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.

Infrarenal Aortic Treatment With AFX2 Endograft: Results From a Multicentric, International, Non-Randomized, Prospective Registry-the AFX2-LIVE Study.

INTRODUCTION: To confirm real-world clinical practice results reported with anatomically fixed bifurcated endograft, a physician-initiated study was designed-AFX2-LIVE registry. MATERIALS AND METHODS: From November 2019 to August 2021, investigators enrolled all consecutive patients treated with AFX2 (Endologix Inc., Irvine, CA, USA) endograft. Patients with abdominal aortic aneurysms (AAAs), penetrating aortic ulcers (PAU), and isolated infrarenal aortic dissections were included. Clinical and anatomical data, including baseline, intraoperative, and in-hospital details, as well as follow-up data, were collected in an anonymized prospectively compiled database. The primary endpoint of this study was to evaluate the technical and clinical success of endovascular aortic repair (EVAR) using AFX2 endograft. RESULTS: A total of 535 patients were enrolled from 43 Italian and Spanish centers and analyzed according to the protocol. Four hundred eighty-nine patients were male (91.4%), with a mean age of 75±8.92 years (range 52-94). Four hundred sixty-six patients (87.1%) were treated for AAA, 49 (9.3%) for PAU, and 20 (3.6%) for isolated abdominal aortic dissection. A proximal extension was needed in 48% of the cases. Assisted technical success was achieved in all but one patient (99.8%). At 30 days follow-up, no AAA-related deaths were recorded, and nine patients (1.6%) required reintervention. At a mean follow-up period of 15.22±13.65 (range 1-53) months, data were available for 479 patients (89.5%). Clinical success was achieved in 98.2% (95% confidence interval [CI]: 96.4-99.1) at 3 months, 93.9% (95% CI: 90.1-96.1) at 1 year, and 74.1% (95% CI: 62.8-82.4) at 4 years follow-up. The estimated freedom from all-cause mortality was 97.7%, 93.4%, 81.6%, 77.5%, and 70.9%, and freedom from AAA-related mortality was 100%, 99.6%, 99.6%, 99.6%, and 97.3% at 3, 12, 24, 36, and 48 months, respectively. Twenty reinterventions (3.7%) were required in 19 patients, of which 3 late open conversions (0.6%) were performed, and 2 AAA-related deaths were observed. CONCLUSION: This study demonstrated excellent clinical and technical success rates of EVAR with anatomically fixed endografts, providing valuable insights into real-world clinical outcomes. CLINICAL IMPACT: The AFX2-LIVE study could have a significant impact by providing robust evidence supporting the effectiveness and safety of EVAR using bifurcated endografts with anatomical fixation in real-world clinical practice, ultimately leading to improved outcomes and enhanced patient care in the management of abdominal aortic pathologies.

The Vascular Quality Initiative assessment of the Bard Lifestent for the treatment of popliteal artery occlusive disease.

OBJECTIVE: The Bard LifeStent self-expanding stent is approved for the treatment of occlusive disease involving the superficial femoral artery and proximal popliteal artery. We conducted a post-market trial of treatment of the popliteal artery above and below the knee (P1, P2, and P3 segments) within the Society for Vascular Surgery Vascular Quality Initiative (VQI) Peripheral Vascular Intervention registry. METHODS: A single-arm, prospective trial was conducted at 29 VQI sites in the United States, enrolling 74 patients from November 2016 to May 2019. The primary safety outcome was freedom from major adverse events including device-/procedure-related mortality and major amputation at 1 year. The primary efficacy outcomes were freedom from target vessel revascularization and freedom from target lesion revascularization at 1 year. Secondary outcomes included lesion success; procedural success; primary, primary-assisted, and secondary patency; and sustained clinical (improvement in Rutherford class) and hemodynamic success (increase in ankle brachial index >0.10). Outcomes were assessed by Kaplan-Meier analysis. Arteriogram of patients undergoing target lesion revascularization were assessed for stent fracture by a core laboratory. RESULTS: The mean age was 71 years, with 63.5% male and 55% with diabetes. The indication was claudication 28% and chronic limb-threatening ischemia in 72%. The superficial femoral artery-popliteal artery was stented in 38% and the popliteal artery alone in 62%. The majority of stents were placed in the P1 + P2 (39%) or P1 + P2 + P3 (37%) segments of the popliteal artery. The composite primary endpoint of freedom from major adverse events was 82% and 74% at 1 and 2 years, respectively. Freedom from mortality was 100% and 97%, and freedom from major amputation was 100% and 90% at 1 and 12 months, with all deaths and major amputations occurring in patients with chronic limb-threatening ischemia. freedom from target lesion revascularization was 86%, and freedom from target vessel revascularization was 84% at 12 months. At discharge, lesion treatment success was 99%, and procedural success was 82%. Primary patency was 80% and 72%, primary-assisted patency was 80% and 72%, and secondary patency was 89% and 82% at 12 and 24 months. Sustained clinical success was 98% and 95%, and sustained hemodynamic success was 100% and 79% at 12 and 24 months. CONCLUSIONS: In this multi-center, registry-based, single-arm prospective study the Bard LifeStent self-expanding stent demonstrated favorable performance in the challenging anatomy of the P2 and P3 popliteal segment. Post-market studies for label expansion of peripheral vascular intervention devices can be successfully conducted within the Society for Vascular Surgery VQI registry.

Novel Self-expanding Shape-Memory Bioresorbable Peripheral Stent Displays Efficient Delivery, Accelerated Resorption, and Low Luminal Loss in a Porcine Model.

OBJECTIVE AND DESIGN: The search for improved stenting technologies to treat peripheral artery disease is trending toward biodegradable self-expanding shape-memory stents that, as of now, still suffer from the acute trade-off between deliverability and luminal stability: Higher deliverability leads to lower lumen stability, vessel recoil, and stent breakage. This study was aimed at the development and testing of a self-expanding bioresorbable poly(l,l-lactide-co-ε-caprolactone) stent that was designed to produce confident self-expansion after efficient crimping, as well as quick bioresorption, and sufficient radial force. MATERIALS AND METHODS: Bench tests were employed to measure shape-memory properties, radial force, and hydrolytic degradation of the stent. The porcine model was employed to study deliverability, lumen stability, biocompatibility, and stent integrity. A total of 32 stents were implanted in the iliac arteries of 16 pigs with 15 to 180 day follow-up periods. The stented vessels were studied by angiography and histological evaluation. RESULTS: Recovery of the diameter of the stent due to shape-memory effect was equal to 90.6% after 6Fr crimping and storage in refrigeration for 1 week. Radial force measured after storage was equal to 0.7 N/mm. Technical success of implantation in pigs (after the delivery implemented by pusher) was 94%. At 180 days, no implanted stents were found to be fragmented: All of the devices remained at the site of implantation with no stent migration and all stents retained their luminal support. Only moderate inflammation and neoepithelialization were detected by histological assessment at 60, 90, 120, and 180 days. Lumen loss at 180 days was less than 25% of the vessel diameter. CONCLUSIONS: The stent with the mechanical and chemical properties described in this study may present the optimal solution of the trade-off between deliverability and luminal stability that is necessary for designing the next generation stent for endovascular therapy of peripheral arterial disease.

Outcomes of the Gore® Excluder® Iliac Branch Endoprosthesis Using Self Expanding or Balloon-Expandable Stent Grafts for the Internal Iliac Artery Component.

OBJECTIVE: The GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, Arizona) was developed to be used in combination with a self-expanding stent graft (SESG) for the internal iliac artery (IIA) bridging stent. Balloon-expandable stent grafts (BESGs) are an alternative for the IIA, offering advantages in sizing, device tracking, precision, and lower profile delivery. We compared the performance of SESG and BESG when used as the IIA bridging stent in patients undergoing EVAR with IBE. METHODS: This is a retrospective review of consecutive patients who underwent EVAR with IBE implantation at a single center from October 2016 to May 2021. Anatomic and procedural characteristics were recorded via chart review and computed tomography (CT) postprocessing software (Vitrea® v7.14). Devices were assigned to SESG vs. BESG groups based on the type of device landing into the most distal IIA segment. Analysis was performed per device to account for patients undergoing bilateral IBE. The primary endpoint was IIA patency, and secondary endpoint was IBE-related endoleak. RESULTS: During the study period, 48 IBE devices were implanted in 41 patients (mean age 71.1 years). All IBE devices were implanted in conjunction with an infrarenal endograft. There were 24 devices in each of the self-expanding internal iliac component (SE-IIC) and balloon-expandable internal iliac component (BE-IIC) groups. The BE-IIC group had smaller diameter IIA target vessels (11.6±2.0 mm vs. 8.4±1.7 mm, p<0.001). Mean follow-up was 525 days. Loss of IIA patency occurred in 2 SESG devices (8.33%) at 73 and 180 days postprocedure, and in zero BESG devices, however, this difference was not statistically significant (p=0.16). There was 1 IBE-related endoleak requiring reintervention during the study period. A BESG device required reintervention due to Type 3 endoleak at 284 days. CONCLUSIONS: There were no significant differences in outcomes between SESG and BESG when used for the IIA bridging stent in EVAR with IBE. The BESGs were associated with using 2 IIA bridging stents and were more often deployed in smaller IIA target arteries. Retrospective study design and small sample size may limit the generalizability of our findings. CLINICAL IMPACT: This series compares postoperative and midterm outcomes of self expanding stent grafts and balloon expandable stent grafts (BESG) when used as the internal iliac stent graft as part of a Gore® Excluder® Iliac Branch Endoprosthesis (IBE). With similar outcomes between the two stent-grafts, our series suggests that some of the advantages of BESG, device sizing, tracking, deployment, and profile, may be able to be leveraged without impacting the mid-term performance of the IBE.

A Case of Complete Resolution of Cauda Equina Syndrome Caused by Extensive Iliocaval Thrombosis: The Role of Thrombolysis and Venous Stents.

PURPOSE: The cauda equina syndrome (CES) is a rare condition affecting less than 1 in 100,000 patients annually. Diagnosing CES is challenging because of its rare incidence, potentially subtle presentation, and various underlying etiologies. Vascular causes, such as inferior vena cava (IVC) thrombosis, are uncommon but should be considered, since timely recognition and treatment of deep vein thrombosis (DVT) as a cause of CES can avoid irreversible neurological damage. CASE REPORT: A 30-year-old male presented with partial CES caused by nerve root compression due to venous congestion from an extensive iliocaval DVT. He completely recovered after thrombolysis and stenting of the IVC. His iliocaval tract remained patent until the last date of follow-up at 1 year without signs of post-thrombotic syndrome. Broad molecular, infectious, and hematological laboratory tests did not reveal any underlying disease for the thrombotic event, particularly no hereditary or acquired thrombophilia. CONCLUSION: Timely recognition of venous thrombosis as a cause of CES is essential. This is the first case report of CES caused by an extensive iliocaval DVT successfully treated with thrombolysis and venous stenting with good resolution of DVT and CES. CLINICAL IMPACT: This case-report describes a patient with cauda equina syndrome resulting from an extensive iliocaval deep vein thrombosis due to an underlying stenosis of the inferior vena cava. Thrombolysis and venous stenting succesfully restored venous patency and thereby relieved symptoms and signs of cauda equina syndrome, in addition to (long-term) therapeutic dose anticoagulation. It is important to timely recognize deep vein thrombosis as a cause of cauda equina syndrome and to consider endovenous treatment in a specialized center.

Exploiting the Transformation Temperature to Reform an Infolded Nitinol Self-Expanding Peripheral Stent.

PURPOSE: Nickel-titanium (nitinol) alloys possess a special set of properties that allow for a wide range of applications. Specifically, the transformation temperature for self-expanding nitinol peripheral stents allows for easy crimping at or below room temperature and reformation at body temperature becoming superelastic. CASE REPORT: We report the case of an elderly man with iliac stenting 1 month prior, who presented several weeks after recovering from coronavirus disease 2019 with recurrent anterior-wall ST-elevation myocardial infarction. This was complicated by deformation and infolding of the previously implanted nitinol self-expanding stent in his right common iliac artery (CIA). Understanding nitinol's specific properties, we proceeded with rapid injections of iced saline to cool the nitinol stent to its transformation temperature while nudging the distal end of the stent with a partially inflated balloon. This maneuver softened the nitinol stent, allowing us to "unfold" and reappose it against the wall of the right CIA, resulting in successful restoration of the original shape of the nitinol self-expanding stent. CONCLUSION: This represents the first reported case describing treatment of an infolded nitinol self-expanding peripheral stent by exploiting the transformation temperature of nitinol using iced cold saline to successfully restore the stent's original shape and structure.

Intracranial stenting as a bail-out option for posthemorrhagic cerebral vasospasm: a single-center experience with long-term follow-up.

BACKGROUND: Cerebral vasospasm (CVS) is a leading cause of morbidity and mortality in patients after aneurysmal subarachnoid hemorrhage (aSAH). Endovascular treatment, including intraarterial infusion of drugs with vasodilation effects, and balloon- and stentriever angioplasty, are helpful but may achieve only short-term effects. There is a clinical need for long-lasting treatment of refractory recurrent vasospasm. We report our experience in stent implantation as a treatment for recurrent severe post-SAH vasospasm. METHODS: A retrospective analysis of our institutional database of 883 patients with SAH, managed between January 2010 and December 2021, was performed. Six patients were identified as having received intracranial stenting in the context of post-SAH cerebral vasospasm. All patients were initially treated with intra-arterial infusion of nimodipine and/or milrinone. Self-expanding intracranial stents were implanted during endovascular aneurysm treatment to enable access despite impaired perfusion (Group 1) or as a bail-out strategy after failed intraarterial drug infusion or mechanical treatment (Group 2). All stented patients received dual antiplatelet therapy (DAPT) for 6 months. RESULTS: Nine vessels in six patients with severe post-SAH vasospasm were stented. The stents were deployed in 16 vessel segments. All attempted implantations were technically successful. All patients demonstrated radiographic and clinical improvement of the vessel narrowing. No recurrent vasospasm or permanent vessel occlusion of the stented vessels was encountered. A thrombus formation in a Group 1 patient resolved under 4 mg eptifibatide IA infusion. During long-term angiographic follow-up, neither in-stent stenosis nor stent occlusion was found. CONCLUSIONS: Endovascular implantation of self-expanding stents is a potential ultima ratio strategy for patients with severe refractory post-SAH cerebral vasospasm. Stents with reduced thrombogenicity (avoiding DAPT) and bioabsorbable self-expanding stents might further advance this concept.

BioMimics 3D vascular stent system for femoropopliteal interventions.

Background: The MIMICS-3D study aimed to assess the safety and effectiveness of the BioMimics 3D Vascular Stent System for the treatment of symptomatic femoropopliteal artery disease in a real-world patient population. Patients and methods: Consecutive participants who were scheduled for implantation of the BioMimics 3D stent were enrolled in the prospective, observational, multicenter study. The primary effectiveness outcome was freedom from clinically driven target lesion revascularization at 12 months and the primary safety outcome was a composite of major adverse events comprising death, major target limb amputation, or clinically driven target lesion revascularization at 30 days. Outcomes through 24 months are reported. Results: A total of 507 patients (70±10 years, 65.5% male sex) were enrolled and treated with the study stent. 24.0% had critical limb-threatening ischemia, lesion length was 127±92 mm, and 56.8% of lesions were totally occluded. The Kaplan-Meier (KM) estimate of freedom from clinically driven target lesion revascularization at twelve-months was 90.6% (95% CI: 87.9%-93.3%) and the 30-day primary safety outcome occurred in 1.2% (95% CI: 0.5%-2.7%) of participants. At 24 months, clinical improvement was achieved in 86.6% and the KM estimate of freedom from clinically driven target lesion revascularization was 82.8% (95% CI: 79.4%-86.4%). The KM estimate of freedom from loss of primary patency according to PSVR >2.4 was 78.6% (95% CI: 74.7%-82.4%). Survival distribution functions regarding primary patency were lower with long lesions (>150 mm; log-rank p<0.001) but did not differ significantly between participants with or without critical limb-threatening ischemia (log-rank p=0.07). Conclusions: Endovascular treatment of atherosclerotic femoropopliteal lesions with the BioMimics 3D Vascular Stent System is efficacious and safe in a real-world setting.

Deformation and stenosis of the sinus-SuperFlex-DS stent after ductal stenting for the hybrid stage 1 procedure.

We present five cases of sinus-SuperFlex-DS stent stenosis during early follow up that resulted in inadequate ductal patency and required urgent re-stenting with a balloon-expandable stent. This causes concern that these stents lack sufficient radial force against ductal constriction and if used need to be kept under close scrutiny.

Impact of IVUS-Derived Vessel Size on Midterm Outcomes After Stent Implantation in Femoropopliteal Lesions.

Purpose: To identify intravascular ultrasound (IVUS) findings that predict midterm stent patency in femoropopliteal (FP) lesions. Materials and Methods: A retrospective analysis was undertaken of 335 de novo FP lesions in 274 consecutive patients (mean age 72.4±8.2 years; 210 men) who had IVUS assessment before and after successful stent implantation. The mean lesion length was 13.2±9.8 cm. The primary outcome was primary patency at 24 months, defined as freedom from major adverse limb event (MALE) and in-stent restenosis (ISR). MALE was defined as major amputation or any target lesion revascularization (TLR). ISR was defined by a peak systolic velocity ratio >2.4 by duplex ultrasonography. Logistic regression analyses were performed to identify independent predictors of stent patency at 24 months; the results are presented as the odds ratio (OR) and 95% confidence interval (CI). Receiver operator characteristic (ROC) curve analysis was performed to determine the optimal threshold for prediction of stent patency at 24 months. Results: Over the 24-month follow-up, 18 (7%) patients died and 43 (15%) of 286 lesions were responsible for MALE (42 TLRs and 1 major amputation). Primary patency was estimated at 82.5% (95% CI 78.1% to 86.9%) at 12 months and 73.2% (95% CI 67.9% to 78.5%) at 24 months. Multivariable analysis revealed that longer lesion length (OR 0.89, 95% CI 0.82 to 0.97, p<0.01) was an independent predictor of declining patency, while cilostazol use (OR 3.45, 95% CI 1.10 to 10.78, p=0.03) and increasing distal reference external elastic membrane (EEM) area (OR 1.18, 95% CI 1.02 to 1.37, p=0.03) were associated with midterm stent patency. ROC curve analysis identified a distal reference EEM area of 29.0 mm2 as the optimal cut-point for prediction of 24-month stent patency (area under the ROC curve 0.764). Kaplan-Meier estimates of 24-month primary patency were 83.7% (95% CI 78.3% to 89.2%) in lesions with a distal EEM area >29.0 mm2 vs 53.1% (95% CI 42.9% to 63.3%) in those with a distal EEM area ≤29.0 mm2 (p<0.001). Conclusion: In FP lesions with a larger distal vessel area estimated with IVUS, stent implantation can be considered as a reasonable treatment option, with the likelihood of acceptable midterm results.

Gutter Characteristics and Stent Compression of Self-Expanding vs Balloon-Expandable Chimney Grafts in Juxtarenal Aneurysm Models.

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

Chimney Endovascular Aneurysm Repair Using Endurant Stent-Grafts With Bare Balloon-Expandable Stents for Patients With Juxtarenal Aortic Aneurysms.

PURPOSE: To evaluate the advantages of chimney endovascular aneurysm repair (chEVAR) using an Endurant stent-graft with uncovered balloon-expandable stents (BES) for patients with juxtarenal aortic aneurysms. MATERIALS AND METHODS: Twenty-two patients (mean age 78.5±9.0 years; 13 men) who underwent chEVAR using Endurant and uncovered BES between January 2014 and December 2017 were analyzed retrospectively. The maximum aneurysm diameter was 59.1±11.9 mm, and the proximal neck length was 5.2±2.9 mm. Of the 22 cases, 9 (40%) involved proximal neck angulation and 9 (40%) had a conical neck. Single and double chimneys were performed using BES in 19 and 3 cases, respectively. In 2 cases, an additional self-expanding covered stent was used inside the uncovered BES. RESULTS: The technical success was 91% (20/22) as 2 (9%) cases showed minor type Ia endoleak. No postoperative systemic complications or acute renal dysfunction (Acute Kidney Injury Network classification stage 2 or higher) were observed. The mean radiologic observation period was 16.1±9.6 months, and no aneurysm expansion (>5 mm) was observed during this time. The mean maximum aneurysm diameter decreased to 52.9±10.2 mm (p<0.001 vs preoperative), with an individual mean sac regression of 6.2±5.9 mm. Overall primary chimney stent patency was 100%. One of the 2 cases of intraoperative type Ia endoleak resolved at the 6-month imaging, and no new type Ia endoleaks developed in any cases at follow-up. No additional treatment- or aneurysm-related events were observed. CONCLUSION: Short-term outcomes of chEVAR using Endurant with uncovered BES have been favorable when covered stents were unavailable, and it can be useful for high-risk patients with juxtarenal aortic aneurysms.

Self-Expanding Nitinol Stent vs Percutaneous Transluminal Angioplasty in the Treatment of Femoropopliteal Lesions: 3-Year Data From the SM-01 Trial.

PURPOSE: To report the midterm outcomes of a trial comparing self-expanding nitinol stents to percutaneous transluminal angioplasty (PTA) with provisional stenting in the treatment of obstructive disease in the superficial femoral and popliteal arteries. MATERIALS AND METHODS: The SM-01 study ( ClinicalTrials.gov identifier NCT01183117), a single-blinded, multicenter, randomized controlled trial in Japan, enrolled 105 consecutive patients with de novo or postangioplasty restenotic femoropopliteal lesions; after removing protocol violations (1 from each group), 51 patients (mean age 74±8 years; 36 men) in the stent group and 52 patients (mean age 73±8 years; 35 men) in the PTA group were included in the intention-to-treat analysis. The groups were well-matched at baseline. Patients were followed to 36 months with duplex imaging. Three-year primary patency was assessed based on a duplex-derived peak systolic velocity ratio <2.5. Freedom from clinically-driven target vessel revascularization (TVR) and target lesions revascularization (TLR) were estimated using the Kaplan-Meier method. RESULTS: The technical success rate was higher (100% vs 48%, p<0.001) and the frequency of vascular dissection was lower (4% vs 31%, p<0.001) in the stent group. The S.M.A.R.T stent group had a higher 3-year primary patency rate (73% vs 51%, p=0.033). Freedom from clinically-driven TVR and TLR were not significantly different between the groups. CONCLUSION: The S.M.A.R.T. stent maintained a higher primary patency rate than PTA at 3 years in this randomized trial; the need for clinically-driven revascularization was similar for both therapies.

Secondary Fill Minimizes Gutter Size in Chimney EVAS Configurations In Vitro.

PURPOSE: To investigate in an in vitro model if secondary endobag filling can reduce gutter size during chimney endovascular aneurysm sealing (chEVAS). MATERIALS AND METHODS: Nellix EVAS systems were deployed in 2 silicone juxtarenal aneurysm models with suprarenal aortic diameters of 19 and 24 mm. Four configurations were tested: EVAS with 6-mm balloon-expandable (BE) or self-expanding (SE) chimney grafts (CGs) in the renal branches of both models. Balloons were inflated simultaneously in the CGs and main endografts during primary and secondary endobag filling and polymer curing. Computed tomography (CT) was performed immediately after the primary and secondary fills. Cross-sectional lumen areas were measured on the CT images to calculate gutter volumes and percent change. CG compression was calculated as the reduction in lumen surface area measured perpendicular to the central lumen line. The largest gutter volume and highest compression were presented per CG configuration per model. RESULTS: Secondary endobag filling reduced the largest gutter volumes from 99.4 to 73.1 mm3 (13.2% change) and 84.2 to 72.0 mm3 (27.6% change) in the BECG configurations and from 67.2 to 44.0 mm3 (34.5% change) and 92.7 to 82.3 mm3 (11.2% change) in the SECG configurations in the 19- and 24-mm models, respectively. Secondary endobag filling increased CG compression in 6 of 8 configurations. BECG compression changed by -0.2% and 5.4% and by -1.0% and 0.4% in the 19- and 24-mm models, respectively. SECG compression changed by 10.2% and 16.0% and by 7.2% and 7.3% in the 19- and 24-mm models, respectively. CONCLUSION: Secondary endobag filling reduced paragraft gutters; however, this technique did not obliterate them. Increased CG compression and prolonged renal ischemia time should be considered if secondary endobag filling is used.

Effectiveness of the Pulsar-18 self-expanding stent with optional drug-coated balloon angioplasty in the treatment of femoropopliteal lesions - the BIOFLEX PEACE All-Comers Registry.

Background: Previous studies showed favorable results after treatment of femoropopliteal lesions with the Pulsar-18 self-expanding (SE) nitinol stent. The objective of this registry was to evaluate whether these results will be confirmed in a real-world setting with varying stenting strategies. Patients and methods: In this prospective, observational trial, 160 patients with 186 femoropopliteal lesions were treated with the Pulsar-18 SE nitinol stent at 9 German sites. Mean lesion length was 116 ± 103 mm, and 41.9 % of the lesions were moderately or heavily calcified. Eighty lesions were concomitantly treated with drug-coated balloon (DCB). Main effectiveness outcome was primary patency at 12 months, and main safety outcome was freedom from the composite of device or procedure related death, major target limb amputation, and clinically driven target lesion revascularization (TLR) at 30 days and 6 months. Results: Kaplan-Meier estimate of primary patency was 89.1 %, 67.3 %, and 57.1 % at 6, 12, and 24 months. Freedom from TLR was 95.5 %, 91.4 %, and 85.2 % at 6, 12, and 24 months, respectively. Lesions, which were additionally treated with DCB (plus DCB-group), were longer (150 versus 82 mm on average, p < 0.0001), and associated with lower primary patency estimates than those without DCB angioplasty (stent-only-group) (log-rank p = 0.006). However, there was no difference in freedom from TLR between groups (log-rank p = 0.542). Improvement by ≥ 1 Rutherford category was achieved in 84.8 %, 81.0 %, and 81.7 % of patients at 6, 12, and 24 months, respectively. Walking distance and patient-reported pain improved persistently through 24 months (p < 0.001). Hemodynamic improvement was achieved in 68.2 %, 73.7 %, and 70.7 % of the patients at 6, 12, and 24 months, respectively. Conclusions: The Pulsar-18 self-expanding nitinol stent with optional drug-coated balloon angioplasty can be considered an efficacious and safe therapy option for endovascular treatment of femoropopliteal artery disease.

In Vitro Quantification of Gutter Formation and Chimney Graft Compression in Chimney EVAR Stent-Graft Configurations Using Electrocardiography-Gated Computed Tomography.

PURPOSE: To assess the dynamic behavior of chimney grafts during the cardiac cycle. METHODS: Three chimney endovascular aneurysm repair (EVAR) stent-graft configurations (Endurant and Advanta V12, Endurant and Viabahn, and Endurant and BeGraft) were placed in silicone aneurysm models and subjected to physiologic flow. Electrocardiography (ECG)-gated contrast-enhanced computed tomography was used to visualize geometric changes during the cardiac cycle. Endograft and chimney graft surface, gutter volume, chimney graft angulation over the center lumen line, and the D-ratio (the ratio between the lengths of the major and minor axes) were independently assessed by 2 observers at 10 time points in the cardiac cycle. RESULTS: Both gutter volumes and chimney graft geometry changed significantly during the cardiac cycle in all 3 configurations (p<0.001). Gutters and endoleaks were observed in all configurations. The largest gutter volume (232.8 mm3) and change in volume (20.7 mm3) between systole and diastole were observed in the Endurant-Advanta configuration. These values were 2.7- and 3.0-fold higher, respectively, compared to the Endurant-Viabahn configuration and 1.7- and 1.6-fold higher as observed in the Endurant-BeGraft configuration. The Endurant-Viabahn configuration had the highest D-ratio (right, 1.26-1.35; left, 1.33-1.48), while the Endurant-BeGraft configuration had the lowest (right, 1.11-1.17; left, 1.08-1.15). Assessment of the interobserver variability showed a high correlation (intraclass correlation >0.935) between measurements. CONCLUSION: Gutter volumes and stent compression are dynamic phenomena that reshape during the cardiac cycle. Compelling differences were observed during the cardiac cycle in all configurations, with the self-expanding (Endurant-Viabahn) chimney EVAR configurations having smaller gutters and less variation in gutter volume during the cardiac cycle yet more stent compression without affecting the chimney graft surface.

One-Year Outcomes of the Paclitaxel-Eluting, Self-Expanding Stentys Stent System in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia.

PURPOSE: To investigate the efficacy of the paclitaxel-coated, self-expanding, nitinol Stentys Stent System in tibioperoneal lesions ≤50 mm long. METHODS: The prospective, single-arm, multicenter PES-BTK-70 trial ( ClinicalTrials.gov identifier NCT01630070) evaluated the safety and efficacy of the coronary Stentys Stent System in the treatment of a stenotic or occlusive lesion ≤50 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). Between January 2012 and May 2013, 70 patients (mean age 74.6±9.4 years; 45 men) with CLI [Rutherford category 4 (37, 52.9%) or 5 (33, 47.1%)] received a Stentys drug-eluting stent for the treatment of infrapopliteal stenosis (60, 85.7%) or occlusion (10, 14.3%). The mean lesion length was 17.2 mm (4.0-58.5). The primary outcome measures were primary patency at 6 months (duplex ultrasound) and 12 months (angiography). Secondary outcomes included limb salvage and freedom from target lesion revascularization (TLR). Kaplan-Meier estimates of the outcomes are given with the 95% confidence intervals (CI). RESULTS: Technical and procedure success (<30% residual stenosis without major complications) was achieved in 68 (97.1%) of 70 cases. Primary patency was 87.6% (95% CI 83.5% to 91.7%) at 6 months and 72.6% (95% CI 66.9% to 78.3%) at 1 year. Freedom from TLR was 79.1% at 1 year (95% CI 73.9% to 84.3) and limb salvage was 98.5% (95% CI 97.0 to 100.0). No stent fractures were found by core laboratory review of all follow-up imaging data available up to 12 months. CONCLUSION: In this study, the self-expanding, nitinol, paclitaxel-eluting, coronary Stentys stent was found to be safe and effective in the below-the-knee region, with results similar to the most recent limus-eluting stent trials.

Short-term Results of the RAPID Randomized Trial of the Legflow Paclitaxel-Eluting Balloon With Supera Stenting vs Supera Stenting Alone for the Treatment of Intermediate and Long Superficial Femoral Artery Lesions.

PURPOSE: To report a randomized trial comparing the Legflow paclitaxel-eluting balloon (PEB) + Supera stenting to Supera stenting alone in patients with intermediate to long superficial femoral artery (SFA) lesions. METHODS: The multicenter RAPID trial ( controlled-trials.com ; identifier ISRCTN47846578) randomized (1:1) 160 patients (mean age 67 years; 102 men) with Rutherford category 2-6 ischemia to treatment with Legflow PEB + Supera stent or Supera stent alone in intermediate to long SFA lesions (mean lesion length 15.8±7.4 vs 15.8±7.6 cm, respectively). The efficacy outcome was primary patency, defined as freedom from restenosis on duplex ultrasound or angiography. RESULTS: Baseline characteristics including the percentage of occlusions were similar between groups. In the intention-to-treat analysis, the estimated primary patency at 1 year was 68.3% (95% CI 56.7% to 79.9%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the Supera group (p=0.900). Per-protocol analysis showed a 12-month primary patency estimate of 74.7% (95% CI 63.1% to 86.3%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the control group (p=0.273). Secondary patency estimates at 12 months (per-protocol analysis) were 89.0% (95% CI 80.6% to 97.4%) vs 98.0% (95% CI 94.1% to 100%; p=0.484); the estimates for freedom from clinically driven target lesion revascularization (CD-TLR) were 83.0% (95% CI 72.8% to 93.2%) and 77.8% (95% CI 66.6% to 89.0%; p=0.277), respectively. CONCLUSION: The short-term results from the multicenter RAPID randomized controlled trial indicate that the Legflow PEB is safe and feasible for the treatment of intermediate to long SFA lesions. In this trial, at least 70% of the patients suffered an occlusion. The PEB group had higher rates of primary patency and freedom from CD-TLR, although there were no statistically significant differences vs controls.

Novel Approaches to Reducing the Risk of Variceal Hemorrhage.

BACKGROUND: Complications of advanced liver disease occur at the moment of clinical significant portal hypertension. Nitric oxide (NO) dysfunction and fibrosis play an important role in the pathophysiology of PH, but other mechanisms are also involved. Non-selective beta blockers (NSBB) stay the cornerstone in the primary and secondary prevention of variceal bleeding, but their safety in advanced cirrhosis has been recently debated and new drugs are under investigation. Transjugular intrahepatic portosystemic shunt and balloon tamponade are the standard therapy in case of refractory variceal bleeding, but both interventions have drawbacks. Key Message: Transelastography under certain conditions and the presence of collateral circulation on imaging allow to rule-in CSPH, which makes patients open at risk for variceal hemorrhage. FXR agonists are intrahepatic NO donors; they reduce fibrosis and prevent bacterial translocation, which make them promising drugs for the treatment of PH. NSBB should be used with caution in patients with refractory ascites and certainly in those with hepatorenal syndrome. Preliminary clinical data suggest that simvastatin and enoxaparin improve the prognosis of patients with cirrhosis. Finally, covered esophageal metallic stents are safer and more effective than balloon tamponade in the case of refactory variceal bleeding. CONCLUSIONS: Liver stiffness measurements enable the selection of patients for endoscopic screening for esophageal varices. In the case of tense ascites, the dose of NSBB should be adapted to the hemodynamic condition of the patient. Self-expanding, covered esophageal metallic stents replace balloon tamponade in the treatment of massive variceal hemorrhage.