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Posterior Elevate Procedure – Modification of Apogee

Elevate – Posterior and Apical Support System For Rectocele, Enterocele and Vault Prolapse

• Treats rectocele, enterocele and vaginal vault
• ELIMINATES blind needle passes
• Improved Apical or Vault suspension
• Minimally invasive – only one small incision
• 20 - 30 minute vaginal outpatient procedure
• Completed under local/regional anesthesia
• One small vaginal incision
• Safe and effective

The Elevate system has been developed as a less invasive method to place a vaginal mesh graft in place, either in the anterior compartment (to support bladder) or posterior compartment (for rectocele/enterocele) and to achieve Vault support at the SAME time through only one small incision and no blind needle passes through the groins or buttock cheeks. The posterior system utilizes a central graft (made of a soft Type I macroporous polypropylene mesh….the type of mesh that has been shown to be best tolerated and have least complications in all studies to date in vaginal repairs) that is connected to two arms attached to the sacrospinous ligaments in the least invasive approach to date. The apical arms are placed into the ligaments with a very small self-fixating tip that is much less invasive than “hooking” around the entire ligament with a suture or passing a mesh arm through and through the ligament. It also has excellent and very strong fixation. In cadaver studies it took almost twice the amount of force to pull-out the self-fixating tip vs a mesh arm that was passed completely through the ligament (ie similar to Prolift or Pinnacle procedure). The mesh was actually modified approximately 2 years ago and made 50% lighter and less dense, without sacrificing the strength. With this change we have seen less complications with healing, less mesh extrusions, and most patients and their partners cannot even tell the mesh is in the vagina supporting the pelvic organs. In a recent study (2010 ICS/IUGA Study), 50% less extrusions were reported with this newer softer mesh compared to historical controls. Again, this was another modification made to reduce complications of mesh use. (2011 AAGL Study)

Fig 4 – The Posterior and Apical mesh graft. The body of the graft gives support over the rectocele and enterocele and top of the graft slides over the two arms attached up to the sacrospinous ligaments for apical vault support. The graft can be adjusted to the proper length prior to locking the graft into position on the arms.

Fig 5 – The yellow star shows the fixation of the Elevate system compared to the Apogee system (red star), ie it achieves a “higher” vault suspension up to the sacrospinous ligament without having to pass needles through the buttock cheeks.

Advantages of  Posterior Elevate Procedure

• Minimally Invasive! Eliminates blind needle passes
• No abdominal incisions (vs. Sacral Colpopexy)
• Decreased risk of bleeding (vs. traditional SSLF)
• Decreased risk of nerve injury (vs. Capio or traditional SSLF)
• No general anesthesia required (vs. Sacral Colpopexy)
• Decreased recovery period
• Treats rectocele, enterocele and vault in one procedure

Description of Posterior Elevate Procedure

The posterior/apical Elevate procedure (American Medical Systems, Minnetonka, MN) is a modification of the Apogee system that was used to treat rectocele, enterocele and vault prolapse with a posterior wall mesh and two arms that attached the mesh to the pelvic sidewalls up near the ischial spines. These arms were placed with blind needle passes through the buttock cheeks. The clinical results have been very good and complications minimal, however the Elevate system has made several improvements over the older system including: eliminating the blind needle passes through the buttock cheeks, eliminating the mesh arms penetrating the sidewall muscles (less risk of vaginal pain and/or pain with intercourse) and getting a “higher” or better apical support by using the sacropinous ligaments to attach the top of the graft. These ligaments have been long proven to give over a 90% cure rate for vault prolapse, however in the past we did not have as safe or as minimally invasive approach as the new Elevate system. The mesh used is exactly the same as the Apogee/Perigee systems which in many clinical studies has been show to be very well tolerated with minimal risk of infection or rejection.

The procedure can be completed under spinal/epidural or general anesthesia and typically takes about 30 minutes to complete. It is an outpatient, vaginal approach with only one small incision in the vagina. Typically patients just stay overnight just one night (23 hour outpatient type surgery) and return home the following day. Most patients return to their normal activities within a few days, however lifting restrictions are in place for approximately 6 weeks.

Fig 6 – The dissection is the same as for Apogee, ie a small incision is made vaginally and the dissection taken up to the ischial spines, however in the Elevate, the sacropsinous ligaments are isolated bilaterally. The apical arms are then placed, with minimal trauma to the ligament) approx 2cm medial to the ischial spine as above.

Once the apical arms are in place in the ligaments, the body of the graft is slid down over the arms and then adjusted into position with the adjusting tool. Prior to locking the graft in position, the tension is checked (typically via rectal exam) and if appropriate, the graft is locked in place with small little locking eyelets that are slid down the arms. The extra mesh of the arms are cut off, the lateral portion of the body of the graft sutured to the pelvic sidewall (the posterior arcus) on both sides and the distal portion attached to the perineal body.

The above picture shows a rectocele or defect in the rectovaginal septum causing a hernia of the rectum up into the vagina. In many cases, the vaginal vault or top of the vagina is prolapsing at the same time and should be suspended simultaneously with the repair.

This is achieved with the Posterior Elevate system. The graft covers the posterior compartment and treats the rectocele and enterocele and also gives apical support with two arms going up to the sacrospinous ligaments. The figure shows the final position of the graft.

Results and Complications

 Dr. Moore and Miklos have been experiencing excellent results using this new, minimally invasive technique for rectocele combined with vaginal vault suspension.  Success rates in the literature have been reported at approximately 90% (AUGS 2009 Abstract link) with MINIMAL complications. Dr Moore presented  the results of a worldwide multicenter trial at the International Urogyn Meeting in Toronto in 2010 which demonstrated cure rates at 90% and minimal complicatons and more data will be presented at the AAGL Meeting in Florida in the fall of 2011. They  have combined this procedure with their other innovative approaches to reconstructive surgery to continue to provide their patients with the best technology available to achieve higher cure rates, but not to jeopardize patient safety. Of course as with any vaginal surgery there are risks associated with the procedure, even though the risks are low with the Elevate procedure. These risks include: bleeding, infection, rejection or erosion of the mesh material, failure of the procedure, bowel or rectal injury, vaginal scar tissue formation and/or pain. Mesh is also permanent (which is one of the benefits, ie the support should stay there for the long term) however complications can occur with the mesh, that may require further surgery and there is no guarantee that further surgery will resolve these complications (as is true for any surgical complications or risks). 

In 2011, the FDA did issue a Communication concerning complications being reported from vaginal mesh placement (click here to view). Most of the complications reported have been concerning the “First Generation” mesh kits, that used a heavier mesh and blind needle passes and mesh arms placed through the groins and buttock cheeks. The Elevate procedure was designed to help minimize these risks and has done this, however still utilizes mesh placed vaginally for prolapse and all risks of surgery can never be totally eliminated. It is very important to note that the FDA did NOT recommend taking mesh off the market, nor did a recall of mesh, nor did they say it should not be used. They reported that mesh has been shown to have higher cure rates when used in prolapse surgery, however are concerned with some of the complications being reported recently with vaginal mesh placement and they want to ensure that patients are fully informed of the potential risks versus benefits and that all is being done to minimize complications.  Many of these complications seem to be directly related to surgeon experience and one of the principal findings was that surgeons need advanced training and experience in treating patients with these type of conditions. The American Urogynecologic Society (AUGS), as well as the American Assoc. of Gyn Laparoscopists and Minimally Invasive Surgeons (AAGL) have both supported this statement and made special note to state that mesh is indicated in certain patients, however surgeon experience is critical and vital in minimizing risks and maximizing the benefits. The AAGL even went as far as challenging some of the FDA findings based on the reporting system that is used to report these type of complications and the review of the literature in making some of their conclusions. (click here to view the AAGL Response to the FDA Notice). They note that many complications of non-mesh repairs are not reported to the FDA because they do not involve a “kit” or a “device” to place the mesh that is monitored by the FDA. They also note that “the current report by the FDA does not allow surgeon factors to be included in the analysis” and feel that this is the most critical factors in patient outcomes. It is well recognized by all that mesh is beneficial in many patients (NOT all patients) , however it is critical to patient safety to ensure the correct patients are receiving it by properly trained and experienced surgeons….. no-one will argue with this.

It should be noted that NO surgery is risk free and Prolapse and Incontinence surgery without mesh also carries many if not most of the same risks that mesh does and that in many cases it carries extra risk of failure. Dr. Moore and Miklos support mesh use, in prolapse and incontinence, in the right patient. They have used it for many years in their practice (over 10 yrs) with excellent outcomes and have reported many of their results at Scientific Meetings worldwide and in peer reviewed Medical Journals. They have helped develop many of the new technologies available and are considered world experts with mesh and non-mesh surgeries. They will continue to use mesh when indicated, with the appropriate informed consent of potential risks as well as alternatives. Without it, they could not get the cure rates they do and they have seen no increase in overall complications when compared to “traditional” surgery without mesh.  They support the FDA notification in regards to patients being adequately informed, given all risks/benefits and alternative choices and ensuring that surgeons have adequate training and experience that are performing these procedures. They also make themselves readily available to their colleagues and their patients to assist with any issues or concerns regarding mesh complications secondary to their extensive experience in the field. (Click here to view the doctors' letter to patients concerning above)

No single surgery is the answer for all patients, so Dr Miklos and Moore will evaluate your history and findings and discuss with you whether or not the Elevate procedure would be an appropriate procedure for your condition.  As with all procedures, they tailor the surgery to the patients age, medical history, and physical findings.

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Posterior Elevate