Cyanoacrylate embolization (CAE) treatment is a non-thermal treatment modality for incompetent saphenous veins. The procedure is less painful and leads to a faster recovery than conventional thermal treatment, with good medium- to long-term outcomes [1,2]. Per the instructions for use (IFU) of the VenaSeal closure system (Medtronic), a representative CAE product, it has only been approved for treating saphenous veins and not non-saphenous veins [3].

Chronic venous diseases (CVDs) of the lower extremities are benign conditions with non-specific symptoms; many different and variable symptoms exist. CVDs are associated with overdiagnosis and over-treatment issues. Given that other diseases must be ruled out based on the observed symptoms, physicians should consider treating patients classified as Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) clinical class C0 or C1 without hemodynamic insufficiency with caution. Excessive intervention could raise an ethical issue [4-6]. Here, we report a case of ignoring the IFU for the treatment of inferior epigastric veins using CAE within the abdominal wall. The patient provided consent for the publication of this manuscript.

A 29-year-old male presented with abdominal wall rash, itching, swelling, and pain. He reported that these symptoms began 3 days before visiting our clinic. Approximately a week prior to presenting at our clinic, the patient underwent the CAE procedure in the abdominal wall at another institution to address testicular pain. His medical and surgical history were uneventful.

Upon physical examination, an extensive rash in the lower abdominal wall below the umbilicus was observed; the patient complained of severe itching and mild pain (Fig. 1). An ultrasound showed high echogenic material in both the inferior epigastric veins and perivenous edema and inflammation in the surrounding areas (Fig. 2, 3).

Figure 1. Phlebitis-like abnormal reaction was observed with a rash on the abdominal wall.

Figure 2. Cyanoacrylate embolization of the right inferior epigastric veins showing highly echogenic material with posterior acoustic shadowing was observed.

Figure 3. Cyanoacrylate embolization of the left inferior epigastric veins showing highly echogenic material with posterior acoustic shadowing was observed.

The patient had been previously checked by the urology department, where various exams were performed for his testicular pain. The etiology of the pain could not be identified, and he was referred to the orthopedic and neurosurgery clinics to rule out the possibility that the pain was of neuromuscular origin. The patient reported that one clinic recommended the CAE procedure for his legs and abdominal wall for treating testicular pain; the procedure was performed a week before visiting our clinic.

No improvements in testicular pain were observed after the procedure. The skin rash and itching appeared around the abdominal wall 3-4 days after the CAE procedure. Similar findings were identified on the patient’s inner right thigh.

A 5-day course of oral steroids and antihistamines was prescribed for the symptoms, which were deemed as a phlebitis-like abnormal reaction (PLAR) derived from the CAE treatment. When the patient returned to our clinic 5 days later, the symptoms associated with PLAR had resolved. The chief complaint of testicular pain remained unchanged, and the patient was advised to be evaluated at another urology clinic. The patient presented to another urology clinic several days after and was diagnosed with “chronic non-bacterial prostatitis syndrome”; in the meantime, the testicular pain persisted.

In South Korea, the over-treatment of CVD has become an issue [7]. When institutions use the VenaSeal closure system method, which is not covered by national insurance in Korea, they can determine the treatment cost autonomously. As a result, some institutions charge up to $10,000 for treating CEAP C0 or C1 cases. Furthermore, an increasing number of cases are being treated by physicians who are not specialized in vascular surgery but, instead, are specialists in orthopedics, neurosurgery, rehabilitation, or general medicine. These specialists use the VenaSeal closure system with a limited observation period. While some have applied CAE to treat “venous pain” in cases involving non-saphenous veins or sclerotherapy failures, this application lacks systematic research and evidence of long-term efficacy. Moreover, adverse events such as those observed in this case are unethical and unscientific burdens for which the patient must bear full responsibility.

This patient presented with no apparent varicosity in the legs and was in a non-symptomatic C0 state, without any symptoms or pain in the lower limbs. The main complaint was testicular pain; however, the patient had received CAE treatment for the right great saphenous vein and the bilateral inferior epigastric vein, which resulted in a PLAR without any testicular pain relief. Our comprehensive review of existing literature revealed no systematic reports or research findings supporting the use of CAE for treating incompetent saphenous veins or the inferior epigastric vein as a means to alleviate testicular pain.

The severity of this patient’s PLAR was mild, and the condition could be easily and conservatively managed. However, cases in which the complete severe PLAR management took several months have been reported [8-10]. Therefore, CAE treatment for non-saphenous veins not only violates the IFU, but is also malpractice, without scientific evidence, and risks the safety of the patient. To prevent adverse events, an individual surgeon or practitioner would need to improve their capabilities and efforts. The supplying companies should also uphold ethical policies and guidelines when providing the products to non-vascular surgery specialists who have an insufficient understanding of CVD in the absence of a commercial point of view.

Based on this case, we report that post-CAE PLARs can occur not only when administered to the saphenous vein but also when administered to other veins. Furthermore, physicians should strictly adhere to the IFU and refrain from trying any new treatment methods solely based on personal experience.

None.

The author has nothing to disclose.