Percutaneous balloon kyphoplasty, radiofrequency kyphoplasty (RFK), and mechanical vertebral augmentation with Kiva are interventional techniques involving the fluoroscopically guided injection of polymethylmethacrylate into a cavity created in the vertebral body with a balloon or mechanical device. These techniques have been investigated as options to provide mechanical support and symptomatic relief in patients with osteoporotic vertebral compression fracture or those with osteolytic lesions of the spine (ie, multiple myeloma, metastatic malignancies).

Criteria

Balloon kyphoplasty or mechanical vertebral augmentation using Kiva may be considered medically necessary for:

• The treatment of symptomatic osteoporotic vertebral compression fractures that have failed to respond to conservative treatment (e.g., analgesics, physical therapy, rest) for at least six (6) weeks, or
• The treatment of severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies

Balloon kyphoplasty or mechanical vertebral augmentation using Kiva are considered investigational for all other indications, including use in acute vertebral fractures due to osteoporosis or trauma.

Radiofrequency kyphoplasty is considered investigational.

Mechanical vertebral augmentation using any other device is considered investigational.

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

Practice Guidelines and Position Statements

American College of Radiology et al

The American College of Radiology (2014) and seven (7) other surgical and radiologic specialty associations published a joint position statement on percutaneous vertebral augmentation. This document stated that percutaneous vertebral augmentation, using vertebroplasty or kyphoplasty and performed in a manner consistent with public standards, is a safe, efficacious, and durable procedure in appropriate individuals with symptomatic osteoporotic and neoplastic fractures. The statement also indicated that these procedures be offered only when nonoperative medical therapy has not provided adequate pain relief, or pain is significantly altering the individual's quality of life.

Society of Interventional Radiology

In a quality improvement guideline on percutaneous vertebroplasty from the Society of Interventional Radiology (2014) vertebral augmentation was recommended for compression fractures refractory to medical therapy. Failure of medical therapy includes the following situations:

1. Individuals who are "rendered nonambulatory as a result of pain from a weakened or fractured vertebral body, pain persisting at a level that prevents ambulation despite 24 hours of analgesic therapy";
   
2. Individuals with "sufficient pain from a weakened or fractured vertebral body that physical therapy is intolerable, pain persisting at that level despite 24 hours of analgesic therapy"; or
3. Individuals with "a weakened or fractured vertebral body, and unacceptable side effects such as excessive sedation, confusion, or constipation as a result of the analgesic therapy necessary to reduce pain to a tolerable level."

American Academy of Orthopaedic Surgeons

The American Academy of Orthopaedic Surgeons (2010) approved clinical guidelines on the treatment of osteoporotic spinal compression fractures, which had a weak recommendation for offering kyphoplasty to individuals who "present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact." The Academy indicated that future evidence could overturn existing evidence and that the quality of the current literature is poor. These recommendations were based on the literature reviewed through September 2009.

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence (2013) issued a guidance that recommended percutaneous vertebroplasty and percutaneous balloon kyphoplasty as treatment options for treating osteoporotic vertebral compression fractures in persons having severe, ongoing pain after a recent unhealed vertebral fracture, despite optimal pain management, and whose pain has been confirmed through physical exam and imaging at the level of the fracture. This guidance did not address balloon kyphoplasty with stenting, because the manufacturer of the stenting system (Synthes) stated there is limited evidence for vertebral body stenting given that the system had only recently become available.

The Institute (2008) issued guidance on the diagnosis and management of adults with metastatic spinal cord compression. It was last reviewed in 2014, and placed on the static list (no major ongoing studies identified, with the next review in five (5) years). The guidance stated that vertebroplasty or kyphoplasty should be considered for individuals who have vertebral metastases, and no evidence of spinal cord compression or spinal instability if they have mechanical pain resistant to conventional pain management and vertebral body collapse. Surgery should only be performed when all appropriate specialists, agree. Despite a relatively small sample base, the Institute concluded the evidence suggests, in a select subset of individuals, that early surgery may be more effective at maintaining mobility than radiotherapy.