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.