Large US Registry Research Articles

In-hospital outcomes of ventricular tachycardia catheter ablation in the presence of intra-cardiac thrombus

Abstract Background Ventricular tachycardia (VT) catheter ablation in the presence of intracardiac thrombi was evaluated in very few studies. Objectives To investigate in-hospital outcomes of VT ablation in the presence of an intracardiac thrombus, in a large inpatient US registry. Methods Using the National Inpatient Sample (NIS) database, patients who underwent non-elective VT catheter ablations in the US between 2016 and 2019 were identified using ICD-10 codes. Sociodemographic, clinical data, in-hospital procedures and outcomes as well as in-hospital mortality were collected. In-hospital outcomes were compared using propensity score (PS) matching analysis with a 1:3 ratio between patients with and without intracardiac thrombus. Results A weighted total of 15,725 admissions for non-elective VT ablation were included in the study, of which 190 (1.2%) had a discharge diagnosis of intracardiac thrombus. Patients with intracardiac thrombus had a higher comorbidity burden and were more likely to have ischemic cardiomyopathy and a diagnosis of cardiac aneurysm. In PS analysis, the presence of intracardiac thrombus was significantly associated with higher rates of any in-hospital complications (42.1% vs 19.3%, P<0.009), driven by higher periprocedural cerebrovascular accident and vascular injury events. In-hospital mortality rates were not significantly different between the groups. Conclusions In patients undergoing non-elective VT ablation, intracardiac thrombus was associated with higher rates of in-hospital complications, but not higher in-hospital mortality. These findings suggest that intracardiac thrombus should not contraindicate VT ablation when deemed necessary, while efforts should be made to decrease potential complications.

In-Hospital Outcomes of Ventricular Tachycardia Catheter Ablation in the Presence of Intra-Cardiac Thrombus.

Ventricular tachycardia (VT) catheter ablation in the presence of intracardiac thrombi was evaluated in very few studies. To investigate in-hospital outcomes of VT ablation in the presence of an intracardiac thrombus, in a large inpatient US registry. Using the National Inpatient Sample (NIS) database, patients who underwent non-elective VT catheter ablations in the United States between 2016 and 2019 were identified using ICD-10 codes. Sociodemographic, clinical data, in-hospital procedures, and outcomes as well as in-hospital mortality were collected. In-hospital outcomes were compared using propensity score (PS) matching analysis with a 1:3 ratio between patients with and without intracardiac thrombus. A weighted total of 15,725 admissions for non-elective VT ablation were included in the study, of which 190 (1.2%) had a discharge diagnosis of intracardiac thrombus. Patients with intracardiac thrombus had a higher comorbidity burden and were more likely to have ischemic cardiomyopathy and a diagnosis of cardiac aneurysm. In PS analysis, the presence of intracardiac thrombus was significantly associated with higher rates of any in-hospital complications (42.1%vs. 19.3%, p<0.009), driven by higher periprocedural cerebrovascular accident and vascular injury events. In-hospital mortality rates were not significantly different between the groups. In patients undergoing non-elective VT ablation, intracardiac thrombus was associated with higher rates of in-hospital complications, but not higher in-hospital mortality. These findings suggest that intracardiac thrombus should not contraindicate VT ablation when deemed necessary, while efforts should be made to decrease potential complications.

Race and Sex Differences in the Association of Bystander CPR for Cardiac Arrest.

Bystander cardiopulmonary resuscitation (CPR) is associated with higher survival for out-of-hospital cardiac arrest, but whether its association with survival differs by patients' sex and race and ethnicity is less clear. Within a large US registry, we identified 623 342 nontraumatic out-of-hospital cardiac arrests during 2013 to 2022 for this observational cohort study. Using hierarchical logistic regression, we examined whether there was a differential association between bystander CPR and survival outcomes by patients' sex and race and ethnicity, overall and by neighborhood strata. Mean age was 62.1±17.1 years, and 35.9% were women. Nearly half of patients (49.8%) were non-Hispanic White; 20.6% were non-Hispanic Black; 7.3% were Hispanic; 2.9% were Asian; and 0.4% were Native American. Overall, 58 098 (9.3%) survived to hospital discharge. Although bystander CPR was associated with higher survival in each race and ethnicity group, the association of bystander CPR compared with patients without bystander CPR in each racial and ethnic group was highest in individuals who were White (adjusted odds ratio [OR], 1.33 [95% CI, 1.30-1.37]) and Native American (adjusted OR, 1.40 [95% CI, 1.02-1.90]) and lowest in individuals who were Black (adjusted OR, 1.09 [95% CI, 1.04-1.14]; Pinteraction<0.001). The adjusted OR for bystander CPR compared with those without bystander CPR for Hispanic patients was 1.29 (95% CI, 1.20-1.139), for Asian patients, it was 1.27 (95% CI, 1.12-1.42), and for those of unknown race, it was 1.31 (95% CI, 1.25-1.36). Similarly, bystander CPR was associated with higher survival in both sexes, but its association with survival was higher in men (adjusted OR, 1.35 [95% CI, 1.31-1.38]) than women (adjusted OR, 1.15 [95% CI, 1.12-1.19]; Pinteraction<0.001). The weaker association of bystander CPR in Black individuals and women was consistent across neighborhood race and ethnicity and income strata. Similar results were observed for the outcome of survival without severe neurological deficits. Although bystander CPR was associated with higher survival in all patients, its association with survival was weakest for Black individuals and women with out-of-hospital cardiac arrest.

Prevalence of Fibromyalgia and Widespread Pain in Psoriatic Arthritis: Association With Disease Severity Assessment in a Large US Registry.

The classic conception of pain etiology in rheumatologic disease is nociceptive pain-tissue injury and inflammation signaling through peripheral and central nerve fibers. But this can be mixed with other pain etiologies, including nociplastic, which is augmented pain experience due to central sensitization. The pain of fibromyalgia (FM) is nociplastic, occurs in 10% to 30% of patients with rheumatologic disease, and its presence can influence disease severity assessment. The objective of our study was to (1) ascertain the prevalence of FM and widespread pain (WP) in the CorEvitas psoriatic arthritis (PsA) registry as assessed by the Widespread Pain Index (WPI) and Symptom Severity Scale (SSS) questionnaires; (2) characterize the demographic and clinical factors associated with FM and WP; and (3) ascertain the association of FM and WP on the Clinical Disease Activity in Psoriatic Arthritis (cDAPSA) score and other disease activity measures. PsA registry patients completing the WPI/SSS questionnaires since May 2020, at their most recent visit recorded in the registry, were analyzed. The analysis included 1,823 patients with PsA; 11.1% fulfilled the FM definition and 20.6% fulfilled the WP definition. Several factors were associated with the FM definition, including female sex, depression and/or anxiety, impaired function, increased body mass index, and increased number of comorbidities. cDAPSA, patient pain and global assessment, and tender joint count were twice as severe in patients with FM compared to those without. FM prevalence is elevated in PsA and is associated with elevated disease measures, confounding reliable disease assessment for treat-to-target goals. Identification of FM as an influential contextual factor in disease assessment is recommended.

Analysis of Pregnancy Outcomes Following Exposure to Intramuscular Interferon Beta-1a: The AVONEX® Pregnancy Exposure Registry.

There is a lack of well-controlled US studies of intramuscular (IM) interferon beta (IFNβ)-1a use in pregnant women with multiple sclerosis; however, in the European Medicines Agency region, IFNβ formulations may be considered during pregnancy if clinically needed based on data from European Union cohort registries. The AVONEX Pregnancy Exposure Registry was established to prospectively study the effects of IM IFNβ-1a on the risk of birth defects and spontaneous pregnancy loss in a US population. Pregnant women with multiple sclerosis exposed to IM IFNβ-1a within ~ 1 week of conception or during the first trimester were included. Participants were followed until there was a pregnancy outcome, live-born infants were followed until age 8-12 weeks. Data were collected on IM IFNβ-1a exposure, demographics, patient characteristics, medical history, and pregnancy outcomes, including live births (with or without birth defect), spontaneous abortions/miscarriages and fetal death/stillbirth, elective abortions (with and without birth defect), and ectopic pregnancies. A population-based birth defect surveillance program, the Metropolitan Atlanta Congenital Defects Program (MACDP), served as the primary external control group for evaluating the risk of birth defects. Three-hundred and two patients with a median (range) age of 31.0 (16-48) years and a median (range) gestational age at the time of enrollment of 10.1 (4-39) weeks were evaluable. Most patients (n = 278/302; 92%) reported IM IFNβ-1a exposure in the week before conception and most (n = 293/302; 97%) discontinued treatment before the end of the first trimester. Of 306 pregnancy outcomes, there were 272 live births, 28 spontaneous abortions of 266 pregnancies enrolled before 22 weeks' gestation (rate 10.5%; 95% confidence interval 7.2-15.0), five elective abortions, and one stillbirth. There were 17 adjudicator-confirmed major birth defects of 272 live births (rate 6.3%; 95% confidence interval 3.8-10.0); the pattern of birth defects observed was not suggestive of a relationship to prenatal IM IFNβ-1a exposure. This large US registry study suggests IM IFNβ-1a exposure during early pregnancy was not clinically associated with adverse pregnancy outcomes in women with multiple sclerosis. These findings help inform clinicians and patients in weighing the risks and benefits of IM IFNβ-1a use during pregnancy. ClinicalTrials.gov: NCT00168714, 15 September, 2005.

Rheumatoid Arthritis Disease Activity and Hospitalized Infection in a Large US Registry.

The association between disease activity and infection risk among patients with rheumatoid arthritis (RA) is not clear, and it is challenging to determine because of confounding due to the effects of RA treatments and comorbidities. Using patients with RA in the CorEvitas registry with Medicare coverage in 2006-2019, we identified eligible patients who had at least 1 visit with moderate disease activity based on the Clinical Disease Activity Index (CDAI; CDAI >10 and ≤22). Follow-up started at the subsequent CorEvitas visit. Hospitalized infection during follow-up was assessed in linked Medicare data. We calculated the incidence rate of hospitalized infection for patients in remission, and low and moderate disease activity, and estimated the effect of time-varying CDAI on hospitalized infection by controlling for baseline and time-dependent confounders using marginal structural models (MSMs). A total of 3,254 patients with RA were eligible for analysis, among which 529 hospitalized infections were identified during follow-up. The crude incidence of hospitalized infection was 3.8 per 100 person-years for patients in remission, 6.6 for low disease activity, and 8.0 for moderate disease activity. Using MSMs and compared with being in remission, the hazard ratio of hospitalized infection associated with low disease activity was 1.60 (95% confidence interval [95% CI] 1.13-2.28) and with moderate disease activity was 1.83 (95% CI 1.30-2.64). The risk of hospitalized infection was higher for patients with RA in low or moderate disease activity than for those in remission after accounting for the interplay of disease activity, RA treatments, treatment switching, and other potential confounders.

Development and Validation of a Simulation Model-Based Clinical Decision Tool: Identifying Patients Where 21-Gene Recurrence Score Testing May Change Decisions.

PURPOSEThere is a need for industry-independent decision tools that integrate clinicopathologic features, comorbidities, and genomic information for women with node-negative, invasive, hormone receptor–positive, human epidermal growth factor receptor-2–negative (early-stage) breast cancer.METHODSWe adapted an extant Cancer Intervention and Surveillance Modeling Network simulation model to estimate the 10-year risk of distant recurrence, breast cancer–specific mortality, other-cause mortality, and life-years gained with chemoendocrine versus endocrine therapy. We simulated outcomes for 1,512 unique patient subgroups based on all possible combinations of age, tumor size, grade, and comorbidity level; simulations were performed with and without 21-gene recurrence scores (RSs). Model inputs were derived from clinical trials, large US cohort studies, registry, and claims data. External validation was performed by comparing results to observed rates in two independent sources. We highlight results for one scenario where treatment choice may be uncertain.RESULTSChemoendocrine versus endocrine therapy in a 65-69-year-old woman with a small (≤ 2 cm), intermediate-grade tumor, and mild comorbidities provides a 1.3% absolute reduction in 10-year distant recurrence risk, with 0.23 life-years gained. With these tumor features, a woman like this will have a 28% probability of having an RS 16-20, 18% RS 21-25, and 11% RS 26+. If testing is done, and her RS is 16-20, chemoendocrine therapy reduces 10-year distant recurrence risk to 1%, with 0.20 life-years gained, a similar result as without testing. The absolute benefits would increase to 4.8%-5.5% if the RS was 26+. The model closely reproduced observed rates in both independent data sets.CONCLUSIONOur validated clinical decision tool is flexible, readily adaptable to include new therapies, and can support discussions about genomic testing and early breast cancer treatment.

OP0101 RHEUMATOID ARTHRITIS DISEASE ACTIVITY OVER TIME AND SUBSEQUENT CARDIOVASCULAR RISKS.

Background:Rheumatoid arthritis (RA) patients have an increased risk of cardiovascular (CV) events not fully explained by traditional CV risk factors. The relationship between fluctuating inflammation due to RA disease activity and CV events is of interest.Objectives:To examine the influence of time-varying disease activity on the subsequent risks of CV disease.Methods:We followed patients from a large US registry of clinically diagnosed RA patients, starting at their first visit with a Clinical Disease Activity Index (CDAI) through the end of follow-up or first CV event. Exposure of interest was disease activity measured by categorical CDAI (high, moderate, low, and remission) averaged within each 6-month window. The outcome of interest was major adverse CV events (MACE) defined as non-fatal myocardial infarction, non-fatal stroke (excluding transient ischemic attacks), and CV death. For baseline confounders we considered age, gender, race, disease duration, Health Assessment Questionnaire, hypertension, diabetes, hyperlipidemia, family history of premature (age&lt;50) CV events, and RF/ACPA seropositivity. For time-varying variables we considered tumor necrosis factor inhibitor (TNFi), non-TNFi biologic, methotrexate, oral glucocorticoid, non-steroidal anti-inflammatory drugs, statin, and aspirin use. We used the marginal structural model (MSM) framework to examine the impact of CDAI at each 6-month interval on MACE. We estimated time-varying hazard ratios (HRs) comparing high CDAI during follow-up to CDAI remission. Several predicted survival curves were constructed under different hypothetical CDAI scenarios, such as early and late transition to CDAI remission.Results:40,721 patients were eligible for our analyses. 77% were female and 84% were Caucasian. The mean age was 58 (SD 13) years with mean disease duration of 8.8 (median 5) years. Mean CDAI at their first registry visit was 14 (SD 13; remission 19%, low 31%, moderate 28%, and high 22%). Other baseline characteristics include: 41% current/former smokers, 31.5% with hypertension, 8.6% with diabetes, 18% with hyperlipidemia, and 52% seropositive. The average follow-up duration after baseline was 4.4 (median 3.3; max. 17.6) years. The crude event count of MACE was 1,050 events / 180,402 person-years.In the MSM analysis, the average HRs, assuming a constant HR, were 1.31 [0.90, 1.90] for low, 1.46 [1.01, 2.10] for moderate, and 1.43 [0.89, 2.31] for high CDAI disease activity categories during each 6-month interval. When approximating time-varying HR with linear trends, the highest estimates during the first 6 months of follow up were 1.61 [0.93, 2.77] for low CDAI, 1.97 [1.13, 3.43] for moderate CDAI, and 2.11 [1.13, 3.96] for high CDAI. These HRs gradually diminished during the follow up (Table). When we constructed hypothetical survival curves with transition to CDAI remission at different time points, earlier transition to CDAI remission was related to better event-free survival (Figure).Table 1.Time-varying hazard ratio estimates [95% confidence intervals] by duration in studyDisease activity measured by CDAIYearRemissionLowModerateHigh0.51.00 [ref]1.61 [0.93, 2.77]1.97 [1.13, 3.43]2.11 [1.13, 3.96]11.00 [ref]1.54 [0.97, 2.44]1.85 [1.17, 2.93]1.94 [1.13, 3.31]21.00 [ref]1.42 [1.00, 2.01]1.63 [1.16, 2.29]1.62 [1.04, 2.54]31.00 [ref]1.31 [0.90, 1.90]1.43 [0.97, 2.11]1.36 [0.80, 2.31]41.00 [ref]1.20 [0.72, 2.02]1.26 [0.72, 2.21]1.14 [0.55, 2.36]51.00 [ref]1.11 [0.54, 2.26]1.11 [0.51, 2.42]0.96 [0.36, 2.53]Figure 1.MACE-free survival curves under hypothetical CDAI scenariosConclusion:High and moderate CDAI were associated with higher hazard of MACE during the earlier period of follow-up, but the increased hazard diminished over time. In hypothetical senarios, earlier transition to CDAI remission would improve MACE free-survival.Acknowledgements:This study was sponsored by Corrona, LLC. Corrona is supported through contracted subscriptions with multiple pharmaceutical companies. The analysis was financially supported by Amgen Inc.Disclosure of Interests:Kazuki Yoshida Consultant of: OM1, Inc., Grant/research support from: Corrona, LLC., Hongshu Guan: None declared, Scott Stryker Shareholder of: Amgen, Inc., Employee of: Amgen, Inc., Elaine Karis Shareholder of: Amgen, Inc., Employee of: Amgen, Inc., Leslie Harrold Consultant of: AbbVie, Bristol-Myers Squibb, Genentech/Roche, Grant/research support from: Pfizer, Daniel Solomon Grant/research support from: DHS receives salary support from research contracts through Brigham and Women’s Hospital with Abbvie, Amgen, Corrona, Genentech and Janssen.

Real-World Application of a Noninvasive Two-Gene Expression Test for Melanoma Diagnosis

A two-gene noninvasive molecular test (pigmented lesion assay [PLA], DermTech, La Jolla, CA) for the diagnosis of melanoma is commercially available in the United States. The test measures gene expression for LINC00518 and PRAME from stratum corneum samples ( Gerami et al., 2017 Gerami P. Yao Z. Polsky D. Jansen B. Busam K. Ho J. et al. Development and validation of a noninvasive 2-gene molecular assay for cutaneous melanoma. J Am Acad Dermatol. 2017; 76: 114-120.e2 Abstract Full Text Full Text PDF PubMed Scopus (57) Google Scholar ). However, the 2017 validation study and 2018 registry study provided different estimates of the test’s diagnostic accuracy (sensitivity of 91–95% and specificity of 53–91%) ( Ferris et al., 2018 Ferris L.K. Gerami P. Skelsey M.K. Peck G. Hren C. Gorman C. et al. Real-world performance and utility of a noninvasive gene expression assay to evaluate melanoma risk in pigmented lesions. Melanoma Res. 2018; 28: 478-482 Crossref PubMed Scopus (31) Google Scholar ; Gerami et al., 2017 Gerami P. Yao Z. Polsky D. Jansen B. Busam K. Ho J. et al. Development and validation of a noninvasive 2-gene molecular assay for cutaneous melanoma. J Am Acad Dermatol. 2017; 76: 114-120.e2 Abstract Full Text Full Text PDF PubMed Scopus (57) Google Scholar ). The factors that contribute to different estimates of the PLA’s diagnostic accuracy are not well characterized, which has raised concerns about its validity and potential for harm ( Beatson and Weinstock, 2019 Beatson M. Weinstock M.A. Further consideration of the pigmented lesion assay. JAMA Dermatol. 2019; 155: 393 Crossref PubMed Scopus (2) Google Scholar ). In this study, we used 2020 registry data ( Brouha et al., 2020 Brouha B. Ferris L.K. Skelsey M.K. Peck G. Moy R. Yao Z. et al. Real-world utility of a non-invasive gene expression test to rule out primary cutaneous melanoma: a large US registry study. J Drugs Dermatol. 2020; 19: 257-262 Crossref PubMed Google Scholar ) to model the real-world application and utility of the PLA.

Utilization and survival outcomes between definitive versus conservative treatments among elderly men with high-risk prostate cancer.

204 Background: Prostate cancer (PCa) is the second leading cause of cancer death in men &gt; 80 years old. However, studies have shown that older men are less likely to undergo curative treatment for localized PCa, possibly due to competing comorbidities or inability to accurately estimate life expectancy. Herein, we investigate utilization trends and survival outcomes amongst guideline-supported treatment options in elderly men with high-risk PCa in the United States. Methods: Men ≥ 80 years diagnosed with high-risk PCa (cT3-4 or Gleason 8-10 or PSA &gt; 20) between 2004-2016 were analyzed from the National Cancer Database. Those missing risk-stratification or treatment data were excluded. Eligible patients were grouped based on their primary treatment modality: no treatment (observation), androgen deprivation therapy (ADT) alone, radiation therapy (RT) alone, RT + ADT, or radical prostatectomy (RP). Cochran-Armitage was used to evaluate treatment trends over time, and multivariable logistic regression was used to identify sociodemographic predictors of treatment. Overall survival (OS) between treatments was evaluated using Kaplan-Meier, log-rank, and multivariable Cox proportional hazards. Results: With a median follow up of 42 months, 19,920 men were eligible for analysis. The most utilized treatment modality was RT+ADT (37.2%), followed by ADT alone (29.4%), observation (23.9%), RT alone (7.8%), and RP (1.7%). There was a significant increase in use of RT+ADT and RT alone (p &lt; 0.001) and decrease in use of ADT alone and observation ( p&lt; 0.001); no change was seen in RP use. There was no OS difference between observation versus ADT alone (aHR 1.04, 95% CI 0.99-1.09, p = 0.11). Definitive local treatment was associated with improved OS compared to ADT alone (RT+ADT: aHR 0.48, 95% CI 0.46-0.50, p &lt; 0.0001; RT alone: aHR 0.54, 95% CI 0.50-0.59, p &lt; 0.0001; RP: aHR 0.50, 95% CI 0.42-0.59, p &lt; 0.0001). Black men and uninsured status were independently associated with lower likelihood of undergoing definitive treatment (i.e. RT+ADT, RT, or RP). Conclusions: For men ≥ 80 years old with high-risk PCa in this large US registry, definitive local therapy using RT +/- ADT or RP was associated with a 50% reduction in overall mortality compared to observation or ADT alone. Less than half of men in this time period underwent a definitive treatment, and Black and uninsured men remained at particularly high risk of undertreatment.

15335 Real-world utility of a noninvasive gene expression test to rule out primary cutaneous melanoma: A large US registry study

The Pigmented Lesion Assay (PLA) analyzes gene expression to objectively rule out melanoma. The test uses a noninvasive adhesive patch-based sample collection platform that enables guidance on biopsy decisions and elevates pigmented lesion management beyond what can be visually ascertained. The test’s negative predictive value of 99%, and rapid, painless application make it an attractive pre-biopsy solution. It reduces biopsies by 90% while improving care and reducing cost. This registry study (53 US dermatology offices, 90 providers, median patient age 48 years, 60.80% female patients) assesses real-world utility to determine if the PLA changes clinical practice. The PLA assessed 3418 concerning pigmented skin lesions. Three hundred twenty-four lesions (9.48%) were PLA(+) and 3094 (90.52%) were negative. A PLA test result is positive if LINC, PRAME, or both target genes are detected. These molecular pathology findings are known to correspond with histopathology findings of in situ or invasive primary melanoma in 7%, 50%, and 93%, respectively. The 9.48% PLA(+) cases consisted of 5.15% LINC-only, 1.93% PRAME-only, and 2.40% LINC and PRAME double positive cases. Notably, PLA(+) lesions were almost universally surgically biopsied (97.53%), while PLA(−) cases were nearly always monitored and not biopsied (99.94%). These studies demonstrate that the PLA has true clinical value in community-based practices where providers make important decisions based on the test’s results. Pigmented lesions with PLA(+) test results are subjected to surgical biopsies, whereas PLA(−) lesions are followed clinically and not biopsied.

Outcomes for Out-of-Hospital Cardiac Arrest in the United States During the Coronavirus Disease 2019 Pandemic

Recent reports from communities severely affected by the coronavirus disease 2019 (COVID-19) pandemic found lower rates of sustained return of spontaneous circulation (ROSC) for out-of-hospital cardiac arrest (OHCA). Whether the pandemic has affected OHCA outcomes more broadly is unknown. To assess the association between the COVID-19 pandemic and OHCA outcomes, including in areas with low and moderate COVID-19 disease burden. This study used a large US registry of OHCAs to compare outcomes during the pandemic period of March 16 through April 30, 2020, with those from March 16 through April 30, 2019. Cases were geocoded to US counties, and the COVID-19 mortality rate in each county was categorized as very low (0-25 per million residents), low (26-100 per million residents), moderate (101-250 per million residents), high (251-500 per million residents), or very high (>500 per million residents). As additional controls, the study compared OHCA outcomes during the prepandemic period (January through February) and peripandemic period (March 1 through 15). The COVID-19 pandemic. Sustained ROSC (≥20 minutes), survival to discharge, and OHCA incidence. A total of 19 303 OHCAs occurred from March 16 through April 30 in both years, with 9863 cases in 2020 (mean [SD] age, 62.6 [19.3] years; 6040 men [61.3%]) and 9440 in 2019 (mean [SD] age, 62.2 [19.2] years; 5922 men [62.7%]). During the pandemic, rates of sustained ROSC were lower than in 2019 (23.0% vs 29.8%; adjusted rate ratio, 0.82 [95% CI, 0.78-0.87]; P < .001). Sustained ROSC rates were lower by between 21% (286 of 1429 [20.0%] in 2020 vs 305 of 1130 [27.0%] in 2019; adjusted RR, 0.79 [95% CI, 0.65-0.97]) and 33% (149 of 863 [17.3%] in 2020 vs 192 of 667 [28.8%] in 2019; adjusted RR, 0.67 [95% CI, 0.56-0.80]) in communities with high or very high COVID-19 mortality, respectively; however, rates of sustained ROSC were also lower by 11% (583 of 2317 [25.2%] in 2020 vs 740 of 2549 [29.0%] in 2019; adjusted RR, 0.89 [95% CI, 0.81-0.98]) to 15% (889 of 3495 [25.4%] in 2020 vs 1109 of 3532 [31.4%] in 2019; adjusted RR, 0.85 [95% CI, 0.78-0.93]) in communities with very low and low COVID-19 mortality. Among emergency medical services agencies with complete data on hospital survival (7085 total patients), survival to discharge was lower during the pandemic compared with 2019 (6.6% vs 9.8%; adjusted RR, 0.83 [95% CI, 0.69-1.00]; P = .048), primarily in communities with moderate to very high COVID-19 mortality (interaction P = .049). Incidence of OHCA was higher than in 2019, but the increase was largely observed in communities with high COVID-19 mortality (adjusted mean difference, 38.6 [95% CI, 37.1-40.1] per million residents) and very high COVID-19 mortality (adjusted mean difference, 28.7 [95% CI, 26.7-30.6] per million residents). In contrast, there was no difference in rates of sustained ROSC or survival to discharge during the prepandemic and peripandemic periods in 2020 vs 2019. Early during the pandemic, rates of sustained ROSC for OHCA were lower throughout the US, even in communities with low COVID-19 mortality rates. Overall survival was lower, primarily in communities with moderate or high COVID-19 mortality.

P1641DONOR ACUTE KIDNEY INJURY HAS A DELETERIOUS IMPACT ON KIDNEY GRAFT SURVIVAL: THE DON-AKI STUDY

Abstract Background and Aims Acute kidney injury (AKI) during organ procurement represents an important cause of discarded kidneys. In the context of organ shortage, the evaluation of such grafts is needed in order to enlarge the donor pool. Although many studies showed an increased risk of delayed graft function when donors present with AKI, long-term impact on graft survival remains controversial. A recent large US registry study concluded that AKI during organ procurement had no deleterious effect on graft survival. However the definition of AKI in this latter study is questionable. Indeed the donor baseline serum creatinine (SCr), according to KDIGO recommendations, is often not available. In this situation, the KDIGO guidelines suggest to estimate the baseline SCr using the MDRD equation, assuming a baseline glomerular filtration rate at 75 mL/min/1.73m? This method was applied in the present study to assess the impact of donor kidney failure on long term kidney allograft survival. Method We analyzed the French national allocation system CRISTAL (Agence de la Biomédecine) data of all the recipients who received a deceased donor kidney graft from 2006 to 2017. 26786 transplant patients from 14899 deceased kidney donors were included. The donors were categorized into four groups. Ongoing AKI at the time of kidney procurement: n=1880 (3373 transplantations, AKI group), AKI with total recovery (normal SCr) at the time of kidney procurement: n=1332 donors (2392 transplantations, recovery group), elevated SCr all along the procedure: n=952 donors (1745 transplantations, unclassified AKI/CKD group) and normal SCr all along the procedure: n=10735 donors (19276 transplantations, no-AKI group). The main outcome was death censored graft survival. Results 4458 graft losses occurred during the study period (648 in the AKI group, 411 in the recovery group, 297 in the unclassified AKI/CKD group and 3102 in the no-AKI group) after a median follow-up time of 5.7 years (3 - 8.9). Multivariate analysis showed a significant increase risk of graft loss for each group when compared to the no-AKI group: HR 1.18 (1.04-1.34), HR 1.15 (1.04-1.28) and HR 1.22 (1.12-1.34) for the unclassified AKI/CKD, recovery and AKI groups, respectively. Regarding the AKI group, the risk of graft loss increased according to the AKI stage (KDIGO 2012): HR 1.20 (1.08-1.32) for stage I AKI and HR 1.31 (1.13-1.53) for stage II-III AKI. Conclusion Donor AKI represents a significant risk factor of graft loss, independently of SCr at the time of procurement. Stage II-III AKI carries a higher risk than stage I AKI suggesting a “dose-effect”. However, considering organ shortage, further studies are required to better allocate these sub-optimal kidneys.

Disease activity and patient-reported outcomes in patients with rheumatoid arthritis and Sj\xf6gren\u2019s syndrome enrolled in a large observational US registry

The objective of this study was to compare rheumatoid arthritis (RA) disease activity and patient-reported outcomes (PROs) in a national sample of patients with RA with/without Sjögren’s syndrome (SS). Adults with RA from a large observational US registry (Corrona RA) with known SS status between 22 April 2010 and 31 July 2018 and a visit 12 (± 3) months after index date were identified (n = 36,256/52,757). SS status: determined from a yes/no variable reported at enrolment into the Corrona RA registry and follow-up visits. Index date: date that SS status was recorded (yes/no). Patients received biologic or targeted synthetic disease-modifying antirheumatic drugs as part of standard care. Patients with RA only were followed for ≥ 12 months to confirm the absence of SS. Patients were frequency- and propensity-score matched (PSM) 1:1 and stratified by disease duration and treatment response-associated variables, respectively. Clinical Disease Activity Index (CDAI) and PROs 12 months after index visit were compared in patients with and without SS. Baseline characteristics in 283 pairs of PSM patients were balanced. Mean change in CDAI score was numerically lower in patients with RA and SS than patients with RA only (8.8 vs 9.3). Reductions in PROs of pain, fatigue and stiffness were two- to threefold lower for patients with RA and SS versus RA only. Reductions in RA disease activity and RA-related PROs were lower in patients with RA and SS versus those with RA only. Our data indicate that SS adds to treatment challenges; physicians may wish to consider SS status when managing patients with RA.

Abstract P249: Association Between Cardiovascular Event Type And Smoking Cessation Rates Among Outpatients With Atherosclerotic Cardiovascular Disease: Insights From The Ncdr Pinnacle Registry

Introduction: Understanding the factors that drive cessation may help inform patient counseling and improve quit rates. We aimed to determine if the type of atherosclerotic cardiovascular disease (ASCVD) event impacts the patient’s likelihood of quitting, independent of patient factors. Hypothesis: We assessed the hypothesis that more impactful ASCVD events would be associated with a greater likelihood of smoking cessation (e.g., more likely to quit after CABG vs PCI). Methods: Using 2013-2016 data from the NCDR PINNACLE outpatient cardiac registry, we identified patients who were current smokers and had an eventual diagnosis of ASCVD. Self-reported smoking status was assessed at each consecutive visit and rates of smoking cessation after each interim ASCVD event (MI, PCI, CABG, stroke/TIA, and PAD diagnosis) were examined. We then constructed separate Cox models with non-proportional hazards for interim ASCVD events (time-dependent covariates), adjusting for age, sex, race, dyslipidemia, diabetes, hypertension, and heart failure; and compared models using AIC. Results: Across 358 cardiology practices, 378478 patients were smokers who eventually had ASCVD (mean age 65.8±11.9, male 63.6%). Cessation rates after each ASCVD event were: MI 30.5%, PCI 30.7%, CABG 28.5%, stroke/TIA 24.7%, and PAD 24.6% (Table). After multivariable adjustment, patients were more likely to quit smoking after a stroke/TIA (HR 2.46, 95% CI 2.40-2.52) followed by CABG (HR 2.45, 95% CI 2.37-2.53), PCI (HR 1.85, 95% CI 1.79-1.91), MI (HR 1.79, 95% CI 1.72-1.86), and a new diagnosis of PAD (HR 1.47, 95% CI 1.42-1.51); p&lt;0.0001 for all events. Conclusion: In a large US registry, we found that only ~25-30% of patients reported quitting smoking after an ASCVD event, but the type of ASCVD event significantly impacts the likelihood of smoking cessation. Using these data to inform patient counseling—targeting cessation efforts to those most likely to quit—may help improve outcomes.

Real-World Utility of a Non-Invasive Gene Expression Test to Rule Out Primary Cutaneous Melanoma: A Large US Registry Study

Real-World Utility of a Non-Invasive Gene Expression Test to Rule Out Primary Cutaneous Melanoma: A Large US Registry Study

A Chronobiological Evaluation of the Acute Effects of Daylight Saving Time on Traffic Accident Risk.

There is evidence that the spring Daylight Saving Time (DST) transition acutely increases motor vehicle accident (MVA) risk ("DST effect"), which has been partly attributed to sleep deprivation and circadian misalignment [1-6]. Because spring DST also shifts clock time 1h later, mornings are darker and evenings brighter, changing illumination conditions for peak traffic density. This daytime-dependent illumination change ("time of day effect") is hypothesized to result in DST-associated afternoon and evening accident risk reductions [2, 5, 7]. Furthermore, sunrise and local photoperiod timing depend on position in time zone. The sun rises at an earlier clock time in the eastern regions of a given time zone than in the western regions, which is thought to induce higher levels of circadian misalignment in the west than in the east ("time zone effect") [8, 9]. This study evaluated the acute consequences of the DST transition on MVAs in a chronobiological context, quantifying DST, time of day, and time zone effects. We used large US registry data, including 732,835 fatal MVAs recorded across all states (1996-2017), and observed that spring DST significantly increased fatal MVA risk by 6%, which was more pronounced in the morning and in locations further west within a time zone. DST-associated MVA risk increased even in the afternoon hours, despite longer daylight hours. The MVA risk increase waned in the week subsequent to DST, and there were no effects of the fall-back transition to Standard Time (ST) on MVA risk, further supporting the hypothesis that DST-transition-associated, preventable circadian misalignment and sleep deprivation might underlie MVA risk increases.

Findings from a large US registry study to assess the real-world utility of a non-invasive gene expression test designed to rule out primary cutaneous melanoma

Abstract not available.

Continuous Outpatient Intravenous Inotrope Therapy: Milrinone is Associated with Improved Survival Compared to Dobutamine Irrespective of Indication

Introduction Continuous outpatient intravenous inotrope therapy (COIIT) is a treatment strategy used in stage D heart failure as a bridge to advanced therapies [bridge-to-decision (BTD); bridge-to-mechanical support (BTMS); bridge-to-transplant (BTT)] or as palliation (PAL). Long-term survival associated with COIIT in the modern era of guideline directed medical and device therapy (GDMDT) is poorly defined. Our objective is to describe the survival of patients undergoing COIIT with milrinone or dobutamine in the modern era. Hypothesis In patients undergoing COIIT for various indications, milrinone - which allows for more effective neurohormonal antagonism with beta blockade - has a more favorable survival profile than dobutamine. Methods We retrospectively analyzed data from a large US registry of patients receiving COIIT (milrinone or dobutamine) from 2015-17. Patients with incomplete data or Results Of 1,149 patients on COIIT (mean age 60 years, 29.9% female), 260 (22.6%) patients died during the study period. Mortality was higher in patients undergoing COIIT for palliation than for bridge therapy (1-year survival: 55.0% vs 65.6%, p Conclusions In the largest data set reported to date of patients receiving COITT in the current era of GDMDT, milrinone use was associated with improved survival compared to dobutamine. A randomized, controlled trial in this growing patient population is warranted.

Improved Survival on Palliative Home Inotropes in the Modern Era

Introduction Continuous outpatient intravenous inotrope therapy (COIIT) is a treatment strategy in stage D heart failure as bridge to advanced therapies or palliation. Studies conducted before the era of modern guideline directed medical and device therapy (GDMDT) have demonstrated poor outcomes for palliative COIIT, with survival rates as low as 25% at 1 year. Our objective is to describe the outcomes of patients receiving palliative COIIT in the current era of GDMDT. Hypothesis Overall survival on palliative COIIT has improved in the era of GDMDT. The choice of inotrope (milrinone or dobutamine) has an impact on survival. Methods We retrospectively analyzed data from a large US registry of patients receiving COIIT (milrinone or dobutamine) from 2015-17. Patients were included if the indication for COIIT was palliation and excluded if they had incomplete data or Results Of 1,149 registry patients receiving COIIT, the indication was palliation in 404 (35%). The mean age was 65 years, and 30% were women. During the study period, 124 (31%) patients died. Estimated survival at 1 and 2 years was 55% and 42% respectively (Figure Panel A). Milrinone was used in 235 (58%) patients and dobutamine in 169 (42%). Compared to patients treated with dobutamine, patients treated with milrinone had greater survival at 1 year (63% vs 43%, p=0.0003) and 2 years (47% vs 34%, p=0.0003). Median survival was estimated at 699 days for milrinone and 247 days for dobutamine (Figure Panel B). The use of high-dose milrinone (≥0.375 mcg/kg/min) was associated with greater survival than either low-dose milrinone or low- or high-dose dobutamine (Figure Panel C). Conclusion Survival on palliative COIIT appears to be higher than previously reported, and milrinone use was associated with better survival than dobutamine. Prospective studies of palliative COIIT are urgently needed.