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Review

A review on the treatment of intimal hyperplasia with perivascular medical devices: role of mechanical factors and drug release kinetics

, &
Pages 805-819 | Received 01 Apr 2023, Accepted 02 Aug 2023, Published online: 10 Aug 2023
 

ABSTRACT

Introduction

Intimal hyperplasia (IH) is a significant factor limiting the success of revascularization surgery for blood flow restoration. IH results from a foreign body response and mechanical disparity that involves complex biochemical reactions resulting in graft failure. The available treatment option utilizes either different pharmacological interventions or mechanical support to the vascular grafts with limited success.

Areas covered

This review explains the pathophysiology of IH, responsible mechanical and biological factors, and treatment options, emphasizing perivascular devices. They are designed to provide mechanical support and pharmacology actions. The perivascular drug delivery concept has successfully demonstrated efficacy in various animal studies. Accurate projections of drug release mechanisms using mathematical modeling could be used to formulate prolonged drug elution devices. Numerical modeling aspects for the prediction of design outcomes have been given due importance that fulfills the unmet clinical need for better patient care.

Expert opinion

IH could be effectively prevented by simultaneous mechanical scaffolding and sustained local drug delivery. Future perivascular medical devices could be designed to integrate these essential features. Numerical modeling for device performance prediction should be utilized in the development of next-generation perivascular devices.

Article highlights

  • Intimal hyperplasia (IH) significantly reduced the success of revascularization surgical procedures such as coronary artery bypass grafting (CABG), saphenous vein grafts (SVGs), and arteriovenous (AV) fistula for hemodialysis.

  • IH is an intense foreign body response involving complex biochemical reactions resulting in blood vessel narrowing.

  • Available treatment focuses on the systemic administration of pharmacology agents and external mechanical support. The most promising treatment would be the drug–device combination using perivascular drug-eluting medical devices such as wraps, sheaths, and coils.

  • The drug release kinetics could be optimized using computational mathematical modeling. These methods would accelerate the device development program by precisely finding the factors governing the drug elution kinetics. The mathematical models could be further explored to design future drug-eluting implantable perivascular devices.

Abbreviations and nomenclature

AV=

Arteriovenous

CABG=

Coronary artery bypass grafting

a=

radius of a cylinder or sphere or the half-thickness of a slab

a0=

initial radius

b0=

initial thickness

c0=

initial drug concentration within the matrix

D=

Diffusion coefficient of drug within the polymeric matrix

Ds=

Diffusion coefficient of the solvent

EC=

Endothelial cell

ECM=

Extracellular matrix

EEL=

External elastic lamina

fPCL=

fraction of PCL

fPLGA=

fraction of PLGA

h=

Thickness of the device

HMG-CoA=

Hydroxy methyl glutaryl co-enzyme A

IEL=

Internal elastic lamina

IH=

Intimal hyperplasia

k=

Release constant of Higuchi (Higuchi model)

ka=

radial erosion rate constant

kb=

axial erosion rate constant

kd=

Disentanglement rate of polymer chains

kd=

Kinetic dissolution constant (Zero order)

krt=

constant for geometrical characteristics and structural modifications of the system (Ritger-Peppas model)

K1=

First order rate constant (First order)

k1 and k2=

Constants (Peppas and Sahlin, Alfrey model)

l=

Half thickness of the polymer

M0=

Total mass of drug incorporated within the device

Md and Mt=

Amount of drug released at time t

Md,∞ and M=

Amount of drug released at infinite time

m=

Fickian diffusion exponent of the system (Peppas-Sahlin model)

n=

shape factor (n = 3 for spherical; n = 2 for cylindrical and n = 1 for slab)

n=

exponent of drug release (Ritger-Peppas model)

ɸb,PCL=

fraction of burst release from PCL phase

PCI=

Percutaneous coronary interventions

PCL=

Poly ε-caprolactone

PEG=

Polyethylene glycol

PLA=

Poly lactic acid

PLGA=

Poly lactic-co-glycolic acid

PPG=

Polypropylene glycol

PTFE=

Polytetrafluoroethylene

SFA=

Superficial femoral artery

SMC=

Smooth muscle cell

υ1,eq and υd,eq=

Equilibrium concentrations of solvent and drug respectively

υ1* and υd*=

Characteristic concentrations of solvent and drug respectively

VSMC=

Vascular smooth muscle cell

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewers disclosure

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/17434440.2023.2244875

Additional information

Funding

This paper was not funded.

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