Key result
Dual-chamber leadless pacemaker implantation using a single catheter succeeds in ~98% of cases.
Why the study?
The labeled workflow for the Aveir DR dual-chamber leadless pacemaker calls for a separate delivery catheter for each device, adding cost and procedural steps. Whether the second catheter is actually needed had not been examined in a large series.
Does a single delivery catheter workflow allow feasible acute implantation of both devices of a dual-chamber leadless pacemaker system while lowering direct disposable supply cost in patients undergoing dual-chamber leadless pacing?
Cohort (n=102)
No
Does a single delivery catheter workflow allow feasible acute implantation of both devices of a dual-chamber leadless pacemaker system while lowering direct disposable supply cost in patients undergoing dual-chamber leadless pacing?
Implanting both atrial and ventricular leadless pacemakers using a single delivery catheter was feasible in 98.0% of cases with 98.0% 30-day freedom from complications and reduced direct disposable supply costs by 6.1%.
Answers are grounded in this paper and cite their sources.
May reduce procedural cost and steps with single-catheter Aveir DR implantation; hypothesis-generating and should not yet change practice.
Background: Dual-chamber leadless pacing with the Aveir DR system restores atrioventricular synchrony without transvenous leads. The labeled implant workflow calls for a separate delivery catheter for each device. The second catheter adds cost and adds steps to the procedure, and whether it is actually needed has not been examined in a large series. Objective: To describe the acute procedural feasibility, the rate of delivery-catheter malfunction, and the effect on direct disposable supply cost of implanting both devices of a dual-chamber leadless pacemaker system through one delivery catheter. Methods: We reviewed 102 consecutive patients who received a dual-chamber leadless pacemaker at a single center between February 2024 and February 2025, implanted by five operators at that center. Twenty earlier dual-chamber implants performed with two catheters, before the single-catheter workflow was adopted, precede the study period and are not part of this cohort. The right ventricular device was placed first in every case. The same catheter was then reloaded with the atrial device and used for the second implant, and a new catheter was opened only if the first one failed. We recorded acute implant success, catheter malfunction, procedure time, fluoroscopy time, complications through 30 days after implantation, and direct disposable supply cost. Results: Both devices were implanted through the original catheter in 100 of 102 patients (98.0%, 95% CI 93.1 to 99.8%). Two patients (2.0%, 95% CI 0.2 to 6.9%) needed a catheter exchange because of a mechanical failure that arose during ventricular deployment; in both, the ventricular device had been recaptured and redeployed with repeated torque beforehand. No catheter failed during atrial implantation. Mean time from sheath insertion to removal was 69 min, and mean fluoroscopy time was 16.0 ± 6.6 min. Two device dislodgements occurred (2.0%, 95% CI 0.2 to 6.9%), one intraprocedural and one a right atrial device that embolized the day after implant; neither was related to the delivery catheter. There was no perforation, pericardial effusion, or access-site complication, and no other complication occurred in any patient through 30 days after implant. Omitting the second catheter lowered direct disposable supply cost by 6.1%. Conclusions: With experienced operators, one delivery catheter completed both implants in 98% of cases and lowered disposable supply cost. The study is single arm aand the number of events is small, so these findings support feasibility, with 30-day freedom from complications of 98.0%, and a supply cost difference.
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Kowalski et al. (2026) conducted a cohort in Dual-chamber leadless pacemaker indication (n=102). Single delivery catheter workflow for dual-chamber leadless pacemaker (Aveir DR) implantation was evaluated on Acute implant success of both devices through the original delivery catheter (95% CI 93.1-99.8). Implanting a dual-chamber leadless pacemaker with a single delivery catheter succeeded in 98.0% of cases (95% CI 93.1-99.8%) and lowered direct disposable supply cost by 6.1%.
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