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Izhodišča: Po histeroskopski sterilizaciji s sistemom Essure (Bayer AG, Leverkusen, Nemčija) je s potrditvenim testom potrebno določiti uspešnost sterilizacije. Zlati standard za potrditev uspešnosti histeroskopske sterilizacije s sistemom Essure predstavlja histerosalpingografija (HSG). Novejša, manj invazivna metoda določanja prehodnosti jajcevodov v sklopu obravnave neplodnosti je kontrastna histerosalpingosonografija s peno (HyFoSy). Do sedaj še ni bilo raziskave, ki bi ovrednotila HyFoSy pri določanju uspešnosti histeroskopske sterilizacije s sistemom Essure, prav tako pa ne raziskave, ki bi primerjala tri različne potrditvene teste. Namen raziskave je bil ovrednotiti natančnost dvodimenzionalne (2D) transvaginalne ultrazvočne (UZ) preiskave in HyFoSy v primerjavi s HSG pri določanju uspešnosti histeroskopske sterilizacije s sistemom Essure. Metode: Opravili smo prospektivno raziskavo, v katero smo vključili 90 pacientk, napotenih na histeroskopsko sterilizacijo s sistemom Essure. Dvanajst tednov po sterilizaciji smo pri vseh opravili 2D-transvaginalno UZ-preiskavo, s katero smo določali položaj mikrovsadkov, ki smo ga opredelili kot zadovoljiv ali nezadovoljiv. Temu sta sledili HyFoSy in HSG, s katerima smo določali zaporo jajcevodov, ki smo jih opredelili kot prehodne ali neprehodne. Pri pacientkah s prehodnimi jajcevodi pri HSG smo opravljali dodatne HSG v 3-mesečnih intervalih do potrditve neprehodnosti jajcevodov. Rezultati: Od 90 vključenih pacientk je celoten protokol raziskave opravilo 86 pacientk s 170 jajcevodi. Položaj mikrovsadkov, ki smo ga določali z 2D-transvaginalno UZ-preiskavo, smo primerjali z neprehodnostjo jajcevodov pri HSG. Neprehodnost jajcevodov smo določali s HyFoSy kot indeksnim testom in HSG kot referenčnim standardom. Občutljivost in specifičnost položaja mikrovsadka pri določanju uspešnosti histeroskopske sterilizacije sta bili 88,7 % (95 % interval zaupanja (IZ), 83 %–93 %) in 9,1 % (95 % IZ, 0 %–41 %), pozitivna in negativna napovedna vrednost pa 93,4 % (95 % IZ, 88 %–97 %) in 5,2 % (95 % IZ, 0 %–26 %). Stopnja ujemanja med ustreznim položajem mikrovsadka in zaporo jajcevoda ter neustreznim položajem in prehodnostjo jajcevoda je bila 83,5 % (95 % IZ, 77 %–89 %). Občutljivost in specifičnost HyFoSy pri določanju uspešnosti histeroskopske sterilizacije s sistemom Essure sta bili 100 % (95 % IZ, 97 %–100 %) in 54,6 % (95 % IZ, 23 %–83 %), pozitivna in negativna napovedna vrednost pa 97,0 % (95 % IZ, 93 %–99 %) in 100 % (95 % IZ, 42 %–100 %). Natančnost HyFoSy je znašala 97,1 % (95% IZ, 93 %–99 %). Ob koncu raziskave se je 98,8 % pacientk lahko zaneslo na histeroskopsko sterilizacijo s sistemom Essure za namene trajnega preprečevanja zanositve. Dolgoročnih zapletov nismo zabeležili. Zaključki: Stopnja ujemanja med ustreznostjo položaja mikrovsadka pri 2D-transvaginalni UZ-preiskavi in uspešnostjo histeroskopske sterilizacije s sistemom Essure pri HSG je bila nižja od pričakovane. Pacientke z zadovoljivim položajem mikrovsadka pri 2D-transvaginalni UZ-preiskavi se samo na osnovi 2D-transvaginalne UZ-preiskave niso mogle zanesti na Essure za trajno preprečevanje zanositve. Prehoden jajcevod pri HyFoSy ni potreboval dodatne potrditve prehodnosti s HSG. Vendar se pacientke s prehodnim jajcevodom niso mogle zanesti na Essure za trajno preprečevanje zanositve. Zato smo pri njih svetovali kontrolni potrditveni test v rednih 3-mesečnih intervalih do potrditve zapore jajcevoda. Tudi pacientke z neprehodnimi jajcevodomi pri HyFoSy se niso mogle zanesti na Essure, saj stopnja ujemanja neprehodnosti jajcevoda med HyFoSy in HSG ni bila 100 %. Neprehodnost jajcevoda pri HyFoSy bi bilo potrebno potrditi s HSG. Ugotavljamo, da HSG ostaja zlati standard pri potrjevanju neprehodnosti jajcevodov po histeroskopski sterilizaciji s sistemom Essure in s tem njene uspešnosti. Introduction: After Essure hysteroscopic sterilization (Bayer AG, Leverkusen, Germany) a confirmation test is performed to ensure successful sterilization. The reference standard for confirmation of tubal occlusion after Essure hysteroscopic sterilization is hysterosalpingography (HSG). Hysterosalpingo-foam sonography (HyFoSy) has been suggested to be newer and possible less invasive alternative to HSG during infertility workup. HyFoSy as the Essure hysterosopic sterilization confirmation test has never been investigated, as have never been three different confirmation tests. The purpose of our study was to evaluate the accuracy of 2-dimensional (2D) transvaginal ultrasonography and HyFoSy compared to HSG for assessment of the efficacy of Essure hysteroscopic sterilization. Methods: A prospective study included 90 patients who underwent Essure hysteroscopic sterilization. Twelve weeks after the sterilization, 2D transvaginal ultrasonography was performed to assess the microinsert position, which was defined as satisfactory or unsatisfactory. It was followed by HyFoSy and HSG for evaluation of tubal occlusion, where fallopian tubes were defined as occluded or patent. Patients with patent fallopian tubes on HSG were scheduled for additional HSG procedures at 3-month intervals until the tubal occlusion was documented. Results: Of 90 enrolled patients, 86 patients with 170 fallopian tubes underwent the complete imaging protocol. Microinsert position was evaluated by 2D transvaginal ultrasonography and was compared to tubal occlusion at HSG. Tubal occlusion was evaluated by HyFoSy as an index test and HSG as a reference standard. Sensitivity and specificity of microinsert position on success of Essure hysteroscopic sterilization were 88.7% (95% confidence interval [CI], 83%–93%) and 9.1% (95% CI, 0%–41%), whereas positive and negative predictive values were 93.4% (95% CI, 88%–97%) and 5.2% (95% CI, 0%–26%). The concordance rate between a satisfactory microinsert position and tubal occlusion and an unsatisfactory microinsert position and tubal patency was 83.5% (95% CI, 77%–89%). The accuracy of HyFoSy was 97.1% (95% CI, 93%–99%). The sensitivity and specificity were 100% (95% CI, 97%–100%) and 54.6% (95% CI, 23%–83%), whereas the positive and negative predictive values were 97.0% (95% CI, 93%–99%) and 100% (95% CI, 42%–100%), respectively. At the end of our study, 98.8% of patients could rely on Essure hysteroscopic sterilization for pregnancy prevention. No long-term complications were reported. Conclusions: The concordance rate between microinsert position on 2D transvaginal ultrasonography and tubal status on HSG was lower that expected. According to the results, patients with satisfactory microinsert position should not rely solely on Essure for pregnancy prevention. A patent fallopian tube on HyFoSy would not need a confirmation by HSG. However, patients with patent tubes cannot rely on Essure and are advised to have additional tubal patency testing at 3-month intervals until tubal occlusion is documented. Given that the concordance rate for tubal occlusion between HyFoSy and HSG was not 100%, patients with occluded fallopian tubes on HyFoSy also could not rely on Essure for pregnancy prevention. An occluded fallopian tube on HyFoSy should be confirmed by HSG. Therefore, we conclude that HSG remains the reference standard for confirmation of tubal occlusion to ensure successful Essure hysteroscopic sterilization. |
