Achievement and quality measure attainment in patients hospitalized with atrial fibrillation: Results from The Get With The Guidelines - Atrial Fibrillation (GWTG-AFIB) registry.

BACKGROUND: The Get With The Guidelines - Atrial Fibrillation (GWTG-AFIB) Registry uses achievement and quality measures to improve the care of patients with atrial fibrillation (AF). We sought to evaluate overall and site-level variation in attainment of these measures among sites participating in the GWTG-AFIB Registry. METHODS: From the GWTG-AFIB registry, we included patients with AF admitted between 1/3/2013 and 6/30/2019. We described patient-level attainment and variation in attainment across sites of 6 achievement measures with 1) defect-free scores (percent of patients with all eligible measures attained), and 2) composite opportunity scores (percent of all eligible patient measures attained). We also described attainment of 11 quality measures at the patient-level. RESULTS: Among 80,951 patients hospitalized for AF (age 70±13 years, 47.0% female; CHA2DS2-VASc 3.6±1.8) at 132 sites. Site-level defect-free scores ranged from 4.7% to 85.8% (25th, 50th, 75th percentile: 32.7%, 52.1%, 64.4%). Composite opportunity scores ranged from 39.4% to 97.5% (25th, 50th, 75th: 68.1%, 80.3%, 87.1%). Attainment was notably low for the following quality measures: 1) aldosterone antagonist prescription when ejection fraction ≤35% (29% of those eligible); and 2) avoidance of antiplatelet therapy with OAC in patients without coronary/peripheral artery disease (81% of those eligible). CONCLUSIONS: Despite high overall attainment of care measures across GWTG-AFIB registry sites, large site variation was present with meaningful opportunities to improve AF care beyond OAC prescription, including but not limited to prescription of aldosterone antagonists in those with AF and systolic dysfunction and avoidance of non-indicated adjunctive antiplatelet therapy.

Rapid initiation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in acute and early HIV-1 infection: a DIAMOND subgroup analysis.

BACKGROUND: Treatment during acute or early human immunodeficiency virus (HIV)-1 infection is associated with immunologic and virologic benefits. OBJECTIVE: To evaluate darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) efficacy/safety among patients with acute or early HIV-1 infection who rapidly initiate treatment. METHODS: DIAMOND (ClinicalTrials.gov Identifier: NCT03227861), a phase 3 study, evaluated the efficacy/safety of D/C/F/TAF 800/150/200/10 mg in rapid initiation. Adults aged ≥18 years began D/C/F/TAF within 14 days of diagnosis, prior to the availability of screening/baseline laboratory results. In this subgroup analysis, virologic response (HIV-1 RNA <50 copies/mL) was assessed at Week 48 by intent-to-treat FDA snapshot (ITT-FDA snapshot) and observed (excluding patients with missing data) analyses in patients with acute (HIV-1 antibody negative and HIV-1 RNA positive/p24 positive) or early (HIV-1 antibody positive and suspected infection ≤6 months before screening/baseline) infection. RESULTS: Among 109 patients, 13 had acute and 43 had early HIV-1 infection. High rates of virologic response were demonstrated at Week 48 by ITT-FDA snapshot (acute: 10/13 [76.9%]; early: 37/43 [86.0%]) and observed (acute: 10/11 [90.9%]; early: 37/38 [97.4%]) analyses. No patients discontinued or required regimen change due to baseline resistance or lack of efficacy, or developed protocol-defined virologic failure. Through Week 48, 7 (53.8%) acute and 22 (51.2%) early infection patients had a D/C/F/TAF-related adverse event (AE); none had a D/C/F/TAF-related grade 4 or serious AE. CONCLUSIONS: High rates of viral suppression during acute/early infection were achieved with D/C/F/TAF rapid initiation, no treatment-emergent resistant mutations were observed, and D/C/F/TAF was safe and well tolerated.

Regional Variations in Heart Failure Quality and Outcomes: Get With The Guidelines-Heart Failure Registry.

Background Regional patient characteristics, care quality, and outcomes may differ based on a variety of factors among patients hospitalized for heart failure (HF). Regional disparities in outcomes of cardiovascular disease have been suggested across various regions in the United States. This study examined whether there are significant differences by region in quality of care and short-term outcomes of hospitalized patients with HF across the United States. Methods and Results We examined regional demographics, quality measures, and short-term outcomes across 4 US Census Bureau regions in patients hospitalized with HF and enrolled in the GWTG-HF (Get With The Guidelines-Heart Failure) registry from 2010 to 2016. Differences in length of stay and mortality by region were examined with multivariable logistic regression. The study included 423 333 patients hospitalized for HF in 488 hospitals. Patients in the Northeast were significantly older. Completion of achievement measures, with few exceptions, were met with similar frequency across regions. Multivariable analysis demonstrated significantly lower in-hospital mortality in the Midwest compared with the Northeast (hazard ratio, 0.64; 95% CI, 0.51-0.8; P<0.00001). The length of stay varied significantly by region with a significantly higher risk-adjusted length of stay in the Northeast compared with other regions. Conclusions Although we did not find any substantial differences by region in quality of care in patients hospitalized for HF, risk-adjusted inpatient mortality was found to be lower in the Midwest compared with the Northeast, and may be secondary to unmeasured differences in patient characteristics, and to longer length of stay in the Northeast.

Home Health Care Use and Post-Discharge Outcomes After Heart Failure Hospitalizations.

OBJECTIVES: This study compared the characteristics of Medicare beneficiaries who were hospitalized for heart failure (HF) and then discharged home who received home health care (HHC) to the characteristics of those who did not, and examined associations among HHC and readmission and mortality rates. BACKGROUND: After hospitalization for HF, some patients receive HHC. However, the use of HHC over time, the factors associated with its use, and the post-discharge outcomes after receiving it are not well studied. METHODS: This study used Get With The Guidelines-HF data, merged with Medicare fee-for-service claims. Propensity score matching and Cox proportional hazards models were used to evaluate the associations between HHC and post-discharge outcomes. RESULTS: From 2005 to 2015, 95,531 patients were admitted for HF, and 32,697 (34.2%) received HHC after discharge. The rate of HHC increased over time from 31.4% to 36.1% (p < 0.001). HHC recipients were older, more likely to be female, and had more comorbidities. HHC was associated with a higher risk of all-cause 30-day readmission (hazard ratio [HR]: 1.25; 95% confidence interval [CI]: 1.20 to 1.30), HF-specific 30-day readmission (HR: 1.20; 95% CI: 1.13 to 1.28), all-cause 90-day readmission (HR: 1.23; 95% CI: 1.19 to 1.26), HF-specific 90-day readmission (HR: 1.16; 95% CI: 1.11 to 1.22), and all-cause 30-and 90-day mortality, respectively (HR: 1.70; 95% CI: 1.56 to 1.86) and HR: 1.49; 95% CI: 1.41 to 1.57) compared to those who did not receive HHC. CONCLUSIONS: Use of HHC after HF hospitalization increased among Medicare beneficiaries. HHC recipients were older and sicker than non-HHC recipients. Although HHC was associated with a higher risk of readmissions and mortality, this finding should be interpreted cautiously, given the presence of unmeasured variables that could affect receipt of HHC. Research is needed to determine whether the results reflect appropriate health care use.

Strict Versus Lenient Versus Poor Rate Control Among Patients With Atrial Fibrillation and Heart Failure (from the Get With The Guidelines - Heart Failure Program).

Randomized data suggest lenient rate control (resting heart rate <110 beats/min) is noninferior to strict rate control (resting heart rate <80 beats/min) in patients with atrial fibrillation (AF). However, the optimal rate control strategy in patients with AF and heart failure (HF) remains unknown. Accordingly, we performed an observational analysis using data from the Get With The Guidelines-HF Program linked with Medicare data from July 1, 2011, to September 30, 2014. Of 13,981 patients with AF and HF, 9,100 (65.0%) had strict rate control, 4,617 (33.0%) had lenient rate control, and 264 (1.9%) had poor rate control by resting heart rate on the day of discharge. After multivariable adjustment, compared with strict rate control, lenient rate control was associated with higher adjusted risks of death (hazard ratio [HR] 1.21, 95% confidence interval [CI] 1.11 to 1.33, p <0.001), all-cause readmission (HR 1.09, 95% CI 1.03 to 1.15, p <0.002), death or all-cause readmission (HR 1.11, 95% CI 1.05 to 1.18, p <0.001), but not cardiovascular readmission (HR1.08, 95% CI 1.00 to 1.16, p = 0.051) at 90 days. Associations were comparable in patients with poor rate control and with heart rate modeled as a continuous variable. The presence or absence of reduced ejection fraction did not impact the magnitude of most observed associations. In conclusion, in patients with HF and AF, 2 of 3 patients had a heart rate that met strict-control goals at discharge. Heart rates >80 beats/min were associated with adverse outcomes irrespective of left ventricular ejection fraction.

Representativeness of a Heart Failure Trial by Race and Sex: Results From ASCEND-HF and GWTG-HF.

OBJECTIVES: This study sought to determine the degree to which U.S. patients enrolled in a heart failure (HF) trial represent patients in routine U.S. clinical practice according to race and sex. BACKGROUND: Black patients and women are frequently under-represented in HF clinical trials. However, the degree to which black patients and women enrolled in trials represent such patients in routine practice is unclear. METHODS: The ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial randomized patients hospitalized for HF to receive nesiritide or placebo from May 2007 to August 2010 and was neutral for clinical endpoints. This analysis compared non-Hispanic white (n = 1,494) and black (n = 1,012) patients enrolled in ASCEND-HF from the U.S. versus non-Hispanic white and black patients included in a U.S. hospitalized HF registry (i.e., Get With The Guidelines-Heart Failure [GWTG-HF]) during the ASCEND-HF enrollment period and meeting trial eligibility criteria. RESULTS: Among 79,291 white and black registry patients, 49,063 (62%) met trial eligibility criteria (white, n = 37,883 [77.2%]; black, n = 11,180 [22.8%]). Women represented 35% and 49% of the ASCEND-HF and trial-eligible GWTG-HF cohorts, respectively. Compared with trial-enrolled patients, trial-eligible GWTG-HF patients tended to be older with higher blood pressure and higher ejection fraction. Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (all p < 0.02), with consistent mortality findings by race and sex. After propensity score matching, mortality rates were similar; however, trial-eligible patients continued to have higher rates of 30-day readmission (23.1% vs. 17.3%; p < 0.01), driven by differences among black patients and women (all p for interaction ≤0.02). CONCLUSIONS: Patients with HF seen in U.S. practice and eligible for the ASCEND-HF trial had worse clinical outcomes than those enrolled in the trial. After accounting for clinical characteristics, trial-eligible real-world patients continued to have higher rates of 30-day readmission, driven by differences among black patients and women. Social, behavioral, and other unmeasured factors may impair representativeness of patients enrolled in HF trials, particularly among racial/ethnic minorities and women. (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure [ASCEND-HF]; NCT00475852).

Thrombolysis in young adults with stroke: Findings from Get With The Guidelines-Stroke.

OBJECTIVE: To determine whether young adults (≤40 years old) with acute ischemic stroke are less likely to receive IV tissue plasminogen activator (tPA) and more likely to have longer times to brain imaging and treatment. METHODS: We analyzed data from the Get With The Guidelines-Stroke registry for patients with acute ischemic stroke hospitalized between January 2009 and September 2015. We used multivariable models with generalized estimating equations to evaluate tPA treatment and outcomes between younger (age 18-40 years) and older (age >40 years) patients with acute ischemic stroke. RESULTS: Of 1,320,965 patients with acute ischemic stroke admitted to 1,983 hospitals, 2.3% (30,448) were 18 to 40 years of age. Among these patients, 12.5% received tPA vs 8.8% of those >40 years of age (adjusted odds ratio [aOR] 1.63, 95% confidence interval [CI] 1.56-1.71). However, younger patients were less likely to receive brain imaging within 25 minutes (62.5% vs 71.5%, aOR 0.78, 95% CI 0.73-0.84) and to be treated with tPA within 60 minutes of hospital arrival (37.0% vs 42.8%, aOR 0.74, 95% CI 0.68-0.79). Compared to older patients, younger patients treated with tPA had a lower symptomatic intracranial hemorrhage rate (1.7% vs 4.5%, aOR 0.55, 95% CI 0.42-0.72) and lower in-hospital mortality (2.0% vs 4.3%, aOR 0.65, 95% CI 0.52-0.81). CONCLUSIONS: In contrast to our hypothesis, younger patients with acute ischemic stroke were more likely to be treated with tPA than older patients, but they were more likely to experience delay in evaluation and treatment. Compared with older patients, younger patients had better outcomes, including fewer intracranial hemorrhages.

Effect of Catheter Ablation vs Medical Therapy on Quality of Life Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial.

Importance: Catheter ablation is more effective than drug therapy in restoring sinus rhythm in patients with atrial fibrillation (AF), but its incremental effect on long-term quality of life (QOL) is uncertain. Objective: To determine whether catheter ablation is more beneficial than conventional drug therapy for improving QOL in patients with AF. Design, Setting, and Participants: An open-label randomized clinical trial of catheter ablation vs drug therapy in 2204 symptomatic patients with AF older than 65 years or 65 years or younger with at least 1 risk factor for stroke. Patients were enrolled from November 2009 to April 2016 from 126 centers in 10 countries. Follow-up ended in December 2017. Interventions: Pulmonary vein isolation, with additional ablation procedures at the discretion of the investigators, for the catheter ablation group (n = 1108) and standard rhythm and/or rate-control drugs selected and managed by investigators for the drug therapy group (n = 1096). Main Outcomes and Measures: Prespecified co-primary QOL end points at 12 months, including the Atrial Fibrillation Effect on Quality of Life (AFEQT) summary score (range, 0-100; 0 indicates complete disability and 100 indicates no disability; patient-level clinically important difference, ≥5 points) and the Mayo AF-Specific Symptom Inventory (MAFSI) frequency score (range, 0-40; 0 indicates no symptoms and 40 indicates the most severe symptoms; patient-level clinically important difference, ≤-1.6 points) and severity score (range, 0-30; 0 indicates no symptoms and 30 indicates the most severe symptoms; patient-level clinically important difference, ≤-1.3 points). Results: Among 2204 randomized patients (median age, 68 years; 1385 patients [63%] were men, 946 [43%] had paroxysmal AF, and 1256 [57%] had persistent AF), the median follow-up was 48.5 months, and 1968 (89%) completed the trial. The mean AFEQT summary score was more favorable in the catheter ablation group than the drug therapy group at 12 months (86.4 points vs 80.9 points) (adjusted difference, 5.3 points [95% CI, 3.7-6.9]; P < .001). The mean MAFSI frequency score was more favorable for the catheter ablation group than the drug therapy group at 12 months (6.4 points vs 8.1 points) (adjusted difference, -1.7 points [95% CI, -2.3 to -1.2]; P < .001) and the mean MAFSI severity score was more favorable for the catheter ablation group than the drug therapy group at 12 months (5.0 points vs 6.5 points) (adjusted difference, -1.5 points [95% CI, -2.0 to -1.1]; P < .001). Conclusions and Relevance: Among patients with symptomatic atrial fibrillation, catheter ablation, compared with medical therapy, led to clinically important and significant improvements in quality of life at 12 months. These findings can help guide decisions regarding management of atrial fibrillation. Trial Registration: ClinicalTrials.gov Identifier: NCT00911508.

Use, Temporal Trends, and Outcomes of Endovascular Therapy After Interhospital Transfer in the United States.

BACKGROUND: The use of endovascular therapy (EVT) in patients with acute ischemic stroke who have large vessel occlusion has rapidly increased in the United States following pivotal trials demonstrating its benefit. Information about the contribution of interhospital transfer in improving access to EVT will help organize regional systems of stroke care. METHODS: We analyzed trends of transfer-in EVT from a cohort of 1 863 693 patients with ischemic stroke admitted to 2143 Get With The Guidelines-Stroke participating hospitals between January 2012 and December 2017. We further examined the association between arrival mode and in-hospital outcomes by using multivariable logistic regression models. RESULTS: Of the 37 260 patients who received EVT at 639 hospitals during the study period, 42.9% (15 975) arrived at the EVT-providing hospital after interhospital transfer. Transfer-in EVT cases increased from 256 in the first quarter 2012 to 1422 in the fourth quarter 2017, with sharply accelerated increases following the fourth quarter 2014 ( P<0.001 for change in linear trend). Transfer-in patients were younger and more likely to be of white race, to arrive during off-hours, and to be treated at comprehensive stroke centers. Transfer-in patients had significantly longer last-known-well-to-EVT initiation time (median, 289 minutes versus 213 minutes; absolute standardized difference, 67.33) but were more likely to have door-to-EVT initiation time of ≤90 minutes (65.6% versus 23.6%; absolute standardized difference, 93.18). In-hospital outcomes were worse for transfer-in patients undergoing EVT in unadjusted and in risk-adjusted models. Although the difference in in-hospital mortality disappeared after adjusting for delay in EVT initiation (14.7% versus 13.4%; adjusted odds ratio, 1.01; 95% CI, 0.92-1.11), transfer-in patients were still more likely to develop symptomatic intracranial hemorrhage (7.0% versus 5.7%; adjusted odds ratio, 1.15; 95% CI, 1.02-1.29) and less likely to have either independent ambulation at discharge (33.1% versus 37.1%; adjusted odds ratio, 0.87; 95% CI, 0.80-0.95) or to be discharged to home (24.3% versus 29.1%; adjusted odds ratio, 0.82; 95% CI, 0.76-0.88). CONCLUSIONS: Interhospital transfer for EVT is increasingly common and is associated with a significant delay in EVT initiation highlighting the need to develop more efficient stroke systems of care. Further evaluation to identify factors that impact EVT outcomes for transfer-in patients is warranted.

Characteristics of Acute Heart Failure Hospitalizations Based on Presenting Severity.

BACKGROUND: Hospitalizations for acute heart failure (HF) are significant events with downstream implications for patients, as well as healthcare systems and payers. However, from anecdotal experience, both hospitalization and postdischarge courses vary significantly based on severity of presenting decompensation. METHODS AND RESULTS: We compared patient and hospitalization characteristics, resource utilization, and associated outcomes, among modern era acute HF patients enrolled in the GWTG-HF (Get With the Guidelines-Heart Failure) registry between 2011 and 2016, by varying severity of their acute HF. Among over 165 000 hospitalizations included in our analysis, 2% were considered high-risk and 32% intermediate-risk for in-hospital mortality, similar to findings from 15 years prior. Further, the 1-year mortality rate was 40% among Medicare beneficiaries in GWTG-HF who survived to hospital discharge. CONCLUSIONS: The long-term outcomes among acute HF survivors remain poor and, in the context of an increasing HF burden, warrant further study of postdischarge management strategies including inpatient-to-clinic transitions and ambulatory HF systems-based care.

Glycated Hemoglobin and Outcomes of Heart Failure (from Get With the Guidelines-Heart Failure).

Glycated hemoglobin (HbA1C) is a risk factor for new onset heart failure (HF). There is however a paucity of data evaluating its association with outcomes in patients with established HF. We assessed the relation of HbA1C with outcomes among hospitalized HF patients. Among 41,776 HF patients from 263 hospitals participating to the Get with the Guidelines-HF registry between January 2009 and March 2016, we related HbA1C to outcomes (in-hospital mortality, length of hospital stay, discharge to home, 30-day mortality, 30-day readmission, and 1-year mortality), using generalized estimating equation to account for within-hospital clustering and potential confounders. There were 68% of HF patients with diabetes and median HbA1C was 7.1%. Each percent change in HbA1C was associated with higher odds of discharge to home for HbA1C levels <6.5% (covariate-adjusted odds ratio [OR] 1.13 [95% confidence interval 1.04 to 1.12]) or ≥6.5% (OR 1.05 [1.02 to 1.07]). After stratification by diabetes status, this association remained significant only among patients with diabetes (ORs for HbA1C levels <6.5%: 1.17 [1.07 to 1.27]; and ≥6.5%: 1.06 [1.03 to 1.09]). Compared with the lowest HbA1C tertile (HbA1C ≤6.1%), patients in the highest HbA1C tertile (HbA1C 7.3% to 19%) were more likely to have a length of hospital stay >4 days (OR 1.10 [1.02 to 1.18]) and to be discharged home (OR 1.23 [1.14 to 1.33]). There were no significant association between HbA1C and the following outcomes: in-hospital mortality, 30-day mortality, 30-day readmission, and 1-year mortality. In conclusion, among hospitalized HF patients, HbA1C was associated with prolonged hospital stay and home discharge, but not with readmission, short-term, or intermediate-term mortality.

Association of Kidney Function With 30-Day and 1-Year Poststroke Mortality and Hospital Readmission.

Background and Purpose- Kidney dysfunction is common among patients hospitalized for ischemic stroke. Understanding the association of kidney disease with poststroke outcomes is important to properly adjust for case mix in outcome studies, payment models and risk-standardized hospital readmission rates. Methods- In this cohort study of fee-for-service Medicare patients admitted with ischemic stroke to 1579 Get With The Guidelines-Stroke participating hospitals between 2009 and 2014, adjusted multivariable Cox proportional hazards models were used to determine the independent associations of estimated glomerular filtration rate (eGFR) and dialysis status with 30-day and 1-year postdischarge mortality and rehospitalizations. Results- Of 204 652 patients discharged alive (median age [25th-75th percentile] 80 years [73.0-86.0], 57.6% women, 79.8% white), 48.8% had an eGFR ≥60, 26.5% an eGFR 45 to 59, 16.3% an eGFR 30 to 44, 5.1% an eGFR 15 to 29, 0.6% an eGFR <15 without dialysis, and 2.8% were receiving dialysis. Compared with eGFR ≥60, and after adjusting for relevant variables, eGFR <45 was associated with increased 30-day mortality with the risk highest among those with eGFR <15 without dialysis (hazard ratio [HR], 2.09; 95% CI, 1.66-2.63). An eGFR <60 was associated with increased 1-year poststroke mortality that was highest among patients on dialysis (HR, 2.65; 95% CI, 2.49-2.81). Dialysis was also associated with the highest 30-day and 1-year rehospitalization rates (HR, 2.10; 95% CI, 1.95-2.26 and HR, 2.55; 95% CI, 2.44-2.66, respectively) and 30-day and 1-year composite of mortality and rehospitalization (HR, 2.04; 95% CI, 1.90-2.18 and HR, 2.46; 95% CI, 2.36-2.56, respectively). Conclusions- Within the first year after index hospitalization for ischemic stroke, eGFR and dialysis status on admission are associated with poststroke mortality and hospital readmissions. Kidney function should be included in risk-stratification models for poststroke outcomes.

Economic and Quality-of-Life Outcomes of Natriuretic Peptide-Guided Therapy for Heart Failure.

BACKGROUND: The GUIDE-IT (GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) trial prospectively compared the efficacy of an N-terminal pro-B-type natriuretic peptide (NT-proBNP)-guided heart failure treatment strategy (target NT-proBNP level <1,000 pg/ml) with optimal medical therapy alone in high-risk patients with heart failure and reduced ejection fraction. When the study was stopped for futility, 894 patients had been enrolled. OBJECTIVES: The purpose of this study was to assess treatment-related quality-of-life (QOL) and economic outcomes in the GUIDE-IT trial. METHODS: The authors prospectively collected a battery of QOL instruments at baseline and 3, 6, 12, and 24 months post-randomization (collection rates 90% to 99% of those eligible). The principal pre-specified QOL measures were the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score and the Duke Activity Status Index (DASI). Cost data were collected for 735 (97%) U.S. RESULTS: Baseline variables were well balanced in the 446 patients randomized to the NT-proBNP-guided therapy and 448 to usual care. Both the KCCQ and the DASI improved over the first 6 months, but no evidence was found for a strategy-related difference (mean difference [biomarker-guided - usual care] at 24 months of follow-up 2.0 for DASI [95% confidence interval (CI): -1.3 to 5.3] and 1.1 for KCCQ [95% CI: -3.7 to 5.9]). Total winsorized costs averaged $5,919 higher in the biomarker-guided strategy (95% CI: -$1,795, +$13,602) over 15-month median follow-up. CONCLUSIONS: A strategy of NT-proBNP-guided HF therapy had higher total costs and was not more effective than usual care in improving QOL outcomes in patients with heart failure and a reduced ejection fraction. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment [GUIDE-IT]; NCT01685840).

Shock Index Predicts Patient-Related Clinical Outcomes in Stroke.

Background The prognostic value of shock index ( SI ), heart rate divided by systolic blood pressure, in stroke for clinical outcomes other than mortality is not well understood. Methods and Results We examined the Get With The Guidelines-Stroke ( GWTG -Stroke) data to explore the usefulness of SI in predicting in-hospital outcomes in 425 808 acute stroke cases (mean age: 71.0±14.5 years; 48.8% male; 89.7% ischemic stroke and 10.3% intracerebral hemorrhage) admitted between October 2012 and March 2015. Compared with patients with SI of 0.5 to 0.7, patients with SI >0.7 (13.6% of the sample) had worse outcomes, with adjusted odds ratios of 2.00 (95% confidence interval [ CI ], 1.92-2.08) for in-hospital mortality, 1.46 (95% CI , 1.43-1.49) for longer length of hospital stay >4 days, 1.50 (95% CI , 1.47-1.54) for discharge destination other than home, 1.41 (95% CI , 1.38-1.45) for inability to ambulate independently at discharge, and 1.52 (95% CI , 1.47-1.57) for modified Rankin Scale score of 3 to 6 at discharge. Results were similar when analyses were confined to those with available National Institutes of Health Stroke Scale (NIHSS) or within individual stroke subtypes or when SI was additionally included in the models with or without blood pressure components. Every 0.1 increase in SI >0.5 was associated with significantly worse outcomes in linear spline models. The addition of SI to existing GWTG -Stroke mortality prediction models without NIHSS demonstrated modest improvement, but little to no improvement was noted in models with NIHSS . Conclusions SI calculated at the point of care may be a useful prognostic indicator to identify those with high risk of poor outcomes in acute stroke, especially in hospitals with limited experience with NIHSS assessment.

Association of Electronic Health Record Use With Quality of Care and Outcomes in Heart Failure: An Analysis of Get With The Guidelines-Heart Failure.

BACKGROUND: Adoption of electronic health record (EHR) systems has increased significantly across the nation. Whether EHR use has translated into improved quality of care and outcomes in heart failure (HF) is not well studied. METHODS AND RESULTS: We examined participants from the Get With The Guidelines-HF registry who were admitted with HF in 2008 (N=21 222), using various degrees of EHR implementation (no EHR, partial EHR, and full EHR). We performed multivariable logistic regression to determine the relation between EHR status and several in-hospital quality metrics and outcomes. In a substudy of Medicare participants (N=8421), we assessed the relation between EHR status and rates of 30-day mortality, readmission, and a composite outcome. In the cohort, the mean age was 71±15 years, 49% were women, and 64% were white. The mean ejection fraction was 39±17%. Participants were admitted to hospitals with no EHR (N=1484), partial EHR (N=13 473), and full EHR (N=6265). There was no association between EHR status and several quality metrics (aside from ß blocker at discharge) or in-hospital outcomes on multivariable adjusted logistic regression (P>0.05 for all comparisons). In the Medicare cohort, there was no association between EHR status and 30-day mortality, readmission, or the combined outcome. CONCLUSIONS: In a large registry of hospitalized patients with HF, there was no association between degrees of EHR implementation and several quality metrics and 30-day postdischarge death or readmission. Our results suggest that EHR may not be sufficient to improve HF quality or related outcomes.

Dofetilide dose reductions and discontinuations in women compared with men.

BACKGROUND: Compared with men, women have longer corrected QT (QTc) intervals, lower clearance of dofetilide, and higher rates of drug-induced torsades de pointes, but the dofetilide dosing algorithm is the same for men and women. OBJECTIVE: The purpose of this study was to evaluate the tolerability of the 500 µg twice daily dose of dofetilide for men and women. METHODS: Men and women admitted to Duke University Medical Center (January 1, 2006, to October 19, 2012) for the initiation of dofetilide 500 µg twice daily were matched 1:1 on age and estimated creatinine clearance. Electrocardiograms throughout dosing were analyzed, and rates of dofetilide discontinuations and dose reductions were compared in unadjusted and adjusted analyses. RESULTS: For 220 matched men and women, the median age was 62.5 years (interquartile range 55-69 years) and the median eCrCl was 98.1 mL/min (interquartile range 77.6-126.2 mL/min). Women were less likely than men to have hypertension and interventricular conduction delay but were otherwise similar. During dofetilide initiation, women were more likely than men to have their dofetilide dose discontinued or reduced (55% vs 32%; P < .001). In most women (82%) and men (69%), the reason for dose adjustment was significant QTc prolongation. In the adjusted analysis, female sex was associated with higher rates of dofetilide dose discontinuations or reductions (odds ratio 3.01; 95% confidence interval 1.58-5.71; P < .01). CONCLUSION: More than half of women who initiated on 500 µg twice daily of dofetilide required medication discontinuations or dose reductions, mostly because of QTc prolongation. Additional studies are needed to evaluate the optimal dosing algorithm of dofetilide in women.

Economic Analysis of Apixaban Therapy for Patients With Atrial Fibrillation From a US Perspective: Results From the ARISTOTLE Randomized Clinical Trial.

Importance: The Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial reported that apixaban therapy was superior to warfarin therapy in preventing stroke and all-cause death while causing significantly fewer major bleeds. To establish the value proposition of substituting apixiban therapy for warfarin therapy in patients with atrial fibrillation, we performed a cost-effectiveness analysis using patient-level data from the ARISTOTLE trial. Objective: To assess the cost and cost-effectiveness of apixaban therapy compared with warfarin therapy in patients with atrial fibrillation from the perspective of the US health care system. Design, Setting, and Participants: This economic analysis uses patient-level resource use and clinical data collected in the ARISTOTLE trial, a multinational randomized clinical trial that observed 18 201 patients (3417 US patients) for a median of 1.8 years between 2006 and 2011. Interventions: Apixaban therapy vs warfarin therapy. Main Outcomes and Measures: Within-trial resource use and cost were compared between treatments, using externally derived US cost weights. Life expectancies for US patients were estimated according to their baseline risk and treatment using time-based and age-based survival models developed using the overall ARISTOTLE population. Quality-of-life adjustment factors were obtained from external sources. Cost-effectiveness (incremental cost per quality-adjusted life-year gained) was evaluated from a US perspective, and extensive sensitivity analyses were performed. Results: Of the 3417 US patients enrolled in ARISTOTLE, the mean (SD) age was 71 (10) years; 2329 (68.2%) were male and 3264 (95.5%) were white. After 2 years of anticoagulation therapy, health care costs (excluding the study drug) of patients treated with apixaban therapy and warfarin therapy were not statistically different (difference, -$60; 95% CI, -$2728 to $2608). Life expectancy, modeled from ARISTOTLE outcomes, was significantly longer with apixaban therapy vs warfarin therapy (7.94 vs 7.54 quality-adjusted life years). The incremental cost, including cost of anticoagulant and monitoring, of achieving these benefits was within accepted US norms ($53 925 per quality-adjusted life year, with 98% likelihood of meeting a $100 000 willingness-to-pay threshold). Results were generally consistent when model assumptions were varied, with lifetime cost-effectiveness most affected by the price of apixaban and the time horizon. Conclusions and Relevance: Apixaban therapy for ARISTOTLE-eligible patients with atrial fibrillation provides clinical benefits at an incremental cost that represents reasonable value for money judged using US benchmarks for cost-effectiveness. Trial Registration: clinicaltrials.gov Identifier: NCT00412984.

Delays in Door-to-Needle Times and Their Impact on Treatment Time and Outcomes in Get With The Guidelines-Stroke.

BACKGROUND AND PURPOSE: Despite quality improvement programs such as the American Heart Association/American Stroke Association Target Stroke initiative, a substantial portion of acute ischemic stroke patients are still treated with tissue-type plasminogen activator (alteplase) later than 60 minutes from arrival. This study aims to describe the documented reasons for delays and the associations between reasons for delays and patient outcomes. METHODS: We analyzed the characteristics of 55 296 patients who received intravenous alteplase in 1422 hospitals participating in Get With The Guidelines-Stroke from October 2012 to April 2015, excluding transferred patients and inpatient strokes. We assessed eligibility, medical, and hospital reasons for delays in door-to-needle time. RESULTS: There were 27 778 patients (50.2%) treated within 60 minutes, 10 086 patients (18.2%) treated >60 minutes without documented delays, and 17 432 patients (31.5%) treated >60 minutes with one or more documented reasons for delay. Delayed door-to-needle times were associated with delayed diagnosis (36 minutes longer than those without delay in diagnosis) and hypoglycemia or seizure (34 minutes longer than without those conditions). The presence of documented delays was associated with higher odds of in-hospital mortality (odds ratio, 1.2; 95% confidence interval, 1.1-1.3) and symptomatic intracranial hemorrhage (odds ratio, 1.2; 95% confidence interval, 1.1-1.3) and lower odds of independent ambulation at discharge (odds ratio, 0.92; 95% confidence interval, 0.9-1.0) after adjusting for patient and hospital characteristics. CONCLUSIONS: Hospital and eligibility delays such as delay diagnosis and inability to determine eligibility were associated with longer door-to-needle times. Improved stroke recognition and management of acute comorbidities may help to reduce door-to-needle times.

Prescription of Guideline-Recommended Implantable Cardioverter Defibrillator and Cardiac Resynchronization Therapy Among Patients Hospitalized With Heart Failure and Varying Degrees of Renal Function.

Implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) reduce mortality in many patients with heart failure (HF), but the current use and effectiveness of ICD/CRT in patients with chronic kidney disease (CKD) are uncertain. We examined associations between kidney function and guideline-recommended prescription of ICD/CRT in the Get With The Guidelines-Heart Failure registry, a performance improvement program for hospitalized patients with HF. We compared differences in ICD and CRT prescription between the following categories of estimated glomerular filtration rate (eGFR; mL/min/1.73 m2): ≥60, 59 to 30, <30, and dialysis dependent. From 2008 through 2014, 26,286 patients were eligible for ICD or CRT, and 16,123(61%) had an eGFR <60. De novo ICD and CRT prescription in this group was low at 45% and 30.5%, respectively. Compared to patients with eGFR ≥60, patients with eGFR 30 to 59 were more likely to receive an ICD (adjusted odds ratio [aOR] 1.08, 95% confidence intervals [CI] 1.01 to 1.14), whereas dialysis patients were less likely (aOR 0.61, 95% CI 0.5 to 0.76). Worse kidney function was associated with a decreased likelihood of CRT prescription (aOR 0.97 per 10 ml/min eGFR decrease, p = 0.03). During the study period, the likelihood of both ICD and CRT prescription increased over time among patients with CKD (ICD aOR 1.12, 95% CI 1.07 to 1.18; CRT aOR 1.14, 95% CI 1.06 to 1.23, per year). Prescription of an ICT/CRT was associated with greater 1-year survival in all eGFR groups. In conclusion, there are significant CKD-based differences in prescription of ICD and CRT in HF. However, given the current state of evidence, it is unclear whether improved prescription of ICD and CRT in the CKD population will result in improvement in outcomes.

Factors Associated With and Prognostic Implications of Cardiac Troponin Elevation in Decompensated Heart Failure With Preserved Ejection Fraction: Findings From the American Heart Association Get With The Guidelines-Heart Failure Program.

Importance: Elevated levels of cardiac troponins are associated with adverse clinical outcomes among patients with heart failure (HF) and reduced ejection fraction. However, the clinical significance of troponin elevation in the setting of decompensated HF with preserved ejection fraction (HFpEF) is not well established. Objective: To determine the clinical predictors of troponin elevation and its association with in-hospital and long-term outcomes among patients with decompensated HFpEF. Design, Setting, and Participants: Observational analysis of Get With The Guidelines-HF registry participants who were admitted for decompensated HFpEF (ejection fraction ≥50%) from January 2009 through December 2014 and who had quantitative or categorical (elevated vs normal based on institution's reference laboratory) measures of troponin level (troponin T or troponin I, as available). Main Outcomes and Measures: In-hospital outcomes (mortality, length of stay, and discharge destination) and postdischarge outcomes (30-day mortality, 30-day readmission rate, 1-year mortality). Results: We included 34 233 patients with HFpEF from 224 sites with measured troponin levels (33.4% men; median age, 79 years): 78.6% (n = 26 896) with troponin I and 21.4% (n = 7319) with troponin T measurements. Among these, 22.6% (n = 7732) had elevation in troponin levels. In adjusted analysis, higher serum creatinine level, black race, older age, and ischemic heart disease were associated with troponin elevation. Elevated troponin was associated with higher odds of in-hospital mortality (odds ratio [OR], 2.19; 95% CI, 1.88-2.56), greater length of stay (length of stay >4 days OR, 1.38; 95% CI, 1.29-1.47), and lower likelihood of discharge to home (OR, 0.65; 95% CI, 0.61-0.71) independent of other clinical predictors and measured confounders. Presence of elevated troponin I levels was also significantly associated with increased risk of 30-day mortality (hazard ratio [HR], 1.59; 95% CI, 1.42-1.80), 30-day all-cause readmission (HR, 1.12; 95% CI, 1.01-1.25), and 1-year mortality HR, 1.35; 95% CI, 1.26-1.45). Conclusions and Relevance: Troponin elevation among patients with acutely decompensated HFpEF is associated with worse in-hospital and postdischarge outcomes, independent of other predictive variables. Future studies are needed to determine if measurement of troponin levels among patients with decompensated HFpEF may be useful for risk stratification.