Characteristics of clinical trials evaluating cardiovascular therapies for Coronavirus Disease 2019 Registered on ClinicalTrials.gov: a cross sectional analysis.

Morbidity and mortality associated with COVID-19 has increased exponentially, and patients with cardiovascular (CV) disease are at risk for poor outcomes. Several lines of evidence suggest a potential role for CV therapies in COVID-19 treatment. Characteristics of clinical trials of CV therapies related to COVID-19 registered on ClinicalTrials.gov have not been described. METHODS: ClinicalTrials.gov was queried on August 7, 2020 for COVID-19 related trials. Studies evaluating established CV drugs, other fibrinolytics (defibrotide), and extracorporeal membrane oxygenation were included. Studies evaluating anti-microbial, convalescent plasma, non-colchicine anti-inflammatory, and other therapies were excluded. Trial characteristics were tabulated from study-specific entries. RESULTS: A total of 2,935 studies related to COVID-19 were registered as of August 7, 2020. Of these, 1,645 were interventional studies, and the final analytic cohort consisted of 114 studies evaluating 10 CV therapeutic categories. Antithrombotics (32.5%; n = 37) were most commonly evaluated, followed by pulmonary vasodilators (14.0%; n = 16), renin-angiotensin-aldosterone system-related therapies (12.3%; n = 14), and colchicine (8.8%; n = 10). Trials evaluating multiple CV therapy categories and CV therapies in combination with non-CV therapies encompassed 4.4% (n = 5) and 9.6% (n = 11) of studies, respectively. Most studies were designed for randomized allocation (87.7%; n = 100), enrollment of less than 1000 participants (86.8%; n = 99), single site implementation (55.3%; n = 63), and had a primary outcome of mortality or a composite including mortality (56.1%; n = 64). Most study populations consisted of patients hospitalized with COVID-19 (81.6%; n = 93). At the time of database query, 28.9% (n = 33) of studies were not yet recruiting and the majority were estimated to be completed after December 2020 (67.8%; n = 78). Most lead sponsors were located in North America (43.9%; n = 50) or Europe (36.0%; n = 41). CONCLUSIONS: A minority (7%) of clinical trials related to COVID-19 registered on ClinicalTrials.gov plan to evaluate CV therapies. Of CV therapy studies, most were planned to be single center, enroll less than 1000 inpatients, sponsored by European or North American academic institutions, and estimated to complete after December 2020. Collectively, these findings underscore the need for a network of sites with a platform protocol for rapid evaluation of multiple therapies and generalizability to inform clinical care and health policy for COVID-19 moving forward.

Clinical utility of cerebral angiography in the preoperative assessment of endocarditis.

Cerebral angiography is an invasive procedure utilized without supporting guidelines in preoperative evaluations of infective endocarditis (IE). It is used to identify mycotic intracranial aneurysm, which is suspected to increase the risk of intracranial bleeding during cardiac surgery. Our objectives were to: (1) assess the utility of cerebral angiography by determining which subset of IE patients benefit from its performance; and (2) identify clinical and noninvasive screening tests that can preclude the need for invasive cerebral angiography. Retrospective analysis was performed of all patients treated surgically for IE from 7/2007 to 1/2012 and discharged with medical treatment for IE from 7/2007 to 7/2009 presenting to a large academic center. Of the 151 patients who underwent cerebral angiography, mycotic aneurysm was identified in seven (prevalence=4.6%; 95% CI 2.3-9.3%). Five had viridans group streptococci as the causative IE microorganism (p=0.0017). Noninvasive imaging and particularly absence of intracranial bleed on magnetic resonance imaging conveys a negative predictive value (NPV) of 0.977 (95% CI 0.879-0.996). Absence of a focal neurologic deficit or altered mental status convey a NPV of 0.990 (95% CI 0.945-0.998) and 0.944 (95% CI 0.883-0.974), respectively. Clinical suspicion for mycotic aneurysm and thus utilization of cerebral angiography is likely necessary only in the setting of acute neurologic deficits and when noninvasive imaging demonstrates acute intracranial bleed. A novel association between viridans group streptococci and intracranial mycotic aneurysm is demonstrated.

Sex in cardiovascular disease: Why this biological variable should be considered in in vitro models.

Cardiovascular disease (CVD), the world's leading cause of death, exhibits notable epidemiological, clinical, and pathophysiological differences between sexes. Many such differences can be linked back to cardiovascular sexual dimorphism, yet sex-specific in vitro models are still not the norm. A lack of sex reporting and apparent male bias raises the question of whether in vitro CVD models faithfully recapitulate the biology of intended treatment recipients. To ensure equitable treatment for the overlooked female patient population, sex as a biological variable (SABV) inclusion must become commonplace in CVD preclinical research. Here, we discuss the role of sex in CVD and underlying cardiovascular (patho)physiology. We review shortcomings in current SABV practices, describe the relevance of sex, and highlight emerging strategies for SABV inclusion in three major in vitro model types: primary cell, stem cell, and three-dimensional models. Last, we identify key barriers to inclusive design and suggest techniques for overcoming them.

Clinical Outcomes of Non-Stent-Based Interventions for Symptomatic Below-the-Knee Peripheral Artery Disease in the Excellence in Peripheral Artery Disease (XLPAD) Registry.

For endovascular treatment of below-the-knee (BTK) peripheral artery disease (PAD), independently adjudicated real-world outcomes comparing non-stent-based balloon angioplasty (percutaneous transluminal angioplasty) and adjunctive treatments with or without a concomitant ipsilateral femoropopliteal (FP) artery intervention are scarce. A total of 1,060 patients from the multicenter XLPAD registry who underwent non-stent-based BTK PAD intervention between 2006 and 2021 were included. The primary outcome was the 1-year incidence of major adverse limb events (MALEs), a composite of all-cause death, any amputation, or clinically driven repeat revascularization. A total of 566 patients underwent BTK and 494 BTK + FP interventions; 72% were men, with a mean age of 68.4 ± 10.9 years. Diabetes mellitus was more prevalent in the BTK-only group (76.5% vs 69%, p = 0.006). Mean Rutherford class was 4.2 ± 1.18; chronic limb-threatening ischemia was more frequent in the BTK group (55.3% vs 49%, p = 0.040). Moderate to severe calcification was more frequent in the BTK + FP group (21.2% vs 27.1%, p = 0.024), as was lesion length (110.6 ± 77.3 vs 135.4 ± 86.3 mm, p <0.001). Nearly 81% of lesions were treated with percutaneous transluminal angioplasty. Drug-coated balloon (1.6% vs 14%, p <0.001) and atherectomy (38% vs 58.5%, p <0.001) use was more frequent in the BTK + FP group. The rate of procedural success was higher in the BTK + FP group (86% vs 91%, p = 0.009), with amputation being the most common complication at 3.3% within 30 days after the procedure. The rates of 1-year MALE (21.2% vs 22.3%, p = 0.675) and mortality (4.6% vs 3.4%, p = 0.3) were similar between the BTK and BTK + FP groups. Nonstent treatment for BTK PAD with concomitant FP intervention leads to high procedural success and similar rates of 1-year MALE compared with isolated BTK intervention. Condensed Abstract: The vast majority of below-the-knee (BTK) peripheral artery disease (PAD) interventions are performed with balloon angioplasty. Presence of inflow femoropopliteal PAD in patients who undergo BTK interventions can affect the outcome of the procedure. This report explores immediate procedural success and major adverse limb events at 1 year after balloon angioplasty treatment for isolated BTK PAD and in patients who underwent an additional femoropopliteal PAD intervention.

Emergent precordial percussion revisited--pacing the heart in asystole.

Precordial percussion is a technique by which a manual force is applied repeatedly to the chest of a patient experiencing an unstable bradycardic or asystolic rhythm. The force is used not to defibrillate the myocardium as is the case with the "precordial thump" in pulseless ventricular tachycardia/ventricular fibrillation but rather to initiate a current through the myocardium in the form of an essentially mechanically paced beat. In this review, we discuss the physiology and utility of precordial percussion, or precordial thump, in the emergency setting as a very temporary bridge to more effective and permanent pacing techniques.

The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System.

BACKGROUND: A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has issued multiple advisories regarding paclitaxel use. We analyzed how this controversy impacted device purchasing and related utilization patterns in the period immediately following publication of the meta-analysis. METHODS AND RESULTS: Ascension Healthcare System purchase data over a 14-month period were synthesized across centers for both paclitaxel and non-paclitaxel devices. A fixed-effects regression model and a binary regression model with facility-level controls were used to compare purchasing patterns before and after the meta-analysis. Purchase volumes of each paclitaxel device fell. Pooled purchase volumes of all paclitaxel devices decreased from a 14-month peak of 631 devices in October 2018 to a 14-month nadir of 359 devices in February 2019. An F-test comparing the pooled-month specific fixed effects for the months before vs after the publication of the meta-analysis has an F-statistic of 11.64, suggesting that average purchasing levels in the two periods are statistically different (P<.001). Utilization of non-paclitaxel devices did not decline. CONCLUSIONS: Purchase volumes of paclitaxel devices decreased immediately during the months following publication of the related meta-analysis. Total Ascension-wide paclitaxel device purchase volume in February 2019 demonstrated a 43.1% reduction from peak monthly purchase volume during the assessed period and a 32.5% reduction compared with November 2019, the last month preceding publication of the meta-analysis.

Clinical Decision Support for Peripheral Artery Disease: Answering the Call.

See Article by Arruda-Olson et al.

Management of Complications.

Percutaneous coronary intervention (PCI) has matured rapidly to tackle increasingly complex coronary disease. Operators must be aware of the incidence of the basic risks involved with coronary angiography and PCI to appropriately inform patients and obtain procedural consent. Even before a wire enters a coronary artery, specific risks, including vascular access complications, renal injury, allergic reaction, and radiation injury, are constantly present. With initiation of PCI, new risks to the coronary circulation arise. A fundamental knowledge of the presentation of these complications and expert ability to emergently manage them are of the utmost importance to the successful completion of PCI.

Multidisciplinary pulmonary embolism response teams and systems.

Pulmonary embolism (PE) is a complex diagnosis that encompasses a wide range of clinical presentations. Often patients who present with PE have complicated medical histories which can make their management challenging. Many novel therapeutic strategies and tools are emerging to improve the care and outcomes of patients with PE. Pulmonary embolism response teams (PERTs) are developing at multiple centers to improve the decision making, efficiency and orchestration of these clinical strategies. Concordantly with development of PERT programs is the design and implementation of systems to allow for numerous specialists to convene and discuss complex PE patients in real time. The mechanisms to engage a multidisciplinary approach are proving to be an invaluable resource in the decision making processes and treatment of high risk PE patients. Ultimately, other multi-disciplinary teams may adopt these methods to better address their clinical needs.

In-hospital cardiac arrest.

In-hospital sudden cardiac arrest and resuscitation is distinct from out-of-hospital sudden cardiac arrest (OOHSCA) and warrants specific attention. Sudden cardiac arrest (SCA) is a manifestation of an underlying process rather than a disease itself. The complex, multiorgan system dysfunction common among the inpatient population can precipitate SCA by both similar and very different mechanisms than OOHSCA. The diagnostic and treatment algorithms of SCA remain largely the same between the inpatient and outpatient arenas. The application of complex diagnostic and therapeutic interventions is permissible, but such tools must not interrupt or delay the important basics of cardiac arrest management in the inpatient setting, including adequate chest compressions and timely defibrillation when appropriate.

Electrical therapies in cardiac arrest.

Recognition and appropriate treatment of ventricular fibrillation or pulseless ventricular tachycardia is an essential skill for healthcare providers. Appropriate defibrillation can improve survival and benefit patient outcome. Similarly, increased public access to automatic electronic defibrillators has been shown to improve out-of-hospital survival for cardiac arrest. When combined with high-quality cardiopulmonary resuscitation, electrical therapies are an important aspect of resuscitation in the patient with cardiac arrest. This article focuses on the use of electrical therapies, including defibrillation, cardiac pacing, and automated external defibrillators, in cardiac arrest.