FDA approves Abiomed Impella heart pump to treat Covid-19 patients

image source

The Food and Drug Administration has approved the Abiomed Impella heart pump for emergency use in treating Covid-19 patients suffering from heart and lung failure.

Data showed that the coronavirus has led to extreme inflammation of the heart in 1 in 10 patients. They also experience a build-up of fluid in the lungs. A 42-year-old patient named Devan Smith had no history of heart disease, and the combination proved nearly fatal in May.

ADVERTISEMENT

“This wasn’t a heart attack in the traditional sense. It was a pure case of myocarditis,” or inflammation of the heart muscle, said Dr. John Finley, a cardiologist at Mercy Catholic Medical Center outside Philadelphia. “No sooner than we’d get him back to the ICU, that he arrested probably 10 to 15 times.”

Doctors at Mercy first placed Smith on a ventilator, but when his heart started to fail, they tried applying Abiomed’s Impella heart pump to give his heart muscle a rest. They also used an extracorporeal membrane oxygenation machine to infuse more oxygen into his bloodstream. It is considered a dual treatment typically used for high-risk cardiac patients.

After five days, the machines were no longer being used, and Smith was able to recover within few weeks.

ADVERTISEMENT

“It makes you look at life and appreciate life much better now, knowing that … two months ago, basically I would have died,” said Smith, who went back to his job as a warehouse worker in Philadelphia.

The Abiomed Impella heart pump is not a new tool, but it is the first time FDA has received approval of the emergency use for curing the heart in combination with an ECMO for Covid-19 patients.

“It’s been around for a while because people have noticed that if a patient has to go on ECMO, sometimes the ECMO puts too much of a load on the heart,” said Dr. Charles Simonton, Abiomed chief medical officer, “but it does have a unique application for Covid, since there’s no other option like this for patients.”

ADVERTISEMENT

The FDA authorized the emergency use of Abiomed’s Impella earlier in summer as a standalone treatment to keep Covid-19 patients stable following the removal of pulmonary blood clots.

Smith was one of three patients who were given the combination treatment in Pennsylvania this spring, and all three patients were able to recover. While coronavirus patients often suffer health issues after recovery, Smith did not manifest physical after-effects.

“His heart is normal, which is incredible. They even did a cardiac MRI to look for a scar or residual inflammation and it was normal,” as were his lungs and kidneys, said Finley.

“They saved my life!” Smith said. “A million times I say thank you!”

Leading cause of death

The use of the Abiomed Impella heart pump comes as good news since statisticians believe that coronavirus may become a leading cause of death in the US.

The US Centers for Disease Control and Prevention may not be able to rank leading causes of deaths until the end of 2020 since it requires a full year’s worth of data. However, statisticians told CNN that Covid-19 may become a leading cause of death in the US.

“We know that based on the # of COVID-19 deaths so far in 2020, it will end up as a Top 10 leading cause of death but won’t know exactly how high it will rank until next year,” CDC mortality statisticians said via email Thursday.

“Heart Disease and Cancer, the two leading causes of death in the U.S., account for more than half of all deaths in the U.S. each year and that isn’t expected to change.”