Abstract
Background
Cardiac implantable electronic device (CIED) infections have a high morbidity and mortality and are an indication of device extraction. As a replacement, leadless pacemakers (LPs) may be preferable due to a low infection risk, but mid-term data on reinfections is lacking. Moreover, early LP reimplantation in pacemaker-dependent patients would circumvent the need for temporary pacemakers.
Methods
We included all patients with LP implantation as a replacement for an infected CIED, between January 2013 and December 2021. The occurrence of reinfection was assessed during standard follow-up visits.
Results
Twenty-nine patients (mean age 81 ± 9 years) were included, of which 21 (73%) had a pocket infection, 7 (24%) endocarditis, and 1 (3%) a systemic infection without endocarditis. All LP implantations were successful. LPs were implanted before extraction (n = 4, 13%), simultaneously with extraction (n = 5, 17%) and after extraction (n = 20, 70%). No reinfection occurred during the follow-up of median 32 months (IQR 13–66 months). Repeat blood cultures obtained in 9 (30%) patients and transthoracic echocardiography in all 7 patients with pacemaker endocarditis were negative for reinfection. In a subset of 6 LPs extracted during follow-up due to early battery depletion, prophylactically after the battery advisory or due to non-capture (median 36 months (range 0–67 months) post-implantation), histopathologic examination of tissues around the LPs showed no signs of infection.
Conclusions
After replacing infected CIEDs for an LP, no reinfections occurred in over 2.5 years follow-up. These results confirm that in case of CIED infection, the LP is an appealing replacement device. LP implantation before CIED extraction is feasible.
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Data availability
The data underlying this article will be shared on reasonable request to the corresponding author.
References
Udo EO, Zuithoff NP, van Hemel NM, de Cock CC, Hendriks T, Doevendans PA, et al. Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study. Heart Rhythm. 2012;9(5):728–35.
Kirkfeldt RE, Johansen JB, Nohr EA, Jørgensen OD, Nielsen JC. Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark. Eur Heart J. 2014;35(18):1186–94.
Blomström-Lundqvist C, Traykov V, Erba PA, Burri H, Nielsen JC, Bongiorni MG, et al. European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections—endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), International Society for Cardiovascular Infectious Diseases (ISCVID) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). EP Europace. 2019;22(4):515–49.
Beurskens NEG, Breeman KTN, Dasselaar KJ, Meijer AC, Quast ABE, Tjong FVY, et al. Leadless cardiac pacing systems: current status and future prospects. Expert Rev Med Devices. 2019;16(11):923–30.
Koay A, Khelae S, Wei KK, Muhammad Z, Mohd Ali R, Omar R. Treating an infected transcatheter pacemaker system via percutaneous extraction. HeartRhythm Case Rep. 2016;2(4):360–2.
Okada A, Shoda M, Tabata H, Kobayashi H, Shoin W, Okano T, et al. Simultaneous infection of abandoned leads and newly implanted leadless cardiac pacemaker: why did this occur? J Cardiol Cases. 2021;23(1):35–7.
Ellison K, Hesselson A, Ayoub K, Leung S, Gurley J. Retrieval of an infected leadless pacemaker. HeartRhythm Case Rep. 2020;6(11):863–6.
El-Chami MF, Bockstedt L, Longacre C, Higuera L, Stromberg K, Crossley G, et al. Leadless vs. transvenous single-chamber ventricular pacing in the Micra CED study: 2-year follow-up. European Heart Journal. (2021).
Piccini JP, El-Chami M, Wherry K, Crossley GH, Kowal RC, Stromberg K, et al. Contemporaneous comparison of outcomes among patients implanted with a leadless vs transvenous single-chamber ventricular pacemaker. JAMA Cardiol. (2021).
El-Chami MF, Soejima K, Piccini JP, Reynolds D, Ritter P, Okabe T, et al. Incidence and outcomes of systemic infections in patients with leadless pacemakers: data from the Micra IDE study. Pacing Clin Electrophysiol. 2019;42(8):1105–10.
Breeman KTN, du Long R, Beurskens NEG, van der Wal AC, Wilde AAM, Tjong FVY, et al. Tissues attached to retrieved leadless pacemakers: histopathological evaluation of tissue composition in relation to implantation time and complications. Heart Rhythm. 2021;18(12):2101–9.
Beurskens NEG, Tjong FVY, Dasselaar KJ, Kuijt WJ, Wilde AAM, Knops RE. Leadless pacemaker implantation after explantation of infected conventional pacemaker systems: a viable solution? Heart Rhythm. 2019;16(1):66–71.
El-Chami MF, Johansen JB, Zaidi A, Faerestrand S, Reynolds D, Garcia-Seara J, et al. Leadless pacemaker implant in patients with pre-existing infections: results from the Micra postapproval registry. J Cardiovasc Electrophysiol. 2019;30(4):569–74.
Bicong L, Allen JC, Arps K, Al-Khatib SM, Bahnson TD, Daubert JP, et al. Leadless pacemaker implantation after lead extraction for cardiac implanted electronic device infection. J Cardiovasc Electrophysiol. (2022).
Tjong FVY, de Ruijter UW, Beurskens NEG, Knops RE. A comprehensive scoping review on transvenous temporary pacing therapy. Neth Heart J. 2019;27(10):462–73.
Boriani G, Lane DA, Windecker S, Huber K, Kirchhof P, Lip GY. Difficult decision making in the management of patients with atrial fibrillation and acute coronary syndrome or invasive cardiovascular interventions: new recommendations for daily practice. Europace. 2015;17(9):1319–22.
El-Chami MF, Johansen JB, Zaidi A, Faerestrand S, Reynolds D, Garcia-Seara J, et al. Leadless pacemaker implant in patients with pre-existing infections: results from the Micra postapproval registry. J Cardiovasc Electrophysiol. 2019;30(4):569–74.
Chang D, Gabriels JK, Soo Kim B, Ismail H, Willner J, Beldner SJ, et al. Concomitant leadless pacemaker implantation and lead extraction during an active infection. J Cardiovasc Electrophysiol. 2020;31(4):860–7.
Birnie DH, Wang J, Alings M, Philippon F, Parkash R, Manlucu J, et al. Risk factors for infections involving cardiac implanted electronic devices. J Am Coll Cardiol. 2019;74(23):2845–54.
Boyle TA, Uslan DZ, Prutkin JM, Greenspon AJ, Baddour LM, Danik SB, et al. Reimplantation and repeat infection after cardiac-implantable electronic device infections: experience from the MEDIC (Multicenter Electrophysiologic Device Infection Cohort) database. Circ Arrhythm Electrophysiol. (2017);10(3).
Chew D, Somayaji R, Conly J, Exner D, Rennert-May E. Timing of device reimplantation and reinfection rates following cardiac implantable electronic device infection: a systematic review and meta-analysis. BMJ Open. 2019;9(9):e029537.
St. Jude Medical I. Important medical device advisory: battery malfunction for nanostim leadless cardiac pacemaker (LCP). Model Number S1DLCP [Available from: https://www.cardiovascular.abbott/content/dam/bss/divisionalsites/cv/pdf/reports/BatteryMalfunction-NanostimLCP-Doctor-Letter-28Oct2016.pdf.
Mountantonakis SE, Tschabrunn CM, Deyell MW, Cooper JM. Same-day contralateral implantation of a permanent device after lead extraction for isolated pocket infection. Europace. 2014;16(2):252–7.
Nandyala R, Parsonnet V. One stage side-to-side replacement of infected pulse generators and leads. Pacing Clin Electrophysiol. 2006;29(4):393–6.
Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, et al. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021;42(35):3427–520.
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This study was approved by the Medical Ethical Committee of our hospital.
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RK reports consultancy fees and research grants from Abbott, Boston Scientific, Medtronic, and Cairdac and has stock options from AtaCor Medical Inc. FT received consulting honoraria from Abbott and Boston Scientific. The other authors did not have conflicts of interest.
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What’s new?
• Leadless pacemakers (LPs) carry a very low infection risk and are therefore an appealing option in case of pacemaker infection. However, mid-term data on the recurrence of infections is lacking. Also, infected devices are usually replaced after extraction, but recent studies suggest that LPs can be safely implanted simultaneously to circumvent the use of temporary pacemakers and decrease hospitalization duration.
• In this study, LP implantations after, simultaneously with and even up to 4 days before extraction are reported. No reinfections were seen during more than 2.5 years follow-up.
• These results confirm that LPs are an attractive replacement option for infected pacemakers and suggest that LP implantation before extraction is feasible.
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Breeman, K.T.N., Beurskens, N.E.G., Driessen, A.H.G. et al. Timing and mid-term outcomes of using leadless pacemakers as replacement for infected cardiac implantable electronic devices. J Interv Card Electrophysiol 66, 1477–1485 (2023). https://doi.org/10.1007/s10840-022-01457-w
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DOI: https://doi.org/10.1007/s10840-022-01457-w