Comparison of Radiofrequency Ablation of Fibroids (Acessa™ Procedure) and Uterine Artery Embolization (UAE)
Uterine Artery Embolization Procedure
The procedure is performed by an interventional radiologist. If complications occur, the patient is cared for by a gynecologist.
Under sedation, an incision is made over the femoral artery and a catheter is inserted. Under fluoroscopy (real time, X ray imaging) the catheter is maneuvered into the left and then the right uterine artery. Permanent synthetic beads (usually made of poly vinyl alcohol PVA) are then injected which enter the uterus and block blood flow, causing ischemia or lack of oxygen throughout the uterus.
Fibroids are more susceptible to ischemia, therefore they die from lack of oxygen. The uterus is able to survive by expansion of smaller surviving blood vessels and growth of new ones. Patients are often observed overnight, but may be sent home with oral narcotics for pain after an observation period of 4-6 hours.
Since UAE is significantly less effective in treating larger fibroids, the procedure is not indicated in their presence and these patients are routinely excluded. Therefore, the patient populations are inherently unequal. Acessa has been successfully performed on fibroids of 12 – 14 cm with good results.
The inability to catheterize the uterine arteries occurs in 1-2% of cases and therefore UAE cannot be performed. Thus far, Acessa has been performed in over 500 cases without a procedural failure.
UAE usually requires administration of IV narcotics overnight for pain control, followed by oral narcotics. After Acessa, patients usually take a cox-2 inhibitor and, rarely, a mild narcotic for breakthrough pain should it occur.
Short Term Complications
Spies has reported a 10.5% short-term complication rate (30 days postop). Since elimination of the UTI’s following Acessa by using prophylactic antibiotics, the short-term complication rate is 2-5%.
- Post-embolization syndrome 2-7%
- Catheter Failure 1-2%
- Premature Ovarian Failure 2-15% (26% in pts >50 yr of age)
- Amenorrhea 14% @ 1 yr, 42% @ 5 yr.
- Myoma passage 1.6 – 7%, occurs up to 3 yr post UAE
- Uterine, Labial necrosis <1%
For a more detailed listing of possible complications, visit post UAE.
- Post-embolization syndrome 0%
- Procedure Failure 0%
- Premature Ovarian Failure 0%
- Amenorrhea 0%
- Myoma passage 0%
- Uterine, Labial necrosis 0%
The complications of Acessa are limited to those related to anesthesia and laparoscopy. They have been reversible and short term. Total adverse event rate was 5.6%.
Short and Long-Term Efficacy
ACOG has stated that UAE is effective in the short term. Symptom improvement generally runs around 85-90%. At 12 months, Spies reported 87% of patients were improved, 7% had failed (underwent major intervention) and an additional 5% were not improved for a 12% failure rate.
By 3 years, 83% were improved, 14% had failed, and 4% were not improved for an 18% failure rate. By 5 years 73% were improved, 5% were not improved and 20% had failed for an overall 25% failure rate. Broder et al reported a 29% failure rate 3-5 yr post UAE.
Average missed days of work for UAE is 10.7. Acessa patients miss an average of less than 5 (range 0-10).
Post UAE Pregnancy
Increased rate of malpresentation, cesarean deliveries, postpartum hemorrhage, preterm labor. While ACOG has not officially stated that pregnancy post UAE should not be recommended, obstetricians and gynecologist are not recommending UAE for those who desire future childbearing because of the initial reports of increased complications.
There have been 10 pregnancies after Acessa with one spontaneous miscarriage, and 9 succesful deliveries, (5 cesarean sections and 4 vaginal deliveries) with one set of twins for a total of 10 healthy newborns.
Post UAE Adhesions
50% of patients who fail UAE and undergo laparotomy or laparoscopy are found to have pelvic adhesions. Post Acessa adhesions are rare.
UAE has a comparable short-term symptom improvement rate when compared to Acessa’s short-term resolution rate. However, the populations differ as patients with larger fibroids are excluded from UAE.
The complication rate is significantly higher with UAE. In the Registry study, 29% reported an unanticipated adverse event. Ovarian failure and amenorrhea are known and frequent complications of UAE. Furthermore, the procedural pain is significantly greater with UAE.
The performance post UAE in pregnant patients is very concerning, while it is anticipated that Acessa patients will have good outcomes (thus far reported: 9 term uncomplicated deliveries and one miscarriage). Both mid and long term failure rates with UAE are greater as well.
In the presence of these facts, Acessa compares very favorably to UAE.
Spies, JB et al. The FIBROID Registry, Symptom and Quality of Life Status 21 Year After Therapy. Obstet Gynecol 2005; 106: 1309-18.
Spies, JB et al. Long-Term Outcome of Uterine Artery Embolization of Leiomyomata. Obstet Gynecol 2005; 106: 933-9.
Broder, et al. Comparison of Long-Term Outcomes of Myomectomy and Uterine Artery Embolization. Obstet Gynecol 2002; 100 (5 Pt 1): 864-8.