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. Author manuscript; available in PMC: 2025 Apr 1.
Published in final edited form as: J Vasc Surg. 2023 Nov 4;79(4):954–961. doi: 10.1016/j.jvs.2023.11.002

The Effect of Fiber Optic RealShape Technology on the Reduction of Radiation During Complex Endovascular Surgery

Andrew P Sanders 1, Nicholas J Swerdlow 1,2, Gabriel Jabbour 1, Marc L Schermerhorn 1
PMCID: PMC10960673  NIHMSID: NIHMS1951885  PMID: 37931886

Abstract

Objectives:

Despite the advantages that fenestrated endovascular aortic repair (FEVAR) has over open repair it is accompanied by the consequence of radiation exposure, which can result in long-term complications for both the patient and surgical staff. Fiber Optic RealShape (FORS) technology is a novel advancement that utilizes emitted light from a fiber optic wire and enables the surgeon to cannulate vessels in real time without live fluoroscopy. This technology has been implemented at select centers to study its effectiveness for cannulation of target vessels and its impact on procedural radiation.

Methods:

We collected prospective data on PMEG cases before and after the introduction of FORS technology. FORS PMEGs were matched with up to three conventional fluoroscopy cases by number of target vessels, inclusion of a bifurcated device below, aneurysm extent, and subject BMI. The procedural radiation parameters were compared between these cohorts. Within the FORS cohort, we analyzed the rate of successful target vessel cannulation for all cases done with this technology (including cases other than PMEGs), and we compared the radiation between the cannulations using only FORS with those that abandoned FORS for conventional fluoroscopy.

Results:

Nineteen FORS PMEGs were able to be matched to 45 conventional fluoroscopy cases. Procedures that utilized FORS technology had significantly reduced total air kerma (527mGy vs 964mGy), DAP (121Gy*cm2 vs 186Gy*cm2), fluoroscopy dose (72.1Gy*cm2 vs 132.5Gy*cm2), and fluoroscopy time (45min vs 72min). There was no difference in procedure length, total contrast, or DSA. Within FORS cases, 66% of cannulations were completed using only FORS. Cannulations using only FORS had significant reduction of navigation air kerma (5.0mGy vs 26.5mGy), DAP (1.2Gy*cm2 vs 5.1Gy*cm2), and fluoroscopy time (0.6min vs 2.3min) compared to cannulations abandoning FORS for conventional fluoroscopy.

Conclusions:

This study demonstrates the advantages of FORS for total procedural radiation as well as during individual cannulation tasks. The implementation of FORS for target vessel catheterization has the potential to reduce the total degree of radiation exposure for the patient and surgical staff during complex endovascular aortic surgery.

Keywords: Fiber optics, FORS, radiation, PMEG

Table of Contents Summary:

In this retrospective study of prospectively collected institutional data, Fiber Optic RealShape (FORS) technology was associated with decreased procedural radiation during complex EVAR. This technology was feasibly implemented at a high-volume aortic center with minimal barriers to use.

Introduction

Following the introduction and FDA approval of fenestrated and branched aortic grafts, complex aortic repair became possible in many patients who would have been prohibitively high risk for open aortic surgery.1-3 These endovascular alternatives offer numerous benefits in both morbidity and mortality, but despite these advantages they are accompanied by the unique consequence of radiation exposure.4 This is especially true during complex aortic repair which is associated with higher radiation dosing and contrast usage than standard infrarenal EVAR.5-11 Many practices have been implemented to reduce the degree of radiation during these cases, but fluoroscopy has remained an integral and unavoidable part of endovascular aortic surgery.12,13

The detrimental long-term effects of radiation exposure are well known and, unfortunately, apply to both the patient and surgical staff.5,14-17 Despite the use of lead coverings and other protective gear, exposure to harmful radiation still occurs routinely.18,19 Fiber Optic RealShape (FORS) technology is a novel advancement that seeks to mitigate this exposure by drastically reducing the degree of radiation required during endovascular surgery. The technology is predicated upon using emitted light from a fiber optic wire to generate a reconstructed image of the wire position overlayed on a radiographic image. This is a dynamic technology that allows instantaneous three-dimensional visualization of the wire position, which enables the surgeon to cannulate vessels in real time without the use of live fluoroscopy.

In 2021 FORS was introduced at select international centers to investigate its effectiveness for cannulation of target vessels and its impact on procedural radiation. The previously published data on this topic have shown promising initial results with regards to vessel catheterization and radiation reduction.20,21 In this study we add to the limited prior data and report our initial institutional experience with this technology and the way that it has impacted our complex aortic repair practice.

Methods

Data Source

This study was comprised of prospectively collected institutional data from January 2018 through March 2023. These data include patients who underwent a Physician Modified Endograft (PMEG) using standard fluoroscopy, as well as patients who underwent a PMEG using FORS technology. Additionally, the dataset includes iliac branch device (IBD), embolization, and infrarenal EVAR cases that were performed with FORS technology. These non-PMEG cases were used only for the individual task success analysis that was conducted within the FORS cohort.

We chose 2018 as the starting point for data inclusion. This was done to obtain an adequate sample of standard fluoroscopy patients and also to provide a fair temporal comparison to the FORS cohort, which was introduced at our institution in late-2021. Additionally, by excluding cases prior to 2018 we are excluding our early PMEG experience (which began in 2012), and therefore the cases included in this study are thought to be most consistent with our contemporary practice. PMEG cases that utilize standard fluoroscopy are present in the database before and after the introduction of FORS technology.

This study was approved by the Beth Israel Deaconess Medical Center IRB under protocol number 2021-P-000219. All patients who underwent a FORS procedure have signed informed consent for inclusion in this study and for use of this technology. The standard fluoroscopy cohort includes PMEG cases from before and after an Investigational Device Exemption (IDE) trial was begun at our institution in May 2021 (NCT# 04746677). The pre-IDE trial patients were submitted to the FDA in support of the IDE trial.

Patient Cohorts and Matching

Cohorts were defined by whether the case was performed entirely with standard fluoroscopy, or whether the case used FORS at any point. For instance, if a case utilizing FORS was unable to complete an aspect of the procedure with FORS technology (and reverted to standard fluoroscopy), that case was still included within the FORS cohort.

To obtain the cohorts of PMEG patients to be used in the study, we utilized a standard matching scheme that matched to the type of aneurysm (TAAA vs AAA), the number of fenestrations of the PMEG (three or less vs four or greater), the inclusion of a bifurcated device below the PMEG (yes vs no), and the patient BMI (which required the matches to be within +/−1 unit of each other). This method was preferred over propensity score matching due to the desire to match on only four specific procedural parameters. FORS cases were matched with up to three conventional fluoroscopy cases without replacement, as able.

The analysis of individual cannulation tasks was performed for all cases that utilized FORS technology. Here, the cohorts were defined by whether the task was completed entirely with FORS, or if the task abandoned FORS in favor of standard fluoroscopy. Accordingly, it is possible for a single patient to have their individual cannulation tasks distributed between both cohorts.

Definitions and Variables

For all patients, we assessed age, sex, race, BMI, and smoking status. Additionally, we collected data on the aneurysm diameter, the type of aneurysm, number of vessels involved, and whether the case included placement of a bifurcated device below the PMEG, as previously described for our matching scheme.

For the comparison between conventional fluoroscopy and FORS, our primary outcomes were the overall procedural parameters. These included total procedure time (min), total contrast volume (mL), total air kerma (mGy), total dose area product (DAP, Gy*cm2), total digital subtraction angiography (DSA, Gy*cm2), total fluoroscopy dose (Gy*cm2), and total fluoroscopy time (min). These variables were collected at the end of each case by trained research personnel.

With regards to the task analysis within the FORS cases, we collected similar data for the navigational component of each individual cannulation task. The navigation targets included the visceral vessels, internal iliac vessels, external iliac vessels, and the contralateral gate. The navigational data that we collected included air kerma (mGy), DAP (Gy*cm2), fluoroscopy time (min), and total cannulation time (min). Additionally, we analyzed the success rate of catheterizations that used only FORS and conducted a subanalysis of the visceral vessel (celiac artery, superior mesenteric artery, right renal artery, and left renal artery) and iliac vessel (bilateral internal iliac, bilateral external iliac, and contralateral gate) success rates. Data collection was started once the FORS wire was visible on screen and ended when the FORS wire (or conventional wire for those cases that abandoned FORS) was replaced with a stiff guidewire to begin the treatment component. These data were collected at the time of the case by trained research personnel.

FORS Equipment and Technique

There are three permanent devices which are necessary in the endovascular suite for the use of this technology. The first is a computer with the FORS software, the second is the FORS engine which contains much of the hardware where the image reconstruction is processed, and third is the bedside docking station which connects to the FORS enabled wires and catheters. At present, there are three such wires and catheters available; a 120cm 0.035 inch diameter non-backloadable AltaTrack guidewire, an 80cm 5.5 Fr Berenstein catheter, and an 80cm 5.5 Fr C2 catheter. These are used exclusively during the navigational phase of the procedure because the wire is non-backloadable and therefore cannot be used for the treatment portion (such as stent deployment).

During the case, the dynamic three-dimensional position of the FORS wire is fused with static radiographic imaging which is used as a roadmap. The prevailing FORS catheterization technique at our institution is to use a deflecting tip sheath with the FORS catheter advanced to the tip of the sheath allowing visualization. Once the PMEG is inserted, we use the FORS wire and catheters with a combination of saved fluoroscopy images to cannulate the fenestrations and then use saved fluoroscopy runs and image fusion to observe the interaction of the wire and catheter with the visceral arterial anatomy. Preoperative CTA fusion, DSA, and hand injection under fluoroscopy can all be used to facilitate FORS cannulations (Figure 1). Additionally, we can rotate the 3-D roadmap into positions that aren’t available with the c-arm alone. Once the vessel has been cannulated, the FORS wire is exchanged for a stiff guidewire to begin the treatment portion. If unable to complete the cannulation solely with the FORS devices, conventional catheters and wires are used in lieu of, or in addition to, the FORS devices.

Figure I. Representative Images of FORS Usage.

Figure I.

A. Navigation through left renal fenestration of PMEG into distal portion of artery using FORS wire and catheter in conjunction with live fluoroscopy and image overlay B. Navigation through SMA fenestration of PMEG with FORS wire and catheter in conjunction with live fluoroscopy with hand injection of contrast and 3d CT reconstruction C. Navigation into hypogastric branch for embolization using fluoroscopy with image fusion and hand injection of contrast D. Navigation into distal hypogastric using FORS wire and catheter with live fluoroscopy with hand injection of contrast and 3d CT reconstruction

Prior to the implementation of FORS, we have routinely used CT image fusion for all endovascular aortic cases. We continue to use CT image fusion for endovascular aortic cases when we are not using FORS.

Statistical Analysis

Continuous variables were compared using the t-test (when normality was assumed) or Wilcoxon rank-sum test (when normality was not assumed) and are presented as mean (standard deviation [SD]) or median (interquartile range [IQR]), respectively. Binary and categorical variables were compared using Pearson’s χ2 test and are presented as percentages. A p-value of <.05 was considered statistically significant. The cohorts were generated through a standard matching program which matched exactly on the binary variables (TAAA vs AAA, whether there were 4+ fenestrations, and whether there was a bifurcated device below), and within one unit for patient BMI. From these parameters, we matched up to three conventional fluoroscopy cases to each FORS PMEG without replacement. All statistical analysis was performed using Stata version 17.0 (StataCorp, College Station, TX, USA).

Results

Patient Cohort and Characteristics

We were able to successfully identify at least one match for 19 of the 24 PMEGs that had been performed using FORS. For 11 of the 19 cases we identified three matches, for four of the cases we identified two matches, and for the final four cases we identified one match. This resulted in a total of 45 matched conventional fluoroscopy cases.

With regards to baseline characteristics, there was no significant difference between the FORS and non-FORS cohorts for age (77.8 years vs 74.6 years), proportion male (84% vs 80%), race (84% white vs 89% white), BMI (27.8 vs 27.1), and aneurysm diameter (69.2 mm vs 63.7 mm) (Table 1). The cohorts did differ in terms of smoking status, where the FORS cases were less likely to be current smokers (21% vs 49%, p=.008).

Table 1.

Baseline Characteristics for Matched Patients

Non-FORS FORS p-value
N 45 19
Age, mean (SD) 74.6 (6.5) 77.8 (8.4) 0.11
Sex 36 80% 16 84% 0.69
Race White 40 89% 16 84% 0.60
Black 1 2% 0 0%
Other/Unknown 4 9% 3 16%
Smoking Never 6 13% 0 0% 0.01
Former 17 38% 15 79%
Current 22 49% 4 21%
BMI, mean (SD) 27.1 (4.7) 27.8 (6.0) 0.59
Aneurysm Diameter, mean (SD) 63.7 (10.8) 69.2 (33.7) 0.35
Fenestrations, mean (SD) 4.0 (0.4) 4.0 (0.3) 0.65
TAAA 6 13% 4 21% 0.44
Included Bifurcated Graft 44 98% 18 95% 0.52

Overall Procedural Characteristics

Comparing FORS cases to non-FORS cases, we found no significant difference in the total procedure time (192 minutes vs 177 minutes, p=.17), total contrast volume (140 mL vs 108 mL, p=.11), and total DSA (42.5 Gy*cm2 vs 51.1 Gy*cm2, p=.26) (Table 2). FORS was significantly favorable with regards to total air kerma (527 mGy vs 965 mGy, p=.002), total DAP (121 Gy*cm2 vs 186 Gy*cm2, p=.006), total fluoroscopy dose (72.1 Gy*cm2 vs 132.5 Gy*cm2, p=.003), and total fluoroscopy time (45.1 mins vs 72.0 mins, p<.001) (Table 2).

Table 2.

Overall Procedural Outcomes of Matched Cohorts

Non-FORS FORS p-value
N 45 19
Procedure Time (min) 177.0 (145.0, 232.0) 192.0 (160.0, 271.0) 0.17
Total Contrast (mL) 108.0 (50.0, 188.0) 140.0 (110.0, 165.0) 0.11
Total Air Kerma (mGy) 964.0 (651.0, 1469.0) 527.0 (327.0, 893.0) 0.002
Total DAP (Gy*cm2) 186.1 (126.9, 310.5) 121.0 (84.0, 165.0) 0.006
Total DSA (Gy*cm2) 51.1 (34.8, 82.9) 42.5 (30.0, 64.4) 0.26
Total Fluoro Dose (Gy*cm2) 132.5 (82.4, 226.5) 72.1 (45.7, 97.9) 0.003
Total Fluoro Time (min) 72.0 (56.0, 90.0) 45.1 (34.7, 49.0) <0.001

Individual Task Outcomes

Looking within all FORS cases, we identified 157 total individual vessel cannulations. Of these 157 cannulations, 103 were performed using only FORS, a 66% success rate. The remaining 54 tasks were started with FORS, but then reverted to standard fluoroscopy. We found that for every metric studied, the tasks completed using only FORS were superior to those that used standard fluoroscopy. This included total navigation time (5 mins vs 9 mins, p<.001), navigation fluoroscopy time (0.6 mins vs 2.3 mins, p<.001), navigation air kerma (5.0 mGy vs 26.5 mGy, p<.001), and navigation DAP (1.2 Gy*cm2 vs 5.1 Gy*cm2, p<.001) (Table 3).

Table 3.

Individual Task Outcomes Stratified by Successful FORS Usage

Unsuccessful Successful p-value
N 54 103
Total Navigation Time (min) 9 (5.0, 14.0) 5 (3.0, 8.0) <0.001
Navigation Fluoro Time (min) 2.3 (1.3, 4.7) 0.6 (0.2, 1.4) <0.001
Navigation Fluoro Time, Normalized* (%) 28.5 (20.0, 41.3) 12.5 (6.7, 20.0) <0.001
Navigation Air Kerma (mGy) 26.5 (12.0, 51.0) 5 (2.4, 12.0) <0.001
Navigation DAP (Gy*cm2) 5.1 (2.3, 10.9) 1.2 (0.6, 2.4) <0.001
*

Normalized represents the navigation fluoro time as a percentage of the total navigation time

Upon sub-analysis of the visceral vessel cannulations, we found success rates of 42%, 47%, 57%, and 56% for the celiac, superior mesenteric, right renal, and left renal arteries, respectively. There was no significant difference in likelihood of success between the visceral vessels (p=.75) (Table 4). Analysis of the iliac system revealed success rates of 92%, 88%, 100%, 73%, and 56% for the contralateral gate, right common iliac, left common iliac, right internal iliac, and left internal iliac arteries, respectively. While it approached significance, the likelihood of success between the iliac vessels did not reach the 0.05 threshold (p=.057) (Table 4). Lastly, we compared the two systems as a whole and found a success rate of 51% for visceral vessel cannulations and a success rate of 83% for iliac system cannulations. Here, we found that the iliac system cannulations were significantly more likely to be successful (p<.001) (Table 4).

Table 4.

Univariable Analysis of Successful FORS Usage Within Target Vessels

No.
Successful
Percent
Successful
p-value
Visceral Artery Celiac 8 42% 0.75
SMA 9 47%
RRA 13 57%
LRA 15 56%
Iliac Artery Cont. Gate 23 92% 0.057
RCIA 7 88%
LCIA 9 100%
RIIA 11 73%
LIIA 5 56%
Vessel System Visceral 45 51% <.001
Iliac 55 83%

Discussion

Since the implementation of FORS technology at our institution, we have noted many positive impacts to radiation dosing during complex endovascular surgery. With regards to the overall procedural parameters, we found that cases using FORS had significantly less radiation while having minimal difference in length of the operation or volume of contrast used. When looking at the success of individual vessel cannulations, we found that the target could be cannulated using only FORS in approximately 66% of the attempts. Additionally, we found that when cannulations were completed with only FORS, they used approximately five times less radiation than those cannulations that reverted to standard fluoroscopy.

The results that we have identified are not surprising. The fact that a low radiation alternative to standard fluoroscopy is associated with less radiation is not exactly a shocking statement. Instead, what we find most impactful from our experience is that the implementation of this technology was feasible and that it resulted in minimal differences in operative time and contrast usage. When new technology becomes available, there is often a tradeoff between the benefits that it offers and the difficulties associated with its adoption. With FORS the benefits are clear in terms of decreased radiation dosing for both the patient and surgical team. The difficulties with its implementation can be thought of as falling into one of two categories: the cost of new equipment, and the technical issues that accompany that new equipment.

With regards to cost, the initial investment in a new technology is an unavoidable but necessary expense for the advancement of practice. With FORS, this investment comes in the form of the compatible wires and catheters, and the cost of the FORS engine and docking station (the main hardware components necessary for use of the technology). A prior study by Kang et al identified that the endovascular graft itself was the largest driver of the increased cost associated with endovascular repairs.22 While FORS wires and catheters may have an increased cost relative to those used with standard fluoroscopy, the largest component of the procedural cost is unchanged between these two techniques. The permanent equipment (i.e. the FORS engine and the docking station) represents an up-front investment, but with each subsequent case performed the cost per use of the equipment decreases, similar to other permanent fixtures in OR suites (like in room CT, hi-resolution displays, etc.). Further, and at the crux of the value of this technology, there are likely to be future cost benefits of lower radiation in the form of less radiation induced disease, which may become evident in the years to come.

Beyond the initial increased costs, new technology is often accompanied by technical difficulties that require adjustment and adaptation. With FORS, these technical difficulties were most often related to the current wires and catheters that are compatible with the system. The FORS AltaTrack guidewire is both stiffer and shorter than the navigational wires that are preferred at our institution. Additionally, this wire is tethered to the docking station which has implications for maneuverability and tactile feel during cannulation attempts. Similarly, the available catheters (Berenstein and C2) are also stiffer and have different functionality than our more commonly used catheters. Lastly, the current system is limited in use by the need to be joined to the docking station. As such, vessel cannulation is possible with FORS, but vessel treatment (such as stent deployment) necessitates reversion to conventional wires and fluoroscopy use.

Despite these difficulties, we still prefer the FORS system over standard fluoroscopy. We expect many of these issues to improve or resolve with the subsequent development and release of additional FORS compatible devices. This will offer a more diverse range of wires and catheters as well as the possibility of backloadable devices, which will enable an even larger portion of the procedure to be accomplished without fluoroscopy. Corollary to this point, we found that visceral vessel cannulations were completed with FORS only 51% of the time. Often, this failure was due to tortuous or calcified vessels as well as the previously described stiffness and functionality of the FORS equipment. While the successful proportion is expected to increase with improved comfort with presently available equipment, the attending surgeon is also more likely to allow the trainee to struggle with cannulation when minimal radiation is being delivered and there is less concern of causing a dissection with the FORS wire. These points suggest that the true benefit of FORS may be attenuated despite the already significant differences that have been identified, and we plan to compare our early and more recent experiences in a subsequent study. With additional FORS wires and catheters that are more like the preferred conventional counterparts, and with increased experience and comfort with the technology, we believe the success rate of FORS cannulations could increase. This in turn may lead to an even further reduction in procedural radiation.

Despite the benefits that we have identified while using this novel technology, our study is not without limitations. First, our FORS cohort is relatively small, with only 19 cases. While we have performed more than 19 FORS cases, we felt it was imperative to restrict the cohort to complex aneurysm cases to conduct a fair comparison of our primary outcomes. For instance, we have performed infrarenal AAA repairs using FORS, but felt it would be inappropriate to include a case such as that along with complex visceral aneurysms that necessitated four-vessel PMEGs. The radiation dosage during an endovascular case has been shown to increase with the degree of complexity or number of fenestrations, therefore including these less complicated cases would have added confusion to the interpretation of our primary outcomes.8,9 Despite restricting the cohort to PMEGs, we obtained significant results even with this relatively small cohort. Additionally, as this is an ongoing study, our cohort numbers (both FORS and conventional cases) will continue to increase and become more robust once current FORS equipment supply chain issues resolve.

Another limitation was the inability to identify three matched conventional fluoroscopy cases for each FORS case. This was due to the stringent matching scheme that we employed; specifically, how matched cases required a BMI within one unit of each other. Multiple prior studies have examined the relationship between BMI and radiation dosing and have shown that elevated BMI is associated with longer case times, increased fluoroscopy, and increased DAP, which holds true in vascular surgery as well as other specialties that utilize fluoroscopy.11,23-25 Being that our primary outcomes were focused on radiation dosing, we felt it was imperative to match our cohorts with as similar BMI as possible, as has been done in prior studies on radiation.25 While widening the BMI range may have produced a more complete 1:3 match, we felt that this would offer a less fair comparison and would have diminished the importance of any potential results. Additionally, this is another limitation that we expect to improve as more cases are enrolled into each cohort.

One final limitation is that we did not have an ideal marker of complexity by which to compare the FORS and standard fluoroscopy cases. As part of the matching scheme we included the number of fenestrations, whether the aneurysm was thoracoabdominal or isolated to the abdomen, and whether the case involved placement of a bifurcated device below the graft. These factors allowed us to match similar cases but may not have perfectly matched the more nuanced complexity of each case. For example, it would be possible to include more minute information on angulation of the target vessels, their degree of stenosis, their degree of calcification, and whether there is a prior stent in the vessel, but we do not believe that matching on these additional characteristics would have proved beneficial. If information with that level of granularity were used in the matching scheme, it would have further reduced the size of the cohorts and the ability to generate three matches for each case. As it is, we feel that the complexity of the FORS and non-FORS cases are matched to a fair, albeit not perfect, degree. While it is certainly possible that a non-FORS case may have been more technically challenging than a FORS case, we believe that overall, the opposite is true. Given the shortage of FORS equipment (due to the previously referenced supply chain issues with wires and catheters) we have selectively used FORS for the cases that were deemed to be more complex based upon preoperative imaging. As such, the FORS cases are assumed to represent a generally more complicated repair. Ultimately, once enough centers have familiarity with the technology, a randomized trial would be the best method to compare the radiation delivered between FORS and non-FORS cases.

The introduction of FORS technology at our institution has already had a dramatically beneficial impact on radiation dosing during complex aortic surgery. Further, the analysis of individual tasks provides specific information about the utility of FORS which will allow us to later analyze the learning curve and how successful use of the technology has changed over time. Additionally, we found that the implementation of this technology was feasible and there were minimal barriers to its usage. Going forward, we expect that the current barriers to usage will diminish once supply chain issues are resolved and additional devices become available. Technology such as this has the potential to improve long term patient outcomes and to reduce the risk associated with endovascular radiation for the patient and surgical team. As a field, vascular surgery has pioneered many new technologies and it is possible that radiation-free navigation such as this is the next breakthrough in a long line of vascular imaging innovations.

Conclusions

Fiber Optic RealShape technology decreases the radiation exposure during complex aortic surgery and during individual vessel cannulation, which has obvious benefits for both patient and practitioner. Moreover, this technology can feasibly be implemented at a high-volume aortic center with relatively few hindrances. Despite the issues that often accompany the introduction of new technology, novel methods of advanced image guidance, such as FORS, have a viable future and the potential to advance the field of vascular surgery.

Article Highlights:

Type of Research:

Retrospective cohort study using prospectively collected institutional data on a novel technology.

Key Findings:

Compared to cases using only conventional fluoroscopy, Physician Modified Endograft (PMEG) cases which used Fiber Optic RealShape (FORS) technology had decreased procedural radiation dosing without a difference in the length of procedure or volume of contrast used. Additionally, target vessel cannulations which used only FORS used less radiation than those cannulations that reverted to conventional fluoroscopy.

Take Home Message:

Implementation of FORS technology is feasible at high volume aortic centers and can reduce the radiation associated with complex endovascular aortic surgery without sacrificing the speed at which it is done.

Funding:

AS is supported by the Harvard-Longwood Research Training in Vascular Surgery NIH T32 Grant #5T32HL007734-29

This work was conducted with support from Harvard Catalyst ∣ The Harvard Clinical and Translational Science Center (National Center for Advancing Translational Sciences, National Institutes of Health Award UL1 TR002541) and financial contributions from Harvard University and its affiliated academic healthcare centers. The content is solely the responsibility of the authors and does not necessarily represent the official views of Harvard Catalyst, Harvard University and its affiliated academic healthcare centers, or the National Institutes of Health.

Footnotes

Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

Conflicts of Interest:

None

Presentation Information:

This study was presented as a rapid-fire presentation at the 2023 New England Society for Vascular Surgery Annual Meeting, Boston, MA, Oct 06 - 08, 2023.

References

  • 1.Kimball AS, Mydlowska A, Beck AW. Physician-modified endografts for urgent and emergent aortic pathology. Semin Vasc Surg. 2021. Dec;34(4):215–24. [DOI] [PubMed] [Google Scholar]
  • 2.O’Donnell TFX, Patel VI, Deery SE, Li C, Swerdlow NJ, Liang P, et al. The state of complex endovascular abdominal aortic aneurysm repairs in the Vascular Quality Initiative. J Vasc Surg. 2019. Aug;70(2):369–80. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 3.Starnes BW. Physician-modified endovascular grafts for the treatment of elective, symptomatic, or ruptured juxtarenal aortic aneurysms. J Vasc Surg. 2012. Sep;56(3):601–7. [DOI] [PubMed] [Google Scholar]
  • 4.Atkins AD, Atkins MD. Branched and Fenestrated Aortic Endovascular Grafts. Methodist DeBakey Cardiovasc J. 2023;19(2):15–23. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 5.Attigah N, Oikonomou K, Hinz U, Knoch T, Demirel S, Verhoeven E, et al. Radiation exposure to eye lens and operator hands during endovascular procedures in hybrid operating rooms. J Vasc Surg. 2016. Jan;63(1):198–203. [DOI] [PubMed] [Google Scholar]
  • 6.Sailer AM, Schurink GWH, Bol ME, de Haan MW, van Zwam WH, Wildberger JE, et al. Occupational Radiation Exposure During Endovascular Aortic Repair. Cardiovasc Intervent Radiol. 2015. Aug;38(4):827–32. [DOI] [PubMed] [Google Scholar]
  • 7.Kirkwood ML, Chamseddin K, Arbique GM, Guild JB, Timaran D, Anderson JA, et al. Patient and operating room staff radiation dose during fenestrated/branched endovascular aneurysm repair using premanufactured devices. J Vasc Surg. 2018. Nov;68(5):1281–6. [DOI] [PubMed] [Google Scholar]
  • 8.Monastiriotis S, Comito M, Labropoulos N. Radiation exposure in endovascular repair of abdominal and thoracic aortic aneurysms. J Vasc Surg. 2015. Sep;62(3):753–61. [DOI] [PubMed] [Google Scholar]
  • 9.Budtz-Lilly J, Liungman K, Wanhainen A, Mani K. Correlations Between Branch Vessel Catheterization and Procedural Complexity in Fenestrated and Branched Endovascular Aneurysm Repair. Vasc Endovascular Surg. 2019. May;53(4):277–83. [DOI] [PubMed] [Google Scholar]
  • 10.Wilson-Stewart KS, Fontanarosa D, Malacova E, Trapp JV. A comparison of patient dose and occupational eye dose to the operator and nursing staff during transcatheter cardiac and endovascular procedures. Sci Rep. 2023. Feb 10;13(1):2391. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 11.Ketteler ER, Brown KR. Radiation exposure in endovascular procedures. J Vasc Surg. 2011. Jan;53(1 Suppl):35S–38S. [DOI] [PubMed] [Google Scholar]
  • 12.Stangenberg L, Shuja F, van der Bom IMJ, van Alfen MHG, Hamdan AD, Wyers MC, et al. Modern Fixed Imaging Systems Reduce Radiation Exposure to Patients and Providers. Vasc Endovascular Surg. 2018. Jan;52(1):52–8. [DOI] [PubMed] [Google Scholar]
  • 13.Kirkwood ML, Arbique GM, Guild JB, Timaran C, Chung J, Anderson JA, et al. Surgeon education decreases radiation dose in complex endovascular procedures and improves patient safety. J Vasc Surg. 2013. Sep;58(3):715–21. [DOI] [PubMed] [Google Scholar]
  • 14.El-Sayed T, Patel AS, Cho JS, Kelly JA, Ludwinski FE, Saha P, et al. Radiation-Induced DNA Damage in Operators Performing Endovascular Aortic Repair. Circulation. 2017. Dec 19;136(25):2406–16. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 15.Dainiak N. Radiation Dose and Stochastic Risk From Exposure to Medical Imaging. Chest. 2013. Nov;144(5):1431–3. [DOI] [PubMed] [Google Scholar]
  • 16.Bacon JD, Slade E, Smith AL, Allareddy G, Duan R, Fraser JF, et al. Potentially Harmful Ionizing Radiation Exposure from Diagnostic Tests and Medical Procedures in Patients with Aneurysmal Subarachnoid Hemorrhage. World Neurosurg. 2020. Aug;140:e153–60. [DOI] [PubMed] [Google Scholar]
  • 17.Brambilla M, Cerini P, Lizio D, Vigna L, Carriero A, Fossaceca R. Cumulative radiation dose and radiation risk from medical imaging in patients subjected to endovascular aortic aneurysm repair. Radiol Med (Torino). 2015. Jun;120(6):563–70. [DOI] [PubMed] [Google Scholar]
  • 18.Tzanis E, Tsetis D, Kehagias E, Ioannou CV, Damilakis J. Occupational exposure during endovascular aneurysm repair (EVAR) and aortoiliac percutaneous transluminal angioplasty (PTA) procedures. Radiol Med (Torino). 2019. Jun;124(6):539–45. [DOI] [PubMed] [Google Scholar]
  • 19.Maurel B, Hertault A, Sobocinski J, Le Roux M, Gonzalez TM, Azzaoui R, et al. Techniques to reduce radiation and contrast volume during EVAR. J Cardiovasc Surg (Torino). 2014. Apr;55(2 Suppl 1):123–31. [PubMed] [Google Scholar]
  • 20.Panuccio G, Schanzer A, Rohlffs F, Heidemann F, Wessels B, Schurink GW, et al. Endovascular navigation with Fiber Optic RealShape technology. J Vasc Surg. 2023. Jan;77(1):3–8.e2. [DOI] [PubMed] [Google Scholar]
  • 21.Finnesgard EJ, Simons JP, Jones DW, Judelson DR, Aiello FA, Boitano LT, et al. Initial single-center experience using Fiber Optic RealShape guidance in complex endovascular aortic repair. J Vasc Surg. 2023. Apr;77(4):975–81. [DOI] [PubMed] [Google Scholar]
  • 22.Kang J, Barnes JA, Suckow BD, Goodney PP, Columbo JA, Zwolak RM, et al. The financial evolution of endovascular aneurysm repair delivery in contemporary practice. J Vasc Surg. 2021. Mar;73(3):1062–6. [DOI] [PubMed] [Google Scholar]
  • 23.Cushman D, Mattie R, Curtis B, Flis A, McCormick ZL. The effect of body mass index on fluoroscopic time and radiation dose during lumbar transforaminal epidural steroid injections. Spine J Off J North Am Spine Soc. 2016. Jul;16(7):876–83. [DOI] [PubMed] [Google Scholar]
  • 24.Gurkan S, Gur O, Sahin A, Donbaloglu M. The impact of obesity on perioperative and postoperative outcomes after elective endovascular abdominal aortic aneurysm repair. Vascular. 2023. Apr;31(2):211–8. [DOI] [PubMed] [Google Scholar]
  • 25.Stangenberg L, Shuja F, Carelsen B, Elenbaas T, Wyers MC, Schermerhorn ML. A novel tool for three-dimensional roadmapping reduces radiation exposure and contrast agent dose in complex endovascular interventions. J Vasc Surg. 2015. Aug;62(2):448–55. [DOI] [PubMed] [Google Scholar]

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