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\begin{document}

\title{Perimembranous ventricular septal defect closure via ultra-minimal trans
intercostal incision in children}



\author[1]{Zhan Gao}%
\author[1]{Jin Yu}%
\author[1]{Zewei Zhang}%
\author[1]{Jianhua Li}%
\author[1]{Jiangen Yu}%
\affil[1]{Affiliation not available}%


\vspace{-1em}



  
  \date{May 22, 2024}


\begingroup
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\selectlanguage{english}
\begin{abstract}
Aims:This study aimed to investigate the safety, feasibility and
availability of perimembranous ventricular septal defect (PmVSD) closure
via a left parasternal ultra-minimal trans intercostal incision in
children. Methods and results:From January 2015 to January 2019, 131
children with restrictive PmVSDs were enrolled in this study and
successfully done in 126 patients (96.18\%). PmVSDs were occluded via an
ultra-minimal trans intercostal incision ([?]1 cm), and the entire
occlusive process was guided and monitored by TEE. A pericardium hanging
technique was employed without sternal incision. PmVSDs were closed
through a short delivery sheath assembled using a concentric occluder
device. All patients were followed up for a perid ranging from18 months
to 24 months. Thirteen patients with PmVSD had aneurysm of membranous
septum (AMS). Multistream (more than or equal to 2) PmVSDs with AMS were
found in eleven cases. After the operation, mild residual shunt beside
the amplatzer occluder in one patient was found and had self-healing
result during the 5-month follow-up period. Five patients transferred to
ventricular septal defect repair operation under direct visualization
with a cardiopulmonary bypass. One reason was ventricular fibrillation
when guide wire passed the PmVSD, another was device dislocation, and
others were the guide wire cannot pass through the PmVSD.
Conclusions:PmVSDs closure using a concentric occluder via a left
parasternal ultra-minimal trans intercostal incision under TEE guidance
is feasible, safe, and effective in children. This approach can be
considered as an alternative treatment to open-heart surgery for
restrictive PmVSDs.%
\end{abstract}%



\sloppy


\textbf{Introduction}

Ventricular septal defect (VSD) is a common congenital heart disease in
children, and most VSDs are perimembranous ventricular septal defects
(PmVSDs).

Traditionally, PmVSDs are surgically repaired under direct visualization
with cardiopulmonary bypass. Although this surgery is effective, it is
associated with significant trauma and slow postoperative recovery.Blood
transfusion is necessary in the cardiopulmonary bypass approach.

Alternatively, the percutaneous closure of a PmVSD has the advantages of
no blood transfusion, minimal trauma and rapid
recovery\textsuperscript{{[}1,2{]}} . But it is associated with exposure
of radiation and allergy to contrast agent\textsuperscript{{[}3,4{]}}.
Another disadvantage of the percutaneous closure technique is that it is
a complicated approach requiring an arteriovenous guidewire loop; this
procedure cannot be performed in patients with vascular access problems.

In recent years, PmVSDs closure via transthoracic minimally invasive
incision under transesophageal echocardiography(TEE) guidance has
attracted the attention of many
scholars\textsuperscript{{[}5-10{]}.}This approach does not require
cardiopulmonary bypass and radiation; it has the advantages of a short
delivery path and no restriction on weight or vascular access. It is
particularly advantageous for children patients who cannot be treated
with percutaneous catheter closure or patients who cannot tolerate
surgery and cardiopulmonary bypass. However, this surgical method
requires the sternum to be transected, which easily causes postoperative
bleeding, pain, and pectus excavatum\textsuperscript{{[}11{]}}.
Moreover, the incision length can reach approximately 2-3 cm, which
affects appearance. Therefore, the procedure cannot be considered as
ideal in terms of minimally invasive surgery.

Based on the minimally invasive transthoracic closures of nearly 1000
patients, our team modified this surgical incision as follows: a less
than 1cm trans intercostal incision in the left sternal margin. Via an
ultra-minimal trans intercostal incision and a pericardium hanging
technique, PmVSDs had been successfully occluded using the concentric
occluder devices under TEE guidance. In this study, we aimed to
investigate the safety, feasibility and availability of this new
surgical approach in children.

\textbf{Material and methods}

\textbf{Patient inclusion}

A total of 131 children who underwent PmVSD closure via a left
parasternal ultra-minimal intercostal incision between January 2015 to
January 2019 were included in this study. The children patients were
diagnosed with restrictive PmVSD based on clinical signs, transthoracic
echocardiography (TTE), electrocardiograms and X-rays.

The inclusion criteria were as follows: no obvious reduction of the size
of PmVSD,slow weight gain and loud heart murmurs; no or mild tricuspid
regurgitation(TR) without valvular heart disease; the distance between
the PmVSD upper rim and the aortic valve larger than 2 mm. The exclusion
criteria were as follows: non-restrictive VSD; malalignment-type VSD;
valve abnormality that require surgical repair; severe pulmonary
hypertension and other heart diseases; other surgical contraindications.
Informed consent was obtained from all the guardians of the patients.

\textbf{Surgical procedures}

\textbf{Device selection}

Final operation plan of PmVSD was chosen according to the TEE results of
the patient after anesthesia in the operating room (Fig. 3A). The size,
location, morphology, and surrounding tissue of PmVSD were
comprehensively evaluated. For PmVSD with AMS, the diameter, number and
direction of the defect in the AMS and the distance between the defects
were seriously analyzed. Simultaneously, the left ventricular side
diameter of AMS was carefully measured. A proper concentric occluder
device size was chosen according to the diameter of the VSD by TEE
measure. Usually, the waist sizes of devices were 0.5-1.5 mm larger than
the VSD maximum diameters. For the patients who had multistream (more
than or equal to 2) PmVSDs in the AMS, the occluder was selected
according to the specific circumstances such as the multistream maximum
distance and the left ventricular side diameter of AMS.

\textbf{Device and delivery system}

The closure device and delivery system used in this study was a domestic
concentric occluder (Shanghai Shape Memory Alloy Co., Ltd., Shanghai,
China, and Shanghai Push Medical Device Technology Co., Ltd., Shanghai,
China). The minimum size of the occluder was 4 mm. Both disks of the
concentric occluder have a diameter of 2 mm larger than that of the
waist (Fig. 1). The waist is 3.5-4.5 mm in height. The entire delivery
system consisted of a trocar, a guidewire, a delivery cable, a short
loading sheath, a long delivery sheath and a dilator.

Before using, the selected concentric occluder must be immersed in
heparin saline, and the delivery system must be washed with heparin
saline. The selected occluder was screwed onto the delivery cable which
had been inserted into the loading sheath. Then, the procedure of smooth
release and withdrawn of the device must be examined prior to the
surgery via the device being pushed forward out the sheath and pulled
back into the sheath. In order to improve the safety of this closure
technique, a device protective suture of 3--0 polypropylene was passed
through the mesh of the right disk near the middle of every device. It
has to be emphasized that the suture cannot entwine the delivery cable
as it was pulled out of the sheath.

\textbf{Procedure}

The patient's body was tilted to the left, and the right side of the
back was slightly elevated. TTE was used to determine the position of
the trans intercostal incision based on the location of VSD and the main
direction of blood flow. A surgical incision [?] 1 cm in length (the
minimum incision in this study was 0.7 cm) was made at the left margin
of sternum of the 3rd to the 5th intercostal spaces, normally the 4th
intercostal space (Fig.2B, Fig.2C).

The subcutaneous soft tissues were opened by blunt dissection without
entering into the pleural cavity. The pericardium was transversely
incised and hung with 4-5 sutures (Fig.2A). TEE was used to determine
the position of the purse-string suture on the right ventricular
surface. With the real-time guidance of TEE, the cardiac surgeon moved
the tweezers in order for the tweezers' head to point toward the PmVSD
and the main direction of blood flow. An optimal angle from the selected
site toward the VSD facilitated the guidewire passing through the VSD.

After heparin (1mg/kg) was administered, a purse-string suture was made
at the position of the tweezers' head under direct visualization. TEE
was placed at a suitable angle for real-time monitoring and guidance. A
punch needle was inserted into the right ventricle through the pouch.
Then, the guidewire was sent to the left ventricle through the PmVSD
(Fig. 3b). The delivery sheath and the dilator were introduced to the
left ventricle over the guidewire after the puncture needle was
withdrawn. If the defect diameter of VSD was too small , surgeon should
expand VSD using the bigger dilator so that the delivery sheath pass
through the PmVSD smoothly. While the top of the sheath was confirmed to
be in the left ventricle, the guidewire and the dilator were withdrawn
(Fig. 3C. The short loading sheath was then connected to the long
delivery sheath. The occluder was pushed to released the left disk from
the sheath (Fig. 3D). According to the shape of PmVSD and AMS, the left
disk was placed on the left ventricular side of PmVSD or pulled all or
partly into the aneurysm. Then, the delivery sheath was withdrawn back
to the right ventricle, and the waist of the device and the right disk
were fully released (Fig. 3E).

TEE was immediately performed. If the device were perfectly released
without complications such as device dislocation, residual shunt,
device-related valve regurgitation (especially the tricuspid valve) and
arrhythmia, the device was inspected repeatedly by a push-pull maneuver
and unscrewed from the delivery cable. Otherwise, the occluder was
adjusted, withdrawn, or replaced if complications arose.

After the occluder was released and unscrewed from the delivery cable,
the protective device suture contributed to the retrieval of the device
through a larger delivery sheath if the device was found to be displaced
by TEE . If all went well, the suture was gently pulled out from the
device and the delivery device was withdrawn. The last steps were to
ligate the purse-string suture and close the incision in~layers
(Fig.~3).

ECG monitor was used to monitor heart rhythm and blood pressure during
the operation. During the surgery, care should be taken in monitoring
heart rhythm, blood pressure, oxygen saturation, blood gas analysis and
airway management. If these indications are abnormal, the procedure
should be discontinued and should even be cancelled.

\textbf{Follow-up}

All patients were followed up. TTE, electrocardiograms, X-rays and blood
tests were used to assess surgical outcomes. The follow-up exams
assessed heart function, heart rhythm, occluder placement, residual
shunt, valve regurgitation, infective endocarditis, thrombus and
pericardial effusion.

\textbf{Results}

126 patients were successfully operated by an ultra-minimal trans
intercostal device closure in all 131 cases. Operation success rate is
96.18\%.

13 patients with PmVSD had aneurysm of membranous septum (AMS). Single
stream PmVSDs, which with or without AMS, were found in 118 cases.
Multistream (more than or equal to 2) PmVSDs with AMS were found in
eleven cases. All of them were closed using one concentric occluder.
There was a mild residual shunt with a diameter of 1.5 mm and a flowing
velocity of 2.0 m/s beside the amplatzer occluder after the surgery, and
it had self healed during the 5-month follow-up period. 9 cases of mild
pericardial effusion was found after the operation and all disappeared
during the 3-month follow-up period. Three cases had a trasient
postoperative hyperpyrexia and returned to normal after treatment. The
degree of TR did not aggravate after surgery. The patients with
successful surgery had good cardiac function. No blood transfusions,
serious arrhythmias or death occurred. Neither did dislocated devices,
residual shunt or device-related valve regurgitation.

5 patients transferred to ventricular septal defect repair operation
under direct visualization with a cardiopulmonary bypass, and the
operations were smooth and the follow-up were normal. One patient was a
fat kid of 63-kg-weight and129-month-old. The surgeon pulled on
leftwards the heart more than 3cm to find the precise position of the
purse-string suture. Ventricular fibrillation occured when guide wire
passed the PmVSD. Another child patient was a 39-month-old and
15-kg-weight boy with large PmVSD of 7.7 mm size. The surgeon tried to
close the large PmVSD with 8mm and 9mm large device, but the devices was
translocated. The procedure was not performed again using larger device
considering his age. Others were the guide wire cannot pass through the
PmVSD, so the surgeons can only performed VSD repair under
cardiopulmonary bypass.

All patients were followed for a perid ranging from18 months to 24
months. Follow-up examinations showed good placement of the occluder,
good heart function, no residual shunts, no arrhythmia, no infective
endocarditis and no thrombus. Device-related valve regurgitation were
not found.

\textbf{Discussion}

Our team modified a novel approach of PmVSD closure via ultra-minimal
trans intercostal incision. Compared with the minimally invasive
inferior sternotomy approach, the operation trauma of novel approach is
much less ([?]1 cm). This novel surgical incision avoids the need for a
sternal incision and blood transfusion. The pericardium hanging
technique replaced the tissue retractor devices for exposure that can
avoid injury to the ribs and the intercostal
tissue\textsuperscript{{[}12{]}}. After the incision healing, it does
not affect the appearance and the postoperative mental health of
patients. By using ultra-minimal skin incisions and transintercostal
incision , surgical trauma can be greatly reduced, Particularly in the
pediatric population.

Compared with the transcatheter PmVSD closure approach, the novel
approach is simpler. This approach has a short operating pathway of and
does not require the establishment of an arteriovenous guidewire
loop\textsuperscript{{[}12{]}}, which can prevent inferior vena cava and
aorta injure. It provides an angle point toward the PmVSD,and the
guidewire is easier to pass through VSD. Moreover, clear TEE
image\textsuperscript{{[}12,13{]}} can accurately and effectively assess
PmVSD and clearly show the guide wire, sheath and occluder to provide
real-time guidance that enables cardiac surgeons to operate smoothly.

The positions of the intercostal incision and the purse-string suture
should be selected very carefully and accurately because ultra-minimal
incisions ([?]1 cm) limit the range over which the guidewire and sheath
can move. Our team used both TTE and TEE to select accurately location
of the incision and that of the purse-string suture, according to the
location of the PmVSDs and the main direction of blood flow. First, TTE
was used to determine the position of the incision. The PmVSDs is often
located behind the sternum. So the incision should be located next to
the left sternum, simultaneously, the blood vessels and nerve tissues
were avoided. Then, TEE was used to determine the purse-string position.
Under TEE guidance, the surgeon gently pulled the heart to the left, and
found out the position of purse-string suture through tweezer being
moved on the right ventricular anterior wall. It should be noted that
the surgeons should clamp gently the right ventricular surface using the
tweezers to avoid damage to the right ventricular surface when the
position of the purse-string suture is determined. When the tweezers was
pointed toward the orifice of the VSD or the direction of blood flow,
the position can be fine-tuned to ensure that the puncture site and
PmVSD had the best entry angle and lay the foundation for the wire to
smoothly pass through the VSD. The correct location of the incision and
the purse-string suture can greatly increase the success rate of device
closure and can reduce the operative time and surgical risk.

When multiple defects of AMS are very close together, it is easier to
occlude the PmVSD completely through unfolded disk. Nevertheless, when
the defects are divergent, PmVSD closure is a major
challenge\textsuperscript{{[}14{]}}. Devendran
etc.\textsuperscript{{[}15{]}} considered that closure of multistream
PmVSDs using a single device was not possible when the defects were far
apart. But there were a few cases of success in our study. For example,
we had one case with the two defects in the AMS far from each other. One
defect was near the tricuspid septal leaflet, the other was close to the
interventricular septum. The entry of guide wire into the VSD was
extremely difficult. The guidewire and sheath could not enter the defect
near the tricuspid septal leaflet. And only the defect close to the
interventricular septum could be selected. If the guide wire is
completely aligned with the direction of blood flow, entering the AMS is
not difficult, but turning the guidewire 90 degrees to enter the left
ventricle is very difficult. In this case, the purse-string can be
positioned at a certain angle to reduce the difficulty for the guidewire
to enter the left ventricle after it enters the AMS.

The reasons such as the defects of the multistream PmVSD being
divergent, retrosternal PmVSD forming an Angle with the incision, led to
that the procedure durations of PmVSDs closure via an ultra-minimal
trans intercostal incision were longer than thats of DCVSDs
closure\textsuperscript{{[}12{]}}. So, the cooperation of the team and
the cumulation of experience is more important. All members of the team
should remain aware of the patient's condition and know how to deal with
the situation changed during surgery. The surgeons and the
echocardiologist should work closely to make the operation smoothly.
Skillful surgical technique and proficient TEE guidance, wicth can
reduce the duration of surgery, are very important for a successful
procedure.

For AMS with a single stream, the left disk of the occluder can be all
or partly pulled into the aneurysm to close PmVSD easily. However, the
basilar part of the multistream PmVSD need be occluded through the left
disk of the occluder be anchored on the left ventricle side of PmVSD.
The surgical experience is summarized as follows. First, it is important
to assess carefully PmVSD through TEE before select the appropriate
occluders. Second, this challenge requires the surgeons and
echocardiologist to have great patience and tacit cooperation.
Third,~when the guidewire enters the AMS, the surgeon can gently pull on
the heart to reduce the angle and make it easier to allow the guidewire
to enter the left ventricle. Fourth, a mild residual shunt ([?] 2
mm)\textsuperscript{{[}16{]}}and low flowing velocity do not
significantly impact the patient and can heal by itself.

Scholars had reported that the estimated incidence of arrhythmia,
especially complete atrioventricular block, was 5.7--22 \% after
transcatheter device closure\textsuperscript{{[}17,18{]}}.The use of an
oversized occluder is one of the main reasons for atrioventricular
conduction block and other arrhythmias. Therefore, the size of occluders
should be chosen as small as possible on the premise of success closure
in order to avoid arrhythmia. In this study, the size of the device is
approximately 1 (0.5-1.5 ) mm larger than the PmVSD diameter, and no
obvious arrhythmia or complete atrioventricular block occurred.

The complications such as pericardial effusion, pleural effusion and
hyperpyrexia contributed to increased postoperative hospital stay. These
patients were not discharged until they had normal temperature and
pericardial and pleural effusion improved.

Among them, 2 patients transferred to ventricular septal defect repair
operation under direct visualization with a cardiopulmonary bypass. One
patient was overweight, so the surgeon must pull the heart leftwards
more than 3cm to locate the precise position of the purse-string suture.
Ventricular fibrillation occured when guide wire passed the PmVSD, which
may be associated with excessive traction. The other patient had so
large PmVSD that the device dislocated. The trans intercostal
ultra-minimal incision is difficult to set up cardiopulmonary bypass
quickly. PmVSD repair under visualization needs a new mid-sternum
incision. After surgical repair, the presence of both a long and a short
incision may affect the patient's appearance. We suggested that large
PmVSD or obese children's PmVSD should be occluded via the minimally
invasive inferior sternotomy approach. If closure fails, the incision
can be extended.

\textbf{limitations}

There are several limitations of this study. It is a single center
study. The age range of the children in this study was 10 months to 127
months; patients in other age groups are not included. A shorter-term
follow-up was performed for 18-24 months. Our team will continue to
expand the sample size and extend the follow-up time to provide more
reliable and relevant information on this surgical method.

\textbf{Conclusions}

In conclusion,~ PmVSD closure via an ultra-minimal trans intercostal
incision under TEE guidance is effective, feasible, safe and simple
approach with less trauma. Surgical complications are rare. Therefore,
promoting the application of this procedure in restrictive PmVSD is
worthwhile.

\textbf{Conflict of interest}

We declare that we have no conflicts of interest.

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\textbf{Take-home figure}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image1/image1}

\end{center}
\end{figure}

\textbf{One-Sentence Summary}

PmVSD was occluded using a concentric occluder device via a left
parasternal ultra-minimal trans intercostal incision([?]1 cm) under TEE
guidance in children, and the length of surgical scar was similar to the
diameter of gel ink pen at~one~year.

\textbf{Figure 1}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image2/image2}

\end{center}
\end{figure}

The concentric occluder was screwed onto the delivery cable, which
traveled to the short loading sheath. Both disks of the concentric
occluder have a diameter of 2 mm larger than that of the waist.

\textbf{Figure2}

\textbf{A}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image3/image3}

\end{center}
\end{figure}

B\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image4/image4}

\end{center}
\end{figure}

C\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image5/image5}

\end{center}
\end{figure}

A: Hanging the pericardium with four sutures to expose the heart.

B: A 1.0 cm ultra-minimal intercostal incision used in children.

C: The length of surgical scar was compared with the diameter of gel ink
pen ~at~one~year.

\textbf{Figure 3}

\textbf{A}\selectlanguage{english}
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B\selectlanguage{english}
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C\selectlanguage{english}
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D\selectlanguage{english}
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E\selectlanguage{english}
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Procedures of PmVSD closure via ultra-minimal intercostal incision under
the TEE guidance

A: A PmVSD (arrow) was found in the large artery short axial view on
TEE.

B: The guidewire (arrow) was sent to the left ventricle through the
PmVSD.

C: The delivery sheath and the dilator were introduced to the left
ventricle over the guidewire. While the top of the sheath was confirmed
to be in the left ventricle, the guidewire and the dilator were
withdrawn and only the delivery sheath (arrow) was keep.

D: The short loading sheath loaded with the device was then connected to
the long delivery sheath. The device was pushed to released the left
disk (arrow) from the sheath.

E: The concentric occluder was placed in a proper position without
residual shunt and influence on valve.

PmVSD: Perimembranous ventricular septal defect; TV: Tricuspid valve;
LA: Left atrium;

LV: left ventricle;RV: Right atrium;AO: Aorta\selectlanguage{english}
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