Publications by authors named "Kenneth Rosenfield"

Objectives: Diabetes mellitus (DM) is a major risk factor for amputation in patients with chronic limb-threatening ischemia (CLTI) undergoing lower extremity revascularization (LER). Observational studies comparing patients with DM based on insulin therapy have reported inconsistent findings. This study compares the outcomes of patients with insulin-requiring DM (IRDM) and non-insulin requiring DM (NIRDM) based on high quality prospective data.

View Article and Find Full Text PDF

Objective: Multidisciplinary care of chronic limb threatening ischemia (CLTI) through specialized CLTI teams has been associated with improved outcomes, including decreased major amputations. Our goal was to characterize CLTI teams and examine their association with outcomes in the Best Endovascular versus Surgical Therapy in Patients with CLTI (BEST-CLI) trial.

Methods: Responses from a previously described post-trial electronic survey were used to describe CLTI care providers and characterize centers based on the presence of a "formally defined team dedicated to the care of CLTI patients".

View Article and Find Full Text PDF

Background: Catheter-based percutaneous mechanical aspiration (PMA) is an emerging acute intervention for debulking infective vegetations in right-sided infective endocarditis (RSIE); however, its outcomes and safety remain undefined.

Objectives: The authors sought to assess early clinical outcomes and safety of PMA in patients with RSIE.

Methods: The CLEAR-IE (Cardiac Lesion Extraction and Aspiration Registry for Infective Endocarditis) is a large multicenter retrospective registry of consecutive patients with RSIE who have undergone PMA.

View Article and Find Full Text PDF

Balloon pulmonary angioplasty (BPA) was first described in 2001 and now has evolved into a class I indication for inoperable or residual chronic thromboembolic pulmonary hypertension. This review article aims to describe evidence from studies performed at various pulmonary hypertension (PH) centers across the globe, to better understand the role of BPA in chronic thromboembolic pulmonary disease with and without PH. Additionally, we hope to highlight innovations and the ever-changing safety and efficacy profile of BPA.

View Article and Find Full Text PDF

Background: Patients with chronic limb threatening ischemia (CLTI) are at risk for major adverse cardiovascular events (MACE), yet few tools exist for risk stratification.

Objectives: The purpose of this study was to derive and validate a CLTI MACE risk prediction model.

Methods: Participants in the BEST-CLI (Best Endovascular vs.

View Article and Find Full Text PDF

Background: Endovascular revascularization of below-the-knee lesions is a crucial treatment for patients with chronic limb-threatening ischemia (CLTI). However, the optimal approach to revascularizing infrapopliteal arteries remains uncertain. This study aims to compare the safety and efficacy outcomes of various endovascular treatment modalities for infrapopliteal artery disease and provide an evidence-based update through a network meta-analysis.

View Article and Find Full Text PDF

Objective: The results of BEST-CLI trial indicated that, when eligible for both open surgical or endovascular therapy, a single-segment great saphenous vein bypass is the superior revascularization strategy for patients with chronic limb-threatening ischemia (CLTI). Having detailed anatomic information about the burden of arterial occlusive disease is important in understanding the technical difficulty of the cases performed in the trial, and what trial investigators considered equally suitable for either revascularization strategy.

Methods: The BEST-CLI trial, an international multi-site randomized controlled trial (RCT) comparing endovascular with open surgical revascularization in patients who were candidates for both, was analyzed.

View Article and Find Full Text PDF

Objective: Conflicting data exist regarding the benefits of paclitaxel-based endovascular interventions (ENDO-Drug) for patients with chronic limb-threatening ischemia (CLTI). This analysis aims to evaluate the effect of such therapy in the Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial.

Methods: The as treated dataset from the BEST-CLI Trial, a prospective randomized trial comparing surgical and endovascular revascularization for infrainguinal CLTI, was used to assess the association of ENDO-Drug (drug-coated balloons or drug-eluting stents) use and 3-year outcomes after initial technical success in the femoropopliteal (FP) segment.

View Article and Find Full Text PDF

Background: The BEST-CLI (Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia) trial tested the optimal initial revascularization strategy in patients with chronic limb-threatening ischemia. Little is known about the prognostic relevance of Lp(a) (lipoprotein[a]) and its modification by renal function in patients with chronic limb-threatening ischemia. We investigated the relationship between Lp(a) and prespecified cardiovascular outcomes.

View Article and Find Full Text PDF

Importance: Peripheral artery disease (PAD) is a heritable atherosclerotic condition associated with functional decline and high risk for limb loss. With growing knowledge of the genetic basis for PAD and related risk factors, there is potential opportunity to identify individuals at high risk using polygenic risk scores (PRSs).

Objective: To develop a novel integrated, multiancestry polygenic score for PAD (PRS-PAD) and evaluate its risk estimation for PAD and major adverse limb events in 3 populations.

View Article and Find Full Text PDF

Objective: One concern about the endovascular first (ENDO) approach for chronic limb threatening ischaemia (CLTI) is whether bridges are burned for a secondary bypass (SB) if required in the future. This secondary analysis of a prospective randomised trial aimed to compare above ankle amputation rates in patients with CLTI treated with primary bypass (PB) compared with those treated with SB after an initial ENDO approach.

Methods: Data from the randomised unblinded Best Endovascular versus Best Surgical Therapy of Patients with CLTI (BEST-CLI) trial were analysed.

View Article and Find Full Text PDF

Background: The impact of age on outcomes after revascularization for chronic limb-threatening ischemia has not been studied in a prospective trial.

Methods: A total of 1780 patients were grouped into age quartiles (≤55 years, 55< age ≤65 years, 65< age ≤75 years, and >75 years) and by type of revascularization (open bypass or endovascular). The primary outcome was major adverse limb events (MALE) or death, and the secondary outcomes were above-ankle amputation, reintervention, and major adverse cardiovascular events.

View Article and Find Full Text PDF

Background: The optimal strategy for lower extremity revascularization (surgical bypass versus endovascular intervention) in patients with chronic limb-threatening ischemia (CLTI) is unclear. We examined the effectiveness of open surgical bypass using single-segment great saphenous vein conduit (SSGSV), alternative conduits (AC), or endovascular interventions (ENDO) among patients with CLTI deemed acceptable for either open surgical bypass or ENDO treatment.

Methods: This was a planned as-treated analysis of the multicenter BEST-CLI (Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia) randomized controlled trial comparing open surgical bypass and ENDO for CLTI due to infrainguinal peripheral artery disease.

View Article and Find Full Text PDF

Purpose: To analyze the causes and clinical impacts of endovascular technical failure (ETF) in the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb-Threatening Ischemia (BEST-CLI) trial, which compared endovascular therapy with bypass surgery in patients with chronic limb-threatening ischemia (CLTI).

Materials And Methods: Patients with CLTI were randomized to infrainguinal bypass or endovascular therapy. ETF was defined as the inability to complete the endovascular procedure.

View Article and Find Full Text PDF

Objective: Smoking is an established risk factor in many pathologies of the cardiovascular system. The Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial affords an in-depth evaluation into the effect of smoking on patients with chronic limb-threatening ischemia (CLTI). BEST-CLI's prospective, randomized design evaluated outcomes in patients suitable for both open or endovascular intervention and randomized patients between endovascular intervention (ENDO) vs open surgical bypass (OPEN).

View Article and Find Full Text PDF

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.

View Article and Find Full Text PDF

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.

View Article and Find Full Text PDF

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.

View Article and Find Full Text PDF

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.

View Article and Find Full Text PDF
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.
View Article and Find Full Text PDF
Article Synopsis
  • 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.
View Article and Find Full Text PDF

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.

View Article and Find Full Text PDF