Kolvenbach Ralf R, Elias Steven, Belinky Alex, Brandeis Zeev
Vascular Centre Catholic Hospital Group Duesseldorf, Augusta Hospital, Duesseldorf, Federal Republic of Germany.
Center for Vein Disease, Englewood Hospital and Medical Center, Englewood, CO.
Ann Vasc Surg. 2019 Aug;59:231-236. doi: 10.1016/j.avsg.2019.01.025. Epub 2019 Apr 19.
The procedure aims to show our results with a novel nontumescent, nonthermal technique to treat varicose veins. The V-block occlusion stent is a minimally invasive device for treating reflux of the great saphenous vein (GSV). It is an office-based procedure that does not require tumescence anesthesia. The V-block stent is a self-expandable device that functions as a vein occluder and blood clot trap. Once the V-block is in place, further treatment of the saphenous vein such as ultrasound-guided sclerotherapy can be performed. The V-block device is intended to eliminate the possibility of forwarding passage of clot and sclerosant (embolization) to the deep and pulmonary circulations.
Patients were treated in an outpatient setting with the V-block occluding device. Follow-up was performed using duplex ultrasound to assess occlusion of the saphenous vein as well as the Aberdeen Varicose Vein Questionnaire and Venous Severity Scoring to determine changes in quality of life after the procedure. Patients were followed up at 1 week, 1 month, and 3 months after V-block placement. Duplex scanning was performed to confirm GSV occlusion at all follow-up visits. After deployment of the occlusion stent, a maximum of 2% polidocanol foam was injected with a double barrel syringe which simultaneously evacuated blood from the greater saphenous vein. Follow-up assessment for safety included evaluation of potential complications, device migration, and potential injury at the deployment site.
Fifty-one symptomatic subjects with documented GSV reflux were enrolled in the study. Complete occlusion of the GSV was achieved in 98% of the patients during the 7-day postprocedural visit. There was no injury at the deployment site. No migration of the V-block device was observed. No deep vein thrombosis or any other complication was recorded. One patient of the 50 patients and 51 procedures experienced an adverse event, phlebitis that resolved under conservative therapy within 4 days with no residual effect. There was a significant improvement in the Aberdeen Vein quality of life measurements and the pain scores. After 3 years, 18 patients were willing to undergo a duplex follow-up examination. The occlusion rate after 3 years was 77.8. There were no device-related complications after this period.
The study demonstrated a good safety and performance profile without any major adverse events. The primary end point of vein occlusion and obliteration was met.
本手术旨在展示我们使用一种新型非肿胀、非热技术治疗静脉曲张的结果。V 型封堵支架是一种用于治疗大隐静脉（GSV）反流的微创装置。这是一种在门诊进行的手术，无需肿胀麻醉。V 型封堵支架是一种自膨胀装置，兼具静脉封堵器和血栓捕捉器的功能。一旦 V 型封堵器就位，即可对大隐静脉进行进一步治疗，如超声引导下硬化治疗。V 型封堵装置旨在消除血栓和硬化剂向前进入深静脉和肺循环（栓塞）的可能性。
使用 V 型封堵装置在门诊对患者进行治疗。采用双功超声进行随访，以评估大隐静脉的闭塞情况，并使用阿伯丁静脉曲张问卷和静脉严重程度评分来确定术后生活质量的变化。在放置 V 型封堵器后的 1 周、1 个月和 3 个月对患者进行随访。在所有随访中均进行双功扫描以确认 GSV 闭塞。在部署封堵支架后，用双筒注射器注射最大 2%的聚多卡醇泡沫，同时从大隐静脉抽出血液。安全性的随访评估包括对潜在并发症、装置移位以及部署部位潜在损伤的评估。
51 名有记录的 GSV 反流症状患者纳入本研究。98%的患者在术后 7 天的随访中实现了 GSV 的完全闭塞。部署部位未出现损伤。未观察到 V 型封堵装置移位。未记录到深静脉血栓形成或任何其他并发症。在 50 名患者的 51 次手术中，有 1 名患者发生了不良事件，即静脉炎，在保守治疗下 4 天内消退，无残留影响。阿伯丁静脉生活质量测量和疼痛评分有显著改善。3 年后，18 名患者愿意接受双功超声随访检查。3 年后的闭塞率为 77.8%。在此期间未出现与装置相关的并发症。
本研究表明该技术安全性良好、性能优良，未发生任何重大不良事件。达到了静脉闭塞和消除的主要终点。
