Outcomes of carotid revascularization stratified by procedure in patients with an estimated glomerular filtration rate of <30 and dialysis patients.

OBJECTIVE: Renal failure is a predictor of adverse outcomes in carotid revascularization. There has been debate regarding the benefit of revascularization in patients with severe chronic kidney disease or on dialysis. METHODS: Patients in the Vascular Quality Initiative undergoing transcarotid artery revascularization (TCAR), transfemoral carotid artery stenting (tfCAS), or CEA between 2016 and 2023 with an estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73 m2 or on dialysis were included. Patients were divided into cohorts based on procedure. Additional analyses were performed for patients on dialysis only and by symptomatology. Primary outcomes were perioperative stroke/death/myocardial infarction (MI) (SDM). Secondary outcomes included perioperative death, stroke, MI, cranial nerve injury, and stroke/death. Inverse probability of treatment weighting was performed based on treatment assignment to TCAR, tfCAS, and CEA patients and adjusted for demographics, comorbidities, and preoperative symptoms. The χ2 test and multivariable logistic regression analysis were used to evaluate the association of procedure with perioperative outcomes in the weighted cohort. Five-year survival was evaluated using Kaplan-Meier and weighted Cox regression. RESULTS: In the weighted cohort, 13,851 patients with an eGFR of <30 (2506 on dialysis) underwent TCAR (3639; 704 on dialysis), tfCAS (1975; 393 on dialysis), or CEA (8237; 1409 on dialysis) during the study period. Compared with TCAR, CEA had higher odds of SDM (2.8% vs 3.6%; adjusted odds ratio [aOR], 1.27; 95% confidence interval [CI], 1.00-1.61; P = .049), and MI (0.7% vs 1.5%; aOR, 2.00; 95% CI, 1.31-3.05; P = .001). Compared with TCAR, rates of SDM (2.8% vs 5.8%), stroke (1.2% vs 2.6%), and death (0.9% vs 2.4%) were all higher for tfCAS. In asymptomatic patients CEA patients had higher odds of MI (0.7% vs 1.3%; aOR, 1.85; 95% CI, 1.15-2.97; P = .011) and cranial nerve injury (0.3% vs 1.9%; aOR, 7.23; 95% CI, 3.28-15.9; P < .001). Like in the primary analysis, asymptomatic tfCAS patients demonstrated higher odds of death and stroke/death. Symptomatic CEA patients demonstrated no difference in stroke, death, or stroke/death. Although tfCAS patients demonstrated higher odds of death, stroke, MI, stroke/death, and SDM. In both groups, the 5-year survival was similar for TCAR and CEA (eGFR <30, 75.1% vs 74.2%; aHR, 1.06; P = .3) and lower for tfCAS (eGFR <30, 75.1% vs 70.4%; aHR, 1.44; P < .001). CONCLUSIONS: CEA and TCAR had similar odds of stroke and death and are both a reasonable choice in this population; however, TCAR may be better in patients with an increased risk of MI. Additionally, tfCAS patients were more likely to have worse outcomes after weighting for symptom status. Finally, although patients with a reduced eGFR have worse outcomes than their healthy peers, this analysis shows that the majority of patients survive long enough to benefit from the potential stroke risk reduction provided by all revascularization procedures.

Surgery or endovascular therapy for patients with chronic limb-threatening ischemia requiring infrapopliteal interventions.

OBJECTIVE: The recent publication of randomized trials comparing open bypass surgery to endovascular therapy in patients with chronic limb-threatening ischemia, namely, Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) and Bypass versus Angioplasty in Severe Ischaemia of the Leg-2 (BASIL-2), has resulted in potentially contradictory findings. The trials differed significantly with respect to anatomical disease patterns and primary end points. We performed an analysis of patients in BEST-CLI with significant infrapopliteal disease undergoing open tibial bypass or endovascular tibial interventions to formulate a relevant comparator with the outcomes reported from BASIL-2. METHODS: The study population consisted of patients in BEST-CLI with adequate single segment saphenous vein conduit randomized to open bypass or endovascular intervention (cohort 1) who additionally had significant infrapopliteal disease and underwent tibial level intervention. The primary outcome was major adverse limb event (MALE) or all-cause death. MALE included any major limb amputation or major reintervention. Outcomes were evaluated using Cox proportional regression models. RESULTS: The analyzed subgroup included a total of 665 patients with 326 in the open tibial bypass group and 339 in the tibial endovascular intervention group. The primary outcome of MALE or all-cause death at 3 years was significantly lower in the surgical group at 48.5% compared with 56.7% in the endovascular group (P = .0018). Mortality was similar between groups (35.5% open vs 35.8% endovascular; P = .94), whereas MALE events were lower in the surgical group (23.3% vs 35.0%; P<.0001). This difference included a lower rate of major reinterventions in the surgical group (10.9%) compared with the endovascular group (20.2%; P = .0006). Freedom from above ankle amputation or all-cause death was similar between treatment arms at 43.6% in the surgical group compared with 45.3% the endovascular group (P = .30); however, there were fewer above ankle amputations in the surgical group (13.5%) compared with the endovascular group (19.3%; P = .0205). Perioperative (30-day) death rates were similar between treatment groups (2.5% open vs 2.4% endovascular; P = .93), as was 30-day major adverse cardiovascular events (5.3% open vs 2.7% endovascular; P = .12). CONCLUSIONS: Among patients with suitable single segment great saphenous vein who underwent infrapopliteal revascularization for chronic limb-threatening ischemia, open bypass surgery was associated with a lower incidence of MALE or death and fewer major amputation compared with endovascular intervention. Amputation-free survival was similar between the groups. Further investigations into differences in comorbidities, anatomical extent, and lesion complexity are needed to explain differences between the BEST-CLI and BASIL-2 reported outcomes.

Seven years of the transcarotid artery revascularization surveillance project, comparison to transfemoral stenting and endarterectomy.

OBJECTIVE: This study utilizes the latest data from the Vascular Quality Initiative (VQI), which now encompasses over 50,000 transcarotid artery revascularization (TCAR) procedures, to offer a sizeable dataset for comparing the effectiveness and safety of TCAR, transfemoral carotid artery stenting (tfCAS), and carotid endarterectomy (CEA). Given this substantial dataset, we are now able to compare outcomes overall and stratified by symptom status across revascularization techniques. METHODS: Utilizing VQI data from September 2016 to August 2023, we conducted a risk-adjusted analysis by applying inverse probability of treatment weighting to compare in-hospital outcomes between TCAR vs tfCAS, CEA vs tfCAS, and TCAR vs CEA. Our primary outcome measure was in-hospital stroke/death. Secondary outcomes included myocardial infarction and cranial nerve injury. RESULTS: A total of 50,068 patients underwent TCAR, 25,361 patients underwent tfCAS, and 122,737 patients underwent CEA. TCAR patients were older, more likely to have coronary artery disease, chronic kidney disease, and undergo coronary artery bypass grafting/percutaneous coronary intervention as well as prior contralateral CEA/CAS compared with both CEA and tfCAS. TfCAS had higher odds of stroke/death when compared with TCAR (2.9% vs 1.6%; adjusted odds ratio [aOR], 1.84; 95% confidence interval [CI], 1.65-2.06; P < .001) and CEA (2.9% vs 1.3%; aOR, 2.21; 95% CI, 2.01-2.43; P < .001). CEA had slightly lower odds of stroke/death compared with TCAR (1.3% vs 1.6%; aOR, 0.83; 95% CI, 0.76-0.91; P < .001). TfCAS had lower odds of cranial nerve injury compared with TCAR (0.0% vs 0.3%; aOR, 0.00; 95% CI, 0.00-0.00; P < .001) and CEA (0.0% vs 2.3%; aOR, 0.00; 95% CI, 0.0-0.0; P < .001) as well as lower odds of myocardial infarction compared with CEA (0.4% vs 0.6%; aOR, 0.67; 95% CI, 0.54-0.84; P < .001). CEA compared with TCAR had higher odds of myocardial infarction (0.6% vs 0.5%; aOR, 1.31; 95% CI, 1.13-1.54; P < .001) and cranial nerve injury (2.3% vs 0.3%; aOR, 9.42; 95% CI, 7.78-11.4; P < .001). CONCLUSIONS: Although tfCAS may be beneficial for select patients, the lower stroke/death rates associated with CEA and TCAR are preferred. When deciding between CEA and TCAR, it is important to weigh additional procedural factors and outcomes such as myocardial infarction and cranial nerve injury, particularly when stroke/death rates are similar. Additionally, evaluating subgroups that may benefit from one procedure over another is essential for informed decision-making and enhanced patient care in the treatment of carotid stenosis.

Association of stroke or death with severity of carotid lesion calcification in patients undergoing carotid artery stenting.

OBJECTIVE: Carotid artery stenting (CAS) for heavily calcified lesions is controversial due to concern for stent failure and increased perioperative stroke risk. However, the degree to which calcification affects outcomes is poorly understood, particularly in transcarotid artery revascularization (TCAR). With the precipitous increase in TCAR use and its expansion to standard surgical-risk patients, we aimed to determine the impact of lesion calcification on CAS outcomes to ensure its safe and appropriate use. METHODS: We identified patients in the Vascular Quality Initiative who underwent first-time transfemoral CAS (tfCAS) and TCAR between 2016 and 2021. Patients were stratified into groups based on degree of lesion calcification: no calcification, 1% to 50% calcification, 51% to 99% calcification, and 100% circumferential calcification or intraluminal protrusion. Outcomes included in-hospital and 1-year composite stroke/death, as well as individual stroke, death, and myocardial infarction outcomes. Logistic regression was used to evaluate associations between degree of calcification and these outcomes. RESULTS: Among 21,860 patients undergoing CAS, 28% patients had no calcification, 34% had 1% to 50% calcification, 35% had 51% to 99% calcification, and 3% had 100% circumferential calcification/protrusion. Patients with 51% to 99% and circumferential calcification/protrusion had higher odds of in-hospital stroke/death (odds ratio [OR], 1.3; 95% confidence interval [CI], 1.02-1.6; P = .034; OR, 1.9; 95% CI, 1.1-2.9; P = .004, respectively) compared with those with no calcification. Circumferential calcification was also associated with increased risk for in-hospital myocardial infarction (OR, 3.5; 95% CI, 1.5-8.0; P = .003). In tfCAS patients, only circumferential calcification/protrusion was associated with higher in-hospital stroke/death odds (OR, 2.0; 95% CI, 1.2-3.4; P = .013), whereas for TCAR patients, 51% to 99% calcification was associated with increased odds of in-hospital stroke/death (OR, 1.5; 95% CI, 1.1-2.2; P = .025). At 1 year, circumferential calcification/protrusion was associated with higher odds of ipsilateral stroke/death (12.4% vs 6.6%; hazard ratio, 1.64; P = .002). CONCLUSIONS: Among patients undergoing CAS, there is an increased risk of in-hospital stroke/death for lesions with >50% calcification or circumferential/protruding plaques. Increasing severity of carotid lesion calcification is a significant risk factor for stroke/death in patients undergoing CAS, regardless of approach.

Risk of Stroke, Death, and Myocardial Infarction Following Transcarotid Artery Revascularization vs Carotid Endarterectomy in Patients With Standard Surgical Risk.

Importance: Carotid artery stenting has been limited to use in patients with high surgical risk; outcomes in patients with standard surgical risk are not well known. Objective: To compare stroke, death, and myocardial infarction outcomes following transcarotid artery revascularization vs carotid endarterectomy in patients with standard surgical risk. Design, Setting, and Participants: This retrospective propensity-matched cohort study was conducted from August 2016 to August 2019 with follow-up until August 31, 2020, using data from the multicenter Vascular Quality Initiative Carotid Artery Stent and Carotid Endarterectomy registries. Patients with standard surgical risk, defined as those lacking Medicare-defined high medical or surgical risk characteristics and undergoing transcarotid artery revascularization (n = 2962) or carotid endarterectomy (n = 35 063) for atherosclerotic carotid disease. In total, 760 patients were excluded for treatment of multiple lesions or in conjunction with other procedures. Exposures: Transcarotid artery revascularization vs carotid endarterectomy. Main Outcomes and Measures: The primary outcome was a composite end point of 30-day stroke, death, or myocardial infarction or 1-year ipsilateral stroke. Results: After 1:3 matching, 2962 patients undergoing transcarotid artery revascularization (mean [SD] age, 70.4 [6.9] years; 1910 [64.5%] male) and 8886 undergoing endarterectomy (mean [SD] age, 70.0 [6.5] years; 5777 [65.0%] male) were identified. There was no statistically significant difference in the risk of the primary composite end point between the 2 cohorts (transcarotid 3.0% vs endarterectomy 2.6%; absolute difference, 0.40% [95% CI, -0.43% to 1.24%]; relative risk [RR], 1.14 [95% CI, 0.87 to 1.50]; P = .34). Transcarotid artery revascularization was associated with a higher risk of 1-year ipsilateral stroke (1.6% vs 1.1%; absolute difference, 0.52% [95% CI, 0.03 to 1.08]; RR, 1.49 [95% CI, 1.05 to 2.11%]; P = .02) but no difference in 1-year all-cause mortality (2.6% vs 2.5%; absolute difference, -0.13% [95% CI, -0.18% to 0.33%]; RR, 1.04 [95% CI, 0.78 to 1.39]; P = .67). Conclusions and Relevance: In this study, the risk of 30-day stroke, death, or myocardial infarction or 1-year ipsilateral stroke was similar in patients undergoing transcarotid artery revascularization compared with those undergoing endarterectomy for carotid stenosis.

Lockdown, Earnings Losses and Household Asset Buffers in Europe.

Measures taken to contain the spread of COVID-19 affected some workers' capability to work and hence earning more than others. The initial impact may have been mitigated, for instance by relying on savings and assets, but access to these buffers likely varied within and across countries. In this article we estimate COVID-19 potential earnings losses using the Lockdown Working Ability Index and relate this to households' savings and assets observed in the Eurosystem Household Finance and Consumption Survey. We find that, without government support, households in the Euro Area could only offset on average half of their losses by relying on liquid assets and almost half would deplete their savings in doing so, although there is significant cross-country variation. When considering the effect of income support policies, liquid assets cover on average 65 percent of the remaining losses and still 20 percent would exhaust their liquid assets on average in the Euro Area.

Outcomes after transcarotid artery revascularization stratified by preprocedural symptom status.

OBJECTIVE: Previous studies on carotid endarterectomy and transfemoral carotid artery stenting demonstrated that perioperative outcomes differed according to preoperative neurologic injury severity, but this has not been assessed in transcarotid artery revascularization (TCAR). In this study, we examined contemporary perioperative outcomes in patients who underwent TCAR stratified by specific preprocedural symptom status. METHODS: Patients who underwent TCAR between 2016 and 2021 in the Vascular Quality Initiative were included. We stratified patients into the following groups based on preprocedural symptoms: asymptomatic, recent (symptoms occurring <180 days before TCAR) ocular transient ischemic attack (TIA), recent hemispheric TIA, recent stroke, or formerly symptomatic (symptoms occurring >180 days before TCAR). First, we used trend tests to assess outcomes in asymptomatic patients versus those with an increasing severity of recent neurologic injury (recent ocular TIA vs recent hemispheric TIA vs recent stroke). Then, we compared outcomes between asymptomatic and formerly symptomatic patients. Our primary outcome was in-hospital stroke/death rates. Multivariable logistic regression was used to adjust for demographics and comorbidities across groups. RESULTS: We identified 18,477 patients undergoing TCAR, of whom 62.0% were asymptomatic, 3.2% had a recent ocular TIA, 7.6a % had recent hemispheric TIA, 18.0% had a recent stroke, and 9.2% were formerly symptomatic. In patients with recent symptoms, we observed higher rates of stroke/death with increasing neurologic injury severity: asymptomatic 1.1% versus recent ocular TIA 0.8% versus recent hemispheric TIA 2.1% versus recent stroke 3.1% (Ptrend < .01). In formerly symptomatic patients, the rate of stroke/death was higher compared with asymptomatic patients, but this difference was not statistically significant (1.7% vs 1.1%; P = .06). After risk adjustment, compared with asymptomatic patients, there was a higher odds of stroke/death in patients with a recent stroke (odds ratio [OR], 2.8; 95% confidence interval [CI], 2.1-3.7; P < .01), a recent hemispheric TIA (OR, 2.0; 95% CI, 1.3-3.0; P < .01), and former symptoms (OR, 1.6; 95% CI, 1.1-2.5; P = .02), but there was no difference in stroke/death rates in patients with a recent ocular TIA (OR, 0.9; 95% CI, 0.4-2.2; P = .78). CONCLUSIONS: After TCAR, compared with asymptomatic status, a recent stroke and a recent hemispheric TIA were associated with higher stroke/death rates, whereas a recent ocular TIA was associated with similar stroke/death rates. In addition, a formerly symptomatic status was associated with higher stroke/death rates compared with an asymptomatic status. Overall, our findings suggest that classifying patients undergoing TCAR as symptomatic versus asymptomatic may be an oversimplification and that patients' specific preoperative neurologic symptoms should instead be used in risk assessment and outcome reporting for TCAR.

A specialized multi-disciplinary care program for children with sepsis and multiple organ dysfunction-associated immune dysregulation.

The complex physiology and medical requirements of children with sepsis and multiple organ dysfunction syndrome (MODS) challenge traditional care coordination models. While the involvement of multiple clinical subspecialty services is often necessary to support different care processes and individual organ system dysfunctions, it can also delay the diagnostic process, monitoring, and treatment. The logistics of coordinating with many specialty providers for critically ill patients are challenging and time consuming, and often can result in fragmented communication. To address these and other related issues, we developed a new multi-disciplinary consult service focused on streamlining diagnostics, management, and communication for patients with sepsis and MODS-associated immune dysregulation. The service, called the Program in Inflammation, Immunity, and the Microbiome (PrIIMe), is now a hospital-wide clinical consult service at our institution caring for a broad group of patients with immune dysregulation, particularly focusing on patients with sepsis and MODS. In this paper, we summarize the development, structure, and function of the program, as well as the initial impact. This information may be helpful to clinicians and healthcare leaders who are developing multi-disciplinary consult services for children with complex care needs, especially those with sepsis and MODS-associated immune dysregulation. IMPACT: The care of children with sepsis and multiple organ dysfunction-associated immune dysregulation requires rapid and flexible involvement of multiple clinical subspecialists that is difficult to achieve without fragmented care and delayed decision making. In this narrative review we describe the development, structure, and function of a multi-disciplinary consult service at a children's hospital dedicated to helping coordinate management and provide continuity of care for patients with sepsis and multiple organ dysfunction-associated immune dysregulation. This information may be helpful to clinicians and healthcare leaders who are developing multi-disciplinary consult services for children with complex care needs, especially those with sepsis and MODS-associated immune dysregulation.

Juvenile Dermatomyositis: New Clues to Diagnosis and Therapy.

PURPOSE OF REVIEW: To identify clues to disease activity and discuss therapy options. RECENT FINDINGS: The diagnostic evaluation includes documenting symmetrical proximal muscle damage by exam and MRI, as well as elevated muscle enzymes-aldolase, creatine phosphokinase, LDH, and SGOT-which often normalize with a longer duration of untreated disease. Ultrasound identifies persistent, occult muscle inflammation. The myositis-specific antibodies (MSA) and myositis-associated antibodies (MAA) are associated with specific disease course variations. Anti-NXP-2 is found in younger children and is associated with calcinosis; anti-TIF-1γ+ juvenile dermatomyositis has a longer disease course. The diagnostic rash-involving the eyelids, hands, knees, face, and upper chest-is the most persistent symptom and is associated with microvascular compromise, reflected by loss of nailfold (periungual) end row capillaries. This loss is associated with decreased bioavailability of oral prednisone; the bioavailability of other orally administered medications should also be considered. At diagnosis, at least 3 days of intravenous methyl prednisolone may help control the HLA-restricted and type 1/2 interferon-driven inflammatory process. The requirement for avoidance of ultraviolet light exposure mandates vitamin D supplementation. SUMMARY: This often chronic illness targets the cardiovascular system; mortality has decreased from 30 to 1-2% with corticosteroids. New serological biomarkers indicate occult inflammation: ↑CXCL-10 predicts a longer disease course. Some biologic therapies appear promising.

Constrained chromatin accessibility in PU.1-mutated agammaglobulinemia patients.

The pioneer transcription factor (TF) PU.1 controls hematopoietic cell fate by decompacting stem cell heterochromatin and allowing nonpioneer TFs to enter otherwise inaccessible genomic sites. PU.1 deficiency fatally arrests lymphopoiesis and myelopoiesis in mice, but human congenital PU.1 disorders have not previously been described. We studied six unrelated agammaglobulinemic patients, each harboring a heterozygous mutation (four de novo, two unphased) of SPI1, the gene encoding PU.1. Affected patients lacked circulating B cells and possessed few conventional dendritic cells. Introducing disease-similar SPI1 mutations into human hematopoietic stem and progenitor cells impaired early in vitro B cell and myeloid cell differentiation. Patient SPI1 mutations encoded destabilized PU.1 proteins unable to nuclear localize or bind target DNA. In PU.1-haploinsufficient pro-B cell lines, euchromatin was less accessible to nonpioneer TFs critical for B cell development, and gene expression patterns associated with the pro- to pre-B cell transition were undermined. Our findings molecularly describe a novel form of agammaglobulinemia and underscore PU.1's critical, dose-dependent role as a hematopoietic euchromatin gatekeeper.

The Two-bag System for Intravenous Fluid Management of Children with Diabetic Ketoacidosis: Experience from a Community-Based Hospital.

Objectives: Intravenous fluid (IVF) administration using the two-bag system compared with the one-bag system in children with diabetic ketoacidosis (DKA) admitted between January 1, 2015 and December 31, 2016. Design: Retrospective cohort study. Setting: Community-based hospital. Results: A total of 109 patients were enrolled with a mean age of 13.24 years. The 2 groups had comparable demographics. Initial laboratory results were similar except for initial PH and Sodium. The two bag system had significantly less number of calls compared to one bag system (25.2 vs 5.2 P = .0001). One bag system had fewer hypoglycemia <60 mg/dl (4 vs 12 P = .049). No statistically significant observations noted in regards to glucose drop rate, number of intravenous fluid bags used, amount of fluid boluses given, hospital stay and Pediatric ICU stay. Conclusions: The two-bag system has less resource utilization and slower blood glucose drop rate, but higher hypoglycemic events.

Association of Adoption of Transcarotid Artery Revascularization With Center-Level Perioperative Outcomes.

Importance: Transcarotid artery revascularization (TCAR) may serve as a safer alternative to carotid endarterectomy (CEA) for certain patients with carotid artery stenosis. Objective: To determine the center-level association of TCAR adoption with overall perioperative outcomes for TCAR and CEA combined at centers performing both procedures. Design, Setting, and Participants: This comparative-effectiveness research was conducted with a difference-in-difference analysis using retrospective data from 2015 to 2019 from the Vascular Quality Initiative registry, a consortium of more than 400 centers in North America. Included patients underwent TCAR or CEA for carotid artery stenosis. Patients who underwent transfemoral carotid stenting were excluded. Data were analyzed from December 2019 through August 2020. Exposures: Center-level adoption of TCAR vs not. Main Outcomes and Measures: The rate of major adverse cardiovascular events (MACE), a composite of in-hospital stroke, myocardial infarction, or death at 30 days, was measured. Results: Among 86 027 patients who underwent revascularization for carotid artery stenosis, 7664 patients (8.9%) underwent TCAR (mean [SD] age, 73.1 [9.6] years; 2788 [36.4%] women; 6938 White patients [90.6%]; and 3741 patients with symptoms [48.8%]) and 78 363 patients (91.1%) underwent CEA (mean [SD] age, 70.6 [9.2] years; 30 928 [39.5%] women; 70 663 White patients [90.2%]; and 37 883 patients with symptoms [48.3%]). The number of centers performing both TCAR and CEA increased from 15 centers in 2015 to 247 centers in 2019, a more than 16-fold increase. The proportion of all carotid procedures that were TCARs increased from 90 of 12 276 (0.7%) in 2015 to 2718 of 15 956 (17.0%) in 2019, a 24-fold increase. Overall, the crude rate of MACE was similar for TCAR and CEA (178 patients [2.3%] after TCAR vs 1842 patients [2.4%] after CEA; P = .91). However, the rate of MACE over time decreased for CEA (406 of 16 404 patients [2.5%] in 2015 vs 189 of 10 097 patients [1.9%] in 2019; P for trend < .001). The rate of MACE over time decreased for TCAR as well, but the change was not statistically significant (4 of 128 patients [3.1%] in 2016 vs 59 of 2718 patients [2.2%] in 2019; P for trend = .07). Difference-in-difference analysis demonstrated that centers that adopted TCAR had a 10% decrease in the likelihood of MACE at 12 months after TCAR adoption vs if those centers had continued to perform CEA alone (odds ratio, 0.90; 95% CI, 0.81-0.99; P = .04). Conclusions and Relevance: This comparative-effectiveness study of a cohort of patients who underwent TCAR or CEA found that availability of TCAR at a hospital was associated with a decrease in the likelihood of perioperative MACE after carotid revascularization.

Incorporating joint pain screening into the pediatric dermatologic examination.

BACKGROUND/OBJECTIVES: Joint manifestations are a feature of many pediatric skin disorders, among them psoriasis, autoimmune and autoinflammatory diseases, hypermobility disorders, and as an adverse effect of certain medications. Identifying joint disease early is important for intervention and prevention of chronic damage. However, pediatric musculoskeletal complaints are common and determining whether symptoms warrant a rheumatology referral for arthritis can be challenging. METHODS: Pediatric dermatologists were surveyed for their comfort in screening for joint disease. Through literature review and interviews with three pediatric rheumatologists, key joints involved in disorders with skin manifestations and arthritis were identified and the essential evaluations were determined. RESULTS: Of 100 surveyed practicing board-certified pediatric dermatologists, 79% did not feel confident in their ability to perform a joint-focused physical examination, a key step in screening for joint disease. A rapid joint examination technique (R-JET) was developed, along with an accompanying three-question survey and body diagram for patient self-report of symptoms. A video demonstration of the R-JET was created as a teaching tool. CONCLUSIONS: Teaching and incorporation of a rapid screening examination for arthritis by pediatric dermatologists has the potential to identify pediatric arthritis earlier, facilitate referral, and reduce the risk of progressive joint disease. These instruments can easily be incorporated into a pediatric dermatology office visit.

Vascular Quality Initiative risk score for 30-day stroke or death following transcarotid artery revascularization.

OBJECTIVE: Transcarotid artery revascularization (TCAR) using a flow-reversal neuroprotection system has gained popularity for the endovascular treatment of carotid artery atherosclerotic disease owing to its lower risk of stroke or death compared with transfemoral carotid artery stenting. However, specific risk factors associated with stroke or death complications after TCAR have yet to be defined. METHODS: All patients undergoing TCAR for the treatment of asymptomatic or symptomatic atherosclerotic carotid disease were identified between September 2016 and September 2019 in the Vascular Quality Initiative TCAR Surveillance Project. Our primary outcome was 30-day stroke or death. We created a risk model for 30-day stroke or death using multivariable fractional polynomials and internally validated the model using bootstrapping. RESULTS: During the study period 7633 patients underwent TCAR, of which 4089 (53.6%) were treated for symptomatic and 3544 (46.4%) for asymptomatic disease. The average age of patients undergoing TCAR was 73.3 ± 9.1 years and 63.7% were male. Stroke or death events within 30 days of the index operation occurred in 153 patients (2.0%). Factors independently associated with a higher odds of 30-day stroke or death included the severity of presenting stroke symptoms (cortical transient ischemic attack, odds ratio [OR], 2.17 [95% confidence interval (CI), 1.21-3.90; P = .009]; stroke, OR, 3.30; 95% CI, 2.25-4.85; P < .001), advancing age (OR, 1.03 per year; 95% CI, 1.01-1.06; P = .003), and history of unstable angina or myocardial infarction within the past 6 months (OR, 2.20; 95% CI, 1.29-3.77; P = .004), moderate or severe congestive heart failure (OR, 2.44; 95% CI, 1.31-4.55; P = .005), chronic obstructive pulmonary disease (on medications, OR, 1.61 [95% CI, 1.06-2.43; P = .024]; on home oxygen, OR, 2.52 [95% CI, 1.44-4.41; P = .001]), and prior ipsilateral carotid endarterectomy (OR, 1.56; 95% CI, 1.09-2.25; P = .016), whereas preoperative P2Y12 use was associated with a lower odds of 30-day stroke or death (OR, 0.57; 95% CI, 0.39-0.85; P = .005). A 30-point risk prediction model created based on these criteria produced a C statistic of 0.72 and Hosmer-Lemeshow goodness of fit of 0.97. Internal validation demonstrated good discrimination with a bias corrected area under the receiver operating characteristic curve of 0.70 with a calibration slope of 1.00. CONCLUSIONS: This Vascular Quality Initiative TCAR risk score calculator can be used to estimate the risk of stroke or death within 30 days of the procedure. Because TCAR is commonly used to treat patients with high surgical risk for carotid endarterectomy, this risk score will help to guide treatment decisions in patients being considered for TCAR.

Risk factors and impact of postoperative hypotension after carotid artery stenting in the Vascular Quality Initiative.

OBJECTIVE: Hypotension is a frequent complication of carotid artery stenting (CAS). Although common, its occurrence is unpredictable, and association with adverse events has not been well defined. The aim of this study was to identify predictors of postoperative hypotension after CAS and the association with stroke/transient ischemic attack (TIA), major adverse cardiac events (MACEs), increased length of stay (LOS), and in-hospital mortality. METHODS: This is a retrospective analysis of all CAS procedures, including transfemoral CAS (TF-CAS) and transcarotid artery revascularization (TCAR), performed in the Vascular Quality Initiative between 2003 and 2018. The primary study end point was postoperative hypotension, defined as hypotension treated with continuous infusion of a vasoactive agent for ≥15 minutes. Secondary end points included any postoperative neurologic events (stroke/TIA), MACEs (myocardial infarction, congestive heart failure, and dysrhythmias), prolonged LOS (>1 day), and in-hospital mortality. Patients' demographics predictive of hypotension were determined by multivariable logistic regression, and a risk score was developed for correlation with outcomes. RESULTS: During the time period of study, 24,699 patients underwent CAS; 19,716 (80%) were TF-CAS, 3879 (16%) were TCAR, and 1104 (4%) were not defined. Fifty-six percent were for symptomatic disease, 75% were for a primary atherosclerotic lesion, and 72% were performed under local or regional anesthesia. Postoperative hypotension occurred in 15% of TF-CAS and 14% of TCAR patients (P = .50). Patients with hypotension (vs no hypotension) had higher rates of stroke/TIA (7.3% vs 2.6%; P < .001), MACEs (9.6% vs 2.1%; P < .001), prolonged LOS (65% vs 28%; P < .001), and in-hospital mortality (2.9% vs 0.7%; P < .001). By multivariable analysis, risk factors associated with hypotension included an atherosclerotic (vs restenotic) lesion (odds ratio, 2.2; 95% confidence interval, 2.0-2.4; P < .001), female sex (1.3 [1.2-1.4]; P < .001), positive stress test result (1.3 [1.2-1.4]; P < .001), age 70 to 79 years (1.1 [1.1-1.3]; P < .002), age >80 years (1.2 [1.1-1.4]; P < .001), history of myocardial infarction or angina (1.3 [1.2-1.4]; P < .001), and an urgent (vs elective) procedure (1.1 [1.0-1.2]; P < .01). A history of hypertension was protective (0.9 [0.8-0.9]; P < .02). A normalized risk score for hypotension was created from the multivariable model. Increasing risk scores correlated directly with rates of adverse events, including postoperative stroke/TIA, MACEs, increased LOS, and increased in-hospital mortality. CONCLUSIONS: Hypotension after CAS is associated with adverse neurologic and cardiac events as well as with prolonged LOS and in-hospital mortality. A scoring tool may be valuable in stratifying patients at risk. Interventions aimed at preventing postoperative hypotension may improve outcomes with CAS.

Protamine use in transcarotid artery revascularization is associated with lower risk of bleeding complications without higher risk of thromboembolic events.

OBJECTIVE: Recent studies have found that transcarotid artery revascularization (TCAR) is associated with lower risk of stroke or death compared with transfemoral carotid artery stenting but higher risk of bleeding complications, presumably associated with the need for an incision. Heparin anticoagulation is universally used during TCAR, so protamine use may reduce bleeding complications. However, the safety and effectiveness of protamine use in TCAR are unknown. We therefore evaluated the impact of protamine use on perioperative outcomes after TCAR in the Vascular Quality Initiative TCAR Surveillance Project. METHODS: We performed a retrospective review of patients undergoing TCAR in the Vascular Quality Initiative TCAR Surveillance Project from September 2016 to April 2019. We assessed in-hospital outcomes using propensity score-matched cohorts of patients who did and did not receive protamine. The primary efficacy end point was access site bleeding complications, and the primary safety end point was in-hospital stroke or death. Secondary end points included the individual end points of stroke, death, transient ischemic attack, myocardial infarction, congestive heart failure exacerbation, and hemodynamic instability. RESULTS: Of the 5144 patients undergoing TCAR, all patients received heparin and 4072 (79%) patients received protamine. We identified 944 matched pairs of patients who did and did not receive protamine. Protamine use was associated with a significantly lower risk of bleeding complications (2.8% vs 8.3%; relative risk [RR], 0.33; 95% confidence interval [CI], 0.21-0.52; P < .001), including bleeding that resulted in interventional treatment (1.0% vs 3.6%; RR, 0.26; 95% CI, 0.13-0.54; P < .001) and in blood transfusion (1.2% vs 3.9%; RR, 0.30; 95% CI, 0.15-0.58; P <.001). There were no statistically significant differences in in-hospital stroke or death for patients who received protamine and those who did not (1.6% vs 2.2%; RR, 0.71; 95% CI, 0.37-1.39; P = .32); however, there was a trend toward lower risk of stroke for patients who received protamine (1.1% vs 2.0%; RR, 0.53; 95% CI, 0.24-1.13; P = .09). There were also no statistically significant differences in the rates of transient ischemic attack (0.4% vs 1.1%; RR, 0.40; 95% CI, 0.13-1.28; P = .11), myocardial infarction (0.4% vs 0.8%; RR, 0.50; 95% CI, 0.15-1.66; P = .25), heart failure exacerbation (0.4% vs 0.3%; RR, 1.33; 95% CI, 0.30-5.96; P = .71), or postoperative hypotensive hemodynamic instability (16% vs 15%; RR, 1.06; 95% CI, 0.83-1.35; P = .50) with protamine use. CONCLUSIONS: Protamine can be safely used in TCAR to reduce the risk of perioperative bleeding complications without increasing the risk of thrombotic events.

The role of transfemoral carotid artery stenting with proximal balloon occlusion embolic protection in the contemporary endovascular management of carotid artery stenosis.

OBJECTIVE: Recent data have shown that transcarotid artery revascularization (TCAR) with flow reversal provides a superior method of embolic protection compared with transfemoral carotid artery stenting (tfCAS) with distal embolic protection. Flow reversal or flow arrest systems with proximal endovascular balloon occlusion can also be used through the transfemoral approach; however, their outcomes compared with TCAR with flow reversal and tfCAS with distal embolic protection are poorly described. METHODS: We performed a retrospective review of all patients undergoing tfCAS with proximal balloon occlusion, tfCAS with distal embolic protection, and TCAR with flow reversal in the Society for Vascular Surgery Vascular Quality Initiative from March 2005 to May 2019. We assessed in-hospital outcomes in propensity score-matched cohorts of patients using tfCAS with proximal balloon occlusion as the comparison cohort. The primary outcome was stroke or death. Secondary end points included the individual outcomes of stroke, death, transient ischemic attack (TIA), and myocardial infarction. RESULTS: Of the 24,232 patients undergoing carotid artery stenting, 561 (2.3%) procedures were performed through tfCAS with proximal balloon occlusion, 18,126 (74%) through tfCAS with distal embolic protection, and 5545 (22.9%) through TCAR with flow reversal. After matching, 463 pairs of patients undergoing tfCAS with proximal balloon occlusion and tfCAS with distal embolic protection were identified. There were no differences in stroke or death (proximal balloon, 3.2%; distal embolic protection, 3.7%; relative risk [RR], 0.88; 95% confidence interval [CI], 0.45-1.73; P = .73), stroke (2.4% vs 2.6%; RR, 0.92; 95% CI, 0.42-2.00; P = .83), death (1.1% vs 1.5%; RR, 0.71; 95% CI, 0.41-3.15; P = .80), TIA (1.7% vs 1.5%; RR, 1.14; 95% CI, 0.41-3.15; P = .80), or myocardial infarction (0.4% vs 0.6%; RR, 0.67; 95% CI, 0.11-3.99; P = .65). However, after matching 357 pairs of patients undergoing tfCAS with proximal balloon occlusion and TCAR with flow reversal, tfCAS with proximal balloon occlusion was associated with higher rates of stroke or death (3.1% vs 0.8%; RR, 3.67; 95% CI, 1.02-13.14; P = .03) and a trend toward higher rates of stroke (2.5% vs 0.8%; RR, 3.00; 95% CI, 0.81-11.08; P = .08) and death (0.8% vs 0.0%; P = .08), but no statistically significant differences in TIA (0.8% vs 0.8%; P > .99) or myocardial infarction (0.6% vs 0.3%; RR, 2.00; 95% CI, 0.18-22.06; P = .56). CONCLUSIONS: Compared with tfCAS with distal embolic protection, tfCAS with proximal balloon occlusion has similar major outcomes. However, tfCAS with proximal balloon occlusion does not offer the same degree of embolic protection compared with TCAR with flow reversal, given the significantly higher risk of perioperative stroke or death.

Clinical impact of sex on carotid revascularization.

BACKGROUND: The impact of sex in the management of carotid disease is unclear in the current literature. Therefore, we evaluated the effect of sex on perioperative outcomes following carotid endarterectomy (CEA) and carotid artery stenting (CAS). METHODS: We included patients who underwent CEA or CAS between 2012 and 2017 in the Vascular Quality Initiative database. Our primary outcome was perioperative stroke/death. Secondary outcomes were in-hospital stroke, 30-day mortality, and in-hospital MI. We compared perioperative outcomes between female and male patients, stratified by treatment modality and symptom status, and used multivariable regression to account for differences in baseline characteristics. RESULTS: A total of 83,436 patients underwent either a CEA (71,383) or CAS (12,053). Asymptomatic and symptomatic CEA females were less likely to be on a preoperative antiplatelet agent, when compared to males. Females overall, were less likely to be on a preoperative statin and more likely to have chronic obstructive pulmonary disease. Within the CAS cohort, females were more likely to have a previous ipsilateral CEA. There were no differences between males and females in major adverse events following CEA for asymptomatic disease. Following CEA for symptomatic disease, there was no difference in stroke/death rate or in-hospital stroke. However, females experienced a higher 30-mortality after adjustment (univariate: 1.0% vs 0.7%, P = .04; adjusted: odds ratio [OR], 1.4:1.02-1.94). Following CAS for asymptomatic disease, females experienced a higher rate of perioperative stroke/death (2.9% vs 1.9% P = .02; OR, 1.5: 1.05-2.03) and in-hospital stroke (2.1% vs 1.2% P = .01; OR, 1.8: 1.20-2.60). There were no differences in outcomes for symptomatic females vs males undergoing CAS. CONCLUSIONS: Females with carotid disease less frequently receive optimal medical treatment with antiplatelet agents and statins. This is an important target area for quality improvement issue in both females and males. Furthermore, among symptomatic CEA patients the female sex is associated with higher mortality and among asymptomatic CAS patients, females experience higher rates of stroke/death. These findings suggest that careful patient selection is necessary in the treatment of female patients. Quality improvement projects should be created to further investigate and eliminate the disparities of optimal medical management between the sexes.

Outcomes of carotid endarterectomy in the Vascular Quality Initiative based on patch type.

OBJECTIVE: The Vascular Quality Initiative (VQI) is the largest registry of vascular surgical procedures and as such is capable of distinguishing small but important differences in outcomes. The goal of this study was to determine the outcomes of carotid endarterectomy (CEA) based on patch type, including bovine pericardium, autogenous vein, polytetrafluoroethylene (PTFE), and Dacron. METHODS: All primary CEAs performed with primary repair and patching (n = 70,987) within the VQI were retrospectively analyzed. Reoperative CEA and combined CEA and coronary artery bypass were excluded. Rates of any postoperative neurologic event, return to the operating room (bleeding, neurologic event, or wound complication), and restenosis (>50% and >80%) at 1-year follow-up were primary outcomes. Rates were compared by patch type using χ2 and Bonferroni analysis. Multivariate hierarchical logistic regression models were used to predict end points of postoperative neurologic event, return to the operating room, and 1-year restenosis. RESULTS: During the period of study, 2003 to 2017, there were 70,987 CEAs entered into the VQI registry. Bovine pericardium was the patch material with the highest frequency of use (n = 51,480), followed by Dacron (n = 12,356), vein (n = 1460), and PTFE (n = 1638). Bovine pericardium, vein, and Dacron had lower rates of postoperative neurologic events compared with PTFE or primary repair. Bovine pericardium had the lowest rate of restenosis at 1 year. By multivariate analysis, bovine pericardium (odds ratio [OR], 0.70; 95% confidence interval [CI], 0.56-0.89) and protamine use (OR, 0.74; 95% CI, 0.60-0.91) were associated with a lower incidence of return to the operating room. The use of Dacron, vein, and PTFE patches was not significantly different from the reference of primary closure. Multivariate analysis of postoperative neurologic events revealed that bovine pericardium (OR, 0.59; CI, 0.48-0.72) and Dacron (OR, 0.56; CI, 0.43-0.72) were associated with lower incidence of stroke or transient ischemic attack, whereas vein and PTFE were no different from primary closure. Bovine pericardium (OR, 0.57; CI, 0.44-0.75), Dacron (OR, 0.70; CI, 0.50-0.98), vein (OR, 0.72; CI, 0.53-0.98), and never smoking (OR, 0.87; CI, 0.78-0.96) were associated with a lower incidence of restenosis at 1 year by multivariate analysis. CONCLUSIONS: Bovine pericardium has superior outcomes both postoperatively and at 1 year compared with other patch materials. The large volume of patient data contained in the VQI makes it possible to compare outcomes that have small but meaningful differences.

In-hospital outcomes of transcarotid artery revascularization and carotid endarterectomy in the Society for Vascular Surgery Vascular Quality Initiative.

OBJECTIVE: Transcarotid artery revascularization (TCAR) with flow reversal offers a less invasive option for carotid revascularization in high-risk patients and has the lowest reported overall stroke rate for any prospective trial of carotid artery stenting. However, outcome comparisons between TCAR and carotid endarterectomy (CEA) are needed to confirm the safety of TCAR outside of highly selected patients and providers. METHODS: We compared in-hospital outcomes of patients undergoing TCAR and CEA from January 2016 to March 2018 using the Society for Vascular Surgery Vascular Quality Initiative TCAR Surveillance Project registry and the Society for Vascular Surgery Vascular Quality Initiative CEA database, respectively. The primary outcome was a composite of in-hospital stroke and death. RESULTS: A total of 1182 patients underwent TCAR compared with 10,797 patients who underwent CEA. Patients undergoing TCAR were older (median age, 74 vs 71 years; P < .001) and more likely to be symptomatic (32% vs 27%; P < .001); they also had more medical comorbidities, including coronary artery disease (55% vs 28%; P < .001), chronic heart failure (20% vs 11%; P < .001), chronic obstructive pulmonary disease (29% vs 23%; P < .001), and chronic kidney disease (39% vs 34%; P = .001). On unadjusted analysis, TCAR had similar rates of in-hospital stroke/death (1.6% vs 1.4%; P = .33) and stroke/death/myocardial infarction (MI; 2.5% vs 1.9%; P = .16) compared with CEA. There was no difference in rates of stroke (1.4% vs 1.2%; P = .68), in-hospital death (0.3% vs 0.3%; P = .88), 30-day death (0.9% vs 0.4%; P = .06), or MI (1.1% vs 0.6%; P = .11). However, on average, TCAR procedures were 33 minutes shorter than CEA (78 ± 33 minutes vs 111 ± 43 minutes; P < .001). Patients undergoing TCAR were also less likely to incur cranial nerve injuries (0.6% vs 1.8%; P < .001) and less likely to have a postoperative length of stay >1 day (27% vs 30%; P = .046). On adjusted analysis, there was no difference in terms of stroke/death (odds ratio, 1.3; 95% confidence interval, 0.8-2.2; P = .28), stroke/death/MI (odds ratio, 1.4; 95% confidence interval, 0.9-2.1, P = .18), or the individual outcomes. CONCLUSIONS: Despite a substantially higher medical risk in patients undergoing TCAR, in-hospital stroke/death rates were similar between TCAR and CEA. Further comparative studies with larger samples sizes and longer follow-up will be needed to establish the role of TCAR in extracranial carotid disease management.