Purpose: 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.
Materials and methods: 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.
Results: 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.
Conclusion: Endovascular revascularization was safe and efficacious in the majority of ED patients through 1 year.
Keywords: angioplasty; atherosclerosis; drug-coated balloon; drug-eluting stent; endovascular treatment; erectile dysfunction; internal pudendal artery; revascularization; stenosis.