Abstract：
OBJECTIVE: Patient characteristics and risk factors for incomplete or non-closure following thermal saphenous vein ablation have been reported. However, similar findings have not been clearly described following commercially manufactured polidocanol microfoam ablation (MFA). The objective of our study is to identify predictive factors and outcomes associated with non-closure following MFA of symptomatic, refluxing saphenous veins.
METHODS: A retrospective review of a prospectively maintained patient database was performed from procedures in our Ambulatory Procedure Unit. All consecutive patients who underwent MFA with commercially manufactured 1% polidocanol microfoam for symptomatic superficial vein reflux between June 2018 and September 2022 were identified. Patients treated for tributary veins only, without truncal vein ablation, were excluded. Patients were then stratified into groups: complete closure (Group I) and non-closure (Group II). Preoperative demographics, procedural details, and postoperative outcomes were analyzed. Preoperative variables that were significant on univariate analysis (prior deep venous thrombosis [DVT], body mass index [BMI] ≥30 kg/m2, and vein diameter) were entered into a multivariate logistic regression model with the primary outcome being vein non-closure.
RESULTS: Between June 2018 and September 2022, a total of 224 limbs underwent MFA in our ambulatory venous center. Of these, 127 limbs in 103 patients met study inclusion criteria. Truncal veins treated included the above-knee great saphenous vein (Group I: n = 89, 77% vs Group II: n = 7, 58%; P = .14), below-knee great saphenous vein (Group I: n = 7, 6% vs Group II: n = 0; P = .38), anterior accessory saphenous vein (Group I: n = 17, 15% vs Group II: n = 4, 33%; P = .12, and small saphenous vein (Group I: n = 4, 4% vs Group II: n = 1, 8%; P = .41). Complete closure (Group I) occurred in 115 limbs, and 12 limbs did not close (Group II) based on postoperative duplex ultrasound screening. The mean BMI in Group II (36.1 ± 6.4 kg/m2) was significantly greater than Group I (28.6 ± 6.1 kg/m2) (P < .001). Vein diameter of ≥10.2 mm was independently associated with truncal vein non-closure with an odds ratio of 4.8. The overall mean foam volume was 6.2 ± 2.7 ml and not different between the two cohorts (Group I: 6.2 ± 2.6 ml vs Group II: 6.3 + 3.5 ml; P = .89). Post MFA improvement in symptoms was higher in Group I (96.9%) compared with Group II (66.7%) (P = .001). The mean postoperative Venous Clinical Severity Score was also lower in Group I (8.0 ± 3.0) compared with Group II (9.9 ± 4.2) (P = .048). The overall incidences of ablation-related thrombus extension and DVT were 4.7% (n = 6) and 1.6% (n = 2), and all occurred in Group I. All were asymptomatic and resolved with anticoagulation.
CONCLUSIONS: Microfoam ablation of symptomatic, refluxing truncal veins results in excellent overall closure rates and symptomatic relief. BMI ≥30 kg/m2 and increased vein diameter are associated with an increased risk of saphenous vein non-closure following MFA. Non-closure is associated with less symptomatic improvement and a lower post-procedure reduction in Venous Clinical Severity Score. Despite the incidence of ablation-related thrombus extension and DVT in this study being higher than reported rates following thermal ablation, MFA is safe for patients with early postoperative duplex ultrasound surveillance and selective short-term anticoagulation.
METHODS: A retrospective review of a prospectively maintained patient database was performed from procedures in our Ambulatory Procedure Unit. All consecutive patients who underwent MFA with commercially manufactured 1% polidocanol microfoam for symptomatic superficial vein reflux between June 2018 and September 2022 were identified. Patients treated for tributary veins only, without truncal vein ablation, were excluded. Patients were then stratified into groups: complete closure (Group I) and non-closure (Group II). Preoperative demographics, procedural details, and postoperative outcomes were analyzed. Preoperative variables that were significant on univariate analysis (prior deep venous thrombosis [DVT], body mass index [BMI] ≥30 kg/m2, and vein diameter) were entered into a multivariate logistic regression model with the primary outcome being vein non-closure.
RESULTS: Between June 2018 and September 2022, a total of 224 limbs underwent MFA in our ambulatory venous center. Of these, 127 limbs in 103 patients met study inclusion criteria. Truncal veins treated included the above-knee great saphenous vein (Group I: n = 89, 77% vs Group II: n = 7, 58%; P = .14), below-knee great saphenous vein (Group I: n = 7, 6% vs Group II: n = 0; P = .38), anterior accessory saphenous vein (Group I: n = 17, 15% vs Group II: n = 4, 33%; P = .12, and small saphenous vein (Group I: n = 4, 4% vs Group II: n = 1, 8%; P = .41). Complete closure (Group I) occurred in 115 limbs, and 12 limbs did not close (Group II) based on postoperative duplex ultrasound screening. The mean BMI in Group II (36.1 ± 6.4 kg/m2) was significantly greater than Group I (28.6 ± 6.1 kg/m2) (P < .001). Vein diameter of ≥10.2 mm was independently associated with truncal vein non-closure with an odds ratio of 4.8. The overall mean foam volume was 6.2 ± 2.7 ml and not different between the two cohorts (Group I: 6.2 ± 2.6 ml vs Group II: 6.3 + 3.5 ml; P = .89). Post MFA improvement in symptoms was higher in Group I (96.9%) compared with Group II (66.7%) (P = .001). The mean postoperative Venous Clinical Severity Score was also lower in Group I (8.0 ± 3.0) compared with Group II (9.9 ± 4.2) (P = .048). The overall incidences of ablation-related thrombus extension and DVT were 4.7% (n = 6) and 1.6% (n = 2), and all occurred in Group I. All were asymptomatic and resolved with anticoagulation.
CONCLUSIONS: Microfoam ablation of symptomatic, refluxing truncal veins results in excellent overall closure rates and symptomatic relief. BMI ≥30 kg/m2 and increased vein diameter are associated with an increased risk of saphenous vein non-closure following MFA. Non-closure is associated with less symptomatic improvement and a lower post-procedure reduction in Venous Clinical Severity Score. Despite the incidence of ablation-related thrombus extension and DVT in this study being higher than reported rates following thermal ablation, MFA is safe for patients with early postoperative duplex ultrasound surveillance and selective short-term anticoagulation.
摘要：
目的：已经报道了热大隐静脉消融后不完全或未闭合的患者特征和危险因素。然而,商业制造的脊髓灰质炎微泡沫消融(MFA)后,类似的发现尚未得到明确描述.我们研究的目的是确定与症状性MFA后未闭合相关的预测因素和结局，回流的隐静脉。
方法：根据我们的门诊手术单元（APU）的手术，对前瞻性维护的患者数据库进行了回顾性回顾。在2018年6月至2022年9月期间，所有连续患者均接受了商业制造的1％polidocanol微泡沫的MFA，用于有症状的浅静脉反流。仅治疗支流静脉的患者，没有截断静脉消融，被排除在外。然后将患者分层成组:完全闭合(组I)和非闭合(组II)。术前人口统计学,手术细节和术后结果分析。单变量分析有意义的术前变量(既往DVT，BMI≥30，静脉直径）进入多变量逻辑回归模型，主要结果是静脉未闭合。
结果：在2018年6月至2022年9月之间，我们的动态静脉中心共有224条肢体接受了MFA。其中,103例患者中的127条肢体符合研究纳入标准。治疗的干静脉包括膝关节以上GSV（I组：n=89，77％vs.II组：N=7，58％；p=0.14），低于膝盖GSV(第一组：N=7，6%vs.II组：N=0；p=0.38），AASV(第一组：n=17，15%vs.II组：n=4，33％；p=0.12，和SSV（I组：4，4％vs.II组：n=1，8％；p=0.41）。根据术后双工超声筛查，完全闭合（I组）发生在115条肢体和12条肢体未闭合（II组）。II组的平均BMI(36.1±6.4kg/m2)显著大于I组(28.6±6.1kg/m2)(p<0.001)。静脉直径≥10.2mm与躯干静脉未闭合独立相关，比值比为4.8。总体平均泡沫体积为6.2±2.7ml，两组之间没有差异（第I组：6.2±2.6ml与II组：6.3+3.5ml；p=0.89）。与II组（66.7％）相比，I组（96.9％）的MFA后症状改善更高（P=0.001）。与II组（9.9±4.2）相比，I组（8.0±3.0）的平均术后VCSS也较低（p=0.048）。消融相关的血栓扩展（ARTE）和DVT的总发生率分别为4.7％（n=6）和1.6％（n=2），均发生在I组中。均无症状并通过抗凝治疗解决。
结论：微泡沫消融对症，回流的躯干静脉导致极好的整体闭合率和症状缓解。体重指数≥30和静脉直径增加与MFA后隐静脉未闭合的风险增加相关。非闭合与较少的症状改善和较低的术后VCSS减少相关。尽管本研究中ARTE和DVT的发生率高于热消融后报告的发生率，MFA对于早期PDUS监测和选择性短期抗凝治疗的患者是安全的。
方法：根据我们的门诊手术单元（APU）的手术，对前瞻性维护的患者数据库进行了回顾性回顾。在2018年6月至2022年9月期间，所有连续患者均接受了商业制造的1％polidocanol微泡沫的MFA，用于有症状的浅静脉反流。仅治疗支流静脉的患者，没有截断静脉消融，被排除在外。然后将患者分层成组:完全闭合(组I)和非闭合(组II)。术前人口统计学,手术细节和术后结果分析。单变量分析有意义的术前变量(既往DVT，BMI≥30，静脉直径）进入多变量逻辑回归模型，主要结果是静脉未闭合。
结果：在2018年6月至2022年9月之间，我们的动态静脉中心共有224条肢体接受了MFA。其中,103例患者中的127条肢体符合研究纳入标准。治疗的干静脉包括膝关节以上GSV（I组：n=89，77％vs.II组：N=7，58％；p=0.14），低于膝盖GSV(第一组：N=7，6%vs.II组：N=0；p=0.38），AASV(第一组：n=17，15%vs.II组：n=4，33％；p=0.12，和SSV（I组：4，4％vs.II组：n=1，8％；p=0.41）。根据术后双工超声筛查，完全闭合（I组）发生在115条肢体和12条肢体未闭合（II组）。II组的平均BMI(36.1±6.4kg/m2)显著大于I组(28.6±6.1kg/m2)(p<0.001)。静脉直径≥10.2mm与躯干静脉未闭合独立相关，比值比为4.8。总体平均泡沫体积为6.2±2.7ml，两组之间没有差异（第I组：6.2±2.6ml与II组：6.3+3.5ml；p=0.89）。与II组（66.7％）相比，I组（96.9％）的MFA后症状改善更高（P=0.001）。与II组（9.9±4.2）相比，I组（8.0±3.0）的平均术后VCSS也较低（p=0.048）。消融相关的血栓扩展（ARTE）和DVT的总发生率分别为4.7％（n=6）和1.6％（n=2），均发生在I组中。均无症状并通过抗凝治疗解决。
结论：微泡沫消融对症，回流的躯干静脉导致极好的整体闭合率和症状缓解。体重指数≥30和静脉直径增加与MFA后隐静脉未闭合的风险增加相关。非闭合与较少的症状改善和较低的术后VCSS减少相关。尽管本研究中ARTE和DVT的发生率高于热消融后报告的发生率，MFA对于早期PDUS监测和选择性短期抗凝治疗的患者是安全的。
