Evaluation of the MYNX CONTROL™ Arterial Closure System for Achieving Primary Hemostasis after Arterial Femoral Access Following Peripheral Arterial Interventions, Compared to the FemoSealTM Closure System
Abstract
:1. Introduction
2. Methods
2.1. Patient Population
2.2. Study Endpoints
2.3. Endovascular Procedure
3. Statistical Analysis
4. Results
5. Discussion
6. Limitations
7. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviation
References
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Baseline Characteristics | MYNX CONTROL n = 273 | FemoSeal n = 275 | p-Value |
---|---|---|---|
Age, yrs | 72.7 ± 9.5 | 71.5 ± 11.1 | 0.089 |
Male sex | 165 (60.4) | 175 (63.6) | 0.247 |
BMI | 25.6 ± 4.5 | 25.8 ± 4.7 | 0.279 |
Hypertension | 235 (86.1) | 225 (81.8) | 0.107 |
Diabetes mellitus | 125 (45.8) | 113 (41.1) | 0.153 |
Hyperlipidemia | 235 (86.1) | 246 (89.5) | 0.141 |
Smoker | 87 (31.9) | 100 (36.4) | 0.154 |
Former Smoker | 91 (33.3) | 81 (29.5) | 0.188 |
Coronary heart disease | 129 (47.3) | 109 (39.6) | 0.043 |
PCI | 94 (34.4) | 85 (30.9) | 0.215 |
CABG | 27 (9.9) | 21 (7.6) | 0.217 |
CVD | 57 (20.9) | 63 (22.9) | 0.319 |
Stroke | 46 (16.8) | 49 (17.8) | 0.426 |
Renal insufficiency * | 119 (43.6) | 101 (36.7) | 0.060 |
Dialysis | 19 (7) | 11 (4) | 0.092 |
MYNX CONTROL n = 273 | FemoSeal n = 275 | p-Value | |
---|---|---|---|
Creatinine (mg/dL) | 1.44 ± 1.4 | 1.28 ± 1.2 | 0.073 |
Hemoglobin (g/dL) | 13.1 ± 2.1 | 13.0 ± 2.2 | 0.277 |
INR | 1.08 ± 0.22 | 1.07 ± 0.21 | 0.252 |
Thrombocytes (×103/µL) | 255 ± 82 | 272 ± 103 | 0.017 |
Systolic BP (mmHg) | 144.8 ± 21.4 | 148.9 ± 24.8 | 0.020 |
Diastolic BP (mmHg) | 76.9 ± 12.4 | 79.4 ± 14.2 | 0.014 |
MYNX CONTROL n = 273 | FemoSeal n = 275 | p-Value | |
---|---|---|---|
Aspirin permanent medication | 170 (62.3) | 163 (59.7) | 0.299 |
Aspirin loading dose | 37 (13.6) | 41 (15.1) | 0.357 |
Clopidogrel permanent medication | 86 (31.5) | 77 (28.2) | 0.227 |
Clopidogrel loading dose | 181 (67.0) | 176 (64.7) | 0.315 |
Oral anticoagulation | 92 (33.7) | 89 (32.6) | 0.428 |
MYNX CONTROL n = 273 | FemoSeal n = 275 | p-Value | |
---|---|---|---|
Puncture site (right) | 158 (57.9) | 143 (52) | 0.097 |
Prior ipsilateral puncture | 143 (55.2) | 129 (50.6) | 0.168 |
Prior use of a closure device | 129 (49.8) | 119 (46.7) | 0.266 |
Prior use of a closure device in the last 3 months | 25 (9.7) | 23 (23) | 0.462 |
Antegrade | 157 (57.5) | 101 (36.7) | <0.001 |
Introducer Sheath size 5 | 2 (0.7) | 15 (5.5) | 0.001 |
Introducer Sheath size 6 | 264 (96.7) | 251 (91.2) | 0.007 |
Introducer Sheath size 7 | 7 (2.6) | 9 (3.3) | 0.406 |
Lysis | 5 (1.8) | 14 (5.1) | 0.031 |
Calcification CFA | 170 (62.5) | 179 (65.3) | 0.275 |
OR | 95%-CI | p-Value | |
---|---|---|---|
Age (per year) | 1.031 | 0.993–1.071 | 0.106 |
BMI < 25 | 1.639 | 0.822–3.266 | 0.160 |
BMI 25–30 | 0.504 | 0.239–1.064 | 0.072 |
BMI > 30 | 1.332 | 0.513–3.460 | 0.556 |
Female sex | 1.281 | 0.642–2.557 | 0.483 |
Current smoker | 0.733 | 0.339–1.585 | 0.430 |
Former smoker | 1.197 | 0.587–2.442 | 0.621 |
Hypertension | 1.078 | 0.393–2.960 | 0.884 |
Diabetes mellitus | 0.841 | 0.420–1.681 | 0.624 |
Hyperlipidemia | 0.454 | 0.195–1.054 | 0.066 |
Blood dialysis | 0.712 | 0.158–3.215 | 0.659 |
Acetylsalicylic acid | 1.369 | 0.658–2.849 | 0.401 |
Platelet aggregation inhibitors | 0.869 | 0.409–1.845 | 0.715 |
(Non) vitamin K antagonist oral anticoagulants | 0.398 | 0.168–0.944 | 0.036 |
Antegrade puncture | 0.703 | 0.354–1.397 | 0.314 |
Retrograde puncture | 1.423 | 0.716–2.828 | 0.314 |
Previous ipsilateral puncture | 0.834 | 0.416–1.675 | 0.610 |
Previous closure device ipsilateral | 0.947 | 0.472–1.901 | 0.879 |
Lysis | 1.561 | 0.170–14.351 | 0.694 |
Calcification | 1.644 | 0.869–3.111 | 0.126 |
OR | 95%-CI | p-Value | |
---|---|---|---|
Age (per year) | 0.981 | 0.938–1.026 | 0.397 |
BMI < 25 | 1.253 | 0.442–3.558 | 0.671 |
BMI 25–30 | 0.868 | 0.288–2.616 | 0.802 |
BMI > 30 | 0.799 | 0.174–3.669 | 0.772 |
Female sex | 0.621 | 0.192–2.005 | 0.426 |
Current smoker | 1.177 | 0.406–3.410 | 0.764 |
Former smoker | 1.644 | 0.566–4.781 | 0.361 |
Hypertension | 1.472 | 0.321–6.738 | 0.619 |
Diabetes mellitus | 0.704 | 0.234–2.117 | 0.532 |
Hyperlipidemia | 0.444 | 0.118–1.678 | 0.232 |
Blood dialysis | 1.779 | 0.212–14.891 | 0.595 |
Acetylsalicylic acid | 0.355 | 0.116–1.090 | 0.070 |
Platelet aggregation inhibitors | 3.671 | 1.230–10.961 | 0.020 |
(Non) vitamin K antagonist oral anticoagulants | 2.159 | 0.733–6.355 | 0.163 |
Antegrade puncture | 1.158 | 0.400–3.353 | 0.787 |
Retrograde puncture | 0.835 | 0.288–2.420 | 0.740 |
Previous ipsilateral puncture | 2.034 | 0.675–6.127 | 0.207 |
Previous closure device ipsilateral | 1.773 | 0.612–5.136 | 0.291 |
Lysis | 3.179 | 0.644–15.708 | 0.156 |
Calcification | 1.065 | 0.353–3.211 | 0.911 |
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Noory, E.; Böhme, T.; Krause, L.; Ruile, P.; Salm, J.; Beschorner, U.; Bollenbacher, R.; Westermann, D.; Zeller, T. Evaluation of the MYNX CONTROL™ Arterial Closure System for Achieving Primary Hemostasis after Arterial Femoral Access Following Peripheral Arterial Interventions, Compared to the FemoSealTM Closure System. J. Clin. Med. 2023, 12, 5255. https://doi.org/10.3390/jcm12165255
Noory E, Böhme T, Krause L, Ruile P, Salm J, Beschorner U, Bollenbacher R, Westermann D, Zeller T. Evaluation of the MYNX CONTROL™ Arterial Closure System for Achieving Primary Hemostasis after Arterial Femoral Access Following Peripheral Arterial Interventions, Compared to the FemoSealTM Closure System. Journal of Clinical Medicine. 2023; 12(16):5255. https://doi.org/10.3390/jcm12165255
Chicago/Turabian StyleNoory, Elias, Tanja Böhme, Leonie Krause, Philipp Ruile, Jonas Salm, Ulrich Beschorner, Roaa Bollenbacher, Dirk Westermann, and Thomas Zeller. 2023. "Evaluation of the MYNX CONTROL™ Arterial Closure System for Achieving Primary Hemostasis after Arterial Femoral Access Following Peripheral Arterial Interventions, Compared to the FemoSealTM Closure System" Journal of Clinical Medicine 12, no. 16: 5255. https://doi.org/10.3390/jcm12165255
APA StyleNoory, E., Böhme, T., Krause, L., Ruile, P., Salm, J., Beschorner, U., Bollenbacher, R., Westermann, D., & Zeller, T. (2023). Evaluation of the MYNX CONTROL™ Arterial Closure System for Achieving Primary Hemostasis after Arterial Femoral Access Following Peripheral Arterial Interventions, Compared to the FemoSealTM Closure System. Journal of Clinical Medicine, 12(16), 5255. https://doi.org/10.3390/jcm12165255