Griffith RECOVER I

Question 1

Study design

Answer 1

Multicenter prospective study of Impella 5.0 for postcardiotomy circulatory support

Question 2

Primary endpoint

Answer 2

Safety endpoint was frequency of major adverse events (death & stroke)@ 30 days or discharge

Question 3

Primary safety endpoint outcomes

Answer 3

1 death & 1 stroke 13% (2/16 patients)

**The death was post-transplant experiencing early complications with profuse bleeding, renal failure, metabolic acidosis culminating in Cardiogenic Shock

**Non-fatal stroke was admitted in Cardiogenic Shock on IABP support & mechanical ventilation after failed PTCA. Underwent emergency CABG followed by support with Impella 5.0. Shortly after showed RHF and was supported w/ Levitronix RVAD. After removal of devices, scan showed multiple cerebral infarcts. Unable to determine time of onset of the stroke.

Question 4

Primary efficacy endpoint

Answer 4

Recovery of native heart function was 93% of patients discharged with bridge to other therapy in 7%

Question 5

Survival @30 days, 3 months, 1 year

Answer 5

30 days = 94%
1- month= 81%
1-year= 75%

Question 6

N= ?

Answer 6

16 patients

Question 7

Hemodynamic improvements

Answer 7

Immediately after initiation of support:
Cardiac index 1.65 versus 2.7 L/min/m2
MAP 71.4 versus 83.1 mm Hg

Pump provided avg. 4.0 Liters of flow for average duration of 3.7 days (1.7-12.6 days)

Question 8

Study population in Cardiogenic Shock or Low Cardiac Output Syndrome

Answer 8

Cardiac Index >/=1.3 - =2.2 L/min/m2 AND elevated filling pressures
Wedge >25-<35 mm Hg
OR PAD >25-<35 mm Hg
After weaning from Bypass despite 1 high dose inotrope or 2 Medium doses

Question 9

Patient characteristics

Answer 9

Mean EF 23% (10-35%)

Question 10

Hemolysis

Answer 10

1/16 = 6.25%