Materials and Methods
Study design
We utilized ACS-NSQIP, which captures >240 patient variables from >460 participating institutions. Outcomes, including VTE, within this database are tracked for 30 days within the postoperative period. The methods of the ACS-NSQIP data collection process were previously described and validated. Data from the ACS-NSQIP database were retrospectively reviewed from 2006 through 2012. Given the nature of the database (national database without patient identifiers) we obtained institutional review board exemption from our institution.
Patients undergoing prolapse and incontinence procedures were selected using Current Procedural Terminology codes for the following procedures in women age >18 years:
Apical repairs
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57280, sacral colpopexy
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57425, laparoscopic sacral colpopexy
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57282, vaginal vault suspension (extraperitoneal)
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57283, vaginal vault suspension (intraperitoneal)
Site-directed repairs
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57250, rectocele repair
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57240, anterior repair
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57268, enterocele repair (vaginal approach)
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57270, enterocele repair (abdominal approach)
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57284, paravaginal repair
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57265, anterior, posterior, and enterocele repair
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57260, anterior and posterior repair
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57284, paravaginal repair
Vaginal closure procedures
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57120, LeFort colpocleisis
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57110, colpectomy (complete removal of vaginal wall)
Concomitant procedures
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58260, 58262, 58263, 58267, 58270, 58275, 58280, 58285, 58290, 58291, 58292, 58293, 58294; vaginal hysterectomy
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58545, 58546, 58548, 58550, 58552, 58553, 58554, 58570, 58571, 58572, 58573; total laparoscopic hysterectomy
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58150, 58152, 58200, 58210; abdominal hysterectomy
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58541, 58542, 58543, 58544; laparoscopic supracervical hysterectomy
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57267, insertion of vaginal mesh
Incontinence procedures
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57288, sling (fascial or synthetic)
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57288, sling removal or revision
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51845, Burch
We defined 2 cohorts: women with any reconstructive pelvic procedure performed, with other concomitant surgeries allowed such as general, vascular, plastics, and gynecologic surgeries (RPS + other), and women whose only procedure was RPS. The primary procedure is designated in the database by a NSQIP nurse responsible for reviewing the case files. Hysterectomies were considered to be primary gynecologic procedures when they were designated the primary Current Procedural Terminology code. Women with known malignancy at time of surgery were excluded from our analysis.
Demographics, comorbidities, and operative variables were tracked as potential risk factors for VTE. Demographic factors included age, race, and body mass index. Comorbidities including smoking, steroid use, diabetes, dyspnea, hypertension, chronic obstructive pulmonary disease, congestive heart failure, bleeding disorders, previous percutaneous coronary intervention or cardiac surgery, previous stroke or transient ischemic attack, functional status, and American Society of Anesthesiology Physical Status (ASA) classification were also collected. There are 6 ASA classes that categorize patients based on their comorbid conditions ranging from status 1 (normal healthy patient) to status 6 (declared brain-dead patient whose organs are being harvested for donor purposes). Operative characteristics included operative time, length of stay (LOS), need for emergency intervention, and inpatient and outpatient status. Emergent intervention was defined if both the surgeon and anesthesiologist documented that the case was “emergent.”
VTE was defined in the database as identification of a new blood clot via duplex, venogram, or computed tomography (CT) scan within 30 days of surgery. Definition also required treatment with anticoagulation therapy, placement of vena cava filter, or clipping of the vena cava. Specifically, PE is defined as ventilation/perfusion scan (V-Q scan) interpreted as high probability of PE or positive CT spiral examination, transesophageal echocardiogram, pulmonary arteriogram, or CT angiogram. We assumed that surgeons followed the ACOG/ACCP risk classification for VTE in surgical patients prevention strategy guidelines, as information regarding thromboprophylaxis was not recorded in the database. Based on the risk stratification, we also assumed that only a small minority of women would fall into the highest risk stratification, which would require pharmaceutical thromboprophylaxis.
Statistical analysis
Perioperative variables were analyzed using χ 2 tests and Student t tests for categorical and continuous variables. We performed a multiple logistic regression to control for confounding variables.
Results
In all, 20,687 women underwent RPS + other during the study period ( Table 1 ). In all, 69 women were diagnosed with VTE (38 with deep vein thrombosis [DVT], 40 with PE, 9 with both) for an incidence of 0.3%. The women in this cohort did have primary procedures other than the reconstructive pelvic procedures including gynecologic, general, vascular, plastic, and orthopedic surgical procedures. Increasing age ( P = .003), longer LOS ( P < .001), longer operative time ( P < .001), inpatient status ( P < .001), poorer functional status ( P < .001), emergency intervention ( P < .001), and higher ASA classification ( P < .001) were associated with increased risk for VTE ( Table 2 ). On multivariate analysis specific predictors for postoperative VTE included inpatient hospital status (odds ratio [OR], 7.69; P < .001), higher ASA classification (OR, 2.70; P < .001), and emergency intervention (OR, 3.65; P = .008).
Type of surgery | CPT codes | n | % (n = 20,687) |
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Vaginal apical repairs | 57282, 57283 | 2809 | 13.6 |
MIS apical repairs | 57425 | 1150 | 5.3 |
Abdominal apical repair | 57280 | 674 | 3.3 |
Anterior/posterior repairs | 57250, 57240, 57268, 57270, 57284, 57265, 57260, 57284 | 8757 | 42.3 |
Vaginal closure procedure | 57120, 57110 | 316 | 1.5 |
Vaginal mesh procedures | 57267 | 1771 | 8.6 |
Incontinence procedures | 57288, 51845 | 10,907 | 52.7 |
Concomitant hysterectomy | |||
Vaginal | 58260, 58262, 58263, 58267, 58270, 58275, 58280, 58285, 58290, 58291, 58292, 58293, 58294 | 320 | 1.5 |
Abdominal | 58150 58152, 58200, 58210 | 1592 | 7.7 |
Laparoscopic | 58545, 58546, 58548, 58550, 58552, 58553, 58554, 58570, 58571, 58572, 58573 58541, 58542, 58543, 58544 | 663 | 3.2 |
Variable | VTE | No VTE | P value |
---|---|---|---|
Total | 69 | 20,618 | |
Age, y | 62.5 | 57.8 | .003 a |
BMI, kg/m 2 | 30.45 | 29.21 | .133 |
Length of stay, d | 10.23 | 1.85 | < .001 a |
Operative time, min | 219.9 | 111.9 | < .001 a |
Age >50 y | 54 | 14,354 | .119 |
Obesity | 30 | 7730 | .331 |
Caucasian | 56 | 16,984 | .791 |
Inpatient/outpatient | 66 | 11,495 | < .001 a |
Clinical characteristics | |||
Smokers | 4 | 2696 | .074 |
Steroid use | 1 | 336 | 1.000 |
Comorbidities | |||
Diabetes | 9 | 2129 | .459 |
Dyspnea | 10 | 1251 | .003 a |
Hypertension | 35 | 8224 | .066 |
Heart disease | 4 | 648 | .173 |
COPD | 2 | 517 | .692 |
Congestive heart failure | 1 | 18 | .062 |
Bleeding disorders | 2 | 209 | .156 |
Previous PCI or cardiac surgery | 3 | 553 | .439 |
Stroke or TIA | 1 | 560 | 1.000 |
Functional status prior to surgery | 6 | 198 | < .001 a |
Open wound infection | 1 | 108 | .306 |
ASA level 3-5 | 42 | 5190 | < .001 a |
When women in the RPS cohort, ie, those with only a RPS performed, were selected and analyzed, 14 were diagnosed with VTE (10 with PE, 7 with DVT, and 3 with both) among 13,023 women for a rate of 0.1%. Cases complicated by VTE were as follows: 2 abdominal sacrocolpopexies; 1 laparoscopic sacrocolpopexy; 1 paravaginal repair; 2 anterior repairs; 2 posterior repairs; 1 combined anterior and posterior repair; 1 combined anterior, posterior, and enterocele repair; and 4 sling procedures. Increasing age ( P = .01), longer LOS ( P < .001), longer operative time ( P < .001), inpatient status ( P < .001), and higher ASA classification ( P = .029) were associated with increased risk for VTE ( Table 3 ). However, on multivariate analysis the only specific predictor for postoperative VTE was LOS (OR, 1.02; P = .037).
Variable | VTE | No VTE | P value |
---|---|---|---|
Total | 14 | 13,009 | |
Age, y | 68.07 | 58.9 | .01 a |
BMI, kg/m 2 | 27.53 | 29.32 | .312 |
Length of stay, d | 6.64 | 3.22 | < .001 a |
Operative time, min | 141 | 77.84 | < .001 a |
Age >50 y | 13 | 94.98 | .094 |
Obesity | 2 | 4971 | .050 a |
Caucasian | 12 | 10,757 | .765 |
Inpatient | 12 | 5429 | < .001 a |
Clinical characteristics | |||
Smokers | 1 | 1616 | .466 |
Steroid use | 0 | 209 | .797 |
Comorbidities | |||
Diabetes | 2 | 1396 | .453 |
Dyspnea | 0 | 817 | .404 |
Hypertension | 5 | 5439 | .431 |
Heart disease | 1 | 454 | .392 |
COPD | 1 | 353 | .320 |
Congestive heart failure | 0 | 6 | .994 |
Bleeding disorders | 0 | 105 | .893 |
Previous PCI or cardiac surgery | 1 | 390 | .382 |
Stroke or TIA | 0 | 395 | .650 |
Functional status prior to surgery | 0 | 95 | .930 |
Open wound infection | 0 | 48 | .950 |
ASA level 3-5 | 7 | 3218 | .029 a |