VIVA Holds Vascular Leaders Forum on Deep Venous Disease and Practices

May 10, 2022—The VIVA Foundation recently convened a Vascular Leaders Forum (VLF) to explore and better understand current data and outcomes in deep venous therapy, with an eye toward developing guidance on optimal study design and assessment of venous thrombectomy and stent devices. The VLF comprised a full day of presentations and panel discussions from leading clinical experts and trialists, industry representatives, and regulators from the FDA.

A session on iliac vein stenting focused on available trial data and the knowns and unknowns of appropriate patient selection, current stent design platforms and outcomes, and optimal medical therapy after placement. Experts, industry, and FDA discussed recent device recalls and issues related to migration and maldeployment and the global need to better understand appropriate patient selection to ensure optimal outcomes. Intraprocedural imaging to ensure patient candidacy and accurate deployment if placing a stent is essential in this regard, but the variance in imaging modality use and vein sizing methods poses challenges in data interpretation and generalizability.

Continuing to collect the necessary data to inform these decisions and educating an expanding group of treating physicians were identified as essential next steps in ensuring safe and durable outcomes in the postapproval setting. The need for multidisciplinary planning and follow-up was also discussed, with an emphasis on having a long-term plan at the time of implantation.

Next, the focus shifted to the use of thrombectomy in deep vein thrombosis, starting with a review of the strengths and limitations of available trial data, followed by a look at the rapidly expanding class of device options in this space. As was the case in the sessions on venous stenting, the panels avoided focusing on advantages and disadvantages of individual platforms, citing the lack of comparative and granular data and instead focusing primarily on key questions such as patient selection and appropriate outcome measures for future trials.

The day’s proceedings will serve as a launch point for the development of peer-reviewed publications in the ensuing months, with a focus on reporting standards in venous intervention research.

“At the VIVA Foundation, we aspire to provide platforms for multidisciplinary collaboration,” said Saher Sabri, MD, Chair of the Venous VLF and a VIVA Foundation board member. “It was a pleasure to hold this venous-focused VLF and bring together key venous disease experts, industry, and regulatory participants to address opportunities to advance the field.”