Authors' objectives:

This Assessment evaluates the outcomes of radiofrequency ablation plus surveillance versus surveillance alone in the treatment of nondysplastic or low-grade dysplastic Barrett’s esophagus. The key concern is whether radiofrequency ablation reduces the rate of disease progression while producing an acceptable risk of adverse events. The ideal way to investigate this is with randomized, comparative trials of these two approaches with long-term follow-up for disease progression or disease-specific mortality.

Authors' recommendations: The available evidence is insufficient to show that radiofrequency ablation plus surveillance achieves a better net health outcome than surveillance alone among patients with nondysplastic or low-grade dysplastic Barrett’s esophagus. Stricture occurs in up to 6% of patients. Stricture carries difficult to quantify risks of esophageal perforation and death, but these events are likely to have a nonzero probability. If the risk of procedure-related mortality is more than zero, evidence is needed to show that it is offset by a sufficiently large reduction in disease progression. Thus, it cannot be concluded that radiofrequency ablation of nondysplastic or low-grade dysplastic Barrett’s esophagus improves the net health outcome. There is considerable variation in the technique of performing radiofrequency ablation. Both circumferential and focal ablation devices are typically used to treat a patient. It is unclear if circumferential ablation should be used more than once. It is also unclear how many follow-up ablation treatments are needed. Endoscopic mucosal resection may contribute toward any effects ablation may have on disease progression. Based on the available evidence, the Blue Cross and Blue Shield Association Medical Advisory Panel made the following judgments about whether radiofrequency ablation of nondysplastic or low-grade dysplastic Barrett’s esophagus meets the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) criteria. 1. The technology must have final approval from the appropriate governmental regulatory bodies. The HALO system, the only radiofrequency ablation device currently represented by outcome studies, was developed by BÂRRX Medical, Inc. (Sunnyvale, Calif.). It is an automated device that uses radiofrequency energy and consists of two components: an energy generator and an ablation catheter. The generator provides rapid (i.e., less than 1 second) delivery of a predetermined amount of radiofrequency energy to the catheter. Both the HALO90 and HALO360 are inserted into the esophagus with an endoscope, using standard techniques. The HALO90 catheter is plate-based and used for focal ablation of areas of Barrett’s esophagus up to 3 cm. The HALO360 uses a balloon catheter that is sized to fit the individual esophagus, and is inflated to allow for circumferential ablation. The ablation with radiofrequency affects only the most superficial layer of the esophagus (the mucosa), with the intent of leaving the underlying tissues unharmed. The HALO360 received U.S. Food and Drug Administration (FDA) marketing clearance via 510(k) in 2005 and the HALO90 in 2006. The FDA-cleared indications are use in coagulation of bleeding and nonbleeding sites in the gastrointestinal tract, and include the treatment of Barrett’s esophagus. 2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes. The key concern is whether radiofrequency ablation reduces the rate of disease progression while producing an acceptable risk of adverse events. The body of evidence on disease progression is too small and of too short a duration to permit conclusions about the effects of radiofrequency ablation on this outcome among patients with nondysplastic or low-grade dysplastic Barrett’s esophagus. 3. The technology must improve the net health outcome. Stricture occurs in up to 6% of patients. Stricture carries difficult to quantify risks of esophageal perforation and death, but these events are likely to have a nonzero probability. If the risk of procedure-related mortality is more than zero, evidence is needed to show that it is offset by a sufficiently large reduction in disease progression. Without clear evidence of reduced disease progression, it cannot be concluded that radiofrequency ablation of nondysplastic or low-grade dysplastic Barrett’s esophagus achieves beneficial outcomes that outweigh harms. 4. The technology must be as beneficial as any established alternatives. A meta-analysis of 51 studies on surveillance alone provided ample evidence on disease progression. The individual risk of developing esophageal adenocarcinoma is 0.6% per year and the risk of mortality due to esophageal adenocarcinoma is 0.3% per year. Evidence does not support conclusions about the effects of radiofrequency ablation plus surveillance on health outcomes among patients with nondysplastic or low-grade dysplastic Barrett’s esophagus. Therefore, it is unclear whether radiofrequency ablation plus surveillance is as beneficial as surveillance alone. 5. The improvement must be attainable outside the investigational settings. Whether radiofrequency ablation plus surveillance improves health outcomes in any setting has not been established. Based on the above, radiofrequency ablation of nondysplastic or low-grade dysplastic Barrett’s esophagus does not meet the TEC criteria.

Project Status: Completed

URL for project: http://www.bcbs.com/blueresources/tec/vols/25/25_05.pdf

Year Published: 2010

URL for published report: http://www.bcbs.com/blueresources/tec/vols/25/radiofrequency-ablation.html

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: BlueCross BlueShield Association

Contact Address: BlueCross BlueShield Association, Technology Evaluation Center, 225 North Michigan Ave, Chicago, Illinois, USA. Tel: 888 832 4321

Contact Name: tec@bcbsa.com

Contact Email: tec@bcbsa.com

Copyright: BlueCross BlueShield Association (BCBS)