TY - JOUR
T1 - First in Human Clinical Feasibility Study of Endovascular Navigation with Fiber Optic RealShape (FORS) Technology
AU - van Herwaarden, Joost A.
AU - Jansen, Marloes M.
AU - Vonken, Evert jan P.A.
AU - Bloemert-Tuin, Trijntje
AU - Bullens, Roland W.M.
AU - de Borst, Gert J.
AU - Hazenberg, Constantijn E.V.B.
N1 - Funding Information:
This work was supported by Philips Medical Systems Netherlands B.V.
Funding Information:
Philips Medical Systems Netherlands B.V. provided a research grant according to fair market value to the Division of Surgical Specialties of the University Medical Center Utrecht to support this study. The Division of Surgical Specialties of the University Medical Center Utrecht has a research and consultancy agreement with Philips. The department of Vascular Surgery is part of the Division of Surgical Specialties. J. van Herwaarden and C. Hazenberg are or have been consultants for Cook Medical, Gore Medical, Medtronic and Terumo Aortic. G. de Borst has been consultant for Gore Medical. R. Bullens is an employee of Philips Medical Systems. The views expressed in this article are those of the authors and do not necessarily reflect those of Philips Medical Systems.
Funding Information:
Philips Medical Systems Netherlands B.V. provided a research grant according to fair market value to the Division of Surgical Specialties of the University Medical Center Utrecht to support this study. The Division of Surgical Specialties of the University Medical Center Utrecht has a research and consultancy agreement with Philips. The department of Vascular Surgery is part of the Division of Surgical Specialties. J. van Herwaarden and C. Hazenberg are or have been consultants for Cook Medical, Gore Medical, Medtronic and Terumo Aortic. G. de Borst has been consultant for Gore Medical. R. Bullens is an employee of Philips Medical Systems. The views expressed in this article are those of the authors and do not necessarily reflect those of Philips Medical Systems.This work was supported by Philips Medical Systems Netherlands B.V.
Publisher Copyright:
© 2020 The Authors
PY - 2021/2
Y1 - 2021/2
N2 - Objective: Endovascular procedures are conventionally conducted using two dimensional fluoroscopy. A new technology platform, Fiber Optic RealShape (FORS), has recently been introduced allowing real time, three dimensional visualisation of endovascular devices using fiberoptic technology. It functions as an add on to conventional fluoroscopy and may facilitate endovascular procedures. This first in human study assessed the feasibility of FORS in clinical practice. Methods: A prospective cohort feasibility study was performed between July and December 2018. Patients undergoing (regular or complex) endovascular aortic repair (EVAR) or endovascular peripheral lesion repair (EVPLR) were recruited. FORS guidance was used exclusively during navigational tasks such as target vessel catheterisation or crossing of stenotic lesions. Three types of FORS enabled devices were available: a flexible guidewire, a Cobra-2 catheter, and a Berenstein catheter. Devices were chosen at the physician's discretion and could comprise any combination of FORS and non-FORS devices. The primary study endpoint was technical success of the navigational tasks using FORS enabled devices. Secondary study endpoints were user experience and fluoroscopy time. Results: The study enrolled 22 patients: 14 EVAR and eight EVPLR patients. Owing to a technical issue during start up, the FORS system could not be used in one EVAR. The remaining 21 procedures proceeded without device or technology related complications and involved 66 navigational tasks. In 60 tasks (90.9%), technical success was achieved using at least one FORS enabled device. Users rated FORS based image guidance “better than standard guidance” in 16 of 21 and “equal to standard guidance” in five of 21 procedures. Fluoroscopy time ranged from 0.0 to 52.2 min. Several tasks were completed without or with only minimal X-ray use. Conclusion: Real time navigation using FORS technology is safe and feasible in abdominal and peripheral endovascular procedures. FORS has the potential to improve intra-operative image guidance. Comparative studies are needed to assess these benefits and potential radiation reduction.
AB - Objective: Endovascular procedures are conventionally conducted using two dimensional fluoroscopy. A new technology platform, Fiber Optic RealShape (FORS), has recently been introduced allowing real time, three dimensional visualisation of endovascular devices using fiberoptic technology. It functions as an add on to conventional fluoroscopy and may facilitate endovascular procedures. This first in human study assessed the feasibility of FORS in clinical practice. Methods: A prospective cohort feasibility study was performed between July and December 2018. Patients undergoing (regular or complex) endovascular aortic repair (EVAR) or endovascular peripheral lesion repair (EVPLR) were recruited. FORS guidance was used exclusively during navigational tasks such as target vessel catheterisation or crossing of stenotic lesions. Three types of FORS enabled devices were available: a flexible guidewire, a Cobra-2 catheter, and a Berenstein catheter. Devices were chosen at the physician's discretion and could comprise any combination of FORS and non-FORS devices. The primary study endpoint was technical success of the navigational tasks using FORS enabled devices. Secondary study endpoints were user experience and fluoroscopy time. Results: The study enrolled 22 patients: 14 EVAR and eight EVPLR patients. Owing to a technical issue during start up, the FORS system could not be used in one EVAR. The remaining 21 procedures proceeded without device or technology related complications and involved 66 navigational tasks. In 60 tasks (90.9%), technical success was achieved using at least one FORS enabled device. Users rated FORS based image guidance “better than standard guidance” in 16 of 21 and “equal to standard guidance” in five of 21 procedures. Fluoroscopy time ranged from 0.0 to 52.2 min. Several tasks were completed without or with only minimal X-ray use. Conclusion: Real time navigation using FORS technology is safe and feasible in abdominal and peripheral endovascular procedures. FORS has the potential to improve intra-operative image guidance. Comparative studies are needed to assess these benefits and potential radiation reduction.
KW - Endovascular navigation
KW - Endovascular surgery
KW - Fiber optic technology
KW - Imaging
KW - Radiation
KW - Three dimensional
UR - http://www.scopus.com/inward/record.url?scp=85097075051&partnerID=8YFLogxK
U2 - 10.1016/j.ejvs.2020.10.016
DO - 10.1016/j.ejvs.2020.10.016
M3 - Article
C2 - 33262088
AN - SCOPUS:85097075051
SN - 1078-5884
VL - 61
SP - 317
EP - 325
JO - European Journal of Vascular and Endovascular Surgery
JF - European Journal of Vascular and Endovascular Surgery
IS - 2
ER -