\documentclass[10pt]{article}

\usepackage{fullpage}
\usepackage{setspace}
\usepackage{parskip}
\usepackage{titlesec}
\usepackage[section]{placeins}
\usepackage{xcolor}
\usepackage{breakcites}
\usepackage{lineno}
\usepackage{hyphenat}





\PassOptionsToPackage{hyphens}{url}
\usepackage[colorlinks = true,
            linkcolor = blue,
            urlcolor  = blue,
            citecolor = blue,
            anchorcolor = blue]{hyperref}
\usepackage{etoolbox}
\makeatletter
\patchcmd\@combinedblfloats{\box\@outputbox}{\unvbox\@outputbox}{}{%
  \errmessage{\noexpand\@combinedblfloats could not be patched}%
}%
\makeatother


\usepackage{natbib}




\renewenvironment{abstract}
  {{\bfseries\noindent{\abstractname}\par\nobreak}\footnotesize}
  {\bigskip}

\titlespacing{\section}{0pt}{*3}{*1}
\titlespacing{\subsection}{0pt}{*2}{*0.5}
\titlespacing{\subsubsection}{0pt}{*1.5}{0pt}


\usepackage{authblk}


\usepackage{graphicx}
\usepackage[space]{grffile}
\usepackage{latexsym}
\usepackage{textcomp}
\usepackage{longtable}
\usepackage{tabulary}
\usepackage{booktabs,array,multirow}
\usepackage{amsfonts,amsmath,amssymb}
\providecommand\citet{\cite}
\providecommand\citep{\cite}
\providecommand\citealt{\cite}
% You can conditionalize code for latexml or normal latex using this.
\newif\iflatexml\latexmlfalse
\providecommand{\tightlist}{\setlength{\itemsep}{0pt}\setlength{\parskip}{0pt}}%

\AtBeginDocument{\DeclareGraphicsExtensions{.pdf,.PDF,.eps,.EPS,.png,.PNG,.tif,.TIF,.jpg,.JPG,.jpeg,.JPEG}}

\usepackage[utf8]{inputenc}
\usepackage[ngerman,english]{babel}



\usepackage{float}








\begin{document}

\title{Repositioning and Extraction of Stylet-Driven Pacing Leads with
Extendable Helix used for Left Bundle Branch Area Pacing.}



\author[1]{Jean-Benoit le Polain de Waroux}%
\author[1]{Jean-Yves Wielandts}%
\author[1]{Kris Gillis}%
\author[1]{Gabriela Hilfiker}%
\author[2]{Antonio Sorgente}%
\author[2]{Lucio Capulzini}%
\author[1]{Bert Geerts}%
\author[1]{Sebastien Knecht}%
\author[1]{Mattias Duytschaever}%
\author[1]{Rene Tavernier}%
\affil[1]{AZ Sint-Jan Brugge-Oostende AV}%
\affil[2]{Hospital Centre EpiCURA Hornu}%


\vspace{-1em}



  
  \date{June 16, 2024}


\begingroup
\let\center\flushleft
\let\endcenter\endflushleft
\maketitle
\endgroup





\selectlanguage{english}
\begin{abstract}
Abstract: Conventional stylet-driven leads with extendable helix can be
implanted successfully for Left Bundle Branch Area Pacing (LBBAP) with a
low acute complication rate. However, removal and repositioning
techniques of these leads haven't been yet described. We report 2 cases
in which lead repositioning after a first unsuccessful attempt to LBBAP
was associated with fracture of the helix rotating mechanism and failure
to fully extract the pacing lead.%
\end{abstract}%



\sloppy


\textbf{Repositioning and Extraction of Stylet-Driven Pacing Leads with
Extendable Helix used for Left Bundle Branch Area Pacing.}

Jean-Benoi\selectlanguage{english}t le Polain de Waroux MD, PhD*; Jean-Yves Wielandts, MD, MSc,
PhD*; Kris Gillis, MD, PhD*; Gabriela Hilfiker MD*; Antonio Sorgente,
MD, PhD\selectlanguage{ngerman}§; Lucio Capulzini, MD§; Bert Geerts, MD°; Se\selectlanguage{english}bastien Knecht, MD,
PhD*; Mattias Duytschaever, MD, PhD*\#; Rene \selectlanguage{english}Tavernier, MD, PhD*

\textbf{Affiliations:}* Department of Cardiology, Sint-Jan Hospital,
Bruges, Belgium

\selectlanguage{ngerman}° Department of Radiology, Sint-Jan Hospital, Bruges, Belgium

\# Department of Internal Medicine, Ghent University, Belgium

§ Department of Cardiology, Epicura Centre Hospitalier, Hornu, Belgium

\textbf{Corresponding author:}

Prof. le Polain de Waroux Jean-Benoi\selectlanguage{english}t

Department of Cardiology, Sint-Jan Hospital, 8000 Bruges, Belgium

E-mail: jean-benoit.lepolaindewaroux@azsintjan.be

Tel: +32 50 45 2670; Fax: +32 50 45 2679

\textbf{Short title:} Extraction and repositioning of stylet-driven
pacing leads for left bundle area stimulation

\textbf{Keywords:} His bundle pacing, Left bundle area pacing,
Physiologic pacing, Complication.

\textbf{Disclosures:} Pr. Jean-Benoit le Polain de Waroux reports non
significant speaker fees and honoraria for proctoring and teaching
activities from Medtronic, Boston Scientific, Abbott and Biotronik.

\textbf{Funding:} None

\textbf{Abstract}

Conventional stylet-driven leads with extendable helix can be implanted
successfully for Left Bundle Branch Area Pacing (LBBAP) with a low acute
complication rate. We report 2 cases in which lead repositioning after a
first unsuccessful attempt to LBBAP was associated with fracture of the
helix rotating mechanism and failure to fully extract the pacing lead.

\textbf{Case description} Two patients referred for LBBAP were implanted
with a conventional stylet-driven (SD) lead with an extendable helix
(Biotronik Solia S60, SE \& Co, Berlin, Germany) delivered through a
dedicated preshaped sheath (Selectra 3D, Biotronik, limited market
release). Before implantation, the lead was prepared by exposing the
helix. Using the stylet insertion tool, an additional 10 clockwise (CW)
rotations was applied. This pretensioning of the inner coil was
maintained by further pushing the stylet insertion tool onto the
proximal silicon sealing ring of the lead. This maneuver is essential to
maintain the pre-applied torque on the screw extension mechanism and
avoid unwinding of the extendable helix during transseptal screwing of
the lead.\textsuperscript{1,2} LBBAP was subsequently attempted
following the technique previously described by Huang et
al.\textsuperscript{3} In both cases, recording of His potential,
mapping of the right ventricular (RV) septal implant site, and screwing
the lead transseptally towards the left side of the interventricular
septum using outer lead body rotations was easy. In patient one, a
narrow paced QRS of 102 ms was obtained but no LBBB capture was clearly
demonstrated and pacing thresholds remained high (2.0 V with a pulse
duration of 1 ms). Therefore, an attempt to reposition the lead was
undertaken. With the stylet fully inserted to the tip of the pacing
lead, counterclockwise (CCW) rotations of the connector pin were first
applied to release tension on the inner coil and retract the exposed
helix. However, the helix failed to retract. An attempt to unscrew the
helix by CCW rotation of the entire lead also remained unsuccessful. The
implanter decided to test lead anchoring by gently pulling on the lead.
This maneuver immediately resulted in the misalignment of the helix.
With further efforts to extract the lead using lead rotations, traction
and counter-traction with the sheath, the helix elongated and finally
abruptly snapped (See Figure 1A). This patient was finally implanted
with a biventricular pacemaker without further complications. Computed
tomography confirmed the deep insertion of the residual helix fragment
into the interventricular septum (See Figure 1B).

LBBAP in patient two was attempted using a similar implantation
technique. As in patient one, no QRS changes indicative of LBBAP were
obtained, and pacing threshold was high (\textgreater{}2.5 V with a
pulse duration of 1 ms). Lead repositioning was attempted by CCW turning
of the outer lead body without fixation of the connector pin. This
maneuver resulted in rupture of the fixation mechanism and the
distortion of the helix (See Figure 2). Further attempts to extract the
lead by CCW turning of the connector pin or outer lead body were
ineffective. The lead was abandoned in the septum and a second lead was
implanted in the right ventricular apex.

\textbf{Discussion}

Recent growing interest for tissue conduction pacing has incited
pacemaker companies to develop their own dedicated implantation tools
and solutions. The Select Secure 3830 lead (Medtronic Inc., Minneapolis,
MN, USA) is characterized by a unique narrow caliber Lumen-Less (LL)
isodiametric design with an exposed helix and is implanted using a
dedicated preshaped sheath (C315HIS, Medtronic Inc.). Recently, Zanon et
al. described the feasibility of LBBAP using conventional SD leads with
an extendable helix, also delivered through a dedicated preshaped sheath
(Selectra 3D, Biotronik, limited market release). De Pooter et al.
demonstrated comparably high implant success rates in LBBAP with both
types of leads. Both publications describe the preparation and
implantation technique of SD leads for LBBAP but no specific
recommendations are provided on how to troubleshoot difficult
implantations, with reference in particular to their removal and
repositioning.

\textbf{Extendable / retractable helix pacing lead for LBBAP:}

Compared to LL leads, SD pacing leads benefit from better support,
stability and steerability during transseptal screwing for LBBAP and
allow for a more customized implant approach in the setting of anatomic
variations. However, careful pre-tensioning of the inner coil and
locking of the connector pin is required before use (See Figure 3A and
3B). As transseptal screwing is associated with more distal grip and
recoil of the outer lead body and helix, inadequate preparation of the
lead may result in unwanted retraction of the helix during CW outer lead
body rotations. For the same reason, full helix retraction is critical
before attempting lead removal by CCW turning of the outer lead body. As
illustrated by our second case, insufficient locking of the connector
pin to the outer lead body during this maneuver may further extend the
helix and eventually fracture the helix rotating mechanism. (Fig 3C) As
illustrated by our first case, any premature traction on the lead with
the helix incompletely retracted may result in helix misalignment or
deformation. Although both implanters were experienced with tissue
conduction pacing, they were relatively na\selectlanguage{ngerman}ïve to the use of an SD lead
for LBBAP. In his recent paper, De Pooter et al. reported an average of
2 attempts per patient to reach the left side of the ventricular septum.
No issues during lead repositioning were reported. With experience, the
following suggestions can be made before unscrewing SD leads in LBBAP:
1) Verify full insertion of the stylet to the tip of the lead and obtain
maximum support before retraction by maintaining the delivery sheath
firmly against the RV septum 2) Much more than the minimum number of
connector pin rotations to expose the helix are usually necessary to
fully retract the helix 3) If the helix can not be retracted, avoid CCW
rotation of the outer lead body without validated fixation of the
connector pin by means of the stylet insertion tool (Fig 2D). 4) After
removal and before repositioning, carefully inspect the screwing
mechanism.

\textbf{Ideal lead for LBBAP:}

Although SD leads with extendable helix may offer some advantages in
terms of steerability and septum penetration, the fragility of the
screwing mechanism requires great precaution during repositioning and
raises concerns regarding long-term extractability. In our opinion,
ideal leads for LBBAP should combine a robust SD isodiametric narrow
caliber design with an exposed active helix fixation.

\textbf{Conclusion:}

The present paper highlights the potential difficulties encountered
during acute repositioning of stylet driven leads used for LBBAP and
questions their long-term extractability.

\textbf{Bibliography:}

\begin{enumerate}
\tightlist
\item
  De Pooter J, Calle S, Timmermans F,Van Heuverswyn F. Left bundle
  branch area pacing usingstylet\selectlanguage{english}-driven pacing leads with a new delivery
  sheath:A comparison with lumen\selectlanguage{english}-less leads. J CardiovascElectrophysiol.
  2020;1--10.
\item
  Zanon F, Marcantoni L, Pastore G, Baracca E. Left bundle branch pacing
  by standard stylet-driven lead: preliminary experience of two case
  reports. Heart Rhythm Case Reports 2020;6:614--617
\item
  Huang W, Chen X, Su L, Wu S, Xia X, Vijayaraman P. A beginner's guide
  to permanent left bundle branch pacing. Heart Rhythm Dec
  2019;16:1791-1796.
\end{enumerate}

\textbf{Figure 1.}

Patient 1: (\textbf{A} ) Antero-posterior fluoroscopic projection
showing the fractured helix (white arrow) with residual fragments in the
interventricular septum (black frame). \textbf{B} . Computed tomography
segmentation showing the broken helix deeply inserted into the
inter-ventricular septum (white arrow).\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image1/image1}

\end{center}
\end{figure}

\textbf{Figure 2.}

Patient 2: Right Anterior Oblique fluoroscopic projection (30\selectlanguage{ngerman}°) showing
the distortion of the helix.\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image2/image2}

\end{center}
\end{figure}

\textbf{Figure 3.}

\textbf{3(A)} Technical representation and legend of a stylet-driven
lead.

\textbf{3(B)} Steps to prepare the helix for LBBAP: After exposition of
the screw, pre-tensioning of the inner coil is provided by clockwise
rotations (CWR) of the stylet insertion tool. The torque on the inner
coil is later maintained by plugging the stylet insertion tool onto the
first silicon sealing of the electrode.

\textbf{3(C)} Manual counter-clockwise rotations (CCWR) of the outer
lead body without appropriate fixation of the connector pin.
Illustration of the paradoxical effect of further helix extension or
inner coil over-tensioning (with eventual rupture of the rotating
mechanism).

\textbf{3(D)} With adequate fixation of the connector pin, CCW torque
applied to the outer lead body is progressively transmitted to the screw
and allows for lead removal.\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image3/image3}

\end{center}
\end{figure}

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

