First long-term outcome data for the MicraVR™ transcatheter pacing system: data from the largest prospective German cohort.
Complications
Indications
Leadless pacer
Long-term follow-up
Outside registry experience
Journal
Clinical research in cardiology : official journal of the German Cardiac Society
ISSN: 1861-0692
Titre abrégé: Clin Res Cardiol
Pays: Germany
ID NLM: 101264123
Informations de publication
Date de publication:
22 Aug 2023
22 Aug 2023
Historique:
received:
28
03
2023
accepted:
10
08
2023
medline:
22
8
2023
pubmed:
22
8
2023
entrez:
22
8
2023
Statut:
aheadofprint
Résumé
The MicraVR™ transcatheter pacing system (TPS) has been implemented into clinical routine for several years. The primary recipients are patients in need for VVI pacing due to bradycardia in the setting of atrial fibrillation (AF). Implantation safety and acute success have been proven in controlled studies and registries. So far only few long-term real-life data on TPS exist. We report indication, procedure and outcome data from two high-volume implanting German centers. Between 2016 and 2019, 188 (of 303) patients were included. During follow-up (FU), TPS interrogation was performed after 4 weeks and thereafter every 6 months. Indication for TPS implantation in 159/188 (85%) patients was permanent or intermittent AV block III° in the setting of atrial fibrillation. The mean procedure duration was 50 min [35.0-70.0]. The average acute values after system release were: thresholds: 0.5V [0.38-0.74]/0.24ms; R-wave sensing: 10.0mV [8.1-13.5]; impedance: 650 Ohm [550-783]; RV-pacing demand: 16.9% [0.9-75.9]; and battery status: 3.15 V [3.12-3.16]. During FU of 723.4 ± 597.9 days, neither pacemaker failure nor infections were reported. Long-term FU revealed: thresholds: 0.5V [0.38-0.63]/0.24 ms; sensing: 12.3mV [8.9-17.2]; impedance: 570 Ohm [488-633]; RV-pacing demand: 87.1% [29.5-98.6]; and battery status 3.02 V [3.0-3.1]. Forty-three patients died from not-device-related causes. This to date largest German long-term dataset for MicraVR™ TPS implantation revealed stable device parameter. Foremost, battery longevity seems to fulfill predicted values despite a significant increase in RV-pacing demand over time and even in patients with consecutive AV-node ablation. Of note, no infections or system failure were observed.
Identifiants
pubmed: 37606854
doi: 10.1007/s00392-023-02286-1
pii: 10.1007/s00392-023-02286-1
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2023. The Author(s).
Références
Kirkfeldt RE, Johansen JB, Nohr EA, Jørgensen OD, Nielsen JC (2014) Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark. Eur Heart J 35:1186–1194
doi: 10.1093/eurheartj/eht511
pubmed: 24347317
Udo EO, Zuithoff NPA, van Hemel NM, de Cock CC, Hendriks T, Doevendans PA et al (2012) Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study. Heart Rhythm 9:728–735
doi: 10.1016/j.hrthm.2011.12.014
pubmed: 22182495
Reynolds D, Duray GZ, Omar R, Soejima K, Neuzil P, Zhang S et al (2016) A leadless intracardiac transcatheter pacing system. N Engl J Med 374:533–541
doi: 10.1056/NEJMoa1511643
pubmed: 26551877
Duray GZ, Ritter P, El-Chami M, Narasimhan C, Omar R, Tolosana JM et al (2017) Micra Transcatheter Pacing Study Group. Long-term performance of a transcatheter pacing system: 12-Month results from the Micra Transcatheter Pacing Study. Heart Rhythm 14(5):702–709
doi: 10.1016/j.hrthm.2017.01.035
pubmed: 28192207
Roberts PR, Clementy N, Al Samadi F, Garweg C, Martinez-Sande JL, Iacopino S et al (2017) A leadless pacemaker in the real-world setting: The Micra Transcatheter Pacing System Post-Approval Registry. Heart Rhythm 14:1375–1379
doi: 10.1016/j.hrthm.2017.05.017
pubmed: 28502871
Zucchelli G, Barletta V, Tommasina VD, Viani S, Parollo M, Mazzocchetti L et al (2019) Micra pacemaker implant after cardiac implantable electronic device extraction: feasibility and long-term outcomes. Europace 21:1229–1236
doi: 10.1093/europace/euz160
pubmed: 31180481
Tolosana JM, Guasch E, San Antonio R, Apolo J, Pujol-López M, Chipa-Ccasani F et al (2020) Very high pacing thresholds during long-term follow-up predicted by a combination of implant pacing threshold and impedance in leadless transcatheter pacemakers. J Cardiovasc Electrophysiol 31:868–874
doi: 10.1111/jce.14360
pubmed: 31967367
https://www.medtronic.com/de-de/fachkreise/produkte/rhythmologie-elektrophysiologie/herzschrittmacher/micra-stimulationssysteme.html . Accessed 02 Nov 2022
Glikson M, Nielson JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM et al (2021) 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J 00:1–94
Ritter P, Duray GZ, Zhang S, Narasimhan C, Soejima K, Omar R et al (2015) The rationale and design of the Micra Transcatheter Pacing Study: safety and efficacy of a novel miniaturized pacemaker. Europace 17:807–813
doi: 10.1093/europace/euv026
pubmed: 25855677
Wörmann J, Lüker J, Plenge T, van den Bruck JH, Steven D, Sultan A (2020) First transcatheter leadless pacemaker implantation in a pediatric patient with a genetic disease. Herzschr Elektrophys 31:235–237
doi: 10.1007/s00399-020-00685-9
Kuffer L, Steven D, van den Bruck JH, Plenge T, Lüker J, Doerner J et al (2019) Functional parameters impairment after MRI in a patient with a transcatheter pacing system. J Magn Reson Imaging 50:334–335
doi: 10.1002/jmri.26588
pubmed: 30648310
Saad TF, Weiner HL (2017) Venous hemodialysis catheters and cardiac implantable electronic devices: avoiding a high-risk combination. Semin Dial 30:187–192
doi: 10.1111/sdi.12581
pubmed: 28229483
Yevzlin A, Asif A (2009) Stent placement in hemodialysis access: historical lessons, the state of the art and future directions. Clin J Am Soc Nephrol 4:996–1008
doi: 10.2215/CJN.04040808
pubmed: 19406965
Saad TF (2001) Central venous dialysis catheters: catheter-associated infection. Semin Dial 14:446–451
doi: 10.1046/j.1525-139x.2001.00110.x
pubmed: 11851931
Kirkfeldt RE, Johansen JB, Nielsen JC (2016) Management of cardiac electronic device infections: challenges and outcomes. Arrhythm Electrophysiol Rev 5:183–187
doi: 10.15420/aer.2016:21:2
pubmed: 28116083
pmcid: 5248667
Cantillon DJ, Exner DV, Badie N, Davis K, Yan GN, Nabutovsky Y et al (2017) Complications and health care costs associated with transvenous cardiac pacemakers in a nationwide assessment. JACC Clin Electrophysiol 3:1296–1305
doi: 10.1016/j.jacep.2017.05.007
pubmed: 29759627