FDA Recognizes SeaStar Medical’s SCD as Breakthrough Device for Managing Systemic Inflammation
In April 2025, the FDA granted Breakthrough Device designation to SeaStar Medical’s Selective Cytopheretic Device (SCD), recognizing its potential to address a critical unmet need in post-cardiac surgery care. The SCD is designed to manage systemic inflammatory response syndrome (SIRS), a potentially life-threatening complication that can occur following major cardiac procedures. This breakthrough status highlights…
Read
Outcomes and Mortality Predictors in Postcardiotomy ECMO for Patients Aged 70 and Above
A retrospective study by Maged Makhoul and colleagues, published in JTCVS Open, examined the outcomes of postcardiotomy extracorporeal membrane oxygenation (PC-ECMO) in older patients aged 70 years and above compared with younger patients. The analysis included 2057 patients treated between 2000 and 2020, of whom 33% were aged 70 or older. Results demonstrated that older…
Read
Prophylactic Amiodarone Reduces Ventricular Fibrillation in LVH Patients Undergoing Open-Heart Surgery
In a comprehensive randomized controlled trial conducted by Chan-Juan Gong and colleagues, the researchers rigorously evaluated the effectiveness of prophylactic intravenous amiodarone in reducing the incidence of ventricular fibrillation (VF) post-aortic cross-clamp (ACC) removal in patients with left ventricular hypertrophy (LVH) undergoing open-heart surgery. The study involved 54 patients who were randomly assigned to one…
Read
BiVACOR’s Total Artificial Heart Earns FDA Breakthrough Status
On June 2, 2025, the FDA granted Breakthrough Device status to the BiVACOR Total Artificial Heart (TAH)—a next-generation fully implantable heart replacement system. What sets BiVACOR apart is its magnetically levitated pump, which allows for precise, continuous blood flow without the need for valves or diaphragms. The compact design is intended to serve as a…
Read
Ethical Challenges of NRP in Circulatory Death A 2025 Scoping Review
A 2025 scoping review titled “Ethical Issues in Normothermic Regional Perfusion in Controlled Organ Donation After Determination of Death by Circulatory Criteria” by Manara et al., published in Transplantation, offers a comprehensive evaluation of the ethical concerns surrounding Normothermic Regional Perfusion (NRP) in the context of controlled donation after circulatory determination of death (cDCDD). The…
Read
Impact of ECMO and CRRT Circuits on Ketamine and Dexmedetomidine Levels: Adjusting Sedative Dosing in ECLS-Supported Patients
The study by Andrew Chevalier and colleagues, published in the Journal of Extracorporeal Technology, investigates how extracorporeal life support (ECLS) circuits, specifically ECMO (extracorporeal membrane oxygenation) and CRRT (continuous renal replacement therapy), affect the pharmacokinetics of sedatives ketamine and dexmedetomidine. These medications are commonly administered to patients on ECLS for pain and sedation management. ECLS…
Read
Utilizing NIRS and Vascular Occlusion Test (VOT) to Predict Acute Kidney Injury (AKI): The Significance of Desaturation Speed (D-speed) in Cardiac Surgery Patients
The study by Ling Peng et al., published in the Journal of Cardiothoracic Surgery, investigates the effectiveness of Near-Infrared Spectroscopy (NIRS) combined with the Vascular Occlusion Test (VOT) in predicting acute kidney injury (AKI) in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). NIRS allows for non-invasive measurement of tissue oxygen saturation (StO2). At the…
Read
OPO-Led Normothermic Regional Perfusion Enhances Organ Recovery and Transplant Outcomes
A 2025 study evaluating outcomes of 90 non-thoracic donors managed with Organ Procurement Organization (OPO)-based Normothermic Regional Perfusion (NRP) demonstrated significant advancements in organ recovery effectiveness. The research revealed a substantial improvement in liver utilization rates, increasing steadily from 53% to 83% across three defined operational periods. This trend highlights the increasing efficiency and acceptance…
Read
Reversing Heart Damage: How α-Lipoic Acid Targets Senescent Macrophages in Myocardial Infarction
The study titled “α-Lipoic acid alleviates myocardial infarction by suppressing age-independent macrophage senescence” by Yuchao Wang et al., published in Scientific Reports, investigates the therapeutic role of α-Lipoic acid (ALA) in myocardial infarction (MI) through the modulation of macrophage senescence. MI remains a leading cause of morbidity and mortality worldwide, and the senescence-associated secretory phenotype…
Read
A Wearable Lifeline: FDA Clears Jewel Patch Defibrillator for At-Risk Patients
The U.S. Food and Drug Administration (FDA) has approved the Jewel® Patch Wearable Cardioverter Defibrillator (Patch-WCD), developed by Element Science. This next-generation wearable defibrillator is specifically designed for adults at risk of sudden cardiac arrest who either aren’t eligible for or choose not to receive a traditional implantable defibrillator. Its patch-based form factor provides continuous…
Read
Predicting Pulmonary Edema Risks in Cardiac Surgery: The Role of Lung Compliance and Airway Resistance
The article: “Predictive value of respiratory mechanics for the risk of unilateral pulmonary edema following minimally invasive cardiac surgery: An observational study” by Qiaolian Fan, published in Medicine, investigates the predictive value of static lung compliance (SLC) and airway resistance (AR) for anticipating unilateral pulmonary edema (UPE) in patients undergoing minimally invasive cardiac surgery (MICS)….
Read
The Rising Price of a Failing Heart Global HF Costs Near $300 Billion
A systematic review published in the European Heart Journal in May 2025 provides an in-depth analysis of the global economic burden of heart failure (HF), estimating total annual costs at $284.17 billion. This figure includes $136.86 billion in direct healthcare costs, representing nearly 48% of the total burden, while indirect costs account for the remaining…
Read