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\begin{document}

\title{Efficacy and safety of axillary vein puncture real-time guided by
roadmap fluoroscopy in cardiac pacemaker implantation}



\author[1]{Qiying Chen}%
\author[1]{Bangwei Wu}%
\author[1]{Zhidong Zhu}%
\author[1]{Haiming Shi}%
\author[1]{Junping Li}%
\author[1]{Bo Jin}%
\affil[1]{Huashan Hospital Fudan University}%


\vspace{-1em}



  
  \date{May 23, 2024}


\begingroup
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\selectlanguage{english}
\begin{abstract}
\textbf{Objective}: Roadmap fluoroscopy has never previously been
evaluated for axillary vein puncture in clinical practice. Our
retrospective cohort study was performed to investigate the efficacy and
safety of axillary vein puncture real-time guided by roadmap fluoroscopy
in cardiac pacemaker implantation. \textbf{Methods and Results}: A total
of 178 patients undergoing axillary vein puncture in permanent pacemaker
implantation were included in the present cohort study during a 1-year
period at our institution. All procedures were performed by the
operators with previous experience in axillary approach. Primary
endpoint was defined as axillary vein success rate. Secondary endpoints
were venous access site change, time to obtain venous access, procedural
time, and complication rate. For the primary outcomes, a higher success
rate was observed in the roadmap group compared with the blind puncture
group (95.2\% vs 78.7\%; \emph{P}\textless{}0.001), as well as a lower
rate of venous access site change (7.1\% vs 35.1\%; \emph{P}
\textless{}0.001) and shorter time to obtain venous access and
procedural time, with lower complications (3.6 \% vs 6.4 \%;
\emph{P}\textless{}0.01). \textbf{Conclusion:} The roadmap fluoroscopy
real-time guided axillary venous access is safer and has a better
success rate and faster execution time compared with the blind axillary
puncture in cardiac pacemaker implantation. However, further larger
scale prospective randomized controlled trials are required to confirm
the findings.%
\end{abstract}%



\sloppy


\textbf{Introduction}

Cardiac pacemaker implantation is the mainstay therapy for the patients
with bradyarrhythmia as well as those at risk of sudden cardiac death
and chronic heart failure. \textsuperscript{{[}1-3{]}}Obtaining
transvenous access may be achieved by various methods including a
cephalic vein cutdown,\textsuperscript{{[}4{]}} or using the modified
Seldinger technique to access the axillary or subclavian vein. The
venous access for endocardial lead placement of cardiac pacemaker is
often achieved by blind puncture of the subclavian or axillary vein
using anatomical landmarks. \textsuperscript{{[}5, 6{]}} However, severe
complications can occur in clinical practice, such as pneumothorax,
hemothorax, arterial puncture, and brachial plexus injury.
\textsuperscript{{[}7, 8{]}}

To overcome the inherent limitations, we apply new roadmap fluoroscopy
approach to guide the axillary vein puncture. Roadmap real-time guided
puncture may overcome this issue, enabling an effective puncture to
enhance visualization with a safer procedure. We report the
retrospective cohort study during a 1-year period at our institution. To
our knowledge, roadmap fluoroscopy has never previously been evaluated
for use in cardiac pacemaker implantation. \textsuperscript{{[}9-11{]}}

\textbf{Methods}

\textbf{Subjects and data collection}

In our preliminary study, the Judkins catheter was pulled back to the
proximal portion of the axillary artery and contrast agent was
simultaneously and manually injected through both the axillary artery
and the ipsilateral peripheral vein after the transradial coronary
angiography in 20 patients with coronary artery disease. The
radiological views of the axillary artery and vein as well as other
anatomical structures were recorded to elevate the anatomical
relationship at 35\selectlanguage{ngerman}º caudal orientation routinely.

The present retrospective study was carried out in Huashan Hospital,
Fudan University. A total of 178 patients undergoing axillary vein
puncture in cardiac pacemaker implantation were included in our cohort
study from July 2020 to June 2021. Eligible patients were all those with
an indication of permanent pacemaker implantation including
single-chamber and dual-chamber pacemaker. The cardiac pacemaker
implantation was approved by the ethics review board of Huashan
Hospital, and written informed consent was obtained from all patients in
our observational study.

The efficacy and safety of the roadmap real-time guidied puncture
strategy was assessed in the consecutive 84 patients and was compared
with the standard blind puncture approach in 94 patients preceding
pacemaker implantation. Implantation of all cardiac pacemakers was
performed in the catheter laboratory by the electrophysiologists with
more than 5 years of experience. Anticoagulated patients with low
thromboembolic risk were operated after suspension of anticoagulant
treatment to minimize bleeding risk. All axillary vein punctures were
performed via a right-sided approach under local anesthesia. Antibiotic
prophylaxis was administered immediately before the procedure routinely.

\textbf{Description of vein access techniques}

We describe our preferred method of obtaining axillary venous access
which is roadmap real-time guidied strategy to allow visualization for
improved efficacy and safety. After local anesthesia of the skin and
subcutaneous tissue, an incision is made parallel to the groove and a
pocket is made medially at the level of the fascial plane. The axillary
vein is the continuation of the brachial vein, originating at the lower
margin of the teres major muscle and terminating at the lateral margin
of the first rib. Roadmap technology characteristics that make the
axillary vein puncture easily to enhance visualization with a safer
procedure (Figure 1). Roadmap of right axillary vein was used to
determine the optimum puncture site and access direction. In the control
group, blind axillary vein puncture was performed at the operator's
direction.

As shown in Figure 2, the target region is outlined with a black box at
35º caudal orientation. To obtain the roadmap real-time guided axillary
vein access, ipsilateral contrast venography was performed. The puncture
needle enters axillary vein and the J\selectlanguage{english}-shaped guidewire has been placed
through the axillary vein and advanced down the subclavian vein to
inferior vena cava successfully. Our technique of axillary venous access
is rapid, requires intravenous contrast, is reproducible and carries
minimal risk. Access from a more parallel angle to the vessel may prove
beneficial to increase the chance of axillary vein access. The 35o
caudal view allows for optimal visualization of the lung border and
first rib and therefore should reduce the chance for pneumothorax and
hemothorax.

\selectlanguage{english}\textbf{Follow-up protocol}

After the cardiac pacemaker implantation and at 24 hours a chest X\selectlanguage{english}-ray
was made to check lead position, detect pneumothorax, hemothorax, and
other complications. Before discharge, all patients and permanent
pacemakers were checked to confirm the relevant complications. This
evaluation was repeated in the first, third, sixth and twelfth months
after the discharge.

\textbf{Outcome} \textbf{measures}

The primary outcomes were the pacemaker implantation efficacy and safety
in our study. The implantation efficacy was defined as the success of
implant all the pacing leads indicated through the assigned venous
access. The implantation safety was defined as the development of
complications in or after cardiac pacemaker implantation. Complications
were defined as development of pneumothorax, hemothorax, pericardial
effusion, cardiac tamponade, venous thrombosis, lead dislodgement,
device infection, and lead fracture. Bleeding considered when this
required transfusion or pocket surgical revision. Thrombosis was
considered when an echo\selectlanguage{english}-doppler confirmed it and when the anticoagulant
therapy resolved a clinical diagnosis. Primary endpoint was defined as
axillary vein success rate. Secondary endpoints were venous access site
change, time to obtain venous access, procedural time, and complication
rate.

\textbf{Statistical analysis}

Primary and secondary endpoints were analyzed following the
intention-to-treat principle. Continuous variables with normal
distribution were presented as mean value and standard deviation.
Differences in categorical variables were assessed with Fisher's exact
two-tailed test. Data analysis were performed with SPSS 12.0 and
statistical significance was defined at an alpha level of 0.05.

\textbf{Results}

Between July 2020 and June 2021, a total of 178 patients undergoing
axillary vein puncture in cardiac pacemaker implantation were enrolled,
of whom 84 were assigned to the roadmap group and 94 to the blind
puncture group. There were no significant differences in cardiovascular
risk factors in the two groups. The mean ages in the road map group and
the blind puncture group were 62.4 years and 64.6 years in the
observational study, respectively (Table 1).

Procedure data and associated implantation complications are shown in
Table 2. The success rate of venous access was superior in the roadmap
group than in the blind puncture group (95.2\% vs 78.7\%,
\emph{P}\textless{}0 .001), as well as a lower rate of venous access
site change (7.1\% vs 35.1\%; \emph{P} \textless{}0.001). Time to access
axillary vein was significantly shorter in the roadmap group (6.2 +- 2.2
min vs 11.4 +- 4.5 min, \emph{P} \textless{}0 .001). Meanwhile,
implantation duration was significantly shorter in the road map group
(36.2 +- 8.2 min vs 43.4 +- 9.8 min, \emph{P} \textless{} 0.01).
Fluoroscopy duration was comparable in both study groups (5.2 +- 2.1 min
vs 6.4 +- 2.8 min,\emph{P} = 0.28).

In the blind puncture group, there were more implantation complications
(n = 6; 6.4\%) than in the roadmap group (n = 3; 3.6\%), the differences
achieved statistical significance (\emph{P} \textless{} 0.01). During 12
month follow\selectlanguage{english}-up, there was pocket infection in one patient in the blind
puncture group, lead dislodgement in one patient in the roadmap group.
One patient developed venous thrombosis during follow\selectlanguage{english}-up in each group.

\textbf{Discussion}

Features of the roadmap real-time guided approach to the axillary vein
access that may result in widespread acceptance are its simplicity and
ease. Furthermore, specialized imaging tools are not required nor is a
detailed understanding of precise anatomic relationships within this
region. \textsuperscript{{[}12, 13{]}} There is also an intuitive
benefit of documenting patency of the venous system and presence of
venous anomalies. The presence of contrast within the axillary vein
provides a clear target to guide needle puncture thus avoiding the
inherent reluctance of many physicians to perform a blind stick. An
additional advantage of this approach is that needle entry can be
performed anywhere along the course of the axillary vein. The primary
highlight being the use of roadmap to guide venous entry rather than
walking the needle laterally along the first rib until venous entry is
achieved. \textsuperscript{{[}14, 15{]}} Furthermore, the approach has
the potential to eliminate the risk of pneumothorax and hemothorax.

The results of our retrospective cohort study demonstrate significant
superiority of the roadmap real-time guided axillary vein approach for
cardiac lead implantation. The rationale for this study was based on
previous literature data demonstrating high success rate of axillary
vein puncture as the route for pacemaker lead insertion, mostly from
observational studies. \textsuperscript{{[}16-18{]}} The higher axillary
success rate guided by road map fluoroscopy was confirmed in our present
observational study. Roadmap imaging also allows the possibility of
evaluating vein patency before pocket incision, which is especially
useful in special patients who previously had undergone thoracic surgery
or radiotherapy.

With regard to complication rate, the roadmap real-time guided axillary
approach proved to be safer compared with blind axillary vein puncture.
Compared to data previously reported in the literature, the incidence of
axillary puncture complications in our study was similar to that
previously reported. \textsuperscript{{[}19-21{]}} The complications
occurred in some elderly, malnourished patients. The lower incidence of
complications can be explained by our preferred method of obtaining
axillary venous access which is roadmap guiding strategy to allow
real-time visualization.

Our shorter time to axillary venous access in the roadmap application
reinforces the findings of previous study which demonstrated in
nonrandomized fashion a shorter time to position the leads in the
superior vena cava using the ultrasound -guided axillary
approach.\textsuperscript{{[}22, 23{]}} From a clinical point of view,
longer procedure duration has been associated with increased infection
risk, indicating that shorter duration interventions and lower incidence
of complications, in addition to enabling quicker operating room
turnover, may lead to better infective outcomes.

For the first time we reported roadmap fluoroscopy using for the
axillary vein visualized as it approaches the first rib and allows one
to clearly see the anterior outline of the lungs at 35o caudal
orientation. The puncture needle enters axillary vein guided by roadmap
fluoroscopy and guidewire has been placed through the axillary vein and
advanced down the subclavian vein to inferior vena cava successfully. By
reviewing the literature, we find this to be a novel technique, by means
of which we succeed in overcoming the above-mentioned long-standing
problem. \textsuperscript{{[}24-26{]}} As a newly introduced solution
for old challenge, we suggest using roadmap fluoroscopy guided puncture
for cardiac pacemaker implantation in clinical practice.

The main limitation of our retrospective cohort study is the lack of a
randomized design that makes our findings hypothesis generating only,
some caution is needed in the interpretation of the results. In
addition, the short follow-up period of this study was not sufficient to
allow evaluation of long-term lead-related complications. Moreover,
well-designed study with larger sample size and longer follow-up should
be conducted to confirm the final results.

In conclusion, roadmap fluoroscopy presented above may prove to be safer
and better success in axillary vein puncture for cardiac pacemaker
implantation. Our outcomes indicate that roadmap real-time guided
puncture was superior to blind puncture in terms of success rate, time
to venous access, and procedural time, with lower complication rate. The
results of the study would have to encourage electrophysiologists to
learn the roadmap guided axillary vein access technique. However,
further larger scale randomized controlled trials are required to verify
the present findings.

\textbf{Acknowledgements}

We gratefully acknowledge Dr. Qiang Xu for his radiological suggestions.

\textbf{Data access statement}

All the data supporting our findings is contained within the manuscript.

\textbf{Ethics approval and consent to participate}

We identified the patient during routine clinical practice and consented
to the interventions after elaborate information. The cardiac pacemaker
implantation was approved by the ethics review board of Huashan
Hospital, and written informed consent was obtained from all patients in
our observational study.

\textbf{References}

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341-343.

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\textbf{Table 1} Demographic characteristics of patients in pacemaker
implantation\selectlanguage{english}
\begin{longtable}[]{@{}lll@{}}
\toprule
& Roadmap group (n=84) & Blind puncture group (n=94)\tabularnewline
\midrule
\endhead
Age (y) & 62.4\selectlanguage{ngerman}±7.2 & 64.6\selectlanguage{ngerman}±7.6\tabularnewline
Sex (f/m) & 40/44 & 45/49\tabularnewline
Hypertention (+/-) & 46/38 & 52/42\tabularnewline
Diabetes mellitus (+/-) & 22/62 & 24/70\tabularnewline
Coronary artery disease (+/-) & 32/52 & 36/58\tabularnewline
Heart failure (+/-) & 12/72 & 14/80\tabularnewline
Stroke (+/-) & 9/75 & 12/82\tabularnewline
CKD (+/-) & 20/64 & 24/70\tabularnewline
COPD (+/-) & 14/70 & 17/77\tabularnewline
Obesity (+/-) & 22/62 & 26/68\tabularnewline
Smoking (+/-) & 20/64 & 25/69\tabularnewline
Hypercholesterolemia (+/-) & 24/60 & 28/66\tabularnewline
NT-ProBNP (pg/ml) & 676\selectlanguage{ngerman}±42 & 648\selectlanguage{ngerman}±38\tabularnewline
eGFR (ml/min/1.73m\textsuperscript{2}) & 81.21\selectlanguage{ngerman}±7.44 &
82.08\selectlanguage{ngerman}±8.52\tabularnewline
LVEF (\%) & 52.86\selectlanguage{ngerman}±3.92 & 53.50\selectlanguage{ngerman}±4.12\tabularnewline
Pacemaker indication & &\tabularnewline
Atrioventricular block & 54 & 58\tabularnewline
Sinus node disease & 30 & 36\tabularnewline
Type of paccemaker & &\tabularnewline
Single-chamber & 28 & 32\tabularnewline
Dual-chamber & 56 & 62\tabularnewline
\bottomrule
\end{longtable}

COPD, chronic obstructive pulmonary disease; CKD, chronic kidney
disease; eGFR, estimated glomerular filtration rate; LVEF,
left~ventricular ejection fraction; NT-ProBNP, amino-terminal pro-brain
natriuretic peptide

\textbf{Table 2} Outcomes and complications of patients in pacemaker
implantation\selectlanguage{english}
\begin{longtable}[]{@{}lll@{}}
\toprule
& Roadmap group (n=84) & Blind puncture group (n=94)\tabularnewline
\midrule
\endhead
Axillary vein success rate (\%) & 95.2 & 78.7\tabularnewline
Venous access site change (\%) & 7.1 & 35.1\tabularnewline
Time to venous access (min) & 6.2\selectlanguage{ngerman}±2.2 & 11.4\selectlanguage{ngerman}±4.5\tabularnewline
Procedural time (min) & 36.2\selectlanguage{ngerman}±8.2 & 43.4\selectlanguage{ngerman}±9.8\tabularnewline
Fluoroscopy time (min) & 5.2\selectlanguage{ngerman}±2.1 & 6.4\selectlanguage{ngerman}±2.8\tabularnewline
Complication rate (\%) & 3.6 & 6.4\tabularnewline
Pocket hamotoma & 1 & 1\tabularnewline
Pneumothorax & 0 & 2\tabularnewline
Hemothorax & 0 & 1\tabularnewline
Venous thrombosis & 1 & 1\tabularnewline
Lead dislodgement & 1 & 0\tabularnewline
Cardiac tamponade & 0 & 0\tabularnewline
Device infection & 0 & 1\tabularnewline
Lead fracture & 0 & 0\tabularnewline
\bottomrule
\end{longtable}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image1/image1}

\end{center}
\end{figure}

\textbf{Figure 1} Fluoroscopy showing the anatomical relationship
between the axillary artery and axillary vein visualized at 35\selectlanguage{ngerman}º caudal
orientation. (A) Angiography shows the anatomy of axillary vein and
axillary artery. (B) Roadmap fluoroscopy shows the anatomy of axillary
vein and axillary artery.\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image2/image2}

\end{center}
\end{figure}

\textbf{Figure 2} Axillary vein puncture guided by roadmap fluoroscopy
in pacemaker implantation. The target region is outlined with a black
box at 35\selectlanguage{ngerman}º caudal orientation. (A) The grey line demonstrates the
location of puncture needle to entry axillary vein guided by roadmap
fluoroscopy. (B) The J\selectlanguage{english}-shaped guidewire has been placed through the
axillary vein and advanced down the subclavian vein to inferior vena
cava successfully.

\selectlanguage{english}
\FloatBarrier
\end{document}

