Key result
Ventricular-demand leadless pacemakers linked to ~8-fold greater mortality and more HF readmissions vs. transvenous pacemakers.
Why the study?
The clinical outcomes of ventricular-demand leadless pacemaker usage for new-onset high-grade AV block after TAVR had not been elucidated.
Does ventricular-demand leadless pacemaker therapy improve clinical outcomes compared to atrioventricular synchronous transvenous pacemaker therapy in patients with new-onset high-grade AV block after TAVR?
Observational (n=39)
No
Does ventricular-demand leadless pacemaker therapy improve clinical outcomes compared to atrioventricular synchronous transvenous pacemaker therapy in patients with new-onset high-grade AV block after TAVR?
In patients with high-grade AV block after TAVR, VVI-LPM therapy was associated with higher 2-year all-cause mortality and heart failure readmission compared to DDD-TPM therapy, though this may be confounded by baseline frailty and malnutrition.
Answers are grounded in this paper and cite their sources.
Caution advised with VVI leadless pacemakers post-TAVR AV block; leaves open confounding by frailty and need for randomized trials.
However, the clinical outcomes of this unusual usage are not elucidated. Patients who received permanent pacemakers (PPMs) owing to new-onset high-grade AV block after TAVR from September 2017 to August 2020 at a high-volume center in Japan were included in the analysis, and the clinical courses of VVI-LPM and DDD-TPM implants through 2 years of follow-up were compared retrospectively. Out of 413 consecutive patients who underwent TAVR, 51 (12%) patients received a PPM. After excluding 8 patients with chronic atrial fibrillation (AF), 3 with sick sinus syndrome, and 1 with incomplete data, 17 VVI-LPMs and 22 DDD-TPMs were included in our final cohort. The VVI-LPM group had lower serum albumin levels (3.2 0.5 vs. 3.9 0.4 g/dL, P < .01) than the DDD-TPM group. Follow-up revealed no significant differences between the 2 groups in terms of the incidence of late device-related adverse events (0% vs. 5%, log-rank P = .38) and new-onset AF (6% vs. 9%, log-rank P = .75); however, there were increases in the rates of all-cause death (41% vs. 5%, log-rank P < .01) and heart failure rehospitalization (24% vs. 0%, log-rank P = .01) in the VVI-LPM group. This small retrospective study reveals favorable post-procedural complication rates but higher all-cause mortality with VVI-LPM compared to DDD-TPM therapy for high-grade AV block after TAVR at 2 years of follow-up.
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Togashi et al. (2023) conducted an observational in New-onset high-grade atrioventricular block after transcatheter aortic valve replacement (n=39). Ventricular-demand leadless pacemaker (VVI-LPM) vs. Atrioventricular synchronous transvenous pacemaker (DDD-TPM) was evaluated on All-cause mortality at 2 years (p=<0.01). Ventricular-demand leadless pacemakers were associated with higher all-cause mortality (41% vs. 5%) and heart failure rehospitalization (24% vs. 0%) compared to transvenous pacemakers at 2 years.
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