Key result
In patients with high-degree AV block, device-collected AM-VP percentage was highly correlated with ECG-determined AV synchrony (R2 = 0.764, p < 0.001).
Why the study?
Real-world operation and reliability of AV synchrony assessment using device data from Micra AV leadless pacemakers had not been described.
Does device-collected %AM-VP correlate with ECG-determined AV synchrony in patients with high-degree AV block using Micra AV leadless pacemakers?
Observational (n=4,424)
Yes
Does device-collected %AM-VP correlate with ECG-determined AV synchrony in patients with high-degree AV block using Micra AV leadless pacemakers?
Effect estimate: R2 = 0.764
p-value: p=<.001
Supports AV synchrony surrogate metrics in Micra AV; leaves open prospective outcome trials before practice change.
Introduction Micra atrioventricular (AV) provides leadless atrioventricular synchronous pacing by sensing atrial contraction (A4 signal). Real‐world operation and reliability of AV synchrony (AVS) assessment using device data have not been described. The purposes of this study were to (1) assess the correlation between AVS and atrial mechanical sensed‐ventricular pacing (AM‐VP) percentages in patients with permanent high‐degree AV block and (2) report on the real‐world effectiveness of Micra AV. Methods The correlation between ECG‐determined AVS in‐clinic and device‐collected %AM‐VP was assessed using data from 40 patients with high‐degree AV block enrolled in the Micra Atrial tRacking using a Ventricular AccELerometer (MARVEL) 2 study. A retrospective analysis to assess continuously‐sampled %AM‐VP since last session, device programming, and electrical parameters was performed using Micra AV transmissions from the Medtronic CareLink database. Patients with transmissions ≥180 days postimplant were included. Results Among the 40 MARVEL 2 AV block patients with a median %VP of 99.7%, AVS was highly correlated with AM‐VP (median AVS 87.1%, median AM‐VP 79.1%; R 2 = 0.764, p < .001). The CareLink cohort included 4384 patients programmed to VDD mode. The mean A4 amplitude was 2.3 ± 1.8 m/s 2 at implant and 2.3 ± 1.6 m/s 2 at 28 weeks. In patients with %VP >90% ( n = 1662), the median %AM‐VP was 74.7%. For the full cohort, median %VP was 65.6% and median projected battery longevity was 10.5 years. Conclusion In patients with a high pacing burden, %AM‐VP provides a reasonable estimation of AVS. The first large real‐world analysis of Micra AV patients with >90% VP showed stable atrial sensing over time with a median %AM‐VP, a correlate of AVS, of 74.7%.
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Garweg et al. (2022) conducted an observational in High-degree AV block (n=4,424). Micra atrioventricular (AV) synchronous leadless pacemaker was evaluated on Correlation between ECG-determined AV synchrony (AVS) and device-collected atrial mechanical sensed-ventricular pacing (AM-VP) percentages (R2 = 0.764, p=<.001). In patients with high-degree AV block, device-collected AM-VP percentage was highly correlated with ECG-determined AV synchrony (R2 = 0.764, p < 0.001).
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