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Left atrial veno-arterial extracorporeal membrane oxygenation (LAVA-ECMO) in CS is a novel mechanical cardiocirculatory support strategy that provides robust cardiocirculatory support and simultaneous left and right atrial venting via a multi-fenestrated transeptal catheter. We performed a single-center retrospective analysis of all patients aged ≥ 18 years with CS who underwent LAVA-ECMO at a quaternary care institution from 2018-2023. Clinical outcomes as well as pre- and post-hemodynamics were evaluated. A total of 68 patients were analyzed (75% male, 72% white, median age 63). Indications for LAVA-ECMO were CS due to myocardial infarction (29.4%), biventricular failure (26.5%), and/or valvular heart disease (26.5%). Trans-septal puncture was guided by intracardiac echocardiography (86.8%) or transesophageal echocardiography (13.2%). Arterial cannulation was performed via transcaval access in 25% of the cases. Post-LAVA-ECMO cannulation was associated with substantial improvement in the hemodynamics within 24 hours post cannulation, including reduction in right atrial pressure (absolute mean difference: -5.0 mmHg, p<0.001), mean pulmonary artery pressure (-9.0 mmHg, p<0.001), pulmonary capillary wedge pressure (-10.0 mmHg, p<0.001), and LV end-diastolic pressure (-14.0 mmHg, p<0.001). Survival to decannulation occurred in 69.1%, while 30-day survival from cannulation was 51.5%. In-hospital all-cause mortality was 51.5%. Only 5 patients (7.4%) required additional MCS (4 Impella, 1 VAV-ECMO). There were no complications related to transeptal placement of the venous ECMO cannula. In conclusion, LAVA-ECMO, a MCS strategy providing bi-atrial drainage, appears to also provide simultaneous LV venting as demonstrated by improved invasive hemodynamics. Although the procedure itself appears safe, with no direct complications to interatrial septal cannulation, post-cannulation complications remain high, and further studies are needed to evaluate the full safety profile of LAVA-ECMO compared to alternative MCS strategies., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Inc.)

Background: Transfemoral (TF) access is the preferred approach for transcatheter aortic valve replacement (TAVR). Limited data exist regarding the outcomes of intravascular lithotripsy (IVL)-assisted TF TAVR in patients with peripheral artery disease., Objectives: This study sought to examine contemporary characteristics, trends, and outcomes of IVL TAVR in the United States., Methods: The Vizient Clinical Database was queried for patients who underwent percutaneous TAVR between October 1, 2020, and November 30, 2023. Outcomes with IVL TAVR vs non-IVL TAVR were examined after propensity score matching. The primary outcome was a composite of in-hospital death, stroke, vascular complications, surgical vascular intervention, and major bleeding., Results: Over the study period, 129,655 patients (mean age of 78.4 years, 42.2% women, 87.1% White) underwent percutaneous TAVR at 361 hospitals, 1,242 (0.96%) of whom underwent IVL TAVR. There was an uptrend in IVL TAVR, but the frequency remained low. IVL TAVR patients had a higher median Elixhauser comorbidity score (5 [Q1-Q3: 4-7] vs 4 [Q1-Q3: 3-6]) compared to non-IVL TAVR. TAVR was completed via the TF approach in 1,238 (99.7%) IVL TAVR patients. In a 3:1 propensity score matching analysis, IVL TAVR was associated with a higher rate of the primary composite outcome (21.9% vs 13.7%; P < 0.001) driven by higher rates of vascular complications, surgical vascular intervention, and major bleeding. In-hospital death and stroke were similar in both groups., Conclusions: In the United States, IVL is increasingly adopted to facilitate TF TAVR. IVL TAVR patients exhibited a higher burden of comorbidities and experienced more complications compared to non-IVL TAVR patients. Further studies are needed to identify appropriate anatomical and clinical use criteria for IVL TAVR and to compare its outcomes vs alternative non-TF TAVR., Competing Interests: Funding Support and Author Disclosures Dr Soukas has received institutional research grants from Shockwave Medical. Dr Abbott has received personal fees for consulting from Abbott, Medtronic, and Penumbra Inc; and has received institutional research grants from Boston Scientific, Recor Medical, Med Alliance, and Shockwave Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Context: Patients with adrenal insufficiency (AI) have both increased risk of cardiovascular disease and adverse outcomes with many medical emergencies. However, limited data exist specifically regarding ST-segment elevation myocardial infarction (STEMI) in the context of AI., Objective: To evaluate associations between AI and in-hospital outcomes of patients with STEMI., Methods: Admissions for STEMI were identified in the 2016-2019 National Inpatient Sample. In-hospital outcomes were compared between patients with and without AI. The primary outcome was in-hospital mortality. Secondary outcomes included percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), intervention, acute kidney injury (AKI), vasopressor use, mechanical circulatory support (MCS), mechanical ventilation, ventricular tachycardia (VT), hospital length of stay (LOS), and total charges. Multivariable regression models were used to adjust for potential confounders., Results: Among 690 430 STEMI hospitalizations, 1382 (0.2%) had a diagnosis of AI. AI was associated with higher odds of in-hospital mortality (adjusted OR [aOR] 1.51, 95% CI 1.03-2.2), lower odds of PCI (aOR 0.73, 95% CI 0.55-0.98), higher odds of CABG (aOR 2.8, 95% CI 1.89-4.2) and, AKI (aOR 2.38, 95% CI 1.72-3.3), VT (aOR 1.55, 95% CI 1.1-2.2), need for vasopressors (aOR 2.34, 95% CI 1.33-4.1), mechanical ventilation (aOR 2.11, 95% CI 1.54-2.89), and MCS (aOR 2.18, 95% CI 1.57-3.03). Patients with AI also had a longer LOS (10 days vs 4.2 days, P < .001) and higher charges ($258 475 vs $115 505, P < .001)., Conclusion: Patients with AI admitted for STEMI had higher in-hospital mortality, nonfatal adverse outcomes, and resource utilization than patients without AI., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Endocrine Society.)

Recent reports have revealed a substantial morbidity burden associated with "post-PE syndrome" (PPES). Cardiopulmonary exercise testing (CPET) has shown promise in better characterizing these patients. In this systematic review and pooled analysis, we aim to use CPET data from PE survivors to understand PPES better. A literature search was conducted in PubMed, EMBASE, and Cochrane for studies reporting CPET results in post-PE patients without known pulmonary hypertension published before August 1, 2023. Studies were independently reviewed by two authors. CPET findings were subcategorized into (1) exercise capacity (percent predicted pVO 2 and pVO 2 ) and (2) ventilatory efficiency (VE/VCO 2 slope and V D /V T ). We identified 14 studies ( n  = 804), 9 prospective observational studies, 4 prospective case-control studies, and 1 randomized trial. Pooled analysis demonstrated a weighted mean percent predicted pVO 2 of 76.09 ± 20.21% ( n  = 184), with no difference between patients tested <6 months ( n  = 76, 81.69±26.06%) compared to ≥6 months post-acute PE ( n  = 88, 82.55 ± 21.47%; p  = 0.817). No difference was seen in pVO 2 in those tested <6 months ( n  = 76, 1.67 ± 0.51 L/min) compared to ≥6 months post-acute PE occurrence ( n  = 144, 1.75 ± 0.57 L/min; p  = 0.306). The weighted mean VE/VCO 2 slope was 32.72 ± 6.02 ( n  = 244), with a significant difference noted between those tested <6 months ( n  = 91, 36.52 ± 6.64) compared to ≥6 months post-acute PE ( n  = 191, 31.99 ± 5.7; p  < 0.001). In conclusion, this study, which was limited by small sample sizes and few multicenter studies, found no significant difference in exercise capacity between individuals tested <6 months versus ≥6 months after acute PE. However, ventilatory efficiency was significantly improved in patients undergoing CPET ≥ 6 months compared to those <6 months from the index PE., Competing Interests: The authors declare no conflicts of interest., (© 2024 The Author(s). Pulmonary Circulation published by John Wiley & Sons Ltd on behalf of Pulmonary Vascular Research Institute.)

Competing Interests: Declaration of conflicting interestsDr Mena-Hurtado receives research funding from Shockwave, Abbott, and Merck and is a consultant for Cook and Terumo. Dr Aronow is a consultant for Philips, ReCor Medical, and Silk Road Medical. Dr Bikdeli is supported by a Career Development Award from the American Heart Association and VIVA Physicians (#938814), Scott Schoen and Nancy Adams IGNITE Award, Mary Ann Tynan Research Scientist Award from the Mary Horrigan Connors Center for Women’s Health and Gender Biology at Brigham and Women’s Hospital, and the Heart and Vascular Center Junior Faculty Award from Brigham and Women’s Hospital. Dr Bikdeli serves on the Medical Advisory Board for the North American Thrombosis Forum and the Data Safety and Monitory Board of the NAIL-IT trial funded by the National Heart, Lung, and Blood Institute, and Translational Sciences, and is collaborating consultant with the International Consulting Associates and US Food and Drug Administration. The remaining authors have no relevant conflicts of interest.

Competing Interests: Declaration of competing interest Dr. Goldsweig reports speaking for Philips, Edwards Lifesciences, and Conformal Medical and consulting for Philips and Inari Medical. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Background: Despite optimal medical therapy, a significant proportion of patients' blood pressure remains uncontrolled. Catheter-based renal denervation (RDN) has been proposed as a potential intervention for uncontrolled hypertension. We conducted an updated meta-analysis to assess the efficacy and safety of RDN in patients with uncontrolled hypertension, with emphasis on the differential effect of RDN in patients on and off antihypertensive medications., Methods and Results: Online databases were searched to identify randomized clinical trials comparing efficacy and safety of RDN versus control in patients with uncontrolled hypertension. Subgroup analyses were conducted for sham-controlled trials and studies that used RDN devices that have gained or are currently seeking US Food and Drug Administration approval. Fifteen trials with 2581 patients (RDN, 1723; sham, 858) were included. In patients off antihypertensive medications undergoing RDN, a significant reduction in 24-hour ambulatory (-3.70 [95% CI, -5.41 to -2.00] mm Hg), office (-4.76 [95% CI, -7.57 to -1.94] mm Hg), and home (-3.28 [95% CI, -5.96 to -0.61] mm Hg) systolic blood pressures was noted. In patients on antihypertensive medications, a significant reduction was observed in 24-hour ambulatory (-2.23 [95% CI, -3.56 to -0.90] mm Hg), office (-6.39 [95% CI, -11.49 to -1.30]), home (-6.08 [95% CI, -11.54 to -0.61] mm Hg), daytime (-2.62 [95% CI, -4.14 to -1.11]), and nighttime (-2.70 [95% CI, -5.13 to -0.27]) systolic blood pressures, as well as 24-hour ambulatory (-1.16 [95% CI, -1.96 to -0.35]), office (-3.17 [95% CI, -5.54 to -0.80]), and daytime (-1.47 [95% CI, -2.50 to -0.27]) diastolic blood pressures., Conclusions: RDN significantly lowers blood pressure in patients with uncontrolled hypertension, in patients off and on antihypertensive medications, with a favorable safety profile. The efficacy of RDN was consistent in sham-controlled trials and contemporary trials using US Food and Drug Administration-approved devices.

Background: While transcatheter aortic valve replacement (TAVR) has broadened treatment options for critically ill patients, outcomes among those with concomitant cardiogenic shock (CS) are not well-explored., Methods: We conducted a comprehensive search of major databases for studies comparing outcomes following TAVR in patients with and without CS since inception up to October 31, 2023. Our meta-analysis included five non-randomized observational. Dichotomous outcomes were assessed using the Mantel-Haenszel method (risk ratio, 95 % CI), and continuous outcomes were evaluated using mean difference and 95 % CI with the inverse variance method. Statistical heterogeneity was determined using the inconsistency test (I 2 )., Results: Among 26,283 patients across five studies, 30-day mortality was higher in the CS group (7267 patients; 27.6 %) compared to those without CS (OR 3.41, 95 % CI [2.01, 5.76], p < 0.01), as well as 30-day major vascular complications (OR 1.72, 95 % CI [1.54, 1.92], p < 0.01). At 1-year follow-up, there was no statistically significant difference in mortality rates between the compared groups (OR 2.68, 95 % CI [0.53, 13.46], p = 0.12). No significant between-group differences were observed in the likelihood of 30-day aortic valve reintervention (OR 3.20, 95 % CI [0.63, 16.22], p = 0.09) or post-TAVR aortic insufficiency (OR 0.91, 95 % CI [0.33, 2.51], p = 0.73). Furthermore, 30-day stroke, pacemaker implantation, and in-hospital major bleeding were comparable between both cohorts., Conclusion: Among patients undergoing TAVR, short-term mortality is higher but one-year outcomes are similar when comparing those with, to those without, CS. Future studies should examine whether TAVR outcomes are improved when the procedure is delayed to optimize CS and when delay is not possible, whether particular management strategies lead to more favorable periprocedural outcomes., Competing Interests: Declaration of competing interest The authors have no competing interests to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Aim: The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia)., Methods: A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate., Structure: Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed., (Copyright © 2024 American College of Cardiology Foundation and the American Heart Association, Inc. Published by Elsevier. Published by Elsevier Inc. All rights reserved.)

Aim: The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia)., Methods: A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate., Structure: Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed.

Objectives: Cardiovascular risk factors and history of cardiovascular disease are associated with greater morbidity and mortality in patients hospitalized with COVID-19. Limited English proficiency (LEP) has also been associated with worse outcomes in this setting, including requiring intensive care unit (ICU) level of care and in-hospital death. Whether non-English-language preference (NELP) modifies the association between cardiovascular risk factors or disease and outcomes in patients hospitalized with COVID-19 is unknown., Study Design: Retrospective cohort study of adult patients admitted to a large New England health system between March 1 and December 31, 2020, who tested positive for COVID-19. NELP was defined as having a preferred language that was not English noted in the electronic health record., Methods: Cardiovascular risk factors, history of cardiovascular disease, and NELP were related to the primary composite clinical outcome-death or ICU admission-using multivariable binary logistic regression adjusted for demographic and clinical characteristics. Interaction terms for NELP and model covariates were evaluated., Results: Of 3582 patients hospitalized with COVID-19, 1024 (28.6%) had NELP; 812 (79.3%) of the patients with NELP received interpreter services. Death or ICU admission occurred in 794 (22.2%) of the hospitalized patients. NELP was not significantly associated with the primary composite outcome in unadjusted or adjusted analyses. In the adjusted analyses, only male gender, coronary artery disease, pulmonary circulatory disease, and liver disease significantly predicted the primary outcome. NELP did not modify the effect of these associations., Conclusions: NELP was not significantly associated with odds of death or ICU admission, nor did it modify the association between cardiovascular risk factors or history of cardiovascular disease and this composite outcome. Because most patients with NELP received interpreter services, these findings may support the role of such services in ensuring equitable outcomes.

Pulmonary embolism (PE) is a common acute cardiovascular condition. Within this review, we discuss the incidence, pathophysiology, and treatment options for patients with high-risk and massive pulmonary embolisms. In particular, we focus on the role of mechanical circulatory support devices and their possible therapeutic benefits in patients who are unresponsive to standard therapeutic options. Moreover, attention is given to device selection criteria, weaning protocols, and complication mitigation strategies. Finally, we underscore the necessity for more comprehensive studies to corroborate the benefits and safety of MCS devices in PE management.

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., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Timely revascularization is essential for limb salvage and to reduce mortality in patients with chronic limb-threatening ischemia (CLTI). In patients who are candidates for endovascular therapy and surgical bypass, the optimal revascularization strategy remains uncertain. Recently published randomized controlled trials (RCTs) have presented conflicting results. We conducted a trial-level meta-analysis to compare the outcomes between endovascular-first and surgery-first strategies for revascularization. PubMed, Web of Science, and the Cochrane Library were searched to identify RCTs comparing the outcomes of endovascular-first versus surgery-first strategies for revascularization in patients with CLTI. Data were pooled for major outcomes and their aggregate risk ratios (RRs) with 95% confidence intervals were calculated using a random-effects model. Kaplan-Meier curves for amputation-free survival and overall survival time were plotted using the pooled aggregated data from published curves, with their corresponding hazard ratios (HRs) and 95% confidence intervals reported for up to 5 years of follow-up. A total of 3 RCTs with 2,627 patients (1,312 endovascular-first and 1,315 surgery-first) were included in the meta-analysis. Of these, 1,864 patients (70.9%) were men and 347 (13.2%) were older than 80 years. Comparing the endovascular-first and surgery-first approaches, there was no significant difference in the overall (HR 0.92 [0.83 to 1.01], p = 0.09) or amputation-free survival (HR 0.98 [0.92 to 1.03], p = 0.42), reintervention (RR 1.24 [0.74 to 2.07], p = 0.41), major amputation, (RR 1.16 [0.87 to 1.54], p = 0.31), or therapeutic crossover (RR 0.92 [0.37 to 2.26], p = 0.85). In conclusion, data from available RCTs suggest that there is no difference in clinical outcomes between endovascular-first and surgery-first revascularization strategies for CLTI. A planned patient-level meta-analysis may provide further insight., Competing Interests: Declaration of competing interest Dr. Aronow reports serving on the Advisory Board for Medtronic and providing consultancy services for Philips. Dr. Goodney is a committee member contributing to the forthcoming patient-level meta-analysis of BEST-CLI and BASIL-2. The remaining authors have no competing interest to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Little is known about treatment variability across US hospitals for patients with chronic limb-threatening ischemia (CLTI)., Methods and Results: Data were collected from the 2016 to 2018 National Inpatient Sample. All patients aged ≥18 years, admitted to nonfederal US hospitals with a primary diagnosis of CLTI, were identified. Patients were classified according to their clinical presentation (rest pain, skin ulceration, or gangrene) and were further characterized according to the treatment strategy used. The primary outcome of interest was variability in CLTI treatment, as characterized by the median odds ratio. The median odds ratio is defined as the likelihood that 2 similar patients would be treated with a given modality at 1 versus another randomly selected hospital. There were 15 896 (weighted n=79 480) hospitalizations identified where CLTI was the primary diagnosis. Medical therapy alone, endovascular revascularization ± amputation, surgical revascularization ± amputation, and amputation alone were used in 4057 (25%), 5390 (34%), 3733 (24%), and 2716 (17%) patients, respectively. After adjusting for both patient- and hospital-related factors, the median odds ratio (95% CI) for medical therapy alone, endovascular revascularization ± amputation, surgical revascularization ± amputation, any revascularization, and amputation alone were 1.28 (1.19-1.38), 1.86 (1.77-1.95), 1.65 (1.55-1.74), 1.37 (1.28-1.45), and 1.42 (1.27-1.55), respectively., Conclusions: Significant variability in CLTI treatment exists across US hospitals and is not fully explained by patient or hospital characteristics.

Percutaneous revascularization is the primary strategy for treating lower extremity venous and arterial disease. Angiography is limited by its ability to accurately size vessels, precisely determine the degree of stenosis and length of lesions, characterize lesion morphology, or correctly diagnose postintervention complications. These limitations are overcome with use of intravascular ultrasound (IVUS). IVUS has demonstrated the ability to improve outcomes following percutaneous coronary intervention, and there is increasing evidence to support its benefits in the setting of peripheral vascular intervention. At this stage in its evolution, there remains a need to standardize the use and approach to peripheral vascular IVUS imaging. This manuscript represents considerations and consensus perspectives that emerged from a roundtable discussion including 15 physicians with expertise in interventional cardiology, interventional radiology, and vascular surgery, representing 6 cardiovascular specialty societies, held on February 3, 2023. The roundtable's aims were to assess the current state of lower extremity revascularization, identify knowledge gaps and need for evidence, and determine how IVUS can improve care and outcomes for patients with peripheral arterial and deep venous pathology., (© 2024 Society for Cardiovascular Angiography and Interventions Foundation, Society for Vascular Surgery and Society of Interventional Radiology.)

Background: Following regulatory approval, medical devices may be used "off-label." Patent foramen ovale (PFO) closure is indicated to reduce recurrent stroke but has been proposed for other indications, including migraine, transient ischemic attack, and diving decompression illness. We sought to evaluate PFO closure rates and indications relative to the timing of regulatory approval and publication of key randomized trials., Methods: We performed a retrospective cohort study using the OptumLabs Data Warehouse of US commercial insurance enrollees from 2006 to 2019. We quantified PFO closure among individuals with ≥2 years of preprocedure coverage to establish indications, classified hierarchically as stroke/systemic embolism, migraine, transient ischemia attack, or other., Results: We identified 5315 patients undergoing PFO closure (51.8% female, 29.2%≥60 years old), which increased from 4.75 per 100 000 person-years in 2006 to 6.60 per 100 000 person-years in 2019. Patients aged ≥60 years accounted for 29.2% of closures. Procedure volumes corresponded weakly with supportive clinical publications and device approval. Among patients with PFO closure, 58.6% underwent closure for stroke/systemic embolism, 10.2% for transient ischemia attack, 8.8% for migraine, and 22.4% for other indications; 17.6% of patients had atrial fibrillation at baseline; and 11.9% developed atrial fibrillation postprocedure. Those aged ≥60 years and male were less likely to undergo closure for migraine than stroke/systemic embolism., Conclusions: From 2006 to 2019, PFO closure use was consistently low and corresponded weakly with clinical trial publications and regulatory status. Nearly half of patients underwent PFO closure for indications unapproved by the Food and Drug Administration. Regulators and payers should coordinate mechanisms to promote utilization for approved indications to ensure patient safety and should facilitate clinical trials for other possible indications., Competing Interests: Disclosures Dr Goldsweig reports consulting income from Inari Medical and Philips, speaking fees from Philips and Edwards, and research support from the National Institute of General Medical Sciences, 1U54GM115458, and the UNMC Center for Heart and Vascular Research. Dr Cohen reports institutional research grants and personal consulting income from Boston Scientific, Abbott, Medtronic, and Edwards LifeSciences. Dr Ross currently receives research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) Program (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH; R01HS025164, R01HL144644), and from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International; in addition, Dr Ross is an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. The content is solely the responsibility of the authors and does not necessarily represent the official views of their employers or research supporters. The other authors report no conflicts.

Background: Little to no data exist to guide treatment decision in patients with venous thromboembolism (VTE) and chronic liver disease., Objectives: To assess the effectiveness and safety of direct oral anticoagulants (DOACs)-individually and as a class-vs warfarin and between 2 DOACs in patients with acute VTE and chronic liver disease., Methods: We conducted a retrospective, US claims-based, propensity score-matched cohort study in adults with acute VTE and chronic liver disease who had newly initiated oral anticoagulants between 2011 and 2017. The primary outcome was a composite of hospitalization for recurrent VTE and hospitalization for major bleeding., Results: The cohorts included 2361 DOAC-warfarin, 895 apixaban-warfarin, 2161 rivaroxaban-warfarin, and 895 apixaban-rivaroxaban matched pairs. Lower risk of the primary outcome was seen with DOACs (hazard ratio [HR], 0.72; 95% CI, 0.61-0.85), apixaban (HR, 0.48; 95% CI, 0.35-0.66) or rivaroxaban (HR, 0.73; 95% CI, 0.61-0.88) vs warfarin but not apixaban-rivaroxaban (HR, 0.68; 95% CI, 0.43-1.08). The HRs of hospitalization for major bleeding were 0.69 (95% CI, 0.57-0.84) for DOAC-warfarin, 0.43 (95% CI, 0.30-0.63) for apixaban-warfarin, 0.72 (95% CI, 0.58-0.89) for rivaroxaban-warfarin, and 0.60 (95% CI, 0.35-1.06) for apixaban-rivaroxaban. Recurrent VTE risk was lower with apixaban (HR, 0.47; 95% CI, 0.26-0.86), but not DOACs (HR, 0.81; 95% CI, 0.59-1.12) or rivaroxaban vs warfarin (HR, 0.81; 95% CI, 0.57-1.14) or apixaban-rivaroxaban (HR, 0.92; 95% CI, 0.42-2.02)., Conclusion: While the magnitude of clinical benefit varied across individual DOACs, in adults with acute VTE and chronic liver disease, oral factor Xa inhibitors (as a class or individually) were associated with lower risk of recurrent VTE and major bleeding., (© 2023 The Authors.)

COVID-19 is associated with endothelial activation in the setting of a potent inflammatory reaction and a hypercoagulable state. The end result of this thromboinflammatory state is an excess in thrombotic events, in particular venous thromboembolism. Pulmonary embolism (PE) has been of special interest in patients with COVID-19 given its association with respiratory deterioration, increased risk of intensive care unit admission, and prolonged hospital stay. The pathophysiology and clinical characteristics of COVID-19-associated PE may differ from the conventional non-COVID-19-associated PE. In addition to embolic events from deep vein thrombi, in situ pulmonary thrombosis, particularly in smaller vascular beds, may be relevant in patients with COVID-19. Appropriate prevention of thrombotic events in COVID-19 has therefore become of critical interest. Several changes in viral biology, vaccination, and treatment management during the pandemic may have resulted in changes in incidence trends. This review provides an overview of the pathophysiology, epidemiology, clinical characteristics, and risk factors of COVID-19-associated PE. Furthermore, we briefly summarize the results from randomized controlled trials of preventive antithrombotic therapies in COVID-19, focusing on their findings related to PE. We discuss the acute treatment of COVID-19-associated PE, which is substantially similar to the management of conventional non-COVID-19 PE. Ultimately, we comment on the current knowledge gaps in the evidence and the future directions in the treatment and follow-up of COVID-19-associated PE, including long-term management, and its possible association with long-COVID., Competing Interests: L.O-P: Nothing to disclose.A.H.T.: Nothing to disclose.P.S.: Nothing to disclose.T.S.P.: Nothing to disclose.H.D.A.: Outside the submitted work, H.A.D. is a consultant for Silk Road Medical for Philips.L.J-P.: Grants from Leo Pharma and MSD and personal fees from Daichii, Rovi, GlaxoSmithKline, and Actellion outside the submitted work.M.S.: Co-principal investigator of the RAPID trial.D.J.A.: Consulting fees or honoraria from Abbott, Amgen, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Daiichi-Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, PhaseBio, PLx Pharma, Pfizer, and Sanofi. D.J.A. also declares that his institution has received research grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Idorsia, Janssen, Matsutani Chemical Industry Co., Merck, Novartis, Osprey Medical, Renal Guard Solutions, and the Scott R. MacKenzie Foundation.G.Y.H.L.: Consultant and speaker for BMS/Pfizer, Boehringer Ingelheim, and Daiichi-Sankyo. No fees are received personally.B.B.: Reports that he is a consulting expert, on behalf of the plaintiff, for litigation related to two specific brand models of IVC filters., (Thieme. All rights reserved.)

Patients who underwent transcatheter aortic valve implantation (TAVI) with concomitant atrial fibrillation (AF) are at a higher risk for thromboembolic and bleeding events. The optimal antithrombotic strategy for patients with AF after TAVI remains unclear. We sought to determine the comparative efficacy and safety of direct oral anticoagulants (DOAC) versus oral vitamin K antagonists (VKAs) in these patients. Electronic databases such as PubMed, Cochrane, and Embase databases were searched till January 31, 2023, for relevant studies evaluating clinical outcomes of VKA versus DOAC in patients with AF after TAVI. Outcomes assessed were (1) all-cause mortality, (2) stroke, (3) major/life-threatening bleeding, and (4) any bleeding. Hazard ratios (HRs) were pooled in meta-analysis using random effect model. Nine studies (2 randomized and 7 observational) were included in systematic review, and 8 studies with 25,769 patients were eligible to be included in the meta-analysis. The mean age of the patients was 82.1 years, and 48.3% were male. Pooled analysis using random-effects model showed no statistically significant difference in all-cause mortality (HR 0.91, 95% confidence interval [CI] 0.76 to 1.10, p = 0.33), stroke (HR 0.96, 95% CI 0.80 to 1.16, p = 0.70), and major/life-threatening bleeding (HR 1.05, 95% CI 0.82 to 1.35, p = 0.70) in patients that received DOAC compared with oral VKA. Risk of any bleeding was lower in the DOAC group compared with oral VKA (HR 0.83, 95% CI 0.76 to 0.91, p = 0.0001). In patients with AF, DOACs appear to be a safe alternative oral anticoagulation strategy to oral VKA after TAVI. Further randomized studies are required to confirm the role of DOACs in those patients., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: In patients with intermittent claudication (IC), short-term amputation rates from clinical trial data following lower extremity femoropopliteal (FP) peripheral vascular intervention (PVI) are <1% with unknown longer-term rates., Objectives: The aim of this study was to identify revascularization and amputation rates following PVI in the FP segment and to assess 4-year amputation and revascularization rates after FP PVI for IC., Methods: From 2016 to 2020, 19,324 patients undergoing FP PVI for IC were included from the PINC AI Healthcare Database and evaluated by treatment level (superficial femoral artery [SFA], popliteal artery [POP], or both). The primary outcome was index limb amputation (ILA) assessed by Kaplan-Meier estimate. The secondary outcomes were index limb major amputation and repeat revascularization. HRs were estimated using Cox proportional hazard regression., Results: The 4-year index limb amputation rate following FP PVI was 4.3% (95% CI: 4.0-4.7), with a major amputation rate of 3.2% (95% CI: 2.9-3.5). After POP PVI, ILA was significantly higher than SFA alone (7.5% vs 3.4%) or both segment PVI (5.5%). In multivariate analysis, POP PVI was associated with higher ILA rates at 4 years compared with isolated SFA PVI (HR: 2.10; 95% CI: 1.52-2.91) and index limb major amputation (HR: 1.98; 95% CI: 1.32-2.95). Repeat FP revascularization rates were 15.2%; they were highest in patients undergoing both SFA and POP PVI (18.7%; P < 0.0001) compared with SFA (13.9%) and POP (17.1%) only., Conclusions: IC patients undergoing FP PVI had 4-year rates of index limb repeat revascularization of 16.7% and ILA rates of 4.3%. Further risk factors for amputation requires further investigation., Competing Interests: Funding Support and Author Disclosures Dr Hess has received research funding to Colorado Prevention Center Clinical Research from Merck, Bayer, and Amgen. Dr Curtis has a contract with the American College of Cardiology for his role as senior medical officer of the National Cardiovascular Data Registry; has received salary support from the American College of Cardiology, National Cardiovascular Data Registry; and holds equity interest in Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Cardiovascular complications contribute to 40% of coronavirus disease 2019 (COVID-19) related deaths. The viral myocarditis associated with COVID-19 accounts for significant morbidity and mortality. How COVID-19 myocarditis compares to other viral myocardites is unknown., Methods: The authors conducted a retrospective cohort study using the National Inpatient Sample database to identify adult patients hospitalized for viral myocarditis in 2020 and to compare outcomes between those with and without COVID-19. The primary study outcome was in-hospital mortality. Secondary outcomes included in-hospital complications, length of stay, and total costs., Results: The study population included 15 390 patients with viral myocarditis, of whom 5540 (36%) had COVID-19. After adjustment for baseline characteristics, patients with COVID-19 had higher odds of in-hospital mortality [adjusted odds ratio (aOR) 3.46, 95% CI 2.57-4.67], cardiovascular complications (aOR 1.46, 95% CI 1.14-1.87) including cardiac arrest (aOR 2.07, 95% CI 1.36-3.14), myocardial infarction (aOR 2.97, 95% CI 2.10-4.20), venous thromboembolism (aOR 2.01, 95% CI 1.25-3.22), neurologic complications (aOR 1.82, 95% CI 1.10-2.84), renal complications (aOR 1.72, 95% CI 1.38-2.13), and hematologic complications (aOR 1.32, 95% CI 1.10-1.74), but lower odds of acute heart failure (aOR 0.60, 95% CI 0.44-0.80). The odds of pericarditis, pericardial effusion/tamponade, cardiogenic shock, and the need for vasopressors or mechanical circulatory support were similar. Patients with COVID-19 had longer length of stay (7 days vs. 4 days, P <0.01) and higher total costs ($21,308 vs. $14,089, P <0.01)., Conclusions: Among patients with viral myocarditis, COVID-19 is associated with higher in-hospital mortality and cardiovascular, neurologic, renal, and hematologic complications compared to non-COVID-19 viruses., Competing Interests: The authors have no conflict of interest to declare., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

The Coronavirus 2019 (COVID-19) pandemic, caused by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) virus, has resulted in unprecedented morbidity and mortality worldwide. While COVID-19 typically presents as viral pneumonia, cardiovascular manifestations such as acute coronary syndromes, arterial and venous thrombosis, acutely decompensated heart failure (HF), and arrhythmia are frequently observed. Many of these complications are associated with poorer outcomes, including death. Herein we review the relationship between cardiovascular risk factors and outcomes among patients with COVID-19, cardiovascular manifestations of COVID-19, and cardiovascular complications associated with COVID-19 vaccination., Competing Interests: Disclosure The authors have nothing to disclose., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Bleeding events result in morbidity and mortality in patients who underwent percutaneous coronary intervention (PCI). There are limited data on the predicting bleeding complications in patients who underwent stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) and Academic Research Consortium for High Bleeding Risk (ARC-HBR) scores' ability to predict in-hospital outcomes in patients who underwent PCI. Consecutive patients who underwent PCI at tertiary centers from January 2016 to March 2018 were identified and the bleeding risk scores were calculated. The primary end point was the National Cardiovascular Data Registry-defined in-hospital bleeding stratified by low versus high predicted bleeding risk. The major and net adverse cardiovascular events were also examined. The discriminatory ability of the risk models was determined using receiver operating characteristic curves. Among 3,659 patients studied, the in-hospital major bleeding was 3.3% (n = 121). The patients characterized as high bleeding risk by either criterion had significantly higher bleeding rates than those meeting the low-risk criteria (ARC-HBR 5.4% vs 3.3%, p <0.001; PRECISE-DAPT 5.8% vs 2.4%, p <0.001), and higher major adverse cardiovascular events and net adverse clinical events. These risk estimates showed moderate and similar predictive ability (ARC-HBR high-risk area under the receiver operating characteristic curve [AUC] 0.62, PRECISE-DAPT ≥25 AUC 0.61, p = 0.49), with no incremental benefit to adding the estimates (AUC 0.60). The subgroup analysis revealed that women had higher bleeding rates than men (5.53% vs 2.39%, p <0.001); however, the predictive ability of the criteria were similar in women and men. The patients identified as having a high bleeding risk by the PRECISE-DAPT and the ARC-HBR criteria before PCI are at high risk for in-hospital bleeding and adverse outcomes independent of gender. The 2 scores have moderate predictive ability for bleeds. Further study is needed to determine strategies to reduce risk in this population., Competing Interests: Disclosures Dr. Aronow is a consultant for Philips, Silk Road Medical; Dr. Abbott receives research grants form Boston Scientific and MicroPort and is a consultant for Abbott, Medtronic, Philips, and Recor. The remaining authors have no conflicts of interest to declare., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: The benefit-risk profile of direct oral anticoagulants (DOACs) compared with warfarin, and between DOACs in patients with atrial fibrillation (AF) and chronic liver disease is unclear., Methods: We conducted a new-user, retrospective cohort study of patients with AF and chronic liver disease who were enrolled in a large, US-based administrative database between January 1, 2011, and December 31, 2017. We assessed the effectiveness and safety of DOACs (as a class and individually) compared with warfarin, and between DOACs in patients with AF and chronic liver disease. The primary outcomes were hospitalization for ischemic stroke/systemic embolism and hospitalization for major bleeding. Inverse probability treatment weights were used to balance the treatment groups on measured confounders., Results: Overall, 10 209 participants were included, with 4421 (43.2%) on warfarin, 2721 (26.7%) apixaban, 2211 (21.7%) rivaroxaban, and 851 (8.3%) dabigatran. The incidence rates per 100 person-years for ischemic stroke/systemic embolism were 2.2, 1.4, 2.6, and 4.4 for DOACs as a class, apixaban, rivaroxaban, and warfarin, respectively. The incidence rates per 100 person-years for major bleeding were 7.9, 6.5, 9.1, and 15.0 for DOACs as a class, apixaban, rivaroxaban, and warfarin, respectively. After inverse probability treatment weights, the risk of hospitalization for ischemic stroke/systemic embolism was significantly lower between DOACs as a class (hazard ratio [HR], 0.64 [95% CI, 0.46-0.90]) or apixaban (HR, 0.40 [95% CI, 0.19-0.82]) compared with warfarin, but not significantly different between rivaroxaban versus warfarin (HR, 0.76 [95% CI, 0.47-1.21]) or rivaroxaban versus apixaban (HR, 1.73 [95% CI, 0.91-3.29]). Compared with warfarin, the risk of hospitalization for major bleeding was lower with DOACs as a class (HR, 0.69 [95% CI, 0.58-0.82]), apixaban (HR, 0.60 [95% CI, 0.46-0.78]), and rivaroxaban (HR, 0.79 [95% CI, 0.62-1.0]). However, the risk of hospitalization for major bleeding was higher for rivaroxaban versus apixaban (HR, 1.59 [95% CI, 1.18-2.14])., Conclusions: Among patients with AF and chronic liver disease, DOACs as a class were associated with lower risks of hospitalization for ischemic stroke/systemic embolism and major bleeding versus warfarin. However, the incidence of clinical outcomes among patients with AF and chronic liver disease varied between individual DOACs and warfarin, and in head-to-head DOAC comparisons.

Percutaneous balloon mitral valvuloplasty (PBMV) is primarily performed for rheumatic mitral stenosis (MS). Therefore, limited data exist on PBMV in countries with a low incidence of rheumatic disease. Using the Nationwide Readmission Database, we examined trends in in-hospital mortality and 30-day readmission among patients who received PBMV for rheumatic and non-rheumatic MS. We also examined the change in 90-day hospitalization rate before vs after PBMV. Between 2016 and 2019, there were 1109 hospitalizations in which patients received PBMV for rheumatic (n = 955, 86.1%) vs non-rheumatic MS (n = 154, 13.9%). The all-cause in-hospital mortality for rheumatic and non-rheumatic MS did not change over time (0.9% → 2.0%, P = 0.94, and 5.9% → 9.5%, P = 0.09 respectively). Similarly, the 30-day readmission for patients with rheumatic and non-rheumatic MS did not change over time (12.4% → 9.9%, P = 0.26, and 4.4% → 10.5%, P = 0.30, respectively). The 90-day all-cause hospitalization rate remained the same before vs after PBMV for rheumatic and non-rheumatic MS (25.5% → 21.8%; P = 0.14, and 24.0% → 33.7%; P = 0.19, respectively). Although no statistically significant change was noted over time for trends in in-hospital mortality, 30-day readmission, or even in the change in 90-day all-cause hospitalizations before and after PBMV for both types of MS, among those with non-rheumatic MS, there was a signal of an increase in the in-hospital mortality, and 30-day readmission, even more, there was 29% relative increase in 90-day hospitalizations after PBMV. Future studies are needed to examine the role of PBMV in patients with non-rheumatic MS., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Although variation in the management of patients with non-ST-elevation myocardial infarction (NSTEMI) is well documented across US hospitals, few data exist characterizing variation in outcomes following specific management strategies., Methods: Admissions for NSTEMI to hospitals performing coronary angiography, percutaneous coronary intervention (PCI), and coronary artery bypass graft (CABG) surgery between 2016 and 2018 were identified from the National Inpatient Sample. Patients were categorized according to treatment rendered (medical therapy alone, angiography without revascularization, PCI, or CABG). The primary end point was variation in the incidence of composite in-hospital death, postprocedure myocardial infarction, or stroke, stratified by treatment rendered. Secondary outcomes included variation in length of stay (LOS), cost, and use of each treatment modality. Variation was characterized by the median odds ratio., Results: Among 140,194 hospitalizations for NSTEMI, 35,748 (25.5%) patients received medical therapy alone, 28,678 (20.5%) underwent angiography without revascularization, 58,383 (41.6%) underwent PCI, and 17,385 (12.4%) underwent CABG. Despite adjusting for patient- and hospital-related factors, 2 similar patients were 25% more likely to experience the composite primary outcome following PCI and 45% more likely following CABG at 1 randomly selected hospital than at another. Significant hospital-level variations in LOS and cost were also apparent following each treatment modality., Conclusions: In a large national analysis of hospitalizations for NSTEMI, significant variation was observed in clinical outcome, LOS, and cost associated with each treatment modality, despite adjustment for patient- and hospital-related factors., Competing Interests: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© 2022 The Authors.)

Atrial fibrillation/flutter (AF) and COVID-19 are associated with an elevated risk of arterial and venous thrombosis. Whether preadmission oral anticoagulation (OAC) for AF reduces the incidence of in-hospital death or thrombotic events among patients with COVID-19 is unknown. We identified 630 patients with pre-existing AF and a hospitalization diagnosis of COVID-19 and stratified them according to preadmission OAC use. Multivariable logistic regression was employed to relate preadmission OAC to composite in-hospital mortality or thrombotic events. Unadjusted composite in-hospital mortality or thrombotic complications occurred less often in those on than not on preadmission OAC (27.1% vs 46.8%, p <0.001). After adjustment, the incidence of composite in-hospital all-cause mortality or thrombotic complications remained lower with preadmission OAC (odds ratio 0.37, confidence interval 0.25 to 0.53, p <0.0001). Secondary outcomes including all-cause mortality (16.3% vs 24.9%, p = 0.007), intensive care unit admission (14.7% vs 29.0%, p <0.001), intubation (6.4% vs 18.6%, p <0.001), and noninvasive ventilation (18.6% vs 27.5%, p = 0.007) occurred less frequently, and length of stay was shorter (6 vs 7 days, p <0.001) in patients on than those not on preadmission OAC. A higher CHA 2 DS 2 -VASc score was associated with an increased risk of thrombotic events. In conclusion, among patients with baseline AF who were hospitalized with COVID-19, those on preadmission OAC had lower rates of death, arterial and venous thrombotic events, and less severe COVID-19., Competing Interests: Disclosures The authors have no conflicts of interest to declare., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Intravascular lithotripsy (IVL) is a novel endovascular treatment for calcified common femoral artery disease (CFA). Data on midterm effectiveness for clinically driven target lesions revascularization (CD-TLR) is lacking. This study investigated CD-TLR during 18-month follow-up in patients requiring IVL for CFA disease treatment., Methods: In a single-center retrospective cohort study, electronic medical record of patients undergoing IVL for CFA disease from January 2018 to March 2020 were reviewed. Primary outcome was CD-TLR estimated by Kaplan-Meier method during 18-month follow-up. Univariate logistic regression was used to compare differences in CD-TLR by the type of adjunct therapy used., Results: Among 54 CFA lesions in 50 patients, mean age (SD) was 75(8) years, gender and race were predominantly male (74%, n = 37) and white (94%, n = 47), respectively. Rutherford class III claudication was most common (70%, n = 35) with mean ABI of 0.66 (0.26) and mean angiographic stenosis of 77% (13%). Adjunct use of drug-coated balloon (DCB) angioplasty was 83% (n = 45) and atherectomy was 39% (n = 21). Residual angiographic stenosis was <30% in all cases. Complications included dissection requiring stent placement (2%, n = 1). After 18-months, 18% (n = 9) died unrelated to procedural complications and 6% (n = 3) were lost to follow-up. 18-month cumulative freedom from CD-TLR was 80.6% (95% CI: 69.1%, 92%). Univariate logistic regression did not reveal a statistically significant difference in CD-TLR with type of adjunct therapy used (p > 0.05)., Conclusion: IVL with adjunct use of DCB and/or atherectomy is safe and effective in treatment of calcified CFA disease. Randomized studies are required to confirm these findings., Competing Interests: Declaration of competing interest Dr. Peter Soukas is a site principal investigator for Shockwave Medical Company. Dr. Herbert Aronow is a consultant for Data Safety and Monitoring Board for the Philips ILLUMENATE studies. All other authors have no declaration of interests., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: In-hospital mortality in patients with ST-segment elevation myocardial infarction (STEMI) is higher in those with COVID-19 than in those without COVID-19. The factors that predispose to this mortality rate and their relative contribution are poorly understood. This study developed a risk score inclusive of clinical variables to predict in-hospital mortality in patients with COVID-19 and STEMI., Methods: Baseline demographic, clinical, and procedural data from patients in the North American COVID-19 Myocardial Infarction registry were extracted. Univariable logistic regression was performed using candidate predictor variables, and multivariable logistic regression was performed using backward stepwise selection to identify independent predictors of in-hospital mortality. Independent predictors were assigned a weighted integer, with the sum of the integers yielding the total risk score for each patient., Results: In-hospital mortality occurred in 118 of 425 (28%) patients. Eight variables present at the time of STEMI diagnosis (respiratory rate of >35 breaths/min, cardiogenic shock, oxygen saturation of <93%, age of >55 ​years, infiltrates on chest x-ray, kidney disease, diabetes, and dyspnea) were assigned a weighted integer. In-hospital mortality increased exponentially with increasing integer risk score (Cochran-Armitage χ 2 , P  ​< ​.001), and the model demonstrated good discriminative power (c-statistic ​= ​0.81) and calibration (Hosmer-Lemeshow, P  ​= ​.40). The increasing risk score was strongly associated with in-hospital mortality (3.6%-60% mortality for low-risk and very high-risk score categories, respectively)., Conclusions: The risk of in-hospital mortality in patients with COVID-19 and STEMI can be accurately predicted and discriminated using readily available clinical information., (© 2022 The Author(s).)

The optimal therapy for submassive pulmonary embolism (sPE), defined by right ventricular dysfunction without hemodynamic instability, is uncertain. We conducted a systematic review and meta-analysis to compare the outcomes of catheter-directed thrombolysis (CDT) versus systemic anticoagulation (SA) alone in patients with sPE. We searched PubMed, EMBASE, Cochrane, ClinicalTrials.gov, and Google Scholar (from inception through May 2022) for studies comparing outcomes of CDT versus SA in sPE. Studies were identified, and data were extracted by 2 independent reviewers. We used a random-effects model to calculate risk ratios (RRs) with 95% confidence intervals (CIs). Outcomes included in-hospital, 30-day, 90-day, and 1-year mortality, major and minor bleeding, and need for blood transfusion. A total of 12 studies (1 randomized, 11 observational) with 9,789 patients were included. Compared with SA, CDT was associated with significantly lower in-hospital mortality (RR 0.41, 95% CI 0.30 to 0.56, p &lt;0.00001), 30-day mortality (RR 0.37, 95% CI 0.18 to 0.73, p = 0.004), 90-day mortality (RR 0.36, 95% CI 0.17 to 0.72, p = 0.004), and a tendency toward lower 1-year mortality (RR 0.56, 95% CI 0.29 to 1.05, p = 0.07). The risks of major bleeding (RR 1.31, 95% CI 0.57 to 3.01, p = 0.53), minor bleeding (RR 1.67, 95% CI 0.77 to 3.63, p = 0.20), and the rates of blood transfusion (RR 0.34, 95% CI 0.10 to 1.15, p = 0.08) were similar between the 2 strategies. In conclusion, in patients with sPE, CDT is associated with significantly lower in-hospital, 30-day, and 90-day mortality and a tendency toward lower 1-year mortality with similar bleeding rates compared with SA. This study expands the evidence supporting CDT as first-line therapy for sPE, and randomized controlled trials are indicated to confirm our findings., Competing Interests: Disclosures Dr. Aronow is a Consultant for Philips and Silk Road Medical, neither of which are relevant to the study. The remaining authors have no conflicts of interest to declare., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Preadmission statin therapy is associated with improved outcome in patients hospitalized with COVID-19. Whether inhibition of inflammation and myocardial injury are in part responsible for this observation has not been studied. The aim of the present study was to relate preadmission statin usage to markers of inflammation, myocardial injury, and clinical outcome among patients with established atherosclerosis who were admitted with COVID-19. Adult patients with a diagnosis of coronary artery disease, peripheral artery disease, and/or atherosclerotic cerebrovascular disease who were hospitalized with COVID-19 between March 1, 2020 and December 31, 2020 were included. Statin use was related to the primary composite clinical outcome, death, intensive care unit admission, or thrombotic complications in sequential multivariable logistic regression models. Of 3,584 adult patients who were hospitalized with COVID-19, 1,360 patients met study inclusion criteria (mean age 73.8 years, 45% women, 68% White). Baseline troponin and C-reactive protein were lower in patients on statins before admission. In an unadjusted model, preadmission statin usage was associated with a significant reduction in the primary composite outcome (42.2% vs 53.7%, odds ratio 0.63 [95% confidence interval 0.50 to 0.80], p <0.001). This association remained significant after age, gender, ethnicity, other patient clinical characteristics, and cardiovascular medications were added to the model but became null when troponin and C-reactive protein were also included (odds ratio 0.83 [95% confidence interval 0.63 to 1.09] p = 0.18). In conclusion, among patients with established cardiovascular disease who were hospitalized with COVID-19, preadmission statin therapy was associated with improved in-hospital outcome, an association that was negated once inflammation and myocardial injury were considered., Competing Interests: Disclosures The authors have no conflicts of interest to declare., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: To examine the rate of readmission for permanent pacemaker (PPM) implantation with early versus late discharge after transcatheter aortic valve replacement (TAVR)., Background: There is a current trend toward early discharge after TAVR. However, paucity of data exists on the impact of such practice on readmissions for PPM implantation., Methods: The Nationwide Readmission Database 2016-2018 was queried for all hospitalizations where patients underwent TAVR. Hospitalizations were stratified into early (Days 0 and 1) versus late (≥Day 2) discharge groups. Observations in which PPM was required in the index admission were excluded. Multivariable regression analyses involving patient- and hospital-related variables were utilized. The primary outcome was 90-day readmission for PPM implantation., Results: The final analysis included 68,482 TAVR hospitalizations, 20,261 (29.6%) with early versus 48,221 (70.4%) with late discharge. Early discharge after TAVR increased over the study period (16.2% in 2016 vs. 37.9% in 2018, P trend  < 0.01). Nevertheless, 90-day readmission for PPM implantation remained stable (1.8% in 2016 vs. 2.0% in 2018, P trend  = 0.32). The 90-day readmission rate for PPM implantation (2.0% vs. 1.8%; adjusted odds ratio: 1.15; 95% confidence interval: 0.95-1.39; p = 0.15) and median time-to-readmission (5 days [interquartile range, IQR 3-9] vs. 5 days [IQR 3-14], p = 0.92) were similar with early versus late discharge. Similar rates were observed regardless of whether readmission was elective versus not. Early discharge was associated with lower hospitalization cost ($39,990 ± $13,681 vs. $46,750 ± $18,218, p < 0.01) compared with late discharge., Conclusion: In patients who did not require PPM during the index TAVR hospitalization, the rate of readmission for PPM implantation was similar with early versus late discharge., (© 2022 Wiley Periodicals LLC.)

The Coronavirus 2019 (COVID-19) pandemic, caused by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) virus, has resulted in unprecedented morbidity and mortality worldwide. While COVID-19 typically presents as viral pneumonia, cardiovascular manifestations such as acute coronary syndromes, arterial and venous thrombosis, acutely decompensated heart failure (HF), and arrhythmia are frequently observed. Many of these complications are associated with poorer outcomes, including death. Herein we review the relationship between cardiovascular risk factors and outcomes among patients with COVID-19, cardiovascular manifestations of COVID-19, and cardiovascular complications associated with COVID-19 vaccination., Competing Interests: Disclosure The authors have nothing to disclose., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Intravascular lithotripsy (IVL) is a novel tool for the treatment of calcified vascular stenosis. Recently, IVL has been successfully used for modification of calcified plaque in coronary and lower extremity peripheral arteries with promising results. However, experience in subclavian and innominate peripheral arterial disease is limited. This study aims to report our initial experience of IVL use in calcified subclavian and innominate vasculature., Methods: This was a retrospective review of all the cases of IVL performed in subclavian and innominate arteries at the Miriam Hospital, Providence, between January 2019 and May 2020. Data on the baseline and procedural characteristics were collected. The primary endpoint was procedural success defined as residual stenosis of <20% after stenting. Other endpoints of interest were; 1) procedural complications, including dissections, perforations, abrupt closure, slow or no-reflow, thrombosis, and distal embolization; 2) in-hospital major adverse cardiac events (MACE) defined as a composite of death, myocardial infarction, or stroke/transient ischemic attack., Results: A total of 7 patients with 13 lesions undergoing IVL were included. Of these, 5 (71%) were women, the mean age was 74.6 ± 12.9, and the mean BMI was 25.1 ± 6.7. IVL was successfully delivered to all the target lesions with a mean 252.9 ± 54.4 pulses delivered per patient. Procedural success was achieved in 100% of the treated lesions. No procedure-related complications or in-hospital MACE occurred in any of the patients., Conclusions: In this single-center retrospective analysis, IVL facilitated acute procedural success without any procedural complications in severely calcified stenoses of the subclavian and innominate vasculature. Larger studies with an active comparator and longer follow-up are needed to establish the relative efficacy and safety of IVL use in this vascular bed., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background We aimed to characterize the occurrence of major adverse cardiovascular and limb events (MACE and MALE) among patients with peripheral artery disease (PAD) undergoing peripheral vascular intervention (PVI), as well as associated factors in patients with chronic limb threatening ischemia (CLTI). Methods and Results Patients undergoing PVI in the American College of Cardiology's (ACC) National Cardiovascular Data Registry's PVI Registry who could be linked to Centers for Medicare and Medicaid Services data were included. The primary outcomes were MACE, MALE, and readmission within 1 month and 1 year following index CLTI-PVI or non-CLTI-PVI. Cox proportional hazards regression was used to identify factors associated with the development of the primary outcomes among patients undergoing CLTI-PVI. There were 1758 (49.7%) patients undergoing CLTI-PVI and 1779 (50.3%) undergoing non-CLTI-PVI. By 1 year, MACE occurred in 29.5% of patients with CLTI (n=519), and MALE occurred in 34.0% of patients with CLTI (n=598). By 1 year, MACE occurred in 8.2% of patients with non-CLTI (n=146), and MALE occurred in 26.1% of patients with non-CLTI (n=465). Predictors of MACE at 1 year in CLTI-PVI included end-stage renal disease on hemodialysis, congestive heart failure, prior CABG, and severe lung disease. Predictors of MALE at 1 year in CLTI-PVI included treatment of a prior bypass graft, profunda femoral artery treatment, end-stage renal disease on hemodialysis, and treatment of a previously treated lesion. Conclusions Patients ≥65 years old undergoing PVI experience high rates of MACE and MALE. A range of modifiable and non-modifiable patient factors, procedural characteristics, and medications are associated with the occurrence of MACE and MALE following CLTI-PVI.

Background: Lifestyle changes and medications are recommended as the first line of treatment for claudication, with revascularization considered for treatment-resistant symptoms, based on patients' preferences. Real-world evidence comparing health status outcomes of early invasive with noninvasive management strategies is lacking., Methods: In the international multicenter prospective observational PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry, disease-specific health status was assessed by the Peripheral Artery Questionnaire in patients with new-onset or worsening claudication at presentation and 3, 6, and 12 months later. One-year health status trajectories were compared by early revascularization versus noninvasive management on a propensity-matched sample using hierarchical generalized linear models for repeated measures adjusted for baseline health status., Results: In a propensity-matched sample of 1000 patients (67.4±9.3 years, 62.8% male, and 82.4% White), 297 (29.7%) underwent early revascularization and 703 (70.3%) were managed noninvasively. Over 1 year of follow-up, patients who underwent early invasive management reported significantly higher health status than patients managed noninvasively (interaction term for time and treatment strategy; P <0.001 for all Peripheral Artery Questionnaire domains). The average 1-year change in Peripheral Artery Questionnaire summary scores was 30.8±25.2 in those undergoing early invasive, compared with 16.7±23.4 in those treated noninvasively ( P <0.001)., Conclusions: Patients with claudication undergoing early invasive treatment had greater health status improvements over the course of 1 year than those treated noninvasively. These data can be used to support shared decision-making with patients., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT01419080.

Background: Common femoral artery (CFA) disease is often heavily calcified and prone to low patency rates with endovascular treatment compared with surgical endarterectomy. Recent data suggest promising short-term outcomes with the adjunct use of intravascular lithotripsy; however, data on its midterm effectiveness are lacking. We compared clinically driven target lesion revascularization (CD-TLR) between patients receiving drug-coated balloon angioplasty with adjunct intravascular lithotripsy (IVL-DCB) vs adjunct atherectomy (Ath-DCB) for treatment of CFA disease., Methods: In a single-center retrospective cohort study, patients receiving IVL-DCB vs Ath-DCB for symptomatic CFA disease from January 2015 to March 2020 were included. The primary outcome was cumulative CD-TLR with angiographic restenosis ≥50%, estimated by Kaplan-Meier analysis during 18-month follow-up and compared by log-rank test., Results: Total of 68 CFA lesions (Ath-DCB, 35; IVL-DCB, 33) were included. Patients had a mean age (standard deviation) of 72 (8) years and were predominantly male (63.3%) and White (92%). Mean baseline angiographic stenosis was 78% (11) in the Ath-DCB group and 70% (10) in the IVL-DCB group ( P = .002). Technical success was 100% in both groups. One flow-limiting dissection occurred in IVL-DCB requiring stent placement, whereas 2 bailout stentings were performed in the Ath-DCB group. Cumulative Kaplan-Meier freedom from CD-TLR was 91.2% (95% CI, 81.6%-100%) in the Ath-DCB group vs 79.4% (95% CI, 64.6%-94.2%) in the IVL-DCB group (Log-rank P = .167)., Conclusions: The safety and effectiveness of IVL-DCB were comparable to those of Ath-DCB in the treatment of calcified CFA disease during the 18-month follow-up. Further studies are required to verify these findings., Competing Interests: Dr Soukas is a site principal investigator for Shockwave Medical. Dr Aronow is on the data safety and monitoring board for the Philips ILLUMENATE studies. All other authors have no declaration of interests. The authors received no specific funding for this work., (© 2022 The Author(s).)