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Table 12. Summary of PPM/ICD Events (CAD I-IV Pooled
Safety Set)
CAD I
CAD II
CAD III
1
2
Prior PPM/ICD
11.7%
5.8%
6.3%
(7/60)
(7/120)
(27/431)
AEs Relevant to
0.0%
0.0%
11.1%
Potential PPM/ICD
(0/7)
(0/7)
(3/27)
Interaction
PPM/ICD Events
0.0%
0.0%
0.0%
5
(0/7)
(0/7)
(0/27)
Arrhythmia
0.0%
0.0%
11.1%
(0/7)
(0/7)
(3/27)
Hemodynamic
0.0%
0.0%
0.0%
Events
(0/7)
(0/7)
(0/27)
7
IVL-related AEs
0.0%
0.0%
0.0%
Relevant to Potential
(0/7)
(0/7)
(0/27)
PPM/ICD Interaction
Adverse pacing/
0.0%
0.0%
0.0%
ICD
(0/7)
(0/7)
(0/27)
5
Arrhythmia
0.0%
0.0%
0.0%
(0/7)
(0/7)
(0/27)
Hemodynamic
0.0%
0.0%
0.0%
events
(0/7)
(0/7)
(0/27)
7
1. CAD I includes all AEs reported during the study follow-up period (180 days).
2. CAD II includes all AEs reported during the study follow-up period (30 days).
3. CAD III includes all AEs reported as of June 28, 2020 during the study follow-up
period (24 months).
4. CAD IV includes all AEs reported as of August 6, 2020 during the study follow-up
period (24 months).
5. Inappropriate ICD shock, transient pacing inhibition
6. All 3 subjects had medical history of arrhythmia; no events were device-related
and all occurred > 30 days after index procedure.
7. Hypotension, cardiogenic shock, hemodynamic instability.
Post-Approval Study Summary
Shockwave Medical conducted a PMA Post Approval Study
(PAS) to assess the utilization, safety, and effectiveness of
the Shockwave Coronary IVL System in a "real-world"
setting. The Disrupt CAD III PAS was a prospective,
multicenter, observational, single-arm post-approval study
using data collected from the National Cardiovascular Data
Registry (NCDR
) CathPCI Registry
.
®
®
The safety endpoints for the Disrupt CAD III PAS are based
on site-reported data and include all-cause death,
procedure-related adverse events, and IVL-specific data
points. The IVL-specific data points were IVL-related
ventricular arrhythmia, IVL balloon loss of pressure and
related serious dissections, and safety of IVL in patients
with PPM/ICD.
Patients were enrolled in the CathPCI Registry who were
confirmed to have a lesion treated with a Shockwave C
Coronary IVL Catheter (hereafter referred to as the "CathPCI
Cohort"). Of the procedures in the CathPCI Cohort, 1,212
(6.4%) met the following eligibility criteria: severely
calcified, stenotic de novo coronary artery lesions presenting
with stable, unstable, or silent ischemia that are suitable for
percutaneous coronary intervention (PCI) and had clinical
characteristics similar to the Disrupt CAD III IDE study. This
group is referred to as the "PAS Cohort" and is considered
the enrolled population. Demographics for the PAS Cohort
and overall CathPCI Cohort are summarized in Table 13.
LBL 64191 Rev D, Instructions for Use ( June 2023)
Table 13. Patient Baseline Characteristics of CathPCI
Cohort and PAS Cohort
CAD IV
Pooled
Measure
3
4
1.4%
6.1%
Age (yrs), Mean ± StdDev
(1/72)
(42/683)
Gender
0.0%
7.1%
Female
(0/1)
(3/42)
Male
Race, % (n/N)
0.0%
0.0%
(0/1)
(0/42)
White
0.0%
7.1%
Black/African American
(0/1)
(3/42)
6
Asian
0.0%
0.0%
American Indian/
(0/1)
(0/42)
Alaskan Native
0.0%
0.0%
Native Hawaiian/
(0/1)
(0/42)
Pacific Islander
Hispanic Origin
0.0%
0.0%
Prior Percutaneous Coronary
(0/1)
(0/42)
Intervention (PCI)
0.0%
0.0%
Prior Myocardial Infarction
(0/1)
(0/42)
MI within 30 Days
0.0%
0.0%
(0/1)
(0/42)
Prior Coronary Artery
Bypass Graft
Diabetes Mellitus
Currently on Dialysis
Cerebrovascular Disease
Heart Failure
PCI Indication: STEMI
PCI Indication: NSTEMI-ACS
PCI Status: Emergency
or Salvage
Cath Lab Visit Indication:
Acute Coronary Syndrome (ACS)
Other Indication of Cardiac
Arrest or Instability
The Primary Safety results for the PAS and CathPCI Cohort
are summarized in Table 14.
Table 14. Summary of Safety Data for the CathPCI Cohort
and PAS Cohort
Safety Endpoint
All-Cause Death
Death at Discharge
Procedure-Related Adverse
Events (AEs)
Any Procedure-Related AE
Coronary Artery Perforation
Coronary Artery Dissection
(C and above)
2
A summary of IVL-specific data points for the CathPCI and
PAS Cohorts is shown in Table 15. There were no instances
of adverse device interaction (inhibition of pacing,
inappropriate shock, required device reprogramming)
reported in PPM/ICD patients.
CathPCI Cohort
PAS Cohort
(N=18,893)
(N=1,212)
72.8 ± 9.8
73.4 ± 9.0
29.0% (5,475/18,893)
27.2% (330/1,212)
71.0% (13,418/18,893)
72.8% (882/1,212)
87.4% (15,953/18,243)
90.7% (1,061/1,170)
7.5% (1,376/18,243)
5.9% (69/1,170)
2.0% (373/18,243)
1.3% (15/1,170)
0.6% (101/18,243)
0.2% (2/1,170)
0.2% (39/18,243)
0.0% (0/1,170)
5.9% (1,103/18,734)
5.6% (67/1,200)
52.6% (9,933/18,893)
38.9% (471/1,212)
34.7% (6,558/18,893)
20.6% (250/1,212)
3.8% (721/18,893)
0.0% (0/1,212)
20.5% (3,880/18,893)
16.6% (201/1,212)
51.8% (9,784/18,893)
44.3% (537/1,212)
7.5% (1,412/18,893)
0.0% (0/1,212)
21.7% (4,109/18,893)
17.3% (210/1,212)
42.1% (7,960/18,893)
24.3% (295/1,212)
3.2% (611/18,881)
0.0% (0/1,212)
32.8% (6,200/18,881)
0.0% (0/1,212)
4.3% (815/18,889)
0.0% (0/1,212)
38.1% (7195/18,893)
0.0% (0/1,212)
1.6% (301/18,893)
0.0% (0/1,212)
CathPCI Cohort
PAS Cohort
% (n/N)
% (n/N)
2.2% (423/18,893)
0.2% (3/1,212)
7.7% (1,458/18,893)
2.9% (35/1,212)
0.7% (129/18,893)
0.6% (7/1,212)
0.9% (169/18,893)
0.4% (5/1,212)
EN
Table 15. Safety Endpoint: IVL-Specific Data Points (from
IVL Auxiliary Data Collection Form)
CathPCI Cohort
Measure
% (n/N)
IVL Auxiliary Forms Completed
11.1% (2,077/18,776)
Safety Endpoint:
IVL-Related Ventricular
Arrhythmia
Sustained Ventricular Arrhythmia
0.2% (5/2,077)
(during IVL device utilization)
Cardiac Arrest
0.1% (3/2,077)
Safety Endpoint: IVL Balloon
Loss of Pressure and Related
Serious Dissections
Balloon Loss of Pressure/Rupture
1.2% (24/2,077)
Serious Coronary Dissection
0.0% (1/2,077)
following Balloon Loss of
Pressure/Rupture
Safety Endpoint: Safety of IVL
in Patients with PPM/ICD
Total Patients with Cardiac
6.9% (143/2,077)
Implantable Electronic Device (CIED)
(PPM or ICD)
Permanent Pacemaker (PPM)
32.9% (47/143)
Implantable Cardioverter
67.1% (96/143)
Defibrillator (ICD)
Inappropriate Inhibition of Pacing
0.0% (0/143)
during IVL Device Utilization
(PPM or ICD)
Device Reprogramming Required
0.0% (0/143)
During or After PCI Procedure
(PPM or ICD)
Inappropriate ICD Shocks Delivered
0.0% (0/47)
during IVL Device Utilization
(for those with ICD)
The data collected from the CathPCI Registry provide
important information on clinical outcomes in a "real-world''
population; more than 1700 institutions currently participate
in the CathPCI Registry, representing over 95% of US
centers performing PCI procedures. All data in the registry
are site-reported; there is no independent adjudication of
adverse events or core lab assessment of angiographic
characteristics. The registry data are comprised
predominantly of in-hospital outcomes.
The Shockwave IVL System with Shockwave C
Catheter continues to demonstrate safety with a low
incidence of procedure-related adverse events including
all-cause death, supporting the absence of unreasonable
risk of illness or injury associated with the use of the device
for its intended uses and conditions of use. These results
confirm the overall safety profile of the Shockwave Medical
Coronary IVL System for the treatment of subjects with
highly calcified lesions in coronary arteries prior to stent
placement.
PAS Cohort
% (n/N)
12.6% (153/1,212)
0.0% (0/153)
0.0% (0/153)
1.3% (2/153)
0.0% (0/153)
7.8% (12/153)
50.0% (6/12)
50.0% (6/12)
0.0% (0/12)
0.0% (0/12)
0.0% (0/6)
Coronary IVL
2
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