Clinical Outcomes of Non-Atrial Fibrillation Bradyarrhythmias Treated With a Ventricular Demand Leadless Pacemaker Compared With an Atrioventricular Synchronous Transvenous Pacemaker　― A Propensity Score-Matched Analysis ―

Abstract

Background: Implanting a ventricular demand leadless pacemaker (VVI-LPM) for patients with non-atrial fibrillation (AF) bradyarrhythmias such as sick sinus syndrome (SSS) or high-grade (i.e., second-or third-degree) atrioventricular (AV) block is not recommended unless they have limited vascular access or a high infection risk; nevertheless, an unexpectedly high number of VVI-LPM implantations have been performed. This study investigated the clinical outcomes of these unusual uses. Methods and Results:This study retrospectively analyzed 193 patients who were newly implanted with a VVI-LPM or an atrioventricular synchronous transvenous pacemaker (DDD-TPM) for non-AF bradyarrhythmias at a high-volume center in Japan from September 2017 to September 2020. Propensity score-matching produced 2 comparable cohorts treated with a VVI-LPM or DDD-TPM (n=58 each). Each group had 20 (34%) patients with SSS and 38 (66%) patients with high-grade AV block. During a median follow up of 733 (interquartile range 395−997) days, there were no significant differences between the VVI-LPM and DDD-TPM groups regarding late device-related adverse events (0% vs. 4%, log-rank P=0.155), but the VVI-LPM group had a significantly increased readmission rate for heart failure (HF) (29% vs. 2%, log-rank P=0.001) and a tendency to have higher all-cause mortality (28% vs. 4%, log-rank P=0.059). Conclusions:The implantation of a VVI-LPM for non-AF bradyarrhythmias increased the incidence of HF-related rehospitalization at the mid-term follow up compared to the use of a DDD-TPM.

Evolution of tricuspid valve regurgitation after implantation of a leadless pacemaker: A single center experience, systematic review, and meta‐analysis

“…In a smaller study of 53 patients, who were also matched for age and sex, Beurskens et al described worsening of TR in 43% with LLPM versus 38% patients with conventional transvenous systems but this difference was not significant 11 . Similarly, in a propensity score matched analysis of 193 patients with LLPMs and conventional devices, significant TR was more prevalent in transvenous than leadless devices (12% vs. 9%), but again, this difference was not significant 24 …”

“…9%), but again, this difference was not significant. 24 Given the limited evidence, it seems possible that LLPMs may better preserve tricuspid valve function after device implantation as unlike transvenous leads, they do not permanently cross the valve.…”

Emerging Concepts on Infection of Novel Cardiac Implantable Devices

“…LPs implantation after cardiac implantable electronic device (CIED) infection, was successful and reduced recurrence rates [99][100][101][102][103]. Consistently, in the few studies comparing infective complications in LPs and PM patients, PM showed higher rates of these complications [104][105][106].…”

Strategies for Safe Implantation and Effective Performance of Single-Chamber and Dual-Chamber Leadless Pacemakers

“…Despite the absence of leads crossing the TV, LPMs with lengths of 42 mm for the Nanostim, and with lengths of 25.9 mm for the Micra, still have the potential to interact with the valvular apparatus. The aggravation of TR was observed in 12% of patients with LPMs during the 48 month follow-up when compared with 9% of patients with TPMs [ 63 ]. However, an age- and sex-matched analysis showed a higher increase in the TR severity in patients with TPMs than in those with LPMs [ 64 ], and the LPMs had the advantage of reducing the TR effective regurgitant orifice area, compared with conventional leads 1 month after the device implantation [ 65 ].…”

“…It remains to be seen whether non-AF patients will benefit more from DDD-TPMs than VVI-LPMs. A propensity-matched analysis indicated that VVI-LPMs for non-AF bradyarrhythmias significantly increased the rate of heart-failure-related rehospitalization at the 48 month follow-up compared with the use of DDD-TPMs, and a higher but not significant all-cause mortality was observed in patients with VVI-LPMs [ 63 ].…”