In this multicenter registry conducted at four community-based practices, the observed safety and efficacy outcomes associated with RFA for Barrett's esophagus are comparable to those previously reported in multicenter trials from predominantly tertiary academic centers.
Background & Aims
Radiofrequency ablation (RFA) is commonly used to treat Barrett's esophagus (BE). We assessed the incidence of esophageal adenocarcinoma (EAC) after RFA, predictors of EAC, and EAC-specific and all-cause mortality rates.
Methods
We assessed outcomes in a multicenter study of RFA for BE. Kaplan-Meier curves of EAC incidence were stratified by baseline histology. Crude EAC incidence and mortality (both all-cause and EAC-specific) rates were calculated, and adjusted all-cause mortality rates were assessed. Logistic regression models were constructed to assess predictors of EAC and all-cause mortality.
Results
Among 4982 patients, 100 (2%) developed EAC (7.8/1000 person-years (PY)), and 9 (0.2%) died of EAC (0.7/1000 PY) in a mean 2.7 ± 1.6 years. The incidence of EAC in non-dysplastic BE (NDBE) was 0.5/1000 PY. Overall, 157 (3%) patients died during follow-up (all-cause mortality 11.2/1000 PY). On multivariate logistic regression, baseline BE length (OR 1.1 per cm) and baseline histology (ORs of 5.8 and 50.3 for low grade dysplasia and high grade dysplasia (HGD) respectively) predicted EAC incidence. Among 9 EAC deaths, 6 (67%) had baseline HGD and 3 (33%) had baseline intramucosal EAC. The most common causes of death were cardiovascular (15%) and extra-esophageal cancers (15%). No deaths were associated with RFA.
Conclusion
In this multicenter registry of RFA for BE, death from EAC was rare. The incidence of EAC was markedly lower than natural history studies, with the greatest absolute benefit seen in HGD.
Summary
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.
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