Publications by authors named "Rosenfield K"

Background: Chronic limb-threatening ischemia (CLTI) in patients with chronic kidney disease (CKD) has a high risk of poor outcomes. We aimed to compare the outcomes of lower extremity revascularization in patients with CLTI stratified by CKD severity in patients enrolled in the prospective, randomized Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial.

Methods: The BEST-CLI trial dataset was queried to categorize patients into three groups according to CKD stage.

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Background: Atherosclerotic renal artery stenosis (ARAS) may provoke hypertension and/or impaired kidney function. Some patients develop uncontrolled hypertension and deteriorating kidney function despite optimal medical therapy. In these patients, endovascular treatment is an important therapeutic option.

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The clinical presentation and epidemiology of infective endocarditis (IE) have evolved over time. While the cornerstones of IE treatment remain antimicrobial therapy and surgery, percutaneous mechanical aspiration (PMA) has emerged as an option for carefully selected patients as a complementary modality, based on retrospective data, case series, and expert experience. In this comprehensive review, we summarize the proceedings from an inaugural summit dedicated to the discussion of PMA in the global management of IE, consisting of experts across multiple disciplines from diverse geographic regions and care environments.

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Objective: We assessed if age was an effect modifier in a pooled analysis of two randomized trials comparing carotid artery stenting (CAS) and carotid endarterectomy (CEA) in asymptomatic patients, CREST and ACT 1.

Methods: We analyzed data from 2544 patients aged <80 yearas with ≥70% asymptomatic carotid stenosis randomized to CAS or CEA (n = 1091; n = 1453) who were recruited between 2000 and 2013. Age was considered in four strata (<65, 65-69, 70-74, and 75-79 years).

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Objective: Wound, Ischemia, and foot Infection (WIfI) staging was established to provide objective classification in patients with chronic limb-threatening ischemia (CLTI) and to predict 1-year major amputation risk. Our goal was to validate WIfI staging using data from the Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial.

Methods: Data from the BEST-CLI Trial, a prospective randomized trial comparing surgical revascularization (OPEN) and endovascular revascularization (ENDO), were used to assess the association of WIfI stage on long-term outcomes in an intention-to-treat analysis.

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Article Synopsis
  • * In this randomized controlled trial involving 446 patients, the SurVeil PCB showed a primary safety rate of 91.8% and a primary efficacy rate of 82.2%, while the IN.PACT Admiral had rates of 89.8% and 85.9%, respectively.
  • * The results indicate that the SurVeil PCB is a safe and effective treatment option, demonstrating non-inferiority to the IN.PACT Admiral PCB over a 24-month period.
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  • The study aimed to investigate outcomes of female patients with Critical Limb Ischemia (CLI) compared to males in the BEST-CLI trial, particularly focusing on disparities in diagnosis and treatment for peripheral artery disease.
  • It analyzed male and female patients undergoing open surgical bypass or endovascular therapy, assessing outcomes like major amputation, reintervention, and all-cause death, using data from cohorts 1 and 2 of the trial.
  • Results showed that females constituted only 28% of the cohort and had different clinical presentations than males, with females experiencing higher instances of rest pain and fewer adequate vein options for surgical bypass, leading to significant differences in outcomes at one year.
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Objective: Several observational studies have demonstrated an association between diabetes mellitus (DM) and above-ankle amputation after lower extremity revascularization (LER). However, data from prospective randomized trials is lacking. This analysis compares the outcomes of patients with and without DM enrolled in the Best Endovascular vs Best Surgical Therapy in patients with Chronic Limb-Threatening Ischemia (BEST-CLI) trial.

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Objective: Single segment great saphenous vein (SSGSV) traditionally has been considered the gold standard conduit for infrainguinal bypass. There are data supporting similar outcomes with prosthetic femoral-popliteal bypass. Moreover, some investigators have advocated for prosthetic conduit for femoral tibial bypass when GSV is inadequate or unavailable.

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Objectives: To determine if sex was an effect modifier in a pooled analysis of asymptomatic patients from CREST and ACT I.

Materials And Methods: We analyzed data from 2544 patients aged <80 with ≥70 % asymptomatic carotid stenosis randomized to CAS or CEA (n = 1091; n = 1453). The pre-specified primary endpoint in both trials was any stroke, myocardial infarction or death during the peri-procedural period, or ipsilateral stroke within 4 years of randomization.

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Background: Pulmonary embolism (PE) is the third-leading cause of cardiovascular mortality, accounting for 100,000 deaths per year in the United States. Although sex-based disparities have previously been described in this population, it is unclear if these differences have persisted with the expansion of PE evaluation and treatment approaches. The purpose of this study is to investigate sex-based differences in the evaluation, management, and outcomes of patients with acute PE.

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Recent advances in therapy and the promulgation of multidisciplinary pulmonary embolism teams show great promise to improve management and outcomes of acute pulmonary embolism (PE). However, the absence of randomized evidence and lack of consensus leads to tremendous variations in treatment and compromises the wide implementation of new innovations. Moreover, the changing landscape of health care, where quality, cost, and accountability are increasingly relevant, dictates that a broad spectrum of outcomes of care must be routinely monitored to fully capture the impact of modern PE treatment.

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Article Synopsis
  • Catheter-based treatments are becoming important for both acute and chronic pulmonary blood clots, making it essential to understand the anatomy of pulmonary arterial branches.* -
  • A study of 179 patients undergoing angiography showed a variety of branching patterns in the pulmonary arteries, with a total of 7 patterns in the right upper lobe, 3 in the right middle lobe, and so on across the left lobes.* -
  • Notably, only 2-3 branching patterns per lobe were responsible for over 90% of the observed variations, offering valuable insights for medical professionals and future research in pulmonary interventions.*
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In recent years, there has been a shift in the epidemiology of patients with infective endocarditis (IE). This has been characterized by an alarming increase in IE in patients who inject drugs, cardiac implantable electronic device-related IE, and those with comorbid conditions and high surgical risk. This unmet need has mandated a reevaluation of complex management strategies in these patients and introduction of unconventional approaches in treatment.

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Objective: Sustained clinical and hemodynamic benefit after revascularization for chronic limb-threatening ischemia (CLTI) is needed to resolve symptoms and prevent limb loss. We sought to compare rates of clinical and hemodynamic failure as well as resolution of initial and prevention of recurrent CLTI after endovascular (ENDO) vs bypass (OPEN) revascularization in the Best-Endovascular-versus-best-Surgical-Therapy-in-patients-with-CLTI (BEST-CLI) trial.

Methods: As planned secondary analyses of the BEST-CLI trial, we examined the rates of (1) clinical failure (a composite of all-cause death, above-ankle amputation, major reintervention, and degradation of WIfI stage); (2) hemodynamic failure (a composite of above-ankle amputation, major and minor reintervention to maintain index limb patency, failure to an initial increase or a subsequent decrease in ankle brachial index of 0.

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Venous thromboembolism, commonly presented as pulmonary embolism and deep-vein thrombosis, is a paramount and potentially fatal condition with variable clinical presentation. Diagnosis is key to providing appropriate treatment in a safe and timely fashion. Clinical judgment and assessment using clinical scoring systems should guide diagnostic testing, including laboratory and imaging modalities, for optimal results and to avoid unnecessary testing.

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Objective: BEST-CLI, an international randomised trial, compared an initial strategy of bypass surgery with endovascular treatment in chronic limb threatening ischaemia (CLTI). In this substudy, overall amputation rates and risk of major amputation as an initial or subsequent outcome were evaluated.

Methods: A total of 1 830 patients were randomised to receive surgical or endovascular treatment in two parallel cohorts: patients with adequate single segment great saphenous vein (SSGSV) (n = 1 434) were assigned to cohort 1; and patients without adequate SSGSV (n = 396) were assigned to cohort 2.

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Article Synopsis
  • Two studies, BEST-CLI and BASIL-2, looked at different surgeries for patients with serious leg circulation problems and found mixed results.
  • The analysis focused on patients from BEST-CLI who had severe leg issues and underwent either open bypass surgery or a less invasive method.
  • Results showed that the surgical group had fewer major limb problems and needed fewer follow-up surgeries compared to the endovascular group, but death rates were similar for both groups.
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  • The BEST-CLI trial studied two ways to treat a serious blood flow problem called CLTI using surgery and special tubes (endovascular).
  • The researchers looked at serious bad events related to the heart and blood vessels that happened within 30 days after the treatment.
  • They found that both types of treatments had similar rates of heart-related problems, but the endovascular method had a slightly higher rate of blood vessel problems.
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Background: In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL).

Methods: Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein.

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Balloon pulmonary angioplasty continues to gain traction as a treatment option for patients with chronic thromboembolic pulmonary disease with and without pulmonary hypertension. Recent European Society of Cardiology guidelines on pulmonary hypertension now give balloon pulmonary angioplasty a Class 1 recommendation for inoperable and residual chronic thromboembolic pulmonary hypertension. Not surprisingly, chronic thromboembolic pulmonary hypertension centers are rapidly initiating balloon pulmonary angioplasty programs.

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  • A recent study evaluated the effectiveness of second-generation carotid stents (SGS) compared to traditional single-layer stents and carotid endarterectomy (CEA), finding that SGS can lead to better outcomes in certain cases.
  • Data from over 100,000 patients indicated that specific SGS designs, like Casper/Roadsaver and CGuard, significantly reduced the risk of death, stroke, and myocardial infarction compared to CEA, while Gore stent outcomes were generally poorer.
  • Overall, the findings suggest that certain SGS types may offer advantages over CEA, but the performance varies by stent design, highlighting the need for cautious interpretation and consideration of individual patient circumstances.
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Objectives: Patients undergoing revascularization for chronic limb-threatening ischemia experience a high burden of target limb reinterventions. We analyzed data from the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) randomized trial comparing initial open bypass (OPEN) and endovascular (ENDO) treatment strategies, with a focus on reintervention-related study endpoints.

Methods: In a planned secondary analysis, we examined the rates of major reintervention, any reintervention, and the composite of any reintervention, amputation, or death by intention-to-treat assignment in both trial cohorts (cohort 1 with suitable single-segment great saphenous vein [SSGSV], n = 1434; cohort 2 lacking suitable SSGSV, n = 396).

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Aims: Catheter-directed treatment (CDT) of acute pulmonary embolism (PE) is entering a growth phase in Europe following a steady increase in the USA in the past decade, but the potential economic impact on European healthcare systems remains unknown.

Methods And Results: We built two statistical models for the monthly trend of proportion of CDT among patients with severe (intermediate- or high-risk) PE in the USA. The conservative model was based on admission data from the National Inpatient Sample (NIS) 2016-20 and the model reflecting increasing access to advanced treatment from the PERT™ national quality assurance database registry 2018-21.

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