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\begin{document}

\title{Inter-atrial Septal Balloon Dilation to Facilitate Intracardiac
Echocardiography Guided Left Atrial Appendage Occlusion}



\author[1]{Sandeep Goyal}%
\author[1]{Ashish A. Bhimani}%
\author[2]{Danesh Kella}%
\author[1]{Anahita Tyagi}%
\author[1]{Venkateshwar Polsani}%
\author[1]{Thomas Deering}%
\affil[1]{Piedmont Heart Institute}%
\affil[2]{Mayo Clinic in Florida}%


\vspace{-1em}



  
  \date{May 17, 2024}


\begingroup
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\selectlanguage{english}
\begin{abstract}
Background: Percutaneous left atrial appendage occlusion (LAAO) is
traditionally performed under general anesthesia with trans-esophageal
echocardiography guidance. Intracardiac echo (ICE) guided LAAO closure
is increasing in clinical use. The ICE catheter is crossed into LA via
interatrial septum (IAS) after the septum is dilated with LAAO delivery
sheath. This step can be time-consuming and requires significant ICE
catheter manipulation increasing the risk of cardiac perforation.
Pre-emptive septal balloon dilation can potentially help with the
advancement of ICE in LA. Objective: Evaluate the effect of pre-dilation
of IAS with an 8 mm balloon on ease of crossing the ICE catheter,
fluoroscopy time for crossing, and overall procedure time. Methods: The
Piedmont LAAO registry was used to identify consecutive patients
undergoing LAAO. The initial 25 patients where balloon dilation of IAS
was performed served as the experimental cohort, and the 25 consecutive
patients prior to that in whom balloon dilation was not performed,
served as controls. For the experimental group, after a trans-septal
puncture, the sheath was retracted to the right atrium with guide wire
still in the LA. An 8x40 mm Evercoss over the wire balloon was inflated
across the IAS. The ICE catheter was then crossed into the LA using the
fluoroscopic landmark of the guide wire and the ICE imaging. The sheath
was then advanced along the ICE catheter via the transseptal puncture
(TSP) and the procedure continued. Follow up CT imaging was obtained in
4-8 weeks. Results: Each group included 25 patients. There were no
significant differences in baseline characteristics. All procedures were
performed successfully with the use of conscious sedation and ICE
guidance. There was a significant reduction in overall procedure time,
fluoroscopy time, and time for trans-septal puncture to ICE in LA. There
was no difference in the size of the acute residual interatrial shunt as
measured via ICE or size and presence of iatrogenic ASD at follow up.
Conclusion: Balloon dilation of TSP is safe and associated with
increased efficiencies in ICE guided LAAO procedures.%
\end{abstract}%



\sloppy


\textbf{Introduction:}

Stroke prevention in atrial fibrillation (AF) typically necessitates
either oral anticoagulation (OAC)\textsuperscript{1} or, when OAC is not
suitable, consideration for left atrial appendage occlusion
(LAAO)\textsuperscript{1}. Historically, percutaneous LAAO is performed
under general anesthesia and is guided by trans-esophageal
echocardiography (TEE) \textsuperscript{2,3}The adoption of LAAO is
expanding, owed to heightened procedural success and diminished
complications\textsuperscript{4} . A shift toward Intracardiac echo
(ICE) guided LAAO is evident, aiming to optimize the procedure by
negating the necessity for general anesthesia and
TEE\textsuperscript{5,6} \textsuperscript{7}. However, optimal LAA
imaging from right sided cardiac chambers remains
challenging\textsuperscript{8}, necessitating ICE catheter placement in
the LA. This can be achieved via a second trans-septal puncture or a
singular puncture utilizing the ``buddy'' technique\textsuperscript{6}.
In the latter, the ICE catheter's LA traversal via the interatrial
septum (IAS) follows IAS dilation with the LAAO delivery
sheath\textsuperscript{6},\textsuperscript{9}. This can be prolonged and
demands intricate ICE catheter adjustments, amplifying cardiac
perforation risks. Existing solutions encompass balloon dilation or
snare techniques post unsuccessful crossing
attempts\textsuperscript{6,10}. We hypothesized that preemptive septal
balloon dilation may facilitate ICE introduction in the LA.

Our objective was to assess the impact of an 8 mm balloon pre-dilation
of the IAS on the ease of ICE catheter crossing, fluoroscopy time, and
overall procedural duration.

\textbf{Materials \& Methods:}

This was a retrospective, observational cohort study based on a
single-center prospective LAAO registry at Piedmont hospital, Atlanta,
GA. The Study protocol was approved by the institutional IRB. The first
25 consecutive patients undergoing balloon dilation of IAS during LAAO
served as the experimental cohort. The 25 consecutive patients prior to
that in whom balloon dilation was not performed, served as controls.

Two separate venous accesses were obtained in the right femoral vein
with 8.5 F Versacross sheath and 9-F 45-cm sheaths to accommodate the
transeptal delivery system and the ICE catheter (AcuNav, Siemens
healthcare), respectively. Full anticoagulation was administered before
trans-septal puncture (TSP). An ICE positioned in the mid right atrium
guided the TSP.

For the experimental group, post TSP, the 8.5 F Versacross sheath was
retracted to the right atrium with the guide wire still in the LA. An
8x40 mm Evercross over the wire balloon was placed across the IAS. The
balloon was inflated at nominal pressure for 1 min and retracted back
into the sheath (Figure 1). The ICE catheter was then crossed into the
LA using the fluoroscopic landmark of the guide wire and ICE imaging
(Video 1). ICE imaging was used to decide on appropriate LAAO device and
an LAAO sheath was chosen. The TSP sheath was then exchanged for the
LAAO sheath, which was advanced along the ICE catheter via the TSP and
the procedure continued. In the control group, the Versacross sheath
was exchanged for the LAAO delivery sheath and septum was ``flossed''
with the LAAO sheath and the sheath was pulled to RA. ICE advancement
was then attempted via the same TSP. Once the ICE catheter was in LA,
the LAAO sheath was also advanced into the LA\textsuperscript{6}. The
rest of the procedure was performed in standard fashion. After
completion of LAAO implant, the sheath and ICE catheter were brought to
RA and the size of the atrial septal defect (ASD) was measured on 2D and
color doppler echocardiography.

All patients underwent cardiac CT 4-8 weeks post procedure and the LAAO
device was assessed for position and seal. Assessment was also made of
any residual ASD and its size.

Descriptive statistics were used to analyze the data. Data are reported
as

mean\selectlanguage{ngerman}± SD and median with interquartile range (IQR).

\textbf{Results:}

Each group included 25 patients. There were no significant differences
in the baseline characteristics. All procedures were performed
successfully with the use of conscious sedation and ICE guidance. There
was a significant reduction in overall procedure time, fluoroscopy time,
and time taken from trans-septal puncture to ``ICE in LA''. The overall
procedure time was 54.5 ±20.3 min in the conventional group vs 43.6 ±
4.7 min in the experimental group.~ The fluoroscopy time was 13.2 ±11.2
min in the conventional group vs 6.1 ±1.6 min in the experimental
group.~ The transseptal puncture to ICE in LA time was 5.2 ±7.5 min in
the conventional group vs 2.9 ± 1.2 min in the experimental group (Table
1). There was no difference in the size of the acute residual
interatrial shunt as measured via ICE\emph{.} There were no acute
procedural complications.

Imaging follow up was available on all patients. Timing of imaging was
variable between 30-60 days. There was no difference in size of
iatrogenic ASD in either group. There was one device related thrombus in
control group and one patient with 2 mm peri device leak in the
experimental group.

\textbf{Discussion:}

In this study, we present the outcomes of employing preemptive
balloon-assisted dilation of the interatrial septum to facilitate the
traversal of ICE in the Left Atrium during LAAO. While there have been
isolated case reports describing the occasional utilization of this
approach, our study stands as the first consecutive series that
systematically compares this strategy against the conventional standard
of care\textsuperscript{11}.

Our findings suggest that the routine use of preemptive balloon dilation
of the IAS is correlated with an easier ICE traversal following a single
trans-septal puncture. This approach significantly reduces both the
total time required and the variability in the time needed to
successfully navigate the ICE within the LA (2.9±1.2 minutes compared to
5.2±7.5 minutes).

With the availability of more than one LAAO
device\textsuperscript{10,12}, the choice of device is often made
post-assessment of the Left Atrial Appendage (LAA) during the procedure.
However, opting for a large LAAO access sheath for IAS dilation
necessitates an early decision regarding the device / sheath type before
ICE traversal in the LA. As more LAAO devices gain approval, it becomes
increasingly crucial to defer the device type selection until final
imaging of the LAA can be performed via ICE within the operating suite.
Our proposed approach effectively eliminates the need for unnecessary
utilization of an inappropriate LAAO access sheath, thereby reducing
costs and minimizing the number of device exchanges.

While Intracardiac Echocardiography (ICE) usage is on the rise for LAAO
procedures, a significant majority of these procedures are still
conducted under Transesophageal Echocardiography (TEE) guidance. The key
challenges reported most frequently in the adoption of ICE for LAAO are
the complexities associated with ICE traversal in the LA and obtaining
clear views of the LAA with ICE. Our proposed strategy serves to
expedite the learning curve for ICE traversal within the LA via a single
trans-septal puncture, potentially lowering the barriers to early
adoption of ICE in LAAO procedures.

Furthermore, the 4D ICE technology is increasingly available and being
employed to guide LAAO procedures. However, these catheters typically
possess larger diameters compared to their 2D
counterparts\textsuperscript{13} \textsuperscript{14}. Our technique may
prove particularly valuable in alleviating the challenges associated
with ICE traversal in the LA when using these larger diameter 4D ICE
catheters.

Finally, it is worth noting that ICE is the preferred modality for
imaging during electrophysiologist (EP)-performed ablation procedures,
enhancing the comfort level of EPs with ICE over Interventional
cardiologists (ICs). However, this technique necessitates the use of
large balloon catheters and other IC techniques. LAAO procedures are
often performed by either EPs or ICs. Our approach highlights a unique
opportunity for collaboration between electrophysiologists and
interventional cardiologists, enabling a cohesive team to perform these
procedures and fostering mutual learning.

Nevertheless, it is essential to acknowledge the limitations of this
study. This research represents a single-center, single-operator
investigation, which may limit the generalizability of the results.
However, it is worth noting that we have reported data on consecutive
patients undergoing LAAO outside of clinical trials. Additionally, we
did not base the utilization of ICE or balloon dilation on any
pre-imaging information.

\textbf{Conclusion:}

In conclusion, our study presents a strategy with promising implications
for the field of LAAO procedures, offering enhanced efficiency,
cost-effectiveness, and interdisciplinary collaboration. Further
multi-center studies with multiple operators are warranted to validate
these findings across diverse clinical settings and patient cohorts.

\textbf{References:}

1. January CT, Wann LS, Calkins H, et al.: 2019 AHA/ACC/HRS Focused
Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients
With Atrial Fibrillation: A Report of the American College of
Cardiology/American Heart Association Task Force on Clinical Practice
Guidelines and the Heart Rhythm Society in Collaboration With the
Society of Thoracic Surgeons. Circulation 2019; 140:e125--e151.

2. Holmes DR, Kar S, Price MJ, et al.: Prospective randomized evaluation
of the Watchman Left Atrial Appendage Closure device in patients with
atrial fibrillation versus long-term warfarin therapy: the PREVAIL
trial. J Am Coll Cardiol 2014; 64:1--12.

3. Lakkireddy D, Thaler D, Ellis CR, et al.: Amplatzer Amulet Left
Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis
(Amulet IDE): A Randomized, Controlled Trial. Circulation 2021;
144:1543--1552.

4. Kar S, Doshi SK, Sadhu A, et al.: Primary Outcome Evaluation of a
Next-Generation Left Atrial Appendage Closure Device: Results From the
PINNACLE FLX Trial. Circulation 2021; 143:1754--1762.

5. Alkhouli M, Chaker Z, Alqahtani F, Raslan S, Raybuck B: Outcomes of
Routine Intracardiac Echocardiography to Guide Left~Atrial~Appendage
Occlusion. JACC: Clinical Electrophysiology 2020; 6:393--400.

6. Korsholm K, Jensen JM, Nielsen-Kudsk JE: Intracardiac
Echocardiography From~the~Left~Atrium for
Procedural~Guidance~of~Transcatheter Left~Atrial~Appendage~Occlusion.
JACC Cardiovasc Interv 2017; 10:2198--2206.

7. Jhand A, Thandra A, Gwon Y, et al.: Intracardiac echocardiography
versus transesophageal echocardiography for left atrial appendage
closure: an updated meta-analysis and systematic review. Am J Cardiovasc
Dis 2020; 10:538--547.

8. Ho ICK, Neuzil P, Mraz T, et al.: Use of intracardiac
echocardiography to guide implantation of a left atrial appendage
occlusion device (PLAATO). Heart Rhythm 2007; 4:567--571.

9. Aguirre D, Pincetti C, Perez L, et al.: Single trans-septal access
technique for left atrial intracardiac echocardiography to guide left
atrial appendage closure. Catheter Cardiovasc Interv 2018; 91:356--361.

10. Kawsara A, Raybuck B: Snare and track (SNACK) technique: a novel
approach for successful placement of an intracardiac echocardiogram
catheter in the left atrium: a case report. Eur Heart J Case Rep 2022;
6:ytac365.

11. The Case for Intracardiac Echo to Guide Left Atrial Appendage
Closure - ClinicalKey {[}Internet{]}. {[}cited 2023 Sep 30{]},.
Available from:
https://www.clinicalkey.com/\#!/content/journal/1-s2.0-S2211745821001115

12. Ahmed A, Bawa D, Kabra R, et al.: Left Atrial Appendage Closure with
Watchman vs Amulet Devices: Similarities and Differences. Curr Cardiol
Rep 2023; 25:909--915.

13. Khalili H, Patton M, Taii HA, et al.: 4D Volume Intracardiac
Echocardiography for Intraprocedural Guidance of Transcatheter Left
Atrial Appendage Closure. J Atr Fibrillation 2019; 12:2200.

14. Kaplan RM, Narang A, Gay H, et al.: Use of a novel 4D intracardiac
echocardiography catheter to guide interventional electrophysiology
procedures. J Cardiovasc Electrophysiol 2021; 32:3117--3124.\selectlanguage{english}
\begin{longtable}[]{@{}lll@{}}
\toprule
\begin{minipage}[b]{0.30\columnwidth}\raggedright\strut
Table 1\strut
\end{minipage} & \begin{minipage}[b]{0.30\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[b]{0.30\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
Conventional Group (n=25)\strut
\end{minipage} & \begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
Balloon Dilation Group (n=25)\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
Age (mean\selectlanguage{ngerman}±SD)\strut
\end{minipage} & \begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
79.3 (\selectlanguage{ngerman}±7.9) yr\strut
\end{minipage} & \begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
77.3(\selectlanguage{ngerman}±10.1) yr\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
Sex- Female (\%)\strut
\end{minipage} & \begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
36\%\strut
\end{minipage} & \begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
44\%\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
CHADS2-Vasc score (mean\selectlanguage{ngerman}±SD)\strut
\end{minipage} & \begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
4.3(\selectlanguage{ngerman}±2.1)\strut
\end{minipage} & \begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
4.6(\selectlanguage{ngerman}±1.8)\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
Procedure time (minutes)\strut
\end{minipage} & \begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
54.50 (\selectlanguage{ngerman}± 20.3)\strut
\end{minipage} & \begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
43.6 (\selectlanguage{ngerman}±4.7)\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
Fluoroscopy time (minutes)\strut
\end{minipage} & \begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
13.2 (\selectlanguage{ngerman}±11.2)\strut
\end{minipage} & \begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
6.1 (\selectlanguage{ngerman}±1.6)\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
Trans-septal to ICE in LA time (minutes)\strut
\end{minipage} & \begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
5.2(\selectlanguage{ngerman}±7.5)\strut
\end{minipage} & \begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
2.9 (\selectlanguage{ngerman}±1.2)\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.32\columnwidth}\raggedright\strut
Type of LAAO device (n)\strut
\end{minipage} & \begin{minipage}[t]{0.32\columnwidth}\raggedright\strut
Watchman FLX : 24 Amulet :1\strut
\end{minipage} & \begin{minipage}[t]{0.32\columnwidth}\raggedright\strut
Watchman FLX: 22 Amulet: 3\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
Interatrial septal shunt (mm)\strut
\end{minipage} & \begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
5.6 (\selectlanguage{ngerman}±1.6)\strut
\end{minipage} & \begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
6.1(\selectlanguage{ngerman}±1.3)\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
Interatrial Septal defect (mm)-1st imaging follow up\strut
\end{minipage} & \begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
3.3 (\selectlanguage{ngerman}± 1.1)\strut
\end{minipage} & \begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
3.5 (\selectlanguage{ngerman}±1.2)\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
Iatrogenic ASD present (n)\strut
\end{minipage} & \begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
11\strut
\end{minipage} & \begin{minipage}[t]{0.30\columnwidth}\raggedright\strut
12\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}

\textbf{Table 1:} Baseline and Procedural characteristics of two groups.

Figure and Video Legends:\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image1/image1}

\end{center}
\end{figure}

Figure 1: Panels showing Dilation of interatrial septum on fluoroscopy
and intracardiac echocardiography

Video 1 : Intracardiac echocardiography catheter crossing from right to
left atrium after balloon dilation

\selectlanguage{english}
\FloatBarrier
\end{document}

