Microwave versus endovenous laser in great saphenous vein ablation: a randomized controlled clinical study

Tamer E. Abd-Allah, Mostafa S. M. Abdelbary, Mina G. Zekri, Karim S. M. El-Awady
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Abstract

Due to the global burden of varicose veins (VVs) and the impact on the quality of life (QoL) of patients, it is essential to search for better treatment modalities. The main objective of this research was to compare the efficacy, safety, and impact on the QoL of endovenous microwave ablation (EMA) and endovenous laser ablation (EVLA) for the management of varicose veins of the great saphenous vein (GSV). A comparative, multicenter, single-blinded, parallel randomized controlled study conducted on 340 patients confirmed to have primary VVs of the GSV who were further randomized into two groups. The study group (n=170) received EMA, and the control group (n=170) received EVLA. Both the study group and the control group were comparable with regard to their baseline characteristics (P values > 0.05). The study group and the control group were comparable with regard to the limb affected (P=0.184). Only 14.7% and 10.0% of the study group and the control group have both limbs affected. Both the study group and the control group were comparable with regard to CEAP classification (P=0. 068). The study group and the control group were significantly different with regard to operating time (P<0.001). The operating time is less in the study group than in the control group. The median (IQR) and the mean±SD of the operating time was 7 (4) and 8.7±4.1 min in the study (microwave) group and 9 (5) and 10±3.9 min in the control group. Also, the study group and the control group showed 100% success at the 1-week evaluation as none of the cases in both groups suffered recanalization. At 6-month evaluation, only 1 case in the study group and 2 cases of the control group experienced recanalization; however, the difference is not significant (P=0.537). At the 12-month evaluation, the study group and the control group showed 100% success as none of the cases in both groups suffered recanalization. QoL is better in the study group than the control group at 6 months Aberdeen score (P=< 0.001). The median IQR and the mean±SD of the postoperative Aberdeen score were 9 (2.7) and 9.3±1.7 in the study (microwave) group and 10.8 (3.4) and 10.8±1.8 in the control group. Moreover, the study group and the control group were comparable (P values > 0.05) with regard to adverse events except for paresthesia (P-value = 0.025). About 11.2% of the control group experienced paresthesia versus only 2.9% of the study group. In conclusion, EMA has a lower operating time than EVLA. EMA is as effective as EVLA for treating VVS of the GSV. EMA has fewer adverse events than EVLA. EMA has better QoL than EVLA ablation. However, the choice of treatment should be based on individual patient characteristics and the expertise of the treating physician.
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微波与静脉腔内激光在大隐静脉消融中的应用:随机对照临床研究
由于静脉曲张(VVs)给全球带来的负担以及对患者生活质量(QoL)的影响,寻找更好的治疗方法至关重要。 这项研究的主要目的是比较静脉腔内微波消融术(EMA)和静脉腔内激光消融术(EVLA)治疗大隐静脉曲张的疗效、安全性和对生活质量的影响。 这是一项多中心、单盲、平行随机对照对比研究,研究对象是 340 名确认患有原发性大隐静脉曲张的患者,他们被随机分为两组。研究组(170 人)接受 EMA 治疗,对照组(170 人)接受 EVLA 治疗。 研究组和对照组的基线特征具有可比性(P 值 > 0.05)。研究组和对照组的受累肢体具有可比性(P=0.184)。研究组和对照组中分别只有 14.7% 和 10.0% 的患者双侧肢体均受影响。研究组和对照组在 CEAP 分类方面具有可比性(P=0.068)。在手术时间方面,研究组和对照组有显著差异(P 0.05);在不良反应方面,研究组和对照组除麻痹外(P 值 = 0.025)均无显著差异(P 0.05)。对照组中约有 11.2% 出现麻痹,而研究组中仅有 2.9%。 总之,EMA 的手术时间比 EVLA 短。EMA 在治疗 GSV 的 VVS 方面与 EVLA 一样有效。EMA 的不良反应少于 EVLA。EMA的生活质量优于EVLA消融术。然而,治疗方法的选择应基于患者的个体特征和主治医生的专业知识。
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