Benefits and Risks

Benefits

The potential benefits of the AbioCor are specific to each individual. Some patients benefit from knowing that some form of treatment is possible when transplantation is not an option. Some patients will be able to go home and have a respectable quality of life with their loved ones. Others, however, may have an extended and difficult recovery.

From the initial clinical trial, we know that each patient’s recovery is different and that each patient chose to receive the AbioCor for different reasons. Some chose the AbioCor for the additional time with family and friends despite a recovery course that could confine them to the hospital and put them at risk of suffering a bleeding event or a neurological event, such as a stroke.

Although results will vary, the AbioCor System potentially offers some of the following benefits:
  • Increase in life expectancy.
    Patients who receive the AbioCor have end-stage heart failure and are at imminent risk of death. The AbioCor may prolong life, however, it is difficult to know for how long compared to what would have happened without the device.
  • Lower risk of infection.
    The AbioCor System is totally implantable. As a result, there may be a lower risk of infection compared to other devices that penetrate the surface of the skin.
  • Improved quality of life.
    A patient’s quality of life during the time he is supported by the AbioCor System may be better than the quality of life that the patient may receive with conventional medical therapy. However, quality of life could also be worse than before the AbioCor was implanted.
  • Extended time with family and friends.
    By extending life, the AbioCor may provide patients with valuable time with family and friends. Some patients see this additional time as time to “put affairs in order".
  • Patient autonomy.
    Patients may benefit from knowing that they have some decision-making ability or some control over their final treatment choices. They may find some satisfaction in having their decision honored and by knowing that all treatment options have been explored.
Benefits Specific to the AbioCor Replacement Heart System:
  • No wires cross the skin
  • Quiet operation
  • Easy to operate
  • Mobile
  • No restrictions on showering or bathing
Risks

As with any major surgery, there are risks associated with receiving the AbioCor System. In addition, because of the severity of your illness, your risks may be higher than others who undergo open-heart surgery.

Below are some of the risks that were identified in the initial AbioCor clinical trial:
  • Death
  • Infections
  • Abdominal discomfort
  • Bleeding
  • Kidney failure
  • Anemia (decreased red blood cells)
  • Stroke
  • Liver failure
  • Injury to soft tissue
  • Esophagus obstruction
  • Device failure
  • Inability to close the chest
  • Impaired breathing
  • Repeat surgeries to replace parts
  • Restrictions on lifestyle and employment
  • Attention to charging batteries and obeying warnings