Freezing in Endometrial Ablation

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Dr. Hugo Verhoeven: "My name is Hugo Verhoeven from Dusseldorf in Germany. I'm a member of the Editorial Advisory Board of the OBGYN.net, and it gives me great pleasure to have the chance to talk this afternoon to Dr. Martha Heppard from Denver, Colorado. She has some exciting news for us, especially for so many of the women in the United States and all over the world who are suffering from heavy menstrual bleeding or bleeding all of the time. So you have quite a lot of experience with the new technique of treating those patients and avoiding a hysterectomy. It is my understanding that in the United States, maybe more so than in other parts of the world, hysterectomy is still very well accepted and frequently performed for patients with heavy bleeding. It's not any more the case in Europe, so what is new in what you are offering your patients?"


Dr. Martha Heppard: "The United States is really trying to catch up in this area. We have such tough FDA regulations that's it's very hard to get new and improved techniques available to the American women. We do find about 2,500,000 women in the United States do have menstrual disorders each year and over half a million of these are hospitalized for them. Dysfunctional uterine bleeding is when there's more than 80 cc's of blood per menstrual cycle, and this is up to 22% of our American women, and it's very similar throughout Europe. As many as 45% of the 600,000 hysterectomies done in the United States each year are done for dysfunctional uterine bleeding."

Dr. Hugo Verhoeven: "So they have a hysterectomy?"

Dr. Martha Heppard: "Yes, that's exactly right."

Dr. Hugo Verhoeven: "Do you have any idea on the cost of this?"

Dr. Martha Heppard: "It generally ends up costing in American dollars approximately $10,000 to $11,000, and the cost is usually a two- to four-day hospital stay and six weeks for recovery for these women."

Dr. Hugo Verhoeven: "So it's a real economical problem and an economical success if somebody would find a way to reduce your costs."

Dr. Martha Heppard: "Definitely, and about a decade ago researchers and clinicians developed a method of endometrial ablation . They started off with the YAG laser which has also been used in Europe, and that took procedure several hours to perform. Subsequently, a method called "rollerball endometrial ablation" was developed . This was a very nice device but at the same time general anesthesia is required, and rest for the patient because of the amount of cervical dilation that's needed and a great deal of recovery time was associated with it."

Dr. Hugo Verhoeven: "So for our listeners - what is ablation and how do you do that?"

Dr. Martha Heppard: Ablation means destruction so what we're trying to do. First however, anyone with abnormal bleeding should be seen by their doctor. Sometimes hormonal problems can be the issue , and if so we want to correct the hormonal problem. If we can't correct it or if isn't hormonal problems, then we want to try and destroy the uterine lining as long as there's nothing else that contraindicates a conservative procedure like an endometrial ablation."

Dr. Hugo Verhoeven: "So there are many different types of endometrial ablation?"

Dr. Martha Heppard: "Yes."

Dr. Hugo Verhoeven: "You mentioned the laser and the rollerball, you also have balloon therapy, and you can inject hot water into the uterus - all methods have advantages and the disadvantages. It's my understanding that you are now freezing the mucosa of the uterus. Tell me how it works and what the advantages of this are."

Dr. Martha Heppard: "This is really very exciting, and I am so pleased to be one of the investigators for this new device, the reason is that all the other devices use heat - they're using cold. Cold is a natural anesthetic, and with cold we can use less pain medicine, and women can return to work sooner. With all methods of endometrial ablation we want to be looking at first of all - safety for the patient. And we want to be looking at costs and the ease of use for the doctors and their staff, and patient comfort. We have all of these with the freezing therapy, specifically, the first option by cryogen."

Dr. Hugo Verhoeven: "So let's start with the first important thing for the patients. What are they going to feel? How are you going to do that? They're coming to your office - tell us exactly what you are going to do to the patient?"

Dr. Martha Heppard: "We first will give them a medication which is similar to Advil or Motrin. We can give it in a shot form so it's a pretty strong dose of this but it's not a narcotic, or a drug. Then once they have it in their system for a little bit, they could take some tablets to help their pain relief like Motrin and Advil. We then will do a sterile prep of their vagina and put a speculum in to take a look at the cervix. We'll just put a numbing block in the cervix - just like what a dentist would use for a dental procedure - that's really all they need."

Dr. Hugo Verhoeven: "Then you insert a device into the uterus?"

Dr. Martha Heppard: "Yes, this device is very, very thin and the majority of women tolerate it very well."

Dr. Hugo Verhoeven: "Without dilation?"

Dr. Martha Heppard: "Yes, no dilation is really needed for this, very rarely would any dilation be needed. Once we insert this very thin instrument, we freeze the uterus for about four minutes, and then we freeze the other side for about six minutes. Then we're done with the procedure, and we'll take the instruments out."

Dr. Hugo Verhoeven: "How deep is this freezing going? What is destroyed exactly or what is frozen?"

Dr. Martha Heppard: "What is destroyed is the uterine lining. It's just like, for example, if you fall down and skin you knee on the ground, that skin or scar is a little bit tougher than the other skin on your body. What we're trying to do is just toughen up this tissue. It's called the endometrium, that's where the bleeding comes from. So if there's less endometrium then there's going to be less bleeding, and we've had great success rates at reducing that amount of bleeding."

Dr. Hugo Verhoeven: "So the first thing that we have already is the patient is happy with this treatment. What does this treatment cost the patient in comparison with other techniques?"

Dr. Martha Heppard: "It's much less expensive than the traditional methods of laser and rollerball. It's very comparable to the other simple techniques that have come out. It's very comparable to the balloon that's out there, for example, and the hot water treatments. But what's so nice is even though the cost is the same, there's less pain, and there's a very rapid return to work. Ninety-nine percent of my patients are back at work the next day."

Dr. Hugo Verhoeven: "The next day?"

Dr. Martha Heppard: "Yes."

Dr. Hugo Verhoeven: "The most important thing is - what about safety?"

Dr. Martha Heppard: "It has been approved by the FDA here in the United States and because of that we really have proven safety. Very few instruments have actually passed the FDA in the endometrial ablation area - so it is proven to be safe, it is very cost efficient, and the ease of use for me is so much easier to use than the traditional methods. It is just a very thin instrument that gently slips into the uterine cavity, and my staff doesn't need to be doing very much outside of handing me the instrument so that simplifies the procedure for the patient too. And they're very happy because they basically walk out of the room and go home."

Dr. Hugo Verhoeven: "Next question of course, are they happy also in the long run, that means what is the success rate after six months, and after one year? Does the patient have to come back or after you do the treatment is the patient happy for the rest of her life? What is the probability that the patient has to come back and have another treatment?"

Dr. Martha Heppard: "We have not had to repeat the treatment in any of our patients. We've been following them up at two weeks, three months, and then every three months until one year, and then at two years. So we find that the longer out we get, the happier the patients are. By one year out we've had 50% of our patients have absolutely no bleeding, and 10% will have just a few spots each month. So 60% of women have no or just minimal, minimal spotting, 90% of our patients at six months have returned to normal flow or less, and by twelve months 100% have a normal flow which again is much less than what they came in with - a normal flow to less. So we have had 100% success rate as defined by returning menses to normal or absence of menses."

Dr. Hugo Verhoeven: "That's very encouraging."

Dr. Martha Heppard: "It is, it's very nice."

Dr. Hugo Verhoeven: "So among our listeners there are certainly also some doctors, and we shouldn't think always about the cost for the patient. What about a doctor who wants to do this in his office? I think you can do this office based or do you have to do it in a hospital?"

Dr. Martha Heppard: "I really see this as being able to be office based, and in Europe we would probably be able to start off with office treatments. Here in the United States, the criteria are so strict that at this point we've primarily been in the outpatient area. A few of our investigators have been doing them in their offices. It is very hard to do an office procedure here the United States, but technically if I had my choice of where I could do it, I would be doing it in my office."

Dr. Hugo Verhoeven: "My final question is - what is the cost of the machine? If you want to do it in your office, you have to invest the money for the machine so what amount of money are we talking about?"

Dr. Martha Heppard: "I would really refer you to Cryo-Gen for that because…"

Dr. Hugo Verhoeven: "The Cryo-Gen Company is manufacturing this."

Dr. Martha Heppard: "They could more appropriately answer the questions about the cost because it gets very technical so I would really refer it to them. But there are leases available and all of that. I think it runs about $20,000 but that is quite a bit of money. Yet if we're able to do treatments that otherwise $10,000 would be needed for the cost of the hysterectomy - the cost of two hysterectomies right there cover the cost of the machine."

Dr. Hugo Verhoeven: "Good news for those million women world wide with heavy menstrual bleeding. Thank you very much for this very interesting interview."

Dr. Martha Heppard: "Thank you for the opportunity. I appreciate it."


Editor's Note: Dr. Martha Heppard is an investigator for CryoGen, Inc. which manufactures the Cryoablation instrument discussed in the interview.