Anterior Elevate Procedure for Cystocele
Over the past few decades there has been growing interest and investigation in graft use for surgical correction of prolapse and incontinence. The initial work stems from the general surgery literature, where they realized many years ago that abdominal hernia repairs had much higher cure rates when a graft was used to repair the hernia. This only makes common sense, and we have recently seen more and more data supporting graft use in pelvic floor prolapse surgery. With traditional repairs (i.e. not using grafts to augment our repairs) we are relying on repairs in which we are suturing weak tissue to weak tissue, under tension (which goes against all basic surgical principals!). It’s no wonder that we have poor cure rates! Today, very few abdominal wall hernias are repaired without a graft and we are now seeing similar trends in prolapse surgery. We have known for many years that abdominal sacralcolpopexy has the highest cure rate for vault prolapse, and that most likely is because a graft is used and we are not relying on the patients own tissue to hold up. We feel that grafts should be considered in patients that have had previous failure operations, older patients with poor tissue or patients with large defects or severe prolapse. Up until recently, these techniques were very invasive and fraught with high complication rates such as bleeding, bladder and/or nerve injury, graft rejection, and poor anatomic outcomes.
Perigee System – The First Transobturator Approach Released in the U.S.
The transobturator approach was the initial step to less invasive treatment for cystocele. In the early 2000’s, the transobturator space was initially described for the safe placement of slings to treat stress urinary incontinence. Dr. Moore and Miklos were two of the first surgeons in the United States to utilize this technique and bring this new technology to the United States. Despite the improved outcomes seen with the vaginal mesh procedures in certain patients, risks are known to still occur. Complications such as pain with intercourse, mesh complications (extrusions, infection, fistulas, vaginal pain, leg pain, pelvic pain, etc) have all been reported and have caused some concern regarding the procedures.
Dr. Moore and Miklos feel that many of these complications have occurred secondary to inexperienced surgeons completing the procedures and/or the procedures being completed in the wrong patients. Dr. Moore published a comprehensive review of vaginal mesh procedures in the Scientific World Journal (click here for download of the paper) in which he and Dr. Miklos reviewed all of the published data on mesh use in vaginal surgery and associated complications. In the paper (2009) results are summarized (including Perigee and Prolift studies) and also recommendations given to other surgeons on how to minimize the risks of complications.
The original Perigee procedure. Needles are passed through the groin to get the mesh into position.
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 (i.e. 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 (i.e. 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.
- 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