What is the clinical evidence from this study?

Study design: Observational. Population: Retrieved leadless pacemakers (n=15). Intervention: Leadless pacemaker retrieval. Primary outcome: Presence of adherent tissue on retrieved leadless pacemakers.

August 28, 2021Heart RhythmOpen Access

Tissues attached to retrieved leadless pacemakers: Histopathological evaluation of tissue composition in relation to implantation time and complications

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Key result

Adherent tissue, primarily consisting of fibrosis and thrombus, was present in 93% (14 of 15) of retrieved leadless pacemakers, potentially affecting retrieval safety.

Why the study?

Encapsulation and tissue adhesions may hamper the safety and efficacy of leadless pacemaker retrieval during device revisions.

What are the histopathological characteristics of tissue adherent to retrieved leadless pacemakers?

Population

15 consecutive successful Nanostim leadless pacemaker retrievals in a tertiary center

Design

Single-center observational study

Authors

KBKarel BreemanUniversity of Amsterdam RLRomy du LongAmsterdam University Medical Centers NBNiek E. G. BeurskensAmsterdam University Medical Centers

Discussion

Member takes

Implication

May complicate leadless pacemaker retrieval; leaves open incidence, risks, and prevention in larger cohorts.

Key Points

To assess the frequency and cellular composition of tissue adherent to retrieved leadless pacemakers and examine its impact on device removal safety.
Analyzed all 15 consecutive successful Nanostim leadless pacemaker retrievals conducted at a single tertiary care center.
Performed histopathological evaluation on adherent tissues and correlated findings with clinical variables, notably implantation duration.
Adherent tissue occurred in 93% of retrievals (14 of 15; median implantation duration 36 months, range 0–96 months).
Tissue composition transitioned from fresh thrombi without fibrosis in short-term retrievals (<1 year) to dense fibrosis with organizing or lytic thrombi in later retrievals, including fibrocellular and fibrosclerotic stages.
Tricuspid valve material was inadvertently removed in 1 patient after 36 months of implantation, precipitating increased tricuspid regurgitation.

Study Design

Type

Observational (n=15)

Multicenter

Structured PICO

What are the histopathological characteristics of tissue adherent to retrieved leadless pacemakers?

Population

15 consecutive patients undergoing successful Nanostim leadless pacemaker retrieval at a tertiary center, with a median implantation duration of 36 months.

Exposure

Histopathological evaluation of adherent tissue following leadless pacemaker retrieval

Outcome

Incidence and cellular characteristics of tissue adherent to retrieved leadless pacemakerssurrogate

Fibrosis and thrombus commonly encapsulate leadless pacemakers, which can adhere to the tricuspid valve apparatus and complicate retrieval.

Cite This Study

Breeman et al. (2021) conducted an observational in Retrieved leadless pacemakers (n=15). Leadless pacemaker retrieval was evaluated on Presence of adherent tissue on retrieved leadless pacemakers. Adherent tissue, primarily consisting of fibrosis and thrombus, was present in 93% (14 of 15) of retrieved leadless pacemakers, potentially affecting retrieval safety.

synapsesocial.com/papers/6a9885280cf752e00cacf568 https://doi.org/10.1016/j.hrthm.2021.08.025

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Tissues attached to retrieved leadless pacemakers: Histopathological evaluation of tissue composition in relation to implantation time and complications

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Cite This Study

Tissues attached to retrieved leadless pacemakers: Histopathological evaluation of tissue composition in relation to implantation time and complications

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Cite This Study

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