Vaginal Vault Suspension

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					Vaginal Vault Suspension
Overview

Vaginal vault prolapse occurs when the apex of the vagina (upper 1/3 of the vagina) has
broken away from its original support structure known as the uterosacral ligaments. The
uterosacral ligaments hold up the apex and the uterus when the uterus is in place (Figure
1). When a patient has a hysterectomy, the uterosacral ligaments must be cut to remove
the uterus. In an attempt at preventing future vaginal apex or vault prolapse, the
uterosacral ligaments should be attached to the apex of the vagina after the uterus has
been removed.

If the patient did not have her uterosacral ligament attached to the vaginal apex or the
uterosacral ligaments did not remain attached after the surgery, the patient risks ending
up with vaginal vault prolapse after the hysterectomy (Figure 2). As the prolapse
continues to pull down, it will increase the risk of anterior and posterior paravaginal
defects.




                                                   Figure 2
Figure 1                                           Vault prolapse – if the uterus is removed
Uterine & vaginal vault prolapse - The uterus      (hysterectomy) and the surgeon does not
begins to prolapse because of the broken           reattache the uterosacral ligaments the patient
uterosacral ligaments                              is left with a vaginal vault prolapse.




Likewise, if the patient has uterovaginal prolapse and has a hysterectomy without regard
to precise closure of the vaginal cuff (ie the area where the uterus is detached from the
vagina), she may end up with an enterocele (ie a hernia) and a vaginal vault prolapse
(Figure 4). Once the uterus is removed the surgeon needs to meticulously repair the
edges of the support system of both the anterior (pubocervical fascia) and posterior
(rectovaginal fascia) vaginal walls. If the surgeon only closes the vaginal skin and does
not incorporate the supportive layers the patient will be left with an enterocele, which is a
true hernia at the top of the vagina.




                                                    Figure 4
                                                    Vault prolapse & Enterocele – if the uterus is
                                                    removed (hysterectomy) and the surgeon does
Figure 3                                            not reattach the apex of the pubocervical and
Uterine & vaginal vault prolapse - The uterus       rectovaginal fascia and only closes the vaginal
begins to prolapse because of the broken            epithelium (skin) the patient is left with an
uterosacral ligaments                               enterocele, also by not reattaching the
                                                    uterosacral ligaments like in figure 2 the patient
                                                    also is left with a vaginal vault prolapse.




IT IS VITAL THAT A VAGINAL VAULT SUSPENSION BE COMPLETED AT
THE TIME OF PROLAPSE SURGERY IF VAULT PROLAPSE IS EVIDENT,
WHICH IN MANY CASES IT IS.

Vaginal vault prolapse can also occur in many patients months or years after a
hysterectomy in conjunction with other pelvic floor defects such as cystocele, rectocele,
or enterocele. It is very important that the surgeon evaluates for vault prolapse in any
patient presenting with prolapse, because in many cases what appears to the
unexperienced examiner to be a cystocele or rectocele is actually vault prolapse. This
misdiagosis leads to improper or incomplete repair and usually causes shortening of the
vagina because the apex is not suspended up to its natural position. In many cases vault
suspensions are not completed by some surgeons secondary to being more advanced
difficult surgical procedures that require experience and training and therefore add
considerable time to the procedure in inexperienced hands.

Symptoms such as urinary frequency, urgency, nocturia, abnormal emptying of the
bladder and pelvic pain (described as the “posterior fornix syndrome”) that may occur
with vault prolapse or after prolapse surgery without vault suspension are relieved many
times following proper vault suspension as seen in the below sections.
Indications

Patients that experience vaginal vault prolapse often feel pressure, pain, protrusion and/or
dyspareunia (painful intercourse). There are different degrees of prolapse from mild to
severe. If the prolapse is mild, Dr. Miklos and Moore can offer a non-surgical approach
such as pelvic floor exercises (Kegal exercises) and/or pessaries. If the prolapse is
moderate or severe (extending outside the vagina), serious problems such as urinary
retention, dilated ureter or kidney and vaginal ulcers may occur and surgery is the next
step.




                                 Indications for Surgery

                       •   Moderate Prolapse
                       •   Severe Prolapse Causing Medical Problems
                       •   Failure of Pessary Management
                       •   Symptomatic Prolapse (pressure, pain)
                       •   Painful Intercourse




There are many ways to perform vaginal vault suspension. Drs. Miklos and Moore will
discuss the surgical options after a complete physical examination and a discussion with the
patient. Please click below for more detail:




                                Advanced Procedures for
                                 Vaginal Vault Prolapse

                •   Laparoscopic Uterosacral Ligament Suspension (link)
                •   Laparoscopic Sacral Colpopexy (link)
                •   Sacrospinous Ligament Suspension (link)
                •   Elevate Procedure (link)
Laparoscopic Uterosacral Ligament Suspension
The laparoscopic uterosacral ligament suspension involves suturing the uterosacral
ligament to the apex of the vagina. This procedure is normally performed by placing two
sutures through each uterosacral ligament and then through the cuff or apex of the vagina.
The suture is tied to support the cuff or apex to the uterosacral ligaments (Figure 3). Drs.
Miklos and Moore perform this surgery with no modifications to either the vaginal or
abdominal approach. Their only adjustment is utilizing the laparoscope, which provides
better visualization resulting in decreased incidence of bladder, ureter, and bowel injury
in their hands.




                          Vaginal vault support - the vaginal vault
                          prolapse is corrected by suturing the apex of
                          the vagina to its original supporting ligaments
                          known as the uterosacral ligaments




Advantages

Drs. Miklos and Moore have performed over 1000 laparoscopic uterosacral ligament
suspension procedures with an 85% success rate. They believe the laparoscopic
visualization of the uterosacral ligaments is superior to the vaginal visualization. One of
the major concerns is injuring the ureter during this procedure. Researchers at Duke
University Hospital confirmed that the uterosacral ligament suspension is one of the
procedures most likely to have a ureter injury.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=942373
7&dopt=Abstract
Techniques

By performing the uterosacral ligament suspension laparoscopically, our physicians are
able to reposition the vagina to its anatomic position in a minimally invasive manner.
Most surgeons perform this procedure through a large incision or through the vagina . A
large abdominal incision (laparotomy) will contribute to a longer recovery time. If
performed vaginally there is often difficult identifying the uterosacral ligaments
appropriately. The laparoscopic approach allows us to define the ligaments readily and
also identify the ureter making the laparoscopic approach safer in our hands.




Figure 1 – Open Laparotomy       Figure 2 – Laparoscopy             Figure 3 – Port Placement




Upon entry into the abdomen the bowel is mobilized or swept out of the cul de sac
allowing for a better view and easier access to the uterosacral ligaments (Figure 4)




Figure 4 – Laparoscopic View of Vaginal Apex (ie Vault)
This patient (figure 4a) had her uterus removed (therefore the top of the vagina is opened)
and a posterior repair with a graft placed (link to post. repair) and therefore one can see
the vaginal probe placed in the vagina to elevate it and the top or apex of the dermal graft
that has been used to augment the posterior repair. This portion of the dermal graft will
be sutured to the top of the vagina (apex) which will then be attached to the uterosacral
ligaments.




               Figure 4a: Top of vagina open after removal of uterus



By suturing the uterosacral ligaments to the apex of the vagina, this restores the vaginal
apex back to its normal anatomic position. (Figure 5)




                                              Figure 5 Uterosacral ligaments are sutured
                                              to the apex of the vagina (ie vault) Note: the
                                              surgical instrument is on the vaginal apex.
In this patient, the vaginal vault is closed (after hysterectomy) and the apex of the vagina
is elevated and a suture is placed through the base of the uterosacral ligament as seen
below.The suture is then placed through the apex of the vagina (top of rectovaginal
fascia, dermal graft(if placed) and pubocervical fascia) and tied down. Two sutures are
placed through the ligament and then through apex on each side for a total of 4 sutures to
elevate the vagina.




       Figure 6: The first suture for the suspension is taken through the right uterosacral
       ligament then up through the apex of the vagina.




The final view shows the patient with two sutures through each uterosacral ligament, a
total of 4 sutures, then through the apex of the vagina. ( Figure 6a) This surgical
procedure is the most anatomic surgical procedures for restoring the vaginal apex back to
its original position. At one time the uterosacral ligaments held the uterus in place but
once the uterus is removed the surgeon should then attach the ligaments to the apex of the
vagina.




Figure 6a – Completed Laparoscopic uterosacral ligament suspension




Results/Complications

Drs. Miklos and Moore have approximately a 2% complication rate in comparison to
9.5% during the same procedure at Duke University. The only difference being that
Atlanta Urogynecology utilizes a laparoscopic technique vs. Duke’s vaginal technique.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=942373
7&dopt=Abstract



                        Uterosacral Ligament Complication
                                       Rate

                 15
                 10                            9.5
                              2                              Ureter Injury
                  5
                  0
                          Atlanta        Duke University
                       Urogynecology
By performing the uterosacral ligament vault suspension laparoscopically, Drs. Miklos
and Moore can also offer other reconstructive supportive procedures simultaneously such
as:

   •   Paravaginal Repair
   •   Enterocele Repair
   •   Posterior Repair
   •   Fistula Repair
   •   Sling Procedure (TVT/TOT/Mini)



Other risks of the procedure include: failure of the procedure secondary to the ligaments
being weak , nerve injury or pain (<1%) secondary to tension or injury to the lower sacral
nerve roots, pelvic floor muscle spasms (typically short-lived and treated with muscle
relaxants), pain with intercourse at apex of vagina (1%) from scar tissue, shortening of
the vagina (<2%). Dr Moore and Miklos again feel the laparoscopic approach helps
minimize these risks secondary to having better visualization of the ligaments and the
anatomy surrounding the ligaments.


Atlanta Urogynecology Associates Experience
Drs. Miklos and Moore have performed the laparoscopic uterosacral ligament procedure
over the past 10 years with approximately 80-85% success rate in selected patients. We
believe that this minimally invasive approach is a safe and effective way to suspend the
vagina. Patients usually go home the next day and experience minimal pain and
discomfort. It is their experience that most patients are pain free within 2 weeks. Some
patients do suffer from some pelvic muscle spasms and discomfort from this called
levator myalgia, secondary to muscles reacting to the procedure. Patients are treated with
muscle relaxants and this discomfort typically resolves in a week or two. Dr Moore and
Miklos believe that with patients that have moderate vault prolapse, that this is a very
good approach to utilize. Although the laparoscopic sacralcolpopexy with mesh (link) has
a higher cure rate, the uterosacral vault suspension utilizes the patients own tissues
therefore decreases the risk of adding mesh to the procedure. It is a very anatomic repair
that offers excellent cure rates in this group of patients. However, in patients that have
more severe vault prolapse it has been shown that the sacralcolpopexy with mesh has a
much higher long term cure rate and therefore in those patients they will recommend
adding mesh to the repair with this procedure. It only makes sense that in more severe
prolapse, the ligaments are stretched out and not very strong, therefore the addition of
mesh is necessary. In these patients, Dr Miklos and Moore feel the benefits of the mesh
outweigh the risks. Each individual patient is counseled however in the risks/benefits of
both approaches and ultimately it is the patient’s decision on which procedure they feel
comfortable with.
Laparoscopic Sacral Colpopexy

The abdominal sacral colpopexy is one of the most successful operations for vaginal
vault prolapse with excellent results. It involves suturing a synthetic mesh that connects
and supports the vagina to the sacrum (tailbone). This procedure is complex in its nature
and requires great expertise for a favorable outcome. Drs. Miklos and Moore have been
performing the laparoscopic sacral colpopexy in the same manner as an open procedure
with the exception of using a laparoscope over the past 5 years. They have the largest
series of laparoscopic sacralcolpopexies ever published in the world. They recently
reported the results of almost 500 cases, completed over the past 3 years at international
meetings in Russia, Mexico and the United States. This was one of the featured research
papers presented also at the 2007 American Urogynecologic Society Meeting in Miami,
Fl.(link to abstract here, or power pt presentation). Many physicians and academicians
do not believe the laparoscopic sacral colpopexy can be performed in a safe and efficient
manner. Their paper has recently been published in the Journal Of Minimally Invasive
Gynecology and it is the largest series in the world on Laparoscopic Sacralcolpopexy (put
pubmed index link here or link to pdf copy of paper.) Drs Miklos and Moore can perform
this procedure in less time with more sutures than the open sacral colpopexy. Drs Miklos
and Moore do not believe in changing the technique of the operation but only the mode of
surgical access into the abdomen.
Advantages
By performing the sacral colpopexy laparoscopically, our physicians are able to
reposition the vagina to its anatomic position in a minimally invasive manner. Most
surgeons perform this procedure through a large incision thus contributing to a longer
recovery time. Our laparoscopic approach also allows us to incorporate additional
laparoscopic procedures if needed.




Figure 1 – Open Laparotomy       Figure 2 – Laparoscopy             Figure 3 – Port Placement




Drs Miklos & Moore can perform the laparoscopic sacral colpopexy ( Figure 2 & 3) in
less time, less blood loss, smaller incisions and perform the surgery more precisely than
by doing it through an open laparotomy (Figure 1). They are one of only a few centers in
the country offering this procedure through the laparoscopic approach and are by far the
most experienced in the country with the technique. Surgeons from all over the US and
internationally have come to their center to learn their techniques.




Surgical Technique


After placing the four small incision sites noted above (Figure 2) and then placing the
access ports (Figure 3), the bowel is mobilized out of the deep pelvis and the sacrum
(tailbone) is identified (Figure 4). The peritoneum over the sacrum (tailbone) is elevated
(Figure 5) and then incised (Figure 6).
Figure 4 – Sacrum             Figure5—Peritoneum elevation           Figure 6-Incision


A sponge stick is placed into the vagina to elevate the apex or vaginal vault into the
surgical field (Figure 7).
Fig 7a. Laparoscopic view of vaginal vault with probe in vagina elevating the apex up into the pelvis




Figure 7b-- Vaginal vault (apex) : Probe holds vagina up from below




The peritoneum covering the apex of the vagina is incised and the bladder is dissected
away from the top of the vagina anteriorly and the rectum dissected away posteriorly.
A piece of mesh which is shaped like a Y (Figure 8) is then attached both to the posterior
aspect of the vagina apex (Figure 9) and to the anterior vaginal apex (Figure 10).




                                    Figure 8 - Y-shaped mesh
Figure 9 - Anterior mesh attachment
Fig 10- Posterior mesh attachment




The long arm of the Y-mesh is then pulled up to the sacrum and subsequently attached.
Figure 11 shows the placement of sutures into the sacrum, which will then be attached to
the mesh. By attaching this suture to the mesh, the vagina is supported to the sacrum via a
bridge of mesh between the vagina and sacrum. (Figure 12) The mesh is attached
distally to the vagina (anterior & posterior) and proximally to the sacrum (Figure 14).
Firgure 11- Placing suture in sacrum
Figure 12 - Mesh from vagina to sacrum




The peritoneum, which was originally incised and opened at the beginning of the
operation, is now closed over the mesh ( Figure 14). This part of the surgery does not add
support to the surgery but is thought to decrease potential complications, like bowel
obstruction and adhesions.
Fig 13 – Covering over the mesh with peritoneum
Figure 14- lateral view of mesh attached to the both anterior wall and posterior wall of
vagina and then to the sacrum (tailbone)




Results/Complications
Drs. Miklos and Moore have an excellent success rate with the laparoscopic sacral
colpopexy. Their rates, recently reported at the American Urogynecology Society
Annual Mtg and now published in the JMIG peer reviewed journal (link again here to
article) are equivalent to an extensive review of the open abdominal sacral colpopexy
procedures at most major universities. The cure rate of the laparoscopic sacral colpopexy
is approximately 90-96%.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9
052607&dopt=Abstract

In Dr Miklos and Moore’s recent study of 463 patients undergoing Laparoscopic
Sacralcolpopexy, their cure rate at one year is 98%, with minimal complications noted.

Some of the complications that can occur during sacral colpopexy include:



                             Sacral Colpopexy Complications

                         •   Mesh Infection
                         •   Mesh Erosion
                         •   Bleeding
                         •   Pain with intercourse                                            Formatted: Bullets and Numbering


Dr. Miklos and Moore have a <1% intra-operative complication rate during this
procedure due to their vast experience in advanced pelvic reconstructive surgery. They
view the laparoscopic approach only as a mode of surgical access. The laparoscope does
not modify their technique in performing the procedure. Risks such as mesh infection or
rejection are very rare with the newer mesh used, which is a macroporous soft
polypropylene mesh (Type I mesh). In their recent series of almost 500 cases, only one
mesh had to be removed secondary to infection (cuff infection at time of hysterectomy)
and one was removed secondary to a question of an inflammatory reaction. No other
infections attributed to the mesh was seen.

The most common risk of the use of mesh at the top of the vagina, is mesh extrusion
through the vaginal skin, which is typically a minor complication, but one that does need
a procedure to excise the exposed mesh and repair the skin where it came through. This
risk exists whether the procedure is completed through an open incision or the
laparoscope, however in their recent study, Dr Miklos and Moore reported an overall
extrusion rate of only 1.2%, which is lower than most other reports in the literature. They
also showed that women with hysterectomy were no more likely to suffer a mesh
complication (such as extrusion, infection, pain, bowel symptoms) than patients that
already previously had a hysterectomy. Please click here to view the ABSTRACT from
the AUGS 2007 meeting, or the PAPER submitted for publication reporting on their
results.

Atlanta Urogynecology Associates Experience
Drs. Miklos and Moore have performed the laparoscopic sacral colpopexy procedure over
the past 52 years with a success rate comparable to the abdominal sacral colpopexy (large
incision). They have also seen a much lower complication rate by performing it
laparoscopically instead of through a large incision. By maintaining the same principles
of this original proven surgery, Drs. Miklos and Moore can offer their patients the most
advanced mode of entry to a highly successful surgery that corrects vaginal vault
prolapse. They have the largest series of laparoscopic sacralcolpopexies ever reported in
the world to date and have reported on their results and have taught the procedure all over
the world. Physicians and surgeons from institutions such as Dartmouth, Univ. of
Louisville, George Washington Univ, Cleveland Clinic, Harvard, Johns Hopkins, Brown
Univ, Univ Cincinatti in the US as well as surgeons from all over the world including
Australia, Chile, France, Korea, Japan, Sweden, S. Africa, Greece, and others have come
to their center in the US to learn their techniques (link to physician testimonials here).
They also get invited on to typically 3 to 5 centers throughout the world to travel to the
center to do live surgery to demonstrate their technique to teach other surgeons. Last year
alone they operated in Portugal, Russia, Chile, Greece, Turkey, S.Africa and Dubai.

Some centers now are offering Robotic Assisted Laparoscopic Sacralcolpopexies. The
robot is used to perform the same procedure Dr Miklos and Moore are performing and is
used by surgeons that otherwise are not able to do the surgery laparoscopically. It allows
some surgeons the ability to do a surgery laparoscopically, when otherwise they could not
it this way because of the technical difficulty of the procedure and the advanced skills
necessary. Dr Miklos and Moore do not use the robot, because it offers them no
advantage and actually is a disadvantage because of the time and cost involved it takes to
do the procedures robotically. Dr Miklos and Moore typically complete the procedure in
less than 45 minutes and in most series using the robot, it takes 4-6 hours, therefore
adding risk of increased operating time to the procedure (ie longer anesthesia, longer time
of the patient being in the operating room). It does however offer some surgeons the
advantage of doing the procedure laparoscopically instead of through a large incision and
if it can be done in a reasonable time frame, this is an advantage to the patient (ie instead
of having a large incision in the abdomen).




(new-replace whole section)
Sacrospinous Ligament Suspension

The sacrospinous ligament suspension fixation (SSLF) procedure is a less invasive and
moderately successful operation for vaginal vault prolapse. Drs Moore and Miklos have
performed this procedure in the past, however they think that in its traditional form (see
below for description of this) has a very limited role in vault suspension surgery with the
newer less invasive vaginal approaches available today, such as the Elevate procedure
(link).. It is a procedure that is completed vaginally at the same time of other vaginal
repairs in certain patients. Traditionally the vaginal vault is attached to the ligament by
one or two sutures on one side. The literature has shown that this is not a very anatomic
repair (pulling the top of the vagina off to one side, see Fig. 8 below). Dr. Moore and
Miklos also feel that it is not a very secure repair because the only thing that is sutured to
the ligament is vaginal skin and they feel failures occur because the suspension sutures
pull out of the vaginal skin. Additionally, traditional use of a suture carrier, such as the
Maya hook or the newer Capio suture hook, risks damage to the pudendal nerve/vessel
complex that can result in nerve injury, pain or severe bleeding.

Drs Moore and Miklos Early Modification of the SSLF
In the late 1990’s early 2000’s in some patients that were not be candidates for abdominal
surgery or were felt to be better candidates for a vaginal approach under epidural
anesthesia, Dr. Moore and Miklos did utilize the patients sacrospinous ligaments to
complete a vaginal vault suspension. However, they modified the procedure by utilizing
both ligaments in the suspension (bilateral SSLF) and incorporated a graft into the
suspension which they felt strengthened the suspension significantly. The apex of the
dermal graft that they placed during their posterior repair or during an anterior repair was
attached to the top of the vagina (all the way across the entire width of the vagina).
Sutures were then placed through the sacropinous ligaments (see below) and then through
the top of the graft at each corner. The sutures were then tied down which elevates the
vagina up very nicely without deviating it to either side. This modification that Dr Miklos
and Moore were doing actually set the groundwork for some of the recent less invasive
procedures such as the newer Elevate procedure below.



“Old” Technique
The sacrospinous ligament technique is described below. Images are from Technique
Spotlight Suture Placement, Vol 3 by Boston Scientific featuring the use of the CapioTM
Suture Capturing Device. The procedure is completed vaginally.
Results/Complications
Drs. Miklos and Moore did see good results with this procedure in the past with the
bilateral sacrospinous ligament suspension incorporating a graft placed either along the
posterior or anterior wall, however did not utilize it on a regular basis secondary to the
risk of nerve or vessel damage with the older techniques (such as the Capio device) that
placed a suture around the ligament or “hooked” the ligament which can cause nerve
impingment or compression. They felt it was a procedure that should only be completed
by experienced advanced pelvic surgeons. Risks include bleeding or hematoma in the
pararectal or retropubic space (depending on posterior or anterior approach), injury or
irritation to the pudendal nerve (buttock or leg pain), rejection or infection of graft
material used. With the newer less invasive methods now available such as the Elevate
procedure, Dr Miklos and Moore do not complete this older more invasive repair.




(new replace Apogee section-remove apogee fm all areas in website)
Elevate Procedure: New minimally invasive
vaginal approach to treat vault prolapse at
same time as Rectocele and/or Cystocele

As stated previously, many surgeons may not complete a vaginal vault suspension at the
time of prolapse surgery, even if the patient has vault prolapse, because of the difficult
and complex nature of the procedures reviewed above. This can lead to problems such as
a shortened vagina, pelvic pain, painful intercourse, urinary symptoms (urgency,
frequency, nocturia, difficulty emptying) that can occur post-operatively if the vaginal
vault wasn’t properly suspended (Posterior Fornix Syndrome)


                              Symptoms of vaginal vault
                             NOT being suspended properly

                              -Urinary frequency, urgency
                              -Difficulty emptying bladder
                              -Constipation (straining to evacuate)
                              -Vaginal pressure, pain
                              -Painful intercourse

Recent interest has focused on less invasive operations for vault suspensions such as
laparoscopic procedures, however as Dr Bruce Farnsworth, a well known
Urogynecologist from Australia, recently quoted, “Laparoscopic procedures require a
high degree of skill and extensive specialized training. As a result, only a minority of
surgeons achieve competence in these methods”. Additionally, as reviewed above,
bleeding or nerve damage are potential risks of the traditional sacrospinous ligament
suspension.

Because of this, a less invasive approach for vault prolapse was developed and studied in
Australia and Europe that was an outpatient procedure that applied the tension-free
vaginal tape principle to the posterior part of the vagina called the Posterior IVS
procedure. Dr Moore and Miklos were some of the first surgeons in the United States to
evaluate this system and did some of the first research in the modifications of the system.
This ultimately led to the vaginal mesh procedure kits that have become more popular
over the past several years such as the Apogee/Perigee system, Prolift, Avaulta, etc.
These kits utilized mesh placed in the anterior (bladder) or posterior (rectocele) vaginal
compartments with needled passed through the groins or buttock cheeks to get them in
place. The posterior graft kits had arms coming off the top of them that would be attached
to the pelvic sidewalls in an attempt to support the top or vault of the vagina.
Figure1: The above figure depicts the original Posterior IVS tape procedure for vaginal
vault suspension. The Apogee procedure was a modification of this procedure that adds a
posterior wall graft in addition to the tape at the vault so that the entire posterior
compartment can be treated, in addition to the vault.




Fig 2. The original Apogee System with posterior wall mesh that treats rectocele and
enterocele, and apical arms designed to suspend the vault of the vagina
The traditional approach with the vaginal mesh kits was to utilize the posterior approach
to place a graft to treat the rectocele and enterocele and then utilize arms at the top
portion of the mesh to support the vault or the apex of the vagina. The mesh arms at the
top of the graft were designed to be attached to the pelvic sidewall muscles by passing
needles blindly through two incisions in the buttock cheeks and ischiorectal fossa and
penetrating the pelvic sidewall muscles up near the ischial spines. The arms at the top of
the graft were attached to the needles and pulled back through the incisions in the buttock
cheeks. (see Apogee procedure below). This supported the top of the vagina at the level
of the ischial spines and the body of the graft repaired the rectocele and enterocele. The
Prolift procedure arms could also be placed like this or were sometimes taken up through
the sacropinous ligaments from below, which Dr Moore and Miklos did not believe in as
they felt it was a very dangerous blind pass. There has been some controversy over these
type of procedures because of complications that have been reported. (put link here for
Vaginal Mesh Kits: Friends or Foe paper) Many studies have been completed that have
shown increased cure rates compared to traditional repairs without mesh with low rate of
complications, but risks such as vaginal or pelvic floor pain, pain with intercourse, mesh
extrusions into the vagina or erosion into the rectum have been reported. Dr Miklos and
Moore do feel that many of these complications may be secondary to inadequate
experience by the implanting surgeons and/or the wrong patient selection. They have
used these techniques in select patients and had very good results and were involved in
several studies involving the Apogee (Rectocele and Vault) and Perigee (Cystocele)
systems. Dr Moore is actually one of the leading investigators in the US in the Perigee
system and is Principal Investigator in an ongoing multicenter US trial on the system that
will continue to follow patient for 5 yrs. He recently reported on the results of the trial at
the 2009 International Urogyn Meeting in Italy (link to abstract). Cure rates in the range
of 90% have been seen with minimal complications in this predominantly (over 85%)
postmenopausal age group.




Fig 3a,b. The Apogee procedure involves the blind passage of a needle through the
buttock cheek and then it penetrates the pelvic sidewall muscle near the ischial spine. The
lateral mesh arm at the top of the mesh is then attached to the needle and pulled back
through the muscle and the incision. The arms support the top of the vagina and the body
of the graft treats the rectocele and enterocele. These arms, if too tight, may pull and
cause pain.


Some of the complications that have been reported, may also be secondary to the blind
needle passes through the buttock cheeks (in the posterior compartment) causing rectal
injury and/or bleeding issues, or secondary to the apical mesh arms healing under tension
through the pelvic sidewall muscles up near the ischial spines. If the arms are too tight, it
can pull on the muscles or create a tight “band” in the vagina. If this happens then this
can cause generalized pelvic and/or vaginal pain and also pain with intercourse
(dyspareunia). Typically these complications can be handled, however in many cases the
patient must go to an advanced pelvic surgeon with experience in these type of
complications to get adequate treatment. Additionally many surgeons also felt the the
support of the top of the vagina at the level of the ischial spines was not adequate for
higher grade or more severe prolapse. Because of this, and of course because we are
always seeking improvements in our procedures, improvements and modifications have
been made to the systems to help reduce or eliminate some of these risks.




Elevate- Posterior and Apical support system
               For Rectocele, Enterocele and Vault Prolapse




              Posterior Elevate Procedure-Modification of Apogee

                       - 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 (AUGS 2009 Propel V study- need link here), 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.




Figure 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 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 (link
to vaginal mesh paper here).

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). 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).

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.
Elevate- Anterior and Apical support system
    For Cystocele and Vault Prolapse




Cystocele is caused by a defect in the support tissue of the anterior vaginal wall (ie the
pubocervical fascia) which causes the bladder to drop or “fall” down. In many cases the
uterus (or top of vagina if the patient has had a hysterectomy) falls with the bladder. This
is called vaginal vault prolapse. If this is not repaired at the same time as the cystocele,
failure can occur. The use of a mesh graft to repair cystoceles has been shown by a
recent Cochrane review to be beneficial and have a lower failure rate compared to when a
graft is not used (for more detailed explanation of this see above in the Posterior Elevate
section or click here for a more detailed background of the Anterior Elevate procedure).
The Perigee procedure was developed as a minimally invasive technique to place an
anterior wall graft in cystocele repair. Dr Moore and Miklos have been performing this
procedure for > 5 yrs and have taught the procedure throughout the world. They have also
published multiple papers on the technique and their results and had excellent clinical
results. However, procedures can always be improved. The Perigee procedure (as well as
similar procedures such as the Prolift, Avaulta, etc) utilize needles that are passed
through the groins and the transobturator space to help get the graft in place. The graft
has 4 arms coming off of it that the needles are used to attached the arms/graft to the
pelvic sidewalls. Complications can occur with this blind needle passage or in some
patients the arms can heal too tight and this can cause pain. Several years ago, the Mini-
sling was developed to help minimize risks of blind needle passes, ie a sling for urinary
leakage could be placed through one small incision with no needle passes (click here for
Dr Moore’s/Miklos recent paper on Minisling). Clinical cure rates for this procedure have
been excellent, therefore the same technology has been utilized in the modification of the
Perigee procedure and development of the Elevate procedure to treat cystocele and vault
prolapse in one procedure.
Note the needle passes through the groins required for the placement of the Perigee
procedure above.




         Anterior Elevate Procedure-Modification of Perigee

                      - 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




Procedure

The Anterior Elevate 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 small incision is made vaginally and the bladder dissected away from the vagina. The
sacrospinous ligaments are isolated and the apical arms are attached to the ligaments with
the least invasive techology available to date.
Once the apical arms are in place, the bladder neck arms are attached to the sidewalls, the
upper portion of the graft slid over the arms attached to the sacrospinous ligaments and
adjusted into place. The excess mesh on the upper arms are excised and the vaginal
incision closed. A foley catheter and vaginal packing is placed and removed the next
morning prior to discharge from the hospital..




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)


Results and Complications

Dr. Moore and Miklos have been experiencing excellent results using this modification of
a minimally invasive technique for cystocele repair combined with vaginal vault
suspension. 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).

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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