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Peroperative Intravascular Ultrasound for Endovascular Aneurysm Repair versus Peroperative Angiography: A Pilot Study in Fit Patients with Favorable Anatomy
Journal Pre-proof Peroperative Intravascular Ultrasound for Endovascular Aneurysm Repair vs. Peroperative Angiography: A pilot study in fit patients with favorable anatomy. Giulio Illuminati, Maria Antonietta Pacilè, Gianluca Ceccanei, Massimo Ruggeri, Giuseppe La Torre, Jean-Baptiste Ricco PII:
S0890-5096(19)30975-6
DOI:
https://doi.org/10.1016/j.avsg.2019.11.013
Reference:
AVSG 4776
To appear in:
Annals of Vascular Surgery
Received Date: 10 September 2019 Revised Date:
4 November 2019
Accepted Date: 5 November 2019
Please cite this article as: Illuminati G, Pacilè MA, Ceccanei G, Ruggeri M, La Torre G, Ricco JB, Peroperative Intravascular Ultrasound for Endovascular Aneurysm Repair vs. Peroperative Angiography: A pilot study in fit patients with favorable anatomy., Annals of Vascular Surgery (2019), doi: https:// doi.org/10.1016/j.avsg.2019.11.013. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. 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. © 2019 Published by Elsevier Inc.
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Peroperative Intravascular Ultrasound for Endovascular Aneurysm Repair vs. Peroperative
3
Angiography: A pilot study in fit patients with favorable anatomy.
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Giulio Illuminati*, Maria Antonietta Pacilè*, Gianluca Ceccanei*, Massimo Ruggeri*, Giuseppe La
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Torre§, Jean-Baptiste Ricco†
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* Department of Surgical Sciences, University of Rome “La Sapienza”, Rome, Italy
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§ Department of Public Health and Epidemiology, University of Rome “La Sapienza”, Rome, Italy
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† University of Poitiers, CHU de Poitiers, Department of Clinical Research, Poitiers, France
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Presented at the 33rd Annual Meeting of the French Society for
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Vascular and Endovascular Surgery, Nice, France, June 29 to July
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2, 2018.
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Correspondence:
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Giulio Illuminati The Department of Surgical Sciences University of Rome “La Sapienza”, Rome, Italy Policlinico Umberto Primo Viale del Policlinico 00161 Rome, Italy E-mail: [email protected] Phone/Fax: + 39 06 49 97 06 42
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Word count: 2917
29 30 1
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ABSTRACT
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Objectives
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The aim of this study was to compare intravascular-ultrasound (IVUS) assistance for Endovascular
35
Aortic Aneurysm Repair (EVAR) to standard assistance by angiography.
36
Methods
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From June 2015 to June 2017, 173 consecutive patients underwent EVAR. In this group, 69
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procedures were IVUS-assisted with X-ray exposure limited to completion angiography for safety
39
purposes because IVUS probe does not yet incorporate a duplex probe (group A), and 104
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angiography-assisted procedures (group B). All IVUS-assisted procedures were performed by
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vascular surgeons with basic duplex ultrasound (DUS) training. The primary study endpoints were
42
mean radiation dose, duration of fluoroscopy, amount of contrast media administered, procedure-
43
related outcomes, and renal clearance expressed as the glomerular filtration rate (GFR) before and
44
after the procedure. Secondary endpoints were operative mortality, morbidity, and arterial access
45
complications.
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Results
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Mean duration of fluoroscopy time was significantly lower for IVUS-assisted procedures (24 ± 15
48
minutes vs. 40 ± 30 minutes for angiography-assisted procedures, p < .01). Moreover, mean
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radiation dose (Air KERMA) was significantly lower in IVUS-assisted procedures [76m Gy (44–
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102) vs. 131 mGy (58–494)], p <.01.IVUS-assisted procedures required fewer contrast media
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compared to standard angiography-assisted procedures (60 ± 20 ml vs. 120 ± 40 ml, p < .01). Mean
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duration of the procedure was comparable in the two groups (120 ± 30 minutes vs. 140 ± 30
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minutes, p = 0.07). No difference in renal clearance before and after the procedure was observed in
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either of the two groups (99.0 ± 4/ 97.8 ± 2 ml/min in group A and 98.0±3/97.6 ±5 ml/min in group
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B (p = 0.28).Mean length of follow-up was 9 months [6–30 months]. No postoperative mortality,
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morbidity or arterial access complications occurred. No type 1 endoleak was observed. Early type II 2
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endoleaks were observed in 21 patients (11%), 12 in the angiography-assisted group (11%) and 9 in
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the IVUS-assisted group (12%). They were not associated with sac enlargement ≥ 5 mm diameter
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and therefore did not require any additional treatment.
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Conclusions
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Compared to standard angiography-assisted EVAR, IVUS significantly reduces renal load with
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contrast media, fluoroscopy time and radiation dose, while preserving endograft deployment
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efficiency. Confirmation from a large prospective study with improved IVUS
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probes will be required before IVUS-assisted EVAR alone can become standard practice.
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Key Words: Endovascular aortic repair, intravascular ultrasound, abdominal aortic aneurysm
68 69 70 71 72 73 74 75 76 77 78
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INTRODUCTION
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As endovascular aneurysm repair (EVAR) has become a standard method of treatment for
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abdominal aortic aneurysm (AAA), potential kidney injury and allergy induction [1,2], the amount
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of contrast media used during angiography-assisted procedures has arisen as an issue, as have the
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risks related to X-ray exposure during fluoroscopy, for both patients and surgeons [3–8]. While
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CO2-assisted angiography eliminates the risk of contrast media-induced nephropathy, it does not do
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away with the risks related to fluoroscopy time [9–10].
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Fusion imaging with road mapping seems to offer a promising alternative means of reducing
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radiation exposure in both simple and complex endovascular aneurysm repair [11–16]. It has also
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been applied in the settings of endoleak treatment and carotid stenting [17]. But up until now, even
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though new cloud-based technology seems able to provide fusion imaging with overlapping on
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mobile C-arms, fusion imaging is available only in expensive, hybrid suites [18].
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Following recent technological advances, endovascular ultrasound (IVUS) has become highly
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reliable in providing immediate intraoperative imaging of the aorta and its branches, including iliac
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artery bifurcation. IVUS has also been shown to allow accurate assessment of proximal and distal
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landing zones of an aortic endograft [19–22]. Compared to angiography-assisted procedures,
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besides reducing the risk of contrast media-induced nephropathy, EVAR assisted by IVUS could
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provide the further advantage of reducing fluoroscopy time and exposure to radiation, for the
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patient and the surgeon, without lowering the accuracy of the procedure.
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To confirm this hypothesis, we retrospectively reviewed our experience with EVAR, comparing
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IVUS-assisted and standard angiography- assisted procedures.
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MATERIAL AND METHODS
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From June 2015 to June 2017, 173 consecutive patients, including 142 males of a mean age of 70
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years [42 to 88 years] underwent EVAR at an academic tertiary care hospital and an affiliated
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vascular surgery center. In this series, AAA included standard infrarenal aneurysms with the
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exclusion of pararenal, or juxtarenal aneurysm amenable to the chimney technique. All the patients 4
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gave written consent for both procedures (IVUS-assisted and standard angiography-assisted EVAR)
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and their records were retrospectively reviewed for the purposes of the present study, for which,
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given its retrospective nature, ethics committee approval was waived.
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Concerning data protection, patients were identified in the case report form (CRF) by a code
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composed of their initials, an assigned number, and the center number. This code was the only
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information in the CRF enabling a retrospective link with a patient’s identity. Patient medical data
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was provided only to the authors, and, when applicable and in strict confidence, to authorized health
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authorities. Supervisory authorities could request direct access to medical records for the purposes
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of verification of the procedures and/or data in respect of the study, within the limits authorized by
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the relevant legislation and regulations. The data compiled during the study were processed in
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compliance with all requirements of the EU data protection authority.
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None of the patients included in this study presented renal insufficiency defined as serum creatinine
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concentration > 120 mmol/dl and estimated glomerular filtration rate (GFR) < 90mL/min. Patients
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with impaired renal function or renal insufficiency were systematically treated with IVUS-assisted
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procedures and therefore excluded from the present study. Besides renal insufficiency, further
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exclusion criteria included thoraco-abdominal, supra-and juxtarenal aneurysms. In order to avoid
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any further bias, patients with angulated (> 60°), short (<1.5 cm), thrombus-lined or severely
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calcified infrarenal aneurysm neck were likewise excluded (Table 1) [23–24]. In short, exclusion
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criteria pertained to all patients with AAA not amenable to a standard endovascular treatment.
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Patients in whom the indication for EVAR was rendered necessary due to severe comorbidities
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contraindicating open surgical repair were also excluded. (Figure 1). As only patients with normal
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renal function were included in the study, no special renal protection was applied in any of them.
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According to imaging assistance, the patients were divided into 2 groups. In 69 patients (group A),
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all procedures were IVUS-assisted, whereas in 104 patients (group B) all procedures were
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angiography-assisted. The choice of imaging assistance was left to the surgeon’s preference, and all
5
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IVUS- assisted procedures were performed by vascular surgeons who had received basic DUS
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training and were supported by a tutor during the first 5 EVAR IVUS-assisted cases.
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In this study, all patients in both groups underwent a final control angiography in order to identify
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any type I endoleak. In group A, completion angiography was required due to the fact that the 0.35
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IVUS probe, the only probe allowing complete imaging of the aorta and its branches, does not
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incorporate a chromoflow Doppler probe. While smaller 0.14 and 0.18 catheter probes indeed
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incorporate a chromoflow, their resolution is limited to coronary and lower limb arteries and
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consequently not usable for the placement of an aortic endograft [R3, Q3]. In this study, two types
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of C-arm were used, General Electric OEC 9800 Plus (General Electric OEC Medical Systems Inc.,
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Salt Lake City, UT, USA) and General Electric Innova 4100 (General Electric Medical Systems
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Inc., Salt Lake City, UT, USA). Measurement of absorbed radiation doses for both C-arms was
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carried out with a Diamentor M4 – KDK detector (PTW, Freiburg, Germany) in order to eliminate
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any possible error in dose measurement related to the type of C-arm.
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Preoperative imaging consisted of a spiral angio-CT-scan with central lumen line to assess
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aneurysm diameter, length of the aneurysmal neck and diameter of outflow arteries in view of
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deciding on the optimal endovascular strategy and suitable endograft choice.
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Arterial access was achieved through a femoral artery cutdown in 28 patients in group A and in 55
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patients in group B and percutaneously in 46 patients in group A and in 59 patients in group B.
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Percutaneous femoral access was closed with a single PercloseProGlide ® SMC device (Abbott
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Vascular, Santa Clara, CA, USA) for sheaths of diameter not exceeding 11 Fr and with two devices
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for sheaths of 12 to 21 Fr diameter.
151
For abdominal, IVUS- assisted procedures, after gaining femoral access and sheath introduction, the
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IVUS probe (Volcano Vision ®PV 8.2 Fr) [Volcano Japan Inc., Tokyo, Japan] was advanced over a
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Terumo standard guidewire (Terumo Corporation ®, Tokyo, Japan) or over a stiff guidewire above
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the diaphragm and pulled back to locate the ostia of the celiac trunk, superior mesenteric artery, left
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renal vein and renal arteries (Figure 2, Video 1). The position of the lower renal artery was marked 6
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over the fluoroscopic monitor, and the probe was then pulled back again to identify the ostium of
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the ipsilateral hypogastric artery. At this point, the reliability of IVUS – assessed data (diameter of
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proximal and distal neck/landing zone, neck quality including eventual calcifications and thrombus)
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with regard to those assessed by a CT scan was verified, and the main body of the endograft was
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deployed. The IVUS probe was subsequently advanced through the contralateral femoral access to
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reach the gate (Fig. 3) and assess the diameter and length of the contralateral limb of the graft and
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the optimal landing zone. After complete deployment of the endograft, completion angiography was
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systematically performed to verify the patency of renal and hypogastric arteries and to rule out the
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presence of any type I endoleak. In all cases we were able to identify the main arterial landmarks
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for endograft deployment with IVUS.
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Within a month after discharge from the hospital, all of the patients underwent CT scan of the
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thoracic and abdominal aorta followed by contrast-enhanced ultrasound every six months together
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with CTscan of the abdominal aorta at 24 months. Mean length of follow-up was 9 months [6–30
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months].
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The primary endpoints of the study were mean duration of fluoroscopy and radiation dose, amount
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of contrast media administered (mL), renal clearance expressed as the estimated GFR, before and
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after the procedure, and incidence of primary type 1 endoleak. The radiation dose was expressed in
173
terms of KERMA (Kinetic Energy Released per unit of Matter), mGy. Secondary endpoints were
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arterial access complications and type II endoleaks.
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Risk factors
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Hypertension was defined as any condition requiring antihypertensive drug(s), dyslipidemia as
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serum triglyceride level > 150 mg/dL and/or cholesterol level >220 mg/dL, coronary artery disease
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as clinical, electrical evidence of coronary artery disease or previous coronary artery
179
revascularization, and peripheral arterial disease as any clinical evidence of peripheral artery
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obstructive disease or previous peripheral artery revascularization.
181 7
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Statistical analysis
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Frequency distributions were performed. All recorded data had a normal distribution, assessed by
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the Kolmogorov–Smirnov test. Differences among the patients for the variables considered as
185
endpoints were assessed using the paired Student t-test. Differences between patients were tested
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using the independent samples t-test. Differences for qualitative variables were assessed using the
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chi-square test. Statistical analysis was carried out using the SPSS software for Windows,
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release 25.0. Statistical significance was set at p value < .05.
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RESULTS
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Demography and risk factors were comparable in the two groups (Table 2). Overall, mean duration
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of hospitalization was 3 days (range 2–6 days), including cutdown and percutaneous femoral
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procedures over the duration of the study (5 years). For most recent patients, the length of
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postoperative stay for uncomplicated percutaneous procedures in the series was 24 hours. Overall,
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body mass index (BMI), differences which could affect measurement of radiation absorbed dose,
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was comparable in the two groups: (group A, BMI: 27.01, [range, 21.1-34.8] vs. group B,
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BMI: 26.6 [range, 20.4-34.0] (p = .73).
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All in all, 173 patients underwent standard EVAR procedure forinfrarenal AAA (group A, n = 69;
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group B, n= 104), in 6 patients, unilateral hypogastric artery embolization with external iliac artery
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landing was required for an aneurysm involving the iliac artery bifurcation (group A, n = 4; group
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B, n= 2). The endograft was a Gore Excluder endograft (WL Gore and ass., Flagstaff, AZ, USA) in
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109 patients (n =47 in group A and n = 62 in group B) and a Bolton Treo endograft (Bolton
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Medical®, Sunrise, FL, USA) in 64 patients (n=30 in group A and n=34 in group B). All
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procedures were performed under local anesthesia and sedation. Twenty-two patients in group A
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and 16 patients in group B were operated under dual antiplatelet treatment (100 mg oral
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Aspirin/day + 75 mg oral Clopidogrel/day) due to recent (< 6 months) percutaneous coronary
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angioplasty with drug-eluting stent implantation. The remaining patients underwent the procedure
8
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under single antiplatelet treatment (100 mg oral Aspirin/day). All patients received statins (40 mg
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oral atorvastatin/day) starting at least one week before the procedure.
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Primary Endpoints
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Mean duration of fluoroscopy was significantly lower in group A (24 ± 15 minutes) compared to
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group B (40 ± 30 minutes, p < .01). Moreover, radiation dose was significantly lower in group A
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compared to group B [76 mGy (44–102) vs. 131 mGy (58–494), p <.01]. Patients in group A
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required significantly less contrast agent compared to those in group B (60 ± 20 ml vs. 120 ± 40 ml,
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p < .01). Accuracy for endograft positioning with IVUS guidance was comparable to that obtained
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with angiography guidance as shown on completion angiography. No type 1A or type 1B primary
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endoleak occurred in this series due to precise location of the renal arteries and internal iliac arteries
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following IVUS guidance.
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The overall, mean duration of the procedure for aneurysm repair was comparable in groups A and B
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(120 ± 30 minutes vs. 140 ± 30 minutes respectively, p = .07). No significant change of renal
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clearance before and after the procedure (99.0 ± 4 and 97.8 ± 2 ml/min in group A and 98.0 ± 3 and
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97.6 ± 5 ml/min in group B) was found in either group (p = .28) [Table 3].
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Secondary Endpoints
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No postoperative mortality, morbidity or arterial access complication was observed in either group.
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No conversion to open surgery, aorto-mono-iliac endografting or significant modification of the
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planned procedure was required.
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Type II endoleaks were observed in 21 patients, 9 (12%) in group B and 12 (11%) in group A. None
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of these endoleaks were followed by aneurysm sac enlargement ≥ 5 mm during follow-up and no
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additional treatment was required. No late, type II endoleak was observed in either group.
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DISCUSSION
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The results of this study show that compared to standard angiography-assisted EVAR, IVUS-
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assisted EVAR significantly reduces the load of contrast media and duration of fluoroscopy.
9
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Compared to earlier probes [20], present-day IVUS probes are highly reliable, simple to manipulate
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for any vascular surgeon with basic knowledge of DUS with a short learning curve of fewer than 5
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cases. Due to technical evolution, initial problems and limitations of IVUS-assistance for EVAR
235
[20,22,24,25] can now be considered as resolved.
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In agreement with results reported in previous studies [23, 25], IVUS was more efficient than
237
angiography in locating the ostia of the hypogastric arteries, without the problem of parallax in
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antero-posterior view of angiography, which necessitates multiple projections.
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Although not reducing operative time and blood loss compared to angiography, our study, in
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agreement with others, [20–22] demonstrated that IVUS assistance provided significant reduction of
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contrast media volume, which could certainly be beneficial for patients with renal failure, even
242
though neither the previous studies nor the present one have assessed its role in this respect. Given
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that up to 30% of candidates for EVAR may present chronic renal failure [26] and given that
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worsened renal function due to contrast agent injection may significantly prolong hospital stay and
245
increase the need for medications [27] IVUS-assisted procedures are of increasing interest.
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Although post-procedure renal insufficiency has also been reported with IVUS-assisted EVAR [28],
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it is very likely that this finding was more connected to renal artery embolism during catheterization
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and proximal aortic neck maneuvering [21]. When dealing with a shaggy aorta, possible
249
displacement of thrombotic material from the aortic wall or aneurysmal sac with the IVUS probe
250
was one of our initial concerns when starting this technique. However, after the first cases, we
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realized that there was little or no cause for concern. In our experience, IVUS was not associated
252
with any clinical distal embolism. On the contrary, the IVUS probe enabled us to obtain detailed
253
imaging of the intraluminal aortic thrombus, allowing careful introduction and navigation of
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guidewires in patients with shaggy aorta. Some previous studies have proposed fully free contrast
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media for IVUS-assisted EVAR, thereby avoiding completion angiography [19, 29] but running the
256
risk of missing a possible type I endoleak. We would not yet recommend this option. Missing a type
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I endoleak would expose the patient to a high risk of aneurysm rupture. A possible alternative to 10
258
completion angiography could consist in the use of contrast-enhanced ultrasound for EVAR [28].
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However, given the availability in the near future of a Doppler incorporated in the IVUS probe, the
260
need for completion angiography or contrast-enhanced ultrasound will be reduced, and contrast
261
media-free procedures may become standard.
262
Carbon dioxide (CO2) angiography has also been used for EVAR in patients with renal
263
insufficiency [9,10,30]. Its main advantage over IVUS is its sensitivity in detecting endoleaks due
264
to the low viscosity of CO2 media [22]. However, the quality of CO2 angiography imaging is
265
questionable, particularly in patients with severe artery calcifications with a need for long
266
fluoroscopy times to obtain satisfactory control imaging [9]. It should also be observed that
267
candidates for EVAR currently undergo preoperative and postoperative CT-scans in which the total
268
contrast media amount may largely overwhelm the quantity of contrast medium required for
269
standard, angiography-assisted EVAR. Nonetheless, a future study comparing IVUS-assisted to
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CO2 angiography- assisted procedures and evaluating IVUS with CO2 angiography assistance
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would be interesting as a means of validating the relative value of these imaging techniques.
272
According to a recent experiment, cloud 260-based technology fusion imaging, also available for
273
mobile C-arms, may compete with IVUS to significantly reduce radiation exposure during EVAR
274
[18]. However, in this study by Maurel et al. on 44 patients undergoing fusion-assisted EVAR
275
compared with 21 angiography-assisted controls, fusion imaging did not eliminate the need for
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angiography, particularly prior to infrarenal endograft deployment, nor did it shorten total
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fluoroscopy time. Moreover, no information was provided by the authors concerning the total
278
amount of contrast media administered in the two groups [18]. Conversely, in our study we were
279
able to show a significant reduction of both fluoroscopy times and radiation dose, mainly because
280
with IVUS, we managed to eliminate any additional angiography for endograft deployment, and to
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limit angiography taken as a whole to one final control.
282
In this continuing quest for a less invasive procedure, we must bear in mind that patients who are
283
candidates for EVAR currently undergo preoperative and postoperative CT scans in which the total 11
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contrast media amount may largely overwhelm the quantity of contrast media required for a
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standard, angiography assisted EVAR. Whatever the assisted technique applied, the advantage for
286
the patient is therefore quite limited, whereas it behooves a vascular surgeon to minimize the risk of
287
irradiation during his professional activities, and IVUS could be of pronounced interest in this
288
respect. A further advantage is that utilization use of the IVUS probe and imaging does not require
289
any specific or additional training for a typical vascular surgeon performing endovascular
290
procedures, even if he is not initiated to Duplex Ultrasound. Although not tested in this study, IVUS
291
assistance may be of interest in urgent cases, provided that a surgical team is thoroughly acquainted
292
with IVUS when the latter is routinely used for EVAR in asymptomatic patients. We have also
293
found that in urgent cases, the capacity to confirm access within the contralateral limb is yet another
294
potential advantage of IVUS. However, on the basis of this study it is not possible to know
295
determine whether or not use of IVUS could compensate in these emergencies for the absence of
296
preoperative CT angiography.
297
One final issue concerns the expenses incurred in IVUS-assisted procedures. The cost of the base
298
system and screen is around €60,000 ($66,600). Given that the expenses are often complementarily
299
defrayed by the industry (at least to high volume vascular services), the costs are actually limited to
300
those of the probe, which come to around €1500 ($1665) per procedure. Furthermore, an IVUS
301
probe can establish access to the contralateral gate with guidewire, thereby potentially avoiding the
302
supplementary costs of an additional catheter. To conclude, once IVUS performance is taken into
303
full account, its costs for both private and public institutions appear quite reasonable.
304
LIMITATIONS
305
While innovative, this preliminary study has some limitations: its retrospective nature, the lack of
306
randomization and the relatively small number of patients. Furthermore, in order to keep the studied
307
groups as homogeneous as possible, only patients with standard AAA were included. However, all
308
data were objectively recorded and assessed, with not a single patient lost to follow-up.
309 12
310
CONCLUSION
311
We have shown in this study that IVUS imaging for standard EVAR can be performed with
312
significantly reduced contrast media, shorter fluoroscopy times and reduced radiation dose
313
compared to angiography-assisted procedures, while achieving similar accuracy in endograft
314
positioning. Confirmation of our results by a large prospective study, comparing IVUS with
315
improved probes versus fusion imaging, is needed before IVUS-assisted EVAR can become
316
standard solo practice.
317 318
FIGURE LEGENDS
319
Figure 1. CONSORT flow chart of the study. AA, aortic aneurysm; IVUS, intravascular ultrasound.
320
Figure 2, Video 1. Pullback of the IVUS probe with location of the origin of the visceral arteries
321
during EVAR: celiac trunk (A), superior mesenteric artery (B), left renal vein (white arrow) and
322
renal arteries (red arrows) [C], common iliac artery bifurcation with the offspring of the hypogastric
323
artery (white arrow) [D].
324
Figure 3. The IVUS probe shows correct gaining of contralateral gate limb.
325 326
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15) McNally MM, Scali ST, Feezor RJ, Neal D, Huber TS, Beck AW. Three-dimensional fusion
366
computed tomography decreases radiation exposure, procedure time, and contrast use during
367
fenestrated endovascular aortic repair. J VascSurg 2015; 61:309-16
368
16) Schwein A, Chinnadurai P, Behler G, Lumsden AB, Bismuth J, Bechara CF.
369
Computed tomography angiography-fluoroscopy image fusion allows visceral vessel
370
cannulation without angiography during fenestrated endovascular aneurysm repair.
371
J Vasc Surg. 2018;68:2-11
372
17) Jones DW, Stangenberg L, Swerdlow NJ, Alef M, Lo R, Shuja F. Image fusion and 3-
373
dimensional roadmapping in endovascular surgery. Ann VascSurg 2018; 52:302-311
374
18) Maurel B, Martin-Gonzalez T, Chong D, Irwin A, Guimbretière G, Davis M, et al.
375
A prospective observational trial of fusion imaging in infrarenal aneurysms. J VascSurg 2018;
376
68: 1706-13
377
19) von Segesser LK, Marty B, Ruchat P, Bogen M, Gallino A. Routine use of intravascular
378
ultrasound for endovascular aneurysm repair: angiography is not necessary. Eur J
379
VascEndovascSurg 2002; 23:537-42
380 381 382
20) Pearce BJ, Jordan WD Jr.Using IVUS during EVAR and TEVAR: improving patient outcomes. SeminVascSurg 2009; 22:172-80 21) Hoshina K, Kato M, Miyahara T, Mikuriya A, Ohkubo N, Miyata T.A retrospective study of
383
intravascular ultrasound use in patients undergoing endovascular aneurysm repair: its
384
usefulness and a description of the procedure.Eur J VascEndovascSurg 2010;40:559-63
385
22) Kopp R, Zürn W, Weidenhagen R, Meimarakis G, Clevert DA. First experience using
386
intraoperative contrast-enhanced ultrasound during endovascular aneurysm repair for infrarenal
387
aortic aneurysms. J VascSurg 2010;51:1103-10 15
388
23) Albertini J, Kalliafas S, Travis S, Yusuf SW, Macierewicz JA, Whitaker SC, et al. Anatomical
389
risk factors for proximal perigraftendoleak and graft migration following endovascular repair of
390
abdominal aortic aneurysms. Eur J VascEndovasc Surg. 2000; 19:308–312
391
24) Lipsitz EC, Ohki T, Veith FJ, Berdejo G, Suggs WD, Wain RA, et al. Limited role for IVUS
392
in the endovascular repair of aortoiliac aneurysms. J CardiovascSurg (Torino) 2001; 42:787-92
393
25) White RA, Donayre C, Kopchok G, Walot I, Wilson E, de VirgilioC.Intravascular ultrasound:
394
the ultimate tool for abdominal aortic aneurysm assessment and endovascular graft delivery. J
395
EndovascSurg 1997;4: 45-55
396
26) Patel V, Lancaster RT, Mukhopadhyay S, Aranson NJ, Conrad MF, LaMuraglia GM, et al.
397
Impact of chronic kidney disease on outcomes after abdominal aortic aneurysm repair.
398
J VascSurg 2012;56:1206-13
399
27) Parfrey PS, Griffiths SM, Barrett BJ, Paul MD, Genge M, Withers J, et al. Contrast material-
400
induced renal failure in patients with diabetes mellitus, renal insufficiency, or both. A
401
prospective controlled study. N Engl J Med 1989; 320:143-9
402
28) Marty B, Tozzi P, Ruchat P, Haesler E, von Segesser LK. Systematic and exclusive use of
403
intravascular ultrasound for endovascular aneurysm repair - the Lausanne experience.
404
Interact CardiovascThoracSurg 2005; 4:275-9
405 406
29) Krasznai AG, Sigterman TA, BouwmanLH.Contrast Free Duplex-Assisted EVAR in Patients with Chronic Renal Insufficiency. Ann Vasc Dis 2014; 7:426-9
407
30) Gahlen J, Hansmann J, Schumacher H, Seelos R, Richter GM, Allenberget al. Carbon dioxide
408
angiography for endovascular grafting in high-risk patients with infrarenal abdominal aortic
409
aneurysms. J VascSurg 2001; 33:646-9.
16
TABLE 1. Anatomical features of infrarenal aortic aneurysms (n=173) Anatomy
P value
Group A
Group B
IVUS
Angiography
n=69
n=104
Mean neck length [mm]
20±2
21±3
.11
Mean conicity (α)*
9±1
8±2
.09
Calcification (1-10% neck circumference)
8±2
9±1
.09
154°±12°
160°±8°
.33
Iliac artery tortuosity (angle 140°- 170°)
* Calculation of the neck coefficient (α). Conical neck (α≥10), inverted conical neck (α≤−10), straight neck (−10<α<10). α, arctangent ([D2-D1]/L) ×180/π; D1, diameter at the level of the renal arteries; D2, diameter at the distal end of the neck; L, neck length. [23-24]
TABLE 2. Demography and risk factors. Group A
Group B
IVUS
Angiography
n=69
n=104
Age (years)
68
70
.90
Male Gender
82
80
.72
Hypertension
72
74
.88
Tobacco use (active)
60
62
.89
Dyslipidemia
30
36
.43
Diabetes
33
29
.63
Coronary artery disease
19
23
.59
Peripheral artery disease
17
18
.89
All data, except age are reported as percentage.
P value
TABLE 3. Primary Endpoints. Group A
Group B
IVUS
Angiography
n=69
N=104
Mean duration of fluoroscopy (min)
24±15
40±30
<.01
Contrast media administered (ml)
60±20
120±40
<.01
120±30
140±30
.07
99/97.8
98/97.6
.28
Mean duration of the procedure (minutes) Renal clearance before/after the procedure (ml/min)
P value
S0890-5096(19)30975-6
DOI:
https://doi.org/10.1016/j.avsg.2019.11.013
Reference:
AVSG 4776
To appear in:
Annals of Vascular Surgery
Received Date: 10 September 2019 Revised Date:
4 November 2019
Accepted Date: 5 November 2019
Please cite this article as: Illuminati G, Pacilè MA, Ceccanei G, Ruggeri M, La Torre G, Ricco JB, Peroperative Intravascular Ultrasound for Endovascular Aneurysm Repair vs. Peroperative Angiography: A pilot study in fit patients with favorable anatomy., Annals of Vascular Surgery (2019), doi: https:// doi.org/10.1016/j.avsg.2019.11.013. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. 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. © 2019 Published by Elsevier Inc.
1 2
Peroperative Intravascular Ultrasound for Endovascular Aneurysm Repair vs. Peroperative
3
Angiography: A pilot study in fit patients with favorable anatomy.
4 5
Giulio Illuminati*, Maria Antonietta Pacilè*, Gianluca Ceccanei*, Massimo Ruggeri*, Giuseppe La
6
Torre§, Jean-Baptiste Ricco†
7 8
* Department of Surgical Sciences, University of Rome “La Sapienza”, Rome, Italy
9
§ Department of Public Health and Epidemiology, University of Rome “La Sapienza”, Rome, Italy
10
† University of Poitiers, CHU de Poitiers, Department of Clinical Research, Poitiers, France
11 12
Presented at the 33rd Annual Meeting of the French Society for
13
Vascular and Endovascular Surgery, Nice, France, June 29 to July
14
2, 2018.
15 16
Correspondence:
17 18 19 20 21 22 23 24 25 26
Giulio Illuminati The Department of Surgical Sciences University of Rome “La Sapienza”, Rome, Italy Policlinico Umberto Primo Viale del Policlinico 00161 Rome, Italy E-mail: [email protected] Phone/Fax: + 39 06 49 97 06 42
27 28
Word count: 2917
29 30 1
31
ABSTRACT
32 33
Objectives
34
The aim of this study was to compare intravascular-ultrasound (IVUS) assistance for Endovascular
35
Aortic Aneurysm Repair (EVAR) to standard assistance by angiography.
36
Methods
37
From June 2015 to June 2017, 173 consecutive patients underwent EVAR. In this group, 69
38
procedures were IVUS-assisted with X-ray exposure limited to completion angiography for safety
39
purposes because IVUS probe does not yet incorporate a duplex probe (group A), and 104
40
angiography-assisted procedures (group B). All IVUS-assisted procedures were performed by
41
vascular surgeons with basic duplex ultrasound (DUS) training. The primary study endpoints were
42
mean radiation dose, duration of fluoroscopy, amount of contrast media administered, procedure-
43
related outcomes, and renal clearance expressed as the glomerular filtration rate (GFR) before and
44
after the procedure. Secondary endpoints were operative mortality, morbidity, and arterial access
45
complications.
46
Results
47
Mean duration of fluoroscopy time was significantly lower for IVUS-assisted procedures (24 ± 15
48
minutes vs. 40 ± 30 minutes for angiography-assisted procedures, p < .01). Moreover, mean
49
radiation dose (Air KERMA) was significantly lower in IVUS-assisted procedures [76m Gy (44–
50
102) vs. 131 mGy (58–494)], p <.01.IVUS-assisted procedures required fewer contrast media
51
compared to standard angiography-assisted procedures (60 ± 20 ml vs. 120 ± 40 ml, p < .01). Mean
52
duration of the procedure was comparable in the two groups (120 ± 30 minutes vs. 140 ± 30
53
minutes, p = 0.07). No difference in renal clearance before and after the procedure was observed in
54
either of the two groups (99.0 ± 4/ 97.8 ± 2 ml/min in group A and 98.0±3/97.6 ±5 ml/min in group
55
B (p = 0.28).Mean length of follow-up was 9 months [6–30 months]. No postoperative mortality,
56
morbidity or arterial access complications occurred. No type 1 endoleak was observed. Early type II 2
57
endoleaks were observed in 21 patients (11%), 12 in the angiography-assisted group (11%) and 9 in
58
the IVUS-assisted group (12%). They were not associated with sac enlargement ≥ 5 mm diameter
59
and therefore did not require any additional treatment.
60
Conclusions
61
Compared to standard angiography-assisted EVAR, IVUS significantly reduces renal load with
62
contrast media, fluoroscopy time and radiation dose, while preserving endograft deployment
63
efficiency. Confirmation from a large prospective study with improved IVUS
64
probes will be required before IVUS-assisted EVAR alone can become standard practice.
65 66 67
Key Words: Endovascular aortic repair, intravascular ultrasound, abdominal aortic aneurysm
68 69 70 71 72 73 74 75 76 77 78
3
79
INTRODUCTION
80
As endovascular aneurysm repair (EVAR) has become a standard method of treatment for
81
abdominal aortic aneurysm (AAA), potential kidney injury and allergy induction [1,2], the amount
82
of contrast media used during angiography-assisted procedures has arisen as an issue, as have the
83
risks related to X-ray exposure during fluoroscopy, for both patients and surgeons [3–8]. While
84
CO2-assisted angiography eliminates the risk of contrast media-induced nephropathy, it does not do
85
away with the risks related to fluoroscopy time [9–10].
86
Fusion imaging with road mapping seems to offer a promising alternative means of reducing
87
radiation exposure in both simple and complex endovascular aneurysm repair [11–16]. It has also
88
been applied in the settings of endoleak treatment and carotid stenting [17]. But up until now, even
89
though new cloud-based technology seems able to provide fusion imaging with overlapping on
90
mobile C-arms, fusion imaging is available only in expensive, hybrid suites [18].
91
Following recent technological advances, endovascular ultrasound (IVUS) has become highly
92
reliable in providing immediate intraoperative imaging of the aorta and its branches, including iliac
93
artery bifurcation. IVUS has also been shown to allow accurate assessment of proximal and distal
94
landing zones of an aortic endograft [19–22]. Compared to angiography-assisted procedures,
95
besides reducing the risk of contrast media-induced nephropathy, EVAR assisted by IVUS could
96
provide the further advantage of reducing fluoroscopy time and exposure to radiation, for the
97
patient and the surgeon, without lowering the accuracy of the procedure.
98
To confirm this hypothesis, we retrospectively reviewed our experience with EVAR, comparing
99
IVUS-assisted and standard angiography- assisted procedures.
100
MATERIAL AND METHODS
101
From June 2015 to June 2017, 173 consecutive patients, including 142 males of a mean age of 70
102
years [42 to 88 years] underwent EVAR at an academic tertiary care hospital and an affiliated
103
vascular surgery center. In this series, AAA included standard infrarenal aneurysms with the
104
exclusion of pararenal, or juxtarenal aneurysm amenable to the chimney technique. All the patients 4
105
gave written consent for both procedures (IVUS-assisted and standard angiography-assisted EVAR)
106
and their records were retrospectively reviewed for the purposes of the present study, for which,
107
given its retrospective nature, ethics committee approval was waived.
108
Concerning data protection, patients were identified in the case report form (CRF) by a code
109
composed of their initials, an assigned number, and the center number. This code was the only
110
information in the CRF enabling a retrospective link with a patient’s identity. Patient medical data
111
was provided only to the authors, and, when applicable and in strict confidence, to authorized health
112
authorities. Supervisory authorities could request direct access to medical records for the purposes
113
of verification of the procedures and/or data in respect of the study, within the limits authorized by
114
the relevant legislation and regulations. The data compiled during the study were processed in
115
compliance with all requirements of the EU data protection authority.
116
None of the patients included in this study presented renal insufficiency defined as serum creatinine
117
concentration > 120 mmol/dl and estimated glomerular filtration rate (GFR) < 90mL/min. Patients
118
with impaired renal function or renal insufficiency were systematically treated with IVUS-assisted
119
procedures and therefore excluded from the present study. Besides renal insufficiency, further
120
exclusion criteria included thoraco-abdominal, supra-and juxtarenal aneurysms. In order to avoid
121
any further bias, patients with angulated (> 60°), short (<1.5 cm), thrombus-lined or severely
122
calcified infrarenal aneurysm neck were likewise excluded (Table 1) [23–24]. In short, exclusion
123
criteria pertained to all patients with AAA not amenable to a standard endovascular treatment.
124
Patients in whom the indication for EVAR was rendered necessary due to severe comorbidities
125
contraindicating open surgical repair were also excluded. (Figure 1). As only patients with normal
126
renal function were included in the study, no special renal protection was applied in any of them.
127
According to imaging assistance, the patients were divided into 2 groups. In 69 patients (group A),
128
all procedures were IVUS-assisted, whereas in 104 patients (group B) all procedures were
129
angiography-assisted. The choice of imaging assistance was left to the surgeon’s preference, and all
5
130
IVUS- assisted procedures were performed by vascular surgeons who had received basic DUS
131
training and were supported by a tutor during the first 5 EVAR IVUS-assisted cases.
132
In this study, all patients in both groups underwent a final control angiography in order to identify
133
any type I endoleak. In group A, completion angiography was required due to the fact that the 0.35
134
IVUS probe, the only probe allowing complete imaging of the aorta and its branches, does not
135
incorporate a chromoflow Doppler probe. While smaller 0.14 and 0.18 catheter probes indeed
136
incorporate a chromoflow, their resolution is limited to coronary and lower limb arteries and
137
consequently not usable for the placement of an aortic endograft [R3, Q3]. In this study, two types
138
of C-arm were used, General Electric OEC 9800 Plus (General Electric OEC Medical Systems Inc.,
139
Salt Lake City, UT, USA) and General Electric Innova 4100 (General Electric Medical Systems
140
Inc., Salt Lake City, UT, USA). Measurement of absorbed radiation doses for both C-arms was
141
carried out with a Diamentor M4 – KDK detector (PTW, Freiburg, Germany) in order to eliminate
142
any possible error in dose measurement related to the type of C-arm.
143
Preoperative imaging consisted of a spiral angio-CT-scan with central lumen line to assess
144
aneurysm diameter, length of the aneurysmal neck and diameter of outflow arteries in view of
145
deciding on the optimal endovascular strategy and suitable endograft choice.
146
Arterial access was achieved through a femoral artery cutdown in 28 patients in group A and in 55
147
patients in group B and percutaneously in 46 patients in group A and in 59 patients in group B.
148
Percutaneous femoral access was closed with a single PercloseProGlide ® SMC device (Abbott
149
Vascular, Santa Clara, CA, USA) for sheaths of diameter not exceeding 11 Fr and with two devices
150
for sheaths of 12 to 21 Fr diameter.
151
For abdominal, IVUS- assisted procedures, after gaining femoral access and sheath introduction, the
152
IVUS probe (Volcano Vision ®PV 8.2 Fr) [Volcano Japan Inc., Tokyo, Japan] was advanced over a
153
Terumo standard guidewire (Terumo Corporation ®, Tokyo, Japan) or over a stiff guidewire above
154
the diaphragm and pulled back to locate the ostia of the celiac trunk, superior mesenteric artery, left
155
renal vein and renal arteries (Figure 2, Video 1). The position of the lower renal artery was marked 6
156
over the fluoroscopic monitor, and the probe was then pulled back again to identify the ostium of
157
the ipsilateral hypogastric artery. At this point, the reliability of IVUS – assessed data (diameter of
158
proximal and distal neck/landing zone, neck quality including eventual calcifications and thrombus)
159
with regard to those assessed by a CT scan was verified, and the main body of the endograft was
160
deployed. The IVUS probe was subsequently advanced through the contralateral femoral access to
161
reach the gate (Fig. 3) and assess the diameter and length of the contralateral limb of the graft and
162
the optimal landing zone. After complete deployment of the endograft, completion angiography was
163
systematically performed to verify the patency of renal and hypogastric arteries and to rule out the
164
presence of any type I endoleak. In all cases we were able to identify the main arterial landmarks
165
for endograft deployment with IVUS.
166
Within a month after discharge from the hospital, all of the patients underwent CT scan of the
167
thoracic and abdominal aorta followed by contrast-enhanced ultrasound every six months together
168
with CTscan of the abdominal aorta at 24 months. Mean length of follow-up was 9 months [6–30
169
months].
170
The primary endpoints of the study were mean duration of fluoroscopy and radiation dose, amount
171
of contrast media administered (mL), renal clearance expressed as the estimated GFR, before and
172
after the procedure, and incidence of primary type 1 endoleak. The radiation dose was expressed in
173
terms of KERMA (Kinetic Energy Released per unit of Matter), mGy. Secondary endpoints were
174
arterial access complications and type II endoleaks.
175
Risk factors
176
Hypertension was defined as any condition requiring antihypertensive drug(s), dyslipidemia as
177
serum triglyceride level > 150 mg/dL and/or cholesterol level >220 mg/dL, coronary artery disease
178
as clinical, electrical evidence of coronary artery disease or previous coronary artery
179
revascularization, and peripheral arterial disease as any clinical evidence of peripheral artery
180
obstructive disease or previous peripheral artery revascularization.
181 7
182
Statistical analysis
183
Frequency distributions were performed. All recorded data had a normal distribution, assessed by
184
the Kolmogorov–Smirnov test. Differences among the patients for the variables considered as
185
endpoints were assessed using the paired Student t-test. Differences between patients were tested
186
using the independent samples t-test. Differences for qualitative variables were assessed using the
187
chi-square test. Statistical analysis was carried out using the SPSS software for Windows,
188
release 25.0. Statistical significance was set at p value < .05.
189
RESULTS
190
Demography and risk factors were comparable in the two groups (Table 2). Overall, mean duration
191
of hospitalization was 3 days (range 2–6 days), including cutdown and percutaneous femoral
192
procedures over the duration of the study (5 years). For most recent patients, the length of
193
postoperative stay for uncomplicated percutaneous procedures in the series was 24 hours. Overall,
194
body mass index (BMI), differences which could affect measurement of radiation absorbed dose,
195
was comparable in the two groups: (group A, BMI: 27.01, [range, 21.1-34.8] vs. group B,
196
BMI: 26.6 [range, 20.4-34.0] (p = .73).
197
All in all, 173 patients underwent standard EVAR procedure forinfrarenal AAA (group A, n = 69;
198
group B, n= 104), in 6 patients, unilateral hypogastric artery embolization with external iliac artery
199
landing was required for an aneurysm involving the iliac artery bifurcation (group A, n = 4; group
200
B, n= 2). The endograft was a Gore Excluder endograft (WL Gore and ass., Flagstaff, AZ, USA) in
201
109 patients (n =47 in group A and n = 62 in group B) and a Bolton Treo endograft (Bolton
202
Medical®, Sunrise, FL, USA) in 64 patients (n=30 in group A and n=34 in group B). All
203
procedures were performed under local anesthesia and sedation. Twenty-two patients in group A
204
and 16 patients in group B were operated under dual antiplatelet treatment (100 mg oral
205
Aspirin/day + 75 mg oral Clopidogrel/day) due to recent (< 6 months) percutaneous coronary
206
angioplasty with drug-eluting stent implantation. The remaining patients underwent the procedure
8
207
under single antiplatelet treatment (100 mg oral Aspirin/day). All patients received statins (40 mg
208
oral atorvastatin/day) starting at least one week before the procedure.
209
Primary Endpoints
210
Mean duration of fluoroscopy was significantly lower in group A (24 ± 15 minutes) compared to
211
group B (40 ± 30 minutes, p < .01). Moreover, radiation dose was significantly lower in group A
212
compared to group B [76 mGy (44–102) vs. 131 mGy (58–494), p <.01]. Patients in group A
213
required significantly less contrast agent compared to those in group B (60 ± 20 ml vs. 120 ± 40 ml,
214
p < .01). Accuracy for endograft positioning with IVUS guidance was comparable to that obtained
215
with angiography guidance as shown on completion angiography. No type 1A or type 1B primary
216
endoleak occurred in this series due to precise location of the renal arteries and internal iliac arteries
217
following IVUS guidance.
218
The overall, mean duration of the procedure for aneurysm repair was comparable in groups A and B
219
(120 ± 30 minutes vs. 140 ± 30 minutes respectively, p = .07). No significant change of renal
220
clearance before and after the procedure (99.0 ± 4 and 97.8 ± 2 ml/min in group A and 98.0 ± 3 and
221
97.6 ± 5 ml/min in group B) was found in either group (p = .28) [Table 3].
222
Secondary Endpoints
223
No postoperative mortality, morbidity or arterial access complication was observed in either group.
224
No conversion to open surgery, aorto-mono-iliac endografting or significant modification of the
225
planned procedure was required.
226
Type II endoleaks were observed in 21 patients, 9 (12%) in group B and 12 (11%) in group A. None
227
of these endoleaks were followed by aneurysm sac enlargement ≥ 5 mm during follow-up and no
228
additional treatment was required. No late, type II endoleak was observed in either group.
229
DISCUSSION
230
The results of this study show that compared to standard angiography-assisted EVAR, IVUS-
231
assisted EVAR significantly reduces the load of contrast media and duration of fluoroscopy.
9
232
Compared to earlier probes [20], present-day IVUS probes are highly reliable, simple to manipulate
233
for any vascular surgeon with basic knowledge of DUS with a short learning curve of fewer than 5
234
cases. Due to technical evolution, initial problems and limitations of IVUS-assistance for EVAR
235
[20,22,24,25] can now be considered as resolved.
236
In agreement with results reported in previous studies [23, 25], IVUS was more efficient than
237
angiography in locating the ostia of the hypogastric arteries, without the problem of parallax in
238
antero-posterior view of angiography, which necessitates multiple projections.
239
Although not reducing operative time and blood loss compared to angiography, our study, in
240
agreement with others, [20–22] demonstrated that IVUS assistance provided significant reduction of
241
contrast media volume, which could certainly be beneficial for patients with renal failure, even
242
though neither the previous studies nor the present one have assessed its role in this respect. Given
243
that up to 30% of candidates for EVAR may present chronic renal failure [26] and given that
244
worsened renal function due to contrast agent injection may significantly prolong hospital stay and
245
increase the need for medications [27] IVUS-assisted procedures are of increasing interest.
246
Although post-procedure renal insufficiency has also been reported with IVUS-assisted EVAR [28],
247
it is very likely that this finding was more connected to renal artery embolism during catheterization
248
and proximal aortic neck maneuvering [21]. When dealing with a shaggy aorta, possible
249
displacement of thrombotic material from the aortic wall or aneurysmal sac with the IVUS probe
250
was one of our initial concerns when starting this technique. However, after the first cases, we
251
realized that there was little or no cause for concern. In our experience, IVUS was not associated
252
with any clinical distal embolism. On the contrary, the IVUS probe enabled us to obtain detailed
253
imaging of the intraluminal aortic thrombus, allowing careful introduction and navigation of
254
guidewires in patients with shaggy aorta. Some previous studies have proposed fully free contrast
255
media for IVUS-assisted EVAR, thereby avoiding completion angiography [19, 29] but running the
256
risk of missing a possible type I endoleak. We would not yet recommend this option. Missing a type
257
I endoleak would expose the patient to a high risk of aneurysm rupture. A possible alternative to 10
258
completion angiography could consist in the use of contrast-enhanced ultrasound for EVAR [28].
259
However, given the availability in the near future of a Doppler incorporated in the IVUS probe, the
260
need for completion angiography or contrast-enhanced ultrasound will be reduced, and contrast
261
media-free procedures may become standard.
262
Carbon dioxide (CO2) angiography has also been used for EVAR in patients with renal
263
insufficiency [9,10,30]. Its main advantage over IVUS is its sensitivity in detecting endoleaks due
264
to the low viscosity of CO2 media [22]. However, the quality of CO2 angiography imaging is
265
questionable, particularly in patients with severe artery calcifications with a need for long
266
fluoroscopy times to obtain satisfactory control imaging [9]. It should also be observed that
267
candidates for EVAR currently undergo preoperative and postoperative CT-scans in which the total
268
contrast media amount may largely overwhelm the quantity of contrast medium required for
269
standard, angiography-assisted EVAR. Nonetheless, a future study comparing IVUS-assisted to
270
CO2 angiography- assisted procedures and evaluating IVUS with CO2 angiography assistance
271
would be interesting as a means of validating the relative value of these imaging techniques.
272
According to a recent experiment, cloud 260-based technology fusion imaging, also available for
273
mobile C-arms, may compete with IVUS to significantly reduce radiation exposure during EVAR
274
[18]. However, in this study by Maurel et al. on 44 patients undergoing fusion-assisted EVAR
275
compared with 21 angiography-assisted controls, fusion imaging did not eliminate the need for
276
angiography, particularly prior to infrarenal endograft deployment, nor did it shorten total
277
fluoroscopy time. Moreover, no information was provided by the authors concerning the total
278
amount of contrast media administered in the two groups [18]. Conversely, in our study we were
279
able to show a significant reduction of both fluoroscopy times and radiation dose, mainly because
280
with IVUS, we managed to eliminate any additional angiography for endograft deployment, and to
281
limit angiography taken as a whole to one final control.
282
In this continuing quest for a less invasive procedure, we must bear in mind that patients who are
283
candidates for EVAR currently undergo preoperative and postoperative CT scans in which the total 11
284
contrast media amount may largely overwhelm the quantity of contrast media required for a
285
standard, angiography assisted EVAR. Whatever the assisted technique applied, the advantage for
286
the patient is therefore quite limited, whereas it behooves a vascular surgeon to minimize the risk of
287
irradiation during his professional activities, and IVUS could be of pronounced interest in this
288
respect. A further advantage is that utilization use of the IVUS probe and imaging does not require
289
any specific or additional training for a typical vascular surgeon performing endovascular
290
procedures, even if he is not initiated to Duplex Ultrasound. Although not tested in this study, IVUS
291
assistance may be of interest in urgent cases, provided that a surgical team is thoroughly acquainted
292
with IVUS when the latter is routinely used for EVAR in asymptomatic patients. We have also
293
found that in urgent cases, the capacity to confirm access within the contralateral limb is yet another
294
potential advantage of IVUS. However, on the basis of this study it is not possible to know
295
determine whether or not use of IVUS could compensate in these emergencies for the absence of
296
preoperative CT angiography.
297
One final issue concerns the expenses incurred in IVUS-assisted procedures. The cost of the base
298
system and screen is around €60,000 ($66,600). Given that the expenses are often complementarily
299
defrayed by the industry (at least to high volume vascular services), the costs are actually limited to
300
those of the probe, which come to around €1500 ($1665) per procedure. Furthermore, an IVUS
301
probe can establish access to the contralateral gate with guidewire, thereby potentially avoiding the
302
supplementary costs of an additional catheter. To conclude, once IVUS performance is taken into
303
full account, its costs for both private and public institutions appear quite reasonable.
304
LIMITATIONS
305
While innovative, this preliminary study has some limitations: its retrospective nature, the lack of
306
randomization and the relatively small number of patients. Furthermore, in order to keep the studied
307
groups as homogeneous as possible, only patients with standard AAA were included. However, all
308
data were objectively recorded and assessed, with not a single patient lost to follow-up.
309 12
310
CONCLUSION
311
We have shown in this study that IVUS imaging for standard EVAR can be performed with
312
significantly reduced contrast media, shorter fluoroscopy times and reduced radiation dose
313
compared to angiography-assisted procedures, while achieving similar accuracy in endograft
314
positioning. Confirmation of our results by a large prospective study, comparing IVUS with
315
improved probes versus fusion imaging, is needed before IVUS-assisted EVAR can become
316
standard solo practice.
317 318
FIGURE LEGENDS
319
Figure 1. CONSORT flow chart of the study. AA, aortic aneurysm; IVUS, intravascular ultrasound.
320
Figure 2, Video 1. Pullback of the IVUS probe with location of the origin of the visceral arteries
321
during EVAR: celiac trunk (A), superior mesenteric artery (B), left renal vein (white arrow) and
322
renal arteries (red arrows) [C], common iliac artery bifurcation with the offspring of the hypogastric
323
artery (white arrow) [D].
324
Figure 3. The IVUS probe shows correct gaining of contralateral gate limb.
325 326
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16
TABLE 1. Anatomical features of infrarenal aortic aneurysms (n=173) Anatomy
P value
Group A
Group B
IVUS
Angiography
n=69
n=104
Mean neck length [mm]
20±2
21±3
.11
Mean conicity (α)*
9±1
8±2
.09
Calcification (1-10% neck circumference)
8±2
9±1
.09
154°±12°
160°±8°
.33
Iliac artery tortuosity (angle 140°- 170°)
* Calculation of the neck coefficient (α). Conical neck (α≥10), inverted conical neck (α≤−10), straight neck (−10<α<10). α, arctangent ([D2-D1]/L) ×180/π; D1, diameter at the level of the renal arteries; D2, diameter at the distal end of the neck; L, neck length. [23-24]
TABLE 2. Demography and risk factors. Group A
Group B
IVUS
Angiography
n=69
n=104
Age (years)
68
70
.90
Male Gender
82
80
.72
Hypertension
72
74
.88
Tobacco use (active)
60
62
.89
Dyslipidemia
30
36
.43
Diabetes
33
29
.63
Coronary artery disease
19
23
.59
Peripheral artery disease
17
18
.89
All data, except age are reported as percentage.
P value
TABLE 3. Primary Endpoints. Group A
Group B
IVUS
Angiography
n=69
N=104
Mean duration of fluoroscopy (min)
24±15
40±30
<.01
Contrast media administered (ml)
60±20
120±40
<.01
120±30
140±30
.07
99/97.8
98/97.6
.28
Mean duration of the procedure (minutes) Renal clearance before/after the procedure (ml/min)
P value