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Background: We previously reported significant associations between genetic variants in insulin receptor substrate 1 (IRS1) and breast cancer risk in women carrying BRCA1 mutations. The objectives of this study were to investigate whether the IRS1 variants modified ovarian cancer risk and were associated with breast cancer risk in a larger cohort of BRCA1 and BRCA2 mutation carriers., Methods: IRS1 rs1801123, rs1330645, and rs1801278 were genotyped in samples from 36 centers in the Consortium of Investigators of Modifiers of BRCA1/2 (CIMBA). Data were analyzed by a retrospective cohort approach modeling the associations with breast and ovarian cancer risks simultaneously. Analyses were stratified by BRCA1 and BRCA2 status and mutation class in BRCA1 carriers., Results: Rs1801278 (Gly972Arg) was associated with ovarian cancer risk for both BRCA1 (HR, 1.43; 95% confidence interval (CI), 1.06-1.92; P = 0.019) and BRCA2 mutation carriers (HR, 2.21; 95% CI, 1.39-3.52, P = 0.0008). For BRCA1 mutation carriers, the breast cancer risk was higher in carriers with class II mutations than class I mutations (class II HR, 1.86; 95% CI, 1.28-2.70; class I HR, 0.86; 95%CI, 0.69-1.09; P(difference), 0.0006). Rs13306465 was associated with ovarian cancer risk in BRCA1 class II mutation carriers (HR, 2.42; P = 0.03)., Conclusion: The IRS1 Gly972Arg single-nucleotide polymorphism, which affects insulin-like growth factor and insulin signaling, modifies ovarian cancer risk in BRCA1 and BRCA2 mutation carriers and breast cancer risk in BRCA1 class II mutation carriers., Impact: These findings may prove useful for risk prediction for breast and ovarian cancers in BRCA1 and BRCA2 mutation carriers., (©2012 AACR.)

Purpose: The primary objective was to establish noninferiority of laparoscopy compared with laparotomy for recurrence after surgical staging of uterine cancer., Patients and Methods: Patients with clinical stages I to IIA disease were randomly allocated (two to one) to laparoscopy (n = 1,696) versus laparotomy (n = 920) for hysterectomy, salpingo-oophorectomy, pelvic cytology, and pelvic and para-aortic lymphadenectomy. The primary study end point was noninferiority of recurrence-free interval defined as no more than a 40% increase in the risk of recurrence with laparoscopy compared with laparotomy., Results: With a median follow-up time of 59 months for 2,181 patients still alive, there were 309 recurrences (210 laparoscopy; 99 laparotomy) and 350 deaths (229 laparoscopy; 121 laparotomy). The estimated hazard ratio for laparoscopy relative to laparotomy was 1.14 (90% lower bound, 0.92; 95% upper bound, 1.46), falling short of the protocol-specified definition of noninferiority. However, the actual recurrence rates were substantially lower than anticipated, resulting in an estimated 3-year recurrence rate of 11.4% with laparoscopy and 10.2% with laparotomy, or a difference of 1.14% (90% lower bound, -1.28; 95% upper bound, 4.0). The estimated 5-year overall survival was almost identical in both arms at 89.8%., Conclusion: This study previously reported that laparoscopic surgical management of uterine cancer is superior for short-term safety and length-of-stay end points. The potential for increased risk of cancer recurrence with laparoscopy versus laparotomy was quantified and found to be small, providing accurate information for decision making for women with uterine cancer.

Purpose: The objective was to compare laparoscopy versus laparotomy for comprehensive surgical staging of uterine cancer., Patients and Methods: Patients with clinical stage I to IIA uterine cancer were randomly assigned to laparoscopy (n = 1,696) or open laparotomy (n = 920), including hysterectomy, salpingo-oophorectomy, pelvic cytology, and pelvic and para-aortic lymphadenectomy. The main study end points were 6-week morbidity and mortality, hospital length of stay, conversion from laparoscopy to laparotomy, recurrence-free survival, site of recurrence, and patient-reported quality-of-life outcomes., Results: Laparoscopy was initiated in 1,682 patients and completed without conversion in 1,248 patients (74.2%). Conversion from laparoscopy to laparotomy was secondary to poor visibility in 246 patients (14.6%), metastatic cancer in 69 patients (4.1%), bleeding in 49 patients (2.9%), and other cause in 70 patients (4.2%). Laparoscopy had fewer moderate to severe postoperative adverse events than laparotomy (14% v 21%, respectively; P < .0001) but similar rates of intraoperative complications, despite having a significantly longer operative time (median, 204 v 130 minutes, respectively; P < .001). Hospitalization of more than 2 days was significantly lower in laparoscopy versus laparotomy patients (52% v 94%, respectively; P < .0001). Pelvic and para-aortic nodes were not removed in 8% of laparoscopy patients and 4% of laparotomy patients (P < .0001). No difference in overall detection of advanced stage (stage IIIA, IIIC, or IVB) was seen (17% of laparoscopy patients v 17% of laparotomy patients; P = .841)., Conclusion: Laparoscopic surgical staging for uterine cancer is feasible and safe in terms of short-term outcomes and results in fewer complications and shorter hospital stay. Follow-up of these patients will determine whether surgical technique impacts pattern of recurrence or disease-free survival.

Purpose: To investigate, in a phase III randomized trial, whether postoperative external-beam irradiation to the standard pelvic field improves the recurrence-free interval and overall survival (OS) in women with Stage IB cervical cancers with negative lymph nodes and certain poor prognostic features treated by radical hysterectomy and pelvic lymphadenectomy., Methods and Materials: Eligible patients had Stage IB cervical cancer with negative lymph nodes but with 2 or more of the following features: more than one third (deep) stromal invasion, capillary lymphatic space involvement, and tumor diameter of 4 cm or more. The study group included 277 patients: 137 randomized to pelvic irradiation (RT) and 140 randomized to observation (OBS). The planned pelvic dose was from 46 Gy in 23 fractions to 50.4 Gy in 28 fractions., Results: Of the 67 recurrences, 24 were in the RT arm and 43 were in the OBS arm. The RT arm showed a statistically significant (46%) reduction in risk of recurrence (hazard ratio [HR] = 0.54, 90% confidence interval [CI] = 0.35 to 0.81, p = 0.007) and a statistically significant reduction in risk of progression or death (HR = 0.58, 90% CI = 0.40 to 0.85, p = 0.009). With RT, 8.8% of patients (3 of 34) with adenosquamous or adenocarcinoma tumors recurred vs. 44.0% (11 of 25) in OBS. Fewer recurrences were seen with RT in patients with adenocarcinoma or adenosquamous histologies relative to others (HR for RT by histology interaction = 0.23, 90% CI = 0.07 to 0.74, p = 0.019). After an extensive follow-up period, 67 deaths have occurred: 27 RT patients and 40 OBS patients. The improvement in overall survival (HR = 0.70, 90% CI = 0.45 to 1.05, p = 0.074) with RT did not reach statistical significance., Conclusions: Pelvic radiotherapy after radical surgery significantly reduces the risk of recurrence and prolongs progression-free survival in women with Stage IB cervical cancer. RT appears to be particularly beneficial for patients with adenocarcinoma or adenosquamous histologies. Circumstances that may have influenced the overall survival differences are considered.

Background: Both acute renal failure (ARF) and female sex are strongly associated with mortality after open-heart surgery. This study analyzes the effect of sex and race on the incidence of ARF after open-heart surgery and its influence on mortality., Methods: A total of 24,660 patients underwent open-heart surgery at the Cleveland Clinic Foundation (Cleveland, OH) from 1993 to 2000. The primary outcome was ARF defined as ARF requiring dialysis, 50% or greater decline in glomerular filtration rate (GFR) not requiring dialysis, or 50% or greater decline in GFR relative to baseline or requirement of dialysis. The secondary outcome was all-cause hospital mortality., Results: The overall frequency of ARF requiring dialysis after open-heart surgery was 1.82%. The frequency was greater in women (2.36%) than men (1.60%; P < 0.0001) and blacks (2.94%) than nonblacks (1.70%; P < 0.0001) by univariate analysis. By multivariate analysis, risk for ARF requiring dialysis in women was 1.61 (confidence interval [CI], 1.27 to 2.05; P < 0.0001), but race was not a risk factor. The overall postoperative mortality rate was 2.2%, and for patients with ARF requiring dialysis, it was 61.2% (women, 68.6% versus men, 56.5%; P = 0.01) with an odds ratio of 49.29, whereas in patients with ARF not requiring dialysis, it was 14.1% (women, 13.3% versus men 14.6%; P = 0.63) with an odds ratio of 7.18., Conclusion: Female sex is an independent risk factor for developing ARF after open-heart surgery. The influence of race on risk for ARF is less clear. Regardless of its definition, ARF is strikingly associated with a high risk for mortality.

Purpose: The endorectal advancement flap is a surgical procedure used in the treatment of anorectal and rectovaginal fistulas. There is a wide range of success rates published in the literature. This study was undertaken to examine the success rate of primary endorectal advancement flap in our own institution. We attempted to identify factors that influence the rate of healing., Methods: A retrospective review was performed on 105 patients (43 males) who underwent their first endorectal advancement flap at our institution between January 1, 1994, and June 30, 1999. Ninety-nine patients were available for follow-up. Sixty-two patients had anorectal and 37 had rectovaginal fistulas. The causes of fistula included cryptoglandular (48 patients), Crohn's disease (44), obstetric injury (5), trauma (1), and other (1)., Results: The median follow-up was 17.1 (range, 0.4-66.9) months. The median age was 42 (range, 16-78) years. Recurrence was seen in 36 patients (36.4 percent); thus, the primary rate of healing was 63.6 percent. Factors that were associated with higher rates of success were increased age (P = 0.011), greater body surface area (P = 0.012), history of incision and drainage of a perianal abscess preceding advancement flap (P = 0.010), previous placement of a seton drain (P = 0.025), and short duration of fistula (P = 0.003). Factors that negatively influenced the healing rate of the flap were the diagnoses of Crohn's disease (P = 0.027) and rectovaginal fistula (P = 0.002). Length of hospitalization, discharge on oral antibiotics, and the presence of a diverting stoma did not influence the rate of healing. Prednisone was associated with a distinct trend toward failure, with none of the patients on high-dose prednisone (greater than 20 mg/day) having achieved long-term healing. No fistulas recurred after a period of 15 months., Conclusion: The endorectal advancement flap is an effective method of repair for both anorectal and rectovaginal fistulas, even though the success rate may not be as optimistic as in some other published studies. Patient selection is imperative, realizing that a higher rate of failure may be present in Crohn's disease and rectovaginal fistulas. Control of sepsis before endorectal advancement flap with drainage of a perianal abscess and/or seton placement, whenever possible, is indicated.

Objective: To compare the cost-effectiveness of preoperative testing strategies in women with stress incontinence symptoms, as although urodynamic testing is used to improve the diagnostic accuracy in women with incontinence, the clinical and economic consequences of different levels of testing have not been evaluated., Materials and Methods: Decision analysis was used to evaluate basic office assessment (BOA) and urodynamic testing for women with stress incontinence symptoms who were candidates for primary surgical treatment. Costs were calculated using the Federal Register. Parameter estimates for the effectiveness of treatment for different diagnoses of incontinence were based on published reports. Incremental cost-effectiveness was defined as the cost in dollars per additional patient cured of incontinence., Results: Urodynamics did not improve the effectiveness of treatment; both strategies of a BOA and urodynamic testing resulted in a cure rate of 96% after initial and secondary treatments. The mean cost of care (including initial and secondary treatments and outcomes) was similar for the two strategies ($5042 for BOA, $5046 for urodynamic testing). With BOA reduced testing costs were balanced by increased costs for patients who failed the initial treatment. Under baseline assumptions, one additional cure of incontinence (incremental cost-effectiveness) using the urodynamic strategy cost $3847, compared with BOA. By sensitivity analyses, BOA was less costly than urodynamics when the prevalence of genuine stress incontinence was > or = 80%., Conclusion: These findings do not support the routine use of urodynamics before surgery in women likely to have genuine stress incontinence, and provide the justification for randomized trials of preoperative testing strategies.

Objective: The purpose of this study was to compare outcomes after anterior colporrhaphy with the use of 3 different surgical techniques., Study Design: One hundred fourteen women with anterior vaginal prolapse were randomly assigned to undergo anterior repair by one of 3 techniques: standard, standard plus polyglactin 910 mesh, or ultralateral anterior colporrhaphy. Before and after operation, patients underwent physical examination staging of prolapse; the International Continence Society system was used. Symptoms were assessed by questionnaire and visual analog scales. We defined "cure" as satisfactory (stage I) or optimal (stage 0) outcome at points Aa and Ba., Results: Of 114 patients who were originally enrolled, 109 patients underwent operation, and 83 patients (76%) returned for follow-up. Mean age (+/- SD) was 64.7 +/- 11.1 years. At entry, 7 patients (7%) had stage I anterior vaginal prolapse; 35 patients (37%) had stage II anterior vaginal prolapse; 51 patients (54%) had stage III anterior vaginal prolapse; and 2 patients (2%) had stage IV anterior vaginal prolapse. At a median length of follow-up of 23.3 months, 10 of 33 patients (30%) who were randomly assigned to the standard anterior colporrhaphy group experienced satisfactory or optimal anatomic results, compared with 11 of 26 patients (42%) with standard plus mesh and with 11 of 24 patients (46%) with ultralateral anterior colporrhaphy. The severity of symptoms that were related to prolapse improved markedly (preoperative score, 6.9 +/- 2.7; postoperative score, 1.1 +/- 0.8). Twenty-three of 24 patients (96%) no longer required manual pressure to void after operation., Conclusion: These 3 techniques of anterior colporrhaphy provided similar anatomic cure rates and symptom resolution for anterior vaginal prolapse repair. The addition of polyglactin 910 mesh did not improve the cure rate compared with standard anterior colporrhaphy.

We sought to determine whether institution of respiratory syncytial virus (RSV) practice guidelines decreased resource utilization for a heterogeneous population of children hospitalized with RSV bronchiolitis. Patients less than 24 months old with RSV bronchiolitis at a pediatric referral center were identified by retrospective chart review for consecutive RSV seasons. Before the guidelines were instituted patients were less likely to have a documented physician's assessment of response to albuterol, were more likely to have received supplemental oxygen and cardiorespiratory monitoring, and to be discharged on an albuterol regimen. Patients received more albuterol treatments. After the guidelines were in place fewer resources were utilized in the care of patients with RSV bronchiolitis. RSV practice guidelines may simplify and streamline the care of a heterogeneous population of children with bronchiolitis.

Objective: To identify the functional and anatomic outcomes in women who have surgery for pelvic organ prolapse with enterocele repair., Methods: Fifty-four women had surgery for pelvic organ prolapse which included enterocele repair. Preoperative and postoperative examinations were done by a research nurse, including a pelvic examination using the International Continence Society staging system and standardized questionnaires about bowel function, sexual function, and prolapse symptoms., Results: Fifty-four women had enterocele repairs as part of their surgery. Mean follow-up time was 16 months (range 6-29 months). Postoperatively five women were excluded from the analysis because of fluctuation in stage of prolapse over time. At the apex and posterior wall of the vagina, 33 women had stage 0 or I prolapse, and 16 had stage II prolapse. None had stage III or IV prolapse. Fifty-three percent of women had improvement in bowel function and 91% had improvement in vaginal prolapse symptoms. Functional outcomes were not significantly different in women with and without stage II prolapse at follow-up., Conclusion: Most women who had surgery for pelvic organ prolapse with enterocele repair reported improvement in vaginal prolapse symptoms. Functional outcomes did not differ significantly between women with stage 0 and I prolapse and women with stage II prolapse at the vaginal apex and posterior vaginal wall. This was an observational study and the lack of statistically significant findings could result from inadequate sample size; however, the observed differences were judged to be not clinically significant.

Objective: To determine the time to normal voiding in women after various surgical procedures for genuine stress urinary incontinence (GSUI) or urethral hypermobility., Methods: One hundred one women had bladder neck suspensions. Suprapubic catheters were used in 94 women and intermittent self-catheterization in seven to manage urinary retention after surgery. We used a standardized protocol to record days to adequate postoperative voiding. Univariable and multivariable regression analyses were used to determine clinical, urodynamic, and surgical factors that independently influenced time to adequate postoperative voiding., Results: Women met the criteria for adequate voiding a mean of 7.1 days after modified open Burch procedures (n = 43), 9.5 days after anterior colporrhaphies with suburethral plication (n = 24), and 19.1 days after vaginal wall sling procedures (n = 34). The type of bladder neck suspension was independently associated with increasing time to void (P =.001). Multivariable regression analysis determined other factors significantly associated with longer time to adequate postoperative voiding: advancing age, previous vaginal bladder neck suspension, increasing volume at first sensation on bladder filling, higher postvoid residual urine volume (preoperative), and postoperative cystitis. Detrusor pressure, abdominal straining on pressure flow voiding study, and other concurrent surgeries were not significantly associated with postoperative voiding time in this model., Conclusions: Time to adequate voiding after bladder neck suspension was influenced by type of surgical procedure, postoperative cystitis, and several demographic and urodynamic factors. This study does not support using pressure flow studies to predict women at risk of voiding dysfunction.

Objective: To characterize preoperative signs and symptoms in women with and without enteroceles., Methods: Three hundred ten women completed preoperative questionnaires and had prolapses graded according to the International Continence Society system. Signs and symptoms in 77 women (25%) with enteroceles confirmed at surgery were compared with those in 233 women without enteroceles. Comparisons were tested for statistical significance with chi(2) tests, Fisher exact tests, Wilcoxon rank-sum tests, and analysis of covariance., Results: Women with enteroceles were statistically significantly older (median 67 versus 59 years, P <.001) and more likely to be postmenopausal (88% versus 76%, P =.04). More women with enteroceles had histories of hysterectomies (76% versus 39%, P =.001) and vaginal prolapse repairs (24% versus 11%, P =.008). Women with enteroceles had more advanced prolapses at points Ap, Bp, and C (all P <.001) but not point D. There were no significant differences in symptoms related to bowel function (infrequent bowel movements, straining, manual evacuation, and fecal incontinence) in women with and without enteroceles. Women with enteroceles were more bothered by symptoms caused by vaginal prolapse than women without enteroceles, but not after we controlled for stage of prolapse., Conclusion: Women with enteroceles have more advanced apical and posterior vaginal prolapses than women without enteroceles, but do not differ from them in bowel function.

Objective: We sought to describe sexual function in women before and after surgery for either prolapse or urinary incontinence, or both., Study Design: Women completed questionnaires, and vaginal dimensions were measured before and at least 6 months after surgery for prolapse or incontinence. Comparisons were made with signed-rank tests or the McNemar test., Results: Eighty-one (49%) of 165 women were sexually active before and after surgery; their mean age was 54. 0 +/- 9.9 years. Mean frequency of intercourse did not change. Dyspareunia was reported by 6 (8%) women preoperatively and 15 (19%) women after surgery; dyspareunia persisted postoperatively in 1 woman, developed in 14, and resolved in 5 (P =.04). Dyspareunia occurred in 14 (26%) of 53 women after posterior colporrhaphy (P =. 01) and in 8 (38%) of 21 women who had Burch colposusupension and posterior colporrhaphy performed together (P =.02). Vaginal dimensions decreased slightly after surgery; however, this did not correlate with any change in sexual function. Preoperatively, 66 (82%) women were satisfied with their sexual relationships, compared with 71 (89%) who were satisfied postoperatively., Conclusion: Sexual function and satisfaction improved or did not change in most women after surgery for either prolapse or urinary incontinence, or both. However, the combination of Burch colposusupension and posterior colporrhaphy was especially likely to result in dyspareunia.

Objectives: Our aim was to compare urinary, lower gastrointestinal, and sexual function and to describe patients' expectations and satisfaction before and after hysterectomy., Study Design: Forty-three women completed questionnaires before and about 1 year after abdominal hysterectomy for benign gynecologic conditions. Symptoms related to urinary, lower gastrointestinal, and sexual function and satisfaction with treatment were assessed. To account for multiple comparisons, only P

Objectives: To evaluate the appropriateness of autologous blood (AB) transfusion during radical retropubic prostatectomy in relation to the cardiopulmonary risk of the patient., Methods: We reviewed the medical records of 100 patients with American Society of Anesthesiologists status I, II, or III who underwent radical retropubic prostatectomy under general or combined general and epidural anesthesia. All patients had donated 2 units (U) of autologous blood, received 0, 1, or 2 U of autologous blood perioperatively, and received no allogeneic blood. Patients were placed in three cardiopulmonary risk groups on the basis of risk factors or documented cardiopulmonary disease. The low-risk group was assigned a target discharge hematocrit of 24% or less; moderate-risk, 25% to 28%; and high-risk, 29% or greater. The appropriateness of transfusion was determined by whether patients' hematocrit was in their group's preassigned range at discharge., Results: On the basis of discharge hematocrit, significantly more low-risk patients underwent inappropriate transfusion than moderate-risk (64% versus 26%, P = 0.006) or high-risk (64% versus 13%, P = 0.001) patients. Seventy-five AB units were discarded and at least 53 U were inappropriately transfused. We found an increase in the number of units of autologous blood transfused when a larger estimated blood loss was reported (P < 0.001). The estimated charge for the units discarded and inappropriately transfused exceeded $12,000., Conclusions: Sixty-four percent of autologous blood units were discarded or inappropriately transfused during radical retropubic prostatectomy. Transfusion of autologous blood was not governed by cardiopulmonary risk stratification. If the decision to transfuse had been based on cardiopulmonary risk factors instead of estimated blood loss, fewer patients would have received autologous blood.

Objective: To identify independent risk factors for endometrial neoplasia in women with abnormal perimenopausal or postmenopausal bleeding and to use those factors to develop and test a predictive model., Methods: We conducted a case-control study of women with abnormal perimenopausal or postmenopausal bleeding who had endometrial samplings; cases had endometrial cancer or complex hyperplasia and controls had benign endometrial histologies. Multivariate logistic regression models identified factors associated with risks of endometrial neoplasia. The predictive abilities of our models and a published model were assessed using the area under receiver operating characteristic (ROC) curves, for which an area of 1.0 indicated perfect positive predictive ability and an area of 0.5 was expected by chance., Results: There were 57 cases of endometrial hyperplasia or cancer and 137 controls. Parity was related inversely (odds ratio [OR] 0.70; 95% confidence interval [CI] 0.56, 0.88; P = .002) and weight directly (OR 1.02 per kg; 95% CI 1.01, 1.04; P = .018) to the risk of endometrial neoplasia. Age (OR 1.04 per year; 95% CI 1.00, 1.08; P = .06) and diabetes (OR 3.50; 95% CI 0.99, 12.33; P = .052) were significant marginally. The area under the ROC curve for our model was 0.75, indicating moderate predictive ability; the area under the ROC curve for the published model was lower at 0.66., Conclusion: Current clinical predictive models based on case-control studies do not have sufficient predictive ability to determine if women with abnormal perimenopausal or postmenopausal bleeding should have diagnostic testing.

Objective: This study's objectives were to describe symptoms related to bowel dysfunction in women with uterovaginal prolapse and to compare these symptoms according to extent of posterior vaginal prolapse., Study Design: One hundred forty-three women completed a questionnaire assessment of bowel function and underwent standardized physical examination according to the International Continence Society's system for grading uterovaginal prolapse., Results: The mean age was 59.2 years (SD 11.8 years); 78% of the women were postmenopausal. According to the furthest extent of posterior vaginal prolapse at point Bp, 22 (15.5%) were in stage 0, 46 (32.4%) were in stage I, 50 (35.2%) were in stage II, 23 (16.2%) were in stage III, and 1 (0.7%) was in stage IV. Ninety-two percent of women reported having bowel movements at least every other day. When asked whether straining was required for them to have a bowel movement, 38 (26.6%) reported never or rarely, 71 (49.6%) reported sometimes, 20 (14.0%) reported usually, and 14 (9.8%) reported always. When asked whether they ever needed to help stool come out by pushing with a finger in the vagina or rectum, 98 (69.0%) reported never or rarely, 30 (21.1%) reported sometimes, 8 (5.6%) reported usually, and 6 (4.2%) reported always. Twenty-three women (16.1%) had fecal incontinence, with 11 having loss of control of stool less often than once a month and 12 having it more often than once a month. When asked whether to rate how much they were bothered by their bowel function on a scale of 1 to 10, with 1 being not at all and 10 being extremely, 51.7% of women chose 1 to 4, 20.3% chose 5 to 7, and 28% chose >/=8. There were no clinically significant associations between any of the questions related to bowel function and severity of posterior vaginal prolapse., Conclusion: Women with uterovaginal prolapse frequently have symptoms related to bowel dysfunction, but this is not associated with the severity of posterior vaginal prolapse.

Objective: To compare urinary, lower gastrointestinal (GI), and sexual function and to describe patients' expectations and satisfaction before and after hysterectomy.Methods: Forty-three women completed questionnaires before and about 1 year after abdominal hysterectomy for benign gynecologic conditions. Symptoms related to urinary, lower GI, and sexual function were assessed. Women responded with "agree," "disagree," or "neutral" to statements about treatment options, the decision for hysterectomy, expectations about surgery and recovery, and satisfaction with their relationship with their doctor and their treatment. Comparisons were made between preoperative and postoperative responses. Statistical significance was accepted for P =.002 to account for multiple comparisons.Results: The mean age was 45.4 +/- 6.7 years. Sixty percent were white, and 88% were premenopausal. The most common indication for hysterectomy was myomas in 76%. There were no statistically significant changes in urinary or bowel symptoms before and after hysterectomy with preoperative symptoms resolving in some women after surgery, and developing in others. Fewer women experienced abdominal bloating after hysterectomy than before. Frequency of intercourse and satisfaction with their sexual relationship did not change in the 34 sexually active women. The level of satisfaction with their treatment and their relationship with their doctor was very high.Conclusion: Women experience a high degree of satisfaction with treatment 1 year after abdominal hysterectomy for benign gynecologic conditions. Symptoms related to urinary, GI, or sexual function occur frequently before and after surgery, but hysterectomy does not result in consistent changes.

The purpose of this study was to determine the rate of progression of the degree of carotid stenosis and to determine the risk of continued observation in a group of asymptomatic patients with moderate stenosis of at least one internal carotid artery. Between 1989 and 1994, 2130 patients were found to have 60-79% stenosis of at least one internal carotid artery following a duplex ultrasound examination in the authors' vascular laboratory. Of these, 465 patients (255 men, 210 women) were asymptomatic and had more than one ultrasound examination, and they form the basis of this retrospective review. The mean +/- SD age was 68.8 +/- 9.0 years. The mean +/- SD number of ultrasound examinations was 3.1 +/- 1.4 (range 2-11). The mean +/- SD follow-up was 24.4 +/- 17.6 months (range 2-79 months). Over the period of follow-up 72 patients (15.5%) progressed to 80-99% stenosis (n = 71) or to occlusion (n = 1). The estimated percentage of patients who progressed by life table methods were 5 +/- 1% at 1 year, 11 +/- 2% at 2 years and 20 +/- 3% at 3 years. There was no statistically significant difference in the rate of progression in men compared with women. Twenty-one patients had a late ipsilateral TIA or stroke. Five out of 72 patients (6.9%) who progressed had a late ipsilateral TIA compared with nine out of 393 patients (2.3%) who did not progress (estimated risk ratio 16.1, P = 0.0001). Four out of 72 patients (5.6%) who progressed had a late ipsilateral stroke compared with three out of 393 patients (0.76%) who did not progress (estimated risk ratio 23.6, p = 0.0002). The cumulative ipsilateral stroke rate using life table methods was 0.22% at 1 year, 1% at 2 years and 2.4% at 3 years. In a large cohort of asymptomatic patients, the frequency of progression of 60-79% internal carotid artery stenosis was 5% at 1 year, 11% at 2 years and 20% at 3 years. Patients who progressed were more likely to have symptoms, but the rate of unheralded stroke was relatively low over a 3-year time period. Surveillance carotid ultrasound examinations should be performed in patients with moderate carotid stenosis. Because of the lack of clear benefit, carotid endarterectomy for asymptomatic 60-79% internal carotid artery stenosis cannot be justified.

Objective: Our goal was to compare the predicted outcomes and costs of two diagnostic algorithms for postmenopausal bleeding., Study Design: Two algorithms for postmenopausal bleeding were developed, one with vaginal ultrasonography and the other with office endometrial biopsy as the first test. Literature review was performed to estimate the probability of either an abnormal result of ultrasonography or a nondiagnostic biopsy, or both. Cost and sensitivity analyses were performed., Results: Estimated probability of a nondiagnostic endometrial biopsy was 28%, and estimated probability of an abnormal result of vaginal ultrasonography (either inconclusive or endometrial thickness > 4 mm) was 55%. Cost analysis showed that vaginal ultrasonography as the first diagnostic test cost $230 per patient on average compared with $244 for endometrial biopsy, with savings ranging from $14 to $20 per patient over a wide range of possible values for estimated parameters., Conclusion: Vaginal ultrasonography costs slightly less than office endometrial biopsy as the first test in the diagnostic evaluation of women with postmenopausal bleeding.

Objective: To determine the prevalence of hydronephrosis in patients undergoing surgery for pelvic organ prolapse and to determine whether hydronephrosis is associated with the type and severity of prolapse., Methods: The charts of 375 consecutive patients undergoing surgery for pelvic organ prolapse at the Cleveland Clinic Foundation between January 1, 1990, and December 31, 1993 were reviewed. Preoperative renal ultrasounds and intravenous pyelograms (IVP) were evaluated for hydronephrosis based on the final diagnosis established by the radiologists. The severity of prolapse was determined from the preoperative office examination or from the examination under anesthesia at the time of surgery., Results: Of 375 patients, 323 had either a preoperative renal ultrasound or IVP. The mean age was 66.0 +/- 10.2 years (range 35-93) and median parity was 3.0 (range 0-10). Of the 323 patients, 25 (7.7%, 95% confidence interval 5, 11) had hydronephrosis. Thirteen patients (4.0%) had mild hydronephrosis, nine (2.8%) had moderate hydronephrosis, and three (0.9%) had severe hydronephrosis. The prevalence of hydronephrosis increased with increasing severity of prolapse. Two patients with hydronephrosis had evidence of renal insufficiency (creatinine > or = 1.6), and both had severe bilateral hydronephrosis and complete procidentia. The prevalence of hydronephrosis was lower in patients with vaginal vault prolapse versus uterine prolapse (3.9% compared with 12.6%, P < .01),, Conclusion: The prevalence of hydronephrosis in patients undergoing surgery primarily for pelvic organ prolapse is low, increases with worsening pelvic organ prolapse, and is lower in patients with vaginal vault prolapse that in those with uterine prolapse.

Purpose: This study reports the initial and late results of percutaneous transluminal angioplasty (PTA) and intravascular stenting for atherosclerotic occlusive disease of the iliac arteries., Methods: The preprocedural and postprocedural clinical records, arteriograms, segmental limb pressure measurements (ankle-brachial [ABI] and thigh-brachial [TBI] indexes), and pulse volume recordings of 288 patients who underwent PTA and primary stenting of the common iliac (354, 69.4%) and external iliac (156, 30.6%) arteries were reviewed. Initial and late clinical, hemodynamic, and angiographic success were assessed by objective criteria. Data on patients who underwent unsuccessful attempts at iliac stent placement are unavailable; results are not reported on an intent-to-treat basis., Results: Clinical follow-up data (mean, 11.9 months) are available for 268 of 288 patients (93.1%) and for 394 of 424 limbs (92.9%). The initial success rates, as determined by TBI, ABI, and clinical limb status, were 90.2%, 87.8%, and 74.6%, respectively. The Kaplan-Meier estimates of angiographic patency (101 arteries) were 96%, 81%, and 73% at 6, 12, and 24 months. Cumulative patency rates were 84%, 76%, and 57% on the basis of TBI, ABI, and clinical limb status at 24 months. Factors associated with initial success included the need for multiple stents (p = 0.0001), a higher degree of initial stenosis (p = 0.0001), lower severity of baseline ischemia (p = 0.007), younger age (p = 0.0015), and the preprocedural patency of the ipsilateral superficial femoral artery (p = 0.002). A higher degree of initial stenosis (p < 0.001) and superficial femoral artery patency (p = 0.004) were also associated with late success., Conclusions: PTA and stenting of the iliac arteries is associated with reasonable angiographic, hemodynamic, and clinical success. The outcome is favorably affected by higher initial severity of stenosis and greater extent of disease, lower severity of baseline ischemia, younger age, and by patency of the ipsilateral superficial femoral artery.

Purpose: Atherosclerotic carotid artery stenosis (CAS) is the most common cause of stroke in young adults. We retrospectively studied clinical characteristics of premature CAS and the safety and durability of carotid endarterectomy (CEA) in 56 patients 50 years of age or younger (mean, 46.4 years; 34 (60%) males; group I) who underwent primary CEA at the Cleveland Clinic between 1983 and 1993., Methods: The patients were identified from the Vascular Surgery Registry and were compared with 202 randomly selected patients 60 years of age and older (mean, 69.3 years; group II) who were frequency-matched by gender and the year of primary CEA. Carotid shunting was used routinely, and the arteriotomy was patched in the majority of cases. Patients were followed-up for mean of 47.2 months (group I) and 46.0 months (group II)., Results: No significant differences were found in the indications for CEA (symptomatic CAS, 49% in group I vs 48% in group II) or the prevalence of diabetes, coronary diseases, and lower extremity arterial disease. Younger adults were more likely to have a history of smoking (93% vs 76%; p = 0.005), hypertension (71% vs 52%; p = 0.006), premature menopause (57% vs 18%; p < 0.001) and had lower levels of high-density lipoprotein cholesterol (p = 0.03). There were no in-hospital deaths. Perioperative strokes in the distribution of the operated artery occurred within 24 hours in one younger patient (1.8%) and in one older patient (0.5%). This was attributed to early carotid thrombosis in the young patient. Major late postoperative neurologic complications were documented in one young patient (1.8%) and six older patients (3%). Patients in group I were at significantly higher risk for recurrent carotid stenosis (risk ratio, 3.1; 95% confidence interval [CI], 1.3 to 7.3; p = 0.010); younger individuals remained at significantly higher risk for recurrent stenosis even after adjusting for smoking and hypertension (risk ratio, 3.7; 95% CI, 1.5 to 9.4; p = 0.006). By life-table analysis, younger adults tended to have a higher rate of late reoperations (p = 0.065)., Conclusions: CEA can be safely performed in young adults with premature CAS, although younger individuals appear to have higher rates of recurrent carotid stenosis compared with older counterparts.

Objectives: To provide a risk-to-benefit analysis of open staging pelvic lymph node dissection (PLND) for prostate cancer., Methods: The medical records of all patients presenting with prostate cancer from July 1989 to April 1994 were reviewed. A total of 245 patients with clinically localized disease were selected to undergo radical retropubic prostatectomy (RRP) preceded by open PLND. Univariate and multivariate analyses were performed to evaluate the predictive value of the preoperative serum prostate-specific antigen (PSA) concentration, clinical stage, and Gleason score with regard to final nodal status. The cost and morbidity associated with PLND in the setting of RRP was also defined., Results: Overall, only 16 patients (6.5%) had lymph node metastases. Lymph node involvement correlated significantly with elevated serum PSA values (P = 0.0001), high Gleason score (P = 0.0022), and advanced clinical stage (P = 0.0001). Lymph node metastases were particularly uncommon in patients with nonpalpable tumors (1 of 67 [1.5%]), PSA values less than 10 (2 of 154 [1.3%]), and Gleason score less than 6 (1 of 26 [3.8%]). Overall, 179 patients (73.1%) presented with at least one or more of these favorable characteristics, and only 4 (2.2%) had lymph node involvement. Complications related to the lymphadenectomy occurred in 10 patients (4.1%). The cost per metastasis diagnosed in patients with low-risk characteristics was approximatley $43,600., Conclusions: An open staging PLND may no longer be justified on a routine basis in patients undergoing radical retropubic prostatectomy.

To evaluate the function of the Carpentier-Edwards pericardial valve in the aortic position, we analyzed the results of 310 aortic valve replacements performed between 1982 and 1985. Mean age was 64.2 +/- 10.8 years (range 22 to 95 years); 190 patients (61.3%) were male patients. There were 18 hospital deaths (5.8%), and none were valve related. Follow-up of the 292 survivors was 100% complete at a mean of 7.8 +/- 2.9 years; 2290 patient-years of follow-up were available for analysis. There were 133 late deaths (45.5%). Actuarial survivals at 5 and 10 years were 82.5% and 45.9%, respectively. The 10-year actuarial freedom from events was 88.7% +/- 2.1% for thromboembolism, 90.9% +/- 1.8% for hemorrhage, 94.3% +/- 1.6% for endocarditis, and 91.2% +/- 2.6% for structural deterioration. The 153 hospital survivors 65 years of age or older had an extremely low incidence of structural valve deterioration, with only four explants and 95.5% actuarial freedom from explantation at 10 years, and a linearized rate of 0.3 +/- 0.2 per patient-year compared with 88.6% and 0.7 +/- 0.2 for patients younger than 65 years of age. Twelve valves were explanted for structural deterioration. Of these, 11 (93%) had leaflet calcification causing stenosis and one had a wear-related leaflet tear. The Carpentier-Edwards pericardial valve has a low incidence of valve-related complications. The freedom from structural valve deterioration is low at 10 years, particularly in patients 65 years of age and older.

Objective: To determine the utility of duplex ultrasound scanning of the renal arteries in identifying patients with renal artery stenosis of 60% or more and in excluding patients with either normal renal arteries or renal artery stenosis of less than 60%., Design: A prospective, blinded study., Setting: Large tertiary referral center., Patients: 102 consecutive patients (44 men and 58 women with a mean age [+@- SD] of 63.3 +/- 13.4 years) who had both duplex ultrasound scanning of the renal arteries and renal arteriography. All patients who were studied had hypertension that was difficult to control, unexplained azotemia, or associated peripheral vascular disease (alone or in combination), giving them a high pretest likelihood of renovascular disease., Main Outcome Measurements: Peak systolic and end diastolic velocities, renal-aortic ratios, resistive index, and kidney sizes., Results: Sixty-two of 63 arteries with stenosis of less than 60% using arteriography were correctly identified by duplex ultrasound scanning. Thirty-one of 32 arteries with 60% to 79% stenosis using arteriography were correctly identified as having 60% to 99% stenosis on duplex ultrasound, whereas 67 of 69 arteries with 80% to 99% stenosis on arteriography were correctly identified as having 60% to 99% stenosis on ultrasound. Twenty-two of 23 arteries with total occlusion on arteriography were correctly identified by duplex ultrasound. The overall sensitivity of duplex ultrasound compared with arteriography was 0.98, the specificity was 0.98, the positive predictive value was 0.99, and the negative predictive value was 0.97., Conclusion: Duplex ultrasound scanning of the renal arteries is an ideal screening test because it is noninvasive and can predict the presence or absence of renal artery stenosis with a high degree of accuracy.

Existing methods for the analysis of clustered, ordinal data are inappropriate for certain applications. We propose latent variable models for clustered ordinal data which are derived as natural extensions of latent variable models for clustered binary data (Qu, Williams, Beck, and Medendorp, 1992. Biometrics 48, 1095-1102). These models can be applied to repeated measures data, familial data, longitudinal data, and data with both cluster specific and occasion specific covariates with a wide range of correlation structures.

To determine if differences in early and late outcome after angioplasty were related to gender or body surface area, 5,000 consecutive patients (1,274 women and 3,726 men) were studied. Baseline variables, procedural outcome, and long-term and event-free survival were assessed. Baseline variables included age, history of hypertension, diabetes mellitus, heart failure, myocardial infarction, prior angioplasty or bypass surgery, familial coronary disease, Canadian heart classification, extent of angioplasty, left ventricular function, and body surface area. Overall and event-free survival (freedom from infarction, repeat angioplasty, bypass surgery and death) were assessed at follow-up. The results showed that, compared with men, women were older (p < 0.0001), had a higher prevalence of diabetes (p < 0.0001), familial coronary disease (p = 0.002), hypertension (p < 0.0001), prior infarction (p = 0.004), and more involvement of the anterior descending artery (p = 0.017). Whereas men had similar extents of angioplasty and worse left ventricular function (p = 0.012), women more often had unstable angina (p < 0.0001). The success rates were similar, yet women had a higher procedural mortality (1.1% women, 0.3% men, p = 0.001). When corrected for body surface area, however, women were at no greater risk than men. Follow-up was complete for 97.4% of patients (mean 4 +/- 2 years). Event-free survival was significantly better in women, even after correcting for body surface area. Men were at higher risk for late death and repeat angioplasty on follow-up.(ABSTRACT TRUNCATED AT 250 WORDS)

Objectives: We attempted to develop a statistical model to facilitate risk stratification for long-term outcome after elective coronary angioplasty., Background: Our understanding of factors related to long-term outcome after coronary angioplasty is limited. Adequate assessment of risk indexes could potentially lead to more appropriate use of percutaneous revascularization., Methods: We studied 5,000 consecutive patients and assessed 19 clinical and anatomic variables as predictors of long-term event-free survival. Events were defined as death of any cause, myocardial infarction, bypass surgery or repeat percutaneous transluminal coronary angioplasty. Cox proportional hazards models were used to develop an equation for predicting event-free survival in a subset of 4,000 patients. The equation was validated with the remaining 1,000 patients. Variables that were significantly associated with an adverse outcome in the multivariate model included age > 60 years, extent of disease, Canadian Cardiovascular Society functional class, previous coronary angioplasty, male gender, history of diabetes mellitus, history of hypertension and history of congestive heart failure., Results: The statistical model was used to develop a simplified scoring system, and the patients were assigned to three risk subgroups. Event-free survival curves for the three groups were significantly different (p = 0.0001). High risk patients had worse outcomes for each of the end points compared with low and moderate risk patients (p < 0.02)., Conclusions: We demonstrated that clinical and anatomic variables can be used to risk-stratify long-term outcome after angioplasty, that a simplified scoring system can be used for risk stratification and that high risk patients have a low event-free survival.

A controversial point in the management of patients undergoing anterior cervical discectomy is whether an interbody bone graft should be used. Proponents of interbody grafting claim that without a graft, the disc height and the area of the foramina at that level will decrease postoperatively with the potential for persistent symptoms and/or the development of a radiculopathy. Using a two-dimensional digital planimeter, we measured the cross-sectional area (cm2) of cervical foramina on preoperative and postoperative oblique films in patients undergoing anterior cervical discectomy. Group A patients underwent the insertion of an interbody graft after the discectomy; Group B patients did not. Our results indicate that in all the patients in Group A, there was a statistically significant increase in the area of the foramina (P < 0.001) and in Group B, a statistically significant decrease (P = 0.0005). However, when the absolute change in magnitude of the foramina was measured, without respect to an increase or decrease, there was no statistically significant difference (P > 0.8). There was no statistically significant difference (P = 1.000) in the outcome between the two groups. From an anatomical standpoint, our data support the insertion of an interbody graft if the surgeon wishes to increase the area of the foramen. However, the overall magnitude of change is not significant, which may be a factor in why the clinical outcome is similar in both groups.

Study Objective: We set out to determine if there is a significant difference in the morbidity and mortality between the anergic and reactive groups., Design: A retrospective study of the heart transplant population was performed., Setting: We studied the results of delayed hypersensitivity skin tests (DHSTs) in all cardiac transplant recipients at the Cleveland Clinic between May 1985 and November 1991 to determine whether DHST results were of prognostic significance., Results: Preoperative skin testing was reactive to two or more antigens in 90 of the 127 patients whose DHSTs were interpretable, and the remainder were anergic. Anergic response was associated with increased bilirubin and decreased albumin levels, but gender, race, primary underlying heart disease, age at transplantation, creatinine level, hematocrit, glucose level, and ejection fraction were not related to anergy. Anergic patients had significantly higher mortality at 30, 60, and 90 days after transplantation, but long-term mortality was not significantly different from patients reactive on DHSTs (p = 0.267)., Conclusion: We conclude that the DHSTs provide useful information regarding risk of early mortality after heart transplantation.

Purpose: Between 1977 and 1991, 405 patients with atherosclerotic occlusive disease of the superficial femoral artery underwent clinical as well as noninvasive laboratory evaluation and were recommended for nonoperative treatment., Methods: Limbs with uncorrected aortoiliac occlusive disease, aneurysmal degeneration, or previous femoropopliteal bypass were excluded, leaving 568 involved extremities. Complete follow-up, which forms the basis for this report, was available in 377 patients (93%) with 520 limbs (93%). Patients were monitored for a minimum period of 2 years (range, 24 to 164 months; median, 86 months). During the surveillance period 45 limbs (8.6%) in 42 patients (11.1%) required arterial intervention. This entailed operation in 39 cases and endovascular treatment in six cases. With use of life-table analysis, the risk for intervention was found to be 11% at 5 years and 14% at 10 years. A total of 14 limbs (2.7%) in 14 patients (3.7%) ultimately required major limb amputation, either after failed bypass (8 patients) or as a primary procedure (6 patients)., Results: Analysis of risk factors revealed that female sex (p = 0.04), chronic renal failure (p = 0.0001), diabetes mellitus (p = 0.0011), history of contralateral femoropopliteal bypass (p = 0.0005), level of disease (p = 0.003), and entry ankle/brachial index less than 0.50 (p = 0.004) were associated with an increased risk over time for intervention. Other factors, including age, current or prior smoking history, hypertension, and the presence of coronary artery disease or cerebrovascular disease failed to reach statistical significance., Conclusions: These data support the continued conservative approach to surgery for patients with superficial femoral artery occlusive disease without limb-threatening symptoms. Patients with multilevel disease, lower ankle/brachial index, a history of contralateral femoropopliteal bypass, chronic kidney failure, or diabetes mellitus are at increased risk and should be monitored more closely.

As the ages of patients undergoing cardiac operations have increased, noncardiac causes of death have increased. To identify these causes of death, we analyzed the autopsy findings in 221 patients undergoing myocardial revascularization or valve operations between 1982 and 1989. Mean age was 65.6 +/- 9.5 years and the range was from 32 to 94 years; 130 patients (58.8%) were male. Autopsies were complete in 129 patients (58.4%) and limited to the chest and abdomen in the remainder. Embolic disease was identified in 69 patients (31.2%). Atheroemboli or abnormalities consistent with atheroemboli were identified in 48 patients (21.7%). Fourteen patients had thromboembolism and 7 had disseminated intravascular coagulation. The prevalence of atheroembolic disease increased dramatically from 4.5% in 1982 to 48.3% in 1989 (p = 0.001). Atheroembolic disease was found in the brain in 16.3% of patients, spleen in 10.9%, kidney in 10.4%, and pancreas in 6.8%. Thirty (62.5%) of the 48 patients had multiple atheroembolic sites. Atheroemboli were more common in patients undergoing coronary artery procedures (43/165; 26.1%) than in those undergoing valve procedures (5/56; 8.9%) (p = 0.008). There was a high correlation of atheroemboli with severe atherosclerosis of the ascending aorta. Atheroembolic events occurred in 46 of 123 patients (37.4%) with severe disease of the ascending aorta but in only 2 of 98 patients (2%) without significant ascending aortic disease (p less than 0.0001). Forty-six of 48 patients (95.8%) who had evidence of atheroemboli had severe atherosclerosis of the ascending aorta. There was a direct correlation between age, severe atherosclerosis of the ascending aorta, and atheroemboli. Incremental risk factors for atheroembolic are peripheral vascular disease and severe atherosclerosis of the ascending aorta.

Between May 1966 and June 1991, 129 patients underwent surgical repair of thoracoabdominal aneurysms, with an overall 30-day mortality rate of 35%. In 75 operations (58%) performed electively, 11 deaths (15%) occurred, and in 54 cases (42%) of either symptomatic or ruptured aneurysms 34 deaths (63%; p less than 0.001) occurred. No one survived among six patients with preoperative hypotension (less than 90 mm Hg) or cardiac arrest. In 16 patients (12%) the etiology of aneurysms was a result of chronic aortic dissection, and the mortality rate in this subgroup was 44%. In the remaining 113 patients (88%) where the etiology was atherosclerosis, 38 deaths occurred (34%; p = 0.433). Spinal cord ischemia occurred in 25 cases (21%) among 116 patients who survived operation. Partial ischemia occurred in six cases (25%), and complete paraplegia occurred in the remainder. Complete and partial paraplegia occurred in 16 of 42 cases (38%) when all of the thoracic aorta was replaced (Crawford groups I, II) and in 9 of 74 cases (12%) when only the abdominal or lower thoracic aorta was replaced (Crawford groups III, IV; p = 0.016). Other complications included myocardial infarction (14 cases, 11%), respiratory failure (46 cases, 36%), and renal failure (33 cases, 27%). The major prospect for improved early survival of patients with thoracoabdominal aneurysms seems to be early detection and elective repair before the occurrence of symptoms.

Objective: To determine the clean surgical wound infection rate for breast procedures and the risk factors predisposing patients to these infections., Design: A survey study., Setting: Oncology center., Patients: A consecutive sample of adult female patients who underwent surgical breast procedures for suspected carcinoma of the breast. Patients undergoing excisional biopsy, lumpectomy, or mastectomy from January 1985 to January 1987 were included in the study., Intervention: Clean surgical wound infection rates were derived overall and for each procedure type. The medical records of all patients were then reviewed to extract data on patient characteristics and operative information in order to assess the risk factors for infection., Results: Among the breast procedures performed on 448 patients, the overall clean surgical wound infection rate was 8.7% (39/448). The clean surgical wound infection rate for each procedure type was as follows: biopsy 2.3%, lumpectomy 6.6%, and mastectomy 19%. In addition to the type of procedure, factors significantly (p less than .05) associated with the development of clean surgical wound infection in the univariate analysis included: presence of surgical drains (p less than .01); closed suction drainage (odds ratio [OR] = 16.5, 95% confidence interval [CI95] = 5.0-54.7); location of the drain (OR = 3.3, CI95 = 1.7-6.6); prolonged preoperative stay (OR = 1.2, CI95 = 1.0-1.5); length of surgery (OR = 2.2, CI95 = 1.7-3.0); and greater mean age (OR = 1.6, CI95 = 1.2-2.1)., Conclusion: Clean surgical wound infections are not uncommon in patients undergoing breast procedures. Factors relating to both the patient and operative techniques contribute to the clean surgical wound infection rate. Further consideration should be given to perioperative antibiotic prophylaxis for selected breast procedures, and the role of surgical drains should be reassessed.

To investigate the effect of diabetes on stroke after myocardial infarction (MI), we studied consecutive MI patients admitted to the coronary-care unit prospectively, and compared diabetics with non-diabetics. Seven per cent (11/148) of diabetics and 3% (8/297) of non-diabetics had a stroke within 1 month after MI (P = 0.020). Previous stroke and hypertension were significant risk factors for stroke after MI in diabetics, but there were no significant risk factors in non-diabetics. Hypertension was more frequent in diabetics with (12/14; 86%) than in diabetics without (63/134; 47%) a previous stroke (P less than 0.025). Severe hypotension was more frequent in diabetics (9/11) than in non-diabetics with stroke after MI (0/8) (P = 0.002). We conclude that hypertension is a risk factor for stroke after MI in diabetics, and that may be at risk for hypotensive stroke after MI. Stroke after MI may be more frequent in diabetics than in non-diabetics.

Eighty-three children with a chief complaint of nocturnal enuresis and no history of urinary tract infection (UTI) were prospectively evaluated with a contrast voiding cystourethrogram (VCUG). The following four historical details of presentation were noted: primary vs. secondary enuresis, daytime wetting, urgency, and frequency. Each of these four symptoms were treated as a dichotomous variable, and the prognostic value with respect to vesicoureteral (VUR) reflux was assessed using a linear logistic regression model. Nineteen ureters in 13 patients (16%) demonstrated VUR: grade I, 7 ureters; grade II, 5 ureters; grade III, 3 ureters; grade IV, 4 ureters; and grade V, 0 ureters. Three patients demonstrated renal scarring (16%) and 2 patients underwent surgery. The linear regression analysis revealed that no one symptom, group of symptoms, or absence of all four symptoms segregated those patients likely to have reflux with statistical validity. One of 6 children, therefore, who present with nocturnal enuresis and sterile urine will have reflux. Screening these children with a VCUG should be considered.

Lymphokine-activated killer (LAK) cells were generated from splenocytes of rats bearing a weakly immunogenic Dunning prostate tumor (R-3227 AT-3) and activated with recombinant interleukin-2 (rIL-2). The maximal LAK activity was obtained from splenocytes of rats bearing tumors for 10 to 14 days after incubation with 1000 U/ml./day of rIL-2 for five to eight days. The majority of these LAK cells expressed high levels of asialo GM1 (89%), laminin (83%), OX-19 (80%) and OX-8 (88%) surface markers. LAK cells exhibited higher cytotoxicity to rat prostate tumor cells and mouse lymphoma in vitro than to other non-prostate tumor cells or normal rat splenocytes and thymocytes. Splenocytes of rats bearing prostate tumors have higher LAK activity than normal splenocytes. The Winn type assay showed that Dunning prostate tumor growth was inhibited effectively by LAK cells at a tumor cell:LAK cell ratio of 1:50. The therapeutic efficacy of LAK cells in the treatment of primary solid prostate tumors and pulmonary metastases of Dunning rats was evaluated. LAK cells in combination with rIL-2 showed a greater therapeutic benefit in 1) prevention of prostate tumor metastases to lung, 2) retardation of the primary tumor growth, 3) regression of spontaneously established pulmonary metastases, and 4) prolongation of survival as compared to untreated controls or those groups treated with LAK cells or rIL-2 alone. The results of this study indicate that the conjunctive therapeutic approach of using surgical therapy to remove primary solid tumors followed by adoptive immunotherapy with LAK cells plus in vivo administration of IL-2 may be potentially valuable in the treatment of prostate tumors, particularly for the spontaneous pulmonary metastases.

From a series of 1495 patients with primary cutaneous malignant melanoma (PCMM), 26 patients (1.73%) had multiple primary cutaneous malignant melanoma (MPCMM). This report describes the attributes and survival patterns in this small, but important, subgroup of patients with PCMM. Of 26 patients, 23 had two primaries, two had three primaries, and one had six primaries. Five patients had synchronous and 21 patients had metachronous MPCMM. The median interval between the occurrence of the first and subsequent PCMM in these patients was 1.93 years. The estimated 5-year survival rate from the first melanoma was 83.5%; that from the last melanoma was 53.1%. In summary, MPCMM is a distinct biologic phenomenon. A second or subsequent malignant melanoma should be treated like a primary melanoma.