RESULTS
Between July 2009 and June 2018, a total of 566 endovascular leads were
extracted from 302 patients [Evolution® group (133
patients with 233 leads) and TightRailTM group (169
patients with 333 leads)]. The baseline demographic, clinical and
laboratory data of the study groups were represented in Table 1.
Diabetes mellitus, hypertension, coronary artery disease, and HFrEF were
more prevalent in the TightRailTM group
(p<0.05).
The details of CIEDs and TLE procedure were shown in Table 2. The mean
number of extracted leads per patient was 1.8±0.73, and the median lead
dwell time was 5.0 (0.6-33) years. All ICD leads were of dual coils, and
all coronary sinus electrodes have a passive fixation mechanism.
Re-implantation was performed in 216 (71.5%) patients during the index
TLE procedure. Leads with active fixation mechanism and coronary sinus
leads were more common in the TightRailTM group
(p<0.05). The most common TLE indications in the
Evolution® and TightRailTM groups
were lead malfunction (57.9%) and CIED-related infection (49.1%),
respectively (p<0.05). Among different sheath sizes, 13F in
the TightRailTM group and 9F in the
Evolution® group were more frequently used
(p<0.05).
Complete procedural and clinical success were achieved in 259 (85.8%)
and 270 (89.4%) patients using mechanical dilator sheaths alone,
respectively. There was no statistically significant difference between
Evolution® and TightRailTM groups in complete
procedural (86.9% vs. 84.2%, p>0.05) and clinical success
(90.6% vs. 80%, p>0.05) (Figure 1). Rescue snaring system
was used because of lead fracture in 29 patients (9.6%) (11.2% in
Evolution® vs. 8.2% in TightRailTM group, p=0.286).
Totally, clinical success was achieved in 298 patients (98.6%) using
both mechanical dilator sheath and snaring system (99.2% for
Evolution® group vs. 98% for
TightRailTM group). Rescue snaring system was only
failed in one patient in the TightRailTM group due to
trapping of 3 electrodes in the right femoral vein that were extracted
surgically. Three patients failed with mechanical dilator sheaths
without using rescue snaring system (n=2 in
TightRailTM group vs. n=1 in
Evolution® group). Among 2 patients in the
TightRailTM group, the procedure was terminated in one
patient due to the loss of consciousness during TLE in whom intracranial
hemorrhage and subsequent death was observed, and in another patient the
electrode was left in the right ventricle due to failure with rescue
tools. In one patient in the Evolution® group, a major
vascular injury that required surgical intervention developed, and the
one electrode was extracted completely by surgically. Major and minor
complications were observed in 2.3% (n=7) and 9.3% (28) of patients
which were similar among study groups (p>0.05) (Figure 2 &
3). Efficacy and safety outcome data of the study groups were shown in
Table 3.
At median 36.6 (0.2-117.5) months follow-up duration [74.6 (0.6-117.5)
months for Evolution® group vs. 25.8 (0.2-63.5) months
for TightRailTM group, p=0.001], all-cause mortality
was observed in 73 patients (25.6% in Evolution®group vs. 23.1 in TightRailTM group, p=0.616). When
the survival curves of both groups are evaluated with log-rank test,
there is a statistically significant difference between
Evolution® and TightRailTM groups;
because of the survival duration of Evolution® group
was more prolonged than TightRailTM group due to that
Evolution® group had longer follow-up
(p<0.001) (Figure 4)
Baseline demographic, clinical, laboratory and procedural
characteristics of patients according to the procedural failure and
all-cause mortality were shown in Supplementary File 2 and 3,
respectively . In multivariable logistic regression analysis, the
presence of HFrEF (OR: 5.73, 95% C.I.: 1.49-22.0, p=0.011), increased
baseline aPTT level (OR: 1.09, 95% C.I.: 1.03-1.17, p=0.006) and
baseline GFR level <60 ml/min/1.73m2 (OR:
2.81, 95% C.I.: 1.12-7.08, p=0.028) were associated with a higher risk
of all-cause mortality. Furthermore, baseline leukocyte count (OR: 1.20,
95% C.I.: 1.02-1.42, p=0.028), number of extracted leads (OR: 2.91,
95% C.I.: 1.45-5.86, p=0.003) and lead dwell time (OR: 1.08, 95% C.I.:
1.003-1.162, p=0.041) were found as independent predictors of TLE
procedural failure.