Younger patients have worse outcomes after peripheral endovascular interventions for suprainguinal arterial occlusive disease.

OBJECTIVE: The choice of intervention for treating suprainguinal arterial disease, open bypass vs endovascular intervention, is often tempered by patient age and comorbidities. In the present study, we compared the association of patient age with 1-year major adverse limb events (MALE)-free survival and reintervention-free survival (RFS) rates among patients undergoing intervention for suprainguinal arterial disease. METHODS: The Vascular Quality Initiative datasets for bypass and peripheral endovascular intervention (PVI; aorta and iliac only) were queried from 2010 to 2017. The patients were divided into two age groups: <60 and ≥60 years at the procedure. Age-stratified propensity matching of patients in bypass and endovascular procedure groups by demographic characteristics, comorbidities, and disease severity was used to identify the analysis samples. The 1-year MALE-free survival and RFS rates were compared using the log-rank test and Kaplan-Meier plots. Proportional hazard Cox regression was used to perform propensity score-adjusted comparisons of MALE-free survival and RFS. RESULTS: A total of 14,301 cases from the Vascular Quality Initiative datasets were included in the present study. Propensity matching led to 3062 cases in the ≥60-year group (1021 bypass; 2041 PVI) and 2548 cases in the <60-year group (1697 bypass; 851 PVI). In the crude comparison of the matched samples, the older patients undergoing bypass had had significantly greater in-hospital (4.6% vs 0.9%; P < .001) and 1-year (10.5% vs 7.5%; P = .005) mortality compared with those who had undergone endovascular intervention. The rates of MALE (7.5% vs 14.3%; P < .001) and reintervention (6.7% vs 12.7%; P < .001) or death were significantly higher for the younger group undergoing PVI than bypass at 1 year. However, the rates of MALE (12.9% vs 14.3%; P = .298) and reintervention (12.7% vs 12.9%; P = .881) or death for were similar both procedures for the older group. Both log-rank analyses and the adjusted propensity score analyses of MALE-free survival and RFS in the two age groups confirmed these findings. The adjusted comparison of outcomes using propensity score matching favored PVI at 1-year survival (hazard ratio, 1.4; 95% confidence interval, 1.1-1.9; P = .003) for the older group but was not different for the younger group (hazard ratio, 0.6; 95% confidence interval, 0.3-1.0; P = .054). CONCLUSIONS: Among the patients aged <60 years undergoing intervention for suprainguinal arterial disease, the choice of therapy should be open surgical intervention given the higher risk of reintervention and MALE with endovascular intervention. Endovascular intervention should be favored for patients aged ≥60 years because of reduced perioperative mortality.

Trans-ethnic Meta-analysis and Functional Annotation Illuminates the Genetic Architecture of Fasting Glucose and Insulin.

Knowledge of the genetic basis of the type 2 diabetes (T2D)-related quantitative traits fasting glucose (FG) and insulin (FI) in African ancestry (AA) individuals has been limited. In non-diabetic subjects of AA (n = 20,209) and European ancestry (EA; n = 57,292), we performed trans-ethnic (AA+EA) fine-mapping of 54 established EA FG or FI loci with detailed functional annotation, assessed their relevance in AA individuals, and sought previously undescribed loci through trans-ethnic (AA+EA) meta-analysis. We narrowed credible sets of variants driving association signals for 22/54 EA-associated loci; 18/22 credible sets overlapped with active islet-specific enhancers or transcription factor (TF) binding sites, and 21/22 contained at least one TF motif. Of the 54 EA-associated loci, 23 were shared between EA and AA. Replication with an additional 10,096 AA individuals identified two previously undescribed FI loci, chrX FAM133A (rs213676) and chr5 PELO (rs6450057). Trans-ethnic analyses with regulatory annotation illuminate the genetic architecture of glycemic traits and suggest gene regulation as a target to advance precision medicine for T2D. Our approach to utilize state-of-the-art functional annotation and implement trans-ethnic association analysis for discovery and fine-mapping offers a framework for further follow-up and characterization of GWAS signals of complex trait loci.

Association of frailty index with perioperative mortality and in-hospital morbidity after elective lower extremity bypass.

OBJECTIVE: The frailty index has been linked to adverse outcomes after surgical procedures. In this study, we evaluated the association between frailty index and outcomes after elective lower extremity bypass (LEB) for lower extremity ischemia. METHODS: The American College of Surgeons National Surgical Quality Improvement Program data set (2005-2012) was used to identify patients who underwent elective LEB using diagnostic and procedure Current Procedural Terminology codes. Modified frailty index (mFI) scores, derived from the Canadian Study of Health and Aging, were categorized into three groups: low, medium, and high. Association of mFI with 30-day postoperative death (POD), myocardial infarction (MI), cardiopulmonary events (CPEs), deep tissue surgical site infection (SSI), and graft failure (GF) was evaluated. Both univariate and multivariable regression analyses-adjusted for age, sex, American Society of Anesthesiologists class, body mass index, and creatinine levels-were used to assess the effect of frailty on each outcome. RESULTS: Of 12,677 patients (mean age, 67.7 ± 11.1 years) identified who underwent elective LEB, POD occurred in 265 (2.1% overall). Postoperative MI, SSI, CPEs, and GF occurred in 1.6%, 2.5%, 3.1%, and 4.3%, respectively. The mean mFI of the entire sample was 0.3 ± 0.1. Adjusted odds ratio for development of any morbidity in the group with the highest mFI was 1.36 (95% confidence interval, 1.08-1.72; P = .010) compared with the low frailty group. Patients with higher mFI were more likely to develop MI and CPEs but not SSI or GF. Univariate and multivariable analyses showed a significantly increased risk of POD among those in the highest mFI tertile. Female sex and age, increased American Society of Anesthesiologists class and creatinine levels, and decreased body mass index independently predicted increased mortality. The addition of categorical mFI improved models with these variables. CONCLUSIONS: Higher mFI is independently associated with higher mortality and morbidity. Preoperative mFI assessment may be considered an additional screening tool for risk stratification among patients undergoing LEB.

Differences in patient selection and outcomes based on abdominal aortic aneurysm diameter thresholds in the Vascular Quality Initiative.

OBJECTIVE: Randomized trials have shown no benefit for repair of small abdominal aortic aneurysms (AAAs), although repair of small AAAs is widely practiced. It has also been suggested that repair of large-diameter AAAs may incur worse outcomes. We sought to examine differences in patient selection, operative outcomes, and survival after elective endovascular aneurysm repair (EVAR) based on AAA diameter thresholds. METHODS: Elective EVARs for asymptomatic AAAs in the Vascular Quality Initiative were studied from 2003 to 2017. AAAs were classified by diameter as small (<5 cm in women, <5.5 cm in men), medium (5-6.5 cm in women, 5.5-6.5 cm in men), and large (≥6.5 cm). Patient characteristics and operative factors were compared using univariate analyses and established risk prediction models. Effects of AAA diameter on reintervention and mortality were assessed using Kaplan-Meier and multivariable Cox regression analyses. RESULTS: Of 22,975 patients undergoing EVAR, 41% (9353), 47% (10,842), and 12% (2780) had small, medium, and large AAAs, respectively. Patients with small AAAs were younger and had fewer comorbidities. Consequently, patients with small AAAs were more likely to have low predicted operative mortality risk and 5-year mortality risk based on risk models (P < .001 for both). For operative outcomes, 30-day mortality was significantly different across diameter categories (small, 0.4%; medium, 0.9%; large, 1.6%; P < .001). EVAR for large AAAs had the highest rates of multiple medical complications, including myocardial infarction (P < .001), respiratory complications (P = .001), and renal complications (P < .001). In contrast, EVAR for small AAAs had the lowest rates of type I endoleak at completion and reoperation during index hospitalization, shortest operative times, and shortest hospital length of stay (P < .001 for all). Aneurysm diameter was associated with differential 1-year reintervention-free survival (92% small vs 89% medium vs 82% large; P < .001) and 5-year overall survival (88% small vs 81% medium vs 75% large; P < .001). Multivariable models showed that compared with medium AAAs, small AAAs had an independent protective effect against 1-year reintervention or death (hazard ratio [HR], 0.82; P = .003) and 5-year mortality (HR, 0.78; P = .001). Conversely, compared with medium AAAs, large AAAs carried an independent increased risk of 1-year reintervention or death (HR, 1.75; P < .001) and 5-year mortality (HR, 1.50; P < .001). CONCLUSIONS: Small AAAs represent >40% of elective EVARs in the Vascular Quality Initiative. Patients with small AAAs selected for repair are younger and have fewer comorbidities. Consequently, EVAR for small AAAs carries lower risk of operative and 5-year mortality. Aneurysm diameter is independently associated with reinterventions and mortality after EVAR, suggesting that AAA diameter may have an important clinical effect on outcomes.

Comparison of Early and Late Post-operative Outcomes after Supra-inguinal Bypass for Aortoiliac Occlusive Disease.

OBJECTIVE: The choice for surgical revascularisation for aortoiliac occlusive disease is often tempered by patient comorbidities. This study compares peri-operative outcomes and the association between choice of operation and one year major adverse limb event (MALE) free survival and five year mortality. METHODS: The Vascular Study Group of New England (VSGNE) dataset for supra-inguinal bypass operations from 2009 to 2015 was queried. This study excluded cases with bypass other than aortofemoral (AFB), axillofemoral (AXB), and femorofemoral (FFB), and those with endovascular interventions or femoral endarterectomy. Cases combined with other procedures, indications other than occlusive disease, and missing pathology were also excluded. Patients were divided into three groups: AFB, AXB, and FFB. Thirty day post-operative death (POD) and adverse events were compared using univariable and multivariable analyses. One year MALE free survival was compared between groups with log rank test and Kaplan-Meier plot. Proportional hazard Cox regression was used for adjusted comparison of MALE free and five year survival. RESULTS: In total, 1,602 cases were included: 207 (12.9%) AXB; 872 (54.4%) AFB; 523 (32.6%) FFB. AXB patients were older with more comorbidities. Post-operative complications and POD rates were significantly higher for AXB (p < .05). On adjusted analyses, AXB increased the hazard of one year MALE (hazard ratio [HR] 1.76, 95% confidence interval [CI] 1.12-2.78; p = .014) and five year mortality (HR 1.54; 95% CI 1.11-2.41; p = .009). Both FFB and AFB had similar one year MALE free survival but significantly better one year MALE free survival than AXB. CONCLUSION: After adjusting for confounding variables, and while acknowledging limitations related to the VSGNE data set, FFB led to significantly lower rates of post-operative complications than AXB. FFB may serve as the extra-anatomical operation of choice in high risk patients with extensive disease, who cannot undergo AFB, provided that anatomy permits. AFB should be performed preferentially in low risk patients with appropriate anatomy. Owing to its higher complications rates, the study suggests that AXB should be limited to patients with no other option for revascularisation.

Trends and Outcomes of Pediatric Vascular Injuries in the United States: An Analysis of the National Trauma Data Bank.

BACKGROUND: According to the Center for Disease Control and Prevention, trauma is the leading cause of death in children aged >1 year in the United States (US). Although vascular injuries occur in only 0.6-1% of pediatric patients with trauma, they are a major mortality contributor. This study aims to examine epidemiology and outcomes after pediatric vascular injuries (PedVIs) in the US. METHODS: The National Trauma Data Bank (2002-2012) was queried to identify children (0-16) with PedVIs. Patients were categorized based on their demographics, location, and mechanism and presenting trauma severity (injury severity score [ISS] and shock). Study was divided into two 5-year periods (P1: 2002-2006; P2: 2007-2012) to study the trends in pediatric vascular trauma presentation and outcomes (hospital death and extended length of stay [LOS > 8 days]) using adjusted analyses. RESULTS: Analyses were performed on 3,408 cases; who were male (73.7%) and Caucasian (52.8%) with a mean age of 10.5 ± 4.5 years. The Southern region of the US saw the highest increase in PedVIs (P2 versus P1: 38.3% vs. 25.0%, P < 0.05). Blunt injuries constituted most of these injuries (57%). Firearm (36.9%) and motor vehicle crash (MVC) (34%) were the most common lethal mechanisms of injury. Despite the significant decrease in MVC rates (P2 versus P1: 17.4% vs. 22.6%, P < 0.05), firearm rates were unchanged. Upper extremity injuries were the most common anatomically (34.9%). ISS and shock were significantly decreased during P2. Mortality occurred in 7.9% of patients, which significantly decreased (P2 versus P1: 6.3% vs. 10.9%, P < 0.001) without a significant change in LOS. Odds of mortality decreased by 32% during P2 (P = 0.08) and was independently associated with penetrating mechanism of injury (odds ratio [OR]: 1.97; 95% confidence interval [CI]: 1.22-3.19, P = 0.006), shock at presentation (OR: 5.48; 95% CI: 3.55-8.46, P < 0.001); ISS (OR: 1.08; 95% CI: 1.06-1.27, P < 0.001), and Glasgow Coma Score < 9 (OR: 11.21; 95% CI: 7.18-17.49, P < 0.001). CONCLUSIONS: We observed a significant decrease in the overall severity of injury and in-hospital mortality concurrent with the observation of a significant decrease in the rates of pediatric MVC vascular injuries. Public health policies directed toward firearm safety may further decrease PedVIs and mortality among this vulnerable population.

Intraoperative Heparin Use during Upper Extremity Arteriovenous Access Creation Does Not Affect Outcomes.

BACKGROUND: There are conflicting data about the effect of heparin use on perioperative outcomes during upper extremity arteriovenous (AV) access creation. Our goal was to assess the effect of the use and degree of intraoperative heparin on perioperative outcomes after AV access creation. METHODS: All upper extremity AV access cases performed at a tertiary academic medical center between 2014 and 2017 were reviewed. Patient and procedural details including intraoperative heparin use and dosing as well as protamine use were analyzed. Full heparin dose was defined as 80-100 U/kg and partial heparin dose as less than 80 U/kg. Perioperative arterial thrombosis or distal embolism, hematoma, and early loss of primary patency within 30 days were evaluated. Multivariate analysis was performed to assess the effect of heparin use. RESULTS: There were 550 AV access cases identified: brachiocephalic (37.5%), brachiobasilic (29.3%), and radiocephalic fistulas (12.9%), and AV grafts (16.9%). Average patient age was 62.6 years and 58.9% were male. Full heparinization was used in 21.3%, partial heparinization in 58.7%, and no heparin was used in 20% of cases. Protamine was used in 94.9% of full heparin cases and 51.4% of partial heparin cases. No perioperative arterial thrombosis or distal embolism was observed. Perioperative wound hematoma rate was 3.4%, 3.1%, and 0.9% in full heparin, partial heparin, and no heparin cohorts, respectively (P = 0.42). Early loss of primary patency was 11.1%, 7.7%, and 6.4% for full heparin, partial heparin, and no heparin cases, respectively (P = 0.39). There were no differences in return to the operating room or perioperative survival. On multivariable analysis, full heparin use (odds ratio [OR] 3.82, 95% confidence interval [CI] 0.41-35.9, P = 0.24) and partial heparin (OR 4.03, 95% CI 0.5-32.6, P = 0.19) use were not significantly different from no heparin cases with respect to 30-day perioperative hematoma rate. Full heparin (OR 1.76, 95% CI 0.65-4.78, P = 0.26) and partial heparin (OR 1.13, 95% CI 0.46-2.75, P = 0.79) were not significantly different from no heparin cases with respect to early loss of primary patency. CONCLUSIONS: Intraoperative heparin use, at full or partial doses, did not affect perioperative outcomes after AV access creation. Overall complication event rate was low for all groups. AV access can be safely performed without intraoperative heparin use.

Improved access to health care in Massachusetts after 2006 Massachusetts Healthcare Reform Law is associated with a significant decrease in mortality among vascular surgery patients.

BACKGROUND: Access to medical care, by adequate insurance coverage, has a direct impact on outcomes for patients undergoing vascular procedures. We evaluated in-hospital mortality for patients undergoing index vascular procedures before and after the Massachusetts Healthcare Reform Law (MHRL) in 2006, which mandated insurance for all Massachusetts residents, both in Massachusetts and throughout the United States. METHODS: The National Inpatient Sample was queried to identify patients undergoing interventions for peripheral arterial disease, carotid artery stenosis, and abdominal aortic aneurysms based on International Classification of Diseases, Ninth Revision, Clinical Modification procedural and diagnostic codes. The cohort was then divided into patients treated within Massachusetts (MA) and non-Massachusetts (NMA) hospitals. Two time intervals were examined: before (2003-2006, P1) and after the MHRL (2007-2011, P2). The primary outcome of interest included in-hospital mortality. Patients in MA and NMA hospitals were described in terms of demographics and presentation by time interval (P2 vs P1) compared using χ2 and t-tests. Weighted logistic regression with term modeling change in the odds ratio (OR) for P2 was performed to test and to estimate trends in mortality. Time (year of procedure) and region interactions were investigated by inclusion of time-region interactions in our analyses. Subgroup analysis was performed for P2 vs P1 among nonwhite, nonelderly, and low-income patients. RESULTS: We identified 306,438 patients who underwent repair of abdominal aortic aneurysm, lower extremity bypass, or carotid endarterectomy in MA and NMA hospitals. MA hospital patients had an increase in both Medicaid and private insurance status after the MHRL (P1 = 2.6% and 21% vs P2 = 3.3% and 21.7%, respectively; P = .034). In-hospital mortality trended down for all groups across the entire study. In comparing P2 vs P1 trends, MA hospital odds of mortality per year was lowered by 26% (OR, 0.74; 95% confidence interval [CI], 0.56-0.99; P = .042) not seen in NMA hospitals (OR, 1.03; 95% CI, 0.97-1.09; P = .405). Time and region interaction terms indicated significant time trend difference in both unadjusted (P = .031) and adjusted (P = .033) analysis in MA hospitals not observed in NMA hospitals. This pattern continued when the samples were stratified by procedure. Patients undergoing vascular procedures in MA hospitals had a significantly lowered OR of mortality, with fewer patients presenting at late disease stages in P2 vs P1. Nonelderly patients in Massachusetts, who benefit from the Medicaid expansion provided by the MHRL, had a profound 92% drop in odds of mortality in P2 vs P1 (OR, 0.08; 95% CI, 0.010-0.641; P = .017) compared with the 14% drop in NMA (OR, 0.86; 95% CI, 0.709-1.032; P = .103). CONCLUSIONS: The 2006 MHRL is associated with a decrease in mortality for patients undergoing index vascular surgery procedures in MA compared with NMA hospitals. This study suggests that governmental policy may play a key role in positively affecting the outcomes for patients.

External validation of Vascular Study Group of New England risk predictive model of mortality after elective abdominal aorta aneurysm repair in the Vascular Quality Initiative and comparison against established models.

OBJECTIVE: The purpose of this study is to externally validate a recently reported Vascular Study Group of New England (VSGNE) risk predictive model of postoperative mortality after elective abdominal aortic aneurysm (AAA) repair and to compare its predictive ability across different patients' risk categories and against the established risk predictive models using the Vascular Quality Initiative (VQI) AAA sample. METHODS: The VQI AAA database (2010-2015) was queried for patients who underwent elective AAA repair. The VSGNE cases were excluded from the VQI sample. The external validation of a recently published VSGNE AAA risk predictive model, which includes only preoperative variables (age, gender, history of coronary artery disease, chronic obstructive pulmonary disease, cerebrovascular disease, creatinine levels, and aneurysm size) and planned type of repair, was performed using the VQI elective AAA repair sample. The predictive value of the model was assessed via the C-statistic. Hosmer-Lemeshow method was used to assess calibration and goodness of fit. This model was then compared with the Medicare, Vascular Governance Northwest model, and Glasgow Aneurysm Score for predicting mortality in VQI sample. The Vuong test was performed to compare the model fit between the models. Model discrimination was assessed in different risk group VQI quintiles. RESULTS: Data from 4431 cases from the VSGNE sample with the overall mortality rate of 1.4% was used to develop the model. The internally validated VSGNE model showed a very high discriminating ability in predicting mortality (C = 0.822) and good model fit (Hosmer-Lemeshow P = .309) among the VSGNE elective AAA repair sample. External validation on 16,989 VQI cases with an overall 0.9% mortality rate showed very robust predictive ability of mortality (C = 0.802). Vuong tests yielded a significant fit difference favoring the VSGNE over then Medicare model (C = 0.780), Vascular Governance Northwest (0.774), and Glasgow Aneurysm Score (0.639). Across the 5 risk quintiles, the VSGNE model predicted observed mortality significantly with great accuracy. CONCLUSIONS: This simple VSGNE AAA risk predictive model showed very high discriminative ability in predicting mortality after elective AAA repair among a large external independent sample of AAA cases performed by a diverse array of physicians nationwide. The risk score based on this simple VSGNE model can reliably stratify patients according to their risk of mortality after elective AAA repair better than other established models.

Routine Use of Ultrasound Guidance in Femoral Arterial Access for Peripheral Vascular Intervention Decreases Groin Hematoma Rates in High-Volume Surgeons.

BACKGROUND: There is a documented learning curve when adopting ultrasound guidance (UG) to aid vascular access. In the Vascular Study Group of New England (VSGNE), routine UG during percutaneous femoral artery access was shown to protect against the complication of groin hematoma. We sought to confirm this finding in the Vascular Quality Initiative (VQI), a data set with a larger sample size and broader geographic distribution, and to evaluate the effects of ultrasound usage and interventionalist volume on hematoma rates following peripheral vascular interventions (PVIs). METHODS: The VQI PVI database (2010-2014) was queried to identify the complication of groin hematoma after 43,947 PVIs performed via femoral artery access. Both procedure- and interventionalist-level analyses were performed. Multivariable logistic regression was used to assess factors associated with hematoma. Multivariable Poisson regression analyses were used to compare hematoma rates between routine (≥80% of PVIs) and selective (<80% of PVIs) users of UG in the adjusted overall sample and in subgroups based on interventionalist volume (low: <10 PVIs/year; medium: 10-50 PVIs/year; high: >50 PVIs/year). RESULTS: The overall groin hematoma rate was 3.2%, and lower hematoma rates correlated with increasing annual interventionalist volume (low vs. medium vs. high volume: 3.7% vs. 3.4% vs. 2.9%; P = 0.011). UG was associated with increased risk of hematoma (odds ratio [OR] 1.29, 95% confidence interval [CI] 1.13-1.47, P < 0.001), but this risk was isolated to patients treated by selective (OR 1.33, 95% CI 1.17-1.53, P < 0.001) rather than routine users of UG (OR 0.85, 95% CI 0.55-1.33, P = 0.484). In the overall interventionalist-level analysis, routine UG was not found to be protective against hematoma (rate ratio [RR] 0.97, 95% CI 0.85-1.11, P = 0.677), in contrast to what was previously reported from the VSGNE. However, subgroup analysis revealed that routine UG was further protective against hematoma among high-volume interventionalists (RR 0.73, 95% CI 0.54-0.97, P = 0.030). CONCLUSIONS: UG in percutaneous femoral artery access may decrease the complication rate of groin hematoma, especially as an interventionalist's volume increases and as selective use transforms into routine adoption. With repetition and practice, interventionalists likely overcome the learning curve associated with adoption of an unfamiliar technology and potentially improve patient outcomes.

Impact of common genetic determinants of Hemoglobin A1c on type 2 diabetes risk and diagnosis in ancestrally diverse populations: A transethnic genome-wide meta-analysis.

BACKGROUND: Glycated hemoglobin (HbA1c) is used to diagnose type 2 diabetes (T2D) and assess glycemic control in patients with diabetes. Previous genome-wide association studies (GWAS) have identified 18 HbA1c-associated genetic variants. These variants proved to be classifiable by their likely biological action as erythrocytic (also associated with erythrocyte traits) or glycemic (associated with other glucose-related traits). In this study, we tested the hypotheses that, in a very large scale GWAS, we would identify more genetic variants associated with HbA1c and that HbA1c variants implicated in erythrocytic biology would affect the diagnostic accuracy of HbA1c. We therefore expanded the number of HbA1c-associated loci and tested the effect of genetic risk-scores comprised of erythrocytic or glycemic variants on incident diabetes prediction and on prevalent diabetes screening performance. Throughout this multiancestry study, we kept a focus on interancestry differences in HbA1c genetics performance that might influence race-ancestry differences in health outcomes. METHODS & FINDINGS: Using genome-wide association meta-analyses in up to 159,940 individuals from 82 cohorts of European, African, East Asian, and South Asian ancestry, we identified 60 common genetic variants associated with HbA1c. We classified variants as implicated in glycemic, erythrocytic, or unclassified biology and tested whether additive genetic scores of erythrocytic variants (GS-E) or glycemic variants (GS-G) were associated with higher T2D incidence in multiethnic longitudinal cohorts (N = 33,241). Nineteen glycemic and 22 erythrocytic variants were associated with HbA1c at genome-wide significance. GS-G was associated with higher T2D risk (incidence OR = 1.05, 95% CI 1.04-1.06, per HbA1c-raising allele, p = 3 × 10-29); whereas GS-E was not (OR = 1.00, 95% CI 0.99-1.01, p = 0.60). In Europeans and Asians, erythrocytic variants in aggregate had only modest effects on the diagnostic accuracy of HbA1c. Yet, in African Americans, the X-linked G6PD G202A variant (T-allele frequency 11%) was associated with an absolute decrease in HbA1c of 0.81%-units (95% CI 0.66-0.96) per allele in hemizygous men, and 0.68%-units (95% CI 0.38-0.97) in homozygous women. The G6PD variant may cause approximately 2% (N = 0.65 million, 95% CI 0.55-0.74) of African American adults with T2D to remain undiagnosed when screened with HbA1c. Limitations include the smaller sample sizes for non-European ancestries and the inability to classify approximately one-third of the variants. Further studies in large multiethnic cohorts with HbA1c, glycemic, and erythrocytic traits are required to better determine the biological action of the unclassified variants. CONCLUSIONS: As G6PD deficiency can be clinically silent until illness strikes, we recommend investigation of the possible benefits of screening for the G6PD genotype along with using HbA1c to diagnose T2D in populations of African ancestry or groups where G6PD deficiency is common. Screening with direct glucose measurements, or genetically-informed HbA1c diagnostic thresholds in people with G6PD deficiency, may be required to avoid missed or delayed diagnoses.

Differences in Infant Care Practices and Smoking among Hispanic Mothers Living in the United States.

OBJECTIVE: To assess the association between maternal birth country and adherence to the American Academy of Pediatrics safe sleep recommendations in a national sample of Hispanic mothers, given that data assessing the heterogeneity of infant care practices among Hispanics are lacking. STUDY DESIGN: We used a stratified, 2-stage, clustered design to obtain a nationally representative sample of mothers from 32 US intrapartum hospitals. A total of 907 completed follow-up surveys (administered 2-6 months postpartum) were received from mothers who self-identified as Hispanic/Latina, forming our sample, which we divided into 4 subpopulations by birth country (US, Mexico, Central/South America, and Caribbean). Prevalence estimates and aORs were determined for infant sleep position, location, breastfeeding, and maternal smoking. RESULTS: When compared with US-born mothers, we found that mothers born in the Caribbean (aOR 4.56) and Central/South America (aOR 2.68) were significantly more likely to room share without bed sharing. Caribbean-born mothers were significantly less likely to place infants to sleep supine (aOR 0.41). Mothers born in Mexico (aOR 1.67) and Central/South America (aOR 2.57) were significantly more likely to exclusively breastfeed; Caribbean-born mothers (aOR 0.13) were significantly less likely to do so. Foreign-born mothers were significantly less likely to smoke before and during pregnancy. CONCLUSIONS: Among US Hispanics, adherence to American Academy of Pediatrics safe sleep recommendations varies widely by maternal birth country. These data illustrate the importance of examining behavioral heterogeneity among ethnic groups and have potential relevance for developing targeted interventions for safe infant sleep.

Description of a risk predictive model of 30-day postoperative mortality after elective abdominal aortic aneurysm repair.

OBJECTIVE: Despite vast improvement in the field of vascular surgery, elective abdominal aortic aneurysm (AAA) repair still leads to perioperative death. Patients with asymptomatic AAAs, therefore, would benefit from an individual risk assessment to help with decisions regarding operative intervention. The purpose of this study was to describe such a 30-day postoperative (POD) risk prediction model using American College of Surgeons National Surgical Quality Improvement Project (NSQIP) data. METHODS: The NSQIP database (2005-2011) was queried for patients undergoing elective AAA repair using open or endovascular techniques. Clinical variables and known predictors of mortality were included in a full prediction model. These variables included procedure type, patient's age, functional dependence and comorbidities, and surgeon's specialty. Backward elimination with alpha-level of 0.2 was used to construct a parsimonious model. Model discrimination was evaluated in equally sized risk quintiles. RESULTS: The overall mortality rate for 18,917 elective AAA patients was 1.7%. In this model, surgeon's specialty was not predictive of POD. The most significant factors affecting POD included open repair (odds ratio [OR], 2.712; 95% confidence interval [CI], 2.119-3.469; P < .001), age >70 (OR, 2.243; 95% CI, 1.695-3.033; P < .001), functional dependency (OR, 2.290; 95% CI, 1.442-3.637; P < .001), creatinine above 2.0 mg/dL (OR, 2.1; 95% CI, 1.403-3.142; P < .001) and low hematocrit levels (OR, 2.157; 95% CI, 1.365-3.408; P = .001).The discriminating ability of the NSQIP model was reasonable (C-statistic = 0.751) and corrected to 0.736 after internal validation. The NSQIP model performed well predicting mortality among risk-group quintiles. CONCLUSIONS: The NSQIP risk prediction model is a robust vehicle to predict POD among patient undergoing elective AAA repair. This model can be used for risk stratification of patients undergoing elective AAA repair.

Role of language discordance in complication and readmission rate after infrainguinal bypass.

OBJECTIVE: Studies have shown that language discordance between treatment teams and patients leads to worse patient outcomes, including longer hospital stays, higher rates of readmission, impaired comprehension of discharge instructions, and lower treatment adherence. Yet, there is a paucity of data evaluating the effects of language discordance on postoperative outcomes among vascular surgery patients. This study compared 30-day postoperative complications and readmissions after nonemergent infrainguinal bypass between non-English-speaking (NES) and English-speaking (ES) patients. METHODS: Consecutive patients who underwent nonemergent infrainguinal bypass for claudication, ischemic rest pain, and tissue loss at an urban, academic medical center between 2007 and 2014 were identified. Patients were stratified into NES or ES groups by their self-identified primary language. Crude comparisons and multivariable analyses were performed to assess the association of primary language status with 30-day wound infections, adverse graft events (wound infections, graft thromboses, or hematomas), readmissions, and Emergency Department return visits. RESULTS: The study included 261 patients who underwent an infrainguinal bypass: 51 NES and 210 ES patients. The NES patients were older (67.4 ± 9.8 vs 63.1 ± 9.9 years; P = .005) and had a higher rate of diabetes (78.4% vs 58.6%; P = .009) and a lower rate of chronic obstructive pulmonary disease (5.9% vs 28.6%; P = .001). Other comorbidities were comparable between the two groups. The NES patients were more likely to be Medicaid beneficiaries (51.0% vs 21.4%; P < .001). Across all outcomes compared, crude analyses showed no significant difference between NES and ES patients. Adjusted analysis revealed that language discordance did not affect the odds of adverse outcomes of wound infections (odds ratio [OR], 1.87; 95% confidence interval [CI], 0.90-3.88; P = .095), adverse graft events (OR, 1.23; 95% CI, 0.62-2.45; P = .556), readmissions (OR, 1.51; 95% CI, 0.77-2.95; P = .478), or Emergency Department return visits (OR, 1.28; 95% CI, 0.58-2.83; P = .546). CONCLUSIONS: Our study suggests that language discordance does not affect 30-day complication and readmission rates after infrainguinal bypass.

The association of Carotid Revascularization Endarterectomy versus Stent Trial (CREST) and Centers for Medicare and Medicaid Services Carotid Guideline Publication on utilization and outcomes of carotid stenting among "high-risk" patients.

OBJECTIVE: Since the 2004 approval by the United States Food and Drug Administration of carotid artery stenting (CAS), there have been two seminal publications about CAS reimbursement (Centers for Medicare and Medicaid Services guidelines; 2008) and clinical outcomes (Carotid Revascularization Endarterectomy versus Stent Trial [CREST]; 2010). We explored the association between these publications and national trends in CAS use among high-risk symptomatic patients. METHODS: The most recent congruent data sets of the Nationwide Inpatient Sample (NIS) were queried for patients undergoing carotid revascularization. The sample was limited to include only patients who were defined as "high-risk" if they had a Charlson Comorbidity Score of ≥3.0. Subgroup analyses were performed of high-risk patients with symptomatic carotid stenosis. Utilization proportions of CAS were calculated quarterly from 2005 to 2011 for NIS. Three time intervals related to Centers for Medicare and Medicaid Services guidelines and CREST publication were selected: 2005 to 2008, 2008 to 2010, and after 2010. Logistic regression with piecewise linear trend for time was used to estimate different trends in CAS use for the overall high-risk sample and for neurologically asymptomatic and symptomatic cases. Multivariate logistic regression was used to compare odds of postoperative mortality and stroke between these two procedures at different time intervals independent of confounding variables. RESULTS: During the study period, 20,079 carotid endarterectomies (CEAs) and 3447 CAS procedures were performed in high-risk patients in the NIS database. CAS utilization constituted 20.5% of carotid revascularization procedures among high-risk symptomatic patients, with a significant increase from 18.6% to 24.4% during the study period (P < .001). There was an initial increase during 2005 to 2008 in the rate of CAS compared with CEA, CAS utilization significantly decreased during 2008 to 2010 by a 3.3% decline in the odds ratio (OR) of CAS per quarter (OR, 0.967; 95% confidence interval [CI], 0.943-0.993; P = .002), and after CREST (after 2010), CAS utilization continued to increase significantly from the prepublication to the postpublication time interval. The odds of in-hospital mortality (OR, 2.56; 95% CI, 1.17-5.62; P = .019) and postoperative in-hospital stroke (OR, 1.53; 95% CI, 1.09-3.68; P = .024) were independently and significantly higher for CAS patients in the overall sample. CONCLUSIONS: The use of CAS for carotid revascularization in a high-risk cohort of patients has significantly increased from 2005 to 2011. Compared with CEA, CAS independently increased the odds of perioperative in-hospital stroke in all high-risk patients and of in-hospital mortality in symptomatic high-risk patients.

Preoperative hypoalbuminemia is associated with poor clinical outcomes after open and endovascular abdominal aortic aneurysm repair.

OBJECTIVE: The effect of preoperative malnutrition on outcomes in patients undergoing major vascular surgery is unclear. We investigated the effects of preoperative hypoalbuminemia, a marker for malnutrition, on outcomes after open abdominal aortic aneurysm repair (OAR) and endovascular abdominal aortic aneurysm repair (EVAR). METHODS: Patients undergoing OAR or EVAR were identified in the 2005 to 2012 American College of Surgeons National Surgical Quality Improvement Program database and stratified into three groups: normal albumin (serum albumin >3.5 g/dL), moderate hypoalbuminemia (2.8-3.5 g/dL), and severe hypoalbuminemia (<2.8 g/dL). Multivariable analyses were performed to assess the association of preoperative hypoalbuminemia with 30-day morbidity and mortality. RESULTS: We identified 15,002 patients with a recorded preoperative serum albumin who underwent OAR (n = 4956) or EVAR (n = 10,046). Patients in both cohorts with hypoalbuminemia had a higher burden of comorbidity. In OAR patients, multivariable analyses demonstrated that moderate hypoalbuminemia was associated with an increased risk of 30-day mortality (odds ratio [OR], 1.32; 95% confidence interval [CI], 1.02-1.70) and postoperative length of stay (LOS; means ratio [MR], 1.10; 95% CI, 1.04-1.16), whereas severe hypoalbuminemia was associated with increased 30-day mortality (OR, 1.92; 95% CI, 1.37-2.70), reoperation ≤30 days (OR, 1.80; 95% CI, 1.32-2.48), pulmonary complications (OR, 1.40; 95% CI, 1.06-1.86), and postoperative LOS (MR, 1.33; 95% CI, 1.21-1.45). In EVAR patients, moderate hypoalbuminemia was associated with an increased risk of 30-day mortality (OR, 1.90; 95% CI, 1.38-2.62), pulmonary complications (OR, 1.61; 95% CI, 1.26-2.04), reoperation ≤30 days (OR, 1.39; 95% CI, 1.12-1.74), and postoperative LOS (MR, 1.23; 95% CI, 1.18-1.29), whereas severe hypoalbuminemia was associated with increased 30-day mortality (OR, 2.98; 95% CI, 1.96-4.53), pulmonary complications (OR, 1.88; 95% CI, 1.32-2.67), reoperation ≤30 days (OR, 1.54; 95% CI, 1.08-2.19), and postoperative LOS (MR, 1.52; 95% CI, 1.40-1.65). CONCLUSIONS: Preoperative hypoalbuminemia is associated with increased postoperative morbidity and mortality in a severity-dependent manner among patients undergoing OAR or EVAR. Evaluation and optimization of nutritional status should be performed preoperatively in this high-risk population.

Postdischarge Feeding Interactions and Neurodevelopmental Outcome at 1-Year Corrected Gestational Age.

OBJECTIVE: To determine the extent to which postdischarge feeding behaviors and interactions among caregiver-preterm infant dyads are associated with infant neurodevelopment at 1-year corrected gestational age (CGA). STUDY DESIGN: We studied 119 preterm infants born <34 weeks gestation and <1750 g at birth, and their caregivers, enrolled in the Collaborative Home Infant Monitoring Evaluation with in-person feeding assessments according to the Nursing Child Assessment Feeding Scale (NCAFS) at 39-59 weeks postmenstrual age that completed Bayley Scales of Infant Development, Second Edition testing at 1 year CGA. RESULTS: Mean ± SD gestational age was 29.6 ± 2.4 weeks, and birth weight was 1260 ± 320 g. After adjustment for maternal and infant demographics, gestational age at birth, discharge and birth weight, mode of infant feeding, and caregiver type during the postdischarge NCAFS assessment, overall NCAFS scores were positively associated with higher 1-year CGA Bayley mental developmental index (MDI) scores (for each 1 SD increase in overall NCAFS score, MDI increased by 2.8 [95% CI 0.7, 4.9] points). Among individual NCAFS domains, strongest effects were seen for caregiver responsiveness to infant distress, such that, compared with dyads having domain scores of 11 (highest possible score), the adjusted mean difference in MDI was 8.3 points (95% CI -15.2, -1.4) lower among dyads with scores <9. CONCLUSIONS: Caregiver-preterm infant feeding interaction and caregiver responsiveness to preterm infant feeding distress were associated with preterm infant Bayley MDI at 1-year CGA. Caregiver-infant feeding interaction may represent a modifiable factor to improve the neurodevelopment of at-risk preterm infants.

Renal Interstitial Fibrosis: An Imperfect Predictor of Kidney Disease Progression in Some Patient Cohorts.

BACKGROUND: The extent of interstitial fibrosis on kidney biopsy is regarded as a prognostic indicator and guide to treatment. Patients with extensive fibrosis are assigned to supportive treatments with the expectation that they have advanced beyond the point at which immunosuppressive or other disease-modifying therapies would be of benefit. Our study highlights some of the limitations of using interstitial fibrosis to predict who will develop end-stage renal disease (ESRD). METHODS: Analysis of 434 consecutive renal biopsies performed between 2001 and 2012 at a single center. We assessed the influence of various clinical factors along with fibrosis as predictors of ESRD and dialysis-free survival in various patient groups. RESULTS: Interstitial fibrosis performed well overall as a predictor of progression to dialysis. On average, patients with >50% fibrosis progressed more rapidly than those with either 25-49 or 0-24% fibrosis with a median time to dialysis of 1.2, 6.5 and >10 years, respectively. In contrast, interstitial fibrosis was of less value as a predictor of disease progression in a subset of cases that included patients over the age of 70 and those with diabetic nephropathy on biopsy. Surprisingly, 13.9% of patients with normal renal function had 25-49% fibrosis and 5% had more than 50% fibrosis on biopsy, and 5 years after undergoing biopsy 21% of patients with >50% fibrosis still remained dialysis free. CONCLUSION: Renal fibrosis is an imperfect prognostic indicator for the development of ESRD and caution should be exercised in applying it too rigidly, especially in elderly or diabetic patients.

Trust in Sources of Advice about Infant Care Practices: The SAFE Study.

Objectives (1) Determine the prevalence of maternal trust in advice sources on infant care practices; (2) Investigate the association of maternal and infant characteristics with trust in advice sources on infant care practices. Methods Using probability sampling methods, we recruited mothers from 32 U.S. maternity hospitals with oversampling of Black and Hispanic women resulting in a nationally representative sample of mothers of infants aged 2-6 months. Survey questions assessed maternal trust in advice sources (physicians, nurses, family, friends, and media) regarding infant care practices including infant sleep practices (sleep position, bed sharing, and pacifier use), feeding, and vaccination. Weighted frequencies of maternal trust in advice sources were calculated to obtain prevalence estimates. Multivariable logistic regression was used to assess the association of maternal and infant characteristics with maternal trust in advice sources. Results Mothers had the greatest trust in doctors for advice on all infant care practices (56-89 %), while trust was lowest for friends (13-22 %) and the media (10-14 %). In the adjusted analyses, there were significant associations of maternal race/ethnicity, education, and age with trust in advice sources. Conclusions for Practice Maternal trust in advice about infant care practices varied significantly by source. A better understanding of which advice sources are most trusted by mothers, as well as the factors associated with maternal trust, may guide the development of more effective strategies to improve adherence to health promoting infant care practices.

The Association of Publication of Center for Medicaid and Medicare Services Guidelines for Carotid Artery Angioplasty and Stenting (CAS) and CREST Results on the Utilization of CAS in Carotid Revascularization.

BACKGROUND: Since the 2004 approval of carotid artery angioplasty and stenting (CAS), there have been 2 seminal publications about CAS reimbursement (Center for Medicaid and Medicare Several guidelines [CMSG]; 2008) and clinical outcomes (Carotid Revascularization Endarterectomy versus Stent Trial [CREST]; 2010). We explored trends in CAS utilization after these publications nationally. METHODS: The most recent datasets of the nationwide inpatient sample (NIS) was queried for patients undergoing carotid revascularization. Utilization proportions of CAS were calculated quarterly from 2005 to 2011 for NIS. Three-time intervals related to CMSG and CREST publication were selected 2005-2008, 2008-2010, and after 2010. Logistic regression with piecewise linear trend for time was used to estimate different trends in CAS utilization for overall samples and for neurologically asymptomatic and symptomatic cases. RESULTS: The majority (95%) of the carotid revascularizations were performed on asymptomatic patients. Overall, CAS utilization constituted 12.5% of carotid revascularization procedures with a significant period increase of CAS; from 9.4% to 14%; P < 0.001. There was a small but significant decrease in the rate of CAS utilization after CMSG were published corresponding to a 2% decline in the odds ratio (OR) of CAS per quarter (OR, 0.98; 95% confidence interval, 0.97-0.99; P = 0.001). After CREST, CAS utilization continued to increase in both NIS but the rate of increase did not change significantly from the prepublication to the postpublication time interval. The odds of in-hospital mortality and postoperative stroke were independently and significantly higher for CAS patients in both overall and within the symptomatic cohorts. In all 3 periods of the study, and compared to carotid endarterectomy, the odds of mortality and postoperative stroke were significantly higher among patients who underwent CAS. CONCLUSIONS: Although overall utilization of CAS increased since 2005, it was not uniformly associated by the publication of CMSG or CREST. Despite increased utilization, the odds of adverse outcomes were independently higher among CAS patients.