1 Vascular Institute Central Switzerland, Aarau, Switzerland.
2 Department of Cardiology, Bern University Hospital, Bern, Switzerland.
J Endovasc Ther. 2019 Apr;26(2):181-190. doi: 10.1177/1526602819829903. Epub 2019 Feb 11.
To report the 1-year outcomes of a single-center, all-comers registry aimed to assess effectiveness and safety of endovascular revascularization for atherosclerotic erectile dysfunction (ED) in an unselected patient cohort.
Between April 2016 and October 2017, 50 consecutive patients (mean age 59.6±10.3 years) underwent endovascular revascularization for ED owing to >50% stenosis in 82 erection-related arteries. Patients were treated by means of standard balloon angioplasty (16%), drug-coated balloon angioplasty (27%), or drug-eluting stent (55%) implantation. The primary feasibility outcome measure was the incidence of a minimum clinically relevant improvement of ≥4 in the 6-question International Index of Erectile Function Questionnaire (IIEF-6) score at 12 months. Clinical effectiveness was improvement in erectile function as quantified in the mean difference (MD) of the IIEF-15 score at 3 and 12 months as well as the mean changes in IIEF-15 questions 3 and 4.
Procedure success was achieved in 49 (98%) of 50 patients. At 12 months, 30 (65%) of 46 patients achieved a minimum clinically relevant improvement in the IIEF-6 score. The overall IIEF-15 score, as well as scores for questions 3 and 4, improved in 32 (65%) of 49 patients, 28 (57%) of 49 patients, and 29 (60%) of 48 patients, respectively. Change in the overall IIEF-15 score at 12 months was consistent among subgroups, except for elderly patients [MD -5.0 (95% CI -9.7 to -0.2), p=0.041] and those with hypertension [MD -11.0 (95% CI -20.5 to -1.5), p=0.025], who showed less improvement.
Endovascular revascularization was safe and efficacious in the majority of ED patients through 1 year.
报告一项单中心、所有患者入组的登记研究结果,旨在评估血管内血运重建术治疗非选择性患者中动脉粥样硬化性勃起功能障碍(ED)的有效性和安全性。
2016 年 4 月至 2017 年 10 月,50 例连续患者(平均年龄 59.6±10.3 岁)因 82 条与勃起相关的动脉中>50%狭窄而接受 ED 的血管内血运重建治疗。患者接受标准球囊血管成形术(16%)、药物涂层球囊血管成形术(27%)或药物洗脱支架(55%)植入治疗。主要可行性结局指标是在 12 个月时,国际勃起功能指数问卷(IIEF-6)评分至少增加 4 分的最小临床相关改善的发生率。临床疗效通过 3 个月和 12 个月时 IIEF-15 评分的平均差值(MD)以及 IIEF-15 问卷第 3 和第 4 项的平均变化来量化。
50 例患者中,49 例(98%)手术成功。在 12 个月时,46 例患者中有 30 例(65%)IIEF-6 评分达到最小临床相关改善。49 例患者中 32 例(65%)、49 例患者中 28 例(57%)和 48 例患者中 29 例(60%)的总体 IIEF-15 评分以及第 3 和第 4 项问题的评分均有所改善。除了老年患者[MD-5.0(95%CI-9.7 至-0.2),p=0.041]和高血压患者[MD-11.0(95%CI-20.5 至-1.5),p=0.025]外,12 个月时总体 IIEF-15 评分的变化在各亚组中是一致的,这两组患者的改善程度较低。
血管内血运重建术在大多数 ED 患者中安全且在 1 年内有效。