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 MD , Giovanni Rovaris MD , Domenico Giovanni Della Rocca MD, PhD , Paolo Della Bella MD, PhD , Ennio Carmine Luigi Pisanò MD , Lorenzo Mazzocchetti MD , Zefferino Palamà MD , Gabriele Dell’Era MD , Antonio Strangio MD , Antonio Dello Russo MD, PhD , Vincenzo Paolo Caccavo MD , Antonio Curcio MD, PhD , Cosimo Mandurino MD , Giorgio Spiniello MD , Domenico Gianfrancesco MD , Giovanni Caroli MD , Massimo Grimaldi MD , Giovanni Volpato MD , Fabio Megna MD , Giuseppe Patti MD, PhD , Antonino Nicosia MD
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引用次数: 0
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.
期刊介绍:
HeartRhythm, the official Journal of the Heart Rhythm Society and the Cardiac Electrophysiology Society, is a unique journal for fundamental discovery and clinical applicability.
HeartRhythm integrates the entire cardiac electrophysiology (EP) community from basic and clinical academic researchers, private practitioners, engineers, allied professionals, industry, and trainees, all of whom are vital and interdependent members of our EP community.
The Heart Rhythm Society is the international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education, and optimal health care policies and standards.