Posts Tagged ‘LVAD’

July 10th, 2014

Behind the Patient Decision-Making Process for a Destination-Therapy LVAD

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Colleen K. McIlvennan, Larry A. Allen, and Daniel D. Matlock discuss their study of how patients choose whether to get a left ventricular assist device as destination therapy.

March 5th, 2014

4 Deaths Linked to Thoratec HeartMate II LVAS

Thoratec Corporation on Tuesday issued an urgent safety advisory about a serious problem with a key component of the HeartMate II LVAS system. The company said four patients had died and five 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 […]

November 27th, 2013

Physicians Report Alarming Increase in LVAD Pump Thrombosis

Cardiac 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 Thoratec. The current investigation, published online in the New England Journal of Medicine, was initially prompted by an observed […]

November 21st, 2012

HeartWare LVAD Approved By FDA For Transplant Patients

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 ADVANCE trial, in which 140 […]

September 7th, 2012

News Briefs: Cholesterol Trends, AHA Late-Breakers, FDA Updates On Rivaroxaban And Heartware HVAD

Cholesterol Trends The Centers for Disease Control issued a new report with the latest details about the prevalence of cholesterol screening and high blood cholesterol in U.S. adults. Here is their summary of the key findings: …cholesterol screening increased from 72.7% in 2005 to 76.0% in 2009, whereas the percentage of those screened who reported being told […]

April 26th, 2012

Frailty Evaluation and High-Risk Interventions

When taking care of older patients, we often have an intuitive sense of which ones will do well after an intervention and which ones won’t. This has been termed the “foot of the bed” test, or alternately something which separates a “young 80-year old” from an “old 80-year old.”  Frailty is a syndrome defined as […]

April 26th, 2012

FDA Advisory Panel Gives Green Light to HeartWare Ventricular Assist System

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 […]

November 14th, 2010

New LVAD Shows Promise as Bridge-to-Transplant

ADVANCE (Evaluation of the HeartWare HVAD Left Ventricular Assist Device System for the Treatment of Advanced Heart Failure) evaluated the clinical efficacy of a novel small centrifugal flow pump as a bridge-to-transplant. In the trial, 140 patients who received the device were compared to a contemporaneous control group of 499 similar patients who had received a commercially […]