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Numerous randomised clinical trials and real-world studies have supported the safety of paclitaxel-coated devices for the treatment of femoropopliteal occlusive disease. However, a 2018 summary-level meta-analysis suggested an increased mortality risk for paclitaxel-coated devices compared with uncoated control devices. This study presents an updated analysis of deaths using the most complete and current data available from pivotal trials of paclitaxel-coated versus control devices. Ten trials comparing paclitaxel-coated versus control devices were included in a patient-level pooled analysis. Cox regression models were used to evaluate the effect of paclitaxel exposure on risk of death in both intention-to-treat (ITT; primary analysis) and three as-treated analysis sets accounting for treatment group crossover at the index procedure and over time. The effect of paclitaxel dose and baseline covariates were also evaluated. A total of 2666 participants were included with a median follow-up of 4·9 years. No significant increase in deaths was observed for patients treated with paclitaxel-coated devices. This was true in the ITT analysis (hazard ratio [HR] 1·14, 95% CI 0·93–1·40), the as-treated analysis (HR 1·13, 95% CI 0·92–1·39), and in two crossover analyses: 1·07 (0·87–1·31) when late crossovers were censored and 1·04 (0·84–1·28) when crossovers were analysed from the date of paclitaxel exposure. There was no significant effect of paclitaxel dose on mortality risk. This meta-analysis found no association between paclitaxel-coated device exposure and risk of death, providing reassurance to patients, physicians, and regulators on the safety of paclitaxel-coated devices. Becton Dickinson, Boston Scientific, Cook, Medtronic, Philips, Surmodics, and TriReme Medical.

Although COVID-19 is most well known for causing substantial respiratory pathology, it can also result in several extrapulmonary manifestations. These conditions include thrombotic complications, myocardial dysfunction and arrhythmia, acute coronary syndromes, acute kidney injury, gastrointestinal symptoms, hepatocellular injury, hyperglycemia and ketosis, neurologic illnesses, ocular symptoms, and dermatologic complications. Given that ACE2, the entry receptor for the causative coronavirus SARS-CoV-2, is expressed in multiple extrapulmonary tissues, direct viral tissue damage is a plausible mechanism of injury. In addition, endothelial damage and thromboinflammation, dysregulation of immune responses, and maladaptation of ACE2-related pathways might all contribute to these extrapulmonary manifestations of COVID-19. Here we review the extrapulmonary organ-specific pathophysiology, presentations and management considerations for patients with COVID-19 to aid clinicians and scientists in recognizing and monitoring the spectrum of manifestations, and in developing research priorities and therapeutic strategies for all organ systems involved. Recent clinical observations have prompted clinicians to think of COVID-19 as being more than a respiratory disease.

Despite recent advances in diagnosis and treatment, atherosclerotic coronary artery diseases remain a leading cause of death worldwide. Various imaging modalities and metrics can detect lesions and predict patients at risk; however, identifying unstable lesions is still difficult. Current techniques cannot fully capture the complex morphology-modulated mechanical responses that affect plaque stability, leading to catastrophic failure and mute the benefit of device and drug interventions. Finite Element (FE) simulations utilizing intravascular imaging OCT (Optical Coherence Tomography) are effective in defining physiological stress distributions. However, creating 3D FE simulations of coronary arteries from OCT images is challenging to fully automate given OCT frame sparsity, limited material contrast, and restricted penetration depth. To address such limitations, we developed an algorithmic approach to automatically produce 3D FE-ready digital twins from labeled OCT images. The 3D models are anatomically faithful and recapitulate mechanically relevant tissue lesion components, automatically producing morphologies structurally similar to manually constructed models whilst including more minute details. A mesh convergence study highlighted the ability to reach stress and strain convergence with average errors of just 5.9% and 1.6% respectively in comparison to FE models with approximately twice the number of elements in areas of refinement. Such an automated procedure will enable analysis of large clinical cohorts at a previously unattainable scale and opens the possibility for in-silico methods for patient specific diagnoses and treatment planning for coronary artery disease. •Patient-specific coronary lesion stability can be accurately determined.•3D image reconstructed from interpolating CNN labeled images.•Mesh generated with refinement and boundary conditions.•Finite element analysis (FEA) captures structural micromechanics.•A fully-automated digital twin generated from OCT intravascular images.

In a trial involving patients with infrapopliteal artery disease, the use of a drug-eluting resorbable scaffold was superior to angioplasty in reducing reintervention and maintaining patency at 1 year.

Drug-eluting resorbable scaffolds (DRS) are conceptually attractive for treatment of peripheral arterial disease, particularly below-the-knee. MOTIV is a peripheral variant of REVA Medical’s well-established, radiopaque tyrosine-polycarbonate (Tyrocore) sirolimus-eluting DRS. The purpose of this study was to provide imaging and histopathologic data on vascular response to MOTIV in porcine peripheral arteries. MOTIV scaffolds (3.0 or 3.5 × 12/24/36/48/60 mm) were implanted in 20 internal iliac arteries of 9 Yorkshire swine. At 30 and 90 days, vascular stenosis, strut coverage, and strut apposition were characterized using optical coherence tomography. Scaffold structure and vascular healing were assessed by histopathology and scanning electron microscopy. At termination, all vessels remained patent. The average neointimal thickness was 0.22 ± 0.05 mm in Group 1 (30 days) and 0.18 ± 0.10 mm in Group 2 (90 days); the percent area stenosis was 28 ± 6% and 24 ± 11%, respectively. All struts were fully covered by neointima. No malapposition, stent fracture or late strut discontinuity was observed. Adequate vessel wall healing at both time points was characterized by a typically fully mature neointima and complete reendothelialization at all sites. No unresorbed luminal thrombus was observed. The inflammation scores were low for all vessels on both time points, except for one animal. The average inflammation (excluding multinucleated giant cells [MNGCs]) was 0.6 (MNGCs score was 0.9) for the stented vessel segments at 30 days and 0.8 (MNGCs score of 1.0) at 90 days. Implantation of the MOTIV up to 60 mm long in small-caliber peripheral arteries of swine resulted in 100% patency rate and adequate vascular healing at 30-day and 90-day timepoints. The Tyrocore-based DRS retained the necessary structural integrity throughout the course of the study and confirmed their favorable biocompatibility in small-caliber porcine peripheral arteries.

•STORM-PE is an RCT evaluating CAVT in PE.•STORM-PE includes intermediate high-risk acute PE patients.•The primary endpoint is a change in RV/LV ratio at 48 hours.•Other endpoints are 7-day MAEs, 90-day mortality, and symptomatic PE recurrence.•STORM-PE will also assess patient-centered 90-day functional and QoL outcomes. Therapeutic anticoagulation (AC) is standard care for pulmonary embolism (PE). Endovascular therapy with mechanical thrombectomy (MT) is commonly performed for PE and well-studied in single-arm trials. The efficacy benefit of MT over AC alone in a randomized fashion remains unstudied. STORM-PE (ClinicalTrials.gov Identifier: NCT05684796) is a post-market, international, open-label trial conducted in partnership with The Pulmonary Embolism Response Team Consortium. Up to 100 patients with confirmed acute intermediate-high-risk PE demonstrated by right ventricular (RV) dysfunction with a right-to-left ventricular (RV/LV) ratio ≥1.0 and elevated cardiac biomarkers will be randomized 1:1 to receive AC alone or AC plus computer assisted vacuum thrombectomy (CAVT) with the Indigo Aspiration System (Penumbra Inc.). The primary outcome is a mean change in RV/LV ratio at 48 hours, assessed by computed tomographic pulmonary angiography (CTPA) and adjudicated by a blinded, independent imaging Core Lab. Additional endpoints are composite major adverse events, functional outcomes (6-minute walk test, New York Heart Association classification, post-venous thromboembolism functional status scale, modified Medical Research Council Dyspnea Scale, Borg Scale), quality of life (Pulmonary Embolism Quality of Life Questionnaire and EQ-5D-5L), mortality, and symptomatic PE recurrence through 90 days. A Clinical Events Committee will adjudicate adverse events for causality and attribution and an independent Data Safety Monitoring Board will oversee the study. STORM-PE is funded by Penumbra Inc. The STORM-PE trial will help inform future guidelines and standards of care related to frontline treatment using mechanical thrombectomy with CAVT for patients with acute intermediate-high-risk PE. STORM-PE, NCT05684796, is registered at https://clinicaltrials.gov/study/NCT05684796.

Pulmonary embolism (PE) is the third most common cause of cardiovascular death; however, gender disparities in PE remain understudied. All PE cases at a single institution between January 2013 and June 2019 were retrospectively reviewed. The clinical presentation, treatment modalities, and outcomes were compared between men and women using univariate and multivariate analyses adjusting for differences in baseline characteristics. A total of 1,345 patients were diagnosed with acute PE, of whom 56.3% were women (n = 757). Women had a significantly higher mean body mass index (29.4 vs 28.4) and a higher frequency of hypertension (53% vs 46%) and hormone use (6.6% vs 0%; all p <0.02). Men had a higher frequency of smoking (45% vs 33%, p <0.0001). Women had significantly lower PE severity index classifications (p = 0.0009). The rates of intensive care unit admission, vasopressor requirements, extracorporeal membrane oxygenation cannulation, and mechanical ventilation were similar between the genders. There was no significant difference in the treatment modality used between the genders. Although the risk factors and PE severity index class differed between the genders, there was no significant difference in resource utilization or treatment modality. Gender was also not a significant predictor of in-hospital mortality, moderate or severe bleeding, increased length of stay, or readmission in the study population.

The coronavirus disease 2019 (COVID-19) can result in a hyperinflammatory state, leading to acute respiratory distress syndrome (ARDS), myocardial injury, and thrombotic complications, among other sequelae. Statins, which are known to have anti-inflammatory and antithrombotic properties, have been studied in the setting of other viral infections, but their benefit has not been assessed in COVID-19. This is a retrospective analysis of patients admitted with COVID-19 from February 1 st through May 12 th , 2020 with study period ending on June 11 th , 2020. Antecedent statin use was assessed using medication information available in the electronic medical record. We constructed a multivariable logistic regression model to predict the propensity of receiving statins, adjusting for baseline sociodemographic and clinical characteristics, and outpatient medications. The primary endpoint includes in-hospital mortality within 30 days. A total of 2626 patients were admitted during the study period, of whom 951 (36.2%) were antecedent statin users. Among 1296 patients (648 statin users, 648 non-statin users) identified with 1:1 propensity-score matching, statin use is significantly associated with lower odds of the primary endpoint in the propensity-matched cohort (OR 0.47, 95% CI 0.36–0.62, p  < 0.001). We conclude that antecedent statin use in patients hospitalized with COVID-19 is associated with lower inpatient mortality. Statins, which have anti-inflammatory and antithrombotic properties, could have effects in COVID-19 patients. Here, the authors find in a retrospective analysis of patients hospitalized with COVID-19 that antecedent statin use is associated with lower inpatient mortality.

PurposeAccurate measurement of renal mass size is crucial in the management of renal cancer. With the burdensome cost of imaging yet its need for management, a better understanding of the variability among patients when determining mass size remains of urgent importance. Current guidelines on optimal imaging are limited, especially with respect to body mass index (BMI). The aim of this study is to discern which modalities accurately measure renal mass size and whether BMI influences such accuracy.MethodsA multi-institutional chart review was performed for adult patients undergoing partial or radical nephrectomy between 2018 and 2021, with 236 patients ultimately included. Patients were categorized by BMI (BMI 1: 18.5–24.9, BMI 2: 25–29.9, BMI 3: 30–34.9, and BMI 4: ≥ 35). The greatest mass lengths were compared between the pathology report and the following: computerized tomography (CT), renal ultrasound, and magnetic resonance imaging (MRI).ResultsThe difference between greatest length on CT with contrast and MRI were significantly different when compared to pathologic measurement. BMI groups 3 and 4 were found to have a significant difference in size estimates compared to BMI 2 for CT with contrast. No difference was found between size estimates by BMI group for any other imaging modality.ConclusionCT with contrast becomes less accurate at estimating mass size for patients with BMI > 30. While contrast-enhanced CT remains a vital imaging modality for tissue enhancement in the context of unknown renal masses, caution must be used for mass size estimation in the obese population.

Regulatory approval of immune checkpoint inhibitors (ICIs) was based on results of large, randomized clinical trials, resulting in limited outcomes data in patient cohorts typically underrepresented in such trials. The objective of this study was to evaluate the efficacy and safety of ICIs in these unique patient cohorts. This is a multicenter, retrospective analysis of real-world data at six academic and community clinics in the United States from 1 January 2011 to 1 April 2018. Patients were included if they had received at least one cycle of ICI treatment. Unique patient cohorts included age > 75 years, non-White race, positive smoking history, ECOG performance status (PS) ≥ 2, BMI ≥ 30 kg/m2, autoimmune diseases (AIDs), chronic viral infections (CVI), extensive prior lines of therapy (LOTs), or >three metastatic sites. Immune-related adverse events (irAEs), overall survival (OS), and time to treatment failure were evaluated in the entire cohort and in NSCLC patients treated with PD-(L)1 monotherapy. Outcomes and their association with unique patient cohorts were compared on univariate analysis and multivariate analysis to those without a particular characteristic in the entire NSCLC PD-(L)1 monotherapy cohorts. In total, 1453 patients were included: 56.5%—smokers, 30.4%—non-White, 22.8%—elderly, 20.8%—ECOG PS ≥ 2, 15.7%—history of AIDs, and 4.7%—history of CVI. The common ICIs were nivolumab (37.1%) and pembrolizumab (22.2%). Black patients, compared to White patients, experienced fewer irAEs (OR 0.54, p < 0.001). An ECOG PS of ≥2 (HR = 2.01, p < 0.001) and an increased number of previous LOTs were associated with poor OS (the median OS of 26.2 vs. 16.2 vs. 9.6 months for one vs. two vs. three prior LOTs, p < 0.001). The above results were confirmed in anti-PD-(L)1 monotherapy non-small cell lung cancer patients (n = 384). Overall, ICIs were safe and efficacious in these typically underrepresented patient cohorts. We noted ECOG PS ≥ 2 and an increased prior LOTs were associated with poor ICI efficacy, and Black patients, compared to White patients, experienced fewer irAEs.