Oud Sharon, Alozai Tamana, Lam Yee Lai, Ünlü Çağdaş, Mooij Michael, Schreve Michiel A
Department of Surgery, Amsterdam University Medical Centre, Amsterdam, The Netherlands; Department of Surgery, Northwest Clinics, Alkmaar, The Netherlands.
Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
J Vasc Surg Venous Lymphat Disord. 2025 Jan;13(1):101967. doi: 10.1016/j.jvsv.2024.101967. Epub 2024 Sep 11.
The short-term anatomical success rates of mechanochemical ablation using the Clarivein device (Merit Medical) in the treatment of great saphenous vein (GSV) incompetence are high. However, the anatomical success rates seem to drop over time. The aim of this study was to determine the long-term outcomes of GSV treatment using the Clarivein and to assess whether specific anatomical features better correlate with clinical or quality of life (QoL)-related outcomes.
This is a single-center, prospective cohort study in follow-up of a multicenter, randomized controlled trial using Clarivein with liquid polidocanol for the treatment of GSV incompetence. The primary outcome was anatomical success (AS), defined as complete occlusion or a recanalized segment, irrespective of reflux, of <10 cm in length. In addition, reflux-free anatomical success (RF-AS) was determined, and defined as complete occlusion or a recanalized segment with <10 cm of reflux. Clinical success was assessed using the Venous Clinical Severity Score (VCSS), and QoL was assessed using the Dutch version of the Aberdeen Varicose Vein Questionnaire (DAVVQ) and the 36-Item Short Form Health Survey (SF-36). Subgroup analyses were performed based on whether AS or RF-AS was achieved or not.
A total of 109 patients (115 limbs) were included. The mean follow-up time was 8.4 ± 0.9 years (range, 5.5-10.3 years). AS was seen in 60.5% of limbs, and RF-AS was seen in 72.8% of limbs. Compared with baseline, the overall mean VCSS improved from 5.3 ± 2.4 to 4.1 ± 2.4, and the overall median DAVVQ score from 13.5 (interquartile range [IQR], 8.7-20.0) to 10.5 (IQR, 5.3-16.2) (P < .001). Improvement in VCSS was only significant in patients with successful treatment: from 5.5 ± 2.7 to 3.7 ± 2.5 (P < .001) if AS was achieved and from 5.0 ± 1.7 to 4.5 ± 1.9 (P = .20) if AS was not achieved. The same results were found for DAVVQ scores: improvement from13.5 (IQR, 8.7-20.6) to 10.3 (IQR, 3.0-14.5) (P < .01) if AS was achieved and from 12.9 (IQR, 8.3-19.3) to 10.8 (IQR, 6.7-18.2) (P = .35) if AS was not achieved. Regarding the overall SF-36 scores, the domains of vitality, mental health, and general health worsened significantly.
In over 8 years of follow-up, the anatomical success rate after the treatment of GSV incompetence using the Clarivein device decreased to 60.5%. However, clinical scores and disease-specific QoL still improved significantly compared with baseline. We found no convincing evidence that the absence of reflux correlates better with clinical and QoL-related outcomes compared with recanalization irrespective of reflux.
使用Clarivein装置（美力医疗公司）进行机械化学消融治疗大隐静脉（GSV）功能不全的短期解剖成功率较高。然而，解剖成功率似乎会随时间下降。本研究的目的是确定使用Clarivein治疗GSV的长期疗效，并评估特定的解剖特征是否与临床或生活质量（QoL）相关结局有更好的相关性。
这是一项单中心前瞻性队列研究，是对一项多中心随机对照试验的随访，该试验使用Clarivein联合聚多卡醇注射液治疗GSV功能不全。主要结局是解剖成功（AS），定义为完全闭塞或再通段长度<10 cm，无论有无反流。此外，还确定了无反流解剖成功（RF-AS），定义为完全闭塞或反流长度<10 cm的再通段。使用静脉临床严重程度评分（VCSS）评估临床成功，使用荷兰版阿伯丁静脉曲张问卷（DAVVQ）和36项简短健康调查（SF-36）评估QoL。根据是否实现AS或RF-AS进行亚组分析。
共纳入109例患者（115条肢体）。平均随访时间为8.4±0.9年（范围5.5 - 10.3年）。60.5%的肢体实现了AS，72.8%的肢体实现了RF-AS。与基线相比，总体平均VCSS从5.3±2.4改善至4.1±2.4，总体DAVVQ中位数评分从13.5（四分位间距[IQR]，8.7 - 20.0）改善至10.5（IQR，5.3 - 16.2）（P <.001）。仅在治疗成功的患者中VCSS有显著改善：实现AS的患者从5.5±2.7改善至3.7±2.5（P <.001），未实现AS的患者从5.0±1.7改善至4.5±1.9（P = 0.20）。DAVVQ评分也有相同结果：实现AS的患者从13.5（IQR，8.7 - 20.6）改善至10.3（IQR，3.0 - 14.5）（P <.01），未实现AS的患者从12.9（IQR，8.3 - 19.3）改善至10.8（IQR，6.7 - 18.2）（P = 0.35）。关于总体SF-36评分，活力、心理健康和总体健康领域显著恶化。
在超过8年的随访中，使用Clarivein装置治疗GSV功能不全后的解剖成功率降至60.5%。然而，与基线相比，临床评分和疾病特异性QoL仍有显著改善。我们没有发现令人信服的证据表明，与无论有无反流的再通相比，无反流与临床和QoL相关结局有更好的相关性。
