Researchers from the USA investigated the long-term safety and efficacy of radiofrequency (RF) energy delivery for the treatment of gastroesophageal reflux disease (GERD).
A total of 118 patients (72 men) with chronic heartburn and/or regurgitation were enrolled in the multicenter, prospective study.
All patients required antisecretory medication daily and had demonstrated pathologic esophageal acid exposure, a sliding hiatal hernia (2 cm), and esophagitis (grade 2).
RF energy was delivered with the Stretta catheter and thermocouple-controlled generator to create thermal lesions below the mucosa at the gastroesophageal junction.
GERD symptom scores, quality of life (SF-36), and medication use were assessed at 0, 1, 4, 6, and 12 months. Esophageal acid exposure, motility, and endoscopy were assessed at 0 and 6 months.
At 12 months, 94 patients were available for follow-up.
After 12 months there were improvements in the median heartburn score (4 to 1), GERD score (27 to 9), satisfaction (1 to 4), mental SF-36 (46 to 55), and physical SF-36 (41 to 53).
|Improvements after 12 months:|
- Heartburn/GERD scores
- Mental/physical quality of life
- Esophageal acid exposure
| Gastrointestinal Endoscopy |
The researchers found that proton pump inhibitor requirement fell from 88% to 30% of patients.
Furthermore, esophageal acid exposure improved significantly (10% to 6%).
There were 10 (9%) complications, none of which required therapeutic intervention.
Dr George Triadafilopoulos, of the VA Palo Alto Health Care System, Palo Alto, California, concluded on behalf of his group, "The Stretta procedure significantly improves GERD symptoms, quality of life, and esophageal acid exposure.
"It also eliminates the need for antisecretory medication in the majority of patients at 12 months."