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\begin{document}

\title{Ultrasound-guided totally implantable venous access ports placement via
right brachiocephalic vein in pediatric population: a clinical debut}



\author[1]{Wei Ding}%
\author[2]{Lu Qiu}%
\author[2]{Tianyu Li}%
\author[2]{Weiwei Su}%
\author[3]{Qian Yu}%
\author[4]{Tianshen Hu}%
\author[1]{Chunxin Wang}%
\author[1]{Chen Fan}%
\author[1]{Weidong Wang}%
\affil[1]{Wuxi People's Hospital}%
\affil[2]{Wuxi Children's Hospital}%
\affil[3]{The University of Chicago Medical Center}%
\affil[4]{The University of Texas Southwestern Medical Center}%


\vspace{-1em}



  
  \date{June 13, 2024}


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\selectlanguage{english}
\begin{abstract}
Background and objectives: To investigate the feasibility and safety of
ultrasound-guided totally implantable venous access ports (TIVAPs) via
the right brachiocephalic vein (BCV) in pediatric patients. Methods: A
single institutional retrospective review was performed on 35 pediatric
patients with hematological malignancies who underwent TIVAPs
implantation via ultrasound-guided right BCV approach from July 2018 to
June 2021. Technical success rate, procedural information and TIVAP
related complications were evaluated. Results: All the pediatric TIVAP
devices were successfully implanted via right BCV access. Venous access
was successful by first attempt in 32 children (91.42\%); two cases
(5.71\%) required a second attempt; one patient (2.86\%) required a
third attempt. The mean procedural time was 44.63 \selectlanguage{ngerman}± 6.41 mins (range,
34-62 mins). No intraoperative complications occurred. The average TIVAP
indwelling time was 563.51 ± 208.47 days (range, 193-1014 days) with a
cumulative 19,723 catheter-days. The incidence of postoperative
complications was 11.43\% (4/35), corresponding to a rate of 0.20
complications per 1000 catheter-days. Two cases of local hematoma and
two catheter dysfunctions occurred in three patients. No other
complications such as wound dehiscence, delayed incision healing,
catheter-related thrombosis (CRT), catheter malposition/fracture,
surgical site infection, catheter-related bloodstream infection (CRBSI),
pinch-off syndrome and drug extravasation were observed during
follow-up. Conclusions: Ultrasound-guided right BCV access for TIVAPs
placement in pediatric patients appears to be technically feasible, safe
and effective. Further large-sample, prospective studies are warranted.%
\end{abstract}\selectlanguage{ngerman}%



\sloppy


\textbf{1 INTRODUCTION}

Childhood cancer burden is attracting global attention, with nearly 90\%
of those children from low- and middle-income
countries.\textsuperscript{1} Central venous access devices are
necessary for children with malignancy requiring long-term intravenous
therapy and routine laboratory tests.\textsuperscript{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).\textsuperscript{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.\textsuperscript{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,\textsuperscript{7} whereas the SCV access is prone to be
kinking such as pinch-off syndrome and has a relatively lower
first-attempt success rate.\textsuperscript{8} However, since the
initial report of ultrasound-guided brachiocephalic vein (BCV) approach
in the supraclavicular region by Breschan et al.\textsuperscript{9} in
2011, it has been widely used in
adults,\textsuperscript{10}children,\textsuperscript{11-13}
infants,\textsuperscript{14,15} and even premature
infants\textsuperscript{16-18} for central venous catheters (CVCs)
insertion procedure. And this approach is associated with a higher
puncturing success rate, shorter cannulation
time,\textsuperscript{10,19} and lower complication rate compared with
other approaches.\textsuperscript{12} As such, Avanzini et
al.\textsuperscript{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.\textsuperscript{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.

\textbf{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 \selectlanguage{ngerman}× 10\textsuperscript{9}/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 (\%).

\textbf{3} \textbf{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 × 10\textsuperscript{9}/L (IQR: 40, 233 ×
10\textsuperscript{9}/L) on admission to that of 137 ×
10\textsuperscript{9}/L (IQR: 70, 277 × 10\textsuperscript{9}/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).

\textbf{4 DISCUSSION}

Ultrasound-guided BCV approach has gained increasing popularity for CVCs
insertion in children\textsuperscript{11-13} and TIVAPs implantation in
adults.\textsuperscript{20-22} Anatomically, the BCV approach has
potential advantages during central venous cannulation compared with its
counterparts of IJV and SCV approach. On one hand, the BCV is formed by
the confluence of IJV and SCV posterior to the sternoclavicular joint
with fewer anatomical variants, whose caliber is also not affected by
patient's hemodynamic and volume status, respiratory motion, and
ultrasound probe compression;\textsuperscript{17} while puncturing the
BCV under ultrasound guidance, the entire needle trajectory, which is
parallel to the pleura, can be visualized in real-time by the operator,
decreasing the risk of pneumothorax. On the other hand, the lumen size
and blood flow of BCV are the largest among those available central
veins including IJV and SCV,\textsuperscript{18} and the
catheter-to-vein diameter ratio of the catheter (Babyport, 4.5F =
1.49mm) and BCV (about 3.2mm-diameter in infants)\textsuperscript{9} is
less than 45\%, which has been considered as a protective factor for
CRT;\textsuperscript{11} meanwhile, the flow of BCV is close to that of
the superior vena cava with low risk of flow disturbance, which further
decreases the risk of CRT.\textsuperscript{12}Moreover, the cannulation
site of the catheter is located in the supraclavicular
fossa,\textsuperscript{17} which may alleviate patient discomfort at the
neck,\textsuperscript{7} reduce the risk for
infection,\textsuperscript{12,18} and maintain a smoother catheter
curvature.\textsuperscript{21}

To our knowledge, no previous literature has evaluated using BCV
approach for TIVAPs placement in pediatric oncology population.
Right-sided approach was adopted universally in the present study group
due to the operator preference and the theoretical risk of thoracic duct
injury during left-sided BCV access. However, previous literature
suggested that the left BCV approach could be safe and reliable in
infants,\textsuperscript{14-16,23}children\textsuperscript{19,24} and
adults\textsuperscript{10} for CVCs catheterization. Some authors even
considered the left BCV approach to be superior to the
right\textsuperscript{15,16,19,24} because the left BCV courses
horizontally, the ultrasound-guided manipulation is
easier,\textsuperscript{16} with a higher successful cannulation rate by
first attempt.\textsuperscript{15} On the contrary, Avanzini et
al.\textsuperscript{11} believed that the left BCV approach may increase
the risk of CRT due to the greater surface contact between the catheter
and the vessel wall, so the right BCV should be recommended as the
preferred mode for access.

The technical success rate was 100\% in the present study group,
consistent with previous literature on BCV approach for CVCs
catheterization in children (94\%-100\%)\textsuperscript{11-13,16} and
TIVAPs placement in adults (96.5\%-100\%).\textsuperscript{10,21} In the
present study, the success rate for cannulation by first attempt was
91.42\% (32/35), similar to previous reports in adult studies
(90\%-99.30\%).\textsuperscript{10,21} But it was higher than those
reported for children
(65.4\%-73.8\%),\textsuperscript{9,12,16,17,25}which can be attributed
to differences in age and weight among different patient populations.
The majority of the children in the present study were older than 12
months, while most of the patients included in most other studies were
infants and even premature infants\textsuperscript{9,16,17,25} with
weigh as low as 2.5kg.\textsuperscript{9,16,17} According to the finding
reported by Breschan et al.,\textsuperscript{9}the younger age and lower
weight are associated with higher risk for repeated attempts in gaining
BCV access.\textsuperscript{9}

The correlation between proceduralist experience and patient outcome for
pediatric TIVAPs insertion continues to be a subject of investigation.
Recently, a study from Shilati et al.\textsuperscript{8} demonstrated
that, individual surgery volume and specialty training might influence
the incidence of early revision or replacement with an inverse
correlation. Limited by the small number of cases in the single
institutional children's hospital, it is difficult to accumulate a large
amount of experience in a short time. However, our surgeons were from
the integrated medical union of people's hospital, and we had extensive
experience with hundreds of ultrasound-guided BCV punctures for adult
TIVAPs procedures. In our children's population, no intraoperative
complications occurred despite the small sample cohort, the average
procedural time of 44.6 mins was comparable with the 41.7-47 mins
reported by Bawazir et al.,\textsuperscript{26} and the median
fluoroscopy time of 10 seconds was obviously shorter than that in other
study.\textsuperscript{8} Likewise, Oulego-Erroz et
al.\textsuperscript{17} emphasized the necessity for specialists to
receive training and gain experience in adults in advance, in order to
shorten the learning curve in children as soon as possible.

Within a cumulative 19,723 catheter-days in the present study, the total
and postoperative complication rates were both 11.43\% (4/35) due to no
occurrence of intraoperative complications, which translated into 0.20
complications per 1000 catheter-days. Such finding was in accordance
with prior published literature on children reporting complication rates
ranging from 7.46\% to 30\%\textsuperscript{7,27-29} and from 0.15 to
0.90 complications per 1000 catheter-days.\textsuperscript{30} However,
the incidence of total complications in adult literatures on BCV
approach ranged from 3.18\% to 6.00\%,\textsuperscript{21,22} which was
lower than that of our pediatric population. Thus, such difference in
spectrum of complications between adults and children is likely
attributable to differences in body size, vessel caliber and vertical
growth, which warrants further investigation.

Currently, there is no consensus regarding the safety of TIVAPs
placement in children with small body sizes, especially infants less
than 1 year of age. Two recent retrospective cohort studies showed that
patients with low weight (less than 7 kg) might be associated with an
increased risk of intra- or post-operative
complications.\textsuperscript{29,31} An infant with 6.3-kg-weight from
the present study developed local hematoma and catheter dysfunction
postoperatively. The hematoma was treated by repeated wet compress and
local pressure during the initial three days after surgery, then slowly
resolved after nearly two months. Chemotherapy had to be carried out
simultaneously due to disease progression. Generally, suturing is not
required for the skin incision at the exit of the catheter, but suture
was implemented in the present infant due to blood oozing to achieve
hemostasis at the end of the procedure. It is hypothesized that, the
blood from the venipuncture site seeped into the tunnel and accumulated
around the catheter and port pocket, leading to subsequent local
subcutaneous hematoma. In a challenging pediatric group with hemophilia,
early pocket site bleeding was not associated with increased episodes of
infectious complications.\textsuperscript{32} Therefore, noninvasive
methods are preferred for managing the local hematoma, and surgical
debridement should be a matter of prudence.

Catheter dysfunction, defined as inability of blood withdrawal with or
without difficulty of fluid injection, can be a sequela of fibrin sheath
formation, catheter thrombosis, or catheter tip adherence to the
vascular wall.\textsuperscript{2} This complication occurred in two
patients in the present study group, which were likely related to
intraluminal thrombotic obstruction without ability of blood aspiration
and fluid injection, one of whom was the infant presented with local
hematoma as described above. Patency was restored in both catheters by
thrombolytic treatment using urokinase (5,000 IU/ml). Previous studies
on TIVAPs and central venous catheters in children suggested catheter
dysfunction being the most common
complications,\textsuperscript{6,29}and the occurrence or recurrence of
such complication might be a warning of the increased risk of
CRT.\textsuperscript{33} Thus, once the event of catheter dysfunction
occur, it warrants sufficient attention by clinicians.

While some authors reported that infection is most common and serve as
the leading cause of unplanned device removal,\textsuperscript{34,35} no
infectious complications such as CRBSI and local infection were found in
the present pediatric series. For instance, in a large prospective
investigation including more than 4,000 adult
patients,\textsuperscript{36} port related infection was the most
frequent complication, which was associated with neutropenia after
high-intensity chemotherapy; the authors hypothesized that intravenous
chemotherapy should be carried out at least 6 days after TIVAPs
implantation to reduce infection risk. By contrast, in a
multi-institutional study of 500 children under 5-year-old, the most
common complications identified were mechanical in nature instead of
infectious events.\textsuperscript{30} Notably, the proportion of
infectious events was certainly not low, almost being the one of the top
two. Similar findings were also reported by two retrospective cohort
studies comprising infants less than
1-year-old.\textsuperscript{29,31}By comparison, all our patients
received chemotherapy within 3 days after surgery, though infection did
not occur. Larger prospective study is warranted to exclude the
possibility of the present study's underpowering as the cause of low
infection rate.

The present study should be interpreted with several caveats. Due to its
retrospective, single-center, and small-sample design, further
prospective, multi-institutional, large-sample sized study is required
to elucidate whether the new vascular access can be widely applied to
this specific patient population. And then, the outcome of the left BCV
access option was lacking in our pediatric series, deserving further
investigation. Furthermore, this study is noncomparative in nature,
comparative studies with IJV and/or SCV access are warranted to
determine the safety and efficacy of BCV access.

\textbf{5 CONCLUSION}

Overall, given the high technical success, safety and efficacy,
ultrasound-guided right BCV catheterization for TIVAPs implantation in
pediatric patients should be more widely adopted in experienced
operators. Further large-sized and comparative studies are warranted.

\textbf{FUNDING INFORMATION}

None.

\textbf{CONFLICT OF INTEREST}

All authors declare that there is no conflict of interest.

\textbf{DATA AVA ILAB IL ITY STATEMENT}

The data that support the findings of this study are available from the
corresponding author upon reasonable request.

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\textbf{Legends}

\textbf{TABLE 1} Patients' characteristics

\textbf{TABLE 2} Procedural details and outcomes

\textbf{FIGURE 1} Images of ultrasound-guided placement of TIVAP via the
right BCV in a 25-month-old child with retinoblastoma.

A: The ultrasound probe was placed in the right supraclavicular region
to obtain a longitudinal view of the right BCV (*), and the access
needle (white arrows) was advanced into the BCV. B: Fluoroscopy at
procedure end shows that the injection port was implanted in the right
infraclavicular area, and the catheter tip (white arrow) was located at
the cavoatrial junction. C: The skin incision of venipuncture is located
in supraclavicular site close to the neck, measuring 3-mm-length; the
port pocket incision is located in upper chest wall, measuring
approximately 2-cm-length, respectively. (\selectlanguage{english}\textsuperscript{}Indicates
the lung.)

\textbf{FIGURE 2} Clinical process of subcutaneous hematoma after TIVAP
implantation in a 2-month-old, 6.3-kg-weighted infant with acute
lymphoblastic leukemia.

A: During the first week after surgery, the hematoma adjacent to the
port pocket and tunnel was confirmed by ultrasound, which enlarged
progressively. B, C: Wet compress with 25\% magnesium sulfate solution
and a transparent patch followed by elastic bandage for pressure
dressing was applied for 3 days. D: Hematoma resolved two months later.
(White arrow indicates the skin incision at the venipuncture site.)

\textbf{Hosted file}

\verb`TABLE 1.docx`  available at \url{https://authorea.com/users/474333/articles/564225-ultrasound-guided-totally-implantable-venous-access-ports-placement-via-right-brachiocephalic-vein-in-pediatric-population-a-clinical-debut}

\textbf{Hosted file}

\verb`TABLE 2.docx`  available at \url{https://authorea.com/users/474333/articles/564225-ultrasound-guided-totally-implantable-venous-access-ports-placement-via-right-brachiocephalic-vein-in-pediatric-population-a-clinical-debut}\selectlanguage{english}
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\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/FIGURE-2/FIGURE-2}

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