Long-term maintenance effect of radiofrequency energy delivery for refractory GERD: a decade later
- Mark NoarAffiliated withHeartburn & Reflux Study Center, Endoscopic Microsurgery Associates PA Email author
- , Patrick SquiresAffiliated withSchool of Pharmacy, University of Pittsburgh
- , Emmanuelle NoarAffiliated withSchool of Medicine, Tulane University
- , Martin LeeAffiliated withSchool of Public Health, UCLA
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Patients with gastroesophageal reflux disease (GERD) often seek alternative therapy for inadequate symptom control, with over 40 % not responding to medical treatment. We evaluated the long-term safety, efficacy, and durability of response to radiofrequency treatment of the lower esophageal sphincter (Stretta).
Using an intent-to-treat analysis, we prospectively assessed 217 patients with medically refractory GERD before and after Stretta. There was no concurrent control group in the study. Primary outcome measure was normalization of GERD-health-related quality of life (GERD-HRQL) in 70 % or greater of patients at 10 years. Secondary outcomes were 50 % reduction or elimination of proton pump inhibitors (PPIs) and 60 % or greater improvement in satisfaction at 10 years. Successful treatment was defined as achievement of secondary outcomes in a minimum of 50 % of patients. Complications and effect on existing comorbidities were evaluated. The results of a 10-year study are reported.
The primary outcome was achieved in 72 % of patients (95 % confidence interval 65–79). For secondary outcomes, a 50 % or greater reduction in PPI use occurred in 64 % of patients, (41 % eliminating PPIs entirely), and a 60 % or greater increase in satisfaction occurred in 54 % of patients. Both secondary endpoints were achieved. The most common side effect was short-term chest pain (50 %). Pre-existing Barrett’s metaplasia regressed in 85 % of biopsied patients. No cases of esophageal cancer occurred.
In this single-group evaluation of 217 patients before and after Stretta, GERD-HRQL scores, satisfaction, and PPI use significantly improved and results were immediate and durable at 10 years.
KeywordsStretta GERD Medication use GERD-HRQL Reflux Radiofrequency energy Barrett's
- Long-term maintenance effect of radiofrequency energy delivery for refractory GERD: a decade later
Volume 28, Issue 8 , pp 2323-2333
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- Medication use
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- Author Affiliations
- 1. Heartburn & Reflux Study Center, Endoscopic Microsurgery Associates PA, 7402 York Road 100, Towson, MD, 21204, USA
- 2. School of Pharmacy, University of Pittsburgh, 3501 Terrace Street, Pittsburgh, PA, 15261, USA
- 3. School of Medicine, Tulane University, 1430 Tulane Ave, New Orleans, LA, 70118, USA
- 4. School of Public Health, UCLA, 640 Charles E Young Dr S, Los Angeles, CA, 90095, USA