Ablation (RFA) and Anti-Reflux MucoSectomy (ARMS) for Gastroesophageal Reflux Disease

Fig. 24.1

Endoscopy after Stretta procedure showing the thermal effect on the lower esophageal tissue. (Images courtesy of Steven Edmundowicz, MD)

Corley et al. evaluated patients with both symptoms of GERD and pathologic esophageal acid exposure randomized to either RFA (n = 35) or sham therapy (n = 29). They showed improvement in daily heartburn symptoms between RFA and sham (61% v 33%, p = 0.005), and a > 50% improvement in GERD quality of life score (61% v 30%, p = 0.03). However, at 6 months there was no difference seen in daily medication use after a medication withdrawal protocol (55% v 61%, p = 0.67) and no difference in esophageal acid exposure [12].

The second randomized trial performed by Aziz et al. included patients that had 6 months of heartburn and a GERD health-related quality of life (GERD-HRQL) score of >18 when all medications (excluding antacids) were stopped for 10 days. The first arm was a single Stretta procedure, the 2nd arm was a “sham” procedure where patients underwent sedated endoscopy and the Stretta catheter was placed but no energy was delivered, and the third arm received the Stretta procedure, but in those who did not have a 75% improvement in GERD-HRQL scoring, then a repeat Stretta procedure was performed. The primary endpoint was improvement in GERD-HRQL from baseline. The study revealed that GERD-HRQL improved in the sham and treatment arm comparing pre- and post endoscopy scores. The degree of GERD-HRQL improvement was greater in the treatment group compared to the sham group, but this finding was not significant. Acid exposure time for the sham procedure group was not significant pre and post (9.9 min +/− 2.6 to 8.2 ± 3.1, p > 0.05) although it was reduced for both the single Stretta (9.4 min +/− 3.4 to 6.7 ± 2.8, p < 0.01) and double Stretta procedure groups (8.8 min +/− 2.8 to 5.2 ± 2.4, p < 0.01). Mean lower esophageal sphincter pressure at 12 months was also significantly increased in both single (11.6 ± 3.2 to 16.2 ± 4.5 mmHg, p < 0.01) and double treatment (12.2 ± 3.7 to 19.6 ± 2.9 mmHg, p < 0.01) arms compared to sham (14.1 ± 2.6 to 15.9 ± 3.2 mmHg, p > 0.05) [13].

Arts et al. looked at 22 GERD patients with a complete or partial response to high dose PPI therapy with long-standing history of established GERD with typical symptoms and pathological esophageal pH monitoring (>4% of time pH < 4) in a double-blind, sham-controlled, crossover radiofrequency trial [11]. These patients all had symptom assessment, endoscopy, manometry, 24-h esophageal pH monitoring, and a distensibility test of the GEJ completed prior to the study and after 3 months. In the first group of 11 patients that underwent Stretta therapy first followed by sham, they had a significant decrease in symptom scores (14.7 ± 1.5 v 8.3 ± 1.9, p < 0.005), but at 3 months when they underwent the sham procedure as part of the crossover, there was no additional significant difference observed (7.8 ± 2.1). In the second group who underwent sham therapy first, their symptoms did not improve significantly (16.1 ± 2.5 v 15.6 ± 2.2), but at 3 months when they underwent the Stretta procedure, there was a significant difference seen (7.2 ± 1.6, p < 0.05). At follow-up endoscopy at 3 and 6 months post Stretta procedure, there was no difference seen in number of patients with erosive esophagitis or the grade of esophagitis in comparison to pre-Stretta therapy. At 3 and 6 months, there was no difference observed in pathologic esophageal acid exposure or proton pump inhibitor used pre- and post Stretta procedure in either group. There was no significant difference seen in lower esophageal pressure, esophageal distensibility, or esophageal motility in the two groups prior to Stretta and at 3 and 6 months post procedure. This study did show a decrease in compliance at the gastroesophageal junction after the Stretta procedure (17.8 ± 3.6 v 7.4 ± 3.4 ml/mm Hg, p < 0.05) which reversed to pre-Stretta levels with administration of Sildenafil 50 mg, a smooth muscle relaxant which argues against fibrosis as the etiology of improvement of symptom scores as discussed earlier [11].

Coron et al. describe their experience in 43 patients in a randomized controlled trial comparing Stretta and proton pump inhibitor therapy [14]. All patients were using PPI therapy prior to the study. Primary endpoint evaluated at 6 months was the ability to stop or decrease PPI therapy to <50% of the effective dose required at baseline. At 6 months there was a significant improvement in patients that could either stop PPI therapy or reduce dose to <50% in favor of Stretta therapy (78% v 40%, p = 0.01), but this did not hold true at 12 months (56% v 35%, p = 0.16). HRQL scores were not different between groups, and there was no significant change in regard to esophageal acid exposure between baseline and 6 months after Stretta therapy [14].

Randomized controlled trials showing efficacy of the Stretta procedure are limited. There have been systemic reviews that have shown improvement in heartburn and GERD-HRQL scores. In one systematic review that included 20 articles (2 randomized controlled trial, 18 cohort studies) and 1441 patients in total, GERD symptoms and patient satisfaction based on mean Likert scores improved significantly (1.43 ± 4.1 to 4.07 ± 3.1, p = 0.0006) as well as GERD-HRQL scores (26.11 ± 27.2 to 9.25 ± 23.7, p = 0.0001). In this same analysis, DeMeester scores improved significantly (44.37 ± 93 to 28.53 ± 33.4, p = 0.0074) as well as esophageal acid exposure time (10.29% ± 17.8% to 6.51% ± 12.5%, p = 0.0003) [15].

A more recent meta-analysis performed by Lipka et al. with 165 patients, which only included randomized controlled trials of Stretta in comparison with either sham procedure [3] or PPI therapy [1], showed no difference between Stretta and sham therapies in regard to esophageal pH values (mean difference 1.56; 95% CI, −2.56 to 5.69; p = 0.46), augmentation of lower esophageal sphincter pressure (−0.3; 95% CI, −2.66 to 2.02; P = 0.79), HRQL score (−5.24; 95% CI, −12.95 to 2.46; P = 0.18), or the ability to stop the use of proton pump inhibitors (relative risk 0.87; 95% CI, 0.75–1.00; P = 0.06) [16].

Adverse events encountered with Stretta are usually mild and can include chest pain (50%), transient fever, and esophageal ulcers. Gastroparesis has been reported which has been thought to be due to inadvertent vagal nerve injury [4, 7]. Radiofrequency ablation therapy (Stretta) is currently lacking stringent long-term objective data, and it is difficult to recommend at this time based on this available data.

Anti-reflux Mucosectomy (ARMS )

In 2003, Satodate et al. reported a case of circumferential mucosal resection of the distal esophagus and gastric cardia for treatment of high-grade dysplasia in a patient with Barrett’s esophagus [17]. The patient prior to resection had a DeMeester score of 5 with a significant hiatal hernia (flap valve grade 3). Resection included 2 cm of the gastric cardia to ensure adequate margins. On follow-up, the patient was noted to form a scar at the level of the gastric cardia and had subsequent normalization of acid exposure on 24-h pH monitoring [18]. The patient did require multiple balloon dilations for initial stricture formation, but he remained asymptomatic from a GERD standpoint. This patient prompted Professor Inoue and the Tokyo group to investigate whether mucosectomy for GERD in the absence of a hiatus hernia was feasible for treatment of refractory GERD.

Inoue et al. selected PPI refractory GERD patients without a sliding hiatal hernia in the presence or absence of Barrett’s esophagus at their institution in Japan for study inclusion [19]. To evaluate the severity of GERD symptoms, the DeMeester score was applied [20]. Upper endoscopy was performed to evaluate the size and grade of any hiatal hernia and presence of esophagitis and/or Barrett’s (Fig. 24.2). All patients also underwent esophageal testing with manometry, 24-h pH monitoring and Bilitec. Gastroesophageal flap valve grading (grade 1–4) was used to describe the size and grade of any hiatal hernia [21].