Coverage Policy Manual
Policy #: 2008021
Category: Surgery
Initiated: August 2008
Last Review: July 2018
  Radiofrequency Ablation, Barrett's Esophagus

Description:
The esophagus is normally lined by squamous epithelium. Barrett’s esophagus is a condition in which the normal squamous epithelium is replaced by specialized columnar-type epithelium, known as intestinal metaplasia, in response to irritation and injury caused by gastroesophageal reflux disease (GERD). Barrett’s esophagus occurs in the distal esophagus, may be of any length, may be focal or circumferential, and can be visualized by the endoscopist as being a different color than the background squamous mucosa. Confirmation of Barrett’s esophagus requires biopsy of the columnar epithelium and microscopic identification of intestinal metaplasia.
 
Intestinal metaplasia is a precursor to esophageal adenocarcinoma, and esophageal adenocarcinoma is thought to result from a stepwise accumulation of genetic abnormalities in the specialized epithelium, which results in the phenotypic expression of histologic features of low-grade dysplasia (LGD) to high-grade dysplasia (HGD) to carcinoma. Two large epidemiologic studies published in 2011 reported the risk of progression to cancer in patients with Barrett’s esophagus. One study reported the rate of progression to cancer in more than 8,000 patients with a mean duration of follow-up of 7 years (range 1-20 years) (Bhat, 2011). The de novo progression to cancer from Barrett’s esophagus at one year was 0.13%. The risk of progression was reported as 1.4% per year in patients with low-grade dysplasia and 0.17% per year in patients without dysplasia. This incidence translates into a risk of 10-11 times that of the general population. The other study identified over 11,000 patients with Barrett’s esophagus and, after a median follow-up of 5.2 years, reported that the annual risk of esophageal adenocarcinoma was 0.12% (Hvid-Jensen, 2011). Detection of low-grade dysplasia on index endoscopy was associated with an incidence rate for adenocarcinoma of 5.1 cases per 1,000 person-years, and the incidence rate among patients without dysplasia was 1.0 case per 1,000 person-years. Risk estimates for patients with high-grade dysplasia were slightly higher.
 
The reported risk of progression to cancer in Barrett’s esophagus in older studies was much higher, with an annual incidence of risk of 0.4-0.5% per year, with risk estimated at 30-40 times the general population. It is upon these higher risk estimates that current surveillance recommendations have been based.
 
Management of Barrett’s Esophagus
The current management of Barrett’s esophagus includes treatment of GERD and surveillance endoscopy to detect progression to HGD or adenocarcinoma. The finding of LGD typically warrants only follow-up and surveillance biopsies, whereas the finding of HGD or early-stage adenocarcinoma warrants mucosal ablation or resection (either endoscopic mucosal resection [EMR] or esophagectomy).
 
EMR, either focal or circumferential, provides a histologic specimen for examination and staging (unlike ablative techniques). A study (Ell, 2007) provided long-term results for EMR in 100 consecutive patients with early Barrett’s-associated adenocarcinoma (limited to the mucosa). The 5-year overall survival (OS) was 98% and metachronous lesions were observed in 11% of patients after a mean of 36.7 months. In a recent review by Pech and Ell, the authors state that circumferential EMR of the entire segment of Barrett’s leads to a stricture rate of 50%, and recurrences occur at a rate of up to 11% (Pech, 2009).
 
Mucosal ablation techniques that are available consist of one of several thermal (multipolar electrocoagulation [MPEC], argon plasma coagulation [APC], heater probe, Nd:YAG laser, KTP-YAG laser, diode laser, argon laser, and cryoablation) or nonthermal (5-aminolevulinic acid [5-ALA] and photofrin photodynamic therapy [PDT]) techniques. PDT has been the only therapy shown in a randomized Phase III trial to significantly decrease the risk of carcinoma in Barrett’s esophagus (Overholt, 2005). Two hundred and eight patients with HGD were randomly assigned to PDT and omeprazole versus omeprazole alone. At 24 months’ follow-up, 77% of patients treated with PDT had complete ablation of HGD versus 39% in the control group (p<0.0001) and occurrence of adenocarcinoma within a follow-up time of 3.6 years was 13% in the PDT group versus 20% in the control group (p<0.006) (PDT therapy for Barrett’s esophagus is discussed in a separate policy No. 8.01.06). However, the use of PDT for Barrett’s esophagus with HGD has recently decreased dramatically, due to the fact that is relatively expensive and associated with a high complication rate, including photosensitivity and esophageal stricture formation in up to 30% of patients treated with this method (Pech, 2009).
 
The CryoSpray Ablation™ System (formerly the SprayGenix™ Cryo Ablation System, CSA Medical, Inc.) uses a low-pressure spray for spraying liquid nitrogen through an upper endoscope. Cryotherapy allows for treatment of uneven surfaces; however, disadvantages include the uneven application inherent in spraying the cryogen.
 
Treating HGD or mucosal cancer solely with ablative techniques risks undertreating the approximately 10% of patients who have undetected submucosal cancer, in whom esophagectomy would have been required (Pech, 2009).
 
The HALO System from BÂRRX Medical, Inc. (Sunnyvale, Calif.) uses radiofrequency (RF) energy and consists of 2 components: an energy generator and an ablation catheter. The generator provides rapid (i.e., less than 1 second) delivery of a predetermined amount of RF energy to the catheter. Both the HALO90 and HALO360 are inserted into the esophagus with an endoscope, using standard endoscopic 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.
 
Ablation with RF affects only the most superficial layer of the esophagus (the mucosa), leaving the underlying tissues unharmed. Efficacy measures of the procedure include eradication of intestinal metaplasia without leaving behind microscopic (or “buried”) foci and post-ablation regrowth of the normal squamous epithelium. Reports of the efficacy of the HALO system in ablating Barrett’s esophagus have been as high as 70% (comparable to alternative methods of ablation [e.g., APC and MPEC]), and even higher in some reports. The incidence of leaving behind “buried” foci of intestinal metaplasia has been reported to be 20–44% with APC and 7% with MPEC; reports using the HALO system have been 0% (Ganz, 2008). Another potential advantage to the HALO system is that because it is automated, it eliminates operator-dependent error that may be seen with APC and MPEC.
 
Regulatory Status
In 2005, the HALO360 (now Barrx™ 360 RFA Balloon Catheter) was cleared for marketing by the U.S.
Food and Drug Administration (FDA) through the 510(k) process and, in 2006, the HALO90 (now Barrx™
90 RFA Focal Catheter) received clearance. FDA-labeled indications are for use in coagulation of bleeding and nonbleeding sites in the GI), and include the treatment of BE.9 FDA product code: GEI.
 
In December 2007, the CryoSpray Ablation™ System was cleared for marketing by FDA through the 510(k) process for use as a “cryosurgical tool for destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.”10 FDA product code: GEH.
 
In July 2002, the Polar Wand® device (Chek Med Systems, Willington, CT), a cryosurgical device that uses compressed carbon dioxide, was cleared for marketing by FDA through the 510(k) process.
Indications for use are, “ablation of unwanted tissue in the fields of dermatology, gynecology, general surgery, urology, and gastroenterology.”
 
Coding
There is no CPT code specific to radiofrequency or cryoablation of tissue in the esophagus. These procedures would likely be coded using one of the following CPT codes:
 
43229: Esophagoscopy, flexible, transoral; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when performed)
 
43270: Esophagogastroduodenoscopy, flexible, transoral; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when performed)
 
Coding Prior to January 2016
There is no specific CPT code for radiofrequency ablation of Barrett’s esophagus.  CPT codes 43228 and 43258 are codes for endoscopic ablation of tumor(s), polyp(s) or other lesion(s) and should be used for this procedure depending on whether only esophagoscopy is done or whether a full esophago-gastro-duodenoscopy is performed.   .The procedure could be billed with CPT code 43499-unlisted procedure, esophagus; however, either CPT 43228 or 43258 are more specific.

Policy/
Coverage:
Effective July 2014
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Radiofrequency ablation of high grade Barrett’s esophagus meets member benefit certificate primary coverage criteria for effectiveness when confirmed by an expert in gastrointestinal pathology prior to the ablation.
 
Radiofrequency ablation of low grade Barrett’s esophagus meets member benefit certificate primary coverage criteria when confirmed by an expert in gastrointestinal pathology prior to the ablation.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of radiofrequency ablation as a treatment for Barrett’s esophagus in the absence of dysplasia does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For contracts that do not contain member benefit certificate primary coverage criteria the use of radiofrequency ablation as a treatment for Barrett’s esophagus in the absence of dysplasia is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective August 2009 through June 2014
Radiofrequency ablation of high grade Barrett’s esophagus meets member benefit certificate Primary Coverage Criteria for effectiveness based on results from a randomized, single-blind (subject), active control, crossover assignment efficacy study.  The effectiveness of this treatment beyond one year is unknown.
 
Radiofrequency ablation of low grade Barrett’s esophagus does not meet member benefit certificate criteria for effectiveness based on results from the same trial.
 
For contracts that do not contain member Primary Coverage Criteria the use of radiofrequency as a treatment for Barrett’s esophagus without high-grade dysplasia is considered investigational.  Investigational services are an exclusion in the member benefit certificate.
 
Effective, August 2008
Radiofrequency ablation of high grade or low grade dysplasia associated with Barrett's esophagus does not meet member benefit certificate Primary Coverage Criteria for effectiveness, as this treatment is under study in clinical trials to determine effectiveness.
 
For members with certificates of benefit that do not contain Primary Coverage Criteria, radiofrequency ablation of high grade or low grade dysplasia associated with Barrett's esophagus is considered investigational.

Rationale:
This policy was developed due to a June 2008 request for the procedure.
 
Gastroenterologists and surgeons have been interested in developing treatment of high grade dysplasia associated with Barrett's esophagus that is more effective than treatment with proton pump inhibitors, less invasive with lower morbidity and mortality than surgical esophagectomy, and does not require surveilllance with repeaet endoscopy every 2 years.  Photodynamic therapy following intravenous injection of porfimer sodium (Photofrin), a photosensitizer activated by endoscopically applied laser light, was shown to be effective in treating high grade dysplasia associated with Barrett's esophagus in a randomized trial (Overhot, 2005), but side effects, including esophageal stricture and concern for development of skin cancers due to sensitivity to the sun, has lessened enthusiasm for this procedure.  An alternative photosensitizer, 5-aminolevulinic acid, has also been found to be effective, and has a shorter skin photosensitivity period, a lower stricture rate, and is administered orally (Dunn, 2008).
 
A number of uncontrolled studies of radiofrequency ablation of dysplasia associated with Barrett's esophagus appeared following the 2006 FDA approval for marketing.  Modiano and Gerson (2007) describe radiofrequency ablation as a modality being explored for the treatment of Barrett's esophagus.  They do not believe the use of this ablative technology is appropriate until data exists that demonstrates this technique is capable of ablating Barrett's mucosa while minimizing the risk of hidden subsquamous metaplasia and of complications such as strictures.
 
Li et al. (2008) review the treatment for Barrett's esophagus and concluded that pharmacological therapy, antireflux surgery, and endoscopic ablative techniques are promising but studies to date have not had adequate power to assess the effect of treatment on reducing and preventing progression to carcinoma.  This article looked at older endoscopic ablative techniques that did not include circumferential radiofrequency ablation.
 
Fleischer et al (2008) reported results of an uncontrolled trial involving 70 subjects in 8 centers with intestinal metaplasia (IM).  Patients with dysplasia were excluded.  At 12 months 48 of 69 available patients had complete remission of IM.  At 30 months, after additional focal ablative therapy complete remission of IM was achieved in 60 of 61 available patients.  In discussion the authors stated it is premature to advocate ablation for every patient with nondysplastic IM outside of a clinical trial or patient registry protocol.  They express hope that if BE can be eliminated the risk of developing dysplasia or cancer will be reduced or eliminated but as of now there is no proof for this hypothesis.
 
In a 2008 practice guideline (Wang, 2008) for Barrett's esophagus the ACG states further evaluation of the most recent technology for treatment, radiofrequency ablation (RFA), is awaited.
 
2009 Update
Shaheen et al (Shaheen, 2009), in an industry-supported study, reported on 127 patients with BE and low- or high-grade dysplasia treated with RFA using the BARRX Medical Halo® device vs. a sham procedure.  Patients could have up to 4 ablation procedures (initially with a circumferential RFA device and then with focal ablation for residual disease) and underwent periodic biopsies, the final biopsy being at 12 months.  Among patients with low-grade dysplasia (LGD), eradication of dysplasia occurred in 90% of the treated and in 23% of the control patients.  Among patients with high-grade dysplasia (HGD), eradication occurred in 81% of the ablation group and 19% of those in the control group.  Patients in the ablation group had less disease progression (3.6% v. 16%).  Fewer cancers developed in the treated group, although the numbers were so small as to be of borderline significance.  A limitation of the study is that the longest follow-up was at one year; since patients in the control group were offered ablation at one year, it is unlikely that long-term follow-up data will emerge from this study.  Another limitation is the approximate 20% rate of histological eradication of dysplasia in the sham-treated group; this is probably a result of the intrinsic sampling error of esophageal biopsy.  Finally, radiofrequency ablation was not compared with other treatment options.  An accompanying editorial (Bergman, 2009) supports use of RFA for BE with dysplasia but opines that further data is needed before we extend use to those patients who have BE without dysplasia.  At this point, RFA seems an attractive alternative to esophagectomy, with its attendant morbidity and mortality, in patients with BE and HGD.  For patients with BE and LGD, the data are inadequate to support the coverage of RFA until more data accrue on the natural history of LGD.
 
2011 Update
A 2010 TEC Assessment on the use of RFA plus surveillance versus surveillance alone in the treatment of nondysplastic and low-grade dysplastic Barrett’s esophagus included the Shaheen randomized trial and 4 single-arm studies. Studies were selected for inclusion if they were full-length, peer-reviewed articles in English, and studied Barrett’s esophagus treated with RFA in a comparative study of any size, or a single-arm study of at least 40 patients. The conclusions of the Assessment were that among patients with nondysplastic or low-grade dysplastic Barrett’s esophagus:
 
    • The available evidence is insufficient to show that RFA plus surveillance achieves a better net health outcome than surveillance alone.
    • The body of evidence on disease progression is too small and of too short duration to permit conclusions about the effects of RFA on this outcome.
    • There is considerable variation in the technique of performing RFA, and it is unclear whether circumferential ablation should be used more than once, it is unclear how many follow-up RFA treatments are needed, and to what degree endoscopic mucosal resection may contribute toward any effects RFA may have on disease progression.
 
Fleischer and colleagues reported the 5-year follow-up of a previously published study of patients with Barrett’s esophagus without dysplasia (Fleischer, 2010). The original study included 70 patients who underwent circumferential RFA, and complete-response-intestinal metaplasia (CR-IM), defined as complete eradication of nondysplastic Barrett’s esophagus, was seen in 70% of patients at 1-year follow-up; patients with persistent Barrett’s esophagus underwent focal RFA. At the 2.5 year follow-up (Fleischer, 2008), CR-IM was found in 60 of 61 patients (98%). At 5 years’ follow-up, four-quadrant biopsies were obtained from every 1 cm of the original extent of Barrett’s esophagus, and the authors reported the proportion of patients demonstrating CR-IM. If nondysplastic Barrett’s esophagus was identified at the 5-year follow-up, focal RFA was performed one month later and rebiopsy 2 months after to assess histologic response. Primary outcomes were the proportion of patients demonstrating CR-IM at 5-year biopsy or after single session focal RFA. For the 5-year follow-up there were 60 eligible patients, of whom 50 (83%) were willing to participate. Forty-six of fifty patients (92%) showed CR-IM at the 5-year biopsy visit. The four patients found to have Barrett’s esophagus at 5 years underwent a single session of RFA 1 month after biopsy and all were found to have CR-IM at subsequent rebiopsy 2 months after RFA. No strictures were noted. The authors concluded that this first report of 5-year CR-IM outcomes lends support to the safety, efficacy, cost-utility and reduction in neoplastic progression in treating nondysplastic Barrett’s esophagus with RFA.
 
Semlitsch and colleagues reported a systematic review of the evidence for RFA of Barrett’s esophagus based on a total of 9 observational studies and 429 patients (Semlitsch, 2010). (Their review included a literature search up to May 2009 and therefore did not include the Shaheen randomized controlled trial [Shaheen, 2009] which was published end of May 2009). Inclusion criteria for the systematic review required that studies include patients with Barrett’s esophagus and metaplasia or dysplasia for which RFA was the intervention (with or without endoscopic mucosal resection) and have a minimum follow-up period of 12 months. In 7 of the studies, the patients were treated with circumferential ablation followed by focal ablation, whereas 2 studies used only the circumferential method. The maximum number of ablations performed was reported in 7 studies, and ranged from 2 to 5. Complete eradication of Barrett’s esophagus with dysplasia and metaplasia was achieved in 71-100% and 46-100% of patients, respectively. Six cases of esophageal stenosis and one case of buried intestinal metaplasia were reported among all patients.
 
National Comprehensive Cancer Network Guidelines
The 2010 National Comprehensive Cancer Network clinical practice guidelines for esophageal cancer state that esophageal cancer stage Tis (carcinoma in situ) or T1a (intramucosal invasion) may be treated primarily with endoscopic mucosal resection or esophagectomy. The guidelines state that the preferred treatment of Barrett’s esophagus with high-grade dysplasia is surgical resection, but that alternative strategies may include mucosal ablation; radiofrequency ablation is not specifically addressed and the guidelines state that among the methods of mucosal ablation, photodynamic therapy is superior for achieving ablation of metaplastic and dysplastic epithelium as well as for obviating the need for further interventions.  
 
2010 National Cancer Institute Clinical Trials Database (PDQ®)
A search (November 2010) of the U.S. National Institutes of Health ClinicalTrials.gov registry identified a Phase II/III, prospective, observational trial currently recruiting participants with Barrett’s esophagus and gastroesophageal reflux disease. The aim of the study is to evaluate the long-term efficacy of evidence-based diagnostic and therapeutic algorithms and techniques (such as radiofrequency). Estimated enrollment is 100 patients, with an estimated study completion date of August 2017 (NCT00513331).
 
Summary
Radiofrequency ablation of high-grade dysplasia in Barrett’s esophagus has been shown to be at least as effective in eradicating high-grade dysplasia as other ablative techniques with a lower progression rate to cancer, and may be considered as an alternative to esophagectomy.
 
More data are required concerning the use of RFA for the eradication of low-grade dysplasia and nondysplastic Barrett’s esophagus. Longer follow-up is needed to show that eradication will persist, and that the benefits will outweigh potential complications in these patients who show a lower rate of progression to adenocarcinoma than those with high-grade dysplasia.
 
 
2012 Update
A 2010 TEC Assessment on the use of RFA plus surveillance versus surveillance alone in the treatment of nondysplastic and low-grade dysplastic Barrett’s esophagus included the Shaheen et al. randomized trial and 4 single-arm studies (Johnston, 2005).   Additional studies were selected for inclusion if they were full-length, peer-reviewed articles in English, and studied Barrett’s esophagus treated with RFA in a comparative study of any size, or a single-arm study of at least 40 patients. The conclusions of the Assessment were that among patients with nondysplastic or low-grade dysplastic Barrett’s esophagus:
 
  • The available evidence is insufficient to show that RFA plus surveillance achieves a better net health outcome than surveillance alone.
  • The body of evidence on disease progression is too small and of too short duration to permit conclusions about the effects of RFA on this outcome.
 
In addition, the TEC Assessment discussed challenges in diagnostic differentiation between non-dysplastic Barrett’s esophagus and Barrett’s esophagus with low-grade dysplasia (Dumot, 2009) (Greenwald, 2010).  Both sampling bias and interobserver variability have been shown to be problematic. Therefore, analysis of progression to carcinoma in Barrett’s with intestinal metaplasia versus low-grade dysplasia is a challenge. Initial diagnosis of Barrett’s esophagus can be a challenge with respect to histologic grading because inflammation and low-grade dysplasia can share similar histologic characteristics (Shaheen, 2010).
 
In the Shaheen RCT, there were 64 patients with LGD. At 12 months follow-up, the dysplasia was completely eradicated in 90.5% of those in the RFA group, compared with 22.7% of those in the control group (p<0.001). There were no patients in the LGD group that progressed to cancer over the initial 12 months. Progression to HGD was noted in 2/42 (5%) of patients in the RFA group, compared to 3/22 (14%) in the control group. The difference in rates of progression to HGD did not reach statistical significance (RR: 0.3, 95% CI: 0.1-1.9, p=0.33).
 
After 2 years, there were 52 subjects available who had initial LGD treated with RFA. Progression from LGD to HGD or cancer occurred in one patient, for an estimated rate of 2.0% per patient per year. In patients with initial LGD, all dysplasia was eradicated in 51 of 52 (98%), and all intestinal metaplasia was eradicated in 51 of 52 (98%).
 
Further risk stratification of patients with LGD has been an active area of research, given the variable progression rates reported in the literature and the uncertain risk/benefit ratio of RFA when rates of progression are low. Attempts to define clinical and/or demographic factors, such as age, lesion size, or multifocal lesions, which predict progression, have been attempted. Although these factors have been found to be predictors of progression in some studies, it has not been possible to define an optimal cutoff for these factors that offers good discrimination between progressors and non-progressors (Bhat, 2011).
 
Bhat and colleagues followed 8522 patients with Barrett’s esophagus (Bhatt, 2011).  After a mean of 7 years of follow-up, 79 patients were diagnosed with esophageal cancer, 16 with cancer of the gastric cardia and 36 with high-grade dysplasia. Incidence of esophageal or gastric cancer or high-grade dysplasia combined was only 0.22% per year. The authors suggest, “currently recommended surveillance strategies may not be cost-effective” (Bhat, 2011). In an accompanying editorial, the author points out, “Key avenues for future investigation include the determination of whether surveillance or treatment (eg, ablation or chemoprevention) actually decrease cancer deaths and the development of better techniques for risk stratification” (Corley, 2011).
 
Another line of research to risk-stratify patients with low-grade dysplasia has been to use multiple pathologists, including experts in gastrointestinal (GI) histopathology, to confirm the initial diagnosis of LGD. There is a high degree of intraobserver variability in pathologists’ reading of low-grade dysplasia (LGD) versus inflammatory changes, and this variability in pathology diagnosis may contribute to the variable rates of progression of LGD reported in the literature (BCBSA TEC, 2010).  Kerkhof et al. (Kerkhof, 2012) reported that in patients with an initial pathological diagnosis of LGD, review by an expert pathologists will result in downgrading the initial diagnosis to non-dysplasia in up to 50% of cases. Curvers et al. tested this hypothesis in 147 patients with BE who were given an initial diagnosis of LGD (Curvers, 2010). All pathology slides were then read by 2 expert GI pathologists with extensive experience in BE, with disagreements among experts resolved by consensus. After review by expert pathologists, 85% of initial diagnoses of LGD were downgraded to non-dysplasia, leaving a total of only 22/147 patients (15%) with a confirmed diagnosis of LGD. All patients were followed for a mean of 5.1 years for progression to HGD or cancer. For patients with confirmed LGD, the rate of progression was 13.4%, compared with a rate of 0.5% for patients who had been downgraded to non-dysplasia.
 
The risk of progression from LGD to cancer is not well-defined, with highly variable rates reported in the published literature. Evidence from randomized and non-randomized studies establishes that RFA can achieve complete eradication of dysplasia in patients with LGD that is durable for at least 2 years. However, in the single RCT there were only a limited number of patients that progressed from LGD to HGD, and there was not a significant reduction in progression for patients treated with RFA. As a result the risk/benefit ratio of treating all patients with an initial diagnosis of LGD is uncertain. The coverage statement is unchanged.
 
2013 Update
A literature search was conducted through June 2013. There was no new information identified that would prompt a change in the coverage statement.
 
2014 Update
RFA versus surgical resection for Barrett esophagus
In 2014 Chadwick et al reported on a systematic review which compared RFA and complete endoscopic resection (ER) for Barrett esophagus (BE) (Chadwick, 2014). Twenty studies (22 articles) were reviewed including 2 randomized controlled trials (RCT), 10 cohort studies on ER and 8 cohort studies on RFA. The only study that compared RFA and ER was the RCT by van Vilsteren (described next) (van Vilsteren, 2011). The other RCT was by Shaheen et al (also described next) (Shaheen, 2009; Shaheen, 2011). The studies were heterogeneous in design. A total of 1087 (532 ER, 555 RFA) patients with high-grade dysplasia (HGD) or intramucosal cancer were included in the studies reviewed. The median number of resections or RFA sessions required for BE eradication was 2. Complete ER and RFA eradicated BE dysplasia in 95% and 92%, respectively. Eradication was maintained in 95% of ER patients at a median follow-up of 23 months and in 94% of RFA patients at a median follow-up of 21 months. Fewer RFA patients experienced short-term adverse effects (2.5%) versus complete ER (12%). Esophageal strictures requiring additional treatment occurred in 4% of RFA patients and 38% of complete ER patients.
 
In 2013 Orman et al reported on a systematic review and meta-analysis of 24 studies with a total of 4342 patients treated with RFA for BE dysplasia and intestinal metaplasia (Orman, 2013).  Included in the review were the van Vilsteren and Shaheen studies (van Vilsteren, 2011; Shaheen, 2009; Shaheen, 2011). The studies were heterogeneous in design and contained a mix of nondysplastic and LGD and HGD. The use of ER varied in the studies with a range of 0% to 96%. Patients were followed for a median of 20.5 months (range, 12-31 months). For patients treated with RFA, complete eradication of dysplasia occurred in 91% (95% confidence interval [CI], 87% to 95%), and complete eradication of intestinal metaplasia occurred in 78% (95% CI, 70% to 86%). Intestinal metaplasia recurred in 13% (95% CI, 9% to 18%) after eradication. In patients with complete eradication of intestinal metaplasia, 0.2% and 0.7% progressed to cancer during treatment and after treatment, respectively. The most frequent adverse even was esophageal stricture, which occurred in 5% of patients (95% CI, 3% to 7%).
 
Low-grade dysplasia
In 2014, Phoa and colleagues reported results of a randomized controlled trial of RFA versus surveillance in patients with LGD (Phoa, 2014). This trial randomized 140 patients with BE and confirmed LGD; four patients were excluded after randomization due to not meeting study inclusion criteria at further review, leaving a total of 136 patients in the modified intention-to-treat analysis. “Confirmed” LGD was defined as a diagnosis of LGD by the local pathologist with confirmation by a centralized expert panel of pathologists convened for the trial. The primary outcome measure was the occurrence of either high-grade dysplasia or adenocarcinoma up to 3 years following randomization. Secondary outcomes were complete eradication of dysplasia, the absence of intestinal metaplasia, and adverse events.
 
The study was terminated early due to interim analysis that determined superiority of RFA. At the time of termination all patients had reached the 24 month follow-up time point, and the median follow-up was 36 months. The occurrence of adenocarcinoma was significantly lower in the RFA group (1.5%) compared to the surveillance group (8.8%, p<0.03), and the occurrence of high-grade dysplasia was also significantly lower for the RFA group (1.5%) compared to the surveillance group (26.5%, p<0.001). For patients treated with RFA, complete eradication of dysplasia during follow-up was 98.4% and the absence of metaplasia was 90.0%. There were three serious adverse events in 2 patients who received RFA (1 abdominal pain requiring hospitalization, 1 bleeding episode, 1 episode of fever/chills following dilation for stricture), and a total of 12 other adverse events (8 strictures requiring dilation, 3 mucosal lacerations, 1 retrosternal pain).
 
For patients with low-grade dysplasia (LGD), 1 RCT has reported that RFA reduces progression to high-grade dysplasia and adenocarcinoma in patients with confirmed LGD. Based on the results of this RCT, other available evidence, specialty society guidelines, and the results of clinical vetting, it is possible to define a population with a higher risk of progression by having the initial LGD diagnosis confirmed by an additional pathologist who is an expert in gastrointestinal (GI) pathology. In this subpopulation of patients with an initial diagnosis of LGD, the benefit of treatment outweighs the risk. As a result, the coverage statement has been revised to allow coverage of RFA of LGD for patients with LGD when the initial diagnosis of LGD is confirmed by an expert in GI pathology.
 
RFA for Nondysplastic BE.
There are no RCTs that evaluate treatment of nondysplastic BE with RFA. The evidence on this question consists of single-arm trials that report outcomes of RFA. This evidence can provide useful data on the success in eradicating dysplasia, but cannot provide high-quality evidence on the comparative efficacy of RFA versus surveillance alone. Progression to cancer in nondysplastic BE is lower than that for LGD or HGD, with rates in the literature ranging from 0.05% to 0.5% (Bhatt, 2011; Hvid-Jensoen, 2011).
 
Fleischer et al reported the 5-year follow-up of a single-arm study of patients with nondysplastic BE treated with RFA (Fleischer, 2010; Fleischer, 2008). The original study included 70 patients who underwent circumferential RFA(28) and CR-IM; defined as complete eradication of nondysplastic BE, CR-IM was seen in 70% of patients at 1-year follow-up; patients with persistent BE underwent focal RFA. At the 2.5-year follow-up (Fleischer, 2008) CR-IM was found in 60 of 61 patients (98%). At 5-year follow-up, 4-quadrant biopsies were obtained from every 1 cm of the original extent of BE, and the authors reported the proportion of patients demonstrating CR-IM (Fleischer, 2010).  If nondysplastic BE was identified at the 5-year follow-up, focal RFA was performed 1 month later and re-biopsy 2 months after to assess histologic response. Primary outcomes were the proportion of patients demonstrating CR-IM at 5-year biopsy or after single session focal RFA. For the 5-year follow-up, there were 60 eligible patients, 50 (83%) of whom were willing to participate. Forty-six of 50 patients (92%) showed CR-IM at the 5-year biopsy visit. The 4 patients found to have BE at 5 years underwent a single session of RFA 1 month after biopsy, and all were found to have CR-IM at subsequent rebiopsy 2 months after RFA. No strictures were noted. The authors concluded that this first report of 5-year CR-IM outcomes lends support to the safety, efficacy, cost-utility, and reduction in neoplastic progression in treating nondysplastic BE with RFA.
 
Nondysplastic BE has a relatively low rate of progression to cancer. Although available research reports that nondysplastic metaplasia can be eradicated by RFA, the risk/benefit ratio and the net effect on health outcomes is uncertain. It is possible that the risk of RFA exceeds the benefit in this population, owing to the low underlying rates of progression and the reported rates of esophageal strictures following RFA.
    
2016 Update
A literature search conducted through April 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
David and colleagues compared several endovascular therapies, including RFA, RFA and endoscopic mucosal resection, and PDT, among patients with BE with HGD or adenocarcinoma (David, 2015). Of the 342 patients included, 98 underwent endoscopic mucosal resection plus RFA, 119 RFA alone, and 125 PDT. Patients treated with PDT were typically older and had more advanced stages of Barrett’s disease and more co- morbidities. In multivariable analysis, complete remission of intestinal metaplasia was more likely in PDT patients than those treated with endoscopic mucosal resection with RFA (RR 2.69, P<0.001) or with RFA alone (RR 4.47, P<0.001). However, the multivariable analysis did not adjust for a history of esophageal cancer, esophagectomy, or warfarin use. Among 121 patients who had at least 1 follow-up after complete remission of intestinal metaplasia was established, the disease recurrence rate was 32.2%, which did not differ across treatment groups.
 
In 2015, Canto and colleagues reported on a retrospective, single-center study evaluated a carbon dioxide cryosurgery device for treatment of with neoplasia or HGD who were treatment-naïve or who had persistent or recurrent neoplasia after initial treatment (Canto, 2015). The study’s analysis included 68 patients who were offered treatment with cryoablation for either initial therapy (n=21) or after previous therapy with any ablative technique (n=47). At 1 year, complete response for dysplasia was 89% (57/64) overall and 95% (19/20) and 86% (38/44) in treatment-naïve and previously treated patients, respectively. Over a median follow-up of 4.2 years, the complete response for HGD at 3 years or study end was not statistically significantly different between treatment-naïve and previously treated patients (100% for treatment-naïveand 84% for previously treated; P=0.08).
 
Also in 2015, Sengupta and colleagues evaluated cryoablation among 16 patients who failed RFA in a retrospective, single-center study (Sengupta, 2015). The cohort of 16 patients was derived from an original cohort of 121 patients who underwent RFA for BE with LGD, HCD, or IMC. After a median 3 RFA treatments, 91 subjects had complete eradication of dysplasia. Of 21 patients offered cryotherapy, 16 underwent cryotherapy and had adequate follow-up. Fourteen of those who did not have complete eradication and 2 patients who had recurrence of dysplasia underwent salvage cryotherapy. Over a median follow-up of 2.5 months, and with a median 3 cryotherapy treatments, 12 patients (75%) had complete eradication of dysplasia after cryotherapy and 14 (88%) had some improvement in pathology after cryotherapy.
 
There are no controlled trials evaluating the treatment of BE. The evidence from uncontrolled studies report high rates of success in eradicating dysplasia, with low rates of complications. These data are not sufficient to determine the comparative efficacy of cryoablation compared with RFA.
 
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed below:
 
Ongoing:
(NCT01961778) Prospective Randomized Trial Comparing Radiofrequency Ablation (Barrx™) and Cryotherapy (truFreeze™) for the Treatment of Barrett's Esophagus With High-Grade Dysplasia and/or Early Adenocarcinoma; planned enrollment 50; completion date February 2016.
 
(NCT01572987) Endoscopic Resection or Ablation for Patients With Dysplasia or Intramucosal Cancer in Barrett's Esophagus (ERADICATE); planned enrollment 82; completion date June 2018.
 
(NCT02558504) Clinical and Medico-economic Evaluation of Radiofrequency Ablation Versus Oesophagectomy in the Treatment of High Grade Dysplasia in Barrett's Oesophagus; planned enrollment 250; completion date November 2018.
 
The evidence for the use of endoscopic radiofrequency ablation (RFA) for the treatment of individuals with Barrett esophagus (BE) with high grade dysplasia (HGD) includes 1 RCT comparing radical endoscopic resection with focal endoscopic resection followed by RFA, 1 RCT comparing RFA with surveillance alone, and a number of observational studies, some of which compared RFA with other endoscopic treatment modalities. Relevant outcomes include overall survival, change in disease status, morbid events, and treatment-related morbidity and mortality. The available evidence indicates that RFA of high-grade dysplasia (HGD) in BE has been shown to be at least as effective in eradicating HGD as other ablative techniques with a lower progression rate to cancer and may be considered as an alternative to esophagectomy. Evidence from at least 1 RCT demonstrates higher rates of eradication than surveillance alone. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.
 
The evidence for the use of endoscopic RFA for the treatment of individuals with BE with low grade dysplasia (LGD) includes at least 2 RCTs comparing RFA with surveillance alone, a number of observational studies, and systematic reviews of these studies. Relevant outcomes include overall survival, change in disease status, morbid events, and treatment-related morbidity and mortality. For patients with low-grade dysplasia (LGD), evidence from 1 RCT that RFA reduces progression to HGD and adenocarcinoma in patients with confirmed LGD. There are challenges in diagnostic differentiation between nondysplastic BE and BE with LGD that are important in the consideration of treatment for LGD. One of the available RCTs required confirmation of LGD by an expert panel, which supports the use of confirmation of LGD by a gastrointestinal pathologist before treatment of BE with LGD. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.
 
The evidence for the use of RFA for the treatment of patients with BE without dysplasia include single-arm studies reporting outcomes after RFA. Relevant outcomes include overall survival, change in disease status, morbid events, and treatment-related morbidity and mortality. The available studies suggest that nondysplastic metaplasia can be eradicated by RFA. However, the risk/benefit ratio and the net effect of RFA on health outcomes are unknown. The evidence is insufficient to determine the effects of the technology on health outcomes.
 
The evidence for the use of cryoablation for BE (with or without dysplasia) includes non-comparative studies reporting outcomes after cryoablation. Relevant outcomes include overall survival, change in disease status, morbid events, and treatment-related morbidity and mortality. These studies generally demonstrate high rates of eradication of dysplasia. However, the available evidence does not allow comparisons with surgical care or RFA. The evidence is insufficient to determine the effects of the technology on health outcomes.
 
July 2017
A literature search conducted using the MEDLINE database through June 2017 did not reveal any new literature that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2016, Phoa et al reported on a prospective, single-arm interventional study with 132 subjects that evaluated the use of combined EMR with RFA for BE with HGD and/or early cancer (Phoa, 2016). At baseline endoscopy, all visible abnormalities were removed at a single endoscopic resection for histologic staging. After 2 mapping endoscopies, patients underwent the first RFA treatment for circumferential or focal ablation, after which they underwent RFA treatment every 3 months until visible BE was cleared. Complete eradication of neoplasia (absence of all HGD and early cancer on biopsy and endoscopic clearance of BE) and complete eradication of intestinal metaplasia were achieved in 92% (95% CI, 83% to 93%) and 87% (95% CI, 80% to 92%), respectively, of all patients who began the study in intention-to-treat (ITT) analysis.
 
Barret et al retrospectively analyzed a prospectively enrolled cohort including 40 patients with early BE who had a visible lesion and required EMR for the visible early neoplasia lesion, followed by RFA for the residual BE, which was done at the same procedure (Barret, 2016). Follow-up was available for 34 patients at a median of 19 months. For the study’s primary outcome (complete remission of dysplasia), in the ITT analysis, remission was achieved in 85% of cohort participants; complete remission of intestinal metaplasia was achieved in 82.5% of cohort participants.
 
PRACTICE GUIDELINES AND POSITION STATEMENTS
American College of Gastroenterology
In 2016, the American College of Gastroenterology (ACG) issued guidelines for the diagnosis and management of Barrett esophagus (BE) (Shaheen, 2016), which makes statements about endoscopic therapies in general, as follows:
    • Patients with nodularity in the BE segment should undergo endoscopic mucosal resection of the nodular lesion(s) as the initial diagnostic and therapeutic maneuver…. Histologic assessment of the EMR specimen should guide further therapy. In subjects with EMR specimens demonstrating HGD, or IMC, endoscopic ablative therapy of the remaining BE should be performed. Strength: Strong LOE: High
    • In patients with EMR specimens demonstrating neoplasia at a deep margin, residual neoplasia should be assumed, and surgical, systemic, or additional endoscopic therapies should be considered. Strength: Strong LOE: Low
    • Endoscopic ablative therapies should not be routinely applied to patients with nondysplastic BE because of their low risk of progression to EAC. Endoscopic eradication therapy is the procedure of choice for patients with confirmed LGD, and confirmed HGD, as noted above. Strength: Strong LOE: Very Low
    • In patients with T1a EAC, endoscopic therapy is the preferred therapeutic approach, being both effective and well tolerated. Strength: Strong LOE: Moderate
    • In patients with T1b EAC, consultation with multidisciplinary surgical oncology team should occur before embarking on endoscopic therapy. In such patients, endoscopic therapy may be an alternative strategy to esophagectomy, especially in those with superficial (sm1) disease with a well-differentiated neoplasm lacking lymphovascular invasion, as well as those who are poor surgical candidates. Strength: Strong LOE: Low
    • Routine staging of patients with nodular BE with EUS or other imaging modalities before EMR has no demonstrated benefit. Given the possibility of over- and understaging, findings of these modalities should not preclude the performance of EMR to stage-early neoplasia. Strength: Strong LOE: Moderate
    • In patients with known T1b disease, EUS may have a role in assessing and sampling regional lymph nodes, given the increased prevalence of lymph node involvement in these patients compared with less advanced disease  Strength: Strong LOE: Moderate
    • In patients with dysplastic BE who are to undergo endoscopic ablative therapy for nonnodular disease, radiofrequency ablation is currently the preferred endoscopic ablative therapy Strength: Strong  LOE: Moderate
 
2018 Update
A literature search was conducted through June 2018.  There was no new information identified that would prompt a change in the coverage statement.  

CPT/HCPCS:
43229Esophagoscopy, flexible, transoral; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when performed)
43270Esophagogastroduodenoscopy, flexible, transoral; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when performed)
43499Unlisted procedure, esophagus

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