Patients with leadless cardiac pacemakers experienced fewer short-term and midterm complications than patients with standard transvenous pacemakers, according to the results of a study published in Heart Rhythm.
Complication rates from leadless pacemakers were obtained from the prospective, nonrandomized, multicenter LEADLESS Pacemaker IDE Study (Leadless II; ClinicalTrials.gov Identifier: NCT02030418) trial and compared with those of transvenous pacemakers from the Truven Health MarketScan Research Databases. Complications were evaluated from device implantation until 18 months, and were classified into either short-term (≤1 month) or midterm (1-18 months).
Of the 718 patients with leadless pacemakers in the Leadless II trial, short-term complications occurred in 5.8%. These included dislodgments, vascular-related events, and pericardial effusion both with and without tamponade. Midterm complications were low (0.56%), and no infections were reported in the leadless cohort.
When compared with the 9376 patients with nonleadless transvenous pacemakers, short-term complications were significantly reduced in the leadless group (5.8% v 9.4%; P =.0095). However, there was a higher rate of pericardial effusions (1.53% v 0.35%; P =.0056) in the leadless group. In the transvenous cohort, 25 patients experienced infections. Similar to the short-term complications rates, midterm complications were lower in the leadless cohort (0.56% vs 4.94%; P <.001).
The study authors wrote, “The overall reduction in both short- and mid-term events was driven by a virtual elimination of lead, pocket, and infectious complications.”
They also noted, “The [transvenous pacemaker] complications in this study are consistent with an extensive body of literature, showing that lead-related problems, thoracic trauma, vascular injury, pocket hematoma, and infection drive short-term complications and that lead-related problems dominate the mid-term complications.”
Cantillon D, Dukkipati SR, Ip JH, et al. Comparative study of acute and mid-term complications with leadless and transvenous cardiac pacemakers. Heart Rhythm. 2018;15(7):1023-1030.