Objective: We conducted an analysis of the American College of Surgeons National Surgical Quality Improvement Program database for minimally -invasive partial nephrectomy cases reported with the goal to identify pre- and peri-operative variables associated with length of stay (LOS) greater than 3 days and readmission within 30 days. Methods: Records from 2008 to 2018 for "laparoscopy, surgical; partial nephrectomy" for prolonged LOS and readmission cohorts were compiled. Univariate analysis with Chi-square, t -tests, and multivariable logistic regression analysis with odds ratios (ORs), p -values, and 95% confidence intervals assessed statistical associations. Results: Totally, 20 306 records for LOS greater than 3 days and 15 854 for readmission within 30 days were available. Univariate and multivariable analysis exhibited similar results. For LOS greater than 3 days, undergoing non -elective surgery (OR=5.247), transfusion of greater than four units within 72 h prior to surgery (OR=5.072), pre -operative renal failure or dialysis (OR=2.941), and poor pre -operative functional status (OR=2.540) exhibited the strongest statistically significant associations. For hospital readmission within 30 days, loss in body weight greater than 10% in 6 months prior to surgery (OR=2.227) and bleeding disorders (OR=2.081) exhibited strongest statistically significant associations. Conclusion: Multiple pre- and peri-operative risk factors are independently associated with prolonged LOS and hospital readmission within 30 days of surgery using the American College of Surgeons National Surgical Quality Improvement Program data. Recognizing the risks factors that can potentially be improved prior to minimally -invasive partial nephrectomy is crucial to informing patient selection, optimization strategies, and patient education. 2024 Editorial Office of Asian Journal of Urology. Production and hosting by Elsevier B.V. This is an open access article under the CC BY -NC -ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
Background: Optimization of surgical scheduling represents an opportunity to improve resource utilization and increase patient access. Increasing body mass index (BMI) has been associated with increased operating time and may provide an opportunity to more accurately predict operating time. Objective: To investigate the relationship between BMI and operative time for benign hysterectomy and develop a predictive model for hysterectomy operating time based on patient BMI. Methods: A secondary analysis of women undergoing benign laparoscopic, abdominal, or vaginal hysterectomy between 2014 and 2019 was performed using the American College of Surgeons National Surgical Quality Improvement Program database, N 5 117,691. Our primary outcome was log10 transformation of operative time. Multivariable linear regression was used to analyze the relationship between operative time and BMI. A model to predict operating time was created using variables that could be reliably obtained preoperatively. Results: From our cohort, 22% of benign hysterectomies were performed abdominally, 16% were vaginal, and 62% were laparoscopic, and mean operative times were 144, 133, and 158 minutes, respectively. For every 10-unit increase in BMI, estimated mean operation time (OT) increased by 12.8%, 8.1%, and 6.5% for abdominal, vaginal, and laparoscopic hysterectomy, respectively. Neither an expanded nor a concise model was able to account for the variability in log10(OT). Conclusion: Increasing BMI differentially impacts the operative time in abdominal greater than laparoscopic and vaginal hysterectomy. However, operative time for hysterectomy is highly variable, and its estimation is difficult to reliably predict using common preoperative variables.
OBJECTIVE:Management of lower extremity (LE) wounds has evolved with the establishment of specialized limb preservation services. Although clinical factors contribute to limb outcomes, socioeconomic status and community factors also influence the risk for limb loss. The Distressed Community Index (DCI) score is a validated index of social deprivation created to provide an objective measure of economic well-being in United States communities. Few studies have examined the influence of geographic deprivation on outcomes in patients with LE wounds. We examined relationships between socioeconomic deprivation and outcomes of inpatients evaluated by a dedicated limb preservation service (Functional Limb Extremity Service [FLEX]). METHODS:Inpatients referred to FLEX over a 5-year period were included. Wound, Ischemia, foot Infection (WIfI) staging was collected. DCI scores were determined using seven indices based on ZIP Code. Outcomes included any minor or major amputations, any endovascular or open LE revascularization, or wound care procedures. Disease etiology, demographic, and anthropometric data were collected. Associations between neighborhood deprivation and limb-specific outcomes were evaluated in models for the DCI and each of its components separately. RESULTS:A total of 677 patients were included. Thirty-eight percent were female, with a mean age of 64 years. Sixty percent had WIfI stage 3 or 4 risk of amputation, and 43% had WIfI stage 3 or 4 risk of revascularization. Mean ankle-brachial index and toe pressure were 0.96 (standard deviation [SD], 0.43) and 80 (SD, 57) mmHg. Thirty-five percent were non-White. Amputation was performed in 31% of patients, whereas 17% underwent revascularization. The mean distress score was 64 (SD, 24). Mean DCI scores did not differ across WIfI scores. Likewise, overall DCI distress score was not related to any of the outcomes in univariable or multivariable linear regression models. In univariable linear regression models for amputation, higher poverty rate (odds ratio for SD increase 1.20; 95% confidence interval, 1.02-1.42; P = .025) was significantly associated with the outcome. In multivariable models, neither DCI distress score nor any of its components remained significantly associated with the outcome. CONCLUSIONS:Despite known racial disparities in limb-specific outcomes, an aggregate measure of community level distress was not found to be related to outcomes. Although the poverty rate demonstrated a significant relationship with amputation in univariable analysis, this association was not found in multivariable models. Notably, non-White race emerged as a predictor of amputation, underscoring the importance of addressing racial disparities in LE outcomes. Further investigation of potential determinants of LE outcomes is needed, particularly the interaction of such factors with race.
Objective: The superior transseptal approach to mitral valve surgery offers improved exposure compared with left atriotomy; however, concerns remain regarding postoperative arrhythmias and pacemaker placement. This study investigates intraoperative parameters and postoperative outcomes in these approaches. Methods: Retrospective review of 259 adults undergoing isolated mitral valve repair or replacement over a 10-year period was performed. Exclusion criteria included previous history of permanent pacemaker placement and concomitant cardiac procedures. The primary outcome evaluated was postoperative permanent pacemaker placement. Secondary outcomes included postoperative new-onset atrial fibrillation, new-onset arrhythmias, major adverse cardiovascular events, length of stay, and mortality. Results: Of 259 surgeries, 116 were performed via left atriotomy and 143 via superior transseptal approach. The overall incidence of postoperative permanent pacemaker placement was 3.0%, with similar rates (left atriotomy 1.7% vs superior transseptal 4.2%, P = .30). The incidence of new-onset atrial fibrillation (31.0% vs 42.7%, P = .055) and arrhythmias in general (37.1% vs 49.0%, P = .06) was similar. Rates of other secondary outcomes, such as major adverse cardiovascular events and mortality, were similar between cohorts. In addition, cardiopulmonary bypass and aortic crossclamp times did not differ. Interestingly, intensive care unit (55 vs 73 hours, P = .04) and postoperative length of stay (6.8 vs 9.0 days, P = .002) were shorter after left atriotomy. Conclusions: The superior transseptal approach provides optimal exposure while preserving similarly low rates of postoperative morbidity and mortality to left atriotomy. There is no difference in the incidence of postoperative permanent pacemaker placement and new-onset arrhythmias.
Background: In 2012 the United States Preventative Services Task Force (USPSTF) changed its prostate-specific antigen (PSA) screening recommendation to a category "D". The purpose of this study is to examine racial, ethnic, and socioeconomic differences in risk of presentation with metastatic prostate cancer (mPCa) at time of diagnosis before and after the 2012 USPSTF category "D" recommendation. Methods: This is a population-based cohort study. We identified patients with mPCa at diagnosis within the National Cancer Database from 2004-2017. Logistic regression models were used to examine associations of mPCa with age, race, ethnicity, geographic location, education level, income, and insurance status. Linear regression models assuming underlying binomial distribution were fitted to annual percentage of mPCa at diagnosis for years 2012-2017 to evaluate the post category "D" recommendation era. Results: From 2004 to 2017, 88,987 patients presented with mPCa. A higher percentage of mPCa was noted post-USPSTF category "D" recommendation, with a disproportionately greater increase observed among Hispanics and non-Hispanic Blacks [Delta slope/year: Hispanics (0.0092), non-Hispanic Blacks (0.0073) and non-Hispanic Whites (0.0070)]. Insurance status impacts race/ethnicity differently: uninsured Hispanics were 3.66 times more likely to present with mPCa than insured Hispanics, while uninsured non-Hispanic Blacks were 2.62 times more likely to present with mPCa than insured non-Hispanic Blacks. Household income appears to be associated with differences in mPCa, particularly among non-Hispanic Blacks. Those earning <$30,000 were more likely to present with mPCa compared to higher income brackets. Conclusions: Since the USPSTF grade "D" recommendation against PSA screening, the percentage of mPCa at diagnosis has increased, with a higher rate of increase among Hispanic and non-Hispanic Blacks compared to non-Hispanic Whites.
BACKGROUND:Frailty is associated with adverse surgical outcomes including post-operative complications, needs for post-acute care, and mortality. While multiple frailty screening tools exist, most are time and resource intensive. Here we examine the association of an automated electronic frailty index (eFI), derived from routine data in the Electronic Health Record (EHR), with outcomes in vascular surgery patients undergoing open, lower extremity revascularization. METHODS:A retrospective analysis at a single academic medical center from 2015 to 2019 was completed. Information extracted from the EHR included demographics, eFI, comorbidity, and procedure type. Frailty status was defined as fit (eFI≤0.10), pre-frail (0.100.21). Outcomes included length of stay (LOS), 30-day readmission, and non-home discharge. RESULTS:We included 295 patients (mean age 65.9 years; 31% female), with the majority classified as pre-frail (57%) or frail (32%). Frail patients exhibited a higher degree of comorbidity and were more likely to be classified as American Society of Anesthesiologist class IV (frail: 46%, pre-frail: 27%, and fit: 18%, P = 0.0012). There were no statistically significant differences in procedure type, LOS, or 30-day readmissions based on eFI. Frail patients were more likely to expire in the hospital or be discharged to an acute care facility (31%) compared to pre-frail (14%) and fit patients (15%, P = 0.002). Adjusting for comorbidity, risk of non-home discharge was higher comparing frail to pre-frail patients (OR 3.01, 95% CI 1.40-6.48). DISCUSSION:Frail patients, based on eFI, undergoing elective, open, lower extremity revascularization were twice as likely to not be discharged home.
Background: The purpose of this study was to provide an updated description of demographics, technical details, and clinical outcomes of 101 consecutive branch renal artery repairs in 98 patients using cold perfusion. Methods: A single-institution, retrospective analysis branch renal artery reconstructions was performed between 1987 and 2019. Results: Patients were predominantly Caucasian (80.6%) women (74.5%) with a mean age of 46.8 6 15.3 years. The mean preoperative systolic and diastolic blood pressures were 170.4 +/- 33.0 mm Hg and 99.2 +/- 19.9 mm Hg, respectively, requiring a mean of 1.6 +/- 1.1 antihypertensive medications. The estimated glomerular filtration rate was 84.0 +/- 25.3 mL/min. Most patients (90.2%) were not diabetic and never smokers (68%). Treated pathology included aneurysm (87.4%) and stenosis (23.3%) with histology demonstrating fibromuscular dysplasia (44.4%), dissection (5.1%), and degenerative not otherwise specified (50.5%). The right renal arteries were most frequently treated (44.2%), with amean of 3.1 6 1.5 branches involved. Reconstruction was accomplished using bypass in 90.3% of cases using aortic inflowin 92.7% and a saphenous vein conduit in 92%. Branch vessels served as outflow in 96.9% and syndactylization of branches was used to decrease the number of distal anastomoses in 45.3% of repairs. The mean number of distal anastomoses was 1.5 +/- 0.9. Postoperatively, the mean systolic blood pressure improved to 137.9 +/- 20.8mmHg (mean decrease of 30.5 +/- 32.8 mm Hg; P < .0001) and the mean diastolic blood pressure improved to 78.4 +/- 12.7 mm Hg (mean decrease of 20.1 +/- 20.7 mm Hg; P < .0001) with patients requiring a mean of 1.4 +/- 1.0 antihypertensive medications (mean decrease of 0.2 +/- 1.0 medications; P = .048). The postoperative estimated glomerular filtration rate was 89.1 mL/min (mean increase of 4.1 mL/min; P = .08). The mean length of stay was 9.0 +/- 5.8 days and 96.1% of patients were discharged home. The mortality rate was 1% (one patient with liver failure) and the major morbidity rate was 15%. There were five infectious complications (pneumonia, Clostridium difficile, and wound infection) and five patients required return to the operating room (one for nephrectomy, one for bleeding, two for thrombosis, and one for second trimester pregnancy loss requiring dilation and curettage and splenectomy). One patient required temporary dialysis owing to graft thrombosis. Two patients developed arrhythmias. No patients suffered a myocardial infarction, stroke, or limb loss. After 30 days, follow-up data were available for 82 bypasses. At this time, three reconstructions were no longer patent. Intervention was required to retain patency for five bypasses. After 1 year, patency data were available for 61 bypasses and five were no longer patent. Of the five grafts with loss of patency, two underwent intervention in attempt to maintain patency, which subsequently failed. Conclusions: Repair of renal artery pathology involving the branches can be performed with short- and long-term technical success and significant prospect of decreasing an elevated blood pressure. The operations required to fully address the presenting pathology are often quite complex involving multiple distal anastomoses and consolidation of small secondary branches. The procedure carries a small but significant risk of major morbidity and mortality.
BACKGROUND:Peripheral neuropathy is associated with amputation risk among patients with diabetes mellitus and chronic limb-threatening ischemia (CLTI). Detection of peripheral neuropathy may help identify those who are at an increased risk, but the predictive ability of the screening tool used in patients with peripheral arterial disease (PAD) needs to be more clearly defined. METHODS:Patients referred to vascular surgery clinic for PAD were recruited from a single center. Exclusion criteria were a documented history of neuropathy or prior lower limb amputation. Screening utilized the Michigan Neuropathy Screening Instrument (MNSI). Scores >2.5 were considered abnormal and scores >4 were considered positive for peripheral neuropathy. Limb-specific outcomes of amputation and revascularization as well as a composite outcome including death were modeled using time to event analysis. RESULTS:86 patients were recruited. Mean age was 67 ± 10.2 years, 30% were women, 24% were black. Mean ankle-brachial index was 0.74 ± 0.3. PAD symptoms at initial evaluation were claudication in 52% of patients and CLTI in 38% of patients. Neuropathy was present in 20% of the cohort with a significantly higher proportion in diabetics (34% vs. 3%; P = 0.0009). Neuropathy was more common in patients with CLTI compared to claudicants (36% vs. 9%; P = 0.011). Forty patients (47%) reached the composite outcome of amputation, revascularization, or death with a median time to event of 16 months. Abnormal MNSI examination was significantly associated with the increased risk of the composite outcome (hazard ratio = 3.19; P 0.0005). CONCLUSIONS:A significant proportion of patients presenting to vascular specialists for PAD have undiagnosed neuropathy. Patients with PAD and neuropathy have an increased risk of amputation, revascularization, and death. Expanding neuropathy screening in vascular surgery clinic visits may help to identify patients at higher risk.
PURPOSE:To evaluate the recently reported relative diagnostic accuracy of US, CT, MRI, and cholescintigraphy for diagnosing acute cholecystitis.METHODS:2 radiologists independently performed systematic electronic searches for articles published between 2000 and 2021 and applied inclusion/exclusion criteria. 2 different radiologists extracted data from the articles and scored each with a methodological quality tool. Pooled estimates of sensitivity and specificity were calculated with a bivariate linear mixed model. A second analysis made head-to-head comparisons (US vs. CT, US vs. cholescintigraphy). Factors were also analyzed for potential confounding effects on diagnostic accuracy.RESULTS:Of 6121 initial titles, 22 were included. The prevalence of cholecystitis varied widely across studies (9.4-98%). Pooled sensitivity and specificity estimates were 69% (confidence limit [CL] 62-76%) and 79% (CL 71-86%) for US, 91% (CL 86-94%) and 63% (CL 51-74%) for cholescintigraphy, 78% (CL 69-84%) and 81% (CL 71-88%) for CT, and 91% (CL 78-97%) and 93% (CL 70-99%) for MRI. Regarding head-to-head comparisons, the sensitivity of CT (87.6%, CL 70-96%) was significantly higher than US (66.8%, CL 43-84%), while specificities (81.7% with CL 54-95% for US, 91.9% with CL 67-99% for CT) were similar. The sensitivity of cholescintigraphy (87.4%, CL 76-94%) was significantly greater than US (61.6%, CL 44-77%), while the specificity of US (82%, CL 65-92%) was significantly higher than cholescintigraphy (68%, CL 47-84%).CONCLUSION:Recent data suggests that CT may have a higher sensitivity than US for diagnosing acute cholecystitis, with similar specificity. Cholescintigraphy remains a highly sensitive modality with lower specificity than previously reported. MRI remains under studied, but with promising results.
Stutsrim, Ashlee MD; Callahan, Kathryn MD; Pajewski, Nicholas PhD; Craven, Tim MSPH; Corriere, Matthew MD, FACS; Davis, Ross MD, FACS; Edwards, Matthew MD, FACS; Goldman, Matthew MD, FACS Author Information
Background Little is known about the effects of secondhand marijuana smoke on children. We aimed to determine caregiver marijuana use prevalence and evaluate any association between secondhand marijuana smoke, childhood emergency department (ED) or urgent care (UC) visitation, and several tobacco-related illnesses: otitis media, viral respiratory infections (VRIs), and asthma exacerbations. Methods This study was a cross-sectional, convenience sample survey of 1500 subjects presenting to a pediatric ED. The inclusion criteria were as follows: caregivers aged 21–85 years, English- or Spanish-speaking. The exclusion criteria were as follows: children who were critically ill, medically complex, over 11 years old, or using medical marijuana. Results Of 1500 caregivers, 158 (10.5%) reported smoking marijuana and 294 (19.6%) reported smoking tobacco. Using negative-binomial regression, we estimated rates of reported ED/UC visits and specific illnesses among children with marijuana exposure and those with tobacco exposure, compared to unexposed children. Caregivers who used marijuana reported an increased rate of VRIs in their children (1.31 episodes/year) compared to caregivers with no marijuana use (1.04 episodes/year) ( p = 0.02). Conclusions Our cohort did not report any difference with ED/UC visits, otitis media episodes, or asthma exacerbations, regardless of smoke exposure. However, caregivers of children with secondhand marijuana smoke exposure reported increased VRIs compared to children with no smoke exposure. Impact Approximately 10% of caregivers in our study were regular users of marijuana. Prior studies have shown that secondhand tobacco smoke exposure is associated with negative health outcomes in children, including increased ED utilization and respiratory illnesses. Prior studies have shown primary marijuana use is linked to negative health outcomes in adults and adolescents, including increased ED utilization and respiratory illnesses. Our study reveals an association between secondhand marijuana smoke exposure and increased VRIs in children. Our study did not find an association between secondhand marijuana smoke exposure and increased ED or UC visitation in children.
Objective: To estimate the health utility impact of diabetes-related complications in a large, longitudinal U.S. sample of people with type 2 diabetes. Research Design and Methods: We combined Health Utility Index-3 data on patients with type 2 diabetes from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) and Action for Health in Diabetes (Look AHEAD) trials and their follow-on studies. Complications were classified as events if they occurred in the year preceding the utility measurement; otherwise, they were classified as a history of the complication. We estimated utility decrements associated with complications using a fixed-effects regression model. Results: Our sample included 15,252 persons with an average follow-up of 8.2 years and a total of 128,873 person-visit observations. The largest, statistically significant (p < 0.05) health utility decrements were for stroke (event: −0.109; history: −0.051), amputation (event: −0.092; history: −0.150), congestive heart failure (CHF; event: −0.051; history: −0.041), dialysis (event: −0.039), estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (event: −0.043; history: −0.025), angina (history: −0.028), and myocardial infarction (MI) (event: −0.028). There were smaller effects for laser photocoagulation, and eGFR < 60 mL/min/1.73 m2. Decrements for dialysis history, angina event, MI history, revascularization event, revascularization history, laser photocoagulation event, and hypoglycemia were not significant (p >= 0.05) Conclusions: Using a large study sample and a longitudinal design, our estimated health utility scores are expected to be largely unbiased. Estimates can be used to describe the health utility impact of diabetes complications, improve cost-effectiveness models, and inform diabetes policies.
The purposes of this study are (1) to utilize multivariable logistic regression in order to evaluate which image feature combination is most predictive in the diagnosis of cholecystitis for computed tomography (CT) and ultrasound (US) in adult ED patients and (2) to use these results to compare the accuracy of CT and US. For RUQ pain patients undergoing US and CT at the same visit, multiple image features were evaluated independently by 2 radiologists blinded to additional data. Inter-reader variability was measured with the Kappa statistic. Sonographic Murphy’s sign (SMS) information was obtained from original reports. Multivariable logistic regression was utilized to develop optimal predictive models for each modality. For US, models with/without SMS were compared to establish its relative value. 446 patients met inclusion criteria. For CT, the combination of cholelithiasis, short-axis gallbladder diameter > 3 cm, pericholecystic fluid or inflammation, and mural thickening > 3 mm provided the optimal model for both readers. For US, the optimal model included cholelithiasis, short-axis diameter > 3 cm, mural heterogeneity/striation, and sludge/debris for both readers. Kappa = 0.79–0.96 for included image features. For both readers, CT and US models had equivalent diagnostic performances; the SMS did not contribute significantly to US models. For a diagnosis of cholecystitis in the ED, (1) the optimal image feature combination for CT is cholelithiasis, short-axis diameter > 3 cm, pericholecystic fluid or inflammation, mural thickening > 3 mm; and cholelithiasis, short-axis diameter > 3 cm, mural heterogeneity/striation, sludge/debris for US; (2) CT and US have equivalent diagnostic performance; (3) inter-reader reliability is substantial to excellent for utilized image features; (4) the SMS does not affect US model accuracy.
Purpose: We sought to determine the role of body mass index (BMI) on quality indicators, such as length of stay and readmission. The National Surgical Quality Improvement Program (NSQIP) database was queried to examine the effect of obesity, defined as BMI >30, on outcomes after Minimally Invasive Radical Retropubic Prostatectomy (MI-RRP). Materials and Methods: Utilizing the NSQIP database, patient records were identified using the Current Procedural Terminology (CPT) code 55866 (laparoscopy, surgical prostatectomy, radical retropubic) during a 10-year period (2007-2017). Obesity was classified according to the CDC classification. Chi-square tests were utilized to evaluate BMI distribution by surgery year. Logistic regression was used to evaluate the relationship of BMI with length of stay (LOS) and hospital readmission within 30 days, after controlling for preoperative variables. Results: Records of 49,238 patients who have undergone MI-RRP during 2007-2017 were evaluated. Mean yearly BMI rose from 28.5 to 29.2, while the percentage of surgical patients with BMI >30 rose by 5% (33% to 38%; p< 0.0001) over the study period. Obese patients demonstrated higher morbidity, prolonged LOS, and increased readmission rates after MI-RRP. Obesity severity correlated negatively with quality indicators in a graded fashion. Conclusions: Obesity rates in patients undergoing MI-RRP increased from 2007-2017. Obese patients are at increased risk of morbidity, prolonged LOS, and readmission within 30 days, following MI-RRP. These patients should not be excluded from MI-RRP; rather, physicians should discuss these increased risks with their patients. Proper weight loss strategies should be instituted preoperatively to mitigate these risks.
PURPOSE: To correlate changes in urinary patient-reported outcomes including the International Prostate Symptom Score (IPSS), acute urinary retention and urethral stricture with urethral dose in those treated with low dose rate (LDR) prostate brachytherapy. MATERIALS AND METHODS: Patients treated with prostate LDR between 2012 and 2019 (n = 117) completed IPSS urinary symptom assessments prior to treatment and at each follow-up. CT simulation was obtained with urinary catheter 1-month post-implant for dosimetric analysis. 113 patients with pre- and >= 1 post-LDR IPSS score available were analyzed. Urethral dosimetric parameters including U75, U100, U125, U150 and U200 were abstracted from post-implant dosimetry and assessed for association with urinary toxicity using bivariate logistic regression and Spearman correlation. Outcomes included clinically significant change (CSC, defined as 4 or more points or 25% rise above baseline) in IPSS score at 6 and 12 months, acute urinary retention (AUR), and urethral stricture (US). RESULTS: 89 (79%) patients were treated with LDR monotherapy (145 Gy) and 24 (21%) with LDR boost (110 Gy) with external beam radiation therapy. Twenty (18%) had baseline IPSS >= 15. Median IPSS scores were: baseline 6 (3 -12; n = 113), 1-month 17 (10-25; n = 110), 6 months 12 (7-18; n = 77), 1 year 8 (5 -14; n = 52). CSC-6 was observed in 59 (77%), CSC-12 in 26 (50%), AUR in 12 (11%), and US in 4 (4%). No association was identified between urethral dose parameters and CSC-6, CSC-12, AUR, or US. No correlation between urethral dose and IPSS at 6- and 12-months was identified. The IPSS >= 15 group exhibited lower rates of CSC-12 (13% v. 57%, p = 0.05) but not CSC-6 (55% v. 80%, p = 0.12). CONCLUSIONS: We did not find a relationship between urethral dose and IPSS elevation, AUR or US. We did identify a significantly lower change in IPSS at 12 months for those with baseline IPSS >= 15 compared to those with low baseline scores. (C) 2021 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.
Structured walking exercise programs with activity tracking are an alternative to supervised exercise therapy for claudication, but related outcomes are unknown. We conducted a multicenter, randomized, crossover study comparing usual care (walking advice) vs a digital health intervention integrating Fitbit (San Francisco, Calif) tracking and educational materials. Design and outcomes were publicly registered (clinicaltrials.gov NCT03554564). Randomization determined the order of intervention phases, and each phase lasted 4 weeks. The primary outcome was exercise adherence, assessed using Fitbit tracking during the digital health intervention and self-report using a diary during usual care. Secondary patient-reported outcomes included the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function and Pain Interference Short Forms, the Vascular Quality of Life Questionnaire-6 (VascuQol-6), and the Walking Impairment Questionnaire (WIQ). Differences in mean scores between phases were examined using mixed linear models. There were 28 patients who were recruited and randomized. Mean baseline ankle-brachial index was 0.6 ± 0.2. Exercise adherence was 72% ± 28% during the digital health phase vs 68% ± 32% during the usual care phase (P = .64). No significant differences from baseline or between interventions were identified for PROMIS measures (Table). Significant increases from baseline VascuQol-6 scores were observed after both phases (1.30 ± 0.54 for usual care [P = .02] and 1.56 ± 0.58 for digital health [P = .01]) without a significant difference between interventions (P = .45). Significant decreases from baseline were observed for overall WIQ scores and all subscales after the digital health phase but only for the distance subscale after the usual care phase (Table). Compared with usual care, the digital health intervention was associated with significantly greater increases in the overall WIQ score (P < .01) and the speed and stairs subscales (P = .03 and P < .01, respectively) but not the distance subscale (P = .45). Structured exercise digital health intervention with Fitbit tracking was associated with similar exercise adherence and superior increases in WIQ score compared with usual care. Peripheral artery disease-specific patient-reported outcomes with domains related to speed and stairs may be more sensitive than general or distance-dependent measures for assessing responses to exercise interventions.TablePatient-reported OutcomesWalking Advice with self-Report (Mean±SEM)Digital health with fitbit tracking (Mean±SEM)Between- phase Difference (P)PROMIS Physical Function SF 6b39.1±1.539.0±1.4.83PROMIS Pain Interference SF61.5±1.360.4±1.4.34VascuQuol-613.4±0.9a13.7±0.8a.47Walking Impairment Questionnaire (WIQ)28.7±4.636.9±4.5a<.01Distance Subscale (WIQ)32.8±5.6a37.3±6.9a.45Speed Subscale (WIQ)26.6±4.332.8±4.5a.03Stairs Subscale (WIQ)26.9±5.238.0±5.7a<.01aP < .05 versus baseline score at enrollment. Open table in a new tab
BACKGROUND:Diabetes mellitus is a major risk factor for progression to lower extremity amputation (LEA) due to progressive neuropathy and glycemia-induced vasculopathy. In this study, we evaluated risk factors for incident LEA type 2 diabetics during a randomized controlled trial and extended post-trial follow-up. METHODS:The Action to Control Cardiovascular Risk in Diabetes trial randomized 10,251 type 2 diabetics to intensive glycemic control (Hemoglobin A1c (HbA1c) target <6.0%) versus standard glycemic control (HbA1c target 7.0-7.9%). Using backward elimination logistic regression models, we examined relationships between neuropathy using the Michigan Neuropathy Screening Instrument (MNSI) and glycemic control and incident LEA during the clinical trial and subsequent follow-up. RESULTS:9,746 patients were followed for a mean of 7.9 +/-3.1 (median 8.9) years after randomization. Ninety-eight (1%) participants underwent an incident LEA during the trial or post-trial follow-up period. Baseline demographics and traditional risk factors were examined by incident amputation status. Multivariable models revealed that abnormal 10 gm filament test (HR 4.50, 95% CI 2.92-6.95, P < 0.0001), presence of ulceration (HR 4.22, 95% CI 1.65-10.8, P = 0.0004), abnormal appearance on foot examination (HR 4.75, 95% CI 2.30-9.83, P < 0.0001), and mean postrandomization HbA1c (HR 1.65, 95% CI 1.35-2.00, P < 0.0001) were strongly predictive of LEA when accounting for other common risk factors for amputation. CONCLUSIONS:In this post hoc analysis of a large randomized controlled population of diabetic patients, we found that components of the MNSI score including presence of ulceration, abnormal appearance of the foot, and 10 gm filament monofilament scoring were strongly predictive of LEA. This adds a valuable clinical tool in the risk stratification of diabetic patients for LEA.
INTRODUCTION: Recurrent HCC following surgical resection is a major complication. Reliable predictors of HCC recurrence are lacking. Degree of tumor differentiation, the presence of vascular invasion and satellite lesions are often utilized. Alternatively, the risk of recurrent HCC after liver transplantation can be predicted by use of the RETREAT score, which utilizes tumor burden (largest visible tumor + number of visible tumors), presence of microvascular invasion, and plasma α-fetoprotein (AFP) level. We aimed to determine if the RETREAT score can predict the risk of HCC recurrence when applied to patients who have undergone surgical resection for HCC. METHODS: Surgical databases at our center were queried to identify 58 patients with cirrhosis who had undergone resection for HCC between 2000 and 2016. Resection pathology was reviewed to determine the number/size of tumors, and degree of histologic differentiation. Post-resection imaging was reviewed to determine post-operative tumor-free survival by the Kaplan-Meier method. Multivariable proportional hazards regression was used to identify if components the RETREAT score had predictive value for recurrence at P < 0.05. RESULTS: The average age of the cohort was 61 ± 10 yrs; 69% (40/58) were male. The most common etiology of cirrhosis was HCV (55%; 32/58). NAFLD accounted for 12% (7/58). AFP was > 200 ng/mL in 24% (14/58). The 5-year recurrence rate was 65% (38/58). There were no significant differences between the tumor-free group and the HCC recurrence group in gender or racial distribution, liver disease etiology, degree of tumor differentiation, or RETREAT score (all P-values NS). Largest tumor diameter (HR 1.49, 95% CI 1.03–2.16 per SD increase of 4 cm) (Figure 2) and the presence of micro or macrovascular invasion (HR 2.10, 95% CI 1.02–4.32) were significant predictors of HCC recurrence risk. AFP was not predictive. CONCLUSION: The RETREAT score did not accurately predict the risk of HCC recurrence in patients undergoing surgical resection. However, contrary to previous studies, these data suggest that the largest tumor size is predictive of recurrence. This is likely because tumor size (in conjunction with number) comprise overall tumor burden, a robust predictor of recurrence. These data confirm the role of vascular invasion in predicting post-resection recurrence. These results are congruent with published data from a large multinational registry.Figure 1.: Predicted post-surgical recurrence-free survival for largest tumor diameters of 2.7 cm (25th %-tile) and 8.2 cm (75th %-tile) [P = 0.04].