*2.1.2.2 Efficacy and safety profile*

*Recent Advances in Laparoscopic Surgery*

*2.1.2 ValenTx*

*2.1.2.1 Technique*

kick start further development to combat these issues.

other than the EndoBarrier, requires laparoscopic assistance.

esophagus together with the attached sleeve.

*The ValenTx gastro duodenal-jejunal bypass liner ([12], with permission).*

remain in situ for longer, thereby providing a more permanent solution. A recent study already demonstrated implantation of a new prototype for up to 3 years in two obese subjects with T2DM, but high frequency and severity of AE's still preclude the use of the device for a period longer than 1 year [11]. Efforts are made to

Another novel endoluminal gastro duodenal-jejunal bypass liner which has been introduced is the ValenTx (**Figure 2**) (ValenTx, Inc. Carpinteria, CA, USA) [12]. It is designed to reproduce the restrictive and malabsorptive features of the RYGB, by creating a gastric, duodenal, and biliopancreatic bypass. This gastro duodenaljejunal bypass liner is an implantation device which is delivered endoscopically, but

The procedure starts with an overtube placed through the pylorus at the level of the duodenal bulb. The liner, a 120-cm long fluoropolymer, is then delivered through this overtube via a delivery catheter up till the first portion of the duodenum. The liner, which has a polyester cuff attached to its proximal end, is deployed using computer-regulated pressure and flow monitoring under fluoroscopic guidance to ensure deployment of the liner into the proximal jejunum. Hereafter, the delivery catheter will be removed, and the overtube will be replaced for a shorter one leading up to the proximal cuff attachment. After this step, the laparoscopic part of the procedure will take place. After the placement of one 12-mm and three 5-mm trocars together with a Nathanson liver retractor, the gastroesophageal (GE) junction is dissected circumferentially at the level of the diaphragmatic hiatus. With an endoscope, the polyester cuff will then be positioned at the level of the Z-line of the GE junction and anchored with fullthickness sutures deployed in a circumferential manner. Full-thickness suture placement is secured under laparoscopic visualization. After cuff attachment, the final step in the procedure is approximation of the left and right diaphragmatic crura through laparoscopically placed sutures to prevent iatrogenic hiatal hernia. In order to remove the device, one has to circumferentially detach the cuff by endoscopic ligation of the eight anchoring sutures. The cuff can then be gently mobilized with an endoscopic grasper and subsequently be removed via the

**38**

**Figure 2.**

The first human experience with the ValenTx was gained during a single-center prospective trial among 24 morbidly obese individuals who met the National Institutes of Health (NIH) criteria for bariatric surgery [12]. In 22 patients, with a mean preoperative BMI of 42 kg/m2 , the liner was successfully implanted. One patient got excluded because of noncompliance with the preoperative liquid diet, and another patient suffered from significant inflammation at the GE junction to which the investigators decided to halt the procedure. A total of 5 out of the 22 implanted patients underwent the removal of the liner before the 12-week scheduled explantation, because of dysphagia presumably due to a too high placement of the cuff. This complaint completely resolved after explantation of the liner. After 12 weeks, the average % EWL in the successfully implanted patients was 39.7% (27–64%), which corresponded with an average total weight loss of 16.8 kg (8.6–30.8 kg). Moreover, the device demonstrated effective glycemic control during the trial. Except for the patients requiring premature explantation, no other adverse events took place. Therefore, the same research group designed a consecutive 1-year trial in which 13 patients with a mean BMI of 42 kg/m2 were enrolled [13]. In 10 patients, the device was successfully implanted and left in situ for 12 months. All 10 patients completed the 1-year follow-up without major complications resulting in a mean % EWL of 54% after 1-year and significant improvement of all comorbidities. Partial cuff detachment was observed in four patients during follow-up endoscopy, which indicates that the redesign of the anchoring mechanism is needed before further research can be done. While showing to be safe and able to achieve significant weight loss, further research is focused on a purely endoscopic deployment of this device. Unfortunately, further development and research on this device is currently hampered due to investment problems.
