All (n = 27) | GLIMGLIN | P | ||
---|---|---|---|---|
Success (n = 13) | Failure (n = 14) | |||
Access | ||||
Ipsilateral | 23 (85.2) | 13 (100) | 10 (71.4) | 0.04* |
Contralateral | 4 (14.8) | 0 (0.0) | 4 (28.6) | 0.04* |
Size of Gladius MG™ | ||||
0.014 inch | 12 (44.4) | 5 (38.5) | 7 (50.0) | 0.55 |
0.018 inch | 15 (55.6) | 8 (61.5) | 7 (50.0) | 0.55 |
Wiring time | ||||
GLIMGLIN (min) | 7.1 ± 6.4 | 6.2 ± 5.6 | 7.9 ± 7.2 | 0.83 |
Total wiring time (min) | 30.5 ± 35.3 | 6.2 ± 5.6 | 53.0 ± 36.5 | < 0.001* |
Wire crossing | ||||
Wire crossing success (%) | 27 (100) | 13 (100) | 14 (100) | > 0.99 |
Conventional wiring success (%) | 20 (74.1) | 13 (100) | 7 (50.0) | 0.03* |
Number of wires for crossing | 1.9 ± 1.1 | 1.0 ± 0.0 | 2.7 ± 1.0 | < 0.001* |
IVUS-guided wiring (%) | 7 (25.9) | 0 (0.0) | 7 (50.0) | 0.03* |
Distal puncture (%) | 2 (7.4) | 0 (0.0) | 2 (14.3) | 0.55 |
Total procedure time (min) | 103.4 ± 35.4 | 80.2 ± 21.7 | 125.0 ± 32.1 | < 0.001* |
Total contrast volume (ml) | 51.1 ± 16.7 | 45.8 ± 13.8 | 56.0 ± 18.1 | 0.15 |
Fluoroscopic time (min) | 36.9 ± 21.1 | 23.6 ± 6.9 | 49.2 ± 22.4 | < 0.001* |
Procedural success (%) | 27 (100) | 13 (100) | 14 (100) | > 0.99 |
Final device | ||||
Drug coated balloon | 14 (51.9) | 5 (38.5) | 9 (64.3) | 0.19 |
Bare nitinol stent | 3 (11.1) | 2 (15.4) | 1 (7.1) | 0.50 |
Drug eluting stent | 9 (33.3) | 6 (46.2) | 3 (21.4) | 0.18 |
Interwoven stent | 1 (3.7) | 0 (0.0) | 1 (7.1) | 0.34 |
Pre ABI | 0.51 ± 0.14 | 0.50 ± 0.18 | 0.53 ± 0.11 | 0.80 |
Post ABI | 0.82 ± 0.23 | 0.93 ± 0.20 | 0.73 ± 0.22 | 0.02* |
Short term outcomes within 30 days | ||||
All cause death | 0 (0.0) | 0 (0.0) | 0 (0.0) | > 0.99 |
Major adverse events | 1 (3.7) | 0 (0.0) | 1 (7.1) | 0.36 |
Major amputation | 1 (3.7) | 0 (0.0) | 1 (7.1) | 0.36 |
Minor amputation | 1 (3.7) | 1 (7.7) | 0 (0.0) | 0.28 |
TLR within 30 days | 0 (0.0) | 0 (0.0) | 0 (0.0) | > 0.99 |
Rutherford classification at 30 days | ||||
0,1 | 20 (74.1) | 9 (69.2) | 11 (78.6) | 0.59 |
2,3 | 1 (3.7) | 0 (0.0) | 1 (7.1) | 0.34 |
4 | 0 (0.0) | 0 (0.0) | 0 (0.0) | > 0.99 |
5,6 | 6 (22.2) | 4 (30.8) | 2 (14.3) | 0.31 |