Self-expanding Nitinol Stent Research Articles

Three-Year Clinical Outcomes Following Implantation of LifeStent Self-Expanding Nitinol Stents in Patients With Femoropopliteal Artery Lesions.

The aim of this study was to evaluate midterm clinical outcomes after implantation of LifeStent self-expanding nitinol stents for the treatment of femoropopliteal lesions. This retrospective, multicenter, non-randomized study examined 260 femoropopliteal lesions in 250 consecutive patients with peripheral artery disease implanted with LifeStents from April 2016 to April 2017. The prevalence of chronic total occlusion (CTO), lesion length ≥25cm, and distal reference vessel diameter (RVD) <5mm was 58%, 35%, and 50%, respectively. The 3-year restenosis rate in the overall population was estimated to be 72.9% and a major adverse limb event was observed in 36.9%. Multivariate analysis revealed that chronic limb-threatening ischemia (CLTI) (odds ratio [OR]: 8.04; 95% confidence interval [CI]: 1.86-34.7), CTO (OR: 4.87; 95% CI: 1.43-16.6), lesion length ≥25cm (OR: 5.95; 95% CI: 1.11-32.0), and distal RVD <5mm (OR: 4.43; 95% CI: 1.34-14.6) were independent risk factors for 3-year restenosis. The present study demonstrated the midterm clinical outcomes and risk factors for restenosis after implantation of the LifeStent in femoropopliteal artery lesions. CLTI, CTO, lesion length ≥25cm, and distal RVD <5mm predicted decreased patency after a 3-year follow-up.

Common Femoral Artery Stenting: Computed Tomography Angiography Based Long-Term Patency

A retrospective, single-center study was performed from September 2012 to June 2017. Thirty-five common femoral arteries (CFAs) were treated with self-expandable nitinol stents. Two thirds of the cases were for critical limb ischemia and one third for claudication. Technical success was 100% without complications. Although the mean follow-up was only ∼2.5 years, the estimated 5-year primary and assisted primary patency rates were 80% and 96%, respectively. Endovascular treatment with self-expandable nitinol stents in CFA lesions had a high technical success rate, few complications, and high long-term patency rates. CFA stent placement might be a suitable therapeutic alternative for selected patients.

Preclinical Evaluation of the Temporary Drug-Coated Spur Stent System in Porcine Peripheral Arteries

Background: Drug penetration into the deeper arterial wall of heavily calcified lesions is one of the limitations of drug-coated balloons and drug-eluting stents in vascular interventions. The Temporary Spur Stent (TSS) system is characterized by a self-expanding nitinol stent that is uniformly covered in radialspikes, which, when coated, should allow a deeper penetration and longer retention of the drug into the diseased artery walls by penetrating through the calcified plaques. Materials and Methods and Results: Uncoated TSS and paclitaxel (PTX)-coated TSS systems have been deployed in porcine peripheral arteries. Four weeks after the deployment of uncoated TSS systems, no adverse vascular remodeling or neointimal formation in the treated vessel segments were noticed. PTX-coated TSS systems transferred 9%±7% of the drug that was on the device to the targeted vessel area (196±163 ng PTX/mg arterial tissue) and the addition of the fluorescent dye Nile red to the coating showed that the spikes promote the transfer of the coating to the deeper layers of the vessel wall. The PTX-coated TSS systems showed a significant reduction in neointimal proliferation compared to the uncoated TSS systems: quantitative angiography showed a vessel diameter stenosis of 37.2%±11.0% and 16.4%±8.8% 4 weeks after the treatment with uncoated and PTX-coated TSS systems, respectively. Conclusion: The treatment with the TSS system was well tolerated and the spikesfacilitate the transfer of the coating into deeper layers of the vessel wall. Moreover, the PTX-coated TSS systems effectively inhibit neointimal proliferation.

The Early Outcomes of BeGraft Peripheral Plus in Branched Endovascular Repair of Thoracoabdominal Aneurysms

Objective No bridging stent-graft (BSG) has been specifically designed for branched endovascular aortic repair (BEVAR) and therefore different “off-label” stent-grafts have been used. Recently, a third generation of balloon-expandable stent-graft has become available. Here we evaluate the outcomes of the BeGraft Peripheral Plus (B+) used as a BSG for internal/externalor inner branches during BEVAR. Materials and Methods Consecutive patients undergoing BEVAR using B+ as a BSG since its release in 2017 were included into the study. The primary endpoints were technical success and target vessel patency during follow-up. Secondary endpoints included the need for adjunct extension and relining of the BSG, branch instability rate, including occlusion, reinterventions for restonosis, kink, fracture, or endoleak (types 1 and 3). Results A total of 163 visceral branches in 46 patients were included with a median follow-up 15 months (4–36 months). Primary technical success was achieved in all visceral branches (69 inner branches and 94 internal/external branches) with the exception of 1 BSG that required serial dilatation until full expansion was achieved with overall branch patency was 98% at 2 years. An additional stent-graft was necessary in 35 branches (21%) following deployment of a B+ BSG to cover a longer bridging distance and optimize the distal and proximal sealing. Relining of B+ BSG was not routinely carried out during the index procedure and a self-expanding uncovered nitinol stent was necessary in only 3% of branches to smooth the distal transition zone between the BSG and target vessel. There were 4 events (2.4%) of branch related instability, including 2 occlusions and 2 late reinterventions for a partial in-stent-graft thrombosis. Conclusion Our study findings show satisfactory early outcomes of B+ as a BSG in BEVAR with low occlusion and reintervention rates. Extensions of BSG might be required to achieve adequate seal in the target vessels but routine relining BSG in branches was not required.

A case of rhabdomyolysis after atorvastatin therapy of a liver transplant recipient receiving immunosuppressive therapy with cyclosporine

Rationale. To date, liver transplantation is the most effective method of treating end-stage liver failure, and therefore this treatment has become widespread throughout the world. However, due to the improvement in the quality of transplant care and an increase in the long-term survival of patients, the development of concomitant pathology, which often requires medical treatment, is inevitably associated with a higher life expectancy of liver transplant recipients. Thus, in patients who underwent liver transplantation, there is. a significant increase in the incidence of dyslipidemia. However, a long-term immunosuppressive therapy in organ transplant patients can adversely modify the effect of the prescribed drugs, which requires careful monitoring and consideration of drug interactions.Purpose. Using a clinical example to demonstrate the importance of taking drug interactions into account in the treatment of patients after organ transplantation receiving immunosuppressive drugs.Material and methods. In the presented clinical case, a patient after orthotopic liver transplantation performed in 2005 underwent a staged treatment of cicatricial stricture of choledochal anastomosis in the S.P. Botkin City Clinical Hospital. During the following hospitalization, the patient complained of minor muscle pain when walking. At doctor's visit 3 weeks before hospitalization, a local physician prescribed therapy with atorvastatin 10 mg per day due to an increase in blood plasma cholesterol levels. The patient underwent removal of the self-expanding nitinol stent. During the follow-up examination, the patient had no evidence of an impaired bile outflow, however, muscle pain and weakness progressively increased, the rate of diuresis decreased, and in the biochemical analysis of blood there was an abrupt increase in the concentration of creatinine, aspartate aminotransferase, alanine aminotransferase. Atorvastatin was canceled, a diagnosis of acute non-traumatic rhabdomyolysis was established, treatment with hemodialysis and plasma exchange was started on 03/05/2020. The last session of renal replacement therapy was 03/30/20.Results. With the restoration of the diuresis rate, there was a spontaneous decrease in the level of creatinine to 170 μmol/L. The patient was discharged with satisfactory renal and hepatic function. The pain syndrome completely resolved. Conclusion. Drug interactions between atorvastatin and cyclosporine have resulted in acute rhabdomyolysis with life-threatening consequences. This once again confirms the importance of taking drug interactions into account when managing patients after solid organ transplantation.

Common Femoral Artery Stenting: Computed Tomography Angiography Based Long-Term Patency.

Despite considerable morbid-mortality rates, common femoral endarterectomy is still considered the gold standard for atherosclerotic common femoral artery (CFA) disease. The aim of this study was to demonstrate computed tomography angiography based long-term patency after CFA stent placement and to analyze associated risk factors for restenosis. A retrospective and observational study was carried out in consecutive patients treated with endovascular stent placement in CFA lesions. A clinical follow-up and imaging study was performed using MD-CTA to assess different degrees of in stent restenosis (ISR) and primary, assisted, and secondary patency rates. In a 5-year period, 35 extremities were treated in 33 patients with self-expandable nitinol stents. The technical success was 100% without complications related to the procedure. The mean follow-up (FU) was 32.2 months, and 8 limbs were lost. The degree of CFA stenosis was reduced from 79.69 ± 26.47% to 11.23 ± 24.53%. ISR < 20%, 20-70%, and ≥ 70% was evident in 15 (55.6%), 9 (33.3%), and 3 (11.1%) limbs, respectively. Estimated primary, assisted, and secondary patency was 79.5, 96.3, and 96.3%, respectively, after 24 months and 79.5, 96.3, and 96.3%, respectively after 60 months, with a freedom of clinical driven target lesion revascularisation rate of 87.8%. Endovascular treatment with self-expandable nitinol stents in CFA lesions had a high technical success rate and was related to few complications. A mild form of intimal hyperplasia was observed in a considerable number of cases. However, long-term patency was high; therefore, CFA stent placement might be a suitable therapeutic alternative in selected patients.

Correction to: Self-Expandable Nitinol Stents for the Treatment of Nonmalignant Deep Venous Obstruction.

Correction to: Self-Expandable Nitinol Stents for the Treatment of Nonmalignant Deep Venous Obstruction.

Implantation of a Sutureless Valve Into a Surgically Enlarged Aortic Root: A Bailout Option

Sutureless bioprostheses such as the Sorin Perceval Valve (SPV; Sorin Group, Srl, Saluggia, Italy) have been proposed for replacing stenotic native valves within small aortic roots of geriatric patients with significant comorbidity. Their use seems as safe as that of stented bioprostheses and enables significantly reduced length of surgery. Low transprosthetic pressure gradients have been measured. Because of the radial force of its self-expandable nitinol stent, aortic annulus interruption could be a relative contraindication to SPV use. Off-label implantation of the SPV into a surgically enlarged ascending aorta was first reported in this study, as a bailout option in the presence of a tiny aortic root.

Transcatheter pulmonary valve replacement: a new polycarbonate urethane valve.

Transcatheter pulmonary valve replacement has become a valid treatment option for right ventricular outflow tract diseases. However, some limitations occur in patients with wide, compliant right ventricular outflow tracts that might be amenable to treatment with self-expanding valved protheses. An experimental ovine study was designed to evaluate a novel dip-coated, low-profile trileaflet polycarbonate urethane (PCU) heart valve mounted into a self-expandable nitinol stent. The PCU valves were produced by a dip-coating technique, mounted in a conical-shaped nitinol stent and provided with a leaflet thickness of 100-150 µm. The valved stents were implanted percutaneously via transfemoral access in 6 consecutive sheep divided into 2 groups. Three animals were followed up for 1 month and the remainder, for 6 months. Angiographic measurements and transthoracic echocardiography were performed before and after implantation and at the end of the 1- or 6-month observation period, respectively. Orthotopic positioning of the valve was achieved in all animals. All except 1 had competent valves during the follow-up period. The peak-to-peak gradient across the PCU valved stents was 4.6 ± 1.0 mmHg after 1 month and 4.4 ± 2.3 mmHg after 6 months of follow-up. Macroscopic and microscopic post-mortem evaluation indicated good morphological and structural results. There were no stent fractures, leaflet calcification or thrombus formation. This study demonstrates successful transcatheter pulmonary valve replacement with a novel dip-coated valved nitinol stent. The trileaflet PCU prostheses indicated good functional and biocompatible properties after a 6-month observation period.

Endovascular balloon angioplasty for infrainguinal arterial occlusive disease: Efficacy analysis.

Background We present early and mid-term clinical outcomes of endovascular revascularization for femoropopliteal involvement of peripheral arterial disease. Methods A total of 128 patients (113 males, 15 females; mean age: 63.4±9.9 years; range, 32 to 87 years) who underwent percutaneous transluminal angioplasty for femoropopliteal lesions between August 2016 and April 2018 were analyzed retrospectively. Treatment with Luminor® paclitaxel-coated drug-eluting balloon catheter or bailout therapy with iVolution® self-expanding nitinol stent were performed. Overall patency rates and freedom from reintervention rates were analyzed using the Kaplan-Meier analysis. The primary patency and freedom from reintervention to target lesion rates at 12 and 24 months were evaluated. Results Technical success was achieved in 133 (93%) of the interventions with a median follow-up of 11 (range, 1 to 35) months. At 12 and 24 months, the mean overall patency rates were 85.6±3.7% and 66.8±6.7%, respectively and the mean freedom from reintervention to target lesion rates were 91.6±2.9% and 78.1±6.3%, respectively. The primary patency and freedom from reintervention to target lesion rates were significantly higher in the bailout stenting group than the drug-eluting balloon group at 12 months (97.3±2.7% vs. 94.8±6.1%, respectively, p=0.025 and 97.1±2.9% vs. 84.2±5.5%, respectively, p=0.005) and at 24 months (76.9±7.9% vs. 55.8±13.4%, respectively, p=0.025 and 85.2±7.0% vs. 70.2±13.6%, respectively, p=0.005). Conclusion Endovascular procedures including drug-eluting balloon and bailout stenting seem to be effective alternative treatment modalities for treatment of infrainguinal peripheral arterial disease and can be also used in patients with long lesions and/or total occlusion of femoropopliteal arteries.

The Protégé Nitinol Self-Expanding Stent for the Treatment of Iliofemoral Veno-Occlusive Disease.

To evaluate the safety and effectiveness of the Protégé nitinol self-expanding stent for the treatment of iliofemoral veno-occlusive disease. A retrospective review was performed of 376 (284 left, 92 right) Protégé stents in 212 limbs of 183 patients (mean age: 53±17years, 52% female) treated for iliofemoral veno-occlusive disease between 2011 and 2018. Binary patency was assessed with duplex ultrasound and calculated by Kaplan Meier analysis. Clinical outcomes were evaluated by clinical-etiology-anatomy-pathophysiology (CEAP) classification and Villalta scores. Adverse events were recorded and categorized per Society of Interventional Radiology reporting standards. Of the 212 limbs, 125 presented with acute thrombosis and 28 with chronic thrombosis requiring thrombectomy (n =44), catheter directed thrombolysis (n = 32), or both (n = 77). Fifty-nine limbs were non-thrombotic. Mean follow-up time was 11.44 ± 11.37months. Kaplan Meier analysis revealed a primary limb-level patency of 92.3%, 88.6%, 86.9% and 86.9% at 6, 12, 24 and 36months, respectively. CEAP and Villalta scores improved from a median of C3 (range: 0-6) to C1 (0-5) (p < 0.001) and from a mean of 13.4 ± 7.5 to 5.3 ± 4.9 (p < 0.001), respectively. Nine minor and 2 major adverse events were recorded. Endovascular treatment of iliofemoral veno-occlusive disease with the Protégé self-expanding stent appears to have good mid-term patency. Level 4, Case Series.

Effectiveness of combined superficial femoral artery endovascular therapy with popliteal-to-distal bypass: A paradigm shift in surgical open bypass for chronic limb-threatening ischemia.

The purpose of this study was to evaluate the results of combining superficial femoral artery endovascular therapy with distal bypass originating from the popliteal artery as a method of lower extremity revascularization in patients with chronic limb-threatening ischemia. The records of patients undergoing combined superficial femoral artery endovascular therapy with popliteal-to-distal bypass for chronic limb-threatening ischemia from January 2014 to April 2020 at a single institution were retrospectively reviewed. The patients' background, operative details, and long-term outcomes were analyzed. Fifty-two popliteal-to-distal bypasses with superficial femoral artery endovascular therapy were performed in 49 patients (33 men; mean age, 76 ± 9 years; diabetes mellitus, 80%; end-stage renal disease with hemodialysis, 47%). The Trans-Atlantic Inter-Society Consensus II classification of superficial femoral artery-popliteal lesion was "A" in 8 (15%) patients, "B" in 14 (27%) patients, "C" in 24 (46%) patients, and "D" in 6 (12%) patients. The intervention for superficial femoral artery lesions was plain old balloon angioplasty in 4 patients, self-expandable nitinol stent in 15 patients, drug-coated balloon in 18 patients, drug-eluting stent in 4 patients, stent graft in 10 patients, and interwoven nitinol stent in 1 patient. Distal bypass originated from the above-knee popliteal artery in 9 (17%) limbs and the below-knee popliteal artery in 43 (83%) limbs. The most common outflow artery was the posterior tibial artery (44%). The mean follow-up period was 17 ± 17 months. The primary and secondary patency of the graft was 44% and 72%, respectively, at 1 year and 39% and 72%, respectively, at 3 years. Primary patency and freedom from clinical-driven target lesion revascularization of superficial femoral artery endovascular therapy lesions were 85% and 90%, respectively, at 1 year and 63% and 75%, respectively, at 3 years. Limb salvage was 97% at 1 year and 92% at 3 years. Wound healing was 67% at 6 months and 83% at 12 months. Combined superficial femoral artery endovascular therapy with popliteal-to-distal bypass may be a promising approach for patients with chronic limb-threatening ischemia because of durable patency, acceptable wound healing, and good limb salvage.

Transcatheter mitral valve replacement: tissue in-growth after 4 weeks.

Tissue reaction to transcatheter mitral valve replacement in the mitral annulus remains to be elucidated. Trileaflet porcine pericardial valves were sewn onto self-expanding d-shaped nitinol stents, which were delivered transapically and in an off-pump fashion into the mitral position of 10 pigs. After at least 4 weeks of follow-up, gross pathological assessment and histological examination were performed. The specimens were stained with Movat's pentachrome, Elastica-van-Gieson and von Kossa staining. The leucocytes, B cells, T cells or macrophages were detected by specific immunohistochemical staining. Proper stent positioning in the mitral annulus was achieved in 9/10 animals. Nine of 10 animals survived the desired observation period. In all but one, the mitral valve stent was well integrated into the left atrium and perpendicularly embeddedinto the annulus by 85 ± 24%. One animal had minor fractures in the nitinol struts and another animal showed tearing of 1 of 4 tethers. Histological examination demonstrated no major tissue reaction with the nitninol struts but well-preserved overall structures around the mitral annulus in 8/9 cases. This is the first report demonstrating good in-growth of transcatheter-delivered anatomically shaped mitral valve stents after at least 4 weeks of follow-up. Histological examination demonstrated progressive healing and neointimalization.

Self-Expandable Nitinol Stents for the Treatment of Nonmalignant Deep Venous Obstruction

Angioplasty with stent placement is a therapeutic option for patients with acute thrombotic, postthrombotic, and nonthrombotic obstruction of the iliofemoral veins or inferior vena cava. Previous studies of steel-alloy stents described variable patency rate across indications. The prospective Swiss Venous Stent Registry includes patients treated with self-expandable nitinol stents for deep venous obstruction. Routine follow-up visits include serial duplex ultrasound for stent patency assessment. The primary outcome was primary stent patency. The secondary outcome was venous thromboembolisms. We studied the rate of stent occlusion and potentially contributing factors. We included 379 patients: 160 with acute thrombotic, 193 with postthrombotic, and 26 with nonthrombotic deep vein obstruction. The mean age was 46±18 years; 55% were women. The cumulative 3-year primary patency rate was 80.5% (95% CI, 73.0%-88.0%) for acute thrombotic, 59.2% (95% CI, 50.4%-68.0%) for postthrombotic, and 100% for nonthrombotic obstruction (log-rank, P<0.0001). Annualized rates of stent occlusion or venous thromboembolism were 7.8 (acute thrombotic), 15.0 (postthrombotic), and 0 (nonthrombotic) events/100 patient-years. In a multivariable Cox regression model, postthrombotic femoral veins at baseline (hazard ratio, 2.64 [95% CI, 1.53-4.56]) and the number of stents (hazard ratio, 1.22 [95% CI, 1.06-1.40]) were associated with stent occlusion after conditioning for age, sex, and clinically relevant factors. The rate of stent occlusion (patency loss) and venous thromboembolism varies substantially across indications, also with dedicated venous nitinol stents. Patients with postthrombotic femoral veins and those who received multiple stents were characterized by the highest risk. Registration: URL: https://clinicaltrials.gov. Unique identifier: NCT02433054.

An update on vessel preparation in lower limb arterial intervention

BackgroundPlain balloon angioplasty has traditionally been used to treat lower limb arterial disease but can be limited by significant residual stenosis, vessel recoil, dissection, and by late restenosis. Appropriate vessel preparation may significantly improve short and long-term outcomes. We aim to give an overview of some of the devices currently available, or under investigation, for vessel preparation in the lower limb.Main textVessel preparation devices include those that remove plaque (atherectomy devices) and those that modify plaque.The four groups of plaque removing atherectomy devices are defined by their plaque removal method: Directional, rotational orbital and excimer laser are categories of devices investigated for plaque modification.Intravascular lithotripsy devices generate sonic pulsatile pressure waves that pass into the vessel wall cracking calcified plaques whilst sparing soft tissue. This enables dilatation of calcified lesions at low pressure by conventional balloons and enables full stent expansion.Other balloon based vessel preparation devices were designed to modify plaque and produce more controlled, lower pressure luminal expansion without major dissections and potentially with less recoil than conventional angioplasty balloons. Scoring balloons have a helical nitinol element attached to the balloon that scores plaque facilitating uniform luminal enlargement. Further specialty balloons have been developed in recent years, including the Chocolate, Phoenix and Serranator balloons. Finally, the temporary Spur self-expanding retrievable nitinol stent has a series of radially aligned spurs that are driven into the vessel wall by post-dilatation, potentially improving drug delivery.ConclusionLesion specific vessel preparation aims to improve both short and long term outcomes through improved penetration of anti-proliferative drug, maximising luminal gain, reducing the need for stent placement and minimising intimal injury. Some forms of vessel preparation appear to improve short term outcomes; long-term outcomes remain uncertain. An overview of some of the multiple devices available for vessel preparation is presented.

Long term clinical outcome after self-expandable nitinol stent implantation for femoropopliteal occlusive disease in hemodialysis patients

Abstract Background Endovascular therapy (EVT) using self-expandable bare nitinol stent (BNS) has been commonly accepted in patients with symptomatic femoropopliteal (FP) occlusive disease. However, poor clinical outcomes in hemodialysis (HD) patients are major problems. We investigated the impact of HD on clinical outcome after EVT in patients with FP disease. Methods A total of 427 consecutive HD patients undergoing successful EVT with BNS for FP disease were enrolled with 157 non-HD patients as a control group. They were followed-up for 5 years. We collected data on target lesion revascularization (TLR) rate, and limb salvage rate as well as survival rate. Propensity-score matching analysis was performed to investigate the true impact of HD on the outcome. Results Critical limb ischemia was observed in 44.0% of overall population (43.0% in HD group vs. 46.8% in non-HD group, p=0.42). Rates of diabetes (67.1% vs. 58.1%, p=0.045) and coronary artery disease (73.5% vs. 58.3%, p=0.0008) were higher, while age (70±10 years old vs. 76±10 years old, p&amp;lt;0.0001) and TASC2 C/D lesion (27.9% vs. 44.6%, p=0.0002) were lower in HD group compared to non-HD group. Pre-procedural C-reactive protein level (0.4mg/l vs. 0.3mg/l, p=0.045) was higher and serum albumin level (3.6g/dl vs. 3.8g/dl, p=0.0045) was lower in HD group than those in non-HD group. The freedom rate from TLR at 5 years was significantly lower in HD group than in non-HD group [47.2% vs. 65.2%, hazard ratio (HR) 1.77, 95% confidence interval (CI) 1.23–2.64, p=0.0017]. The limb salvage rate was comparable between the groups (93.3% vs. 97.1%, HR 1.57, 95% CI 0.58–5.47, p=0.41), while the survival rate was significantly lower in HD group compared to non-HD group (60.6% vs. 86.0%, HR 2.53, 95% CI 1.56–4.36, p=0.0002). After propensity-score analysis, 250 patients (125 in each group) were matched without any difference of clinical characteristics in both groups. In the matched cohort, the freedom rate from TLR was still lower in HD group compared to non-HD group (46.7% vs. 66.6%, HR 2.25, 95% CI 1.35–3.87, p=0.0019). The adjusted limb salvage rate was consistently similar between the groups (95.4% vs. 97.3%, HR 1.10, 95% CI 0.20–5.94, p=0.91). Also, the adjusted survival rate was lower in HD group than in non-HD group (47.6% vs. 89.9%, HR 3.60, 95% CI 1.89–7.44, p&amp;lt;0.0001). Conclusion The freedom rate from TLR at 5 years after BNS implantation for FP disease were significantly lower in HD group than in non-HD group, though the limb salvage rate was similar between the groups. The survival rate was consistently lower in HD group compared to non-HD group. HD status had a great impact on TLR and mortality after EVT with BNS in patients with FP disease. Funding Acknowledgement Type of funding source: None

Comparison between cheatham-platinum stent and self-expandable uncovered nitinol stent in patients with coarctation of aorta – a randomized controlled trial

Abstract Background Endovascular treatment is considered the main therapeutic approach for native coarctation of aorta (CoA) in adult patients. Balloon-expandable stents (BE) have been introduced as the primary choice for coarctoplasty. However during the recent years, self-expandable (SE) stents with acceptable radial force have been suggested as an alternative. Still, no randomized controlled (RCT) trials have compared the efficacy and safety of both strategies. Methods The present study is a prospective, single center, parallel-group, open-label RCT on patients with native CoA (Figure). Patients were randomized into Bare Cheatham-Platinum Stents and Uncovered Nitinol Stent (SE). All patients were scheduled to be followed in 1-, 6-, 12-month and 36-month intervals. The present report, focuses on the one-year outcome of the study. Results Of 101 patients with native CoA referred to our center, 93 patients have been randomized into BE- (47 patients) and SE-arm (46 patients). One year follow up is scheduled to be completed on March 2020. In the preliminary analysis of 62 patients, 1 intraprocedural stent migration has occurred in each group. No aortic perforation was detected in the study. Vascular access site complications were similar between the two groups (3 (6.3%) in BE versus 1 (2.1%) in SE, p value= 0.432). One nonfatal stroke occurred in BE group. No mortality or bailout surgical repair happened in one year study in the two groups. One patient with re-coarctations were detected during one year follow up in each of the groups (p value=0.210). No aortic pseudoaneurysm or aneurysmal formation were observed in 12-month follow up aortic CT angiography. Conclusion The preliminary results showed no significant difference in efficacy and safety of both treatment modalities. The final result is pending. Study Flow Chart Funding Acknowledgement Type of funding source: None

The first experience with the fully-covered self-expandable nitinol stents in the management of anastomotic biliary strictures after orthotopic liver transplantation

Background: Biliary anastomosis strictures after orthotopic liver transplantation (OLT) develop in 5–12% of patients. This complication significantly impairs the patients’ quality of life and can lead to graft loss.Aim: To analyze the first experience in the use of coated self-expanding nitinol stents in patients with biliary anastomosis strictures after OLT.Materials and methods: From December 2018 to January 2019, there were 5 patients with anastomotic strictures after OLT in the Department of Organ and/or Tissue Transplantation of the S.P. Botkin Municipal Clinical Hospital. All patients underwent endoscopic stenting of strictures with a self-expanding nitinol-coated stent. In all patients, the stent was removed at 3 months after its placement.Results: No complications and deaths were recorded in this patient group. The median duration of the follow-up after stent removal was 14.15 ± 2.35 (3–17) months, with no cases of restenosis identified.Conclusion: The use of coated nitinol stents in the management of patients with anastomotic strictures after liver transplantation is effective and safe. The possibility of their use in routine clinical practice requires confirmation in further studies.

İliak Arter ve Alt Ekstremite Periferik Arter Hastalıklarında Endovasküler Tedavi

Objective: Methods of endovascular therapy have been increasingly used in addition to conventional surgical approaches in the treatment of peripheral arterial diseases. This study aims to evaluate to the endovascular treatment methods that we use in patients with peripheral arterial disease.&#x0D; Materials and Methods: We retrospectively analyzed twenty-four of patients were treated with endovascular method. Nineteen of the patients had intermittent claudication, 4 had rest pain and one patient with bilateral popliteal artery aneurysms had pain at the back of bilateral knee joints. Twenty patients were male and 4 were female. The mean age was was 55,26± 10,95( 38-81) years. Evaluations included clinical assesment according to Fontaine stages. Doppler examinations with ankle-brachial index (ABI) and bilateral lower extremity arteriograms. Ten of the patients who underwent endovascular therapy had a lesion in TASCII-A group, 5 had a TASCII-B lesion, and TASCII-C lesions were present in 9 patients. All patients were followed prospectively with arterial duplex scan.&#x0D; Results: Bioabsorbable stent was implanted in 11 patients. Balloon angioplasty was performed in 3 patients. A self-expandable nitinol stent was deployed in 3 patients. Subintimal balloon angioplasty was performed in 6 patients. An aneurysm repair was performed with stent graft in 1 patient who had bilateral popliteal and right anterior tibial artery aneurysms. Initial technical and hemodynamic success was achieved in 100% of cases. Preoperative 0,67±0,13 (0,4-0,95) and after one year later 0,94±0,07 (0,8-1) analysis for ABI revealed statistically significant (p

EUS-guided recovery of colonic continuity after complete anastomotic stenosis with a nitinol self-expanding stent

Recovery of intestinal continuity is remaining a complex issue in abdominal surgery. Previous operations, such as Hartmann's procedure, are usually done in the emergent setting, often in frail and septic patients. As a result, severe adhesions occur, and recognition of various anatomical structures becomes more difficult.The article describes a clinical case of EUS-guided recovery of rectum's continuity after complete anastomotic stenosis. The operation “EUS-guided formation of rectosigmoid anastomosis using Lumen-Apposing Metal Stent” was performed.In order to obtain a stable anastomosis within 6 months, a session of bougienage and 4 sessions of balloon dilatation were performed. Currently, the diameter of the colon at the stricture level is about 14 mm, clinically stricture is not significant.EUS-guided enterostomy can be used to form an intestinal anastomosis in patients with benign diseases. However, this method alone is not the final method of treatment and requires further supervision of patients.