An analysis of venous stent usage trends in the United States from 2014 through 2021 showed a “significant increase” in stents per day placed over time, despite high-profile recalls of two dedicated venous stents from the market.
Those were among the observations of Karem Harth, MD, associate professor of surgery and director of the Center for Comprehensive Venous Care at University Hospitals in Cleveland, Ohio, who led the investigation, which looked at the total eight-year period of the study and three distinct timeframes within it: before Food and Drug Administration (FDA) approval of dedicated venous stents; from FDA approval through to the date of the first recall; and the period after the recall. Harth delivered the results at 2023 annual meeting of the American Venous Forum (AVF) held in San Antonio, Texas (Feb. 22–25).
In an interview with Vascular Specialist during the AVF meeting, she said the increase in usage was not surprising but did highlight a number of areas in need of evaluation.
“In our data, we looked at a large consortium of hospitals through the TriNetX database, and we looked at clinical indications for venous stenting throughout time, and how venous stent use increased and changed over the FDA period of approval,” she explained. “We found that there was a significant increase in stenting since FDA approval, which is not surprising because this therapy is exciting and long awaited.
“But what we also found was that the top three diagnoses included acute deep vein thrombosis [DVT], NIVLs or non-thrombotic iliac vein lesions, as well as mild chronic venous insufficiency [CVI], which came as a surprise to us when we looked at this data, and that trend remained over time.”
After analyzing venous stent usage rates both overall and across the three time periods by demographics, indications for stenting, and overall mortality, significant differences were identified in terms of gender, race and overall mortality (p < 0.05), Harth said.
In addition to the increase in stent usage overall (p<0.00001), on multivariate regression analysis Harth and colleagues recorded an increase from the period prior to FDA venous stent approval to the period afterward until the first stent recall among more white and female patients (p<0.005), as well as in both acute and chronic DVT patients (p<0.01).
Meanwhile, in the same timeframe the trend showed decreased usage in patients with NIVLs, CVI with no inflammation, and CVI with inflammation. From the second time period (FDA approval–first recall) to the third (after the recall), no changes occurred across indications for stenting (p >0.05), Harth told AVF 2023. Risk factors in the first and second periods for overall mortality at more than two years post-stenting included age, male sex and chronic DVT, NIVL, and CVI with ulceration, while African-American race was a risk factor in the period prior to venous stent approval, she added.
Harth concluded her podium presentation by stating that “significant increases in venous stenting occurred after U.S. FDA approval and remained unchanged after FDA recall.” Indications are broad and “may not all be appropriate use of venous stenting,” she said, highlighting the need for further work to understand the venous stent landscape, usage and to minimize unnecessary stenting. Further, Harth stated that “there is a need to understand barriers to access to these therapies among underrepresented groups.”
Afterward, she told Vascular Specialist: “I think this data points to a need to evaluate how these stents are being used, the appropriateness for use, the clinical indication and how it may or may not align with our current criteria. It also showed that there were some disparities in terms of who has access to these stents, with mostly white women undergoing stenting.”