The National Cardiovascular Data Registry Data Quality Program 2020: JACC State-of-the-Art Review.

The National Cardiovascular Data Registry is a group of registries maintained by the American College of Cardiology Foundation. These registries are used by a diverse constituency to improve the quality and outcomes of cardiovascular care, to assess the safety and effectiveness of new therapies, and for research. To achieve these goals, registry data must be complete and reliable. In this article, we review the process of National Cardiovascular Data Registry data collection, assess data completeness and integrity, and report on the current state of the data. Registry data are complete. Accuracy is very good but variable, and there is room for improvement. Knowledge of the quality of data is essential to ensuring its appropriate use.

Development and validation of a predictive model for bleeding after peripheral vascular intervention: A report from the National Cardiovascular Data Registry Peripheral Vascular Interventions Registry.

OBJECTIVES: To develop a model to predict risk of in-hospital bleeding following endovascular peripheral vascular intervention. BACKGROUND: Peri-procedural bleeding is a common, potentially preventable complication of catheter-based peripheral vascular procedures and is associated with increased mortality. We used the National Cardiovascular Data Registry (NCDR) Peripheral Vascular Interventions (PVI) Registry to develop a novel risk-prediction model to identify patients who may derive the greatest benefit from application of strategies to prevent bleeding. METHODS: We examined all patients undergoing lower extremity PVI at 76 NCDR PVI hospitals from 2014 to 2017. Patients with acute limb ischemia (n = 1600) were excluded. Major bleeding was defined as overt bleeding with a hemoglobin (Hb) drop of ≥ 3 g/dl, any Hb decline of ≥ 4 g/dl, or a blood transfusion in patients with pre-procedure Hb ≥ 8 g/dl. Hierarchical multivariable logistic regression was used to develop a risk model to predict major bleeding. Model validation was performed using 1000 bootstrapped replicates of the population after sampling with replacement. RESULTS: Among 25,382 eligible patients, 1017 (4.0%) developed major bleeding. Predictors of bleeding included age, female sex, critical limb ischemia, non-femoral access, prior heart failure, and pre-procedure hemoglobin. The model demonstrated good discrimination (optimism corrected c-statistic = 0.67), calibration (corrected slope = 0.98, intercept of -0.04) and range of predicted risk (1%-18%). CONCLUSIONS: Post-procedural PVI bleeding risk can be predicted based upon pre- and peri-procedural patient characteristics. Further studies are needed to determine whether this model can be utilized to improve procedural safety through developing and targeting bleeding avoidance strategies.

Acute Kidney Injury Following In-Patient Lower Extremity Vascular Intervention: From the National Cardiovascular Data Registry.

OBJECTIVES: The authors analyzed data from the NCDR (National Cardiovascular Data Registry) PVI Registry and defined acute kidney injury (AKI) as increased creatinine of ≥0.3 mg/dl or 50%, or a new requirement for dialysis after PVI. BACKGROUND: AKI is an important and potentially modifiable complication of peripheral vascular intervention (PVI). The incidence, predictors, and outcomes of AKI after PVI are incompletely characterized. METHODS: A hierarchical logistic regression risk model using pre-procedural characteristics associated with AKI was developed, followed by bootstrap validation. The model was validated with data submitted after model creation. An integer scoring system was developed to predict AKI after PVI. RESULTS: Among 10,006 procedures, the average age of patients was 69 years, 58% were male, and 52% had diabetes. AKI occurred in 737 (7.4%) and was associated with increased in-hospital mortality (7.1% vs. 0.7%). Reduced glomerular filtration rate, hypertension, diabetes, prior heart failure, critical or acute limb ischemia, and pre-procedural hemoglobin were independently associated with AKI. The model to predict AKI showed good discrimination (optimism corrected c-statistic = 0.68) and calibration (corrected slope = 0.97, intercept of -0.07). The integer point system could be incorporated into a useful clinical tool because it discriminates risk for AKI with scores ≤4 and ≥12 corresponding to the lower and upper 20% of risk, respectively. CONCLUSIONS: AKI is not rare after PVI and is associated with in-hospital mortality. The NCDR PVI AKI risk model, including the integer scoring system, may prospectively estimate AKI risk and aid in deployment of strategies designed to reduce risk of AKI after PVI.

Paclitaxel-coated devices in the treatment of femoropopliteal stenosis among patients ≥65 years old: An ACC PVI Registry Analysis.

BACKGROUND: The connection between paclitaxel-coated devices (PCD) use during peripheral vascular interventions (PVI) and mortality is debated. We aimed to analyze patterns of PCD use and the safety and effectiveness of PCD use in the superficial femoral and/or popliteal arteries. METHODS: Patients undergoing PVI of femoropopliteal lesions with and without PCD between January 1, 2015 and June 30, 2017 were compared using the American College of Cardiology's National Cardiovascular Data Registry PVI Registry. Outcomes were derived from Centers for Medicare & Medicaid claims data. The primary outcome was all-cause mortality at 6-, 12-, and 24-months following PVI. Inverse probability weighting and frailty models were used to assess the differences between groups. The analysis was IRB-approved. RESULTS: In the overall cohort consisting of 6,302 femoropopliteal PVIs, PCD-PVI patients were more likely to be treated for claudication (63.5% vs 51.3%, P< .001), less likely to have a chronic total occlusion (24.6% vs 34.7%, P < .001), and more likely to be treated in certain geographic and practice settings. In the analytic cohort consisting of 1,666 femoropopliteal PVIs with linked claims outcomes (888 PCD-PVI, 53.3%), unadjusted rates of all outcomes were lower in PCD-PVI patients. After adjustment, there were no significant differences in mortality following PCD-PVI versus non-PCD PVI at 1 year (adjusted RR 0.78, 95% CI 0.60-1.01, P= .055) or 2 years (aRR 0.98, 95% CI 0.77-1.24, P= .844). CONCLUSION: There were significant differences between the patients in whom and settings in which PCD-PVI was versus was not used. PCD-PVI was not associated with an increased risk of 2-year mortality in real-world use.

Expanding opportunities to understand quality and outcomes of peripheral vascular interventions: The ACC NCDR PVI Registry.

Lower extremity peripheral artery disease (PAD) and cerebrovascular disease (CeVD) are prevalent conditions in the United States, and both are associated with significant morbidity (eg, stroke, myocardial infarction, and limb loss) and increased mortality. With a growth in invasive procedures for PAD and CeVD, this demands a more clear responsibility and introduces an opportunity to study how patients are treated and evaluate associated outcomes. The American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Peripheral Vascular Intervention (PVI) Registry is a prospective, independent collection of data elements from individual patients at participating centers, and it is a natural extension of the already robust NCDR infrastructure. As of September 20, 2018, data have been collected on 45,316 lower extremity PVIs, 12,417 carotid artery stenting procedures, and 11,027 carotid endarterectomy procedures at 208 centers in the United States. The purpose of the present report is to describe the patient and procedural characteristics of the overall cohort and the methods used to design and implement the registry. In collecting these data, ACC and ACC PVI Registry have the opportunity to play a pivotal role in scientific evidence generation, medical device surveillance, and creation of best practices for PVI and carotid artery revascularization.

Bleeding Complications in Lower-Extremity Peripheral Vascular Interventions: Insights From the NCDR PVI Registry.

OBJECTIVES: This study sought to assess periprocedural bleeding complications in lower-extremity peripheral vascular interventions (PVIs). BACKGROUND: Few studies have examined the incidence, predictors, or outcomes of periprocedural bleeding after lower-extremity PVI. METHODS: The study examined patients undergoing PVI at 76 hospitals in the National Cardiovascular Data Registry PVI registry from 2014 to 2016. Post-PVI major bleeding was defined as any overt bleeding with a hemoglobin (Hb) drop of ≥3 g/dl, any Hb decline of ≥4 g/dl, or blood transfusion in patients with pre-procedure Hb >8 g/dl within 72 h of their procedure. Hierarchical multivariable logistic regression was used to identify factors independently associated with post-PVI bleeding. The study also examined adjusted in-hospital mortality among patients with or without major bleeding complications. RESULTS: Among 18,289 PVI procedures, major bleeding occurred in 744 (4.10%). Patient characteristics independently associated with bleeding included age, female sex, heart failure, pre-procedural hemoglobin <12 g/dl, nonelective PVI, and critical limb ischemia on presentation. Procedural characteristics associated with bleeding included nonfemoral vascular access, use of thrombolytic therapy, PVI of the aortoiliac segment, and multilesion interventions, whereas use of closure devices was associated with less bleeding. All-cause in-hospital mortality was higher in patients who experienced bleeding than in those who did not (6.60% vs. 0.30%; p < 0.001; adjusted hazard ratio: 10.9; 95% confidence interval: 6.9 to 17.0). CONCLUSIONS: Major bleeding occurred in 4.10% of lower-extremity PVI procedures and was associated with several patient and procedural characteristics, as well as in-hospital mortality. These insights can be incorporated into strategies to reduce periprocedural bleeding after PVI.

Patient Radiation Dosage During Lower Extremity Endovascular Intervention.

OBJECTIVES: The aims of this study were to determine the incidence of actionably high radiation dosages and to identify predictors of increased patient dosage. BACKGROUND: Peripheral endovascular intervention using fluoroscopic imaging has become a mainstay of treatment for lower extremity peripheral artery disease but exposes patients to ionizing radiation. METHODS: Patient radiation dosage, quantified as dose-area product (DAP), was obtained from the National Cardiovascular Data Registry Peripheral Vascular Intervention Registry. The percentage of procedures exceeding a DAP of 500 Gy · cm2, the threshold above which follow-up for radiation-related adverse effects is indicated by the National Council on Radiation Protection and Measurements, was determined. A multivariate regression model was generated to identify patient and procedural factors associated with increasing DAP. RESULTS: Among 17,174 procedures performed at 73 sites, patient DAP exceeded 500 Gy · cm2 in 7%. Independent predictors of increased patient DAP in order from greatest magnitude of effect included more proximal lesion location, bifurcation lesion, male sex, diabetes, hypertension, prior percutaneous coronary intervention, increasing lesion length, and increasing body mass index; antegrade vascular access, critical limb ischemia, and increasing age predicted decreased DAP. CONCLUSIONS: Radiation dosage with the potential for tissue injury occurs in 1 of every 14 patients undergoing lower extremity endovascular interventions, and all such patients are exposed to the potential for subsequent malignancy. Pre-procedural assessment of patients' risk for elevated radiation dosage may allow targeted use of radiation mitigation strategies in patients at increased risk for elevated exposure.

2018 ACC/HRS/NASCI/SCAI/SCCT Expert Consensus Document on Optimal Use of Ionizing Radiation in Cardiovascular Imaging-Best Practices for Safety and Effectiveness, Part 2: Radiological Equipment Operation, Dose-Sparing Methodologies, Patient and Medical Personnel Protection.

The stimulus to create this document was the recognition that ionizing radiation-guided cardiovascular procedures are being performed with increasing frequency, leading to greater patient radiation exposure and, potentially, to greater exposure to clinical personnel. While the clinical benefit of these procedures is substantial, there is concern about the implications of medical radiation exposure. ACC leadership concluded that it is important to provide practitioners with an educational resource that assembles and interprets the current radiation knowledge base relevant to cardiovascular procedures. By applying this knowledge base, cardiovascular practitioners will be able to select procedures optimally, and minimize radiation exposure to patients and to clinical personnel. "Optimal Use of Ionizing Radiation in Cardiovascular Imaging - Best Practices for Safety and Effectiveness" is a comprehensive overview of ionizing radiation use in cardiovascular procedures and is published online. To provide the most value to our members, we divided the print version of this document into 2 focused parts. "Part I: Radiation Physics and Radiation Biology" addresses radiation physics, dosimetry and detrimental biologic effects. "Part II: Radiologic Equipment Operation, Dose-Sparing Methodologies, Patient and Medical Personnel Protection" covers the basics of operation and radiation delivery for the 3 cardiovascular imaging modalities (x-ray fluoroscopy, x-ray computed tomography, and nuclear scintigraphy). For each modality, it includes the determinants of radiation exposure and techniques to minimize exposure to both patients and to medical personnel.

2018 ACC/HRS/NASCI/SCAI/SCCT Expert Consensus Document on Optimal Use of Ionizing Radiation in Cardiovascular Imaging-Best Practices for Safety and Effectiveness, Part 1: Radiation Physics and Radiation Biology: A Report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways Developed in Collaboration With Mended Hearts.

The stimulus to create this document was the recognition that ionizing radiation-guided cardiovascular procedures are being performed with increasing frequency, leading to greater patient radiation exposure and, potentially, to greater exposure for clinical personnel. Although the clinical benefit of these procedures is substantial, there is concern about the implications of medical radiation exposure. The American College of Cardiology leadership concluded that it is important to provide practitioners with an educational resource that assembles and interprets the current radiation knowledge base relevant to cardiovascular procedures. By applying this knowledge base, cardiovascular practitioners will be able to select procedures optimally, and minimize radiation exposure to patients and to clinical personnel. Optimal Use of Ionizing Radiation in Cardiovascular Imaging: Best Practices for Safety and Effectiveness is a comprehensive overview of ionizing radiation use in cardiovascular procedures and is published online. To provide the most value to our members, we divided the print version of this document into 2 focused parts. Part I: Radiation Physics and Radiation Biology addresses the issue of medical radiation exposure, the basics of radiation physics and dosimetry, and the basics of radiation biology and radiation-induced adverse effects. Part II: Radiological Equipment Operation, Dose-Sparing Methodologies, Patient and Medical Personnel Protection covers the basics of operation and radiation delivery for the 3 cardiovascular imaging modalities (x-ray fluoroscopy, x-ray computed tomography, and nuclear scintigraphy) and will be published in the next issue of the Journal.

Depression and long-term prognostic outcomes following peripheral endovascular interventions in the VA Healthcare System.

The association between depression and peripheral artery disease (PAD) outcomes remains widely understudied. In patients with PAD undergoing a peripheral vascular intervention (PVI) who have a recent diagnosis of depression, it is unknown what their long-term outcomes are and what factors may mediate an adverse risk. We therefore studied 797 consecutive patients undergoing PVI across 33 Veterans Affairs (VA) centers. Depression and outcomes were documented from patients' medical records. Outcomes included: (1) all-cause death; (2) non-fatal cardiovascular events (myocardial infarction, stroke); and (3) PAD-related events (including repeat PVI or amputation). Cox proportional hazards frailty models were constructed, adjusting for age. Additional covariates were selected if they resulted in at least 5% change in the age-adjusted hazard ratio (HR) for depression on outcomes. Overall, 265 (33%) patients had a diagnosis of depression. After a median follow-up of 955 days (range 1-6.25 years), 52 (6.5%) patients died, 30 (3.8%) experienced non-fatal cardiovascular events, and 176 (22.1%) had PAD-related events. Compared to patients without depression, depressed patients had higher rates of non-fatal cardiovascular events (6.4% vs 2.4%, p-value 0.0055). No differences for the other outcomes were noted. Higher risk for non-fatal cardiovascular events persisted after adjustment for age (HR 1.6, 95% CI 1.05-2.47). The only additional covariate that met our selection criteria was hypertension. After adjusting for hypertension, the association between depression and non-fatal cardiovascular outcomes attenuated (HR 1.53, 95% CI 0.99-2.35). In conclusion, a diagnosis of depression in veterans undergoing PVI was associated with increased risk of non-fatal cardiovascular events, mediated by age and hypertension.

Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements.

OBJECTIVE: The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible. METHODS: Under the auspices of the U.S. Food and Drug Administration's Medical Device Epidemiology Network initiative-and its PASSION (Predictable and Sustainable Implementation of the National Registries) program, in conjunction with other efforts to align clinical data standards-the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup was convened. RAPID is a collaborative, multidisciplinary effort to develop a consensus lexicon and to promote interoperability across clinical care, clinical trials, and national and international registries of PVI. RESULTS: The current manuscript presents the initial work from RAPID to standardize clinical data elements and definitions, to establish a framework within electronic health records and health information technology procedural reporting systems, and to implement an informatics-based approach to promote the conduct of pragmatic clinical trials and registry efforts in PVI. CONCLUSIONS: Ultimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators.

Registry Assessment of Peripheral Interventional Devices (RAPID)　- Registry Assessment of Peripheral Interventional Devices Core Data Elements.

BACKGROUND: The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible.Methods and Results:Under the auspices of the U.S. Food and Drug Administration's Medical Device Epidemiology Network initiative-and its PASSION (Predictable and Sustainable Implementation of the National Registries) program, in conjunction with other efforts to align clinical data standards-the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup was convened. RAPID is a collaborative, multidisciplinary effort to develop a consensus lexicon and to promote interoperability across clinical care, clinical trials, and national and international registries of PVI. The current manuscript presents the initial work from RAPID to standardize clinical data elements and definitions, to establish a framework within electronic health records and health information technology procedural reporting systems, and to implement an informatics-based approach to promote the conduct of pragmatic clinical trials and registry efforts in PVI. CONCLUSIONS: Ultimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators.

Delay from Diagnosis to Surgery in Transferred Type A Aortic Dissection.

OBJECTIVES: The purpose of this research is to analyze factors associated with delays to surgical management of Type A acute aortic dissection patients. METHODS: Time from diagnosis to surgery and associated factors were evaluated in 1880 surgically managed Type A dissection patients enrolled in the International Registry of Acute Aortic Dissection. RESULTS: The majority of patients were transferred (75.7% vs 24.3%). Patients who were transferred had a median delay from diagnosis to surgery of 4.0 hours (interquartile range 2.5-7.2 hours), compared with 2.3 hours (interquartile range 1.1-4.2 hours; P < .001) in nontransferred patients. Among patients who were transferred, those with worst-ever, posterior, or tearing chest pain those with severe complications, and those receiving transthoracic echocardiogram prior to a transesophageal echocardiogram or as the only echocardiogram were treated more quickly. Those undergoing magnetic resonance imaging, or who had prior cardiac surgery, had longer delays to surgery. Among nontransferred patients, those with coma were treated more quickly. In both groups, patients presenting with emergent conditions such as cardiac tamponade, hypotension, or shock had more rapid treatment. Among transferred patients, surviving patients had longer delays (4.1 [2.6-7.8] hours vs 3.3 [2.0-6.0] hours, P = .001). Overall mortality did not differ between patients who were transferred vs not (19.3% vs 21.1%, P = .416). CONCLUSION: Simply being transferred added significantly to the delay to surgery for Type A acute aortic dissection patients, but a number of factors affected its extent. Overall, signs and symptoms leading to a definitive diagnosis or indicating immediate life threat reduced time to surgery, while factors suggesting other diagnoses correlated with delays.

Comparative Outcomes After Percutaneous Coronary Intervention Among Black and White Patients Treated at US Veterans Affairs Hospitals.

Importance: Current comparative outcomes among black and white patients treated with percutaneous coronary intervention (PCI) in the Veterans Affairs (VA) health system are not known. Objective: To compare outcomes between black and white patients undergoing PCI in the VA health system. Design, Setting, and Participants: This study compared black and white patients who underwent PCI between October 1, 2007, and September 30, 2013, at 63 VA hospitals using data recorded in the VA Clinical Assessment, Reporting, and Tracking System for Cardiac Catheterization Laboratories (CART-CL) program. A generalized linear mixed model with a random intercept for site assessed the relative difference in odds of outcomes between black and white patients. The setting was integrated institutionalized hospital care. Excluded were all patients of other races or those with multiple listed races and those with missing data regarding race or the diagnostic cardiac catheterization. The dates of analysis were January 7, 2016, to April 17, 2017. Exposure: Percutaneous coronary intervention at a VA hospital. Main Outcomes and Measures: The primary outcome was 1-year mortality. Secondary outcomes were 30-day all-cause readmission rates, 30-day acute kidney injury, 30-day blood transfusion, and 1-year readmission rates for myocardial infarction. In addition, variations in procedural and postprocedural care were examined, including the use of intravascular ultrasound, optical coherence tomography, fractional flow reserve measurements, bare-metal stents, postprocedural medications, and radial access. Results: A total of 42 391 patients (13.3% black and 98.4% male; mean [SD] age, 65.2 [9.1] years) satisfied the inclusion and exclusion criteria. In unadjusted analyses, black patients had higher rates of 1-year mortality (7.1% vs 5.9%, P < .001) as well as secondary outcomes of 30-day acute kidney injury (20.8% vs 13.8%, P < .001), 30-day blood transfusion (3.4% vs 2.7%, P < .01), and 1-year readmission rates for myocardial infarction (3.3% vs 2.7%, P = .01) compared with white patients. After adjustment for demographics, comorbidities, and procedural characteristics, odds for 1-year mortality (odds ratio, 1.04; 95% CI, 0.90-1.19) were not different between black and white patients. There were also no differences in secondary outcomes with the exception of a higher rate of adjusted 30-day acute kidney injury (odds ratio, 1.22; 95% CI, 1.10-1.36). Conclusions and Relevance: While black patients had a higher rate of mortality than white patients in unadjusted analyses, race was not independently associated with 1-year mortality among patients undergoing PCI in VA hospitals.

Contemporary Incidence, Management, and Long-Term Outcomes of Percutaneous Coronary Interventions for Chronic Coronary Artery Total Occlusions: Insights From the VA CART Program.

OBJECTIVES: The aim of this study was to describe the contemporary incidence of chronic total occlusions (CTOs) and the success rates of CTO percutaneous coronary intervention (PCI), as well as the complications and long-term outcomes of these patients. BACKGROUND: The contemporary prevalence and management of coronary CTOs is understudied. METHODS: Consecutive veterans undergoing coronary angiography at 79 Veterans Affairs sites between 2007 and 2013 were examined. Detailed baseline clinical, angiographic, and follow-up outcomes were evaluated using national data from the Veterans Affairs Clinical Assessment Reporting and Tracking program. RESULTS: Among 111,273 patients with obstructive coronary artery disease, 29,399 (26.4%) had ≥1 CTO, most commonly in the right coronary artery distribution (n = 18,986 [64.6%]). Elective CTO PCI was attempted in 2,394 patients (8.1%), with a procedural success rate of 79.7%. The odds of CTO PCI success increased over the years of the study (odds ratio: 1.08; 95% confidence interval [CI]: 1.01 to 1.16; p = 0.03). Compared with failed CTO PCI, successful CTO PCI was associated with a decreased adjusted risk for mortality (hazard ratio: 0.67; 95% CI: 0.47 to 0.95; p = 0.02) and coronary artery bypass graft surgery (hazard ratio: 0.14; 95% CI: 0.08 to 0.24; p < 0.01) at 2 years but no significant change in the risk for hospitalization for myocardial infarction (hazard ratio: 0.89; 95% CI: 0.58 to 1.36; p = 0.58). CONCLUSIONS: Approximately 1 in 4 patients with obstructive coronary artery disease on coronary angiography had CTOs. Among patients who went on to elective CTO PCI, the success rate was 79.7%. Compared with failed CTO PCI, successful CTO PCI was associated with a decreased risk for mortality as well as a decreased need for subsequent coronary artery bypass graft surgery.