HeartWare® ventricular assist system meets non-inferiority goal
MedWire News: Success rates with HeartWare®, a continuous-flow left ventricular assist device for the treatment of patients with advanced heart failure, are comparable to those of commercially available devices, findings from the ADVANCE trial show.
The study findings reveal that more than 90% of patients with New York Heart Association (NYHA) class IV heart failure who received the device survived on the device or to transplant or explant for ventricular recovery for at least 180 days.
For the non-randomized trial, 137 patients aged >18 years with NYHA class IV heart failure, who were listed for cardiac transplantation and had a United Network for Organ Sharing (UNOS) status of IA or IB received the HeartWare® (HeartWare International, Inc., Framingham, MA) device.
The outcome of these patients was then compared with that of 499 control patients in the INTERagency registry for Mechanical Assisted Circulatory Support (INTERMACS) who were enrolled contemporaneously and who received a commercially available primary left ventricular assist device (LVAD).
The primary outcome of success - defined as survival on the originally implanted device, transplant, or device explantation for ventricular recovery at 180 days - occurred in 92.0% of patients in the treatment group and in 90.1% of controls. The device met the pre-specified goal of non-inferiority, with a 95% upper confidence limit for the difference of 0.9% (p<0.001).
The device could not be shown to be superior to comparator devices, however.
Adverse events included bleeding requiring surgery in 15.0%, local infections in 24.3%, driveline exit infections in 10.7%, sepsis in 6.4%, ischemic stroke in 10, hemorrhagic stroke in 2.9%, and transient ischemic attack in 5%.
In an analysis of 79 patients on the device, there were significant increases from baseline to 3 months in quality-of-life scores and 6-minute walking distance (p for all comparison, <0.001).
Presenting the findings at the American Heart Association Scientific Sessions in Chicago, Illinois, USA, primary investigator Keith Aaronson (University of Michigan, Division of Cardiovascular Medicine, Ann Arbor, USA), said: "The success rate with this novel device was quite high, survival was quite good, there was a favorable adverse event profile and marked improvements in functional-class quality of life, with improvements in quality of life similar to what we see with cardiac transplantation."
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By Neil Osterweil