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\begin{document}

\title{Safety of surgical tracheostomy under continued antithrombotic therapy}



\author[1]{Takayuki Sugaya}%
\author[1]{Rumi Ueha}%
\author[1]{Taku Sato}%
\author[1]{Takao Goto}%
\author[1]{Akihito Yamauchi}%
\author[1]{Tatsuya Yamasoba}%
\affil[1]{The University of Tokyo}%


\vspace{-1em}



  
  \date{June 12, 2024}


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\selectlanguage{english}
\begin{abstract}
Abstract Objective: Although various guidelines have been established
for the management of antithrombotic therapy during surgical treatments,
surgical tracheostomy (ST) under continued antithrombotic therapy (CAT)
remains a challenge. We investigated the risk factors for complications
after ST by focusing on CAT use during ST. Method: Patients' medical
records from 2009 to 2020 were reviewed in this retrospective study. We
selected patients who underwent ST at the Department of Otolaryngology
of the University of Tokyo Hospital. Patient demographics,
complications, and blood test values were recorded and statistically
analyzed to identify the risk factors for postoperative complications.
Results: We identified 288 patients (median age: 64 years; 184 men
{[}64\%{]}), among whom 40 (median age: 67 years; 29 men {[}73\%{]})
underwent CAT. Although the patients undergoing CAT had significantly
higher values of activated partial thromboplastin time (p = 0.002) and
prothrombin time-international normalized ratio (p = 0.006) than those
of antithrombotic na\selectlanguage{ngerman}ïve patients, no statistically significant
intergroup differences were observed in the risks of bleeding,
infection, or subcutaneous emphysema. Instead, ST under local anesthesia
(p = 0.01) and ST for airway emergency (p = 0.02) significantly
increased the risk of early postoperative complications. Conclusion: The
results of the present study suggest that ST under CAT can be safely
performed without any increased risk of postoperative complications.
Nevertheless, surgeons should be extra cautious about early
complications after ST under local anesthesia without intubation or ST
for airway emergency. Key points: 1. We aimed to investigate the risk
factors for complications after ST by focusing on CAT use during ST. 2.
Patients undergoing CAT had significantly higher values of APTT and
PT-INR than those of antithrombotic naïve patients. 3. ST under CAT can
be safely performed without any increased risk of postoperative
complications. 4. ST under local anesthesia and airway emergency was a
risk factor for complications after ST. 5. Among the complications,
subcutaneous emphysema was significantly more frequent in ST under local
anesthesia and under airway emergency.%
\end{abstract}\selectlanguage{ngerman}%



\sloppy


\textbf{Abstract}

\textbf{Objective} : Although various guidelines have been established
for the management of antithrombotic therapy during surgical treatments,
surgical tracheostomy (ST) under continued antithrombotic therapy (CAT)
remains a challenge. We investigated the risk factors for complications
after ST by focusing on CAT use during ST.

\textbf{Method} : Patients' medical records from 2009 to 2020 were
reviewed in this retrospective study. We selected patients who underwent
ST at the Department of Otolaryngology of our hospital. Patient
demographics, complications, and blood test values were recorded and
statistically analyzed to identify the risk factors for postoperative
complications.

\textbf{Results} : We identified 288 patients (median age: 64 years; 184
men {[}64\%{]}), among whom 40 (median age: 67 years; 29 men {[}73\%{]})
underwent CAT. Although the patients undergoing CAT had significantly
higher values of activated partial thromboplastin time (p = 0.002) and
prothrombin time-international normalized ratio (p = 0.006) than those
of antithrombotic na\selectlanguage{ngerman}ïve patients, no statistically significant
intergroup differences were observed in the risks of bleeding,
infection, or subcutaneous emphysema. Instead, ST under local anesthesia
(p = 0.01) and ST for airway emergency (p = 0.02) significantly
increased the risk of early postoperative complications.

\textbf{Conclusion} : The results of the present study suggest that ST
under CAT can be safely performed without any increased risk of
postoperative complications. Nevertheless, surgeons should be extra
cautious about early complications after ST under local anesthesia
without intubation or ST for airway emergency.

\textbf{Key points} :

1. We aimed to investigate the risk factors for complications after ST
by focusing on CAT use during ST.

2. Patients undergoing CAT had significantly higher values of APTT and
PT-INR than those of antithrombotic naïve patients.

3. ST under CAT can be safely performed without any increased risk of
postoperative complications.

4. ST under local anesthesia and airway emergency was a risk factor for
complications after ST.

5. Among the complications, subcutaneous emphysema was significantly
more frequent in ST under local anesthesia and under airway emergency.

\textbf{1 INTRODUCTION}

Surgical tracheostomy (ST) is one of the most frequently performed
surgical procedures for patients with severe or critical
conditions.\textsuperscript{1} Similar to any other invasive procedure,
ST can result in numerous potential complications. These include early
complications, such as bleeding, subcutaneous emphysema, stomal
infection, and accidental decannulation,\textsuperscript{2} and late
complications, such as airway stenosis, tracheomalacia, tracheocutaneous
fistula, and pneumonia.\textsuperscript{1,2}Postoperative complications
of ST are rare, and the early and late postoperative complication rates
are 5.6\% and 7.1\%, respectively.\textsuperscript{3} Obesity and awake
tracheostomy are major risk factors for postoperative complications of
ST.\textsuperscript{4,5}Further, four or more comorbidities are reported
to increase the risk of postoperative bleeding, which is the most
frequent early complication of ST.\textsuperscript{3,6}Additionally, ST
is sometimes necessary for patients undergoing continued antithrombotic
therapy (CAT), which can exacerbate the risk of bleeding. However, there
is a dearth of data regarding ST under CAT.

Several guidelines recommend that tooth extraction in patients on
antithrombotic therapy can be performed without reducing or
discontinuing antiplatelet or anticoagulant drugs\textsuperscript{7-10}
and that percutaneous endoscopic gastrostomy\textsuperscript{11} and
endoscopic variceal ligation\textsuperscript{12} can be performed
without discontinuing aspirin. However, no established guidelines are
currently available for the management of antithrombotic therapy in
patients undergoing ST. In this study, we investigated the risk factors
for complications after ST by focusing on CAT use during ST.

\textbf{2 MATERIALS AND METHODS}

2.1 Patients and ethics approval

We included patients who underwent ST by otolaryngologists at our
hospital between 2009 and 2020. Patients who underwent percutaneous
tracheostomy were excluded. This study was approved by the Human Ethics
Committee of our hospital. Written informed consent was obtained from
every patient, and patient anonymity was preserved.

2.2 Methodology

We conducted a retrospective, single-center study using medical charts
from the hospital database of our institute. The clinical and
demographic profiles of the patients, including age, sex, and body mass
index; presence of diabetes mellitus (DM), hypertension, primary
diseases, or airway emergency; method of anesthesia (local anesthesia
without intubation or general anesthesia); use of antithrombotic drugs;
presence of complications; blood test values, were analyzed.

Complications were reviewed with respect to the incidences of bleeding,
infection, and subcutaneous emphysema. We defined ``bleeding'' as
bleeding lasting 1 week after ST or bleeding that required surgical
hemostasis; ``infection'' as a condition requiring the application of
antibiotic ointments or surgical treatment, including the excision of
the infected area; ``subcutaneous emphysema'' as the evident presence of
subcutaneous emphysema around the tracheostoma.

Blood test values were reviewed to determine the albumin level,
lymphocyte count, platelet count, prothrombin time (PT), activated
partial thromboplastin time (APTT), and prothrombin time-international
normalized ratio (PT-INR). The abnormal ranges for albumin level,
lymphocyte count, platelet count, PT, APTT, and PT-INR were defined as
\textless{}3.0 g/dL, \textless{}1500/\selectlanguage{greek}μ\selectlanguage{english}L, \textless{}50000/\selectlanguage{greek}μ\selectlanguage{english}L,
\textgreater{}14 s, \textgreater{}40 s, and \textgreater{}1.5,
respectively.

We also extracted the data of patients who underwent ST under CAT.
Thereafter, we compared the patient backgrounds and risks of
complications after ST between the antithrombotic na\selectlanguage{ngerman}ïve patients and
patients undergoing CAT. Furthermore, we analyzed the risk factors for
complications after ST.

2.3 Statistical analyses

We analyzed the data using BellCurve for Excel (version 3.20, Social
Survey Research Information Co., Ltd., Tokyo, Japan). To compare the
antithrombotic naïve patients and patients undergoing CAT to patients
with or without postoperative complications, we used the Mann\selectlanguage{english}-Whitney U
test for continuous variables and Fisher's exact test or chi-square test
for categorical variables. A p value \textless{} 0.05 was considered
statistically significant.

\textbf{3 RESULTS}

3.1 Patient demographics

Table 1 lists the demographic data of the enrolled patients. We
identified 288 eligible patients. Their median age at the time of
tracheostomy was 64 years (interquartile range, 48\selectlanguage{english}-73 years), and there
was a male predominance (64\%). The most common primary diseases were
cerebrovascular and neuromuscular diseases (26\%). The primary reasons
for tracheostomy were long-term intubation (72\%), upper-airway
narrowing (21\%), and difficult intubation (6\%). Among them, 39
patients (14\%) underwent emergency ST. ST was performed under local
anesthesia in 57 patients (19\%). ST under CAT was performed in 40
patients (14\%).

3.2 Effects of antithrombotic use on complications after ST

The background of patients according to their CAT status is summarized
in Table 2. Patients undergoing CAT had significantly higher values of
APTT (p = 0.002) and PT-INR (p = 0.006) than those of antithrombotic
naive patients.

No statistically significant difference was observed in the number of
patients with any complications between patients undergoing CAT (63\%)
and antithrombotic naive patients (73\%). Comparisons of each
postoperative complication (bleeding, infection, and subcutaneous
emphysema) also revealed no significant differences between the two
groups (Table 3).

3.3 Risk factors for clinical complications after ST

Table 4 summarizes the characteristics of patients with or without
complications. Among the 49 patients (17\%) who developed complications
within 7 days after ST, 11 (4\%) had bleeding, 29 (10\%) had infection,
and 16 (3\%) had subcutaneous emphysema. ST under local anesthesia and
ST for airway emergency significantly increased the risk of
complications after ST (p = 0.01 and p = 0.02, respectively). Among the
complications, subcutaneous emphysema was significantly more frequent in
ST under local anesthesia (p \textless{} 0.001) and under airway
emergency (p = 0.049) (Table 5).

\textbf{4 DISCUSSION}

In the present study, we investigated the safety of ST in patients
undergoing CAT and arrived at the following two major results. First, no
significant difference was observed in the incidence of postoperative
complications with or without antithrombotic medication, even though
APTT and PT-INR showed significant differences among these patients.
Second, ST under local anesthesia and airway emergency was a risk factor
for complications after ST.

The literatures contain inconsistent reports regarding the additive risk
of postoperative bleeding with the use of antithrombotic drugs, and this
could presumably be attributed to the differences in surgical
procedures, patient demographics, and degree of antithrombotic
conditions among patients included in the various studies. For instance,
the risk of chronic bleeding after percutaneous dilatational
tracheostomy (PDT) is reportedly higher in the presence of two or more
abnormal coagulation variables,\textsuperscript{13} even though CAT is
not considered a risk factor for bleeding after PDT.\textsuperscript{14}
CAT also increased the frequency of hemorrhagic complications requiring
intervention after prostate biopsy.\textsuperscript{15} In contrast, a
study reported no association between the risk of bleeding after
percutaneous endoscopic gastrostomy and CAT; pulmonary procedures under
CAT did not increase the risk of bleeding either.\textsuperscript{16}
Various reports have also concluded that CAT is not a risk factor for
bleeding after minimally invasive surgeries, such as tooth extraction,
percutaneous endoscopic gastrostomy, and endoscopic variceal
ligation.\textsuperscript{7,11,12}The results of the present study
support these findings and suggest that ST can be safely performed even
under CAT. However, a bias may exist in the differences in the intensity
of hemostasis between ST with or without CAT, because surgeons may have
performed hemostatic procedures more carefully in ST under CAT to
prevent intraoperative and postoperative bleeding.

Based on the present results, we recommend that surgeons should pay
careful attention to complications during ST under local anesthesia and
in airway emergencies. Awake tracheostomy is 6.2 times more likely to
result in pneumothorax or pneumomediastinum than general
tracheostomy.\textsuperscript{5} Patients undergoing awake tracheostomy
often breathe spontaneously after tracheostomy and are prone to the
cough reflex due to the presence of a tracheal cannula, which may result
in subcutaneous emphysema. Particularly, in airway emergencies, the risk
of subcutaneous emphysema may have been increased because securing the
airway is a top priority, despite the consideration of safety. However,
no significant intergroup differences were observed in the risk of
postoperative infection. Considering that prophylactic administration of
antibiotics can prevent the incidence of PDT-induced wound
infection,\textsuperscript{17} the use of antibiotics for the treatment
of the primary disease may have reduced the incidence of infection after
ST. Other potential risk factors, such as DM or albumin level, did not
affect the complication rate in the present study. DM has been reported
to be a risk factor for surgical site infection (SSI) and for
postoperative infection,\textsuperscript{18} and compared to a normal
albumin level, a low albumin level (\textless{}3.5 g/dL) has been
associated with an approximately 2.5 times increased risk of SSI in
orthopedic surgery.\textsuperscript{19}Nevertheless, these factors may
not play an important role in minimally invasive surgeries like ST.

Several limitations of this study should be acknowledged. Retrospective
chart reviews are limited by incomplete or missing documentation.
Patients undergoing ST performed by surgeons at the other departments
were excluded from this analysis, and this might have resulted in the
underestimation of the overall incidence of postoperative complications.
Moreover, patients undergoing PDT, which involves placing a tracheostoma
by dilating the tracheal wall, were excluded from this study. When
bleeding occurs during and after PDT, it might be difficult to identify
the bleeding site, but in ST, the bleeding site can be easily identified
and hemostasis procedures can be performed immediately. Finally,
long-term postoperative complications were not investigated in this
study.

In the clinical setting, ST can be performed relatively safely
regardless of the use of CAT. However, the incidence of complications
can be high in cases of ST performed under local anesthesia or airway
emergencies. Thus, in such cases, ST should be performed carefully.

\textbf{5 CONCLUSION}

The current study suggests that CAT does not increase the risk of
postoperative complications after ST and that ST can be performed
relatively safely regardless of the use of antithrombotic drugs.
Nevertheless, when ST is performed under local anesthesia without
intubation and for emergency airway access, surgeons should practice
extra caution to prevent the occurrence of postoperative complications.



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18. Yuwen P, Chen W, Lv Het al. Albumin and surgical site infection risk
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19. Martin ET, Kaye KS, Knott Cet al. Diabetes and Risk of Surgical Site
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hospital epidemiology 2016; 37:88-99.

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