Icon Legend

This session is not in your schedule.

This session is in your schedule. Click again to remove it.

Poster Icons

Marie Brown Etris Oral Abstract Award

Highest Scoring Poster Abstract

Rapid-Fire Poster Talks

Late Breaking Abstract

People's Choice Award Nominee

People's Choice Award Winner

Wound Healing Society

Virtual Poster Hall Sponsor

Back

Rate ePoster137 Views

Clinical Research

(CR-037) A Novel Mechanical Thrombectomy Device for Iliofemoral In-Stent Thrombosis: Retrospective Analysis of Outcomes for Patients with Venous Leg Ulcers

Thursday, May 16, 2024

7:30 PM – 8:30 PM East Coast USA Time

Abdullah Shaikh, MD; Min Choi, MD; Steven Abramowitz, MD

Introduction: Lower extremity in-stent thrombosis (IST) is common in patients with postthrombotic syndrome (PTS),¹ a chronic disease that can involve formation of venous leg ulcers (VLUs) in severe cases.² Current endovenous therapies for IST with ulcerative PTS are generally insufficient,³ but a new mechanical thrombectomy (MT) device* specifically designed to treat deep-vein IST has recently become available.⁴ Here, results of a MT procedure are presented for patients with iliofemoral IST and secondary venous wounds.

Methods: This retrospective analysis included all adult patients from 3 centers who 1) presented with iliofemoral IST and ≥1 VLU and 2) were treated with MT using the study device from March–November 2023. The primary endpoint is postprocedural stent patency with effective diameter ≥50%. The secondary endpoint is 30-day device-related major adverse events (MAEs), encompassing mortality, readmission, clinically significant pulmonary embolism, and vessel perforation. Ulcer data and additional outcomes were also collected.

Results:

The analysis included 12 VLUs and 10 treated stents in 5 patients with iliofemoral IST. Mean age of the all-male population was 55.2±18.9 years, and median IST symptom duration was 2.0 [IQR 0.8–5.0] years. At baseline, inner lumen area was 0.9±1.3 cm² and effective stent diameter was 16.0±22.7 cm. At procedure completion, 90.0% [86.3%–90.0%] of thrombus was extracted, inner lumen area increased to 14.1±6.5 cm², and effective stent diameter increased by 88.2±6.3 cm. All (100%) stents met the primary endpoint. No postthrombectomy stent fractures were observed. One (10.0%) stent was relined because of residual stenosis after MT, and the estimated blood loss was 75.0 [45.0–75.0] mL. The 30-day MAE rate was 0%. At 3-month follow-up, 1 stent demonstrated restenosis unrelated to the procedure and underwent successful reintervention with the study device. For VLUs with available data (N=7), area decreased from 9.9±9.3 cm² at baseline to 3.1±6.5 cm² (-68.7%) at ~3-month follow-up, with 3 (42.9%) wounds completely resolved and 4 (57.1%) noticeably healing.

Discussion: These results indicate that a MT device designed to treat IST is safe and effective in patients with chronic PTS. Additional studies are needed to confirm these outcomes.