Ablation versus Hysterectomy for the Treatment of Mmenorrhagia
Robert S. Neuwirth, M.D,
Babcock Professor of Obstetrics/Gynecology, Emeritus, Columbia University, Director of Hysteroscopic Surgery, St. Luke's - Roosevelt Hospital Center, New York City, U.S.A.
Menorrhagia and associated conditions such as uterine f?broids are some of the most common problems seen by gynecologists. It is estimated that 20% of women suffer from these conditions (l). The diagnostic work-up should rule out cancer and coagulation problems. Other causes are amenable to hormonal therapeutic trials or a variety of other more interventional treatments provided no contraindication exists. Costs and safety are prime considerations. The interventional options include uterine embolization, endometrial ablation and various forms of hysterectomy.
Uterine embolization is the most recent interventional treatment introduced. It clearly has been successful in several reports (2, 3). However it is too early to define the categories of patients best indicated and contraindicated. It was introduced primarily as a treatment to reduce myomas but has had success in control of menorrhagia. The complication rates are unknown at this time. A registry of cases with follow-up is needed to answer these questions,
Hysterectomy indisputably cures menorrhagia and uterine f?broids. It has been practiced for one hundred years. Curettage as a therapy has been ineffective for menorrhagia or fibroids unless a polyp was removed. Its advantage was low risk and its roots are its effectiveness for control of bleeding from abortion. Hysterectomy has been and remains the primary treatment in patients with menorrhagia who did not respond to hormonal therapy. Although a variety of types of hysterectomy have been introduced recently, the data on complications, costs and length of stay are relatively limited. The information suggests that costs and hospital stay are about the same (4.). Clearly the skills required are less for supracervical hysterectomy than for laparoscopic or vaginal hysterectomy. As all these procedures are skill dependent and case selection is also a confounding factor, it is difficult to sort out complication rates except in narrowly defined circumstances.
However. it is safe to say that for all forms of hysterectomy the complication rate is higher than for hysteroscopic ablation and certainly higher than for second generation ablation methods where there has been sufficient breadth and duration of experience to determine rates. The death rate for hysterectomy for benign disease is about one per one thousand cases (5). The death rate from hysteroscopic ablation is about one in five thousand, and the death rate for Thermochoice balloon ablation in over 100,000 cases is zero (6). Major complications from hysterectomy including pulmonary embolism, hemorrhage, anesthesia, visceral injury, urinary retention and peripheral nerve injuries are
about 8 per hundred. The immediate direct costs of hysterectomy are about double hysteroscopic endometrial ablation, even if repeat procedures for failure are included (7).
Indirect costs, such as lost work, and assistance during recovery are difficult to analyze but probably favor ablation. Long term post- treatment data can modify the analysis but is generally rot available or soft. For example, the costs of endometrial cancer following ablation have not been reported as yet, The incidence of endometrial cancer after ablation appears to be low as there are very few reports in the literature and those cases are clustered in high risk patients for endometrial cancer (8). A long term follow-up focused on endometrial cancer is undervay,
The long term sequelae of hysterectomy also require consideration. Tulandi reported (9) recently a l .6% incidence of bowel obstruction from adhesions as a late complication of hysterectomy. An incidence as high as 3% has been reported. Urinary incontinence surgery appears to be more frequent in women who have undergone hysterectomy. Olsen reported (10) 37% of women having a primary procedure for urinary incontinence and/or pelvic organ prolapse had a prior hysterectomy not for prolapse. Serious long-term risks following a procedure must be considered, particularly now that there are reasonable altematives. Such data may change the cost or health risk analysis for a patient when comparing hysterectomy to ablation.
The third category of intervention for menorrhagia is endometrial ablation. Follwing introducticn of the resectoscope to treat submucus fibroids, Goldrath in 1981 reported (11) on laser ablation of the endometrium under hysteroscopic control. De Cherney reported (12) using the resectoscope for the same purpose in 1984. It was soon evident that hysterescopic thermal ablation of the endometrial was effective in the short run. In 1991 our group published (13) a ten year follow-up study covering 1978 to 1988 which showed a 91% chance to avoid a second surgery in a cohort study using a life-table analysis. Magos reported (14) a prospective five year trial in 1996 confirming the long term effectiveness of endometrial ablation.
These reports created interest in ablation as a treatment for menorrhagia in lieu of hysterectomy. Comparison of laser and electrosurgical hysteroscopic ablation showed similar amenorrhea, repeat surgery and patient satisfaction rates. Pre-treatment with GRnH agonists improved success. Complications are perforation, visceral burns, and problems related to fluids used to distend the uterine cavity which can be absorbed.
Pulmonaiy edema from fluid overload and hyponatremia with convulsions and coma have occurred when non-electrolyte solutions are used and have been the major problems. Both have resulted in fatalities. Nonetheless, complication rates have been acceptable. In the U.K. Mistletoe study (15) there was a 1.26% rate of emergency surgery (half laparoscopy only). There were two deaths in 10,880 women related to ablation. The complication rate was inversely proportional to the number of cases performed by the surgeon emphasizing the technical skills needed for hysteroscopic ablation. There was about an 85% satisfaction rate, and a low complication and death rate with a less costly procedure.
However favorable, the data accumulated on hysteroscopic endometrial ablation has not been followed by general acceptance of ablation as an alternative for hysterectomy.
O'Connor published (16) a randomized prospective trial comparing hysterectomy with hysteroscopic endometrial ablation. In a group of women with menorrhagia 56 were randomized to hysterectomy and 116 to hysteroscopic ablation. The uterus was 12 weeks or smaller, any submucus myoma 5 cm or less, and uterine supports were good. The staff were all experienced in both techniques. Statistical profiles of demographics, menstrual experience and uterine size were equivalent in both groups. The results showed general anesthesia in all hysterectomies compared to 86% in the ablation group. Operating time for ablation was half the time for hysterectomy. Hemorrhage occurred in 9% of the hysterectomy patients requiring transfusion in all but one. There was no hemorrhage in the ablation group but one patient required a pre-op-transfusion. There was a 3% fluid overload rate and one ablation could not be performed. The post-op stay averaged 6.3 days for hysterectomy versus 1.3 days for ablation and return to work was 2.9 weeks against 7.4 weeks for hysterectomy.
In spite of this comparative data and general experience, Bridgeman reported (17) in 2000 that the hysterectomy rate in the U.K. had not changed and there is a stable rate of endometrial ablation. The traditional use of hysterectomy prevails and there is a 25% increase in hysterectomy plus ablation procedures which can only come from women who refused hysterectomy and accepted ablation, women who could not be scheduled for hysterectomy in the Health system, or women who switched from hormonal therapy to ablation. In addition, it appears that only a small segment of gynecologists has become sufficiently interested to acquire the skills and equipment to perform hysteroscopic ablationIn order to reduce the skill level needed to perform ablation, improve safety, and lower cost, a second generation ablation device and technique was developed (18), Thermochoice is a balloon catheter which is inserted into the endometrial cavity, filled with 5% dextrose in water to 160 mm Hg. Pressure, and heated to 187 F for 8 minutes. In a prospective randomized trial against roller ball hysteroscopic ablation it produced comparable results and was approved by the F.D.A. Safety has been very high with no known deaths and two visceral injuries in over 100,000 cases in three years. Other second generation devices have come to the market and show effectiveness. The safety record for these devices is not available as they have only recently been released. At this point, ablation technology is becoming less expensive, more user friendly, requires less anesthesia and analgesia, and is producing about 85% patient satisfaction.
Hysterectomy remains a skill-dependent procedure with 100% effectiveness. However, its safety record for death and injury compares unfavorably with ablation. Its costs are higher and recovery is longer. The long term problems w?th ablation are failure before menopause requiring a repeat procedure, and the unknown rate of post ablation endometrial cancer. The long term impact of hysterectomy relate to psychosexual effects, bowel obstruction, and pelvic door weakness requiring surgical repair. While the data indicate that ablation has been slow to be practiced, the method is evolving with new technology to appeal to patients who fail, cannot use or refuse hormonal therapy and wish to avoid the costs, risks and the immediate and long term morbidity associated with hysterectomy. This information and the options are becoming more clear. Patient counseling must now include the full range of drug and procedure choices. Hysterectomy will certainly not disappear as a treatment for benign uterine diseases but its role in the treatment of peri-menopausal menorrhagia will undoubtedly assume a third line behind drugs and ablative therapy in those patients without contraindications to the f?rst and second line options.
References:
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