Letters to the Editor Hysteroscopic Endometrial Resection Versus Laparoscopic Supracervical Hysterectomy for Abnormal Uterine Bleeding: Long-Term Follow-Up of a Randomized Trial To the Editor: The article by Zupi et al [1] is important, because longterm follow-up is critical to accurately evaluate the success of surgical procedures. The authors studied outcomes of hysteroscopic endometrial ablation (HEA) compared with laparoscopic supracervical hysterectomy (LSH) over a 14.4-year period (173 7.2 months) for the treatment of abnormal uterine bleeding (AUB). They concluded that based on improved quality of life and a lower reoperative rate, LSH should be considered the treatment of choice in women with AUB resistant to medical treatment and should be proposed to all women in place of hysteroscopic endometrial ablation (HEA). Reoperative rates in the LSH group were 6% (5 of 82) for an indication of chronic pelvic pain. No patient required repeat surgery for AUB. In the HEA group, the reoperative rate was 28% (20 of 71). The indication was persistent bleeding in 40% (8 of 20). Despite a second hysteroscopic surgery, 75% (15 of 20) underwent hysterectomy for relapse of symptoms. Unfortunately, the patient symptoms and surgical indications were not specified. We would like to ask the authors what percentage of patients in the HEA group had pain as an indication for reoperation. Longinotti et al [2] published an important study on the probability of hysterectomy after endometrial ablation. They studied 3681 patients who had undergone either resectoscopic endometrial ablation (REA) or nonresectoscopic endometrial ablation (NREA) for intractable AUB, and found that 21% eventually had undergone hysterectomy, and that this rate continued to increase throughout the 8-year follow-up. The failure rates were similar for the resectoscopic and global ablation techniques. The main indications for hysterectomy were bleeding (51.6%), pain (22%), and bleeding with pain in (20.3%); therefore, 42.3% of patients had a pain component as an indication for hysterectomy. Vilos et al [3] reported 163 hysterectomies after REA. The indication was intractable bleeding alone in 12.3%, intractable bleeding and pain in 23.3%, and cyclic pelvic pain in 64.4%. It is now evident that new-onset postablation cyclic pain is usually related to obstructed bleeding. Persistent or 1553-4650/$ - see front matter Ó 2016 AAGL. All rights reserved.
regenerating endometrium trapped behind postablation intrauterine scarring can bleed, which causes painful central hematometra, cornual hematometra, and/or hematosalpinx (postablation tubal sterilization syndrome). These longterm complications are often underreported. If the imaging study or hysterectomy is not performed when the patient is symptomatic, during the menstrual phase of her cycle, the blood can absorb and the diagnosis can be missed. In addition, a significant, rarely emphasized clinical post-HEA problem is the fact that postablation scarring can make it difficult or nearly impossible to thoroughly evaluate the intrauterine cavity when patients return with an abnormal imaging study, AUB, or pain. Endometrial biopsy, hydrosonography, and diagnostic hysteroscopy are often unreliable [4]. A hysterectomy may be necessary to resolve this diagnostic dilemma. The aforementioned delayed complications have been thoroughly discussed and documented in previous review articles [5–8]. The partial endometrial ablation or resection (PEA) technique was specifically developed to avoid these delayed complications. A modification of total/global endometrial ablation, PEA is defined as ablation or resection of only the anterior or posterior endometrial wall, with the cornual areas avoided. When only 1 wall is injured, it heals in juxtaposition to an uninjured endometrial surface on the opposite wall. Consequently, the injured and uninjured surfaces do not grow together, and intrauterine contracture and scarring do not occur. Painful obstructed bleeding problems are avoided, and the uterine cavity remains open for easy future access and evaluation. The goal of partial endometrial ablation or resection is to create hypomenorrhea or eumenorrhea, not amenorrhea, and prevent long-term complications. The original article describing PEA was published in 1999 [9]. Fifty patients who underwent partial rollerball endometrial ablation for intractable uterine bleeding were studied for 3 years, with a patient satisfaction rate of 76%. The intrauterine cavity was evaluated in 38 patients (76%), and no scarring or contracture was observed. The tubal ostia could be visualized bilaterally in these patients. No newonset cyclic pelvic pain occurred. Hysterectomies were necessary in 10% because of persistent or recurrent bleeding, and deep adenomyosis was found in all specimens [9]. Litta et al [10] performed a partial endometrial resection and coined the term ‘‘modified transcervical endometrial resection’’ (MTCER). They followed 73 patients for 5 years. Patient satisfaction was 87%, and no painful obstructive
Letters to the Editor
137
problems occurred. A diagnostic hysteroscopy was performed on all patients at 5 years. The cavity was found to be open, and both tubal ostia could be visualized. The authors concluded that MTCER can successfully treat menorrhagia without causing intrauterine scarring, thereby avoiding long-term complications [10]. We are currently completing a long-term follow-up of patients who underwent PEA. Questionnaires have been sent to 247 patients who underwent partial rollerball endometrial ablation between 1991 and 2003. Preliminary results are encouraging. The mean follow-up is 17.5 years, with a patient satisfaction rate of 89%. No patient developed new-onset cyclic pelvic pain. Hysterectomy was required for recurrent AUB in 8%, and all were found to have deep adenomyosis. This confirms Zupi et al’s suggestion that when deep adenomyosis is strongly suspected in preoperative imaging studies, a hysterectomy should be recommended over any type of ablation. In conclusion, we agree with Zupi et al that the lower reintervention rate and the better physical and mental health scores make LSH a more suitable procedure than HEA for treating AUB that is resistant to medical therapy. However, if future studies confirm that PEA provides successful treatment of intractable AUB without long-term complications, it would be a less-invasive procedure than hysterectomy for the treatment of intractable AUB. Arthur M. McCausland, MD Vance M. McCausland, MD Sacramento, CA References 1. Zupi E, Centinti G, Lazzeri L, Finco A, Exacoustos C, Afors K, et al. Hysteroscopic endometrial resection versus laparoscopic supracervical hysterectomy for abnormal uterine bleeding: longterm follow-up of a randomized trial. J Minim Invasive Gynecol 2015;22:841–5. 2. Longinotti MK, Jacobson GF, Hung YY, Learman LA. Probability of hysterectomy after endometrial ablation. Obstet Gynecol 2008;112:1214–20. 3. Vilos GA, Abu-Rafea B, Etler HC, Ahmand R. Indications for hysterectomy and uterine histopathology following hysteroscopic endometrial ablation. J Minim Invasive Gynecol 2005;12:9. 4. Ahonkallio SJ, Liakka AK, Martinkainen HK. Feasibility of endometrial assessment after thermal ablation. Eur J Obstet Gynecol Biol 2009;147:69–71. 5. McCausland AM, McCausland VM. Long-term complications of endometrial ablation. J Minim Invasive Gynecol 2007;14:399–406. 6. McCausland AM, McCausland VM. Long-term complications of minimally invasive endometrial ablation devices. J Gynecol Surg 2010;26:133–49. 7. Sharp HT. Endometrial ablation: postoperative complications. Am J Obstet Gynecol 2012;207:242–7. 8. Wortman M, Cholkeri A, McCausland AM, McCausland VM. Lateonset endometrial ablation failure: etiology, treatment, and prevention. J Minim Invasive Gynecol 2015;3:323–31. 9. McCausland AM, McCausland VM. Partial rollerball endometrial ablation: a modification of total ablation to treat menorrhagia without causing complications from intrauterine adhesions. Am J Obstet Gynecol 1999;180:1512–21.
10. Litta P, Nappi L, Flori P, Mencagalia L, Franchini M, Angioni S. Proposal of a modified transcervical endometrial resection (TCER) technique for menorrhagia treatment: feasibility, efficacy, and patient’s acceptability. Gynecol Surg 2014;11:165–71. http://dx.doi.org/10.1016/j.jmig.2015.08.005
Hysteroscopic Essure Inserts for Permanent Contraception: Extended Follow-Up Results of a Phase III Multicenter International Study To the Editor: We read the article by Drs. Chudnoff, Nichols, and Levie [1] with great interest and applaud their publication of Phase III data on 5-year follow-up after hysteroscopic sterilization. However, we are concerned about their focus on perfect use rather than real-world use. Specifically, their evaluation of effectiveness was based on ‘‘women with successful bilateral placement of Essure inserts,’’ rather than women who attempted Essure. For example, the study excluded 4 women who became pregnant before undergoing hysterosalpingography (HSG), 15 women who underwent hysterectomy, 1 woman who missed her 6-month follow-up HSG, 1 woman who was incarcerated, 1 woman who had unsatisfactory device placement, and 1 woman with leukemia from the intention-to-treat analysis. Removing these participants from the study’s denominator makes the proportion of successful procedures appear higher than it actually is. In addition, 30% of enrolled women did not complete the 5-year follow-up, and these women may have had more problems than the women who completed follow-up. We agree with the authors’ hypothesis that some women might not consider laparoscopic sterilization owing to the need to undergo the procedure in the operating room, receive general anesthesia, or miss work. Yet the authors do not report how many of the procedures they studied were done in the office versus the operating room, information on anesthesia used, or days of missed work. Although we appreciate the authors’ reference to our previous publications on the topic, we feel that our results were misrepresented, perhaps because of a misunderstanding of our methodology [2,3]. Our Markov models incorporated all relevant data available in the published literature, including data from the manufacturer of Essure. We also performed extensive sensitivity analyses in both studies to assess the impact on our findings when varying the value of key variables over plausible ranges, rather than relying on single parameter assumptions. Moreover, we disagree with the authors’ statement that our models ‘‘accentuate poor HSG follow-up with hysteroscopic sterilization’’ [1]. Based on published data available at the time of publication on the proportion of women completing HSG follow-up while considering the study size, to ensure that findings from a small study do not ‘‘count’’ as much as
regenerating endometrium trapped behind postablation intrauterine scarring can bleed, which causes painful central hematometra, cornual hematometra, and/or hematosalpinx (postablation tubal sterilization syndrome). These longterm complications are often underreported. If the imaging study or hysterectomy is not performed when the patient is symptomatic, during the menstrual phase of her cycle, the blood can absorb and the diagnosis can be missed. In addition, a significant, rarely emphasized clinical post-HEA problem is the fact that postablation scarring can make it difficult or nearly impossible to thoroughly evaluate the intrauterine cavity when patients return with an abnormal imaging study, AUB, or pain. Endometrial biopsy, hydrosonography, and diagnostic hysteroscopy are often unreliable [4]. A hysterectomy may be necessary to resolve this diagnostic dilemma. The aforementioned delayed complications have been thoroughly discussed and documented in previous review articles [5–8]. The partial endometrial ablation or resection (PEA) technique was specifically developed to avoid these delayed complications. A modification of total/global endometrial ablation, PEA is defined as ablation or resection of only the anterior or posterior endometrial wall, with the cornual areas avoided. When only 1 wall is injured, it heals in juxtaposition to an uninjured endometrial surface on the opposite wall. Consequently, the injured and uninjured surfaces do not grow together, and intrauterine contracture and scarring do not occur. Painful obstructed bleeding problems are avoided, and the uterine cavity remains open for easy future access and evaluation. The goal of partial endometrial ablation or resection is to create hypomenorrhea or eumenorrhea, not amenorrhea, and prevent long-term complications. The original article describing PEA was published in 1999 [9]. Fifty patients who underwent partial rollerball endometrial ablation for intractable uterine bleeding were studied for 3 years, with a patient satisfaction rate of 76%. The intrauterine cavity was evaluated in 38 patients (76%), and no scarring or contracture was observed. The tubal ostia could be visualized bilaterally in these patients. No newonset cyclic pelvic pain occurred. Hysterectomies were necessary in 10% because of persistent or recurrent bleeding, and deep adenomyosis was found in all specimens [9]. Litta et al [10] performed a partial endometrial resection and coined the term ‘‘modified transcervical endometrial resection’’ (MTCER). They followed 73 patients for 5 years. Patient satisfaction was 87%, and no painful obstructive
Letters to the Editor
137
problems occurred. A diagnostic hysteroscopy was performed on all patients at 5 years. The cavity was found to be open, and both tubal ostia could be visualized. The authors concluded that MTCER can successfully treat menorrhagia without causing intrauterine scarring, thereby avoiding long-term complications [10]. We are currently completing a long-term follow-up of patients who underwent PEA. Questionnaires have been sent to 247 patients who underwent partial rollerball endometrial ablation between 1991 and 2003. Preliminary results are encouraging. The mean follow-up is 17.5 years, with a patient satisfaction rate of 89%. No patient developed new-onset cyclic pelvic pain. Hysterectomy was required for recurrent AUB in 8%, and all were found to have deep adenomyosis. This confirms Zupi et al’s suggestion that when deep adenomyosis is strongly suspected in preoperative imaging studies, a hysterectomy should be recommended over any type of ablation. In conclusion, we agree with Zupi et al that the lower reintervention rate and the better physical and mental health scores make LSH a more suitable procedure than HEA for treating AUB that is resistant to medical therapy. However, if future studies confirm that PEA provides successful treatment of intractable AUB without long-term complications, it would be a less-invasive procedure than hysterectomy for the treatment of intractable AUB. Arthur M. McCausland, MD Vance M. McCausland, MD Sacramento, CA References 1. Zupi E, Centinti G, Lazzeri L, Finco A, Exacoustos C, Afors K, et al. Hysteroscopic endometrial resection versus laparoscopic supracervical hysterectomy for abnormal uterine bleeding: longterm follow-up of a randomized trial. J Minim Invasive Gynecol 2015;22:841–5. 2. Longinotti MK, Jacobson GF, Hung YY, Learman LA. Probability of hysterectomy after endometrial ablation. Obstet Gynecol 2008;112:1214–20. 3. Vilos GA, Abu-Rafea B, Etler HC, Ahmand R. Indications for hysterectomy and uterine histopathology following hysteroscopic endometrial ablation. J Minim Invasive Gynecol 2005;12:9. 4. Ahonkallio SJ, Liakka AK, Martinkainen HK. Feasibility of endometrial assessment after thermal ablation. Eur J Obstet Gynecol Biol 2009;147:69–71. 5. McCausland AM, McCausland VM. Long-term complications of endometrial ablation. J Minim Invasive Gynecol 2007;14:399–406. 6. McCausland AM, McCausland VM. Long-term complications of minimally invasive endometrial ablation devices. J Gynecol Surg 2010;26:133–49. 7. Sharp HT. Endometrial ablation: postoperative complications. Am J Obstet Gynecol 2012;207:242–7. 8. Wortman M, Cholkeri A, McCausland AM, McCausland VM. Lateonset endometrial ablation failure: etiology, treatment, and prevention. J Minim Invasive Gynecol 2015;3:323–31. 9. McCausland AM, McCausland VM. Partial rollerball endometrial ablation: a modification of total ablation to treat menorrhagia without causing complications from intrauterine adhesions. Am J Obstet Gynecol 1999;180:1512–21.
10. Litta P, Nappi L, Flori P, Mencagalia L, Franchini M, Angioni S. Proposal of a modified transcervical endometrial resection (TCER) technique for menorrhagia treatment: feasibility, efficacy, and patient’s acceptability. Gynecol Surg 2014;11:165–71. http://dx.doi.org/10.1016/j.jmig.2015.08.005
Hysteroscopic Essure Inserts for Permanent Contraception: Extended Follow-Up Results of a Phase III Multicenter International Study To the Editor: We read the article by Drs. Chudnoff, Nichols, and Levie [1] with great interest and applaud their publication of Phase III data on 5-year follow-up after hysteroscopic sterilization. However, we are concerned about their focus on perfect use rather than real-world use. Specifically, their evaluation of effectiveness was based on ‘‘women with successful bilateral placement of Essure inserts,’’ rather than women who attempted Essure. For example, the study excluded 4 women who became pregnant before undergoing hysterosalpingography (HSG), 15 women who underwent hysterectomy, 1 woman who missed her 6-month follow-up HSG, 1 woman who was incarcerated, 1 woman who had unsatisfactory device placement, and 1 woman with leukemia from the intention-to-treat analysis. Removing these participants from the study’s denominator makes the proportion of successful procedures appear higher than it actually is. In addition, 30% of enrolled women did not complete the 5-year follow-up, and these women may have had more problems than the women who completed follow-up. We agree with the authors’ hypothesis that some women might not consider laparoscopic sterilization owing to the need to undergo the procedure in the operating room, receive general anesthesia, or miss work. Yet the authors do not report how many of the procedures they studied were done in the office versus the operating room, information on anesthesia used, or days of missed work. Although we appreciate the authors’ reference to our previous publications on the topic, we feel that our results were misrepresented, perhaps because of a misunderstanding of our methodology [2,3]. Our Markov models incorporated all relevant data available in the published literature, including data from the manufacturer of Essure. We also performed extensive sensitivity analyses in both studies to assess the impact on our findings when varying the value of key variables over plausible ranges, rather than relying on single parameter assumptions. Moreover, we disagree with the authors’ statement that our models ‘‘accentuate poor HSG follow-up with hysteroscopic sterilization’’ [1]. Based on published data available at the time of publication on the proportion of women completing HSG follow-up while considering the study size, to ensure that findings from a small study do not ‘‘count’’ as much as
