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.

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.

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.

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.

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.

Effect of Chronic Kidney Disease on Mortality in Patients Who Underwent Lower Extremity Peripheral Vascular Intervention.

It is known that chronic kidney disease (CKD) is associated with increased postoperative morbidity and mortality in patients with peripheral artery disease who underwent lower extremity surgical revascularization; however, outcomes after peripheral vascular intervention (PVI) are less well established. This study sought to determine the impact of CKD on adverse outcomes in patients with peripheral artery disease who underwent PVI. Using data from the Veteran Affairs Clinical Assessment, Reporting, and Tracking System Program, we identified a cohort of 755 patients who underwent lower extremity PVI from June 2005 to August 2010 at 33 sites. The outcomes of interest were mortality, progression to dialysis, myocardial infarction, limb amputation, and stroke. Kaplan-Meier survival analysis and Cox proportional hazard frailty models assessed the association between CKD and adverse outcomes. Of the patients who underwent lower extremity PVI, 201 patients (27%) had CKD. The presence of CKD was associated with decreased survival (5-year survival probability of CKD compared with non-CKD: 49.9% [41.6% to 59.9%] vs 80.1% [76.2% to 84.1]), which persisted after risk adjustment (HR 1.57; 95% confidence interval 1.13 to 2.19). In addition, there was a significant association between CKD and progression to dialysis (HR 6.62; 95% confidence interval 2.25 to 19.43). In contrast, there was no association between CKD and re-hospitalization for myocardial infarction, limb amputation, or stroke. In conclusion, CKD is present in 1 of 4 patients who underwent PVI and is associated with increased risk of mortality and progression to dialysis.

Chronic Kidney Disease Progression and Cardiovascular Outcomes Following Cardiac Catheterization-A Population-Controlled Study.

BACKGROUND: Studies of kidney disease associated with cardiac catheterization typically rely on billing records rather than laboratory data. We examined the associations between percutaneous coronary interventions, acute kidney injury, and chronic kidney disease progression using comprehensive Veterans Affairs clinical and laboratory databases. METHODS AND RESULTS: Patients undergoing percutaneous coronary interventions between 2005 and 2010 (N=24 405) were identified in the Veterans Affairs Clinical Assessment, Reporting, and Tracking registry and examined for associated acute kidney injury and chronic kidney disease development or progression relative to 24 405 matched population controls. Secondary outcomes analyzed included dialysis, acute myocardial infarction, and mortality. The incidence of chronic kidney disease progression following percutaneous coronary interventions complicated by acute kidney injury, following uncomplicated coronary interventions, and in matched controls were 28.66, 11.15, and 6.81 per 100 person-years, respectively. Percutaneous coronary intervention also increased the likelihood of chronic kidney disease progression in both the presence and absence of acute injury relative to controls in adjusted analyses (hazard ratio [HR], 5.02 [95% CI, 4.68-5.39]; and HR, 1.76 [95% CI, 1.70-1.86]). Among patients with estimated glomerular filtration rate <60 mL/min per 1.73 m2, acute kidney injury increased the likelihood of disease progression by 8-fold. Similar results were observed for all secondary outcomes. CONCLUSIONS: Acute kidney injury following percutaneous coronary intervention was associated with increased chronic kidney disease development and progression and mortality.

Impact of Retrograde Arch Extension in Acute Type B Aortic Dissection on Management and Outcomes.

BACKGROUND: Optimal management of acute type B aortic dissection with retrograde arch extension is controversial. The effect of retrograde arch extension on operative and long-term mortality has not been studied and is not incorporated into clinical treatment pathways. METHODS: The International Registry of Acute Aortic Dissection was queried for all patients presenting with acute type B dissection and an identifiable primary intimal tear. Outcomes were stratified according to management for patients with and without retrograde arch extension. Kaplan-Meier survival curves were constructed. RESULTS: Between 1996 and 2014, 404 patients (mean age, 63.3 ± 13.9 years) were identified. Retrograde arch extension existed in 67 patients (16.5%). No difference in complicated presentation was noted (36.8% vs 31.7%, p = 0.46), as defined by limb or organ malperfusion, coma, rupture, and shock. Patients with or without retrograde arch extension received similar treatment, with medical management in 53.7% vs 56.5% (p = 0.68), endovascular treatment in 32.8% vs 31.1% (p = 0.78), open operation in 11.9% vs 9.5% (p = 0.54), or hybrid approach in 1.5% vs 3.0% (p = 0.70), respectively. The in-hospital mortality rate was similar for patients with (10.7%) and without (10.4%) retrograde arch extension (p = 0.96), and 5-year survival was also similar at 78.3% and 77.8%, respectively (p = 0.27). CONCLUSIONS: The incidence of retrograde arch dissection involves approximately 16% of patients with acute type B dissection. In the International Registry of Acute Aortic Dissection, this entity seems not to affect management strategy or early and late death.

Use of Contraindicated Antiplatelet Medications in the Setting of Percutaneous Coronary Intervention: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

BACKGROUND: Several antiplatelet medications used during and after percutaneous coronary intervention (PCI) are contraindicated for specific patient groups. A broad assessment of contraindicated medication use and associated clinical outcomes is not well described. METHODS AND RESULTS: Using national Veterans Affairs Clinical Assessment, Reporting, and Tracking Program data for all PCI between 2007 and 2013, we evaluated patients with contraindications to commonly used antiplatelet medications during and after PCI, defined in accordance with package inserts. Adjusted association between contraindicated medication use and outcomes of periprocedural bleeding and 30-day mortality were assessed using Cox proportional hazards with inverse probability weighting. Among 64 294 patients undergoing PCI, 11 315(17.6%) had a contraindication to a common antiplatelet medication and 737 (6.5%) of these patients received a contraindicated medication. In unadjusted analyses, any contraindicated medication use was associated with both increased bleeding and 30-day mortality. In adjusted models, contraindicated abciximab use in patients with thrombocytopenia (hazard ratio, 2.23; 95% confidence interval, 1.58-3.16) and in patients with a previous stroke (hazard ratio, 1.93; 95% confidence interval, 1.37-2.71) remained significantly associated with increased bleeding. Contraindicated abciximab use was not significantly associated with 30-day mortality in adjusted models. Use of eptifibatide in dialysis patients was not significantly associated with an increased risk of bleeding or mortality. CONCLUSIONS: In this national cohort, ≈18% of patients undergoing PCI had contraindications to common antiplatelet medications. Approximately 6% of those patients received a contraindicated medication with attendant bleeding risk, although this did not translate into significantly higher risk of 30-day mortality. Continued efforts to reduce contraindicated medication use may help avoid periprocedural complications.

Comparative Effectiveness of Carotid Artery Stenting Versus Carotid Endarterectomy Among Medicare Beneficiaries.

BACKGROUND: Effectiveness of carotid artery stenting (CAS) relative to carotid endarterectomy (CEA) among Medicare patients has not been established. We compared effectiveness of CAS versus CEA among Medicare beneficiaries. METHODS AND RESULTS: We linked Medicare data (2000-2009) to the Society for Vascular Surgery's Vascular Registry (2005-2008) and the National Cardiovascular Data Registry's (NCDR) Carotid Artery Revascularization and Endarterectomy Registry (2006-2008/2009). Medicare patients were followed up from procedure date until death, stroke/transient ischemic attack, periprocedural myocardial infarction, or a composite end point for these outcomes. We derived high-dimensional propensity scores using registry and Medicare data to control for patient factors and adjusted for provider factors in a Cox regression model comparing CAS with CEA. Among 5254 Society for Vascular Surgery's Vascular Registry (1999 CAS; 3255 CEA) and 4055 Carotid Artery Revascularization and Endarterectomy Registry (2824 CAS; 1231 CEA) Medicare patients, CAS patients had a higher comorbidity burden and were more likely to be at high surgical risk (Society for Vascular Surgery's Vascular Registry: 96.7% versus 44.5%; Carotid Artery Revascularization and Endarterectomy Registry: 71.3% versus 44.7%). Unadjusted outcome risks were higher for CAS. Mortality risks remained elevated for CAS after adjusting for patient-level factors (hazard ratio, 1.24; 95% confidence interval, 1.06-1.46). After further adjustment for provider factors, differences between CAS and CEA were attenuated or no longer present (hazard ratio for mortality, 1.13; 95% confidence interval, 0.94-1.37). Performance was comparable across subgroups defined by sex and degree of carotid stenosis, but there was a nonsignificant trend suggesting a higher risk of adverse outcomes in older (>80) and symptomatic patients undergoing CAS. CONCLUSIONS: Outcomes after CAS and CEA among Medicare beneficiaries were comparable after adjusting for both patient- and provider-level factors.

The Contemporary Safety and Effectiveness of Lower Extremity Bypass Surgery and Peripheral Endovascular Interventions in the Treatment of Symptomatic Peripheral Arterial Disease.

BACKGROUND: Treatment for symptomatic peripheral artery disease includes lower extremity bypass surgery (LEB) and peripheral endovascular interventions (PVIs); however, limited comparative effectiveness data exist between the 2 therapies. We assessed the safety and effectiveness of LEB and PVI in patients with symptomatic claudication and critical limb ischemia. METHODS AND RESULTS: In a community-based clinical registry at 2 large integrated healthcare delivery systems, we compared 883 patients undergoing PVI and 975 patients undergoing LEB between January 1, 2005 and December 31, 2011. Rates of target lesion revascularization were greater for PVI than for LEB in patients presenting with claudication (12.3±2.7% and 19.0±3.5% at 1 and 3 years versus 5.2±2.4% and 8.3±3.1%, log-rank P<0.001) and critical limb ischemia (19.1±4.8% and 31.6±6.3% at 1 and 3 years versus 10.8±2.5% and 16.0±3.2%, log-rank P<0.001). However, in comparison with PVI, LEB was associated with increased rates of complications up to 30 days following the procedure (37.1% versus 11.9%, P<0.001). There were no differences in amputation rates between the 2 groups. Findings remained consistent in sensitivity analyses by using propensity methods to account for treatment selection. CONCLUSIONS: In patients with symptomatic peripheral artery disease, in comparison with LEB, PVI was associated with fewer 30-day procedural complications, higher revascularization rates at 1 and 3 years, and no difference in subsequent amputations.