Outpatient Procedure for the Treatment and
Relief of Symptomatic Uterine Myomas
Scott G. Chudnoff, MD, MS, Jay M. Berman, MD, David J. Levine,
Richard S. Guido, MD, and Erika Banks, MD
OBJECTIVE: To estimate the safety and efficacy of
laparoscopic ultrasound-guided radiofrequency volu-
metric thermal ablation of uterine myomas in symptom-
atic women.
METHODS: A cohort of 135 premenopausal symptom-
atic women with uterine myomas, uteri 14 weeks of
gestation-sized or less with no single myoma exceeding
7 cm, and objectively confirmed heavy menstrual bleed-
ing participated in this prospective, international trial
of outpatient laparoscopic ultrasound-guided radiofre-
quency volumetric thermal ablation. Bleeding outcomes
were measured by alkaline hematin analysis at baseline
and again at 3, 6, and 12 months posttreatment. Validated
From the Department of Obstetrics & Gynecology and Women’s Health, Mon-
tefiore Medical Center, Einstein and Moses Divisions, Albert Einstein College of
Medicine, New York, New York; the Department of Obstetrics and Gynecology,
Division of Gynecology, Wayne State University School of Medicine, Detroit,
Michigan; St John’s Mercy Hospital, St. Louis, Missouri; Women’s Health
Research, Phoenix, Arizona; and the University of Pittsburgh Medical School,
Magee-Women’s Hospital, Pittsburgh, Pennsylvania.
Supported by Halt Medical, Brentwood, California. Drs. Chudnoff, Berman, Lev-
ine, Harris, Guido, and Banks are investigators in the ongoing study: Laparoscopic
Radiofrequency Ablation of Symptomatic Uterine Myomas, which is sponsored by
Halt Medical. The authors received only materials and administrative support from
the sponsor to conduct the study. For a list of other members of the Halt Study
Group, see the Appendix online at http://links.lww.com/AOG/A366.
The authors thank Fredrick S. Whaley, PhD, of Innovative Analytics for statistical
analysis and Mimi Wainwright for research and editorial support. Halt Medical
paid Innovative Analytics and Wainwright Medical Communications for their work.
Presented at the American Association of Gynecologic Laparoscopists 41st Global
Congress of Minimally Invasive Gynecology, November 5-9, 2012, Las Vegas, Nevada.
Corresponding author: Scott G. Chudnoff, MD, MS, Centennial Women’s Cen-
ter, Montefiore Medical Center, 3332 Rochambeau Avenue, New York, NY
10467; e-mail: schudnof@montefiore.org.
Financial Disclosure
All authors’ institutions received clinical research support from Halt Medical.
Dr. Berman is on the speaker’s bureau for Merck and is a consultant for Halt
Medical, receives clinical research support from, and is on the Scientific Advisory
Board and speaker’s bureau for Boston Scientific. Dr. Levine receives clinical
research support from Idoman, Ltd. Dr. Guido receives clinical research support
from Dysplasia Research and is a board member of the American Society of
Colposcopy and Cervical Pathology.
© 2013 by The American College of Obstetricians and Gynecologists. Published
by Lippincott Williams & Wilkins.
ISSN: 0029-7844/13
VOL. 121, NO. 5, MAY 2013
MD, Micah Harris, MD,
quality-of-life and patient satisfaction scales and objec-
tive measurements of uterine and myoma volume were
conducted at 3, 6, and 12 months.
RESULTS: The mean baseline menstrual blood loss of
women in the full analysis set (n5127) was 272.7682.3 mL.
At 3-, 6-, and 12-month follow-ups, mean alkaline hema-
tin and associated menstrual blood loss decreased from
baseline levels by 31.8%, 40.7%, and 38.3%, respectively
(P,.001, paired t test). Symptom severity decreased from
a baseline mean transformed score of 61.1 to 26.6 at
12 months postprocedure (P,.001, paired t test). Health-
related quality of life improved from a mean transformed
score of 37.3 at baseline to 79.5 at 12 months (P,.001,
paired t test). At 12 months postprocedure, total mean
myoma volume decreased from baseline by 45.1% (mea-
sured by magnetic resonance imaging). There was one
serious adverse event (one of 135 [0.7%]) requiring read-
mission 5 weeks postprocedure and one surgical reinter-
vention for persistent bleeding. Ninety-four percent of the
women reported satisfaction with the treatment.
CONCLUSION: Radiofrequency volumetric thermal
ablation of myomas is well tolerated and results in rapid
recovery, high patient satisfaction, improved quality of
life, and effective symptom relief.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.
clinicaltrials.gov, NCT00874029.
(Obstet Gynecol 2013;121:1075–82)
DOI: 10.1097/AOG.0b013e31828b7962
LEVEL OF EVIDENCE: II
I n reproductive-aged women with myomas, patients
commonly present with heavy menstrual bleeding,
pelvic pain or pressure, dyspareunia, and urinary
symptoms. In 2002, Lee1 first reported the novel use
of radiofrequency ablation under laparoscopic and
intraabdominal ultrasound guidance to treat patients
with symptomatic myomas. Since then, several au-
thors have reported series of both percutaneous and
laparoscopic-guided radiofrequency ablation to treat
symptomatic myomas.2–6 Difficulties encountered
OBSTETRICS & GYNECOLOGY 1075
with available radiofrequency ablation devices in the
ablation of myomas (principally, limited uterine
myoma detection and penetration) prompted the
development of the study device (Acessa) specifically
for the treatment of symptomatic uterine myomas.
The purpose of this U.S. Food and Drug Admin-
istration (FDA)–approved study was to estimate the
efficacy and safety of laparoscopic ultrasound-guided
radiofrequency volumetric thermal ablation of uterine
myomas using the study device in women with heavy
menstrual bleeding. Study objectives were to compare
the baseline with 12-month posttreatment measures of
myoma symptom severity and quality-of-life scores
(Uterine Fibroid Symptom and Quality-of-Life Ques-
tionnaire),7 uterine and myoma volume, general
health outcome assessments (EuroQOL-5D Health
State Index8 and Overall Treatment Evaluation sur-
vey9), and menstrual blood loss as measured by alka-
line hematin analysis of women’s catamenial products
(pads, liners, and tampons). In addition, the incidence
of device-related adverse events and surgical reinter-
vention for heavy menstrual bleeding was analyzed.
MATERIALS AND METHODS
This study was designed as a prospective, multicenter,
interventional clinical trial with primary outcome
measures of change from baseline to 12 months and
ongoing qualitative follow-up of women for 3 years
posttreatment. Recruitment began in February 2009
with enrollment of the last patient in February 2011.
All women signed informed consent and were
enrolled at nine clinical sites throughout the U.S.
and two clinical sites in Latin America.
All sites were required to obtain local institutional
review board or independent ethics committee
approval of the protocol. In addition, the FDA, the
Guatemalan Ministry of Health, and the Mexican
Health Ministry granted approval to conduct this
study. The study (ClinicalTrials.gov Identifier:
NCT00874029) was, and continues to be, conducted
in accordance with general ethical principles enunci-
ated in the Declaration of Helsinki and in confor-
mance with applicable guidelines for Good Clinical
Practices, the U.S. Code of Federal Regulations for
conducting clinical studies, International Organiza-
tion for Standardization 14155, and other applicable
local or international regulations related to the rights
and welfare of human subjects who participate in
medical research, whichever provided the greater pro-
tection of the participants.
Potential women, who were self-referred or sent
directly by their health care providers, were identified
through a phone or in-person screening process in
1076 Chudnoff et al Laparoscopic Radiofrequency Ablation for Myomas
which information related to their age, medical his-
tory, menstrual status, and primary myoma-related
complaints was recorded. Study eligibility required
the following: premenopausal women, 25 years of age
or older; presence of symptomatic uterine myomas,
uterine size of 14 weeks of gestation or less by pelvic
examination, and six or fewer treatable myomas with
no single myoma exceeding 7 cm in any diameter as
measured by transvaginal ultrasound; total myoma
volume of 300 cm3 or less; cyclic menstrual blood loss
of 160 mL or more to 500 mL or less as measured by
the alkaline hematin method; a minimum of a 3-month
history of menorrhagia (menstrual blood loss more
than 80 mL) within the last 6 months; the desire for
uterine preservation but not for future childbearing;
normal coagulation profile and normal Pap test result
in the last year; and hemoglobin level of 10.0 g/dL or
more at the time of treatment. Women were excluded
for the following: radiologic evidence by magnetic
resonance imaging of adenomyosis (n5127), pedun-
culated subserosal or intracavitary myomas (n543), a
history of pelvic malignancy, cervical dysplasia, a
prior procedure to treat or remove myomas (n522),
and contraindications to anesthesia or abdominal sur-
gery (n512).
Validated questionnaires (the Uterine Fibroid
Symptom and Quality-of-Life Questionnaire and the
EuroQol-5D) were administered at baseline and at 3, 6,
and 12 months posttreatment. The Overall Treatment
Evaluation questionnaire was also administered at 3, 6,
and 12 months posttreatment. In addition, all women
had baseline and follow-up myoma and uterine size
assessments at 3-month intervals by ultrasound and
3- and 12-month contrast-enhanced magnetic resonance
imaging. Collection of women’s catamenial products for
alkaline hematin analysis occurred at baseline, 3, 6, and
12 months posttreatment.
The study device system is comprised of a dual-
function radiofrequency generator, a disposable ra-
diofrequency 3.4-mm diameter handpiece with a
deployable seven-needle electrode array and two
control buttons for inputting data and modifying
generator parameters, two dispersive electrode pads,
extension cables, and a foot pedal.10 Each needle
electrode of the array contains a thermocouple allow-
ing continuous, real-time temperature feedback. Two
side-by-side video monitors displayed the laparo-
scopic and ultrasonographic images.
All procedures were performed in a standardized
fashion using a 5-mm or 10-mm laparoscope placed
through a 5-mm or 10-mm umbilical trocar. Using
a laparoscopic ultrasound transducer (Aloka) placed
through a standard 10-mm or 12-mm suprapubic
OBSTETRICS & GYNECOLOGY
trocar, systematic ultrasonographic mapping of the
uterus identified the location, size, and number of all
myomas. The handpiece was inserted percutaneously
(directly through the skin without a trocar) under
laparoscopic visualization and was introduced into
each myoma using ultrasonographic guidance. Based
on the dimensions of the target myoma, the surgeon
selected the proper deployment of the needle array,
time of treatment, and generator settings as indicated
by a treatment algorithm. With each deployment,
ultrasonographic imaging verified that the electrode
array was entirely within the capsule and at
a minimum distance of 1 cm from the myoma capsule
(Fig. 1A–B) in all three planes, ensuring preservation
of the surrounding myometrium (Video 1 available
online at http://links.lww.com/AOG/A367). For
myomas measuring less than 1.5 cm in diameter,
deployment of the needle array was not required.
The surgeons were proficient at basic gynecologic
ultrasonography but had no advanced training. They
received brief preoperative simulation training in in-
traoperative ultrasound from the sponsor. Surgeons
learned the elements of laparoscopic ultrasound and
radiofrequency volumetric thermal ablation before
initial surgeries and generally felt proficient in two
to three procedures. No sonographers or radiologists
were needed or used at any of the procedures.
Radiofrequency volumetric thermal ablation of
myomas was carried out using a continuous, alternating
current at 460 kHz with a maximum output of 200 W.
After a 35- to 45-second ramp-up period, the tissue
Fig. 1. A. Radiofrequency ablation handpiece tip with
deployed seven-needle array. B. Ultrasonographic image of
deployed array within myoma: myoma capsule (A), tip of
handpiece (B), and one of seven electrode needle tips (C).
Chudnoff. Laparoscopic Radiofrequency Ablation for Myomas.
Obstet Gynecol 2013.
VOL. 121, NO. 5, MAY 2013 Chudnoff et al
Video 1. Overview of laparoscopic ultrasound-guided
radiofrequency volumetric thermal ablation of myomas.
Video courtesy of Holt Medical, Inc.
Chudnoff. Laparoscopic Radiofrequency Ablation for Myomas.
Obstet Gynecol 2013.
temperature reached the target of 100°C and the gen-
erator power output automatically adjusted to maintain
target temperature. Once the required time at target
temperature was completed, the surgeon terminated
the ablation, retracted the electrode array into the
probe shaft, and performed monopolar coagulation of
the probe track during probe withdrawal. Visual con-
firmation of hemostasis was performed after each abla-
tion. No suturing was required or performed. In cases
of irregularly shaped myomas, side-by-side or overlap-
ping ablations were performed at the surgeon’s discre-
tion. Often, multiple myomas were ablated through
a single serosal puncture, and most leiomyomas less
than 1 cm in greatest diameter were left untreated, as
specified in the protocol. At the conclusion of the pro-
cedure, the trocar skin and fascial sites were repaired
per standard surgical practice. After completion of the
procedure and standard postoperative care, women
were discharged on the day of treatment with instruc-
tions to return to work and normal activities as they felt
able and to refrain from sexual activity (pelvic rest) for
4–6 weeks. Ibuprofen, naproxen, or celecoxib was pre-
scribed for pain as needed.
Two potential sources of bias were the collection
of alkaline hematin by the women and the qualitative
questions posed to the patients. The former was
minimized by the evaluation of the catamenial prod-
ucts by a central laboratory that had no pecuniary
interest in the study and the latter was minimized
Scan this image to view Video 1 on
your smartphone.
Laparoscopic Radiofrequency Ablation for Myomas 1077
through the administration of standardized question- and one women was excluded after she was diagnosed
naires by study coordinators rather than investigators. with Hashimoto’s disease, which could have affected
The coprimary efficacy end points of the study her menstrual bleeding volume. Demographics of
were volume of menstrual bleeding and surgical study women (n5127) are provided in Table 1. Intra-
reintervention at 12 months posttreatment. A sample operative findings, outpatient status, and surgical rein-
size calculation was based on the null hypothesis of an tervention over the first 12-month cycle of the study
aggressive clinical efficacy assumption of a 50% or are presented in Table 2.
greater menstrual blood loss reduction based on The objectively measured effects of laparoscopic
alkaline hematin levels in at least 45% of the partic- ultrasound-guided radiofrequency volumetric thermal
ipant population (as mandated by the FDA). Setting ablation were seen by 3 months posttreatment fol-
the a level equal to 0.05, we determined that a sample lowed by continued improvement to 12 months. The
size of 135 would yield a power of 94% given the majority of women (81.9% [104 of 127]) showed
alternative hypothesis of 50% blood loss reduction a decrease in menstrual blood loss from baseline to
in 60% of the study population. Assuming a surgical 12 months posttreatment. Of the 127 women, 40.2%
reintervention rate of no more than 25% as the null (95% confidence interval [CI] 31.6–48.7%) experi-
hypothesis and setting the a level equal to 0.05, a sam- enced at least a 50% reduction from baseline to 12
ple of 87 women would yield a power of 90% under months posttreatment in their menstrual blood flow;
the alternative hypothesis of a surgical reintervention
rate of 11.5%. Based on these assumptions, we
planned to enroll at least 135 and up to 150 women Table 1. Demographic Characteristics at Baseline
in the study. Missing data that were the result of either
U.S. Non-U.S.
missed visits or loss to follow-up were not imputed. Sites Sites
All analyses were performed using SAS 9.2. Variable (n581) (n546) P*
Continuous variables for these analyses were summa-
rized using descriptive statistics (mean, standard Age (y) .005
Mean6SD 43.264.0 40.964.9
deviation, median, minimum, and maximum) and Median 43 41
categorical variables were summarized by frequencies Range 34–52 31–50
and percentages. P values ,.05 were considered sig- Race ,.001
nificant. For continuous data, P values were based on White or Caucasian 35 (43.2) 24 (52.1)
the t test, paired t test, and signed-rank test and were Black or African 43 (53.1) 0 (0)
American
not adjusted for multiple comparisons. Categorical Asian 2 (2.5) 0 (0)
variables were analyzed using the x2 test. Treatment- Other† 1 (1.2) 22 (47.8)
emergent adverse events were recorded starting with Ethnicity ,.001
the induction of anesthesia and coded using Med- Hispanic or Latina 11 (134.6) 46 (100)
DRA. Frequencies and percentages of the number of Not Hispanic or 70 (86.4) 0 (0)
Latina
women reporting at least one treatment-emergent Smoking history .071
device-related adverse event were summarized. In Current 15 (18.5) 11 (23.9)
terms of safety, the study would be successful if the Past 18 (22.2) 3 (6.5)
device-related adverse event rate was 10% or less, Never 48 (59.3) 32 (69.6)
a rate considered acceptable by the investigators and Height (cm) ,.001
Mean6SD 164.467.9 159.467.4
the scientific advisors to the sponsor. Median 165.1 160.0
Range 137.2–180.3 145.0–180.0
RESULTS Weight (kg) .011
A total of 135 women met all inclusion criteria, were Mean6SD 84.0620.0 75.0616.8
enrolled, and underwent the ablation procedure. Median 81.6 70.8
Range 50–147.4 52.0–122.5
There were no cases of intraoperative exclusion; BMI (kg/m2) .204
leiomyomas ranging from 0.7 to 9.7 cm in the largest Mean6SD 30.966.3 29.565.9
diameter were treated, and insertion of the device in Median 29.8 28.1
firm, calcified myomas was not problematic. Of the Range 19.8–47.3 19.8–45.5
enrolled women, four were excluded from final SD, standard deviation; BMI, body mass index.
analysis because they were unable to provide catame- Data are n (%) unless otherwise specified.
* Comparison of U.S. and non-U.S. sites. x2 for race, ethnicity, and
nial products at the 12-month follow-up visit; three smoking history; t test for age, height, weight, and BMI.
†
women were excluded because they became pregnant; Other: Hispanic, Hispanic indigenous, and Caribbean.

1078 Chudnoff et al Laparoscopic Radiofrequency Ablation for Myomas OBSTETRICS & GYNECOLOGY
Table 2. Intraoperative Findings, Outpatient 24.3% (95% CI 230.0% to 218.7%; P,.001) at 12
Status, and Surgical Reintervention Rate months (n5122). The mean myoma volume at base-
(n5127) line (n5124) was 80.4684.4 cm3. At 3 months (n5114),
total mean myoma volume decreased from baseline by
Myomas Imaged by Laparoscopic Ultrasonography 39.8% (95% CI 244.1% to 235.6%; P,.001) to
Total treated 640
No./woman 5.064.4 50.2657.0 cm3. At 12 months (n5113), total mean
4 (1–29) myoma volume decreased by 45.1% (95% CI 251.6%
Location* to 238.6%; P,.001) to 44.9653.5 cm3. Total uterine
Fundal 141 (22.2) volume was also measured by preoperative and post-
Miduterus 41 (6.4) operative ultrasound. Mean decreases in total uterine
Lower uterine 112 (17.66)
Anterior 224 (35.2) volume from baseline (n5126) to 3, 6, and 12 months
Posterior 219 (34.4) were observed: by 14.9% (95% CI 219.5% to 210.4%;
Left 135 (21.2) P,.001) at 3 months (n5121), 20.6% (95% CI 226.1%
Right 148 (23.3) to 215.0%; P,.001) at 6 months (n5122), and 24.7%
Broad ligament 2 (0.3) (95% CI 230.4% to 219.0%; P,.001) at 12 months
Missing 4
Type* (n5122).
Subserosal 182 (29.3) Patient-reported outcomes showed improvement
Intramural 332 (53.4) at 3 months posttreatment with continued improve-
Transmural 37 (5.9) ment through 12 months of follow-up. Symptom
Submucosal 154 (24.8) severity decreased from the mean transformed baseline
Missing 18
Length of procedure (incision to skin score of 61.1618.6 to 29.1618.9 at 3 months (n5124),
closure, h) 2.161.0 a change of 232.0 (95% CI 236.1 to 227.9; P,.001)
Blood loss (mL)† for those women with 3-month scores and continued
Uterine (n5106) 25.0 (0–100.0) improving to 12 months. Health-related quality of life
Total (n5116) 32.5 (5.0–150.0) improved over the mean baseline value of 37.3619.1
No. of outpatients‡
All sites 96.0 (120/125) to 75.1622.1 at 3 months (n5124), a change of 37.7
Surgical reinterventions through 12 mo§ 0.7 (1/135) (95% CI 33.5–42.9; P,.001) for those women with
Data are n, mean6standard deviation, median (range), n (%), or % 3-month scores and continued to improve over
(n/N). 12 months. Improvement in Uterine Fibroid Symptom
* A leiomyoma may be in more than one location or be of more and Quality-of-Life Questionnaire mean transformed
than one type; thus, they total more than 640.
†
Intraoperative blood loss was measured from collection after symptom severity and health-related quality-of-life
vacuum suction. scores over time is presented in Figure 2.
‡
An outpatient was a woman not requiring admission to the We observed a mean increase (improvement) in
hospital.
§
The one reintervention (n5135) was for a participant who had the women’s EuroQol-5D Health Status score from
been lost to follow-up and who, we later learned, sought treat- baseline to 3, 6, and 12 months of follow-up. Respec-
ment by uterine artery embolization. This patient was one of the tive mean EuroQol-5D scores and percent change
eight patients removed from the analysis (n5127), which had
a surgical reintervention rate of 0.0% (0/127). from baseline were: baseline (n5126), 71.1618.9; 3
months (n5122), 85.0612.6 (D 14.3, 95% CI
10.3–18.2; P,.001); 6 months (n5124), 84.8613.0 (D
48.8% (95% CI 40.1–57.5%) of women experienced at 13.7, 95% CI 10.1–17.2; P,.001); and 12 months
least a 40% reduction; 59.1% (95% CI 50.5–67.6%) (n5123), 85.8614.1 (D 15.0, 95% CI 11.4–18.6,
experienced at least a 30% reduction; and 67.7% P,.001). The results of the Overall Treatment Evalu-
(95% CI 59.6–75.8%) experienced at least a 22% ation surveys at 12 months (n5124) were as follows:
reduction. Collection and changes in menstrual blood when asked, “Overall, how satisfied were you with
loss are presented in Table 3. your uterine fibroid treatment?” 12.1% of the respond-
The reduction in total uterine and myoma vol- ents were somewhat satisfied, 21.0% were moderately
umes over time for each participant as determined by satisfied, and 61.3% were very satisfied with the treat-
pretreatment and posttreatment magnetic resonance ment for a total satisfaction response of 94.4%. When
imaging was evident at the initial 3-month follow-up asked, “In your opinion, how effective was this treat-
with continued decrease in volumes during the ment in eliminating your symptoms?,” 94.4% of the
9 months of subsequent follow-up visits. Total mean women responded that the treatment had been some-
uterine volume decreased by 15.7% (95% CI; 220.4% what (14.5%), moderately (29.8%), or very effective
to 211.0%; P,.001) at 3 months (n5119) and by (50.0%) in eliminating their symptoms. Furthermore,

VOL. 121, NO. 5, MAY 2013 Chudnoff et al Laparoscopic Radiofrequency Ablation for Myomas 1079
Table 3. Participant Collection and Alkaline Hematin Bleeding Results Through 12 Mo (n5127)

Variable Baseline 3 Mo 6 Mo 12 Mo

Women 127 (100) 118 (93) 124 (98) 124 (98)

Alkaline hematin (mL) 272.7682.3 187.86140.4 161.86101.7 166.96109.0
248 (160–500) 168 (0–1,290) 140 (0–551) 154 (0–635)
Percent change in alkaline 231.8 (240.3 to 223.3) 240.7 (246.9 to 234.4) 238.3 (245.2 to 231.4)
hematin from baseline*
P† ,.001 ,.001 ,.001
Decrease in alkaline hematin –87.46131.0 –110.86106.4 –103.66113.3
from baseline (mL)
P‡ ,.001 ,.001 ,.001
Decrease in alkaline hematin –92.0 (–331 to 804) –108.5 (–383 to 174) –106.0 (–435 to 289)
from baseline (mL)
P§ ,.001 ,.001 ,.001
Data are n (%), mean6standard deviation, median (range), or % (95% confidence interval) unless otherwise specified.
* Percent change from baseline51003(mean posttreatment loss–mean baseline loss)/mean baseline loss for women with alkaline hematin
measurements at baseline and posttreatment.
†
t test, null hypothesis of 0% change.
‡
Paired t test, null hypothesis of no change.
§
Signed-rank test, null hypothesis of no change.

98% of the study women responded that they would
recommend the treatment to a friend with the same
health problem: 76.6% would definitely recommend
the treatment and 21.0% would probably recommend
the treatment. Median time to return to normal activ-
ities (excluding sexual activity, n5133) was 9 days
(range 2–60 days). Those study women who reported
that they were employed (n588) missed a median of 5
days (range 0–29 days) of work postprocedure. Treated
women used their own discretion for returning to work.
Device-related adverse events were reported in five
women (five of 135 [3.7%], 95% CI 1.2–8.4%): a post-
operative pelvic abscess in the posterior cul de sac,
which required rehospitalization 5 weeks after the pro-
cedure for antibiotic treatment and a posterior colpoto-
my for drainage; a 2-cm laceration of the sigmoid colon
serosa caused by the ultrasonographic probe, which was
treated prophylactically with sutures; postprocedural
vaginal bleeding treated with intravenous iron supple-
ment; severe lower abdominal pain treated with ibupro-
fen; and a mild superficial uterine serosal burn, which
was not treated and resolved without sequelae. One
participant was lost to follow-up at 6 months and not
monitored within the study; she pursued reintervention
by uterine artery embolization at approximately 10
months after radiofrequency volumetric thermal abla-
tion (one of 135 [0.7%], 95% CI ,0.1–4.1%). We con-
sidered this participant a treatment failure.
DISCUSSION
The study results confirmed the hypothesis that out-
patient, laparoscopic, ultrasound-guided radiofrequency

100
Symptom severity Health-related quality of life

80
Symptom scores

60
Fig. 2. Improvement in symptom
severity and health-related quality of
40 75.1 77.8 79.5 life scores (Uterine Fibroid Symptom
61.1 and Quality-of-Life Questionnaire)
over time. Lower symptom severity
20 37.3 scores and higher health-related
29.1 28.5 26.6 quality-of-life scores indicate
improvement.
0 Chudnoff. Laparoscopic Radiofrequency
Baseline 3 months 6 months 12 months Ablation for Myomas. Obstet Gynecol
(n=127) (n=124) (n=125) (n=124) 2013.

1080 Chudnoff et al Laparoscopic Radiofrequency Ablation for Myomas OBSTETRICS & GYNECOLOGY
volumetric thermal ablation of myomas was safe and
effective in reducing uterine and myoma volumes,
reducing severity of symptoms, and improving quality
of life through 12 months follow-up. The posttreatment
menstrual blood loss changes showed clinically and
statistically significant menstrual blood loss reduction in
women with heavy menstrual bleeding.
The number and variety of types of study sites—
ranging from community outpatient ambulatory surgery
centers to major urban teaching hospitals—as well as
a geographically and ethnically diverse population with
menorrhagia documented by alkaline hematin testing
provided strong external factors, which validated the
appropriateness of a heterogeneous participant profile
and minimized potential bias of any single site. The
screening process leading to enrollment was rigorous.
The evaluation of both patient-reported (Uterine
Fibroid Symptom and Quality-of-Life Questionnaire,
EuroQOL-5D, and Overall Treatment Evaluation sur-
vey) outcomes and objective data (safety data, reinter-
ventions, adverse events, uterine and leiomyoma
volumes, and menstrual bleeding by alkaline hematin)
satisfied the researchers’ need for thorough evaluation
of treatment outcomes of highly symptomatic patients.
That favorable results were obtained from 11 sites
with diverse populations and by 13 surgeons—all of
whom were new to the procedure—suggests external
validity and the potential for use by the general gyne-
cologic surgeon. Potential weaknesses of the study
were the uterine size limitation and the exclusion of
small myomas (less than 1 cm) and women with men-
strual blood loss greater than 500 mL. The effective-
ness has not been tested in women with uteri larger
than 14 weeks of gestation nor in women with men-
strual blood loss greater than 500 mL. The protocol-
specified minimum preoperative hemoglobin and
hematocrit levels of 10.0 g/dL and 30%, respectively,
required that some women be administered iron ther-
apy or blood transfusions preoperatively for anemia.
Thus, these measurements were not used as an indi-
cation of efficacy. This FDA-approved study was an
efficacy and safety trial, was designed as a single-arm
cohort, and was not randomized with a comparative
arm. Because this was a population of women who did
not desire future childbearing, this study was not de-
signed to evaluate pregnancy outcomes.
It has been recommended that the clinical man-
agement of heavy menstrual bleeding be guided by
subjective, patient-centered measures.11–13 Lukes et al
correlated the objective and subjective outcomes of
treatment with tranexamic acid (Lysteda tablets) in
patients with heavy menstrual bleeding using receiver
operator characteristic curve analysis as well as alkaline
VOL. 121, NO. 5, MAY 2013 Chudnoff et al
hematin measures.11,14 They identified the minimum
change in menstrual blood loss (objectively measured
by alkaline hematin) that would be meaningful to
women who were assessed using the Menorrhagia
Impact Questionnaire, a validated patient-reported out-
come measure. The authors concluded that a reduction
in menstrual blood loss of 36 mL per cycle, or a bleed-
ing reduction of approximately 22%, was a meaningful
improvement for the majority of women. Based on the
findings reported by Lukes, 67.7% of our population
achieved a clinically meaningful reduction in menstrual
bleeding. Furthermore, patient-reported outcomes in
the present study demonstrated 94% of the study pop-
ulation was satisfied with the treatment received.
Radiofrequency volumetric thermal ablation as
described here uses laparoscopic ultrasound. The key
feature to laparoscopic ultrasound lies in the inherent
and immediate proximity of the transducer to the
target, allowing the use of higher frequencies with
significantly increased resolution.15 In addition, the
versatility and mobility of laparoscopic ultrasound
permits direct imaging from multiple directions and
angles. The short learning curve (two to three proce-
dures) required to manipulate the transducer while
interpreting image orientation and position of the
treatment probe seems within the capabilities of the
gynecologic surgeon. Laparoscopic ultrasound has
been evaluated in combination with myomectomy
because of its high sensitivity and high resolution.16,17
The Uterine Fibroid Symptom and Quality-of-
Life questionnaire has been used extensively as
a validated measure of myoma treatment outcome,
and results from the questionnaire are considered
effective measurements of outcome even when not
evaluating menstrual blood loss by alkaline hema-
tin.18–21 None of our study women experienced symp-
toms similar to postuterine artery embolization
syndrome (usually consisting of fever, abdominal
pain, nausea, vomiting, or elevated white blood cell
count, or all of these) and no women experienced
delayed cervical passage of myomas or vascular com-
promise to other organs.
Concerns exist regarding adhesion formation,
uterine integrity, and intraoperative blood loss with
techniques that require myometrial suturing.22 Radio-
frequency volumetric thermal ablation does not involve
myometrial suturing, estimated blood loss was minimal,
and surgeons were able to treat several myomas in
a single serosal puncture. The decreased serosal and
myometrial trauma and improved hemostasis associ-
ated with radiofrequency volumetric thermal ablation
could theoretically be positive factors in minimizing the
incidence of postprocedural pelvic adhesions. Ongoing
Laparoscopic Radiofrequency Ablation for Myomas 1081
evaluation and continued study of the safety of this
device are important in two populations: those with
larger uteri and heavier menses and those with infre-
quent complications. Despite the entry criteria that
required all women to have completed childbearing,
four women in this trial have conceived with two preg-
nancies ending in full-term births of healthy neonates,
one pregnancy progressing uneventfully at 7 months,
and one pregnancy ending in miscarriage. We are fol-
lowing all pregnancies in the study women; however,
we do not have sufficient safety data to evaluate the use
of the device in women desiring future childbearing.
A search of PubMed, PLoS, Medscape, and
ClinicalTrials.gov with search terms fibroids, myomas,
radiofrequency ablation, radiofrequency ablation
fibroids, radiofrequency ablation myomas, radiofre-
quency ablation leiomyomata; English articles; from
January 1990 to November 2012 showed that this is
the largest trial conducted to date addressing radiofre-
quency volumetric thermal ablation of uterine myo-
mas. Based on the results demonstrated in our
diverse population, radiofrequency volumetric ther-
mal ablation of uterine myomas safely achieved a high
rate of patient satisfaction, a low reintervention rate,
and significant improvements in menstrual blood loss,
symptom severity, and quality of life through 12
months of follow-up. Both patients and the health care
system share the burden of symptomatic myomas;
a technology, that is safe and effective and can be
administered by gynecologists is needed. Radiofre-
quency volumetric thermal ablation meets these needs
and therefore may play a significant role in the treat-
ment of uterine myomas.
REFERENCES
1. Lee BB. Radiofrequency ablation of uterine leiomyomata:
a new minimally invasive hysterectomy alternative. Obstet
Gynecol 2002;99:9S.
2. Lee BB. Three-year follow up post radiofrequency ablation of
uterine leiomyomata. J Minim Invasive Gynecol 2005;12:S18.
3. Bergamini V, Ghezzi F, Cromi A, Bellini G, Zanconato G,
Scarperi S, et al. Laparoscopic radiofrequency thermal ablation:
a new approach to symptomatic uterine myomas. Am J Obstet
Gynecol 2005;192:768–73.
4. Recaldini C, Carrafiello G, Lagana D, Currari S, Bergamini V,
Ghezzi F, et al. Percutaneous sonographically guided radiofre-
quency ablation of medium-sized fibroids: feasibility study. Am
J Roentgenol 2007;189:1303–6.
5. Carrafiello G, Recaldini C, Fontana F, Ghezzi F, Cuffari S,
Lagana D, et al. Ultrasound-guided radiofrequency thermal
ablation of uterine fibroids: medium-term follow-up. Cardio-
vasc Intervent Radiol 2010;33:113–9.
6. Ghezzi F, Cromi A, Bergamini V, Scarperi S, Bolis P, Franchi M.
Midterm outcome of radiofrequency thermal ablation for symp-
tomatic uterine myomas. Surg Endosc 2007;21:2081–5.
1082 Chudnoff et al Laparoscopic Radiofrequency Ablation for Myomas
7. Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-
Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific
symptom and health-related quality of life questionnaire for leio-
myomata. Obstet Gynecol 2002;99:290–300.
8. U.S. Valuation of the EuroQol EQ-5D Health States. December
2005. Rockville (MD): Agency for Healthcare Research and
Quality. Available at: http://www.ahrq.gov/rice/EQ5Dproj.
htm. Retrieved March 21, 2012.
9. Jaeschke R, Singer J, Guyatt GH. Measurements of health sta-
tus: ascertaining the minimal clinically important difference.
Control Clin Trials 1989;10:407–15.
10. Garza Leal JG, Hernandez Leon I, Castillo Saenz L, Lee BB.
Laparoscopic ultrasound-guided radiofrequency volumetric
thermal ablation of symptomatic uterine leiomyomas: feasibil-
ity study using the Halt 2000 ablation system. J Minim Invasive
Gynecol 2011;18:364–71.
11. Lukes AS, Muse K, Richter HE, Moore KA, Patrick DL. Estimat-
ing a meaningful reduction in menstrual blood loss for women with
heavy menstrual bleeding. Curr Med Res Opin 2010:26:2673–8.
12. Wheeler TL, Murphy M, Rogers RG, Gala R, Washington B,
Bradley L. Clinical practice guideline for abnormal uterine
bleeding: hysterectomy versus alternative treatment. J Minim
Invasive Gynecol 2012;19:81–8.
13. Warner PE, Critchley HOD, Lumsden MA, Campbell-
Brown M, Douglas A, Murray GD. Menorrhagia I: measured
blood loss, clinical features, and outcome in women with heavy
periods: a survey with follow-up data. Am J Obstet Gynecol
2004;190:1216–23.
14. U.S. Food and Drug Administration Medical Review, Lysteda
NDA 22-430; November 2009. Available at: http://www.access
data.fda.gov/drugsatfda_docs/nda/2009/022430s000sumr.pdf.
Retrieved October 11, 2011.
15. Schirmer BD. Intra-operative and laparoscopic ultrasound.
In: Holzheimer RG, Mannick JA, editors. Surgical treatment:
evidence-based and problem-oriented. Munich (Germany):
Zuckschwerdt; 2001.
16. Lin PC, Thyer A, Soules MR. Intraoperative ultrasound during
a laparoscopic myomectomy. Fertil Steril 2004;81:1671–4.
17. Angioli R, Battista C, Terranova C, Zullo MA, Sereni MI,
Cara EV, et al. Intraoperative contact ultrasonography during open
myomectomy for uterine fibroids. Fertil Steril 2010;94:1487–90.
18. Spies JB, Bradley LD, Guido R, Maxwell GL, Levine BA,
Coyne K. Outcomes from leiomyoma therapies: comparison
with normal controls. Obstet Gynecol 2010;116:641–52.
19. Manyonda IT, Bratby M, Horst JS, Banu N, Gorti M, Belli AM.
Uterine artery embolization versus myomectomy: impact on
quality of life—results of the FUME (fibroids of the uterus:
myomectomy versus embolization) trial. Cardiovasc Intervent
Radiol 2012;35:530–6.
20. Hehenkamp WJK, Volkers NA, Birnie E, Reekers JA,
Ankum WM. Symptomatic uterine fibroids: treatment with
uterine artery embolization of hysterectomy—results for the ran-
domized clinical embolization versus hysterectomy (EMMY)
trial. Radiology 2008;246:823–32.
21. Moss JG, Cooper KG, Khaund A, Murray LS, Murray GD,
Wu O, et al. Randomised comparison of uterine artery embo-
lization (UAE) with surgical treatment in patients with symp-
tomatic uterine fibroids (REST trial): 5-year results. BJOG
2011;118:936–44.
22. Sinha R, Hegde A, Mahajan C, Dubey N, Sundaram M. Lap-
aroscopic myomectomy: do size, number, and location of the
myomas form limiting factors for laparoscopic myomectomy?
J Minim Invasive Gynecol 2008;15:292–300.
OBSTETRICS & GYNECOLOGY