June 1, 2020
FDA Issues Emergency Use Authorization for Impella RP as Therapy for COVID-19 Patients With Right Heart Failure
June 1, 2020—Abiomed announced that the FDA has issued an emergency use authorization (EUA) for the company’s Impella RP to include patients with COVID-19–related right heart failure or decompensation, including pulmonary embolism (PE).
The authorization letter from the FDA states, “Based on extrapolation of data from the approved indication and reported clinical experience, FDA has concluded that the Impella RP may be effective at providing temporary right ventricular support for the treatment of acute right heart failure or decompensation caused by COVID-19 complications, including PE.”
The EUA states, “The Impella RP system is authorized to be used by health care providers in the hospital setting for providing temporary right ventricular support for up to 14 days in critical care patients with a body surface area ≥ 1.5 m2, for the treatment of acute right heart failure or decompensation caused by complications related to coronavirus disease 2019 (COVID-19), including PE.”
Impella RP received FDA approval in 2017 for treating right ventricular failure in the setting of acute myocardial infarction and after cardiac surgery. Biventricular cardiac support can be provided when Impella RP is used in combination with left-side Impella devices.
According to Abiomed, Impella RP has become a therapeutic option for clinicians treating certain COVID-19 patients experiencing right heart failure. The virus can create a prothrombotic environment in some patients—resulting in acute PE, which may lead to acute right ventricular failure. For critically ill patients, the Impella RP can be rapidly deployed in a matter of minutes using a minimally invasive technique in the cardiac catheterization laboratory or operating room.
Abiomed’s announcement illustrated the use of the Impella RP in these circumstances to treat a Detroit-area patient, a woman aged 59 years who was diagnosed with COVID-19 and benefited from Impella RP therapy at Ascension St. John Hospital in Detroit, Michigan.
Interventional cardiologist Amir Kaki, MD, Director of Mechanical Circulatory Support at Ascension St. John Hospital, and Ted Schreiber, MD, Chief of Cardiology at Ascension St. John Macomb-Oakland Hospital, diagnosed the patient with an acute PE. After the clot was removed, the patient went into right ventricular failure and became hypotensive.
Dr. Schreiber and Dr. Kaki quickly placed an Impella RP and observed what they described as a “dramatic and immediate” improvement in arterial pressure. Over the next 5 days, the Impella RP remained in place and the patient was monitored remotely using cloud-based Impella Connect technology. On the fifth day, Impella RP was removed. The patient was later discharged home with her native heart. This case has been highlighted in the American College of Cardiology’s educational programming on COVID-19 and can be reviewed online, stated the company.
Dr. Kaki commented in the company’s announcement, “Acute PE is clearly being recognized as a life-threatening manifestation of COVID-19. Impella RP is an important tool to help cardiologists save lives during this pandemic. As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be lifesaving.”
Dr. Schreiber added, “This patient demonstrated a profound recovery after placement of Impella RP. In the course of 30 seconds, there was a dramatic and immediate hemodynamic response, and the patient’s blood pressure markedly improved. This case demonstrates the efficacy and robustness of Impella RP in the setting of right ventricular failure.”