Single-institution Prospective Cohort Study Research Articles

Clinical Signs and Treatment of New-Onset Bone Marrow Failure Associated SARS-CoV-2 Infection in Children: A Single Institution Prospective Cohort Study.

Viral infections can cause direct and indirect damage to hematopoietic stem cells. The objectives of this study were to identify the frequency and severity of aplastic anemia in children infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as well as recognize the response to treatment. 13 children with newly diagnosed severe aplastic anemia were enrolled in this prospective clinical trial. Blood samples were obtained from all patients to detect SARS-CoV-2 antibodies, and nasopharyngeal swabs were collected for reverse-transcription Polymerase Chain Reaction to detect SARS-CoV-2 viruses. According to the laboratory results, patients were classified as having SARS-CoV-2 positive antibodies and SARS-CoV-2 negative antibodies. Both groups received combined cyclosporine (CsA) + Eltrombopag (E-PAG). The hematological response, either complete response (CR) or partial response (PR), no response (NR), and overall response (OR) rates of combined E-PAG + CsA treatment after 6 months were evaluated. Four children were recognized to have aplastic anemia and SARS-CoV-2 positive antibodies. Two patients fulfilled the hematological criteria for CR and no longer required transfusion of packed red blood cells (PRBCs) or platelets, and one had PR and was still PRBC transfusion-dependent but no longer required platelet transfusion. The remaining patient showed NR, and he had died before reaching the top of the HSCT waiting list. Moreover, six patients in the SARS-CoV-2 negative antibodies group had CR, while three patients had PR. The difference in ANC, Hg, and platelet counts between both groups was not significant. The SARS-CoV-2 virus is added to several viral infections known to be implicated in the pathogenesis of aplastic anemia. Studies are needed to establish a definitive association and determine whether the response of bone marrow failure to standard therapy differs from that of idiopathic cases.

D-dimer and sinusoidal obstructive syndrome-novel poor prognostic features of thrombotic microangiopathy in children after hematopoietic cellular therapy in a single institution prospective cohort study.

Transplant-associated thrombotic microangiopathy (TA-TMA) is a common, severe complication of allogeneic hematopoietic cellular therapy (HCT). Even when treated in many studies, morbidity and mortality rates are high. This prospective single-institution cohort study serially enrolled all allogeneic HCT recipients from August 2019-August 2022. Patients were universally screened for TA-TMA and intermediate and high-risk patients were immediately treated with eculizumab. Sub-distribution cox-proportional hazards modelswere used to identify sub-distribution hazard ratios (sHR) for multi-organ dysfunction (MOD) and non-relapse-related mortality (NRM). Of 136 patients, 36 (26%) were diagnosed with TA-TMA and 21/36 (58%) developed MOD, significantly more than those without TA-TMA, (p < .0001). Of those with TA-TMA, 18 (50%) had high-risk TA-TMA (HR-TA-TMA), 11 (31%) had intermediate-risk TA-TMA (IR-TA-TMA), and 8 (22%) had standard risk (SR-TA-TMA). Twenty-six were treated with eculizumab (1/8 SR, 7/11 IR, and 18/18 HR). Elevated D-dimer predicted the development of MOD (sHR 7.6, 95% confidence interval [CI] 1.8-32.3). Children with concurrent sinusoidal obstructive syndrome (SOS) and TA-TMA had an excess risk of MOD of 34% and data supported a biologic interaction. The adjusted NRM risk was significantly higher in the TA-TMA patients (sHR 10.54, 95% CI 3.8-29.2, p < .0001), despite prompt treatment with eculizumab. Significant RF for NRM in TA-TMA patients included SOS (HR 2.89, 95% 1.07-7.80) and elevated D-dimer (HR 3.82, 95% CI 1.14-12.84). An unrelated donor source and random urine protein to creatine ratio ≥2 mg/mg were significantly associated with no response to eculizumab (odds ratio 15, 95% CI 2.0-113.6 and OR 6.5, 95% CI 1.1-38.6 respectively). TA-TMA was independently associated with NRM despite early diagnosis and treatment with eculizumab in this large pediatric transplant cohort. Prognostic implications of D-dimer in TA-TMA merit further investigation as this is a readily accessible biomarker. Concurrent SOS is an exclusion criterion of many ongoing clinical trials, but these data highlight these patients could benefit from novel therapeutic approaches. Multi-institutional clinical trials are needed to understand the impact of TA-TMA-targeted therapies.

Frailty screening for determination of hemodialysis access placement

ObjectiveChoosing the right hemodialysis vascular access for frail patients remains difficult because the patient's preferences and the likelihood of access function and survival must be considered. We hypothesize that patients identified before arteriovenous (AV) access as frail by the PRISMA-7 score may have worse outcomes, indicating that fistula creation may not be the most clinically beneficial option and it would be in the best interest of the patient to receive either AV graft (AVG) placement or dialysis through a percutaneous catheter. Our pilot study aims to determine whether an association exists between patient frailty as defined by PRISMA-7 and newly created AV fistula (AVF) and AVG access outcomes. MethodsThis was a single institutional prospective cohort study of patients undergoing new AVF or AVG intervention from April 2021 to May 2023. Patients were assessed using the PRISMA-7 frailty questionnaire before their AV access surgery. Patients were grouped by frailty score and score groups were examined for trends. Univariable analysis was performed for baseline differences between frail and nonfrail patients. Failure to achieve maturation, postoperative infection, and 180-day mortality difference was also investigated for frail vs nonfrail patients. Univariable analysis was performed for nonmaturation using standard comorbidities, arterial and venous diameters, and frailty. Multivariable binary logistic regression was performed for the outcome of nonmaturation using frailty as one of the variables in conjunction with the univariable risks associated with nonmaturation. ResultsA total of 40 patients undergoing new AV access placement were investigated, among whom 53% were designated as frail (PRISMA-7 score ≥3). When comparing the frail and nonfrail new AV access groups, the access (AVF and AVG combined) failed in 48% (10/21) of the frail patients, but only failed in 5% (1/19) of the nonfrail patients 1 (P = .012). When distinguishing between AV access types, AVF creations followed the overall trend with 60% of AVF access (9/15) sites in frail patients failing to mature when compared with nonfrail patients, who all had fistulas that matured to use (P = .049). Surgical site infection was absent in all frail patients and present in 5% of nonfrail patients (1/19). Both 30-day and 60-day readmission rates were higher in the frail group compared with the nonfrail group. There was 180-day mortality present in 5 of frail patients % (1/21) and absent in nonfrail patients. Multivariable analysis revealed that both frailty (adjusted odd ratio, 10.19; 95% confidence interval, 1.20-82.25); P = .033) and younger age (adjusted odd ratio, 0.953; 95% confidence interval, 0.923-0.983; P = .002) both had a significant association with nonmaturation. Power analysis revealed a power statistic of 0.898 indicating a probability of type 2 error of 10.02% with a P value of .002. Hosmer-Lemeshow goodness of fit for the logistic regression had 75% overall accuracy for the model. ConclusionsPatient frailty is significantly associated with an increased incidence of AV access failure to mature.

Single Anastomosis Duodenal Switch versus Classic Duodenal Switch: Long-term Outcomes from a Prospective Comparative Cohort Study.

The literature on long-term outcomes of duodenal switch (DS) compared to single anastomosis duodenal switch (SADI-S) procedures is lacking. We evaluated the long-term outcomes of SADI-S compared to those after the classic DS procedure. This is a follow-up report from a single-institution prospective cohort study comparing long-term outcomes of SADI-S versus DS both as one- and two-stage procedures (ClinicalTrials.gov: NCT02792166). Data is depicted as count (percentage) or median (interquartile range). Forty-two patients underwent SADI-S, of whom 11 had it as a second-stage procedure (26%). Of 20 patients who underwent DS, twelve had it as a second-stage procedure (60%). Both groups were similar at baseline. Median follow-up times for one-stage SADI-S and DS were 57 (24) and 57 (9) months, respectively (p = 0.93). Similar BMI reductions were observed after one-stage SADI-S (16.5kg/m2 [8.5]) and DS (18.9kg/m2 [7.2]; p = 0.42). At median follow-up of 51 (21) and 60 (15) months after second-stage SADI-S and DS, respectively (p = 0.60), surgical procedures yielded reductions in BMI of 20.5kg/m2 (14.0) and 24.0kg/m2 (13.9), respectively (p = 0.52). Follow-up rates were similar for one-stage (≥ 88%; p = 0.29) and second-stage procedures (≥ 83%; p = 0.16). Similar diabetes and hypertension remissions were found (p = 0.77; P = 0.54, respectively). Despite fat-soluble vitamin deficiencies at baseline, after supplementation, they were either eliminated or less prevalent long-term after SADI-S. Daily bowel movements were also less frequent. Long-term weight and comorbidity outcomes after SADI-S are similar to those of DS both as one- and two-stage surgeries. SADI-S procedure may allow for similar beneficial outcomes with less burden from gastrointestinal symptoms and fat-soluble vitamin deficiencies.

High symptom burden in patients undergoing gastrectomy for cancer.

There islittle data describing symptom burden before or after gastrectomy for patients with cancer. We aimed to examine the perioperative patterns of symptom severity in patients undergoing gastrectomy. In this single-institution prospective cohort study, patients scheduled to undergo gastrectomy for cancer completed serial symptom measurement questionnaires preoperatively, at postoperative day (POD) 1-3, and POD 4-7. The percent of patients with moderate to severe scores wascalculated at each time point. Thirty-ninepatients completed 94 surveys. Preoperatively, 46% reported at least one moderate/severe symptom. This increased to 88% during POD 1-3and 79% during POD 4-7. During the preoperative period, 25% of patients reported moderate to severe interference in at least one aspect of daily life. This increased to 73% of patients at both POD 1-3 and POD 4-7. Patients undergoing gastrectomy for cancer frequently experience symptoms that interfere with daily life. A better understanding of these symptoms may improve patients' experiences with, and recovery from, gastrectomy.

Alternative treatment modality for severe aplastic anemia in a resource-limited setting: a single-institution prospective cohort study from Upper Egypt

This study compared the efficacy and safety of CsA monotherapy with eltrombopag (E-PAG) + CsA combined treatment in children with severe aplastic anemia (SAA). The study including 30 children had SAA. Ten were a retrospective cohort treated with CsA monotherapy. The other 20 were prospective cohort received E-PAG + CsA. All patients were evaluated for partial (PR) and complete (CR) hematological response at 3, 6, and 12 months. overall response (OR), overall survival rates (OS), and treatment safety. OR for the E-PAG patients was 40% after 3 months of therapy. At 6 months, this had increased to 75% with significantly higher CR rate (40%) than in the CsA group (p = 0.0001). After a year of treatment, the CR for the E-PAG + CsA regimen had increased to 50% and the OR to 85%, compared to 20% in the CsA group (p = 0.0001). The OS at 12 months was 100% in the E-PAG+ CsA group compared to 80% in the CsA cohort. At 24 months, the OS in the E-PAG + CsA group was 90%. In conclusion, E-PAG+ CsA was found to be a safe and effective alternative treatment for children with SAA particularly in countries with limited resources.

Safety of Hyperbaric Oxygenation Treatment and Evaluation of Associated Clinical Parameters: A Single-Institutional Prospective Cohort Study

Background and Objective: Adverse events (AEs) associated with hyperbaric oxygen therapy (HBOT) are uncommon and typically not serious, being the most frequent otic/sinus barotrauma. The objective of this study is to analyze the safety of the HBOT at 1.45 atmosphere absolute (ATA) and compare it with reportsat the same and higher pressures of treatment. AE per session was 7.1% for total AE and 4.1% for overall barotrauma. AE was reported in 28.3% of patients (n=49), with barotrauma and non-barotrauma AE in 20.3% (n=35) and 8.1% (n=14). All barotrauma was recorded as subjective (100% of ear ache without eardrum damage, Teed scale=0). The frequency of total AE obtained in our study was statistically higher for 1.5, 2, and &gt;2 ATA. Non-barotrauma AE was also higher; the frequency of total AE obtained in our study was statistically significant for 1.5, 2, and &gt;2 ATA but objective barotrauma was not present, and it was significantly lower than previously reported (p &lt; 0.001). A very slow rate of pressurizations (below 1 psi/min) was associated with ear pain (OR=3.32; 95 CI%, 1.32-8.35; p &lt; 0.001). The AEs reported in this safety surveillance prospective study are minor, and no objective barotrauma was reported. HBOT at 1.45 ATA is a safe treatment, that can be performed with a portable light and a less expensive hyperbaric chamber. Methods: A total of 175 patients (68 male, 107 female) were included in this prospective study. All patients were treated with HBOT at our facility from December 2019 to August 2021. For the comparative analysis, reports from studies published from 2012 to 2021 in MEDLINE EMBASE, BIREME, Lilacs, Scielo, and the Cochrane library were used. Binary variables are described in percentages with a 95% confidence interval (95% CI). Inferential analysis was performed using a bivariate analysis by calculating odds ratio (OR) with 95% confidence intervals. Statistical analyses and sample size calculations were performed with Stata version 13.0 (College Station, TX, USA). Results: In this study, the AE per session was 7.1% for total AE and 4.1% for overall barotrauma. AE was reported in 28.3% of patients (n=49), with barotrauma and non-barotrauma AE in 20.3% (n=35) and 8.1% (n=14), respectively. All barotrauma was recorded as subjective (100% of ear ache without eardrum damage, Teed scale=0). The frequency of total AE obtained in our study was statistically higher for 1.5, 2, and &gt;2 ATA. Non-barotrauma AE was also higher, but objective barotrauma was not present and was significantly lower than previously reported (p &lt;0.001). A very slow rate of pressurizations (below 1psi/minute) was associated with ear pain (OR = 3.32; 95% CI, 1.32-8.35; p &lt;0.001). Conclusion and Implications for Translation: In this study, the AE reported in this prospective safety surveillance study are minor, and no objective barotrauma was reported. The HBOT at 1.45 ATA is a safe treatment that can be performed with a portable lighter and a less expensive hyperbaric chamber. This study supports the hypothesis that hyperbaric oxygenation therapy at 1.45 ATA is a safe treatment, allowing for the spread and application of adjuvant treatment in different pathologies.   Copyright © 2023 Monge-Martínez, et al. Published by Global Health and Education Projects, Inc. This is an open-access article distributed under the terms of the Creative Commons Attribution License CC BY 4.0.

LBA03-10 ROLE OF INTRAVESICAL BACILLE CALMETTE GUERIN(BCG) IN ERADICATING ASYMPTOMATIC BACTERIURIA IN BLADDER CANCER PATIENTS-A PROSPECTIVE STUDY

You have accessJournal of UrologyCME1 Apr 2023LBA03-10 ROLE OF INTRAVESICAL BACILLE CALMETTE GUERIN(BCG) IN ERADICATING ASYMPTOMATIC BACTERIURIA IN BLADDER CANCER PATIENTS-A PROSPECTIVE STUDY Ganesh Prasad Sankarapandian Ganesh Prasad SankarapandianGanesh Prasad Sankarapandian More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003426.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Although intravesical Bacille Calmette Guerin therapy for high grade superficial bladder cancer is not specifically contra indicated in people with asymptomatic bacteriuria, generally urologist are reluctant in administering this to such patients because of a possible risk of bacterial sepsis or BCG sepsis.On the other hand, anti bacterial treatment of asymptomatic bacteriuria leads to treatment delay and promotes tumour progresssion. This study is done to investigate whether intravesical BCG therapy alone can eradicate bacterial infection in asymptomatic bactreriuric patients on intravesical BCG therapy for bladder tumour. METHODS: A Single institutional prospective cohort study of bacteriuric adults with non muscle invasive bladder cancer who underwent outpatient based BCG intravesical therapy from November 2020 to November 2021 were followed up for one year till November 2022. 25 High grade non muscle invasive bladder cancer patients who underwent intravesical BCG therapy were compared with 25 low grade non muscle invasive bladder cancer patients. All patients had asymptomatic bacteriuria,none recieved antibiotic therapy before ,during or after cystoscopy procedure .Urine culture were repeated after 3,6 and 12 months after completion of one year post TURBT. All patients were followed up for a minimum of one year. The end point was number of patients who became bacteria free at 3,6,12 months. RESULTS: None of BCG treated patients, but three control patients developed febrile urinary tract infections and were removed from the study. Of the study group out of 25 patients who recieved intravesical BCG 20 were continuously bacteria free at the end of one year compared with 8 out of 22 patients in the control group. CONCLUSIONS: Intravesical BCG is associated with clearance of Uropathogens in bladder cancer patients possibly due to an augmented innate host immunity. Source of Funding: Self (Author) © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1196 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ganesh Prasad Sankarapandian More articles by this author Expand All Advertisement PDF downloadLoading ...

Abstract P5-09-03: Real World Data on Neoadjuvant Endocrine Treatment and Ki67 Assessment in ER+/HER2- Breast Cancer. Results from a Single-Institution Prospective Cohort Study

Abstract Purpose: Neoadjuvant endocrine treatment (NET) has become a useful tool for the downstaging of luminal-like breast cancers in postmenopausal patients. It enables us to increase breast conserving surgery (BCS) rates and provides an opportunity for assessing in vivo NET effectiveness and studying any biological changes that may act as valid biomarkers. The purpose of this study was to evaluate the effectiveness of NET as well as to assess the role of Ki67 proliferation rate changes as an indicator of endocrine responsiveness. Methods: From June 2016 to January 2022, a single-institution cohort of patients treated with NET and further surgery was evaluated. In patients with Ki67≥10%, a second core biopsy was performed after four weeks. Information regarding histopathological and clinical changes, as well as surgical management, was gathered. Results: A total of 168 estrogen receptor positive (ER+)/HER2 negative patients were included. The median age at diagnosis was 69.5 years old (IQR: 16.0). The median treatment duration was 5.0 months (IQR: 4.0). Median maximum size in the surgical sample was 44.0% smaller than pretreatment size measured by ultrasound (p&amp;lt;.0001), showing an inverse linear relationship with treatment duration. Median pretreatment Ki67 expression was 20.0% (IQR: 18.0) and was reduced to 5.0% (IQR: 8.0) after four weeks, and to 2.0% (IQR: 7.25) in the surgical sample (p&amp;lt; 0.0001). Other significant downgrading changes were observed with respect to tumor grade (p&amp;lt; 0.0001) and progesterone receptor (PR) expression (p&amp;lt; 0.0001). BCS was performed on 145 patients (86.3%). One case of pathological complete response was recorded. A larger Ki67 fold-change after four weeks was significantly related to a PEPI score of 0 (p&amp;lt; 0.002). No differences were observed between luminal A- and B-like tumors with regard to fold-change and PEPI score. No treatment abandonment was produced during the study. Conclusions: In our cohort, NET has proven effective for tumor size and Ki67 downstaging. This results in a higher rate of conservative surgery, aids in therapeutic decision-making, provides prognostic information, and constitutes a safe and well-tolerated approach Biological changes after NET Patient and tumor characteristics Citation Format: Covadonga Marti, Laura Frias, Adolfo Loayza, Elisa Moreno, Marcos Meléndez, Jose Ignacio Sanchez-Mendez. Real World Data on Neoadjuvant Endocrine Treatment and Ki67 Assessment in ER+/HER2- Breast Cancer. Results from a Single-Institution Prospective Cohort Study [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P5-09-03.

Early breast cancer survival of black and white American women with equal diagnostic and therapeutic management

PurposeBreast cancer (BC) survival favors White versus Black Americans despite advances in screening and treatment. We hypothesized that these differences were dependent upon quality of care by analyzing long-term outcomes of 3139 early BC patients at our quaternary care center where uniform access and management of BC is provided to women irrespective of race. MethodsProspectively collected data for clinical stage I-II BC patients from our quaternary care cancer center were analyzed, focusing on disease-specific survival (DSS). Subgroup analyses included the overall cohort, triple-negative BC (TNBC), non-TNBC and HER2/neu positive patients. Multivariable analyses to evaluate associations of variables with DSS were performed for each subgroup. ResultsThe overall cohort consisted of 3139 BC patients (1159 Black, 1980 White). Black and White patients did not differ by most baseline variables. Black patients had higher rates of TNBC (18% versus 10%, p < 0.0001). Kaplan-Meier analysis of all subgroups (overall, TNBC, non-TNBC, HER2/neu positive) did not reveal DSS differences between Black and White patients. Multivariable analysis of subgroups also did not find race to be associated with DSS. ConclusionIn this large, carefully controlled, long term, single-institution prospective cohort study DSS in Black and White early BC patients with equal access to high quality care, did not differ. While BC patients with adverse molecular markers did slightly worse than those with more favorable markers, there is no observable difference between Black and White women with the same markers. These observations support the conclusion that equal access to, and quality, of BC care abolishes racial disparities in DSS.

Effectiveness of Bariatric Surgery Targeting Opioid Prescriptions (BSTOP) protocol on postoperative pain control.

BackgroundSurgical pain management is a critical component in the success of bariatric procedures. With the opioid epidemic, there have been increased efforts to decrease opioid use. In 2019, the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program developed the BSTOP protocol, a multimodal perioperative pain management regimen to minimize opioid use. The objective of this study is to evaluate the effectiveness of the BSTOP protocol on patients’ need for opioid medications during their perioperative care.MethodsThis is a single-institution prospective cohort study on patients who underwent bariatric surgery from 10/2019 to 5/2021. Data was collected on morphine equivalent dose of opioids during different stages of inpatient and outpatient care. BSTOP was implemented on 7/2020. Primary outcomes were total inpatient and outpatient opioid use as well as hospital length of hospital stay (LOS). Gabapentin was removed from the protocol between 10/20/2020 and 12/31/2020 due to side effects; it was re-implemented on 1/1/2021 due to observed spikes in opioid use during its absence.Results1264 patients who had bariatric surgery between 10/2019 and 5/2021 were included in the study, with 409 patients before (pre-BSTOP) and 855 patients after BSTOP implementation. There was a 36% reduction in total inpatient opiate use and a 57% reduction in total outpatient opiate use. LOS also significantly decreased, from 1.53 to 1.28 days. 179 patients received BSTOP without gabapentin. These patients used more opioids in the post-anesthesia care unit and on the inpatient floors compared to pre-BSTOP and BSTOP with gabapentin patients. With total inpatient and outpatient opioid use, patients on BSTOP without gabapentin used fewer opioids than those pre-BSTOP. However, those on BSTOP without gabapentin used more opioids than those with gabapentin.ConclusionThe BSTOP protocol significantly reduced inpatient and outpatient opioid use as well as LOS. Gabapentin is a crucial component of the BSTOP protocol.Supplementary InformationThe online version contains supplementary material available at 10.1007/s00464-022-09646-4.

EP08.02-127 Resistance Mechanisms to Osimertinib in Advanced EGFR-mutated NSCLC: A Single Institution Prospective Cohort Study

Osimertinib is a recommended first-line treatment for advanced EGFR-mutated (deletion in exon 19 and exon 21 L858R) and EGFR-TKI pretreated T790M-positive non-small cell lung cancer. Resistance to osimertinib inevitably developed after a period of treatment and this study aims to evaluate the mechanisms of resistance.

P64. Intradiscal injection of autologous bone marrow aspirate concentrate improves low back pain at one year

<h3>BACKGROUND CONTEXT</h3> Chronic low back pain is one of the leading causes of disability and poor quality of life in the US and worldwide. A common cause of chronic low back pain is degenerative disc disease. Current nonsurgical treatments for degenerative disc disease-associated low back pain are typically effective. However, for patients who fail these treatments, surgical fusion is often used as last line treatment. Surgical treatment is associated with higher health care expenditures and a more invasive procedure. As such, there is growing interest in the field of regenerative medicine and stem cell therapy as a less invasive treatment for low back pain. <h3>PURPOSE</h3> The purpose of this study was to investigate the effect of autologous bone marrow aspirate concentrate (BMAC) on patients with symptomatic lumbar degenereative disc disease at one year. <h3>STUDY DESIGN/SETTING</h3> Single institution prospective cohort study. <h3>PATIENT SAMPLE</h3> A total of 32 adult patients. <h3>OUTCOME MEASURES</h3> Mean ODI, EQ-5D-5L, VAS back pain, and VAS leg pain scores. <h3>METHODS</h3> A total of 32 consecutive patients over the age of 18 years diagnosed with discogenic low back pain clinically or by discography who underwent injection of autologous intradiscal BMAC at a single multi surgeon orthopedic spine center were included in this study. Active smokers and patients who had pain generators other than purely discogenic pain were excluded. For primary analysis, patients completed baseline and 1 year post-injection ODI, VAS back, VAS leg, and EQ-5D-5L questionnaires; their scores were compared over time. Preprocedural lumbar MRIs were reviewed for Modic changes and assigned a Pfirrmann grade. Thirteen postprocedural MRIs were available and reviewed using the same parameters. <h3>RESULTS</h3> Thirty-two patients (56.3% male) with a mean age of 45.9 (range 19-65) underwent BMAC injection between 1 and 6 levels completed 1 year follow up. Mean VAS back and leg scores improved from 54.0 to 30.4 (p < 0.001) and 27.9 to 13.3 (p=0.005), respectively. Mean ODI scores decreased from 33.5 to 21.1 (p < 0.001), and EQ-5D-5L scores improved from 0.69 to 0.78 (p=0.001). Using established minimum clinically important difference values, 59.4% of patients saw a clinically significant improvement in VAS back pain, 43.8% in VAS leg pain, and 56.3% in ODI scores. On pre-procedural MRIs, 62.5% of patients had a Modic score of 1 or 2 and 93.8% had a Pfirrmann grade of 3 or higher. Postprocedural MRIs were available for 13 patients, and 61.5% had no measurable change in Pfirrmann grade. Three patients worsened by one Pfirrmann grade and one improved by 1 grade. <h3>CONCLUSIONS</h3> Intradiscal injection of autologous BMAC was shown to significantly improve pain and quality of life at one year. Additionally, this study meets 88% of recently published AAOS reporting standards for studies relating to mesenchymal stem cells. The results of this study suggest that intradiscal injection of autologous BMAC has the potential to be an effective non-surgical treatment for chronic discogenic low back pain. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Prognostic Impact of Lymphatic Invasion in Patients with High-Risk Prostate Cancer after Robot-Assisted Radical Prostatectomy and Extended Lymph Node Dissection: A Single-Institution Prospective Cohort Study.

Simple SummaryThe aim of our prospective cohort study was to assess the impact of lymphatic invasion on biochemical recurrence (BCR) in patients who underwent robot-assisted radical prostatectomy (RARP) and extended lymph node dissection (eLND) for high-risk prostate cancer (PC). Of 183 patients, lymphatic invasion and lymph node metastasis were observed in 47 (26%) and 17 patients (9%), respectively, whereas BCR was observed in 48 patients (26%). The BCR rate was significantly higher in patients with lymphatic invasion than in patients without lymphatic invasion. Moreover, according to multivariable analyses, lymphatic invasion was an independent significant predictor of BCR in the overall patient group and in patients without lymph node metastasis. Evaluation of lymphatic invasion could therefore be a useful predictor of BCR in patients who have undergone RARP and eLND for high-risk PC.The prognostic impact of lymphatic invasion in patients with high-risk prostate cancer (PC) remains unclear. The aim of our single-institution prospective cohort study was to examine the impact of lymphatic invasion on biochemical recurrence (BCR) in patients with high-risk PC according to National Comprehensive Cancer Network (NCCN) criteria who underwent robot-assisted radical prostatectomy (RARP) and extended lymph node dissection (eLND). A total of 183 patients were included who underwent RARP and eLND for NCCN high-risk PC between June 2014 and August 2019. Lymphatic invasion in resected specimens was observed in 47 patients (26%), whereas lymph node metastasis was observed in 17 patients (9%). During follow-up, BCR was observed in 48 patients (26%). The BCR rate in patients with lymphatic invasion was significantly higher than that in patients without lymphatic invasion (p < 0.01). According to multivariable Cox proportional hazards regression analyses, lymphatic invasion was a significant independent predictor of BCR in the overall patient group and was independently associated with BCR, even in patients without lymph node metastasis. In conclusion, evaluation of lymphatic invasion could be useful in predicting BCR in patients undergoing RARP and eLND for high-risk PC.

Early metabolic syndrome in testicular germ cell tumors : A prospective study from India.

e17010 Background: Metabolic syndrome (MS) is a known complication in patients of testicular germ cell tumors . Early metabolic syndrome is not well-defined and literature on the same is scarce. Methods: This is a single institutional prospective cohort study of patients with testicular germ cell tumors from Jan’2020 to June 2021 with a minimum follow-up of 6 months after treatment completion. Patients were evaluated for MS as per NCEP ATP (National Cholesterol Education Program Adult Treatment Plan) III criteria and partial MS was defined if any one abnormal criteria was present. Clinicopathologic and treatment characteristics were correlated with development of MS. Results: Thirty-six (25 nonseminomatous tumor and 11 seminoma) were included with median age of 29 yrs (range: 18-44). Treatment protocol was - platinum based chemotherapy [BEP (n = 7), EP(n = 18),VIP(n = 4) ]in 81% (n = 29/36), single agent carboplatin in 8% (n = 3/36), and surveillance only in 11% (n = 4/36) patients. Incidence of complete metabolic syndrome noted in 42% (n = 15) and partial metabolic syndrome in 36% (n = 13) of patients after median follow-up of 13.2 months (range-6-22). Deranged parameters detected were - high serum triglyceride (≥150 mg/dl) in 64% (n = 23/36), low serum HDL cholesterol (&lt; 40 mg/dl) in 53% (n = 19/36), high blood pressure (≥130/85 mm of Hg) in 47% (n = 17/36), high waist circumference (&gt; 110 cm) in 6% (n = 2/36) and high fasting plasma glucose (≥5.6 mmol/L) in 22% (n = 8/36) of patients. Median weight gain was 5 Kg (range: 2-14). The median time to development of metabolic syndrome was 143 days (range: 90-461). Hypogonadism (testosterone &lt; 433ng/dl.) showed positive correlation (degree of freedom = 0.3143) and C-reactive protein showed negative correlation (degree of freedom -0.3090) with MS, respectively. Conclusions: Majority of Testicular germ cell tumor patients (n = 28, 78%) had features of early MS, irrespective of treatment modalities. Patients with hypogonadism are more likely to develop early MS. Larger prospective studies are warranted to assess the incidence of early MS in patients with testicular germ cell tumors and to formulate appropriate health intervention to mitigate its significant long-term effects on mortality and morbidity.

Risk factors for cranial irradiation-related late neurocognitive toxicity: A prospective cohort study.

2066 Background: Neurocognitive dysfunction is a common complication of cranial irradiation, occurring in up to 50% of irradiated brain tumor patients. Symptoms often severely compromise quality of life long before patients succumb to their tumor; however, risk factors are poorly understood, and consequently, prognostication and prevention have not been possible. The objective of this study was to evaluate the prognostic value of vascular risk factors for the development of irradiation-related brain injury. Methods: This single-institution prospective cohort study included patients with malignant primary brain tumors who received cranial irradiation as part of their initial tumor-directed therapy. Three putative vascular risk factors – homocysteine, total cholesterol, apoprotein E genotype (ApOE) – were measured and dichotomized (above vs. below the laboratory normal). Univariate analyses compared each risk factor with four measures of neurocognitive dysfunction: mini-mental status exam (MMSE), MRI white matter changes at 6 months (MRI), physician (Phys) assessment, and patient (Pat) assessment. Decision analysis was used to construct a prediction algorithm. Results: 80 patients were included in this analysis. Elevated homocysteine was the most powerful and consistent predictor of neurocognitive toxicity, followed by elevated triglycerides and the ApOE genotype (Table). Logistic regression revealed a highly significant (p&lt;0.01) association between homocysteine level and each of the four outcome variables. Decision tree analysis using homocysteine level (high vs. low) and ApoE genotype (yes vs. no) provided the most efficient predictive algorithm. Conclusions: Two putative vascular risk factors (homocysteine level &gt; 14 and ApOE genotype) provide moderate ability to predict post-radiation neurocognitive dysfunction using a variety of simple but clinically meaningful definitions of dysfunction. This predictive algorithm should be validated in prospective trials. If these findings are corroborated, studies examining additional risk factors as well as studies looking at risk factor mitigation will be appropriate. [Table: see text]

The Clinical Impact of Neoadjuvant Endocrine Treatment on Luminal-like Breast Cancers and Its Prognostic Significance: Results from a Single-Institution Prospective Cohort Study.

Purpose: Neoadjuvant endocrine treatment (NET) has become a useful tool for the downstaging of luminal-like breast cancers in postmenopausal patients. It enables us to increase breast- conserving surgery (BCS) rates, provides an opportunity for us to assess in vivo NET effectiveness, and allows us to study any biological changes that may act as valid biomarkers. The purpose of this study was to evaluate the safety and effectiveness of NET, and to assess the role of Ki67 proliferation rate changes as an indicator of endocrine responsiveness. Methods: From 2016 to 2020, a single-institution cohort of patients, treated with NET and further surgery, was evaluated. In patients with Ki67 ≥ 10%, a second core biopsy was performed after four weeks. Information regarding histopathological and clinical changes was gathered. Results: A total of 115 estrogen receptor-positive (ER+)/HER2-negative patients were included. The median treatment duration was 5.0 months (IQR: 2.0–6.0). The median maximum size in the surgical sample was 40% smaller than the pretreatment size measured by ultrasound (p < 0.0001). The median pretreatment Ki67 expression was 20.0% (IQR: 12.0–30.0), and was reduced to 5.0% (IQR: 1.8–10.0) after four weeks, and to 2.0% (IQR: 1.0–8.0) in the surgical sample (p < 0.0001). BCS was performed on 98 patients (85.2%). No pathological complete responses were recorded. A larger Ki67 fold change after four weeks was significantly related to a PEPI score of zero (p < 0.002). No differences were observed between luminal A- and B-like tumors, with regard to fold change and PEPI score. Conclusions: In our cohort, NET was proven to be effective for tumor size and Ki67 downstaging. This resulted in a higher rate of conservative surgery, aided in therapeutic decision making, provided prognostic information, and constituted a safe and well-tolerated approach.

Abstract P3-20-07: Uncontrolled hypertension and the development of lymphedema after breast cancer surgery

Abstract Introduction: Breast cancer is the most common type of cancer among women in the United States with more than 281,550 new cases in 2021. Definitive treatment for early/localized disease includes a combination of surgery, radiation and systemic therapy with high cure rates but significant potential morbidity. Lymphedema (LE) is the chronic swelling of tissue due to damage caused by breast cancer surgery and/or radiation therapy, occurring in approximately 25-60% of patients who undergo axillary dissection with or without radiation. LE is a morbid disease that decreases patient quality of life and has limited treatment options. Thus, identifying risk factors to prevent the development of LE is crucial. To our knowledge, uncontrolled hypertension has not been previously studied as a potential risk factor for the development of arm lymphedema after breast cancer treatment. Methods: In this single institution prospective cohort study, women were enrolled before their surgery for stage 0-III breast cancer. Baseline interviews were conducted and data including ethnic background, weight, medical comorbidities, and medications were collected. Breast cancer clinicopathologic features and treatment were also recorded. Bilateral arm measurements and blood pressure (BP) readings were taken at baseline and intervals of 3 months for up to 5 years after surgery. An increase in volume &amp;gt;5% from baseline was classified as lymphedema. The association between baseline BP and development of lymphedema was tested with univariate Cox regression model. Results: 176 women were enrolled between 1999 and 2004, of which 46% were Caucasian, 42% African American, 12% other. The average age at enrollment was 51 years. 68% were overweight or obese. 11% had Stage 0, 33% Stage I, 42% Stage II, and 14% had Stage III breast cancer. The most common type of surgery was mastectomy (52%) with remaining patients undergoing lumpectomy. Most patients underwent nodal evaluation with 55% receiving axillary node dissection, 40% receiving sentinel node biopsy or axillary node sampling, and 6% undergoing no nodal surgery. 57% of patients underwent chemotherapy and 53% received radiation therapy. At baseline, 65% of the patients reported a history of hypertension, of which approximately 50% were taking antihypertensive medications and 57% had uncontrolled blood pressure (defined as office BP ≥ 140/90). Using the 5% cutoff, 27% of patients developed lymphedema within 5 years after surgery, of which 14% occurred within the first year. Women who were obese, had mastectomy or more than 9 LNs removed were at higher risk of developing LE. Age, ethnicity and cancer stage had no association with the development of LE (Table 1). Women with uncontrolled or controlled hypertension did not have a higher risk for LE compared to those that were normotensive with hazard ratios of 0.82 (95%CI: 0.39, 1.76; p value 0.616) and 0.70 (95%CI: 0.31, 1.59; p value 0.396) respectively. Conclusion: Baseline uncontrolled or controlled hypertension does not increase the risk for the development of LE after surgery and radiation for breast cancer. Further analysis of BP control over time as another risk factor for the development of LE in this dataset is also planned. Identifying BP control as a risk factor for LE would aid in prevention efforts to decrease the development of this morbidity in breast cancer survivors. Table 1. Univariate Cox regression hazard ratios (HR) for development of lymphedema with 5% cutoffVariableEvent/nHR (95% CI)P valueAge at enrollment48/1741.00 (0.98-1.02)0.984RaceCaucasian19/81Ref.African American23/741.53 (0.83-2.82)0.171Other6/201.17 (0.47-2.93)0.741StageI13/58Ref.04/190.74 (0.24-2.29)0.605II25/741.39 (0.71-2.71)0.341III6/251.22 (0.46-3.20)0.693BMINormal9/52Ref.Underweight1/32.95 (0.37-23.43)0.306Overweight15/551.73 (0.76-3.95)0.195Obesity23/652.21 (1.02-4.78)0.044Number of Nodes Removed&amp;lt;917/87Ref.≥931/891.92 (1.06-3.47)0.031ChemotherapyNo20/76Ref.Yes28/1000.95 (0.54-1.69)0.873Radiation therapyNo24/81Ref.Yes23/940.72 (0.41-1.28)0.264Breast surgeryLumpectomy18/84Ref.Mastectomy30/911.84 (1.02-3.31)0.042Nodal surgerySNB or ALN sampling15/70Ref.No axillary surgery2/100.81 (0.19-3.57)0.786ALND31/961.55 (0.83-2.86)0.167 Citation Format: Elizabeth Weisberg, Hadeel Assad, Lydia Choi-Kim, Tammy DeMeere, Hyejeong Jang, Wei Chen, Mary Ann Kosir. Uncontrolled hypertension and the development of lymphedema after breast cancer surgery [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-20-07.

Predicting Post-Discharge Opioid Consumption After Total Hip and Knee Arthroplasty in the Opioid-Naïve Patient

BackgroundPain catastrophizing, anxiety, and depression are associated with poor outcomes after total hip (THA) and total knee (TKA) arthroplasty. The goal of this study is to determine the relationship between post-operative pain scores and opioid consumption; and the association among pre-operative measures of anxiety, depression, and pain catastrophizing and post-operative opioid consumption in patients undergoing THA and TKA. MethodsThis is a single-institution prospective cohort study of 243 opioid-naïve patients undergoing elective, primary THA (n = 123) or TKA (n = 120) for osteoarthritis. Pre-operatively, patients completed the PROMIS-29 (Patient-Reported Outcomes Measures Information System; physical function/anxiety/depression/fatigue/sleep disturbance/social activities/pain interference/pain intensity) and Pain Catastrophizing Scale. Post-operatively, patients completed a weekly survey for 12 weeks determining morphine-milligram-equivalent (MME) opioid consumption, opioid cessation, and visual analog scale pain scores. Multivariable regression models determined the association between pre-operative scores and post-operative opioid consumption. ResultsMean (±standard deviation) total opioid consumption and duration was 75.1 ± 112.0 MME and 1.7 ± 1.7 weeks in THA and 384.7 ± 473.3 MME and 4.3 ± 3.5 weeks in TKA. Visual analog scale pain scores (0-100) after opioid cessation were 28.0 ± 22.9 in THA and 30.7 ± 25.8 in TKA. Multivariable regression showed that each unit increase in PROMIS-29 fatigue T-score was associated with 8.4 hours longer opioid usage in THA (P = .008) and 15.1 hours longer in TKA (P = .036), as well as 12.7 MME additional opioids in TKA (P = .027). There were no significant associations with other PROMIS-29 domains or the Pain Catastrophizing Scale. ConclusionOpioid use duration is different for THA and TKA and may correlate with pain scores. Only pre-operative fatigue was associated with post-operative opioid consumption. These findings should inform THA and TKA post-operative pain management pathways.

Virtual postoperative visits following robotic gynecologic surgery: a study of patient satisfaction, safety, and feasibility.

Since the onset of the COVID-19 pandemic the use of telehealth has burgeoned. Numerous surgical specialties have already adopted the use of virtual postoperative visits, but there is data lacking in both robotics and gynecology. In this single-institution prospective cohort study we sought to evaluate the patient satisfaction, feasibility and safety of postoperative telehealth visits following robotic gynecologic surgery. Thirty-three patients undergoing robotic gynecologic procedures participated in a postoperative telehealth visit approximately 2 weeks following surgery, of which 27 completed a survey which assessed participant satisfaction with the telehealth visit, overall health-related quality of life following surgery, exposure to telehealth visits, and social determinants of health. The mean satisfaction score was just below ‘excellent’. Only 2 participants (6.3%) required an in-person visit. Postoperative telehealth visit satisfaction score was significantly associated only with BMI (Pearson r = 0.45, p = 0.018). These data suggest that telehealth visits following robotic gynecologic procedures appear to be safe and feasible, and are associated with a high level of patient satisfaction.Supplementary InformationThe online version contains supplementary material available at 10.1007/s11701-021-01354-w.