Figure 1a XableCath (blunt-type)
Figure 1b XableCath (abrasive-type)
Figure 1a XableCath (blunt-type)
Figure 1b XableCath (abrasive-type)
Figure 2a Calcified balloon-uncrossable lesion
Figure 2b XableCath 0.018’’
Figure 2c After XableCath recanalization
Figure 2d After DES-balloon angioplasty
Table 1 Baseline characteristics and lesion data |
||
Variables |
n = 22 (24 lesions) |
|
Female |
11 (50.0%) |
|
Age (years) |
75.3 ± 16.7 (54–93) |
|
Diabetes Mellitus |
16 (72.7%) |
|
Hyperlipidemia |
17 (77.3%) |
|
Hypertension |
18 (81.8%) |
|
Glomerular filtration rate (GFR) ml |
51.0 ± 26.4 (32–80) |
|
Left ventricular ejection fraction (LVEF) |
51.3 ± 15.6 (40–65) |
|
PAD (Rutherford 3/4) |
14 (63.6%) |
|
(Rutherford 5/6) |
8 (36.4%) |
|
Lesion characteristics |
|
|
Femoro-popliteal |
21 (87.5%) |
|
Common iliac |
1 |
|
Below the knee |
2 |
|
Lesion length (mm) |
56 ± 38 |
|
calcification |
20 (83.3%) |
|
total occlusions |
13 (54.2%) |
|
balloon-access-failures |
24 (100%) |
|
Table 2 XableCath Procedure Data |
|
Number of lesions |
24 |
XableCath application-technique |
|
subintimal |
1 |
intraluminal |
23 |
XableCath catheter |
|
0.035’’ |
16 |
0.018’’ |
8 |
Blunt-type |
24 |
Abrasive-type |
4 |
XableCath passes |
1.8 ± 0.8 (1– 3) |
XableCath procedure time (min) |
8.2 ± 4.1 (3–14) |
Adjunctive PTA |
23 (95.8%) |
Table 3 Results |
|
Number lesions treated |
24 |
Primary Procedure success |
23 (95.8%) |
Secondary Procedure success |
24 (100%) |
Minimum lumen diameter (mm) |
|
At baseline |
0.2 ± 0.1 |
After XableCath |
2.4± 1.0 |
After adjunctive POBA/Stent |
4.1 ± 1.8 |
Antegrade vessel flow (TIMI grade) |
|
At baseline |
0.7 ± 0.3 |
After XableCath +adj. POBA |
2.9 ± 0.7 |
Table 4 Procedure-related Complications |
|
Number occlusions treated |
24 |
Perforations |
0 ( 0%) |
Dissections |
4 (16.7%) |
Major (NHLBI type C or greater) |
0 ( 0%) |
Minor (NHLBI type A or B) |
4 (16.7%) |
Acute shunt re-closure |
0 ( 0%) |
Peripheral embolization |
0 ( 0%) |
Major access complications |
0 ( 0%) |