PARIS – Balloon angioplasty for isolated penile artery stenoses improved erectile dysfunction scores, and the results endured at 12-month follow-ups for 55% of treated men, Dr. Tzung-Dau Wang reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
A 41% restenosis rate was noted, however, on CT angiography of the penile arteries, which was performed routinely at 6-9 months post PCI as part of the PERFECT-2 study. Even among the patients with clinically meaningful improvements in their erectile dysfunction scores, one-third had angiographic restenosis, which doesn’t bode well for long-term outcomes.
“Our findings highlight an unmet need for a more enduring treatment modality for penile artery stenotic disease,” said Dr. Wang of National Taiwan University in Taipei. As most penile arteries are less than 2 mm in diameter, they are too small for interventionalists to take on with anything in their toolbox except for plain old balloon angioplasty (POBA).
Last year, Dr. Wang presented the results of the PERFECT-1 study (EuroIntervention 2014;10:147-56), his first-in-man study of POBA for isolated penile artery stenoses in 20 men with erectile dysfunction. At 6 months’ follow-up, 11 (55%) had at least a 4-point improvement from baseline in the International Index for Erectile Dysfunction-5 (IIED-5) score or normalization of erectile function, defined as an IIED-5 score of at least 22.
At EuroPCR 2015, Dr. Wang presented PERFECT-2, a confirmatory study with 12-month follow-up rather than the 6 months in PERFECT-1, and with mandatory CT angiography to learn what happened to the treated vessels.
The study began with 28 treated patients, but 2 of them were excluded because they declined follow-up CT angiography and 4 others had inadequate-quality imaging, leaving a final population of 22 patients with 34 treated penile artery lesions. Their baseline IIED-5 scores averaged 10.1. Fifteen patients had known CAD. Three-quarters of lesions were located in the common penile artery, the rest in the dorsal penile or cavernosal artery. The average target-vessel diameter was 1.7 mm, with a mean lesion length of 11.1 mm. None of the lesions were calcified.
Twenty of the 22 patients were treated with a 1.5-mm balloon. The degree of stenosis was 77% before treatment and 9.5% after treatment. Flow-limiting dissection occurred in two patients, with the complication being successfully managed by prolonged balloon dilation in both cases. No penile hematomas or any other complications occurred.
Binary restenosis, as defined by at least a 50% diameter stenosis upon CT angiography at 6-9 months, occurred in 14 of 34 treated lesions, or 41%. Many patients, however, had more than one treated lesion, and the per-patient restenosis rate was 59%, or 13 of 22 patients. The mean lesion length at follow-up was 4.3 mm.
Nine of the 10 patients without significant clinical improvement as reflected by their change in IIED-5 scores had angiographic binary restenosis. So did 4 of the 12 patients who did experience meaningful improvement in their erectile dysfunction.
Session cochair Dr. Flavio Ribichini, head of interventional cardiology at the University of Verona (Italy), noted that, back in the 1980s, there was considerable interest in balloon angioplasty as a treatment for erectile dysfunction, but the practice was abandoned mainly due to an unacceptably high restenosis rate. He asked why Dr. Wang thought he was getting better results now with POBA.
Much improved technology, Dr. Wang replied.
He reported having no financial conflicts with regard to this study, which was sponsored by National Taiwan University Hospital.