Livedoid Vasculopathy (Investigational Adjunct)

Patient Summary

Is this FDA-cleared for this use?

Not FDA-cleared for livedoid vasculopathy. FDA cleared medicinal leeches only for venous congestion in microsurgical reconstruction (K040187, 2004). Use here is Tier C investigational and is in most patients precluded by concurrent systemic anticoagulation.

What evidence exists?

Tier C (investigational). No controlled trials exist for livedoid vasculopathy. The disease is a thrombo-occlusive disorder of dermal microvessels producing painful purpuric macules, ulcers, and atrophie blanche scars, predominantly on the lower legs, and is strongly associated with thrombophilia (factor V Leiden, prothrombin mutation, antiphospholipid syndrome, hyperhomocysteinemia, MTHFR variants), which must be worked up. Evidence-based care combines antiplatelet therapy, anticoagulation (warfarin, low-molecular-weight heparin, or off-label rivaroxaban), pentoxifylline, hyperbaric oxygen, and intravenous immunoglobulin for refractory disease.

Main risks

• Severe and prolonged bleeding from bite sites, especially if concurrent anticoagulation is not held
• Worsening of ulcer formation if a leech is placed on or adjacent to a vasculopathic lesion
• Non-healing bite wound, since underlying microvascular disease impairs healing
• Local skin infection or Aeromonas infection
• Allergic reaction to leech saliva
• Delay of systemic anticoagulation, hyperbaric oxygen, or IVIG, all of which are evidence-supported
• Compounding of bleeding risk in patients with antiphospholipid syndrome already at thrombosis-bleeding balance

Who should not consider this

• Patients on systemic anticoagulation (warfarin, DOACs, heparin) — this is the great majority of livedoid vasculopathy patients
• Patients with active ulceration at the proposed placement site
• Patients without a completed thrombophilia workup
• Pregnant patients (livedoid vasculopathy is associated with antiphospholipid syndrome)
• Patients with recent thrombotic event
• Patients with severe anemia

What to ask your clinician

• Has my thrombophilia workup been completed, including factor V Leiden, prothrombin mutation, antiphospholipid antibodies, homocysteine, and MTHFR?
• Am I on antiplatelet therapy and anticoagulation, and has the regimen been optimized?
• Has hyperbaric oxygen or IVIG been considered for my refractory disease?
• If I am on anticoagulants, can they be safely held for leech therapy, and what is the hematology plan?
• Where exactly will the leech be placed — confirm it is on intact skin adjacent to, not on, any lesion?
• What is the realistic expected benefit, and what is the risk of compounding bleeding?

When to seek urgent care

• Bleeding from a bite site that soaks through more than one dressing per hour, or any bleeding lasting more than 24 hours
• New ulceration or worsening of an existing ulcer
• Spreading redness, warmth, pus, or red streaks around any bite site or lesion
• Fever above 38.0 C / 100.4 F or chills
• New leg swelling, redness, or tenderness (DVT concern)
• Sudden shortness of breath or chest pain (pulmonary embolism)