Investigating Balloon-Vessel Contact Pressure Patterns in Angioplasty: In Silico Insights for Drug-Coated Balloons

Stratakos, Efstathios; Antonini, Luca; Poletti, Gianluca; Berti, Francesca; Tzafriri, Abraham R.; Petrini, Lorenza; Pennati, Giancarlo

doi:10.1007/s10439-023-03359-y

Cited by 7 publications

(1 citation statement)

References 59 publications

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“…For drug-coated balloons, the coating transfer efficiency is presumed to be influenced by the tissue mechanics due to influencing the contact pressure between the device and the arterial wall [138]. In silico investigations show impact of vessel stiffness on contact pressure, proposing an impact on drug delivery [139].…”

Section: Model Attributesmentioning

confidence: 99%

Cardiovascular Tissue Engineering Models for Atherosclerosis Treatment Development

Tscheuschner,

Tzafriri

2023

Bioengineering

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In the early years of tissue engineering, scientists focused on the generation of healthy-like tissues and organs to replace diseased tissue areas with the aim of filling the gap between organ demands and actual organ donations. Over time, the realization has set in that there is an additional large unmet need for suitable disease models to study their progression and to test and refine different treatment approaches. Increasingly, researchers have turned to tissue engineering to address this need for controllable translational disease models. We review existing and potential uses of tissue-engineered disease models in cardiovascular research and suggest guidelines for generating adequate disease models, aimed both at studying disease progression mechanisms and supporting the development of dedicated drug-delivery therapies. This involves the discussion of different requirements for disease models to test drugs, nanoparticles, and drug-eluting devices. In addition to realistic cellular composition, the different mechanical and structural properties that are needed to simulate pathological reality are addressed.

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Section: Model Attributesmentioning

confidence: 99%

Cardiovascular Tissue Engineering Models for Atherosclerosis Treatment Development

Tscheuschner,

Tzafriri

2023

Bioengineering

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Do Balloon Catheters have a Different Radial Force Along Their Longitudinal Axis?

Choi,

Kim,

Won

2024

Cardiovasc Intervent Radiol

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Purpose This experimental study was designed to compare radial forces between the central portion and both ends of balloon catheters when dilating stenosis. Materials and Methods Three balloon catheters of 6 and 8 mm in diameter and of variable length were tested: Mustang, Conquest, and Genoss PTA. Cylindrical modules to position balloon catheters and install the measuring tip during radial force measurements were made using a 3D printer. The measuring tip created 20% stenosis at the inner lumen. Both ends and center of the balloon catheter were located at the measuring tip. The radial force was measured after inflating the balloon catheter to the rated burst pressure. Results For the different diameters and lengths of balloon catheters and cylinder sizes, the median inccenter, the radial rease in radial force at the distal end compared to the center was 16.5% (range: 9.8–35.2%) for Mustang, 12.4% (range: 10.3–25.5%) for Genoss, and 7.4% (range: −0.3–13.1%) for Conquest balloon catheters. Similarly, compared to that at the force at the proximal end was 10.8% greater (range: −2.9–18.3%) for Mustang, 9.9% greater (range: 3.9–22.3%) for Genoss, and 7.3% greater (range: −1.3–12.4%) for Conquest catheters. Conclusion The radial force is greater at both ends of the balloon than at the central portion, especially at the distal end. Dilation using the distal end of the balloon catheter is a practical method that can be applied in clinical practice without additional devices when encountering resistant stenosis, especially with semi-compliant balloons. Graphical Abstract

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A Novel In Silico–Ex Vivo Model for Correlating Coating Transfer to Tissue with Local Drug-Coated Balloon-Vessel Contact Pressures

Stratakos,

Tscheuschner,

Vincenzi

et al. 2024

Ann Biomed Eng

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Drug-coated balloons (DCBs) aim to deliver drug-loaded surface coating upon inflation at specific vascular sites, yet the role of inflation pressure remains to be defined. We implement a new approach combining ex vivo stamping experiments with in silico simulations to study acute coating transfer by commercial DCBs. This methodology comprises 3 essential pillars: (I) DCB resin inflation and slicing into cylindrical segments for subsequent stamping onto porcine-excised tissue, (II) Numerical inflation of a full DCB replica in an idealized porcine vessel to predict in vivo interfacial contact pressures (CPs) and subsequent interfacial-level numerical stamping to calculate appropriate benchtop forces that recreate these in vivo CP values, and (III) ex vivo stamping experiments and optical analysis of the stamped surfaces (DCB segment and arterial tissue), using a standard high-resolution camera to visualize coating. High-performance liquid chromatography (HPLC) was employed as a validated assay for quantifying drug in tissue samples post-stamping. HPLC analysis revealed a significant correlation with image processing, confirming the validity of the optical method as a tool to quantify DCB coating. Image and HPLC analysis revealed a statistically significant twofold rise in coating area and drug content to tissue, respectively, when the average CP roughly doubled (0.16–0.35 atm) and a non-statistically significant increase in coating area and drug content with a further rough doubling of average CP (0.35 to 0.75 atm). Imaging of DCB segments pre- and post-stamping showed transfer of partial coating thickness at low CP, contrasting with complete transfer at high CP at the same site. 3D confocal images of DCB surfaces revealed variable thickness in the transferred coating. This study introduces a comprehensive methodology for evaluating the efficacy of commercial DCB coating transfer to arterial tissue—a crucial precursor to drug elution studies—while minimizing the number of DCBs needed and improving variable control and realism.

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Investigating Balloon-Vessel Contact Pressure Patterns in Angioplasty: In Silico Insights for Drug-Coated Balloons

Cited by 7 publications

References 59 publications

Cardiovascular Tissue Engineering Models for Atherosclerosis Treatment Development

Cardiovascular Tissue Engineering Models for Atherosclerosis Treatment Development

Do Balloon Catheters have a Different Radial Force Along Their Longitudinal Axis?

A Novel In Silico–Ex Vivo Model for Correlating Coating Transfer to Tissue with Local Drug-Coated Balloon-Vessel Contact Pressures

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