Radiofrequency Ablation Registry Research Articles

Surveillance After Treatment of Barrett's Esophagus Benefits Those With High-Grade Dysplasia or Intramucosal Cancer Most.

Endoscopic eradication therapy with radiofrequency ablation (RFA) and endoscopic mucosal resection is a safe and effective treatment for Barrett's esophagus. Although the outcomes of surveillance endoscopy after successful endoscopic eradication therapy have been described, no previous studies have modeled the natural history or the effect of surveillance endoscopy after successful ablation to prevent progression to invasive esophageal adenocarcinoma. The US RFA Registry is a multicenter registry consisting of patients treated with RFA for Barrett's esophagus at 148 institutions (113 community-based and 35 academic-affiliated). The authors fit models to impute the natural history of recurrence and neoplastic progression after any recurrence or retreatment. Natural history estimates of invasive adenocarcinoma after ablation therapy were compared with as-treated estimates at 5 years to derive the preventive risk difference for surveillance. Natural history estimates for the postablation progression of high-grade dysplasia (HGD) or intramucosal adenocarcinoma to invasive adenocarcinoma after treatment were 6.3% at 5 years compared with 1.3% for low-grade dysplasia (LGD). The natural history model found a much higher preventative risk difference for surveillance for HGD/intramucosal adenocarcinoma (-4.8%), compared with LGD (-1.1%). The numbers needed to surveil at 5 years were 21 and 90 for these groups, respectively, to prevent one case of invasive esophageal adenocarcinoma, making surveillance after successful ablation of baseline HGD more than 4 times as effective at preventing invasive cancer than after successful ablation of baseline LGD. Endoscopic surveillance after successful ablation of baseline HGD or intramucosal cancer is much more effective than surveillance after successful treatment of baseline LGD in averting invasive adenocarcinoma. Although the modest benefits of surveillance for treated LGD may be greater than the risks for patients at average risk for adverse effects of endoscopy, clinicians should concentrate on retaining patients with baseline HGD or cancer in endoscopic surveillance programs.

Endoscopic eradication therapy for Barrett’s esophagus–related neoplasia: a final 10-year report from the UK National HALO Radiofrequency Ablation Registry

Long-term durability data for effectiveness of radiofrequency ablation (RFA) to prevent esophageal adenocarcinoma in patients with dysplastic Barrett's esophagus (BE) are lacking. We prospectively collected data from 2535 patients with BE (mean length, 5.2 cm; range, 1-20) and neoplasia (20% low-grade dysplasia, 54% high-grade dysplasia, 26% intramucosal carcinoma) who underwent RFA therapy across 28 UK hospitals. We assessed rates of invasive cancer and performed detailed analyses of 1175 patients to assess clearance rates of dysplasia (CR-D) and intestinal metaplasia (CR-IM) within 2 years of starting RFA therapy. We assessed relapses and rates of return to CR-D (CR-D2) and CR-IM (CR-IM2) after further therapy. CR-D and CR-IM were confirmed by an absence of dysplasia and intestinal metaplasia on biopsy samples taken at 2 consecutive endoscopies. Ten years after starting treatment, the Kaplan-Meier (KM) cancer rate was 4.1% with a crude incidence rate of .52 per 100 patient-years. CR-D and CR-IM after 2 years of therapy were 88% and 62.6%, respectively. KM relapse rates were 5.9% from CR-D and 18.7% from CR-IM at 8 years, with most occurring in the first 2 years. Both were successfully retreated with rates of CR-D2 of 63.4% and CR-IM2 of 70.0% 2 years after retreatment. EMR before RFA increased the likelihood of rescue EMR from 17.2% to 41.7% but did not affect the rate of CR-D, whereas rescue EMR after RFA commenced reduced CR-D from 91.4% to 79.7% (χ2P< .001). RFA treatment is effective and durable to prevent esophageal adenocarcinoma. Most treatment relapses occur early and can be successfully retreated.

Trends in ablation procedures in Greece over the 2008-2018 period: Results from the Hellenic Cardiology Society Ablation Registry

ObjectiveIn 2008, the radiofrequency ablation (RFA) procedures registry of the Hellenic Society of Cardiology was created. This online database allowed electrophysiologists around the country to input data for all performed ablation procedures. The aim of this study is to provide a thorough report and interpretation of the data submitted to the registry between 2008 and 2018. MethodsIn 2008, a total of 27 centers/medical teams in 24 hospitals were licensed to perform RFA in Greece. By 2018, the number had risen to 31. Each center was tasked with inserting their own data into the registry, which included patient demographics (anonymized), type of procedure and technique, complications, and outcomes. ResultsA total of 18587 procedures in 17900 patients were recorded in the period of 2008-2018. By 2018, slightly more than 70% of procedures were performed in 7 high-volume centers (>100 cases/year). The most common procedure since 2014 was atrial fibrillation ablation, followed by atrioventricular nodal reentry tachycardia ablation. Complication rates were low, and success rates remained high, whereas the 6-month relapse rates declined steadily. ConclusionThis online RFA registry has proved that ablation procedures in Greece have reached a very high standard, with results and complication rates comparable to European and American standards. Ablation procedures for atrial fibrillation are increasing constantly, with it being the most common intervention over the last 6-year period, although the absolute number of procedures still remains low, compared to other European countries.

Learning curves and the influence of procedural volume for the treatment of dysplastic Barrett’s esophagus

Endoscopic resections and radiofrequency ablation (RFA) are the established treatments for Barrett's-associated dysplasia and early esophageal neoplasia. The UK RFA Registry collects patient outcomes from 24 centers treating patients in the United Kingdom and Ireland. Learning curves for treatment of Barrett's dysplasia and the impact of center caseload on patient outcomes is still unknown. We examined outcomes of 678 patients treated with RFA in the UK Registry using risk-adjusted cumulative sum control chart (RA-CUSUM) analysis to identify change points in complete resolution of intestinal metaplasia (CR-IM) and complete resolution of dysplasia (CR-D) outcomes. We compared outcomes between those treated at high-volume (>100 enrolled patients), medium-volume (51-100), and low-volume (<50) centers. There was no association between center volume and CR-IM and CR-D rates, but recurrence rates were lower in high-volume versus low-volume centers (log rank P= .001). There was a significant change point for outcomes at 12 cases for CR-D (reduction from 24.5% to 10.4%; P< .001) and at 18 cases for CR-IM (30.7% to 18.6%; P< .001) from RA-CUSUM curve analysis. Our data suggest that 18 supervised cases of endoscopic ablation may be required before competency in endoscopic treatment of Barrett's dysplasia can be achieved. The difference in outcomes between a high-volume and low-volume center does not support further centralization of services to only high-volume centers.

Efficacy and safety of radiofrequency ablation of Barrett's esophagus in the absence of reimbursement: a multicenter prospective Belgian registry.

Radiofrequency ablation (RFA), combined with endoscopic resection, can be used as a primary treatment for low grade dysplasia, high grade dysplasia, and early esophageal adenocarcinoma (EAC) in Barrett's esophagus (BE). The aim of the Belgian RFA registry is to capture the real-life outcome of endoscopic therapy for BE with RFA and to assess efficacy and safety outside study protocols, in the absence of reimbursement. Between February 2008 and January 2017, data from 7 different expert centers were prospectively collected in the registry. Efficacy outcomes included complete remission of intestinal metaplasia (CR-IM), complete remission of dysplasia (CR-D), and durability of remission. Safety outcomes included immediate and late adverse events. 684 RFA procedures in 342 different patients were registered. Of these, 295 patients were included in the efficacy analysis, with CR-IM achieved in 88 % and CR-D in 93 %, in per-protocol analysis; corresponding rates in intention-to-treat analysis were 82 % and 87 %, respectively. Sustained remission was seen in 65 % with a median (interquartile range) follow-up of 25 (12 - 47) months. No risk factors for recurrent disease were identified. Immediate complications occurred in 4 % of all procedures and 6 % of all patients, whereas late complications occurred in 9 % of all procedures and in 20 % of all patients. Data from the Belgian registry confirm that RFA in combination with endoscopic resection is an efficient treatment for BE with dysplasia or early EAC. In the absence of reimbursement, more rescue treatments are used, not compromising outcome. Since there is recurrent disease after CR-IM in 35 %, surveillance endoscopy remains necessary.

Development of Evidence-Based Surveillance Intervals After Radiofrequency Ablation of Barrett’s Esophagus

Barrett's esophagus (BE) recurs in 25% or more of patients treated successfully with radiofrequency ablation (RFA), so surveillance endoscopy is recommended after complete eradication of intestinal metaplasia (CEIM). The frequency of surveillance is informed only by expert opinion. We aimed to model the incidence of neoplastic recurrence, validate the model in an independent cohort, and propose evidence-based surveillance intervals. We collected data from the United States Radiofrequency Ablation Registry (US RFA, 2004-2013) and the United Kingdom National Halo Registry (UK NHR, 2007-2015) to build and validate models to predict the incidence of neoplasia recurrence after initially successful RFA. We developed 3 categories of risk and modeled intervals to yield 0.1% risk of recurrence with invasive adenocarcinoma. We fit Cox proportional hazards models assessing discrimination by Cstatistic and 95% confidence limits. The incidence of neoplastic recurrence was associated with most severe histologic grade before CEIM, age, endoscopic mucosal resection, sex, and baseline BE segment length. In multivariate analysis, a model based solely on most severe pre-CEIM histology predicted neoplastic recurrence with a C statistic of 0.892 (95% confidence limit, 0.863-0.921) in the US RFA registry. This model also performed well when we used data from the UK NHR. Our model divided patients into 3 risk groups based on baseline histologic grade: non-dysplastic BE; indefinite for dysplasia, low-grade dysplasia, and high-grade dysplasia; or intramucosal adenocarcinoma. For patients with low-grade dysplasia, we propose surveillance endoscopy at 1 and 3 years after CEIM; for patients with high-grade dysplasia or intramucosal adenocarcinoma, we propose surveillance endoscopy at 0.25, 0.5, and 1 year after CEIM, then annually. In analyses of data from the US RFA and UK NHR for BE, a much-attenuated schedule of surveillance endoscopy would provide protection from invasive adenocarcinoma. Adherence to the recommended surveillance intervals could decrease the number of endoscopies performed yet identify unresectable cancers at rates less than 1/1000 endoscopies.

PWE-077 Residual Intestinal Metaplasia after Successful Endoscopic Therapy for Barrett’s Related Neoplasia Confers Higher Long Term Risk for Disease Recurrence, on Behalf of The UK RFA Registry

<h3>Introduction</h3> Endoscopic resection (ER) followed by Radiofrequency ablation (RFA) is the first line treatment for neoplastic Barrett’s oesophagus (BE). Metachronous neoplasia after focal eradication of disease is ~20%. We examine data from the UK registry of 28 centres to establish if residual metaplastic BE carries a risk of disease recurrence. <h3>Methods</h3> Visible lesions were removed by EMR. Patients then underwent RFA 3 monthly. Biopsies were taken at 12 months to assess treatment success with repeat biopsies every 6–12 months thereafter. Dysplasia recurrence was compared in patients who had complete reversal of BE and neoplasia (CR-IM) to those in whom dysplasia alone was eradicated (CR-D only). Residual BE was confirmed with visible columnar epithelium proximal to the OGJ with biopsies showing IM. <h3>Results</h3> 517 patients achieved CR-IM &amp; 96 patients achieved CR-D only after 12 months treatment . Sex &amp; ER rates were not significantly different between groups. The CR-D only group were older (mean age 70 vs 67, p &lt; 0.01) and had longer initial BE (mean length 6.2 cm vs 4.7 cm, p &lt; 0.0001). Mean residual BE length was 1.4 cm. At median follow up 32 months, more patients were disease free in the CR-IM group (96% vs 89%) and Kaplan Meier statistics demonstrated an improved predicted 6 year neoplasia free survival in the CR-IM group (90% vs 84% log rank p 0.0015). Most recurrences occurred within 3 years of follow up. <h3>Conclusion</h3> Endotherapy should aim to clear neoplasia and underlying metaplastic BE to improve long term outcome. Patients with CR-D but not CR-IM at the end of treatment have an increased risk of neoplasia recurrence. This may have implications for post treatment surveillance intervals. <h3>Disclosure of Interest</h3> None Declared

887 Evidence-based Surveillance Intervals Following Radiofrequency Ablation (RFA) of Barrett’s Esophagus (BE): An Analysis of Recurrence in the US RFA Registry with Validation in the UK National Halo Registry

887 Evidence-based Surveillance Intervals Following Radiofrequency Ablation (RFA) of Barrett’s Esophagus (BE): An Analysis of Recurrence in the US RFA Registry with Validation in the UK National Halo Registry

841 Residual Intestinal Metaplasia After Successful Endoscopic Therapy for Barrett's Related Neoplasia Confers Higher Long Term Risk for Disease Recurrence, on Behalf of the UK RFA Registry

Introduction Endoscopic resection (ER) followed by Radiofrequency ablation (RFA) is the first line treatment for neoplastic Barrett’s oesophagus (BE). Metachronous neoplasia after focal eradication of disease is ~20%. We examine data from the UK registry of 28 centres to establish if residual metaplastic BE carries a risk of disease recurrence. Methods Visible lesions were removed by EMR. Patients then underwent RFA 3 monthly. Biopsies were taken at 12 months to assess treatment success with repeat biopsies every 6–12 months thereafter. Dysplasia recurrence was compared in patients who had complete reversal of BE and neoplasia (CR-IM) to those in whom dysplasia alone was eradicated (CR-D only). Residual BE was confirmed with visible columnar epithelium proximal to the OGJ with biopsies showing IM. Results 517 patients achieved CR-IM & 96 patients achieved CR-D only after 12 months treatment . Sex & ER rates were not significantly different between groups. The CR-D only group were older (mean age 70 vs 67, p Conclusion Endotherapy should aim to clear neoplasia and underlying metaplastic BE to improve long term outcome. Patients with CR-D but not CR-IM at the end of treatment have an increased risk of neoplasia recurrence. This may have implications for post treatment surveillance intervals. Disclosure of Interest None Declared

Effects of preceding endoscopic mucosal resection on the efficacy and safety of radiofrequency ablation for treatment of Barrett's esophagus: results from the United States Radiofrequency Ablation Registry: Effect of prior EMR on RFA efficacy

Effects of preceding endoscopic mucosal resection on the efficacy and safety of radiofrequency ablation for treatment of Barrett's esophagus: results from the United States Radiofrequency Ablation Registry: Effect of prior EMR on RFA efficacy

Incidence of Adenocarcinoma of the Gastric Cardia Is Similar to That of Adenocarcinoma in the Esophagus After Successful Radiofrequency Ablation in Barrettʼs Esophagus

Introduction: Radiofrequency ablation (RFA) is an effective treatment for Barrett's Esophagus (BE) that results in high rates of complete eradication of intestinal metaplasia (CEIM). Despite RFA, progression to adenocarcinoma may occur, in either the tubular esophagus or the gastric cardia. We sought to describe the rate and timing of gastric cardia adenocarcinoma after RFA for BE. Methods: The U.S. RFA Registry is a national, prospective study of patients with Barrett's Esophagus (BE) treated with RFA at 148 institutions (113 community-based, 35 academic-affiliated). We included patients without prevalent adenocarcinoma. We estimated the incidence rate of gastric cardia adenocarcinoma overall and stratified by CEIM status with profile-likelihood confidence limits (CL). We performed inverse probability of sampling weighting to estimate incidence rates of cardia adenocarcinoma among patients with cardia sampling under a scenario of universal sampling. We estimated unadjusted and adjusted rate ratios for cardia adenocarcinoma among the full population and among the standardized, sampled population. Results: Of 5,521 patients in the registry, 5,085 without prevalent adenocarcinoma were included for analysis. Baseline characteristics are described in table 1. There were 21 incident cases of cardia adenocarcinoma, of which 13 occurred before or at the time of esophageal CEIM and 8 occurred during surveillance. In the full population, the overall incidence of cardia adenocarcinoma was 1.49 per 1,000 person-years (95% CL: 0.94 - 2.22), prior to CEIM was 2.23 (95% CL: 1.23 - 3.68), and after CEIM was 0.97 (95% CL: 0.45 - 1.81). In the sampled, standardized population the overall incidence of cardia adenocarcinoma was 3.03 per 1,000 person-years (95% CL: 2.02 - 4.34), prior to CEIM was 5.89 (95% CL: 3.54 - 9.11), and after CEIM was 1.58 (95% CL: 0.76 - 2.85). Incidence of cardia adenocarcinoma was much less than incidence of esophageal adenocarcinoma before CEIM (13.4 per 1,000 person-years) but similar to after CEIM (2.60 per 1,000 person-years). Conclusion: Cardia adenocarcinoma incidence is similar to esophageal adenocarcinoma incidence after successful RFA. Both cardia and esophageal adenocarcinoma are strongly associated with baseline histologic grade and less common after CEIM. Nearly half of U.S. RFA registry patients never had pathologic examination of the cardia, suggesting that neoplasia may be missed without routine sampling of the cardia.Table 1: Baseline clinical and endoscopic characteristics of 5,085 patients in the U.S. RFA registry dataset, 2,327 patients with cardia sampling, and the inverse probability of sampling weighted pseudo-populationTable 2: Unadjusted and adjusted rate ratios for the incidence of gastric cardia adenocarcinoma among U.S. RFA registry patients and the standardized population with cardia samplingFigure 1

Initial Treatment With Endoscopic Mucosal Resection Decreases the Incidence of Esophageal Adenocarcinoma in Patients With Barrettʼs, With High-Grade Dysplasia

Introduction: Endoscopic mucosal resection (EMR) is effective for the removal of nodular neoplastic mucosa in Barrett's esophagus (BE) with high grade dysplasia (HGD). While EMR is commonly performed prior to ablation, the impact of early EMR on the subsequent risk of esophageal adenocarcinoma (EAC) after radiofrequency ablation (RFA) is unknown. We compared outcomes of patients with HGD who had EMR then RFA to patients with HGD who had RFA alone. Methods: The U.S. RFA Registry is a study of RFA for BE at 148 centers. Patients were enrolled from 2007-2011 and followed prospectively until 2014. For inclusion in the current investigation, patients had HGD and were free from EAC at baseline. We compared HGD patients receiving EMR prior to RFA to HGD patients receiving RFA alone using Wilcoxon rank sum test for continuous variables and chi-square testing for categorical variables. Logistic regression models were constructed to assess odds ratios (OR) for EAC. Results: Among 5521 patients in the registry, 974 (18%) had HGD. Of these 974, 237 (24%) underwent EMR prior to RFA. Patients who underwent EMR prior to RFA did not differ from those who got RFA alone on age, race, gender, frequency of complete eradication of intestinal metaplasia (CEIM), or time in study, but did have shorter BE at baseline (4.7 vs 5.3 cm, p = 0.008) (Table). Amongst all patients with HGD, 83 (9%) developed EAC. Patients undergoing EMR prior to RFA were less likely to develop EAC (5% vs 10%, p = 0.03) or invasive EAC (2% vs 5%, p = 0.04). On logistic regression, after controlling for age, race, gender, BE length, and time in study, patients who did not undergo initial EMR had doubled odds of developing EAC (OR 1.9, 95% CI [1.01-3.6]). The impact of EMR on invasive EAC was similar in magnitude but did not reach significance after adjustment for the same factors (OR 2.7, 95% CI [0.94-7.7]). Conclusion: After controlling for multiple potential confounders, patients with HGD who received EMR prior to RFA were less likely to develop EAC than HGD patients treated with RFA alone. Since nodularity within BE is a risk factor for EAC, this finding is counter-intuitive. The performance of EMR may be a marker for closer mucosal inspection, leading to superior outcomes. Alternatively, facilities able to perform EMR may also perform more effective RFA. Facilities not able to perform EMR may be more likely to perform RFA over areas of nodularity. Early EMR appears to have a role in protecting against EAC.Table 1: Patient Characteristics by EMR performed prior to RFA

Effects of preceding endoscopic mucosal resection on the efficacy and safety of radiofrequency ablation for treatment of Barrett's esophagus: results from the United States Radiofrequency Ablation Registry.

The effects of preceding endoscopic mucosal resection (EMR) on the efficacy and safety of radiofrequency ablation (RFA) for treatment of nodular Barrett's esophagus (BE) is poorly understood. Prior studies have been limited to case series from individual tertiary care centers. We report the results of a large, multicenter registry. We assessed the effects of preceding EMR on the efficacy and safety of RFA for nodular BE with advanced neoplasia (high-grade dysplasia or intramucosal carcinoma) using the US RFA Registry, a nationwide study of BE patients treated with RFA at 148 institutions. Safety outcomes included stricture, gastrointestinal bleeding, and hospitalization. Efficacy outcomes included complete eradication of intestinal metaplasia (CEIM), complete eradication of dysplasia (CED), and number of RFA treatments needed to achieve CEIM. Analyses comparing patients with EMR before RFA to patients undergoing RFA alone were performed with Student's t-test, Chi-square test, logistic regression, and Kaplan-Meier analysis. Four hundred six patients were treated with EMR before RFA for nodular BE, and 857 patients were treated with RFA only for non-nodular BE. The total complication rates were 8.4% in the EMR-before-RFA group and 7.2% in the RFA-only group (P = 0.48). Rates of stricture, bleeding, and hospitalization were not significantly different between patients treated with EMR before RFA and patients treated with RFA alone. CEIM was achieved in 84% of patients treated with EMR before RFA, and 84% of patients treated with RFA only (P = 0.96). CED was achieved in 94% and 92% of patients in EMR-before-RFA and RFA-only group, respectively (P = 0.17). Durability of eradication did not differ between the groups. EMR-before-RFA for nodular BE with advanced neoplasia is effective and safe. The preceding EMR neither diminished the efficacy nor increased complication rate of RFA treatment compared to patients with advanced neoplasia who had RFA with no preceding EMR. Preceding EMR is not associated with poorer outcomes in RFA.

PTH-180 Outcomes of patients who fail initial endoscopic therapy for barrett’s related neoplasia

<h3>Introduction</h3> Endoscopic therapy with Endoscopic mucosal resection (EMR) followed by Radiofrequency ablation (RFA) is now recommended as first line treatment for patients with Barrett’s oesophagus (BE) related neoplasia confined to the mucosa. <h3>Method</h3> We examine prospective data from the United Kingdom registry of patients undergoing RFA/EMR for BE neoplasia to examine eventual outcomes of patients who do not have disease reversal at 12 months. All patients were treated with a recommended 12 month treatment protocol where before RFA, visible lesions and nodularity were entirely removed by EMR. Thereafter patients underwent RFA every 3 months until all visible BE was ablated. Biopsies were taken at around 12 months to access for treatment success. Those with residual dysplasia at this stage were offered further treatment and analysed here. Patients with a minimum of 24 months follow up were reviewed. <h3>Results</h3> 283 patients (81% male, mean age 70 years, 72% HGD, 24% IMC, 4% LGD) completed the 12 month treatment protocol and the majority 90% (255 patients) had reversal of neoplasia (CR-D) at 12 months with 2–3 RFA treatments. Of these with CR-D only one patient has subsequently progressed to invasive cancer (31 months after treatment). 28 patients had refractory neoplasia and were offered further endoscopic treatment. In these CR-D has been achieved in 67% (19/28) after 1–3 RFA treatments and all are free of neoplasia at median follow up of 46 months form initiating treatment. 3 patients in this cohort of non-responders progressed to invasive disease and the remainder (n = 6) are undergoing on going treatment. <h3>Conclusion</h3> The majority of patients with BE neoplasia will achieve successful disease reversal within a structured 12 month treatment program. However in the few that have residual neoplasia at this stage further RFA can be successfully used to eradicate neoplasia. Surgery for those fit remains a definitive treatment choice for the minority who do not respond to initial treatment or progress to invasive disease despite further treatment. All collaborators of the UK RFA registry are acknowledged for their contributions to data collection for this work <h3>Disclosure of interest</h3> None Declared.

Tu1560 The Effect of Pre-Treatment Stricture on Outcomes After Radiofrequency Ablation (RFA) for Barrett's Esophagus: Results From the U.S. RFA Registry

Tu1560 The Effect of Pre-Treatment Stricture on Outcomes After Radiofrequency Ablation (RFA) for Barrett's Esophagus: Results From the U.S. RFA Registry

Tu1559 Safety of Same-Session Cryotherapy and Esophageal Stricture Dilation in the Treatment of Esophageal Neoplasia- a Multicenter Study

Tu1559 Safety of Same-Session Cryotherapy and Esophageal Stricture Dilation in the Treatment of Esophageal Neoplasia- a Multicenter Study

Sex and race and/or ethnicity differences in patients undergoing radiofrequency ablation for Barrett’s esophagus: results from the U.S. RFA Registry

Little is known about differences in Barrett's esophagus (BE) characteristics by sex and race and/orethnicity or these differences in response to radiofrequency ablation (RFA). We compared disease-specific characteristics, treatment efficacy, and safety outcomes by sex and raceand/or ethnicity in patients treated with RFA for BE. The U.S. RFA patient registry is a multicenter collaboration reporting processes and outcomes of care forpatients treated with RFA for BE. Patients enrolled with BE. RFA. We assessed safety (stricture, bleeding, perforation, hospitalization), efficacy(complete eradication of intestinal metaplasia [CEIM]), complete eradication of dysplasia, and number of treatments to CEIM by sex and race and/or ethnicity. Among 5521 patients (4052 men; 5126 white, 137 Hispanic, 82 African American, 40 Asian, 136 heritage not identified), women were younger (60.0 vs 62.1 years) and had shorter BE segments (3.2 vs 4.4 cm) and lessdysplasia (37% vs 57%) than did men. Women were almost twice as likely to stricture (odds ratio 1.7; 95% confidence interval, 1.2-2.3). Although white patients were predominantly male, about half of African Americans and Asians with BE were female. African Americans and Asians had less dysplasia than white patients. Asians and African Americans had more strictures than did white patients. There were no sex or race differences in efficacy. Observational study with non-mandated paradigms, no central laboratory for reinterpretation of pathology. In the U.S. RFA patient registry, women had shorter BE segments and less-aggressive histology. Theusual tendency toward BE in men was absent in African Americans and Asians. Posttreatment stricture was more common among women and Asians. RFA efficacy did not differ by sex or race.

Sa1081 Outcomes of Patients Who Fail Initial Endoscopic Therapy for Barrett's Related Neoplasia

Introduction Endoscopic therapy with Endoscopic mucosal resection (EMR) followed by Radiofrequency ablation (RFA) is now recommended as first line treatment for patients with Barrett’s oesophagus (BE) related neoplasia confined to the mucosa. Method We examine prospective data from the United Kingdom registry of patients undergoing RFA/EMR for BE neoplasia to examine eventual outcomes of patients who do not have disease reversal at 12 months. All patients were treated with a recommended 12 month treatment protocol where before RFA, visible lesions and nodularity were entirely removed by EMR. Thereafter patients underwent RFA every 3 months until all visible BE was ablated. Biopsies were taken at around 12 months to access for treatment success. Those with residual dysplasia at this stage were offered further treatment and analysed here. Patients with a minimum of 24 months follow up were reviewed. Results 283 patients (81% male, mean age 70 years, 72% HGD, 24% IMC, 4% LGD) completed the 12 month treatment protocol and the majority 90% (255 patients) had reversal of neoplasia (CR-D) at 12 months with 2–3 RFA treatments. Of these with CR-D only one patient has subsequently progressed to invasive cancer (31 months after treatment). 28 patients had refractory neoplasia and were offered further endoscopic treatment. In these CR-D has been achieved in 67% (19/28) after 1–3 RFA treatments and all are free of neoplasia at median follow up of 46 months form initiating treatment. 3 patients in this cohort of non-responders progressed to invasive disease and the remainder (n = 6) are undergoing on going treatment. Conclusion The majority of patients with BE neoplasia will achieve successful disease reversal within a structured 12 month treatment program. However in the few that have residual neoplasia at this stage further RFA can be successfully used to eradicate neoplasia. Surgery for those fit remains a definitive treatment choice for the minority who do not respond to initial treatment or progress to invasive disease despite further treatment. All collaborators of the UK RFA registry are acknowledged for their contributions to data collection for this work Disclosure of interest None Declared.

53 Six Year Disease Durability Outcomes on Patients Treated With Endoscopic Therapy for Barrett's Related Neoplasia From the UK Registry

Introduction Endoscopic therapy with combined Endoscopic mucosal resection (EMR) followed by Radiofrequency ablation (RFA) is now the recommended first line treatment for patients with Barrett’s (BE) related neoplasia confined to the oesophageal mucosa. Method We examine prospective data from the United Kingdom registry of patients undergoing RFA/EMR for BE neoplasia since 2008. Before RFA, visible lesions and nodularity were entirely removed by EMR. Thereafter patients underwent RFA 3 monthly until all visible BE was ablated or cancer developed (endpoints). Biopsies were taken at 12 months or when endpoints reached. Follow up endoscopies were performed periodically in all patients to check for recurrences thereafter. All patients who had completed at least 12 months of follow up after successful treatment were included in the analysis to examine durability of disease reversal long term. Results 282 patients (81% male, mean age 70 years) have completed the 12 month treatment protocol with a minimum of 12 months follow up thereafter. At median follow up of 37 months (IQR 29–49), 93% of patients with successful disease reversal were still free of neoplasia and 88% free of intestinal metaplasia recurrence. Cancer progression at this same time was seen in 1.4% of patients. Kaplan Meier (KM) statistics demonstrated a predicted 3 year neoplasia free survival in 88% of patients. At 5 and 6 years this was 86%. Similarly KM analysis showed that at 3 years 81% of patients would be free form BE and at 5 and 6 years this figure was 73%. Conclusion We report long term outcomes of a large cohort of patients with BE neoplasia who have had successful endoscopic therapy with RFA/EMR. This approach appears to have a lasting disease free benefit in the majority of patients. Recurrences do occur in a minority of patients and highlights the need for follow up in those fit for endoscopy. All collaborators of the UK RFA registry are acknowledged for their contributions to data collection for this work. Disclosure of interest None Declared.

Site Volume is Inversely Associated With Recurrence Rate After Successful Radiofrequency Ablation (RFA): An Analysis of the U.S. RFA Registry

Introduction: Factors associated with recurrent Barrett’s esophagus (BE) after successful eradication are poorly understood. We used the U.S. RFA registry to assess the relationship between site volume and recurrence of intestinal metaplasia (IM) in the U.S. RFA registry. Methods: The U.S. RFA registry is a national study of patients with BE treated with RFA at 148 institutions (113 community-based, 35 academic). We assessed the rate of recurrence of IM after initial complete eradication of IM. We divided the sites into quintiles by number of registry subjects enrolled, such that those in the 1st quintile enrolled ≤7 patients, while those in the 5th quintile enrolled ≥56. We used Kaplan-Meier estimation and proportional hazards models to assess the association of site volume with the rate of recurrence of IM.Figure 1Results: Recurrence of IM occurred at a higher rate in smaller centers (Table 1). For each increase in quintile, the hazard ratio (HR) for recurrence was 0.70 [0.64, 0.77]. The HR was somewhat attenuated, but persisted, after adjustment for initial histology, academic vs. community, race/ethnicity, BE length, age, and order treated (aHR = 0.81 [0.72, 0.90]).Table 1: Characteristics of 2072 Patients at 148 RFA Sites by Quintile of VolumeConclusion: There is a strong association between site volume and the rate of recurrence of intestinal metaplasia after initially successful RFA, with smaller volume sites demonstrating higher recurrence rates. This association persisted after controlling for potential confounders. Disclosure - Dr. Shaheen receives research funding from GI Solutions, a subsidiary of Covidien. This research was supported by an industry grant from This research was funded by GI Solutions, a subsidiary of Covidien.