Obstetrics & Gynecology:
Pelvic Floor Disorders Research: Original Research
Outcomes of Vaginal Prolapse Surgery Among Female Medicare Beneficiaries: The Role of Apical Support
Eilber, Karyn S. MD; Alperin, Marianna MD; Khan, Aqsa MD; Wu, Ning PhD; Pashos, Chris L. PhD; Clemens, J. Quentin MD, MSCI; Anger, Jennifer T. MD, MPH
Division of Urology, Cedars-Sinai Medical Center Department of Surgery, and the Department of Urology, University of California, Los Angeles, Los Angeles, the Department of Reproductive Medicine, University of California, San Diego School of Medicine, San Diego, and United BioSource Corporation, San Francisco, California; and the Department of Urology, University of Michigan, Ann Arbor, Michigan.
Corresponding author: Jennifer T. Anger, MD, MPH, Associate Director of Urological Research, Cedars-Sinai Medical Center, 99 N. La Cienega Boulevard, #307, Beverly Hills, CA 90211; e-mail: Jennifer.Anger@cshs.org.
Funded by the NIDDK (1 K23 DK080227-05, JTA) and an American Recovery and Reinvestment Act (ARRA) Supplement.
Financial Disclosure Dr. Eilber is a speaker for Astellas, an investigator and consultant for American Medical Systems, and an investigator for Boston Scientific. Dr. Clemens is a consultant for Medtronic, Afferent Pharmaceuticals, and Amphora Medical. The other authors did not report any potential conflicts of interest.
OBJECTIVE: Recurrent pelvic organ prolapse (POP) has been attributed to many factors, one of which is lack of vaginal apical support. To assess the role of vaginal apical support and POP, we analyzed a national dataset to compare long-term reoperation rates after prolapse surgery performed with and without apical support.
METHODS: Public use file data on a 5% random national sample of female Medicare beneficiaries were obtained from the Centers for Medicare and Medicaid Services. Women with POP who underwent surgery during 1999 were identified by relevant International Classification of Diseases, 9th Revision, Clinical Modification, and Current Procedural Terminology, Fourth Edition codes. Individual patients were followed-up through 2009. Prolapse repair was categorized as anterior, posterior, or anterior–posterior with or without a concomitant apical suspension procedure. The primary outcome was the rate of retreatment for POP.
RESULTS: In 1999, 21,245 women had a diagnosis of POP. Of these, 3,244 (15.3%) underwent prolapse surgery that year. There were 2,756 women who underwent an anterior colporrhaphy, posterior colporrhaphy, or both with or without apical suspension. After 10 years, cumulative reoperation rates were highest among women who had an isolated anterior repair (20.2%) and significantly exceeded reoperation rates among women who had a concomitant apical support procedure (11.6%; P<.01).
CONCLUSION: Ten years after surgery for POP, the reoperation rate was significantly reduced when a concomitant apical suspension procedure was performed. This analysis of a national cohort suggests that the appropriate use of a vaginal apical support procedure at the time of surgical treatment of POP might reduce the long-term risk of prolapse recurrence.
LEVEL OF EVIDENCE: II
The prevalence of pelvic organ prolapse (POP) approaches 40% and will continue to increase as the population ages.1,2 Unfortunately, recurrence rates after prolapse surgery have been reported as high as 29%.3 The significant failure rate of POP surgery led surgeons to augment native tissue repairs with biologic grafts or synthetic mesh; however, use of biologic grafts has not been definitively shown to improve outcomes, and the use of synthetic mesh has been reduced because of increasing awareness of mesh-related complications as well as the U.S. Food and Drug Administration Public Health Notification regarding use of synthetic mesh for transvaginal repair of POP.4,5 Thus, it is crucial to identify surgical variables that may have an effect on outcomes of POP repair.
A pivotal role of level I (apical) vaginal support has been demonstrated,6 and loss is a major factor in the development of symptomatic apical and anterior wall prolapse.7 Simulated restoration of apical support has been shown to correct both anterior and posterior vaginal prolapse, and the invariable relationship between high-stage anterior wall prolapse and loss of apical support has also been demonstrated.8–10 Traditionally, the most frequently performed procedures for POP have been anterior or posterior colporrhaphy, with fewer patients undergoing vaginal apical suspension.11
To investigate the role of vaginal apical suspension in long-term outcomes of prolapse repair, we used a national dataset to compare reoperation rates after prolapse surgery performed with and without an apical support procedure.
MATERIALS AND METHODS
The Institutional Review Board of University of California, Los Angeles, determined this study to be exempt. Medicare public use file data comprising national deidentified administrative and claims data of a random 5% sample of the United States Medicare population were obtained from the Centers for Medicare and Medicaid Services. An analytical cohort was identified using the public use file data that included a 5% random national sample of female Medicare beneficiaries aged 65 years and older. Within this sample, only women who underwent prolapse surgery during the year 1999, as identified by relevant International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) and Current Procedural Terminology, Fourth Edition (CPT-4) codes, were included in the study (Appendix). Prolapse repair was categorized into anterior colporrhaphy alone, posterior colporrhaphy alone, combined anterior and posterior colporrhaphy, or colpocleisis. Except for colpocleisis, these were further categorized depending on whether a concomitant apical suspension procedure was performed. Apical suspension procedures included both vaginal and abdominal colpopexy (vault suspension), enterocele repair, and concomitant hysterectomy.
The same set of ICD-9-CM and CPT-4 codes were subsequently used to identify which of these patients had recurrence of prolapse over the subsequent 10 years (through the end of 2009). Diagnosis codes alone cannot reliably identify recurrent prolapse because preoperative diagnoses may remain on a patient's problem list even after surgery; therefore, we exclusively identified recurrent POP by treatment after the index surgery. A reoperation for prolapse served as the primary outcome of the study. We also included insertion of a pessary as evidence of a symptomatic prolapse recurrence. Cumulative recurrence rates over the course of the 10 years of follow-up were reported. Fisher exact test was used to detect statistically significant differences between patients receiving different types of surgical procedures.
In 1999, 21,245 women within the 5% national random sample had POP diagnosed. Of these, 3,244 (15.3%) underwent the following types of surgery for POP: anterior colporrhaphy; posterior colporrhaphy; repair of enterocele; colpopexy; uterine suspension; colpocleisis; or hysterectomy. Patient demographics are summarized in Table 1. Mean age was 72.2 years (range 65–96). The most common race was white (91.9%), followed by black (3.5%) and Hispanic (1.8%). The surgical procedures were performed transvaginally in 2,756 (84.9%) cases. We categorized all isolated anterior colporrhaphy and posterior colporrhaphy procedures as vaginal cases unless there was an associated CPT code for an abdominal procedure. The demographic characteristics of the subgroup who had surgery performed transvaginally were similar to those of the entire cohort. The mean duration of follow-up was 9.0 years (range 8.9–9.2). During the 10-year study period, 26.9% (range 24.5–31.8%) of patients died. These figures were similar across all subcohorts.
Of the 2,756 vaginal cases, 382 (13.9%) patients had anterior colporrhaphy alone, 256 (9.3%) had anterior colporrhaphy with a vaginal apical suspension procedure, 246 (8.9%) had posterior colporrhaphy alone, 241 (8.8%) had posterior colporrhaphy with an apical suspension, 469 (17.0%) patients had combined anterior and posterior colporrhaphy, and the remaining 1,160 (42.1%) patients had combined anterior and posterior colporrhaphy with an apical suspension procedure.
The rates of retreatment for recurrent POP over the 10-year follow-up are summarized in Table 2. The highest cumulative reoperation rate was observed in women who initially underwent an isolated anterior colporrhaphy (20.2%). The reoperation rate after an isolated anterior colporrhaphy was significantly greater than that for women whose index surgery was an anterior colporrhaphy combined with a procedure for apical support (20.2% compared with 11.6%, respectively; P<.01). A similar finding was observed for patients who initially underwent a combined anterior and posterior colporrhaphy with or without a concomitant apical suspension procedure. The reoperation rate was 14.7% if a combined anterior and posterior colporrhaphy was performed without an apical procedure compared with 10.2% if an apical suspension was initially performed (P=.01). The overall reoperation rate for recurrent prolapse between women who initially underwent posterior colporrhaphy alone (14.6%) compared with posterior colporrhaphy combined with an apical suspension (12.9%) was not statistically significant (P=.60). However, the rate of repeat posterior colporrhaphy was significantly higher in the subgroup of patients who underwent an isolated posterior repair than it was in the group whose index posterior colporrhaphy was performed with an apical suspension procedure (4.5% compared with 0.4%, respectively; P<.01). Conversely, there was a higher rate of reoperation (anterior plus apical procedure) for the group whose index prolapse surgery was posterior colporrhaphy combined with an apical support procedure compared with the group whose initial surgery was posterior colporrhaphy alone (2.1% compared with 0.0%, respectively; P=.029). We did not observe any significant difference in rate of pessary placement between groups.
Table 2-a Cumulative...Image Tools
Table 2-b Cumulative...Image Tools
Reoperation for recurrent prolapse is significantly reduced when a concomitant vaginal apical suspension procedure is performed at the time of prolapse surgery. We analyzed a representative cohort of Medicare beneficiaries; this provided novel, population-based information regarding the association of vaginal apical support with long-term prolapse recurrence.
Our results using a large national sample of patients reinforce and strengthen previous single-center findings that apical descent is a significant contributor to prolapse of the anterior compartment, and that correcting apical descent significantly reduces anterior compartment reoperation rates.7–10 The highest cumulative reoperation rate of 20% in our cohort occurred after an isolated anterior colporrhaphy. This rate was decreased by almost half when an apical suspension procedure was performed at the time of index surgery. A number of the subsequent operations after failed anterior colporrhaphy with or without apical suspension occurred in the posterior compartment, which may actually represent prolapse of an initially unreinforced compartment rather than a true recurrence. However, when we examined the group who underwent combined anterior–posterior colporrhaphy with and without apical suspension, a significant reduction in treatment for recurrent prolapse was again noted.
Interestingly, an apical suspension procedure performed at the time of posterior colporrhaphy also markedly reduced the overall rate of reoperation for recurrent rectocele. The reoperation rate after a posterior repair combined with an apical procedure was 10-fold lower than that after an isolated posterior colporrhaphy (0.4% compared with 4.5%; P<.01). However, this did not hold true for all subgroups. Patients whose reoperation was colpocleisis, anterior colporrhaphy with an apical procedure, anterior and posterior colporrhaphy, or an apical procedure alone did not benefit from an apical procedure at the time of posterior colporrhaphy. Although loss of apical support in the pathogenesis of posterior compartment prolapse is less well-established than for the anterior compartment, our finding of an overall decreased reoperation rate when posterior colporrhaphy is combined with an apical procedure suggests a significant effect of apical support on posterior vaginal wall prolapse, as previously observed by Lowder et al.8
Our analysis of patients treated with a pessary was restricted to those who had a CPT code for an initial pessary fitting because there is no specific code for pessary follow-up visits. Our group has previously addressed coding issues related to pessary use in the Medicare population.12 The observation that pessary use was similar between patient groups who did and did not have an apical suspension procedure at the time of initial surgery may have been attributable to a pessary placed for incontinence and not prolapse, or a pessary may have been inserted for more severe symptoms before surgery. Hence, the data we report regarding reoperation may represent a more accurate reflection of POP recurrence than pessary data.
The strength of our study lies in the fact that the Centers for Medicare and Medicaid Services public use file data enable analysis of a large sample of patients within a broad geographic distribution as well as assessment of long-term outcomes. However, there are inherent limitations to a claims-based analysis. Specifically, diagnoses are identified by ICD-9-CM codes that do not provide complete clinical details. As such, it is not possible to assess the degree or severity of prolapse that clearly influences reoperation rates. Furthermore, procedures are identified by ICD-9-CM and CPT-4 codes that may be used in different ways by different clinicians because of coding ambiguities. This is particularly true when multiple codes exist for a given operation or combination of procedures. For example, to capture all apical procedures, we categorized enterocele and hysterectomy as apical procedures. Although these are not apical support procedures per se, many providers perform other procedures, such as uterosacral plication, at the time of vaginal hysterectomy that effectively support the apex but are not necessarily coded as such. In addition, the index year in this study (1999) occurred well before the CPT code for mesh insertion (CPT-4 code 57267) was created (2005); therefore, we were unable to identify whether any of the cases involved mesh. However, we anticipate that mesh use was low overall in 1999. Despite these aforementioned limitations, the findings in our study suggest that the observed, clinically relevant outcomes depend on vaginal apical support. Supporting the vaginal apex at the time of prolapse surgery may fill the void that biologic and synthetic grafts have been unable to fill. Prospective studies are needed to confirm these findings. This analysis of a representative national cohort of Medicare beneficiaries suggests that the appropriate use of a vaginal apical support procedure at the time of surgical treatment of POP might reduce the long-term risk of prolapse recurrence.
International Classification of Diseases-9-Clinical Modification and Current Procedural Terminology, 4th Edition Procedure Codes Used to Identify Patients Treated for Vaginal Prolapse Cited Here...
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9. Rooney K, Kenton K, Mueller ER, FitzGerald MP, Brubaker L. Advanced anterior vaginal wall prolapse is highly correlated with apical prolapse. Am J Obstet Gynecol 2006;195:1837–40.
10. Elliott CS, Yeh J, Comiter CV, Chen B, Sokol ER. The predictive value of a cystocele for concomitant vaginal apical prolapse. J Urol 2013;189:200–3.
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12. Alperin M, Khan A, Dubina E, Tarnay C, Wu N, Pashos CL, et al.. Patterns of pessary care and outcomes for Medicare beneficiaries with pelvic organ prolapse. Female Pelvic Med Reconstr Surg 2013;19:142–7.
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© 2013 by The American College of Obstetricians and Gynecologists.
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