Leadless pacemakers at 5-year follow-up : the Micra transcatheter pacing system post-approval registry
El-Chami, Mikhael F. (Emory University)
Garweg, Christophe (UZ Leuven)
Clementy, Nicolas (Centre Hospitalier Régional Universitaire de Tours - Hôpital Trousseau)
Al-Samadi, Faisal (King Salman Heart Center-King Fahad Medical City)
Iacopino, Saverio (University of Milan)
Martinez-Sande, Jose Luis (University Clinical Hospital of Santiago de Compostela)
Roberts, Paul R. (University Hospital Southampton NHS Foundation Trust (Regne Unit))
Tondo, Claudio (University of Milan)
Johansen, Jens Brock (Odense University Hospital (Dinamarca))
Viñolas, Xavier (Institut de Recerca Sant Pau)
Cha, Yong-Mei (Mayo Clinic (Rochester, Estats Units d'Amèrica))
Grubman, Eric (Yale University School of Medicine)
Bordachar, Pierre (Bordeaux University Hospital (França))
Stromberg, Kurt (Medtronic. Inc.)
Fagan, Dedra H. (Medtronic. Inc.)
Piccini, Jonathan P. (Duke University Medical Center)
Universitat Autònoma de Barcelona

Date:	2024
Abstract:	Prior reports have demonstrated a favourable safety and efficacy profile of the Micra leadless pacemaker over mid-term Aims follow-up; however, long-term outcomes in real-world clinical practice remain unknown. Updated performance of the Micra VR leadless pacemaker through five years from the worldwide post-approval registry (PAR) was assessed. All Micra PAR patients undergoing implant attempts were included. Endpoints included system- or procedure-related major complications and system revision rate for any cause through 60 months post-implant. Rates were compared through 36 months post-implant to a reference dataset of 2667 transvenous pacemaker patients using Fine-Gray competing risk models. 1809 patients were enrolled between July 2015 and March 2018 and underwent implant attempts from 179 centres in 23 countries with a median follow-up period of 51. 1 months (IQR: 21. 6-64. 2). The major complication rate at 60 months was 4. 5% [95% confidence interval (CI): 3. 6%-5. 5%] and was 4. 1% at 36 months, which was significantly lower than the 8. 5% rate observed for transvenous systems (HR:. 47, 95% CI:. 36-. 61; P <. 001). The all-cause system revision rate at 60 months was 4. 9% (95% CI: 3. 9%-6. 1%). System revisions among Micra patients were mostly for device upgrades (41. 2%) or elevated thresholds (30. 6%). There were no Micra removals due to infection noted over the duration of follow-up. At 36 months, the system revision rate was significantly lower with Micra vs. transvenous systems (3. 2% vs. 6. 6%, P <. 001). Long-term outcomes with the Micra leadless pacemaker continue to demonstrate low rates of major complications and system revisions and an extremely low incidence of infection.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Bradycardia ; Clinical trial ; Leadless pacing ; Long-term outcomes ; Pacemaker
Published in:	European heart journal, Vol. 45 Núm. 14 (july 2024) , p. 1241-1251, ISSN 1522-9645

DOI: 10.1093/eurheartj/ehae101
PMID: 38426911

11 p, 723.8 KB

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