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A Novel Tram Stent Method in the Treatment of Coronary Bifurcation Lesions - Finite Element Study.

ABSTRACT: A novel stent was designed for the treatment of coronary bifurcation lesion, and it was investigated for its performance by finite element analysis. This study was performed in search of a novel method of treatment of bifurcation lesion with provisional stenting. A bifurcation model was created with the proximal vessel of 3.2 mm diameter, and the distal vessel after the side branch (2.3 mm) was 2.7 mm. A novel stent was designed with connection links that had a profile of a tram. Laser cutting and shape setting of the stent was performed, and thereafter it was crimped and deployed over a balloon. The contact pressure, stresses on the arterial wall, stresses on the stent, the maximal principal log strain of the main artery and the side-branch were studied. The study was performed in Abaqus, Simulia. The stresses on the main branch and the distal branch were minimally increased after deployment of this novel stent. The side branch was preserved, and the stresses on the side branch were lesser; and at the confluence of bifurcation on either side of the side branch origin the von-Mises stress was marginally increased. The stresses and strain at the bifurcation were significantly lesser than the stresses and strain of the currently existing techniques used in the treatment of bifurcation lesions though the study was primarily focused only on the utility of the new technology. There is a potential for a novel Tram-stent method in the treatment of coronary bifurcation lesions.

SUBMITTER: Arokiaraj MC

PROVIDER: S-EPMC4777498 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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A Novel Tram Stent Method in the Treatment of Coronary Bifurcation Lesions - Finite Element Study.

Arokiaraj Mark C MC De Santis Gianluca G De Beule Matthieu M Palacios Igor F IF

PloS one 20160303 3

A novel stent was designed for the treatment of coronary bifurcation lesion, and it was investigated for its performance by finite element analysis. This study was performed in search of a novel method of treatment of bifurcation lesion with provisional stenting. A bifurcation model was created with the proximal vessel of 3.2 mm diameter, and the distal vessel after the side branch (2.3 mm) was 2.7 mm. A novel stent was designed with connection links that had a profile of a tram. Laser cutting a ...[more]

PMID: 26937643

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Project description:BackgroundProvisional 1-stent technique is currently regarded as the default approach for the majority of bifurcation lesions. Nonetheless, 2-stent techniques may be required for complex bifurcations with high compromise risk or fatal consequences of side branch (SB) occlusion. Limitations exist in current approaches, as stents gap, multiple metal layers and stent malapposition caused by imprecise placement with fluoroscopic guide and intrinsic technical defects. This study was designed to investigate the effectiveness of the novel Szabo 2-stent technique for coronary bifurcation lesions.MethodsIn the Szabo 2-stent technique, one stent is precisely implanted at the SB ostium with Szabo technique resulting in a single strut protruding into the main vessel (MV). After MV rewiring and SB guidewire withdrawal, another stent is implanted in MV followed by proximal optimization technique, SB rewiring, and final kissing inflation (FKI).ResultsThe technique tested successfully in silicone tubes (n = 9) with: procedure duration, 31.2 ± 6.8 min; MV and SB rewiring time, 26.8 ± 11.2 s and 33.3 ± 15 s; easy FKI; and 2.3 ± 0.5 balloons/procedure. Bifurcation lesions (n = 22) were treated with angiographic success in MV and SB, respectively: increased minimal lumen diameter (0.63 ± 0.32 mm to 3.20 ± 0.35 mm; 0.49 ± 0.37 mm to 2.67 ± 0.25 mm); low residual stenosis (12.4 ± 2.4%; 12.4 ± 2.3%); and intravascular ultrasound confirmed (n = 19) full coverage; minimal overlap and malapposition; minimal lumen area (2.4 ± 1.2 mm2; 2.1 ± 1.0 mm2); plaque burden (78.1 ± 11.3%; 71.6 ± 15.5%); and minimal stent area (9.1 ± 1.6 mm2; 6.1 ± 1.3 mm2). Periprocedural cardiac troponin increased in 1 asymptomatic patient without electrocardiographic change. There was no target lesion failure (cardiac death, myocardial infarction, target lesion revascularization) at 6-month follow-up.ConclusionsThe Szabo 2-stent technique for bifurcation lesions provided acceptable safety and efficacy at short-term follow-up.

Project description:Side-branch occlusion is a serious complication of provisional one-stent strategies used to treat coronary bifurcation lesions. The aim of the study was to compare the short- and long-term clinical outcomes between the balloon-stent kissing technique (BSKT) and jailed wire technique (JWT) in patients with non-left coronary bifurcation lesions.This prospective, double-blinded, randomized controlled study enrolled 89 consecutive patients (aged 18-85 years) with 90 true bifurcation lesions (hemadostenosis ≥70%; bifurcation angle <90°; Medina classification 1.1.1, 1.0.1, or 0.1.1) who underwent percutaneous coronary intervention (PCI) at the Zhongshan Hospital Affiliated to Dalian University (China) between January 2013 and May 2016. The patients were randomly divided into the BSKT (44 patients, 45 lesions) and JWT (45 patients, 45 lesions) groups. The intervention was conducted according to technical requirements using a single-stent strategy. Operative success rate, occurrence of complications, postoperative quantitative coronary angiography, and incidence of perioperative and long-term major adverse cardiovascular events (MACEs) were compared between groups.The intervention success rate was 100% in both groups. After main-branch stenting, the BSKT was associated with significantly lower rates of side-branch occlusion (0% vs 15.6%, P < .05) and side-branch post-processing (8.9% vs 26.7%, P < .05) than the JWT. The BSKT was associated with significantly lower degrees of postoperative proximal main-branch residual stenosis (6.1 ± 5.1% vs 9.6 ± 8.6%, P < .05) and side-branch ostial stenosis (51.6 ± 20.6% vs 70.3 ± 20.8%, P < .05) than the JWT. The incidence of perioperative MACEs was significantly lower in the BSKT group than in the JWT group (0% vs 13.3%, P < .05). Patients were followed for a mean duration of 19.0 ± 6.1 months. The occurrence rates of long-term MACEs, angina of Canadian Cardiovascular Society grade ≥2, and severe heart failure were not significantly different between groups.The BSKT is a safe and effective technique that may have advantages over the JWT with regard to protection of the side-branch during PCI for bifurcation lesions.

Project description:Background and objectiveThe modified double-stent and provisional stenting strategies have been widely used in patients with coronary bifurcation lesions, but what is the optimization has not been clearly defined. This meta-analysis is to elucidate the benefits from modified double-stent and provisional stenting strategies in patients with coronary bifurcation lesions.MethodsElectronic databases were searched to identify studies comparing the modified double-stent and provisional stenting strategies in patients with coronary bifurcation lesions. The clinical outcomes were divided into early (≤6 months) and late (>6 months) events according to the follow-up duration. The early endpoints included cardiac death, myocardial infarction, target lesion revascularization or target vessel revascularization, and major adverse cardiac events (MACE), and the late endpoints also include stent thrombosis in addition to the early endpoints index. The angiographic endpoint was in-stent restenosis. Data were analyzed by the statistical software RevMan (version 5.3).ResultsA total of 6 studies involving 1683 patients with coronary bifurcation lesions were included in this meta-analysis, which found that the modified double-stent strategy was associated with a lower risk of cardiac death (odds ratio [OR] = 0.29, 95% confidence intervals [CI] 0.11-0.78, P = .01), myocardial infarction (OR = 0.41, 95% CI 0.21-0.82, P = .01), target lesion revascularization or target vessel revascularization (OR = 0.31, 95% CI 0.15-0.63, P = .001), and MACE (OR = 0.41, 95% CI 0.22-0.74, P = .003) compared with provisional stenting in the early follow-up endpoint events, while the risk of cardiac death and stent thrombosis were similar between both strategies (OR = 0.59, 95% CI 0.31-1.10, P = .09; and OR = 0.62, 95% CI 0.34-1.15, P = .13; respectively) in the late follow-up endpoint events. There were significant differences between both strategies in myocardial infarction (OR = 0.42, 95% CI 0.24-0.75, P = .003), MACE (OR = 0.44, 95% CI 0.31-0.62, P < .00001), and target lesion revascularization or target vessel revascularization (OR 0.35, 95% CI 0.25-0.49, P < .00001) between both strategies in the late follow-up endpoint events. The risk of in-stent restenosis favored the modified double-stent strategy (OR 0.29, 95% CI 0.20-0.43, P < .00001).ConclusionThe modified double-stent strategy is associated with excellent clinical and angiographic outcomes except for the occurrence of cardiac death and stent thrombosis late-term outcome compared with provisional stenting strategy in patients with coronary bifurcation lesions. These findings suggest that the modified double-stent strategy can be recommended as an optimization in patients with coronary bifurcation lesions.

Dataset Information

A Novel Tram Stent Method in the Treatment of Coronary Bifurcation Lesions - Finite Element Study.

Publications

A Novel Tram Stent Method in the Treatment of Coronary Bifurcation Lesions - Finite Element Study.

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