A Safe and Effective Method of Controlling Abnormal Uterine

Bleeding
D.E. Townsend for the Endometrial Ablation Study Group*
Park City, Utah, U.S.A.
* The Cryoablation study Group: C. Coddington, Denver Health Medical Center, Denver, Colorado,
U.S.A.; A.J. Duleba, Yale University Medical Center, New Haven, Conneticutt, U.S.A.; M. Heppard,
Columbia Rose Medical Center, Denver, Colorado, U.S.A.; P.D. Inman, Private Practice. Los Gatos,
California, U.S.A.; B.W. Welsh and K.B Isaacson, Brigham and Women’s Hospital and Massachusetts
General Hospital, Boston, Massachusetts, U.S.A.; B. Ray Love, Women’s Wellness Center, Montgomery
Alabama, U.S.A.; D. Shoupe, University of Southern California School of Medicine, Los Angeles,
California, U.S.A.; R.M. Soderstrom, Swedish Medical Center, Seattle Washington, U.S.A.; D.E.
Townsend, Park City, Utah, U.S.A.; J.J. Williams, Scripps Clinic, La Jolla, California, U.S.A.
Summary
A prospective randomized study between cryosurgical endometrial ablation and rollerball ablation was
performed in over 200 premenopausal women. Preoperative evaluation included endometrial biopsy as well
as pelvic ultrasound. Half of the patients who had cryoablation had light sedation and paracervical block as
anesthesia. All patients who had cryoablation had pelvic ultrasound to monitor the progress of the ice-zone.
Post operative, mild cramps were noted in less that ¼ of the cryo-treated patients, Significant vaginal
dischrge did not occur in any of the cryosurgical treated patients. At 12 months after treatment 44% of the
women managed by cryosurgery had only amenorrhea or spotting.
Four sites that performed over half of the cases had an amenorrhea or spotting rate of 54%. When the first
cryosurgical session was longer that the protocol required 67% had a 90% reduction in their bleeding.
The results of this study demonstrate the ease, effectiveness and safety of cryosurgical endometrial ablation
in managing women with menomenorrhagia.
Introduction
Of the 0ver 600,000 hysterectomies performed in the United States annually, over 1/3 are performed for
abnormal uterine bleeding. It is estimated that endometrial ablation for abnormal uterine bleeding is
performed in no more that 35,000 to 40,000 cases annually in the United States. A major impediment to
endometrial ablation has been the availability of an effective, safe and easily performed technique.
Cryosurgical endometrial ablation was first reported in the late 1960s[1] and early 1970s [2]. Nitrous oxide
cryosurgical systems, used primarily for treating cervical disease [3], were found to have a 71% satisfactory
outcome in women with abnormal uterine bleeding [4]. Rutherford [5], using a liquid nitrogen system,
achieved an initial amenorrhea rate of 75.5%, which was 50.3% at 6 months.
Recently a new cryosurgical unit [Her/Option] was introduced [6]. The coolant or gas used is a propriety
blend of commonly used coolants, which are non-toxic, non-corrosive and non-inflammable. A compressor
system, which is hermetically sealed, drives the unit. The coolant is re-circulated and replenishment is not
necessary. The operation is based on the Joules-Thompson principal in which pressurized gas is expanded
through a small orifice to produce cooling
Following completion of a hysterectomy study [7] which confirmed the effectiveness of the system in
producing a significant zone of cryonecrosis, a multi-center study was undertaken to determine the
efficiency and safety of endometrial cryoablation in a large group of women who complained of severe
menomenorrahagia. The 12-month results are the focus of this paper.
Materials and Methods
Eleven sites participated in the study. Four sites performed the majority of the cases. At all sites the study
was approved by an IRB. The target enrollment was 222 premenopausal women with a documented history
of menomenorrhagia i.e. PBAC score of at least 150. All had refused or failed traditional medical therapy.
Treatment was by either cryoblation or rollerball with a 2:1 randomization.
Preoperative evaluation included pelvic ultrasound, endometrial biopsy and blood studies to confirm
premenopausal state. Women with a uterine cavity volume over 300 cc, uterine sound over 10cm.and those
that contained uterine myomas over 2 cm. were excluded from the study. All women received a single dose
of a GnRh agonist 3-4 weeks prior to treatment. Cryoablation or rollerball was performed either in a
physicican office using sedation or in an operating room employing either sedation and paracervial block or
general anesthesia. The cryoablation procedure was carried out as an initial four-minute freeze to one cornu
followed by a six-minute freeze to the opposite cornu. Pelvic ultrasound monitoring during cryoablation

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was performed to confirm the location of the cryoprobe as well as to note the advancement of the cryozone.
Study subjects were seen at two weeks, three months, six months and 12 months post treatment. Phone
interviews annually have continued the follow-up. All patients were required to compile PBAC scores
before treatment and at three, six and twelve months after treatment. Patients who failed follow-up or
provide PBAC scores at 12 months were considered treatment failures.
Results
Cryoablation only
The pre-PBAC scores for Cryo [N=174] were 150-2913; mean 576 and rollerball [N=77] was 155-2030;
mean 468. Normal menstrual blood loss is defined as a PBAC score of 75 to 100.
The post-PBAC scores for Cryo. [N=156] were 0-517; mean 48 and rollerball [N=72] was 0-460; mean 24.
At 12 months the results of cryoblation in 156 women were; amenorrhrea-28%, amenorrhea and spotting-
44%, hypomenorrhea-42%, eumenorrhea-3% and menorrhagia-12%.
The results in 91 cases that were performed in the top four sites was; amenorrhea-35%, amenorrhea and
spotting-53%, hypomenorrhea-41%, eumenorrhea-0 and menorrhagia-7%.
In 12 patients the first freeze was 6 minutes followed by a 6 minute second freeze, results; 90%or greater
reduction in menstrual flow-67%, 80% reduction-92% and 70% reduction 100%. There were no failures in
this group.
Anesthesia employed: conscious sedation with or without paracervical block: 54%, andgeneral anesthesia:
46%
Side effects
There were no significant complications i.e. infection, bleeding, etc. except for one perforation that
occurred during sounding of the uterus. No patient had any significant degree of vaginal discharge. Twenty
two percent of the patients reported mild cramping during the intra-operative and immediate post-operative
period. Two percent noted nausea/vomiting following the procedure.
Of the patients who noted significant quality of life problems associated with their periods i.e. PMS,
dysmenorrhea etc. almost all had resolution of the these symptoms after successful reduction in menstrual
flow
Comment
The results of the multi-center study indicate that endometrial cryoablation is a safe, effective and easily
perfomed technique to control abnormal uterine bleeding. The lack of any significant side effects is
particularly gratifying. An unexpected finding was the lack of any significant discharge that follows
cryosurgery of the uterine cervix. This may inpart is due to the less compact myometrium as well as the
plethora of lymphatics within the myometrium, which allows the fluid after treatment to pass through the
walls of the uterus instead of out the vagina.
When compared to other commonly used techniques for endometrial ablation i.e. rollerball, endometrial
resection and thermal balloon, cryoablation has several major advantages.
When compared to rollerball or endometrial resection cryoablation is vastly easier to learn and is much
safer. There is no irrigating fluid required; therefore the chance of hyponatremia is eliminated [8]. A
mixture of common gases is the cryogen avoiding the potential dangers of electricity. There is virtually not
post-operative discharge. The results in the 11 sites were essentially equal to rollerball in terms of success.
When a longer first freeze was used the results of treatment were impressively much better.
Ultrasound monitoring may be criticized, but it accurately depicts the precise location of the cryoprobe and
permits the surgeon to know whether there is a perforation as well as monitor the advancing edge of the
cryozone. The 4.5mm of the cryoprobe essentially eliminates any degree cervical dilation, necessary with
rollerball or resection and even thermal balloon ablation.
The lack of any significant degree of peri or post-operative discomfort may be related to the known
analgesic properties of cold.
Of particular interest was the better results noted in women who had a 6 minute first freeze followed by a
six minute second freeze. This finding merely points out that a more intense freezing will likely result in a
higher degree of success. Additional studies along these lines are needed.
There is always concern that any modality used within the uterine cavity may cause injury to associated
organs. Ultrasound monitoring essentially eliminates this potential problem. Moreover, by monitoring the
developing cryozone it is possible to more accurately predict the depth of tissue destruction [9]. This
permits the operating surgeon to freeze even longer periods of time, particularly in women with suspected
adenomyosis.
McCausland reported the depth of destruction by rollerball ablation was around 2-4mm[10]. The same

171 Townsend
depth of destruction was found to true of Hydotherm ablation [11] as well as balloon ablation [12]. In
women with “deep” adenomyosis [6mm of glands extending into the uterine wall]], as defined by
McCausland [13], would likely be treatment failures by the preceding techniques. However, with
cryoablation the depth of destruction was noted to be between 8 and 12 mm, depths that should be more
effective in women with adenomyosis.
When compared to the thermal balloon cryoblation produced the same level of eumenorrhrea as well as a
90% reduction in bleeding but was significantly better in the group of women who noted amenorrhea or
spotting after treatment; ie 44% to 13%[12].
The Her/Option unit is more like a surgical tool, than just another method to perform endometrial ablation.
The treatment can be tailored for the cavity. Shorter freezes for smaller cavities and thinner uterine walls
i.e. menopausal women, and longer or multiple freezes for larger cavities. It can be used in women with
submucous myomas up to 2-cm [7] and in women with benign intrauterine polyps.
Cryosurgery has been used laparoscopically to treat liver metastasis from colon cancer. It may be possible
to treat intramural and subseroal myomas, laparoscopically as reported by Zriek [14].
The chance of freezing through the uterine wall is remote, Ultrasound monitoring provides precise
monitoring of the advancing cryo-edge. Moreover, the cryo-unit automatically shuts off after 10 minutes, a
duration of time insufficient to freeze through the uterine wall. About the only way to injure adjacent
organs would be to perforate the uterus and then commence treatment,
The chance of this occuring because of ultra sounding monitoring is remote.
Future studies will focus on longer duration of freezes a well as multiple freezes applications since the
double freeze technique is more lethal to tissue.
References
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