A study from Taiwan, published in EuroIntervention in May and presented at the EuroPCR congress (20–23 May 2014, Paris, France), shows that penile artery angioplasty is safe and can achieve clinically significant improvement in erectile function in 60% of patients with erectile dysfunction and isolated penile artery stenosis at six months.
The authors Tzung-Dau Wang, Cardiovascular Centre and Division of Cardiology, Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei City, Taiwan, and colleagues, set out to assess the safety and feasibility of balloon angioplasty for isolated penile artery stenoses in patients with erectile dysfunction in this first-in-man study.
“Obstructive pelvic arterial lesions are highly prevalent in patients with erectile dysfunction and commonly located in penile artery segments,” Wang and colleagues write.
The researchers enrolled 25 patients with erectile dysfunction and isolated penile artery stenoses (unilateral stenosis ≥70% or bilateral stenoses ≥50%) as identified by pelvic computed tomographic angiography. From these, 20 patients (mean age 61 years [range, 48-79 years]) underwent balloon angioplasty. Three of these patients had bilateral penile artery stenosis, Wang told delegates.
Wang and colleagues achieved procedural success in all 23 penile arteries, with an average balloon size of 1.6mm (range, 1-2.25mm). The average International Index for Erectile Function-5 (IIEF-5) score improved from 10.0±5.2 at baseline to 15.2±6.7 (p<0.001) at one month and 15.2±6.3 (p<0.001) at six months. Clinical success (change in the IIEF-5 score ≥4 or normalisation of erectile function [IIEF-5 ≥22]) was achieved in 15 (75%), 13 (65%), and 12 (60%) patients at one, three, and six months, respectively. There were no adverse events through follow-up.
An accompanying editorial in EuroIntervention by Jason H Rogers, University of Califorina, Davis Medical Centre, Sacramento, USA, notes: “Erectile dysfunction is a complex, multifactorial psycho-physical condition. For interventionalists, it is tempting to look at an angiographic stenosis in an erectile-related artery in a patient with erectile dysfunction and attribute a cause-effect relationship.”
Rogers also writes that the results of the study from Taiwan had shown “modest” response to intervention as measured by IIEF-5 that could be explained by the placebo effect. “Eighty five per cent of patients at six months still had an IIEF score of <22, which continues to meet the definition for some degree of erectile dysfunction. Longer term clinical follow-up will be required. Without any objective assessment of penile arterial inflow or imaging follow-up, it is not possible to describe what physiologic effect was achieved by performing angioplasty. Given the excitement to find an interventional solution for such a common clinical condition as erectile dysfunction, carefully controlled studies are required,” he writes.