Basics
Who was the first author? And where is he from?
George Dangas, Mt. Sinai School of Medicine
How many IABP/ Impella patients were treated?
IABP 211; Impella 216
What impella device was used in the study?
Impella 2.5
What were the 90 day MAE rate?
Impella 37%
IABP 49%
P= 0.014
Who was the second author? And where were they from?
William O’Neill, Henry Ford Health System
What were the composite endpoints?
90 days, MAE and MACCE
What was the mean EF in the patient cohort?
24%
What were the 90 day MACCE rates?
Impella 22%
IABP 31%
P = 0.014
What is the Objective?
To identify the effects of clinically relevant periprocedural myocardial infarction (pMI) instead of original definition on outcomes in Protect II
How many patients were declared inoperable by Cardiac Surgeons?
2/3 of patients
Wasn’t PII a failed study? Why would this data be relevant?
End points were driven by pMI, many of which were characterized by small to moderate elevations of CK-MB/Troponin which in most studies have not been found to have prognostic relevance.
What was significant about the log-rank test?
29% reduction of MACCE at 90 days in Impella arm
What was the periprocedural myocardial infarction definition in Protect II?
PMI >= 3X ULN
What was the periprocedural myocardial infarction (pMI) defined as?
New on set Q waves or CK-MB elevation >8X Normal
When was this article published?
2014
What percent of each group were discharged from CCL on device?
Impella 6%
IABP 38%
What patients were included? CGS and/or HRPCI?
HRPCI randomized to IABP or Impella
What are the study limitation?
Post-hoc Should be considered hypothesis generating
What is important to note about the log-rank test during the first few days of hospital care?
No change in MAE rate between two arms.
Independent predictors of adverse events at 90 days in the PP population; what percent risk reduction in MACCE for the Impella arm?
23% Risk reduction MACCE for Impella