Spectranetics SLS II Mode D'emploi page 5

Results:
Table 3. Principal E ectiveness and Safety Results
Laser vs. Non-Laser
E ectiveness: Leads
~ N
Of First Treatment 244
Of Crossover Treatment ~
Of Final Treatment 244
Total Proc. Time 244
Safety Results: Patients Nª
Acute Complications 218
Complications 1mo. 218
Death, perioperative 218
Death 1mo. 218
Total Proc. Time (mean s.d.) = procedure time for First Treatment + time for Crossover Treatment (if any)
±
CI = Con dence intervals via binomial approximation (E ectiveness) or exact binomial method (Safety)
* = di erence statistically signi cant (p < 0.001) by Chi-Square with continuity correction, or t-test
a includes patients randomized to LASER plus Crossover patients
b includes patients randomized to NonLASER less Crossover patients
Di erence = LASER-NonLASER; SEM = sqrt(p1*q1/n1 + p2*q2/n2); 95% CI = Di
7.2 Registry Trial
Purpose: Registry usage of the 14F and 16F laser sheaths to explant chronically implanted pacing and de brillator leads was compared to the outcomes of the 12F laser sheath randomized study.
Primary e ectiveness measure was the proportion of complete extractions (per lead). The primary safety measure was complication rate (per patient).
Methods: Patients with mandatory or necessary indications for lead removal and with the targeted lead implanted at least one year prior were treated at 32 US centers between 6/97 and 2/98. 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 four events occurred: change to femoral or transatrial approach, failure to gain venous entry, failure of sheaths to pass a binding site, or onset of
complication. 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: 180 registry patients were enrolled and treated (97 for 14F, 83 for 16F). Mean patient age for the 14F group was 69 years (range 13 to 86) with 57% males; this did not di er
signi cantly from the 12F randomized group. Implant duration of leads treated with the 14F device was signi cantly longer than the control group (85
mean patient age was 62 years (range 9 to 85) with 77% males; these values were also not signi cantly di erent from the control group. Implant duration of leads treated with the 16F device was 68
months and was not signi cantly di erent from the control group.
Results:
Table 4. Principal E ectiveness and Safety Results
14F vs. 12F
E ectiveness: leads N
Outcome 164
Safety: patients N
Acute Complications 97
Complications, 1 mo. 78
Death, perioperative 97
Death, 1 mo. 78
E ectiveness: leads N
Outcome 244
Safety: patients N
Acute Complications 218
Complications, 1 mo. 218
Death, perioperative 218
Death, 1 mo. 218
Table 5. Principal E ectiveness and Safety Results
16F vs. 12F
E ectiveness: leads N
Outcome 97
Safety: patients N
Acute Complications 83
Complications, 1 mo. 72
Death, perioperative 83
Death, 1 mo. 72
E ectiveness: leads N
Outcome 244
Safety: patients N
Acute Complications 218
Complications, 1 mo. 218
Death, perioperative 218
Death, 1 mo. 218
P002674-12 21OCT20 (2020-10-21)
SLS™II Laser Sheath
Laser
Complete Partial
230 (94.3%) 6 (2.4%)
~ ~
230 (94.3%) 6 (2.4%)
11.2 ±13.9 min
Laser
3 (1.4%) [0.3%, 4.0%]
6 (2.8%) [1.0%, 5.9%]
1 (0.5%) [0.0%, 2.5%]
2 (0.9%) [0.1%, 3.3%]
1.96*SEM
±
14F
Complete
142 (86.6%)
Observed
4 (4.1%)
2 (2.6%)
2 (2.1%)
1 (1.3%)
12F
Complete
230 (94.3%)
Observed
3 (1.4%)
6 (2.8%)
1 (0.5%)
2 (0.9%)
16F
Complete
86 (88.7%)
Observed
5 (6.0%)
0 (0.0%)
1 (1.2%)
0 (0.0%)
12F
Complete
230 (94.3%)
Observed
3 (1.4%)
6 (2.8%)
1 (0.5%)
2 (0.9%)
Failure N Complete
8 (3.3%) 221 142 (64.2%)
~ 72 63 (87.5%)
8 (3.3%) 221 205 (92.8%)
~ 221 14.2
N
b
83
83
83
83
Partial
12 (7.3%)
Con dence Interval
[0.2%, 8.1%]
[0.0%, 6.1%]
[0.0%, 4.9%]
[0.0%, 3.8%]
Partial
6 (2.5%)
Con dence Interval
[0.3%, 4.0%]
[1.0%, 5.9%]
[0.0%, 2.5%]
[0.1%, 3.3%]
Partial
2 (2.1%)
Con dence Interval
[0.9%, 11.1%]
[0.0%, 0.0%]
[0.0%, 3.6%]
[0.0%, 0.0%]
Partial
6 (2.5%)
Con dence Interval
[0.3%, 4.0%]
[1.0%, 5.9%]
[0.0%, 2.5%]
[0.1%, 3.3%]
Instructions for Use
English / English
Non-Laser
Partial Failure
4 (1.9%) 75 (33.9%)
3 (4.2%) 6 (8.3%)
7 (3.1%) 9 (4.1%)
±21.6 min ~
Non-Laser
0 (0.0%) [0.0%, 4.4%]
1 (1.2%) [0.0%, 6.5%]
0 (0.0%) [0.0%, 4.4%]
1 (1.2%) [0.0%, 6.5%]
50 months vs. 65 42 months). For the 16F group
± ±
Failure
10 (6.1%)
Di erence in Failure
Failure
8 (3.3%) 2.8% [-1.5%, 7.1%]
Di erence[95% CI]
2.7% [-2.2%, 7.7%]
1.6% [-2.1%, 5.3%]
1.6% [-2.1%, 5.3%]
0.4% [-3.3%, 4.0%]
Failure
9 (9.3%)
Di erence in Failure
Failure
8 (3.3%) 6.0% [-0.2%, 12.2%]
Di erence[95% CI]
4.6% [-1.5%, 10.8%]
-2.8% [-5.8%, 0.3%]
0.7% [-2.6%, 4.1%]
-0.9% [-3.1%, 1.3%]
Di erence In
Failure [95% CI]
-29.8%* [-23%,-36%]
~
-0.8% [-2.8%,4.2%]
-3.05* [-3.12,-2.97]
Di erence
1.4% [-0.2%, 2.9%]
1.5% [-1.7%, 4.7%]
0.5% [-0.3%, 1.1%]
-0.3% [-3.0%, 2.4%]
60
±
[95% CI]
[95% CI]
5