Abstract Objective To assess the performance and cost implications of contrast-enhanced mammography-guided biopsy (CEM Bx). Methods This is a prospective study from May 5, 2021, to April 18, 2022, across 2 U.S. academic centers, evaluating technical success, patient/radiologist feedback, and operational factors of CEM Bx. Inclusion criteria included that patients be 40 years or older and recommended for biopsy with suspicious findings on contrast-enhanced mammography (CEM). Descriptive statistics are reported for clinical outcomes, length of procedure, and user and participant feedback. An estimate of cost was made by comparing general Medicare costs that are being billed for CEM Bx and post-clip mammogram ($475.48) to the Medicare costs of MRI-guided biopsy (MRI Bx) and post-clip placement mammogram ($845.94). Results Eighty-two participants enrolled. Twenty-two were excluded at the time of CEM Bx (22/82, 27%). Sixty participants were included (mean age 57 years, range 33 to 81 years) with 63 suspicious CEM lesions. The malignancy rate was 22% (14/63). A technical success rate of 100% was achieved. Average CEM Bx time was 29% to 33% the average reported MRI-guided breast biopsy times (CEM Bx = 11 minutes; MRI Bx = 33 to 38 minutes), indicating operational efficiencies. A positive opinion of CEM Bx was reported by 78% of radiologists, 93% of technologists, and 98% of patients. The estimated cost for each CEM Bx was ~ 45% lower than MRI Bx. Conclusion CEM Bx demonstrates high success rates and satisfaction scores. CEM Bx resulted in shorter procedure times, enhanced operational efficiency, and ~45% reduction in costs compared with MRI Bx. As advancements continue, we anticipate CEM Bx will offer a cost-efficient and timely option for breast biopsy.
Therapeutic left-to-right shunting in heart failure
Abstract Heart failure with reduced or preserved ejection fraction is associated with elevated left atrial pressure at rest due to fluid overload or during exercise, leading to pulmonary venous congestion. Even with available treatments, heart failure hospitalizations remain high, and improvements in quality-of-life scores and functional capacity are modest. Thus, there is growing interest in non-pharmacological methods to decompress the left atrium and improve heart failure symptoms and outcomes. Left-to-right shunts have emerged as a potential therapeutic option to reduce left atrial hypertension, improve quality of life, and impact long-term outcomes. This nascent field carries both potential therapeutic promise and many unanswered questions. Recent data have questioned whether the effects of this therapy vary based on the left ventricular ejection fraction, pulmonary vascular resistance, and/or right ventricular structure and function. This review discusses the basis for left-to-right shunt therapies, synthesizes past and ongoing clinical trials, and offers future directions.
A Report of Two Uncommon Cases of Mycobacterium chelonae with Localized and Disseminated Skin and Soft Tissue Infection
Background: Mycobacterium chelonae is a ubiquitous, rapidly growing, nontuberculous mycobacteria that primarily affects immunocompromised patients. The most common presentation is an atypical, chronic skin and soft tissue infection. Due to its high resistance rate, early diagnosis based on clinical suspicion, risk factor assessment, and exposure history is crucial for initiating appropriate multi-drug treatment. Methods: We report two cases of M. chelonae skin and soft tissue infections, one presenting with localized disease and the other with disseminated involvement. One case had a specific exposure to fish-related activities, a risk factor more commonly associated with Mycobacterium marinum infections rather than M. chelonae. Results: One of the cases involved osteomyelitis and tenosynovitis which are rare presentations of M. chelonae infection. While the limbs are the most commonly affected sites in disseminated M. chelonae infections, involvement of the lower extremities, as seen in one of our cases, is rarely reported. Treatment posed challenges due to antibiotic resistance and patient tolerance. However, in both cases where follow up was possible, prolonged multi-drug therapy led to complete resolution of the lesions. Conclusions: These cases highlight the importance of considering M. chelonae in chronic skin and soft tissue infections, especially in patient with relevant exposures or immunosupression. Uncommon presentations require a high index of suspicion. Given the challenges of treatment resistance and patient tolerance, prolonged multi-drug therapy remains essential for successful outcomes.
P-1043. Risk Factors for Breakthrough Invasive Mold Infections in Patients with Hematologic Malignancies
Abstract Background Invasive mold infections (IMI) lead to significant morbidity and mortality in patients with hematologic malignancies. We provide patients deemed at higher risk mold active prophylaxis but still observe breakthrough IMIs. The purpose of this study was to evaluate risk factors associated with these breakthrough infections. Methods We conducted a retrospective cohort study of adult hematologic patients at 3 tertiary care medical centers from November 19, 2011 - August 6, 2021. Only IMI cases defined as proven or probable per EORTC/MSG criteria were included. Patients with IMIs who received a minimum of 7 days of mold active prophylaxis were classified as breakthrough infection. We performed logistical regression analysis to identify risk factors associated with breakthrough IMI. Results Majority of cases were probable IMIs, with 16 (28.6%) and 25 (15.7%) proven cases amongst breakthrough and non-breakthrough IMIs, respectively. Many variables indicative of weakened host immune system, including neutropenia and hypogammaglobulinemia, were associated with breakthrough IMIs, albeit not statistically significant (Table 1). Multivariate analysis revealed history of AML (OR 4.20, 95% CI 2.03-8.88; p < 0.001) and receipt of HCT (OR 3.37, 95% CI 1.46-8.11; p = 0.003) to be independent host risk factors for breakthrough IMI. Of all the pathogens, Fusarium (OR 4.38, 95% CI 1.56-12.56; p = 0.005) and Mucorales (OR 5.59, 95% CI 2.11-15.61; p < 0.001) were significantly likely to lead to breakthrough IMIs. 26 (47.3%) of the breakthrough IMIs were on appropriately dosed prophylaxis at the time of infection, with only 9 (16.4%) found to be subtherapeutic (Table 2). Overall, mortality was slightly higher amongst the breakthrough IMIs (51.8% vs 45.9%) but not significantly different (Figure 1). Conclusion In our cohort of probable/proven IMIs, we did not observe any significant difference in mortality between patients with breakthrough IMIs and those not on mold active prophylaxis. Even with appropriate prophylactic dosing, breakthrough infections occurred, irrespective of agent. Our study demonstrates that host risk factors and the causative pathogen are clinically more pertinent than the prophylaxis regimen in breakthrough IMIs. Disclosures Paschalis Vergidis, MD, MSc, AbbVie: Advisor/Consultant|Ansun Biopharma: Grant/Research Support|Cidara Therapeutics: Grant/Research Support|F2G: Grant/Research Support|Scynexis: Advisor/Consultant|Scynexis: Grant/Research Support
A Systematic Literature Review on the Burden of Disease for Patients With Moderate to Severe Acute Ischemic Stroke
Background: A vast amount of literature is available on the burden of acute ischemic stroke (AIS). Yet, most information on AIS burden does not stratify by stroke severity, and the inclusion of mild strokes (National Institute of Health Stroke Scale < 5) might obscure the true impact of moderate-to-severe AIS. Therefore, it is important to understand the literature as it pertains to the epidemiological, clinical, humanistic, and economic burden of moderate-to-severe AIS from a global perspective. Methods: A systematic literature review (SLR) was conducted, including articles published between January 2015 and June 2023. The clinical burden search focused on patients with moderate or severe AIS. Due to the paucity of evidence, the humanistic and economic burdens were evaluated based on overall AIS studies. Abstract and full-text screening were conducted by 2 reviewers, with data extraction completed by 1 reviewer. In all, 136 studies were included in the SLR. Results: AIS caused a substantial burden for patients and the healthcare system. The clinical burden of AIS (specifically severe AIS) resulted in high mortality and worse functional outcomes across multiple demographics (female sex, older age, and patients with comorbidities). The economic burden of overall AIS was substantial, with inpatient costs as the primary driver (a mean or median stay of 7 days). The highest inpatient costs were reported in South Korea ($45,180) and the United States ($38,470). Conclusions: The review highlighted the huge burden of moderate-to-severe AIS, with patients experiencing worse outcomes with increased stroke severity. Further focus is needed on outcomes relating to moderate-to-severe AIS to fully understand the burden of stroke in this patient population.
Increased Mortality in Kidney Transplant Recipients During the Delta/Omicron Era of the COVID‐19 Pandemic Despite Widespread Vaccination
ABSTRACTIntroductionThe incidence of mortality late in the pandemic, particularly after widespread vaccine availability, is not well understood. Herein, we elucidate the effect of this impact of the COVID pandemic as well as risk factors for mortality during it.MethodsThe primary end point was death with a functioning graft with secondary endpoints of mortality rates in subgroups and at different time intervals during the pandemic.ResultsDespite widespread vaccination, mortality rates for kidney transplant (KTx) recipients almost doubled during the COVID‐19 era (6.40 deaths per 100 person years vs. 3.54 pre‐COVID). Mortality increased in all racial/ethnic groups but increased more in Native Americans, Hispanics, and African Americans compared to non‐Hispanic Caucasians. The highest mortality rate occurred during the Delta and Omicron time frames. In contrast to the general population, mortality was more evenly spread across age groups in KTx recipients.ConclusionsMortality rates during the COVID‐19 era were extremely high, more than doubling in some racial/ethnic groups. We conclude that the KTx population was a particularly vulnerable group during the COVID‐19 era and suggests the need for further research into the management of variants in the future.
Outcomes Associated With Blastomycosis in Solid Organ and Hematopoietic Cell Transplant Recipients
ABSTRACT Introduction With reports of expanding epidemiology of blastomycosis across the United States, the purpose of this study was to evaluate the incidence and outcomes associated with blastomycosis in solid organ transplant (SOT) and hematopoietic cell transplant (HCT) recipients. Methods We conducted a retrospective case series of adult SOT and HCT recipients at a tertiary care medical center between January 1, 2005 and September 30, 2023. Cases were defined as culture‐proven blastomycosis. We performed descriptive statistical analysis to evaluate diagnosis, management, and outcomes (mortality) of blastomycosis in SOT. Results The cumulative incidence of blastomycosis was 0.11% with a median time to infection following transplant of 743 days. Of the 19 cases, the majority of patients were SOT recipients (90%). Supratherapeutic immunosuppression within 30 days of diagnosis was observed in 42% of cases with documented drug monitoring. Urine antigen testing was highly sensitive (100%). Fourteen (73.7%) patients received induction therapy with liposomal amphotericin B followed by azole therapy for a minimum of 12 months. Despite appropriate treatment, 1‐year mortality was high at 26.3%, with attributable mortality of 21.1%. Conclusions While rates of blastomycosis remain low among SOT and HCT recipients, infection is associated with poor posttransplant outcomes. Antigen testing can aid in timely assessment of disease severity and initiation of appropriate therapy. Among survivors, no relapses were observed while on lifelong secondary suppression. Future studies should aim to better define risk factors associated with developing blastomycosis and establish effective strategies for prevention.
Consensus Recommendations for Studies of Outflow Facility and Intraocular Pressure Regulation Using Ex Vivo Perfusion Approaches
Introduction: Considerable variation has been observed in the prevalence of monoclonal gammopathies across the globe. Although the prevalence of monoclonal gammopathy of undetermined significance (MGUS) has been evaluated in two hospital-based studies in India, no data exists on its prevalence in community-based settings amongst the rural Indian population. Objectives: To determine the prevalence of MGUS in a rural Indian population in a community-based setting. Methods: A cross-sectional study was conducted across 58 agrarian villages/hamlets of a tribal (aboriginals) district and 8 agrarian villages of a Non-Tribal district of Western India spreading over 2299 square miles (sq-mi), as part of SIMPLe (Screening Intervention for Myeloma and Prevention of Lifestyle diseases) study. For the complete study population, demographic details, medical history, and blood samples were collected after a thorough medical examination. Hemograms and serum protein electrophoresis (SPEP) were performed in all individuals. SPEP was performed using on-site capillary zone electrophoresis. Serum immunofixation electrophoresis (SIFE), and biochemistry (liver and renal function tests) were performed for those with abnormal SPEP graphs (those with M spike and those with abnormal bulges in beta-2 or gamma region suspicious of MGUS). Patients with monoclonal protein on SPEP or SIFE were further assessed for any smoldering/ multiple myeloma features. The data was analyzed using JMP ver. 17.2.0. Results: A total of 10,024 individuals were screened and data was analyzed for 9283 (8527 Tribal + 756 Non-tribal) individuals. The prevalence of MGUS in the study population was 62 (0.66%) and was 1.79% above the age of 55y (62 of 3447w). The median age of individuals with MGUS was 65y (IQR 59-72) with male preponderance. None of the patients satisfied the criteria for smoldering or multiple myeloma using IMWG criteria. The median Hb of the study population was 12g/dL (IQR 11.4-13). Among those with MGUS, the distribution of heavy and light chains was IgG - 83.33%, IgA - 16.67%, with none having IgM/ IgD paraprotein, Kappa - 50%, and Lambda - 50%. Two individuals only had light chain MGUS. There was no statistically significant difference between the tribal and non-tribal populations (aged >45y) in the incidence of MGUS (1.798% Vs. 1.745%, p=0.78), total protein levels (7.71 vs. 7.19 g/dL, p=0.87) and albumin-globulin ratio (1.54 vs 1.62, p=0.77) with numerically more patients having polyclonal gammaglobulinemia in the tribal population. The low Hb reflected the statistically lower Hb levels in the tribal population (9.1±4.2 Vs. 12.39±1.8g/dL, p-0.021) owing to concurrent hemoglobinopathies (sickle cell/ thalassemia traits). Conclusion: The prevalence of MGUS in the rural population of Western India is low at 0.66%, rising to 1.79% in individuals over 55 years, predominantly affecting older males, with IgG MGUS being the most common type. There are no significant differences in MGUS prevalence, total protein levels, or Albumin-globulin ratios between tribal and non-tribal populations over 45 years. Our study comprehensively describes the prevalence of MGUS in rural community settings in India. The background prevalence appears to be lower compared to the Western (both USA ~3% and European~5%) population.
The Outcomes of Adenovirus Infection in Kidney Transplant Recipients
ABSTRACTBackgroundAdenovirus (ADV) infection can lead to significant morbidity and mortality in immunocompromised patients, particularly in those with hematopoietic stem cells or solid organ transplants. The incidence of ADV infection in kidney transplant (KT) is not well‐defined as ADV is often asymptomatic and not routinely checked.MethodsThis retrospective case‐series study included KT and simultaneous pancreas‐KT (SPKT) recipients from January 1, 2008, to January 31, 2024, across three Mayo Clinic sites (Arizona, Florida, and Minnesota) with symptomatic adenovirus polymerase chain reaction cases. The primary outcomes were allograft function at various intervals post‐ADV infection, allograft, and patient survival.ResultsWe report one of the largest multi‐site case series regarding outcomes of ADV in KT with 17 patients. The median time to ADV infection was 30 weeks (5–74). Five patients (29%) developed disseminated infection. Nine patients (53%) of the entire cohort experienced graft loss within a median of 35 (4–168) weeks, with four (44%) of graft loss attributed to ADV. Nine patients (53%) developed rejections post‐ADV infection with a median of 4 (2–8) weeks after resolution. One patient died from acute hypoxic respiratory failure from ADV infection.ConclusionADV should be considered in KT/SPKT patients with renal dysfunction, hematuria, and with or without fever. Despite the low mortality rate, there is a significant risk of graft loss and rejection after ADV infection. It is crucial to screen for ADV and develop intervention strategies for treatment. Further multicenter studies are needed to better define, stage, and manage ADV infection. image