Fibroid Treatments Demystified, Part II: Radiofrequency Ablation (Acessa Procedure)

How Radiofrequency Ablation (RFVTA) Works

Acessa’s RFVTA is performed laparoscopically in an outpatient setting, with the patient under general anesthesia. The surgeon makes two tiny abdominal incisions (no wider than 1/4 inch), and inserts a scope, which allows for visualization of the uterus, followed by a laparoscopic ultrasound probe which is used to detect fibroids not seen through the scope. Once fibroids have been located, the surgeon uses a special probe (the Acessa handpiece) with a retractable electrode array to directly apply a controlled volume of heat to the fibroid. Once treated with heat, the destroyed fibroid tissue shrinks and is typically reabsorbed by the body. The treatment targets only the fibroid tissue, so healthy tissue in surrounding organs is unharmed.

Treatment Outcomes

Clinical research has shown radiofrequency ablation to be very effective in shrinking or completely eliminating fibroids. The use of laparoscopic ultrasound reduces the risk of symptom recurrence by allowing the physician to find and treat all fibroids present in the uterus, not just the ones that were identified through previous diagnostic imaging. Study data from the team of Chudnoff et. al indicate that, at 12-months post-treatment, 94% of RFVTA patients had seen lasting reduction in symptoms and improved quality-of-life, and device-related complications were low (3.6%). A study by Guido et al. affirmed the findings of Chudnoff’s team and reported that 6 of 124 patients (4.8%) required surgical reintervention for fibroid-related bleeding between 12 and 24 months post-treatment. After three years of follow-up in the same group of patients, Berman et al. reported that symptom reduction and quality of life were sustained.

Limited data exists regarding fertility and pregnancy outcomes related to RFVTA, so RFVTA cannot yet be indicated for women seeking pregnancy. Commenting on the results of an early feasability study, Lee et. al reports, “future pregnancy and potential vaginal delivery post RFVTA are being explored in three trials, respectively, in Canada, California, and Germany.”

Radiofrequency ablation is a uterine-sparing procedure, and it is a less invasive surgical option for women who are looking to avoid hysterectomy. Since it is one of the newer fibroid treatments available, women may be challenged to find doctors who are trained in the procedure. However, as awareness and demand for the procedure grows, additional doctors will seek training in the technique of radiofrequency ablation for the treatment of uterine fibroids. In a 2013 article profiling Acessa’s RFVTA, Dr. James Macer commented, “patients are increasingly aware of uterine sparing treatments for symptomatic fibroids. Women seek conservative procedures to avoid the risks and extended recovery times commonly associated with major surgery.”

 

SOURCES:

  1. American Society for Reproductive Medicine, “Treatment of Uterine Fibroids”, ReproductiveFacts.org: 2011. Retrieved May 25, 2015, from http://www.reproductivefacts.org/FACTSHEET_Treatment_of_Uterine_Fibroids/
  2. Berman, J.M. et al. “Three years’ outcome from the Halt trial: a prospective analysis of radiofrequency volumetric thermal ablation of myomas,” Journal of Minimally Invasive Gynecology. 2014; 21(5):767-774
  3. Chudnoff, S. et al. “Outpatient procedure for the treatment and relief of symptomatic uterine myomas”, Obstetrics and Gynecology. 2013; Vol. 121(5):1075-1082
  4. Guido, R. et al. “Radiofrequency volumetric thermal ablation of fibroids: a prospective, clinical analysis of two years’ outcome from the Halt trial”, Health Quality Life Outcomes. 2013; Vol. 11(139):1-8
  5. Lee, B. et al. “Ch. 9: Radiofrequency Volumetric Thermal Ablation of Symptomatic Uterine Fibroids: The Acessa Procedure.” In Leiomyomas: Risk Factors, Clinical Manifestations and Treatment Options, edited by A. Al-Hendy and S. Salama, p. 186-190. Nova Science, 2015.
  6. Macer, J. “For uterine-sparing fibroid treatment, consider laparoscopic ultrasound-guided radiofrequency ablation”, OBG Management. Nov. 2013; Vol. 25(11):50-55

 

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Fibroid Treatments Demystified, Part I: Uterine Artery Embolization

Many women of reproductive age seek uterine-sparing methods of fibroid treatment: uterine artery embolization (UAE), sometimes called uterine fibroid embolization (UFE), is one of the hysterectomy alternatives available to women with fibroids.

How UAE Works

Uterine artery embolization (UAE) is a minimally-invasive procedure that is performed by an interventional radiologist. UAE treats fibroids “in situ”, meaning ‘in place’, by cutting off their blood supply and causing them to die from what is known as “ischemic necrosis”. To do so, an interventional radiologist inserts a catheter through the femoral artery (located in the upper thigh) and into the uterine artery, which supplies blood to the uterus. A type of material known as an “embolic agent” is then injected through the catheter, into the blood vessels that supply blood to the fibroids. Typical embolic agents include polyvinyl alcohol (PVA), gelatin sponge plegets, or gelatin microspheres. Once injected, particles of the agent block the blood supply to the tiny arteries that carry blood to the fibroids. Without adequate blood flow, the fibroids shrink and, ultimately, die.

Treatment Outcomes

UAE is successful in diminishing fibroids and associated symptoms in an estimated 85% of cases. For patients who are looking for a minimally invasive fibroid treatment, embolization’s non-surgical approach is appealing. The recovery period is generally short, though it is notoriously painful. Fred Burbank, author of Fibroids, Menstruation, Childbirth, and Evolution, states “nearly all women who undergo [UAE] have severe pelvic pain generally lasting 4 to 6 hours, but others, lasting up to a day” (p.124). The American Society For Reproductive Medicine also notes, “patients typically experience several days of pain after the procedure”. Many women are hospitalized overnight for pain control.

The incidence of fertility-compromising outcomes has called into question the appropriateness of the procedure for women seeking to get pregnant, though additional research is needed to assess the risk. Here’s what researchers do know: once the embolic agent has been injected, the particles stay in the body. In some cases, those particles can migrate to the ovarian blood supply, compromising fertility and triggering the onset of menopause. Burbank describes the physiological process after injection of the embolic agent:

Anatomically, connections exist that allow particles injected into the uterine artery to reach any structure supplied by branches of the uterine artery. The physiology of blood flow from the uterine artery to its branches determines the relative number of particles that reach the myometrium, fibroids, and the ovaries. Injected particles are indifferent to where they go.(p.111) A significant number of women who undergo UAE become amenorrheic (cease to have periods)as a result of the procedure; however, research has indicated that younger patients see fewer complications of this nature. A longitudinal study by Goodwin et. al found that, at 36 months post-procedure, approximately 85% of patients had no intervention but 28.6% of UAE patients were amenorrheic with the largest proportion(78.9%) of patients over the age of 45.

UAE isn’t right for everyone: women with fibroids should talk to a gynecologist about the risks and benefits of UAE and other available fibroid treatment options, before seeking treatment. However, as one of the less invasive methods for treating fibroids, UAE helps meet the growing demand for alternatives to hysterectomy.

SOURCES:

  1. American Society for Reproductive Medicine, “Treatment of Uterine Fibroids”, ReproductiveFacts.org: 2011. Retrieved May 25, 2015, from http://www.reproductivefacts.org/FACTSHEET_Treatment_of_Uterine_Fibroids/
  2. Goodwin, S. et al./Fibroid Registry for Outcomes Data (FIBROID) Registry Steering Committee and Core Site Investigators.”Uterine Artery Embolization for the Treatment of Leiomyomata: long term outcomes from the FIBROID Registry”, Obstetrics & Gynecology, Jan 2008; Vol 11(1):22-33
  3. Burbank, F. Fibroids, Menstruation, Childbirth, and Evolution, p. 110. Wheatmark, 2009. Tucson, AZ.

 

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The Future of Fibroid Research

Hysterectomy may have been the prevailing standard for treating uterine fibroids in the past, but times have changed. Abundant research on the subject of fibroids has yielded new advances in treatment modalities for the condition, fueled by the widespread demand from fibroid patients for uterine- and fertility-sparing treatment options. Thanks to this research, numerous alternative therapies are now available for women with symptomatic fibroids, and awareness of non- and minimally-invasive fibroid treatment options is growing among both patients and health care providers. As fibroid research continues, we can expect the number and availability of alternative treatments to further expand.

“It is extremely important for women to know the options available to treatment of uterine fibroids,” says Dr. Elizabeth Stewart, M.D., Chair of Reproductive Endocrinology at Mayo Clinic. “Equally important,” she adds, “is the need to continue to study fibroids to assist in developing better treatments.” The Mayo Clinic is endeavoring to do just that, launching a massive research effort to compare existing treatments for uterine fibroids. With funding from the Patient-Centered Outcomes Research Institute (PCORI) and the Agency for Healthcare Research and Quality (AHRQ), researchers from several institutions, including Duke University, University of California – San Francisco, and Mayo Clinic are establishing an observational registry that includes 10,000 women with diagnosed uterine fibroids. The research initiative, called COMPARE-UF, will look at the factors that most heavily influence the treatment choices of its women participants and will evaluating all available treatment options in terms of those priorities. Recognizing the importance of uterine-sparing and fertility-sparing therapies that has been widely expressed by women with fibroids, researchers will look at a variety of hysterectomy alternatives, including minimally invasive procedures like radiofrequency ablation.

Beyond the COMPARE-UF registry, a slew of other studies are focusing on alternatives to hysterectomy in the treatment of fibroids. Researchers at UCSF, Duke University, and Mayo Clinic are currently conducting research to compare two uterine-sparing procedures, uterine artery embolization (UAE) and MR-guided focused ultrasound. Their “FIRSTT” study, funded by the National Institute of Health, is the first in the U.S. to compare UAE and MR-guided focused ultrasound. The researchers will look at the differences between the two treatments in terms of symptom relief, side effects, impact on quality of life, and recurrence/re-intervention.

Another major fibroid treatment study is also underway at UCSF: the ULTRA study is being conducted to help patients and doctors better understand how radiofrequency ablation (Acessa Procedure) changes fibroid symptoms, affects fertility and pregnancy, and impacts the need for additional fibroid treatment in the future. While the procedure has already received FDA clearance and is being performed with increasing frequency, studies of this nature provide the kind of additional data that facilitate acceptance by major health insurers.

The increasing focus by medical researchers on hysterectomy alternatives stands to benefit more than the patients; the medical community and the U.S. healthcare system could see a significant, positive, long-term impact from the shift. According to Dr. Jay Berman of Wayne State University’s School of Medicine, the medical community’s demand for safer, less invasive and less expensive treatment options is growing. He explains, “while hysterectomy will continue to be a option for the appropriate patient, some alternative techniques appear to save the cost of hospitalization, are organ-sparing, have low re-operation rates, and result in high patient satisfaction… It behooves the decision-makers to look at the overall acceptability of less-invasive, outpatient treatments that keep hospital beds for the sickest of our patients and reduce the demand for future healthcare services.”

For patients and physicians alike, the improved understanding of the condition and its treatment that research produces translates to improved quality and availability of treatment options. Having options is essential, because fibroid treatments are not “one-size-fits-all”. While hysterectomy’s consequences and general invasiveness make it an undesirable approach to many women seeking fibroid treatment, hysterectomy is still the most medically appropriate approach in certain cases. Mayo Clinic’s Dr. Stewart believes the decision on how to best treat a woman’s fibroids should be guided by the nature and severity of her symptoms; her age and health history; and the size, number, and location of the fibroids themselves. The key for women with fibroids is awareness of all the available treatment options, and —thanks to continuing research on the subject —those options will continue to improve in the future.

Sources:

  1. Rosen, P. “The Endangered Uterus”, More.com Dec 2008/Jan 2009; 117-121, 157-158
  2. “Exploring Treatment Options for Women with Fibroids.” Medical Xpress. April 23, 2015. Retrieved May 7, 2015. http://medicalxpress.com/news/2015-04-exploring-treatment-options-women-fibroids.html.
  3. Berman, Jay M. “Alternative Procedures For the Treatment of Symptomatic Fibroids”, Wayne State University School of Medicine

 

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