Michael Nimaroff, MD - Should we ablate or resect endometriosis?
Advancing the Science and Surgery of Endometriosis
Monday and Tuesday, April 19, 2016
The Union Club, New York
Thank you for inviting me to speak here today. Dr. Seckin, Dr. Reich and the Endometriosis Foundation, thank you very much. I recognize many fellows in the room, I am just curious, how many residents are here? We have a few. While we are setting up I am going to share that I like speaking towards the end of this program. We are going to try to keep you awake, hopefully. But also, maybe tie some things together.
I am a gyn surgeon myself but I am maybe will present in a, and I love following the last talk, I really do not have to give my talk actually. No, but I love following the last talk about the issues about when we are talking about getting what the purpose of getting pregnant that the data is very mixed about whether we need to actually operate on these patients. I think it is important that we look at this and maybe have a slightly different perspective that it is not just always excise everything, take everything out.
Before I start I just want to say I have a six plus, okay. Though you cannot fix the EMR issue, which I do not know why not, but I did not like your answer, no, no, joking. What about the battery issue? I mean I have an iWatch but of course I never charge it. I don’t wear it.
Getting back to endometriosis. Obviously one of the questions always is it is not just excision ablation but it is also let us say surgery, medical therapy. We have to always bring in – it is hard to just talk about one aspect to it but I am going to try to focus on mostly that. The videos are really less important but this is a little bit controversial. The data is really, there is very little data comparing deep infiltrating endometriosis in randomized controlled trials. There is some data on mild endometriosis. Obviously data was just presented on endometriomas and fertility and certainly we have to look at this clearly it is a chronic disease. Again, the tendency, do not shoot the messenger, but the tendency when we deal with patients who have chronic disease is we want to treat them. We want to cure them. I do not know yet that there is a cure for endometriosis. I think that is why we are here. There are different approaches to endometriosis treatment. The purpose is to alleviate the symptoms we have to address it in a way to again sometimes it is organ involvement, sometimes it is not organ involvement, you know, the primary symptom is pain. Then again, just like the last talk sometimes it is all about getting pregnant and infertility and that is the issue. We have to look at it and approach it that way.
Our options obviously are observation, empiric medical therapy, surgical treatment followed by medical treatment plus/minus. Then we have the whole issue of ablation, excision and then ultimately, hopefully we never have to get there but for some patients the answer is ultimately a hysterectomy. Whether we take the ovaries or not that is a separate thing. I am not really going to go down that path and I am not going to talk about all the different options, medical therapy, this is just something for us to talk. Obviously ablation, whether you do a laser or whether you use argon beam, obviously we have all different tools, coagulation. The story is obviously classically if we ask the residents and then again many people in the room feel that maybe ablation is not the greatest way to do it. Maybe not penetrating deep enough and certainly we should excise. We all know that we also hear more and more, I will just play this as I am talking, more and more we see physicians who feel that we should be doing on our adolescents who come in with dysmenorrhea that we should be doing robotic diagnostics scopes with Firefly because we are missing all this mild endometriosis. I am sorry I do not know that that is correct. I do not think we are necessarily doing a service to those patients. That is me. Certainly excision for deep infiltrative endometriosis patients who are unresponsive to therapy are certainly not wrong and no one is saying there is no right one answer here. I think that is the take home message.
Clearly we have to be concerned. We have to take a detailed history. What do we care about? Obviously aside from the symptoms and the patient’s past surgical history and such and her physical findings and imaging but it really is all about what is the age of the patient, what is the primary problem here, is it pain, is it fertility issues, what is the problem? I think that is really the focus that you have to use when we start talking about what is the best way to treat them.
Surgical treatment of endometriosis, again there is obviously when you research this most of this data I am presenting is really from the last three years. There are an incredible number of papers written but very few randomized controlled trials unfortunately and we are talking about this. Patients with infertility and mild disease there was no difference in fertility rates no surgery versus surgical treatment. Those with moderate to severe disease surgical treatment does improve outcome and that gets to the point that again, if you are talking about spontaneous pregnancy conceiving without intervention IVF, assisted reproduction definitely surgery does assist in those patients when we still have good tubal functioning.
Should we diagnose and treat minimal mild endometriosis before we proceed with assisted reproduction. Improvement with suppression and surgery has shown little benefit, most studies show benefit pre-IVF suppression with moderate to severe endometriosis but there is little data showing any real added benefits. The question is when we are talking about specific fertility issues, this is a patient that is already been trying to get pregnant for a year and a half, the question is should we now go and do our laparoscopic or robotic evaluation to see to what extent the disease is? Or do we go ahead and just say proceed with the ART. We are going to leave that for all of us but the data shows that it may be the way to go is let them have their assisted reproduction.
In vitro, again, this stuff we just sort of ___ in vitro fertilization successful treatment of endometriosis associated infertility. Women with endometriosis have similar success rates with IVF to women without endometriosis. Endometriomas, there was lower rates of success but certainly it is still very successful. This was on 2200 patients.
This is just redundant to the last talk, which was incredibly thorough and I think we can just skip this. The endometrioma for improving fertility, endometrioma does not appear to have a negative effect on ovarian reserve but surgery does. It has some effect, negative effect but surgery does have an effect. Again, the AMH and the antral follicles and all that. Having said that as we heard last time if we wait long enough maybe that AMH level does come back. But the clinical pregnancy rate and the live birth rates are similar and that is the whole key. The feeling from, at least this paper, again get similar to what we heard is that endometriomas greater than three centimeters should likely be removed primarily because it makes it much more difficult for them to retrieve their eggs.
Endometriosis size is an irrelevant factor. Sixty patients both ablated and excision reduced AMH levels. Cystectomy certainly, so excision definitely has a lower recurrence rate. Large endometriomas over five centimeters decrease in the AMH is greater in the excision group. Having said that do I excise the endometriomas? The answer is yes I excise endometriomas. Clearly we try to, if we leave the base, if the base is definitely attached it tends as you all know the hilam tends to be the stickiest part of our endometrioma that we will leave and ablate that part. I never thought of it being sort of a hybrid technique but basically it is. Most of the time with endometriomas, especially large ones, you do face that issue.
What about pelvic pain associated with endometriosis? Treatment of laparoscopy is certainly to help pain, by the way surgery helps the symptoms we are not saying that surgery does not help it does. But no study has shown an advantage of excision over ablation. Having said that it does not mean that if you have, you should not excise, I am not saying that but when you have patients who have mild disease the question is should you be excising and running the risk of complications? The answer is the jury is out on that. There are plenty of surgeons who think you have to excise, you have to excise, you have to excise. The answer is for mild to moderate endometriosis there is no data on it at least that I could find.
There are limited studies on medical treatment versus surgical treatment, both approaches are effective. Medical therapy for endometriosis is growing. There are more options. There are more progesterones, anti-progesterones and we are going to talk about it but, and obviously a lot of research on different therapies, and there probably will be a day that it is the advanced stage, the deep infiltrative endometriosis, that require specialized surgeons who are really experienced to do those real excisions when it is involving the bowel. Those are probably going to be the patients that will still need surgery. But for mild to moderate disease I am not so sure we will be operating on those patients in the future but we will see. Surgery followed by medical therapy definitely is something that you always have to consider and has been shown to improve the symptom free period. It is all a question about the choices that we have for our medical treatment post-op. This is for deep infiltrative endometriosis.
Meta-analysis – there are very few randomized controlled trials but many studies show an effectiveness of medical treatment. However patients with DIE require a prolonged treatment. If you have severe endometriosis and pain we are talking about very long term suppression so surgery is definitely still clearly an option. We have to make these things options. I often see patients they look at me when they come to me as a surgeon usually because I am in the network, they may see someone here, and then they come and see me because I am in the network so they drive 45 minutes out to see me. Sometimes many of them are not happy with what I tell them because I tell them they have never been on medical therapy, they have had two radical procedures and I tell them, “You know what, why don’t we see how you do on some medical therapy?” They leave because they do not want to hear that.
It is interesting and I think it is just something that I hope, especially our young physicians keep in mind that you have to bring these as options and you have to tell her what we are recommending.
This is similar. All the studies really tell a similar story but surgery works, it absolutely helps.
Excision/ablation improves spontaneous pregnancy rates over diagnostic scopes and believe it or not people are still doing just a routine diagnostic scope, seeing endometriosis and not doing anything. Pregnancy rates with excision or ablation have been shown so doing something at the time of surgery certainly helps the spontaneous pregnancy rates. Ablation improved pain treatment over diagnostic scope plus GnRH. These were multiple different studies and no difference in excision versus ablation. This is for mild to moderate disease. Certainly this was not true this study, at least I could not find, done on severe and deep advance staged endometriosis. Clearly those patients need to have excision.
This was surgery versus low dose progesterones – 154 patients they were effective in treating symptoms. There are similar studies I could go on and on. The same thing with – one of the studies that I do not think I included, really just shows the use of Mirena, the progestin IUD for patients who have severe endometriosis being effective also. This one is a randomized controlled trial of hormonal therapy versus surgery versus combined therapy and these were done with second look scopes. Sixty percent cure with the combined treatment, 55 percent with hormonal and 50 percent surgery alone. No significant difference among groups as far as pregnancy rates but again the various modalities that we have tend to be effective.
Consensus on current management – this was a World Endometriosis Society consortium in 2013 – no significant difference in outcome of excision over ablation. However excision is recommended for patients who have deep infiltrative endometriosis.
Evidence is still controversial regarding the best first line. It is felt that actually medical therapy should still be offered as an option for first line treatment. We should try it. If you do well and it depends on what your plans are, if you want to get pregnant in two months it is not going to help. If that is not the goal medical therapy is definitely an option.
Most adolescents have stage one to two disease. Due to lack of evidence a balance between appropriate treatment empirical, medical versus surgical, without over-interventional approach must be recommended. We have to remember for our young patients that the data is not really out there. It says we should be going in there and doing peritoneal stripping on all their endometriosis. It is not there yet. Maybe the studies need to be done but it is not there.
First line treatments remember are NSAIDs, OCPs or progestins and second GnRH, the progestin IUD, Danazol, depot progestins. We have aromatase inhibitors, serms and also selective progesterone receptor modulators. The list is going to continue to grow because obviously there is more and more data coming out there.
Just remember again what is the objective? Is it conception, pain, restoring organ function that is really key to what we are advising the patients. We have to address the main clinical objectives, not just the presence or absence of visible disease.