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Concomitant NovaSure Endometrial Ablation and Essure Tubal Sterilization: A Review of 100 Cases
GYNAECOLOGY
Concomitant NovaSure Endometrial Ablation and Essure Tubal Sterilization: A Review of 100 Cases Carmen N. Mircea, MD,1 Ciaran Goojha, MD,1 John A. Thiel, MD1,2 1
Department of Obstetrics and Gynecology, University of Saskatchewan, Saskatoon SK
2
Department of Obstetrics and Gynecology, Regina Qu’Appelle Health Region, Regina SK
Abstract
Résumé
Objective: To assess the success rate, complications, and technical difficulties of concomitant NovaSure radiofrequency global endometrial ablation (NS-GEA) and Essure hysteroscopic sterilization (EHS).
Objectif : Évaluer le taux de réussite, les complications et les difficultés techniques de la tenue concomitante des interventions NovaSure radiofrequency global endometrial ablation (NS-GEA) et Essure hysteroscopic sterilization (EHS).
Methods: We conducted a retrospective descriptive study of 100 women undergoing concomitant NS-GEA and EHS for abnormal uterine bleeding. The combined procedure was completed using conscious sedation, in an outpatient setting. Patients were asked to return three months post procedure to have proper microinsert positioning confirmed by hysterosalpingogram, ultrasound, and/or pelvic radiograph.
Méthodes : Nous avons mené une étude descriptive rétrospective portant sur 100 femmes qui se soumettaient à des interventions NS-GEA et EHS concomitantes visant un saignement utérin anormal. L’intervention combinée a été menée sous sédation consciente, dans une unité de soins ambulatoires. On avait demandé aux patientes de revenir, trois mois à la suite de l’intervention, pour la tenue d’un hystérosalpingogramme, d’une échographie et/ou d’une radiographie pelvienne visant à confirmer le positionnement adéquat du micro-insert.
Results: An average of five micro-inserts were left trailing into the endometrial cavity. The mean duration of the procedure was on average 17.1 minutes. Eighty-seven patients returned for follow-up. The combined procedure was successful in 80 of these 87 patients (92%) and not successful in seven patients (8%). To improve visualization of the tubal ostia, 25 patients had suction curettage after NS-GEA, with no significant increase in the procedure time (P = 0.927). Technical difficulties included impaired visualization of the tubal ostia (7.4%), difficulty in visualizing or counting micro-inserts after placement (3.2%), and resistance to micro-insert placement (3.2%). The procedure complications were intrauterine synechiae (5.7%), endometritis (2.3%), pain that required an emergency room visit (2.3%), and migration of micro-inserts with or without perforation (4.6%). Conclusion: Concomitant NS-GEA and EHS is a safe and efficient method of providing treatment for abnormal uterine bleeding and permanent female sterilization. The combined procedure can be safely moved from the operating theatre to an outpatient setting, completely independent of anaesthesia and day surgery services. Suction curettage should be considered before EHS. A small proportion of patients may develop post-procedure intrauterine synechiae that impaired the ability to document tubal occlusion by hysterosalpingogram.
Key Words: NovaSure radiofrequency global endometrial ablation, Essure hysteroscopic sterilization, abnormal uterine bleeding, intrauterine synechia Competing Interests: See Acknowledgements. Received on November 20, 2010 Accepted on December 13, 2010
Résultats : En moyenne, cinq micro-inserts ont été laissés dans la cavité endométriale. La durée moyenne de l’intervention a été de 17,1 minutes. Quatre-vingt sept patientes se sont présentées pour le suivi. L’intervention combinée a été couronnée de succès chez 80 de ces 87 patients (92 %) et s’est soldée en échec chez sept patientes (8 %). Pour améliorer la visualisation des orifices tubaires, 25 patientes ont subi un curetage par aspiration à la suite de l’intervention NS-GEA, sans que cela n’occasionne de hausse significative de la durée d’intervention (P = 0,927). Parmi les difficultés techniques, on trouvait la difficulté de visualiser les orifices tubaires (7,4 %), la difficulté de visualiser ou de dénombrer les micro-inserts à la suite du positionnement (3,2 %) et la résistance au positionnement des micro-inserts (3,2 %). Parmi les complications de l’intervention, on trouvait les synéchies intra-utérines (5,7 %), l’endométrite (2,3 %), la douleur nécessitant une consultation en salle d’urgence (2,3 %) et la migration des micro-inserts avec ou sans perforation (4,6 %). Conclusion : La tenue concomitante des interventions NS-GEA et EHS constitue un moyen sûr et efficace d’assurer la prise en charge du saignement utérin anormal et de procéder à une stérilisation permanente. L’intervention combinée peut être menée en toute sûreté au sein d’une unité de soins ambulatoires (plutôt qu’en salle d’opération), de façon tout à fait indépendante des services d’anesthésie et de chirurgie d’un jour. La tenue d’un curetage par aspiration devrait être envisagée avant de procéder à l’intervention EHS. Une faible proportion de patientes peut en venir à voir apparaître, à la suite de l’intervention, des synéchies intra-utérines nuisant à la capacité de documenter l’occlusion tubaire par hystérosalpingogramme. J Obstet Gynaecol Can 2011;33(4):361–366
APRIL JOGC AVRIL 2011 l 361
GYNAECOLOGY
INTRODUCTION
A
bnormal uterine bleeding is a common gynaecological problem that has significant impact on a woman’s quality of life and health care costs. Traditionally, the surgical treatment for abnormal uterine bleeding has been hysterectomy.1,2 A safe and effective minimally invasive surgical alternative to hysterectomy has been found in NovaSure global endometrial ablation.3 Endometrial ablation is not a sterilizing procedure, and pregnancy after ablation may be associated with severe adverse events for the fetus and mother such as miscarriage, abnormal placentation, intrauterine growth restriction, uterine rupture or preterm birth.4–7 Reliable contraception or permanent sterilization should therefore be offered to women of childbearing age undergoing the procedure. Since both GEA and Essure hysteroscopic tubal sterilization have been independently proven to be safe and efficient in controlling bleeding and providing reliable contraception, respectively, combining these two methods is an ideal solution.3,8–10 Moreover, the cost-effectiveness of combining these two procedures may be significant. Indeed, performing concomitant NS-GEA and EHS has been shown to be effective management for women with abnormal uterine bleeding requiring postNS-GEA permanent sterilization.11,12 However, previous studies have been based on small numbers of patients. There are no current restrictions in Canada regarding the performance of concomitant global ablation and Essure micro-insert placement. Because we are able to use ultrasound as a follow-up to assess micro-insert position,13 the potential for difficulty in interpreting the post-insertion hysterosalpingogram is not a concern. In the present study, we describe our five-year experience of performing 100 concomitant NS-GEA and EHS procedures, 98 of which were performed in an outpatient, ambulatory setting. This is the first study to describe the feasibility of concomitant NS-GEA and EHS procedure in an outpatient, ambulatory setting, completely independent from the operating room and anaesthesia services. MATERIALS AND METHODS
We conducted a retrospective descriptive study of 100 women who were scheduled to have concomitant NS-GEA and EHS performed between July 2004 and September ABBREVIATIONS EHS
Essure hysteroscopic tubal sterilization
GEA
global endometrial ablation
NS-GEA NovaSure global endometrial ablation
362 l APRIL JOGC AVRIL 2011
2009. These women were referred to our clinic because of abnormal uterine bleeding. They were evaluated by one physician (J.A.T.) and management options were discussed. Patients elected to undergo NS-GEA and therefore required proper counselling regarding a permanent and reliable contraception method. After discussion of the options for permanent contraception, the patients opted to undergo EHS. Full investigation of the abnormal uterine bleeding (including endometrial biopsy and pelvic ultrasound) was carried out to rule out contraindications to either NS-GEA or EHS. Informed consent was obtained from all patients. Procedures were performed at various times in the menstrual cycle. No routine pre-treatment of the endometrium was carried out. Most of the patients underwent the concomitant procedures in the Women’s Heath Centre, an outpatient department at the Regina General Hospital, not in the operating room, and did not require monitored anaesthesia care. Only two cases were carried out in the operating room. Specialized nursing staff received the patients and explained the procedure. The analgesia consisted of a combination of intravenous midazolam (1 to 2 mg) and fentanyl (2 μg/kg), and doses were titrated according to the patient’s level of discomfort. The clinical status of patients (blood pressure, heart rate, and oxygen saturation) was closely monitored by the bedside nurse, and additional analgesia and/or sedation was given if necessary. Paracervical nerve block was induced using lidocaine 1%. Hysteroscopy was initially performed using a 5.5 mm single channel continuous flow hysteroscope and a 2.7 mm lens (Circon AMCI, Toronto, ON) and using normal saline as the distension medium. The tubal ostia were identified and, after appropriate dilatation of the cervix, NS-GEA was performed. Twenty-five patients had suction curettage with no.8 suction curette after endometrial ablation in order to improve visualization of the tubal ostia. The hysteroscope was reinserted and, after inspection of the uterine cavity and localization of the tubal ostia, Essure micro-inserts were placed according to the manufacturer’s guidelines. After completion of the procedure, patients were transferred to the recovery area. Oral analgesia and antiemetic medication were provided as needed. We used single drug analgesia or combinations of ibuprofen, acetaminophen, acetaminophen with codeine, and promethazine. Patients were discharged from the ambulatory setting on the same day after the effects of conscious sedation had passed and patients were stable and comfortable.
Concomitant NovaSure Endometrial Ablation and Essure Tubal Sterilization: A Review of 100 Cases
Flow of study participants
Patients were instructed to use a reliable contraceptive method for three months after the procedure, and office staff arranged appointments for the three-month followup to confirm correct placement of the micro-inserts using hysterosalpingography, conventional and/or 3-D ultrasound, or pelvic X-ray.13–16 The results of these investigations were reviewed by a radiologist, and the position of the micro-inserts was deemed to be appropriate, not appropriate, or unsure. In case of uncertainty, a second confirmatory test (hysterosalpingogram or ultrasound) was performed. All data were collected by retrospective chart review. The population’s demographics, the time and details of the procedure, and medication dosage were characterized using descriptive statistics. Mann-Whitney test was used
to assess the time difference between procedures in which suction curettage was performed and those in which it was not performed. Ethics approval for the study was provided by the Ethics Review Board of Regina Qu’Appelle Health Region. RESULTS
The study flow chart is shown in the Figure. Six patients were excluded from the analysis because follow-up medical records could not be retrieved. The remaining 94 patients included in the study had a mean age of 39.5 ± 4.8 years (95% CI 38.5 to 40.5). The median parity was 2 (range 0 to 5), and mean body mass index was 29.2 ± 7.1 kg/m² (95% CI 27.7 to 30.7). APRIL JOGC AVRIL 2011 l 363
GYNAECOLOGY
Procedure time, NovaSure and Essure parameters Mean, SD (95% CI) Mean total procedure time (95% CI), min
17.1 ± 5.9 (15.9 to 18.3)
NovaSure ablation, cm Mean cavity length (95% CI)
5.2 ± 0.4 (5.1 to 5.3)
Mean cavity width (95% CI)
3.7 ± 0.7 (3.5 to 3.8)
Essure micro-inserts, n Mean, Micro-inserts on left side (95% CI)
4.5 ± 2.2 (4.0 to 4.9)
Mean, Micro-inserts on right side (95% CI)
4.9 ± 3.0 (4.3 to 5.5)
Conscious sedation was used in 92 of 94 patients (98%); two patients (2 %) had the procedure performed in the operating room under general anaesthesia. Intravenous midazolam and fentanyl was used for 87% of patients (81/93). In 11% of patients (10/93), a combination of diazepam and fentanyl was used for analgesia. The mean doses of IV midazolam, fentanyl, and diazepam were 1.2 ± 0.6 mg (95% CI 1.1 to 1.3), 168.5 ± 44.5 μg (95% CI 159.2 to 177.9), and 3.2 ± 1.2 mg (95% CI 2.4 to 4.1), respectively. Technical difficulties occurred in 14.9% of patients (14/94) during the procedure and consisted of impaired visualization of the tubal ostia (7/94; 7.4%), difficulty in visualizing and counting micro-inserts after placement (3/94; 3.2%), or resistance to micro-insert placement (3/94; 3.2%). In one case (1.1%) the Essure procedure could not be completed because of patient discomfort. Since only endometrial ablation was performed, and not concomitant NS-GEA and EHS, this case was removed from analysis and the remaining 93 patients were further analyzed (Figure). Total procedure time and procedure variables are summarized in the Table. Twenty-five of the 93 patients (27%) had suction curettage performed after NS-GEA to improve visualization of the tubal ostia. No significant increase in the duration of the procedure was noted in the patients who had suction curettage performed (16 minutes; range 10 to 33) compared with the non-suction curettage group (15 minutes; range 7 to 36) (P = 0.927). Post-procedure analgesia consisted of acetaminophen 650 mg (in 18.4% of patients), ibuprofen 400 mg (28.2%), oral combinations of acetaminophen and ibuprofen (32.6%), or acetaminophen with codeine and ibuprofen (2.2%). Seven patients (7.7%) received various combinations of acetaminophen, ibuprofen, promethazine, and acetaminophen with codeine. No post-procedure analgesia was required in 10.9% of patients. Eighty-seven of the 93 patients (93.5%) presented for the three-month confirmation follow-up of the Essure 364 l APRIL JOGC AVRIL 2011
micro-insert placement. Five (5.4%) patients failed to return for the follow-up, while one patient (1.1%) underwent hysterectomy before the time of the follow-up and thus did not require imaging. This patient requested total laparoscopic hysterectomy for chronic pelvic pain secondary to endometriosis. Essure micro-inserts were found to be properly positioned on assessment of the gross pathology of the specimen. During follow-up, bilateral tubal occlusion and/or proper micro-insert positioning was demonstrated in 80 of the returning 87 patients (92%) through hysterosalpingography, pelvic ultrasound and/or pelvic X-ray. The criteria for proper positioning of Essure micro-inserts were not met in the remaining seven patients (8.0%). Six patients (6.9%) showed unilateral tubal occlusion only, and in one case (1.1%) both micro-inserts were displaced into the uterine cavity. Only one of the 25 patients who had suction curettage after NS-GEA had improper micro-insert positioning. Six of the seven patients with a failed procedure, (85.7%) did not have suction curettage performed after NS-GEA. Proper micro-insert placement was documented by hysterosalpingography (21/80; 26.3%), ultrasound (56/80; 70%), or pelvic X-ray (3/80; 3.7%). When the ultrasound was not conclusive, hysterosalpingography was also performed for definitive confirmation. If hysterosalpingography was the initial confirmation test and showed inconclusive findings, ultrasound was performed. The three cases in which pelvic X-ray was used as the only follow-up test were the earliest cases in the study; at that time, pelvic X-ray was thought to provide sufficient evidence for confirmation of proper micro-insert placement. Intrauterine synechiae (5/87; 5.7%), endometritis (2/87; 2.3%), pain that required an emergency room visit (2/87; 2.3%), and migration of micro-inserts with or without perforation (4/87; 4.6%) were the short and long-term procedure complications. The uterine cavity after NS-GEA was not occluded in most cases in which hysterosalpingography was performed (16/21; 76.2%).
Concomitant NovaSure Endometrial Ablation and Essure Tubal Sterilization: A Review of 100 Cases
DISCUSSION
This is the first study to clearly show the feasibility, efficacy, and safety of moving this procedure from the operating theatre to an outpatient, ambulatory setting, completely independent from day surgery and anaesthesia services. Previously published studies have proven that performing the Essure procedure in an ambulatory setting results in a statistically significant cost saving when compared with traditional laparoscopic tubal sterilization performed in the operating room.17 Thus, we would expect to find similar savings when comparing the combined procedure performed in an outpatient, ambulatory setting with the combined procedure performed in the operating theatre. The device costs were covered for all patients by their provincial health care insurance. Our results agree with previously published studies reporting that concomitant NS-GEA and EHS is a generally safe, fast, and efficient method of providing both treatment for abnormal uterine bleeding and permanent female sterilization.11,12 Furthermore, recent data have shown that placement of Essure micro-inserts does not alter the ability to perform subsequent NovaSure ablation, supporting acceptable safety profiles for NovaSure following Essure placement.18 Unlike previously published studies,11,12 our study assesses the success rate, complications and technical difficulties of concomitant NS-GEA and EHS in a much larger cohort of patients. We also report a shorter total procedure time of 17.1 ± 5.9 min (95% CI 15.9 to 18.3) (Table). Patients tolerated the combined procedure well with IV conscious sedation and post-procedure oral analgesia. Only one patient was too uncomfortable after the NS-GEA to allow subsequent EHS. Although this patient ultimately did not have the combined procedure, we opted to keep this case in our study to illustrate that the inability to perform EHS after NS-GEA because of the patient’s discomfort is a rare but possible outcome. Uterine curettage and evacuation before endometrial ablation have been reported to improve post-ablation visualization of tubal ostia.11 A subgroup of patients in our study had suction curettage after the NS-GEA, and this procedure did not significantly alter the procedure time. Therefore, in order to decrease the amount of postablation intrauterine debris, suction curettage should be considered before tubal sterilization. We encountered the following three types of technical difficulties in our study. Because these technical difficulties
do not commonly occur when the procedures are performed individually, they are likely the result of combining the two procedures. 1. Impaired tubal visualization. This was the most common technical difficulty encountered in our study and was also reported by previous studies.11,12 Although we were still able to cannulate tubal ostia in most patients in whom tubal visualization was impaired, we observed that two of these patients were among the seven cases with failed tubal sterilization. One of these two patients was also found to have a bicornuate uterus, and this might have added to the technical challenge of the combined procedure. 2. Impaired visualization and/or impaired counting of the number of intrauterine Essure micro-inserts placed. This was due to the uterine debris resulting from the endometrial ablation. This occurred in three cases, but in all three bilateral proper micro-insert placement was confirmed at the three-month follow-up. 3. Resistance met at micro-insert placement. This could have been related to tubal spasm or previous tubal scarring. In all three patients in whom this problem occurred, the confirmatory test showed proper microinsert placement at three months post procedure. The last two of these technical difficulties encountered during combined NS-GEA and EHS have not previously been reported, most likely because of the small number of cases analyzed in prior studies. Seven patients did not meet the criteria for proper positioning of micro-inserts or bilateral tubal occlusion. The patient who was shown to have a bicornuate uterus and who had technical difficulties at the time of the procedure also developed bilateral displacement of microinserts in the uterine cavity. This suggests that patients with an identified uterine anomaly might not be ideal candidates for a combined NS-GEA and EHS procedure, already described as more technically challenging.11,19 Another patient with failed proper micro-insert positioning was among the cases in whom we encountered poor visualization of the ostia during the procedure. In one case we were not able to cannulate one ostium. In the remaining four cases, no obvious technical difficulties or complications were documented; this might also be explained by the reported increase in the difficulty of the combined procedures,11,19 especially related to poor visualization of the ostia. A previous study,11 however did not report that poor visualization of the ostia after
APRIL JOGC AVRIL 2011 l 365
GYNAECOLOGY
endometrial ablation interfered with the success rate of the combined procedure. This difference might be explained by the smaller number of patients studied. All patients with failed micro-insert placement or tubal occlusion underwent subsequent laparoscopic tubal ligation or successfully repeated EHS. Intrauterine synechiae, endometritis, pain requiring a visit to the emergency room, and micro-insert migration and/ or perforation were the short- and long-term postoperative complications observed in this study. The formation of intrauterine synechiae was found to be the most common post-procedure complication. Also described in prior studies, this problem was not previously observed to interfere with determining the location of micro-inserts or occlusion of tubes.11 This was not the case in our study, considering that in three out of the five patients diagnosed with uterine synechiae, the hysterosalpingogram failed to demonstrate tubal occlusion because of an inability to cannulate or properly fill the uterine cavity with contrast substance. However, we were able to confirm the proper placement of the device in these cases by ultrasound. Other complications included significant pain requiring a visit to the emergency room (two patients) or infection (two patients), suggesting a possible beneficial role of post-procedure prophylactic antibiotics. This subject is still controversial, and there is no evidence for or against the routine use of antibiotics.19 We did not administer antibiotics in this study. However, other authors reported routine prophylactic use of antibiotic.19 Three of the four patients found to have micro-insert migration/perforation at the three-month follow-up test were determined to have bilateral tubal occlusion on hysterosalpingography. Therefore, micro-insert migration does not necessarily imply tubal patency. CONCLUSION
This study concludes that concomitant NS-GEA and ESH is a safe, fast, and efficient method of providing treatment for abnormal uterine bleeding and permanent female sterilization in an outpatient setting, completely independent of anaesthesia and day surgery services. Difficulty in visualizing the tubal ostia after the NS-GEA was the most common technical challenge encountered and might have interfered with proper visualization and placement of Essure devices. Suction curettage improved visualization of the ostia after GEA and did not significantly alter the procedure time; it should therefore be considered before performing tubal sterilization. A small proportion of patients developed post-procedure intrauterine synechiae that impaired the ability to document tubal occlusion by hysterosalpingography, but not by ultrasound. 366 l APRIL JOGC AVRIL 2011
ACKNOWLEDGEMENTS
Dr Thiel is a consultant with Conceptus, Inc. REFERENCES 1. Duckitt K. Managing perimenopausal menorrhagia. Maturitas 2010;66:251–6. 2. Coulter A, Peto V, Jenkinson C. Quality of life and patient satisfaction following treatment for menorrhagia. Fam Pract 1994;11:394–401. 3. Gallinat A. NovaSure impedance controlled system for endometrial ablation: three-year follow-up on 107 patients. Am J Obstet Gynecol 2004;191:1585–9. 4. Hare AA, Olah KS. Pregnancy following endometrial ablation: a review article. J Obstet Gynaecol 2005;25:108–114. 5. Lo JS, Pickersgill A. Pregnancy after endometrial ablation: English literature review and case report. J Minim Invasive Gynecol 2006;13:88–91. 6. Hoffman MK, Sciscione AC. Placenta accreta and intrauterine fetal death in a woman with prior endometrial ablation: a case report. J Reprod Med 2004;49:384–6. 7. Laberge PY. Serious and deadly complications from pregnancy after endometrial ablation: two case reports and review of the literature. J Gynecol Obstet Biol Reprod (Paris) 2008;37:609–13. 8. Kerin JF, Cooper JM, Price T, Herendael BJ, Cayuela-Font E, Cher D, et al. Hysteroscopic sterilization using a micro-insert device: results of a multicentre Phase II study. Hum Reprod 2003;18:1223–30. 9. Kerin JF, Munday DN, Ritossa MG, Pesce A, Rosen D. Essure hysteroscopic sterilization: results based on utilizing a new coil catheter delivery system. J Am Assoc Gynecol Laparosc 2004;11:388–93. 10. Cooper JM, Carignan CS, Cher D, Kerin JF. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol 2003;102:59–67. 11. Hopkins MR, Creedon DJ, El-Nashar SA, Brown DL, Good AE, Famuyide AO. Radiofrequency global endometrial ablation followed by hysteroscopic sterilization. J Minim Invasive Gynecol 2007;14:494–501. 12. Donnadieu AC, Deffieux X, Gervaise A, Faivre E, Frydman R, Fernandez H. Essure sterilization associated with endometrial ablation. Int J Gynaecol Obstet 2007;97(2):139–42. 13. Thiel JA, Suchet IB, Lortie K. Confirmation of Essure microinsert tubal coil placement with conventional and volume-contrast imaging threedimensional ultrasound. Fertil Steril 2005;84:504–8. 14. Kerin JF, Carignan CS, Cher D. The safety and effectiveness of a new hysteroscopic method for permanent birth control: results of the first Essure PBC clinical study. Aust N Z J Obstet Gynaecol 2001;41:364–70. 15. Weston G, Bowditch J. Office ultrasound should be the first-line investigation for confirmation of correct ESSURE placement. Aust N Z J Obstet Gynaecol 2005;45(4):312–5. 16. Veersema S, Vleugels MP, Timmermans A, Brolmann HA. Follow-up of successful bilateral placement of Essure microinserts with ultrasound. Fertil Steril 2005;84:1733–6. 17. Thiel JA, Carson GD. Cost-effectiveness analysis comparing the Essure tubal sterilization procedure and laparoscopic tubal sterilization. J Obstet Gynaecol Can 2008;30:581–5. 18. Coad JE, Garza-Leal J, Castillo-Saenz L, Hernandez-Leon I, Livengood RH. Essure permanent birth control followed by global endometrial ablation: an in vivo peri-hysterectomy study. J Minim Invasive Gynecol 2010;17:S39–40. 19. Donnadieu AC, Fernandez H. The role of Essure sterilization performed simultaneously with endometrial ablation. Curr Opin Obstet Gynecol 2008;20:359–63.
Concomitant NovaSure Endometrial Ablation and Essure Tubal Sterilization: A Review of 100 Cases Carmen N. Mircea, MD,1 Ciaran Goojha, MD,1 John A. Thiel, MD1,2 1
Department of Obstetrics and Gynecology, University of Saskatchewan, Saskatoon SK
2
Department of Obstetrics and Gynecology, Regina Qu’Appelle Health Region, Regina SK
Abstract
Résumé
Objective: To assess the success rate, complications, and technical difficulties of concomitant NovaSure radiofrequency global endometrial ablation (NS-GEA) and Essure hysteroscopic sterilization (EHS).
Objectif : Évaluer le taux de réussite, les complications et les difficultés techniques de la tenue concomitante des interventions NovaSure radiofrequency global endometrial ablation (NS-GEA) et Essure hysteroscopic sterilization (EHS).
Methods: We conducted a retrospective descriptive study of 100 women undergoing concomitant NS-GEA and EHS for abnormal uterine bleeding. The combined procedure was completed using conscious sedation, in an outpatient setting. Patients were asked to return three months post procedure to have proper microinsert positioning confirmed by hysterosalpingogram, ultrasound, and/or pelvic radiograph.
Méthodes : Nous avons mené une étude descriptive rétrospective portant sur 100 femmes qui se soumettaient à des interventions NS-GEA et EHS concomitantes visant un saignement utérin anormal. L’intervention combinée a été menée sous sédation consciente, dans une unité de soins ambulatoires. On avait demandé aux patientes de revenir, trois mois à la suite de l’intervention, pour la tenue d’un hystérosalpingogramme, d’une échographie et/ou d’une radiographie pelvienne visant à confirmer le positionnement adéquat du micro-insert.
Results: An average of five micro-inserts were left trailing into the endometrial cavity. The mean duration of the procedure was on average 17.1 minutes. Eighty-seven patients returned for follow-up. The combined procedure was successful in 80 of these 87 patients (92%) and not successful in seven patients (8%). To improve visualization of the tubal ostia, 25 patients had suction curettage after NS-GEA, with no significant increase in the procedure time (P = 0.927). Technical difficulties included impaired visualization of the tubal ostia (7.4%), difficulty in visualizing or counting micro-inserts after placement (3.2%), and resistance to micro-insert placement (3.2%). The procedure complications were intrauterine synechiae (5.7%), endometritis (2.3%), pain that required an emergency room visit (2.3%), and migration of micro-inserts with or without perforation (4.6%). Conclusion: Concomitant NS-GEA and EHS is a safe and efficient method of providing treatment for abnormal uterine bleeding and permanent female sterilization. The combined procedure can be safely moved from the operating theatre to an outpatient setting, completely independent of anaesthesia and day surgery services. Suction curettage should be considered before EHS. A small proportion of patients may develop post-procedure intrauterine synechiae that impaired the ability to document tubal occlusion by hysterosalpingogram.
Key Words: NovaSure radiofrequency global endometrial ablation, Essure hysteroscopic sterilization, abnormal uterine bleeding, intrauterine synechia Competing Interests: See Acknowledgements. Received on November 20, 2010 Accepted on December 13, 2010
Résultats : En moyenne, cinq micro-inserts ont été laissés dans la cavité endométriale. La durée moyenne de l’intervention a été de 17,1 minutes. Quatre-vingt sept patientes se sont présentées pour le suivi. L’intervention combinée a été couronnée de succès chez 80 de ces 87 patients (92 %) et s’est soldée en échec chez sept patientes (8 %). Pour améliorer la visualisation des orifices tubaires, 25 patientes ont subi un curetage par aspiration à la suite de l’intervention NS-GEA, sans que cela n’occasionne de hausse significative de la durée d’intervention (P = 0,927). Parmi les difficultés techniques, on trouvait la difficulté de visualiser les orifices tubaires (7,4 %), la difficulté de visualiser ou de dénombrer les micro-inserts à la suite du positionnement (3,2 %) et la résistance au positionnement des micro-inserts (3,2 %). Parmi les complications de l’intervention, on trouvait les synéchies intra-utérines (5,7 %), l’endométrite (2,3 %), la douleur nécessitant une consultation en salle d’urgence (2,3 %) et la migration des micro-inserts avec ou sans perforation (4,6 %). Conclusion : La tenue concomitante des interventions NS-GEA et EHS constitue un moyen sûr et efficace d’assurer la prise en charge du saignement utérin anormal et de procéder à une stérilisation permanente. L’intervention combinée peut être menée en toute sûreté au sein d’une unité de soins ambulatoires (plutôt qu’en salle d’opération), de façon tout à fait indépendante des services d’anesthésie et de chirurgie d’un jour. La tenue d’un curetage par aspiration devrait être envisagée avant de procéder à l’intervention EHS. Une faible proportion de patientes peut en venir à voir apparaître, à la suite de l’intervention, des synéchies intra-utérines nuisant à la capacité de documenter l’occlusion tubaire par hystérosalpingogramme. J Obstet Gynaecol Can 2011;33(4):361–366
APRIL JOGC AVRIL 2011 l 361
GYNAECOLOGY
INTRODUCTION
A
bnormal uterine bleeding is a common gynaecological problem that has significant impact on a woman’s quality of life and health care costs. Traditionally, the surgical treatment for abnormal uterine bleeding has been hysterectomy.1,2 A safe and effective minimally invasive surgical alternative to hysterectomy has been found in NovaSure global endometrial ablation.3 Endometrial ablation is not a sterilizing procedure, and pregnancy after ablation may be associated with severe adverse events for the fetus and mother such as miscarriage, abnormal placentation, intrauterine growth restriction, uterine rupture or preterm birth.4–7 Reliable contraception or permanent sterilization should therefore be offered to women of childbearing age undergoing the procedure. Since both GEA and Essure hysteroscopic tubal sterilization have been independently proven to be safe and efficient in controlling bleeding and providing reliable contraception, respectively, combining these two methods is an ideal solution.3,8–10 Moreover, the cost-effectiveness of combining these two procedures may be significant. Indeed, performing concomitant NS-GEA and EHS has been shown to be effective management for women with abnormal uterine bleeding requiring postNS-GEA permanent sterilization.11,12 However, previous studies have been based on small numbers of patients. There are no current restrictions in Canada regarding the performance of concomitant global ablation and Essure micro-insert placement. Because we are able to use ultrasound as a follow-up to assess micro-insert position,13 the potential for difficulty in interpreting the post-insertion hysterosalpingogram is not a concern. In the present study, we describe our five-year experience of performing 100 concomitant NS-GEA and EHS procedures, 98 of which were performed in an outpatient, ambulatory setting. This is the first study to describe the feasibility of concomitant NS-GEA and EHS procedure in an outpatient, ambulatory setting, completely independent from the operating room and anaesthesia services. MATERIALS AND METHODS
We conducted a retrospective descriptive study of 100 women who were scheduled to have concomitant NS-GEA and EHS performed between July 2004 and September ABBREVIATIONS EHS
Essure hysteroscopic tubal sterilization
GEA
global endometrial ablation
NS-GEA NovaSure global endometrial ablation
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2009. These women were referred to our clinic because of abnormal uterine bleeding. They were evaluated by one physician (J.A.T.) and management options were discussed. Patients elected to undergo NS-GEA and therefore required proper counselling regarding a permanent and reliable contraception method. After discussion of the options for permanent contraception, the patients opted to undergo EHS. Full investigation of the abnormal uterine bleeding (including endometrial biopsy and pelvic ultrasound) was carried out to rule out contraindications to either NS-GEA or EHS. Informed consent was obtained from all patients. Procedures were performed at various times in the menstrual cycle. No routine pre-treatment of the endometrium was carried out. Most of the patients underwent the concomitant procedures in the Women’s Heath Centre, an outpatient department at the Regina General Hospital, not in the operating room, and did not require monitored anaesthesia care. Only two cases were carried out in the operating room. Specialized nursing staff received the patients and explained the procedure. The analgesia consisted of a combination of intravenous midazolam (1 to 2 mg) and fentanyl (2 μg/kg), and doses were titrated according to the patient’s level of discomfort. The clinical status of patients (blood pressure, heart rate, and oxygen saturation) was closely monitored by the bedside nurse, and additional analgesia and/or sedation was given if necessary. Paracervical nerve block was induced using lidocaine 1%. Hysteroscopy was initially performed using a 5.5 mm single channel continuous flow hysteroscope and a 2.7 mm lens (Circon AMCI, Toronto, ON) and using normal saline as the distension medium. The tubal ostia were identified and, after appropriate dilatation of the cervix, NS-GEA was performed. Twenty-five patients had suction curettage with no.8 suction curette after endometrial ablation in order to improve visualization of the tubal ostia. The hysteroscope was reinserted and, after inspection of the uterine cavity and localization of the tubal ostia, Essure micro-inserts were placed according to the manufacturer’s guidelines. After completion of the procedure, patients were transferred to the recovery area. Oral analgesia and antiemetic medication were provided as needed. We used single drug analgesia or combinations of ibuprofen, acetaminophen, acetaminophen with codeine, and promethazine. Patients were discharged from the ambulatory setting on the same day after the effects of conscious sedation had passed and patients were stable and comfortable.
Concomitant NovaSure Endometrial Ablation and Essure Tubal Sterilization: A Review of 100 Cases
Flow of study participants
Patients were instructed to use a reliable contraceptive method for three months after the procedure, and office staff arranged appointments for the three-month followup to confirm correct placement of the micro-inserts using hysterosalpingography, conventional and/or 3-D ultrasound, or pelvic X-ray.13–16 The results of these investigations were reviewed by a radiologist, and the position of the micro-inserts was deemed to be appropriate, not appropriate, or unsure. In case of uncertainty, a second confirmatory test (hysterosalpingogram or ultrasound) was performed. All data were collected by retrospective chart review. The population’s demographics, the time and details of the procedure, and medication dosage were characterized using descriptive statistics. Mann-Whitney test was used
to assess the time difference between procedures in which suction curettage was performed and those in which it was not performed. Ethics approval for the study was provided by the Ethics Review Board of Regina Qu’Appelle Health Region. RESULTS
The study flow chart is shown in the Figure. Six patients were excluded from the analysis because follow-up medical records could not be retrieved. The remaining 94 patients included in the study had a mean age of 39.5 ± 4.8 years (95% CI 38.5 to 40.5). The median parity was 2 (range 0 to 5), and mean body mass index was 29.2 ± 7.1 kg/m² (95% CI 27.7 to 30.7). APRIL JOGC AVRIL 2011 l 363
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Procedure time, NovaSure and Essure parameters Mean, SD (95% CI) Mean total procedure time (95% CI), min
17.1 ± 5.9 (15.9 to 18.3)
NovaSure ablation, cm Mean cavity length (95% CI)
5.2 ± 0.4 (5.1 to 5.3)
Mean cavity width (95% CI)
3.7 ± 0.7 (3.5 to 3.8)
Essure micro-inserts, n Mean, Micro-inserts on left side (95% CI)
4.5 ± 2.2 (4.0 to 4.9)
Mean, Micro-inserts on right side (95% CI)
4.9 ± 3.0 (4.3 to 5.5)
Conscious sedation was used in 92 of 94 patients (98%); two patients (2 %) had the procedure performed in the operating room under general anaesthesia. Intravenous midazolam and fentanyl was used for 87% of patients (81/93). In 11% of patients (10/93), a combination of diazepam and fentanyl was used for analgesia. The mean doses of IV midazolam, fentanyl, and diazepam were 1.2 ± 0.6 mg (95% CI 1.1 to 1.3), 168.5 ± 44.5 μg (95% CI 159.2 to 177.9), and 3.2 ± 1.2 mg (95% CI 2.4 to 4.1), respectively. Technical difficulties occurred in 14.9% of patients (14/94) during the procedure and consisted of impaired visualization of the tubal ostia (7/94; 7.4%), difficulty in visualizing and counting micro-inserts after placement (3/94; 3.2%), or resistance to micro-insert placement (3/94; 3.2%). In one case (1.1%) the Essure procedure could not be completed because of patient discomfort. Since only endometrial ablation was performed, and not concomitant NS-GEA and EHS, this case was removed from analysis and the remaining 93 patients were further analyzed (Figure). Total procedure time and procedure variables are summarized in the Table. Twenty-five of the 93 patients (27%) had suction curettage performed after NS-GEA to improve visualization of the tubal ostia. No significant increase in the duration of the procedure was noted in the patients who had suction curettage performed (16 minutes; range 10 to 33) compared with the non-suction curettage group (15 minutes; range 7 to 36) (P = 0.927). Post-procedure analgesia consisted of acetaminophen 650 mg (in 18.4% of patients), ibuprofen 400 mg (28.2%), oral combinations of acetaminophen and ibuprofen (32.6%), or acetaminophen with codeine and ibuprofen (2.2%). Seven patients (7.7%) received various combinations of acetaminophen, ibuprofen, promethazine, and acetaminophen with codeine. No post-procedure analgesia was required in 10.9% of patients. Eighty-seven of the 93 patients (93.5%) presented for the three-month confirmation follow-up of the Essure 364 l APRIL JOGC AVRIL 2011
micro-insert placement. Five (5.4%) patients failed to return for the follow-up, while one patient (1.1%) underwent hysterectomy before the time of the follow-up and thus did not require imaging. This patient requested total laparoscopic hysterectomy for chronic pelvic pain secondary to endometriosis. Essure micro-inserts were found to be properly positioned on assessment of the gross pathology of the specimen. During follow-up, bilateral tubal occlusion and/or proper micro-insert positioning was demonstrated in 80 of the returning 87 patients (92%) through hysterosalpingography, pelvic ultrasound and/or pelvic X-ray. The criteria for proper positioning of Essure micro-inserts were not met in the remaining seven patients (8.0%). Six patients (6.9%) showed unilateral tubal occlusion only, and in one case (1.1%) both micro-inserts were displaced into the uterine cavity. Only one of the 25 patients who had suction curettage after NS-GEA had improper micro-insert positioning. Six of the seven patients with a failed procedure, (85.7%) did not have suction curettage performed after NS-GEA. Proper micro-insert placement was documented by hysterosalpingography (21/80; 26.3%), ultrasound (56/80; 70%), or pelvic X-ray (3/80; 3.7%). When the ultrasound was not conclusive, hysterosalpingography was also performed for definitive confirmation. If hysterosalpingography was the initial confirmation test and showed inconclusive findings, ultrasound was performed. The three cases in which pelvic X-ray was used as the only follow-up test were the earliest cases in the study; at that time, pelvic X-ray was thought to provide sufficient evidence for confirmation of proper micro-insert placement. Intrauterine synechiae (5/87; 5.7%), endometritis (2/87; 2.3%), pain that required an emergency room visit (2/87; 2.3%), and migration of micro-inserts with or without perforation (4/87; 4.6%) were the short and long-term procedure complications. The uterine cavity after NS-GEA was not occluded in most cases in which hysterosalpingography was performed (16/21; 76.2%).
Concomitant NovaSure Endometrial Ablation and Essure Tubal Sterilization: A Review of 100 Cases
DISCUSSION
This is the first study to clearly show the feasibility, efficacy, and safety of moving this procedure from the operating theatre to an outpatient, ambulatory setting, completely independent from day surgery and anaesthesia services. Previously published studies have proven that performing the Essure procedure in an ambulatory setting results in a statistically significant cost saving when compared with traditional laparoscopic tubal sterilization performed in the operating room.17 Thus, we would expect to find similar savings when comparing the combined procedure performed in an outpatient, ambulatory setting with the combined procedure performed in the operating theatre. The device costs were covered for all patients by their provincial health care insurance. Our results agree with previously published studies reporting that concomitant NS-GEA and EHS is a generally safe, fast, and efficient method of providing both treatment for abnormal uterine bleeding and permanent female sterilization.11,12 Furthermore, recent data have shown that placement of Essure micro-inserts does not alter the ability to perform subsequent NovaSure ablation, supporting acceptable safety profiles for NovaSure following Essure placement.18 Unlike previously published studies,11,12 our study assesses the success rate, complications and technical difficulties of concomitant NS-GEA and EHS in a much larger cohort of patients. We also report a shorter total procedure time of 17.1 ± 5.9 min (95% CI 15.9 to 18.3) (Table). Patients tolerated the combined procedure well with IV conscious sedation and post-procedure oral analgesia. Only one patient was too uncomfortable after the NS-GEA to allow subsequent EHS. Although this patient ultimately did not have the combined procedure, we opted to keep this case in our study to illustrate that the inability to perform EHS after NS-GEA because of the patient’s discomfort is a rare but possible outcome. Uterine curettage and evacuation before endometrial ablation have been reported to improve post-ablation visualization of tubal ostia.11 A subgroup of patients in our study had suction curettage after the NS-GEA, and this procedure did not significantly alter the procedure time. Therefore, in order to decrease the amount of postablation intrauterine debris, suction curettage should be considered before tubal sterilization. We encountered the following three types of technical difficulties in our study. Because these technical difficulties
do not commonly occur when the procedures are performed individually, they are likely the result of combining the two procedures. 1. Impaired tubal visualization. This was the most common technical difficulty encountered in our study and was also reported by previous studies.11,12 Although we were still able to cannulate tubal ostia in most patients in whom tubal visualization was impaired, we observed that two of these patients were among the seven cases with failed tubal sterilization. One of these two patients was also found to have a bicornuate uterus, and this might have added to the technical challenge of the combined procedure. 2. Impaired visualization and/or impaired counting of the number of intrauterine Essure micro-inserts placed. This was due to the uterine debris resulting from the endometrial ablation. This occurred in three cases, but in all three bilateral proper micro-insert placement was confirmed at the three-month follow-up. 3. Resistance met at micro-insert placement. This could have been related to tubal spasm or previous tubal scarring. In all three patients in whom this problem occurred, the confirmatory test showed proper microinsert placement at three months post procedure. The last two of these technical difficulties encountered during combined NS-GEA and EHS have not previously been reported, most likely because of the small number of cases analyzed in prior studies. Seven patients did not meet the criteria for proper positioning of micro-inserts or bilateral tubal occlusion. The patient who was shown to have a bicornuate uterus and who had technical difficulties at the time of the procedure also developed bilateral displacement of microinserts in the uterine cavity. This suggests that patients with an identified uterine anomaly might not be ideal candidates for a combined NS-GEA and EHS procedure, already described as more technically challenging.11,19 Another patient with failed proper micro-insert positioning was among the cases in whom we encountered poor visualization of the ostia during the procedure. In one case we were not able to cannulate one ostium. In the remaining four cases, no obvious technical difficulties or complications were documented; this might also be explained by the reported increase in the difficulty of the combined procedures,11,19 especially related to poor visualization of the ostia. A previous study,11 however did not report that poor visualization of the ostia after
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endometrial ablation interfered with the success rate of the combined procedure. This difference might be explained by the smaller number of patients studied. All patients with failed micro-insert placement or tubal occlusion underwent subsequent laparoscopic tubal ligation or successfully repeated EHS. Intrauterine synechiae, endometritis, pain requiring a visit to the emergency room, and micro-insert migration and/ or perforation were the short- and long-term postoperative complications observed in this study. The formation of intrauterine synechiae was found to be the most common post-procedure complication. Also described in prior studies, this problem was not previously observed to interfere with determining the location of micro-inserts or occlusion of tubes.11 This was not the case in our study, considering that in three out of the five patients diagnosed with uterine synechiae, the hysterosalpingogram failed to demonstrate tubal occlusion because of an inability to cannulate or properly fill the uterine cavity with contrast substance. However, we were able to confirm the proper placement of the device in these cases by ultrasound. Other complications included significant pain requiring a visit to the emergency room (two patients) or infection (two patients), suggesting a possible beneficial role of post-procedure prophylactic antibiotics. This subject is still controversial, and there is no evidence for or against the routine use of antibiotics.19 We did not administer antibiotics in this study. However, other authors reported routine prophylactic use of antibiotic.19 Three of the four patients found to have micro-insert migration/perforation at the three-month follow-up test were determined to have bilateral tubal occlusion on hysterosalpingography. Therefore, micro-insert migration does not necessarily imply tubal patency. CONCLUSION
This study concludes that concomitant NS-GEA and ESH is a safe, fast, and efficient method of providing treatment for abnormal uterine bleeding and permanent female sterilization in an outpatient setting, completely independent of anaesthesia and day surgery services. Difficulty in visualizing the tubal ostia after the NS-GEA was the most common technical challenge encountered and might have interfered with proper visualization and placement of Essure devices. Suction curettage improved visualization of the ostia after GEA and did not significantly alter the procedure time; it should therefore be considered before performing tubal sterilization. A small proportion of patients developed post-procedure intrauterine synechiae that impaired the ability to document tubal occlusion by hysterosalpingography, but not by ultrasound. 366 l APRIL JOGC AVRIL 2011
ACKNOWLEDGEMENTS
Dr Thiel is a consultant with Conceptus, Inc. REFERENCES 1. Duckitt K. Managing perimenopausal menorrhagia. Maturitas 2010;66:251–6. 2. Coulter A, Peto V, Jenkinson C. Quality of life and patient satisfaction following treatment for menorrhagia. Fam Pract 1994;11:394–401. 3. Gallinat A. NovaSure impedance controlled system for endometrial ablation: three-year follow-up on 107 patients. Am J Obstet Gynecol 2004;191:1585–9. 4. Hare AA, Olah KS. Pregnancy following endometrial ablation: a review article. J Obstet Gynaecol 2005;25:108–114. 5. Lo JS, Pickersgill A. Pregnancy after endometrial ablation: English literature review and case report. J Minim Invasive Gynecol 2006;13:88–91. 6. Hoffman MK, Sciscione AC. Placenta accreta and intrauterine fetal death in a woman with prior endometrial ablation: a case report. J Reprod Med 2004;49:384–6. 7. Laberge PY. Serious and deadly complications from pregnancy after endometrial ablation: two case reports and review of the literature. J Gynecol Obstet Biol Reprod (Paris) 2008;37:609–13. 8. Kerin JF, Cooper JM, Price T, Herendael BJ, Cayuela-Font E, Cher D, et al. Hysteroscopic sterilization using a micro-insert device: results of a multicentre Phase II study. Hum Reprod 2003;18:1223–30. 9. Kerin JF, Munday DN, Ritossa MG, Pesce A, Rosen D. Essure hysteroscopic sterilization: results based on utilizing a new coil catheter delivery system. J Am Assoc Gynecol Laparosc 2004;11:388–93. 10. Cooper JM, Carignan CS, Cher D, Kerin JF. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol 2003;102:59–67. 11. Hopkins MR, Creedon DJ, El-Nashar SA, Brown DL, Good AE, Famuyide AO. Radiofrequency global endometrial ablation followed by hysteroscopic sterilization. J Minim Invasive Gynecol 2007;14:494–501. 12. Donnadieu AC, Deffieux X, Gervaise A, Faivre E, Frydman R, Fernandez H. Essure sterilization associated with endometrial ablation. Int J Gynaecol Obstet 2007;97(2):139–42. 13. Thiel JA, Suchet IB, Lortie K. Confirmation of Essure microinsert tubal coil placement with conventional and volume-contrast imaging threedimensional ultrasound. Fertil Steril 2005;84:504–8. 14. Kerin JF, Carignan CS, Cher D. The safety and effectiveness of a new hysteroscopic method for permanent birth control: results of the first Essure PBC clinical study. Aust N Z J Obstet Gynaecol 2001;41:364–70. 15. Weston G, Bowditch J. Office ultrasound should be the first-line investigation for confirmation of correct ESSURE placement. Aust N Z J Obstet Gynaecol 2005;45(4):312–5. 16. Veersema S, Vleugels MP, Timmermans A, Brolmann HA. Follow-up of successful bilateral placement of Essure microinserts with ultrasound. Fertil Steril 2005;84:1733–6. 17. Thiel JA, Carson GD. Cost-effectiveness analysis comparing the Essure tubal sterilization procedure and laparoscopic tubal sterilization. J Obstet Gynaecol Can 2008;30:581–5. 18. Coad JE, Garza-Leal J, Castillo-Saenz L, Hernandez-Leon I, Livengood RH. Essure permanent birth control followed by global endometrial ablation: an in vivo peri-hysterectomy study. J Minim Invasive Gynecol 2010;17:S39–40. 19. Donnadieu AC, Fernandez H. The role of Essure sterilization performed simultaneously with endometrial ablation. Curr Opin Obstet Gynecol 2008;20:359–63.