Dataset Information

Procedural Predictors for Bioresorbable Vascular Scaffold Thrombosis: Analysis of the Individual Components of the "PSP" Technique.

ABSTRACT: The technique used at the time of implantation has a central role in determining the risk of thrombosis in bioresorbable vascular scaffolds (BRS). Different definitions of the "optimal" implantation technique exist, however. The impact of individual procedural characteristics on the risk of scaffold thrombosis (ScT) was evaluated in a single-center observational study that enrolled 657 patients (79% males, mean age 63 ± 12 years) with 763 lesions who received a total of 925 BRS for de novo lesions. During a median 1076 (762?1206) days' follow-up there were 28 cases of thrombosis. Independent predictors of ScT included the use of predilatation balloons bigger than the nominal BRS diameter (hazard ratio (HR) = 0.4 (0.16?0.98), p = 0.04), sizing (implantation in vessels with reference vessel diameter >3.5 mm or <2.5 mm: HR = 5.71 (2.32?14.05), p = 0.0002) and the degree of vessel expansion (ratio of minimum lumen to reference vessel diameter, HR: 0.005 (0.0001?0.23), p = 0.007). In addition, a mild BRS oversizing (final BRS diameter to vessel diameter 1.14?1.28) was associated with a lower thrombosis risk, whereas undersizing and more severe oversizing (final BRS diameter to vessel diameter <1.04 and >1.35, respectively) were associated with an increased risk of ScT (HR = 0.13 (0.02?0.59), p = 0.0007). In conclusion, different components of the "optimal" technique have different impacts on the risk of BRS thrombosis. Besides predilatation with a balloon larger than the BRS diameter, correct vessel size selection and a mild to moderate oversizing appear to be protective.

SUBMITTER: Dimitriadis Z

PROVIDER: S-EPMC6352132 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Procedural Predictors for Bioresorbable Vascular Scaffold Thrombosis: Analysis of the Individual Components of the "PSP" Technique.

Dimitriadis Zisis Z Polimeni Alberto A Anadol Remzi R Geyer Martin M Weissner Melissa M Ullrich Helen H Münzel Thomas T Gori Tommaso T

Journal of clinical medicine 20190115 1

The technique used at the time of implantation has a central role in determining the risk of thrombosis in bioresorbable vascular scaffolds (BRS). Different definitions of the "optimal" implantation technique exist, however. The impact of individual procedural characteristics on the risk of scaffold thrombosis (ScT) was evaluated in a single-center observational study that enrolled 657 patients (79% males, mean age 63 ± 12 years) with 763 lesions who received a total of 925 BRS for de novo lesio ...[more]

PMID: 30650586

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Project description:Drug-eluting bioresorbable vascular scaffolds (BVSs) have the potential to restore lumen patency, enable recovery of the native vascular environment, and circumvent late complications associated with permanent endovascular devices. To ensure therapeutic effects persist for sufficient times prior to scaffold resorption and resultant functional loss, many factors dictating BVS performance must be identified, characterized and optimized. While some factors relate to BVS design and manufacturing, others depend on device deployment and intrinsic vascular properties. Importantly, these factors interact and cannot be considered in isolation. The objective of this study is to quantify the extent to which degree of radial expansion modulates BVS performance, specifically in the context of modifying device erosion kinetics and evolution of structural mechanics and local drug elution. We systematically varied degree of radial expansion in model BVS constructs composed of poly dl-lactide-glycolide and generated in vitro metrics of device microstructure, degradation, erosion, mechanics and drug release. Experimental data permitted development of computational models that predicted transient concentrations of scaffold-derived soluble species and drug in the arterial wall, thus enabling speculation on the short- and long-term effects of differential expansion. We demonstrate that degree of expansion significantly affects scaffold properties critical to functionality, underscoring its relevance in BVS design and optimization.Statement of significanceBioresorbable vascular scaffold (BVS) therapy is beginning to transform the treatment of obstructive artery disease, owing to effective treatment of short term vessel closure while avoiding long term consequences such as in situ, late stent thrombosis - a fatal event associated with permanent implants such as drug-eluting stents. As device scaffolding and drug elution are temporary for BVS, the notion of using this therapy in lieu of existing, clinically approved devices seems attractive. However, there is still a limited understanding regarding the optimal lifetime and performance characteristics of erodible endovascular implants. Several engineering criteria must be met and clinical endpoints confirmed to ensure these devices are both safe and effective. In this manuscript, we sought to establish general principles for the design and deployment of erodible, drug-eluting endovascular scaffolds, with focus on how differential expansion can modulate device performance.

Dataset Information

Procedural Predictors for Bioresorbable Vascular Scaffold Thrombosis: Analysis of the Individual Components of the "PSP" Technique.

Publications

Procedural Predictors for Bioresorbable Vascular Scaffold Thrombosis: Analysis of the Individual Components of the "PSP" Technique.

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