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Signs and Symptoms of Chest Diseases |

Randomized Controlled Trial of RePneu Endobronchial Coils for the Treatment of Severe Emphysema With Hyperinflation (RESET) FREE TO VIEW

Zaid Zoumot*, MBBS; Samuel Kemp, MBBS; Cielito Caneja, RN; Rekha Chaudhuri, MD; Stephen Bicknell, MD; Nicholas Hopkinson, PhD; Suveer Singh, PhD; Ewen Ross, MD; Pallav Shah, MD
Author and Funding Information

National Institute for Health Research Respiratory Biomedical Research Unit at the Royal Brompton and Harefield Hospital Trust and Imperial College, London, United Kingdom


Chest. 2012;142(4_MeetingAbstracts):1024A. doi:10.1378/chest.1457157
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Abstract

SESSION TYPE: Late-Breaking Abstracts

PRESENTED ON: Tuesday, October 23, 2012 at 04:30 PM - 05:45 PM

PURPOSE: Therapeutic options for severe emphysema with gas trapping and hyperinflation are limited. The predominant pathophysiology of dynamic airway collapse with minimal expiratory effort renders drug therapy of little benefit. Lung volume reduction surgery (LVRS) and endobronchial valve treatment have some success but only in selected patients with low exercise capacity and upper lobe-predominant emphysema (LVRS), or heterogenous disease in the absence of collateral ventilation (valves). RePneu Lung Volume Reduction Coils (LVRCs) are self-actuating implantable devices composed of nitinol. They are implanted bronchoscopically using conscious sedation. The LVRC is delivered into targeted airways using fluoroscopic guidance, and when its sheath is removed recoils to it original pre-determined shape.

METHODS: In a randomised study of LVRCs on patients with severe emphysema and hyperinflation, 63 patients were screened at 3 centres in the United Kingdom with 23 randomised to treatment with LVRCs and 24 to best medical care (control). LVRC patients were initially treated in one lung, with the contralateral lung treated after one month if appropriate. The primary end point was the difference between treatment and control groups in the St. George’s Respiratory Questionnaire (SGRQ) 90 days post-final treatment. The trial is registered with ClinicalTrials.gov (NCT01334307).

RESULTS: Significant improvements in the treatment group compared to control group were observed for the primary end point mean SGRQ (Δ-10.54 points, p=0.004), as well as secondary end points mean six-minute walk distance (Δ+70.39 meters, p<0.001) and forced expiratory volume in one second (Δ+12.81%, p=0.009). Between group difference in change in mean residual volume did not reach significance (Δ-0.35 litres, p=0.051), despite a 0.64 litre reduction in the treatment group. There was a good safety profile with treatment.

CONCLUSIONS: Treatment with endobronchial coils in patients with severe emphysema and hyperinflation significantly improves quality of life, exercise capacity and pulmonary function with a good safety profile.

CLINICAL IMPLICATIONS: LVRCs present a novel, safe, and minimally invasive treatment option for patients with both homogenous and heterogenous emphysema, with benefits unaffected by collateral ventilation. A larger randomised controlled pivotal trial with longer follow-up is now needed. Funding shared by PneumRx and study sites.

DISCLOSURE: Zaid Zoumot: Grant monies (from industry related sources): Reimbursment from PneumRx to host institutions for grant expenses, Other: Support from PneumRx for travel expenses to attend and present at ATS conference May 2012

Samuel Kemp: Grant monies (from industry related sources): Samuel.Kemp@sfh-tr.nhs.uk, Other: Support from PneumRx for travel expenses to attend and present at ATS conference May 2012

Cielito Caneja: Grant monies (from industry related sources): Reimbursment from PneumRx to host institutions for grant expenses

Rekha Chaudhuri: Grant monies (from industry related sources): Reimbursement from PneumRx to host institutions for trial expenses

Stephen Bicknell: Grant monies (from industry related sources): RReimbursement from PneumRx to host institutions for trial expenses.

Nicholas Hopkinson: Grant monies (from industry related sources): Reimbursement from PneumRx to host institutions for trial expenses

Suveer Singh: Grant monies (from industry related sources): Reimbursment from PneumRx to host institutions for grant expenses

Ewen Ross: Grant monies (from industry related sources): Reimbursement from PneumRx to host institutions for trial expenses.

Pallav Shah: Grant monies (from industry related sources): Reimbursment from PneumRx to host institutions for grant expenses

The RePneu lung volume reduction coils are CE marked in Europe. They are not approved for clinical use in the USA outside of clinical trials and are considered research at this time.

National Institute for Health Research Respiratory Biomedical Research Unit at the Royal Brompton and Harefield Hospital Trust and Imperial College, London, United Kingdom

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