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. 2021 Aug;61(2):395-404.
doi: 10.1007/s10840-020-00832-9. Epub 2020 Jul 25.

Comparison between leadless and transvenous single-chamber pacemaker therapy in a referral centre for lead extraction

Giulio Zucchelli  1 , Silvio Tolve  1 , Valentina Barletta  2 , Andrea Di Cori  1 , Matteo Parollo  1 , Raffaele De Lucia  1 , Veronica Della Tommasina  1 , Mario Giannotti Santoro  1 , Stefano Viani  1 , Tea Cellamaro  1 , Luca Segreti  1 , Luca Paperini  1 , Ezio Soldati  1 , Maria Grazia Bongiorni  1
Affiliations

Comparison between leadless and transvenous single-chamber pacemaker therapy in a referral centre for lead extraction

Giulio Zucchelli et al. J Interv Card Electrophysiol. 2021 Aug.

Abstract

Purpose: The aim of the study was to compare the long-term clinical and electrical performance of Micra leadless pacemaker with transvenous single-chamber pacemaker (TV-VVI PM) in a high-volume centre for transvenous lead extraction (TLE).

Methods: One-hundred patients (group 1) undergoing Micra implant were matched with 100 patients undergoing TV-VVI PM implant (group 2) by age, sex, left ventricular systolic ejection fraction and previous TLE.

Results: The implant procedure was successful in all patients. In group 1, the procedure duration was lower than in group 2 (43.86 ± 22.38 vs 58.38 ± 17.85 min, p < 0.001), while the fluoroscopy time was longer (12.25 ± 6.84 vs 5.32 ± 4.42 min, p < 0.001). There was no difference about the rate of septal implant at the right ventricle (76% vs 86%, p = 0.10). Patients were followed-up for a median of 12 months. No acute and chronic procedure-related complication was observed in group 1, while we reported acute complications in seven patients (7%, p = 0.02) and long-term complications in three patients (3%, p = 0.24), needing for a system revision in 6 cases (6%, p = 0.038), in group 2. One systemic infection occurred in TV-VVI PM group. Electrical measurements were stable during follow-up in both groups, with a longer estimated battery life in group 1 (mean delivered energy at threshold at discharge: 0.14 ± 0.21 vs 0.26 ± 0.22 μJ, p < 0.001).

Conclusion: Micra pacemaker implant is a safe and effective procedure, with a lower rate of acute complications and system revisions compared with TV-VVI PM, even in a real-life setting including patients who underwent TLE.

Keywords: Leadless pacemaker; Micra pacemaker; Pacemaker complication; Transvenous lead extraction; Transvenous pacemaker.

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