Long-Term Results of Radiofrequency Energy Delivery for the Treatment of GERD: Results of a Prospective 48-Month Study

Abstract

Since 2000, radiofrequency (RF) energy treatment has been increasingly offered as an alternative option to invasive surgical procedures for selected patients with gastroesophageal reflux disease (GERD). Out of 69 patients treated since June 2002 to December 2007 with the Stretta procedure, 56 of them reached by the end of 2010 a 48-month followup. RF treatment significantly improved heartburn scores, GERD-specific quality of life scores, and general quality of life scores at 24 and 48 months in 52 out of 56 patients (92,8%). At each control time both mean heartburn and GERD HRQL scores decreased (P = 0.001 and P = 0.003, resp.) and both mental SF-36 and physical SF-36 ameliorated (P = 0.001 and 0.05, resp.). At 48 months, 41 out of 56 patients (72,3%) were completely off PPIs. Morbidity was minimal, with only one relevant but transient complication. According to other literature data, this study shows that RF delivery to LES is safe and durably improves symptoms and quality of life in well-selected GERD patients.

Figure 1

Means report 95% confidence intervals, medians report 25th and 75th percentile ranges, and proportions report percentiles. Heartburn score used a 6-point Likert scale: 0, no symptoms; 1, symptoms noticeable but not bothersome; 2, symptoms noticeable and bothersome, but not every day; 3, symptoms bothersome every day; 4, symptoms affect daily life; 5, symptoms incapacitating (unable to perform daily activities). For symptom scores, the statistical tests compared the mean/median differences in absolute change from baseline values. Heartburn and heartburn-related quality of life (HRQL) scores when off antisecretory medications (higher scores for worse symptoms). SF-36 physical score (higher scores for better function).

Figure 2

Mean Less pressure was evaluated by oesophageal manometry; median basal pressure was 8.44 mmHg (7.2–11.7), at 24 months was 9.5 (7.8–10.2) and at 48 months was 9.1 (6.9–9.2). No significant differences from baseline values were found.

Figure 3

The Stretta procedure reduces significantly the use of antireflux medication, at 48 months, 41 out of 56 patients (72,3%) were completely off PPIs (including OTC-PPIs and anti-H2 antagonists); some patients (14%) were still using only occasionally oral antacids, none of them on a weekly basis.