Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux

Ganz, Robert A.; Edmundowicz, Steven A.; Taiganides, Paul A.; Lipham, John C.; Smith, C. Daniel; DeVault, Kenneth R.; Horgan, Santiago; Jacobsen, Garth R.; Luketich, James D.; Smith, Christopher; Schlack-Haerer, Steven; Kothari, Shanu N.; Dunst, Christy M.; Watson, Thomas J.; Peters, Jeffrey H.; Oelschlager, Brant K.; Perry, Kyle A.; Melvin, Scott; Bemelman, Willem A.; Smout, A. J. P. M.; Dunn, Dan

doi:10.1016/j.cgh.2015.05.028

Cited by 175 publications

(133 citation statements)

References 36 publications

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“…Both revisional operations were performed without difficulty, confirming previous reports on the safety and feasibility of laparoscopic anti-reflux surgery after TF [25]. Recently, a study discussing another more invasive anti-reflux procedure purported that the rate of reoperation following TF could range from 11.5 to 52.6 % [26], citing reports from Europe where earlier iterations of the device and technique had been used [27–30] in a suboptimally selected patient population which included large hiatal hernias and Hill grade III and IV. In contrast, in the TEMPO trial and other recent randomized controlled TF trials [12–15], all patients received a standardized TF 2.0 procedure with a rotational component, as described by Bell and Cadière [11].…”

Section: Discussionsupporting

confidence: 77%

Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm

et al. 2016

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BackgroundFour randomized controlled trials have demonstrated the short-term efficacy and safety of transoral esophagogastric fundoplication (TF) performed with the EsophyX® device in eliminating troublesome gastroesophageal reflux disease (GERD) symptoms in well-selected patient populations. The aim of this study was to assess the durability of these outcomes at 3 years post-procedure.MethodsThe TF EsophyX versus Medical PPI Open Label trial was conducted in seven US sites. Between June and August 2012, we enrolled patients with small (<2 cm) or absent hiatal hernias who suffered from troublesome GERD symptoms while on PPI therapy for at least 6 months and had abnormal esophageal acid exposure (EAE). Randomization was to TF group (n = 40) or to PPI group (n = 23). Following evaluation at 6 months, all remaining PPI patients (n = 21) elected to undergo crossover to TF. Fifty-two patients were assessed at 3 years for (1) GERD symptom resolution using three GERD-specific quality of life questionnaires, (2) healing of esophagitis using endoscopy, (3) EAE using 48-h Bravo testing, and (4) discontinuation of PPI use. Two patients who underwent revisional procedures by year 3 were included in the final analysis.ResultsAt 3-year follow-up, elimination of troublesome regurgitation and all atypical symptoms was reported by 90 % (37/41) and 88 % (42/48) of patients, respectively. The mean Reflux Symptom Index score improved from 22.2 (9.2) on PPIs at screening to 4 (7.1) off PPIs 3 years post-TF, p < 0.0001. The mean total % time pH <4 improved from 10.5 (3.5) to 7.8 (5.7), p = 0.0283. Esophagitis was healed in 86 % (19/22) of patients. At the end of study, 71 % (37/52) of patients had discontinued PPI therapy. All outcome measures remained stable between 1-, 2-, and 3-year follow-ups.ConclusionThis study demonstrates that TF can be used to achieve long-term control of chronic GERD symptoms, healing of esophagitis, and improvement in EAE.

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Section: Discussionsupporting

confidence: 77%

Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm

et al. 2016

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“…34 In the only study that reported healing of esophagitis, Ganz et al found healing of esophagitis in 76.5% of patients at 5 years. 38 Complete cessation of all PPI use was achieved in 71.4–85.3%, with 75.3% of patients reporting complete cessation and 9.4% reporting on demand PPI use at longest follow-up of 5 years. 34–38 …”

Section: Resultsmentioning

confidence: 90%

“…38 Complete cessation of all PPI use was achieved in 71.4–85.3%, with 75.3% of patients reporting complete cessation and 9.4% reporting on demand PPI use at longest follow-up of 5 years. 34–38 …”

Section: Resultsmentioning

confidence: 90%

“…34–38 Symptom response as measured by median GERD-HRQL significantly improved in all studies decreasing from 24–29 at baseline off PPI to 3.3–6 post-treatment. 34–38 Bonavina et al found MSA significantly reduced EAE, normalized or reduced acid exposure by >50% in 80% of patients, reduced baseline DeMeester Score, and decreased total reflux episodes at median follow-up time of 4.2 years. 35 Lipham et al likewise found a reduction in EAE, normalization of pH in 80% of patients, and a reduction in DeMeester score at median follow-up time 3.7 years; though the reduction in reflux episodes was non-significant.…”

Section: Resultsmentioning

confidence: 90%

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Review of antireflux procedures for proton pump inhibitor nonresponsive gastroesophageal reflux disease

Hillman

Yadlapati

Whitsett

et al. 2017

Diseases of the Esophagus

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Introduction Up to 40% of patients with gastroesophageal reflux disease (GERD) report persistent symptoms despite proton pump inhibitor (PPI) therapy. This review outlines the evidence for surgical and endoscopic therapies for the treatment of PPI non-responsive GERD. Material and Methods A literature search for GERD therapies from 2005–2015 in PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews identified unique 2928 citations. Of those, 45 unique articles specific to surgical and endoscopic therapies for PPI non-responsive GERD were reviewed. Results Laparoscopic fundoplication (n=19) provides symptomatic and physiologic relief out to 10 years, though efficacy wanes with time. Magnetic sphincter augmentation (n=6) and transoral incisionless fundoplication (n=9) improve symptoms in PPI non-responders, and may offer fewer side effects than fundoplication, though long-term follow-up is lacking. Radiofrequency energy delivery (n=8) has insufficient evidence for routine use in treating PPI non-responsive GERD. Electrical stimulator implantation (n=1) and endoscopic mucosal surgery (n=2) are emerging therapies for the treatment of GERD. Discussion Laparoscopic fundoplication remains the most proven therapeutic approach. Newer anti-reflux procedures such as magnetic sphincter augmentation and transoral incisionless fundoplication offer alternatives with varying degrees of success, durability, and side effect profiles that may better suit individual patients. Larger head-to-head comparison trials are needed to better characterize the difference in symptom response and side effect profiles.

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“…A single-center study [21] and a multicenter single-arm study, [22] enrolling 100 patients each, evaluated the long-term results of magnetic augmentation and showed that the procedure provides significant and sustained control of reflux with minimal side-effects or complications up to 6 years of follow-up. However, no randomized trials exist that can validate the effectiveness of the LINX and reliably compare its results with other established surgical therapies.…”

Section: Discussionmentioning

confidence: 99%

Longitudinal comparison of quality of life in patients undergoing laparoscopic Toupet fundoplication versus magnetic sphincter augmentation

et al. 2016

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Only a minority of patients with gastro-esophageal reflux disease (GERD) are offered a surgical option. This is mostly due to the fear of potential side effects, the variable success rate, and the extreme alteration of gastric anatomy with the current gold standard, the laparoscopic Nissen fundoplication. It has been reported that laparoscopic Toupet fundoplication (LTF) and laparoscopic sphincter augmentation using a magnetic device (LINX) can treat reflux more physiologically and with a lower incidence of side-effects and reoperation rate. We present the first comparing quality of life in patients undergoing LTF versus LINX.Observational cohort study. Consecutive patients undergoing LTF or LINX over the same time period were compared by using the propensity score full matching method and generalized estimating equation. Criteria of exclusion were >3 cm hiatal hernia, grade C–D esophagitis, ineffective esophageal motility, body mass index >35, and previous upper abdominal surgery. The primary study outcome was quality of life measured with the Gastro-Esophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire. Secondary outcomes were proton pump inhibitors (PPI) use, presence of gas-related symptoms or dysphagia, and reoperation-free probability.Between March 2007 and July 2014, 238 patients with GERD met the criteria of inclusion in the study. Of these, 103 underwent an LTF and 135 a LINX procedure. All patients had a minimum 1-year follow-up. Over time, patients in both groups had similar GERD-HRQL scores (odds ratio [OR] 1.04, confidence interval [CI] 0.89–1.27; P = 0.578), PPI use (OR 1.18, CI 0.81–1.70; P = 0.388), gas-related symptoms (OR 0.69, CI 0.21–2.28; P = 0.542), dysphagia (OR 0.62, CI 0.26–1.30; P = 0.241), and reoperation-free probability (stratified log-rank test = 0.556).In 2 concurrent cohorts of patients with early stage GERD undergoing LTF or LINX and matched by propensity score analysis, health-related quality of life significantly improved and GERD-HRQL scores had a similar decreasing trend over time up to 7 years of follow-up. We conclude that LTF and LINX provide similar disease-specific quality of life over time in patients with early stage GERD.

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Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux

Cited by 175 publications

References 36 publications

Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm

Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm

Review of antireflux procedures for proton pump inhibitor nonresponsive gastroesophageal reflux disease

Longitudinal comparison of quality of life in patients undergoing laparoscopic Toupet fundoplication versus magnetic sphincter augmentation

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