New Study Delays Clinical Trial of Heart Device

For critically ill patients, the chance to test a new medical device could be a lifesaver — or not. Recently, the start of a clinical trial to evaluate a device for use in heart patients was stalled when a study questioned whether it caused more harm than good. medical 

For heart patients suffering a decline in mobility and health as the efficiency of their heart diminished, a clinical trial involving 18 hospitals was planned to test a new heart pump called the Heart Mate II. The pump is the last effort preceding heart transplant or death for those with end-stage heart disease. 

For patients who are not yet terminal, clinicians wonder if the Heart Mate II is a better option than drug regimens. If the device proves effective, these patients could benefit from increased mobility. But it is apparently not safe. According to a recent study published in the New England Journal of Medicine, researchers investigating the device reported the following: 

  • Use of the device causes an increase in blood clots in patients with heart failure. It is unclear whether the clots are caused by the device or medication used in conjunction with the device.
  • The incidence of blood clots, called pump thromboses, increased from 2.5 percent in 2011 to 8.4 percent by 2013.
  • The average length of time from device implantation and development of thromboses is approximately 18 months.
  • The blood clots led to emergency surgery to replace the pump, a heart transplant or death. 

For now, the start of the clinical trial is delayed pending a decision by the National Heart, Lung and Blood Institute. Because of the new study, several research hospitals have declined to participate in the clinical trial. 

When they work, medical devices save lives and assist the medical community in innumerable ways. But if you were injured by a medical device that did not work properly, seek reputable legal advice in North Carolina.

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