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Anterior Elevate Procedure – Modification of Perigee

Next step in minimally invasive treatment of Cystocele w/ Vault Prolapse in one Procedure

• Treats cystocele and vaginal vault w/one procedure
• 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 – same mesh

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 anterior 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 distal arms (also called the arms that support the bladder neck) are attached to the pelvic sidewall muscles with the same self-fixating tips, thus again eliminating the need to pass needles through the groins and pull mesh all the way out through the groin incisions. These self-fixating tips are the same tips that have been used with the Mini-arc sling for urinary leakage and have shown to be safe with excellent fixation and cure rates (for more details see our Minisling section)  The mesh used in the graft was actually modified approximately 2 years ago and made 50% lighter and less dense, without sacrificing the strength or the properties of the mesh (ie still Type I, macroporous, polypropylene). 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 (AAGL abstract for 2011, Comparison of Vaginal Mesh Extrusion), 50% less extrusions were reported with this newer softer mesh compared to the heavier mesh.  Again, this was another modification made to reduce complications of mesh use.  Eliminating external needle passes and using lighter softer mesh addresses directly the concerns of the FDA notification that was released in 2011, i.e. many of the complications were in regards to these things which elevate has eliminated, but still gives the advantages of higher cure rates.

Anterior Elevate Advantages over Perigee

• No needle passes through groins
• Single small vaginal incision
• Better vault support (Perigee did not have)
• Mesh arms not under tension through muscle
• Less risk of “banding” causing vaginal pain

Fig 1. The above diagram shows the higher vault support achieved with the Anterior Elevate procedure vs the Perigee procedure. The vaginal vault was not supported with the Perigee procedure and therefore a separate procedure needed done. The Elevate supports both the bladder and the apex (vault) of the vagina with one procedure and no needle passes through the groins.

Description of Procedure

The Anterior/apical Elevate procedure (American Medical Systems, Minnetonka, MN) is a modification of the Perigee system that was used to treat cystocele alone with an anterior wall mesh attached laterally at the bladder neck and with two upper arms that attached the mesh to the pelvic sidewalls up near the ischial spines. These arms were placed with blind needle passes through the groins. The clinical results have been very good and complications minimal (done by experienced surgeons in the right patients), however one disadvantage is that the Perigee system was not designed to support the apex of the vagina. The Elevate system has made several improvements over the older system including: eliminating the blind needle passes through the groins, 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.

A single small incision is made in the anterior vaginal wall under the bladder and a full-thickness dissection is completed separating the vaginal epithelium away from the bladder. The dissection is carried out to the sidewalls and an anterior approach is used to isolate the sacrospinous ligament on each side. The apical arms are then placed into the ligaments as above with the self-fixating tip holding the arm into the ligament. There is very little risk of nerve damage given the fact that the nerve runs behind the ligament and the tip is minimally traumatic, nor does it wrap around the back of the ligament (like other attachment devices).

The bladder neck arm with its self-fixating tip is then pushed into the sidewall on each side, giving distal support. The upper portion of the graft is then fed over the apical arms that have been placed in the sacrospinous ligaments (there are two eylets at the top of the graft that the arms slide through) and then using the adjusting tool as above, the graft is pushed up into position on the arms. The graft is checked for proper positioning and tension and then locked into place with locking eyelets that are slid down the arms. The extra mesh/arms are excised and the vaginal incision closed.

The excess mesh/arms are excised and the vaginal incision closed. Vaginal packing and a catheter are placed overnight and removed the next morning. If the patient has concomitant stress urinary incontinence, a sling such as the TOT or Mini-sling can easily be done at the same time.

Fig. 2 Anterior Elevate in position, supporting the Bladder and the Apex of the vagina.

Fig. 3 Elevate Graft in Position: Side-view of the pelvis showing the Elevate supporting the bladder and the top of the vagina (or uterus….which can be left in place and supported with the graft and hysterectomy avoided)

Risks and Complications

As with any surgical procedure, risks do exist. One must always weigh the benefits of graft use (increased cure rate) with the risks associated. For example if a patient has had 2 previous surgeries and they have failed, it is very doubtful that repeating the same procedure again will work, therefore it is very easy to state that this particular patient needs a graft for her repair and the benefits far outweigh the small risks associated. For the most part, risks associated with graft use in pelvic floor surgery are relatively small, however, again, as with any surgical procedure, risks do exist. A graft is a foreign body and therefore risks do include infection, rejection or erosion of the graft (into the bladder or urethra). These type of complications are very rare and the graft materials utilized today have been shown to be very well tolerated with minimal risk of this (all typically less than 1%) and of course experience of the surgeon also has an impact on these risks. Other risks include: bleeding, pain in the vagina or groins, vaginal scarring or pain with intercourse (risk of any pelvic floor surgery). One of the most common complications seen is extrusion of the graft through the vaginal skin. This can occur early with poor healing or later with poor tissue health and has been seen in 2% to 8% of patients. This is considered a minor complication and many times will heal on its own, however if it does not and the graft is exposed, this area will need excised and repaired. This sometimes can even be completed in the office.

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)

International Urogynecology Experience

Dr. Moore and Miklos have been performing anterior wall grafts for greater than 8 years and the newer modification of the Perigee procedure, i.e. the Elevate for more than a year. What should be remembered though, that this is a safer modification of a procedure they performed for more than 10 yrs. (i.e. the sacrospinous ligament suspension) therefore these techniques, the grafts, the procedures are NOT new procedures to them. They have once again been world leaders in this new minimally invasive technology to treat anterior wall prolapse (cystocele). They have been part of the United States multi-center trial evaluating and collecting research on the initial patients implanted with the Perigee procedure (Dr. Moore is principal investigator of this U.S. trial directing prominent sites from all over the US including the Cleveland Clinic and Harvard) and Dr. Moore was the first surgeon in the US to implant the Anterior Elevate and is also involved in multicenter trials evaluating outcomes. They have taught surgeons from all over the world and operated in Sweden, Finland, Spain, Italy, Greece, Turkey, Chile, Russia, Poland (and others) demonstrating these techniques. Dr. Moore has presented their research in the U.S. and has operated and taught surgeons internationally in Poland, Italy, and Australia, Colombia, Argentina, India, Dubai, Russia and New Zealand all in the past 2 years.

To date Dr. Moore and Miklos have seen excellent short to medium term clinical results in their patients. They have been performing vaginal mesh repairs for more than 10 years and the Elevate system for over 3 years. Results in the literature show that grafts have approximately 90% cure rate and the Elevate procedure has been shown to be consistent with this. Dr. Moore presented the first research data on the Anterior Elevate at the Annual AAGL Scientific Meeting in November 2010. This was the first paper in the world that presented one year follow-up on the procedure. (Click here to view Drs. Miklos and Moore's 1 year Data Paper). Dr. Moore is also involved with the largest multicenter trial in the world and presented these results at the International Urogyn Meeting in Toronto in 2010 and will present the longer term results at the AAGL meeting in November 2011 (click here to view abstract). Dr. Moore and Miklos have not had any patients complain of lagging post-operative pain (most patients state that the pain is very minimal and are up walking, moving with no problem day of surgery). No patients have had any nerve injury or major complications. The procedure takes less than 30 minutes to perform and can be completed under local or regional anesthesia. They have found this procedure to be very useful in patients with failed previous procedures, patients with previous retropubic surgery (such as Burch or Paravaginal repair), and in patients that are older or have large or severe prolapse. They also have found this approach useful in obese patients and women with retropubic scarring, in whom groin needle passage can be a challenge. This system will not treat urinary leakage, therefore if stress incontinence is an issue for a patient, this must be treated with concomitant sling (such as TOT/TVT or mini-sling), which can easily be completed at the same time. Of course, not all procedures are ideal for all patients. Dr. Moore and Miklos will discuss your individual case and determine what option for treatment is best for you.

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