Arrhythmias & electrophysiologyCohort study
Aveir VR real-world performance and chronic pacing threshold prediction using mapping and fixation electrical data
- Prospective cohort study
- retrospective comparison cohort
Authors' conclusion
Aveir VR demonstrated satisfactory performance in this high-risk cohort. Pacing thresholds tend to improve to a greater extent than Micra after implantation. The PCT after fixation, even after a waiting period, has limited predictive value for the chronic threshold. Low-mapping PCT and high intraoperative impedance predict chronic low PCT.
Study context
- Population
- Real-world patients receiving Aveir VR leadless pacemaker; mostly advanced age and small body size88 reached 3-month follow-up
- Participants
- 123 vs 139
- Exposure
- Aveir VR vs Micra
- Aveirn = 123
- Micran = 139reference
- Outcome
- Predictors of pacing threshold (PCT); high PCT ≥1.5 V, excellent PCT ≤0.5 V
- Follow-up
- 3 months
Main finding
As reported in the abstract
Predictors of 3-month PCT (Aveir)
- Correlated with impedance at mapping
- P = 0.015
- Correlated with tether mode impedance
- P < 0.001
- Correlated with end-of-procedure impedance
- P < 0.001
- Correlated with mapping pacing threshold (PCT)
- P = 0.035
- Not correlated with PCTs after fixation
- P > 0.05
- Tether mode impedance >470 ohms predicting excellent 3-month PCT: sensitivity
- 88%
- Tether mode impedance >470 ohms predicting excellent 3-month PCT: specificity
- 71%
Observational data: associations, not effects.
Further findings
High PCT at end of procedure
P = 0.004
High PCT · 3 months
P = 1.000
- Implant success (Aveir)
- 99.2% · 122 of 123
- Implant success (Aveir): of 123 attempts
Safety
Complications (Aveir)
- Patients with complications: 1 pericardial effusion after device reposition, 1 intraoperative device dislodgement
- 2 (1.6%)
Original publication
Aveir VR real-world performance and chronic pacing threshold prediction using mapping and fixation electrical data. Europace. Published 8 March 2024. doi:10.1093/europace/euae051
Summarised from the published abstract; every number is checked against it