Impact of sleeve gastrectomy on gastroesophageal reflux disease in a morbidly obese population undergoing bariatric surgery

Impact of sleeve gastrectomy on gastroesophageal reflux disease in a morbidly obese population undergoing bariatric surgery

Author's Accepted Manuscript Impact of Sleeve Gastrectomy on Gastroesophageal Reflux Disease in a Morbidly Obese Population Undergoing Bariatric Surg...

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Impact of Sleeve Gastrectomy on Gastroesophageal Reflux Disease in a Morbidly Obese Population Undergoing Bariatric Surgery LéShon Hendricks MD, Emanuela Alvarenga MD, Nisha Dhanabalsamy MD, Emanuele Lo Menzo MD, PhD, FACS, Samuel Szomstein MD, FACS, Raul Rosenthal MD, FACS www.journals.elsevier.com/surgery-for-obesity-and-related-diseases/

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S1550-7289(15)00814-X http://dx.doi.org/10.1016/j.soard.2015.08.507 SOARD2387

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Surgery for Obesity and Related Diseases

Cite this article as: LéShon Hendricks MD, Emanuela Alvarenga MD, Nisha Dhanabalsamy MD, Emanuele Lo Menzo MD, PhD, FACS, Samuel Szomstein MD, FACS, Raul Rosenthal MD, FACS, Impact of Sleeve Gastrectomy on Gastroesophageal Reflux Disease in a Morbidly Obese Population Undergoing Bariatric Surgery, Surgery for Obesity and Related Diseases, http://dx.doi.org/10.1016/j.soard.2015.08.507 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

Impact of Sleeve Gastrectomy on Gastroesophageal Reflux Disease in a Morbidly Obese Population Undergoing Bariatric Surgery. LéShon Hendricks, MD; Emanuela Alvarenga, MD; Nisha Dhanabalsamy, MD; Emanuele Lo Menzo, MD, PhD FACS; Samuel Szomstein, MD, FACS; Raul Rosenthal, MD, FACS The Bariatric & Metabolic Institute, Section of Minimally Invasive Surgery, Department of General Surgery, Cleveland Clinic Florida, Weston, Florida Correspondence: Raul J. Rosenthal, MD Chairman, Department of General Surgery Director of the Bariatric and Metabolic Institute Cleveland Clinic Florida 2950 Cleveland Clinic Blvd. Weston, Florida 33331 Phone 954 659 5000 Fax 954 659 5256 E-mail [email protected]

Impact of Sleeve Gastrectomy on Gastroesophageal Reflux Disease in a Morbidly Obese Population Undergoing Bariatric Surgery Abstract Background Laparoscopic sleeve gastrectomy (LSG) has established popularity as a weight loss procedure based on its success. However, the effect on gastroesophageal reflux disease (GERD) is unknown.

Objectives To analyze the incidence of GERD after LSG and to compare the results in patients with preexisting and de novo GERD. Setting Medical Center, United States; Clinic and Hospital Methods Authors performed a retrospective review of primary LSG from 2005-2013 and compared patients that underwent LSG with preexisting and de novo GERD. Results A total of 919 patients underwent LSG. GERD was present in 38 (4%) of the LSG cohort. We identified two groups: Group A consisted of 25 (3%) with de novo GERD and Group B consisted of 13 (1%) with pre-existing GERD. Diagnosis of GERD in both groups was derived by symptoms and history of proton pump inhibitor (PPI) treatment and/ or upper gastrointestinal endoscopy (UGI), esophagogastroduodenoscopy (EGD), and pH manometry. In Group A, 1 (4%) was managed with over-the-counter drugs, 17 (68%) were treated with low dose PPI, 6 (24%) treated with high dose PPI, and 1 (4%) was lost to follow-up. Group B consisted of 9 (69%) treated with low-dose PPI and 4 (31%) with high-dose PPI. A total of 4

patients (10.5%) failed medical treatment and required conversion to laparoscopic Roux-en-Y gastric bypass (LRYGB). In Group A, 1 patient (4%) required LRYGB and in Group B, 3 patients (23%) required LRYGB. The outcome of conversion for Group A was incomplete resolution of symptoms in the one patient, whereas in Group B, 3 patients (100%) had complete resolution of GERD symptoms after LRYGB.

Conclusion In this study, 3% developed de novo GERD, but most responded to either low- or high-dose PPI, with 4% requiring conversion to LRYGB. Keywords: Sleeve, Gastrectomy, GERD, Gastroesophageal, Reflux Introduction: The prevalence of obesity (body mass index [BMI] ≥ 35 kg/m²) has constantly increased in recent years and has already been compared to epidemics of past centuries (1). At present, obesity is one of the most chronic diseases, with a reduced quality of life and a high risk for morbidity and mortality (2, 3). Surgical weight reduction is considered the most durable option for the treatment of obesity and its comorbidities (4). Laparoscopic sleeve gastrectomy (LSG) has established popularity as a single, definitive procedure for weight loss based on its success, ease of technique, and low complication profile. It also appears safe in the longer term, with lower risk of adverse nutritional consequences and surgical complications (like marginal ulceration and internal hernia) (5). Prior studies have demonstrated that LSG is associated with significant weight loss and improvement of most comorbidities (6, 7, 8). However, the effect of LSG on GERD is unknown, and some studies have proposed that anatomical changes associated with LSG may increase

GERD symptoms or develop a de novo GERD (6, 7, 8). A systematic review of effect of LSG on GERD by Chiu et al. examined 15 studies that included GERD as either a primary or secondary outcome measure after LSG (9). Of these studies, four found an increased prevalence of GERD after LSG, and seven showed reduced prevalence of GERD after LSG. Authors rightly mentioned that it would be difficult to draw a definite conclusion from these data (10). These studies have raised concern and debate about the effect of LSG on GERD and whether GERD may even be a contraindication to LSG. The purpose of this study was to analyze the demographics, outcomes, and complication rates among a single institution cohort that underwent LSG for morbid obesity. We evaluated the development, resolution, management, and persistence of GERD in bariatric patients who underwent LSG and compared these results between patients who developed de novo GERD and had preexisting GERD. Methods: We performed a retrospective review of the primary LSG cases performed at our institution from 2005 to 2013. Local institutional review board (IRB) review and authorization were obtained for this study. This study was performed using retrospective data obtained from patient electronic charts. All patients who underwent LSG at the institution between 2005 and 2013 were reviewed. All the candidates for LSG undergo EGD. If the EGD is not covered by insurance or there are concerns regarding high-risk airway anatomy, then we obtain an UGI study instead. Recently, we have been recommending preoperative pH studies for moderate to severe GERD patients who insist on having LSG.

All original LSG procedures were performed by the same group with a standardized technique. The distance from the pylorus is 5 cm and the bougie size is 38 Fr. We do not routinely dissect the entire hiatus; however, if a hiatal hernia is visible on preoperative studies or after dissection of the fundus and exposure of the left crus, we repair it. All the revisions for symptomatic GERD were performed by the same surgeon. Patients are discharged home on protein pump inhibitors for 15 days. Preoperative data recorded included standard demographics and comorbidities. Intraoperative data recorded included blood loss, operative time, and complications. Postoperative data recorded included length of stay (LOS), complications, weight and BMI from subsequent follow-up visits. The diagnosis of GERD was made based on a combination of subjective evidence (history and symptoms) and/or objective evidence (UGI contrast study, EGD, and pH studies). Patients with GERD as a comorbidity were extracted into their own database. Within the GERD database, symptoms and their onset, diagnostic imaging confirming GERD, specific surgical procedures performed, major complications, and medical management were recorded. The LSG GERD cohort was categorized into two groups. Group A was defined as having GERD de novo by the absence of any history or diagnosis of GERD prior to the LSG. Group B consisted of patients with documented diagnosis of GERD on treatment prior to LSG. We compared patients that had LSGs with de novo (Group A) and preexisting (Group B) GERD. The presence or absence of GERD, along with its severity, was recorded from the subsequent follow-up visits and compared with the preoperative GERD status. The change in GERD status among Group B patients was assessed and reported as unchanged, increased, or

decreased, as was need for medications. The time of onset of GERD in de novo cohort, Group A, was evaluated by the date the patient was assessed and primarily diagnosed with GERD. For the non-responders to medical treatment, the laparoscopic conversion to RYGB was performed by a single surgeon with our standard technique described in details in other publications. The pouch was created around a 32 Fr orogastric tube with an approximate volume of 15 cc or less. The gastric fundus, when left behind at the time of the original sleeve, was completely resected. The roux limb was measured at 100 cm and the biliopancreatic limb at 60 cm in every conversion. All data is expressed as mean with standard deviation. Data analysis was performed with the use of Minitab® Statistical Software. Results: A total of 919 patients underwent LSG during the study period. GERD was present in 38 patients (4%) of the total LSG cohort. In this cohort we identified two groups: Group A consisted of 25 patients (3%) with de novo GERD and Group B consisted of 13 patients (1%) who had preexisting GERD. In Group A, the diagnosis of GERD was based on the following criteria: symptoms/ history of PPI treatment = 11 patients (44%), UGI= 3 patients (12%), EGD= 11 patients (44%), and pH manometry= 0 patients (0%) (Figure 1). In Group B, the diagnosis was based on the following: symptoms/ history of PPI treatment= 10 patients (77%), UGI= 0 patients (0%), EGD= 3 patients (23%), and pH manometry= 3 patients (23%) (Figure 1). Group A developed symptoms between 1 month and 60 months (mean of 24 months) after surgery (Figure 2). Group B had 6 patients (46 %) with worsening reflux symptoms at 12 to 78 months (mean of 48 months)(Figure 3) and 7 patients (54%) reported no change of symptoms post-LSG.

In Group A, 1 patient (4%) underwent simultaneous hiatal hernia repair. In Group B, 3 patients (23%) underwent simultaneous hiatal hernia repair with no proof of improvement of GERD. The medical treatment was used in 36 patients (95%), of which 23 patients (92%) were in Group A and 13 (100%) were in Group B. The medical treatment for Group A was as follows: 1 patient (4%) was managed with over-the-counter drugs, 17 patients (68 %) were treated with low-dose PPI, 6 patients (24%) with high-dose PPI, and 2 patients (8%) not treated with PPI. The treatment for Group B consisted of 9 patients (69%) treated with lowdose PPI and 4 patients (31%) with high-dose PPI (Figure 4). A total of 4 patients (10.5%) failed medical treatment and required conversion to laparoscopic Roux-en-Y gastric bypass (LRYGB). In Group A, 1 patient (4%) required LRYGB, and in Group B, 3 patients (23%) required LRYGB. The outcome of surgical management for Group A was incomplete resolution of symptoms in the only patient, whereas in Group B, 3 patients (100%) had complete resolution of GERD symptoms after LRYGB. The average BMI loss after revision was 14 Kg/m2. There were no complications. Discussion: Laparoscopic sleeve gastrectomy has gained popularity as a definitive surgical approach to morbid obesity. Overall, the LSG results have been reported to be in between the LAGB and the LRYGB (11). Many of the studies have focused on the technical aspect of the procedure, regarding weight loss, complications such as staple line leak, and mortality. While many of the outcomes after LSG have been studied, there is little and contrasting data regarding the effects of LSG on GERD. Although LRYGB is considered an excellent option for obese patients with GERD, studies have shown no conclusive evidence that LSG improves GERD (9, 12)

. The Second International Consensus Summit for Sleeve Gastrectomy survey found that

6.5% of the patients who have had a LSG experienced postoperative GERD (13). This varying correlation of LSG with GERD can be plausibly explained by a number of anatomical and physiological factors, such as the alteration of the phrenoesophageal membrane, increased intraluminal pressure, variability of the gastric emptying, and enlargement or de novo formation of hiatal hernias. In the study presented here, the de novo incidence of GERD is 3%. Multiple studies have shown improvement in GERD complaints after LSG. These improvements have been routinely seen during follow-up at 2 to 3 years postoperatively and might be related to an improvement in overall gastric compliance (14, 15). However, a recent study by Himpens et al. (14)

revealed a biphasic pattern in the symptoms of GERD during longer term follow-up. In a

subgroup of 30 patients followed up for 6 years after LSG, GERD complaints were present in 23% of patients. Previously, this group of patients demonstrated a 22% GERD incidence at 1 year and then an incidence decrease to 3% at 3 years. The investigators commented that the development of a neofundus in long-term LSG patients, as well as a “relative midstomach stenosis,” contributed to increased acid production and might be the explanation for the increased incidence of GERD (16). We also observed that only a small amount of patients (3%) without GERD preoperatively had an increased risk of postoperative GERD symptoms that included heartburn, regurgitation, dysphagia, and hoarseness. This was a result similar to that seen by Fedenko et al. (17), who reported on anti-reflux sleeve gastroplasty. In their initial assessment of their postoperative LSG patients, they observed an increase in GERD symptoms, with all of their patients requiring PPIs to control their symptoms. In an attempt to prevent these symptoms, they combined multiple components of both the LSG and the Magenstrasse and Mill

procedure with techniques from a laparoscopic Nissen fundoplication. The postoperative GERD complaints were resolved after this procedure (16). LSG might anatomically compromise the antireflux mechanism (17). A prospective analysis was done of patients who had undergone laparoscopic adjustable gastric banding (LAGB) or LRYGB (18). These patients underwent both preoperative and postoperative endoscopy, 24hour pH probe, and manometry. The DeMeester scores in that study did not correlate with the clinical symptoms of GERD; multiple patients experienced GERD symptoms but had normal DeMeester scores (18). In their patient population, 61% of patients complained of heartburn and 41% of patients had regurgitation. Their study showed an improvement in GERD symptoms in postoperative LRYGB patients and an increase in reflux in patients after LAGB (18)

. This confirms what we know about the benefits of LRYGB for GERD. One study

reported that up to 22% of patients who undergo successful LRYGB continue to report symptoms of GERD postoperatively (19). Some have attempted laparoscopic hiatal hernia repairs with LSG to resolve GERD symptoms and promote weight loss (20). Himpens at al. (14) hypothesized the lack of gastric compliance due to gastric fundus removal, and elimination of angle of His was responsible for an increase of GERD symptoms at 1 year after LSG. In this present study, simultaneous hiatal hernia repair (HHR) done along with LSG showed no proof of improvement of GERD. This finding was similar to that by Santonicola et al., which showed that the procedure for HHR did not show any improvement in GERD symptoms (21). Interestingly, as mentioned, we found that 3% of patients who had no symptoms of GERD preoperatively actually developed significant GERD postoperatively that was present at follow-up at a mean of 2 years. Similarly, Carter et al (22) found that the risk of previously asymptomatic patients developing symptoms of GERD postoperatively ranged from 30% to

51%. During the past decade, an increasing number of reports described the development of GERD symptoms postoperatively. In a 2006 prospective randomized trial of LAGB versus LSG, there was a 22% incidence of de novo GERD at 1 year in the LSG cohort (23). A number of other single-center experiences reported cases of esophageal dysmotility, worsening of GERD, or de novo development of GERD after LSG (24-26). Overall, we found that 54% of patients who had preoperative GERD had no resolution of symptoms postoperatively. 46% actually had worsening of their symptoms postoperatively starting from 6 months to 6 years. Unless the patients have severe GERD not controlled on medications and/or evidence of Barrett’s esophagus, we do not exclude them from having LSG if they request it. However, we have a very detailed informed discussion with the patients outlining the possibility of worsening or new onset GERD after LSG. We also discuss the better option of having LRYGB, but in the majority of the cases, the patients remain firm in their decision of having a LSG. Since medical management was unsuccessful in a small portion of our patients, conversion to LRYGB was necessary in this series. Several series (27-29) have identified weight gain or severe GERD as the two most common indications for LSG revision. A study by Mohamed et al proposed LRYGB to patients with more severe obesity that had higher preoperative BMI. In this group of patients, symptoms of GERD and abnormal pH metric data were more frequent and severe, and the weight loss was higher after LRYGB. Similar improvement of reflux symptoms (30) and of pH metric data have been described after LRYGB (31). In addition, healing of esophagitis and improvement of Barrett’s esophagus have both recently been reported, (32, 33) and some authors have proposed LRYGB for severe reflux disease after vertical banded gastroplasty (VBG). In comparing our study, 100% of the patients who had

preoperative GERD showed resolution of reflux symptoms following LRYGB. Conversion to RYGB is reported to be an effective treatment for intractable reflux symptoms following LSG (34)

. However the de novo GERD group, in contrast, had one patient (4%) needing conversion

due to severe GERD, which did not have complete resolution of GERD symptoms after LRYGB. Limitations of our study include its retrospective nature, as well as the short follow-up. It is possible that the incidence of de novo GERD or the worsening symptoms could be greater with longer follow-ups. Also, the diagnosis of GERD or its resolution is not supported by objective pH studies. Finally, unfortunately we do not have anatomic details of the patients who required conversion to LRYGB. Hence it is not possible to know if specific technical anomalies of the original LSG (i.e. large fundus or sleeve volume, hourglass configuration of the sleeve, etc) played a role in the onset of GERD. Conclusion: In this retrospective study, the de novo incidence of GERD was superior (3%) to the worsening of the GERD symptoms in patients with pre-existing diagnosis (1%). However, the de novo group responded much better to medical treatment with PPI than did the pre-existing GERD group. For the small number of patients that did not respond to medical treatment, conversion to LRYGB was necessary and the pre-existing GERD group was found to have a better response , as compared to the de novo group. However, no definitive conclusions can be made due to the small sample size. Finally the concomitant repair of hiatal hernia did not prevent the development of GERD symptoms. Further studies are indicated to clarify the role of preoperative GERD in the selection of bariatric procedures, to evaluate the effect of LSG on reflux potential and GERD, to identify technical factors that may minimize the risks of persistent or de novo GERD after LSG.

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