Use of an Endoscopic Suturing Device (the ”ESD”) to Treat Patients with Gastroesophageal Reflux Disease, After Unsuccessful EndoCinch Endoluminal Gastroplication: Another Failure

• Introduction
• Patients and Methods
• Patients
• Clinical Assessment
• Endoscopy and ESD Procedure
• 24-hour pH Monitoring
• Esophageal Manometry
• Statistical Analysis
• Results
• Clinical Assessment
• Endoscopy- and Procedure-Related Data
• Esophageal Manometry
• 24-hour pH Monitoring
• Adverse Events
• Discussion
• References

Background: Endoluminal gastroplication, using the EndoCinch procedure, has emerged as a potential endoscopic antireflux therapy. Although initial results have been promising, the long-term durability of the treatment is uncertain due to suture loss. A new endoscopic suturing device, the ”ESD,” has been developed that promises excellent visibility and endoscopic control. The aim of this study was to evaluate prospectively the feasibility and efficacy of the ESD method after EndoCinch failure.
Methods: The study involved 20 patients with gastroesophageal reflux disease (GERD), who had been initially treated with an EndoCinch procedure, but had relapsed after a median of 7.5 months, with lost or dysfunctional sutures and with reflux symptoms that required proton pump inhibitor (PPI) treatment. Using the ESD, at least three plications were created at the gastroesophageal junction. Patients underwent endoscopy, 24-hour pH monitoring and esophageal manometry before treatment and 6 months afterwards. In addition, reflux symptoms as well as quality-of-life scores were assessed (using the SF-6 and GERD-HRQL scales).
Results: The ESD procedure (median procedure time 45 min) was performed successfully in all patients without major complications. After 6 months only one patient (5 %) still had all sutures in situ, while no remaining sutures could be detected in 3/20 (15 %). No significant changes in reflux esophagitis; 24-hour pH monitoring results (median pH < 4/24 h9.9 % vs. 12.3 %; P = 0.60); manometry findings (median lower esophageal sphincter pressure 7.2 mm Hg vs. 9.9 mm Hg; P = 0.22); PPI use; or reflux esophagitis could be detected after 6 months. While reflux symptoms improved (heartburn severity score 30 vs. 48, P < 0,05), no changes in quality-of-life scores were detected.
Conclusions: Endoluminal gastroplication using the ESD is an easy and safe, but unfortunately ineffective procedure for endoscopic GERD treatment. Endoluminal gastroplication techniques clearly need refinements before these therapies can evolve as a treatment option for GERD patients.

Introduction

Gastroesophageal reflux disease (GERD) is a substantial medical and economic burden worldwide. In Western countries approximately 15 - 25 % of adults suffer reflux symptoms, in particular heartburn and/or regurgitation, requiring medication on a regular basis [1]. In addition, long-standing esophagitis may result in Barrett's metaplasia and esophageal adenocarcinoma [2] [3] [4].

To date, antisecretory medication or antireflux surgery are the established treatment options for GERD. Currently, proton pump inhibitors (PPIs) represent the gold standard for treatment of GERD [5] [6] [7] [8], but since PPIs do not restore the antireflux barrier, lifelong medication is required in most cases. Often, therefore, laparoscopic antireflux surgery is proposed as a definitive alternative [9]. Surgical treatment results in a positive long-term outcome in 80 % - 90 % of patients. However, antireflux surgery has been associated with a 5 % morbidity and a 0.3 % mortality at centers where there is experience with the procedures [9] [10] [11]. In addition, 10 years after antireflux surgery 62 % of patients still require regular PPI treatment [12].

In view of the limitations of PPIs and the potential risks of laparoscopic surgery, several endoscopic antireflux techniques have been developed. Currently three endoscopic suturing devices are available: the EndoCinch (BARD Endoscopic Technologies, Billerica, Massachusetts, USA), the ESD (Wilson-Cook Medical, Winston-Salem, North Carolina, USA), and the Full-Thickness Plicator (NDO Surgical Inc., Mansfield, Massachusetts, USA). So far, amongst these endoluminal suturing devices, the EndoCinch procedure is the one that has been tested on the largest scale. At 6 months after EndoCinch endoscopic suturing, modest but significant improvements in heartburn and regurgitation, as well as in medication use, were found in 64 patients [13]. In another open-label prospective trial, 62 % of the patients were in effect no longer using PPI medication (defined as having ≤ 4 doses/month) [14]. However, the procedure is difficult to perform and the long-term durability is poor due to loss of sutures or ineffective plication.

A new endoluminal suturing device, the ESD, was introduced in 2002. First reports described easy handling, excellent visibility during implantation, and short procedure times, but data on durability and clinical outcome are unavailable so far [15]. The aim, therefore, of this single-center prospective study was to evaluate the efficacy and safety of the ESD procedure after failed EndoCinch treatment, over a 6-month follow-up period.

Patients and Methods

Patients

Between February 2003 and February 2004, 20 GERD patients (6 women, 14 men; median age 46, range 22 - 68) underwent endoluminal gastroplication using the ESD, at a single center (the University of Leipzig). Prior to the ESD procedure, all these patients had been treated using the EndoCinch approach but had relapsed, with GERD symptoms and PPI dependency. Endoscopic inspection revealed complete or nearly complete suture loss after a median of 7.5 months (range 2 - 20 months).

Initially patients had required EndoCinch endoluminal gastroplication because of an incomplete response to antisecretory medication and/or a refusal of lifelong PPI medication. The inclusion criteria for the present study were: (a) symptoms of chronic heartburn and/or regurgitation (> 2 years); (b) dependence on continuous PPI medication; (c) pathological result from 24-hour pH monitoring (pH < 4/24 hgreater than 5.2 %; and DeMeester-Johnson score > 14.7); (d) age between 18 and 80 years. The exclusion criteria were: (a) presence of hiatal hernia > 3 cm in length; (b) grade IV reflux esophagitis; (c) histologically proven Barrett's mucosa; (d) severe dysphagia; (e) previous esophageal or gastric surgery; (f) specific motility disorders; and (g) significant untreated medical conditions.

The patients' clinical histories were assessed prior to the procedure and also the baseline characteristics of age, weight, and gastric acid-suppressive medical therapy (expressed as equivalents of the standard dose of omeprazole 20 mg taken per month). All patients gave their written informed consent and the protocol was approved by the local ethics committee.

Clinical Assessment

Clinical status and antisecretory medication use were assessed using a standardized GERD-related questionnaire, at baseline after 14 days without acid-suppressive medication and at 3 and 6 months after each procedure; heartburn, regurgitation, and dysphagia were scored [16]. The frequency of symptoms was classified according to the modified DeMeester symptom-scoring system [17]. A heartburn severity scoring system (HBSS) was applied as described elsewhere [13].

A clinically ”complete” response was defined as an elimination of PPI use or a reduction I use greater than or equal to 50 %, and a reduction in HBSS score. Nonresponders were defined as those patients whose reduction in PPI use was less than 50 % or who lacked improvement in HBSS score. All patients with incomplete response had been given escalating doses of PPIs.

In addition, all patients completed the validated GERD health-related quality-of-life (GERD-HRQL) scale [18] for disease-specific evaluation, and the SF-36 questionnaire [19] to assess patient satisfaction and general quality of life.

Endoscopy and ESD Procedure

Upper gastrointestinal endoscopy was performed before and 6 months after each endoscopic antireflux procedure in all patients, using a high resolution video endoscope (Olympus, Hamburg, Germany), prior to study entry. Grade of esophagitis and size of hiatal hernia, if present, were documented.

The ESD is a single-use endoscopically assisted endoluminal suturing device that has been approved by the US Food and Drug Adminstration (FDA) for soft-tissue apposition. We performed the procedure with the patients under sedation with midazolam and propofol. Briefly, for this procedure, the endoscope is inserted with the external accessory channel attached, and the operating site is determined. The ”Sew-Right” device is inserted into the external accessory channel and advanced until viewed endoscopically. Tissue is aspirated into the vacuum cap, and with suction being maintained, a lever is activated to deploy the needle to which the suture is attached. When the lever is released, the needle retracts, placing the suture. Suction is then discontinued, releasing the tissue. These steps are repeated for another suture placement, followed by the knot-tying process and the cutting of excess suture material. At least three plications were formed in each patient at the level of the gastroesophageal junction (Figure [1]).

24-hour pH Monitoring

Patients underwent pH monitoring after a 7-day suspension of antisecretory medication. After a 12-hour fast an ambulatory measurement of esophageal pH over a period of at least 20 hours was performed (Digitrapper; Medtronic Inc., Düsseldorf, Germany) according to the equipment manufacturer's instructions. This test was performed before each endoscopic antireflux procedure and 6 months after endoscopic suturing.

Esophageal Manometry

Esophagus manometry was performed transnasally with the patient in the supine position, by means of the stationary pull-through technique as described elsewhere [20], using a 8-channel low resistance constant perfusion system (Medtronic). The lower esophageal sphincter (LES) was considered incompetent if the resting pressure was <6 mm Hg and/or the intra-abdominal length was < 1 cm. Ten wet swallows were evaluated in order to assess esophageal peristaltic (tubular) function.

Statistical Analysis

Data were summarized by mean and standard deviation or median and interquartile range (IQR) for continuous variables and by frequency counts for categorical variables.

The nonparametric Wilcoxon signed-rank test was used to test the significance of changes in pH monitoring and manometry data, in PPI use, and in HBSS score, measured before and after the procedure. P values < 0.05 were considered to be significant.

Results

Clinical Assessment

Previously the EndoCinch procedure had been successfully completed in all 20 patients studied. Patients relapsed with typical symptoms within 7.5 months (range 2-20 months). The time from symptom relapse until the ESD procedure varied from 6.6 to 37.4 months (median 13.9 months). At the time of relapse following the EndoCinch procedure, there was no difference between the pre- and postprocedure daily medication use (P > 0.05) or HBSS scores (Figure [2], P > 0.05). According to the combined end point (drop in medication dosage of more than 50 %, and improvement in HBSS score), all patients had to be judged to be nonresponders.

After a second evaluation all patients underwent a successful ESD procedure. However, although at 3 months after the ESD procedure, 14/20 patients (70 %) showed at least a 50 % drop in PPI medication and 7/20 (40 %) of the patients took fewer than 10 doses/month, at 6 months after the ESD procedure all patients were PPI-dependent and only 2/20 (10 %) took fewer than 10 doses/month (Figure [3]). Heartburn symptoms as measured using the HBSS had improved significantly at 3 months (median 16, range 0 - 65) compared with baseline (median 48, range 22 - 84). Although HBSS scores were found to have increased again after 6 months (median 30, range 5 - 65), reflux symptoms were still significantly improved compared with baseline (P = 0.003) (Figure [2]). However, only 5/20 patients (25 %) could be assigned to the successfully treated group (responders) after 6 months.

Treatment with the ESD did not improve general quality-of-life scores, as measured on SF-36 subscales, except with regard to the emotional component. The GERD-specific quality-of-life score (GERD-HRQL) also failed to show any change (Figure [4]): 10/20 (50 %) patients experienced an improvement in heartburn scores (questions 1 - 9) as well as in regurgitation scores (questions 10 - 13), but the changes were not statistically significant (heartburn, P = 0.45; regurgitation, P = 0.06).

Endoscopy- and Procedure-Related Data

Before the ESD procedure, endoscopy had revealed nonerosive esophagitis in 1/20 patients (5 %), grade I esophagitis in 12/20 (60 %), and grade II in 7/20 (35 %), compared, at 6 months after the procedure, with nonerosive esophagitis in 3/20 (15 %), grade I in 13/20 patients (65 %), grade II in 3/20 (15 %), and grade III in 1/20 (5 %) (P > 0.05) (Table [1]).

Overall, a total of 65 sutures were placed, with five patients having four sutures and 15 patients having three sutures. At 6 months after ESD treatment, no suture could be detected in 3/20 patients (15 %), two sutures had vanished in 10/20 patients (50 %), and in 6/20 (30 %) at least one suture had gone. Only in 1/20 patients (5 %) were all sutures found to be in the same position as recorded at implantation (Figure [5]). However, no sutures forming plications in any patient were judged to be effective due to tearing of one stitch.

The average (median) procedure time, defined as the time from endoscope insertion to removal, was 57 minutes (range 40 - 100) for the EndoCinch procedure and 45 minutes (range 25 - 95) for the ESD procedure (P = 0.02), while more plications per patient were created using the ESD (EndoCinch 2.8 plications, ESD 3.3 plications; P = 0.02).

Esophageal Manometry

Incompetence of the LES (< 6 mmHg) was found in 10/20 patients (50 %) prior to the ESD procedure. Manometric studies revealed no significant differences pre- and post-ESD procedure in either LES pressure (P = 0.22) or length (P = 0.86) (Table [1]). No differences in esophageal motor function of the tubular esophagus were observed in the repeated studies (P = 0.51). Ineffective esophageal motility was recorded in 6/20 (30 %) patients both before and after the ESD treatment.

24-hour pH Monitoring

A comparison of 24-hour pH studies before vs. after ESD treatment showed no significant improvement at 6-month follow-up (Table [1]), with a DeMeester-Johnson pre-procedure score of 64.0 (33.1-78.6) compared with 47.1 (26.0 - 89.6) post-procedure (P = 0.54), and cumulative reflux time pH < 4/24 hvalues being 9.9 (7.8 - 22.0) before treatment and 12.3 (9.0 - 25.7 (P = 0.60) after treatment. The number of reflux episodes was also not reduced (P = 0.82).

Adverse Events

The incidence of reported device-related adverse events was low and none of these was considered clinically serious. No perforations, bleeding episodes requiring transfusion, or other severe adverse events were recorded. During the ESD procedure 2/20 (10 %) patients had a brief bleeding episode that required no further treatment.

Transient chest pains, nausea, or abdominal pains were reported by 17/20 patients (85 %) after the procedure. Complications arising after the ESD procedure resolved within 1 week without treatment in all cases.

Discussion

This prospective study of endoluminal gastroplication using an endoscopic suturing device, the ”ESD”, after EndoCinch failure demonstrates that the ESD procedure is not superior with regard to efficacy and long-term durability for the management of patients with GERD. The method is safe and improves the handling of endoluminal suturing, thus resulting in a shorter procedure time compared with that of EndoCinch. However, none of the patients was able to discontinue PPIs entirely and only 2/20 (10 %) needed fewer than 10 doses/month. Furthermore, no significant improvements in the results for manometry, 24-hour pH monitoring, or quality of life (SF 36, GERD-HRQL) were observed during a 6-month follow-up. Heartburn patients had lower scores than the general population in all dimensions except the emotional one, which supports data derived from large surveys [21] [22]. However, significant improvement in subjective heartburn scores (according to the HBSS) was maintained during the follow-up period. These findings would suggest that ESD treatment cannot compete with medical or surgical therapy, as judged by objective parameters, and needs technical refinements before further use in patients.

Although current medical (PPI) and surgical (laparoscopic fundoplication) GERD therapies achieve high response rates in relieving symptoms, both approaches have disadvantages and potential hazards [5] [6] [7] [8] [9] [10] [11] [23]. Therefore, new endoscopic antireflux therapies (EATs) have been developed during the past few years (and have been approved by the US Food and Drug Administration (FDA)). Although initial results showed high efficacies for all the techniques, sham-controlled trials demonstrated only limited success [24] [25].

Despite potential treatment advantages (e. g. less invasiveness, shorter hospital stay), the effectiveness, durability, and safety of EAT devices need to be demonstrated in clinical trials. In the present ESD study, patients were included who had relapsed, with typical reflux symptoms, after an EndoCinch procedure. Good short-term results have been reported for EndoCinch treatment, demonstrating an effectiveness of up to 60 % (reduction in HBSS score and a drop in antisecretory medication doses of more than 50 %) in studies up to 6 months after the procedure [13] [14]. However, long-term data are disappointing, showing treatment failures of 80 % at 18 months after therapy [26] [27]. However, after a 6-month follow-up in the present study we could not detect any significant effect on objective measures following ESD treatment after EndoCinch failure. There was no improvement in distal esophageal acid exposure (pH < 4/24 h), DeMeester-Johnson score, or LES pressure (Table [1]). After 6 months the majority of patients remained dependent on PPIs. None could discontinue PPIs completely, and only 5/20 (25 %) were able to reduce PPI intake by 50 % or more. Nine of those patients with improvements in clinical and objective parameters also showed retention of some sutures, thereby demonstrating the potential of effective EAT.

These negative results for objective response parameters contrast with a significant reduction in heartburn symptoms (the median 6-month HBSS score being 30, compared with 48 at baseline). A possible explanation is a high ”placebo/sham” effect, as demonstrated in sham-controlled studies of endoscopic antireflux procedures [24] [25]. The EndoCinch and the ESD procedures are safe and well tolerated by patients. No treatment-related deaths were encountered. All minor complications (minor bleeding in 10 % with the ESD procedure) and discomfort (pharyngeal pain in 65 % with the ESD) were self-limiting; there were no long-term complications for either procedure. Initial experience with the ESD had shown better control of the implantation site and suture depth due to superior visibility, with the potential result of improved durability [15]. In contrast, our results demonstrate a disappointing success rate of 5/20 (25 %) after 6 months. Therefore, in terms of clinical benefit the ESD procedure is clearly not superior to its EndoCinch counterpart.

The loss of sutures is probably the key issue with regard to the disappointing long-term response rates after endoluminal suturing. Although one 12-month follow-up study [14] reported suture loss in only 5/22 patients, other reports suggest a substantial long-term rate of suture loss. According to animal studies [28], the success rate is limited by shallow suturing, reaching only the deep submucosa in most cases, without fusion between folds. Therefore, further development of the device, that is, enlargement of the suction chamber, or procedure modification such as fold fusion by coagulation, are warranted [29].

In conclusion, the endoscopic suturing technique using the ESD is safe and easy to perform. However, treatment of GERD patients using the ESD was not associated with a substantial reduction in PPI use or improvement in objective parameters, although subjective heartburn symptoms were ameliorated. Therefore, as a treatment for GERD, endoluminal suturing clearly needs technical refinement to ensure durability and long-term efficacy, to maximize clinical benefit for selected patients.

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K. Caca, M. D.

Department of Medicine II, University of Leipzig

Philipp-Rosenthal Str. 27 · 04103 Leipzig · Germany

Fax: +49-341-9712239

Email: caca@medizin.uni-leipzig.de

References

• 1 Nebel O T, Fornes M F, Castell D O. Symptomatic gastroesophageal reflux: incidence and precipitating factors.  Am J Dig Dis. 1976;  21 953-956
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• 2 Klauser A G, Schindlbeck N E, Muller-Lissner S A. Symptoms in gastro-oesophageal reflux disease.  Lancet. 1990;  335 205-208
  CrossrefPubMedSearch in Google Scholar
• 3 Dimenas E, Glise H, Hallerback B. et al . Quality of life in patients with upper gastrointestinal symptoms. An improved evaluation of treatment regimens?.  Scand J Gastroenterol. 1993;  28 681-687
  PubMedSearch in Google Scholar
• 4 Locke G R 3rd, Talley N J, Fett S L. et al . Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota.  Gastroenterology. 1997;  112 1448-1456
  CrossrefPubMedSearch in Google Scholar
• 5 Vigneri S, Termini R, Leandro G. et al . A comparison of five maintenance therapies for reflux esophagitis.  N Engl J Med. 1995;  333 1106-1110
  CrossrefPubMedSearch in Google Scholar
• 6 Klinkenberg-Knol E C, Nelis F, Dent J. et al . Long-term omeprazole treatment in resistant gastroesophageal reflux disease: efficacy, safety, and influence on gastric mucosa.  Gastroenterology. 2000;  118 661-669
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  CrossrefPubMedSearch in Google Scholar
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K. Caca, M. D.

Department of Medicine II, University of Leipzig

Philipp-Rosenthal Str. 27 · 04103 Leipzig · Germany

Fax: +49-341-9712239

Email: caca@medizin.uni-leipzig.de