bluuebunny/crossref_metadata_2025 huggingface dataset:
Abstract 188: Comparison of Physician- and Patient-Assessed Impressions of Treatment Efficacy: Insights from the TERISA Clinical Trial
Authors: Yue Patrick , Li Yan , Olmsted Ann , Kosiborod Mikhail , Chaitman Bernard , Belardinelli Luiz , Spertus John A , Arnold Suzanne V
Published: March 2022

BACKGROUND:
Physicians typically rely on their qualitative interpretation of patients’ symptoms to evaluate the efficacy of antianginal therapy. However, the accuracy of this approach has not been examined.

METHODS:
Using data from the international multicenter TERISA clinical trial of patients with type 2 diabetes, CAD, and stable angina, we compared the physician’s assessment of change with patient-reported changes in angina. Physicians were asked to complete a well-validated visual analog scale (PGAVAS) at baseline and after 8 weeks of treatment. The PGAVAS asks the physician to rate the disease activity of their patient on a scale of 0 (“very good”) to 100 (“very bad”). A clinically important change in PGAVAS was defined as 8.5 points (i.e., half the baseline SD; a moderate change by Cohen’s effect size). Change from baseline in PGAVAS was compared with change from baseline in angina frequency (AF) as measured by an electronic daily diary. Among patients with an improvement in AF of ≥ 1 weekly episode, multivariable logistic regression examined predictors of physician recognition of change.

RESULTS:
Among 927 patients in TERISA, 892 (96%) had PGAVAS scores at baseline and at 8 weeks. Of the 605 patients with improvement in AF of ≥ 1 episode, 291 (48%) were recognized by the physician as improved (per the PGAVAS). Comparatively, of the 287 patients with unchanged or worsened AF, 197 (69%) were believed to be unchanged or worse by the physician. Overall, 45% of physicians’ assessments were discordant with their patients’ symptoms. There was a significant but poor correlation between the change in PGAVAS and change in patient-reported AF (Figure; r = 0.15). In multivariable regression, the degree of change in AF was significantly associated with physician recognition of change, with each 1 episode reduction in weekly AF associated with a 12% increased odds of physician recognition (95% CI 1.05-1.20). Age, sex, geography, and baseline AF were not associated with recognition.

CONCLUSION:
In TERISA, physicians were limited in their ability to recognize significant improvement in patients’ angina, although greater patient change was associated with greater physician recognition. These data suggest that patient-reported outcomes may provide added value to physicians in monitoring their patients’ angina and health status.
Abstract 20: Public Reporting of Mortality Rates for Cardiovascular Conditions Did Not Improve Patient Outcomes
Authors: Joynt Karen E , Orav E. John , Jha Ashish K
Published: March 2022

Background:
Public reporting may improve provider performance, although evidence for its impact has been mixed. In the U.S., public reporting of hospital performance became widespread in late 2004. Led by the Centers for Medicare and Medicaid Services (CMS), this program initially reported process-of-care metrics only, but in 2008 expanded to include public reporting of 30-day mortality rates. We set out to determine whether public reporting of mortality rates led to improvements in mortality rates for cardiovascular conditions.

Methods:
We used national Medicare data from 2005-2011 to compare trends in risk-adjusted 30-day mortality rates for acute myocardial infarction (AMI) and congestive heart failure (CHF), two publicly reported conditions, for hospitals participating in the Hospital Compare program throughout the study period. We considered 2005 through 2007 as the process reporting period (pre-mortality-reporting period), and 2008 through 2011 as the mortality reporting period. We performed linear regression analyses with hospital random effects to determine if trends in mortality changed after the implementation of public reporting of mortality rates. For comparison, we also selected two common non-reported cardiovascular conditions, atrial fibrillation and stroke, and examined trends in mortality rates over the same time period.

Results:
There were 3,617 hospitals in our sample. Mortality rates for AMI were improving at a rate of -0.09% per quarter during process reporting, but the improvement slowed to a rate of -0.05% per quarter during outcomes reporting (+0.04% per quarter, p=0.016). For CHF, mortality was improving at -0.03% per quarter during process reporting, but worsened at +0.06% per quarter during mortality reporting (change of +0.09% per quarter, p<0.001). Interestingly, improvements in mortality rates also slowed for the non-reported cardiovascular conditions over the study period (Table).

Conclusions:
We found that mortality rates for publicly reported conditions were improving slightly during the period when only processes of care were being reported, but that these improvements slowed or reversed once public reporting of mortality rates began. These findings suggest that public reporting may be necessary, but is clearly not sufficient, to improve patient outcomes.
Abstract 207: Gender Differences in Pre-Event Health Status of Young Patients with Acute Myocardial Infarction: Insights from the VIRGO Study
Authors: Dreyer Rachel P , Smolderen Kim G , Strait Kelly M , Beltrame John F , Lichtman Judith H , Lorenze Nancy , D'Onofrio Gail , Bueno Hector , Krumholz Harlan M , Spertus John A
Published: March 2022

Background:
Young women have a worse prognosis following acute myocardial infarction (AMI) then young men. Health status (symptoms, functioning and quality of life) prior to an AMI has received little attention and the pre-existing health status of young women presenting with an AMI, as compared with men, is unknown.

Methods:
VIRGO is a prospective observational study that enrolled 3,501 AMI patients (67% women) aged ≤55 years from the US and Spain. Clinical information was abstracted from medical records and health status data was collected through interviews at the time of the AMI [the Short Form 12 (SF-12), the EuroQol (EQ-5D) and the Seattle Angina Questionnaire (SAQ)]. To compare women and men, we used t-test/chi-square analyses and multivariable linear/logistic regression analysis, sequentially adjusting for socio-demographic, and co-morbidities, to identify clinical factors associated with patients’ health status.

Results:
Women were more likely to present with diabetes (39% vs. 27%), obesity (51% vs. 45%), stroke (5% vs. 2%), renal dysfunction (12% vs. 8%), lung disease (13% vs. 5%) and depression (48% vs. 24%; P<0.0001 for all). Prior to the event, women reported significantly worse general health scores (SF-12 physical summary score= 43±12 vs. 46±11, mental summary score= 44±13 vs. 48±11 and EQ-5D visual analog scale= 63±22 vs. 67±20, p<0.001 for all), more angina (SAQ angina frequency=83±22 vs. 87±18, p<0.001), poorer physical function (SAQ physical limitation=78±27 vs. 87±21, p<0.0001) and worse quality of life (SAQ QoL= 55±25 vs. 60±22, P<0.0001). Following adjustment for clinical covariates, female gender was independently associated with an increased odds of having more physical limitations due to angina (SAQ PL: OR=1.29, 95% CI 1.09,1.53, P=0.0025) poorer quality of life (SAQ QOL: β=-3.19; SE=0.89, P=0.0004); worse physical (SF-12: -1.04; 0.42, P=0.0136) and mental function (SF-12: -2.07; 0.46, P<0.0001).

Conclusion:
Young women with an AMI have poorer health status prior to their event than men. This suggests worse symptom control prior to an AMI and underscores the need to adjust for baseline health status in evaluations of gender-based disparities in young AMI patients.
Abstract 208: Hospital Readmissions After Left Ventricular Assist Device Implantation
Authors: Dunlay Shannon M , Herrin Jeph , Haas Lindsey R , Kushwaha Sudhir S , Grupper Avishay , Shah Nilay D
Published: March 2022

Background:
While implantation of left ventricular assist devices (LVAD) improves survival and quality of life in patients with advanced heart failure, very little is known about healthcare resource utilization, including hospital readmissions, post-LVAD.

Methods:
Administrative claims data from a large, national US health plan were used to identify privately insured and Medicare Advantage patients that received an LVAD (ICD-9-CM code 37.66) and survived to hospital discharge from January 1, 2006 through 31 August 31, 2013, and had at least six months coverage pre-LVAD. The individuals covered by this health plan, about 88 million in years 2003 to 2013, are geographically dispersed across the United States, with greatest representation in the South and Midwest census regions. Reasons for subsequent readmissions were categorized according to the AHRQ Clinical Classifications Software and risk factors for readmission analyzed using multiple failure Cox regression analysis. Patients were censored at the time of heart transplantation or end of coverage through November 30, 2013.

Results:
In total, 857 patients received an LVAD, of whom 693 (81%) survived to hospital discharge without undergoing heart transplantation (mean age 56 years, 77% male). After a median follow-up of 0.69 (interquartile range [IQR]: 0.31, 1.50) years, 1,659 readmissions occurred among 509 patients. Over this period, patients spent a median of 10.5 days (IQR: 0 -40 days) per followup year hospitalized. The number of readmissions per patient varied widely (0 to 20 per person), with 184 (26.6%) patients experiencing no readmissions, while 112 (16.2%) had 5 or more readmissions during follow-up. The most common reasons for readmission were device complications (291 readmissions in 155 patients), heart failure (246 readmissions in 135 patients), gastrointestinal bleeding (90 readmissions in 52 patients), and arrhythmia (88 readmissions in 55 patients). Readmission risk was higher in patients who had longer initial length of stay and more comorbid conditions.

Discussion:
There is tremendous variability in the readmission burden experienced post-LVAD, with some patients experiencing no readmissions while others are repeatedly hospitalized. LVAD therapy introduces a unique set of problems that often prompt readmission including device complications and gastrointestinal bleeding.
Abstract 214: Trends in Venous Thromboembolism in Hospitalized Heart Failure Patients in the United States: Analysis of the 2002 to 2011 Nationwide Inpatient Sample Database
Authors: Khera Sahil , Kolte Dhaval , Gass Alan , Palaniswamy Chandrasekar , Mujib Marjan , Jain Diwakar , Mittal Varun , Ahmed Ali , Aronow Wilbert S , Fonarow Gregg C , Panza Julio A
Published: March 2022

Background:
Hospitalized patients with heart failure (HF) are at increased risk of venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), and these conditions are associated with increased in-hospital mortality, longer length of stay and higher healthcare costs. Guidelines have emphasized the need for DVT prophylaxis, but it is unclear if the incidence of VTE has changed or remained constant over the past years.

Objectives:
To determine temporal trends in incidence and outcomes of VTE in hospitalized HF patients.

Methods:
We used the 2002 to 2011 Nationwide Inpatient Sample databases to identify all HF-associated hospitalizations in patients aged ≥18 years. Patients with VTE (DVT or PE) were then identified using appropriate ICD-9-CM codes. We stratified patients according to age, gender, and primary or secondary HF hospitalizations. Logistic regression analysis was used to examine temporal trends in incidence and outcomes of VTE as well as to compare outcomes between HF patients with or without VTE.

Results:
The overall incidence of DVT, PE and VTE among 42,573,726 HF-associated hospitalizations was 1.5%, 1.0% and 2.5%, respectively. From 2002 to 2011, there was a significant increase in the incidence of DVT (1.2% to 1.6%, adjusted OR 1.35, 95% CI 1.33-1.36), PE (0.8% to 1.2%, adjusted OR 1.91, 95% CI 1.88-1.93), and VTE (2.0% to 2.8%, adjusted OR 1.56, 95% CI 1.55-1.58). Similar upward trend was observed in all age groups, men and women, as well as primary and secondary HF hospitalizations. In-hospital mortality decreased in HF patients without VTE (6.9% to 5.0%; adjusted OR 0.81, 95% CI 0.80-0.81) as well as those with VTE (13.3% to 9.8%, adjusted OR 0.79, 95% CI 0.74-0.85) during the study period. However, compared to HF patients without VTE, those with VTE had significantly higher in-hospital mortality, longer length of stay, and higher total hospital charges (Table).

Conclusion:
Despite the aggressive guidelines for DVT prophylaxis, the overall incidence of VTE in hospitalized HF patients has increased over the past 10 years. This may be explained by increasing co-morbidities and aging of the HF population. Further studies are needed to explain these adverse trends and to examine rates of adherence to VTE prophylaxis guidelines in this high-risk patient population.
Abstract 225: Clinical Impact of Coronary Revascularization and Hospitalization for Unstable Angina in Acute Myocardial Infarction Patients
Authors: Smolderen Kim , Li Yan , Cohen David J , Arnold Suzanne V , Jones Phil J , Wang Tracy Y , Jenny Zhenxiang , Spertus John A
Published: March 2022

Background:
While clinical trials often use the endpoint of major adverse cardiovascular events (MACE) that include unstable angina (UA) and coronary revascularization outcomes, to power the studies, the relationship of these components to mortality is not known.

Methods:
Using a 24-center observational cohort study of 3283 AMI patients, we identified those with an unplanned coronary revascularization or unstable angina (UA) admission and calculated the subsequent rates of 1-year cardiovascular hospitalizations and 2-year mortality. Staged revascularizations electively performed 30 demographic, clinical, and health status data and achieved good balance between the cohorts (standardized difference <10% for all). Proportional hazards models of subsequent outcomes were compared for those who did and did not have an event after their AMI.

Results:
A total of 144 (4.39%) patients underwent unplanned revascularization and 140 (4.26%) were readmitted for UA after their AMI, of whom 9.6% and 30.2% died or were readmitted after an unplanned revascularization and 5.2% and 36.8% had these events after an UA admission. After propensity adjustment, the risk of mortality (HR=1.84) and cardiovascular rehospitalization (HR=5.13) were elevated among those who underwent revascularization vs. those who did not. The adjusted risk of 2-year mortality was not elevated after an UA event (HR=0.95) but the risk of cardiovascular rehospitalization was (HR=7.26;
Table
).

Conclusions:
Patients undergoing coronary revascularization or those readmitted for UA following AMI have greater subsequent risks for cardiovascular rehospitalizations as compared with those who do not get readmitted for these reasons. Subsequent survival is also worse in those who underwent coronary revascularization following AMI. From a prognostic standpoint, the inclusion of revascularizations and UA admissions as a component of a MACE outcome in clinical trials may be reasonable from a prognostic standpoint.
Abstract 234: Prevalence and Prognosis of Hyperkalemia in Dialysis and Non-Dialysis Patients with Acute Myocardial Infarction
Authors: Grodzinsky Anna , Goyal Abhinav , Gosch Kensey , McCullough Peter A , Fonarow Gregg , Palmer Biff , Masoudi Frederick A , Spertus John A , Kosiborod Mikhail
Published: March 2022

Background:
Hyperkalemia is a potentially dangerous complication during hospitalization for acute myocardial infarction (AMI), but its prevalence and prognostic importance in contemporary practice have not been described.

Methods:
We studied consecutive patients with AMI from 67 hospitals in the Cerner Health Facts database to assess the association between maximum in-hospital potassium levels (max K) and in-hospital mortality. Patients were stratified by dialysis status, and grouped into categories of max K (<5 mEq/L, 5-<5.5 mEq/L, 5.5-<6.0 mEq/L, 6.0-<6.5 mEq/L, and ≥ 6.5 mEq/L). Multivariable hierarchical logistic regression was used to adjust for multiple patient and site characteristics.

Results:
Of 38,689 patients, 886 (2.3%) were on dialysis. Hyperkalemia (max K ≥ 5.0 mEq/L) occurred in 23.6% of the overall cohort; 22.6% of non-dialysis patients; and 66.8% of dialysis patients. Moderate-severe hyperkalemia (max K ≥ 5.5 mEq/L) occurred in 9.8% of patients. There was an increase in mortality with higher max K levels; this relationship was linear in non-dialysis patients, while a plateau was observed in dialysis patients (Figure). Regardless of dialysis status, in-hospital mortality exceeded 15% once max K ≥5.5 mEq/L. The relationship between max K and mortality persisted after multivariable adjustment (adjusted odds ratios [OR] for max K of 5-<5.5, 5.5-<6.0, 6.0-<6.5, ≥ 6.5 vs. <5 were 2.03 (95% CI 1.79-2.31), 2.79 (2.35-3.31), 4.62 (3.74-5.71), 4.97 (3.96-6.25) respectively for dialysis patients; and 1.62 (1.41-1.87), 2.02 (1.68-2.43), 3.18 (2.51-4.03), 3.37 (2.60-4.36) respectively for non-dialysis patients).

Conclusions:
Hyperkalemia occurs in >20% of non-dialysis and >65% of dialysis patients with AMI. There is a graded mortality increase with higher max K levels, particularly in non-dialysis patients, with marked increases in mortality at even mild levels of hyperkalemia. Additional research into the determinants, pathophysiology, and clinical scenarios in which hyperkalemia contributes to mortality is warranted.
Abstract 235: Association Between Abnormal Ankle-Brachial Index and Accelerometer-Derived Sedentary and Exercise Time in the Asymptomatic General Population
Authors: Kulinski Jacquelyn , Ayers Colby , Das Sandeep , Sanghavi Monika , De Lemos James , Berry Jarett , Banerjee Subhash , Kumbhani Dharam
Published: March 2022

Objectives:
Sedentary behavior is a distinct adverse health risk factor that is independent of physical activity. The association between sedentary behavior, exercise activity and ankle-brachial index (ABI) is not well understood.

Methods:
We analyzed data from the National Health and Nutrition Examination Survey (NHANES) 2003-2004. Participants were included if they had ABI testing and at least one day of accelerometer data with exclusion of participants with self-reported anatomical or functional impairments to ambulation. Accelerometer counts reflect the intensity of activity in 1-minute intervals up to seven days for all participants. We used previously established exercise intensity-threshold criteria to quantify moderate-vigorous physical activity time. Sedentary time was defined as <100 counts/minute. We defined abnormal ABI as a value <1.0 (to include borderline values) in either foot. We performed multi-variable adjusted logistic regression analyses with sedentary time and exercise time as the independent variables and abnormal ABI as the dependent variable, adjusting for important risk factors and confounders. In a sensitivity analysis, we restricted the definition of abnormal ABI to <0.95.

Results:
We included 1,443 asymptomatic participants (mean age 61 years, 49% female, 55% current/prior smokers). The mean daily sedentary and exercise times in the study population were 454 ± 144 and 17.7 ± 20.3 minutes, respectively. 23.0% had an abnormal ABI (8.7% with ABI <0.9). In the final multivariable model, sedentary time was associated with increased odds of abnormal ABI (p=0.018) while exercise time was associated with reduced odds of abnormal ABI (p=0.003), independent of traditional risk factors and confounders (Figure, continuous variables per 1 standard deviation). Restricting the analysis to abnormal ABI<0.95, sedentary time and exercise time remained significant (p=0.024 and p=0.018, respectively).

Conclusions:
Sedentary time is associated with abnormal ABI values independent of exercise activity and other potential confounders in asymptomatic patients in the general population. Prospective studies are warranted to further evaluate the potential etiologic role of activity profiles on the development of peripheral arterial disease.
Abstract 246: Cost-analysis and Clinical Outcomes in Medicare Patients Who Have Received Holter Monitoring
Authors: Lenane Judith C , Layton Andrew J , Becker Shawn H , Alexander Jay H
Published: March 2022

Introduction:
The diagnostic odyssey for arrhythmia detection utilizing ambulatory ECG monitoring is not well documented. Our aim was to characterize the diagnosis, additional monitoring, clinical events and costs that occur after an index Holter in Medicare patients.

Methods:
We performed a retrospective, longitudinal analysis of the Medicare Standard Analytical Files (SAF), a 5% random sample of Medicare fee-for-service beneficiaries that contains every fully adjudicated claim. Beneficiary IDs were encrypted and consistent between all claims in a given year and across years. We studied years 2008 through 2011 in Medicare Carrier (Part B), Inpatient, Outpatient, and Denominator files. Inclusion criteria: 1) beneficiary with an index Holter in 2009, 2) enrolled in Medicare Parts A and B from one year prior to the date of the first Holter to death date or two years after the date of the index Holter event in 2009. Exclusion criteria: 1) use of a Holter or other cardiac monitoring device one year prior to the date of the first Holter use in 2009, 2) diagnosis of atrial fibrillation or ablation one year prior to the date of the first Holter. The population with an index Holter performed in 2009 was 46,840. After applying exclusion criteria, the study cohort reduced to 17,887 patients. To meet the aims of the study, four areas were identified: diagnosis, additional monitoring, clinical events and costs. Diagnosis was identified by ICD-9 codes and additional ambulatory ECG monitoring by CPT codes and date of service. Clinical events were identified by site of service, ICD-9 codes for Emergency Department, Inpatient, Observation stays and ICD-9 codes for stroke, TIA, and cardiac arrests. Principal diagnosis was used for clinical events. Costs were derived from claims data.

Results:
Eleven percent of the population attained a diagnosis with an index Holter without additional monitoring or clinical event (diagnosis attained cohort) and incurred total allowed charges in the two year period (charges) of $48 mil. Over a quarter (27%) of the population did not reach a diagnosis (no diagnosis cohort) and continued in the diagnostic and clinical event odyssey. Half of the patients in the no diagnosis cohort (13%) - experienced clinical events despite repeat monitoring and incurred charges of $63 million dollars. A significant number of those patients had their first clinical event within three months of their index Holter including stroke, TIA and cardiac arrest. The other half of the no diagnosis cohort (14%) received additional cardiac monitoring and total charges of $61 mil. Holter was the most commonly repeated test.

Conclusions:
Repeat monitoring, often of the same type as done initially, frequently did not yield a diagnosis and patients continued to experience clinical events at a substantial healthcare cost. Additional diagnostic paradigms should be explored to improve these patient and system outcomes.
Abstract 252: Champion Phoenix Study Economic Results: Direct Hospitalization Costs of Patients Receiving Clopidogrel or Cangrelor During Percutaneous Coronary Intervention
Authors: Pinto Duane S , Nicholson Gina , Harrington Robert A , Cyr Philip L , Bhatt Deepak L
Published: March 2022

Background:
Current guidelines recommend use of antiplatelet agents (oral P2Y12 inhibitors and/or GPIIb/IIIa inhibitors) in combination with antithrombin agents (bivalirudin or heparins) for PCI. Cangrelor, a new, intravenous, rapid on/off-set P2Y12 inhibitor reduced ischemic events vs. clopidogrel in the CHAMPION PHOENIX Trial. An economic substudy, from the perspective of the US healthcare system, was designed utilizing a sample of the US trial patients to identify the direct medical costs during index hospitalization among cangrelor vs. clopidogrel patients and the subgroup receiving bivalirudin as antithombin therapy during PCI.

Methods and Results:
Hospital bills were collected from a proportion of US patients in the CHAMPION PHOENIX trial. All US hospitals (n=53) were invited and 22 participated. Hospital bills were matched to clinical data from the CHAMPION PHOENIX trial endpoints including death, myocardial infarction (MI), unplanned revascularization, stent thrombosis, intraprocedural thrombotic complications, and major bleeding. Events were adjudicated by a blinded, independent committee using predefined criteria. A total of 1117 hospital bills (27.3% of US mITT population) were collected and analyzed. Patient demographics and comorbidities were similar to the overall CHAMPION PHOENIX US mITT population. Hospital costs were determined by multiplying itemized hospital charges and the cost-center specific cost-to-charge ratio obtained from hospital's Medicare cost report. Median index hospitalization costs for patients receiving cangrelor vs. clopidogrel were compared. Statistical significance was assessed using a Wilcoxon Sum-Rank test at a significance level of P<0.05. The median index hospitalization cost of patients receiving cangrelor (N=560) was $10308 vs. $10738 with clopidogrel (N=557) (P = NS), a numerical savings of $430. The median index hospitalization cost of patients receiving both cangrelor/bivalirudin (N=383) was $11139 vs. $11661 with clopidogrel/bivalirudin (N=389) (P = NS), a numerical savings of $522. There was no difference in the mean length-of-stay. MI (Δ$4675), stent thrombosis (Δ$7881), intraprocedural stent thrombosis (Δ$9342), and ACUITY major bleeding (Δ$6181) were associated with increased cost of hospitalization regardless of treatment (all p<0.05).

Conclusions:
This preliminary analysis of hospital bills from a subset of the CHAMPION PHOENIX US mITT population reveals a numerical reduction in direct medical costs for cangrelor patients (with or without bivalirudin). As these data represent a proportion of the population in a trial of very low event rates, further analysis is necessary utilizing multiple imputation methodology, and regression modeling to provide more robust data to identify factors associated with increased index hospitalization costs among the entire CHAMPION PHOENIX US mITT population.
Abstract 257: A Long-Term Comparison of Clinical and Economic Outcomes with Novel Oral Anti- Coagulants
Authors: Van Nuys Karen , Kuznik Andreas , Phatak Hemant , Iloeje Uchenna , Sullivan Jeffrey , Lakdawalla Darius N , Vasudeva Eshan , Weintraub William
Published: March 2022

Objectives:
Patients with non-valvular atrial fibrillation (NVAF) are routinely prescribed anticoagulants to prevent stroke. Traditional anticoagulants like warfarin are less expensive and less effective at preventing stroke than some novel oral anti-coagulants (NOACs). This study uses a widely published microsimulation model to compare population-wide outcomes associated with alternative approaches to preventing stroke among NVAF patients.

Methods:
The Health Economics Medical Innovation Simulation (THEMIS) was used to analyze clinical and economic outcomes among a representative sample of Americans age 51+. The lifetime evolution of disease and functional status was modeled for each individual under four scenarios: status quo using current NVAF treatment patterns, and three scenarios where NVAF patients are treated with apixaban, dabigatran, or rivaroxaban, respectively. Markov state transition probabilities were derived from the Health and Retirement Study; published cost estimates for stroke and other adverse events were used. NOAC prices were assumed to fall by 80% at patent expiration. The number of stroke-free years, bleeds and total medical expenditures were calculated for the entire population through 2062.

Findings:
Over 50 years, the three NOAC scenarios resulted in 28-31 million more stroke-free years and higher total medical expenditures compared to the status quo. Among NOACs, apixaban and dabigatran resulted in similar stroke outcomes, but apixaban had 1.4 million fewer bleeds and $6.9 billion lower total medical expenditures compared to dabigatran across the age 51+ population. Rivaroxaban resulted in higher stroke incidence, more major bleeds and higher total medical expenditures than the other two NOACs.

Conclusions:
While using NOACs in NVAF treatment raises drug costs compared to current practice, it also reduces stroke incidence. Among NOACs, apixaban does so at lower cost, with fewer bleeding events than either dabigatran or rivaroxaban.
Abstract 26: Comparison of Medicare Claims with Clinical Trial Outcomes for Follow-up of Older Individuals with Acute Coronary Syndrome
Authors: Brennan J. Matthew , O'Brien Sean , Milford-Beland Sarah , Marinac-Dabic Danica , Rao Sunil , Krucoff Mitchell , Normand Sharon-Lise , Tsai Thomas , Ross Joseph , Nelson Charlotte , Canos Daniel A , Eloff Benjamin , Sansing Veronica , Torosyan Yelizaveta , Xian Ying , Englum Brian , Ko Lisa , Graham Felicia , Peterson Eric D
Published: March 2022

Background:
Medicare administrative data has been proposed as an efficient alternative for long-term event detection. The accuracy of these data relative to investigator reported and event adjudicated results are unknown.

Methods:
We linked 3217 older patients (65+ years) with acute coronary syndromes (ACS) from 4 ACS clinical trials to Medicare inpatient standard analytic files (SAFs) using a deterministic linkage and indirect patient identifiers (e.g., sex, date of birth, date of index hospitalization). We compared event ascertainment for death, all-cause rehospitalization, myocardial infarction (MI), heart failure and revascularization to 180 days after hospital discharge. Up to four Medicare ICD-9-CM coding algorithms were evaluated for each outcome. Sensitivity, specificity and positive and negative predictive values were assessed for Medicare events considering trial records as the ‘gold standard’.

Results:
The 180 day incidences of adverse events following discharge were: death 4.6%, all-cause rehospitalization 50.9%, MI 5.6%, heart failure 15.1%, and any revascularization 13.2%. For most outcomes, Medicare claims displayed similar or higher event rates as those reported for trials. In general, Medicare claims had high sensitivity, specificity, and positive and negative predictive value when compared to trial outcomes; however, these differed depending on the Medicare coding algorithm used (Table).

Conclusions:
Medicare claims detect similar or greater numbers of events as those identified by existing clinical trial mechanisms. These data demonstrate the potential utility of administrative claims for efficient long-term follow-up of older patients enrolled in clinical trials or post-market surveillance efforts. Further investigation is needed to both optimize Medicare coding algorithms and determine which mechanism is most accurate among discordant reported events.
Abstract 260: Patient Characteristics, In-hospital Mortality and the Use of Comfort-Focused Care among Patients presenting with Acute Ischemic Stroke
Authors: Ali Syed F , Faheem Urooba , Cohen Abigail S , Singhal Aneesh B , Schwamm Lee H
Published: March 2022

Introduction:
Little is known about the factors associated with the decision to shift care to comfort measure only (CMO) in patients admitted with ischemic stroke, and how they compare to patients who die despite resuscitation. We sought to determine factors associated with use of CMO and the short term outcomes in these patients.

Methods:
Using our institutional GWTG database, we analyzed 2,816 consecutive stroke admissions from 7/07 - 9/12 and classified patients into early CMO (<day 2), late CMO (≥ day 2) or non-CMO. Patient characteristics, in-hospital mortality and median (IQR) length of hospital stay (LOS) was compared across all groups.

Results:
Among 2,816 patients, 114 (4.0%) were made early CMO, 169 (6.0%) late CMO and 2,533 (90.0%) were never made CMO. In-hospital death occurred in 343/2816 (12.2%) overall and 283/343 (82.5%) of these cases were made CMO prior to death. 75.4% of early CMO, 71.6% of late CMO and 2.4% of non-CMO died during the hospital stay. There were substantial differences between baseline characteristics, in-hospital treatments, complications and median LOS in non-CMO patients compared with early and late CMO patients (Table). Comparing in-hospital deaths among the early plus late CMO cases (n= 207) vs. non-CMO (n=60) cases, there were no differences in baseline characteristics other than use of IA therapy (16.5% vs. 5.0%, P=0.02) and median (IQR) days from arrival to death [3 (2, 7) vs. 5 (3, 8), p=0.03]. Among early CMO patients, just over half died within the same day (28.7%) or 2nd day (26.4%) of becoming CMO, and ~25% survived past the day of discharge to hospice.

Conclusion:
While comfort-focused care was provided to only 10% of stroke admissions, it occurred in over 80% of all patients who died in-hospital. Early CMO patients received aggressive intervention with IA therapy less often and appear to have had fewer infectious complications, suggesting that poor initial neurologic prognosis and advanced directives may have contributed more than progressive deterioration to the decision to change care goals. Larger prospective studies are needed to better understand the drivers of decision-making in this population, and set realistic expectations about the likely duration of patient survival after CMO designation and the need for hospice services.
Abstract 265: TeleStroke: Expanding Access and Coordination of Care from Acute Stroke to Follow-up
Authors: Hannon Peter M , Austin Jill , McCauley Maren J , Smith Daniel , Smith A. Gordon , Salari Ali , Majersik Jennifer J
Published: March 2022

Background:
The University of Utah Medical Center (UUMC) serves a wide geographical area, encompassing 10% of the continental US landmass. Stroke patients are often transported from remote facilities for specialty care. The UUMC Telestroke Center routinely provides acute care, but has only rarely been used for outpatient follow-up. The objective of this study was to develop a novel pathway for follow-up care after inpatient admissions for acute ischemic stroke (AIS) utilizing the existing telestroke infrastructure, with the goals of improving quality outcomes, reducing patient costs, and increasing access to care.

Methods:
Utilizing LEAN methodology, the existing care model was process-mapped to assess for potential areas of improvement. Over one month in 2013, a convenience sample of 27 inpatients admitted with AIS were surveyed to assess for potential barriers associated with travel to appointments, as well as for attitudes towards utilizing tele-health technologies for follow-up care. We analyzed primary residence patient zip-codes to determine which communities might be optimal for tele-health follow-up visits.

Results:
Ten patients (37%) lived ≤50 miles from UUMC; 7 (26%) 51-100 miles; 8 (30%)101-500 miles; and 2 (7.4%) > 500 miles away. Patients estimated the costs associated with a visit (excluding appointment fees) as: $0-9 (3.8%), $10-100 (42.3%), $101-500 (38.5%), $501-1000 (11.5%), and >$1000 (3.8%). Twenty-two patients (88%) said they would be interested in a tele-followup visit if it were closer to home and/or reduced travel time, and 59% of respondents said they would actually prefer this option to an in-office visit. Due to these results, an ideal community clinic partner was identified based upon geographic patient demographics, existing tele-health infrastructure, university-based scheduling, shared billing and meaningful-use software, and an expressed interest in collaboration. Follow-up tele-visits will link a stroke specialist physician at UUMC with a patient at the community clinic via 2-way audio-video telehealth equipment. A medical assistant with additional training in the neurologic exam will help facilitate the visit. Clinic training and coordination has already occurred, and a go-live date is anticipated for late February 2014.

Discussion:
A proof-of-concept health care model has been established at UUMC to provide tele-health follow-up after AIS admission to reduce significant barriers to follow-up care. Outcome metrics will include patient satisfaction, stroke and all cause readmission rates, medication compliance, and outpatient follow-up rates. Beyond increasing access to care, we hope that utilizing remote sites for follow-up will increase communication and coordination with primary care providers at these sites, in essence building a remote care “neighborhood” for our patients and optimizing care after discharge.
Abstract 272: Preliminary Data from RESOLVE (Rapid Evaluation for Stroke Outcomes using Lytics in Vascular Events) Study
Authors: Summers Debbie , Chhatriwalla Emily , Gialde Elizabeth , Spertus John , Decker Carole
Published: March 2022

Background:
Communicating the risks and benefits of recombinant tissue plasminogen activator (rt-PA) for the treatment of acute ischemic stroke (AIS) is complex and often a hurried conversation in the emergency department (ED). Visual decision aids have been shown to be superior to standard treatment decision counseling and useful in emergency decision-making. Current rt-PA tools primarily focus on harmful risks while minimizing the positive benefits of treatment. Despite evidence to support enhancement of patient understanding of rt-PA treatment, use of these materials remains low. This study explored patient and family caregiver (CG) recall of rt-PA information provided, and comprehension of AIS and rt-PA education prior to piloting an enhanced individualized risk and benefit decision tool for rt-PA treatment in the ED.

Methods:
The goal is to interview 150 consecutive AIS rt-PA eligible patients and their CG to obtain feedback on the type of information (verbal or visual), comprehension and recall of risks and benefits provided in the ED. Currently 20 individuals (stroke patients = 8 and CG =12) at one large metropolitan medical center have completed the study. The participants were 35% (7/20) male; mean age 55.9 years, and 100% (20/20) of the survivors received rt-PA.

Findings:
All participants (20/20) received information on treatment options for AIS education in the ED. Ninety five percent (19/20) of patients did not recall receiving any visual material used in education of risks and benefits. Most patients (18/20) reported understanding that a stroke was caused by a clot in the brain, however only 30% (6/20) recalled having heard of rt-PA prior to coming to the hospital. Forty-five percent (9/20) of the subjects perceived the descriptions of rt-PA with its risks and benefits as being completely clear whereas 20% (4/20) reported they were not at all clear.

Conclusions:
Preliminary findings showed that less than half of the patients and CG felt the education was clear. However additional interviews are planned. Preliminary insights suggest an opportunity to use an individualized risk and benefit decision tool to inform and engage patients and CG regarding treatment decisions. We believe this can be accomplished without increasing the door to needle time in administration of rt-PA.
Abstract 278: Improvement to Pre-Hospital ECG Image Transmission by a Novel iPhone Application Utilizing Mobile Phone Signal Enhancement Technology
Authors: Burt David R , Nguyen Christopher , Patel Vatsal , Patek Steven
Published: March 2022

Introduction:
Field transmission of pre-hospital ECG images to facilitate advance activation of the STEMI system of care has been shown to be effective in improving patient care and prognosis. Current commercial wireless ECG transmission systems available are effective, but are expensive to implement and maintain. Head to head testing was performed using an iPhone application to mediate ECG image transmission on three national cellular carriers in comparison to one commercial ECG transmission system. This resulted in comparable performance particularly in signal rich coverage environments contained three or greater bars.

Hypothesis:
An iPhone application that mediates pre-hospital ECG image transmission could be a cost effective alternative to current commercial systems incorporated in the pre-hospital STEMI system of care. Using a mobile phone signal booster could enhance application performance to consistently transmit in all signal coverage environments.

Testing:
The application was tested on three national cellular carriers with two commercial systems. Data was collected with and without the addition of the mobile phone signal booster at 75 waypoints covering the entire signal coverage environment. Application performance was determined by the average percentage of successful transmission and duration of transmission within the total signal coverage environment.

Results:
As shown in Figure 1, using the mobile phone signal booster resulted in marked improvements to successful transmission. Performance of the carriers under boosted conditions was merged, as the differences were not statistically significant enough to warrant differentiation. Within the signal-limited environment, the application displayed superior reliability to the two commercial systems, while in the signal rich environment it was comparable. Minimal improvement was also seen in the duration of transmission of the application, although it was more apparent within the signal limited environment than in the signal rich environment.

Conclusion:
The addition of the mobile phone signal booster enhances the performance of the iPhone application, allowing it to successfully transmit ECGs more consistently than commercial systems in all signal coverage environments.
Abstract 308: Percutaneous Coronary Intervention Outcomes in HIV+ and HIV- Patients
Authors: Cua Bennett , Justice Amy , McGinnis Kathy , Kravetz Jeffrey , Budoff Matthew , Rodriguez-Barradas Maria , Gibert Cynthia , Maddox Thomas , Ho Michael , Leaf David , Rimland David , Bedimo Roger , Butt Adeel , Crane Heidi , Alcorn Charles , Lombo Bernardo , Chang Joyce , Freiberg Matthew
Published: March 2022

Background:
Studies suggest HIV infected (HIV+) people have similar rates of major adverse cardiovascular events (MACE) after AMI and/or after percutaneous coronary interventions (PCI) compared to uninfected (HIV-) people. However, these studies were limited by a lack of CD4 cell count and/or stent type data. Low CD4 cell count and bare metal stents (BMS) are associated with higher MACE rates than high CD4 cell count and drug eluding stents (DES), respectively. Our study compared the rates and risk of MACE and mortality after PCI between HIV+ and HIV- stratified by stent type and CD4 cell count.

Methods:
We included 611 HIV+ and 1,564 HIV- from the Veterans Aging Cohort Study Virtual Cohort, a prospective, longitudinal, observational study of HIV+ and 1:2 matched HIV- who underwent PCI with stent placement between 1/2002-1/2010. 1-year incidence rates (IR) per 1000 person years and 95% confidence intervals (CI) for MACE and mortality were calculated by HIV and CD4 (<200/≥200 cells/mm3) status and stent type (BMS vs. DES). To compare 1-year MACE and mortality between HIV+ with CD4 <200 and ≥200 to HIV-, hazard ratios (HR) were generated from multivariate Cox proportional hazards models adjusted for age, gender, race/ethnicity, hypertension, diabetes, dyslipidemia, smoking, hepatitis C, renal disease, anemia, and substance use. MACE was defined as a composite of repeat PCI, CABG, AMI using ICD9 and ICD10 codes and all-cause mortality.

Results:
There were 594 MACE including 108 deaths after PCI. Percent receiving DES was similar by HIV status (57% in HIV+ vs. 56% in HIV-). MACE rates were higher among those who received BMS (429.0, 95% CI 383.8-479.5) compared to DES (318.7, 95% CI 285.5-355.9), p=0.004 and the pattern is similar by HIV status. MACE rates were similar between HIV+ with CD4≥200 and HIV- (p=0.8), but higher for HIV+ with CD4<200 (p<0.001 compared to both HIV+ with CD4≥200 and HIV-). Mortality was also similar between HIV+ with CD4≥200 and HIV- (p=0.2), but higher for HIV+ with CD4<200 (p<0.01 compared to both HIV+ with CD4≥200 and HIV-). Adjusted HRs are shown in the table.

Conclusion:
Stent type received did not vary by HIV status. HIV+ with CD4<200 have worse outcomes post PCI with stent placement than both HIV- and HIV+ with CD4≥200. Management of HIV may be important for decreasing MACE and mortality after PCI.
Abstract 315: Anemia predicts 30-Day Hospital Readmission for Heart Failure in African Americans
Authors: Mansour Ibrahim N , Gheith Hana H , Dowdy Zachary , Dickens Carolyn , Stamos Thomas D
Published: March 2022

Background:
Anemia is a frequently encountered comorbidity that affects both death and hospitalization in patients with heart failure (HF). The effect of anemia on 30-day hospital readmission in African Americans (AA) with HF has not been studied.

Methods:
We retrospectively enrolled all 243 (61% female) self-reported AA adults admitted to the University of Illinois at Chicago hospital with the diagnosis of HF from January 2011 to December 2012. Extensive medical chart reviews were performed.

Results:
The prevalence of anemia with hemoglobin (Hb) <12g/dl was 64.6%. After adjusting for factors known to affect readmission (table), lower Hb (<12g/dl) levels were associated with increased 30-day readmission rates (OR 0.814, 95% CI 1.6-20.7, p=0.008) in a Cox proportional hazard logistic regression model.

Conclusion:
Lower Hb levels are associated with higher 30-day readmission rates in hospitalized AA patients with HF. Interventions towards appropriate treatment and prevention of anemia in AA with HF might reduce their readmission rates and improve their outcome.