What has been your involvement in the development of the Acessa procedure? How many Acessa procedures have you performed? How long have you been performing Acessa?
I first performed radiofrequency ablation of fibroids (Acessa procedure) in 1999 when I became the first surgeon to successfully treat a series of highly symptomatic fibroid patients with this technology.
At that time I used existing instrumentation that was designed to treat liver cancer and modified the procedure and the surgical technique to allow fibroids to be effectively treated. Since then, I have established what is now the methodology for performing and teaching Acessa.
I also designed the new instrumentation to specifically address the treatment of fibroids. This system is what is currently used to ablate fibroids (Acessa Fibroid System). Ultimately, this instrumentation and the methodology I established resulted in obtaining FDA clearance in November, 2012, and has helped many women worldwide to live free of fibroid symptoms.
I have been performing radiofrequency ablation of fibroids for 16 years. During this time I have treated approximately 600 patients and have ablated somewhere between 6,000 and 7,000 fibroids.
How successful is Acessa?
Acessa is highly successful in reducing or eliminating fibroid symptoms. These symptoms include: abdominal distension and enlargement (looking and feeling pregnant), heavy menstrual bleeding, dysmenorrhea (painful menstrual cramping), dyspareunia (painful sexual intercourse), urinary frequency (feeling the need to urinate too frequently), back pain and leg pain, leakage of urine (especially with exercise or straining), fatigue, and gastrointestinal disturbances (difficulty eating, constipation, nausea or premature feeling of “being full”).
In the Phase 3 clinical trials performed for FDA clearance, symptom reduction and bleeding reduction were both clinically and statistically significant. 98% of study subjects reported that they would recommend the procedure to a friend with the same health problem and 94% stated satisfaction with the procedure.
How do I select a physician to perform Acessa?
Since Acessa is a new procedure, most gynecologists have yet to receive Acessa training. And most that have been trained are still gaining experience in performing it. This will definitely change over time since more and more Acessa cases are being performed every day.
In addition, the Acessa procedure is a skill dependent procedure. The results that you will experience depend upon your surgeon’s skill, knowledge of, and experience with this procedure.
Therefore, my advice is that if your case of fibroids may be a more difficult one, better results may be obtained by choosing a physician with more experience and one who treats complicated cases regularly.
What is your complication rate?
The Acessa procedure is a safe, minimally invasive procedure. My operative complication rate is less than 1%. The operative complications that have occurred are related to laparoscopy (looking inside the abdomen with a scope), not related to ablation of the fibroids.
These complications have been minor, and have generally only needed additional observation, not additional surgery or procedures. However, there are risks to any procedure and these risks should be thoroughly discussed with you before you consent to have any type of surgical procedure, even one as safe as Acessa.
How long does it take the fibroids to reabsorb? Will taking hormones during this time affect the fibroid disappearance?
After ablation, the fibroids are immediately softer, and continue to soften over time. Also, the reabsorption process begins immediately. By 3 months, the reabsorption rate is about 20-25% of the total amount that will be reabsorbed. By 6 months, 80% of the total resorption has occurred.
Reabsorption generally then continues slowly until one year post ablation. Some myomas will disappear entirely and some will have a small residual of ablated, broken-down fibroid material. This material is almost gelatinous, inert, sterile, and not harmful or biochemically active.
While no studies have examined this point, I have not observed hormonal treatment to affect the process of fibroid absorption.
What is the recurrence rate or failure rate of the procedure?
In the Phase 3 pivotal clinical trial, the procedures were performed by physicians who had basic training and experience in 2 or 3 procedures.
The failure rate in the trial at one year was one study subject out of 135 (0.7%). At three years, the failure rate was a cumulative 11%, which is very low for a uterine conserving procedure.
Interestingly, about one half of the patients who failed had a condition called adenomyosis, which also causes heavy bleeding and painful menses. Patients with adenomyosis were to have been excluded from the trial.
I believe that with more physician experience, the failure rate would have been even lower, since my failure rate at one year has been <1%, and at three years 2-3%.
What would be the advantages and disadvantages of this method vs. more traditional embolization or myomectomy?
The main differences between Acessa and myomectomy are: number of fibroids treated, damage to the uterus, postoperative adhesions, blood loss, operative approach (laparoscopic vs open, laparotomy).
Compared to myomectomy, Acessa:
- Treats more fibroids since laparoscopic ultrasound is used (which has been shown to detect many more fibroids than preoperative vaginal ultrasound or MRI); I can find fibroids as small as 2 mm in diameter with laparoscopic ultrasound and treat them (preventing future enlargement and production of symptoms). With laparoscopic myomectomy, the average number of fibroids removed is between 2-4. On average, I now treat approximately 15-20 fibroids per case.
- Myomectomy requires cutting through normal uterine muscle to get to the fibroids. After removal of the fibroid, suturing of the defect or hole is necessary to stop bleeding and repair the uterus. Both of these processes damage normal uterine muscle fibers. The result is a weaker, scarred muscle wall. It is fairly common to recommend a cesarean section for patients who conceive after myomectomy.
In contrast, Acessa uses a small needle to penetrate through the muscle wall and enter the fibroid. It ablates only the fibroid, not the normal muscle wall. There is therefore essentially negligible damage to the uterus. This reasoning is why patients who have conceived after Acessa are allowed to labor and to have vaginal deliveries.
- The postoperative adhesion rate after myomectomy is generally recognized as 80%. Adhesions may produce infertility, pelvic pain, and gastrointestinal obstruction or symptoms. In my experience adhesions after Acessa are definitely rare if no other procedures are performed at the time of Acessa.
- With myomectomy, blood loss can be significant as the muscle wall is vascular, and fibroids are surrounded by peripheral blood vessels.
With Acessa, only a needle is utilized to penetrate the wall and fibroid, and coagulation is used to coagulate the needle track upon removal. To date, no patient has required a transfusion due to blood loss occurring during the Acessa procedure.
- Most myomectomies are performed by open laparotomy (abdominal incision as with cesarean section). Acessa only requires two small incisions, one 5 mm (usually in the umbilicus) and one 10 mm and one to four needle puncture sites (as when having blood drawn). Laparoscopic myomectomy usually requires four incisions.
Compared to uterine artery embolization:
- Acessa treats only the fibroids whereas embolization treats the entire uterus (decreases blood flow to the entire uterus).
- Acessa does not involve injection or placement of permanent beads injected into the uterus by an interventional radiologist.
- Acessa is effective in the treatment of larger fibroids (whereas embolization is not generally recommended with larger >8 cm fibroids).
- There is no post-embolization syndrome (fever, abdominal pain, nausea and elevation of the white blood count) as there is after UAE.
- There are no complications of ovarian failure (premature menopause), passage of fibroids vaginally up to 3 years later, risk of death of the uterus, risk of migration of particles causing damage to other organs (labia, ovaries), or significant pain (my last two patients did not take any medications for postoperative pain; strong narcotics are the rule after UAE).
- The published failure rate after UAE is much higher at 1, 3, and 5 years than the failure rate after Acessa (when performed by me).