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Importance: A composite score for guideline-directed medical therapy (GDMT) for patients with heart failure (HF) is associated with increased survival. Whether hospital performance according to a GDMT score is associated with a broader array of clinical outcomes at lower costs is unknown., Objectives: To evaluate hospital variability in GDMT score at discharge, 90-day risk-standardized clinical outcomes and costs, and associations between hospital GDMT score and clinical outcomes and costs., Design, Setting, and Participants: This was a retrospective cohort study conducted from January 2015 to September 2019. Included for analysis were patients hospitalized for HF with reduced ejection fraction (HFrEF) in the Get With the Guidelines-Heart Failure Registry, a national hospital-based quality improvement registry. Study data were analyzed from July 2022 to April 2023., Exposures: GDMT score at discharge., Main Outcomes and Measures: Hospital variability in GDMT score, a weighted index from 0 to 1 of GDMT prescribed divided by the number of medications eligible, at discharge was evaluated using a generalized linear mixed model using the hospital as a random effect and quantified with the adjusted median odds ratio (AMOR). Parallel analyses centering on 90-day mortality, HF rehospitalization, mortality or HF rehospitalization, home time, and costs were performed. Costs were assessed from the perspective of the Centers of Medicare & Medicaid Services. Associations between hospital GDMT score and clinical outcomes and costs were evaluated using Spearman coefficients., Results: Among 41 161 patients (median [IQR] age, 78 [71-85] years; 25 546 male [62.1%]) across 360 hospitals, there was significant hospital variability in GDMT score at discharge (AMOR, 1.23; 95% CI, 1.21-1.26), clinical outcomes (mortality AMOR, 1.17; 95% CI, 1.14-1.24; HF rehospitalization AMOR, 1.22; 95% CI, 1.18-1.27; mortality or HF rehospitalization AMOR, 1.21; 95% CI, 1.18-1.26; home time AMOR, 1.07; 95% CI, 1.06-1.10) and costs (AMOR, 1.23; 95% CI, 1.21-1.26). Higher hospital GDMT score was associated with lower hospital mortality (Spearman ρ, -0.22; 95% CI, -0.32 to -0.12; P < .001), lower mortality or HF rehospitalization (Spearman ρ, -0.17; 95% CI, -0.26 to -0.06; P = .002), more home time (Spearman ρ, 0.14; 95% CI, 0.03-0.24; P = .01), and lower cost (Spearman ρ, -0.11; 95% CI, -0.21 to 0; P = .047) but not with HF rehospitalization (Spearman ρ, -0.10; 95% CI, -0.20 to 0; P = .06)., Conclusions and Relevance: Results of this cohort study reveal that hospital variability in GDMT score, clinical outcomes, and costs was significant. Higher GDMT score at discharge was associated with lower mortality, lower mortality or hospitalization, more home time, and lower cost. Efforts to increase health care value should include GDMT optimization.

Competing Interests: None.

Background: The use of recommended heart failure (HF) medications has improved over time, but opportunities for improvement persist among women and at rural hospitals., Objectives: This study aims to characterize national trends in performance in the use of guideline-recommended pharmacologic treatment for HF at U.S. Department of Veterans Affairs (VA) hospitals, at which medication copayments are modest., Methods: Among patients discharged from VA hospitals with HF between January 1, 2013, and December 31, 2019, receipt of all guideline-recommended HF pharmacotherapy among eligible patients was assessed, consisting of evidence-based beta-blockers; angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or angiotensin receptor neprilysin inhibitors; mineralocorticoid receptor antagonists; and oral anticoagulation., Results: Of 55,560 patients at 122 hospitals, 32,304 (58.1%) received all guideline-recommended HF medications for which they were eligible. The proportion of patients receiving all recommended medications was higher in 2019 relative to 2013 (OR: 1.54; 95% CI: 1.44-1.65). The median of hospital performance was 59.1% (Q1-Q3: 53.2%-66.2%), improving with substantial variation across sites from 2013 (median 56.4%; Q1-Q3: 50.0%-62.0%) to 2019 (median 65.7%; Q1-Q3: 56.3%-73.5%). Women were less likely to receive recommended therapies than men (adjusted OR [aOR]: 0.84; 95% CI: 0.74-0.96). Compared with non-Hispanic White patients, non-Hispanic Black patients were less likely to receive recommended therapies (aOR: 0.83; 95% CI: 0.79-0.87). Urban hospital location was associated with lower likelihood of medication receipt (aOR: 0.73; 95% CI: 0.59-0.92)., Conclusions: Forty-two percent of patients did not receive all recommended HF medications at discharge, particularly women, minority patients, and those receiving care at urban hospitals. Rates of use increased over time, with variation in performance across hospitals., Competing Interests: Funding Support and Author Disclosures This research was funded by VA Career Development Award HX002621 from the VA Health Services and Research Development Service and Career Development Award 19CDA347670126 from the American Heart Association. Dr Swat was funded by National Institutes of Health T32 training grant 5T32-HL-007822-22. The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Published by Elsevier Inc.)

Aim: The "2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation" provides recommendations to guide clinicians in the treatment of patients with atrial fibrillation., Methods: A comprehensive literature search was conducted from May 12, 2022, to November 3, 2022, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Library, the Agency for Healthcare Research and Quality, and other selected databases relevant to this guideline. Additional relevant studies, published through November 2022, during the guideline writing process, were also considered by the writing committee and added to the evidence tables, where appropriate., Structure: Atrial fibrillation is the most sustained common arrhythmia, and its incidence and prevalence are increasing in the United States and globally. Recommendations from the "2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation" and the "2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing atrial fibrillation and thromboembolic risk assessment, anticoagulation, left atrial appendage occlusion, atrial fibrillation catheter or surgical ablation, and risk factor modification and atrial fibrillation prevention have been developed.

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 off-label 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., Competing Interests: Disclosures None.

Background: Initiation of evidence-based medications for patients with heart failure with reduced ejection fraction (HFrEF) during hospitalization in contemporary practice is unknown., Objectives: This study characterized opportunities for and achievement of heart failure (HF) medication initiation., Methods: Using the GWTG-HF (Get With The Guidelines-Heart Failure) Registry 2017-2020, which collected data on contraindications and prescribing for 7 evidence-based HF-related medications, we assessed the number of medications for which each patient with HFrEF was eligible, use before admission, and prescribed at discharge. Multivariable logistic regression identified factors associated with medication initiation., Results: Among 50,170 patients from 160 sites, patients were eligible for mean number of 3.9 ± 1.1 evidence-based medications with 2.1 ± 1.3 used before admission and 3.0 ± 1.0 prescribed on discharge. The number of patients receiving all indicated medications increased from admission (14.9%) to discharge (32.8%), a mean net gain of 0.9 ± 1.3 medications over a mean of 5.6 ± 5.3 days. In multivariable analysis, factors associated with lower odds of HF medication initiation included older age, female sex, medical pre-existing conditions (stroke, peripheral arterial disease, pulmonary disease, and renal insufficiency), and rural location. Odds of medication initiation increased during the study period (adjusted OR: 1.08; 95% CI: 1.06-1.10)., Conclusions: Nearly 1 in 6 patients received all indicated HF-related medications on admission, increasing to 1 in 3 on discharge with an average of 1 new medication initiation. Opportunities to initiate evidence-based medications persist, particularly among women, those with comorbidities, and those receiving care at rural hospitals., Competing Interests: Funding Support and Author Disclosures Dr Swat has received funding from the National Institutes of Health (NIH) T32 Training Grant 5T32-HL-007822-22. The GWTG-HF (Get With The Guidelines–Heart Failure) program is provided by the American Heart Association. GWTG-HF is sponsored, in part, by Novartis, Boehringer Ingelheim, Novo Nordisk, AstraZeneca, Bayer, Tylenol, and Alnylam Pharmaceuticals. Dr Allen has received grant funding from American Heart Association (AHA), NIH, and Patient-Centered Outcomes Research Institute (PCORI); and has received consulting fees from Abbott, ACI Clinical, Amgen, Boston Scientific, Cytokinetics, and Novartis. Dr Greene has received research support from the Duke University Department of Medicine Chair’s Research Award, American Heart Association, Amgen, AstraZeneca, Bristol Myers Squibb, Cytokinetics, Merck, Novartis, Pfizer, and Sanofi; has served on advisory boards for Amgen, AstraZeneca, Bristol Myers Squibb, Cytokinetics, Roche Diagnostics, and Sanofi; has received speaker fees from Boehringer Ingelheim; and has served as a consultant for Amgen, Bayer, Bristol Myers Squibb, Merck, PharmaIN, Roche Diagnostics, Sanofi, Urovant Pharmaceuticals, and Vifor. Dr DeVore has received research funding through his institution from the American Heart Association, Amgen, Biofourmis, Bodyport, Cytokinetics, American Regent Inc, the National Heart, Lung, and Blood Institute (NHLBI), and Novartis; he has also provided consulting services for and/or received honoraria from Abiomed, Amgen, AstraZeneca, Cardionomic, InnaMed, LivaNova, Natera, Novartis, Procyrion, Story Health, Vifor, and Zoll; he has also received nonfinancial support from Abbott for educational and research activities. Dr Peterson is supported by the NHLBI of the NIH under Award Number R33HL143324. Dr Fonarow has consulted for Abbott, Amgen, AstraZeneca, Bayer, Cytokinetics, Edwards, Janssen, Medtronic, Merck, and Novartis. Dr Hess is supported by VA Career Development Award HX002621 and American Heart Association Career Development Award 19CDA34760126. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Published by Elsevier Inc.)

Background: Left atrial appendage occlusion is an important alternative to anticoagulation in select patients with nonvalvular atrial fibrillation. Trends in real-world device sizing and associated short-term complications have not been characterized., Methods: Using the National Cardiovascular Data Left Atrial Appendage Occlusion (NCDR LAAO) Registry, patients who underwent left atrial appendage occlusion with a Watchman 2.5 device from January 1, 2016, to June 30, 2020, were identified. Patients were stratified by device size based on left atrial appendage orifice size, and categorized as receiving a device that was undersized, oversized, or per manufacturer recommendation. Relationships between device sizing and short-term outcomes, including pericardial effusion, device embolism, and significant leak, were assessed., Results: Of the 68 456 patients, 6539 (10.5%) of patients received undersized devices, 17 791 (26.0%) according to manufacturer recommendations, and 44 126 (64.4%) received an oversized device. The 27-mm device was most commonly deployed [21 736 (31.8%)], whereas the smallest and largest devices (21 and 33 mm) were least commonly deployed [7695 (11.2%) and 9077 (13.3%), respectively]. Compared with manufacturer recommended sizing, there was no difference in the odds of pericardial effusion for either undersized (1.048 [95% CI' 0.801-1.372]; P= 0.733) or oversized (1.101 [95% CI' 0.933-1.298]; P= 0.254) devices. Similarly, relative to manufacturer recommended sizing, the odds of a composite adverse outcome of device migration or embolization and significant peridevice leak at 45 days were similar among undersized devices (1.030 [95% CI' 0.735-1.444]; P= 0.863) and favorable for oversized devices (0.701 [95% CI' 0.561-0.876]; P= 0.002) devices, primarily driven by lower odds of leak. Selection of oversized devices increased significantly over the study period (from 60.3% in 2016 to 66.0% in 2020; P <0.001)., Conclusions: Among patients undergoing left atrial appendage occlusion with the first-generation Watchman device, receipt of oversized devices was common and increased over time. The high prevalence of oversizing was associated with lower odds of significant leak or device embolization without increased odds of other adverse events.

Importance: Up to 60% of patients in the US receive a stress test within 2 years of percutaneous coronary intervention (PCI), prompting concerns about the possible overuse of stress testing., Objective: To examine the proportion of patients who underwent stress testing within 2 years of elective PCI, proportion of patients who had symptoms that were consistent with coronary artery disease (CAD), timing of stress testing, and site-level variation in stress testing among symptomatic and asymptomatic patients., Design, Setting, and Participants: This cohort study used administrative claims data and clinical records from the US Department of Veterans Affairs (VA) Clinical Assessment, Reporting, and Tracking program. Patients who underwent stress testing within 2 years of elective PCI for stable CAD between November 1, 2013, and October 31, 2015, at 64 VA facilities were included in the analysis. Patients who received stress testing for staging purposes, cardiac rehabilitation evaluation, or preoperative testing before high-risk surgery were excluded. Data were analyzed from June to December 2020., Main Outcomes and Measures: The main outcome was the proportion of patients who underwent stress testing and had symptoms that were consistent with obstructive CAD, using definitions from the 2013 clinical practice guideline (Multimodality Appropriate Use Criteria for the Detection and Risk Assessment of Stable Ischemic Heart Disease). Secondary outcomes were the timing of stress testing (assessed using a cumulative incidence curve) and site-level variation in stress testing (assessed using multilevel logistic regression models)., Results: A total of 3705 consecutive patients (mean [SD] age 66.3 [7.6] years; 3656 men [98.7%]; 437 Black individuals [11.8%], 3175 White individuals [85.7%], and 93 individuals [2.5%] of other races and ethnicities [Asian, Hispanic or Latinx, or unknown]) had elective PCI. Of these patients, 916 (24.7%) received a stress test within 2 years, among whom 730 (79.7%) had symptoms that were consistent with obstructive CAD at the time of stress testing. Visual inspection of a cumulative incidence curve for stress testing showed no rapid increases in stress testing at 6 months or 1 year after PCI, which might coincide with routine clinical visits. The proportion of symptomatic patients who underwent stress testing at each VA site ranged from 67.7% to 100%, with no significant site-level variation in stress testing., Conclusions and Relevance: Results of this study suggest that most veterans who underwent stress testing within 2 years after elective PCI had symptoms that were consistent with obstructive CAD. Therefore, measuring low-value stress testing using only administrative claims data may overestimate its prevalence, and concerns about overuse of post-PCI stress testing may be overstated.

Objectives: 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., Background: Insights on contemporary use of same-day discharge following elective PCI are limited., Methods: 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., Results: 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)., Conclusions: 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., Competing Interests: Funding Support and Author Disclosures This study was supported by the American College of Cardiology’s NCDR. The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Representatives of the CathPCI Registry research and publications committee approved the final manuscript. Dr Bradley serves as an associate editor for JAMA Network Open. Dr Hess is supported by VA Career Development Award HX002621 from the U.S. Department of Veterans Affairs Health Services and Research Development Service and Career Development Award 19CDA347670126 from the American Heart Association. Dr Ho is supported by grants from the National Heart, Lung, and Blood Institute, the Department of Veterans Affairs Health Services and Research Development Service, and the University of Colorado School of Medicine; has a research agreement with Bristol Myers Squibb through the University of Colorado; and serves as the deputy editor for Circ Cardiovasc Qual Outcomes. Dr Maddox has received current grant funding from the National Center for Advancing Translational Sciences (grant 1U24TR002306-01: A National Center for Digital Health Informatics Innovation); is a consultant for Creative Educational Concepts and Atheneum Partners; has received honoraria and/or expense reimbursement in the past 3 years from New York Presbyterian (September 2017), Westchester Medical Center (October 2017), Sentara Heart Hospital (December 2018), the Henry Ford health system (March 2019), and the University of California-San Diego (January 2020); is currently employed as a cardiologist and the executive director of the Healthcare Innovation Lab at BJC HealthCare/Washington University School of Medicine, in which capacity he is an adviser to Myia Labs, for which his employer receives equity compensation in the company, but he receives no individual compensation from the company; and is a compensated director for a New Mexico–based foundation, the J.F. Maddox Foundation. Dr Brilakis has received consulting and speaker honoraria from Abbott Vascular, the American Heart Association (associate editor, Circulation), Amgen, Biotronik, Boston Scientific, the Cardiovascular Innovations Foundation (board of directors), CSI, Elsevier, GE Healthcare, InfraRedx, Medtronic, Siemens, and Teleflex; has received research support from Regeneron and Siemens; and is a shareholder in MHI Ventures. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. All rights reserved.)

Comparisons of the outcomes of patients with myocardial infarction with nonobstructive coronary artery disease (MINOCA) and patients with nonobstructive coronary artery disease (CAD) without myocardial infarction (MI) are limited. Here we compare the outcomes of patients with MINOCA and patients with nonobstructive CAD without MI and assess the influence of medical therapy on outcomes in these patients. Veterans who underwent coronary angiography between 2008 to 2017 with nonobstructive CAD were divided into those with or without pre-procedural troponin elevation. Patients with prior revascularization, heart failure, or who presented with cardiogenic shock, STEMI, or unstable angina were excluded. After propensity matching, outcomes were compared between groups. The primary outcome was major adverse cardiovascular events (MACE: mortality, myocardial infarction, and revascularization) within one year: 3,924 patients with nonobstructive CAD and a troponin obtained prior to angiography were identified (n=1,986 with elevated troponin) and restricted to 1,904 patients after propensity-matching. There was a significantly higher risk of MACE among troponin-positive patients compared with those with a negative troponin (HR 2.37; 95% CI, 1.67 to 3.34). Statin (HR 0.32; 95% CI, 0.22 to 0.49) and ACE inhibitor (HR 0.49; 95% CI, 0.32 to 0.75) therapy after angiography was associated with decreased MACE, while P2Y12 inhibitor, calcium-channel and beta-blocker therapy were not associated with outcomes. In conclusion, Veterans with MINOCA are at increased risk for MACE compared with those with nonobstructive CAD and negative troponin at the time of angiography. Specific medications were associated with a reduction in MACE, suggesting an opportunity to explore novel approaches for secondary prevention in this population., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Aim: To assess the unrealized potential of glucagon-like peptide-1 receptor agonist (GLP-1RA) or sodium-glucose co-transport-2 inhibitor (SGLT2i) use to reduce mortality in veterans with type 2 diabetes (T2D), coronary artery disease (CAD), and other characteristics congruent with clinical trial cohorts that established the efficacy of these agents., Methods: Veterans with T2D and CAD on angiography in 2014 who were untreated with either a GLP-1RA or a SGLT2i were assessed for key eligibility criteria of the LEADER (GLP-1RA) and EMPA-REG OUTCOME (SGLT2i) trials. Trial hazard ratios and 95% confidence intervals for all-cause death were applied to deaths observed in veterans through 2018 to estimate the potential benefit of GLP-1RA or SGLT2i use., Results: Median observation was 4.3 years. Of 15 987 veterans with T2D and CAD, 1186 (7.4%) were excluded for GLP-1RA or SGLT2i treatment, and 1386 lacked glycated haemoglobin measurement. Of the remaining 13 415 patients, 4103 (30.1%) and 5313 (39.6%) fulfilled the key criteria for the LEADER and EMPA-REG OUTCOME trials, respectively. Death occurred in 1009 (24.6%) of LEADER-eligible patients and 1335 (25.1%) of EMPA-REG OUTCOME-eligible patients. Under treatment with liraglutide in LEADER-eligible veterans, a 3.5% (0.7%-6.2%) potential absolute mortality reduction, corresponding to 144 (28-253) fewer deaths (0.88 [0.17-1.56] per 100 person-years), might have been expected. Similarly, under treatment with empagliflozin in EMPA-REG OUTCOME-eligible veterans, a 7.9% (4.5%-10.8%) potential absolute mortality reduction, corresponding to 418 (230-573) fewer deaths (1.98 [1.14-2.72] per 100 person-years), might have been expected., Conclusions: This analysis indicates unrealized opportunities to reduce mortality in selected veterans with T2D and CAD via increased GLP-1RA and SGLT2i use., (Published 2020. This article is a U.S. Government work and is in the public domain in the USA.)

Background: Prevalence and prognostic value of diastolic and systolic dyssynchrony in patients with coronary artery disease (CAD) + heart failure (HF) or CAD alone are not well understood., Methods: We included patients with gated single-photon emission computed tomography (GSPECT) myocardial perfusion imaging (MPI) between 2003 and 2009. Patients had at least one major epicardial obstruction ≥ 50%. We assessed the association between dyssynchrony and outcomes, including all-cause and cardiovascular death., Results: Of the 1294 patients, HF was present in 25%. Median follow-up was 6.7 years (IQR 4.9-9.3) years with 537 recorded deaths. Patients with CAD + HF had a higher incidence of dyssynchrony than patients with CAD alone (diastolic BW 28.8% for the HF + CAD vs 14.7% for the CAD alone). Patients with CAD + HF had a lower survival than CAD alone at 10 years (33%; 95% CI 27-40 vs 59; 95% CI 55-62, P < 0.0001). With one exception, HF was found to have no statistically significant interaction with dyssynchrony measures in unadjusted and adjusted survival models., Conclusions: Patients with CAD + HF have a high prevalence of mechanical dyssynchrony as measured by GSPECT MPI, and a higher mortality than CAD alone. However, clinical outcomes associated with mechanical dyssynchrony did not differ in patients with and without HF.

Importance: In hospitals outside of the US Department of Veterans Affairs (VA) system, 1 in 10 percutaneous coronary interventions (PCIs) for stable coronary artery disease is considered rarely appropriate by the appropriate use criteria, with variation across hospitals. The appropriateness of PCIs in VA hospitals has not been documented., Objective: To characterize the appropriateness of PCIs in VA hospitals., Design, Setting, and Participants: This retrospective cohort study included patients with stable coronary artery disease undergoing elective PCI from November 1, 2013, to October 31, 2015, within the VA Clinical Assessment, Reporting, and Tracking Program, an operational program that includes 59 VA hospitals. Data were analyzed from March 1, 2019, to August 8, 2019., Exposures: Elective PCI at a VA hospital., Main Outcomes and Measures: Proportion of PCIs classified as appropriate, may be appropriate, or rarely appropriate; extent of hospital-level variation in rarely appropriate PCIs using criteria issued by cardiovascular professional societies in 2012. The extent of hospital-level variation in rates of rarely appropriate PCI was characterized using hospital proportions and random-effect logistic regression., Results: Among 2611 patients undergoing elective PCI (mean [SD] age, 66.3 [7.6] years; 2577 [98.7%] men) at 59 hospitals, a total of 778 PCIs (29.8%) were classified as appropriate, 1561 PCIs (59.8%) were classified as may be appropriate, and 272 PCIs (10.4%) were classified as rarely appropriate. Rarely appropriate PCIs were more commonly performed in patients who had low-risk stress test findings (220 patients [89.1%]), who were taking no (100 patients [36.8%]) or 1 (167 patients [61.4%]) antianginal medication, or who had 1 coronary artery stenosis (185 patients [68.0%]). The unadjusted hospital-level rates of rarely appropriate PCIs ranged from 0% to 28.6%, with a median (interquartile range) of 9.7% (6.3%-13.9%). Random-effect models yielded an estimated median (interquartile range) rate of rarely appropriate PCI of 10.4% (8.7%-12.3%)., Conclusions and Relevance: These findings suggest that in VA practice, most PCIs for stable coronary artery disease were classified as appropriate or may be appropriate. However, 1 in 10 PCIs was classified as rarely appropriate, with variation across VA hospitals. Efforts to improve patient selection are needed.

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., (Copyright © 2019. Published by Elsevier Inc.)

Most implantable cardioverter defibrillators (ICDs) are implanted for the purpose of primary prevention of sudden cardiac death among older patients with heart failure with reduced ejection fraction. Shared decision-making prior to device implantation is guideline-recommended and payer-mandated. This article summarizes patient and provider attitudes toward device placement, device efficacy and effectiveness, potential periprocedural complications, long-term events such as shocks, quality of life, costs, and shared decision-making principles and recommendations. Most patients eligible for an ICD anticipate more than 10 years of survival. Physicians are less likely to offer an ICD to patients ≥80 years of age given a perceived lack of benefit. There is a dearth of data from randomized clinical trials addressing device efficacy among older patients; there is a need for more research in this area. However, currently available data support the use of ICDs irrespective of age provided life expectancy exceeds 1 year. Advanced age is independently associated with complications at the time of device placement but not the risk of device infection. The risk of inappropriate shock may be comparable or lower than that of younger patients. While quality of life is generally not adversely impacted by an ICD, a subset of patients experience post-traumatic stress disorder. ICDs are cost-effective from societal and health care sector perspectives; however, out-of-pocket costs vary according to insurance type and level. Shared decision-making encounters may be incremental and iterative in nature. Providers are encouraged to partner with their patients, providing them counsel tailored to their values, preferences, and clinical presentation inclusive of age., (© 2019 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.)

Background: Available data suggest that same-day discharge (SDD) after elective percutaneous coronary intervention (PCI) is safe in select patients. Yet, little is known about contemporary adoption rates, safety, and costs in a universal health care system like the Veterans Affairs Health System., Methods: Using data from the Veterans Affairs Clinical Assessment Reporting and Tracking Program linked with Health Economics Resource Center data, patients undergoing elective PCI for stable angina between October 1, 2007 and Sepetember 30, 2016, were stratified by SDD versus overnight stay. We examined trends of SDD, and using 2:1 propensity matching, we assessed 30-day rates of readmission, mortality, and total costs at 30 days., Results: Of 21,261 PCIs from 67 sites, 728 were SDDs (3.9% of overall cohort). The rate of SDD increased from 1.6% in 2008 to 9.7% in 2016 (P < .001). SDD patients had lower rates of atrial fibrillation, peripheral arterial disease, and prior coronary artery bypass grafting and were treated at higher-volume centers. Thirty-day readmission and mortality did not differ significantly between the groups (readmission: 6.7% SDD vs 5.6% for overnight stay, P = .24; mortality: 0% vs. 0.07%, P = .99). The mean (SD) 30-day cost accrued by patients undergoing SDD was $23,656 ($15,480) versus $25,878 ($17,480) for an overnight stay. The accumulated median cost savings for SDD was $1503 (95% CI $738-$2,250)., Conclusions: Veterans Affairs Health System has increasingly adopted SDD for elective PCI procedures, and this is associated with cost savings without an increase in readmission or mortality. Greater adoption has the potential to reduce costs without increasing adverse outcomes., (Copyright © 2019 Elsevier Inc. All rights reserved.)

There is consensus in dissemination and implementation (D&I) science that addressing contextual factors is critically important for understanding translation of health care delivery interventions but little agreement on which contextual factors are key determinants of implementation outcomes. We describe the application of the Practical Robust Implementation and Sustainability Model (PRISM), which expands the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to identify contextual factors across four diverse programs. Multiple qualitative methods were used to collect multilevel, multistakeholder perspectives from the adopting organizations and staff. We identified measures for evaluating context through the various domains of PRISM to guide health services research across the phases of program implementation. The PRISM domains of Recipients, Implementation and Sustainability Infrastructure, and External Environment identified important multilevel contextual factors, including variability in operational processes and available resources. These domains helped to facilitate planning and implementation phases of the four interventions and guide purposeful adaptations. We found assessments of PRISM domains useful to systematically assess multilevel contextual factors across various content areas as well as phases of program implementation. Additionally, these contextual factors were found to be relevant to RE-AIM outcomes. Lessons learned can be applied to future research as there is a need to investigate the measurement properties of PRISM and continue to test which contextual factors are most important to successful implementation and for which outcomes., (Published by Oxford University Press on behalf of the Society of Behavioral Medicine 2019.)

Objectives: The goal of this study was to examine whether diastolic dyssynchrony, measured by using gated single-photon emission computed tomography (GSPECT) myocardial perfusion imaging (MPI) in patients with coronary artery disease (CAD), is independently associated with adverse outcomes., Background: Systolic left ventricular dyssynchrony is known to be associated with worse clinical outcome in patients with CAD., Methods: This study included patients who presented to Duke University for GSPECT MPI between 2003 and 2009. Patients had at least 1 major epicardial obstruction ≥50%. Dyssynchrony was assessed by using Emory Cardiac Toolbox software and compared with a control population without CAD. Abnormal degree of diastolic/systolic dyssynchrony was defined as values above 2 SDs above mean of mechanical dyssynchrony parameters. Using Cox proportional hazards modeling, the adjusted association between dyssynchrony and outcomes, including all-cause and cardiovascular death, was assessed., Results: Among 1,310 patients with a median age of 64 years (interquartile range: 55 to 72 years), 69.7% were male and 2.6% had left bundle branch block. Overall, 241 (18.4%) and 238 (18.2%) patients had significant systolic and diastolic mechanical dyssynchrony, respectively, and 211 (16.1%) had both. After a median follow-up of 7.1 years, 543 deaths occurred. At 5 years, the mortality estimate was 21.2% among patients with a normal degree of diastolic left ventricular mechanical dyssynchrony (LVMD) and 41.7% among those with an abnormal degree of LVMD (p < 0.001). When added to clinical comorbidities, electrical dyssynchrony, and systolic LVMD, diastolic dyssynchrony was incrementally associated with cardiovascular mortality (global chi-square statistic of 211.9 vs. 222.8; 2 degrees of freedom; p = 0.004). In a model that also includes left ventricular ejection fraction, the addition of diastolic dyssynchrony to systolic dyssynchrony maintained an incremental prognostic benefit (global chi-square statistic of 234.8 vs. 241.8; p = 0.030). Adjustment for baseline ischemia and scar burden did not change this relationship., Conclusions: Systolic and diastolic left ventricular dyssynchrony, as measured by using GSPECT MPI, were associated with adverse outcomes. Moreover, diastolic dyssynchrony appears to provide incremental predictive value to clinical history, electrical dyssynchrony, and left ventricular function., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Many health outcomes and implementation science studies have demonstrated the importance of tailoring evidence-based care interventions to local context to improve fit. By adapting to local culture, history, resources, characteristics, and priorities, interventions are more likely to lead to improved outcomes. However, it is unclear how best to adapt evidence-based programs and promising innovations. There are few guides or examples of how to best categorize or assess health-care adaptations, and even fewer that are brief and practical for use by non-researchers., Materials and Methods: This study describes the importance and potential of assessing adaptations before, during, and after the implementation of health systems interventions. We present a promising multilevel and multimethod approach developed and being applied across four different health systems interventions. Finally, we discuss implications and opportunities for future research., Results: The four case studies are diverse in the conditions addressed, interventions, and implementation strategies. They include two nurse coordinator-based transition of care interventions, a data and training-driven multimodal pain management project, and a cardiovascular patient-reported outcomes project, all of which are using audit and feedback. We used the same modified adaptation framework to document changes made to the interventions and implementation strategies. To create the modified framework, we started with the adaptation and modification model developed by Stirman and colleagues and expanded it by adding concepts from the RE-AIM framework. Our assessments address the intuitive domains of Who, How, When, What, and Why to classify and organize adaptations. For each case study, we discuss how the modified framework was operationalized, the multiple methods used to collect data, results to date and approaches utilized for data analysis. These methods include a real-time tracking system and structured interviews at key times during the intervention. We provide descriptive data on the types and categories of adaptations made and discuss lessons learned., Conclusion: The multimethod approaches demonstrate utility across diverse health systems interventions. The modified adaptations model adequately captures adaptations across the various projects and content areas. We recommend systematic documentation of adaptations in future clinical and public health research and have made our assessment materials publicly available.

Background: Scientific statements have championed the measurement of clinical outcomes after cardiac stress testing to better define their value. Using contemporary national data, we sought to describe the characteristics of patients who experience outcomes after stress testing., Methods and Results: Using administrative claims from a large national private insurer, we conducted an observational cohort study of patients without cardiovascular disease aged 25 to 64 years who underwent stress testing from 2006 to 2011 and had at least 1 year of membership in the insurance company before and after testing. We used Kaplan-Meier time-to-event analyses to determine rates of acute myocardial infarction (AMI), elective coronary revascularization, and coronary angiography without revascularization in the year following testing. We used logistic regression to determine factors associated with outcomes, and stratified the cohort into quintiles based on likelihood of experiencing AMI and/or revascularization to describe the characteristics of patients at highest and lowest risk. Among 553 027 patients who underwent stress testing (mean age 50 years, 49% women, 73% white), 0.8% were hospitalized for AMI, 1.8% underwent elective coronary revascularization, and 2.5% underwent coronary angiography without revascularization within 1 year. Patients who were older, male, and white were more likely to undergo subsequent revascularization. Patients in the lowest likelihood quintile were young (mean age 40 years), frequently women (84.7%), had a low incidence of coexisting conditions (5.2% with diabetes mellitus), and had a 0.5% rate of AMI and/or revascularization., Conclusions: The proportion of US patients younger than 65 who had AMI and/or coronary revascularization after stress testing was low. Assessing risk of subsequent outcomes may be useful in improving patient referrals for stress testing., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Background: The direct oral anticoagulants (DOACs) reduce the risk of stroke in moderate to high-risk patients with non-valvular atrial fibrillation (AF). Yet, concerns remain regarding its routine use in real world practice. We sought to describe adherence patterns and the association between adherence and outcomes to the DOACs among outpatients with AF., Methods: We performed a retrospective cohort study of patients in the VA Healthcare System who initiated pharmacotherapy with dabigatran, rivaroxaban, or apixaban between November 2010 and January 2015 for non-valvular AF with CHA 2 DS 2 -VASc score ≥ 2. Adherence was determined using pharmacy refill data and estimated by the proportion of days covered (PDC) over the first year of therapy. Clinical outcomes, including all-cause mortality and stroke, were measured at 6 months and used to assess measures of adherence for each DOAC., Results: A total of 2882 patients were included. Most were prescribed dabigatran (72.7%), compared with rivaroxaban (19.8%) or apixaban (7.5%). The mean PDC was 0.84 ± 0.20 for dabigatran, 0.86 ± 0.18 for rivaroxaban, and 0.89 ± 0.14 for apixaban (p < 0.01). The proportion of non-adherent patients, PDC <0.80, was 27.6% for all and varied according DOAC. Lower adherence to dabigatran was associated with higher risk of mortality and stroke (HR 1.07; 1.03-1.12 per 0.10 decline in PDC)., Conclusions: In a real-world VA population being prescribed anticoagulation for AF, more than one quarter had sub-optimal adherence. Lower adherence was associated with a higher risk of mortality and stroke. Efforts identifying non-adherent patients, and targeted adherence interventions are needed to improve outcomes.

Background: Prior studies have demonstrated a link between the metabolic syndrome and increased risk of cardiovascular mortality. Whether the metabolic syndrome is associated with sudden cardiac death is uncertain., Methods and Results: We characterized the relationship between sudden cardiac death and metabolic syndrome status among participants of the ARIC (Atherosclerosis Risk in Communities) Study (1987-2012) free of prevalent coronary heart disease or heart failure. Among 13 168 participants, 357 (2.7%) sudden cardiac deaths occurred during a median follow-up of 23.6 years. Participants with the metabolic syndrome (n=4444) had a higher cumulative incidence of sudden cardiac death than those without it (n=8724) (4.1% versus 2.3%, P <0.001). After adjustment for participant demographics and clinical factors other than components of the metabolic syndrome, the metabolic syndrome was independently associated with sudden cardiac death (hazard ratio, 1.70, 95% confidence interval, 1.37-2.12, P <0.001). This relationship was not modified by sex (interaction P =0.10) or race (interaction P =0.62) and was mediated by the metabolic syndrome criteria components. The risk of sudden cardiac death varied according to the number of metabolic syndrome components (hazard ratio 1.31 per additional component of the metabolic syndrome, 95% confidence interval, 1.19-1.44, P <0.001). Of the 5 components, elevated blood pressure, impaired fasting glucose, and low high-density lipoprotein were independently associated with sudden cardiac death., Conclusions: We observed that the metabolic syndrome was associated with a significantly increased risk of sudden cardiac death irrespective of sex or race. The risk of sudden cardiac death was proportional to the number of metabolic syndrome components., (© 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Background: The prognostic value of left ventricular dyssynchrony measured by gated single-photon emission computed tomography (GSPECT) myocardial perfusion imaging (MPI) and its relationship to electrical dyssynchrony measured by QRS duration are incompletely understood. The aim of this study was therefore to examine the independent and incremental prognostic value of dyssynchrony in yet the largest group of patients with coronary artery disease (CAD)., Methods and Results: Patients presenting for GSPECT- MPI between July 1993 and May 1999 in normal sinus rhythm were identified from the Duke Nuclear Cardiology Databank and the Duke Databank for Cardiovascular Disease (N = 1244). After a median of 4.2 years, 336 deaths occurred. At 8 years, the Kaplan-Meier estimates of the probability of death were 34.0% among patients with a phase bandwidth <100° and 56.8% among those with a bandwidth ≥100°. After adjustment for standard clinical variables, QRS dyssynchrony was independently associated with death (Hazard Ratio (HR), per 10°: 1.092, 95% Confidence Interval (CI) 1.048,1.139, P < .0001). Phase bandwidth was similarly associated with death after clinical adjustment (HR per 10°: 1.056, 95% CI 1.041,1.072, P < .0001). In clinically adjusted models examining QRS duration in addition to phase bandwidth, phase bandwidth had a stronger association with mortality. After accounting for left ventricular ejection fraction (LVEF), neither QRS duration nor phase bandwidth were statistically significant. Among patients with EF >35%, QRS duration and phase bandwidth together provided value above that provided by LVEF alone (P = 0.0181). When examining cardiovascular death, results were consistent with all-cause death., Conclusions: Among patients with CAD, mechanical left ventricular dyssynchrony measured by GSPECT MPI has a stronger relationship with outcomes than electrical dyssynchrony measured by QRS duration. After adjustment for baseline characteristics and LVEF, neither mechanical nor electrical dyssynchrony is independently associated with all-cause death or cardiac death. Among patients with EF >35%, mechanical and electrical dyssynchrony together provided prognostic value above that afforded by LVEF.

Background: Prior studies have shown a treatment gap in oral anticoagulation (OAC) use among patients with atrial fibrillation yet have incompletely characterized factors associated with failure to treat and subsequent outcomes in contemporary practice., Methods: Using data collected between June 2010 and August 2011 from 174 ambulatory care sites in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation, we identified factors associated with absence of OAC via stratified logistic regression. Using weighted Cox regression, we assessed the association between OAC non-use and subsequent outcomes over 2.5 years., Results: Among 9553 patients, 2202 (23.0%) were not on OAC. Among OAC nonrecipients, 1846 (83.8%) had a CHA 2 DS 2 -VASc score ≥2. Factors independently associated with OAC non-use included atrial fibrillation type (paroxysmal odds ratio [OR] 0.73, 95% confidence interval [CI] 0.54-0.99; persistent OR 0.14, 95% CI 0.10-0.21; permanent OR 0.35, 95% CI 0.25-0.49; reference = new-onset), left atrial diameter enlargement (mild OR 0.80, 95% CI 0.66-0.97; moderate 0.58, 95% CI 0.47-0.73; severe 0.53, 95% CI 0.42-0.68; reference = normal diameter), and age >80 years (OR 1.04, 95% CI 1.02-1.08). Untreated patients had a higher risk of death (adjusted hazard ratio [HR] 1.22, 95% CI 1.05-1.41), a lower bleeding risk (adjusted HR 0.35, 95% CI 0.15-0.81), and a nonsignificant trend toward higher risk of stroke/non-central nervous system embolism/transient ischemic attack than those treated (adjusted HR 1.18, 95% CI 0.91-1.54)., Conclusions: A majority of atrial fibrillation patients not treated with an OAC in current community practice meet guideline indications for treatment. Atrial fibrillation burden, chronicity, and comorbidity are associated with nontreatment. Untreated patients are at increased risk for adverse outcomes., (Published by Elsevier Inc.)

Importance: Subclinical atrial fibrillation (AF) is associated with an increased risk for stroke., Observations: Subclinical AF is asymptomatic, short in duration, and usually detected with long-term, continuous monitoring. Most prior studies have explored its consequences using cardiovascular implantable electronic devices (CIEDs). Although current prevalence estimates are derived from study populations with prior CIEDs, 3 trials will assess the time to a first AF diagnosis among patients receiving a CIED for purposes of AF detection. Stroke risk estimates are currently limited to patients with a prior CIED and vary widely, ranging from a hazard ratio of 0.87 (95% CI, 0.58-1.31) to 9.40 (95% CI, 1.80-47.00). Stroke risk pathogenesis may include factors that are proximately causal, upstream risk activators, and risk markers. The treatment of subclinical AF may be a useful stroke prevention strategy; however, no direct evidence of benefit from oral anticoagulation exists in this population. Two ongoing trials will assess the risk and benefit of non-vitamin K oral anticoagulants among patients at high risk for stroke with a previously placed implantable CIED, but without a prior diagnosis of clinical AF. If clinical benefit is proven, then the cost-effectiveness of screening for and the treatment of subclinical AF will require additional study., Conclusions and Relevance: At present, no evidence suggests that implanting a CIED to detect AF or initiating oral anticoagulation therapy among those in whom AF is detected is beneficial. Ongoing and future studies will identify people at high risk for developing subclinical AF and will evaluate the efficacy, safety, and economic value of oral anticoagulation therapy in this population.

Background: Previous studies have found that women and black patients eligible for a primary prevention implantable cardioverter-defibrillator (ICD) are less likely than men or white patients to receive one., Methods: We performed an observational analysis of the Get With The Guidelines-Heart Failure Program from January 1, 2011, to March 21, 2014. Patients admitted with heart failure and an ejection fraction ≤35% without an ICD were included. Rates of ICD counseling among eligible patients and ICD receipt among counseled patients were examined by sex and race/ethnicity., Results: Among 21 059 patients from 236 sites, 4755 (22.6%) received predischarge ICD counseling. Women were counseled less frequently than men (19.3% versus 24.6%, P<0.001, adjusted odds ratio [OR], 0.84; 95% confidence interval [CI], 0.78-0.91). Racial and ethnic minorities were less likely to receive counseling than white patients (black 22.6%, Hispanic 18.6%, other race/ethnic group 14.4% versus white 24.3%, P<0.001 for each): adjusted OR versus white, 0.69; 95% CI, 0.63 to 0.76 for black patients; adjusted OR, 0.62; 95% CI, 0.55 to 0.70 for Hispanic patients; adjusted OR, 0.53; 95% CI, 0.43 to 0.65 for other patients. Among the 4755 counseled patients, 2977 (62.6%) received an ICD or had one planned for placement after hospital stay. Among those counseled, women and men were similarly likely to receive an ICD (adjusted OR, 1.13; 95% CI, 0.99-1.29). However, black (adjusted OR, 0.70; 95% CI, 0.56-0.88) and Hispanic patients (adjusted OR, 0.68; 95% CI, 0.46-1.01) were less likely to receive an ICD., Conclusions: Up to 4 of 5 hospitalized patients with heart failure eligible for ICD counseling did not receive it, particularly women and minority patients. Among counseled patients, ICD use differences by race and ethnicity persisted., (© 2016 American Heart Association, Inc.)

Importance: In the current therapeutic era, the risk for sudden cardiac death (SCD) after non-ST-segment elevation acute coronary syndrome (NSTE ACS) has not been characterized completely., Objective: To determine the cumulative incidence of SCD during long-term follow-up after NSTE ACS, to develop a risk model and risk score for SCD after NSTE ACS, and to assess the association between recurrent events after the initial ACS presentation and the risk for SCD., Design, Setting, and Participants: This pooled cohort analysis merged individual data from 48 286 participants in 4 trials: the Apixaban for Prevention of Acute Ischemic Events 2 (APPRAISE-2), Study of Platelet Inhibition and Patient Outcomes (PLATO), Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER), and Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes (TRILOGY ACS) trials. The cumulative incidence of SCD and cardiovascular death was examined according to time after NSTE ACS. Using competing risk and Cox proportional hazards models, clinical factors at baseline and after the index event that were associated with SCD after NSTE ACS were identified. Baseline factors were used to develop a risk model. Data were analyzed from January 2, 2014, to December 11, 2015., Main Outcomes and Measures: Sudden cardiac death., Results: Of the initial 48 286 patients, 37 555 patients were enrolled after NSTE ACS (67.4% men; 32.6% women; median [interquartile range] age, 65 [57-72] years). Among these, 2109 deaths occurred after a median follow-up of 12.1 months. Of 1640 cardiovascular deaths, 513 (31.3%) were SCD. At 6, 18, and 30 months, the cumulative incidence estimates of SCD were 0.79%, 1.65%, and 2.37%, respectively. Reduced left ventricular ejection fraction, older age, diabetes mellitus, lower estimated glomerular filtration rate, higher heart rate, prior myocardial infarction, peripheral artery disease, Asian race, male sex, and high Killip class were significantly associated with SCD. A model developed to calculate the risk for SCD in trials with systematic collection of left ventricular ejection fraction had a C index of 0.77. An integer-based score was developed from this model and yielded a calculated SCD probability ranging from 0.1% to 56.7% (C statistic, 0.75). In a multivariable model that included time-dependent clinical events occurring after the index hospitalization for ACS, SCD was associated with recurrent myocardial infarction (hazard ratio [HR], 2.95; 95% CI, 2.29-3.80; P < .001) and any hospitalization (HR, 2.45; 95% CI, 1.98-3.03; P < .001), whereas coronary revascularization had a negative relationship with SCD (HR, 0.75; 95% CI, 0.58-0.98; P = .03)., Conclusions and Relevance: In the current therapeutic era, SCD accounts for about one-third of cardiovascular deaths after NSTE ACS. Risk stratification can be performed with good accuracy using commonly collected clinical variables. Clinical events occurring after the index hospitalization are underappreciated but important risk factors.

Objective: Many patients undergoing transcatheter aortic valve implantation (TAVI) have a pre-existing, permanent pacemaker (PPM) or receive one as a consequence of the procedure. We hypothesised that chronic pacing may have adverse effects on TAVI outcomes., Methods and Results: Four groups of patients undergoing TAVI in the Placement of Aortic Transcatheter Valves (PARTNER) trial and registries were compared: prior PPM (n=586), new PPM (n=173), no PPM (n=1612), and left bundle branch block (LBBB)/no PPM (n=160). At 1 year, prior PPM, new PPM and LBBB/no PPM had higher all-cause mortality than no PPM (27.4%, 26.3%, 27.7% and 20.0%, p<0.05), and prior PPM or new PPM had higher rehospitalisation or mortality/rehospitalisation (p<0.04). By Cox regression analysis, new PPM (HR 1.38, 1.00 to 1.89, p=0.05) and prior PPM (HR 1.31, 1.08 to 1.60, p=0.006) were independently associated with 1-year mortality. Surviving prior PPM, new PPM and LBBB/no PPM patients had lower LVEF at 1 year relative to no PPM (50.5%, 55.4%, 48.9% and 57.6%, p<0.01). Prior PPM had worsened recovery of LVEF after TAVI (Δ=10.0 prior vs 19.7% no PPM for baseline LVEF <35%, p<0.0001; Δ=4.1 prior vs 7.4% no PPM for baseline LVEF 35-50%, p=0.006). Paced ECGs displayed a high prevalence of RV pacing (>88%)., Conclusions: In the PARTNER trial, prior PPM, along with new PPM and chronic LBBB patients, had worsened clinical and echocardiographic outcomes relative to no PPM patients, and the presence of a PPM was independently associated with 1-year mortality. Ventricular dyssynchrony due to chronic RV pacing may be mechanistically responsible for these findings., Trial Registration Number: (ClinicalTrials.gov NCT00530894)., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: The impact of patient age on the risks of death or rehospitalization after primary prevention implantable cardioverter-defibrillator (ICD) placement is uncertain., Methods and Results: Data from 5 major ICD trials were merged: the Multicenter Automatic Defibrillator Implantation Trial I (MADIT-I), the Multicenter UnSustained Tachycardia Trial (MUSTT), the Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II), the Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation Trial (DEFINITE), and the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). Median age at enrollment was 62 (interquartile range 53-70) years. Compared with their younger counterparts, older patients had a greater burden of comorbid illness. In unadjusted exploratory analyses, ICD recipients were less likely to die than nonrecipients in all age groups: among patients aged <55 years: hazard ratio 0.48, 95% posterior credible interval 0.33 to 0.69; among patients aged 55 to 64 years: hazard ratio 0.69, 95% posterior credible interval 0.53 to 0.90; among patients aged 65 to 74 years: hazard ratio 0.67, 95% posterior credible interval, 0.53 to 0.85; and among patients aged ≥75 years: hazard ratio 0.54, 95% posterior credible interval 0.37 to 0.78. Sample sizes were limited among patients aged ≥75 years. In adjusted Bayesian-Weibull modeling, point estimates indicate ICD efficacy persists but is attenuated with increasing age. There was evidence of an interaction between age and ICD treatment on survival (two-sided posterior tail probability of no interaction <0.01). Using an adjusted Bayesian logistic regression model, there was no evidence of an interaction between age and ICD treatment on rehospitalization (two-sided posterior tail probability of no interaction 0.44)., Conclusions: In this analysis, the survival benefit of the ICD exists but is attenuated with increasing age. The latter finding may be because of the higher burden of comorbid illness, competing causes of death, or limited sample size of older patients. There was no evidence that age modifies the association between ICD treatment and rehospitalization., (© 2015 American Heart Association, Inc.)

Introduction: We conducted this pilot randomized clinical trial to determine the feasibility of a large clinical trial aimed at testing whether early use of catheter ablation of ventricular tachycardia (VT) is superior to antiarrhythmic medications at reducing mortality., Methods and Results: Patients were enrolled at 4 sites if they had ischemic heart disease, an implantable cardioverter defibrillator (ICD), and received ≥1 ICD shock or ≥3 antitachycardia pacing therapies for VT. Patients were randomized to 2 arms: (1) antiarrhythmic medication (n = 14) and (2) catheter ablation (n = 13); patients were followed at 3 and 6 months. Endpoints included recurrent VT, time to first ICD therapy for VT, and death. Of 243 screened patients, 27 were enrolled. Main reasons for screen failures were: (1) patient was already on an antiarrhythmic medication (88 [41%]), (2) VT due to a reversible cause (23 [11%]), and (3) incessant VT (20 [9%]). Fourteen patients had recurrent VT, 8 (62%) in the ablation arm and 6 (43%) in the antiarrhythmic medication arm. Median time to recurrent VT was 75 days (25th, 75th: 51, 89) in the ablation arm and 57 days (30, 145) in the antiarrhythmic arm. Four patients died, 2 in each arm., Conclusion: This clinical trial shows that most patients in clinical practice have already failed antiarrhythmic drug therapy before catheter ablation is considered, and the VT recurrence rates and death in these patients are high. For a large clinical trial to be feasible, factors limiting early consideration of catheter ablation need to be identified and addressed., (© 2014 Wiley Periodicals, Inc.)

Background: Guidelines recommend that implantable cardioverter-defibrillator (ICD) candidates have an estimated longevity of ≥1 year. Longevity can be affected by chronic kidney disease (CKD)., Methods and Results: Using the National Cardiovascular Data Registry ICD registry linked with the Social Security Death Master File, we assessed the rate of death after primary prevention ICD placement between January 1, 2006, and December 31, 2007, according to CKD stage. Using Cox models, we identified factors associated with death among patients with CKD. Compared with patients without CKD (n=26,056), those with CKD (n=21,226) were older, less commonly men, more often white, and more frequently had comorbid illness. Compared with patients without CKD, patients with a glomerular filtration rate 30 to 60, glomerular filtration rate <30, and end-stage renal disease on dialysis had a higher risk of death after ICD placement (hazard ratio, 2.08; 95% confidence interval, 1.99-2.18; P<0.0001; hazard ratio, 4.20; 95% confidence interval, 3.92-4.50; P<0.0001; and hazard ratio, 4.80; 95% confidence interval, 4.46-5.17; P<0.0001, respectively). Corresponding 1-year death rates were 4.4%, 9.1%, 20.2%, and 22.4%. Among patients with CKD, factors associated with increased risk of death included CKD severity, age >65 years, heart failure symptoms, diabetes mellitus, lung disease, serum sodium <140 mEq/L, atrial fibrillation or flutter, and a lower ejection fraction., Conclusions: The risk of death after primary prevention ICD placement is proportional to CKD severity. Among patients with CKD, several factors are prognostically significant and could inform clinical decision making on primary prevention ICD candidacy., (© 2014 American Heart Association, Inc.)

Background: The benefit of a primary prevention implantable cardioverter-defibrillator (ICD) among patients with chronic kidney disease is uncertain., Study Design: Meta-analysis of patient-level data from randomized controlled trials., Setting & Population: Patients with symptomatic heart failure and left ventricular ejection fraction<35%., Selection Criteria for Studies: From 7 available randomized controlled studies with patient-level data, we selected studies with available data for important covariates. Studies without patient-level data for baseline estimated glomerular filtration rate (eGFR) were excluded., Intervention: Primary prevention ICD versus usual care effect modification by eGFR., Outcomes: Mortality, rehospitalizations, and effect modification by eGFR., Results: We included data from the Multicenter Automatic Defibrillator Implantation Trial I (MADIT-I), MADIT-II, and the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). 2,867 patients were included; 36.3% had eGFR<60 mL/min/1.73m2. Kaplan-Meier estimate of the probability of death during follow-up was 43.3% for 1,334 patients receiving usual care and 35.8% for 1,533 ICD recipients. After adjustment for baseline differences, there was evidence that the survival benefit of ICDs in comparison to usual care depends on eGFR (posterior probability for null interaction P<0.001). The ICD was associated with survival benefit for patients with eGFR≥60 mL/min/1.73 m2 (adjusted HR, 0.49; 95% posterior credible interval, 0.24-0.95), but not for patients with eGFR<60 mL/min/1.73 m2 (adjusted HR, 0.80; 95% posterior credible interval, 0.40-1.53). eGFR did not modify the association between the ICD and rehospitalizations., Limitations: Few patients with eGFR<30 mL/min/1.73 m2 were available. Differences in trial-to-trial measurement techniques may lead to residual confounding., Conclusions: Reductions in baseline eGFR decrease the survival benefit associated with the ICD. These findings should be confirmed by additional studies specifically targeting patients with varying eGFRs., (Copyright © 2014 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Atrial fibrillation (AF) is generally considered a progressive disease, typically evolving from paroxysmal through persistent to 'permanent' forms, a process attributed to electrical and structural remodelling related to both the underlying disease and AF itself. Medical treatment has yet to demonstrate clinical efficacy in preventing progression. Large clinical trials performed to date have failed to show benefit of rhythm control compared with rate control, but these trials primarily included patients at late stages in the disease process. One possible explanation is that intervention at only an early stage of progression may improve prognosis. Evolving observations about the progressive nature of AF, along with the occurrences of major complications such as strokes upon AF presentation, led to the notion that earlier and more active approaches to AF detection, rhythm-reversion, and maintenance of sinus rhythm may be a useful strategy in AF management. Approaches to early and sustained rhythm control include measures that prevent development of the AF substrate, earlier catheter ablation, and novel antiarrhythmic drugs. Improved classifications of AF mechanism, pathogenesis, and remodelling may be helpful to enable patient-specific pathophysiological diagnosis and therapy. Potential novel therapeutic options under development include microRNA-modulation, heatshock protein inducers, agents that influence Ca(2+) handling, vagal stimulators, and more aggressive mechanism-based ablation strategies. In this review, of research into the basis and management of AF in acute and early settings, it is proposed that progression from paroxysmal to persistent AF can be interrupted, with potentially favourable prognostic impact., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.)