A75-08 Six-month Change in Post-bronchodilator Fev₁ After Bronchoscopic Lung Volume Reduction With the Spiration™ Valve System: Results From the STRIVE Post-market Registry

Background

Real-world outcomes after bronchoscopic lung volume reduction (BLVR) require contextualization given that treatment response depends on emphysema-severity and anatomic distribution. STRIVE is an FDA-mandated post-market registry of the Spiration™ Valve System (SVS). We examined six-month changes in post-bronchodilator FEV₁ and interpreted physiologic outcomes within a CT-characterized emphysema cohort.

Methods

We performed a complete-case analysis of STRIVE participants with paired baseline and six-month post-bronchodilator spirometry. The primary outcome was change in post-bronchodilator FEV₁ (FEV₁Post) from baseline to six-months. CT-derived emphysema metrics were obtained from SeleCT reports and included lobar-emphysema percentage at − 950-Hounsfield-units, fissure completeness/integrity, and lobar volumes. Emphysema-heterogeneity was defined as the absolute-difference in emphysema-burden between the treated-lobe (right upper+middle vs right lower; left upper vs left lower) and the ipsilateral untreated-counterpart. Treatment-target-alignment was described by whether the treated lobe had the highest emphysema percentage among candidate lobes. Six-month changes in FEV₁Post were assessed using paired statistical-tests. Subgroup comparisons by CT-defined characteristics were exploratory.

Results

Among 62 subjects, baseline-characteristics reflected advanced emphysema: FEV₁Post 0.85 ± 0.33 L (median 0.76), RV 4.69 ± 1.24 L, TLC 7.18 ± 1.57 L, RV/TLC 0.65 ± 0.08, and mMRC median 2. CT-phenotyping showed average whole-lung emphysema (−950 HU) of 31.1 ± 11.5% and treated-lobe emphysema of 40.3 ± 14.7%. Average fissure completeness/integrity median was 94.4% and average heterogeneity was 13.2%. Treated lobes were left upper (46.8%), left lower (22.6%), right upper (14.5%), right lower (9.7%), and right upper+middle (6.5%). The treated lobe was the most-diseased in 35/62 (56.5%). At 6 months, FEV₁Post increased by + 131.9 mL (mean; 95% CI: 77.3, 186.5 mL; p < 0.001). Clinically anchored responder definition of ≥ 100 mL improvement was met by 48.4%. Exploratory revealed that the change in post-bronchodilator FEV₁ was larger when the most diseased lobe was treated (+0.149 L vs + 0.097 L) although no statistically-significant in this interim sample. Six-minute-walk-distance (available N = 59) showed no significant mean change; dyspnea improved in parallel (mMRC mean change −0.83; 95% CI: -1.23, -0.41).

Conclusions

In this complete-case interim-analysis of the STRIVE registry, BLVR with the Spiration™ Valve System was associated with statistically-significant and clinically meaningful improvements in post-bronchodilator FEV₁ at 6months among patients with CT-confirmed severe-emphysema. CT-based-phenotyping demonstrated possibly greater physiologic gains when treatment targeted the most diseased, albeit not statistically-significant in this interim analysis, highlighting the potential importance of treatment-target-alignment in interpreting real-world registry outcomes and informing patient selection for BLVR. Research funded by Olympus.

Acknowledgments: Priya Walia and Helga Criner

This abstract is funded by: Olympus