Zephyr Valve benefits previously ineligible patients after blocking of collateral channels with AeriSeal: CONVERT Trial

<bold>Background:</bold> CONVERT is a multicenter, single-arm study in emphysema patients to evaluate use of AeriSeal (AS) to block collateral channels to change CV+ to CV- status to allow BLVR with Zephyr valves (ZV). <bold>Objectives:</bold> 1) Evaluate ability of AS to block collateral channels to convert lobes from CV+ to CV-. 2) Assess clinical outcomes after ZV treatment in the CV- converted patients. <bold>Methods:</bold> Treat Chartis confirmed CV+ lobe(s) in eligible patients with upto 40mL AS in maximum 2 sessions. Assess CV status at Day 45 post-last AS treatment and treat with ZV if CV-. Assess clinical outcomes at 6-months post-ZV. <bold>Results:</bold> 101 subjects (57M/44F) enrolled and treated with AS. Mean±SD age 65.1±6.9 yrs; post-BD FEV1 30.7±9.2% pred.; RV 236±47% pred.; mean fissure completeness range 68% to 88%. Lobes treated were: 16 RUL, 22 RUL+RML, 12 RLL, 28 LUL, and 23 LLL. Of the 97 subjects completing the first stage, 77.3% successfully converted and were treated with ZV. Mean TLVR at Day 45 for these 75 subjects was 56.6% with 89% achieving MCID of -350mL. After ZV treatment, outcome changes from Baseline to 6 months were:TLVR -1016±623mL, FEV1 +11.4±25.0%, RV -660±960mL, and SGRQ -6.6±19.6 pts. SAEs to date include inflammatory response (post-AS) 15.7%; COPD exacerbation 10.8%; pneumonia 9.8%; pneumonitis 5.9%; fever 3.9%; chest pain 2.9%; respiratory failure 2.0%; pneumothorax (only after ZV) 23.7%; and death 1.0% (9 months after ZV). All AEs were managed with standard medical care. <bold>Conclusions:</bold> AeriSeal is safe and effective in occluding collateral channels to convert a CV+ lobe to CV-, allowing emphysema patients with collateral ventilation to undergo and benefit from BLVR with ZV.