Case Review, COVID-19, Right Heart Failure
Impella RP® for COVID-19 Patients with Right Heart Failure
Amir Kaki, MD, FACC, FSCAI, presents the case of a COVID-19 patient affected by a hypercoagulable state who had profound right ventricular dysfunction supported with Impella RP. Dr. Kaki is an interventional cardiologist and director of mechanical circulatory support at Ascension St. John Hospital in Detroit.
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, Ted Schreiber, MD 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 the cloud-based Impella Connect® system. 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 the safety and efficacy of Impella RP. 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 FDA PMA approved labeling for Impella RP and the new EUA for Impella reads as follows:
PMA APPROVED INDICATION
The Impella RP® System, Impella RP® with SmartAssist® and Impella RP Flex™ with SmartAssist® are 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 for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant, or open‐heart surgery, without the presence of profound shock, end organ failure, or acute neurologic injury.
EMERGENCY USE AUTHORIZATION
Only 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). The Impella RP has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb‐3(b)(1), unless the authorization is terminated or revoked sooner.