What are the potential side effects of the VenaSeal (venous closure) procedure?

Side Effects of VenaSeal Closure System

The VenaSeal closure system can cause hypersensitivity reactions in approximately 6% of patients, ranging from mild self-limiting rashes to severe type IV hypersensitivity reactions requiring steroids or vein excision in rare cases. 1

Common Side Effects

Phlebitis-like Reactions

• Phlebitis-like "abnormal skin reaction" occurs in approximately 23.5% of patients 2
• These reactions typically present as:
  • Erythematous rash along the treated vein
  • Local inflammation
  • Tenderness over the treatment area
• Most cases are mild and self-limiting, resolving within 2 weeks 2

Hypersensitivity Reactions

• Occur in 5.8-6.3% of patients 1
• Severity classification:
  • Mild (4.2%): Requires no treatment or over-the-counter medications
  • Moderate (1.3%): Requires steroid treatment
  • Severe (0.3%): Lasts >30 days or requires vein excision 1
• Onset typically occurs 1-23 days after procedure (mean 13 days)
• Duration ranges from 3-28 days (mean 10.8 days) 1

Pain

• Mean numerical pain rating scale 6 hours after procedure: 2.7 2
• Generally less painful than thermal ablation techniques due to elimination of tumescent anesthesia 3

Vascular Complications

Access Site Complications

• Similar to other endovascular procedures:
  • Bleeding at access site
  • Bruising/ecchymosis
  • Potential infection (rare)

Venous Thrombosis

• Deep vein thrombosis (DVT) is exceedingly rare 3
• Saphenofemoral junction thrombosis can occur but is uncommon 4

Comparison to Other Techniques

When comparing VenaSeal to radiofrequency ablation (RFA):

• Similar rates of skin reactions (9.1% vs 7.1%)
• Similar rates of subsequent interventions needed (9.1% vs 9.5%)
• Similar efficacy in vein closure at 12-month follow-up 4

Risk Factors and Prevention

• No clear patient or procedural predictive factors for hypersensitivity reactions have been identified
• Interestingly, patients with more advanced venous disease (CEAP clinical class C4-C6) may have a lower risk of hypersensitivity reactions 1
• Previous VenaSeal treatment does not appear to increase risk for hypersensitivity reactions in subsequent treatments 1

Management of Side Effects

For Mild Reactions

• Reassurance and monitoring
• Over-the-counter anti-inflammatory medications if needed

For Moderate Reactions

• Oral steroids
• Antihistamines

For Severe Reactions

• Prolonged steroid treatment
• In rare cases, surgical excision of the treated vein may be required 5, 6

Important Considerations

• Patients should be informed about the possibility of hypersensitivity reactions before undergoing the procedure
• Patients with known allergies to adhesives or cyanoacrylate should be carefully evaluated before treatment
• The advantage of VenaSeal is the lack of thermal injury risk to surrounding structures (skin, nerves, muscles) 3
• No tumescent anesthesia is required, which can improve patient comfort during the procedure 3

VenaSeal remains an effective treatment option for venous insufficiency with a favorable safety profile compared to other endovenous techniques, but patients should be monitored for potential hypersensitivity reactions, particularly in the first few weeks after treatment.