–LVAD deactivation is not euthanasia or physician-assisted suicide. Left ventricular assist devices (LVADs) are used increasingly as destination therapy instead of as a temporary bridge until a donor heart becomes available for transplantation. Now patients, their families, and their caregivers are forced to confront the extremely difficult question of when and how to turn off…
LVADs Prolong Life But Sow Confusion
March 22, 2016 by Leave a Comment
–Patients with LVADs and their caregivers suffer from confusion and uncertainty at the end of life. More and more people with advanced heart failure are receiving left ventricular assist devices (LVADs) as destination therapy. Now clinicians who treat these patients are reporting that the patients and their caregivers are suffering from an extraordinary amount of…
4 Deaths Linked To Thoratec Heart System
March 4, 2014 by Leave a Comment
Thoratec Corporation today issued an urgent safety advisory about a serious problem with a key component of the HeartMate II LVAS system. The company said 4 patients had died and 5 patients had a loss of consciousness or other symptoms of hypoperfusion. The episodes occurred when patients and caregivers “experienced difficulties with the process of changing from a primary…
Physicians Report Alarming Increase In LVAD Pump Thrombosis
November 27, 2013 by Leave a Comment
Physicians from three top institutions report an abrupt and highly troubling increase over the last two years in the incidence of pump thrombosis in patients who have received the HeartMate II left ventricular assist device (LVAD) manufactured by Thoractec. The current investigation, published online in the New England Journal of Medicine, was initially prompted by an observed increase in…
HeartWare LVAD Approved By FDA For Transplant Patients
November 20, 2012 by Leave a Comment
The FDA said today that it had granted approval to the HeartWare Ventricular Assist System for use in heart failure patients waiting for a transplant. Approval of the device had been expected after the FDA’s Circulatory System Devices panel recommended approval of the device earlier this year. HeartWare was approved based on data from the pivotal…
FDA Advisory Panel Gives Green Light To HeartWare Ventricular Assist System
April 25, 2012 by Leave a Comment
The FDA’s Circulatory System Devices panel voted 9-2 on Wednesday to recommend approval of the HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure. The panel agreed unanimously (11-0) that the new device is effective. The panel was more divided about safety but ultimately voted 8-3 that the device…
Recent Comments