Long-term results of radiofrequency energy delivery for the treatment of GERD. Results of a 48 month prospective study.

Diagnostic and Therapeutic Endoscopy, August 2011

BACKGROUND: In April 2000 the FDA approved the Stretta® system (Curon Medical, Fremont CA, USA) for use as an endoscopic treatment for patients with GERD [5] that was increasingly offered as first-line therapy before more invasive surgical procedures for selected GERD patients, with clinical data supporting its efficacy, safety, and patient satisfaction.

The device imparts RF ablation to the dysfunctional lower oesophageal sphincter via the endoscopic balloon-mounted needles. Energy is applied at six to eight levels circumferentially around the oesophageal junction. Two main goals are achieved: first, scarring of the distal oesophageal muscular wall improves the reflux barrier of the lower oesophageal sphincter; second, reduced transient lower oesophageal sphincter relaxations occur due to ablation or demodulation of vagal afferent fibres in the vicinity. The current study reports our experience using the Stretta procedure in strictly selected patients suffering of GERD who have been followed up for 4 years.

RESULTS: All 56 patients completed the protocol and accepted to undergo oesophageal manometry at 24 and 48 months. 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, respectively) and both mental SF-36 and physical SF-36 ameliorated (p = 0.001 and 0.05, respectively). Whereas in our cohort of patients the median LES pressure was previously described to increase at 12 months, [15,16]  only an overall not significant effect from baseline and post-treatment values was finally observed at 24 and 48 months (Figure 2). At 48 months, 41 out of 56 patients (72,3%) were completely off PPIs, someone using only occasionally oral antacids (figure 3). There were no post procedure perforations, mucosal lacerations, bleeding episodes requiring transfusion, or deaths (Table 2). Minor complications were temporary post procedure chest discomfort, requiring only oral analgesics, mild fever, transient nausea and vomiting  and transient dysphagia. The only major adverse event was a prolonged transient gastroparesis in a 52 years old male patient. The patient had to be hospitalized for 3 weeks and treated with prokinetics, prostigmine and enteral nutrition. The problem was completely resolved within approximately 8 weeks.

CONCLUSION: At this time, in the long-term follow up studies the Stretta procedure has been proven to be very safe for the treatment of GERD. In conclusion, according to literature data our study confirms that RF energy delivery is safe and effective and produces durable and significant improvement in GERD symptoms and quality of life as well as reduces the use of antireflux medication, with negligible morbidity.