Impella Support Pre-PCI for AMICS is Associated with Higher Survival in Women
Reference: J Interven Cardiol 2016; 29:248–256.
Cardiogenic shock (CS) is the leading cause of death after acute myocardial infarction (AMI) and occurs in up to 10% of cases.1 Notably, the incidence of CS is higher in women presenting with STEMI than men (11.6% vs. 8.3%, p < 0.01).2 Previous studies evaluating the impact of CS on in-hospital mortality among women versus men show varied outcomes, depending on the treatment strategy and timing of therapy.1 Given the encouraging results of improvement in survival in AMICS with use of mechanical circulatory support (MCS) devices such as Impella® heart pumps, Joseph et al. compared the clinical outcomes between men and women supported with Impella 2.5 for AMICS.3
In this retrospective study, a total of 180 patients enrolled in the catheter-based Ventricular Assist Device (cVAD) study who received PCI and hemodynamic support with the Impella 2.5 for AMICS between December 2007 and November 2013 were analyzed. Of the 180 patients, 129 (71.7%) had STEMI and 49 (27.2%) were women. Compared to men, women were older (71.0 years vs. 63.8 years, p = 0.001), had smaller body surface area (1.8 m2 vs. 2.04 m2, p < 0.0001), and were less likely to smoke (25.5% vs. 53.4%, p = 0.001). At presentation, 35.7% of women had cardiogenic shock for >24 hours compared to 21.6% of men and more women had sustained cardiac arrest (67.4% vs. 49.6%, p = 0.03). Despite having higher left ventricular ejection fractions at baseline (30% in women vs. 24.2% in men, p = 0.01), women had higher Society of Thoracic Surgeons (STS) mortality scores (27.9 vs. 20.8, p = 0.01).
Following initiation of hemodynamic support with Impella 2.5, significant improvement in hemodynamics was observed in both men and women. Although the Thrombolysis in Myocardial Infarction (TIMI) score of 0/1 post PCI was higher in women than men (13.7% vs. 3.1%, p < 0.001), no sex-specific difference in survival to discharge rate was observed (38.8% in women vs. 46.6% in men, p = 0.3). The overall survival rate was higher among patients receiving Impella support pre-PCI compared to those receiving Impella support post-PCI (57.3% vs. 35.2%, p = 0.003), in line with previous reports of Impella in AMICS.4,5
Importantly, the magnitude of survival benefit with Impella support pre-PCI was greater among women than men. Among women, survival to discharge was 69% for those receiving Impella support pre-PCI vs. 24% for those receiving Impella support post-PCI (p = 0.005). On the other hand, in men survival was 57% for those who received Impella pre-PCI vs. 35% for those who received Impella support post-PCI (p = 0.1). However, no difference in time to treatment was observed between men and women. In addition, no sex-specific difference in in-hospital complications was observed except for higher incidence of insertion site hematoma in women than men (10.2% vs. 2.3%, p = 0.02).
This is the first study to demonstrate that early initiation of hemodynamic support prior to PCI with Impella 2.5 for AMICS is associated with greater survival benefit in women compared to men, despite higher baseline and procedural risks in women. Given the observational nature of this study, additional studies are needed to confirm the findings of this study.
- Kunadian V, Coats L, Kini AS, Mehran R. Cardiogenic Shock in Women. Intervent Cardiol Clin. 2012; 1: 231-243.
- Akhter N, Milford-Beland S, Roe MT, et al. Gender differences among patients with acute coronary syndromes undergoing percutaneous coronary intervention in the American College of Cardiology- National Cardiovascular Data Registry (ACCNCDR). Am Heart J 2009; 157:141-8.
- Joseph SM, Brisco MA, Colvin M, et al. Women With Cardiogenic Shock Derive Greater Benefit From Early Mechanical Circulatory Support: An Update From the cVAD Registry. J Interv Cardiol. 2018; 13(2):81-86. J Interven Cardiol 2016; 29: 248-256.
- O'Neill WW, Schreiber T, Wohns DH, et al. The Current Use of Impella 2.5 in Acute Myocardial Infarction Complicated by Cardiogenic Shock: Results from the USpella Registry. J Intervent Cardiol. 2014; 27:1-11.
- Schroeter MR, Köhler H, Wachter A, et al. Use of the Impella device for acute coronary syndrome complicated by cardiogenic shock – experience from a single heart center with analysis of long-term mortality. J Invasive Cardiol 2016; 28: 467-472.
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: www.protectedpci.com/indications-use-safety-information/