Mayo Clinic Rochester Research Articles

Abstract 4148095: The Impact of Body-Mass Index on Ventricular Tachycardia Outcomes Post-Catheter Ablation

Background: In recent years, catheter ablation has emerged as a sustainable, first-line therapy for the management of ventricular tachycardia (VT). Given the rise of the “obesity paradox” theory in atrial ablation outcomes, we sought to study the effect of BMI on patients undergoing structural VT ablation. Purpose: To assess the outcomes of VT ablation, specifically VT recurrence, in patients with elevated vs. normal BMI. Methods: Clinical characteristics and demographic data were collected for VT patients who underwent ablation at Mayo Clinic Rochester from 2012-2022. Patient BMI was classified as non-obese (<30 kg/m2), obese (30-40 kg/m2), and morbidly obese (≥40 kg/m2). The endpoint was a composite of initial monomorphic VT recurrence and repeat ablation after adjusting for age, sex, and comorbidities. Results: A total of 399 patients underwent 508 ablations. 51.4% of ablations had a BMI <30, 39.2% were between 30-40, and 9.4% were ≥40. There was a greater prevalence of hypertension and type 2 diabetes mellitus in morbidly obese patients (p <0.01). Morbidly obese individuals also had a significantly increased rate of general anesthesia during ablation and long VT cycle lengths. The Kaplan-Meier curve demonstrates no statistically significant differences in time to VT recurrence among the three BMI groups (p = 0.324). Neither morbid-obesity (aHR= 1.20; CI = 0.94-1.56, p = 0.14) nor nonmorbid-obesity (aHR = 0.92; CI = 0.76-1.10, p = 0.4), compared to non-obesity was a significant independent predictor of VT recurrence or repeat ablation on multivariate regression after adjusting for age, sex and comorbidities. Conclusion: There was no significant association between BMI groups and VT recurrence or repeat ablation, and no difference in complications. We did not find the obesity paradox to be relevant for VT ablation in our patient population. Further study would be needed with larger samples to corroborate these findings.

Self-Rated ECT Outcomes in Patients With Depression: A Naturalistic Single-Site Study.

Electroconvulsive therapy (ECT) is considered to be the most effective treatment for severe depression. This study investigated recent ECT outcomes for depression at a large tertiary center, which also provides community care. Data were obtained from Mayo Clinic Rochester patients ages 18 and older who received an acute course of ECT between August 1, 2017 and April 30, 2024. Patients were included if there was a depressive disorder diagnosis (unipolar or bipolar) and a self-rated Patient Health Questionnaire-9 (PHQ-9) within 10 days of the start and end of the acute course. Patients were excluded if the starting PHQ-9 score was less than 10. The age, sex, number of acute course treatments, stimulus electrode lead placement, and PHQ-9 scores were collected. Response (PHQ-9 improvement ≥50%) and remission (PHQ-9 < 5) rates were calculated. Linear and logistic regressions were performed to investigate predictors of response and remission. Of 1206 patients identified, 408 met final inclusion and exclusion criteria. The response rate was 80.4%, and remission rate was 52.7%. Logistic regression for response showed no significant predictors; the P value for age just missed statistical significance (odds ratio, 1.0152; 95% confidence interval, 0.9991-1.0316; P = 0.0641). Logistic regression for remission showed only a lower baseline PHQ-9 score (odds ratio, 0.9465; 95% confidence interval, 0.9049-0.9891; P = 0.0152) as a significant predictor. Our results affirmed the high efficacy of ECT in severe depression. No other established treatment for depression can report a response rate as high as 80% in a naturalistic study. This study supports the continued relevance and place of ECT for severe depression.

Exploring stakeholder perceptions about using artificial intelligence for the diagnosis of rare and atypical infections.

To evaluate critical care provider perspectives about diagnostic practices for rare and atypical infections and the potential for using artificial intelligence (AI) as a decision-support system (DSS). We conducted an anonymous web-based survey among critical care providers at Mayo Clinic Rochester between 11/25/2023 and 1/15/2024, to evaluate their experience with rare and atypical infection diagnostic processes and AI-based DSSs. We also assessed the perceived usefulness of AI-based DSSs, their potential impact on improving diagnostic practices for rare and atypical infections, and the perceived risks and benefits of their use. A total of 47/143 providers completed the survey. 38/47 agreed that there was a delay in diagnosing rare and atypical infections. Among those who agreed, limited assessment of specific patient factors and failure to consider them were the most frequently cited important contributing factors (33/38). 38/47 reported familiarity with the AI-based DSS applications available to critical care providers. Less than half (18/38) thought AI-based DSSs often provided valuable insights for patient care, but almost three quarters (34/47) thought AI-based DDSs often provided valuable insight when specifically asked about their ability to improve the diagnosis of rare and atypical infections. All respondents rated reliability as important in enhancing the perceived utility of AI-based DSSs (47/47) and almost all rated interpretability and integration into the workflow as important (45/47). The primary concern about implementing an AI-based DSS in this context was alert fatigue (44/47). Most critical care providers perceived that there are delays in diagnosing rare infections, indicating inadequate assessment and consideration of the diagnosis as the major contributors. Reliability, interpretability, workflow integration, and alert fatigue emerged as key factors impacting usability of AI-based DSS. These findings will inform the development and implementation of an AI-based diagnostic algorithm to aid in identifying rare and atypical infections.

7478 Effects of RAI on Papillary Thyroid Carcinoma with Positive Lymph Nodes

Abstract Disclosure: K.N. Rachmasari: None. A. Osman: None. D. Toro Tobon: None. S.B. Lund: None. D.J. Merlino: None. A.R. Hsu: None. M.M. Ryder: None. Background: In low-risk papillary thyroid cancer (PTC), radioactive iodine (RAI) remnant ablation has shown no impact on disease recurrence rates, which are overall low. The role of adjuvant RAI in intermediate risk disease (i.e. T3, N1) remains unproven with no randomized clinical trials to objectively assess efficacy. Thus, in our institution, its use is highly heterogenous. We retrospectively investigated the effects of adjuvant RAI on recurrence and recurrence free survival (RFS) in patients with PTC and positive cervical lymph nodes (CLN). Methods: We performed a retrospective review of patients who underwent surgery at Mayo Clinic Rochester, MN for PTC between January 2007 and December 2016. Adult patients with Tx-T3 disease according to the 8th edition of American Joint Committee on Cancer (AJCC) were identified. Patients with positive CLN (N1) and a minimum follow up of 36 months were included. Demographics, clinicopathologic characteristics, use of RAI therapy and recurrence were analyzed. Results: A total of 367 patients with PTC, Tx-3, N1, M0 were identified, of which 187 received adjuvant RAI and 180 did not. Most patients were female (63.8%), with a median age of 44 years (IQR 34-54), and a median follow up of 77 months (IQR 58.5-101.5). There were no differences in age, type of surgery, histology, multifocality, and follow up period between the RAI and no RAI subgroups. Adjuvant Thyrogen-stimulated or thyroid hormone withdrawal-based RAI was recommended at the discretion of the treating provider and/or per patient preference. Diagnostic I-123 whole body scans were performed in all patients and mostly demonstrated remnant uptake. The median dose of I-131 was 75 mCi (range 50-100). Recurrence was defined by new occurrence of disease after at least a year of absence of clinical, biochemical, and imaging evidence of disease since initial surgery. Within the entire cohort, 35 (9.5%) developed recurrence with a median time of 41 months (28-59.5). Overall, recurrence rate and RFS were not significantly different between both subgroups (p = 0.2). A subanalysis was performed in patients with clinically detectable nodal disease (n = 161), defined by abnormal cervical lymph node on preoperative neck ultrasound with or without positive fine needle aspiration biopsy. Overall recurrence rates were 17 (10.6%) in this group. There were no differences in recurrence rates and RFS in those that received RAI versus those that did not (p = 0.8). Conclusions: In patients with intermediate risk PTC defined by nodal disease and/or T3 disease, recurrences were not different between patients that did or did not receive adjuvant I-131 therapy postoperatively. A randomized, noninferiority study of adjuvant I-131 compared to no I-131 postoperatively for N1 disease is needed to determine the benefit of near total thyroidectomy and adjuvant I-131 for this cohort. Presentation: 6/3/2024

6931 Weight Trends and Predictors of Weight Gain in Breast Cancer Survivors

Abstract Disclosure: M.D. Hurtado: None. E. Tama: None. D. Hodge: None. A. Weston: None. S. Fahad: None. K. Ruddy: None. J. Olson: None. F. Coach: None. R. Carter: None. S. D'Andre: None. A. Acosta: Consulting Fee; Self; Amgen Inc. Grant Recipient; Self; Vivus USA, Novo Nordisk. C. Shufelt: None. Background: Breast cancer (BC) is the most common cancer in women. Weight gain after treatment for early-stage BC is associated with a higher risk of recurrence. Excess adiposity is also a major risk factor for cardiovascular disease, the leading cause of non-BC related death in BC survivors. This study aimed to describe weight trends in a large cohort of BC survivors and to identify predictors of weight gain after BC diagnosis. Methods: This was a retrospective study of BC survivors from the prospectively consented Mayo Clinic Breast Cancer Registry, which has enrolled &amp;gt;10,000 patients seen at least once at Mayo Clinic Rochester for a BC diagnosed within the prior year. We extracted data on weights at baseline, and years 1, 4, and 6 after BC diagnosis to generate longitudinal weight trajectory curves on the change from baseline. Weights were either reported by patients in the registry questionnaires or extracted from the electronic health records. We identified BC survivors with weight gain &amp;gt;10% from baseline weight at years 1, 4, and 6. We then conducted univariable logistic regression analyses to identify predictors of &amp;gt;10% weight gain. Variables considered included: demographics, anthropometrics, BC clinical and pathologic characteristics, BRCA 1 and 2 genetic mutation status, and treatment (surgery, neoadjuvant or adjuvant chemotherapy, and/or radiotherapy). Results: We included 4744 BC survivors, mostly white (95%) and non-Hispanic (91%), with a mean age and weight at BC diagnosis of 58 ± 13 years and 76 ± 18 kg. Most patients had clinical stage I (43%) and ER+ and PR+ BC (83% and 76%, respectively). Most patients underwent breast preserving surgery (62%), half received radiation (54%), one third (36%) received systemic chemotherapy, and two thirds (61%) received endocrine therapy. At one year after BC diagnosis the average weight change was negligible compared to baseline (mean difference -0.2 ± 8 kg), but there were small but significant average increases by years 4 and 6 (0.5 ± 9 kg, p=0.002; and 0.8 ± 10 kg, p&amp;lt;0.001; respectively). At years 1, 4, and 6, the percentage of BC survivors gaining &amp;gt;10% of their baseline weight was 10%, 15%, and 18%, respectively. Baseline characteristics associated with &amp;gt;10% weight gain at 6 years included lower baseline weight (p&amp;lt;0.001), younger age at BC diagnosis (p&amp;lt;0.001), more advanced clinical and pathologic BC stage (p=0.008), ER+ and PR+ tumor biology (p=0.02 for both), BRCA2 mutation (p&amp;lt;0.001), mastectomy (compared to breast preserving surgeries, p=0.008), the use of systemic chemotherapy treatment (p&amp;lt;0.001), and the use of endocrine therapy (p=0.03). Conclusion: While most BC survivors do not experience weight gain after survivorship, 1 out 5 may experience excessive weight gain of more than 10%. Baseline anthropometric and BC-related variables are associated with excessive weight gain and could be used as predictors of weight gain in this population. Presentation: 6/3/2024

Anesthesia Providers' Knowledge of Medication Interference with Hormonal Contraception: A Multisite Survey.

Sugammadex, aprepitant, and fosaprepitant are increasingly used perioperatively. These medications may interfere with the effectiveness of hormonal contraception. This study assessed anesthesia providers' use of sugammadex and aprepitant, their knowledge of interactions with hormonal birth control, and patient counseling practices to identify possible knowledge gaps or opportunities for practice improvement. In January 2023, an electronic survey was distributed to all anesthesia providers at Mayo Clinic sites (Mayo Clinic Rochester, Mayo Clinic Arizona, Mayo Clinic Florida, and Mayo Clinic Health System hospitals). The survey included 32 questions assessing providers' use of sugammadex and aprepitant, their knowledge of the medications' interactions with hormonal contraceptives (HC), their perceptions regarding education of these interactions during training, and their perioperative patient counseling practices. The collected data were analyzed using descriptive statistics. A total of 337 of 1092 (31%) providers completed the survey. While almost all respondents (324; 96%) knew that sugammadex may interfere with oral contraceptive effectiveness, only 158 (47%) knew about aprepitant's potential contraceptive interference. Only 176 providers (52%) knew the recommended duration for alternative contraceptive methods after use after sugammadex, and 119 providers (35%) knew the recommended duration after aprepitant exposure. Most respondents considered the interference of these perioperative drugs with HCs to be clinically relevant (sugammadex, 217, 64%; aprepitant, 191, 58%). Despite the common belief that the decision between these medications and alternatives should be shared between provider and patient, most providers reported rarely engaging in such shared decision-making (SDM) in practice. Most providers recognized the need for preoperative discussions on sugammadex (280, 83%) and aprepitant (257, 76%), yet 184 providers (73%) never or rarely discussed contraception use before surgery for aprepitant, and 135 (36%) never or rarely did so for sugammadex. Lastly, many providers believed that the interference between sugammadex, aprepitant, and HC was poorly taught during training. The results of this study highlight the need for increased education and awareness among anesthesia providers regarding drug interactions with HCs during the perioperative period. To facilitate SDM, it is imperative that providers discuss alternative medications and the potential need for additional contraception methods after drug administration and communicate the risks with patients preoperatively to enable informed and SDM. The patient's preferences should be accounted for, especially if they are unwilling or unable to use an alternative contraceptive for 7 to 30 days, thereby avoiding the complexities and burdens of altering birth control methods.

Management and Long-Term Outcomes of Patients With Hepatic Epithelioid Hemangioendothelioma.

Hepatic epithelioid hemangioendothelioma (HEHE) is an uncommon vascular neoplasm characterized by variable clinical behavior. Our aim was to describe the therapeutic approach for HEHE at diagnosis and define clinicopathological characteristics associated with tumor progression and long-term survival. This is a retrospective study that includes patients with HEHE who received treatment at Mayo Clinic Rochester between 1984 and 2023. Eighty patients were included in the study (median age: 44 years; 62.5% female), 24 underwent liver transplantation, 26 underwent liver resection, and 30 were managed medically. The 3-year overall survival rates were 86.7%, 80.9%, and 51.1%, respectively. Notably, 26 patients had extrahepatic metastases at the time of diagnosis, four (16.7%) in the transplantation group, four (15.4%) in the resection group, and 18 (69.2%) in the nonsurgical group. On multivariable modeling, bone metastasis was independently associated with long-term mortality (HR 6.3, p < 0.001) while lung metastasis and surgical intervention were not associated with long-term mortality (HR 0.8, p = 0.8; HR 1.1, p = 0.9, respectively). Bone metastasis emerged as a strong predictor of poor survival. Hence, aggressive surgical intervention may not be advantageous in patients with skeletal metastases but can still be offered for those with other extrahepatic metastases.

Clinical Implications of Ultrasound-Based Morphology in Choroidal Melanoma

ObjectiveTo describe the frequency of different B-scan morphologies and their association with clinical features and outcomes. DesignCohort study of patients enrolled in the Prospective Ocular Tumor Study from January 2000 to January 2024 initially seen at Mayo Clinic Rochester. ParticipantsConsecutive inclusion of patients with posterior uveal melanoma. MethodsB-scan ultrasounds were performed by an experienced technician and treatment modalities were implemented by the attending oncologist. Main outcomes and measuresTumors were classified by shape as observed on B-scan. Enucleation-, metastasis, -and overall survival (EFS, MTS, and OS) rates were analyzed using Cox-regression models and Kaplan-Meier curves. ResultsAmong 1021 cases of uveal melanoma, 739 (72.4%) were dome-shaped, 119 (11.7%) mushroom-shaped, 85 (8.3%) multilobulated, 77 (7.5%) minimally elevated, and 1 (0.1%) diffuse. The median follow-up duration after presentation was 37 months (3-324). The macula was more commonly involved in minimally elevated tumors compared to the other groups (63.6% vs. 13.8%, p<0.001). These tumors also exhibited a larger proportion of high internal reflectivity (13% vs. 2.3%, p<0.001). The multilobulated group exhibited a significantly larger diameter at baseline (median 15 mm, IQR 6.1-30), whereas the mushroom-shaped group had greater thickness (median 7.9 mm, IQR 1.3 - 17.3) compared to the other groups (p<0.001). EFS at 36 months was lower for mushroom-shaped [60.1% (95% CI, 47.7-70.3)] and multilobulated tumors [71.1% (95% CI, 55.7-82.7)]. At 36 months, multilobulated tumors had lower MFS [68.2% (95%, CI 55-78.2)] and OS [73.9% (95%, CI 59.9-83.64)]. On multivariate analysis adjusted for tumor thickness and diameter, multilobulated melanomas had a higher risk of metastasis (HR 2.08, p=0.003) and death (HR 2.38, p<0.001). ConclusionChoroidal melanoma configuration by B-scan can vary from minimally elevated to dome-shaped to mushroom-shaped or multilobulated. Independent of presenting tumor size, multilobulated morphology was identified as a predictor for metastasis and death. Multilobulated melanomas, identified by a readily available tool such as ultrasonography, warrant a vigilant approach and close monitoring due to a potential association with poor prognosis.

Filling Gaps in Practice Leadership: Succession Planning for Clinical Nurse Specialist Positions.

To create a succession plan for clinical nurse specialist positions across multiple clinical settings. Mayo Clinic (Rochester, Minnesota) had multiple clinical nurse specialist position vacancies. However, standard recruitment methods and a collaboration between human resources and nursing managers to expand the applicant pool yielded few applicants. A work group was subsequently commissioned to identify innovative ways to fill the vacant clinical nurse specialist positions. Guiding principles for hiring and implementing the role were developed. During the 4-year project period (2016 through 2019), the time to fill positions decreased from 174 days to 83 days. Nurse managers and clinical nurse specialists reported an increased number of registered nurses seeking information about the profession. Twenty-eight clinical nurse specialist interns, titled clinical resource nurses, were hired, and 14 completed their graduate degree, obtained state licensure, and transitioned to clinical nurse specialist roles. Twelve clinical resource nurses were on schedule to transition to clinical nurse specialist positions, and 2 left their positions. A succession plan that used clinical nurse specialists to mentor clinical resource nurses to fill gaps in practice priorities while completing graduate education was a successful strategy to fill vacant clinical nurse specialist positions.

Comparative Outcomes of Robotic Versus Open Proctectomy for Rectal Cancer at High Risk of Positive Circumferential Resection Margin.

Concerns persist regarding the effectiveness of robotic proctectomy when compared with open proctectomy for locally advanced rectal cancer with a high risk of circumferential resection margin involvement. Comparison of surrogate cancer outcomes following robotic versus open proctectomy in this subpopulation. Retrospective cohort study. Three academic hospitals (Mayo Clinic Arizona, Florida, and Rochester) through the Mayo Data Explorer platform. Patients at high risk of circumferential resection margin involvement were selected based on the magnetic resonance imaging-based definition from Mercury I and II trials. Rate of pathologic circumferential resection margin involvement (≤1 mm), mesorectal grading, rate of distal margin involvement. Out of 413 patients, 125 (30%) underwent open and 288 (70%) robotic proctectomy. Open proctectomy was significantly associated with a greater proportion of cT4 tumors (39.3% vs. 24.8%, p = 0.021), multivisceral/concomitant resections (40.8% vs. 18.4%, p < 0.001) and less frequent total neoadjuvant therapy use (17.1% vs. 47.1%, p = 0.001). Robotic proctectomy was less commonly associated with pathologic circumferential resection margin involvement (7.3% vs. 17.6%, p = 0.002), including after adjustment for cT stage, neoadjuvant therapy, and multivisceral resection (OR 0.326, 95% CI, 0.157-0.670, p = 0.002). Propensity score-matching on 66 patients per group and related multivariable analysis no longer indicated any reduction of circumferential positive margin rate associated with robotic surgery (p = 0.86 and p = 0.18). Mesorectal grading was comparable (incomplete mesorectum in 6% RP patients vs. 11.8% OP patients, p = 0.327). All cases had negative distal resection margins. Retrospective design. In patients with locally advanced rectal cancer at high risk of circumferential resection margin involvement, robotic proctectomy is an effective approach and could be pursued when technically possible as an alternative to open proctectomy. See Video Abstract.

Predicting Choroidal Nevus Transformation to Melanoma Using Machine Learning

PurposeTo develop and validate machine learning (ML) models to predict choroidal nevus transformation to melanoma based on multimodal imaging at initial presentation. DesignRetrospective multicenter study. ParticipantsPatients diagnosed with choroidal nevus on the Ocular Oncology Service at Wills Eye Hospital (2007-2017) or Mayo Clinic Rochester (2015-2023). MethodsMultimodal imaging was obtained, including fundus photography, fundus autofluorescence, spectral domain OCT, and B-scan ultrasonography. ML models were created (XGBoost, LGBM, Random Forest, Extra Tree) and optimized for area under receiver operating curve (AUROC). The Wills Eye Hospital cohort was utilized for training and testing (80% training-20% testing) with 5-fold cross validation. The Mayo Clinic cohort provided external validation. Model performance was characterized by AUROC and area under the precision recall curve (AUPRC). Models were interrogated using SHapley Additive exPlanations (SHAP) to identify the features most predictive of conversion from nevus to melanoma. Differences in AUROC and AUPRC between models were tested using 10,000 bootstrap samples with replacement and results. Main Outcome MeasuresAUROC and AUPRC for each ML model. ResultsThere were 2,870 nevi included in the study, with conversion to melanoma confirmed in 128 cases. Simple AI Nevus Transformation System (SAINTS; XGBoost) was the top performing model in the test cohort [pooled AUROC 0.864 (95% confidence interval (CI): 0.864-0.865), pooled AUPRC 0.244 (0.243-0.246)] and in the external validation cohort [pooled AUROC 0.931 (95% CI: 0.930-0.931), pooled AUPRC 0.533 (0.531-0.535)]. Other models also had good discriminative performance: LGBM (test set pooled AUROC 0.831, validation set pooled AUROC 0.815), Random Forest (test set pooled AUROC 0.812, validation set pooled AUROC 0.866), and Extra Tree (test set pooled AUROC 0.826, validation set pooled AUROC 0.915). A model including only nevi with at least 5 years of follow up demonstrated the best performance in AUPRC (test: pooled 0.592 (95% CI: 0.590-0.594); validation: pooled 0.656 (95% CI: 0.655-0.657)). The top five features in SAINTS by SHAP values were: tumor thickness, largest tumor basal diameter, tumor shape, distance to optic nerve, and subretinal fluid extent. ConclusionsWe demonstrate accuracy and generalizability of a ML model for predicting choroidal nevus transformation to melanoma based on multimodal imaging.

Remote patient monitoring for early detection of immune checkpoint inhibitor therapy-related pneumonitis in high-risk patients: A pilot-feasibility study.

e13806 Background: Immune checkpoint inhibitor therapy-related (ICI) pneumonitis poses a significant challenge for patients with cancer. It is associated with increased clinical morbidity and mortality, often resulting in prolonged hospital stays and delays and/or discontinuation of cancer-directed treatment. Early detection and prompt treatment of ICI pneumonitis is critical to improve patient outcomes. Therefore, our institution implemented a remote patient monitoring (RPM) program leveraging in-home, electronic health record-integrated technology and virtual centralized nursing to monitor vital signs and patient symptoms in “high-risk” patients treated with immunotherapy. Methods: Patients receiving immunotherapy deemed to be “high-risk” for ICI pneumonitis seen at Mayo Clinic Rochester, Minnesota were offered enrollment in the RPM program beginning in June 2023. High-risk patients included those with pre-existing lung disease (chronic obstructive pulmonary disease, interstitial lung disease); those with a history of resolved ICI pneumonitis being rechallenged with immunotherapy; and those with grade 1 ICI pneumonitis continuing immunotherapy. Eligible patients who agreed to participate in the program were provided a kit consisting of RPM technology and electronic symptom questionnaires. The kit included an armband for continuous vital sign monitoring, a blood pressure monitor, a scale to measure weight, and a pre-connected cellular-enabled tablet for questionnaire answering. RPM data utilized real-time electronic health system integration and predetermined parameters to alert RPM nurses. Pre-specified escalation care pathways were then used to respond and escalate care, as necessary. The primary outcome of this pilot study was to assess the feasibility of implementing an RPM program in this patient population with a secondary outcome to determine the ability to detect ICI pneumonitis before significant clinical symptoms. Results: Sixteen patients were enrolled of whom 5 declined participation (2 due to inconvenience and 3 for unclear reasons) resulting in 11 patients who underwent monitoring. Five patients graduated monitoring without detection of ICI pneumonitis within a 4-month timeframe. Six patients are currently undergoing RPM. 372 alerts occurred of which 8 (2%) were escalated to physician review. These alerts included elevated heart rate in 4, shortness of breath in 3, and elevated blood pressure in 1. One patient was triaged to an emergency department and diagnosed with grade 2 ICI pneumonitis. Conclusions: We show that RPM in patients who are at high-risk for developing ICI pneumonitis can be effectively integrated into a care model and monitor pneumonitis related symptoms. Further studies are needed to prove whether RPM is beneficial in this population including other ICI toxicities.

Metformin and cytokine release syndrome after immune effector cell therapy.

e14535 Background: Cytokine release syndrome (CRS) is the most common complication of chimeric antigen receptor T cells (CAR-T) for hematologic malignancies. We hypothesized that patients undergoing CAR-T therapy who are on metformin will experience a lower incidence or severity of CRS than patients not on this medication. Methods: We evaluated all patients treated with CAR-T at Mayo Clinic Rochester between 1/1/2018 and 1/31/2023, and abstracted relevant clinical and laboratory characteristics to determine the incidence and severity of CRS, PFS as well as OS in patients who were, or were not, on metformin before and during CAR-T therapy for Type 2 diabetes mellitus. We used the Chi-Square test, Mann-Whitney test and the Kaplan-Meier method to analyze data. Results: In the 5-year interval under consideration 237 patients received CAR-T, 168 for non-Hodgkin lymphoma (NHL), and 69 for multiple myeloma (MM). 23 patients (15 NHL and 8 MM) were on metformin at the time of CAR-T. 15 patient developed CRS while on metformin and 175 patients not on metformin (p=0.05). Grade 3 or 4 CRS incidence was 4% in both groups (p=0.41). Of the 153 patients with NHL not on metformin, 121 developed any grade of CRS, while 10 of 15 patients on metformin developed CRS (p=0.268). 4 NHL patients developed CRS Grade ≥3 or higher, while 0 of 15 on metformin developed Grade ≥3 CRS (p=0.237). For the MM patients, the incidence of CRS was 49 patients not on metformin and 5 patients on metformin (p&lt;0.001). 3 MM patients developed CRS Grade ≥3 or higher, while 0 of 8 on metformin developed Grade ≥3 CRS (p=0.346). 12 of 15 patients on metformin with NHL achieved CR compared to 92 of 153 patients not on metformin (p=0.1305). 3 of 8 patients with MM on metformin compared to 24 of 61 patients with MM not on metformin achieved CR or better post CAR-T (p=0.92). Tocilizumab was used in 40% of patients on metformin but in 66% of patients not on metformin (p=0.0016). In NHL patients, PFS from CAR-T infusion was not reached (range: 6.3 to NR) for patients on metformin versus 9.9 months (range: 6.3–19.5) in patients not on metformin (p = 0.3332). In the MM patients, progression-free survival (PFS) from CAR-T infusion was 8.4 months (95% CI: 7.9–not reached [NR]) for patients on metformin and 22.6 months (13.7–NR) for those not on metformin (p = 0.07). Median OS for NHL patients on metformin was not reached (9.766–NR) versus 32.6 months (18.6–NR) for patients not on metformin (p = 0.7022). Median OS was 17 months (95% CI: 8.3 to NR) for patients with MM on metformin vs NR (95% CI: 9.4 to NR) for patients not on metformin (p = 0.2559). Conclusions: In this retrospective study, the co-administration of metformin during CAR-T cell therapy for NHL and MM appears to be associated with a numerically reduced incidence of CRS. The effect appears to be particularly marked in patients with multiple myeloma. Metformin therapy did not seem to affect the response to CAR-T therapy in either NHL or MM.

Real world outcome of patients with multiple myeloma who received bispecific antibodies after CAR-T therapy.

7520 Background: There are 2 CAR-T products and 3 bispecific antibodies (BsAbs) that are FDA-approved for patients (pts) with relapsed, refractory multiple myeloma (MM). Clinical trials experience to date suggests that clinical response of BsAb is less impacted after CAR-T therapy. We examined the outcome of pts who received BsAb in standard-of-care (SOC) practice at Mayo Clinic Rochester. Methods: Retrospective analysis of MM patients who received FDA-approved BsAb at Mayo Clinic, Rochester between 12/2022- 1/2024. IMWG criteria was used for clinical response. Results: Sixty-two patients received BsAbs: 77% (48/62) received teclistamab, and 23% (14/62) received talquetamab. Median age was 62 years (range: 33-81), 60% (37/62) were males, and 45% (28/62) received prior CAR-T. Patients who had prior CAR-T therapy had more prior lines of therapy compared to those who did not. Overall, ORR to teclistamab was 61%, which is comparable to previous studies and other real-world reports. ORR and ≥CR rates were comparable between patients with and without prior CAR-T (Table). Of the 28 pts who received CAR-T before BsAbs, 61% (17/28) received idecabtagene vicleucel, 10% (3/28) were ciltacabtagene autoleucel, and 29% (8/28) on clinical trial. We then compared outcome of BsAb between pts who had relapsed from CAR-T within 1 year (n=21, median PFS: 8.84 months (range, 1.12, 10.84)) or after 1 year (n=7, median PFS: 16.62 months (range, 13.30, 36.20)). At the time of BsAb infusion, pts with who relapsed &lt; 1 year vs ≥1 year post CAR-T had comparable blood counts, ALC, M-protein and involved FLC levels, CRP, ferritin and LDH. BsAb CR/sCR rate was significantly higher in pts with disease relapse ≥1 year compared to &lt;1 year post CAR-T (57% vs 14%, p=0.02). Conclusions: Irrespective of prior CAR-T exposure, BsAb have clinical activity in SOC practice in pts with MM. Our preliminary data suggest that responses to BsAbs are better in pts with late compared to early relapse post CAR-T. Longer follow-up is needed to understand the duration of response. Larger, multi-center studies with longer follow-up will help identify factors that impact BsAb response post CAR-T.[Table: see text]

Factors associated with infectious diseases fellowship academic success

ABSTRACT Background A multitude of factors are considered in an infectious disease (ID) training program’s meticulous selection process of ID fellows but their correlation to pre and in-fellowship academic success as well as post-fellowship academic success and short-term outcomes is poorly understood. Our goal was to investigate factors associated with subsequent academic success in fellowship as well as post-fellowship short-term outcomes. Methods In 2022, we retrospectively analyzed deidentified academic records from 39 graduates of the Mayo Clinic Rochester ID Fellowship Program (1 July 2013- 30 June 2022). Data abstracted included demographics, degrees, honor society membership, visa/citizenship status, medical school, residency training program, United States Medical Licensure Exam (USMLE) scores, letters of recommendation, in-training examination (ITE) scores, fellowship track, academic rank, career choice, number of honors, awards, and abstracts/publications prior to fellowship, during training, and within 2 years of graduation. Results Younger fellows had higher USMLE step 1 scores, pre and in-fellowship scholarly productivity, and higher ITE performance. Female fellows had significantly higher USMLE step 3 scores. Prior research experience translated to greater in-fellowship scholarly productivity. Higher USMLE scores were associated with higher ID ITE performance during multiple years of fellowship, but USMLE step 2 clinical knowledge and 3 scores were associated with higher pre and in-fellowship scholarly productivity and receiving an award during fellowship. The USMLE step 1 score did not correlate with fellowship performance beyond year 1 and 2 ITE scores. Conclusions Multiple aspects of a prospective fellow’s application must be considered as part of a holistic review process for fellowship selection. USMLE step 2 CK and 3 scores may predict fellowship performance across multiple domains.

Abstract PO2-09-04: Changes in an artificial intelligence model score for breast cancer detection (Transpara) with tamoxifen and aromatase inhibitor treatment

Abstract Artificial intelligence (AI) models applied to mammography have been shown to improve breast cancer (BC) detection and risk estimation. The Transpara AI detection system has been associated with short and longer-term risk of invasive BC. Whether Transpara can identify changes in the breast associated with tamoxifen (TAM) and aromatase inhibitor (AIs) treatment is unknown. We compare changes in the Transpara malignancy score in the unaffected breast of BC cases using TAM or AIs to those of untreated women without cancer. Cases and controls were sampled from the Mayo Clinic Rochester Breast Screening Practice. Eligible cases were women with breast cancer treated with TAM and/or AIs for at least 8 months who had full field digital (FFDM) mammograms within two years prior to start of treatment (pretreatment mammogram). Controls did not have BC, were not using TAM, AIs, or postmenopausal hormones, and had at least two FFDM screening mammograms. Transpara scores (1-10) were calculated for the contralateral breast in cases and a randomly selected side for controls. Two controls were matched to each case on menopausal status at both mammograms, time between mammograms (&amp;lt; 6 months) and baseline Transpara score (±2 units). Conditional logistic regression was used to assess the association of treatment (case (TAM/AIs) vs. control) with change in Transpara score between the pretreatment mammogram and the mammogram taken closest to 13 months later. Change was classified as having a decrease in Transpara score between the two mammograms vs. no change or an increase. Models were adjusted for age and Transpara score at pretreatment mammogram, and time between the two mammograms. We performed analyses on all women combined and stratified by time on treatment, menopausal status, and treatment type (TAM vs. AIs). A total of 134 cases were identified, with 53 on TAM (21 premenopausal and 32 postmenopausal) and 81 on AIs (postmenopausal); 268 controls were matched to the cases. Characteristics of the study population are summarized (Table). Most case mammograms were obtained within six months prior to treatment start [median 2.63 months (interquartile range (IQR), 1.62, 5.72)] and median time on TAM/AIs was 10.9 months (IQR, 8.03, 16.6) at time of second mammogram. The median absolute change in Transpara score between the two mammograms was similar in cases [0 (IQR, -2, 1)] vs. controls [0 (IQR, -1.25, 1)]; 40.3% of cases and 39.2% of controls had any decrease. Conditional logistic models found no evidence for an association between TAM/AIs and decrease in Transpara score [odds ratio (OR) = 1.07; 95% confidence interval (CI), 0.65, 1.78]. When stratified by median time on treatment (10.9 months), there was suggestion of a stronger association for those on treatment for a longer duration (OR = 1.21; 95% CI, 0.61, 2.40 for &amp;gt;10.9 months vs. OR = 0.96; 95% CI, 0.43, 2.13 for &amp;lt; 10.9 months) but these results were not statistically significant. Similarly, odds ratios were stronger in postmenopausal (OR = 1.18; 95% CI, 0.67, 2.07) compared to premenopausal (OR = 0.91; 95% CI, 0.24, 3.45) women, and for AIs (OR = 1.21, 95% CI, 0.64, 2.29) vs. TAM (OR = 0.93; 95% CI, 0.39, 2.22) but none of these results reached statistical significance. In summary, we found no association between treatment with TAM/AIs and change in Transpara score. However, our study had limited power. Also, longer time on treatment as well as investigation of AI-based scores trained directly to assess BC risk may be necessary to identify relevant changes. Citation Format: Yvonne Wang, Christopher Scott, Matthew Jensen, Dan Hursh, Kathleen Brandt, Aaron Norman, Fang Fang Wu, Stacey Winham, Karla Kerlikowske, Celine Vachon. Changes in an artificial intelligence model score for breast cancer detection (Transpara) with tamoxifen and aromatase inhibitor treatment [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-09-04.

Prediction of Postoperative Urinary Tract Infection Following Benign Gynecologic Surgery.

The objective was to develop a prediction model for urinary tract infection (UTI) after pelvic surgery. We utilized data from three tertiary care centers of women undergoing pelvic surgery. The primary outcome was a UTI within 8weeks of surgery. Additional variables collected included procedural data, severity of prolapse, use of mesh, anti-incontinence surgery, EBL, diabetes, steroid use, estrogen use, postoperative catheter use, PVR, history of recurrent UTI, operative time, comorbidities, and postoperative morbidity including venous thromboembolism, surgical site infection. Two datasets were used for internal validation, whereas a third dataset was used for external validation. Algorithms that tested included the following: multivariable logistic regression, decision trees (DTs), naive Bayes (NB), random forest (RF), gradient boosting (GB), and multilayer perceptron (MP). For the training dataset, containing both University of British Columbia and Mayo Clinic Rochester data, there were 1,657 patients, with 172 (10.4%) UTIs; whereas for the University of Calgary external validation data, there were a total of 392 patients with a UTI rate of 16.1% (n = 63). All models performed well; however, the GB, DT, and RF models all had an area under the curve (AUC) > 0.97. With external validation the model retained high discriminatory ability, DT: AUC = 0.88, RF: AUC = 0.88, and GB: AUC = 0.90. A model with high discriminatory ability can predict UTI within 8weeks of pelvic surgery. Future studies should focus on prospective validation and application of randomized trial models to test the utility of this model in the prevention of postoperative UTI.

Electrical storm after left ventricular assist device (LVAD) implantation.

Ventricular tachycardia storm or electrical storm (ES) is a common complication following left ventricular assist device (LVAD) implantation. The factors contributing to ES and outcomes are less studied. The study aimed to determine the factors associated with ES and the probability of survival in patients undergoing LVAD in three tertiary centers over a span of 15 years. We performed a retrospective cohort study on all patients who underwent LVAD implantation at the Mayo Clinic (Rochester, Phoenix, and Jacksonville) from January 1, 2006to December 31, 2020. ES was defined as ≥3 episodes of sustained ventricular tachycardia over a period of 24 h with no identifiable reversible cause. Detailed chart reviews of the electronic health records within the Mayo Clinic and outside medical records were performed. A total of 883 patients who underwent LVAD implantation were included in our study. ES occurred in 7% (n = 61) of patients with a median of 13 days (interquartile range [IQR]: 5-297 days) following surgery. We found 57% of patients (n = 35) developed ES within 30 days, while 43% (n = 26) patients developed ES at a median of 545 (IQR 152-1032) days after surgery. Following ES, 26% of patients died within 1 year. Patients with ES had a significant association with a history of ventricular arrhythmias and implantable cardioverter defibrillator(ICD) shocks before the procedure. ES was significantly associated with reduced survival compared to patients without ES(hazards ratio [HR]: 1.92, 95% CI: 1.39-2.64, p < .001). Following LVAD implantation, the rate of ES was 7% with majority of ES occurring within 30 days of LVAD. Risk factors for ES included pre-implant history of ventricular arrhythmias and ICD shock. ES was significantly associated with reduced survival compared to patients without ES.

A large language model-based generative natural language processing framework fine-tuned on clinical notes accurately extracts headache frequency from electronic health records.

To develop a natural language processing (NLP) algorithm that can accurately extract headache frequency from free-text clinical notes. Headache frequency, defined as the number of days with any headache in a month (or 4 weeks), remains a key parameter in the evaluation of treatment response to migraine preventive medications. However, due to the variations and inconsistencies in documentation by clinicians, significant challenges exist to accurately extract headache frequency from the electronic health record (EHR) by traditional NLP algorithms. This was a retrospective cross-sectional study with patients identified from two tertiary headache referral centers, Mayo Clinic Arizona and Mayo Clinic Rochester. All neurology consultation notes written by 15 specialized clinicians (11 headache specialists and 4 nurse practitioners) between 2012 and 2022 were extracted and 1915 notes were used for model fine-tuning (90%) and testing (10%). We employed four different NLP frameworks: (1) ClinicalBERT (Bidirectional Encoder Representations from Transformers) regression model, (2) Generative Pre-Trained Transformer-2 (GPT-2) Question Answering (QA) model zero-shot, (3) GPT-2 QA model few-shot training fine-tuned on clinical notes, and (4) GPT-2 generative model few-shot training fine-tuned on clinical notes to generate the answer by considering the context of included text. The mean (standard deviation) headache frequency of our training and testing datasets were 13.4 (10.9) and 14.4 (11.2), respectively. The GPT-2 generative model was the best-performing model with an accuracy of 0.92 (0.91, 0.93, 95% confidence interval [CI]) and R2 score of 0.89 (0.87, 0.90, 95% CI), and all GPT-2-based models outperformed the ClinicalBERT model in terms of exact matching accuracy. Although the ClinicalBERT regression model had the lowest accuracy of 0.27 (0.26, 0.28), it demonstrated a high R2 score of 0.88 (0.85, 0.89), suggesting the ClinicalBERT model can reasonably predict the headache frequency within a range of ≤ ± 3 days, and the R2 score was higher than the GPT-2 QA zero-shot model or GPT-2 QA model few-shot training fine-tuned model. We developed a robust information extraction model based on a state-of-the-art large language model, a GPT-2 generative model that can extract headache frequency from EHR free-text clinical notes with high accuracy and R2 score. It overcame several challenges related to different ways clinicians document headache frequency that were not easily achieved by traditional NLP models. We also showed that GPT-2-based frameworks outperformed ClinicalBERT in terms of accuracy in extracting headache frequency from clinical notes. To facilitate research in the field, we released the GPT-2 generative model and inference code with open-source license of community use in GitHub. Additional fine-tuning of the algorithm might be required when applied to different health-care systems for various clinical use cases.

Use of crushed tranexamic acid tablets in water for paediatric patients with bleeding disorders.

Ε-Aminocaproic acid oral solution (EACA OS) is the only commercially available antifibrinolytic for patients who cannot swallow tablets. Insurance denials and high costs remain barriers to its use. To determine the safety and efficacy of crushed tranexamic acid tablets in water (cTXAw) for children with bleeding disorders. We retrospectively reviewed records of children (<10 years) with bleeding disorders who received cTXAw or EACA OS from 1 December 2018, through 31 July 2022, at Mayo Clinic (Rochester, Minnesota). Bleeding outcomes were defined according to ISTH criteria. Thirty-two patients were included (median age, 3 years; male, n=23). Diagnoses were VWD (n=17), haemophilia (n=5), FVII deficiency (n=3), inherited platelet disorder (n=4), ITP (n=2), and combined FV and FVII deficiencies (n=1). Thirty-two courses of cTXAw (monotherapy 24/32; mean duration 6 days) and fifteen courses of EACA (monotherapy 12/15; mean duration 5 days) were administered. No surgical procedures (n=28) were complicated by bleeding. Of the 19 bleeding events, 16 had effective haemostasis, two had no reported outcome, and one had no response. cTXAw and EACA were equally effective in preventing and treating bleeding (p value>.1). No patients had adverse effects. Eight of 19 patients (42%) who were initially prescribed EACA OS did not receive it because of cost or insurance denial. The estimated average wholesale price of one treatment was $94 for cTXAw and $905 for EACA OS. CTXAw appears to be an effective, safe, and low-cost alternative option to EACA OS for young children with bleeding disorders.