Uso de Radiofrecuencia para Fibromas Uterinos

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GYNECOLOGY PEER-REVIEWED

Radiofrequency ablation
for uterine fibroids
Understanding the technology behind a newer uterus-sparing
option for the management of uterine fibroids.
by SHABNAM GUPTA, MD; AND JAMES ADAM GREENBERG, MD

U
ter ine fibroids (als o
known as leiomyomas or FIGURE 1 Treatment Options for Management of Uterine Fibroids
myomas) are the most
common pelvic tumors
SYMPTOMATIC UTERINE FIBROIDS
found in women and
the most common indication for Do nothing Do something
Medical options
hysterectomy.1 There is a nearly 70% (temporizing)
prevalence in premenopausal White Destroy fibroids Remove fibroids
women and over 80% prevalence in
premenopausal Black women. These Ischemic necrosis Thermal necrosis Myomectomy Hysterectomy
tumors can cause symptoms including
abnormal uterine bleeding with heavy
Uterine fibroid Uterine artery Hypothermic Hyperthermic
menses, pelvic pain (both menstrual embolization occlusion ablation ablation
and nonmenstrual), bulk symptoms
(eg, abdominal distention, bowel or Cryoablation Microwave HIFU RF
bladder dysfunction, early satiety), ablation ablation ablation
and reproductive issues (eg, recurrent
pregnancy loss, infertility).2
Bipolar Monopolar
Treatment options for fibroids can
be divided into 3 approaches: tem-
Abbreviations: HIFU, high-intensity
porizing measures to shrink fibroids, focused ultrasound; RF, radiofrequency.
Laparoscopic Transcervical
RF ablation RF ablation
destruction of in situ fibroid tissue, or Source: Author supplied.

JAMES ADAM GREENBERG, MD, is associate SHABNAM GUPTA, MD, is a minimally invasive
professor of obstetrics and gynecology at Harvard gynecologic surgery fellow at Brigham & Women’s
Medical School and chief of gynecology at Brigham & Hospital and degree candidate at the Harvard T.H.
Women’s Faulkner Hospital in Boston, Massachusetts. Chan School of Public Health. 

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removal of fibroids (Figure 1). Temporiz- of a laparoscopic ultrasound-guided


ing measures often employ hormonal FIGURE 2 approach to treat fibroids using RF
medications that exert influence on the Timeline of Radiofrequency energy, known as the Acessa procedure
hypothalamic-pituitary-gonadal axis. Use in Surgery (Hologic). This device received FDA
The gonadotropin-releasing hormone approval in 2012. In parallel, another
(GnRH)-agonist analogue (leuprolide) 1928 Bovie introduces technology focused on a transcervical
and GnRH-antagonist (elagolix and electrosurgery with RF approach to RF fibroid ablation began its
relugolix) work by decreasing pituitary development in 2005. That technology,
secretion of luteinizing hormone and 1993 McGahan uses RF Sonata (Gynesonics), a RFA device using
follicle-stimulating hormone, resulting to ablate liver tumors an incisionless transcervical approach to
in reduced ovarian follicular activity, ablate fibroids, was cleared by the FDA
anovulation, and low serum concentra- in 2018 (Figure 2).
2002 Lee uses RF
tion of estradiol and progesterone. While to ablate fibroids
fibroid size decreases in response to How does RFA work?
decreased estrogen and progesterone, RF waves have the longest wavelength,
2012 FDA approves
these medications can have adverse Acessa L-RFA lowest frequency, and lowest energy
effects, including hot flashes and reduced on the electromagnetic spectrum (RF
bone mineral density, which limit their range, 3 kHz-300 GHz; medical RF
long-term use. Additionally, these 2018 FDA approves Sonata T-RFA range, 450 kHz-500 kHz). These char-
medications have a very limited effect on acteristics make application of RF waves
reducing fibroid size, which is not helpful Abbreviations: L-RFA, laparoscopic an ideal candidate for controlled and
radiofrequency ablation; RF, radiofrequency;
for women affected by bulk symptoms. T-RFA, transcervical radiofrequency ablation. predictable ablation of human tissue.
Women who do not desire or do A generator creates alternating current
not respond to medical management, management of uterine fibroids, with an that is transmitted to target tissue via
or those who have contraindications emphasis on understanding the basic exposed electrode (Figure 3). Current
to these options, may elect surgical principles underlying this technology. travels back to electrode return pads
treatment. While hysterectomy is the (grounding) to complete the circuit.
only definitive surgical treatment, History of electrosurgery In electrosurgery, typically there is a
uterus-sparing procedures are often Electrosurgery first came about in the cathode or point where electrical cur-
sought due to their less invasive and 1920s. William Bovie, PhD, was an rent leaves a polarized electrical device.
fertility-sparing nature. Surgical man- American inventor and scientist. He This is known as the active electrode,
agement of fibroids can be divided into completed his PhD in plant physiology and the RFA probe tip functions as the
resective and nonresective procedures. at Harvard University in 1914. He was cathode in the system. The electrical
Myomectomy is a procedure in which credited with conceptualizing biophysics current transfers energy to surrounding
fibroids are resected from the uterus and inventing a crude monopolar RF structures through a process termed
via transabdominal, laparoscopic, or electrode in 1928 (now widely used in energy flux. A small cross-sectional area
hysteroscopic approaches. surgery and called the Bovie). In the of the probe tip leads to high energy flux at
Techniques to reduce the size of 1990s, RF energy was first suggested the area in closest proximity to the active
fibroid tissue without overt resection to ablate liver tumors. Since then, RFA electrode. Monopolar electrical systems
include uterine fibroid embolization, has been applied to treat cancers in the require return dispersive electrodes,
focused ultrasound (FUS), which can be adrenal gland, breast, kidney, bone, lung, which are typically used in the form of
performed under magnetic resonance pancreas, and thyroid, and it is also used pads placed transversely on the patient’s
guidance (MRgFUS) or ultrasound guid- for nerve ablation in the treatment of anterior thighs, in order to close the elec-
ance (USgHIFU), and radiofrequency pain syndromes. Bruce Lee, MD, was first trical circuit. The large cross-sectional
(RF) ablation (RFA). Here, we will focus reported to use RFA on uterine fibroids area of the dispersive electrodes leads
on nonresective RFA technology for in 2002. He spearheaded the creation to a very small energy flux and therefore

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T-RFA), and both technologies assume


FIGURE 3 The RFA Circuit maximal tissue damage when calculat-
ing the ablation times. One limitation
of RFA is its need for good electrical and
thermal conductivity to achieve tissue
injury. In vivo, maximal ablations are
challenging due to “heat sinks” and insu-
lators. The electromagnetic waves that
are needed to ablate tissue propagate
only through viable cells. Heat sinks,
Generator Monopolar RF such as blood vessels that reduce simple
device
thermal conduction and/or charring
of tissue that insulates against simple
Dispersive
electrodes thermal conduction, can reduce tissue
temperature and thus yield submaximal
ablations. An appreciation for these prin-
Abbreviations: RFA, radiofrequency ablation; RF, radiofrequency. ciples has enabled engineers to develop
Source: Author supplied.
devices with predictable ablation zones
to maximize the target tissue ablation
serves as a safe way to disperse the energy increases. Further, temperature rise and minimize surrounding tissue
return in the circuit. It is important to has predictable cellular effects. At damage when applying this technology
ensure proper placement of dispersive temperatures greater than 60 °C, cell to patients.3
electrodes because any break of the death occurs. Between 60 °C and 99 °C,
closed circuit can cause electrical shorts tissue desiccation and protein coagula- ARRANGEMENT OF
that result in patient burns. tion occurs. At temperatures greater ELECTRODES
than 100 °C, vaporization and char- By understanding electromagnetic
Factors influencing size ring may occur. Both the temperature and thermal conductivity principles
and shape of ablation reached and the duration of exposure of tissue ablation, one can quickly
A few essential concepts should be are important. Human tissue is very see that a single electrode will yield a
considered when thinking about the use sensitive to temperature changes and cylindrical ablation zone rather than
of RF waves to ablate tissue. Factors that the time to reach cell death differs the spherical injury that is desired. To
influence the size and shape of the abla- depending on the temperature. For overcome this limitation, engineers
tion zone include tissue temperature, example, at 55 °C, tissue death occurs have developed several different
tissue conductivity, and arrangement within 2 seconds. At 100 °C, cell death electrode designs (plain, cooled, wet,
of electrodes. is effectively instantaneous. This is not a expandable, and bipolar) with varying
desired outcome in application of RFA, combinations employed to achieve the
TISSUE TEMPERATURE as charred tissue insulates and prevents desired application.4 The details and
The RF probe itself is not the source of transmission of heat. Instead, a slow, advantages of these features go beyond
heat. It generates an alternating elec- methodical deposition of energy is more the scope of this review, but both Acessa
tromagnetic field that causes adjacent effective in ablating target tissue rather and Sonata employ plain, expandable,
molecules (composed of mostly water) than a rapid and high temperature rise.3 multitined electrodes.
to vibrate. These particles in motion
generate heat, which is transmitted TISSUE CONDUCTIVITY L-RFA and T-RFA
farther by tissue conductivity. The Safely calculating the size of the targeted- Both L-RFA and T-RFA are safe and
temperature drops exponentially as tissue ablation is crucial to both laparo- effective procedures once surgeons
distance from the source electrode scopic and transcervical RFA (L-RFA, have been appropriately trained on

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their use. While both technologies


utilize ultrasound guidance to direct FIGURE 4 The Acessa Procedure Diagram
placement of monopolar, expandable,
multitined RF electrodes into myomas,
they do differ in how they achieve this.

Laparoscopic RFA
(Acessa procedure)
The Acessa ProVu System enables
percutaneous, laparoscopic sonogra-
phy-guided RFA of uterine fibroids. A
standard 5-mm laparoscope is used in
combination with a 10-mm reusable
laparoscopic ultrasound probe and
a separate disposable RF handpiece,
which enters the abdomen through a
small adjacent percutaneous incision.
The ultrasound probe is placed directly
on the uterine serosa to identify the
location and size of the fibroids. Next,
using the Acessa Guidance System,
electromagnetic spatial tracking is
employed to orient and position the
handpiece. The handpiece is advanced (Used with permission: Yu et al. JSLS. 2020)
to the fibroid and carefully inserted
1 cm into the fibroid capsule. The elec-
trode array is deployed into the fibroid FIGURE 5 The Acessa Procedure
and appropriate placement confirmed.
The ablation process is initiated by
depressing a foot pedal. The RF genera-
tor then begins to heat the tissue. Once
the tissue target temperature (95 °C) is
reached, the ablation time begins. After
the ablation duration is complete, the
foot pedal is again depressed to stop
the procedure. The electrode arrays are
then retracted, and the handpiece tip
is allowed to cool for 60 seconds prior
to removing from the target tissue.
Hemostasis is obtained by switching
the device to coagulation mode and
continuously pressing the foot pedal to
cauterize the penetrated tissue as the
handpiece is removed from the uterus.
The next fibroid can then be targeted
(Used with permission from Hologic)
in the same manner (Figures 4 and 5).

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Transcervical RFA
FIGURE 6 Components of Sonata System (Sonata System)
The Sonata System enables sonography-
guided RFA of uterine fibroids using an
incisionless, transcervical approach.
The device design consists of a reusable
curvilinear intrauterine ultrasound
probe and a single-use RFA handpiece
that combine into a single unit. The
cervix is serially dilated to 27F to
accommodate the 8.4-mm diameter
of the assembled device (combined
ultrasound probe and RFA handpiece).
The RFA handpiece also comes
equipped with a port for infusing hypo-
tonic fluid into the endometrial cavity
as needed for acoustic coupling. In our
Abbreviations: RF, radiofrequency; US, ultrasound experience, backfilling the bladder with
sterile water can help achieve greater
contrast of adjacent pelvic structures.
FIGURE 7 The Sonata Procedure The device is advanced to the fundus
and a survey is performed to identify
the size and location of fibroids. Once
the surgical planning is complete, the
first fibroid is identified on the screen.
The SMART (Setting Margins on Abla-
tion in Real Time) Guide graphical over-
lay is visible on the ultrasound image.
This provides the user with essential
A. Treatment device inserted B. Graphical guidance software projects information for targeting the treatment
transcervically. The IUUS probe is the ablation guides to target ablation area prior to deploying electrodes and
articulated and fibroids is identified. within fibroid.
initiating the ablation process. The
inner red ellipse indicates the intended
ablation zone. The outer green ellipse
indicates the thermal safety border and
distance from the needle electrodes at
which tissue is safe from potential ther-
mal damage. The ultrasound probe tip is
articulated to 45° or 60°, depending on
the angle needed for optimal visualiza-
tion. The ablation size and depth can
C. Ablation guides control size and D. Electrodes deployed to a mechanical
location of ablation. Tissue outside of stop set to match the ablation guide be adjusted to maximize the target area
the safety border is safe. setting, and ablation performed. and minimize thermal injury to adja-
cent structures. The minimum size is
Abbreviations: IUUS, intrauterine ultrasound 20 mm × 13 mm, and the maximum size is
(Used with permission: Galen DI .BioMed Eng Online.2015 and Brucker et al. IJGO.2014)
49 mm × 42 mm.

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Once the desired ablation zone has


been set, a sharp cannula is deployed FIGURE 8 The Sonata Procedure
from the shaft of the RFA handpiece,
penetrating the fibroid tissue and
stabilizing the device. The first safety
rotation is then performed to confirm
that the thermal safety border is within
the uterine serosa, and that no unin-
tended organs are within the green
ellipse margins. Adjustments to the
anticipated ablation zone are made as
needed. The needle electrodes are then
deployed, and a second safety rotation
is performed. Traction on the tenacu-
lum can help to delineate the serosal
border and assist with visualization
of adjacent bladder and bowel. Once
safety has been confirmed, the device
is held steady, and the footswitch is
pressed to start the ablation process.
The Sonata System operates at
460 kHz. As the RF energy is applied
to the tissue, the tissue temperature
rises and results in subsequent ther-
(Used with permission from Gynesonics)
mal fixation and coagulative necrosis.
Depending on the size of the ablation,
RF energy delivery time ranges from strategy for the procedure’s ablations on how the myomas were mapped (for
1.5 to 7 minutes after reaching the and improves with communication example, our first ablation might be
target temperature of 105 °C. Close about what was done. Mapping is easy. recorded on myoma No. 3 in our map).
observation of the display screen Before any ablations are performed,
should be employed throughout the a systematic ultrasound of the uterus Comparing L-RFA
entire ablation process. Once the is performed and the size, type, and and T-RFA
ablation is complete, the RF generator location of each identified myoma is At their core, L-RFA and T-FA are
will automatically turn off. The needle recorded. For T-RFA, we start with the almost identical with their reliance on
electrodes and introducer can then be ultrasound probe placed at the fundus ultrasound to guide the placement of
retracted, and the ultrasound probe can and directed anteriorly. We then rotate an array of RF electrodes into myomas
be articulated back to 0°. A subsequent the probe clockwise and record all via a sharp, central trocar. However,
ablation can then be performed on the the identified myomas in numerical the design differences necessitated to
same fibroid or on additional fibroids order by their location on a clock with accommodate a laparoscopic vs a tran-
targeted in the same manner (Figures 3 o’clock at the patient’s left. Once this scervical approach imbue each system
6, 7, and 8). is completed at the fundus, we pull the with distinct advantages and disadvan-
probe back to the mid-uterus and then tages when comparing the 2 (Figure
Fibroid mapping lower uterine segment and repeat the 9). In our limited experience, with its
For both procedures, we have found mapping process. Having completed combined intracavitary ultrasound/
that fibroid mapping at the start of the our mapping, we then proceed with electrode device, T-RFA tends to more
procedure helps surgeons develop a the ablations and recording them based easily and efficiently treat myomas that

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FIGURE 9 Comparison of Acessa and Sonata Limitations also include no tissue sam-
pling with current designs. Thus, clini-
Sonata Acessa cians must carefully select patients and
Incisions None 5 mm, 12 mm counsel patients when appropriate on
the very small risk of occult malignancy.
Anesthesia MAC General

Procedure Time RFA and future fertility


While neither L-RFA nor T-RFA is con-
Learning Curve
traindicated for use in women desiring
Myoma Type 0 future pregnancies, as of the writing of
Myomas Types 1, 2, 3, 4 this review, neither L-RFA nor T-RFA
is approved by the FDA for labeling
Myoma Types 5, 2-5 that suggests there are adequate safety
Myomas Type 6 data in this regard. Reflecting that, the
instructions for use for both Acessa
Myomas Type 7
and Sonata clearly state that the safety
Myomas > 10 cm and effectiveness of their technologies
in women who are planning future
Easy/good Mediocre Challenging
pregnancies has not been established.6,7
Nonetheless, an increasing body of data
are smaller (< 8 cm) and closer to the seemingly intuitive, patients need to on pregnancies after both L-RFA and
cavity (FIGO types 1, 2, 3, 4) while the clearly understand that their fibroids are T-RFA suggests that these technologies
L-RFA’s separate laparoscopic electrodes still in situ and that symptom improve- may be compatible with safe future
and ultrasound components allow it to ment will likely be appreciated over time fertility as one might expect based on
better address larger myomas (> 10 cm) rather than immediately. Also, patients experience with the thermal ablation
and myomas that are farther from the whose myomas have an intracavitary of myomas using MRgFUS, which in
cavity (types 6, 7). Both are similar for component should be counseled to 2015 received FDA approval for use in
the treatment of type 5 and type 2 to expect both discharge and passage patients desiring future fertility.8-10
5 myomas. It should be noted that the of tissue as the myoma sloughs off
American College of Obstetricians and ablated material. Summary
Gynecologists (ACOG) Practice Bulletin Contraindications for use of both The introduction of devices capable of
228 (2021) indicated L-RFA and T-RFA L-RFA and T-RFA include current preg- safely delivering RF energy to ablate
are similarly effective.5 nancy, presence of intratubal implants, fibroids offers patients desiring uterine
active pelvic infection, and/or suspected preservation an exciting new array of
Individualizing patient care gynecologic malignancy or premalig- minimally invasive options that were
Although the pathologies of patients nancy. Additionally, these approaches previously unavailable. Both L-RFA
with fibroids may be histologically should be used with caution in patients and T-RFA are in their infancy, and
similar, the approaches to addressing who have coagulopathy, metal implants gynecologists who take care of women
the symptoms related to their fibroids in their lower extremities, or very thin with fibroids should acquaint them-
should be individualized based on the thighs where the electrodes overlap. In selves with these technologies so that
size and location of the fibroids and addition, the safety and efficacy of these patients can be appropriately counseled
each patient’s needs and expectations. approaches have not been well estab- regarding the best options to address
Given the numerous nonextirpative lished in women desiring future fertility their symptoms.
interventions for treating uterine and those with adenomyosis, although
fibroids, it is imperative that clinicians further studies are being conducted to FOR REFERENCES VISIT
manage patient expectations. While better understand these populations. contemporaryobgyn.net/RFA-for-UF

24 CONTEMPOR ARYOBGYN.NE T February 2022

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