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 procedures 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 and coronary sinus leads were
more common in the TightRailTM group
(p<0.05). The most common TLE indications were lead
malfunction (57.9%) in the TightRailTM group and
CIED-related infection (49.1%) in the Evolution®group, 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 was achieved in 259 (85.8%)
and 270 (89.4%) patients using mechanical dilator sheaths alone. 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. 88%,
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). 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). The rescue snaring system
was only failed in one patient in the TightRailTMgroup due to trapping of 3 electrodes in the right femoral vein that was
extracted surgically. Three patients failed with mechanical dilator
sheaths without using a rescue snaring system (n=2 in the
TightRailTM group vs. n=1 in the
Evolution® group). Among two 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 were 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 surgery. 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). The 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 was a statistically significant difference between
Evolution® and TightRailTM groups
which were thought to be due to a sicker population with more
hypertension, diabetes mellitus, CAD, HFrEF, NYHA class II-IV, and lower
LVEF of TightRailTM group compared to
Evolution® group (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.