Abiomed Impella 2.5, Инструкция по эксплуатации

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TABLE OF CONTENTS
Figure 7.14 Surgical Mode Enabled ........................................................... 7.25
Figure 8.1 Alarm Window ......................................................................... 8.2
Figure 9.1
Automated Impella ® Controller Patient Environment................ 9.12
Figure 9.2 Impella ® 2.5 Catheter Dimensions ........................................... 9.14
Figure 9.3 Impella CP
®
Catheter Dimensions ............................................ 9.14
Figure 9.4 Impella
®
5.0 Catheter Dimensions ........................................... 9.15
Figure 9.5 Impella
®
LD Catheter Dimensions ............................................ 9.15
TABLES
Table 3.1 Impella
®
Set-up and Insertion Kit Components ........................ 3.2
Table 3.2 Impella ® Axillary Insertion Kit .................................................. 3.2
Table 3.3 Impella ® Catheter Components................................................ 3.7
Table 3.4 Purge Cassette Components.................................................... 3.13
Table 3.5 Impella
®
Catheter and Automated Impella
®
Controller
Accessories .............................................................................. 3.14
Table 4.1 Automated Impella
®
Controller Front View Features ................ 4.3
Table 4.2 Automated Impella
®
Controller Side View Features .................. 4.5
Table 4.3 Automated Impella
®
Controller Display Elements ..................... 4.6
Table 5.1 Evaluation Prior to Inserting the Impella ® Catheter .................. 5.1
Table 5.2 Additional Considerations Prior to Inserting the Impella ® LD
Catheter .................................................................................. 5.1
Table 5.3 P-level Flow Rates for the Impella
®
2.5 Catheter ...................... 5.34
Table 5.4 P-level Flow Rates for the Impella CP ® Catheter ....................... 5.34
Table 5.5 P-Level Flow Rates for the Impella ® 5.0 Catheter ..................... 5.40
Table 5.6 P-Level Flow Rates for the Impella
®
LD Catheter...................... 5.44
Table 6.1 Baseline Demographics and Characteristics ............................. 6.3
Table 6.2 Baseline Hemodynamics .......................................................... 6.3
Table 6.3 Adverse Events Monitoring ...................................................... 6.4
Table 6.4 Site-Reported Adverse Events (to Discharge) by Classification .. 6.13
Table 6.5 Baseline Patient Characteristics ............................................... 6.19
Table 6.6 Baseline Patient Characteristics ............................................... 6.20
Table 6.7 Site-Reported Adverse Events (to Discharge) by Classification .. 6.29
Table 7.1 Guide for Managing Hemolysis in Various Circumstances ......... 7.20
Table 7.2 Recommended Standards for Maintenance of the Placement
Signal for Impella
®
2.5 and Impella CP
®
Catheters ................... 7.22
Table 7.3 Troubleshooting When Operating the Impella ® Catheter in
the Presence of an EAM System............................................... 7.26
Table 7.4 Troubleshooting When Operating the Impella
®
Catheter in
the Presence of a MNS System ................................................. 7.27
Table 8.1 Alarm Levels ............................................................................ 8.1
Table 8.2 Automated Impella
®
Controller Alarm Messages ..................... 8.3
Table B.1 Alternative Guidewires for Impella
®
2.5 System ....................... B.1
Table B.2 Alternative Introducer Sheaths for Impella ® 2.5 and
Impella CP
®
System ................................................................. B.1
Figure 6.10 Survival to Discharge Outcomes (by Device) Between Impella
Registry Subgroups: Patients Likely to be Eligible for RCTs vs.
Patients Likely to be Excluded from RCTs (“Salvage” Patients) . 6.11
Figure 6.11 Kaplan-Meier Curve Estimates for 30-Day Survival .................. 6.12
Figure 6.12 Survival to Discharge in AMICS Cohort .................................... 6.12
Figure 6.13 Improvement in Patient Hemodynamics (from Baseline to 48 Hours
Post Device Implant) for RECOVER I Patients ........................... 6.15
Figure 6.14 Decrease in Inotropes and Pressors (Post-Device Placement) for
RECOVER I Patients ................................................................ 6.15
Figure 6.15 RECOVER I Enrollment ............................................................ 6.19
Figure 6.16 Kaplan-Meier Survival Curve for Freedom from
Death (to 1 Year) .................................................................... 6.21
Figure 6.17 Time Intervals for Impella Implants Data Collection by Type of
Device ..................................................................................... 6.23
Figure 6.18 Kaplan-Meier Curve Estimates for 30 Day Survival - All Patients
Cohort .................................................................................... 6.24
Figure 6.19 Kaplan-Meier Curve Estimates for 30 Day Survival - For Difference
Devices ................................................................................... 6.24
Figure 6.20 Groups Used for Each Classification Analysis ........................... 6.25
Figure 6.21 Kaplan-Meier Curve for 30 Day Survival Using Classification A
(All Patients) ........................................................................... 6.25
Figure 6.22 Kaplan-Meier Curve for 30 Day Survival Using Classification A
(Patients with Impella 5.0/LD) ................................................. 6.26
Figure 6.23 Kaplan-Meier Curve for 30 Day Survival Using Classification A
(Patients with Impella 2.5) ...................................................... 6.26
Figure 6.24 Kaplan-Meier Curve for 30 Day Survival Using Classification B
(All Patients) ........................................................................... 6.26
Figure 6.25 Kaplan-Meier Curve for 30 Day Survival Using Classification B
(Patients with Impella 5.0/LD) ................................................. 6.27
Figure 6.26 Kaplan-Meier Curve for 30 Day Survival Using Classification B
(Patients with Impella 2.5) ...................................................... 6.27
Figure 6.27 Flow Diagram of the Distribution of the AB5000 LVAD PCCS
Patient Cohort ........................................................................ 6.28
Figure 6.28 Kaplan-Meier Curve Estimates for 30 Day Survival ................... 6.28
Figure 6.29 Improvement in Patient Hemodynamics (from Baseline to 48 Hours
Post-Device Implant) for RECOVER I Patients .......................... 6.30
Figure 6.30 Decrease in Inotropes and Pressors (Post-Device Placement) for
RECOVER I Patients ................................................................ 6.30
Figure 7.1 Labeled TEE and TTE Images of the Impella
®
Catheter
Position ................................................................................... 7.4
Figure 7.2 Transesophageal Echocardiographic (TEE) Illustrations of
Impella
®
Catheter Position ....................................................... 7.7
Figure 7.3 Transthoracic Echocardiographic (TTE) Illustrations of
Impella
®
Catheter Position ....................................................... 7.8
Figure 7.4 Correct and Incorrect Impella
®
Catheter Position
(Color Doppler TTE) ................................................................. 7.9
Figure 7.5 Correct Impella CP
®
Catheter Position
(similar for Impella ® 2.5) .......................................................... 7.11
Figure 7.6 Correct Impella ® 5.0 Catheter Position
(similar for Impella
®
LD) ........................................................... 7.11
Figure 7.7 Impella CP
®
Catheter Fully in Ventricle
(similar for Impella
®
2.5) .......................................................... 7.12
Figure 7.8 Impella CP
®
Catheter Completely in the Aorta or Inlet and
Outlet Areas in Ventricle and Open Pressure Area in Aorta
(similar for Impella
®
2.5) .......................................................... 7.13
Figure 7.9 Impella CP
®
Catheter Position Unknown
(similar for Impella ® 2.5) .......................................................... 7.14
Figure 7.10 Impella
®
5.0 Catheter Position Wrong
(similar for Impella ® LD) ........................................................... 7.15
Figure 7.11 Impella ® 5.0 Catheter Position Unknown
(similar for Impella
®
LD) ........................................................... 7.16
Figure 7.12 Impella
®
5.0 Catheter Outlet Area on or near Aortic Valve
(similar for Impella
®
LD) ........................................................... 7.17
Figure 7.13 Displacing Air During Flush Solution Change Out Procedure ... 7.22