1

University of Cape Town

Department of Surgery

FOLEY CATHETER BALLOON TAMPONADE FOR

PENETRATING NECK INJURIES AT GROOTE SCHUUR

HOSPITAL: AN UPDATE

Dr Matthias Frank Scriba

SCRMAT001

SUBMITTED TO THE UNIVERSITY OF CAPE TOWN

In fulfilment of the requirements for the degree of

MASTERS OF MEDICINE IN SURGERY

Faculty of Health Sciences

University of Cape Town

January 2020

Supervisor:

Professor Pradeep Navsaria

University of Cape Town

Department of Trauma Surgery, Groote Schuur Hospital

Univers

ity of

Cap

e Tow

n

The copyright of this thesis vests in the author. No quotation from it or information derived from it is to be published without full acknowledgement of the source. The thesis is to be used for private study or non-commercial research purposes only.

Published by the University of Cape Town (UCT) in terms of the non-exclusive license granted to UCT by the author.

Univers

ity of

Cap

e Tow

n

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TABLE OF CONTENTS

DECLARATION 3

ACKNOWLEDGEMENTS 4

LIST OF FIGURES AND TABLES 5

ABBREVIATIONS 6

ABSTRACT 8

LITERATURE REVIEW 10

Introduction 10

Historical Perspective 10

Demographics and Outcomes 11

Management Strategies in Penetrating Neck Injuries 14

Investigations for PNI 17

Management of Vascular Injuries 19

Foley Catheter Balloon Tamponade (FCBT) 19

Definitive Management of Vascular Injuries 24

Conclusion 26

References 27

PUBLICATION READY MANUSCRIPT 31

Introduction 31

Methods 31

Results 33

Discussion 38

Conclusion 41

Tables and Figures 42

References 51

Appendices 52

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DECLARATION

I, Matthias Frank Scriba, hereby declare that the work on which this dissertation/thesis is based is my

original work (except where acknowledgements indicate otherwise) and that neither the whole work

nor any part of it has been, is being, or is to be submitted for another degree in this or any other

university.

I empower the university to reproduce for the purpose of research either the whole or any portion of

the contents in any manner whatsoever.

Signature:

Date: 5th January 2020

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ACKNOWLEDGEMENTS

I would like to express my sincere gratitude to my supervisor Professor Pradeep Navsaria for his

guidance and support which have made this study and manuscript possible.

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LIST OF FIGURES AND TABLES

Literature Review

Tables

Table 1. Comparison of international and South African PNI studies

Table 2. Hard and soft signs of vascular and aerodigestive tract injuries

Table 3. Comparison of vascular imaging modalities for PNI

Table 4. Comparison of recent PNI studies that include FCBT

Figures

Figure 1. Anatomical zones for penetrating neck injury

Figure 2. Technique of Foley catheter insertion for penetrating neck injury

Figure 3. Algorithm for Foley catheter balloon tamponade in penetrating neck injury

Manuscript

Tables

Table 1. Recent PNI reports that include FCBT

Table 2. Admission vital signs an injury severity scores in 95 patients

Table 3. Facility designation and number of catheters placed per patient.

Table 4. Foley Catheter Placement Complications

Table 5. Vascular injuries identified

Table 6. Overall Morbidities

Figures

Figure 1. Algorithm for Foley catheter balloon tamponade in penetrating neck injury

Figure 2. Photograph of patient with left neck stab wound who required the insertion of 4 Foley

catheters to arrest active bleeding.

Figure 3. Successful FCBT for actively bleeding right-sided zone I neck stab with subclavian artery

injury.

Figure 4. Summary of Arterial and Venous Injuries

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ABBREVIATIONS

ATLS = Advance Trauma Life Support

CDA = Catheter-directed angiography

CT = Computerised tomography

CTA = Computerised tomography angiography

DSA = Digital subtraction angiography

EAST = Eastern Association for the Surgery of Trauma

FC = Foley catheter

FCBT = Foley catheter balloon tamponade

GCS = Glasgow Come Scale

GSH = Groote Schuur Hospital

GSW = Gunshot wounds

IQR = Interquartile range

ISS = Injury Severity Score

MRA = Magnetic resonance angiography

NISS = New Injury Severity Score

NM = Not mentioned

NOM = Non-operative management

OR = Operating room

PNI = Penetrating neck injury

RTS = Revised Trauma Score

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SW = Stab wounds

TRISS = Trauma and Injury Severity Score

USA = United States of America

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ABSTRACT

Introduction

Foley catheter balloon tamponade (FCBT) for bleeding penetrating neck injuries (PNIs) is an

effective, readily available and easy-to-use technique. This study aims to audit the technique and

highlight current investigative and management strategies.

Methods

All adult patients (18 years and older) with PNIs requiring FCBT presenting to Groote Schuur

Hospital (GSH) within a 22-month study period were included. Data were captured on an approved

electronic registry and analysed. Parameters analysed included demographics, major injuries,

radiological imaging, management and outcomes.

Results

Over the study period a total of 628 patients with PNI were managed at GSH, in which 95 patients

(15.2%) FCBT was utilised. The majority were men (98%) with an average age of 27.9 years. Most

injuries were caused by stab wounds (90.5%). The majority of catheters (81.1%) were inserted prior

to arrival at GSH (1.1% prehospital, 45.3% at clinic level and 34.7% at district hospital level).

Computerised tomography angiography (CTA) was used in 92.6% of patients, while 8 patients (8.4%)

required catheter-directed angiography. Of these, two were diagnostic and 6 were performed for

interventional endovascular management. A total of 34 arterial injuries were identified in 29 patients.

Ongoing bleeding was noted in only three patients, equating to a 97% success rate for haemorrhage

control. Thirteen (13.7%) patients required open neck surgery. Seventy-two (75.8%) patients without

major arterial injury had removal of the catheter at 48-72 hours post injury. Only two of these had

bleeding on catheter removal. Fifteen patients required ICU admission. A total of 36 separate

morbidities were documented in 28 patients (29.5%). There was only one death attributable to

uncontrolled haemorrhage from the neck wound.

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Conclusion

This large series shows the current use of FCBT for PNI. It highlights ease of use, high rates of

success at haemorrhage control (97%) and good outcomes. Venous injuries and minor arterial injuries

can be managed with this technique definitively.

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LITERATURE REVIEW

INTRODUCTION

The medical literature is abundant with reports on penetrating neck injury (PNI). These range from

case reports and series of historical interest, to more recent larger civilian cohorts with up-to-date

recommendations, guidelines and algorithms for the contemporary management of such injuries.

Despite these recommended protocols, the management of penetrating neck injuries (PNIs) remains

controversial. This current literature review focuses on vascular injuries associated with penetrating

neck trauma.

HISTORICAL PERSPECTIVE

Penetrating trauma to the neck has been described as far back as 1600 BC in the Edwin Smith

Surgical Papyrus [1], which contains 48 trauma case studies, including a penetrating cervical spine

injury (case #30) [2] and an oesophageal injury (case #28) [3] both from stab wounds. Ambrose Pare

in 1552 ligated both a common carotid artery and jugular vein injury in a soldier with a penetrating

neck wound. The soldier reportedly developed significant central neurology, but survived [4]. The

first successful carotid artery ligation without neurological sequelae was performed by Fleming in

1803 [4].

The current accepted approach seems to have gone full circle from complete non-surgical

management, to an era of mandatory surgical exploration to a more recent, well established highly

selective operative approach. Non-operative management was considered the standard of care up to

the First World War (1914 – 1918) with mortality rates of around 15 % [3, 4]. By the time the Second

World War (1939 – 1945) was fought, surgical exploration consisting mainly of ligation of injured

cervical vessels, was the order of the day. Mandatory surgical exploration became the standard of care

during the Vietnam War (1955 – 1975). This approach was transferred to the civilian setting, where

urban trauma centres advocated that all injuries breaching the platysma warranted surgical exploration

[3, 4]. However, more recently, management strategies have once again swung towards a more

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conservative approach, with selective non-operative management, following a thorough clinical

examination and aggressive diagnostic investigative algorithm, considered now to be the standard of

care [5, 6].

DEMOGRAPHICS AND OUTCOMES

Penetrating neck injuries are seen the world over, but prevalence varies greatly in different parts of the

globe. Case series from Europe and East Asia show a low prevalence of PNI. In their case series from

France, de Régloix et al [7] encountered an average of 2 patients with PNI per month over their 2-year

study period, while Kasbekar et al [8] (England) and Prichayudh et al [9] (Thailand) had an average

of less than 1 patient per month in their case series. Case series from the United States of America

have a higher prevalence. Demetriades et al [10] encountered an average of 11 patients per month,

while a more recent case series from 2018 by Ibraheem et al [11], had an average of 4 patients per

month. In comparison, South African studies show a much higher prevalence of PNI, with monthly

averages ranging between 11 and 19 patients per month [12, 13, 14, 15, 21].

Contrary to this difference in prevalence, demographics of PNI patients are quite similar in all

regions. All studies show a significant young adult male predominance. Low-velocity gunshot and

knife wounds are the predominant injuring mechanisms. Other less common mechanisms, such as

debris acting as a projectile are also described [7]. In most papers, knife stabbings are by far the most

prevalent, however some studies show a much higher rate of gunshot wounds [10]. Table 1 compares

international and South African PNI demographics, mechanisms of injury, surgical management and

outcomes.

Patient outcomes from PNIs vary, but seem to reflect relatively good outcomes considering the

abundance of vital structures contained so close together in a small, confined space. A number of

studies report no deaths [13, 14, 16], while others reveal mortality rates ranging from 1.8% - 11%.

These recorded mortalities however reflect in-hospital mortality only and do not consider those

patients dying at the scene or en-route to hospital. This is highlighted by McQuaide & Villet [18]. In

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their series of 266 patients with PNI, 9 in-hospital deaths were encountered. During the same period a

further 108 PNI cases were seen at the Government mortuary, suggesting an overall PNI mortality

rate of 32.3%. Madsen et al [15], in a more recent study, showed an in-hospital mortality rate of 2%.

Only 10 patients in their cohort of 510 PNI patients died while in hospital. However, mortuary data

from the same study period revealed a further 102 deaths attributed to PNI, raising the overall

mortality rate attributable to PNI to 17% [15].

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Table 1. Comparison of international and South African PNI studies (N = total patient number; SW = stab wounds; GSW = gunshot wounds; NOM = non-operative management;

USA = United States of America; NM = not mentioned).

Authors Country/Year N Study

Period

(months)

Average PNI

pts/month

Average

Age (yrs)

Gender

(men %)

SW

(%)

GSW

(%)

NOM

(%)

Needed

Surgery (%)

Negative

Explorations (%)

Mortality

(%)

International Studies

Narrod & Moore [16] USA 1984 77 120 0.6 32 77 66 29 38 62 15 0

Demetriades et al [10] USA 1997 223 20 11.1 29 89 40 47 83 17 1 2.7

Prichayudh et al [9] Thailand 2015 86 120 0.7 27 90 74 19 52 48 4 2

Teixiera et al [17] Brazil 2016 161 60 2.7 26 88 82 18 60 40 0 1.9

de Régloix et al [7] France 2016 55 24 2.3 32 84 57 16 58 42 NM 11

Kasbekar et al [8] England 2017 63 72 0.9 33 NM 52 NM 65 35 77 NM

Ibraheem et al [11] USA 2018 337 96 3.5 30 81 62 31 65 35 13 4.5

Hundersmarck et al [19] Netherlands 2019 43 108 0.4 40 79 53 5 47 53 29 7

South African Studies

McQuaide & Villet [18] 1969 266 48 5.5 26 90 99 1 46 54 22 3.4

Campbell & Robbs [12] 1980 108 7 15.4 29 89 98 2 76 24 0 2.8

Ngakane et al [20] 1990 109 36 3.0 30 87 83 11.0 97 3 0 1.8

Apffelstaedt &Müller [13] 1994 393 21 18.7 30 NM 100 0 0 100 58 0

Thoma et al [14] 2008 203 13 15.6 29 91 78 21 12 88 0 0

Madsen et al [15] 2015 510 46 11.1 29 89 89 11 79 21 0.3 2

Madsen et al [21] 2018 817 72 11.3 28 88 87 13 NM NM NM NM

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MANAGEMENT STRATEGIES IN PENETRATING NECK INJURIES

The optimal management of PNIs remains controversial. The initial strategy of observing these

patients (as before World War I), led to unacceptably high mortality rates. Fogelman & Stewart [5]

recognised that many seemingly asymptomatic patients have serious underlying injuries and coupled

with the recognition that most neck explorations are associated with low morbidity rates, the emphasis

shifted towards exploring all wounds that breach the platysma muscle. However, this led to high rates

of negative and unnecessary neck explorations, prompting the notion that perhaps a more selective

process is required [5]. Apffelstaedt & Müller [13] showed a very high 58 % negative exploration rate

in their case series of 393 patients, who were all managed by mandatory neck exploration. Despite

their argument that mandatory exploration decreases missed injuries and reduces mortality and

morbidity, this must be balanced against unnecessary operations leading to increased healthcare costs

and iatrogenic injuries. The question is thus to find an optimum management strategy without

compromising patient outcomes.

In an attempt to address this question, the “neck zone” approach was developed. Monson et al in 1969

[22], initially described three zones of the neck. Since this initial “neck zone” description, some

modifications have taken effect and the current described borders of the neck zones pertain to the

anterior neck triangle only (i.e. anterior to the posterior border of the sternocleidomastoid muscle).

Zone I extends from the jugular notch to the cricoid cartilage, Zone II from the cricoid cartilage to the

angle of the mandible and Zone III from the angle of the mandible to the mastoid process [6].

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Figure 1. Anatomical zones for penetrating neck injury (taken from Von Waes et al. Management of penetrating

neck injuries [23])

The importance of this distinction lies in the fact that these zones were suggested to correlate with

underlying vascular and aerodigestive structures of importance and thus external injury was proposed

to predict internal injuries. Furthermore, they also affect surgical access, as Zones I and III are

certainly much more difficult to access. Zone I includes the thoracic inlet and surgical access often

requires median sternotomy, while Zone III is often treated more like a potential head injury and thus

may require craniotomy, or temporomandibular joint dislocation/subluxation for high internal carotid

artery exposure [3]. Zone II is much more readily accessible, usually via an anterior

sternocleidomastoid incision [3]. This led to the suggestion that injuries in Zone I and III should be

appropriately investigated first, while all Zone II injuries should be surgically explored [24]. This

approach has limitations, with a high negative exploratory rate for Zone II neck injuries, thus a

selective approach for these injuries was also suggested.

Many authors now believe the “neck zone” approach is clinically irrelevant and advocate for a “no

zone” approach [24, 25]. Low et al [25] showed a high rate of non-correlation between external

wounds in a specific zone and major internal injuries. With the “no zone” approach the

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haemodynamic status of the patient, and the use of clinical examination and appropriate

investigations, are used to guide whether operative intervention is indeed necessary, rather than the

site of the external injury [24].

Clinical signs of vascular and aerodigestive tract injuries are categorised into “hard” and “soft” signs,

with “hard” signs suggesting overt evidence of major injury. Hard signs of vascular injury include:

severe/uncontrolled haemorrhage, haemodynamic instability (shock not responding to fluid

resuscitation), expanding/pulsatile haematoma, bruit/thrill, absent/diminished distal pulses or

neurologic deficit (indicating cerebral ischaemia) [6, 26]. Less overt or “soft” signs of major injury

include: proximity injury, mild hypotension or history of hypotension (responds to resuscitation),

minor haemorrhage, haemoptysis/haematemesis, simple haematoma (not pulsatile/expanding and no

bruit/thrill), dysphagia/odynophagia, dysphonia, subcutaneous or mediastinal air [26].

Hard Signs Soft Signs

Vascular Bleeding: severe or uncontrolled

Haemodynamic instability (not responding to

resuscitation)

Haematoma: expanding or pulsatile

Bruit or thrill

Absent distal pulse (radial pulse)

Central neurologic fallout

Proximity injury

Bleeding: minor

Hypotension responding to fluid

Haematoma: non-pulsatile, non-expanding

Aerodigestive Air bubbling through the wound

Massive haemoptysis or haematemesis

Airway compromise or respiratory distress

Dysphonia

Dysphagia/odynophagia

Subcutaneous/prevertebral/mediastinal air

Haemoptysis/haematemesis: minor

Table 2. Hard and soft signs of vascular and aerodigestive tract injuries

The accuracy of these clinical signs to predict the presence of a major vascular injury and to

determine the need for operative intervention has also been queried. Data from the 1994 study by

Apffelstaedt & Müller [13], highlighted that clinically asymptomatic patients may harbour major

injuries and conversely, the presence of hard signs may not be associated with a major injury. They

showed that 30% of patients with no major clinical signs had positive findings intra-operatively, while

a significant proportion of patients with hard signs had a negative neck exploration (this included

shock, active bleeding, haematoma, surgical emphysema, dysphagia, and a blowing wound) [13].

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However, more recent consensus suggests that a thorough systemic enquiry and clinical examination

to be 95% accurate in identifying major vascular or aerodigestive tract injuries that require operative

intervention [5, 26]. It is evident that most surgeons would not argue with the notion that any patient

with a PNI with ongoing, uncontrolled external bleeding and haemodynamic compromise, or an

obvious major airway injury, is not a candidate for ancillary investigations and should be expedited to

the operating theatre.

INVESTIGATIONS FOR PNI

The Eastern Association for the Surgery of Trauma (EAST) guidelines on PNI [5] stipulate that

“given the potential morbidity of missed injuries, clinicians should have a low threshold for obtaining

imaging studies” [5]. As the notion of selective non-operative management of these injuries with the

selective use of diagnostic modalities became readily accepted, the ideal investigation of choice for

identifying vascular injuries was unclear. These included arteriography (i.e. catheter-directed

angiography) to exclude arterial injury and endoscopy (oesophagoscopy and laryngoscopy) or

oesophageal contrast study (oesophagogram) for suspected aerodigestive tract injuries [26]. Other

investigations available include duplex doppler and computerised tomographic angiography (CTA), of

which CTA has received a lot of attention more recently. With the increasing availability, relative

ease of use, and rapidly advancing technology with high sensitivity, specificity and accuracy, CTA

has become the investigation of choice in many centres. Its main use comes in identifying major

vascular injuries requiring intervention, but it also has a role in diagnosing aerodigestive tract injuries.

Although these injuries are less reliably diagnosed with CT, evidence of a stab or gunshot tract

running distant to the aerodigestive tract organs has been shown to decrease the need for further

investigations such as endoscopy or oesophageal contrast studies [27].

However, it is important to also realise that CT angiography has associated risks, including ionizing

radiation and contrast-related adverse events, and that it is not an infallible investigation, with some

studies showing less-than-desirable accuracy rates for the detection of vascular injuries. Bodanapally

et al [28] reviewed 53 CT scans of patients with PNI and compared this to digital subtraction

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angiography (DSA), which they considered to be the gold-standard investigation. CT scanners used

for this study Although they found a specificity of 96.4 % - 98.4 % for the detection of arterial injuries

in general, sensitivity for the detection of external carotid artery injuries specifically was much lower

at 63.4 % - 70.0 %, indicating that CT angiography missed about one third of external carotid artery

injuries. The authors conclude that negative findings on CT angiography should not preclude close

clinical follow-up and that if doubt exists DSA should be performed [28]. Importantly, this 2015 study

made use of 40 and 64-slice multidetector CT angiography, which may be considered outdated in

some modern centres. Other studies suggest much better CTA accuracy rates, with 100% sensitivity in

arterial injury diagnosis [29].

The EAST guidelines on PNI [5] highlight similar points and suggest that either CT angiography or

Duplex Doppler can be used to assess for vascular injuries. Concern with CT angiography is that

intimal injuries are often missed, while Duplex Doppler is a better imaging modality to identify

intimal tears [5]. Duplex Doppler is less invasive and in skilled hands has high accuracy rates [29],

however the concern of inter-user variability questions the consistency of the accuracy rates of this

imaging modality (Table 3), and is thus rarely used ahead of CT angiography. Furthermore, magnetic

resonance angiography (MRA) is reported as an imaging modality for PNI, but is also rarely used,

because of issues of availability, length of time to do the investigation, cost and significant

interference from movement and metallic streak artefact [29].

Imaging Modality Advantages Disadvantages Sensitivity Specificity

Catheter-directed

Angiography (CDA)

- Considered the “gold

standard”

- Most accurate – used as

comparative modality to

measure accuracy

- Invasive

- Risk of arterial puncture

site injury

- Ionizing radiation

- IV contrast

N/A N/A

Computed

Tomography

Angiography (CTA)

- More accessible than CDA

- Less invasive than CDA

- Ionizing Radiation

- IV contrast

75.7%–100% 93.5%-98.4%

Duplex Doppler - Non-invasive

- No radiation

- High accuracy for intimal

injury compared to CTA

- High inter-user

variability

91%-100% 85%-100%

Table 3. Comparison of vascular imaging modalities for PNI. (N/A = not applicable) [28,29]

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MANAGEMENT OF VASCULAR INJURIES

As with any trauma, managing patients with PNI begins with a primary survey according to Advanced

Trauma Life Support® (ATLS) principles [30]. Managing the airway in penetrating neck trauma can

be difficult and bleeding too, can be troublesome. Occlusion of the airway can occur because of direct

injury to the larynx or trachea, expanding haematoma in the neck, or can occur due to bleeding or

aspiration of blood into the airway. Injury to the pleura is possible from a neck wound as the apex of

the lung extends above the clavicle. This can lead to haemo- or pneumothoraces, which impair

ventilation but when severe (i.e. tension pneumothorax) can lead to haemodynamic instability

unrelated to bleeding. Massive external bleeding from sources in the base of skull, neck or thoracic

inlet is usually evident, but less evident internal bleeding may occur into the oropharynx or the pleural

space. A threatened or at-risk airway is secured with endotracheal intubation. Oral intubation is

attempted first, but in patients with distorted anatomy from direct injury or airway deviation from a

haematoma, a surgical cricothyroidotomy may be needed [30].

Foley Catheter Balloon Tamponade (FCBT)

Active bleeding from a neck wound can present a particular challenge to the healthcare provider.

Bleeding from a deep tract in the neck can be difficult to control with packing or direct digital

pressure and ongoing uncontrollable bleeding from the neck mandates emergent surgical intervention.

One technique that is present in the arsenal of clinicians at most levels of healthcare is the use of a

Foley catheter and inflation of the balloon to create a tamponade effect [32, 33]. Catheter balloon

tamponade is a useful and versatile technique, and although initially described for treating bleeding

oesophageal varices, it is now used in many clinical scenarios where inaccessible life-threatening

haemorrhage poses a challenge [32]. In the trauma setting, balloon tamponade is used, amongst

others, for penetrating cardiac injuries, major inaccessible limb vascular injuries and blunt intra-

abdominal solid organ injuries [32]. Data on its use in penetrating neck injuries is limited in the

current literature. Gilroy et al [34] first described the technique in their 1992 case series from

Baragwanath Hospital. This included 8 patients with major haemorrhage from penetrating neck

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injuries who had balloon tamponade with a Foley’s catheter employed to stop bleeding. In four of

these patients (50%) bleeding was completely arrested.

In 2006, Navsaria et al [33] published a larger series of 18 patients from Groote Schuur Hospital

(GSH). In this series the technique proved much more effective with 17 of the 18 patients having their

bleeding successfully stopped. The authors describe balloon tamponade as a useful resuscitative

technique, thus allowing further diagnostic imaging in these now-stabilised patients. Weppner [35]

went a step further and compared the use of catheter balloon tamponade to direct external pressure for

both penetrating neck and maxillofacial trauma in the military setting. He retrospectively compared

42 patients who had catheter balloon tamponade versus 35 who had only external pressure applied (in

these instances a Foley catheter was simply not available). This retrospective analysis revealed a

statistically significant difference in mortality between the two groups in favour of the Foley catheter

group (5% versus 23%) [35].

The only randomised controlled trial comparing catheter balloon tamponade to direct pressure is a

cadaver-based study by McKee et al [36]. This study compared the use of direct pressure, FCBT and

the use of the iTClamp (a commercial device to arrest bleeding) in 3 separate cadavers with simulated

penetrating neck injuries. The study showed that both FCBT and iTClamp were associated with

significantly less fluid loss (the primary outcome measure used as a surrogate for blood loss)

compared to direct manual pressure. The authors conclude that FCBT and the iTClamp were equally

effective but more effective than simple direct manual pressure [36]. The iTClamp was though both

easier and quicker to apply than a Foley catheter.

Series of PNI that included data on FCBT are tabulated in Table 4. These highlight how uncommonly

the technique is used, but also the paucity of data on FCBT in the current literature. The study by

Weppner [35] represents somewhat of an outlier as the rate of FCBT used was significantly higher

than in any other study (27.1%). This is perhaps explained by the fact that this study comes from the

military setting where the austere environment commonly forces the use of temporising measures

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such as FCBT and the much higher rate of high-velocity projectiles, compared to the low-velocity

injuries in the civilian setting. Of note also is the high rate of bleeding on catheter removal noted in

the Madsen et al [20] study. In all 8 cases (72.7%) where rebleeding was noted, the catheter was

removed soon after insertion (ranging from 0.5 – 28 hours), unlike the longer 48-hour time period

recommended by Navsaria et al [33].

Study Military (M)

/Civilian(C)

Total PNI

patients

% Needing

FCBT

FCBT Initial

Success Rate %

Bleeding on Catheter

Removal

Gilroy et al (1992) [34] C 56 8 (14.3%) 4/8 (50%) NM

Navsaria et al (2006) [33] C 220 18 (8.2%) 17/18 (94.4%) 1/14 (7.1%)

Weppner (2013) [35] M 155 42 (27.1%) 40/42 (95.2%) NM

Teixiera et al (2016) [17] C 161 1 (0.6%) 1/1 (100%) NM

Madsen et al (2018) [21] C 817 11 (1.3%) 8/11 (72.7%) 8/11 (72.7%)

Table 4. Comparison of recent PNI reports that include FCBT. NM = not mentioned.

The usual technique of Foley catheter tamponade involves the insertion of an 18-20 Fr Foley catheter

into the actively bleeding neck wound. This is done gently, without causing iatrogenic injury or

creating new tracts [31]. The catheter bulb is inflated with water until resistance is felt and the

catheter is clamped or knotted on itself [31] (Figure 2). The neck wound around the catheter is

sutured to prevent expulsion of the balloon. More than one catheter may be required to arrest the

haemorrhage. If the technique fails to control the bleeding, the patient is expedited to theatre for

surgical exploration. If, however, the technique is successful and bleeding has stopped, mandatory CT

angiography is performed. If this confirms an arterial injury, definitive management is undertaken via

endovascular or open surgical techniques [31]. If a venous injury or no vascular injury is seen on CT

angiography, the patient is admitted to the ward for serial neck examinations [31]. After 48 hours the

catheter is deflated in theatre and if no bleeding occurs after 5 minutes it is removed. If bleeding

occurs, formal surgical exploration is warranted [31].

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FCBT may have significant implications in those patients presenting with “hard signs” of vascular

injury who actually have relatively minor injuries and thus avoid the need for surgical neck

exploration. It can be used at all levels of care, including the pre-hospital setting, where it may help to

control or slow-down bleeding during transport and may have potential use in mass casualty

situations. The technique of using a Foley catheter balloon to stop bleeding from a penetrating neck

wound is thus described as easy-to-use, with readily-accessible equipment, and effective with a

success rate of >90% [33]. The current Groote Schuur Hospital departmental management algorithm

for using FCBT in PNI is outlined below [31].

Figure 2. Technique of Foley catheter insertion for penetrating neck injury

(taken from Von Waes et al. Management of penetrating neck injuries [23])

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Figure 3 – Algorithm for Foley catheter balloon tamponade in penetrating neck injury [31].

CT = computerised tomography, FC = Foley catheter, OR = operating room. Ancillary tests: water-

soluble contrast, panendoscopy.

Foley catheter into bleeding neck wound

Successful

CT angiography

Ancillary tests

CT angiography (-)

Ancillary tests (-)

Observe 48 hours

Remove FC in OR

Successful

Observe 24 hrs and discharge

Unsuccessful

Surgery

CT angiography (+)

& / or

Ancillary test (+)

Surgery

Unsuccessful

Surgery

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Definitive Management of Vascular Injuries

Penetrating neck injuries resulting in major arterial injuries are associated with significant morbidity

and mortality [37]. In fact, untreated carotid artery injuries have an associated mortality rate

approaching 100% [37]. Of the multiple vessels at risk from a penetrating neck injury, the carotid

arteries are the most commonly injured and reported [37 – 39]. Patients with penetrating carotid

injuries will present with a range of clinical signs, from active external bleeding with haemodynamic

instability to the occult carotid injury with no clinical signs at all [34]. Most authors will advocate that

any injury found either intra-operatively or on pre-operative imaging should be repaired [39]. Choices

for repair of the injured carotid artery include primary repair (arteriorrhaphy or end-to-end

anastomosis) or the use of a conduit such as the great saphenous vein (either as a patch or in-

continuity) or prosthetic grafts [38]. Some authors suggest that minor penetrating injuries, such as

small pseudoaneurysms or dissections can be managed as for blunt carotid injuries, which often

require antithrombotic therapy and follow-up with no surgical intervention needed [37, 38]. However,

due to the concerns that minor injuries can progress to large pseudoaneurysm formation or

thromboembolic events, non-operative management of penetrating carotid artery injuries remains

controversial.

Perhaps the biggest controversy exists around the question of repair versus ligation of carotid injuries.

Management of external carotid artery injuries is less controversial and most authors treat these

injuries by ligation [33, 35], but most case series reveal significant neurological sequelae of

common/internal carotid artery ligation. In most instances surgical repair is warranted. The

controversy lies in patients with carotid injuries who present with already-established central

neurological defects. In the past the main concern with re-establishing blood flow through the carotid

artery in this setting, is that outcomes can be significantly worsened due to conversion to cerebral

haemorrhage. However, large autopsy series looking at this have shown that haemorrhagic strokes

represent the minority of mortality cases and that cerebral oedema is the much more prevalent cause

of death [39]. In their case series of 32 patients with penetrating carotid artery injuries, Navsaria et al

[39], chose to ligate common or internal carotid injuries in patients with proven cerebral infarction or

25

oedema on CT brain, presence of prolonged coma, absence of backflow at surgery, arterial occlusion

on angiography or in high internal carotid artery injuries which are technically difficult to repair.

Importantly, although presence of coma is often considered a contraindication to carotid

revascularisation, Navsaria et al on review of the literature highlight the fact that patients presenting

soon after injury may have other causes for a reduced level of consciousness and thus carotid repair

with reconstitution of blood flow may represent the best way to improve outcome for these patients

[39].

The use of temporary vascular shunts to treat these injuries is also somewhat controversial. There

seems to be little evidence to support its use. Reva et al [40], showed that in their case series of 47

patients, mortality and neurological sequelae were not decreased by using a temporary vascular shunt,

which was used in a total of 8 patients and thus do not advocate for its use.

Endovascular management of vascular injuries seems to be gaining popularity and this is also true of

penetrating neck injuries [41]. Proposed advantages over open procedures include its use in vessels

that are technically difficult to access with open surgery (thus avoiding median sternotomy or

mandibular dislocation), the ability to perform the procedure under local anaesthesia thus allowing for

neurological monitoring during the procedure, and in some centres endovascular techniques are used

as adjuncts to open surgery – a hybrid approach where proximal control is achieved by endovascular

techniques [41]. Arteries that are considered especially difficult to access through open surgery

include the subclavian artery, the vertebral artery, the proximal common carotid artery and the distal

internal carotid artery.

Subclavian artery injuries, especially pseudoaneurysms, are amenable to endovascular repair. In their

Western Trauma Association multicentre review, Waller et al [42], showed that 22% of patients with

subclavian artery injuries were definitively managed by endovascular techniques. Naidoo et al [43],

published a large case series from Groote Schuur Hospital of 31 patients with penetrating subclavian

or axillary artery injuries that were managed with endovascular stent-graft placement. They showed

26

an 84% primary technical success rate with a 90% overall stent-graft patency rate. This study

highlights the efficacy and safety of endovascular management of subclavian arterial injuries in well

selected patients [43].

Endovascular management of carotid artery injuries is now also gaining popularity, with multiple case

reports and series emerging in the literature. One of the largest series comes from South Africa. In

their series of 19 patients from Tygerberg Hospital with penetrating carotid artery injuries managed

endovascularly, Du Toit et al [44], highlight the success of the technique. Their patient selection

included mainly those patients representing difficult access injuries, notably proximal common

carotid and distal internal carotid artery injuries. In this series of well-selected cases, technical success

was 100% and outcomes showed only one death in the group (due to cerebral oedema) and one stroke.

The authors go on to advocate the use of endovascular management of these injuries [44].

Conclusion

Penetrating neck injuries remain an important clinical entity in trauma. Vascular injuries represent the

most life-threatening initial concern after the airway has been secured and management of these

important injuries is constantly evolving. Selective non-operative management is now considered

standard of care in most institutions. Increasing use of CT angiography is reducing the need for formal

diagnostic angiography, but conversely interventional endovascular techniques seem to be gaining

popularity. Simple techniques like Foley catheter balloon tamponade can help stabilise patients to

allow for further investigation and direct management decisions, however data on the use of balloon

tamponade for bleeding neck injuries is limited and further research is needed in this field.

27

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31

PUBLICATION READY MANUSCRIPT

INTRODUCTION

The use of a Foley catheter balloon to tamponade a penetrating neck wound is a well-recognised

strategy used to temporarily arrest catastrophic bleeding. We reported our experience with this

technique in 2006 and proposed an institutional management algorithm [1]. Since then civilian reports

of the success of this life-saving procedure have been few, thus underscoring its infrequent need

(Table 1). As a follow-up we now report on a larger cohort of patients managed with Foley catheter

balloon tamponade (FCBT) for penetrating neck injuries and attempt to validate the previously

proposed algorithm.

METHODS

The trauma unit at Groote Schuur Hospital (GSH) is a level one urban trauma centre with a high

incidence of penetrating trauma. The protocol for the treatment of penetrating neck injuries is one of

selective nonoperative management. For the period of December 2015 to September 2017 (22

months) adult patients presenting with a penetrating neck injury in whom FCBT was used to arrest

haemorrhage, were retrospectively identified from an established prospective penetrating neck injury

database. Data included patient demographics, mechanism of injury, admission vital signs, neck zone

injured, investigations, management and major outcomes. Injury severity was categorised according

to the Revised Trauma Score (RTS), Injury Severity Score (ISS), Trauma and Injury Severity Score

(TRISS) and New Injury Severity Score (NISS). Specific data on the use of FCBT included the

designation of the facility (level of care) at which the catheter was placed, the number of catheters

deployed in each patient and the success rate at arresting haemorrhage. Visceral and vascular injuries

were identified either at surgery and/or on computerised tomography angiography (CTA) and/or

ancillary tests. Complications related to the insertion of the catheter or its removal were documented.

Basic descriptive statistical analysis was performed using functions available in Microsoft Excel©.

32

This study had full ethics approval from the University of Cape Town Human Research Ethics

Committee (HREC) and institutional approval from Groote Schuur Hospital.

Patients presenting with bleeding penetrating neck injuries were resuscitated along Advanced Trauma

Life Support (ATLS) guidelines and managed as per the Groote Schuur Hospital institutional

algorithm for the use of FCBT for bleeding neck injuries (Figure 1).

An 18G or 20G Foley catheter (FC) was placed into the penetrating neck wound and along the injury

tract. The balloon of the catheter was inflated until resistance was felt and the catheter was then either

knotted on itself or clamped to stop back-bleeding. More than one catheter could be utilised (Figure

2). The neck wound was sutured around the catheter to prevent expulsion. Failed FCBT was an

indication to proceed to emergent surgery. Patients in whom haemorrhage was successfully stopped

using FCBT underwent CTA and further ancillary tests as indicated. This included formal catheter-

directed angiography for equivocal CTA findings or for endovascular intervention, gastrointestinal

endoscopy and/or contrasted swallow examination for suspected pharyngo-oesophageal injuries.

Patients were monitored in a high-care unit with close monitoring and neck observations. After 48

hours, removal of the FC was attempted in the operating room. Anaesthesia and operating room staff

were available to proceed to surgery in the event of bleeding. The balloon was deflated, and after 5

minutes, the catheter was slowly withdrawn. Bleeding at any stage of the procedure warranted

induction of general anaesthesia and neck exploration. After successful removal of the catheter, the

wound was irrigated, cleaned and closed with interrupted non-absorbable sutures and the patient

discharged after a further 24-hour observation period.

33

RESULTS

Over the 22-month study period a total of 628 patients presented to GSH with a PNI (average of 28.5

PNI patients/month), of which 95 patients (15.2%) required the use of FCBT. In the remaining 533

patients who did not require FCBT, only 6 (0.96%) were expedited directly to theatre without

appropriate imaging first. The remaining 527 were admitted and either observed clinically without

further imaging (147 patients) or underwent further imaging (380 patients).

Of the cohort of 95 FCBT patients, 93 were men (97.9%) with an average age of 27.9 years (+/- 7.8

years, range of 18 – 48 years, interquartile range [IQR] 22 – 32 years). The mechanism of injury was

predominantly stabbings (86 patients [90.5%]), while 9 patients (9.5%) sustained low-velocity

gunshot wounds to the neck. In the cohort of all 628 PNI patients the mechanism of injury included

484 (77.1%) stabbings (this included mainly knife stabbings, but also screwdrivers and broken glass),

111 (17.7%) gunshot wounds, and 33 (5.3%) other or unknown mechanism of injury (including 4

cases of axe/machete injuries, 2 dog bites, impalement on an iron fencepole, use of a garden spade,

and an angle grinder injury).

Zone II was the most commonly injured neck zone (34.7%), 11.6% of patients were hypotensive

(systolic blood pressure < 90mmHg) and 15.8% had a Glasgow Coma Score of less than 8 on arrival.

The average Injury Severity Score (ISS) on admission was 11.14 with 26.3% of patients having an

ISS >15 on admission (Table 2).

FCBT Details

Details of the level of care where these catheters were placed, the number of catheters that were

needed in each patient and the problems associated with the use of FCBT are outlined in Tables 3 and

4. Almost half of these catheters were inserted either in the prehospital or clinic level. In almost all

patients one or two catheters were sufficient to arrest haemorrhage, although 2 patients required more

than 2 catheters to achieve haemostatic control. There were some instances where catheters fell out

34

en-route to our centre either by accidental removal or the balloon not being inflated. In one instance,

the catheter was noted to lie too shallow in the injury tract with ongoing bleeding. The bleeding was

successfully aborted with removal of the in-situ catheter and replacement with another catheter placed

deeper into the tract. Of the 95 patients, bleeding was successfully arrested in 92 patients (96.8%).

Only three patients (3.2%) had ongoing bleeding despite the correct placement of the Foley

catheter(s). One of these patients demised in the trauma resuscitation room due to advanced shock and

the other two were successfully expedited to theatre. One of these patients had a subclavian vein

injury while the other had injuries to the thyrocervical trunk, anterior and internal jugular veins. Two

patients had bleeding at the time of catheter removal in theatre (see below).

Investigations

Of the total 95 patients, 88 (92.6%) had computerised tomography angiography (CTA) performed,

while the remaining 7 patients who did not have a CTA included 2 patients who were expedited

directly to theatre with ongoing active bleeding, 2 patients who died in the trauma resuscitation room

shortly after arrival and 3 patients where the catheter had been accidentally dislodged and had no

further major vascular signs and were thus successfully clinically observed. Only 8 patients (8.4%)

required formal digital subtraction angiography, of which 2 were purely diagnostic for equivocal CTA

findings and the remaining 6 required endovascular intervention (Figure 3). A total of 32 patients

(33.7%) with suspicion of concomitant aerodigestive tract injuries were investigated with a water-

soluble contrast swallow study and 9 patients (9.5%) went on to have some form of aerodigestive tract

endoscopy (laryngopharyngoscopy, oesophagoscopy or bronchoscopy).

Confirmed Vascular Injuries

A total of 29 patients (30.5%) had an arterial injury, which included a total of 19 major arteries in 15

patients and a further 15 minor arterial injuries (one of these patients had both a major and minor

arterial injury). In 23 patients, a total of 26 separate venous injuries were confirmed on CTA or intra-

operatively. Twelve patients (12.6%) had both arterial and venous injuries. Importantly, a further 18

patients had visible abnormalities in the major neck veins on the venous phase of the CTA, of which 3

35

were reported to be likely artefactual or due to phasing issues, while the remaining 15 where reported

as possible venous injuries. Seven aerodigestive tract injuries were observed in this cohort, including

1 tracheal injury and 6 pharyngeal injuries. Figure 4 shows a breakdown of patients with arterial and

venous injuries and Table 5 shows specific arterial and venous injuries.

Management

A total of 27 patients (28.4%) had airway compromise after their initial injury, of which 25 patients

(26.3%) were successfully managed with oral endotracheal intubation while the other 2 patients

(2.1%) required surgical cricothyroidotomy. Blood transfusion was needed in 27 patients (28.4%) and

4 of these patients met the criteria for massive blood transfusion. A total of 13 patients underwent

surgical neck exploration for vascular injuries. Procedures performed included 9 arterial repairs (6

arteries repaired primarily, 2 repairs with venous grafts and 1 with synthetic graft), and 3 arterial

injuries managed with ligation of the artery (vertebral artery, external carotid artery and thyrocervical

trunk). Six patients were managed with endovascular techniques, including endovascular stenting of 4

subclavian artery injuries (all subclavian artery injuries in this study were managed endovascularly)

and endovascular coiling of pseudoaneurysms of the vertebral artery and thyrocervical trunk. Of the

total 26 documented venous injuries, 9 were managed operatively with 2 primary repairs (both

internal jugular veins) and ligation of a further 7 venous injuries. In 8 of these injuries a concomitant

arterial or aerodigestive tract injury was found and surgically managed, while only one patient had an

isolated venous injury needing surgery. The remaining 17 confirmed venous injuries were

successfully managed without the need for vascular operative intervention.

Removal of the Foley’s catheter was performed during the initial vascular procedure in these 13

patients needing surgical exploration, while a further 72 patients had their Foley catheter(s) removed

in the operating room as a separate, delayed procedure at 48 hours post injury. In 70 of these 72

patients (97.2%) no bleeding was encountered on removal of the catheter while 2 patients had

bleeding noted from the wound. One of these patients had a superficial venous branch of the external

jugular vein identified as the source of the bleeding, which was ligated. The other patient had venous

36

bleeding from deep within the wound and injury from the subclavian vein was thought to be the

source. Due to difficult surgical access, the decision was made to re-insert the Foleys catheter and re-

inflate the balloon. This successfully stopped the bleeding and the catheter was then successfully

removed without any further bleeding 48 hours later. In 10 patients the catheter was not removed in

theatre has it had either been accidentally dislodged or the patient died (n = 4) with the catheter still

in-situ.

Outcomes

The median length of hospital stay for the patient cohort was 4 days (+/- 12.6 days, range <1 day to

116 days, IQR: 2 – 6 days). This was skewed by numerous patients requiring prolonged

hospitalisation for multiple other injuries. One patient suffered a cervical spinal cord injury with

quadriplegia and ultimately spent 116 days in hospital. A total of 15 patients (15.8%) required

admission to the intensive care unit. Twenty-eight patients (29.5%) had a total of 36 separate

morbidities which are listed in Table 6. In the 4 patients suffering cardiac arrest where

cardiopulmonary resuscitation was attempted, two patients ultimately survived and two demised.

There were 4 deaths equating to a mortality rate of 4.2% in this cohort. One of these patients had

evidence of raised intracranial pressure from a large middle cerebral artery territory infarct from a

common carotid injury, had no ongoing haemorrhage from the neck wound and was deemed

neurologically unsalvageable on arrival. The second patient sustained gunshot wounds to both the

neck and head (transcranial) and was essentially braindead on arrival (this mortality was attributed to

the head injury and not the neck injury). The third mortality was a delayed referral, initially managed

at a secondary hospital. The patient was well on initial presentation, but re-presented to the hospital a

week post injury with renewed bleeding from the neck wound (prompting FCBT), focal neurological

signs and systemic sepsis. Imaging revealed missed common carotid artery and vertebral artery

injuries and features of cerebral infarction, which prompted referral to GSH. At GSH no further

bleeding was noted, but the patient demised shortly after arrival despite resuscitation efforts. The

cause of death was deemed a combination of sepsis and cerebral infarction and not from

exsanguinating haemorrhage. The last patient had a history of active bleeding at the referral clinic

37

which was controlled with pressure and skin closure (no FCBT used initially). Bleeding restarted en-

route in the ambulance and on arrival to GSH the patient was in extremis, with profound hypotension,

hypothermia, acidosis and coagulopathy. FCBT was attempted at GSH, but the patient demised

shortly after arrival.

38

DISCUSSION

There is limited data on the use and success rate of FCBT for PNI. Even less is known about the rate

of bleeding encountered when the catheters are removed. Gilroy et al [2] and Navsaria et al [1] both

highlight that venous injuries respond well to balloon tamponade for haemorrhage control and FCBT

may thus represent a form of definitive management in these patients. FCBT is superior to direct

digital pressure at stopping bleeding and may reduce mortality [3, 7]. When successful, the technique

allows patients to be resuscitated, stabilised, and appropriately imaged. Further management planning,

which may include immediate intervention or admission for observation followed by removal of the

catheter, can be instituted. When vascular intervention is required, open surgery can be planned in a

more controlled manner, with the further option of endovascular repair.

This series reports what we believe to be the largest patient cohort utilising FCBT in PNI and thus

allows for analysis of this simple, easy and accessible haemostatic technique. In this series of 628 PNI

patients, FCBT was attempted in 95 (15.2%) patients, achieving haemostasis with haemodynamic

stabilisation in 92 (96.8%) patients, illustrating its efficacy. With roll-out of our institutional

algorithm since our last report in 2006, there is an almost two-fold increase in the use of the technique

(8% vs 15%) [1].

Demographics in this cohort are similar to most case series on penetrating neck injuries from South

Africa and internationally, with the majority of patients being male with an average age under 30

years. The mechanism of injury was predominantly knife stabbings, with 9 patients with gunshot

wounds. Compared to the entire cohort of PNI patients, those patients where FCBT was used had

slightly less gunshot wounds.

Just under half of patients in this cohort had the catheter(s) inserted at either clinic or pre-hospital

level care. This further highlights the ease of access and simplicity of the technique, with success

possible even in the somewhat uncontrolled environment of the prehospital setting, such as in an

39

ambulance during transfer. Foley catheters are available in almost all healthcare settings and require

no special equipment or formal training to be successfully used to tamponade neck bleeding.

Although a single catheter suffices to control bleeding in most cases, if bleeding persists two or more

catheters may well be successful at arresting haemorrhage.

In our institution FCBT is an indication for specialised vascular imaging in the form of a CTA. A total

of 34 arterial injuries were identified in 29 patients (30.5%). Of these, 12 were managed with open

surgery and a further 6 were managed endovascularly (Figure 3). Thirteen minor arterial injuries seen

on CTA were managed with no further intervention. FCBT thus represents a form of definitive

management for these minor arterial injuries. A further three major arterial injuries were identified on

CTA in 2 patients (one patient with a common carotid artery injury only and one patient with both

common carotid and vertebral artery injuries), both of whom died from massive cerebral infarcts.

A total of 26 venous injuries were identified in 23 patients (24.2%). Of these, 9 were managed with

surgery. One required emergency surgery without preoperative imaging for continued bleeding from a

subclavian vein injury. A further 8 venous injuries were operatively managed with either repair or

ligation, but formed part of the surgery done for concomitant arterial or aerodigestive tract injuries. In

none of these 8 cases was the venous injury the primary indication for surgery. The remaining 14

patients did not require surgery for the confirmed venous injuries on CTA and were successfully

managed non-operatively. FCBT thus further represents a form of definitive management for these

venous injuries.

Patients with a negative CTA, or one that confirms a minor arterial or venous injury, and negative

ancillary tests, are observed for a period of 48 hours: the first 24 hours form part of the penetrating

neck injury protocol, where the patient is kept nil per mouth and observed for development of hard

signs of a vascular or aerodigestive tract injury; the next 24 hours the patient is fed and observed for

development of hard signs of a vascular or aerodigestive tract injury. The catheter is then removed

under controlled conditions in the operating room.

40

Foley catheters were removed in 72 patients after this period of observation. In two patients bleeding

was encountered either on deflation of the bulb or removal of the catheter. One patient was explored

and a small muscular venous vessel was ligated. In the other patient, the catheter was reinserted with

success. On review of the CTA intra-operatively a subclavian vein injury was suspected. It was

decided not to proceed with exploration. The catheter was successfully removed a further 48 hours

later. This rebleeding rate of 2.8% following removal of the catheter shows an improvement from the

previously reported 7% from our institution [1].

Madsen et al [5] report a rebleeding rate of >70% following catheter removal. In 8 of their 11 patients

who needed FCBT, the catheter was removed at 28 hours or less after insertion and in 5 patients the

catheters were removed within 10 hours. In only 3 patients was no bleeding encountered on removal

and in all three the catheter was kept in for longer than 24 hours. These findings thus support our

policy of waiting at least 48 hours before catheter removal is attempted.

41

CONCLUSION

This large series on FCBT for PNI highlights this technique in its simplicity and effectiveness at

controlling bleeding. Foley catheters are readily available at all levels of care. It allows for

stabilisation of seriously injured patients who can be appropriately imaged and managed in a more

planned and controlled manner. The technique can be used as a definitive form of management in

well-selected cases with venous or minor arterial injuries in the neck. However, it is prudent to wait

48 hours before catheter removal is attempted in those patients not requiring initial management of

major arterial injuries. We advocate for the role of FCBT in PNI because it is accessible, easy-to-use

and ultimately highly effective.

42

List of Tables

Table 1. Recent PNI reports that include FCBT

Table 2. Admission vital signs an injury severity scores in 95 patients

Table 3. Facility designation and number of catheters placed per patient.

Table 4. Foley Catheter Placement Complications

Table 5. Vascular injuries identified

Table 6. Overall Morbidities

Study Military (M)/

Civilian(C)

Total PNI

patients

% Needing

FCBT

FCBT Initial Success

Rate

Bleeding on Catheter

Removal

Gilroy et al (1992) [2] C 56 8 (14.3%) 4/8 (50%) NM

Navsaria et al (2006) [1] C 220 18 (8.2%) 17/18 (94.4%) 1/14 (7.1%)

Weppner (2013) [3] M 155 42 (27.1%) 40/42 (95.2%) NM

Teixiera et al (2016) [4] C 161 1 (0.6%) 1/1 (100%) NM

Madsen et al (2018) [5] C 817 11 (1.3%) 8/11 (72.7%) 8/11 (72.7%)

Table 1. Recent PNI reports that include FCBT. NM = not mentioned.

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Admission Findings

Neck Zone Injured

- Zone I 21 (22.1%)

- Zone II 33 (34.7%)

- Zone III 10 (10.5%)

- Posterior 17 (17.9%)

- Multiple Zones 14 (14.7%)

Admission Systolic Blood Pressure

- < 90mmHg 11 (11.6%)

- > 90mmHg 84 (88.4%)

Admission Glasgow Coma Scale (GCS)

- GCS 15 67 (70.5%)

- GCS 13-14 3 (3.2%)

- GCS 8-12 10 (10.5%)

- GCS <8 15 (15.8%)

Admission Trauma Severity Scores

ISS

- ISS Average 11.14

- ISS < 10 56 (58.9%)

- ISS 10 – 15 14 (14.7%)

- ISS >15 25 (26.3%)

RTS

- RTS > 4 90 (94.7%)

- RTS < 4 5 (5.3%)

NISS

- Average NISS 12.21

- NISS < 10 52 (54.7%)

- NISS 10 – 15 16 16.8%)

- NISS > 15 27 (28.4%)

TRISS

- TRISS < 50% chance of survival: 7 (7.4%)

- TRISS 50 – 90% chance of survival: 10 (10.5%)

- TRISS 90 – 99% chance of survival: 23 (24.2%)

- TRISS >99% chance of survival: 55 (57.9%)

Table 2. Admission vital signs an injury severity scores in 95 patients. ISS = Injury Severity Score,

RTS = Revised Trauma Score, NISS = New Injury Severity Score, TRISS = Trauma and Injury

Severity Score.

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Catheter Placement Number of Patients

Level of Care where Catheter was Placed

- Prehospital (Ambulance) 1 (1.1%)

- Primary Level (Clinic) 43 (45.3%)

- Secondary Level (District Hospital) 33 (34.7%)

- Tertiary Level (GSH) 18 (18.9%)

Number of Catheters Needed in Each Patient

- One catheter 80 (84.2%)

- Two catheters 13 (13.7%)

- Three catheters 1 (1.1%)

- Four catheters 1 (1.1%)

Table 3. Facility designation and number of catheters placed per patient.

Foley Catheter Placement Complications Number of Patients

Catheter fell out accidentally (none with subsequent bleeding) 5 (5.2%)

Ongoing bleeding despite correct FCBT 3 (3.2%)

Balloon not inflated/not inflated enough 3 (3.2%)

Catheter lying too shallow (with initial bleeding) 1 (1.1%)

Catheter inserted into wrong tract/wound 1 (1.1%)

Bleeding at time of catheter removal in theatre 2 (2.1%)

Table 4. Foley Catheter Placement Complications

Table 5. Vascular injuries identified

Major Arterial Injury No. Minor Arterial Injury No. Venous Injury No.

Common carotid artery 8 Thyrocervical trunk 4 Internal jugular vein 13

Internal carotid artery 1 Thyroid arteries 3 External jugular vein 4

External carotid artery 1 Lingual 2 Subclavian vein 2

Vertebral artery 3 Facial 1 Brachiocephalic vein 2

Subclavian artery 4 Suprascapular 1 Other/minor veins 5

Brachiocephalic artery 2 Other/unnamed vessels 4

Total 19 Total 15 Total 26

45

Specified Morbidity Number

Wound site infection 8

Cerebrovascular accident/Stroke 5

Pneumonia/Empyema 5

Massive blood transfusion 4

Cardiac arrest needing cardiopulmonary resuscitation 4

Missed injury (subclavian vein) 1

Prolonged pharyngeal leak/Pharyngocutaneous fistula 2

Other* 7

Table 6. Overall Morbidities (*Other [one each]: urinary tract infection, thrombophlebitis, sacral

decubitus ulcer, quadriplegia, chylothorax, infective diarrhoea [suspected C. difficile infection], limb

compartment syndrome [unrelated to PNI])

46

List of Figures

Figure 1. Algorithm for Foley catheter balloon tamponade in penetrating neck injury

Figure 2. Photograph of patient with left neck stab wound who required the insertion of 4 Foley

catheters to arrest active bleeding.

Figure 3. Successful FCBT for actively bleeding right-sided zone I neck stab with subclavian artery

injury.

Figure 4. Summary of Arterial and Venous Injuries

47

Figure 1. Algorithm for Foley catheter balloon tamponade in penetrating neck injury [6]. CT =

computerised tomography, FC = Foley catheter, OR = operating room. Ancillary tests: water-soluble

contrast, panendoscopy.

Foley catheter into bleeding neck wound

Successful

CT angiography

Ancillary tests

CT angiography (-)

Ancillary tests (-)

Observe 48 hours

Remove FC in OR

Successful

Observe 24 hrs and discharge

Unsuccessful

Surgery

CT angiography (+)

& / or

Ancillary test (+)

Surgery

Unsuccessful

Surgery

48

Figure 2. Image of patient with left zone I stab wound requiring the insertion of 4 Foley catheters to

arrest bleeding (courtesy of corresponding author).

49

Figure 3. Successful FCBT for bleeding right-sided zone I neck stab wound. a.) Coronal view of CTA

showing inflated Foley catheter balloon within stab tract (arrow) b.) Coronal view of CTA showing

subclavian artery pseudoaneurysm (arrow) c.) Digital subtraction angiogram (DSA) image confirming

right subclavian artery pseudoaneurysm (arrow) d.) DSA image post stent-graft placement showing

resolution of the pseudoaneurysm.

a b

c d

50

Figure 4. Summary of Arterial and Venous Injuries

Total:

95 FCBT Patients

Arterial Injuries (no venous injuries):

17 patients (17.9%)

Venous Injuries (no arterial injuries):

11 Patients (11.6%)

Combined Arterial and Venous Injuries:

12 Patients (12.6%)

Equivocal CTA Venous Findings:

15 Patients (15.8%)

No Vascular Injuries:

40 Patients (42.1%)

51

REFERENCES

1.) Navsaria P, Thoma M, Nicol A (2006) Foley Catheter Balloon Tamponade for Life-threatening

Hemorrhage in Penetrating Neck Trauma. World J Surg 30: 1265–1268

2.) Gilroy D, Lakhoo M, Charalambides D, Demetriades D (1992) Control of life-threatening

haemorrhage from the neck: a new indication for balloon tamponade. Injury 23(8):557

3.) Weppner J (2013) Improved mortality from penetrating neck and maxillofacial trauma using Foley

catheter balloon tamponade in combat. J Trauma Acute Care Surg 75(2):220-4

4.) Teixeira F, Menegozzo CAM, Netto SDDC, et al (2016) Safety in selective surgical exploration in

penetrating neck trauma. World J Emerg Surg 11:32

5.) Madsen AS, Bruce JL, Oosthuizen GV, et al (2018) The Selective Non-operative Management of

Penetrating Cervical Venous Trauma is Safe and Effective. World J Surg 42:3202-3209

6.) Navsaria PN. Chapter 4: Head and Neck Hemorrhage: What Do I Do Now? (2018) In: Treatment

of Ongoing Bleeding: The Art and Craft of Stopping Severe Bleeding. Springer International

Publishing, p. 45 – 54

7.) McKee JL, Mckee IA, Bouclin MD, et al (2019) A randomized controlled trial using iTClamp,

direct pressure, and balloon catheter tamponade to control neck haemorrhage in a perfused human

cadaver model. J of Emerg Med 56(4): 363-370

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APPENDICES Appendix 1: Ethics Approval – University of Cape Town Human Research Ethics Committee

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Appendix 2: Intended Journal for Publication - World Journal of Surgery: Submission Instructions to

Authors.

54