin Ernst, Felix J F Herth, Huib A M Kerstjens
Chest 2012 Sep;142(3):574-582. doi: 10.1378/chest.11-0730.

(1)

Bronchoscopic lung volume reduction with a dedicated coil: a clinical pilot study

Felix J F Herth, Ralf Eberhard, Daniela Gompelmann, Dirk-Jan Slebos, Armin Ernst
Ther Adv Respir Dis 2010 Aug;4(4):225-31. doi: 10.1177/1753465810368553.

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