Fixed low-dose ultrasound-assisted catheter-directed thrombolysis followed by routine stenting of residual stenosis for acute ilio-femoral deep-vein thrombosis

Abstract

Patients with ilio-femoral deep-vein thrombosis (DVT) are at high risk of developing the post-thrombotic syndrome (PTS). In comparison to anticoagulation therapy alone, extended venography-guided catheter-directed thrombolysis without routine stenting of venous stenosis in patients with ilio-femoral DVT is associated with an increased risk of bleeding and a moderate reduction of PTS. We performed a prospective single-centre study to investigate safety, patency and incidence of PTS in patients with acute ilio-femoral DVT treated with fixed-dose ultrasound-assisted catheter-directed thrombolysis (USAT; 20 mg rt-PA during 15 hours) followed by routing stenting of venous stenosis, defined as residual luminal narrowing >50%, absent antegrade flow, or presence of collateral flow at the site of suspected stenosis. A total of 87 patients (age 46 ± 21 years, 60% women) were included. At 15 hours, thrombolysis success ≥50% was achieved in 67 (77%) patients. Venous stenting (mean 1.9 ± 1.3 stents) was performed in 70 (80%) patients, with the common iliac vein as the most frequent stenting site (83%). One major (1%; 95% CI, 0-6%) and 6 minor bleedings (7%; 95%CI, 3-14%) occurred. Primary and secondary patency rates at 1 year were 87% (95% CI, 74-94%) and 96% (95% CI, 88-99%), respectively. At three months, 88% (95% CI, 78-94%) of patients were free from PTS according to the Villalta scale, with a similar rate at one year (94%, 95% CI, 81-99%). In conclusion, a fixed-dose USAT regimen followed by routine stenting of underlying venous stenosis in patients with ilio-femoral DVT was associated with a low bleeding rate, high patency rates, and a low incidence of PTS.

Ultrasound-Assisted Versus Conventional Catheter-Directed Thrombolysis for Acute Iliofemoral Deep Vein Thrombosis

“…The catheter system consists of 3 components: the EkoSonic control unit; an intelligent drug delivery catheter (IDDC); and a removable MicroSonic Device (MSD) containing multiple small, radiopaque ultrasound transducers distributed along the treatment zone (12-50 cm). 20 The MSD is placed within the central lumen of the IDDC to deliver high-frequency (2.2 MHz) and low-power (0.5 Watt per transducer) ultrasound. The EkoSonic control unit provides power to the system and continuously adjusts the administered ultrasound energy according to the temperature at the treatment zone measured by the thermocouples within the IDDC.…”

“…As previously described, a standardized thrombolysis protocol with 20 mg r-tPA over 15 hours (without bolus) was used in both groups, with a continuous infusion of r-tPA (Actilyse, Boehringer Ingelheim, Germany) at a rate of 2 mg/h for the first 5 hours, then reduced to 1 mg/h for the remaining 10 hours, with normal saline coolant at a rate of 35 mL/h. 20 In case of bilateral catheter insertion, 10 mg of r-tPA over 15 hours were administered per catheter. Intermittent pneumatic compression devices were applied on both legs during catheter thrombolysis.…”

“…Adjunctive angioplasty and stenting using self-expandable venous stents (for inferior vena cava, sinus-XL from OptiMed [Ettlingen, Germany]; for iliac veins, Zilver Vena from Cook [Bloomington, Ind] and sinus-Venous from OptiMed; for femoral veins, sinus-SuperFlex from OptiMed) was performed in the presence of residual venous stenosis defined as luminal narrowing >50% by quantitative angiography or intravascular ultrasound, or absent antegrade flow, or presence of collateral flow at the site of suspected stenosis. 20 Intravascular ultrasound was occasionally used to identify residual venous stenosis in case of equivocal venographic results.…”

Early clinical outcomes of a novel rheolytic directional thrombectomy technique for patients with iliofemoral deep vein thrombosis

“…Diagnosis of an iliac vein compression syndrome or of residual post-thrombotic obstruction was established after successful thrombus removal by digital subtraction venography in two orthogonal views or by intravascular ultrasound if venography was equivocal. Stenting was performed in the presence of a venous stenosis > 50 % by intravascular ultrasound or venography or in the presence of collateral fl ow, or in the absence of fl ow [14].…”

State of the art of catheter-directed thrombolysis for iliofemoral venous thrombosis

“…Of course, a patient should be able to cooperate with medical professionals during the treatment and should be able to stay in bed for some days. There are no standard contraindications for teenage patients or for patients of old age [11,12].…”