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The New England Journal of Medicine Sep 2023Device-detected atrial high-rate episodes (AHREs) are atrial arrhythmias detected by implanted cardiac devices. AHREs resemble atrial fibrillation but are rare and... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Device-detected atrial high-rate episodes (AHREs) are atrial arrhythmias detected by implanted cardiac devices. AHREs resemble atrial fibrillation but are rare and brief. Whether the occurrence of AHREs in patients without atrial fibrillation (as documented on a conventional electrocardiogram [ECG]) justifies the initiation of anticoagulants is not known.
METHODS
We conducted an event-driven, double-blind, double-dummy, randomized trial involving patients 65 years of age or older who had AHREs lasting for at least 6 minutes and who had at least one additional risk factor for stroke. Patients were randomly assigned in a 1:1 ratio to receive edoxaban or placebo. The primary efficacy outcome was a composite of cardiovascular death, stroke, or systemic embolism, evaluated in a time-to-event analysis. The safety outcome was a composite of death from any cause or major bleeding.
RESULTS
The analysis population consisted of 2536 patients (1270 in the edoxaban group and 1266 in the placebo group). The mean age was 78 years, 37.4% were women, and the median duration of AHREs was 2.8 hours. The trial was terminated early, at a median follow-up of 21 months, on the basis of safety concerns and the results of an independent, informal assessment of futility for the efficacy of edoxaban; at termination, the planned enrollment had been completed. A primary efficacy outcome event occurred in 83 patients (3.2% per patient-year) in the edoxaban group and in 101 patients (4.0% per patient-year) in the placebo group (hazard ratio, 0.81; 95% confidence interval [CI], 0.60 to 1.08; P = 0.15). The incidence of stroke was approximately 1% per patient-year in both groups. A safety outcome event occurred in 149 patients (5.9% per patient-year) in the edoxaban group and in 114 patients (4.5% per patient-year) in the placebo group (hazard ratio, 1.31; 95% CI, 1.02 to 1.67; P = 0.03). ECG-diagnosed atrial fibrillation developed in 462 of 2536 patients (18.2% total, 8.7% per patient-year).
CONCLUSIONS
Among patients with AHREs detected by implantable devices, anticoagulation with edoxaban did not significantly reduce the incidence of a composite of cardiovascular death, stroke, or systemic embolism as compared with placebo, but it led to a higher incidence of a composite of death or major bleeding. The incidence of stroke was low in both groups. (Funded by the German Center for Cardiovascular Research and others; NOAH-AFNET 6 ClinicalTrials.gov number, NCT02618577; ISRCTN number, ISRCTN17309850.).
Topics: Aged; Female; Humans; Male; Anticoagulants; Atrial Fibrillation; Embolism; Factor Xa Inhibitors; Hemorrhage; Stroke; Electrodes, Implanted; Double-Blind Method; Arrhythmias, Cardiac; Risk Factors
PubMed: 37622677
DOI: 10.1056/NEJMoa2303062 -
Medical Sciences (Basel, Switzerland) Aug 2023Venous thromboembolism (VTE), comprising pulmonary embolism (PE) and deep vein thrombosis (DVT), poses a significant risk during and after hospitalization, particularly... (Review)
Review
Venous thromboembolism (VTE), comprising pulmonary embolism (PE) and deep vein thrombosis (DVT), poses a significant risk during and after hospitalization, particularly for surgical patients. Among various patient groups, those undergoing major orthopedic surgeries are considered to have a higher susceptibility to PE and DVT. Major lower-extremity orthopedic procedures carry a higher risk of symptomatic VTE compared to most other surgeries, with an estimated incidence of ~4%. The greatest risk period occurs within the first 7-14 days following surgery. Major bleeding is also more prevalent in these surgeries compared to others, with rates estimated between 2% and 4%. For patients undergoing major lower-extremity orthopedic surgery who have a low bleeding risk, it is recommended to use pharmacological thromboprophylaxis with or without mechanical devices. The choice of the initial agent depends on the specific surgery and patient comorbidities. First-line options include low-molecular-weight heparins (LMWHs), direct oral anticoagulants, and aspirin. Second-line options consist of unfractionated heparin (UFH), fondaparinux, and warfarin. For most patients undergoing knee or hip arthroplasty, the initial agents recommended for the early perioperative period are LMWHs (enoxaparin or dalteparin) or direct oral anticoagulants (rivaroxaban or apixaban). In the case of hip fracture surgery, LMWH is recommended as the preferred agent for the entire duration of prophylaxis. However, emerging factor XI(a) inhibitors, as revealed by a recent meta-analysis, have shown a substantial decrease in the occurrence of VTE and bleeding events among patients undergoing major orthopedic surgery. This discovery poses a challenge to the existing paradigm of anticoagulant therapy in this specific patient population and indicates that factor XI(a) inhibitors hold great promise as a potential strategy to be taken into serious consideration.
Topics: Humans; Factor XIa; Anticoagulants; Venous Thromboembolism; Heparin, Low-Molecular-Weight; Heparin; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Pulmonary Embolism
PubMed: 37606428
DOI: 10.3390/medsci11030049 -
American Heart Journal Dec 2023The identification of hemodynamically stable pulmonary embolism (PE) patients who may benefit from advanced treatment beyond anticoagulation is unclear. However, when... (Randomized Controlled Trial)
Randomized Controlled Trial
Randomized controlled trial of mechanical thrombectomy vs catheter-directed thrombolysis for acute hemodynamically stable pulmonary embolism: Rationale and design of the PEERLESS study.
BACKGROUND
The identification of hemodynamically stable pulmonary embolism (PE) patients who may benefit from advanced treatment beyond anticoagulation is unclear. However, when intervention is deemed necessary by the PE patient's care team, data to select the most advantageous interventional treatment option are lacking. Limiting factors include major bleeding risks with systemic and locally delivered thrombolytics and the overall lack of randomized controlled trial (RCT) data for interventional treatment strategies. Considering the expansion of the pulmonary embolism response team (PERT) model, corresponding rise in interventional treatment, and number of thrombolytic and nonthrombolytic catheter-directed devices coming to market, robust evidence is needed to identify the safest and most effective interventional option for patients.
METHODS
The PEERLESS study (ClinicalTrials.gov identifier: NCT05111613) is a currently enrolling multinational RCT comparing large-bore mechanical thrombectomy (MT) with the FlowTriever System (Inari Medical, Irvine, CA) vs catheter-directed thrombolysis (CDT). A total of 550 hemodynamically stable PE patients with right ventricular (RV) dysfunction and additional clinical risk factors will undergo 1:1 randomization. Up to 150 additional patients with absolute thrombolytic contraindications may be enrolled into a nonrandomized MT cohort for separate analysis. The primary end point will be assessed at hospital discharge or 7 days post procedure, whichever is sooner, and is a composite of the following clinical outcomes constructed as a hierarchal win ratio: (1) all-cause mortality, (2) intracranial hemorrhage, (3) major bleeding, (4) clinical deterioration and/or escalation to bailout, and (5) intensive care unit admission and length of stay. The first 4 components of the win ratio will be adjudicated by a Clinical Events Committee, and all components will be assessed individually as secondary end points. Other key secondary end points include all-cause mortality and readmission within 30 days of procedure and device- and drug-related serious adverse events through the 30-day visit.
IMPLICATIONS
PEERLESS is the first RCT to compare 2 different interventional treatment strategies for hemodynamically stable PE and results will inform strategy selection after the physician or PERT determines advanced therapy is warranted.
Topics: Humans; Thrombolytic Therapy; Treatment Outcome; Pulmonary Embolism; Fibrinolytic Agents; Hemorrhage; Catheters; Thrombectomy
PubMed: 37703948
DOI: 10.1016/j.ahj.2023.09.002 -
Neurosurgery Clinics of North America Jul 2024Dural arteriovenous fistulas are rare cerebrovascular lesions arising from abnormal connections between an artery and a vein. Though rare, high-grade aggressive lesions...
Dural arteriovenous fistulas are rare cerebrovascular lesions arising from abnormal connections between an artery and a vein. Though rare, high-grade aggressive lesions can cause hemorrhagic events and non-hemorrhagic neurologic deficits if left untreated. Treatment options vary based on angioarchitecture, location, and patient characteristics and range from conservative observation to palliative treatment, radiosurgery, endovascular embolization, and open surgery. The main goal of treatment is to obliterate flow through the abnormal connection and prevent further arterial flow to the venous system.
Topics: Humans; Central Nervous System Vascular Malformations; Embolization, Therapeutic; Endovascular Procedures; Neurosurgical Procedures; Radiosurgery
PubMed: 38782526
DOI: 10.1016/j.nec.2024.02.005 -
European Heart Journal Aug 2023The current treatment algorithm for chronic thromboembolic pulmonary hypertension (CTEPH) as depicted in the 2022 European Society of Cardiology (ESC)/European...
Balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension: a clinical consensus statement of the ESC working group on pulmonary circulation and right ventricular function.
The current treatment algorithm for chronic thromboembolic pulmonary hypertension (CTEPH) as depicted in the 2022 European Society of Cardiology (ESC)/European Respiratory Society (ERS) guidelines on the diagnosis and treatment of pulmonary hypertension (PH) includes a multimodal approach of combinations of pulmonary endarterectomy (PEA), balloon pulmonary angioplasty (BPA) and medical therapies to target major vessel pulmonary vascular lesions, and microvasculopathy. Today, BPA of >1700 patients has been reported in the literature from centers in Asia, the US, and also Europe; many more patients have been treated outside literature reports. As BPA becomes part of routine care of patients with CTEPH, benchmarks for safe and effective care delivery become increasingly important. In light of this development, the ESC Working Group on Pulmonary Circulation and Right Ventricular Function has decided to publish a document that helps standardize BPA to meet the need of uniformity in patient selection, procedural planning, technical approach, materials and devices, treatment goals, complications including their management, and patient follow-up, thus complementing the guidelines. Delphi methodology was utilized for statements that were not evidence based. First, an anatomical nomenclature and a description of vascular lesions are provided. Second, treatment goals and definitions of complete BPA are outlined. Third, definitions of complications are presented which may be the basis for a standardized reporting in studies involving BPA. The document is intended to serve as a companion to the official ESC/ERS guidelines.
Topics: Humans; Hypertension, Pulmonary; Pulmonary Embolism; Pulmonary Circulation; Ventricular Function, Right; Angioplasty, Balloon; Pulmonary Artery; Chronic Disease; Cardiology
PubMed: 37470202
DOI: 10.1093/eurheartj/ehad413 -
Emergency Medicine Clinics of North... Aug 2023Best practices in cardiac arrest depend on continuous high-quality chest compressions, appropriate ventilatory management, early defibrillation of shockable rhythms, and... (Review)
Review
Best practices in cardiac arrest depend on continuous high-quality chest compressions, appropriate ventilatory management, early defibrillation of shockable rhythms, and identification and treatment of reversible causes. Although most patients can be treated according to highly vetted treatment guidelines, some special situations in cardiac arrest arise where additional skills and preparation can improve outcomes. Situations covered in this section involve cardiac arrest in context of electrical injuries, asthma, allergic reactions, pregnancy, trauma, electrolyte imbalances, toxic exposures, hypothermia, drowning, pulmonary embolism, and left ventricular assist devices.
Topics: Female; Pregnancy; Humans; Heart Arrest; Asthma; Heart-Assist Devices; Hypersensitivity; Pulmonary Embolism
PubMed: 37391246
DOI: 10.1016/j.emc.2023.05.001 -
Methodist DeBakey Cardiovascular Journal 2024For patients with existing venous thromboembolisms (VTEs), anticoagulation remains the standard of care recommended across multiple professional organizations. However,... (Review)
Review
For patients with existing venous thromboembolisms (VTEs), anticoagulation remains the standard of care recommended across multiple professional organizations. However, for patients who developed a deep venous thrombosis (DVT) and/or a pulmonary embolism and cannot tolerate anticoagulation, inferior vena cava (IVC) filters must be considered among other alternative treatments. Although placement of a filter is considered a low-risk intervention, there are important factors and techniques that surgeons and interventionalists should be aware of and prepared to discuss. This overview covers the basics regarding the history of filters, indications for placement, associated risks, and techniques for difficult removal.
Topics: Vena Cava Filters; Humans; Pulmonary Embolism; Venous Thrombosis; Risk Factors; Device Removal; Prosthesis Implantation; Prosthesis Design; Treatment Outcome; Venous Thromboembolism; Vena Cava, Inferior; Risk Assessment; Anticoagulants
PubMed: 38765211
DOI: 10.14797/mdcvj.1346 -
Current Cardiology Reports Jul 2023The clinical guidelines and current practice in the field of removable cardiovascular pathologies are not aligned and are in fluctuation. The purpose of this review... (Review)
Review
PURPOSE OF REVIEW
The clinical guidelines and current practice in the field of removable cardiovascular pathologies are not aligned and are in fluctuation. The purpose of this review manuscript is to propose adjustments and forecast changes in clinical practice in this field ahead of irrefutable evidence. Percutaneous aspiration devices may be used in case of pulmonary embolism, endocarditis, cardiac thrombi, and tumors. The rationale of treatment includes prevention of emboli, endocarditis debulking and modification, sampling of tissue, and salvage therapy. We are describing the contemporary treatments that are occurring in practice outside and above guidelines.
RECENT FINDINGS
The current standard therapy for the above-mentioned entities is not supported by robust data. Moreover, evidence suggesting priority for the use of percutaneous aspiration devices as first-line therapy-before turning to or in lieu of surgery or thrombolysis-continues to accumulate. However, guidelines still mention percutaneous aspiration only as an alternative to standard treatment. In the current review, we discuss the pathophysiology that supports percutaneous cardiac and pulmonary artery aspiration, the commonly used devices for that purpose, their clinical evidence, and accordingly propose a modified approach to patient management. In addition, this review highlights fluid dynamic principles important in matter extraction in order to better define the utility of catheter-based technologies in different cardiovascular territories. The target diseases encompassed in this review are pulmonary embolism, cardiac masses, and vegetations.
Topics: Humans; Pulmonary Artery; Pulmonary Embolism; Thrombosis; Heart; Endocarditis
PubMed: 37166556
DOI: 10.1007/s11886-023-01891-w -
Stroke May 2024ARISE (Aneurysm/AVM/cSDH Roundtable Discussion With Industry and Stroke Experts) organized a one-and-a-half day meeting and workshop and brought together representatives...
ARISE (Aneurysm/AVM/cSDH Roundtable Discussion With Industry and Stroke Experts) organized a one-and-a-half day meeting and workshop and brought together representatives from academia, industry, and government to discuss the most promising approaches to improve outcomes for patients with chronic subdural hematoma (cSDH). The emerging role of middle meningeal artery embolization in clinical practice and the design of current and potential future trials were the primary focuses of discussion. Existing evidence for imaging, indications, agents, and techniques was reviewed, and areas of priority for study and key questions surrounding the development of new and existing treatments for cSDH were identified. Multiple randomized, controlled trials have met their primary efficacy end points, providing high-level evidence that middle meningeal artery embolization is a potent adjunctive therapy to the standard (surgical and nonsurgical) management of neurologically stable cSDH patients in terms of reducing rates of disease recurrence. Pooled data analyses following the formal conclusion and publication of these trials will form a robust foundation upon which guidelines can be strengthened for cSDH treatment modalities and optimal patient selection, as well as delineate future lines of investigation.
Topics: Humans; Consensus; Embolization, Therapeutic; Hematoma, Subdural, Chronic; Randomized Controlled Trials as Topic
PubMed: 38648281
DOI: 10.1161/STROKEAHA.123.044129 -
Clinical Neurology and Neurosurgery Sep 2023In recent 10 years, Woven EndoBridge(WEB) device has been used as endovascular instrumentation for treating wide neck Bifurcation aneurysms. Its safety and efficacy in... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
In recent 10 years, Woven EndoBridge(WEB) device has been used as endovascular instrumentation for treating wide neck Bifurcation aneurysms. Its safety and efficacy in the mid-term (6-24 months) and long-term (more than 24 months) follow-up period have yet to be systematically reviewed.
PURPOSE
To evaluate the WEB device safety and efficacy, relevant literature and publications were extensively reviewed, and a meta-analysis was conducted.
DATA RESOURCE
All relevant literature/publications were achieved from Pubmed, Cochrane, Embase, and Web of Science databases.
RESULTS
767 patients that were studied in 13 literature were included. The focus of this review was placed on the clinical and anatomic outcomes. Complete occlusion was achieved in 67.3% (95% CI, 59.0-75.5%) and 69.3% (95% CI, 55.7-82.8%) of the cases at mid- and long-term follow-up. The rate of adequate occlusion was 86.6% (95% CI, 83.0-90.2%) and 90.1% (95% CI, 85.5-94.4%) for the mid and long-term, respectively. 51 patients (8.8%; 95% CI,5.6-11.9%) and 18 (8.1%; 95% CI,0.8-15.5%) received retreatments during mid- and long-term follow-up, respectively. 410 patients from 427 (94.3%; 95% CI, 89.7-98.9%) showed favorable clinical outcomes. The all-cause mortality rate was 3.5% (95% CI, 1.4-5.6%), where only a few cases were related to the WEB implantation. The WEB device deployment was associated with an overall clinical complication rate of 4.1% (95% CI, 2.7-6.6%), 3 hemorrhagic (1.2%; 95% CI, 0.2-2.6%), and 30 thromboembolic (4.0%; 95% CI, 4.0- 6.0%) complications.
CONCLUSIONS
The findings reveal the satisfactory safety and effectiveness of the WEB device for the Treatment of wide-neck aneurysms during mid-to-long-term follow-up, indicating the high potential of the WEB device for wide application.
Topics: Humans; Treatment Outcome; Embolization, Therapeutic; Endovascular Procedures; Intracranial Aneurysm; Thromboembolism; Retrospective Studies
PubMed: 37423087
DOI: 10.1016/j.clineuro.2023.107861