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Supplemental Clinical Information
The overall CathPCI Cohort consisted of both the PAS
Cohort and patients who were indicated for PCI but did not
have the same characteristics as the Disrupt CAD III IDE
study. Demographics for the overall CathPCI and PAS
Cohorts were similar; however, the CathPCI Cohort had
a higher prevalence of cardiovascular risk factors including
prior PCI, prior MI, prior CABG, diabetes, dialysis,
cerebrovascular disease and heart failure. The CathPCI
Cohort also included patients with a high degree of
procedural urgency or cardiovascular instability which
are correlated with poor outcomes including: MI within
30 days; PCI indication of STEMI or NSTEMI; PCI status of
emergency or salvage; patients in cardiogenic shock or
with acute heart failure symptoms; those presenting with
acute coronary syndrome (ACS); and those with another
indication of cardiac arrest or instability. These factors were
exclusionary for the PAS Cohort.
An additional analysis confirmed the observed in-hospital
mortality rate in both cohorts (CathPCI Cohort and PAS
Cohort) is consistent with the predicted mortality rate
generated from an established CathPCI model (Table 16).
Using this model and associated bedside risk score, the
observed in-hospital mortality rate for the PAS Cohort was
0.25% vs. 0.31% predicted (p=Non-Significant [NS]); the
observed rate for the CathPCI Cohort was 2.24% vs 2.24%
predicted (p=NS). The overall CathPCI Cohort was further
stratified to show that the observed mortality rates for the
highest risk patients with ACS are also consistent with the
predicted rates, including those with a PCI indication of
non-ST-elevation MI (NSTE-ACS) and ST-elevation MI
(STEMI). As previously noted, patients with these
characteristics were excluded from the PAS Cohort.
Table 16. Observed vs Predicted In-Hospital Mortality
(based on CathPCI Bedside Risk Score)
Observed
Predicted
Cohort
N
In-Hospital
In-Hospital
Mortality
Mortality
CathPCI Cohort
18,893
2.24%
2.24%
PAS Cohort
1,212
0.25%
0.31%
NSTE-ACS
6,200
3.55%
3.79%
NSTE-ACS without
5,886
2.34%
2.40%
Cardiogenic Shock
or Cardiac Arrest
STEMI
611
11.29%
11.63%
STEMI without
490
4.90%
6.20%
Cardiogenic Shock
or Cardiac Arrest
NS = non-significant
Castro -Dominguez YS, et al. Predicting In-Hospital Mortality in Patients
1
Undergoing Percutaneous Coronary Intervention. J Am Coll Cardiol.
2021 Jul 20;78(3):216-229. doi: 10.1016/j.jacc.2021.04.067. Epub 2021 May 3.
PMID: 33957239.
Vandenbroucke JP. A Shortcut Method For Calculating The 95 Percent Confidence
2
Interval of the Standardized Mortality Ratio. (Letter). Am J Epidemiol. 1982 Feb;
115(2):303-4. doi: 10.1093/oxfordjournals.aje.a113306.
LBL 64191 Rev D, Instructions for Use ( June 2023)
How Supplied
The IVL Catheter is supplied sterile via e-beam sterilization
and cable sleeve is sterilized via ethylene oxide. Both the
IVL Catheter and sterile cable sleeve are intended for single
use only. Do not re-sterilize as this could damage the device
and lead to patient injury. Do not reuse the device as this
could result in cross-contamination that could result in
patient injury. Carefully inspect all packaging for damage
or defects prior to use. Do not use the device if there is any
sign of breach of the sterile barrier, as this could indicate
loss of sterility that could result in patient injury. Do not use
the device if there is damage to the package, as this could
lead to device malfunction and result in patient injury. Store
the IVL Catheter in a cool, dark, dry place. Storage of the
device in extreme conditions may damage the device and/or
affect device performance that could lead to patient injury.
Required Devices for the Coronary IVL Procedure
The IVL Catheter is to be used exclusively with the
IVL Generator, IVL Connector Cable and its accessories.
The IVL Connector Cable is a remote actuator which
connects the IVL Generator to the IVL Catheter and is used
to activate the lithotripsy therapy from the IVL Generator.
Refer to the IVL Generator and IVL Connector Cable
Operator's Manual for preparation, operation, warnings
and precautions, and maintenance of the IVL Generator
and IVL Connector Cable.
Contents: Shockwave C
Sterile Cable Sleeve (1)
Devices Required But Not Supplied By
Shockwave Medical, Inc.
• 5F guide catheter and extension(s)
• 0.014" (0.36 mm) Guide Wire (190 cm – 300 cm Length)
• Indeflator
Folded Balloon Diameters:
RR
• 0.044" max. for 2.5 mm
P-value
(95% CI)
2
1
• 0.045" max. for 3.0 mm and 3.5 mm
1.00
NS
• 0.047" max. for 4.0 mm
(0.91 - 1.10)
0.79
NS
Shockwave C
2+
(0.15 - 1.93)
Compliance Chart
0.94
NS
(0.82 - 1.07)
0.98
NS
Pressure
2.5x12 mm
(0.82 - 1.15)
ATM – KPa
Ø (mm)*
0.97
NS
4* – 405
(0.76 - 1.21)
5 – 507
0.79
NS
6* – 608
(0.51 - 1.14)
7 – 709
8 – 811
9 – 912
10*–1013
Coronary IVL Catheter (1) and
2+
Coronary IVL Catheter Balloon
3.0x12 mm
3.5x12 mm
4.0x12 mm
Ø (mm)*
Ø (mm)*
Ø (mm)*
2.4
2.9
3.3
3.9
2.4
2.9
3.3
4.0
2.4
3.0
3.4
4.0
2.4
3.0
3.4
4.0
2.5
3.0
3.5
4.1
2.5
3.0
3.5
4.1
2.5
3.1
3.5
4.2
EN
Note: *Ø (mm) is ± 0.10 mm; 4 atm is IVL treatment
balloon pressure
** 6 atm is nominal balloon pressure and post- treatment
pressure
*** 10 atm is RBP (Rated Burst Pressure) of the balloon
Shockwave C
Coronary IVL System Sequence Chart
2+
The following pulsing sequence must be followed during
treatment. Do not utilize a pulsing sequence other than
those outlined in the IVL System Sequence Chart below.
Insertion of any size Shockwave C
IVL Catheter will
2+
automatically program the IVL Generator with the following
treatment sequence:
Treatment Frequency
Maximum Number of Continuous Pulses (1 cycle)
Minimum Pause Time
Maximum Total Pulses Per Catheter
In the event the user attempts to deliver more than the
maximum number of continuous pulses allowed,
the IVL Generator is designed to stop automatically.
To resume pulsing, wait at least the minimum pause time
before resuming therapy. The therapy button must be
released and pressed again to resume therapy. For more
information, refer to the IVL Generator and IVL Connector
Cable Operator's Manual.
If the maximum pulse count of 120 pulses is reached as
displayed on the generator, the catheter shall not be used
any further. If further therapy is needed, discard this
catheter and obtain a new one. Warning: Do not exceed
80 pulses in the same treatment segment and
therefore 160 pulses in an overlap segment.
Procedural Steps
Caution: Refer to the IVL Generator and IVL Connector
Cable Operator's Manual for preparation, operation,
warnings and precautions, and maintenance of the
IVL Generator and IVL Connector Cable.
Preparation
1. Prepare the insertion site using standard sterile
technique.
2. Achieve preferred vascular access and place
a guidewire and guide catheter.
3. Select a lithotripsy balloon catheter size that is 1:1
based on balloon compliance chart (above) and
reference vessel diameter. The largest diameter balloon
should be used if 1:1 sizing is not available (such as
using a 4.0 mm IVL Catheter in a vessel with a reference
diameter of 4.5 mm).
4. Remove the IVL Catheter from the package.
5. Prepare the lithotripsy balloon using standard
technique. Fill a syringe with 5cc of 50/50 saline/
contrast medium. Attach syringe to inflation port on
catheter hub. Pull vacuum at least 3 times, releasing
vacuum to allow the fluid to replace the air in the
catheter.
1 Pulse per 1 Second
10 Pulses
10 Seconds
120 Pulses
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