Patient Identification
Early Identification of Right Heart Failure and Early Use of Impella RP® is Associated with Significantly Higher Survival Ratef
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 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 (70% vs. 19%, The 70% survival rate is comparable to the pre-PMA RECOVER RIGHT and HDE studies survival rate.f
Early identification of patients requiring right-heart support is critical because studies have shown 1 in 3 AMI cardiogenic shock (AMICS) patients exhibit right heart dysfunction and is associated with 50% in-hospital mortality.g
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.”
References
a. Anderson, M.B., et al. (2015). Benefits of a novel percutaneous ventricular assist device for right heart failure: The prospective RECOVER RIGHT study of the Impella RP device. J Heart Lung Transplant, 34(12), 1549-1560.
b. Mehta, S.R., et al. (2001). Impact of Right Ventricular Involvement on Mortality and Morbidity in Patients With Inferior Myocardial Infarction. J Am Coll Cardiol, 37(1), 37-43.
c. Fincke, R., et al. (2004). Cardiac Power Is the Strongest Hemodynamic Correlate of Mortality in Cardiogenic Shock: A Report From the SHOCK Trial Registry. J Am Coll Cardiol, 44(2), 340-348.
d. O’Neill. Insights from NCSI. TCT Connect 2020.
e. Korabathina, (2012). The Pulmonary Artery Pulsatility Index Identifies Severe Right Ventricular Dysfunction in Acute Inferior Myocardial Infarction. SCAI, 80, 593-600.
f. Impella RP System PMA Post-Approval Study Final Report.
g. Jain, P. et al. (2021), Right Ventricular Dysfunction Is Common and Identifies Patients at Risk of Dying in Cardiogenic Shock. J Card Fail, 27(10), 1061-107)
NPS-1190