Patient Identification
Early Identification of Right Heart Failure and Early Use of Impella RP® is Associated with Significantly Higher Survival Rate
The prospective, multi-center FDA PMA post-approval study compared survival in patients who would have met enrollment criteria for the RECOVER RIGHT trial to those who would not have qualified for the trial because they were in cardiogenic shock for more than 48 hours. The ongoing PMA post-approval study found patients who received Impella RP support within 48 hours of cardiogenic shock onset had a significantly higher survival rate than those who received delayed right-heart support (73% vs. 14%, p<0.001)a. The 73% survival rate is comparable to the pre-PMA RECOVER RIGHT and HDE studies survival rate.
Data presented at TCT Connect 2020, the 32nd annual scientific symposium of the Cardiovascular Research Foundation, finds early identification of right heart failure and early use of Impella RP is associated with significantly higher survival rates. Early identification of patients requiring right-heart support is critical because prior studies have shown 37% of AMI cardiogenic shock (AMICS) patients exhibit right heart dysfunctiona, which results in a three-times increased risk of mortalityb.
How to Identify Right Ventricular Failure (RVF)
Cardiac index <2.2 L/min/m2 despite continuous high dose inotropes (as defined by the RECOVER RIGHT clinical trial), and any of the followinga:
- CVP >15 mmHg
- CVP/PCWP >0.63
Moderate to severe global right ventricular (RV) dysfunction on echo defined as one of the followinga:
- Global RV hypokinesis
- TAPSE score of ≤14 mm
- RV diameter at base >42 mm
- RV short axis (or mid-cavity) diameter >35 mm
Importance of Identifying Right Ventricular Failure
- RVF can occur after acute myocardial infarction (AMI), after durable LVAD implantation, post-cardiotomy or post-transplant
- RVF increases the risk of cardiogenic shock, high-grade atrioventricular-conduction block and in-hospital mortalityb
- RVF can lead to longer ICU stays, higher short-term mortality and worsening end-organ dysfunction
Criteria for Consideration of Right-Sided Support in AMI Cardiogenic Shock
Hemodynamic Parameters
- CPOb <0.6
- Lactatec >4
- PAPId <1.0
- CI < 2.2 L/min/m2 (despite inotropic support)d
“Prolonged diastolic suction alarms can be an early marker of right ventricular failure in patients with elevated filling pressures.”
Impella RP for COVID-19 Patients with Right Heart Failure
Amir Kaki, MD, presents the case of a COVID-19 positive patient affected by a hypercoagulable state who had profound right ventricular dysfunction related to massive acute pulmonary embolus.
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). 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.
References
a. Anderson, M.B., et al. (2015). J Heart Lung Transplant, 34(12), 1549-1560.
b. Mehta, S.R., et al. (2001). J Am Coll Cardiol, 37(1), 37-43.
c. Fincke, R., et al. (2004). J Am Coll Cardiol, 44(2), 340-348.
d. O’Neill. Insights from NCSI. TCT Connect 2020
e. Korabathina, (2012). SCAI, 80, 593-600.
f. Mehta, et al. (2018). J Am Coll Cardiol, 24, 148-156.
g. Impella RP System PMA Post-Approval Study Final Report.
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