EndoVascular Consultants Wilmington DE.
Department of Cardiovascular and Interventional Radiology Inova Alexandria Hospital Alexandria VA.
J Am Heart Assoc. 2020 Feb 4;9(3):e013398. doi: 10.1161/JAHA.119.013398. Epub 2020 Jan 25.
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 (≤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 (<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.
血栓后综合征是深静脉血栓的常见并发症，治疗选择有限。
ACCESS PTS（使用声脉冲溶栓的血栓后综合征加速溶栓术）是一项多中心、单臂、前瞻性研究，评估了接受至少 3 个月抗凝治疗的慢性深静脉血栓形成和血栓后综合征（Villalta 评分≥8）患者。患者接受经皮腔内血管成形术和超声加速溶栓治疗，在 1 年时收集临床特征、血栓后综合征、影像学和生活质量数据。主要疗效终点是术后 30 天 Villalta 评分降低≥4 分。主要安全性终点是 72 小时内主要出血事件和指数住院期间症状性肺栓塞。共治疗 82 条肢体（78 例患者）（年龄 54.6±12.7 岁；32.1%为女性；平均 Villalta 评分 15.5±5.2）。主要终点在 64.6%（51/79）的患者中达到。1 年时，51/66（77.3%）条肢体的 Villalta 评分持续降低≥4 分。365 天时，超过 90%的节段超声显示有血流通过。基线至 1 年时，健康调查简表 36 项的生理成分综合评分从 38.9±9.5 增加到 45.2±9.8（≤0.0001），静脉疾病问卷生活质量评分从 61.9±19.7 增加到 82.6±20.8（1 年时，≤0.0001）。42 例患者行髂股静脉支架置入术，所有结局均显示出相似的改善，无论支架状态如何。1 例患者在介入后 72 小时内发生严重出血，术后 32 天死亡（死亡率为 1.3%）。
经皮腔内血管成形术和超声加速溶栓术成功地再通慢性静脉阻塞，改善了血栓后综合征的严重程度和生活质量。术后 1 年时结果仍持续。
