What question did this study set out to answer?

To compare short- and mid-term complications, reinterventions, heart failure hospitalizations, and all-cause mortality between AVEIR DR dual-chamber leadless pacemakers and dual-chamber transvenous pacemakers.

January 18, 2026Journal of Cardiovascular ElectrophysiologyOpen Access

Leadless Versus Transvenous Dual‐Chamber Pacemakers: Real‐World Evidence From AVEIR DR Coverage With Evidence Development Study

Q: What are the key findings of this study?

The AVEIR DR leadless pacemaker reduced device-related complications by 49% and overall 6-month complications by 41% compared to transvenous pacemakers, with similar mortality rates.

Q: What does this research mean for the field?

The AVEIR DR leadless pacemaker reduced device-related complications by 49% and overall 6-month complications by 41% compared to transvenous pacemakers, with similar mortality rates. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

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Key result

AVEIR DR leadless pacemakers linked to ~49% fewer device-related complications vs transvenous pacemakers.

Why the study?

Evaluating the early real-world comparative safety of the AVEIR DR dual-chamber leadless pacemaker compared to dual-chamber transvenous pacemakers is important.

Does a dual-chamber leadless pacemaker reduce complications and mortality compared to transvenous dual-chamber pacemakers in Medicare beneficiaries?

Key Points

To compare short- and mid-term complications, reinterventions, heart failure hospitalizations, and all-cause mortality between AVEIR DR dual-chamber leadless pacemakers and dual-chamber transvenous pacemakers.
Retrospective cohort analysis evaluated Medicare Fee-for-Service claims from October 2023 to December 2024, examining de novo implants of AVEIR DR leadless pacemakers (N = 759) versus transvenous pacemakers (N = 77 422).
Patients were required to have continuous coverage for at least 12 months prior to implantation and at least 30 days post-procedure without prior cardiac implantable electronic devices.
Outcomes at 30 days and 6 months were adjusted for baseline demographics, comorbidity burden, and hospital encounter characteristics using multivariable modeling.
Adjusted 30-day overall complications (7.9% vs. 9.2%; OR 0.85, 95% CI 0.60 to 1.20, p = 0.36) and all-cause mortality (1.8% vs. 1.5%; HR 1.21, 95% CI 0.72 to 2.02, p = 0.47) were comparable, while 30-day device-related complications were significantly lower with leadless devices (2.0% vs. 3.9%; OR 0.50, 95% CI 0.31 to 0.82, p < 0.01).
At 6 months, leadless pacing was associated with significantly lower adjusted overall complications (4.1% vs. 6.9%; HR 0.59, 95% CI 0.40 to 0.86, p < 0.01), device-related complications (2.8% vs. 5.9%; HR 0.48, 95% CI 0.30 to 0.75, p < 0.01), and device reinterventions (2.1% vs. 4.3%; HR 0.49, 95% CI 0.30 to 0.80, p < 0.01).
No significant differences occurred at 6 months for adjusted all-cause mortality (6.6% vs. 5.6%; HR 1.18, 95% CI 0.79 to 1.76, p = 0.43) or heart failure hospitalizations (3.8% vs. 4.1%; HR 0.91, 95% CI 0.60 to 1.37, p = 0.65).

Structured PICO

Does a dual-chamber leadless pacemaker reduce complications and mortality compared to transvenous dual-chamber pacemakers in Medicare beneficiaries?

Population

78,181 Medicare Fee-for-Service beneficiaries (n=759 leadless pacemaker, n=77,422 transvenous pacemaker) undergoing de novo dual-chamber pacemaker implantation. Mean age 78.5 (leadless) and 79.6 (transvenous), 39.8% female (leadless). Key inclusion: at least 12 months of continuous Medicare FFS coverage prior to implant and coverage for at least 30 days post-implant.

Intervention

Dual-chamber leadless pacemaker (AVEIR DR)

Comparator

Dual-chamber transvenous pacemakers from all manufacturers

Outcome

Overall acute complication rate (periprocedural adverse events within 30 days of implant) and all-cause mortality rate within 30 days of implantsafety

In a real-world Medicare population, dual-chamber leadless pacemakers were associated with significantly fewer 6-month complications and reinterventions compared to transvenous pacemakers, despite being implanted in patients with higher comorbidity burdens.

Discussion

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Implication

May support leadless preference in comorbid patients; extends observational data but leaves open need for randomized confirmation.

Cite This Study

Lo et al. (2026) studied this question. The AVEIR DR leadless pacemaker reduced device-related complications by 49% and overall 6-month complications by 41% compared to transvenous pacemakers, with similar mortality rates.

synapsesocial.com/papers/696c77d4eb60fb80d1396007 https://doi.org/10.1111/jce.70255

Topics

Persistent AF management Atrial fibrillation HFrEF treatment Heart failure AF ablation outcomes

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