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Background Prior studies have suggested that women have better outcomes than men after cardiac resynchronization therapy-defibrillator (CRT-D) implantation. Objectives The purpose of this study was to compare mortality after CRT-D implantation by sex, QRS morphology, and duration. Methods Survival curves and covariate adjusted hazard ratios (HR) were used to assess mortality by sex in 31,892 CRT-D patients in the National Cardiovascular Data Registry (NCDR), implantable cardioverter defibrillator (ICD) registry between 2006 and 2009, with up to 5 years’ follow-up (median 2.9 years, interquartile range: 2.0 to 3.9 years). Patients were grouped by QRS morphology and 10-ms increments in QRS duration. Results Among patients with left bundle branch block (LBBB), women had a 21% lower mortality risk than men (HR: 0.79; 95% CI: 0.74 to 0.84; p < 0.001); however, there was no sex difference in non-LBBB (HR: 0.95; 95% CI: 0.85 to 1.06; p = 0.37). Longer QRS duration was associated with better survival in both sexes with LBBB, but not in patients without LBBB. Compared with women with LBBB and QRS of 120 to 129 ms, women with LBBB and QRS of 140 to 149 ms had a 27% lower mortality (HR: 0.73; 95% CI: 0.60 to 0.88; p = 0.001); this difference was 18% in men (HR: 0.82; 95% CI: 0.71 to 0.93; p = 0.003). Mortality in LBBB and QRS of 150 ms or longer compared with those with LBBB and QRS of 120 to 129 ms was similar between sexes (HR: 0.61 to 0.68; p < 0.001 for women and HR: 0.58 to 0.66; p < 0.001 for men). Sex interactions within 10-ms groups were not significant. Conclusions Among patients with LBBB who received CRT-D, mortality is lower in women than men. Additionally, longer QRS duration in LBBB is associated with better survival in both sexes. In contrast, there is no sex difference in patients without LBBB, regardless of QRS duration. Further studies should include a non-CRT comparator group to confirm these findings. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this study was to report on the all-cause readmission and repeat revascularization rates after percutaneous coronary intervention (PCI). Background: Although PCIs are frequently performed, 30-day rates of readmission and repeat revascularization after PCI are not known. Methods: Retrospective analysis of a cohort of Medicare fee-for-service admissions associated with a PCI in 2005. Primary outcomes were 30-day all-cause readmission rates and 30-day readmission rates associated with a revascularization procedure. Results: A total of 315,241 PCI procedures performed at 1,108 hospitals were included in the analysis. The all-cause 30-day readmission rate was 14.6%, and the all-cause 30-day mortality rate was 1.0%. All-cause 30-day mortality among readmitted patients was higher than patients who were not readmitted (3.6% vs. 0.6%; p < 0.001). The 30-day readmission rate of acute myocardial infarction (AMI) patients was significantly higher than that of non-AMI patients (AMI 17.5%, non-AMI 13.6%, p < 0.001). Among all patients readmitted within 30 days after the index PCI, 27.5% had an associated revascularization procedure (PCI 25.8%, coronary artery bypass grafting 1.7%). The median readmission rates varied across hospitals, from 8.9% in the lowest decile to 22.0% in the highest decile. Conclusions: A substantial proportion of PCI patients are readmitted within 30 days of discharge, and readmission rates vary widely across hospitals. Readmissions within 30 days of an index PCI procedure were associated with a significantly higher 30-day mortality rate, and more than one-quarter of such readmissions resulted in a repeat revascularization procedure. These findings warrant further attention to determine whether these readmissions are preventable. [Copyright &y& Elsevier]

Objectives: The aim of this study was to determine the use of pre-hospital electrocardiogram (ECG) in patients with ST-segment elevation myocardial infarction (STEMI) undergoing reperfusion therapy, and evaluate the effect of pre-hospital ECG on door-to-reperfusion times. Background: Although national guidelines recommend the use of pre-hospital ECG, there is limited contemporary information about its current use and effectiveness. Methods: Using data from the National Registry of Myocardial Infarction-4, we studied patients with STEMI or left bundle branch block who received acute reperfusion with either fibrinolytic therapy (n = 35,370) or primary percutaneous coronary intervention (PCI) (n = 21,277) within 6 h of admission. We determined the prevalence of pre-hospital ECG use, evaluated the association between pre-hospital ECG and door-to-reperfusion time, and estimated the incremental reduction in time to reperfusion using hierarchical models to adjust for differences in patient and hospital characteristics. Results: A pre-hospital ECG was performed in 4.5% of the fibrinolytic therapy cohort and in 8.0% of the PCI cohort. After adjusting for patient and hospital characteristics, the use of pre-hospital ECG was associated with a significantly shorter geometric mean door-to-drug time: 24.6 min (95% confidence interval [CI]: 23.7 to 25.5) vs. 34.7 min (95% CI: 34.2 to 35.3; p < 0.0001), and a significantly shorter geometric mean door-to-balloon time (94.0 min [95% CI: 91.8 to 96.3] vs. 110.3 min [95% CI: 108.7 to 112.0]; p < 0.0001). Conclusions: The national use of pre-hospital ECG to diagnose and facilitate the treatment of STEMI remains low. When used, however, pre-hospital ECG is associated with a significantly shorter time to reperfusion. [Copyright &y& Elsevier]

: ObjectivesThe aim of this study was to assess the prognostic importance of left ventricular ejection fraction (LVEF) in stable outpatients with heart failure (HF).: BackgroundAlthough LVEF is an accepted prognostic indicator of prognosis in HF patients, the relationship of LVEF and mortality across the full spectrum of LVEF is incompletely understood.: MethodsWe examined the association of LVEF and outcomes among 7,788 stable HF patients enrolled in the Digitalis Investigation Group trial.: ResultsDuring mean follow-up of 37 months, mortality was substantial in all LVEF groups (range, LVEF ≤ 15%, 51.7%, LVEF > 55%, 23.5%). Among patients with LVEF ≤ 45%, mortality decreased in a near linear fashion across successively higher LVEF groups (LVEF < 15%, 51.7%; LVEF 36% to 45%, 25.6%; p < 0.0001). This association was present after multivariable adjustment, although the magnitude of this associated risk was reduced (LVEF ≤ 15%: hazard ratio [HR] 1.77, 95% confidence interval [CI] 1.48 to 2.11; LVEF 16% to 25%: HR 1.44, 95% CI 1.28 to 1.61; LVEF 26% to 35%: HR 1.10, 95% CI 0.98 to 1.28; LVEF 36% to 45%: referent). In contrast, mortality rates were comparable among patients with LVEF > 45% both before (LVEF 46% to 55%: 23.3%; LVEF > 55%: 23.5%; p = 0.25), and after multivariable adjustment (LVEF 46% to 55%: HR 0.92, 95% CI 0.77 to 1.10; LVEF > 55%: HR 0.88, 95% CI 0.71 to 1.09; LVEF 36% to 45%: referent). Patients with lower LVEF were at increased absolute risk of death due to arrhythmia and worsening HF, but these were leading causes of death in all LVEF groups.: ConclusionsAmong HF patients in sinus rhythm, higher LVEFs were associated with a linear decrease in mortality up to an LVEF of 45%. However, increases above 45% were not associated with further reductions in mortality. [Copyright &y& Elsevier]

Background: The benefits of cardiac resynchronization therapy (CRT) in patients with non-left bundle branch block (LBBB) conduction abnormality have not been fully explored.Objectives: This study sought to evaluate clinical outcomes among Medicare-aged patients with nonspecific intraventricular conduction delay (NICD) versus right bundle branch block (RBBB) in patients eligible for implantation with a CRT with defibrillator (CRT-D).Methods: Using the National Cardiovascular Data Registry implantable cardioverter-defibrillator (ICD) registry data between 2010 and 2013, the authors compared outcomes in CRT-eligible patients implanted with CRT-D versus ICD-only therapy among patients with NICD and RBBB. Also, among all CRT-D-implanted patients, the authors compared outcomes in those with NICD versus RBBB. Survival curves and multivariable adjusted hazard ratios (HRs) were used to assess outcomes including hospitalization and death.Results: In 11,505 non-LBBB CRT-eligible patients, after multivariable adjustment, among patients with RBBB, CRT-D was not associated with better outcomes, compared with ICD alone, regardless of QRS duration. Among patients with NICD and a QRS ≥150 ms, CRT-D was associated with decreased mortality at 3 years compared with ICD alone (HR: 0.602; 95% confidence interval [CI]: 0.416 to 0.871; p = 0.0071). Among 5,954 CRT-D-implanted patients, after multivariable adjustment NICD compared with RBBB was associated with lower mortality at 3 years in those with a QRS duration of ≥150 ms (HR: 0.757; 95% CI: 0.625 to 0.917; p = 0.0044).Conclusions: Among non-LBBB CRT-D-eligible patients, CRT-D implantation was associated with better outcomes compared with ICD alone specifically in NICD patients with a QRS duration of ≥150 ms. Careful patient selection should be considered for CRT-D implantation in patients with non-LBBB conduction. [ABSTRACT FROM AUTHOR]

Background: Patients with moderate-to-severe chronic kidney disease (CKD) are poorly represented in clinical trials of cardiac resynchronization therapy (CRT).Objectives: This study sought to assess the real-world comparative effectiveness of CRT with defibrillator (CRT-D) versus implantable cardioverter-defibrillator (ICD) alone in CRT-eligible patients with moderate-to-severe CKD.Methods: We conducted an inverse probability-weighted analysis of 10,946 CRT-eligible patients (ejection fraction <35%, QRS >120 ms, New York Heart Association functional class III/IV) with stage 3 to 5 CKD in the National Cardiovascular Data Registry (NCDR) ICD Registry, comparing outcomes between patients who received CRT-D (n = 9,525) versus ICD only (n = 1,421). Outcomes were obtained via Medicare claims and censored at 3 years. The primary endpoint of heart failure (HF) hospitalization or death and the secondary endpoint of death were assessed with Cox proportional hazards models. HF hospitalization, device explant, and progression to end-stage renal disease were assessed using Fine-Gray models.Results: After risk adjustment, CRT-D use was associated with a reduction in HF hospitalization or death (hazard ratio [HR]: 0.84; 95% confidence interval [CI]: 0.78 to 0.91; p < 0.0001), death (HR: 0.85; 95% CI: 0.77 to 0.93; p < 0.0004), and HF hospitalization alone (subdistribution HR: 0.84; 95% CI: 0.76 to 0.93; p < 0.009). Subgroup analyses suggested that CRT was associated with a reduced risk of HF hospitalization and death across CKD classes. The incidence of in-hospital, short-term, and mid-term device-related complications did not vary across CKD stages.Conclusions: In a nationally representative population of HF and CRT-eligible patients, use of CRT-D was associated with a significantly lower risk of the composite endpoint of HF hospitalization or death among patients with moderate-to-severe CKD in the setting of acceptable complication rates. [ABSTRACT FROM AUTHOR]

Background: Pivotal trials of percutaneous left atrial appendage occlusion (LAAO) used specific postprocedure treatment protocols.Objectives: 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.Methods: 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.Results: 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.Conclusions: 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. [ABSTRACT FROM AUTHOR]

Background: The subcutaneous (S-) implantable cardioverter-defibrillator (ICD) is an alternative to the transvenous (TV-) ICD that is increasingly implanted in younger patients; data on the safety and effectiveness of the S-ICD in older patients are lacking.Objectives: The purpose of this study was to compare outcomes among older patients who received an S- or TV-ICD.Methods: The authors compared S-ICD and single-chamber TV-ICD implants in Fee-For-Service Medicare beneficiaries using the National Cardiovascular Data Registry ICD Registry. Outcomes were ascertained from Medicare claims data. Cox regression or competing-risk models (with TV-ICD as reference) with overlap weights were used to compare death and nonfatal outcomes (device reoperation, device removal for infection, device reoperation without infection, and cardiovascular admission), respectively. Recurrent all-cause readmissions were compared using Anderson-Gill models.Results: A total of 16,063 patients were studied (age 72.6 ± 5.9 years, 28.4% women, ejection fraction 28.3 ± 8.9%). Compared with TV-ICD patients (n = 15,072), S-ICD patients (n = 991, 6.2% overall) were more often Black, younger, and dialysis dependent and less likely to have history of atrial fibrillation or flutter. In adjusted analyses, there were no differences between device type and risk of all-cause mortality (HR: 1.020; 95% CI: 0.819-1.270), device reoperation (subdistribution [s] HR: 0.976; 95% CI: 0.645-1.479), device removal for infection (sHR: 0.614; 95% CI: 0.138-2.736), device reoperation without infection (sHR: 0.975; 95% CI: 0.632-1.506), cardiovascular readmission (sHR: 1.087; 95% CI: 0.912-1.295), or recurrent all-cause readmission (HR: 1.072; 95% CI: 0.990-1.161).Conclusions: In a large representative national cohort of older patients undergoing ICD implantation, risk of death, device reoperation, device removal for infection, device reoperation without infection, and cardiovascular and all-cause readmission were similar among S- and TV-ICD recipients. [ABSTRACT FROM AUTHOR]

Objectives: We sought to describe the incidence of acute lead dislodgements and the consequences of these events in patients enrolled in the National Cardiovascular Data Registry (NCDR) Implantable Cardioverter-Defibrillator (ICD) Registry. Background: Lead dislodgements are common adverse events in patients undergoing ICD implants. Little is known regarding who is at risk and the consequences of these events. Methods: Patients enrolled between April 2006 and September 2008 were included. Acute lead dislodgement was defined as movement of the lead requiring another procedure for repositioning before discharge. Results: Acute dislodgement occurred in 2,628 of 226,764 patients. Univariate variables associated with dislodgements included older age, female sex, and patients with atrial fibrillation, chronic lung disease, cerebrovascular disease, nonischemic cardiomyopathy, and lower ejection fractions (all p < 0.002). After multivariate adjustment, factors associated with an increased risk for dislodgement included New York Heart Association functional class IV heart failure, atrial fibrillation/flutter, having a cardiac resynchronization therapy-defibrillator device, and procedures performed by physicians trained under alternative pathways. A teaching/training hospital setting was not a factor (p = 0.64). Acute dislodgements had increased odds for other adverse events including cardiac arrest, cardiac tamponade, device infection, pneumothorax, and in-hospital death even after adjustment for potential confounders (all p < 0.0001). Conclusions: Acute lead dislodgements occur more often in patients with more comorbidities and in patients undergoing implants by nonelectrophysiology-trained implanters. These events were strongly associated with increased odds for in-hospital death. [Copyright &y& Elsevier]

Objectives: We sought to examine the relationship between hospital implantable cardioverter-defibrillator (ICD) implantation volume and procedural complications in a contemporary, representative population. Background: Hospitals that perform higher volumes of procedures generally have better clinical outcomes. Methods: We examined initial ICD implantations between January 2006 and December 2008 at hospitals participating in the NCDR (National Cardiovascular Data Registry) ICD Registry and evaluated the relationship between hospital annual implant volume and in-hospital adverse outcomes. Results: The rate of adverse events declined progressively with increasing procedure volume (p trend < 0.0001). This relationship remained significant (p trend < 0.0001) after adjustment for patient clinical characteristics, operator characteristics, and hospital characteristics. The volume–outcome relationship was evident for all ICD subtypes, including single-chamber (p trend = 0.004), dual-chamber (p trend < 0.0001), and biventricular ICDs (p trend = 0.02). Conclusions: Patients who have an ICD implanted at a high-volume hospital are less likely to have an adverse event associated with the procedure than patients who have an ICD implanted at a low-volume hospital. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of the study was to define the extent and nature of cardiac resynchronization therapy (CRT) device usage outside consensus guidelines using national data. Background: Recent literature has shown that the application of CRT in clinical practice frequently does not adhere to evidence-based consensus guidelines. Factors underlying these practices have not been fully explored. Methods: From the National Cardiovascular Data Registry''s Implantable Cardiac-Defibrillator Registry, we defined a cohort of 45,392 cardiac resynchronization therapy-defibrillator (CRT-D) implants between January 2006 and June 2008 with a primary prevention indication. We defined “off-label” implants as those in which the ejection fraction was >35%, the New York Heart Association functional class was below III, or the QRS interval duration was <120 ms in the absence of a documented need for ventricular pacing. The relationships between patient, implanting physician, and hospital characteristics with off-label use were explored with multivariable hierarchical logistic regression models. Results: Overall, 23.7% of devices were placed without meeting all 3 implant criteria, most often due to New York Heart Association functional class below III (13.1% of implants) or QRS interval duration <120 ms (12.0%). Atrial fibrillation/flutter, previous percutaneous coronary intervention, and the performance of an electrophysiology study before implant were independently associated with increased odds of off-label use, whereas diabetes mellitus, increasing age, and female sex were associated with decreased odds. Physician training and insurance payer were weakly associated with the likelihood of off-label use. Conclusions: Nearly 1 in 4 patients receiving CRT devices in the study time frame did not meet guideline-based indications. Given the evolving evidence base supporting the use of CRT, these practices require careful scrutiny. [Copyright &y& Elsevier]

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. [ABSTRACT FROM AUTHOR]

Background: Left atrial appendage occlusion (LAAO) to prevent stroke in patients with atrial fibrillation has been evaluated in 2 randomized trials; post-approval clinical data are limited.Objectives: The purpose of this study was to describe the National Cardiovascular Data Registry (NCDR) LAAO Registry and present patient, hospital, and physician characteristics and in-hospital adverse event rates for Watchman procedures in the United States during its first 3 years.Methods: The authors describe the LAAO Registry structure and governance, the outcome adjudication processes, and the data quality and collection processes. They characterize the patient population, performing hospitals, and in-hospital adverse event rates.Results: A total of 38,158 procedures from 495 hospitals performed by 1,318 physicians in the United States were included between January 2016 and December 2018. The mean patient age was 76.1 ± 8.1 years, the mean CHA2DS2-VASc (congestive heart failure, hypertension, 65 years of age and older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, 65 to 74 years of age, female) score was 4.6 ± 1.5, and the mean HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score was 3.0 ± 1.1. The median annual number of LAAO procedures performed for hospitals was 30 (interquartile range: 18 to 44) and for physicians was 12 (interquartile range: 8 to 20). Procedures were canceled or aborted in 7% of cases; among cases in which a device was deployed, 98.1% were implanted with <5-mm leak. Major in-hospital adverse events occurred in 2.16% of patients; the most common complications were pericardial effusion requiring intervention (1.39%) and major bleeding (1.25%), whereas stroke (0.17%) and death (0.19%) were rare.Conclusions: The LAAO Registry has enrolled >38,000 patients implanted with the device. Patients were generally older with more comorbidities than those enrolled in the pivotal trials; however, major in-hospital adverse event rates were lower than reported in those trials. [ABSTRACT FROM AUTHOR]

Background: Recent clinical trials highlight the need for better models to identify patients at higher risk of sudden death.Objectives: The authors hypothesized that the Seattle Heart Failure Model (SHFM) for overall survival and the Seattle Proportional Risk Model (SPRM) for proportional risk of sudden death, including death from ventricular arrhythmias, would predict the survival benefit with an implantable cardioverter-defibrillator (ICD).Methods: Patients with primary prevention ICDs from the National Cardiovascular Data Registry (NCDR) were compared with control patients with heart failure (HF) without ICDs with respect to 5-year survival using multivariable Cox proportional hazards regression.Results: Among 98,846 patients with HF (87,914 with ICDs and 10,932 without ICDs), the SHFM was strongly associated with all-cause mortality (p < 0.0001). The ICD-SPRM interaction was significant (p < 0.0001), such that SPRM quintile 5 patients had approximately twice the reduction in mortality with the ICD versus SPRM quintile 1 patients (adjusted hazard ratios [HR]: 0.602; 95% confidence interval [CI]: 0.537 to 0.675 vs. 0.793; 95% CI: 0.736 to 0.855, respectively). Among patients with SHFM-predicted annual mortality ≤5.7%, those with a SPRM-predicted risk of sudden death below the median had no reduction in mortality with the ICD (adjusted ICD HR: 0.921; 95% CI: 0.787 to 1.08; p = 0.31), whereas those with SPRM above the median derived the greatest benefit (adjusted HR: 0.599; 95% CI: 0.530 to 0.677; p < 0.0001).Conclusions: The SHFM predicted all-cause mortality in a large cohort with and without ICDs, and the SPRM discriminated and calibrated the potential ICD benefit. Together, the models identified patients less likely to derive a survival benefit from primary prevention ICDs. [ABSTRACT FROM AUTHOR]

Cardiovascular disease is a leading cause of death and disability in the United States. National programs, such as the National Cardiovascular Data Registry, facilitate assessments of the quality of care and outcomes for broad populations of patients with cardiovascular disease. This report provides data for 2014 from 4 National Cardiovascular Data Registry hospital quality programs: 1) CathPCI (Diagnostic Catheterization and Percutaneous Coronary Intervention) for coronary angiography and percutaneous coronary intervention (667,424 procedures performed in 1,612 hospitals); 2) ICD Registry for implantable cardioverter-defibrillators (158,649 procedures performed in 1,715 hospitals); 3) ACTION–GWTG (Acute Coronary Treatment and Intervention Outcomes Network–Get With The Guidelines) for acute coronary syndromes (182,903 patients admitted to 907 hospitals); and 4) IMPACT (Improving Pediatric and Adult Congenital Treatment) for cardiac catheterization and intervention for pediatric and adult congenital heart disease (20,169 procedures in 76 hospitals). The report provides perspectives on the demographic and clinical characteristics of enrolled patients, characteristics of participating centers, and selected measures of processes and outcomes of care in these programs. [ABSTRACT FROM AUTHOR]

Background In appropriately selected patients with severe carotid stenosis, carotid revascularization reduces ischemic stroke. Prior clinical research has focused on the efficacy and safety of carotid revascularization, but few investigators have considered readmission as a clinically important outcome. Objectives The aims of this study were to examine frequency, timing, and diagnoses of 30-day readmission following carotid revascularization; to assess differences in 30-day readmission between patients undergoing carotid endarterectomy (CEA) and carotid artery stenting (CAS); to describe hospital variation in risk-standardized readmission rates (RSRR); and to examine whether hospital variation in the choice of procedure (CEA vs. CAS) is associated with differences in RSRRs. Methods We used Medicare fee-for-service administrative claims data to identify acute care hospitalizations for CEA and CAS from 2009 to 2011. We calculated crude 30-day all-cause hospital readmissions following carotid revascularization. To assess differences in readmission after CAS compared with CEA, we used Kaplan-Meier survival curves and fitted mixed-effects logistic regression. We estimated hospital RSRRs using hierarchical generalized logistic regression. We stratified hospitals into 5 groups by their proportional CAS use and compared hospital group median RSRRs. Results Of 180,059 revascularizations from 2,287 hospitals, CEA and CAS were performed in 81.5% and 18.5% of cases, respectively. The unadjusted 30-day readmission rate following carotid revascularization was 9.6%. Readmission risk after CAS was greater than that after CEA. There was modest hospital-level variation in 30-day RSRRs (median: 9.5%; range 7.5% to 12.5%). Variation in proportional use of CAS was not associated with differences in hospital RSRR (range of median RSRR across hospital groups 9.49% to 9.55%; p = 0.771). Conclusions Almost 10% of Medicare patients undergoing carotid revascularization were readmitted within 30 days of discharge. Compared with CEA, CAS was associated with a greater readmission risk. However, hospitals' RSRR did not differ by their proportional CAS use. [ABSTRACT FROM AUTHOR]

Background Few recent studies have compared the outcomes of coronary artery bypass graft (CABG) surgery with percutaneous coronary interventions (PCIs) in patients with isolated (single vessel) proximal left anterior descending (PLAD) coronary artery disease in the era of drug-eluting stents (DES). Objectives The goal of this study was to compare outcomes in patients with PLAD who underwent CABG and PCI with DES. Methods New York’s Percutaneous Coronary Interventions Reporting System was used to identify and track all patients who underwent CABG surgery and received DES for isolated PLAD disease between January 1, 2008 and December 31, 2010, and who were followed-up through December 31, 2011. A total of 5,340 of 6,064 (88%) patients received DES. Patients were matched to vital statistics data to obtain mortality after discharge and matched to New York’s administrative data to obtain readmissions for myocardial infarction (MI) and stroke. To minimize selection bias, patients were propensity matched into 715 CABG and/or DES pairs, and 3 outcome measures were compared across the pairs. Results Kaplan-Meier estimates for CABG and DES did not significantly differ for mortality or mortality, MI, and/or stroke, but repeat revascularization rates were lower for CABG (7.09% vs. 12.98%; p = 0.0007). After further adjustment with Cox proportional hazards models, there were still no significant differences in 3-year mortality rates (CABG and/or DES adjusted hazard ratio (AHR): 1.14; 95% confidence interval [CI]: 0.70 to 1.85) or mortality, MI, and/or stroke rates (AHR: 1.15; 95% CI: 0.76 to 1.73), and the repeat revascularization rate remained significantly lower for CABG patients (AHR: 0.54; 95% CI: 0.36 to 0.81). Conclusions Despite the higher rating in current guidelines of CABG (Class IIa vs. Class IIb) for patients with isolated PLAD disease, there were no differences in mortality or mortality, MI, and/or stroke, although CABG patients had significantly lower repeat revascularization rates. [ABSTRACT FROM AUTHOR]

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. Objectives The aims of this study were to develop a simple risk score predictive of an inadequate DSM at implantable cardioverter-defibrillator (ICD) implantation and to examine the association of an inadequate DSM with adverse events. Methods A total of 132,477 ICD Registry implantations between 2010 and 2012 were analyzed. Using logistic regression models, factors most predictive of an inadequate DSM (defined as the lowest successful energy tested <10 J from maximal device output) were identified, and the association of an inadequate DSM with adverse events was evaluated. Results Inadequate DSMs occurred in 12,397 patients (9.4%). A simple risk score composed of 8 easily identifiable variables characterized patients at high and low risk for an inadequate DSM, including (with assigned points) age <70 years (1 point); male sex (1 point); race: black (4 points), Hispanic (2 points), or other (1 point); New York Heart Association functional class III (1 point) or IV (3 points); no ischemic heart disease (2 points); renal dialysis (3 points); secondary prevention indication (1 point); and ICD type: single-chamber (2 points) or biventricular (1 point) device. An inadequate DSM was associated with greater odds of complications (odds ratio: 1.22; 95% confidence interval: 1.09 to 1.37; p = 0.0006), hospital stay >3 days (odds ratio: 1.24; 95% confidence interval: 1.19 to 1.30; p < 0.0001), and in-hospital mortality (odds ratio: 1.96; 95% confidence interval: 1.63 to 2.36; p < 0.0001). Conclusions A simple risk score identified ICD recipients at risk for an inadequate DSM. An inadequate DSM was associated with an increased risk for in-hospital adverse events. [ABSTRACT FROM AUTHOR]

Objectives: To better inform patients and physicians of the expected risk of adverse events and to assist hospitals' efforts to improve the outcomes of patients undergoing implantable cardioverter-defibrillator (ICD) implantation, we developed and validated a risk model using data from the NCDR (National Cardiovascular Data Registry) ICD Registry. Background: ICD prolong life in selected patients, but ICD implantation carries the risk of periprocedural complications. Methods: We analyzed data from 240,632 ICD implantation procedures between April 1, 2010, and December 31, 2011 in the registry. The study group was divided into a derivation (70%) and a validation (30%) cohort. Multivariable logistic regression was used to identify factors associated with in-hospital adverse events (complications or mortality). A parsimonious risk score was developed on the basis of beta estimates derived from the logistic model. Hierarchical models were then used to calculate risk-standardized complication rates to account for differences in case mix and procedural volume. Results: Overall, 4,388 patients (1.8%) experienced at least 1 in-hospital complication or death. Thirteen factors were independently associated with an increased risk of adverse outcomes. Model performance was similar in the derivation and validation cohorts (C-statistics = 0.724 and 0.719, respectively). The risk score characterized patients into low- and-high risk subgroups for adverse events (≤10 points, 0.3%; ≥30 points, 4.2%). The risk-standardized complication rates varied significantly across hospitals (median: 1.77, interquartile range 1.54, 2.14, 5th/95th percentiles: 1.16/3.15). Conclusions: We developed a simple model that predicts risk for in-hospital adverse events among patients undergoing ICD placement. This can be used for shared decision making and to benchmark hospital performance. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this report was to characterize the patients, participating centers, and measures of quality of care and outcomes for 5 NCDR (National Cardiovascular Data Registry) programs: 1) ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry–GWTG (Get With The Guidelines) for acute coronary syndromes; 2) CathPCI Registry for coronary angiography and percutaneous coronary intervention; 3) CARE (Carotid Artery Revascularization and Endarterectomy) Registry for carotid revascularization; 4) ICD Registry for implantable cardioverter defibrillators; and the 5) PINNACLE (Practice INNovation And CLinical Excellence) Registry for outpatients with cardiovascular disease (CVD). Background: CVD is a leading cause of death and disability in the United States. The quality of care for patients with CVD is suboptimal. National registry programs, such as NCDR, permit assessments of the quality of care and outcomes for broad populations of patients with CVD. Methods: For the year 2011, we assessed for each of the 5 NCDR programs: 1) demographic and clinical characteristics of enrolled patients; 2) key characteristics of participating centers; 3) measures of processes of care; and 4) patient outcomes. For selected variables, we assessed trends over time. Results: In 2011 ACTION Registry–GWTG enrolled 119,967 patients in 567 hospitals; CathPCI enrolled 632,557 patients in 1,337 hospitals; CARE enrolled 4,934 patients in 130 hospitals; ICD enrolled 139,991 patients in 1,435 hospitals; and PINNACLE enrolled 249,198 patients (1,436,328 individual encounters) in 74 practices (1,222 individual providers). Data on performance metrics and outcomes, in some cases risk-adjusted with validated NCDR models, are presented. Conclusions: The NCDR provides a unique opportunity to understand the characteristics of large populations of patients with CVD, the centers that provide their care, quality of care provided, and important patient outcomes. [Copyright &y& Elsevier]

Objectives: The purpose of this study was to examine use and describe outcomes of radial access for percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). Background: Transradial PCI (TRI) is associated with reduced risk of bleeding and vascular complications, as compared with femoral access PCI (FPCI). Studies have suggested that TRI may reduce mortality among patients with STEMI. Methods: We examined 294,769 patients undergoing PCI for STEMI at 1,204 hospitals in the CathPCI Registry between 2007 and 2011. Patients were grouped according to access site used for PCI. The temporal trend in the rate of radial versus femoral approach was determined. For minimization of confounding, an inverse probability weighting analysis incorporating propensity scores was used to compare procedural success, post-PCI bleeding, door-to-balloon times, and in-hospital mortality between radial and femoral access. Results: Over the 5-year period, the use of TRI versus FPCI in STEMI increased from 0.9% to 6.4% (p < 0.0001). There was no difference in procedural success. TRI was associated with longer median door-to-balloon time (78 vs. 74 min; p < 0.0001) but lower adjusted risk of bleeding (odds ratio [OR]: 0.62; 95% CI: 0.53 to 0.72; p < 0.0001) and lower adjusted risk of in-hospital mortality (OR: 0.76; 95% CI: 0.57 to 0.99; p = 0.0455). Conclusions: In this large national database, use of radial access for PCI in STEMI increased over the study period. Despite longer door-to-balloon times, the radial approach was associated with lower bleeding rate and reduced in-hospital mortality. These data provide support to execute an adequately powered randomized controlled trial comparing radial and femoral approaches for PCI in STEMI. [ABSTRACT FROM AUTHOR]

Objectives: The National Cardiovascular Data Registry (NCDR) developed the Data Quality Program to meet the objectives of ensuring the completeness, consistency, and accuracy of data submitted to the observational clinical registries. The Data Quality Program consists of 3 main components: 1) a data quality report; 2) a set of internal quality assurance protocols; and 3) a yearly data audit program. Background: Since its inception in 1997, the NCDR has been the basis for the development of performance and quality metrics, site-level quality improvement programs, and peer-reviewed health outcomes research. Methods: Before inclusion in the registry, data are filtered through the registry-specific algorithms that require predetermined levels of completeness and consistency for submitted data fields as part of the data quality report. Internal quality assurance protocols enforce data standards before reporting. Within each registry, 300 to 625 records are audited annually in 25 randomly identified sites (i.e., 12 to 25 records per audited site). Results: In the 2010 audits, the participant average raw accuracy of data abstraction for the CathPCI Registry, ICD Registry, and ACTION Registry-GWTG were, respectively, 93.1% (range, 89.4% minimum, 97.4% maximum), 91.2% (range, 83.7% minimum, 95.7% maximum), and 89.7.% (range, 85% minimum, 95% maximum). Conclusions: The 2010 audits provided evidence that many fields in the NCDR accurately represent the data from the medical charts. The American College of Cardiology Foundation is undertaking a series of initiatives aimed at creating a quality assurance rapid learning system, which, when complete, will monitor, evaluate, and improve data quality. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to assess percutaneous coronary intervention (PCI) for unprotected left main coronary artery (ULMCA) stenosis in routine U.S. clinical practice. Background: Percutaneous coronary intervention for ULMCA stenosis is controversial; however, current use and outcomes of ULMCA PCI in routine U.S. clinical practice have not been described. Methods: We evaluated 5,627 patients undergoing ULMCA PCI at 693 centers within the National Cardiovascular Data Registry Catheterization Percutaneous Coronary Intervention Registry for temporal trends in PCI use (2004 to 2008), patient characteristics, and in-hospital mortality. Thirty-month mortality and composite major adverse events (death, myocardial infarction, and revascularization) with drug-eluting versus bare-metal stents were compared using inverse probability weighted (IPW) hazard ratios (HRs) in a nonrandomized Medicare-linked (age ≥65 years) patient cohort (n = 2,765). Results: ULMCA PCI was performed in 4.3% of patients with ULMCA stenosis. Unadjusted in-hospital mortality rates ranged from 2.9% for elective cases to 45.1% for emergent/salvage cases. By 30 months, 57.9% of the elderly ULMCA PCI population experienced death, myocardial infarction, or revascularization, and 42.7% died. Patients receiving drug-eluting stents (versus bare-metal stents) had a lower 30-month mortality (IPW HR: 0.84, 95% confidence interval [CI]: 0.73 to 0.96), but the composite of major adverse events were similar (IPW HR: 0.95, 95% CI: 0.84 to 1.06). Conclusions: In the United States, ULMCA PCI is performed in <5% of patients with ULMCA disease and is generally reserved for those at high procedural risk. Adverse events are common in elderly patients and are related to patient and procedural characteristics, including stent type. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this study was to determine if enrollment in the Door-to-Balloon (D2B) Alliance, a national quality campaign sponsored by the American College of Cardiology and 38 partner organizations, was associated with increased likelihood of patients who received primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI) being treated within 90 min of hospital presentation. Background: The D2B Alliance, launched in November 2006, sought to achieve the goal of having 75% of patients with STEMI treated within 90 min of hospital presentation. Methods: We conducted a longitudinal study of D2B times in 831 hospitals participating in the National Cardiovascular Data Registry (NCDR) CathPCI Registry, April 1, 2005, to March 31, 2008. Results: By March 2008, >75% of patients had D2B times of ≤90 min, compared with only about one-half of patients with D2B times within 90 min in April 2005. Trends since the launch of the D2B Alliance showed that patients treated in hospitals enrolled in the D2B Alliance for at least 3 months were significantly more likely than patients treated in nonenrolled hospitals to have D2B times within 90 min, although the magnitude of the difference was modest (odds ratio: 1.16; 95% confidence interval: 1.07 to 1.27). Conclusions: The D2B Alliance reached its goal of 75% of patients with STEMI having D2B times within 90 min by 2008. [Copyright &y& Elsevier]

Objectives: We evaluated whether appropriateness and baseline risk of cardiac catheterization varied according to regional intensity of invasive therapy after acute myocardial infarction (AMI), and whether AMI mortality varied according to invasive intensity regions. Background: Marked regional variations exist in cardiac invasive procedure use after AMI within the U.S. Methods: We performed an analysis of 44,639 Medicare fee-for-service beneficiaries hospitalized with AMI between 1998 and 2001. Invasive procedure intensity was determined based on overall cardiac catheterization rates for Medicare enrollees. Cardiac catheterization appropriateness was determined by the American College of Cardiology/American Heart Association classification and baseline risk was estimated using the GRACE (Global Registry of Acute Coronary Events) risk score. The primary outcomes of the study were cardiac catheterization use within 60 days and 3-year mortality after hospital admission. Results: Higher invasive intensity regions were more likely to perform cardiac catheterizations on class I patients (appropriate) (RR 1.38, 95% confidence interval [CI] 1.27 to 1.48), class II patients (equivocal) (RR 1.42, 95% CI 1.31 to 1.53), and class III patients (inappropriate) (RR 1.29, 95% 0.97 to 1.67) compared with low-intensity regions after adjusting for patient and physician characteristics. The overall cardiac catheterization use was 5.2% lower for each increase in GRACE risk decile, and this relationship was observed similarly in all regions. Risk-standardized mortality rates of AMI patients at 3 years were not substantially different between regions. Conclusions: Although higher-risk patients and those with more appropriate indications may have the most to benefit from an invasive strategy after AMI, we found that higher-invasive regions do not differentiate procedure selection based on the patients’ appropriateness or their baseline risks. [Copyright &y& Elsevier]

Objectives: We sought to determine the effect of door-to-balloon time on mortality for patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Background: Studies have found conflicting results regarding this relationship. Methods: We conducted a cohort study of 29,222 STEMI patients treated with PCI within 6 h of presentation at 395 hospitals that participated in the National Registry of Myocardial Infarction (NRMI)-3 and -4 from 1999 to 2002. We used hierarchical models to evaluate the effect of door-to-balloon time on in-hospital mortality adjusted for patient characteristics in the entire cohort and in different subgroups of patients based on symptom onset-to-door time and baseline risk status. Results: Longer door-to-balloon time was associated with increased in-hospital mortality (mortality rate of 3.0%, 4.2%, 5.7%, and 7.4% for door-to-balloon times of ≤90 min, 91 to 120 min, 121 to 150 min, and >150 min, respectively; p for trend <0.01). Adjusted for patient characteristics, patients with door-to-balloon time >90 min had increased mortality (odds ratio 1.42; 95% confidence interval [CI] 1.24 to 1.62) compared with those who had door-to-balloon time ≤90 min. In subgroup analyses, increasing mortality with increasing door-to-balloon time was seen regardless of symptom onset-to-door time (≤1 h, >1 to 2 h, >2 h) and regardless of the presence or absence of high-risk factors. Conclusions: Time to primary PCI is strongly associated with mortality risk and is important regardless of time from symptom onset to presentation and regardless of baseline risk of mortality. Efforts to shorten door-to-balloon time should apply to all patients. [Copyright &y& Elsevier]

Objectives: The purpose of this study was to analyze recent trends in door-to-reperfusion time and to identify hospital characteristics associated with improved performance. Background: Rapid reperfusion improves survival for patients with acute ST-segment elevation myocardial infarction (STEMI). Methods: In this retrospective observational study from the National Registry of Myocardial Infarction (NRMI)-3 and -4, between 1999 and 2002, we analyzed door-to-needle and door-to-balloon times in patients admitted with STEMI and receiving fibrinolytic therapy (n = 68,439 patients in 1,015 hospitals) or percutaneous coronary intervention (n = 33,647 patients in 421 hospitals) within 6 h of hospital arrival. Results: In 1999, only 46% of the patients in the fibrinolytic therapy cohort were treated within the recommended 30-min door-to-needle time; only 35% of the patients in the percutaneous coronary intervention cohort were treated within the recommended 90-min door-to-balloon time. Improvement in these times to reperfusion over the four-year study period was not statistically significant (door-to-needle: −0.01 min/year, 95% confidence interval [CI] −0.24 to +0.23, p > 0.9; door-to-balloon: −0.57 min/year, 95% CI −1.24 to +0.10, p = 0.09). Only 33% (337 of 1,015) of hospitals improved door-to-needle time by more than one min/year, and 26% (110 of 421) improved door-to-balloon time by more than three min/year. No hospital characteristic was significantly associated with improvement in door-to-needle time. Only high annual percutaneous coronary intervention volume and location in New England were significantly associated with greater improvement in door-to-balloon time. Conclusions: Fewer than one-half of patients with STEMI receive reperfusion in the recommended door-to-needle or door-to-balloon time, and mean time to reperfusion has not decreased significantly in recent years. Relatively few hospitals have shown substantial improvement. [Copyright &y& Elsevier]

Prior Aspirin Use and Outcomes in Elderly Patients Hospitalized With Acute Myocardial Infarction Edward L. Portnay, JoAnne M. Foody, Saif S. Rathore, Yongfei Wang, Frederick A. Masoudi, Jeptha P. Curtis, Harlan M. Krumholz We examined the association between prior aspirin use and mortality at one month and six months in 118,992 elderly patients and prior aspirin use and readmissions in 78,975 elderly patients with myocardial infarction (MI) in a national sample. After multivariable adjustment, prior aspirin use was associated with lower risk of one-month mortality (relative risk 0.93, 95% confidence interval [CI] 0.90 to 0.96) and six-month mortality (hazard ratio 0.94, 95% CI 0.91 to 0.96). Prior aspirin use tended to reduce all-cause or coronary artery disease readmission at one month or six months. Prior aspirin use is not a marker of increased mortality in elderly patients hospitalized with MI. Objectives: We sought to assess the association between prior aspirin use and mortality, all-cause readmission, and condition-specific readmission at one month and six months in a national sample of Medicare beneficiaries hospitalized with a confirmed myocardial infarction (MI). Background: Prior aspirin use is considered a marker of higher risk in patients with MI, yet the prognostic significance of this factor has been debated. Methods: Medicare beneficiaries ≥65 years old hospitalized with MI were evaluated to determine whether there was an association between prior aspirin use and mortality (n = 118,992), all-cause readmission, and condition-specific readmission (n = 78,975) at one month and six months. Results: One-third of the patients (n = 39,531, 33.2%) were using aspirin before admission. Those with prior aspirin use had significantly lower mortality at one month (16.1% vs. 19.0%, p &#60; 0.0001) and six months (24.7% vs. 27.5%, p &#60; 0.0001). After multivariable adjustment, prior aspirin use was found to be associated with a lower risk of one-month (relative risk ratio 0.93, 95% confidence interval [CI] 0.90 to 0.96) and six-month mortality (hazard ratio 0.94, 95% CI 0.91 to 0.96). Prior aspirin use tended to reduce all-cause or coronary artery disease readmissions at one month or six months. Conclusions: Prior aspirin use is not a marker of increased mortality in patients ≥65 years old hospitalized with MI. [Copyright &y& Elsevier]

The National Cardiovascular Data Registries (NCDR) of the American College of Cardiology consists of ten national programs designed to measure quality of care for high impact cardiovascular conditions and procedures. The NCDR provides feedback with benchmarking of a broad range of quality metrics to participants; supports quality improvement interventions at the local and national level; and serves as the basis for cardiovascular health services and epidemiology research that informs contemporary clinical care. This report provides a summary of key findings from four established hospital programs: CathPCI Registry (capturing data on coronary angiography and percutaneous coronary interventions); ACTION-GWTG (acute myocardial infarction) the ICD Registry (implantable cardioverter defibrillators and cardiac resynchronization therapy); and the IMPACT Registry (catheterization procedures for congenital heart disease in children and adults). A more complete report is published separately.[Ref complete data report] Data from the ambulatory programs and those focusing on newly adopted technologies will be reported separately or will be included in future reports. The data provided reflect care in 2014 and in some cases include temporal trends since 2011. NCDR data provide a unique, clinically rich national perspective on the care and outcomes of high-impact cardiovascular conditions and procedures that are not available elsewhere. [ABSTRACT FROM AUTHOR]

Cardiovascular disease is a leading cause of death and disability in the United States. National programs, such as the National Cardiovascular Data Registry, facilitate assessments of the quality of care and outcomes for broad populations of patients with cardiovascular disease. This report provides data for 2014 from 4 National Cardiovascular Data Registry hospital quality programs: 1) CathPCI (Diagnostic Catheterization and Percutaneous Coronary Intervention) for coronary angiography and percutaneous coronary intervention (667,424 procedures performed in 1,612 hospitals); 2) ICD Registry for implantable cardioverter-defibrillators (158,649 procedures performed in 1,715 hospitals); 3) ACTION-GWTG (Acute Coronary Treatment and Intervention Outcomes Network-Get With The Guidelines) for acute coronary syndromes (182,903 patients admitted to 907 hospitals); and 4) IMPACT (Improving Pediatric and Adult Congenital Treatment) for cardiac catheterization and intervention for pediatric and adult congenital heart disease (20,169 procedures in 76 hospitals). The report provides perspectives on the demographic and clinical characteristics of enrolled patients, characteristics of participating centers, and selected measures of processes and outcomes of care in these programs. [ABSTRACT FROM AUTHOR]