Frequently Asked Questions
Welcome to the ProtectedPCI.com’s Frequently Asked Questions. Click on an category item below to find questions and answers on some commonly asked questions about the Impella device. Watch the videos for a quick summary, or click the links to take a deeper dive into the material.
Randomized Control Trials
- Is there randomized controlled trial data available for Impella® heart pump use in Cardiogenic Shock?
- What are the challenges with conduct of randomized trials in Cardiogenic shock?
- What is the published clinical evidence for Impella use in cardiogenic shock?
- What is NCSI?
- What is the STEMI-DTU Pivotal trial?
- What is the STEMI-DTU Pilot trial?
- What is the rationale for DTU-STEMI Pilot trial?
- What are the results and clinical implications of the DTU-STEMI Pilot trial?
- What is the purpose of the STEMI DTU RCT?
- What causes thrombus formation among blood-contacting medical devices and what can be done to prevent thrombosis?
- Why is systemic anticoagulation needed with Impella devices?
- Why is anticoagulation in the purge needed?
- What is the recommended heparin concentration in the purge solution with Impella devices?
- How is anticoagulation with Impella devices achieved?
- Are there alternatives to heparin while using Impella devices?
Impella in PCI
- What is PROTECT II?
- What patient population was studied in PROTECT II?
- What is the difference between the intent-to-treat (ITT) and per protocol (PP) patient populations in PROTECT II?
- What were the primary endpoints of the PROTECT II study?
- What were the results in PROTECT II?
- Was there a difference in MACCE—death, stroke, large MI, and repeat revascularization—in PROTECT II?
- Why was PROTECT II discontinued early?
- Did the extent of revascularization affect outcomes in PROTECT II?
- What about vascular complications with the larger Impella sheath compared with IABP?
- What did we learn from PROTECT II?
- Are there studies of the cost-effectiveness of Impella?
- What is Protect III?
- How does the patient population in PROTECT III compare to PROTECT II?
- What were the interim findings for PROTECT III?
- What acute kidney injury (AKI) data is available from the PROTECT Series of studies?
- What can we conclude, thus far, from the PROTECT Series of clinical studies?
- Dhruva et al. FAQs
- What was the design and objective of Dhruva et al. published in JAMA in 2020?
- What patient populations were analyzed in Dhruva et al.?
- What results were reported by Dhruva et al. and how do these results compare to other published data?
- What do clinical guidelines say about IABP use?
- Is Abiomed conducting randomized controlled trials (RCTs) of Impella® for cardiogenic shock?
- Amin et al. FAQs
- What was the design and objective of Amin et al.?
- What patient populations were analyzed in Amin et al.?
- What results were reported by Amin et al.?
- How does the data from Amin et al. compare to other published data?
- What do leaders in the field of circulatory support have to say about the Amin et al. data?
Real World Evidence
- What is the function of the Automated Impella® Controller (AIC)?
- What is the purge system?
- What are the components of the purge system?
- What are the approved indications for use for Impella devices?
- When did Impella receive FDA approval?
- How is Impella CP with SmartAssist different from Impella CP?
- How is Impella CP with SmartAssist the same as Impella CP?
- What can the hemodynamic metrics on the Impella console be used for?
- What is left ventricular end-diastolic pressure (LVEDP)?
- How is LVEDP calculated using Impella CP SmartAssist?
- What is cardiac power output (CPO)?
- How is CPO calculated using Impella CP SmartAssist?
- What are the hemodynamic metrics displayed on the Impella controller used for?
- How is hemolysis measured?
- How is Impella designed to minimize hemolysis?
- What factors most likely cause hemolysis with Impella in the clinical setting?
- How does the rate of hemolysis with Impella devices compare to other heart pumps in pre-clinical/bench testing?
- How does the rate of hemolysis with Impella devices compare to other heart pumps in clinical setting?
Access & Closure
- What are best practices for large bore femoral access and closure?
- How is closure managed with Impella devices?
- What size access sheath is used with Impella devices?
- Where can I learn to implant Impella?