Minimally-invasive upper extremity versus lower extremity for accessory access sites during transcatheter aortic valve implantation

During a transcatheter aortic valve implantation (TAVI) procedure, a temporary
pacemaker wire is inserted via the femoral or jugular vein to perform rapid
pacing during pre- or post-dilation or in case of the use of a
balloon-expandable valve. Pacing can also assist in proper valve positioning
and provides a direct back-up in case of conductance disorders during the
procedure. The first 24-48 hours after TAVI, this temporary pacemaker is kept
in situ in order to overcome post-procedure conduction disorders.

The preferred access site (nowadays) for this temporary pacemaker is the
femoral vein. Given the large diameter of the femoral vein, access site
hematomas are common. In addition, as long as this temporary pacemaker is in
situ, the patient is not allowed to mobilize in order to prevent dislocation of
this pacemaker wire. This potentially leads to delayed mobilization and longer
immobility of the patient.

Besides the venous access site for the aforementioned temporary pacemaker, two
more access sites are needed for a TAVI procedure: the artery through which the
new bioprosthetic aortic valve is placed (i.e. the TAVI access site) and the
artery through which the pigtail catheter with contrast agent is placed (i.e.
the diagnostic access site). In general, the preferred diagnostic access site
is the femoral artery. However, also hematomas around the femoral artery when
used as diagnostic access site are common. We hypothesize that the use of the
radial artery as diagnostic access site causes less access site hematomas as
compared to the femoral artery. The same applies for using the brachial vein
instead of the femoral vein as temporary pacemaker access site. In addition, we
hypothesize that the use of the brachial vein for the temporary pacemaker
facilitates earlier mobilization and leads to a shorter duration of
hospitalization when compared to using the femoral vein.

To assess the safety and efficacy of a *minimally-invasive upper extremity*
approach (radial artery for pigtail catheter and brachial vein for temporary
pacemaker when not pacing over the left ventricular stiff wire OR radial artery
and pacing over the LV stiff wire versus the standard *lower extremity*
approach (femoral artery for pigtail catheter and femoral vein for temporary
pacemaker when not pacing over the LV stiff wire) OR femoral artery and pacing
over the LV stiff wire.

This is a prospective, multicenter, randomized trial. All patients undergoing a
transfemoral TAVI and who comply with the inclusion and exclusion criteria will
be randomized in a 1:1 fashion between *minimally-invasive upper extremity*
group (experimental arm) and *lower extremity* group (comparative arm).

Eligible patients will be randomized in a 1:1 ratio to either the *minimally-
invasive upper extremity* group (i.e. radial artery for pigtail catheter and
brachial vein for temporary pacemaker when not pacing over the left ventricular
stiff wire OR radial artery and pacing over the LV stiff wire versus the
standard *lower extremity* approach (femoral artery for pigtail catheter and
femoral vein for temporary pacemaker when not pacing over the LV stiff wire) OR
femoral artery and pacing over the LV stiff wire.

There is no additional risk for patients associated with study participation,
besides the risk of the TAVI procedure itself.