Comparison of robotic-assisted minimally invasive esophagectomy versus minimally invasive esophagectomy: A propensity-matched study from a single high-volume institution.

OBJECTIVE: Robotic-assisted minimally invasive esophagectomy accounts for a growing proportion of esophagectomies, potentially due to improved technical capabilities simplifying the challenging aspects of standard minimally invasive esophagectomy. However, there is limited evidence directly comparing both operations. The objective is to evaluate the short-term and long-term outcomes of robotic-assisted minimally invasive esophagectomy in comparison with the minimally invasive esophagectomy approach for patients with esophageal cancer over a 7-year period at a high-volume center. The primary end points of this study were overall survival and disease-free survival. Secondary end points included operation-specific morbidity, lymph node yield, readmission status, and in-hospital, 30-day, and 90-day mortality. METHODS: Patients who underwent robotic-assisted minimally invasive esophagectomy or standard minimally invasive esophagectomy over a 7-year period were identified from a prospectively maintained database. Inclusion criteria were patients with stage I to III disease, operations performed past the learning curve, and no evidence of scleroderma or cirrhosis. A 1:3 propensity match (robotic-assisted minimally invasive esophagectomy:minimally invasive esophagectomy) for multiple clinical covariates was performed to identify the final study cohort. Perioperative outcomes were compared between the 2 operations. RESULTS: A total of 734 patients undergoing minimally invasive esophagectomy (n = 630) or robotic-assisted minimally invasive esophagectomy (n = 104) for esophageal cancer were identified. After exclusions and matching, a total cohort of 246 patients undergoing robotic-assisted minimally invasive esophagectomy (n = 65) or minimally invasive esophagectomy (n = 181) were identified. There was no difference in overall survival (P = .69) or disease-free survival (P = .70). There were no significant differences in rates of major morbidity: pneumonia (17% vs 17%, P = .34), chylothorax (8% vs 9%, P = .95), recurrent laryngeal nerve injury (0% vs 1.5%, P = 1), anastomotic leak (5% vs 4%, P = .49), intraoperative complications (9% vs 8%, P = .73), or complete resection rates (99% vs 96%, P = .68). There was no difference in in-hospital (P = .89), 30-day (P = .66) or 90-day mortality (P = .73) between both cohorts. The robotic-assisted minimally invasive esophagectomy cohort yielded a higher median lymph node harvest in comparison with the minimally invasive esophagectomy cohort (32 vs 29, P = .02). CONCLUSIONS: Robotic-assisted minimally invasive esophagectomy may improve lymphadenectomy in patients undergoing esophagectomy for cancer. Minimally invasive esophagectomy and robotic-assisted minimally invasive esophagectomy are otherwise associated with similar mortality, morbidity, and perioperative outcomes. Further prospective study is required to investigate whether improved lymph node resection may translate to improved oncologic outcomes.

Sternotomy Wound Infiltration With Liposomal Versus Plain Bupivacaine for Postoperative Analgesia After Elective Cardiac Surgery.

OBJECTIVES: Poor pain control after cardiac surgery can be associated with postoperative complications, longer recovery, and development of chronic pain. The authors hypothesized that adding liposomal bupivacaine (LB) to plain bupivacaine (PB) will provide better and long-lasting analgesia when used for wound infiltration in median sternotomy. STUDY DESIGN: Prospective, randomized, and double-blinded clinical trial. SETTING: Single institution, tertiary care university hospital. PARTICIPANTS: Adult patients who underwent elective cardiac surgery through median sternotomy. INTERVENTIONS: A single surgeon performed wound infiltration of LB plus PB or PB into the sternotomy wound, chest, and mediastinal tube sites. MEASUREMENTS AND MAIN RESULTS: Patients were followed up for 72 hours for pain scores, opioid consumption, and adverse events. Sixty patients completed the study for analysis (LB group [n = 29], PB group [n = 31]). Patient characteristics, procedural variables, and pain scores measured at specific intervals from 4 hours until 72 hours postoperatively did not reveal any significant differences between the groups. Mixed-model regression showed that the trend of mean pain scores at movement in the LB group was significantly (p = 0.01) lower compared with the PB group. Opioid consumption over 72 hours was not significantly different between the 2 groups (oral morphine equivalents; median [interquartile range], 139 [73, 212] mg in LB v 105 [54, 188] mg in PB, p = 0.29). Recovery characteristics and adverse events were comparable. CONCLUSIONS: LB added to PB for sternotomy wound infiltration during elective cardiac surgery did not significantly improve the quality of postoperative analgesia.

Activity-Based Cost Analysis of Robotic Anatomic Lung Resection During Program Implementation.

BACKGROUND: While robotic-assisted lung resection has seen a significant rise in adoption, concerns remain regarding initial programmatic outcomes and potential increased costs. We present our initial outcomes and cost analysis since initiation of a robotic lung resection program. METHODS: Patients undergoing either video-assisted thoracoscopic lobectomy or segmentectomy (VATS) or robotic-assisted lobectomy or segmentectomy (RALS) between August of 2014 and January of 2017 underwent retrospective review. Patients underwent 1:1 propensity matching based on preoperative characteristics. Perioperative and 30-day outcomes were compared between groups. Detailed activity-based costing analysis was performed on individual patient encounters taking into effect direct and indirect controllable costs, including robotic operative supplies. RESULTS: There were no differences in 30-day mortality between RALS (n = 74) and VATS (n = 74) groups (0% vs 1.4%; P = 1). RALS patients had a decreased median length of stay (4 days vs 7 days; P < .001) and decreased median chest tube duration (3 days vs 5 days, P < .001). Total direct costs, including direct supply costs, were not significantly different between RALS and VATS ($6621 vs $6483; P = .784). Median total operating costs and total unit support costs, which are closely correlated to length of stay, were lower in the RALS group. Overall median controllable costs were significantly different between RALS and VATS ($16,352 vs $21,154; P = .025). CONCLUSIONS: A potentially cost-advantageous robotic-assisted pulmonary resection program can be initiated within the context of an existing minimally invasive thoracic surgery program while maintaining good clinical outcomes when compared with traditional VATS. Process-of-care changes associated with RALS may account for decreased costs in this setting.

Associations of Age at Menopause With Postmenopausal Bone Mineral Density and Fracture Risk in Women.

CONTEXT: Menopause before age 45 is a risk factor for fractures, but menopause occurs at age ≥45 in ~90% of women. OBJECTIVE: To determine, in women with menopause at age ≥45, whether (1) years since the final menstrual period (FMP) is more strongly associated with postmenopausal bone mineral density (BMD) than chronological age and (2) lower age at FMP is related to more fractures. DESIGN AND SETTING: The Study of Women's Health Across the Nation, a longitudinal cohort study of the menopause transition (MT). PARTICIPANTS: A diverse cohort of ambulatory women (pre- or early perimenopausal at baseline, with 15 near-annual follow-up assessments). MAIN OUTCOME MEASURES: Postmenopausal lumbar spine (LS) or femoral neck (FN) BMD (n = 1038) and time to fracture (n = 1554). RESULTS: Adjusted for age, body mass index (BMI), cigarette use, alcohol intake, baseline LS or FN BMD, baseline MT stage, and study site using multivariable linear regression, each additional year after the FMP was associated with 0.006 g/cm2 (P < 0.0001) and 0.004 g/cm2 (P < 0.0001) lower postmenopausal LS and FN BMD, respectively. Age was not related to FN BMD independent of years since FMP. In Cox proportional hazards regression, accounting for race/ethnicity, BMI, cigarette use, alcohol intake, prior fracture, diabetes status, exposure to bone-modifying medications/supplements, and study site, the hazard for incident fracture was 5% greater for each 1-year decrement in age at FMP (P = 0.02). CONCLUSIONS: Years since the FMP is more strongly associated with postmenopausal BMD than chronological age, and earlier menopause is associated with more fractures.

Total Vaginal Hysterectomy With Uterosacral Ligament Suspension Compared With Supracervical Hysterectomy With Sacrocervicopexy for Uterovaginal Prolapse.

OBJECTIVE: To compare prolapse recurrence after total vaginal hysterectomy with uterosacral ligament suspension to recurrence after supracervical hysterectomy with mesh sacrocervicopexy for the primary management of uterovaginal prolapse. METHODS: We conducted a retrospective cohort study of women undergoing uterovaginal prolapse repair at an academic center from 2009 to 2019. Women who underwent vaginal hysterectomy with uterosacral ligament suspension or laparoscopic supracervical hysterectomy with mesh sacrocervicopexy were included. The primary outcome was composite prolapse recurrence (prolapse beyond the hymen or retreatment with pessary or surgery). Secondary outcomes included mesh complications, time to recurrence, and overall reoperation for either prolapse recurrence or mesh complication. We used propensity scoring with a 2:1 ratio of sacrocervicopexy to uterosacral suspension. RESULTS: The cohort consisted of 654 patients, of whom 228 (34.9%) underwent uterosacral suspension and 426 (65.1%) underwent sacrocervicopexy. The median follow-up was longer for the sacrocervicopexy group (230 vs 126 days, P<.001) and less than 1 year for both groups. The uterosacral group had a greater proportion of composite prolapse recurrence (14.9% [34/228] vs 8.7% [37/426], P=.02) and retreatment for recurrent prolapse (7.5% [17/228] vs 2.8% [12/426], P=.02). The uterosacral group demonstrated a shorter time to prolapse recurrence on multivariable Cox regression (hazard ratio 3.14, 95% CI 1.90-5.16). There were 14 (3.3%) mesh complications in the sacrocervicopexy group. Overall reoperation was similar between groups (4.8% [11/228] vs 3.8% [16/426], P=.51). CONCLUSION: Total vaginal hysterectomy with uterosacral ligament suspension was associated with higher rate of, and shorter time-to-prolapse recurrence compared with supracervical hysterectomy with mesh sacrocervicopexy.

Effect of a Primary Care-Based Diabetes Education Model on Provider Referrals and Patient Participation.

PURPOSE: The purpose of this study was to evaluate the impact of a primary care (PC)-based delivery model on diabetes self-management education and support (DSMES) referrals and participation. Despite evidence that DSMES is a critical component of diabetes care, referrals and participation remain low. METHODS: PC practices were assigned to the intervention (n = 6) or usual care (n = 6). Intervention practices had direct access to a diabetes educator (DE) and applied patient-centered medical home elements to DSMES delivery. Usual care practices referred patients to traditional hospital-based outpatient DSMES programs. DSMES referrals and participation were examined for patients with diabetes, 18 to 75 years old, presenting to PC over 18 months (n = 4,894) and compared between groups. RESULTS: Compared to the usual care group, a higher percentage of patients in the intervention practices were referred to DSMES (18.4% vs 13.4%; P < .0001), and of those referred, a higher percentage of patients in the intervention practices participated in DSMES (34.9% vs 26.1%; P = .02). Patient-level factors predicting referrals were obesity (odds ratio [OR] = 1.6), higher A1C (OR = 1.4), female (OR = 1.3), and younger age (OR = 0.98). The only patient-level factor that predicted DSMES participation was lower A1C (OR = 0.9). CONCLUSIONS: This study demonstrates the positive influence of a PC-based intervention on DSMES referral and participation. However, modest improvements in DSMES rates, even with targeted efforts to address reported barriers, raise questions as to what is truly needed to drive meaningful change.

Associations between longitudinal trajectories of insomnia symptoms and sleep duration with objective physical function in postmenopausal women: the Study of Women's Health Across the Nation.

STUDY OBJECTIVES: Examine the association between trajectories of self-reported insomnia symptoms and sleep duration over 13 years with objective physical function. METHODS: We utilized data from 1,627 Study of Women's Health Across the Nation participants, aged 61.9 ± 2.7 years at the end of the 13-year follow-up. Latent class growth models identified trajectories of insomnia symptoms (trouble falling asleep, frequent night-time awakenings, and/or early morning awakening) and sleep duration over 13 years. Physical function tests were performed at the end of the 13-year period: 40-ft walk, 4-m walk, repeated chair stand, grip strength, and balance. Multivariable regression analyses examined each physical function measure according to the insomnia symptom or sleep duration trajectory group. RESULTS: Five insomnia symptom trajectories and two sleep duration trajectories were identified. Women with a consistently high likelihood of insomnia symptoms and women with a decreased likelihood of insomnia symptoms (i.e. improving) had slower gait speed (3.5% slower 40-ft walk [consistently high], 3.7% slower 4-m walk [improving]; each p ≤ .05) than those with a consistently low likelihood of insomnia symptoms. In contrast, women with a steep increase in the likelihood of insomnia symptoms over time and women with persistent insufficient sleep duration had lower odds of having a balance problem (odds ratio [OR] = 0.36 and OR = 0.61, respectively; each p < .02) compared to those with a consistently low likelihood of insomnia symptoms and those with persistent sufficient sleep duration, respectively. CONCLUSION: These results suggest that women's sleep during midlife has important implications for maintaining physical function during the transition into older adulthood.

Assessing the Performance of the De Novo Postoperative Stress Urinary Incontinence Calculator.

OBJECTIVE: The aim of the study was to determine the performance of a previously published stress urinary incontinence (SUI) risk calculator in women undergoing minimally invasive or transvaginal apical suspensions. METHODS: Using a database of stress-continent women who underwent minimally invasive or transvaginal apical suspensions, we calculated 2 prediction risks for development of SUI within 12 months based on inclusion of a "prophylactic" midurethral sling at the time of prolapse surgery. Observed subjective and objective continence status was abstracted from medical records. Regression models were created for the outcome of de novo SUI to generate receiver operating curves. Concordance (c) indices were estimated for the overall and procedure subgroups to determine the calculator's ability to discriminate between SUI outcomes. RESULTS: Analyses included 502 women. De novo SUI was observed in 23.5% of women. The mean ± SD calculated risk of de novo SUI if a sling was performed was 18.9% ± 13.9 at 12 months compared with 36.4% ± 8.3 without sling. The calculator's discriminative ability for those with a planned sling was moderate (c-index = 0.55, P = 0.037). The calculator failed to discriminate continence outcomes when a sling was not planned in the overall group (c-index = 0.50, P = 0.799) and individual apical procedures. CONCLUSIONS: The SUI risk calculator is significantly limited in its ability to predict de novo SUI in our population of women planning minimally invasive apical suspensions. Refinements to the calculator model are needed to improve its utility in clinical practice.

30-Day unanticipated healthcare encounters after prolapse surgery: impact of same day discharge.

BACKGROUND: Same-day discharge is becoming increasingly common in gynecologic surgery; however, data are limited for frequency, setting, and severity of unanticipated healthcare visits for women who are discharged on the day of surgery after major prolapse repair. OBJECTIVE: The purpose of this study was to evaluate whether discharge on the day of surgery is associated with increased 30-day unanticipated healthcare encounters after major pelvic organ prolapse surgery compared with discharge on or after postoperative day 1. STUDY DESIGN: This is a retrospective analysis of women who underwent pelvic organ prolapse surgery by 8 female pelvic medicine and reconstructive surgery surgeons from January 2016 to October 2017. Unanticipated healthcare encounter was a composite variable of any visit to the office, emergency department, or hospital readmission. Number of visits, visit diagnoses, and complication severity (Clavien-Dindo classification) were compared by day of discharge with the use of χ2 tests. Multivariable analyses were performed. RESULTS: Of 405 women, 258 (63.7%) were discharged on the day of surgery, and 147 (36.3%) were discharged on postoperative day 1 or later. Mean age was 66±11 years, body mass index was 27.9±4.8 kg/m2. Most had stage III prolapse (n=273; 67.4%). Procedures included laparoscopic or robotic sacrocolpopexy, (n=163; 40.2%), vaginal apical suspensions (n=115; 28.4%), obliterative (n=105; 25.9%), and concomitant hysterectomy (n=229; 56.5%). There was no increase in the number of women with at least 1 unanticipated healthcare encounter within 30 days of surgery, based on discharge on the day of surgery compared with postoperative day 1 (24.0% vs 26.5%; P=.572). The majority of visits occurred in the office (17.8% vs 19.0%; P=.760). There was no increase in 30-day readmissions (3.5% vs 4.8%; P=.527). The most common visit diagnosis was pain and accounted for 31.5% of all visits, followed by urologic and gastrointestinal symptoms. Diagnoses and complication severity did not vary by day of discharge, except that women who were discharged on the day of surgery were more likely to have a superficial wound separation (11.3% vs 0%; P=.011) and less likely to experience grade II complications (7.4% vs 15.6%, P=.009). Few women had >1 unscheduled visit, and rates were similar between the 2 groups (6.2% vs 6.8%; P=.810). On multivariable regression, younger women (adjusted odds ratio, 1.03; 95% confidence interval, 1.001-1.05), those with lower body mass index (adjusted odds ratio, 1.07; 95% confidence interval, 1.13-1.01), and higher initial postanesthesia recovery unit pain scores (adjusted odds ratio, 1.11; 95% confidence interval, 1.02-1.21) were more likely to have an unanticipated healthcare encounter. Pain complaints were evaluated most often in the office compared with the emergency department (41.1% vs 13.0%); medical complications such as cardiac (15.6% vs 0%) and respiratory (6.5% vs 0%) were more likely to be evaluated in the emergency department. Higher grade complications (II/III) were more likely to visit the emergence department (78.2% vs 27.1%; P<.0001). CONCLUSION: Same-day discharge after prolapse surgery did not result in an increase in 30-day unanticipated healthcare encounters.

Implementation of a urogynecology-specific enhanced recovery after surgery (ERAS) pathway.

OBJECTIVE: Enhanced recovery after surgery protocols were developed for colorectal surgery to hasten postoperative recovery. Variations of the protocol are being adopted for gynecological procedures despite limited population and procedure-specific outcome data. Our objective was to evaluate whether implementation of an enhanced recovery after surgery pathway would facilitate reduced length of admission in a urogynecology population. MATERIALS AND METHODS: In this retrospective analysis of patients undergoing pelvic floor reconstructive surgery by 7 female pelvic medicine and reconstructive surgeons, we compared same-day discharge, length of admission and postoperative complications before and after implementation of an enhanced recovery after surgery pathway at a tertiary care hospital. Groups were compared using χ2 and Student t tests. Candidate variables that could have an impact on patient outcomes with P < .2 were included in multivariable logistic regression models. Satisfaction with surgical experience was assessed using a phone-administered questionnaire the day after discharge. RESULTS: Mean age and body mass index of 258 women (137 before enhanced recovery after surgery and 121 enhanced recovery after surgery) were 65.5 ± 11.3 years and 28.2 ± 5.0 kg/m2. The most common diagnosis was pelvic organ prolapse (n = 242, 93.8%) including stage III pelvic organ prolapse (n = 61, 65.1%). Apical suspension procedures included 58 transvaginal (25.1%), 112 laparoscopic/robotic (48.8%), and 61 obliterative (26.4%). Hysterectomy was performed in 57.4% of women. Demographic and surgical procedures were similar in both groups. Compared with before enhanced recovery after surgery, the enhanced recovery after surgery group had a higher proportion of same-day discharge (25.9% vs 91.7%, P < .001) and a 13.8 hour shorter duration of stay (25.9 ± 13.5 vs 12.1 ± 11.2 hours, P <.001). Operative and postsurgical recovery room times were similar (2.6 ± 0.8 vs 2.6 ± 0.9 hours, P =.955; 3.7 ± 2.1 vs 3.6 ± 2.2 hours, P = .879). Women in the enhanced recovery after surgery group were more likely to be discharged using a urethral catheter (57.9% enhanced recovery after surgery vs 25.4% before enhanced recovery after surgery, P = .005). There were no group differences in total 30 day postoperative complications overall and for the following categories: urinary tract infections, emergency room visits, unanticipated office visits, and return to the operating room. However, enhanced recovery after surgery patients had higher 30 day hospital readmission rates (n = 8, 6.7% vs n = 2, 1.5%, P = .048). Patients before enhanced recovery after surgery were readmitted for myocardial infarction and chest pain. Enhanced recovery after surgery patients were admitted for weakness, chest pain, hyponatremia, wound complications, nausea/ileus, and ureteral obstruction. Three enhanced recovery after surgery patients returned to the operating room for ureteral obstruction (n = 1), incisional hernia (n = 1), and vaginal cuff bleeding (n = 1). Enhanced recovery after surgery patients also had more postoperative nursing phone notes (2.6 ± 1.7 vs 2.1 ± 1.4, P = .030). On multivariable logistic regressions adjusting for age and operative time, same-day discharge was more likely in the enhanced recovery after surgery group (odds ratio, 32.73, 95% confidence interval [15.23-70.12]), while the odds of postoperative complications and emergency room visits were no different. After adjusting for age, operative time, and type of prolapse surgery, readmission was more likely in the enhanced recovery after surgery group (odds ratio, 32.5, 95% confidence interval [1.1-28.1]). In the enhanced recovery after surgery group, patient satisfaction (n = 77 of 121) was reported as very good or excellent by 86.7% for pain control, 89.6% for surgery preparedness, and 93.5% for overall surgical experience; 89.6% did not recall any postoperative nausea during recovery. CONCLUSION: Enhanced recovery after surgery implementation in a urogynecology population resulted in a greater proportion of same-day discharge and high patient satisfaction but with slightly increased hospital readmissions within 30 days.

Triglyceride Levels and Fracture Risk in Midlife Women: Study of Women's Health Across the Nation (SWAN).

CONTEXT: Unfavorable lipid levels contribute to cardiovascular disease and may also harm bone health. OBJECTIVE: Our objective was to investigate relationships between fasting plasma lipid levels and incident fracture in midlife women undergoing the menopausal transition. DESIGN AND SETTING: This was a 13-year prospective, longitudinal study of multiethnic women in five US communities, with near-annual assessments. PARTICIPANTS: At baseline, 2062 premenopausal or early perimenopausal women who had no history of fracture were included. EXPOSURES: Fasting plasma total cholesterol, triglycerides (TG), low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol at baseline and follow-up visits 1 and 3-7. MAIN OUTCOME MEASURE(S): Incident nontraumatic fractures 1) 2 or more years after baseline, in relation to a single baseline level of lipids; and 2) 2-5 years later, in relation to time-varying lipid levels. Cox proportional hazards modelings estimated hazard ratios and 95% confidence interval (CI). RESULTS: Among the lipids, TG levels changed the most, with median levels increased by 16% during follow-up. An increase of 50 mg/dl in baseline TG level was associated with a 1.1-fold increased hazards of fracture (adjusted hazard ratio, 1.11; 95% CI, 1.04-1.18). Women with baseline TG higher than 300 mg/dl had an adjusted 2.5-fold greater hazards for fractures (95% CI, 1.13-5.44) than women with baseline TG lower than 150 mg/dl. Time-varying analyses showed a comparable TG level-fracture risk relationship. Associations between total cholesterol, low-density lipoprotein cholesterol, or high-density lipoprotein cholesterol levels and fractures were not observed. CONCLUSIONS: Midlife women with high fasting plasma TG had an increased risk of incident nontraumatic fracture. Secondary Abstract: Midlife women with fasting plasma triglyceride (TG) of at least 300 mg/dl had 2.5-fold greater hazards of fracture in 2 years later and onward, compared to those with TG below 150 mg/dl, in a multiethnic cohort. Time-varying analyses revealed comparable results.

Who can provide diabetes self-management support in primary care? Findings from a randomized controlled trial.

PURPOSE: The purpose of this comparative effectiveness study is to compare diabetes self-management support (DSMS) approaches and determine who can be most effective in helping patients maintain/improve clinical outcomes, self-care behaviors, distress, and satisfaction following diabetes self-management education (DSME) delivered in primary care. METHODS: After receiving DSME, 141 participants were randomized to receive DSMS delivered by a trained supporter: educator, peer, practice staff, or usual education during a 6-month follow-up period. DSMS groups were compared to determine which supporter helped participants to maintain/improve A1C, blood pressure, lipids, weight, self-care, and distress. DSMS satisfaction was also examined. RESULTS: There was a significant improvement in A1C, empowerment, aspects of self-care, and distress following DSME at 6 weeks. Those in the educator DSMS group best sustained improved A1C while those in the other DSMS groups maintained glycemic improvements but began to show trends toward worsening. No significant differences or clear trends were seen in other clinical, behavioral, or psychosocial outcomes. The Program Reinforcement Impacts Self-Management (PRISM) study demonstrates that following DSME, participants maintained improved glycemia, lipid, weight, and self-care behaviors and reductions in distress throughout the delivery of DSMS interventions regardless of DSMS supporter. All of the participants reported satisfaction with DSMS. CONCLUSIONS: These findings reaffirm the critical role of educators but suggest that others may serve as DSMS supporters. Results suggest that DSME delivered in primary care is effective and multiple DSMS agents are reasonable. As patient-centered self-management approaches are being explored in primary care, delivery of DSME and DSMS becomes paramount.