Abstract
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 was 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, 4th edition codes. Individual patients were followed 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 colporrhapy, 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 < 0.01).
CONCLUSION
Ten years after surgery for POP, the reoperation rate was significantly reduced when a concomitant apical suspension procedure was performed.
INTRODUCTION
The prevalence of pelvic organ prolapse (POP) approaches 40% and will continue to rise 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 due to increasing awareness of mesh related complications as well as the FDA 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 impact 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, 9, 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 data set 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, comprised of national de-identified administrative and claims data on a random 5% sample of the United States Medicare population, were obtained from the Centers for Medicare and Medicaid Services (CMS). 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 ICD-9-CM and CPT-4 codes, were included in the study (Appendix 1). 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 into whether or not a concomitant apical suspension procedure was performed. Apical suspension procedures included both vaginal and abdominal colpopexy (vault suspension), enterocele repair, and concomitant hysterectomy.
Appendix 1.
International Classification of Diseases-9-Clinical Modification and Current Procedural Terminology, 4th Edition Procedure Codes Used to Identify Patients Treated for Vaginal Prolapse
| ICD-9-CM Codes | CPT Codes | |
|---|---|---|
| Nonsurgical | 57160 Insertion pessary | |
| 57150 Irrigation after pessary | ||
| 57415 Removal impacted pessary | ||
| A4561/A462 outpatient pessary | ||
| Colpocleisis | 70.8 Le Fort | 57120 Le Fort |
| Anterior repair | 70.51 Repair cystocele | 57240 Anterior colporrhaphy |
| 70.54 Repair cystocele with graft or prosthesis | 57289 Pereyra | |
| 618.00 Unspecified prolapse of vaginal walls | 57284 Paravaginal defect repair (abdominal) | |
| 618.01 Cystocele, midline | ||
| 618.02 Cystocele, lateral | ||
| 618.02 Urethrocele | ||
| 57285 Paravaginal defect repair (vaginal) | ||
| 57423 Paravaginal defect repair (laparoscopic) | ||
| Anterior + posterior repair | 70.50 Repair cystocele and rectocele | 57260 Combined anteroposterior colporrhaphy |
| 70.53 Repair of cystocele and rectocele with graft or prosthesis | ||
| Anterior + posterior + apical repair | 57265 Combined anteroposterior colporrhaphy with enterocele repair | |
| Posterior repair | 70.52 Repair of rectocele | 45560 Repair of rectocele |
| 70.55 Repair of rectocele with graft or prosthesis | 56810 Perineoplasty, non-obstetric | |
| 618.04 Rectocele | 57250 Posterior colporrhaphy with/without perineorrhaphy | |
| 618.05 Perineocele | ||
| 618.09 Other prolapse of vaginal walls without mention of uterine prolapse | ||
| Apical repair | 70.92 Repair of vaginal enterocele | 57268 Repair of enterocele (vaginal) |
| 70.93 Repair of vaginal enterocele with graft of prosthesis | 57270 Repair of enterocele (abdominal) | |
| 57280 Colpopexy (abdominal) | ||
| 70.77 Vaginal suspension and fixation | 57282 Colpopexy (vaginal; extra-peritoneal) | |
| 70.78 Vaginal suspension and fixation with graft or prosthesis | 57283 Colpopexy (vaginal; intra-peritoneal) | |
| 57425 Colpopexy (laparoscopic) | ||
| 69.22 Uterine suspension | 58400 Uterine suspension | |
| 58410 Uterine suspension with presacral sympathectomy | ||
| 683.1 Laparoscopic supracervical hysterectomy | 58150 Total abdominal hysterectomy (TAH) | |
| 68.39 Other unspecified subtotal abdominal hysterectomy | 58152 TAH with colpo-urethrocystopexy | |
| 58180 Supracervical abdominal hysterectomy | ||
| 58541/58570 Lap hys (<250 g) | ||
| 58543/58571 Lap hys (>250 g) | ||
| 68.3 Subtotal hysterectomy | 58260 Vaginal hysterectomy (<250 g) | |
| 68.5 Vaginal hysterectomy for prolapse | 58267 Vag hys with colpo-urethrocystopexy | |
| 68.51 Lap vag hys | 58270 Vag hys with repair of enterocele | |
| 68.59 Other unspecified vag hys | 58280 Vag hys and partial vaginectomy with repair of enterocele | |
| 618.1 Uterine prolapse without mention of vaginal wall prolapse | ||
| 618.2 Uterovaginal prolapse, incomplete | 58290 Vag hys (>250 g) | |
| 618.3 Uterovaginal prolapse, complete | ||
| 618.4 Uterovaginal prolapse, unspecified | ||
| 618.5 Prolapse of vaginal vault after hysterectomy | 58292 Vag hys (>250 g) with removal tube +/− ovary and repair of enterocele | |
| 618.6 Vaginal enterocele, congenital or acquired | 58293 Vag hys (>250 g) with colpo-urethrocystopexy | |
| 618.7 Old laceration of muscles of pelvic floor | 58294 Vag hys (>250 g) with repair of enterocele | |
| 618.81 Incompetence or weakening of pubocervical tissue | ||
| 618.82 Incompetence or weakening of rectovaginal tissue | ||
| 618.83 Pelvic muscle wasting | ||
| 618.84 Cervical stump prolapse | ||
| 618.89 Other specified genital prolapse | ||
| 618.9 Unspecified genital prolapse |
ICD-9-CM, International Classification of Diseases, 9th revision, Clinical Modification; CPT, current procedural terminology.
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 next 10 years (through the end of 2009). Diagnosis codes alone cannot reliably identify recurrent prolapse as 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 study’s primary outcome. We also included insertion of a pessary as evidence of a symptomatic prolapse recurrence. Cumulative recurrence rates over the 10 years of follow-up were reported. Fisher’s exact test was used to detect statistically significant differences between patients receiving different types of surgical procedures.
RESULTS
In 1999, 21,245 women within the 5% national random sample were diagnosed with pelvic organ prolapse (POP). Of these, 3,244 (15.3%) had surgery for POP: anterior colporrhaphy, posterior colporrhaphy, repair of enterocele, colpopexy, uterine suspension, colpocleisis, and/or hysterectomy. Patient demographics are summarized in Table 1. Mean age was 72.2 (range: 65–96). The most common race was Caucasian (91.9%) followed by Black (3.5%) and Hispanic (1.8%). The surgical procedures were performed transvaginally in 2,756 (84.9%) of cases. We categorized all isolated anterior colporrhaphy and posterior colporrhaphy procedures as a vaginal case 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 the entire cohort. The mean duration of follow-up was 9.0 years (range 8.9 to 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.
Table 1.
Patient Demographics
| Prolapse Patients With Any Surgery (n=3244) | ||
|---|---|---|
| Age, mean, SD | 72.2 | (5.9) |
| Age, n (%) | ||
| 65–69 | 1178 | (36.3) |
| 70–74 | 887 | (27.3) |
| 75–79 | 710 | (21.9) |
| 80–84 | 352 | (10.9) |
| 85+ | 117 | (3.6) |
| Race, n (%) | ||
| White | 2981 | (91.9) |
| Black | 114 | (3.5) |
| Other | 56 | (1.7) |
| Asian | 9 | (0.3) |
| Hispanic | 58 | (1.8) |
| North American Native | 3 | (0.1) |
| Unknown | 23 | (0.7) |
| Charlson Comorbidity | ||
| Index, n (%) | ||
| 0 | 1477 | (45.5) |
| 1 | 533 | (16.4) |
| 2 | 577 | (17.8) |
| 3 | 283 | (8.7) |
| 4 | 374 | (11.5) |
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 women whose index surgery was an anterior colporrhaphy combined with a procedure for apical support (20.2% vs. 11.6%, respectively, p < 0.01). 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 versus 10.2% if an apical suspension was initially performed (p = 0.01). The overall reoperation rate for recurrent prolapse between women who initially underwent posterior colporrhaphy alone (14.6%) versus posterior colporrhaphy combined with an apical suspension (12.9%) was not statistically significant (p = 0.60). However, the rate of repeat posterior colporrhaphy was significantly higher in the subgroup that underwent an isolated posterior repair than in the group whose index posterior colporrhaphy was performed with an apical suspension procedure (4.5% vs. 0.4%, respectively, p < 0.01). Conversely, there was a higher rate of reoperation (anterior + apical procedure) for the group whose index prolapse surgery was posterior colporrhaphy combined with an apical support procedure versus the group whose initial surgery was posterior colporrhaphy alone (2.1% vs. 0.0%, respectively, p = .029). We did not observe any significant difference in rate of pessary placement between groups.
Table 2.
Cumulative Reoperation Rates After Index Prolapse Surgery
| Anterior | Anterior + Apical | P Value: Anterior vs. Apical | Posterior | Posterior + Apical | P Value: Posterior vs. Posterior + Apical | Anterior–Posterior | Anterior–Posterior + Apical | P Value Anterior–Posterior vs. Anterior–Posterior + Apical | |
|---|---|---|---|---|---|---|---|---|---|
| Number of procedures for recurrence | 382 | 258 | 246 | 241 | 469 | 1160 | |||
| Cumulative reoperation rate all procedures | 20.2% | 11.6% | 0.005 | 14.6% | 12.9% | 0.600 | 14.7% | 10.2% | 0.013 |
| Cumulative reoperation rate per procedure | |||||||||
| Pessary insertion | 6.0% | 5.0% | 0.727 | 6.1% | 5.0% | 0.693 | 4.3% | 5.0% | 0.609 |
| Colpocleisis | 1.3% | 0.8% | 0.707 | 0.0% | 1.2% | 0.120 | 0.9% | 0.5% | 0.486 |
| Anterior | 4.2% | 1.9% | 0.173 | 3.3% | 2.5% | 0.788 | 2.3% | 1.8% | 0.554 |
| Anterior + apical | 1.0% | 0.0% | 0.152 | 0.0% | 2.1% | 0.029 | 0.6% | 1.3% | 0.307 |
| Posterior | 4.7% | 3.1% | 0.415 | 4.5% | 0.4% | 0.006 | 1.7% | 1.4% | 0.651 |
| Posterior + apical | 4.7% | 2.3% | 0.140 | 1.6% | 1.2% | 1.000 | 1.5% | 1.4% | 0.820 |
| Anterior–posterior | 2.9% | 1.6% | 0.425 | 1.6% | 3.7% | 0.170 | 1.9% | 1.0% | 0.153 |
| Anterior–posterior + apical | 4.2% | 1.6% | 0.066 | 2.0% | 1.7% | 1.000 | 3.2% | 2.1% | 0.209 |
| Apical | 4.7% | 3.1% | 0.415 | 2.4% | 3.7% | 0.443 | 3.4% | 2.9% | 0.635 |
DISCUSSION
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 that provides novel, population-based information regarding the association of vaginal apical support with long-term prolapse recurrence.
Our results on 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 had 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 after an isolated posterior colporrhaphy (0.4% vs 4.5%, p<0.01). 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 impact 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 as 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 groups that did and did not have an apical suspension procedure at the time of initial surgery may have been due to a pessary placed for incontinence and not prolapse, or a pessary may have been inserted for more severe symptoms prior to surgery. Hence, the data we report on reoperation may represent a more accurate reflection of POP recurrence than pessary data.
The strength of our study lies in the fact that the CMS Public Use File data enables 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 which 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, in order 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 supports the apex but is 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) and therefore we were unable to identify if any of the cases utilized 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 indeed 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. 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.
Acknowledgments
Funded by the NIDDK (1 K23 DK080227-05, JTA) and an American Recovery and Reinvestment Act (ARRA) Supplement.
Footnotes
Disclosure of Potential Conflicts of Interest
Karyn S. Eilber is a speaker for Astellas, an investigator and consultant for American Medical Systems, and an investigator for Boston Scientific.
J. Quentin Clemens is a consultant for Medtronic, Afferent Pharmaceuticals, and Amphora Medical.
All other authors have no potential conflicts of interest to report.
References
- 1.Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women’s Health Initiative: gravity and gravidity. Am J Obstet Gynecol. 2002;186(6):1160–6. doi: 10.1067/mob.2002.123819. [DOI] [PubMed] [Google Scholar]
- 2.Luber KM, Boero S, Choe JY. The demographics of pelvic floor disorders: current observations and future projections. Am J Obstet Gynecol. 2001;186:1496–1501. doi: 10.1067/mob.2001.114868. [DOI] [PubMed] [Google Scholar]
- 3.Olsen AL, Smith VJ, Bergstrom JO, et al. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501–6. doi: 10.1016/S0029-7844(97)00058-6. [DOI] [PubMed] [Google Scholar]
- 4.Handel LN, Frenkl TL, Kim YH. Results of cystocele repair: a comparison of traditional anterior colporrhaphy, polypropylene mesh, and porcine dermis. J Urol. 2007 Jul;1781(1):153–6. doi: 10.1016/j.juro.2007.03.041. [DOI] [PubMed] [Google Scholar]
- 5.FDA. Public Health Notification: Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. 2011 Jul 13; doi: 10.1016/j.eururo.2009.01.055. [DOI] [PubMed] [Google Scholar]
- 6.DeLancey JOL. Anatomic aspects of vaginal eversion after hysterectomy. Am J Obstet Gynecol. 1992;166:1717–28. doi: 10.1016/0002-9378(92)91562-o. [DOI] [PubMed] [Google Scholar]
- 7.Summers A, Winkel LA, Kussain H, DeLancey JOL. The relationship between anterior and apical compartment support. Am J Obstet Gynecol. 2006;194:1438–43. doi: 10.1016/j.ajog.2006.01.057. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8.Lowder JL, Park AJ, Ellison E, Ghetti C, Moalli P, Zyczynski H, Weber AM. The role of apical vaginal support in the appearance of anterior and posterior vaginal prolapse. Obstet Gynecol. 2008;111:152–57. doi: 10.1097/01.AOG.0000297309.25091.a0. [DOI] [PubMed] [Google Scholar]
- 9.Rooney K, Kenton K, Mueller ER, et al. Advanced anterior vaginal wall prolapse is highly correlated with apical prolapse. Am J Obstet Gynecol. 2006 Dec;195(6):1837–40. doi: 10.1016/j.ajog.2006.06.065. [DOI] [PubMed] [Google Scholar]
- 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 Jan;189(1):200–203. doi: 10.1016/j.juro.2012.08.177. [DOI] [PubMed] [Google Scholar]
- 11.Kenton K, Sadowski D, Shott S, Brubaker L. A comparison of women with primary and recurrent pelvic organ prolapse. Am J Obstet Gynecol. 1999;180:1415–8. doi: 10.1016/s0002-9378(99)70027-x. [DOI] [PubMed] [Google Scholar]
- 12.Alperin M, Khan A, Dubina E, Tarnay C, Wu N, Pashos CL, Anger JT. Patterns of pessary care and outcomes for Medicare beneficiaries with pelvic organ prolapse. Female Pelvic Med Reconstr Surg. 2013;19(3):142–7. doi: 10.1097/SPV.0b013e31827e857c. [DOI] [PMC free article] [PubMed] [Google Scholar]