Abstract
BackgroundAn innovative approach to lung volume reduction (LVR) for emphysema is introduced in the design of the Sequential Segmental Treatment of Emphysema with Upper Lobe Predominance (STEP-UP) trial where vapour ablation is administered bilaterally over the course of two sessions and is used to target only the most diseased upper lobe segments. By dividing the procedure into two sessions, there is potential to increase the total volume treated per patient but reduce volume treated and energy delivered per session. This is expected to correlate with improvements in vapour ablation’s safety and efficacy profiles.MethodsThe STEP-UP trial is a randomized, controlled, open-label, 12 month study of patients with upper lobe predominant emphysema (ULPE). The trial compares patients receiving standard medical management alone against patients receiving bilateral vapour ablation in addition to standard medical management. An intended sixty nine subjects will be randomized at a 2:1 (treatment arm:control arm) ratio. Inclusion criteria include a forced expiratory volume in 1 second (FEV1) between 20% and 45% predicted, total lung capacity > 100% predicted, residual volume > 150% predicted, marked dyspnea scoring ≥ 2 on the modified Medical Research Council (mMRC) scale, and PaCO2 ≤ 50 mm Hg. The primary endpoints are the change in FEV1 %predicted and St. George Respiratory Questionnaire (SGRQ) score between the treatment and control arm at 12 months. Adverse events will be monitored as secondary endpoints along with other efficacy outcomes at 6 and 12 months.DiscussionVapour ablation can reduce lung volume in the presence of collateral ventilation (CV). Due to this ability, it can be used to target specifically the more diseased segments of each upper lobe. Safety and efficacy outcomes are expected to improve by considering which segments to treat along with the volume treated per session and per patient.Trial registrationClinicalTrials.gov NCT01719263.
Highlights
An innovative approach to lung volume reduction (LVR) for emphysema is introduced in the design of the Sequential Segmental Treatment of Emphysema with Upper Lobe Predominance (STEP-UP) trial where vapour ablation is administered bilaterally over the course of two sessions and is used to target only the most diseased upper lobe segments
The purpose of this paper is to describe the design and rationale of the Sequential Segmental Treatment of Emphysema with Upper Lobe Predominance (STEP-UP) trial
If we look to the future potential of bronchoscopic LVR in general and vapour therapy in particular we note that 1) due to the progressive nature of emphysema, the segments are expected to worsen overtime causing pulmonary function to decline, 2) because not all segments are treated during the STEP-UP trial, the segmental approach may potentially be utilized in the future as a follow-up treatment for patients who have previously been treated for emphysema and 3) a focused segmental approach across all affected lobes might elucidate therapeutic targets in whole patient populations previously generalized as having a diffuse disease
Summary
An innovative approach to lung volume reduction (LVR) for emphysema is introduced in the design of the Sequential Segmental Treatment of Emphysema with Upper Lobe Predominance (STEP-UP) trial where vapour ablation is administered bilaterally over the course of two sessions and is used to target only the most diseased upper lobe segments. By dividing the procedure into two sessions, there is potential to increase the total volume treated per patient but reduce volume treated and energy delivered per session. This is expected to correlate with improvements in vapour ablation’s safety and efficacy profiles. Complications included prolonged hospital stays (25% >30 days), air leak (~90%), and respiratory or cardiac complications [2,3,4] These complications have limited the adoption of LVRS as a routine therapy for patients with severe emphysema and have presented a medical need for an alternate effective method to achieve lung volume reduction (LVR) with an improved safety profile. One bronchoscopic technique is vapour ablation (InterVapor, Uptake Medical, California, USA)
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