Name: reduction of radiation exposure during endovascular treatment of peripheral arterial disease combining fiber optic realshape technology and intravascular ultrasound
Uploaded: 2023-04-21T12:10:00
Description: Watch this Scientific Journal Video about Reduction of Radiation Exposure during Endovascular Treatment of Peripheral Arterial Disease Combining Fiber Optic RealShape Technology and Intravascular Ultr

The University Medical Center Utrecht Medical Ethics Committee approved the study protocol (METC 18/422), and the patient provided informed consent for the procedure and protocol.
1. Patient screening
<ol>
	<li>Patient inclusion
	<ol>
		<li>Ensure that the patient is &#62;18 years old.</li>
		<li>Ensure that the patient is symptomatic for PAD and/or ISR.</li>
	</ol>
	</li>
	<li>Patient exclusion
	<ol>
		<li>Exclude patients who cannot provide informed consent due to a langua...

<ol>
	<li>Song, P., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=national+prevalence+and+risk+factors+for+peripheral+artery+disease+in+2015:+an+updated+systematic+review+and+analysis.">national prevalence and risk factors for peripheral artery disease in 2015: an updated systematic review and analysis.</a> The Lancet. Global Health. 7 (8), e1020-1030 (2019).</li><li>Aday, A. W., Matsushita, K. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Epidemiology+of+peripheral+artery+disease+and+polyvascular+disease.">Epidemiology of peripheral artery disease and polyvascular disease.</a> Circulation Research. 128 (12), 1818-1832 (2021).</li><li>Meijer, W. T., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Peripheral+arterial+disease+in+the+elderly:+The+Rotterdam+Study.">Peripheral arterial disease in the elderly: The Rotterdam Study.</a> Arteriosclerosis, Thrombosis, and Vascular Biology. 18 (2), 185-192 (1998).</li><li>Modarai, B., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=European+Society+for+Vascular+Surgery+(ESVS)+2023+clinical+practice+guidelines+on+radiation+safety.">European Society for Vascular Surgery (ESVS) 2023 clinical practice guidelines on radiation safety.</a> European Journal of Vascular and Endovascular Surgery. 65 (2), 171-222 (2022).</li><li>Ko, S., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Health+effects+from+occupational+radiation+exposure+among+fluoroscopy-guided+interventional+medical+workers:+a+systematic+review.">Health effects from occupational radiation exposure among fluoroscopy-guided interventional medical workers: a systematic review.</a> Journal of Vascular and Interventional Radiology. 29 (3), 353-366 (2018).</li><li>Jansen, M., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Three+dimensional+visualisation+of+endovascular+guidewires+and+catheters+based+on+laser+light+instead+of+fluoroscopy+with+fiber+optic+realshape+technology:+preclinical+results.">Three dimensional visualisation of endovascular guidewires and catheters based on laser light instead of fluoroscopy with fiber optic realshape technology: preclinical results.</a> European Journal of Vascular and Endovascular Surgery. 60 (1), 135-143 (2020).</li><li>van Herwaarden, J. A., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=First+in+human+clinical+feasibility+study+of+endovascular+navigation+with+Fiber+Optic+RealShape+(FORS)+technology.">First in human clinical feasibility study of endovascular navigation with Fiber Optic RealShape (FORS) technology.</a> European Journal of Vascular and Endovascular Surgery. 61 (2), 317-325 (2021).</li><li>. Optical position and/or shape sensing - Google Patents. US8773650B2 Available from: <a target="_blank" href="https://patents.google.com/patent/US8773650B2/en">https://patents.google.com/patent/US8773650B2/en</a> (2014)</li><li>Pitton, M. B., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Radiation+exposure+in+vascular+angiographic+procedures.">Radiation exposure in vascular angiographic procedures.</a> Journal of Vascular and Interventional Radiology. 23 (11), 1487-1495 (2012).</li><li>Sigterman, T. A., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Radiation+exposure+during+percutaneous+transluminal+angioplasty+for+symptomatic+peripheral+arterial+disease.">Radiation exposure during percutaneous transluminal angioplasty for symptomatic peripheral arterial disease.</a> Annals of Vascular Surgery. 33, 167-172 (2016).</li><li>Segal, E., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Patient+radiation+exposure+during+percutaneous+endovascular+revascularization+of+the+lower+extremity.">Patient radiation exposure during percutaneous endovascular revascularization of the lower extremity.</a> Journal of Vascular Surgery. 58 (6), 1556-1562 (2013).</li><li>Goni, H., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Radiation+doses+to+patients+from+digital+subtraction+angiography.">Radiation doses to patients from digital subtraction angiography.</a> Radiation Protection Dosimetry. 117 (1-3), 251-255 (2005).</li><li>Klaassen, J., van Herwaarden, J. A., Teraa, M., Hazenberg, C. E. V. B. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Superficial+femoral+artery+recanalization+using+Fiber+Optic+RealShape+technology.">Superficial femoral artery recanalization using Fiber Optic RealShape technology.</a> Medicina. 58 (7), 961 (2022).</li></ol>

To our knowledge, this case report is the first to discuss the combination of FORS and IVUS to limit radiation exposure and exclude the use of a contrast agent during endovascular intervention for PAD. The combination of both techniques during the treatment of this specific lesion seems to be safe and feasible. Furthermore, the combination of FORS and IVUS makes it possible to limit radiation exposure (AK = 28.4 mGy; DAP = 7.87 Gy*cm2) and eliminates the use of contrast agents during the procedure. The present...

Peripheral arterial disease (PAD) is a progressive disease caused by arterial narrowing (stenosis and/or occlusions) and results in reduced blood flow toward the lower extremities. The global prevalence of PAD in the population aged 25 and over was 5.6% in 2015, indicating that about 236 million adults live with PAD worldwide1,2. As the prevalence of PAD increases with age, the number of patients will only increase in the coming years3. In recent decades, there has been a major shift from open to endovascular treatment for PAD. Treatment strategies can include plain old balloon angioplasty (POBA), potentially combined with other techniques like a drug-coated balloon, stenting, endovascular atherectomy, and classic open atherectomy (hybrid revascularization) to improve vascularization toward the target vessel.
During endovascular treatment of PAD, image guidance and navigation are conventionally provided by two-dimensional (2D) fluoroscopy and digital subtraction angiography (DSA). Some major drawbacks of fluoroscopically guided endovascular interventions include the 2D conversion of 3D structures and movements, and the grayscale display of endovascular navigation tools, which is not distinctive from the grayscale display of the surrounding anatomy during fluoroscopy. Furthermore, and more importantly, the increasing number of endovascular procedures still results in high cumulative radiation exposure, which may impact the health of vascular surgeons and radiologists. This is despite the current radiation guidelines, which are based on the &#34;as low as reasonably achievable&#34; (ALARA) principle that aims to achieve the lowest radiation exposure possible when performing a procedure safely4,5. Moreover, to assess the results of endovascular revascularization (e.g., after POBA), generally, one or two 2D digital subtraction angiograms are made with nephrotoxic contrast to estimate the dynamic improvement of blood flow. With this, eyeballing is needed to assess the increase in blood flow. Further, this technique also has limitations regarding assessments of vessel lumen diameter, plaque morphology, and the presence of flow-limiting dissection after endovascular revascularisation. To overcome these problems, new imaging technologies have been developed to improve device navigation and hemodynamics after treatment, and to reduce radiation exposure and the use of contrast material.
In the presented case, we describe the feasibility and efficacy of combining Fiber Optic RealShape (FORS) technology and intravascular ultrasound (IVUS) to reduce operator exposure during the endovascular treatment of PAD. FORS technology enables real-time, 3Dvisualization of the full shape of specially designed guidewires and catheters by using laser light, which is reflected along optical fibers instead of fluoroscopy6,7,8. Hereby, radiation exposure is reduced, and the spatial perception of endovascular navigation tools is improved by using distinctive colors while navigating during endovascular procedures. IVUS has the capacity to optimally define vessel dimensions. The aim of this article is to describe the method of combining FORS and IVUS stepwise, to show the potential of merging both techniques in view of the reduction of radiation exposure, and the improvement of navigation tasks and treatment success during endovascular procedures for the treatment of PAD.
Case presentation 
Here, we present a 65-year-old male with a history of hypertension, hypercholesterolemia, coronary artery disease, and infrarenal abdominal aortic and right common iliac artery aneurysms, treated with endovascular aneurysm repair (EVAR) in combination with a right sided iliac branched device (IBD). Years later, the patient developed acute lower extremity ischemia based on occlusion of the left iliac EVAR limb, requiring embolectomy of the left iliac EVAR limb and superficial femoral artery. In the same procedure, an aneurysm of the common iliac artery was eliminated by extension of the endograft into the external iliac artery.
Diagnosis, assessment, and plan 
During the follow-up, a routine duplex ultrasound showed an increased peak systolic velocity (PSV) within the left iliac limb of the stent graft of 245 cm/s, in comparison to a PSV of 70 cm/s proximally. This correlated with a significant stenosis of &#62;50% and a ratio of 3.5. A diagnosis of in-stent restenosis (ISR) of over 50% was subsequently confirmed by computed tomography angiography (CTA) imaging, with the additional suspicion that the stenosis was caused by thrombus. To prevent the recurrence of limb occlusion, a percutaneous transluminal angioplasty (PTA) was planned.

<table border="1" fo:keep-together.within-page="1" fo:keep-with-next.within-page="always">
	<tbody>
		<tr>
			<td>AltaTrack Catheter Berenstein</td>
			<td>Philips Medical Systems Nederland B.V., Best, Netherlands</td>
			<td>ATC55080BRN</td>
			<td></td>
		</tr>
		<tr>
			<td>AltaTrack Docking top</td>
			<td>Philips Medical Systems Nederland B.V., Best, Netherlands</td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>AltaTrack Guidewire</td>
			<td>Philips Medical Systems Nederland B.V., Best, Netherlands</td>
			<td>ATG35120A</td>
			<td></td>
		</tr>
		<tr>
			<td>AltaTrack Trolley</td>
			<td>Philips Medical Systems Nederland B.V., Best, Netherlands</td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Armada 8x40mm PTA balloon</td>
			<td>Abbott laboratories, Illinois, United States</td>
			<td>B2080-40</td>
			<td></td>
		</tr>
		<tr>
			<td>Azurion X-ray system</td>
			<td>Philips Medical Systems Nederland B.V, Best, Netherlands</td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Core M2 vascular system</td>
			<td>Philips Medical Systems Nederland B.V., Best, Netherlands</td>
			<td>400-0100.17</td>
			<td></td>
		</tr>
		<tr>
			<td>Hi-Torque Command guidewire</td>
			<td>Abbott laboratories, Illinois, United States</td>
			<td>2078175</td>
			<td></td>
		</tr>
		<tr>
			<td>Perclose Proglide</td>
			<td>Abbott laboratories, Illinois, United States</td>
			<td>12673-03</td>
			<td></td>
		</tr>
		<tr>
			<td>Rosen 0.035 stainless steel guidewire</td>
			<td>Cook Medical, Indiana, United States</td>
			<td>THSCF-35-180-1.5-ROSEN</td>
			<td></td>
		</tr>
		<tr>
			<td>Visions PV .014P RX catheter</td>
			<td>Philips Medical Systems Nederland B.V., Best, Netherlands</td>
			<td>014R</td>
			<td></td>
		</tr>
	</tbody>
</table>

reduction of radiation exposure during endovascular treatment of peripheral arterial disease combining fiber optic realshape technology and intravascular ultrasound

Vascular surgeons and interventional radiologists face chronic exposure to low-dose radiation during endovascular procedures, which may impact their health in the long term due to their stochastic effects. The presented case shows the feasibility and efficacy of combining Fiber Optic RealShape (FORS) technology and intravascular ultrasound (IVUS) to reduce operator exposure during the endovascular treatment of obstructive peripheral arterial disease (PAD). 
FORS technology enables real-time, three-dimensional visualization of the full shape of guidewires and catheters, embedded with optical fibers that use laser light instead of fluoroscopy. Hereby, radiation exposure is reduced, and spatial perception is improved while navigating during endovascular procedures. IVUS has the capacity to optimally define vessel dimensions. Combining FORS and IVUS in a patient with iliac in-stent restenosis, as shown in this case report, enables passage of the stenosis and pre- and post-percutaneous transluminal angioplasty (PTA) plaque assessment (diameter improvement and morphology), with a minimum dose of radiation and zero contrast agent. The aim of this article is to describe the method of combining FORS and IVUS stepwise, to show the potential of merging both techniques in view of reducing radiation exposure and improving navigation tasks and treatment success during the endovascular procedure for the treatment of PAD.

The protocol used for the presented case shows the feasibility of combining the FORS technique and IVUS, with the aim to decrease radiation exposure and contrast usage in an endovascular procedure for PAD. The majority of the procedure is performed without X-ray, and zero contrast is used. Passage through the lesion is performed by using FORS (guidewire and catheter) technology. The steps in which the X-ray is used are described in the protocol; four fluoroscopic images (needed for volume and shape registration), changin...

Watch this Scientific Journal Video about Reduction of Radiation Exposure during Endovascular Treatment of Peripheral Arterial Disease Combining Fiber Optic RealShape Technology and Intravascular Ultr

Reduction of Radiation Exposure during Endovascular Treatment of Peripheral Arterial Disease Combining Fiber Optic RealShape Technology and Intravascular Ultrasound

Described here is a stepwise method of combining Fiber Optic RealShape technology and intravascular ultrasound to show the potential of merging both techniques, in view of the reduction of radiation exposure and improvement of navigation tasks and treatment success during an endovascular procedure for the treatment of peripheral arterial disease.

Vascular surgeons and interventional radiologists face chronic exposure to low-dose radiation during endovascular procedures, which may impact their ...

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