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\begin{document}

\title{Pericardial effusion caused by accidently placing a MicraTM
transcatheter pacing system into the coronary sinus}



\author[1]{Xueying Chen}%
\author[2]{Jing-Feng Wang}%
\author[3]{Yixiu Liang}%
\author[1]{YANGANG SU}%
\author[3]{JUN-BO GE}%
\affil[1]{Zhongshan Hospital Fudan University}%
\affil[2]{Zhongshan Hospital, Fudan University}%
\affil[3]{Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Shanghai Medical College of Fudan University}%


\vspace{-1em}



  
  \date{May 23, 2024}


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\selectlanguage{english}
\begin{abstract}
Leadless pacemaker emerged as a new pacing strategy to avoid pocket and
lead-related complications as compared with conventional pacemaker.
Whereas, cardiac perforation remains a major safety concern during the
implantation. Herein, we presented a rare case of cardiac perforation
with pericardial tamponade caused by accidently placing the delivery
catheter into the coronary sinus and she was successfully recovered
after immediate pericardiocentesis and discharged without other adverse
events.%
\end{abstract}%



\sloppy


\textbf{Introduction:}

Recently, leadless pacemaker emerged as a new pacing strategy to avoid
pocket and lead-related complications as compared with conventional
pacemaker\textsuperscript{1}. However, though the incidence of major
complications was demonstrated to be low to 1.51\% in Micra
transcatheter pacing system (TPS) (Medtronic, Minneapolis, MN,
USA)\textsuperscript{2}, cardiac perforation remains a major safety
concern with the incidence of about 0.13\%\textasciitilde{}1.3\% in
studies\textsuperscript{2,3}. Herein, we presented a case of cardiac
perforation with pericardial tamponade caused by accidently placing the
delivery catheter into the coronary sinus.

\textbf{Case presentation:}

A 83-year-old female (height, 148cm; weight, 41.5kg; body mass
index,18.9 kg[?]m\textsuperscript{-2}) suffered from sinus arrest of 5
seconds with paroxysmal atrial flutter and was admitted to our hospital
for leadless pacemaker implantation. The patient had percutaneous
coronary intervention with 2 stents implantation 1 month before
admission and dual anti-platelet therapy of aspirin (100mg/day) and
clopidogrel (75mg/day) continued to the procedure day. During the
procedure, the patient was received intravenous heparin 50u/kg before
Micra TPS was introduced into the right femoral vein. Then the delivery
catheter was directed across the tricuspid valve but was accidently
performed into the coronary sinus for several times. The device cup was
placed at the beginning of the posterior branch of coronary sinus as
confirmed by angiography (\textbf{Figure 1} ). Simultaneously,
pericardial effusion was detected at the left anterior oblique view
(\textbf{Figure 1B, 1C} ). But the patient was asymptomatic and remained
hemodynamically stable (blood pressure 134/76mmHg). After adjusting the
direction of the catheter, it was finally successfully performed into
the right ventricle and Micra leadless pacemaker was deployed at the
apex of right ventricle (\textbf{Figure 2} ) with good pacing parameters
(R wave amplitude, 9mV; threshold, 0.38V/0.24ms; impedance, 1000\selectlanguage{greek}Ω\selectlanguage{english}). At 2
hours post-procedure, the patient was found pericardial tamponade with
blood pressure dropped to 75/58 mmHg. Medium amount of pericardial
effusion mainly distribution around the posterior wall of left ventricle
was confirmed by echocardiogram (\textbf{Figure 3} ). The patient was
emergently received pericardiocentesis and drainage of 270 ml bloody
fluid. The symptoms were immediately relieved with blood pressure rise
to 130/80 mmHg. The pacing parameters remained stable. Dual
anti-platelet therapy was stopped for 5 days. No evidence of distinct
pericardial effusion was detected after the drainage tube removal.
Aspirin (100mg/day) and rivaroxaban (5mg/day) were prescribed
afterwards. The patient was discharged without pericardial effusion
reconfirmed by echocardiogram.

\textbf{Discussion:}

Due to the different fixation way, cardiac perforation remains one of
the severe complications of leadless pacemaker. It is recommended to
implant it at the septum of the right ventricle to minimize the
incidence of cardiac perforation \textsuperscript{2,4} though it is not
easy to achieve in all patients, especially in small hearts or cor
pendulum (drop hearts) cases. According to the
literatures\textsuperscript{2,3} {[}2,3{]}, the risk factors for cardiac
perforation in leadless pacemaker included female, low body mass index,
history of myocardial infarction and lung diseases. Therefore, each
patient should be carefully estimated before implantation, especially in
cases with these risk factors. Our patient was an old female with low
body mass index on dual anti-platelet therapy, which increased the
peri-procedure bleeding risk, although the study by Kiani
S\textsuperscript{5} et al showed continuation of therapeutic
anticoagulation during MICRA implantation was feasible and safe. It is
challenging to implant the leadless pacemaker in small-size heart cases
since the shape of the delivery catheter is fixed. In our patient, it is
not easy to perform Micra TPS across the tricuspid valve and accidently
place it into coronary sinus after multiple attempts. Left anterior
oblique view and angiography were useful to distinguish Micra TPS
locating at coronary sinus or right ventricle. Other than cardiac injury
by the fixation apparatus after deployment of Micra, cardiac perforation
resulting from the delivery catheter against the ventricular wall has
also been illustrated. Togashi I \textsuperscript{6}et al reported a
case of subclinical cardiac perforation caused by the edge of the device
cup penetrating into the ventricular wall prior to the deployment of the
leadless pacemaker. Another 91-year-old female case reported by Hai
JJ\textsuperscript{4} et al developed cardiac perforation due to
contrast injection against the RV anterior wall before verification of
sheath location. The cause of pericardial effusion in the present case
was probably the coronary vein injury by the edge of the device cup,
since pericardial effusion was detected by angiography when the catheter
was placed into coronary sinus (\textbf{Figure 1} ). The pericardial
effusion aggravated and pericardial tamponade occurred probably due to
dual anti-platelet therapy together with anti-coagulation of heparin. In
terms of short half-life period, bivalirudin might be more suitable than
heparin for peri-implantation anti-coagulation in patients on dual
anti-platelet therapy to reduce the bleeding risk.

\textbf{References}

1. El-Chami MF, Al-Samadi F, Clementy N, et al. Updated performance of
the Micra transcatheter pacemaker in the real-world setting: A
comparison to the investigational study and a transvenous historical
control. \emph{Heart Rhythm.} 2018;15(12):1800-1807.

2. Roberts PR, Clementy N, Al Samadi F, et al. A leadless pacemaker in
the real-world setting: The Micra Transcatheter Pacing System
Post-Approval Registry. \emph{Heart Rhythm.} 2017;14(9):1375-1379.

3. Reynolds DW, Ritter P. A Leadless Intracardiac Transcatheter Pacing
System. \emph{N Engl J Med.} 2016;374(26):2604-2605.

4. Hai JJ, Fang J, Tam CC, et al. Safety and feasibility of a midseptal
implantation technique of a leadless pacemaker. \emph{Heart
Rhythm.}2019;16(6):896-902.

5. Kiani S, Black GB, Rao B, et al. Outcomes of Micra leadless pacemaker
implantation with uninterrupted anticoagulation. \emph{J Cardiovasc
Electrophysiol.} 2019;30(8):1313-1318.

6. Togashi I, Sato T, Hoshida K, Soejima K. Subclinical cardiac
perforation caused by a Micra leadless pacemaker. \emph{J
Arrhythm.}2018;34(3):326-328.

\textbf{Figure legends:}

\textbf{Figure 1.} Angiography showing Micra TPS placing into the
coronary sinus: A. At poster-anterior view; Pericardial effusion (arrow)
at left anterior oblique view for the first attempt (B) and the second
attempt (C).

\textbf{Figure 2.} The images showing the location of Micra leadless
pacemaker: A. After deployment at right anterior oblique view; B. CT
scan after implantation indicating the leadless pacemaker locating at
the apex of right ventricular

\textbf{Figure 3.} The echocardiogram showing pericardial effusion (red
arrow) during diastolic phase mainly distribution around the posterior
wall of left ventricle.\selectlanguage{english}
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