Monoclonal Gammopathy of Undetermined Significance and Associated Cardiovascular Outcomes in a Hospital Setting-A Fresh Perspective.

There is a paucity of data on the cardiovascular implications of monoclonal gammopathy of undetermined significance, especially among hospitalized patients. Our study aimed to investigate the association between MGUS and cardiovascular outcomes in a hospital setting using the National Inpatient Sample database. MGUS patients were sampled using ICD-10 codes. The patients were stratified into two cohorts based on the presence or absence of MGUS. Comorbidities and cardiovascular outcomes were collected using ICD 10 DM codes. CV outcomes were evaluated before and after 1:1 matching for age, gender, and race. Furthermore, a sensitivity analysis was performed on the matched population, which excluded patients with diabetes mellitus, prior myocardial infarction, chronic kidney disease (stages 3-5), dialysis, hypertension, obesity, metabolic syndrome, cancer, antiplatelets, and oral anticoagulant use and was adjusted for smoking, dyslipidemia, and aspirin use to evaluate the cardiovascular outcomes. MGUS patients had more heart failure, atrial fibrillation, venous thromboembolism, aortic aneurysm, aortic stenosis, aortic regurgitation, mitral stenosis, mitral regurgitation, conduction disorder, cor pulmonale, peripheral vascular disease, and acute myocardial infarction. After matching, MGUS was associated with heart failure, atrial fibrillation, venous thromboembolism, aortic stenosis, mitral regurgitation, conduction disorder, cor pulmonale, and peripheral vascular disease. MGUS was linked to a wide spectrum of cardiovascular diseases in an inpatient setting. Further studies are needed to formulate appropriate recommendations for the screening and management of cardiovascular complications in individuals with MGUS.

Mechanical Thrombectomy for High-Risk Pulmonary Embolism: Insights From the US Cohort of the FLASH Registry.

Background: Acute mortality for high-risk, or massive, pulmonary embolism (PE) is almost 30% even when treated using advanced therapies. This analysis assessed the safety and effectiveness of mechanical thrombectomy (MT) for high-risk PE. Methods: The prospective, multicenter FlowTriever All-comer Registry for Patient Safety and Hemodynamics (FLASH) study is designed to evaluate real-world PE patient outcomes after MT with the FlowTriever System (Inari Medical). In this study, acute outcomes through 30 days were evaluated for the subset of patients with high-risk PE as determined by the sites and following European Society of Cardiology guidelines. An independent medical monitor adjudicated adverse events (AEs), including major AEs: device-related mortality, major bleeding, or intraprocedural device-related or procedure-related AEs. Results: Of the 799 patients in the US cohort, 63 (7.9%) were diagnosed with high-risk PE; 30 (47.6%) patients showed a systolic blood pressure <90 mm Hg, 29 (46.0%) required vasopressors, and 4 (6.3%) experienced cardiac arrest. The mean age of patients with high-risk PE was 59.4 ± 15.6 years, and 34 (54.0%) were women. At baseline, 45 (72.6%) patients were tachycardic, 18 (54.5%) showed elevated lactate levels of ≥2.5 mM, and 21 (42.9%) demonstrated depressed cardiac index of <2 L/min/m2. Immediately after MT, heart rate improved to 93.5 ± 17.9 bpm. Twenty-five (42.4%) patients did not require an overnight stay in the intensive care unit, and no mortalities or major AEs occurred through 48 hours. Moreover, no mortalities occurred in 61 (96.8%) patients followed up through the 30-day visit. Conclusions: In this cohort of 63 patients with high-risk PE, MT was safe and effective, with no acute mortalities reported. Further prospective data are needed in this population.

The Role of IVC Filters in the Management of Acute Pulmonary Embolism.

Venous thromboembolism (VTE), comprising deep venous thrombosis (DVT) and pulmonary embolism (PE), is a prevalent cardiovascular condition, ranking third globally after myocardial infarction and stroke. The risk of VTE rises with age, posing a growing concern in aging populations. Acute PE, with its high morbidity and mortality, emphasizes the need for early diagnosis and intervention. This review explores prognostic factors for acute PE, categorizing it into low-risk, intermediate-risk, and high-risk based on hemodynamic stability and right ventricular strain. Timely classification is crucial for triage and treatment decisions. In the contemporary landscape, low-risk PE patients are often treated with Direct Oral Anticoagulants (DOACS) and rapidly discharged for outpatient follow-up. Intermediate- and high-risk patients may require advanced therapies, such as systemic thrombolysis, catheter-directed thrombolysis, mechanical thrombectomy, and IVC filter placement. The latter, particularly IVC filters, has witnessed increased usage, with evolving types like retrievable and convertible filters. However, concerns arise regarding complications and the need for timely retrieval. This review delves into the role of IVC filters in acute PE management, addressing their indications, types, complications, and retrieval considerations. The ongoing debate surrounding IVC filter use, especially in patients with less conventional indications, reflects the need for further research and data. Despite complications, recent studies suggest that clinically significant issues are rare, sparking discussions on the appropriate and safe utilization of IVC filters in select PE cases. The review concludes by highlighting current trends, gaps in knowledge, and potential avenues for advancing the role of IVC filters in future acute PE management.

Heart failure - An unexplored risk factor for infective endocarditis after pacemaker implantation.

BACKGROUND: With the widespread use of permanent pacemakers (PPM), and increased mortality associated with pacemaker endocarditis, it is essential to evaluate comorbidities that could potentially increase the risk of infective endocarditis (IE). Heart failure (HF), a common comorbidity, has not been well studied as an independent risk factor for development of IE in individuals with PPM. METHODS: The US National Inpatient Sample database was used to sample individuals with PPM. Patients with concomitant implantable cardioverter defibrillator, acute heart failure, history of endocarditis, intravenous drug use, prosthetic heart valves, or central venous catheter infection were excluded. Propensity matching was performed to match patients with and without HF. Pre- and post-match logistic regression was performed to assess HF as an independent risk factor for IE. A subgroup analysis was performed comparing IE rates between patients with HF with reduced (HFrEF) vs preserved (HFpEF) ejection fraction. RESULTS: Out of 333,571 patients with PPM included in the study, 121,862 (37 %) had HF. HF patients were older and had a higher prevalence of females. All comorbidities except for dental disease and cancer were more prevalent in the HF group. Patients with HF were 1.30 times more likely to develop IE [OR: 1.30 (1.16-1.47); p < 0.001]. The two cohorts were then matched for age, gender, and 20 comorbidities using a 1:1 propensity score matching algorithm. After matching, HF was still independently associated with increased risk of IE [OR: 1.62 (1.36-1.93); p < 0.001]. In our sub-group analysis, HFrEF and HFpEF patients had similar IE rates. CONCLUSION: In PPM population, HF was associated with an increased risk of IE compared to those without HF. We hypothesize that HF being a low-flow and high-inflammatory state might have contributed to this increased risk. Larger studies are required to corroborate our findings and evaluate the need for antimicrobial prophylaxis for this population.

Association Between Diagnosis-to-Limb Revascularization Time and Clinical Outcomes in Outpatients With Chronic Limb-Threatening Ischemia: Insights From the CLIPPER Cohort.

BACKGROUND: The extent and consequences of ischemia in patients with chronic limb-threatening ischemia (CLTI) may change rapidly, and delays from diagnosis to revascularization may worsen outcomes. We sought to describe the association between time from diagnosis to endovascular lower extremity revascularization (diagnosis-to-limb revascularization [D2L] time) and clinical outcomes in outpatients with CLTI. METHODS AND RESULTS: In the CLIPPER cohort, comprising patients between 66 and 86 years old diagnosed with CLTI betweeen 2010 and 2019, we used Medicare claims data to identify patients who underwent outpatient endovascular revascularization within 180 days of diagnosis. We described the risk-adjusted association between D2L time and clinical outcomes. Among 1 130 065 patients aged between 66 and 86 years with CLTI, 99 221 (8.8%) underwent outpatient endovascular lower extremity revascularization within 180 days of their CLTI diagnosis. Among patients with D2L time <30 days, there was no association between D2L time and all-cause death or major lower extremity amputation. However, among patients with D2L time >30 days, each additional 10-day increase in D2L time was associated with a 2.5% greater risk of major amputation (hazard ratio, 1.025 [95% CI, 1.014-1.036]). There was no association between D2L time and all-cause death. CONCLUSIONS: A delay of >30 days from CLTI diagnosis to lower extremity endovascular revascularization was associated with an increased risk of major lower extremity amputation among patients undergoing outpatient endovascular revascularization. Improving systems of care to reduce D2L time could reduce amputations.

Unveiling the Hidden Stroke Threat in Patients With Atrial Fibrillation and Primary Hyperparathyroidism.

Recent American College of Cardiology (ACC), American Heart Association (AHA), American College of Clinical Pharmacy (ACCP), and Heart Rhythm Society (HRS) guidelines suggest that patients with atrial fibrillation (AF) at intermediate to low annual risk of ischemic stroke can benefit from consideration of factors that might modify their risk of stroke. The role of nontraditional risk factors, such as primary hyperparathyroidism (PHPT), remains unexplored. In our study, we investigated the potential association between PHPT and the risk of ischemic stroke in patients with AF. Using data from the Nationwide Inpatient Sample Database, a retrospective cohort study focused on the adult population with AF, we stratified the participants based on PHPT presence. Demographic information, co-morbidities, and hospitalization details were extracted using International Classification of Diseases, Tenth revision codes. Propensity score matching was applied, encompassing over 20 confounding variables, including the risk factors outlined in the CHA2DS2-VASc (Congestive heart failure (C), Hypertension (H), Age ≥75 years (A2), Diabetes Mellitus (D), Stroke/Transient Ischemic Attack (TIA)/Thromboembolism (S2), Vascular disease (V), Age 65-74 years (A), Sex category [female] (Sc)) score. Multivariate logistic regression analysis was performed after matching to assess the independent impact of PHPT as an ischemic stroke risk factor. A total of 2,051 of the identified 395,249 patients with AF had PHPT. The PHPT group had an average age of 74 years and consisted of more women (66.1% vs 53.0%). After matching, it was observed that the PHPT group had longer hospital stays (5 vs 4 days) and higher hospitalization charges ($45,126 vs $36,644). This group exhibited higher rates of ischemic stroke (6.0% vs 4.4%) and mortality (6.3% vs 4.9%). The adjusted outcomes showed a 1.4-fold increased risk for ischemic stroke and a 1.32-fold increased risk for mortality in the PHPT cohort. The subgroup analysis showed a higher incidence of mortality in men with a high CHA2DS2-VASc score. In conclusion, this study highlights a marked association between PHPT and ischemic stroke in patients with AF, independent of the conventional CHA2DS2-VASc score. The potential mechanisms implicated include vascular changes, cardiac dysfunction, and coagulation cascade alterations. The presence of PHPT should be taken into consideration when deciding the assessment of thromboembolic risk.

Advanced Treatment of Hemodynamically Unstable Acute Pulmonary Embolism and Clinical Follow-up.

High-risk acute pulmonary embolism (PE), defined as acute PE associated with hemodynamic instability, remains a significant contributor to cardiovascular morbidity and mortality in the United States and worldwide. Historically, anticoagulant therapy in addition to systemic thrombolysis has been the mainstays of medical therapy for the majority of patients with high-risk PE. In efforts to reduce the morbidity and mortality, a wide array of interventional and surgical therapies has been developed and employed in the management of these patients. However, the most recent guidelines for the management of PE have reserved the use of these advanced therapies in scenarios where thrombolytic therapy plus anticoagulation are unsuccessful. This is due largely to the lack of prospective, randomized studies in this population. Stemming from this, the approach to treatment of these patients varies widely depending on institutional experience and resources. Furthermore, morbidity and mortality remain unacceptably high in this population, with estimated 30-day mortality of at least 30%. As such, development of a standardized approach to treatment of these patients is paramount to improving outcomes. Early and accurate risk stratification in conjunction with a multidisciplinary team approach in the form of a PE response team is crucial. With the advent of novel therapies for the treatment of acute PE, in addition to the growing availability of and familiarity with mechanical circulatory support systems, such a standardized approach may now be within reach.

The Impact of Age on the Epidemiology and Cost of Atrial Fibrillation Hospitalizations.

Atrial fibrillation (AF) is the most common arrhythmia and increases with age. This rising prevalence of AF is contributing to an increasing public health and economic burden. The 2018 Healthcare Cost and Utilization Project National Inpatient Sample dataset was used. All patients ≥15 years with a principal discharge diagnosis of AF were included. The patient population was divided into an "older" cohort (aged ≥65 years) and a "younger" (aged <65 years). Desired outcomes included hospital length of stay, discharge disposition, hospital charges, and in-hospital mortality. A generalized linear mixed model was used to calculate hospitalization rates for the "younger" and "older" groups. We identified 896,328 AF hospitalizations. Younger patients (18.1%) were more likely to be male (65.5% vs 49.9%), to smoke (21.6% vs 6.1%), and to use alcohol (9.7% vs 2.1%). Older patients were more likely to have heart failure (49.6% vs 43.9%) and hypertension (84.6% vs 76.1%). Hospitalization rates increased with increasing age groups. Older patients had higher in-hospital mortality (4.6% vs 2.9%) and were more likely to be discharged to another facility (31.6% vs 13.2%). AF hospitalization rates vary between hospitals across the United States. Hospital divisions with greater than expected admissions for AF, when compared with the national mean, were driven by higher "older" patient hospitalizations. In conclusion, older patients account for most AF hospitalizations. Older patients have higher AF morbidity and mortality. Hospitalization rates for AF increase with increasing increments of age.

Mortality differences by race over 20 years in individuals with peripheral artery disease.

INTRODUCTION: Racial disparities exist in patients with peripheral artery disease (PAD), with Black individuals having worse PAD-specific outcomes. However, mortality risk in this population has been mixed. As such, we sought to evaluate all-cause mortality by race among individuals with PAD. METHODS: We analyzed data from the National Health and Nutrition Examination Survey (NHANES). Baseline data were obtained from 1999 to 2004. Patients with PAD were grouped according to self-reported race. Multivariable Cox proportional hazards regression was performed to calculate adjusted hazard ratios (HR) by race. A separate analysis was performed to study the effect of burden of social determinants of health (SDoH) on all-cause mortality. RESULTS: Of 647 individuals identified, 130 were Black and 323 were White. Black individuals had more premature PAD (30% vs 20%, p < 0.001) and a higher burden of SDoH compared to White individuals. Crude mortality rates were higher in Black individuals in the 40-49-year and 50-69-year age groups compared to White individuals (6.7% vs 6.1% and 8.8% vs 7.8%, respectively). Multivariable analysis demonstrated that Black individuals with both PAD and coronary artery disease (CAD) had a 30% higher hazard of death over 20 years compared to White individuals (HR = 1.3, 95% CI: 1.0-2.1). The cumulative burden of SDoH marginally (10-20%) increased the risk of all-cause mortality. CONCLUSIONS: In a nationally representative sample, Black individuals with PAD and CAD had higher rates of mortality compared to their White counterparts. These findings add further proof to the ongoing racial disparities among Black individuals with PAD and highlight the necessity to identify ways to mitigate these differences.

Prevalence and Predictors of Cardiogenic Shock in Intermediate-Risk Pulmonary Embolism: Insights From the FLASH Registry.

BACKGROUND: Patients with acute pulmonary embolism (PE) and hypotension (high-risk PE) have high mortality. Cardiogenic shock can also occur in nonhypotensive or normotensive patients (intermediate-risk PE) but is less well characterized. OBJECTIVES: The authors sought to evaluate the prevalence and predictors of normotensive shock in intermediate-risk PE. METHODS: Intermediate-risk PE patients in the FLASH (FlowTriever All-Comer Registry for Patient Safety and Hemodynamics) registry undergoing mechanical thrombectomy with the FlowTriever System (Inari Medical) were included. The prevalence of normotensive shock (systolic blood pressure ≥90 mm Hg but cardiac index ≤2.2 L/min/m2) was assessed. A composite shock score consisting of markers of right ventricular function and ischemia (elevated troponin, elevated B-type natriuretic peptide, moderately/severely reduced right ventricular function), central thrombus burden (saddle PE), potential additional embolization (concomitant deep vein thrombosis), and cardiovascular compensation (tachycardia) was prespecified and assessed for its ability to identify normotensive shock patients. RESULTS: Over one-third of intermediate-risk PE patients in FLASH (131/384, 34.1%) were in normotensive shock. The normotensive shock prevalence was 0% in patients with a composite shock score of 0 and 58.3% in those with a score of 6 (highest score). A score of 6 was a significant predictor of normotensive shock (odds ratio: 5.84; 95% CI: 2.00-17.04). Patients showed significant on-table improvements in hemodynamics post-thrombectomy, including normalization of the cardiac index in 30.5% of normotensive shock patients. Right ventricular size, function, dyspnea, and quality of life significantly improved at the 30-day follow-up. CONCLUSIONS: Although hemodynamically stable, over one-third of intermediate-risk FLASH patients were in normotensive shock with a depressed cardiac index. A composite shock score effectively further risk stratified these patients. Mechanical thrombectomy improved hemodynamics and functional outcomes at the 30-day follow-up.

Acute outcomes for the full US cohort of the FLASH mechanical thrombectomy registry in pulmonary embolism.

BACKGROUND: Evidence supporting interventional pulmonary embolism (PE) treatment is needed. AIMS: We aimed to evaluate the acute safety and effectiveness of mechanical thrombectomy for intermediate- and high-risk PE in a large real-world population. METHODS: FLASH is a multicentre, prospective registry enrolling up to 1,000 US and European PE patients treated with mechanical thrombectomy using the FlowTriever System. The primary safety endpoint is a major adverse event composite including device-related death and major bleeding at 48 hours, and intraprocedural adverse events. Acute mortality and 48-hour outcomes are reported. Multivariate regression analysed characteristics associated with pulmonary artery pressure and dyspnoea improvement. RESULTS: Among 800 patients in the full US cohort, 76.7% had intermediate-high risk PE, 7.9% had high-risk PE, and 32.1% had thrombolytic contraindications. Major adverse events occurred in 1.8% of patients. All-cause mortality was 0.3% at 48-hour follow-up and 0.8% at 30-day follow-up, with no device-related deaths. Immediate haemodynamic improvements included a 7.6 mmHg mean drop in mean pulmonary artery pressure (-23.0%; p<0.0001) and a 0.3 L/min/m2 mean increase in cardiac index (18.9%; p<0.0001) in patients with depressed baseline values. Most patients (62.6%) had no overnight intensive care unit stay post-procedure. At 48 hours, the echocardiographic right ventricle/left ventricle ratio decreased from 1.23±0.36 to 0.98±0.31 (p<0.0001 for paired values) and patients with severe dyspnoea decreased from 66.5% to 15.6% (p<0.0001).  Conclusions: Mechanical thrombectomy with the FlowTriever System demonstrates a favourable safety profile, improvements in haemodynamics and functional outcomes, and low 30-day mortality for intermediate- and high-risk PE.

Underutilization of left heart catheterization in kidney transplant patients presenting with non-ST segment elevation myocardial infarction.

Background: Cardiovascular disease (CVD) is the leading cause of mortality in kidney transplant (KT) patients. The perceived risk of contrast-induced nephropathy (CIN) may create a reluctance to perform coronary angiography in patients presenting with non-ST segment elevation myocardial infarction (NSTEMI). Methods: National Inpatient Sample (NIS) Database was used to sample individuals presenting with NSTEMI. Patients were stratified into KT and Non-KT cohorts. Outcomes included left heart catheterization rates, mortality, arrhythmias, acute kidney injury/acute renal failure (AKI/ARF), and extended length of hospital stay (ELOS) (>72 h). Propensity matching (1:1 ratio) and regression analyses were performed. Results: Out of 336,354 patients with NSTEMI, 742 patients were in the KT group. KT patients were less likely to have LHC relative to non-KT patients (22.0 % vs 18.3 %); a difference that persisted on post-match analysis (27.1 % vs 19.4 %). On pre-match analysis, KT transplant patients that underwent LHC had lower mortality (10.3 % vs 0.7 %), AKI/ARF (44.6 % vs 27.9 %), arrhythmias (30.4 % vs 20.6 %) and lower ELOS (58.6 % vs 41.9 %). Post-match, KT cohort patient that underwent LHC had lower arrhythmias (OR:0.60[0.38-0.96]), AKI/ARF (OR = 0.51[0.34-0.77]), ELOS (OR:0.49[0.34-0.73]). Conclusion: KT patients underwent LHC much less frequently than their non-KT counterparts for NSTEMI. Coronary angiography and subsequent revascularization were associated with a significant decrease in morbidity and mortality. This theorized risk of CIN should not outweigh the benefit of LHC in KT patients.

Longer-Term Outcomes Following Mechanical Thrombectomy for Intermediate- and High-Risk Pulmonary Embolism: 6-Month FLASH Registry Results.

Background: Mechanical thrombectomy provides rapid hemodynamic improvements after acute pulmonary embolism (PE), but long-term benefits are uncertain. Methods: FlowTriever All-comer Registry for Patient Safety and Hemodynamics is a prospective, single-arm, multicenter registry of patients with acute PE treated with the FlowTriever System (Inari Medical). Six-month outcomes including modified Medical Research Council dyspnea scores (MMRCD), right ventricular (RV) function, 6-minute walk test distances, and PE quality-of-life scores (QoL) were assessed. Results: In total, 799 patients were enrolled and 75% completed the study with a mean follow-up of 204 ± 46 days. Demographic characteristics included 54.1% men, mean age of 61.2 years, 77.1% intermediate-high-risk PE, and 8.0% high-risk PE. All-cause mortality was 4.6% at study completion. The proportion of patients with normal echocardiographic RV function increased from 15.1% at baseline to 95.1% at 6 months (P < .0001). MMRCD score improved from 3.0 at baseline to 0.0 at 6 months (P < .0001). 6-minute walk test distances increased from 180 m at 48 hours to 398 m at 6 months (P < .001). Median PE QoL total scores were 9.38 at 30 days and 4.85 at 6 months (P < .001). Prevalence of site-reported chronic thromboembolic pulmonary hypertension was 1.0% and chronic thromboembolic disease was 1.9%. Conclusions: In this large diverse group of PE patients, 6-month all-cause mortality, chronic thromboembolic pulmonary hypertension, and chronic thromboembolic disease were low following thrombectomy with the FlowTriever system. Significant improvements in RV function, patient symptoms, exercise capacity, and QoL were observed at 6 months, suggesting that rapid extraction of thrombus may prevent long-term sequelae in patients with PE.

Percutaneous mechanical thrombectomy in a real-world pulmonary embolism population: Interim results of the FLASH registry.

OBJECTIVES: The FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) is a prospective multi-center registry evaluating the safety and effectiveness of percutaneous mechanical thrombectomy for treatment of pulmonary embolism (PE) in a real-world patient population (NCT03761173). This interim analysis reports outcomes for the first 250 patients enrolled in FLASH. BACKGROUND: High- and intermediate-risk PEs are characterized by high mortality rates, frequent readmissions, and long-term sequelae. Mechanical thrombectomy is emerging as a front-line therapy for PE that enables immediate thrombus reduction while avoiding the bleeding risks inherent with thrombolytics. METHODS: The primary endpoint is a composite of major adverse events (MAE) including device-related death, major bleeding, and intraprocedural device- or procedure-related adverse events at 48 h. Secondary endpoints include on-table changes in hemodynamics and longer-term measures including dyspnea, heart rate, and cardiac function. RESULTS: Patients were predominantly intermediate-risk per ESC guidelines (6.8% high-risk, 93.2% intermediate-risk). There were three MAEs (1.2%), all of which were major bleeds that resolved without sequelae, with no device-related injuries, clinical deteriorations, or deaths at 48 h. All-cause mortality was 0.4% at 30 days, with a single death that was unrelated to PE. Significant on-table improvements in hemodynamics were noted, including an average reduction in mean pulmonary artery pressure of 7.1 mmHg (22.2%, p < 0.001). Patient symptoms and cardiac function improved through follow-up. CONCLUSIONS: These interim results provide preliminary evidence of excellent safety in a real-world PE population. Reported outcomes suggest that mechanical thrombectomy can result in immediate hemodynamic improvements, symptom reduction, and cardiac function recovery.

Objective Outcome Measures for Trials in Patients With Chronic Limb-Threatening Ischemia Across 2 Decades: Analysis and Recommendations.

Chronic limb-threatening ischemia (CLTI) is prevalent and associated with morbidity and mortality. The published research concerning CLTI therapeutics is evolving. The goals of this review are to: 1) summarize the endpoints that are being used in trials assessing interventions for patients with CLTI; and 2) review gaps and discrepancies in current outcome definitions. A search was conducted of the PubMed database and ClinicalTrials.gov to identify studies published between January 2000 and March 2020 that evaluated treatment options for patients with CLTI. Meta-analyses, case series, case reports, abstracts, and expert opinion were excluded. Forty-nine studies (n = 11,667) were identified that fulfilled the inclusion criteria. Most trials reported clinical outcomes (mortality, 69.4%; limb events, 87.8%; target lesion revascularization, 83.7%). Mean follow-up duration was 23.7 months. In investigational device exemption trials, total follow-up and follow-up to primary outcomes were discordant (12 months vs 6 months; P = 0.0018). Hemodynamic testing was reported in 71.4%, usually ankle-brachial index. Patency was assessed in 89.8% of trials; ultrasound was used in 65.3% and invasive angiography in 85.7%, at baseline and/or during follow-up. Wound assessment was performed in 49.0% of studies, qualitative in 28.6% and quantitative in 20.4%. Finally, quality of life assessment was performed in 55% of studies. Definitions for many outcomes varied across studies. Consensus regarding which outcomes to study, uniform definitions, and optimal methods to measure some of these outcomes are yet to be established. A comprehensive effort by all stakeholders is needed to move the field of CLTI forward.

Current interventional therapies in acute pulmonary embolism.

Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality. The management of PE is currently evolving given the development of new technologies and team-based approaches. This document will focus on risk stratification of PEs, review of the current interventional therapies, the role of clinical endpoints to assess the effectiveness of different interventional therapies, and the role for mechanical circulatory support in the complex management of this disease.

Health Care Utilization Following Inpatient Femoropopliteal Revascularization With Drug-Coated Balloon Angioplasty: A Nationwide Cohort Analysis.

PURPOSE: To examine nationwide variations in inpatient use of drug-coated balloons (DCBs) for treating femoropopliteal segment occlusive disease and whether DCBs are associated with reduced early out-of-hospital health care utilization. MATERIALS AND METHODS: The study included 24,022 patients who survived hospitalization for femoropopliteal revascularization using DCB angioplasty (n=7850) or uncoated balloon angioplasty (n=16,172) in the 2016-2017 Nationwide Readmissions Database. Differences in patient, hospitalization, and institutional characteristics were compared between treatment strategies. Adjusted logistic regression models were used to examine differences in 6-month rates of readmission, amputation, and repeat intervention. Results are presented as the odds ratio (OR) and 95% confidence interval (CI). RESULTS: Patients treated with DCBs had a higher prevalence of chronic limb-threatening ischemia, diabetes, hypertension, and tobacco use. Revascularization with a DCB was associated with shorter hospitalizations, lower median hospitalization costs, and fewer inpatient lower extremity amputations. Readmissions at 6 months were decreased in patients treated with DCBs compared with uncoated balloon angioplasty (OR 0.90, 95% CI 0.83 to 0.98, p=0.014). The most common reasons for readmission were complications related to procedures (15.4%) and diabetes (15.4%). Compared to patients treated with DCBs, patients treated with uncoated balloon angioplasty were more often readmitted with early procedure-related complications (13.3% vs 17.5%). There were no between-group differences in readmission for sepsis, myocardial infarction, or congestive heart failure. CONCLUSION: DCBs are less often used compared to uncoated balloons during inpatient femoropopliteal procedures. While DCB utilization is associated with more severe comorbidities and advanced peripheral artery disease, readmission rates are decreased through the first 6 months.

Pulmonary Embolism in Patients Hospitalized With COVID-19 (From a New York Health System).

Pulmonary embolisms (PEs) in coronavirus disease 2019 (COVID-19) have increasingly been reported in observational studies. However, limited information describing their clinical characteristics and outcomes exists. Our study aims to describe clinical features and risk stratification strategies of hospitalized COVID-19 patients with PE. We retrospectively analyzed 101 hospitalized patients with COVID-19 infection and acute PE. Clinical outcomes measured were intensive care unit admission, mechanical ventilation, bleeding and transfusion events, acute kidney injury (AKI) and mortality. Pulmonary severity index (PESI) scores were used for risk stratification. The most common comorbidities were hypertension (50%), obesity (27%) and hyperlipidemia (32%) among this cohort. Baseline D-dimer abnormalities (4,647.0 ± 8,281.8) were noted on admission with a 3-fold increase at the time of PE diagnosis (13,288.4 ± 14,917.9; p <0.05). Five (5%) patients required systemic thrombolysis and 12 (12%) patients experienced moderate to severe bleeding. Thirty-one (31%) patients developed AKI and 1 (1%) patient required renal replacement therapy. Twenty-three (23%) patients were admitted to intensive care unit, of which 20 (20%) patients received mechanical ventilation. The mortality rate was 20%. Most patients (65%) had Intermediate to high risk PESI scores (>85), which portended a worse prognosis with higher mortality rate and length of stay. In conclusion, this study provides characteristics and early outcomes for hospitalized patients with COVID-19 and acute pulmonary embolism. PESI scores were utilized for risk stratifying clinical outcomes. Our results should serve to alert the medical community to heighted vigilance of this VTE complication associated with COVID-19 infection.