CORONAVIRUS (COVID-19)

Resources on COVID-19 and how BCBSND is responding to help protect all North Dakotans

Percutaneous Intradiscal Electrothermal Annuloplasty, Radiofrequency Annuloplasty, and Biacuplasty

Section: Surgery
Effective Date: July 01, 2018
Revised Date: November 14, 2019

Description

Discogenic Low Back Pain

Discogenic low back pain is a common, multifactorial pain syndrome that involves low back pain without radicular symptoms findings, in conjunction with radiologically confirmed degenerative disc disease.

Treatment

Typical treatment includes conservative therapy with physical therapy and medication management, with potential for surgical decompression in more severe cases.

A number of electrothermal intradiscal procedures have been introduced to treat discogenic low back pain; they rely on various probe designs to introduce radiofrequency (RF) energy into the disc. It has been proposedthat heat-induced denaturation of collagen fibers in the annular lamellae may stabilize the disc and potentially seal annular fissures and that pain reduction may occur through the thermal coagulation of nociceptors in the outer annulus.

Some electrothermal intradiscal procedures are briefly described next.

With the intradiscal electrothermal annuloplasty procedure, a navigable catheter with an embedded thermal resistive coil is inserted posterolaterally into the disc annulus or nucleus. Using indirect RF energy, electrothermal heat is generated within the thermal resistive coil at a temperature of 90°C; the disc material is heated for up to 20 minutes. Proposed advantages of indirect electrothermal delivery of RF energy with intradiscal electrothermal annuloplasty include precise temperature feedback and control, and the ability to provide electrothermocoagulation to a broader tissue segment than would be allowed with a direct RF needle.

Percutaneous intradiscal radiofrequency thermocoagulation uses direct application of RF energy. With percutaneous intradiscal radiofrequency thermocoagulation, the RF probe is placed into the center of the disc, and the device is activated for only 90 seconds at a temperature of 70°C. The procedure is not designed to coagulate, burn, or ablate tissue. The Radionics RF Disc Catheter System has been specifically designed for this purpose.

Intradiscal biacuplasty uses 2 cooled RF electrodes placed on the posterolateral sides of the intervertebral annulus fibrosus. It is believed that, by cooling the probes, a larger area may be treatedthan could occur with a regular needle probe.

Annuloplasty using a laser-assisted spinal endoscopy kit to coagulate the disc granulation tissue (percutaneous endoscopic laser annuloplasty) has also been described.

Regulatory Status

A variety of RF coagulation devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA), some of which are designed for disc nucleotomy. In 2002, the Oratec Nucleotomy Catheter (ORATEC Interventions, Menlo Park, CA, acquired by Smith & Nephew in 2002) was cleared for marketing by FDA through the 510(k) process. The predicate device was the SpineCATH® Intradiscal Catheter, which received FDA clearance for marketing in 1999. The Radionics (a division of Tyco Healthcare group) RF (Radiofrequency) Disc Catheter System received marketing clearance by FDA through the 510(k) process in 2000. FDA product code: GEI.

In 2005, the Baylis Pain Management Cooled Probe was also cleared for marketing by FDA through the 510(k) process. It is intended for use “in conjunction with the Radio Frequency Generator to create radiofrequency lesions in nervous tissue.” FDA product code: GXI.

Note: This evidence review does not address disc nucleoplasty, a technique based on the bipolar RF device (Coblation®; ArthroCare, Austin, TX, acquired by Smith & Nephew, 2014). With the coblation system, a bipolar RF device is used to provide lower energy treatment to the intervertebral disc, which is designed to provide tissue removal with minimal thermal damage to collateral tissue. Disc nucleoplasty is closer in concept to a laser discectomy in that tissue is removed or ablated to provide decompression of a bulging disc. Disc nucleoplasty and laser discectomy are considered in evidence review 7.01.93.

Criteria

Percutaneous annuloplasty (eg, intradiscal electrothermal annuloplasty, intradiscal radiofrequency annuloplasty, or intradiscal biacuplasty) for the treatment of chronic discogenic back pain is considered investigational.

Procedure Codes

22526 22527 72285  72295 62290 62291

Diagnosis Codes

NA

Professional Statements and Societal Positions Guidelines

Practice Guidelines and Position Statements

American Society of Interventional Pain Physicians

A 2013 review of the evidence informing American Society of Interventional Pain Physicians guidelines found limited-to-fair evidence for intradiscal electrothermal therapy (IDET; another term for intradiscal electrothermal annuloplasty) and biacuplasty and limited evidence for percutaneous intradiscal radiofrequency thermocoagulation (PIRFT). These guidelines updated 2007 guidelines, which concluded that the evidence was moderate for management of chronic discogenic low back pain with IDET. Complications included catheter breakage, nerve root injuries, post-IDET disc herniation, cauda equina syndrome, infection, epidural abscess, and spinal cord damage. The evidence for PIRFT was limited, with complications similar to IDET.

National Institute for Health and Care Excellence

A National Institute for Health and Care Excellence (NICE) guidance, updated in 2016, indicated that the evidence on safety and efficacy of PIRFT for low back pain was “limited” and should only be used by “special arrangement”.

The NICE guidance on electrothermal annuloplasty was also updated in 2016. NICE considered evidence on the efficacy of PIRFT for low back pain to be inconsistent and of poor quality, although no major safety concerns were identified. NICE recommended PIRFT only with special arrangements for clinical governance, consent, and audit or research.

Links