Four-year follow-up of endoscopic gastroplication for the treatment of gastroesophageal reflux disease

Abstract

Aim: To evaluate the long-term effect of Endocinch treatment for gastroesophageal reflux disease (GERD).

Methods: After unblinding and crossover, 50 patients (32 males, 18 females; mean age 46 years) with pH-proven chronic GERD were recruited from an initial randomized, placebo-controlled, single-center study, and included in the present prospective open-label follow-up study. Initially, three gastroplications using the Endocinch device were placed under deep sedation in a standardized manner. Optional retreatment was offered in the first year with 1 or 2 extra gastroplications. At baseline, 3 mo after (re) treatment and yearly proton pump inhibitor (PPI) use, GERD symptoms, quality of life (QoL) scores, adverse events and treatment failures (defined as: patients using > 50% of their baseline PPI dose or receiving alternative antireflux therapy) were assessed. Intention-to-treat analysis was performed.

Results: Median follow-up was 48 mo [interquartile range (IQR): 38-52]. Three patients were lost to follow-up. In 44% of patients retreatment was done after a median of 4 mo (IQR: 3-8). No serious adverse events occurred. At the end of follow-up, symptom scores and 4 out of 6 QoL subscales were improved (all P < 0.01 compared to baseline). However, 80% of patients required PPIs for their GERD symptoms. Ultimately, 64% of patients were classified as treatment failures. In 60% a post-procedural endoscopy was carried out, of which in 16% reflux esophagitis was diagnosed.

Conclusion: In the 4-year follow-up period, the subset of GERD patients that benefit from endoscopic gastroplication kept declining gradually, nearly half opted for retreatment and 80% required PPIs eventually.

Keywords: Endocinch; Endoscopic therapy; Follow-up studies; Gastroesophageal Reflux; Gastroplication.

Figure 1

Flow diagram of follow-up. ¹Between 12 and 48 mo, 9 patients had antireflux treatment: 8 patients underwent antireflux surgery and 1 an alternative endoscopic treatment.

Figure 2

Medication use at 3 mo after endocinch and at the end of follow-up. Presented as percentage of the baseline dose. Interquartile range (IQR) , range and median are shown; Median values were 31% and 97% for 3 mo and end of follow-up, respectively (^bP < 0.001, ^dP < 0.001, both compared with baseline).

Figure 3

Kaplan-Meier survival curves. Analysis of proportion of patients responding to Endocinch during follow-up; All treatment failures (i.e., > 50% of baseline acid-suppressive dose or other antireflux treatment) were included.