Meet the REALIZE(TM) Adjustable Gastric Band

| November 10, 2008

by Thomas Sonnanstine, MD

Dr. Sonnanstine is Medical Director, Tristate Surgical Weight Loss Center, St. Luke West Hospital, Florence, Kentucky.

Introduction
Since the 1950s and the pioneering bariatric surgery work of Dr. Edward Mason and the development of intestinal bypass and gastroplasty, the surgical options available to those of us performing bariatric surgery have increased and evolved. The desire to both minimize the invasiveness of the operation and reduce detrimental side effects and failures led to the advent of gastric banding in the 1970s. Following the failure of these early “nonadjustable” gastric bands, Kuzmak et al developed an adjustable gastric band in 1986.1

Laparoscopic Adjustable Gastric Banding
In 1993, Belachew et al described a modified version of the gastric band that could be inserted laparoscopically.2 This quickly became known as the laparoscopic adjustable gastric band (LAGB) and quickly became popular in Europe, Australia, and Latin America. Two camps developed variations on the technique of the placement of this LAGB: Belachew et al utilized a perigastric technique for the placement of their device, which became known as the LAP-BAND®; Forsell et al developed the pars flaccida technique with their Swedish Band.3

Considerable progress and refinements of both the devices themselves as well as the techniques utilized to place the bands were made through the 1990s. By the time the LAP-BAND® gained FDA approval in June 2001, more than 120,000 LAGBs had been placed worldwide. The safety and weight loss efficacy of these LAGBs were demonstrated to be at least equal to that of vertical banded gastroplasty (VBG).4,5 Over time, it has become clear that LAGB is preferential to VBG both in terms of potential complications and failures as well as by the nature of its minimally invasive approach.

The Swedish Adjustable Gastric Band (SAGB)
From 1985 until 1995, the LAGB that was to become known as the Swedish Band was almost exclusively performed at Huddinge University Hospital by Forsell and his team.6 In 1996, Swiss company Obtech Medical began worldwide distribution of the Swedish Band. In 2002, Ethicon Endo-Surgery, Inc., acquired Obtech Medical AG and the international rights to the SAGB.

In 2003, a three-year, prospective, single-arm, controlled study at a combined 12 sites throughout the US commenced. The primary objectives of the study, in efforts to gain FDA approval of the SAGB, were to assess percentage of excess weight loss (%EWL) at three years postoperatively and to determine the rate of device-related adverse events (AEs). Inclusion criteria for the study were along the lines of the 1991 NIH Consensus Statement on Gastrointestinal Surgery for Severe Obesity:7 18 to 60 years of age, five-year history of obesity, BMI>40 and <55kg/m2 or >35 with comorbid condition(s), and documented failure of nonsurgical weight loss.

Three-year %EWL was 41 percent, while all reported AEs were in line with prior LAGB studies. Secondary endpoints identified in the study as being statistically significant were reductions from baseline in HbA1c, total cholesterol, LDL cholesterol, triglycerides, and HDL cholesterol levels.8 Based upon the success of this 12-center US trial, the FDA approved the SAGB, now known as the REALIZE(TM) adjustable gastric band, and injection port for use in the US.

The REALIZE(TM) Adjustable Gastric Band
The basic concepts of the original SAGB have been carried over to the REALIZE(TM) adjustable gastric band. These are the principles of a high volume/low pressure system, a wide and soft balloon, one universal size, 360° balloon coverage, and the pars flaccida technique of placement.

The velocity injection port and applier that were initially introduced in 2004 with the SAGB have been modified and are now known as the REALIZE(TM) Band Injection Port and Port Applier. This device enables the surgeon to apply the port to the abdominal wall fascia without the use of sutures and/or mesh. It allows for an expedient placement of the port with an anchoring system that has greater retention strength when compared with sutured ports.

Additionally, the target (septum) area of the port is up to 59-percent larger than that of the LAP-BAND® ports. As there is only one standard REALIZE(TM) adjustable gastric band port size, it is also the lowest profile injection port of any LAGB port on the market, minimizing patient discomfort and improving cosmetic appearance. Lastly, there is greater tubing protection at the connector site of the tubing with the port when compared with the LAP-BAND® System.

The appearance of the REALIZE(TM) band with radiographic imaging is also novel when compared with the LAP-BAND®. The orientation of the REALIZE(TM) Port may be discerned from an AP x-ray and/or fluoroscopy. This unique radiopacity of the port enables better ability to identify port flips and rotations that may require repositioning of the port with additional surgery.

The REALIZE(TM) adjustable gastric band is designed for and accompanied by the REALIZE(TM) Endoscopic Dissector. This disposable device allows for ease of passing the REALIZE(TM) band through the retrogastric space via the pars flaccida approach from the angle of His to the lesser curvature of the stomach.

Operative Technique
The basic technique of laparoscopic placement of the REALIZE(TM) band is very similar to the currently accepted techniques commonly used for all of the variations of the LAP-BAND®. The pars flaccida technique, as originally described by Forsell in 1996 with open gastric banding, is now well accepted as the standard for laparoscopic placement of adjustable gastric bands.9

Patient positioning and trocar placement should be identical to whatever technique with which the experienced LAGB surgeon is comfortable. There are multiple variations of trocar placement in both the supine and modified lithotomy positions. Utilization of both the EndopathR Xcel(TM) 15mm Bladeless Trocar (Ethicon Endo-Surgery, Inc.) and the REALIZE(TM) Endoscopic Dissector are recommended. The 15mm trocar, designed for placement of the REALIZE(TM) band, minimizes potential trauma to the balloon of the band and minimizes contact of the REALIZE(TM) band to the patient’s skin. Use of the REALIZE(TM) Endoscopic Dissector is optimal for creation of the retrogastric/retroesophageal space and passage of the REALIZE(TM) band from the angle of His through this space to the pars flaccida area.

My personal technique has changed a bit from the technique that I use with the LAP-BAND®. The patient is placed in the supine position in steep reverse-Trendelenburg position. Utilizing four 5mm EndoPathR Xcel(TM) Bladeless Trocars, a single 15mm EndopathR Xcel(TM) trocar, and the Omni-Nathanson Liver Retractor through the skin at the sub-xyphoid site, I stand on the patient’s right side. With aggressive retraction of the greater curvature of the stomach to reveal the angle of His combined with the usefulness of the endoscopic dissector, I have discovered that any dissection at the angle of His is largely unnecessary.

Opening of the pars flaccida is done bluntly and extended with the electrocautery bovie or Harmonic Scalpel, if necessary. At this point, I bluntly open a small, (less than 1cm) window anterior to the right crus of the diaphragm with a blunt grasping instrument. The REALIZE(TM) Endoscopic Dissector is then passed through this window and articulated through the thin connections at the area anterior to the angle of His. The smoothness and articulating ability of the dissector enables this maneuver to be done safely with little effort and little risk of injury to the posterior esophagus or stomach, all while keeping the retroesophagea/retrogastric tunnel narrow and relatively undisturbed.

It should be noted that the REALIZE(TM) band has enabled me to completely discontinue dissection not only at the angle of His, but also of the gastroesophageal fat pad. I feel that this is because of the ease at which the REALIZE(TM) band buckles in patients with a large range of BMIs, both male and female, as well as being due to its mobility on the stomach once buckled. Preparation of the REALIZE(TM) band at the back table has some minor differences when compared to the LAP-BAND®. Placing the band into the abdominal cavity is straightforward through the 15mm trocar. Passing the band through the posterior tunnel is done by hooking a pre-attached Ethibond suture onto the endoscopic dissector and passing the band instead of the tubing as is done with the LAP-BAND®. The band is to be oriented with the balloon facing the stomach wall.

I have found that use of the gastric calibration tube is entirely unnecessary given the fact that the REALIZE(TM) band sits so loosely on the stomach once buckled. Closing and locking the band may be achieved through a couple of different maneuvers, all of which are rather simple.

Placement of the gastrogastric plication sutures is done in a manner similar to that of other LAGBs. The following two things need to be considered: The balloon on the band is more exposed, so greater care is required when placing the sutures; also, wider (further on the fundus) suturing should be done to permit later expansion of the balloon in a “plication tunnel” once fills are initiated. I have found that, typically, two well-placed sutures are sufficient for good gastrogastric plication and overlapping of the body of the band. The use of laparoscopic suture-assisting devices is not recommended as it is important to have the assistance of a curved needle to enable thick bites of the needle and suture to the stomach.

Preparation of the fascia for placement of the REALIZE(TM) Band Injection Port requires an approximately 3cm by 3cm area of anterior rectus muscle fascia to be cleared off. The mechanism in which the tubing of the band connects with the injection port requires some attention to assure that the tubing connector locks into place. Care must be taken to assure that the balloon of the band is totally evacuated of all air once the system of the tubing and port are intact. At this time, the REALIZE(TM) Injection Port is connected to the port applier and the unit is placed through the incision and applied against the fascia. Using the trigger and firing lever on the port applier along with gentle downward pressure onto the fascia, the port is placed onto the abdominal wall. Checking the port manually, assuring that it is secured to the fascia, is recommended. The port may be repositioned with minimal difficulty if the surgeon is not satisfied with its initial placement.

Postoperative Care of the REALIZE(TM) Band Patient
The experienced LAGB surgeon should be comfortable in the management of the REALIZE(TM) band patient as it will be very similar to that of LAP-BAND® patient management. Personal preferences should be adhered to regarding the use of palpation or fluoroscopy for accessing the injection port. As always, a noncoring (Huber) needle should be the only type of needle that is utilized when accessing the REALIZE(TM) Band Port.

A couple of unique characteristics to be considered when performing band fills on the REALIZE(TM) band patient are the following: Due to the very low profile of the REALIZE(TM) Band Port, the tactile sensation when performing the fill will involve piercing the septum with the needle and then almost immediate contact with the back wall of the port; given the low-pressure system of the REALIZE(TM) band, there will be no back pressure of saline into the syringe upon accessing the port. Incomplete aspiration of the saline from the port/band will be the norm for such a low-pressure system. It is very unlikely that any patient will require a full 9mL of saline into his or her band in order to achieve maximal restriction on an appropriately placed REALIZE(TM) band.

My personal REALIZE(TM) band adjustment schedule consists of the first fill at four weeks postoperative and typically consists of 3mL in a male patient and 4mL in a female patient. Of course, this should be liberally adjusted depending upon any restriction that the patient is sensing and/or extremes of BMI. The second adjustment typically occurs at the eighth week postoperative, and I take the 3mL patients to 4mL and the 4mL patients to 4.5 or 4.6mL. Further fills occur at 1- to 2-month intervals and are typically in the 0.2 to 0.6mL range depending on the subjective degree of restriction that the patient feels.

REALIZE mySUCCESS(TM)
Via www.RealizeBand.com, REALIZE(TM) band patients can access pertinent information and create personalized fitness and eating plans. While not meant to be a replacement of the multidisciplinary surgical weight loss team and the one-on-one functions of the mental health provider and dietitian during the preoperative and postoperative phases of patient care, this website service can provide additional support to the REALIZE(TM) band patient. Each patient is given his or her surgeon’s practice identification number preoperatively and then a personalized Patient Card ID after surgery through which the patient may utilize the website to monitor and chart progress and even communicate with the surgeon’s team if that is desired by the practice.

Conclusion
Since the launch of the REALIZE(TM) band in late October 2007, over 1,000 bands have been placed with very positive feedback from surgeons and patients alike. Per FDA requirements, all bariatric surgeons with the intention of implementing the REALIZE(TM) band into their practice must attend an Ethicon Endo-Surgery REALIZE(TM) Band Training Course. After attending this course, the surgeon with sufficient experience may begin performing the

REALIZE(TM) Band operation and/or receive proctoring from a REALIZE(TM) band proctor. The universal size of the REALIZE(TM) band and port simplifies the necessary stock required for the operating room. The REALIZE(TM) Endoscopic Dissector is very cost-efficient when purchased along with the band and reduces the amount of dissection that must be performed at the angle of His. With use of the REALIZE(TM) Port Applier, suturing the port directly to the abdominal wall fascia or use of Marlex mesh and tacks can be eliminated with the confidence of secure placement of the port. Overall, in the nearly 200 REALIZE(TM) bands that I have placed, I have cut nearly 10 minutes, on average, off of my operative time. I have been very pleased with the results that my patients are achieving in terms of weight loss and the resolution of their comorbidities. Additionally, I think we have a good indication from the European, Australian, and now emerging US studies comparing the efficacy and complication rates of the laparoscopic adjustable gastric banding options that the REALIZE(TM) band is a valuable addition to the operative choices that we can offer our patients.

References
1.    Kuzmak L. Silicone gastric banding: a simple and effective operation for morbid obesity. Contemp Surg. 1986;28:13–18.
2.    Belachew M, Legran M, Defechereux T, et al.  Laparoscopic adjustable silicone gastric banding in the treatment of morbid obesity: a preliminary report. Surg Endosc. 1994;8:1354–1356.
3.    Forsell P, Hallber D, Heller G. Gastric banding for morbid obesity: Initial experience with a new adjustable band. Obes Surg. 1993;3:369–374.
4.    Cadiere GB, Himpens J, Vertruyen M, et al.  Laparoscopic gastroplasty (adjustable silicone gastric banding).  Semin Laparosc Surg. 2000;7:55–65.
5.    O’Brien PE, Brown WA, Smith A, et al. Prospective study of a laparoscopically placed, adjustable gastric band in the treatment of morbid obesity. Br J Surg. 1999;86:113–118.
6.    Forsell P, Hellers G. The Swedish Adjustable Gastric Banding (SAGB) for morbid obesity:  nine-year experience and a 4-year follow-up of patients operated with a new adjustable band. Obes Surg. 1997;7:345–351.
7.    National Institutes of Health Consensus Development Panel. Gastrointestinal surgery for severe obesity. Ann Intern Med. 1991;115:956–961.
8.    Realize Adjustable Gastric Band—Summary of Safety and Effectiveness (FDA Summary).  http://www.fda.gov/cdrh/pdf7/p070009b.pd
9.    Catona A, La Manna L, Forsell P. The Swedish Adjustable Gastric Band:  laparoscopic technique and preliminary results. Obes Surg. 2000;10:15–21.

Disclosure
Dr. Sonnanstine is a consultant to Ethicon Endo-Surgery, Inc.

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