Posts

New Directions in Fibroid Treatment: The Acessa Guidance System

 

Fibroids have just become easier to treat. Why? Because a new application for an old technology has given practitioners of radiofrequency ablation the ability to target them with unprecedented precision.

Earlier this year, Acessa Health (the company behind Acessa Procedure), introduced the Acessa Guidance System¹. Developed as a supplement to the existing Acessa System, Guidance leverages electromagnetic tracking technology to provide precise fibroid targeting capabilities. In simple terms, it’s like a GPS system for the uterus.

How The Acessa Guidance System Works

Acessa Procedure, a minimally invasive method of treating fibroids that’s also known as radiofrequency ablation, treats symptomatic uterine fibroids laparoscopically, without harming the healthy uterine tissue that surrounds them. The procedure involves an instrument known as the Acessa handpiece, which applies focused radiofrequency energy directly to the fibroid, destroying the fibroid with heat (a process known as “ablation”). The Guidance component adds an electromagnetic tracking function to the handpiece, which, when coupled with ultrasound, provides a real-time view on the device’s trajectory to the targeted fibroid.

A Novel Use For Tried-and-True Technology

Electromagnetic tracking technology is not new. However, until the release of Acessa Guidance, the technology had never been applied in the field of gynecology. This application helps overcome a longstanding challenge in treating fibroids: efficiently accessing small and hard-to reach fibroids.

Historically, gynecologic surgeons have identified fibroids through pre-operative imaging. A variety of imaging techniques – including transvaginal ultrasound, sonohysterography, MRI, and diagnostic hysteroscopy – can be used to provide surgeons with a snapshot of the existing fibroid tumors. While they vary in cost and convenience, the fibroid imaging techniques have one thing in common: the images they generate are static.

Typically, surgeons use reference images to determine how to best reach the fibroid during surgery. In real time, however, movement can occur that makes a certain fibroid inaccessible by a path that appeared clear in the reference image. In the context of the previous analogy that likened Acessa Guidance to GPS, a reference image is the functional equivalent of a printed map.

In a recently published feasibility study, gynecologic surgeon Dr. Don Galen explains, “reference images…do not provide real-time, intraoperative findings. Lack of real-time imaging is especially problematic for the surgeon if the patient has symptomatic intramural fibroids or intramural fibroids abutting—but not distorting—the endometrium.”

Before its introduction to gynecology, electromagnetic tracking technology had already proven its value in other medical applications. Image guidance systems have been widely adopted for use in neurosurgical, hepatobiliary, and endoscopic procedures, among others, with positive results. Referring to a study of the technology’s application in hepatobiliary surgery, the Galen study noted: “These surgeons tested their ability, time, and mental workload when targeting the analog tumor under different controlled conditions. The guidance system significantly reduced the number of required needle withdrawals and repositionings, and…their mental workload.”

Guidance For Treating Fibroids

Galen has seen similarly positive results since the technology has been incorporated into the Acessa System to help with the targeting of fibroid tumors. He found the dynamic animation to be helpful in the process of targeting each fibroid, reaching the fibroid quickly, and visualizing the positions of the transducer and handpiece within the pelvic cavity during surgery. The feasibility study concludes:

Its significant application is in the targeting of those fibroids not readily visualized on laparoscopy (such as intramural fibroids) prior to ablation… Consequently, any technology that facilitates the targeting and treating of otherwise hard-to-reach fibroids is of benefit to the gynecologic surgeon as well as to the patient’s wellbeing.

With powerful image guidance technology enhancing an advanced, minimally invasive fibroid treatment procedure, treatment for fibroids is clearly moving in the right direction.

 

¹Patented AIM™ guidance software provided by InnerOptic Technology, Inc.

SOURCES:

Galen, D. “Electromagnetic image guidance in gynecology: prospective study of a new laparoscopic imaging and targeting technique for the treatment of symptomatic uterine fibroids”, BioMedical Engineering Online. Oct. 2015; 14:90.

“Halt Medical, Inc. Announces The First Acquisition Of Acessa Guidance System”, PR Newswire. June 27, 2016.

Metson, R. “The Role Of Image Guidance Systems for Head and Neck Surgery”, JAMA Otolaryngology. Oct. 1999; 125(10): 1100-1104

 

 

LI-00-0525-A

 

Endometrial Ablation vs. Radiofrequency Ablation: What’s The Difference?

 

The term “ablation” refers to a process by which tissue is destroyed, typically using either heat (thermal ablation) or cold (cryoablation). Ablative technologies are used to treat numerous medical conditions, including gynecological issues. We often hear of two procedures in particular, endometrial ablation, and radiofrequency ablation, and many people confuse the two treatments. Don’t let the similar names deceive you though: while both procedures leverage ablative technology, they are very different in their applications. To clear up the confusion, here’s a rundown on the defining characteristics of the two ablation therapies.

Endometrial Ablation (EA)

How EA Works
Endometrial ablation is typically used to treat prolonged, abnormal uterine bleeding. It does so by ablating the lining of the uterus, known as the endometrium, permanently destroying the tissue. There are several different methods of endometrial ablation: these include freezing (cryoablation techniques), directly applying heat from fixed-frequency microwaves or radiofrequency energy; and using hot fluid through techniques like balloon endometrial ablation.

In EA, treatment is limited to the endometrial layer, the surface tissue that lines the uterine cavity, and the basalis layer, where the endometrial tissue originates. Destroying the basalis layer prevents new tissue from growing, thereby reducing or eliminating menstrual bleeding.

EA procedures are performed in an office or hospital setting, usually with the patient under conscious sedation. Patients typically go home the same day, and full recovery takes about 1-2 weeks, depending on the specific procedure.

Outcomes
Endometrial ablation is used to control prolonged, abnormal vaginal bleeding. EA is most appropriate for patients that have completed childbearing, who have not seen results from other treatment approaches, and who are seeking an alternative to hysterectomy.

In most cases, EA meets its objective: an estimated 9 out of 10 women have lighter periods or no periods after undergoing the procedure. However, it’s difficult to predict whether a woman’s bleeding will stop completely. Estimates regarding the incidence of amenorrhea (the absence of menstrual bleeding) after EA vary widely from one study to the next, but it’s typically estimated to fall between 20% and 50%. A study by El-Nashar et al. asserted that the likelihood of amenorrhea occurring after EA depends on the type of ablative technology used, as well as patient characteristics like age and uterus size. Regardless, amenorrhea is not a guaranteed outcome. “If… a woman’s goal is amenorrhea, hysterectomy is the only reliable op¬tion,” reports Dr. Joseph Sanfilippo in an update to the medical community on EA-related developments.

It is important to note that endometrial ablation is not indicated for the treatment of uterine fibroids; any destruction of fibroids in the process of ablating the endometrium is incidental. Fibroids that grow partially or entirely within the walls of the uterus (known as intramural fibroids), as well as those growing outside the uterus (subserosal fibroids), are not reached during ablation. Those that protrude into the uterine cavity (submucosal) are sometimes shaved down hysteroscopically before ablation; however, if the fibroid originates below the basalis layer of tissue, it cannot be completely eradicated during ablation and may grow back, following the procedure.

Radiofrequency Ablation (Acessa Procedure)

How RFVTA Works
Radiofrequency ablation (short for “radiofrequency volumetric thermal ablation”, or RFVTA) is a specific ablation technique that is used to treat uterine fibroids in a procedure known as Acessa. In the Acessa procedure, a controlled volume of heat is applied directly to the fibroid, killing the tissue of the fibroid while leaving healthy surrounding tissue unharmed. Once the fibroid is destroyed, the dead tissue is simply reabsorbed by the body.
In performing RFVTA, a scope and a laparoscopic ultrasound probe are inserted through the abdominal incisions. Using the scope in conjunction with the ultrasound probe allows the operating physician to precisely pinpoint the fibroids’ location. Once the fibroids have been located, the surgeon uses a special tool with a retractable electrode array (the Acessa handpiece) to ablate the fibroid with radiofrequency energy.
RFVTA is performed in an outpatient setting. The surgery is minimally invasive: with the exception of two tiny incisions (no wider than 1/4 inch) on the abdomen, there is no cutting or suturing of uterine tissue. Patients go home the same day and return to normal activities within 2-3 days.

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. At 36 months post-treatment, 90% of patients needed no additional fibroid treatment. Though objectively measured bleeding at 12 months of follow up decreased in 82% of the women treated with RFVTA, the goal of treatment was not to destroy the endometrium or induce amenorrhea but merely to treat the fibroids.
***
In the field of gynecology, ablation techniques can be used in addressing multiple conditions but it’s important to understand the difference between the technologies. Radiofrequency ablation with Acessa is an effective method for treating only the uterine fibroids without harming the rest of the uterus, whereas endometrial ablation effectively controls abnormal vaginal bleeding by directly ablating the lining of the uterus. Their usefulness is entirely related to their objective, and despite the commonality of a name, these procedures are very different in the objectives they serve.

SOURCES:

  1. American Society for Reproductive Medicine, “Endometrial Ablation”, ReproductiveFacts.org: 2011. Retrieved May 28, 2015, from http://www.reproductivefacts.org/uploadedFiles/ASRM_Content/Resources/Patient_Resources/Fact_Sheets_and_Info_Booklets/endoablation.pdf
  2. El-Nashar, S.A. et al. ” Prediction of Treatment Outcomes After Global Endometrial Ablation”, Obstetrics & Gynecology, Jan. 2009; 113(1): 97–106. doi:10.1097/AOG.0b013e31818f5a8d.
  3. Sanfilippo, J. “Update: Options in Endometrial Ablation”, Supplement to OBG Management, Dec. 2009
  4. Berman, J.M. et al. “Three Years’ Outcome from the Halt Trial: A Prospective Analysis of Radiofrequency Volumetric Thermal Ablation of Myomas”, The Journal of Minimally Invasive Gynecology, 2014.

LI-00-0470-A