Data from a new study have found that venous leak embolization yields additional clinical improvement and treatment potential in patients with vasculogenic erectile dysfunction (ED) resistant to phosphodiesterase-5-inhibitors (PDE5i) due to mixed arterio-venous disease. These findings were recently published in the journal CardioVascular and Interventional Radiology (CVIR).
The single-centre observational study was led by Nicolas Diehm (Vascular Institute Central Switzerland, Aarau, Switzerland) et al, who collected data from 26 patients treated at their institution between October 2019 to September 2022. All patients were diagnosed with ED resistant to PDE5i without significant clinical benefit following arterial revascularisation of erection-related arteries.
In their description of the study, Diehm and colleagues write that endovascular therapy of vasculogenic ED has recently made “significant progress”, and while several studies have investigated clinical outcomes following either arterial revascularisation or venous embolization, data on combined arterio-venous diseases are “scarce”.
The study authors outline that the combination of arteriogenic and venogenic ED may be prevalent in a subset of patients. They describe that arteriogenic ED is often caused by atherosclerosis triggered by cardiovascular risk factors leading to narrowing of the erection-related arteries. Venogenic ED, however, is caused by incomplete relaxation of cavernosal smooth muscle cells during arterial inflow and subsequent failure to occlude the penile venous outflow tracts.
Thus, to investigate the potential combination of therapies, Diehm and colleagues performed 807 procedures—663 arterial and 144 venous interventions. Technical success for arterial revascularisation was defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with less than 30% residual diameter reduction. Technical success after venous embolization was defined as complete target vein embolization.
Procedural success was achieved in all patients with no major adverse events at six-month follow-up. The primary feasibility endpoint was defined as an International Index of Erectile Function-6 (IIEF-6) score improvement of ≥4 points at six-week follow-up post intervention, which was achieved in three of the 26 (11.5%) patients following arterial revascularisation only. Following an additional venous embolization performed 458±424 days after the initial arterial procedure, the authors report that the primary feasibility endpoint was reached in 17 of 26 (65.4%) patients.
In addition to the IIEF-6 score, Diehm et al also requested patients complete the global patient impression of improvement (PGI-I) questionnaire six weeks post intervention. This showed that two (8%) patients with mixed arterio-venous ED had improved post arterial revascularisation alone, whereas 24 (92%) patients had no change or experienced deterioration. Following the additional venous embolization, 15 (57.5%) patients had improved, nine (34.6%) experienced no change and two (7.7%) had deteriorated when compared with baseline. In addition, at six weeks follow-up, 18 (69.2%) patients stated that they would undergo the endovascular procedures again.
In their discussion of the results, Diehm and colleagues note that a staged combined treatment approach for mixed-arterio ED was “safe and feasible”, highlighting the clinical improvement rate of 65.4% in patients who initially failed to respond to arterial ED treatment alone. The authors determine that their results show that venous leak embolization has potential to further improve clinical outcomes in patients with severe ED who have not responded to arterial revascularisation.
In their conclusory statement, Diehm et al write that their all-comers feasibility study is limited by the relatively small number of patients enrolled with short follow-up. Further, they state that more stringent exclusion criteria may yield better outcomes in future studies in this area, as, in the current cohort, patients with comorbidities such as diabetes mellitus were not excluded.
