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.

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.

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).

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.

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.

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.

A First-in-Human Evaluation of a Novel Mesh-Covered Stent for Treatment of Carotid Stenosis in Patients at High Risk for Endarterectomy: 30-Day Results of the SCAFFOLD Trial.

OBJECTIVES: The primary purpose of this study was the composite of major adverse events through 30 days post-index procedure or ipsilateral stroke from 30 days to 1 year (365 days). Presented here is the composite of death, stroke, and myocardial infarction (MI) through 30 days. BACKGROUND: Rates of minor stroke have been higher with carotid artery stenting (CAS) compared with carotid endarterectomy (CEA). The study hypothesized that a stent with mesh covering may improve plaque stabilization during CAS, reduce plaque protrusion, and lead to reduced stroke rates. METHODS: The SCAFFOLD trial, a prospective, multicenter, single-arm clinical trial evaluating the GORE carotid stent (GCS), enrolled patients at increased risk for adverse events from CEA with severe carotid artery stenosis (defined as symptomatic ≥50% or asymptomatic ≥80%). The SCAFFOLD trial screening committee was implemented to determine adherence to the study protocol. Patients were evaluated for the primary endpoint, the composite of death, stroke, and MI through 30 days. RESULTS: A total of 312 patients were enrolled, treated, and reviewed by the SCAFFOLD trial screening committee, of which 265 were included in the primary analysis population. The 30-day rate of death, stroke, or MI was 3.0% (95% confidence interval: 1.3% to 5.9%) and the stroke or death rate was 1.5%. The 30-day stroke rate was 1.1%. The 2 deaths in the study were not stroke related. CONCLUSIONS: Low death, stroke, or MI rates were demonstrated with GCS in patients at high risk for CEA. The 30-day stroke rate of 1.1% suggests that the carotid stent mesh covering may reduce the neurologic events associated with CAS when used in appropriately selected patients.

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.

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.

To neither bleed nor clot: That is the question.

Patients with atrial fibrillation (AF) when stented with thin-strut colbalt chrome stents may have a similar outcome to patients without AF. Management of patients with AF potentially place patients at enhanced bleeding risk with triple antithrombotic therapy, or potential thrombotic risk if either oral anticoagulation is held or anti-platelet therapy is truncated. Guideline-based oral anticoagulation for AF is expanding this patient group presenting to the cardiac catheterization laboratory, yet management decisions are still based on limited studies and rely on expert concensus.

Bench and initial preclinical results of a novel 8 mm diameter double opposed helical biodegradable stent.

BACKGROUND: Metallic endovascular stents are utilized off-label in congenital heart disease. Biodegradable stents (BDS) offer potential advantages in a growing child. We have previously reported double opposed helical (DH) BDS up to 6 mm diameter (DH-6). The objectives are to investigate the bench characteristics of larger 8 mm diameter BDS (DH-8) manufactured with increasing strut thicknesses and the inflammatory profile in a porcine model. METHODS: DH-8 were manufactured with strut thicknesses 0.10, 0.12, and 0.18 mm and mechanical testing performed. Stents were deployed into the infrarenal descending aorta (DAO) of nine minipigs. At insertion (nonsurvival = 2), 1 week (n = 2), 1 month (n = 2), and 9 months (n = 3) follow-up angiography, intravascular ultrasound and histopathology were performed. RESULTS: There was superior recoil and collapse pressure with increasing strut thickness, with 0.18 mm having 1.0% elastic recoil and collapse pressure 0.75 Atmospheres. There was good wall apposition at insertion with 5 BDS (4 DH-8 and 1 DH-6) but suboptimal in 4 as the minipigs infrarenal DAO were >8 mm (deployed at iliac bifurcation). Structural integrity was maintained in 8 BDS with 1 DH-8 collapsed at 9 months, secondary to strut damage at insertion. No thrombosis was seen. There was mild inflammation and neointimal proliferation at 1 week and 1 month, but a moderate inflammatory response at 9 months. CONCLUSIONS: DH-8 with increased strut thickness had acceptable mechanical properties at the cost of an increased inflammatory response. Miniaturization to improve delivery and further investigation on the long-term inflammatory profile of thicker struts, including through degradation, is needed. © 2016 Wiley Periodicals, Inc.

Stent fracture: Insights on mechanisms, treatments, and outcomes from the food and drug administration manufacturer and user facility device experience database.

OBJECTIVES: Stent fracture (SF) is an uncommon complication following percutaneous coronary intervention. Previous studies of SF have either been small single-center studies or have reported data mainly from first generation platforms. The FDA MAUDE database was used to identify cases of SF to gain mechanistic insight into procedural and anatomical factors predisposing to this complication, to define treatment and associated clinical outcomes in contemporary and first generation stent platforms. METHODS AND RESULTS: Using defined search terms, 376 unique reports of SF were identified in the FDA MAUDE database of which 336 (89.4%) occurred in first generation stent platforms with 96.1% occurring in the Cypher platform. The remaining 40 reports (10.6%) occurred with a similar distribution of cases across different contemporary platforms. Common vessel characteristics associated with SF included calcification, tortuosity, stent overlap, and significant angulation with the most common modality of presentation being in-stent restenosis or stent thrombosis. CONCLUSIONS: SF occurs most commonly in first generation Cypher stents with a similar distribution of cases across different contemporary platforms. Optimal treatment strategy remains unclear with the decision to treat and the modality of treatment utilized depending on the type and severity of SF.

Implantation and preliminary follow-up of the Bard Valeo stent in pulmonary artery stenosis.

OBJECTIVES: To evaluate the performance of the Bard Valeo stent in pulmonary artery stenoses. BACKGROUND: The premounted Valeo stent requires only 6-7 French access and can be post-dilated to 20 mm on bench testing. Although it appears ideal for implantation in pulmonary artery stenoses in children, it has been unclear whether it has sufficient radial strength to prevent vessel recoil and stent collapse. METHODS: Twelve stents were implanted in 10 patients aged 1.2-19.9 years (weight 9.9-54 kg). Implant results were assessed retrospectively. RESULTS: All implants were successful with no complications. The stent tracked easily and was readily visible on fluoroscopy. The median (range) diameter of the pulmonary artery stenosis increased from 4.9 (1.8-7.4) mm to 9 (6-10.6) mm (P ≤ 0.01), the median peak to peak systolic pressure gradient across the pulmonary artery stenosis decreased from 16 (11-66) mmHg to 6 (0-10) mmHg (P ≤ 0.01), and the right ventricle to systemic blood pressure ratio fell from 0.72 (0.54-1.1) to 0.54 (0.28-0.69) (P ≤ 0.01). Median stent recoil was 5.5 (0-21)%. Jailed side branches remained patent. Nine stents were assessed fluoroscopically on 11.5 (0-30) month follow-up. There were no stent fractures. 6 stents were not distorted, 2 had minor distortion, and 1 stent, implanted in a highly resistant lesion, had moderate distortion. CONCLUSIONS: The Valeo stent is low profile, conformable, and easy to deliver, even in small children. It has adequate radial strength to stent pulmonary artery stenoses with minimal recoil. It maintains its geometry on medium term follow up in compliant lesions. Resistant stenoses may distort the stent.