Safety profile of temporary permanent pacemakers
In this study, TPPM were associated with lower incidence of
complications, reflected by an adjusted odds ratio (OR) of 0.20
(P<0.001).
Temporary pacemaker insertion, although considered a routine and safe
procedure, is associated with significant complications. These
complications can be immediate (or procedure related) such as local
hematoma, pneumothorax, or access site infection. All patients with a
BTTP who developed access site infection or hematoma had femoral access.
Femoral venous catheterization is associated with increased risk of
infections compared to other catheterization access sites,(27) especially the subclavian vein, which was used
predominantly in the TPPM group. Utilizing the subclavian and jugular
veins as access sites may have reduced the incidence of these
complications in the TPPM cohort.
Delayed complications may be more life threatening than procedure
related complications, such as VTE, loss of capture and lead
dislodgment. All three complications happened significantly more
frequently in the BTTP group compared to the TPPM group.
We believe that a reduced ICU stay and patient mobility in the TPPM
cohort are the main reasons behind the lower incidence of VTE compared
to the control group. Early ambulation plays a major role in reducing
the incidence of deep vein thrombosis (DVT) during
hospitalization.(28) One prior study has also
demonstrated a lower risk of DVT in mobile patients with
TPPM.(29)
As mentioned earlier, active fixation of pacemaker leads significantly
decreases the risk of dislocation compared to passive
fixation.(6) In our study, we only reported clinically
significant lead dislodgement leading to loss of capture requiring
repositioning or replacement. Our finding that lead dislodgement was
significantly more common in the BTTP group (21.3% vs 8.2%) is
similar to the results from prior
studies. De Cock et. al showed a 5.5% prevalence of lead dislodgement
with TPPM (compared to 36.4% in BTTP).(8) This
specific study used the Medtronic Temporary Pacing Lead System Model
6416 that was recalled later in 2016, since these leads were not
compliant with standards set by the FDA and the International
Electrotechnical Commission (IEC) (U.S Food & Drug,
2016).(30) Braun et. al reported only one case of
dislodgement in their TPPM cohort compared to 24 in the control group.
In cases of pacemaker dependency such as unstable complete heart block,
loss of capture can lead to profound hemodynamic instability and
possible death.(31) Lead replacement or repositioning
requires catheterization lab activation, exhausting both financial and
personnel resources.
Importantly, patients with TPPM who were exclusively paced outside the
ICU did not have significantly different rates of complications compared
to the TPPM patients who were paced in the ICU setting. Hence, temporary
pacing with a TPPM can be safely executed outside an intensive care
setting.