Projected Incidence of Hepatobiliary Cancers and Trends Based on Age, Race, and Gender in the United States.

BACKGROUND: Identifying the projected incidence of hepatobiliary cancers and recognizing patient cohorts at increased risk can help develop targeted interventions and resource allocation. The expected incidence of subtypes of hepatobiliary cancers in different age groups, races, and genders remains unknown. METHODS: Historical epidemiological data from the Surveillance, Epidemiology, and End Results (SEER) database was used to project future incidence of hepatobiliary malignancies in the United States and identify trends by age, race, and gender. Patients ≥18 years of age diagnosed with a hepatobiliary malignancy between 2001 and 2017 were included. US Census Bureau 2017 National Population projects provided the projected population from 2017 to 2029. Age-Period-Cohort forecasting model was used to estimate future births cohort-specific incidence. All analyses were completed using R Statistical Software. RESULTS: We included 110381 historical patients diagnosed with a hepatobiliary malignancy between 2001 and 2017 with the following subtypes: hepatocellular cancer (HCC) (68%), intrahepatic cholangiocarcinoma (iCCA) (11.5%), gallbladder cancer (GC) (8%), extrahepatic cholangiocarcinoma (eCCA) (7.6%), and ampullary cancer (AC) (4%). Our models predict the incidence of HCC to double (2001 to 2029) from 4.5 to 9.03 per 100,000, with the most significant increase anticipated in patients 70-79 years of age. In contrast, incidence is expected to continue to decline among the Asian population. Incidence of iCCA is projected to increase, especially in the white population, with rates in 2029 double those in 2001 (2.13 vs. 0.88 per 100,000, respectively; p < 0.001). The incidence of GC among the black population is expected to increase. The incidence of eCCA is expected to significantly increase, especially among the Hispanic population, while that of AC will remain stable. DISCUSSION: The overall incidence of hepatobiliary malignancies is expected to increase in the coming years, with certain groups at increased risk. These findings may help with resource allocation when considering screening, treatment, and research in the coming years.

Incidence and Outcomes of New-Onset Right Bundle Branch Block Following Transcatheter Aortic Valve Replacement.

BACKGROUND: The incidence and prognosis of right bundle branch block (RBBB) following transcatheter aortic valve replacement (TAVR) are unknown. Hence, we sought to characterize the incidence of post-TAVR RBBB and determine associated risks of permanent pacemaker (PPM) implantation and mortality. METHODS: All patients 18 years and above without preexisting RBBB or PPM who underwent TAVR at US Mayo Clinic sites and Mayo Clinic Health Systems from June 2010 to May 2021 were evaluated. Post-TAVR RBBB was defined as new-onset RBBB in the postimplantation period. The risks of PPM implantation (within 90 days) and mortality following TAVR were compared for patients with and without post-TAVR RBBB using Kaplan-Meier analysis and Cox proportional hazards modeling. The risks of PPM implantation (within 90 days) and mortality following TAVR were compared for patients with and without post-TAVR RBBB using Kaplan-Meier analysis and Cox proportional hazards modeling. RESULTS: Of 1992 patients, 15 (0.75%) experienced new RBBB post-TAVR. There was a higher degree of valve oversizing among patients with new RBBB post-TAVR versus those without (17.9% versus 10.0%; P=0.034). Ten patients (66.7%) with post-TAVR RBBB experienced high-grade atrioventricular block and underwent PPM implantation (median 1 day; Q1, 0.2 and Q3, 4), compared with 268/1977 (13.6%) without RBBB. Following propensity score adjustment for covariates (age, sex, balloon-expandable valve, annulus diameter, and valve oversizing), post-TAVR RBBB was significantly associated with PPM implantation (hazard ratio, 8.36 [95% CI, 4.19-16.7]; P<0.001). No statistically significant increase in mortality was seen with post-TAVR RBBB (hazard ratio, 0.83 [95% CI, 0.33-2.11]; P=0.69), adjusting for age and sex. CONCLUSIONS: Although infrequent, post-TAVR RBBB was associated with elevated PPM implantation risk. The mechanisms for its development and its clinical prognosis require further study.

Impact of Inner Layer Renorrhaphy Suture on Renal Artery Pseudoaneurysm Formation Following Robotic-assisted Partial Nephrectomy.

OBJECTIVE: To report the impact of resection base inner layer renorrhaphy suture type on renal artery pseudoaneurysm (RAP) rate following robotic-assisted partial nephrectomy (RAPN). METHODS: Five hundred and sixty-three consecutive RAPNs performed by a single surgeon were retrospectively reviewed. Patients were classified into 3 categories: (1) No base suture, (2) monofilament barbed suture (2-0 V-Loc 180 absorbable suture, Medtronic, Minneapolis, MN), (3) polyglactin 910 (2-0 Vicryl coated suture, Ethicon Inc, Cincinnati, OH). In a secondary analysis, we evaluated suturing (Vicryl and V-Loc) vs no base suture. All patients had outer cortical renorrhaphy performed with 0-Vicryl suture utilizing the standard sliding clip technique. RESULTS: One hundred ten patients (19.5%) had V-Loc suturing, 255 patients (45.3%) had Vicryl suturing, and 198 patients (35.2%) had no base suture. Patients had a median age of 62.8years (interquartile range: 53.5-69.7) and median RENAL score was 8 (6-9). Median mass size from preoperative imaging was 3.0 cm (2.5-4.0) for V-Loc, 3.3 cm (2.5-4.2) for Vicryl, and 2.0 cm (1.8-3.0) for no base suture (P < .001). Overall, 21 patients (3.7%) developed a symptomatic postoperative RAP. The rate of RAP was 3.6% (4/110) for V-Loc, 3.9% (10/255) for 2-0 Vicryl, and 3.5% (7/198) for no base suture (P = 1.00). Similarly, the rate of RAP was 3.5% (7/198) for no base suture and 3.8% (14/365) for base suture (P = 1.00). CONCLUSION: Utilization of base suture and type of base suture used during RAPN was not predictive of postoperative RAP development.

Impact of Pulmonary Hypertension Hemodynamic Phenotype on Incident Atrial Fibrillation.

INTRODUCTION: Atrial fibrillation/flutter (AF) is common among patients with pulmonary hypertension (PH) and is associated with poor clinical outcomes. AF has been shown to occur more commonly among patients with postcapillary PH, although AF also occurs among patients with precapillary PH. The goal of this study was to evaluate the independent impact of PH hemodynamic phenotype on incident AF among patients with PH. METHODS: We retrospectively identified 262 consecutive patients, without a prior diagnosis of atrial arrhythmias, seen at the PH clinic at Mayo Clinic, Florida, between 1997 and 2017, who had right heart catheterization and echocardiography performed, with follow-up for outcomes through 2021. Kaplan-Meier analysis and Cox-proportional hazards regression modeling were used to evaluate the independent effect of PH hemodynamic phenotype on incident AF. RESULTS: Our study population was classified into two broad PH hemodynamic groups: precapillary (64.9%) and postcapillary (35.1%). The median age was 59.5 years (Q1: 48.4, Q3: 68.4), and 72% were female. In crude models, postcapillary PH was significantly associated with incident AF (HR 2.17, 95% CI: 1.26-3.74, p = 0.005). This association was lost following multivariable adjustment, whereas left atrial volume index remained independently associated with incident AF (aHR 1.30, 95% CI: 1.09-1.54, p = 0.003). CONCLUSION: We found PH hemodynamic phenotype was not significantly associated with incident AF in our patient sample; however, echocardiographic evidence of left atrial remodeling appeared to have a greater impact on AF development. Larger studies are needed to validate these findings and identify potential modifiable risk factors for AF in this population.

Analysis of Transurethral Resection of Bladder Tumor Efficiency Utilizing Nonprocedural Operating Room Times.

OBJECTIVE: To analyze the contribution of nonprocedural operating room (OR) times to transurethral resection of bladder tumor (TURBT) operative efficiency. METHODS: Over a 24-month period, all nonprocedural OR times from TURBT surgeries performed at a single institution were prospectively collected. Nonprocedural times included: in-room to anesthesia release time, anesthesia release to cut time, and close to wheels out time. Procedural OR time was cut to close time. We also analyzed the impact of time of day on TURBT efficiency (morning vs afternoon). Comparisons between groups were made using the Wilcoxon rank sum test for continuous variables. RESULTS: We identified 777 consecutive TURBT procedures from 2019 to 2020. The median total OR time was 63 minutes (interquartile range: 50-81 minutes). The nonprocedural time occupied a median of 49.4% of the total operating time (interquartile range: 38.9%-60.4%). Median anesthesia release to cut time was slower when 1 TURBT was performed a day compared to 2 or more (13 minutes vs 12 minutes, P = .04). Median close to wheels out time was faster when there was 1 TURBT in a day (7 minutes vs 8 minutes, P = .02). Median in-room to anesthesia release time was faster in the morning than it was in the afternoon (10 minutes vs 11 minutes, P = .02). CONCLUSION: Nonprocedural times made up roughly half of the total TURBT operating time and should be considered in OR efficiency analyses. TURBT OR efficiency may be related to the number of TURBTs performed in a day as well as the time of day of TURBT start.

Non-invasive detection of cardiac allograft rejection among heart transplant recipients using an electrocardiogram based deep learning model.

Aims: Current non-invasive screening methods for cardiac allograft rejection have shown limited discrimination and are yet to be broadly integrated into heart transplant care. Given electrocardiogram (ECG) changes have been reported with severe cardiac allograft rejection, this study aimed to develop a deep-learning model, a form of artificial intelligence, to detect allograft rejection using the 12-lead ECG (AI-ECG). Methods and results: Heart transplant recipients were identified across three Mayo Clinic sites between 1998 and 2021. Twelve-lead digital ECG data and endomyocardial biopsy results were extracted from medical records. Allograft rejection was defined as moderate or severe acute cellular rejection (ACR) based on International Society for Heart and Lung Transplantation guidelines. The extracted data (7590 unique ECG-biopsy pairs, belonging to 1427 patients) was partitioned into training (80%), validation (10%), and test sets (10%) such that each patient was included in only one partition. Model performance metrics were based on the test set (n = 140 patients; 758 ECG-biopsy pairs). The AI-ECG detected ACR with an area under the receiver operating curve (AUC) of 0.84 [95% confidence interval (CI): 0.78-0.90] and 95% (19/20; 95% CI: 75-100%) sensitivity. A prospective proof-of-concept screening study (n = 56; 97 ECG-biopsy pairs) showed the AI-ECG detected ACR with AUC = 0.78 (95% CI: 0.61-0.96) and 100% (2/2; 95% CI: 16-100%) sensitivity. Conclusion: An AI-ECG model is effective for detection of moderate-to-severe ACR in heart transplant recipients. Our findings could improve transplant care by providing a rapid, non-invasive, and potentially remote screening option for cardiac allograft function.

Analysis of fixed and variable operating room (or) time point efficiency in partial nephrectomies: open versus robotic-assisted.

To analyze operating room (OR) efficiency by evaluating fixed and variable OR times for open (OPN) and robotic-assisted partial nephrectomies (RAPN). We analyzed consecutive OPN and RAPN performed by one surgeon over a 24-month period. All patients were placed in the lateral decubitus position and secured with a beanbag regardless of approach. Fixed (non-procedural) OR times were prospectively collected and defined as: in-room to anesthesia-release time (IRAT), anesthesia release to cut time (ARCT), and close to wheels-out time (CTWO). Variable OR time was procedural cut to close time (CTCT). Comparisons of fixed and variable OR time points between OPN and RAPN were performed using the Wilcoxon rank-sum test. 146 RAPN and 31 OPN were evaluated from 2019-2020. Median IRAT was similar for RAPN versus OPN [20 min (IQR: 16-25) vs. 20 min (IQR: 16-26), P = 0.57]. Median ARCT was longer for RAPN than it was for OPN [40 min (IQR: 36-46) vs. 34 min (IQR: 30-39), P < 0.001]. Median CTWO was similar for OPN (12 min, IQR: 9-14) and RAPN (11 min, IQR: 7-15) (P = 0.89). Median CTCT was longer for RAPN (202 min, IQR: 170-236) compared to OPN (164 min, IQR: 154-184) (P < 0.001). In a single surgeon, partial nephrectomy series with the same patient positioning, utilization of robotic technology was associated with longer surgeon operating time as well as less efficient fixed OR times, specifically ARCT.

A retrospective analysis of the prevalence and impact of associated comorbidities on fibromyalgia outcomes in a tertiary care center.

Background: This retrospective study was designed to analyze the prevalence and impact of associated comorbidities on fibromyalgia (FM) outcomes (functionality, pain, depression levels) for patients who participated in an intensive multicomponent clinical program in a tertiary care center. Methods: Participants included a sample of 411 patients diagnosed with FM at a large tertiary medical center using the 2016 ACR criteria. Patients completed an intensive 2-day cognitive behavioral treatment (CBT) program, filled out the Fibromyalgia Impact Questionnaire Revised (FIQR), the Center for Epidemiologic Studies Depression Scale (CES-D), the Pain Catastrophizing Scale (PCS), and were followed for 6 months after treatment completion. T-tests were performed to analyze differences between the presence or absence of select comorbidities for the three outcomes at follow-up. Statistically significant comorbidities (p < 0.05) were used as predictors in multivariable logistic regression models. Results: The FM associated comorbidities in this cohort that had significant impact on the measured outcome domains after treatment program completed were Obesity (FIQR p = 0.024), Hypothyroidism (CES-D p = 0.023, PCS p = 0.035), Gastroesophageal reflux disease GERD (PCS p < 0.001), Osteoarthritis (CES-D p = 0.047). Interestingly, Headache, the most frequent FM associated comorbidity in this cohort (33.6%), did not have a significant impact on the outcome domains at follow-up. Obesity (18.2%) was the only FM associated comorbidity significantly impacting all three outcome domains at follow-up. Conclusion: The present study suggests that addressing obesity may significantly impact outcomes in FM patients.

A deep learning approach for detecting liver cirrhosis from volatolomic analysis of exhaled breath.

Liver disease such as cirrhosis is known to cause changes in the composition of volatile organic compounds (VOC) present in patient breath samples. Previous studies have demonstrated the diagnosis of liver cirrhosis from these breath samples, but studies are limited to a handful of discrete, well-characterized compounds. We utilized VOC profiles from breath samples from 46 individuals, 35 with cirrhosis and 11 healthy controls. A deep-neural network was optimized to discriminate between healthy controls and individuals with cirrhosis. A 1D convolutional neural network (CNN) was accurate in predicting which patients had cirrhosis with an AUC of 0.90 (95% CI: 0.75, 0.99). Shapley Additive Explanations characterized the presence of discrete, observable peaks which were implicated in prediction, and the top peaks (based on the average SHAP profiles on the test dataset) were noted. CNNs demonstrate the ability to predict the presence of cirrhosis based on a full volatolomics profile of patient breath samples. SHAP values indicate the presence of discrete, detectable peaks in the VOC signal.

Validation of new baseline renal function predictive model in robotic-assisted partial nephrectomy cohort.

OBJECTIVE: To validate a new baseline estimated glomerular filtration rate (NB-GFR) formula in a cohort of robotic-assisted partial nephrectomies (RAPN). METHODS: NB-GFR = 35 + preoperative GFR (× 0.65) - 18 (if radical nephrectomy) - age (× 0.25) + 3 (if tumor size >7 cm) - 2 (if diabetes). NB-GFR was calculated in 464 consecutive RAPN from a single surgeon cohort. 143 patients were excluded secondary to insufficient eGFR follow up. We analyzed NB-GFR accuracy utilizing the last observed eGFR 3-12 months post RAPN. Categorical variables were summarized with the frequency and percentage of patients. Numerical variables were summarized with the median, 25th percentile, and 75th percentile. RESULTS: The mean difference between observed and predicted NB-GFR was 4.6 ml/min/1.73m2 (95% CI -6.9 to 16.1 ml/min/1.73m2 ). There was a pattern of higher observed NB-GFRs being underestimated by the NB-GFR equation while lower observed NB-GFRs were overestimated by the NB-GFR equation. The NB-GFR formula had a high level of accuracy with 98.8% of predicted NB-GFRs falling within 30% of the observed NB-GFR (95% CI 86.8% to 99.5%). The median and interquartile range of the difference between observed and predicted NB-GFR was 3.9 ml/min/1.73m2 (IQR 0.7 to 8.2 ml/min/1.73m2 ). The sensitivity, specificity, positive predictive value, and negative predictive value for the ability of predicted NB-GFR to identify those with an observed NB-GFR <60 ml/min/1.73m2 after RAPN was 98%, 92%, 88%, and 99%, respectively. CONCLUSION: The NB-GFR equation developed with partial and radical nephrectomy cohorts is accurate in predicting post-operative eGFR 3-12 months following RAPN.

Depression: A Modifiable Risk Factor for Poor Outcomes in Fibromyalgia.

BACKGROUND: About 4 out of 10 fibromyalgia patients suffer from depression. The European Alliance of Associations for Rheumatology (EULAR) guidelines recommend using antidepressants to treat fibromyalgia. OBJECTIVE: To determine predictors of improved outcomes following a multicomponent treatment program. DESIGN: We designed this longitudinal treatment outcome study to evaluate the prevalence of depression symptoms in patients diagnosed with fibromyalgia at a tertiary care facility, and the impact of depression on functional outcomes after completing a multicomponent fibromyalgia treatment program. SETTING: Tertiary care center. PATIENTS: This study included 411 adult patients with fibromyalgia who completed a multicomponent treatment program for fibromyalgia. Expert physicians performed comprehensive evaluations following American College of Rheumatology (ACR) criteria to confirm fibromyalgia before referral to the program. INTERVENTION: An intensive outpatient multicomponent treatment program consisting of 16 hours of cognitive behavioral strategies served as the intervention. MEASUREMENTS: Functional status was assessed using the Fibromyalgia Impact Questionnaire Revised (FIQR). Depression was evaluated with the Center for Epidemiologic Study of Depression (CES-D) measure. Measures were administered prior to participation in the program and approximately 5 months following completion of the program. RESULTS: The cohort had a high prevalence of depressive symptoms (73.2% had depression at admission). Higher depression scores at baseline predicted poorer outcomes following multi-component treatment. Effectively treated depression resulted in improved functioning at follow-up. LIMITATIONS: Findings limited to tertiary care center cohort of fibromyalgia patients. Patients did not undergo a structured clinical diagnostic interview to diagnose depression. CONCLUSIONS: The current data links depression to poorer outcomes in patients with fibromyalgia. Depression is an important modifiable factor in the management of fibromyalgia. Guidelines should reflect the importance of assessing and effectively treating depression at the time of diagnosis of fibromyalgia, to improve functional outcomes. REGISTRATION: Specific registry and specific study registration number-Institutional Review Board-(IRB# 19-000495). FUNDING SOURCE: No funding.

Analysis of Holmium Laser Enucleation of Prostate Fixed Operating Room Times.

OBJECTIVE: To evaluate factors influencing fixed operating room time during holmium laser enucleation of the prostate. MATERIALS AND METHODS: A prospective observational study was performed for all holmium laser enucleation of the prostate (HoLEP) cases performed by a single surgeon over a 24-month period. Operating room (OR) time was divided into fixed and variable time. The variable time was defined as cut-to-close time. Fixed time included in room time to anesthesia release time (IRAT), anesthesia release time to cut time (ARCT), and close time to wheels out (CTWO). The effects of time of day and anesthesia personnel (AP) changes on fixed operating room time were evaluated. RESULTS: A total of 406 HoLEPs were analyzed. There was no statistically significant difference in nonprocedural OR times between morning and afternoon surgeries (IRAT, P = .38, ARCT P = .10, CTWO P = .77). Median nonprocedural OR times accounted for 27% (IQR: 22%-31%) of the total procedure time in the AM group and 29% (IQR: 24%-33%) in the PM group (P = .005). Of the HoLEPs,78.1% (178/228) experienced one or more AP changes during the procedure. The median fixed OR time was not significantly different between procedures with 1 AP and procedures with ≥2 APs (IRAT, P = .53; ARCT, P = .71; CTWO, P = .98). CONCLUSION: Fixed operating room time makes up a significant portion of HoLEP procedures and should be considered when evaluating OR efficiency. The time of day and number of anesthesia personnel involved did not affect the fixed OR times.

Impact of Severe Acute Respiratory Syndrome Coronavirus 2-Induced COVID-19 on Fixed Operating Room Times in Urologic Operations.

Objective: To evaluate the impact of coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2, on operating room (OR) efficiency for urologic procedures using the concept of fixed OR times. Patients and Methods: Over a 24-month period, urology OR data were prospectively collected. Operations were divided into fixed and variable time points. The fixed OR times were in-roomw to anesthesia-release time, anesthesia-release to cut time, in-room to cut time, and close to wheels-out time. Data from January 1, 2019, to December 31, 2019, were pre-COVID-19 data, and data from April 1, 2020, to December 31, 2020, were post-COVID-19 data. Operations were grouped into endoscopic, implant, major open, and robotic-assisted cases. In the post-COVID-19 era, all patients had a negative polymerase chain reaction test result within 48 hours of operation. The Wilcoxon rank sum test was used to compare the fixed OR times between the pre- and post-COVID-19 eras. Results: A total of 3189 procedures were evaluated: 2058 endoscopic operations (1124 in the pre-COVID-19 era and 934 in the post-COVID-19 era), 343 implant procedures (192 in the pre-COVID-19 era and 151 in the post-COVID-19 era), 222 major open procedures (119 in the pre-COVID-19 era and 103 in the post-COVID-19 era), and 566 robotic-assisted procedures (338 in the pre-COVID-19 era and 228 in the post-COVID-19 era). There were no fixed OR times in any of the examined groups that were negatively impacted by COVID-19. The percentage of the total OR time occupied by fixed OR variables in the pre-COVID-19 era was 40.6% for endoscopic operations, 41.1% for implant procedures, 29.8% for major open procedures, and 21.8% for robotic-assisted procedures. Conclusion: A substantial portion of the total OR time includes fixed time points. Furthermore, COVID-19 did not have a negative impact on fixed OR times in a negative testing environment. Urologic OR efficiency should be maintained in the post-COVID-19 era.

Optimized Surveillance Intervals Following Endoscopic Eradication of Dysplastic Barrett's Esophagus: An International Cohort Study.

BACKGROUND & AIMS: Recommended surveillance intervals after complete eradication of intestinal metaplasia (CE-IM) after endoscopic eradication therapy (EET) are largely not evidence-based. Using recurrence rates in a multicenter international Barrett's esophagus (BE) CE-IM cohort, we aimed to generate optimal intervals for surveillance. METHODS: Patients with dysplastic BE undergoing EET and achieving CE-IM from prospectively maintained databases at 5 tertiary-care centers in the United States and the United Kingdom were included. The cumulative incidence of recurrence was estimated, accounting for the unknown date of actual recurrence that lies between the dates of current and previous endoscopy. This cumulative incidence of recurrence subsequently was used to estimate the proportion of patients with undetected recurrence for various surveillance intervals over 5 years. Intervals were selected that minimized recurrences remaining undetected for more than 6 months. Actual patterns of post-CE-IM follow-up evaluation are described. RESULTS: A total of 498 patients (with baseline low-grade dysplasia, 115 patients; high-grade dysplasia [HGD], 288 patients; and intramucosal adenocarcinoma [IMCa], 95 patients) were included. Any recurrence occurred in 27.1% and dysplastic recurrence occurred in 8.4% over a median of 2.6 years of follow-up evaluation. For pre-ablation HGD/IMCa, intervals of 6, 12, 18, and 24 months, and then annually, resulted in no patients with dysplastic recurrence undetected for more than 6 months, comparable with current guideline recommendations despite a 33% reduction in the number of surveillance endoscopies. For pre-ablation low-grade dysplasia, intervals of 1, 2, and 4 years balanced endoscopic burden and undetected recurrence risk. CONCLUSIONS: Lengthening post-CE-IM surveillance intervals would reduce the endoscopic burden after CE-IM with comparable rates of recurrent HGD/IMCa. Future guidelines should consider reduced surveillance frequency.

Comparative study of therapy-related and de novo adult b-cell acute lymphoblastic leukaemia.

We report a comparative analysis of patients with therapy-related acute lymphoblastic leukaemia (tr-ALL) vs de novo ALL. We identified 331 patients with B-ALL; 69 (21%) were classified as tr-ALL. The most common prior malignancies were breast (23·2%) and plasma cell disorders (20·3%). Patients with tr-ALL were older (median 63·2 vs. 46·2 years, P < 0.001), more often female (66·7% vs. 43·5%, P < 0·001), and more likely to have hypodiploid cytogenetics (18·8% vs. 5·0%, P < 0·001). In multivariable analysis, patients with tr-ALL were less likely to achieve complete remission [odds ratio (OR) = 0·16, P < 0·001] and more likely to be minimal residual disease-positive (OR = 4·86, P = 0·01) but had similar OS after diagnosis and allo-haematopoietic cell transplantation.

Analysis of Operating Room Efficiency During Robot-Assisted Urologic Surgeries Utilizing Fixed (Nonprocedural) Operative Times.

Objective: To analyze operating room (OR) efficiency by evaluating fixed OR times for three common urologic robot-assisted procedures. Methods: Over a 24-month period, we prospectively collected intraoperative data for 635 consecutive robot-assisted surgeries. Fixed (nonprocedural) OR times were evaluated for robot-assisted partial nephrectomy (RAPN) (n = 146), robot-assisted radical cystectomy (RARC) (n = 77), and robot-assisted radical prostatectomy (RARP) (n = 412). Fixed OR times were defined as nonprocedural time in the OR, including in-room time to anesthesia release time (IRAT), anesthesia release to cut time (ARCT), in-room time to cut time (IRCT; IRAT+ARCT), and close time to wheels out time (CTWO). The effects of operation time of day and the number of anesthesia personnel (AP) present in procedure on fixed OR times were also analyzed. Results: Fixed OR times occupied 15.1% (IQR: 12.9%-17.1%) (RARC), 26.6% (22.9%-30.8%) (RAPN), and 20.1% (17.4%-23.1%) (RARP) of total OR time. Time of day did not have a negative effect on fixed OR times for robotic urologic surgeries. Median AP count was highest for RARC (median: 3 and range: 1-7). We did not find any association between AP count and fixed OR times for any of the procedures (p ≥ 0.19). Conclusions: Fixed OR times made up a significant percentage of total OR time for robot-assisted procedures and should be incorporated into OR efficiency analyses. The number of AP per case and time of day of procedure did not negatively impact fixed OR times in urologic robotic surgeries.

Access to and safety of COVID-19 convalescent plasma in the United States Expanded Access Program: A national registry study.

BACKGROUND: The United States (US) Expanded Access Program (EAP) to coronavirus disease 2019 (COVID-19) convalescent plasma was initiated in response to the rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19. While randomized clinical trials were in various stages of development and enrollment, there was an urgent need for widespread access to potential therapeutic agents. The objective of this study is to report on the demographic, geographical, and chronological characteristics of patients in the EAP, and key safety metrics following transfusion of COVID-19 convalescent plasma. METHODS AND FINDINGS: Mayo Clinic served as the central institutional review board for all participating facilities, and any US physician could participate as a local physician-principal investigator. Eligible patients were hospitalized, were aged 18 years or older, and had-or were at risk of progression to-severe or life-threatening COVID-19; eligible patients were enrolled through the EAP central website. Blood collection facilities rapidly implemented programs to collect convalescent plasma for hospitalized patients with COVID-19. Demographic and clinical characteristics of all enrolled patients in the EAP were summarized. Temporal patterns in access to COVID-19 convalescent plasma were investigated by comparing daily and weekly changes in EAP enrollment in response to changes in infection rate at the state level. Geographical analyses on access to convalescent plasma included assessing EAP enrollment in all national hospital referral regions, as well as assessing enrollment in metropolitan areas and less populated areas that did not have access to COVID-19 clinical trials. From April 3 to August 23, 2020, 105,717 hospitalized patients with severe or life-threatening COVID-19 were enrolled in the EAP. The majority of patients were 60 years of age or older (57.8%), were male (58.4%), and had overweight or obesity (83.8%). There was substantial inclusion of minorities and underserved populations: 46.4% of patients were of a race other than white, and 37.2% of patients were of Hispanic ethnicity. Chronologically and geographically, increases in the number of both enrollments and transfusions in the EAP closely followed confirmed infections across all 50 states. Nearly all national hospital referral regions enrolled and transfused patients in the EAP, including both in metropolitan and in less populated areas. The incidence of serious adverse events was objectively low (<1%), and the overall crude 30-day mortality rate was 25.2% (95% CI, 25.0% to 25.5%). This registry study was limited by the observational and pragmatic study design that did not include a control or comparator group; thus, the data should not be used to infer definitive treatment effects. CONCLUSIONS: These results suggest that the EAP provided widespread access to COVID-19 convalescent plasma in all 50 states, including for underserved racial and ethnic minority populations. The study design of the EAP may serve as a model for future efforts when broad access to a treatment is needed in response to an emerging infectious disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT#: NCT04338360.