Single-Session Treatment of Patients with Symptomatic Iliocaval and Iliofemoral Deep Vein Thrombosis: Technical Results of a Prospective Pilot Study

Abstract

Purpose: To investigate the short-term results of single-session treatment of iliocaval and iliofemoral DVT using a single thrombectomy device.

Materials and methods: This prospective pilot study analyzed patients with acute iliocaval or iliofemoral DVT treated in a single session using the JETi thrombectomy system. All analyses were performed on an intention-to-treat basis. The cohort consisted of 53 limbs in 47 patients (27 women), with a mean age of 57 years (range, 16-88 years). The primary safety and efficacy endpoints were freedom from major adverse events (MAEs) and reestablishment of unobstructed flow in a single session, respectively.

Results: The mean duration of symptoms was 8.5 days ± SD 9.2, with 10 patients (11 limbs, 21.3%) presenting with a symptom duration of >14 days. Twelve (25.5%) patients had thrombosis of the inferior vena cava and the iliofemoral segments. During the index procedure, unobstructed flow was reestablished in 47 of 53 (88.6%) limbs in 41 of 47 (87.2%) patients (primary endpoint) with no MAEs through 30 days. Overall, unobstructed flow was restored in 50 of 53 (94.3%) limbs and in 44 of 47 (93.6%) patients.

Conclusions: Successful single-session treatment of patients with acute iliocaval and iliofemoral DVT is feasible with a high rate of efficacy and a low rate of adverse events. Such patients may be treated on an outpatient basis.