Safety and Efficacy of Prestige Coils for Embolization of Vascular Abnormalities: The Embo-Prestige Study
Abstract
:1. Introduction
2. Patients and Methods
2.1. Study Design and Patients
2.2. Embolization Agents and Procedure
2.3. Follow-Up
2.4. Study Endpoints
2.5. Statistical Analysis
3. Results
3.1. Patients
3.2. Embolization Data
3.3. Prestige Coils Characteristics
3.4. Immediate Efficacy
3.5. One-Month Efficacy
3.6. Safety
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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n (%) | Series 1 (n = 110) | Series 2 (n = 110) | Total (n = 220) | p-Values |
---|---|---|---|---|
Age * | 64.5 (38.3–73.0) | 59.0 (34.0–71.8) | 62.5 (35.8–73) | 0.13 |
Gender | ||||
Male | 71 (64.5) | 78 (70.9) | 149 (67.7) | 0.31 |
Female | 39 (35.5) | 32 (29.1) | 71 (32.3) | |
Comorbidities | 0.011 | |||
Diabetes | 13 (11.7) | 7 (6.4) | 20 (9.1) | |
Arterial hypertension | 47 (42.3) | 31 (28.2) | 78 (35.5) | |
Cirrhosis | 4 (3.6) | 2 (1.8) | 6 (2.7) | |
Performance status | 0.14 | |||
0 | 50 (45.9) | 65 (59.6) | 115 (52.8) | |
1 | 37 (33.9) | 25 (22.9) | 62 (28.4) | |
2 | 14 (12.8) | 15 (13.8) | 29 (13.3) | |
3 | 3 (2.8) | 3 (2.8) | 6 (2.8) | |
4 | 5 (4.6) | 1 (0.9) | 6 (2.8) | |
Missing | 1 | 1 | 2 | |
Previous treatments | 0.006 | |||
Anti-coagulant | 24 (21.6) | 11 (10.0) | 35 (15.9) | |
Anti-platelet | 25 (22.5) | 16 (14.5) | 41 (18.6) |
n (%) | Series 1 (n = 110) | Series 2 (n = 110) | Total (n = 220) | p-Values |
---|---|---|---|---|
Risk of the procedure | 0.16 | |||
Low | 42 (38.2) | 36 (32.7) | 78 (35.5) | |
Medium | 48 (43.6) | 42 (38.2) | 90 (40.9) | |
High | 20 (18.2) | 32 (29.1) | 52 (23.6) | |
Vascular anomaly | 0.08 | |||
Arterial | 89 (80.9) | 78 (70.0) | 167 (75.9) | |
Venous (variquous) | 20 (18.2) | 32 (29.1) | 52 (23.6) | |
Other | 1 (0.9) | 0 | 1 (0.05) | |
Arterial anomalies | 0.21 | |||
Aneurism | 21 (23.6) | 10 (14.3) | 31 (21.1) | |
Faux aneurism | 18 (20.2) | 19 (27.1) | 37 (25.2) | |
Bleeding | 29 (32.6) | 36 (51.4) | 65 (44.2) | |
Arteriovenous fistula | 4 (4.5) | 3 (4.3) | 7 (4.8) | |
Malformation | 5 (5.6) | 2 (2.9) | 7 (4.8) | |
Missing | 12 | 8 | 19 | |
Embolized artery | ||||
Hepatic artery | 3 (3.5) | |||
Splenic artery | 13 (15.1) | |||
Superior mesenteric artery | 4 (4.7) | |||
Inferior mesenteric artery | 4 (4.7) | NA | NA | |
Left gastric artery | 1 (1.2) | |||
Gastroduodenal artery | 5 (5.8) | |||
Hypogastric artery | 13 (15.1) | |||
Renal artery | 13 (15.1) | |||
Other | 30 (34.9) | |||
Missing | 3 | |||
Embolized vein | ||||
Spermatic vein | 16 (80.0) | |||
Ovarian vein | 1 (5.0) | NA | NA | |
Other | 3 (15.0) | |||
Size of the vascular anomaly * | 6 (4–14) | 6 (5–10) | 6 (4–12) | 0.056 |
Missing | 0 | 1 | 1 | |
Size of the occluded vessel * | 4 (3–6) | 5 (3–6) | 5 (3–6) | 0.038 |
n (%) | Series 1 (n = 110) | Series 2 (n = 110) | Total (n = 220) | p-Values |
---|---|---|---|---|
Embolization agent used | ||||
Prestige coils | 110 (100) | 0 | 110 (50) | |
Other coils | 16 (14.5) | 49 (44.5) | 65 (29.5) | |
Liquid agent | 24 (21.8) | 50 (45.5) | 74 (33.6) | |
Spongel | 6 (5.5) | 16 (14.5) | 22 (10.0) | |
Microparticles | 3 (2.7) | 7 (6.4) | 10 (4.5) | |
Plug | 3 (2.7) | 16 (14.5) | 19 (8.6) | |
Number of coils used ** | 0.11 | |||
0–9 | 89 (80.9) | 45 (93.8) | 134 (84.8) | |
10–29 | 17 (15.5) | 3 (6.3) | 20 (12.7) | |
30–50 | 4 (3.6) | 0 | 4 (2.5) | |
Missing | 0 | 1 | 1 | |
Length of the first coil pushed ** | 0.4 | |||
≤15 cm | 63 (57.3) | 26 (54.2) | 89 (56.3) | |
15–30 cm | 27 (24.5) | 9 (18.8) | 36 (22.8) | |
>30 cm | 20 (18.2) | 13 (27.1) | 33 (20.9) | |
Missing | 0 | 1 | 1 | |
Diameter of the first coil pushed ** | 0.31 | |||
<6 mm | 65 (59.1) | 26 (55.3) | 91 (58.0) | |
6–10 mm | 27 (24.5) | 17 (36.2) | 44 (28.0) | |
11–20 mm | 13 (11.8) | 2 (4.3) | 15 (9.6) | |
≥20 mm | 5 (4.5) | 2 (4.3) | 7 (4.5) | |
Missing | 0 | 2 | 2 | |
Microcatheter size | <0.001 | |||
≤2.0 fr | 12 (11.2) | 5 (4.9) | 17 (8.1) | |
2.4 fr | 52 (48.6) | 18 (17.5) | 70 (33.3) | |
≥2.7 fr | 43 (40.2) | 80 (77.7) | 123 (58.6) | |
Missing | 3 | 7 | 10 | |
Scopy time * | 25 (16–39) | 17.5 (10–30) | 22 (13–37) | 0.015 |
Missing | 2 | 10 | 12 | |
Radiation dose * | 47,060 (23,637–115,621) | 34,385 (18,077–98,077) | 39,470 (19,550–107,878) | 0.26 |
Missing | 3 | 10 | 10 |
n (%) | Series 1 (n = 110) |
---|---|
Flexibility of the coil | |
Very flexible | 61 (55.5) |
Flexible | 49 (44.5) |
Rigid | 0 |
Very rigid | 0 |
Pushability | |
Very easy to push | 61 (55.5) |
Easy to push | 47 (42.7) |
Difficult to push | 2 (1.8) |
Very difficult to push | 0 |
Packing density | |
Not dense at all | 2 (1.8) |
A little dense | 17 (15.6) |
Quite dense | 56 (51.4) |
Very dense | 34 (31.2) |
Missing | 1 |
n (%) | Series 1 (n = 110) | Series 2 (n = 110) | Total (n = 220) | p-Values |
---|---|---|---|---|
Correct positioning of the coil/embolization agent | ||||
Prestige coil | 110 (100) | NA | ||
Other coils * | 15 (13.6) | 46 (41.8) | ||
Liquid agent * | 24 (21.8) | 49 (44.5) | ||
Spongel * | 6 (5.5) | 15 (13.6) | NA | |
Microparticles * | 2 (1.8) | 7 (6.4) | ||
Plug * | 3 (2.7) | 15 (13.6) | ||
Complete occlusion of the target vessel | 106 (96.4) | 109 (99.1) | 215 (97.7) | 0.17 |
Confidence of the radiologist in his/her procedure | 0.04 | |||
Not very confident | 1 (0.9) | 0 | 1 (0.5) | |
A bit confident | 1 (0.9) | 1 (0.9) | 2 (0.9) | |
Confident | 53 (48.2) | 70 (63.6) | 123 (55.9) | |
Very confident | 55 (50.0) | 39 (35.5) | 94 (42.7) |
n (%) | Series 1 (n = 105) | Series 2 (n = 99) | Total (n = 204) | p-Values |
---|---|---|---|---|
Lost to follow-up/missing | 5 | 11 | 16 | 0.12 |
Improvement | 83 (79.0) | 74 (74.7) | 157 (77.0) | 0.99 |
Steady state | 1 (1.0) | 1 (1.0) | 2 (1.0) | 0.97 |
Back to baseline state | 16 (15.2) | 18 (18.2) | 34 (16.7) | 0.57 |
Aggravation Incl death | 6 (5.7) 5 (4.8) | 6 (6.1) 5 (5.1) | 12 (5.9) 10 (5.4) | 0.92 |
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Frandon, J.; Loffroy, R.; Marcelin, C.; Vernhet-Kovacsik, H.; Greffier, J.; Dabli, D.; Sammoud, S.; Marek, P.; Chevallier, O.; Beregi, J.-P.; et al. Safety and Efficacy of Prestige Coils for Embolization of Vascular Abnormalities: The Embo-Prestige Study. J. Pers. Med. 2023, 13, 1464. https://doi.org/10.3390/jpm13101464
Frandon J, Loffroy R, Marcelin C, Vernhet-Kovacsik H, Greffier J, Dabli D, Sammoud S, Marek P, Chevallier O, Beregi J-P, et al. Safety and Efficacy of Prestige Coils for Embolization of Vascular Abnormalities: The Embo-Prestige Study. Journal of Personalized Medicine. 2023; 13(10):1464. https://doi.org/10.3390/jpm13101464
Chicago/Turabian StyleFrandon, Julien, Romaric Loffroy, Clement Marcelin, Hélène Vernhet-Kovacsik, Joel Greffier, Djamel Dabli, Skander Sammoud, Pierre Marek, Olivier Chevallier, Jean-Paul Beregi, and et al. 2023. "Safety and Efficacy of Prestige Coils for Embolization of Vascular Abnormalities: The Embo-Prestige Study" Journal of Personalized Medicine 13, no. 10: 1464. https://doi.org/10.3390/jpm13101464
APA StyleFrandon, J., Loffroy, R., Marcelin, C., Vernhet-Kovacsik, H., Greffier, J., Dabli, D., Sammoud, S., Marek, P., Chevallier, O., Beregi, J. -P., & Rousseau, H. (2023). Safety and Efficacy of Prestige Coils for Embolization of Vascular Abnormalities: The Embo-Prestige Study. Journal of Personalized Medicine, 13(10), 1464. https://doi.org/10.3390/jpm13101464