Utilizing Leadless Pacemakers in Extremely Elderly Patients With a Conventional Pacemaker System: A Two-Year Follow-Up Case Series Without Generator Extraction in High-Risk Scenarios

Overview

Journal Cureus

Specialty Biomedical Engineering

Date 2024 Sep 17

PMID 39286713

Authors

Man Fong Chu

Weng Chio Tam

Kuok Wun Lam

Chon Hou Chan

Mario Evora

U Po Lam

Affiliations

Soon will be listed here.

Abstract

Background and objectives Leadless pacemakers, known for their safer clinical profile, offer significant advantages for elderly patients at a higher risk of complications associated with transvenous pacemaker procedures, particularly those susceptible to high-risk bleeding and infections related to cardiac implantable electronic device interventions. This study explores an alternative use of leadless pacemakers without removing existing transvenous systems, deviating from conventional generator replacement and lead re-interventions. Methods This study was conducted with full approval from the Institutional Review Board, Medical Ethical Committee, Centro Hospitalar Conde São Januário, Macau. Between January 2018 and December 2021, we conducted a retrospective case series involving extremely elderly individuals (aged 85 years or older) at a high risk of complications, necessitating either generator replacement or lead re-implantation. The study considered implanting a leadless pacemaker (Micra; Medtronic, Minneapolis, MN, USA) without removing the transvenous generator. For the primary endpoints, we evaluated procedure-related complications and clinical outcomes during hospitalization. Secondary endpoints included the stability of parameters and any unexpected interference or interactions between the two systems during the two-year follow-up. Results Eleven patients (aged 86-101) were enrolled, most receiving antiplatelet or anticoagulation therapy. Leadless pacemaker implantation proceeded without major complications or adverse clinical outcomes during hospitalization. Regular follow-up was conducted every three to six months for adjusting pacemaker parameters and interrogating each patient. Over two years, three patients died from non-cardiac causes: two from infection and one from spontaneous intracranial hemorrhage, while eight completed regular follow-ups. We didn't detect any episodes of ventricular arrhythmias or intracardiac capture from the transvenous pacemaker system. We observed the stability in both the longevity and the voltage of the conventional generator battery, maintaining similar parameters without significant depletion (mean voltage decline: -0.07V/year). Parameters of the leadless pacemaker remained consistently normal without interference with existing pacing systems. Conclusion Implanting leadless pacemakers without removing transvenous pacemaker generators appears safe and effective for extremely elderly patients who are at high risk of complications. Comprehensive two-year follow-up supports the safety and viability of this approach. Opting for this approach instead of conventional generator replacement, with or without additional lead implantation, may be reasonable in this population. However, further research within this patient cohort, such as exploring long-term outcomes beyond two years or comparing clinical outcomes with conventional strategies, may be necessary.

References

Han H, Hawkins N, Pearman C, Birnie D, Krahn A . Epidemiology of cardiac implantable electronic device infections: incidence and risk factors. Europace. 2021; 23(23 Suppl 4):iv3-iv10. PMC: 8221051. DOI: 10.1093/europace/euab042. View

Drozdz G, Hrymniak B, Biel B, Skoczynski P, Drozdz W, Zysko D . Implantation of a Leadless Pacemaker after Incomplete Transvenous Lead Extraction in a 90-Year-Old Pacemaker-Dependent Patient. Int J Environ Res Public Health. 2022; 19(10). PMC: 9141955. DOI: 10.3390/ijerph19106313. View

Birnie D, Wang J, Alings M, Philippon F, Parkash R, Manlucu J . Risk Factors for Infections Involving Cardiac Implanted Electronic Devices. J Am Coll Cardiol. 2019; 74(23):2845-2854. DOI: 10.1016/j.jacc.2019.09.060. View

Prutkin J, Reynolds M, Bao H, Curtis J, Al-Khatib S, Aggarwal S . Rates of and factors associated with infection in 200 909 Medicare implantable cardioverter-defibrillator implants: results from the National Cardiovascular Data Registry. Circulation. 2014; 130(13):1037-43. DOI: 10.1161/CIRCULATIONAHA.114.009081. View

Virani S, Newby L, Arnold S, Bittner V, Brewer L, Demeter S . 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2023; 82(9):833-955. DOI: 10.1016/j.jacc.2023.04.003. View

Moltrasio M, Sicuso R, Tundo F, Tondo C . A new leadless pacemaker with atrioventricular synchronous pacing replacing a still working VVI leadless pacemaker: a case report. Eur Heart J Case Rep. 2021; 5(8):ytab305. PMC: 8364773. DOI: 10.1093/ehjcr/ytab305. View

Sideris S, Archontakis S, Dilaveris P, Gatzoulis K, Trachanas K, Sotiropoulos I . Leadless Cardiac Pacemakers: Current status of a modern approach in pacing. Hellenic J Cardiol. 2017; 58(6):403-410. DOI: 10.1016/j.hjc.2017.05.004. View

Marschall A, Del Castillo Carnevali H, Torres Lopez M, Goncalves Sanchez F, Dejuan Bitria C, Rubio Alonso M . Leadless pacemaker for urgent permanent implantation in elderly and very elderly patients. J Cardiovasc Med (Hagerstown). 2021; 23(1):e27-e29. DOI: 10.2459/JCM.0000000000001257. View

Omdahl P, Eggen M, Bonner M, Iaizzo P, Wika K . Right Ventricular Anatomy Can Accommodate Multiple Micra Transcatheter Pacemakers. Pacing Clin Electrophysiol. 2015; 39(4):393-7. PMC: 4834726. DOI: 10.1111/pace.12804. View

10.

Kipp R, Hsu J, Freeman J, Curtis J, Bao H, Hoffmayer K . Long-term morbidity and mortality after implantable cardioverter-defibrillator implantation with procedural complication: A report from the National Cardiovascular Data Registry. Heart Rhythm. 2017; 15(6):847-854. DOI: 10.1016/j.hrthm.2017.09.043. View

11.

Steinwender C, Khelae S, Garweg C, Chan J, Ritter P, Johansen J . Atrioventricular Synchronous Pacing Using a Leadless Ventricular Pacemaker: Results From the MARVEL 2 Study. JACC Clin Electrophysiol. 2019; 6(1):94-106. DOI: 10.1016/j.jacep.2019.10.017. View

12.

Blomstrom-Lundqvist C, Traykov V, Erba P, Burri H, Nielsen J, Bongiorni M . 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.... Eur J Cardiothorac Surg. 2019; 57(1):e1-e31. DOI: 10.1093/ejcts/ezz296. View

13.

Piccini J, Cunnane R, Steffel J, El-Chami M, Reynolds D, Roberts P . Development and validation of a risk score for predicting pericardial effusion in patients undergoing leadless pacemaker implantation: experience with the Micra transcatheter pacemaker. Europace. 2022; 24(7):1119-1126. PMC: 9301971. DOI: 10.1093/europace/euab315. View

14.

Gelves-Meza J, Lang R, Valderrama-Achury M, Zamorano J, Vargas-Acevedo C, Medina H . Tricuspid Regurgitation Related to Cardiac Implantable Electronic Devices: An Integrative Review. J Am Soc Echocardiogr. 2022; 35(11):1107-1122. DOI: 10.1016/j.echo.2022.08.004. View

15.

Poole J, Gleva M, Mela T, Chung M, Uslan D, Borge R . Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation. 2010; 122(16):1553-61. DOI: 10.1161/CIRCULATIONAHA.110.976076. View

16.

Tatum R, Maynes E, Wood C, Deb A, Austin M, OMalley T . Tricuspid regurgitation associated with implantable electrical device insertion: A systematic review and meta-analysis. Pacing Clin Electrophysiol. 2021; 44(8):1297-1302. DOI: 10.1111/pace.14287. View

17.

Habboush S, Elmoursi A, Gadelmawla A, Masoud A, Khalil M, Sheashaa H . Transvenous Compared With Leadless Pacemakers: A meta-analysis comparing TP versus LP. Cardiol Rev. 2024; . DOI: 10.1097/CRD.0000000000000660. View

18.

Cantillon D, Dukkipati S, Ip J, Exner D, Niazi I, Banker R . Comparative study of acute and mid-term complications with leadless and transvenous cardiac pacemakers. Heart Rhythm. 2018; 15(7):1023-1030. DOI: 10.1016/j.hrthm.2018.04.022. View

19.

Okamura H . Lead extraction using a laser system: Techniques, efficacy, and limitations. J Arrhythm. 2016; 32(4):279-82. PMC: 4996850. DOI: 10.1016/j.joa.2015.06.006. View

20.

Middour T, Chen J, El-Chami M . Leadless pacemakers: A review of current data and future directions. Prog Cardiovasc Dis. 2021; 66:61-69. DOI: 10.1016/j.pcad.2021.06.003. View