Electromagnetically Navigated In Situ Fenestration of Aortic Stent Grafts: Pilot Animal Study of a Novel Fenestrated EVAR Approach

Penzkofer, Tobias; Na, Hong-Sik; Isfort, Peter; Wilkmann, Christoph; Osterhues, Sabine; Besting, Andreas; Hänisch, Christoph; Bisplinghoff, S.; Jansing, J.; Werder, S. von; Gooding, J.; Fuente, M. de la; Mahnken, Andreas H.; Disselhorst‐Klug, Catherine; Schmitz‐Rode, Thomas; Kuhl, Christiane K.; Bruners, Philipp

doi:10.1007/s00270-017-1769-z

Cited by 12 publications

(8 citation statements)

References 16 publications

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“…The ability to combine a sensor-equipped steerable catheter with EM navigation guidance has already been successfully tested in vivo by Penzkofer et al, 4 who reported the use of this technique to perform in situ fenestrations on porcine models. Tystad Lund et al 5 suggest a learning curve with EM-guided catheterization of renal arteries, with a significant difference in median duration time between before and after 30 attempts.…”

Section: Discussionmentioning

confidence: 99%

Branched Endovascular Thoracoabdominal Aneurysm Repair Under Electromagnetic Guidance in an in Vitro Model

Goel¹,

Rebet²,

Hengstum

et al. 2023

J Endovasc Ther

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Purpose: We report a new approach to perform endovascular treatment of thoracoabdominal aneurysms under electromagnetic navigation guidance using a modified system (IOPS; Centerline Biomedical, Inc., Cleveland, OH, USA) and a modified branched endograft (E-nside TAAA Multibranch Stent Graft System; Artivion Inc., Kennesaw, GA, USA). Case Report: We performed this case in an aortic in vitro model made from transparent polyurethane in our research hybrid room (Discovery IGS 730; GE HealthCare, Chicago, IL, USA). While the implantation of this device typically involves several challenging steps, including precise endograft implantation, snaring of preloaded guide wires, and cannulation of target visceral arteries, all were successfully performed using electromagnetic navigation guidance. Conclusion: Our preliminary experience suggests that endograft implantation under electromagnetic navigation guidance in an integrated hybrid operating room is an innovative option to address technical challenges and reduce patient and operator radiation exposure associated with complex endovascular surgery. Clinical Impact Most steps of a branched endografting procedure can be performed without X-Ray exposure when using electromagnetic navigation guidance and a modified branched endograft.

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Section: Discussionmentioning

confidence: 99%

Branched Endovascular Thoracoabdominal Aneurysm Repair Under Electromagnetic Guidance in an in Vitro Model

Goel¹,

Rebet²,

Hengstum

et al. 2023

J Endovasc Ther

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“…In a swine model, complex endovascular procedures such as in situ fenestration of endografts has been performed using EM navigation systems. 12 The endovascular specialists in this trial had no prior experience or training with the AR headset or EM tracking systems. The intuitive nature of this technology is associated with a minimal learning curve.…”

Section: Discussionmentioning

confidence: 99%

Three-Dimensional Holographic Guidance, Navigation, and Control (3D-GNC) for Endograft Positioning in Porcine Aorta: Feasibility Comparison With 2-Dimensional X-Ray Fluoroscopy

West

Al-Nimer

Goel³

et al. 2021

J Endovasc Ther

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Objectives Intraprocedural deployment of endovascular devices during complex aortic repair with 2-dimensional (2D) x-ray fluoroscopic guidance poses challenges in terms of accurate delivery system positioning and increased risk of x-ray radiation exposure with prolonged fluoroscopy times, particularly in unfavorable anatomy. The objective of this study was to assess feasibility of using an augmented reality (AR) system to position and orient a modified aortic endograft delivery system in comparison with standard fluoroscopy. Materials and Methods The 3-dimensional guidance, navigation, and control (3D-GNC) prototype system was developed for eventual integration with the Intra-Operative Positioning System (IOPS, Centerline Biomedical, Cleveland, OH) to project spatially registered 3D holographic representations of the subject-specific aorta for intraoperative guidance and coupled with an electromagnetically (EM) tracked delivery system for intravascular navigation. Numerical feedback for controlling the endograft landing zone distance and ostial alignment was holographically projected on the operative field. Visualization of the holograms was provided via a commercially available AR headset. A Zenith Spiral-Z AAA limb stent-graft was modified with a scallop, 6 degree-of-freedom EM sensor for tracking, and radiopaque markers for fluoroscopic visualization. In vivo, 10 interventionalists independently positioned and oriented the delivery system to the ostia of renal or visceral branch vessels in anesthetized swine via open femoral artery access using 3D-GNC and standard fluoroscopic guidance. Procedure time, fluoroscopy time, cumulative air kerma, and contrast material volume were recorded for each technique. Positioning and orientation accuracy was determined by measuring the target landing-zone distance error (δLZE) and the scallop-ostium angular alignment error (θSOE) using contrast-enhanced cone beam computed tomography imaging after each positioning for each technique. Mean, standard deviation, and standard error are reported for the performance variables, and Student’s t tests were used to evaluate statistically significant differences in performance mean values of 3D-GNC and fluoroscopy. Results Technical success for the use of 3D-GNC to orient and position the endovascular device at each renal-visceral branch ostium was 100%. 3D-GNC resulted in 56% decrease in procedure time in comparison with standard fluoroscopic guidance (p<0.001). The 3D-GNC system was used without fluoroscopy or contrast-dye administration. Positioning accuracy was comparable for both techniques (p=0.86), while overall orientation accuracy was improved with the 3D-GNC system by 41.5% (p=0.008). Conclusions The holographic 3D-GNC system demonstrated improved accuracy of aortic stent-graft positioning with significant reductions in fluoroscopy time, contrast-dye administration, and procedure time.

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“…A tri-dimensional fusion technique, sensorised guiding, and electromagnetically navigated devices could be helpful in this setting. 21,22 Regarding fabric strength modification, a significant mechanical strength loss was observed following both MISF and LISF. In fact, the hole creates a zone where there is a lack of fabric material, which corresponds to (i) the material degraded with the fenestration and (ii) the cutting balloon enlargement.…”

Section: Discussionmentioning

confidence: 99%

An Experimental Study of Laser in situ Fenestration of Current Aortic Endografts

Jayet

Heim

Coggia

et al. 2018

European Journal of Vascular and Endovascular Surgery

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Electromagnetically Navigated In Situ Fenestration of Aortic Stent Grafts: Pilot Animal Study of a Novel Fenestrated EVAR Approach

Cited by 12 publications

References 16 publications

Branched Endovascular Thoracoabdominal Aneurysm Repair Under Electromagnetic Guidance in an in Vitro Model

Branched Endovascular Thoracoabdominal Aneurysm Repair Under Electromagnetic Guidance in an in Vitro Model

Three-Dimensional Holographic Guidance, Navigation, and Control (3D-GNC) for Endograft Positioning in Porcine Aorta: Feasibility Comparison With 2-Dimensional X-Ray Fluoroscopy

An Experimental Study of Laser in situ Fenestration of Current Aortic Endografts

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