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Transcatheter heart valve technology has rapidly progressed since initial approval in the United States. There are currently two widely available transcatheter heart valve delivery systems approved in the US; however limited data exist on optimal device selection for various patient populations. This review explores the characteristics of currently approved transcatheter heart valve systems and scenarios where one valve system may be favored over others. We provide a simplified decision tree for selecting the optimal transcatheter valve system for specific patient-centered characteristics.

BACKGROUND The impact of balloon post-dilatation (BPD) on short- and long-term valve performance after Sapien 3 (S3) implantation is unknown. This study aimed to evaluate the impact of balloon post-dilatation (BPD) on short- and long-term valve performance after the implantation of S3. METHODS A total of 846 patients implanted with S3 from the OCEAN-TAVI registry were included in this study. The patients were divided into BPD and non-BPD groups. The clinical outcomes and valve functions were compared. RESULTS The BPD group included 173 (20.4%) patients and the non-BPD group comprised 673 (79.6%) patients. The prosthesis-patient mismatch (PPM) rates were significantly lower in the BPD group than in the non-BPD group before and after propensity score matching at in-hospital follow-up (before matching: 12 [7.1%] vs. 108 [16.3%], p = 0.002; after matching: 8 [6.3%] vs. 19 [14.8%], p = 0.027) and at 1-year follow-up (before matching: 14 [12.5%] vs. 112 [23.6%], p = 0.010; after matching: 9 [10.5%] vs. 19 [22.1%], p = 0.039). The rates of acute kidney injury, cardiac tamponade, and in-hospital cardiovascular death were significantly higher in the BPD group than in the non-BPD group (acute kidney injury: 22 [12.7%] vs. 33 [4.9%], p < 0.001; cardiac tamponade: 3 [1.7%] vs. 2 [0.3%], p = 0.028; in-hospital cardiovascular death: 4 [2.3%] vs. 3 [0.4%], p = 0.016). After matching, these clinical outcomes were similar between the BPD and non-BPD groups. CONCLUSIONS The BPD group demonstrated better short- and long-term valve performance. Caution is needed to avoid procedure-related complications in patients undergoing BPD.

In the present article, we present our first experiences with a new type of balloon-expandable Myval valve (Meril Life Sciences, Gujarat, India).A total of 25 consecutive patients who underwent transcatheter aortic valve implantation (TAVI) from June 2020 to November 2020 were included in the study.The mean age of the study population was 83 (75-87) years; 17 (68%) were female, and 20 (80%) had hypertension. The Society of Thoracic Surgeons (STS) score of the group was 5.4% ± 3.5%. TAVI was performed via the transfemoral route on all patients. In 19 (76%) cases, we started the procedure without predilation. In two (10.5%) cases performed without predilation, the prosthesis did not pass the native valve. We had to implant the valve from the descending aorta in one (4%) patient. We used Prostar XL (Abbott Vascular, Santa Clara, CA, USA) for six (24%) patients and ProGlide (Abbott Vascular) for 19 (76%) patients for vascular closure. Two (8%) in-hospital deaths occurred in our study but there were no deaths in the 30-day and 90-day follow-up. Vascular complications were observed in one (4%) patient. None of the patients in our study had severe paravalvular leak (PVL), while two (8%) patients had moderate PVL. A permanent pacemaker (PPM) was required in two (8%) patients for the indication of complete atrioventricular block. The mean hospital stay for the whole group was 4 (3-7) days.Based on our experiences, the new balloon-expandable valve Myval is easy to use, efficient, and has only a few negligible drawbacks such as the need for predilation of the sheath. While shaft flexibility may have advantages in some situations including in very tortuous arteries, it may cause some difficulties in alignment of the valves.HINTERGRUND: Im vorliegenden Beitrag werden erste Erfahrungen mit einem neuen Typ ballonexpandierbarer Myval-Klappen (Fa. Meril Life Sciences, Vapi, Gujarat, Indien) beschrieben.Von Juni bis November 2020 wurden 25 aufeinanderfolgende Patienten in die Studie einbezogen, bei denen eine Transkatheter-Aortenklappenimplantation erfolgte.Das Durchschnittsalter der Studienpopulation betrug 83 (75–87) Jahre; davon 17 (68 %) Frauen, bei 20 Personen (80 %) bestand eine Hypertonie. Der Score gemäß Society of Thoracic Surgeons (STS) betrug für die Gruppe 5,4 % ± 3,5 %. Die Transkatheter-Aortenklappenimplantation erfolgte bei allen Patienten über einen transfemoralen Zugang. In 19 Fällen (76 %) wurde die Operation ohne Prädilatation begonnen. In 2 Fällen (10,5 %) ohne Prädilatation konnte die Prothese die natürliche Klappe nicht passieren. Daher musste die Klappe bei einem Patienten (4 %) von der Aorta descendens aus implantiert werden. Bei 6 Patienten wurde (24 %) Prostar XL (Fa. Abbott Vascular, Santa Clara, CA, USA) und bei 19 Patienten (76 %) ProGlide (Fa. Abbott Vascular) zum Gefäßverschluss verwendet. In dieser Studie kam es noch im Krankenhaus zu 2 Todesfällen (8 %), es traten jedoch keine Todesfälle während des 30-Tage- und während des 90-Tage-Follow-up auf. Gefäßkomplikationen gab es bei einem Patienten (4 %). Keiner der Patienten in dieser Studie wies ein schweres paravalvuläres Leck (PVL) auf, bei 2 Patienten (8 %) lag ein mittelgradiges PVL vor. Einen permanenten Schrittmacher benötigten 2 Patienten (8 %) für die Indikation eines kompletten atrioventrikulären Blocks. Die mittlere Krankenhausverweildauer in der Gesamtgruppe betrug 4 (3–7) Tage.Den Erfahrungen der Autoren zufolge ist die neue ballonexpandierbare Klappe Myval einfach zu verwenden, wirksam und hat nur wenige, vernachlässigbare Nachteile wie die Notwendigkeit der Prädilatation der Hülle. Zwar mag die Flexibilität des Schafts Vorteile in einigen Situationen, einschließlich stark geschlängelter Arterien, haben, doch kann dies auch Schwierigkeiten in der Ausrichtung der Klappen mit sich bringen.

The article serves to outline the beginnings of transcatheter aortic valve replacement and the pivotal trials that have resulted in this technology's being adopted in a widespread manner. Also detailed in the article are the differences between the various iterations of the balloon-expandable transcatheter heart valve platforms, offering insight into scenarios when a balloon-expandable or a self-expanding prosthesis might be considered based on patient characteristics.

Bicuspid aortic valve (BAV) remains challenging in transcatheter aortic valve replacement (TAVR) because of unfavorable anatomy. New-generation balloon-expandable valve (BEV) appears to be a valid alternative to surgery, especially in some Asian countries with a higher prevalence of BAV. This tutorial review summarizes current thinking about how to plan and implant BEV in BAVs using versatile techniques. First, the authors depict the main morphological characteristics of BAVs and their effects on the TAVR procedure. Next, the authors provide preprocedural analysis on sizing, obtaining the optimal deployment projection, and how to simplify valve-crossing. Finally, the authors provide step-by-step guidance on how to deploy the BEVs with evolved iterations in terms of specific anatomies, calcified annulus, and giant annulus.

Stenting is the most common intervention for arteriosclerosis treatment; however, the success of the treatment depends on the incidence of in-stent restenosis (ISR). Stent deployment characteristics are major influencers of ISR and can be measured in terms of dogboning, asymmetry, and foreshortening. This study aimed to analyse the implications of balloon and stent-catheter assembly parameters on the stent deployment characteristics. Experimental approach to analyse the impact of the balloon and stent-catheter assembly parameters on stent deployment characteristics is a time-consuming and complex task, whereas numerical methods prove to be quick, efficient, and reliable. In this study, eleven finite element models were employed to analyse non-uniform balloon stent expansion pattern, comprised of variation in, stent axial position on balloon, balloon length, balloon folding pattern, and balloon wall thickness. Obtained results suggest that the axially noncentral position of the stent on balloon and variable balloon thickness lead to non-uniform stent deployment pattern. Also, it was proved that variation in balloon length and balloon folding pattern influence deployment process. Improved positional accuracies, uniform balloon wall thickness, and selection of the appropriate length of a balloon for selected stent configuration will help to minimize dogboning, asymmetry, and foreshortening during non-uniform stent expansion, thereby reducing the risk of restenosis. The stated numerical approach will be helpful to optimize stent catheter assembly parameters thus minimizing in-vitro tests and product development time.

The next generation SAPIEN 3 Ultra (Edwards Lifesciences, CA, USA) builds on the success of the SAPIEN 3 (S3) transcatheter heart valve. The textured polyethylene terephthalate external skirt is 40% taller than the S3 valve skirt. The Edwards Commander delivery system and Edwards eSheath remain unchanged from S3 with proven results regarding valve deliverability and low rates of vascular complications.

The comparative mid and long-term durability, including the rates of bioprosthetic valve failure (BVF) of the Sapien XTConsecutive intermediate-risk patients with severe aortic stenosis from the Mexican registry of transcatheter aortic valve replacement (TAVR) with SapienDuring 2014-2019, 115 (60 Sapien XTThe BVF rate at 25 months of follow-up was similar with the XT and S3 systems. During this follow-up period, the major composite events of death from any cause and neurological events were significantly lower with the S3 system.

Small balloon expandable valves have higher echocardiographic transvalvular gradients and rates of prosthesis-patient mismatch (PPM) compared to larger valves. However, the impact of these echocardiographic findings on clinical outcomes is unknown. We sought to determine the clinical outcomes of 20 mm SAPIEN 3 (S3 BEV) compared to larger S3 BEV in relation to echocardiographic hemodynamics.Using the STS/ACC transcatheter valve registry, we performed a propensity-matched comparison of patients undergoing treatment of native aortic valve stenosis using transfemoral, balloon-expandable implantation of 20 mm and ≥ 23 mm S3 BEVs. Baseline and procedure characteristics, echocardiographic variables and survival were analyzed. Multivariable logistic regression was used to identify predictors of 1-year mortality.After propensity matching of the 20 mm and ≥ 23 mm SAPIEN 3 valves, 3,931 pairs with comparable baseline characteristics were identified. Small valves were associated with significantly higher echocardiographic gradients at discharge (15.7 ± 7.1 mmHg vs. 11.7 ± 5.5 mmHg, p 0.0001) and severe PPM rates (21.5% vs. 9.7%, p 0.0001). There was no significant difference in 1-year all-cause mortality (20 mm: 13.0% vs. ≥23 mm: 12.7%, p = 0.72) or other major adverse event rates and outcomes between the two cohorts. Based on a multivariable analysis, elevated discharge mean gradient (20 mmHg), severe PPM and the use of 20 mm versus ≥23 mm were not independent predictors of 1-year mortality.SAPIEN 3 20 mm valves were associated with higher echocardiographic gradients, and severe PPM rates compared to larger valves but these factors were not associated with significant differences in 1-year all-cause mortality or rehospitalization.

The use of a Viabahn VBX endoprosthesis (W. L. Gore & Associates, Flagstaff, Ariz) to exclude chronically thrombosed inferior vena cava (IVC) filters refractory to exclusion with self-expanding stents was evaluated. The mean duration of TrapEase IVC (Cordis, Milpitas, Calif) implantation was 7.6 years (range, 2-11 years). Symptoms included leg pain, edema, color changes, and back pain. The mean Villalta score and venous clinical severity score were 17 (range, 13-23) and 13 (range, 11-15), respectively. Indirect ultrasound evidence of stent patency was demonstrated at a mean of 8 months after intervention. The mean Villalta score and venous clinical severity score had decreased by 13 and 10, respectively, at a mean of 9.5 months after intervention. Iliocaval reconstruction with Viabahn VBX balloon expandable stent-graft exclusion of chronically thrombosed TrapEase IVC filters is safe, with favorable short-term results.

OBJECTIVES To compare clinical outcomes of balloon-expandable (BE) and self-expanding (SE) transcatheter aortic valves (TAVs) up to 5 years. BACKGROUND To date, no robust, comparative data of BE and SE TAVs at long-term are available. METHODS We considered a total of 1,440 patients enrolled in the multicenter OBSERVANT study and undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI) with either supra-annular SE (n = 830, 57.6%) and intra-annular BE (n = 610, 42.4%) valves. Clinical outcomes of the two groups were compared after adjustment using inverse probability of treatment weighting (IPTW) and confirmed by sensitivity analysis with propensity score matching. RESULTS Patients receiving SE valve showed a higher all-cause mortality at 5 years (Kaplan-Meier estimates 52.3% vs. 47.7%; Hazard ratio [HR] 1.18, 95% confidence interval [CI] 1.01-1.38, p = .04). Landmark analyses showed that there was a not statistically significant reversal of risk excess against the BE group starting from 3 years after TAVI (3-5 years HR 0.97, 95% CI 0.76-1.25, p = .86). Post-procedural, moderate/severe paravalvular regurgitation (PVR)(HR 1.46, 95% CI 1.14-1.87; p

AIMS The aim of this study was to report the predictors and clinical impact of transcatheter heart valve (THV) thrombosis in patients undergoing transcatheter mitral valve implantation (TMVI). METHODS AND RESULTS We included 130 patients who consecutively underwent TMVI. Transoesophageal echocardiography (TOE) and/or computed tomography (CT) were performed in 91.7% of patients at discharge, in 73.3% at three months and in 72% beyond three months. THV thrombosis was defined as the presence of at least one thickened leaflet with restricted motion confirmed by TOE or contrast CT and classified as immediate, early, or late according to the timing of diagnosis. THV thrombosis was observed in 16 (12.3%) patients: immediate in 43.7%, early in 37.5% and late in 18.8%. Most of these thromboses were subclinical (93.7%) and non-obstructive (87.5%). No thromboembolic event occurred. After optimisation of antithrombotic treatment, THV thromboses resolved in all but one patient. Predictors were shock for immediate (p

The transcatheter tricuspid valve-in-valve implantation has not yet been clarified, and several case series have documented results in patients with tricuspid bioprosthetic valve degeneration who underwent transcatheter implantation of Edwards SAPIEN XT and SAPIEN 3 (Edwards Lifesciences, Irvine, CA) and Medtronic (Minneapolis, MN) valves. Here, we present the case of a patient with severe bioprosthetic tricuspid valve stenosis who was successfully treated with the transfemoral route through the 29-mm novel balloon expandable Myval transcatheter heart valve (Meril Life Sciences Pvt Ltd, Vapi, Gujarat, India) system.

A 75-year-old male with severe symptomatic aortic stenosis underwent transcatheter aortic valve implantation with a Large (27-mm) ACURATE-neo transcatheter aortic valve, complicated by severe paravalvular leak. He developed rapid and progressive worsening heart failure. Reanalysis of the computed tomography images suggested evidence of prosthesis–annulus mismatch. Therefore, a redo transcatheter aortic valve implantation utilizing a 29-mm SAPIEN 3 transcatheter aortic valve was performed. This case illustrates the importance of proper valve sizing to avoid paravalvular leak, and how to safely cross an ACURATE-neo valve to avoid catheter entangling. Résumé: Un homme de 75 ans présentant une sténose aortique symptomatique sévère a subi l'implantation d'une valve aortique par cathéter, dont une ACURATE neo de 27-mm compliquée par une fuite paravalvulaire sévère. Par la suite, le patient a présenté une insuffisance cardiaque sévère . Une nouvelle analyse de ses examens tomodensitométriques a indiqué des signes d'incompatibilité entre la prothèse et l'anneau mitral. Il a donc fallu réaliser une nouvelle implantation valvulaire aortique par cathéter avec une valve SAPIEN 3 de 29 mm. Ce cas illustre l'importance d'une bonne évaluation de l'anneau valvulaire pour éviter les fuites paravalvulaires, et décrit comment traverser une valve ACURATE neo pour éviter l'enchevêtrement du cathéter.

Bicuspid aortic valve (BAV) patients are usually excluded from transcatheter aortic valve implantation (TAVI) as this valve anatomy likely leads to oval expansion. This study presents a numerical study of TAVI using both self-expanding and balloon expandable transcatheter heart valve (THV) in bicuspid patients with severe stenosis. The simulation framework included a patient-specific anatomy of the aortic root, calcifications and BAV leaflets extracted from medical imaging analysis as well as a realistic crimping and deployment of the THV. Tissue stress analysis highlighted local maxima in the contact area between the inner aortic lumen and the THV stent frame. Flow analysis based on the smoothed particle hydrodynamics (SPH) technique displayed the area at risk of paravalvular leakage (PVL). These findings provide insights on the TAVI in BAV and thus represents a further step towards the use of in-silico for the virtual planning of TAVI, aiming at improving not only the efficacy of the implantation but also the exploration of borderline anatomy as the case of TAVI in BAVs.

Introduction: Transfemoral access (TF) is the preferred access for transcatheter aortic valve implantation (TAVI). Transcarotid TAVI (TC-TAVI) is an alternative for patients in whom TF-TAVI is impossible. Two types of valves - balloon-expandable (BE) and self-expandable (SE) - can be used in TC-TAVI procedures. Aim: Comparison of the short-term results of patients treated with TC-TAVI using BE and SE valves. Material and methods: The retrospective registry included 39 patients in whom the TC-TAVI procedure was performed between 2017 and 2020 (BE-TAVI; n = 10, SE-TAVI; n = 29). Preoperative characteristics, operative and postoperative results, and 30-days mortality were compared. Results: Patients from the BE-TAVI group had higher surgical risk (EuroSCORE) (10.8% (6.2-14.0) vs. 5.5% (4.3-8.7); p = 0.027). The incidence of chronic obstructive pulmonary disease (COPD) was higher in the SE-TAVI group (34.5% vs. 0%; p = 0.040). In terms of other comorbidities, demographics, preprocedural laboratory results, transthoracic echocardiography (TTE), and multislice computed tomography (MSCT), the two groups were comparable. In both groups, we observed 100% procedural success. The median valve size was larger in the SE-TAVI group (29.0 (26.0-29.0) vs. 26.0 (23.0-26.0); p < 0.001). The hospitalization time was shorter in the BE-TAVI group vs. SE-TAVI (5.8 ±0.6 vs. 6.4 ±0.9; p = 0.043). We did not observe statistically significant differences between BE-TAVI and SE-TAVI in periprocedural and 30-day mortality, or the number of strokes/TIA. Also TTE parameters and NYHA class showed similar improvement at 30 days in both groups. Conclusions: TC-TAVI using balloon-expandable and self-expandable valves showed similar safety and efficacy in 30 days follow-up.

Objective: We report carotid artery stenting (CAS) using balloon-expandable coronary (BECo) stent. The materials in this study consist of 15 cases of high-grade stenosis in internal carotid artery (ICA) in which self-expanding carotid (SECa) stent was not utilized. There were two groups why BECo stent was used instead of SECa stent: alternative group and intentional group. The alternative group was subdivided into two groups: access difficulty of guiding catheter and access difficulty of SECa stent. Case Presentation: The alternative group included 11 cases (access difficulty of guiding catheter in 10 and access difficulty of SECa stent in 1), and the intentional group included 4 cases. There were four cases using transbrachial approach. All the intentional group cases were the first stage of staged angioplasty (SAP). The second stage of SAP was PTA in two and SECa stent over the BECo stent in two. There was no complication related to CAS. Conclusion: CAS using BECo stent is one of the choices for the first stage of SAP, if stent placement instead of PTA is required at the first stage. It is also the useful alternative for the patient having difficulty of SECa stent.

Objectives:We report our experience of using the Bentley BeGraft Aortic stent in patients with severe or near-atretic aortic coarctation and small femoral arterial access.Background:Use of covered stent is recommended in some settings such as aortic coarctation with associated aneurysm, Turner syndrome, and coarctation with aortic atresia. However, currently available covered stents need larger sheaths that may limit their use in children and patients with smaller arterial access. Newer stents may overcome this limitation.Methods:Single-centre retrospective study of patients with severe or near-atretic aortic coarctation and small femoral arterial access.Results:Between July and October, 2019, five patients (median age 15 years) with near-atretic or severe coarctation were treated with a Bentley BeGraft Aortic stent. Long sheaths between 9 and 11 Fr were used to implant stents, which were dilated up to 12–16 mm. None of the patients had residual coarctation (gradient >20 mm of mercury) after stenting. None of the patients developed acute vascular injuries or local access related complications at the end of the procedure or during follow-up (range 6–10 months).Conclusions:Bentley BeGraft aortic stents are important to consider in patients with severe coarctation and provided acute procedural success in patients with small femoral arterial access and widen the applicability in this patient population.

Aim is to report on the results of an optimized balloon filling algorithm and suggest a refinement of the implantation approach to maximize safety. Appropriate sizing of balloon expandable valves during transcatheter aortic valve implantation is crucial. Study comprised 370 consecutive patients receiving SAPIEN 3 valve between 2015 and 2018. Valve expansion/recoil measurement in the inflow area, annular area, and outflow area was performed previously and postimplantation. Nominal balloon filling resulted in underexpansion-23 mm (20.96 mm), 26 mm (23.88 mm), and 29 mm (27.56 mm) SAPIEN 3 valves at the annular level. Increased balloon filling by 2 cc resulted in a gradual increase in valve diameter reaching 97.35% (23 mm), 96.50% (26 mm), and 96.11% (29 mm) of the nominal valve diameter. Final diameters were usually higher in the valvular inflow and outflow tracts. The 29 mm valve did not reach its nominal diameter with 2 cc overfilling and in none of inflow area (95.48%), annular area (96.11%), or outflow area (96.86%). Device success (by VARC II) was 96.2%. No root or septal rupture, device migration, mitral valve injury, coronary obstruction, or dissection occurred. Rate of new permanent pacemaker implantation was 8.3%. Paravalvular leakage was none or trace in most patients. Mean valve gradient was 10.77 mm Hg postprocedure. 1.9% of the patients had a maximum gradient of >40 mm Hg, 2.2% >20 mm Hg. In conclusion, an optimized balloon filling algorithm resulted in appropriate valve gradients, low levels of paravalvular leakage, low rates of permanent pacemaker implantation and no annular rupture.

Even mild paravalvular leak (PVL) is associated with worse quality of life and increased mortality. The Ultra transcatheter heart valve (THV) is intentionally designed to reduce PVL. However, there...

Objectives The aim of this study was to compare outcomes after transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 Ultra (Ultra) and SAPIEN 3 (S3) transcatheter heart valves (T...

Purpose: In endovascular aneurysm repair, parallel stent graft deployment is sometimes utilized to preserve the distal branch perfusion. However, there will be some gutter space around 2 stent grafts, which may cause endoleak. The “eye of the tiger” technique was invented to minimize this leak when deploying a small side-branch stent graft in conjunction with a large aortic endograft. The purpose of this case report is to describe our modified technique for 2 small endografts deployed in double D-shape in order to prevent gutter leak, which we applied in endovascular treatment for a hypogastric artery aneurysm. Case Report: A 79-year-old male patient presented with a right hypogastric artery aneurysm measuring 44 mm. The patient refused the open surgical repair option and hoped for an endovascular treatment. Therefore, endovascular treatment to exclude the hypogastric artery aneurysm as well as preserve the gluteal arteries was planned. An Internal Iliac Component (IIC)(W. L. Gore & Associates, Flagstaff, AZ, USA) was utilized for the proximal sealing and 2 Viabahn stent grafts (W. L. Gore & Associates) were deployed in the superior and inferior gluteal arteries for distal sealing. Then, 2 VBX stent grafts (W. L. Gore & Associates) were added in the IIC as bridging stents to connect the IIC and both Viabahn stent grafts. Next, over-dilatation of VBX stent grafts was performed alternately with an 8 mm balloon catheter and subsequent kissing balloon dilation with 5 mm balloon catheters, which allowed the VBX stents to be set in double D-shape. A follow-up CT scan performed 1 week after the procedure revealed no endoleak and a favorable shape to the VBX stent grafts. Conclusion: The modified method of dilating the VBX stent grafts allowed the double D-shape deployment, minimizing the risk of gutter leak and preserving distal branch perfusion.

During the implantation process, an expandable balloon stent undergoes a change in mesh shape with a high strain rate. Permanent mesh shape changes to the stents indicate plastic deformation has occurred. On a micro-scale, plastic deformation has significant influence when interacting with the soft tissue of human blood vessels. This experimental study aims to investigate the effect of surface treatment and cutting orientation on the changes in surface roughness that definitely occurs when a stent deployed. To study the effect of surface treatment, two types of surface treatment were applied after surface polishing, i.e. etching and electropolishing. Surface polishing is carried out to enable microscopic observation. As for examining the effect of cutting orientation, the plate is cut in lateral and longitudinal orientation against the predicted-rolling direction of 316L sheet-type of stainless steel. An intermittent tensile test is conducted to obtain information about the changes in surface roughness. The surface observation is carried out three times on a similar surface of testpiece after reaching plastic deformation. The experimental study shows that the orientation of raw material has an insignificant effect on the changes in stent surface roughness. As for the surface treatments, electropolishing tended to decrease the tensile property of material.

Endovascular interventions are being increasingly used around the world. They are accepted as the primary approach to aortoiliac occlusive disease in most cases. Mainly, balloon-expandable stents are utilized to treat lesions, and some patients may develop complications. Stents may thrombose or migrate due to the force of the bloodstream or their inappropriate dimensions. Sometimes, the operator is to blame. We herein describe a 67-year-old patient with a history of multiple endovascular interventions presenting to the emergency department with right foot pain. The patient underwent repeated angiography and endovascular intervention. In the last approach, diagnostic angiography revealed a crushed and migrated balloon-expandable stent in the abdominal aorta. The stent was removed surgically, and aorta-femoral bypass grafting was performed. Endovascular maneuvers could lead to these complications; hence, the operator should exercise caution when working on previously implanted stents. Optimal stent expansion and awareness of this very uncommon complication are essential.

Coarctation of aorta is commonly treated with endovascular interventions such as coarctation stenting. Migration of stent is the most dreaded complication of coarctation stenting. A 60-year-old lady with severe malaligned coarctation underwent endovascular stent placement. The expanded stent migrated to proximal aorta, which could be stabilized with a bioptome, re-positioned with a balloon and postdilated to its optimal size, resulting in a good outcome.

Given the rarity of splenic vein aneurysms, it is no surprise that there are little data to help guide clinicians regarding indications and techniques for repair. Traditionally associated with hepatobiliary pathology including portal hypertension and pancreatitis, management typically involved open splenectomy. We describe the case of a patient with an incidentally found enlarging splenic vein aneurysm in the absence of significant past medical history. The patient underwent successful repair of the aneurysm utilizing a transhepatic endovascular approach with a balloon expandable stent. We offer this as minimally invasive solution allowing splenic salvage.

Sutureless aortic bioprostheses were introduced more than ten years ago, with the aim of decreasing cross-clamp time and thus becoming the first choice in older patients for many surgeons. However, published data are limited to a 5-year follow-up, and some cases of deterioration have already been described. High-risk patients who once have benefitted from a fast sutureless aortic replacement and now are experiencing a prosthesis dysfunction, could take advantage of a percutaneous Valve-in-Sutureless technique. Furthermore, thanks to technological improvement, new transcatheter prostheses have been designed, allowing a more precise positioning. In this report, we described the first Myval-in-Perceval case, which resulted in a safe and effective procedure.

Transcatheter stent deployment is an effective, yet high-risk intervention in pulmonary artery (PA) stenosis, associated with vascular injury and airway hemorrhage. In the US, the only covered sten...

Objectives Endovascular therapy using balloon expandable stents has become the treatment standard for most iliac atherosclerotic lesions. We aimed to assess the safety and performance of the Dynamic stainless-steel balloon-expanding stent system in this location. Methods BIODYNAMIC is a retrospective single center study including consecutive patients with iliac lesions treated with the Dynamic stent system. Not included were implantations inside an endograft. The primary endpoint was freedom from major adverse limb events (MALE) at 12 months, defined as index limb amputation or target lesion revascularization (TLR). Secondary endpoints were procedure success, ankle brachial index (ABI) and Rutherford class change, mortality and freedom from TLR after 12 months. Results Within two years, 182 patients with 234 lesions in the common iliac artery were enrolled. Rutherford class 5 and 6 were present in 11.5% of patients, average stent diameter was 8.0 ± 0.5 mm and stented length 40.0 ± 15.3 mm. The primary endpoint was reached in 96.2% (225/234) of the cases, with six TLR (2.6%) and three target limb amputations (1.3%). Procedure success was obtained in all but three patients (98.4%). In paired analysis, ABI improved by 0.25 ± 0.21 from baseline to 0.90 ± 0.16 post-procedure and Rutherford class improved by −1.75 ± 1.53. There were four non-device–related deaths (2.2%). Freedom from TLR was 97%, 95.3%, 94% and 92.7% at 24, 36, 48 and 60 months, respectively. Conclusion The Dynamic balloon-expandable stent system proved to be safe and effective in a population with common iliac artery lesions.

The purpose of the study is to perform a postimplantation geometrical analysis and to evaluate early and mid-term outcomes of new-generation balloon-expandable covered stents, used in the kissing conformation to treat obstructive lesions involving the aortic bifurcation.A single-center retrospective review of all patients who underwent endovascular reconstruction of the aortoiliac bifurcation for obstructive disease, with the use of Viabahn balloon expandable stents (VBX; W. L. GoreAssociates, Flagstaff, AZ) deployed in the kissing conformation, from March 2018 to June 2019 was carried out. Two same-size kissing VBXs were simultaneously deployed from the distal aorta (1.5-2 cm above the aortic bifurcation) to the common iliac arteries; a kissing post-ballooning using compliant balloons was routinely performed to flare the proximal part of the VBX, to adapt to the aortic diameter and morphology. A postoperative computed tomography (CT) angiogram was obtained for all patients for the geometrical assessment. "Precision" of deployment was measured as protrusion mismatch, intended as the longitudinal distance between the stents' proximal ends. "Conformability" was measured as radial mismatch (area and volume of the "dead space" between the stented lumen and the aortic wall) and D-ratio (ratio of the major and minor axes in the axial view). Symmetry was measured as the ratio between the minor diameter of the 2 kissing stents at the same level.Twenty-eight patients (56 limbs) underwent endovascular treatment with kissing VBXs for Trans-Atlantic Inter-Society Consensus II C (n = 10, 36%) or D (n = 18, 64%) lesions involving the aortic bifurcation. Two 8-mm diameter ("8L") VBX stents were used in most cases (n = 32, 57%). At the postoperative CT, the mean protrusion mismatch was 0.8 ± 1.7 mm and was5 mm in all cases. The mean radial mismatch area was 20.4 ± 10.6 mmThe use of kissing VBX stents may represent a valid option for the treatment of obstructive lesions involving the aortic bifurcation, with excellent early and mid-term outcomes and achievement of optimal stents geometry.

RESUMO O implante transcateter de valvula aortica e uma das principais estrategias de tratamento da estenose aortica grave sintomatica. Estudos recentes embasaram a expansao das indicacoes para pacientes com baixo risco cirurgico. Nesse contexto, espera-se que uma populacao mais jovem e portadora de valvulas aorticas bicuspides seja mais frequentemente submetida a terapia valvar transcateter, pois esse perfil de anatomia esta em geral associado a aneis aorticos de maiores dimensoes. Nao ha consenso sobre a melhor tecnica a ser empregada nesses [...]

Aortic valve calcification severity has been associated with higher rates of aortic regurgitation (AR) following TAVR, but scarce data exist on its impact with the use of newer generation transcatheter heart valves.This was a multicenter study including 626 patients with severe aortic stenosis who underwent TAVR with the SAPIEN 3 valve. Patients were divided in 2 groups according to the median index calcium score (iCS) for each sex: high CS (HCS, iCS ≥ median), and low iCS (LCS, iCS median). Another analysis was performed in those patients with extreme iCS (ECS, iCS75th percentile for each sex). Clinical and echocardiographic data were collected prospectively in a dedicated database.The mean CS was 3758 ± 1417 AU and 1616 ± 691 AU in the HCS and LCS groups, respectively (p 0.001). There were no differences between groups in 30-day mortality (HCS:2.6%, LCS:1.0%, p = 0.13) and stroke (HCS:2.6%,LCS:2.6%, p = 1.0) rates, but all cases (n = 5) of annulus rupture occurred in the HCS group (1.6% vs. 0%, p = 0.061). The incidence of moderate-severe AR post-TAVR was low in both groups (HCS:1.6%,LCS:1.6%, p = 1.0), and valve gradient and area were similar between groups. The results remained similar in the ECS group (mean CS:4607 ± 1424 AU), but a mildly increased mean transvalvular gradient post-TAVR was observed in ECS patients (12.1 ± 5.6 vs 11.0 ± 4.3 mmHg; p = 0.015).Aortic valve calcification severity failed to impact mortality/stroke rates following TAVR with the SAPIEN 3 valve. Low rates of significant AR were observed irrespective of CS, and a mild increase in transvalvular gradient was observed in ECS patients.

Purpose: To assess the midterm safety and effectiveness of the Gore Viabahn Balloon-Expandable Endoprosthesis (VBX Stent-Graft) in the treatment of patients with de novo or restenotic aortoiliac lesions. Materials and Methods: The prospective, multicenter, nonrandomized, single-arm VBX FLEX clinical study ( ClinicalTrials.gov identifier: NCT02080871) evaluated 134 patients (mean age 66±9.5 years; 79 men) up to 3 years after treatment with the VBX Stent-Graft. A total of 213 lesions were treated with 234 stent-grafts. The primary safety endpoint was a composite of major adverse events (MAEs), which were evaluated through 30 days and 9 months. Secondary outcomes collected through 3 years included freedom from target lesion revascularization (TLR), target vessel revascularization (TVR), clinically-driven TLR (CD-TLR), and CD-TVR as well as Rutherford category, resting ankle-brachial index (ABI), and functional status. A univariate analysis determined any correlation between baseline variables and TLR. Results: The observed composite percentage of MAEs was 2.3%, well below the 17% performance goal (pConclusion: The VBX Stent-Graft is a robust and durable treatment option for aortoiliac occlusive disease as evidenced by the sustained 3-year safety and effectiveness outcomes.

Purpose: To assess in silicone juxtarenal aneurysm models the gutter characteristics and compression of different types of chimney graft (CG) configurations. Materials and Methods: Fifty-seven combinations of Excluder C3 or Conformable Excluder stent-grafts (23, 26, and 28.5 mm) were deployed in 2 silicone juxtarenal aneurysm models with 3 types of CGs: Viabahn self-expanding (VSE; 6 and 13 mm) or Viabahn balloon-expandable (VBX; 6, 10, and 12 mm) stent-grafts and Advanta V12 balloon-expandable stent-grafts (ABX; 6 and 12 mm). Setups were divided into 4 groups on the basis of increasing CG and main graft (MG) diameters. Two independent observers assessed gutter size and type as well as CG compression on computed tomography scans using postprocessing software. Results: In the smaller diameter combinations (6-mm CG and 23-, 26-, and 28.5-mm MGs), both VSE (p=0.006 to 0.050) and ABX (p=0.045 to 0.050) showed lower gutter areas and volumes compared with VBX. In turn, the VBX showed a nonsignificant tendency to decreased compression, especially compared to ABX. Use of the Excluder C3 showed a 6-fold increase in type A1 gutters (related to type Ia endoleak) as compared to the Conformable Excluder (p=0.018). Balloon-expandable stent-grafts (both ABX and VBX) showed a 3-fold increase in type A1 gutters in comparison with self-expanding stent-grafts (p=0.008). Conclusion: The current study suggests that use of the Conformable Excluder in combination with VSE chimney grafts is superior to the other tested CG/MG combinations in terms of gutter size, gutter type, and CG compression.

Stenting of curved arteries is more challenging than straight vessels. There has been an increasing need for new techniques to treat lesions in highly curved locations. One generic idea is to use curved stents to treat lesions in such curved locations. Computational modeling of straight stent crimping which is being used to evaluate the structural performance of the stents has been done vastly in the past. However, there has not been much simulation work on crimping of curved stents due to the challenges associated with applying the boundary conditions. Here we propose a new method to crimp a curved stent to a smaller diameter by incorporating a simple algorithm to generate the required boundary conditions supplementing the finite element (FE) code. To achieve this, a curved crimper is modeled and used to apply crimping loading on the curved stent evaluate its crimpability. Our method provides a simple yet very useful tool which can be implemented in finite element packages to simulate crimping of curved stents using curved crimpers. This method can also be used to expand balloon expandable stents by inflating curved balloons.

Objectives To expand on the limited available literature regarding the use of balloon expandable covered stents for the treatment of traumatic aortic injuries (TAI) in the pediatric population. Background Although endovascular grafts have largely replaced surgery for TAI repair, there are significant limitations to the use of these grafts in pediatric patients. Methods Multicenter, retrospective chart review of pediatric patients with TAI following blunt chest wall trauma. Procedural characteristics, follow-up, and reinterventions are described. Results Six covered stents implanted in five patients. Median patient age was 12 years (11-13 years) and median weight 50 kg (44-54 kg). Procedural success was achieved in all cases. No procedural or postprocedural complications were noted. Median follow-up time was 24 months (11-36 months). Conclusions Balloon expandable covered stent treatment of pediatric patients with TAI is a feasible alternative to open surgical repair, and preferred over endovascular grafts due to graft size limitations and the large delivery systems.

Atherosclerosis is one of the major types of cardiovascular diseases. Stent deployment into the stenosed artery is the most common treatment for atherosclerosis. Two common stent models based on two different expansion principles are balloon-expandable and self-expandable stents. Depending on the modality of the expansion, the material used for these two stents varies. Despite the extensive progress made in the field of stent construction, plaque fragmentation and in-stent restenosis are two of the problems that still cause complications in stenting. Computational modeling and finite element method help us predict the damage effects to the artery and plaque in the stenting process. In this article, we simulate the insertion of two stents (the stainless steel stent and the shape memory alloy stent) in a diseased artery with real geometry. Results are compared to account for the effects of these stents on the artery, especially, the maximum stress in the plaque and arterial layers and surgically induced damage as the main cause of plaque fracture during the stent deployment and in-stent restenosis. It is found that arising from superelasticity, the shape memory alloy stent induces less damage to the artery. In addition, the stress created in the artery by the shape memory alloy stent is smaller. Therefore, the risk of plaque fragmentation and in-stent restenosis is reduced in shape memory alloy stents.

Background Covered stent has become one of the mainstream therapies for aortoiliac obstructive disease (AIOD), with higher patency rate compared to bare metal stent. Covered balloon-expandable (CBE) stent can be placed more accurately with higher radial support force, while covered self-expanding (CSE) stent has greater elasticity and higher trackability. However, there is no level I evidence regarding the comparison safety and efficacy between the CSE stent and CBE stent in AIOD up to date. Therefore, this study aims to compare the efficacy and safety of CBE stent (BARD®LIFESTR`EAM™) and CSE stent (GORE® VIABAHN™) in AIOD. Methods This trial is a prospective, single center, paralleled, non-inferiority, randomized controlled trial. A total of 106 patients will be enrolled and these patients will be randomized to either the CBE stent group or CSE stent group. The primary end point of the study is occurrence of Target Lesion Revascularization (TLR) at 12 months after the intervention. Discussion To our knowledge, the NEONATAL trial is the first RCT to compare CBE and CSE stent in AIOD patients. The results of clinical trials may contribute to establishing a strategic guideline for choosing the optimal type of covered stent in treatment of AIOD patients. Trial registration: ChiCTR2100046734; Registered on 27 May, 2021 in Chinese Clinical Trials Registry.

Jennifer Wong, Elliot Backer, Joseph C Keenan, Huseyin Erhan Dincer, Roy Joseph Cho Interventional Pulmonology Division, Department of Pulmonary, Allergy, Critical Care and Sleep Medicine, University of Minnesota, Minneapolis, MN, USACorrespondence: Roy Joseph Cho Tel +1 612-626-2637Email choxx548@umn.eduPurpose: Balloon-expandable stents are commonly used for the treatment of tracheobronchial strictures. We routinely perform targeted overdilation of these stents 1– 2mm on initial deployment to prevent stent migration or allow foreshortening to target airway caliber; however, specific data on the effect of targeted overdilation is unknown.Patients and Methods: We used three iCAST stents (6× 22mm, 7× 22mm, and 10× 38mm) to perform the study. We had two sets of each size to average our results. Targeted overdilation was accomplished with Merit Elation balloons.Results: The 6 × 22 and 7 × 22 stent OD increased from 6 to 11.4mm and 7 to 11.6mm. The 10 × 38 stent demonstrated minimal OD change with overdilation (OD change of 10.4 to 12.2mm). All stents demonstrated significant foreshortening with overdilation (20.2 to 5.65mm, 19.4 to 6mm, and 30.9 to 10.2mm for 6 × 22, 7 × 22, and 10 × 38, respectively). The breakpoint was seen at near twice the stated stent OD (13.5mm, 15mm, and 15mm with 6 × 22, 7 × 22 and 10 × 38, respectively).Conclusion: We have demonstrated that iCAST stents can increase their OD with subsequent foreshortening during targeted overdilation. This data can help facilitate decisions when selecting a particular iCAST stent for a specific airway application. Additionally, we have highlighted that balloon inflation diameter does not correspond to the actual stent OD during deployment. We believe that this data offers practical information for end-users of this stent type and additional data will be needed to corroborate our findings.Keywords: airway stenosis, tracheobronchial disease, interventional pulmonary, airway stent, balloon expandable stent, airway balloon dilation

Background/Introduction Advancements in balloon-expandable transcatheter heart valves (THV) have improved outcomes in transcatheter aortic valve implantation (TAVI). The most recent iteration, the SAPIEN 3 Ultra THV, offers a taller paravalvular skirt which has demonstrated similar short-term outcomes while reducing mild paravalvular leak in high- and intermediate-risk patients. Purpose We sought to describe a real-world experience comparing short-term outcomes in the SAPIEN 3 THV to the SAPIEN 3 Ultra THV in patients across the risk spectrum (including low-risk). Methods We conducted a retrospective, observational study of patients who underwent TAVI using either the SAPIEN 3 or SAPIEN 3 Ultra THV between 2019–2020. In-hospital, 30-day and 1-year Valve Academic Research Consortium-2–defined outcomes were examined. Results We screened a total of 457 patients who underwent TAVI at our institution between 2019–2020. Included were 254 patients who received either the SAPIEN 3 THV or the SAPIEN 3 Ultra THV. Baseline clinical characteristics were similar in both cohorts (Table 1). Procedural success was similar in both cohorts (97.2% vs. 97.3%; p=1.ehab724.1647) with similar rates of >mild paravalvular leak (7.7% vs. 10.7%; p=0.3796). Mortality and rates of stroke were extremely low and similar in both cohorts at 30 days and 1 year (Table 2). There was a trend towards lower rates of permanent pacemaker implantation in the SAPIEN 3 Ultra cohort (In-Hospital: 9.2% vs.4.5%, p=0.2177; 30-Day: 11.3% vs.4.5%, p=0.0658; 1-Year: 12.7% 5.4%, p=0.0536). Conclusions In this real-world analysis of contemporary TAVI patients across the risk spectrum, the SAPIEN 3 Ultra THV demonstrated excellent short-term outcomes comparable to the SAPIEN 3 THV with a trend towards lower rates of permanent pacemaker implantation. Funding Acknowledgement Type of funding sources: None.

Background The optimal method for balloon-expandable transcatheter heart valve (THV) deployment remains unknown. Current implantation protocols are volume-dependent and rely on ad-hoc filling of the deployment apparatus without accounting for annular wall tension during prosthesis expansion, predisposing patients to inconsistent clinical outcomes. During THV deployment, the annular wall tension exerted by the expanding prosthesis is determined by prosthesis diameter and balloon pressure (Laplace's Law). Objective We proposed and tested a novel method for balloon-expandable THV deployment, aimed at controlling balloon pressure and the resulting annular wall tension to allow optimal prosthesis-annulus apposition while preventing significant tissue injury. Methods 330 consecutive patients with severe native aortic stenosis who underwent balloon-expandable THV implantation between 2015–2020 were included. 106 patients were considered high-risk for annular rupture. THVs were deployed until reaching a pre-determined balloon pressure; 4–4.5atm in earlier cases to establish experience and safety, later increasing to 5–6.5atm in most cases. Post-dilatation was performed to reduce >mild angiographic regurgitation (PVR). Using a biomechanical model, annular wall stress (tension) was estimated for each case and assessed against recorded rates of post-dilatation, ≥mild paravalvular regurgitation (PVR) on TTE, new PPM or LBBB and annular rupture. Results Patients with wall stress >3MPa (n=184) had reduced post-dilatation rate (p3.5MPa; no rupture occurred in 102 high-risk cases with wall stress ≤3.5MPa. Based on these results, we defined target deployment wall stress levels (3–3.5MPa) and associated deployment pressure per THV size. Patients within this target range (n=136) had 8.1% new PPM, 12.5% new LBBB, 12.7% mild PVR with no cases of ≥moderate PVR. Importantly, there was an inconsistent relationship between deployment balloon volume and resulting annular wall stress. Conclusion Pressure-regulated THV deployment is a simple, easily reproducible, safe and effective method, regardless of high-risk anatomical complexities. Funding Acknowledgement Type of funding sources: None. Annular wall stress and PVRModel, stress vs volume and new strategy