1 INTRODUCTION
Childhood cancer burden is attracting global attention, with nearly 90%
of those children from low- and middle-income
countries.1 Central venous access devices are
necessary for children with malignancy requiring long-term intravenous
therapy and routine laboratory tests.2,3 Nowadays,
totally implantable Venous access ports (TIVAPs) are the preferred
choice because of their higher cost-effectiveness, fewer complications
and aesthetic advantages compared with peripherally inserted central
catheters (PICCs).4,5
Although there is no consensus regarding venous access approach,
ultrasound-guided internal jugular vein (IJV)
puncture
and subclavian vein (SCV) access
based on anatomical landmark for TIVAPs implantation are the most common
methods in pediatric population.6,7 However, these two
methods have certain drawbacks. The IJV approach has disadvantages of
higher puncture point, smaller catheter radian, risk of misplacement,
catheter bending and blockage, and patient discomfort due to longer
catheter trajectory,7 whereas the SCV access is prone
to be kinking such as pinch-off syndrome and has a relatively lower
first-attempt success rate.8 However, since the
initial report of ultrasound-guided brachiocephalic vein (BCV) approach
in the supraclavicular region by Breschan et al.9 in
2011, it has been widely used in adults,10children,11-13 infants,14,15 and
even premature infants16-18 for central venous
catheters (CVCs) insertion procedure. And this approach is associated
with a higher puncturing success rate, shorter cannulation
time,10,19 and lower complication rate compared with
other approaches.12 As such, Avanzini et
al.11 recommended that BCV approach should be adopted
as the first choice for long-term venous access.
While ultrasound-guided, supraclavicular BCV insertion for TIVAPs
implantation in adults was proven to be safe and
effective.20,21 However, its use in children has not
been reported in the literature. Therefore, the goal of the present
study is to describe our preliminary experience of ultrasound-guided
TIVAPs placement via the right BCV approach for in pediatric patients
with malignancy, aiming to evaluate its technical feasibility, safety
and efficacy in this particular patient population.
2 METHODS
2.1 Study population
Electronic medical records of all pediatric patients who underwent
TIVAPs implantation via ultrasound-guided insertion of the right BCV in
a single institution from July 2018 to June 2021 were retrospectively
reviewed. The study was approved by the institutional ethics committee
(KY21012), and the written informed consent was obtained from all
children’s legal guardians. The surgical decision was confirmed by the
multidisciplinary board according to the expert consensus in China.
Patients within the first year after this novel technique was adopted
were excluded in consideration of the operator learning curve. Patients
with coagulopathy (e.g. blood transfusions were performed until
platelets value larger than 50 × 109/L) was corrected
preoperatively and surgical contraindications (e.g. definite infection
in the surgical or other sites) were excluded. There is only one brand
of TIVAP devices (Babyport, 4433742, 4.5 F; B.Braun, Inc.,
Ile-de-France, France) in our study.
2.2 Predefined surgical protocol
2.2.1 Protocol for preoperative
preparation
All surgeries were performed by two attending interventional surgeons
under general anesthesia composed of muscle relaxation, tracheal
intubation and positive pressure ventilation in the hybrid operating
room. Both surgeons had experience
with hundreds of TIVAPs
implantation by ultrasound-guided BCV cannulations in adult patients.
The children were placed in supine position on the operating table, with
the head tilted to the opposite side, the neck and shoulder properly
bolstered, and the supraclavicular area and chest wall in the surgical
side fully exposed. The operators stood at the right side of the
patients, taking the right BCV approach as an example. The ultrasound
machine was placed on the left side of the child to optimize
visualization of the screen.
2.2.2 Protocol for BCV approach
A portable ultrasound device with a 13-6 MHz linear-array transducer
(M-Turbo; Sonosite, Inc., Bothell, WA, USA) was implemented to identify
the BCV. Here we take the right-side access for example. Firstly, a
sonographic cross-sectional view of the IJV was obtained by placing the
ultrasonic probe perpendicular to the lower neck. Then, the ultrasound
probe was moved caudally along the IJV until the confluence of the IJV
and the ipsilateral SCV was displayed, where the BCV takes off. Finally,
the optimal longitudinal view of the BCV was displayed by turning the
probe slightly medially and caudally behind the clavicle. Using in-plane
method, the needle was advanced from lateral to medial and into the
target vessel under the real-time ultrasonographic surveillance
(Figure 1A). In addition, the needle advancement was stopped immediately
if the needle was no longer visualized on ultrasound.
2.2.3 Protocol for surgical
procedure
Under sterile steps, the right BCV was punctured with a 21G needle after
its optimum longitudinal view achieved on ultrasound screen (Figure 1A).
If venous blood could be smoothly aspirated, a 0.018-inch-diameter
(0.46mm) J shape guide wire was
introduced. The guide wire was checked in the superior vena cava under
fluoroscopy, and a 3-mm-length incision was made in the puncture site. A
peelable sheath was sent into the vessel along the guide wire, and then
the catheter was advanced through the sheath following the guide wire
being removed. A transverse incision approximately 2-cm-length and a
pocket sized to exactly accommodate the port reservoir was created on
the right upper chest wall one to two fingers width below the clavicle.
Accordingly, the catheter was guided to the pocket from the
supraclavicular exit through a tunnel needle, and its tip was adjusted
to be positioned at the cavoatrial junction under fluoroscopy
(Figure 1B). Subsequently, the catheter was cut and connected to the
port body, which was then placed into the pocket after confirming no
obstruction and leakage via flushing. Finally, the infraclavicular
incision was sutured with a 5-0 absorbable sutures, followed by blood
withdrawal and fluid infusion tested again before the incision was
covered with sterile dressings (Figure 1C).
2.3 Data collection and follow-up
Research data was obtained from the medical record reviewing and
included preprocedural variables (e.g. basic demographics, indication
for implantation, certain blood examination); procedural information
(e.g. number of attempts, operative time, intraoperative complications);
and procedural outcome data (e.g. postoperative complications, timing
and reasons for TIVAP removal). Based on the time of occurrence,
postoperative complications were divided into early (within 30 days) and
late complications (after 30 days). Furthermore, complications were
categorized as wound complications (e.g. wound dehiscence, delayed
incision healing), mechanical complications (e.g. catheter dysfunction,
catheter malposition/ fracture); and infectious complications (e.g.
local infection, catheter-related bloodstream infection [CRBSI]).
Operation time is calculated from beginning of puncture to incision
closure. Catheter dysfunction was defined as inability of blood
withdrawal with or without difficulty of fluid injection. The deadline
of clinical surveillance was December 31, 2021.
2.4 Statistical analysis
Statistical analyses were performed through the SPSS software (version
25.0). All variables were tested with the Shapiro-Wilk test for
normality and verified for completeness. Descriptive statistics were
reported as mean ± standard deviation (range) , median (interquartile
range [IQR]) and the frequency (%).
3 RESULTS
3.1 Study population
A total of 35 children who underwent TIVAPs placement were identified,
with 21 males and 14 females. The patient median age at the time of
surgery was 36 months (IQR: 18, 53 months), ranging from 2 to 115
months. The weight at procedure ranged from 6.5 to 38.0 kg with a median
of 15.0 kg (IQR: 11.5, 17.0 kg), and only four patients were less than
10.0 kg. Intravenous chemotherapy was the only indication for TIVAPs
implantation in the present study population. Underlying diseases were
acute lymphoblastic leukemia (25/35, 71.4%), acute non-lymphocytic
leukemia (5/35, 17.1%), hepatoblastoma (2/35, 5.7%), and
retinoblastoma (2/35, 5.7%). The platelets count was elevated from the
median of 102 × 109/L (IQR: 40, 233 ×
109/L) on admission to that of 137 ×
109/L (IQR: 70, 277 × 109/L) before
surgery, and among them ten children whose platelets value less than 50
× 109/L received once or multiple blood transfusions. (Table 1)
3.2 Perioperative results
All of the 35 children’s TIVAP implantations successfully performed via
right BCV approach with a success rate of 100%. Vascular access was
successful by first attempt in 32 patients (91.42%), by second attempt
in two cases (5.71%), and by the third attempt in one child (2.86%).
There was no intraoperative conversion to the ipsilateral IJV or the
contralateral BCV approach. The average time of operation was 44.63 ±
6.41 mins (range, 34-62 mins), and the fluoroscopy time ranged from 7 to
27 seconds with a median of 10 seconds (IQR: 8, 13 seconds). No
procedural related complications (e.g. pneumothorax, inadvertent artery
puncture) occurred. Every child began chemotherapy within 3 days after
TIVAPs placement, with a median interval time from the end of surgery to
initial port access of 1 day (IQR: 1, 2 days). (Table 2)
3.3 Follow-up outcomes
Three patients experienced a total of four complications, including two
cases of local hematoma and two episodes of catheter dysfunction. The
postoperative complication rate was 11.43%, equivalently a rate of 0.20
complications per 1000 catheter-days across the cumulative 19,723
catheter-days during the TIVAP carrying period with a mean time of
563.51 ± 208.47 days (range, 193-1014 days). Two cases of local
subcutaneous hematoma were self-limited after conservative treatment
with local compression and dressing changes. One of these hematomas
occurred in a 2-month-old, 6.3-kg-weight infant and lasted for nearly
two months (Figure 2). Both cases of catheter dysfunction were
considered as intraluminal occlusion, presented as inability of blood
aspiration and fluid injection. Catheter patency was restored with
thrombolytic therapy using urokinase (5,000 IU/ mL) and positive
pressure tube sealing for 30-60 minutes. No other complications such as
wound dehiscence, catheter-related thrombosis (CRT), catheter
malposition or fracture, surgical site infection, CRBSI, pinch-off
syndrome and drug extravasation were observed. None of the 35 children
required premature removal of the devices. A total of 11 patients
(31.4%) had TIVAP removed due to the end of chemotherapy, and the
remaining were still in use (Table 2).