Publications by Year: 2025

Carotid artery revascularization plays an important role in stroke prevention among patients with carotid stenosis. While carotid endarterectomy has been the mainstay of revascularization in those with moderate to severe stenosis, the evolution of carotid artery stenting and the recent expansion of Medicare coverage have impacted utilization trends and guideline recommendations. We aim to review currently available data on revascularization techniques, discuss important factors influencing treatment decisions, and explore future directions of carotid stenosis management.

PURPOSE OF REVIEW: This review provides a practical, evidence-based summary of the physiology, major trial data and clinical role of renal denervation in the treatment of hypertension.

RECENT FINDINGS: The cornerstone of hypertension therapy remains anti-hypertensive medications although this strategy has significant limitations with poor rates of blood pressure control for most patients. Renal denervation was designed to bypass concerns about medication adherence and provide an "always-on" treatment. Recent trial data and meta-analyses are presented demonstrating a modest, although heterogeneous, response to renal denervation which led to the treatment's recent FDA approval. Improvements in catheter design and renal artery treatment strategy may underlie the improved clinical response to denervation in more recent trials.

SUMMARY: Hypertension centers involving multi-disciplinary care teams are equipped to provide patients with advanced diagnostic testing for secondary hypertension, comprehensive non-invasive management strategies and invasive renal denervation to address hypertension. Early referral for patients with uncontrolled hypertension can provide patients with nuanced conservative and interventional options which have the potential to improve hypertension related morbidity and mortality. Future studies are needed to identify which patients are most likely to respond to renal denervation.

Head-to-head research comparing invasive revascularization strategies for chronic limb-threatening ischemia (CLTI) is sparse, partly due to challenges in conducting randomized controlled trials in the CLTI space. These include the expense of head-to-head trials, optimizing patient selection criteria for real-world applicability, and identifying optimal study end points. The Vascular InterVentional Advances (VIVA) Foundation, a 501(c)(3) not-for-profit organization, convened a Vascular Leaders Forum to initiate an open, multispecialty collaborative discussion of these challenges and ways to optimize the design of medical device trials in CLTI. This article summarizes the current landscape of clinical studies of CLTI revascularization strategies and options for designing comparative trials proposed by representatives from vascular surgery, interventional cardiology, interventional radiology, vascular medicine, podiatry, the U.S. Food and Drug Administration, and a medical device manufacturer. Four broad areas to optimize comparative trials of CLTI interventions were identified. First, primary end points should be carefully chosen with attention to clinical, patient-centric, imaging, and hierarchical considerations; standardization; and inclusion of guideline-directed medical therapy. Second, broader eligibility criteria can expand and hasten enrollment and are important for gathering evidence on outcomes in medically complex patients often encountered in real-world practice. Third, extending the primary end point timing to 12 months with additional follow-up out to 24 to 60 months would accommodate a longer period of device evaluation and the ability to enrich clinical end-point rates. Finally, innovative pragmatic trial designs and statistical methodologies are needed to conduct comprehensive, cost effective, relevant trials with sufficient statistical power and without prohibitively large sample sizes and study durations.

Care for patients with chronic limb-threatening ischemia (CLTI) is complex, and it is most effective when conducted with collaboration across multiple specialties. A recent upward trend in major limb amputation among patients with CLTI warrants a renewed effort to optimize care for this multifaceted condition. The Vascular InterVentional Advances (VIVA) Foundation, a not-for-profit 501(c)(3) organization, convened a Vascular Leaders Forum in 2024 to initiate an open, multispecialty discussion about the state of CLTI care in the United States and current challenges around delivery and access to such care. The forum comprised representatives from vascular surgery, interventional cardiology, interventional radiology, vascular medicine, podiatry, regulators, medical device manufacturers, patient advocacy, and the CLTI and CLTI caregiver population. This article explores the central themes of challenges in CLTI care and ways in which collaboration across specialties and care settings could improve CLTI outcomes. In summary, it was recommended that integrated CLTI care teams extend beyond vascular surgery, interventional cardiology, and interventional radiology to include vascular medicine, podiatry, wound care, diabetology, and dietetics. Meeting the increasing demand for CLTI revascularization will require these teams to span tertiary care hospitals, community hospitals, outpatient revascularization clinics, and primary care settings.

OBJECTIVE: External saphenous vein graft stenting has been shown to reduce intimal hyperplasia, lumen irregularities, and flow disturbances after coronary artery bypass grafting (CABG). The objective of this study is to evaluate the effect of saphenous vein graft external stenting on clinical outcomes up to 5 years.

METHODS: Outcomes for patients who received external vein graft stenting in an international, real-world cohort were compared in a propensity matched analysis with patients from the Arterial Revascularization Trial (ISRCTN46552265). All eligible patients required an internal mammary artery graft to the left anterior descending coronary artery, received at least one vein graft, and survived to discharge. The primary end point was major adverse cardiovascular and cerebrovascular events at 1 year after surgery, consisting of all-cause mortality, myocardial infarction, repeat revascularization, and cerebrovascular accident. Secondary end points included 5-year major adverse cardiovascular and cerebrovascular events with and without stroke and annualized target vessel revascularization.

RESULTS: In total, 789 treated and 2205 control patients were included. At 1 year after CABG, the weighted hazard ratio comparing outcomes between treated and control patients was 0.60 (90% confidence interval, 0.38-0.94, P = .03). The benefits associated with external stenting for the composite outcome persisted through 5 years' post-CABG (hazard ratio, 0.70; 95% confidence interval, 0.51-0.98, P = .04). Annual target vessel revascularization rates in vein grafts were significantly lower in the venous external support cohort at 2 to 5 years after surgery (P = .009-.03).

CONCLUSIONS: The current study demonstrates that external vein graft stenting is associated with a significantly lower risk of experiencing adverse clinical outcomes up to 5 years after surgery compared with standard of care.

BACKGROUND: Although atherectomy for peripheral interventions has been studied for over 35 years, recent criticisms suggest it lacks supportive evidence. This analysis provides a comprehensive overview of the quality and outcomes in the published atherectomy literature.

METHODS: A systematic review of original research published in MEDLINE, Embase, and PubMed through November 2024 identified prospective and retrospective studies on atherectomy for infrainguinal peripheral artery interventions. Case studies and meta-analyses were included in the systematic review but excluded from the quantitative meta-analysis. Risk of bias was assessed using validated scales. Study design, device class, patient/lesion characteristics, provisional stenting, distal embolization, and 12-month outcomes (patency, major amputation, target lesion revascularization, and mortality) were captured.

RESULTS: The systematic review included 322 published atherectomy papers (121 directional, 44 laser, 30 orbital, 72 rotational, 55 mixed atherectomy classes). Designs were meta-analyses in 3.7% (12 papers), randomized controlled trials in 5.9% (19 papers), prospective observational studies in 29.8% (96 papers), retrospective observational studies in 45.7% (147 papers), and case studies in 14.9% (48 papers). Adjunctive therapies were used in 91.5%, and 29.2% included a comparator arm. Among 190 papers included in the meta-analysis, the 12-month patency, target lesion revascularization, major amputation, and mortality rates were 75.4% (51 studies), 15.6% (67 studies), 1.7% (71 studies), and 2.8% (63 studies), respectively. The distal embolization rate was 2.2% (159 studies), and the provisional stenting rate was 9.3% (131 studies). Considerable heterogeneity was observed.

CONCLUSIONS: Extensive published literature exists for peripheral atherectomy, including high levels of evidence. Clinical outcomes were overall favorable with low rates of amputation, mortality, provisional stenting, and distal embolization. This intentionally broad review was associated with considerable heterogeneity and should be confirmed with appropriate comparative studies.

BACKGROUND: Chronic limb-threatening ischemia (CLTI) affects over 2 million Americans and carries high risks of amputation and mortality. Use of ambulatory surgical centers (ASCs) and outpatient-based laboratories (OBLs) for revascularization has increased, but outcomes in these settings remain poorly characterized.

OBJECTIVES: The authors sought to evaluate national trends in CLTI revascularization from 2016 to 2023 across clinical settings (hospital-based inpatient, hospital-based outpatient, and ASC/OBL) and compare outcomes of peripheral vascular intervention (PVI) by setting.

METHODS: This retrospective cohort study used Medicare fee-for-service claims data from January 1, 2016, to December 31, 2023, including 925,905 beneficiaries aged ≥66 years undergoing lower extremity PVI for CLTI. Clinical setting of the index procedure was the primary exposure. The primary outcome was a composite of all-cause mortality or major amputation. Secondary outcomes included components of the primary outcome, repeat revascularization, and changes in ambulatory status. Outcomes were analyzed via Kaplan-Meier methods via multivariable Cox regression, adjusting for clinical, sociodemographic, and hospital-level factors.

RESULTS: Of 820,381 total revascularizations, the proportion performed in ASC/OBLs increased to 46.72% by 2023. ASC/OBLs treated a higher proportion of Black patients (18.25%) and dual-eligible beneficiaries (29.94%), whereas hospital inpatient settings treated more patients with gangrene and complex comorbidities. Over a median follow-up of 657 days (Q1-Q3: 204-1,378 days), 188,033 patients (56.4%) experienced the composite of death or major amputation, including 176,140 deaths (52.9%) and 36,743 major amputations (11.0%). Median follow-up for the composite outcome was 413 days (Q1-Q3: 95-1,093 days) after inpatient, 840 days (Q1-Q3: 307-1,579 days) after hospital-based outpatient, and 745 days (Q1-Q3: 285-1,417 days) after ASC/OBL procedures. After multivariable adjustment, ASC/OBLs were associated with lower risk of the primary outcome compared with hospital-based outpatient (HR: 0.93; 95% CI: 0.92-0.94) and inpatient settings (HR: 0.47; 95% CI: 0.45-0.49). However, ASC/OBLs had higher rates of repeat revascularization and similar changes in ambulatory status.

CONCLUSIONS: By 2023, ASC/OBLs emerged as the dominant setting for CLTI revascularization among Medicare beneficiaries. Although ASC/OBLs were associated with improved outcomes, the observational nature of this analysis and residual confounding limit causal conclusions. Rather, the improved outcomes suggest appropriate patient selection has supported the migration of PVI to ambulatory environments.