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\begin{document}

\title{First experience with the novel AcQCross[?] Qx system combined with
Medtronic FlexCath TM Advance steerable sheath for cryoballoon pulmonary
vein isolation.}



\author[1]{Simone Zanchi}%
\author[1]{Carmelo La Greca}%
\author[1]{Amedeo Prezioso}%
\author[1]{Joseph Antoine Kheir}%
\author[1]{Domenico Pecora}%
\affil[1]{Fondazione Poliambulanza Istituto Ospedaliero}%


\vspace{-1em}



  
  \date{May 29, 2024}


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\selectlanguage{english}
\begin{abstract}
Transseptal puncture is a fundamental learning step for a young
electrophysiologist. New technologies have been developed to reduce the
complexity of the procedure and improve safety. One of them is
AcQCross[?]Qx. Our aim is to discuss our procedural approach with this
new technology, during cryoballoon pulmonary vein isolation.%
\end{abstract}%



\sloppy


\textbf{Introduction}

Transseptal puncture (TSP) is the crucial step in a variety of cardiac
procedures, including left side ablations\textsuperscript{1}. The TSP
technique was introduced into clinical practice during the late 1950s by
Ross et al.\textsuperscript{2} , and over the years the procedure has
remained unchanged, except for the introduction of a new needle by
Brockenbrough\textsuperscript{3} in 1960s. TSP is a relatively safe
procedure, even though complications related to TSP can be severe and
life threatening, as a consequence special training is required, and
only expert operators should perform TSP\textsuperscript{4}. New
technologies have been developed in order to simplify the puncture and
increase its safety, however none of them has become the new standard
tool for TSP. Recently a novel transseptal crossing device (AcQCross[?]
Qx, Medtronic) was introduced: it has an integrated needle/dilator
design, which removes the need for needle and guidewire exchange after
TSP; it fits with the different existing sheaths; and the needle can
also work with radiofrequency, in case of need. The aim of our paper is
to describe our first experience with this novel technology applied for
cryoballoon atrial fibrillation (AF) ablation, under fluoroscopy and
pressure guidance.

\textbf{Case Report}

A 68-year-old male was referred to our centre for a primary AF and
atrial flutter (AFL) ablation. His past medical history included
dyslipidaemia and a previous interstitial pneumonia SARS-CoV-2 related,
complicated by bilateral pulmonary embolism and typical atrial flutter,
treated by pharmacological cardioversion. Since hospital discharge the
patient has suffered from frequent atrial fibrillation episodes, as
documented by multiple smartwatch ECG registrations. Laboratory blood
investigations showed the following: hemoglobin, 15,8 g/dL; white cell
count, 7.8 x 10\textsuperscript{9}/L; sodium, 143 mmol/L; potassium, 4.0
mmol/L; urea, 27 mg/dL; and creatinine, 0,8 mg/dL. An echocardiogram
documented normal biventricular size and function with normal left
atrial dimensions and normal valvular function. As patient's
CHA(2)DS(2)-VASC was 1, according to our internal protocol, a
transesophageal echocardiography was not performed. The procedure was
made under uninterrupted anticoagulation with edoxaban. The patient
provided written informed consent prior to the ablation procedure. The
electrophysiological procedure was performed in deep sedation. After
obtaining ultrasound-guided 2 left and 1 right femoral venous
access\textsuperscript{5}, a decapolar diagnostic catheter (Dynamic
XT\textsuperscript{TM}, Boston Scientific) was placed into coronary
sinus (CS) and a steerable quadripolar diagnostic catheter (Dynamic
TIP\textsuperscript{TM}, Boston Scientific) was placed into the right
ventricle. A 0.032 J-tip guidewire was placed from the right femoral
access site to the superior vena cava (SVC). The AcQCross[?] Qx system
combined with Medtronic FlexCath\textsuperscript{TM} Advance steerable
sheath was placed over the guidewire to the SVC. The AcQCross[?] Qx
system was then connected to a pressure line by an Y connector (Fig.1A).
After retracting the guidewire to the tip of the dilator, the sheath was
pulled back caudally until an abrupt leftward movement (jump) of the tip
below the aortic knob is observed (in the postero-anterior view) as the
tip passes under the muscular atrial septum onto the fossa ovalis. After
confirming the position of the tip in RAO and LAO view, the slider
button was advanced forward on the AcQCross[?] Qx proximal handle,
inducing the protrusion of the hollow stainless steel needle and
resulting in effective puncture of the fossa ovalis (Fig.2A), as
confirmed at first by the pressure line which showed LA pressure
(Fig.1B). Thereafter the retained guidewire was easily advanced into LA
and placed distally into the left superior pulmonary vein (Fig.2B) and
finally the steerable sheath was advanced into the LA over the wire
(Fig.2C-D). In this case the delivery of radiofrequency via the needle
in order to puncture the septum was not necessary. The cryoballoon was
then advanced without any need of sheat exchange and a conventional
pulmonary vein isolation (PVI) with single application of cryoenergy for
240 sec per vein was performed. After PVI and during proximal CS pacing,
an ablation index-guided cavotricuspid isthmus ablation with point by
point lesions using 3D mapping (Carto 3, Biosense Webster) was
performed. At the end of procedure an echocardiogram documented absence
of pericardial effusion. The procedural data are displayed in Table 1.
On the same evening of procedure an echocardiogram documented absence of
pericardial effusion. On the next day after a clinical evaluation the
patient was discharged. A follow-up with Holter ECG and medical
evaluations at 3, 6 and 12 months from the ablation was scheduled.

\textbf{Discussion}

We present the first reported case of the use of a novel integrated
dilator and needle system (AcQCross[?] Qx) in combination with a 15F
steerable sheath (Medtronic FlexCath\textsuperscript{TM}) to perform a
cryoballoon procedure, without the need of sheath exchange. So far, a
few experiences with the AcQCross[?] Qx system have been
published\textsuperscript{1,6,7}, which documented safety and improved
procedural efficacy, as the time needed for TSP was significantly lower
in AcQCross Qx groups as compared to traditional TSP approach. The main
novelty of our approach consists in TSP monitoring. While Rizzi et
al.\textsuperscript{1} and Yap et al.\textsuperscript{6,7} performed TSP
respectively under transesophageal echocardiography monitoring the
former and intracardiac imaging the latter, we chose to safely perform
TSP with AcQCross[?] Qx system under fluoroscopy monitoring. The
connection to a pressure line by using an Y connector allowed us to
confirm the position of the needle by checking LA pressure after its
protrusion and after that we could safely advance the guidewire into
left superior pulmonary vein. This double check of LA pressure and
fluoroscopically correct guidewire position before advancing the 15 F
steerable sheath provides safety and reduces the need of cardiac imaging
during the procedure. Eventually, AcQcross[?] Qx seems to be a promising
novel TSP system, which has the potential to reduce the need of x-rays,
the risk of air embolism due to sheath exchanges, and the complexity of
TSP preserving safety by using echocardiographic monitoring or the
double check suggested in this paper. Also young electrophysiologists
and EP fellows may benefit from this new technology, as lowering
complexity of this procedure could lead to a steeper learning curve.
Further clinical studies need to be done to verify safety and
feasibility outcomes and to finally assess the effective relevance of
this new technology.

\textbf{Key clinical message}

The novel Cross[?] Qx system is a promising transseptal crossing device
with integrated needle, which can be used with several existing sheaths
with no need of sheath exchange after TSP. Fluoroscopy and pressure
monitoring instead of cardiac imaging can be employed during TSP in
order to ensure procedural safety.

\textbf{References:}

1. Rizzi S, Pannone L, Monaco C, et al. First experience with a
transseptal puncture using a novel transseptal crossing device with
integrated dilator and needle. J Interv Card Electrophysiol.
2022;65(3):731-737. doi:10.1007/s10840-022-01329-3

2. Ross J. et al. Transseptal Left Atrial Puncture. New technique for
the measurement of left atrial pressure in man. Volume 3, Issue 5,
p653-655, may 01, 1959. DOI:https://doi.org/10.1016/0002-9149(59)90347-9

3. Brockenbrough EG, Braunwald E. A new technic for left ventricular
angiocardiography and transseptal left heart catheterization. Am J
Cardiol. 1960;6(6):1062-1064. doi:10.1016/0002-9149(60)90361-1

4. Russo G, Taramasso M, Maisano F. Transseptal Puncture: A Step-by-Step
Procedural Guide. Cardiac interventions today may/june 2019 vol. 13, no.
3

5. Greca CL. Advantages of the integration of ICE and 3D
electroanatomical mapping and ultrasound-guided femoral venipuncture in
catheter ablation of atrial fibrillation. J Interv Card Electrophysiol.

6. Yap SC, Szili-Torok T. Optimization of the transseptal procedural
workflow using a novel integrated dilator and needle during a
cryoballoon procedure. Hear Case Rep. 2022;8(1):60-63.
doi:10.1016/j.hrcr.2021.11.001

7. Yap SC, Bhagwandien RE, Szili-Torok T. Use of a novel integrated
dilator-needle system in cryoballoon procedures: a zero-exchange
approach. J Interv Card Electrophysiol. 2022;65(2):527-534.
doi:10.1007/s10840-022-01294-x

\textbf{Figure legend}

\textbf{Fig.1 A} Connection between AcQCross[?] Qx to a pressure line and
a contrast agent by an Y connector; \textbf{B} Left atrial pressure
detected by pressure line after transseptal puncture.

\textbf{Fig.2 A} Protrusion of the hollow stainless steel needle and
effective puncture of the fossa ovalis after sheath's tenting;\textbf{B}
guidewire positioning into the left superior pulmonary vein;\textbf{C}
steerable sheath's direct advancement into the left atrium over the
wire; \textbf{D} AcQCross[?] Qx withdrawal after transseptal puncture.

\textbf{Table 1. Procedural data. LA left atrium, AFL atrial flutter,
TSP transseptal puncture, DAP dose area product}\selectlanguage{english}
\begin{longtable}[]{@{}ll@{}}
\toprule
Total procedural time (min) & 90\tabularnewline
\midrule
\endhead
LA time (min) & 45\tabularnewline
AFL ablation time (min.) & 15\tabularnewline
Total Fluoroscopy time (min:sec) & 6:07\tabularnewline
TSP Fluoroscopy time (min:sec) & 2:03\tabularnewline
Total DAP (mGycmq) & 31894\tabularnewline
\bottomrule
\end{longtable}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/fig1/fig1}

\end{center}
\end{figure}\selectlanguage{english}
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\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/Fig2/Fig2}

\end{center}
\end{figure}

\selectlanguage{english}
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