Associate Professor University Hospitals Cleveland Medical Center Beachwood, Ohio, United States
Objective: Venous stenting was first reported in the 1990’s. The first US FDA-approved venous stent was in 2019. Appropriateness for Use Criteria for deep venous stenting remains limited. We report trends in venous stenting between 2014 and 2021.
Methods: We queried TriNetX, a global electronic health research network, for stents placed between 1/1/2014 - 12/31/2021 based on CPT codes (37238, 37239). Complete records of adults were downloaded, including demographics (age at time of stenting, gender, race). Associated lower extremity venous disease ICD9/10 codes used within 1-year of stenting were identified and categorized by groups (G): G1) Acute deep venous thrombosis (DVT) G2) Chronic DVT G3) Pelvic Congestion Syndrome G4) Nonthrombotic Iliac Vein Lesion (NIVL) G5) Chronic venous insufficiency (CVI) no inflammation G6) CVI with inflammation G7) CVI with ulceration. Exclusion criteria: < 18 y/o, venous stenting for dialysis, missing ICD9/10 code. Data were analyzed for trends in venous stent usage over time and across 3 time (T) periods: T1) before US FDA approval T2) from FDA approval to 1st FDA recall T3) After FDA recall. Data were analyzed in R: 1) multinomial modeling to estimate risk factors and differences in indications for stenting over time 2) univariate chi-squared tests to assess rates of stenting over time. Survival analyses was performed for each time period to identify mortality risk factors.
Results: Table 1 reports venous stent usage rates (overall and across T1-T3) by demographics, indications for stenting and overall mortality. Significant differences were identified in gender, race and overall mortality (p < 0.05). Top 4 indications for venous stenting were G1 >G2 >G4 >G5. There was a significant increase in venous stent usage (stents/day) over time despite recall (T1: 2.16; T2: 2.72, T3: 2.35; p < 0.00001). On multivariate regression analysis, from T1 to T2, increased stenting occurred in: more white and female patients (p < 0.005); G1 and G2 (p < 0.01) and decreased for G4,5,6 (p < 0.002). From T2 to T3 no changes occurred across indications for stenting (p >0.05). Risk factors in T1 and T2 for overall mortality at >2 years post-stenting included Age, Men, G2,4,7. African American race was a risk factor in T1.
Conclusions: Significant increases in venous stenting occurred after US FDA approval and remained unchanged after FDA recall. Indications are broad and may not all be appropriate use of venous stenting. Further work is needed to understand the venous stent landscape usage and minimize unnecessary stenting.