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Observational Study
. 2025 Aug;22(8):e431-e437.
doi: 10.1016/j.hrthm.2025.03.1881. Epub 2025 Mar 10.

Comparison of 30-day complications between a tine-based and a screw-in helix fixation single-chamber ventricular leadless pacemaker: Results of a propensity score-matched analysis from a multicenter, nationwide registry

Pietro Palmisano  1 , Giovanni Rovaris  2 , Domenico Giovanni Della Rocca  3 , Paolo Della Bella  4 , Ennio Carmine Luigi Pisanò  5 , Lorenzo Mazzocchetti  6 , Zefferino Palamà  7 , Gabriele Dell'Era  8 , Antonio Strangio  9 , Antonio Dello Russo  10 , Vincenzo Paolo Caccavo  11 , Antonio Curcio  12 , Cosimo Mandurino  13 , Giorgio Spiniello  14 , Domenico Gianfrancesco  15 , Giovanni Caroli  16 , Massimo Grimaldi  11 , Giovanni Volpato  17 , Fabio Megna  18 , Giuseppe Patti  19 , Giuseppe Tricarico  7 , Stefano Guarracini  6 , Elena Marino  5 , Marzi Alessandra  4 , D'Angelo Giuseppe  4 , Ingrid Overeinder  20 , Elisabetta Montemerlo  2 , Giuseppe Campisi  21 , Giovanni Coluccia  22 , Antonino Nicosia  21
Affiliations
Observational Study

Comparison of 30-day complications between a tine-based and a screw-in helix fixation single-chamber ventricular leadless pacemaker: Results of a propensity score-matched analysis from a multicenter, nationwide registry

Pietro Palmisano et al. Heart Rhythm. 2025 Aug.

Abstract

Background: Medtronic Micra VR and Abbott Aveir VR are 2 single-chamber ventricular leadless pacemakers (L-PMs) currently available in clinical practice. They differ in their design, fixation mechanism (tine-based fixation for Micra VR, screw-in helix fixation for Aveir VR), and implantation technique. Few comparative safety data are available for these L-PMs.

Objective: We aimed to compare the rate of acute procedure-related complications of patients undergoing Aveir VR vs Micra VR implantation.

Methods: A prospective, multicenter, observational registry enrolled consecutive patients who underwent Aveir VR or Micra VR implantation. The rate and nature of device-related complications at 30-day follow-up were analyzed and compared between the groups. Individual 1:1 propensity score matching of baseline characteristics was performed.

Results: A total of 1141 patients (75.9 ± 14.8 years; 60.2% male) were enrolled: 211 Aveir VR and 930 Micra VR. Propensity score matching yielded 189 matched pairs. In the matched cohort, the risk of device-related complications at 30 days of follow-up of the 2 L-PMs was similar (2.1% vs 2.1%; P = 1). Device migration (1.6% vs 0.5%; P = .315) and vascular complications (0.5% vs 1.1%; P = .562) were the most frequent complications, with no significant differences between the groups. Cardiac perforation was rare (1 case in the Micra VR group, no cases in the Aveir VR group).

Conclusion: The risk of acute device-related complications associated with Aveir VR and Micra VR L-PM implantation was similar. These findings suggest that despite differences in design, fixation mechanism, and implantation technique, these 2 devices appear to have a similar short-term safety profile.

Keywords: Aveir VR; Cardiac perforation; Complications; Device migration; Leadless pacemaker; Micra VR; Vascular complications.

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Conflict of interest statement

Disclosures A.D.R.: consultant for Abbott. P.D.B.: speaker fees from Abbott, Boston Scientific, and Biosense Webster. D.G.D.R.: consultant for Boston Scientific and compensation for teaching purposes and proctoring from Abbott and Boston Scientific. E.M.: speaker fees from EBR Systems. G.C.: consultant for Boston Scientific. G.D.E.: fees for lectures and proctorship from Abbott, Biotronik, Boston Scientific, and Zoll. G.R.: speaker fees from Medtronic, Abbott, Biotronik, Boston Scientific, MicroPort, Biosense Webster, and EBR Systems. No other authors have conflicts of interest to disclose.

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