In this "in-between-isode" of our podcast Anamnesis, 乌鸦传媒's Editor-in-Chief Marty Makary, MD, MPH, interviews Ali Ghomi, MD, a gynecologic surgeon in Buffalo, New York. Ghomi says a quarter of the hysterectomies he performs each year are to treat post-ablation syndrome.
This interview is also a video if you'd prefer to watch the discussion. Here's a transcript of their conversation:
Marty Makary, MD, MPH: Dr. Ghomi, it's Marty Makary, good talking with you here. Thanks for coming on the show.
Ali Ghomi, MD: Sure.
Makary: Tell me about this endometrial ablation controversy.
Ghomi: My practice is exclusively gynecologic surgery, focusing on robotic approach and laparoscopy. I do a high volume of hysterectomies, pelvic reconstruction, endometriosis.
Makary: Do you see a lot of patients with heavy bleeding or abdominal pain?
Ghomi: Correct. So that is a big portion of gynecologic surgery, patients who suffer from symptomatic fibroids, adhesions, pelvic pain, endometriosis, and something that is referred to commonly as post-ablation syndrome.
Makary: If this procedure, endometrial ablation, has been around for a long time, how has it evolved? In the early days, was it more a thermal ablation and has it matured now to do radiofrequency and other forms of ablation?
Ghomi: Yes, absolutely. Back in the '80s, we used to use a device called a resectoscope. It's a device that is introduced through the cervix and you essentially resect the lining of the uterus, which is called the endometrium, to address the bleeding. Then back in the 90s, the devices called global endometrial ablations, the non-hysteroscopic methods, became very popular. It was touted as having less complications in terms of fluid management associated with the system.
Makary: When you say non-hysteroscopic, in other words, there's no visualization. This device is placed in directly into the uterus and then it's turned on to ablate in whatever way it does?
Ghomi: Absolutely, yes. These are catheter-like devices, and the tip of which carries different types of modalities of energy sources from radiofrequency to electric to heated water -- all of which is essentially intended to destroy the lining of the uterus -- where essentially the endometrium gets shed and results in heavy bleeding in pathologic situations.
Makary: Is heavy bleeding the primary indication for this procedure?
Ghomi: Absolutely. The primary indication is dysfunctional uterine bleeding, abnormal uterine bleeding without any structural findings. In other words, you should not be having any fibroids, significant distortion of the uterus. The size has to be a relatively normal size uterus. You kind of don't want to see any organic or abnormal pathology. Essentially, these uteri just cause heavy vaginal bleeding -- the so-called menorrhagia -- and I must also say that one of the other main indications is the patient should be relatively pain free. Because if they are in pain, that might signify other conditions that might be going on.
Makary: Now, the FDA reports through the MAUDE database from investigative work that's been performed here that there's over 500 patients that have had serious complications of perforation. Now we all know the MAUDE database only captures maybe 5% to 10% of what's actually happening in the real world. Case in point, you and I rarely have reported something to the MAUDE database. Most doctors have never reported something to the MAUDE database, yet we probably have seen consequences that have stemmed from some device. It's just these reporting systems are not evident to us. Doctors generally don't know how. We're not instructed. So given the fact that this is representing underreporting, do you think that's too many cases?
Ghomi: It might be. Those visceral complications are the disasters that would concern any physician that would be utilizing the device. It's a very rare complication, but personally I am aware of probably two or three in my training and my career, which I've been doing this for almost 20 years. It's been reported to be less than 1%, but as you alluded to, the exact frequency of these complications probably are not well known.
Makary: Given that reporting bias, do you think the procedure is safe, and also, is it user-dependent? In other words, is the safety heavily dependent on the technique or is it more a function of the device?
Ghomi: It's actually completely user-independent, as much user-independent as possible. Essentially, the technique involves introducing the device into the uterine cavity, introducing the measurements, the dimensions of the cavity into the machine. The machine does the rest of the work. The cycle typically lasts anywhere between 30 seconds to three minutes, so it's really not a labor-intensive procedure. I think, for the most part, the complications arise after the procedure or, in rare instances such as the visceral injury, could happen during the case and go unrecognized.
I think that is the very disastrous part because you and I both know that in surgery, if you recognize a complication, you take care of it right away. The patient will do well, but the problem here is if there's a complication, if there's a thermal injury to the bowel or to the viscera that is opposing against the uterus on the other side and it goes unrecognized, then these patients might come back to the emergency room in a few days with very disastrous complications. But just to answer your question, again, for the most part, it's user independent.
Makary: Most doctors try to do the right thing or always give it their best effort, but some fraction of doctors may respond to perverse incentives or not be up on best practices. Is that one of the drivers of this ablation procedure being overused in the United States or is it underused?
Ghomi: Personally, I think it's being overused. I think the problem with that is there's absolute contraindications to the procedure, which is if there is a diagnosis of uterine cancer, for example, you're not to do the procedure, but there's a lot of relative contraindications. Those are the soft contraindications, and I think some of the doctors might still perform the procedure in these kind of circumstances.
In my opinion, that's when the failures occur, the post-ablation pains occur, the potential perforations of the uterus at the time of the surgery occur, and I think that's where the problem is. I think we have become more and more complacent when it comes to performing these procedures in recent years because of the notion that it's least invasive, it can be done as an outpatient setting, it can be done in an office setting, it doesn't have that much downsides.
I think we have to revisit what is the nature of these procedures, why these relative contraindications do exist, and lastly, I think we are not counseling the patients properly and very carefully. We can engage in the data that we have available to us in terms of the failure, the post-ablation, the percentage of patients who end up needing a hysterectomy anyway, the cost-effectiveness compared to alternative methods. I think there needs to be a re-evaluation of the whole discussion of endometrial ablation.
Makary: Now with some procedures in medicine, a small group of outliers can overuse a procedure and give it a bad reputation. We've seen this with cardiac stents. Most cardiologists do their best and try to do what is right, but a small fraction of cardiologists that overdo stents have given that field a bad reputation. Same with spine surgery or putting certain types of hardware in during procedures. Is that the case with this endometrial ablation procedure? Is there a role for it where it can help a lot of women out there, but a small fraction of people that are overdoing it may be giving this procedure a bad reputation?
Ghomi: That sounds very possible to me. I don't have the hard data. It's mostly anecdotal, but I do agree with your notion. This is very similar to cardiac stents or pelvic measures, for that matter, that if the right patients are selected in the right hands, those patients will benefit. It's only when any type of procedure is overused and the strict criteria for which the procedure is invented or has received the FDA approval, when those criteria are not carefully examined prior to offering the procedure, for example, endometrial ablation, here.
Makary: Some gyn oncologists have told me that this can be an important stop-gap measure before proceeding straight to a hysterectomy. In other words, for the right patient, this procedure can avoid the need for a hysterectomy. Some of them have pointed out the fact that this procedure may be important because we, as a country, do more hysterectomies per capita than probably any country in the world. Some have suggested we do too many hysterectomies. What are your thoughts on this intervention as a stop-gap measure or, in other words, something to try first in select patients?
Ghomi: I think there's definitely some truth to that. If you look at the data, the published evidence that we have available up to five years, only 30% of patients who receive endometrial ablation end up needing a subsequent hysterectomy. You might say that 70% of patients can avoid hysterectomy.
We have prospective, randomized trials, head-to-head between endometrial ablation and minimally invasive hysterectomy. One came from the U.K. group last year and the other one was published about 20 years ago from Italians. They have effectively demonstrated that the complications between endometrial ablation and minimally invasive hysterectomy is quite similar, and obviously hysterectomy is more effective for the patients.
That brings up the whole discussion that is minimally invasive hysterectomy truly inferior when it comes to endometrial ablation? Now, there is more evidence and more data out there that argues that, in terms of cost, maybe in the long run, the cost would be also similar because 30% of patients that end up having problems, unintended consequences, more bleeding, more workup, more surgery. I have looked at these data very carefully and I think the notion that maybe this is a stop-gap and would avoid hysterectomy, that could be true, but hysterectomy has come a long way. We're not talking about hysterectomy by laparotomy. We're talking about minimally invasive hysterectomy that can be done as an outpatient setting.
Makary: Which patients in your practice do you like to offer the endometrial ablation to?
Ghomi: If I were to offer endometrial ablation, that would be for someone who has abnormal uterine bleeding, who is premenopausal, which means that they're typically younger than 50 years of age, who have a normal size uterus without any pathology, meaning that the biopsy of the lining of the uterus is normal. Their pap smear is normal. The ultrasound does not indicate presence of any polyps or any fibroids. They have never had C-sections before, and they have never had tubal ligations before. There's no history of endometriosis or pain or significant painful periods.
That pretty much would be a classic, ideal candidate. I think the problem that we are facing right now is that type of candidate would be probably less than 1% of the patients that do receive endometrial ablation. There is data to suggest that if you have three risk factors for failure, meaning younger age, history of tubal ligation, and painful periods, the failure after endometrial ablation rises up to 60% and 70%. But I think if you choose that specific ideal candidate, endometrial ablation would be a very good procedure.
Makary: Has the company been overmarketing the device?
Ghomi: One might argue that. I think it's a combination of overmarketing, touting the fact that it's operator-independent, the fact that it can be done as an outpatient setting is another attractive piece to it.
Makary: How much does it pay?
Ghomi: To be honest, I'm not sure. Every market has its own specific reimbursement rate, but it would be quite close to a hysterectomy. It used to be, actually.
Makary: I have reimbursement data here that suggests it's about $1,100. Does that sound about right?
Ghomi: That sounds about right, yes.
Makary: And it takes about five minutes. Is that right?
Ghomi: That is right, yes.
Makary: Dr. Ghomi, if you found out that the company was asking the FDA for a lifestyle indication to simply use the ablation procedure to get rid of normal menstrual bleeding -- in other words, to market to the public that you can no longer have periods if you have this device used to ablate your endometrium -- how would you feel about that?
Ghomi: I think that would be a bad idea, Dr. Makary. Whenever you use these devices, whenever you ablate the endometrium, we now know that the endometrium continues to be functional, so it would be just a matter of time before these women would either experience failure of the procedure or significant pain as we come to understand it or coin it as post-ablation pain syndrome. We have better modalities available to us such as the progestin-releasing IUD devices. They can be inserted. It's reversible. There's really not much downside to these devices, and it's not a matter of dispute. The head-to-head comparison between the IUD versus endometrial ablation based on the available literature and data, IUD always wins. I would be very leery and skeptical about just using the endometrial ablation devices just as a means to improve lifestyle.
Makary: Thank you for that perspective. I think all of us have been struck sometimes by the tragedy of serious medical complications from lifestyle or cosmetic interventions, these things that were done purely for a lifestyle or cosmetic reason. Thank you for your perspective. Dr. Ghomi, it's great having you. Thanks for sharing your voice here.
Ghomi: I appreciate it. Thank you.