The national impact of the COVID-19 pandemic on U.S. prostate cancer community care.

5061 Background: We used data from a specialty-wide, community-based urology registry to determine trends in outpatient prostate cancer (PCa) care during the COVID-19 pandemic. Methods: 3,165 (̃ 25%) of US urology providers, representing 48 states and territories, participate in the American Urological Association Quality (AQUA) Registry, which collects data via automated extraction from electronic health record systems. We analyzed trends in PCa care delivery from 156 practices contributing data in 2019 and 2020. Risk stratification was based on prostate-specific antigen (PSA) at diagnosis, biopsy Gleason, and clinical T-stage, and we used a natural language processing algorithm to determine Gleason and T-stage from unstructured clinical notes. The primary outcome was mean weekly visit volume by PCa patients per practice (visits defined as all MD and mid-level visits, telehealth and face-to-face), and we compared each week in 2020 through week 44 (November 1) to the corresponding week in 2019. Results: There were 267,691 PCa patients in AQUA who received care between 2019 and 2020. From mid-March to early November, 2020 (week 10 – week 44) the magnitude of the decline and recovery varied by risk stratum, with the steepest drops for low-risk PCa (Table). For 2020, overall mean visits per day (averaged weekly) were similar to 2019 for the first 9 weeks (̃25). Visits declined to week 14 (18.19; a 31% drop from 2019), recovered to 2019 levels by week 23, and declined steadily to 11.89 (a 58% drop from 2019) as of week 44, the cut off of this analysis. Conclusions: Access to care for men with PCa was sharply curtailed by the COVID-19 pandemic, and while the impact was less for men with high-risk disease compared to those with low-risk disease, visits even for high-risk individuals were down nearly one-third and continued to fall through November. This study provides real-world evidence on the magnitude of decline in PCa care across risk groups. The impact of this decline on cancer outcomes should be followed closely.[Table: see text]

Risk prediction in medically treated chronic thromboembolic pulmonary hypertension

Background At present, there is no generally accepted comprehensive prognostic risk prediction model for medically treated chronic thromboembolic pulmonary hypertension (CTEPH) patients. Methods Consecutive medically treated CTEPH patients were enrolled in a national multicenter prospective registry study from August 2009 to July 2018. A multivariable Cox proportional hazards model was utilized to derive the prognostic model, and a simplified risk score was created thereafter. Model performance was evaluated in terms of discrimination and calibration, and compared to the Swedish/COMPERA risk stratification method. Internal and external validation were conducted to validate the model performance. Results A total of 432 patients were enrolled. During a median follow-up time of 38.73 months (IQR: 20.79, 66.10), 94 patients (21.8%) died. The 1-, 3-, and 5-year survival estimates were 95.5%, 83.7%, and 70.9%, respectively. The final model included the following variables: the Swedish/COMPERA risk stratum (low-, intermediate- or high-risk stratum), pulmonary vascular resistance (PVR, ≤ or > 1600 dyn·s/cm5), total bilirubin (TBIL, ≤ or > 38 µmol/L) and chronic kidney disease (CKD, no or yes). Compared with the Swedish/COMPERA risk stratification method alone, both the derived model [C-index: 0.715; net reclassification improvement (NRI): 0.300; integrated discriminatory index (IDI): 0.095] and the risk score (C-index: 0.713; NRI: 0.300; IDI: 0.093) showed improved discriminatory power. The performance was validated in a validation cohort of 84 patients (C-index = 0.707 for the model and 0.721 for the risk score). Conclusions A novel risk stratification strategy can serve as a useful tool for determining prognosis and guide management for medically treated CTEPH patients. Trial registration: ClinicalTrials.gov (Identifier: NCT01417338).

No difference in survival after HLA mismatched versus HLA matched allogeneic stem cell transplantation in Ewing sarcoma patients with advanced disease

Patients with advanced Ewing sarcoma (AES) carry a poor prognosis. Retrospectively, we analyzed 66 AES patients treated with allogeneic stem cell transplantation (allo-SCT) receiving HLA-mismatched (group A, n = 39) versus HLA-matched grafts (group B, n = 27). Median age at diagnosis was 13 years, and 15 years (range 3–49 years) at allo-SCT. The two groups did not differ statistically in distribution of gender, age, remission status/number of relapses at allo-SCT, or risk stratum. 9/39 (23%) group A versus 2/27 (7%) group B patients developed severe acute graft versus host disease (GvHD). Of patients alive at day 100, 7/34 (21%) group A versus 9/19 (47%) group B patients had developed chronic GvHD. In group A, 33/39 (85%) versus 20/27 (74%) group B patients died of disease and 1/39 (3%) versus 1/27 (4%) patients died of complications, respectively. Altogether 12/66 (18%) patients survived in CR. Median EFS 24 months after allo-SCT was 20% in both groups, median OS was 27% (group A) versus 17% (group B), respectively. There was no difference in EFS and OS in AES patients transplanted with HLA-mismatched versus HLA-matched graft in univariate and multivariate analyses. In this analysis, CR at allo-SCT is a condition for survival (p < 0.02).

Risk prediction models and scores in hypertrophic cardiomyopathy

: Hypertrophic cardiomyopathy (HCM) has historically been linked with sudden cardiac death (SCD). Currently, it is well established that only a subset of patients is at the highest risk stratum for such a catastrophic event. Detection of patients belonging to this high-risk category can allow for timely defibrillator implantation, changing the natural history of HCM. Inversely, device implantation in patients deemed at low risk leads to an unnecessary burden of device complications with no apparent protective benefit. Previous studies have identified a series of markers, now considered as established risk factors, with genetic testing and newer imaging allowing for the detection of novel, highly promising indices of increased risk for SCD. Despite the identification of a number of risk factors, there is noticeable discrepancy on the utility of such factors for risk stratification between the current American and European guidelines. We sought to systematically review the data available on these two approaches, presenting their rationale and respective predictive capacity, also discussing the potential of novel markers to augment the precision of currently used risk stratification models for SCD in HCM.

Relationship between AF-risk, ischemic stroke AF related, and cognitive dysfunction in population older than 65 years-old. MIND-COR study

Background The number of individuals with atrial fibrillation (AF) and cognitive impairment (CI) will increase 150% by 2050. Purpose The main objective of this study is to elucidate the relationship between AF-risk, the ischemic stroke, and the cognitive dysfunction. Methods Multicenter, longitudinal and retrospective community-based study of cohort ≥65 year-old without AF between 1/1/2013–31/12/2017 conducted by 11 Primary Care teams. Variables: sociodemographic; Charlson, CHA2DS2VASc score, Pfeiffer and NIHSS scores from records database (primary care, specialty clinics and hospitalizations). Kaplan-Meier to evaluate mortality. Descriptive analysis Cox regression to create an AF risk score was developed: Q1 (lowest AF-risk)-Q4 (highest AF-risk). Incidence density (ID) rate per 1000/people/years of AF and stroke; and CI prevalence were calculated by risk stratum. Approved by Ethics Committee of IDIAP Jordi Gol PP15/047. Results 46706 (women 49%) cases, aged 78.01±11.9 and average follow-up time 4.9±0.7 years. Q4 risk group (Q4) was characterized by women's (85.2%), highest age, AF, stroke, CI and mortality. 1244 AF were diagnosed (ID 10.5/1000/year's IC95% 9.9–11.2). Q3–4 levels included 53.8% of AF in men vs 84.2% in women. 214 strokes were diagnosed and 78.5% happened in Q3–4, especially among women (88.1%). The stroke and AF were diagnosed simultaneously in 9.8% (ID 5.8/1000/year CI95% 3.4–8.1) and showed higher severity (NIHSS 7.25±8.62 vs 4.55±5.74, p=0.002). The cognitive impairment increased from 2.6% (Q1) up to 16.4% (Q4) significantly higher in women (17.6% vs 12.1%) Conclusions Differences were found according to gender and risk groups. The risk-based screening could improve the effectiveness of AF screening in primary care. Funding Acknowledgement Type of funding source: None

The Effect of Risk of Maturation Failure and Access Type on Arteriovenous Access-Related Costs among Hemodialysis Patients

BackgroundSeveral studies report lower costs associated with attaining and maintaining patency for arteriovenous (AV) fistulas as compared to AV grafts among patients receiving hemodialysis. However, these costs may vary according to the AV access’s risk of failure to mature (FTM). The aim of this study was to examine the effect of AV access type and risk of FTM on the total costs of attaining and maintaining AV access patency over 1, 3, and 5 years postcreation, among incident accesses.MethodsAll first AV access creations (January 1, 2002–January 1, 2018), revisions/resections, and interventions from a single academic institution were prospectively captured. The units costs (from 2011 in CA$) were estimated primarily through the provincial patient Ontario Case Costing Initiative database. The present value of total vascular access-related costs from a third-party payer perspective was calculated by multiplying specific unit costs by the number of AV access creations, revisions/resections, and interventions from the date of creation to 1, 3, and 5 years post creation. The potential associations of AV access type and FTM risk stratum with AV access cost were examined using log-linear models and generalized estimating equations.ResultsA total of 906 patients were included in the study, of which 696 had fistulas and 210 had grafts. The median present value of total costs to attain and maintain AV access over 1, 3, and 5 years was positively associated with the highest FTM risk stratum in all models. It was not associated with AV access type when the interaction between AV access type and FTM risk stratum was considered.ConclusionsThe costs of attaining and maintaining AV access were increased among patients with high/very high FTM risk. Risk of FTM, related interventions, and costs should be considered when choosing vascular access type for an individual patient.

P327 Concordance between regadenoson stress echocardiography and spect-MIBI (99mTc) in patients with suspected myocardial ischemia

Background Regadenoson is a selective A2A adenosine receptor agonist approved for the detection of myocardial with SPECT-MIBI. To date, few studies have appraised the utility of this drug using transthoracic echocardiography with the same purpose. We designed this prospective study to evaluate the diagnostic agreement between these two techniques used simultaneously to detect myocardial ischemia. We report our first results evaluating the concordance between both techniques. Methods Patients enrolled were referred to our clinic for the evaluation of chest pain. Myocardial perfusion imaging was performed with regadenoson (400 µg ) which was injected before 99mTc-MIBI. Stress and rest sets of images were evaluated for relative uptake of the radiotracer in order to detect and characterize perfusion defects. The echocardiogram was acquired 60-90 seconds after the administration of the drug using a standardized technique. Two independent observers (one cardiologist and one specialist in nuclear medicine) interpreted the images, both unaware of the result of the complementary technique. Results One hundred twenty five patients were included, 69 (55%) of them males. Median age was 73 years (IQR 65-79). One hundred seventeen patients had both studies interpretable. Thirty-nine (32.5%) patients had had a diagnosis of ischemic heart disease before the study (either a myocardial infarction or a coronary revascularization). The median pre-test probability of coronary artery disease in those without a true previous diagnosis was 30.5% (16.0-50.8), being 50% in the intermediate risk (15-85%) and 49% in the low risk stratum (less than 15%). Significant reductions is systolic and diastolic blood pressure were detected with regadenoson [systolic 134 (21) mmHg Vs 131 (23) mmHg, p &lt; 0.001; diastolic: 78 (12) mmHg Vs 73 (13) mmHg, p &lt; 0.001], with a striking increase in heart rate: 67 (13) bpm Vs 91 (17) bpm, p &lt; 0.001. More patients had a SPECT test showing myocardial ischemia (28% Vs 16%; p &lt; 0.001). Agreement between both tests were 84%. The kappa index obtained from this sample was 0.34 (CI95% 0.15-0.53). Segregating those patients without a history of coronary artery disease (n = 81), the positive test rate were 14% for echo and 20% for SPECT-MIBI (p = 0.019). Kappa index was even lower: 0.29 (CI95% 0.02-0.56). Conclusions. SPECT-MIBI provides more positive tests than stress echocardiography when regadenoson is used as the stressor agent. The concordance between tests is low.

Retrospective Analysis of Adverse Drug Events Between Nafcillin Versus Cefazolin for Treatment of Methicillin-Susceptible Staphylococcus aureus Infections

Background: Nafcillin or cefazolin are drugs of choice for methicillin-susceptible Staphylococcus aureus (MSSA) infections. Prior studies indicate a higher incidence of acute kidney injury (AKI) with nafcillin, although AKI classification and time to occurrence is not well described. Objective: To characterize the incidence and time to adverse drug events for nafcillin versus cefazolin in the inpatient setting. Methods: A retrospective cohort study evaluated hospitalized, adult patients receiving intravenous nafcillin or cefazolin for treatment of MSSA infection. Incidence and time to AKI based on RIFLE criteria were measured. Secondary end points included antibiotic discontinuation and incidence of neutropenia, thrombocytopenia, elevated transaminases, and Clostridioides difficile infection (CDI). Results: Of 324 patients who received nafcillin (n = 119) or cefazolin (n = 205), higher rates of AKI were found for nafcillin versus cefazolin (19% vs 2%, respectively; P < 0.0001). Median time to AKI with nafcillin was 6.5 days (range, 3-14 days). The majority of patients were classified as RIFLE “Risk” stratum. Nafcillin treatment discontinuations were more frequent than for cefazolin (17.6% vs 0.9%, respectively; P < 0.0001). Nafcillin was an independent predictor of AKI (odds ratio = 12.4; 95% CI = 4.14-47.60, P < 0.0001). No differences in neutropenia, thrombocytopenia, elevated transaminases, or CDI were observed. Conclusion and Relevance: Nafcillin displayed higher rates of AKI at a median of 1 week of therapy, which provides a framework for clinician monitoring and consideration of antibiotic modification. Most patients developed “Risk” class AKI (RIFLE classification), which may be reversible with prompt intervention.

Preventive Pharmacotherapy for Cardiovascular Disease: A Modelling Study Considering Health Gain, Costs, and Cost-Effectiveness when Stratifying by Absolute Risk

Cardiovascular disease (CVD) is the leading cause of death internationally. We aimed to model the impact of CVD preventive double therapy (a statin and anti-hypertensive) by clinician-assessed absolute risk level. An established and validated multi-state life-table model for the national New Zealand (NZ) population was adapted. The new version of the model specifically considered the 60–64-year-old male population which was stratified by risk using a published NZ-specific CVD risk equation. The intervention period of treatment was for five years, but a lifetime horizon was used for measuring benefits and costs (a five-year horizon was also implemented). We found that for this group offering double therapy was highly cost-effective in all absolute risk categories (eg, NZ$1580 per QALY gained in the >20% in 5 years risk stratum; 95%UI: Dominant to NZ$3990). Even in the lowest risk stratum (≤5% risk in 5 years), the cost per QALY was only NZ$25,500 (NZ$28,200 and US$19,100 in 2018). At an individual level, the gain for those who responded to the screening offer and commenced preventive treatment ranged from 0.6 to 4.9 months of quality-adjusted life gained (or less than a month gain with a five-year horizon). Nevertheless, at the individual level, patient considerations are critical as some people may decide that this amount of average health gain does not justify taking daily medication.