UPDATE
HERBERT A. GOLDFARB, MD
The approach to the gynecological patient with abnormal bleeding requires specific diagnosis prior to any consideration of specific therapy. The first intervention after a thorough pelvic and rectovaginal examination should be an endovaginal pelvic ultrasound. Should the uterus be quite large, an abdominal ultrasound may be performed. The endometrial cavity can be best visualized by saline infusion ultrasound. In the absence of fibroids or endometrial polyps, an endometrial biopsy will differentiate anovulatory or dysfunctional bleeding that can be treated with cyclic progesterone. Ovulatory metrorrhagia (secretory) that is recurrent is best treated with an endometrial ablation procedure.
GLOBAL ENDOMETRIAL ABLATION PROCEDURES
The first technique described in 1985 by Goldrath [1] used a bare Nd:Yag laser fiber dragged along the endometrium to destroy the entire lining. Vancaille [2] subsequently described a rollerball electrode via the hysteroscopic resectoscope. Later variants of the procedure utilized a loop electrode to resect the endometrium with the distinct advantage of obtaining tissue for evaluation, and finally some operators finished off the procedure with the grooved electrode at a high power to finely sculpture the cavity.
ThermaChoice. Neuwirth [3] developed a balloon (latex–silicon) device that expanded inside a basically normal (<10 cm) cavity filled with up to 30 cc of D5w pressurized to 160 to 180 mm Hg and heated to 87°C. Distortion of the cavity due to fibroids is a contraindication. This procedure is approved for premenopausal women with menorrhagia due to benign causes for whom childbearing is complete [4].
Novasure. This procedure consists of an impedance–controlled bipolar grid and moisture transfer with controlled and contoured tissue ablation. Treatment time averages 90 seconds. This self-
terminating procedure is based on tissue impedance. Amenorrhea rates of 47% to 58% result. It is approved for patients with polyps and submucous fibroids <2 cm [5,6].
Her Option. A 5.5-mm cryoprobe is placed in the endometrial cavity, and by using abdominal ultrasound guidance, the probe is cooled to -90°C. A 3.5- to 5-cm elliptical ice ball forms. A temp is reached of -20°C 1.5 cm from the edge of the ice ball. The procedure requires 10 to 20 minutes to complete. The bladder is filled to help monitor the procedure via abdominal ultrasound. Inclusion criteria are a cavity <10 cm and uterine volume <300 cc. This procedure is not approved for use with cavitary myomas [7].
Microsulis Microwave. This procedure, recently approved by the FDA, is a non-contact system that uses a microwave generator to develop radiant heat and destroy tissue. Anderson, the lead investigator, has shown that the radiant energy is not limited by cavitary distortion. The uterus is sounded, the radiant wand is placed in the cavity and the intrauterine temperature monitored. The wand is oscillated manually and slowly withdrawn until the endometrium is completely ablated. Results are comparable to those achieved with electrosurgical ablations [8].
Hydrothermablation. Hot water is delivered into the uterine cavity and the process is monitored using a hysteroscope. The cavity should be <10 cm. Fibroids and polyps can be treated with this method. The procedure is microprocessor controlled with visual control of low-pressure gravity fed saline heated to 90°C for 10 minutes. An insulated hysteroscopic sheath 7.8 mm accepts a 3-mm hysteroscope. Results are 54% amenorrhea: 23% oligo, and 14% eumenorrhea [9].
The downside to all these methods is cost, which is approximately $700 to $900 per case, requiring an approved facility for reimbursement, which is at the mercy of the third party carrier. All of the described procedures are effective, with the operative hysteroscopic technique requiring the greatest learning curve.
Uterine Artery Embolization. First reported in 1995 by Ravina [10], uterine artery embolization is a temporizing method in a hemorrhaging patient awaiting a hysterectomy. More than 20 000 procedures have been performed since 1997. Speis [11] reported on 200 patients with fibroids and menorrhagia with improvement in 87% to 91%. Bulk symptoms were improved in 90%. Hospitalization was required in 10.5% of patients. Complications include misplaced polyvinyl particles. Immediate menopause secondary to uterine ovarian anastomosis was experienced by 10% to 15% of patients. Submucosal myomas often prolapse and require hysteroscopic surgery. Other complications include infection, necrosis, pulmonary embolus, and readmission for severe pain. Volume reduction is reported to be 40% to 60%. Volumetric reduction of 10x10x10 cm with a 40% reduction will result in a size of 8x8x8 cm. Therefore, 7 to 8 cm should be a rational size limit for uterine artery embolization.
FIBROID SOLUTIONS
Large multinodular myomatous uteri require surgical intervention. The diagnostic insight provided by magnetic resonance imaging (MRI) can help the clinician make the decision as to what course to recommend. Myomectomy should not only be offered to women wishing to be pregnant. Preserving the uterus for many women has very significant psychological implications. Myomectomy can be performed laparoscopically, and Miller [12,13] has reported on a large series of cases. Most very large myomatous uteri can be made whole with mini-laparoscopic techniques.
Myolysis and Variants. Goldfarb [14] performed Nd:Yag laser myolysis in 1990 and subsequently converted to bipolar electromyolysis, developing sturdy 5-cm needles for the procedure. The present technique was described in the journal of the AAGL in 1995 and subsequently in the Society of Laparoendoscopic Surgeons’ journal in 1999 [15]. The procedure involves undermining identifiable myomas with electrified bipolar needles using the endpoint of cyanosis. Pretreatment with GnRh analog allows a therapeutic trial. Symptoms should abate prior to definitive therapy. Pelvic ultrasound, (MRI), and endometrial biopsy are performed preoperatively. Average volume reduction was 72%. Hysterectomy was avoided in 93.5% of cases. Complications of myolysis (<1%) were minimal. Fibroid degeneration was rare as was infection. Hysterectomy in the myolsis and ablation group was 2.5% in cavities <9 cm.
Cryomyolysis. A cryoprobe is placed laparoscopically into a fibroid via a 5-mm trocar, and an ice ball is created that can extend to 5 cm causing myoma cells necrose. The downside is the expense of the equipment, ranging up to $35000 plus $750 per case. Cryomyolysis has also been described as an MRI-guided procedure. If you add the expense of an MRI to that of the cryoprobe, then you have a procedure whose expense cannot be justified. Electrobipolar myolysis needles sell for about $750 and can be used for years [16,17].
Radiofrequency Myolysis Technique (RITA). After initial puncture, a StarBurst-type probe is advanced into a myoma and with RF coagulation 45D to 50D results in protein denaturation. Cost is similar to that of cryo [18].
Myolysis is effective in select cases of moderate-sized myomas 5-cm to 7-cm after a therapeutic trial with a GnRh agonist. All systems described are effective but cannot compete with Bipolar electromyolysis in price and ease of performance.
OTHER NEW TECHNIQUES
Intravaginal occlusion of the uterine artery described by Istre [19] and Lichtinger utilizes a specialized clamp placed in the uterine fornix. The uterine blood vessels lie within 1 cm to 3 cm from the fornix. A Doppler is attached to the clamp and identifies the occlusion of uterine blood flow. Vessels are pinched for 6 hours. Studies have shown that even after uterine embolization, uterine reperfusion takes place after 6 hours. Postprocedure MRIs have revealed fibroid microcirculation clotting confirming myoma death.
CONCLUSION
Multiple techniques have been described in the ongoing attempt to offer women alternatives to hysterectomy. All have been presented at major meetings and most have been published in refereed journals. It is important to differentiate what we can do from what is cost effective and appropriate for our patients. When all other factors are equal, cost is an important factor. Patients need to be educated and share in their health care decisions.
Address reprint requests to: Herbert A. Goldfarb, MD, 35 Delwick Ln, Short Hills, NJ, 07078, USA.
Tel: 973 744 7470, Fax: 973 744 1274, E-mail: HGoldfarb@NoHysterectomy.com
Herbert A. Goldfarb, MD, is an Assistant Clinical Professor of Ob-Gyn at the New York University School of Medicine and the Director of Gynecological Endoscopy at NYU Downtown Medical Center. In 1986, Dr Goldfarb performed the first video laser laparoscopic surgery in the New York metropolitan area and the first Nd:YAG laser hysteroscopic ablation of the endometrium. In 1990, he pioneered the myoma coagulation (myolysis) procedure, and developed bipolar needles designed to make the procedure easier to perform. Dr Goldfarb, an advocate of alternative solutions to hysterectomy, has authored two books and several scientific articles and book chapters. The No-Hysterectomy Option was written in 1990, with a second edition published in 1997 and Overcoming Fertility was published in 1995.
References
1. Goldrath MH, Fuller FA, Segal S. Laser photovaporization of the endometrium for the treatment of menorrhagia. Am J Obstet Gynecol. 1981;140:14-19.
2. Vancaille T. Electrocoagulation with a ball and resectoscope. Obstet Gynecol. 1989;74:425.
3. Neuwirth RS. Cost effective management of heavy uterine bleeding: ablative methods versus hysterectomy. Curr Opin Obstet Gynecol. 2001;13(4):407-410.
4. Vilos GA, Vilos EC, Pendley L. Endometrial Ablation with a thermal balloon for the treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 1996;3:383-387.
5. Busund B, Erno LE, Gronmark A, Istre O. Endometrial ablation with NovaSure GEA, a pilot study. Acta Obstet Gynecol Scand. 2003;82(1):65-68.
6. Gallinat A, Nugent W, Novasure impedance-controlled system for endometrial ablation. J Am Assoc Gynecol Laparosc. 2002;9(93):283-289.
7. Rutherford TJ, Zreik TG, Troiano RN, et al. Endometrial cryoablation, A minimally invasive procedure for abnormal bleeding. J Am Assoc Gynecol Laparosc. 1998;5(1):23-28.
8. Kanaoka Y, Hirai K, Ishiko O, Ogita S. Microwave endometrial ablation at a frequency of 2.455 GHz. A pilot study. J Reprod Med. 2001;46(6):559-563.
9. Corson SL. A multicenter evaluation of endometrial ablation by Hydro Thermablator and rollerball for treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2001;8(3):359-367.
10. Ravina J, Herbreteau D, Ciraru-Vigneron N, et al. Arterial embolization to treat uterine myomata. Lancet. 1995;346:671-672.
11. Speis J, Ascher SA, Roth AR, Kim J, Levy EB. Uterine artery embolization for leiomyomata. Obstet Gynecol. 2001;98:29-34.
12. Miller CE. Contemporary approach to laparoscopic myomectomy. Oper Tech Gynecol Surg. 2000:5(2):1-11.
13. Miller CE. Myomectomy: comparison of open and laparoscopic techniques. Obstet Gynecol Clin North Am. 2000;27(2):407-420.
14. Goldfarb HA, Myoma coagulation (Myolysis). Obstet Gynecol Clin North Am. 2000;27(2):421-430.
15. Goldfarb HA. Combining Myoma Coagulation with endometrial ablation/resection reduces subsequent surgery rates. JSLS. 1999;3(4):253-260.
16. Olive DL, Rutherford T, Zreik T, Palter S. Cryomyolysis in the Conservative Treatment of Uterine Fibroids. J Am Assoc Gynecol Laparosc. 1996;3(4 suppl):S36.
17. Zreik TG, Rutherford TJ, Palter SF, et al. Cryomyolysis, a new procedure for the conservative treatment of uterine fibroids. J Am Assoc Gynecol Laparosc. 1998;5(1):33-38.
18. Lee BB. Radiofrequency ablation of uterine fibroids; A new minimally invasive hysterectomy alternative. Obstet Gynecol. 2002;99(suppl):9S.
19. Istre O. New approaches to uterine artery occlusion, vaginal technique. Presented at: The Contemporary Management of Uterine Fibroids. April 2003; Santa Fe Springs, CA.
www.Laparoscopy.org The Laparoscopic Surgery Information Source
