Leadless Pacing: Current State and Future Direction

Abstract

Leadless pacing is now an established alternative to conventional pacing with subcutaneous pocket and transvenous lead for patients with class I or II single-chamber pacing indication. Available 12-month follow-up data shows a 48% fewer major complication rate in patients with Micra™ compared to a historical control group in a nonrandomized study [1]. There is one system with Food and Drug Administration (FDA) approval and two with the Communauté Européenne (CE) mark. The OPS code for the implantation is 8–83d.3 and the procedure has recently been rated as a “new Examination and Treatment Method (NUB)” in the German DRG system, meaning adequate reimbursement is negotiable with health insurance providers. The systems offer similar generator longevity and programming possibilities as conventional pacemaker systems, including rate response, remote monitoring, and MRI safety. The biggest downsides to date are limitations to single-chamber stimulation, lack of long-time data, and concerns of handling of the system at the end of its life span. However, implant procedure complication rates and procedure times do not exceed conventional pacemaker operations, and proper training and patient selection is provided.

The feasibility of leadless pacemaker implantation for superelderly patients

“…The Micra Transcatheter Pacing System (Micra TPS, Medtronic), which does not depend on transvenous (TV) leads, has emerged as an alternative to the TV single‐chamber pacemaker for prevention of the symptoms related to bradyarrhythmias 5‐7 . The Micra TPS is a miniaturized single‐chamber pacemaker system that is implanted directly into the right ventricle (RV), eliminating the need for device pocket creation or insertion of a pacing lead, thereby avoiding some of the complications associated with traditional pacing systems 6,7 . Many techniques and recommendations for leadless pacemaker (LP) implantation and follow‐up have been developed through various worldwide experiences.…”

Influence of implantation access on complication rates in pacemaker implantation: An analysis of quality insurance data

“…For some time, leadless pacing for single chamber stimulation is an alternative to conventional implantation via VC or VS. However, long term data are still lacking [27].…”

Human Body Communication Channel Characterization for Leadless Cardiac Pacemakers

“…Simulations show that the lowest attenuation is achieved when the RA capsule is vertically fixed at the top wall of the heart, where the attenuation reaches levels that are less than 60dB for frequencies higher than 10 MHz. By the way, it is worth noting the complementary behavior of RAA and Horizontal positions in the frequency region [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20]MHz. RAA position has a lower attenuation at 4MHz reaching a value of 73.8 dB, while Horizontal position attenuation experiences a slight increase in a frequency range between 1 MHz and 4 MHz reaching 77dB at 2MHz.…”

“…It consists of a small capsule, anchored in one of the heart chambers, that can integrate all the functionalities of standard pacemakers. The technological bottleneck that prevents LCP to completely replace standard pacemakers stands in power budget limits for communication purposes [8]. Human Body Communication (HBC) is an ultra-low power communication that is a good candidate to overcome telemetry power budget issues.…”