Mellouk Aid et al.

Systematic Reviews (2017) 6:89

DOI 10.1186/s13643-017-0474-y

PROTOCOL Open Access

MOrtality and infectious complications of

therapeutic EndoVAscular interventional
radiology: a systematic and meta-analysis
protocol
Kaoutar Mellouk Aid1,2*, Hervé Tchala Vignon Zomahoun3, Abdelmajid Soulaymani1, Karin Lebascle4,
Stephane Silvera5, Pascal Astagneau6 and Benoit Misset7,8,9,10

Abstract
Background: Endovascular interventional radiology (EIR) is an increasingly popular, mini invasive treatment option
for patient with symptomatic vascular disease. The EIR practiced by qualified hands is an effective, well-tolerated
procedure that offers relief of patient’s symptoms with a low risk of complications. During acute post procedural
period, immediate complications may relate to vascular access, restenosis, thromboembolic events, uterine
ischemia, infection, necrosis, sepsis, ICU stay, surgical recovery, pain management, treatment failure, and death.
Moreover, additional non-life-threatening complications exist, but they are not well described and represent
disparate information.
Methods/design: A range of databases will be screened consulted to identify the relevant studies: PubMed,
EMBASE, The Cochrane Library, NosoBase, and Google Scholar (to identify articles not yet indexed). Scientist
librarian used Medical Subject Headings (MeSH) and free terms to construct the search strategy in PubMed. This
search strategy will be adapted in other databases. Two coauthors will independently select the relevant studies,
extract the relevant data, and assess the risk of bias in the included studies. Any disagreements between the two
authors will be solved by a third author.
Discussion: This systematic review will provide a synthesis of EIR complications. The spotlighted results will be
analyzed in order to provide a state-of-knowledge synopsis of the current evidence base in relation to the
epidemiology of the infectious complications after EIR. In the event of conclusive results, our findings will serve as a
reference background to assess guidelines on reality of the problem of the infections linked to endovascular
interventional radiology and to formulate of assumptions and propose preventive measures, based on the results of
our investigations. These propositions will aim to reduce the risk and/or the severity of these complications in the
concerned population in favor a positive medical economics report. It will also aim to decrease the antibio-
resistance and in fine will improve health status and security of patients.
Systematic review registration: PROSPERO CRD42015025594
Keywords: Endovascular interventional radiology, Risk of complications, Infectious complications, Epidemiology,
Mortality, Systematic review, Meta-analysis

* Correspondence: kaoutarmellouk92@gmail.com
1
Laboratory of Genetics and Biometrics, Faculty of Sciences, Ibn Tofail
University, Kenitra, Morocco
2
Clinical Research Centre, Foundation Hospital Saint-Joseph, 185 Rue
Raymond Losserand, 75014 Paris, France
Full list of author information is available at the end of the article

© The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Mellouk Aid et al. Systematic Reviews (2017) 6:89 Page 2 of 8

Introduction Bacteremia was observed in 35% of patients; including

Interventional radiology is a clinical discipline with a 13% of clinical infection, after completion of a trans-
procedural foundation rooted in diagnostic imaging and jugular intrahepatic porto-systemic shunts (TIPS) [15].
almost entirely innovation dependent. Interventional ra- In endovascular interventional radiology, which ex-
diologists possess a special blend of knowledge based on empts of vascular catheterization techniques, the num-
a fundamental diagnostic imaging complemented by ber of infections varies also according to the procedure.
technical and clinical management expertise when ap- Regarding guided percutaneous liver puncture, available
plied skillfully and with care, can save and improve lives figures vary from 0 to 0.3%, depending on the thera-
cost-effectively [1]. peutic actions of tumor destruction (radio-frequency)
Since the first interventional radiology held on January [16, 17].
16, 1964, on dilation of the stenosis with a guide wire In the endo-cavitary interventional radiology echo-
and coaxial Teflon catheters, a catheter-based therapies, guided, four observations of Pseudomonas aeruginosa in-
featuring low-risk expectation, low cost, and excellent fections have been reported after trans-rectal biopsy
outcomes [2, 3]. Currently, the interventional radiology echo-geared [18]; the rate of infectious complications is
involves biopsy of deep internal organs, drain abscesses between 3 and 10% [19].
and cysts, and open blocked arteries and veins with de- For percutaneous gastrostomies, the risk of local infec-
vices or medications. It does provide a way obstructed tion would be higher with a radiological approach than an
kidneys and biliary tracts might be emptied. Rather than endoscopic approach (7.3 vs 1.%); however, antibiotic
an area of screening, interventional radiology is usually prophylaxis practices have different outcomes [20].
used for patients end up for therapeutic procedures, Some patients show up with a history of previous reac-
often after several other diagnostic studies [4]. The tion to contrast agents. Contrast products are associated
advantages of interventional radiology include [5, 6] (i) with a very low incidence of adverse reactions. According
the ability to perform most procedures in an outpatient to Hunt et al., from 2002 to 2006, a global retrospective
setting, (ii) general anesthesia is usually not required, review of adverse effects of administration of low-osmolar
(iii) risk, pain, and recovery time are often significantly iodinated and gadolinium contrast agents, a total of
reduced, and the procedures are sometimes less expen- 456,930 contrast doses were administered. A merely 522
sive than surgery. adverse effects were identified (0.114% of all doses). One
Among these procedures, evaluation of cardiac status death occurred 30 min after agent injection [21].
and coronary catheter arterial and selective angiography Complications related to interventional radiology are a
took a growing place in the assessment of prognosis of part of the new subsisting public health problems. To our
cardiovascular diseases. The angioplasty coronary revas- knowledge, no meta-analysis was conducted on this sub-
cularization method became the most used in the world ject. Referring to the national French surveillance system
[6]. Although the long-term durability of many of these for control of nosocomial infections, very few notifications
interventional procedures remains to be established, it is of infectious complications have been reported for the last
estimated that in the near future, 40 to 70% of vascular 10 years. Hence, we decided to perform a systematic re-
interventions will be endovascular procedure [7]. As IR view and meta-analysis to determine the state of the art
has been shown to be generally more cost-effective than on morbidity related to IR complications.
alternative surgical treatments, there has been a tremen-
dous increase in the number of IR procedures performed
worldwide [8]. Due to the rapidly broadening spectrum Objective
of interventional percutaneous procedures, the trans- This study aims to assess the associations between the
femoral access route is expected to remain a cornerstone endovascular interventional radiology and the infectious
of catheter-based diagnosis and treatment and valid al- complications in children and adults.
ternative to the trans-radial access [9, 10]. However,
complications of the vascular access site are still challen-
ging representing the leading cause of morbidity associ- Methods/design
ated with trans-femoral catheterization [11, 12]. In the present protocol, we designed a systematic re-
Medical errors may occur in any medical field despite view and meta-analysis using the Cochrane Handbook
the safety of the procedure. In endovascular interventional recommendations [22]. This protocol was registered
radiology, a number of studies assessing the risk of adverse (CRD42015025594) in the Prospective Register of Sys-
events to 0.06% for percutaneous catheterization, 0.64% tematic Reviews (PROSPERO) conforming the guide-
for coronary angioplasty, and 4.9% for all arterial and lines of Preferred Reporting Items for Systematic
venous angioplasty [11, 13]. A 2.6% of hepatic abscess review and Meta-Analysis Protocols (see PRISMA-P
rates have been reported after chemoembolization [14]. checklist, Additional file 1) [23].
Mellouk Aid et al. Systematic Reviews (2017) 6:89 Page 3 of 8

Eligibility criteria Exclusion criteria

Participant/population Articles that meet the following criteria will not be in-
This review will consider all studies conducted among cluded in the review:
children or adults. There will be no limitation on gender
or health status (Additional file 2). 1. Literature reviews. However, the list of bibliographic
references of relevant reviews will be screened to
Type of exposure identify additional relevant studies.
The exposure that will be assessed is aortic endovascular 2. Non-human study
interventional radiology procedures for therapeutic pur- 3. Case reports or studies with less than three cases for
pose: angioplasty, therapeutic angiography, endoprosthesis, each group
insertion of shunts and stents, embolization and thrombec- 4. Scientific correspondence
tomy, and aortic aneurysm therapy. 5. Exposure related to chemoembolization
6. Exposure related to radiological techniques of
Comparators diagnosis
People who were not exposed to aortic endovascular 7. Exposure related to surgical treatment only
interventional radiology will be considered for compara- 8. Exposure related to radiological technique in a non-
tor groups. vascular territory (e.g, biliary tract, gastrointestinal
tract, and bronchi)
Type of outcomes 9. Exposure related to secondary infection indirectly
An infection is nosocomial if it appears during or follow- related to the arterial act (e.g, lung infection by
ing a hospitalization and if it was absent at admission at inhalation and infection related to a digestive
hospital [24]. For the infections of operational site and ischemia
interventional radiology, one regards infection bound 10.Exposure related to absence of complications
that occurred in the 30 days following the intervention, 11.Exposure related to central catheters with
or, if there were installation of prosthesis, stent, or an implantable chambers or not
implant, for the year which follows the intervention. 12.Any infections preceding radiological act
Secondary outcomes: the rate of technical failure, mech-
anical complications, length of hospitalization in intensive Search strategy
care unit, inefficiency of endovascular therapeutic inter- The search strategy will be designed to access both pub-
ventions, surgical replacement therapy, and, finally, death lished and unpublished studies. To identify published stud-
frequency. ies, we will perform a systematic literature search using
Only studies which feedback relative information electronic databases: PubMed, EMBASE, The Cochrane Li-
about all post radiological infectious interventions will brary, NosoBase, and Google Scholar. Our scientist librar-
be included in this review. All infections (bacterial and ian built a preliminary literature search strategy in PubMed
fungus infections) will be considered. Studies in which using keywords related to exposition and main outcome
procedures for diagnosis only reported will be excluded. (Additional file 2). The search terms will be adapted for the
different databases using a combination of Medical Subject
Timing Heading (MeSH), free terms, and relevant keywords.
We will consider only studies in which the nosocomial The equation of search was based on the following
infection was diagnosed after a radiological act. logic: Elements appropriate to the aortic endovascular
interventional radiology «AND» Elements appropriate to
Types of studies infectious complications.
The review will consider all experimental (randomized Additional studies will be sought in the bibliographic
controlled trials) and observational studies (prospective reference lists of studies selected from electronic data-
and retrospective cohort studies). bases and those of relevant systematic reviews. To identify
unpublished studies, we will search through gray literature
Language including reports and conference abstract books, accord-
We will consider articles published in French and ing to diagramme of "Search strategy, description of data"
English language. (Additional file 3). We will also search ongoing trials in
ClinicalTrials.gov and controlled-trials.com. Furthermore,
Period the following data sources will be consulted:
There will be no restriction regarding publication date
of studies. We will consider for screening all published  Society of Interventional Radiology
studies until literature search date in different databases.  Society of Pediatric Interventional Radiology
Mellouk Aid et al. Systematic Reviews (2017) 6:89 Page 4 of 8

 Western Angiographic & Interventional Society level, socio-economic level, and other existing
 The Interventional Initiative diseases)
 The Endovascular Forum  EIR history
 Interventional radiology procedures b Characteristics of intervention
 EIR urgently performed or not
Study selection process  EIR technique used
Two independent reviewers (K. Mellouk and B. Misset)  Description of EIR procedure-type of endovascu-
will initially screen primary titles and abstracts to select lar site of intervention
potential full text articles for further scrutiny. When the  Type of catheter used
title and abstract is not rejected by any reviewer, the full  Method used to sterilize the intervention
text of the article will be obtained and will carefully as- equipment
sess for inclusion by the two reviewers (KM and BM).  Reasons of EIR
For this step, we will adopt the selection form includ-  Duration of EIR
ing the selection criteria (Additional file 4). We will pilot  Observation time post EIR
this form to ensure that the criteria are clear for the  Number of monitoring visits after EIR
both reviewers. The pilot test of the selection criteria  Intervention team profile (e.g., healthcare
will be made on 10% of total unique references. The se- assistant, nurse, technologist, physician, and/or
lection form would be amended/updated depending on radiologist)
the pilot test results.  Interventionist’s profile (e.g., sex, age, time since
graduation, and experience in EIR)
Data collection process c Characteristics of outcomes
We will create an extraction data form and a codebook  Nosocomial infection (infectious agent name,
in which the relevant variables will be described (defin- site, type, and diagnostic test used)
ition and modalities). A pilot of the data extraction form  Other complications
will be undertaken by two reviewers using a random  Technical failure
sample representing 10% of included articles. The data  Mechanical complications
extraction form and the codebook will be amended/up-  Hospitalization in intensive care unit (ICU)
dated as necessary.  Inefficiency of endovascular therapeutic
One author (KM) will extract data from all the in- interventions
cluded papers and another coauthor (BM) will verify the  Hospitalization for second time
accuracy of this extraction. Any disagreement will be  Surgical recovery
solved through discussion. If no agreement is reached, a  Death
third author (PA) will be consulted. Disagreements be- d Effect of endovascular interventional radiology on
tween KM, BM, and PA will be resolved by consensus, outcomes
according to diagramme of "Step of selection of the arti- Dichotomous outcomes
cles/screening" (Additional file 5).  Definition and measurement of outcome
The following pre-specified variables will be extracted  Number of events and sample size in each
from selected studies: group
 Non-events and sample size in each group
a Characteristic of studies and participants  Events and non-events in each group
 First author’s name  Event rate and sample size in each group
 Country, city, and hospital where patients  Odds ratio (OR), risk ratio (RR), or hazard
recruited ratio (HR), 95% confidence interval (CI), and p
 Year of publication value
 Year of patient recruitment (the midpoint of the Continuous outcomes
study’s time period)  Definition and measurement of outcome
 Study design  Mean, standard deviation (SD), and sample
 Type of participants’ sample (e.g., consecutive size in each group
and random)  Difference of means, 95% CI, and p value
 Sample size
 Rate of participation Assessment of risk of bias in individual studies
 Study setting The goal of this assessment is to make a methodological
 Socio-demographic characteristics of judgment of whether the design and implementation of
participants (age, sex, race/ethnicity, education the study compromised the internal validity of the
Mellouk Aid et al. Systematic Reviews (2017) 6:89 Page 5 of 8

association between exposure (therapeutic endovascular cumulative evidence with the Grading of Recommenda-
interventional radiology) and the outcome (infectious tions Assessment, Development and Evaluation (GRADE)
complications or other clinical outcomes). The presence [29]. This tool is based on five criteria such as individual
of potential bias within individual studies will be study risk of bias, indirectness of the evidence, data het-
assessed independently by the two authors (KM and erogeneity, imprecision of the effect size estimates, and
BM) using the Cochrane’s “risk of bias” assessment tool risk of publication bias. For each outcome, the quality of
for randomized controlled trials [23] and the Newcastle- evidence will be rated high, moderate, low, or very low.
Ottawa Scale for observational studies [25].
Only studies of good and average quality will be Discussion
retained for statistical analysis. Therapeutic endovascular interventional radiology through
a percutaneous route is increasing rapidly in volume, and
Data synthesis and analysis their potential adverse effect may rise accordingly.
Only studies, in which data on endovascular interven- This protocol will allow to perform a systematic review
tional radiology and outcomes will be available to estimate of the epidemiology of these events. This will serve as
the effect size, will be included in the meta-analysis. When the rational for designing future epidemiological and
effect sizes will not be calculable or when only one effect interventional studies.
size available for an outcome, we will report the results of Interventional or therapeutic radiology is now a discip-
this outcome as a narrative synthesis. If effect sizes will be line that achieves a complete support from patients. This
available or calculable in two or more studies for a specific efficient multidisciplinarily gains confirmation and
outcome, meta-analysis will be conducted using the soft- strength from health technical developments leading to
ware Review Manager (RevMan). We will use, as effect new frontiers between exploration (imaging, biology,
sizes, the RR with 95% CI for dichotomous outcomes and and functional) and treatment techniques (interventional
standardized mean difference (SMD) with 95% CI for con- imaging, endoscopy, surgery, therapy by physical agents,
tinuous outcomes. Since we anticipate a potential hetero- and the evolutions of the patients demand, for a sup-
geneity in studies, we will use a random-effects model to ported rapid, effective, and less invasive technique [30].
pool effect sizes of endovascular interventional radiology The patient’s condition sent in IR is extremely variable
for each outcome [26]. Only the adjusted effect size will depending on their department of original (intensive
be considered in this model. We will also calculate care, for example), their age, subjacent pathologies, the
Higgins’ I2 statistic that is the percentage of variability in evolving affection condition, the existence of factors pro-
the effect size estimates due to the heterogeneity [27]. The moting the infection, their immune status, the presence
chi-squared test will be used to test the heterogeneity [28]. of invasive devices (catheters and probes), skin lesions,
Moreover, the potential heterogeneity will be explored the presence or not of infection, or known portage or
using subgroup analyses based on studies, participants, not of microorganisms such as multiresistant ones to an-
and intervention characteristics mentioned above. tibiotics (BMR bacteria epidemic-prone (such as MRSA
We will also assess the publication bias for each out- and ESBL enterobacteria) and bacteria highly resistant to
come by visually examining funnel plots when more antibiotics (BHR, such as GRE and CPE). In addition, IR
than ten studies will be included in the meta-analysis. procedure usually performed in a hospital setting in-
To assess the robustness of our results, we plan to per- creases the risk of exposure to blood and biological
form a few sensitivity analyses. First, we will explore the fluids for the professional staff [31].
individual influence of each study by removing one at The acts charged are extremely varied, with very differ-
the time from the pooled effect size estimation. Second, ent risks. Group SFR - IRF (French society of Radiology -
we will repeat the pooled effect size estimation for each Interventional Radiology Federation) has established a list
outcome by including only studies with low risk of bias. of acts of IR, classifying them into three categories, de-
Finally, we anticipate that confounding variables could pending on the level of complexity, including potential
vary according to studies. risks, particularly, the risk infectious [32]. For each cat-
Thus, we will estimate the pooled crude effect size for egory, a number of precautions are required, the level of
each outcome using crude effect sizes (non-adjusted) infectious risk determining the level of precautions to be
only. Results of these analyses will be compared with ini- taken [32].
tial pooled effect size in order to assess the confounding Control of the risk of infection in IR is thus based on
variables’ impact. the strict observance of standard hygiene precautions
and the existence of procedures defined, applied and
Confidence in cumulative evidence evaluated, maintenance of the various equipment, in par-
In order to reduce the misinterpretation of our review’s ticular, those used for guidance, in an integrated envir-
results, we will assess, for each outcome, the quality of onment [33, 34].
Mellouk Aid et al. Systematic Reviews (2017) 6:89 Page 6 of 8

Although there are no controlled trials to establish for- Additional file 3: Search strategy, description of data. (DOC 25 kb)
mal evidence of an advantage of prophylactic antibiotics Additional file 4: Decisional diagram of selection of an article starting
in IR, it should be considered in certain situations [35– from the title and summary. (DOC 53 kb)
37]. Its use must be weighed against the potential risks Additional file 5: Step of selection of the articles/screening. (DOC 27 kb)
of misuse (germ resistant and hypersensitivity selection)
and was decided in a multidisciplinary way [38]. It Abbreviations
should be the subject of a service protocol, referring to BHR: Bacteria highly resistant; BMR: Bacteria Multi-Resistance; CI: Confidence
interval; CPE: Carbapenemase-producing enterobacteria; EIR: Endovascular
the consensus conference of the French Anesthesia and
interventional radiology; ESBL: Extended-spectrum beta-lactamases secreting
Reanimation Society (SFAR), who, under the aegis of the enterobacteria; GRE: Glycopeptide-resistant enterococci; HAS: French National
French National Authority for Health (HAS) and in col- Authority for Health; HR: Hazard ratio; ICU: Intensive care unit;
IRF: Interventional Radiology Federation; MRSA: Methicillin-resistant
laboration with the concerned societies and in particular
Staphylococcus aureus; OR: Odds ratio; RR: Risk ratio; SD: Standard deviation;
the IRF, proceeded, in 2010, the update of the periopera- SFAR: French Anesthesia and Reanimation Society; SFR: French Society of
tive recommendations in surgery and interventional Radiology; SMD: Standardized mean difference; TIPS: Trans-jugular
intrahepatic porto-systemic shunts IR
radiology [39]. Prophylaxis antibiotic therapy is recom-
mended for endoscopic gastrostomies, sclerosis of vari- Acknowledgements
cose veins of the esophagus, stents, and stents (except We thank Pr. Abousaleh Youssef for his helpful comments and participation
intra-coronal); it should be also considered in some sub- to English editing.
jects at risk [40].
Funding
The risk of other complications over the procedure of This work was performed in the framework of the first author’s doctorate
the IR according to some studies is linked to a volume ef- project.
fect (the relationship between the volume of activity and
the therapeutic risk incurred). Many studies have evalu- Availability of data and materials
Not applicable
ated the relationship between coronary angioplasty activity
level and the risk of serious complications (death of the Authors’ contributions
patient and need for bypass in emergency of myocardial KMA, HTVZ, PA, and BM contributed to the study concept and design. KMA,
KL, HTVZ, and AS developed the methods of the review including the search
infarction) due to therapeutic procedures [41]. These pub- strategy. All the authors were involved in the critical revision of the
lications show that the risk for a patient is inversely pro- manuscript for important intellectual content. All authors read and approved
portional to the level of activity of the center in which it is the final manuscript.
processed [6].
Authors’ information
The physician experience performing angioplasty has a For further information please contact Kaoutar Mellouk;
similar impact; especially when a large majority of pa- kaoutarmellouk92@gmail.com
tients with complex lesions are treated with this tech-
nique of revascularization [42–45]. After adjusting for Competing interests
The authors declare that they have no competing interests.
other risk factors, this study highlights a strong correl-
ation between the number of patients treated annually Consent for publication
by angioplasticien and the reduction of risk of serious Not applicable
cumulative complications (myocardial infarction, aorta-
Ethics approval and consent to participate
coronary bypass in emergencies, and death). Ethics approval is not required because our study is a systematic review and
The angioplasticiens dealing with less than 70 patients meta-analysis.
per year have an overall rate of serious complications of
9.3%. While the angioplasticiens operating more than Publisher’s Note
270 patients per year, the rates are respectively 2.9 and Springer Nature remains neutral with regard to jurisdictional claims in
1.7% (p < 0.001). The risk of angioplasty decreased up to published maps and institutional affiliations.
a threshold between 225 and 270 annual angioplasties Author details
by doctor [46]. Beyond that, the rate of complications 1
Laboratory of Genetics and Biometrics, Faculty of Sciences, Ibn Tofail
reached a remarkably low level, despite the more serious University, Kenitra, Morocco. 2Clinical Research Centre, Foundation Hospital
Saint-Joseph, 185 Rue Raymond Losserand, 75014 Paris, France. 3Québec
patient’s support [47]. SPOR-SUPPORT Unit Research Centre of CHU de Québec, Université Laval,
Québec City, Québec, Canada. 4Centre for Control of Healthcare-Associated
Infections, Paris, France. 5Foundation Hospital Saint-Joseph, 185 Rue
Raymond Losserand, 75014 Paris, France. 6Centre for Control of
Additional files Healthcare-Associated Infections and Pierre & Marie Curie Faculty of
Medicine, Sorbonne Universities, Paris, France. 7Department of Intensive Care
Additional file 1: PRISMA-P file, PRISMA-P 2015 Checklist. (DOCX 38 kb) and Clinical Research Centre, Foundation Hospital Saint-Joseph, 185 Rue
Raymond Losserand, 75014 Paris, France. 8Paris Descartes University, Paris,
Additional file 2: Population, intervention, comparator, outcomes, study
design, and time breakdown of study eligibility criteria. (DOC 31 kb) France. 9Department of Intensive Care, Rouen, France. 10Rouen University
Hospital, University of Rouen, Rouen, France.
Mellouk Aid et al. Systematic Reviews (2017) 6:89 Page 7 of 8

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