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BackTable / ENT / Article
The Evolution of Endometrial Ablation: From YAG Lasers to Cerene Cryoablation
Olivia Reid • Jan 17, 2024 • 31 hits
Through technological advancements, randomized clinical trials, and increased global accessibility, endometrial ablations have greatly decreased the reliance on hysterectomies in controlling abnormal bleeding in women. Doctors Barbara Levy, Mark Hoffman, and Amy Park walk through the history and evolution of gynecological interventions from the rudimentary days of YAG lasers and rollerball electrosurgery to the more recent use of heat and cryo technologies. With the emergence of Her Option and Cerene cryoablation, in-office procedure efficiency has greatly improved while also providing patients with a more comfortable procedural experience. Importantly, new cryoablation technologies also allow for long-term cavity access and minimized post-ablation side effects.
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
• Pioneers like Milt Golrath and Frank Loffer initiated the journey to manage abnormal bleeding without resorting to hysterectomy through early techniques involving YAG lasers and rollerball electrosurgery.
• Cryoablation, first offered by Her Option, offered a more tolerable in-office procedure but could be time-consuming, leading to the emergence of Cerene cryoablation technology, which focused on efficiency.
• Compared to heat-based therapies, cryoablation provides over 90% visualization of the cavity long-term, allowing for effective post-ablation monitoring.
Table of Contents
(1) The History of Endometrial Ablation Technologies
(2) Modern Endometrial Ablation Devices
The History of Endometrial Ablation Technologies
The history of endometrial ablation has paved the way for current gynecological interventions. Beginning with doctors Milt Golrath and Frank Loffer, two thought leaders, the field sought alternatives to hysterectomy in order to manage abnormal bleeding during menstrual cycles. This commenced with techniques involving YAG lasers and fiber, which created challenges in achieving comprehensive endometrial coverage without perforation. In later years, the introduction of electrosurgery with the rollerball marked a pivotal moment, emphasizing the necessity of skill in hysteroscopy. This technique was grandfathered into use in the 1980s, prior to the implementation of the rigorous FDA device approval process.
Furthermore, industry involvement increased and led to ThermaChoice, a balloon technology, which revolutionized previous procedures through increased patient tolerance and simplification of the procedure. Dr. Levy highlights how these historical changes led to the transition in the gynecological field of medicine from randomized clinical trials to single-arm studies, allowing for the democratization of endometrial ablation for broader use and increasing the scope of eligible patients.
[Dr. Barbara Levy]
It's another amazing evolution starting with my career. It started with the thought leaders, Milt Golrath and Frank Loffer, who were thinking about ways to manage abnormal bleeding without hysterectomy. In the days when I learned hysteroscopy, I learned how to do things using a cystoscope without continuous flow. That's how rudimentary things were at that time. The beginning of endometrial ablation was really Milt with the YAG laser and using a fiber. You can imagine how tedious that was to take a fiber and try to get the entire endometrial cavity, try not to perforate the endometrial cavity, and then electrosurgery with the rollerball. Again, we used to teach people it's like mowing your lawn, you want to overlap areas. It was really dependent on how thick the endometrium was, the settings of the electrosurgical generator, the size of the rollerball. It was all monopolar at that time. There were a lot of variables in terms of how people did. It all had to be done under anesthesia in an operating room.
Industry got involved and they said, "Well, we can think about some better ways to do this." I actually sat on the OB-GYN devices panel as the FDA was considering what sorts of studies they would require for these concepts of global endometrial ablation. The early studies were randomized clinical trials, randomizing people to rollerball or the newer technology. The first one out was the balloon, ThermaChoice, which was reasonably good, but it was still heat. There were, I will say, enthusiastic OB-GYNs who did it in the office. They had very tolerant patients. Most patients in the United States would not tolerate the heat in an office setting without analgesia of some kind. It really took off the concept that you didn't have to have this great skill set in hysteroscopy, because frankly, to get a rollerball up into the cornu to make sure that you were getting the entire cavity, to make sure that with full duration, with electrosurgical energy, you can toast the surface and not get deep. You really had to have a deep understanding of electrosurgical energy to understand how fast to move the rollerball, how to overlap, how to do it.
The results were variable. The concept of global endometrial ablation was awesome. It was a way to democratize, if you will, that all OB-GYNs would be able to do this kind of procedure. In the early days, the early studies were very limited in terms of who were the right patients. The patients had to be ovulatory. They had to have a relatively normal-sized uterus with no fibroids. Those were the initial inclusion criteria for the randomized clinical trials. Then as more and more of these devices came on market, FDA became more comfortable with doing single-arm studies and comparing retrospectively to rollerball, which was an easier study to do for people in industry. The whole concept of endometrial ablation was always to reduce heavy menstrual bleeding to normal or less. The concept of creating amenorrhea was actually never the goal. The goal was to reduce heavy menstrual bleeding to the point that we could avoid hysterectomy. That's a baseline history.
[Dr. Mark Hoffman]
How did rollerball become the standard without such rigorous testing? It seems like it was just grandfathered in or was it just people doing it?
[Dr. Barbara Levy]
Yes. In the 1980s and early 90s, things that had always been used were grandfathered, but it was also that there wasn't a specific device that had to be approved by FDA. There was an instrument. The rollerball was an instrument that went onto the hysteroscope, but it wasn't a medical device in the true definition of how FDA-- I'm sure the rollerball had a 510 K because it's the same as a ball you would use at an open procedure, a ball electrode.
[Dr. Mark Hoffman]
Is there a urologic use for rollerball or is that something that was made specifically for gynecology or do you know?
[Dr. Barbara Levy]
I don't know, but you could imagine that it probably was used for coagulation of bleeding in the bladder or at the prostate, prostate bed, if people were doing prostatectomies. I don't recall there being some, "Oh, look at this new instrument." I just recall that we had loops and we had rollerballs and that's what people used. I think the YAG was a little bit more problematic in terms of approval, except that YAG lasers were already approved. FDA was in its infancy in terms of devices. On the pharma side, the FDA has been around for a really long time, but the Devices Act actually grandfathered a lot of things on the device side.
[Dr. Mark Hoffman]
That seems like a whole other episode where we could talk about 510 Ks and FDA and all that stuff.
[Dr. Amy Park]
I haven't done hysteroscopy in a long time, but you're coming up against-- I'm just thinking back of all these innovations just in hysteroscopy. I trained in rollerball and I remember when the ThermaChoice and the balloon came out and the NovaSure with the cornu and covering the cornu because of the shape and all of these other things that actually precluded the need for worrying about a fluid deficit, bipolar energy, and using saline instead of these hyperpolarized molar fluids. I forgot about all of this stuff, but we've seen a lot of stuff in the last 20 years.
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Modern Endometrial Ablation Devices
Following the evaluation of earlier methods of controlling bleeding such as bipolar mesh devices, which led to burns and bowel injuries in many cases, cryoablation became the major technique on the market through the introduction of the Her Option system. Although time consuming, Her Option provided a significantly more comfortable procedure that could be performed by clinicians in the office. The time factor contributed to the continued use of heat technologies, including steam, microwave, and bipolar mesh, by women, despite the aforementioned drawbacks.
The invention of Cerene cryoablation technology allowed for improved patient comfort with increased efficiency of the procedure. According to long-term follow up studies, the Cerene technology allows for 90% uterine cavity visualization post-ablation, which is a substantial advantage in comparison to other modalities. Cavity access post-ablation is crucial for evaluating patients longitudinally and distinguishing cryotechnology's benefits in minimizing adhesions and scars. Further comparison of heat and cryo technologies led to the discovery that cryoablation minimizes the risk of Asherman’s syndrome and oftentimes limits abnormal vaginal discharge, fibroid-related issues, dyspareunia, and persistent bleeding.
[Dr. Barbara Levy]
We have. The MAW database, which is the database where complications are theoretically reported to FDA, and manufacturers are required to report when they know about a complication, but we as surgeons and hospitals don't have that same regulatory requirement. We know that the MAW database is not complete, but we started to see some complications related to something like bipolar mesh device that sucks on the uterine wall and then delivers deep energy. As we think about our patients who've had five C-sections and their risk of dehiscence, we can think about how thin that uterine scar might be. We started to see burns. We started to see bowel injuries. We started to see some things.
Along came cryoablation. Cryoablation always sounded really great to me because you were freezing and therefore numbing the nerves as you were doing the procedure. It was much more tolerable in the office, but it was a very kludgy system. It was called Her Option. It was that you had to create ice balls throughout the uterine cavity overlapping under ultrasound guidance. You were determining how deep, how big an ice ball to do. Then you had to thaw it. Then you had to go in another location and then you had to do it again. It took quite a long time. It was ultrasound-guided, but it did work.
What I loved about it was that patients were super comfortable. The only uncomfortable part of that procedure was the initial dilation, which was only-- I don't remember exactly how big the dilator was, but it was maybe six millimeters. It wasn't eight or nine. Cryoablation had a little bit of a following just among the people who like to do procedures in the office. Again, there were people who were doing the heat procedures in the office, but as time went on, I think our office staff and our nurses, and others complained a lot about patients-- It's really bad for business when people are screaming in the office. People in the waiting room don't like to hear that.
It became more standard for people to engage with anesthesiologists or nurse anesthetists and to do IV sedation, which added risk and added time to those procedures. It still was financially lucrative to do them in the office because all of-- Mark, this is to all of the things we talked about at CHECK--All of the overhead costs of doing those procedures is covered when you do them in the office. When you do them in a facility, whether it's an ASC or hospital outpatient, the hospital or the facility is getting all of that payment for all of those things.
[Dr. Mark Hoffman]
I don't know that I've seen an office endometrial ablation. I remember rollerball. I remember having to make sure patients didn't get pressed after their-- before we were using saline and things like that. Most of what I see now is in the OR. Talk to us about the options. What are people using now? What are the most common and what's available that people are maybe using less frequently and how do they compare?
[Dr. Barbara Levy]
There are lots of options out there. Companies have seen the 200,000 or so cases that are being done a year and recognize that that's a reasonably good market. Women will continue to have heavy menstrual bleeding. Again, reasonably good market. What we have now are a bunch of heat technologies, whether they're steam, there was microwave for a while, there's still the bipolar mesh, which is very, very popular, but really painful. It is short, but it's really, really uncomfortable. I don't know anyone in the United States who's doing that procedure without IV sedation. Now, there are many practices that are doing IV sedation in the office. To me, that means now you have to have a recovery area and you have to have an RN that's dedicated to watching that patient. You have to make sure she has a ride home. There's a lot of infrastructure and overhead that goes into trying to do that.
About 10 years ago, a company got started looking at how they could do cryoablation more effectively, efficiently, and really make it an office procedure that worked. A lot of engineering went into this current cryoablation technology, which is called Cerene. Again, I'm a big fan of cryo, both for the anesthetic aspects of it and something we didn't mention before, but the healing of the endometrial cavity post-ablation is different after freezing than it is after heat. I can't explain to you the why, but I will tell you that most of the amenorrhea associated with the heat technologies is related to the creation of Asherman's. It is that the walls of the uterus stick together. We know that the post-ablation syndrome often comes from little islands that are still active above an area of dense scarring that cyclically will create severe pain.
Access to the uterine cavity-- Again, as a doctor who practiced in the same community for 30 years, I followed my patients across the lifespan and it always bothered me that I was doing something or I might be doing something that would preclude my ability to evaluate my patient long-term. What if she had an episode of abnormal bleeding five years after the ablation? How am I going to work that out? How am I going to evaluate that? Can I see the entire cavity? Can I feel confident that if I'm sampling something that she doesn't have cancer in there?
[Dr. Mark Hoffman]
I think that's why a lot of us in the MIGS world think a little bit more about global endometrial ablation maybe than others because we see so many of the complications. I don't mean allergy-type complications, but maybe the failures more so than the complications with the patients who undergo it and they have pain afterwards, whether it's post-ablation syndrome, whether it's failure, whether it's eight years later, they're menopausal and having bleeding and I can't sample the cavity and the ultrasound doesn't tell me much of anything. The lining is--
[Dr. Barbara Levy]
Well, you try to put a hysteroscopy in there and you just--
[Dr. Mark Hoffman]
You hit a wall.
[Dr. Barbara Levy]
Yes. It's seriously Asherman's syndrome. For me, cavity access is a major distinguishing feature of cryotechnology compared to heat of any kind.
[Dr. Amy Park]
What do you see when you go back in afterwards because I've only-- after post-ablation with heat, it's stuck together, it's fried.
[Dr. Barbara Levy]
It's a mess. The long-term follow-up for Cerene specifically was over 90% ability to see the cavity long-term. For me, that's really a big plus.
[Dr. Mark Hoffman]
What does that compare to other modalities, like 90% compared to--
[Dr. Barbara Levy]
They haven't even done those studies. Cavity access is-- because that's bad news for them. Everything Amy just said is exactly what happens. You try to put a scope in there and you just see adhesions, you see scars, and it's part of the mechanism of action. They work really well when they work well for that reason.
[Dr. Amy Park]
I'm not a usual ablation person. I actually presented SGS and I published something in fellowship with Linda Bradley about post-ablation-- actually uterine artery embolization complications, but also there was along those lines during that same period in the late 2010s era with all those sequelae of abnormal vaginal discharge, prolapsing fibroids or dyspareunia, persistent bleeding, the post ablation tubal syndrome. I've seen that a couple of times.
[Dr. Barbara Levy]
It's devastating. It's really bad.
Podcast Contributors
Dr. Spencer Payne
Dr. Spencer Payne is a professor and medical director of otolaryngology head and neck surgery at University of Virginia Health and the co-founder of RefluxRaft.
Dr. Ashley Agan
Dr. Ashley Agan is a practicing ENT and assistant professor at UT Southwestern Medical Center in Dallas, TX.
Cite This Podcast
BackTable, LLC (Producer). (2024, January 30). Ep. 156 – RefluxRaft: A New Option Beyond Conventional Therapy [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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