Name of the Procedure:

Factor VIIa (antihemophilic factor, recombinant), per 1 microgram (HCPCS Code: J7189)

Summary

Factor VIIa, also known as antihemophilic factor, recombinant, is a synthetic protein used to aid patients with bleeding disorders. Administered via injection, it helps the blood clot in patients who have hemophilia or other conditions that hinder normal blood coagulation.

Purpose

Factor VIIa is primarily used to manage bleeding episodes or to prevent bleeding during surgeries for patients with hemophilia A or B with inhibitors, acquired hemophilia, or congenital factor VII deficiency. The goal is to facilitate normal clotting, thus reducing bleeding and preventing long-term complications.

Indications

• Hemophilia A or B with inhibitors
• Acquired hemophilia
• Congenital factor VII deficiency
• Glanzmann's thrombasthenia (in certain situations) Patients experiencing spontaneous bleeding, trauma, or preparing for surgery may be candidates for this treatment.

Preparation

• No specific fasting or special preparation is generally required.
• Patients should inform their healthcare provider of all medications they are taking.
• Blood tests may be conducted to determine the baseline clotting ability and to tailor the dose precisely.

Procedure Description

1. Assessment: Healthcare providers will assess the patient's condition and determine the appropriate dose.
2. Preparation: The necessary volume of factor VIIa is calculated based on patient weight and severity of the condition.
3. Administration: The recombinant factor VIIa is administered through an intravenous (IV) injection.
4. Monitoring: The patient is monitored for signs of effective clotting and any adverse reactions.

Tools and Equipment:

• IV injection kit
• Syringes and needles
• Factor VIIa medication

Anesthesia or Sedation: Not applicable, as this is a simple IV injection.

Duration

The injection process itself takes a few minutes, although patients may be observed for a short period post-injection to monitor for any immediate reactions.

Setting

The procedure is typically performed in a hospital, outpatient clinic, or infusion center.

Personnel

• Hematologist or specialist physician
• Nurse or medical assistant

Risks and Complications

• Common risks: Localized pain or swelling at the injection site, headache, fever.
• Rare risks: Allergic reactions, thromboembolic events (clots in vessels).
• Management of complications involves close monitoring and ready access to emergency medical care.

Benefits

• Rapid control of bleeding episodes.
• Prevention of bleeding complications during surgeries or invasive procedures.
• Improved quality of life with fewer bleeding crises.

Patients may notice an improvement in bleeding symptoms almost immediately or within a few hours post-administration.

Recovery

• Post-procedure care: Monitor for any signs of adverse reactions.
• Instructions: Patients should avoid strenuous activities and follow any specific advice given by their healthcare provider.
• Recovery time: Usually minimal with no significant downtime. Regular follow-up may be necessary to monitor the effectiveness of the treatment and adjust dosages if needed.

Alternatives

• Plasma-derived clotting factors
• Other recombinant clotting factors
• Bypassing agents (e.g., activated prothrombin complex concentrates) Each alternative has different benefits and risks. For instance, plasma-derived factors may carry a risk of viral transmission, while bypass agents may be less predictable in their efficacy.

Patient Experience

During the procedure, patients might feel a slight sting from the IV needle. After the procedure, they might experience some localized discomfort or transient systemic symptoms like a headache or fever. Pain management includes over-the-counter pain medications if needed, and comfort measures such as ice packs can alleviate injection site discomfort.