| Literature DB >> 35861944 |
Eiji Karashima1, Yoshimitsu Soga2, Takeshi Arima3, Hirotaka Noda3, Shioto Yasuda3, Takeo Kaneko3.
Abstract
BACKGROUND: To evaluate the efficacy of the GLadIus MG drilLINg technique (GLIMGLIN), a novel initial wiring technique using the Gladius MG™ structural features, for crossing the superficial femoral artery (SFA) with chronic total occlusion (CTO).Entities:
Keywords: Chronic total occlusion; Endovascular therapy; Femoropopliteal artery disease; Peripheral arterial disease
Year: 2022 PMID: 35861944 PMCID: PMC9304519 DOI: 10.1186/s42155-022-00313-2
Source DB: PubMed Journal: CVIR Endovasc ISSN: 2520-8934
Fig. 1Scheme of the round core and pictures in the CTO model of Gladius MG™. a Because the tip of the round core is narrowing, the Gladius MG™ has two bending points. (B-E) A 0.018-inch Gladius MG™ was inserted into the soft gel of the CTO model. b The tip of the Gladius MG™ was attached to the hard gel. c The Gladius MG™ was pushed further after the tip was attached to the hard gel; the first point was bending. d The Gladius MG™ was pushed further after being bent the first point, the second point began to bend. e When the Gladius MG™ was pushed more after bending at the second point, the Gladius MG™ was advanced into the soft gel with a looped shape. The bending point of the looped shape Gladius MG™ was the second point. f When the tip and the first point of the 0.014-inch Gladius MG™ advanced into the hard gel, on pushing the wire further, the second point began to bend
Fig. 2The study flowchart. During the study, the 34 symptomatic PAD patients with de novo SFA CTO performed EVT, and the 27 patients were included to the study. In those, conventional wiring and GLIMGLIN were succeeded in 20 and 13 patients, respectively
Fig. 3A representative case of GLIMGLIN. a A computed tomographic angiography revealed a right SFA CTO. Angiography of pre-EVT (b), after the wire crossing (c), and post EVT (d). e-k Shapes of a 0.018-inch Gladius MG™ during GLIMGLIN. When the first point was bending (g, h), the wire pulled back (i). The wire was rotated to select a different route for its advancement without bending at the first and second points (j, k)
Patient characteristics
| All ( | GLIMGLIN | |||
|---|---|---|---|---|
| Success ( | Failure ( | |||
| Age, years | 77.4 ± 8.5 | 74.5 ± 7.6 | 80.0 ± 8.6 | 0.14 |
| Male, n (%) | 20 (74.1) | 11 (84.6) | 9 (64.3) | 0.24 |
| Body mass index, kg/m2 | 21.9 ± 3.7 | 21.5 ± 4.0 | 22.3 ± 3.4 | 0.42 |
| Hypertension, n (%) | 26 (96.3) | 12 (92.3) | 14 (100) | 0.30 |
| Dyslipidemia, n (%) | 15 (55.6) | 4 (30.8) | 11 (78.6) | 0.01* |
| Diabetes, n (%) | 13 (48.1) | 6 (46.2) | 7 (50.0) | 0.85 |
| Smoking, n (%) | 25 (92.6) | 12 (92.3) | 13 (92.9) | 0.96 |
| Coronary artery disease, n (%) | 8 (29.6) | 4 (30.8) | 5 (35.7) | 0.79 |
| Cerebrovascular disease, n (%) | 7 (25.9) | 2 (15.4) | 5 (35.7) | 0.24 |
| Atrial fibrillation, n (%) | 7 (25.9) | 3 (23.1) | 4 (28.6) | 0.75 |
| Heart failure, n (%) | 8 (29.6) | 4 (30.8) | 4 (28.6) | 0.90 |
| eGFR < 60, n (%) | 18 (66.7) | 8 (61.5) | 10 (71.4) | 0.59 |
| Haemodialysis, n (%) | 3 (11.1) | 1 (7.7) | 2 (14.3) | 0.59 |
| Rutherford classification | ||||
| 2,3 | 13 (48.1) | 8 (61.5) | 6 (42.9) | 0.34 |
| 4 | 7 (25.9) | 1 (7.7) | 5 (35.7) | 0.09 |
| 5,6 | 7 (25.9) | 4 (30.8) | 3 (21.4) | 0.59 |
*P < 0.05, Values are expressed as mean ± standard deviation or number (percentage)
Procedural characteristics
| All ( | GLIMGLIN | |||
|---|---|---|---|---|
| Success ( | Failure ( | |||
| 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 |
*P < 0.05, Values are expressed as mean ± standard deviation or number (percentage)
Lesion characteristics
| All ( | GLIMGLIN | |||
|---|---|---|---|---|
| Success ( | Failure ( | |||
| Angiography findings | ||||
| Lesion length (cm) | 23.6 ± 8.0 | 23.3 ± 7.5 | 23.9 ± 8.8 | 0.73 |
| CTO length (cm) | 16.1 ± 8.9 | 15.6 ± 8.4 | 16.6 ± 9.7 | 0.80 |
| CTO < 5 cm | 4 (14.8) | 2 (15.4) | 2 (14.3) | 0.98 |
| CTO 5 ~ 15 cm | 9 (33.3) | 5 (38.5) | 4 (28.6) | 0.06 |
| CTO > 15 cm | 14 (51.9) | 6 (46.2) | 8 (57.1) | 0.58 |
| Proximal RVD | 5.9 ± 0.9 | 6.3 ± 0.8 | 5.5 ± 0.9 | 0.02* |
| Distal RVD | 5.6 ± 0.6 | 5.9 ± 0.5 | 5.4 ± 0.6 | 0.02* |
| PACSS grade | ||||
| 0 | 12 (44.4) | 8 (61.5) | 4 (28.6) | 0.09 |
| 1 | 4 (14.8) | 1 (7.7) | 3 (21.4) | 0.33 |
| 2 | 5 (18.5) | 1 (7.7) | 4 (28.6) | 0.17 |
| 3 | 2 (7.4) | 1 (7.7) | 1 (7.1) | 0.96 |
| 4 | 4 (14.8) | 2 (15.4) | 2 (14.3) | 0.94 |
| Below-the-knee run-off | ||||
| 0 | 4 (14.8) | 2 (15.4) | 2 (14.3) | 0.94 |
| 1 | 5 (18.5) | 4 (30.8) | 1 (7.1) | 0.12 |
| 2 | 11 (40.7) | 4 (30.8) | 7 (50.0) | 0.32 |
| 3 | 7 (25.9) | 3 (23.1) | 4 (28.6) | 0.75 |
| IVUS findings | ||||
| Complete true lumen passage | 22 (81.5) | 13 (100) | 9 (64.3) | 0.02* |
| Proximal EEM | 39.1 ± 9.6 | 39.1 ± 11.1 | 39.0 ± 8.4 | 0.88 |
| Distal EEM | 29.6 ± 9.7 | 29.3 ± 9.0 | 29.8 ± 10.6 | 0.92 |
| Calcium angle | ||||
| 0 ~ 90° | 8 (29.6) | 5 (38.5) | 3 (21.4) | 0.34 |
| 91 ~ 180° | 5 (18.5) | 4 (30.8) | 1 (7.1) | 0.12 |
| 181 ~ 270° | 8 (29.6) | 2 (15.4) | 6 (42.9) | 0.13 |
| 271 ~ 360° | 6 (22.2) | 2 (15.4) | 4 (28.6) | 0.42 |
| Calcium angle > 180° | 14 (51.9) | 4 (30.8) | 10 (71.4) | 0.04* |
*P < 0.05, Values are expressed as mean ± standard deviation or number (percentage)