Sustained improvement in symptoms of GERD and antisecretory drug use: 4-year follow-up of the Stretta procedure.
BACKGROUND
Approximately 20% of patients with GERD do not respond to medical therapy. The Stretta radiofrequency antireflux procedure represents an alternative to failed drug therapy for GERD.


OBJECTIVE
The aim of this study was to assess symptom and medication changes after the Stretta procedure during a 4-year follow-up period.


METHODS
Prospective case series on intent-to-treat basis.


METHODS
Community practice.


METHODS
Patients with GERD with persistent symptoms despite twice-daily proton pump inhibitor (PPI) medications.


METHODS
The Stretta procedure was performed in drug-refractory patients with GERD diagnosed by the presence of endoscopically evidenced esophagitis or abnormal esophageal pH testing. Symptom assessment was performed with a validated health-related quality-of-life questionnaire (with and without medication) at baseline and 6, 12, 24, 36, and 48 months after treatment. Complications of the procedure and medication usage were analyzed.


METHODS
Significant changes in symptom scores, GERD quality-of-life parameters, and medication usage on the basis of clinical outcomes.


RESULTS
We report on a series of 109 consecutive patients treated with the Stretta procedure who have reached 4-year follow-up. Complete long-term follow-up assessment was available in matched data for 109 patients at 12 months, 108 patients at 24 months, 102 patients at 36 months, and 96 patients at 48 months. A second procedure was performed in 13 patients. Heartburn scores decreased from 3.6 to 1.18 (P < .001), total heartburn score (GERD health-related quality-of-life questionnaire) decreased from 27.8 to 7.1 (P < .001), and patient satisfaction improved from 1.4 to 3.8 (P < .001) (see ). Medication usage decreased significantly from 100% of patients on twice-daily PPI therapy at baseline to 75% of patients showing elimination of medications or only as-needed use of antacids/over-the-counter PPIs at 48 months (P < 0.005). There were no serious complications of the procedure.


CONCLUSIONS
This is an uncontrolled, nonrandomized case series in consecutive patients that does not include long-term pH or motility studies.


CONCLUSIONS
This study in drug-refractory patients with GERD found the Stretta procedure to be a safe, effective, and durable treatment that produced significant improvements in heartburn and quality of life and decreased medication usage during a 4-year period of follow-up.
Noar
Mark D
MD
Heartburn and Reflux Study Center, Endoscopic Microsurgery Associates, 7402 York Road, Towson, MD 21204, USA.
Lotfi-Emran
Sahar
S
D000328:Adult; D000368:Aged; D017115:Catheter Ablation / Q000379:methods*; D016099:Endoscopy, Gastrointestinal; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D004947:Esophagus / Q000378:metabolism / Q000503:physiopathology; D005260:Female; D005500:Follow-Up Studies; D005745:Gastric Acidity Determination; D005764:Gastroesophageal Reflux / Q000188:drug therapy / Q000523:psychology / Q000601:surgery; D005769:Gastrointestinal Motility; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D054328:Proton Pump Inhibitors; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
D004791:Enzyme Inhibitors; D054328:Proton Pump Inhibitors