Tuleja Aleksandra, Döring Yvonne, Helfenstein Fabrice Noël, Andreoti Themis-Areti, Rössler Jochen, Boon Laurence Myriam, Vikkula Miikka, Haupt Fabian, Hamvas Györgyi, Bernhard Sarah Maike, Baumgartner Iris
Division of Angiology, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland.
Graduate School for Health Sciences, University of Bern, Bern, Switzerland.
Cardiovasc Diagn Ther. 2025 Jun 30;15(3):598-609. doi: 10.21037/cdt-24-529. Epub 2025 Jun 26.
Pain is one of the most important symptoms affecting quality of life in patients with venous malformations. Alcohol embolization is a common approach among other treatment modalities. However, the benefits and complications of this therapy require rigorous evaluation in the face of emerging alternative treatments. The aim of this study was to evaluate the efficacy of alcohol embolization in pain management compared with non-invasive treatment, and to explore associated complications.
We performed a retrospective, comparative study at the Vascular Malformation Center, University Hospital of Bern, from 2008 to 2022. Consecutive patients with peripheral venous malformations were included, one group underwent alcohol embolization and the other group received non-invasive treatment including counseling for compression stockings, physical therapy and anticoagulation. Decision to treat was made jointly by the clinician and the patient, after discussing the potential harms and benefits. Pain levels were measured using the 0-10 Numerical Rating Scale on every scheduled visit. Inverse probability of treatment weights were used to adjust for confounders such as severity of malformation indicated by number of tissues affected, localization, presence of hypertrophic tissue, history of thrombophlebitis, age, and level of pain at the initial visit. The primary outcome was change in maximal pain level, and secondary outcomes included changes in mean and minimal pain levels within 1 year of follow-up.
A total of 227 patients were included in the analysis, 86 in the intervention group and 141 in the control group. Over the course of one year, both the control and alcohol embolization groups experienced reductions in pain. The control group showed a reduction in maximal pain from 4.42 by 0.95 points, with an additional non-significant reduction of 0.99 points in the alcohol embolization group [estimate: -0.0027 per day, 95% confidence interval (CI): -0.0061, 0.0007, P=0.12]. However, alcohol embolization led to a more pronounced and significant reduction in mean and minimal pain, with additional reductions of 1.06 (-0.0029 per day, 95% CI: -0.0055, -0.0003, P=0.02) and 0.69 points per year (-0.0019 per day, 95% CI: -0.0035, -0.0004, P=0.01), respectively. Seven minor and five major complications occurred in the alcohol embolization group.
Non-invasive treatment helps patients with venous malformations to manage maximal pain effectively. Alcohol embolization results in a faster and more pronounced reduction in mean and minimal pain levels, but we found no statistical evidence of an advantage of alcohol embolization for reducing maximal pain. Treatment efficacy did not appear to be influenced by gender, age, or previous treatment history. To adequately assess the efficacy of new therapies, future trials should include both disease-specific, patient-reported outcome measures and a control group.
疼痛是影响静脉畸形患者生活质量的最重要症状之一。酒精栓塞是其他治疗方式中常用的一种方法。然而，面对新兴的替代治疗方法，这种疗法的益处和并发症需要进行严格评估。本研究的目的是评估酒精栓塞在疼痛管理方面与非侵入性治疗相比的疗效，并探讨相关并发症。
我们于2008年至2022年在伯尔尼大学医院血管畸形中心进行了一项回顾性比较研究。纳入连续的外周静脉畸形患者，一组接受酒精栓塞治疗，另一组接受非侵入性治疗，包括弹力袜使用咨询、物理治疗和抗凝治疗。在讨论潜在的危害和益处后，由临床医生和患者共同做出治疗决定。在每次预定就诊时，使用0至10数字评分量表测量疼痛程度。使用治疗权重的逆概率来调整混杂因素，如受影响组织数量所表明的畸形严重程度、部位、肥厚组织的存在、血栓性静脉炎病史、年龄以及初次就诊时的疼痛程度。主要结局是最大疼痛程度的变化，次要结局包括随访1年内平均和最小疼痛程度的变化。
共有227例患者纳入分析，干预组86例，对照组141例。在一年的时间里，对照组和酒精栓塞组的疼痛均有所减轻。对照组最大疼痛程度从4.42分降低了0.95分，酒精栓塞组额外有0.99分的非显著降低[估计值：每天-0.0027，95%置信区间（CI）：-0.0061，0.0007，P = 0.12]。然而，酒精栓塞导致平均和最小疼痛程度有更明显且显著的降低，每年分别额外降低1.06分（每天-0.0029，95% CI：-0.0055，-0.0003，P = 0.02）和0.69分（每天-0.0019，95% CI：-0.0035，-0.0004，P = 0.01）。酒精栓塞组发生了7例轻微并发症和5例严重并发症。
非侵入性治疗有助于静脉畸形患者有效控制最大疼痛程度。酒精栓塞能使平均和最小疼痛程度更快且更显著地降低，但我们没有发现酒精栓塞在降低最大疼痛程度方面具有优势的统计学证据。治疗效果似乎不受性别、年龄或既往治疗史的影响。为了充分评估新疗法的疗效，未来的试验应包括疾病特异性、患者报告的结局指标以及一个对照组。
