FDA Issues Emergency Use Authorization for Impella Heart Pumps to Provide Unloading Therapy to COVID-19 Patients
The United States Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for left-sided Impella heart pumps to provide left ventricular unloading and support to COVID-19 patients who are undergoing ECMO treatment and develop pulmonary edema or myocarditis. Impella is manufactured by Abiomed.
COVID-19 causes widespread inflammation which can result in damage to the lungs and heart. This damage may cause severe left ventricular dysfunction manifesting as pulmonary edema and/or myocarditis. Impella combined with ECMO therapy (known as ECpella) has become an important tool for physicians treating COVID-19 patients suffering from both heart and lung failure.
“The early clinical evidence continues to accrue in favor of including left ventricular unloading in many patients on ECMO,” said Christian Bermudez, MD, surgical director, lung transplantation and ECMO, and professor of surgery at the University of Pennsylvania. “The superior clinical outcomes from 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.”
42-year-old Devan Smith, a warehouse worker from Pennsylvania who contracted COVID-19 in May, is an example of a patient who benefited from the unloading effect of Impella. After contracting COVID-19, Devan became severely ill with severe myocarditis, multiorgan failure and respiratory failure. Dr. John Finley, interventional cardiologist at Mercy Catholic Medical Center-Fitzgerald Campus in Darby, Pennsylvania, placed venous arterial (V-A) ECMO to combat the respiratory effects of COVID-19 and placed Impella CP to unload Devan’s heart and allow it to rest and recover. After four days of support, Devan’s heart showed dramatic improvement and he was weaned off Impella. The next morning, he was taken off ECMO support. After three weeks in the hospital, Devan returned home with his native heart functioning normally. In July, he returned to work.
“I’m so thankful for the physicians, nurses and staff who saved my life,” said Smith. “My recovery was made possible by their use of life-saving therapies, like Impella and ECMO, that allowed my body to overcome COVID-19.”
“As a community hospital, we are proud to offer patients initiation of advanced mechanical circulatory support treatment options. In this case, ECpella allowed us to support both his circulatory collapse and recurrent life-threatening arrhythmias, as a tertiary center helped treat the virus,” said Dr. Finley. “It is remarkable to see the patient return home with completely normal heart function, normal respiratory and renal function. This case is a testament to the capabilities of ECpella in the setting of severe COVID-19 infection and myocardial involvement. Without our advanced treatment offerings of ECpella, this extremely ill patient would not have survived this COVID-19 infection.”
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