Search

BACKGROUND: Among patients hospitalized for atrial fibrillation, the frequency of off-label direct oral anticoagulant (DOAC) dosing, associated factors, hospital-level variation, and temporal trends in contemporary practice are unknown. METHODS: Using the Get With The Guidelines--Atrial Fibrillation registry, patients admitted from January 1, 2014, to March 31, 2020, and discharged on DOACs were stratified according to receipt of underdosing, overdosing, or recommended dosing. Factors associated with off-label dosing (defined as underdosing or overdosing) were identified using logistic regression. Median odds ratio (OR) and time-series analyses were used to assess hospital-level variation and temporal trends, respectively. RESULTS: Of 22 470 patients (70.1±12.1 years, 48.1% female, 82.5% White) prescribed a DOAC at discharge from hospitalization for atrial fibrillation (66% apixaban, 29% rivaroxaban, and 5% dabigatran), underdosing occurred among 2006 (8.9%), overdosing among 511 (2.3%), and recommended dosing among 19 953 (88.8%). The overall rate of offlabel dosing was 11.2%. Patient-related factors associated with off-label dose included age (underdosing: OR, 1.06 per 1-year increase [95% CI, 1.06--1.07]; overdosing: OR, 1.07 per 1-year increase [95% CI, 1.06--1.09]), dialysis dependence (underdosing: OR, 5.50 [95% CI, 3.76--8.05]; overdosing: OR, 5.47 [95% CI, 2.74--10.88]), female sex (overdosing: OR, 0.79 [95% CI, 0.63--0.99]), and weight (overdosing: OR, 0.96 per 1-kg increase [95% CI, 0.95--1.00]). Across hospitals, the adjusted median OR for off-label DOAC dose was 1.45 (95% CI, 1.34--1.65; underdosing: OR, 1.52 [95% CI, 1.39--1.76]; overdosing: OR, 1.32 [95% CI, 1.20--1.84]), indicating significant hospital-level variation. Over the study period, recommended dosing significantly increased over time (81.9%--90.9%; P<0.0001 for trend) with a corresponding decline in underdosing (14.4%--6.6%; P<0.0001 for trend) and overdosing (3.8%--2.5%; P=0.001 for trend). CONCLUSIONS: Over 1 in 10 patients hospitalized for atrial fibrillation are discharged on an off-label DOAC dose with significant variation across hospitals. While the proportion of patients receiving recommended dosing has significantly improved over time, opportunities to improve DOAC dosing persist. [ABSTRACT FROM AUTHOR]

Several medications that are proven to reduce cardiovascular events exist for individuals with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease, however they are substantially underused in clinical practice. Clinician, patient, and system-level barriers all contribute to these gaps in care; yet, there is a paucity of high quality, rigorous studies evaluating the role of interventions to increase utilization. The COORDINATE-Diabetes trial randomized 42 cardiology clinics across the United States to either a multifaceted, site-specific intervention focused on evidence-based care for patients with T2DM or standard of care. The multifaceted intervention comprised the development of an interdisciplinary care pathway for each clinic, audit-and-feedback tools and educational outreach, in addition to patient-facing tools. The primary outcome is the proportion of individuals with T2DM prescribed three key classes of evidence-based medications (high-intensity statin, angiotensin converting enzyme inhibitor or angiotensin receptor blocker, and either a sodium/glucose cotransporter-2 inhibitor (SGLT-2i) inhibitor or glucagon-like peptide 1 receptor agonist (GLP-1RA) and will be assessed at least 6 months after participant enrollment. COORDINATE-Diabetes aims to identify strategies that improve the implementation and adoption of evidence-based therapies. [ABSTRACT FROM AUTHOR]

Background: Appropriate use criteria (AUC) have been developed to promote the rational use of percutaneous coronary intervention (PCI) among clinicians and to provide benchmarking feedback to hospitals. The original AUC were published in 2012 and subsequently updated in 2017 to reflect emerging, contemporary evidence however the degree to which the updated guidance re-classifies PCI appropriateness is unknown.Methods: Elective PCI cases from March 1, 2018 until June 30, 2021 were identified from within the NCDR CathPCI database. PCI cases were classified as 'appropriate,' 'uncertain' or 'inappropriate' under 2012 AUC and 'appropriate,' 'may be appropriate' or 'rarely appropriate' under 2017 AUC; those with missing data elements were termed 'not mappable.' Groups that 'remained appropriate' (appropriate in both 2012 and 2017), 'became non-appropriate' ('appropriate' in 2012 but became either 'may be appropriate' or 'rarely appropriate in 2017) and 'became appropriate' ('appropriate' in 2017 but were 'uncertain' or 'inappropriate' in 2012) were descriptively compared. Concordance was assessed by calculation of Cohen's Kappa.Results: A total of 245,196 patients underwent elective PCI across 1669 centers. By 2012 AUC, 44% were classified 'appropriate,' 28% were 'uncertain' and 16% were 'inappropriate' compared with 2017 AUC which considered 34% 'appropriate', 56% may be 'appropriate' and 4% 'rarely appropriate'. Overall fair agreement was observed with a Kappa statistic of 0.40 (95%CI 0.396-0.403). Compared with PCI that 'remained appropriate' under the 2017 AUC, PCI that 'became non-appropriate' in 2017 were more likely to be asymptomatic, less likely to be on anti-anginals and less likely to have complex lesions. Compared with PCI that 'became non-appropriate', PCI that 'became appropriate' had a higher proportion of atypical and non-anginal symptoms and were less likely to have had positive functional tests. Procedural related outcomes were similar across all groups. A total of 29 429 PCI (12.0%) were not mappable by 2012 AUC while 16 077 (6.6%) were not mappable by 2017 AUC.Conclusions: In this contemporary analysis of patients undergoing PCI in the United States, only fair agreement between the 2012 and updated 2017 AUC was observed. While some of this reflects the intention of the updated guidance, the large proportion that were considered 'maybe appropriate' or who 'became non-appropriate' reflect the difficulties of documenting and implementing contemporary AUC guidance. [ABSTRACT FROM AUTHOR]

Background: It is unknown whether digital applications can improve guideline-directed medical therapy (GDMT) and outcomes in heart failure with reduced ejection fraction (HFrEF).Methods and Results: Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure trial (CONNECT-HF) included an optional, prospective ancillary study of a mobile health application among patients hospitalized due to HFrEF. Digital users were matched to nonusers from the usual-care group. Coprimary outcomes included change in opportunity-based composite HF quality scores and HF rehospitalization or all-cause mortality. Among 2431 patients offered digital applications across the United States, 1526 (63%) had limited digital access or insufficient data, 425 (17%) were digital users, and 480 (20%) declined use. Digital users were similar in age to those who declined use (mean 58 vs 60 years; P = 0.031). Digital users (n = 368) vs matched nonusers (n = 368) had improved composite HF quality scores (48.0% vs 43.6%; + 4.76% [3.27-6.24]; P = 0.001) and composite clinical outcomes (33.0% vs 39.6%; HR 0.76 [0.59-0.97]; P = 0.027).Conclusions: Among participants in the CONNECT-HF trial, use of digital applications was modest but was associated with higher HF quality-of-care scores, including use of GDMT and better clinical outcomes. Although cause and effect cannot be determined from this study, the application of technology to guide GDMT use and dosing among patients with HFrEF warrants further investigation. [ABSTRACT FROM AUTHOR]

Background: Health system-level interventions to improve use of guideline-directed medical therapy (GDMT) often fail in the acute care setting. We sought to identify factors associated with high performance in adoption of GDMT among health systems in CONNECT-HF.Methods and Results: Site-level composite quality scores were calculated at discharge and last follow-up. Site performance was defined as the average change in score from baseline to last follow-up and analyzed by performance tertile using a mixed-effects model with baseline performance as a fixed effect and site as a random effect. Among 150 randomized sites, the mean 12-month improvement in GDMT was 1.8% (-26.4% to 60.0%). Achievement of 50% or more of the target dose for angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, angiotensin receptor-neprilysin inhibitors, and beta-blockers at 12 months was modest, even at the highest performing sites (median 29.6% [23%, 41%] and 41.2% [29%, 50%]). Sites achieving higher GDMT scores had care teams that included social workers and pharmacists, as well as patients who were able to afford medications and access medication lists in the electronic health record.Conclusions: Substantial gaps in site-level use of GDMT were found, even among the highest performing sites. The failure of hospital-level interventions to improve quality metrics suggests that a team-based approach to care and improved patient access to medications are needed for postdischarge success. [ABSTRACT FROM AUTHOR]

Background: Despite multiple trials comparing rate with rhythm control, there is no consensus on the optimal management of first-detected atrial fibrillation (AF).Objective: We analyzed current patterns of care for first-detected AF in the nationwide Get With The Guidelines® - Atrial Fibrillation registry.Methods: Patients hospitalized with first-detected AF from 2013 to 2019 were included, and a descriptive analysis was performed comparing planned rate with rhythm control. Multivariable logistic regression analysis was performed to identify predictors for choosing rhythm over rate control.Results: Of the 86,759 patients with AF, 17.8% (15,473) had first-detected AF; 11,685 patients were included from 126 sites. Overall, 51.3% (5999) of patients were treated with rate control and 48.7% (5686) with rhythm control at admission. Patients with planned rhythm control had a shorter length of stay and were more likely to be discharged home than a facility. A higher percentage of patients with planned rhythm control were discharged on anticoagulation than those with planned rate control (75.6% vs 70.9%) despite a higher underlying stroke risk in the rate control group (higher median CHA2DS2-VASc score 4; Q1-Q3 2-5 for rate control vs 3; Q1-Q3 2-4 for rhyhtm control; P < .001). While Hispanic ethnicity, Medicaid insurance, age >70 years, and liver disease decreased the likelihood of rhythm control, factors such as heart failure, stroke, or prior bleeding diathesis had no association with the chosen treatment strategy.Conclusion: Less than half of the patients with first-detected AF receive rhythm control at admission. Given recent trial results, further studies should assess the long-term impact of rhythm control on patients' symptoms and quality of life, cardiovascular morbidity, and mortality. [ABSTRACT FROM AUTHOR]

The aims of this study were to describe trends and hospital variation in same-day discharge following elective percutaneous coronary intervention (PCI) and to evaluate the association between trends in same-day discharge and patient outcomes. Insights on contemporary use of same-day discharge following elective PCI are limited. In a sequential cross-sectional analysis of 819,091 patients undergoing elective PCI at 1,716 hospitals in the National Cardiovascular Data Registry CathPCI Registry from July 1, 2009, to December 31, 2017, overall and hospital-level trends in same-day discharge were assessed. Among the 212,369 patients who linked to Centers for Medicare and Medicaid Services data, the association between same-day discharge and 30-day mortality and rehospitalization was assessed. A total of 114,461 patients (14.0%) were discharged the same day as PCI. The proportion of patients with same-day discharge increased from 4.5% in the third quarter of 2009 to 28.6% in the fourth quarter of 2017. From 2009 to 2017, the rate of same-day discharge increased from 4.3% to 19.5% for femoral-access PCI and from 9.9% to 39.7% for radial-access PCI. Hospital-level variation in the use of same-day discharge persisted throughout (median odds ratio adjusted for year and radial access: 4.15). Risk-adjusted 30-day mortality did not change over time, while risk-adjusted rehospitalization decreased over time and more quickly for same-day discharge (P for interaction <0.001). In the past decade, a large increase in the use of same-day discharge following elective PCI was not associated with worse 30-day mortality or rehospitalization. Hospital-level variation in same-day discharge may represent an opportunity to reduce costs without compromising patient outcomes. [Display omitted] [ABSTRACT FROM AUTHOR]

The aims of this study were to examine rates of radial artery access in post–coronary artery bypass grafting (CABG) patients undergoing diagnostic catherization and/or percutaneous coronary intervention (PCI), whether operators with higher procedural volumes and higher percentage radial use were more likely to perform diagnostic catherization and/or PCI via the radial approach in post-CABG patients, and clinical and procedural outcomes in post-CABG patients who undergo diagnostic catherization and/or PCI via the radial or femoral approach. There are limited data comparing outcomes of patients with prior CABG undergoing transradial or transfemoral diagnostic catheterization and/or PCI. Using the National Cardiovascular Data Registry CathPCI Registry, all diagnostic catheterizations and PCIs performed in patients with prior CABG from July 1, 2009, to March 31, 2018 (n = 1,279,058, 1,173 sites) were evaluated. Temporal trends in transradial access were examined, and mortality, bleeding, vascular complications, and procedural metrics were compared between transradial and transfemoral access. The rate of transradial access increased from 1.4% to 18.7% over the study period. Transradial access was associated with decreased mortality (adjusted odds ratio [OR]: 0.83; 95% confidence interval [CI]: 0.75 to 0.91), decreased bleeding (OR: 0.57; 95% CI: 0.51 to 0.63), decreased vascular complications (OR: 0.38; 95% CI: 0.30 to 0.47), increased PCI procedural success (OR: 1.11; 95% CI: 1.06 to 1.16; p < 0.0001), and significantly decreased contrast volume across all procedure types. Transradial access was associated with shorter fluoroscopy time for PCI-only procedures but longer fluoroscopy time for diagnostic procedures plus ad hoc PCI and diagnostic procedures only. Operators with a higher rate of transradial access in non-CABG patients were more likely to perform transradial access in patients with prior CABG. The rate of transradial artery access in patients with prior CABG undergoing diagnostic catheterization and/or PCI has increased over the past decade in the United States, and it was more often performed by operators using a transradial approach in non-CABG patients. Compared with transfemoral access, transradial access was associated with improved clinical outcomes in patients with prior CABG. [Display omitted] [ABSTRACT FROM AUTHOR]

Many therapies have been shown to improve outcomes for patients with heart failure (HF) in controlled settings, but there are limited data available to inform best practices for hospital and post-discharge quality improvement initiatives. The CONNECT-HF study is a prospective, cluster-randomized trial of 161 hospitals in the United States with a 2×2 factorial design. The study is designed to assess the effect of a hospital and post-discharge quality improvement intervention compared with usual care (primary objective) on HF outcomes and quality-of-care, as well as to evaluate the effect of hospitals implementing a patient-level digital intervention compared with usual care (secondary objective). The hospital and post-discharge intervention includes audit and feedback on HF clinical process measures and outcomes for patients with HF with reduced ejection fraction (HFrEF) paired with education to sites and clinicians by a trained, nationally representative group of HF and quality improvement experts. The patient-level digital intervention is an optional ancillary study and includes a mobile application and behavioral tools that are intended to facilitate improved use of guideline-directed recommendations for self-monitoring and self-management of activity and medications for HFrEF. The effects of the interventions will be measured through an opportunity-based composite score on quality and time-to-first HF readmission or death among patients with HFrEF who present to study hospitals with acute HF and who consent to participate. The CONNECT-HF study is evaluating approaches for implementing HF guideline recommendations into practice and is one of the largest HF implementation science trials performed to date. [ABSTRACT FROM AUTHOR]

BACKGROUND: Advances in chronic total occlusion percutaneous coronary intervention (CTO PCI) techniques have led to increased procedural success rates among operators. While utilization of CTO PCI has disseminated widely, the learning curve for new operators has not been well-defined. METHODS: Between July 2009 and December 2015, 93 875 CTO PCI cases were extracted from the CathPCI Registry. We delineated a cohort of new CTO operators performing <10 CTO PCI cases per given year. In-hospital outcomes for subsequent CTO PCIs were stratified by the number of prior cases accrued by each operator. Multivariable regression models were used to estimate differences in outcomes with increasing experience. The primary outcome was major adverse cardiovascular events defined as the composite of death, myocardial infarction, stroke, tamponade, or urgent coronary artery bypass grafting. RESULTS: Among 70 916 cases performed by 7251 new operators, procedure success rate was 61.4% and major adverse cardiovascular event rate was 4.2%. Meanwhile, the rate of major bleeding was 4.0%, myocardial infarction 2.0%, mortality 0.6%, tamponade 0.3%, and renal failure 0.2%. Adjusted regression models demonstrated piecewise linear improvements in guidewire crossing, stent placement, and procedure success with accrued volume, albeit with increased contrast use, fluoroscopy time, and bleeding. Major adverse cardiovascular event rates were stable beyond the 12th case (odds ratio per 5 case increase 1.00; 95% CI, 0.98-1.03, P=0.7980). CONCLUSIONS: Among a large number of new CTO PCI operators in the United States, there exists an experiential learning curve for procedural success. However, there were higher rates of bleeding despite case experience, while major adverse cardiovascular events remained relatively unchanged after initiation. [ABSTRACT FROM AUTHOR]

Background: Low health literacy is common in the United States and may affect outcomes after myocardial infarction (MI). How often hospitals screen for low health literacy is unknown.Methods: We surveyed 122 hospitals in the TRANSLATE-ACS study and divided them into those that reported routinely (>75% of patients), selectively (1%-75%), or never (0%) screening MI patients for low health literacy prior to discharge. We performed logistic regression with random intercepts to compare 6-week and 6-month patient-reported medication adherence and multivariable Cox regression to compare 1-year major adverse cardiovascular events and all-cause readmission risks between hospital groups.Results: Overall, 25 (20.5%), 47 (38.5%), and 50 (41.0%) hospitals reported routinely, selectively, or never screening patients for low health literacy, respectively. Patients discharged from hospitals that routinely screened were more likely to report 6-week medication adherence [routinely: adjusted odds ratio (OR) 1.26, 95% CI 1.01-1.57; selectively: adjusted OR 1.19, 95% CI 1.00-1.43, both referenced to those discharged from hospitals that never screened]. Compared with hospitals that never screened health literacy, 1-year major adverse cardiovascular events were similar for hospitals that reported routinely screening (adjusted HR 0.92, 95% CI 0.75-1.14) or selectively screening (adjusted HR 1.01, 95% CI 0.84-1.21). Hospitals that reported selectively screening health literacy were associated with a lower adjusted risk of 1-year all-cause readmission (adjusted HR 0.89, 95% CI 0.79-1.00, P=.041).Conclusion: Only a minority of US hospitals routinely screen MI patients for low health literacy. Hospital screening was associated with higher medication adherence and lower readmission risk. Further investigation is needed to understand how inpatient screening can be implemented to improve longitudinal post-MI care. [ABSTRACT FROM AUTHOR]

Background--Patients with end-stage renal disease undergoing percutaneous coronary intervention (PCI) have largely been excluded from trials of antithrombotic therapies leaving little data to guide agent choice in this population. Methods and Results--The National Cardiovascular Data Registry CathPCI Registry was used to identify patients with end-stage renal disease undergoing PCI who received monotherapy with either bivalirudin or unfractionated heparin (UFH) (n=71 675). In hospital bleeding and mortality were compared and adjusted using the CathPCI Registry logistic regression models with generalized estimating equations with UFH as the reference. Bivalirudin was used in 51.3% of patients versus 48.7% for UFH. The use of bivalirudin decreased over time, and in 2014, UFH became the most frequently used. Patients receiving UFH were more likely to have an acute coronary syndrome presentation (37.8% versus 27.4%) or have cardiogenic shock (3.74% versus 1.98%). The observed rates for in hospital bleeding (7.0% versus 9.5%; adjusted odds ratio,0.82; 95% confidence interval, 0.76-0.87) and mortality (2.6% versus 4.2%; adjusted odds ratio, 0.87; 95% confidence interval, 0.78-0.97) were lower for patients receiving bivalirudin compared with those receiving UFH. Conclusions--In patients with end-stage renal disease undergoing PCI, bivalirudin and UFH were used with similar frequency although the patterns of use changed over the enrollment period. Patients with end-stage renal disease undergoing PCI had a lower adjusted risk of in hospital outcomes with bivalirudin; however, given the observational nature of this analysis, a randomized trial is warranted. [ABSTRACT FROM AUTHOR]

Objectives The study sought to define patient, operator, and institutional factors associated with transradial access (TRA) in ST-segment elevation myocardial infarction (STEMI) percutaneous coronary intervention (PCI), the variation in use across operators and institutions, and the relationship with mortality and bleeding. Background TRA for PCI in STEMI is underutilized. Factors associated with TRA are not well described, nor is there variation across operators and institutions or their relationship with outcomes. Methods The authors used hierarchical logistic regression to identify patient, operator, and institutional characteristics associated with TRA use as well as determine the variation in TRA for STEMI PCI from 2009 to 2015. They also described the relationship between operator- and institution-level use and risk-adjusted bleeding and mortality. Results Among 692,433 patients undergoing STEMI PCI, 12% (n = 82,618) utilized TRA. TRA increased from 2% to 23% from 2009 to 2015, but with significant geographic variation. Age, sex, cardiogenic shock, cardiac arrest, operators entering practice before 2012, and nonacademically affiliated institutions were associated with lower rates of TRA. There was significant operator and institutional variation, wherein identical patients would have >8-fold difference in odds of TRA for STEMI PCI by changing operators (median odds ratio: 8.7), and >5-fold difference by changing institutions (median odds ratio: 5.1). Greater TRA use across operators was associated with reduced bleeding (rho = −0.053), whereas TRA use across institutions was associated with reduced mortality (rho = −0.077). Conclusions Transradial access for STEMI PCI is increasing, but remains underutilized with significant geographic, operator, and institutional variation. These findings suggest an ongoing opportunity to standardize STEMI care. [ABSTRACT FROM AUTHOR]

: Clinicians caring for heart failure patients with reduced ejection fraction often fail to achieve optimal use of guideline-directed medical therapy (GDMT), which increases risk of readmission and/or death. Health system-level interventions have not consistently improved GDMT and factors associated with success in adopting GDMT are poorly defined. : Assess the relationship between hospital- and patient-level characteristics and health system performance on a composite score for GDMT at 12 months; and describe care delivery, care teams, and case mix associated with achieving optimal use of GDMT in practice. : Site-level composite quality scores were calculated at discharge and last or 12-monthvisit. Sites were characterized by performance using mean difference in quality composite score and were analyzed by performance tertile. Site performance prior to intervention was adjusted in the model as a fixed-effect. : Among 150 sites, median 12-month improvement in GDMT performance was zero (Figure). Achievement of >50% target dose for ACE/ARB/ARNI and beta-blockers was modest, even among site in the top tertile of performance (median 29.57 [23, 41]; and 41.18 [29, 50]. At top scoring sites care teams included social workers and pharmacists and patients could afford medications and access current medication lists in the electronic health record. : Substantial gaps in site-level use of GDMT were found even among top tertile sites participating in CONNECT-HF. Hospitals may be a key resource for health systems, but their ability to drive quality-based metrics for care delivery processes post-discharge in HF remains low. [ABSTRACT FROM AUTHOR]

Background: Percutaneous coronary intervention is performed by operators with differing experience, technique, and case mix. It is unknown if operator practice patterns impact patient outcomes. We sought to determine if a cluster algorithm can identify distinct profiles of percutaneous coronary intervention operators and if these profiles are associated with patient outcomes. Methods: Operators performing at least 25 annual procedures between 2014 and 2018 were clustered using an agglomerative hierarchical clustering algorithm. Risk-adjusted in-hospital mortality was compared between clusters. Results: We identified 4 practice profiles among 7706 operators performing 2 937 419 procedures. Cluster 1 (n=3345) demonstrated case mix and practice patterns similar to the national median. Cluster 2 (n=1993) treated patients with lower clinical acuity and were less likely to use intracoronary diagnostics, atherectomy, and radial access. Cluster 3 (n=1513) had the lowest case volume, were more likely to work at rural hospitals, and cared for a higher proportion of patients with ST-segment-elevation myocardial infarction and cardiogenic shock. Cluster 4 (n=855) had the highest case volume, were most likely to treat patients with high anatomic complexity and use atherectomy, intracoronary diagnostics, and mechanical support. Compared with cluster 1, adjusted in-hospital mortality was similar for cluster 2 (estimated difference, -0.03 [95% CI, -0.10 to 0.04]), higher for cluster 3 (0.14 [0.07-0.22]), and lower for cluster 4 (-0.15 [-0.24 to -0.06]). Conclusions: Distinct percutaneous coronary intervention operator profiles are differentially associated with patient outcomes. A phenotypic approach to physician assessment may provide actionable feedback for quality improvement. * Practice patterns of percutaneous coronary intervention operators in the United States vary regarding case mix and use of contemporary procedural techniques. * Differences in patient outcomes may be associated with operator factors such as case volume. * A novel machine-learning algorithm clusters percutaneous coronary intervention operators into 4 distinct profiles that differ by patient case mix and use of procedural techniques. * The cluster that most closely corresponds to proposed standards for optimal percutaneous coronary intervention practice-high annual volume, frequent use of contemporary procedural techniques, high clinical, and anatomic complexity-had the lowest adjusted in-hospital mortality rates. [ABSTRACT FROM AUTHOR]

For patients with heart failure (HF), the impact of the COVID-19 pandemic on care delivery and access to guideline-directed therapies known to reduce morbidity and mortality is largely unknown. To better understand how COVID-19 has affected HF care, we queried clinicians across the United States participating in the CONNECT-HF clinical trial. A survey was developed by expert consensus and sent to all CONNECT-HF site principal investigators. Descriptive statistics were used for the quantitative questions and content analysis was performed for free-text responses. Between 4/30/2020-5/13/2020, we received 83/149 responses (56% response rate), representing 83 unique HF programs from 32 states. The threshold for admitting patients to the hospital was unchanged for more than half of the respondents (n = 46/80, 57.5%). All programs experienced a decrease of in-person clinic visits (n = 82/82, 100%). A mean of 6827.9% of outpatient visits were converted to telehealth. Most programs reported routinely assessing guideline-directed medical therapy during telehealth visits (n = 70/74, 94.6%). Referrals were lower at some programs for cardiac rehabilitation (n = 49/77, 63.6%) and implantable cardioverter defibrillator (n = 17/75, 22.7%). Three themes emerged from free-text responses: 1) patients being fearful and reluctant to visit the hospital; 2) lower volume of HF admissions and inpatient census; and 3) most HF research activities have been halted. The care of patients with HF has been impacted by COVID-19 across the United States. There is a need for further evaluation of these changes, revised guidelines and protocols for telehealth care delivery, and efforts to address patients' fear of seeking care. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To examine the frequency and determinants of an assessment for rehabilitation during the hospitalization for acute stroke. Design: Prospective cohort of patients admitted with acute stroke in the Get With The Guidelines–Stroke (GWTG-Stroke) program from January 8, 2008, to March 31, 2011. Setting: Acute hospitals (n=1532) in the United States participating in the GWTG-Stroke program. Participants: Adults with a stroke diagnosis (N=616,982) from a GWTG-Stroke–participating acute hospital. Interventions: Not applicable. Main Outcome Measure: Documentation of an assessment for rehabilitation services during the acute hospitalization. Results: Overall, almost 90% of stroke patients had documentation of an acute assessment for rehabilitation. In multivariable analysis, patients significantly more likely to be assessed for rehabilitation were younger, male, black or of other nonwhite races (Asian, American Indian, Alaska Native, Native Hawaiian, or Pacific Islander) when compared with white, independently ambulating before admission, and admitted from the community. Patients who received a stroke consult, cared for in a stroke unit, and treated in the northeast region of the United States were also more likely to be assessed. Conclusions: There is evidence that rehabilitation was considered for 90% of acute stroke patients in this sample. Future research is needed to examine what assessments are conducted and by whom, and how these are used to determine the appropriate level of rehabilitation care for their needs. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To examine the frequency and determinants of an assessment for rehabilitation during the hospitalization for acute stroke. Design: Prospective cohort of patients admitted with acute stroke in the Get With The Guidelines–Stroke (GWTG-Stroke) program from January 8, 2008, to March 31, 2011. Setting: Acute hospitals (n=1532) in the United States participating in the GWTG-Stroke program. Participants: Adults with a stroke diagnosis (N=616,982) from a GWTG-Stroke–participating acute hospital. Interventions: Not applicable. Main Outcome Measure: Documentation of an assessment for rehabilitation services during the acute hospitalization. Results: Overall, almost 90% of stroke patients had documentation of an acute assessment for rehabilitation. In multivariable analysis, patients significantly more likely to be assessed for rehabilitation were younger, male, black or of other nonwhite races (Asian, American Indian, Alaska Native, Native Hawaiian, or Pacific Islander) when compared with white, independently ambulating before admission, and admitted from the community. Patients who received a stroke consult, cared for in a stroke unit, and treated in the northeast region of the United States were also more likely to be assessed. Conclusions: There is evidence that rehabilitation was considered for 90% of acute stroke patients in this sample. Future research is needed to examine what assessments are conducted and by whom, and how these are used to determine the appropriate level of rehabilitation care for their needs. [Copyright &y& Elsevier]

The article discusses the findings of the European Cooperative Acute Stroke Study (ECASS) III which established benefit to expanding the intravenous tissue-type plasminogen activator (tPA) window from 3 to 4.5 hours for patients suffering from acute ischemic stroke (AIS). It examines the use of tPA in clinical practice before and after publication of ECASS III in Get With The Guidelines (GWTG)-Stroke program, a national systems of care quality improvement initiative.

Objectives: The aim of this study was to describe differences in treatment and in-hospital mortality of early, late, and very late stent thrombosis (ST). Background: Early, late, and very late ST may differ in clinical presentation, management, and in-hospital outcomes. Methods: We analyzed definite (angiographically documented) ST cases identified from February 2009 to June 2010 in the CathPCI Registry. We stratified events by timing of presentation: early (≤1 month), late (1 to 12 months), or very late (≥12 months) following stent implantation. Multivariable logistic regression modeling was performed to compare in-hospital mortality for each type of ST after adjusting for baseline comorbidities. Results: During the study period, 7,315 ST events were identified in 7,079 of 401,662 patients (1.8%) presenting with acute coronary syndromes. This ST cohort consisted of 1,391 patients with early ST (19.6%), 1,370 with late ST (19.4%), and 4,318 with very late ST (61.0%). Subjects with early ST had a higher prevalence of black race and diabetes, whereas subjects with very late ST had a higher prevalence of white race and a lower prevalence of prior myocardial infarction or diabetes. In-hospital mortality was significantly higher in early ST (7.9%) compared with late (3.8%) and very late ST (3.6%, p < 0.001). This lower mortality for late and very late ST persisted after multivariable adjustment (odds ratio: 0.53 [95% confidence interval (CI): 0.36 to 0.79] and 0.58 [95% CI: 0.43 to 0.79], respectively). Conclusions: Significant differences exist in the presentation and outcomes of early, late, and very late ST. Among patients with acute coronary syndromes who are undergoing percutaneous coronary intervention for angiographically documented ST, early ST is associated with the highest in-hospital mortality. [Copyright &y& Elsevier]

The article discusses research on the use of and trends in evidence-based care acute myocardial infarction (AMI) processes and outcome in Asian-American and White patients in the U.S. The study made use of data from the Get With the Fuidelines-Coronary Arter Disease (GWTG-CAD) program of the American Heart Association (AHA). It found that Asian-Americans were less likely to undergo smoking cessation counseling.

To simultaneously adjust for confounding by multiple cardiovascular risk factors, recently published pharmacoepidemiologic studies have used an index of risk of cardiovascular disease (a cardiovascular risk score). This summary measure is a multivariate confounder score created from regression models relating these risk factors to the outcome. The score is then used in regression models to adjust for potential confounding of the exposure of interest. Although this summary score has a number of advantages, there is concern that it may result in underestimation of the standard error of the exposure estimate and thus inflate the number of statistically significant results.We conducted simulation studies comparing regression models adjusting for all risk factors directly to models using this summary risk score for large cohort studies.Results indicated that, as long as there was not a high degree of intercorrelation between the potential confounders and the exposure, estimated standard errors from the regression models using this summary risk score approximate their empirical standard errors well and are similar to the standard errors from the regression models directly adjusting for all risk factors.Based on these simulation results, using this summary risk score can be a reasonable approach for summarizing many risk factors in large cohort studies. [ABSTRACT FROM AUTHOR]

Background: Cost is frequently cited as a barrier to optimal medication use, but the extent to which copayment assistance interventions are used when available, and their impact on evidence-based medication persistence and major adverse cardiovascular events is unknown.Methods and Results: The ARTEMIS trial (Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) randomized 301 hospitals to usual care versus the ability to provide patients with vouchers that offset copayment costs when filling P2Y12 inhibitors in the 1 year post-myocardial infarction. In the intervention group, we used multivariable logistic regression to identify patient and medication cost characteristics associated with voucher use. We then used this model to stratify both intervention and usual care patients by likelihood of voucher use, and examined the impact of the voucher intervention on 1-year P2Y12 inhibitor persistence (no gap in pharmacy supply >30 days) and major adverse cardiovascular events (all-cause death, myocardial infarction, or stroke). Among 10 102 enrolled patients, 6135 patients were treated at hospitals randomized to the copayment intervention. Of these, 1742 (28.4%) never used the voucher, although 1729 (99.2%) voucher never-users filled at least one P2Y12 inhibitor prescription in the 1 year post-myocardial infarction. Characteristics most associated with voucher use included: discharge on ticagrelor, planned 1-year course of P2Y12 inhibitor treatment, white race, commercial insurance, and higher out-of-pocket medication costs (c-statistic 0.74). Applying this propensity model to stratify all enrolled patients by likelihood of voucher use, the intervention improved medication persistence the most in patients with high likelihood of voucher use (adjusted interaction P=0.03, odds ratio, 1.86 [95% CI, 1.48-2.33]). The intervention did not significantly reduce major adverse cardiovascular events in any voucher use likelihood group, although the odds ratio was lowest (0.86 [95% CI, 0.56-1.16]) among patients with high likelihood of voucher use (adjusted interaction P=0.04).Conclusions: Among patients discharged after myocardial infarction, those with higher copayments and greater out-of-pocket medication costs were more likely to use a copayment assistance voucher, but some classes of patients were less likely to use a copayment assistance voucher. Patients at low likelihood of voucher use benefitted least from copayment assistance, and other interventions may be needed to improve medication-taking behaviors and clinical outcomes in these patients. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02406677. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is available in the text. Background: Adjunctive coronary atherectomy (CA) can be utilized in treating severely calcified coronary lesions; however, the temporal trends, patient selection, and variation in use of CA have not been well described. We sought to assess the trends in usage, interhospital variability, and outcomes with CA among patients undergoing percutaneous coronary intervention (PCI). Methods: All patients undergoing PCI in the National Cardiovascular Data Registry CathPCI Registry from July 1, 2009 to December 31, 2016 (N=3 864 377) were analyzed based on utilization of either rotational or orbital CA. Intervals using date of index CA grouped into 2009 Q3 to 2010, 2011 to 2012, 2013 to 2014, and 2015 to 2016 and hospital-level quartiles based on annual CA volumes were evaluated. The primary outcome measure was in-hospital major adverse cardiac events defined as a composite of all-cause mortality, periprocedural myocardial infarction, or stroke. Independent variables associated with outcomes were determined. Results: CA represented 1.7% (n=65 033) of the total PCI volume. Among hospitals performing PCI (n=1672), 577 (34.5%) did not perform any CA. Patients treated with CA were elderly, more often male, and had a history of diabetes, prior myocardial infarction, PCI, and coronary artery bypass grafting. The utilization of CA increased from 1.1% in Q3 2009 to 3.0% in Q4 of 2016 (5% quarterly increase in odds of CA; OR [95% CI], 1.05 [1.04–1.06], P <0.001). Among patients undergoing CA, there was a temporal decline in major adverse cardiac events (0.98 [0.97–0.99], P <0.001) and myocardial infarction (0.97 [0.96–0.98], P <0.001). In adjusted analyses, increasing hospital CA volume was associated with lower mortality (0.85 [0.76–0.96], P =0.01) and lower rates of PCI failure or complication requiring coronary artery bypass grafting (0.67 [0.56–0.79], P <0.001) but was associated with small increase in coronary perforation (1.18 [1.04–1.35], P <0.01). Conclusions: Although CA is performed infrequently, its use has increased over time. After accounting for potential confounders, higher CA volume was associated with lower risk of major adverse events counterbalanced by small risk of coronary perforation. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is available in the text. Background: SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women), a randomized controlled trial comparing radial and femoral access in women undergoing cardiac catheterization or percutaneous coronary intervention (PCI), was terminated early for lower than expected event rates. Whether this was because of patient selection or better access site practice among trial patients is unknown. Methods and Results: SAFE-PCI was conducted within the National Cardiovascular Data Registry CathPCI registry. Using the National Cardiovascular Research Infrastructure Identification, PCI date, and age, patients enrolled in SAFE-PCI were compared with trial-eligible female CathPCI registry patients 1 year before, during, and 1 year after SAFE-PCI enrollment. Patient and procedure characteristics, predicted bleeding and mortality, and post-PCI bleeding were compared between groups. Enrolled SAFE-PCI patients and registry patients from the 3 time periods were linked to Centers for Medicare and Medicaid Services data to compare 30-day death and unplanned revascularization rates. At 54 SAFE-PCI sites, there were 496 SAFE-PCI trial patients with a PCI visit within the CathPCI registry. There were 24 958 registry patients from 1 year before and 1 year after SAFE-PCI enrollment and 15 904 trial-eligible registry patients during trial enrollment. Trial patients were younger, had lower predicted bleeding and mortality, and had lower rates of post-PCI bleeding within 72 hours compared with registry patients. Among 12 212 Centers for Medicare and Medicaid Services–linked patients, there were no significant differences in 30-day death and unplanned revascularization among the 4 groups. Conclusions: Lower predicted risk of bleeding and mortality among SAFE-PCI trial patients compared with registry patients suggests that lower-risk patients were selectively enrolled for the trial. These data demonstrate how registry-based randomized trials may offer methods for enrollment feedback to curb selection bias in recruitment. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01406236. [ABSTRACT FROM AUTHOR]