Impella RP® as Therapy for COVID-19 Patients with Right Heart Failure

May 31, 2020

Dr. Amir Kaki, an interventional cardiologist and director of mechanical circulatory support at Ascension St. John Hospital in Detroit, presents the case of a COVID-19 patient affected by a hypercoagulable state who had profound right ventricular dysfunction supported with Impella RP®.

The patient was diagnosed with an acute pulmonary embolism and, after the clot was removed, the patient went into right ventricular failure and became hypotensive. Dr. Kaki and his colleague, Dr. Ted Schreiber, quickly placed an Impella RP and observed what they describe as a “dramatic and immediate” improvement in arterial pressure. Over the next five 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 (ACC) educational programming on COVID-19.

 

FDA Issues Emergency Use Authorization (EUA) for Impella RP as Therapy for COVID-19 Patients with Right Heart Failure

 

The United States FDA has issued an EUA for Impella RP to include patients suffering from COVID-19 related right heart failure or decompensation, including pulmonary embolism (PE). Five years of pre- and post-market clinical studies support Impella RP’s safety and efficacy. In 2017, Impella RP received FDA approval as safe and effective 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.

Since the onset of the COVID-19 pandemic, Impella RP has become a therapeutic choice for clinicians treating certain COVID-19 patients suffering right heart failure. COVID-19 can create a prothrombotic environment in some patients resulting in acute pulmonary embolism 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.

Published academic research presented to the FDA that demonstrates the feasibility of Impella RP to improve right ventricular function in patients with pulmonary embolism includes:

  • Zuin, et al., Europe PMC, 2019 – This review of the treatment of pulmonary embolism using Impella RP concludes, “reviewed manuscripts demonstrated a significant hemodynamic improvement with a concomitant reduction of the right ventricle afterload in all patients which exhibit a low mortality rate in the short-term period.”
  • Elder, et al., Journal of Interventional Cardiology, 2018 – This study, reviewing the largest experience of pulmonary embolism patients treated with Impella RP concludes, use of Impella RP in patients with pulmonary embolism and right ventricular failure might improve hemodynamics and facilitate a bridge-to-recovery.
  • Bhatia, et al, Catherization & Cardiovascular Interventions, 2017 – A case review of a 47-year-old man with a massive pulmonary embolism supported with Impella RP for 48 hours. Impella support resulted in immediate increase in mean arterial pressure and decreased vasopressor requirements. The patient was discharged in one week.

The existing FDA PMA labeling for Impella RP and the new EUA for Impella reads as follows:

FDA PMA Indication

The Impella RP System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

Emergency Use Authorization

The Impella RP System is authorized to be used by healthcare providers (HCP) 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 pulmonary embolism (PE).

 

Related Content:

NPS-742
IMP-1385


To learn more about the Impella® platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: abiomed.com/important-safety-information

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