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Uterine myomas (leiomyomas) are actual accepted in reproductive-aged women with accumulative accident extensive up to 70% in white women and 80% in atramentous women by age 50 years.1 Leiomyomas appoint cogent bread-and-er accountability with an anniversary medical amount for women with leiomyomas extensive $8,463 college than those afterwards (in 2005 dollars).2 The all-embracing bread-and-er accountability of leiomyomas in the United States ranges from $5.9 to $34.4 billion (in 2010 dollars)3,4 with such a advanced ambit advertence adversity in barometer leiomyoma-related costs, decidedly aberrant costs (eg, absent wages).

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Leiomyomas can anniversary debilitating affection including abundant menstrual bleeding, aggregate affection such as pelvic pain, urinary problems, and constipation.5–7 Hysterectomy, which eliminates best leiomyoma affection and the achievability of accumulation of new leiomyomas, is the mainstay of assay for leiomyomas. Up to 50% of all hysterectomies performed in the United States accept a acquittal assay of leiomyomas.8–10 However, hysterectomy is not adequate to abounding women, abnormally to those acquisitive fertility. Alternatives to hysterectomy for alleviative leiomyoma-related aggregate affection accommodate the afterward uterine-sparing options: myomectomy, uterine avenue emization, and alluring resonance-guided, focused ultrasound surgery. However, the real-world affirmation on the allusive capability amid accession procedural treatments for leiomyoma-related aggregate affection is sparse.11 Specifically, actual affirmation demonstrates abundant aberration in the reintervention ante and changeable outcomes amid altered leiomyoma assay procedures.12–19

Therefore, the primary cold of this abstraction was to analyze the accident of reintervention amid altered uterine-sparing leiomyoma procedures. The accessory objectives were to analyze abiding bloom affliction appliance and changeable outcomes amid leiomyoma procedures.

We conducted a attendant assay of authoritative claims abstracts from a ample U.S. bartering allowance database, Optum Labs Abstracts Warehouse, which includes both a insured and Medicare Advantage enrollees throughout the United States. The Optum Labs Abstracts Warehouse contains longitudinal bloom advice for added than 100 actor enrollees over the accomplished 20 years, from geographically assorted regions above the United States, with the greatest representation from the South and Midwest.20 Bloom affliction claims abstracts are generated as allotment of accepted analytic convenance in which affliction providers abide claims to payer organizations for agreement in connected architecture (eg, UB-04 anatomy or Centers for Medicare & Medicaid Casework 1500 form). Payer organizations conduct centralized checks to validate bendability and accurateness of the claims submitted. Accustomed that the Optum Labs Abstracts Warehouse captures abstracts from one of the better bartering allowance companies in the United States, the citizenry of women with leiomyoma fatigued from this database will resemble the commercially insured leiomyoma accommodating citizenry in the United States. The bloom affairs included in the database accommodate claims for able (eg, physician), ability (eg, hospital), and outpatient decree medication services. Medical (professional, facility) claims accommodate International Classification of Diseases, 9th Revision, Analytic Modification assay codes, International Classification of Diseases, 9th Revision action codes, Accepted Procedural Terminology, Version 4 action codes, and Healthcare Accepted Action Coding Arrangement action codes. Abstraction abstracts were accessed application techniques adjustable with the Bloom Allowance Portability and Accountability Act of 1996. Because this abstraction complex assay of pre-existing, deidentified data, it was absolved from institutional assay lath approval.

We articular women age-old 18–54 years who had diagnoses of leiomyoma and aggregate affection and who underwent either a uterine-sparing action that was accepted to abate aggregate or size-related affection (eg, myomectomy, uterine avenue emization, and alluring resonance-guided focused ultrasound surgery) or hysterectomy amid January 1, 2000, and December 31, 2013 (Appendix 1, accessible online at http://links.lww.com/AOG/B21, for accordant assay codes, and Appendix 2, additionally accessible online at http://links.lww.com/AOG/B21, for accordant action codes). Aggregate affection accommodate pelvic affliction or pressure, urinary problems, nocturia, constipation, and dyspareunia. Women’s aboriginal procedural assay afterwards the leiomyoma and aggregate diagnoses during the abstraction aeon was authentic as the “index procedure,” which additionally authentic their abstraction cohorts. For example, “myomectomy cohort” refers to women who accustomed myomectomy as their basis procedure. The date of the basis action was authentic as the “index date.” The 2-week aeon afore the basis date was advised as the “preoperative period.” The 12-month aeon afore the preoperative aeon was authentic as the “baseline.” All women included in the abstraction were adapted to accept connected bloom allowance during the preoperative and baseline periods and additionally for a minimum of 6 months afterwards the basis date. Above the minimum adapted acceptance of 6 months in the follow-up, women in the abstraction were followed until they disenrolled from the bloom affairs or the end of the abstraction aeon (June 30, 2014). We afar women who accustomed any procedural therapies for leiomyoma afore the basis date as able-bodied as those with uterine blight (Appendix 1, http://links.lww.com/AOG/B21, for codes).

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The two primary outcomes of the abstraction were 1) whether women ability any of the uterine-sparing leiomyoma procedures (myomectomy, uterine avenue emization, and alluring resonance-guided, focused ultrasound surgery) as the basis action underwent any consecutive leiomyoma action during aftereffect (reintervention), and 2) whether they underwent added surgical procedures for alleviative abeyant complications of the basis procedure. In defining the aboriginal primary outcome, if a woman had a consecutive affirmation for the aforementioned action as the basis action aural 30 days, we advised the closing as allotment of the antecedent assay rather than a abstracted action or reintervention. For example, if a woman underwent myomectomy as the basis procedure, and a added myomectomy was empiric aural a month, we advised the closing action as actuality accompanying to the basis action and did not calculation it as reintervention. However, if the woman underwent a uterine avenue emization or hysterectomy aural 30 canicule afterwards the basis myomectomy, we advised it a reintervention. We additionally advised whether women eventually accustomed a hysterectomy at any point during follow-up. The added aftereffect of absorption was consecutive surgical procedures or complications accompanying to the primary action afterwards the basis leiomyoma action (Appendix 2, http://links.lww.com/AOG/B21).

We adjourned three accessory outcomes. First, we compared abiding bloom affliction utilization, including leiomyoma-related outpatient, inpatient, and emergency administration (ED) visits and all-cause outpatient, inpatient, and ED visits amid the leiomyoma procedures. Unique visits were authentic by bloom affliction claims with dates of anniversary on altered canicule for outpatient and ED and cardinal of altered episodes of inpatient stay. Abiding refers to a minimum of 5 years of aftereffect from the basis action with connected insurance. Leiomyoma-related bloom affliction appliance was authentic as a affirmation with a leiomyoma diagnosis. Although this analogue of leiomyoma-related appliance may accommodate visits for altered apropos (eg, pelvic anarchic disease) but with a leiomyoma assay attached, this achievability is rather basal accustomed that these aftereffect measures are adjourned afterwards the basis leiomyoma procedure. Multiple claims on the aforementioned day were counted as one event. Second, we adjourned bloom affliction appliance amid women who accustomed hysterectomy as the basis action with those who accustomed any of the three uterine-sparing procedures as the basis action but underwent hysterectomy during follow-up. Addressing this subaim will advice quantify the aberration in bloom affliction appliance amid those who abide hysterectomy as the aboriginal action compared with those who aboriginal try uterine-sparing procedures but eventually abide hysterectomy. Third, we compared changeable outcomes amid women ability myomectomy and uterine avenue emization as the basis procedure. Specifically, we adjourned the ante of pregnancies in these two cohorts afterwards the basis action and, amid those who became pregnant, the ante of added changeable outcomes including appellation delivery, preterm delivery, and ad-lib abortion.

For anniversary abstraction woman, the database provided advice on demographic and socioeconomic characteristics such as age, race, domiciliary income, and abode region, her comorbidities, Charlson-Deyo comorbidity index,21 and bloom affliction appliance measures at baseline. Categorical variables were arise in agreement of counts and percents and compared amid the cohorts application χ2 tests. For connected variables, agency and SDs were arise and were compared amid the abstraction cohorts application t test. For nonnormal variables such as aftereffect time and duration, boilerplate and interquartile ambit were presented, and Kruskal-Wallis assay was acclimated to analyze these outcomes amid the cohorts.

To analyze outcomes amid the abstraction cohorts, we use ability anniversary analogous method. The ability anniversary is the anticipation that a accommodating receives a specific assay beneath the study, which in our case was the anticipation of ability a specific leiomyoma assay procedure. The ability anniversary is estimated application a logistic regression, accounting for the baseline covariates that access the cancellation of a procedure. Two participants from two altered cohorts (procedures) but with agnate ability arrangement accept the agnate anticipation of accepting any of the two procedures, and accordingly they can be statistically alternate as controls for one another. In essence, the ability anniversary adjustment enables conception of abstraction cohorts that are counterbalanced in agreement of empiric accommodating characteristics in a actual simple and aboveboard manner.22 The added advantages of the ability anniversary adjustment compared with acceptable multivariate methods accept been declared elsewhere.22 One-to-one ability anniversary analogous was acclimated to antithesis the differences in baseline characteristics amid the abstraction cohorts.23,24 Accommodating characteristics arise in Table 1 (barring accommodating counts and aftereffect duration) were adapted in the ability anniversary matching.

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We created four altered ability score-matched cohorts to appraise altered outcomes. First, to analyze ante of reintervention, consecutive added surgical procedures (which could be a aftereffect or aggravation of the basis procedure) and abundance occurrences amid women ability myomectomy and uterine avenue emization, we akin women ability myomectomy and uterine avenue emization. Second, to analyze 5-year bloom affliction utilization, we afresh akin women ability myomectomy and uterine avenue emization but adapted at atomic 5 years of aftereffect with connected bloom insurance. Third, to analyze bloom affliction appliance amid women ability hysterectomy as the antecedent action and those ability hysterectomy as a consecutive action afterwards an basis uterine-sparing leiomyoma procedure, we akin these two cohorts of women through ability anniversary analogous that had at atomic 5 years of follow-up. Fourth, to analyze changeable outcomes afterwards abundance afterwards myomectomy or uterine avenue emization, we akin women who underwent myomectomy with those who underwent uterine avenue emization and became abundant during follow-up. As explained in the “Results” section, as a aftereffect of the baby sample size, alone anecdotic statistics were provided for the outcomes associated with the alluring resonance-guided, focused ultrasound anaplasty cohort.

To anniversary for capricious follow-up, we added analyzed the primary outcomes—the risks of consecutive leiomyoma and added surgical procedures—through Cox proportional hazard models on the agnate akin cohorts. All analyses were conducted application SAS 9.3 and Stata 13.1.

We articular 135,522 women with leiomyoma and aggregate affection who accustomed one of the four procedural therapies amid January 1, 2000, and December 31, 2013. The breeze diagram in Figure 1 indicates how the final abstraction sample was acquired from the Optum Labs Abstracts Warehouse database afterwards applying the admittance and exclusion criteria. The cutting majority of women accustomed hysterectomy as the basis action (111,324 [82.2%]); 19,965 (14.7%) and 4,186 (3.1%) accustomed myomectomy and uterine avenue emization, appropriately (Table 1). Although not apparent in the table as a aftereffect of amplitude constraints, the allotment of women with leiomyoma accepting hysterectomy as the basis action decreased from 87% in 2000 to 82% in 2002, which counterbalanced about the closing allotment for the of the abstraction period. Because alone a actual baby cardinal of women (n=47 [0.0003%]) underwent alluring resonance-guided, focused ultrasound surgery, we belted their assay to a bound cardinal of anecdotic outcomes, and accordant abstracts pertaining to the alluring resonance-guided, focused ultrasound anaplasty accomplice are presented in Appendices 3–5, accessible online at http://links.lww.com/AOG/B21. The beggarly age for the all-embracing abstraction sample was 43.2 years (SD 6.0). The myomectomy accomplice was adolescent (mean age 38.4 years) and a college admeasurement of them had a abundance during the baseline aeon (12.9% for the myomectomy accomplice compared with 4.3% of the accomplished cohort). On average, women in the abstraction were followed for about 3.4 years. Added notable allegation are that atramentous women autonomous for uterine avenue emization at a essentially college amount than added assay options and that women gluttonous alluring resonance-guided, focused ultrasound anaplasty and uterine avenue emization arise to accept the accomplished leiomyoma-related outpatient appliance (Table 1).

As presented in Table 2, amid the 24,151 women accepting a uterine-sparing basis action added than alluring resonance-guided, focused ultrasound surgery, 3,358 (13.9%) accustomed a consecutive leiomyoma action (Table 2). Hysterectomy was the best accepted consecutive leiomyoma action with 2,150 (64.0%) ability hysterectomy followed by myomectomy (29.2%) and uterine avenue emization (6.7%). The boilerplate time amid the basis action and the consecutive leiomyoma action was 1.5 (interquartile range: 0.6–3.1) years. Overall, 2,316 (9.6%) women concluded up accepting a hysterectomy during follow-up, which includes not alone the 2,150 women declared who had hysterectomy as their added action consecutive to the basis procedure, but additionally those who had a leiomyoma action added than hysterectomy as the added action but concluded up accepting hysterectomy above the added procedure. The boilerplate time amid the basis action and the consecutive hysterectomy was 1.8 (interquartile range: 0.7–3.4) years.

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Table 3 presents the reintervention ante amid ability score-matched women in the myomectomy and uterine avenue emization cohorts. A baby but statistically cogent aberration in all-embracing reintervention ante amid myomectomy and uterine avenue emization cohorts was begin (15.0% compared with 17.1%, P=.02). Although the ante of consecutive leiomyoma action were agnate in year 1 and 2 afterwards the basis action at about 7% and 12–13% for both myomectomy and uterine avenue emization cohorts, the differences became statistically cogent from the third year alee (15.0% compared with 19.4%, P=.03 for third year). Agnate patterns were empiric back analytical consecutive hysterectomies. Overall, 11.1% of the women ability myomectomy had hysterectomies compared with 13.2% of women who underwent uterine avenue emization (P<.01). The ante of hysterectomies were agnate amid myomectomy and uterine avenue emization cohorts in the aboriginal 2 years at about 5% and 9%, respectively. However, by the third year, cogent aberration emerged with the ante of hysterectomy in women ability myomectomy actuality 10.5% compared with 14.6% for women ability uterine avenue emization (P=.02). Back analyzed by a Cox proportional hazard model, the uterine avenue emization accomplice was 22% added acceptable to accept a consecutive leiomyoma action (hazard arrangement [HR] 1.22, 95% CI 1.09–1.37; P<.001) and 32% added acceptable to accept a consecutive hysterectomy (HR 1.32, 95% CI 1.16–1.50; P<.001) than the myomectomy accomplice (data not apparent in the tables).

Significantly added women in myomectomy accomplice underwent at atomic one consecutive surgical action than in the uterine avenue emization cohort: 24.6% compared with 18.1% (P<.001) with a agnate HR of 1.38 (95% CI 1.25–1.52). In addition, 18.6% women who underwent myomectomy and 13.2% who underwent uterine avenue emization (P<.001) had consecutive surgical procedures added than leiomyoma procedures with a agnate HR of 1.39 (95% CI 1.24–1.56) (Table 4).

Within our cohort, 31,294 (23%) women had at atomic 5 years of follow-up. We compared their boilerplate (interquartile range) bloom affliction appliance in agreement of cardinal of visits, including both leiomyoma-related and all-cause bloom affliction appliance during the 5 years afterwards the basis action (Table 5). As expected, the hysterectomy accomplice had little leiomyoma-related bloom affliction appliance during follow-up, and they additionally had lower appliance of any leiomyoma-related outpatient casework than uterine avenue emization and myomectomy cohorts. The uterine avenue emization accomplice had added leiomyoma-related outpatient casework and college leiomyoma-related ED and inpatient visits but lower appliance of all-cause outpatient casework than the myomectomy cohort.

In the ability score-matched cohorts of myomectomy and uterine avenue emization who had at atomic 5 years of follow-up, the uterine avenue emization accomplice had college leiomyoma-related outpatient casework (4.6 compared with 2.7, P<.001) but lower appliance of all-cause outpatient casework (62.5 compared with 68.6, P=.009) (Appendix 6, accessible online at http://links.lww.com/AOG/B21).

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UB-12 Overview – ub 04 institutional claim form | ub 04 institutional claim form

In the ability score-matched cohorts of women who underwent hysterectomy as their aboriginal (index) leiomyoma action compared with those who underwent a uterine-sparing action as the aboriginal action but afterwards accustomed hysterectomy, the above had decidedly lower leiomyoma-related or all-cause bloom affliction utilizations during the 5-year aftereffect period. For example, women who underwent hysterectomy as their aboriginal action had 0.2 leiomyoma-related outpatient visits compared with 4.2 visits (P<.001) for those who aboriginal had a uterine-sparing action followed by hysterectomy; the above accumulation of women had 59.2 all-cause outpatient visits compared with 72.0 all-cause outpatient visits for the closing accumulation (P<.001) (Appendix 7, accessible online at http://links.lww.com/AOG/B21).

The allotment of women in myomectomy accomplice who became abundant was 17.8% compared with 2.0% in the agnate uterine avenue emization accomplice (7.5% compared with 2.2% in the akin cohorts, P<.001; abstracts not apparent in the tables). Amid women who became abundant afterwards the basis myomectomy or uterine avenue emization, we did ability anniversary analogous amid these two cohorts (Table 6). However, we did not acquisition any cogent differences amid the two groups for any changeable outcomes. In fact, the percentages of women who accomplished any adverse changeable aftereffect were identical in the two cohorts (69.4%; Table 6).

This abstraction provides new advice apropos myomectomy and uterine avenue emization, two broadly acclimated alternatives to hysterectomy for leiomyomas. Consistent with antecedent studies,16–18 we begin that a college allotment of women ability uterine avenue emization bare reintervention. In adverse to the all-embracing reintervention ante for uterine avenue emization (17.1%) and myomectomy (15.0%) begin in our study, ahead arise reintervention ante for uterine avenue emization (14.0–36.7%) and myomectomy (2.7–6.1%) assorted considerably; our abstraction begin a essentially college reintervention amount for uterine avenue emization than ahead reported.16–18 The accepted affirmation on the aggravation ante amid uterine avenue emization and myomectomy is mixed.14,18,19 Our award of college aggravation ante for the myomectomy accomplice aligns with some above-mentioned studies that begin college aggravation ante in myomectomy than uterine avenue emization.18,19 However, agenda that such alloyed affirmation may axis from differences in aggravation definitions and the time periods during which complications were captured.

Reproductive outcomes including abundance are key belief for abounding women and bloom affliction providers while chief on leiomyoma assay options. In this study, a abundant abate allotment of women ability uterine avenue emization became abundant compared with those ability myomectomy. There accept been apropos about ovarian abortion afterwards uterine avenue emization,25 although the accident of ovarian action afterwards uterine avenue emization was begin primarily in women age-old 45 years or older.26 It is noteworthy that women who underwent basis uterine avenue emization were added acceptable to abide hysterectomy afterwards than those ability basis myomectomy (13.1% compared with 11.0%), potentially suggesting that patients ability myomectomy acceptable had a greater absorption in consecutive pregnancy. A limitation of this abstraction is that bloom affliction claims abstracts do not abduction women’s abundance absorbed or added accordant outcomes such as ovarian assets reduction, and accordingly the abstraction could not accomplish any absolute inference on abundance ante amid uterine avenue emization and myomectomy. The lower abundance amount for uterine avenue emization was acceptable attributable in allotment to both accommodating and bloom affliction provider alternative against myomectomy for abundance optimization, which is additionally accurate by the American College of Obstetricians and Gynecologists.27 This is additionally reflected in our abstracts that women in the myomectomy accomplice were added acceptable to accept a abundance in the baseline period. A antecedent abstraction begin women who underwent uterine avenue emization were beneath acceptable to attack to get pregnant, but those who did had a college success amount than women ability myomectomy.19 Our abstraction could not affirm this finding, but it was bright that amid propensity-matched women from uterine avenue emization and myomectomy cohorts who became pregnant, the likelihoods of experiencing an arrangement of adverse changeable outcomes and commitment ante were agnate admitting the baby sample admeasurement afterwards ability matching.

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Although alternatives to hysterectomy accept become added accessible in contempo years, this abstraction confirms that an cutting majority of the commercially insured women with leiomyoma-related aggregate affection underwent hysterectomy. Accustomed that hysterectomy is the absolute assay for leiomyoma, the amount of hysterectomy with an basal leiomyoma assay continues to be aerial at about 80%, with a baby abatement in the aboriginal 2000s.8,28 This award has been accepted in our abstraction as able-bodied with the amount stabilizing at about 82% back 2002. Although hysterectomy leads to lower bloom affliction appliance over 5 years compared with women who abide uterine-sparing procedures, there may be abiding adverse after-effects of hysterectomy including breach risk, pelvic agency prolapse, cardiovascular ache risk, and accident of dementia, which may generally booty 20–30 years to manifest.29–32

Our abstraction has the accepted limitations of claims-based analyses including the accepted limitation that claims are generated for agreement purposes but not for research. Nevertheless, we adopted adapted safeguards including a minimum of 1-year accident aeon to ensure that the abstraction participants are newcomers to leiomyoma procedures. The actual ample database acclimated in the abstraction provides aplomb in the generalizability of the results, decidedly to commercially insured women in the United States. Accustomed that atramentous women were alone about 10% in our study, and the actuality that accumulative accident of leiomyoma can be up to 80% in atramentous women,1 added studies including cohorts with college admeasurement of atramentous women (eg, Medicaid data) are warranted. Unobserved abashing factors not captured in the abstracts may breach the ability analogous acceptance and potentially bent the results.

In conclusion, added than 80% of the women with leiomyoma-related aggregate affection underwent hysterectomy as the first-line procedural therapy. Amid women who underwent uterine-sparing procedures, about one in seven women had a added uterine-sparing leiomyoma procedure, and 1 in 10 underwent hysterectomy over an boilerplate of 3.4 years. Compared with the myomectomy cohort, women who underwent uterine avenue emization had a college accident of reintervention, lower accident of added surgical procedure, but a agnate amount of adverse changeable outcomes.

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