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BackTable / OBGYN / Article
Endometrial Cryoablation with Cerene: Focus on Patient Experience
Olivia Reid • Feb 8, 2024 • 54 hits
Many women continue to seek alternatives to traditionally used hysterectomies or IUDs as methods to control abnormal heavy menstrual bleeding. Endometrial ablation, specifically cryoablation with Cerene, is an option that providers and patients may want to consider.
From clinical counseling to the procedural process and long-term outcomes, doctors Barbara Levy, Mark Hoffman, and Amy Park walk through the advancing world of endometrial ablation. Moving away from older technologies, the introduction of the Cerene device for cryoablation has given patients shorter recovery periods, lower medical costs, and little to no negative side effects, according to Dr. Levy. This is due to the efficiency, size, and design of the device.
Expanded FDA criteria and three year post-procedural impact studies will continue to add to the expanding field and contribute to Dr. Levy’s prediction of a coming surge in cryoablation procedures in the office.
This article features excerpts from the BackTable OBGYN podcast. We’ve provided the highlight reel in this article, but you can listen to the full podcast below.
The BackTable OBGYN Brief
• The expansion of FDA inclusion criteria from ovulatory patients with a normal-size uterus and no fibroids to patients with small fibroids and some polyps has increased the accessibility of endometrial ablation.
• The Cerene device for cryoablation allows for quicker procedures, lower overall cost, and decreased side effects for patients when compared to other heat technologies and prior endometrial ablation techniques, according to Dr. Levy.
• Current published data regarding the success of Cerene goes out to three years, yet there are patients who have comfortably reached six years post procedure with limited to no reported complications.
• Due to the long-term and multifaceted impacts of contraceptives, patients should be offered reproductive choices beyond traditional sterilization methods to help them preserve their reproductive autonomy.
Table of Contents
(1) Clinical Counseling on Endometrial Cryoablation
(2) In-Office Endometrial Ablation with the Cerene Cryotherapy Device
(3) Long-Term Efficacy of Endometrial Cryoablation & Its Role in Unique Patient Populations
Clinical Counseling on Endometrial Cryoablation
Dr. Levy explains how the expansion of the FDA’s approved indications for endometrial ablation has opened many doors for patients who were culturally opposed to an intrauterine (IUD) device-the current alternative to endometrial ablation-or fearful of an IUD due to common misconceptions about its side effects. Dr. Hoffman adds to this, highlighting that many patients come into the office more anxious over the placement of an IUD than a hysterectomy because of misinformation comparing the two. These myths emphasize the need for effective patient counseling on the risk-benefit balance of procedures prior to their execution.
Further, many patients believe that amenorrhea is the end result of an endometrial ablation, leading to hesitancy and avoidance of the procedure, when in reality, the goal of ablation is a reduction to normal or slightly less than normal cycles, not the absence of bleeding. Reducing the circulation of myths and false perceptions will decrease the performance of unnecessary medical procedures and provide patients with the results that they are searching for instead of long-term negative outcomes.
[Dr. Amy Park]
The cyclic pain with the persistent endometrial tissue at the cornua and the dilating up the tubes causing these hematocele pains. It's pretty painful and causes a lot of discomfort. I just remember going, "Well, I'm not sure," and then a lot of obese patients were getting it, and that was the contraindication. I agree with Mark. I just saw a lot of patients coming through. It seemed like, "Why not just get an IUD and then hysterectomy?"
[Dr. Barbara Levy]
Remember that in the early days of endometrial ablation, the Mirena IUD, the levonorgestrel IUD didn't exist. That came along later and absolutely in my practice, I would 100% recommend to patients that-- because you still need permanent contraception if you're going to have an ablation. To me, the first line of treatment was always to think about a levonorgestrel IUD for sure.
That said, I will say that the other thing that happened across the years is that the strict criteria that FDA originally used for the pivotal trials, ovulatory patients with a normal-size uterus and no fibroids got expanded. They got expanded now to small fibroids and maybe some polyps. Then some of the studies did not require that the patients were ovulatory and that's where we really start to get into trouble because now you've got patients who are at least somewhat anovulatory and at risk long-term for hyperplasia or endometrial cancer.
Now, there were thought leaders who said, "Well, if I destroy the whole endometrium then we're reducing their risk of endometrial cancer." Most of us were saying, "Yes, but you never really destroy the entire endometrium. Does that cancer actually start from the superficial or does it start from the basalis?" Who knew? What happened was, of course, this industry does what industry does, they start promoting this and expanding the indications for doing this procedure.
Patients loved the idea of no hormones. It was a way of sucking women in. Then one or two of the companies really started pushing amenorrhea as the endpoint and the thing that was really meaningful. Most studies, in fact, every study that I'm aware of that asks women what they want, they want a return to normal or a little bit less than normal. Amenorrhea is not an endpoint that most women in focus groups and other things are looking for. In fact, culturally, some women absolutely do not want amenorrhea. In my practice, Amy, there were women culturally who would not have a foreign body in their uterus. IUD is not an acceptable form of treatment for a certain population of people.
[Dr. Mark Hoffman]
There's a lot of patients in my practice who the idea of an IUD scares them. I'll have patients who have unbelievably long lists of terrible medical comorbidities and dozens of surgeries and they go, "Oh, well, an IUD scares me more than a hysterectomy." I said, "Well, then my job is to educate you to the point where you're more scared of the hysterectomy than the IUD because it is amazing how--" Again, we're education. We're not journalistic. We want to make sure we inform our patients, but I do think the other thing with education, as it relates to endometrial ablation, is I have a lot of patients that come see me that, "Well, I was told I wouldn't have periods." The counseling is not what the device manufacturers recommend, what any of the evidence suggests that people want, nor is it the thing that any of the studies are looking for which is reduced bleeding or amenorrhea. Amenorrhea is sometimes a side effect and patients are going, "Well, I didn't want to have a period anymore." I said, "Well, but then your doctor shouldn't have told you you weren't going to have the periods."
[Dr. Barbara Levy]
That is not appropriate counseling for the Mirena IUD or the levonorgestrel IUD, nor is it appropriate counseling for endometrial ablation. If a patient really wants guaranteed amenorrhea, the only way we can guarantee that is with a hysterectomy. I was very clear with my patients about that.
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In-Office Endometrial Ablation with the Cerene Cryotherapy Device
With the surge of the use of the levonorgestrel IUD, traditional methods of endometrial ablation procedures have declined in popularity. However, Dr. Levy predicts a resurgence with the advent of an efficient cryoablation device like Cerene. With cryoablation, the patient comes in for a fifteen minute office visit and can return home to normal activities immediately, allowing for lifestyle flexibility and decreased overall cost. This is because there is no additional cost, apart from the standard co-pay, for an in-office procedure when compared to having to visit a hospital or other outpatient facility.
Performing a cryoablation involves the use of a single, handheld Cerene device containing a canister of gas measuring about 5.5 millimeters total, which is comparable to the size of an IUD. To begin the procedure, a liner is deployed which conforms to the shape of the uterus. With the use of the gas canister, the pressure is increased slowly, allowing for the lining to conform even to an irregularly shaped uterus or polyp. As the gas continues to increase both the pressure and temperature slowly, the patient most often reports feeling no discomfort or limited discomfort throughout the seven minute procedure. When comparing cryoablation to previously used heat technologies and even IUD placement, it has been found that patients do not experience the 24-48 hours of pain resulting from many heat technologies, or the cramping from an IUD after a standard cryoablation procedure with the use of Cerene technology.
[Dr. Amy Park]
Just for my knowledge in terms of the popularity and uptake of endometrial ablation and who's doing it, what is your sense, or what do the stats stay? I don't know.
[Dr. Barbara Levy]
Yes. It has declined with the increasing use of the levonorgestrel IUD. It's definitely not in its heyday as it was, although there's a lot of new technology out there. I think that it's been relatively stable. These numbers are hard to come by because even the Medicare database isn't going to help us at all, the Medicaid database isn't going to help us at all. We have to look at all payer databases, which are really expensive to try to get a handle on it. It looks like somewhere around a couple of 100,000 cases a year.
I think that if cryoablation really takes hold and people recognize that they can do a procedure in a 15-minute office slot with no additional help and the patient is comfortable and goes home right away and goes back to normal activities, that probably will drive more because the threshold for a patient, the cost to a patient to go to an outpatient facility, whether it's an ASC or an outpatient hospital facility is going to be substantial. They have a percentage of total cost that they will have to pay versus a $25 or $35 copay in the office and that's it. There's a big cost difference for patients and I think there's also that threshold. If you're going into the hospital and you're having an anesthetic, I would be a little antsy about that versus being in your own physician's office where you have a comfort level and could have a procedure that's not more really than putting in an IUD.
[Dr. Mark Hoffman]
You're saying with cryoablation, that's something that I’ve not seen done in my practice. It's not something I've seen in training. It's obviously something new that we're here to talk about a little bit but talk to us a little bit about the device. I think Cerene is what we're talking about, because yes, endometrial ablation is in the OR in my practice. It is something we are not doing in the office. We're not talking about doing in the office, whether it's at the ASC or OR, people are undergoing anesthesia, there's a recovery period and what you're saying. I've read a little bit about it, but I'm not very well versed on cryoablation or the new devices coming out, but talk to me about what it is, how it works, are we dilating, all those things. Just walk us through how this procedure gets done.
[Dr. Barbara Levy]
First of all, it's a handheld device with no capital equipment required. There's no big generator or something to purchase. It's all a self-contained single unit. It has a canister of gas. So, what happens is the patient comes in, we do our usual, "Hello, how are you?" and we've already talked to her about endometrial ablation, so she's prepared. If she is someone who has irregular periods, we're going to want to treat her at the follicular phase or with a thickened endometrium. You really want that endometrium to be at an early follicular phase in terms of thickness. The device itself is about 5.5 millimeters, so it's about the same as the IUD in terms of dilation.
It is deployed, you measure the cavity, it deploys a liner that conforms to the shape of the uterus. It can conform around a polyp or in an irregularly shaped uterus. It's like a balloon, they call it a liner because, unlike a balloon, it's not round. It actually uses a very slow increase in gas pressure to conform to the irregularities in the lining of the uterus. It's amazing. They've got this all mindless. It's all in the handpiece. It tells you what to do, what's the next step, and tests for integrity of the uterus to make sure that the uterus is intact. Then, it slowly increases this gas pressure so that she's not feeling a sudden onset of pressure. As the gas expands, it cools. It gets to maximum temperature or minimum temperature quite quickly. The entire procedure is about seven minutes.
Patients tell me that they have less discomfort than with the placement of an IUD because they don't get that cramping. Most of the docs who were doing the pivotal trial used NSAIDs rather than a paracervical block. If people are used to doing a paracervical block for an IUD, I would say do it. I would say for multiparous vaginal delivery patients who have an OS that's accessible and pretty easy, probably not necessary. For somebody who's had four C-sections, you probably want to do a paracervical block because you may have some trouble dilating. Some used NSAIDs and that's it in terms of pretreatment for the patients.
It is also the original cryoablation procedure. Remember the ice ball, Her Option, had within the code ultrasound guidance because you had to have ultrasound guidance for that procedure. To use that code without a modifier, putting a transabdominal ultrasound probe just to make sure that you're in the right place or you're aiming correctly in a retroverted or anteverted uterus allows you to use that cryoablation with ultrasound guidance code that's been in existence for a long time. The patients are very comfortable.
Long-Term Efficacy of Endometrial Cryoablation & Its Role in Unique Patient Populations
With the increased use of endometrial ablation technologies, specifically cryoablation, there are many questions regarding the long-term effects on patients undergoing these procedures. Dr. Levy relays that the current published data extends up to three years post-procedure, however, there are patients who have comfortably reached six years with durable symptom relief. Further, Dr. Hoffman suggests potentially studying patient populations who may need to undergo repeat ablation with the handheld cryoablation device in the case of continued abnormal bleeding, creating an avenue for ongoing studies to be performed.
In unique patient populations, such as women with breast cancer, the idea of combining ablation with an IUD is posed to allow for bleeding control and non-hormonal contraceptives. This offers patients reproductive choices beyond traditional sterilization methods, allowing for an increase in patient autonomy. Dr. Levy urges colleagues to consider the patient holistically when counseling on recommendations, due to the multifaceted long-term implications of contraceptives and gynecological procedures.
[Dr. Mark Hoffman]
What's the longest you guys have followed these patients?
[Dr. Barbara Levy]
Published data is at three years. Patients are certainly at this point six-plus years out, I think. Long enough for me to be comfortable.
[Dr. Mark Hoffman]
You mentioned Asherman's being far, far less common with cryo versus thermal ablation. Is there a place for repeat ablation for these patients with this device? I know it sounds like it's probably not been out long enough for it to be studied, but would that be a potential benefit or is there a role for that?
[Dr. Barbara Levy]
Yes. I think there are two really, really cool studies to do. One is a repeat ablation. You'd want to do an IRB-approved, inform your patients that this is not standard of care. I see no reason why you couldn't do it because you have cavity access to the whole cavity. It should be doable. Then the second one is, to Amy's earlier point, what about doing the ablation and then putting a levonorgestrel IUD in, not to prevent Asherman's, but for contraception, or a non-levonorgestrel? What if you put in a non-hormonal IUD in patients that are not good candidates?
Breast cancer patients are really good candidates. Breast cancer patients who have heavy menstrual bleeding either during their treatment or post-treatment. Young people sometimes get their periods back and we can't use hormones to manage their bleeding. Other cancers, people with leukemias and who are under treatment and have very heavy bleeding, ablation is a great technology for them.
[Dr. Mark Hoffman]
Patients who want control over their reproductive future and aren't good surgical candidates for salpingectomy or sterilization to be able to provide them with long-term contraception when they may not be able to get salpingectomy or a tubal sterilization and their partners.
[Dr. Barbara Levy]
Just to be clear though the ablation is not contraceptive.
[Dr. Mark Hoffman]
No, that's my point, it's not contraception. In patients who don't or aren't able to get permanent sterilization, being able to potentially, again an important study to think about in the future, is to be able to potentially do an intrauterine device.
[Dr. Barbara Levy]
I would love to do that study.
[Dr. Mark Hoffman]
That'd be interesting.
[Dr. Barbara Levy]
I would love to do that study. I think that saying to a patient especially these days where we don't have hysteroscopic sterilization available anymore, saying to a patient, "Well you need some permanent kind of contraception," especially if she's not partnered at the moment, that's another counseling thing.
[Dr. Mark Hoffman]
Their partner can get a vasectomy. What if they've got more than one partner? We make a lot of assumptions when talking to our patients but-
[Dr. Barbara Levy]
We do.
[Dr. Mark Hoffman]
I think having our patients-- providing them the opportunity to have reproductive choice and control over their reproductive features to make whatever decision they want without relying on a partner. That's a big part of it I think for many of our patients.
[Dr. Barbara Levy]
For now, to say that you need to have a surgical procedure for sterilization is a hard thing to say to people unless they're having a procedure anyway for some other reason. I think endometrial ablation has a place, I think it has a place in the right patient population. I also think a lot of our patients do not complain about heavy bleeding because they've had it their whole lives and they're not aware. There's no benchmark for it.
Mark Monroe and a whole group of people published a paper fairly recently about the incidents of iron deficiency in the reproductive-aged women. It's dramatic, it's really high. Women tolerate an awful lot without much complaint, and it does majorly interfere with quality of life. There's a very large group of patients who are told their only option is hysterectomy and that makes me really really sad.
[Dr. Mark Hoffman]
Most of us in the MIGS world have those patients who come to see us for that second opinion and we get to offer them a bunch of things that no one's ever told them. It's frustrating and it's sad, but also it's nice to be able to be the one to offer them those solutions. That's part of what we do, is to try to be experts in all the different approaches so we can offer whatever each patient needs in that moment or whatever they want in that moment.
[Dr. Barbara Levy]
The unintended consequences, I'm not sure we're generally aware. I'll tell you the story of a patient of mine in my telemedicine practice, who had heavy menstrual bleeding since adolescence, went to see a doctor who said, "Your only choice is hysterectomy." She never went back. She never sought care because she didn't trust anybody. Fast forward about 10 years and we saw her after her trip to the emergency room with loss of consciousness with her period, her hemoglobin was four. That's just a travesty, that should never have happened, but we don't realize that patients in their heads say over and over and over again what we tell them and then we lose their trust. Being really careful to tell a patient about all options I think is a really important message to all of our colleagues.
[Dr. Amy Park]
It is interesting about like if you only have one tool in your toolbox that's what you end up recommending, and it's such a lesson listening to you guys to just remember that it's just really important to have a lot of tools in your toolkit, in your armamentarium because patients have choices and this is ultimately a quality-of-life issue. Yes, you can get deathly ill from of course this severe anemia but people have some legitimate fears and concerns. Just parallel to the Mesh story for slings now that we have other options, patients are really, in terms of the Bulkamid urethral bulking, people really are going for that a lot more. It's important to respect the patient's autonomy and not push an agenda or a procedure, patients can sense it out right away.
[Dr. Barbara Levy]
They can. To your point, you bring up another really good point and that is for us as physicians, we need to be thinking about the long-term consequences of things that we do. Mesh is another great example of what could happen to my patient down the line with this. Again for me personally the inability to access the cavity five years from now in a patient with an abnormal bleeding episode, that worries me and it bothers me. When there's an option to do a technology that's equally effective but preserves the cavity, that would be my choice for that reason. Not the immediate differences, because immediately there's not that big a difference in their outcomes, but what's it going to be for my patient five years from now or 10 years from now?
Podcast Contributors
Dr. Barbara Levy
Dr. Barbara Levy is a professor at George Washington University and a volunteer at the University of California San Diego OBGYN and reproductive sciences department.
Dr. Amy Park
Dr. Amy Park is the Section Head of Female Pelvic Medicine & Reconstructive Surgery at the Cleveland Clinic, and a co-host of the BackTable OBGYN Podcast.
Dr. Mark Hoffman
Dr. Mark Hoffman is a minimally invasive gynecologic surgeon at the University of Kentucky.
Cite This Podcast
BackTable, LLC (Producer). (2023, October 26). Ep. 37 – In-Depth: Endometrial Ablation [Audio podcast]. Retrieved from https://www.backtable.com
Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.
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