August 04, 2020
The U.S. Food and Drug Administration has approved an experimental treatment that saved the life of a Philadelphia warehouse worker who developed severe COVID-19 complications.
Devan Smith, 42, is among three Pennsylvania patients who overcame the coronavirus when doctors used the Impella heart pump in conjunction with an extracorporeal membrane oxygenation machine.
COVID-19 is known to cause widespread inflammation throughout the body, including the heart, as well as causing fluid buildup in the lungs. The combination of heart and lung failure in COVID-19 patients is rare, but it can be life-threatening.
The dual treatment of the Impella heart pump and an ECMO machine allows the inflamed heart muscle to rest while more oxygen is pumped into the bloodstream.
Smith was treated for COVID-19 at Mercy Catholic Medical Center in Darby, Delaware County. He was on a ventilator when his heart began to fail.
"This wasn't a heart attack in the traditional sense. It was a pure case of myocarditis," Mercy Catholic cardiologist Dr. John Finley told CNBC. "No sooner than we'd get him back to the ICU that he arrested probably 10 to 15 times."
That's when doctors decided to try the Impella heart pump with an ECMO machine. Smith was off the machines five days later. Within a few weeks, he had fully recovered – with no heart damage.
"I'm so thankful for the physicians, nurses and staff who saved my life," Smith said in a statement. "My recovery was made possible by their use of life-saving therapies like Impella and ECMO, that allowed my body to overcome COVID-19."
The Impella heart pump has since received emergency use approval to treat COVID-19 patients battling heart and lung failure, Abiomed, the heart pump's manufacturer, announced Tuesday. The pump must be used alongside an ECMO machine.
The FDA also based its approval on several studies published in recent years in medical journals like the European Journal of Heart Failure and the Journal of the American College of Cardiology.
Over the last decade, about 10,000 ECMO patients in cardiogenic shock – a condition that occurs when the heart suddenly can't pump enough blood to the rest of the body – have been given left ventricular support from the Impella.
"The early clinical evidence continues to accrue in favor of including left ventricular unloading in many patients on ECMO," said Dr. Christian Bermudez, surgical director of lung transplantation and ECMO at the University of Pennsylvania.
"The superior clinical outcomes of the combination of Impella and ECMO are likely the result of reducing the stress on the myocardium and work required of the left ventricle, also reducing secondary lung injury due to pulmonary congestion."
This marks the second emergency use authorization for the Impella heart pump. In late May, it was approved to stabilize COVID-19 patients who had pulmonary blood clots removed.
The Impella heart pump first received FDA clearance in 2008 and FDA pre-market approval as safe and effective in 2015.