FDA EUA Issued 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.

Impella is the world’s smallest heart pump. It first received FDA clearance in 2008 and FDA PMA approval as safe and effective in 2015. During the last 10 years, Impella has provided left ventricular unloading to approximately 10,000 ECMO patients in cardiogenic shock. The FDA’s EUA expands the use of Impella as an ECMO unloading therapy to include COVID-19 patients with pulmonary edema or myocarditis.

“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.”

This is the second EUA the FDA has granted for Impella during the COVID-19 pandemic. On May 29, 2020, the FDA issued an EUA to expand the use of Impella RP to include patients suffering from COVID-19-related right ventricular complications, including right ventricular dysfunction associated with pulmonary embolism. Combined, the two EUAs authorize the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella RP for use in COVID-19 patients. Impella is the only cardiovascular therapeutic device that has received FDA emergency use authorization to treat COVID-19 patients.

Published academic research presented to the FDA that demonstrates the feasibility of ECpella to improve left ventricular function and provide oxygenation to patients includes:

• Pappalardo et al., European Journal of Heart Failure, 2017: This study compared ECpella patients with patients treated with ECMO only and found patients in the ECpella group had a significantly lower hospital mortality (47% vs. 80%, p< 0.001) and a higher rate of successful bridging to either recovery or further therapy (68% vs. 28%, p < 0.001) compared with ECMO patients.
• Schrage et al., Journal of the American College of Cardiology, 2018: In this study, 106 consecutive patients were treated with Impella in addition to VA-ECMO for cardiogenic shock and 51.9% of all patients were successfully weaned from VA-ECMO support. In the overall cohort, survival at day 30 was 35.8%, which was higher than predicted by the SAVE score (20%) or by the SAPS-II score (6.9%).
• Patel et al., ASAIO Journal, 2019: This retrospective study compared mortality outcomes and duration of support, stroke, major bleeding, hemolysis, inotropic score, and cardiac recovery for patients treated for refractory cardiogenic shock with ECMO versus ECpella. ECpella patients were associated with lower mortality rates, lower inotrope use, and comparable safety profiles as compared with ECMO alone.
• Russo et al., Journal of the American College of Cardiology, 2019: This meta-analysis examined the efficacy and safety of left ventricular unloading strategies during ECMO in patients with cardiogenic shock and found left ventricular unloading was associated with decreased mortality.