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Meta-analysis
Corticosteroid Therapy and Vascular Complications in Patients Undergoing
Transcatheter Aortic Valve Replacement: A Meta-analysis With
Meta-regression
Francis Yuri Macedo, MD, MSc
a
,
*
, Tilak Pasala, MD, MRCP
a
, Ryan Kaple, MD
a
, Rodrigo Lago, MD
b
,
Pedro Villablanca, MD, MSc
c
, Carolina Mejia-Otero, MD
d
, Jefferson Vieira, MD, PhD
e
,
Basel Ramlawi, MD
f
,
g
, Michel Pompeu S
a, MD, MSc, PhD
f
,
g
a
Division of Structural Heart Disease, Department of Medicine, Hackensack University Medical Center, Hackensack, New Jersey;
b
Division of Cardiology, Department of
Medicine, AdventHealth, Orlando, Florida;
c
Department of Medicine, Center for Structural Heart Disease, Henry Ford Hospital, Detroit, Michigan;
d
Division of
Rheumatology, Department of Medicine, College of Medicine, Florida State University, Tallahassee, Florida;
e
Division of Advanced Heart Failure and Transplant,
Messejana Hospital, Fortaleza, Ceara, Brazil;
f
Department of Cardiothoracic Surgery, Lankenau Heart Institute, Lankenau Medical Center, Main Line Health, Wynnewood,
Pennsylvania;
g
Department of Cardiothoracic Surgery Research, Lankenau Institute for Medical Research, Wynnewood, Pennsylvania
ABSTRACT
Background: Corticosteroid use is associated with vascular fragility, prolonged wound healing, and infections. Therefore, we sought to compare outcomes between
patients with aortic stenosis undergoing transcatheter aortic valve replacement who were using corticosteroids versus those who were not.
Methods: This is a study-level meta-analysis and meta-regression of observational studies. The primary end points of this study were rates of vascular complication
(both major and minor), life-threatening bleeding, and 30-day mortality. Secondary end points included acute kidney injury rates, annular rupture, cardiac tampo-
nade, closure device failure, coronary obstruction, periprocedural myocardial infarction, permanent pacemaker implantation, stroke, and specific vascular compli-
cations with its complementary therapy.
Results: Across the studies, patients were slightly predominantly female, older, and had a mean left ventricular ejection fraction of more than 50% with an inter-
mediate Logistic EuroScore II. Significant differences were observed in the vascular complication rates between patients on corticosteroids and those who were
corticosteroid-free (relative risk, 0.63; 95% CI, 0.35-0.90; P<.001), driven primarily by arterial occlusion, surgery, balloon angioplasty, and stenting (relative risk,
0.63; 95% CI, 0.32-0.93; P<.05). There was no difference in the 30-day mortality. No differences were seen in the length of corticosteroid therapies. For the secondary
outcomes, there was an increased risk of annular rupture and cardiac tamponade in patients taking corticosteroids.
Conclusions: In conclusion, this is the first meta-analysis with meta-regression that showed a higher risk for vascular complications and life-threatening bleeding in
patients on corticosteroid therapy undergoing transcatheter aortic valve replacement, despite no increase in the risk of 30-day mortality.
Based on the positive results of the PARTNER 3
1
and the Evolut Low
Risk
2
trials, in 2019, the US Food and Drug Administration approved
transcatheter aortic valve replacement (TAVR) for the treatment of se-
vere aortic stenosis in low-risk patients, expanding its indication previ-
ously approved for patients with intermediate, high, and prohibitive
risks. As a result, more patients with aortic stenosis are expected to un-
dergo TAVR, including those with chronic conditions treated with ste-
roids.
3
Regular steroid use is a well-known factor for tissue fragility,
which can become an issue when dealing with large-bore vascular access
for TAVR.
4
Patients treated with steroids have an increased risk of early
death after cardiac surgery.
5
Therefore, the Society of Thoracic Surgeons
score considers steroids when estimating the 30-day mortality after any
cardiac surgical procedure.
6
Transcatheter aortic valve replacement may be advantageous in
preventing wound complications and life-threatening infections, thereby
minimizing the risk of undesired events, compared with surgical aortic
valve replacement in patients on chronic steroid therapy.
7
However, only
a few studies have assessed corticosteroids in patients undergoing TAVR,
Abbreviations: AKI, acute kidney injury; MI, myocardial infarction; PPI, permanent pacemaker implantation; RR, relative risk; TAVR, transcatheter aortic valve
replacement.
Keywords: corticosteroids; heart valve prosthesis implantation; meta-analysis; mortality; transcatheter aortic valve replacement; vascular complications.
* Corresponding author: fmaccedo@gmail.com (F.Y. Macedo).
Contents lists available at ScienceDirect
Journal of the Society for Cardiovascular
Angiography & Interventions
journal homepage: www.jscai.org
https://doi.org/10.1016/j.jscai.2022.100446
Received 16 June 2022; Received in revised form 27 July 2022; Accepted 9 August 2022
Available online xxxx
2772-9303/©2022 The Author(s). Published by Elsevier Inc. on behalf of the Society for Cardiovascular Angiography and Interventions Foundation. This is an open
access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Journal of the Society for Cardiovascular Angiography & Interventions xxx (xxxx) xxx
Please cite this article as: Macedo, FY et al., Corticosteroid Therapy and Vascular Complications in Patients Undergoing Transcatheter Aortic Valve
Replacement: A Meta-analysis With Meta-regression, Journal of the Society for Cardiovascular Angiography & Interventions, https://doi.org/
10.1016/j.jscai.2022.100446
and the link between corticosteroid use and vascular complications re-
mains unclear. No randomized controlled trials have addressed this
important clinical question to date.
The heart team needs to be aware of the potential challenges of TAVR,
including its vascular complications. Because there is a paucity of data
documenting the relationship and clinical effects of steroid therapy on
vascular complications in patients who underwent TAVR, we performed
this systematic review with a meta-analysis of studies examining the use
of steroids and its clinical outcomes, mainly vascular-related complica-
tions, in patients who underwent TAVR.
Materials and methods
Eligibility criteria, databases, and search strategy
This study followed the Preferred Reporting Items for Systematic
Reviews and Meta-analyses (PRISMA) reporting guidelines.
8
In addition,
using the Population, Interventions, Comparison, Outcome, and Study
(PICOS) design strategy, studies were included if the following criteria
were fulfilled:
1. The population was comprised of patients who underwent TAVR.
2. In 1 arm, patients were receiving corticosteroids.
3. In the other arm, patients were not receiving corticosteroids.
4. Outcomes studied included any of the following: vascular compli-
cations and life-threatening bleeding clearly defined using a stan-
dardized end points definition
9,10
; etiology for the vascular
complication with its treatment, acute kidney injury (AKI), annular
rupture, acute coronary obstruction, cardiac tamponade, closure
device failure, permanent pacemaker implantation (PPI), or peri-
procedural myocardial infarction (MI).
5. The study design was retrospective, prospective, randomized, or
nonrandomized.
The following databases were searched for studies meeting our inclu-
sion criteria and published by June 10, 2022: PubMed/MEDLINE, Embase,
Cochrane Database, Google Scholar, ScienceDirect, and Web of Science. In
addition, we searched for the following terms: (“transcatheter aortic valve
implantation”OR “transcatheter aortic valve replacement”OR “TAVI”OR
“TAVR”OR “aortic valve”OR “aortic valve stenosis”OR “aortic valve
disease”)AND(“steroid therapy”OR “corticosteroid therapy”OR “oral
steroids”OR “systemic steroids”)AND(“vascular complications”OR
“vascular repair”OR “complications”). The following steps were taken for
study selection: (1) identification of titles of records through database
search; (2) removal of duplicates; (3) screening and selection of abstracts;
(4) assessment for eligibility through full-text papers; and (5) final inclu-
sion in the meta-analysis. Studies were selected by 2 independent re-
viewers (C.M. and F.M.). There were no language restrictions. The third/
fourth reviewers arbitrated discrepancies to achieve consensus (T.P. and
R.L.). This study was registered in PROSPERO (CRD42022339352).
End points, assessment of publication bias, and statistical analysis
The study’s primary end points were vascular complications, life-
threatening bleeding, and 30-day mortality, clearly defined using a
standardized end points definition.
9,10
The secondary end points were
Figure 1. Risk of bias summary ROBINS-I tool with traffic lights (A) and summary plot (B).
F.Y. Macedo et al. Journal of the Society for Cardiovascular Angiography & Interventions xxx (xxxx) xxx
2
etiology for the vascular complication with its treatment, AKI, annular
rupture, acute coronary obstruction, cardiac tamponade, closure device
failure, and PPI or periprocedural MI.
The Risk of Bias in Nonrandomized Studies of Interventions tool was
systematically used to assess included studies for risk of bias.
11
The
papers and their characteristics were classified into a low, moderate,
and severe risk of bias (P.V. and J.F.). Two independent reviewers
(M.P.S. and B.R.) assessed the risk of bias. When there was a
disagreement, the senior reviewers (T.P. and R.K.) checked the data and
made the final decision.
Risk ratios with 95% CIs for the crude end points were calculated.
The ratios were calculated as corticosteroid use versus non-
corticosteroid use. For other comparative data, differences in means
with 95% CIs and Pvalues were considered. Forest plots were con-
structed to represent clinical outcomes. Chi-square and I
2
tests were
performed for assessment of statistical heterogeneity.
12
Proportions
were combined across the studies using a random-effects model.
13
A
funnel plot was generated for each outcome to assess the publication
bias, and it was statistically evaluated using the Begg and Mazumdar
test
14
and Egger test,
15
if feasible. Sensitivity analyses on the primary
end point, excluding the studies that were deemed to have an overall
seriousbiasinFigure 1, were also performed. The major interest is
how the meta-analytical point estimates the risk ratio difference be-
tween the meta-analysis when all studies are included versus the
meta-analysis that excludes the potentially-severely-biased studies. A
Table 1. Baseline characteristics.
Characteristic Corticosteroid
(n ¼278)
No corticosteroid
(n ¼3969)
Pvalue
Age, y 80.7 2.5 82 1.5 .23
Female sex 138 (49%) 2207 (55%) .46
Hypertension 192 (69%) 1866 (47%) .001
Hyperlipidemia 77/179 (43%) 766/2977 (25%) .001
Diabetes mellitus 87 (31%) 1136 (28%) .34
Chronic kidney disease 40 (14%) 806 (20%) .02
Previous MI 27 (9.7%) 299 (7.5%) .10
Previous stroke 52 (18%) 507 (12%) .04
Peripheral vascular disease 33 (12%) 594 (15%) .15
Coronary artery disease 97 (35%) 1442 (36%) .70
Atrial fibrillation 114 (41%) 1357 (34%) .02
EuroScore II
a
5.2 4.6 .78
Ejection fraction, % 56 6563.7 .90
Values are mean SD or n (%), unless otherwise noted.
MI, myocardial infarction.
a
Median.
Figure 2. Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) flowchart.
F.Y. Macedo et al. Journal of the Society for Cardiovascular Angiography & Interventions xxx (xxxx) xxx
3
meta-regression analysis was carried out to analyze the impact of
corticosteroid duration on primary outcomes, aiming to assess
whethertimevariabilityinthecourseofcorticosteroidtherapycould
modulate the outcome. The Pvalues for Table 1 were compared using
thechi-squaretestforcategoricalvariablesandtheKruskal-Wallis
test for continuous variables. Statistical analyses were conducted
using Jamovi ‘built-in’R version 3.2 and Origin Pro 2020b. All values
were 2-tailed, and P<.05 was set as the threshold for statistical
significance.
Results
Patients characteristics
Our search retrieved 97 entries, which were reduced to 6 studies after
an initial prescreening. Three studies were excluded based on the excluded
criteria. In the eligibility assessment, 1 additional study was excluded
because it compared corticosteroids in TAVR versus surgical aortic valve
replacement, and there was no control group.
16
Finally, 5 studies
17–21
were
available for the analysis (1 propensity-matched) with 4247 patients
(corticosteroid users: 278; noncorticosteroid users: 3969). Our search
strategy is displayed in Figure 2. All studies retrieved based on our search
analysis and includedin this study were nonrandomized. Of note, there are
no randomized controlled trials on this subject. Table 2 includes the
included studies with some important demographic and design details.
Figure 1 shows the qualitative assessment of the studies with the Risk of
Bias in Nonrandomized Studies of Interventions tool. There were some
concerns regarding confounders in the analyses due to differences between
the groups regarding the risk, age, sex, prevalence of chronic obstructive
pulmonary disease, and kidney disease. These differences might lead to the
effect of bias in the moderate- to high-risk range.
Baseline characteristics
Across studies, patients were slightly predominantly female, older,
and had a mean left ventricular ejection fraction of more than 50% with
an intermediate Logistic EuroScore II. The absolute number and per-
centages of patients with hypertension, hyperlipidemia, diabetes melli-
tus, chronic kidney disease, previous MI, previous stroke, peripheral
arterial disease, coronary artery disease, and atrial fibrillation were also
available and are summarized in Table 1.
Primary outcomes
The analysis of this study’s primary outcome, including the rates of
vascular complications (both major and minor), life-threatening
bleeding, and 30-day mortality, is shown in the Central Illustration
and Figure 3A, respectively. There was a statistically significant dif-
ference in the vascular complication rates between patients on corti-
costeroids and those who were corticosteroid-free (relative risk [RR],
0.63; 95% CI, 0.35-0.90; P<.001). Heterogeneity within the included
studies was low (I
2
¼0%), as seen in the Central Illustration (left). The
follow-up period for this outcome varied among the studies from 30 to
763 days. In our sensitivity analyses, after excluding the studies with a
high risk of bias, as shown in Figure 1, the difference between groups
was no longer observed (RR, 0.2; 95% CI, -0.63 to 1.04; P¼.057),
despite a higher heterogeneity (I
2
¼64.75%). Life-threatening bleeding
rates were also analyzed in 3969 patients from 5 studies (Figure 3A).
There was a statistically significant difference in life-threatening
bleeding rates between patients undergoing TAVR taking corticoste-
roids and those who were not (RR, 0.80; 95% CI, 0.36-1.25; P¼.003).
Heterogeneity within the included studies was low (I
2
¼7.5%), and to
further explore this finding and its association with mortality, an
Table 2. Summary of included studies.
Reference, year Design Country N (total)/corticosteroid arm Length of corticosteroid
therapy prior to TAVR
Criteria used to define the
primary vascular outcomes
Fink et al,
17
2016 Nonrandomized; retrospective;
single center
Israel 220/25 (11.3%) 1390 d (mean)/900 d (median) VARC-2
Havakuk et al,
18
2016 Nonrandomized; prospective;
single center
Israel 324/39 (12%) 3 d VARC
Koyama et al,
19
2020 Nonrandomized; prospective;
multicentric registry
Japan 1313/67 (5%) At least more than 30 d VARC-2
Gautier et al,
20
2020 Nonrandomized; retrospective;
single center
France 1299/48 (3.7%) At least more than 30 d VARC-2
Joshi et al,
21
2022 Nonrandomized; retrospective;
single center
United States 1091/99 (9%) N/A VARC-2
TAVR, transcatheter aortic valve replacement; VARC, Valve Academic Research Consortium.
Central Illustration. Left: Random-effects meta-analysis of vascular complications in patients who underwent transcatheter aortic valve replacement using corti-
costeroids versus those who were not. Right: Random-effects meta-analysis of 30-day mortality associated with transcatheter aortic valve replacement in patients
using corticosteroids versus those who were not.
F.Y. Macedo et al. Journal of the Society for Cardiovascular Angiography & Interventions xxx (xxxx) xxx
4
analysis of 30-day mortality was carried out. There was no significant
difference in the 30-day mortality between patients on corticosteroids
and those not undergoing TAVR (RR, 0.39; 95% CI: -0.10 to 0.89; P¼
.122). Heterogeneity within the included studies was low (I
2
¼0%). A
meta-regression of the log risk ratio of vascular complications over the
duration of corticosteroid therapy was not significant (P¼.06,
Figure 4), and the same finding was obtained for the log risk ratio of
life-threatening bleeding over the course of corticosteroid therapy
(P¼.9, Figure 3B).
Secondary outcomes
Acute kidney injury, acute coronary obstruction, closure device fail-
ure, PPI, or periprocedural MI did not show any difference between pa-
tients undergoing TAVR who were on corticosteroids versus those who
were not (Figure 5). The follow-up time for the secondary outcomes
varied between 1 and 60 months in those studies that reported such
analysis.
16,17,20
The studies that reported follow-up time for secondary
outcomes this for this outcome varied among studies from 30 to 763
days. The noncorticosteroid arm had fewer vascular complications
compared with the corticosteroid arm for femoral artery stenosis (RR,
1.14; 95% CI, 0.06-2.22), occlusion (RR, 2.05; 95% CI, 0.14-3.97),
femoral artery surgery (RR, 0.88; 95% CI, 0.13-1.62), and femoral an-
gioplasty or stenting (RR, 0.77; 95% CI, 0.10-1.43), as seen in the Central
Illustration (right). In terms of cardiac-related complications, the non-
corticosteroid arm had fewer annular ruptures (RR, 1.41; 95% CI,
0.43-2.38) and less cardiac tamponade (RR, 1.56; 95% CI, 0.67-2.45).
Risk of bias across the studies (publication bias)
In a meta-analysis of a few studies (<10), the asymmetry test
cannot distinguish random bias from true asymmetry. Therefore, our
analysis could not statistically assess the presence of publication bias
appropriately due to the insufficient number of studies in the med-
ical literature (Supplemental Figures S1-S3). A sensitivity analysis
for vascular complications was performed after excluding the studies
with high risk of bias (Supplemental Figure S4)
Discussion
This is the first meta-analysis with meta-regression investigating
thepossibleimpactofcorticosteroid therapy on vascular complica-
tions and major bleeding associated with TAVR. Our study suggests
that treatment with corticosteroids is associated with an increase in
the rate of vascular complications and life-threatening bleeding in
patients undergoing TAVR. This was primarily driven by a statistically
significant increase in femoral artery occlusion, stenosis, femoral ar-
tery surgery, and femoral artery angioplasty or stenting in the patients
receiving corticosteroid therapy. A plausible theory is that cortico-
steroids have been shown to affect wound healing by inhibiting
transforming growth factor-βand insulin-like growth factor 1.
7,22
Reductions in these cells’signaling hormones reduce hydroxyproline
levels, a surrogate marker for collagen formation, leading to a less
compliant arterial bed with poor elasticity.
22
Chronic therapy has also
been further demonstrated to significantly suppress the proliferation
of endothelial progenitor cells.
23
Endothelial progenitor cells partic-
ipate in neovascularization and assist in wound healing by migrating
to areas of injury and modulating the repair process by excreting
proangiogenic factors.
24
Our meta-regression did not find a statistically significant difference
in vascular complication rates in patients with chronic versus acute
corticosteroid use. Corticosteroid use was not associated with worse 30-
day mortality despite an increased risk of vascular access and major
bleeding complications. In addition, there was no statistically significant
difference in the rates of AKI, closure device failure, PPI, periprocedural
MI, or acute coronary obstruction on secondary outcomes. On the other
hand, corticosteroid use was associated with worse cardiac-related
complications, such as annular rupture and cardiac tamponade.
Our study found a statistically significant difference in vascular
complications in patients on corticosteroid therapy versus those without
(RR, 0.63; 95% CI, 0.35-0.90; P<.001). In subgroup analysis, most of
these complications were related to the femoral artery’s vascular access
site used in TAVR. This finding correlates with prior research, which has
demonstrated an increased risk of vascular complications in patients on
Figure 3. (A) Random-effects meta-analysis of life-threatening bleeding associated with transcatheter aortic valve replacement in patients using corticosteroids versus
those who were not. (B) Random-effects meta-regression of life-threatening bleeding versus length of corticosteroid therapy in days. RE, random-effects.
Figure 4. Random-effects meta-regression of vascular complications versus
length of corticosteroid therapy in days. RE, random-effects.
F.Y. Macedo et al. Journal of the Society for Cardiovascular Angiography & Interventions xxx (xxxx) xxx
5
corticosteroid therapy following cannulation of the aorta during cardiac
bypass.
25
The increased complication rate is presumed to result from the
decreased effectiveness of intrinsic wound healing in patients on corti-
costeroid therapy, which can be more pronounced in patients with dia-
betes, leading to possible worse outcomes, which need to be confirmed in
more extensive studies.
22
Previous studies on wound healing after surgery in patients taking
corticosteroids have demonstrated a deleterious effect on wound healing
with long-term corticosteroid therapy and minimal effect with short-term
therapy.
7,22,23
In our analysis, there was a trend toward increased risk of
vascular complication with increased duration of corticosteroid therapy;
however, it was not statistically significant. It is unclear if this trend would
become significant with a larger sample size or if the long-term effects of
corticosteroid use donot represent a deleterious effect in relation to TAVR.
In addition, most of the patients in the studies included in our analysis
were on low doses of corticosteroids, and further evaluation of dose-related
impacts is warranted.
A single-center, observational study on patients receiving chronic
corticosteroid therapy demonstrated increased vascular complications
and major bleeding with an increased risk of coronary perforation
26
in
patients undergoing percutaneous coronary intervention. Our analysis
found similar findings in patients on corticosteroids regarding vascular
complications, including life-threatening access-related bleeding (RR,
0.80; 95% CI, 0.36-1.25; P¼.003), annular rupture (RR, 1.41; 95%
CI, 0.43-2.38), and cardiac tamponade (RR, 1.56; 95% CI, 0.67-2.45),
without an impact in the 30-day mortality (RR, 0.39; 95% CI, -0.10
to 0.89; P¼.122), a reassuring finding. This latter finding may be
related to the chronicity of therapy. A recent analysis of preoperative
corticosteroid use in cardiac surgery found a decrease in bleeding
rates following cardiac surgery.
27
Our study included patients with
both short-term and long-term use of corticosteroid therapy. Our net
result was no statistically significant increase in 30-day mortality
after corticosteroid therapy against those who were not on cortico-
steroid therapy. It is unclear whether this is due to a net neutral
effect because of long-term steroid therapy causing increased
bleeding risks and short-term treatment causing decreased bleeding
risks.
While our analysis adds to emerging evidence that corticosteroid use
is associated with an increased risk of vascular complications and life-
threatening bleeding, many factors remain to be investigated. Further
studies on chronic versus acute corticosteroid use and the dose-effect
relationship are warranted. The use of vascular closure devices should
be controlled in these studies. Comorbidities are another aspect that is
difficult to control, as patients with large-vessel vasculitis are often on
chronic corticosteroid therapy and would be presumed to have a higher
risk of vascular complications from their disease and not necessarily from
the corticosteroids themselves.
Limitations
This study has several limitations, mainly because of the limited
studies on the topic. The retrieved data are based on observational
studies with limited follow-up and may not apply to different patient
populations. Randomized controlled trials are needed to determine the
role of corticosteroid therapy and vascular complications in patients
undergoing procedures with large bore access. Meanwhile, in the
absence of definitive evidence, careful evaluation of patients on an in-
dividual basis is of paramount importance to determine if these pro-
cedures can be safely carried out in those individuals who require steroid
therapy.
Conclusion
In conclusion, this is the first meta-analysis with meta-regression that
showed a higher risk for vascular complications and life-threatening
bleeding in patients on corticosteroid therapy undergoing TAVR
despite no increase in the 30-day mortality. Furthermore, in our sec-
ondary outcomes, those on corticosteroids are at increased risk for
cardiac-related complications (annular rupture and cardiac tamponade)
and access site complications requiring more peripheral interventions or
surgical procedures.
Declaration of competing interest
Dr Pasala has received educational grants from Medtronic and is a
speaker for Phillips Healthcare. Dr Villablanca is a consultant for
Edwards, Teleflex, and Angiodynamic and a proctor for Edwards. Dr
Kaple is a speaker for Abbott and Edwards. Dr Vieira is a speaker for
Novartis and Boehringer Ingelheim-Lilly. Dr Ramlawi has received
financial support from Medtronic, Corcym, and AtriCure. Dr S
a receives
support from the Thoracic Surgery Foundation (the charitable arm of the
Society of Thoracic Surgeons) through the TSF Every Heartbeat Matters
Global Structural Heart Fellowship Award. Drs Macedo, Lago, and Mejia-
Otero have no financial conflicts to disclose.
Figure 5. Random-effects meta-analysis of the secondary outcomes in patients who underwent transcatheter aortic valve replacement using corticosteroids versus
those who were not. AKI, acute kidney injury; MI, myocardial infarction; PPM, permanent pacemaker; PTA, percutaneous transluminal angioplasty; RE,
random-effects.
F.Y. Macedo et al. Journal of the Society for Cardiovascular Angiography & Interventions xxx (xxxx) xxx
6
Funding sources
This research did not receive any specific grant from funding agencies
in the public, commercial, or not-for-profit sectors.
Ethics statement
This study was exempted from the institutional review board’s
approval because it used study (not patient)-level data, publicly available
in the literature.
Supplementary material
To access the supplementary material accompanying this article, visit
the online version of the Journal of the Society for Cardiovascular Angiog-
raphy &Interventions at 10.1016/j.jscai.2022.100446.
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