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\begin{document}

\title{Current practice in Transvenous Lead Extraction in Latin-American:
Latin-American Heart Rhythm Association Survey}



\author[1]{Juan Carlos  Diaz}%
\author[2]{Jorge Romero}%
\author[3]{Roberto Costa}%
\author[4]{Alejandro Cuesta}%
\author[5]{Luigi  DiBiase}%
\author[2]{Isabella Alviz}%
\author[5]{Alejandro Velasco}%
\author[5]{Mohamed Gabr}%
\author[6]{Mauricio  Duque}%
\author[1]{Jorge Marin}%
\author[7]{Julian Aristizabal}%
\author[8]{Jorge Velásquez}%
\author[8]{Cesar Niño}%
\author[9]{Hector Mazzetti}%
\affil[1]{Clinica Las Americas}%
\affil[2]{Montefiore Medical Center}%
\affil[3]{Universidade de São Paulo Instituto do Coração}%
\affil[4]{Centro Cardiovascular Universitario}%
\affil[5]{Montefiore Hospital and Medical Center}%
\affil[6]{Universidad CES}%
\affil[7]{Clinica Las Vegas}%
\affil[8]{Clinica Somer}%
\affil[9]{Sanatorio de la Trinidad de San Isidro}%


\vspace{-1em}



  
  \date{May 05, 2024}


\begingroup
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\selectlanguage{english}
\begin{abstract}
Background: Transvenous lead extraction (TLE) is standard of care for
the management of patients with cardiac implantable electronic device
infection or lead related complications. Currently, objective data on
TLE in Latin America is lacking. Objective: To describe the current
practice standards in Latin American centers performing TLE. Methods: An
online survey was sent through the mailing list of the Latin American
Heart Rhythm Association (LAHRS). Online reminders were sent through the
mailing list; duplicate answers were discarded. The survey was available
for one month, after which no more answers were accepted. Results: A
total of 48 answers were received, from 44 different institutions
(39.6\% from Colombia, 27,1\% from Brazil), with most respondents (83\%)
being electrophysiologists. Twenty-nine institutions (66\%) performed
less than 10 lead extractions/year, with 7 (15\%) institutions not
performing lead extraction. Although most institutions in which lead
extraction is performed reported using several tools, mechanical
rotating sheaths were cited as the main tool (73\%), 13.5\% reported the
use of mechanical extraction sheaths and only 13.5\% reporting the use
of laser sheaths. Management of infected leads was performed according
to current guidelines. Conclusion: This survey is the first attempt to
provide information on TLE procedures in Latin America and could provide
useful information for future prospective registries. According to our
results, the number of centers performing high volume lead extraction in
Latin America is smaller than that reported in other continents, with
most interventions performed using mechanical tools. Future prospective
registries assessing acute and long-term success are needed.%
\end{abstract}%



\sloppy


\textbf{Introduction}

Over the last decades, the number of cardiac implantable electronic
devices (CIED) implanted has steadily increased as technological
advances have allowed for a greater number of conditions to be treated
with CIEDs (1,2). Long-term CIED implants are usually associated with a
need to add or replace existing electrodes due to lead failure or need
for device upgrade, with many patients having abandoned leads which
increase the risk of infection and venous thrombosis. Moreover, implants
are being performed in older patients with more comorbidities (3,4).
This increase in implants and the use of devices in older, sicker
patients have led to a higher number of device related infection and
lead related complications (5,6). As such, there is an increasing need
for lead extraction procedures (7,8). Although technological advances
have allowed for safer and easier percutaneous lead extraction
procedures, access to different tools and the high costs limit in many
cases their widespread availability and as such their use varies in
different institutions and countries.

Although several centers in Latin America perform lead extraction,
objective data on current practice is lacking. In order to obtain
information on the current lead extraction practice in Latin America, we
performed this survey.

\textbf{Methods}

In this descriptive cross-sectional observational study, physicians
working at electrophysiology services in Latin American countries were
sent a 16-question online survey (table 1) created using a commercial
online platform (Google Forms\selectlanguage{ngerman}®) were contacted using the Latin American
Heart Rhythm Society (LAHRS) directory. Additional invitations were sent
through national cardiology medical associations. Information regarding
city and country of origin, hospital center, participation in lead
extraction procedures, operator experience, number of procedures per
year, available tools and procedural characteristics was collected. If a
respondent answered that extractions were not performed in his/her
institution, no further questions regarding lead extraction procedures
were made. The online survey was available from October 1 to October
31\textsuperscript{st}, 2020. All duplicate answers were eliminated.
Results are presented as absolute frequencies and percentages for
categorical variables.

\textbf{Results}

The survey was answered by 48 participants from 44 different
institutions spanning 8 different countries. Transvenous lead extraction
(TLE) was performed in 85\% of these institutions. Most respondents were
from Colombia (39.6\%) and Brazil (27.1\%) (figure 1A); 82\% of
respondents were electrophysiologists (figure 1B) with 71\% of
respondents having more than 10 years of experience (figure 1C).

Procedural characteristics

Forty-one respondents (85\%) performed lead extractions, with most
institutions (66\%) performing less than 10 procedures per year and only
11\% of of them preforming \textgreater{}25 procedures per year (figure
2A). Procedures were generally performed under general anesthesia
(97\%). As expected, based on the respondent's specialty,
electrophysiologists were reported to be in charge of lead extractions
in 85\% of cases (figure 2B). Out of the 38 institutions in which lead
extraction was performed, laser powered sheaths were available in only 5
institutions (13\%), while mechanical tools (either mechanical dilators
or rotating sheaths) were used by most respondents (figure 2C).
Regarding safety measures and intra-procedural monitoring (figure 2D),
the BRIDGE balloon (Phillips, San Diego, CA) was used in 5 institutions
(13\%), with transesophageal echocardiography (TEE) and intracardiac
echocardiography (ICE) used in 15 (39\%) and 6 (16\%) institutions,
respectively. Most respondents reported a cardiovascular surgeon was
either in the procedure room (46\%) or on call within the institution
(46\%).

Proposed clinical scenarios

Answers to proposed clinical scenarios (including high-risk lead
extraction procedures the management CIED pocked infections and
malfunctioning leads) were received from the 42 respondents who
performed lead extraction. Although the majority of respondents (30,
71\%) had no specific clinical scenarios in which lead extraction would
be avoided, 10 (24\%) respondents reported avoiding lead extraction in
patients over 80 years of age (3A). In cases of device related pocket
infection, total capsulectomy was performed by 24 (57\%), with 9 (24\%)
reporting not performing capsulectomy (figure 3B). In pacing dependent
patients with isolated pocket infection (figure 3C), a new device was
implanted only after consultation with the infectious disease specialist
by 18 (43\%) of respondents, with 5 respondents (12\%) reporting
implantation of a new device during the same procedure. In patients with
malfunctioning pacemaker or ICD leads, lead abandonment within the
generator pocket (with implantation of a new lead) was routinely
performed by 3 respondents (7\%), while 30 (71\%) respondents basing
their decision on a case-by-case basis after analyzing individual
patient characteristics and comorbidities (figure 3D)

\textbf{Discussion}

During the last two decades, the number of CIEDs implanted has increased
steadily as technological advances have allowed a wider range of
conditions to be treated with implantable devices. Moreover, the number
of dual chamber vs single chamber pacemakers, along with the use of
cardiac resynchronization devices has also increased (9-12). As such,
not only has the number of CIED implantations but also the number of
implanted leads has increased. This has led to a higher number of lead
related complications, mainly infection, and a greater number of TLE
procedures performed.

This is the first Latin American survey on TLE. Although smaller than
previous surveys (13-15), answers were received from 48 respondents from
44 different institutions (8 different countries). As such the survey
provides valuable information on the current practice of lead extraction
in our continent. Importantly, although TLE is performed in several
institutions in Latin America, most (66\%) report a low procedural
volume (i.e., less than 10 procedures per year). This percentage is
higher than that reported in the US (in which less than 20\% of
institutions performed \textless{}10 lead extraction procedures per
year) and the first European lead extraction survey (in which 40\% of
institutions performed \textless{}10 procedures each year)(15)
demonstrating a low use of TLE in the continent. Several possible
reasons exist for this finding: high cost of lead extraction tools, a
perceived higher risk for complications (as evidenced by a reluctance to
perform TLE in patients older than 80 years old in 22\% of respondents),
and a lack of proper training/knowledge (16). Unfortunately, the number
of implant procedures and the infection rate in Latin America is
currently unknown but taking into consideration European guidelines
which estimate the need of TLE as 1.5 times the infection rate (17), a
significantly higher number of lead extraction procedures is expected.
Lack of public financing in many Latin American countries has a
significant impact on CIED use and waiting times (18), and as such
should also impact the use of TLE techniques. Implementation of training
programs, along with a reduction in costs associated with TLE tools
could have positive impact on the number of lead extraction cases
performed. Taking into consideration that low procedural volume (defined
in the ELECTRa registry as less than 30 lead extraction procedures per
year) is associated with a significant increase in procedural mortality,
efforts should be made to increase training and to perform lead
extraction procedures only in high volume centers (19).

Although most institutions (73\%) used mechanical rotating sheaths
(which is similar to what was found in the European survey)(13), 13.5\%
of institutions reported the use of laser sheaths. This is particularly
surprising in latin america, taking into consideration the higher cost
of laser sheaths (20), with procedural success rates similar to those
reported with current mechanical rotating sheaths (21-23). In fact, in
the recently published PROMET study laser sheaths were almost entirely
abandoned in favor of mechanical rotating sheaths due to lower costs and
similar effectiveness (24). Regarding safety measures, cardiac surgeons
were included (either in room or within the institution) by 92\% of
respondents, similar to what has been described in the ILEEM survey (25)
but higher than reported in the US survey (in which a surgeon was not
identified in 25\% of lead extraction procedures)(14). Importantly,
other safety measures including TEE (39\%) ICE (16.2\%) and the BRIDGE
balloon (13.5\%) were used in a significant number of institutions.

Regarding the proposed clinical scenarios, the number of respondents who
perform complete capsulectomy in CIED related infection is lower than
that reported in a recent worldwide survey (57\% vs 76\%)(26). This is
in line with the most recent guidelines, in which capsulectomy is not
recommended as routine practice (27). Elderly patients (i.e., those
older than 80 years of age) were considered to be at high risk of
procedure related complications and 24\% of respondents routinely
avoided extraction in this patient population. Indeed, extraction
procedures in elderly patients have been found to be significantly
associated with a higher periprocedural mortality (2.5\% in 18--44 years
compared to 5.3\% in 85+ years, P \textless{} 0.001) in the US (28).
Finally, regarding malfunctioning leads, 71\% of respondents would base
their decision (i.e., lead abandonment or extraction) on individual
patient characteristics. This is similar to what has been described in
previous European surveys, in which malfunctioning lead management was
strongly determined by patient's age, the presence of damaged leads and
lead dwelling time (29).

Recently, the results of the largest prospective lead extraction
registry in Latin America were published, demonstrating the safety and
effectiveness of lead extraction in a large volume center (30). Future
efforts should thus be focused on increasing the number of centers
performing high volume lead extraction, as this study demonstrates
results comparable to those published in literature can be achieved.

\textbf{Limitations}

Our results have limitations to be considered. Although the survey was
sent using the LAHRS database, it is possible that several practitioners
from high volume centers failed to answer the survey. Additionally,
since the survey was sent in English, this could have also limited the
number of possible physicians willing to answer the survey. This could
have reduced the number of answers received. Finally, most answers were
received from Colombia and Brazil (66.7\% of total answers), and as such
other countries may be under-represented even though this type of
procedures are known to be performed.

\textbf{Conclusions}

This survey is the first attempt to obtain information on current
practices involving TLE in Latin America. According to our results, TLE
is performed in select centers in Latin America, with most centers
having a low procedural volume (\textless{}10 procedures per year). As
observed in other surveys, mechanical rotational sheaths are the most
frequently tool used, with current management techniques closely
resembling what is described in current guidelines. Results from this
survey could be used as guidance towards the creation of a future
prospective registry which could allow comparison of clinical outcomes
using different extraction techniques and the implementation of quality
improvement strategies.

\textbf{Tables and Figures}\selectlanguage{english}
\begin{longtable}[]{@{}l@{}}
\toprule
Name of the institution you most of the time work in (OQ) In which
country do you live in? (MC, SA) What is your specialty? (MC, SA) How
many years have you been practicing in your current specialty? (MC, SA)
Are you a member of LAHRS? (MC, SA) How many lead extractions are done
each year in your institution? (MC, SA) In patients with malfunctioning
pacemaker or ICD leads, which of the following best describes your
current approach (MC, SA) In patients with pocket infection or device
extrusion without bacteremia or endocarditis, which of the following
best describes your current approach (MC, SA) Do you currently perform
lead extraction? (MC, SA) Who usually performs lead extractions in your
institution? (MC, SA) Is lead extraction usually performed under general
anesthesia? (MC, SA) Which tools do you most frequently use for lead
extraction? (MC, MA) During the procedure, which of the following do you
use (MC, MA) In patients with a device related infection, do you perform
capsulectomy? (MC, SA) In patients with device related pocket infection
who do not have bacteremia or infective endocarditis and are pacing
dependent, how many days after lead extraction do you implant a new
device? (MC, SA) In which of the following scenarios do you AVOID
performing lead extractions (MC, MA)\tabularnewline
\midrule
\endhead
Table 1: Survey questions and type of answer expected. Abbreviations:
OQ: open question; MC: Multiple choice; SA: single answer; MA: multiple
answer.\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.} A: Number of respondents per
country\textbf{.}Although answers from several countries were received,
the majority of respondents were either from Colombia or Brazil. Most
respondents were electrophysiologists (B), with 70\% having more than 10
years of experience. Abbreviations: MX: Mexico; CO: Colombia; VE:
Venezuela; BR: Brazil; CL: Chile; AR; Argentina; UY: Uruguay.\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image2/image2}

\end{center}
\end{figure}

\textbf{Figure 2.} Information from 44 different institutions was
obtained. A: Number of procedures performed per institution. B: In most
institutions, lead extraction is performed by electrophysiologists. C:
Most institutions rely on mechanical lead extraction tools, with only 5
institutions (13\%) using laser powered sheaths. D: Safety measures used
during lead extraction procedures. Eighty-seven percent of respondents
reported cardiovascular surgeons were present either in room or on call
within the institution. Abbreviations: CV: cardiovascular; TEE:
transesophageal echocardiography; ICE: intracardiac echocardiography.\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image3/image3}

\end{center}
\end{figure}

\textbf{Figure 3.} Respondents' answers to proposed clinical scenarios,
including reasons to avoid lead extraction (A), use of capsulectomy
during lead extraction procedures in device related infections (B), time
to reimplantation in pacemaker dependent patients who have isolated CIED
pocket infection (i.e., without bacteremia or endocarditis) (C) and
approach to patients with malfunctioning pacemaker or ICD leads.
Abbreviations: ID: infectious disease; CIED: cardiac implantable
electronic device; ICD: implantable cardioverter defibrillator.

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