Leadless Pacemakers: Recent and Future Developments
- 103 Downloads
Purpose of review
Leadless pacemakers were developed to reduce complications associated with transvenous pacemaker implant and long-term follow-up. Since initial market release, however, there have been registry and single-center reports documenting improvements in implant technique, reduced complication rates, and new patient populations studied.
Most studies have demonstrated a further reduction in complication rates and safe implant in those on continuous anticoagulation. Perforation rates are decreasing but still occur and risk factors include BMI < 20 kg/m2, age ≥ 85 years, females, history of heart failure, indication not including atrial fibrillation, and chronic lung disease. Device infections are exceedingly rare, even in those undergoing infected transvenous devices at the same time.
For appropriate patients, leadless pacing is a safe and reasonable option, especially if atrial-based sensing or pacing is not needed. Future iterations may include VDD pacing, atrial pacing, dual-chamber pacing, biventricular pacing, and device-device communication.
KeywordsLeadless pacemaker Pacemaker Complications Pacemaker implantation
Compliance with Ethical Standards
Conflict of Interest
The author declares that they have no conflict of interest.
Human and Animal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by any of the authors.
References and Recommended Reading
Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance
- 4.•• Reynolds D, Duray GZ, Omar R, Soejima K, Neuzil P, Zhang S, et al. A leadless intracardiac transcatheter pacing system. N Eng J Med. 2016;374(6):533–41 This is the study which led to FDA approval of the Micra pacemaker, describing the initial cohort, efficacy, and safety.Google Scholar
- 8.Kusumoto FM, Schoenfeld MH, Barrett C, Edgerton JR, Ellenbogen KA, Gold MR, et al. 2018 ACC/AHA/HRS guideline on the evaluation and management of patients with bradycardia and cardiac conduction delay. Circulation. 2018:CIR0000000000000628. doi: https://doi.org/10.1161/CIR.0000000000000628.
- 14.Antonio RS, Chipa-Ccasani F, Apolo J, Linhart M, Trotta O, Pujol-Lopez M, et al. Management of anticoagulation in patients undergoing leadless pacemaker implantation. Heart Rhythm. 2019. https://doi.org/10.1016/j.hrthm.2019.05.016.
- 16.• Duray GZ, Ritter P, El-Chami M, Narasimhan C, Omar R, Tolosana JM, et al. Long-term performance of a transcatheter pacing system: 12-month results from the Micra transcatheter pacing study. Heart Rhythm. 2017;14(5):702–9 The authors report mid-term follow-up of patients from the initial Micra TPS study which led to FDA approval, showing continued efficacy and safety at 12 monhts.CrossRefPubMedGoogle Scholar
- 17.Mont L, Cunnane R, El-Chami MF, Roberts PR, Steffel J, Soejima K, et al. Risk factors for cardiac perforation/effusion in leadless pacemaker patients: experience with the Micra transcatheter pacemaker [abstract]. Heart Rhythm. 2018;18:S119.Google Scholar
- 19.El-Chami MF, Al-Samadi F, Clementy N, Garweg C, Martinez-Sande JL, Piccini JP, 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(12):1800–7.CrossRefPubMedGoogle Scholar
- 24.•• 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 post approval registry. J Cardiovasc Electrophysiol. 2019;30(4):569–74 This sub-study from the Micra Post Approval Registry demonstrated that it is safe to use a leadless pacemaker in those with a prior device infection, even in those who undergo transvenous extraction in the same procedure as leadless pacemaker implant.CrossRefPubMedGoogle Scholar
- 31.Montemerlo E, Pozzi M, Santini F, Piazzi E, Rovaris G. First in man fully leadless transvenous CRT-P with a transseptal implant of WISE-CRT® system and Micra® PM. Pacing Clin Electrophysiol. 2019. https://doi.org/10.1111/pace.13750.