New tools to reduce radiation exposure during aortic endovascular procedures

Figures & data

Figure 1. Flowchart of the search strategy for this systematic review.

Table 1. Overview of articles included in the review.

Author, Year	Study type, design	N	Intervention/ model	Conclusion	Limitations
Electromagnetic tracking:
Cochennec [19], 2013	Phantom study	9 operators	Transparent anthromorphic aortic arch phantom	EM navigation might be beneficial as complementary image modality in terms of radiation exposure and cannulation performance	Small sample size, lack off aortic pulsatility movements and spatial variability in this in vitro set-up.
Condino [20], 2014	Phantom study	15 operators	Abdominal aortic aneurysm model	Proof of concept for simultaneous use of EM navigation of guidewires and catheters is feasible without fluoroscopy use	Used navigating system can’t compensate for breathing and cardiac cycle movements.
Manstad-Hulaas [21], 2012	Clinical study, Prospective	17 patients	EVAR	3D EM navigation is a feasible technology for guidance during EVAR procedures	Only used tracked catheters because guidewires were too fragile to use.
Tystad-Lund [22], 2017	Phantom study	5 operators	Elastic phantom of abdominal aorta and iliac arteries	3D EM navigation is not inferior to fluoroscopy in its ability to guide endovascular interventions	Simple phantom was used without complex tortuous anatomy. EM relies on static image volumes and can’t compensate for dynamic in vivo factors. Commercially available equipment rarely features EM tracking support. Therefore setup is complicated as often custom-made devices must be used.
Image Fusion:
Ahmad [13], 2019	Clinical study, Retrospective	146 patients	TEVAR	Use of IF results in lower contrast usage and tends toward a reduction in procedure time during complex TEVAR	Retrospective design with somewhat inhomogeneous cohort. Moreover, high-rate of poor quality of used preoperative CTA and outcomes might be affected by learning curve of surgeons.
Ahmad [23], 2018	Clinical study, Retrospective	152 patients	EVAR	IF registration using two bi-planar fluoroscopy images is sufficiently accurate and reduces radiation exposure and procedure time when surgeons are more experienced	Retrospective design and outcomes can be influenced by learning curve of operators
De Beaufort [29], 2021	Clinical study, Randomized controlled pilot	37 patients	Aortoilliac occlusive disease	Use of IF results in reduction of radiation related measured parameters with similar procedure time and higher contrast agent doses	Small number of cases with a wide range of complexity and not stratified on TASC lesion scores. In addition, outcomes can be influenced by learning curve as surgeons did not perform same number of cases.
Dias [24], 2015	Clinical study, Retrospective	226 patients	EVAR, FEVAR, BrEVAR, TEVAR	Protocol that combines use of reduced fluoroscopy frame rate, low concentration iodine contrast medium and IF seems to provide more complete approach toward reduction of radiation exposure and contrast volume	Retrospective design and matching of control group was limited due to progressive introduction of different measures
Dijkstra [25], 2011	Clinical study, Retrospective	89 patients	FEVAR	Use of IF with CBCT is a valuable addition in endovascular procedures as its use results in lower contrast agent doses and ultimately reduce operative and fluoroscopy times	Retrospective design
Hertault [30], 2014	Clinical study, Prospective	497 patients	EVAR, FEVAR, BrEVAR, TEVAR	Compared to previous studies significant reduction in radiation exposure for both patient and operators	Comparison between Mobile C-arm without IF and Hybrid OR with IF. Moreover surgeon experience is not taken into account
Hiraoka [26], 2018	Clinical study, Retrospective	263 patients	EVAR, TEVAR	Use of intraoperative 3D IF decreases radiation exposure and contrast use	Retrospective study in a single center with relatively small sample number. In addition, no adjustment for surgeon experience and possible learning curve
McNally [14], 2015	Clinical study, Retrospective	72 patients	FEVAR	Use of intraoperative 3D IF during FEVAR decreases radiation exposure, procedure time and contrast agent usage	Procedures are performed by a single surgeon in a single center which probably introduces bias. Moreover, study can’t account for influence of procedure difficulty radiation exposure
Rolls [31], 2016	Clinical study, Prospective	42 patients	FEVAR	IF may contribute to overall improved awareness of radiation safety practices that lead to significant overall reduction in radiation	Comparison between modern practice and historic group. Lack of consistency in frame rate in control group could contribute to large radiation doses
Sailer [32], 2014	Clinical study, Prospective	62 patients	FEVAR, BrEVAR	IF guidance provided added value for FEVAR/BrEVAR procedures in terms of procedure time and contrast volume reduction	Procedure complexity influences procedure time, contrast volume and radiation dose and controls were retrieved from primarily historical procedures. Moreover, possible introduction of bias in operator experience
Stangenberg [27], 2015	Clinical study, Retrospective	32 patients	EVAR	IF allowed significant reduction in radiation dose, fluoroscopy time contrast agent and procedure length	Retrospective design with matched case-control groups.
Tacher [28], 2013	Clinical study, Retrospective	37 patients	FEVAR, BrEVAR, ChEVAR	IF reduces injected contrast volume and maintains radiation exposure and procedure time	Retrospective analysis on a small number of patients. Chronological enrollment of patients could be considered as bias based on operators learning curve. In addition, in the conventional 2D fluoroscopy group were less FEVAR procedures included.
Intravascular Ultrasound:
Pecoraro [33], 2019	Clinical study, Retrospective	52 patients	EVAR	Use of IVUS during EVAR is feasible and determined significant reduction in contrast volume and radiation exposure	Retrospective study with a small sample size. In addition there are slight differences between propensity matched groups.
Intravascular Ultrasound in combination with electromagnetic tracking:
Shi [34], 2016	Phantom study	-	Rigid transparent descending aortic model	Practical solution for real-time intravascular reconstruction based on sensor fusion between IVUS and position information of EM-tracking	Only tested in single phantom set-up. No participants performing procedure.
Robotic navigation system:
Riga [35], 2011	Phantom study	17 operators	Type 1 and type 3 Aortic arch phantom	Robotic technology has the potential to reduce time, risk of embolization, radiation exposure and manual skill required for carotid arch vessel cannulation	Phantom does not reflect all challenges of navigation within clinical setting.
Robotic navigation system in combination with electromagnetic tracking:
Schwein [36], 2018	Phantom study	6 operators	Rigid aortic aneurysmal phantom	Value of combination of 3D control and 3D navigation is confirmed and shows promising results in further reduction of procedure time and improved catheter motion	In vitro nature of study
Schwein [16], 2017	Phantom study	18 operators	Rigid aortic aneurysmal phantom	Use of flexible robotic catheters combined with EM tracking of catheter tip allows better real-time 3D orientation and significantly reduces fluoroscopy and cannulation time	EM-sensor in the catheter lumen prevented the use of a guidewire and therefore comparison with 2D fluoroscopy is difficult. Moreover study is limited by small number of participants and in vitro nature.
Fiber Optic Shape Sensing:
Jäckle [37], 2019	Phantom study	-	3D Printed aortic model	Test within endovascular scenario shows promising results for use of multicore fibers for shape sensing in catheters	Tests were performed under ideal circumstances. No navigational or cannulation tasks were performed
Van Herwaarden [17], 2021	Clinical study, Prospective	22 patients	EVAR, FEVAR, BrEVAR, IBD, Peripheral	Real-time 3D navigation using FORS technology is safe and feasible in endovascular procedures	Learning curve during clinical practice. Moreover there are only two available catheters and limited working length

Abbreviations: EM, electromagnetic; IF, image fusion; IVUS, intravascular ultrasound; FORS, FiberOptic Real shape; CTA, computed tomography angiography; CBCT, cone-beam computed tomography; OR, operating room; 2D, two-dimensional; 3D, three-dimensional; EVAR, endovascular aortic aneurysm repair; TEVAR, thoracic endovascular aortic aneurysm repair; FEVAR, fenestrated endovascular aortic aneurysm repair; BrEVAR, branched endovascular aortic aneurysm repair; ChEVAR, chimney endovascular aortic aneurysm repair; TASC, Trans-Atlantic Inter-Society Consensus Document

Table 2. Overview of clinical studies in which a (potential) radiation reducing tool is compared with a conventional control group.

Author, year	N	Type of intervention	Procedure time, minutes	Cumulative radiation dose, AK (mGy) or DAP (Gycm^2)	Fluoroscopy time, minutes	Contrast volume, mL
Electromagnetic tracking:
Manstad-Hulaas [21], 2012	17	EVAR (EM 7 & Control 10)	EM; 141 ± 24; Control 118 ± 24; P = 0.108	DAP: EM 273.76 ± 92.39; Control 169.59 ± 60.57; P = 0.043	-	EM 232 ± 66; Control 243 ± 69; P = 0.950
Image Fusion:
Ahmad [13], 2019	146	TEVAR (IF 98 & Control 48)	-	-	-	IF 70 (IQR 50–101); Control 104 (IQR 69–168); P < 0.001
		TEVAR without carotid subclavian bypass (IF 44 & control 30)	IF 74 (IQR 54–116); Control 85 (IQR 64–111); P = 0.545	DAP: IF 19.92 (IQR 10.89–39.48); Control 30.97 (IQR 16.11–48.83); P = 0.281	IF 9; Control 9; P < 0.848	IF 83 (IQR 54–120); Control 120 (IQR 75–160); P = 0.058
		TEVAR with carotid subclavian bypass (IF 26 & control 11)	IF 162 (IQR 139–199); Control 213 (IQR 189–298) P = 0.015	DAP: IF 36.657 (IQR 12.371–51.831); Control 24.83 (IQR 11.885–35.201); P = 0.370	IF 9 (IQR 6–13); Control 23 (IQR 12–45); P < 0.005	IF 64 (IQR 43–81); Control 98 (IQR 60–180); P = 0.003
Ahmad [23], 2018	152	EVAR (IF 105 & Control 47)	-	DAP: IF 23.437 (15.77–51.44); Control 32.19 (14.31–49.42); P = 0.457	-	IF 58 (IQR 38–88); Control 98 (IQR 66–113); P < 0.001
De Beaufort [29], 2021	37	Aortoiliac occlusive disease (IF 18 & Control 19)	IF 60 (IQR 42–90); Control 60 (IQR 30–90)	AK: IF 100 (IQR 40–300); Control 120 (IQR 60–200) DAP: IF 18.5 (IQR 6.9–45.5); Control 21.8 (IQR 9.9–36.8)	IF 5.1 (IQR 3.7–15.4); Control 5.7 (IQR 1.8–10.8)	IF 41 (IQR 30–60); Control 30 (IQR 22–55)
Dias [24], 2015	226	All EVAR (IF 103 & Control 123)	IF 230 (IQR 134–331); Control 235 (IQR 158–364); P = 0.942	DAP: IF 199.34 (IQR 113.34–306.15); Control 328.56 (IQR 195.62–556.78); P < 0.0001	IF 66 (IQR 33–102); Control 72 (IQR 42–102); P = 0.837	IF 103 (IQR 63–145); Control 215 (IQR 166–280); P < 0.0001
		Thoracoabdominal aneurysm repair (IF 33 & Control 23)	IF 349 (IQR 261–438); Control 459 (IQR 391–607); P = 0.007	DAP: IF 262.87 (IQR 202.98–367.67); Control 638.91 (IQR 436.96–1002.66); P < 0.0001	IF 103 (IQR 84–139); Control 127 (IQR 104–157); P = 0.103	IF 143 (IQR 196–197); Control 298 (IQR 234–363); P < 0.0001
		Juxtarenal aneurysm repair (IF 21 & Control 36)	IF 231 (IQR 163–332); Control 277 (IQR 193–374); P = 0.319	DAP: IF 241.72 (IQR 140.44–432.04); Control 283.24 (IQR 192.08–499.57); P = 0.581	IF 72 (IQR 48–131); Control 87 (IQR 58–99); P = 0.581	IF 96 (IQR 69–144); Control 208 (IQR 162–238); P < 0.0001
		Aortoiliac aneurysm repair with IBD (IF 17 & Control 24)	IF 191 (IQR 130–258); Control 249 (IQR 191–281); P = 0.131	DAP: IF 188.76 (IQR 121.94–234.93); Control 468.67 (IQR 328.87–617.08); P < 0.0001	IF 57 (IQR 35–76); Control 80 (IQR 60–101); P = 0.077	IF 132 (IQR 85–185); Control 255 (IQR 224–312); P < 0.0001
		Infrarenal aneurysm repair (IF 22 & Control 25)	IF 128 (IQR 102–151); Control 149 (IQR 119–193); P = 0.459	DAP: IF 98.85 (IQR 83.63–164.70); Control 213.83 (IQR 123.99–290.14); P = 0.013	IF 25 (IQR 18–40); Control 38 (IQR 30–45.3); P = 0.185	IF 84 (IQR 49–136); Control 160 (IQR 146–204); P < 0.0001
		Thoracic aneurysm repair (IF 10 & Control 15)	IF 83 (IQR 56–183); Control 144 (IQR 95–144); P = 0.459	DAP: IF 90.40 (IQR 61.95–158.49); Control 172.98 (IQR 143.76–386.32); P = 0.41	IF 14 (IQR 9–31); Control 28 (IQR 19–39); P = 0.688	IF 53 (IQR 40–175); Control 178 (IQR 128–282); P = 0.400
Dijkstra [25], 2011	89	FEVAR (IF 40 & Control 49)	IF 330 (IQR 273–522); Control 387 (IQR 290–477); P = 0.651	AK: IF 7 (IQR 4–12); Control 7 (IQR 5–10); P = 0.782	IF 81 (IQR 54–118); Control 90 (IQR 46–128); P = 0.932	IF 94 (IQR 72–131); Control 136 (IQR 96–199); P = 0.001
Hertault [30], 2014	397	EVAR (IF 44 & Control 199)	IF 92.5 (IQR 75–120); Control 93 (IQR 75.120); P = 0.97	DAP: IF 12.2 (IQR 8.7–19.9); Control 30.0 (IQR 20.0–43.5); P < 0.01	-	IF 59 (IQR 50–75); Control 80 (IQR 65–106); P = 0.34
		FEVAR (IF 18 & Control 54)	IF 150 (IQR 150–160); Control 150 (IQR 105–180); P = 0.39	DAP: IF 43.7 (IQR 24.7–57.5); Control 72.9 (IQR 52–109.2); P < 0.01	-	IF 105 (IQR 70–136); Control 138 (IQR 100–160); P = 0.03
		BrEVAR (IF 20 & Control 20)	IF 205 (IQR 169–240); Control 210 (IQR 150–260); P = 0.87	DAP: IF 47.4 (IQR 37.2–108.2); Control 159.0 (IQR 101.8–222.4); P < 0.01	-	IF 120 (IQR 100–170); Control 226 (IQR 150–278); P < 0.01
		TEVAR (IF14 & Control 28)	IF 80 (IQR 60–105); Control 117 (IQR 60–138); P = 0.22	DAP: IF 24.7 (IQR 22.0–28.7); Control 20.0 (IQR 11.4–30.0); P = 0.63	-	IF 80 (IQR 50–100); Control 100 (IQR 78–140); P = 0.07
Hiraoka [26], 2018	263	EVAR (IF 81& Control 62)	IF 116 ± 27; Control 113 ± 37; P = 0.487	AK: IF 768 ± 529; Control 880 ± 833; P = 0.333	-	IF 76.2 ± 27.6; Control 89 ± 28.5; P = 0.009
		TEVAR (IF 83 & Control 37)	IF 86.2 ± 23.9; Control 96.4 ± 27.0; P = 0.023	AK: IF 638 ± 463; Control 872 ± 623; P = 0.033	-	IF 72.6 ± 21.1; Control 85.6 ± 31.1; P = 0.009
McNally [14], 2015	72	All FEVAR (IF 31 & Control 41)	-	AK: IF 2200 ± 1300; Control 5000 ± 280; P < 0.0001	IF 55 ± 21; Control 84 ± 36; P = 0.0004	IF 34 ± 15; Control 86 ± 25; P < 0.0001
		2 FEVAR (IF 12 & Control 8)	-	AK: IF 1380 ± 520; Control 3400 ± 1900; P = 0.001	IF 41 ± 11; Control 63 ± 29; P = 0.02	IF 26 ± 8; Control 69 ± 16; P < 0.0001
		3 or 4 FEVAR (IF 19 & Control 33)	IF 230 ± 50; Control 330 ± 100; P = 0.002	AK: IF 2700 ± 1400; Control 5400 ± 2225; P < 0.0001	IF 64 ± 21; Control 89 ± 36; P = 0.02	IF 39 ± 17; Control 90 ± 25; P < 0.0001
Rolls [31], 2016	42	FEVAR (IF 19 (2 lost due to learning curve) & Control 21)	IF 282 (IQR 268–322); Control 450 (IQR 360–450); P < 0.001	AK: IF 1590 (IQR 1090–2110); Control 4400 (IQR 3200–7000); P < 0.001 DAP: IF 158 (IQR 123–226); Control 264 (IQR 173.3–366.8); P = 0.006	-	-
Sailer [32], 2014	62	FEVAR and BrEVAR (IF 23 & Control 23)	IF 312 ± 108; Control 378 ± 144; P = 0.022	-	IF 50.43 ± 29.58; Control 59.48 ± 28.02; P = 0.38	IF 159 ± 27; Control 199 ± 29; P = 0.037
Stangenberg [27], 2015	32	EVAR (IF 16 & Control 16)	IF 80.4 ± 21.1; Control 110 ± 29.1; P = 0.005	AK: IF 1067 ± 470.4; Control 1768 ± 696.2; P = 0.004	IF 18.4 ± 6.8; Control 26.8 ± 10.0; P = 0.01	IF37.4 ± 21.3; Control 77.3 ± 23.0; P < 0.001
Tacher [28], 2013	37	FEVAR, BrEVAR and ChEVAR (IF 14 & 3D 14 & 2D 9)	IF 189 ± 60; 3D 181 ± 53; 2D 233 ± 123; P = 0.59 (IF vs 3D vs 2D)	DAP: IF 656 ± 457; 3D 984 ± 581; 2D 1188 ± 1067; P = 0.18 (2D vs 3D vs IF)	IF 80 ± 36; 3D 42 ± 22; 2D 82 ± 46; P = 0.04 (2D vs 3D vs IF) & P = 0.18 (3D vs 2D) & P = 0.02 (3D vs IF)	IF 65 ± 28; 3D 225 ± 119; 2D 235 ± 145; P = 0.0002 (IF vs 2D) & P = <0.0001 (IF vs 3D)
Intravascular Ultrasound:
Pecoraro [33], 2019	52	EVAR (IVUS 26 & Control 26)	IVUS 179 (IQR 120–210); Control 176 (IQR 124–210); P = 0.48	DAP: IVUS 15 (IQR 9–21); Control 32 (IQR 16–44); P = 0.002	IVUS 12 (IQR 9–16); Control 20 (IQR 12–25); P = 0.001	IVUS 50 (IQR 20–68); Control 92 (IQR 50–125); P = 0.003

Abbreviations: EVAR, endovascular aortic aneurysm repair; TEVAR, thoracic endovascular aortic aneurysm repair; FEVAR, fenestrated endovascular aortic aneurysm repair; BrEVAR, branched endovascular aortic aneurysm repair; ChEVAR, chimney endovascular aortic aneurysm repair; IBD, iliac branched device; EM, electromagnetic; IF, image fusion; IVUS, intravascular ultrasound; AK, air kerma; DAP, dose area product; IQR, interquartile range; 2D, two-dimensional; 3D, three-dimensional.

Table 3. Overview of studies reporting cannulation task characteristics.

Author, Year	Study type	Model/Intervention	Task	Cannulation attempts	Vessel wall hits	Cannulation time, minutes	Fluoroscopy time, minutes
Electromagnetic tracking:
Cochennec [19], 2013	In vitro	Transparant anthropomorphic aortic arch phantom	LSA, LCCA, RCCA	-	EM 8.5 (IQR 16–38); Control 14 (IQR 11–16)	EM 1.27 (IQR 1.13–1.68); Control 1.45 (IQR 1.07–2.13)	EM 26.5 (IQR 19.7–30.7); Control 87 (IQR 64–128)
Condino [20], 2014	In vitro	Abdominal Aortic aneurysm model	LRA, RRA	EM 4.0 (IQR 2.00–5.00); Control 4.0 (IQR 2.00–5.00); P = 0.72	EM 3.50 (IQR 2.50–7.00); Control 5.50 (IQR 2.00–10.00); P = 0.65	-	EM 0; Control 2.10 (IQR 1.30–3.90)
Manstad-Hulaas [21], 2012	Prospective	EVAR	CL gate	EM 4.2 ± 2.8; Control 14.4 ± 12.4; P = 0.059	-	EM 7.0 ± 2.8; Control 5.3 ± 4.0; P = 0.282	-
Robotic navigation system:
Riga [35], 2011	In vitro	Type 1 Aortic Arch	LCCA	RNS 9 (IQR 7–25); Control 61 (IQR 51–165); P = 0.001	RNS 0 (IQR 0–1); Control 2 (IQR 1.5–13); P = 0.001	RNS 0.80 (IQR 0.30–1.57); Control 2.70 (IQR 1.92–3.98); P = 0.001	-
			RCCA	RNS 9 (IQR 6–10); Control 48 (IQR 21–81); P = 0.001	RNS 2 (IQR 1.5–3.5); Control 4.5 (IQR 3.5–11.3); P = 0.001	RNS 0.69 (IQR 0.44–0.99); Control 1.70 (IQR 1.20–3.35)	-
Riga [35], 2011 (continued)			LSA	RNS 7 (IQR 6–10); Control 18 (IQR 14–31); P = 0.001	-	RNS 0.25 (IQR 0.18–0.31); Control 0.76 (IQR 0.34–0.88); P = 0.002	-
			RSA	RNS 11 (IQR 81–15); Control 22 (IQR 15–48); P = 0.005	-	-	-
		Type 3 Aortic Arch	LCCA	RNS 14 (IQR 12–21); Control 89 (IQR 45–284); P = 0.001	RNS 0.5 (IQR 0.3–1.5); Control 13.8 (IQR 9.5–19); P = 0.001	RNS 1.02 (IQR 0.61–2.10); Control 3.78 (IQR 0.92–11.28); P = 0.01	-
			RCCA	RNS 30 (IQR 9–38); Control 209 (IQR 124–335); P = 0.001	CCA Origin Hits: RNS 5 (IQR 4–9); Control 9 (IQR 5–21.5); P = 0.04	RNS 1.81 (IQR 0.67–3.02); Control 6.2 (IQR 3.02–8.97); P = 0.001	-
			LSA	RNS 7 (IQR 6–11); Control 24 (IQR 17–38); P = 0.001	-	-	-
			RSA	RNS 31 (IQR 16–42); Control 69 (IQR 48–81); P = 0.003	-	-	-
Robotic navigation system in combination with electromagnetic tracking:
Schwein [36], 2018	In vitro	rigid aortic aneurysmal phantom	LRA	-	-	EM+RNS 2.07; Control 2.68	EM+RNS 0.08; Control 2.22
			CL gate	-	-	EM+RNS 2.15; Control 4.37	EM+RNS 0.03; Control 3.41
Schwein [16], 2017	In vitro	rigid aortic aneurysmal phantom	LRA	-	-	EM+RNS 0.08; Control 2.22	EM+RNS 2.07; Control 2.68
			CL gate	-	-	EM+RNS 0.03; Control 3.41	EM+RNS 2.15; Control 4.37
Fiber Optic Shape Sensing:
Van Herwaarden [17], 2021	Prospective	TEVAR, BrEVAR, FEVAR, peripheral	Combined	-	-	FOSS 13.3 ± 18.1	FOSS 3.15 ± 8.26
			CT	-	-	FOSS 15.3 ± 1.5	FOSS 2.99 ± 2.32
			SMA	-	-	FOSS 13.0 ± 6.2	FOSS 4.89 ± 4.49
			LRA	-	-	FOSS 33.6 ± 44.7	FOSS 10.29 ± 16.94
			RRA	-	-	FOSS 32.8 ± 33.1	FOSS 13.48 ± 21.93
			IIA	-	-	FOSS 24.5 ± 24.8	FOSS 5.10 ± 2.55

Abbreviations: EM, electromagnetic; RNS, robotic navigation system; FOSS, fiber optic shape sensing; LSA, left subclavian artery; RSA, right subclavian artery; LCCA, left common carotid artery; RCCA, right common carotid artery; CT, celiac trunk; SMA, superior mesenteric artery; LRA, left renal artery; RRA, right renal artery; IIA, internal iliac artery; EVAR, endovascular aortic aneurysm repair; TEVAR, thoracic endovascular aortic aneurysm repair; FEVAR, fenestrated endovascular aortic aneurysm repair; BrEVAR, branched endovascular aortic aneurysm repair.

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