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: NCT 02159521.

Editor's Choice – European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs

“…Both PTS related clinical outcome and disease specific QoL improved significantly, irrespective of additional iliac vein stenting. 386 Recommendation of these techniques for clinical practice requires stronger evidence. 5.3.3.2.…”

Recurrent deep vein thrombosis following brown recluse spider bite complicated by medication noncompliance and residual scar tissue: A rare case report

“…A duplex scan suggested chronic DVT, for which venoplasty was done. 19 Despite this, the patient's condition did not improve much. Hence, the patient was sent to a venous thromboembolism clinic, which showed residual scar tissue.…”

“…On follow‐up, the patient had a recurrence of DVT. A duplex scan suggested chronic DVT, for which venoplasty was done 19 . Despite this, the patient's condition did not improve much.…”

Ultrasound-Accelerated Catheter-Directed Thrombolysis

“…The ACCESS PTS [ 6 ] is an open-label, single-arm, prospective study that involved multiple centers. The aim of this prospective study was to evaluate the efficacy of combined percutaneous transluminal venoplasty (PTV) and ultrasound-accelerated thrombolysis (USAT) in the management of symptoms and QOL in PTS patients with chronic veno-occlusive disease.…”