Magnesium bioresorbable scaffold (Magmaris) versus polymer biodegradable ultrathin drug-eluting stent (Ultimaster) in acute coronary syndrome. Mid-term outcomes (2 years).

Introduction: Acute coronary syndrome (ACS) is a well-known risk factor for adverse clinical outcomes in percutaneous coronary intervention (PCI). Therefore, evaluation of coronary stents in this challenging clinical scenario can provide unique information on device safety and efficacy. Bioresorbable scaffolds (BRS) were designed to overcome long-term complications related to permanent vessel caging with a permanent metallic drug-eluting stent (DES). Aim: We designed this study to evaluate the mid-term safety and efficiency of the Magmaris BRS in comparison to the leading new-generation ultrathin DES Ultimaster in the ACS population. Material and methods: We present a retrospective analysis of 2-year follow-up data. The primary outcomes consisted of death from cardiac causes, myocardial infarction, and in-stent thrombosis. The second main study endpoint was defined as target-lesion failure (TLF). Results: The study population consisted of two cohorts, the first of 193 patients treated with Magmaris implantation and the second of 169 patients treated with Ultimaster implantation. At the 2-year follow-up, there were no significant differences in both study cohorts in terms of primary outcome (5.1% vs. 11%; p = 0.051), and TLF (5.6% vs. 8%, p = 0.41). Conclusions: Treatment with a second-generation BRS (Magmaris) versus a novel second-generation DES (Ultimaster) in non-ST-elevation acute coronary syndrome (NSTE-ACS) was associated with similar rates of target lesion failure at 2-year follow-up.

Clinical application of the retrograde track method in reopening dysfunctional biliary stents.

Background: Biliary stent dysfunction is challenging to treat in clinic. The retrograde track method (RTM) has a promising clinical application in the reopening of dysfunctional biliary stents. This study aimed to evaluate the clinical value of the RTM in reopening dysfunctional biliary stents. Methods: From February 2013 to January 2020, 151 patients underwent percutaneous transhepatic biliary interventional procedures for reopening dysfunctional biliary stents at the First Affiliated Hospital of Zhengzhou University, and 25 patients (12 females, 13 males; mean age 63.12 years old) underwent the RTM after anterograde reopening dysfunction biliary stent failure. Technical success, clinical success, irradiation dose, procedure time, complications, and overall survival (OS) were recorded, and levels of total bilirubin (TBIL), direct bilirubin (DB), alanine aminotransferase (ALT), albumin (ALB), and carbohydrate antigen-199 (CA-199) were compared before treatment and 1 month after treatment. Results: The technical and clinical success rates were 100% and 96%, respectively, and the irradiation dose and procedure times were 774.07±330.80 mGy and 45.16±9.48 min, respectively. Two patients (8%) experienced major complications. The median OS was 10.73 months [95% confidence interval (CI): 9.37-12.09]. Compared with pretreatment values, the mean levels at 1 month after RTM administration for TBIL (189.47±59.20 vs. 44.65±16.12 µmol/L), DB (144.21±55.83 vs. 27.95±13.86 µmol/L), ALT (89.62±30.85 vs. 49.44±14.25 U/L), and CA-199 (584.59±269.82 vs. 176.76±100.68 U/mL) showed significant decreases, while that of ALB (36.32±2.05 vs. 40.22±1.95 g/L) showed a significant increase (all P values <0.05). Conclusions: RTM is an effective alternative treatment method when anterograde reopening of a dysfunctional biliary stent occurs.

Case report: the 'vanished' left pulmonary artery.

Background: We report a case of isolated ductal origin of pulmonary artery (DOPA) diagnosed in an asymptomatic newborn. The primary aim of this case is to highlight the need to investigate for DOPA in patients diagnosed with an 'absent branch pulmonary artery'. Case summary: Our patient was an asymptomatic newborn infant, with normal intracardiac anatomy. He was initially diagnosed post-natally with 'absent left pulmonary artery' (LPA), though the LPA was seen in antenatal scans. He underwent angiography and was re-diagnosed with bilateral arterial ducts, with ductal origin of the LPA from the left arterial duct. The LPA was salvaged by first stenting the left arterial duct on Day 11 of life, with subsequent surgery to connect the LPA to the main pulmonary artery at 4.5 months old. The patient had an uneventful recovery after the surgery. Discussion: Ductal origin of pulmonary artery is a rare vascular anomaly characterized by continuity of the left or right pulmonary artery (PA) with the distal end of the arterial duct, and discontinuity with the main PA. It is commonly misdiagnosed as pulmonary artery agenesis when the patent arterial duct constricts, with cessation of blood flow into the affected pulmonary artery. A high index of suspicion is necessary for diagnosis of DOPA. Once diagnosed, this lesion is clearly amenable to intervention, with benefits from unifocalization, to prevent late onset pulmonary hypertension or cardiac failure.

Stent plus balloon-assisted coiling with low-profile braided stents in the treatment of complex wide-necked intracranial bifurcation aneurysms.

INTRODUCTION: Wide-necked bifurcation aneurysms pose significant challenges for endovascular treatment. A recent innovation, the stent plus balloon-assisted coiling technique, combines a stent and a balloon to address these aneurysms effectively. PURPOSE: To evaluate the safety and efficacy of the stent plus balloon-assisted coiling for the treatment of wide-necked bifurcation aneurysms. METHODS: We conducted a retrospective review of our endovascular database to identify patients who were treated with this technique and had a satisfactory angiographic follow-up of at least 24 months. Technical success, initial clinical and angiographic outcomes, procedural complications, and follow-up results were analyzed. Angiographic and clinical outcomes were assessed using Modified Raymond-Roy Classification and Modified Rankin Scale, respectively. RESULTS: Our study included 37 aneurysms in 36 patients (26 females) with a mean age of 56.6 years. Mean aneurysm and neck sizes were 7.3 ± 3.5 mm and 3.7 ± 1.0 mm, respectively. Technical success reached 97.2%, with an immediate occlusion rate of 65.7%. At a mean follow-up of 36.5 ± 9.7 months, final angiographic follow-up showed a 91.9% complete occlusion rate. Three aneurysms did not achieve complete occlusion; however, none required retreatment. Complications developed in 32.4% of the procedures. Mortality and morbidity rates were 5.4% and 2.7%, respectively. A good clinical outcome was observed in 91.9% of patients. CONCLUSION: Our results showed that stent plus balloon-assisted coiling technique allows good angiographic outcomes for wide-necked bifurcation aneurysms. However, overall complication rate is high. Subgroup analysis indicated promising safety and efficacy for MCA bifurcation aneurysms, suggesting this technique could be a valuable option for select aneurysms.

Histopathological findings of failed blebs after microinvasive bleb surgery with the XEN Gel Stent and Preserflo MicroShunt.

PURPOSE: The success of XEN Gel Stent (XEN) and Preserflo MicroShunt (Preserflo) implantation depends mainly on the development of bleb fibrosis. This study aimed to describe the histological findings of bleb fibrosis after XEN and Preserflo surgery. METHODS: This retrospective study included patients with different types of glaucoma who underwent revision surgery after XEN or Preserflo implantation. The available clinical information and histological samples of removed fibrotic tissue were analyzed. RESULTS: Thirty-six patients were included. Revision surgery was performed at a median of 195 (range = 31-1264) days after primary surgery. The mean intraocular pressure changed from 29.1 (± 10.3) mmHg at baseline to 18.3 (± 8.7) mmHg (- 37%; p < 0.0001) and 16.2 (± 4.2) mmHg (- 45%; p < 0.0001) after 6 and 12 months, respectively. Histological analysis revealed an increase in activated fibroblasts and macrophages in all specimens and a parallel orientation of fibroblasts in a minor part of the probe in 60% of the specimens. No pronounced inflammatory reaction in the form of lymphocytic or granulocytic infiltration was observed. The comparison of specimens from uveitic glaucoma and primary open-angle glaucoma patients revealed no significant differences. CONCLUSIONS: The histological analysis of fibrotic blebs from the XEN and Preserflo implants did not show any pronounced immune or foreign-body reaction and revealed a similar histological pattern of failed blebs after trabeculectomy.

Impact of the number of modifiable risk factors on clinical outcomes after percutaneous coronary intervention: An analysis from the e-Ultimaster registry.

Aims: A substantial proportion of the patients undergoing percutaneous coronary intervention (PCI) have none of the of standard modifiable cardiovascular risk factors (SMuRFs): hypertension, diabetes, hypercholesterolaemia and smoking. The aim of this analysis was to compare clinical outcomes after PCI according to the number of SMuRFs. Methods: Patients with an indication for a PCI were stratified based upon the number of SMuRFs: 0, 1, 2 or 3-4. The primary outcome was target lesion failure (TLF), a composite of cardiac death, target vessel-related myocardial infarction or clinically driven target lesion revascularization at 1-year. Inverse weighted propensity score (IWPS) adjustment was performed to adjust for differences in baseline characteristics. Results: The prevalence of SMuRFs was: 0 SMuRF 16.4 %; 1 SMuRF 27.8 %; 2 SMuRFs 34.7 % and 3-4 SMuRFs 21.1 %. Patients without SMuRFs were younger, more likely to be male and had less complex coronary artery disease. The incidence of TLF increased with the number of SMuRFs: 2.65 %, 2.75 %, 3.23 %, and 4.24 %, Ptrend < 0.001. The relative risk (RR) for a TLF was 60 % higher (95 % confidence interval 1.32-1.93, p < 0.01) for patients with 3-4 SMuRFs compared to patients without SMuRFs. The trend remained (Ptrend < 0.01) after IWPS with TLF rates of 2.88 %, 2.64 %, 2.88 % and 3.65 %. The RR for a TLF was 27 % higher (95 % CI 1.05-1.53, p < 0.01). Conclusion: The incidence of clinical events at 1-year increased with the number of SMuRFs. While patients without SMuRFs have a relatively favourable risk profile, more research is needed to optimize therapeutic management in the majority of patients.

Successful endovascular thrombectomy using solitaire FR stent with intermediate catheter assisting technique for acute persistent primitive trigeminal artery and basilar artery occlusion: A case report and literature review.

Background: The persistent primitive trigeminal artery (PPTA) is a persistent embryological carotid-basilar connection. Endovascular thrombectomy (EVT) for hypoplastic PPTA occlusion is a challenge. This case report aims to describe the successful recanalization of simultaneous occlusions in both the PPTA and basilar artery (BA) using the Solitaire FR (RECO SR)/Stent and Intermediate Catheter Assisting (SWIM) technique in a patient with acute cardiogenic cerebral embolism. To the best of our knowledge, this is the first report of such a case. Case Description: We present a case of a 70-year-old female patient who presented with acute right-sided hemiparesis and altered consciousness. Digital subtraction angiography confirmed the occlusion of both the distal portion of the PPTA and the BA. The patient underwent EVT using the SWIM technique, resulting in successful recanalization and significant improvement in the patient's condition. Conclusion: This case report demonstrates the successful application of the SWIM technique in achieving recanalization and improving outcomes in a patient with simultaneous occlusion of the acute PPTA and BA. These findings support the potential use of EVT in similar cases.

Novel insights into thoracic endografts technology for prevention of distal stent-graft induced new entry (dSINE) following endovascular repair of type B aortic dissections: from bench to bedside.

INTRODUCTION: Endovascular treatment of type B aortic dissections (TBAD) has currently acquired a primary therapeutic role when anatomically feasible. The main issue with thoracic endovascular aortic repair (TEVAR) for aortic dissection is the actual nature of the aortic wall, which is structurally compromised and more fragile. Indeed, a wealth of data have shown that TEVAR for TBAD will lead, in a substantial proportion of cases, to a device-related adverse event named distal stent-graft induced new entry (dSINE). AREAS COVERED: Currently available aortic stent-grafts have not been specifically devised for the treatment of aortic dissection. A novel dissection specific stent-graft (DSSG) was developed, which is a custom-made device based on the Zenith Alpha Thoracic platform (Cook Medical). The DSSG has several unique properties that, in principle, make its use optimal in TBAD patients. EXPERT OPINION: TEVAR in the setting of aortic dissections remains technically challenging. The occurrence of dSINE represents a unique complication in this scenario and may lead to high rates of aortic-related adverse events and need for secondary interventions. The use of a novel custom-made DSSG in the setting of chronic TBAD has been proven to be safe, feasible and effective. However, even this approach may fail to completely prevent dSINE formation.

A core-lab adjudicated analysis of single-stent assisted coiling of wide-neck bifurcation aneurysms.

BACKGROUND AND PURPOSE: Core-lab adjudicated data regarding the efficacy of the single-stent assisted aneurysm coiling technique 'L-stenting' are lacking. We present a multicenter, core-lab adjudicated study evaluating the safety and effectiveness of single-stent assisted coiling in the treatment of wide-neck bifurcation aneurysms (WNBAs). METHODS: Consecutive patients who underwent L-stenting for WNBAs at three academic institutions between 2015 and 2019 were included in this retrospective study. Clinical safety and efficacy outcomes were gathered from the patient chart, and angiographic imaging was evaluated by core lab analysis. Safety and efficacy outcomes were summarized and predictors of safety and efficacy were calculated. RESULTS: Of 128 patients treated, 124 had angiographic outcome data at last follow-up. Of those, 110 had adequate (core-lab adjudicated modified Raymond Roy (mRR) score of 1 or 2) occlusion (88.7%). During follow-up, 19 patients (14.8%) required retreatment. There were 17 complications experienced in 12 patients: intraoperative (n=8, 6.25%), perioperative (n=5, 3.9%), or delayed (n=6; n=4 attributed to device/procedure, 3.1%). Significant predictors of complete occlusion were smaller aneurysm size and use of the jailing technique (P=0.0276). Significant predictors of retreatment were larger size, neck size, and larger dome to neck ratio (P=0.0008). CONCLUSION: This study provides multicenter, core-lab adjudicated angiographic data regarding the efficacy of single-stent assisted coiling for WNBAs. This study acts as a validated comparator for future studies investigating novel devices or techniques for treating this challenging subgroup of aneurysms.

Initial Experience with a New Self-Expanding Open-Cell Stent System with Antithrombotic Hydrophilic Polymer Coating (pEGASUS Stent) in the Treatment of Wide-Necked Intracranial Aneurysms.

PURPOSE: We report our initial experience with endovascular embolization of intracranial aneurysms using this new self-expanding open-cell stent system (pEGASUS stent system) with the antithrombogenic hydrophilic polymer coating. MATERIALS AND METHODS: We retrospectively reviewed all patients treated with stent-assisted coiling or the Woven EndoBridge device using the pEGASUS stent system between September 2022 and June 2023. Demographic, clinical, and angiographic data were analyzed as well as short-term follow-up, including procedural complication rates and aneurysmal occlusion rates using the Raymond-Roy occlusion classification (RROC). RESULTS: Twelve patients with 12 wide-necked intracranial aneurysms were treated with the pEGASUS stent system, including 2 acutely ruptured aneurysms embolized in an emergency setting. The treated aneurysms were located at the anterior communicating artery (25.0%), the basilar artery (50.0%), the middle cerebral artery (16.7%), and the internal carotid artery (8.3%). All stents were deployed successfully. Immediate complete aneurysmal occlusion (RROC class I) was achieved in 83.3% (10/12) and near-complete occlusion (RROC II) in 16.7% (2/12). No periprocedural complications occurred in patients treated in the elective setting. A single case of intraoperative in-stent thrombus formation occurred during the treatment of an acutely ruptured basilar aneurysm and was resolved with intravenous Tirofiban. No other periprocedural complications occurred. Eleven out of 12 patients were available for follow up (mean 7.4 months). Complete aneurysmal occlusion without in-stent stenosis (ISS) was seen in 10 patients (90.9%). One patient (9.1%) showed aneurysmal reperfusion (RROC IIIb) with asymptomatic moderate ISS. CONCLUSION: Our initial results demonstrate that the pEGASUS stent system appears to be a safe and effective device for stent assisted embolization of wide-necked intracranial aneurysms. More data is necessary to evaluate long-term follow-up.

Successful treatment of a large profunda femoris artery aneurysm and associated pseudoaneurysm using endovascular stenting.

Profunda femoris artery aneurysms are a rare form of peripheral arterial aneurysm. In this report, we present the case of an 83-year-old lady who was found to have a 65 mm aneurysm arising from the proximal left profunda femoris artery and associated pseudoaneurysm. Successful treatment was achieved using an endovascular approach in which two stents were deployed.

Dissection flap fenestration can reduce re-apposition force of the false lumen in type-B aortic dissection: a computational and bench study.

Thoracic endovascular aortic repair (TEVAR) has been widely adopted as a standard for treating complicated acute and high-risk uncomplicated Stanford Type-B aortic dissections. The treatment redirects the blood flow towards the true lumen by covering the proximal dissection tear which promotes sealing of the false lumen. Despite advances in TEVAR, over 30% of Type-B dissection patients require additional interventions. This is primarily due to the presence of a persistent patent false lumen post-TEVAR that could potentially enlarge over time. We propose a novel technique, called slit fenestration pattern creation, which reduces the forces for re-apposition of the dissection flap (i.e., increase the compliance of the flap). We compute the optimal slit fenestration design using a virtual design of experiment (DOE) and demonstrate its effectiveness in reducing the re-apposition forces through computational simulations and benchtop experiments using porcine aortas. The findings suggest this potential therapy can drastically reduce the radial loading required to re-appose a dissected flap against the aortic wall to ensure reconstitution of the aortic wall (remodeling).

Analysis of Aortic Arch Hemodynamics With Simulated Bird's Beak Effects.

OBJECTIVE: The objective of this study was to investigate the flow effects in different degrees of thoracic aortic stent graft protrusion extension by creating bird beak effect simulations using accurate 3D geometry and a realistic, nonlinear, elastic biomechanical model using computer-aided software SolidWorks. METHODS: Segmentation in 3D of an aortic arch from a computed tomography (CT) scan of a real-life patient was performed using SolidWorks. A parametric analysis of three models was performed: (A) Aortic arch with no stent, (B) 3 mm bird-beak configuration, and (C) 6.5 mm bird-beak configuration. Flow velocity, pressure, vorticity, wall shear stress (WSS), and time average WSS were assessed. RESULTS: The flow velocity in Model A remained relatively constant and low in the area of the ostium of the brachiocephalic artery and doubled in the left subclavian artery. On the contrary, Models B and C showed a decrease in velocity of 52.3 % in the left subclavian artery. Furthermore, Model B showed a drop in velocity of 82.7% below the bird-beak area, whereas Model C showed a decline of 80.9% in this area. The pressure inside the supra-aortic branches was higher in Model B and C compared with Model A. In Model A, vorticity only appeared at the level of the descending aorta, with low to non-vorticity in the aortic arch. In contrast, Models B and C had an average vorticity of 241.4 Hz within the bird beak area. Regarding WSS, Model A, and Model B shared similar WSS in the peak systolic phase, in the aortic arch, and the bird beak area, whereas Model C had an increased WSS by 5 Pa on average at these zones. CONCLUSION: In the present simulations' lower velocities, higher pressures, vortices, and WSS were observed around the bird beak zone, the aortic arch, and the supra-aortic vessels.

Removal method of a Supera interwoven stent invaginated during its implantation in endovascular procedure: a case report.

BACKGROUND: Supera interwoven stents (IWS) have a unique interwoven structure; thus, precise stent placement can be challenging as they are prone to elongation, shortening, and invagination. Particularly, invagination limits long-term patency. This proposed method aims to remove invaginated IWS. CASE PRESENTATION: A 70-year-old man presented with intermittent claudication in his left lower limb. Endovascular therapy was conventionally performed, and a 5.5 × 40 mm IWS was placed after balloon dilatation; however, invagination occurred. The invaginated IWS was successfully removed by a threading 0.014" wire through the outside of the stent strut, and a snare catheter was used to hold it in place from the inside. Then, while still in place, the 0.014" wire and snare catheter were driven into the guiding sheath. CONCLUSIONS: This practical and easy approach to remove invaginated IWS from the body relies on the particular structural characteristics.

Optimization of Enzymatic and Chemical Decellularization of Native Porcine Heart Valves for the Generation of Decellularized Xenografts.

One of the most important medical interventions for individuals with heart valvular disease is heart valve replacement, which is not without substantial challenges, particularly for pediatric patients. Due to their biological properties and biocompatibility, natural tissue-originated scaffolds derived from human or animal sources are one type of scaffold that is widely used in tissue engineering. However, they are known for their high potential for immunogenicity. Being free of cells and genetic material, decellularized xenografts, consequently, have low immunogenicity and, thus, are expected to be tolerated by the recipient's immune system. The scaffold ultrastructure and ECM composition can be affected by cell removal agents. Therefore, applying an appropriate method that preserves intact the structure of the ECM plays a critical role in the final result. So far, there has not been an effective decellularization technique that preserves the integrity of the heart valve's ultrastructure while securing the least amount of genetic material left. This study demonstrates a new protocol with untraceable cells and residual DNA, thereby maximally reducing any chance of immunogenicity. The mechanical and biochemical properties of the ECM resemble those of native heart valves. Results from this study strongly indicate that different critical factors, such as ionic detergent omission, the substitution of Triton X-100 with Tergitol, and using a lower concentration of trypsin and a higher concentration of DNase and RNase, play a significant role in maintaining intact the ultrastructure and function of the ECM.

Mechanical behaviors of a new elliptical valve stent in bicuspid aortic valve.

BACKGROUND AND OBJECTIVE: The conventional valve stents that are cylindrical in shape will become elliptical when implanted in bicuspid aortic valve, thereby reducing the durability of the artificial valve. In this study, a new design of valve stent is presented where valve stents have elliptical cross-section at the annulus and it is expected to have better expandability and circle shape during the interaction between the stent and bicuspid aortic valve, thereby extending the durability of artificial valve. METHODS: Finite element method (FEM) is used to study the mechanical behavior of the novel valve stent in the bicuspid aortic valve. The effects of three matching relationship between the ellipticity of the stents and the ellipticity of the annulus (i.e., the ellipticity of the stent is greater than, equal to and less than the annulus ellipticity, respectively) on the mechanical behavior of stent expansion are studied. In addition, the expansion mechanical behavior of the novel valve stent at different implantation depths is also compared. RESULTS: Results indicate that novel valve stent implantation with elliptical features is superior to conventional circular valve stent. When the novel valve stent ellipticity is less than the annulus ellipticity, the ellipticity of the novel valve stent after implantation is smaller than that of the conventional circular valve stent. This indicated that the novel valve stent has better expandability and post-expansion shape, making artificial valve to have better durability. The risk of paravalvular leak after implantation is lowest when the novel valve stent ellipticity is less than annulus ellipticity. When the novel valve stent ellipticity coincides with annulus ellipticity, the aortic wall is subjected to greatest stress. With the increase of implantation depth, the stress on the novel valve stent decrease. CONCLUSIONS: This study might provide insights for improving stent design for bicuspid aortic valve.

Pivotal Evaluation of Novel Dedicated Venous Stent for Iliofemoral Venous Obstruction: A Prospective Cohort Study.

PURPOSE: The purpose was to evaluate the clinical outcomes of a dedicated venous stent with the tripartite composite segments for the treatment of iliofemoral venous obstruction (IVO) in a mixed cohort of nonthrombotic iliac vein lesion (NIVL) and post-thrombotic syndrome (PTS) over a period of 12 months. METHODS: The Grency Trial is a prospective, multicenter, single-arm, open-label, pivotal study, which was conducted at 18 large tertiary hospitals in China from August 2019 to October 2020. A total of 133 hospitalized patients were screened and 110 patients with clinical, etiology, anatomical, and pathophysiology clinical class (CEAP) clinical grade C>3 and iliac vein stenosis >50% or occlusion, including 72 patients with NIVL and 38 patients with PTS, were implanted with Grency venous stents. Primary endpoint was stent patency at 12 months follow-up, and secondary outcomes were technical success; improvement in venous clinical severity score (VCSS) at 3, 6, and 12 month follow-up; and rates of clinical adverse events. RESULTS: Among 110 patients who were implanted with Grency venous stents, 107 patients completed the 12 month follow-up. All 129 stents were successfully implanted in 110 limbs. Twelve-month primary patency rate was 94.39% [95% confidence interval [CI]=88.19%-97.91%] overall, and 100% [94.94%-100%] and 83.33% [67.19%-93.63%] in the NIVL and PTS subgroups, respectively. Venous clinical severity score after iliac vein stenting improved significantly up to 12 months follow-up. There were 3 early major adverse events (1 intracerebral hemorrhage and 2 stent thrombosis events related to anticoagulation therapy), and 7 late major adverse events (1 cardiovascular death, 1 intracranial hemorrhage with uncontrolled hypertension, and 5 in-stent restenosis cases without stent fractures or migration). CONCLUSIONS: The Grency venous stent system appeared excellent preliminary safe and effective for IVO treatment. Further large-scale studies with longer-term follow-up are needed to evaluate long-term patency and durability of stent. CLINICAL IMPACT: The design of venous stents for iliofemoral venous obstruction (IVO) must address engineering challenges distinct from those encountered in arterial stenting. The Grency venous stent, a nitinol self-expanding stent specifically tailored for IVO, features a composite structure designed to meet the stent requirements of various iliac vein segments. The Grency Trial is a prospective, multicenter, single-arm, open-label pivotal study aimed at evaluating the efficacy and safety of the Grency stent system. Following a 12-month follow-up period, the Grency venous stent system has demonstrated both safety and efficacy in treating iliofemoral venous outflow obstruction.

Effectiveness and Safety of Endoanchors in Abdominal and Thoracic Endovascular Aneurysm Repair: A Systematic Review and Meta-analysis.

PURPOSE: This systematic review aimed to summarize the effectiveness and safety of endoanchor, a stabilizing device for the proximal endograft designed to prevent endoleak and stent migration in endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR). MATERIALS AND METHODS: A systematic review and meta-analysis was conducted per the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guideline. Literature up to May 31, 2023 was searched and independently screened from 4 databases. Data were pooled for meta-analysis. Primary outcomes included intraoperative and follow-up endoleak, stent migration, and reintervention rates; sac regression; and 30-day all-cause mortality. RESULTS: Sixteen EVAR (n=1145) and 6 TEVAR studies (n=163) using the Heli-Fx EndoAnchor system were included from 2225 retrieved records. For EVAR patients (mean follow-up=11.9 months), the endoleak, graft migration, and reintervention rates were 3.97% (95% confidence interval [CI]=0.36%-1.99%), 0.004% (95% CI=0.00%-0.76%), and 5.43% (95% CI=0.86%-12.54%), respectively. The endoleak rates for primary and revision EVAR were 0.16% (95% CI=0.00%-1.65%) and 3.60% (95% CI=0.14%-9.72%), respectively. Only 4 cases of 30-day mortality (n=4) were reported in the literature. For TEVAR patients, the endoleak, stent migration, and reintervention rates were 7.4% (95% CI=0.03%-0.13%), 0.2% (95% CI=0.00%-0.06%), and 17.1% (95% CI=0.01%-0.45%), respectively. The 30-day mortality was 0.9% (95% CI=0%-0.12%). CONCLUSIONS: Endoanchor fixation in EVAR and TEVAR is effective and safe in preventing and treating endoleak and stent migration. The mortality is minimal in EVAR but higher in TEVAR. CLINICAL IMPACT: Endoleak, graft migration, and reintervention in EVAR and TEVAR with endoanchor use were rare. Mortality in EVAR was low. The adjunctive deployment of endoanchors is an effective and safe means to prevent and treat endoleak and stent migration in EVAR and TEVAR. Yet, long-term efficacy and safety data and randomized controlled trials would be required to definitively recommend endoanchor use in routine clinical practice.

The effect of actuation frequency on clot integration with the Tigertriever device: A preliminary in vitro study.

BACKGROUND: The Tigertriever stent retriever (Rapid Medical) can be actively expanded and contracted by the operator, which allows for several actuation-related parameters to be optimized to potentially improve device efficacy. These parameters have not yet been evaluated. We conducted a benchtop study to evaluate the effect of actuation frequency on clot integration within the stent. METHODS: A Tigertriever 17 device was deployed within a biological clot analog placed in a straight tube. The device was actuated between the maximally contracted and maximally expanded states with three different frequencies: passive (one-time opening, n = 6), slow (20 s/cycle, n = 6), and fast (5 s/cycle, n = 7). A flat-detector CT scan was acquired, the clot and stent wires were segmented, and the boundaries of the clot and stent wires were calculated on each axial slice. The intersection between the stent and clot boundaries throughout the volume was defined as the volume of clot integrated within the stent. The clot integration factor (ratio of integrated clot volume to total clot volume) was then statistically compared between the three frequencies as an estimate of clot capture efficiency. RESULTS: The clot integration factor was significantly higher (23% increase, p = 0.01) with the fast actuation as compared to the passive and slow actuations, with a post hoc test showing no difference (p > 0.05) between the passive and slow groups. CONCLUSIONS: Faster actuation frequencies may result in improved clot integration with the Tigertriever device. This effect needs to be validated by clinical data.

Effect of theophylline on stent-related symptoms in patients undergoing Double-J ureteral stent insertion: a randomized controlled trial.

PURPOSE: To investigate the effect of oral theophylline on stent-related syndrome (SRS) after Double-J insertion. BACKGROUND: Double-J stent is widely using in many urological procedures. Infection, hematuria, and discomfort are some of common complication after stenting. Theophylline is a dimethylated xanthine that inhibits phosphodiesterase and blocks adenosine receptors. To relaxing effect of theophylline on smooth muscles and its effects on the urinary system, it seems it could reduce complications after inserting Double-J stent especially ureteral stent syndrome. METHOD: In this double-blind placebo-controlled randomized clinical trial, 67 patients were enrolled. Mean (SD) age of control and theophylline group was 51.8 (12.5) and 43.9 (10.4) years old, respectively. Patients were randomized into two groups of control and theophylline. All patients were stenting with silicon Double J. Theophylline group received 100 mg of theophylline, twice daily for 30 days, while control group received placebo. Stent symptoms were assessed by questionnaire and urine culture was performed before stent removal at removal day. Statistical analysis was performed using Chi-squared test and t test with P < 0.05 considered significant. Logistic regression models were fitted, crudely and adjusted for age and sex. RESULT: Of 67 eligible patients, 60 completed the study. Theophylline significantly decreased percentages of gross hematuria (P < 0.001), dysuria (P < 0.001), and urinary frequency (P < 0.001). Microscopic hematuria (P = 0.042) and chills (P = 0.042) also decreased after theophylline. CONCLUSION: Theophylline could be an effective and safe choice for reducing SRS among patients undergoing Double-J stent insertion.