Abstract：
BACKGROUND: Polidocanol endovenous microfoam (PEM) has been used to treat lower extremity venous reflux for almost one decade with specific advantages for below knee (BK) truncal veins where thermal ablation poses a risk of injury to adjacent nerves. The current literature of the BK segment often examines short-term outcomes with modest sample sizes. We aim to identify factors associated with recanalization and reintervention in this subset of patients.
METHODS: We performed a retrospective study of a prospectively maintained database of patients from a single institution who underwent 1% PEM ablation for BK great saphenous vein (GSV) and small saphenous vein (SSV) reflux. Patients underwent duplex ultrasound (DU) within 7 days after injection, every 3 to 6 months for 1 year, and every 6 to 12 months thereafter. Patients with symptomatic recanalization underwent reintervention. The 26 patients lost to follow-up without DU after ablation were excluded. The factors associated with recanalization and reintervention were examined by multivariate and nonparametric analyses.
RESULTS: Between March 2018 and July 2023, 411 patients (166 male, 245 female) with 573 treated limbs (284 right, 289 left) met the study criteria. Of the 573 included limbs, 457 (79.8%) had undergone prior above knee saphenous ablations. A total of 554 BK GSV and 42 SSV ablations were performed. The most recent DU was performed at a mean of 231 ± 329 days. The overall recanalization rate was 10.6% (55 GSVs and 8 SSVs) at a mean follow-up of 104 ± 180 days. Comparing the closed and recanalized veins, we found no significant difference in age (P = .90), treated laterality (P = .14), patient body mass index (P = .59), preprocedural CEAP (clinical-etiology-anatomy-pathophysiology) score (P = .79), recanalization rate in GSVs vs SSVs (P = .06), or administered PEM volume (P = .24). The recanalized veins had significantly larger preprocedural diameters than the veins that remained closed (recanalized, 4.9 mm; closed, 4.3 mm; P = .001). Men had higher incidence of recanalization than women (men, 14.2%; women, 8%; P = .015). Anticoagulation use was associated with recanalization (odds ratio, 1.96; 95% confidence interval, 1.1-3.6; P = .03). Early recanalization at the first DU accounted for 31 failures (49.2%) and had a significantly lower administered PEM volume compared with later recanalization (early, 4 mL; late, 5 mL; P = .025). There were no significant differences between the 33 recanalized patients requiring reintervention (52.4%) and the 30 who did not. Twenty-four reinterventions were performed with PEM, 100% of which remained closed at a median of 160 days (interquartile range, 257 days).
CONCLUSIONS: PEM is successful for the treatment of BK GSV and SSV reflux with a closure rate of 89% at a mean of 231 days and shows promise as salvage therapy. Most cases of recanalization were noted in the early postprocedure period and were associated with a lower PEM volume. A larger vein diameter, male sex, and anticoagulation use are associated with higher rates of recanalization.
METHODS: We performed a retrospective study of a prospectively maintained database of patients from a single institution who underwent 1% PEM ablation for BK great saphenous vein (GSV) and small saphenous vein (SSV) reflux. Patients underwent duplex ultrasound (DU) within 7 days after injection, every 3 to 6 months for 1 year, and every 6 to 12 months thereafter. Patients with symptomatic recanalization underwent reintervention. The 26 patients lost to follow-up without DU after ablation were excluded. The factors associated with recanalization and reintervention were examined by multivariate and nonparametric analyses.
RESULTS: Between March 2018 and July 2023, 411 patients (166 male, 245 female) with 573 treated limbs (284 right, 289 left) met the study criteria. Of the 573 included limbs, 457 (79.8%) had undergone prior above knee saphenous ablations. A total of 554 BK GSV and 42 SSV ablations were performed. The most recent DU was performed at a mean of 231 ± 329 days. The overall recanalization rate was 10.6% (55 GSVs and 8 SSVs) at a mean follow-up of 104 ± 180 days. Comparing the closed and recanalized veins, we found no significant difference in age (P = .90), treated laterality (P = .14), patient body mass index (P = .59), preprocedural CEAP (clinical-etiology-anatomy-pathophysiology) score (P = .79), recanalization rate in GSVs vs SSVs (P = .06), or administered PEM volume (P = .24). The recanalized veins had significantly larger preprocedural diameters than the veins that remained closed (recanalized, 4.9 mm; closed, 4.3 mm; P = .001). Men had higher incidence of recanalization than women (men, 14.2%; women, 8%; P = .015). Anticoagulation use was associated with recanalization (odds ratio, 1.96; 95% confidence interval, 1.1-3.6; P = .03). Early recanalization at the first DU accounted for 31 failures (49.2%) and had a significantly lower administered PEM volume compared with later recanalization (early, 4 mL; late, 5 mL; P = .025). There were no significant differences between the 33 recanalized patients requiring reintervention (52.4%) and the 30 who did not. Twenty-four reinterventions were performed with PEM, 100% of which remained closed at a median of 160 days (interquartile range, 257 days).
CONCLUSIONS: PEM is successful for the treatment of BK GSV and SSV reflux with a closure rate of 89% at a mean of 231 days and shows promise as salvage therapy. Most cases of recanalization were noted in the early postprocedure period and were associated with a lower PEM volume. A larger vein diameter, male sex, and anticoagulation use are associated with higher rates of recanalization.
摘要：
背景：Polidocanol静脉内微泡沫（PEM）已用于治疗下肢静脉返流近十年，在膝下（BK）躯干静脉中具有特殊优势，其中热消融会对相邻神经造成损伤。BK部分的当前文献通常以适度的样本量来检查短期结果。我们的目标是确定与这一子集患者的再通和再干预相关的因素。
方法：我们对一个接受了BK大隐静脉（GSV）和小隐静脉（SSV）反流PEM消融术的单一机构的患者进行了前瞻性维护数据库的回顾性研究。患者在注射后7天内接受了双工超声检查（DU），一年中每3-6个月,此后每6-12个月。有症状的再通患者接受了再干预。排除了26例未接受消融后DU随访的患者。通过多变量和非参数分析检查了与再通和再干预相关的因素。
结果：2018年3月至2023年7月，411（166名男性，245名女性）患者，有573名接受治疗的四肢（284右，289左)符合研究标准。79.8％（457）的包括肢体先前进行了AK隐消融。进行554BKGSV和42SSV消融。最近的DU在平均231天进行(SD=329)。总体再通率为10.6%(55GSV，8SSV），平均随访104天（SD=180）。比较闭合静脉和再通静脉，年龄差异无统计学意义(p=0.90),处理后的侧向性(p=0.14)，患者BMI（p=0.59），术前CEAP评分（p=0.79），GSV与SSV的再通率（p=0.06），或施用的PEM体积(p=0.24)。再通静脉的术前直径明显大于保持闭合的静脉（4.9mm，4.3mm关闭,p=0.001)。男性再通发生率高于女性(男性14.2%,8%女性,p=0.015)。抗凝使用与再通相关(赔率比[OR]，1.96；95%CI，1.1-3.6，p=0.03)。早期再通在第一次DU占49.2%（31）的失败，有显著较低的PEM施药量相比，后来再通（早期4cc，晚5cc，p=0.025)。在需要再次干预的52.4％（33）的再通患者和没有再次干预的患者（30）之间没有发现显着差异。用PEM进行了24次再干预，其中100％保持关闭，中位数为160天（IQR=257）。
结论：PEM成功治疗BKGSV和SSV反流，平均231天的闭合率为89％，并显示出挽救治疗的希望。在术后早期发现了大多数再造影，并且与较低的PEM体积有关。静脉直径较大，男性,抗凝的使用与较高的再通率相关。
方法：我们对一个接受了BK大隐静脉（GSV）和小隐静脉（SSV）反流PEM消融术的单一机构的患者进行了前瞻性维护数据库的回顾性研究。患者在注射后7天内接受了双工超声检查（DU），一年中每3-6个月,此后每6-12个月。有症状的再通患者接受了再干预。排除了26例未接受消融后DU随访的患者。通过多变量和非参数分析检查了与再通和再干预相关的因素。
结果：2018年3月至2023年7月，411（166名男性，245名女性）患者，有573名接受治疗的四肢（284右，289左)符合研究标准。79.8％（457）的包括肢体先前进行了AK隐消融。进行554BKGSV和42SSV消融。最近的DU在平均231天进行(SD=329)。总体再通率为10.6%(55GSV，8SSV），平均随访104天（SD=180）。比较闭合静脉和再通静脉，年龄差异无统计学意义(p=0.90),处理后的侧向性(p=0.14)，患者BMI（p=0.59），术前CEAP评分（p=0.79），GSV与SSV的再通率（p=0.06），或施用的PEM体积(p=0.24)。再通静脉的术前直径明显大于保持闭合的静脉（4.9mm，4.3mm关闭,p=0.001)。男性再通发生率高于女性(男性14.2%,8%女性,p=0.015)。抗凝使用与再通相关(赔率比[OR]，1.96；95%CI，1.1-3.6，p=0.03)。早期再通在第一次DU占49.2%（31）的失败，有显著较低的PEM施药量相比，后来再通（早期4cc，晚5cc，p=0.025)。在需要再次干预的52.4％（33）的再通患者和没有再次干预的患者（30）之间没有发现显着差异。用PEM进行了24次再干预，其中100％保持关闭，中位数为160天（IQR=257）。
结论：PEM成功治疗BKGSV和SSV反流，平均231天的闭合率为89％，并显示出挽救治疗的希望。在术后早期发现了大多数再造影，并且与较低的PEM体积有关。静脉直径较大，男性,抗凝的使用与较高的再通率相关。
