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The Door to Unload (DTU) STEMI Safety & Feasibility Pilot Trial
November 2018
For safety information associated with Abiomed’s technologies, visit www.protectedpci.com/hcp/information/isi and www.cardiodenicshock.com/hcp/information/isi.
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certain foreign countries. Impella ECP, Impella 5.5, Impella BTR, cVAD Registry and Recovering hearts. Saving lives. is a trademark of Abiomed, Inc.
CO CO
LA LA
Stretch Stretch
MAP MAP pVAD Support
LVEDP LVEDP
LVEDV LVEDV
Wall
Wall Stress Stress
MVO2
MVO2 AAR AAR
?
Pilot
80
60
40
20
0
Reperfusion 15 min 30 min Unloading After
Alone Reperfusion
Unloading + Delayed
Esposito, Zhang, Qiao and Kapur et al JACC 2018 Reperfusion 5
Door To Unload: STEMI Pilot Trial: Central Hypothesis
6
Results: Procedural Characteristics
Clinical Variable U-IR (n=25) U-DR (n=25)* p-value
LAD Culprit, n (%) 25 (100) 24 (100) NS
Proximal LAD Lesion Location, n (%) 17 (68) 19 (76) NS
Mid LAD Lesion Location, n (%) 8 (32) 5 (21) NS
Successful Impella CP Implant, n (%) 25 (100) 25 (100) NS
Pre-PCI TIMI Flow (After Impella CP Activation) NS
Pre-Intervention TIMI Flow 0-1, n (%) 16 (64) 10 (40) NS
Pre-Intervention TIMI Flow 2-3, n (%) 9 (36) 15 (60) NS
Post-Intervention TIMI Flow NS
Post-Intervention TIMI Flow 3, n (%) 25 (100) 24 (100) NS
45
U-DR
40
U-IR
35
30 minutes of
30 LV Unloading
25
20
15
10
5
0
Enrolled Patients
8
DTU-STEMI Results: 3-5 Day CMR Parameters
Infarct Size vs Myocardial Salvage Microvascular
Total LV Mass (%) Index (%) Obstruction (%)
40 80 10
35 70 9
8
30 60
7
25 50 6
20 40 5
15 30 4
3
10 20
2
5 10 1
0 0 0
U-IR U-DR CRISP U-IR U-DR CRISP U-IR U-DR CRISP
AMI AMI AMI
60 15
20
19 16
40
10
20
0 0
Total STE>4 STE>5 STE>6 Total STE>4 STE>5 STE>6
U-DR U-IR
10
What did we learn from this Pilot Study?
• The Door-To-Unload in STEMI Pilot Trial demonstrates for the first time
that LV unloading using the Impella CP device with a 30-minute delay
before reperfusion is safe and feasible within a relatively short DTB
Time.
• Among patients with sum STE>6mm, infarct size normalized to the area
at risk was significantly lower with 30 minutes of LV unloading before
reperfusion compared to LV unloading and immediate reperfusion.
11
12
• TIMI Flow – A scoring system from 0 – 3 of the coronary flow rates estimated visually on angiography developed by investigators at Thrombolysis in Myocardial Infarction Study Group.
TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond
the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is
normal flow which fills the distal coronary bed completely
• LVEF – Left ventricular ejection fraction – the amount of volume of blood ejected from the heart each beat expressed as a percent of the diastolic volume
• LVEDP – Left ventricular end diastolic pressure in mmHg
• MAP – Mean arterial pressure in mmHg
• CRISP-AMI – A study evaluating use of Intra-aortic balloon pump (IABP) placed before reperfusion in Anterior STEMI – results failed to show a benefit compared to PPCI alone with a
trend toward larger infarcts with IABP – published in JAMA. 2011;306(12):1329-1337