Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization.

BACKGROUND: In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL). METHODS: Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression. RESULTS: A total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, -0.14 [95% CI, -0.25 to -0.02]; P=0.02), SF-12 MCS (difference, -1.03 [95% CI, -1.89 to -0.18]; P=0.02), SF-6D R2 (difference, -0.01 [95% CI, -0.02 to -0.001]; P=0.03), numeric rating scale pain at present (difference, 0.26 [95% CI, 0.03 to 0.49]; P=0.03), usual level during previous week (difference, 0.26 [95% CI, 0.04 to 0.48]; P=0.02), and worst level during previous week (difference, 0.29 [95% CI, 0.02 to 0.56]; P=0.04). There was no difference between treatment arms on the basis of EQ-5D (difference, -0.01 [95% CI, -0.03 to 0.004]; P=0.12) or SF-12 PCS (difference, -0.41 [95% CI, -1.2 to 0.37]; P=0.31). In cohort 2, HRQoL also significantly improved from baseline to the end of follow-up for both groups based on all measures, but there were no differences between Bypass and Endo on any measure. CONCLUSIONS: Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.

Reclaiming the Bedside of the Vascular Patient.

There are many challenges to meet the needs of our patients in this health-care environment. How we approach each patient, with a caring attitude, a real physical examination, and diligent reasoning prior to treatment is foundational. Survey data reveal that we fall short in many patient encounters. This review provides a rationale for reclaiming the bedside, identifying ways to refocus our attention on the patient while dealing with a problem to be solved.

Refining Vascular Care Through Science Without Losing the Art.

The science of medicine involves the incorporation of data from evidence-based medicine (collecting, analyzing, conducting clinical trials), medical knowledge (learned patterns of health and disease), diagnostic testing (objective evidence), treatment protocols (guidelines based on scientific evidence and/or expert consensus), and pharmacology (prescribing safely and effectively). The art of medicine involves clinical judgment (learn to interpret clinical signs, symptoms, and histories often relying on intuition and gut feelings), bedside manner (understanding patient needs), customization of care (artistic touch to meet each person's unique circumstances including values, preferences, and social determinants of health), complex decision-making (decision-making based on experience or expertise when confronted with limited or conflicting data), and managing uncertainty (making decisions keeping "doors open" when faced with limited objective confirmation). The delivery of healthcare is not "either science or art" but rather "both science and art" proposition. So, how do we wrestle with this potential paradox?

The Importance of Team Alignment and Retention in Vascular Center Development: A Clinician's Perspective.

The healthcare landscape is in a state of constant evolution, presenting both challenges and opportunities. Recent trends, including the departure or retirement of medical professionals, the rise in travel and per diem positions, and the expansive growth of healthcare networks, have resulted in a palpable divide within the field. This divide often manifests as a shift from prioritizing patient care and staff well-being toward financial security and operational efficiency and productivity. Amid these ongoing changes, vascular centers possess the potential for a positive distinction that extends beyond their specialization to encompass their approaches to patient care and team dynamics. This article presents a 3-phase strategy for vascular clinicians and centers to consider as they seek to attract and retain top-tier staff, provide exceptional patient care, and attain sustainable growth and financial success.

Outcomes of Endovascular Treatment for Critical Limb Threatening Ischemia.

BACKGROUND: Critical limb threatening ischemia (CLTI), particularly in patients with ischemic ulceration has been associated with significant morbidity and mortality. Typically, endovascular therapy has been first-line therapy for our patients, but this strategy has come into question based upon the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Threatening Ischemia (BEST-CLI) trial data. METHODS AND RESULTS: For comparative purposes, we evaluated outcomes from 150 CLTI patients with ischemic ulceration treated with endovascular-first therapy. The mean age was 72 years in this predominate male, Caucasian, ambulatory group. The major co-morbidities were smoking history in 49% and diabetes mellitus in 67%.` Anatomic scoring, using Society for Vascular Surgery criteria, revealed only 35.6% had favorable anatomy (Global Limb Anatomical Staging System stage of 0,1) for long-term patency compared to 64.4% of limbs with unfavorable anatomy for long-term patency (Global Limb Anatomical Staging System stage 2,3). Stents were used in 47% of cases. Reintervention occurred in 36% over 24 months follow-up. At 12 and 24 months, the Kaplan-Meier projections for survival was 0.80 (0.73, 0.87) and 0.69 (0.59, 0.79); amputation was 0.69 (0.61, 0.77) and 0.59 (0.46, 0.71); amputation-free survival (AFS) was 0.56 (0.48, 0.65) and 0.38 (0.27, 0.50), respectively. Amputation was more common in those with reinterventions (P = 0.033). Mortality was predicted with ankle brachial index ≤0.40 or ≥1.30 (P = 0.0019) and the presence of infection (P = 0.0047). AFS was predicted by the presence of any infection (P = 0.0001). CONCLUSIONS: Despite technically successful endovascular treatment, patients who present with CLTI maintain a high-risk for limb loss and mortality. Amputation prevention must vigilantly address infection risk. These data correlate with outcomes from BEST-CLI trial enhancing applicability to patient-centered care.

Long-Term Follow-up of Subjects With Iliac Occlusive Disease Treated With the Viabahn VBX Balloon-Expandable Endoprosthesis.

INTRODUCTION: This physician-initiated study provides 5-year (i.e., long-term) treatment durability data from 3 top recruitment sites that participated in the prospective, multicenter, nonrandomized, single-arm VBX FLEX clinical study (ClinicalTrials.gov identifier: NCT02080871). It evaluates the long-term treatment durability of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX Stent-Graft) in the treatment of subjects with de novo or restenotic aortoiliac lesions. MATERIALS AND METHODS: A total of 59 subjects with 94 treated lesions were enrolled at the 3 participating sites from the original 140 intent-to-treat subjects in the VBX FLEX study. The primary durability endpoint was long-term primary patency. Secondary long-term outcomes included freedom from target lesion revascularization (TLR), freedom from target vessel revascularization (TVR), as well as resting ankle-brachial index (ABI), Rutherford category, EuroQol 5 Dimensions, and Walking Impairment status. RESULTS: Fifty-nine subjects participated and twenty-eight (47.5%) were available through the end of the study at 5-year follow-up (the median follow-up time was 6.6 years due to complications resulting from COVID-19 precautions). At 3 and 5 years, the Kaplan-Meier estimates for freedom from all-cause mortality were 94.5% and 81.7%, respectively. The Kaplan-Meier estimates for primary patency at 3 and 5 years were 94.0% and 89.5% (by lesion) and 91.7% and 84.4% (by subject). Primary assisted patency at 3 and 5 years were 93.3% and 93.3%. Kaplan-Meier estimate for freedom from TLR at 5 years was 89.1%. The majority of subjects were asymptomatic (Rutherford category 0) at 3 years (29/59; 72%), and at 5-year follow-up (18/28; 64%). The 5-year mean resting ankle-brachial index was 0.95±0.18, an improvement of 0.15±0.26 from the baseline (p<0.001). Quality of life measures also showed sustained improvement through long-term follow-up. CONCLUSION: The 5-year long-term follow-up data underscore the robustness and durability of the Viabahn Balloon-Expandable Endoprosthesis for treating aortoiliac occlusive disease. CLINICAL IMPACT: Durable improvement after endovascular treatment of iliac occlusive disease is clinically important because many of these patients are claudicants with significant life expectancy. This study is the first to evaluate the long-term outcomes in patients with iliac occlusive disease treated with the Viabahn VBX balloon-expandable endopirostheses. The study reports excellent long-term patency outcomes with prolonged clinical benefit. These durable results are likely to be an important consideration for clinicians undertaking iliac artery revascularization procedures.

Cilostazol as a Treatment for COVID Toes: A Case Report.

During the Coronavirus Disease 2019 (COVID-19) pandemic, skin lesions resembling those seen in pernio (chilblains) have been observed in patients with COVID-19 infection. The term "COVID toes" has been used when there is toe involvement. We describe the case of a fully vaccinated, 56-year-old woman with no prior diagnosis of COVID-19 who developed pernio-like lesions many months after being vaccinated. Her skin lesions resolved after treatment with cilostazol, suggesting that this medication may be a viable treatment for pernio in the setting of COVID-19 infection.

Pounce Thrombectomy System to Treat Acute and Chronic Peripheral Arterial Occlusions.

Peripheral arterial occlusions are composed of variable amounts of thrombus. Endovascular techniques should initially address the variably aged thrombus prior to treating plaque (percutaneous transluminal angioplasty (PTA) ± stenting). This should ideally be accomplished in a single procedural session. Forty-four consecutive patients treated with the Pounce thrombectomy system (PTS) as captured in a retrospective database, who presented with acute (n = 18), subacute (n = 7), or chronic (n = 19) lower extremity ischemia, were treated and followed for a mean of 7 months. The peripheral occlusions were considered thrombus-dominant by the feel and ease of wire traversal. They were treated with PTS along with complimentary PTA/stenting when appropriate. The mean number of passes with PTS was 4.0 ± 2.7. Sixty-five percent (29/44) were successfully revascularized in a single setting with only 2 requiring concomitant thrombolysis for incomplete thrombus removal from the PTS target artery. An additional 15 patients (34%) had thrombolysis for tibial thrombus that was not attempted with PTS. PTA ± stenting after PTS occurred in 57% of limbs. Technical success was 83% and procedural success was 95%. Reintervention rate throughout follow-up was 22.7%. Major amputation occurred in 4.5%. Complications were limited to minor groin hematomas (n = 3). Outcomes were equally effective in patients with pre-existing stents or denovo arterial occlusions as evidenced with ankle brachial index improvement from 0.48 pre-to 0.93 postintervention and 0.95 at latest follow-up (P < 0.001). PTS coupled with PTA/stenting is expeditiously safe and effective in patients with thrombus-associated lower limb occlusion.

Comparison of Complications and Cost for Transfemoral Versus Transcarotid Stenting of Carotid Artery Stenosis.

BACKGROUND: Options for endovascular treatment of carotid artery disease have been developed to compliment with carotid endarterectomy, transfemoral carotid artery stenting (TFCAS) and a hybrid approach with transcarotid artery revascularization (TCAR). We sought to capture endpoints outside of stroke, myocardial infarction (MI), and death involved with each procedure at our institution as well as evaluate cost. METHODS: Carotid stent procedures performed from 2014 to 2020 at our institution underwent comparative analysis based upon access site and type of stent procedure performed, TFCAS versus TCAR. Procedural details and outcomes were captured prospectively and included in the National Cardiovascular Data Peripheral Vascular Intervention Registry (NCDR-PVI). Further retrospective review was performed to evaluate endpoints beyond stroke, MI, and death. Total in-hospital cost, including administrative, capital and utilities (fixed cost), and labor and supplies (variable cost) were also evaluated. RESULTS: One hundred thirty-seven patients were reviewed. Seventy-seven were treated with TFCAS and 60 with TCAR. The mean age was 74 years, predominantly male (68%) and Caucasian (90%). Patients undergoing TFCAS were more likely to be symptomatic compared to those receiving TCAR (81.8% vs. 50.0%, P = <0.001). There were no statistically significant differences in event rates, including mortality, recurrent cerebrovascular accident / transient ischemic attack, or bleeding. Complications not captured in the NCDR-PVI database were more frequent in the TCAR group (21.7% vs. 5.2%, P = 0.004) and included pneumothorax (n = 2), neck hematoma (n = 8), and common carotid artery stenosis or injury (n = 3). Rates of complications in the TFCAS group (n = 4) were lower and limited to groin hematoma (n = 2), central retinal artery occlusion causing vision loss and a case of postoperative dysphagia. Geographic miss of initial stent placement was identified in 15.0% of TCAR patients and 2.6% (P = 0.008) of TFCAS patients. Restenosis rates on duplex ultrasound were similar between the two groups (14.6% of patients) and were not associated with symptoms. The mean follow-up interval was similar for both groups of 31.8 months for TCAR and 30.7 months for TFCAS (P = 0.797). There was a statistically significant difference in total cost with TCAR being more expensive ($22,315 vs. $11,001) driven by direct costs that included devices, imaging, and extended length of stay in the TCAR group (P < 0.001). There was no significant difference between stroke free survival (91.1% vs. 88.6%, P = 0.69) and mortality (78.1% vs. 85.2%, P = 0.677) at 3 years follow-up between TCAR and TFCAS, respectively. CONCLUSIONS: Both TFCAS and TCAR provide similar 3-year stroke and mortality risk/benefit and are distinctly different procedures. Both should be evaluated independently with analysis of variables beyond stroke, death, and MI. TFCAS is more cost-effective than TCAR in this single institution study.

Establishing Diagnostic Reference Levels for CT Through a Provincial Medical Informatics Metadata Repository in Ontario.

PURPOSE: To determine whether computed tomography radiation dose data could be captured electronically across hospitals to derive regional diagnostic reference levels for quality improvement. METHODS: Data on consecutive computed tomography examinations from 8 hospitals were collected automatically in a central database (Repository) from April 2017 to September 2017. The most frequently performed examinations were used to determine the standard protocols for each hospital. Diagnostic reference levels across hospitals were derived using statistical distribution for 2 radiation dose metrics. These values were compared between hospitals, within and between hospitals by scanner and against national Health Canada achievable doses and diagnostic reference levels. RESULTS: Three master protocol groups, Head, Abdomen-Pelvis, and Chest-Abdomen-Pelvis, accounted for 43% of all valid studies (N = 40 277). For the Repository, 11 of 12 mean values and 75th percentile diagnostic reference levels were below the Health Canada mean and 75th percentile values, and one was the same as the Health Canada value. Mean radiation dose by protocol varied by as much as 97% between hospitals. There was no consistent pattern in the difference between mean doses between large and small hospitals. CONCLUSION: This electronic data acquisition process could be used to continually update achievable doses for frequently used computed tomography examinations in Ontario and eliminate the need for nationwide manual surveys. Results compared across institutions will allow hospitals to maintain achievable doses and lower patient exposure.

Canadian Association of Radiologists White Paper on De-identification of Medical Imaging: Part 2, Practical Considerations.

The application of big data, radiomics, machine learning, and artificial intelligence (AI) algorithms in radiology requires access to large data sets containing personal health information. Because machine learning projects often require collaboration between different sites or data transfer to a third party, precautions are required to safeguard patient privacy. Safety measures are required to prevent inadvertent access to and transfer of identifiable information. The Canadian Association of Radiologists (CAR) is the national voice of radiology committed to promoting the highest standards in patient-centered imaging, lifelong learning, and research. The CAR has created an AI Ethical and Legal standing committee with the mandate to guide the medical imaging community in terms of best practices in data management, access to health care data, de-identification, and accountability practices. Part 2 of this article will inform CAR members on the practical aspects of medical imaging de-identification, strengths and limitations of de-identification approaches, list of de-identification software and tools available, and perspectives on future directions.

Canadian Association of Radiologists White Paper on De-Identification of Medical Imaging: Part 1, General Principles.

The application of big data, radiomics, machine learning, and artificial intelligence (AI) algorithms in radiology requires access to large data sets containing personal health information. Because machine learning projects often require collaboration between different sites or data transfer to a third party, precautions are required to safeguard patient privacy. Safety measures are required to prevent inadvertent access to and transfer of identifiable information. The Canadian Association of Radiologists (CAR) is the national voice of radiology committed to promoting the highest standards in patient-centered imaging, lifelong learning, and research. The CAR has created an AI Ethical and Legal standing committee with the mandate to guide the medical imaging community in terms of best practices in data management, access to health care data, de-identification, and accountability practices. Part 1 of this article will inform CAR members on principles of de-identification, pseudonymization, encryption, direct and indirect identifiers, k-anonymization, risks of reidentification, implementations, data set release models, and validation of AI algorithms, with a view to developing appropriate standards to safeguard patient information effectively.

Three-Year Follow-up of Patients With Iliac Occlusive Disease Treated With the Viabahn Balloon- Expandable Endoprosthesis.

PURPOSE: To assess the midterm safety and effectiveness of the Gore Viabahn Balloon-Expandable Endoprosthesis (VBX Stent-Graft) in the treatment of patients with de novo or restenotic aortoiliac lesions. MATERIALS AND METHODS: The prospective, multicenter, nonrandomized, single-arm VBX FLEX clinical study (ClinicalTrials.gov identifier: NCT02080871) evaluated 134 patients (mean age 66±9.5 years; 79 men) up to 3 years after treatment with the VBX Stent-Graft. A total of 213 lesions were treated with 234 stent-grafts. The primary safety endpoint was a composite of major adverse events (MAEs), which were evaluated through 30 days and 9 months. Secondary outcomes collected through 3 years included freedom from target lesion revascularization (TLR), target vessel revascularization (TVR), clinically-driven TLR (CD-TLR), and CD-TVR as well as Rutherford category, resting ankle-brachial index (ABI), and functional status. A univariate analysis determined any correlation between baseline variables and TLR. RESULTS: The observed composite percentage of MAEs was 2.3%, well below the 17% performance goal (p<0.001). Of the 134 patients in the per protocol analysis, 107 (80%) completed the study. The 1-year Kaplan-Meier estimate of primary patency was 94.5% and primary assisted patency was 99.0%. The estimate of freedom from TLR per-lesion/vessel was 97.6% at 9 months and 91.2% at 3 years. The 9-month estimate of freedom from CD-TLR was 98.6% and the 3-year estimate was 98.1%. The 3-year mean resting ABI was 0.93±0.19, an improvement of 0.17±0.26 from baseline (p<0.001). At 3 years, 82 patients (92.1%) improved ≥1 Rutherford category from baseline, and 77 patients (86.5%) maintained or improved upon their baseline functional status. CONCLUSION: The VBX Stent-Graft is a robust and durable treatment option for aortoiliac occlusive disease as evidenced by the sustained 3-year safety and effectiveness outcomes.

Expanding opportunities to understand quality and outcomes of peripheral vascular interventions: The ACC NCDR PVI Registry.

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.

Comparison of specialties participating in the BEST-CLI trial to specialists treating peripheral arterial disease nationally.

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.

Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia.

GUIDELINE SUMMARY: Chronic limb-threatening ischemia (CLTI) is associated with mortality, amputation, and impaired quality of life. These Global Vascular Guidelines (GVG) are focused on definition, evaluation, and management of CLTI with the goals of improving evidence-based care and highlighting critical research needs. The term CLTI is preferred over critical limb ischemia, as the latter implies threshold values of impaired perfusion rather than a continuum. CLTI is a clinical syndrome defined by the presence of peripheral artery disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration. Venous, traumatic, embolic, and nonatherosclerotic etiologies are excluded. All patients with suspected CLTI should be referred urgently to a vascular specialist. Accurately staging the severity of limb threat is fundamental, and the Society for Vascular Surgery Threatened Limb Classification system, based on grading of Wounds, Ischemia, and foot Infection (WIfI) is endorsed. Objective hemodynamic testing, including toe pressures as the preferred measure, is required to assess CLTI. Evidence-based revascularization (EBR) hinges on three independent axes: Patient risk, Limb severity, and ANatomic complexity (PLAN). Average-risk and high-risk patients are defined by estimated procedural and 2-year all-cause mortality. The GVG proposes a new Global Anatomic Staging System (GLASS), which involves defining a preferred target artery path (TAP) and then estimating limb-based patency (LBP), resulting in three stages of complexity for intervention. The optimal revascularization strategy is also influenced by the availability of autogenous vein for open bypass surgery. Recommendations for EBR are based on best available data, pending level 1 evidence from ongoing trials. Vein bypass may be preferred for average-risk patients with advanced limb threat and high complexity disease, while those with less complex anatomy, intermediate severity limb threat, or high patient risk may be favored for endovascular intervention. All patients with CLTI should be afforded best medical therapy including the use of antithrombotic, lipid-lowering, antihypertensive, and glycemic control agents, as well as counseling on smoking cessation, diet, exercise, and preventive foot care. Following EBR, long-term limb surveillance is advised. The effectiveness of nonrevascularization therapies (eg, spinal stimulation, pneumatic compression, prostanoids, and hyperbaric oxygen) has not been established. Regenerative medicine approaches (eg, cell, gene therapies) for CLTI should be restricted to rigorously conducted randomizsed clinical trials. The GVG promotes standardization of study designs and end points for clinical trials in CLTI. The importance of multidisciplinary teams and centers of excellence for amputation prevention is stressed as a key health system initiative.

First International Consensus on the diagnosis and management of fibromuscular dysplasia.

This article is a comprehensive document on the diagnosis and management of fibromuscular dysplasia (FMD), which was commissioned by the working group 'Hypertension and the Kidney' of the European Society of Hypertension (ESH) and the Society for Vascular Medicine (SVM). This document updates previous consensus documents/scientific statements on FMD published in 2014 with full harmonization of the position of European and US experts. In addition to practical consensus-based clinical recommendations, including a consensus protocol for catheter-based angiography and percutaneous angioplasty for renal FMD, the document also includes the first analysis of the European/International FMD Registry and provides updated data from the US Registry for FMD. Finally, it provides insights on ongoing research programs and proposes future research directions for understanding this multifaceted arterial disease.

Subclinical involvement of common carotid arteries in patients with fibromuscular dysplasia - a case-control study.

Background: Fibromuscular dysplasia (FMD) primarily involves medium-sized arteries, though the entire spectrum of vascular involvement is not fully understood. We hypothesized that larger arteries may also be affected, albeit sub-clinically. Patients and methods: We measured the cross-sectional diameter of the thoracic aorta, abdominal aorta, common iliac arteries (CIA) and common carotid arteries (CCA) in FMD subjects and compared them to matched controls. We retrospectively analyzed records of FMD subjects (n = 74) and of age- and sex- matched controls (n = 74) that underwent computed tomography of the neck, chest or abdomen. Cross-sectional diameters of the thoracic and abdominal aorta, CIA and CCA were measured in a standardized manner by two trained physicians. Results: The FMD group had a significantly greater diameter of the CIA and CCA bilaterally. The measurements (mm) in FMD and control groups were as follows: Right CIA: 10.85 + 1.75 vs. 10.23 + 1.36, p = 0.04, left CIA: 11.01 + 1.93 vs. 10.15 + 1.38, p = 0.007, right CCA: 7.70 + 0.81 vs. 6.80 + 1.10, p < 0.001 and left CCA: 7.70 + 1.10 vs. 6.80 + 1.0, p < 0.001). There was no difference in the diameter between the two groups in the ascending aorta, descending and the abdominal aorta. After adjusting for baseline differences, common carotid arteries (but not common iliac) were significantly larger in FMD group compared with controls. Conclusions: There is sub-clinical involvement of the common carotid arteries in patients with FMD and this manifests as a greater diameter of these arteries compared to age and sex matched controls.