Introduction:
There are no randomized controlled trials that compared the outcomes of leadless pacemaker (L-PPM) implantation with transvenous pacemaker (TV-PPM) and there is scarcity of data on real world outcomes.
Methods:
We queried National Inpatient Sample to identify all adult patients who had primary discharge diagnosis of conduction disorders or tachy-arrhythmias and excluded patients who had a concomitant procedure for valve replacement, coronary artery bypass grafting, ablation and/or cardiac implantable electronic device removal so that complications can be attributed to the pacemaker implantation. We included only procedures from November 2016 to December 2017 as Micra was the only available L-PPM during that period. For the comparison cohort we selected patients, during the same time period, who had a procedure code for single chamber pacemaker implantation in conjunction with right ventricular lead placement. We performed 1:1 propensity score matching and the variables used for matching are marked with asterisk in Table 1. All the codes used to identify complications has been previously validated from the Micra Post-approval registry and Coverage with Evidence Study.
Results:
Total of 1,305 patients for L-PPM and 13,905 patients in the TV-PPM group were included. Baseline characteristics with standardized mean difference before and after matching are shown in Table 1. Briefly, patients in L-PPM group were younger but had higher co-morbidities compared to TV-PPM group. The complications before and after matching are shown in Table 2.
Conclusions:
In conclusion, we found no significant difference between in-hospital complications after propensity score matching, with the exception of deep venous thrombosis. There was no difference between length of stay but cost for L-PPM was significantly higher. In this real-world analysis, we found that the leadless PPM implantation is safe in comparison to transvenous PPM.
Leadless Pacemaker and Temporary Transvenous Wire Entanglement Requiring Percutaneous Extraction
