Implant rates of cardiovascular implantable electronic devices (CIED)
and leads have increased progressively due to expanding indications
(1-3). Moreover, a higher relative incidence of CIED infections,
malfunction of leads and the need for upgrading devices is observed,
resulting in an increased need for transvenous lead extraction (TLE)
(4-10). Although manual traction is an effective technique to remove
recently implanted leads, chronically implanted leads develop fibrous
adhesions around the surrounding structures and require more complex
extraction tools (11-14). The techniques and tools used in the
extraction of leads include traction, counter traction, locking stylets,
telescoping sheaths, and powered mechanical and laser sheaths. Over the
25 years of use of sheaths and locking stylets, the majority of papers
has shown major adverse events of 2% and mortality of 1% (4, 7,
8,11-15). With the introduction of laser, Evolution, and other
techniques, success rates have increased and procedure time has
decreased, even though complications have remained fairly stable.
Efficacy rates are often hampered by broken RV lead tips or larger
parts, because of the absence of a dedicated tool for cutting adhesions
within the apex of the right ventricle. Possibly, the fact that the
locking stylet sometimes can only be advanced up to the anode and not to
the final end of the RV lead contributes to this. Moreover, in some
cases, the locking stylet even can’t be advanced up to the anode,
causing breakage of the lead more proximal. Advancing a laser sheath
(SLS-II laser sheath) beyond 1cm from the tip of the RV-lead is off
label use and cutting through fibrous tissue up to the tip of the RV
with the Evolution is discouraged, because of the possibility of
perforation of the right ventricle (16,17). The Evolution RL cuts
bidirectional and prevents piling up of lead- and adhesive material,
possibly enabling usage of the sheath up to the myocardium and
facilitating removal of the RV-tip in case of adhesions. Also the
RL-sheath has a crown cutting edge tip, which gives the sheath more
tip-control and possibly less chance of perforation of the right
ventricle (see figure 1).
We therefore assessed the safety and efficacy of extraction up to the
endocardium, when clinically needed.Figure 1: Picture of the Evolution R/L and old EvolutionFigure 1: Left shows the RL-sheath has a crown cutting edge, which gives
the sheath more tip-control and less chance of perforation of the right
ventricle in compare to the right picture with the old Evolution sheath
with rotational tip.MethodsFrom 2009 to 2018, all lead extractions in the Isala Heart Centre
(Zwolle, The Netherlands) requiring the use of a hand-powered mechanical
Evolution system were examined from a prospective registry. From 2013
onwards, the Evolution sheath was replaced by the Evolution RL sheath.
This sheath is very similar; however, the RL sheath has a crown cutting
edge and a bidirectional cutting tip, whereas the previous Evolution
sheath had only a unidirectional cutting tip. To be able to investigate
the incremental ability of the new sheath to extract leads that have
adhesions up to the tip, we divided the study population in 4 groups:
Group A1: patients with an RV lead extraction (pace/sense or high
voltage) with the first generation Evolution, with adhesions up
to the tip. Group A2: patients with an RV lead extraction (pace/sense or
high voltage) with the first generation Evolution, withoutadhesions up to the tip. Group B1: patients with an RV lead extraction
(pace/sense or high voltage) with the novel Evolution R/L, withadhesions up to the tip. Group B2: patients with an RV lead extraction
(pace/sense or high voltage) with the novel Evolution R/L,without adhesions up to the tip.
All procedures were performed in the operating room or cardiac
catheterization laboratory by an experienced team specialized in lead
extractions. Indications and complications of TLE were defined according
the current guidelines (4,7,8). Indications for lead extraction were
classified as infection, lead malfunction, and miscellaneous.
Transvenous lead extraction due to infection included endocarditis, with
or without signs of vegetation on the leads, and generator pocket
infections. Persistent fever or recurrent bacteremia without an apparent
focus, despite profound examination, was also an indication for
extraction of the entire system since a cardiac device infection could
not be excluded. Lead malfunctions were established on the basis of
clinically significant alterations in pacing, sensing, and/or lead
impedance parameters.
Lead extraction was performed using a standard stepwise approach in all
patients (18). All patients underwent TLE in electrophysiology
laboratories or hybrid operating room, with continuous
electrocardiographic and arterial blood pressure monitoring. The
procedure was performed under sedation or general anesthesia and using
Transesophageal echocardiographic guidance depending on patient status
and physician preference. In patients dependent on bradycardia support,
a temporary pacemaker (PM) was inserted from the femoral vein. Standby
cardiac surgery for the treatment of emergency complications was always
available. A stiff guidewire from the right femoral vein to the right
internal jugular vein for potential use of the bridge occlusion balloon
(Spectranetics, Colorado Springs, CO, USA) in case of vascular
lacerations was deployed at the discretion of the physician and if
available in the center.
After leads were dissected free from the scar tissue in the pocket, the
anchor sleeves were removed and the active fixation mechanism was
retracted. After that, controlled manual traction was attempted. If the
lead was not easily removed, then an appropriately sized locking stylet
(Liberator Universal Locking Stylet, Cook Vascular, USA) was placed, and
a silk suture was tied around the lead to bind the insulation to the
conductors and to keep the insulation from bunching in front of the
sheath. Manual traction was again attempted with the locking stylet in
place, making sure not to disrupt the lead integrity. If still
unsuccessful, a hand-powered mechanical rotational dilator Evolution or
the Evolution R/L sheath was used. All patients underwent the procedure
under general anaesthesia supervised by a cardiac anaesthesiologist and
with continuous transoesophageal echocardiographic monitoring.
The Evolution hand-powered mechanical dilator sheath was replaced from
2013 onwards by the Evolution RL sheath. In our experience, the
Evolution RL reduces difficulty in cutting through fibrotic tissue and
advancing the sheath (14). In general, because of the risk of entrapment
of adhesive tissue in the Evolution sheath, we oversize the Evolution by
at least 2 French. In case of a dual coil shock, we oversize by at least
3 French. The operator pulls the handle of the dilator sheath, which
causes rotation of the cutting tip. The rotational mechanism of the
sheath permits movement along the lead body by cutting fibrous adhesions
via the distal metal tip, whereas the outer telescoping polymer sheath
protects the venous wall from the metal cutting tip while advancing over
the lead in the tracts free from adherences. When fibrous attachments
met, the cutting tip is uncovered from the outer sheath. Once the
fibrous attachments are cut, the outer sheath is advanced until another
area of attachment is encountered. Whenever an adhesion at the tip of
the right ventricle lead exists, we first position the outer sheath so
that the blunt end is directed toward the myocardium and we retract the
cutting part of the sheath. Then traction and countertraction was
applied with the outer sheath as by firmly holding the outer sheath one
centimeter from the heart wall and steadily pulling the Locking Stylet
back; the pacing tip will be pulled into the sheath. Rotation of the
sheath may help dislodge the tip. Traction on the lead and counter
traction was applied during approximately 2-4 minutes. If not
successful, in case of the Evolution, we accepted the lead residue in
situ. In case of the Evolution R/L we advance the sheath by cutting
fibrous adhesions up to the tip of the lead until the edge of the right
ventricle myocardium. After the release of leads from fibrous tissue,
the leads are pulled back into the sheath and removed. For a visual
overview of this procedure see figure 1.
In case of bystander leads we protect those with a stylet.
Complete success of the procedure was defined as the removal of all
targeted leads and all lead material from the vascular space without the
occurrence of any permanently disabling complication or procedure
related death. Clinical success was defined as the removal of all
targeted leads and lead material from the vascular space or retention of
a small portion of the lead (≤4 cm) in the absence of permanently
disabling complications. Failure of the procedure was defined as the
inability to achieve either complete procedural or (assumed) clinical
success, or the occurrence of any permanently disabling complication, or
procedure-related death. Major complications were defined as outcomes
that were life threatening, resulted in significant or permanent
disability or death, or required surgical intervention. Minor
complications were defined as events related to the procedure that
required medical intervention or minor procedural intervention. Cardiac
implantable electronic device related infections are categorized
according the HRS expert consensus (4).
The study was conducted according to the principles of the Declaration
of Helsinki. The study protocol was checked at the local institutional
review board, but since the study describes a standard care intervention
an official approval was not mandatoryFigure 2: sequential images of an extraction with strong
adhesions of the RV-lead
tipStatistical analysisAll variables are presented as mean±SD or as numbers with percentages,
where appropriate. Normality of distribution was assessed and means or
medians were reported accordingly. We grouped patients by the type of
Evolution sheath that was used (Evolution group vs. Evolution R/L
group). P-values between success rates in different groups were
calculated by the Chi-squared test or Fisher’s exact test, where
appropriate. Statistical analysis was performed using latest version of
SPSS statistical software.ResultsIn total, 209 patients underwent an extraction with the Evolution (n=57)
or Evolution R/L (n=152) of which 185 patients underwent an RV-lead
(pace-sense and/or high voltage) extraction and were included in the
analysis. In the Evolution group (Group A1 and A2: n=43) we
extracted a total of 43 leads (18 pace/sense-leads (41.9%) and 25
high-voltage-leads (58.1%)) and in the R/L group (Group B1 and B2:n=142) a total of 146 leads were extracted (48 pace/sense leads
(23.8%) and 98 high-voltage-leads (69.0%)). In 4 patients (all R/L
group) we extracted both a pace/sense- and a high-voltage-lead. The
baseline characteristics of the two different groups are shown in Table
1a. In both groups, patients were predominantly males with similar age
at time of extraction and similar systolic LV function. Patients in the
Evolution R/L group more frequently underwent extractions due to
dysfunction of the lead (50.0% vs 27.9%, p<0.001), whereas
in the Evolution group an infectious cardiovascular implantable
electronic device (CIED) (69.8% vs 26.1%, p<0.001) was the
main reason for extraction. Lead-age in the Evolution R/L group was
higher.
All leads were extracted through the superior subclavian approach.
Additional use of the femoral snare was not required because of our
stepwise approach with traction and countertraction with a high
successrate (14, 15) and a snare from a femoral approach enters the
right ventricle in a sharp angle, making advancing the femoral snare up
to the endocardium difficult and traction and counter traction less
effective.
The baseline characteristics of Group A1 versus Group B1 are presented
in Table 1b. Group A1 (first generation Evolution, with adhesions up to
the tip) compared to Group B1 (Evolution R/L, with adhesions up to the
tip) consisted of more infections, more pace/sense leads and younger
leads. In the groups A2 (first generation Evolution, without adhesions
up to the tip) and B2 (Evolution R/L, without adhesions up to the tip)
only lead extraction indications differs (Table 1c). Comparing the
Evolution and Evolution R/L we encountered a similar percentage of
adhesions of the RV lead tip (Table 2).
Complete success rate in Group B (n=142) was significantly higher than
group A (96.5 vs 76.7%, p=0.0354). When comparing Group A1 and B1,
patients with adhesions up to the tip of the RV, total complete success
is higher in the R/L group (61.1% vs 90.5%, p=0.0067) (table 3). These
differences are mostly due to a significant increase in complete success
rate of the Pace/sense leads in favor of the R/L sheath (table 4). Also,
when comparing with multivariate analyses, only the use of the R/L
Evolution significantly increases the complete success rate with an Beta
ratio of 0.340 (CI 0.097-0.0465, p-value=0.003) corrected for lead age,
gender and type of lead (table 5).
There were no deaths in our study population. There was no statistically
significant difference in major and minor complications between the two
groups (Table 6). Overall major complication rates were low (2/185;
1.1%). The minor complications in the Evolution group consist of minor
asymptomatic pneumothorax (n=2), managed with a drain, in all of the
patients. Also 2 puncture-site-related venous haematoma (n=2) were
managed conservatively. In the R/L type group we observed 2 major
complications with tamponade, in need of a thoracotomy and patching of
vena cava superior and left atrium. We did not need to use a bridge
occlusion balloon. In both cases the R/L evolution sheath was not
advanced up to the RV. In the R/L group with adhesions up to the tip of
the RV, we observed no major complications and 3 minor complications: 2
puncture-site-related venous haematoma (n=2) managed conservatively and
one asymptomatic pneumothorax, managed conservatively.
In the Evolution (Group A) we encountered 6 times clinical success due
to a RV-tip residue and one time failure due to a shockcoil stuck behind
clavicular bone. In the Evolution R/L (Group B) we encountered 4 times
clinical success due to a RV-tip residue and 2-times failure due to a
shockcoil, which was removed by sternotomy.DiscussionIn our present prospective single centre series, we studied the
feasibility, success and complication rates of lead extraction in case
of adhesions of the RV lead up to the lead tip. In a similar cohort of
patients, significantly higher complete success rates were achieved when
extracting right ventricular leads with adhesions up to the tip, with
the novel Evolution R/L sheath in combination with the novel strategy as
compared to the Evolution sheath. Furthermore, mechanical extraction
towards the endocardium was feasible, and no complications occurred due
to the rotational extraction mechanism of the R/L sheath when advancing
up into the endocardium.
Mazzone et al (18) also showed Lead extraction using the Evolution RL
bidirectional rotational mechanical sheath and ancillary tools in a
systematic stepwise approach was effective and safe, but using the
rotational tool up to the myocardium is discouraged.
At this moment, dedicated extraction tools for the specific situation
where the RV lead is strongly adhered, are limited. Advancing a laser
sheath (SLS-II laser sheath) beyond 1cm from the tip of the RV-lead is
off label use and cutting through fibrous tissue up to the tip of the RV
with the Evolution is discouraged, because of the possibility of
perforation of the right ventricle. Push and pull technique with
countertraction is the most accepted method up to now. Although in many
cases clinical success with a small residual part is a satisfactory
result it can be of clinical importance (e.g.: lead endocarditis) to
extract the whole system without any remnants.
Our study shows that the latter method can be facilitated by subtle
bidirectional cutting with the Evolution R/L. With the old Evolution we
only felt comfortable applying push and pull with the outer sheath and
avoided the usage of unidirectional cutting at the myocardial wall when
the tip of the leads was stuck. When using the novel R/L sheath,
advancing and cutting within the RV proved to be safe and effective.
In multivariate analyses, the use of the R/L Evolution sheath was
independently associated with complete success (P=0.003). A
significantly higher complete success rate was achieved in high voltage
leads compared to pace-sense leads, possibly due to better longitudinal
strength. In the R/L group the reason for clinical instead of complete
success, was mostly fracture of the RV lead 1-2 cm proximal to the tip.
Remarkably, in all these cases passive-fixation pacemaker lead was
present. No deaths occurred, and only a small and comparable percentage
of complications were present in both groups. In patients with strong
adhesions at the lead-tip that did not get loose after a few minutes of
traction/countertraction, were amenable for subsequent advancement of
R/L sheath up to the lead tip and myocardium, by applying rotational
cutting. This method proved to be feasible and safe, as no direct
complications were present related to this manoeuvre.
As with all research, our present report has limitations. The reported
data represent a single- center prospective registry, with a relatively
small number of patients. Complex extraction procedures are, however,
not frequently performed, and in the Netherlands, our tertiary
cardiology center is one of the largest extraction centers.
Direct comparison to other techniques was not performed; certainly,
these studies should be performed in the future, but are very complex to
realize. International cooperation and merging of databases are
essential to obtain more insight into this subject.ConclusionExtraction strategy with the bidirectional Evolution R/L sheath for
right ventricular leads with adhesions up to the endocardium is safe and
feasible, and associated with higher complete success than with the
classic Evolution sheath.