The National Institute for Clinical Excellence is examining percutaneous vertebroplasty and will publish guidance on its safety and efficacy to the NHS in England and Wales. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about percutaneous vertebroplasty.

This document has been prepared for public consultation. It summarises the procedure and sets out the provisional recommendation made by the Advisory Committee.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendation in the light of the comments received during consultation.
• The Advisory Committee will then prepare the Final Interventional Procedures Document (FIPD) and submit it to the Institute.
• The FIPD may be used as the basis for the Institute's guidance on the use of the procedure in the NHS in England and Wales.

For further details, see the Interim Guide to the Interventional Procedures Programme, which is available from the Institute's website (www.nice.org.uk/ip).

Closing date for comments: 24 June 2003
Target date for publication of guidance: 24 September 2003

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation

Provisional recommendation

Current evidence of the safety and efficacy of percutaneous vertebroplasty appears adequate to support the use of the procedure, provided that normal arrangements are in place for consent, audit and clinical governance.

The Interventional Procedures Advisory Committee also made several recommendations.

• This procedure should only be undertaken in units with good access to a spinal surgery service, by a specialist multi-disciplinary team which includes an interventional radiologist and a spinal surgeon.
• Training and expertise are required for this procedure. In particular, the cement must be made up properly to reduce the risk of embolism.
• Patient selection is important and the procedure should be limited to patients whose pain is refractory to more conservative treatment.
  

The procedure

Indications

Percutaneous vertebroplasty may be used to provide pain relief for patients with severe painful osteoporosis with loss of height and/or with compression fractures of the vertebral body and also for patients with symptomatic vertebral haemangioma and painful vertebral body tumours (metastasis and myeloma).

Vertebral compression fractures are a common cause of pain and disability. Osteopenia associated with aging or chronic steroid use and metastatic disease are the most common aetiologies of vertebral compression fractures. All patients experience pain, which can be of varied duration. Most patients are treated conservatively with analgesics, bedrest and bracing, but a small percentage is left with persistent pain and limited mobility.

Outline of the procedure

Percutaneous vertebroplasty is the injection of acrylic bone cement into the vertebral body in order to relieve pain and/or stabilise the fractures vertebrae and in some cases, restore vertebral height.

Efficacy

The evidence reviewed indicated some level of pain relief in 58-97% of patients, with an associated reduction in medication usage in 50-91% of patients. One study indicated that 93% of patients had improved mobility and that 100% of patients were satisfied with the procedure and would have it again.

The opinions of the Specialist Advisors were divided about this procedure. Some believed that the procedure was proven to work, with numerous publications proving benefit (one Advisor suggested that it is effective in 70-85% of patients). They believed that the procedure could have a major impact in the future as the incidence of osteoperotic spinal fractures increases in an ageing population. Other Advisors suggested that the procedure is unnecessary, that the fractures will heal of their own accord, and that the procedure causes further fractures at a higher level of the spine.

Safety

Reported complications of this procedure were uncommon. They included damage to neural or other structures by needle misplacement or migration of cement. One study observed cement leakage in up to 27% of patients. However, this event was often without sequelae and required further intervention in only 1% of those in that study.

The Specialist Advisors offered different estimates of risk. Some listed paraplegia as a risk (less than 5%), as well as the potential for nerve root damage and infection. Others believed that the procedure is low risk in experienced hands.