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.

A Comprehensive Review of Risk Factors and Thrombophilia Evaluation in Venous Thromboembolism.

Venous thromboembolism (VTE), which encompasses deep vein thrombosis (DVT) and pulmonary embolism (PE), is a significant cause of morbidity and mortality worldwide. There are many factors, both acquired and inherited, known to increase the risk of VTE. Most of these result in increased risk via several common mechanisms including circulatory stasis, endothelial damage, or increased hypercoagulability. Overall, a risk factor can be identified in the majority of patients with VTE; however, not all risk factors carry the same predictive value. It is important for clinicians to understand the potency of each individual risk factor when managing patients who have a VTE or are at risk of developing VTE. With this, many providers consider performing a thrombophilia evaluation to further define a patient's risk. However, guidance on who to test and when to test is controversial and not always clear. This comprehensive review attempts to address these aspects/concerns by providing an overview of the multifaceted risk factors associated with VTE as well as examining the role of performing a thrombophilia evaluation, including the indications and timing of performing such an evaluation.

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.

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.

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.

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.

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.

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.

Genomic insights into rapid speciation within the world's largest tree genus Syzygium.

Species radiations, despite immense phenotypic variation, can be difficult to resolve phylogenetically when genetic change poorly matches the rapidity of diversification. Genomic potential furnished by palaeopolyploidy, and relative roles for adaptation, random drift and hybridisation in the apportionment of genetic variation, remain poorly understood factors. Here, we study these aspects in a model radiation, Syzygium, the most species-rich tree genus worldwide. Genomes of 182 distinct species and 58 unidentified taxa are compared against a chromosome-level reference genome of the sea apple, Syzygium grande. We show that while Syzygium shares an ancient genome doubling event with other Myrtales, little evidence exists for recent polyploidy events. Phylogenomics confirms that Syzygium originated in Australia-New Guinea and diversified in multiple migrations, eastward to the Pacific and westward to India and Africa, in bursts of speciation visible as poorly resolved branches on phylogenies. Furthermore, some sublineages demonstrate genomic clines that recapitulate cladogenetic events, suggesting that stepwise geographic speciation, a neutral process, has been important in Syzygium diversification.

Association of Fibromuscular Dysplasia and Pulsatile Tinnitus: A Report of the US Registry for Fibromuscular Dysplasia.

Background Fibromuscular dysplasia (FMD) is a nonatherosclerotic arterial disease that has a variable presentation including pulsatile tinnitus (PT). The frequency and characteristics of PT in FMD are not well understood. The objective of this study was to evaluate the frequency of PT in FMD and compare characteristics between patients with and without PT. Methods and Results Data were queried from the US Registry for FMD from 2009 to 2020. The primary outcomes were frequency of PT among the FMD population and prevalence of baseline characteristics, signs/symptoms, and vascular bed involvement in patients with and without PT. Of 2613 patients with FMD who were included in the analysis, 972 (37.2%) reported PT. Univariable analysis and multivariable logistic regression were performed to explore factors associated with PT. Compared with those without PT, patients with PT were more likely to have involvement of the extracranial carotid artery (90.0% versus 78.6%; odds ratio, 1.49; P=0.005) and to have higher prevalence of other neurovascular signs/symptoms including headache (82.5% versus 62.7%; odds ratio, 1.82; P<0.001), dizziness (44.9% versus 22.9%; odds ratio, 2.01; P<0.001), and cervical bruit (37.5% versus 15.8%; odds ratio, 2.73; P<0.001) compared with those without PT. Conclusions PT is common among patients with FMD. Patients with FMD who present with PT have higher rates of neurovascular signs/symptoms, cervical bruit, and involvement of the extracranial carotid arteries. The coexistence of the 2 conditions should be recognized, and providers who evaluate patients with PT should be aware of FMD as a potential cause.

Navigating between the science and art of acute limb ischemia treatment.

The diagnosis and treatment of acute limb ischemia (ALI) has long been a fierce adversary that has evolved over the last several decades with scientific advancements in endovascular therapy. History and physical examination remain the mainstay of diagnosis enhanced by detailed imaging to guide therapy. Many endovascular tools are available for prompt restoration of flow that compliment traditional surgical options. These devices incorporate the mechanical removal of thrombus and the chemical dissolution of thrombus . Medical decision-making for ALI patients must take into account the patient characteristics, anatomic variables, mechanism of ischemia, degree of ischemia, and operator skill to employ the right strategy for the right patient. This moving target challenges scientific study, making the therapeutic bedside decision making an artform. We present an overview of the field, supportive data, and a treatment algorithm that hopefully captures this delicate balance.

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 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.