Device regulation and surveillance in vascular care: Challenges and opportunities.

Cardiovascular devices are essential for the treatment of cardiovascular diseases including cerebrovascular, coronary, valvular, congenital, peripheral vascular and arrhythmic diseases. The regulation and surveillance of vascular devices in real-world practice, however, presents challenges during each individual product's life cycle. Four examples illustrate recent challenges and questions regarding safety, appropriate use and efficacy arising from FDA approved devices used in real-world practice. We outline potential pathways wherein providers, regulators and payors could potentially provide high-quality cardiovascular care, identify safety signals, ensure equitable device access, and study potential issues with devices in real-world practice.

Hospital-Level Variability in Reporting of Ischemic Stroke Subtypes and Supporting Diagnostic Evaluation in GWTG-Stroke Registry.

BACKGROUND: Secondary prevention of ischemic stroke (IS) requires adequate diagnostic evaluation to identify the likely etiologic subtype. We describe hospital-level variability in diagnostic testing and IS subtyping in a large nationwide registry. METHODS AND RESULTS: We used the GWTG-Stroke (Get With The Guidelines-Stroke) registry to identify patients hospitalized with a diagnosis of acute IS at 1906 hospitals between January 1, 2016, and September 30, 2017. We compared the documentation rates and presence of risk factors, diagnostic testing, achievement/quality measures, and outcomes between patients with and without reported IS subtype. Recording of diagnostic evaluation was optional in all IS subtypes except cryptogenic, where it was required. Of 607 563 patients with IS, etiologic IS subtype was documented in 57.4% and missing in 42.6%. Both the rate of missing stroke pathogenesis and the proportion of cryptogenic strokes were highly variable across hospitals. Patients missing stroke pathogenesis less frequently had documentation of risk factors, evidence-based interventions, or discharge to home. The reported rates of major diagnostic testing, including echocardiography, carotid and intracranial vascular imaging, and short-term cardiac monitoring were <50% in patients with documented IS pathogenesis, although these variables were missing in >40% of patients. Long-term cardiac rhythm monitoring was rarely reported, even in cryptogenic stroke. CONCLUSIONS: Reporting of IS etiologic subtype and supporting diagnostic testing was low overall, with high rates of missing optional data. Improvement in the capture of these data elements is needed to identify opportunities for quality improvement in the diagnostic evaluation and secondary prevention of stroke.

REAFFIRMING THE CORE VALUES OF ACADEMIC CARDIOLOGY.

Academic medical centers are rapidly evolving into academic health systems with expanding clinical activity. These changes coupled with financial pressures due to decreased clinical reimbursements and failure of the NHLBI budget to keep pace with inflation are challenging the ability to succeed in all our missions. New governance structures and financial models may be necessary to success in our research and educational missions.

The changing landscape of interventional cardiology: A survival guide in the era of health system consolidation: The Society of Cardiovascular Angiography and Interventions affirms the value of this manuscript.

Practice environments for interventional cardiologists have evolved dramatically and now include small independent practices, large cardiology groups, multispecialty groups, and large integrated health systems. Increasingly, cardiologists are employed by hospitals or health systems. Data from MedAxiom and the American College of Cardiology (ACC) demonstrate an exponential increase in the percentage of cardiologists in employed positions from 10% in 2009 to 87% in 2020. This white paper explores these profound changes, considers their impact on interventional cardiologists, and offers guidance on how interventional cardiologists can best navigate this challenging environment. Finally, the paper offers a potential model to improve the employed physician experience through greater physician involvement in decision making, which may increase jobs satisfaction.

Position Statement on Vascular Access Safety for Percutaneous Devices in AMI Complicated by Cardiogenic Shock.

In the United States, the frequency of using percutaneous mechanical circulatory support devices for acute myocardial infarction complicated by cardiogenic shock is increasing. These devices require large-bore vascular access to provide left, right, or biventricular cardiac support, frequently under urgent/emergent circumstances. Significant technical and logistical variability exists in device insertion, care, and removal in the cardiac catheterization laboratory and in the cardiac intensive care unit. This variability in practice may contribute to adverse outcomes observed in centers that receive patients with cardiogenic shock, who are at higher risk for circulatory insufficiency, venous stasis, bleeding, and arterial hypoperfusion. In this position statement, we aim to: 1) describe the public health impact of bleeding and vascular complications in cardiogenic shock; 2) highlight knowledge gaps for vascular safety and provide a roadmap for a regulatory perspective necessary for advancing the field; 3) propose a minimum core set of process elements, or "vascular safety bundle"; and 4) develop a possible study design for a pragmatic trial platform to evaluate which structured approach to vascular access drives most benefit and prevents vascular and bleeding complications in practice.

Incidence and outcomes of cardiogenic shock among women with spontaneous coronary artery dissection.

BACKGROUND: There is a paucity of data on cardiogenic shock (CS) incidence and outcomes among patients with spontaneous coronary artery dissection (SCAD). METHODS: Women admitted to the hospital for acute myocardial infarction (AMI) with and without SCAD were identified from the United States National Readmission Database from October 1, 2015 to December 31, 2018. We calculated the incidence of CS among women with AMI with and without SCAD and odds for developing CS after adjusting for baseline characteristics. In addition, we report the utilization of percutaneous coronary intervention, mechanical circulatory support, severe disability surrogates, and 30-day readmission rates. RESULTS: A total of 664,292 patients admitted for AMI were eligible for analysis, including 6643 patients with SCAD and 657,649 without SCAD. Patients with SCAD were younger (57 years [interquartile range, IQR 48-68] vs. 71 years [IQR 60-81], p < 0.01) and had fewer comorbidities yet had a higher incidence of CS as compared to patients without SCAD (9% vs. 5%, p < 0.01) and remained at elevated risk after adjusting for baseline comorbidities (adjusted odds ratio 1.5 [95% confidence interval, CI 1.2-1.7]). Among patients who developed CS, those with SCAD had lower in-hospital mortality than non-SCAD (31% vs. 39%, p < 0.01), and were more likely to receive mechanical circulatory support. CONCLUSIONS: In a nationally representative sample of women admitted for AMI, we found that patients with SCAD had a higher risk of developing CS and required more frequent use of mechanical circulatory support but were more likely to survive to discharge than women suffering AMI from causes other than SCAD.

Tricuspid Valve Percutaneous Therapies.

PURPOSE OF REVIEW: In this review, we have focused on the currently available transcatheter tricuspid valve therapies, device selection, as well as role and management of tricuspid regurgitation (TR) in the setting of other transcatheter valvular procedures. RECENT FINDINGS: In this review, we have enlisted the recently finished as well as ongoing trials in the percutaneous tricuspid valve therapies. TR is highly prevalent yet remains underrecognized and is often untreated. TR has traditionally been managed conservatively with medical therapies including diuretics for volume management, whereas surgical therapies are reserved for those undergoing left-sided valvular surgery. Although the transcatheter devices for tricuspid repair and replacement are in clinical trials, the experience to date for their effectiveness and safety has been reassuring.

Novel method for left ventricular unloading utilizing percutaneous pulmonary artery drainage in cardiorespiratory failure due to COVID-19 infection.

Left ventricular (LV) unloading is an important concept in patients undergoing peripheral venoarterial extracorporeal membrane oxygenation (VA-ECMO). We present a case of a 32-year-old male in acute cardiorespiratory collapse due to coronavirus disease (COVID-19) who underwent VA-ECMO cannulation in the setting of cardiogenic shock and acute respiratory distress syndrome. Due to inability to utilize percutaneous LV assist device (pLVAD) for LV unloading due to small end diastolic dimension, alternative strategies were explored. A traditionally utilized right ventricular support device, the ProTek Duo (TandemLife, Pittsburgh, PA), was utilized to drain the pulmonary artery, leading to improvement in parameters for cardiogenic shock. To our knowledge, this is the first case in which a ProTek Duo has been utilized in conjunction with VA-ECMO to provide LV unloading in support of a patient in cardiogenic shock. This method can be employed in future challenging situations where pLVAD is not feasible.

Age stratified sex-related differences in incidence, management, and outcomes of cardiogenic shock.

BACKGROUND: There is a lack of data on age-stratified sex differences in the incidence, treatment, and outcomes of cardiogenic shock (CS). We sought to study these differences from a contemporary database. METHODS: Patients admitted with CS (2004-2018) were identified from the United States National Inpatient Sample. We compared CS (acute myocardial infarction-related cardiogenic shock [AMI-CS] and non-acute myocardial infarction-related cardiogenic shock [Non-AMI-CS]) incidence, management, and outcomes in males and females, stratified into four age groups (20-44, 45-64, 65-84, and ≥85 years of age). Propensity score matching (PSM) was used for adjustment. RESULTS: A total of 1,506,281 weighted hospitalizations for CS were included (AMI-CS, 39%; Non-AMI-CS, 61%). Across all age groups, females had a lower incidence of CS compared with males. After PSM and among the AMI-CS cohort, higher mortality among females compared with males was observed in the age groups 45-64 (28.5% vs. 26.3%) and 65-84 years (39.3% vs. 37.9%) (p < 0.01, for all). Among the Non-AMI-CS cohort, higher mortality among females compared with males was observed in the age groups 20-44 (33.5% vs. 30.5%), 45-64 (35.1% vs. 31.9%), and 65-84 years (41.7% vs. 40.3%) (p < 0.01, for all). Similar age-dependent differences in the management of CS were also observed between females and males. CONCLUSIONS: Females have a lower incidence of CS regardless of age. Significant disparities in the management and outcomes of CS were observed based on sex. However, these disparities varied by age and etiology of CS (AMI-CS vs. Non-AMI-CS) with pronounced disparity among females in the age range of 45-84 years.

Spontaneous coronary artery dissection of the left anterior descending artery in a patient with COVID-19 infection.

A 48-year-old woman with a past medical history of migraines and hyperlipidemia presented due to severe retrosternal chest pain with no other associated signs or symptoms. The patient was hemodynamically stable and was found to have an elevated troponin with electrocardiogram showing no ischemic changes. Computed tomography of the coronary arteries showed a left dominant system with dissection extending from the mid-to-distal left anterior descending (LAD) artery. The patient was subsequently discharged on medical therapy but returned 3 days later due to worsening chest pain. Electrocardiogram revealed inferior and anteroseptal ST segment changes with peak troponin of 14.9 ng/ml (reference range <0.80 ng/ml). Coronavirus disease 2019 (COVID-19) nasopharyngeal swab was performed prior to urgent coronary angiogram. Coronary angiogram was performed with full personal protective equipment for respiratory and droplet precautions due to pending COVID-19 testing results. Angiogram revealed spontaneous coronary artery dissection (SCAD) extending from the ostium of the LAD to the distal vessel. COVID-19 testing returned positive while in intensive care unit. The patient was not a percutaneous coronary intervention candidate due to the extent of the dissection and was not a surgical candidate due to a lack of graftable target and medical management was continued. To our knowledge, this case is the first in which SCAD has been reported in the LAD in a patient with COVID-19 with no other symptoms of respiratory illness or symptoms classically associated with the novel coronavirus. SCAD should be considered on the differential as one of the various cardiac manifestations of COVID-19 infection.

A Comprehensive Update on Aspirin Management During Noncardiac Surgery.

Aspirin is considered critical lifelong therapy for patients with established cardiovascular (CV) disease (including coronary artery, cerebrovascular, and peripheral arterial diseases) and is consequently one of the most widely used medications worldwide. However, the indications for aspirin use continue to evolve and recent trials question its efficacy for primary prevention. Although one third of patients undergoing noncardiac surgery and at risk for a major adverse CV event receive aspirin perioperatively, uncertainty still exists about how aspirin should be optimally managed in this context, and significant practice variability remains. Recent trials suggest that the risks of continuing aspirin during the perioperative period outweigh the benefits in many cases, but data on patients with high CV risk remain limited. We performed a comprehensive PubMed and Medline literature search using the following keywords: aspirin, aspirin withdrawal, perioperative, coronary artery disease, cerebrovascular disease, peripheral artery disease, and CV disease; we manually reviewed all relevant citations for inclusion. Patients taking aspirin for the primary prevention of CV disease should likely discontinue it during the perioperative period, especially when there is a high risk of bleeding. Patients with established CV disease but without a coronary stent should likely continue aspirin during the perioperative period unless undergoing closed-space surgery. Patients with a history of coronary stenting also likely need aspirin continuation throughout the perioperative period for nonclosed space procedures. Perioperative clinicians need to balance the risks of ceasing aspirin before surgery against its continuation during the perioperative interval using a patient-specific strategy. The guidance on decision-making with regard to perioperative aspirin cessation or continuation using currently available clinical data from studies in high-risk patients along with nonclinical aspirin studies is conflicting and does not enable a simplified or unified answer. However, pertinent guidelines on CV disease management provide a basic framework for aspirin management, and large trial findings provide some insight into the safety of perioperative aspirin cessation in some contexts, although uncertainty on perioperative aspirin still exists. This review provides an evidence-based update on perioperative aspirin management in patients undergoing noncardiac surgery with a focus on recommendations for perioperative clinicians on continuing versus holding aspirin during this context.

Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions 2020 think tank.

The society for cardiovascular angiography and interventions (SCAI) think tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community for high-level field-wide discussions. The 2020 think tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease (CHD). Each session was moderated by a senior content expert and co-moderated by a member of SCAI's emerging leader mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialogue from a broader base, and thereby aid SCAI and the industry community in developing specific action items to move these areas forward.