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JAMA Dec 2023Left ventricular assist devices (LVADs) enhance quality and duration of life in advanced heart failure. The burden of nonsurgical bleeding events is a leading morbidity....
IMPORTANCE
Left ventricular assist devices (LVADs) enhance quality and duration of life in advanced heart failure. The burden of nonsurgical bleeding events is a leading morbidity. Aspirin as an antiplatelet agent is mandated along with vitamin K antagonists (VKAs) with continuous-flow LVADs without conclusive evidence of efficacy and safety.
OBJECTIVE
To determine whether excluding aspirin as part of the antithrombotic regimen with a fully magnetically levitated LVAD is safe and decreases bleeding.
DESIGN, SETTING, AND PARTICIPANTS
This international, randomized, double-blind, placebo-controlled study of aspirin (100 mg/d) vs placebo with VKA therapy in patients with advanced heart failure with an LVAD was conducted across 51 centers with expertise in treating patients with advanced heart failure across 9 countries. The randomized population included 628 patients with advanced heart failure implanted with a fully magnetically levitated LVAD (314 in the placebo group and 314 in the aspirin group), of whom 296 patients in the placebo group and 293 in the aspirin group were in the primary analysis population, which informed the primary end point analysis. The study enrolled patients from July 2020 to September 2022; median follow-up was 14 months.
INTERVENTION
Patients were randomized in a 1:1 ratio to receive aspirin (100 mg/d) or placebo in addition to an antithrombotic regimen.
MAIN OUTCOMES AND MEASURES
The composite primary end point, assessed for noninferiority (-10% margin) of placebo, was survival free of a major nonsurgical (>14 days after implant) hemocompatibility-related adverse events (including stroke, pump thrombosis, major bleeding, or arterial peripheral thromboembolism) at 12 months. The principal secondary end point was nonsurgical bleeding events.
RESULTS
Of the 589 analyzed patients, 77% were men; one-third were Black and 61% were White. More patients were alive and free of hemocompatibility events at 12 months in the placebo group (74%) vs those taking aspirin (68%). Noninferiority of placebo was demonstrated (absolute between-group difference, 6.0% improvement in event-free survival with placebo [lower 1-sided 97.5% CI, -1.6%]; Pā<ā.001). Aspirin avoidance was associated with reduced nonsurgical bleeding events (relative risk, 0.66 [95% confidence limit, 0.51-0.85]; Pā=ā.002) with no increase in stroke or other thromboembolic events, a finding consistent among diverse subgroups of patient characteristics.
CONCLUSIONS AND RELEVANCE
In patients with advanced heart failure treated with a fully magnetically levitated LVAD, avoidance of aspirin as part of an antithrombotic regimen, which includes VKA, is not inferior to a regimen containing aspirin, does not increase thromboembolism risk, and is associated with a reduction in bleeding events.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04069156.
Topics: Male; Humans; Female; Aspirin; Heart-Assist Devices; Fibrinolytic Agents; Double-Blind Method; Heart Failure; Stroke; Platelet Aggregation Inhibitors; Hemorrhage; Thromboembolism
PubMed: 37950897
DOI: 10.1001/jama.2023.23204 -
European Heart Journal Feb 2024The role of cardiac implantable electronic device (CIED)-related tricuspid regurgitation (TR) is increasingly recognized as an independent clinical entity. Hence,... (Review)
Review
The role of cardiac implantable electronic device (CIED)-related tricuspid regurgitation (TR) is increasingly recognized as an independent clinical entity. Hence, interventional TR treatment options continuously evolve, surgical risk assessment and peri-operative care improve the management of CIED-related TR, and the role of lead extraction is of high interest. Furthermore, novel surgical and interventional tricuspid valve treatment options are increasingly applied to patients suffering from TR associated with or related to CIEDs. This multidisciplinary review article developed with electrophysiologists, interventional cardiologists, imaging specialists, and cardiac surgeons aims to give an overview of the mechanisms of disease, diagnostics, and proposes treatment algorithms of patients suffering from TR associated with CIED lead(s) or leadless pacemakers.
Topics: Humans; Pacemaker, Artificial; Defibrillators, Implantable; Tricuspid Valve; Tricuspid Valve Insufficiency; Rheumatic Heart Disease; Retrospective Studies
PubMed: 38096587
DOI: 10.1093/eurheartj/ehad783 -
Deutsches Arzteblatt International Oct 2023In Germany, a total of 38 547 heart valve procedures were performed in 2022. With a growing number of patients undergoing the surgical and interventional implantation of... (Review)
Review
BACKGROUND
In Germany, a total of 38 547 heart valve procedures were performed in 2022. With a growing number of patients undergoing the surgical and interventional implantation of heart valves, the incidence of prosthetic endocarditis is also rising.
METHODS
We summarize the current state of the prophylaxis, diagnosis, and treatment of prosthetic endocarditis in a selective review of the literature.
RESULTS
Prosthetic endocarditis accounts for 10-30% of all cases of endocarditis. As its echocardiographic and microbiologic findings are often less specific than those of native endocarditis, its diagnosis now increasingly relies on alternative imaging modalities such as F-18-FDG PET-CT. Anti-infective and surgical treatment are made more difficult by biofilm formation on the prosthetic valve and the frequent formation of perivalvular abscesses.
CONCLUSION
Increased awareness of this clinical entity in the outpatient setting will promote the earlier initiation of appropriate diagnostic studies. Proper diagnostic evaluation is an essential prerequisite for the early detection and timely treatment of prosthetic endocarditis, with the goal of preventing progressive destruction and thus improving the outcome. Preventive and educative measures should be intensified, and certified, multidisciplinary endocarditis teams should be established. Antibiotic prophylaxis is now given much more restrictively than in earlier years; the risk of infection must be weighed against the potential development of both individual and collective resistance to antibiotic drugs.
Topics: Humans; Positron Emission Tomography Computed Tomography; Fluorodeoxyglucose F18; Heart Valve Prosthesis; Endocarditis; Heart, Artificial
PubMed: 37427994
DOI: 10.3238/arztebl.m2023.0104 -
Advanced Drug Delivery Reviews Oct 2023The use of cardiovascular implants is commonplace in clinical practice. However, reproducing the key bioactive and adaptive properties of native cardiovascular tissues... (Review)
Review
The use of cardiovascular implants is commonplace in clinical practice. However, reproducing the key bioactive and adaptive properties of native cardiovascular tissues with an artificial replacement is highly challenging. Exciting new treatment strategies are under development to regenerate (parts of) cardiovascular tissues directly in situ using immunomodulatory biomaterials. Direct exposure to the bloodstream and hemodynamic loads is a particular challenge, given the risk of thrombosis and adverse remodeling that it brings. However, the blood is also a source of (immune) cells and proteins that dominantly contribute to functional tissue regeneration. This review explores the potential of the blood as a source for the complete or partial in situ regeneration of cardiovascular tissues, with a particular focus on the endothelium, being the natural blood-tissue barrier. We pinpoint the current scientific challenges to enable rational engineering and testing of blood-contacting implants to leverage the regenerative potential of the blood.
Topics: Humans; Biocompatible Materials; Cardiovascular System; Prostheses and Implants; Tissue Engineering
PubMed: 37690484
DOI: 10.1016/j.addr.2023.115085 -
International Journal of Medical... Aug 2023As diagnostic and prognostic models developed by traditional statistics perform poorly in real-world, artificial intelligence (AI) and Big Data (BD) may improve the... (Review)
Review
BACKGROUND
As diagnostic and prognostic models developed by traditional statistics perform poorly in real-world, artificial intelligence (AI) and Big Data (BD) may improve the supply chain of heart transplantation (HTx), allocation opportunities, correct treatments, and finally optimize HTx outcome. We explored available studies, and discussed opportunities and limits of medical application of AI to the field of HTx.
METHOD
A systematic overview of studies published up to December 31st, 2022, in English on peer-revied journals, have been identified through PUBMED-MEDLINE-WEB of Science, referring to HTx, AI, BD. Studies were grouped in 4 domains based on main studies' objectives and results: etiology, diagnosis, prognosis, treatment. A systematic attempt was made to evaluate studies by the Prediction model Risk Of Bias ASsessment Tool (PROBAST) and the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD).
RESULTS
Among the 27 publications selected, none used AI applied to BD. Of the selected studies, 4 fell in the domain of etiology, 6 in the domain of diagnosis, 3 in the domain of treatment, and 17 in that of prognosis, as AI was most frequently used for algorithmic prediction and discrimination of survival, but in retrospective cohorts and registries. AI-based algorithms appeared superior to probabilistic functions to predict patterns, but external validation was rarely employed. Indeed, based on PROBAST, selected studies showed, to some extent, significant risk of bias (especially in the domain of predictors and analysis). In addition, as example of applicability in the real-world, a free-use prediction algorithm developed through AI failed to predict 1-year mortality post-HTx in cases from our center.
CONCLUSIONS
While AI-based prognostic and diagnostic functions performed better than those developed by traditional statistics, risk of bias, lack of external validation, and relatively poor applicability, may affect AI-based tools. More unbiased research with high quality BD meant for AI, transparency and external validations, are needed to have medical AI as a systematic aid to clinical decision making in HTx.
Topics: Humans; Artificial Intelligence; Big Data; Heart Transplantation; Prognosis; Retrospective Studies
PubMed: 37285695
DOI: 10.1016/j.ijmedinf.2023.105110 -
Annual Review of Medicine Jan 2024Cardiac pacing to treat bradyarrhythmias has evolved in recent decades. Recognition that a substantial proportion of pacemaker-dependent patients can develop heart... (Review)
Review
Cardiac pacing to treat bradyarrhythmias has evolved in recent decades. Recognition that a substantial proportion of pacemaker-dependent patients can develop heart failure due to electrical and mechanical dyssynchrony from traditional right ventricular apical pacing has led to development of more physiologic pacing methods that better mimic normal cardiac conduction and provide synchronized ventricular contraction. Conventional biventricular pacing has been shown to benefit patients with heart failure and conduction system disease but can be limited by scarring and fibrosis. His bundle pacing and left bundle branch area pacing are novel techniques that can provide more physiologic ventricular activation as an alternative to conventional or biventricular pacing. Leadless pacing has emerged as another alternative pacing technique to overcome limitations in conventional transvenous pacemaker systems. Our objective is to review the evolution of cardiac pacing and explore these new advances in pacing strategies.
Topics: Humans; Bundle-Branch Block; Cardiac Resynchronization Therapy; Pacemaker, Artificial; Heart Ventricles; Heart Failure; Treatment Outcome
PubMed: 37989145
DOI: 10.1146/annurev-med-051022-042616 -
Bioengineering (Basel, Switzerland) Sep 2023Transplant pathology plays a critical role in ensuring that transplanted organs function properly and the immune systems of the recipients do not reject them. To improve... (Review)
Review
Transplant pathology plays a critical role in ensuring that transplanted organs function properly and the immune systems of the recipients do not reject them. To improve outcomes for transplant recipients, accurate diagnosis and timely treatment are essential. Recent advances in artificial intelligence (AI)-empowered digital pathology could help monitor allograft rejection and weaning of immunosuppressive drugs. To explore the role of AI in transplant pathology, we conducted a systematic search of electronic databases from January 2010 to April 2023. The PRISMA checklist was used as a guide for screening article titles, abstracts, and full texts, and we selected articles that met our inclusion criteria. Through this search, we identified 68 articles from multiple databases. After careful screening, only 14 articles were included based on title and abstract. Our review focuses on the AI approaches applied to four transplant organs: heart, lungs, liver, and kidneys. Specifically, we found that several deep learning-based AI models have been developed to analyze digital pathology slides of biopsy specimens from transplant organs. The use of AI models could improve clinicians' decision-making capabilities and reduce diagnostic variability. In conclusion, our review highlights the advancements and limitations of AI in transplant pathology. We believe that these AI technologies have the potential to significantly improve transplant outcomes and pave the way for future advancements in this field.
PubMed: 37760142
DOI: 10.3390/bioengineering10091041