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Background: Intravascular ultrasound (IVUS) has been shown in limited prospective studies to improve procedural outcomes for patients undergoing lower extremity peripheral arterial intervention (PVI)., Objectives: The authors aimed to study temporal trends, practice variation, and associated outcomes with the use of IVUS during PVI among Medicare beneficiaries., Methods: All PVIs performed from 2016 to 2019 among Medicare beneficiaries aged >65 years were included. Temporal trends in IVUS use were stratified by procedural location (inpatient, outpatient, or ambulatory surgery center [ASC]/office-based laboratory [OBL]) and physician specialty. The primary outcome was major adverse limb events (MALE). Inverse probability weighting was used to account for differences in baseline characteristics. Cox regression with competing risks was used to estimate weighted hazard ratios., Results: During the study period, 543,488 PVIs were included, of which 63,372 (11.7%) used IVUS. A substantial growth in IVUS use was observed, which was driven by procedures performed in ASCs/OBLs (23.6% increase from quarter 1 of 2016 through quarter 4 of 2019). Among operators who used IVUS, there was also notable variation in use (median operator use 5.4% of cases; IQR: 2.2%-15.0%; range, <1%-100%). In weighted analysis, IVUS use during PVI was associated with a lower risk of MALE through a median of 514 days (adjusted hazard ratio: 0.73; 95% CI: 0.70-0.75; P < 0.0001)., Conclusions: In contemporary nationwide data, IVUS use during PVI has increased since 2016, driven by growth in the ASC/OBL setting. However, there remains substantial variation in operator practice. When used during PVI, IVUS was associated with a lower risk of short- and long-term MALE., Competing Interests: Funding Support and Author Disclosures This work was funded by the Smith Center for Outcomes Research in Cardiology, including a research grant from Philips to the Smith Center. Dr Divakaran is supported by a joint KL2/Catalyst Medical Research Investigator Training (CMeRIT) Award from Harvard Catalyst and the Boston Claude D. Pepper Older Americans Independence Center (5P30AG031679-10). Dr Secemsky is supported by National Institutes of Health/NHLBI K23 HL150290 and Harvard Medical School’s Shore Faculty Development Award. Dr Parikh has received research grants from Abbott, Boston Scientific (DSMB), Shockwave, Surmodics, TriReme, and Veryan Medical; has received consulting fees from Abiomed, Inari, Penumbra, and Terumo; and is an advisory board member for Abbott, Boston Scientific, CSI, Janssen, Medtronic, and Philips. Dr Hawkins has received institutional research grants from Behring, Hemostemix, National Institutes of Health/National Heart, Lung, and Blood Institute, and Boston Scientific. Dr Banerjee has received honoraria from Medtronic, Cordis, Livmor, and AngioSafe. Dr Rosenfield has received research grants to his institution from National Institutes of Health and Boston Scientific; has equity in Accolade, Access Vascular, Althea Medical, Contego, Cruzar Systems, Embolitech, Endospan, JanaCare, Magneto, Orchestra, PQ Bypass, Shockwave, Thrombolex, Truvic, and Valcare; is a consultant/has scientific advisory board relationships with Angiodynamics, Boston Scientific, Contego; InspireMD, Magneto, Mayo Clinic, Neptune Medical, Philips, Summa Therapeutics, Surmodics, Thrombolex, and Truvic; and is a board member of the National PERT Consortium. Dr Secemsky has received research grants to Beth Israel Deaconess Medical Center (NIH/NHLBI K23HL150290, Food and Drug Administration, Harvard Medical School’s Shore Faculty Development Award, AstraZeneca, BD, Boston Scientific, Cook, CSI, Laminate Medical, Medtronic, and Philips); and has received consulting fees from Abbott, Bayer, BD, Boston Scientific, Cook, CSI, Endovascular Engineering, Inari, Janssen, Medtronic, Philips, and VentureMed. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

This review details the utility of intravascular ultrasound (IVUS) for the management of peripheral artery and venous disease. The purpose of this document is to provide an update in the use of IVUS in peripheral arterial and venous pathology and demonstrate the use of IVUS as a practical diagnostic imaging procedure to evaluate and treat peripheral vascular disorders. IVUS, a diagnostic tool that relies on sound waves to produce precise images of the vessel being evaluated, was originally introduced to the medical community for the purposes of peripheral artery imaging, though it was quickly adapted for coronary interventions with positive outcomes. The utility of IVUS includes vessel measurement, pre- and post-procedural planning, treatment optimisation, and detection of thrombus, dissection or calcium severity. While angiography remains the standard imaging approach during peripheral intervention, multiple observational studies and small prospective trials have shown that in comparison, IVUS provides more accurate imaging detail, which may improve procedural outcomes. IVUS can also address limitations of angiography, including the need to administer contrast medium and eliminate the ambiguity associated with other forms of imaging. This review provides contemporary examples of where IVUS is being used during peripheral intervention as well as representative imaging to serve as a resource for the practising clinician.

Background: Due to the bleeding risk of full-dose systemic thrombolysis and the lack of major trials focusing on the clinical benefits of catheter-directed treatment, heparin antiocoagulation remains the standard of care for patients with intermediate-high-risk pulmonary embolism (PE)., Methods and Results: The Higher-Risk Pulmonary Embolism Thrombolysis (HI-PEITHO) study (ClinicalTrials.gov Identifier: NCT04790370) is a multinational multicenter randomized controlled parallel-group comparison trial. Patients with: (1) confirmed acute PE; (2) evidence of right ventricular (RV) dysfunction on imaging; (3) a positive cardiac troponin test; and (4) clinical criteria indicating an elevated risk of early death or imminent hemodynamic collapse, will be randomized 1:1 to treatment with a standardized protocol of ultrasound-facilitated catheter-directed thrombolysis plus anticoagulation, vs anticoagulation alone. The primary outcome is a composite of PE-related mortality, cardiorespiratory decompensation or collapse, or non-fatal symptomatic and objectively confirmed PE recurrence, within 7 days of randomization. Further assessments cover, apart from bleeding complications, a broad spectrum of functional and patient-reported outcomes including quality of life indicators, functional status and the utilization of health care resources over a 12-month follow-up period. The trial plans to include 406 patients, but the adaptive design permits a sample size increase depending on the results of the predefined interim analysis. As of May 11, 2022, 27 subjects have been enrolled. The trial is funded by Boston Scientific Corporation and through collaborative research agreements with University of Mainz and The PERT Consortium., Conclusions: Regardless of the outcome, HI-PEITHO will establish the first-line treatment in intermediate-high risk PE patients with imminent hemodynamic collapse. The trial is expected to inform international guidelines and set the standard for evaluation of catheter-directed reperfusion options in the future., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Single-cohort studies suggest that second-generation stents (SGS; “mesh stents”) may improve carotid artery stenting (CAS) outcomes by limiting peri- and postprocedural cerebral embolism. SGS differ in the stent frame construction, mesh material, and design, as well as in mesh-to-frame position (inside/outside). Objectives: To compare clinical outcomes of SGS in relation to first-generation stents (FGSs; single-layer) in CAS. Methods: We performed a systematic review and meta-analysis of clinical studies with FGSs and SGS (PRISMA methodology, 3302 records). Endpoints were 30-day death, stroke, myocardial infarction (DSM), and 12-month ipsilateral stroke (IS) and restenosis (ISR). A random-effect model was applied. Results: Data of 68,422 patients from 112 eligible studies (68.2% men, 44.9% symptomatic) were meta-analyzed. Thirty-day DSM was 1.30% vs. 4.11% (p < 0.01, data for SGS vs. FGS). Among SGS, both Casper/Roadsaver and CGuard reduced 30-day DSM (by 2.78 and 3.03 absolute percent, p = 0.02 and p < 0.001), whereas the Gore stent was neutral. SGSs significantly improved outcomes compared with closed-cell FGS (30-day stroke 0.6% vs. 2.32%, p = 0.014; DSM 1.3% vs. 3.15%, p < 0.01). At 12 months, in relation to FGS, Casper/Roadsaver reduced IS (−3.25%, p < 0.05) but increased ISR (+3.19%, p = 0.04), CGuard showed a reduction in both IS and ISR (−3.13%, −3.63%; p = 0.01, p < 0.01), whereas the Gore stent was neutral. Conclusions: Pooled SGS use was associated with improved short- and long-term clinical results of CAS. Individual SGS types, however, differed significantly in their outcomes, indicating a lack of a “mesh stent” class effect. Findings from this meta-analysis may provide clinically relevant information in anticipation of large-scale randomized trials., Competing Interests: Kenneth Rosenfield reports receiving fees for serving on advisory boards from Abbott Vascular, Cardinal Health, Surmodics, Inari Medical, Volcano/Philips, and Proteon; receiving fees and stock options for serving on advisory boards from Cruzar Systems, Valcare, and Eximo; receiving stock options for serving on advisory boards from Capture Vascular, Shockwave, Micell, Endospan, and Silk Road Vascular; receiving stock options for serving on the advisory boards of and the holding of equity positions in Contego, Access Vascular, and MD Insider; holding stock/stock options in Embolitech, Janacare, Primacea, and PQ Bypass; receipt of a future payout from a previous equity position in Vortex; and receiving grant support paid to his institution from Abbott Vascular, Atrium/Maquet, and Lutonix/Bard. David Christopher Metzger is Co- Principal Investigator in the CGUARDIANS FDA-IDE Trial. Adnan H. Siddiqui has consulted for Amnis Therapeutics Ltd, Cerebrotech Medical, Systems Inc, CereVasc LLC, Claret Medical Inc, Codman, Corindus Inc, GuidePoint Global Consulting, Medtronic (Formerly Covidien), MicroVention, Neuravi, Penumbra, Pulsar Vascular, Rapid Medical, Rebound Therapeutics Corporation, Silk Road Medical, Stryker, The Stroke Project Inc, Three Rivers Medical Inc, W.L. Gore & Associates, and is a Board Member of Intersocietal Accreditation Commission. He has been Principal Investigator and/or served on Steering Committees for: Codman & Shurtleff, LARGE Trial, Covidien (Now Medtronic), SWIFT PRIME and SWIFT DIRECT Trials; MicroVention, FRED Trial, CONFIDENCE Study, MUSC, POSITIVE Trial; Penumbra, 3D Separator Trial, COMPASS Trial, INVEST Trial. AHS has financial interests in BuffaloTechnology Partners Inc, Cardinal, International Medical Distribution Partners, Medina Medical Systems, Neuro Technology Investors, StimMed, and Valor Medical. Piotr Pieniazek has proctored and/or consulted for Terumo, Boston Scientific and Balton. Joachim Schofer has been Co-Principal Investigator in the CARENET Trial. Andrej Schmidt has consulted for Abbott Vascular, BD, Cook and Medtronic. Piotr Musialek has proctored and/or consulted for Abbott Vascular, InspireMD, and Medtronic. PM is Co- Principal Investigator in the CGUARDIANS FDA-IDE Trial and has been Co-Principal Investigator in the CARENET Trial; he is Principal Investigator in a series of Investigator-Initiated studies including PARADIGM/PARADIGM-Extend (NCT04271033), FLOW-GUARD (NCT04461717), OPTIMA (NCT04234854), TOP-GUARD (NCT0454738), C-HEAL (NCT04434456), SIM-GUARD (NCT04973579) and SAFEGUARD-STROKE (NCT05195658). PM is the Polish Cardiac Society Board Representative for Stroke and Vascular Interventions and serves on the European Society of Cardiology (ESC) Stroke Council Scientific Documents Task Force and on ESC Research and Grants Committee. Other author declare no conflict of interest.

Balloon pulmonary angioplasty (BPA) is an evolving treatment modality for patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are not candidates for pulmonary endarterectomy. Although several imaging modalities currently exist for evaluating CTEPH, their individual use, specifically in the clinical practice of BPA, has not been well described. In this article, we provide a preprocedural, intraprocedural, and postprocedural interventional imaging roadmap for safe and effective BPA performance in routine clinical practice. Preprocedural assessment includes transthoracic echocardiography for right ventricular assessment, ventilation/perfusion scan to identify pulmonary segments with the highest degree of hypoperfusion, cross-sectional chest imaging excluding alternative causes of mismatched defects and providing anatomic and perfusion imaging concurrently, and nonselective invasive pulmonary angiography for risk stratification of individual lesion subtypes. Intraprocedural assessment includes subselective segmental angiography (SSA) for delineating segmental and subsegmental branch anatomy, lesion identification, and vessel sizing. Intravascular ultrasound and optical coherence tomography serve as adjunctive intraprocedural tools for more accurate vessel sizing and lesion characterization when SSA alone is insufficient. Postprocedural considerations include chest radiography to monitor for immediate postprocedure complications and echocardiography for the interval assessment of the right ventricle on longer-term follow-up., (© 2022 The Authors.)

Background: There has been growing use of intravascular ultrasound (IVUS) during lower extremity arterial and venous revascularization. Observational data suggest that the use of IVUS can improve periprocedural and long-term outcomes, but largescale prospective data remain limited. Consensus opinion regarding the appropriate use of IVUS during peripheral intervention is needed., Objectives: The purpose of this consensus document is to provide guidance on the appropriate use of IVUS in various phases of peripheral arterial and venous interventions., Methods: A 12-member writing committee was convened to derive consensus regarding the appropriate clinical scenarios for use of peripheral IVUS. The group iteratively created a 72-question survey representing 12 lower extremity arterial interventional scenarios. Separately, a 40-question survey representing 8 iliofemoral venous interventional scenarios was constructed. Clinical scenarios were categorized by interventional phases: preintervention, intraprocedure, and postintervention optimization. Thirty international vascular experts (15 for each survey) anonymously completed the survey instrument. Results were categorized by appropriateness using the median value and disseminated to the voting panel to reevaluate for any disagreement., Results: Consensus opinion concluded that IVUS use may be appropriate during the preintervention phase for evaluating the etiology of vessel occlusion and plaque morphology in the iliac and femoropopliteal arteries. IVUS was otherwise rated as appropriate during iliac and femoropopliteal revascularization in most other preintervention scenarios, as well as intraprocedural and postprocedural optimization phases. IVUS was rated appropriate in all interventional phases for the tibial arteries. For iliofemoral venous interventions, IVUS was rated as appropriate in all interventional phases., Conclusions: Expert consensus can help define clinical procedural scenarios in which peripheral IVUS may have value during lower extremity arterial and venous intervention while additional prospective data are collected., Competing Interests: Funding Support and Author Disclosures Dr Secemsky is funded in part by National Institutes of Health/National Heart, Lung, and Blood Institute grant K23HL150290. This review was funded in part by unrestricted educational grants from Boston Scientific and Philips IGT. These companies have not seen or participated in the creation of this manuscript, including no contribution in the writing of the manuscript, significant edits, or the decision whether to submit. Dr Secemsky is a consultant and Speakers Bureau and/or advisory board member for Abbott, Bayer, Becton, Dickinson and Company, Boston Scientific, Cook, Cardiovascular Systems, Inc., Endovascular Engineering, Inari, Janssen, Medtronic, Philips, and VentureMed; has received grants to the institution from the National Institutes of Health/National Heart, Lung, and Blood Institute (K23HL150290), the U.S. Food and Drug Administration, Harvard Medical School (Shore Faculty Development Award), AstraZeneca, BD, Boston Scientific, Cook, Cardiovascular Systems, Inc., Laminate Medical, Medtronic, and Philips. Dr Kohi is a board member at VIVA Physicians; and is a global principal investigator of the ELEGANCE (Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature) registry with Boston Scientific but is not being personally compensated. Dr Rosenfield is a consultant and scientific advisory board member for Angiodynamics, Boston Scientific, Contego, InspireMD, Magneto, Mayo Clinic, Neptune Medical, Philips, Summa Therapeutics, Surmodics, Thrombolex, and Truvic; has received grants to the institution from the National Institutes of Health and Boston Scientific; holds equity in Accolade, Access Vascular, Althea Medical, Contego, Cruzar Systems, Embolitech, Endospan, JanaCare, Magneto, Orchestra, PQ Bypass, Shockwave, Thrombolex, Truvic, and Valcare; and is a board member for the National PERT Consortium, a not-for-profit 501(c)(3) organization dedicated to advancing treatment and improving outcomes in pulmonary embolism. Dr Lichtenberg has received honoraria for lectures from Cagent Vascular, CR Bard, Boston Scientific, AB Medica, Philips, Terumo, Biotronik, Veryan, and Medtronic; has received honoraria for advisory board activities from Cagent Vascular, Biotronik, Veryan, Boston Scientific, Philips, Soundbite, Limflow, Covellus, and Medtronic; has participated in clinical trials for Cagent Vascular, Biotronik, CR Bard, Verya, Boston Scientific, LimFlow, Terumo, and Philips; and has received research funding from Cagent Vascular, Biotronik, Boston Scientific, Veryan, plusMedica, Philips, and CR Bard. Dr Meissner has served as a consultant for Cook Medical for a project using a Delphi consensus panel for venous stenting; Dr Varcoe consults for Medtronic, Abbott, BD Bard, Philips Healthcare, Intervene, and Surmodics; Dr Holden is a medical advisory board member for Medtronic, Gore, and Boston Scientific; and is a clinical investigator for Bard/BD, Boston Scientific, Cagent Medical, Cook Medical, Endologix, Endospan, Gore Medical, Intact Vascular, Medtronic, Philips, Reflow Medical, Shockwave Medical, and TriReme Medical. Dr Jaff is a part-time employee at Boston Scientific; is a consultant at Glide Healthcare; and holds equity investments in R3 Vascular, Nectero, Vactronix, and EFemoral. Dr Chalyan is an employee at Philips IGT. Dr Clair discloses his involvement with Boston Scientific, Elastimed, Endologix, and Medtronic and clarifies that he does not receive any income from these relationships, as all the income goes to the organization by which he is employed; and serves as a data and safety monitoring board member for Bard/Becton, Dickinson and Company and Boston Scientific (all income goes to the medical group). Dr Hawkins is a consultant at Baim; and conducts institutional research at Behring, Hemostemix, and the National Institutes of Health/National Heart, Lung, and Blood Institute. Dr Parikh is an advisory board member for Abbott, Boston Scientific, Medtronic, Philips, and Cordis; has conducted research for Abbott, Boston Scientific (data and safety monitoring board), Shockwave, Surmodics, TriReme, Veryan Medical, Acotec, and MedAlliance; and is a consultant for Abiomed, Canon, Inari, Penumbra, and Terumo. Dr Mosarla has reported that she has no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Although angiography has been the primary imaging modality used in peripheral vascular intervention, this technique has major limitations due to the evaluation of three-dimensional vessels in two dimensions. Intravascular ultrasound (IVUS) is an important adjunctive tool that can address some of these limitations. This systematic review assesses the appropriateness of IVUS as an imaging modality for guiding peripheral intervention through evidence collection and clinical appraisal of studies. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a cohort of 48 studies (29 arterial; 19 venous) detailing IVUS use in peripheral vascular intervention were extracted. Qualitative assessment of the studies evaluated pre- and postprocedure efficacy of IVUS and revealed that IVUS-guided peripheral intervention in arterial and venous diagnosis and treatment was superior to other imaging techniques alone. Each study in the cohort was further assessed for reliability and validity using the Oxford Centre for Evidence Based Medicine (CEBM) level of evidence scale. The majority of both arterial (79.3%) and venous (73.7%) studies received a 2b rating, the second highest level of evidence rating. The evidence to date indicates that IVUS results in better clinical outcomes overall and should be more widely adopted as an adjunctive imaging modality during peripheral intervention. (PROSPERO Registration No.: CRD42021232353) .

Significant advances in the field of carotid artery stenting (CAS) have occurred, including new randomized trial data, recent professional societal statements for competency, new techniques and new devices that have been developed, and perhaps most importantly, our understanding of how to better select candidates for CAS to avoid periprocedural complications. The current Centers for Medicare and Medicaid Services coverage decision regarding CAS is outdated, and our review supports our recommendation to approve CAS in selected candidates who are symptomatic with a carotid stenosis ≥50% and ≤99% and for asymptomatic patients with carotid stenosis ≥70% and ≤99% for stroke prevention. Optimized CAS strategies have allowed experienced operators to better assess procedure risk before CAS and have led to continued improvement in CAS outcomes. New technologies including enhanced embolic protection devices and dual-layered stents should result in further improvement., Competing Interests: Funding Support and Author Disclosures Dr Siddiqui is supported by National Institutes of Health/National Institute of Neurological Disorders and Stroke (co-investigator, Grant No. 1R01NS091075 [Virtual Intervention of Intracranial Aneurysms]; co-principal investigator, Grant No. R21 NS109575-01 [Optimizing Approaches to Endovascular Therapy of Acute Ischemic Stroke]). Dr Gray has served as a consultant for and received research support from Contego. Dr Heck has served as a consultant for Stryker. Dr Jovin has served as an advisor for, has been an investor in, or owns stock in Route92, Methinks, Galaxy, Viz.ai, Anaconda, and FreeOx Biotech; has served as a consultant for Cerenovus and Contego Medical; and has received grant support from Medtronic and Stryker Neurovascular. Dr Lyden has served as a consultant for Endologix, PQ Bypass, Boston Scientific, Medtronic, BD, Penumbra, and VIVA Physicians; has served as a board member for and received departmental research study support from Endologix, Gore, BD, Bolton, Abbott, Penumbra, Boston Scientific, Merit, and Contego Medical; and owns stock options in Centerline Biomedical. Dr Metzger has served as the principal investigator for the C-GUARDIANS, SAPPHIRE WW, and CANOPY CAS trials; and has served as the co-principal investigator for the CONFIDENCE CAS trial; has received symposium and proctor honoraria from Abbott Vascular; and has served on the advisory committee for Boston Scientific. Dr Rosenfield has served as a consultant or on the scientific advisory board for Althea Medical, Angiodynamics, Boston Scientific, Contego, InspireMD, Magneto, Mayo Clinic, Neptune Medical, Philips, Summa Therapeutics, Surmodics, Thrombolex, Terumo, and Truvic; has received institutional grant support from the National Institutes of Health, Abiomed, and Boston Scientific; owns equity interests in Accolade, Access Vascular, Aerami, Althea Medical, Contego, Cruzar Systems, Embolitech, Endospan, InspireMD, JanaCare, Magneto, Orchestra, PQ Bypass, Prosomnus, Shockwave, Summa Therapeutics, Thrombolex, Truvic, and Valcare; and has served as a board member for the National PERT Consortium. Dr Roubin has received from Cook Inc; and owns equity in Inspire MD. Dr Sachar has served as a consultant and advisory board member for Boston Scientific and Medtronic; has received institutional funds for research or clinical trials from Abbott Vascular, Boston Scientific, Bard Peripheral Vascular, Microvention, W.L. Gore and Associates, Medtronic, Terumo, and Veryan; and is a major shareholder of Contego Medical. Dr Siddiqui owns financial interest in, is an investor in, owns stock options, or has ownership in Adona Medical, Amnis Therapeutics, Bend IT Technologies, BlinkTBI, Buffalo Technology Partners, Cardinal Consultants, Cerebrotech Medical Systems, Cerevatech Medical, Cognition Medical, CVAID, Endostream Medical, Imperative Care, Instylla, International Medical Distribution Partners, Launch NY, NeuroRadial Technologies, Neurotechnology Investors, Neurovascular Diagnostics, PerFlow Medical, Q’Apel Medical, QAS.ai, Radical Catheter Technologies, Rebound Therapeutics (purchased 2019 by Integra Lifesciences), Rist Neurovascular (purchased 2020 by Medtronic), Sense Diagnostics, Serenity Medical, Silk Road Medical, Spinnaker Medical, StimMed, Synchron, Three Rivers Medical, Truvic Medical, Vastrax, VICIS, and Viseon; has served as a consultant or on the advisory board for Amnis Therapeutics, Apellis Pharmaceuticals, Boston Scientific, Canon Medical Systems USA, Cardinal Health 200, Cerebrotech Medical Systems, Cerenovus, Cerevatech Medical, Cordis, Corindus, Endostream Medical, Imperative Care, Integra, IRRAS AB, Medtronic, MicroVention, Minnetronix Neuro, Penumbra, Q’Apel Medical, Rapid Medical, Rebound Therapeutics, Serenity Medical, Silk Road Medical, StimMed, Stryker Neurovascular, Three Rivers Medical, VasSol, Viz.ai, and W.L. Gore and Associates; served as the national principal investigator for or on the steering committee of the Cerenovus EXCELLENT and ARISE II trial; the Medtronic SWIFT PRIME, VANTAGE, EMBOLISE and SWIFT DIRECT trials; the MicroVention FRED trial and CONFIDENCE study; the MUSC POSITIVE trial; the Penumbra 3D Separator trial, COMPASS trial, INVEST trial, MIVI neuroscience EVAQ trial; and the Rapid Medical SUCCESS trial. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The incidence of injection drug use-associated infective endocarditis has been increasing rapidly over the last decade. Patients with drug use-associated infective endocarditis present an increasingly common clinical challenge with poor long-term outcomes and high reinfection and readmission rates. Their care raises issues unique to this population, including antibiotic selection and administration, indications for and ethical issues surrounding surgical intervention, and importantly management of the underlying substance use disorder to minimize the risk of reinfection. Successful treatment of these patients requires a broad understanding of these concerns. A multidisciplinary, collaborative approach providing a holistic approach to treating both the acute infection along with effectively addressing substance use disorder is needed to improve short-term and longer-term outcomes., Competing Interests: Funding Support and Author Disclosures Dr Bearnot is supported by the National Institutes of Health/National Institute on Drug Abuse under grant K12DA043490. Dr Rosenfield has served as a consultant and/or Scientific Advisory Board member for Althea Medical, Angiodynamics, Boston Scientific, Contego, InspireMD, Magneto, Mayo Clinic, Neptune Medical, Phillips, Summa Therapeutics, Surmodics, Thrombolex, Terumo, and Truvic; holds equity in Accolade, Access Vascular, Aerami, Althea Medical, Contego, Cruzar Systems, Embolitech, Endospan, InspireMD, JanaCare, Magneto, Orchestra, PQ Bypass, Prosomnus, Shockwave, Summa Therapeutics, Thrombolex, Truvic, and Valcare; and is a Board Member for National PERT Consortium. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Minority patients such as Blacks, Hispanics, and Native Americans are disproportionately impacted by critical limb ischemia and amputation due to multiple factors such as socioeconomic status, type or lack of insurance, lack of access to health care, capacity and expertise of local hospitals, prevalence of diabetes, and unconscious bias. The Society of Interventional Radiology Foundation recognizes that it is imperative to close the disparity gaps and funded a Research Consensus Panel to prioritize a research agenda. The following research priorities were ultimately prioritized: (a) randomized controlled trial with peripheral arterial disease screening of at-risk patients with oversampling of high-risk racial groups, (b) prospective trial with the introduction of an intervention to alter a social determinant of health, and (c) a prospective trial with the implementation of an algorithm that requires criteria be met prior to an amputation. This article presents the proceedings and recommendations from the panel., (Copyright © 2022 SIR. Published by Elsevier Inc. All rights reserved.)

Background: Mortality rates for patients presenting with acute myocardial infarction (AMI) and cardiogenic shock (CS) remain high despite advances in revascularization strategies and mechanical circulatory support (MCS) devices., Objectives: This study sought to elucidate the association between comorbid lower extremity peripheral artery disease (PAD) and outcomes in CS and AMI., Methods: PAD status was defined in Medicare beneficiaries hospitalized with CS and AMI from October 1, 2015 to June 30, 2018. Primary outcomes ascertained through December 31, 2018 included in- and out-of-hospital mortality. Secondary outcomes included bleeding, amputation, stroke, and lower extremity revascularization. Multivariable regression models with adjustment for confounders were used to estimate risk. Subgroup analyses included patients treated with MCS and those who underwent coronary revascularization., Results: Among 71,690 patients, 5.9% (N = 4,259) had PAD. Mean age was 77.8 ± 7.9 years, 58.7% were male, and 84.3% were White. Cumulative in-hospital mortality was 47.2%, with greater risk among those with PAD (56.3% vs 46.6% without PAD; adjusted OR: 1.50; 95% CI: 1.40-1.59). PAD patients also had greater risk of in-hospital amputation (1.6% vs 0.2%; adjusted OR: 7.0; 95% CI: 5.26-9.37) and out-of-hospital mortality (67.9% vs 40.7%; adjusted HR: 1.78; 95% CI: 1.67-1.90). MCS was less frequently utilized in PAD patients (21.5% vs 38.6% without PAD; P < 0.001) and was associated with higher mortality, need for lower extremity revascularization, and amputation risk. Findings were consistent in patients who underwent coronary revascularization., Conclusions: Among patients presenting with AMI and CS, PAD was associated with worse limb outcomes and survival. In addition to lower MCS utilization rates, those with PAD who received MCS had increased mortality, lower extremity revascularization, and amputation rates., Competing Interests: Funding Support and Author Disclosures Dr Mihatov has been funded by National Institutes of Health (NIH) grant T32HL007208. Dr Kirtane has received funding for research grants, speaking engagements and/or consulting paid to his institutions from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, and ReCor Medical; and has received personal fees for travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr Parikh has received institutional research support from Abbott Vascular, TriReme Medical, SurModics, and Shockwave Medical; is an advisory board member for Abbott Vascular, Boston Scientific, Cardinal Health, Medtronic, Janssen, CSI, and Philips; and receives honoraria from Abiomed and Terumo. Dr Rosenfield has served as a consultant to or on the scientific advisory board for Access Vascular, Althea Medical, Angiodynamics, BMS-Pfizer, Boston Scientific, Contego, Janssen, InspireMD, Magneto, Mayo Clinic, Neptune Medical, Philips, Summa Therapeutics, Surmodics, Thrombolex, Terumo, and Truvic; has received institutional grants from the NIH, Philips, Intact Vascular, and Boston Scientific; has equity in Accolade, Access Vascular, Althea Medical, Contego, Cruzar Systems, Embolitech, Endospan, Eximo, InspireMG, JanaCare, Magneto, Micell, Neptune Medical, Orchestra, PQ Bypass, Prosomnus, Shockwave, Summa Therapeutics, Thrombolex, Truvic, and Valcare; and serves as a board member for the National PERT Consortium. Dr Yeh has served on scientific advisory boards, consulted for, and received research support from Abbott Vascular, AstraZeneca, Boston Scientific, and Medtronic; and receives funding from the National Heart, Lung, and Blood Institute grant R01HL136708 and the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology. Dr Secemsky has received consulting and/or speaking fees from Bard, Cook Medical, CSI, Medtronic, and Phillips; and receives research support from NIH/NHLBI K23HL150290, Food & Drug Administration, Harvard Medical School’s Shore Faculty Development Award, AstraZeneca, Bard, Boston Scientific, Cook Medical, CSI, Laminate Medical, Medtronic, and Philips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: Asymptomatic carotid stenosis is the most frequent indication for carotid endarterectomy (CEA) in the United States. Published trials and guidelines support CEA indications in selected patients with longer projected survival and when periprocedural complications are low. Transfemoral carotid artery stenting with embolic protection (CAS) is a newer treatment option. The objective of this study was to compare outcomes in asymptomatic, nonoctogenarian patients treated with CAS vs CEA., Methods: Patient-level data was analyzed from 2544 subjects with ≥70% asymptomatic carotid stenosis who were randomized to CAS or CEA in addition to standard medical therapy. One trial enrolled 1091 (548 CAS, 543 CEA) and another enrolled 1453 (1089 CAS, 364 CEA) asymptomatic patients less than 80 years old (upper age eligibility). Independent neurologic assessment and routine cardiac enzyme screening were performed. The prespecified, primary composite endpoint was any stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke within 4 years after randomization., Results: There was no significant difference in the primary endpoint between CAS and CEA (5.3% vs 5.1%; hazard ratio, 1.02; 95% confidence interval, 0.7-1.5; P = .91). Periprocedural rates for the components are (CAS vs CEA): any stroke (2.7% vs 1.5%; P = .07), myocardial infarction (0.6% vs 1.7%; P = .01), death (0.1% vs 0.2%; P = .62), and any stroke or death (2.7% vs 1.6%; P = .07). After this period, the rates of ipsilateral stroke were similar (2.3% vs 2.2%; P = .97)., Conclusions: In a pooled analysis of two large randomized trials of CAS and CEA in asymptomatic, nonoctogenarian patients, CAS achieves comparable short- and long-term results to CEA., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Intravascular lithotripsy (IVL) is a new technique for treatment of severely calcified lesions that uses acoustic shockwaves in a balloon-based system to induce fracture in calcific plaque, facilitating luminal gain and vessel expansion. In this review, we provide a concise summary of the available data and clinical experience of IVL in various peripheral vascular beds, including facilitating vascular access for large-bore devices. We discuss the physics and mode of action of IVL in modifying calcified plaques, include several illustrative examples of utility of IVL in peripheral interventions, and discuss the future directions for adoption of the technique in peripheral interventions., (Copyright © 2021. Published by Elsevier Inc.)

Background: The multicenter prospective CREST-2 Registry (C2R) provides recent experience in performing carotid artery stenting (CAS) for interventionists to ensure safe performance of CAS., Objective: To determine the periprocedural safety of CAS performed using a transradial approach relative to CAS performed using a transfemoral approach., Methods: Patients with ≥70% asymptomatic and ≥50% symptomatic carotid stenosis, ≤80 years of age and at standard or high risk for carotid endarterectomy (CEA) are eligible for the C2R. The primary endpoint was a composite of severe access-related complications. Comparisons were made using propensity-score matched logistic regression., Results: The mean age of the cohort was 67.6 ± 8.2 years and 1906 (35.1%) were female. Indications for CAS included 4063 (74.9%) for primary atherosclerosis. A total of 2868 (52.8%) cases underwent CAS for asymptomatic disease. Transradial access was used in 213 (3.9%) patients. The transradial cohort had lower use of general anesthesia (1.5% vs. 6.3%, p = 0.007) and higher use of distal embolic protection (96.7% vs. 89.4%, p = 0.0004). There were no significant differences between radial and femoral access groups in terms of a composite of major access-related complications (0% vs. 1.1%) or a composite of periprocedural stroke or death (3.3% vs. 2.4%; OR = 1.4 [confidence intervals 0.6, 3.1]; p = 0.42)., Conclusion: We found no significant differences in rates of major access-related complications or periprocedural stroke or death with CAS performed using transradial compared to transfemoral access. Our results support incorporation of the transradial approach to clinical trials comparing CAS to other revascularization techniques., (© 2021 Wiley Periodicals LLC.)

Acute pulmonary embolism (PE) is associated with significant morbidity and mortality. The management paradigm for acute PE has evolved in recent years with wider availability of advanced treatment modalities ranging from catheter-directed reperfusion therapies to mechanical circulatory support. This evolution has coincided with the development and implementation of institutional pulmonary embolism response teams (PERT) nationwide and internationally. Because most institutions are not equipped or staffed for advanced PE care, patients often require transfer to centers with more comprehensive resources, including PERT expertise. One of the unmet needs in current PE care is an organized approach to the process of interhospital transfer (IHT) of critically ill PE patients. In this review, we discuss medical optimization and support of patients before and during transfer, transfer checklists, defined roles of emergency medical services, and the roles and responsibilities of referring and receiving centers involved in the IHT of acute PE patients., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: The National Health Service demonstrated that regions of the United Kingdom with the highest number of patients enrolled in research studies had the lowest risk-adjusted mortality when patients were admitted to the hospital. Our goal was to investigate if this correlation was evident for patients with chronic limb threatening ischemia (CLI) treated in the United States (US). Accordingly, we examined correlations among sites participating in the Best Endovascular versus best Surgical Therapy in patients with Critical (BEST-CLI) trial, a multicenter, National Institute of Health-sponsored, international randomized controlled trial (RCT) comparing revascularization strategies in patients with CLI, and regional rates of major amputation from CLI., Methods: We measured regional participation in the BEST-CLI trial by evaluating trial participation and enrollment rosters. To determine regional rates of lower limb amputation, we queried the Medicare database (2007-2016) for patients with concurrent peripheral arterial disease (PAD) and diabetes, then assessed how many had lower extremity amputations. Correlation of regional amputation rates with distribution of BEST-CLI sites in four US geographical regions was calculated using Pearson's correlation coefficients. Simple regression equations were used to calculate the significance of these correlation coefficients., Results: Of 9,231,909 CLI patients, 342,406 underwent amputation in the Medicare dataset. Amputation rates per 1000 CLI patients differed by region (South 40.42, Midwest 40.12, West 34.81, Northeast 31.14). There were 116 US vascular centers, selected by volume and expertise that participated in BEST-CLI with the following distribution: South (n = 30, 26%), Midwest (n = 26, 22%), West (n = 29, 25%), and Northeast (n = 31, 27%). There was a negative correlation between the number of amputations per 1000 for Medicare CLI patients with diabetes and PAD and the number of BEST-CLI sites in the region which trended toward significance (Pearson R= -0.61, P = 0.39)., Conclusions: Amputation rate among Medicare CLI patients is inversely correlated with US BEST-CLI site distribution. Higher participation in clinical research, especially within large RCTs, may be a marker of optimal PAD management., Competing Interests: Conflicts of Interest: A.F.: Consultant for Sanifit. Matthew Menard: Scientific Advisory Board for Janssen; K.R.: multiple conflicts to be delivered under separate cover; No conflicts: J.S., M.E., P.G., M.S., M.V., M.V., T.H. report no conflicts., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

A 25-year-old woman with severe tricuspid valve endocarditis and septic pulmonary emboli required VA-ECMO for recurrent hypoxemia-induced cardiac arrest. We present the clinical challenges requiring ECMO circuit reconfiguration and a percutaneous approach for vegetation debulking. ( Level of Difficulty: Intermediate. )., Competing Interests: The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2021 The Authors.)

Background: Drug coated balloon (DCB) angioplasty significantly reduces reintervention rates in patients with symptomatic femoropopliteal peripheral artery disease (PAD). However, stand-alone DCB use in long, severely calcified lesions is frequently associated with vessel recoil and/or high-grade dissections necessitating provisional stent implantation., Objectives: Assess the safety and effectiveness of a vessel preparation strategy with directional atherectomy (DA) prior to DCB angioplasty in patients with symptomatic severely calcified femoropopliteal PAD., Methods: REALITY (NCT02850107) prospectively enrolled subjects at 13 multinational centers with 8-36 cm femoropopliteal stenoses or occlusions with bilateral vessel wall calcification treated with DA prior to DCB angioplasty. The primary effectiveness endpoint was 12-month primary patency, and the primary safety endpoint was freedom from major adverse events through 30 days. Independent angiographic and duplex core laboratories assessed outcomes and a Clinical Events Committee adjudicated events., Results: A total of 102 subjects were enrolled; one lesion was treated per subject. The mean lesion length was 17.9 ± 8.1 cm, 39.0% were chronic total occlusions (mean lesion length 22.6 ± 8.6 cm); 86.2% of lesions exhibited moderate to severe bilateral calcification. Provisional stents were implanted in 8.8% (9/102) of subjects. Twelve-month primary patency rate was 76.7% (66/86) and freedom from CD-TLR rate was 92.6% (87/94). No device or procedure related deaths and one index-limb major amputation were reported., Conclusions: Plaque excision with DA in patients with symptomatic severely calcified femoropopliteal arterial disease prior to DCB angioplasty is a safe and effective treatment strategy with a low provisional stent rate., (© 2021 Wiley Periodicals LLC.)

Background: Although acute intracranial hemorrhage (ICH) is a rare complication of catheter-directed thrombolysis (CDT), it remains a major concern associated with the use of CDT. The incidence and clinical predictors of developing ICH in the setting of CDT are not known., Methods: The National Inpatient Sample database was used to identify all patients with proximal lower extremity or caval deep vein thrombosis (DVT) from January 2005 to December 2013 in the United States. Multivariate logistic regression was performed to identify the clinical predictors of ICH between patients with DVT who had received anticoagulation therapy alone and those who had been treated with CDT plus anticoagulation therapy., Results: Of 138,049 patients with proximal lower extremity or caval DVT, 7119 (5.2%) had received anticoagulation therapy and CDT. Of the patients treated with anticoagulation alone, ICH had occurred in 0.2% compared with 0.7% for those treated with CDT (P < .01). The independent predictors of ICH in the CDT cohort were a history of stroke (odds ratio [OR], 19.4; 95% confidence interval [CI], 8.8-42.8; P < .01), chronic kidney disease (OR, 2.2; 95% CI, 1.1-4.7; P = .03), age >74 years (OR, 2.2; 95% CI, 1.2-4.3; P = .02), male sex (OR, 1.8; 95% CI, 1.01-3.3; P = .048). Of those patients treated with anticoagulation alone, the risk factors for the development of ICH were a history of stroke, hospital teaching status, and age >74 years., Conclusions: The results from the present nationwide observational study showed that of patients with DVT treated with CDT, the independent predictors for developing ICH were a history of stroke, chronic kidney disease, male sex, and age >74 years., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Ascertainment bias is a well-recognized source of bias in research, but few studies have systematically analyzed sources of ascertainment bias in randomized trials in which blinding is not possible and endpoint assessment is not protocolized. In the current study, we sought to evaluate differences in the clinical practice patterns of trial investigators with respect to bias in the ascertainment of pre-revascularization patient risk and the incidence of secondary endpoints post-revascularization. We conducted a cross-sectional survey of active investigators ( n = 936) from the Best Endovascular Versus Best Surgical Therapy for Patients with Critical Limb Ischemia (BEST-CLI) trial. The total survey response rate was 19.6% (183/936). Vascular surgeons were more likely than nonsurgical interventionalists to order tests for cardiac complications after both surgical bypass ( p < 0.001) and endovascular revascularization ( p = 0.038). Post-procedure, investigators were more likely to order additional testing for cardiac complications in open surgery versus endovascular cases (7% vs 16% never, 41% vs 65% rarely, 43% vs 17% sometimes, 9% vs 2% always, respectively; p < 0.0001). Significant variation in practice patterns exist in the pre- and post-procedure assessment of cardiac risk and events for patients with CLI undergoing revascularization. Variation in the ascertainment of risk and outcomes according to the type of revascularization procedure and physician specialty should be considered when interpreting the results of clinical studies, such as the BEST-CLI trial. ClinicalTrials.gov Identifier: NCT02060630 .

Background: The presence of a contralateral carotid occlusion (CCO) is an established high-risk feature for patients undergoing carotid endarterectomy (CEA) and is traditionally an indication for carotid artery stenting (CAS). Recent observational data have called into question whether CCO remains a high-risk feature for CEA., Objectives: The purpose of this study was to determine the clinical impact of CCO among patients undergoing CEA and CAS in a contemporary nationwide registry., Methods: All patients undergoing CEA or CAS from 2007 to 2019 in the NCDR CARE (National Cardiovascular Data Registry Carotid Artery Revascularization and Endarterectomy) and PVI (Peripheral Vascular Intervention) registries were included. The primary exposure was the presence of CCO. The outcome was a composite of in-hospital death, stroke, and myocardial infarction. Multivariable logistic regression and inverse-probability of treatment weighting were used to compare outcomes., Results: Among 58,423 patients who underwent carotid revascularization, 4,624 (7.9%) had a CCO. Of those, 68.9% (n = 3,185) underwent CAS and 31.1% (n = 1,439) underwent CEA. The average age of patients with CCO was 69.5 ± 9.7 years, 32.6% were women, 92.8% were Caucasian, 51.7% had a prior transient ischemic attack or stroke, and 45.4% presented with symptomatic disease. Over the study period, there was a 41.7% decrease in the prevalence of CCO among patients who underwent carotid revascularization (p < 0.001), but CAS remained the primary revascularization strategy. Unadjusted composite outcome rates were lower in patients with CCO after CAS (2.1%) than CEA (3.6%). Following adjustment, CCO was associated with a 71% increase in the odds of an adverse outcome after CEA (95% confidence interval: 1.27 to 2.30; p < 0.001) compared with no increase after CAS (adjusted odds ratio: 0.94; 95% confidence interval: 0.72 to 1.22; p = 0.64)., Conclusions: CCO remains an important predictor of increased risk among patients undergoing CEA, but not CAS., Competing Interests: Funding Support and Author Disclosures This work was funded by the American College of Cardiology’s National Cardiovascular Data Registry. Dr. Rosenfield has served as a consultant to or on the scientific advisory board for Abbott Vascular, Access Closure, BTG, Cordis-Cardinal Health, Eximo Medical, Volcano-Philips, Surmodics, Shockwave, Cruzar, Capture Vascular, Endospan, Janssen, Magneto, MD Insider, Micell, Silk Road, Valcare, Thrombolex, and the University of Maryland; has received grants and contracts from the National Institutes of Health and Inari; has equity in Access Closure, AngioDynamics, Contego, Endospan, Embolitech, Eximo Medical, JanaCare, PQBypass, Primacea, MD Insider, Silk Road, Cruzar Systems, Capture Vascular, Micell, and Valcare; and is a board member for VIVA Physicians and the National PERT Consortium. Dr. Jaff is a part-time employee of Boston Scientific. Dr. Jones has served as principal investigator for a research study for Agency for Healthcare Research and Quality, AstraZeneca, American Heart Association, Bristol Myers Squibb, Doris Duke Charitable Foundation, Medtronic, and the Patient-Centered Outcomes Research Institute; and has served as an advisory board member for Bayer, Bristol Myers Squibb, and Janssen Pharmaceuticals. Dr. Secemsky is supported by a National Institutes of Health/National Heart, Lung, and Blood Institutes K23HL150290 award; has served as a consultant and/or on the scientific advisory board of Abbott Vascular, Becton Dickinson, Boston Scientific, Cook, CSI, Janssen, Medtronic, and Philips; and has received research grants from AstraZeneca, BD, Boston Scientific, Cook, CSI, Medtronic, and Philips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The authors analyzed data from the NCDR (National Cardiovascular Data Registry) PVI Registry and defined acute kidney injury (AKI) as increased creatinine of ≥0.3 mg/dl or 50%, or a new requirement for dialysis after PVI., Background: AKI is an important and potentially modifiable complication of peripheral vascular intervention (PVI). The incidence, predictors, and outcomes of AKI after PVI are incompletely characterized., Methods: A hierarchical logistic regression risk model using pre-procedural characteristics associated with AKI was developed, followed by bootstrap validation. The model was validated with data submitted after model creation. An integer scoring system was developed to predict AKI after PVI., Results: Among 10,006 procedures, the average age of patients was 69 years, 58% were male, and 52% had diabetes. AKI occurred in 737 (7.4%) and was associated with increased in-hospital mortality (7.1% vs. 0.7%). Reduced glomerular filtration rate, hypertension, diabetes, prior heart failure, critical or acute limb ischemia, and pre-procedural hemoglobin were independently associated with AKI. The model to predict AKI showed good discrimination (optimism corrected c-statistic = 0.68) and calibration (corrected slope = 0.97, intercept of -0.07). The integer point system could be incorporated into a useful clinical tool because it discriminates risk for AKI with scores ≤4 and ≥12 corresponding to the lower and upper 20% of risk, respectively., Conclusions: AKI is not rare after PVI and is associated with in-hospital mortality. The NCDR PVI AKI risk model, including the integer scoring system, may prospectively estimate AKI risk and aid in deployment of strategies designed to reduce risk of AKI after PVI., Competing Interests: Funding Support and Author Disclosures This study was funded by a grant from the National Cardiovascular Data Registry. Dr. Latif has received honoraria from Abbott Vascular, Inc. Dr. Shammas has received research and educational grants from Boston Scientific, Bard, VentureMed Group, Phillips, and Intact Vascular; and has served on speaker bureaus for Janssen, Novartis, Boehringer Ingelheim, and Zoll Medical. Dr. Spertus has been the principal investigator of a contract from the American College of Cardiology Foundation to analyze the NCDR data; and has an equity interest in Health Outcomes Sciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The Registry Assessment of Peripheral Devices (RAPID) convened a multidisciplinary group of stakeholders including clinicians, academicians, regulators and industry representatives to conduct an in-depth review of limitations associated with the data available to assess the paclitaxel mortality signal. Available studies were evaluated to identify strengths and limitations in the study design and data quality, which were translated to lessons learned to help guide the design, execution, and analyses of future studies. We suggest numerous actionable responses, such as the development and use of harmonized data points and outcomes in a consensus lean case report form. We advocate for reduction in missing data and efficient means for accrual of larger sample sizes in Peripheral arterial disease studies or use of supplemental datasets. Efforts to share lessons learned and working collaboratively to address such issues may improve future data in this device area and ultimately benefit patients. Condensed Abstract: Data sources evaluating paclitaxel-coated devices were evaluated to identify strengths and limitations in the study design and data quality, which were translated to lessons learned to help guide the design, execution, and analyses of future studies. We suggest numerous actionable responses, which we believe may improve future data in this device area and ultimately benefit patients., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: The Bashir Endovascular Catheter (BEC) is a novel pharmaco-mechanical device designed to enhance thrombolysis by increasing the exposure of thrombus to endogenous and exogenous thrombolytics. The aim of this prospective, multicenter, single-arm study was to evaluate the feasibility and initial safety of the BEC in patients with acute intermediate-risk pulmonary embolism (PE)., Methods: Patients with symptomatic PE and right ventricular to left ventricular diameter ratio ≥0.9 as documented by computer tomography angiography were eligible for enrollment. The primary safety end points were device related death or adverse events, and major bleeding within 72 hours after BEC directed therapy., Results: Nine patients were enrolled across 4 US sites. The total dose of r-tPA (recombinant tissue-type plasminogen activator) was 14 mgs in bilateral PE and 12 mgs in unilateral PE over 8 hours delivered via the expanded BEC. At 30-day follow-up, there were no deaths or device-related adverse events. At 48 hours post-BEC therapy, the right ventricular to left ventricular diameter ratio decreased from 1.52±0.26 to 0.97±0.06 ( P =0.0009 [95% CI, 0.33-0.82]; 37.0% reduction). Thrombus burden as measured by the Modified Miller Index decreased from 25.4±5.3 to 16.0±4.0 ( P =0.0005; [95% CI, 5.5-13.4]; 37.1% reduction)., Conclusions: In this early feasibility study of the BEC for intermediate-risk PE, there were no deaths or device-related adverse events and a significant reduction in right ventricular to left ventricular diameter ratio and thrombus burden. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03927508.

Superior vena cava (SVC) syndrome comprises a constellation of clinical signs and symptoms caused by obstruction of blood flow through the SVC. The management of patients with life-threatening SVC syndrome is evolving from radiation therapy to endovascular therapy as the first-line treatment. There is a paucity of data and societal guidelines with regard to the management of SVC syndrome. This paper aims to update the practicing interventionalists with the contemporary and the evolving therapeutic approach to SVC syndrome. In addition, the review will focus on endovascular techniques, including catheter-directed thrombolysis, angioplasty, and stenting, and their associated complications., Competing Interests: Author Disclosures Dr. Rosenfield has served as a consultant for Abbott, Access Vascular, Accolade, Capture Vascular, Endospan, Magneto, Micell, Shockwave, Silk Road, Surmodics, Thrombolex, and Valcare; owns equity interest in Access Vascular, Contego, Embolitech, Eximo, MD Insider, Janacare, PQ Bypass, and Primacea; and has received research or fellowship support from National Institutes of Health. Dr. Bashir owns equity interest in Thrombolex Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The coexistence of coronavirus disease 2019 (COVID-19) and pulmonary embolism (PE), two life-threatening illnesses, in the same patient presents a unique challenge. Guidelines have delineated how best to diagnose and manage patients with PE. However, the unique aspects of COVID-19 confound both the diagnosis and treatment of PE, and therefore require modification of established algorithms. Important considerations include adjustment of diagnostic modalities, incorporation of the prothrombotic contribution of COVID-19, management of two critical cardiorespiratory illnesses in the same patient, and protecting patients and health-care workers while providing optimal care. The benefits of a team-based approach for decision-making and coordination of care, such as that offered by pulmonary embolism response teams (PERTs), have become more evident in this crisis. The importance of careful follow-up care also is underscored for patients with these two diseases with long-term effects. This position paper from the PERT Consortium specifically addresses issues related to the diagnosis and management of PE in patients with COVID-19., (Copyright © 2020 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Paclitaxel drug-coated balloons (DCBs) reduce restenosis, but their overall safety has recently raised concerns. This study hypothesized that DCBs could lessen inflammation and reduce plaque progression. Using 25 rabbits with cholesterol feeding- and balloon injury-induced lesions, DCB-percutaneous transluminal angioplasty (PTA), plain PTA, or sham-PTA (balloon insertion without inflation) was investigated using serial intravascular near-infrared fluorescence-optical coherence tomography and serial intravascular ultrasound. In these experiments, DCB-PTA reduced inflammation and plaque burden in nonobstructive lesions compared with PTA or sham-PTA. These findings indicated the potential for DCBs to serve safely as regional anti-atherosclerosis therapy., (© 2020 The Authors.)

Experiments in male rodents demonstrate that sensitivity to the organizational effects of steroid hormones decreases across the pubertal window, with earlier androgen exposure leading to greater masculinization of the brain and behavior. Similarly, some research suggests the timing of peripubertal exposure to sex steroids influences aspects of human psychology, including visuospatial cognition. However, prior studies have been limited by small samples and/or imprecise measures of pubertal timing. We conducted 4 studies to clarify whether the timing of peripubertal hormone exposure predicts performance on male-typed tests of spatial cognition in adulthood. In Studies 1 (n = 1095) and 2 (n = 173), we investigated associations between recalled pubertal age and spatial cognition in typically developing men, controlling for current testosterone levels in Study 2. In Study 3 (n = 51), we examined the relationship between spatial performance and the age at which peripubertal hormone replacement therapy was initiated in a sample of men with Isolated GnRH Deficiency. Across Studies 1-3, effect size estimates for the relationship between spatial performance and pubertal timing ranged from. -0.04 and -0.27, and spatial performance was unrelated to salivary testosterone in Study 2. In Study 4, we conducted two meta-analyses of Studies 1-3 and four previously published studies. The first meta-analysis was conducted on correlations between spatial performance and measures of the absolute age of pubertal timing, and the second replaced those correlations with correlations between spatial performance and measures of relative pubertal timing where available. Point estimates for correlations between pubertal timing and spatial cognition were -0.15 and -0.12 (both p < 0.001) in the first and second meta-analyses, respectively. These associations were robust to the exclusion of any individual study. Our results suggest that, for some aspects of neural development, sensitivity to gonadal hormones declines across puberty, with earlier pubertal hormone exposure predicting greater sex-typicality in psychological phenotypes in adulthood. These results shed light on the processes of behavioral and brain organization and have implications for the treatment of IGD and other conditions wherein pubertal timing is pharmacologically manipulated., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) is a pair of randomized trials assessing the relative efficacy of carotid revascularization in the setting of intensive medical management (IMM) in patients with asymptomatic high-grade atherosclerotic stenosis. One of the trials assesses IMM with or without carotid artery stenting (CAS). Given the low risk of stroke in nonrevascularized patients receiving IMM, it is essential that there be low periprocedural risk of stroke for CAS if it is to show incremental benefit. Thus, credentialing of interventionists to ensure excellence is vital. This analysis describes the protocol-driven approach to credentialing of CAS interventionists for CREST-2 and its outcomes., Methods: To be eligible to perform stenting in CREST-2, interventionists needed to be credentialed on the basis of a detailed Interventional Management Committee (IMC) review of data from their last 25 consecutive cases during the past 24 months along with self-reported lifetime experience case numbers. When necessary, additional prospective cases performed in a companion registry were requested after webinar training. Here we review the IMC experience from the first formal meeting on March 21, 2014 through October 14, 2017., Results: The IMC had 102 meetings, and 8311 cases submitted by 334 interventionists were evaluated. Most were either cardiologists or vascular surgeons, although no single specialty made up the majority of applicants. The median total experience was 130 cases (interquartile range [IQR], 75-266; range, 25-2500). Only 9% (30/334) of interventionists were approved at initial review; approval increased to 46% (153/334) after submission of new cases with added training and re-review. The median self-reported lifetime case experience for those approved was 211.5 (IQR, 100-350), and the median number of cases submitted for review was 30 (IQR, 27-35). The number of CAS procedures performed per month (case rate) was the only factor associated with approval during the initial cycle of review (P < .00001)., Conclusions: Identification of interventionists who were deemed sufficiently skilled for CREST-2 has required substantial oversight and a controlled system to judge current skill level that controls for specialty-based practice variability, procedural experience, and periprocedural outcomes. High-volume interventionists, particularly those with more recent experience, were more likely to be approved to participate in CREST-2. Primary approval was not affected by operator specialty., (Copyright © 2019. Published by Elsevier Inc.)

Background: The FlowTriever Pulmonary Embolectomy Clinical Study (FLARE) was a multicenter, single-arm trial that demonstrated effectiveness of the FlowTriever percutaneous pulmonary embolectomy system in reducing right ventricular/left ventricular (RV/LV) diameter ratio in patients with acute intermediate-risk pulmonary embolism (PE). Patients diagnosed in emergency departments (EDs) with acute PE may have a different presentation from those diagnosed in an in-hospital setting., Objectives: The goal of this sub-study was to evaluate the safety and effectiveness of mechanical embolectomy in ED patients with acute intermediate-risk PE., Methods: ED patients with acute PE and RV/LV ratio ≥ 0.9 enrolled in the FLARE study were core laboratory analyzed. The primary efficacy endpoint was the change in RV/LV ratio from baseline to 48 h post procedure. The change in RV/LV ratio of patients with nonelevated cardiac troponin (cTn) and zero simplified PE Severity Index (sPESI) score (normal cTn-sPESI: intermediate-low risk) was also examined. Major adverse events (MAEs) included major bleeding, device-related death or clinical deterioration, and vascular or cardiac injury., Results: Seventy-six ED patients were included. Thirty-nine had a sPESI score of ≥ 1 and 32 had elevated cTn. The median preprocedure RV/LV ratio for all ED patients was 1.50 (0.88-2.52), with a change by -0.37 postprocedure (p < 0.001.) Three patients experienced MAEs. Seventeen patients (22.4%) presented with normal cTn-sPESI and had an RV/LV ratio reduced by 0.27 (p < 0.001) after embolectomy., Conclusion: ED patients with intermediate-risk PE had significant improvement in their RV/LV ratio and low complication rates when treated with mechanical embolectomy, irrespective of their baseline cTn-sPESI risk score., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Although randomized controlled trials (RCTs) provide the most reliable form of scientific evidence, they are challenging to complete because of a variety of enrollment obstacles. We evaluated obstacles in a large RCT by comparing survey results at high-performing sites (HPS) and low-performing sites (LPS)., Methods: The Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial is a prospective, pragmatic, multicenter, and multispecialty RCT that will compare clinical outcomes, quality of life, and cost in patients with CLI randomized to surgical bypass or endovascular therapy. BEST-CLI aims to enroll 2100 patients at 160 sites in North America, Europe, and New Zealand. We surveyed the 30 HPS and 30 LPS to assess perceptions of enrollment obstacles. HPS were defined by enrollment of 0.5 subjects or more per month or more than 8 total subjects enrolled. LPS were defined by enrollment of 0.1 subjects per month or only 1 subject total. Responses were compared by site performance status., Results: There were 22 of 30 (73%) HPS and 14 of 30 (47%) LPS that answered the survey (P = 0.06), including 17 investigators and 31 coordinators. The mean total enrollment and rate of enrollment at HPS and LPS were 12.5 subjects at 1.5 subjects/month and 1.0 subject at 0.1 subjects/month, respectively. The most common barrier to enrollment at HPS was difficulty convincing patients and their families to participate (36%), whereas at LPS both difficulty convincing patients and difficulty motivating investigators to enroll (29% each) were most frequently cited. At HPS, the most common obstacle to consenting patients for the trial was patient/family having strong preference toward revascularization strategy (32%) and at LPS it was patient/family not wanting to have treatment chosen at random (36%). At 55% of HPS and 43% of LPS, the trial team was reported as extremely collaborative (P = 0.73), whereas 68% of HPS and 64% of LPS reported having identified a trial champion on their team (P = 1). The most restrictive perceived enrollment criterion at HPS was prior index limb stenting with significant restenosis (32%), whereas at LPS it was excessive risk for surgical bypass (43%). Materials to aid enrollment were used equally at HPS and LPS: patient brochures at 59% HPS and 64% LPS (P = 1); investigator talking points at 45% of HPS and 36% of LPS (P = 0.73)., Conclusions: Patient perceptions and investigator biases are significant challenges to enrollment in large RCTs. In the BEST-CLI trial, difficulty convincing patients and families to allow treatment randomization and difficulty in motivating investigators were major enrollment obstacles., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: The CREST-2 Registry (C2R) was approved by National Institute of Neurological Disorders and Stroke-National Institutes of Health in September 2014 with Centers for Medicare & Medicaid Services, U.S. Food and Drug Administration, and industry collaboration to enroll patients undergoing CAS. The registry credentials interventionists and promotes optimal patient selection, procedural-technique, and outcomes., Objectives: This study reports periprocedural outcomes in a cohort of carotid artery stenting (CAS) performed for asymptomatic and symptomatic carotid stenosis., Methods: Asymptomatic patients with ≥70% and symptomatic patients with ≥50% carotid stenosis, ≤80 years of age, and at standard or high risk for carotid endarterectomy are eligible for enrollment. Interventionists are credentialed by a multispecialty committee that reviews experience, lesion selection, technique, and outcomes. The primary endpoint was a composite of stroke and death (S/D) in the 30-day periprocedural period. Myocardial infarction and access-site complications were assessed as secondary outcomes., Results: As of December 2018, 187 interventionists from 98 sites in the United States performed 2,219 CAS procedures in 2,141 patients with primary atherosclerosis (78 were bilateral). The mean age of the cohort was 68 years, 65% were male, and 92% were white; 1,180 (55%) were for asymptomatic disease, and 961 (45%) were for symptomatic disease. All U.S. Food and Drug Administration-approved stents and embolic protection devices were represented. The 30-day rate of S/D was 1.4% for asymptomatic, 2.8% for symptomatic, and 2.0% for all patients., Conclusions: C2R is the first national registry for CAS cosponsored by federal and industry partners. CAS was performed by experienced operators using appropriate patient selection and optimal technique. In that setting, a broad group of interventionists achieved very low periprocedural S/D rates for asymptomatic and symptomatic patients., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to assess safety outcomes of femoropopliteal drug-coated balloon (DCB) angioplasty using patient-level data from the Lutonix clinical program., Background: A recent systematic review and meta-analysis of heterogenous trials and summary-level data identified increased long-term mortality in patients treated with paclitaxel-coated balloons and stents., Methods: We evaluated DCB angioplasty (n = 1,093) and uncoated balloon angioplasty (percutaneous transluminal angioplasty [PTA]) (n = 250) outcomes in LEVANT 1 (The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis), LEVANT 2 (Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries), and the LEVANT Japan Clinical Trial. Hazard ratios (HRs) were calculated with Cox proportional hazards modeling., Results: There were no significant differences in mortality rates between DCB angioplasty and PTA. The 5-year HR was 1.01 (95% confidence interval [CI]: 0.68 to 1.52) in the aggregated LEVANT trials. The 2-year HR after DCB angioplasty was 0.99 (95% CI: 0.25 to 3.95) in LEVANT 1, 1.40 (95% CI: 0.62 to 3.14) in LEVANT 2, and 0.32 (95% CI: 0.05 to 1.92) in the LEVANT Japan Clinical Trial. The 5-year HR was 1.60 (95% CI: 0.94 to 2.72) in LEVANT 2. Adverse events and causes of death were balanced, without clustering between DCB angioplasty and PTA. Patients who underwent paclitaxel or nonpaclitaxel reinterventions had higher survival rates than those who did not undergo reinterventions. Baseline covariates predicting mortality included, among others, age (HR: 1.03 per year; p < 0.0001), prior treatment of target lesion (HR: 1.67; p = 0.022), arrhythmia (HR: 1.65; p = 0.031), and diabetes (HR: 1.18; p = 0.047), without differences between the 2 arms. No dose-response relationship was identified when adjusted for key predictors of mortality., Conclusions: Analyses of patient-level data identified no mortality differences between DCB angioplasty and PTA. Furthermore, the lack of dose-response relationships or clustering of causes of death argues against a causal relationship between paclitaxel and mortality. (LEVANT 1, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis [LEVANT 1], NCT00930813; Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries [LEVANT 2], NCT01412541; LEVANT 2 Continued Access Registry, NCT01628159; LEVANT Japan Clinical Trial, NCT01816412)., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Lower extremity peripheral artery disease (PAD) and cerebrovascular disease (CeVD) are prevalent conditions in the United States, and both are associated with significant morbidity (eg, stroke, myocardial infarction, and limb loss) and increased mortality. With a growth in invasive procedures for PAD and CeVD, this demands a more clear responsibility and introduces an opportunity to study how patients are treated and evaluate associated outcomes. The American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Peripheral Vascular Intervention (PVI) Registry is a prospective, independent collection of data elements from individual patients at participating centers, and it is a natural extension of the already robust NCDR infrastructure. As of September 20, 2018, data have been collected on 45,316 lower extremity PVIs, 12,417 carotid artery stenting procedures, and 11,027 carotid endarterectomy procedures at 208 centers in the United States. The purpose of the present report is to describe the patient and procedural characteristics of the overall cohort and the methods used to design and implement the registry. In collecting these data, ACC and ACC PVI Registry have the opportunity to play a pivotal role in scientific evidence generation, medical device surveillance, and creation of best practices for PVI and carotid artery revascularization., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Peripheral vascular disease affects millions of individuals worldwide, and results in significant morbidity and mortality. The complex nature of the disease, the presence of multiple comorbidities, and the existence of a wide variety of therapeutic options suggests that a multidisciplinary approach to treatment has the potential to improve care of these patients. The success of the heart team for complex coronary artery and structural heart disease could serve as a model for the efficient and effective management of patients with peripheral vascular disease. In this paper, the authors propose a multidisciplinary vascular team approach for the treatment of critical limb ischemia, pulmonary embolism, acute ischemic stroke, and acute aortic syndromes. The successful implementation of such vascular teams has the potential to significantly enhance quality of care, improve clinical outcomes, and reduce costs. Prospective evaluation is warranted to determine how to best integrate this approach into routine clinical care., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the FlowTriever System (Inari Medical, Irvine, California) in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE)., Background: Catheter-directed thrombolysis has been shown to improve right ventricular (RV) function in patients with PE. However, catheter-directed thrombolysis increases bleeding risk and many patients with PE have relative and absolute contraindications to thrombolysis., Methods: Patients with symptomatic, computed tomography-documented PE and RV/left ventricular (LV) ratios ≥0.9 were eligible for enrollment. The primary effectiveness endpoint was core laboratory-assessed change in RV/LV ratio. The primary safety endpoint comprised device-related death, major bleeding, treatment-related clinical deterioration, pulmonary vascular injury, or cardiac injury within 48 h of thrombectomy., Results: From April 2016 to October 2017, 106 patients were treated with the FlowTriever System at 18 U.S. sites. Two patients (1.9%) received adjunctive thrombolytics and were analyzed separately. Mean procedural time was 94 min; mean intensive care unit stay was 1.5 days. Forty-three patients (41.3%) did not require any intensive care unit stay. At 48 h post-procedure, average RV/LV ratio reduction was 0.38 (25.1%; p < 0.0001). Four patients (3.8%) experienced 6 major adverse events, with 1 patient (1.0%) experiencing major bleeding. One patient (1.0%) died, of undiagnosed breast cancer, through 30-day follow-up., Conclusions: Percutaneous mechanical thrombectomy with the FlowTriever System appears safe and effective in patients with acute intermediate-risk PE, with significant improvement in RV/LV ratio and minimal major bleeding. Potential advantages include immediate thrombus removal, absence of thrombolytic complications, and reduced need for post-procedural critical care., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The Best Endovascular vs Best Surgical Therapy for Patients with Critical Limb Ischemia (BEST-CLI) trial compares open surgery and endovascular therapy for the treatment of critical limb ischemia (CLI). This report describes the types and proportion of investigators participating in BEST-CLI and determines how these compare with those specialists treating peripheral artery disease (PAD) outside of the trial., Methods: To be credentialed to enroll in BEST-CLI, investigators must be approved by the Surgical and Interventional Management Committee to have sufficient experience and skill in the management of patients with CLI. Investigators must attest to having completed at least 12 below-knee interventions in the last 2 years on CLI patients for endovascular approval and 10 lower extremity below-knee bypass procedures in the last 2 years for open surgical treatment. Investigators who met these criteria but were within their first year of practice were conditionally approved to do procedures under the oversight of a fully approved investigator. The type and proportion of specialists credentialed in BEST-CLI were compared with those treating PAD on a national basis by auditing 10% of Medicare claims for PAD., Results: As of September 2017, a total of 865 physicians were credentialed to enroll in the BEST-CLI trial. Of these, 596 (69%) are vascular surgeons, 128 (15%) are interventional cardiologists, 123 (14%) are interventional radiologists, 7 (1%) are vascular medicine specialists, and 11 (1%) are other. Of the 596 vascular surgeons enrolling in the trial, 113 (19%) are credentialed for open surgery only, 409 (69%) are credentialed for both open surgery and endovascular therapy, and 3 (1%) are credentialed for only endovascular therapy. The remaining 71 participating vascular surgeons were conditionally approved. Of the 136 centers enrolling patients, multispecialty involvement is present in 98 (72%). In 38 (28%), vascular surgery alone is the service enrolling CLI patients. Endovascular treatment by specialty in BEST-CLI vs national Medicare claims is as follows: vascular surgery, 55% vs 51%; interventional cardiology, 17% vs 13%; interventional radiology, 16% vs 25%; and other, 2% vs 10%., Conclusions: BEST-CLI contains a diverse group of specialists enrolling and treating patients with CLI. Whereas a majority of the participating practitioners are vascular surgeons who do both open and endovascular procedures, a broad variety of specialists are represented in BEST-CLI in a pattern that represents national treatment patterns outside of the BEST-CLI trial. These treatment patterns will help ensure that findings from BEST-CLI are applicable to the real-world practice of treatments for PAD., (Copyright © 2018. Published by Elsevier Inc.)

Importance: In a recent meta-analysis of randomized clinical trials, femoropopliteal artery revascularization with paclitaxel drug-coated devices was associated with increased long-term all-cause mortality compared with non-drug-coated devices. However, to our knowledge, these findings have not been replicated in other data sources and may be subject to confounding from missing data associated with patient withdrawal and loss to follow-up., Objective: To evaluate differences in all-cause mortality between patients who were treated with drug-coated devices vs non-drug-coated devices for femoropopliteal artery revascularization., Design, Setting, and Participants: This nationwide, multicenter retrospective cohort study included 16 560 Centers for Medicare and Medicaid Services beneficiaries who were admitted for femoropopliteal artery revascularization from January 1, 2016, to December 31, 2016. All-cause mortality was analyzed through September 30, 2017., Exposures: Drug-coated devices (drug-eluting stent [DES] or drug-coated balloon [DCB]) compared with non-drug-coated devices (bare metal stent or uncoated percutaneous transluminal angioplasty balloon)., Main Outcomes and Measures: The primary outcome was all-cause mortality analyzed through the end of follow-up., Results: Among 16 560 patients treated at 1883 hospitals, the mean (SD) age was 72.9 (11) years, 7734 (46.7%) were men, 12 232 (73.9%) were white, 8222 (49.7%) currently or had previously used tobacco, 9817 (59.3%) had diabetes, and 8450 (51.0%) had critical limb ischemia (CLI). Drug-coated devices were used in 5989 participants (36.2%). The median follow-up was 389 days (interquartile range, 277-508 days). Among all patients, treatment with drug-coated devices was associated with a lower cumulative incidence of all-cause mortality compared with treatment with non-drug-coated devices through 600 days postprocedure (32.5% vs 34.3%, respectively; log-rank P = .007). Similar survival trends were observed when treatment was stratified by using a DCB alone or DES with or without DCB. After multivariable adjustment, drug-coated devices were not associated with a difference in all-cause mortality compared with non-drug-coated devices (hazard ratio [HR], 0.97; 95% CI, 0.91-1.04; P = .43). These findings were consistent among those with CLI (HR, 0.93; 95% CI, 0.85-1.01; P = .09) or without CLI (HR, 0.94; 95% CI, 0.85-1.03; P = .20), and for those treated with DCB alone (HR, 0.94; 95% CI, 0.86-1.03; P = .17) or DES with or without DCB (HR, 0.97; 95% CI, 0.89-1.06; P = .48)., Conclusions and Relevance: In this large nationwide analysis of Centers for Medicare and Medicaid Services beneficiaries, there was no evidence of increased all-cause mortality following femoropopliteal artery revascularization with drug-coated devices compared with non-drug-coated devices.

There is significant variability and equipoise in the management of critical limb ischemia (CLI). The Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial, funded by the National Heart, Lung, and Blood Institute, is a prospective, open label, multicenter, multispecialty randomized controlled trial designed to compare treatment efficacy, functional outcomes, cost-effectiveness, and quality of life for 2100 patients suffering from CLI. BEST-CLI is enrolling those patients who are determined to be candidates for open surgical or endovascular revascularization and is designed to be comprehensive, pragmatic, and balanced. Enrollment is occurring at >130 sites across the world, and BEST-CLI is nearing the finish line. Although the trial has encountered a number of obstacles, they are being successfully navigated. This trial promises to establish an evidence-based standard of care in the management of this population of vulnerable patients., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Intermediate-risk pulmonary embolism (PE) has variable outcomes. Current risk stratification models lack the positive predictive value to identify patients at highest risk of PE-related mortality. We identified intermediate-risk PE patients who underwent catheter-based interventions and right heart catheterization (RHC) and identified those with low cardiac index (CI < 2.2 L/min/m 2 ). We utilized regression models to identify echocardiographic predictors of low CI and Kaplan Meier curve to evaluate PE-related mortality when stratified by the echocardiographic predictor. Of 174 intermediate-risk PE patients, 41 underwent RHC. Within this cohort, 46.3% had low CI. Univariable linear regression identified right ventricular outflow tract velocity time integral (RVOT VTI), right/left ventricular ratio, S prime, inferior vena cava diameter, and pulmonary artery systolic pressure as potential predictors of low CI. Multivariable linear regression identified RVOT VTI as significant predictor of low CI (β coefficient 0.124, 95% confidence interval [CI]: 0.01-0.24, P = .034). Right ventricular outflow tract velocity time integral <9.5 cm was associated with increased PE-related mortality, P = .002. A substantial proportion of intermediate-risk PE patients referred for catheter-based interventions had low CI despite normotension. Right ventricular outflow tract velocity time integral was a significant predictor of low CI. Low RVOT VTI was associated with increased PE-related mortality.