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Hysteroscopic Myomectomy 157
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28F, and the loop electrode comes with different angles. The tele­scopes also come with angles from 0
to 30◦. Most surgeons are limited to whatever their operating room has available to them; however, if there is a choice, the surgeon should try different sizes to determine the one with which he or she is most com­fortable. With the current use of saline-infused ultrasound and MRI, in most cases, the surgeon can be fairly certain that he or she is dealing with a submucosal myoma. In these cases, it is best to go directly into the cavity with the resectoscope and not use the diagnostic scope first. The main reason is that there is only so much fluid that the patient can absorb before the case must be stopped. It is useless to waste this time on an initial sur­vey with the diagnostic hysteroscope. The extremely rare risk of cervical damage is far outweighed by the increased risk of fluid overload.
The next important step is cervical dilatation. It is important to not overdilate the cervix as this may lead to the loss of disten­tion fluid aroundthe resectoscopeand difficulty indistending the cavity to appropriately see the myoma. This may be a problem in the case of a prolapsing myoma, in which the cervix is already significantly dilated before starting the procedure. In a case in which the cervix has been overdilated either by surgical error or by a prolapsing myoma, the surgeon can try to occlude the cervix by placing towel clamps either unilaterally or bilaterally on the cervix. Anotheroption that is typically more successful in achiev­ing the appropriateocclusionbuttakesmoretime involvesplacing a cerclage-like stitch around the cervix that can be tied around the resectoscope. The stitch can thenbe removed atthe end of the procedure. It is also important not to underdilate the cervix as larger myomas often require forward-and-backmovement of the entire resectoscope. This movement may be limited if the cervix is not sufficiently dilated, leading to possible complications.
The typical procedure is performed with a 12
loop. The resectoscope is designed so that the electrode
a90
telescope and
has a spring that brings it back to the sheath, which is insulated at the end to protect the patient from inadvertent bleeding. The electrode should be maximally extended to give the best visual­ization of the pathology during resection. The movement of the electrode during resection should always be toward the opera­tor. Movement away from the operator is more likely to result in uterine perforation and potential serious injury to the patient. There likely will be times when the loop is not visible as it should be on the far side of the myoma to resect it toward the operator; however, energy should be used only as the electrode is moved toward the operator. For larger myomas, the entire resectoscope must occasionally be moved with the electrode to shave off the entire length.
While shaving the myoma, difficulties often occur with the pieces. Occasionally, they get trapped between the electrode and the lens. This can usually be corrected by separating the electrode from thelens and making sure the flowof thedistention medium is working. A piece of the myoma may also become attached to the electrode. Surgeons often struggle in vain to remove these pieces. If the surgeon simply continues the procedure, the piece will typically come off with the next cut. Occasionally, the sur­geon may find it difficult to cut through the myoma with the electrode. This is typically because the power is set at too low a wattage or the surgeon is using a coagulation current instead of a cutting current. A cutting current wattage of 80 to 100 W is typically adequate for smoothly slicing the myoma. The current
works better by arcing it toward the tissue, so it is best to start the current just before the electrode actually makes contact with the tissue and to continue the movement smoothly. Moving too slowly may result in a coagulation of the tissue and a sticking of the electrode. Moving too quickly may lodge the electrode into tissue thathas not yetbeen cut. Usingthe coagulation currentat a setting between 30 and 40 W is appropriate for stoppingbleeding from any significant vessels from the myoma. It is not useful for shaving the myoma as the peak voltage that is required makes this more dangerous to peripheral tissue both in and outside the uterus. Also, the intermittent current makes the cells less likely to desiccate and therefore cut the tissue, and more likely to char the tissue.
Bubbles may occur during cutting, as a result either of gas forming during the cutting itself or of air in the inflow tubing. These can be visually distracting to the operator. It is important to maintaina good seal throughout the circuit of distention fluid. When bubbles form in the cavity, placing the end of the resecto­scope directly into the bubble and making sure that the outflow is turned on will usually eliminate the problem.
With regard to removing the myoma, there is debate as to how aggressive the surgeon should be. Many surgeons believe that for maximal safety, an operator should not resect below the endometrial surface. One would automatically believe that this may leave a significantpart of themyomabehind. However, when the myoma is shaved from the cavity, surgeons will find that the normal contractile nature of the uterus tends to force the intramural portion of the myoma into the cavity. It is frequently possible to remove the entire myoma in this fashion without actually having to dissect below the endometrial surface. For this technique to be successful, it is necessary to have at least 40% to 50% of the myoma protruding into the cavity when starting the procedure.
Some surgeons insist that it is prudent to remove the entire myoma regardless of the depth in which it is situated in the myometrium. Although itis true thatthe procedure is more likely to achieve long-term success when the entire myoma is removed, the risks of perforation and subsequent injury to bowel or vascu­lar structuresincrease significantly as one dissects deeper intothe myometrium. Ultrasound guidance occasionally has been used to determine depth and distance from the serosa, but it does not eliminate the potential risks. Indman[20]proposedinjecting car­boprost, a methyl analogue of prostaglandin F
, into the cervix.
2α
He reported ona series of13 patients witha significant amountof the submucosal myoma intramural. He found that thecarboprost caused uterine contraction, allowing 11 of the 13 myomas to be completely excised. No randomized study has been performed, and as this frequently happens without any injection,it isunclear whether carboprost truly makes any difference. As a general rule, a surgeon should proceed with extreme caution when dissecting below the endometrium.
Although it is a relatively safe procedure compared with abdominal myomectomy, hysteroscopicmyomectomyhas poten­tial risks as well. The risks of fluid overload and hyponatremia are discussed earlier in this section. The risk of uterine perfora­tion is higher in resectoscope cases. The cervix must be dilated to a greater amount to accommodate the large instrument, which may lead to perforation during dilatation. This is usually rec­ognized once the scope is place, either because it goes directly into the abdominal cavity or because there is an immediate fluid
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Table 8.3.1: Hysteroscopic Myomectomy for Abnormal Uterine Bleeding
Study Cases, no. Follow-up, %
Polena et al. [21] 235 84 40 94.4
Wamsteker et al. [22] 51 93.3 20 93.3
Emanuel et al. [23] 285 94 46 85.5
Cravello et al. [24] 196 86.2 73 82.2
Marziani et al. [25] 84 97 36 80.9
Kuzel et al. [26] 45 100 48 100
Hart et al. [27] 194 100 27 79
Munoz et al. [28] 120 100 36 88.5
Brooks et al. [29] 90 100 6 91
Derman et al. [30] 177 100 108 83.9
imbalance. If the perforation occurs before the use of the elec­trode, the procedure must be stopped; however, the patient usu­ally may simply be monitored in the recovery room for signs of intra-abdominal bleeding. Stable serial hemoglobin levels are reassuring, and the patient can be sent home and the procedure reattempted another day.
If the perforation occurs with the resectoscope while the elec­trode is charged, the potential for serious injury exists.Thepatient must have a thorough evaluationofthe abdomen and pelvis,typi­cally via laparoscopy, todetermine thepresence and extent of any injury. Unfortunately, thermal injuries to the intestine are not always readily apparent. If the bowel has been burned but not incised, the defect may only become apparent after a few days. Patients discharged home after this type of complication should be advised to monitor theirtemperature and report any gastroin­testinal symptoms, specifically nausea and vomiting.
Another possible complication afterthis procedure,especially in patients with a desire for future fertility, is intrauterine adhe­sions. These are more likely if two opposing fibroids have been resected so that the surfaces are juxtaposed after the procedure is completed. Although this is rare, should it occur, the surgeon has the option of giving the patient supplemental estrogen imme­diately postoperatively, with the goal of rapidly developing the endometrium to prevent adhesions. Another method attempted in the past was the placement of an intrauterine Foley catheter to keep the opposing surfaces away from one another until estrogen formed spontaneously.
The immediate postoperative care of patients having under­gone hysteroscopic myomectomy is generally not complicated. If an imbalance of fluid was noted during the procedure, the recov­ery room nurse should monitor the patient for signs and symp­toms offluid overload and hyponatremia, including bradycardia, hypertension, nausea,vomiting,seizures, pulmonary edema, and cardiac abnormalities. The management of these problems has been previously discussed. There is typically not much pain after this procedure. At our institution, we find that ketorolac 30 mg given IV soluset at the completion of the procedure is usually adequate anesthesia; our patients are not sent home with nar­cotics but are told to use an anti-inflammatory medication such
Average Follow-up
Time, months
Success (No Further
Surgery), %
as ibuprofen. The need for more significant pain control can be an indication of a more serious injury during the surgery and should be evaluated appropriately.
Patients should be told to expect per vaginal bleeding for approximately 1 week after the surgery. The duration of bleeding may vary from a few days to 2 weeks, but the flow usually is very light. Patients should also be warned that their cycle may be abnormal for the next month or two and a heavy menses following the procedure is not indicative of what their usual menses will be like once they return to a regular cycle.
LONG-TERM RESULTS: MENORRHAGIA AND FERTILITY
Most studies evaluating the results of hysteroscopic myomec­tomies specifically focus on subsequent fertility and menorrha­gia. The only true cure for uterine myomas is a total hysterec­tomy. Even women undergoing a supracervical hysterectomy for myomas should be advised that there is a very small risk of devel­oping a cervical myoma in the future. It is therefore inherent in the hysteroscopic myomectomy procedure that a success rate of 100% should not be expected. Some surgeons argue that the immediate, postoperative results should be close to 100% of the time. However, many women have anatomically normal uteruses with menorrhagia, dysfunctional uterine bleeding. It is impos­sible to know whether a woman with a submucosal myoma is bleeding irregularly solely because of the myoma or because of some other undetectable problem in her uterus. Only by remov­ing the myoma would this be found; however, its presence would be considered asurgical failure, even thoughthe goal ofremoving the myoma may have been completely successful. We know from data on abdominalmyomectomiesthat up to 30%of women who undergo the procedure will require an intervention for myomas in the future. There is no reason to believe that this should not be the case for patients with submucosal myomas as well.
Studies now exist looking at the 1- to 9-year follow-up of hysteroscopic myomectomies. Table 8.3.1 exhibits the results for patients treated specifically forabnormal bleeding. Hysteroscopic
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Table 8.3.2: Fertility Rates after Hysteroscopic Myomectomy
Study Patients, no. Follow-up Period, months % Followed % with Pregnancies
Ubaldi et al. [31] 134 NA NA 58.9
Goldenberg et al. [32] 15 12 100 47
Shokeir [33] 29 24 100 72.4
Bernard et al. [34] 31 24 100 35.5
Giatras et al. [35] 41 24 100 60.9
myomectomy has at least an 80% success rate for up to 9 years after surgery. Although it may seem that a failure rate of 20% is significantly high for any procedure, it is important to remem­ber that the alternative would have been for the patients to have undergone ahysterectomy, withits associated increasein compli­cations, pain, and lost productive time. In these studies, approx­imately half the patients who failed the procedure required a hysterectomy subsequently and the others had other forms of intervention, usually another hysteroscopy. At least 90% of these patients were able to avoid a hysterectomy by undergoing a min­imally invasive outpatient procedure that has considerably fewer risks.
Infertility isanother common reason for undergoinghystero­scopicmyomectomy.Again, infertility ismultifactorial,andmany patients who are infertile will not be found to have any apparent problems. It is very possible that a woman may have infertil­ity from an unknown source and have a submucosal myoma as well, so fertility rates after resection of myomas should be evalu­ated with this information in mind. Table 8.3.2 reports the find­ings from a number of studies designed to evaluate fertility after hysteroscopic myomectomy. Pregnancy rates vary from 35% to 70%, representing a dramatic increase in fertility after hystero­scopic myomectomy in patients having infertility and a submu­cous myoma. Given that these women typically would have had limited options–amyomectomy,withitsassociated morbidity, or a hysterectomy, which clearly eliminates any chance of fertil­ity in the future – hysteroscopic myomectomy represents a great advancement.
NEW TECHNIQUES
Surgeons are always trying to improve on current techniques in an attempt to decrease operative risks and improve outcomes. The development of the hysteroscopic myomectomy is an exam­ple of this, and within the context of the hysteroscopic myomec­tomy, advances continue. Because of thefluidbalance risks, better fluid management systems have emerged over the last few years that greatly enhance the surgeon’s ability to closely monitor the fluid balance to significantly decrease the risk of the patient ever developing hyponatremia or general fluid overload. The most advanced system would monitor input and output, maintain a hysteroscopic intrauterine pressure sufficient to distend the cav­ity but not excessive, present all these data on the video screen used for theprocedure,and have alarms to alertthe surgeon when any parameters reached levels of increased risk. Surgeons would have to consciously choose to ignore the warnings to cause harm. As with any device, there is always the risk of instrument error,
so the surgeon should not have a complete sense of security with this instrumentation. Having the equipment decreases the risks but does not excuse the surgeon from monitoring all aspects of the surgery closely so as to catch equipment errors if they arise. Although there is no correction for poor surgical technique or judgment on the part of the surgeon, new devices limit the risk as much as possible.
Because a monopolar electric current is somewhat uncon­trolled once it leaves the electrode, many surgeonsbelieve a bipo­lar device is safer. With the standard monopolar electrode, the current has its greatest effect within millimeters from the elec­trode. It is then dispersed in all directions and is reaccumulated at the grounding pad and returned to the generator. The dis­persed current is usually too weak to cause harm. The current will flow in a path of least resistance. In the setting of a hystero­scopic myomectomy, the myoma and the tissue surrounding it generally have a uniform resistance, so the current flows in all directions. If there is aberrant anatomy, it is possible that a chan­nel of less resistance might exist, concentrating the current and potentially harming the patient. This is the reason the grounding pads are wide: if they were attached at a single point, the entire current would accumulate at that point and cause injury.
Bipolar instruments have opposing electrodes that are posi­tive and negative, so thecurrentflows only between theelectrodes and isnotdispersedthroughoutthepatient.Thismore-controlled current should be safer as it is not dispersed through the patient. The VersaPoint system by Gynecare is an example of a system with this design. Clark et al. [36] performed a feasibility study on this technique, which they reported in 2002. Using the bipolar device, they operated on 37 women with a submucous myoma. They found that 92% of the patients were satisfied with the pro­cedure, although only 78% reported improvement in bleeding. There were no operative complications, and the authors con­sidered this technique to be an improvement over the standard monopolar technique.
In addition to the increased safety of the better-controlled current, bipolar techniques offer other advantages. Using a bipo­lar electrode allows the surgeon to use normal saline as the dis­tending fluid. Although this does not eliminate the risks of fluid overload, it greatly decreases the risk of hyponatremia. This does not eliminate the need for close fluid monitoring, as at least one death has occurred as a result of fluid overload using this sys­tem. However, it increases the amount of fluid that may be safely absorbed to 2000 to 2500 mL, which may give the surgeon valu­able additional time to perform the procedure completely.
The bipolar technique also has improved with regard to the tissue affected by the current. In most cases, as the elec­trode is moved through the myoma, it completely vaporizes the
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tissue. This eliminates or greatly decreases the amount of float­ing pieces of myoma that obscure the operative field, which may both lengthen the procedure and increase operative errors due to the obstructed view. One negative would be that the tissue is not evaluated by a pathologist to assure that the treated lesion is indeed a simple myoma and not a more serious condition, such as a sarcoma. This is very rare, however, and may not outweigh the benefits offered by this technique.
Another new technique eliminates the risk of electrosurgery. The Smith & Nephew operative hysteroscopy system involves a rotatingmorcellatingblade.Theopening isonthe sideofthedistal end of the hysteroscope. This opening is placed on the myoma, and the rotating blade shaves the myoma. The cutting is all sharp as no electric current is used. The shaved pieces are immediately suctioned out of the uterus through the scope and collected for pathologic review. This technique uses the normal contraction of the uterus that occurs during a hysteroscopic myomectomy to both force the myoma out of the myometrium and contract the vessels surrounding the myoma to decrease bleeding. This technique limits the surgeon’s ability to dissect deeper into the uterine wall to remove the entire myoma if it is not expelled by uterine contraction, a limitation that is probably safer for the patient. The procedure, like the bipolar technique, may be performed with normal saline, with the same decreased risk of hyponatremia. Surgeons shouldhavesome type of electrosurgery device available to manage bleeding should it occur.
The opportunity to improve patient care drives those in the medical field toconstantly search for newdevices and techniques. With the adoption of the resectoscope, gynecologists have been able to save countless women from experiencing excessive pain, lost productive time, and unnecessary major surgery. Although risks exist in everything we do as surgeons, the resectoscope greatly reduces those involved in surgeries for uterine myomas. Advances continue to reducethese risks and make the options for treatment of uterine myoma safer for women suffering from the effects of this condition.
REFERENCES
1. Neuwirth RS, AminHK. Excision ofsubmucous fibroids with hys­teroscopic control. Am J Obstet Gynecol. 1976;126:95–99.
2. Nesbit RM. A history of transurethral prostatic resection. In: Sil­ber SJ, ed. Transurethral Resection. New York: Appleton-Century- Crofts; 1977:1–17.
3. Stern M. Resection of obstruction at the vesical orifice. JAMA. 1926;87:1726–1730.
4. d’Arsonval A. Action physiologique dex courants alternatifs a grand frequence. Arch Physiol Norm Pathol. 1893;5:401–408.
5. Goldwyn RM. Bovie: the man and the machine. Ann Plast Surg . 1979;2(2):135–153.
6. McCarthy JF. The management of prostatic obstruction by endo­scopic revision. NEnglJMed. 1932;207(7):305–312.
7. Iglesias JJ, SporerA, Gellman AC, SeebodeJJ.New Iglesias resecto­scope with continuous irrigation, simultaneous suction, and low intravesicle pressure. JUrol. 1975;114:929–933.
8. Baggish MS, Brill AI, Rosensweig B, Barbot JE, Indman P. Fatal acute glycine and sorbitol toxicity during operative hysteroscopy. J Gynecol Surg. 1993;9:137–143.
9. Loffer FD. Complications from uterine distention during hys­teroscopy. In: Corfman KS, Diamond MP, DeCherney A, eds.
Complications in Laparoscopy and Hysteroscopy. Boston: Blackwell Scientific Publications; 1993:117–186.
10. Cepni I, Ocal P, Erkan S, et al. Comparison of transvaginal sonog­raphy, saline infusion sonography and hysteroscopy in the evalua­tion of the uterine cavity pathologies. AustNZJObstetGynaecol. 2005;45(1):30–35.
11. de Vries LD, Dijkhuizen FP, Mol BW, Brolmann HA, Moret E, Heintz AP. Comparison of transvaginal sonography, saline infu­sion sonography, and hysteroscopy in premenopausal women with abnormal uterine bleeding. J Clin Ultrasound. 2000;28(5): 217–223.
12. Salim R, Lee C, Davies A, Jolaoso B, Ofuasia E, Jurkovic D. A comparison study of three-dimensional saline infusion sonohys­terography and diagnostic hysteroscopy for the classification of submucous fibroids. Hum Reprod . 2005;20:252–257.
13. Nilsson L,Rybo G.Treatmentofmenorrhagia.AmJ ObstetGynecol. 1971;110:713–720.
14. Brooks PG, Serden SP. Preparation of the endometrium for abla­tion with a single dose of leuprolide acetate depot. JReprodMed. 1991;36:477–478.
15. Friedman AJ, Hoffman DI, Comite F, Browneller RW, Miller JD. Treatment of leiomyomata uteri with leuprolide acetate depot – a double blind, placebo controlled multicenter study. Obstet Gynecol. 1991;77:720–725.
16. Coddington CC, Brzyski R, Hansen KA, Corley DR, McIntyre­Seltman K,JonesHW.Shortterm treatmentwithleuprolide acetate is a successful adjunct to surgical therapy of leiomyomas of the uterus. Surg Gynecol Obstet. 1992;175:57–63.
17. Perino A, ChianchianoN, PetronioM, Cittadini E. Role of leupro­lide acetatedepotinhysteroscopic surgery: a controlledstudy.Fertil Steril. 1993;59:507–510.
18. Gimpelson RJ, Kaigh J. Mechanical preparation of the endometrium prior to endometrial ablation. JReprodMed. 1992;37:691–694.
19. Lefler HT, Sullivan GH, Hulka JF. Modified endometrial ablation electrocoagulation with vasopressin and suction curettage prepa­ration. Obstet Gynecol. 1991;77:949–953.
20. Indman P. Useof carboprost tofacilitate hysteroscopicresection of submucous myomas.J AmAssoc Gynecol Laparosc. 2004, 11(1):68–
72.
21. Polena V, Mergui JL, Perrot N, Poncelet C, Barranger E, Uzan S. Long-term results of hysteroscopic myomectomy in 235 patents. Eur J Obstet Gynecol Reprod Biol. 2007/Feb;130(2): 272–7.
22. Wamsteker K, Emanuel MH, de Kruif JH. Transcervical hys­teroscopic resection of submucous fibroids for abnormal uter­ine bleeding: results regarding the degree of intramural extension. Obstet Gynecol. 1993;82(5):736–740.
23. Emanuel MH, Wamsteker K, Hart AA, Metz R, Lammes FB. Long term results of hysteroscopic myomectomy for abnormal uterine bleeding. Obstet Gynecol. 1999;93(5 pt 1):743–748.
24. Cravello L,Farnarier J,RogerV,D’Ercole C, Blanc B.Hysteroscopic myomectomy. Functional results with an average follow-up of 6 years. J Gynecol Obstet Biol Reprod. 1998;27(6):593–597.
25. Marziani R, Mossa B, Ebano V, Perniola G, Mellusa J, Napoli­tano C. Transcervical hysteroscopic myomectomy: long term effects on abnormal uterine bleeding. Clin Exp Obstet Gynecol. 2005;32(1):23–26.
26. Kuzel D, Toth D, Fucikova Z, Cibula D, Hruskova H, Zivny. Hys­teroscopic resection of submucosal myomas in abnormal uter­ine bleeding: results of a 4-year prospective study. Ceska Gynecol. 1999;64(6):363–367.
27. Hart R,MolnarBG,MagosA.Longtermfollowup ofhysteroscopic myomectomy assessed by survival analysis. Br J Obstet Gynaecol. 1999;106(7):700–705.
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28. Munoz JL, Jimenez JS, Hernandez C, et al. Hysteroscopic myomectomy: our experience and review. JSLS. 2003;7(1):39–48.
29. Brooks PG, Loffer FD, Serden SP. Resectoscopic removal of symp­tomatic intrauterine lesions. JReprodMed. 1989;34(7):435–437.
30. Derman SG, Rehnstrom J, Neuwirth RS. The long-term effective­ness of hysteroscopic treatment of menorrhagia and leiomyomas. Obstet Gynecol. 1991;77(4):591–594.
31. Ubaldi F, Tournaye H, Camus M, Van der Pas H, Gepts E, Devroey P. Fertility after hysteroscopic myomectomy. Hum Reprod Update. 1995;1(1):81–90.
32. Goldenberg M, Sivan E, Sharabi Z, Bider D, Rabinovici J, Seidman DS. Outcome of hysteroscopic resection of submucous myomas for infertility. Fertil Steril. 1995;64(4):714–716.
33. Shokeir TA. Hysteroscopic management of submucous fibroids to improve fertility. Arch Gynecol Obstet. 2005;273(1):50–54.
34. Bernard G, Darai E, Poncelet C, Benifla JL, Madelenat P. Fertility after hysteroscopic myomectomy: effect of intramural myomas associated. Eur J Obstet Gynecol Reprod Biol. 2000;88(1): 85–90.
35. Giatras K, Berkeley AS, Noyes N, Licciardi F, Lolis D, Grifo JA. Fertility after hysteroscopic resection of submucous myomas. J Am Assoc Gynecol Laparosc. 1999;6(2):155–158.
36. Clark TJ,MahajanD,SunderP,Gupta JK. Hysteroscopictreatment of symptomatic submucous fibroids using a bipolar intrauter­ine system: a feasibility study. Eur J Obstet Gynecol Reprod Biol. 2002;100(2):237–242.
Section 8.4. Hysteroscopic Tubal Cannulation
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Tommaso Falcone and Jeffrey M. Goldberg
The concept of cannulating the intramural portion of the tube to relieve an obstruction in infertile patients has been around since the 19th century. Tubal cannulation is also performed for diagnostic assessment,transfer of gametes or embryos, andsteril­ization. The radiologic and hysteroscopic approaches to relieving obstruction were investigated in the mid-1980s and remain an integral part of infertility treatment.
DIAGNOSIS OF PROXIMAL TUBAL BLOCK
Approximately 25% to 30% of infertility in women is the result of tubal disease, with proximal tubal occlusion (PTO) account­ing for the infertility in 10% to 25% of those patients.[1] Hys­terosalpingogram (HSG) is the first-line technique for excluding anatomic defects in the uterine cavity and documenting tubal patency in infertility patients. It is part of the basic infertility work-up and is normally required in every patient.[2] PTO is found on 10% to 20% of hysterosalpingograms [1] and may be caused by obstruction due to tubal spasm or plugging by mucus and amorphous material or by occlusion from fibrosis or endometriosis. Infectious causes include salpingitis isthmica nodosa (SIN), pelvic inflammatory disease (PID), and tubercu­losis. These infections maydamage otherareas of the tube,which will affect the prognosis of the treatment.
HSG is considered the standard test for assessment of the uterine tubes in patients with infertility. If HSG suggests patent tubes, tubal blockage is highly unlikely.[3] One study noted that 60% of patients with PTO on HSG were patent on repeat HSG 1 month later.[4] Similarly, tubal blockage on HSG is not con­firmed by laparoscopy in up to 62% of patients.[3] It should be noted that laparoscopy is not the perfect gold standard as 2% of patients with bilateral tubal occlusion subsequently conceived spontaneously.[5] Also, Sulak et al. [6] reported that 11 of 18 patients with bilateral PTO on both HSG and laparoscopy were patent histologically.
Diagnostic laparoscopy and hysteroscopy to assess the uterus and tubes are probably more cost-effective than HSG in patients with pelvic pain, adnexal masses, or other indications for surgery as well as a history of PID or prior pelvic surgery. These patients are much more likely to have pelvic pathology requiring surgical treatment, regardless of the results of HSG.
MANAGEMENT OF PROXIMAL TUBAL BLOCKAGE
Historically, PTO was managed by coring out the uterine cor­nua and implanting the proximal fallopian tube within the
endometrial cavity. The procedure was abandoned because of low pregnancy rates and increasedriskfor cornual rupture during pregnancy.Itwasreplaced with microsurgical resectionandanas­tomosis in the late 1970s. Transcervical tubal cannulation by flu­oroscopic guidance was first reported in 1985 [7]; hysteroscopic tubal cannulation was reported 2 years later.[8]
As noted above, 60% of patients with PTO on HSG were shown to be patent on repeat HSG 1 month later.[4] Therefore, selective salpingography may be attempted if a repeat HSG at least 1 month later confirms persistent PTO. The repeat HSG is performed underintravenous conscious sedationusing a balloon catheter with a5F catheter advanced through it andwedged in the cornua under fluoroscopic guidance. Contrast is then injected, establishing patency in a third of the tubes.[9]
Tubal cannulation may be attempted in the two thirds of tubes that remained occluded during selective salpingography. A flexible guidewire is then passed through the tubal ostium and, if successful, a 3F catheter is advanced over the wire and contrast is injected (Figure 8.4.1). In one study, the procedure successfully established patency in more than 85% of cases.[1] After relieving the obstruction, distal tubal disease may be found (Figure 8.4.2).
Excision of the proximal tubes in cases of failed tubal can­nulation revealed SIN, chronic salpingitis, or fibrosis in 93% of patients in one study.[10] About a third of the opened tubes reocclude.[1,9] Tubal perforation has been reported in 3% to 11% of cases but has always been innocuous.[11]
Laparoscopy with transcervical chromotubation with dilute indigo carmine should beperformedtoconfirmPTOininfertility patients whohave not had a diagnostic laparoscopy or in patients with known pelvic disease. Hysteroscopic cannulation may be attempted at that time if persistent PTO is noted. Success rates in terms of patency,reocclusion,andperforation are nearly identical tothoseforradiologic cannulation,butpregnancyratesarehigher with the hysteroscopic approach.
Ongoing pregnancy rates following hysteroscopic tubal can­nulation were similar to those for microsurgical resection and anastomosis of PTO: almost 50%. In this study report that ana­lyzed several studies,theradiologic group wasdividedinto “high­success” and “low-success.” [1] However, the ongoing pregnancy rate after fluoroscopic canalization was significantly lower in the high-success group: 29%. The overall pregnancy rate in the low­success group wasonly 12.2%, with inadequate data to determine pregnancy outcomes. Unfortunately, there was no way to distin­guish between thesegroups from the studies(Table 8.4.1).[1] The higher pregnancy rate with the hysteroscopic approach is likely the resultof the fact that other pelvic pathology can bediagnosed and treatedlaparoscopically, whereas concurrent pelvic disease is unrecognized with fluoroscopic tubal cannulation.
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Hysteroscopic Tubal Cannulation 163
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Table 8.4.1: Pregnancy Rates Following Treatment of Proximal Tubal Blockage
Figure 8.4.1. Fluoroscopic tubal cannulation. The arrow indicates the end of the outer catheter in the cornua, and the arrowhead is the tip of the inner catheter within the proximal tube.
TECHNIQUE
The contraindications tohysteroscopic tubal cannulation include active infection, heavyuterine bleeding, potential pregnancy,and uterine malignancy. Patients with known allergy or adverse reac­tion to contrast dye used to establish patency should be appro­priately counseled. The potential complications associated with the procedure are listed in Table 8.4.2. Reversal of the occlusion in the cornua may improve fertility sufficiently to result in an ectopic pregnancy. The catheter or wire guide may dissect or per­forate the tubal wall. A dissection of the tubal wall may lead to extravasation of the contrast material or dye.
Figure 8.4.2. Appearance of the tube after successful cannulation of the tube shows distal tubal disease.
Patients, no./
Studies, no.
Microsurgery 175/5 83 (47.4) 7 (4) 13
Fluoroscopy
Hysteroscopy 133/4 22 (48.9) 3 (6.7) 2
SAB, spontaneous abortion. See Honore et al. for source data. [1]
20 weeks gestation.
High-success group.
163/4 47 (28.8) 11 (6.7) 4
Ongoing, no. (%)
SAB, no.
(%)
Ectopic, no. (%)
(7.4)
(2.4)
(4.4)
Table 8.4.2: Adverse Effects of Hysteroscopic Tubal Cannulation
Damage to normal tube
Dissection
Perforation
Pain
Ectopic pregnancy
The standard cannulation set usedistheNovycornualcannu­lation set. The tubal cannulation techniquewasdescribedbyNovy and colleagues.[12] The procedureis carried out using astandard 5-mm hysteroscope with anoperativechannel. The procedure for fluoroscopic cannulation is accomplished using the same prin­ciple. The set has two separate catheter systems. The first is a 5F catheter, called the introducing catheter, with two ports: one for the introduction of the obturator and the other for the introduc­tion of the second catheter, which is 3F.
Knowledge of the anatomy of the intramural portion of the tube is important to properly carry out the procedure. The intra­mural portion ofthe uterine tubes is typically 1 to 2 cm in length. Three patterns have been described.[13] The segment may be straight, curved, or tortuous. The course of the tube is not nec­essarily symmetrical in the patient, and each intramural por­tion may be different. The most frequent pattern is tortuous fol­lowed by straight and curved. The direction of the mucosal folds is toward the uterine tube. Introduction of the catheter should therefore follow this direction. There is a potential sphincter at this junction that is probably composed of the uterine smooth layers.Thiscan close the tube, as evidenced byspasmduringHSG.
Preoperatively, the patient may require something to facili­tate cervical dilatation, such as the (off-label) use of misoprostol or insertion of laminaria tents. A preoperative antibiotic, such as a cephalosporin, should be given. A laparoscopy is performed simultaneously,and a “picture-in-picture” view isbrought on the monitor so that the laparoscopic view of the fimbriated end of the tube and the hysteroscopic view of uterine cavity are simul­taneously visualized (Figure 8.4.3). If the patient is shown to have distal tubal disease as well, the procedure is terminated.
164 Tommaso Falcone and Jeffrey M. Goldberg
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Figure 8.4.3. The outer catheter has been introduced through the hys­teroscope into the uterine cavity. The distal transparent end is curved and is brought up to the tubal ostia.
Uterine tubeswith proximal and distal disease should be referred for IVF. If the distal end of the tube is adequate, the next step is to inject dilute dye through a uterine manipulator to confirm the cornual obstruction. If confirmed, the hysteroscopic procedure can proceed.
The introducing catheter is inserted into the operating chan­nel of the hysteroscope. An angled lens is typically used. The obturator is then removed and the catheter occluded. The tip of this catheter is curved and wedged against the tubal ostium (Fig­ure 8.4.3). Dilute indigo carmine dye may be injected. If dye is seen coming from the tube, patency is confirmed and the pro­cedure is finished. If no dye is seen, the inner catheter will be introduced to cannulate the tube.
The inner catheter has 1-cm markings. Theguidewireisintro­duced through this catheter,whichhas a special adaptor for secur­ing the wire. The wire is positioned at the tip of this catheter
Figure 8.4.4. The inner catheter with markings is seen through the distal transparent sheath.
and the adaptor tightened. The catheter and wire are introduced through the side of the introducing catheter up to the tip. Both catheters and the guidewire should be flush. The cannulation of the tube occurs first with the guidewire, and then the inner catheter is brought over it. The guidewire is advanced slowly through the uterotubal junction into the intramural portion of the tube into the isthmic portion (Figure 8.4.4). This can be seen by laparoscopy. Thecatheter is thenadvanced over the guidewire. The distanceintothetubecanbemeasuredbythemarkingsonthe catheter. The guidewire is removed and the dilute dye is injected under laparoscopic observation. If dye isobserved, theprocedure is terminated. If there is resistance to passage of the guidewire or catheter, an attempt is made to mobilize the tube laparoscopi­cally. If unsuccessful, the procedure is terminated. If the cause of the obstruction is not apparent, the next step is to counsel the patient regarding tubal surgery or IVF.
REFERENCES
1. Honore GM, Holden AE, Schenken RS. Pathophysiology and management of proximal tubal blockage. Fertil Steril. 1999;71: 785–795.
2. Hedon B, Dechaud H, Boulot P, Laffargue F. Critical evaluation of the fallopian tube. In: Kempers RD, Cohen J, Haney AF, Younger BJ, eds. Fertility and Reproductive Medicine. Amsterdam: Elsevier Science; 1998:61–70.
3. Evers JL, LandJA,Mol BW. Evidence-based medicinefordiagnostic questions. SemReprodMed. 2003;21:9–15.
4. Dessole S, Meloni GB, Capobianco G, Manzoni MA, Ambrosini G, Canalis GC. A second hysterosalpingography reducesthe use of selective technique for treatment of a proximal tubal obstruction. Fertil Steril. 2000;73:1037–1039.
5. Mol BW, Collins JA, Burrows EA, Van DV, Bossuyt PM. Com­parison of hysterosalpingography and laparoscopy in predicting fertility outcome. Hum Reprod. 1999;14:1237–1242.
6. Sulak PJ, Letterie GS, Coddington CC, Hayslip CC, Woodward JE, Klein TA. Histology of proximal tubal occlusion. Fertil Steril. 1987;48:437–440.
7. Platia MP, Krudy AG. Transvaginal fluoroscopic recanaliza­tion of a proximally occluded oviduct. Fertil Steril. 1985;44: 704–706.
8. Sulak PJ, Letterie GS, Hayslip CC, Coddington CC,Klein TA. Hys­teroscopic cannulation and lavage in the treatment of proximal tubal occlusion. Fertil Steril. 1987;48:493–494.
9. Pinto AB, Hovsepian DM, Wattanakumtornkul S, Pilgram TK. Pregnancy outcomes after fallopian tube recanalization: oil-based versus water-soluble contrast agents. J Vasc Intervent Radiol. 2003;14:69–74.
10. Letterie GS, Sakas EL. Histology of proximal tubal obstruction in cases of unsuccessful tubal canalization. Fertil Steril. 1991;56:831–
835.
11. Dessole S, Farina M, Rubattu G, Cosmi E, Ambrosini G, Battista NG. Sideeffects and complications ofsonohysterosalpingography. Fertil Steril. 2003;80:620–624.
12. Novy MJ, Thurmond AS, Patton P, Uchida BT, Rosch J. Diagnosis of cornealobstruction by transcervical fallopiantube cannulation. Fertil Steril. 1988;50:434–440.
13. Rozewicki S, Radomska A, Kurzawa R. Relation between anatom­ical courses of the intramural portions of the uterine tubes and pelvic endometriosis. Fertil Steril. 2005;85:60–66.
Section 8.5. Hysteroscopic Sterilization
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Stephanie N. Morris and Keith Isaacson
Tubal sterilization is the most common form of birth control used by women in the United States.[1] About half of all tubal sterilizations are performed as interval procedures (unrelated to pregnancy), the vast majority (89%) of which are completed laparoscopically.[1,2] Although laparoscopictubal ligation issafe and effective, it requires general anesthesia and entry into the abdominal cavity, both of which are associated with rare but potentially serious complications.
Transcervical or hysteroscopic sterilization can offer patients an alternative option for permanent sterilization. Despite multi­ple efforts over the past 30 years, acceptable methods of transcer­vical permanent contraception have only recently been devel­oped. Previous strategies for hysteroscopic sterilization have included mechanical tubal occlusive devices or plugs, intratubal or intrauterine sclerosing agents, and destruction of a portion of the fallopian tube with thermal energy.[3] Until recently, these attempts have been unsuccessful because of unacceptably high rates of pregnancy,ectopic pregnancy,expulsionofdevices, infec­tion, and perforation.
New hysteroscopicsterilization techniques offer effective per­manent contraception without the discomfort, associated recov­ery time, and risks of a laparoscopic procedure with general anes­thesia. Furthermore, hysteroscopic sterilization is an alternative for women in whom laparoscopy is especially difficult or con­traindicated, such as women with severe cardiopulmonary dis­ease, a history of prior abdominal or pelvic surgery with known extensive adhesions, or obesity.
Currently, there is only one hysteroscopic sterilization device approved by the U. S. Food and Drug Administration (FDA): Essure (Conceptus, San Carlos, CA). The Essure device has proved to be a highly effective permanent birth control option, with a low rate of associated adverse outcomes and high patient acceptance.[1,4–6] There are several other technologies cur­rently undergoing initial clinical trials, including the Ovion sys­tem (American Medical Systems, Minnetonka, MN) and Adiana (Cytyc, Marlborough, MA).
ESSURE
Description and Mechanism of Action
The Essure system is the first hysteroscopic tubal sterilization device to be approved by the FDA, in 2002. Using a transvagi­nal approach, one micro-insert is placed in the proximal portion of each fallopian tube.[7] When the micro-insert is released, it expands and anchors itself in the fallopian tube. Over time, the micro-insert elicits a benign inflammatory response, which ulti­mately leads to tubal occlusion and permanent contraception.
As described in the package insert [7], the Essure micro­insert consists of a stainless steel inner coil and a nickel titanium (nitinol)-expanding outer coil. The inner coil attaches the device to the delivery wire that is used for placement of the device. The outercoilexpandsupondeploymentandanchorsthedeviceinthe fallopian tube. Polyethylene terephthalate (PET) fibers are wound in and aroundtheinnercoil.ThePETfibers,whichhavebeenused in other medical devices, produce an immediate local inflam­matory response characterized by macrophages, mononuclear cells, fibroblasts, foreign body giant cells, and plasma cells.[8,9] This inflammatory response peaks between 2 and 3 weeks and lasts approximately 10 weeks.[8,10] The resulting fibrosis causes occlusion of the fallopian tubesand results in permanent anchor­ing of the device and contraceptive effects.
During insertion, the micro-insert is maintained in the wound-down position through the use of a release catheter that is sheathed by a hydrophilic delivery catheter to help with tubal placement (Figure 8.5.1).[6] The outer coil expands from 4.0 cm in length and 0.8 mm in diameter in the wound-down position to 1.5 to 2.0 mm in diameter when released from the delivery wire, depending on the diameter and shape of the fallopian tube (Figure 8.5.2).[7]
Ideally, the micro-insert should span the uterotubal junction (UTJ), defined as the portion of the fallopian tube just as it exits the uterus (Figure 8.5.3). In this position, the springlike release of the device and expansion of the outer coil lead to anchoring during the acute phase of device implantation.[7] The PET fibers then elicit a chronic inflammatory and fibrotic response, leading to tissue ingrowth into the device and complete occlusion of the fallopian tube lumen, resulting in permanent retention of the micro-insert and the contraceptive effects.[9]
Clinical Use and Technique
There are several clinical considerations to keep in mind when performing an Essure placement. The Essure system is designed as an interval tubal sterilization technique. Therefore, the patient should be at least 6 weeks post delivery or termination.[7]
Ideally, the procedure should be timed with thepatient’s men­strual cycle. Insertion is recommended during the early prolifer­ative phase of the menstrual cycle to improve visualization of the fallopian tube ostia and prevent placement in a luteal phase pregnancy.[7] Alternatively, the patient can be pretreated with oral contraceptive pills or Depo Provera (Pfizer) to help thin the endometrial lining and avoid placement in an undiagnosed preg­nancy. As reported in a study by Kerin et al. [4], the time of the menstrual cycle during which the procedure was performed did not affect success rates of bilateral device placement. However, it
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Figure 8.5.1. Essure micro-insert in wound-down configuration. The Essure micro-insert, when attached to the delivery wire in a wound­down configuration, is 4 cm in length and 0.8 mm in diameter. Used with permission from Conceptus.
was easier to see the tubal opening before ovulation, when the endometrial lining was thinner.[4]
Several measures should be taken to avoid placement dur­ing an undiagnosed pregnancy and to prevent unplanned preg­nancy after insertion. First, apregnancy test shouldbe performed within 24 hours before the procedure. The combination of a pregnancy test and placement of the device during the first half of the cycle should help avoid an undetected luteal phase preg­nancy.Finally, the patient should be advised to usecontraception for 3 months after the procedure, until complete tubal occlu­sion and proper micro-insert placement can be verified by a hysterosalpingogram.[7]
Essure placement can be performed in the office or as outpa­tient surgery. The majority of these procedures can be performed with local anesthesia alone.[4,5,11] In a recent multicenter study of more than 100 women, 81% underwent the procedure with local paracervical block without additional intravenous sedation and tolerated the procedure well.[11] It is the decision of the patient and provider whether to use anesthesia, such as intra­venous conscious sedation, in addition to a paracervical block. If only a paracervical block is used, an oral anxiolytic may be administered to the patient before the procedure. Our preferred technique for paracervical block involves injecting a total of 20 mL of 1% lidocaine without epinephrine, with 10 mL each at the 4 and 8 o’clock positions.[12] After the paracervical block is per­formed, itis important to wait several minutes before starting the procedure to give enough time for the anesthetic to take effect.
Regardless of the anesthetic choice, a nonsteroidal anti­inflammatory drug (NSAID) should be given 30 to 60 minutes before the procedure. Not only does this provide additional pain relief, but administration of NSAIDs before the procedure also increases the chance of successful cannulation of the fallopian tube and placement of the micro-inserts.[5] It is thought that preprocedural NSAIDs decrease the chance of tubal spasm, thus increasing the rate of successful placement.
To perform the insertion of the micro-inserts, the patient is placed inthe semidorsal lithotomy position, using the examtable stirrups if the procedure is performed in the office. An open­sided speculum is placed in the vagina, the cervix is prepped with Betadine, and aparacervical block is performed. The micro­inserts are placed using the Essure delivery system through a small-caliber hysteroscope (usually 5-mm outer diameter) with
Figure 8.5.3. Diagram of the UTJ. The micro-insert should span the UTJ, defined as the portion of the fallopian tube just as it exits the uterus. In this location, the coils span the intramural and proximal isthmic portions of the fallopian tube. The device is placed far enough into the tube to prevent expulsion during uterine contractions during menses but still has a portion trailing into the uterine cavity. The outer diameter of the coils that trail into the uterus is larger than that of the coils in the fallopian tube, which helps anchor the device. The UTJ is most consistently the narrowest portion of the fallopian tube, which further aids in anchoring thedevice. Used with permission from Conceptus.
a continuous-flow system and an operating channel of at least 5F (1.7-mm internal diameter) (Figure 8.5.4). The hysteroscope is placed under direct visualization through the cervix and into the uterine cavity without prior cervical dilation. Normal saline is used during placement of the hysteroscope to aid in visualization as well as to gently dilate the cervical canal and uterus. An initial attempt to pass the hysteroscope may be made without the use of a tenaculum. If the hysteroscope is not passed easily, a tenaculum is placed to aid in the insertion, and if needed, cervical dilation may be performed.
Normal saline is used to distend the uterine cavity. Saline that is body temperature and introduced “under gravity” is rec­ommended tohelp minimize patient discomfort. To achieveade­quate distention, the saline bag must be approximately 120 to 140 cm above the uterus. Pressure bags may also be used to help maintain uterine distention if there is cervical leakage due to a patulous cervix.[7] Both tubal ostia should be visualized before placement of the device. A 12 to help with visualization of the ostia as well as with cannulation of the fallopian tube (Figure 8.5.5). The 12
or 30◦hysteroscope may be used
scope is helpful in
cases of more-forward tubal ostia and in placement of the device,
Figure 8.5.2. Expanded Essure device. The Essure micro-insert expands to a diameter of 1.5 to 2 mm, depending on the diameter and shape of the surrounding fallopian tube. Used with permission from Conceptus.
Figure 8.5.4. The Essuredelivery systemand hysteroscopicequipment. The Essure delivery system with the micro-insert attached to the deliv­ery catheter. Used with permission from Conceptus.