Publications

BACKGROUND: National guidelines recommend forearm arteriovenous fistulas (AVFs) over upper arm AVFs as the initial permanent vascular access for hemodialysis if consistent with the end-stage kidney disease (ESKD) Life-Plan, but comparative outcomes are underexplored. Our objective was to assess longitudinal outcomes of forearm vs upper arm AVFs in patients with advanced kidney disease.

METHODS: Using multicenter data from three prospective studies (Hemodialysis Fistula Maturation [HFM] Study, PATENCY-1 [A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula (AVF) Creation in Patients With Chronic Kidney Disease], and PATENCY-2), we conducted a cohort study of 1516 patients who underwent upper extremity AVF creation (2014-2019). Demographic factors, comorbidities, procedural details, and 3 years of longitudinal follow-up were captured. Outcomes included primary, primary-assisted, and secondary patency at 3 years, successful AVF use, and access-related hand ischemia (ARHI) interventions. Forearm vs upper arm AVF outcomes were compared using Cox regression and logistic regression models. Subgroup analyses included outcomes stratified by site volume using model interaction terms.

RESULTS: The study population included 1059 forearm AVFs and 457 upper arm AVFs; mean age was 56.2 ± 13.4 years and 25.2% were female. The overall primary, primary-assisted, and secondary patency rates at 3 years was 26.2% (95% confidence interval [CI], 23.6%-29.1%), 57.6% (95% CI, 54.6%-60.9%), and 66.5% (95% CI, 63.6%-69.5%), respectively, with no significant differences between forearm and upper arm AVFs. Successful AVF use at 12 months was also similar between forearm (66.1%) and upper arm AVFs (70.0%) (odds ratio, 1.02; 95% CI, 0.71-1.48; P = .91). Forearm AVFs had lower risk of ARHI interventions (hazard ratio [HR], 0.36; 95% CI, 0.18-0.71; P = .003) compared with upper arm AVFs. Subgroup analyses showed that compared with upper arm AVFs, patients who received forearm AVFs at low volume sites (≤30 access creations per year) were at greater risk for loss of primary-assisted (HR, 2.03; 95% CI, 1.21-3.41; P < .001) and secondary patency (HR, 2.53; 95% CI, 1.33-4.83; P < .001). Patients receiving forearm AVFs at low volume sites also had lower AVF use at 12 months (odds ratio, 0.52; 95% CI, 0.21-1.31; P value of interaction = .03).

CONCLUSIONS: Although forearm AVFs demonstrate similar long-term patency and usability as upper arm AVFs, they are associated with lower rates of ARHI. However, outcomes for forearm AVFs seem to have associations with institutional volume-significantly poorer results are seen at low-volume centers. System-level efforts are needed to improve outcomes for forearm AVFs, which serve as a critical lifeline for end-stage kidney disease patients.

OBJECTIVE: This first in human study evaluated the six month angiographic and one year clinical outcomes of a novel thin strut, sirolimus eluting, resorbable scaffold for symptomatic below the knee peripheral arterial disease (PAD). RESOLV I is an international, prospective, multicentre, single arm study assessing the performance of the MAGNITUDE drug eluting resorbable scaffold (DRS) for the treatment of below the knee lesions in patients with symptomatic PAD.

METHODS: Angiographic and duplex ultrasound evaluations were performed by independent core labs at baseline, post-DRS implantation, and at six months follow up. Binary re-stenosis (> 50% diameter stenosis) was determined via quantitative vascular angiography or duplex ultrasound when quantitative vascular angiography was unavailable. Peri-operative death, major adverse limb events, and functional status were evaluated up to one year.

RESULTS: Thirty five patients (mean age 74.5 ± 6.0 years) were enrolled: six (17%) had chronic total occlusion lesions and 25 (71%) had a baseline Rutherford-Becker classification of stage 5. The mean lesion length was 30.1 ± 12.0 mm. The binary re-stenosis rate at six months was 10% (3/31) (angiographic patency of 90%) and mean in segment late lumen loss was 0.75 ± 0.74 mm. Improved Rutherford class at 12 months follow up was achieved in 88% (29/33) of patients and most were asymptomatic (Rutherford-Becker class 0). No amputation or clinically driven target lesion revascularisation events were seen through 12 months.

CONCLUSION: Early results of the RESOLV I study showed that implantation of a thin strut MAGNITUDE DRS achieved low binary re-stenosis rates at six months, as well as improvement in functional status, with no clinically driven target lesion revascularisation at one year.

BACKGROUND: Prompt revascularization is crucial for managing for chronic limb-threatening ischemia (CLTI), but disparities in socioeconomic status (SES) and health care access affect outcomes. The COVID-19 pandemic exacerbated these inequities, yet their impact on CLTI outcomes remains underexplored. This study evaluated the association between regional SES, measured by the Distressed Communities Index (DCI), and outcomes-including mortality, major amputation, and repeat interventions-before, during, and after the COVID-19 pandemic in Medicare beneficiaries undergoing CLTI revascularization.

METHODS: From 2016 to 2023, Medicare beneficiaries undergoing CLTI endovascular revascularization were stratified by SES using the DCI (distressed, ≥80th percentile). The study periods were prepandemic (January 1, 2016, to March 31, 2020), pandemic (March 31, 2020, to December 31, 2021), and late pandemic (December 31, 2021, to December 31, 2023). Metrics were evaluated before and after revascularization. End points were analyzed using Kaplan-Meier and Cox models adjusted for demographics and clinical factors.

RESULTS: Among 333,173 beneficiaries, 66,757 (20.0%) lived in distressed communities, facing higher risks of major amputation and mortality (hazard ratio [HR] 1.04; 95% confidence interval [CI], 1.03-1.05; P < .001). These disparities persisted across the entire study period, including the prepandemic, pandemic, and postpandemic eras. Before the pandemic, risks were elevated (HR, 1.01; 95% CI, 1.00-1.03; P = .125), worsening during the pandemic (HR, 1.06; 95% CI, 1.03-1.09; P < .001) and late pandemic (HR, 1.07; 95% CI, 1.03-1.11; P < .001). The proportion of percutaneous vascular interventions in distressed communities decreased annually (-0.59%; 95% CI, -0.68% to -0.50%; P < .0001). These patients had fewer vascular visits (before, 5.62 vs 6.63; after, 6.52 vs 7.57; P < .001) but more emergency department visits (0.04 vs 0.03; P < .001) and hospital readmissions (0.13 vs 0.11; P < .001).

CONCLUSIONS: Socioeconomic disparities, measured by the DCI, affect outcomes and health care use in Medicare beneficiaries with CLTI undergoing revascularization. These gaps worsened during COVID-19 and persisted after the pandemic, highlighting the need for resources to bridge the care gap and improve CLTI management.

BACKGROUND: Based on the landmark PLATO (Platelet Inhibition and Patient Outcomes) and TRITON-TIMI 38 (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel-Thrombolysis in Myocardial Infarction) trials, current guidelines recommend ticagrelor and prasugrel over clopidogrel for acute coronary syndrome. However, subsequent studies have failed to replicate the reported benefits of ticagrelor, raising concerns about the validity of the PLATO trial's findings.

METHODS: Randomized trials published until January 2025 were searched on PubMed and Embase and included if they compared 2 of the 3 standard dual antiplatelet therapies: 12 months aspirin plus clopidogrel, prasugrel, or ticagrelor. We constructed a network with and without PLATO to assess its impact on the synthesized risk estimates on major adverse cardiovascular events, patient mortality, myocardial infarction, and stent thrombosis, as well as major bleeding and major or minor bleeding.

RESULTS: Twelve trials, enrolling 52 415 patients (clopidogrel: 23 557; ticagrelor: 13 344, prasugrel: 15 514) were included. The analysis with PLATO showed lower hazard ratios for ticagrelor versus clopidogrel than the analysis without PLATO in major adverse cardiovascular events, mortality, myocardial infarction, and bleeding outcomes (e.g., cardiovascular mortality; hazard ratio [HR], 0.83 [95% CI, 0.72-0.96] when PLATO was included; HR, 0.96 [95% CI, 0.73-1.25] when PLATO was excluded). Ticagrelor and prasugrel were associated with higher incidences of major bleeding and major or minor bleeding for analyses including and excluding PLATO, altohugh the point estimates for ticagrelor were lower when PLATO was included.

CONCLUSIONS: The pooled estimates with PLATO favored ticagrelor compared with estimates without PLATO in several studied outcomes, potentially suggesting the substantial impacts of PLATO's findings on the pooled risk estimates; therefore, additional evidence may be needed given the large number of patients worldwide treated with dual antiplatelet therapy.

Renal denervation (RDN) is an interventional approach that targets the sympathetic nervous system with the goal of modulating its activity, an important contributor to the pathogenesis of many cardiovascular and metabolic diseases. Unlike pharmacologic therapies, RDN efficacy is independent of patient adherence to medications, which remains a major limiting factor in long-term blood pressure control. Initially developed to treat severe, treatment-resistant hypertension, RDN has demonstrated consistent results in recent sham-controlled trials across the spectrum of hypertension. As a result, RDN has been incorporated into European guidelines as a treatment option for select patients and endorsed by cardiovascular and hypertension societies worldwide. This review outlines the physiological rationale behind RDN, summarizes the current evidence supporting its effectiveness, provides an overview of the available technologies, and evaluates its emerging role in the treatment of chronic heart failure and other conditions characterized by high sympathetic nervous system activity. Finally, the authors explore future directions, including the concept of multiorgan denervation, which aims to achieve an enhanced degree of sympathetic modulation by targeting additional sympathetic nerves beyond the kidney.

Renal denervation has recently emerged as a novel approach to improving blood pressure control, particularly in patients with uncontrolled or resistant hypertension. Although a substantial body of evidence has accumulated regarding the procedure's efficacy and safety, considerable variation exists across studies in the primary measures used to assess treatment response. The degree of response also differs widely among individuals, highlighting the importance of identifying factors associated with enhanced or limited responses to the procedure. In this review, we summarize the currently available evidence on response parameters and predictors of response to renal denervation and offer perspectives for future research.