Changes to Polymer Surface of Drug-Eluting Stents During Balloon Expansion

Denardo, Scott J.; Carpinone, Paul L.; Vock, David M.; Batich, Christopher D.; Pepine, Carl J.

doi:10.1001/jama.2012.4111

Cited by 31 publications

(25 citation statements)

References 4 publications

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“…Coated stents were then expanded to 14 atm in DI water at 37°C, as previously described (Denardo et al, 2012, Basalus et al, 2009). PA-YK-NO coated unexpanded stents were used as controls, and the coatings were analyzed as follows.…”

Section: Methodsmentioning

confidence: 99%

Evaluation of the effect of expansion and shear stress on a self-assembled endothelium mimicking nanomatrix coating for drug eluting stents in vitro and in vivo

et al. 2014

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Coating stability is increasingly recognized as a concern impacting the long-term effectiveness of drug eluting stents (DES). In particular, unstable coatings have been brought into focus by a recent published report (JAMA 2012). Towards the goal of overcoming current challenges of DES performance, we have developed an endothelium mimicking nanomatrix coating composed of peptide amphiphiles that promote endothelialization, but limit smooth muscle cell proliferation and platelet adhesion. Here, we report a novel water evaporation based method to uniformly coat the endothelium mimicking nanomatrix onto stents using a rotational coating technique, thereby eliminating residual chemicals and organic solvents, and allowing easy application to even bioabsorbable stents. Furthermore, the stability of the endothelium mimicking nanomatrix was analyzed after force experienced during expansion and shear stress under simulated physiological conditions. Results demonstrate uniformity and structural integrity of the nanomatrix coating. Preliminary animal studies in a rabbit model showed no flaking or peeling, and limited neointimal formation or restenosis. Therefore, it has the potential to improve the clinical performance of DES by providing multifunctional endothelium mimicking characteristics with structural integrity on stent surfaces.

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Section: Methodsmentioning

confidence: 99%

Evaluation of the effect of expansion and shear stress on a self-assembled endothelium mimicking nanomatrix coating for drug eluting stents in vitro and in vivo

et al. 2014

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“…While vascular devices undergo friction, durability, and particulate trials required by the United States Food and Drug Administration (USP XXII sec 788) [17], risks associated with intravascular polymer applications are not fully recognized by the medical community [12,13,18,19]. To date, the clinicopathological effects associated with HPE in patients have not been systematically evaluated.…”

Section: Introductionmentioning

confidence: 99%

Hydrophilic polymer embolism and associated vasculopathy of the lung: prevalence in a retrospective autopsy study

et al. 2015

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Hydrophilic polymers are commonly applied as surface coatings on vascular devices and have been shown to dissociate during endovascular use, causing hydrophilic polymer embolism (HPE). Adverse effects related to this phenomenon have been recognized and reported. The prevalence of this complication is unknown. We conducted a retrospective study to determine the prevalence of HPE among hospital autopsies over a 29-month period. Postmortem tissue was histologically evaluated for the presence, location(s) and extent of HPE. HPE findings were correlated with documented clinical and laboratory data and patient outcome. Of 136 hospital autopsies examined, 18 (13%) showed evidence of HPE involving the lungs (n = 18), heart (n = 1) or central nervous system (n = 1). Localized pulmonary HPE was seen in 12 patients (9%). Multifocal pulmonary HPE was found in 6 patients (4%) and was associated with clinical vasculitis (33%; P < .0001), suspected pulmonary ischemia (50%; P = .008), coagulopathy (67%; P = .002), and constitutional disease (83%; P = .01). Within affected lung, associated histopathologic changes included occlusive intravascular or perivascular inflammation (89%), intravascular fibrous response (56%), microthrombus formation (44%), vasculitis (28%), and/or pulmonary microinfarction (28%). Statistically significant differences in hospital days (P = .008) and number of vascular interventions (P = .01) were noted between affected and unaffected patients. We conclude that HPE is an underdiagnosed phenomenon with primary involvement of the lungs, where secondary vascular changes are common. Additional studies may be needed to clarify risks and to identify preventative strategies for this iatrogenic complication of catheterizations and “minimally invasive” endovascular techniques.

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“…The results reflect the effect of functional groups on the surface and allow us to determine the type of the surface. The contact angle values of Co-Cr surface 11 before and after modifications are presented in Table 1 respectively. These values are attributed to the presence of PCL brushes at the Co-Cr surface and in agreement with the contact angle of PHEMA-co-PCL film that was 76 o [41].…”

Section: 2characterization Of the Co-cr Surfaces Modificationsmentioning

confidence: 99%

“…Up to date, the current commercially available DESs still suffer from weak adhesion between the polymer coating and stent surface. This weakness resulted in polymer detachment and delamination during and after stent deployments could lead to the stent action failure [9][10][11][12][13][14][15][16] and, therefore might increase the likelihood of stent thrombosis and/or restenosis [17].…”

Section: Introductionmentioning

confidence: 99%

Effects of interfacial layer wettability and thickness on the coating morphology and sirolimus release for drug-eluting stent

Bedair

et al. 2015

Journal of Colloid and Interface Science

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Changes to Polymer Surface of Drug-Eluting Stents During Balloon Expansion

Cited by 31 publications

References 4 publications

Evaluation of the effect of expansion and shear stress on a self-assembled endothelium mimicking nanomatrix coating for drug eluting stents in vitro and in vivo

Evaluation of the effect of expansion and shear stress on a self-assembled endothelium mimicking nanomatrix coating for drug eluting stents in vitro and in vivo

Hydrophilic polymer embolism and associated vasculopathy of the lung: prevalence in a retrospective autopsy study

Effects of interfacial layer wettability and thickness on the coating morphology and sirolimus release for drug-eluting stent

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