TransvenoUs lead exTRaction and post-ExtraCTion venous occlusion
A single centre, prospective cohort study

Little is known about venous occlusion post-TLE. Post CIED implantation an
incidence of 8-21% of occlusion of the subclavian or brachiocephalic vein is
seen (10), however the incidence of pacemaker induced superior vena cava
syndrome is reported to be very low, at 0.03-0.4%. Post-extraction however,
given the often disruptive nature of freeing the leads from the veins with
extraction tools, lead extraction might predispose to thrombosis and venous
obstruction in even higher rates. Bracke et al (9) found an 8% incidence of new
symptoms suggestive of venous occlusion following lead extraction in patients
with a previously patent entry vein. No Venogram post-extraction was performed.
Given the underestimation of occlusion by clinical symptoms, the incidence of
total occlusion could still be higher. Recent study (11) showed 15.6%
microscopic vein injuries during lead extraction, especially when a laser
sheath is used. This is representative for the vascular injury inflicted during
TLE.

Main objective is to compare the incidence of subclavian vein thromboses after
TLE by manual traction alone versus TLE with use of the mechanical rotational
dilator sheath in case of fibrous adhesions hampering extraction by manual
traction alone.
Secondary objective is to assess safety and long term follow-up in patients
after TLE and comparison with historical data.

Single Centre prospective cohort study designed to enrol 201 patients

A venogram is an x-ray test that involves injecting contrast material into a
vein to assess the lumen of the vein. Although the procedure is relative save,
X-ray and venous injection has risks. Contrast nephropathy is a generally
reversible form of acute kidney injury (AKI) that occurs soon after the
administration of radiocontrast media. The increased creatinine is generally
observed within 24 to 48 hours after contrast exposure and is mild. The
creatinine usually starts to decline within three to seven days. The doses of
contrast is relatively low.
In the current guidelines there is no recommendation for standard care after
TLE. In our hospital we frequently assess the subclavian vein with a venogram
to exclude venous thrombosis, from 2014 on post procedure venogram was
frequently performed. In this study we will regulate the care for lead
extraction patients by performing a routine venogram post TLE in order to
assess predictors for venous thrombus/embolus.