ORIGINAL ARTICLE

Gastroesophageal Reflux Management with the LINX® Systemfor Gastroesophageal Reflux Disease Following LaparoscopicSleeve Gastrectomy

Kenneth Desart1 & Georgios Rossidis1 & Michael Michel1 & Tamara Lux1 &

Kfir Ben-David2

Received: 22 May 2015 /Accepted: 29 June 2015# 2015 The Society for Surgery of the Alimentary Tract

AbstractBackground Laparoscopic sleeve gastrectomy (LSG) has gained significant popularity in the USA, and consequently resulted inpatients experiencing new-onset gastroesophageal reflux disease (GERD) following this bariatric procedure. Patients with GERDrefractory to medical therapy present a more challenging situation limiting the surgical options to further treat the de novo GERDsymptoms since the gastric fundus to perform a fundoplication is no longer an option.Objectives The aim of this study is to determine if the LINX® magnetic sphincter augmentation system is a safe and effectiveoption for patients with new gastroesophageal reflux disease following laparoscopic sleeve gastrectomy.Settings This study was conducted at the University Medical Center.Methods This is a retrospective review of seven consecutive patients who had a laparoscopic LINX® magnetic sphincter deviceplacement for patients with refractory gastroesophageal reflux disease after laparoscopic sleeve gastrectomy between July 2014and April 2015.Results All patients were noted to have self-reported greatly improved gastroesophageal reflux symptoms 2–4 weeks after theirprocedure. They were all noted to have statistically significant improved severity and frequency of their reflux, regurgitation,epigastric pain, sensation of fullness, dysphagia, and cough symptoms in their postoperative GERD symptoms compared withtheir preoperative evaluation.Conclusion This is the first reported pilot case series, illustrating that the LINX® device is a safe and effective option in patientswith de novo refractory gastroesophageal reflux disease after a laparoscopic sleeve gastrectomy despite appropriate weight loss.

Keywords Gastroesophageal reflux disease . Sleevegastrectomy . LINX® system

Introduction

Laparoscopic sleeve gastrectomy (LSG) has gained signifi-cant popularity in the USA, and in some reports has recently

surpassed Roux-en-Y gastric bypass (RYGB) as the mostcommonly performed weight loss surgery.1

–3 Both proceduresare highly effective weight loss tools and dramatically im-prove important obesity-related conditions including type IIdiabetes, hypertension, and obstructive sleep apnea.3 Gastro-esophageal reflux disease (GERD) is another condition highlyprevalent among the morbidly obese population. WhileRYGB is well documented to both improve GERD andlimit new-onset GERD, there is no consensus regardingthe relationship between LSG and GERD.4

–9 It is clear,however, that 18–22 % patients will experience new-onset GERD following LSG.8

,10 In the majority of thesepatients, proton pump inhibitors (PPIs) are effective incontrolling reflux symptoms.4 Those patients with GERDrefractory to PPIs present a more challenging situationlimiting the surgical options to further treat the de novoGERD symptoms. The traditional surgical method of

* Kfir Ben-DavidKfir.bendavid@msmc.com

1 Department of Surgery, University of Florida, Gainesville, FL, USA2 Mount Sinai Medical Center, Comprehensive Cancer Center, 4306

Alton Road, 2nd Floor, Miami Beach, FL 33140, USA

J Gastrointest SurgDOI 10.1007/s11605-015-2887-z

using the patient’s gastric fundus to perform afundoplication is no longer an option for these patientsand the treatment alternatives for patients experiencingGERD symptoms after LSG are few.

Most commonly, conversion of a sleeve gastrectomyto RYGB is undertaken and is highly effective in con-trolling reflux symptoms. Although this is a well-described option in the literature, the inherent risks asso-ciated with a repeat bariatric operation, and those factorsinfluencing the initial choice of LSG over RYGB stillremain. We sought to identify an alternative approachto the management of refractory GERD after LSG andrecognized an opportunity with the LINX® magneticsphincter device. The LINX® Reflux Management Sys-tem (Torax Medical, Inc., Shoreview, MN, USA) wasapproved for the treatment of GERD in March of 2012.The existing literature supports this device as a safe andeffective option for the treatment of medically refractoryGERD.11

–24 Hence, we present the first seven knowncases of LINX® device implantation for the managementof refractory GERD following LSG.

Methods

We performed a retrospective review of seven consecutivepatients who had a laparoscopic LINX® magnetic sphincterdevice placement for patients with refractory gastroesophage-al reflux disease after laparoscopic sleeve gastrectomy be-tween July 2014 and April 2015. The division’s databasewas interrogated after institutional review board approval,and the patient demographic characteristics, operative details,and postoperative outcomes were collected and analyzed. Theoperative procedure was completed by the same surgeon forall seven patients to avoid technical variability. We dissectedthe posterior vagus nerve from the esophagus and implantedthe device in a similar fashion as previously described in theliterature (Figs. 1 and 2).11

–24

All patients had a preoperative and postoperative uppergastrointestinal (UGI) study. All the radiographic swallowstudies were performed at the same facility using similar dy-namic techniques while performing maneuvers to elicit reflux.Similarly, the 24-h pH probe and esophageal manometry wereperformed as part of their GERD evaluation. They were allinterviewed regarding their reflux symptoms using the GERDscore questionnaire as we have previously reported.8 Allenet al. have previously validated this questionnaire.25 The pa-tients were specifically asked to score the severity and fre-quency of their reflux, regurgitation, epigastric pain, sensationof fullness, dysphagia, and cough symptoms. In addition, theywere also asked whether they were satisfied with their GERDsymptoms following the laparoscopic LINX® procedure.

Results

We identified seven patients from this time period who had alaparoscopic LINX® magnetic sphincter device placement forrefractory gastroesophageal reflux disease following their lap-aroscopic sleeve gastrectomy. Table 1 shows the patient de-mographic and surgical characteristics. Mean age was53 years, five were females, five were Caucasians, one His-panic, and one African-American. Refractory gastroesophage-al reflux was the dominating presenting symptom which wasnot present prior to their LSG. Mean body mass index (BMI)for the study cohorts was 50.7 kg/m2 (range 40–68.5 kg/m2)prior to their laparoscopic sleeve gastrectomy. The meanweight loss and change in BMI prior to their laparoscopicLINX® magnetic sphincter device placement was 42.7 kg(range 25–69.6 kg) and 15.3 kg/m2 (range 9.4–25.5 kg/m2),respectively. Themean andmedian period of time between thepatients’ LSG and implantation of the LINX® device was 18.1and 10.1 months, respectively (range 9–36 months). All

Fig. 1 Dissection of posterior vagus nerve

Fig. 2 Placementof LINX® device

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patients had a 24-h pH probe and esophageal manometrystudy indicating a mean DeMeester score of 56.6 and a hypo-tensive LES. One patient did not tolerate the placement ofesophageal probes; hence, both studies were aborted. An up-per Gastrograffin esophagogram study was performed preop-eratively and postoperatively illustrating gastroesophageal re-flux in the supine and upright position which completely re-solved following the placement of the LINX® magneticsphincter device. None of the patients had a hiatal hernia pres-ent on the preoperative esophagogram or intraoperativelywhile placing the LINX® magnetic sphincter device.

We evaluated all the patients’ reflux symptoms using theGERD score questionnaire 2–4 weeks after their surgical pro-cedure. All patients were noted to have self-reported greatlyimproved gastroesophageal reflux symptoms 2–4 weeks aftertheir procedure. They were all noted to have statistically sig-nificant improved severity and frequency of their reflux, re-gurgitation, epigastric pain, sensation of fullness, dysphagia,and cough symptoms in their postoperative GERD symptomscompared with their preoperative evaluation (P<0.05). Allparticipants were extremely happy with their surgery.

Discussion

Obesity is a significant risk factor for GERD,26 with preva-lence rates as high as 30% in the morbidly obese.27 In patientswith preexisting GERD, LSG improves symptoms of GERDin 2.8–20 %.10 RYGB, on the other hand, is a highly effectiveantireflux surgery and resolves GERD symptoms in70–80 %.28

,29 More troubling is development of new-onsetGERD following LSG, observed in as many as 8.6–22 % ofpatients.8

,30

In patients with reflux refractory tomedical therapy, limitedsurgical options exist since the LSG procedure involves re-moval of the fundus. As a result, fundoplication is extremelydifficult to perform with the limited amount of fundus tissue

present in patients with prior LSG. Consequently, the Roux-en-Y gastric bypass has been recommended as a conversionprocedure for those who develop or continue to have refluxafter LSG. Alternatively, the LINX® procedure can be con-sidered as another viable option that may potentially havefewer surgical complications compared to RYGB. Further-more, the LINX® device is implanted in the area of the gas-troesophageal junction which is largely undisturbed withLSG. This study is the first to evaluate the LINX® devicefor GERD in post-LSG patients.

The LINX® gained FDA approval in 2012. The initialInvestigational Device Exemption (IDE) feasibility trial en-rolled 44 patients between 2007and 2008 and follow-updata exists out to 4 years.12

,16 Esophageal pH normaliza-tion was demonstrated in 16 of 20 patients at 3 years.Based on the GERD-HRQL questionnaire, 87 % of pa-tients (20/23) reported satisfaction with their current con-dition at 4 years (measured off PPIs). Dysphagia was themost common adverse event, reported in 43 % (20/44) ofpatients. This symptom was noted immediately postopera-tively but decreased to <5 % at 1 year. Three patientshave undergone device explantation. The first required de-vice removal at 226 days after implantation secondary topersistent dysphagia, with symptom resolution after theexplant. A second elected for device removal at 3.5 yearssecondary to persistent GERD symptoms and underwentNissen fundoplication. The third patient to undergo deviceexplantation did so electively to have an MRI. No reportsof device erosion or migration have been reported in these44 patients.

The second IDE pivotal study was a prospective,nonrandomized clinical trial enrolling 100 patients for which3-year follow-up data has been reported.24 At 12 months, only64 % of patients met the primary efficacy endpoint of normali-zation of or at least a 50 % reduction in esophageal acid expo-sure. At 3 years, 94 % of patients reported satisfaction with theirreflux, and 87 % reported complete cessation of PPIs. Similar to

Table 1 Patient demographics

Patient Age Gender Initialweight(kg)

Currentweight(kg)

InitialBMI(kg/m2)

CurrentBMI(kg/m2)

Excessweight loss(%)

DeMeesterscore

Time of implant frominitial surgery(months)

PreoperativeGERD score

PostoperativeGERD score

1 53 Male 118 93 44.6 35.2 21.1 25.8 7 17 5

2 53 Male 142 103 47.4 34.4 27.5 123.9 9 17 5

3 53 Female 161 92 59.1 33.6 43.1 71.1 12 17 5

4 58 Male 134 89 39.9 26.6 33.3 N 24 17 5

5 36 Female 137 97 55 39.1 28.9 76 27 17 5

6 48 Male 176 126 68.5 49.1 28.4 25.7 12 17 5

7 52 Male 114 84 40.5 29.9 26.2 17 36 18 6

GERD score25: severity and frequency of their reflux, regurgitation, epigastric pain, sensation of fullness, dysphagia, and cough symptoms

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the feasibility trial, dysphagia was the Most common adverseevent and occurred in 68 % of patients. Six patients requireddevice removal; three for persistent dysphagia that resolved afterexplantation, one for intermittent vomiting that did not resolve,one for persistent reflux, and another for persistent chest pain. At2 years, there were no reports of device erosion or migration.

Traditionally, conversion to RYGB has been the procedureof choice in these patients. Although highly effective in con-trolling reflux symptoms, conversion to RYGB is a majoroperation with many known risks. Furthermore, some patientsare not candidates for this conversion due to unfavorable gas-trointestinal anatomy or issues with malabsorption. In the cur-rent pilot case series, we demonstrate that LINX® implanta-tion is a safe and effective option in patients with de novorefractory GERD after LSG despite appropriate weight loss.These patients did not have or developed a hiatal hernia as aresult of their LSG. Hence, we only included patients that hadde novo refractory gastroesophageal reflux without hiatal her-nia to minimize an additional variable in our pilot study.

All patients were very satisfied with their weight loss sincethe mean weight loss and BMI reduction was 42.7 kg and15.3 kg/m2, respectively at 18 months. All patients reportedimprovement in GERD symptoms and objective radiographicmeasurements demonstrated decreased esophageal acid expo-sure. Lastly, none of the patients were noted to have gastricpouch dilation as compared to their initial UGI study imme-diately following their bariatric sleeve gastrectomy procedure,and they did not have a hiatal hernia as a cause of their GERD.

We appreciate that this is a small series of patients to con-clude long-term results considering we did not perform a re-peat esophageal pH probe or manometry for our patients todetermine if the DeMeester score has changed. However, wecould not justify doing so based on the patients’ symptomsimprovement, cost and potential adverse event.

Furthermore, with the second IDE pivotal trial indicatingno reports of device erosion or migration at 2 years, we feltthat this would be a low-risk surgical treatment as compared tothe alternative more complex bariatric revision.24 In fact, theLINX® device can be easily explanted and does not precludeconversion to RYGB should this need arise. With the increas-ing incidence of new-onset GERD following LSG and limitedsurgical options, we firmly believe that a multicenter study isneeded to ensure the long-term safety and efficacy of theLINX® device in LSG population.

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