Strokes remain a leading cause of morbidity and mortality in patients with ventricular assist devices (VADs). Varying study populations, event definitions, and reporting methods make direct comparison of neurologic event risk across clinical trials and registries challenging. We aim to highlight important differences among major VAD studies and standardize rates of neurologic events to facilitate a comprehensive and objective comparison.
View Article and Find Full Text PDFWe discuss the ethical responsibilities of mechanical circulatory support (MCS) programs in the context of cardiac device recalls, particularly the near-simultaneous recalls of Abbott HeartMate 3 left ventricular assist device (VAD) and Medtronic HVAD devices in 2018. We consider MCS programs' ethical responsibilities toward patients who already have VADs and their caregivers, as well as the impact of recalls on informed consent and shared decision-making in patients under consideration for new VADs. Timely communication to affected patients is imperative throughout the recall process.
View Article and Find Full Text PDFIt is estimated that nearly 6.5 million Americans over the age of 20 suffer from heart failure. Heart failure is the leading cause of hospitalization in patients over 65 years of age, and carries with it a 5-year mortality of nearly 50%.
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