Effectiveness of a Real-Time X-ray Dosimetry Monitor in Reducing Radiation Exposure in Coronary Procedures: The ESPRESSO-Raysafe Randomized Trial
Abstract
:1. Introduction
2. Material and Methods
2.1. Study Design
2.2. Hypothesis of the Study
2.3. Measurement of Scattered Radiation
2.4. Statistical Analysis
3. Results
3.1. Patient and Procedural Characteristics
3.2. Radiation Exposure
4. Discussion
4.1. Radiation Exposure in Interventional Cardiology and Interpretation of the Present Findings
4.2. Limitations
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Trial Registration
References
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Control | Monitor | All Procedures | p | |
---|---|---|---|---|
n (%)/Median [IQR] | n (%)/Median [IQR] | n (%)/Median [IQR] | ||
Procedures, total | 331 (47%) | 369 (53%) | 700 (100%) | |
PCI | 176 (53.2%) | 175 (47.4%) | 347 (51.1%) | 0.172 |
LV Angiography | 146 (44.1%) | 148 (40.1%) | 294 (42.8%) | 0.355 |
FFR/iFR | 27 (8.2%) | 19 (5.1%) | 46 (6.7%) | 0.153 |
OCT | 9 (2.7%) | 9 (2.4%) | 18 (2.6%) | 0.984 |
Recanalization of chronic total occlusions | 3 (0.9%) | 3 (0.8%) | 6 (0.9%) | 0.776 |
Rotablation | 1 (0.3%) | 5 (1.4%) | 6 (0.9%) | 0.269 |
Right heart catheterization | 13 (3.9%) | 20 (5.4%) | 33 (4.8%) | 0.440 |
Biopsy | 12 (3.6%) | 10 (2.7%) | 22 (3.2%) | 0.654 |
Male Patient | 220 (66.5%) | 239 (64.8%) | 459 (65.6%) | 0.763 |
Unstable angina | 58 (17.5%) | 56 (15.2%) | 114 (16.6%) | 0.485 |
NSTEMI | 51 (15.4%) | 66 (17.9%) | 127 (17.0%) | 0.414 |
STEMI | 47 (14.2%) | 41 (11.1%) | 88 (12.8%) | 0.278 |
Hyperlipoproteinemia | 177 (53.5%) | 197 (53.4%) | 374 (54.4%) | 0.997 |
Dialyse | 8 (2.4%) | 14 (3.8%) | 22 (3.2%) | 0.400 |
BMI [Kg/m²] | 26.6 (24.3–29.4) | 26.1 (24.2–28.3) | 26.2 (24.2–29.1) | 0.232 |
Access radial left | 20 (6.0%) | 19 (5.1%) | 39 (5.7%) | 0.743 |
Group | ||||
---|---|---|---|---|
Control | Monitor | All Procedures | p | |
Median [IQR] | Median [IQR] | Median [IQR] | ||
Contrast medium [mL] | 100 (61–151) | 92.5 (61–163) | 93 (61–156) | 0.817 |
Fluoroscopy time [min] | 7.0 (6.1–7.7) | 5.6 (5.1–6.2) | 6.1 (3.2–10.7) | 0.028 |
Dose-Area product, cGy·cm2 | 21.8 (12.5–40.2) | 18.8 (16.2–21.6) | 20.0 (11.4–36.4) | 0.027 |
Dosimeter (E, first operator) [µSv] | 9.9 (3.8–19.9) | 9.0 (3.5–19.2) | 9.2 (3.5–19.7) | 0.700 |
Dosimeter (E, assistant operator) [µSv] | 1.9 (0.7–4.1) | 1.6 (0.6–3.6) | 1.7 (0.6–3.8) | 0.121 |
Dosimeter (E, nurse) [µSv] | 0.20 (0.10–0.36) | 0.17 (0.08–0.31) | 0.18 (0.09–0.33) | 0.012 |
Dosimeter (E, patient) [µSv] | 208 (87–455) | 135 (68–318) | 162 (74–379) | <0.0001 |
Group | ||||
---|---|---|---|---|
Control | Monitor | All Procedures | p | |
Median [IQR] | Median [IQR] | Median [IQR] | ||
Contrast medium [mL] | 104 (59–154) | 91 (62–186) | 100 (60–169) | 0.974 |
Fluoroscopy time [min] | 18.0 (13.7–23.6) | 19.4 (14.3–28.3) | 18.3 (13.9–24.4) | 0.755 |
Dose-Area product, cGy·cm2 | 24.3 (13.0–41.0) | 17.7 (11.8–36.6) | 20.6 (12.7–37.5) | 0.291 |
Dosimeter (E, first operator) [µSv] | 31.0 (16.8–52.7) | 21.4 (14.1–48.4) | 23.4 (16.0–51.1) | 0.291 |
Dosimeter (E, assistant operator) [µSv] | 4.1 (1.5–6.9) | 3.84 (0.9–11.8) | 4.1 (1.0–7.6) | 0.964 |
Dosimeter (E, nurse) [µSv] | 0.36 (0.20–0.57) | 0.20 (0.13–0.51) | 0.29 (0.15–0.56) | 0.107 |
Dosimeter (E, patient) [µSv] | 489 (310–733) | 369 (215–618) | 420 (243–656) | 0.041 |
Group | ||||
---|---|---|---|---|
Control | Monitor | All Procedures | p | |
Median [IQR] | Median [IQR] | Median [IQR] | ||
Contrast medium [mL] | 90.5 (60.0–137.0) | 89.5 (60.0–130.0) | 90.0 (60.0–132.5) | 0.877 |
Fluoroscopy time [min] | 7.6 (3.5–11.1) | 5.6 (3.8–9.1) | 6.0 (3.6–10.2) | 0.345 |
Dose-Area product, cGy·cm2 | 18.9 (11.7–33.1) | 16.4 (13.1–21.5) | 16.9 (11.0–30.0) | 0.401 |
Dosimeter (E, first operator) [µSv] | 10.6 (3.6–17.2) | 11.5 (3.7–22.0) | 11.1 (3.7–20.6) | 0.665 |
Dosimeter (E, assistant operator) [µSv] | 2.3 (0.6–3.8) | 2.0 (0.7–4.1) | 2.1 (0.6–3.9) | 0.928 |
Dosimeter (E, nurse) [µSv] | 0.25 (0.13–0.46) | 0.22 (0.15–0.44) | 0.23 (0.15–0.45) | 0.841 |
Dosimeter (E, patient) [µSv] | 315.0 (147.2–555.3) | 184.3 (110.9–386.4) | 230.2 (115.8–468.1) | 0.044 |
Group | ||||
---|---|---|---|---|
Control | Monitor | All Procedures | p | |
Median [IQR] | Median [IQR] | Median [IQR] | ||
Contrast medium [mL] | 143.0 (103.0–153.0) | 147.0 (100.3–192.8) | 143.5 (102.0–193.0) | 0.859 |
Fluoroscopy time [min] | 6.8 (3.5–11.1) | 5.6 (3.2–9.3) | 6.0 (3.3–10.6) | 0.054 |
Dose-Area product, cGy·cm2 | 33.3 (22.2–49.2) | 32.0 (20.0–45.0) | 32.4 (21.4–46.7) | 0.196 |
Dosimeter (E, first operator) [µSv] | 10.0 (3.8–21.5) | 9.5 (3.3–19.2) | 9.9 (3.5–20.1) | 0.756 |
Dosimeter (E, assistant operator) [µSv] | 1.9 (0.7–4.0) | 1.6 (0.5–4.2) | 1.7 (0.6–4.1) | 0.237 |
Dosimeter (E, nurse) [µSv] | 0.20 (0.10–0.44) | 0.18 (0.08–0.33) | 0.19 (0.10–0.36) | 0.138 |
Dosimeter (E, patient) [µSv] | 222.3 (95.6–468.7) | 126.5 (68.4–305.8) | 170.8 (76.5–398.8) | 0.001 |
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Olschewski, M.; Ullrich, H.; Brandt, M.; Steven, S.; Ahoopai, M.; Blessing, R.; Petrescu, A.; Wenzel, P.; Munzel, T.; Gori, T. Effectiveness of a Real-Time X-ray Dosimetry Monitor in Reducing Radiation Exposure in Coronary Procedures: The ESPRESSO-Raysafe Randomized Trial. J. Clin. Med. 2021, 10, 5350. https://doi.org/10.3390/jcm10225350
Olschewski M, Ullrich H, Brandt M, Steven S, Ahoopai M, Blessing R, Petrescu A, Wenzel P, Munzel T, Gori T. Effectiveness of a Real-Time X-ray Dosimetry Monitor in Reducing Radiation Exposure in Coronary Procedures: The ESPRESSO-Raysafe Randomized Trial. Journal of Clinical Medicine. 2021; 10(22):5350. https://doi.org/10.3390/jcm10225350
Chicago/Turabian StyleOlschewski, Maximilian, Helen Ullrich, Moritz Brandt, Sebastian Steven, Majid Ahoopai, Recha Blessing, Aniela Petrescu, Philip Wenzel, Thomas Munzel, and Tommaso Gori. 2021. "Effectiveness of a Real-Time X-ray Dosimetry Monitor in Reducing Radiation Exposure in Coronary Procedures: The ESPRESSO-Raysafe Randomized Trial" Journal of Clinical Medicine 10, no. 22: 5350. https://doi.org/10.3390/jcm10225350