Abstract: Introduction: Permanent pacing indications are common after cardiac surgery and transcatheter structural valve interventions. Leadless pacemakers (LPs) have emerged as a useful alternative to transvenous pacemakers. However, current commercially available LPs are unable to provide atrial pacing or cardiac resynchronization and relatively little is known about LP outcomes after cardiac surgery and transcatheter valve interventions.
Methods: This retrospective study included patients who received a Micra VR (Micra TM MC1VR01) or Micra AV (Micra TM MC1AVR1) (Medtronic) leadless pacemaker following cardiac surgery or transcatheter structural valve intervention between September 2014 and September 2022. Device performance and clinical outcomes, including ventricular pacing burden, ejection fraction, and need for conversion to transvenous pacing systems, were evaluated during follow-up.
Results: A total of 78 patients were included, of whom 40 received a Micra VR LP implant, and 38 received a Micra AV LP implant. The mean age of the cohort was 65.9 ± 17.9 years, and 48.1% were females. The follow-up duration for the entire cohort was 1.3 ± 1.1 years: 1.6 ± 1.3 years for the Micra VR group and 0.8 ± 0.5 years for the Micra AV group. Among the cohort, 50 patients had undergone cardiac surgery and 28 underwent transcatheter structural valve interventions. Device electrical performance was excellent during follow-up, with a small but clinically insignificant increase in ventricular pacing threshold and a slight decrease in pacing impedance. The mean right ventricle pacing (RVP) burden significantly decreased over time in the entire cohort (74.3% ± 37.2% postprocedure vs. 47.7% ± 40.6% at last follow-up, p < .001), and left ventricle ejection fraction (LVEF) showed a modest but significant downward trend during follow-up (55.0% ± 10.6% vs. 51.5% ± 11.2% p < .001). Patients with Micra VR implants had significantly reduced LVEF during follow-up (54.1% ± 11.9% vs. 48.8% ± 11.9%, p = .003), whereas LVEF appeared stable in the Micra AV group during follow-up (56.1% ± 9.0% vs. 54.6% ± 9.7%, p = .06). Six patients (7.7%) required conversion to transvenous pacing systems, four who required cardiac resynchronization for drop in LVEF with high RVP burden and two who required dual-chamber pacemakers for symptomatic sinus node dysfunction.
Conclusion: Leadless pacemakers provide a useful alternative to transvenous pacemakers in appropriately selected patients after cardiac surgery and transcatheter structural valve interventions. Device performance is excellent over medium-term follow-up. However, a significant minority of patients require conversion to transvenous pacing systems for cardiac resynchronization or atrial pacing support, demonstrating the need for close electrophysiologic follow-up in this cohort.
(© 2023 Wiley Periodicals LLC.)
References: Kim MH, Deeb GM, Eagle KA, et al. Complete atrioventricular block after valvular heart surgery and the timing of pacemaker implantation. Am J Cardiol. 2001;87:649-651.
Sammour Y, Krishnaswamy A, Kumar A, et al. Incidence, predictors, and implications of permanent pacemaker requirement after transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2021;14:115-134.
Reddy VY, Knops RE, Sperzel J, et al. Permanent leadless cardiac pacing: results of the LEADLESS trial. Circulation. 2014;129:1466-1471.
Udo EO, Zuithoff NPA, van Hemel NM, et al. Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study. Heart Rhythm. 2012;9:728-735.
Knops RE, Tjong FVY, Neuzil P, et al. Chronic performance of a leadless cardiac pacemaker. JACC. 2015;65:1497-1504.
Reynolds D, Duray GZ, Omar R, et al. A leadless intracardiac transcatheter pacing system. N Engl J Med. 2016;374:533-541.
El-Chami MF, Bockstedt L, Longacre C, et al. Leadless vs. transvenous single-chamber ventricular pacing in the Micra CED study: 2-year follow-up. Eur Heart J. 2022;43:1207-1215.
Chinitz L, Ritter P, Khelae SK, et al. Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker: results from the Micra atrioventricular feasibility studies. Heart Rhythm. 2018;15:1363-1371.
El-Chami MF, Roberts PR, Kypta A, et al. How to implant a leadless pacemaker with a tine-based fixation. J Cardiovasc Electrophysiol. 2016;27:1495-1501.
El-Chami MF, Al-Samadi F, Clementy N, et al. Updated performance of the Micra transcatheter pacemaker in the real-world setting: a comparison to the investigational study and a transvenous historical control. Heart Rhythm. 2018;15:1800-1807.
Piccini JP, El-Chami M, Wherry K, et al. Contemporaneous comparison of outcomes among patients implanted with a leadless vs transvenous single-chamber ventricular pacemaker. JAMA Cardiol. 2021;6:1187-1195.
Crossley GH, Piccini JP, Longacre C, Higuera L, Stromberg K, El-Chami MF. Leadless versus transvenous single-chamber ventricular pacemakers: 3 year follow-up of the Micra CED study. J Cardiovasc Electrophysiol. 2023;34:1015-1023.
Moore SKL, Chau KH, Chaudhary S, et al. Leadless pacemaker implantation: a feasible and reasonable option in transcatheter heart valve replacement patients. Pacing Clin Electrophysiol. 2019;42:542-547.
Haeberlin A, Bartkowiak J, Brugger N, et al. Evolution of tricuspid valve regurgitation after implantation of a leadless pacemaker: a single center experience, systematic review, and meta-analysis. J Cardiovasc Electrophysiol. 2022;33:1617-1627.
Beurskens NEG, Tjong FVY, de Bruin-Bon RHA, et al. Impact of leadless pacemaker therapy on cardiac and atrioventricular valve function through 12 months of follow-up. Circ Arrhythm Electrophysiol. 2019;12:e007124.
Garweg C, Vandenberk B, Foulon S, et al. Leadless pacemaker for patients following cardiac valve intervention. Arch Cardiovasc Dis. 2020;113:772-779.
Roberts PR, Clémenty N, Mondoly P, et al. A leadless pacemaker in the real-world setting: patient profile and performance over time. J Arrhythm. 2023;39:1-9.
Reddy VY, Exner DV, Doshi R, et al. 1-year outcomes of a leadless ventricular pacemaker: the LEADLESS II (phase 2) trial. JACC Clin Electrophysiol. 2023;9:1187-1189.
Beccarino NJ, Choi EY, Liu B, et al. Concomitant leadless pacing in pacemaker-dependent patients undergoing transvenous lead extraction for active infection: mid-term follow-up. Heart Rhythm. 2023;20:853-860.
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