Nitinol Stent Research Articles

Bypass Versus Interwoven Nitinol Stents for Long Femoro-Popliteal Occlusions: A Propensity Matched Analysis.

To compare femoro-popliteal bypass and interwoven nitinol stenting for long occlusions of the femoro-popliteal segment. Single center retrospective propensity matching analysis of the symptomatic patients with long occlusion of the femoro-popliteal segment (> 20cm), who underwent stenting with interwoven nitinol stent or femoro-popliteal bypass from 2012 to 2020. primary patency, primary-assisted patency, secondary patency. Secondary endpoints: major adverse cardiovascular events, major adverse limb events, primary sustained clinical improvement, survival. A total of 437 patients were enrolled: 294 in the bypass group and 143 in the endovascular therapy (EVT) group. After propensity score matching, 264 and 113 patients remained in the groups, respectively. A median occlusion length was 250mm. One-year and two-year primary and secondary patency rates were comparable in both groups (two-year primary patency: 68.5% for bypass vs. 68.9% for EVT, p = 1.00). In the "above the knee" subgroup analysis, two-year secondary patency was higher in the EVT group than in the bypass group (90.9% vs. 77.5%, p = 0.048). In "below-the-knee" subgroup analysis, primary and primary assisted patency were statistically significantly higher in the EVT group than in artificial bypass subgroup (66.7% vs. 42.4%, p = .046 and 76.7% vs. 45.5%, p = .011, respectively). However, compared to autovenous bypass, the EVT group showed lower primary patency rates, although the differences are not significant. A nonselective endovascular strategy can allow for regular successful treatment of femoro-popliteal lesions longer than 25cm.

Oversizing of self-expanding Nitinol vascular stents – A biomechanical investigation in the superficial femoral artery

Despite being commonly employed to treat peripheral artery disease, self-expanding Nitinol stents are still associated with relatively high incidence of failure in the mid- and long-term due to in-stent restenosis or fatigue fracture. The practice of stent oversizing is necessary to obtain suitable lumen gain and apposition to the vessel wall, though it is regarded as a potential cause of negative clinical outcomes when mis-sizing occurs. The objective of this study was to develop a computational model to provide a better understanding of the structural effects of stent sizing in a patient-specific scenario, considering oversizing ratio OS, defined as the stent nominal diameter to the average vessel diameter, between 1.0 and 1.8. It was found that OS < 1.2 resulted in problematic short-term outcomes, with poor lumen gain and significant strut malapposition. Oversizing ratios that were in the range 1.2 ≤ OS ≤ 1.4 provided the optimum biomechanical performance following implantation, with improved lumen gain, reduced incomplete stent apposition and favourable predicted long-term fatigue performance. Excessive oversizing, OS > 1.4, did not provide any further benefit in outcomes, showing limited increases in lumen gain and unfavourable long-term performance, with higher mean strain values predicted from the fatigue analysis. Therefore, our findings predict that the optimal oversizing ratio for self-expanding Nitinol stents is in the range of 1.2 ≤ OS ≤ 1.4, which is similar to clinical observations, with this study providing detailed insight into the biomechanical basis for this.

Performance of Open and Closed Cell Laser Cut Nitinol Stents for the Treatment of Chronic Iliofemoral Venous Outflow Obstruction in Patients Treated at a Single Centre

A number of dedicated self expanding nitinol stents have been developed for use in the venous system, with both open cell (OC) and closed cell (CC) designs available. Data comparing these different designs are lacking. The objective of this study was to evaluate outcomes in patients treated with open and closed cells for unilateral chronic iliac vein obstruction. A single centre retrospective cohort study was conducted, including all patients treated with a dedicated nitinol venous stent between 2014 and 2019. Stent patency and details of re-interventions (including lysis, venoplasty, reinforcement, extension, arteriovenous fistula formation) were examined in the first post-operative year. Subgroup analysis described outcomes for patients treated with OC and CC stents ending above the inguinal ligament and those who required extension into the common femoral vein. Cox regression analysis was used to identify factors associated with loss of primary patency. A total of 207 patients were included (OC 100 patients, CC 107 patients). There was no significant difference between the groups for age (OC 42 years, CC 44 years); gender (OC and CC 67% female); presence of post-thrombotic lesions (OC 71%, CC 73%); stenting across the inguinal ligament (OC 58%, CC 56%), or presence of inflow disease (OC 49%, CC 47%). Primary and cumulative patency at 12 months were similar between groups (primary: OC 63%, CC 65%; cumulative: OC 93%, CC 90%). Patients with a CC stent across the inguinal ligament had a greater risk of needing multiple re-interventions at one year compared with those with an OC stent (odds ratio 2.84, 95% confidence interval [CI] 1.16 – 6.9) but overall, the only factor significantly associated with loss of primary patency was inflow vessel disease (hazard ratio 3.39, 95% CI 1.73 – 6.62, p < .001). OC and CC dedicated nitinol venous stents were observed to perform similarly in terms of patency and symptom improvement at one year. Disease of the inflow vessels was the most important factor associated with a loss of stent patency irrespective of stent design.

Intensive exercise therapy for restenosis after superficial femoral artery stenting: the REASON randomized clinical trial

Endovascular treatment (EVT) is the main treatment for peripheral artery disease (PAD). Despite advances in device development, the restenosis rate remains high in patients with femoropopliteal lesions (FP). This study aimed to evaluate the effectiveness of exercise training in reducing the 1-year in-stent restenosis rate of bare metal nitinol stents for FPs. This prospective, randomized, open-label, multicenter study was conducted from January 2017 to March 2019. We randomized 44 patients who had claudication with de novo stenosis or occlusion of the FP into an intensive exercise group (n = 22) and non-intensive exercise group (n = 22). Non-intensive exercise was defined as walking for less than 30 min per session, fewer than three times a week. We assessed exercise tolerance using an activity meter at 1, 3, 6, and 12 months, and physiotherapists ensured maintenance of exercise quality every month. The primary endpoint was instant restenosis defined as a peak systolic velocity ratio > 2.5 on duplex ultrasound imaging. Kaplan–Meier analysis was used to evaluate the data. There were no significant differences in background characteristics between the groups. Six patients dropped out of the study within 1 year. In terms of the primary endpoint, intensive exercise significantly improved the patency rate of bare nitinol stents at 12 months. The 1-year freedom from in-stent restenosis rates were 81.3% in the intensive exercise group and 47.6% in the non-intensive exercise group (p = 0.043). No cases of stent fracture were observed in the intensive exercise group. Intensive exercise is safe and reduces in-stent restenosis in FP lesions after endovascular therapy for PAD. Clinical trial registration: University Hospital Medical Information Network Clinical Trials Registry (No. UMIN 000025259).

Comparative retrospective analysis of the results of open femoral-popliteal bypass grafting and endovascular stenting with an interwoven biomimetic stent in patients with prolonged occlusions of the arteries in the femoropopliteal segment

Introduction. Autovenous graft is considered the gold standard for prolonged occlusive lesions of the arteries in the femoralpopliteal segment. However, the vein is not always anatomically suitable for bypass grafting; it may have been previously used in previous operations, for example, in coronary artery bypass grafting. Open surgery is always more traumatic than endovascular surgery. Conventional nitinol stents show unsatisfactory results in the femoral-popliteal position due to the high percentage of reocclusions associated with their breakage during physiological movements in the leg joints. The modified method of making interwoven nitinol stents allows improving their biomimetic properties and reducing the percentage of breakages and, accordingly, reocclusions.Material and Methods. There was a retrospective analysis of 437 patients with prolonged atherosclerotic occlusive lesion in the femoropopliteal segment (&gt; 20 cm). There were two groups: a group of bypass surgery and a group of endovascular intervention. The pseudo-randomization method of propensity score matching was used to align the groups according to various criteria.Results. Primary and secondary patency rates for one- and two-year follow up were comparable between the two groups. A subgroup analysis of above-knee intervention showed that a two-year secondary patency rate was significantly higher in the endovascular intervention group than in the bypass group (90.9% vs. 77.5%, p = 0.048). The subgroup analysis of interventions below the knee joint showed that the patency rates at two years of primary and primary-assisted patency were significantly higher in the endovascular intervention group than in the bypass group with an artificial expanded polytetrafluoroethylene (ePTFE) graft (66.7% versus 42.4%, p = 0.046 and 76.7% versus 45.5%, p = 0.011, respectively). The autovenous graft showed better results for primary patency compared with the endovascular intervention group, but the difference was statistically insignificant (77.2% versus 66.7%, respectively, p = 0.3).Conclusion. The analysis of obtained results suggests that the primary endovascular strategy may be recommended for all prolonged occlusive lesions of the femoropopliteal segment above the knee joint gap. For lesions below the knee joint, the autovenous bypass grafting remains the operation of choice, but in the absence of a suitable autovenous graft, the primary endovascular strategy may also be recommended. Additional large multicenter randomized trials are required to refine these recommendations.

The Supera Interwoven Nitinol Stent as a Flow Diverting Device in Popliteal Aneurysms

PurposeThe feasibility of using a compressed interwoven Supera stent as a flow diverting device for popliteal aneurysms was recently demonstrated in patients. It is unclear, however, what the optimal flow diverting strategy is, because of the fusiform shape of popliteal aneurysms and their exposure to triphasic flow. To assess this flow diverting strategy for popliteal aneurysms, flow profiles and thrombus formation likelihood were investigated in popliteal aneurysm models.Materials and MethodsSix popliteal aneurysm models were created and integrated into a pulsatile flow set-up. These models covered a bent and a straight anatomy in three configurations: control, single-lined and dual-lined Supera stents. Two-dimensional flow velocities were visualized by laser particle image velocimetry. In addition, the efficacy of the stent configurations for promoting aneurysm thrombosis was assessed by simulations of residence time and platelet activation.ResultsOn average for the two anatomies, the Supera stent led to a twofold reduction of velocities in the aneurysm for single-lined stents, and a fourfold reduction for dual-lined stents. Forward flow was optimally diverted, whereas backward flow was generally deflected into the aneurysm. The dual-lined configuration led to residence times of 15–20 s, compared to 5–15 s for the single stent configurations. Platelet activation potential was not increased by the flow diverting stents.ConclusionA compressed Supera stent was successfully able to divert flow in a popliteal aneurysm phantom. A dual-lined configuration demonstrated superior hemodynamic characteristics compared to its single-lined counterpart.

Evaluation and characterization of nitinol stents produced by selective laser melting with various process parameters

Evaluation and characterization of nitinol stents produced by selective laser melting with various process parameters

Urethral stenting in a dog due to compression and invasion by a liposarcoma

AbstractAn approximately 10‐year‐old, mixed breed, entire male dog was referred for acute onset of urethral obstruction. Abdominal ultrasound was unremarkable, complete blood count, serum biochemical analysis and urine analysis were all unremarkable. A retrograde urethrogram demonstrated narrowing of the urethral lumen caudal to the ischiadic arc. Urethral stenting with a self‐expanding nitinol stent was performed and the patient was without symptoms over a 6‐month period. After that time, ingrowth of tissue into the stent lumen could be seen via a new retrograde urethrogram; therefore, a covered stent was placed into the previously placed uncovered stent. Clinical signs resolved immediately. Another contrast study 4 months later demonstrated almost complete obstruction at the distal end of the stent. Scrotal ablation with perineal urethrostomy was performed and tissue samples submitted for histopathology. Liposarcoma was diagnosed. The patient was urinating without problems, but suddenly died at home 1 week after the last surgery.

Biodegradation and Immunological Parameters of Polyurethane-Based Tissue Adhesive in Arterial Microvascular Anastomoses-A Long-Term In Vivo Study.

In microsurgical anastomosis, non-synthetic fibrin-based adhesives have predominantly shown superior properties to synthetic cyanoacrylates, but they have hardly any clinical application. This study aims to investigate the local and systemic effects of synthetically produced biodegradable adhesive VIVO when used in microsurgical anastomosis. VIVO is used in two different anastomosis procedures in the common carotid artery in a rat model: VIVO in addition to a temporary catheter (VIVO TC) and VIVO with a custom-shaped memory nitinol stent (VIVO SM). Conventionally sutured anastomoses serve as controls (C). Tissue response is assessed by in vivo fluorescence imaging and histological examination. The systemic effects of biodegradation are measured using hematologic parameters and serum levels of transaminase activity and lactate dehydrogenase. Finally, the degree of local adhesion of the different anastomotic procedures is evaluated. Fluorescence imaging shows reduced inflammatory blood flow in the VIVO TC group. Histological analysis of the anastomosed vessels also reveals significantly more inflammation in C than in the two adhesive groups. The severity of VIVO adhesions proves acceptable, and no histotoxic effects of VIVO are detected. The data demonstrate that the synthetic tissue adhesive VIVO is a reliable and-compared to sutures-tissue-friendly adhesive for microsurgical anastomoses.

Treatment of Long Femoropopliteal Lesions With Self-Expanding Interwoven Nitinol Stent: 24 Month Outcomes of the STELLA-SUPERA Trial

Purpose: The performance of self-expanding interwoven nitinol stent (Supera) in femoropopliteal interventions has been proven through trials with short lesions and with relatively low proportion of occlusions. There is limited evidence of Supera stent in long lesions. The aim of this study was to assess the clinical safety and efficiency of the Supera stent in the treatment of long femoropopliteal lesions (Trans-Atlantic Inter-Society Consensus [TASC] C/D) in patients with symptomatic peripheral arterial disease (PAD). Methods: The STELLA SUPERA (STEnting Long de L’Artère fémorale superficielle par le stent métallique Supera) is a prospective, 2-center, single-arm study. Patients with symptomatic (Rutherford stages 2–6) de novo and TASC C/D lesions of the femoropopliteal segment were treated with Supera stent. The primary endpoint was the primary sustained clinical improvement at 12 months. Follow-up included clinical examination, duplex scan, and biplane X-ray up to 24 months. Results: Between December 2016 and October 2018, 48 symptomatic patients with 49 femoropopliteal lesions (TASC D = 32, 65%) were treated. The mean lesion length was 234 ± 123 mm, and 78% were total occlusion. The mean stented lesion length was 273 ± 127 mm. At 12 and 24 months, the primary sustained clinical improvement rate was 87.2% and 79.7%, respectively. The Rutherford category assessment was significantly improved at 24 months compared with baseline (p=0.02). At 24 months, the primary patency and freedom from target lesion revascularization (TLR) rates were 77.9% and 86.9%, respectively. The ankle-brachial pressure index increased from 0.62 ± 0.15 at baseline to 0.93 ± 0.15 at 24 months (p<0.0001). There were no stent fractures at 24 months. Conclusion: The use of Supera stent in long lesions (TASC C/D) is a safe and effective endovascular alternative. These results reinforce the need for randomized clinical trials to assess the value of interwoven stents for long femoropopliteal lesions.

Comparison of Interwoven Nitinol and Drug-Eluting Stents for Endovascular Treatment of Femoropopliteal Artery Disease.

Interwoven nitinol stents (INS) and drug-eluting stents (DES) were designed to improve the mid- and long-term results of femoropopliteal (F-P) angioplasty. The aim of this study was to systematically compare these stents. Between 2015 and 2017, 62 patients with symptomatic peripheral artery disease of the F-P segment treated by INS or DES were identified from a prospectively maintained institutional database. The primary outcome measure was one-year primary patency; secondary outcomes were in-stent restenosis (ISR), stent occlusion, target lesion revascularization (TLR) and mortality. The mean follow-up was 26.9 ± 11.2 months. No statistically significant difference in primary patency at one year was observed (88.6% vs. 88.9%). Throughout follow-up, overall rates of ISR (5.7% vs. 11.1%, p = 0.645), stent occlusion (25.7% vs. 7.4%, p = 0.094) and TLR (25.7% vs. 18.5%, p = 0.505) were statistically equivalent between the groups. Mortality reached 14.3% in the INS group and 3.7% in the DES group, but this difference was not statistically significant (p=0.196). Multivariable analysis revealed significant correlations between ISR and stent occlusions; popliteal lesion localization (p = 0.016) and poor below the knee vessel outflow (p < 0.001). In the short- and mid-term, the use of an INS or DES in the F-P arterial segment did not result in a difference in primary patency rate, stent occlusion, restenosis, re-intervention or mortality. The overall data do not provide any evidence to favor one stent over the other.

Investigation of mechanical behaviors and improved design of V-shaped braid stents.

V-shaped braid stents (VBSs), as highly retrievable and flexible nitinol stents, are extensively applied in endovascular diseases. They also cause less damage to vessel wall compared to tube-cutting stents. However, poor performance of VBS or suboptimal operation can give rise to unwanted clinical situations such as thrombosis and intimal hyperplasia. Therefore, research on designing factors affecting the performance of these devices is of great significance. Furthermore, simulation of stenting process can help designers understand the interactions of stents and vessel wall to reduce time to market. Thus, finite element analysis (FEA) and bench test are performed taking into account both designing factors and stenting process of VBS, including development of parametric modeling tool, research on the relationships among structural parameters and radial force, exploration of the interactions of VBS and vessel wall and pulsating load effect. This research was performed using a commercial solver Abaqus/standard with a user material subroutine (UMAT/nitinol). Structural parameters of VBS, unit-cell height and wire diameter have significant impacts on radial force, unit-cell number has slight influence on radial force, and arc diameter has almost negligible impact on radial force. Without pulsatile load, maximum stress and strain always occur in arc position; however, in pulsatile load, maximum stress and strain are gradually transformed to strut position. The stress created near vessel wall and VBS interface is higher than interaction stress due to pulsating load. The obtained result provided valuable information on the structural design of stents as well as the effects of stent on vessel wall and that vessel wall on stent deformation.Graphical abstract[Formula: see text].

Long-term Results of Interwoven Nitinol Stents to Treat the Radiocephalic Anastomotic Arteriovenous Fistula Stenosis

Introduction: Juxta-anastomotic stenosis (JXAS) is a common problem afflicting the arteriovenous fistula (AVF). This study aimed to evaluate the safety and long-term efficacy of an interwoven nitinol stent (Supera, Abbott Vascular, Santa Clara, CA, USA) in the treatment of radiocephalic AVF JXAS. Methods: A single-center, retrospective, observational study was conducted of patients with failing AVF due to JXAS treated with an interwoven nitinol stent. End points included JXAS target lesion primary patency, access circuit primary patency, assisted access circuit primary patency, and endovascular intervention rate (EIR). Results: Sixty patients were treated with a Supera stent in the JXAS between February 2014 and March 2020. One patient was excluded (AVF used for illicit drug use), leaving 59 patients (67.8% male, mean age 66.9 ± 11.4 years [range: 40–84]) with typical medical comorbidities. Overall, 45.8% of patients had previous AVF intervention. The stent was inserted with a 100% technical success rate with a mean follow-up of 729.6 ± 456.0 days (range: 5–2182 days). Juxta-anastomotic stenosis target lesion primary patency was 68.2 ± 6.6%, 53.3 ± 7.5%, and 46.2 ± 8.1% at 12, 24, and 36 months, respectively. The EIR was .64 (0–3.29) procedures/patient/year, after which the assisted access circuit primary patency rate was 94.3 ± 3.2% at 12, 24, and 36 month time points. Three thrombosed circuits occurred which were all successfully salvaged with no difference in patency by indication for procedure and no AVFs lost/abandoned out to 3 years. Avoidance of stent post-dilatation and the presence of stent mal-apposition were associated with improved primary patency, and reduced EIR, which may suggest an importance in vessel preparation prior to stent implantation. Conclusion: Interwoven nitinol stent treatment of the failing AVF with JXAS results in promising 3 year JXAS patency, with a low rate of endovascular re-intervention for those circuits developing restenosis. All AVFs were maintained over 3 years, demonstrating this treatment allows for long-term radiocephalic AVF vascular access.

Two approaches in the treatment of malignant obstructive jaundice using nitinol stents

The article presents our experience of observing two different approaches for endoscopic retrograde drainage in patients with malignant pathology of the pancreatobiliary zone, complicated by the bile duct obstruction. In one case, in case of dysfunction of the installed uncovered stent as a result of incrustation with bile salts and/or tumor invasion, stent-to-stent restenting was performed. In the second case, if it was impossible to pass the guidewire retrogradely beyond the area of the tumor narrowing, an alternative method was used – bringing it down by percutaneous transhepatic access towards the endoscope to install a retrograde stent delivery system along it using the "Rendezvous" method.

Comparison of the Covered Self-Expandable Viatorr CX Stent with the Covered Balloon-Expandable BeGraft Peripheral Stent for Transjugular Intrahepatic Portosystemic Shunt (TIPS) Creation: a Single-Centre Retrospective Study in Patients with Variceal Bleeding.

This study compares the safety and efficacy of the ePTFE-covered self-expansible nitinol stent (VIATORR® Controlled Expansion, Gore, Flagstaff, USA) with the ePTFE-covered, balloon-expandable, metallic stent (BeGraft peripheral, Bentley, Hechingen, Germany) for the creation of the transjugular intrahepatic portosystemic shunt (TIPS). From September 2016 to December 2020, 72 consecutive patients receiving TIPS for acute variceal bleeding (rescue and early TIPS, n = 15) or for prophylaxis of variceal rebleeding (n = 57) were enrolled. The main contraindications were patients with vascular liver disease (portal vein thrombosis and Budd-Chiari syndrome). Forty patients (55.6%) received a Viatorr CX stent and 32 patients (44.4%) a BeGraft peripheral stent. Safety endpoints were technical and clinical adverse events and early deaths within 30days after TIPS implantation. Efficacy endpoints were rebleeding rates, recurrence of large varices requiring endoscopic band ligation, or TIPS revision. Groups receiving the Viatorr CX or BeGraft peripheral stent were comparable in all respects except the TIPS indication for acute variceal bleeding (5% vs. 25%, p = 0.015). All patients had a successful intervention, and the physical variables of stent implantation (intervention and fluoroscopy time, reduction of the portosystemic pressure gradient) as well as adjunctive embolization of varices were similar in both groups. Severe clinical complications (Viatorr CX: 5% vs. BeGraft peripheral: 3.1%, p = 0.692), post-TIPS hepatic encephalopathy (12.5% vs. 18.8%, p = 0.743) and death (5% vs. 0%, p = 0.793) were not different between Viatorr CX and BeGraft peripheral groups. With respect to efficacy, freedom from rebleeding and from variceal band ligation during follow-up (100% vs. 100%, p = 1.0), as well as the need for shunt revision (10.5% vs. 18.8%, p = 0.327), was comparable. Compared to the present gold standard, the Viatorr CX stent, the balloon-expandable BeGraft peripheral stent, showed similar results with respect to safety and efficacy.

Performance of Open and Closed Cell Laser Cut Nitinol Stents for the Treatment of Chronic Iliofemoral Venous Outflow Obstruction in Patients Treated at a Single Centre

A number of dedicated self expanding nitinol stents have been developed for use in the venous system, with both open cell (OC) and closed cell (CC) designs available. Data comparing these different designs are lacking. The objective of this study was to evaluate outcomes in patients treated with open and closed cells for unilateral chronic iliac vein obstruction. A single centre retrospective cohort study was conducted, including all patients treated with a dedicated nitinol venous stent between 2014 and 2019. Stent patency and details of re-interventions (including lysis, venoplasty, reinforcement, extension, arteriovenous fistula formation) were examined in the first post-operative year. Subgroup analysis described outcomes for patients treated with OC and CC stents ending above the inguinal ligament and those who required extension into the common femoral vein. Cox regression analysis was used to identify factors associated with loss of primary patency. A total of 207 patients were included (OC 100 patients, CC 107 patients). There was no significant difference between the groups for age (OC 42 years, CC 44 years); gender (OC and CC 67% female); presence of post-thrombotic lesions (OC 71%, CC 73%); stenting across the inguinal ligament (OC 58%, CC 56%), or presence of inflow disease (OC 49%, CC 47%). Primary and cumulative patency at 12 months were similar between groups (primary: OC 63%, CC 65%; cumulative: OC 93%, CC 90%). Patients with a CC stent across the inguinal ligament had a greater risk of needing multiple re-interventions at one year compared with those with an OC stent (odds ratio 2.84, 95% confidence interval [CI] 1.16 - 6.9) but overall, the only factor significantly associated with loss of primary patency was inflow vessel disease (hazard ratio 3.39, 95% CI 1.73 - 6.62, p < .001). OC and CC dedicated nitinol venous stents were observed to perform similarly in terms of patency and symptom improvement at one year. Disease of the inflow vessels was the most important factor associated with a loss of stent patency irrespective of stent design.

Endoscopic stenting for stenosing cancer and digestive canal structures

Background. The purpose of the work was to evaluate the effectiveness of the endoscopic stenting method in stenosing cancer and strictures of the digestive tract. Materials and methods. Since January 2015, endoscopic stenting has been performed in 12 patients using self-expanding nitinol stents with/without polymer coating manufactured by Boston Scientific, Ltd (USA) and uncoated nitinol stents manufactured by Garson (Korea). The study included 8 men (66.7 %) and 4 women (33.3 %) aged 51–80 years, (63.0 ± 4.2) years on average. Stenosing esophageal cancer was diagnosed in 5 patients, stenosing cancer of the gastric outlet— in 3, stenosing duodenal cancer — in one, esophageal stricture — in 3 people. In all patients, the indication for stenting was impaired patency of the digestive tract due to the underlying di-sease. Results. Nutrition was restored in all patients. In the group of stenosing esophageal cancer, the 30-day mortality rate was 20%, the median survival rate was 9 months. Recurrence of dysphagia was diagnosed in one person, recanalization of the stent lumen was performed. In the group with stenosing cancer of the gastric outlet and duodenum, the 30-day mortality rate was 33.3%, the median survival rate was 11 months. Impaired gastric emptying was detected in one patient, repeated stent-to-stent stenting was performed. In the group with esophageal stricture, one individual had stent migration, so the stent was repositioned. Conclusions. Endoscopic stenting with self-expanding nitinol stents in incurable patients with malignant stenoses of the esophagus, stomach, duodenum and in those with benign esophageal strictures is the surgery of choice, a safe and effective method that allows you to restore and continue natural nutrition and thereby improve the quality of life in incurable cases. Complications arising in the late period after stenting were found in 25 % of patients, and were corrected endoscopically.

Total Aortic Arch Replacements With a 4 Branched Frozen Elephant Trunk (FET) Graft in Acute Aortic Dissection (DeBakey type I)

Total Aortic Arch Replacements With a 4 Branched Frozen Elephant Trunk (FET) Graft in Acute Aortic Dissection (DeBakey type I)

A systematic review and meta-analysis of Supera interwoven nitinol stents for the treatment of infrainguinal peripheral arterial disease.

Stenting of infrainguinal lesions can be rather challenging due to the mechanical stress applied on the arteries during motion. We assessed the short-term and mid-term safety and efficacy of Supera interwoven nitinol stent for the treatment of infrainguinal arterial disease. We conducted a systematic review for articles published from December 2011 up to May 2021 regarding studies assessing the safety and efficacy of Supera interwoven nitinol stents for the treatment of infra-inguinal peripheral arterial disease. Studies that involved synchronous application of the Supera stent and drug delivering devices, or any alternative endoprosthesis were excluded. Pooled Kaplan-Meier survival curves and smoothed hazard estimates were generated. Data were meta-analyzed using a random effects model. Primary endpoints included primary patency and freedom from clinically driven target lesion revascularization (TRL). Secondary endpoints included technical success and major amputation at 1 year post intervention. Seventeen studies with 2015 patients (65.3% males) and a mean lesion length of 137.2 mm were included. Of the total treated lesions, 44.9% involved femoropopliteal artery and 37.4% the popliteal artery. Chronic total occlusions made up 49% of the treated lesions. There were no stent fractures reported. The pooled technical success rate is 99.84% (95% CI: 99.26-100). Pooled major amputation rate at 1 year is 1.48% (95% CI: 0.47-2.87). Pooled primary patency and freedom from TLR rates at 1 year are 83.5% (95% CI: 80.24-86.54) and 90.32% (95% CI: 88.75-91.79), respectively. Pooling of individual patient data produced primary patency and freedom from TLR rates of 84.48% (95% CI: 82.66-86.11) and 90.81% (95% CI: 88.64-92.58) respectively. According to the smoothed hazard ratio estimate the risk for losing primary patency peaked between 4 and 5 months while the risk for TLR peaked between 7 and 8 months after the intervention. This review and meta-analysis indicated the safety and efficacy of Supera stents for the treatment of challenging infrainguinal lesions in the short-term and mid-term periods, with acceptable primary patency and freedom from TLR rates. Clinicians should be aware that between 4 and 5 months patients face a higher risk for event occurrence.

Transcarotid access for remote robotic endovascular neurointerventions: a cadaveric proof-of-concept study.

The purpose of this proof-of-concept study was to demonstrate the setup and feasibility of transcarotid access for remote robotic neurointerventions in a cadaveric model. The interventional procedures were performed in a fresh-frozen cadaveric model using an endovascular robotic system and a robotic angiography imaging system. A prototype remote, robotic-drive system with an ethernet-based network connectivity and audio-video communication system was used to drive the robotic system remotely. After surgical exposure of the common carotid artery in a cadaveric model, an 8-Fr arterial was inserted and anchored. A telescopic guiding sheath and catheter/microcatheter combination was modified to account for the "workable" length with the CorPath GRX robotic system using transcarotid access. To simulate a carotid stenting procedure, a 0.014-inch wire was advanced robotically to the extracranial internal carotid artery. After confirming the wire position and anatomy by angiography, a self-expandable rapid exchange nitinol stent was loaded into the robotic cassette, advanced, and then deployed robotically across the carotid bifurcation. To simulate an endovascular stroke recanalization procedure, a 0.014-inch wire was advanced into the proximal middle cerebral artery with robotic assistance. A modified 2.95-Fr delivery microcatheter (Velocity, Penumbra Inc.) was loaded into the robotic cassette and positioned. After robotic retraction of the wire, it was switched manually to a mechanical thrombectomy device (Solitaire X, Medtronic). The stentriever was then advanced robotically into the end of the microcatheter. After robotic unfolding and short microcatheter retraction, the microcatheter was manually removed and the stent retriever was extracted using robotic assistance. During intravascular navigation, the device position was guided by 2D angiography and confirmed by 3D cone-beam CT angiography. In this proof-of-concept cadaver study, the authors demonstrated the setup and technical feasibility of transcarotid access for remote robot-assisted neurointerventions such as carotid artery stenting and mechanical thrombectomy. Using transcarotid access, catheter length modifications were necessary to achieve "working length" compatibility with the current-generation CorPath GRX robotic system. While further improvements in dedicated robotic solutions for neurointerventions and next-generation thrombectomy devices are necessary, the transcarotid approach provides a direct, relatively rapid access route to the brain for delivering remote stroke treatment.