bluuebunny/crossref_metadata_2025 huggingface dataset:
Abstract 314: Impact of Spontaneous Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF-TIMI 48 Trial
Authors: Magnuson Elizabeth A , Wang Kaijun , Li Haiyan , Kwong Winghan J , Antman Elliott M , Ruff Christian T , Murphy Sabina A , Giugliano Robert P , Cohen David J
Published: July 2021

BACKGROUND:
Anticoagulation in AF patients involves consideration of the benefit of stroke risk reduction versus increased bleeding risk. The impact of bleeding events on health state utility has not been clearly understood.

METHODS:
We used prospectively-collected data from the ENGAGE AF-TIMI 48 Trial to estimate the impact of different bleeding events on utility scores derived from the EQ-5D. EQ-5D data were collected at randomization and 3 month intervals for up to 48 months; at least two EQ-5D assessments were available for 15,618 participants. Spontaneous bleeding events were identified prospectively and adjudicated according to prespecified criteria. Patients who experienced a bleed and provided at least one EQ-5D assessment before and after the event were included in the analysis. To maximize specificity, patients were excluded if they had more than 1 bleeding event or any other major cardiovascular events in addition to bleeding. Longitudinal growth curve models were used to estimate changes in utilities after the following mutually exclusive bleeding event categories: intracranial hemorrhage (ICH; n=25); major GI (n=294); major non-GI (n=236); clinically relevant non-major (CRNM) (n=1,414); and minor (n=783).

RESULTS:
There were reductions in EQ-5D utility after the event for all categories of bleeding that were in parallel with the severity of bleeding (Table). The estimated decrease in utility was greatest for ICH (-0.079), followed by major non-GI (–0.045), GI (–0.030) and CRNM (–0.009). In addition, a significant linear improvement over time was observed for major non-GI bleeds (and a similar albeit non significant improvement for major GI bleeds) such that EQ-5D scores returned to near pre-event levels one year after the bleeding event. No post-event improvement was observed for ICH, CRNM and minor bleeds, however.

CONCLUSION:
Spontaneous bleeding events are associated with a negative impact on health state utility, with greatest immediate impact for major bleeds. Health state utility remains low 1 year after an ICH, but gradually returns to baseline 1-year after other major bleeding events. Future cost-effectiveness analysis of strategies to prevent stroke in AF should consider both the economic and health status impact of bleeding events to inform health care decision making.
Abstract 320: Healthcare Resource Utilization Among Patients with Acute Coronary Syndrome Managed with Percutaneous Coronary Intervention and Using Prasugrel or Ticagrelor: A Retrospective Database Analysis
Authors: Molife Cliff , Effron Mark B , DeKoven Mitch , Karkare Swapna , Frech-Tamas Feride , Larmore Cynthia , Zhu Yajun , Lu Jingsong , Lee Won C , Mc Collam Patrick , Marrett Elizabeth , Vetrovec George W
Published: July 2021

Objective:
To show that prasugrel (pras) was non-inferior to ticagrelor (ticag) in terms of healthcare resource utilization (HCRU) based upon 30- and 90-day all-cause rehospitalization rates among patients (pts) with acute coronary syndrome (ACS) managed with percutaneous coronary intervention (PCI).

Methods:
This retrospective study used anonymized hospital data from the IMS Patient-Centric Data Warehouse to identify ACS-PCI pts aged ≥18 years with ≥1 in-hospital claim for pras or ticag between 8/1/11-4/30/13. Three cohorts were predefined and analyzed: ACS-PCI (primary cohort), ACS-PCI without prior TIA or stroke (label cohort), and ACS-PCI pts without prior TIA or stroke and if age ≥75 years required evidence of diabetes or prior MI (core cohort). The McNemar’s test was used to evaluate adjusted outcome differences between propensity matched (PM) groups. P-value for non-inferiority (p-NI) test was obtained through a one-sided Z test by comparing log (RR) with log(1.2), a predefined margin.

Results:
Among 16,098 eligible pts, 13,134 (82%) received pras and 2,964 (18%) received ticag. Compared to ticag pts, pras pts were younger, more likely men, and less likely to have cardiovascular or bleeding risk factors (P<0.05). Of the total population, 1,375 (8.54%) and 2,374 (14.75%) were rehospitalized for any reason within 30 and 90 days post discharge, respectively. After PM adjustment, pras was non-inferior to ticag for 30- and 90-day all-cause rehospitalization rates in all 3 cohorts (p-NI < 0.01). Data are summarized in Table 1. All-cause rehospitalization for the label and core cohorts showed non-inferiority and a significantly lower 90-day rehospitalization rate with pras compared with ticag (Table).

Conclusions:
All-cause rehospitalizations at 30-and 90-days post discharge in ACS-PCI pts were non-inferior with pras vs. ticag in all 3 cohorts. Pras was associated with significantly lower risk for 90-day all-cause rehospitalizations compared with ticag in the label and core cohorts, which are the majority of pts receiving pras. Although there appears to be inherent bias and unmeasured confounders related to use of pras vs. ticag, these data show reductions in HCRU with pras compared with ticag in the real-world setting at 30- and 90-days post-discharge.
Abstract 342: Impact Of System And Physician Factors On The Diagnostic Yield Of Coronary Angiography In Stable Ischemic Heart Disease: A Population Based Study
Authors: Wijeysundera Harindra C , Qiu Feng , Bennell Maria C , Natarajan Madhu K , Cantor Warren J , Smith Stuart , Kingsbury Kori J , Ko Dennis T
Published: July 2021

Background:
Wide variation exists in the diagnostic yield of coronary angiography in stable ischemic heart disease (IHD). Previous work has primarily focused on patient factors for this variation. We sought to understand if system and physician factors, specifically hospital and physician type, as well as physician self-referral, have incremental impacts on the yield of coronary angiography, above and beyond that of patient factors alone.

Methods:
All patients who underwent a diagnostic coronary angiogram for possible stable IHD, at the 18 cardiac centers in Ontario, Canada were identified from October 1st, 2008 to September 30th, 2011. Obstructive coronary artery disease was defined as stenosis greater than 70% in the main coronary arteries or greater than 50% in the left main artery. Physicians were classified as either invasive or interventional. Hospitals were categorized into cath only, stand-alone PCI and full service centers. Multi-variable hierarchical logistic models were developed to identify system and physician level predictors of obstructive coronary artery disease, having adjusted for patient factors.

Results:
Our cohort consisted of 60,986 patients who underwent a diagnostic angiogram for possible stable IHD, of which 33,483 had obstructive coronary artery disease (54.9%), ranging from 41.0% to 70.2% across centers. Self-referral rates varied from 4.8% to 74.6%. Fewer self-referral patients (52.5%) had obstructive coronary artery disease compared to non-self-referral patients (56.5%), with an odds ratio (OR) of 0.89 (95% CI 0.85-0.93;p <0.001), after accounting for patient factors. Angiograms performed by interventional physicians had a higher likelihood of showing obstructive coronary artery disease (60.1% vs. 50.8%; OR 1.22; 95% CI 1.17-1.28; p<0.001). Fewer angiograms at cath only centers showed obstructive disease (45.0%) compared to full service centers (58.1%); this was of borderline significance (OR 0.59; 95% CI 0.34-1.00; p=0.05).

Conclusion:
Physician and system factors are important predictors of the diagnostic yield of coronary angiography in stable IHD, even after accounting for patient characteristics. Further study into the drivers of how these physician and system factors impact diagnostic yield is an important focus for quality improvement.
Abstract 356: Hypertension Management at the University of Michigan Student Run Free Clinic: Does it Meet National Guidelines?
Authors: Gakenheimer Lindsey , Conjeevaram Hari S
Published: July 2021

Purpose:
The University of Michigan Student Run Free Clinic (UMSRFC) provides primary care to uninsured adults in Southeast Michigan. Optimal management of chronic conditions, such as hypertension, is one of the clinic’s primary goals. Our aim was to evaluate UMSRFC’s success in meeting the Centers of Medicare and Medicaid Service’s (CMS’s) goal of blood pressure (BP) within the recommended values for ≥63% of clinic patients diagnosed with hypertension.

Methods:
A retrospective chart review identified hypertensive patients with at least two UMSRFC visits between April 2012 and July 2013. Age, sex, ethnicity, body mass index, medications, blood pressure (BP), and comorbidities were extracted and stored in an online database. Patients were separated into two groups: those with controlled hypertension (≤140/90 mmHg for systolic/diastolic BP) at their most recent clinic date and those with uncontrolled hypertension (>140/90 mmHg for systolic/diastolic BP) at the most recent clinic visit.

Results:
Of 43 patients presenting with hypertension, 26 (60.5%) met inclusion criteria. The average age was 52.3 +/- 2.0 years, and 12 (46.2%) were male. The majority (17, 65.4%) of patients self-identified as Caucasian, and 24 (92.4%) were from Southeast Michigan. Follow-up BP was controlled for 17 (65.4%) patients. All 6 (23.1%) patients controlled at initial visit remained controlled at follow-up, and 15 (75%) of those uncontrolled at initial visit were controlled at follow-up. BP control among diabetic patients improved the most: from 1 (16.7%) to 5 (83.3%) (p=0.833) achieving control; statistical insignificance is likely due to sample size. Most patients reduced their BP with the addition of medications, but 2 (7.8%) achieved control with lifestyle changes (eg. reduced salt intake, increased exercise or improved home BP recording adherence) alone.

Conclusions:
UMSRFC has marginally exceeded CMS’s benchmark with 17 (65.4%) of patients with hypertension having a controlled blood pressure at follow-up. While this result demonstrates that a free clinic working with an uninsured population can provide quality care, UMSRFC will continue to work diligently toward the goal of controlled BP for 100% of patients with hypertension.
Abstract 115: Resuscitation Preferences of Older Patients Hospitalized with Heart Failure: Temporal Trends and Associations with Patient and Hospital Factors
Authors: Sadhu Justin S , Sadhu Eugene M , Hauptman Paul J , Rich Michael W
Published: July 2021

Background:
Preferences regarding end-of-life (EOL) care in patients (pts) with HF may be influenced by personal, cultural, and health system factors. We examined characteristics associated with cardiopulmonary resuscitation preferences among pts hospitalized for HF and explored whether rates of Do Not Resuscitate (DNR) status have changed over time.

Methods:
Using the California State Inpatient Databases from the Healthcare Cost and Utilization Project and the American Hospital Association Annual Survey Databases, we identified 297,156 pts aged ≥ 60 years hospitalized for HF between 2004 and 2011. The first eligible hospitalization for each patient was selected. DNR status documented within the first 24 hours of admission was assessed. Multivariable logistic regression was used to evaluate associations of DNR status with demographic factors, year of admission, median household income quartile, and hospital teaching status.

Results:
39,658 (13.4%) pts had a DNR order. Higher proportions with DNR were found among women than men (15.4% vs. 11.0%, p<.0001) and white pts than non-white pts (16.7% vs. 7.3%). Proportions of pts with DNR increased over the study period for both men and women (from 10.0% to 12.3% and 13.7% to 17.2%, respectively, p<.0001 for trend with time) and in both white pts (15.0% to 19.2%) and non-white pts (6.5% to 7.9%), but more rapidly for white pts (p=.02). In multivariable analysis adjusting for age, gender, race, and year of admission, odds ratios (ORs) for DNR were 1.5 per 5-year increase in age, 1.2 for women vs. men, and 2.0 for white vs. non-white pts. After adding income and hospital teaching status to the model, the respective ORs associated with each incremental increase in income quartile and receiving treatment in a teaching hospital were 1.1 and 1.2 (p<.0001 for both). ORs for age, gender, race, income, and hospital teaching status were essentially unchanged after adjustment for comorbidities.

Conclusion:
DNR status among pts hospitalized with HF is influenced by age, gender, race, and income in addition to hospital teaching status. The proportions of pts with DNR status have increased, but unequally among demographic subgroups. Continued efforts to understand the factors that influence preferences around resuscitation and EOL care are needed to provide truly patient-centered care.
Abstract 120: Organizational Culture Change to Reduce 30-day Mortality in Patients With Acute Myocardial Infarction: A Mixed Methods Study
Authors: Curry Leslie A , Linnander Erika , Brewster Amanda , Ting Henry , Krumholz Harlan M , McNatt Zahirah , Bradley Elizabeth H
Published: July 2021

Background:
Improving outcomes for patients with acute myocardial infarction (AMI) is a priority for hospitals, clinicians, and policymakers. Evidence suggests hospital organizational culture is linked to patient outcomes; however, few studies have attempted to change organizational culture in order to improve patient outcomes, and none have addressed mortality for patients with AMI. We seek to address these gaps through a novel longitudinal intervention study, Leadership Saves Lives (LSL). We hypothesize that we will observe: 1) positive shifts in key dimensions of hospital organizational culture associated with lower mortality rates for patients with AMI; 2) increased use of targeted evidence-based practices associated with lower mortality rates for patients with AMI; and 3) reduced in-hospital AMI mortality.

Methodology and Results:
We describe the methodology of LSL, a 3-year intervention study using a concurrent mixed methods design, guided by open systems theory and the AIDED model of diffusion, implemented in a national sample of 10 diverse U.S. hospitals and hospitals in their peer networks. Intervention hospital teams participate in: 1) annual convenings of the 10 hospitals; 2) semiannual workshops at each intervention hospital; and 3) a web-based learning community that includes a discussion board and a repository for resources and tools. We describe features of program design that allow us to promote and measure intervention fidelity, while also allowing for tailoring of the intervention to the unique local context in each hospital. We quantify changes in hospital practices, culture, and mortality through annual surveys of both intervention hospitals in their peer networks. In-person, in-depth interviews and selective observations of key interactions in care for patients with AMI allow us to describe the change process. The intervention began with an annual meting of the 10 intervention hospitals in June 2014. The first wave of survey data collection, hospital-specific workshops and qualitative data collection were completed between September and November 2014.

Conclusions:
LSL is novel in its use of a prospective longitudinal mixed methods approach in a diverse sample of hospitals, its focus on objective outcome measures of mortality, its attention to maintaining fidelity of the intervention across diverse hospital settings, and its examination of changes not only in the intervention hospitals but also in their peer hospital networks over time. This study adds to the methodological literature for the study of complex interventions to promote hospital organizational culture change, with direct impact on patients with AMI.
Abstract 123: Yield of Lipid Screening for Primary Prevention in a Young Cohort of Non-diabetic Patients Using the 2013 ACC/AHA ASCVD Risk Calculator
Authors: Patel Krishna , Hu Bo , Rothberg Michael
Published: July 2021

Background/Aim:
The 2013 ACC/AHA cholesterol management guidelines advise checking lipids in all adults aged > 20 years and repeating it every 4-6 years to identify individuals at high risk for atherosclerotic cardiovascular disease (ASCVD) because they may benefit from treatment. Statins can be considered in young adults with elevated ten year risk (defined as >5%) or LDL cholesterol >190 mg/dl. We aimed to assess the yield of lipid screening in this population.

Methods:
We conducted a retrospective cross-sectional study of patients aged 30-49 years who had lipid screening at their first primary care visit at a large health system from 2003-2012. Patients with known ASCVD and diabetes were excluded. We calculated 10-yr ASCVD risk by extrapolating the 2013 ACC/AHA ASCVD risk calculator to this population. Patients were subdivided by age in 5 year intervals, gender and history of smoking and hypertension. We calculated the percentage of patients with risk >5% and patients or LDL >190 mg/dl in each subgroup.

Results:
A total of 47,495 patients were included. The total number in each subgroup and the percentage with 10-yr estimated ASCVD risk >5% are shown in Table 1. Approximately half (49.2%, 23,388/47,495) the population had very low risk with only 18/ 23,388 (0.08%) non-smoking, non-hypertensive patients having an elevated risk. Only 1/15,618 (0.006%) non-smoking non-hypertensive females <50 years had a high risk. Less than 0.5% of non-smoking non-hypertensive males <45 years had a risk >5%. From 1% to >75% of population in other subgroups had an elevated risk depending on risk factors. Only 667/ 47,495 (1.4%) patients had LDL cholesterol >190 mg/dl.

Conclusion:
Yield of lipid screening is very low in non-smokers, especially in normotensive females <50 years and males <45 years, which constitute one-half of the screened population. Also, only 1.4% of the entire population cohort <50 years had elevated LDL>190 mg/dl. Guidelines for lipid screening should be reassessed for healthy non-smoking normotensive adults under 50 years of age.
Abstract 152: Persistence of Warfarin versus Dabigatran Therapy in Patients with Atrial Fibrillation: Results from the ORBIT AF Registry
Authors: Jackson Larry R , Kim Sunghee , Shrader Peter , Blanco Rosalia , Thomas Laine , Ansell Jack , Fonarow Gregg C , Gersh Bernard J , Go Alan S , Kowey Peter , Mahaffey Kenneth W , Hylek Elaine M , Burton Paul , Peterson Eric D , Piccini Jonathan P
Published: July 2021

Introduction:
Warfarin and non-vitamin K antagonist oral anticoagulants (NOACs) such as dabigatran are effective for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF). However, few analyses have compared persistence rates of warfarin vs. dabigatran-treated patients.

Methods:
The ORBIT-AF registry enrolled patients with AF from 173 clinical practices across the US. One-year persistence of warfarin vs. dabigatran was defined as treatment at baseline visit and at 1-year follow-up. Multivariable logistic regression analysis was used to identify characteristics associated with warfarin or NOAC persistent use.

Results:
At baseline, 6.4% (N=459/7,150) were treated with dabigatran and 93.6% (N=6,691/7,150) with warfarin. Patients treated with warfarin at baseline were older (74 vs. 71, p<.0001), had more NYHA class III/IV heart failure (7 vs. 5, p=.0007), lower creatinine clearance (77 vs. 88, p<.0001), higher CHA2DS2-VASc risk scores, and more prior CVA/TIA events (16 vs. 11, p=.003). Patients treated with dabigatran had more severe symptoms (EHRA class III: 20 vs. 14, p<.0001), higher rates of treatment with a rhythm control strategy (42.7 vs. 28.2, p<.0001), more attempts at cardioversion (38.3 vs. 32.1, p<.006), and catheter ablation of AF (9.8 vs. 5.2, p<.0001). At 12 months, adjusted persistence rates for warfarin were higher than dabigatran [82% (80-84) vs. 67% (61-73) p<.0001]. Factors independently associated with one year persistence were: African American race (OR 1.53, 95% C.I. 1.07-2.19, p=0.02), Hispanic race (OR 1.66, 95% C.I. 1.06-2.60), paroxysmal AF (vs. new onset) (OR 1.68, 95% C.I. 1.21-2.33, p=.002), LVH (OR 1.40, 95% C.I. 1.08-1.81, p=.01), persistent AF (vs. new onset) (OR 1.91, 95% C.I. 1.35-2.69, p=.0002), and CHA2DS2-VASc risk scores ≥ 2 (OR 1.94, 95% C.I. 1.18-3.19, p=.009).

Conclusion:
Persistence rates for warfarin were higher at one year than those on dabigatran. In addition, factors associated with persistence of warfarin include: African American and Hispanic race, type of AF including permanent and persistent, LVH, and CHA2DS2-VASc risk scores ≥ 2.
Abstract 16: Racial Disparities in Clinical Outcomes and Resource Utilization in Acute Ischemic Stroke Hospitalizations in the United States: Results from the 2012 National Inpatient Sample
Authors: Kumar Nilay , Venkatraman Anand , Garg Neetika
Published: July 2021

Background and objectives:
There are limited data on racial differences in clinical and economic outcomes of acute ischemic stroke (AIS) hospitalizations in the US. We sought to ascertain the effect of race on AIS outcomes in a population based retrospective cohort study.

Methods:
We used the 2012 National Inpatient Sample (NIS), which is the largest database of inpatient stays in the US, to identify cases of AIS using ICD9-CM codes 433.01, 433.11, 433.21, 433.31, 433.81, 433.91, 434.01, 434.11, 434.91 and 437.1 in patients >=18 years of age. Cases with missing data on race were excluded (5% of study sample). Primary outcome was in-hospital mortality. Secondary outcomes included proportion receiving endovascular mechanical thrombectomy (EMT) or thrombolysis, mean inflation adjusted charges and length of stay. Linear and logistic regression was used to test differences in continuous and categorical outcomes respectively. Survey techniques were used for all analyses.

Results:
There were 452, 330 hospitalizations for AIS in patients >=18 years in 2012. In univariate logistic regression using race as predictor, in-hospital mortality was significantly lower for Blacks (p<0.001), Hispanics (p=0.025) and Native Americans (p=0.047) compared to Whites. However, after adjusting for age, sex, Charlson comorbidity index, EMT and thrombolysis only blacks had a significantly lower mortality compared to whites (OR 0.74, 95% CI 0.66 - 0.82, p<0.001). Black patients were less likely to receive thrombolysis (OR 0.87, 95% CI 0.79 - 0.95; p=0.003) whereas Asian or Pacific Islanders were more likely to receive thrombolysis (OR 1.20, 95% CI 1.01 - 1.44; p=0.043) compared to whites. There was no difference in rates of EMT by race (p=0.18). Total charges and length of stay were significantly higher in racial minorities compared to whites (table).

Conclusions:
Blacks hospitalized for AIS have significantly lower in-hospital mortality compared to whites but are significantly less likely to receive thrombolysis compared to whites. Total charges and length of stay are significantly higher for racial minorities. Future studies should investigate mechanisms of this apparent protective effect of black race on in-hospital mortality in AIS.
Abstract 161: National Trends in Use of Radial Access for Percutaneous Coronary Intervention in China: 2001-2011
Authors: Zheng Xin , Curtis Jeptha , Hu Shuang , Yang Yuejin , Masoudi Frederick A , Spertus John A , Li Jing , Dharmarajan Kumar , Li Xi , Downing Nicholas , Yeh Robert W , Krumholz Harlan M , Jiang Lixin
Published: July 2021

Background:
The use of radial access for percutaneous coronary intervention (r-PCI) is associated with reduced risk of bleeding complications and higher patient satisfaction. However, the use of r-PCI differs greatly by country and is unknown in China. We examined trends in the adoption of r-PCI in China over the past decade and identified factors associated with its use.

Methods:
We used a two-stage random sampling strategy to create a nationally representative sample of 5,462 patients undergoing percutaneous coronary intervention (PCI) in China in 2001 (n=402; 24 sites), 2006 (n=1,390; 44 sites), and 2011 (n=3,670; 54 sites). We calculated the weighted proportion of patients receiving r-PCI in each time period and conducted multivariable analysis to identify the patient and hospital characteristics associated with not receiving r-PCI in 2011.

Results:
Among 5,462 patients who underwent PCI, the use of r-PCI increased markedly over time (2001: 3.4% [95% CI 0.0%-8.5%]; 2006: 36.5% [95% CI 34.2%-38.9%], 2011: 74.7% [95% CI 73.9-75.6]; P for trend <0.001). Increases in r-PCI use were widespread, including high-risk subgroups such as the elderly, women, and patients with acute coronary syndromes (Figure). In multivariable analysis of 3,670 patients undergoing PCI in 2011, cardiogenic shock and emergency PCI were strongly associated with failure to use r-PCI in 2011.

Conclusion:
Over a recent ten-year period, radial access became the predominant strategy for PCI in China, even among high-risk patients. This study demonstrates the responsiveness of the interventional cardiology community to emerging evidence. A deeper understanding of the factors facilitating r-PCI adoption in China may help increase its usage in countries in which r-PCI use remains low.
Abstract 172: Baseline Physical Activity and Clinical Outcomes in Patients with Diabetes Mellitus and Stable Ischemic Heart Disease: Analysis From BARI-2D Trial.
Authors: Otalvaro Orozco Lynda , Damluji Abdulla , Hawk Christopher , Marzouka George , Novoa Italo , Al-Damluji Mohammed S , Martinez Claudia A
Published: July 2021

Introduction:
We aimed to evaluate the differences in clinical outcomes among patients with DM and coronary heart disease according to their baseline physical activity status.

Methods:
We evaluated 2,343 patients with CHD and DM who underwent either prompt revascularization (PR) and intensive medical therapy (IMT) or IMT alone in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Patients were categorized according to their baseline physical activity status to sedentary, mild physical activity or moderate/strenuous activity. Primary end points were all cause mortality. Cox Regression analysis was used to evaluate the effects of baseline physical activity on all-cause-mortality.

Results:
Of 2,343 patients, 858 (37%) were able to achieve moderate/strenuous physical activity prior to randomization. Patients with sedentary life style and mild physical activity at baseline had worse survival compared to those with higher activity levels (Figure). In a Cox regression analysis, in patients randomized to IMT alone, there were no differences in mortality across physical activity levels. In the PR arm, sedentary and mild physical activity carried high risk of mortality compared to strenuous activity levels. Furthermore, patients in the low physical activity categories carried an increased risk of death if they were randomized to the insulin sensitizing arm of the trial.

Conclusions:
In this study, patients with DM and CHD, moderate/strenuous physical activity at baseline had improved survival compared to mild physical activity or sedentary life-style.
Abstract 216: Expert Review on Development of a Patient Measure for Statin Intolerance
Authors: Galipaeu Nina , Foody Joanne M , Sauris Aileen , Edelman Steven V , Davidson Michael , Shields Alan , Jacobson Terry A
Published: July 2021

Background:
Despite proven efficacy and safety of statins for use in dyslipidemia patients, a significant proportion of patients report intolerance to statins leading to treatment discontinuation. In 2014, the National Lipid Association (NLA) Statin Intolerance (SI) Panel recognized a pressing need to better understand patient-centric experience of SI. We believe combining a clinical perspective with patient experience of SI provides a comprehensive view on management of SI.

Objective:
This abstract describes clinician’s perspective of SI and patients’ presentation of SI in clinical practice.

Methods:
Experts were identified based on publications in the CV and SI research area. Interviews were conducted with health care professionals with known expertise and practice experience in evaluating and treating patients with SI. Interviewers were trained to follow the open-ended, semi-structured guide. The experts summarized their professional background, defined and described characteristics of SI, and their current management of SI in clinical practice. Additionally, targeted probes by the interviewers obtained information pertinent to research questions not spontaneously reported by experts. Following the completion of coding, data were pooled and qualitatively analyzed for common themes.

Results:
Four physicians and one nurse practitioner participated in the interviews and reported that they had been treating patients for a range of 19-29 years. Each of the experts provided a unique definition of SI, and four (80.0%) reported that SI is different than experiencing side effects from statins. A total of 13 characteristics reflecting the patient experience with SI were identified from the expert perspective: muscle symptoms (muscle pain (n=5; 100%), muscle weakness (n=4; 80%), muscle cramps (n=1; 20%), fatigue (n=1; 20%)), CNS symptoms (forgetfulness (n=2; 40%), headache(n=1; 20%)), or GI symptoms (i.e.- (n=1; 20%), burping, constipation, diarrhea, gas, indigestion, reflux, or upset stomach ). Experts displayed common approaches to the management of SI patients, including changing the type of statin the patient was receiving, usually at a lower dose, and using alternative treatments either alone or in combination with a statin (n=5; 100%). Regardless of the strategies used for managing SI patients, four experts (80.0%) indicated that they encouraged their patients to continue using statins despite experiences of intolerance.

Conclusions:
This study reports the opinions of 5 experts with varying backgrounds concluding that SI is multi-faceted and primarily characterized in the context of muscle pain and weakness which is best assessed from the perspective of the patient. These results, in concert with results from a literature review and patient interviews, will inform a comprehensive and patient-centric understanding of SI and a measure to assess this phenomenon.
Abstract 230: The Medically Managed Patient with Severe Symptomatic Aortic Stenosis in the TAVR Era: Patient Characteristics and Reasons for Medical Management
Authors: Dharmarajan Kumar , Foster Jill , Krishnaswamy Amar , Thourani Vinod H , Green Philip , Vavalle John P , DeYoung Marie , Wang Tracy Y
Published: July 2021

Background:
In the current era of surgical and transcatheter aortic valve replacement (AVR), patients with severe symptomatic aortic stenosis (AS) receiving medical management after referral to a valve treatment center have not been well-described.

Methods:
The ACC
Championing Care for the Patient with AS
initiative involved 454 patients referred for assessment of AS treatment options to 9 US valve treatment centers from 11/2012 to 6/2014. We compared clinical characteristics of patients with severe symptomatic AS receiving medical management versus AVR using chi-square, Fisher’s exact, and t-tests. We identified reasons for medical management using summary statistics.

Results:
Among 454 patients referred to a valve center, 42 (9%) received medical management for insufficient AS severity, 76 (17%) received medical management despite having severe symptomatic AS, and 336 (74%) underwent AVR. Patients receiving medical management despite severe symptomatic AS were older with higher STS predicted mortality than patients treated with AVR (Table). Common reasons for medical management were patient preference (43%, including waiting for commercial TAVR), medical futility (17%), inoperability (11%, including infeasible aortic annulus for TAVR), and temporary bridging with valvuloplasty (15%).

Conclusions:
In the current era of transcatheter and surgical AVR, medical management often occurs among patients with severe symptomatic AS referred for AVR. As medical futility, inoperability, and patient preferences commonly contribute to this decision, both valve treatment centers and referring physicians should be well versed in supportive care strategies to improve health outcomes in these patients.
Abstract 236: Trends in Hospitalization for Digoxin Toxicity and Subsequent Outcomes Among Medicare Beneficiaries in the United States, 1999-2011
Authors: Nuti Sudhakar V , Masoudi Frederick A , Freeman James V , Murugiah Karthik , Desai Nihar R , Ranasinghe Isuru , Shah Nilay D , Wang Yun , Krumholz Harlan M
Published: July 2021

Objective:
To characterize changes in rates of hospitalization for digoxin toxicity and trends in the associated mortality and readmission among older adults over a 12-year period in the United States.

Methods:
We studied 33,952,331 Medicare fee-for-service beneficiaries 65 years or older with a hospital discharge diagnosis of digoxin toxicity in the United States from 1999 to 2011. Outcome measures were rates of hospitalization for digoxin toxicity; in-hospital mortality; 30-day mortality; and 30-day readmission.

Results:
There were 20,957 hospitalizations for a principal or secondary diagnosis of digoxin toxicity between 1999 and 2011. The rate declined significantly from 15.2 per 100,000 person-years (95% confidence interval [CI]: 14.7-15.7) in 1999 to 2.1 per 100,000 person-years (95% CI: 1.9-2.3) in 2011 (p<0.001), representing an adjusted annual decline of 17.0% (95% CI: 16.2-17.0) (Figure 1). Between 1999 and 2011, the observed in-hospital and 30-day mortality rates associated with hospitalization for digoxin toxicity declined significantly, from 6.0% (95% CI: 5.2-6.8) to 3.3% (95% CI: 2.0-5.1) (p<0.01) and 14.0% (95% CI: 13.0-15.2) to 10.6% (95% CI: 8.2-13.4) (p<0.05), respectively, representing an annual decline for in-hospital mortality of 5.0% (95% CI: 3.7-7.2) and for 30-day mortality of 4.0% (95% CI: 3.1-5.7). The overall observed 30-day readmission rate declined significantly from 23.5% (95% CI: 22.1-24.9) in 1999 to 18.9% (95% CI: 15.6-22.3) in 2011 (p<0.05), but there was no significant decline in the adjusted annual change in 30-day readmission (1.0%, 95% CI: 0.0-1.7).

Conclusions:
In a national sample of Medicare beneficiaries, the rate of hospitalization for digoxin toxicity and subsequent mortality declined significantly between 1999 and 2011.
Abstract 238: Validation of In-hospital Mortality Prediction Models for Patients with Heart Failure
Authors: Lagu Tara , Stefan Mihaela , Pack Quinn , Atreya Auras , Kashef Mohammad A , Slawsky Mara , Valania Greg , Shieh Meng-Shiou , Pekow Penelope S , Lindenauer Peter K
Published: July 2021

Background:
Mortality prediction models, developed with the goal of improving risk stratification in hospitalized heart failure (HF) patients, show good performance characteristics in the datasets in which they were developed but have not been validated in external populations.

Methods:
We used a novel multi-hospital dataset [HealthFacts (Cerner Corp)] derived from the electronic health record (years 2010-2012). We examined the performance of four published HF inpatient mortality prediction models developed using data from: the Acute Decompensated Heart Failure National Registry (ADHERE), the Enhanced Feedback for Effective Cardiac Treatment (EFFECT) study, and the Get With the Guidelines-Heart Failure (GWTG-HF) registry. We compared to an administrative HF mortality prediction model (Premier model) that includes selected patient demographics, comorbidities, prior heart failure admissions, and therapies administered (e.g., inotropes, mechanical ventilation) in the first 2 hospital days. We also compared to a model that uses clinical data but is not heart failure-specific: the Laboratory-Based Acute Physiology Score (LAPS2). We included patients aged ≥18 years admitted with HF to one of 62 hospitals in the database. We applied all 6 models to the data and calculated the c-statistics.

Results:
We identified 13,163 patients ≥18 years old with a diagnosis of heart failure. Median age was 74 years; approximately half were women; 65% of patients were white and 27% were black. In-hospital mortality was 4.3%. Bland-Altman plots revealed that, at higher predicted mortality, the Premier model outperformed the clinical models. Discrimination of the models varied: ADHERE model (0.68); EFFECT (0.70); GWTG-HF, Peterson (0.69); GWTG-HF, Eapen (0.70); LAPS2 (0.74); Premier (0.81) (Figure).

Conclusions:
Clinically-derived inpatient heart failure mortality models exhibited similar performance with c statistics hovering around 0.70. A generic clinical mortality prediction model (LAPS2) had slightly better performance, as did a detailed administrative model. Any of these models may be useful for severity adjustment in comparative effectiveness studies of heart failure patients. When clinical data are not available, the administrative model performs similarly to clinical models.
Abstract 266: Heparin Documentation Improvement to Safely Manage Heparin Infusions
Authors: Manuel Venus , Morrison Jay
Published: July 2021

Background:
Documentation of intravenous (IV) heparin infusion dose/hold by nurses is a vital component in heparin infusion management. The barcode electronic medication administration system is used when administering and documenting medications but precludes the documentation of continuous IV infusion doses such as heparin.

Aim:
To increase documentation of IV Heparin Administration Documentation in the electronic nursing documentation system.

Methods:
We reviewed multiple adverse patient events that involved heparin infusions. When discussing these events, we identified a common trend regarding the inability for nurses to document heparin IV doses/holds in the nursing electronic documentation. Although heparin volume infusion is charted every 4 hours, this does not reflect the exact heparin dose that the patient received when factoring heparin hold orders and boluses. With the involvement of clinical informatics, physicians, nurses, and a quality consultant (QC), we developed a method for nurses to document heparin IV doses and holds via the electronic documentation (Figure 1). On October 30
th
2012, two Cardiovascular Step-Down (CVSD) units championed the heparin process improvement documentation. The nurses on these units receive targeted education about the process improvement change. Audits were performed daily during the first month of implementation and periodically by the QC. Electronic communication was also sent out throughout VUH regarding the changes in heparin documentation.

Results:
Documentation of administered dose increased from 46% to 71% across VUH regardless of the type or level of education to the change.

CVSD: Pre / Post n = 16/21

DOSE: 37.5% / 81%

Both DOSE & VOLUME: 31.3% / 71.4%

HOLD: 75% / 81%

Drop Down: 43% use (68.8% annotation)

Non ICU Control: Pre / Post n = 12 / 17

DOSE: 16.7% / 41.2%

BOTH DOSE & VOLUME: 8.3% / 11.8%

HOLD: 50% / 41.2%

Drop Down: 11.1% use (88.9% annotation)

ICU units were 100% in dose documentation post changes

Conclusion:
The heparin documentation change has increased the accuracy of the documentation of heparin dose, volume, and hold across VUH. Targeted education has the potential to increase compliance and adoption. The heparin dose documentation is now exported to an electronic heparin dashboard that physicians/providers can easily access.
Abstract 284: Association of Worsening Renal Function With Mortality and Heart Failure Readmissions in Patients Hospitalized With Acute Heart Failure
Authors: Palmer Jacqueline B , Friedman Howard , Waltman Johnson Katherine , Navaratnam Prakash , Gottlieb Stephen S
Published: July 2021

Background:
The impact of worsening renal function (WRF) on heart failure (HF)-related readmissions (HFR) and HF-related mortality among hospitalized acute HF patients was examined.

Methods:
A patient’s first acute HF hospitalization event (index) was identified in Cerner Health Facts® database (Jan 2008–March 2011). Patients were categorized as WRF (serum creatinine ≥0.3 mg/dL and ≥25% increase from baseline) persisting at discharge (WRFp), not persisting at discharge (WRFt), or non WRF. Outcomes were compared for the index hospitalization and cumulatively at 30, 180, and 365 days post discharge. Generalized linear model (HFR count) and logistic regression models (mortality) were constructed.

Results:
The acute HF patients (77% [42,507 of 55,436] non WRF, 10% [5,563 of 55,436] WRFp, and 13% [7,366 of 55,436] WRFt) were 53% [29,442 of 55,436] female with a mean age of 72.4 (±14.3) years. WRFp had higher index mortality rates (23.6% [1,312 of 5,563] vs 5.7% [418 of 7,366] vs 3.9% [1,673 of 42,507], P<0.0001) than WRFt and non WRF patients, respectively. For mortality, 70% [3,403 of 4,883] of deaths occurred at the index hospitalization. WRFp and WRFt patients combined had higher 30-day HFR counts than non WRF patients (0.12 vs 0.09, P<0.0001), but there was no difference between WRFp and WRFt. These observations were consistent across all cumulative time points and confirmed by multivariable analyses.

Conclusion:
Acute HF patients with WRF were more likely to die or be readmitted than non WRF patients. WRFp patients experienced higher HF-related mortality rates than WRFt patients but there were no differences in HFR between WRFt and WRFp.
Abstract 289: Patient Experience of Cardiac Arrest and Hypothermia Treatment
Authors: Decker Carole J , Ebberts Marci , Gialde Elizabeth
Published: July 2021

Background:
Cardiac arrest (CA) claims an estimated 300,000 lives in America each year even with cardio-pulmonary resuscitation (CPR) efforts. Additionally, of the patients who survive CPR and are discharged, many have suffered anoxic brain injury. Clinically, mild therapeutic hypothermia (TH) immediately post CA increases the odds of survival as well as improves neurological recovery and outcomes 6 months post-CA. Studies report that a small percent of CA patients recall their experience, but little is known regarding patient recall of hypothermia treatment post CA. This qualitative study seeks to understand the experience of survivors of CA and TH.

Methods:
A qualitative phenomenology study was conducted at a single center with survivors 12-24 months following CA and TH. Face-to-face or telephone interviews were audio recorded with each subjects’ permission and then transcribed verbatim. Transcripts were read in their entirety and searched for meaning-units that coalesced into themes. Consensus was achieved by all 3 nurse researchers and member-checked by being posed to a panel of survivors (1 was a subject of this study) which demonstrated thematic saturation yielding credible and trustworthy findings.

Results:
Six 6 survivors (67% [4 of 6] male, age 19-72 years) were interviewed. Four overall themes emerged:
Memory gap
- CA-
“I can tell you what people told me, because I don’t remember it”
and TH
-“I don’t remember being cold or uncomfortable or anything like that”
;
Filling in the gaps
-
“Several doctors, from what I understand, told my sister that I would have at least 70% brain loss if I was to wake up”
“Everything was told to me”;
and
Misconceptions
-
“Even though I have a pacemaker/defibrillator it only operates one side; it doesn’t operate the whole heart. At least that’s what they told me anyway” “Of course, they told me if (my heart rate) got to 300, my heart would explode”
; and
Divine coincidence
-
“My son had just taken a CPR course” “There was a nurse in the restaurant I was at”
. Additionally, several patients provided unsolicited compliments of the staff -
“I got absolutely outstanding care there ¼ I believe because they got me into hypothermia protocol so quickly, that was probably one of the contributing factors to my success”
. Though one patient stated
“I wish they’d left me alone”
as he had unknowingly been resuscitated against his wishes.

Conclusions:
Survivors of CA and TH report memory gaps, and then strive to fill in the gaps by family and staff descriptions. Additionally, survivors easily identified an unexplained coincidence that they felt allowed them to successfully recover from their CA. Further study is warranted regarding whether the creation of a specific treatment plan to assist in the accurate recall and story would enhance survivors and family in recovery.
Abstract 316: Using Reference Effect Measures to Identify Sources of Variation in 30-day Readmissions for Percutaneous Coronary Intervention
Authors: Glorioso Thomas J , Grunwald Gary K , O’Donnell Colin , Liu Wenhui , Maddox Thomas M , Ho P. M
Published: July 2021

Background:
Multilevel models for non-normal outcomes are widely used in outcomes research to estimate effects of covariates on outcomes, e.g. hospital readmissions following percutaneous coronary intervention (PCI). We refine Reference Effect Measures (REM) to compare effects of individual covariates, sets of covariates and random effects on the same scale (e.g. odds ratio, OR) and present a novel approach for displaying these effects. We illustrate this method by studying these sources of variation in 30-day readmission rates for Veterans Administration (VA) patients undergoing PCI.

Methods:
We used mixed effects logistic regression with 13 patient and 3 hospital covariates to study 30-day readmission rates in a national cohort of 45,521 VA Clinical Assessment, Reporting and Tracking (CART) patients who received a PCI during 10/2007-9/2012 at 49 VA hospitals. OR was used as a REM to compare percentiles of hospital or patient risk with median hospitals or patients to assess levels of variation.

Results:
Overall 30-day readmission rate was 11.5% ranging from 6.8% to 17.3% across the 49 sites. The figure below shows effects of individual patient and hospital covariates, combined effects of patient and hospital characteristics (shaded bars), and hospital random variation (shaded curve) for 30-day readmissions. The OR for comparing a 97.5
th
percentile hospital with a median hospital, all covariates being equal, was 1.43, which was substantially less than the 2.88 OR found when comparing patients at the same percentile of the combined patient risk distribution. The largest patient covariate effect (congestive heart failure) had an OR of 1.58, equivalent to comparing a 99
th
percentile hospital with a median hospital, or an 81
st
percentile risk patient to a median risk patient. Combining all hospital characteristics, the OR for a 97.5
th
percentile hospital versus a median hospital was 1.16.

Conclusions:
REMs are simple to compute, interpret and graph, and provide direct comparison on the same scale across random effects and covariates. The methods apply generally to linear, logistic, log, count, and time to event outcomes. These methods showed that patient risk drives 30-day readmission rates for VA PCI patients and the figure provided a new way of visualizing variation across these effects.