Sanford Health

Background: Invasive procedures used to manage intravascular masses such as vegetation from endocarditis, deep vein thrombosis, and septic emboli are associated with high rates of complications and mortality, especially in patients with several pre-existing comorbidities. A minimally invasive technique that has become more popular in recent years is the AngioVac procedure. This single-centered, retrospective study focuses on patient presenting comorbidities and indications for the procedure as well as postprocedural outcomes. Methods: A total of 33 patients who underwent an AngioVac procedure at Sanford Health between March 2014 and October 2019 was reviewed. Data were collected on pre-existing comorbidities, indication of procedure, length of stay, and postoperative outcomes. Results: We evaluated a total of 33 patients who underwent an AngioVac procedure for removal of intravascular mass. The most common indications for the procedure were endocarditis (24/33, 73%); intracardiac mass (5/33, 15%); and deep vein thrombosis or pulmonary embolism (2/33, 6%). Post-procedural blood transfusion was required in nearly half (15/33, 45%). Almost all patients (31/33, 94%) required intraoperative vasopressor use. Nearly all patients (32/33, 97%) were directed to the intensive care unit following the procedure with an average length of stay of 8 days (interquartile range: 3-13). Most common complications seen after the procedure were shock requiring vasopressors, (13/33, 39%), pleural effusion (9/33, 27%), and sepsis (4/33, 12%). Procedural success in this single-centered experience was 85% (28/33), which was defined as size reduction of the initial vegetation by >50% in the absence of severe intraoperative complications and absence of need for further valvular surgical intervention. Conclusion: For surgically high-risk patients, the AngioVac procedure may offer a less invasive option in the management of right sided endocarditis requiring vegetation debulking, intravascular thrombi or cardiac masses.

Goals To determine the attitudes and practices of gastroenterologists regarding the delivery of cancer diagnoses. Background Gastroenterologists frequently diagnose colorectal cancer. Receiving the news of a cancer diagnosis is difficult, and the delivery of the diagnosis can influence a patient’s understanding of their disease. No study to date has reported how gastroenterologists deliver cancer diagnoses to their patients. Study An anonymous questionnaire was sent online to gastroenterologists of the American College of Gastroenterology to assess views regarding the delivery of cancer diagnoses. Results Of the 280 complete responses (response rate = 1.64%), most respondents were male (n = 205, 73.21%), in practice between 0 and 9 years (n = 133, 47.50%), and at the attending/faculty level (n = 69.53%, 194). Most responded that they would disclose a cancer diagnosis to the patient themselves if they had made the discovery on endoscopy/colonoscopy (n = 255, 94.80%), with the preferred methods being an in person discussion (n = 187, 71.65%). Most respondents were not familiar with any guidelines for delivering cancer diagnoses (n = 202, 75.94%) and would be open to receiving training on cancer diagnosis delivery (n = 207, 78.11%). Conclusions Most gastroenterologists take personal responsibility in the delivery of cancer diagnoses. Many gastroenterologists receive no specific training on how to deliver this news and are unaware of any guidelines to follow that may be helpful in their practice. However, most displayed a willingness to learn these guidelines through some form of formal education. Future directions should consider the incorporation of education in cancer diagnosis delivery for gastroenterologists and gastroenterology fellows.

Fungal thyroiditis is an uncommon cause of thyroid inflammation and infection. This condition is typically observed within immunosuppressed patients, such as those with a hematologic malignancy or those receiving corticosteroids or chemo-radiation therapies. This report describes a case of a 66-year-old male with underlying high-risk myelodysplastic syndrome who presents with complaints of fever, right anterior neck pain, severe dysphagia, dysphonia, and difficulty managing upper airway secretions. A cervical computed tomography scan was performed and depicted a lowdensity area within the right thyroid lobe, infiltration of adjacent anterior fat tissue, and a retropharyngeal fluid collection. Ultrasound-guided biopsy and cytology revealed pauci-septate fungal hyphae with vascular invasion and abundant necrosis which is consistent with a diagnosis of angioinvasive fungal thyroiditis. This case demonstrates the importance of considering fungal species as a potential etiology in immunosuppressed patients with acute development of thyroiditis.

Objectives: Surgical site infections in orthopaedic trauma are a significant problem with meaningful patient and health care system-level consequences. Direct application of antibiotics to the surgical field has many potential benefits in reducing surgical site infections. However, to date, the data regarding the local administration of antibiotics have been mixed. This study reports on the variability of prophylactic vancomycin powder use in orthopaedic trauma cases across 28 centers. Methods: Intrawound topical antibiotic powder use was prospectively collected within three multicenter fracture fixation trials. Fracture location, Gustilo classification, recruiting center, and surgeon information were collected. Differences in practice patterns across recruiting center and injury characteristics were tested using chi-square statistic and logistic regression. Additional stratified analyses by recruiting center and individual surgeon were performed. Results: A total of 4941 fractures were treated, and vancomycin powder was used in 1547 patients (31%) overall. Local administration of vancomycin powder was more frequent in open fractures 38.8% (738/1901) compared with closed fractures 26.6% (809/3040) (P < 0.001). However, the severity of the open fracture type did not affect the rate at which vancomycin powder was used (P = 0.11). Vancomycin powder use varied substantially across the clinical sites (P < 0.001). At the surgeon level, 75.0% used vancomycin powder in less than one-quarter of their cases. Conclusions: Prophylactic intrawound vancomycin powder remains controversial with varied support throughout the literature. This study demonstrates wide variability in its use across institutions, fracture types, and surgeons. This study highlights the opportunity for increased practice standardization for infection prophylaxis interventions. Level of evidence: Prognostic-III.

Introduction: VLUs are associated with prolonged wound healing, high recurrence rates, and fragile periwound skin. Objective: Skin protectant use with wound dressings and multilayer compression wraps was examined. Methods: Deidentified retrospective patient data were assessed. Patients received endovenous ablation, followed by application of zinc barrier cream to periwound skin before wound dressing and multilayer compression wrap use. Dressings were changed every 7 days, and zinc barrier cream reapplied. After 3 weeks, advanced elastomeric skin protectant use was initiated due to periwound skin injury during zinc barrier cream removal. Topical wound dressing and compression wrap use was continued. Wound healing and periwound skin condition were monitored. Results: Five patients presented for care with medial ankle VLUs. Within 3 weeks of zinc barrier cream use, unwanted product buildup was noted and removal often led to epidermal stripping. Skin protectant use was changed to advanced elastomeric skin protectant. All patients showed periwound skin improvement. Epidermal stripping was not observed with advanced elastomeric skin protectant, and the product did not require removal. Conclusions: In these 5 patients, advanced elastomeric skin protectant use under wound dressings and multilayer compression wraps resulted in improved periwound skin and reduced erythema compared with zinc barrier cream use.

Background Despite new and better treatments for juvenile dermatomyositis (JDM), not all patients with moderate severity disease respond adequately to first-line therapy. Those with refractory disease remain at higher risk for disease and glucocorticoid-related complications. Biologic disease-modifying antirheumatic drugs (DMARDs) have become part of the arsenal of treatments for JDM. However, prospective comparative studies of commonly used biologics are lacking. Methods The Childhood Arthritis and Rheumatology Research Alliance (CARRA) JDM biologics workgroup met in 2019 and produced a survey assessing current treatment escalation practices for JDM, including preferences regarding use of biologic treatments. The cases and questions were developed using a consensus framework, requiring 80% agreement for consensus. The survey was completed online in 2020 by CARRA members interested in JDM. Survey results were analyzed among all respondents and according to years of experience. Chi-square or Fisher’s exact test was used to compare the distribution of responses to each survey question. Results One hundred twenty-one CARRA members responded to the survey (denominators vary for each question). Of the respondents, 88% were pediatric rheumatologists, 85% practiced in the United States, and 43% had over 10 years of experience. For a patient with moderately severe JDM refractory to methotrexate, glucocorticoids, and IVIG, approximately 80% of respondents indicated that they would initiate a biologic after failing 1–2 non-biologic DMARDs. Trials of methotrexate and mycophenolate were considered necessary by 96% and 60% of respondents, respectively, before initiating a biologic. By weighed average, rituximab was the preferred biologic over abatacept, tocilizumab, and infliximab. Over 50% of respondents would start a biologic by 4 months from diagnosis for patients with refractory moderately severe JDM. There were no notable differences in treatment practices between respondents by years of experience. Conclusion Most respondents favored starting a biologic earlier in disease course after trialing up to two conventional DMARDs, specifically including methotrexate. There was a clear preference for rituximab. However, there remains a dearth of prospective data comparing biologics in refractory JDM. These findings underscore the need for biologic consensus treatment plans (CTPs) for refractory JDM, which will ultimately facilitate comparative effectiveness studies and inform treatment practices.

Plasmablastic lymphoma (PBL) is a rare entity, commonly associated with immunosuppressed states such as human immunodeficiency virus (HIV) infection or solid organ transplant. The clinical course is characterized by high relapse rates and a poor prognosis, leading some clinicians to recommend aggressive frontline therapy. However, a specific review of limited stage (LS) PBL patients is not available to evaluate outcomes and justify treatment recommendations. We performed a retrospective review of LS PBL cases to provide insight into this rare disease. Our cohort consisted of 80 stage I or II PBL patients from 13 US academic centers. With a median follow up of 34 months (1–196), the 3‐year progression‐free survival (PFS) and overall survival (OS) of the entire cohort were 72% (95% CI 62, 83) and 79% (95% CI 70, 89), respectively. The 3‐year PFS and OS of patients treated with frontline chemotherapy alone was 65% (95% CI 50, 84) and 71% (95% CI 56, 89), respectively, compared to 85% (95% CI 72, 100) and 96% (95% CI 89, 100), respectively, in patients treated with combined frontline chemotherapy with radiation consolidation. Our data demonstrate favorable outcomes in LS PBL with no improvements in outcome from aggressive frontline treatment including Hyper‐CVAD or auto‐SCT consolidation. Multivariate regression analysis (MRA) demonstrated improved PFS for patients receiving EPOCH based frontline therapy versus CHOP (HR: 0.23; p = 0.029). Frontline chemotherapy followed by radiation consolidation versus chemotherapy alone appeared to be associated with improved relapse and survival outcomes but did not show statistical significance in MRA.

Uncultured, unmodified, autologous, adipose-derived regenerative cells (UA-ADRCs) are a safe and effective treatment option for various musculoskeletal pathologies. However, it is unknown whether the composition of the final cell suspension systematically varies with the subject’s individual age, sex, body mass index and ethnicity. UA-ADRCs were isolated from lipoaspirate from n = 232 subjects undergoing elective lipoplasty using the Transpose RT system (InGeneron, Inc.; Houston, TX, USA). The UA-ADRCs were assessed for the number of nucleated cells, cell viability and the number of viable nucleated cells per gram of adipose tissue harvested. Cells from n = 37 subjects were further characterized using four-channel flow cytometry. The present study shows, for the first time, that key characteristics of UA-ADRCs can be independent of the subject’s age, sex, BMI and ethnicity. This result has important implications for the general applicability of UA-ADRCs in regeneration of musculoskeletal tissue. Future studies must determine whether the independence of key characteristics of UA-ADRCs of the subject’s individual age, sex, BMI and ethnicity only applies to the system used in the present study, or also to others of the more than 25 different experimental methods and commercially available systems used to isolate UA-ADRCs from lipoaspirate that have been described in the literature.

Meningiomas are the most common central nervous system tumor. They are typically benign neoplasms but may produce neurological symptoms due to mass effect. Meningiomas may also extend to extradural locations; however, these account for only a small percentage of all meningiomas. Most extradural meningiomas arise in intraosseous locations, usually within the cranial bones or vertebrae. However, this is a rare case of extradural extension of an asymptomatic intracranial meningioma to the proximal humerus in the absence of any musculoskeletal symptoms. To the best of our knowledge, this presentation of an extradural intraosseous meningioma has not previously been reported in the literature. We present a case of an incidental intraosseous meningioma in a 66-year-old man. This patient was initially being screened for metastasis of stage IA1 adenocarcinoma of the lung, and a positron emission tomography (PET) scan revealed a focus of activity in the proximal diaphysis of the right humerus suspicious for malignancy. The upper extremity magnetic resonance imaging (MRI) demonstrated an indeterminate lesion. Curettage of the humeral lesion revealed an intraosseous psammomatous meningioma without evidence of metastatic lung carcinoma. Our case report aims to illustrate the importance of considering alternative metastatic sources, such as intracranial meningioma, during the investigation of an indeterminate bony lesion. This is the first case to illustrate asymptomatic intraosseous meningioma in an appendicular skeletal location, highlighting the need for thorough source investigation.

Background To best support, its membership, the IDSA Medical Education Community of Practice (Med Ed CoP) must know the spectrum of educational duties, common challenges, and needs among its clinician educators (CE). Further, benchmark data for medical education is lacking, including average time to perform duties, salary support, and other resources. Therefore, we conducted a survey to help identify opportunities for institutions and IDSA to support Infectious Disease (ID) CE. Methods We conducted an anonymous electronic mixed-methods survey of ID CE faculty in the United States. The survey link was distributed through the IDSA Med Ed CoP and Program Director discussion forums and receptions at IDWeek 2021. Results Approximately 90/552 (16%) participants completed a majority of the survey. Respondents were evenly distributed by gender and geographic region. A majority of respondents were Caucasian, aged 30 – 49 years, and at the Assistant or Associate Professor level (Table 1). Overall breakdown of allocated duties is as follows; median education full-time equivalent (FTE) was 0.25, clinical FTE=0.50, administrative FTE=0.16, and research FTE=0 (Table 1). Faculty most commonly taught medical students (95%), physician residents (92%), and fellows (88%) and held positions within ID fellowship programs (69%) and medical schools (50%, Table 2). CE's common challenges included competing responsibilities (69%), lack of medical education mentorship (51%), and inexperience in medical education publication (67%). In addition, 77% reported burnout in the past year, frequently due to an increased pandemic-related workload. CEs would like to see opportunities for IDSA grants, advocacy for salary support, and increased opportunities to publish within IDSA journals. CEs report finding reward in their educational work related to: teaching the next generation, developing relationships with learners and colleagues, and promoting others’ success. Conclusion In our study, ID CEs identified common challenges including educational work often requiring more time than allocated FTE, lack of mentors, publishing educational activities, recognition of CE work for promotion, and burnout. Additionally, ID CEs identified practical strategies in which their institutions and IDSA can offer support. Disclosures All Authors: No reported disclosures.

Background: Medication reconciliation is recognized as a critically important medication safety element and a key initiative by multiple organizations. Within our precision medicine program, accurate medication lists are essential to our ability to make specific medication recommendations based on pharmacogenetic results. Our study aimed to identify discrepancies within the patient's medication list to improve medication management via genetic factors through a pharmacy team-based approach. Methods: A dedicated team of pharmacists and trained student pharmacists conducted telephone interviews to complete medication reconciliation for individuals enrolled in our precision medicine preemptive screening program. Medication list discrepancies were tracked as well as if pharmacogenetic consults were altered by findings during the telephone interviews. Results: Medication reconciliation was completed on 465 participants who had recently received or were awaiting pharmacogenetic testing. We found similar results to previously described rates of medication list discrepancies with an average of 4.9 medication discrepancies per patient as well as greater than 90% of individuals having at least one medication discrepancy. Pharmacogenetic recommendations for 20 individuals (4.3%) required adjustment following medication reconciliation. Conclusions: This pilot program supports the value of a dedicated team for medication reconciliation and the importance of accurate medication lists to optimize precision medicine programs.

This paper describes one healthcare system’s approach to strategically deploying genetic specialists and pharmacists to support the implementation of a precision medicine program. In 2013, Sanford Health initiated the development of a healthcare system-wide precision medicine program. Here, we report the necessary staffing including the genetic counselors, genetic counseling assistants, pharmacists, and geneticists. We examined the administrative and electronic medical records data to summarize genetic referrals over time as well as the uptake and results of an enterprise-wide genetic screening test. Between 2013 and 2020, the number of genetic specialists employed at Sanford Health increased by 190%, from 10.1 full-time equivalents (FTEs) to 29.3 FTEs. Over the same period, referrals from multiple provider types to genetic services increased by 423%, from 1438 referrals to 7517 referrals. Between 2018 and 2020, 11,771 patients received a genetic screening, with 4% identified with potential monogenic medically actionable predisposition (MAP) findings and 95% identified with at least one informative pharmacogenetic result. Of the MAP-positive patients, 85% had completed a session with a genetics provider. A strategic workforce staffing and deployment allowed Sanford Health to manage a new genetic screening program, which prompted a large increase in genetic referrals. This approach can be used as a template for other healthcare systems interested in the development of a precision medicine program.

Purpose of Review The purpose of this review is to discuss the current state of knowledge regarding axial plane deformities in patellofemoral instability, indications and techniques for treatment of those deformities, and outcomes following treatment. Recent Findings There is opportunity for more information in the literature on all aspects of axial plane deformities in patellofemoral instability. This includes how to assess axial plane deformities on imaging, what is normal and what is an appropriate goal for correction, what techniques are best used depending on the deformity or concomitant pathology, and larger and more discriminating studies on outcomes. Summary Rotational deformity of both the tibia and femur is an important risk factor to consider as a cause of patellar instability. Recent research has shown that surgical correction of these deformities on either the femoral or tibial side can have a positive effect on outcome in terms of patellar instability and knee pain. Further research, however, is warranted to determine what are normal values for femoral version and tibial torsion, and at what values surgical intervention is warranted.

Purpose/Objective(s) Primary analysis (database cutoff, Oct 28, 2020) of the global KEYNOTE-799 study (NCT03631784) in patients (pts) with unresectable, locally advanced stage III NSCLC, showed that pembrolizumab (pembro; anti–PD-1) + cCRT resulted in an ORR of 70.5% in cohort A (n = 112; squamous and nonsquamous) and 70.6% in cohort B (n = 102; nonsquamous only) and grade ≥3 pneumonitis in 9 (8.0%) and 7 (6.9%) pts, respectively. We evaluated outcomes with 1 y of additional follow-up. Materials/Methods In this nonrandomized, phase 2 study, eligible pts were aged ≥18 y with previously untreated, unresectable, pathologically confirmed, stage IIIA-C NSCLC with measurable disease per RECIST v1.1. Pts in cohort A (squamous and nonsquamous) received carboplatin AUC 6 + paclitaxel 200 mg/m² and pembro 200 mg for one 3-wk cycle, followed by carboplatin AUC 2 + paclitaxel 45 mg/m² QW for 6 wks + 2 cycles of pembro 200 mg Q3W + standard thoracic radiotherapy (TRT). Pts in cohort B (nonsquamous) received 3 cycles of cisplatin 75 mg/m², pemetrexed 500 mg/m², and pembro 200 mg Q3W + standard TRT in cycles 2 and 3. All pts received 14 additional cycles of pembro 200 mg Q3W. Primary endpoints were ORR per RECIST v1.1 by blinded independent central review and the incidence of grade ≥3 pneumonitis (per NCI CTCAE v4.0). Results Of 216 pts enrolled, 112 in cohort A and 102 in cohort B received treatment. Median (range) time from first dose to database cutoff (Oct 18, 2021) was 30.2 (25.3–35.5) mo in cohort A and 25.4 (14.5–35.2) mo in cohort B. ORR (95% CI) was 71.4% (62.1%–79.6%) and 75.5% (66.0%–83.5%), respectively. Median duration of response (DOR) and OS were not reached (NR) in both cohorts; median PFS was 30.6 mo in cohort A, and NR in cohort B (Table). ORR was 66.7% in pts with PD-L1 TPS <1% and 77.3% in pts with PD-L1 TPS ≥1% in cohort A and 78.6% and 72.5%, respectively, in cohort B. ORR was similar by histology (squamous, 72.0%; nonsquamous, 74.1%). Grade ≥3 pneumonitis occurred in 16 pts (7.5%) overall; 9 pts (8.0%) in cohort A and 7 (6.9%) in cohort B. Treatment-related grade ≥3 AEs occurred in 64.3% and 51.0% of pts in cohort A and B, respectively. Data on TRT, including techniques utilized and details for organs at risk with and without pneumonitis, will be presented. Conclusion With >2 y of follow-up, pembro + cCRT continues to demonstrate robust and durable responses, regardless of PD-L1 TPS and tumor histology, promising survival outcome and manageable safety in pts with previously untreated, locally advanced stage III NSCLC.

Background Borderline resectable adenocarcinoma of the pancreas involves the major vascular structures adjacent to the pancreas and has traditionally led to poor resection rates and survival. Newer chemotherapy regimens have demonstrated improved response and resection rates. We performed a retrospective review of borderline resectable pancreatic cancers who presented to a community cancer program to determine the effect of neoadjuvant chemotherapy to improve resection rates and overall survival. Methods Records of all patients diagnosed with adenocarcinoma of the pancreas from January 1, 2015 to December 31, 2019 were reviewed to determine stage at presentation, resectablility status, treatment methods, surgical resection and survival. Borderline resectable status was determined by preoperative imaging in agreement with published criteria from the National Comprehensive Cancer Network (NCCN) Guidelines 2.2021. Data was collected and analyzed by standard t-test. This study was approved by the institution's IRB. Results During this time period 322 patients were diagnosed with ductal adenocarcinoma of the pancreas of which 151 (47%) were unresectable, 31 (10%) were locally advanced, 70 (22%) were borderline resectable, and 69 (21%) were resectable at the time of presentation. 36 (51%) of the borderline resectable patients underwent neoadjuvant chemotherapy at our institution with either FOLFIRINOX or gemcitibine/nab-Paclitaxel regimens and served as the basis for this analysis. After neoadjuvant chemotherapy 24 (68%) of the borderline-resectable patients were deemed suitable for surgical exploration. At exploration, 15 (64%) were resected with 9 (60%) achieving margin-free resection on final pathology. The overall survival of those that underwent resection was increased by 19.6 months compared to those that did not undergo surgery (35.4 versus 15.8 mos, p < 0.01). Overall morbidity after resection was 46% (33% class 1 or 2, 13% class 3) with 0% mortality at 90 days. Conclusions Use of neoadjuvant chemotherapy for borderline resectable adenocarcinoma of the pancreas results in improved resection rates and overall survival in resected patients. This management strategy for ductal adenocarcinoma of the pancreas is safe and feasible in a community-based cancer program.

Direct-to-consumer genetic testing (DTC-GT) is genetic testing initiated by a consumer through a commercial company without the direct involvement of a physician or genetics professional. DTC-GT companies have developed tests that provide information about one's ancestry, carrier status, and risk to develop certain conditions. As more consumers participate in DTC-GT, primary care providers (PCPs) are at a greater chance to encounter DTC-GT results and conversations in their practice. PCPs often do not have specialized genetics training and may not feel equipped to engage in a discussion about DTC-GT, but they are well-positioned to explore the perceived benefits and limitations of DTC-GT with their patients. Limitations of DTC-GT include risk for false positive or false negative results, risk for unintended information, and risk for privacy invasion. We provide a resource for PCPs to use when approaching the topic of DTC-GT with their patients including how to discuss motivations for pursuing and concerns about DTC-GT, as well as the limitations and implications of this testing. We hope this resource can guide fruitful conversations between PCPs and patients who are looking for support from their trusted physician while considering DTC-GT or interpreting their results.

Background: The intestinal lining renews itself in a programmed fashion that can be affected by adaptation to surgical procedures such as gastric bypass. Methods: To assess adaptive mechanisms in the human intestine after Roux-en-Y gastric bypass (RYGB), we biopsied proximal jejunum at the anastomotic site during surgery to establish a baseline and endoscopically re-biopsied the same area 6-9 months after bypass for comparison. Laser microdissection was performed on pre- and post-RYGB biopsies to isolate enterocytes for RNA sequencing. Results: RNA sequencing suggested significant decreases in gene expression associated with G2/M DNA damage checkpoint regulation of the cell cycle pathway, and significant increases in gene expression associated with the CDP-diacylglycerol biosynthesis pathway TCA cycle II pathway, and pyrimidine ribonucleotide salvage pathway after RYGB. Since Schlafen 12 (SLFN12) is reported to influence enterocytic differentiation, we stained mucosa for SLFN12 and observed increased SLFN12 immunoreactivity. We investigated SLFN12 overexpression in HIEC-6 and FHs 74 Int intestinal epithelial cells and observed similar increased expression of the following genes that were also increased after RYGB: HES2, CARD9, SLC19A2, FBXW7, STXBP4, SPARCL1, and UTS. Conclusions: Our data suggest that RYGB promotes SLFN12 protein expression, cellular mechanism and replication pathways, and genes associated with differentiation and restitution (HES2, CARD9, SLC19A2), as well as obesity-related genes (FBXW7, STXBP4, SPARCL1, UTS).