Varicocoele embolization with sclerosing agents leads to lower radiation exposure and procedural costs than coils: Data from a real‐life before and after study

Abstract Objectives To investigate clinical outcomes, radiation exposure and procedural costs associated with percutaneous varicocoele embolization using coils and sclerosing agents (SAs) in a cohort of young‐adult men. Materials and methods Data from consecutive men treated with percutaneous varicocoele embolization using coils and SA between 2017 and 2021 were analyzed. The allocation was based on a change of policy occurred in June 2020 with the substitution of coils with SA (before and after study). Semen analysis values were based on 2010 WHO reference criteria. Anatomic variants of gonadal veins were categorized according to Jargiello et al. Intraoperative radiation dose and procedural costs were collected for each patient. Descriptive statistics and linear regression models were used to describe the association between clinical parameters with procedural costs and radiation exposure. Results One hundred sixteen men were included, of whom 76 (65.5%) received coils, and 40 (34.5%) received SA. Baseline characteristics of the two study groups did not differ. A type 3 Jargiello anatomic variation of left gonadal vein was found in 45.7% of cases. Radiation dose was lower in the SA group as compared to the coils one (13.2 [7–43] vs. 19.8 [12–57] Gy/cm2; p < 0.001). Similarly, procedural costs were lower for the SA group (169.6 [169–199] € vs. 642.5 [561–775] €; p < 0.001). At follow‐up, pain and sperm variables significantly improved in both groups (p < 0.01), without differences among the embolic materials. Linear regression model revealed that coils use was associated with higher radiation exposure (beta 8.8, p = 0.02) than SA after accounting for anatomic variation of gonadal vein, body mass index, and vascular access. Conclusions SA and coils for varicocoele embolization are equally safe and effective. The use of SA was associated with lower radiation exposure and procedural costs than coils. These results should be considered in terms of public health cost and patient's safety.


INTRODUCTION
Varicocoele is a common congenital abnormality that may be associated with several andrological conditions, including couple's infertility, reduced testicular volume, testicular pain, and hypogonadism. 1 It is estimated that varicocoele may occur in almost 15% of the general male population and in 40% of men presenting for couple's infertility. 2,3 The exact pathophysiological mechanism underlying the association between varicocoele and male subfertility is still debated, but increased scrotal temperature, hypoxia, and reflux of toxic metabolites causing testicular dysfunction and deoxyribonucleic acid damage are the leading hypotheses. 2 Treatment of varicocoele is indicated in symptomatic patients, in adolescents with ipsilateral reduction of testicular volume and progressive testicular dysfunction and in infertile men with clinical varicocoele, abnormal semen parameters, and healthy female counterpart. 3

Several techniques of varicocoele repair have been
proposed including open surgical, laparoscopic, microsurgical, and percutaneous radiological approaches, all of which are associated with different rates of recurrence and complications. 4,5 In adults and pediatric population, percutaneous embolization of varicocoele has widely spread in clinical practice due to its minimally invasive nature and high success rates (approximately 90%). 6 Coils and sclerosing agents (SAs) are among the most commonly used embolic materials during percutaneous embolization of varicocoele. A recent systematic review analyzed data from 3505 subjects treated with varicocoele embolization using coils, glue, and SA. 7 Authors found a 90% success rate after surgery, which was independent from the embolic material. However, mechanical embolization with coils resulted in slightly higher recurrence rates (8%-11%) in the long term follow-up. 7 Of clinical importance, few studies have investigated procedural costs and radiation exposure associated with different embolic materials during varicocoele treatment. These aspects are critically relevant in terms of public health costs and patient's safety in light of the known negative impact of radiations on reproductive organs. Therefore, in this study we sought to investigate (i) clinical outcomes, (ii) radiation exposure, and (iii) procedural costs associated with varicocoele embolization using coils and SA in a cohort of young adult men.

METHODS
We performed a retrospective analysis of data prospectively collected from young adult patients assessed for varicocoele at a single academic center between January 2017 and March 2021.
All participants were assessed with a thorough medical history.  Radiation exposure during the embolization procedure was assessed by the dose area product (DAP, Gy/cm 2 ). The accounts department of the hospital provided detailed expense costs, which were compared among procedures. In particular, we recorded the cost of interventional and embolic materials.
Data collection followed the principles outlined in the Declaration of Helsinki. Since retrospective, a specific informed consent was not foreseen. However, all patients signed an informed consent form for their data to be used for research purposes. The study was approved by the local ethical committee.

RESULTS
One hundred thirty-five subjects were initially selected. We then excluded those lost to follow-up (n = 3; 2.2%), those treated for bilateral varicocoele (n = 1; 0.7%), those with a normal phlebogram (n = 7; 5.2%), and those who could not be treated because of a technical failure (n = 12; 8.8%). A final cohort of 116 (85.9%) men submitted to leftsided varicocoele embolization was considered for statistical analysis.    (Table 3). Orchialgia relief was reported by 98% of men treated for scrotal pain.
Among the whole cohort, radiation dose increased with increasing complexity of vein anatomy (p < 0.01) and in cases performed by jugular access (p = 0.02) (data not shown).

DISCUSSION
Percutaneous treatment of varicocoele was found to be a safe and effective procedure irrespective of the embolic agent, 7 but an accurate investigation of costs and radiation exposure associated with different embolic materials is currently lacking.
Here we found that SA and coils were equally effective for the treatment of varicocoele in young adult men; however, treatment with SA emerged to be a cheaper procedure than the one with coils and SA was associated with lower radiation exposure than solid embolic material. Taking together, these findings would suggest that varicocoele embolization with SA could be preferable than coils in terms of public health costs and patient's safety from radiation exposure.
Our study was motivated by the substantial lack of research concerning costs and radiation safety during percutaneous varicocoele embolization with different materials. We took the opportunity of a    19 Authors showed that glue procedures had the shortest fluoroscopy time; moreover, DAP was lower in glue than coils group, but no difference was noted between glue and SA, and between coils and SA. 19 In the present study, we showed that radiation dose was lower in varicocoele embolization with SA than coils. Additionally, radiation exposure increased with increasing complexity of vein anatomy and in cases performed by jugular access. This difference in radiation dose is likely related to the shorter embolic time, both performed under fluoroscopic guidance, when using SA compared to coils. Furthermore, jugular access is characterized by higher radiation doses than femoral one because of the longer anatomical passage that includes thoracic organs.
In healthcare management, cost effectiveness is a crucial component in the evaluation of any diagnostic or therapeutic intervention.
Various cost analyses have been reported in urology/radiology setting 22,23 but not for varicocoele embolization. Here, we reported that embolization with SA was associated with reduced procedural costs compared to coils, with no impact on clinical outcomes. Therefore, these findings gain important implications from a clinical and economic standpoint.
The clinical implication of our study is several-fold. First, we conducted the first real-life investigation of varicocoele embolization with SA and coils in terms of clinical outcomes, radiations exposure, and procedural costs in a cohort of young-adult men. Second, we revealed for the first time that procedures with SA were associated with lower radiation exposure than those with coils. Radiation to the gonads is associated with an increased risk of infertility or future malignancy, and young patients may be at highest risk given their long-life expectancy.
Therefore, embolization with SA should be preferred for radiation safety. Lastly, procedures with SA were cheaper than those with coils.
Overall, because of similarity in clinical outcomes, lower radiation exposure, and costs associated with SA, this embolic agent could be advantageous in terms of public health costs and patient's safety.
Our study is not devoid of limitations. First, this was a single centerbased study, raising the possibility of selection biases; thereof, larger studies are needed to externally validate our findings. Second, the retrospective nature of this study limits the generalization of our results.
A randomized controlled trial would have obviously been more informative. In this regard, it must however be underlined that a before and after study design has several advantages, the most relevant being the nonexperimental setting. 24 Lastly, despite not being the primary aim of this investigation, we lack long-term follow-up data to investigate recurrence rates among the two groups.

CONCLUSIONS
This cross-sectional, real-life study showed that varicocoele embolization with SA and coils is a safe and effective procedure with clinical outcomes comparable among the two embolic agents. The use of SA was associated with lower radiation exposure and procedural costs than coils. These results should be considered in terms of public health cost and patient's well-being in light of the known negative impact of radiation on reproductive organs. Further studies are needed to externally confirm these observations.

FUNDING INFORMATION
None.