Ultrasound-Accelerated Thrombolysis and Venoplasty for the Treatment of the Postthrombotic Syndrome: Results of the ACCESS PTS Study

Abstract

Background Postthrombotic syndrome is a common complication of deep vein thrombosis, with limited treatment options. Methods and Results ACCESS PTS (Accelerated Thrombolysis for Post-Thrombotic Syndrome Using the Acoustic Pulse Thrombolysis Ekosonic Endovascular System) is a multicenter, single-arm, prospective study evaluating patients with chronic deep vein thrombosis and postthrombotic syndrome (Villalta score ≥8) who received minimum 3 months of anticoagulation. Patients underwent percutaneous transluminal venoplasty and ultrasound-accelerated thrombolysis, with data collected on clinical characteristics, postthrombotic syndrome, imaging, and quality of life to 1 year. The primary efficacy outcome was a reduction of ≥4 points in the Villalta score 30 days after procedure. The primary safety outcomes were major bleeding episodes within 72 hours and symptomatic pulmonary embolism during the index hospitalization. A total of 82 limbs (78 patients) were treated (age, 54.6±12.7 years; 32.1% women; mean Villalta score, 15.5±5.2). The primary end point was met in 64.6% (51/79). At 1 year, 77.3% (51/66) of limbs continued with a Villalta reduction ≥4. At 365 days, >90% of segments had patency with ultrasound flow present. Baseline to 1-year Physical Component Summary mean score of the Short Form-36 increased from 38.9±9.5 to 45.2±9.8 (P≤0.0001), and mean VEINES-QOL (Venous Insufficiency Epidemiological and Economic Study-Quality of Life) increased from 61.9±19.7 to 82.6±20.8 at 1 year (P<0.0001). Iliofemoral venous stenting was performed in 42 patients, with similar improvements seen in all outcomes, regardless of stenting status. One patient developed severe bleeding within 72 hours of the intervention and died at 32 days after procedure (1.3% mortality rate). Conclusions Percutaneous transluminal venoplasty and ultrasound-accelerated thrombolysis resulted in successful recanalization of chronic venous obstruction with improved postthrombotic syndrome severity and quality of life. Results were sustained at 1-year after procedure. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02159521.

Keywords: deep vein thrombosis; pharmacomechanical thrombectomy; postthrombotic syndrome; ultrasound‐accelerated thrombolysis.

Figures

Figure 1

ACCESS PTS (Accelerated Thrombolysis for Post‐Thrombotic Syndrome Using the Acoustic Pulse Thrombolysis Ekosonic Endovascular System) patient enrollment.

Figure 2

Results of the Villalta scale, Venous Clinical Severity Score (VCSS), Short Form‐36 (SF‐36) Physical Component Score (PCS), and VEINES‐QOL (Venous Insufficiency Epidemiological and Economic Study–Quality of Life) change from baseline through 365 days of follow‐up. A, Villalta score result change from baseline with SE. B, VCSS result change from baseline with SE. C, SF‐36 PCS result change from baseline with SE. D, VEINES‐QOL result change from baseline with SE.

Figure 3

Venographic and Doppler flow over time per venous segment. Data represent comparison of any flow identified in venous segments that were treated during the procedure, from baseline venographic imaging through follow‐up duplex ultrasound imaging. CFV indicates common FV; CIV, common iliac vein; EIV, external iliac vein; FV, femoral vein.

Figure 4

Stent vs nonstented subgroup results from baseline through 365 days of follow‐up of the Villalta scale, Venous Clinical Severity Score (VCSS), Short Form‐36 (SF‐36) Physical Component Score (PCS), and VEINES‐QOL (Venous Insufficiency Epidemiological and Economic Study–Quality of Life). A, Villalta score result stent vs nonstented subgroup change from baseline with SE. B, VCSS result stent vs nonstented subgroup change from baseline with SE. C, SF‐36 PCS result stent vs nonstented subgroup change from baseline with SE. D, VEINES‐QOL result stent vs nonstented subgroup change from baseline with SE.