TY - JOUR
T1 - Comparison of 30-day complications between a tine-based and a screw-in helix fixation single-chamber ventricular leadless pacemaker
T2 - Results of a propensity score–matched analysis from a multicenter, nationwide registry
AU - Palmisano, Pietro
AU - Rovaris, Giovanni
AU - Della Rocca, Domenico Giovanni
AU - Della Bella, Paolo
AU - Pisanò, Ennio Carmine Luigi
AU - Mazzocchetti, Lorenzo
AU - Palamà, Zefferino
AU - Dell'Era, Gabriele
AU - Strangio, Antonio
AU - Dello Russo, Antonio
AU - Caccavo, Vincenzo Paolo
AU - Curcio, Antonio
AU - Mandurino, Cosimo
AU - Spiniello, Giorgio
AU - Gianfrancesco, Domenico
AU - Caroli, Giovanni
AU - Grimaldi, Massimo
AU - Volpato, Giovanni
AU - Megna, Fabio
AU - Patti, Giuseppe
AU - Tricarico, Giuseppe
AU - Guarracini, Stefano
AU - Marino, Elena
AU - Alessandra, Marzi
AU - Giuseppe, D'Angelo A.
AU - Overeinder, Ingrid
AU - Montemerlo, Elisabetta
AU - Campisi, Giuseppe
AU - Coluccia, Giovanni
AU - Nicosia, Antonino
N1 - Publisher Copyright:
© 2025 Heart Rhythm Society
PY - 2025
Y1 - 2025
N2 - 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.
AB - 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.
KW - Aveir VR
KW - Cardiac perforation
KW - Complications
KW - Device migration
KW - Leadless pacemaker
KW - Micra VR
KW - Vascular complications
UR - http://www.scopus.com/inward/record.url?scp=105001374222&partnerID=8YFLogxK
U2 - 10.1016/j.hrthm.2025.03.1881
DO - 10.1016/j.hrthm.2025.03.1881
M3 - Article
SN - 1547-5271
JO - Heart Rhythm
JF - Heart Rhythm
ER -