Leadless pacemaker: a game changer

Approximately 200,000 pacemakers are implanted every year within the United States, and with an aging population and increasing indications for cardiac pacing, this number is predicted to extend (Bhatia and El-Chami, 2018). Although these devices are effective, roughly one in eight patients experience early complications, normally related to the transvenous lead or subcutaneous pocket. These complications include pneumothorax/hemothorax, cardiac perforation, lead dislocation/integrity issues, pocket infections/hematomas, endocarditis, vascular occlusion, and tricuspid regurgitation (Bhatia and El-Chami, 2018). Pacemaker technology has advanced rapidly in an effort to cut back complications and improve treatment outcomes.

Lead-free pacemakers were first proposed within the Seventies and ultimately gained FDA approval in 2016 (Bhatia and El-Chami, 2018). These are miniature, lead-free pacing systems which might be sufficiently small to be placed in the center and avoid the necessity for a subcutaneous pocket and transvenous electrodes, that are the weakest points of traditional pacemakers (Vouliotis, 2023). The leadless pacemaker is the scale of a dime, free-standing, and inserted through a femoral venous access, and in chosen patients it may possibly be inserted through the neck (Link, 2024). The pacemaker is attached to the proper ventricular myocardium and released. The delivery system is then removed and the pacemaker stays embedded in the proper ventricle. Two systems are currently available: Micra (Medtronic) and Aveir (Abbott). Micra received FDA approval in 2016 and Aveir in 2022 (Link, 2024).

Lead-free pacemakers have a battery lifetime of five to 10 years, which is comparable to traditional devices (Grippe, 2019). Initial models allowed for VVI or VVIR pacing (ventricular on-demand pacing, during which only the ventricle is paced and sensed, and the heartbeat generator inhibits pacing in response to the sensed ventricular event). A more recent model, called Micra AV, offers the power to keep up AV synchronization by detecting atrial activity and pacing the ventricle using an accelerometer-based algorithm, thereby providing VDD pacing. Additionally, there may be Aveir DR, which is an investigational device that involves implanting one device in the proper atrium and one device in the proper ventricle to make sure AV synchronization (Link, 2024).

Preliminary reports of long-term treatment effectiveness and complications are promising, including few complications, few system revisions, and stable stimulation parameters. These pacemakers could also be a great option for patients who’ve difficult vascular access, those that have an expected low pacing burden (i.e., severe recurrent vasovagal syncope), an expected high risk of infection, or those that have had a previous infection of an implanted cardiac device (Link, 2024). Leadless pacemakers are also cosmetically attractive because they haven’t any chest incision or visible pacemaker pocket and are MRI compatible (Grippe, 2019).

Future developments on this specialized field include converting kinetic energy from cardiac motion to power a pacemaker, enabling the event of a battery-free pacemaker, a wireless left ventricular pacing system, potentially using lead-free pacemakers with subcutaneous defibrillators (Vouliotis et al., 2023). .

Bhatia, N. and El-Chami, M. (2018). Leadless pacemakers: a up to date review. , (4), 249–253. https://doi.org/10.11909/j.issn.1671-5411.2018.04.002

Grippe, Georgia (2019). Lead-free pacemaker: revolutionary design that increases the pacemaker’s capabilities. , 32(6), 48-50. https://www.doi.org/10.1097/01.JAA.0000554750.85170.d4

Link, M. (2024, March). Permanent cardiac pacing: an outline of devices and indications. https://www.uptodate.com/contents/permanent-cardiac-pacing-overview-of-devices-and-indications

Vouliotis, A., Roberts, P., Dilavernis, P., Gatzowlis, K., Yue, A., and Tsioufis, K. (2023). Lead-free pacemakers: current achievements and future prospects. 18:e49. https://www.doi.org/10.15420/ecr.2022.32