Evolution of ventricular and valve function in patients with right ventricular pacing - A randomized controlled trial comparing leadless and conventional pacing.
leadless pacing
micra transcatheter pacemaker
valve function
ventricular function
Journal
Pacing and clinical electrophysiology : PACE
ISSN: 1540-8159
Titre abrégé: Pacing Clin Electrophysiol
Pays: United States
ID NLM: 7803944
Informations de publication
Date de publication:
12 2023
12 2023
Historique:
revised:
25
10
2023
received:
07
09
2023
accepted:
29
10
2023
medline:
17
12
2023
pubmed:
14
11
2023
entrez:
14
11
2023
Statut:
ppublish
Résumé
Leadless pacemakers (PMs) were recently introduced to overcome lead-related complications. They showed high safety and efficacy profiles. Prospective studies assessing long-term safety on cardiac structures are still missing. The purpose of this study was to compare the mechanical impact of Micra with conventional PM on heart function. We conducted a non-inferiority trial in patients with an indication for single chamber ventricular pacing. Patients were 1:1 randomized to undergo implantation of either Micra or conventional monochamber ventricular pacemaker (PM). Patients underwent echocardiography at baseline, 6 and 12 months after implantation. Analysis included left ventricular ejection fraction (LVEF), global longitudinal strain (GLS) and valve function. N-terminal-pro hormone B-type natriuretic peptide (NT-pro-BNP) levels were measured at baseline and 12 months. Fifty-one patients (27 in Micra group and 24 in conventional group) were included. Baseline characteristics were similar for both groups. At 12 months, (1) the left ventricular function as assessed by LVEF and GLS worsened similarly in both groups (∆LVEF -10 ± 7.3% and ∆GLS +5.7 ± 6.4 in Micra group vs. -13.4 ± 9.9% and +5.2 ± 3.2 in conventional group) (p = 0.218 and 0.778, respectively), (2) the severity of tricuspid valve regurgitation was significantly lower with Micra than conventional pacing (p = 0.009) and (3) median NT-pro-BNP was lower in Micra group (970 pg/dL in Micra group versus 1394 pg/dL in conventional group, p = 0.041). Micra is non inferior to conventional PMs concerning the evolution of left ventricular function at 12-month follow-up. Our data suggest that Micra has a comparable mechanical impact on the ventricular systolic function but resulted in less valvular dysfunction.
Sections du résumé
BACKGROUND
Leadless pacemakers (PMs) were recently introduced to overcome lead-related complications. They showed high safety and efficacy profiles. Prospective studies assessing long-term safety on cardiac structures are still missing.
OBJECTIVE
The purpose of this study was to compare the mechanical impact of Micra with conventional PM on heart function.
METHODS
We conducted a non-inferiority trial in patients with an indication for single chamber ventricular pacing. Patients were 1:1 randomized to undergo implantation of either Micra or conventional monochamber ventricular pacemaker (PM). Patients underwent echocardiography at baseline, 6 and 12 months after implantation. Analysis included left ventricular ejection fraction (LVEF), global longitudinal strain (GLS) and valve function. N-terminal-pro hormone B-type natriuretic peptide (NT-pro-BNP) levels were measured at baseline and 12 months.
RESULTS
Fifty-one patients (27 in Micra group and 24 in conventional group) were included. Baseline characteristics were similar for both groups. At 12 months, (1) the left ventricular function as assessed by LVEF and GLS worsened similarly in both groups (∆LVEF -10 ± 7.3% and ∆GLS +5.7 ± 6.4 in Micra group vs. -13.4 ± 9.9% and +5.2 ± 3.2 in conventional group) (p = 0.218 and 0.778, respectively), (2) the severity of tricuspid valve regurgitation was significantly lower with Micra than conventional pacing (p = 0.009) and (3) median NT-pro-BNP was lower in Micra group (970 pg/dL in Micra group versus 1394 pg/dL in conventional group, p = 0.041).
CONCLUSION
Micra is non inferior to conventional PMs concerning the evolution of left ventricular function at 12-month follow-up. Our data suggest that Micra has a comparable mechanical impact on the ventricular systolic function but resulted in less valvular dysfunction.
Banques de données
ClinicalTrials.gov
['NCT06100757']
Types de publication
Equivalence Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1455-1464Informations de copyright
© 2023 Wiley Periodicals LLC.
Références
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