US Registry Research Articles

Abstract 15281: Patient and System-Related Delays in Presentation and Invasive Coronary Angiography in Patients Presenting With Acute Myocardial Infarction Secondary to Spontaneous Coronary Artery Dissection: A Report of the ISCAD Registry

Introduction: Spontaneous coronary artery dissection (SCAD) is an important cause of acute coronary syndrome especially in young patients. Factors associated with delays in presentation and care delivery are not well understood. Methods: We used data from the iSCAD Registry which is a prospective multicenter US registry of patients with SCAD. Early vs. delayed hospital presentation (< 24 vs. ≥ 24 hours), and early vs. delayed coronary angiography (time from hospital presentation to coronary angiography < 24 vs. ≥ 24 hours) for SCAD patients with AMI were assessed. Patient characteristics, and in-hospital events were compared between the two groups. Factors associated with delayed presentation and angiography were explored using multivariable logistic regression. Results: A total of 346 SCAD (294 white, 52 non-white) patients presented with STEMI (34%) or NSTEMI; 57 had a delayed presentation to the hospital after symptoms onset. No significant factors were identified for delays in seeking care. However, white race was less likely to have delayed invasive coronary angiography (multivariable OR=0.38; 95% CI 0.19 to 0.76; p=0.0059). Patients undergoing delayed angiography were also more likely to be medically managed (91.7% vs. 69.8%, p=0.0008), but less likely to receive dual antiplatelet therapy (57.0% vs. 73.1%, p=0.007). In-hospital outcomes were similar between the two groups. Conclusion: In this study, no patient-related variables were identified that predicted a delay in presentation with AMI secondary to SCAD. On the other hand, non-white race was associated with delays in performing invasive coronary angiography. Further investigation is required to determine the factors contributing to this potential disparity.

Comparison of Evaluations for Heart Transplant Before Durable Left Ventricular Assist Device and Subsequent Receipt of Transplant at Transplant vs Nontransplant Centers

In 2020, the Centers for Medicare & Medicaid Services revised its national coverage determination, removing the requirement to obtain review from a Medicare-approved heart transplant center to implant a durable left ventricular assist device (LVAD) for bridge-to-transplant (BTT) intent at an LVAD-only center. The association between center-level transplant availability and access to heart transplant, the gold-standard therapy for advanced heart failure (HF), is unknown. To investigate the association of center transplant availability with LVAD implant strategies and subsequent heart transplant following LVAD implant before the Centers for Medicare & Medicaid Services policy change. A retrospective cohort study of the Society of Thoracic Surgeons Intermacs multicenter US registry database was conducted from April 1, 2012, to June 30, 2020. The population included patients with HF receiving a primary durable LVAD. LVAD center transplant availability (LVAD/transplant vs LVAD only). The primary outcomes were implant strategy as BTT and subsequent transplant by 2 years. Covariates that might affect listing strategy and outcomes were included (eg, patient demographic characteristics, comorbidities) in multivariable models. Parameters for BTT listing were estimated using logistic regression with center-level random effects and for receipt of a transplant using a Cox proportional hazards regression model with death as a competing event. The sample included 22 221 LVAD recipients with a median age of 59.0 (IQR, 50.0-67.0) years, of whom 17 420 (78.4%) were male and 3156 (14.2%) received implants at LVAD-only centers. Receiving an LVAD at an LVAD/transplant center was associated with a 79% increased adjusted odds of BTT LVAD designation (odds ratio, 1.79; 95% CI, 1.35-2.38; P < .001). The 2-year transplant rate following LVAD implant was 25.6% at LVAD/transplant centers and 11.9% at LVAD-only centers. There was an associated 33% increased rate of transplant at LVAD/transplant centers compared with LVAD-only centers (adjusted hazard ratio, 1.33; 95% CI, 1.17-1.51) with a similar hazard for death at 2 years (adjusted hazard ratio, 0.99; 95% CI, 0.90-1.08). Receiving an LVAD at an LVAD-transplant center was associated with increased odds of BTT intent at implant and subsequent transplant receipt for patients at 2 years. The findings of this study suggest that Centers for Medicare & Medicaid Services policy change may have the unintended consequence of further increasing inequities in access to transplant among patients at LVAD-only centers.

Efficacy and Safety of Ketamine vs Electroconvulsive Therapy Among Patients With Major Depressive Episode

Whether ketamine is as effective as electroconvulsive therapy (ECT) among patients with major depressive episode remains unknown. To systematically review and meta-analyze data about clinical efficacy and safety for ketamine and ECT in patients with major depressive episode. PubMed, MEDLINE, Cochrane Library, and Embase were systematically searched using Medical Subject Headings (MeSH) terms and text keywords from database inception through April 19, 2022, with no language limits. Two authors also manually and independently searched all relevant studies in US and European clinical trial registries and Google Scholar. Included were studies that involved (1) a diagnosis of depression using standardized diagnostic criteria, (2) intervention/comparator groups consisting of ECT and ketamine, and (3) depressive symptoms as an efficacy outcome using standardized measures. Data extraction was completed independently by 2 extractors and cross-checked for errors. Hedges g standardized mean differences (SMDs) were used for improvement in depressive symptoms. SMDs with corresponding 95% CIs were estimated using fixed- or random-effects models. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline was followed. Efficacy outcomes included depression severity, cognition, and memory performance. Safety outcomes included serious adverse events (eg, suicide attempts and deaths) and other adverse events. Six clinical trials comprising 340 patients (n = 162 for ECT and n = 178 for ketamine) were included in the review. Six of 6 studies enrolled patients who were eligible to receive ECT, 6 studies were conducted in inpatient settings, and 5 studies were randomized clinical trials. The overall pooled SMD for depression symptoms for ECT when compared with ketamine was -0.69 (95% CI, -0.89 to -0.48; Cochran Q, P = .15; I2 = 39%), suggesting an efficacy advantage for ECT compared with ketamine for depression severity. Significant differences were not observed between groups for studies that assessed cognition/memory or serious adverse events. Both ketamine and ECT had unique adverse effect profiles (ie, ketamine: lower risks for headache and muscle pain; ECT: lower risks for blurred vision, vertigo, diplopia/nystagmus, and transient dissociative/depersonalization symptoms). Limitations included low to moderate methodological quality and underpowered study designs. Findings from this systematic review and meta-analysis suggest that ECT may be superior to ketamine for improving depression severity in the acute phase, but treatment options should be individualized and patient-centered.

Associations of anaemia and race with peripartum transfusion in three United States datasets.

Transfusion complicates a significant proportion of births in the United States, and Black women have greater prevalence of transfusion at delivery than White women. Antepartum anaemia, a risk factor for peripartum transfusion, is more common among Black women than White women. We aimed to describe the racial distribution of antepartum anaemia in three national datasets and to evaluate the peripartum transfusion rate and characteristics of transfusion recipients, to investigate disparities in haemostatic outcomes. We performed a retrospective analysis of Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network Cesarean Registry (CR), NICHD Consortium on Safe Labor Registry (CSL), and a cohort of deliveries at Universal Health Services hospitals (UHS). Univariable associations and multivariable logistic regressions were calculated between race, anaemia and transfusion. Covariates included age, parity, smoking, body mass index, type of insurance, and delivery mode. We included n=56,964 deliveries from CR (28% Black), 87,465 from UHS (12% Black), and 140,324 from CSL (24% Black). Anaemia prevalence was 8% in CR, 7% in UHS, and 13% in CSL. Anaemia was more common among Black patients (ORs 2.52, 2.61, and 1.48 respectively) and was associated with transfusion in all databases (ORs 6.46 [95% CI 5.78-7.22]; 5.79 [4.74-7.27]; 1.27 [1.18-1.37] respectively). After adjusting for covariates, Black patients had greater odds of transfusion than non-Black patients in CR (aOR 1.32 [1.16-1.50]), but not in UHS or CSL (aORs 1.19 [0.89-1.59] and 0.40 [0.36-0.44] respectively). In our retrospective cohort study using three US registries, we emphasized the link between anaemia and transfusion. Although anaemia was more prevalent among Black patients, the race-transfusion relationship differed between databases, indicating other unexplored factors are involved.

325P Early-onset colorectal cancer in the United States: Trends in prevalence, stage, and survival

Most cases with colorectal cancer (CRC) have been historically reported in older age population. There have been documented observations, however, on the rise of number of patients presenting with CRC at earlier-than-expected age. The national cancer institute Surveillance, Epidemiology, and End Results (SEER) program provides an opportunity for tracking trends of different cancer diagnoses in the US over time as it has been compiling data from different US registries since 1975. We used data from SEER to explore real-world trends in CRC diagnosis at young age using different cutoffs for defining early onset disease. Moreover, we compared stage and survival data between patients with early onset and late onset disease. Using SEER Research Database (8 reg; Nov 2021 Submission), we included cases diagnosed with CRC between 1975 and 2015 with complete relevant clinical data. Data including age at diagnosis, year at diagnosis, summary stage, and survival were exported to SPSS where Chi-Square test and Log-rang test were used to explore statistical significance for potential comparisons. We used different cutoffs for defining early-onset including age <30, age <40, age <45, and age <50. Upon analyzing 423,069 cases diagnosed between 1975 and 2015, there is a substantial increase in the proportion of cases diagnosed with CRC at younger age populations using different cutoffs for defining early-onset disease (Table). Patients diagnosed at earlier age were more likely to have distant metastasis compared to patients with older age at diagnosis regardless of the used age cutoff (all p < 0.05). However, overall survival was significantly longer in patients with early-onset disease compared to those with late-onset (all p < 0.05).Table: 325P1975-19841985-19941995-20042005+Age < 300.3%0.3%0.4%0.6%Age < 401.6%1.8%2.2%2.8%Age < 453.1%3.5%4.5%5.7%Age < 505.8%6.2%8.5%10.9% Open table in a new tab There is a substantial increase in the proportion of cases with CRC diagnosed at young age who are more likely to present with distant spread compared to cases diagnosed at old age. However, overall survival remains higher in this age population.

Association of health care utilization and costs with patient-reported outcomes in patients with ankylosing spondylitis.

BACKGROUND: Interventions for ankylosing spondylitis (AS) have improved patient-reported outcomes (PROs) in clinical studies. However, limited data exist associating these improvements with health care resource utilization (HCRU) or cost savings. Few studies have evaluated the economic impact of patient-reported physical status and related disease burden in patients with AS in the United States. OBJECTIVE: To assess the association of PRO measures with HCRU and health care costs in patients with AS from a national US registry. METHODS: This cohort study included adults with a diagnosis of AS enrolled in the FORWARD registry from July 2009 to June 2019 who completed at least 1 questionnaire from January 2010 to December 2019 and completed the Health Assessment Questionnaire Disability Index (HAQ-DI) (0-3) and/or Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (0-10). Patient-reported data for demographics, clinical characteristics, and PROs were collected through questionnaires administered biannually and reported from the most recent questionnaire. Patient-reported HCRU and total health care costs (2019 US dollars) for hospitalizations, emergency department (ED) visits, outpatient visits, diagnostic tests, and procedures were captured during the 6 months prior to the most recent survey completion. The relationship between HAQ-DI or BASDAI and HCRU outcomes was assessed using negative binomial regression models, and the relationship between HAQ-DI or BASDAI and the cost outcomes was evaluated using generalized linear models with γ distribution and log-link function. RESULTS: Overall, 334 patients with AS who completed the HAQ-DI (n = 253) or BASDAI (n = 81) were included. The mean (SD) HAQ-DI and BASDAI scores at the time of patients' most recent surveys were 0.9 (0.7) and 3.7 (2.3), respectively. HAQ-DI score was positively associated with number of hospitalizations, ED visits, outpatient visits, and diagnostic tests, whereas BASDAI was not associated with HCRU outcomes. Overall annualized mean (SD) total health care, medical, and pharmacy costs for patients with AS were $44,783 ($40,595); $6,521 ($12,733); and $38,263 ($40,595), respectively. Annualized total health care, medical, and pharmacy costs adjusted for confounders increased by 35%, 76%, and 26%, respectively, for each 1.0-unit increase in HAQ-DI score (coefficient [95% CI]: 1.35 [1.15-1.58], 1.76 [1.22-2.55]; both P < 0.01 and 1.26 [1.04-1.52]; P < 0.05, respectively); BASDAI score was not significantly associated with cost outcomes. CONCLUSIONS: Higher HAQ-DI scores were associated with higher HCRU and total health care costs among patients with AS in FORWARD, but BASDAI scores were not. These findings indicate that greater functional impairment may impose an increased economic burden compared with other patient-reported measures of AS. DISCLOSURES: A. Ogdie has received consulting fees from Amgen, AbbVie, Bristol Myers Squibb, Celgene, CorEvitas (formerly Corrona), Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB and has received grant support from the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases, Rheumatology Research Foundation, National Psoriasis Foundation, Pfizer (University of Pennsylvania), Amgen (FORWARD), and Novartis (FORWARD). M. Hwang has received consulting fees from Novartis and UCB and has received grant support (5KL2TR003168-03) from the University of Texas Health Science Center at Houston Center of Clinical and Translational Sciences KL2 program. P. Veeranki and J. Shafrin were employees of PRECISION-heor at the time of this analysis. A. Portelli and S. Sison are employees of PRECISION-heor. S. Pedro does not have anything to disclose. N. Kim was a postdoctoral fellow at the University of Texas at Austin and Baylor Scott and White Health, providing services to Novartis at the time of this study. E. Yi is an employee of Novartis. K. Michaud received grant funding from the Rheumatology Research Foundation at the time of this analysis. This study was funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ.

Access to kidney transplantation among pediatric candidates with prior solid organ transplants in the United States.

Pediatric kidney transplant candidates require timely access to transplant to optimize growth and neurodevelopmental outcomes. We studied access to transplant for pediatric candidates with prior organ transplants. We used US registry data to identify pediatric kidney transplant candidates added to the waiting list 2015-2019 and used competing risk regression to study the association between prior transplant status and probability of receiving a kidney transplant, treating wait-list removal and death as competing events. Of 4962 pediatric kidney transplant candidates included, 89% had no prior transplant and 11% had received a prior organ transplant (kidney 87%, liver 5%, heart 5%). Prior transplant recipients were older at listing (median 15 vs. 12 years) and more likely to have PRA≥98% (22% vs. 0.3%) (both p < .001). There was no significant difference in the proportion of candidates from each group who were preemptively wait-listed. Unadjusted competing risk regression showed a lower risk of kidney transplant after wait-listing among candidates with prior organ transplant (HR 0.52, 95%CI 0.47-0.59, p < .001). This association remained significant after adjusting for candidate characteristics (HR 0.73, 95%CI 0.63-0.83, p < .001). Among deceased donor kidney recipients, median KDPI was similar between groups, but recipients with prior transplants were more likely to receive kidneys from donors with hypertension (4% vs. 1%, p=.01) and donors after cardiac death (11% vs. 4%, p < .001). Pediatric kidney transplant candidates with prior organ transplants have reduced access to transplant after wait-listing. Allocation system changes are needed to improve timely access to transplant for this vulnerable group.

Implementation and evaluation of Illness Management and Recovery (IMR) in mandated forensic psychiatric care – Study protocol for a multicenter cluster randomized trial

IntroductionForensic mental health care is hampered by lack of evidence-based treatments. The Swedish forensic mental health population consists of patients suffering from severe illnesses such as schizophrenia and bipolar disorders, similar to populations in international studies. Illness Management and Recovery (IMR) is an intervention for patients with serious mental illness, based on psychoeducational, cognitive-behavioral and motivational components. The purpose is to strengthen participants’ illness management skills and recovery. ObjectiveTo test effectiveness of IMR within forensic mental health by comparing it to treatment as usual. MethodThis is a cluster-randomized controlled trial. Patients in forensic mental health inpatient units are randomized to an active (IMR) or a control condition (treatment as usual). Clustering of patients is based on ward-units where inpatients are admitted. Patients in the active condition receive two group and one individual IMR sessions per week. The treatment phase is estimated to last nine months. Outcomes include illness related disability, illness management skills, sense of recovery, hope, mental health and security related problems. Outcomes are measured at baseline, four months into treatment, at treatment completion and at three months follow-up. Staff experiences of implementing IMR will be explored by a self-report measure and semi-structured interview based on Normalization Process Theory. Ethics and disseminationThe study is approved by the Swedish Ethical Review Authority (Registration No. 2020–02046). Participation will be voluntary based on written informed consent. Results will be disseminated through peer-reviewed articles and conferences. The study is registered in the US registry of clinical trials (NCT04695132).

Trends in the procurement and discard of kidneys from deceased donors with acute kidney injury

Kidney allocation trends from deceased donors with acute kidney injury (AKI) have not been characterized since initial Kidney Donor Profile Index reporting in 2012 and its use under the revised Kidney Allocation System (KAS) in 2014. We conducted a retrospective analysis of US registry data to characterize kidney procurement and discard trends in deceased donors with AKI, defined by ≥50% or ≥0.3mg/dl (≥4.0mg/dl or ≥200% for stage 3) increase in terminal serum creatinine from admission. From 2010 to 2020, 172410kidneys were procured from 93341 deceased donors 16years or older; 34984kidneys were discarded (17559 from AKI donors). The proportion of stage 3 AKI donors doubled from 6% (412/6841) in 2010 to 12% (1365/11493) in 2020. Procurement of stage 3 AKI kidneys increased from 51% (423/824) to 80% (2183/2730). While discard of stage 3 AKI kidneys increased from 41% (175/423) in 2010 to 44% (960/2183) in 2020, this increase was not statistically significant in interrupted time-series analysis following KAS implementation (slope difference -0.41 [-3.22, 2.4], and level change 3.09 [-6.4, 12.6]). In conclusion, the absolute number of stage 3 AKI kidneys transplanted has increased. Ongoing high discard rates of these kidneys suggest opportunities for improved utilization.

Comorbidities Associated with Hospitalization and Progression Among Adolescents with Symptomatic Coronavirus Disease 2019

ObjectiveTo identify subgroups likely to benefit from monoclonal antibody and antiviral therapy by evaluating the relationship between comorbidities and hospitalization among US adolescents with symptomatic coronavirus disease 2019 (COVID-19).Study designWe analyzed the relationship between presence of comorbidities and need for hospitalization within 28 days of COVID-19 diagnosis for adolescents aged 12-17 years listed in the Pediatric COVID-19 US registry, a multicenter retrospective cohort of US pediatric patients with COVID-19. Comorbidities assessed included obesity, chronic kidney disease (CKD), diabetes, immunosuppressive disease or treatment, sickle cell disease (SCD), heart disease, neurologic disease/neurodevelopmental disorders, and pulmonary disease (excluding patients with mild asthma). We used multivariable logistic regression to determine race/ethnicity-adjusted associations between comorbidities and hospitalization.ResultsA total of 1877 patients met our inclusion criteria, of whom 284 (15%) were hospitalized within 28 days of their COVID-19 diagnosis. In a race/ethnicity-adjusted model, the following comorbidities were independently associated with increased odds of hospitalization: SCD (aOR, 6.9; 95% CI, 3.0-15.9), immunocompromising condition (aOR, 6.4; 95% CI, 3.8-10.8), obesity (aOR, 3.2; 95% CI, 2.1-4.9), diabetes (aOR, 3.0; 95% CI, 1.4-6.2), neurologic disease (aOR, 2.8; 95% CI, 1.8-4.3), and pulmonary disease (excluding mild asthma) (aOR, 1.9; 95% CI, 1.2-3.1). Heart disease and CKD were not independently associated with hospitalization.ConclusionsSCD, immunocompromising conditions, obesity, diabetes, neurologic disease, and pulmonary disease (excluding mild asthma) were associated with hospitalization for symptomatic COVID-19. Adolescents with acute COVID-19 and these comorbidities should be prioritized for consideration of therapy to avert hospitalization.

Incidence, Clinical Correlates, and Outcomes of Pulmonary Hypertension After Kidney Transplantation: Analysis of Linked US Registry and Medicare Billing Claims.

The incidence, risks, and outcomes associated with pulmonary hypertension (P-HTN) in the kidney transplant (KTx) population are not well described. We linked US transplant registry data with Medicare claims (2006-2016) to investigate P-HTN diagnoses among Medicare-insured KTx recipients (N = 35 512) using billing claims. Cox regression was applied to identify independent correlates and outcomes of P-HTN (adjusted hazard ratio [aHR] 95%LCLaHR95%UCL) and to examine P-HTN diagnoses as time-dependent mortality predictors. Overall, 8.2% of recipients had a diagnostic code for P-HTN within 2 y preceding transplant. By 3 y posttransplant, P-HTN was diagnosed in 10.310.6%11.0 of the study cohort. After adjustment, posttransplant P-HTN was more likely in KTx recipients who were older (age ≥60 versus 18-30 y a HR, 1.912.403.01) or female (aHR, 1.151.241.34), who had pretransplant P-HTN (aHR, 4.384.795.24), coronary artery disease (aHR, 1.051.151.27), valvular heart disease (aHR, 1.221.321.43), peripheral vascular disease (aHR, 1.051.181.33), chronic pulmonary disease (aHR, 1.201.311.43), obstructive sleep apnea (aHR, 1.151.281.43), longer dialysis duration, pretransplant hemodialysis (aHR, 1.171.371.59), or who underwent transplant in the more recent era (2012-2016 versus 2006-2011: aHR, 1.291.391.51). Posttransplant P-HTN was associated with >2.5-fold increased risk of mortality (aHR, 2.572.843.14) and all-cause graft failure (aHR, 2.422.642.88) within 3 y posttransplant. Outcome associations of newly diagnosed posttransplant P-HTN were similar. Posttransplant P-HTN is diagnosed in 1 in 10 KTx recipients and is associated with an increased risk of death and graft failure. Future research is needed to refine diagnostic, classification, and management strategies to improve outcomes in KTx recipients who develop P-HTN.

Leflunomide-induced liver injury: Differences in characteristics and outcomes in Indian and US registries.

Leflunomide, a disease-modifying anti-rheumatic drug, has been associated with elevations of serum aminotransferases. Herein, we describe the clinical, laboratory features and outcomes of 17 patients with leflunomide/teriflunomide hepatotoxicity from two large drug-induced liver injury (DILI) registries. Consecutive, adjudicated cases of leflunomide (n=16)-or teriflunomide (n=1)-related DILI from a single centre in Bangalore, India and the multicentre US Drug-Induced Liver Injury Network (DILIN) were reviewed. Nine (0.8%) of the 1070 Indian patients and 8 (0.5%) of the 1400 DILIN patients fulfilled the criteria for DILI because of leflunomide- or teriflunomide. 89% of the Indian cases were women and all were associated with severe cutaneous adverse reaction (SCAR) and a median drug latency of 49days, whereas 37.5% of the DILIN cases were female, none exhibited SCAR and the median drug latency was 166days. Hepatocellular injury (70%) was more common in women than men (92% vs. 20%) and was associated with younger mean age (41 vs. 59years), higher peak INR (2.3 vs. 1.2) and higher mortality (58% vs. 0%). Mortality was observed in six patients from India (2 of the three with myocarditis) and one received liver transplantation from the USA. Leflunomide-induced liver injury is predominantly hepatocellular. Leflunomide hepatotoxicity is more likely accompanied by SCAR, a short latency and a higher mortality in the Indian cohort, with a predominance of females, compared to US DILIN patients. The differences in skin involvement, immunoallergic features and outcomes among subjects from India vs. the USA suggest that genetic or environmental factors are important in the pathogenesis of liver injury.

Association Between Endovascular Therapy Time to Treatment and Outcomes in Patients With Basilar Artery Occlusion.

Basilar artery occlusion (BAO) is a devastating condition without definitive evidence to guide treatment. Whereas the association between faster treatment times with endovascular therapy (EVT) and better outcomes in anterior circulation is well established, whether this relationship exists for patients with BAO is not well delineated. We used individual-level patient data from the Get With The Guidelines-Stroke nationwide US registry prospectively collected from January 2015 to December 2019. We identified individuals with BAO treated with EVT within 24 hours of symptom onset. The primary outcomes examined were in-hospital mortality, discharge home, ambulatory at discharge, independent at discharge (modified Rankin Scale score 0 to 2), substantial reperfusion (modified Thrombolysis in Cerebral Infarction score 2b or 3), and symptomatic intracranial hemorrhage. Using logistic regression models, we evaluated the association between time from symptom onset to treatment with EVT and outcomes. Among 3015 patients with BAO treated with EVT, the mean age was 65.9 years, 38.8% were women, and the median National Institutes of Health Stroke Scale score at presentation was 17 (interquartile range, 8-26). Median onset to EVT time was 406 minutes (interquartile range, 252-688). From 2015 to 2019, there was an overall increase in the median onset to EVT times (380-411 minutes; P=0.016) but no significant change in the proportion of patients treated within 6 hours of symptom onset (48.4%-44.0%; P=0.17). After risk adjustment for patient and hospital-level factors, there were significantly lower odds of in-hospital mortality (adjusted odds ratio [aOR], 0.55 [95% CI, 0.45-0.68]) and symptomatic intracranial hemorrhage (aOR, 0.52 [95% CI, 0.32-0.84]) and significantly higher odds of ambulation at discharge (aOR, 1.72 [95% CI, 1.37-2.16]), discharge home (aOR, 2.19 [95% CI, 1.73-2.77]), and independence at discharge (aOR, 2.21 [95% CI, 1.66-2.95]) when onset to EVT time was ≤6 hours compared with >6 hours. The fastest decay in good outcomes per hour occurred within 6 hours of symptom onset. Among patients receiving EVT for BAO, faster treatment from symptom onset was associated with improved outcomes. These findings support efforts to achieve rapid treatment with EVT for patients with BAO.

Clinical Outcomes of Patients with Combined Idiopathic Pulmonary Fibrosis and Emphysema in the IPF-PRO Registry

PurposeTo assess the impact of concomitant emphysema on outcomes in patients with idiopathic pulmonary fibrosis (IPF).MethodsThe IPF-PRO Registry is a US registry of patients with IPF. The presence of combined pulmonary fibrosis and emphysema (CPFE) at enrollment was determined by investigators’ review of an HRCT scan. Associations between emphysema and clinical outcomes were analyzed using Cox proportional hazards models.ResultsOf 934 patients, 119 (12.7%) had CPFE. Compared with patients with IPF alone, patients with CPFE were older (median 72 vs 70 years); higher proportions were current/former smokers (88.2% vs 63.7%), used oxygen with activity (49.6% vs 31.9%) or at rest (30.8% vs 18.4%), had congestive heart failure (13.6% vs 4.8%) and had prior respiratory hospitalization (25.0% vs 16.7%); they had higher FVC (median 71.8 vs 69.4% predicted) and lower DLco (median 35.3 vs 43.6% predicted). In patients with CPFE and IPF alone, respectively, at 1 year, rates of death or lung transplant were 17.5% (95% CI: 11.7, 25.8) and 11.2% (9.2, 13.6) and rates of hospitalization were 21.6% (14.6, 29.6) and 20.6% (17.9, 23.5). There were no significant associations between emphysema and any outcome after adjustment for baseline variables. No baseline variable predicted outcomes better in IPF alone than in CPFE.ConclusionApproximately 13% of patients in the IPF-PRO Registry had CPFE. Physiologic characteristics and comorbidities of patients with CPFE differed from those of patients with IPF alone, but the presence of emphysema did not drive outcomes after adjustment for baseline covariates.Trial registrationClinicalTrials.gov, NCT01915511; registered August 5, 2013.

High Frequency of Microvascular Dysfunction in US Outpatient Clinics: A Sign of High Residual Risk? Data from 7,105 Patients.

Previous studies have linked peripheral microvascular dysfunction measured by arterial tonometry to high residual risk in on-statin patients. Digital thermal monitoring (DTM) of microvascular function is a new and simplified technique based on fingertip temperature measurements that has been correlated with the burden of atherosclerosis and its risk factors. Here, we report analyses of DTM data from two large US registries: Registry-I (6,084 cases) and Registry-II (1,021 cases) across 49 US outpatient clinics. DTM tests were performed using a VENDYS device during a 5-minute arm-cuff reactive hyperemia. Fingertip temperature falls during cuff inflation and rebounds after deflation. Adjusted maximum temperature rebound was reported as vascular reactivity index (VRI). VRI distributions were similar in both registries, with mean ± SD of 1.58 ± 0.53 in Registry-I and 1.52 ± 0.43 in Registry-II. In the combined dataset, only 18% had optimal VRI (≥2.0) and 82% were either poor (<1.0) or intermediate (1.0-2.0). Women had slightly higher VRI than men (1.62 ± 0.56 vs. 1.54 ± 0.47, p < 0.001). VRI was inversely but mildly correlated with age (r = −0.19, p < 0.001). Suboptimal VRI was found in 72% of patients <50 years, 82% of 50-70 years, and 86% of ≥70 years. Blood pressure was not correlated with VRI. In this largest registry of peripheral microvascular function measurements, suboptimal scores were highly frequent among on-treatment patients, possibly suggesting a significant residual risk. Prospective studies are warranted to validate microvascular dysfunction as an indicator of residual risk.

POSB30 Systematic Literature Review of Clinical, Economic, and Patient-Reported Benefits of Connected Insulin Pen Systems

Connected insulin pen systems may improve outcomes in insulin-treated people with diabetes (PwD), potentially reducing disease burden and improving suboptimal insulin use. Within this rapidly developing field, a systematic literature review (SLR) was conducted to summarise the current clinical, economic, and patient-reported benefits of this technology. A systematic search of Medline, Embase and Cochrane library databases (limits: randomised controlled trials [RCTs], observational studies, and economic models; publication date, 2015–2021; English-language), select conference proceedings (limits: 2018–2021), US and European clinical trial registries, and the grey literature (no limits) was performed following PRISMA guidelines. Subjects were Type 1 and 2 adult PwD. Technologies assessed included: connected insulin pens/systems, insulin smart caps/sleeves, and associated mobile applications. 1,898 publications/abstracts were identified. Following screening, 11 unique studies were retained for analysis: 6 observational studies, three RCTs and two economic studies. The small size and observational design of many studies, as well as heterogeneity of outcomes, precludes drawing firm overall conclusions. However, the emerging data show a positive trend for the impact of connected insulin pens on PwD. Specifically, use of connected technologies resulted in fewer missed bolus doses, better time in range and blood glucose levels, lower incidence of hypoglycaemia, higher patient satisfaction, and lower costs. This SLR documented that connected insulin pen systems may help to reduce suboptimal insulin dosing. Studies demonstrate that these systems may help type 1 and type 2 PwDs to relieve the burden of insulin-treatment and to reduce the number of missed bolus injections, which leads to better glycaemic control. Although evidence in this field is still in its early stages, early indications suggest that connected insulin pen systems could be increasingly considered as part of routine clinical care for insulin-treated PwD who are faced with the complexity of their daily insulin routine.

Abstract 14032: Racial Differences in Clinical Manifestations and Events in Fibromuscular Dysplasia: A Report of the United States Registry for FMD

Introduction: Fibromuscular dysplasia (FMD) is a non-inflammatory vasculopathy associated with arterial stenosis, aneurysm, dissection, and tortuosity. We investigated racial differences in clinical manifestations and events of multifocal FMD. Methods: Demographics, medical history, presenting signs and symptoms, and major vascular events were queried from the US Registry for FMD and stratified into White or Black based on self-identified race. Results: Of the 1897 female patients (pts) with multifocal FMD and race reported from 14 sites as of 12/23/2020, there were 1697 (89.5 %) White, 123 (6.5 %) Black, 52 (2.7%) Hispanic, and 25 (1.3%) pts of other races. Given a small number of pts in other groups, analysis was only performed between White and Black pts. Age at diagnosis and at first sign/symptom was similar between the two groups. Black pts were more likely to have a history of hypertension (p=0.009), stroke (p=0.002), and subarachnoid hemorrhage (p&lt;0.001) than White pts. While Black pts were less likely to have had any arterial dissection (p=0.010), a higher percentage had aortic dissection (p=0.015). Family history of FMD was less common among Black pts (p=0.018). There were differences in the distribution of vascular bed involvement and aneurysms between Black and White pts, though not all patients underwent comprehensive vascular imaging. Conclusion: We noted a low number of Black patients enrolled in the US Registry for FMD at FMD specialty centers. There were differences in clinical manifestations, events, and pattern of vascular involvement among Black and White patients enrolled in US Registry, the mechanisms for which require additional study.

Diuretic Changes, Health Care Resource Utilization, and Clinical Outcomes for Heart Failure With Reduced Ejection Fraction: From the Change the Management of Patients With Heart Failure Registry.

Diuretics are a mainstay therapy for the symptomatic treatment of heart failure. However, in contemporary US outpatient practice, the degree to which diuretic dosing changes over time and the associations with clinical outcomes and health care resource utilization are unknown. Among 3426 US outpatients with chronic heart failure with reduced ejection fraction in the Change the Management of Patients with Heart Failure registry with complete medication data and who were prescribed a loop diuretic, diuretic dose increase was defined as: (1) change to a total daily dose higher than their previous total daily dose, (2) addition of metolazone to the regimen, (3) change from furosemide to either bumetanide or torsemide, and the change persists for at least 7 days. Adjusted hazard ratios or rate ratios along with 95% CIs were reported for clinical outcomes among patients with an increase in oral diuretic dose versus no increase in diuretic dose. Overall, 796 (23%) had a diuretic dose increase (18 episodes per 100 patient-years). The proportion of patients with dyspnea at rest (38% versus 26%), dyspnea at exertion (79% versus 67%), orthopnea (32% versus 21%), edema (60% versus 43%), and weight gain (40% versus 23%) were significantly (all P <0.001) higher in the diuretic increase group. Baseline angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (hazard ratio, 0.75 [95% CI, 0.65-0.87]) use were associated with lower likelihood of diuretic increase over time. Patients with a diuretic dose increase had a significantly higher number of heart failure hospitalizations (rate ratio, 2.53 [95% CI, 2.10-3.05]), emergency department visits (rate ratio, 1.84 [95% CI, 1.56-2.17]), and home health visits (rate ratio, 1.88 [95% CI, 1.39-2.54]), but not all-cause mortality (hazard ratio, 1.10 [95% CI, 0.89-1.36]). Similarly, greater furosemide dose equivalent increases were associated with greater resource utilization but not with mortality, compared with smaller increases. In this contemporary US registry, 1 in 4 patients with heart failure with reduced ejection fraction had outpatient escalation of diuretic therapy over longitudinal follow-up, and these patients were more likely to have sign/symptoms of congestion. Outpatient diuretic dose escalation of any magnitude was associated with heart failure hospitalizations and resource utilization, but not all-cause mortality.

Crowding at hospitals- the main reason for not seeking medical care when affected by an acute myocardial infarction during the first wave of COVID-19

Abstract Background Delay in seeking treatment for AMI reduces the success rate of reperfusion therapy and affects both morbidity and mortality. During the outbreak of COVID-19 pandemic, rates of hospitalization for cardiovascular diseases has decreased nationally as well as internationally and a reduction of STEMI patients with 25–48% was reported in European and US registries. The reasons for this change in health care seeking behaviour in AMI are still unknown. Purpose To evaluate possible behavioral changes in patients seeking medical care when affected by an acute myocardial infarction during the first wave on ongoing COVID-19 pandemic. Methods This was a cross sectional study in a Region in Sweden during the first wave of the COVID-19 pandemic (March-June) with patients selected from the national registry (SWEDEHEART). Eligible were patients with AMI and totally 602 patients were invited. A self-administrated psychometric evaluated queastionnaire (PA-AMI) was sent to the patientes by post and questions regarding COVID-19 were added. PA-AMI includes 14 items regarding thoughts, feelings and actions prior to care-seeking. All items are answered on a Likert-type rating scale with six grades from 1 'do not agree at all' to 6 'totally agree'. Additionally, there were questions about age, gender, country of birth, when symptoms started and when decide to seek medical care. COVID-19 questions were 'would you have sought medical care earlier if the pandemic COVID-19 would not have existed', 'if yes, why did you not seek medical care' with follow-up questions. From SWEDEHEART the following were obtained, e.g. type of AMI, history of: AMI, diabetes and percutaneous coronary intervention (PCI), date and time of first symptoms to arrival at hospital/ward or PCI lab. Results A total of 326 patients answered the questionnaire. Of these, 17% hesitated to seek medical care due to the pandemic. Patients characteristics are shown in Table 1. These patients mainly hesitated due to a fear that the healthcare was overcrowded with patients with COVID-19, followed by a fear of becoming infected by COVID-19 at the hospital (Fig 1). Women and patients not born in SWEDEN were significant more represented in this group. The self-assessed patient delay was 22 h (median) versus 4.5 h registered in SWEDEHEART. PA-AMI displayed that symptom perception and seriousness of symptoms, unsureness where to turn and difficulties to decide seek medical care, was ssociated to those who hesitated to seek medical care due to the pandemic. Conclusions During the first wave of the COVID-19 pandemic, women and patients not born in SWEDEN, as well as patients with more than one risk factor (smoking, diabetes) had a longer delay in seeking medical care for AMI due to fear of overcrowded hospitals. Therefore, these patients should be encouraged to seek medical care and there is an importance of information about how and when to seek medical care, especially in the light of COVID-19. Funding Acknowledgement Type of funding sources: None. Table 1Figure 1

CLINICAL CHARACTERISTICS OF PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION AND TREATMENT PATTERNS: A REAL-WORLD ANALYSIS FROM SPHERE (SELEXIPAG: THE USERS DRUG REGISTRY)

CLINICAL CHARACTERISTICS OF PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION AND TREATMENT PATTERNS: A REAL-WORLD ANALYSIS FROM SPHERE (SELEXIPAG: THE USERS DRUG REGISTRY)