Abiomed Impella 2.5, Instructions For Use Manual

Page: 116 / 211

6.8 Instructions for Use & Clinical Reference Manual (US)
Figure 6.5 Time intervals for Impella implants data collection by type of device
Cases were initially identified using Abiomed’s commercial patient tracking system, and then
further reviewed to verify that each case was applicable for this supplement (i.e. was an AMICS
patient). Using this method, three hundred twenty four (324) Impella cases were enrolled into
the U.S. Impella Registry for this analysis. These included 189 Impella 2.5 cases, 111 Impella CP
cases and 24 (combined) Impella 5.0 and Impella LD cases.
The data included: patient’s demographics and baseline characteristics (risk factors, medical
history and history of previous cardiac interventions), clinical presentation for the index
hospitalization, index cardiac procedure information, Impella device information, hemodynamic
parameters pre, during and post Impella support, cardiovascular medication, laboratory results,
patient’s outcome information at discharge and 30-day follow-up as well as site-reported
adverse events. Both site-reported safety data and CEC-adjudicated data are presented.
The data showed that AMICS patients were on average 65 years old, the majority were male
(75%) with significant risk factors and comorbidities including smoking (48%), diabetes (42%),
hypertension (71%), renal insufficiency (24%), a Society of Thoracic Surgery (STS) scores for
mortality of 21% and morbidity of 60%. The patients presented with high heart rate, poor
hemodynamics despite pressors and inotropes, signs of tissue hypoperfusion (lactates) and
end-organ dysfunction (creatinine). These characteristics were generally the same for all Impella
devices, except for: the gender distribution had more male patients in the Impella 2.5 and
Impella CP groups (compared to Impella 5.0/LD) and a higher proportion of patients transferred
from outlying facility in patients supported with the Impella 5.0/LD (compared to patients
supported with the Impella 2.5 or Impella CP).