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https://doi.org/10.1177/1129729819884482
The Journal of Vascular Access
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© The Author(s) 2019
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DOI: 10.1177/1129729819884482
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J VA e Journal of
Vascular Access
Introduction
Totally implantable vascular access devices (TIVADs),
also named ports, are widely used in cancer patients to
facilitate the infusion of intravenous chemotherapy (CT),
fluid supplementation and long-term supportive care.
Historically, TIVADs have been implanted into the ante-
rior chest wall accessing the subclavian or the internal
jugular vein.1–3 More recently, peripheral insertion of arm
TIVADs has become more widespread as an alternative to
chest wall TIVADs in an attempt to reduce complication
PICC-PORT totally implantable vascular
access device in breast cancer patients
undergoing chemotherapy
Sergio Bertoglio1,2 , Ferdinando Cafiero2, Paolo Meszaros3,
Emanuela Varaldo1,2, Eva Blondeaux4, Chiara Molinelli4 and
Michele Minuto1,2
Abstract
Background and objectives: The increasing use of arm totally implantable vascular access devices for breast cancer
patients who require chemotherapy has led to a greater risk of complications and failures and, in particular, to upper
extremity deep vein thrombosis. This study aims to investigate the outcomes of the arm peripherally inserted central
catheter-PORT technique in breast cancer patients.
Methods: The peripherally inserted central catheter-PORT technique is an evolution of the standard arm-totally
implantable vascular access device implant based on guided ultrasound venous access in the proximal third of the upper
limb with subsequent placement of the reservoir at the middle third of the arm. A prospective study was conducted on
418 adult female breast cancer patients undergoing chemotherapy. The primary study outcome was peripherally inserted
central catheter-PORT failure.
Results: Median follow-up was 215 days. Complications occurred in 29 patients (6.9%) and failure resulting in removal
of the device in 11 patients (2.6%). The main complication we observed was upper extremity deep vein thrombosis,
10 (2.4%); all patients were rescued by anticoagulant treatment without peripherally inserted central catheter-PORT
removal. The main reason for removal was reservoir pocket infection: 4 (0.9%) with an infection rate of 0.012 per 1000
catheter days. Cumulative 1-year risk of failure was 3.6% (95% confidence interval, 1.3%–7.1%). With regard to the
patients’ characteristics, body mass index <22.5 was the only significant risk for failure (p = 0.027).
Conclusion: The peripherally inserted central catheter-PORT is a safe vascular device for chemotherapy delivery that
achieves similar clinical results as traditional long-term vascular access devices (peripherally inserted central catheter and
arm totally implantable vascular access device, in particular) in breast cancer patients.
Keywords
Venous access device, totally implantable vascular access device, peripherally inserted central catheter, complications,
breast cancer, chemotherapy
Date received: 6 August 2019; accepted: 27 September 2019
1 Department of Surgical Sciences (DISC), University of Genova,
Genova, Italy
2 General Surgery Unit 1, Department of Surgery, IRCCS Ospedale
Policlinico San Martino, Genova, Italy
3
Breast Surgical Unit, Department of Surgery, IRCCS Ospedale
Policlinico San Martino, Genova, Italy
4 Oncologia Medica Unit 2, Department of Medical Oncology, IRCCS
Ospedale Policlinico San Martino, Genova, Italy
Corresponding author:
Sergio Bertoglio, Department of Surgical Sciences (DISC), University of
Genova, Largo Rosanna Benzi 10, 16132 Genova, Italy.
Email: sergio.bertoglio@unige.it
884482JVA0010.1177/1129729819884482The Journal of Vascular AccessBertoglio et al.
research-article2019
Original research article
2 The Journal of Vascular Access 00(0)
rates and improve the patients’ level of satisfaction. In par-
ticular, in female patients with breast cancer, the absence
of an additional scar on the chest and the easier access to
the port without the need to bare the chest represent a sig-
nificant cosmetic and psychological advantage.3,4 As is the
case with breast cancer patients, arm ports in patients who
have head and neck tumours and a tracheostomy can
potentially reduce infections since the access site in these
latter patients is far from tracheal secretions that might
facilitate cutaneous bacterial overgrowth increasing the
risk of TIVAD pocket infections.5–8
Despite these advantages, there are some concerns about
a higher incidence of complications in patients with arm
port devices as compared to chest ports.2 Catheter occlu-
sion, upper extremity deep vein thrombosis (UEDVT), skin
dehiscence and needle dislocation with drug extravasation
are reportedly responsible for the removal of the device in
4%–17% of patients.6–8
In order to evaluate the possibility of reducing the inci-
dence of arm TIVAD failures, the authors introduced a
technical variation to the standard method of arm port
placement named the peripherally inserted central catheter
(PICC)-PORT technique. It consists of a percutaneous
venous access through the basilic or brachial veins, which
is always performed under ultrasound guidance using the
micro-Seldinger technique that allows the venous catheter
to be inserted in the proximal third of the upper arm, close
to the axilla. The catheter is then tunnelled up to a pocket
in order to position the chamber located on the medial sur-
face of the mid-arm. The rationale for this surgical
approach variation to traditional arm port placement is
based on catheter insertion into a vein of larger calibre at
the proximal third of the upper arm. This may reduce the
probability of UEDVT as it respects an optimal catheter-
to-vein ratio.9–11 Moreover, tunnelling the catheter from
the insertion site to a port chamber located in the mid third
of the arm is consistent with the zone insertion method
(ZIM) principles for PICCs that indicate this area, called
the ‘green zone’, as the optimal one in order to prevent
PICC complications.12
This study was carried out to report the overall compli-
cations and failures of PICC-PORTs in female patients
with breast cancer undergoing chemotherapy.
Material and methods
This prospective cohort study was conducted at the
Policlinico San Martino Hospital, Genova (Italy), and
includes 209 PICC-PORT implants in adult female patients
with breast cancer requiring neo-adjuvant or adjuvant
chemotherapy (as indicated by our Institutional Breast
Cancer Unit) between 1 March 2017 and 1 March 2018.
The study followed the principles of the Helsinki
Declaration and was approved by the institutional review
board. Informed consent was obtained and signed by all
patients. The study reports the PICC-PORT outcomes of
all patients.
Study design and patients’ characteristics
This study aims to analyse the PICC-PORT outcomes in a
series of female breast cancer patients undergoing chemo-
therapy and takes advantage of the fact that all PICC-
PORT implants were unselected and consecutive. All
patients were outpatients receiving chemotherapy at fixed
intervals of time according to protocol schedules for dif-
ferent stages of breast tumours.
PICC-PORT implantation was in accordance with insti-
tutional protocols. Upper limb oedema, previous UEDVT
of the selected arm for the implant, and chronic renal fail-
ure with dialysis fistula were considered exclusion criteria
for PICC-PORT implantation.
A specific data base with data extracted from hospital
records was created to collect details on: demographics,
tumour stage, type of chemotherapy (i.e. neo-adjuvant or
adjuvant treatment), chemotherapy schedule, body side
and vein of insertion, body mass index (BMI) and catheter-
to-vein ratio, duration of the PICC-PORT, perioperative
complications, UEDVT, catheter-related bloodstream
infection (CRBSI), local infection, occlusion, catheter dis-
lodgement or malfunction. Follow-up lasted 12 months
and data collection terminated on 1 March 2019.
PICC-PORT implantation and maintenance
Implantation and maintenance were always performed by
the same physicians and nurses belonging to the PICC
team following evidence-based institutional protocols in a
dedicated surgical ward for vascular access placement
under local anaesthesia with maximal barrier and antisep-
sis precautions. The PICC-PORT was inserted in the
upper-arm of the unaffected breast cancer body side.
Percutaneous access was always performed under ultra-
sound guidance at the proximal third of the arm in the ‘yel-
low zone’ according to the PICC ZIM.12 Tourniquets were
never used to stop venous flow (Figure 1). The accessed
vein was always measured in order to obtain (whenever
possible) a catheter-to-vein ratio ⩽0.33.10,11,13,14 Catheter
tip location in the distal third of the superior vena cava was
assessed by fluoroscopy or ECG. A subcutaneous pocket
for port reservoir placement was obtained 3–5 cm distal to
the vein access in the mid third of the arm with a 15–20
mm cutaneous access in the so-called ‘green zone’.12 The
catheter was then tunnelled and connected to the reservoir
that was located in the subcutaneous pocket. Surgical
wound closure was performed by a running suture using a
4-0 monofilament absorbable suture. Prophylaxis for cath-
eter-related UEDVT was not routinely adopted as per cur-
rent guidelines.15,16 Implanted ports consisted of a low
profile, reduced-size titanium chamber attached to a power
Bertoglio et al. 3
injectable thermoplastic polycarbonate-urethane (PUR) 5F
catheter (Health PORT Minimax 5F, Plan1 Health, Udine,
Italy).
Care and maintenance of the devices was assigned to a
specialized PICC team of oncology nurses in accordance
with institutional protocols. The PICC-PORT reservoir
was always accessed by a 22 G × ¾ in non-coring needle.
Before needle insertion, the skin was always cleaned with
2% chlorhexidine gluconate (CHG) in a 70% isopropyl
alcohol solution. Flushing and locking of PICCs was per-
formed using prefilled 10 mL normal saline syringes by
the pulsatile method [10]. Non-accessed PICC-PORTs
underwent this procedure every 2 months.
Study endpoints
The primary endpoint was time to PICC-PORT failure
requiring device removal.
The onset and frequency of complications (i.e. UEDVT,
CRBSI, local skin infection, occlusion, catheter malfunc-
tion or drug extravasation) was reported as the secondary
outcome measure.
Definitions. The study population included adult female
cancer patients with breast cancer who were eligible for
neo-adjuvant or adjuvant chemotherapy.
Chemotherapy was defined as the use of intravenous
and/or oral chemotherapeutic regimens in accordance with
institutional protocols for different types and stages of
breast cancer.
Local skin infection was defined by the presence of
erythema and/or tenderness over the pocket of the reser-
voir and along the tunnelled catheter to the vein access,
with fever and regardless of the presence of purulent
discharge.
CRBSI was defined according to the Infectious Diseases
Society of America guidelines:15
Isolation of the same micro-organism in the periph-
eral blood and PICC cultures;
A threefold difference in paired quantitative cul-
tures of blood samples drawn from the PICC-PORT
and a peripheral vein;
Culture positivity in blood collected from the PICC-
PORT 2 h before positive cultures in peripheral
blood samples.
Catheter-related UEDVT was assessed by ultrasound
examination showing the presence of a thrombus with par-
tial or complete vein occlusion.
Drug extravasation was defined by the presence of
oedema, erythema, pain and tenderness without any signs
of local infection.
Catheter occlusion was defined as the inability to infuse
normal saline solution despite the manual pressure per-
formed on the piston of a ⩾10 mL syringe.
Statistical analysis
In the data analysis, descriptive variables are presented as
percent values. Statistical comparison was performed by
chi-square test analysis or Fisher’s exact test, or T-test
where appropriate. p values < 0.05 were considered sig-
nificant. Multivariate analysis was not performed on the
variables describing the possible risk factors associated
with postoperative complications due to no statistically
significant p values being observed in the univariate
model, with the exception of the BMI variable, and no spe-
cific interaction between the variables based on known
biological plausibility.
Time to PICC-PORT risk of failure was analysed using
standard survival techniques. One-year risk of failure was
computed from the day of PICC implantation to the day of
removal due to PICC-PORT failure. Cumulative 1-year
risk of failure was computed using the Kaplan–Meier
product limit estimator and was compared using a univari-
ate proportional hazard (PH) semi-parametric model,
which allowed to estimate univariate hazard ratios with
their 95% confidence interval (CI) and to assess the statis-
tical significance of the observed differences. In the analy-
ses, p < 0.05 was considered statistically significant.
STATA/SE 11.0 (Statacorp LP 2009) and SPSS 20 (IBM
SPSS Statistics, ed. 20, 2014) statistical software were
used for all analyses.
Results
Over a 12-month period, 418 consecutive, unselected adult
female breast cancer patients were implanted a PICC-
PORT device for adjuvant and neo-adjuvant chemotherapy
Figure 1. PICC-PORT insertion technique; venous access in
the ZIM technique ‘yellow zone’ with the catheter tunnelled
as far as the subcutaneous pocket for the reservoir in the ZIM
‘green zone’.
4 The Journal of Vascular Access 00(0)
at the IRCCS Policlinico San Martino in Genoa. The
inserted PICC-PORTs accounted for a total of 94,935 cath-
eter days; median length of observation was 215 days
(range, 25–365). PICC-PORTs were removed from all
patients at the end of the chemotherapy.
Patients’ baseline characteristics are shown in Table 1.
Patients below 50 years of age represented the majority of
PICC-PORT insertions (47%). Body mass index ranged
between 22.5 and 25 in 40% of patients. Over one half of
patients (54%) had AJCC-TNM Stage II breast cancer; the
majority of patients (83%) received adjuvant chemother-
apy treatment, and the association of epirubicin, cyclo-
phosphamide and taxanes represented the most commonly
used chemotherapy schedule (84%). Most PICC-PORTs
(60%) were inserted in the right side and into the basilic
vein (85%). The mean size of the accessed vein was 6.2
mm (range, 4.7–10.9) and a catheter-to-vein ratio ⩽ 0.33
was obtained in the majority (93%) of procedures. No
perioperative complications were observed except for tem-
porary subcutaneous ecchymosis in the arm lasting from 3
to 7 days which occurred in 125 (30%) subjects; ecchymo-
sis was perceived by patients as a minor nuisance more
than a complication
Three hundred and seventy-four PICC-PORTs (89%)
were removed without failure at the end of the patient’s
chemotherapeutic programme and 17 were left in place
following the physician’s decision. Kaplan–Meier cumula-
tive 1-year risk for failure was 3.6% (95% CI, 1.3%–7.1%)
(Figure 2).
Table 2 analyses the frequency of complications and
failures. Complications occurred in 29 PICC-PORTs
(6.9%), and 11 (2.6%) were eventually removed due to
failure.
Local pocket infection with PICC-PORT avulsion
occurred in four patients (0.9%) and median time to
removal was 114 days with an infection rate of 0.012 per
1000 catheter days. Catheter occlusion requiring removal
arose in three (0.7%) PICC-PORTs and median time to
removal was 196 days. CRBSI was seen in two (0.5%)
PICC-PORTs, both of which were removed, and median
time to removal was 189 days with a local infection rate of
0.016 per 1000 catheter days. Unexpected drug extravasa-
tion occurred in six subjects (1.4%), two of whom under-
went PICC-PORT removal (0.5%) at a median time of 107
days. Symptomatic UEDVT was observed in 10 (2.4%)
PICC-PORTs, but none of them were removed. Median
time to UEDVT-related symptoms was 78 days and all
patients received low-molecular-weight heparin which
was maintained the whole time the PICC-PORT was in
use. No pulmonary embolisms were observed. One case
each of skin dehiscence and port leakage occurred (0.5%),
though without PICC-PORT removal. Difficulty drawing
blood developed in 72 (17.2%) patients.
The risk of PICC-PORT failure based on the patient’s
characteristics is reported in Table 3. Age, body side of
implant, vein of insertion, catheter-to-vein ratio, stage of
cancer, type of chemotherapy (i.e. neo-adjuvant or adju-
vant treatment) and chemotherapy schedule were not pre-
dictive of failure. The only relevant risk factor we found
for PICC-PORT failure was BMI < 22.5 (p = 0.027).
Discussion
Central venous catheters (CVCs) are commonly used for
adjuvant chemotherapy delivery in breast cancer patients.
There is no evidence to routinely recommend a specific
type of CVC for all patients since the choice is mainly
influenced by the expected duration of treatment, the type
of chemotherapy, the patient’s compliance and the ability
to provide care and maintenance of the device.17–19
For decades chest TIVADs have been considered a
standard of care for i.v. chemotherapy.2,3,5 Despite their
safety and efficacy, some issues have been raised over
their use. In particular, for female breast cancer patients
eligible for adjuvant chemotherapy, the invasive procedure
Table 1. Patients’ characteristics.
Patients’ characteristics Total (n = 418)
n%
Age
<50 197 47.12
50–59 85 20.33
>60 136 32.53
Body mass index
<22.5 134 32.05
22.5–25 166 39.71
>25 118 28.22
Breast cancer stage
Stage I 192 45.93
Stage II 226 54.06
Type of chemotherapy
Adjuvant treatment 348 83.25
Primary chemotherapy 70 16.74
Chemotherapy schedule
EC/taxanes 352 84.21
Taxanes/trastuzumab 66 15.78
Access side
Right side 250 59.80
Left side 168 40.19
Access site
Basilic vein 354 84.68
Brachial/axillary vein 64 15.31
No. of vein access attempts
1 attempt 388 92.82
2 attempts 30 7.17
Catheter-to-vein size ratio
⩽0.33 392 93.77
⩾0.33 26 6.22
EC: epirubicin and cyclophosphamides.
Bertoglio et al. 5
and the cosmetic impact of the residual skin scar on the
anterior thoracic wall often represent negative fea-
tures.4,19–22 The use of TIVADs inserted in the arm or fore-
arm has grown steadily over the years. Although having
similar indications to chest TIVADs, there is the percep-
tion that arm port implantation is an easier and less inva-
sive procedure. Despite these advantages, to date arm ports
have not been fully adopted in clinical practice because of
the higher late complication rates leading to failure and
avulsion of the device. The majority of these complica-
tions are attributable to infections and thrombosis.
Bodner et al.5 reported arm port failure rates of up to
18% in a series of 109 patients. More recently, on a larger
series of 433 patients, Mori et al.6 demonstrated a 19% late
postoperative complication rate of arm ports and a 16%
rate of avulsion due to failure.
A national Japanese survey by Shiono et al.7 showed an
overall incidence of complication rates of 7.3% and 5.2%
in forearm and arm implanted ports, respectively. The
majority of reported complications in these studies were
infections and venous thromboses. Tippit et al.8 recently
showed that the use of arm ports in breast cancer patients
is responsible for a 9.5% incidence of UEDVT, almost five
times higher than what is observed for traditional chest
TIVADs, with a relative risk of 4.76 (p < 0.005). Reports
in the literature would appear to indicate a somewhat
higher incidence of complications and failures of arm ports
as compared to chest ports, with infections and DVT being
mainly responsible for these results.2,9,23 When PICCs
were used in cancer patients undergoing chemotherapy,
the overall complications were found to be equal to or
even higher than what is reported for arm ports and ranged
from 6% to 20%.10,14,24
This study aims to evaluate the use of the PICC-PORT
surgical approach as a standard insertion method for
TIVADs in the proximal upper limb of women with breast
cancer as a possible alternative to traditional arm ports in
order to reduce complications and failures.
PICC-PORTs were removed due to failure before the
end of treatment in 3.8% of patients. The overall failure
rate is consistent with the ranges previously reported for
chest TIVADs (1.5%–8%).2,3,23–25 On the contrary, failure
rates were lower than those reported for arm TIVADs,
which range from 5% to 20%.10,14,24
Symptomatic UEDVT was the main reason for PICC-
PORT removal and accounted for more than one-third
(2.4%) of all failures. These results were consistent with
those reported in large literature series of oncologic
patients bearing mid- or long-term central venous access
devices for chemotherapy delivery.2,3,23 It is noteworthy
that studies in which PICCs were implanted solely in
oncologic patients showed a slightly higher incidence of
UEDVT, ranging from 4% to 50%.2,3,24–26
In our study, all the PICC-PORTs with UEDVT were
rescued by implementing low-molecular-weight heparin,
thus allowing the devices to be used until the end of chem-
otherapy, and thereby preventing unnecessary removal. In
our opinion, the low incidence of UEDVT in our patients
with PICC-PORTs is attributable to two main factors.
First, the use of the micro-Seldinger technique together
with the ultrasound-guided technique guaranteed little
trauma to the venous wall during the catheter insertion
procedure. Second, venous access performed in Dawson’s
‘yellow zone’ of the proximal third of the upper limb
allowed us to respect an optimal catheter-to-vein ratio
<0.33 in 93% of cases. The incidence of other factors
resulting in failure (i.e. catheter occlusion, CRBSI, pocket
infection, skin dehiscence, drug extravasation and drug
leakage) was consistent with literature reports. Median
dwell time for any failure was always >100 days, thus
supporting the efficacy of our vascular access management
institutional protocols.
This is relevant when compared to previous literature
reports with PICCs and arm TIVADs in oncologic patients
in whom the dwell time to failure was notably shorter.5,10,13
Figure 2. Kaplan–Meier curve for PICC-PORT cumulative
1-year risk of failure.
Table 2. Frequency of complications and removal of 209
observed PICC-PORTs.
Type of complication Total
complications
Port removal
due to failure
n%n%
Catheter occlusion 3 0.7 3 0.7
PICC-PORT CRBSI 2 0.5 2 0.5
Pocket infection 4 1 4 1
Skin dehiscence 2 1.0 – –
Drug extravasation 6 1.4 2 0.5
Drug leakage 2 0.5 – –
PICC-PORT UEDVT 10 2.4 – –
Total 29 6.9 11 2.6
CRBSI: catheter-related bloodstream infection; UEDVT: upper extrem-
ity deep vein thrombosis; PICC: peripherally inserted central catheter.
Multiple complications in the same subject were counted only once.
6 The Journal of Vascular Access 00(0)
To the best of our knowledge, this is the first report of
long-term outcomes regarding the PICC-PORT technique
in patients with early stages of breast cancer who received
neo-adjuvant or adjuvant chemotherapy. The study has
several strengths: it was a prospective study in which only
early stage breast cancer patients undergoing chemother-
apy were enrolled: in order to minimize the selection bias
all patients were unselected and consecutive. PICC-PORT
insertion and maintenance were performed by the same
staff in accordance with established institutional protocols,
and adequate median length of follow-up was available
(215 days). Nevertheless, there are some limitations. First
of all, the study was only carried out on breast cancer
patients and the results may not be representative of all
cancer patients. Second, patients were not routinely
screened for DVT in the absence of symptoms, thus
excluding asymptomatic patients from PICC-PORT out-
come evaluations. Third, the concomitant use of anticoag-
ulants or anti-platelets was not assessed and this could in
some manner influence the reported incidence of UEDVT.
In conclusion, our study has some implications for
patients with early stage breast cancer eligible for chemo-
therapy. Safe vascular access is without exception needed
and physicians are always required to consider the risks
and benefits of selected vascular access devices (i.e. tun-
nelled catheters, PICCs or TIVADs). If the choice is a
TIVAD, the use of a PICC-PORT would appear to be safe
and reliable. Its easy implantation, low risk of complica-
tions and the excellent cosmetic result, even after removal
at the end of chemotherapy, are strengths that support their
widespread use as a possible alternative to traditional chest
and arm TIVADs. Further studies are needed to assess the
use of PICC-PORTS in other clinical settings.
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with
respect to the research, authorship and/or publication of this
article.
Funding
The author(s) received no financial support for the research,
authorship and/or publication of this article.
ORCID iD
Sergio Bertoglio https://orcid.org/0000-0001-7235-3444
Table 3. Risk of failure based on the patients’ characteristics.
No. of
patients
No. of
failures
1-year cumulative
incidence of failure % (SE)
pa
Age
<50 197 6 6.0 (3.0) 0.478
50–59 85 3 3.9 (2.8)
60+136 2 2.6 (2.5)
Body mass index
<22.5 134 7 7.6 (4.1) 0.027
22.5–25 166 0 0 (0)
>25 118 4 5.5 (3.1)
Side of implant
Right 250 6 3.9 (2.2) 1
Left 168 5 3.2 (2.5)
Site of implant
Basilic vein 354 7 3.8 (1.4) 0.107
Brachial vein 64 4 10.5 (6.4)
Catheter-to-vein ratio
⩽0.33 392 11 5.8 (1.8) 1
>0.33 26 0 0 (0)
Disease stage
Stage I 192 7 8.0 (3.2) 0.147
Stage II 226 4 1.9 (1.4)
Type of CT
Adjuvant 348 11 4.7 (2.0) 0.357
Neoadjuvant 35 0 0 (0)
CT Schedule
EC + TAX 352 8 3.5 (1.9) 0.361
TAX + Her 66 0 0 (0)
CT: chemotherapy; EC: epirubicin and cyclophosphamides; TAX: taxanes; Her: trastuzumab; SE: standard error.
aTwo-tailed Fisher’s exact test.
Bertoglio et al. 7
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