Changing landscape of complex lead extractions: need for patient
tailored use of armamentarium for very old leads
Arif Elvan, MD, PhD, FESC, FEHRA
Isala Heart Centre, Diagram Research, Zwolle, The Netherlands
Funding: None
Conflict of interest: None
The numbers of implanted cardiovascular implantable electronic devices
(CIED) and leads increased tremendously in the past decades due to an
expansion of indications and progressive ageing of the population. The
increased demand for complex transvenous lead extractions (TLE) is
mainly related to a higher relative incidence of CIED infections,
malfunction of leads and the increased need for upgrading or revision of
devices. Moreover, the landscape of lead extraction is changing in time
with a relative increase in the proportion of old leads with a dwell
time of ≥10 years (1, 2). The growing impact of these complex TLEs on
the utilization of the health care system has driven dedicated invasive
cardiac electrophysiologists and engineers to improve strategies and
tools to enable operators to perform lead extractions in a safe,
effective and patient-centered way, minimizing risks of morbidity and
mortality. We all know that chronically implanted leads may develop
extensive fibrous or calcified adhesions around the surrounding
structures and require more complex extraction techniques. Of note, the
ageing of leads is associated with decreased procedural and clinical
success rates and increased risk of lead extraction related
complications (1, 2, 3). Currently, the techniques and armamentarium
used in the extraction of leads include traction, counter traction,
locking stylets, telescoping sheaths, and powered rotational mechanical
and laser sheaths.
In this issue of the Journal of Cardiovascular Electrophysiology, Issa
(4) investigated success and complication rates of complex TLE of very
old leads, defined as leads with a dwelling time of ≥20 years compared
with younger leads. The indications for TLE were mainly related to
pocket (58.9%) and systemic infections (33.9%), and in a minority of
patients TLE was performed for other non-infectious indications.
Although clinical success was very high in the current study (97.1%),
this high clinical success implicates that small residual parts were
regarded as a satisfactory result, while non-extracted remnants can be
of clinical importance, especially in patients with lead endocarditis.
Therefore, the complete procedural success constitutes an important
metric rather than clinical success, particularly in patients with
infectious TLE indications, in whom extraction of the whole system
without any remnants should be the ultimate procedural endpoint.
Furthermore, in the study by Issa (4), patients were treated by a single
experienced lead extraction specialist in a high-volume center. The
results of this study cannot be extrapolated to less experienced
operators or low volume centers. This study underlines the necessity of
concentrating lead extractions to high-volume centers to provide the
best care for these patients. Some single center series reported very
low complication rates, which does not reflect potential complications
that might be encountered during a complex lead extraction procedure,
especially when performing extraction of very old leads with a dwelling
time of ≥20 years. It seems reasonable to advocate that all lead
extractions should be reserved to experienced centers with a thoracic
surgeon standby during complex lead extraction procedures. It is, to my
personal opinion, important to emphasize this issue instead of giving
space for low volume centers to perform some of the expected “easy”
lead extractions.
Moreover, in the study by Issa (4), the laser sheath was the primary
extraction tool used in the majority of the ≥20 years old leads and
mechanical sheaths or femoral snares were only used after failure of
laser sheaths. Complete procedural success was lower in the group of
patients with very old leads compared with leads with a dwelling time of
less than 20 years (90.7% versus 98.5%). However, angiography of the
subclavian vein was not a standard routine procedure in all patients. It
seems reasonable to incorporate venous angiography as a standard
procedure in the workup for TLE (5). Of note, the complexity of the TLE
in the group with leads less than 20 years old was very heterogeneous.
It is remarkable that 55% of the leads required complex extraction
techniques, whereas 45% of these leads could be extracted with manual
traction only in this group of patients with less than 20 years old
leads, highlighting the nonbinary nature of the extent of adhesions of
aging leads to surrounding structures. Despite advances in lead
extraction techniques, extraction of older leads in a safe and effective
way remains challenging. Issa (4) demonstrated that complex TLE can be
performed successfully and safely by a skilled and experienced operator
in a specialized center. The rate of major complications was 5.6%
including 1 death. These results are in line with previous publications
(5, 6, 7).
This latter study (4) underlines the importance of the use of
combination of multiple extraction tools in enhancing procedural success
rates. Especially in leads with a dwelling time of ≥20 years, there is
an increased risk of extraction failure or incomplete success. Issa (4)
primarily used laser sheaths while others used the powered mechanical
sheath as the primary extraction tool. Several reports describing the
results of case series were published on the success and complication
rates of lead extractions with the use of mechanical sheaths (5, 6. 7).
These studies described the results of case series. Moreover, Migliore
et al (7) reported that complex lead extractions using the Evolution RL
bidirectional rotational mechanical sheaths and ancillary tools in a
systematic stepwise approach were effective and safe.
The use of dedicated extraction tools and techniques yielded reported
major adverse event rates of 2-3% with a mortality of 1% in previous
studies (3, 5, 6, 7). In some previous reports, only powered mechanical
sheaths were used with comparable results (5, 6, 7). The currently
available armamentarium for complex lead extractions including laser
sheaths, powered mechanical rotational sheaths and femoral snares
enables operators to tailor the procedure in order to enhance procedural
and clinical success rates. However, there is a lack of direct
comparative data regarding risks and benefits of laser sheath compared
with powered mechanical sheaths and femoral snares.
Issa (4) performed analyses of retrospective data which should be
regarded as exploratory and hypothesis generating. Nevertheless, this
study provides data and conveys messages that are important to the
clinical practice. The main finding is that transvenous extraction of
leads with a dwelling time ≥20 years is associated with a considerable
risk of major complications, even in the hands of an experienced
operator and in the setting of a high-volume center. This study
highlights the need for concentration of complex lead extractions to a
selected number of highly specialized centers.
Although, direct comparison of the available strategies and techniques
has not been performed yet, these studies need to be performed in the
near future. Clinicians need guidance based on firm evidence regarding
comparative efficacy or safety of bidirectional powered mechanical
sheaths and laser sheaths and femoral snares.
There are no randomized trials comparing different extraction
strategies. The current recommendations are based on outcome data
derived from various case series.
Therefore, international collaboration, merging of databases and
ultimately randomized trials are crucial to gain more insight and to
better delineate the incremental values of the available lead extraction
tools and techniques.
The innovations in the field of complex TLE techniques and tools will
continue. In the meantime, the extraction of chronically implanted leads
remains a complex procedure associated with major complications
including mortality, mandating concentration to specialized centers and
standardized metrics for monitoring procedural and clinical outcomes.