12-Month Outcomes after Revision of Post Roux-en-Y Bypass Stomal and Pouch Dilation with an Endoscopic Tissue Anchoring System: A Prospective Case Series Report

| June 16, 2010 | 0 Comments

by Matthew L. Brengman, MD, FASMBS, and Gregory L. Schroder, MD, FACS, FASMBS

Dr. Brengman is from St. Mary’s Hospital, Richmond, Virginia. Dr. Schroder is from Dominion Surgical Associates, Bon Secours Health System Richmond, Virginia.

Bariatric Times. 2010;7(6):14–17

Objective: To evaluate safety and outcomes at 12 months, including anchor durability, with use of an endolumenal tissue approximation system for repair of dilated gastro-jejunal stoma and gastric pouch tissue after Roux-en-Y gastric bypass surgery. Design: Single-site, prospective case series. Study was part of a larger, multicenter registry of 116 patients. Patients who regained significant weight two or more years after Roux-en-Y gastric bypass surgery and lost 50 percent or more of excess body weight from the bypass were endoscopically screened for stomal and/or pouch dilatation. Qualified patients underwent endolumenal revision using this system to place tissue anchors to reduce stomal diameter and/or pouch size. Setting: Large, community-based hospital. Participants: Eight consecutive patients (mean age 47.8) were enrolled. Mean body mass index/weight prior to revision was 38.9kg/m2/105.8kg. Average weight regain was 32.1kg. Measurements: Data on safety, device intraoperative performance, amount of stoma and pouch reduction, postoperative weight loss, and any postoperative complications were recorded to date as part of follow up. Results: All eight patients were followed through 12 months. Average number of anchors placed intraoperatively was 4.8. Average stoma diameter and pouch length measurements were reduced by 50 and 42 percent, respectively, intraoperatively. Operating room time averaged 92 minutes. There were no significant intraoperative or postoperative complications at 12-month procedural follow up. At 12 months (N=8), mean weight loss was 12.1 kg, excess weight loss averaged 33 percent, and mean total body weight loss was 10.6 percent. Conclusion: Incisionless revision of stoma and pouch dilatation with this flexible, incisionless operating platform was performed safely and without complication at 12 months. Weight loss in this patient subset was demonstrated. This endolumenal approach has potential to effectively address weight regain post-Roux-en-Y bypass in a safe, less invasive, and durable manner. ClinicalTrials.gov Identifier: NCT01003743
URL: http://clinicaltrials.gov/ct2/show/NCT01003743?term=USGI+Medical&rank=2

Twenty to 30 percent of patients who undergo Roux-en-Y gastric bypass (RYGB) will experience significant weight regain.[1,2] The significantly increased morbidity and mortality with open or laparoscopic revision of the RYGB as compared to the primary procedure[3,4] often dissuades the clinician from performing, and the patient from seeking, surgical reintervention, despite of the documented benefits of this intervention on comorbidity and quality of life.[5,6] This is borne out by data that suggest that 3 to 10 percent of RYGB surgeries are revised yearly,[7] despite the higher rate of weight regain post-bypass. Considering there have been over 100,000 bariatric surgeries performed yearly in the United States alone over the last decade[8,9] (most of which were RYGB surgeries), the number of patients needing revision is likely to rise significantly in the coming years.

Mechanical restriction of the stomach by decreasing gastric size/volume is an important component of the RYGB. Although weight regain post RYGB is multifactorial, most patients with weight regain post-RYGB do have evidence of outlet and/or pouch dilation as compared to their immediate post-RYGB result.[10]

The ability to restore that restriction endoscopically through reducing the dilated pouch and gastric stoma is potentially a safer approach to addressing this common complication of RYGB surgery. A dilated pouch and/or stoma enlargement have been correlated with weight gain after primary RYGB surgery.[11,12]

We are participants in a multicenter, prospective registry utilizing an endoscopic tissue anchoring system (Incisionless Operating Platform™ [(IOP)], USGI Medical, San Clemente, California) for repair of a dilated pouch and/or stoma post RYGB. The IOP includes the TransPort™ multilumen platform, g-Prox® grasping/tissue approximation device, gCath™ tissue anchor delivery catheters, and a variety of endosurgical tissue graspers. Previous single-site and multicenter publications as part of this study reported a favorable safety profile and encouraged early weight loss associated with this technology and surgical approach at six months.[13,14] We now report on our site’s outcomes at 12 months.

Patient selection for this prospective, institutional review board (IRB)-approved registry was focused on evaluating the durability and outcomes of the tissue anchoring system for patients who regained significant weight following successful (i.e.,>50% excess weight loss) primary RYGB. The patients were required to be at least two years post RYGB and deemed able to make appropriate physician follow up with our bariatric practice. Preoperative nutritional assessment was performed. Patients meeting these clinical criteria were then screened with endoscopy to determine if they had a dilated gastric pouch and/or gastrojejunostomy and that their pouch lengths were greater than or equal to 4cm to allow adequate room for use of the IOP instrumentation. A hiatal hernia greater than 2cm on endoscopy was deemed to be an exclusion due to its potential impact on visualization and tool functionality. Informed consent from patients was obtained.

Clinical usage of this platform for gastric pouch and stoma reduction following RYGB has been previously described.[13–16] Patients underwent general anesthesia with endotracheal intubation in either the operating room or endoscopy suite. Our procedures were performed in the operating room setting. Initially, a gastroscope was inserted to inspect and plan the operative strategy with the system. The gastroscope was then removed and the TransPort™ (USGI Medical) access device (Figure 1) was inserted transorally and advanced into the pouch. Visualization with the IOP was achieved by insertion of a small diameter endoscope (Olympus GIF-N180 Endoscope, Olympus Endoscopy, Center Valley, Pennsylvania) through one of the four lumens of the platform.
Pressure-controlled carbon dioxide insufflation using a laparoscopic insufflator attached to the TransPort was delivered at pressures ranging from 10 to 25mmHg as necessary to keep the gastric pouch insufflated. Tissue graspers facilitated placement of the g-Cath™ expandable tissue anchors (Figure 2) on the gastric side of the gastrojejunal stoma to create tissue plications and thereby narrow the stomal outlet. Then, as necessary, tissue anchors were placed in the wall of the gastric pouch to decrease the volume of the pouch. Figure 3 demonstrates how the anchors hold the tissue fold together. Following gastric pouch and stoma reduction, the access device was removed, the patient was awakened from general anesthesia, and extubated. Our initial patients were observed overnight. We then transitioned to discharging patients in less than 23 hours.

Data on early and mid-term perioperative safety as well as any postoperative complications through 12 months were recorded. Intraoperative performance was tracked including pre- and postoperative pouch and stoma size, operative time, and the number of tissue anchors placed in the pouch and stomas. Stoma size was estimated using endoscopic biopsy forceps of known open jaw-span distance placed adjacent to the stoma before and after the procedure. Gastric pouch length was estimated using the endoscope markings at the incisors and placing the tip of the scope at the nearest lip of the stoma then retracting the scope to the top of the gastric pouch. Reported patient weight before their primary RYGB, reported patient nadir (i.e., lowest) weight following primary RYGB, current amount of regained weight, and actual preprocedural pouch and stoma size were among the metrics recorded. Calculation of excess body weight (EBW) was made based on body mass index (BMI) criteria from Dixon et al.[17]
Surgeon and nutritional follow up was performed at one, three, six, and 12 months. Patients were kept on a slowly advanced diet, starting with clear liquids and advancing to full solids by Weeks 4 to 5 postprocedure. Follow-up endoscopy was performed at three and 12 months.

Eight consecutive patients at our site who met inclusion criteria were enrolled. Table 1 shows our patient profile before endolumenal revision. All patients were women with a mean age of 48 years. Mean patient height was 165cm (range 155–180cm). Mean pre-RYGB weight/BMI was 134.5kg/48.9kg/m[2]. EBW pre-bypass was calculated at 66.8kg. Greatest mean weight loss post-bypass (bypass nadir weight) was 60.5kg. This translated to a mean EWL of 91 percent following RYGB. Pre-endolumenal revision mean weight/BMI was 106kg/38.9kg/m[2], respectively. EBW prerevision was 37.8kg. Patients had thus regained about 32kg or about 53 percent (32/60.5) of their original RYGB weight loss.

Intraoperative results are shown in Table 2. Mean initial gastric pouch length was 6.1cm (range 4–8cm) and mean initial gastrojejunal stoma diameter was 26.9mm (range 15–40mm). An average of 3.0 tissue anchors (range 1–5) were placed at the gastrojejunal stoma. A mean of 1.8 (range 0–6) anchors were placed in the gastric pouch, and a mean of 4.8 total anchors were placed in the procedures. Mean final gastric pouch length was 3.5cm (range 2–5cm) and mean final stoma size 13.2mm (range 6–20mm). The gastric pouches were reduced an average of 42 percent (range 28–57%) and the stomas reduced an average of 50 percent (range 20–68%). Mean operative time was 92 minutes. No serious intraoperative complications occurred. There was one device malfunction in one case in which the jaws of the g-Prox (USGI Medical) grasper required extra force to release the tissue from the jaws. Additionally suboptimal visualization and insufflation of the gastric pouch sometimes impaired case execution. We have found that it is imperative that the operator work quickly and efficiently, as tissue edema can significantly impair visualization via decreased ability to insufflate the pouch with prolonged cases, especially when the initial pouch size is less than or equal to 4cm.

Follow-up weight loss data were obtained at one, three, six, and 12 months. Three month follow up on all eight patients showed a mean weight loss of 8.7kg, with a mean EWL of 25 percent. Six-month follow up included only six of eight patients with mean weight loss of 12.1kg (range 5–30kg) and mean 29 percent EWL (range 10–45%). Twelve-month follow up of all eight patients (Table 3) showed a mean 12.1kg weight loss, 33 percent EWL, and mean total body weight loss of 10.6 percent.

Follow-up endoscopy was performed on five out of eight patients at 12 months. We saw no evidence of ulceration or gastric erosion at the site of anchors. We also had no incidence of outlet obstruction or stricture. Because the anchors sometimes become buried by surrounding mucosa, it can be difficult to visually confirm their presence at this time point. We visually confirmed the presence of anchors in 2 out of 5 patients. We were unable to visually confirm the anchors, but we did see evidence of durable folds in two other patients. Per personal correspondence with other registry participants and the study sponsor, the vast majority (92%) of endoscopies (N=65) performed at 12 months did confirm the continued presence of visible anchors.[18]

No significant late-term complications related to the procedure were noted in any patients (N=8) at 12 months.

Assessment of the clinical success of any bariatric procedure should be done in the context of both the safety and the weight loss outcomes, especially in the bariatric revision population. Technical capability and the drive for lower morbidity procedures has accelerated the development of laparoscopic bariatric surgery and continues to create the contemporary search for new less invasive, and safe procedures.

Sultan et al[19] documented that cardiovascular and other comorbid conditions could benefit with as little as 20 percent EWL from primary bariatric intervention.[19] Pryor et al,[20] in a survey of the American Society for Metabolic and Bariatric Surgery (ASMBS) members, showed that a vast majority of bariatric surgeons (73%) define success for an endolumenal revision procedure as weight loss of 10 to 20 percent EWL at one year with a risk profile equivalent to that of a therapeutic endoscopy.20 Our small case series at 12 months certainly raises the prospect that this approach and technology can meet or exceed those safety and efficacy benchmarks.

Other endolumenal approximation technologies have been unsuccessful or did not document durable tissue remodeling in the upper gastrointestinal (GI) tract at 12 months.[21,22] The g-Cath™ tissue anchors have shown evidence of 12- month durability in patients for a variety of gastric tissue approximation procedures, including gastric pouch and stoma repair and gastrotomy closure.[14,18,23] This may be due to the fact that the g-Cath anchors expand on placement to spread the holding force over a larger surface area and can “bend but not break” as the forces on the tissue fluctuate during the early phase of healing.

Excellent nutritional follow up is crucial to any successful outcome after a restrictive bariatric procedure. We have a dedicated team that works to ensure these patients stay on track, with appropriate counseling.

Previously, six-month, single- and multisite results from this registry have been published. Borao et al[13] reported a mean of 18 percent EWL in his single-site cohort of 18 patients at six months. Horgan et al,[14] reported the multisite results of a mean of 18 percent EWL at six months (N=96) with no serious adverse events or rehospitalizations for any patients. There was no reported post-procedure GI bleeding, stricture, ulcerations, or perforations.

All eight patients were initially considered successful with their primary RYGB, losing a mean of 60.6kgs, but were experiencing weight regain with a mean gain of 32.kg from their post-RYGB nadir weight at the time of their revision evaluation. Endoscopy demonstrated that they did, in fact, have enlarged gastric pouches and/or enlarged gastrojejunal stoma size. Interestingly, as noted in a paper by Horgan et al[14] the authors used statistical correlation to suggest that patients who had the most favorable outcomes were those that lost the most weight following their primary bypass procedure, as well as those who had adequate pouch size to execute the revision. Our results at 12 months confirm Horgan et al’s findings in the multicenter, six-month analysis. Our eight patient series achieved on average 91-percent EWL after their primary bypass, which was above the mean of 81 percent for the entire patient registry. This may have contributed to our outcomes, although no patient was excluded based on his or her initial results as long as he or she had lost at least 50 percent of their excess weight from his or her original bypass. Also, five of our eight patients had greater than or equal to 6cm of initial pouch working space, and these five patients did even better, averaging 38 percent EWL and more than 12-percent total body weight loss (TBWL) at 12 months.

Stoma size was measured using a premeasured biopsy forcep open jaw span placed adjacent to the stoma. Several limitations exist with this method of measurement. First the fisheye distortion of the flexible endoscopic lenses can make placement of the forceps variable and alter the perceived number of jaw spans necessary to cross the diameter of the gastrojejunal stoma.  Second, counting the number of jaw spans necessary to equal the diameter of the stoma is not precise. Third, the area of the stoma and not the diameter would provide a more accurate value to the restriction provided by the stoma to passage of food given the relation of stomal area to flow through the stoma. We personally feel that although it is helpful to screen patients with use of this method, its utility in documenting intraoperative results and long-term durability are limited at best.

Several patients in our series had comorbid conditions. Two out of three patients had improvement in arthritic symptoms at 12 months. One out of two patients had improvement in hypertension at 12 months. One patient reported improvement in gastric reflux and urinary stress incontinence at the 12-month mark. Satiety scores were not quantified well and were difficult to interpret. Although the procedure may have given them an earlier feeling of “fullness,” it was difficult to quantify what impact the procedure had on gastric emptying or any resolution of dumping syndrome symptoms, as these were not evaluated as part of the study. However, Borao et al[24] presented upper GI pre- and post-endoscopic revision data at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in Phoenix, Arizona, April 22–25, 2009, that suggested that the revision had indeed slowed gastric emptying. Other endolumenal suturing technologies have published evidence of the effect that revision has had on resolution of patient’s dumping syndrome symptoms.[22,25]

A technical challenge to successful endolumenal gastric bypass revision is that of adequate visualization and insufflation of the gastric pouch. We have found that it is imperative that the operator work quickly and efficiently, as tissue edema can significantly impair visualization via decreased ability to insufflate the pouch with prolonged cases, especially when the initial pouch length is less than or equal to 4cm.

We did have one case in which it was difficult to release the g-Prox grasper jaws from the tissue during anchor placement. This one instance required some extra force (and time) to release the tissue from the jaws of the grasper. There were no complications to the patient either short or long term.

We expect that next generation refinement of operative technique, improvements in device ergonomics, and better understanding of optimal patient selection for endolumenal revision will lead to favorable outcomes in the future.

Incisionless revision of stoma and pouch dilatation for weight regain following RYGB is achievable using IOP. We had good operative and postoperative safety. Mean weight loss at 12 months was significant with 100-percent adherence in this challenging patient subset. Anchor durability at 12 months was demonstrated. Based on our single site data, we feel this technological approach can offer patients another choice when considering their treatment options for weight regain post RYGB. We expect that with more experience with this platform, outcomes will improve. We hope larger studies will validate our one-year, single-site results.

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