Publications

Most of the 800 000 people living with end-stage kidney disease in the United States rely on a functioning vascular access to provide life-sustaining hemodialysis, yet one-third of arteriovenous fistulas experience early failures. Determining the safety and effectiveness of systemic heparin during fistula creation could improve the quality and quantity of life for these vulnerable patients. In this article, a pragmatic randomized trial was emulated to assess the effect of systemic heparin administration (vs none) during radiocephalic arteriovenous fistula creation on early bleeding and thrombosis, using data from 2 international, multicenter, randomized trials performed between 2014 and 2019. Marginal risks were estimated using inverse probability weighted parametric survival analysis and CIs were generated with bootstrapping. A total of 914 patients were enrolled and 61% received systemic heparin; their median (IQR) age was 58 (49, 67) years and 45% were on hemodialysis at enrollment. No difference in the risk of bleeding events was observed, with a risk difference (95% CI) at 14 days of -0.1% (-1.6 to 1.4). The risk of access thrombosis was lower in the heparin group, with a risk of 3.7% (2.6-4.8) after heparin and 5.3% (3.4-7.4) without heparin at 14 days (risk ratio = 0.72; 95% CI, 0.50-0.98). Trial registration: ClinicalTrials.gov. Identifiers: NCT02110901 and NCT02414841.

A global treatment algorithm was developed for the endovascular revascularization of femoropopliteal lesions and chronic total occlusions, aiming toward a more standardized approach to endovascular treatment in patients with peripheral artery disease. The following steps are proposed. 1) Evaluation of lesion morphology based on preprocedural imaging by Duplex sonography and intravenous ultrasound for selection of lesion preparation tools. Lesion characteristics are mainly defined by calcification, lesion length, and the presence of total occlusion and in-stent restenosis. 2) Selection of vessel preparation strategies, which encompass plain old balloon angioplasty, atherectomy, thrombectomy, intravascular lithotripsy and specialty balloons, or a combination of the preceding, based on lesion and patient-specific characteristics. In addition, a Delphi consensus was applied for the appropriateness of lesion preparation strategies, depending on lesion anatomy, length, plaque morphology, and subintimal versus intraluminal guidewire crossing. 3) Definitive lesion treatment strategies using drug-coated balloons, bare-metal stents, drug-eluting stents, and/or covered stents or a combination. By establishing this treatment algorithm in routine practice, improvements in vessel- and patient-specific outcomes are anticipated, which will be further enhanced by continuous collaboration among experts from different countries and disciplines and by randomized controlled trials.

OBJECTIVE: Routine imaging surveillance following endovascular aortic aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) is critical for the timely diagnosis of late postoperative complications. Compliance with recommended EVAR surveillance is variable, and disparities in post-EVAR surveillance remain unclear. This study examines variability in EVAR surveillance and emergency health service use across several sociodemographic populations.

METHODS: All Medicare fee-for-service beneficiaries who underwent infrarenal EVAR for intact abdominal aortic aneurysm between January 2011 and December 2019 were included. Patients were stratified by several sociodemographic characteristics: age category (66-74, 75-84, >85 years), sex (male, female), race (White, Black, Asian, other), dual enrollment in Medicare and Medicaid (dual enrolled, Medicare only), and distressed communities index (distressed >80th percentile, nondistressed ≤80th percentile). The following postoperative health care use metrics were assessed: EVAR-related office visits, imaging studies, emergency department (ED) visits, and hospital readmissions. Annual incidence rates were calculated for each health care use metric at 2 and 5 years after EVAR and compared across groups using Poisson regression models, adjusting for sociodemographic and hospital characteristics and comorbidities.

RESULTS: In 111,381 Medicare beneficiaries who underwent EVAR, postoperative health care use varied substantially across sociodemographic groups. After adjustment, annual incidence rates of EVAR-related office visits at 2 years post EVAR were lower in patients who were >85 years vs 66-75 years (adjusted rate ratio [aRR], 0.95; 95% confidence interval [CI], 0.93-0.97), female vs male (aRR, 0.94; 95% CI, 0.93-0.95), dual enrolled vs Medicare only (aRR, 0.83; 95% CI, 0.81-0.85), and residing in distressed vs nondistressed communities (aRR, 0.95; 95% CI, 0.93-0.96). Rates of imaging studies were lower in patients who were >85 years (aRR, 0.98; 95% CI, 0.96-0.99), dual enrolled (0.97; 95% CI, 0.95-0.98), and residing in distressed communities (aRR, 0.97; 95% CI, 0.96-0.98). There was higher use of hospital services in patients who were >85 years (ED: aRR, 1.37; 95% CI, 1.33-1.41; readmission: aRR, 1.23; 95% CI,1.19, 1.28), female (ED: aRR, 1.19; 95% CI, 1.16-1.22; readmission: aRR, 1.15; 95% CI, 1.12-1.19), Black (ED: aRR, 1.10; 95% CI, 1.05-1.15; readmission: aRR, 1.15; 95% CI, 1.09-1.22), dual-enrolled (ED: 1.29; aRR, 95% CI, 1.26-1.33; readmission: aRR, 1.14; 95% CI, 1.09-1.18), and residing in distressed communities (ED: aRR, 1.03; 95% CI, 1.01-1.06; readmission: aRR, 1.02; 95% CI, 0.99-1.05). At 5 years post EVAR, similar trends across sociodemographic groups were observed, with the added finding of lower rates of EVAR-related office visits in Black vs White patients.

CONCLUSIONS: Significant variation in post-EVAR health care use exists among Medicare beneficiaries. Patients who were older age, of female sex, of Black race, or socioeconomically disadvantaged had lower rates of EVAR-specific follow-up and higher use of emergency health service. Barriers in access to care are apparent, underscoring the need for targeted interventions to enhance post-EVAR surveillance and improve outcomes in these populations.

BACKGROUND: Staphylococcus aureus bacteremia in patients with cardiac implantable electronic devices (CIED) is often associated with infective endocarditis (CIED-IE). The CIED-IE diagnosis is syndromic. Diagnostic uncertainty is common. Frequently, these patients are classified possible CIED-IE, resulting in guideline non-compliant treatment and heterogeneous outcomes. Improved outcomes require accurate diagnoses. In these patients, we evaluated whether metagenomic sequencing of microbial cell-free DNA (mcfDNA) in serial plasma specimens could improve diagnostic precision.

METHODS: We studied 16 patients with staphylococcal bacteremia who were classified definite or possible CIED-IE and recommended for device removal, if there was a positive blood culture within 7 days and no concurrent deep infection. Plasma specimens obtained at consent, before extraction, and during 96 hours after extraction underwent metagenomic sequencing and quantification of staphylococcal mcfDNA.

RESULTS: In 10 of 11 definite CIED-IE patients, mcfDNA persisted during antibiotic therapy for prolonged durations (median 11 days, IQR 7.5 days [7.5,15]). In these cases, mcfDNA concentration in plasma obtained early after lead extraction increased significantly and thereafter decreased rapidly. In 5 cases of possible CIED-IE, mcfDNA was undetectable after 6 days (IQR 2 days [5.5,7.5]) of antibiotic therapy and remained undetectable after CIED extraction. These mcfDNA patterns differ significantly (p=0.001), suggesting two distinct patient populations: one with definite CIED-IE and one without lead infection.

CONCLUSIONS: If confirmed, these mcfDNA patterns can serve as biomarkers, together with clinical features, to improve precision in diagnosing or rejecting S. aureus CIED-IE. Strategically timed mcfDNA testing before and after CIED extraction may aid in planning therapy.

BACKGROUND: Endovascular technologies continue to evolve to meet the large and growing burden of peripheral arterial disease. The overall quality of published RCTs in endovascular treatments for peripheral arterial disease is low, resulting in uncertainty over treatment effectiveness. The aim of this study was to develop a framework to improve the design, conduct, and reporting of future clinical trials for infrainguinal endovascular treatments of peripheral arterial disease.

METHODS: The authors undertook the design, development, and pilot testing of a novel framework. The study comprised four distinct phases. Phase 1 represented the development of a preliminary framework using content analysis of endovascular interventions described in previously published RCTs. Phase 2 consisted of focus groups with key stakeholders to further develop, revise, and achieve initial consensus on the framework. Phase 3 corresponded to the creation of a modified Delphi questionnaire to achieve final consensus on the framework. Phase 4 included cognitive interviews with professionals designing or undertaking endovascular lower limb trials to pilot test the framework.

RESULTS: Content analysis of 228 endovascular interventions from 112 RCTs identified six key themes, relevant to endovascular peripheral arterial disease interventions, for the framework: expertise; setting; anaesthesia; imaging; intervention components (access; crossing lesion; treating lesion (lesion preparation; intervention; intervention optimization; bailout intervention; and treatment of non-target lesions); and closure of artery); and pharmacological interventions. Further refinements were made to the framework as a result of feedback from three focus groups and a Delphi questionnaire. The framework deconstructs an endovascular intervention into its component parts. The final framework can be accessed at www.endo-star.com. Pilot testing evaluated comprehension, clarity, and completeness of interpretation.

CONCLUSION: The Endo-STAR framework deconstructs endovascular interventions into their key component parts and has been designed and pilot tested to enhance the quality of RCTs of endovascular interventions in peripheral arterial disease. It may be used to assist in developing future trial protocols, the standardization of infrainguinal endovascular interventions, the monitoring of adherence to the trial protocol, and as a standardized reporting guideline.