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\begin{document}

\title{Three-dimensional transesophageal echocardiography is comparable to
multi-slice computed tomography for aortic annulus sizing pre
transcatheter aortic valve replacement}



\author[1]{Augustine Mugwagwa}%
\author[1]{Rebecca Perry}%
\author[1]{Carl Gillebert}%
\author[1]{Tracy Hecker}%
\author[1]{Ajay Sinhal}%
\author[1]{Jean Engela}%
\author[1]{Majo Joseph}%
\affil[1]{Flinders Medical Centre}%


\vspace{-1em}



  
  \date{May 20, 2024}


\begingroup
\let\center\flushleft
\let\endcenter\endflushleft
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\endgroup





\selectlanguage{english}
\begin{abstract}
Background In transcatheter aortic valve replacement (TAVR), accurate
aortic annulus measurements are essential for prosthesis sizing to
ensure procedural success. Although multi-slice computed tomography
(MSCT) is considered the gold standard for aortic annulus measurement
pre TAVR, MSCT might be contraindicated in some patients. Aim In
patients undergoing TAVR, we sought to correlate manual and newer
semi-automated three-dimensional (3D) transesophageal echocardiography
(TEE) aortic annular measurements to MSCT measurements. In addition, we
assessed the reproducibility of these 3D TEE methods. Methods
Retrospective, single centre trial involving 39 patients with severe
symptomatic aortic stenosis (AS) planned for TAVR, who underwent both
pre-procedural MSCT and pre/peri- procedural manual and semi-automated
3D TEE. Results Mean age was 85.3 \selectlanguage{ngerman}± 4.7 years. Both 3D TEE methods
highly correlated with MSCT for annular diameters (semi-automated r
=0.96, p\textless{}0.0001 and manual r=0.84, p\textless{}0.0001) and for
annular areas (semi-automated r=0.96, p\textless{}0.0001 and manual
r=0.82, p\textless{}0.0001). Inter-observer reproducibility was high for
both 3D TEE methods for annular diameters (semi-automated r=0.96,
p\textless{}0.001 and manual r=0.91, p\textless{}0.001) and annular area
(semi-automated r=0.96, p\textless{}0.0001 and manual was 0.95
p\textless{}0.0001). Conclusion Both semi-automated and manual 3D TEE
for sizing of the aortic annulus for TAVR is comparable to MSCT. 3D TEE
methods are easily reproducible. Newer semi-automated 3D TEE has the
best correlation to MSCT. 3D TEE is an excellent alternative imaging
modality for TAVR planning in patients whom MSCT is contraindicated.%
\end{abstract}\selectlanguage{ngerman}%



\sloppy


\textbf{}

\textbf{1. Introduction}

Severe symptomatic aortic stenosis (AS) is associated with a poor
prognosis when managed with medical therapy alone {[}1{]}. Until
recently, severe symptomatic AS has been traditionally treated with
surgical aortic valve replacement (SAVR) with better outcomes than
medical therapy alone {[}2-4{]}. Trans-catheter aortic valve replacement
(TAVR) is superior to best medical therapy alone in severe symptomatic
AS patients who are deemed inoperable {[}5,6{]}. Indeed TAVR has
revolutionised the treatment of patients with severe symptomatic AS,
offering a less invasive alternative to surgery. TAVR is now a
well-established alternative to SAVR for the management of patients with
severe symptomatic AS who are at high or moderate surgical risk
{[}7-12{]}. Recent evidence demonstrates similar efficacy with TAVR
comparable to surgery in low surgical risk patients as well {[}13,14{]}.
There's also an ongoing trial for TAVR in severe asymptomatic AS
patients, which if positive will increase the already growing population
of patients eligible for TAVR {[}15{]}. This cumulative evidence has
resulted in the exponential rise of TAVR procedures. In 2015 TAVR
procedures were estimated to be around 300 000 per year worldwide by the
year 2025 {[}16{]}. This estimate is likely to increase further with the
emergence of recent TAVR data from randomised controlled trials.

Correct sizing of the TAVR device which is determined by aortic annulus
size is imperative for procedural success. This is pivotal for avoiding
paravalvular aortic regurgitation (PVAR) post TAVR, coronary obstruction
and aortic root trauma. Under sizing in particular is associated with
PVAR {[}17-19{]}. All grades of PVAR are associated with worse outcomes
whether it is at least moderate PVAR, {[}20-22{]} or even mild PVAR
{[}23{]}. Multi-slice computed tomography (MSCT) is now considered the
gold standard for the measurement of the aortic annulus to determine
TAVR device sizing {[}24-29{]}. Two dimensional (2D) and
three-dimensional (3D) transesophageal echocardiography (TEE) has
previously been shown to generally underestimate the annulus size and
hence TEE is not as widely accepted as MSCT for the aortic annular
sizing for TAVR device {[}30-34{]}.

However in some patients, MSCT might not be feasible such as those with
well documented anaphylaxis to iodinated contrast or those with chronic
kidney disease (CKD). Moreover, TAVR is commonly considered in elderly
patients who often have CKD and are at a higher risk of contrast induced
nephropathy (CIN). In these instances where MSCT might not be ideal, 3D
TEE is a reasonable imaging modality for aortic annulus sizing to
determine TAVR device sizing, especially with recent improvements in 3D
TEE technology that address previous pitfalls. The off-label use of
newer commercially available software (Q-lab MVQ software version 8.1;
Philips Medical Imaging, Andover, MA) normally designed to track the
mitral annulus has been described in this setting for 3D TEE
semi-automated aortic annulus sizing with good success {[}35-36{]}.

The aim of our study was to determine the accuracy of aortic annulus
sizing using (i) manual 3D TEE and (ii) more recent 3D semi-automated
TEE annular detection software in patients undergoing TAVR procedures
who had already undergone pre-planning MSCT in measuring annular
measurements. In addition we sought to assess the reproducibility of
these 3D TEE methods.

\textbf{2. Methods}

\textbf{2.1 Patient population}

Patients with severe symptomatic AS scheduled to undergo TAVR at
Flinders Medical Centre between March 2013 and June 2015, who had both
3D TEE and MSCT images available were included in this study. During
this period all patients who underwent TAVR had general anaesthesia and
peri-procedural TEE performed. However, our current default protocol
particularly for transfemoral TAVR is conscious sedation with the use of
periprocedural transthoracic echocardiogram (TTE). Peri-procedural TEE
is now only performed in a few select cases especially those of
alternate vascular access. A balloon expandable Edwards SAPIEN XT
transcatheter heart valve was implanted in all cases. TAVR sizes were
predicted using standard measurements for Edwards Lifesciences SAPIEN
transcatheter heart valves. The final sizing of the prosthesis was
determined by the implanting physician using all available data. MSCT
was performed 17.0 \selectlanguage{ngerman}± 11.0 weeks prior to TAVR. TEE was performed
peri-procedurally. 3D TEE images were analysed offline. 3D TEE and MSCT
measurements were performed separately in a blinded fashion. 3D TEE
measurements were performed by cardiologists with expertise in
echocardiography. The cardiologists were blinded from the MSCT
measurements to eliminate measurement bias thereby ensuring validity of
the comparisons between these imaging modalities. MSCT measurements were
performed by an experienced radiologist. Informed consent was obtained
from each patient and the study protocol conforms to the ethical
guidelines of the 1975 Declaration of Helsinki as reflected in a priori
approval by the Southern Adelaide Clinical Human Research Ethics
Committee.

\textbf{2.2 Image acquisition}

\textbf{2.2.1 Echocardiography}

Patients underwent procedural TEE using a commercially available machine
(iE33, Philips Medical Imaging, Andover MA) with the X7-2 3D TEE probe.
3D data sets that included the left ventricular outflow tract using a
single beat 3D zoom function were obtained from the aortic long axis
view.

\textbf{2.2.2 MSCT}

All examinations were performed on a Philips Brilliance iCT 256 scanner
using standard technical parameters.

\textbf{2.3 Image analysis}

\textbf{2.3.1 3D manual TEE aortic annulus measurement}

Multiple 3D zoom datasets were acquired and the dataset with the maximal
aortic diameter was used for analysis. We routinely used biplane imaging
from the aortic short axis view to ensure correct alignment of the
orthogonal long axis plane through the maximal diameter. This has been
previously shown to be a robust method of aortic annular measurement
{[}37{]}. From our experience we find this easily reproducible. For 3D
manual TEE aortic annulus measurement commercially available 3D software
(Qlab 3DQ V10.1) was used. A multi-planar reconstructive mode was used
to ensure accurate alignment of the aortic annulus. The data set was
scrolled to maximal aortic valve opening in mid-systole and the 2
orthogonal long axis images (\textbf{Figure 1} , frame B and C) aligned
to open up the left ventricular outflow tract. The transverse
plane\textbf{(Figure 1} , frame A) was then aligned to transect through
the aortic annulus at the insertion point of the aortic valve in both
long axis views. The transverse plane was then used to measure both
annulus area and minimum and maximum diameters.

\textbf{2.3.2 3D semi-automated TEE aortic annulus measurement}

Semi-automated aortic annulus measurements were made using the MVN
program, normally designed for detecting the mitral valve annulus. This
was achieved by scrolling the image in a multi-planar reconstruction
mode to maximal aortic valve opening, aligning the aorta in an upright
direction in the 2 orthogonal planes (figure 3, frame A and B) and
defining the 4 annular points of aortic valve insertion. The software
then automatically placed the remaining annular points with the operator
able to manually override this placement if there was disagreement in 8
long axis frames of the aorta (giving 16 points of annular placement)
Manual override of the automated placement of the annulus points did
occur in at least 2 or more places for the majority of patients and
tended to occur most often in the setting of acoustic shadowing by
valvular calcium. However any adjustment made was minor in nature and
did not add significantly to analysis time. The software then gave the
circumference and area of the aortic annulus and the area was converted
to a diameter by the equation

D= \(\sqrt{}\left(\frac{A}{\pi}\right)\times 2\) where D=diameter and A=area.

\textbf{2.3.3 MSCT}

Measurements of the aortic annulus were obtained manually on a dedicated
viewing station (Philips Extended Brilliance Workspace) using
multi-planar reconstruction. A dataset of images produced by a scan
throughout the cardiac cycle was reviewed for quality and artefact. A
suitable subset was then selected in the diastolic phase (commonly at
the 30 to 35\% point in the cardiac cycle). Using multi-planar
reconstruction of the selected dataset, the plane of the annulus was
determined by selecting the basal attachments (hinge points) of the 3
aortic valve cusps. The 3 hinge points were then connected by a smooth
curved line to create an ellipse along the periphery of the intra-aortic
x-ray contrast density, the ellipse defining the perimeter of the
virtual annulus. Three measurements were then obtained in that plane
viz. maximal and minimal diameters, perimeter and cross sectional area.

\textbf{2.4 Statistical analysis}

Continuous variables are reported as mean ± standard deviation (SD) and
discrete variables as number and percentage. Correlation between imaging
methods was performed using Pearson's correlation and displayed using
Bland-Altman plots. Statistical analysis was performed using Statistical
Package for the Social Sciences (SPSS) version 19.0 with statistical
significance defined as p \textless{} 0.05.

\textbf{3. Results}

\textbf{3.1 Patient characteristics}

39 patients with severe symptomatic AS had annular measurements
performed by 3D TEE and MSCT analysis. Mean age was 85.3 ± 4.7 years.
67\% were male. Prior to intervention aortic mean gradient was 44.5 ±
15.2mmHg and mean aortic valve area was 0.83 ±
0.20cm\textsuperscript{2}. All patients received an Edwards-Sapien XT
TAVR prosthesis. There were 8 (21\%) 23mm, 23 (58\%) 26mm and 8 (21\%)
29mm valve sizes implanted. Patient and echocardiographic
characteristics are shown in \textbf{Table 1.}

\textbf{3.2 Annular measurements and reproducibility}

A comparison of the aortic annular measurements between MSCT and both 3D
TEE methods are shown in \textbf{Table 2} . Both 3D TEE methods highly
correlated with MSCT for annular diameters (semi-automated r =0.96,
p\textless{}0.0001 and manual r=0.84, p\textless{}0.0001) \textbf{Figure
3} and for annular areas (semi-automated r=0.96, p\textless{}0.0001 and
manual r=0.82, p\textless{}0.0001) \textbf{Figure 4} . MSCT and
semi-automated 3D TEE annular area measurements predicted similar TAVR
prosthesis size except in only 1 patient where the semi-automated 3D TEE
annular area size actually suggested a bigger TAVR prosthesis size,
compared to MSCT annular area size. On the other hand, MSCT and manual
3D were discordant in 5 patients in predicting TAVR annular size. Of
these, manual 3D TEE predicted a smaller TAVR prosthesis in 3 patients,
compared to MSCT annular area measurements. Inter-observer
reproducibility was high for both 3D TEE methods for annular diameters
(semi-automated r=0.96, p\textless{}0.001 and manual r=0.91,
p\textless{}0.001) \textbf{Figure 5} and annular areas (semi-automated
r=0.96, p\textless{}0.0001) and manual was 0.95 p\textless{}0.0001)

\textbf{Figure 6.}

\textbf{4. Discussion}

The key finding of this study is that both manual and newer
semi-automated 3DTEE measurements of the aortic annulus correlate well
with MSCT. It had been previously reported that 3D TEE sizing of the
aortic annulus was unable to accurately predict the implant size of the
TAVR device when compared with MSCT {[}30-34{]}. Thus, MSCT has become
the gold standard imaging modality for TAVR planning {[}29{]}. However,
our findings plus other recent studies suggest that newer and improved
3D TEE technology is comparable to MSCT {[}35,36,38{]}. In the era of
significant improvements in both imaging modalities (MSCT and 3D TEE), a
recent systematic review and meta-analysis suggested that in pre-TAVR
planning, 3D TEE is comparable to MSCT {[}39{]}. Indeed with rapidly
increasing indications for TAVR, there's a crucial role for 3D TEE in
those patients that cannot undergo MSCT. As such, we wish to emphasise
that the 3D TEE should not be forgotten as it is an excellent
alternative for annular sizing pre-TAVR. The main concern for TEE was
annulus under sizing (compared to MSCT) resulting in PVAR. This was not
the case in our cohort, particularly for semi-automated 3D TEE
measurements. Indeed, when using the semi-automated technique for
annulus area (the most robust measurement for sizing), the prosthesis
sizing was different in only one patient which suggests that there is no
real clinical difference between the two modalities. Moreover, in this
single case the difference in measurements was only marginal and the 3D
TEE actually predicted a larger prosthesis size. The inter-observer
variability was very low when using the semi-automated 3D TEE method
indicating that automating some of the measurement reduced the
difference between readers. Our study provides great confidence in not
only choosing 3D TEE when MSCT is contra-indicated but suggests that it
is an excellent alternative regardless. Therefore, with better 3D TEE
analysis packages specifically designed for the aortic annulus now
available on the market which often use identical techniques to MSCT
measurement methods, the mantra that MSCT is the gold standard needs to
be revisited by further comparative studies {[}32,34{]}. Whether using
3D TEE alone in these cases will result in similar procedural outcomes
such as PVAR compared to MSCT is not well known at this stage, but the
fact that these two different imaging modalities chose the same
prosthesis size in nearly all cases in our cohort suggests that the
clinical outcomes would likely be comparable.

\textbf{4.1 Limitations}

This study has several limitations. The most important limitation is
that it had a small sample size. It was a single centre trial and we
chose to only use data from the same 3D TEE system. We did not compare
clinical outcomes such as MACE and mortality or measurable
echocardiography parameters such as the presence/severity of PVAR, as 3D
TEE was not solely used as the imaging modality for deciding which TAVR
prosthesis would be implanted. Our findings are not generalisable to
other manual or semi-automated 3D TEE techniques/software other than the
methods that we used.

\textbf{5. Conclusion}

Both semi-automated and manual 3D TEE for sizing of the aortic annulus
for TAVR is comparable to MSCT. 3D TEE methods are easily reproducible
and feasible. Newer semi-automated 3D TEE offers the best correlation to
MSCT. Hence 3D TEE is an excellent imaging modality for TAVR planning in
patients whom MSCT is either contraindicated or suboptimal.

\textbf{Acknowledgements}

The authors would like to acknowledge the assistance of Sophia Englezos
from Life Healthcare with this study.

\textbf{Conflict of interest}

All authors declare no conflict of interest.

\textbf{Author contributions}

Augustine Mugwagwa: Visualisation, Conceptualisation, Writing - Original
draft

preparation, Writing - Reviewing and Editing, Methodology and
Investigation.

Rebecca Perry: Conceptualisation, Methodology, Formal analysis, Writing
- Original draft preparation, Writing - Reviewing and Editing and
Investigation.

Carl Gillebert: Conceptualisation, Resources, Writing - Reviewing and
Editing and Investigation.

Tracy Hecker: Conceptualisation, Investigation, Resources and Writing -
Reviewing and Editing.

Ajay Sinhal: Conceptualisation, Investigation, Resources and Writing -
Reviewing and Editing.

Jean Engela: Conceptualisation, Investigation, Resources and Writing -
Reviewing and Editing Validation.

Majo Joseph: Conceptualisation, Resources, Writing - Reviewing and
Editing, Investigation and Supervision.

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\textbf{Figure legend}

\textbf{Figure 1}

A manual 3D TEE image in multi-planar reconstruction mode demonstrating
alignment of the image. The transverse plane is aligned to transect
through the aortic annulus at the insertion point of the aortic valve in
both long axis views (frame B and C). The transverse plane was then used
to measure both annulus area and minimum and maximum diameters (frame
A).

Abbreviations:

Ao -- ascending aorta; Av -- aortic valve; Ava -- aortic valve annulus;
LVot -- left ventricular outflow tract

\textbf{Figure 2}

Semi-automated aortic annulus measurement. This image is achieved by
scrolling the image in a multi-planar reconstruction mode to maximal
aortic valve opening, aligning the aorta in an upright direction in the
2 orthogonal planes (frame A and B) and defining the annular points of
aortic valve insertion. Frame C demonstrates the 2D plane of the annulus
and frame D is the 3D reconstruction of the annulus.

Abbreviations:

A -- anterior; AL -- anterolateral; Ao -- ascending aorta; Av -- aortic
valve; Ava -- aortic valve annulus; LVot -- left ventricular outflow
tract; P -- posterior; PM - posteromedial

\textbf{Figure 3}

Bland-Altman graphs demonstrating the correlation in aortic annulus
diameters between MSCT and manual 3D TEE (frame A) and semi-automated 3D
TEE (frame B).

\textbf{Figure 4}

Bland-Altman graphs demonstrating the correlation in aortic annulus
areas between MSCT and manual 3D TEE (frame A) and semi-automated 3D TEE
(frame B).

\textbf{Figure 5}

Bland-Altman graphs demonstrating the inter-operator variability of
aortic annulus diameter using manual 3D TEE (frame A) and semi-automated
3D TEE (frame B).

\textbf{Figure 6}

Bland-Altman graphs demonstrating the inter-operator variability of
aortic annulus area using manual 3D TEE (frame A) and semi-automated 3D
TEE (frame B).

\textbf{Hosted file}

\verb`Table 1..docx`  available at \url{https://authorea.com/users/323179/articles/452000-three-dimensional-transesophageal-echocardiography-is-comparable-to-multi-slice-computed-tomography-for-aortic-annulus-sizing-pre-transcatheter-aortic-valve-replacement}

\textbf{Hosted file}

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