Aug 2026· Journal of Endovascular Therapy· pp.
15266028261479886
· 0 citations· 15 references
Medicine
TL;DR
Fiber Optic RealShape has an acceptable technical success rate in visceral TV catheterization during cEVAR, which has improved following the 3D-Hub implementation, supporting initial FORS use in all catheterizations to minimize radiation.
Abstract
Purpose
Fiber Optic RealShape (FORS) is a novel technology using light instead of X-rays to visualize guidewire and catheters during endovascular procedures. A 3D-Hub allows visualization of conventional catheters when used in combination with the FORS guidewire. This study evaluates the FORS performance and radiation exposure during visceral target vessel (TV) catheterization in complex endovascular aortic repair (cEVAR).
Materials And Methods
Single-centre data were retrieved from the prospective FORS Learn Registry cohort study. The primary outcome was FORS technical success, defined as successful catheterization using FORS without reverting to a conventional guidewire. Secondary outcomes included catheterization and fluoroscopy time, Dose Area Product (DAP) and Air Kerma (AK), compared across technical success, technical failure and conventional catheterizations using analysis of variance (ANOVA) with post hoc testing.
Results
Between December 2020 and December 2023, 96 patients underwent cEVAR. In total 319 visceral targets were catheterized, including 176 FORS attempts with a technical success rate of 63.6%. This success rate decreased in TVs with versus without ostial stenosis (21.7% vs 69.9%, P < .001) or with versus without calcification (14.3% vs 67.9%, P < .001), and increased with versus without the use of the 3D-Hub (80.6% vs 60.0%, P = .039). Type of TV, stent graft configuration or prior TV stent did not affect technical success rates. Radiation exposure was significantly lower during successful FORS catheterizations (fluoroscopy time 1.7 ± 2.1 min; DAP 3.7 ± 8.5 Gy∙cm2; AK 30.8 ± 55.9 mGy) compared to FORS technical failures (fluoroscopy time 6.5 ± 4.3 min, P < .001; DAP 8.8 ± 6.4 Gy∙cm2, P = .030; AK 126.5 ± 116.5 mGy, P < .001) and conventional catheterizations (fluoroscopy time 6.2 ± 9.2 min, P < .001; DAP 9.4 ± 20.25 Gy∙cm2, P = .003; AK 111.5 ± 151.1 mGy, P < .001). No significant differences occurred between technically failed and conventional catheterizations. Catheterization time was shortest with FORS technical success (6.5 ± 5.0 min) compared to conventional catheterizations (9.7 ± 13.5 min, P = .015), followed by technical failure (14.3 ± 6.9 min, P < .001).
Conclusion
Fiber Optic RealShape has an acceptable technical success rate in visceral TV catheterization during cEVAR, which has improved following the 3D-Hub implementation. Successful FORS catheterization results in reduced radiation exposure and catheterization time. When reversion to conventional catheterization is required, outcomes remain comparable to primary conventional procedures, supporting initial FORS use in all catheterizations to minimize radiation. Continued device and software development is essential to optimize FORS performance.Clinical ImpactFiber Optic RealShape (FORS) is a new technology that enables visualization of exclusive FORS-guidewires and catheters using light pulses instead of radiation. This study shows acceptable technical success rates with reduced radiation exposure compared to technically unsuccessful FORS and primary conventional catheterizations of visceral target vessels during complex endovascular aortic repair. These findings support the clinical benefit of initially attempting catheterization with FORS, as it results in reduced radiation exposure, even in case of reversion to conventional devices, without compromising patient outcomes. Additionally, the technical success rates improved significantly following the implementation of the 3D Hub.
Remotely deflectable guidewires are a recently introduced clinical tool in neurointervention. Although their efficacy and safety during early clinical use have been reported, detailed descriptions of technical nuances and advanced applications are limited.
We performed a retrospective review of endovascular procedures at our center in which the Drivewire 24 (DW24) guidewire (Rapid Medical, Yokneam, Israel) was used, from its introduction in our department in May 2024 through January 2026. Cases were screened to identify novel technical applications of the DW24.
The DW24 was used in 48 neurointerventional procedures, including mechanical thrombectomy (n=20), aneurysm treatment (n=12; 2 ruptured and 10 unruptured), dural arteriovenous fistula embolization (n=7), venous interventions (n=4), middle meningeal artery embolization (n=2), superselective cerebral angiography (n=2), and endoleak embolization (n=1). Several novel technical applications of the DW24 were identified and described in detail, accompanied by annotated procedural images.
Several unique technical applications of the DW24, enabled by the combination of its distinctive diameter and in situ deflectability, represent a meaningful advancement in neurointerventional practice. Several limitations of the DW24, compared with traditional microwires, may reflect the relatively early phase of this technology.
Uri Singfer, Ronette Goodluck Tyndall, J. Sousa et al.· JNIS Advances· 0 citations
OBJECTIVE
To assess technical feasibility and procedural features of the Amplatz Left (AL) guiding catheter-assisted partial deployment (ATTAIN) technique for selected right-sided low-origin vertebral artery ostial stenosis (VAOS).
METHODS
We prospectively studied 10 consecutive patients. Technical success required accurate balloon-expandable drug-eluting stent placement and expansion without access crossover, guide-catheter exchange, or salvage techniques. Safety outcomes included 30-day neurological and access-site events and follow-up stent-related events. Preprocedural assessment considered vertical ostial depth (VOD) and subclavian-vertebral geometry.
RESULTS
During the 17-month enrollment period, technical success was achieved in 9 of 10 patients (90%). Median age was 71.5 years (IQR, 69-74); median VOD was 12.5 mm (IQR, 11-16). Among successful procedures, median deployment time was 28 minutes (IQR, 22-32). Median stenosis decreased from 76.5% (IQR, 73%-83%) to 2.5% (IQR, 0%-9%). At 3 months, symptoms completely resolved in 6 patients, partially improved in 2, and remained unchanged in 2; all had modified Rankin Scale scores of 0 or 1. No clinically apparent stroke, transient ischemic attack, or death occurred within 30 days; one unconfirmed minor access-site event was recorded. At a median 8-month follow-up (IQR, 5-11; range, 3-15), 9 patients underwent imaging, no stent fracture or in-stent restenosis was identified.
CONCLUSIONS
In this proof-of-concept series, the ATTAIN technique showed preliminary feasibility and provided a standardized AL guiding-catheter-assisted deployment sequence for selected right-sided low-origin VAOS. Comparative efficacy, definitive safety, and left-sided applicability remain unestablished.
Han-Ming Ge, Xiao-Bo Zhang, Zhanhua Liang et al.· World Neurosurgery· 0 citations
Background: Endovascular aneurysm repair (EVAR) is used to treat patients with abdominal aortic aneurysm (AAA) who have suitable anatomy, while complex AAAs often require fenestrated and branched stent grafts, necessitating further refinement of the technique. Objective: To evaluate the safety and efficacy of fenestrated/branched EVAR (F/B-EVAR) assisted by three-dimensional (3D) printing for treating complex AAA. Design: Retrospective cohort study. Methods: This multicenter retrospective cohort study collected baseline data and clinical outcomes from patients treated with F/B-EVAR between January 2012 and June 2025. The population was divided into the 3D simulation group and the conventional measurement group. The 3D simulation group underwent a simulation to assess fenestration and branch positioning strategies. Study endpoints included procedural success rate, incidence of periprocedural complications and major adverse events, as well as procedural duration and radiation dose. Results: The mean age of patients was 70.2 ± 8.8 years, with 68.9% being male. Compared to the conventional measurement group, the 3D simulation group had a significantly higher procedural success rate (98.8% vs 91.6%, p < 0.001), shorter procedural duration ((115.2 ± 35.0) min vs (138.7 ± 43.7) min, p < 0.001), and lower radiation dose ((107.2 ± 43.9) mGy vs (144.5 ± 56.3) mGy, p < 0.001). Furthermore, although no significant differences were observed in the incidence of all-cause mortality and major cardiovascular adverse events during the 30-day follow-up between the two groups, the incidence of life-threatening major bleeding, major vascular complications, and acute kidney injury stage ⩾3 was significantly lower in the 3D simulation group. Conclusion: F/B-EVAR guided by 3D simulation may allow for accurate planning of fenestration and branch positioning, potentially improving procedural success rate and suggesting a potential to enhance the quality of outcomes.
Yujing Zhang, Jing Wang, Cheng-Long Qu et al.· Therapeutic Advances in Card...· 0 citations
Endovascular aortic repair (EVAR) has emerged as a popular option for minimally invasive treatment of abdominal and thoracic aortic aneurysms, offering advantages over traditional open surgical methods by reducing immediate postoperative morbidity and mortality. Although the endovascular repair option is attractive, it can potentially increase patient risks associated with x-ray exposure during the procedure, as significant levels of ionizing radiation are generated during preoperative diagnostic angiography, perioperative device placement, and lifelong follow-up imaging. For treatment of complex aortic aneurysms involving visceral vessels, radiation exposure during fenestrated stent-graft repair is typically double that of conventional unfenestrated stent-graft delivery and placement, which puts patients and clinicians at risk of reaching lifetime radiation limits and potentially developing cancer. To address this issue, a novel electromagnetic (EMAG) system has been developed and studied to potentially reduce radiation overexposure during the procedures by expediting a key step of the process, namely cannulation of fenestrations. The solenoid electromagnetic EMAG system embedded surrounding the ostia of the fenestrations attracts the magnetized tip of either a guidewire or catheter into a side branch, rapidly and selectively cannulating branch vessels in the aorta. The EMAG prototype was designed and fabricated with selective design requirements. A comparative study between the EMAG system and a standard guidewire demonstrated that the average time to cannulate with the EMAG system was 5.73 ± 2.67 seconds, which was significantly less than the average time taken to cannulate with the standard guidewire (34.37 ± 39.91 seconds, P < .01). In addition, the feasibility of the EMAG device was evaluated by characterizing its attraction force, dislodging force, and temperature rise. This device has the potential to reduce radiation exposure during EVAR procedures, offering a promising approach to improve patient safety in an increasingly common procedure.Clinical ImpactThe findings of this study demonstrate the feasibility of the EMAG system as a novel approach for assisting branch-vessel cannulation during fenestrated endovascular aortic repair. By advancing this technology through further preclinical and clinical studies, the EMAG system has the potential to improve workflow, enhance procedural consistency, reduce fluoroscopy dependence, and contribute to safer and more efficient complex endovascular interventions.
Bryan W. Tillman, Gordon K Bryson, Catherine C. Go et al.· Journal of Endovascular Ther...· 0 citations
The transradial approach using dedicated guiding catheters, such as the RIST guiding catheter, has gained popularity in neuroendovascular treatment. However, concerns remain regarding system instability. We evaluated the feasibility and safety of transradial approach with advancement of the RIST to a higher and more stable position (petrous to cavernous segment of the internal carotid artery). We conducted a single-center, retrospective, era-based cohort study comparing a transfemoral approach-first era (2022-2023) with a transradial approach with high RIST placement-first era (2024-2025). Consecutive adult patients who underwent endovascular treatment for unruptured intracranial aneurysms were included. After the exclusion of posterior circulation and ruptured aneurysms, 171 procedures (96 transfemoral approach and 75 transradial approach) were analyzed. The primary outcome was procedural success. Safety outcomes included neurological complications, access-site complications, and 30-day mortality. The primary analysis was era-based; sensitivity analyses were performed per protocol, and subgroup analyses focused on lesion laterality. In the transradial approach-first era, the procedural success rate was 99% (odds ratio 1.57, 95% confidence interval 0.14-17.70, p > 0.99), neurological complications occurred in 3%, access-site complications in 3%, and 30-day mortality in 0%, comparable to those in the transfemoral approach-first era. Sensitivity analyses restricted to cases with high RIST placement yielded similar results. The subgroup analysis did not reveal any interaction between outcomes and lesion laterality; The P-values for interaction were 0.294 for procedural success, 0.079 for periprocedural neurological complications, and 0.176 for access-site complications. Transradial approach using a high RIST placement appears feasible and safe, achieving high success and low complication rates.
S. Miyamoto, W. Tsuruta, Shuhei Egashira et al.· Neurologia medico-chirurgica· 0 citations
BACKGROUND
A novel fiberoptic transcatheter aortic valve replacement (TAVR) guidewire was developed that enables continuous hemodynamic monitoring, easy pacing over the wire, and guiding of the valve prosthesis.
OBJECTIVES
This study aimed to evaluate construct validity of hemodynamic measurements obtained with the fiberoptic TAVR guidewire compared to conventional fluid-filled pigtail catheters.
METHODS
This prospective registry study included patients undergoing TAVR. Complete hemodynamic assessment was performed in-duplo with the fiberoptic TAVR guidewire and conventional pigtail catheters. Primary endpoint was the agreement between modalities for post-TAVR mean pressure gradient (PG). Secondary endpoints included agreement in assessing paravalvular regurgitation and in-depth signal analysis using a validated automated algorithm.
RESULTS
This study included 150 patients (mean age 79.7 ± 5.8 years; 46.7% female). Comparison of invasive pressure measurements yielded moderate to excellent agreement (intraclass correlation coefficient [ICC]-range: 0.65 to 0.95). Bias was observed in left ventricular end-diastolic pressure (LVEDP), with the fiberoptic guidewire measuring higher LVEDPs (+3.5 mm Hg). Post-TAVR mean PG showed a mean absolute difference of 2.7 ± 2.1 mm Hg (ICC: 0.67), minimal bias (-0.45 mm Hg), and 87% concordance with a discrete cutoff (10 mm Hg). Good overall agreement was observed for most indices of paravalvular regurgitation (ICC-range: 0.81-0.87). Automated algorithm assessment revealed fewer artefacts and calibration errors for the fiberoptic guidewire (P = 0.048), repeat analysis improved mean PG agreement (ICC-range: 0.80-0.85).
CONCLUSIONS
The fiberoptic guidewire effectively classified clinically relevant transvalvular gradients with limited bias post-TAVR, although it produced higher LVEDPs, possibly reflecting wire-induced leaflet interaction. Algorithm-derived assessment revealed the fiberoptic guidewire producing measurements with fewer artefacts and calibration errors, supporting its proof-of-concept potential to complement current invasive assessment standards.
Geert A A Versteeg, Maarten A. B. Westerhof, N. Stens et al.· JACC: Advances· 0 citations