Balloon-expandable Stent Research Articles

Abstract 4145821: Serial Vascular Responses of Balloon-expandable Stent with Biodegradable Film-type Graft in a Rabbit Iliac Artery Dissection Model (BioGard Study)

Introduction and Background: Arterial dissection during endovascular therapy rarely occurs but can be lethal. A significant blood volume extravasation during coronary artery interventions is related to the very high mortality (20-30%). In this hyperacute emergent clinical situation, covered stents have been considered as a primary measure to prevent further serious arterial events. A fabric-based covered graft stents yield poor clinical outcomes. To overcome these challenges, the balloon-expandable stent with biodegradable film-type graft for treating arterial dissection was invented. Research Questions and Objectives: A novel balloon-expandable stent with biodegradable film graft for overcoming these issues would be valid for efficacy and safety in a rabbit iliac artery dissection model. Method and Approach: Eighteen iliac artery dissections were induced by balloon over-inflation on angiography (Ellis type 2 or 3) and treated using the test device (3.0 x 24 mm). Subsequently, twelve animals underwent histologic examinations and micro-computed tomography (CT) at 0, 2, 4, and 8 weeks and 3, 6, 9, and 12 months and angiography at one-year. Results and Data: There were no adverse cardiovascular events during the one-year. Early-stage histologic examination revealed complete sealing of disrupted vessels by the device, exhibiting mural hematoma, peri-stent red thrombi, and dense infiltration of inflammatory cells. Mid- and long-term histologic examination showed patent stents with neointimal hyperplasia over the stents (% area stenosis: 11.8 at 2weeks, 26.1 at 1month, 29.7 at 3months, 49.2 at 9months, and 51.0 at 1year), along with mild peri-strut inflammatory response (Grade: 1-2 at mid-term and 0-1 at long-term). The graft film became scarcely visible after six months. Both CT and angiography revealed no instances of thrombotic occlusion or in-stent restenosis (% diameter stenosis: 5.7 at 2weeks, 12.3 at 1month, 14.2 at 3months, 25.1 at 9months, and 26.6 at 1 year). Conclusion: The novel balloon-expandable stent with a biodegradable film graft demonstrates feasibility in managing severe artery dissection and preventing lethal vascular events in animal model. Future human studies are warranted to validate these findings and elucidate the clinical outcomes of the study.

Abstract 4118076: Right Innominate Artery Endovascular Intervention Via Single Radial Access and Use Of Embolic Protection

Introduction: The occurrence of innominate artery stenosis is less prevalent compared to subclavian artery disease. Small studies suggest up to 8% of individuals initially diagnosed with suspected subclavian steal syndrome may present with innominate artery lesions. Deployment of an embolic protection filter within the internal carotid artery during percutaneous intervention of the innominate artery presents a solution to mitigate embolism. Case: A 70-year-old female with a history of peripheral vascular disease presented with claudication in both arms, manifested as pain in both arms. Her left subclavian was stented months prior to presentation. An aortogram revealed severe stenosis of the innominate artery (Figure 1). Since multiple attempts to cross the lesion antegrade from the femoral access site were unsuccessful, we proceeded with the successful deployment of an embolic protection filter in the right internal carotid artery via our right radial artery access site (Figure 2). Using the right radial artery, we passed a long run-through guidewire into the distal abdominal aorta. Due to severe aortic tortuosity, we were unable to snare the wire from the aorta. Therefore, we upsized the radial sheath to 7 French over both wires (runthrough and bare). Using a support catheter, we exchanged the runthrough wire for a Glidewire Advantage. We advanced an 8 x 29mm balloon expandable stent to the area of innominate stenosis and deployed it (Figure 3). We postdilated the stent with a 14mm balloon. Angiography demonstrated adequate expansion. On follow up, the patient was without claudication and had triphasic flow in the innominate and left subclavian arteries. Discussion: Treating innominate artery stenosis via radial access employing a sole entry point for both embolic protection and treatment administration offers a substitute where additional access is infeasible. Modern embolic protection techniques are superior due to their flexibility and ease of use. In this case, placing the embolic protection device in the carotid artery was mandatory through the sole radial access to prevent trapping the filter behind the innominate artery stent. We were able to perform both the embolic device placement and the stenting with the same radial access. Conclusion: Endovascular intervention of innominate artery stenosis via radial access, utilizing a single radial access for both embolic protection and treatment delivery, presents an alternative when femoral access is not feasible.

Symptomatic Severe Stenosis of Cavernous Internal Carotid Artery Stenting: A Case Report with Short Literature Review

AbstractIntracranial internal carotid artery (ICA) stenosis is rarely reported as compared with extracranial ICA stenosis. Atherosclerosis is one of the major beginnings of stenosis of vasculatures, which may lead to ischemic stroke causing morbidity and mortality. We report the case of a 60 -year-old man presented to us with complaints of multiple episodes of dizziness, mild headache, and transient left arm weakness for 3 months and had history of smoking, hypercholesterolemia (high level of low-density lipoprotein level = 220 mg/dL), diabetes mellitus, and hypertension under medication. No neurological deficits were observed at the time of admission. Patient underwent angioplasty and stenting with drug-eluting balloon-expandable coronary stent. Patient was discharged well at the 3rd day of procedure. No recurrence of stroke and restenosis were noted till 3 months of follow-up period. Stenting following angioplasty for treatment of symptomatic severe cavernous ICA stenosis with everolimus-eluting coronary balloon-expandable stent, Xience Xpedition, is safe and effective.

Reverse cardiac remodeling induced by endovascular treatment of coarctation of the aorta

Abstract Background Previously, we have showed the 3-year clinical safety and efficacy of balloon expandable versus self-expandable stents in native coarctation of the aorta (CoA) in a randomized clinical trial (RCT). Very few prospective studies have addressed the changes of echocardiographic parameters in mid to long-term follow up of CoA patients treated endovascularly. Purpose We aimed to demonstrate the improvement of echocardiographic parameters among patients undergoing coarctoplasty with stent based on core laboratory-confirmed baseline and 3-year follow up transthoracic echocardiographic (TTE) images. Methods In the index RCT, adult patients with de novo native CoA were randomized into two groups based on stent types. All randomized patients received the 3-year structural follow-up including aortic CT angiography and TTE. The current prospective cohort substudy, included all patients with available baseline and three-year core laboratory TTEs. Results Of 92 patients initially randomized, 71 participated in the 3-year structural follow up. No baseline core lab images were available in 39 patients, and thus, 32 patients (a median age of 32 (24.8 – 37.5) years, (14 women [43.8%]) were included in this subgroup study. One out of the 32 patients presented with recoarctation which was successfully treated before the 3-year evaluation. Peak systolic gradient and end-systolic velocity of the coarctation stenting site were 17.38 ± 6.55 mmHg and 0.93 ± 0.24 m/s respectively in the 3-year follow-up. Septal E’ and lateral E’ velocities were improved significantly (8.6 ± 1.73 cm/s to 9.35 ± 2 cm/s, P = 0.02 and 12.74 ± 2.96 cm/s to 13.92 ± 2.44 cm/s, P = 0.03, respectively). In addition, septal E/E’ ratio (10.84 ± 2.83 to 9.21 ± 3.17, P = 0.02) and lateral E/E’ ratio (7.39 ± 2.24 to 6.29 ± 1.97, P = 0.02) showed significant improvement. Significant reduction in LV mass [160 (130–203) g to 142 (IQR= 121–172) g, P = 0.001], and septal and posterior LV thicknesses were also demonstrated (0.9 (0.8–1.0) cm to 0.81 (0.77–0.93) cm, P = 0.004) and 0.92 ± 0.14 cm to 0.85 ±0.09 cm, P = 0.01, respectively). Twelve (37.5%) patients had baseline LVH which was normalized in 9 (75%). Lastly, 12 (41.3%) of our population had diastolic dysfunction at baseline study which significantly decreased to 4 (13.7%) in the three-year follow-up evaluation. Conclusion In the present core laboratory-based study, coarctoplasty with stent has favorable effects on diastolic function and LV hypertrophy during midterm follow-up in adult population with de novo native aortic coarctation treated with stent.

Mid-Term Outcomes of the Iliac Branch Endoprosthesis with Standardized Combinations of Bridging Stent-Grafts for Endovascular Treatment of Aortoiliac Disease with or Without Co-existing Hypogastric Aneurysms (The HYPROTECT Study).

To evaluate retrospectively the 2-year outcomes of the Gore Excluder Iliac Branch Endoprosthesis (IBE) in patients with and without coexisting hypogastric artery (HA) aneurysms in a large contemporary multicentric European experience using dedicated bridging devices. The study included all consecutive patients treated at participating institutions with the Gore Excluder IBE device who received a covered stent (i.e., stent-graft) from the same manufacturer. Technical success was defined as deployment of endografts with complete exclusion of the aneurysm(s), patency of target vessels, and absence of type 1 and 3 endoleak. Assessment of follow-up outcomes included freedom from HA branch instability defined as the composite cumulative endpoint of any HA branch-related complication. A total of 437 patients were included for analysis from 22 European vascular surgery centers. Patients were categorized into two subgroups: subgroup A (n = 269) if they did not have concomitant hypogastric aneurysms, otherwise they were categorized into subgroup B (n = 168). Finally, 78 (18%) had bilateral IBE with a total of 515 IBE included in the study. Balloon expandable stents were deployed in 19 (6.3%) subgroup A patients compared with 46 (21.7%,) in subgroup B, p < .001. The two-year estimate for freedom of HA branch instability was significantly higher for patients in group A as compared with patients in group B (94% vs. 90%, p = .045). At univariate regression, the number of stent-grafts used was associated with higher risk of iliac branch instability (p = .021), while in multivariate regression for the use of more than 2 bridging stent-grafts the risk of instability increased by 2.35 times. This large contemporary European multicentric experience with the use of the Gore Excluder IBE in patients with or without associated HA aneurysms shows satisfactory mid-term outcomes when the device is used in conjunction with both self-expandable and balloon-expanding stent-grafts from the same manufacturer. Although primary patency of the iliac branch was as high as 90%, caution and strict follow-up must be exercised when multiple bridging stent-grafts are used over longer distances.

Endovascular treatment of aortic coarctation using covered balloon-expandable stents-a systematic review and meta-analysis.

Balloon dilation followed by balloon-expandable stent implantation is an effective treatment for improving hemodynamic status in patients with coarctation of the aorta (CoA). However, limited evidence exists regarding the safety and efficacy of covered balloon-expandable stents (CBSs) in a large cohort. In this meta-analysis, we aimed to evaluate the overall success rates, hemodynamic and anatomical benefits, complications, and mid-term results of CBSs in treating CoA. The PubMed, Embase, and Cochrane Library databases were systemically searched for studies reporting outcomes of CBSs in treating CoA. Single-group rate meta-analyses were performed to calculate estimated pooled procedural success rates, the incidence of complications, and re-coarctation rates. A meta-analysis using standardized mean differences was conducted to compare pre- and postoperative trans-coarctation pressure gradients (PGs), coarctation diameter, and overall changes in systolic blood pressure (SBP). Subgroup analyses were performed to identify potential sources of heterogeneity. The final analysis included 12 studies with a total of 411 patients. The estimated pooled procedural success rate was 100% [95% confidence interval (CI): 98%-100%, I2 = 0, P = 0.78]. Significant decreases in trans-coarctation PGs and SBP were observed. The pooled incidences of stent-related, aortic, and access site complications were 2% (95% CI: 0%-5%, I 2 = 30.4%, P = 0.15), 2% (95% CI: 0%-4%, I 2 = 0%, P = 0.76), and 3% (95% CI: 1%-7%, I 2 = 52.9%, P = 0.02), respectively. Subgroup analyses showed that implantation of BeGraft stents was related to a significantly higher incidence of access site complications. Covered balloon-expandable stent implantation in treating CoA is safe and effective with high procedural success rates, an acceptable incidence of complications, and a low incidence of re-coarctation. https://www.crd.york.ac.uk/PROSPERO/, PROSPERO (CRD42023430356).

Hybrid Stent Graft Technique in Bridging Hostile Renal Arteries in Thoraco-abdominal Branched Endografting

Patency of target arteries is crucial for fenestrated and branched endovascular aortic repair (F/B-EVAR) in thoracoabdominal aortic aneurysms (TAAAs). Occlusions more frequently occur in renal arteries (RAs) than in coeliac and superior mesenteric arteries, especially in patients with hostile anatomy treated by BEVAR. This study aimed to report RA outcomes using a hybrid bridging stent graft technique with distal self expandable (SE) combined with proximal balloon expandable (BE) stent graft during BEVAR with hostile RA anatomies. Clinical data from consecutive patients treated for TAAA by F/B-EVAR in three aortic centres (two in the USA, one in Europe) from 2016 to 2022 were prospectively collected. Renal artery orientation was defined as hostile in case of upward (type B) or downward + upward (type D) orientation. Hostile RAs accommodated by BEVAR and combination of SE + BE stent grafts were retrospectively evaluated. Intra-operative RA related complications, technical success, and branch occlusions were assessed as early outcomes. Primary and secondary RA patency, freedom from RA related re-interventions, and freedom from RA instability were assessed during follow up. Of 584 TAAAs managed by F/B-EVAR, 83 patients (14.2%) had 125 hostile RAs (type B, 45.6%; type D, 54.4%) managed by BEVAR with hybrid SE + BE stent grafts. Intra-operative complications occurred in three RAs (2.4%), including two dissections and one disconnection, all successfully managed with additional stent. Technical success was achieved in all cases, with no RA occlusions at 30 days. The median follow up was 21 (interquartile range 4, 38) months. Estimated three year RA primary patency was 97 ± 2%. Re-interventions were performed in five RAs (4.0%), including two RA branch embolisations for bleeding, two catheter thrombectomies with stent relining (bilateral occlusion in one patient), and one revision of type Ic endoleak. Freedom from RA related re-interventions and RA instability was 95 ± 2% and 91 ± 3% at three years, respectively. Renal artery secondary patency was 99 ± 1% at three years. In hostile RA anatomies, a combination of distal SE and proximal BE stent grafts as bridging stenting in BEVAR is safe and effective, with low rates of occlusion, re-interventions, and branch instability at midterm follow up.

Interaction of a self-expandable stent with the arterial wall in the presence of hypocellular and calcified plaques.

Self-expandable stents manufactured from nitinol alloys are commonly utilized alongside traditional balloon-expandable stents to provide scaffolding to stenosed arteries. However, a significant limitation hampering stent efficacy is restenosis, triggered by neointimal hyperplasia and resulting in the loss of gain in lumen size, post-intervention. In this study, a nonlinear finite element model was developed to simulate stent crimping and expansion and its interaction with the surrounding vessel in the presence of a plaque. The main aim was to determine contact pressures and forces induced at the interface between an artery wall with hypocellular and calcified plaques and an expanded stent. The results demonstrated the drawbacks of plaque calcification, which triggered a sharp contact pressure and radial force surge at the interface as well as a significant rise in von Mises stress within the vessel, potentially leading to rupture and restenosis. A regression line was then established to relate hypocellular and calcified plaques. The adjusted coefficient of determination indicated a good correlation between contact pressures for calcified and hypocellular plaque models. Regarding the directionality of wall properties, contact pressure and force observations were not significantly different between isotropic and anisotropic arteries. Moreover, variations in friction coefficients did not substantially affect the interfacial contact pressures.

Interventional retrieval of a balloon-expandable stent in an infant following tetralogy of Fallot repair.

Interventional retrieval of a balloon-expandable stent in an infant following tetralogy of Fallot repair.

Pulmonary Artery Endograft Implantation Using a Parallel Stent Grafting Technique to Enable the Treatment of a Bronchial Anastomosis Complication After Lung Transplantation.

Bronchial stenosis associated with bronchial anastomosis dehiscence after lung transplantation is a catastrophic complication following lung transplantation with a paucity of therapeutic solutions. To describe an adaptation of the parallel stent grafting technique in the pulmonary arterial territory to treat this challenging situation. This is a case report of a 52-year-old patient who presented bronchus stenosis and bronchial anastomosis dehiscence after lung transplantion. Bronchial stenting and lung retransplantation were contraindicated. Therefore, an endovascular approach using pulmonary artery endograft placement to prevent bleeding during repeated right bronchial balloon dilation was propposed. The technique consists of the deployment of an aortic extender endoprosthesis in the right main pulmonary artery and a balloon expandable stent in the upper lobe pulmonary artery (using a parallel graft configuration) through the common femoral and right internal jugular veins, respectively. Intraoperative transesophageal echocardiogram and one-lung ventilatory ventilation are needed. The patient underwent a new bronchoscopy 16 days after the procedure, that showed epithelization at the previous eroded zone, enabling bronchocopic balloon dialtion to be safely performed. A post-operative contrast-enhanced CT scan revealed an adequate positioning of the stent grafts. Despite all eforts, the patient succumbed to ventilator associated pneumonia on postoperative day 108. The technique's advantages include its feasibility even in situations in which other techniques may be contraindicated and its potential use in emergencies. Its limitations include the need for experienced interventionists to perform it, and the potential risk of acute tricuspid regurgitation. This study illustrates the early feasibility of the parallel stent grafting technique applied to the pulmonary artery territory. However, it's safety profile regarding infectious risk was not demontrated.

Effects of Fe addition on the mechanical and corrosive properties of biomedical Co-Cr-W-Ni alloys for balloon-expandable stents

Co-20Cr-15W-10Ni (mass%, CCWN) alloy is extensively used as a platform material for balloon-expandable stents. In this study, the mechanical properties of CCWN alloy are improved following the addition of Fe, and the effects of Fe addition on the mechanical and corrosive properties of the alloy are investigated. As-cast specimens were fabricated by adding pure Fe to a commercially available CCWN alloy (base alloy) such that the resulting alloys contained 4, 6, and 8 mass% Fe. The as-cast specimens were subjected to homogenization heat treatment at 1523 K for 7.2 ks and then hot-forged at 1473 K (as-forged specimens). The as-forged specimens were cold-rolled at a reduction rate of 30% and heat-treated at 1473 K for 300 s (recrystallized specimens). The matrix of the recrystallized base- and Fe-containing alloys consisted of a single γ (face-centered cubic)-phase. The Fe-added alloys revealed precipitates composed of the η-phase (M6X-M12X-type phase, M: metallic element, X: C and/or N). The average grain size of the recrystallized base and Fe-added alloy specimens was approximately 34 μm and the amount of added Fe had no significant effect on the static recrystallization behavior of the resulting alloys. Alloys containing 6 mass% or more Fe showed improvements in strength and ductility compared with the base alloy. When the Fe-added alloys were compared, their strength decreased whereas their ductility increased when the added Fe increased. Because Fe acts as a γ-phase-stabilizing element for Co, Fe addition increases the stacking fault energy of the base alloy, resulting in the formation of the ε (hexagonal close-packed)-phase owing to the suppression of strain-induced martensitic transformation (SIMT), and improvements in ductility. No deterioration in corrosion resistance was observed following the addition of up to 8 mass% Fe to the base alloy. Based on these results, the addition of Fe to CCWN alloy may be considered an effective method to improve its mechanical properties, especially ductility, without impairing its corrosion resistance. The results of this study will be useful for the future development of Ni-free Co-Cr alloys for next-generation, small-diameter stents.

Evaluation of balloon and self-expandable stents for common femoral artery stenosis

BackgroundEndovascular treatment of the common femoral artery (CFA) and its bifurcation is currently recommended for patients with hostile groin (prior femoral bifurcation open surgery, history of radiotherapy) or severe comorbidities (advanced age, frailty, obesity). Preliminary results have shown favorable outcomes. Among the different endovascular techniques (atherectomy, intravascular lithotripsy, plain balloon angioplasty, drug-coated balloon angioplasty, stenting), stents are mainly used but the best type of stent to use is still debated. The aim of this study was to assess the value of balloon-expandable stents (BES) and self-expandable stents (SES) for stenosis of the femoral bifurcation. MethodsConsecutive patients with stenosis of the CFA and its bifurcation were included from 2016 to 2022. Demographic data, the type of stent used, procedural data, and angiographic variables were collected. Groups were defined according to the type of stent implanted. Primary patency was defined as a binary end point based on a duplex ultrasound peak systolic velocity ratio of ≤2.4 as assessed by duplex ultrasound examination, in the absence of clinically driven target lesion revascularization (TLR) or bypass of the target lesion. Secondary outcomes were clinical sustained improvement, freedom from TLR at 12 months, mean ankle-brachial index improvement, primary-assisted patency, and secondary patency. ResultsA total of 90 procedures conducted in 77 patients were included in this study, 26 in the SES group and 64 in the BES group. The most common symptomatology according to the Rutherford classification was class 2, 3, and 4 (28%, 48%, and 8%, respectively). The type of lesions in the CFA, assessed using the Azema classification, were comparable between both groups (SES/BES group type 2: 31%/27%; type 3: 54%/62%). At 12 months, the primary patency rates for SES and BES were 88% (26/26 patients) and 72% (58/64 patients) (P = .10). At 12 months, freedom from TLR rates for SES and BES were 97% vs 81%, respectively (P = .13). ConclusionsSES for CFA stenosis show a trend toward better patency and freedom from TLR rates at 12 months. However, controlled studies are warranted to further investigate the significance of this trend.

Transcatheter stenting of superior vena cava to treat postoperative SVC syndrome in a child: a case report

BackgroundSuperior vena cava (SVC) obstruction leading to SVC syndrome is an uncommon but potential complication of cardiac surgeries that involve dissection and anastomosis around the great vein. We present a case of iatrogenic SVC obstruction that was initially treated with transcatheter balloon angioplasty, which provided temporary relief, and ultimately resolved by stenting the affected segment.Case presentationThe index case underwent total anomalous pulmonary venous connection (TAPVC) repair and presented 3 months after surgery with features of SVC obstruction. Initially, transcatheter balloon angioplasty was performed, providing relief from the obstruction; however, the condition recurred within one month. Finally, the patient was treated with percutaneous stenting of superior vena cava, through femoral venous route, using 8 mm × 30 mm balloon-expandable bare metal stent (Formula 418, Cook Medical, Bloomington, IN). Remarkable relief of obstruction was established with decrease in mean gradient across SVC–right atrium junction to 2 mm Hg (from 12 mm Hg before balloon angioplasty and 18 mm Hg before stenting).ConclusionPercutaneous treatment for iatrogenic SVC obstruction developing after cardiac surgery appears to be effective. Close monitoring is required in the postoperative period for early diagnosis and timely intervention.

Skin Adhesive Tapes: An Effective Wound Closure Method for Percutaneous Vertebral Body Stenting.

Background Skin adhesive tapes (SATs) are hypoallergenic adhesive tapes commonly used for wound closure in percutaneous vertebroplasty (PVP). Vertebral body stenting (VBS) is a metallic balloon-expandable stent used to treat vertebral body fractures. Its balloon and stent deployment involves a larger stab incision and pedicle bore tract than PVP, increasing the risk of bleeding and wound complications. This study evaluated the outcome and complications of VBS wound closure with SAT and the reasons for conversion to conventional suture closure (SC). Material and methods A retrospective series of patients who underwent VBS from May 2019 to March 2021 were identified from review of computerized medical records. Data were collected for wound closure method, reason for SC, number of operative levels, postoperative wound complications of contact dermatitis, tension blisters, tape dislodgement, surgical site infection, wound dehiscence, symptomatic hematoma and return to operating theater. The wounds were assessed for complete healing and cosmesis at outpatient follow-up visits. Results A total of 36 patients were identified. SAT closure was performed in 33 (91.6%) patients, while SC was performed in three (8.3%) patients. Unplanned conversion to SC was required in two (5.5%) patients due to continued intraoperative wound bleeding, while one (2.7%) patient had planned SC as part of a staged operation. Uneventful closures occurred in 32 (97.0%) of SAT closures. One (3%) SAT closure patient developed postoperative blood-soaked dressings and tape dislodgement, requiring reapplication of the SATs at the ward with uneventful recovery thereafter. No patient with SAT closure developed contact dermatitis, tension blisters, surgical site infection, wound dehiscence, symptomatic hematoma, or required return to theater. All SAT closure patients had complete wound healing at outpatient follow-up at six weeks. No SAT closure was found to be cosmetically unacceptable or required wound revision for any reason at up to one year postoperatively. Conclusion SATs are a safe and reliable means of wound closure for VBS. Conversion to SC due to continued intraoperative wound site bleeding is rarely required.

Newly Designed, Self-Expanding Large-Bore Nitinol Stents for Symptomatic Central Venous Stenosis: Technical and Long-Term Clinical Outcome.

To retrospectively analyze the technical and long-term clinical outcome of angioplasty and stenting using the Venovo™ venous stent for the treatment of malignant and benign superior vena cava (SVC) occlusive disease. Consecutive patients treated with the Venovo™ venous stent for SVC occlusive disease were included. SVC obstruction symptoms were classified according to the Kishi score. The Wilcoxon signed-rank test was used for testing significance of changes. Technical success, defined as correct placement of the stent, completely covering and re-expanding the obstruction, between groups was tested using the Fisher exact test. Overall survival was calculated using the Kaplan-Meier method. Fifty-five patients underwent stent insertion for symptomatic benign (n = 13; 24%) or malignant (n = 42; 76%) SVC occlusive disease. A significant drop in Kishi score, mean 3.91 before versus mean 1.02 after the procedure (P < 0.0001), was observed. In one patient (1.8%), an additional balloon-expandable stent was needed to manage incomplete expansion of the nitinol stent. In one patient, a procedure-related lung embolic complication was noted. Early thrombotic occlusion of the stent occurred in one patient. Late symptomatic restenosis occurred in 3 patients. Overall primary stent patency and primary-assisted stent patency were 86% (95% CI 66-95) and97% (95% CI 83-100) at 1-year follow-up and 98% (95% CI 87-100), 98% (87-100) at 2-year follow-up, respectively. In this retrospective analysis, angioplasty and stent placement using the Venovo™ venous stent is safe and clinically effective for the treatment of both benign and malignant SVC occlusive disease. Reintervention for symptomatic restenosis is rare.

Comparative Efficacy and Safety of Self-Expandable vs. Balloon-Expandable Stent Grafts in Visceral Artery Aneurysm Management.

This study assesses the efficacy and safety of self-expandable (SE) versus balloon-expandable (BE) stent grafts for managing visceral artery aneurysms (VAAs), focusing on procedural success and complication rates. We conducted a retrospective analysis of VAA patients treated at our institution from April 2006 to September 2021. The study reviewed patient demographics, aneurysm characteristics, treatment details, and outcomes, including endoleaks. Among the 23 patients analyzed, splenic artery aneurysms represented 44% of cases. Fifteen patients were treated with balloon-expandable stent grafts (BE SGs), and eight patients were treated with self-expandable stent grafts (SE SGs). For saccular aneurysms, the average neck size was 10.10 ± 8.70 mm in the BE group versus 18.50 ± 3.40 mm in the SE group (p = 0.23), with an average sac size of 20.10 ± 18.9 mm in the BE group versus 15.60 ± 12.7 mm in the SE group (p = 0.16). The average sac-to-neck ratio was 1.69 ± 2.23 in the BE group versus 1.38 ± 0.33 in the SE group (p = 0.63). The BE group exhibited a significantly higher endoleak rate (60%) compared to the SE group (12.5%; p = 0.03). While further investigation is needed to fully assess the outcomes of stent graft treatment for VAAs, initial data show a significantly higher endoleak rate with BE SGs compared to SE SGs. The SE SGs may offer better outcomes due to their superior ability to conform to tortuous and mobile visceral arteries.

The Gore Viabahn balloon-expandable stent graft as a bridging stent in complex endovascular aortic procedures at 3 years performs better in fenestrations

ObjectiveComplex endovascular procedures are now recognized as the gold standard treatments for extensive aortic diseases. Bridging stents (covered stents used to couple the aortic graft to the visceral vessels) play a pivotal role, yet there is currently no dedicated device available on the market. The aim of the study was to evaluate the midterm performance of the Gore Viabahn balloon-expandable (VBX) stent graft as a bridging stent for target visceral vessels (TVVs). MethodsData from all consecutive patients who underwent a fenestrated and branched endovascular aortic repair and received the VBX stent graft as a bridging stent between July 2018 and September 2022 were prospectively collected and subsequently analyzed retrospectively. Primary end points included freedom from TVV instability and freedom from TVV-related reinterventions, both overall and in comparison between branched and fenestrated graft configurations. Secondary end points were overall survival, procedure and TVV-related (in an intent-to-treat basis) technical success, freedom from type IC/IIIC endoleak, and freedom from TVV patency loss. ResultsSixty-three patients were treated with a fenestrated and branched endovascular aortic repair using the VBX stent graft as a bridging stent, of whom 47 (74.6%) presented an atherosclerotic aneurysm, 7 (11.1%) a post-dissecative aneurysm, and 9 (14.3%) an anastomotic pseudoaneursym or a type IA endoleak in a previous endovascular aortic repair. Included in the aortic repair were 231 of 243 (95.1%) total visceral vessels. The intraoperative requirement of 13 additional VBX stent grafts determined a TVV-related technical success of 94.4%. The mean follow-up was 26.1 ± 16.4 months. The estimated overall survival at 36 months was 73% ± 7.5%. The estimated rates at 36 months for freedom from type IC/IIIC endoleaks and TVV primary patency were 90.6% ± 3.9% and 99% ± 0.7%, respectively. The estimated rate at 36 months for freedom from TVV instability was 92.1% ± 3% and did not differ between branched and fenestrated configurations, whereas freedom from TVV-related reinterventions was 90.6% ± 3.1% and significantly in favor of fenestrations (69.4% vs 96.8%, P < .001). Multivariate analyses confirmed fenestrated configuration as a protective factor against TVV-related reinterventions (hazard ratio: 0.079; 95% confidence interval: 0.016-0.403). ConclusionsThe VBX stent graft proves to be a reliable bridging stent for complex aortic procedures involving both fenestrated and branched endografts. Although immediate results are deemed satisfactory, they favor fenestrations regarding the need of reinterventions through 3 years. The success of the procedure heavily relies on a thorough understanding of the unique characteristics of this stent.

Weaning failure due to isolated residual diaphragmatic paralysis after cervical spinal cord ischemia following aortic surgery- a case report

BackgroundBilateral diaphragmatic dysfunction can lead to dyspnea and recurrent respiratory failure. In rare cases, it may result from high cervical spinal cord ischemia (SCI) due to anterior spinal artery syndrome (ASAS). We present a case of a patient experiencing persistent isolated diaphragmatic paralysis after SCI at level C3/C4 following thoracic endovascular aortic repair (TEVAR) for Kommerell’s diverticulum. This is, to our knowledge, the first documented instance of a patient fully recovering from tetraplegia due to SCI while still exhibiting ongoing bilateral diaphragmatic paralysis.Case presentationThe patient, a 67-year-old male, presented to the Vascular Surgery Department for surgical treatment of symptomatic Kommerell’s diverticulum in an aberrant right subclavian artery. After successful surgery in two stages, the patient presented with respiratory insufficiency and flaccid tetraparesis consistent with anterior spinal artery syndrome with maintained sensibility of all extremities. A computerized tomography scan (CT) revealed a high-grade origin stenosis of the left vertebral artery, which was treated by angioplasty and balloon-expandable stenting. Consecutively, the tetraparesis immediately resolved, but weaning remained unsuccessful requiring tracheostomy. Abdominal ultrasound revealed a residual bilateral diaphragmatic paralysis. A repeated magnetic resonance imaging (MRI) 14 days after vertebral artery angioplasty confirmed SCI at level C3/C4. The patient was transferred to a pulmonary clinic with weaning center for further recovery.ConclusionsThis novel case highlights the need to consider diaphragmatic paralysis due to SCI as a cause of respiratory failure in patients following aortic surgery. Diaphragmatic paralysis may remain as an isolated residual in these patients.

Balloon-expandable cobalt chromium stent versus self-expandable nitinol stent for the Atherosclerotic Iliac Arterial Disease (SENS-ILIAC Trial) Trial: a randomized controlled trial.

Iliac artery angioplasty with stenting is an effective alternative treatment modality for aortoiliac occlusive diseases. Few randomized controlled trials have compared the efficacy and safety between self-expandable stent (SES) and balloon-expandable stent (BES) in atherosclerotic iliac artery disease. In this randomized, multicenter study, patients with common or external iliac artery occlusive disease were randomly assigned in a 1:1 ratio to either BES or SES. The primary end point was the 1-year clinical patency, defined as freedom from any surgical or percutaneous intervention due to restenosis of the target lesion after the index procedure. The secondary end point was a composite event from major adverse clinical events at 1year. A total of 201 patients were enrolled from 17 major cardiovascular intervention centers in South Korea. The mean age of the enrolled patients was 66.8 ± 8.5years and 86.2% of the participants were male. The frequency of critical limb ischemia was 15.4%, and the most common target lesion was in the common iliac artery (75.1%). As the primary end point, the 1-year clinical patency as primary end point was 99% in the BES group and 99% in the SES group (p > 0.99). The rate of repeat revascularization at 1year was 7.8% in the BES group and 7.0% in the SES group (p = 0.985; confidence interval, 1.011 [0.341-2.995]). In our randomized study, the treatment of iliac artery occlusive disease with self-expandable versus balloon-expandable stent was comparable in 12-month clinical outcomes without differences in the procedural success or geographic miss rate regardless of the deployment method in the distal aortoiliac occlusive lesion (ClinicalTrials.gov, NCT01834495).

Effects of percutaneous endovascular angioplasty for severe stenosis or occlusion of subclavian artery

To investigate the effect and safety of percutaneous endovascular angioplasty (PEA) with optional stenting for the treatment of severe stenosis or occlusion of subclavian artery, patients with severe stenosis ≥ 70% or occlusion of subclavian artery treated with PEA were retrospectively enrolled. The clinical data were analyzed. A total of 222 patients were retrospectively enrolled, including 151 males (68.0%) and 71 females (32.0%) aged 48–86 (mean 63.9 ± 9.0) years. Forty-seven (21.2%) patients had comorbidities. Subclavian artery stenosis ≥ 70% was present in 201 (90.5%) patients and complete subclavian occlusion in 21 (9.5%) cases. Angioplasty was successfully performed in all (100%) patients. Balloon-expandable stents were used in 190 (85.6%) cases, and self-expandable stents in 20 (9.0%) cases. Only 12 (5.4%) cases were treated with balloon dilation only. Among 210 patients treated with stent angioplasty, 71 (33.8% or 71/210) cases underwent balloon pre-dilation, 139 (66.2% or 139/210) had direct deployment of balloon-expandable stents, and 2 (1.0% or 2/210) experienced balloon post-dilation. Distal embolization protection devices were used in 5 (2.3% or 5/222) cases. Periprocedural complications occurred in 3 (1.4%) patients, including aortic dissection in 2 (0.9%) cases and right middle cerebral artery embolism in 1 (0.5%). No hemorrhage occurred. Among 182 (82.0%) patients with 6-month follow-up, restenosis > 70% occurred in 1 (0.5%) patient, and among 68 (30.6%) patients with 12-month follow-up, restenosis > 70% took place in 11 (16.2%) patients. Percutaneous endovascular angioplasty can be safely and efficiently performed for the treatment of severe stenosis ≥ 70% or occlusion of subclavian artery.