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ORIGINAL ARTICLE
European Journal of Cardio-Thoracic Surgery 52 (2017) 805–809
doi:10.1093/ejcts/ezx269 Advance Access publication 27 July 2017
Cite this article as: Yu J, Ma L, Ye J, Zhang Z, Li J, Yu J et al. Doubly committed ventricular septal defect closure using eccentric occluder via ultraminimal incision. Eur J
Cardiothorac Surg 2017;52:805–9.
Doubly committed ventricular septal defect closure using
eccentric occluder via ultraminimal incision
Jin Yua, Lianglong Mab, Jingjing Yea, Zewei Zhangb,*, Jianhua Lib, Jiangen Yub and Guoping Jianga
a
b
Department of Ultrasound Diagnosis, Children’s Hospital, Zhejiang University School of Medicine, Hangzhou, China
Department of Cardiothoracic Surgery, Children’s Hospital, Zhejiang University School of Medicine, Children’s Hospital, Hangzhou, China
* Corresponding author. Department of Cardiothoracic Surgery, Children’s Hospital, Zhejiang University School of Medicine, Hangzhou 310000, China.
Tel: +86-13957101598; e-mail: zeweiz@zju.edu.cn (Z. Zhang).
Received 18 December 2016; received in revised form 13 June 2017; accepted 28 June 2017
Abstract
OBJECTIVES: This study aimed to investigate the safety, feasibility and availability of doubly committed ventricular septal defect (DCVSD)
closure via an ultraminimal intercostal incision under the guidance of transoesophageal echocardiography in children.
RESULTS: All 35 children had complete closures with an operation success rate of 100%. The average size of DCVSDs was 3.50 ± 0.79
(range 2.2–5.0) mm, and the average device size was 5 ± 2 (range 4–9) mm. The average operation duration was 45.42 ± 11.77 (range
25–70) min, and the average hospital stay was 8 ± 2 (range 7–16) days. The median follow-up period was 17 months (range 6 months–
2.5 years). Pre-existing aortic regurgitation disappeared after surgery in 1 patient and remained the same in 4 patients. No other complications were found during the operation or during follow-up.
CONCLUSIONS: Under transoesophageal echocardiography guidance, DCVSD closure using an eccentric occluder via an ultraminimal
intercostal incision is feasible, safe and effective in children. The use of this approach is recommended.
Keywords: Congenital defects • Echocardiography/transoesophageal • Minimally invasive • Closure
INTRODUCTION
The spontaneous closure of a doubly committed ventricular septal defect (DCVSD) is very rare [1]. DCVSDs are prone to develop
aortic valve prolapse (AoVP) or aortic regurgitation (AR) due to a
lack of support for the right aortic leaflet [2] and shock resulting
from high blood flow [3]. Therefore, DCVSDs should be closed as
soon as possible [1].
Conventional DCVSD repair under direct visualization with a
cardiopulmonary bypass is effective but causes considerable
trauma. The percutaneous closure of a perimembranous ventricular septal defect (VSD) has the advantages of causing less trauma
and resulting in a good outcome and quick recovery [4, 5].
However, the percutaneous closure of a DCVSD is difficult to perform [6] and has a high failure rate [2]. Transcatheter closure is a
complicated approach requiring an arterio-venous guide wire
loop; this procedure cannot be performed in patients with low
body weight or vascular access problems. Another disadvantage of
the percutaneous closure technique is that it exposes patients to
radiation [7–10]. Recently, the minimally transthoracic closure of
VSDs under the guidance of transoesophageal echocardiography
(TOE) has been developed [11–16] to treat DCVSDs [17–19]; compared with the percutaneous approach, this procedure has the advantages of a short delivery path, no radiation injury and no
restriction on weight or vascular access. However, the approach
requires a sternum incision, which can easily lead to bleeding,
pain and pectus excavatum [15]. The incision length averages 3–
4 cm, and scarring of the incision affects patients’ cosmetic appearance. Moreover, DCVSDs are located just below the aortic and
pulmonary valves [18], and the lower sternal incision is separated
from the DCVSD. Technically, this approach is not considered an
ideal minimally invasive surgery.
On the basis of the minimally invasive transthoracic closures
of more than 900 patients, we modified the approach using a
left parasternal ultraminimal intercostal incision. With an
ultraminimal incision and a pericardium hanging technique,
DCVSD closure using an eccentric occluder has been successfully
implemented in children. In this study, we aimed to investigate
the safety, feasibility and availability of this new surgical
approach.
C The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
V
CONGENITAL
METHODS: From August 2014 to August 2016, 35 children with DCVSDs (<_5 mm in diameter) were enrolled in this study. A left parasternal
ultraminimal intercostal incision (<_1 cm) and a pericardium hanging technique were employed without sternal incision. DCVSDs were
closed through a short delivery sheath assembled with an eccentric occluder device. Transoesophageal echocardiography was used to
guide and monitor the entire procedure. All patients were followed up.
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J. Yu et al. / European Journal of Cardio-Thoracic Surgery
MATERIALS AND METHODS
Patient inclusion
A total of 35 children who underwent DCVSD closure via an
ultraminimal intercostal incision between August 2014 and
August 2016 were included in this study. Transthoracic echocardiography (TTE), electrocardiograms and X-rays were performed
before surgery. TTE was used to measure DCVSD size and assess
the condition of the aortic and pulmonary valves. Five patients
had mild AR in this study. Informed consent was obtained from
all the guardians of the patients.
The inclusion criteria were as follows: DCVSD located at the
12:00 to 1:30 o’clock position in the parasternal short-axis view
on TTE, diameter <_5 mm, no AR and mild AoVP and AR with a
perfect closed point. The exclusion criteria were as follows:
DCVSD with a diameter >5 mm, moderate-to-severe AoVP or AR,
severe pulmonary hypertension and other heart diseases; other
surgical contraindications.
Surgical procedures
Device selection. After the children were anaesthetized in the
operating room, TOE was performed to measure the size of the
DCVSD and to assess the integrity of the aortic and pulmonary
valves. A proper eccentric occluder was chosen according to the
TOE examination results. Normally, the size of the device is approximately 2 mm larger than the maximum diameter of the defect.
Device and delivery system.
The closure device and delivery
system used in this study was a domestic eccentric occluder
(Shanghai Shape Memory Alloy Co., Ltd, Shanghai, China). The
left disc of the eccentric occluder exceeds the connecting waist
by 0 mm in its superior aspect and by 4.0 mm in its inferior aspect (mark). The right disc is 2 mm larger than the waist in both
parts of the device. The waist is 3.5–4.0 mm in diameter. The delivery system is mainly composed of a long delivery sheath, a
short loading sheath and a delivery cable (Fig. 1). Prior to use, the
selected eccentric occluder must be soaked in heparin saline,
and the delivery system must be washed with heparin saline. The
occluder was screwed onto the delivery cable to be inserted into
the loading sheath. Then, the device must be examined prior to
the operation by pulling back and pushing forward to release it
from the sheath. A protective suture of 3-0 polypropylene passing through the mesh of the right disc near the middle was
added to the device.
Procedure.
TTE was used to determine the position of the
ultraminimal intercostal incision based on the location of the
DCVSD and the direction of blood flow. The incision was commonly made in the left sternal margin at the third intercostal
space. An incision less than 1 cm in length (the smallest incision
in this study was 0.7 cm) was made. Superficial tissues were
opened with blunt dissection without entering into the pleural
cavity. The pericardium was incised transversely and hung with
4–5 sutures (Fig. 2). With the real-time guidance of TOE, the position of the purse-string suture on the right ventricular surface
was determined using tweezers under direct visualization. When
the tweezers’ head was vertically pointed towards the DCVSD, a
purse-string suture was made at the position of the tweezers’
Figure 1: (A) From top to bottom, the delivery system includes a delivery cable,
a short loading sheath, a long delivery sheath and a dilator. (B) The eccentric
occluder was screwed onto the delivery cable, which travelled to the short
loading sheath. The left arrow indicates the spot where the device-protective
suture was passed through the mesh of the right disc; the middle arrow indicates where the device-protective suture was placed in the short loading sheath
and the right arrow indicates where the device-protective suture was pulled
out of the short loading sheath. (C) The eccentric occluder was pulled into the
short loading sheath to show only a mark (large arrow). The small arrow indicates where the device-protective suture was pulled out of the sheath.
head. An optimal angle from the selected site towards the VSD
facilitated the insertion of the guide wire through the VSD.
After heparin (0.5 mg/kg) was administered, a punch needle
was inserted into the right ventricle. Then, the guide wire was inserted into the DCVSD. The punch needle was withdrawn, and
the delivery sheath was introduced to the left ventricle over the
guide wire. Although the tip of the sheath was confirmed to be
in the left ventricle, the surgeon withdrew the guide wire and the
dilator. The short loading sheath was then connected to the long
delivery sheath. TOE was placed at approximately 110 (in the
left ventricular long-axis view) for real-time monitoring and guidance, whereas the surgeon pushed the occluder and released the
left disc. It is important to verify that the mark appears clearly
distant from the aortic valve to avoid interfering with the movement of the valve. If the device was not in the right position, the
occluder could be gently rotated clockwise through the delivery
cable and then adjusted to a precise location until no AR exists.
Then, the sheath was withdrawn further back towards the right
ventricle, and the waist of the device and the right disc were
completely released (Fig. 3).
TOE was performed. The occluder was adjusted, withdrawn or
replaced if complications such as device dislocation, residual
J. Yu et al. / European Journal of Cardio-Thoracic Surgery
807
shunt, device-related aortic or pulmonary regurgitation or outflow tract obstruction were found. The device was inspected repeatedly by a push–pull manoeuvre and released only when it
was in its proper position with no complications.
After the occluder was released, the protective device suture
aided in the retrieval of the device through a larger delivery
sheath if the device was found to be displaced by TOE [2]. If conditions were normal, the suture could be gently pulled out from
the device. Then, the delivery device was removed, and the
R venous
purse-string suture was ligated. A percutaneous ArrowV
catheter was placed in the pericardial cavity for drainage; 3 holes
one-third the size of the catheter diameter were made on the
intrapericardium segment of the catheter. The incision was
closed in layers.
During the operation, patients were closely monitored for
heart rate, blood pressure, oxygen saturation, blood gas analysis
and airway management; monitoring was comparable to that accompanying any open-heart surgery. The procedure should be
discontinued if these indications were abnormal. If severe complications occur, the procedure should be immediately converted
to surgical repair under cardiopulmonary bypass.
Key points.
CONGENITAL
Figure 2: (A) Hanging the pericardium with 4 sutures to expose the heart.
(B) A 1.0-cm ultraminimal intercostal incision was used in children.
When planning to close DCVSDs via ultraminimal
intercostal incisions under TOE guidance, the following issues
should be addressed. First, to ensure that the operation is performed smoothly, the ultrasound doctor and the surgeons should
Figure 3: DCVSD closure using an eccentric occluder via an ultraminimal intercostal incision under the guidance of transoesophageal echocardiography (TOE).
(A) A small DCVSD (arrow) was found in the left ventricular long-axis view on TOE. (B) The tweezers’ head (arrow) was pointed towards the DCVSD. (C) The delivery
sheath (arrow) loaded with the device passed through the defect. (D) The mark on the left disc shows its separation from the aortic valve. The eccentric occluder was
placed into a proper position without residual shunt and valve regurgitation. AO: aortic; AV: aortic valve; DCVSD: doubly committed ventricular septal defect; LV: left
ventricle; PV: pulmonary valve; RV: right ventricle.
808
J. Yu et al. / European Journal of Cardio-Thoracic Surgery
work closely as a team; all members of the team should know
what is happening and notify each other immediately when the
situation changes. Second, skilful surgical technique is important
for a successful procedure. The accumulation of experience is
very important. Third, preoperative TOE must be performed
carefully. According to the inclusion criteria, patients will be reevaluated by TOE in the operating room, and the doctors will
discuss their choice of an optimal closure device. A large
occluder might cause valve damage, and a small occluder could
cause device dislocation or a residual shunt. Fourth, the positions
of the intercostal incision and the purse-string suture should be
selected very carefully, because an ultrasmall incision could limit
the range over which the guide wire and sheath could move.
Using both TTE and TOE, the correct location of the incision and
the purse-string suture can be selected accurately, which will
greatly increase the success rate of device closure and reduce the
operative duration and risk of surgery. Fifth, tweezers should not
be used to repetitively clamp to avoid damage to the right ventricular surface when the position of the purse-string suture is
determined using the tweezers. Sixth, the device-protective suture should be used for all patients. The suture cannot entwine
the delivery cable as it is pulled out of the sheath, thereby improving the safety of this technique. Seventh, the incision should
not be made too close to the left sternal margin to avoid injury
to the left internal mammary artery [2].
Follow-up
All patients were followed up. TTE, electrocardiograms, X-rays
and blood tests were used to assess surgical outcomes. The
follow-up examinations assessed heart function, heart rhythm,
occluder placement, residual shunt, valve regurgitation, infective
endocarditis, thrombus and pericardial effusion.
Statistical analysis
Data on age, weight, DCVSD size and procedure time were normally distributed and were expressed as the mean ± standard deviation and range, as appropriate. Data on device size and length
of hospital stay were non-normally distributed and were expressed as the median ± interquartile range and range, as appropriate. All data were analysed using SPSS 19.0 statistical software.
RESULTS
Clinical data and outcomes for all the 35 patients are listed in
Table 1. All patients had complete closures with an operation success rate of 100%. Correct placement of the device on the first attempt was achieved in 32 (91.43%) patients; in 3 patients, a second
attempt was performed to replace the small device with a bigger
one due to the presence of a residual shunt around the occluder
device. Five patients were diagnosed as having DCVSD with mild
AoVP and AR before the surgery; all operations were performed
smoothly, and no aggravation of AR was found during the operations. Heart function was good in all patients, and no blood
transfusions, serious arrhythmias or death occurred. There were
no dislocated devices, residual shunts, device-related valve regurgitation or outflow tract obstruction during the operation. Mild
pericardial effusion was found in 1 patient after the operation and
disappeared over the course of the 3-month follow-up period.
Table 1: Clinical data and outcomes of the 35 patients
Variables
Values
Gender (female/male)
Age (months)
Weight (kg)
DCVSD size (mm)
Device size (mm)
Procedure duration (min)
Hospital stay (days)
13/22
34.16 ± 16.50 (range 13–72)
14.49 ± 4.07 (range 8–22)
3.50 ± 0.79 (range 2.2–5.0)
5 ± 2 (range 4–9)
46.10 ± 11.61 (range 25–70)
8 ± 2 (range 7–16)
DCVSD: doubly committed ventricular septal defect.
All patients were followed up for a period ranging from
6 months to 2.5 years (median 17 months) after the operation.
Follow-up examinations showed good placement of the occluder,
good heart function, no residual shunts, no arrhythmia, no infective endocarditis and no thrombus. Pre-existing AR disappeared
after surgery in 1 patient and remained the same in 4 patients.
Device-related AR and pulmonary regurgitation were not found.
DISCUSSION
In this study, we used an eccentric occluder to close DCVSDs
(<_5 mm) via ultraminimal intercostal incision under TOE guidance. To the best of our knowledge, this approach is a novel
strategy for the treatment of DCVSD.
Application of an eccentric occluder device enables DCVSD
closure using an occluder via an ultraminimal incision. The eccentric occluder device can avoid the aortic valve and pulmonary
valve trauma caused by the placement of a concentric occluder
[2, 18, 19]. Pointing the superior part of the left disc towards the
aortic valve can prevent impairment of aortic function. The right
disc of the device is separated from the pulmonary valve, because left ventricular pressure is higher than right ventricular
pressure after the VSD is occluded. Therefore, the area contacting
the pulmonary valve is the waist but not the rim of the right disc
of the occluder. The pulmonary annulus is slightly higher than
the aortic annulus [2]. These features greatly decrease the risk of
impairment of the pulmonary valve. Without the aortic and pulmonary rim, the circumferential rim can provide sufficient support to the occluder in small DCVSDs [2]. DCVSDs with a small
teardrop-shaped mild AoVP and mild AR [20] were not considered a contraindication for this procedure [2]. Small DCVSDS
allow for greater shunt velocities and thus greater force pulling
the aortic cusp into the VSD [3]. Over time, the aortic cusp elongates to cause AoVP and AR. After successful DCVSD closure,
AoVP and AR may not be exacerbated because there is no shunt
to interfere with the aortic valve.
Compared with the transcatheter closure approach, the operation duration of the ultraminimal intercostal incision closure approach is shorter [4, 6]. This novel approach has a short delivery
path and does not require the establishment of an arteriovenous guide wire loop through the aorta and the aortic valve.
Moreover, TOE [16] can clearly detect the guide wire, sheath and
occluder to provide real-time guidance that enables cardiovascular surgeons to operate smoothly. The distance from the intercostal incision to the DCVSD is shorter, and the plane of the DCVSD
lies almost perpendicular to that of the remainder of the septum.
J. Yu et al. / European Journal of Cardio-Thoracic Surgery
Limitations
This study is limited by the fact that it is a single-centre study
with a small sample size and a short follow-up period. We reported only 35 patients successfully treated using this approach.
Further studies are required to establish long-term follow-up results in a larger patient population. The age range of the 35 children in this study was 13 months to 72 months; patients in other
age groups must be studied.
CONCLUSION
In conclusion, DCVSD (<_5 mm) closure via an ultraminimal intercostal incision under TOE guidance is effective, feasible, safe and
simple. Surgical complications are rare. Therefore, this approach
can be considered an alternative treatment to open-heart surgery
for selective DCVSDs.
ACKNOWLEDGEMENTS
We thank Zhongyun Zhuang (Shanghai Shape Memory Alloy
Co., Ltd, Shanghai, China), Xianghong Zhang (Children’s
Hospital, Zhejiang University School of Medicine, Hangzhou,
China), Zhuo Shi (Children’s Hospital, Zhejiang University School
of Medicine, Hangzhou, China) and Lili Yang (Children’s
Hospital, Zhejiang University School of Medicine, Hangzhou,
China) for their help with language editing. We thank Lixin
Zhuang (Shanghai Shape Memory Alloy Co., Ltd) for providing
support with the closure device and delivery system illustrations.
Funding
This work was supported by the Education Department of
Zhejiang Province, China [Y201636526].
Conflict of interest: none declared.
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CONGENITAL
Thus, the delivery sheath is more perpendicular to the DCVSD,
resulting in easier and more accurate device positioning [2].
As in the transcatheter procedure, no blood transfusion is necessary in this novel approach.
The ultraminimal intercostal incision (<_1 cm) avoids the need for a
sternal incision and leads to minimal scarring. The use of the pericardium hanging technique instead of retractor devices for exposure
can avoid injury to the ribs and the intercostal tissue.
When an occluder closure fails, the procedure must be converted to an open-heart surgical repair. After surgical repair, the
presence of both a long and a short incision may affect the patient’s appearance.
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