Abstract
Abstract
Introduction
T
In an attempt to prevent these delayed complications, the current total or global ablation technique was modified to a partial ablation technique (PEA) in hopes of treating HMB successfully without causing intrauterine scarring. PEA is defined as ablating or resecting only the anterior or posterior endometrial wall.
The original study results on partial endometrial ablation were encouraging with a 3-year follow-up. 4 The present study is a longer-term evaluation on outcome of PEA.
Materials and Methods
The institutional research committee approved this study (#100602ex) on November 8, 2010. Following approval, 269 patients, ≥55 years of age, who underwent PEA from 1990 to 2003, were identified via electronic medical record Current Procedural Terminology codes. Health Insurance Portability and Accountability Act release forms, informed consent, and study questionnaires were mailed to these patients to collect study data. Via the questionnaire, the researchers asked patients to compare their pain and bleeding before and after undergoing PEA. In addition, a validated quality of life (QoL) questionnaire (Menorrhagia Multi-attribute Utility [MMU] scale) was included.5,6 Using this scale, a lower score indicated a higher QoL.
The amount of bleeding was quantified by clot size. Clot size is not as precise as quantifying actual blood loss, but this size reflects enough bleeding to overwhelm the plasminogen and other anticoagulant factors in the endometrium. Patients were asked to state if their clots were the size of a dime, quarter, half-dollar, silver dollar, or larger. Pain was measured by asking patients whether or not they had significant menstrual cramps (dysmenorrhea). Patients were asked to compare their pain before and after they had surgery, rate whether or not the pain was lessened, stayed the same, or worsened, and whether or not they required additional surgery.
A decrease in bleeding or pain was scored as −1, no change scored as 0, and an increase in bleeding or pain was scored as +1. The Test of Independent Proportions was used to compare the proportion of patients who had a decrease in pain or bleeding versus no change or increase in pain. The MMU was used to ask patients six questions regarding how their everyday lives were impacted by their condition both before and after PEA.5,6 Each question was scored 1 (little to no impact) to 4 (severe impact). Scores were summed over all questions. (Appendix A) Differences in mean MMU scores before and after ablation were analyzed using a paired t-test.
Initially, 269 questionnaires were mailed yielding 43 responses. A second mailing to 172 patients returned 20 responses. A final mailing to 139 patients that included a $5 gift card yielded an additional 7 responses. Incomplete medical records and/or questionnaires as well as study exclusions reduced the total study patient number further to 39.
Inclusion criteria were:
1. Patients who had a PEA from April 1990 to June 2003 for AUB. 2. Under the age 55 at the time of the PEA. 3. Normal intrauterine cavity with or without gross endometrial polyps.
Exclusion criteria were:
1. Age 55 or older. 2. Presence of submucous myoma(s), atypical hyperplasia or cancer identified on hysteroscopy.
Patient charts were obtained to confirm study candidacy. Data for pre- and post-PEA bleeding, pain, and QoL scores were analyzed at the Sutter Institute for Medical Research, Sacramento, CA, using IBM SPSS 21.0
Results
Data for 39 patients were available for analysis. One patient did not complete the MMU. Mean age (years) of participants at the time of PEA was 45.32 ± 4.23 and the current mean age of the participants was 63.73 ± 7.22. The mean follow-up time since ablation was 15.68 ± 5.11 years (Table 1).
There was a reduction in bleeding in 90% of patients after PEA. There was a statistically significant difference (z = 4.38; p = 0.000) in the percent of patients whose bleeding decreased after ablation (90%), compared with patients who had no change in bleeding (10%). No patients reported increased bleeding after ablation (Table 2).
PEA, partial endometrial ablation.
There was a decrease in pain in 45.5% of participants after PEA and no change in pain in 54.5%. No patient reported increase in pain after the procedure (Table 3).
NSAIDS, nonsteroidal anti-inflammatory drugs.
QoL improved by a statistically significant 6.79 ± 1.44 points (Table 4). Overall patient satisfaction was 97%. One patient was dissatisfied and 1 patient was partially satisfied.
t37 = 9.63; p = 0.00.
PEA, partial endometrial ablation; QoL, quality of life; SD, standard deviation.
Nine percent of patients required repeat PEA of the opposite intrauterine wall 4–6 years following the original PEA. All repeat PEA patients went through menopause successfully without additional surgery. Eight percent of patients required hysterectomy for persistent or recurrent AUB.
Of 6 patients with history of tubal ligation at the time of PEA, no increase in pain was observed post-PEA in the follow-up time frame.
Discussion
Total resectoscopic and nonresectoscopic or GEAs are minimally invasive surgical procedures developed as alternatives to hysterectomy for treating intractable heavy menstrual bleeding. The goal of a total or GEA is to destroy the endometrium entirely. This destruction exposes intrauterine myometrium. At the end of the procedure, after the distention fluid and instruments are removed, these myometrial walls collapse and are in juxtaposition. Post-ablation/resection myometrial inflammation and necrosis can potentially result in intrauterine scarring and contracture. This intrauterine scaring has been documented by multiple researchers following both resectoscopic and nonresectoscopic ablations.1–3
The therapeutic goal of PEA is hypo- or eumenorrhea, not amenorrhea, and avoidance of intrauterine adhesions. 4 Although GEA manufactures often define success with post-ablation amenorrhea rates, most women prefer not to have amenorrhea. Niles surveyed 400 women with AUB and found that 80% defined a “successful outcome” as hypo or eumenorrhea, not amenorrhea. 7
The current authors realize that a long-term retrospective study with a 10–20-year follow-up can be problematic and that it might be difficult for patients to recall their pain and QoL accurately several years in the past, which was a weakness of this study. In addition, there was a low response rate. Despite these weaknesses, this study is of value because it demonstrated that long-term improvement in bleeding and QoL was clinically meaningful, suggesting that PEA should be viewed as a viable option for patients with intractable heavy menstrual bleeding.
This data confirmed the shorter-term outcomes found in the original article on PEA. 4 In the current study, 2 cases of endometrial cancer occurred 6–16 years after PEA. These 2 patients did not meet the inclusion criteria and are not presented in the data set. Both presented with postmenopausal bleeding and were readily diagnosed with an in-office endometrial biopsy. Definitive surgery found early stage endometrial carcinoma with no intrauterine scarring.
Longinotti et al. 8 performed a large study encompassing 3,681 patients followed over 8 years. This study evaluated the indications for hysterectomy in post GEA patients for both resectoscopic and non-resectoscopic ablations. The main indication for hysterectomies were bleeding (51.6%), pain (22%), and bleeding with pain (20.3%). Therefore, a component of pain was a major indication for hysterectomy in 42.3% of that patient set. No patients following PEA required a hysterectomy for the indication of increasing pain.
Further explanation of the current study's low hysterectomy rate was that none were performed because of the inability to make an accurate diagnosis when postablation patients returned with AUB, pain, or a suspicious imaging study. Repeat PEA of the opposite wall for recurrent bleeding was successful and all of these patients went through menopause and avoided hysterectomy.
In the current study, QoL scores were improved significantly. This was reflected in a patient satisfaction of >95%.
Litta et al. recently published an article on partial endometrial resection. 9 The researchers followed 73 patients for 5 years. The success rate was 87%, and no painful obstructive problems occurred. At 5 years, all patients consented to a diagnostic hysteroscopy. The intrauterine cavity was noted to be open and the tubal ostia were visualized in every patient. The researchers concluded that partial endometrial resection can be used to treat menorrhagia successfully without causing intrauterine scarring. 9 This avoids long-term complications including delay in the diagnosis of endometrial cancer.1–3
Conclusions
PEA is a minimally invasive surgical procedure that can be used successfully to treat intractable HMB and is not associated with the long-term complications reported after GEA. Previous studies both in the United States 4 and abroad 9 have demonstrated that scaring/contracture does not occur after PEA. Consequently, this ablation/resection modification avoids painful obstructed bleeding problems and allows for accurate future endometrial evaluation. Potential delay in the diagnosis of endometrial cancer is likely avoided. PEA has the potential of becoming a technique which can be used successfully to treat HMB without causing the long-term complications now recognized following total/global endometrial ablations, although long-term studies will be required to confirm that PEAs or resections achieve these goals.
It should be noted that contraception after any ablation should be emphasized. Post GEA pregnancy complications include ectopic pregnancy (generally cervical or cornual) as well as placental implantation abnormalities.10,11 No pregnancies were observed following PEA, but patients must similarly be counseled on the importance of contraception following partial ablation.
Footnotes
Acknowledgments
The authors would like to thank Carol Parise, PhD, Bobbie Benabides, BA, and Debbie Jacobs, RN, at the Sutter Institute for Medical Research, for their invaluable assistance.
This research was funded by a grant (947110-1107545) from the Sutter Institute for Medical Research.
Author Disclosure Statement
Drs. Vance and Arthur McCausland are consultants to Omnitech Systems Inc. in Valparaiso, IN. Dr. Solon Barbis reports no conflict of interest. Dr. Vance McCausland, Dr. Arthur McCausland, and Dr. Solon Barbis report grants from the Sutter Institute for Medical Research while this study was being conducted.
