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6.
Adverse Events
6.1
Observed Adverse Events
Adverse events observed for the 12F, 14F, and 16F Laser Sheaths in clinical studies are reported in Tables 1 and 2 below. Table 1 reports adverse event information from the 301-patient randomized study
of lead removal with the 12F Device (LASER) and conventional lead extraction tools (Non-LASER). Table 2 reports adverse event information from a 180-patient registry study of lead removal with the 14F
And 16F devices. Adverse event rates for the 12F device from the randomized study is included in Table 2 for comparison to the larger devices.
Table 1. Acute Complications and Complications at 1-month
All Randomized Patients (n=301)
Laser Device: 12F
Complications – Acute
Perioperative Death
Hemopericardium tamponade
Hemothorax
Complications – One Month
Death
Complications – any
Pain at cut-down site
Arm swelling
Infection
SVC thrombosis
Tricuspid regurgitation
Table 2. Acute Complications and Complications at 1-month
Laser-Treated Patients: 14F, 16F, and 12F Devices
Complications – Acute
Perioperative Death
Hemopericardium tamponade
Hemothorax
Perforation
Other
Complications – One Month
Death
Complications – any
Pain at cut-down site
Arm swelling
Infection
Tricuspid regurgitation
Phlebitis
6.2
Potential Adverse Events
The following adverse events or conditions may also occur during lead extraction with the Laser Sheath, but were not observed during the clinical study (listed in alphabetical order):
•
bacteremia
•
low cardiac output
•
migration of lead fragments
•
migration of vegetation
•
myocardial avulsion / perforation
•
premature ventricular contractions
•
pulmonary embolism
•
stroke
•
venous avulsion / perforation
•
ventricular tachycardia
7.
Clinical Study
The Laser Sheaths in these studies were used with the CVX-300® Excimer Laser System. The Philips Laser System provides the same output and operates at the same parameters as the CVX-300® Excimer
Laser System; therefore, no new clinical data has been collected for the Laser Sheath with the Philips Laser System.
7.1
Randomized Trial
Purpose: The use of standard tools (NonLASER) only (locking stylets, polymer and stainless steel sheaths, grips, snares, etc.) to explant chronically implanted pacing and de brillator leads was compared
to standard tools plus the 12F laser sheath (LASER). The primary e ectiveness measure was the proportion of complete extractions (per lead basis). The primary safety measure was complication rate
(per patient basis).
Methods: Patients with mandatory or necessary indications for lead removal and with the targeted lead implanted at least one year prior were randomized into the LASER or NonLASER groups in nine
US centers between 11/95 and 10/96. The primary endpoint was reached if the lead was completely explanted. If the lead fractured, leaving the tip and possibly a portion of the conductor in the patient,
the removal was judged a "partial success. " The extraction was judged a procedural failure if any of ve events occurred: change to femoral or transatrial approach, failure to gain venous entry, failure of
sheaths to pass a binding site, lead breakage, or onset of complication. A crossover from NonLASER tools to laser tools was allowed after failure. Crossover patients were analyzed separately. Procedure
time, de ned as wall-clock time from the moment sheaths were applied until an endpoint was reached, was also recorded.
Description of Patients: 365 patients were enrolled. Five patients were found to meet exclusion criteria after enrollment and were disquali ed from the study before any treatment was administered;
thus 360 patients were treated. 59 nonrandomized patients were enrolled for investigator training. The remaining 301 patients (with 465 leads) presented with mandatory or necessary indications for
lead removal. Mean patient age was 65 years (range 4 to 94) with 36% females and mean implant duration of 67 months (range 1 to 286). Patient characteristics were similar between the two randomized
groups.
P002674-12
21OCT20
(2020-10-21)
SLS™II Laser Sheath
LASER (N=153)
n
%
1
0.7%
2
1.3%
1
0.7%
LASER (N=145)
2
1.4%
4
2.8%
1
0.7%
1
0.7%
1
0.7%
0
0.0%
1
0.7%
14F (N=97)
16F (N=83)
n
%
n
2
2.1%
1
3
3.1%
3
0
0%
0
0
0%
1
1
1.0%
1
14F (N=78)
16F (N=72)
n
%
n
1
1.3%
0
2
2.6%
0
0
0%
0
1
1.3%
0
0
0%
0
0
0%
0
1
1.3%
0
Instructions for Use
Non-LASER (N=148)
n
%
0
0
0
0
0
0
Non-LASER (N=140)
1
0.7%
3
2.1%
0
0.0%
1
0.7%
1
0.7%
1
0.7%
0
0.0%
12F (N=153)
%
n
%
1.2%
1
0.7%
3.6%
2
1.3%
0%
1
0.7%
1.2%
0
0%
1.2%
0
0%
12F (N=145)
%
n
%
0%
2
1.4%
0%
4
2.8%
0%
1
0.7%
0%
1
0.7%
0%
1
0.7%
0%
1
0.7%
0%
0
0%
English / English
TOTAL (N=301)
n
%
1
0.3%
2
0.7%
1
0.3%
TOTAL (N=285)
3
1.1%
7
2.5%
1
0.4%
2
0.7%
2
0.7%
1
0.4%
1
0.4%
TOTAL (N=333)
n
%
4
1.2%
8
2.4%
1
0.3%
1
0.3%
2
0.6%
TOTAL (N=295)
n
%
3
1.0%
6
2.0%
1
0.3%
2
0.7%
1
0.3%
1
0.3%
1
0.3%
4
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