My Life at 9200 rpm's: Welcome HeartWare

This week the U.S.  Food and Drug Administration gave approval to an LVAD that is smaller than mine.  It is made by HeartWare of Framingham, MA.  It has been a head on competitor of Thoratec's HeartMate II, which received approval as both a destination (read permanent) and bridge to transplant device by the FDA in early 2010.

In my view, the competition is healthy.  You cannot have too many lifesaving devices out there for those who have end stage congestive heart failure.  

With the approval as a bridge to transplant, HeartWare is seeking approval as a destination therapy device. Undoubtedly, it will succeed.  Here is a link to one account of the approval:  http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/36041

The American Heart Association estimates that there are more than 5 million Americans with congestive heart failure, a figure that grows by about 600,000 per year.  Because of other medical issues the number who can receive LVAD implants is quite small.

In the past few years, the HeartMate II has been implanted in more than 10,000 patients worldwide. Mine is number 8358, and it was implanted in April 2010.  The 10,000th HeartMate II was implanted this year. That computes to 750 to 1,000 of Thoratec's LVAD being implanted yearly.  Compare that multi-year total with the estimated 600,000 new CHF sufferers added to the ranks and you can see how few LVADs there are.  Hence, welcome HeartWare's HVAD.

HeartWare's pump is smaller than the HeartMate II. The external gear, computer controller and batteries, are smaller and lighter weight.  The set up makes an LVAD accessible to smaller sized adults and children.  

The HeartWare pump is called an HVAD.  It is based on a centrifugal force to pump blood to assist the CHF sufferer's inefficient left ventricle.  The HVAD is shown as being attached to the lower side of the left ventricle. 

 Like the HeartMate II, the HVAD system has a percutaneous lead that exists the abdomen of the patient to connect with the external controller and power source.

The HVAD batteries are worn in pairs but the system apparently works on one battery at a time and the system shifts to the spare battery after about six hours.  The spent battery must then be changed out.

The HeartMate II is a continuous flow, non-pulsatile device.  Mine is set at 9200 rpm's.  Other HM II's go slower and faster as determined by the LVAD team.  It runs on two 12 hour batteries at a time.  The controller and external batteries are weightier than the HVAD's.

Having more approved ventricular assist devices available in the medical marketplace is a good thing.  More options.

If you suffer from end stage congestive heart failure and are otherwise healthy enough to tolerate the surgery, get the facts from a VAD center physician.  

From my experience, not every cardiologist is knowledgeable about LVADs, their benefits and drawbacks.  But at a VAD center,  like the University of Minnesota Hospital, Mayo Clinic, or Abbott-Northwestern in Minneapolis they do. Don't delay.  Get an assessment of the potential for LVAD implantation.  

The life you save, may be your own.