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SAGES 13

Emerging bariatric technologies showcased at SAGES

Next-generation plication endoscopic stapler, OverStitch and TransPyloric Shuttle devices

Three next-generation devices showcased at this year’s meeting could offer gastrointestinal specialists options in the future for treating the obese patient. Promising clinical data revealed that a next-generation plication endoscopic stapler, as well as the Overstitch and TransPyloric Shuttle are safe and effective. Here, we take a closer look at the devices and the data…

Articulating circular endoscopic stapler

The BaroSense Articulating Circular Endoscopic (ACE) stapler for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract, incorporates a unique tissue capture mechanism to produce large, permanent serosa to serosa plications.

The device was recently assessed by researchers from Hospital Aleman de Buenos Aires, Argentina, who utilised the device to perform a totally endoscopic gastric plication (TEGP).

Between April and September 2012, 22 patients were recruited (one was excluded because of an oesophageal abnormality that prevented introduction of the overtube) with BMI 30-40 with comorbidities or BMI≥40, with no previous history of bariatric surgery. The procedure was performed under general anaesthesia, using the ACE stapler.

During the TEGP procedure, the volume and expansion of the fundus and greater curvature of the stomach are decreased to create an earlier sensation of fullness. The procedure is completed endoscopically, without laparoscopic assistance.

The procedure began with the introduction of an overtube to protect the oesophagus. The ACE stapler is then introduced under endoscopic view, and the instrument’s head positioned towards the gastricmucosa. A vacuum was used to create full thickness serosa to serosa tissue apposition and the stapler was then used to compress the tissue and deploy the staples, creating a TEGP.

Seventeen patients were available for ≥1 month follow. The mean age was 39, initial BMI 36.9, mean operative time 72 minutes and patients were discharged home on postoperative day 1-2.

The researchers reported that all adverse events have all been transient and mild-to-moderate in severity, and of the type commonly seen for an endoscopic procedure under general anaesthesia.

After seven days total mean weight loss was 4.9kg, 7.5kg at one month, 9.2kg at two months and 11.2kg (ten patients).

“This initial experience demonstrates that TEGP for the treatment of obesity is feasible and safe<” said the researchers. “Short term results are encouraging and long term follow up will prove its effectiveness.”

Overstitch

The Apollo OverStitch (Apollo Endosurgery) is an endoscopic suturing device which allows physicians to manipulate and suture tissue in the gastrointestinal tract without making incisions through the skin.

Endoscopic endoluminal greater curvature plication (EGCP) uses the Overstitch to reduce stomach size through approximation of tissues in a minimally invasive way. The procedure mimics a sleeve gastrectomy, achieving weight loss through gastric lumen reduction and increased early satiety.

Overstitch is a cap-based suturing system mounted on a double-channel endoscope, designed to perform full thickness plications, using 2-0 prolene thread with a curved needle arm mounted to the tip of the endoscope.

Four subjects underwent EGCP at Clínica Hospital San Fernando, Panamá, in June 2012. Patients had a BMI of 30-35 (mean 32.85), were 22-52 years old and had previously failed obesity clinical treatment. Main exclusion criteria were significant gastrointestinal diseases and previous digestive surgery.

Procedures were carried out in an inpatient basis, under general anaesthesia, after endoscopic evaluation of the upper digestive tract and insertion of the overtube. Interrupted sutures were placed in a way to “infold” the greater curvature creating a tube-like path, reducing gastric volume. Once completed, the Overstitch was removed and a gastroscope inserted to evaluate the result.

Mean operative time was 96 min (50-190), the longest procedure was in a J-shaped stomach, making plication more difficult. No intraoperative complications were recorded. By protocol, patients stayed in the hospital overnight for observation and diet followed the clinic’s bariatric diet.

All had pneumoperitoneum and light abdominal pain, treated with NSAIDs. Patient two presented nausea and vomiting, staying a full day in the hospital.

After six months of follow-up, mean weight loss was 15.35kg and mean %EWL 17.3.

Contrasted radiography revealed that the gastric lumen remained reduced, with an appearance similar to a sleeve gastrectomy. All patients reported early satiety, one mild nausea after ingestion of large amounts of food; no complications were reported.

Pneumoperitoneum occurred in all patients, showing that the stitches reach full thickness of gastric wall.

“EGCP is technically safe and feasible, with a low rate of mild adverse events,” said the researchers. “Longer follow-up and larger case series are needed to confirm our findings.”

TransPyloric Shuttle

The TransPyloric Shuttle (BAROnova) is a non-surgical device that is delivered endoscopically to the stomach and is intended to enable significant weight loss for obese patients.

The device has a functional shape consisting of a large spherical bulb connected to a smaller cylindrical bulb by a flexible tether and is composed primarily of medical grade silicone. In its functional, constructed state, the larger bulb assumes a shape of sufficient diameter to prevent migration from the stomach. The smaller bulb passes freely into the duodenum during normal peristalsis, allowing the device to self-orient and assume transpyloric positioning.

Once transpyloric, the compliant base of the larger bulb engages the pylorus directly to create an intermittent seal intended to reduce the rate of gastric outflow, enabling an overall reduction in caloric intake and weight loss.

The device is delivered and removed in outpatient endoscopic settings using a standard gastricover tube for access and oesophageal protection. The device is preloaded in a delivery catheter as a low-profile, single helical coil elongated to 65 cm for transoral delivery. During deployment, the delivery catheter is inserted through a pre-placed overtube, and the helical coil is dispensed into the stomach where the coil assumes its functional shape.

Delivery is complete when the delivery system locks and releases the formed TransPyloric Shuttle. The device then resides in the stomach for the desired treatment period. During removal, an endoscope is inserted into the stomach through an overtube and standard endoscopic instruments are used to unlock, capture and remove the deconstructed TransPyloric Shuttle through the overtube.

Researchers from the Prince of Wales Private Hospital, Sydney, Australia, designed a prospective, open-label, non-randomised, single-centre study to evaluate the safety and efficacy of the procedure and device.

Twenty subjects with a mean BMI 36.0±5.4 were enrolled and assigned to three month and six-month treatment cohorts. Throughout the study, surveillance endoscopies were performed to evaluate the device and gastric tissues.

Primary outcomes measures included %EWL, total weight loss and adverse events.

All devices were deployed and retrieved in 20 patients without complication. Mean procedure times for delivery and retrieval were 10.3± 3.9 minutes and 12.9 ± 6.4 minutes, respectively. Patients demonstrated minimal transient intolerance to the TransPyloric Shuttle and were able to quickly return to normal daily activity.

At three-months, a mean EWL 31.3%±15.7% and weight loss of 8.9kg ± 5.2 was recored. At six-months, patients achieved a mean EWL of 50.0± 26.4% and a weight loss of 14.6kg ± 5.7.

Observations of persistent gastric ulceration in two patients resulted in the decision to remove both devices approximately one to two weeks prior to their scheduled removal dates. Both patients recovered fully with no residual adverse effects.

“The TransPyloric Shuttle provides a safe and reliable nonsurgical method for weight loss with exceptional patient tolerance compared to surgical weight loss interventions,” said the researchers.

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