Balloon-expandable Stent Deployment Research Articles

Nanoglass‐based balloon expandable stents

Here, a prototypical metallic nanoglass is proposed as a new alloy for balloon expandable stents. Traditionally, the stainless steel SS 316L alloy has been used as a preferred material for this application due to its proper combination of mechanical properties, corrosion resistance, and biocompatibility. Recently, metallic glasses (MGs) have been considered as promising materials for biodevice applications. MGs often display outstanding mechanical properties superior to those of conventional metallic alloys and overcome some of the weaknesses of SS 316L, such as radiopacity, stainless steel allergy, and thrombosis-induced restenosis. However, commonly used monolithic MGs, which have an amorphous homogeneous microstructure, suffer from lack of ductility that is necessary for deployment of balloon expandable stents. In contrast, nanoglasses, that is, amorphous alloys with heterogeneous microstructure, exhibit enhanced ductility which makes them promising materials for balloon expandable stents. We evaluate the feasibility of a prototypical Zr64 Cu36 nanoglass with a grain size of 5 nm for balloon expandable stents by performing finite element method modeling of the stent deployment process in a coronary artery. We consider the BX-Velocity stent design and the nanoglass mechanical properties calculated from atomistic simulations. The results suggest that nanoglasses are suitable materials for balloon expandable stent applications. © 2019 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 108B:73-79, 2020.

On the Importance of Modeling Stent Procedure for Predicting Arterial Mechanics

The stent-artery interactions have been increasingly studied using the finite element method for better understanding of the biomechanical environment changes on the artery and its implications. However, the deployment of balloon-expandable stents was generally simplified without considering the balloon-stent interactions, the initial crimping process of the stent, its overexpansion routinely used in the clinical practice, or its recoil process. In this work, the stenting procedure was mimicked by incorporating all the above-mentioned simplifications. The impact of various simplifications on the stent-induced arterial stresses was systematically investigated. The plastic strain history of stent and its resulted geometrical variations, as well as arterial mechanics were quantified and compared. Results showed the model without considering the stent crimping process underestimating the minimum stent diameter by 17.2%, and overestimating the maximum radial recoil by 144%. It was also suggested that overexpansion resulted in a larger stent diameter, but a greater radial recoil ratio and larger intimal area with high stress were also obtained along with the increase in degree of overexpansion.

Balloon-Expandable Stent Placement in Patients with Immediate Reocclusion after Initial Successful Thrombolysis of Acute Middle Cerebral Arterial Obstruction

We present the results of our approach for treating 12 consecutive cases of acute middle cerebral artery (MCA) stroke by performing balloon-expandable stent (BES) placement after immediate reocclusion due to the underlying stenosis after intra-arterial thrombolysis (IAT). We retrospectively reviewed the clinical outcomes of 12 patients with acute MCA stroke who underwent recanalization by BES placement in an underlying stenosis after IAT. The time to treatment, urokinase dose, duration of the procedure, recanalization rates and symptomatic hemorrhage were analyzed. Clinical outcome measures were assessed on admission and at discharge (the National Institutes of Health stroke scores [NIHSS]) as well as three months after treatment (modified Rankin scales [mRS]). The median NIHSS score on admission was 8.6. Four patients received IV rtPA. The median time from symptom onset to IAT was 236 minutes and the median duration of IAT was 62 minutes. The median dose of urokinase was 140,000 units. Initial recanalization after stent deployment (thrombolysis in cerebral ischemia attack grade of II or III) was achieved in all patients. Two patients died in the hospital due to aspiration pneumonia during medical management. In two patients, in-stent reocclusion occurred within 48 hours after stent deployment. At discharge, the median NIHSS score in ten patients (including the patients with reobstruction) was 2.4. The three-month outcome was excellent (mRS, 0-1) in eight patients. In this study, BES deployment was safe and effective in patients with an immediately reoccluded MCA after successful IAT.

Invited commentary

Invited commentary

Deployment of balloon expandable stents during open repair of thoracoabdominal aortic aneurysms: a new strategy for managing renal and mesenteric artery lesions.

Patients undergoing graft repair of thoracoabdominal aortic aneurysms (TAAAs) often require concomitant correction of ostial stenoses or dissection involving visceral branches. The purpose of this report is to describe our initial experience with a new strategy for addressing these lesions during open TAAA repair-direct deployment of balloon expandable stents into the renal and mesenteric arteries. Over a two-year period, 367 patients have undergone TAAA surgery. Balloon expandable stents were used to manage visceral branch lesions during open TAAA repair in 93 (25.3%) of these patients. Fifteen patients (16%) had preoperative renal insufficiency. After opening the aneurysm and exposing the branch artery ostia, premounted balloon expandable stents were deployed in the affected vessels under direct vision. Stents were deployed after an endarterectomy in 40 patients (43%). Eighty patients (86%) had stents placed in one or both renal arteries and 36 (39%) had stents placed in the celiac axis and/or superior mesenteric artery. Postoperative renal function was monitored with daily serum creatinine levels. There were nine early operative deaths (10%). Two patients (2%) had bleeding complications related to stenting, one of which died after developing multiple organ failure. Twelve patients (13%) developed renal failure, eight of which required dialysis. This study demonstrates the feasibility of treating ostial lesions of the visceral branches with balloon expandable stents during open TAAA repair. Despite a high prevalence of preoperative renal insufficiency, the incidence of postoperative renal failure was acceptable. This new strategy may be a valuable adjunct to TAAA repair and warrants further investigation.

Preintervention arterial remodeling affects vessel stretch and plaque extrusion during coronary stent deployment as demonstrated by three-dimensional intravascular ultrasound

The mechanisms of lumen enlargement during stent implantation may be significantly affected by arterial remodeling. To assess effects of lesion remodeling, we performed 3-dimensional intravascular ultrasound (IVUS) analyses in 55 coronary lesions before and after deployment of balloon-expandable stents. Standard quantitative analysis was performed, and arterial remodeling was assessed by the remodeling index (target site divided by mean of proximal and distal reference segment vessel areas), which classified lesions into group A (remodeling index ≤1, negative or intermediate remodeling, n = 40) or group B (remodeling index >1, positive remodeling, n = 15) lesions. Characteristics of the 55 patients and the interventional procedures were similar in the 2 groups. IVUS demonstrated that stenting resulted in increased lumen and vessel dimensions and in a reduced plaque size (p ≤0.001 each) in both group A and group B lesions. The extent of lumen increase inside the stents was almost identical, but resulted from different mechanisms: (1) vessel stretch was greater in group A (p <0.002 at minimum lumen site); (2) plaque compression (or embolization) tended to be greater in group B (p = 0.05, along entire stented segment); (3) plaque redistribution within the stent was observed in both groups (p <0.005 both); and (4) significant (p <0.01) plaque extrusion into the distal reference segment was found in group B only. Thus, the remodeling pattern of coronary lesions has a significant impact on the mechanisms of lumen enlargement during stent deployment. Lesions with positive remodeling show more plaque extrusion into the distal reference and less stent-induced vessel stretch than those with negative remodeling.

Management of Unexpected Balloon Rupture During Deployment of Balloon-Expandable Stents

Management of Unexpected Balloon Rupture During Deployment of Balloon-Expandable Stents