Presentations from the 34th Clinical Meeting of the AAGL Advancing Minimally Invasive Gynecology Worldwide held November 2005 in Chicago, IL, USA
Office Ablation with the NovaSureŽ System
John D. Bertrand, MD, FACOG
Director of Reproductive Surgery
Presbyterian Hospital
Dallas, TX
I really want to thank our two presenters today whom we have heard, Dr. Purdon and Dr. Anderson, for those excellent presentations. I believe that if I was walking into the room cold, from what I heard from Dr. Anderson tonight, it would definitely have tweaked my interest in endometrial ablation. As we have heard, what happens with abnormal uterine bleeding and we have heard why endometrial ablation, I would like to share with you some thoughts tonight that will hopefully help you in your practice and, most of all, your patients.
We saw that figure today that 4.5 million are not seeking therapy. It may change because now they can do this in the office and I think each of you will see this and think about incorporating it in your office setting.
I have the privilege of practicing in Dallas and I am entering my 27th year of practice at Presbyterian Hospital there and that is the Fogelson Center which Greer Garson and her husband donated to us and we use it for continuing medical education and this has been, along with the Institute of Minimally Invasive Technology there, a real gift for all of us and for students and colleagues to learn and progress.
With all of the global techniques from which to choose, when we think of taking it to the office, why should we choose NovaSure? I chose NovaSure after being familiar with all of the techniques is, one, it took 90 seconds. You did not have to have two physicians, you had to have minimal work-up, it was suction on the uterus instead of distension on the uterus and it just made sense. I remember the call from Jay Cooper and he said, John, we have a procedure now, other modalities had been out a little bit earlier, now we have a procedure that takes 90 seconds on average, and that really tweaked my interest.
For the pre-op visit, I use a vaginal sonography, an endometrial biopsy, minimal laboratory, maybe some thyroid functions and a CBC and a Pap test.
We have seen this patient, we have determined that they have abnormal uterine bleeding, we have determined the procedure is appropriate, so we are going to skip the work-up and let's get right down to it: this patient needs an ablation, she is ready for it, you have scheduled her in your office for it, what happens? On the day of the operation, after their breakfast, they have some ibuprofen. The slide used to have Vioxx, but I took it off because you can another type of ibuprofen now, but some type of ibuprofen. For the remainder of the day, clear liquids. Early on in the study, and there are about 80 patients in this study, we used laminaria. About halfway through, we changed to Cytotec, so I will say that every time laminaria pops up in the slides. We use 200 mg of Cytotec, but early on, we used a very thin laminaria in the morning. The procedure was scheduled for that afternoon. Now, whether you use Cytotec or a laminaria, you need about a six-hour interval from the time you have used either. One hour prior to the procedure at home, they took something to help them relax, like 5 mg to 10 mg of Valium and hydrocodone, so by the time they get to the office; they are somewhat sedated and somewhat relaxed, hopefully.
The procedure proceeded with a cervical prep, not a full prep of the perineum, but a sponge stick with some betadine, prepping the vagina and the cervix. If a laminaria had been inserted, it was then removed. Of course, if Cytotec was utilized, it was not. I used an old Jay Cooper technique, with a cc at 12:00 so that it blocks the feeling of the tenaculum and then a paracervical block with 8 cc, usually at 3:00, 6:00, 9:00 and 12:00, 2 cc. Insertion of the NovaSure device after dilatation of the cervix and rather than Hager dilators, I like to use Pratt dilators, and if you are gentle and you talk, you can get close to 7 mm or 8 mm and usually there is not a problem with the paracervical block. Insertion of the NovaSure device and the determination of the width with deployment then ensues. Prior to dilatation, I use a pipelle to measure the inter-cervical canal and the total length of the cavity. With a subtraction of the inter-cervical length from the total length of the cavity, you can then determine the cavity length and set the controller for both the cavity width and the cavity length.
The cavity integrity assessment then ensues, giving you comfort that there is no perforation. Early on, I mentioned that Cytotec was much better than the laminaria, as we had some challenges with seals and infrequently would have to use a double-clamping technique or double-tenaculum technique when the laminaria was used. With the Cytotec, that is not a problem now. The activation of the cycle then ensued and averaged approximately 90 seconds. As you know, it will not go longer than two minutes as another added safety device. The device was then disengaged and removed.
Now, let's talk about anesthesia protocols and different things that we have used and which have evolved. Most of the anesthesia protocols you use in the office, and this was my main interest, if I want to do this in the office, what do I do? I looked at the Australian experience, I looked at the Canadian experience, and they were all a combination of anti-inflammatories, ibuprofen-type drugs, hydro- or oxycodone and benzodiazepine mixed together, and they were all a little bit different. Most of the regimens encouraged ibuprofen prior to the procedure. For example, 24 hours prior, sometimes as much as a couple days prior, and then a day or two post-op. The Canadian study I looked at used Vicodin and Valium an hour prior to the protocol and I incorporated that in my initial study. The paracervical block, I have a slide coming up, that shows, I am sure everyone in here has their own paracervical regimen they use, but I will show you some of the different regimens. I used 8 cc of the 1% and I have had some experience with LEEP procedures and we are all governed by our experience, I had some experience with some vagal episodes and some tachycardias with epinephrine even though it helps with bleeding, so I like to use it without epinephrine. The Vicodin was taken, of course, before they arrived.
Another anesthesia consideration out of Australia used Motrin, 800 mg, every 8 hours for the 24 hours prior and then again you use Valium and hydrocodone an hour prior.
As we were looking at office protocols and we looked at the paracervical regimens, they were varied. I just put this up here and it is in the syllabus that was mailed to you, but in this symposium we put together, all of the different regimens are listed. There you have 7.5 mg of Xylocaine mixed with Marcaine with epinephrine. Then you have 4.5 mg of Mepivacaine, which is diluted, then Xylocaine, a two-quadrant block. Then kilograms in measuring the Xylocaine added to saline in a paracervical block, including the utero-sacral ligaments.
Vocal-local is used and I am going to tell you why you do this in the office and if you are using the regimen that we have just spoken of, vocal-local is important: you talk to the patient and you talk them through. Some people put on soft music and then some have gone to the point of putting an IV in with a touch of Fentanyl.
I have progressed to the office now after the first 35 cases, I believe, to a different regimen. I like, as Dr. Anderson, a CRNA present with me now and I think was spurred by my own, and I will reveal another secret to you tonight, colonoscopy experience. Yes, don't shake your head like you have not had one. But I found the beauty of Propofol upon waking and recovery and knowing that they have done this in that kind of a procedural room setting for a long time and knowing that my oral surgery buddies have been doing that for third molars for a long time, I said, well, why should I not do that? So you get with your CRNA or your anesthesiologist buddy and I did not put dosages down here because he would not let me, he said it was a secret. No, it is not a secret, but it varies with each different patient. The patient comes into the room and they position themselves, they undergo the prep, I do not use a paracervical with this regimen. I go ahead and tell the anesthesiologist to start. At that time, and they are fully monitored, he has a nice little cart which they bring in themselves. They leave it with us in the office now, but most of the anesthesiologists have these traveling carts, and he gives her a combo of Versed, Fentanyl and, because of the expense, we have gone to Phenergan instead of Zofran - when Zofran becomes a little cheaper, we might go back - but Phenergan works very nicely, and Toradol. The patient usually does well with the placement of the tenaculum with that; in fact, they usually do not feel it. As we start to dilate, we can tell if we need a little bit more or not. Now, many times, with just the bottom four, we come to the appropriate dilatation; place the unit in and, at that time, if they are feeling any discomfort at all, the anesthesiologist of CRNA has a syringe of Propofol - wonderful. They start it just as they are talking, they start the Propofol with a vocal. When the patient gets just the right amount, then I engage the unit to measure the cavity width and go along with the cavity integrity assessment. During the procedure, you will readily see how fast Propofol is metabolized because he will stand there invariably with his anesthesia syringe and just give another tenth of a cc, another tenth of a cc, just enough to keep the patient right under. The procedure started and, again, we are talking about 90 seconds, and it is not until maybe the last 20 or 30 seconds of the procedure in some individuals where you may see a grimace or a moan or a reaction with the curling of toes or whatever and, at that point, a little more Propofol is given. The procedure continues like that, it's over, she moves herself off, it is just amazing how fast Propofol is metabolized and basically after that, she will awaken and go into the recovery area.
Additional considerations are summary, think of Toradol; think of ibuprofen, which includes Motrin, Advil. I learned from our President of the AAGL that he uses Benadryl and you will read about that and he uses it because he thinks it is the most effective post-operative sedation that is available. You will develop your own regimen. I do not use that.
Post-operative in the recovery area, patients are observed for about 20 to 25 minutes, blood pressure and pulse readings, we have a nurse or medical assistant with them, they are discharged, usually all of them, within 30 minutes. We do not let them drive themselves obviously, they have to have someone waiting for them and for the first 48 hours, I tell them about every 6 hours to use Advil or some type of ibuprofen and then I do a post-op check. I used to do just a phone call but I feel more comfortable eye-balling the patient when they come back in two weeks to just see how they are doing. Frequently, if they are doing fine, I do not even do a pelvic exam, but I just talk with them. You can examine them if you like, but we just have not seen any problems. We used to examine all of the patients, early on in the early '80s, we would sound all the cavities, make sure we were not creating a trapping of blood or debris in the uterus. With the global ablative technique and the NovaSure device, it is just not necessary.
Pain levels we had. If you look at this slide, the same number, but the majority of patients were under a level 6 out of a level of 10. They were asked on their little cards to equate what their pain level was. The majority of patients were 3 or less and remember, half of these patients, only the last 20 some-odd were done with Propofol. The one patient who had an 8 happened to be the rep's next-door neighbor. I will never forget it. She had a retroflexed uterus, we had to turn the machine off three times to get through it, it was very unusual. But, for the most part, you see those numbers, a few went up to 6 and I think because of that, I like the CRNA and the newer regimen. But definitely, it can be done.
Bleeding-wise, 99% of these patients bled normally or less; 55% were amenorrhagic.
So as you are sitting in the office and interviewing your patients, how do you judge which ones are appropriate to bring in? I should have perhaps a slide that just has airway. If you are looking at a 350-pound patient with no neck, do not do her in the office. We are prepared, we have the little Banyan kit, we can intubate there, and we have people who can do that, but that may be the patient to take to the hospital. So if she has any kind of an airway challenge, that may not be what you want to do in the office. Has she had a prior vaginal delivery? When you did the endometrial biopsy with the pipelle, did she not feel it, was it minor discomfort or was she crawling on the ceiling? Maybe that person would not be appropriate. Of course, with Propofol, maybe that would be okay. Remember, I cannot emphasize Cytotec enough. It has been a real blessing for us in this procedure: 200 micrograms the night before because we do theses in the morning now, or in the morning if we are doing it in the afternoon, makes the dilatation extremely easy and even if they have had c-sections, no vaginal deliveries, it is still possible and most of you here have experienced Cytotec and know that it really is an enabler. It minimizes perforation complications and just eases the device insertion.
Use ibuprofen and real expectations: tell the patient that your goal is an acceptable period; amenorrhea is a bonus, under-commit and over-deliver to your patients.
We can safely do this in the office. 4.5 million women not seeking treatment for this. Maybe if we can say this to them, this will be an enabler for them to get the treatment they need and deserve.
We can safely do this in the office. 4.5 million women not seeking treatment for this. Maybe if we can say this to them, this will be an enabler for them to get the treatment they need and deserve.
What is the future? Well, the future is today. You have obviously seen that this is a do-able thing. You get reimbursed for it; for once, you start getting paid for your time again. It is a problem. We need a procedure room in our offices. One of your rooms needs to be converted. If you are building an office, it needs to be built and it needs to be a procedure room, not an ASC, but just a procedure room in your office for ablative procedures, tubal plugging, office hysteroscopy, LEEP procedures and other things can be done. Anesthesia needs to be something that you are now comfortable with in the office, whether it is local and oral or whether it is IV sedation with monitoring.
Our conclusion: NovaSure is safe, simple and effective. NovaSure complements, it is definitely a complement to the procedure that is done in the ASC or the hospital that can now be done in your office.
Thank you very much for your time.