Prospective multicenter study of the breakable babystent for treatment of aortic coarctation in newborns and infants.

To assess the efficacy and safety of a breakable BabyStent to treat complex aortic coarctation (CoA) in early childhood. Although recommended in several guidelines, there is no approved aortic stent for young infants, because of the dilemma between two mandatory requirements: expandable up to adult size on the one hand, and small enough to fit through a baby's femoral artery on the other. Prospective interventional, multi-center clinical trial with the breakable Osypka BabyStent® (OBS). The OBS is a low-profile, 15-mm long cobalt-chromium stent, pre-mounted on a 6 mm balloon and inserted via a 4 Fr sheath. After implantation, its diameter is adjustable from 6 to 12 mm by balloon dilation. Further dilation opens predefined joints enabling unrestricted growth. Nineteen patients (9 male), median age 112 days (range: 7-539), median body weight 5.6 kg (range: 2.4-8.4) were deemed high risk and underwent stent implantation. Of those, 74% suffered from re-CoA following surgery, 53% had additional cardiac and 21% noncardiac malformations. Our primary combined endpoint was fulfilled: All stents were implanted in the desired region, and a >50% intrastenotic diameter-extension was achieved in 15 patients (78.9%, 80% confidence interval [62.2; 90.5], 95% confidence interval [54.4; 93.9]). Secondary endpoint confirmed that the OBS fits the baby's femoral vessel diameter. All children survived the procedure and 12-month follow-up. This stent enables percutaneous stenting of complex aortic coarctation to treat high-risk newborns and infants.

Elastic stent recoil in coronary total occlusions: Comparison of durable-polymer zotarolimus eluting stent and ultrathin strut bioabsorbable-polymer sirolimus eluting stent.

OBJECTIVES: To compare stent recoil (SR) of the thin-strut durable-polymer Zotarolimus-eluting stent (dp-ZES) and the ultrathin-strut bioabsorbable-polymer Sirolimus-eluting stent (bp-SES) in chronic total occlusions (CTOs) and to investigate the predictors of high SR in CTOs. BACKGROUND: Newer ultrathin drug eluting stent might be associated with lower radial force and higher elastic recoil due to the thinner strut design, possibly impacting on the rate of in-stent restenosis and thrombosis. METHODS: Between January 2017 and November 2019, consecutive patients with CTOs undergoing percutaneous coronary intervention were evaluated. Only patients treated with dp-ZES or bp-SES were included and stratified accordingly. Quantitative coronary angiography analysis was used to assess absolute SR, relative SR, absolute focal SR, relative focal SR, high absolute, and high relative focal SR. RESULTS: A total of 128 lesions (67 treated with dp-ZES and 61 with bp-SES) in 123 patients were analyzed. Between bp-SES and dp-ZES no differences were found in absolute SR (p = .188), relative SR (p = .138), absolute focal SR (p = .069), and relative focal SR (p = .064). High absolute and high relative focal SR occurred more frequently in bp-SES than in dp-ZES (p = .004 and p = .015). Bp-SES was a predictor of high absolute focal SR (Odds ratio [OR] 3.29, 95% confidence interval [CI] 1.50-7.22, p = .003]. High-pressure postdilation and bp-SES were predictors of high relative focal SR (OR 2.22, 95% CI 1.01-4.86, p = .047; OR 2.74, 95% CI 1.24-6.02, p = .012, respectively). CONCLUSIONS: Both stents showed an overall low SR. However, ultra-thin strut bp-SES was a predictor of high absolute and high relative focal SR.

Introduction of a New ex vivo Porcine Coronary Artery Model: Evaluation of the Direct Vascular Injury after Stent Implantation with and without Dogbone Effect.

INTRODUCTION: Neointimal hyperplasia after percutaneous coronary intervention remains a major determinant of in-stent restenosis (ISR). The extent of mechanical vessel injury correlates with ISR. A new ex vivo porcine stent model was introduced and evaluated comparing different stent designs. METHODS: Coronary arteries were prepared from pig hearts from the slaughterhouse and used for ex vivo implantations of coronary stents. One basic stent design in two configurations (dogbone, DB; nondogbone, NDB) was used. Vascular injury was determined according to a modified injury score (IS). RESULTS: Standardized experimental conditions ensured comparable vessel dimensions and overstretch data. DB stents caused more severe IS compared to NDB stents. The mean IS and the IS at the distal end of all stents were significantly reduced for NDB stents (ISMean, DB, 1.16 ± 0.12; NDB, 1.02 ± 0.12; p = 0.018; ISDist, DB, 1.39 ± 0.28; NDB, 1.13 ± 0.24; p = 0.03). DISCUSSION/CONCLUSION: The introduced ex vivo model allowed the evaluation of different stent designs, which exclude unfavorable stent designs.

Comparison of open- and closed-cell stent design outcomes after carotid artery stenting in the Vascular Quality Initiative.

BACKGROUND: The association between stent design and outcomes after carotid artery stenting (CAS) has remained controversial. The available data are conflicting regarding the superiority of any specific stent design. The present study investigated the association between cell design and outcomes after carotid artery stenting (CAS) in a real world setting. METHODS: Patients who had undergone CAS with distal embolic protection in the Society for Vascular Surgery Vascular Quality Initiative (VQI) database from 2016 to 2018 were included in the present study. Patients undergoing CAS for trauma or dissection or more than two treated lesions were excluded. We also excluded lesions for which more than two carotid stents had been used and lesions confined to the common or external carotid artery. Univariable and multivariable logistic regression analyses were used to compare the outcomes after CAS between the open- and closed-cell stent designs. RESULTS: Of the 2671 CAS procedures included in the present analysis, 1384 (51.8%) had used closed-cell stents and 1287 (48.2%) had used open-cell stents. On univariable analysis, no significant differences were noted between the closed- and open-cell stents in in-hospital mortality (1.8% vs 1.4%; P = .40), stroke (1.8% vs 2.4%; P = .28), and stroke/death (3.3% vs 3.5%; P = .81). After adjusting for potential confounders (ie, age, symptomatic status, previous major amputation, statin and antiplatelet use, American Society of Anesthesiologists class, elective procedures, approach, and post-stent dilatation), no difference was noted in in-hospital stroke/death between the two stent designs (odds ratio [OR], 1.08; 95% confidence interval [CI], 0.68-1.74; P = .74). However, the interaction between stent design (open vs closed) and lesion location (bifurcation vs internal carotid artery [ICA]) was statistically significant (P = .02). Closed-cell stents were associated with five times the odds of in-hospital stroke/death when used in carotid artery bifurcation (OR, 5.5; 95% CI, 1.3-22.2; P = .02). However, when the stent was limited to the ICA, no differences were noted (OR, 0.87; 95% CI, 0.51-1.45; P = .62). One-year follow-up data were available for 19% of patients. No differences in ipsilateral stroke or death at 1 year were noted between the open- and closed-cell stents, except when the lesion was located in the carotid bifurcation (hazard ratio, 6.7; 95% CI, 1.4-31.4; P = .02). CONCLUSIONS: Closed-cell stents were associated with an increased odds of in-hospital stroke/death for carotid bifurcation lesions, which might be related to the relatively lower conformability of closed-cell stents in the tortuous and diameter-mismatched bifurcation anatomy vs the relatively linear uniform diameter of the ICA. Improved follow-up and in-depth analysis of lesion-specific characteristics that might influence the outcomes of these two designs are needed to validate these results.

Impact of bridging stent design and configuration on branch vessel durability after fenestrated endovascular repair of complex aortic aneurysms.

OBJECTIVE: The ideal mating stent for target vessel revascularization in fenestrated endovascular aneurysm repair (FEVAR) of juxtarenal and thoracoabdominal aortic aneurysms remains unknown. The objective of this study was to assess the outcomes associated with use of different stent types and configurations mated with reinforced fenestrations during FEVAR. METHODS: Clinical data from patients undergoing FEVAR for juxtarenal and thoracoabdominal aortic aneurysms in a prospective physician-sponsored investigational device exemption trial were analyzed. Outcomes for two different balloon-expandable covered stents (BECSs) mated with reinforced fenestrations were assessed along with the impact of distal extension with a self-expanding stent (SES). Primary patency, branch-related endoleak, and reintervention rates were determined. Cox proportional hazards model was used for time-to-event analysis. RESULTS: From 2001 to 2016, there were 918 patients who underwent fenestrated or branched endograft repair of complex aortic aneurysms; 1604 renal arteries (RAs), 714 superior mesenteric arteries (SMAs), and 333 celiac arteries (CAs) were mated with reinforced fenestrations using JOMED (n = 2014; Abbott Vascular, Santa Clara, Calif) or iCAST (n = 637; Atrium Medical, Hudson, NH) BECSs. The type of BECS did not affect short-term or long-term patency, branch-related endoleaks, or reintervention rates in the RA, SMA, or CA. Twenty-five percent (402/1604) of RAs, 84% (598/714) of SMAs, and 8% (27/333) of CAs underwent distal SES extension at the index operation. RAs with a distal SES in addition to the BECS had a higher likelihood of an occlusion event (hazard ratio, 2.791; 95% confidence interval, 1.42-5.48; P = .003) and reinterventions (P = .036) compared with those without an SES. Addition of a distal SES to the BECS in the SMA or CA did not have an impact on patency or reintervention rates. CONCLUSIONS: BECS choice does not appear to have an impact on branch durability after FEVAR. Selective distal SES placement in RAs with high-risk anatomy does not appear to significantly protect against an occlusion event or to prevent secondary interventions. Routine addition of a distal SES does not improve SMA fenestration durability.

Mid-term outcomes of the Pulsta transcatheter pulmonary valve for the native right ventricular outflow tract.

OBJECTIVES: The aim of this study is to present the mid-term outcomes of Pulsta valve. BACKGROUND: The Pulsta valve is a Self-expandable knitted nitinol-wire stent mounted with a treated tri-leaflet α-Gal-free porcine pericardial valve for percutaneous pulmonary valve implantation (PPVI) in patients with native right ventricular outflow tract (RVOT) lesions. METHODS: A multi-center clinical trial using Pulsta valve® was designed for patients with severe pulmonary regurgitation (PR) in the native RVOT in multiple centers in South Korea and 25 patients were enrolled. Before PPVI, severe PR (mean PR fraction: 45.5 ± 6.9%) and enlarged RV volume (mean indexed RV end-diastolic volume; 169.7 ± 13.0 ml/m2 ) was present. The mean age was 21.6 ± 6.6 years old. RESULTS: All patients were successfully implanted with 26, 28, or 32 mm diameter of Pulsta valve loaded on the 18 or 20 French delivery catheters. At 6 months follow up, indexed RV end-diastolic volume was decreased to 126.9 ± 16.9 ml/m2 . At mean 33.1 ± 14.3 months follow-up, the mean value of mean pressure gradient in Pulsta valve was 6.5 ± 3.0 mmhg without significant PR. There was no serious device-related adverse event. CONCLUSIONS: A multi-center clinical trial was completed successfully with planned Pulsta valve implantation and demonstrated good mid-term effectiveness without device-related serious adverse events.

Edwards SAPIEN XT transcatheter pulmonary valve implantation: 5-year follow-up in a French Registry.

OBJECTIVES: This study sought to investigate patient intermediate-term outcomes after transcatheter pulmonary valve replacement (TPVR) with Edwards SAPIEN valve. BACKGROUND: The Edwards SAPIEN valve, initially designed for percutaneous aortic valve replacement, has been approved for TPVR in patients with dysfunctional right ventricular outflow tracts (RVOT), but only short-term follow-up has been reported. METHODS: From 2011 to 2016, 62 patients undergoing successful TPVR using the SAPIEN XT valve were consecutively included into the study. Primary efficacy and safety endpoints were defined as freedom from valve-reintervention and freedom from infective endocarditis at last follow-up, respectively. RESULTS: The primary efficacy outcome was met for 87.1% patients after a mean follow-up of 4.6 ± 1.8 years, corresponding to a freedom of reintervention at 5 years of 89% (95% CI 74.8-95.6%). Reinterventions were exclusively due to recurrent obstruction, no significant valvular regurgitation was observed. One case of infective endocarditis was reported, corresponding to a rate of 0.35% per patient-year (95% CI 0.01-2.00%). At 5 years, freedom from infective endocarditis was 98.4% (95% CI 89.1-99.8%). Six patients died or were transplanted due to advanced cardiac failure, without relationship with TPVR. In univariate analysis, reintervention was associated with young age, a smaller tube-graft, a higher pulmonary valve gradient after the procedure and a ratio of largest implanted stent diameter to invasive balloon conduit diameter over 1.35. CONCLUSIONS: This study documents the mid-term safety and efficacy of the Edwards SAPIEN XT valve in patients with dysfunctional RVOT, and identifies a patient profile associated with an uncertain benefit-risk balance.

Design optimization of a cardiovascular stent with application to a balloon expandable prosthetic heart valve.

A cardiovascular stent design optimization method is proposed with application to a pediatric balloon-expandable prosthetic heart valve. The prosthetic valved conduit may be expanded to a larger permanent diameter in vivo via subsequent transcatheter balloon dilation procedures. While multiple expandable prosthetic heart valves are currently at different stages of development, this work is focused on one particular design in which a stent is situated inside of an expandable polymeric valved conduit. Since the valve and conduit must be joined with a robust manufacturing technique, a polymeric glue layer is inserted between the two, which results in radial retraction of the valved region after expansion. Design of an appropriate stent is proposed to counteract this phenomenon and maintain the desired permanent diameter throughout the device after a single non-compliant balloon dilation procedure. The finite element method is used to compute performance metrics related to the permanent expansion diameter and required radial force. Additionally, failure due not only to high cycle fatigue but also due to ductile fracture is incorporated into the design study through the use of an existing ductile fracture criterion for metals. Surrogate models are constructed with the results of the high fidelity simulations and are subsequently used to numerically obtain a set of Pareto-optimal stent designs. Finally, a single design is identified by optimizing a normalized aggregate objective function with equal weighting of all design objectives.

Poly (l-lactic acid) bioresorbable scaffolds versus metallic drug-eluting stents for the treatment of coronary artery disease: A meta-analysis of 11 randomized trials.

BACKGROUND: Bioresorbable vascular scaffolds (BVS) have been proposed for overcoming the long-term limitations of permanent metallic stents, while theoretically warranting similar advantages in plaque stabilization and anti-restenotic drug delivery in the early postrevascularization phase. However, increased rates of malapposition, restenosis, or thrombosis have emerged from initial trials with BVS, that were nevertheless underpowered for the evaluation of the real outcome benefits of these coronary devices. The recent completion of newer randomized clinical trials paves the way to the present meta-analysis, aiming at the comparison of Poly (l-Lactic acid) BVS (PLLA-BVS) versus metallic drug-eluting stents (DES) in the treatment of coronary stenoses. METHODS: Literature and main scientific session abstracts were searched for randomized clinical trials (RCTs) comparing drug-eluting BVS versus metallic DES for the treatment of coronary artery disease (CAD). The primary efficacy endpoint was mortality, secondary endpoints were cardiovascular death, myocardial infarction, target lesion revascularization (TLR), stent thrombosis and the composite of device-oriented target lesion failure (TLF). RESULTS: We included 11 randomized trials, for a total population of 10,707 patients, 54.5% treated with BVS. The major indication for PCI was stable CAD, whereas acute coronary syndrome represented 30% of the patients. At a mean follow-up of 2.64 years (1-5 years), mortality occurred in 2.71% of the patients, with no difference according to the type of implanted stent (OR[95%CI] = 0.94 [0.74, 1.20], p = .62). No interaction was observed according to patients' risk profile or the rate of diabetes and ACS. However, a significant increase in myocardial infarction, stent thrombosis, TLR and TLF was observed with BVS as compared to DES. CONCLUSIONS: The present meta-analysis provides the most updated data on the use of PLLA-BVS for the treatment of CAD. We documented a poorer performance of these new coronary devices, as compared to new generation metallic DES, being associated with an increased rate of recurrent cardiovascular events. However, such ischemic complications did not impact on mortality, with a comparable survival independently from the type of stent.

Evaluation of a novel mesh-covered stent for treatment of carotid stenosis in patients at high risk for endarterectomy: 1-year results of the SCAFFOLD trial.

OBJECTIVE: The SCAFFOLD trial evaluated the GORE® Carotid Stent (GCS), a novel, mesh-covered device and evaluated outcomes at 1 year. BACKGROUND: SCAFFOLD was a prospective, multicenter, single-arm clinical trial in patients with severe carotid artery stenosis (angiographically defined as symptomatic ≥50% or asymptomatic ≥80%) at increased risk for adverse events from carotid endarterectomy. Interim 30-day analysis demonstrated low rates of death/stroke/myocardial infarction (DSMI; 3.0%) and stroke (1.1%) in a high surgical risk population. METHODS: The rate of DSMI within 30 days plus ipsilateral stroke between 31 days and 1 year (primary endpoint) was compared to a predetermined performance goal. Secondary outcomes of freedom from clinically driven target lesion revascularization (CD-TLR; diameter stenosis ≥80% by core lab angiography, or ≥50% with clinical symptoms) and restenosis (≥80% diameter stenosis by core lab angiography) are reported as Kaplan-Meier (KM) estimates. RESULTS: Of the 312 patients enrolled and treated, 264 were eligible per protocol and evaluable for major adverse events at 30 days, and 244 (92%) of these were evaluable at 1 year. The proportion of patients with DSMI at 1 year was 4.5% and was significantly lower than the prespecified performance goal of 16.9% (p < .00001). The proportion with ipsilateral stroke from 31 to 365 days was 1.2%. The KM estimates of 1-year event probability were 1.6% for CD-TLR and 1.2% for restenosis. CONCLUSIONS: Use of the mesh-covered GCS in the SCAFFOLD trial demonstrated 100% technical success and low rates of both periprocedural and late stroke, with durable patency at 1 year. ClinicalTrials.gov Identifier: NCT01901874 (redacted).

Comparison of long-term clinical outcomes in multivessel coronary artery disease patients treated either with bioresoarbable polymer sirolimus-eluting stent or permanent polymer everolimus-eluting stent: 5-year results of the CENTURY II randomized clinical trial.

OBJECTIVES: To assess the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimus-eluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patients with multivessel coronary artery disease (MVD) enrolled in the CENTURY II trial. BACKGROUND: The use of coronary stenting in high-risk subgroups, like MVD patients, is rising. The clinical evidence, including long-term comparative analysis of the efficacy and safety benefits of different new-generation drug eluting stents, however, remains insufficient. METHODS: Among 1,119 patients (intention-to-treat) enrolled in the CENTURY II prospective, randomized, single-blind, multicenter trial, a prespecified subgroup of 456 MVD patients were allocated by stratified randomization to treatment with BP-SES (n = 225) or PP-EES (n = 231). The previously reported primary endpoint of this study was freedom from target lesion failure (TLF: a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization) at 9 months. RESULTS: In this MVD substudy, baseline patient, lesion and procedure characteristics were similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p = .29 and 10.2 vs. 13.4%; p = .29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p = .33 and 0.9 vs. 1.7%; p = .43), respectively. Composite endpoint of cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations were also similar. CONCLUSIONS: These results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population.

[Design and materials for ureteral stents: past, present and future].

Ureteral stents have a long history of use. Their main goal is to provide effective drainage of the upper urinary tract. Morbidity is mostly related to low biocompatibility of materials, from which stents are made. Since stent introduction, there have been many stages of evolution and modernization. However, there is a significant problem associated with their widespread use. Despite technological progress, stent-associated symptoms, incrustation, bacterial infection are the problems that still have to be resolved while creating an "ideal" stent. The continued development of new materials and coatings also will lead to the improvement of such an indispensable urological device as the ureteral stent.

A meta-analysis of the effect of stent design on clinical and radiologic outcomes of carotid artery stenting.

OBJECTIVE: Procedural characteristics, including stent design, may influence the outcome of carotid artery stenting (CAS). A thorough comparison of the effect of stent design on outcome of CAS is thus warranted to allow for optimal evidence-based clinical decision making. This study sought to evaluate the effect of stent design on clinical and radiologic outcomes of CAS. METHODS: A systematic search was conducted in MEDLINE, Embase, and Cochrane databases in May 2018. Included were articles reporting on the occurrence of clinical short- and intermediate-term major adverse events (MAEs; any stroke or death) or radiologic adverse events (new ischemic lesions on postprocedural magnetic resonance diffusion-weighted imaging [MR-DWI], restenosis, or stent fracture) in different stent designs used to treat carotid artery stenosis. Random effects models were used to calculate combined overall effect sizes. Metaregression was performed to identify the effect of specific stents on MAE rates. RESULTS: From 2654 unique identified articles, two randomized, controlled trials and 66 cohort studies were eligible for analysis (including 46,728 procedures). Short-term clinical MAE rates were similar for patients treated with open cell vs closed cell or hybrid stents. Use of an Acculink stent was associated with a higher risk of short-term MAE compared with a Wallstent (risk ratio [RR], 1.51; P = .03), as was true for use of Precise stent vs Xact stent (RR, 1.55; P < .001). Intermediate-term clinical MAE rates were similar for open vs closed cell stents. Use of open cell stents predisposed to a 25% higher chance (RR, 1.25; P = .03) of developing postprocedural new ischemic lesions on MR-DWI. No differences were observed in the incidence of restenosis, stent fracture, or intraprocedural hemodynamic depression with respect to different stent design. CONCLUSIONS: Stent design is not associated with short- or intermediate-term clinical MAE rates in patients undergoing CAS. Furthermore, the division in open and closed cell stent design might conceal true differences in single stent efficacy. Nevertheless, open cell stenting resulted in a significantly higher number of subclinical postprocedural new ischemic lesions detected on MR-DWI compared with closed cell stenting. An individualized patient data meta-analysis, including future studies with prospective homogenous study design, is required to adequately correct for known risk factors and to provide definite conclusions with respect to carotid stent design for specific subgroups.

The combined use of stent retriever and neuro-aspiration as successful bail-out reperfusion strategy in a patient with embolic myocardial infarction.

Embolic myocardial infarction account for ≈3% of all ST-segment myocardial infarction and represents a challenge often left no-reperfused because current thrombectomy technologies are inefficient to grab thrombus wedged into distal coronary arteries. We present the case of a 34-year-old man who presented with anterior STEMI and a proximal left anterior descending coronary artery ulcerated plaque with a great thrombus burden, which led to distal embolization. Failure of several attempts of manual and rheolytic thrombectomy, led us to use the "Solumbra technique", the combined use of stent retriever and Penumbra catheter was successful in restoring patency and flow.

A novel unembalmed human cadaveric limb model for assessing conformational changes in self-expanding nitinol stents in the popliteal artery.

OBJECTIVE: To develop an unembalmed human cadaveric lower limb model as a more realistic environment for testing self-expanding nitinol stents. We studied conformational changes and strain induced by knee flexion in nitinol stents deployed in the popliteal artery (PA). METHODS: One Lifestent® each was deployed into one limb of four cadavers (control group), while the contralateral leg received a different stent (Absolute®, Protégé Everflex®, Supera®, and Gore Viabahn®). The limbs were mounted on a quasi-static knee rig (QKR) and X-ray imaging was performed at pre-defined knee flexion angles. A least-squares solution to the equation of a circle was used to assess radius of curvature at flexion points (FP), and nominal strain was calculated for each stented artery. RESULTS: There were differences but also some similarities in conformational changes seen in the various stents. Knee flexion produced at least two FP in all stents. The mean radius of curvature decreased with increasing degrees of flexion but more so in distal (main) than proximal (accessory) FP (22 mm vs. 11 mm) in all stents. Supera® stent had the greatest relative radii of curvatures, and Absolute® stent had the highest strain value in comparison to the contralateral PA as the control group. CONCLUSION: This study describes a novel human cadaveric limb model for testing self-expanding nitinol stents implanted in the PA. Several parameters of conformational change in the stented PA such as FP formation, FP translocation and strain induced by axial compression were described. These may be useful for developing new stents for the PA location.

Dutch multicenter experience using the STENTYS Xposition S self-apposing stent in complex coronary lesions.

OBJECTIVES: The aim is to assess the experience in the Netherlands using the Xposition S self-apposing stent in complex coronary lesions in clinical practice. BACKGROUND: Treatment of complex coronary lesions could be accompanied with stent sizing difficulties and complications, particularly due to vessel overdilation or stent underexpansion. The self-apposing feature of the Xposition S stent (STENTYS, Paris, France) supports good strut apposition in complex anatomies and allows for an increase in diameter after implantation. METHODS: In this real-world registry, data from patients treated with Xposition S in four Dutch clinical sites were prospectively collected and analyzed. Any patient suitable for implantation with Xposition S according to current recommendations was enrolled. Primary endpoint was major adverse cardiac events (MACE) at 1 year. RESULTS: Between 2015 and 2018, data from 251 patients were collected. Clinical presentation was an acute coronary syndrome in majority of the patients (76.9%). Main angiographic indications were lesions in aneurysmatic or ectatic vessels (32.3%), thrombus containing lesions (13.1%), and bifurcation/left main stenosis (10.4%). Most of the target lesions (TLs) were classified as AHA/ACC Type C (53.6%). Despite lesion complexity, device was successfully implanted at TL in 96.8%. MACE rate, reported on patients having completed 1-year follow-up (n = 203), was 6.6%, with low rate of definite/probable stent thrombosis (1.0%). CONCLUSIONS: In clinical practice of several Dutch sites, STENTYS Xposition S showed good procedural results and low 1-year clinical events rate, despite complex coronary anatomy.

Mechanical analysis of a novel biodegradable zinc alloy stent based on a degradation model.

BACKGROUND: Biodegradable stents display insufficient scaffold performance due to their poor Young's Modulus. In addition, the corresponding biodegradable materials harbor weakened structures during degradation processes. Consequently, such stents have not been extensively applied in clinical therapy. In this study, the scaffold performance of a patented stent and its ability to reshape damaged vessels during degradation process were evaluated. METHODS: A common stent was chosen as a control to assess the mechanical behavior of the patented stent. Finite element analysis was used to simulate stent deployment into a 40% stenotic vessel. A material corrosion model involving uniform and stress corrosion was implemented within the finite element framework to update the stress state following degradation. RESULTS: The results showed that radial recoiling ratio and mass loss ratio of the patented stent is 7.19% and 3.1%, respectively, which are definitely lower than those of the common stent with the corresponding values of 22.6% and 14.1%, respectively. Moreover, the patented stent displayed stronger scaffold performance in a corrosive environment and the plaque treated with patented stents had a larger and flatter lumen. CONCLUSION: Owing to its improved mechanical performance, the novel biodegradable zinc alloy stent reported here has high potential as an alternative choice in surgery.

Occurrence and predictors of acute stent recoil-A comparison between the xience prime cobalt chromium stent and the promus premier platinum chromium stent.

OBJECTIVES: To compare the occurrence of acute stent recoil in two different stent types (platinum chromium and cobalt chromium) and identify the potential predictors of significant acute stent recoil. BACKGROUND: Acute stent recoil is frequently observed after percutaneous coronary intervention and has been associated with in-stent restenosis and in-stent thrombosis. Different stent designs may result in varying degrees of stent recoil. METHODS: From a registry of "all-comers" treated with either the Xience Prime Cobalt Chromium or Promus Premier Platinum Chromium stent, a random sample of 100 patients was drawn. Acute stent recoil was defined as the minimal luminal diameter (MLD) of the last inflated balloon minus the MLD after, divided by the MLD of the last inflated balloon. Significant acute stent recoil was defined as recoil ≥10%. RESULTS: A total of 123 lesions (61 Xience Prime vs 62 Promus Premier) in 100 patients were analyzed. Acute stent recoil of 8.6 ± 4.9% was observed in the Xience Prime group versus 8.7 ± 4.2% in the Promus Premier group, P = 0.970. In a multivariate model for significant acute stent recoil, a stent/vessel ratio ≥1 (hazard ratio 4.64 [1.94-11.12], P = 0.001), a balloon/stent ratio >1 (hazard ratio 3.83 [1.12-13.14], P = 0.032) and direct stenting (hazard ratio 0.42 [0.18-0.96], P = 0.039) were identified as predictors. CONCLUSIONS: No significant differences were observed in the extent of acute stent recoil between the Xience Prime and the Promus Premier stent. A larger stent/vessel ratio, a larger balloon/stent ratio, and direct stenting were associated with significant acute stent recoil ≥10%. © 2017 Wiley Periodicals, Inc.

Double layered stents for carotid angioplasty: A meta-analysis of available clinical data.

OBJECTIVES: The objective of this meta-analysis is to evaluate clinical efficacy of double layered mesh covered carotid stent systems in the clinical practice. BACKGROUND: The need for an increase plaque coverage to decrease the risk of debris dislodgement through the stent struts, following carotid artery stenting (CAS), has brought to the design of a new generation of double layered carotid stents. Several small sized clinical studies evaluating two different devices have been recently published, unfortunately these are not sufficiently powered to test for device related and clinical endpoints and no comparison, between the two available devices, has been reported yet. METHODS: Ten studies, enrolling 635 patients, were included in the present meta-analysis. Our study analyzed a composite endpoint of 30-day stroke and death and the occurrence of procedural unsuccess after CAS with the use of two different double layered carotid stent systems. RESULTS: Thirty-day stroke and death rate was quite low (patients 635, event rate 0.02, 95% CI: 0.01-0.04, P < 0.0001). The incidence of procedural unsuccess with these devices was relatively low (patients 635, event rate 0.03, 95% CI: 0.01-0.08, P < 0.0001). When a subgroup analysis was performed, according to the specific subtype of carotid stent, no differences in the occurrence of 30-day death and stroke rate and procedural unsuccess were observed (P = 0.979). CONCLUSIONS: This meta-analysis suggests that dual layered carotid stents could be safely used for the treatment of extracranial carotid artery stenosis, with a relatively low rate of procedural unsuccess, and allow achieving a quite low rate of postprocedural adverse events.