Reduced fibrous capsule elastic fibers from biologic ECM-enveloped CIEDs in minipigs, supported with a novel compression mechanics model

BACKGROUND: Fibrous capsules (Fb) in response to cardiovascular implantable electronic devices (CIEDs), including a pacemaker (P) system, can produce patient discomfort and difficulties in revision surgery due partially to their increased compressive strength, previously linked to elevated tissue fibers.

OBJECTIVE: A preliminary study to quantify structural proteins, determine if biologic extracellular matrix-enveloped CIEDs (PECM) caused differential Fb properties, and to implement a realistic mechanical model.

METHODS: Retrieved Fb (-P and -PECM) from minipigs were subjected to biomechanical (shear oscillation and uniaxial compression) and histological (collagen I and elastin) analyses.

RESULTS: Fb-PECM showed significant decreases compared to Fb-P in: low strain-loss modulus (390 vs. 541 Pa) across angular frequencies, high strain-compressive elastic modulus (1043 vs. 2042 kPa), and elastic fiber content (1.92 vs. 3.15 μg/mg tissue). Decreases in elastin were particularly noted closer to the implant's surface (Fb-PECM = 71% vs. Fb-P = 143% relative to dermal elastin at mid-tangential sections) and verified with a solid mechanics hyperelasticity with direction-dependent fiber viscoelasticity compression simulation (r2 ≥ 98.9%).

CONCLUSIONS: The biologic envelope composed of decellularized porcine small intestine submucosa ECM for CIEDs promoted fibrous tissues with less elastic fibers. Novel compression modeling analyses directly correlated this singular reduction to more desirable subcutaneous tissue mechanics.

Medienart:

E-Artikel

Erscheinungsjahr:

2023

Erschienen:

2023

Enthalten in:

Zur Gesamtaufnahme - volume:34

Enthalten in:

Bio-medical materials and engineering - 34(2023), 4 vom: 04., Seite 289-304

Sprache:

Englisch

Beteiligte Personen:

de Guzman, Roche C [VerfasserIn]
Meer, Allison S [VerfasserIn]
Mathews, Aidan A [VerfasserIn]
Israel, Atara R [VerfasserIn]
Moses, Michael T [VerfasserIn]
Sams, Clarence M [VerfasserIn]
Deegan, Daniel B [VerfasserIn]

Links:

Volltext

Themen:

3D distribution
9007-58-3
Biologic envelope
Biological Products
COMSOL multiphysics hyperelastic simulation
Cardiovascular implantable electronic devices
Compression biomechanics
Decellularized tissue ECM
Elastin
Elastin and elastic fibers
Fibrous tissue encapsulation
Foreign body reaction
Journal Article
Minipig study
Oscillation rheology
Pacemaker

Anmerkungen:

Date Completed 11.07.2023

Date Revised 22.07.2023

published: Print

Citation Status MEDLINE

doi:

10.3233/BME-221488

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM351288643