What is the clinical evidence from this study?

Study design: Observational. Population: Pacemaker indication with high clinical risk (n=63). Intervention: Leadless pacemakers vs. Conventional CIEDs. Primary outcome: Acute complication rate.

What question did this study set out to answer?

To assess procedural indications, clinical outcomes, and safety of leadless pacemaker implantations among high-risk patients treated at a peripheral medical center.

September 15, 2026European Heart Journal Supplements

Case Series of Leadless Device Implantations in a Peripheral Center: Analysis of Indications and Outcomes

Q: What does this research mean for the field?

Leadless pacemakers demonstrate an excellent safety profile with markedly lower complication and infection rates compared to conventional cardiac implantable electronic devices in high-risk, real-world populations. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

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Key result

Leadless pacemakers linked to ~85% fewer acute complications vs conventional CIEDs in high-risk patients.

n=63

Why the study?

Leadless intracardiac pacemakers were developed to reduce pocket- and lead-related complications associated with conventional CIEDs, such as infections, lead dislodgement, fracture, and septicemia.

Does leadless pacemaker implantation reduce complications compared to conventional CIEDs in a high-risk real-world population?

Key Points

To assess procedural indications, clinical outcomes, and safety of leadless pacemaker implantations among high-risk patients treated at a peripheral medical center.
Analyzed 63 patients (mean age 80.5 years; 49 male) receiving leadless pacemakers (30 single-chamber, 32 VDD dual-chamber, 1 dual-chamber system) between September 2022 and December 2025, with a mean follow-up of 528 days.
Documented high-risk clinical features including renal insufficiency (41%), prior device infection (n=3), limited vascular access (n=18), immunosuppression (n=25), and recurrent sepsis (n=23).
Only one mild vascular complication occurred among leadless pacemaker recipients (arteriovenous fistula with inguinal hematoma, 1/63), which was surgically resolved without affecting survival.
No instances of acute pericardial effusion, device dislodgement, loss of capture, or hospitalizations for device-related sepsis were observed during follow-up.
In contrast, 668 conventional cardiac implantable electronic device procedures at the same center had a 10.8% acute complication rate, including pocket hematoma (5.7%), lead dislodgement (5.4%), pneumothorax (5.1%), and infection (1.8%).

Study Design

Type

Observational (n=63)

Multicenter

Structured PICO

Does leadless pacemaker implantation reduce complications compared to conventional CIEDs in a high-risk real-world population?

Population

63 predominantly male patients (mean age 80.5 years) with high clinical risk and comorbidities undergoing leadless pacemaker implantation, followed for a mean of 528 days.

Exposure

Leadless pacemaker implantation (30 single-chamber devices, 32 VDD dual-chamber devices, and 1 dual-chamber system)

Comparator

668 conventional cardiac implantable electronic device (CIED) procedures performed at the same center between 2024 and 2025

Outcome

Complication rates including acute complications, infections, lead dislodgement, and device-related sepsissafety

Main Result

Absolute Event Rate: 1.6% vs 10.8%

Leadless pacemakers offer a safe alternative to conventional CIEDs with a markedly lower rate of complications and infections in elderly, high-risk patients.

Discussion

No takes yet. Share an insight, caveat, or question.

Implication

May support leadless pacemaker use in high-risk elderly; hypothesis-generating and should not yet change practice.

Cite This Study

Bricco et al. (2026) conducted an observational in Pacemaker indication with high clinical risk (n=63). Leadless pacemakers vs. Conventional CIEDs was evaluated on Acute complication rate. Leadless pacemakers demonstrated a lower rate of acute complications (1.6%) compared with conventional CIED implantation (10.8%) in a high-risk, real-world population.

synapsesocial.com/papers/6aa9017deed42882c1fc1927 https://doi.org/10.1093/eurheartjsupp/suag058.532

Topics

Heart failure HFrEF treatment

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Case Series of Leadless Device Implantations in a Peripheral Center: Analysis of Indications and Outcomes

Key Points

Study Design

Structured PICO

Main Result

Discussion

Implication

Cite This Study

Topics

Case Series of Leadless Device Implantations in a Peripheral Center: Analysis of Indications and Outcomes

Key Points

Study Design

Structured PICO

Main Result

Discussion

Implication

Cite This Study

Also Consider

Topics

Also Consider