Radioprotection Measures during the Learning Curve with Hybrid Operating Rooms

Radioprotection Measures during the Learning Curve with Hybrid Operating Rooms

Accepted Manuscript Radioprotection Measures During The Learning Curve With Hybrid Operating Rooms L. Fidalgo Domingos, MD, E.M. San Norberto García, ...

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Accepted Manuscript Radioprotection Measures During The Learning Curve With Hybrid Operating Rooms L. Fidalgo Domingos, MD, E.M. San Norberto García, MD PhD, D. Gutiérrez Castillo, MD, C. Flota Ruiz, MD, I. Estévez Fernández, MD PhD, C. Vaquero Puerta, MD PhD. PII:

S0890-5096(18)30184-5

DOI:

10.1016/j.avsg.2017.12.010

Reference:

AVSG 3739

To appear in:

Annals of Vascular Surgery

Received Date: 31 August 2017 Revised Date:

7 December 2017

Accepted Date: 17 December 2017

Please cite this article as: Fidalgo Domingos L, San Norberto García E, Gutiérrez Castillo D, Flota Ruiz C, Estévez Fernández I, Vaquero Puerta C, Radioprotection Measures During The Learning Curve With Hybrid Operating Rooms, Annals of Vascular Surgery (2018), doi: 10.1016/j.avsg.2017.12.010. 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.

ACCEPTED MANUSCRIPT 1

RADIOPROTECTION MEASURES DURING THE LEARNING CURVE WITH

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HYBRID OPERATING ROOMS

3 Fidalgo Domingos L, MD; San Norberto García EM, MD PhD; Gutiérrez

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Castillo D, MD; Flota Ruiz C, MD; Estévez Fernández I, MD PhD; Vaquero

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Puerta C MD PhD.

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Department of Angiology and Vascular Surgery,

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Valladolid University Hospital, Spain

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Key

words:

Operating

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Procedures, Ionizing Radiation.

rooms,

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Radiation

Protection,

Endovascular

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There are no sources of financial support or competitive relationships that

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may pertain to the manuscript.

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Address for Correspondence:

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Liliana Fidalgo Domingos, M. D.

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Department of Angiology and Vascular Surgery, Valladolid University

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Hospital, Spain

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Calle Ramón y Cajal nº3, 47003. Valladolid. Spain. 0034-983420000.

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[email protected]

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ACCEPTED MANUSCRIPT Enrique M San Norberto García, M.D. Ph.D.

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Department of Angiology and Vascular Surgery, Valladolid University

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Hospital, Spain

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Calle Ramón y Cajal nº3, 47003. Valladolid. Spain. 0034-983420000.

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[email protected]

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31 Diana Gutiérrez Castillo, M.D.

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Department of Angiology and Vascular Surgery, Valladolid University

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Hospital, Spain

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Calle Ramón y Cajal nº3, 47003. Valladolid. Spain. 0034-983420000.

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[email protected]

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Cintia Flota Ruiz, M.D.

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Department of Angiology and Vascular Surgery, Valladolid University

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Hospital, Spain

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Calle Ramón y Cajal nº3, 47003. Valladolid. Spain. 0034-983420000.

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[email protected]

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Isabel Estévez Fernández, M.D. Ph.D.

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Department of Angiology and Vascular Surgery, Valladolid University

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Hospital, Spain

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Calle Ramón y Cajal nº3, 47003. Valladolid. Spain. 0034-983420000.

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[email protected]

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Carlos Vaquero Puerta, M.D. Ph.D.

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ACCEPTED MANUSCRIPT 51

Department of Angiology and Vascular Surgery, Valladolid University

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Hospital, Spain

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Calle Ramón y Cajal nº3, 47003. Valladolid. Spain. 0034-983420000.

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[email protected]

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RADIOPROTECTION MEASURES DURING THE LEARNING CURVE WITH

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HYBRID OPERATING ROOMS Abstract

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Background: Endovascular procedures come with a potential risk of radiation

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hazards both to patients and to the vascular staff. Classically, most

66

endovascular interventions took place in regular operating rooms using a

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fluoroscopy C-arm unit controlled by a third party. Hybrid operating rooms

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(HOR) provide an optimal surgical suit with all the qualities of a fixed C-arm

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device, while allowing the device to be controlled by the surgical team. The

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latest studies suggest that an operator-controlled system may reduce the

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radiation dose.

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The purpose of the present study is to determine the amount of absorbed

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radiation using a HOR in comparison with a portable C-arm unit and to assess

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whether the radioprotection awareness of the surgical team influences the

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radiation exposure. The primary endpoint was the effective dose in miliSievert

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(mSv) for the surgical team and the average dose-area-product (ADAP) in

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Gray-meters squared (Gym2) for patients.

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Methods: The values of absorbed radiation of the surgical team’s dosimeters

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were collected from January 2015 to May 2016. The HOR was installed in

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June 2015 and a radioprotection seminar was given in October 2015. The

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HOR issued radiation, measured by the maximum dose-area-product

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(MDAP), average dose-area-product (ADAP), average dose per procedure

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(AD), maximum dose per procedure per month (MD), maximum fluoroscopy

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time (MFT) average fluoroscopic time (AFT), peak skin dose (PSD) and

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average skin dose (ASD), was collected monthly from September 2015 to July

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ACCEPTED MANUSCRIPT 2016. The timeline was divided into three periods: 5 months pre-HOR (Pre-

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HOR), 5 months after the HOR installation (PreS-HOR) and 5 months after a

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radioprotection seminar (PostS-HOR).

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Results: The average number of procedures per month was 22,55 (±4,9),

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including EVAR/TEVAR, carotid, visceral and upper and lower limb

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endovascular revascularization.

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The average amount of absorbed radiation by the surgeons during PreS-HOR

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was 1,07±0,4mSv, which was higher than the other periods (Pre-HOR

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0,06±0,03mSv, p=0,002; PostS-HOR 0,14±0,09mSv, p=0,000, respectively).

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The ADAP during PreS-HOR was 0,016±0,01Gym2, which was lower than the

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PostS-HOR (0,001±0,002Gym2) (p=0,034). The AD during PreS-HOR was

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0,78±0,3Gy and 0,39±0,3Gy during PostS-HOR (p=0,098). The ASD during

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PreS-HOR was 0,40±0,2Gy and 0,20±0,1Gy during PostS-HOR (p=0,099).

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Conclusions: In our experience, the HOR increases the amount of absorbed

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radiation for both patients and surgeons. The radioprotection seminars are of

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utmost importance to provide a continued training and optimize the use of

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ionizing radiation while using and HOR. Despite the awareness of the surgical

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team in the radioprotection field, the amount of absorbed radiation using an

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HOR is higher than the one using a C-Arm unit.

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ACCEPTED MANUSCRIPT Introduction

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The first human implant of a fabric-covered stent took place in 1985 by

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Volodos, later in 1990 Parodi performed the first Endovascular Aneurysm

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Repair (EVAR) in the western world, opening a door to an endovascular

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era[1]. However, with this new technology comes a potential risk of radiation

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hazards, both to the patient and the vascular staff, and so its use should be

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ruled by the “as low as reasonably achievable” (ALARA) principle[2].

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Radiation exposure can lead to deterministic (direct tissue damage) or

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stochastic effects (gene mutation). Previous studies have shown that up to

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30% of EVAR procedures require a radiation dosage sufficient to cause

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deterministic effects[3,4]. Staff radiation dose can be monitored using

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dosimeters and minimized using various forms of X-ray shielding (led aprons,

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collars and glasses), image processing, shorter pulse duration and smaller

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focal spot size[5].

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Classically, most endovascular procedures take place in regular operating

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rooms (OR) using a fluoroscopy C-arm unit. As a remarkable progress has

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been made in this field over the past two decades, the classic C-arm has

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gotten short, with limited precision when it comes to fenestrated grafts or

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small vessel catheterizations and a limited time of use before overheating [6].

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Also, there is an increased tendency to perform “hybrid” procedures (partial

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open techniques associated with endovascular interventions) that ideally

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require an interventional suite associated with an operating room, commonly

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known as a “hybrid operating room” (HOR).

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ACCEPTED MANUSCRIPT The latest studies suggest that a system with an operator-controlled imaging,

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as an HOR, could be capable of reducing the radiation dose when compared

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to the classic C-arm unit[7].

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There are only a few studies that document the effect radiation dosage using

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a regular OR compared to a HOR with very limited inclusion criteria that do

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not represent the daily activity in a vascular OR.

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The purpose of the present study is to determine the amount of absorbed

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radiation using a HOR in comparison with a portable C-arm unit, by both the

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surgical team and the patient, and to assess whether the radioprotection

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awareness of the surgical team influences the radiation exposure.

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Materials and Methods

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Objectives and Endpoints

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The primary objective of this study is to determine the amount of absorbed

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radiation using a HOR in comparison with a portable C-arm unit, by both the

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surgical team and the patient. The primary endpoint was the effective dose in

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miliSievert (mSv) for the surgical team and the average dose-area-product

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(ADAP) in Gray-meters squared (Gym2) for patients. The secondary

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endpoints were maximum dose-area-product (MDAP) in Gym2, average (AD)

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and maximum dose per procedure (MD) in Gy, average (ASD) and peak skin

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dose (PSD) in Gy, average (AFT) and maximum fluoroscopy time (MFT) in

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minutes.

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Study Design

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The present study took place in an Angiology and Vascular Surgery

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Department at Valladolid University Hospital, a tertiary referral hospital. A

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radioprotection checklist took place before all interventions. All surgical

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ACCEPTED MANUSCRIPT personnel wore a dosimeter under their lead apron over the chest to all

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endovascular procedures regardless the operating room, and its data was

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collected retrospectively from January 2015 to March 2016. This period of

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time was chosen in order to provide data from both before and after the

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installation of the HOR. The HOR at our institution went in use in June 2015,

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thus all interventions performed before that time were identified as undergoing

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an endovascular procedure using a portable C-arm unit (OEC 9900 Plus

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Mobile C-arm; General Electric Healthcare, Fairfield, CT, USA) in two regular

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OR simultaneously. After the installation of the HOR (Artis Zeego; Siemens

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Healthcare, Erlangen, Germany) all endovascular procedures took place in

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the new operating suite.

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Upon the installation of the HOR at our center a dedicated seminar about the

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Siemens Artis Zeego device was given to all vascular personnel, before it

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went in use.

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Data from the all the elective endovascular procedures was recorded by the

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HOR device and collected retrospectively from its installation (June 2015) until

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March 2016. Since the installation of the HOR, all emergency endovascular

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interventions took place in a regular operating room with a mobile C-arm unit.

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Therefore, all emergency endovascular procedures were excluded from the

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present study.

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Both operating rooms were used to perform several types of endovascular

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peripheral procedures, such as thoracic and abdominal endovascular

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aneurysm repair (TEVAR and EVAR, respectively); iliac aneurysms and

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carotid, subclavian, visceral arteries, venous and lower limb angioplasty

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and/or stenting.

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ACCEPTED MANUSCRIPT Ionizing Radiation

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Patient intraoperative radiation dose is measured by the device and can be

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expressed with several parameters such as dose-area-product (DAP) defined

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as the absorbed dose multiplied by the irradiated area and expressed in gray-

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meters squared (Gym2) (we considered the maximum and the average DAP,

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MDAP and ADAP, respectively); dose per procedure as the total amount of

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radiation absorbed during an endovascular intervention measured in grays

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(Gy) (we considered the maximum and the average dose per procedure per

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month, MD and AD, respectively); fluoroscopy time that resumes the total time

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that fluoroscopy is used during an interventional procedure measured in

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minutes (we considered the maximum and the average fluoroscopic time, AFT

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and MFT, respectively); and skin dose (PSD) referring to dose absorbed at

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any portion of a patient’s skin during a procedure measured in Gy (we

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considered the peak skin dose and the average skin dose, PSD and ASD,

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respectively) [4,8-10].

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Although all surgical personnel had a Second Level Radioprotection

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Accreditation issued by the Spanish Ministry of Health, Social Services and

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Equality

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radioprotection seminar was given to the vascular staff in October 2015. The

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goal of this seminar was to review all the general radioprotection measures

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and means to reduce the radiation exposure, as using lead apparel, reducing

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detector-to-patient distance, limiting the fluoroscopy time, moving away of the

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source during digital subtraction angiography, maximal collimation and limiting

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angulations.

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to

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ACCEPTED MANUSCRIPT The timeline was divided in three periods: 5 months pre-HOR (Pre-HOR), 5

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months after the HOR installation (PreS-HOR) and 5 months after a

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radioprotection seminar (PostS-HOR).

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The variables of primary interest were: absorbed radiation dose by the staff

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dosimeters and the patient’s intraoperative radiation dose expressed as

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maximum dose-area-product (MDAP), average dose-area-product per month

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(ADAP), average dose per procedure per month (AD), maximum dose per

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procedure (MD), maximum fluoroscopy time (MFT) average fluoroscopic time

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(AFT), peak skin dose (PSD) and average skin dose (ASD).

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Interventional Procedures

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The same consultant vascular team, experienced in endovascular procedures

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and certified in radioprotection according to the European standards,

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performed all the interventions.

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Procedures were typically done under general or loco-regional anesthesia.

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The approach type (percutaneous or open) was dictated by the patient’s

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anatomical and clinical features. Low-dose fluoroscopy and high-dose digital

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acquisition were used according to the type of intervention. DAP was

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recorded by transmission ionization chambers. The HOR device also

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recorded the screening time automatically, and the time recorded represents

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the total for low-dose fluoroscopy and high-dose digital acquisition.

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General radioprotection tools were used during all procedures. Both operating

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rooms were provided with an architectural shielding built-in the walls as well

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as with ceiling-suspended shields constructed of a transparent leaded plastic

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and equipped-mounted shielding such as drapes suspended from the

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ACCEPTED MANUSCRIPT operating table. All personnel were equipped with thyroid shields, leaded

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eyeglasses and a vest-skirt apron of 0,25mm lead-equivalent.

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Besides the change in the OR and the radioprotection seminar, there was no

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change in the operative protocol during the study period.

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Statistical analysis

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Descriptive statistics were used to present mean values and standard

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deviation for continuous variables. Means were compared by unpaired two-

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tailed t-tests or Mann-Whitney U test. P<0.05 was considered significant. All

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calculations were performed with the SPSS statistical software package

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(version 20.0; IBM Corporation, Somers, NY, USA).

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Results

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From January 2015 to April 2016, 478 patients underwent an elective

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endovascular procedure. Of these 162 patients had their intervention prior to

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the HOR (Pre-HOR) and 316 after its installation, 174 during PreS-HOR and

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142 during PostS-HOR periods. The average number of procedures per

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month was 21(±7) and 22,89(±4,8) during the PreS-HOR and PostS-HOR,

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respectively, (Table 1, Figure 1).

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The average amount of absorbed radiation by the surgical team during PreS-

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HOR was 1,07±1,4mSv, which was significantly higher than the other two

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periods (Pre-HOR 0,06±0,03mSv, p=0,002; PostS-HOR 0,14±0,09mSv,

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p=0,000, respectively). Representing 18 times more radiation during the

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PreS-HOR period then the Pre-HOR period, and 8 times more then the

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PostS-HOR (Table 2).

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During the PreS-HOR the maximum dose-area-product (MDAP) was

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0,145(±0,09) Gym2 and the average dose-area-product (ADAP) was

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ACCEPTED MANUSCRIPT 0,016(±0,01) Gym2, showing a significant decrease during the following

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period of PostS-HOR, of 75% with an MDAP of 0,036(±0,02) Gym2 (p=0,004)

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and 62.5% with an ADAP of 0,006(±0,002) Gym2 (p=0,005).

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Although there were no significant differences in terms of average dose per

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procedure (AD) during PreS-HOR and PostS-HOR, with 0,78±0,3Gy and

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0,39±0,3Gy each (p=0,137); the maximum dose per procedure (MD) was

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approximately 3 times higher during PreS-HOR when compared to PostS-

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HOR, with 7,20(±3,0) Gy and 2,57(±1,6) Gy during each period (p=0,001).

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The average skin dose (ASD) showed a tendency to decrease during PostS-

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HOR (0,20±0,1Gy) in comparison to the previous period of PreS-HOR

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(0,40±0,2Gy), p=0,055; while the peak skin dose (PSD) presented no

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significant differences during the two periods (PreS-HOR 1,75±0,9Gy and

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PostS-HOR 1,06±0,9Gy, p=0,363).

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There were no significant differences in terms of average fluoroscopy time

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(PreS-HOR 19,78±0,5 minutes and PostS-HOR 19,30±0,1 minutes, p=0,913)

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or maximum fluoroscopic time (PreS-HOR 84,22±28,5 minutes and PostS-

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HOR 82,35±35,0 minutes, p=0,946).

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Discussion

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The use of ionizing radiation to perform endovascular procedures is

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nowadays inevitable and so are its potential undesirable effects, both to the

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patient and to the surgical team. Therefore minimizing the radiation dose

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during interventional procedures is a “win-win” situation, benefiting both the

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patient and the surgical team. In order to do so, it’s of utter importance

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minimizing the fluoroscopy time as well as the number of fluorographic

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images, use collimation and all available information to plan the interventional

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ACCEPTED MANUSCRIPT procedure. Likewise, the surgical team should have general knowledge of

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safe operating practices in a radiation environment and be equipped with a

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dosimeter and wear protective shielding (leaded aprons, eyewear and thyroid

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shields)[12].

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Most endovascular procedures are typically performed under two-dimensional

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(2D) fluoroscopy imaging, which not only may be insufficient to carry out

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complex interventions, but also imply a higher radiation dose to carry out the

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procedure. The HOR combines an optimal surgical suit with the advanced

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imaging capabilities of a fixed system, including more tube power with less

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overheating issues, flat-panel detectors, customizable x-ray dose levels,

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three-dimensional (3D) acquisition through a C-arm rotation around the

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patient and preoperative CT angiography (CTA) images fusion. Both 3D

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acquisition and CTA images can be used as a road map during fluoroscopy,

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minimizing the radiation dosage per intervention [13-15].

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Although many authors have compared the amount of radiation exposure

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using a C-arm portable unit to a HOR during certain types of interventions,

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little work has been done in terms of overall radiation exposure of an

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interventional suite regular use.

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The ADAP values found in our study were 16mGym2 and 6mGym2, during

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PreS-HOR and PostS-HOR respectively, which are comparable to the ones

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found by Weerakkody et al[16] (15mGym2) and Geijer et al[17] (7,23mGym2).

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Nonetheless, both studies were performed exclusively with bifurcated EVAR,

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while our results refer to a much wide range of interventions where EVAR

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represents only 19% of all procedures performed.

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ACCEPTED MANUSCRIPT Peach et al[7] studied 122 patients that underwent an aortic endovascular

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repair and found a significant decrease on ADAP from 6,9mGym2 to

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4,9mGym2, after the installation of an operator-controlled imaging system,

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representing a 29% reduction in terms of patient absorbed radiation. Our

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study showed an overall increase of the absorbed radiation even after the

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radioprotection seminar. The ADAP suffered a 62.5% reduction after a

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radioprotection seminar that was given to the surgical staff, defining the

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radioprotection awareness of the surgical team as a fundamental key to

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reduce the radiation exposure. During our study the absorbed radiation by the

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surgeons’ dosimeters, increased up to 18 times after the installation of the

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new HOR suite. What is more striking is that even though the absorbed

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radiation dropped following a radioprotection seminar, it has never reached

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the initial radiation exposure. It is not new that a mobile C-arm reduces the

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radiation dose compared to a fixed C-arm, this could be due to a better image

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quality that can be obtained from the new device, at cost of a higher radiation

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dosage. Our results agree with the work of Guillou et al.[18], who studied two

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series of patients with peripheral arterial disease treated with an endovascular

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procedure, either at a HOR or with a mobile C-arm unit, and observed that the

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HOR with a fixed C-arm offered better image quality at the expense of a

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higher radiation dose to the patients. Also, Kendrick et al.[19] studied 116

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endovascular procedures performed with a HOR or with a fixed C-arm unit

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and concluded that the scattered radiation using a fixed imaging system (like

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an HOR) is several-fold times higher then with a mobile C-arm unit,

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suggesting that additional strategies to minimize exposure and occupational

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risk are needed.

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ACCEPTED MANUSCRIPT In our study, the initial peak of radiation exposure could be related to the

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installation of the new equipment, which, passed the learning curve, should

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have been normalized. Instead, it remained higher than the radiation

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exposure previous to the HOR installation. Nonetheless, the abrupt decrease

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of absorbed radiation that followed the radioprotection seminar raises

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concerns about the importance of periodic recertification in radioprotection of

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the surgical team.

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Limitations

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This report involves a single-center experience, with a potential bias existing

338

because of the relatively small number of cases involved.

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The post-seminar period considered was 6 months; maybe longer intervals

340

could modify the results. So, further investigations need to evaluate the long-

341

term follow-up and radiation dosage.

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Since the collected data is not related to specific procedures, our results do

343

not allow us to draw a conclusion in terms of radiation issued per procedure.

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Further studies should be considered to investigate the relationship between

345

procedures and issued radiation, in order to decide which ones should take

346

place at an HOR and which ones could benefit from the mobile C-arm unit.

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Conclusion

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In our experience, the HOR increases the amount of absorbed radiation for

349

both patients and surgeons. The radioprotection seminars are of utmost

350

importance to provide a continued training and to optimize the use of ionizing

351

radiation while using and HOR. Despite the awareness of the surgical team in

352

the radioprotection field, the amount of absorbed radiation using an HOR is

353

still higher than the one using a C-Arm unit.

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References

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1.

Parodi JC, Palmaz JC, Barone HD. Transfemoral intraluminal graft implantation for abdominal aortic

357

1991;5:491–9.

358

2.

aneurysms.

Ann

Vasc Surg

RI PT

356

Hertault A, Maurel B, Midulla M, et al. Editor's Choice - Minimizing Radiation

360

Knowledge, Literature Review, and Reporting Standards. Eur J Vasc

361

Endovasc Surg 2015;50:21–36. 3.

Endovascular

Procedures:

Basic

Weerakkody RA, Walsh SR, Cousins C, et al. Radiation exposure during endovascular aneurysm repair. Br J Surg 2008;95:699–702.

363

364

During

M AN U

362

Exposure

SC

359

4.

Jaco JW, Miller DL. Measuring and Monitoring Radiation Dose During Fluoroscopically Guided Procedures. Techniques in Vascular and

366

Interventional Radiology 2010;13:188–93.

367

5.

TE D

365

van den Haak RFF, Hamans BC, Zuurmond K, et al. Significant Radiation Dose Reduction in the Hybrid Operating Room Using a Novel

369

X-ray Imaging Technology. European Journal of Vascular and

370

Endovascular Surgery 2015;50:480–6.

6.

Varu VN, Greenberg JI, Lee JT. Improved efficiency and safety for

EVAR with utilization of a hybrid room. Eur J Vasc Endovasc Surg

372

2013;46:675–9.

373

374

AC C

371

EP

368

7.

Peach G, Sinha S, Black SA, et al. Operator-controlled Imaging

375

Significantly Reduces Radiation Exposure during EVAR. European

376

Journal of Vascular and Endovascular Surgery 2012;44:395–8.

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8.

Stecker MS, Balter S, Towbin RB, et al. Guidelines for Patient Radiation

378

Dose Management. Journal of Vascular and Interventional Radiology

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2009;20:S263–73. 9.

Kim S, Toncheva G, Anderson-Evans C, et al. Kerma area product

RI PT

380 381

method for effective dose estimation during lumbar epidural steroid

382

injection

383

2009;192:1726–30. 10.

phantom

study.

AJR

Am

J

Roentgenol

SC

384

procedures:

International Commission on Radiation Units and Measurements. Report 85: Fundamental quantities and units for ionizing radiation. J

386

ICRU 2011;11:1–31.

M AN U

385

11.

Smith PH. EC Directive: 97/43/Euratom. Br J Radiol 1998;71:108–8.

388

12.

Miller DL, Vañó E, Bartal G, et al. Occupational Radiation Protection in

TE D

387

Interventional Radiology: A Joint Guideline of the Cardiovascular and

390

Interventional Radiology Society of Europe and the Society of

391

Interventional Radiology. Cardiovasc Intervent Radiol 2009;33:230–9.

393 394

395

13.

Markelj P, Tomaževič D, Likar B, et al. A review of 3D/2D registration

AC C

392

EP

389

methods for image-guided interventions. Med Image Anal 2012;16:642– 61.

14.

Stahlberg E, Planert M, Panagiotopoulos N, et al. Pre-operative

396

Simulation of the Appropriate C-arm Position Using Computed

397

Tomography

398

Contrast Medium Exposure During EVAR Procedures. European

399

Journal of Vascular and Endovascular Surgery 2017;53:269–74.

Post-processing

Software

Reduces

Radiation

and

17

ACCEPTED MANUSCRIPT 400

15.

de Ruiter QMB, Reitsma JB, Moll FL, et al. Meta-analysis of Cumulative

401

Radiation Duration and Dose During EVAR Using Mobile, Fixed, or

402

Fixed/3D Fusion C-Arms. J. Endovasc. Ther. 2016;23:944–56.

during endovascular aneurysm repair. Br J Surg 2008;95:699–702.

404

17.

of abdominal aortic aneurysms. Br J Radiol 2005;78:906–12.

406

407

Geijer H, Larzon T, Popek R, et al. Radiation exposure in stent-grafting

18.

SC

405

Weerakkody RA, Walsh SR, Cousins C, et al. Radiation exposure

RI PT

16.

Guillou M, Maurel B, Necib H, et al. Comparison of Radiation Exposure

M AN U

403

408

during Endovascular Treatment of Peripheral Arterial Disease with Flat-

409

Panel Detectors on Mobile C-arm versus Fixed Systems. Ann Vasc

410

Surg 2017; 19.

Kendrick

DE,

Miller

CP,

Moorehead PA,

et

al.

Comparative

TE D

411

occupational radiation exposure between fixed and mobile imaging

413

systems. J. Vasc. Surg. 2016;63:190–7.

415

AC C

414

EP

412

18

ACCEPTED MANUSCRIPT Tables and Figures

417

Figure 1: Endovascular procedures performed during the study follow-up. Pre

418

hybrid operating room installation (Pre-HOR), after the HOR installation

419

(PreS-HOR) and after the radioprotection seminar (PostS-HOR).

RI PT

416

420 200

Miscellanea

180

SC

Venous PTA-Stent Embolization

160

Bypass PTA-Stent

140

M AN U

Distal PTA-Stent

120 100 80 60

20 0

423

424 425

Iliac PTA-Stent Renal PTA-Stent Mesenteric PTA-Stent Subclavian PTA-Stent Carotid Stent Complex EVAR Iliac Branch TEVAR EVAR

PostS-HOR

AC C

422

PreS-HOR

Femoral PTA-Stent

EP

Pre-HOR

421

TE D

40

Popliteal PTA-Stent

19

ACCEPTED MANUSCRIPT 426

Table 1: Interventions per period of time. During the study period 478

427

procedures were performed, 316 (66,1%) of which took place in the Hybrid

428

Operating Room (HOR).

431

432

433 434

SC

24 3 2 3 2 2 0 2 35 41 1 14 0 10 1 2 142

M AN U

31 1 3 4 7 6 1 3 39 52 5 11 3 4 2 1 174

89 8 7 8 9 13 8 9 103 140 9 37 4 25 3 6 478

AC C

430

34 4 2 1 0 5 7 4 28 47 3 12 1 11 0 3 162

TOTAL OF PostS-HOR INTERVENTIONS

EP

EVAR TEVAR Iliac Branch Complex EVAR Carotid Stent Subclavian PTA-Stent Mesenteric PTA-Stent Renal PTA-Stent Iliac PTA-Stent Femoral PTA-Stent Popliteal PTA-Stent Distal PTA-Stent Bypass PTA-Stent Embolization Venous PTA-Stent Miscellanea TOTAL

Pre-HOR

PERIOD PreS-HOR

TE D

PROCEDURE

RI PT

429

20

ACCEPTED MANUSCRIPT Table 2: Continuous variables analysis.

ADAP (Gym2)

0,649

1,07 (±1,4)

0,14 (±0,09)

0,000

0,145 (±0,09) 0,016 (±0,01) 0,78 (±0,3) 7,20 (±3,0) 0,40 (±02) 1,75 (±0,9) 19,78 (±0,5) 84,22 (±28,5)

0,036 (±0,02) 0,006 (±0,002) 0,39 (±0,3) 2,57 (±1,6) 0,20 (±0,1) 1,06 (±0,9) 19,30 (±0,1) 82,35 (±35,0)

M AN U

AD (Gy) MD (Gy) ASD (Gy) PSD (Gy) AFT (minutes) MFT (minutes)

p

RI PT

Average number of procedures (per month) Average amount of radiation absorbed by the surgical team (mSv) MDAP (Gym2)

PERIOD PreS-HOR PostS-HOR 21 (±7) 22,89(±4,8)

0,005

0,137 0,001 0,055 0,363 0,913 0,946

AC C

EP

TE D

437

0,004

SC

435 436

21