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BACKGROUND: Ongoing acid and bile reflux are hypothesized to impair healing and squamous re-epithelialization after treatment of Barrett’s esophagus (BE) with radiofrequency ablation (RFA). It is unclear if prior fundoplication improves subsequent safety and/or efficacy of ablation. We used data from a nationwide registry of patients treated with RFA for BE to assess the relationship between prior fundoplication and these outcomes.

METHODS: The U.S. RFA Registry is a prospective study of patients with BE treated with RFA at 148 institutions (113 community-based, 35 academic-affiliated). Information collected in the registry includes demographic data, histology prior to treatment, endoscopic findings, date and number of treatment sessions, ablation outcomes, and complications. Medical therapy with proton pump inhibitors was used in subjects without fundoplication. Our safety cohort consisted of all patients treated with RFA, while our efficacy cohort was restricted to subjects who had biopsies ≥12 months after RFA treatment initiation. Complete eradication of intestinal metaplasia (CEIM) was achieved if last biopsies demonstrated no IM. We compared safety and efficacy outcomes between those with a history of fundoplication and those undergoing medical management, using parametric tests. Safety outcomes included rates of stricture, bleeding, and hospitalization. Efficacy outcomes included CEIM, complete eradication of dysplasia (CED), and number of treatment sessions to CEIM. Efficacy results are reported for the full cohort and stratified as non-dysplastic BE (NDBE) versus dysplastic BE.

RESULTS: Among 5,539 patients receiving RFA, 318 (5.7%) had a prior fundoplication. Of these subjects, 0.9% developed stricture after RFA and 1.3% were hospitalized. There were no perforations or clinically significant bleeding in the fundoplication group. Rates of stricture, bleeding, and hospitalization were not statistically different (p>0.05) between patients with and without prior fundoplication (see table). In all, 2,135 of 5,539 (39%) had biopsy data available after 12 months. CEIM and CED were achieved in 78% and 93% of subjects with a fundoplication, and 72% and 87% of subjects without a fundoplication, respectively (p>0.05 for both comparisons). Subjects with prior fundoplication had similar rates of CED, CEIM, and number of RFA sessions for eradication when compared to those without prior fundoplication (see table).

CONCLUSIONS: In the largest reported cohort of patients treated with RFA for BE, RFA in subjects with a prior fundoplication was safe and effective. However, prior fundoplication was not associated with improved efficacy or reduced number of ablation sessions, when compared to medical management using proton pump inhibitors.

Safety and efficacy outcomes among patients with and without fundoplication prior to treatment with RFA.

		FUNDOPLICATION	MEDICAL THERAPY	p-value
COMPLICATION RATES PER PATIENT	N	318	5221
	Stricture	0.9%	2.2%	0.14
	Bleeding	0	0.4%	0.27
	Hospitalization	1.3%	0.6%	0.18
EFFICACY FOR ALL SUBJECTS	N	139	1996
	CEIM	78%	72%	0.18
	CED	93%	87%	0.13
	RFA treatment sessions, mean (SD)	2.8 (1.6)	2.8 (1.6)	0.91
EFFICACY FOR NONDYSPLASTIC BE	N	79	875
	CEIM	80%	81%	0.72
	RFA treatment sessions, mean (SD)	2.7 (1.8)	2.6 (1.6)	0.68
EFFICACY FOR DYSPLASTIC BE AND IMC	N	60	1121
	CEIM	75%	65%	0.13
	CED	93%	87%	0.13
	RFA treatment sessions, mean (SD)	3.0 (1.4)	3.0 (1.6)	0.90