BACKGROUND: The appropriate use criteria (AUCs) are a diverse group of indications aimed to better evaluate the benefits of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy.
OBJECTIVE: The purpose of this study was to quantify the proportion of ICD and cardiac resynchronization therapy with defibrillator (CRT-D) implants as appropriate, may be appropriate (MA), or rarely appropriate (RA) on the basis of the AUC guidelines.
METHODS: This is a multicenter retrospective study of patients within the National Cardiovascular Data Registry undergoing ICD implantation between April 2018 and March 2019 at >1500 US hospitals. The appropriateness of ICD implants was adjudicated using the AUC.
RESULTS: Of 309,318 ICDs, 241,438 were primary prevention implants (78.1%) and 67,880 secondary prevention implants (21.9%); 243,532 (79%) were mappable to the AUC. For primary prevention, 185,431 ICDs (96.4%) were appropriate, 5660 (2.9%) MA, and 1205 (0.6%) RA. For secondary prevention, 47,498 ICDs (92.7%) were appropriate, 2581 (5%) MA, and 1157 (2.3%) RA. A significant number of RA devices were implanted in patients with New York Heart Association class IV heart failure who were ineligible for advanced therapies (53.9%) and those with myocardial infarction within 40 days (18.1%). The appropriateness of the pacing lead was more variable, with 48,470 dual-chamber ICD implants (62%) being classified as appropriate, 29,209 (37.4%) MA, and 448 (0.6%) RA. Among CRT-D implants, 63,848 (82.2%) were appropriate, 9900 (12.7%) MA, and 3940 (5.1%) RA for left ventricular pacing. A total of 99,754 implants were deemed appropriate but excluded from Centers for Medicare & Medicaid Services National Coverage Determination. More than 92% of hospitals had an RA implant rate of <4%.
CONCLUSIONS: In this large national registry, 95% of mappable ICD and CRT-D implants were considered appropriate, with <2% of RA implants. Nearly 100,000 appropriate implants are excluded by Centers for Medicare & Medicaid Services National Coverage Determination.

The National Cardiovascular Data Registry (NCDR) AFib Ablation Registry was created to assess real-world prevalence, demographic characteristics, procedural management, and outcomes of patients undergoing atrial fibrillation (AF) ablation procedures.
The goal of this study was to characterize the patient, hospital, and physician characteristics and in-hospital outcomes related to AF ablation in the first 5 years of the registry.
This paper describes the AFib Ablation Registry structure and governance, outcome assessment processes, data quality, and data collection processes. The characteristics of the patient population, hospitals, and in-hospital outcomes are also described.
A total of 76,219 patients were included in the registry between January 2016 and December 2020 (mean age 65.5 ± 10.3 years, 65.2% male, 55.8% paroxysmal AF, mean CHA2DS2-VASc score 2.7 ± 1.6) treated by 708 physicians in 162 hospitals. Successful isolation of all pulmonary veins was achieved in 92.4% of patients. The prevalence of any complication during procedural admission was 2.50% and major complication was 0.9%, including significant bradycardia in 0.47%, heart failure in 0.47%, and pericardial effusion requiring intervention in 0.44%. Hospitalization >1 day occurred in 11.8% of patients, and in-hospital death was rare (n = 41 [0.05%]).
The NCDR AFib Ablation Registry is the largest multicenter, prospective cohort study of patients undergoing catheter ablation worldwide. Results in the first 5 years showed that successful pulmonary vein isolation is achieved in the majority of patients, with a low rate of complications. Future studies from the registry will assess practice trends, evaluate treatment patterns associated with different patient outcomes, and support development of evidence-based guidelines.

Cardiovascular registries play an integral role in providing real-world data on a number of cardiovascular conditions and allowing measurement of quality metrics across a large cohort of patients. Over the past 35 years, the number of cardiovascular registries has skyrocketed, and their use will only continue to grow as data on novel procedures and devices will need to be collected and analyzed. The American College of Cardiology and Society of Thoracic Surgeons Transcatheter Valve Therapy Registry is just one example of a modern registry that plays a crucial role in collecting data on patients undergoing transcatheter valvular procedures. Through public reporting registries, data can be shared on a hospital and provider level for many quality performance measures. There remains much work to be done on allowing automated data extraction from the electronic medical record directly into registries. No matter how sophisticated and complete a registry is, it can never overcome the problem of treatment selection bias that is inherent in observational data. This review discusses the growth, benefits, and limitations of national registries and their role in developing evidence for best clinical practice, measuring outcomes, providing feedback to clinicians, and improving quality of care.

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The benefits of cardiac resynchronization therapy (CRT) in patients with non-left bundle branch block (LBBB) conduction abnormality have not been fully explored.
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).
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.
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).
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.

Individual risk factors of intraprocedural cardiac injury (cardiac perforation and tamponade) during implantable cardioverter defibrillator (ICD) placement have been documented. However, the prognostic impact of their coexistence has not been explored.
To develop a risk score model to identify patients at risk for intraprocedural cardiac injury.
We identified 438 679 patients from National Cardiovascular Data Registry (NCDR)-ICD who underwent de novo ICD implantation between 2010 and 2015, split randomly into a derivation cohort (n = 220 000) and a validation cohort (n = 218 679). The generalized estimating equations (GEEs) analysis with quasilikelihood under the independence model criterion goodness-of-fit statistics were used to identify the predictors of intraprocedural cardiac injury and a risk scoring model was developed. Model discrimination was assessed by receiver-operator characteristic curve and C-statistic.
The risk of intraprocedural cardiac injury in the overall cohort was 0.13%. GEE analysis yielded seven variables (points in parentheses) that were strongly associated with intraprocedural cardiac injury: age, greater than 75 years (1), female gender (1), body mass index, less than 18.5 kg/m 2 (1), hypertension (1), chronic lung disease (1), left bundle branch block (1), and continued warfarin use (1). Only prior history of coronary artery bypass grafting (CABG) (-1) was associated with reduced risk. A risk scoring system was developed that had good discrimination with a C-statistic of 0.72. The risk of intraprocedural cardiac injury increased with the increase in risk score from low risk (0.03%) to high risk (1.37%).
A practical risk score model can stratify patients into high- and low-risk groups for cardiac perforation or tamponade before undergoing ICD implantation.

Assessment of clinical outcomes such as 30-day mortality following coronary revascularization procedures has historically been used to spur quality improvement programs. Public reporting of risk-adjusted outcomes is already mandated in several states, and proposals to further expand public reporting have been put forward as a means of increasing transparency and potentially incentivizing high quality care. However, for public reporting of outcomes to be considered a useful surrogate of procedural quality of care, several prerequisites must be met. First, the reporting measure must be truly representative of the quality of the procedure itself, rather than be dominated by other underlying factors, such as the overall level of illness of a patient. Second, to foster comparisons among physicians and institutions, the metric requires accurate ascertainment of and adjustment for differences in patient risk profiles. This is particularly relevant for high-risk clinical patient scenarios. Finally, the potential deleterious consequences of public reporting of a quality metric should be considered prior to expanding the use of public reporting more broadly. In this viewpoint, the authors review in particular the characterization of high-risk patients currently treated by percutaneous coronary interventional procedures, assessing the adequacy of clinical risk models used in this population. They then expand upon the limitations of 30-day mortality as a quality metric for percutaneous coronary intervention, addressing the strengths and limitations of this metric, as well as offering suggestions to enhance its future use in public reporting.

BACKGROUND: Prior studies have reported that more than 20% of implantable cardioverter-defibrillator (ICD) implantations in the United States do not adhere to trial-based criteria.
OBJECTIVE: We sought to investigate the patient characteristics associated with not meeting the inclusion criteria of the clinical trials that have demonstrated the efficacy of primary prevention ICDs.
METHODS: Using data from the National Cardiovascular Data Registry\'s ICD Registry, we identified patients who received ICDs for primary prevention from January 2006 to December 2008. We determined whether patients met the inclusion criteria of at least 1 of the 4 ICD primary prevention trials: Multicenter Automatic Defibrillator Implantation Trial (MADIT), MADIT-II, Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), and the Multicenter Unsustained Tachycardia Trial (MUSTT).
RESULTS: Among 150,264 patients, 86% met criteria for an ICD implantation based on trial data. The proportion of patients who did not meet trial-based criteria increased as age decreased. In multivariate analysis, the significant predictors for not meeting trial criteria included prior cardiac transplantation (odds ratio [OR] 2.1), pediatric electrophysiology operator (OR 2.0), and high-grade atrioventricular conduction disease (OR 1.4).
CONCLUSIONS: Among National Cardiovascular Data Registry registrants receiving first-time ICDs for primary prevention, the majority met trial-based criteria. Multivariate analyses suggested that many patients who did not meet the trial-based criteria may have had clinical circumstances that warranted ICD implantation. These findings caution against the use of trial-based indications to determine site quality metrics that could penalize sites that care for younger patients. The planned incorporation of appropriate use criteria into the ICD registry may better characterize patient- and site-level quality and performance.

OBJECTIVE: This study sought to examine the contemporary incidence, predictors and outcomes of acute kidney injury in patients undergoing percutaneous coronary interventions.
BACKGROUND: Acute kidney injury (AKI) is a serious and potentially preventable complication of percutaneous coronary interventions (PCIs) that is associated with adverse outcomes. The contemporary incidence, predictors, and outcomes of AKI are not well defined, and clarifying these can help identify high-risk patients for proactive prevention.
METHODS: A total of 985,737 consecutive patients underwent PCIs at 1,253 sites participating in the National Cardiovascular Data Registry Cath-PCI registry from June 2009 through June 2011. AKI was defined on the basis of changes in serum creatinine level in the hospital according to the Acute Kidney Injury Network (AKIN) criteria. Using multivariable regression analyses with generalized estimating equations, we identified patient characteristics associated with AKI.
RESULTS: Overall, 69,658 (7.1%) patients experienced AKI, with 3,005 (0.3%) requiring new dialysis. On multivariable analyses, the factors most strongly associated with development of AKI included ST-segment elevation myocardial infarction (STEMI) presentation (odds ratio [OR]: 2.60; 95% confidence interval [CI]: 2.53 to 2.67), severe chronic kidney disease (OR: 3.59; 95% CI: 3.47 to 3.71), and cardiogenic shock (OR: 2.92; 95% CI: 2.80 to 3.04). The in-hospital mortality rate was 9.7% for patients with AKI and 34% for those requiring dialysis compared with 0.5% for patients without AKI (p < 0.001). After multivariable adjustment, AKI (OR: 7.8; 95% CI: 7.4 to 8.1, p < 0.001) and dialysis (OR: 21.7; 95% CI: 19.6 to 24.1; p < 0.001) remained independent predictors of in-hospital mortality.
CONCLUSIONS: Approximately 7% of patients undergoing a PCI experience AKI, which is strongly associated with in-hospital mortality. Defining strategies to minimize the risk of AKI in patients undergoing PCI are needed to improve the safety and outcomes of the procedure.

OBJECTIVE: This study sought to determine if an integrated healthcare system is selective and consistent in the use of angiography, as reflected by normal coronary rates.
BACKGROUND: Rates of normal coronary arteries with elective coronary angiography vary considerably among U.S. community hospitals. This variation may in part reflect incentives in fee-for-service care.
METHODS: Using national data from the Veterans Affairs (VA) Clinical Assessment Reporting and Tracking (CART) program representing all 76 VA cardiac catheterization laboratories, we evaluated all patients who underwent elective coronary angiography from October 2007 to September 2010. Normal coronary angiography was defined as <20% stenosis in all vessels. To assess hospital-level variation in normal coronary rates, we categorized hospitals by quartiles as defined by their proportion of normal coronaries.
RESULTS: Overall, 4,829 of 22,538 patients (21.4%) had normal coronary angiography. Hospital proportions of normal coronaries varied markedly (median hospital proportion 20.5%; interquartile range: 15.1% to 25.3%; range: 5.5% to 48.5%). Categorized as hospital quartiles, the median proportion of normal coronaries in the lowest quartile was 10.8%, as compared with a median proportion of 19.1% in the second lowest quartile, 23.1% in the second highest quartile, and 30.3% in the highest quartile. Hospitals with lower rates of normal coronaries had higher rates of obstructive coronary disease (59.2% vs. 51.3% vs. 52.6% vs. 44.3%; p < 0.001) and subsequent revascularization (38.1% vs. 33.9% vs. 31.5% vs. 29.3%; p < 0.001).
CONCLUSIONS: Approximately 1 in 5 patients undergoing elective coronary angiography in the VA had normal coronaries. This rate is lower than prior published studies in other systems. However, the observed hospital-level variation in normal coronary rates suggests opportunities to improve patient selection for diagnostic coronary angiography.