Zouzos Athanasios, Fredriksson Irma, Karakatsanis Andreas, Foukakis Theodoros, Strand Fredrik
Department of Radiology, Karolinska University Hospital, Stockholm, Sweden; Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.
Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden; Department of Breast-, Endocrine Tumors and Sarcoma, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden.
Eur J Radiol. 2025 May;186:112062. doi: 10.1016/j.ejrad.2025.112062. Epub 2025 Mar 19.
Vacuum-assisted excision (VAE) of benign breast lesions is increasingly adopted owing to its clinical performance and convenience. However, the potential complications, impact on patient experience, and healthcare costs need to be thoroughly addressed, which is the focus of this study.
The Swedish VAE trial was a prospective, single-blind, randomised trial. The patients were randomised to 7G or 10G needle size groups, and VAE was performed under ultrasound or mammographic guidance. Patient acceptance of the method and short-term complications were documented 7 and 15 days after the procedure. Long-term follow-up examinations were performed at 6 and 24 months after the procedure. The total procedural costs were calculated and compared with those of open surgical excision (OSE), the previous standard of care for surgical procedures.
In the trial, VAE was performed on 208 patients, of whom 178 answered a questionnaire regarding their experience. Among those, 87 and 91 had their procedure performed with a 7G and 10G needle, respectively. There were no significant differences in pain levels (p = 0.713), complications (p = 0.724), or patient acceptance of the procedure between the two groups (p = 0.401). Fifty-five per cent (98/178) of all patients reported pain levels < 2 on a visual -analogue scale ranging from 1 to 10, while 12 per cent (21/178) reported pain levels > 6. Ninety-seven per cent (173/178) of the patients would recommend the procedure to others. The total hospital procedural cost of VAE was estimated to be 60 % lower than the cost of OSE (p < 0.001).
The VAE procedure using a 7G needle size was well -accepted by patients and conferred no increase in complications, including pain, compared to a 10G needle size. The VAE procedure had superior cost-efficiency compared to OSE.
由于其临床性能和便利性,真空辅助切除(VAE)良性乳腺病变的方法越来越多地被采用。然而,其潜在并发症、对患者体验的影响以及医疗成本需要得到全面解决,这是本研究的重点。
瑞典VAE试验是一项前瞻性、单盲、随机试验。患者被随机分为7G或10G针径组,并在超声或乳腺X线引导下进行VAE。在术后7天和15天记录患者对该方法的接受程度和短期并发症。在术后6个月和24个月进行长期随访检查。计算了总手术成本,并与开放手术切除(OSE)(此前手术治疗的标准方法)的成本进行了比较。
在该试验中,对208例患者进行了VAE,其中178例回答了关于其体验的问卷。其中,分别有87例和91例患者使用7G和10G针进行了手术。两组在疼痛程度(p = 0.713)、并发症(p = 0.724)或患者对手术的接受程度(p = 0.401)方面均无显著差异。在视觉模拟量表(范围为1至10)上,所有患者中有55%(98/178)报告疼痛程度<2,而12%(21/178)报告疼痛程度>6。97%(173/178)的患者会向他人推荐该手术。VAE的总住院手术成本估计比OSE低60%(p < 0.001)。
与10G针径相比,使用7G针径的VAE手术患者接受度良好,且包括疼痛在内的并发症并未增加。与OSE相比,VAE手术具有更高的成本效益。