Journal: Circ Cardiovasc Qual Outcomes

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Abstract

Rationale and Design of the SAFE-PAD Study.

Secemsky EA, Raja A, Shen C, Valsdottir LR, ... Yeh RW, SAFE-PAD Investigators


Background:
Recent evidence from randomized controlled trials has raised concerns about the long-term safety of paclitaxel-coated peripheral devices used for femoropopliteal artery revascularization. In response to a call for more real-world data on the safety of these devices, the SAFE-PAD study (Safety Assessment of Femoropopliteal Endovascular treatment with Paclitaxel-coated Devices) was designed with input from the Food and Drug Administration to provide a long-term, comprehensive evaluation of the mortality risk associated with paclitaxel-coated devices among Medicare beneficiaries. Methods and Results SAFE-PAD is an observational cohort study of fee-for-service Medicare beneficiaries that underwent femoropopliteal artery revascularization with either a drug-coated device or nondrug-coated device from 2015 through 2018. All patients age 66 years or older who underwent revascularization will be identified using a combination ofprocedural codes, Current Procedural Terminology codes, and Healthcare Common Procedure Coding System C-codes. The safety end point of all-cause death will be updated semiannually and continued until the median duration of follow-up surpasses 5 years. Sub-group analyses will be conducted by device type, patient characteristics, and procedural setting. Registration: The SAFE-PAD study has been registered on URL: https://www.clinicaltrials.gov; Unique identifier: NCT04496544.
Conclusions:
The SAFE-PAD study will evaluate the long-term safety of drug-coated devices compared with nondrug-coated devices for femoropopliteal artery revascularization among a broad, real-world population of patients with peripheral artery disease.



Circ Cardiovasc Qual Outcomes: 12 Jan 2021:CIRCOUTCOMES120007040; epub ahead of print
Secemsky EA, Raja A, Shen C, Valsdottir LR, ... Yeh RW, SAFE-PAD Investigators
Circ Cardiovasc Qual Outcomes: 12 Jan 2021:CIRCOUTCOMES120007040; epub ahead of print | PMID: 33435732
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Abstract

Comparability of Event Adjudication Versus Administrative Billing Claims for Outcome Ascertainment in the DAPT Study: Findings From the EXTEND-DAPT Study.

Faridi KF, Tamez H, Butala NM, Song Y, ... Strom JB, Yeh RW


Background:
Data from administrative claims may provide an efficient alternative for end point ascertainment in clinical trials. However, it is uncertain how well claims data compare to adjudication by a clinical events committee in trials of patients with cardiovascular disease. Methods We matched 1336 patients ≥65 years old who received percutaneous coronary intervention in the DAPT (Dual Antiplatelet Therapy) Study with the National Cardiovascular Data Registry CathPCI Registry linked to Medicare claims as part of the EXTEND (Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data) Study. Adjudicated trial end points were compared with Medicare claims data withcodes from inpatient hospitalizations using time-to-event analyses, sensitivity, specificity, positive predictive value, negative predictive value, and kappa statistics. Results At 21-month follow-up, the cumulative incidence of major adverse cardiovascular and cerebrovascular events (combined mortality, myocardial infarction, and stroke) was similar between trial-adjudicated events and claims data (7.9% versus 7.2%, respectively; =0.50). Bleeding rates were lower using adjudicated events compared with claims (5.0% versus 8.6%, respectively; <0.001). The sensitivity and positive predictive value of comprehensive billing codes for identifying adjudicated events were 65.6% and 85.7% for myocardial infarction, 61.5% and 47.1% for stroke, and 76.8% and 39.3% for bleeding, respectively. Specificity and negative predictive value for all outcomes ranged from 93.7% to 99.5%. All 39 adjudicated deaths were identified using Medicare data. Kappa statistics assessing agreement between events for myocardial infarction, stroke, and bleeding were 0.73, 0.52, and 0.49, respectively.
Conclusions:
Claims data had moderate agreement with adjudication for myocardial infarction and poor agreement but high specificity for bleeding and stroke in the DAPT Study. Deaths were identified equivalently. Using claims data in clinical trials could be an efficient way to assess mortality among Medicare patients and may help detect other outcomes, although additional monitoring is likely needed to ensure accurate assessment of events.



Circ Cardiovasc Qual Outcomes: 12 Jan 2021:CIRCOUTCOMES120006589; epub ahead of print
Faridi KF, Tamez H, Butala NM, Song Y, ... Strom JB, Yeh RW
Circ Cardiovasc Qual Outcomes: 12 Jan 2021:CIRCOUTCOMES120006589; epub ahead of print | PMID: 33435731
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Abstract

Patient-Perceived Versus Actual Risk of Cardiovascular Disease and Associated Willingness to Consider and Use Prevention Therapy.

Navar AM, Wang TY, Li S, Mi X, ... Virani SS, Peterson ED
Background
Cardiovascular prevention guidelines use estimated 10-year atherosclerotic cardiovascular disease (CVD) risk based on the pooled cohort equations to guide treatment decisions and engage patients in shared decision-making. We sought to determine patient perceived versus actual risk of atherosclerotic CVD and associations with willingness for preventive therapy.
Methods
We evaluated calculated and perceived CVD risk among 4187 patients across 124 sites in the Patient and Provider Assessment of Lipid Management Registry. Ten-year risk was assessed using the pooled cohort equations; risk relative-to-peers was determined based on age-, sex-, and race-based percentiles; and patient estimates of risk were assessed using patient surveys. Poisson regression models evaluated associations between risk estimates, statin use, and willingness to take prevention therapy.
Results
Overall, there was no correlation between patients\' estimates of their 10-year CVD risk and calculated 10-year risk (ρ=-0.01, =0.46), regardless of age, sex, race, or socioeconomic status. The majority (72.2%) overestimated their 10-year CVD risk relative to the pooled cohorts equation (mean perceived 33.3% versus mean calculated 17.1%, <0.01). Patients\' perceptions of their risk relative-to-peers were slightly correlated with standardized risk percentiles (ρ=0.19, <0.01), although most had overly optimistic views of how risk compared with their peers. Increasing perceived risk was not associated with current statin use (=0.18) but was associated with willingness to consider future prevention therapy (<0.01). Perceived risk relative-to-peers was associated with increased prevalent statin use (risk ratio 1.04 per category increase [95% CI, 1.02-1.06]) and reported willingness for prevention therapy (risk ratio 1.11 [95% CI, 1.07-1.16]).
Conclusions
When asked, most patients overestimate their 10-year risk but hold an optimistic bias of their risk relative to age-, race-, and sex-matched peers. Providing accurate absolute risk assessments to patients without proper context may paradoxically decrease many patients\' perceived risk of CVD, thereby disincentivizing initiation of CVD risk reduction therapy.



Circ Cardiovasc Qual Outcomes: 12 Jan 2021:CIRCOUTCOMES120006548; epub ahead of print
Navar AM, Wang TY, Li S, Mi X, ... Virani SS, Peterson ED
Circ Cardiovasc Qual Outcomes: 12 Jan 2021:CIRCOUTCOMES120006548; epub ahead of print | PMID: 33435730
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Abstract

Use of ACE (Angiotensin-Converting Enzyme) Inhibitors and Risk of Lung Cancer: A Nationwide Nested Case-Control Study.

Kristensen KB, Hicks B, Azoulay L, Pottegård A
Background
Use of angiotensin-converting enzyme inhibitors (ACEIs) was associated with increased risk of lung cancer in a cohort study from the United Kingdom. We aimed to replicate these findings in a Danish population.
Methods
We conducted a nested case-control study using data from 4 Danish national health and administrative registries. New users of ACEIs or angiotensin II receptor blockers in Denmark from January 1, 2000 were followed until December 31, 2015, incident lung cancer, death, or emigration. Each lung cancer case was matched with up to 20 controls on age, sex, duration of follow-up, and year of cohort entry using risk-set sampling. Conditional logistic regression was used to estimate odds ratios (ORs) for incident, histologically verified lung cancer with high use of ACEIs defined as a cumulative dose above 3650 defined daily doses. We examined different cumulative doses of ACEI (≤1800, 1801-3650, >3650 defined daily doses), examined whether the association varied with lung cancer histology, and repeated the analyses using thiazides as active comparator.
Results
We included 9652 lung cancer cases matched to 190 55 controls. High use of ACEIs was associated with lung cancer (adjusted OR, 1.33 [95% CI, 1.08-1.62]). Lower cumulative doses showed neutral associations (≤1800 defined daily doses OR, 1.01 [95% CI, 0.94-1.09]; 1801-3650 defined daily doses OR, 1.03 [95% CI, 0.90-1.19]). CIs were wide and included the null when stratifying on histology. Using thiazides as active comparator yielded comparable results (OR, 1.34 [95% CI, 0.96-1.88]).
Conclusions
Use of high cumulative ACEI doses was associated with modestly increased odds of lung cancer although use of lower doses showed neutral associations. The established benefits of ACEIs should be considered when interpreting these findings.



Circ Cardiovasc Qual Outcomes: 12 Jan 2021:CIRCOUTCOMES120006687; epub ahead of print
Kristensen KB, Hicks B, Azoulay L, Pottegård A
Circ Cardiovasc Qual Outcomes: 12 Jan 2021:CIRCOUTCOMES120006687; epub ahead of print | PMID: 33435729
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Abstract

Perceived Versus Actual Risks of 30-Day Readmission in Patients With Cardiovascular Disease.

Xu H, Farmer HR, Granger BB, Thomas KL, Peterson ED, Dupre ME
Background
Cardiovascular disease (CVD) is the leading cause of hospitalization in the United States, and patients with CVD are at a high risk of readmission after discharge. We examined whether patients\' perceived risk of readmission at discharge was associated with actual 30-day readmissions in patients hospitalized with CVD.
Methods
We recruited 730 patients from the Duke Heart Center who were admitted for treatment of CVD between January 1, 2015, and August 31, 2017. A standardized survey was linked with electronic health records to ascertain patients\' perceived risk of readmission, and other sociodemographic, psychosocial, behavioral, and clinical data before discharge. All-cause readmission within 30 days after discharge was examined.
Results
Nearly 1-in-3 patients perceived a high risk of readmission at index admission and those who perceived a high risk had significantly more readmissions within 30 days than patients who perceived low risks of readmission (23.6% versus 15.8%, =0.016). Among those who perceived a high risk of readmission, non-White patients (odds ratio [OR], 2.07 [95% CI, 1.28-3.36]), those with poor self-rated health (OR, 2.30 [95% CI, 1.38-3.85]), difficulty accessing care (OR, 2.72 [95% CI, 1.24-6.00]), and prior hospitalizations in the past year (OR, 2.13 [95% CI, 1.21-3.74]) were more likely to be readmitted. Among those who perceived a low risk of readmission, patients who were widowed (OR, 2.69 [95% CI, 1.60-4.51]) and reported difficulty accessing care (OR, 1.89 [95% CI, 1.07-3.33]) were more likely to be readmitted.
Conclusions
Patients who perceived a high risk of readmission had a higher rate of 30-day readmission than patients who perceived a low risk. These findings have important implications for identifying CVD patients at a high risk of 30-day readmission and targeting the factors associated with perceived and actual risks of readmission.



Circ Cardiovasc Qual Outcomes: 11 Jan 2021:CIRCOUTCOMES120006586; epub ahead of print
Xu H, Farmer HR, Granger BB, Thomas KL, Peterson ED, Dupre ME
Circ Cardiovasc Qual Outcomes: 11 Jan 2021:CIRCOUTCOMES120006586; epub ahead of print | PMID: 33430612
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Abstract

The Cardiovascular Quality Improvement and Care Innovation Consortium: Inception of a Multicenter Collaborative to Improve Cardiovascular Care.

Bradley SM, Adusumalli S, Amin AP, Borden WB, ... Shreenivas S, Ho PM

Despite decades of improvement in the quality and outcomes of cardiovascular care, significant gaps remain. Existing quality improvement strategies are often limited in scope to specific clinical conditions and episodic care. Health services and outcomes research is essential to inform gaps in care but rarely results in the development and implementation of care delivery solutions. Although individual health systems are engaged in projects to improve the quality of care delivery, these efforts often lack a robust study design or implementation evaluation that can inform generalizability and further dissemination. Aligning the work of health care systems and health services and outcomes researchers could serve as a strategy to overcome persisting gaps in cardiovascular quality and outcomes. We describe the inception of the Cardiovascular Quality Improvement and Care Innovation Consortium that seeks to rapidly improve cardiovascular care by (1) developing, implementing, and evaluating multicenter quality improvement projects using innovative care designs; (2) serving as a resource for quality improvement and care innovation partners; and (3) establishing a presence within existing quality improvement and care innovation structures. Success of the collaborative will be defined by projects that result in changes to care delivery with demonstrable impacts on the quality and outcomes of care across multiple health systems. Furthermore, insights gained from implementation of these projects across sites in Cardiovascular Quality Improvement and Care Innovation Consortium will inform and promote broad dissemination for greater impact.



Circ Cardiovasc Qual Outcomes: 11 Jan 2021:CIRCOUTCOMES120006753; epub ahead of print
Bradley SM, Adusumalli S, Amin AP, Borden WB, ... Shreenivas S, Ho PM
Circ Cardiovasc Qual Outcomes: 11 Jan 2021:CIRCOUTCOMES120006753; epub ahead of print | PMID: 33430610
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Abstract

Higher Emergency Physician Chest Pain Hospitalization Rates Do Not Lead to Improved Patient Outcomes.

Natsui S, Sun BC, Shen E, Redberg RF, ... Kawatkar AA, Sharp AL


Background:
Wide variation exists for hospital admission rates for the evaluation of possible acute coronary syndrome, but there are limited data on physician-level variation. Our aim is to describe physicians\' rates of admission for suspected acute coronary syndrome and associated 30-day major adverse events. Methods We conducted a retrospective analysis of adult emergency department chest pain encounters from January 2016 to December 2017 across 15 community emergency departments within an integrated health system in Southern California. The unit of analysis was the Emergency physician. The primary outcome was the proportion of patients admitted/observed in the hospital. Secondary analysis described the 30-day incidence of death or acute myocardial infarction. Results Thirty-eight thousand seven hundred seventy-eight patients encounters were included among 327 managing physicians. The median number of encounters per physician was 123 (interquartile range, 82-157) with an overall admission/observation rate of 14.0%. Wide variation in individual physician admission rates were observed (unadjusted, 1.5%-68.9%) and persisted after case-mix adjustments (adjusted, 5.5%-27.8%). More clinical experience was associated with a higher likelihood of hospital care. There was no difference in 30-day death or acute myocardial infarction between high- and low-admitting physician quartiles (unadjusted, 1.70% versus 0.82% and adjusted, 1.33% versus 1.29%).
Conclusions:
Wide variation persists in physician-level admission rates for emergency department chest pain evaluation, even in a well-integrated health system. There was no associated benefit in 30-day death or acute myocardial infarction for patients evaluated by high-admitting physicians. This suggests an additional opportunity to investigate the safe reduction of physician-level variation in the use of hospital care.



Circ Cardiovasc Qual Outcomes: 11 Jan 2021:CIRCOUTCOMES119006297; epub ahead of print
Natsui S, Sun BC, Shen E, Redberg RF, ... Kawatkar AA, Sharp AL
Circ Cardiovasc Qual Outcomes: 11 Jan 2021:CIRCOUTCOMES119006297; epub ahead of print | PMID: 33430609
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Abstract

Micro-Randomized Trial Design for Evaluating Just-In-Time-Adaptive-Interventions Through Mobile Health Technologies for Cardiovascular Disease.

Golbus JR, Dempsey W, Jackson EA, Nallamothu BK, Klasnja P

Smartphone and wearable device use is rising broadly and can be leveraged for chronic disease management. Just-In-Time Adaptive Interventions (JITAIs) promise to deliver personalized, dynamic interventions directly to patients through use of push notifications from mobile devices. While JITAIs are a powerful tool for shaping health behavior, their application to cardiovascular disease management has been limited as they can be challenging to design. Herein we provide a general overview and conceptual framework for micro-randomized trials, a novel experimental study design that can be used to optimize JITAIs. Micro-randomized trials leverage mobile devices to sequentially randomize participants to types or levels of an intervention to determine the effectiveness of an intervention and time-varying moderators of those effects. Micro-randomized trials are an efficient study design that can be used to determine which intervention components to include in JITAI and to optimize their decision rules while maintaining the strength of causal inference associated with traditional randomized controlled trials.



Circ Cardiovasc Qual Outcomes: 11 Jan 2021; epub ahead of print
Golbus JR, Dempsey W, Jackson EA, Nallamothu BK, Klasnja P
Circ Cardiovasc Qual Outcomes: 11 Jan 2021; epub ahead of print | PMID: 33430608
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Abstract

Mendelian Randomization in Cardiovascular Research: Establishing Causality When There Are Unmeasured Confounders.

Bell KJL, Loy C, Cust AE, Teixeira-Pinto A

Mendelian randomization is an epidemiological approach to making causal inferences using observational data. It makes use of the natural randomization that occurs in the generation of an individual\'s genetic makeup in a way that is analogous to the study design of a randomized controlled trial and uses instrumental variable analysis where the genetic variant(s) are the instrument (analogous to random allocation to treatment group in an randomized controlled trial). As with any instrumental variable, there are 3 assumptions that must be made about the genetic instrument: (1) it is associated (not necessarily causally) with the exposure (relevance condition); (2) it is associated with the outcome only through the exposure (exclusion restriction condition); and (3) it does not share a common cause with the outcome (ie, no confounders of the genetic instrument and outcome, independence condition). Using the example of type II diabetes and coronary artery disease, we demonstrate how the method may be used to investigate causality and discuss potential benefits and pitfalls. We conclude that although Mendelian randomization studies can usually not establish causality on their own, they may usefully contribute to the evidence base and increase our certainty about the effectiveness (or otherwise) of interventions to reduce cardiovascular disease.



Circ Cardiovasc Qual Outcomes: 04 Jan 2021:CIRCOUTCOMES119005623; epub ahead of print
Bell KJL, Loy C, Cust AE, Teixeira-Pinto A
Circ Cardiovasc Qual Outcomes: 04 Jan 2021:CIRCOUTCOMES119005623; epub ahead of print | PMID: 33397121
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Abstract

Economic Evaluation of Catheter Ablation of Atrial Fibrillation in Patients with Heart Failure With Reduced Ejection Fraction.

Chew DS, Loring Z, Anand J, Fudim M, ... Mark DB, Piccini JP
Background
Randomized clinical trials have demonstrated that catheter ablation for atrial fibrillation in patients with heart failure with reduced ejection fraction may improve survival and other cardiovascular outcomes.
Methods
We constructed a decision-analytic Markov model to estimate the costs and benefits of catheter ablation and medical management in patients with symptomatic heart failure with reduced ejection fraction (left ventricular ejection fraction ≤35%) and atrial fibrillation over a lifetime horizon. Evidence from the published literature informed the model inputs, including clinical effectiveness data from meta-analyses. Probabilistic and deterministic sensitivity analyses were performed. A 3% discount rate was applied to both future costs and benefits. The primary outcome was the incremental cost-effectiveness ratio assessed from the US health care sector perspective.
Results
Catheter ablation was associated with 6.47 (95% CI, 5.89-6.93) quality-adjusted life years (QALYs) and a total cost of $105 657 (95% CI, $55 311-$191 934; 2018 US dollars), compared with 5.30 (95% CI, 5.20-5.39) QALYs and $63 040 (95% CI, $37 624-$102 260) for medical management. The incremental cost-effectiveness ratio for catheter ablation compared with medical management was $38 496 (95% CI, $5583-$117 510) per QALY gained. Model inputs with the greatest variation on incremental cost-effectiveness ratio estimates were the cost of ablation and the effect of catheter ablation on mortality reduction. When assuming a more conservative estimate of the treatment effect of catheter ablation on mortality (hazard ratio of 0.86), the estimated incremental cost-effectiveness ratio was $74 403 per QALY gained. At a willingness-to-pay threshold of $100 000 per QALY gained, atrial fibrillation ablation was found to be economically favorable compared with medical management in 95% of simulations.
Conclusions
Catheter ablation in patients with heart failure with reduced ejection fraction patients and atrial fibrillation may be considered economically attractive at current benchmarks for societal willingness-to-pay in the United States.



Circ Cardiovasc Qual Outcomes: 06 Dec 2020:CIRCOUTCOMES120007094; epub ahead of print
Chew DS, Loring Z, Anand J, Fudim M, ... Mark DB, Piccini JP
Circ Cardiovasc Qual Outcomes: 06 Dec 2020:CIRCOUTCOMES120007094; epub ahead of print | PMID: 33280436
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Abstract

Examining Hospital Variation on Multiple Indicators of Stroke Quality of Care.

Austin PC, Fang J, Yu B, Kapral MK
Background
Provider profiling involves comparing the performance of hospitals on indicators of quality of care. Typically, provider profiling examines the performance of hospitals on each quality indicator in isolation. Consequently, one cannot formally examine whether hospitals that have poor performance on one indicator also have poor performance on a second indicator.
Methods
We used Bayesian multivariate response random effects logistic regression model to simultaneously examine variation and covariation in multiple binary indicators across hospitals. We considered 7 binary patient-level indicators of quality of care for patients presenting to hospital with a diagnosis of acute stroke. We examined between-hospital variation in these 7 indicators across 86 hospitals in Ontario, Canada.
Results
The number of patients eligible for each indicator ranged from 1321 to 14 079. There were 7 pairs of indicators for which there was a strong correlation between a hospital\'s performance on each of the 2 indicators. Twenty-nine of the 86 hospitals had a probability higher than 0.90 of having worse performance than average on at least 4 of the 7 indicators. Seven of the 86 of hospitals had a probability higher than 0.90 of having worse performance than average on at least 5 indicators. Fourteen of the 86 of hospitals had a probability higher than 0.50 of having worse performance than average on at least 6 indicators. No hospitals had a probability higher than 0.50 of having worse performance than average on all 7 indicators.
Conclusions
These findings suggest that there are a small number of hospitals that perform poorly on at least half of the quality indicators, and that certain indicators tend to cluster together. The described methods allow for targeting quality improvement initiatives at these hospitals.



Circ Cardiovasc Qual Outcomes: 29 Nov 2020; 13:e006968
Austin PC, Fang J, Yu B, Kapral MK
Circ Cardiovasc Qual Outcomes: 29 Nov 2020; 13:e006968 | PMID: 33238729
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Abstract

Systemic Inflammatory Response Syndrome Is Associated With Increased Mortality Across the Spectrum of Shock Severity in Cardiac Intensive Care Patients.

Jentzer JC, Lawler PR, van Diepen S, Henry TD, ... Holmes DR, Kashani KB
Background
The systemic inflammatory response syndrome (SIRS) frequently occurs in patients with cardiogenic shock and may aggravate shock severity and organ failure. We sought to determine the association of SIRS with illness severity and survival across the spectrum of shock severity in cardiac intensive care unit (CICU) patients.
Methods
We retrospectively analyzed 8995 unique patients admitted to the Mayo Clinic CICU between 2007 and 2015. Patients with ≥2/4 SIRS criteria based on admission laboratory and vital sign data were considered to have SIRS. Patients were stratified by the 2019 Society for Cardiovascular Angiography and Interventions (SCAI) shock stages using admission data. The association between SIRS and mortality was evaluated across SCAI shock stage using logistic regression and Cox proportional-hazards models for hospital and 1-year mortality, respectively.
Results
The study population had a mean age of 67.5±15.2 years, including 37.2% women. SIRS was present in 33.9% of patients upon CICU admission and was more prevalent in advanced SCAI shock stages. Patients with SIRS had higher illness severity, worse shock, and more organ failure, with an increased risk of mortality during hospitalization (16.8% versus 3.8%; adjusted odds ratio, 2.1 [95% CI, 1.7-2.5]; <0.001) and at 1 year (adjusted hazard ratio, 1.4 [95% CI, 1.3-1.6]; <0.001). After multivariable adjustment, SIRS was associated with higher hospital and 1-year mortality among patients in SCAI shock stages A through D (all <0.01) but not SCAI shock stage E.
Conclusions
One-third of CICU patients meet clinical criteria for SIRS at the time of admission, and these patients have higher illness severity and worse outcomes across the spectrum of SCAI shock stages. The presence of SIRS identified CICU patients at increased risk of short-term and long-term mortality. Further study is needed to determine whether systemic inflammation truly drives SIRS in this population and whether patients with SIRS respond differently to supportive therapies for shock.



Circ Cardiovasc Qual Outcomes: 29 Nov 2020; 13:e006956
Jentzer JC, Lawler PR, van Diepen S, Henry TD, ... Holmes DR, Kashani KB
Circ Cardiovasc Qual Outcomes: 29 Nov 2020; 13:e006956 | PMID: 33280435
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Abstract

Site-Level Variability in 30-Day Patient Outcomes After Transcatheter Mitral Valve Repair in the United States.

Malik AO, Chhatriwalla AK, Saxon J, Hejjaji V, ... Kosinski A, Spertus JA
Background
Clinical trials have demonstrated health status benefit of transcatheter mitral valve repair (TMVr) with MitraClip in patients with mitral valve regurgitation. Real-world site-level variability in health status outcomes for TMVr, and factors associated with this variability, are unknown.
Methods
All patients undergoing TMVr procedure with MitraClip between November 2013 and March 2019 in the Transcatheter Valve Therapy Registry were included. Health status was measured at baseline and 30 days with the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score. Site-level variability in 30-day change in KCCQ-OS was examined by calculating the median odds ratio from a hierarchical logistic regression model, with ≥20-point improvement as the dependent variable. To define the extent to which patient characteristics, procedural characteristics (residual mitral valve regurgitation, periprocedural bleeding), site volume, and patients\' baseline health status accounted for variability in outcomes, the proportion of variability () explained by sequentially adding these variables to the model was quantified.
Results
Across 339 sites, 12 415 patients (mean age 79.0±9.5 years, 46.1%. females, 89.5% White) completed baseline and 30-day health status assessments. Mean KCCQ-OS score was 43.0±24.4 at baseline and 67.0±24.9 at 30-day follow-up. Across sites, the proportion of patients achieving a ≥20-point improvement in KCCQ-OS ranged from 12.5% to 100% and the adjusted median odds ratio was 1.58 (95% CI, 1.46-1.69). The greatest contribution to the variability in health status outcomes was from patients\' baseline KCCQ-OS score (=25%) with <1% of the variability explained by patient and procedural characteristics, and annual site volume.
Conclusions
There is moderate variation across sites in their patients\' achievement of health status benefits from TMVr, with patient\'s baseline health status accounting for the largest proportion of this variation. This underscores the importance of patient selection in supporting more consistent health status benefit from TMVr.



Circ Cardiovasc Qual Outcomes: 29 Nov 2020; 13:e006878
Malik AO, Chhatriwalla AK, Saxon J, Hejjaji V, ... Kosinski A, Spertus JA
Circ Cardiovasc Qual Outcomes: 29 Nov 2020; 13:e006878 | PMID: 33280434
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Abstract

Show Me the Money: Patients\' Perspectives on a Decision Aid for Sacubitril/Valsartan Addressing Out-of-Pocket Cost.

Dickert NW, Mitchell AR, Venechuk GE, Matlock DD, ... Speight CD, Allen LA
Background
Out-of-pocket medication costs for patients who have heart failure with reduced ejection fraction may be an important part of shared decision-making, but cost has generally been excluded from clinical discussions. This study reports patients\' perspectives on a decision aid for sacubitril/valsartan that explicitly addresses out-of-pocket costs.
Methods
Structured, in-depth interviews were conducted with 20 patients with heart failure with reduced ejection fraction from 2 medical centers to elicit their views on a publicly available decision aid for sacubitril/valsartan that explicitly incorporates considerations related to out-of-pocket costs. Qualitative descriptive analysis was conducted.
Results
Key themes identified were general enthusiasm for decision aids for medication decisions, openness on the part of patients to incorporation of cost into decision-making and the decision aid, requests for greater specificity regarding patient-specific cost, and challenges communicating evidence of benefit in a way that allows patients to make cost-benefit analyses for themselves. Patients also raised questions regarding logistical challenges of incorporating a decision aid into the normal clinical and decision-making workflow.
Conclusions
Patients were receptive to the inclusion of out-of-pocket cost as relevant in a decision aid for sacubitril/valsartan. Key challenges to effective integration of cost in these decisions include developing mechanisms for acquiring reliable patient-specific cost estimates and addressing patients\' difficulties (and sometimes skepticism) applying trial evidence to their own situation. In addition, implementation strategies are important to develop to facilitate decision aid integration for routine medical decisions into clinic workflow.



Circ Cardiovasc Qual Outcomes: 29 Nov 2020; 13:e007070
Dickert NW, Mitchell AR, Venechuk GE, Matlock DD, ... Speight CD, Allen LA
Circ Cardiovasc Qual Outcomes: 29 Nov 2020; 13:e007070 | PMID: 33302715
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Abstract

Target: Stroke Was Associated With Faster Intravenous Thrombolysis and Improved One-Year Outcomes for Acute Ischemic Stroke in Medicare Beneficiaries.

Man S, Xian Y, Holmes DN, Matsouaka RA, ... Schwamm LH, Fonarow GC
Background
The benefit of intravenous thrombolytic therapy for acute ischemic stroke is time dependent. To assist hospitals in providing faster thrombolytic treatment, the American Heart Association launched target: stroke quality initiative in January 2010 which disseminated feasible strategies to shorten door-to-needle times for thrombolytic therapy. This study aimed to examine whether target: stroke was associated with improved door-to-needle times and 1-year outcomes.
Methods
We analyzed Medicare beneficiaries aged ≥65 years receiving intravenous thrombolytic treatment for acute ischemic stroke at 1490 Get With The Guidelines-Stroke hospitals during January 2006 and December 2009 (preintervention, n=10 804) and January 2010 and December 2014 (postintervention, n=31 249). The median age was 80 years and 42.7% were male.
Results
The median door-to-needle times decreased from 80 minutes for the preintervention to 68 minutes for the postintervention (<0.001). The proportion of patients receiving intravenous thrombolysis with door-to-needle times 45 minutes and 60 minutes increased from 9.6% and 24.8% for preintervention to 17.1% and 40.6% for postintervention, respectively (<0.001). The annual rate of increase in the door-to-needle times of 60 minutes or less accelerated from 0.20% (95% CI, -0.43% to 0.83%) per each 4 quarters for preintervention to 5.68% (95% CI, 5.23%-6.13%) for postintervention (<0.001) which was further confirmed in piecewise multivariable generalized estimating analysis (adjusted odds ratio, 1.27 [95% CI, 1.19-1.35]). Cox proportional hazards analysis, after adjusting for patient and hospital characteristics and within-hospital clustering, showed that target: stroke was associated with lower all-cause readmission (40.4% versus 44.1%; hazard ratio, 0.91 [95% CI, 0.88-0.95]), cardiovascular readmission (19.7% versus 22.9%; hazard ratio, 0.85 [95% CI, 0.80-0.89]), and composite of all-cause mortality or readmission (56.0% versus 58.4%; hazard ratio, 0.96 [95% CI, 0.93-1.00]). The risk decline in all-cause mortality dissipated after risk adjustment (adjusted hazard ratio, 0.98 [95% CI, 0.94-1.02]).
Conclusions
Target: stroke quality initiative was associated with faster thrombolytic treatment times for acute ischemic stroke and modestly lower 1-year all-cause and cardiovascular readmissions.



Circ Cardiovasc Qual Outcomes: 29 Nov 2020; 13:e007150
Man S, Xian Y, Holmes DN, Matsouaka RA, ... Schwamm LH, Fonarow GC
Circ Cardiovasc Qual Outcomes: 29 Nov 2020; 13:e007150 | PMID: 33302714
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Abstract

A Blueprint for Productive Maintenance of Certification, But Is the American Board of Internal Medicine up to the Challenge?

Alyesh D, Gambhir A, Waase M, Remo B, ... Estes NAM, Heist EK

The future of the American Board of Internal Medicine Maintenance of Certification (MOC) program is at a crossroads. The current MOC program lacks a clear visible mission, adds to modern health care\'s onerous bureaucracy, and thus pulls physicians from the most important humanistic aspects of their profession. The aim of the MOC program should be to promote the best patient care by ensuring certified physicians maintain core skills through continuous education and evaluation. The program should focus on education and be designed with the rigorous obligations of practicing physicians in mind. Moving forward, the American Board of Internal Medicine should cocreate MOC with the physician community and apply innovative adult education techniques. Over time, data-driven methods and member feedback should be used to provide continuous program improvement. This review describes the origins of the current state of MOC, explores its evidence base, provides examples of model programs for the maintenance of complex professional skills, and outlines guiding principles for the future of MOC.



Circ Cardiovasc Qual Outcomes: 29 Nov 2020; 13:e006696
Alyesh D, Gambhir A, Waase M, Remo B, ... Estes NAM, Heist EK
Circ Cardiovasc Qual Outcomes: 29 Nov 2020; 13:e006696 | PMID: 33302712
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Abstract

Cardiovascular Disease Events and Mortality After Myocardial Infarction Among Black and White Adults: REGARDS Study.

Blackston JW, Safford MM, Mefford MT, Freeze E, ... Brown TM, Levitan EB
Background
Despite improvements in prognosis following myocardial infarction (MI), racial disparities persist. The objective of this study was to examine disparities between Black and White adults in cardiovascular disease (CVD), coronary heart disease, stroke, heart failure (HF), and mortality after MI and characteristics that may explain the disparities.
Methods
This prospective cohort study included 1122 REGARDS (Reasons for Geographic and Racial Differences in Stroke) study participants with incident MI between 2003 and 2016. We followed participants for subsequent CVD events (MI, stroke, HF hospitalization, or death from CVD; n=431), coronary heart disease events (MI or death from coronary heart disease; (n=277), stroke (n=68), HF events (HF hospitalization or death from HF; n=191), and all-cause mortality (n=527; 3-year median follow-up after MI).
Results
Among 1122 participants with incident MI, 37.5% were Black participants, 45.4% were women, and mean age was 73.2 (SD, 9.5) years. The unadjusted hazard ratio for CVD events comparing Black to White participants was 1.42 (95% CI, 1.17-1.71). Adjusting for sociodemographic characteristics did not attenuate the association (1.41 [95% CI, 1.14-1.73]), but further adjusting for pre-MI health status (1.25 [95% CI, 1.00-1.56]) and characteristics of the MI (1.01 [95% CI, 0.80-1.27]) resulted in substantial attenuation. Similar patterns were observed for the other outcomes, although the number of strokes was small.
Conclusions
Black individuals had a higher risk of CVD events and mortality after MI than White individuals. The disparities were explained by health status before MI and characteristics of the MI. These findings suggest that both primordial prevention of risk factors and improved acute treatment strategies are needed to reduce disparities in post-MI outcomes.



Circ Cardiovasc Qual Outcomes: 29 Nov 2020; 13:e006683
Blackston JW, Safford MM, Mefford MT, Freeze E, ... Brown TM, Levitan EB
Circ Cardiovasc Qual Outcomes: 29 Nov 2020; 13:e006683 | PMID: 33302710
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Abstract

Examining the Nocebo Effect of Statins Through Statin Adverse Events Reported in the FDA Adverse Event Reporting System (FAERS).

Moon J, Cohen Sedgh R, Jackevicius C

: This study aimed to evaluate whether the high frequency of reported statin adverse effects (AEs) may be associated with the nocebo effect. We compared nocebo-related subjective AEs with objective AEs and investigated factors potentially associated with the nocebo effect. : A retrospective cohort study was conducted using the FDA Adverse Event Reporting System (FAERS) between January 2010 and December 2019 for statins, including, atorvastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin. Subjective AEs included fatigue, subjective muscular, and nervous system AEs. Objective AEs were defined as hepatic and objective muscular AEs. We compared the number of subjective and objective AEs using the Mann-Whitney U test and examined trends in the frequency of subjective versus objective reports over time using linear regression with interaction terms. We evaluated the association between AEs and gender and country using linear regression. Quantitative detection of signals was estimated using proportional reporting ratio (PRR) and reporting odds ratio (ROR) for simvastatin. : Of 2,994,487 overall AE reports, more subjective than objective AEs were reported per quarter (mean±SD: 4,777±1,375.45 vs 999±276.95; <0.0001), and over time during the study period (<0.001). Females reported more subjective AEs than males per quarter (fatigue: 86.98 more per quarter, =0.035; subjective muscular AE: 417.95, <0.0001; nervous system AE: 273.60, <0.0001), but fewer objective muscular AEs (-125.23 per quarter, <0.0001). More subjective AEs and fewer objective AEs were reported per quarter in the US relative to other countries. Simvastatin-associated reports showed signals for higher objective muscular AEs relative to all other statins (ROR 1.53, 95% CI: 1.49-1.58). : This study found that significantly more subjective than objective AEs are reported for statins. Subjective statin AEs, potentially related to the nocebo effect are reported more often by females than by males, and in the US than in other countries.



Circ Cardiovasc Qual Outcomes: 08 Nov 2020; epub ahead of print
Moon J, Cohen Sedgh R, Jackevicius C
Circ Cardiovasc Qual Outcomes: 08 Nov 2020; epub ahead of print | PMID: 33161769
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Abstract

Association of Medicaid Expansion with Rates of Utilization of Cardiovascular Therapies Among Medicaid Beneficiaries Between 2011 and 2018.

Sumarsono A, Lalani H, Segar MW, Rao S, ... Fonarow GC, Pandey A

: The Affordable Care Act expanded Medicaid eligibility allowing low-income individuals greater access to healthcare. However, the uptake of state Medicaid expansion has been variable. It remains unclear how the Medicaid expansion was associated with the temporal trends in use of evidence-based cardiovascular drugs. : We used the publicly available Medicaid Drug Utilization and Current Population Survey to extract filled prescription rates per 1000 Medicaid beneficiaries of statins, antihypertensives, P2Y12 inhibitors, and direct oral anticoagulants (DOAC). We defined expander states as those who expanded Medicaid on January 1, 2014, and non-expander states as those who had not expanded by December 31, 2018. Difference-in-differences (DID) analyses were performed to compare the association of the Medicaid expansion with per-capita cardiovascular drug prescription rates in expander versus non-expander states. : Between 2011 and 2018, the total number of prescriptions among all Medicaid beneficiaries increased, with gains of 89.7% in statins (11.0 to 20.8 million), 76% in antihypertensives (35.3 to 62.2 million), and 37% in P2Y12 inhibitors (1.7 to 2.3 million). Medicaid expansion was associated with significantly greater increases in quarterly prescriptions (per 1000 Medicaid beneficiaries) of statins [DID estimate (95% CI): 22.5 (16.5 to 28.6), P<0.001], antihypertensives [DID estimate (95% CI): 63.2 (47.3 to 79.1), P<0.001], and P2Y12 inhibitors [DID estimate (95% CI): 1.7 (1.2 to 2.2), P<0.001]. Between 2013 and 2018, more than 75% of the expander states had increases in prescription rates of both statins and antihypertensives. In contrast, 44% of non-expander states saw declines in statins and antihypertensives. The Medicaid expansion was not associated with higher DOAC prescription rates [DID estimate (95% CI) 0.9 [-0.3 to 2.1], P=0.142). : The 2014 Medicaid expansion was associated with a significant increase in per-capita utilization of cardiovascular prescription drugs among Medicaid beneficiaries. These gains in utilization may contribute to long-term cardiovascular benefits to lower-income and previously underinsured populations.



Circ Cardiovasc Qual Outcomes: 08 Nov 2020; epub ahead of print
Sumarsono A, Lalani H, Segar MW, Rao S, ... Fonarow GC, Pandey A
Circ Cardiovasc Qual Outcomes: 08 Nov 2020; epub ahead of print | PMID: 33161766
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Abstract

Evidence-Based Policy Making for Public Health Interventions in Cardiovascular Diseases: Formally Assessing the Feasibility of Clinical Trials.

Foti K, Foraker RE, Martyn-Nemeth P, Anderson CAM, ... Whitsel LP, Appel LJ

Implementation of prevention policies has often been impeded or delayed due to the lack of randomized controlled trials (RCTs) with hard clinical outcomes (eg, incident disease, mortality). Despite the prominent role of RCTs in health care, it may not always be feasible to conduct RCTs of public health interventions with hard outcomes due to logistical and ethical considerations. RCTs may also lack external validity and have limited generalizability. Currently, there is insufficient guidance for policymakers charged with establishing evidence-based policy to determine whether an RCT with hard outcomes is needed before policy recommendations. In this context, the purpose of this article is to assess, in a case study, the feasibility of conducting an RCT of the oft-cited issue of sodium reduction on cardiovascular outcomes and then propose a framework for decision-making, which includes an assessment of the feasibility of conducting an RCT with hard clinical outcomes when such trials are unavailable. We designed and assessed the feasibility of potential individual- and cluster-randomized trials of sodium reduction on cardiovascular outcomes. Based on our assumptions, a trial using any of the designs considered would require tens of thousands of participants and cost hundreds of millions of dollars, which is prohibitively expensive. Our estimates may be conservative given several key challenges, such as the unknown costs of sustaining a long-term difference in sodium intake, the effect of differential cotreatment with antihypertensive medications, and long lag time to clinical outcomes. Thus, it would be extraordinarily difficult to conduct such a trial, and despite the high costs, would still be at substantial risk for a spuriously null result. A robust framework, such as the one we developed, should be used to guide policymakers when establishing evidence-based public health interventions in the absence of trials with hard clinical outcomes.



Circ Cardiovasc Qual Outcomes: 30 Oct 2020; 13:e006378
Foti K, Foraker RE, Martyn-Nemeth P, Anderson CAM, ... Whitsel LP, Appel LJ
Circ Cardiovasc Qual Outcomes: 30 Oct 2020; 13:e006378 | PMID: 32981337
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Abstract

Cardiovascular- and Bleeding-Related Hospitalization Rates With Edoxaban Versus Warfarin in Patients With Atrial Fibrillation Based on Results of the ENGAGE AF-TIMI 48 Trial.

Vilain K, Li H, Kwong WJ, Antman EM, ... Magnuson EA,


Background:
The ENGAGE AF-TIMI 48 trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) demonstrated noninferiority of once-daily 60 mg (30 mg dose-reduced) edoxaban compared with warfarin for prevention of stroke/systemic embolism in patients with atrial fibrillation. No previous analysis has explored the impact of treatment with edoxaban versus warfarin on rates of hospitalizations. Methods Detailed healthcare resource utilization data from ENGAGE AF-TIMI 48 for the 14 024 randomized patients who received at least one dose of study drug were used to compare the rates of bleeding- and cardiovascular-related hospitalizations for edoxaban versus warfarin. Hospitalization rates were calculated for each treatment group, and relative rates were estimated using Poisson regression. The influence of patient characteristics on the impact of edoxaban versus warfarin was evaluated through the inclusion of interaction terms. Results The overall rate of cardiovascular- or bleeding-related hospitalization was significantly lower for edoxaban than warfarin (relative rate [RR], 0.91 [95% CI, 0.85-0.97], =0.003). Rates of hospitalizations for cardiovascular reasons (RR, 0.91 [95% CI, 0.85-0.97], =0.004), stroke (RR, 0.80 [95% CI, 0.72-0.88], <0.0001), and for each stroke subtype (ischemic: RR, 0.89 [95% CI, 0.81-0.99], =0.03; hemorrhagic: RR, 0.60 [95% CI, 0.54-0.68], <0.0001) were also lower for edoxaban. Notably, significantly greater reductions with edoxaban versus warfarin were seen for ischemic stroke-related hospitalizations in vitamin K antagonist naive patients and patients with CHADS scores 4 to 6, previous stroke or transient ischemic attack, age ≥75, and no previous coronary artery disease. For nonstroke bleeding-related hospitalizations, greater reductions with edoxaban were seen in vitamin K antagonist naive patients, patients with CHADS scores 4 to 6, and patients with moderate renal dysfunction.
Conclusions:
Edoxaban 60 mg (30 mg dose-reduced) was associated with a significantly lower overall rate of cardiovascular- or bleeding-related hospitalization and significant reductions in the subcategories of cardiovascular-related, stroke-related, bleed-related, and nonstroke cardiovascular-related hospitalizations, when compared with warfarin. These results suggest the potential for cost offsets with edoxaban, with even greater reductions in higher-risk patients. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00781391.



Circ Cardiovasc Qual Outcomes: 30 Oct 2020; 13:e006511
Vilain K, Li H, Kwong WJ, Antman EM, ... Magnuson EA,
Circ Cardiovasc Qual Outcomes: 30 Oct 2020; 13:e006511 | PMID: 33148013
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Abstract

Sources of Hospital Variation in Postacute Care Spending After Cardiac Surgery.

Thompson MP, Yost ML, Syrjamaki JD, Norton EC, ... Pagani FD, Likosky DS
Background
Postacute care is a major driver of cardiac surgical episode spending, but the sources of variation in spending have not been explored. The objective of this study was to identify sources of variation in postacute care spending within 90-days of discharge following coronary artery bypass grafting (CABG) and aortic valve replacement (AVR) and the relationship between postacute care spending and other postdischarge utilization.
Methods and results
A retrospective analysis was conducted of public and private administrative claims for Michigan residents insured by Medicare fee-for-service and Blue Cross Blue Shield of Michigan/Blue Care Network commercial and Medicare Advantage plans undergoing CABG (n=11 208) or AVR (n=6122) in 33 nonfederal acute care Michigan hospitals between January 1, 2015 and December 31, 2018. Postacute care use was present in 9662 (86.2%) CABG episodes and 4242 (69.3%) AVR episodes, with respective mean (SD) 90-day spending of $4398±$6124 and $3465±$5759. Across hospitals, mean postacute care spending ranged from $3280 to $8186 for CABG and $2246 to $7710 for AVR. Inpatient rehabilitation and skilled nursing facility care accounted for over 80% of the variation spending between low and high postacute care spending hospitals. At the hospital-level, postacute care spending was modestly correlated across procedures and payers. Spending associated with readmissions, emergency department visits, and outpatient facility care was significantly different between low and high postacute care spending hospitals in CABG and AVR episodes.
Conclusions
There was wide hospital variation in postacute care spending after cardiac surgery, which was primarily driven by differential use and intensity in facility-based postacute care. Optimizing facility-based postacute care after cardiac surgery offers unique opportunities to reduce potentially unwarranted care variation.



Circ Cardiovasc Qual Outcomes: 30 Oct 2020; 13:e006449
Thompson MP, Yost ML, Syrjamaki JD, Norton EC, ... Pagani FD, Likosky DS
Circ Cardiovasc Qual Outcomes: 30 Oct 2020; 13:e006449 | PMID: 33176467
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Abstract

Cause of Death Among Patients With Peripheral Artery Disease: Insights From the EUCLID Trial.

Kochar A, Mulder H, Rockhold FW, Baumgartner I, ... Patel MR, Jones WS
Background
Peripheral artery disease is common and associated with high mortality. There are limited data detailing causes of death among patients with peripheral artery disease.
Methods
EUCLID (Examining Use of Ticagrelor in Peripheral Artery Disease) was a randomized clinical trial that assigned patients with peripheral artery disease to clopidogrel or ticagrelor. We describe the causes of death in EUCLID using mortality end points adjudicated through a clinical events classification process. The association between baseline factors and cardiovascular death was evaluated by Cox proportional hazards modeling. The competing risk of noncardiovascular death was assessed by the cumulative incidence function for cardiovascular death and the Fine and Gray method to ascertain the association between baseline characteristics and cardiovascular mortality.
Results
A total of 1263 out of 13 885 (9.1%) patients died (median follow-up: 30 months). There were 706 patients (55.9%) with a cardiovascular cause of death and 522 (41.3%) with a noncardiovascular cause of death. The most common cause of cardiovascular death was sudden cardiac death (20.1%); while myocardial infarction (5.2%) and ischemic stroke (3.2%) were uncommon. The most common causes of noncardiovascular death were malignancies (17.9%) and infections (11.9%). The factor most associated with a higher risk of cardiovascular death was age per 5 year increase (HR, 1.26 [95% CI, 1.20-1.32]). Female sex was associated with a lower risk of cardiovascular death (HR, 0.68 [95% CI, 0.56-0.82]). To evaluate the effect of noncardiovascular death as a competing risk, we superimposed the cumulative incidence function curve with the Kaplan-Meier curve. These curves closely approximated each other. After accounting for the competing risk of noncardiovascular death, the magnitude and direction of the factors associated with cardiovascular death were minimally changed.
Conclusions
Among patients with symptomatic peripheral artery disease, noncardiovascular causes of death reflected a high proportion (40%) of deaths. Accounting for noncardiovascular deaths as a competing risk, there was not a significant change in the risk estimation for cardiovascular death. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01732822.



Circ Cardiovasc Qual Outcomes: 30 Oct 2020; 13:e006550
Kochar A, Mulder H, Rockhold FW, Baumgartner I, ... Patel MR, Jones WS
Circ Cardiovasc Qual Outcomes: 30 Oct 2020; 13:e006550 | PMID: 33176462
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Abstract

Determinants of Value in Coronary Artery Bypass Grafting.

Brescia AA, Vu JV, He C, Li J, ... Likosky DS,


Background:
Over 180 000 coronary artery bypass grafting (CABG) procedures are performed annually, accounting for $7 to $10 billion in episode expenditures. Assessing tradeoffs between spending and quality contributing to value during 90-day episodes has not been conducted but is essential for success in bundled reimbursement models. We, therefore, identified determinants of variability in hospital 90-day episode value for CABG. Methods Medicare and private payor admissions for isolated CABG from 2014 to 2016 were retrospectively linked to clinical registry data for 33 nonfederal hospitals in Michigan. Hospital composite risk-adjusted complication rates (≥1 National Quality Forum-endorsed, Society of Thoracic Surgeons measure: deep sternal wound infection, renal failure, prolonged ventilation >24 hours, stroke, re-exploration, and operative mortality) and 90-day risk-adjusted, price-standardized episode payments were used to categorize hospitals by value by defining the intersection between complications and spending. Results Among 2573 total patients, those at low- versus high-value hospitals had a higher percentage of prolonged length of stay >14 days (9.3% versus 2.4%, =0.006), prolonged ventilation (17.6% versus 4.8%, <0.001), and operative mortality (4.8% versus 0.6%, =0.001). Mean total episode payments were $51 509 at low-compared with $45 526 at high-value hospitals (<0.001), driven by higher readmission ($3675 versus $2177, =0.005), professional ($7462 versus $6090, <0.001), postacute care ($7315 versus $5947, =0.031), and index hospitalization payments ($33 474 versus $30 800, <0.001). Among patients not experiencing a complication or 30-day readmission (1923/2573, 74.7%), low-value hospitals had higher inpatient evaluation and management payments ($1405 versus $752, <0.001) and higher utilization of inpatient rehabilitation (7% versus 2%, <0.001), but lower utilization of home health (66% versus 73%, =0.016) and emergency department services (13% versus 17%, =0.034).
Conclusions:
To succeed in emerging bundled reimbursement programs for CABG, hospitals and physicians should identify strategies to minimize complications while optimizing inpatient evaluation and management spending and use of inpatient rehabilitation, home health, and emergency department services.



Circ Cardiovasc Qual Outcomes: 30 Oct 2020; 13:e006374
Brescia AA, Vu JV, He C, Li J, ... Likosky DS,
Circ Cardiovasc Qual Outcomes: 30 Oct 2020; 13:e006374 | PMID: 33176461
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Abstract

Comparative Effectiveness of Dual Antiplatelet Therapy With Aspirin and Clopidogrel Versus Aspirin Monotherapy in Mild-to-Moderate Acute Ischemic Stroke According to the Risk of Recurrent Stroke: An Analysis of 15 000 Patients From a Nationwide, Multicenter Registry.

Lee HL, Kim JT, Lee JS, Park MS, ... Lee J, Bae HJ
Background
This study compared the effectiveness of dual antiplatelet therapy (DAPT) with clopidogrel-aspirin with that of aspirin monotherapy (AM) in mild-to-moderate acute ischemic stroke considering the risk of recurrent stroke using the Stroke Prognosis Instrument II (SPI-II) score.
Methods
This study is a retrospective analysis of data from a prospective, nationwide, multicenter stroke registry database between January 2011 and July 2018. We included patients with mild-to-moderate (National Institutes of Health Stroke Scale score ≤10), acute (within 24 hours of onset), noncardioembolic ischemic stroke. The primary outcome was a 3-month composite of stroke (either hemorrhagic or ischemic), myocardial infarction, and all-cause mortality. Propensity scores using the inverse probability of treatment weighting method were used to mitigate baseline imbalances between the DAPT and AM groups and within each subgroup considering SPI-II scores.
Results
Among the 15 430 patients (age, 66±13 years; men, 62.0%), 45.1% (n=6960) received DAPT and 54.9% (n=8470) received AM. Primary outcome events were significantly more frequent in the AM group (16.7%) than in the DAPT group (15.5%; =0.03). Weighted Cox proportional hazards models showed a reduced risk of 3-month primary vascular events in the DAPT group versus the AM group (hazard ratio, 0.84 [0.78-0.92]; <0.001), with no interaction between acute treatment type and SPI-II risk subgroups (=0.44). However, among the high-risk patients with SPI-II scores >7, a substantially larger absolute benefit was observed for 3-month composite vascular events in the DAPT group (weighted absolute risk differences, 5.4%), whereas smaller absolute benefits were observed among patients in the low- or medium-risk SPI-II subgroups (1.7% and 2.4%, respectively).
Conclusions
Treatment with clopidogrel-aspirin was associated with a reduction in 3-month vascular events compared with AM in mild-to-moderate acute noncardioembolic ischemic stroke patients. Larger magnitudes of the effects of DAPT with clopidogrel-aspirin were observed in the high-risk subgroup by SPI-II risk scores.



Circ Cardiovasc Qual Outcomes: 30 Oct 2020; 13:e006474
Lee HL, Kim JT, Lee JS, Park MS, ... Lee J, Bae HJ
Circ Cardiovasc Qual Outcomes: 30 Oct 2020; 13:e006474 | PMID: 33201737
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Abstract

Association Between Hospital Debriefing Practices With Adherence to Resuscitation Process Measures and Outcomes for In-Hospital Cardiac Arrest.

Malik AO, Nallamothu BK, Trumpower B, Kennedy M, ... Hejjaji V, Chan PS


Background:
Identifying actionable resuscitation practices that vary across hospitals could improve adherence to process measures or outcomes after in-hospital cardiac arrest (IHCA). We sought to examine whether hospital debriefing frequency after IHCA varies across hospitals and whether hospitals which routinely perform debriefing have higher rates of process-of-care compliance or survival. Methods We conducted a nationwide survey of hospital resuscitation practices in April of 2018, which were then linked to data from the Get With The Guidelines-Resuscitation national registry for IHCA. Hospitals were categorized according to their reported frequency of debriefing immediately after IHCA; rarely (0%-20% of all IHCA cases), occasionally (21%-80%), and frequently (81%-100%). Hospital-level rates of timely defibrillation (≤2 minutes), epinephrine administration (≤5 minutes), survival to discharge, return of spontaneous circulation, and neurologically intact survival were comparted for patients with IHCA from 2015 to 2017. Results Overall, there were 193 hospitals comprising 44 477 IHCA events. Mean patient age was 65±16, 41% were females, and 68% were of White race. Across hospitals, 84 (43.5%) rarely performed debriefings immediately after an IHCA, 82 (42.5%) performed debriefing sessions occasionally, and 27 (14.0%) performed debriefing frequently. There was no association between higher reported debriefing frequency and hospital rates of timely defibrillation and epinephrine administration. Mean hospital rates of risk-standardized survival to discharge were similar across debriefing frequency groups (rarely 25.6%; occasionally 26.0%; frequently 25.2%, =0.72), as were hospital rates of risk-adjusted return of spontaneous circulation (rarely 72.2%; occasionally 73.0%; frequently 70.0%, =0.06) and neurologically intact survival (rarely 21.9%, occasionally 22.2%, frequently 21.1%, =0.75).
Conclusions:
In a large contemporary nationwide quality improvement registry, hospitals varied widely in how often they conducted debriefings immediately after IHCA. However, hospital debriefing frequency was not associated with better adherence to timely delivery of epinephrine or defibrillation or higher rates of IHCA survival.



Circ Cardiovasc Qual Outcomes: 30 Oct 2020; 13:e006695
Malik AO, Nallamothu BK, Trumpower B, Kennedy M, ... Hejjaji V, Chan PS
Circ Cardiovasc Qual Outcomes: 30 Oct 2020; 13:e006695 | PMID: 33201736
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Impact:

This program is still in alpha version.