National Cardiovascular Disease Registry Research Articles

Chronic Kidney Disease Predisposes to Acute Congestive Heart Failure, Cardiogenic Shock, and Mortality in Patients Undergoing Percutaneous Coronary Intervention

The relations between degrees of chronic kidney disease (CKD) and congestive heart failure (CHF) events after percutaneous coronary intervention (PCI) are not well characterized. We sought to determine the relation between different stages of CKD and acute CHF events, including HF and cardiogenic shock (CS), and the impact of CKD stages on all-cause mortality after PCI. Patients who underwent PCI from 2009 to 2017 were identified from our institution's National Cardiovascular Disease Registry CathPCI Database. Patients were stratified by CKD stage 1 (estimated glomerular filtration rate [eGFR] ≥90 ml/min/1.73 m2), 2 (60 to 89), 3a (45 to 59), 3b (30 to 44), 4 (16 to 29), 5 (≤15), and current dialysis. The primary end point was composite HF events defined as acute HF or CS within 30 days after PCI, or in-hospital mortality, stratified by CKD and analyzed by multivariable regression after screening with univariate analysis (p <0.05 entry criteria). Patients with CKD stage 3a or worse had more composite HF events, with an increase in all components, compared with patients with CKD stages 1 to 2 (p <0.0001 for all comparisons). After multivariable adjustment, CKD stages 3a to 5 remained independent predictors of composite HF or in-hospital mortality events. eGFR remained a strong predictor of acute HF events after multivariable adjustment, with a model including eGFR and baseline and procedural characteristics achieving excellent discriminatory ability with area under the curve 0.92. In conclusion, baseline eGFR is a strong, independent predictor of acute HF events after PCI. CKD stages 3a to 5 independently predict HF events including HF decompensation and CS and are predictors of in-hospital mortality after PCI. Patients with baseline CKD may benefit from targeted interventions to limit acute HF events after PCI.

Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry.

PINNACLE FLX (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the WATCHMAN FLX LAA Closure Technology) demonstrated improved outcomes and low incidence of adverse events with the WATCHMAN FLX device in a controlled setting. The National Cardiovascular Disease Registry's Left Atrial Appendage Occlusion Registry was utilized to assess the safety and effectiveness of WATCHMAN FLX in contemporary clinical practice in the United States. The WATCHMAN FLX Device Surveillance Post Approval Analysis Plan used data from the Left Atrial Appendage Occlusion registry to identify patients undergoing WATCHMAN FLX implantation between August 2020 and September 2022. The key safety end point was defined as all-cause death, ischemic stroke, systemic embolism, or device or procedure-related events requiring open cardiac surgery or major endovascular intervention between device implantation and hospital discharge. Major adverse events were reported at hospital discharge, 45 days, and 1 year. Among 97 185 patients in the Left Atrial Appendage Occlusion registry undergoing WATCHMAN FLX, successful implantation occurred in 97.5% (n=94 784) of patients. The key safety end point occurred in 0.45% of patients. At 45 days post-procedure, all-cause death occurred in 0.81% patients, ischemic stroke in 0.23%, major bleeding in 3.1%, pericardial effusion requiring intervention in 0.50%, device-related thrombus in 0.44%, and device embolism in 0.04% patients. No peri-device leak was observed in 83.1% of patients at 45 days. At 1 year, the rate of all-cause death was 8.2%, the rate of any stroke was 1.5% (ischemic stroke, 1.2%), and major bleeding occurred in 6.4% of patients. In a large contemporary cohort of patients with the WATCHMAN FLX device, the rates of implant success and clinical outcomes through 1 year were comparable with the PINNACLE FLX study, demonstrating that favorable outcomes achieved in the pivotal approval study can be replicated in routine clinical practice.

A Comprehensive Framework for Evaluating the Value Created by Real-World Evidence for Diverse Stakeholders: The Case for Coordinated Registry Networks.

This manuscript presents a comprehensive framework for the assessment of the value of real-world evidence (RWE) in healthcare decision-making. While RWE has been proposed to overcome some limitations of traditional, one-off studies, no systematic framework exists to measure if RWE actually lowers the burden. This framework aims to fill that gap by providing conceptual approaches for evaluating the time and cost efficiencies of RWE, thus guiding strategic investments in RWE infrastructure. The framework consists of four components: (114th Congress. 21st Century Cures Act.; 2015. https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf .) identification of stakeholders using and producing RWE, (National Health Council. Glossary of Patient Engagement Terms. Published 2019. Accessed May 18. 2021. https://nationalhealthcouncil.org/glossary-of-patient-engagement-terms/ .) understanding value propositions on how RWE can benefit stakeholders, (Center for Drug Evaluation and Research. CDER Patient-Focused Drug Development. U.S. Food & Drug Administration.) defining key performance indicators (KPIs), and (U.S. Department of Health and Human Services - Food and Drug Administration: Center for Devices and Radiological Health and Center for Biologics Evaluation and Research. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Guidance for Industry and Food and Drug Administration Staff. 2017. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida .) establishing metrics and case studies to assess value. KPIs are categorized as 'better, faster, or cheaper" as an indicator of value: better focusing on high-quality actionable evidence; 'faster,' denoting time-saving in evidence generation, and 'cheaper,' emphasizing cost-efficiency decision compared to methodologies that do not involve data routinely collected in clinical practice. Metrics and relevant case studies are tailored based on stakeholder value propositions and selected KPIs that can be used to assess what value has been created by using RWE compared to traditional evidence-generation approaches and comparing different RWE sources. Operationalized through metrics and case studies drawn from the literature, the value of RWE is documented as improving treatment effect heterogeneity evaluation, expanding medical product labels, and expediting post-market compliance. RWE is also shown to reduce the cost and time required to produce evidence compared to traditional one-off approaches. An original example of a metric that measures the time saved by RWE methods to detect a signal of a product failure was presented based on analysis of the National Cardiovascular Disease Registry. The framework presented in this manuscript offers a comprehensive approach for evaluating the value of RWE, applicable to all stakeholders engaged in leveraging RWE for healthcare decision-making. Through the proposed metrics and illustrated case studies, valuable insights are provided into the heightened efficiency, cost-effectiveness, and improved decision-making within clinical and regulatory domains facilitated by RWE. While this framework is primarily focused on medical devices, it could potentially inform the determination of RWE value in other medical products. By discerning the variations in cost, time, and data utility among various evidence-generation methods, stakeholders are empowered to invest strategically in RWE infrastructure and shape future research endeavors.

Aetiology and predictors of major bleeding events in patients with heart failure with reduced ejection fraction undergoing percutaneous coronary intervention

ObjectivesWe sought to determine the relationship between the degree of left ventricular ejection fraction (LVEF) impairment and the frequency and type of bleeding events after percutaneous coronary intervention (PCI).DesignThis was...

Prescribing Trends of Renin-Angiotensin System Inhibitors and Mortality among Acute Coronary Syndrome Patients: Insights from the Malaysian National Cardiovascular Disease Registry.

Despite guideline recommendations, suboptimal prescription rates of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) have been observed in patients with acute coronary syndrome. This study aimed to examine the temporal trends, variations, and mortality outcomes among acute coronary syndrome patients prescribed ACEIs/ARBs in the multi-ethnic population of Malaysia. This retrospective study utilized data from the Malaysian National Cardiovascular Disease-Acute Coronary Syndrome registry, encompassing consecutive patient records from 2008 to 2017 (N = 60,854). Ten-year temporal trends of on-discharge ACEIs/ARBs prescription were examined. Demographics, clinical characteristics and 1-year all-cause mortality outcomes were compared between patients prescribed and not prescribed ACEIs/ARBs. The 10-year prescription rate of on-discharge ACEIs/ARBs was 52.8% (n = 32,140), with a significant decline over the years [linear trend test, P = 0.008; SD = 0.03; SE = 0.001; 95% CI = 0.55-0.64]. Patients aged ≥65 years (aOR = 0.79; 95% CI = 0.73-0.86) were less likely to be prescribed ACEIs/ARBs than those aged <65 years. In addition, patients with comorbid diabetes mellitus (DM) (aOR = 0.85; 95% CI = 0.79-0.92) and chronic kidney disease (CKD) (aOR = 0.34; 95% CI = 0.30-0.40) were significantly less likely to receive ACEIs/ARBs. IPW-adjusted survival analysis revealed a 38% lower 1-year all-cause mortality rate in patients prescribed on-discharge ACEIs/ARBs (HR = 0.62; 95% CI = 0.56-0.69; P < 0.001). Acute coronary syndrome patients with concomitant DM and CKD were less likely to receive on-discharge ACEIs/ARBs in Malaysia. Suboptimal prescription rates of ACEIs/ARBs persisted over the 10-year period, despite improved 1-year survival in ACS patients prescribed ACEIs/ARBs.

The prognostic value of artificial intelligence to predict cardiac amyloidosis in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement.

Cardiac amyloidosis (CA) is common in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR). Cardiac amyloidosis has poor outcomes, and its assessment in all TAVR patients is costly and challenging. Electrocardiogram (ECG) artificial intelligence (AI) algorithms that screen for CA may be useful to identify at-risk patients. In this retrospective analysis of our institutional National Cardiovascular Disease Registry (NCDR)-TAVR database, patients undergoing TAVR between January 2012 and December 2018 were included. Pre-TAVR CA probability was analysed by an ECG AI predictive model, with >50% risk defined as high probability for CA. Univariable and propensity score covariate adjustment analyses using Cox regression were performed to compare clinical outcomes between patients with high CA probability vs. those with low probability at 1-year follow-up after TAVR. Of 1426 patients who underwent TAVR (mean age 81.0 ± 8.5 years, 57.6% male), 349 (24.4%) had high CA probability on pre-procedure ECG. Only 17 (1.2%) had a clinical diagnosis of CA. After multivariable adjustment, high probability of CA by ECG AI algorithm was significantly associated with increased all-cause mortality [hazard ratio (HR) 1.40, 95% confidence interval (CI) 1.01-1.96, P = 0.046] and higher rates of major adverse cardiovascular events (transient ischaemic attack (TIA)/stroke, myocardial infarction, and heart failure hospitalizations] (HR 1.36, 95% CI 1.01-1.82, P = 0.041), driven primarily by heart failure hospitalizations (HR 1.58, 95% CI 1.13-2.20, P = 0.008) at 1-year follow-up. There were no significant differences in TIA/stroke or myocardial infarction. Artificial intelligence applied to pre-TAVR ECGs identifies a subgroup at higher risk of clinical events. These targeted patients may benefit from further diagnostic evaluation for CA.

Abstract 14695: Artificial Intelligence Applied to the Electrocardiogram Predicts Outcomes in Patients With Severe Aortic Stenosis and Potential Cardiac Amyloidosis Undergoing Transcatheter Aortic Valve Replacement

Introduction: Cardiac amyloidosis (CA) has been suggested to be common (up to 16%) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR). CA has poorer outcomes and its assessment in all TAVR patients may be costly and challenging. Hypothesis: CA may be screened for with an artificial intelligence (AI) clinical predictive model applied to pre-TAVR ECGs, and high probability (&gt;50%) for CA may be associated with worse clinical outcomes. Methods: In this retrospective analysis of the Mayo institutional National Cardiovascular Disease Registry (NCDR)-TAVR, patients undergoing a TAVR between Jan-2012 and Dec-2017 were included. Pre-TAVR ECGs were analyzed by the AI predictive model for CA embedded in the EMR. EMRs were reviewed to assess for a clinical diagnosis of CA in those identified as high probability (&gt;50%) by the AI tool. Clinical outcomes on 1 year follow-up were extracted from the NCDR-TAVR database and Kaplan-Meier curves were created to compare patients with high CA probability (≥50%) versus those with low probability (&lt;50%). Results: Of 1070 patients who underwent TAVR (mean age 81.1± 8.5 years, 58.2% male), 263 (24.6%) had ≥50% probability for CA on pre-procedure ECG. Only 18 (1.7%) of these had clinical diagnosis of CA. In the survival analysis, high probability of CA by AI tool was associated with higher all-cause mortality (HR 1.60, 95%CI 1.09-2.34, p=0.01) and greater HF admissions (HR 1.59, 95%CI 1.08-2.35, p&lt;0.01). Neither TIA/stroke nor myocardial infarction were statistically significant. MACE (TIA/stroke, myocardial infarction, heart failure admissions) was higher in the ≥50% CA probability group (HR 1.68, 95%CI 1.17-2.40, p&lt;0.01), (Figure) . Conclusion: CA is clinically underdiagnosed in patients undergoing TAVR. AI applied to pre-TAVR ECGs suggesting higher probability for CA identifies a subgroup at higher risk of clinical events, who may benefit from further diagnostic evaluation for CA.

In-hospital risk stratification algorithm of Asian elderly patients

Limited research has been conducted in Asian elderly patients (aged 65 years and above) for in-hospital mortality prediction after an ST-segment elevation myocardial infarction (STEMI) using Deep Learning (DL) and Machine Learning (ML). We used DL and ML to predict in-hospital mortality in Asian elderly STEMI patients and compared it to a conventional risk score for myocardial infraction outcomes. Malaysia's National Cardiovascular Disease Registry comprises an ethnically diverse Asian elderly population (3991 patients). 50 variables helped in establishing the in-hospital death prediction model. The TIMI score was used to predict mortality using DL and feature selection methods from ML algorithms. The main performance metric was the area under the receiver operating characteristic curve (AUC). The DL and ML model constructed using ML feature selection outperforms the conventional risk scoring score, TIMI (AUC 0.75). DL built from ML features (AUC ranging from 0.93 to 0.95) outscored DL built from all features (AUC 0.93). The TIMI score underestimates mortality in the elderly. TIMI predicts 18.4% higher mortality than the DL algorithm (44.7%). All ML feature selection algorithms identify age, fasting blood glucose, heart rate, Killip class, oral hypoglycemic agent, systolic blood pressure, and total cholesterol as common predictors of mortality in the elderly. In a multi-ethnic population, DL outperformed the TIMI risk score in classifying elderly STEMI patients. ML improves death prediction by identifying separate characteristics in older Asian populations. Continuous testing and validation will improve future risk classification, management, and results.

Abstract 82: Post Coronary Angioplasty; Why Did My Patient Die?

Introduction: PCI interventions carry the risk of mortality. Minimizing by appropriate selection of patients, procedural technique, aftercare is critical. Despite advances, mortality risk has not significantly changed. Registries have been developed to assess and report outcomes/quality of care. Methods: Mortalities identified in the National Cardiovascular Disease Registry [NCDR] database from 2017-2020 @ Stony Brook University Hospital were identified and reviewed. The 2017 mortalities were compared with Vizient [Analytics providing cost/quality/value benchmarking &amp; practice improvement feedback] predictors of mortality (case mix index [CMI]) and NYS PCI database which use different risk adjusters. Results: There were 79 mortalities over 4 years (average age 79, M:F ratio 2.07 [54/26], 76 died in-house). Cause of death [59 cardiac, 8 neurologic, 4 infection, 1 hemorrhage, 1 pulmonary, 3 unknown; 10 cases attributed to surgery]. Mortality rates remained constant over time. Vizient expected mortality rates show poor correlation with NCDR predictions, which may reflect in part patient selection and unadjusted comorbidity. NCDR correlation with the more restrictive risk adjusted NYS DOH mortality rates is better than for Vizient. NCDR mortality for 2017 was 1.4% [21/1503]; NYS DOH 30 day reported OMR1.76%, EMR 1.36%, RAMR of 1.46% for all [26/1,476] cases and RAMR of 0.95% for non-emergent [1,150] cases. Conclusions: The NCDR provides a useful tool to benchmark PCI mortality, but unadjusted comorbidity, as demonstrated by mismatches in predicted outcomes] adversely affects observed mortality. Increased attention to patient selection may provide improvements in outcomes, decrease mortality risks, and improve value. Value: Improving patient selection improves NCDR mortality and result in lower costs and better reported outcomes. Patients, Providers and Payers may benefit from the provision of appropriate services and improved outcomes..

Potential Impact of the 2019 ACC/AHA Guidelines on the Primary Prevention of Cardiovascular Disease Recommendations on the Inappropriate Routine Use of Aspirin and Aspirin Use Without a Recommended Indication for Primary Prevention of Cardiovascular Disease in Cardiology Practices: Insights From the NCDR PINNACLE Registry.

Aspirin is recommended in patients with atherosclerotic cardiovascular disease for secondary prevention. In patients without atherosclerotic cardiovascular disease and not at high 10-year risk, there is no evidence aspirin reduces adverse cardiovascular events and it could increase bleeding. The 2019 American College of Cardiology/American Heart Association Guidelines on Primary Prevention of Cardiovascular Disease state that aspirin may be considered for primary prevention (class IIb) in patients 40 to 70 years that are at higher risk of atherosclerotic cardiovascular disease and that routine use of aspirin should be avoided (class III:Harm) for patients >70 years. We examined the frequency of patients on aspirin for primary prevention that would have been considered unindicated or potentially harmful per the recent guideline where aspirin discontinuation may be beneficial. To assess the potential impact, within the National Cardiovascular Disease Registry Practice Innovation and Clinical Excellence Registry, we assessed 855 366 patients from 400 practices with encounters between January 1, 2018 and March 31, 2019, that were receiving aspirin for primary prevention. We defined inappropriate use as the use of aspirin in patients <40 or >70 years and use without a recommended indication as use of aspirin in patients 40 to 70 years with low, borderline, or intermediate 10-year atherosclerotic cardiovascular disease risk. Frequency of inappropriate use and use without a recommended indication were calculated and practice-level variation was evaluated using the median rate ratio. Inappropriate use occurred in 27.6% (193 674/701 975) and use without a recommended indication in 26.0% (31 810/122 507) with significant practice-level variation in inappropriate use (predicted median practice-level rate 33.5%, interquartile range, 24.1% to 40.8%; median rate ratio, 1.71 [95% CI, 1.67-1.76]). Immediately before the 2019 American College of Cardiology/American Heart Association Guidelines on Primary Prevention of Cardiovascular Disease, over one-fourth of patients in this national registry were receiving aspirin for primary prevention inappropriately or without a recommended indication with significant practice-level variation. These findings help to determine the potential impact of guideline recommendations on contemporary use of aspirin for primary prevention.

Comparing Major Bleeding Risk in Outpatients With Atrial Fibrillation or Flutter by Oral Anticoagulant Type (from the National Cardiovascular Disease Registry's Practice Innovation and Clinical Excellence Registry)

Direct oral anticoagulants (DOACs) have a favorable bleeding risk profile in patients with atrial fibrillation (AF). However, the safety of individual DOACs relative to warfarin for specific bleeding outcomes is less certain. We identified 423,450 patients with AF between 2013 to 2015 in the NCDR PINNACLE national ambulatory registry matched to the Centers for Medicare and Medicaid Services database. Outcomes included time to first major bleed, intracranial hemorrhage (ICH), major gastrointestinal bleed (GIB), or other major bleed. We estimated the association of OAC with bleeding using Cox proportional hazard models. The median duration of follow-up was 1.4 years. OACs were used in 64% of AF patients (66% warfarin, 15% rivaroxaban, 12% dabigatran, and 7% apixaban). A major bleeding event occurred in 6.9% of patients. Compared with warfarin users, fewer patients experienced ICH with the use of rivaroxaban (HR 0.73; 95% CI 0.64 to 0.84), dabigatran (HR 0.56; 95% CI 0.48 to 0.65), and apixaban (HR 0.70; 95% CI 0.55 to 0.90). The risk of major GIB was higher in rivaroxaban users (HR 1.20; 95% CI 1.12 to 1.27), and lower in dabigatran (HR 0.88; 95% CI 0.82 to 0.95) and apixaban (HR 0.84; 95% CI 0.74 to 0.95) users. For any DOAC versus warfarin, age (≥75 or <75 years) interacted with major bleeding (HR 0.93 vs 0.78; p <0.001), GIB (HR 1.10 vs 0.82; p <0.001), and other major bleeding (HR 0.93 vs 0.80; p <0.001). In conclusion, our results suggest that the safety of DOACs is superior to warfarin in AF patients, except with rivaroxaban and GIB. Age ≥75 years attenuated the relative safety benefits of DOACs.

Abstract 16902: The Effect of Kidney Function on Antithrombotic Regimen Among Patients With Atrial Fibrillation and Acute Myocardial Infarction: Insights From the National Cardiovascular Disease Registry’s Acute Coronary Treatment and Intervention Outcomes Network Registry

Introduction: The impact of kidney function in selecting antithrombotic therapy at hospital discharge for patients with atrial fibrillation (AF) who survive an acute myocardial infarction (AMI) is uncertain. Hypothesis: We hypothesized that kidney dysfunction is associated with decreased oral anticoagulant (OAC) use in AF patients who survive AMI. Methods: We studied 30,308 AF patients at 791 hospitals who survived AMI and were hospitalized between January 2015 and December 2017 (Acute Coronary Treatment and Intervention Outcomes Network Registry). We separated patients into 4 mutually exclusive groups: triple antithrombotic therapy (TAT), dual-antiplatelet therapy (DAPT), dual antithrombotic therapy excluding DAPT (DAT), and single therapy. Logistic regression was used to explore the trend for each antithrombotic strategy across CKD stage. Results: Of the 30,308 patients included in this analysis, 6,618 were on TAT (22%), 12,920 on DAPT (43%), 6,148 on DAT (20%), and 4,622 were on single therapy (15%). Overall, 46% of patients were discharged on an OAC (warfarin 22%; apixaban 14%; rivaroxaban 8%; dabigatran 2%). Patients with higher CHA 2 DS 2 -VASC scores (≥4) were more likely to be discharged on oral anticoagulation, except patients with GFR &lt; 15 ml/min/1.73m 2 . Compared to patients with normal kidney function, patients with GFR &lt; 30 ml/min/1.73m 2 had lower rates of TAT use (23% vs. 18%) despite higher warfarin use (20% vs. 27%). Within each antithrombotic discharge strategy, there was no significant trend across GFR strata among patients with in-hospital PCI ( Figure ). Conclusion: Significant heterogeneity in antithrombotic discharge strategy was seen among AF patients who survived AMI, however, the trend of each strategy across CKD stage was not significant among patients with in-hospital PCI. More research is needed to understand whether a particular antithrombotic strategy has improved outcomes in this population.

Complications Associated With Implantable Cardioverter Defibrillators in Adults With Congenital Heart Disease or Left Ventricular Noncompaction Cardiomyopathy (From the NCDR® Implantable Cardioverter-Defibrillator Registry)

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.

The Outcomes, Patient Health Status, and Efficiency IN Chronic Total Occlusion Hybrid Procedures registry: rationale and design.

Patients with chronic total occlusions of a coronary artery represent a complex, yet common, clinical conundrum among patients with ischemic heart disease. Chronic total occlusion angioplasty is increasingly being used as a treatment for these complex lesions. There is a compelling need to better quantify the safety, efficacy, benefits, and costs of the procedure. To address these gaps in knowledge, we designed the Outcomes, Patient Health Status, and Efficiency IN Chronic Total Occlusion Hybrid Procedures (OPEN CTO) study, an investigator-initiated multicenter, single-arm registry including 12 centers with a planned enrollment of 1000 patients. To ensure the accuracy of our observations, we used a unique auditing process through the National Cardiovascular Disease Registries' Cath/PCI Registry, angiographic core lab analysis, clinical events adjudication, and a systematic collection of patient-reported outcomes and costs. Between 21 January 2014 and 22 July 2015, 1000 patients were enrolled in OPEN CTO. A total of 28 patients either refused (N=26) or were missed by the screening process (N=2). In the National Cardiovascular Disease Registry Cath/PCI registry audit, there were 1096 chronic total occlusion-percutaneous coronary intervention procedures that were performed by participating operators during the time they enrolled in OPEN CTO. Overall, 987 of those patients could be definitively matched to an OPEN CTO enrolled patient (enrolled group). The remaining 109 were considered to be not enrolled in OPEN CTO (not enrolled group). Compared with the enrolled group, the patients in the nonenrolled group were less frequently of White race and more frequently of Hispanic origin. Procedural outcomes including National Cardiovascular Disease Registry-defined technical success, procedural success, and major adverse coronary events rates were similar. OPEN CTO is the most comprehensive and rigorously collected dataset to date that will provide unique insights into the success, safety, benefits, and the costs of chronic total occlusion-percutaneous coronary intervention using a reproducible technical approach to patients with these complex lesions.

Circulation : Clinical Summaries

<i>Circulation</i> : Clinical Summaries

Does Age Influence Cardiac Resynchronization Therapy Use and Outcome?

ObjectivesThis study sought to describe the use of CRT-D and its association with survival for older patients. BackgroundMany patients who receive cardiac resynchronization therapy with defibrillator (CRT-D) in practice are older than those included in clinical trials. MethodsWe identified patients undergoing ICD implantation in the National Cardiovascular Disease Registry (NCDR) ICD registry from 2006 to 2009, who also met clinical trial criteria for CRT, including left ventricular ejection fraction (LVEF) ≤35%, QRS ≥120 ms, and New York Heart Association (NYHA) functional class III or IV. NCDR registry data were linked to the social security death index to determine the primary outcome of time to death from any cause. We identified 70,854 patients from 1,187 facilities who met prior trial criteria for CRT-D. The mean age of the 58,147 patients receiving CRT-D was 69.4 years with 6.4% of patients age 85 or older. CRT use was 80% or higher among candidates in all age groups. Follow-up was available for 42,285 patients age ≥65 years at 12 months. ResultsReceipt of CRT-D was associated with better survival at 1 year (82.1% vs. 77.1%, respectively) and 4 years (54.0% vs. 46.2% , respectively) than in those receiving only an ICD (p < 0.001). The CRT association with improved survival was not different for different age groups (p = 0.86 for interaction). ConclusionsMore than 80% of older patients undergoing ICD implantation who were candidates for a CRT-D received the combined device. Mortality in older patients undergoing ICD implantation was high but was lower for those receiving CRT-D.

Inappropriate use of aspirin for primary prevention

Finer points Current guidelines vary slightly in their exact recommendations for aspirin use in the primary prevention setting. However, most consider aspirin appropriate for primary prevention when the 10-year CV risk is 6% or more. To determine the frequency of inappropriate use of aspirin in the primary prevention setting, researchers examined a cohort of patients receiving aspirin for primary prevention who were enrolled in the American College of Cardiology’s National Cardiovascular Disease Registry’s Practice Innovation and Clinical Excellence (PINNACLE) registry. Inappropriate aspirin use was characterized as use in patients with a 10-year CV risk of less than 6% by the Framingham CV risk assessment tool. A total of 68,808 patients were identi ed from 119 medical practices across the United States from January 2008 to June 2013. Of the 68,808 patients reviewed, 7,972 (11.6%) were classi ed as inappropriately receiving aspirin therapy for primary prevention. The mean 10-year CV risk in the inappropriate-use group was 4% compared with 24.5% in the appropriate-use group (P < 0.001). An assessment of individual practices revealed substantial variation for inappropriate aspirin use across practices, ranging from 0% to 71.8% (median 10.1%). However, only modest regional variations were observed in the northeast, midwest, south, and west.

Frequency and Practice-Level Variation in Inappropriate Aspirin Use for the Primary Prevention of Cardiovascular Disease: Insights From the National Cardiovascular Disease Registry’s Practice Innovation and Clinical Excellence Registry

BackgroundAmong patients without cardiovascular disease (CVD) and low 10-year CVD risk, the risks of gastrointestinal bleeding and hemorrhagic strokes associated with aspirin use outweigh any potential atheroprotective benefit. According to the guidelines on primary prevention of CVD, aspirin use is considered appropriate only in patients with 10-year CVD risk ≥6% and inappropriate in patients with 10-year CVD risk <6%. ObjectivesThe goal of this study was to examine the frequency and practice-level variation in inappropriate aspirin use for primary prevention in a large U.S. nationwide registry. MethodsWithin the National Cardiovascular Disease Registry’s Practice Innovation and Clinical Excellence registry, we assessed 68,808 unique patients receiving aspirin for primary prevention from 119 U.S. practices. The frequency of inappropriate aspirin use was determined for primary prevention (aspirin use in those with 10-year CVD risk <6%). Using hierarchical regression models, the extent of practice-level variation using the median rate ratio (MRR) was assessed. ResultsInappropriate aspirin use frequency was 11.6% (7,972 of 68,808) in the overall cohort. There was significant practice-level variation in inappropriate use (range 0% to 71.8%; median 10.1%; interquartile range 6.4%) for practices; adjusted MRR was 1.63 (95% confidence interval [CI]: 1.47 to 1.77). Results remained consistent after excluding 21,052 women age ≥65 years (inappropriate aspirin use 15.2%; median practice-level inappropriate aspirin use 13.8%; interquartile range 8.2%; adjusted MRR 1.61 [95% CI: 1.46 to 1.75]) and after excluding patients with diabetes (inappropriate aspirin use 13.9%; median practice-level inappropriate aspirin use 12.4%; interquartile range 7.6%; adjusted MRR 1.55 [95% CI: 1.41 to 1.67]). ConclusionsMore than 1 in 10 patients in this national registry were receiving inappropriate aspirin therapy for primary prevention, with significant practice-level variations. Our findings suggest that there are important opportunities to improve evidence-based aspirin use for the primary prevention of CVD.

Practice-Level Variation in Use of Recommended Medications Among Outpatients With Heart Failure

Background— The objective of this study is to examine practice-level variation in rates of guideline-recommended treatment for outpatients with heart failure and reduced ejection fraction, and to examine the association between treatment variation and practice site, independent of patient factors. Methods and Results— Cardiology practices participating in the National Cardiovascular Disease Registry Practice Innovation and Clinical Excellence registry from July 2008 to December 2010 were evaluated. Practice rates of treatment with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers and β-blockers and an optimal combined treatment measure were determined for patients with heart failure and reduced ejection fraction and no documented contraindications. Multivariable hierarchical regression models were adjusted for demographics, insurance status, and comorbidities. A median rate ratio was calculated for each therapy, which describes the likelihood that the treatment of a patient with given comorbidities would differ at 2 randomly selected practices. We identified 12 556 patients from 45 practices. The unadjusted practice-level prescription rates ranged from 44% to 100% for angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (median, 85%; interquartile range, 75%–89%), from 49% to 100% for β-blockers (median, 92%; interquartile range, 83%–95%), and from 37% to 100% for optimal combined treatment (median, 79%; interquartile range, 66%–85%). The adjusted median rate ratio was 1.11 (95% confidence interval, 1.08–1.18) for angiotensin-converting enzyme inhibitors/angiotensin receptor blockers therapy, 1.08 (95% confidence interval, 1.05–1.15) for β-blockers therapy, and 1.17 (1.13–1.26) for optimal combined treatment. Conclusions— Variation in the use of guideline-recommended medications for patients with heart failure and reduced ejection fraction exists in the outpatient setting. Addressing practice-level differences may be an important component of improving quality of care for patients with heart failure and reduced ejection fraction.

Secondary prevention of atherosclerotic cardiovascular disease in older adults: a scientific statement from the American Heart Association.

Since the initial scientific statement on Secondary Prevention of Coronary Heart Disease (CHD) in the Elderly was published in 2002,1 several trends have continued that make an update highly appropriate. First, the graying of the US population and those of other industrialized countries has progressed unabated because more adults are surviving into their senior years. The number of Americans aged ≥75 years was estimated at 18.6 million in 2010, representing ≈6% of the population,2 and it is expected to double by 2050. The population aged ≥85 years is growing the most rapidly, with numbers expected to reach 19.5 million by 2040. In 2008, 67% of the 811 940 cardiovascular deaths in the United States occurred in people aged ≥75 years.3 In parallel to this increase in the older adult demographic, the number of Americans with CHD has increased to an estimated 16.3 million, more than half of whom are >65 years of age.3 Similarly, 7 million have had a stroke, the incidence of which approximately doubles with successive age decades after 45 to 54 years.3 Peripheral artery disease (PAD) affects 8 to 10 million Americans, the majority of whom are >65 years of age. Between 2015 and 2030, annual US costs related to atherosclerotic cardiovascular disease (ASCVD) are projected to increase from $84.8 billion to $202 billion.3 Moreover, given that ASCVD often undermines functional capacity and independence and increases reliance on long-term care, indirect expenses related to ASCVD are also expected to increase. Thus, the need for effective secondary prevention measures in the older adult population with known ASCVD has never been greater. Notably, the 2011 American Heart Association (AHA)/American College of Cardiology Foundation (ACCF) updated guidelines for secondary prevention of CHD broadened …