Clinical and Imaging Outcomes up to 1 Year Following Balloon Angioplasty for Isolated Penile Artery Stenoses in Patients With Erectile Dysfunction: The PERFECT-2 Study

J Endovasc Ther. 2016 Dec;23(6):867-877. doi: 10.1177/1526602816669337. Epub 2016 Sep 14.

Abstract

Purpose: To assess the angiographic and clinical outcomes in patients with erectile dysfunction and isolated penile artery stenoses treated by balloon angioplasty.

Methods: In this prospective study, 22 patients (mean age 61.0±7.6 years, range 50-79) with erectile dysfunction and 34 isolated penile artery stenoses (mean 74.9%±9.1%) were enrolled and underwent balloon angioplasty. The mean International Index for Erectile Function-5 (IIEF-5) score at baseline was 10.3±4.5. The mean lesion length was 11.1±9.0 mm (mean reference vessel diameter 1.7±0.4 mm). The primary endpoint was in-segment restenosis ≥50% by pelvic computed tomography angiography (CTA) at 8 months. The 1-year sustained clinical success (IIEF-5 score ≥22 or a ≥4-point change in the IIEF-5 score and no later decline by ≥4) was the secondary outcome measure.

Results: Procedural success was achieved in 31 (91%) of 34 stenotic lesions; there was 1 flow-limiting dissection and 2 arteries with >30% residual stenosis. At 8 months, 14 of 34 lesions in 13 of 22 patients had CTA-documented binary restenosis. At 1 year, sustained clinical success was achieved in 11 of 22 patients. Of the 9 patients not developing binary restenosis, 8 achieved sustained clinical success.

Conclusion: Our findings establish the safety and efficacy of penile artery angioplasty for patients with erectile dysfunction and isolated penile artery stenoses. They also highlight the unmet need for a more enduring treatment strategy for penile artery stenotic disease.

Keywords: angiography; angioplasty; computed tomography; erectile dysfunction; penile artery; restenosis.

MeSH terms

  • Aged
  • Angioplasty, Balloon* / adverse effects
  • Arteries / diagnostic imaging*
  • Arteries / physiopathology
  • Computed Tomography Angiography*
  • Constriction, Pathologic
  • Humans
  • Impotence, Vasculogenic / diagnosis
  • Impotence, Vasculogenic / etiology*
  • Impotence, Vasculogenic / physiopathology
  • Male
  • Middle Aged
  • Multidetector Computed Tomography*
  • Penile Erection*
  • Penis / blood supply*
  • Peripheral Arterial Disease / complications
  • Peripheral Arterial Disease / diagnostic imaging
  • Peripheral Arterial Disease / physiopathology
  • Peripheral Arterial Disease / therapy*
  • Predictive Value of Tests
  • Prospective Studies
  • Recovery of Function
  • Recurrence
  • Time Factors
  • Treatment Outcome
  • Vascular Patency