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Endobronchial coils for severe emphysema are effective up to 12 months following treatment: medium term and cross-over results from a randomised controlled trial.

Zoumot Z, Kemp SV, Singh S, Bicknell SR, McNulty WH, Hopkinson NS, Ross ET, Shah PL - PLoS ONE (2015)

Bottom Line: We report the medium term effectiveness and safety of coils in a study of patients with emphysema.The safety profile was acceptable out to 360 days post-treatment.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.

View Article: PubMed Central - PubMed

Affiliation: The NIHR Respiratory Biomedical Research Unit at the Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London, United Kingdom; Chelsea & Westminster Hospital NHS Foundation Trust, London, United Kingdom; Respiratory and Critical Care Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates.

ABSTRACT

Background: There is a clinical need for therapeutic options to reduce hyperinflation associated with severe emphysema. Endobronchial Coils (coils) are nitinol devices implanted bronchoscopically under fluoroscopic guidance to re-tension the lung. We report the medium term effectiveness and safety of coils in a study of patients with emphysema.

Methods: Forty five subjects with severe airflow obstruction and hyperinflation received bilateral sequential treatment with coils (30 day interval between treatments) as part of a randomised controlled trial with a primary endpoint 90 days after the final treatment (Clinicaltrials.gov NCT01334307). Further assessments were made at 180 and 360 days and in this study the primary outcome was the effect of coil treatment on the St. George's Respiratory Questionnaire (SGRQ) 360 days following treatment.

Results: At 360 days following treatment, there was an improvement in the SGRQ score of -6.1±14.0 points (p = 0.01) compared to baseline. Improvements in secondary outcomes were seen with increases in forced expiratory volume in the first second of 8.9 ±22.2% (p = 0.002) and 6-minute walking distance of 34.1±52.4m (p = 0.003). The safety profile was acceptable out to 360 days post-treatment.

Conclusions: 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.

Trial registration information: Clinicaltrials.gov NCT01334307.

No MeSH data available.


Related in: MedlinePlus

Efficacy outcomes in the coil treated patients 90, 180 and 360 days post final treatment.
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pone.0122656.g002: Efficacy outcomes in the coil treated patients 90, 180 and 360 days post final treatment.

Mentions: Fig 2 illustrates the efficacy outcomes in the coil treated patients 90, 180 and 360 days post final treatment. The treatment group had a -6.1±14.0 (p = 0.01) point improvement in the SGRQ 360 days after final treatment compared to baseline, with clinically and statistically significant benefits at all time points (Table 3). Exercise capacity, an important patient centred outcome, also improved significantly at all time points compared to baseline (Table 3). Improvements in lung function were seen with a 90±120 ml increase in the FEV1 90 days following the final treatment as compared to baseline (p = <0.0001), representing a 13.8±18.1% increase (p<0.0001). Benefits were maintained with 10.0±21.0% (p = 0.005) and 8.9±22.1% (p = 0.024) increases 180 and 360 days after treatment, respectively, as compared to baseline. RV and RV/total lung capacity (TLC) ratio, but not TLC, were significantly reduced at all time points as compared to baseline (Table 3).


Endobronchial coils for severe emphysema are effective up to 12 months following treatment: medium term and cross-over results from a randomised controlled trial.

Zoumot Z, Kemp SV, Singh S, Bicknell SR, McNulty WH, Hopkinson NS, Ross ET, Shah PL - PLoS ONE (2015)

Efficacy outcomes in the coil treated patients 90, 180 and 360 days post final treatment.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4390222&req=5

pone.0122656.g002: Efficacy outcomes in the coil treated patients 90, 180 and 360 days post final treatment.
Mentions: Fig 2 illustrates the efficacy outcomes in the coil treated patients 90, 180 and 360 days post final treatment. The treatment group had a -6.1±14.0 (p = 0.01) point improvement in the SGRQ 360 days after final treatment compared to baseline, with clinically and statistically significant benefits at all time points (Table 3). Exercise capacity, an important patient centred outcome, also improved significantly at all time points compared to baseline (Table 3). Improvements in lung function were seen with a 90±120 ml increase in the FEV1 90 days following the final treatment as compared to baseline (p = <0.0001), representing a 13.8±18.1% increase (p<0.0001). Benefits were maintained with 10.0±21.0% (p = 0.005) and 8.9±22.1% (p = 0.024) increases 180 and 360 days after treatment, respectively, as compared to baseline. RV and RV/total lung capacity (TLC) ratio, but not TLC, were significantly reduced at all time points as compared to baseline (Table 3).

Bottom Line: We report the medium term effectiveness and safety of coils in a study of patients with emphysema.The safety profile was acceptable out to 360 days post-treatment.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.

View Article: PubMed Central - PubMed

Affiliation: The NIHR Respiratory Biomedical Research Unit at the Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London, United Kingdom; Chelsea & Westminster Hospital NHS Foundation Trust, London, United Kingdom; Respiratory and Critical Care Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates.

ABSTRACT

Background: There is a clinical need for therapeutic options to reduce hyperinflation associated with severe emphysema. Endobronchial Coils (coils) are nitinol devices implanted bronchoscopically under fluoroscopic guidance to re-tension the lung. We report the medium term effectiveness and safety of coils in a study of patients with emphysema.

Methods: Forty five subjects with severe airflow obstruction and hyperinflation received bilateral sequential treatment with coils (30 day interval between treatments) as part of a randomised controlled trial with a primary endpoint 90 days after the final treatment (Clinicaltrials.gov NCT01334307). Further assessments were made at 180 and 360 days and in this study the primary outcome was the effect of coil treatment on the St. George's Respiratory Questionnaire (SGRQ) 360 days following treatment.

Results: At 360 days following treatment, there was an improvement in the SGRQ score of -6.1±14.0 points (p = 0.01) compared to baseline. Improvements in secondary outcomes were seen with increases in forced expiratory volume in the first second of 8.9 ±22.2% (p = 0.002) and 6-minute walking distance of 34.1±52.4m (p = 0.003). The safety profile was acceptable out to 360 days post-treatment.

Conclusions: 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.

Trial registration information: Clinicaltrials.gov NCT01334307.

No MeSH data available.


Related in: MedlinePlus