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Background: The Food and Drug Administration approved left atrial appendage occlusion with the Watchman device for patients who are at increased stroke risk and are suitable for oral anticoagulation but who have an appropriate reason to seek a nondrug alternative. These broad criteria raise the question of their interpretation in clinical practice. There is a lack of studies comprehensively evaluating the indications for Watchman implantation among a large series of patients from contemporary, real-world practice in the United States. Methods: We used the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry to identify Watchman procedures performed between 2016 and 2018. We assessed procedural indications for Watchman implantation in the United States and evaluated the association between procedural indications and in-hospital adverse events. Results: A total of 38 314 procedures were included. The mean patient age was 76.1±8.1 years, and 58.9% were men. The mean CHA 2 DS 2 -VASc score was 4.8±1.5, whereas the mean hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol (HAS-BLED) score was 3.0±1.1. Prior stroke or transient ischemic attack was reported in 40.2% and prior bleeding in 70.1%, with gastrointestinal bleeding being most common (41.9%). The most common site-reported procedural indications for Watchman implantation were increased thromboembolic risk (64.8%) and history of major bleed (64.3%), followed by high fall risk (35.5%). Most (71.9%) had ≥2 procedural indications. Patients with high fall risk had increased risk of in-hospital adverse events (adjusted OR, 1.12; P =0.025), but no other differences were found in the risk of in-hospital adverse events by procedural indication. Conclusions: Among patients in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry, the most common procedural indications for Watchman implantation were increased thromboembolic risk, history of major bleed, and high fall risk. A majority of patients had multiple procedural indications. High fall risk conferred a modestly increased risk of in-hospital adverse events.

Clinical events committee (CEC) evaluation is the standard approach for end point adjudication in clinical trials. Due to resource constraints, large registries typically rely on site-reported end points without further confirmation, which may preclude use for regulatory oversight.We developed a novel automated adjudication algorithm (AAA) for end point adjudication in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion (LAAO) Registry using an iterative process using CEC adjudication as the "gold standard." A ≥80% agreement rate between automated algorithm adjudication and CEC adjudication was prespecified as clinically acceptable. Agreement rates were calculated.A total of 92 in-hospital and 127 post-discharge end points were evaluated between January 1, 2016 and June 30, 2019 using AAA and CEC. Agreement for neurologic events was90%. Percent agreement for in-hospital and post-discharge events was as follows: ischemic stroke 95.7% and 94.5%, hemorrhagic stroke 97.8% and 96.1%, undetermined stroke 97.8% and 99.2%, transient ischemic attack 98.9% and 98.4% and intracranial hemorrhage 100.0% and 94.5%. Agreement was80% for major bleeding (83.7% and 90.6%) and major vascular complication (89.1% and 97.6%). With this approach,1% of site reported end points require CEC adjudication. Agreement remained very good during the period after algorithm derivation.An AAA-guided approach for end point adjudication was successfully developed and validated for the LAAO Registry. With this approach, the need for formal CEC adjudication was substantially reduced, with accuracy maintained above an 80% agreement threshold. After application specific validation, these methods could be applied to large registries and clinical trials to reduce the cost of event adjudication while preserving scientific validity.

ObjectiveOlder, relatively small studies identified female sex as a risk factor for adverse events after catheter ablation for atrial fibrillation (AF). We aimed to assess contemporary sex-based differences in baseline and procedural characteristics, adverse events, and quality of life among adults undergoing catheter ablation for AF.MethodsIn this observational cohort study, we evaluated those enrolled in the National Cardiovascular Data Registry AFib Ablation Registry between January 2016 and September 2020. Using logistic regression, we analysed the association between patient sex and in-hospital adverse events.ResultsAmong 58 960 adults (34.6% women) from 150 centres undergoing AF ablation by 706 physicians, women were older (68 vs 64 years, p1 day (adjusted OR (aOR) 1.41 (95% CI 1.33 to 1.49)), major adverse event (aOR 1.60 (95% CI 1.33 to 1.92)) and any adverse event (aOR 1.57 (95% CI 1.41 to 1.75)). Women had a higher risk of bradycardia requiring pacemaker, phrenic nerve damage, pericardial effusion, bleeding and vascular injury, but had no differences in death or acute pulmonary vein isolation.ConclusionsAmong almost 60 000 patients in the largest prospective registry of AF ablation procedures, female sex was independently associated with a higher risk of hospitalisation >1 day, adverse events, and reduced quality of life, although there were no differences in death or acute pulmonary vein isolation.

Pivotal trials of percutaneous left atrial appendage occlusion (LAAO) used specific postprocedure treatment protocols.This study sought to evaluate patterns of postprocedure care after LAAO with the Watchman device in clinical practice and compare the risk of adverse events for different discharge antithrombotic strategies.We evaluated patients in the LAAO Registry of the National Cardiovascular Data Registry who underwent LAAO with the Watchman device between 2016 and 2018. We assessed adherence to the full postprocedure trial protocol including standardized follow-up, imaging, and antithrombotic agents and then evaluated the most commonly used antithrombotic strategies and compared the rates and risk of adverse events at 45 days and 6 months by means of multivariable COX frailty regression.Among 31,994 patients undergoing successful LAAO, only 12.2% received the full postprocedure treatment protocol studied in pivotal trials; the most common protocol deviations were with discharge antithrombotic medications. The most common discharge medication strategies were warfarin and aspirin (36.9%), direct oral anticoagulant (DOAC) and aspirin (20.8%), warfarin only (13.5%), DOAC only (12.3%), and dual antiplatelet therapy (5.0%). In multivariable Cox frailty regression, the adjusted risk of any adverse event through the 45-day follow-up visit were significantly lower for discharge on warfarin alone (HR: 0.692; 95% CI: 0.569-0.841) and DOAC alone (HR: 0.731; 95% CI: 0.574-0.930) compared with warfarin and aspirin. Warfarin alone retained lower risk at the 6-month follow-up.In contemporary U.S. practice, practitioners rarely used the full U.S. Food and Drug Administration-approved postprocedure treatment protocols studied in pivotal trials of the Watchman device. Discharge after implantation on warfarin or DOAC without concomitant aspirin was associated with lower risk of adverse outcomes.

Implantable cardioverter-defibrillators (ICDs) are recommended for patients with cardiac sarcoidosis (CS) with an indication for pacing, prior ventricular arrhythmias, cardiac arrest, or left ventricular ejection fraction35%, but data on outcomes are limited.Using data from the National Cardiovascular Data Registry ICD Registry between April 1, 2010 and December 31, 2015, we evaluated a propensity matched cohort of CS patients implanted with ICDs versus non-ischemic cardiomyopathies (NICM). We compared mortality using Kaplan-Meier survival curves and Cox proportional hazards models.We identified 1,638 patients with CS and 8,190 propensity matched patients with NICM. The rate of death at 1 and 2 years was similar in patients with CS and patients with NICM (5.2% vs 5.4%, P = 0.75 and 9.0% vs 9.3%, P = 0.72, respectively). After adjusting for other covariates, patients with CS had similar mortality at 2 years after ICD implantations compared with NICM patients (RR 1.03, 95% CI 0.87-1.23). Among patients with CS, multivariable logistic regression identified 6 factors significantly associated with increased 2-year mortality: presence of heart failure (HR 1.92, 95% CI 1.44-3.22), New York Heart Association (NYHA) Class III heart failure (HR 1.68, 95% CI 1.16-2.45), NYHA Class IV heart failure (HR 3.08, 95% CI 1.49-6.39), atrial fibrillation/flutter (HR 1.66, 95% CI 1.17-2.35), chronic lung disease (HR 1.64, 95% CI 1.17-2.29), creatinine2.0 mg/dL (HR 4.07, 95% CI 2.63-6.30), and paced rhythm (HR 2.66, 95% CI 1.07-6.59).Mortality following ICD implantation was similar in CS patients compared with propensity matched NICM patients. Presence of heart failure, NYHA class, atrial fibrillation/flutter, chronic lung disease, renal dysfunction, and paced rhythm at time of implantation were all predictors of increased 2-year mortality among CS patients with ICDs.

Background Standardization of risk is critical in benchmarking and quality improvement efforts for percutaneous coronary interventions (PCIs). In 2018, the CathPCI Registry was updated to include additional variables to better classify higher-risk patients. Objectives This study sought to develop a model for predicting in-hospital mortality risk following PCI incorporating these additional variables. Methods Data from 706,263 PCIs performed between July 2018 and June 2019 at 1,608 sites were used to develop and validate a new full and pre-catheterization model to predict in-hospital mortality, and a simplified bedside risk score. The sample was randomly split into a development cohort (70%, n = 495,005) and a validation cohort (30%, n = 211,258). The authors created 1,000 bootstrapped samples of the development cohort and used stepwise selection logistic regression on each sample. The final model included variables that were selected in at least 70% of the bootstrapped samples and those identified a priori due to clinical relevance. Results In-hospital mortality following PCI varied based on clinical presentation. Procedural urgency, cardiovascular instability, and level of consciousness after cardiac arrest were most predictive of in-hospital mortality. The full model performed well, with excellent discrimination (C-index: 0.943) in the validation cohort and good calibration across different clinical and procedural risk cohorts. The median hospital risk-standardized mortality rate was 1.9% and ranged from 1.1% to 3.3% (interquartile range: 1.7% to 2.1%). Conclusions The risk of mortality following PCI can be predicted in contemporary practice by incorporating variables that reflect clinical acuity. This model, which includes data previously not captured, is a valid instrument for risk stratification and for quality improvement efforts.

Background We aimed to characterize the occurrence of major adverse cardiovascular and limb events (MACE and MALE) among patients with peripheral artery disease (PAD) undergoing peripheral vascular intervention (PVI), as well as associated factors in patients with chronic limb threatening ischemia (CLTI). Methods and Results Patients undergoing PVI in the American College of Cardiology’s (ACC) National Cardiovascular Data Registry’s PVI Registry who could be linked to Centers for Medicare and Medicaid Services data were included. The primary outcomes were MACE, MALE, and readmission within 1 month and 1 year following index CLTI‐PVI or non‐CLTI‐PVI. Cox proportional hazards regression was used to identify factors associated with the development of the primary outcomes among patients undergoing CLTI‐PVI. There were 1758 (49.7%) patients undergoing CLTI‐PVI and 1779 (50.3%) undergoing non‐CLTI‐PVI. By 1 year, MACE occurred in 29.5% of patients with CLTI (n=519), and MALE occurred in 34.0% of patients with CLTI (n=598). By 1 year, MACE occurred in 8.2% of patients with non‐CLTI (n=146), and MALE occurred in 26.1% of patients with non‐CLTI (n=465). Predictors of MACE at 1 year in CLTI‐PVI included end‐stage renal disease on hemodialysis, congestive heart failure, prior CABG, and severe lung disease. Predictors of MALE at 1 year in CLTI‐PVI included treatment of a prior bypass graft, profunda femoral artery treatment, end‐stage renal disease on hemodialysis, and treatment of a previously treated lesion. Conclusions Patients ≥65 years old undergoing PVI experience high rates of MACE and MALE. A range of modifiable and non‐modifiable patient factors, procedural characteristics, and medications are associated with the occurrence of MACE and MALE following CLTI‐PVI.

Background Readmission rates after acute myocardial infarction (AMI) and heart failure (HF) hospitalizations have decreased in the United States since the implementation of the Hospital Readmissions Reduction Program. Objectives This study was designed to examine the temporal trends of readmission and mortality after AMI and HF in Ontario, Canada, where reducing hospital readmissions has not had a policy incentive. Methods The cohort was comprised of AMI or HF patients 65 years of age or older who had been hospitalized from 2006 to 2017. Primary outcomes were 30-day readmission and post-discharge mortality. Secondary outcomes included in-hospital mortality, 30-day mortality from admission, and in-hospital mortality or 30-day mortality post-discharge. Adjusted monthly trends for each outcome were examined over the study period. Results Our cohorts included 152,808 AMI and 223,283 HF patients. Age- and sex-standardized AMI hospitalization rates in Ontario declined 32% from 2006 to 2017 while HF hospitalization rates declined slightly (9.1%). For AMI, risk-adjusted 30-day readmission rates declined from 17.4% in 2006 to 14.7% in 2017. All AMI risk-adjusted mortality rates also declined from 2006 to 2017 with 30-day post-discharge mortality from 5.1% to 4.4%. For HF, overall risk-adjusted 30-day readmission was largely unchanged from 2006 to 2014 at 21.9%, followed by a decline to 20.8% in 2017. Risk-adjusted 30-day post-discharge mortality declined from 7.1% in 2006 to 6.6% in 2017. Conclusions The patterns of outcomes in Ontario are consistent with the United States for AMI, but diverge for HF. For AMI and HF, admissions, readmissions, and mortality rates declined over this period. The reasons for the country-specific patterns for HF need further exploration.

Background As patients derive variable benefit from generator changes (GCs) of implantable cardioverter‐defibrillators (ICDs) with an original primary prevention (PP) indication, better predictors of outcomes are needed. Methods and Results In the National Cardiovascular Data Registry ICD Registry, patients undergoing GCs of initial non‐cardiac resynchronization therapy PP ICDs in 2012 to 2016, predictors of post‐GC survival and survival benefit versus control heart failure patients without ICDs were assessed. These included predicted annual mortality based on the Seattle Heart Failure Model, left ventricular ejection fraction (LVEF) >35%, and the probability that a patient's death would be arrhythmic (proportional risk of arrhythmic death [PRAD]). In 40 933 patients undergoing GCs of initial noncardiac resynchronization therapy PP ICDs (age 67.7±12.0 years, 24.5% women, 34.1% with LVEF >35%), Seattle Heart Failure Model–predicted annual mortality had the greatest effect size for decreased post‐GC survival ( P 35% had a lower Seattle Heart Failure Model–adjusted survival versus 23 472 control heart failure patients without ICDs (model interaction hazard ratio, 1.21 [95% CI, 1.11–1.31]). In patients undergoing GCs of initial noncardiac resynchonization therapy PP ICDs with LVEF ≤35%, the model indicated worse survival versus controls in the 21% of patients with a PRAD 65%. The association of the PRAD with survival benefit or harm was similar in patients with or without pre‐GC ICD therapies. Conclusions Patients who received replacement of an ICD originally implanted for primary prevention and had at the time of GC either LVEF >35% alone or both LVEF ≤35% and PRAD

The aim of this study was to compare outcomes among patients from the PROTECT-AF (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation) and PREVAIL (Evaluation of the WATCHMAN Left Atrial Appendage [LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) left atrial appendage occlusion (LAAO) trials with matched patients from the National Cardiovascular Data Registry LAAO Registry using patient-level data.Patients undergoing LAAO in clinical practice generally have more comorbidities than trial participants.Propensity-matched analyses, with up to 3 registry patients matched to each trial patient, were performed using Cox proportional hazards and Fine-Gray models.A total of 1,904 registry patients were matched to 667 trial LAAO patients; 1,010 registry patients were matched to 348 warfarin patients. Compared with registry patients, trial LAAO patients experienced more pericardial effusion requiring intervention (3.8% vs 0.6%, P 0.001), periprocedural ischemic stroke (0.9% vs 0.2%, P = 0.005), and failed device implantation (7.5% vs 3.6%, P 0.001). The 425-day risk of ischemic stroke in trial LAAO patients was higher than in registry patients (2.70% vs 1.21%; HR: 1.951; P = 0.03); warfarin patients had comparable rates of ischemic stroke compared with registry patients (1.15% vs 1.29%; HR: 0.728; P = 0.57). Hemorrhagic stroke risk was similar among trial LAAO and registry patients (P = 0.88). Hemorrhagic stroke risk was greater among warfarin patients versus registry patients (1.44% vs 0.20%; HR: 5.871, P = 0.03). Mortality was lower in trial LAAO patients than in registry patients (2.92% vs 6.23%; HR: 0.477; P = 0.004), a difference attributable to noncardiovascular deaths. Mortality was similar (P = 0.44) among trial warfarin (4.48%) and registry (5.86%) patients.In clinical practice, patients who meet trial criteria and undergo LAAO experience a lower risk of ischemic stroke, a similar risk of hemorrhagic stroke, and a higher risk of death after implant versus LAAO trial patients. (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation [PROTECT-AF], NCT00129545; Evaluation of the WATCHMAN Left Atrial Appendage [LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy [PREVAIL], NCT01182441).

BACKGROUND The Medtronic Sprint Fidelis® and Abbott Riata®/Riata ST® leads are at risk of failure and are subject to FDA recall. Comparative risks of various lead management strategies during elective generator change in a multi-center population are unknown. We aim to describe patients with functional, recalled ICD leads undergoing elective generator replacement and report outcomes according to lead management strategies. METHODS Using data from the NCDR ICD Registry, patients with a functioning Riata® or Fidelis® lead undergoing generator replacement are described according to lead management: reuse, abandon/replace, and extract/replace. Adjusted rates of death and pre-discharge complications are reported. RESULTS There were 13,144 generator replacement procedures involving a functioning, non-infected Riata® or Fidelis® lead (extraction n = 414, abandonment n = 427). Extraction patients were younger (mean 58 vs. 67 years) with fewer comorbidities than the reuse group. Maximum lead dwell time was similar between groups with average 94, 90, and 99 months in the extraction, abandonment, and reuse groups, respectively. In-hospital complications or mortality were more common in the extraction group (10.14%, 4.35%) compared with abandonment (1.64%, 0.47%) and reuse (0.22%, 0.07%). Compared with reuse, the adjusted odds of death or pre-discharge complication were significantly higher in the extraction group (OR 7.77 95% CI 2.42-24.95, p

Background: Prior studies on the use of multivessel percutaneous coronary intervention (MV PCI) for patients with ST-segment–elevation myocardial infarction (STEMI) and multivessel coronary artery disease have yielded heterogeneous results. The recent COMPLETE trial (Complete Versus Culprit-Only Revascularization Strategies to Treat Multivessel Disease After Early PCI for STEMI) demonstrated that MV PCI was superior to culprit-only PCI among patients with STEMI. It is unclear how these trial results apply to clinical decisions encountered in routine practice. Methods: We studied STEMI admissions among patients >65 years with multivessel disease and Centers for Medicare and Medicaid Services–linked data in the National Cardiovascular Data Registry CathPCI Registry from July 1, 2009 to December 31, 2017. MV PCI was defined as PCI to a nonculprit lesion ≤45 days of the index procedure. The primary outcome was the composite of death, myocardial infarction, and revascularization from 45 days through 1 year. To account for unmeasured confounders, an instrumental variable analysis was used to compare treatment strategies. The instrument was institutional rates of MV PCI. A falsification end point of postdischarge major bleeding was utilized to assess for residual confounding. Results: Of 56 332 admissions from 1102 institutions, 37.7% received MV PCI ≤45 days of index STEMI PCI. Of those undergoing MV PCI, 74.8% received complete revascularization. In unadjusted analysis, MV PCI was associated with a lower cumulative incidence of the composite outcome between 45 days and 1 year (13.9% versus 18.2% for non-MV PCI, P P =0.46). An association between MV PCI and the falsification end point of major bleeding was not observed (adjusted risk difference, −2.54% [95% CI, −5.30% to 0.22%]; P =0.07). Conclusions: In this large, nationwide analysis, we did not find benefit of MV PCI by 1 year among older STEMI patients. The clinical benefit of MV PCI may not extend equally outside of trials to include all patients, including those with more extreme ages and more complex decision-making.

Some patients with heart failure (HF) experience recovery of left ventricular (LV) systolic function by the end of their implantable cardioverter-defibrillator (ICD) generator battery life. Outcomes following generator replacement in this setting are poorly understood.We sought to describe outcomes following ICD generator replacement associated with recovery of LV systolic function.We evaluated 26,197 Medicare beneficiaries enrolled in the American College of Cardiology's National Cardiovascular Data Registry ICD Registry who underwent primary prevention ICD generator replacement between 2006 and 2009, stratified by LV ejection fraction (LVEF): reduced (LVEF ≤35%), partially recovered (LVEF35% and ≤50%), and recovered (LVEF50%).At the time of generator replacement, 1915 (7.3%) patients had recovered LVEF and 4576 (17.5%) had partially recovered LVEF. Periprocedural events were rare (1%) in all patients. In patients with reduced LVEF, the incidence of HF readmission and mortality at 3 years was 27.5% and 32.7%, respectively. In comparison, the rates of HF readmission and mortality were lower for patients with partially recovered LVEF (readmission: 15.9%; hazard ratio [HR] 0.66; 95% confidence interval [CI] 0.61-0.72; mortality: 23.0%; HR 0.82; 95% CI 0.76-0.87) and those with recovered LVEF (readmission: 12.2%; HR 0.55; 95% CI 0.48-0.63; mortality: 18.2%; HR 0.72; 95% CI 0.64-0.80).Patients with partially recovered and recovered LVEF have lower risks of mid-term adverse outcomes than do those with reduced LVEF following ICD generator replacement. Approximately 3 in 4 patients continue to have reduced LVEF at the time of generator replacement and are at high risk of HF readmission and mortality. These data highlight the prognostic associations of LVEF in patients undergoing generator replacement as well as the clinical encounter for generator replacement as an opportunity to identify those at increased risk of adverse outcomes.

Cardiac resynchronization therapy with defibrillator (CRT-D) implantation involves left ventricular (LV) lead placement for biventricular pacing and is more complex than implantable cardioverter-defibrillator (ICD)-only implantation. Differences in the prescription of CRT-D versus ICD may result from clinician biases based on patient body habitus, and body habitus may be associated with LV lead implantation failure. We sought to evaluate whether patient body mass index (BMI) was associated with planned use and implantation failure of CRT-D therapy. We studied all patients enrolled in the National Cardiovascular Data Registry ICD Registry who met standard CRT-D criteria and received either an ICD or CRT-D between 2010 and 2012. BMI was categorized based on World Health Organization classification. Using hierarchical logistic regression, two multivariate models adjusted for patient demographic and clinical characteristics were fit based on the following outcome variables: (1) planned implantation with CRT-D versus ICD and (2) failed versus successful LV lead placement. Of 337,547 patients, 41,872 met inclusion criteria for the first analysis and 35,186 met criteria for the second analysis. After multivariable adjustment, patients with extreme (BMI > 40 kg/m2) obesity were less likely to receive guideline-concordant CRT-D compared with patients with normal weight (adjusted odds ratio (AOR), 0.86; 95% confidence interval (CI), 0.75–0.99; p = 0.04). Extreme (BMI > 40 kg/m2) obesity was associated with higher odds of failed LV lead placement (AOR, 1.35; 95% CI, 1.07–1.72, p = 0.01). Compared with normal weight patients, extremely obese (BMI > 40 kg/m2) CRT-D eligible patients were less likely to be prescribed CRT-D and were at higher odds for failed LV lead placement.

Background: Coronary artery bypass graft (CABG) surgery is a focus of bundled and alternate payment models that capture outcomes up to 90 days postsurgery. While clinical registry risk models perform well, measures encompassing mortality beyond 30 days do not currently exist. We aimed to develop a risk-adjusted hospital-level 90-day all-cause mortality measure intended for assessing hospital performance in payment models of CABG surgery using administrative data. Methods: Building upon Centers for Medicare and Medicaid Services hospital-level 30-day all-cause CABG mortality measure specifications, we extended the mortality timeframe to 90 days after surgery and developed a new hierarchical logistic regression model to calculate hospital risk-standardized 90-day all-cause mortality rates for patients hospitalized for isolated CABG. The model was derived from Medicare claims data for a 3-year cohort between July 2014 to June 2017. The data set was randomly split into 50:50 development and validation samples. The model performance was evaluated with C statistics, overfitting indices, and calibration plot. The empirical validity of the measure result at the hospital level was evaluated against the Society of Thoracic Surgeons composite star rating. Results: Among 137 819 CABG procedures performed in 1183 hospitals, the unadjusted mortality rate within 30 and 90 days were 3.1% and 4.7%, respectively. The final model included 27 variables. Hospital-level 90-day risk-standardized mortality rates ranged between 2.04% and 11.26%, with a median of 4.67%. C statistics in the development and validation samples were 0.766 and 0.772, respectively. We identified a strong positive correlation between 30- and 90-day risk-standardized mortality rates, with a regression slope of 1.09. Risk-standardized mortality rates also showed a stepwise trend of lower 90-day mortality with higher Society of Thoracic Surgeons composite star ratings. Conclusions: We present a measure of hospital-level 90-day risk-standardized mortality rates following isolated CABG. This measure complements Centers for Medicare and Medicaid Services’ existing 30-day CABG mortality measure by providing greater insight into the postacute recovery period. It offers a balancing measure to ensure efforts to reduce costs associated with CABG recovery and rehabilitation do not result in unintended consequences.

Introduction: Whether to reuse, abandon, or extract functioning, recalled ICD leads at the time of generator replacement is an area of uncertainty as lead failure is more common following generator replacement, and long term failure rates of recalled ICD leads are unknown. We sought to evaluate outcomes following various lead management strategies at the time of generator replacement. Hypothesis: Functional St. Jude Riata and Medtronic Sprint Fidelis leads at the time of elective generator replacement are more frequently reused than replaced, and extracting them poses significant procedural risk. Methods: We queried the NCDR ICD Registry for Medicare patients undergoing elective generator replacement with a normal Fidelis or Riata lead from 2010-2016 and categorized patients based on the fate of the recalled lead: reused, abandoned, or extracted. We report pre-discharge complications by group. Results: There were 9937 generator replacement patients between 2010-2016 with a functioning Riata or Fidelis lead in which lead management was reported. The lead was reused in 9806 (98%) patients, extracted in 55 (0.6%), and abandoned in 76 (0.8%). Compared with the reused group, extracted patients were >10 years younger, had less heart failure and fewer comorbidities. In-hospital death occurred in 4 (7.3%) patients in the extracted group and 7 (0.07%) in the reused group (P Conclusions: At the time of generator replacement, a small percentage of functional Riata and Fidelis leads were extracted. Even in this highly selected extraction population, extraction posed significant risk of in-hospital mortality and severe complications. Future work will help clarify whether these peri-procedural risks may be justified by improved medium and long term outcomes.

Introduction: Left atrial appendage occlusion (LAAO) has emerged as an alternative to anticoagulation in select patients with atrial fibrillation (AF), however women are underrepresented in trial data and sex-specific sub analyses are limited. Hypothesis: Women will be more likely than men to experience adverse events following left atrial appendage occlusion (LAAO) procedure. Methods: Using the National Cardiovascular Data Registry LAAO Registry, patients undergoing Watchman implantation between January 2016 and December 2018 were included. Unadjusted and multivariable adjusted logistic regression analyses were performed to assess the association between gender and in-hospital outcomes, including any complication, major adverse events (pericardial effusion, major bleeding, stroke, and device embolization), hospital stay > 1 day, and mortality. Results: A total of 20,388 (41.3%) women and 28,969 (58.7%) men underwent Watchman implantation. Compared with male patients, women were older (76.5 vs 75.8 years, p1 day (OR 1.46, 95% CI 1.38 - 1.54, p Conclusion: Women have a significantly higher risk than men of in-hospital adverse events and mortality following Watchman implantation. Further examination of the risk-benefit relationship of LAAO in women is warranted.

Importance After disparate results from observational and small randomized studies, the COMPLETE trial demonstrated superiority of multivessel (MV) percutaneous coronary intervention (PCI) over culprit-only PCI for ST-elevation myocardial infarction (STEMI). Objective To describe temporal trends and institutional variation of MV PCI use for STEMI in the United States to inform how new evidence may influence clinical practice. Design, setting, and participants This cohort study included STEMI admissions involving MV disease from 1598 institutions in the National Cardiovascular Data Registry CathPCI Registry from the third quarter of 2009 to the first quarter of 2018. An MV PCI was defined as a PCI to a nonculprit lesion within 45 days of the index procedure. Exposures Multivessel PCI, defined as placement of coronary stents in 2 or more major epicardial vessels or the staged placement of 1 or more coronary stents in a major epicardial vessel distinct from the index culprit vessel, within 45 days of the index PCI. Main outcomes and measures Outcomes included the proportional use of MV PCI among STEMI admissions with MV disease, and the timing of MV PCI (an index procedure, a staged procedure during index hospitalization, or a postdischarge procedure within 45 days). Results Among 359 879 admissions with STEMI and MV disease, MV PCI was performed in 38.5% (n = 138 380; mean [SD] age of patients, 62.3 [12.3] years; 102 266 men [73.9%]) within 45 days. Of those receiving MV PCIs, 30.8% (n = 42 629) had a procedure performed during the index procedure, 31.6% (n = 43 696) as a staged procedure during the index hospitalization, and 37.6% (n = 52 055) within 45 days of discharge. Complete revascularization of all diseased arteries was performed in 76.2% (n = 105 389). From the third quarter of 2009 to the second quarter of 2013, MV PCI use declined by 10%, from 42.7% (3230 of 7572 cases) to a nadir of 32.7% (3386 of 10 342 cases), followed by an increase to 44.0% (5062 of 11 497 cases) by the fourth quarter of 2017. During this time, there was a 13.6% decline in use of postdischarge staged MV PCI (from 23.4% of STEMI cases [1772 of 7572 cases] in the third quarter of 2009 to 9.9% [1094 of 11 171 cases] in the fourth quarter of 2014) and an 12.5% increase in MV PCI performed during the index admission (from 19.3% [1458 of 7572 cases] in the third quarter of 2009 to 31.8% [3557 of 11 171 cases] in the first quarter of 2018). Multivessel PCI use varied substantially across institutions, with a median use of 37.9% (interquartile range, 30.0%-46.5%). Conclusions and relevance In this large, nationwide analysis, MV PCI use for patients with STEMI has been increasing through early 2018 but was used in the minority of patients and with wide variability across US institutions. The adoption of new trial results into guidelines and practice may further promote the growth of MV PCI.

Background Outcomes data in patients with cardiac amyloidosis after implantable cardioverter‐defibrillator (ICD) implantation are limited. We compared outcomes of patients with ICDs implanted for cardiac amyloidosis versus nonischemic cardiomyopathies (NICMs) and evaluated factors associated with mortality among patients with cardiac amyloidosis. Methods and Results Using National Cardiovascular Data Registry’s ICD Registry data between April 1, 2010 and December 31, 2015, we created a 1:5 propensity‐matched cohort of patients implanted with ICDs with cardiac amyloidosis and NICM. We compared mortality between those with cardiac amyloidosis and matched patients with NICM using Kaplan‐Meier survival curves and Cox proportional hazards models. We also evaluated risk factors associated with 1‐year mortality in patients with cardiac amyloidosis using multivariable Cox proportional hazards regression models. Among 472 patients with cardiac amyloidosis and 2360 patients with propensity‐matched NICMs, 1‐year mortality was significantly higher in patients with cardiac amyloidosis compared with patients with NICMs (26.9% versus 11.3%, P 2.5 (HR, 4.34; 95% CI, 2.72–6.93). Conclusions Mortality after ICD implantation is significantly higher in patients with cardiac amyloidosis than in patients with propensity‐matched NICMs. Factors associated with death among patients with cardiac amyloidosis include prior syncope, ventricular tachycardia, cerebrovascular disease, diabetes mellitus, and impaired renal function.

Background: Although increased age is associated with higher systolic blood pressure (SBP) in general, there may be variation across individuals in how SBP changes over time. The goal of this paper is to identify heterogeneity in SBP trajectories among young adults with similar initial values and identify personal characteristics associated with different trajectory patterns. This may have important implications for prevention and prognosis. Methods: A cohort of 12,468 individuals aged 18–35 years in the Qingdao Port Cardiovascular Health Study in China was followed yearly during 2000–2011. Individuals were categorized into three strata according to their baseline SBP: ≤110 mmHg, 111–130 mmHg, and >130 mmHg. Within each stratum, group-based trajectory analyses were conducted to identify distinct SBP trajectory patterns, and their association with sociodemographic and baseline health characteristics was assessed by ordinal logistic regression. Results: Five distinct groups of individuals exhibiting divergent patterns of increasing, stable or decreasing SBP trends were identified within each stratum. This is a first report to identify a subgroup with decreasing trend in SBP. Individuals with more advanced age, having less than high school education, family history of cardiovascular diseases, greater body mass index, greater waist circumference, and hyperlipidemia at baseline were more likely to experience trajectories of higher SBP within each stratum. Conclusions: The diverging trajectories among young adults with similar initial SBP highlight the need for prevention and feasibility of effective blood pressure control, while the identified risk factors may inform targeted interventions.

BACKGROUND: Patients with heart failure having a low expected probability of arrhythmic death may not benefit from implantable cardioverter defibrillators (ICDs). OBJECTIVE: The objective was to validate models to identify cardiac resynchronization therapy (CRT) candidates who may not require CRT devices with ICD functionality. METHODS: Heart failure (HF) patients with CRT-Ds and non-CRT ICDs from the National Cardiovascular Data Registry and others with no device from 3 separate registries and 3 heart failure trials were analyzed using multivariable Cox proportional hazards regression for survival with the Seattle Heart Failure Model (SHFM; estimates overall mortality) and the Seattle Proportional Risk Model (SPRM; estimates proportional risk of arrhythmic death). RESULTS: Among 60,185 patients (age 68.6±11.3 years, 31.9% female) meeting CRT-D criteria, 38,348 had CRT-Ds, 11,389 had non-CRT ICDs, and 10,448 had no device. CRT-D patients had a prominent adjusted survival benefit (HR 0.52, 95% CI 0.50–0.55, pmedian had substantially more ICD-attributable benefit (absolute risk reduction of 2.6%/year combined; p

OBJECTIVES This study was designed to examine the association between adopting the transradial approach for percutaneous coronary intervention (PCI) and rates of vascular complications following transfemoral PCI. BACKGROUND Recent studies raised concerns that operators adopting the transradial approach may lose their transfemoral access skills and experience increased rates of vascular complications. METHODS Retrospective analysis of data from the NCDR CathPCI Registry to examine the rates of vascular complications among physicians who were femoral operators (>90% of cases) in 2010-2011 and later adopted the transradial approach to PCI among low-, intermediate-, or high-level adopters (≤33%, 34-66%, and >66%, respectively) in 2014-2015. Propensity score matching was used to control for confounding factors. RESULTS A total of 1,704,708 procedures performed by 4,697 operators were included. Most operators were low-level adopters (80.7%), followed by intermediate (15.7) and high-level adopters (3.6%). Compared to the preadoption period, vascular complications of transfemoral PCIs following transradial adoption increased among low-level adopters (1.29%-1.59%, adjusted OR [95% CI]: 1.24[1.20-1.28], P

Patients with childhood heart disease are living longer and entering adulthood, and may undergo implantable cardioverter-defibrillator (ICD) implantation to reduce the risk of sudden death. We evaluated the characteristics of adult patients with congenital heart disease or left ventricular noncompaction cardiomyopathy (LVNC) in the National Cardiovascular Disease Registry ICD Registry and determined ICD-related in-hospital complications. Patients with LVNC or transposition of the great arteries, tetralogy of Fallot, Ebstein's anomaly, atrial septal defect, ventricular septal defect, or common ventricle were identified in the registry. In-hospital complications were compared among different diagnoses using the chi-square test for categorical variables and the F-test in analyses of variance for continuous variables. A total of 3,077 patients were identified. The mean age was 48.0 ± 16.0 years, and 39.9% were female. Single-chamber ICDs were implanted in 25.2%, dual chamber in 41.9%, and cardiac resynchronization in 30.8%. Intraprocedural or postprocedural complications occurred in 70 patients (2.3%); there were 6 in-hospital deaths (0.2%). The most frequent complications were acute lead dislodgments, pneumothorax, and hematomas. Patients with Ebstein's anomaly had the greatest complication rate (8.3%, p = 0.03). The complication rate was 1.55% in single-chamber devices, 1.86% in dual chamber, and 3.5% in cardiac resynchronization (p < 0.001). For initial implants, the complication rate was 2.55%, 1.62% in generator replacements, and 8.77% in lead revisions (p = 0.001). In conclusion, in this large contemporary adult cohort of congenital heart disease and LVNC patients who underwent ICD implant procedures, periprocedural complication rates were low. Lead-related risks predominated.

Background and Purpose— The Centers for Medicare & Medicaid Services publicly reports a hospital-level stroke mortality measure that lacks stroke severity risk adjustment. Our objective was to describe novel measures of stroke mortality suitable for public reporting that incorporate stroke severity into risk adjustment. Methods— We linked data from the American Heart Association/American Stroke Association Get With The Guidelines-Stroke registry with Medicare fee-for-service claims data to develop the measures. We used logistic regression for variable selection in risk model development. We developed 3 risk-standardized mortality models for patients with acute ischemic stroke, all of which include the National Institutes of Health Stroke Scale score: one that includes other risk variables derived only from claims data (claims model); one that includes other risk variables derived from claims and clinical variables that could be obtained from electronic health record data (hybrid model); and one that includes other risk variables that could be derived only from electronic health record data (electronic health record model). Results— The cohort used to develop and validate the risk models consisted of 188 975 hospital admissions at 1511 hospitals. The claims, hybrid, and electronic health record risk models included 20, 21, and 9 risk-adjustment variables, respectively; the C statistics were 0.81, 0.82, and 0.79, respectively (as compared with the current publicly reported model C statistic of 0.75); the risk-standardized mortality rates ranged from 10.7% to 19.0%, 10.7% to 19.1%, and 10.8% to 20.3%, respectively; the median risk-standardized mortality rate was 14.5% for all measures; and the odds of mortality for a high-mortality hospital (+1 SD) were 1.51, 1.52, and 1.52 times those for a low-mortality hospital (−1 SD), respectively. Conclusions— We developed 3 quality measures that demonstrate better discrimination than the Centers for Medicare & Medicaid Services’ existing stroke mortality measure, adjust for stroke severity, and could be implemented in a variety of settings.

Aims ST-segment elevation myocardial infarctions (STEMI) in China and other low- and middle-income countries outnumber non-ST-segment elevation myocardial infarctions (NSTEMI). We hypothesized that the STEMI predominance was associated with lower biomarker use and would vary with hospital characteristics. Methods and results We hypothesized that the STEMI predominance was associated with lower biomarker use and would vary with hospital characteristics. Using data from the nationally representative China PEACE-Retrospective AMI Study during 2001, 2006, and 2011, we compared hospital NSTEMI proportion across categories of use of any cardiac biomarker (CK, CK-MB, or troponin) and troponin, as well as across region, location, level, and teaching status. Among 15 416 acute myocardial infarction (AMI) patients, 14% had NSTEMI. NSTEMI patients were older, more likely female, and to have comorbidities. Median hospital NSTEMI proportion in each study year was similar across categories of any cardiac biomarker use, troponin, region, location, level, and teaching status. For instance, in 2011 the NSTEMI proportion at hospitals without troponin testing was 11.2% [inter quartile range (IQR) 4.4–16.7%], similar to those with ≥ 75% troponin use (13.0% [IQR 8.7–23.7%]) (P-value for difference 0.77). Analysed as continuous variables there was no relationship between hospital NSTEMI proportion and proportion biomarker use. With troponin use there was no relationship in 2001 and 2006, but a modest correlation in 2011 (R = 0.16, P = 0.043). Admissions for NSTEMI increased from 0.3/100 000 people in 2001 to 3.3/100 000 people in 2011 (P-value for trend Conclusion STEMI is the dominant presentation of AMI in China, but the proportion of NSTEMI is increasing. Biomarker use and hospital characteristics did not account for the low NSTEMI rate. Clinical trial registration www.clinicaltrials.gov (NCT01624883).

Background Clinical trials of implantable cardioverter-defibrillators (ICDs) for secondary prevention of sudden cardiac death were conducted nearly 2 decades ago and enrolled few older patients. Objectives This study assessed morbidity and mortality of older patients receiving ICDs for secondary prevention in contemporary clinical practice. Methods We identified 12,420 Medicare beneficiaries from the National Cardiovascular Data Registry ICD Registry undergoing first-time secondary prevention ICD implantation between 2006 and 2009 in 956 U.S. hospitals. Risks of death, hospitalization, and admission to a skilled nursing facility (SNF) were assessed over 2 years in age strata (65 to 69, 70 to 74, 75 to 79, and ≥80 years of age) using Medicare claims. The adjusted association between age and outcomes was evaluated using multivariable models. Results The mean age was 75 years at the time of implantation; 25.3% were Conclusions Almost 4 in 5 older patients receiving a secondary prevention ICD survives at least 2 years. High hospitalization and SNF admission rates, particularly among the oldest patients, identify substantial care needs after device implantation.

There are little data about the prevalence and safety of DFT testing in pediatric populations. We analyzed the predictors and outcomes of defibrillation threshold (DFT) testing at the time of implantable cardioverter-defibrillator (ICD) implant and factors associated with inadequate defibrillation safety margin (DSM) in pediatric patients.We performed a retrospective analysis of initial transvenous ICD implantations in the National Cardiovascular Data Registry (NCDR) ICD Registry of patients ≤21 years. DSM was defined as the lowest successful energy tested10 J than the maximum output of the ICD. Subjects were followed to hospital discharge.Of all ICD recipients (n = 3943), DFT testing was performed in 64.0% (n = 2522) though decreased over time. In those with DFT data available (n = 2500), an inadequate DSM occurred in 13.6% (n = 339). After multivariable adjustment, DFT testing was not associated with in-hospital complications or death (OR 0.789, 95% CI 0.579-1.076), but was associated with lower odds of prolonged hospital stay (3 days) (OR 0.543, 95% CI 0.436-0.677). An inadequate DSM was associated with an increased risk of complications or death (OR 1.893, 95% CI 1.203-2.979) but not with a prolonged hospital stay (OR 1.307, 95% CI 0.878-1.947).In the largest dataset of DFT testing in pediatric ICD recipients, we found that DFT testing use decreased over time and was not associated with an increase in in-hospital complications in pediatric patients. An inadequate DSM, however, was associated with a higher rate of in-hospital complications or death.

Background: Patients undergoing implantable cardioverter-defibrillator (ICD) implantations have high rates of long-term device-related complications and reoperations. Whether physician specialty training is associated with differences in long-term outcomes following ICD implantation is unclear. Methods and Results: We linked data from the National Cardiovascular Data Registry ICD Registry with Medicare fee-for-service claims to identify physicians who performed ≥10 index ICDs from 2006 to 2009. We used data from the American Board of Medical Specialties to group the specialty of the implanting physician into mutually exclusive categories: electrophysiologists, interventional cardiologists, general cardiologists, thoracic surgeons, and other specialties. Primary outcomes were long-term device-related complications requiring reoperations or hospitalizations and reoperations for reasons other than complications. We compared the cumulative incidence rates and case-mix adjusted rates of long-term outcomes of index ICD implantations across physician specialties. Our analysis had a median follow-up of 47 months and included 107 966 index ICD implantations. Electrophysiologists had the lowest rates of incident long-term device-related complications (14.1%; interventional cardiologists, 15.3%; general cardiologists, 15.4%; thoracic surgeons, 16.4%; other specialists, 15.2%; P P P P =0.07). Compared to patients with implantations performed by electrophysiologists, patients with implantations performed by general cardiologists and thoracic surgeons were at higher risk of reoperation for noncomplication causes (relative risk for general cardiologists: 1.10 [1.05–1.15]; thoracic surgeons: 1.16 [1.00–1.33]; both P Conclusions: Patients with ICD implantations performed by electrophysiologists had the lowest risks of having long-term device-related complications and reoperations for noncomplication causes. Consideration of physician specialty before ICD implantation may represent an opportunity to minimize long-term adverse outcomes.

Background Despite improvements on individual process of care measures for acute myocardial infarction (AMI), little is known about performance on a composite measure of AMI care that assesses the delivery of many components of high-quality AMI care. We sought to examine trends in patient- and hospital-level performance on a composite defect-free care measure, identify disparities in the performance across sociodemographic groups, and identify opportunities to further improve quality and outcomes. Methods and Results We calculated the proportion of patients in the National Cardiovascular Data Registry–Acute Coronary Treatment and Intervention Outcomes Network Registry–Get With The Guidelines (now known as the Chest Pain - Myocardial Infarction Registry) between January 1, 2010, and December 31, 2017, receiving defect-free AMI care including guideline-recommended pharmacotherapy, timely provision of medical and reperfusion therapy, assessment of ventricular function, referral to cardiac rehabilitation, and smoking cessation counseling for patients with AMI. A total of 522 800 patients at 222 hospitals were included. Overall, the proportion of patients receiving defect-free care significantly increased from 66.0% in 2010 to 77.1% in 2017 ( P P P P P Conclusions Despite improvements in the proportion of patients with AMI receiving defect-free care overall and across sociodemographic groups, nearly 1 in 4 patients in 2017 still did not receive optimal care and absolute performance was consistently lower among older patients, women, black, and Hispanic patients. Composite measures of cardiovascular care, which assess the delivery of several evidence-based processes of care, can illuminate opportunities to improve the quality of care beyond that provided by conventional process measures.

Background The Hospital Readmissions Reduction Program (HRRP) has been associated with reduced 30-day readmissions for acute myocardial infarction (AMI) and heart failure (HF). Objectives The purpose of this study was to test whether this 30-day readmission reduction is a manifestation of practices that defer or avoid hospitalizations beyond the 30-day period. Methods At all U.S. hospitals under HRRP, the authors calculated daily readmission rates for elderly Medicare fee-for-service beneficiaries through day-60 post-discharge following a hospitalization for AMI and HF—the 2 target cardiovascular conditions—as well as pneumonia in July 2008 to June 2016. The authors applied a robust bias-corrected nonparametric regression approach to evaluate for discontinuities in rates around day 30. Results The authors identified 3,256 eligible hospitals, with median readmission rates in the days 1 to 30 and 31 to 60 post-discharge of 19.6% (interquartile range [IQR]: 16.7% to 22.9%) and 7.8% (IQR: 6.5% to 9.4%) for AMI, 23.0% (IQR: 20.6% to 25.3%) and 11.4% (IQR: 10.2% to 12.6%) for HF, and 17.5% (IQR: 15.4% to 19.8%) and 8.3% (IQR: 7.3% to 9.3%) for pneumonia, respectively. Daily readmission rates decreased across most of the 60 post-discharge days, with no discontinuities in the local polynomial regression for readmission at the 30-day mark, with a >95% power to detect 0.1% difference for each outcome across post-discharge day 30. Similarly, there was no discontinuity in mortality at 30 days post-discharge, or for either outcome at hospitals that incurred readmission penalties. Conclusions There was no evidence that clinicians adopted strategies that specifically deferred admissions or affected mortality in the 30-day period after discharge. The findings are consistent with the institution of strategies that generally affected readmission risk after discharge.

Aims The prognosis of patients with MINOCA (myocardial infarction with non-obstructive coronary arteries) is poorly understood. We examined major adverse cardiac events (MACE) defined as all-cause mortality, re-hospitalization for acute myocardial infarction (AMI), heart failure (HF), or stroke 12-months post-AMI in patients with MINOCA versus AMI patients with obstructive coronary artery disease (MICAD). Methods and results Multicentre, observational cohort study of patients with AMI (≥65 years) from the National Cardiovascular Data Registry CathPCI Registry (July 2009–December 2013) who underwent coronary angiography with linkage to the Centers for Medicare and Medicaid (CMS) claims data. Patients were classified as MICAD or MINOCA by the presence or absence of an epicardial vessel with ≥50% stenosis. The primary endpoint was MACE at 12 months, and secondary endpoints included the components of MACE over 12 months. Among 286 780 AMI admissions (276 522 unique patients), 16 849 (5.9%) had MINOCA. The 12-month rates of MACE (18.7% vs. 27.6%), mortality (12.3% vs. 16.7%), and re-hospitalization for AMI (1.3% vs. 6.1%) and HF (5.9% vs. 9.3%) were significantly lower for MINOCA vs. MICAD patients (P < 0.001), but was similar between MINOCA and MICAD patients for re-hospitalization for stroke (1.6% vs. 1.4%, P = 0.128). Following risk-adjustment, MINOCA patients had a 43% lower risk of MACE over 12 months (hazard ratio = 0.57, 95% confidence interval 0.55–0.59), in comparison to MICAD patients. This pattern was similar for adjusted risks of the MACE components. Conclusion This study confirms an unfavourable prognosis in elderly patients with MINOCA undergoing coronary angiography, with one in five patients with MINOCA suffering a major adverse event over 12 months.

This prospective study assessed whether gender differences in health insurance help explain gender differences in delay in seeking care for US patients with acute myocardial infarction (AMI). We also assessed gender differences in such prehospital delay for AMI in Spain, a country with universal insurance. We used data from 2,951 US and 496 Spanish patients aged 18–55 years with AMI. US patients were grouped by insurance status: adequately insured, underinsured, or uninsured. For each country, we assessed the association between gender and prehospital delay (symptom onset to hospital arrival). For the US cohort, we modeled the relationship between insurance groups and delay of >12 hours. US women were less likely than men to be uninsured, but more likely to be underinsured and a larger proportion of women than men experienced delays of >12 hours (38% versus 29%). We found no association between insurance status and delays of >12 hours in men or women. Only 17.3% of Spanish patients had delays of >12 hours and there were no significant gender differences. In conclusion, women were more likely than men to delay, though it was not explained by differences in insurance status. The lack of gender differences in prehospital delays in Spain suggests that these differences may vary by health care system and culture. Keywords: Prehospital delay, acute myocardial infarction, health insurance, multinational study

In CULPRIT-SHOCK, multivessel (MV)-PCI in AMI with cardiogenic shock (CS) led to higher mortality than culprit-only PCI. To address high rates of mortality, we evaluate temporal patterns and variation in PCI strategies in AMI and CS at US hospitals. In NCDR CathPCI during Jul 2009- Mar 2018, we

Background— We examined the association between the use of remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICD) and all-cause mortality and rehospitalization among patients undergoing initial ICD implant. Methods and Results— A limited data set was constructed from Boston Scientific ALTITUDE Registry and National Cardiovascular Data Registry ICD Registry between January 2006 and March 2010. Vital status was determined using the Social Security Death Master File. All-cause mortality up to 3 years was compared in patients who used RPM with those who did not use RPM. Time-dependent frailty Cox models quantified the association between RPM use and all-cause mortality. Analyses were repeated in subgroups based on age, sex, race, ICD type, indication, and cardiomyopathy pathogenesis. Similar methodology examined the association between RPM use and all-cause rehospitalization in patients enrolled in Medicare fee-for-service patients ≥65 years. The study cohort (n=37 742, age 67±13, 72% male) had a 3-year mortality of 20.9% (median follow-up 832 days). In multivariable analyses, patients using RPM (n=22 023, 58%) had lower risk of mortality compared with those not using RPM (hazard ratio 0.67, 95% confidence interval 0.64–0.71, P P Conclusions— Among patients undergoing initial ICD implant, RPM use is associated with significantly lower risk of adverse outcomes.

Background— In 2010, the National Cardiovascular Data Registry enhanced pediatric, nonatherosclerotic structural heart disease and congenital heart disease (CHD) data collection. This report characterizes CHD and pediatric patients undergoing implantable cardioverter defibrillator implantation. Methods and Results— In this article, we report implantable cardioverter defibrillator procedures (April 2010 to December 2012) in the registry for 2 cohorts: (1) all patients with CHD (atrial septal defect, ventricular septal defect, tetralogy of Fallot, Ebstein anomaly, transposition of the great vessels, and common ventricle) and (2) patients P =0.05) and nontransvenous height (167.1±18.9 cm; range, 53–193 cm versus 170.4±13.1 cm; range, 61–203 cm; P Conclusions— Primary prevention exceeds secondary prevention for CHD and pediatrics. Nontransvenous lead patients were younger, with higher rates of transposition of the great vessels and common ventricle patients compared with transvenous lead patients.

Supplemental Digital Content is available in the text., Background: Amid national efforts to improve the quality of care for people with cardiovascular disease in China, the use of traditional Chinese medicine (TCM) is increasing, yet little is known about its use in the early management of acute myocardial infarction (AMI). Methods and Results: We aimed to examine intravenous use of TCM within the first 24 hours of hospitalization (early IV TCM) for AMI. Data come from the China Patient-centered Evaluative Assessment of Cardiac Events Retrospective Study of Acute Myocardial Infarction, restricted to a large, representative sample of Western medicine hospitals throughout China (n=162). We conducted a chart review of randomly sampled patients with AMI in 2001, 2006, and 2011, comparing early intravenous TCM use across years, predictors of any early intravenous TCM use, and association with in-hospital bleeding and mortality. From 2001 to 2011, early intravenous TCM use increased (2001: 38.2% versus 2006: 49.1% versus 2011: 56.1%; P

Background: It is unknown if financial pressures to reduce hospital readmission rates following passage of the Affordable Care Act (ACA) have had the unintended effect of increasing mortality rates after hospitalization. We therefore examined correlations between paired changes in hospital 30-day readmission rates and 30-day mortality rates among Medicare fee-for-service beneficiaries hospitalized with heart failure (HF), acute myocardial infarction (AMI), or pneumonia from 2008 to 2014. Methods: We used linear regression to calculate monthly changes in hospitals’ 30-day risk-adjusted readmission rates (RARRs) and 30-day risk-adjusted mortality rates (RAMRs) after discharge for HF, AMI, and pneumonia from 2008 to 2014. Adjustment was made for patient age, sex, comorbidities, hospital length of stay, and season. We then examined the correlation of hospitals’ paired monthly changes in 30-day RARRs and monthly changes in 30-day RAMRs after discharge. Results: From 2008 to 2014, we identified 2,962,554, 1,229,939, and 2,544,530 hospitalizations for HF, AMI, and pneumonia at 5,016, 4,772, and 5,057 hospitals, respectively. Hospital 30-day RARRs declined for all three conditions from 2008 to 2014; the monthly change in RARRs was -0.053 (95% CI -0.055, -0.051) for HF, -0.044 (95% CI -0.047, -0.041) for AMI, and -0.033 (95% CI -0.035, -0.031) for pneumonia. In contrast, the monthly change in hospital 30-day RAMRs after discharge varied by admitting condition and was 0.008 (95% CI 0.007, 0.010) for HF, -0.003 (95% CI -0.006, -0.001) for AMI, and 0.001 (95% CI -0.001, 0.003) for pneumonia. The correlation between monthly changes in hospitals’ 30-day RARRs and 30-day RAMRs after discharge was 0.060 for HF (p Conclusion: Changes in hospital readmission rates for HF, AMI, and pneumonia were poorly correlated with changes in mortality rates after hospitalization between 2008 and 2014. These findings suggest that financial incentives to improve hospitals’ readmission performance have not increased mortality after hospitalization.

Introduction: Despite a dramatic increase in the incidence of acute myocardial infarction (AMI) in China, little is known about patient’s health status in the year following discharge. We studied the change in angina frequency and angina-related quality of life at 1 year after AMI among Chinese patients. Methods: Among 3,336 patients admitted for AMI to 53 hospitals from December 2012 to May 2014 in the China PEACE Prospective Study of Acute Myocardial Infarction, Angina frequency and angina-related quality of life were assessed with the Seattle Angina Questionnaire (SAQ) at the time of hospitalization and 1 year later. Scores ranged from 0 to 100 points, with higher scores indicating fewer symptoms and better quality of life. We categorized both 1-year scores and changes in scores to support clinical interpretability. We considered a clinically poor outcome at 1 year to be an angina frequency score ≤ 60 (daily/weekly angina) or quality of life score ≤ 50 (poor/fair quality of life). A 1-year change in score ≥ 5 was improvement, a change between -5 and 5 was interpreted as no change, and ≤ -5 was interpreted as being significantly worse at 1 year than before the AMI. Results: Participants’ average age was 60.6 years (±11.9) and 22.8% were women. The response rate was about 75% and non-responders had similar characteristics compared with responders. At baseline, the mean scores were 86.3±21.9 for angina frequency and 66.7±24.0 for quality of life, with 16.3% having daily/weekly angina and 38.8% poor quality of life. One year later, 36.3% of patients had had a clinically important improvement in angina, 49.0% had no change, and 14.7% had worse symptoms. Similarly, 52.7% experienced a clinically important improvement in quality of life, 18.2% had no change, and 29.1% had worse quality of life. At 1 year after AMI, 5.5% of patients still had severe angina symptoms and 20.9% had poor quality of life. Conclusion: There is substantial variability in Chinese patients’ symptom and quality of life recovery after AMI and more work is needed to understand the causes of this variability and how best to improve symptoms and quality of life after AMI in China.

Background— Contemporary patterns of use and outcomes of implantable cardioverter-defibrillators (ICDs) in community practice settings are not well characterized. We assessed temporal trends in patient characteristics and outcomes among older patients undergoing primary prevention ICD therapy in US hospitals between 2006 and 2010. Methods and Results— Using the National Cardiovascular Data Registry’s ICD Registry, we identified Medicare fee-for-service beneficiaries aged ≥65 years and older with left ventricular ejection fraction ≤35% who underwent primary prevention ICD implantation, including those receiving concomitant cardiac resynchronization therapy between 2006 and 2010 and could be matched to Medicare claims. Outcomes were mortality and hospitalization (all-cause and heart failure) at 180 days, and device-related complications. We used multivariable hierarchical logistic regression to assess temporal trends in outcomes accounting for changes in patient, physician, and hospital characteristics. The cohort included 117 100 patients. Between 2006 and 2010, only modest changes in patient characteristics were noted. Fewer single lead devices and more cardiac resynchronization therapy devices were used over time. Between 2006 and 2010, there were significant improvements in all outcomes, including 6-month all cause mortality (7.1% in 2006, 6.5% 2010; adjusted odds ratio, 0.88; 95% confidence interval, 0.82–0.95), 6-month rehospitalization (36.3% in 2006, 33.7% in 2010; adjusted odds ratio, 0.87; 95% confidence interval, 0.83–0.91), and device-related complications (5.8% in 2006, 4.8% in 2010; adjusted odds ratio, 0.80; 95% confidence interval, 0.74–0.88). Conclusions— The clinical characteristics of this national population of Medicare patients undergoing primary prevention ICD implantation were stable between 2006 and 2010. Simultaneous improvements in outcomes suggest meaningful advances in the care for this patient population.

Background Defibrillation testing is often performed to establish effective arrhythmia termination, but predictors and consequences of an inadequate defibrillation safety margin (DSM) remain largely unknown.

Older women experience higher complication rates and mortality after percutaneous coronary intervention (PCI) than men, but there is limited evidence about sex-based differences in outcomes among younger patients. We compared rates of complications and inhospital mortality by sex for younger and older PCI patients.A total of 1,079,751 hospital admissions for PCI were identified in the CathPCI Registry(®) from 2005 to 2008. Complication rates (general, bleeding, bleeding with transfusion, and vascular) and inhospital mortality after PCI were compared by sex and age (55 and ≥55 years). Analyses were adjusted for demographic and clinical factors and stratified by PCI type (elective, urgent, or emergency).Overall, 6% of patients experienced complications, and 1% died inhospital. Unadjusted complication rates were higher for women compared with men in both age groups. In risk-adjusted analyses, younger women (odds ratio 1.24, 95% CI 1.16-1.33) and older women (1.27, 1.09-1.47) were more likely to experience any complication than similarly aged men. The increased risk persisted across complication categories and PCI type. Within age groups, risk-adjusted mortality was marginally higher for young women (1.19, 1.00-1.41), but not for older women (1.03, 0.97-1.10). In analyses stratified by PCI type, young women had twice the mortality risk after an elective procedure as young men (2.04, 1.15-3.61).Women, regardless of age, experience more complications after PCI than men; young women are at increased mortality risk after an elective PCI. Identifying strategies to reduce adverse outcomes, particularly for women younger than 55 years, is important.

Patients with implantable cardioverter defibrillators (ICDs) can require antiarrhythmic drugs to manage arrhythmias and prevent device shocks. We sought to determine the prevalence, clinical correlates, and institutional variation in the use of antiarrhythmic drugs over time after ICD implantation. From the ICD Registry (2006 to 2011), we analyzed the trends in the use of antiarrhythmic agents prescribed at hospital discharge for patients undergoing first-time ICD placement. The patient, provider, and facility level variables associated with antiarrhythmic use were determined using multivariate logistic regression models. A median odds ratio was calculated to assess the hospital-level variation in the use of antiarrhythmic drugs. Of the cohort (n = 500,995), 15% had received an antiarrhythmic drug at discharge. The use of class III agents increased modestly (13.9% to 14.9%, p0.01). Amiodarone was the most commonly prescribed drug (82%) followed by sotalol (10%). Among the subgroups, the greatest increase in prescribing was for patients who had received a secondary prevention ICD (26% in 2006% and 30% in 2011, p0.01) or with a history of ventricular tachycardia (23% to 27%, p0.01). The median odds ratio for antiarrhythmic prescription was 1.45, indicating that 2 randomly selected hospitals would have had a 45% difference in the odds of treating identical patients with an antiarrhythmic drug. In conclusion, antiarrhythmic drug use, particularly class III antiarrhythmic drugs, is common among ICD recipients at hospital discharge and varies by hospital, suggesting an influence from local treatment patterns. The observed hospital variation suggests a role for augmentation of clinical guidelines regarding the use of antiarrhythmic drugs for patients undergoing implantation of an ICD.

We sought to evaluate concerns about US hospitals gaming readmission measures by deferring admissions for AMI and HF during the 30-day period to avoid readmission penalties. For 2011-2017, we calculated each hospital's daily rates of readmission from post-discharge day 1 to 60 for elderly Medicare

The optimal duration of dual antiplatelet therapy following percutaneous coronary intervention (PCI) in patients on oral anticoagulation (OAC) is controversial and requires consideration of ischemic and bleeding risk. Prescribing patterns for P2Y12 inhibitors in these patients have not been