Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease.

BACKGROUND: Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown. METHODS: In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death. RESULTS: The primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan-Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group. CONCLUSIONS: Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point. (Funded by Abbott; LIFE-BTK ClinicalTrials.gov number, NCT04227899.).

Three-Year Outcomes of the Abre Venous Self-Expanding Stent System in Patients with Symptomatic Iliofemoral Venous Outflow Obstruction.

PURPOSE: To report 36-month outcomes and subgroup analysis of the ABRE study evaluating the safety and effectiveness of the Abre venous self-expanding stent system for the treatment of symptomatic iliofemoral venous outflow obstruction disease. METHODS: The ABRE study was a prospective, multicenter, nonrandomized study that enrolled and implanted Abre venous stents in 200 participants (mean age 51.5 years [SD ± 15.9], 66.5% women) with symptomatic iliofemoral venous outflow obstruction at 24 global sites. Outcomes assessed through 36 months included patency, major adverse events, stent migration, stent fracture, and quality-of-life changes. Adverse events and imaging studies were adjudicated by independent clinical events committee and core laboratories, respectively. RESULTS: Primary, primary-assisted, and secondary patency through 36 months by Kaplan-Meier estimates were 81.6%, 84.8%, and 86.3%, respectively. The cumulative incidence of major adverse events through 36 months was 10.2%, mainly driven by 12 thrombosis events. Subgroup analyses demonstrated a primary patency of 76.5% in the acute deep vein thrombosis group, 70.4% in the postthrombotic syndrome group, and 97.1% in the nonthrombotic iliac vein lesion group through 36 months. The overall mean lesion length was 112.4 mm (SD ± 66.1). There were no stent fractures or migrations in this study. Quality of life and venous functional assessments demonstrated significant improvements from baseline to 36 months across all patient subsets. CONCLUSIONS: Results from the ABRE study demonstrated sustained patency with a good safety profile after implantation of a dedicated venous stent in patients with symptomatic iliofemoral venous outflow obstruction disease.

Recapturing the Team Approach to Vascular Care.

BACKGROUND: The care of the vascular patient remains decentralized rather than coordinated. METHODS: We reviewed the current state of practice and published competency and care documents created by vascular professional societies. RESULTS: Vascular professional societies routinely and repeatedly endorse both a team approach and the competency of specialists from disparate training backgrounds. The care of the vascular patient does not always reflect these public endorsements. CONCLUSIONS: Centering the vascular patient as the mode of organization of care should improve care processes, expertise brought to bear, and outcomes.

Incidence and predictors of acute limb ischemia in acute myocardial infarction complicated by cardiogenic shock.

OBJECTIVE: To describe the incidence and predictors of acute limb ischemia (ALI) in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS). METHODS: Patients with index hospitalizations for AMI complicated by cardiogenic shock from 2016 to 2019 in the US National Readmission Database were identified. We evaluated the incidence of ALI and its associated mortality, length of stay, and cost of hospitalization. We used multivariable logistic regression to determine independent predictors of ALI in this population. RESULTS: A total of 84,615 patients had AMI complicated by cardiogenic shock and 1302 (1.54%) developed ALI. The rates of ALI increased from 1.29% in 2016 to 1.66% in 2019 (P ≤ .002). The use of microaxial mechanical circulatory support increased from 2.25% in 2016 to 13.36% in 2019 (P = .0001). The major predictors of ALI included peripheral arterial disease (odds ratio [OR], 7.34; 95% confidence interval [CI], 6.12-8.81), venoarterial extracorporeal membrane oxygenation (OR, 4.40; 95% CI, 3.19-6.07), and microaxial mechanical circulatory support (OR, 3.12; 95% CI, 2.74-3.55). ALI in patients with cardiogenic shock was associated higher mortality (39.20% vs 33.53%; P ≤ .0001). CONCLUSIONS: This nationwide observational study shows that ALI is an important complication of AMI with cardiogenic shock. This complication is associated with higher mortality. In addition to peripheral artery disease, the use of mechanical circulatory devices was associated with significantly higher rates of ALI.

An estimate of the economic burden of venous leg ulcers associated with deep venous disease.

INTRODUCTION: Venous leg ulcers (VLU) embody the most severe stage of the broad spectrum of chronic venous disease. Approximately 40% of patients with VLU present with the underlying deep venous disease (DVD). Although the data are scarce, these deep venous disease-related VLU (DRV) are thought to have higher recurrence rates and a substantial economic burden. The objective of this study was to assess the economic burden of DRV across Australia, France, Germany, Italy, Spain, the UK, and the USA. METHODS: A comprehensive literature review was undertaken to identify publications documenting the incidence and prevalence of VLU and DRV, medical resource utilization, and associated costs of DRV. Findings from this literature review were used to estimate the economic burden of illness, including direct medical costs over a 12-month interval following initial presentation of a newly formed DRV. RESULTS: Total annual incidence of new or recurrent DRV in Australia, France, Germany, Italy, Spain, UK, and the US are estimated at 122,000, 263,000, 345,000, 253,000, 85,000, 230,000, and 643,000 events, respectively, in 2019. Incidence ranges from 0.73 to 3.12 per 1000 persons per year. The estimated annual direct medical costs for patients managed conservatively in these geographies total ~ $10.73 billion (USD) or $5527 per person per year. CONCLUSION: The availability of published data on the costs of VLU care varies widely across countries considered in this analysis. Although country-specific VLU practice patterns vary, there is a uniform pattern of high-cost care.

Endovascular mechanical thrombectomy versus thrombolysis in patients with iliofemoral deep vein thrombosis - a systematic review and meta-analysis.

Background: This study sought to compare effectiveness and safety of percutaneous mechanical thrombectomy (PMT) and thrombolysis alone (THR) in patients with acute or subacute iliofemoral deep vein thrombosis (IfDVT). Patients and methods: Observational and randomized trials, published between January 2001 to February 2019 were identified by searching MEDLINE. Studies on deep venous thrombosis (DVT) treated with either THR or PMT adjunctive to conventional anticoagulation and compressive intervention were included. Meta-analysis of proportions was conducted to assess effectiveness outcomes of successful lysis and primary patency, post-thrombotic syndrome (PTS), valvular reflux, recurrent DVT, as well as safety outcomes of major bleeding, hematuria, and pulmonary embolism. Results: Of 77 identified records, 17 studies including 1417 patients were eligible. Pooled proportion of successful lysis was similar between groups (THR: 95 % [I2 = 68.4 %], PMT 96 %, [I2 = 0 %]; Qbet [Cochran's Q between groups] 0.3, p = 0.61). However, pooled proportion of 6-month primary patency was lower after THR than after PMT (68 % [I2 = 15.6 %] versus 94 %; Qbet 26.4, p < 0.001). Considerable heterogeneity within groups did not allow for between-group comparison of PTS and recurrent DVT. Major bleeding was more frequent after THR than after PMT (6.0 % [I2 = 0 %] versus 1.0 % [I2 = 0 %]; Qbet 12.3, p < 0.001). Incidence of hematuria was lower after THR as compared to PMT (2 % [I2 = 56 %] versus 91.3 % [I2 = 91.7 %]; Qbet 714, p < 0.001). Incidences of valvular reflux and pulmonary embolism were similar across groups (THR: 61 % versus PMT: 53 %; Qbet 0.7, p = 0.39 and THR: 2 % versus PMT: 1 %; Qbet 1.1, p = 0.30, respectively). Conclusions: In patients with iliofemoral DVT, percutaneous mechanical thrombectomy was associated with a higher cumulative 6-month primary patency and a lower incidence of major bleeding compared to thrombolysis alone. Risk of hemolysis from mechanical thrombectomy needs further consideration.

A Review on Joint Carotid Intima-Media Thickness and Plaque Area Measurement in Ultrasound for Cardiovascular/Stroke Risk Monitoring: Artificial Intelligence Framework.

Cardiovascular diseases (CVDs) are the top ten leading causes of death worldwide. Atherosclerosis disease in the arteries is the main cause of the CVD, leading to myocardial infarction and stroke. The two primary image-based phenotypes used for monitoring the atherosclerosis burden is carotid intima-media thickness (cIMT) and plaque area (PA). Earlier segmentation and measurement methods were based on ad hoc conventional and semi-automated digital imaging solutions, which are unreliable, tedious, slow, and not robust. This study reviews the modern and automated methods such as artificial intelligence (AI)-based. Machine learning (ML) and deep learning (DL) can provide automated techniques in the detection and measurement of cIMT and PA from carotid vascular images. Both ML and DL techniques are examples of supervised learning, i.e., learn from "ground truth" images and transformation of test images that are not part of the training. This review summarizes (1) the evolution and impact of the fast-changing AI technology on cIMT/PA measurement, (2) the mathematical representations of ML/DL methods, and (3) segmentation approaches for cIMT/PA regions in carotid scans based for (a) region-of-interest detection and (b) lumen-intima and media-adventitia interface detection using ML/DL frameworks. AI-based methods for cIMT/PA segmentation have emerged for CVD/stroke risk monitoring and may expand to the recommended parameters for atherosclerosis assessment by carotid ultrasound.

Integration of cardiovascular risk assessment with COVID-19 using artificial intelligence.

Artificial Intelligence (AI), in general, refers to the machines (or computers) that mimic "cognitive" functions that we associate with our mind, such as "learning" and "solving problem". New biomarkers derived from medical imaging are being discovered and are then fused with non-imaging biomarkers (such as office, laboratory, physiological, genetic, epidemiological, and clinical-based biomarkers) in a big data framework, to develop AI systems. These systems can support risk prediction and monitoring. This perspective narrative shows the powerful methods of AI for tracking cardiovascular risks. We conclude that AI could potentially become an integral part of the COVID-19 disease management system. Countries, large and small, should join hands with the WHO in building biobanks for scientists around the world to build AI-based platforms for tracking the cardiovascular risk assessment during COVID-19 times and long-term follow-up of the survivors.

Cardiovascular risk assessment in patients with rheumatoid arthritis using carotid ultrasound B-mode imaging.

Rheumatoid arthritis (RA) is a systemic chronic inflammatory disease that affects synovial joints and has various extra-articular manifestations, including atherosclerotic cardiovascular disease (CVD). Patients with RA experience a higher risk of CVD, leading to increased morbidity and mortality. Inflammation is a common phenomenon in RA and CVD. The pathophysiological association between these diseases is still not clear, and, thus, the risk assessment and detection of CVD in such patients is of clinical importance. Recently, artificial intelligence (AI) has gained prominence in advancing healthcare and, therefore, may further help to investigate the RA-CVD association. There are three aims of this review: (1) to summarize the three pathophysiological pathways that link RA to CVD; (2) to identify several traditional and carotid ultrasound image-based CVD risk calculators useful for RA patients, and (3) to understand the role of artificial intelligence in CVD risk assessment in RA patients. Our search strategy involves extensively searches in PubMed and Web of Science databases using search terms associated with CVD risk assessment in RA patients. A total of 120 peer-reviewed articles were screened for this review. We conclude that (a) two of the three pathways directly affect the atherosclerotic process, leading to heart injury, (b) carotid ultrasound image-based calculators have shown superior performance compared with conventional calculators, and (c) AI-based technologies in CVD risk assessment in RA patients are aggressively being adapted for routine practice of RA patients.

Low-Cost Office-Based Cardiovascular Risk Stratification Using Machine Learning and Focused Carotid Ultrasound in an Asian-Indian Cohort.

This study developed an office-based cardiovascular risk calculator using a machine learning (ML) algorithm that utilized a focused carotid ultrasound. The design of this study was divided into three steps. The first step involved collecting 18 office-based biomarkers consisting of six clinical risk factors (age, sex, body mass index, systolic blood pressure, diastolic blood pressure, and smoking) and 12 carotid ultrasound image-based phenotypes. The second step consisted of the design of an ML-based cardiovascular risk calculator-called "AtheroEdge Composite Risk Score 2.0" (AECRS2.0ML) for risk stratification, considering chronic kidney disease (CKD) as the surrogate endpoint of cardiovascular disease. The last step consisted of comparing AECRS2.0ML against the currently utilized office-based CVD calculators, namely the Framingham risk score (FRS) and the World Health Organization (WHO) risk scores. A cohort of 379 Asian-Indian patients with type-2 diabetes mellitus, hypertension, and chronic kidney disease (stage 1 to 5) were recruited for this cross-sectional study. From this retrospective cohort, 758 ultrasound scan images were acquired from the far walls of the left and right common carotid arteries [mean age = 55 ± 10.8 years, 67.28% males, 91.82% diabetic, 86.54% hypertensive, and 83.11% with CKD]. The mean office-based cardiovascular risk estimates using FRS and WHO calculators were 26% and 19%, respectively. AECRS2.0ML demonstrated a better risk stratification ability having a higher area-under-the-curve against FRS and WHO by ~30% (0.871 vs. 0.669) and ~ 20% (0.871 vs. 0.727), respectively. The office-based machine-learning cardiovascular risk-stratification tool (AECRS2.0ML) shows superior performance compared to currently available conventional cardiovascular risk calculators.

Ultrasound-assisted versus conventional catheter-directed thrombolysis for acute pulmonary embolism: A multicenter comparison of patient-centered outcomes.

Both catheter-directed thrombolysis (CDT) and ultrasound-assisted thrombolysis (USAT) are novel treatment modalities for patients presenting with acute pulmonary embolism (PE). The objective of this study was to compare clinical and quality-of-life (QOL) outcomes for patients undergoing either treatment modality. We retrospectively studied 70 consecutive patients treated with either CDT or USAT over 3 years at a multicenter health system. The primary clinical efficacy endpoint was right ventricular systolic pressure (RVSP) reduction post-procedurally. Safety endpoints were mortality and bleeding incidents based on Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria. Long-term QOL was assessed using the 36-Item Short-Form Health Survey (SF-36) via phone interview. Thirty-seven patients (53%) in our study underwent USAT and 33 (47%) patients were treated with conventional CDT. Among all patients studied, 96% had echocardiographic evidence for right ventricular strain on admission. Mean RVSP decreased by 18 ± 13 mmHg in the USAT group post-procedurally as compared to 14 ± 16 mmHg in the CDT group, without significant difference between groups ( p = 0.31). Rates of moderate and severe bleeding were largely identical between USAT and CDT groups (USAT: 3%; CDT: 0%; p = 0.09). There was no death in either group during admission. At long-term follow-up, there was no significant difference in QOL between both treatment modalities in all eight functional domains of SF-36. Our retrospective study demonstrated using USAT over conventional CDT for acute submassive or massive PE did not yield additional clinical, safety, or long-term QOL benefit.

Full Drug-Eluting Stent Jacket: Two-Year Results of a Single-Center Experience With Zilver PTX Stenting for Long Lesions in the Femoropopliteal Arteries.

PURPOSE: To evaluate the 1- and 2-year patency and reintervention rates with the Zilver PTX drug-eluting stent (DES) in long complex femoropopliteal disease. METHODS: A retrospective review was conducted of 89 consecutive patients (mean age 68.7±9.8 years; 86 men) with femoropopliteal occlusive disease (Rutherford category 2-6) treated with the Zilver PTX between December 2012 and December 2013. Mean lesion length for the entire cohort was 24.2±11.3 cm (median 24.0, range 4-48). The patient population was dichotomized into a short lesion (≤20 cm) group (n=41; mean lesion length 13.3±5.6 cm) and the full DES jacket (>20 cm) group (n=48; mean lesion length 33.0±6.5 cm). Primary endpoints were duplex-derived restenosis (peak systolic velocity ratio >2.5), clinically driven reintervention, and major amputation. RESULTS: The incidence of restenosis was lower in the short lesion group at 1 year (19% vs 40% for the longer lesions, p=0.050) and 2 years (39% vs 54%, respectively; p=0.331). The short lesion group had significantly lower rates of reintervention at both 1 year (2% vs 21% in long lesions, p=0.009) and 2 years (12% vs 33%, p=0.019). CONCLUSION: Treatment of femoropopliteal lesions >20 cm with the Zilver PTX appears to be a clinically effective therapy for patients with symptomatic peripheral artery disease. However, there is an increase in restenosis and a need for reintervention that continues to progress up to 2 years.

Characteristics, treatment patterns and outcomes of patients presenting with venous thromboembolic events after knee arthroscopy in the RIETE Registry.

Knee arthroscopy is the most common orthopedic procedure worldwide. While incidence of post-arthroscopy venous thromboembolic events (VTE) is low, treatment patterns and patient outcomes have not been described. Patients from the "Registro Informatizado Enfermedad TromboEmbolica" who had confirmed post-arthroscopy VTE were compared to patients with provoked, post bone-fracture, and to patients with unprovoked VTE. Baseline characteristics, presenting signs and symptoms, treatment and outcomes including recurrent VTE, bleeds or death were compared. A total of 101 patients with post-arthroscopy VTE and 19,218 patients with unprovoked VTE were identified. Post-arthroscopy patients were younger (49.5 vs. 66 years, P < 0.0001) and had less history of VTE [5.9% vs. 20%, OR 0.26 (0.11-0.59)]. Among patients with isolated DVT, there were fewer proximal DVT in the post-arthroscopy group [40% vs. 86%, OR 0.11 (0.06-0.19)]. Treatment duration was shorter in the post-arthroscopy group (174 ± 140 vs. 311 ± 340 days, P < 0.0001) and more often with DOAC [OR 3.67 (1.95-6.89)]. Recurrent VTE occurred in 6.18 (1.96-14.9) and 11.9 (11.0-12.8) per 100 patient years [HR 0.52 (0.16-1.26)] after treatment in the post-arthroscopy and unprovoked groups, respectively. Recurrent VTE occurred in 5.17 (1.31-14.1) per 100 patient years in a separate post bone-fracture group (n = 147), also not statistically different than the post-arthroscopy recurrence rate. After anticoagulation cessation, some patients post-knee arthroscopy develop VTE. While our small sample size precludes drawing firm conclusions, this signal should warrant further research into the optimal treatment duration for these patients, as some patients may be at increased risk for long-term recurrence.

Use of Polidocanol Endovenous Microfoam to Improve Hemodynamics and Symptomology in Patients with Challenging Clinical Presentations: A Case Series.

BACKGROUND: Chronic venous insufficiency (CVI) is a widely prevalent condition. Saphenous venous reflux is the most common underlying pathology that leads to CVI. Endovenous thermal ablations (ETA) are the current gold standard. However, some patients present with some unique challenges making ETA less ideal. Nonthermal nontumescent therapies could be considered as alternative therapy in these patients. METHODS: We performed a retrospective review of treatment effects with United States Food and Drug Administration-approved polidocanol endovenous microfoam (PEM; Varithena® 1%) on venous symptomology in 10 (n = 10) C3-C6 patients with CVI and concomitant complex disease/pathology that limited the use of ETA. The pathology included risk of bruising or bleeding, severe lipodermatosclerosis, hidradenitis suppurativa, chronic fibrosis of the vein from prior superficial thrombosis, risk for nerve injury, and failed prior ETA. Before treatment, all patients underwent a venous incompetence study by duplex ultrasound (DUS). Preprocedure pain, symptoms, and Venous Clinical Severity Scores (VCSSs) were recorded. Clinical assessments and DUS were performed 4 days, 6 weeks, 6 months, and 1 year after treatment. RESULTS: DUS demonstrated reflux in the great saphenous vein (GSV), anterior accessory GSV, and/or the small saphenous vein. Pain scores and VCSS were reduced 4 days and 6 weeks after treatment. These lower scores were maintained for up to 1 year after treatment. CONCLUSIONS: PEM use in C3-C6 patients resulted in successful improvement in VCSS, CVI symptoms, and wound healing among patients in whom ETA was not considered to be the optimal therapy.

Sex differences in utilization and outcomes of catheter-directed thrombolysis in patients with proximal lower extremity deep venous thrombosis - Insights from the Nationwide Inpatient Sample.

Catheter-directed thrombolysis (CDT) is being increasingly used for the treatment of proximal lower extremity (LE) deep venous thrombosis (DVT). However, sex differences in utilization and safety outcomes of CDT in these patients are unknown. The Nationwide Inpatient Sample (NIS) database was used to identify all patients with a principal discharge diagnosis of proximal LE or caval DVT who underwent CDT between January 2005 and December 2011 in the United States. We evaluated the comparative safety outcomes of CDT among a propensity-matched group of 1731 men versus 1731 women. Among 108,243 patients with proximal LE or caval DVT, 4826 patients (4.5%) underwent CDT. Overall, women underwent CDT less often compared to men (4.1% vs 4.9%, p<0.01, respectively). The rates of CDT increased between 2005 and 2011 for both women (2.1% to 5.9%, p<0.01) and men (2.5% to 7.5%, p<0.01). There was no significant difference in in-hospital mortality (1.2% vs 1.3%, p=0.76). Women were noted to have higher rates of blood transfusions (11.7% vs 8.8%, p<0.01), but lower rates of intracranial hemorrhage (0.5% vs 1.2%, p=0.03) and gastrointestinal bleeding (0.9% vs 2.2%, p<0.01) compared with men. Women were more likely to undergo inferior vena cava filter placement (37.0% vs 32.1%, p<0.01). In this large nationwide cohort, women with proximal DVT were less likely to receive CDT compared to men. Although mortality rates were similar, women were noted to have higher blood transfusion rates while men had more episodes of intracranial and gastrointestinal bleeding.

A randomized study of the safety and efficacy of fondaparinux versus placebo in the prevention of venous thromboembolism after coronary artery bypass graft surgery.

UNLABELLED: Venous thromboembolism (VTE) after coronary artery bypass graft (CABG) surgery may increase the postoperative morbidity and mortality. Therefore, we examined the current postoperative need for prophylactic antithrombotic therapy after CABG surgery. METHODS: This randomized, placebo-controlled, double-blind study was designed to compare the safety and efficacy of fondaparinux versus placebo in the prevention of VTE after CABG surgery. Between March 2010 and January 2013, 78 patients free from preoperative deep vein thrombosis (DVT) were enrolled, of whom 37 were randomly assigned to placebo and 41 to treatment with fondaparinux. The primary study end point was a composite, up to day 11, of (a) cumulative incidence of all VTE events, defined as symptomatic and asymptomatic DVT, and fatal and nonfatal pulmonary embolisms (efficacy end point), and (b) cumulative incidence of major hemorrhages (safety end point). RESULTS: A single asymptomatic DVT of a lower extremity was detected by duplex ultrasound at the time of discharge from the hospital in the placebo-treated group, and a single major postoperative hemorrhage occurred in the fondaparinux-treated group. CONCLUSIONS: The incidence of postprocedural asymptomatic DVT in this sample of patients undergoing CABG surgery was low. The overall incidence of DVT in the control and investigational treatment groups was similar. Our results showed no benefit of prophylactic postoperative fondaparinux in this population. These findings are congruent with other published studies and provide additional support for recent recommendations not to routinely use anticoagulant prophylaxis after cardiac surgery.