7
Laparoscopic occlusion of uterine vessels for the treatment of symptomatic fibroids: Initial experience and comparison to uterine artery embolization Kirsten Hald, MD, a Anton Langebrekke, MD, a Nils Einar Kløw, MD, PhD, b Hans Jørgen Noreng, MD, b Anette Bugge Berge, MD, b Olav Istre, MD, PhD a, * Departments of Obstetrics and Gynecology a and Radiology, b Ullevaal Hospital, University of Oslo, Oslo, Norway Received March 27, 2003; revised June 9, 2003; accepted June 26, 2003 Objective: Our purpose was to evaluate the effects of laparoscopic occlusion of uterine vessels in treating symptomatic fibroids and compare with embolization of the uterine arteries. Study design: We studied 46 premenopausal women, aged 43 (34-51) years with symptomatic uterine fibroids, undergoing radiologic embolization (n = 24) and laparoscopy closure of the uterine arteries (n = 22). Results: The laparascopic technique reduced picture blood assessment score after 6 months by 50% from an initial value of 345 (G288). Uterus volume was reduced by 37% (G18%), and the dominant fibroid was reduced by 36% (G31%). Postoperative pain and use of pain relief dif- fered significantly, requiring more pain medication after embolization: ketobemidon 38 mg com- pared with 16 mg in the laparoscopic group (P = .008). Specific complications to the laparascopic technique were temporary damage to the obturator nerve in three patients. Conclusion: Laparoscopic occlusion of uterine vessels is a promising new method for treating fibroid-related symptoms, with less postoperative pain than embolization and comparable effects on symptoms. Ó 2004 Elsevier Inc. All rights reserved. KEY WORDS Leiomyoma Radiology Embolization Laparoscopy Leiomyomas of the uterus are common tumors of women, found in 40% of patients with heavy and/or prolonged menstrual bleeding. 1 The etiology of these processes is unknown, although fibroid growth is estro- gen dependent. The mechanism of their effect on men- strual blood loss is poorly understood but may involve abnormalities of local venous drainage, 2 as well as local changes in blood supply and the coagulation/fibrinolysis system. 3 Removal of submucous fibroids results in nor- malization of the bleeding pattern in the majority of pa- tients, 4 which supports the concept that fibroids cause menstrual problems. 5 The threshold for pressure symp- toms of a fibroid uterus is usually a size between 14 to 16 weeks. 6 Traditional operative treatments for symptomatic fi- broids are laparotomy with hysterectomy or myomectomy. * Reprint requests: Olav Istre, Department of Gynecology and Obstetrics, Ullevaal Hospital, the University of Oslo, N-0407 Oslo, Norway. E-mail address: [email protected] www.elsevier.com/locate/ajog American Journal of Obstetrics and Gynecology (2004) 190, 37e43 0002-9378/$ - see front matter Ó 2004 Elsevier Inc. All rights reserved. doi:10.1016/S0002-9378(03)00910-4

Laparoscopic occlusion of uterine vessels for the treatment of symptomatic fibroids: Initial experience and comparison to uterine artery embolization

Embed Size (px)

Citation preview

www.elsevier.com/locate/ajog

American Journal of Obstetrics and Gynecology (2004) 190, 37e43

Laparoscopic occlusion of uterine vessels for thetreatment of symptomatic fibroids: Initial experienceand comparison to uterine artery embolization

Kirsten Hald, MD,a Anton Langebrekke, MD,a Nils Einar Kløw, MD, PhD,b

Hans Jørgen Noreng, MD,b Anette Bugge Berge, MD,b Olav Istre, MD, PhDa,*

Departments of Obstetrics and Gynecologya and Radiology,b Ullevaal Hospital, University of Oslo, Oslo, Norway

Received March 27, 2003; revised June 9, 2003; accepted June 26, 2003

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––Objective: Our purpose was to evaluate the effects of laparoscopic occlusion of uterine vessels in

treating symptomatic fibroids and compare with embolization of the uterine arteries.Study design: We studied 46 premenopausal women, aged 43 (34-51) years with symptomaticuterine fibroids, undergoing radiologic embolization (n=24) and laparoscopy closure of theuterine arteries (n=22).

Results: The laparascopic technique reduced picture blood assessment score after 6 months by50% from an initial value of 345 (G288). Uterus volume was reduced by 37% (G18%), andthe dominant fibroid was reduced by 36% (G31%). Postoperative pain and use of pain relief dif-

fered significantly, requiring more pain medication after embolization: ketobemidon 38 mg com-pared with 16 mg in the laparoscopic group (P=.008). Specific complications to the laparascopictechnique were temporary damage to the obturator nerve in three patients.

Conclusion: Laparoscopic occlusion of uterine vessels is a promising new method for treatingfibroid-related symptoms, with less postoperative pain than embolization and comparableeffects on symptoms.

� 2004 Elsevier Inc. All rights reserved.

KEY WORDSLeiomyoma

RadiologyEmbolizationLaparoscopy

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Leiomyomas of the uterus are common tumors ofwomen, found in 40% of patients with heavy and/orprolonged menstrual bleeding.1 The etiology of theseprocesses is unknown, although fibroid growth is estro-gen dependent. The mechanism of their effect on men-

* Reprint requests: Olav Istre, Department of Gynecology and

Obstetrics, Ullevaal Hospital, the University of Oslo, N-0407 Oslo,

Norway.

E-mail address: [email protected]

0002-9378/$ - see front matter � 2004 Elsevier Inc. All rights reserved.

doi:10.1016/S0002-9378(03)00910-4

strual blood loss is poorly understood but may involveabnormalities of local venous drainage,2 as well as localchanges in blood supply and the coagulation/fibrinolysissystem.3 Removal of submucous fibroids results in nor-malization of the bleeding pattern in the majority of pa-tients,4 which supports the concept that fibroids causemenstrual problems.5 The threshold for pressure symp-toms of a fibroid uterus is usually a size between 14 to16 weeks.6

Traditional operative treatments for symptomatic fi-broids are laparotomywithhysterectomyormyomectomy.

38 Hald et al

These operations involve considerable morbidity.7

Although morbidity is reduced with endoscopic surgery,this technique is not widely available and has limitations.

A number of minimal invasive treatments are nowavailable for symptoms of this disorder. Surgical treat-ments with endoscopic technique include hysterectomy,myomectomy, and myolysis.8 Nonsurgical treatments in-clude uterine artery embolization and medical therapy.

The use of transcatheter uterine artery embolizationas a treatment for uterine fibroids represents a new ap-proach to the management of this common problem.Uterine artery embolization can produce a mean reduc-tion of 29% to 51% in uterine volume after 3-month fol-low-up, and with longer follow-up the shrinkagecontinues and there is no regrowth.9,10 Laparoscopic bi-polar coagulation of uterine arteries and anastomoticsites of uterine arteries with ovarian arteries representother modalities of avoiding hysterectomy in thesewomen.11 This article deals with the use of laparoscopicocclusion of the uterine arteries and the branches ofvessels from the ovaries to the uterus are compared withradiologic embolization of the fibroids.

Material and methods

The local Institutional Review Board and the Norwe-gian Medicines Control Authority approved the studyafter changes in patient’s information. The patients wererecruited from the outpatient clinic, and informedconsent was obtained from all women. The patientswere recruited when they were referred to the clinic forsymptomatic uterine fibroids. All women were premeno-pausal (serum follicle-stimulating hormone [s-FSH]!30 IU/L and 17b-estradiol [E2] O0.2 nmol/L).Assignment of patients to the two treatment groups(embolization or laparoscopic occlusion) was not ran-dom. Patients were assigned to embolization treatmentindependently of the size of the fibroid, and patientswere assigned to laparoscopic occlusion when the sizeof the fibroid did not exceed the umbilical level.

Exclusion criteria were current pregnancy, breast-feeding, current or recent pelvic inflammatory disease,abnormal Papanicolau smear, known endometriosis,breast cancer, a previous history of deep venous throm-bosis, thromboembolism or liver disease, and hormonetherapy during the last 3 months preceding the study.An endometrial biopsy (Pipelle) was performed in allcases at screening to exlude hyperplasia and carcinoma.

Uterine bleeding was quantified by the semiquantita-tive pictorial blood loss assessment score (PBAC), com-pleted by all subjects over a screening period of 2months before enrollment.12 Monthly scores were re-corded during the follow-up.

After theprocedure,weusedananalgesic regimencom-bining nonsteroidal anti-inflammatory drugs (NSAIDs)

and paracetamol-codeine combination in fixed dosesand patient-controlled intravenous narcotics (ketobemi-don) in variable doses. The postoperative pain duringthe hospital stay was judged with use of a visual analogscale (VAS). Calculation was performed every 4 hoursduring the first 12 hours in the ward and every 6 hours un-til the patient was discharged from hospital. The amountof analgesics used during the hospital stay was recorded.

The patients were followed up at the outpatient clinicwith visits scheduled at 6 weeks, 3 months, and 6 monthsafter the operation. At all visits, the bleeding diaries andPBAC chart for the preceding months were collected.The patients had a gynecologic examination; concomi-tant treatments and adverse events, defined as newsymptoms occurring after treatment, were recordedand classified, as well as the patient’s own judgment ofsymptoms on the follow-up visits.

Serum FSH and E2 levels were analyzed at screening,1 week, 3, 6, and 12 months after the procedure. Bloodfor hemoglobin and serum ferritin, C-reactive protein,and white blood cells were drawn at entry, after 24hours, 48 hours, 1 week, 1, 3, and 6 months.

Failure of the treatment was a patient who later un-derwent an intervention, such as hysterectomy, myo-mectomy, or placement of levonorgestrel system dueto unsatisfactory result of the procedure.

The evaluation of the uterus was done with both trans-vaginal ultrasound and magnetic resonance imaging(MRI). When the ultrasound findings were in doubt, sa-line infusion ultrasonography or hysteroscopy of the cav-ity was performed to exclude intrauterine pathologicconditions. Volume measurements of the fibroids anduterus were performed by ultrasound and MRI beforetreatment and after 1, 3, and 6 months. The volume ofthe dominant leiomyomata and uterus were calculated us-ing the formula for a prolate ellipsoid (L!W!D!0,5233), as described by Orsini et al.13

Laparoscopic technique

The patient were operated with the legs flat (‘‘frog-legposition’’), with no abduction of the legs. The legs wereelevated and placed in stirrups for the vaginal part of theoperation. A Foley bladder catheter was inserted in thebladder and kept in place for 24 hours.

An intraumbilical incision was made and pneumoper-itoneum was created with a Verres needle. One 10-mmand 2 5.5-mm trocars were inserted below and lateral tothe epigastric artery. The peritoneum overlying the exter-nal iliac artery was incised with a T incision between theround ligament and the infundibulopelvic ligament. Theiliac vessels were identified, and the retroperitoneal spaceswere developed. The uterine artery was occluded withan endoclip at the level of the internal iliac artery. Theidentical procedure was performed on the anterolateralside.

Hald et al 39

The collateral arteries between the ovaries and uterus(in the utero-ovarial ligament) were coagulated usinga bipolar forceps. Five women had an additional steril-ization by tubal coagulation. Additional surgery washad by two: one patient had a subserous fibroid re-moved during the laparascopic prosedure, and the otherpatient had an endometrial polyp removed by transcer-vical resection. Both were excluded from the clinical fol-low-up in this protocol.

The transcatheter embolization

The unilateral right femoral artery was punctured anda sheath with an inner diameter of 1.3-1.7 mm placed.The uterine arteries were intubated with a 65-cm longcatheter withCobra curve. The catheter was gently placedwith use of a soft and angled Teflon-coated wire and con-nected to a pressure transducer. If spasm was noticed bypressure drop or slow antegrade flow in the uterine artery,200 mg of nitroglycerin and/or nifedipine 5 mg was in-jected intra-arterially; if spasm continues, a 1-mm micro-catheter was placed and the Cobra catheter pulled backinto the hypogastric artery. The only diagnostic angiogra-phy performed was the one to place the catheter into theright position. Both the uterine arteries were embolizedwith 355 to 500 mm of polyvinyl alcohol particles (Con-tour, Boston Scientific, Paris, France). The particles wereinjected slowly during fluoroscopywith 2- to 10-mL syrin-ges until the flowwas nearly stopped.No further proximalocclusion with coils or Gelfoam particles was performed.Immediately prior to the procedure cefalotin 2 g (Keflin,Eli Lilly & Co, Indianapolis, Ind) and metronidazol1.5 g (Flagyl, Aventis Pharma AS, Lysaker, Norway)were given, as well as suppositories of diclofenac 100 mg(Voltaren, Novartis Norge AS, Oslo, Norway) and para-cetamol 800 mg+codeine phosphate (Paralgin Major,Weifa AS, Oslo, Norway). During the procedure diaze-pam 5 mg, atropine 0.5 mg, and heparin 5000 IE weregiven intravenously. All women were kept for two nightsin hospital afterward.

MRI evaluation

The MR studies were performed with a 1.5T Magnet(Gyroscan NT Intera Philips, Best, The Netherlands).

Table I Demographic and baseline parameters

Embolization(n = 24)

Laparascopy(n = 22) P value

Age 41,96 44,27 .08Body mass index 25,88 23,27 .04Menorrhagia only 5 6Bulk symptoms only 5 1Both menorrhagiaand bulk symptoms

14 15

With turbospin echo (TSE), T1-weighted pulse sequenceimages were obtained in the transverse plane. With useof T2-weighted TSE sequences, imaging was performedin the transverse and the sagittal plane. Finally, trans-verse fast-field echo (FFE) images were acquired afterrapid intravenous administration of gadopentetate di-meglumine 0.1 mmol/kg/body wt (Magnevist, Schering,Stabekk, Norway). Images were obtained every 5 sec-onds between 30 and 180 seconds after contrast injec-tion. The total uterine volume and the volume of thelargest fibroid were calculated from the sagittal andthe transverse T2 images.

Statistics

Power (1eb) calculations for three main outcome varia-bles: Difference between embolization and laparoscopicocclusion of the uterine arteries for (1) 6-month PBACscores, (2) 6-month uterine volume, and (3) pain scoredifferences post procedure. According to the data of lap-aroscopic occlusion, giving a reduction of pain reliefmedication of at least 25% with a power of 80%, 43patients in each group would be needed.

The data are presented in mean values (1 SD). ThePBAC scores were analyzed using Wilcoxon rank sumtest, Wilcoxon signed rank test, and Friedman two-way ANOVA. Other variables were tested usingANOVA, repeated measures ANOVA, Fisher exact test,or log-rank test, besides those above. The level of sig-nificance was set at P!.05. The data program usedwas SPSS (SPSS Institute, Inc, Chicago, Ill).

Results

Table I shows that the patients were of the same age.Body mass index (BMI) was larger in the embolizationgroup, and these patients were often more nulliparous(79%) than the laparascopic patients (45%). Forty-oneof the patients were of white ethnicity, 2 were African,1 of Arabic descent, and 2 of Indian heredity. Seven pa-tients were smokers, equal in two treatment groups. Pre-vious sterilization was seen in 2 women. Bulk symptomswith feeling of pressure and some degree of bladdersymptoms (frequency, urgency, and nocturia) were en-countered in 35 of the women; pressure symptoms alongwith menorrhagia were seen in 29 women, and menor-rhagia only in 11, no difference between the groups.The uterus volume was larger in the embolization group(833 mL vs 665 mL). Baseline PBACs recorded were 374and 459, respectively (Table II and III), with no signifi-cant difference between the treatment groups.

Closure of the uterine vessels by laparoscopic ap-proach was carried out successfully in all 22 patients.Suspicion of an affection of the obturator nerve wasraised in 3 patients in the laparoscopy group. Thesepatients complained of skin sensibility disturbance and

40 Hald et al

Table II Uterus and fibroid size during follow-up

Embolization Laparoscopy

n =Preoperativevalue SD

Red 6mo (%) SD n =

Preoperativevalue SD

Red 6mo (%) SD

PBAC (mean) 18 400 261,59 66,49 28,47 16 345 287,67 50,02 33,92Dom fibroid ULS(mean ccm)

19 263 196,28 54,64 28,79 17 187 140,52 45,34 27,72

Dom fibroid MRI(mean ccm)

21 293 245,20 45,12 27,99 15 232 157,91 36,23 30,78

Uterus volume MRI(mean ccm)

21 833 469,35 40,09 19,59 15 665 375,80 36,74 17,79

Table III Bleeding pattern during follow-up

NoPreoperativePBAC values SD

PostoperativePBAC values SD

Reduction(%) SD

EmbolizationMean preoperative PBAC value 23 374 258Mean PBAC 1-mo control 20 391 257 110 83 64 27Mean PBAC 3-mo control 21 400 253 116 97 63 29Mean PBAC 6-mo control 18 400 262 98 64 67 29

LaparoscopyMean preoperative PBAC value 21 459 408Mean PBAC 1-mo control 19 478 420 251 356 37 45Mean PBAC 3-mo control 17 410 386 164 154 52 23Mean PBAC 6-mo control 16 345 288 148 129 50 34

reduction of adduction of the leg corresponding toinnervations of the nerve, confirmed by a neurologist.The symptoms disappeared before 3-month control in1 of the patients and before 6-month control in thesecond. The third improved after 6-month control, butshe still complained of some muscle weakness and lackof sensibility. One laparascopic patient had pulmonaryembolus postoperatively.

Embolization was technically successful in all butone. Bilateral spasm prevented the embolization to bedone. One of the patients was embolized unilaterally be-cause one uterine artery supplied the whole myoma andno contralateral uterine artery could be found. No in-hospital complications were recorded.

The dominant fibroids measured by ultrasound beforetreatment was 263 mL (196) and 187 mL (141) in theembolization and the laparoscopic group. The volumeof the dominant fibroid measured by MRI was 293mL (245) and 232 mL (157), and the volume of theuterus was 833 mL (469) and 665 mL (376), respectively.No significant difference was seen between the groups(Table II). In both the embolization and the laparoscopygroup, a significant reduction from baseline to the 6months’ value was seen for both the dominant fibroidand the uterus. There were no significant differences be-tween the groups.

With a VAS scale, the postoperative pain was regis-tered by 43 of the patients. In the embolization group1.9 (1.8) cm was recorded compared to 1.4 (1.4) cm inthe laparoscopy group (P=.40). The use of ketobemi-don differed significantly between the two groups. Theconsumption after embolization treatment was 38 mg(19.5) compared with 16 mg (13) in the laparoscopic(P=.00). Three patients showed elevated fever 3 to 8days after the embolization procedure with prolongedincreased C-reactive protein (CRP); however, no risein the white blood cell count level was found, and addi-tional treatment was not needed.

Early and temporary elevation of FSH levels wereseen in four women after treatment (O30). Two (47and 49 years old) of these were in the laparoscopygroup, and 2 (44 and 45 years old) in the embolizationgroup. Another patient treated by embolization at age51 years showed normal hormone levels before, after 7and 30 days after treatment, but menopausal levels by3-month control.

There were 38 patients with menorrhagia, 19 in eachtreatment group. All the patients treated with emboli-zation reported less bleeding after 3months; the reductionin PBACvaluewas 63%. Seventeen of the patients treatedwith laparoscopy reported less bleeding after 3 months;a 50% bleeding reduction was seen in these patients.

Hald et al 41

During the 6-month follow-up period, 2 patients in eachgroupwere excluded because of other treatment; 1 patientin each group was lost from clinical control (Figure). Ofthe remaining 32 patients, 15 of 16 patients treated withembolization reported the same amount of bleedingreduction. In patients treated with laparoscopy, 14 of 16patients reported a reduction in bleeding after 6 monthsand were satisfied with the reduction of the fibroid andthe improvement of menorrhagia.

It was then necessary to perform four hysteroscopyoperations and one dilatation and curettage during thefollow-up period (Figure), three in the laparoscopicgroup and two after embolization. One patient in eachgroup had pain and discharge together with ongoingfibroid expulsion. One avascular fibroid was removedfrom the uterine cavity after 6 months after embolizationfor no symptoms, one embolization patient had expul-sion of necrotic fibroid tissue, and one in the laparoscopicgroup had no effect on heavymenstrual bleeding and wastreated with transcervical resection of endometrium com-bined with levonorgestrel (Mirena) coil insertion. Twohysterectomies were necessary, one because of lack of ef-fect of the laparoscopic procedure. We tried to performa hysteroscopic resection of a fibroid; however, majorbleeding instantly occurred and a hysterectomy was per-formed (Figure). One embolization patient was operatedafter 4 months; at 3-month control a large uterus hadshrunken more than 50%, but there were relapses of fe-ver, discharge, and elevation of CRP and white bloodcount. She refused to have her uterus removed until 4

Figure Clinical follow-up.

months after the procedure, when she eventually hada hysterectomy. The uterus was totally necrotic with a fis-tula between the appendix and the uterine cavity.

Comment

Treatment of fibroids has become more complex sincemore treatment options have become available. Thechoice of which treatment is best involves balancing pa-tient wishes, expected outcomes, complications, andcost-effectiveness and quality-of-life issues. There is a hi-erarchy of treatments that should take into account bothefficacy and patient acceptability. Myomectomy by hys-teroscopic and laparoscopic procedures need to be con-sidered, as well as open surgery. Recently, interventionalradiologic procedures such as uterine artery emboliza-tion have become available. Laparoscopic uterine arteryocclusion has been proposed, but there is limited experi-ence with this technique and the short- and long-termeffects on fibroids are not known. This study was,therefore, performed to evaluate the effect of lapara-scopic occlusion and to compare it with the emboliza-tion technique.

Many women still consider the uterus an importantaspect of their femininity and those seeking nonsurgicaloptions should be thoroughly counseled about uterinefunction and how it relates to sexuality. Eighty-fourconsecutive women with symptomatic leiomyoma pre-senting for UAE completed a questionnaire that in-quired about their pelvic symptoms and the issues thatwere important in their decision to request UAE.14 Al-though the majority of women wanted a treatment thatwould give permanent relief of symptoms and thoughtUAE would do so, other factors frequently cited in thedecision making included quality-of-life reasons, suchas the desire to avoid adverse effects of other treatments,anticipated prolonged postoperative recovery from sur-gery, and avoiding surgery. Many women consideredthe uterus an important female organ, believed thatthe uterus was a source of femininity, stated that theuterus was necessary to maintain self-image, and re-ported that the uterus was necessary to maintain sexualimage. We found the same decision-making reasons inour patients, and they were all very well aware of alter-native options, such as myomectomy and hysterectomyin our department, but they all chose to have the uteruspreserved.

We would acknowledge that the ‘‘power’’ of the studyis low across all variables; however, this study is a pilotstudy, not intended to show definitive differences. Forexample, at a ‘‘power’’ of 80%, to show a difference inuterine volume at 6 months as shown in the presentedstudy (40% vs 36.7%) at the P!.05 level (a=.05),you would need a sample size of 2606 for both treatmentor a total study size of 5212!

42 Hald et al

This article presents two different modalities to indi-rectly treat fibroid by elimination of arterial supply.Since the first paper by the radiologist Ravina,9 thou-sands of embolizations have been performed aroundthe world, and the results on bleeding, pressure symp-toms, and fibroid shrinkage have been good. With theintroducing of laparoscopic occlusion, the patients canbe taken care of by the gynecologist, supplemental pro-cedures can be done at the same time such as steriliza-tion and transabdominal myomectomies, and thepatients may have less risk of complications. However,there are concerns whether occlusion of the central partof the uterine artery will have any short- and long-termeffects on the fibroids. The technique has recently beendescribed and the initial results were good.15 The tech-nique may include laparoscopic bipolar coagulation ofuterine vessels alone,16 or both occlusion of the uterinearteries and coagulation of arterial supply from ovarianarteries.11 In this study, we occluded the uterine arteryproximally with endoclips at the level of the anterior di-vision of the internal iliac artery. The collateral arteriesbetween the ovaries and uterus in the utero-ovarial liga-ment were coagulated using a bipolar forceps. It is pos-sible that occlusion of both the uterine arteries and theovarian collaterals may improve the clinical outcome,but we cannot from this study make such a conclusion.In the current study, we recorded definite reduction inmenstrual bleeding and the fibroids and the uterus werereduced in size. Actually, the shrinkage and the reduc-tion in bleeding were close to what was observed afterthe embolization technique. The patients in this studywere selected for each treatment options, with larger fi-broids in the embolization group. To decide whetherthese two different techniques have similar effects onsymptoms and size of the uterus a comparative studyshould be done. We have recently included patients forsuch a study.

Postoperative pain is an important issue after uterineocclusion techniques. Both modalities are connectedwith major pain needing a postoperative pain regimenand hospitalization. In this study, significant and impor-tant difference was seen with a high power estimate. Thelaparascopic group required less pain medication after-ward than the embolization group. Several studies haveemphasized the importance of a pain regimen, and in thecurrent study a self-adjusted pain relief was used. It ispossible that the laparascopic patients may be dis-charged earlier and even be done as outpatients. Theo-ries have been proposed to explain the reason of thepostoperative pain.19 The polyvinyl alcohol particles ad-here to the vessel wall, causing slow flow within that ves-sel. The result is intraluminal thrombus formation,inflammatory reaction, foreign body reaction, and focalangionecrosis of the vessel wall. The foreign body reac-tion induced by PVA is reported to persist up to 28months after embolization.18 Embolization causes clots

to form in myometrial arteries by particles slowing flowin some of the myometrial arteries (only some, not all).When flow is sufficiently slow in an arterial area, thatarea clots. Occlusion of the uterine arteries by laparos-copy causes clots to form in the myometrial arteries(and veins), but to do so without leaving small particlesin myometrial arteries. After the myometrial arteries areclotted, either by embolization or by laparoscopic clip-ping, clots in these arteries lyse, and the myometriumis reperfused in those arteries that are occluded onlyby clot. If a myometrial artery is occluded by PVA, itcannot reperfuse. Consequently, after embolization, re-perfusion of the myometrium occurs more slowly andreperfusion is less complete than reperfusion followinglaparoscopic uterine artery occlusion. The PVA particlesget in the way of the lysis/reperfusion process.17

Another question that has been raised is how the hor-monal function is altered after these procedures. In somepatients, elevated hormone values were found; however,this might be explained by the increasing age of the pa-tients. The same was found in another study. Most pa-tients had no change in ovarian function as measuredby basal FSH after UAE. For patients aged 45 yearsor older, there is approximately a 15% chance of an in-crease in basal FSH into the perimenopausal range.19

Four of 183 patients had premature menopause afterembolization in another study. There were three criteriafor failure, of which a patient had to meet only one: hys-terectomy, !10% shrinkage of myoma 6 months afterUFE, or worsening symptoms after UFE. No variablesof age or size of the uterus could be shown to predictfailure. Patients who had undergone earlier pelvic sur-gery were more likely to fail UFE.20 According to ourfindings and the literature, interference of the uterine ar-tery as was done in the present study do not affect men-opausal age.

Submucous fibroid expulsion of fibroids has been re-ported21 and it occurs after uterine artery treatment in-dependently of the technique used. The fibroid seems todecrease in size and abort into the uterine cavity aftertreatment. It is of great benefit to the patients that con-trols are performed by a gynecologist. In our depart-ment we had three cases of pain and bleeding aftertreatment; these patients could be treated with hystero-scopic techniques.

In our patient group we saw equal complications inboth treatment modalities. Comparing the literature, aperiprocedural complication rate of 8.5% was seen in400 consecutive patients. There were 10 in-hospital com-plications and an additional 27 complications within thefirst 30 days; subsequently, no deaths and no major per-manent injuries occurred. One patient required a hyster-ectomy as a result of a complication, and one patienthad undiagnosed leiomyosarcoma at the time of UFE.22

Hysterectomies also encountered in our patient and wastreated according to general surgical indications.

Hald et al 43

As a result of lack of experience we saw some tempo-rary affection of the obturator nerve, this encountered inthe beginning of the laparoscopic procedures. Toorough manipulation of the nerve seems to be our expla-nation of these finding; however, the condition was tem-porary.

These preliminary data indicate promising equal re-duction of symptoms related to uterine leiomyomasindependent of method used to treat the fibroid. Theimmediate postoperative pain seems to be less severe af-ter laparoscopic closure than after radiologic emboliza-tion of the uterine arteries.

Both radiologic and laparoscopic occlusion tech-niques are potential treatment options in the treatmentof fibroids. However, both techniques are associatedwith a high level of skill, and consequently, it shouldbe selected to special centers with interest in this field.The complication rate is of significance, but is the samein both groups. We find of importance to implementa gynecologist in the treatment of fibroids; during lapa-roscopy, we will achieve a better view of the pelvic or-gan. Pathologic conditions might be found and thepatient can be counseled accordingly. We do believe thatthe fibroid should not exceed the umbilical level.

References

1. Zimmermann R. Dysfunctional uterine bleeding. Obstet Gynecol

Clin North Am 1988;15:107-10.

2. Farrer-Brown G, Beilby JOW, Tarbit MH. Venous changes in the

endometrium of myomatous uteri. Obstet Gynecol 1971;38:743-51.

3. West CP, Lumsden MA. Fibroids and menorrhagia. Baillieres Clin

Obstet Gynaecol 1989;3:357-74.

4. Broadbent JA, Magos AL. Menstrual blood loss after hystero-

scopic myomectomy. Gynaecol Endosc 1995;4:41-4.

5. Buttram VC, Jr, Reiter RC. Uterine leiomyomata: etiology,

symptomatology, and management. Fertil Steril 1981;36:433-45.

6. Rybo G. Menstrual blood loss in relation to parity and menstrual

pattern. Acta Obstet Gynecol Scand 1966;45(Suppl):25-45.

7. Dicker RC, Greenspann JR, Strauss LT, et al. Complications of

abdominal and vaginal hysterectomy among women of reproduc-

tive age in the United States. Am J Obstet Gynecol 1982;144:841-7.

8. Gaglione R, Cinque B, Parapatti L, Careddu G, Lafuenti GA,

Lemmo G. Usefulness of a hysteroscopic follow-up on patients

with breast cancer in pre- and post-menopausal age. Eur J

Gynaecol Oncol 1989;10:421-4.

9. Ravina JH, Herbreteau D, Ciraru-Vigneron N, Bouret JM,

Houdart E, Aymard A, et al. Arterial embolisation to treat uterine

myomata. Lancet 1995 Sep 9;346:671-2.

10. Hutchins FL, Jr, Worthington-Kirsch R. Embolotherapy for

myoma-induced menorrhagia. Obstet Gynecol Clin North Am

2000;27:397-405, 408.

11. Liu WM, Ng HT, Wu YC, Yen YK, Yuan CC. Laparoscopic

bipolar coagulation of uterine vessels: a new method for treating

symptomatic fibroids. Fertil Steril 2001;75:417-22.

12. Higham JM, O’Brian PMS, Shaw RW. Assessment of menstrual

blood loss using a pictorial chart. BJOG 1990;97:734-9.

13. Orsini LF, Salardi S, Pilu G, Bovicelli L, Cacciari E. Pelvic organs

in premenarcheal girls: real-time ultrasonography. Radiology

1984;153:113-6.

14. Nevadunsky NS, Bachmann GA, Nosher J, Yu T. Women’s

decision-making determinants in choosing uterine artery emboli-

zation for symptomatic fibroids. J Reprod Med 2002;46:870-4.

15. Yen YK, Liu WM, Yuan CC, Ng HT. Laparoscopic bipolar

coagulation of uterine vessels to treat symptomatic myomas in

women with elevated Ca 125. J Am Assoc Gynecol Laparosc 2001;

8:241-6; 2003.

16. Lichtinger M, Hallson L, Calvo P, Adeboyejo G. Laparoscopic

uterine artery occlusion for symptomatic leiomyomas. J Am Assoc

Gynecol Laparosc 2002;9:191-8.

17. Burbank F, Hutchins FL, Jr. Uterine artery occlusion by

embolization or surgery for the treatment of fibroids: a unifying

hypothesis-transient uterine ischemia. J Am Assoc Gynecol

Laparosc 2002;7(Suppl):S1-S49.

18. Tomashefski JF, Jr, Cohen AM, Doershuk CF. Longterm

histopathologic follow-up of bronchial arteries after therapeutic

embolization with polyvinyl alcohol (Ivalon) in patients with cystic

fibrosis. Hum Pathol 1988;19:555-61.

19. Roth AR, Spies JB, Walsh SM, Wood BJ, Gomez-Jorge J, Levy

EB. Pain after uterine artery embolization for leiomyomata: can its

severity be predicted and does severity predict outcome? J Vasc

Interv Radiol 2002;11:1047-52.

20. McLucas B, Adler L, Perrella R. Uterine fibroid embolization:

nonsurgical treatment for symptomatic fibroids. J Am Coll Surg

2001;192:95-105.

21. Abbara S, Spies JB, Scialli AR, Jha RC, Lage JM, Nikolic B.

Transcervical expulsion of a fibroid as a result of uterine artery

embolization for leiomyomata. JVasc IntervRadiol 1999;10:409-11.

22. Spies JB, Spector A, Roth AR, Baker CM, Mauro L, Murphy-

Skrynarz K. Complications after uterine artery embolization for

leiomyomas. Obstet Gynecol 2002;100:873-80.