View on The NewsEarly Results Suggest Adverse-Event Edge for...

View on The News
Early Results Suggest Adverse-Event Edge for HeartWare VAD

The early results from using the HeartWare device as a bridge to transplant are at least as good as those of the other LVADs currently available. The main problem that had dogged the application of LVADs has been their adverse effects. The new VAD appears to cause less infection, probably because it is smaller and needs less dissection during implantation than do current devices. Placement and use of the new HeartWare device may also be associated with less bleeding.

The new device is extremely attractive because it is small and simple to place, and has no need for a pocket. There is hope that these factors will translate into improved clinical benefit.

My major concerns about the current report are that it involved no randomization and no true control group. In addition, the HeartWare device was linked with a significant number of strokes. (There has been hope that the innovative design of this new device might reduce blood thrombogenicity.) In the device?s defense, many of the strokes occurred within the first 48 hours after implant, and up to 80% were recoverable. This issue may also relate to the type of anticoagulation used.

Overall, this study represents a landmark in the long road of optimizing the use of LVADs. I look forward to seeing longer-term results.


Dr. Magdi H. Yacoub is a professor of cardiothoracic surgery at Imperial College London. He said he had no disclosures.