Background Although multiple therapies have been shown to lower mortality in patients with heart failure (HF) and reduced left ventricular ejection fraction, their application in clinical practice ...has been less than ideal. To date, empiric estimation of the potential benefits that could be gained from eliminating these existing treatment gaps with optimal implementation has not been quantified. Methods Eligibility criteria for each evidence-based HF therapy, the estimated frequency of use/nonuse of specific treatments, the case fatality rates, and the risk reductions due to treatment were obtained from published sources. The numbers of deaths prevented or postponed because of each guideline-recommended therapy and overall were determined. Results Among patients with HF with reduced left ventricular ejection fraction in the United States (n = 2,644,800), the number eligible but not currently treated ranged from 139,749 for hydralazine/isorbide dinitrate to 852,512 for implantable cardioverter defibrillators. The comparative number of deaths that could potentially be prevented per year with optimal implementation of angiotensin-converting enzyme inhibitor/angiotensin receptor antagonist is 6,516; β-blockers, 12,922; aldosterone antagonists, 21,407; hydralazine/isorbide dinitrate, 6,655; cardiac resynchronization therapy, 8,317; and implantable cardioverter defibrillators, 12,179. If these treatment benefits were additive, optimal implementation of all 6 therapies could potentially prevent 67,996 deaths a year. Conclusions A substantial number of HF deaths in this country could potentially be prevented by optimal implementation of evidence-based therapies. These data may underscore the importance of performance improvement efforts to translate evidence-based therapy to routine clinical practice so as to reduce contemporary HF mortality.
Since the introduction of percutaneous coronary intervention (PCI) in 1977 by Andreas Gruntzig (1), the presence of cardiac surgery backup on site has been a recommended practice to treat the ...potential of life-threatening complications. ...there are few large studies that have directly compared the procedural outcomes of both primary and elective PCI at facilities without cardiac surgery on site with those that have traditional surgery on site (16-18). Because of the conflicting literature on this subject, the American College of Cardiology (ACC), American Heart Association (AHA), and Society for Cardiovascular Angiography and Interventions (SCAI) 2005 PCI guidelines continue to designate primary PCI a Class IIb indication (may be considered), and elective PCI a Class III indication (not recommended) when performed at facilities without surgical backup on site (19).
Background Get With The Guidelines (GWTG)-Stroke is a national stroke registry and quality improvement program. We examined the accuracy and reliability of data entered in GWTG-Stroke. Methods Data ...entered by sites in the GWTG-Stroke database were compared with that abstracted from de-identified medical records by trained auditors. Accuracy for each individual data element and a composite accuracy measure were calculated. Reliability was assessed using kappa ( κ ) statistics for categorical variables and intraclass correlation (ICC) for continuous variables. Results A random selection of 438 medical records from 147 GWTG-Stroke hospitals was obtained. Overall accuracy was above 90% for all variables abstracted except for weight (84.9%), serum creatinine (88.1%), deep venous thrombosis prophylaxis (79.0%), and date/time last known well (85.3%). Intermediate to good ( κ or ICC 0.40-0.75) or excellent agreement ( κ or ICC ≥0.75) was observed for nearly all audited variables, including time-related performance measures such as arrival within 2 hours of symptom onset ( κ = 0.90) and door-to-needle time ≤60 minutes ( κ = 0.72). The overall composite accuracy rate was 96.1%. The composite measure varied slightly by region and hospital academic status, but there were no significant differences in composite accuracy by bed size, ischemic stroke volume, primary stroke center certification, or Coverdell Registry participation. Conclusions This audit establishes the reliability of GWTG-Stroke registry data. Individual data elements with suboptimal accuracy should be targeted for further data quality improvement.
Background While there is an increasing emphasis on both optimizing quality of care and reducing health care costs, there are limited data regarding how to best achieve these goals for common and ...resource-intense conditions such as congenital heart disease. We evaluated excess costs associated with complications and prolonged length of stay (LOS) after congenital heart surgery in a large multicenter cohort. Methods Clinical data from The Society of Thoracic Surgeons Database were linked to estimated costs from the Pediatric Health Information Systems Database (2006 to 2010). Excess cost per case associated with complications and prolonged LOS was modeled for 9 operations of varying complexity adjusting for patient baseline characteristics. Results Of 12,718 included operations (27 centers), average excess cost per case in those with any complication (versus none) was $56,584 (+$132,483 for major complications). The 5 highest cost complications were tracheostomy, mechanical circulatory support, respiratory complications, renal failure, and unplanned reoperation or reintervention (ranging from $57,137 to $179,350). Patients with an additional day of LOS above the median had an average excess cost per case of $19,273 (+$40,688 for LOS 4 to 7 days above median). Potential cost savings in the study cohort achievable through reducing major complications (by 10%) and LOS (by 1 to 3 days) were greatest for the Norwood operation ($7,944,128 and $3,929,351, respectively) and several other commonly performed operations of more moderate complexity. Conclusions Complications and prolonged LOS after congenital heart surgery are associated with significant costs. Initiatives able to achieve even modest reductions in these morbidities may lead to both improved outcomes and cost savings across both moderate and high complexity operations.
Background Acquired thrombocytopenia after a non–ST-segment-elevation-acute coronary syndrome (NSTE-ACS) has been associated with increased in-hospital mortality and hemorrhagic complications, but ...longer term outcomes are unclear. We examined the association between thrombocytopenia and long-term outcomes after accounting for thrombocytopenia severity and discharge medication use. Methods Data from 7,435 NSTE-ACS patients enrolled in the SYNERGY trial were analyzed. Severe thrombocytopenia was defined as a nadir platelet count <100 × 109 /L or a ≥50% drop from baseline. Mild thrombocytopenia was defined as a nadir platelet count between 100 and 149 × 109 /L with a <50% drop from baseline. The primary outcomes of interest were in-hospital GUSTO moderate-severe bleeding and 1-year mortality. Results Overall, 675 patients (9.1%) developed mild thrombocytopenia and 139 patients (1.9%) developed severe thrombocytopenia. In-hospital bleeding risks were higher in patients with mild (7.7%, adjusted HR 1.63, 95% CI 1.16-2.29) or severe (28.2%, adjusted HR 6.93, 95% CI 4.55-10.56) thrombocytopenia than in patients without thrombocytopenia (5.2%). One-year mortality rates were 6.5%, 8.1%, and 28.1% among patients with no, mild, and severe thrombocytopenia, respectively (log rank P < 0.001) but only severe thrombocytopenia remained significantly associated with increased mortality after adjustment: HR 4.07, 95% CI 2.86–5.78. Patients who developed severe thrombocytopenia were less likely to be discharged on guideline-recommended antiplatelet therapy. The relationship between severe thrombocytopenia and mortality was attenuated by but persisted after adjusting for discharge medication use (HR 2.83, 95% CI 1.49-5.38). Conclusions Thrombocytopenia occurs commonly during the course of NSTE-ACS care; even mild decreases are associated with clinically meaningful bleeding. Patients who developed severe thrombocytopenia were less likely to be discharged on guideline-recommended antiplatelet therapy; this may contribute to their higher associated long-term mortality.
Background Several non–vitamin K antagonist oral anticoagulant (NOAC) alternatives to warfarin are available for stroke prevention in atrial fibrillation (AF). We aimed to describe the factors ...associated with selection of NOACs versus warfarin in patients with new onset AF. Methods The ORBIT-AF II study is a national, US, prospective, observational, cohort study of anticoagulation treatment in patients with AF receiving NOACs or warfarin in the United States from 2013 to 2016. We measured factors associated with oral anticoagulant selection in 4,670 patients recently diagnosed with AF. Results At baseline, 1,169 (25%) patients were started on warfarin and 3,501 (75%) on NOACs: of these latter, 259 (6%) were started on dabigatran, 1858 (40%) on rivaroxaban, and 1384 (30%) on apixaban. Those receiving NOACs were slightly younger patients (median age 71 vs 72, P < .0001); were less likely to have prior stroke (5.3% vs 8.6%; P < .0001) or prior bleeding (2.7% vs 4.4%; P = .005); had better kidney function (mean estimated glomerular filtration rate 91 mL/min vs 80 mL/min, P < .0001); and had fewer patients at high stroke risk (CHA2 DS2 -VASc score Congestive heart failure, Hypertension, Age ≥ 75 years, Diabetes mellitus, Prior stroke, transient ischemic attack {TIA}, or thromboembolism,Vascular disease, Age 65–74 years, Sex category {female} ≥ 2 in 86% vs 93%; P < .0001). In multivariable analysis, factors associated with NOAC selection versus warfarin included renal function, prior stroke or valve replacement, rhythm control AF management strategy, treatment by a cardiologist, and higher patient education level. Conclusions In contemporary clinical practice, up to three-fourths of patients with new-onset AF are now initially treated with a NOAC for stroke prevention. Those selected for NOAC treatment had lower stroke and bleeding risk profiles, were more likely treated by cardiologists, and had higher socioeconomic status. Trial registration clinicaltrials.gov Identifier: NCT01701817
Abstract Background As treatment options for atrial fibrillation (AF) increase, more attention is focused on patients' experiences and quality of life (QoL). However, little is known about the ...factors associated with these outcomes. Methods The Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) is a disease-specific QoL tool for AF, with domain and summary scores ranging from 0 (the worst QoL) to 100. Using multivariable linear regression, we evaluated factors associated with baseline AFEQT Summary and Subscale Scores in ORBIT AF, a large, community-based AF registry. Independent associations were reported as coefficient estimates in scores and 95% confidence intervals (CI). Results Overall, AFEQT was assessed in 2007 AF outpatients from 99 sites. Median age (IQR) was 76 years (67–82) and 43% were female. The median AFEQT summary score was 82 (67–94). Female sex, younger age, new onset AF, higher heart rate, obstructive sleep apnea, symptomatic heart failure (HF), chronic obstructive pulmonary disease and coronary artery disease were all independently associated with reduced QoL. Female sex Estimate −7.03, 95% CI (−9.31, −4.75) and new onset versus permanent AF Estimate −7.44, 95% CI (−11.03, −3.84) were independently associated with increased symptoms. NYHA Class III or IV HF Estimate −14.44, 95% CI (−19.46, −8.76) and female sex Estimate −7.91, 95% CI (−9.95, −5.88) were most independently associated with impaired daily activities. Conclusions QoL in patients with AF varies widely and is associated with several patient factors. Understanding patient factors independently associated with worse QoL can be a foundation for tailoring treatment.
Abstract Objectives The purpose of this study was to determine the significant clinical predictors of incident heart failure (HF) and its prognostic effect on long-term outcomes among community-based ...patients with established atrial fibrillation (AF). Background AF is associated with an increased risk of HF. However, in this population, little focus is placed on risk stratification for and the prevention of HF. Methods Patients with AF but without HF at baseline enrolled in the ORBIT-AF (Outcomes Registry for Informed Treatment of Atrial Fibrillation) registry were included. Separate multivariable-adjusted Cox frailty regression models were used to identify significant predictors of HF incidence and determine the associated risk of adverse clinical events. Results The study included 6,545 participants with AF from 173 participating sites. Incident HF developed in 236 participants (3.6%) over the 2-year follow-up period; ejection fraction was preserved (>40%) in 64%, reduced (≤40%) in 13.5%, and missing in 22.5%. In multivariable analysis, traditional HF risk factors (age, coronary artery disease, renal dysfunction, and valvular disease), presence of permanent AF (hazard ratio HR: 1.60 95% confidence interval (CI): 1.18 to 2.16; reference group: paroxysmal AF), and elevated baseline heart rate (HR: 1.07 95% CI: 1.02 to 1.13 per 5 beats/min higher heart rate) were independently associated with incident HF risk. Incident HF among patients with AF was independently associated with higher risk of mortality, all-cause hospitalization, and bleeding events. Conclusions Incident HF among patients with AF is common, is more likely to be HF with preserved ejection fraction, and is associated with poor long-term outcomes. Traditional HF risk factors, AF type, and baseline heart rate are independent clinical predictors of incident HF.
Abstract Background The role of triple antithrombotic therapy vs dual antithrombotic therapy in patients with both atrial fibrillation and coronary artery disease remains unclear. This study explores ...the differences in treatment practices and outcomes between triple antithrombotic therapy and dual antithrombotic therapy in patients with atrial fibrillation and coronary artery disease. Methods Using the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (n = 10,135), we analyzed outcomes in patients with coronary artery disease (n = 1827) according to treatment with triple antithrombotic therapy (defined as concurrent therapy with an oral anticoagulant, a thienopyridine, and aspirin) or dual antithrombotic therapy (comprising either an oral anticoagulant and one antiplatelet agent OAC plus AA or 2 antiplatelet drugs and no anticoagulant DAP). Results The use of triple antithrombotic therapy, OAC plus AA, and DAP at baseline was 8.5% (n = 155), 80.4% (n = 1468), and 11.2% (n = 204), respectively. Among patients treated with OAC plus AA, aspirin was the most common antiplatelet agent used (90%), followed by clopidogrel (10%) and prasugrel (0.1%). The use of triple antithrombotic therapy was not affected by patient risk of either stroke or bleeding. Patients treated with triple antithrombotic therapy at baseline were hospitalized for all causes (including cardiovascular) more often than patients on OAC plus AA (adjusted hazard ratio 1.75; 95% confidence interval, 1.35-2.26; P <.0001) or DAP (hazard ratio 1.82; 95% confidence interval, 1.25-2.65; P = .0018). Rates of major bleeding or a combined cardiovascular outcome were not significantly different by treatment group. Conclusions Choice of antithrombotic therapy in patients with atrial fibrillation and coronary artery disease was not affected by patient stroke or bleeding risks. Triple antithrombotic therapy-treated patients were more likely to be hospitalized for all causes than those on OAC plus AA or on DAP.
Abstract Background Although digoxin has long been used to treat atrial fibrillation (AF) and heart failure (HF), its safety remains controversial. Objectives This study sought to describe digoxin ...use over time in patients with AF who were stratified by the presence or absence of HF, to characterize the predictors of digoxin use and initiation, and to correlate digoxin use with outcomes. Methods Longitudinal patterns of digoxin use and its association with a variety of outcomes were assessed in a prospective outpatient registry conducted at 174 U.S. sites with enrollment from June 2010 to August 2011. Results Among 9,619 patients with AF and serial follow-up every 6 months for up to 3 years, 2,267 (23.6%) received digoxin at study enrollment, 681 (7.1%) were initiated on digoxin during follow-up, and 6,671 (69.4%) were never prescribed digoxin. After adjusting for other medications, heart rate was 72.9 beats/min among digoxin users and 71.5 beats/min among nonusers (p < 0.0001). Prevalent digoxin use at registry enrollment was not associated with subsequent onset of symptoms, hospitalization, or mortality (in patients with HF, adjusted hazard ratio HR for death: 1.04; without HF, HR: 1.22). Incident digoxin use during follow-up was not associated with subsequent death in patients with HF (propensity adjusted HR: 1.05), but was associated with subsequent death in those without HF (propensity adjusted HR: 1.99). Conclusions After adjustment for detailed clinical factors, digoxin use in registry patients with AF had a neutral association with outcomes under most circumstances. Because of the multiple conflicting observational reports about digoxin’s safety and possible concerns in specific clinical situations, a large pragmatic trial of digoxin therapy in AF is needed.
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