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BACKGROUND & AIMS: The Stretta procedure is an effective endoscopic modality for control of GERD symptoms. However, long term efficacy and safety at >10 years has not been assessed. We prospectively evaluated the long-term efficacy of Stretta at 10-years and assessed anti-secretory drug use, GERD symptoms, and patient satisfaction.
METHODS: From 8/2000 to 9/2004, 227 patients with inadequate GERD symptom control despite BID PPI underwent Stretta and were prospectively enrolled in this study. All patients had normal esophagogastric anatomy, except 16 patients with failed Nissen fundoplication and 7 with large (>3cm) hiatal hernia. All procedures were performed by a single endoscopist in an outpatient setting with conscious sedation. Baseline and follow-up GERD-HRQL scores (0-50), heartburn (0-5), satisfaction (0-5) and medication use were collected at years 1, 2, 3, 4 and 10 post-procedure. The data were analyzed using a repeated measures analysis of variance to determine whether there was a significant temporal trend in the various outcomes. Any significant effect was sub-analyzed using a Bonferroni-adjusted multiple comparison procedure.
RESULTS: The total treated pool included 227 patients (136 females, 60%). No strictures, perforation, deaths or other significant adverse events occurred. Complete follow-up was available for subjects at intervals as follows: 6 months (n=177), 1 year (n=149), 2 years (n=98), 3 years (n=98), 4 years (n=94), and 10 years (n=99). Heartburn, satisfaction, HRQL and medication use were significantly improved across the follow-up period (6, 12, 24, 36, 48, and 120 months; p<10-6 for all of the outcomes) and results were superior to those achieved for baseline drug therapy (see Table).
CONCLUSION: This 10-year, open, single center, prospective assessment of Stretta for refractory GERD demonstrates a significant and sustained improvement of GERD-HQoL scores, patient satisfaction, and improved PPI use and validates the long-term usefulness of this endoscopic procedure. Patients with variant anatomy such as prior Nissen fundoplication or large hiatal hernia had a similar response compared to patients with normal anatomy.

Parameter	Before treatment, off meds	Before procedure, on meds	0.5 years	1 year	2 years	3 years	4 years	10 years
Med Scores		8.3±3.8	4.9±3.9	3.8±3.5	3.7±4.2	4.6±3.6	4.3±3.2	4.7±3.3
GERD Scores	27.8±10.7	21.4±11.5	11.1±10.0	6.9±7.5	5.0±6.9	6.9±8.2	7.3±8.5	8.1±9.9
Satisfaction Scores	1.3±0.9	1.9±1.1	3.4±1.3	3.9±1.3	4.3±1.0	3.8±1.3	3.8±1.3	3.8±1.2