Avesta Vault Suspension

Good morning. Thank you very much for showing up at this time of morning. I’m astounded at the number of people here, the buzz. It’s terrific. I think Karen emphasized the importance of pelvic floor support. I view this particular product as an aid to predominantly prophylactic support of the vault post hysterectomy, to some degree post supracervical hysterectomy, and finally for those individuals who do have some vault support problems, who are not having a hysterectomy. I think it is a problem. It’s something that we all see. But it’s an area that we don’t understand the real problem, because the knowledge may not available to us. We’re trying to recreate anatomy that may or may not be recreatable per se. 

I think the most important literature that has come along regarding vault support, post hysterectomy are three studies out of the Mayo Clinic conducted over the last 50 years or so. They are really very good studies. They are ongoing case control studies. The Mayo Clinic was able to study patients that had hysterectomies over long periods of time with good access to follow-up. Basically, what they found was that from 1950 to 1957 those individuals who underwent hysterectomy had an incidence of vault support problems of 25%. 

At that point in time, McCall, in association with a number of other physicians at the Mayo, instituted the McCall’s or high McCall’s culdoplasty. What we’re seeing here is the so-called Avesta procedure. It’s not something that’s new. It is in essence an attempt, as we do many, many times in laparoscopy to recreate a procedure that has tried and true data, so we can do it in a fashion that’s less morbid for the patient. When McCall introduced his high McCall’s culdoplasty, which in essence is a shortening in the uterosacral ligamental structure, in a second 7-year period, the incidence of vault support problems dropped from that 25% to 6%. Finally, in another longer study from 1976 to 1987, the incidence was found to be 5%. We’ve got a procedure that has data. It’s tried and true. All of the procedures done at the Mayo were performed using absorbable sutures. We don’t use them anymore, so we may even be able to reduce that number down to something less than the 5% number that they arrived at. I think that’s the important thing, and one of the things I wanted to drive home with regard to this procedure this morning. 
The techniques as you’ve seen now. A couple of people are applying the technique. In the Mayo procedure, multiple sutures are used. The key is you’re trying to actually advance the vagina or the posterior vaginal vault over the uterosacral ligaments. What we’re seeing and what we’re actually doing in this procedure is actually shortening that uterosacral and in so doing, advancing the vagina. If you want to get more complex and make your repairs more effective, you have to go down further. We talked about that in the lab the other day. It’s something we can discuss: how you can get down further on the uterosacral ligaments or distal on the uterosacral ligaments and how you might be able to make your support sutures better.

As stated, the Mayo procedures were all done with absorbable sutures. We’re recommending nonabsorbable sutures. I think the easiest one to work with is braided Teflon or Ethibond. You can have a little trouble if you use Gore-Tex or those types of suture in that they will not reepithelialize over as rapidly as Ethibond does. If you’ve got Ethibond on tension, you will get reepithelialization within 48 hours even if you are intravaginal with the suture.

Again, I think the key is to pay attention to the normal vaginal axis without trying to “over correct”. We also recommend that urethrolysis be performed - as you saw Jim (Presthus MD) do very nicely in his procedure - or that you make a relaxing incision in the peritoneum over the uterosacral ligaments. That does two things for you. One, it allows you to know where the ureter is. Secondly, when you tie those sutures up, if you haven’t made that incision, sometimes you can get urethral kinking. That can be of course be a problem.

You’ve seen the trocar sites. The basis is you have to have these two lateral sites. For doing hysterectomy, I routinely have a larger site (10–12) midline. So we’re normally using a four-trocar position. You can of course do the procedure with two 5 mm trocars, as you’ll see in the video. But once again you need to place trocars laterally, because it seems to be the safest and easiest way to get these needles through those tissues. 

Again, recognition of the uterosacral complex can be quite simple. But after the uterus and cervix are removed or after a cervical procedure, it can sometimes be quite daunting to recognize the uterosacrals. That’s the reason we recommend opening this peritoneum and making sure you know where ureter is. Sometimes, and almost always when I do the procedure, I’ll have my assistant pushing the cervix or pulling the cervix upward toward the anterior abdominal wall to further demonstrate these ligamented structures. Again this is what you saw Jim doing. We’ll pick out the peritoneal surface and make an incision. This allows the ureter to fall out a little laterally. We’ll take this incision down to the uterosacral, and this allows us to work aggressively with the uterosacral ligament and not have to worry about that. Again all of our patients undergoing LSH or LH - the vast majority of my patients undergo LSH - have prophylactic support performed. At this point in time in our series, no recurrent prolapse has been seen- specifically in those patients who are having prophylactic procedures performed. In patients who have vaginal prolapse for other reasons, I think there can be individuals in whom you can’t get adequately get sufficient uterosacral tissue to work with. Morbidity with the procedure is basically is nil. We don’t see anybody who has real problems with this as long as you don’t have a kinked ureter. Again you can obviate that by proceeding as we have stated.

Let’s look at the video, and then we’ll come back to a couple of slides. 

This is a patient who has a fairly large uterus. You can see it’s somewhere in the neighborhood of 16–18 weeks. In this particular case, the patient has had a supracervical hysterectomy. I find that it’s easiest to work with the grasper on the opposite side. That allows you to penetrate the ligament much more effectively in general. As Jim says, he takes the suture through with the device. I find it is much easer to penetrate these ligamental structures with the bare needle. Again holding the tissue very tightly, so it’s also demonstrating the ligament clearly and using a backstop for the insertion of the needle, I then just simply pulling the suture through and through. 

These patients do not have prolapse at the time. This is a prophylactic procedure. The vast majority of our patients don’t already have significant prolapse. Of course patients who already have significant prolapse require multiple defect repair, site-specific type repair. This is simply vault support. Vault support, is of course considered one of the significant morbidities of hysterectomy in general. So, we want these patients to have good vault support post hysterectomy, and that’s predominantly where I’m using this procedure. 

See the cervix is closed. See how the uterosacral arches are demonstrated. We tighten this down nicely. If you have someone who has significant vault prolapse, you’ll want get the furthest most suture down further and further in the vagina to do better and better vault support for that patient. 

This patient has nice demonstrable uterosacrals. Again, this is just a good prophylactic procedure for this patient. It’s something that I was trained to do whenever I did hysterectomy, and that I want to continue to do with laparoscopic hysterectomy. That’s my expensive scissors. It’s a YAG laser.

Again from the opposite side. I agree totally with Jim, that you have to be prepared to do this procedure from each side. Grasping the ligament, demonstrating the ligament clearly to you. We’re using the midline trocar to just push this through. Pushing with the opposite grasper can sometimes be very helpful as far as getting through this tissue.

I think there are going to be improvements in this device from the standpoint of the amount of pressure that is required to move the needle through the tissue. It’s something we’re working on. But you can certainly easily enough get it done in this case. I like to put this as high on the uterosacral as possible. That’s going to give you the maximum amount of shortening on the ligament and it will be quite effective in that regard.

Now, we’re putting the final pass in up near the insertion of the ligament. As I’ve said, if you want to do a better and better vault support, what you want to do is open the peritoneum here and slide up. We’re going to the vaginal cul-de-sac and place the needle there. It’s easily done and quite easily done in total laparoscopic hysterectomy. I think the key when you look at this is that you get a very anatomically sound basis. The vagina is in the correct axis. All you’ve done is anatomically shorten these ligaments, which in essence is going to improve this patient’s support. You’re using a permanent suture, so that should be something that’s going to last in that patient indefinitely.

Let’s go back to the slides, hopefully.

Again, a couple of things just to remember: There can certainly be failures and complications with this. You have to remember the axis. One of the things you don’t want to do is to try and go higher and higher towards the sacral promontory. That’s not where you belong, and you will get into trouble in that regard. 

The nice part about this is too, if the patient has an enterocele defect, that defect needs to be repaired. Continuity of the anterior and posterior support to the fascia has to first be established, then do the vault support. This is a vault support procedure. This is not an enterocele corrective procedure. You don’t have to worry about foreign material there. Each of these patients has, or can have stress incontinence, if they have significant prolapse. If you have corrected the prolapse, maybe your problems will be solved. Other defect repairs may be indicated. Unlike sacral culpopexy, you will not run into sacral radiculopathy. Almost everybody that has sacral culpopexy has a problem - for a short period of time admittedly. But it always worries you. It’s a simple procedure. It’s been done before. It’s proven. That’s the most important factor here. It’s very important to remember that the goal of pelvic, of any kind of pelvic floor support surgery you’re doing, is to try to restore the anatomy. We don’t want to try to make something that wasn’t there before. We just want to restore the anatomy back to where it was. Thereby, you’re optimizing the function of those tissues. Now we can do this in a minimally invasive manner. You are going to reduce the patient’s morbidity.

Thank you very much.