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Hypoechoic peri-stent areas in duplex ultrasonography (DUS) (ie, "halo") have been noted following femoropopliteal artery stenting. This study sought to investigate the prevalence, risk factors, and potential safety implications of hypoechoic halos identified with DUS following stent implantation in the IMPERIAL (ELUVIA Drug-Eluting Stent Versus Zilver PTX Stent) and EMINENT (Trial Comparing ELUVIA Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery) trials. The IMPERIAL and EMINENT studies of femoropopliteal artery stenting included polymer-based drug-eluting stent, nonpolymer drug-coated stent, and bare metal stent treatment arms. A dedicated DUS protocol was implemented for core laboratory assessment of halo presence at study follow-up visits. Logistic regressions were used to investigate risk factors for a halo sign and its impact on clinically driven target lesion revascularization and primary patency. Diagnostic DUS imaging from 659 patients was obtained at time points ranging from 6 months to 5 years post–stent implantation. Halo prevalence ranged from 20% to 35% of patients with diagnostic DUS and was present at all time intervals. Halos were identified surrounding all stent types. In analyses of patients with diagnostic imaging from at least 2 visits, halo presence typically persisted, with occasional cases of regression and development at later times. No statistically significant association was found for halo status (ie, halo vs no halo) on 1-year clinically driven target lesion revascularization (OR: 1.27; 95% CI: 0.70-2.30; P = 0.4240) or primary patency (OR: 0.68; 95% CI: 0.43-1.07; P = 0.0927). A hypoechoic halo following a femoropopliteal stent procedure is a common occurrence associated with all studied stent types. The presence of a halo appears to be benign with no associated clinical sequelae or effect on target vessel revascularization rates within 1 year of stent implantation. [Display omitted] [ABSTRACT FROM AUTHOR]

There has been growing use of intravascular ultrasound (IVUS) during lower extremity arterial and venous revascularization. Observational data suggest that the use of IVUS can improve periprocedural and long-term outcomes, but largescale prospective data remain limited. Consensus opinion regarding the appropriate use of IVUS during peripheral intervention is needed. The purpose of this consensus document is to provide guidance on the appropriate use of IVUS in various phases of peripheral arterial and venous interventions. A 12-member writing committee was convened to derive consensus regarding the appropriate clinical scenarios for use of peripheral IVUS. The group iteratively created a 72-question survey representing 12 lower extremity arterial interventional scenarios. Separately, a 40-question survey representing 8 iliofemoral venous interventional scenarios was constructed. Clinical scenarios were categorized by interventional phases: preintervention, intraprocedure, and postintervention optimization. Thirty international vascular experts (15 for each survey) anonymously completed the survey instrument. Results were categorized by appropriateness using the median value and disseminated to the voting panel to reevaluate for any disagreement. Consensus opinion concluded that IVUS use may be appropriate during the preintervention phase for evaluating the etiology of vessel occlusion and plaque morphology in the iliac and femoropopliteal arteries. IVUS was otherwise rated as appropriate during iliac and femoropopliteal revascularization in most other preintervention scenarios, as well as intraprocedural and postprocedural optimization phases. IVUS was rated appropriate in all interventional phases for the tibial arteries. For iliofemoral venous interventions, IVUS was rated as appropriate in all interventional phases. Expert consensus can help define clinical procedural scenarios in which peripheral IVUS may have value during lower extremity arterial and venous intervention while additional prospective data are collected. [Display omitted] [ABSTRACT FROM AUTHOR]

To determine 6-month interim safety, effectiveness, and multimodal imageability of imageable glass microsphere yttrium-90 (90Y) radioembolization for unresectable hepatocellular carcinoma (HCC) in a first-in-human trial. Imageable microspheres (Eye90 Microspheres; ABK Biomedical, Halifax, Nova Scotia, Canada), a U.S. Food and Drug Administration (FDA) Breakthrough-Designated Device consisting of glass radiopaque 90Y microspheres visible on computed tomography (CT) and single photon emission CT (SPECT), were used to treat 6 subjects with unresectable HCC. Patients underwent selective (≤2 segments) treatment in a prospective open-label pilot trial. Key inclusion criteria included liver-only HCC, performance status ≤1, total lesion diameter ≤9 cm, and Child-Pugh A status. Prospective partition dosimetry was utilized. Safety (measured by Common Terminology Criteria for Adverse Events [CTCAE] v5), multimodal imageability on CT and SPECT, and 3- and 6-month imaging response by modified Response Evaluation Criteria in Solid Tumors on magnetic resonance (MR) imaging were evaluated. Seven tumors in 6 subjects were treated and followed to 180 days. Administration success was 100%. Microsphere distribution measured by radiopacity on CT correlated with SPECT. Ninety-day target lesion complete response (CR) was observed in 3 of 6 subjects (50%) and partial response (PR) in 2 (33.3%). At 180 days, target lesion CR was maintained in 3 subjects (50%) and PR in 1 (16.7%). Two subjects could not be reassessed, having undergone intervening chemoembolization. All subjects reported adverse events (AEs), and 5 reported AEs related to treatment. There were no treatment-related Grade ≥3 AEs. Radioembolization using imageable microspheres was safe and effective in 6 subjects with unresectable HCC at 6-month interim analysis. Microsphere distribution by radiopacity on CT correlated with radioactivity distribution by SPECT, providing previously unavailable CT-based tumor targeting information. [Display omitted] [ABSTRACT FROM AUTHOR]

Purpose: To investigate the safety and efficacy of an aqueous polyethylene glycol-based liquid embolic agent, Embrace Hydrogel Embolic System (HES), in the treatment of benign and malignant hypervascular tumors.Materials and Methods: A prospective, single-arm, multicenter study included 8 patients, 5 males and 3 females, with a median age of 58.5 years (30-85 years), who underwent embolization in 8 tumors between October 2019 and May 2020. Technical success was defined as successful delivery of HES to the index vessel, with disappearance of >90% of the targeted vascular enhancement or, for portal vein embolization, occlusion of the portal branches to the liver segments for future resection. The volume of HES administered, ease of use (5 point Likert scale), administration time, and adverse events (AEs) were recorded. Evaluation was performed at 7, 30, and 90 days via clinical assessment and blood testing, and follow-up imaging was performed at 30 days.Results: Eight patients were enrolled, and 10 embolizations were performed in 8 lesions. Tumors included hepatocellular carcinoma (n = 4), renal angiomyolipoma (n = 3), and intrahepatic cholangiocarcinoma (n = 1). Technical success was 100%, and the average ease of use was 3.3 ± 1.0 SD. The HES delivery time was 1-28 minutes (median, 16.5 minutes), and the HES volume injected was 0.4-4.0 mL (median, 1.3 mL). All patients reached 30-day follow-up with imaging, and 6 patients reached 90-day follow-up. There were 3 serious AEs in 2 patients that were unrelated to the embolic agent.Conclusion: HES resulted in a 100% embolization technical success rate. The product ease of use was acceptable, and no target vessel recanalization was noted on follow-up imaging at 30 days. [ABSTRACT FROM AUTHOR]

To perform a meta-analysis of two concordant randomized controlled trials (RCTs) examining the long-term, 4-year safety profile of the Stellarex drug-coated balloon (DCB) vs percutaneous transluminal angioplasty (PTA) for the treatment of peripheral artery disease. An independent, third-party, meta-analysis of homogeneous, patient-level data from the ILLUMENATE Pivotal and ILLUMENATE EU RCTs was performed to assess mortality (time to death) in patients treated for symptomatic femoropopliteal disease. The Kaplan-Meier (KM) methodology was used to estimate hazard rates [HRs] of all-cause mortality, and Cox proportional hazard modeling was used to assess predictors of mortality. All serious adverse events, including deaths, were adjudicated by an independent, blinded clinical events committee. In total, 589 (419 DCB; 170 PTA) patients were included in the pooled analysis of the ILLUMENATE Pivotal and ILLUMENATE EU RCTs. The median follow-up was 1735 days (interquartile range, 1434-1829 days), equivalent to 4.75 years. Vital status compliance was >95% in each RCT. The total number of deaths through 4 years was 81 of 589 (13.8%): 58 of 419 (13.8%) in the DCB arm and 23 of 170 (13.5%) in the PTA arm. The 1-year KM estimate of all-cause mortality was 1.9% ± 0.7% (estimate ±standard error) in those treated with DCB vs 1.2% ± 0.9% in those treated with PTA. At 2, 3, and 4 years, the respective KM estimates were 6.6% ± 1.2% vs 4.9% ± 1.7%, 9.3% ± 1.4% vs 9.9% ± 2.4%, and 14.0% ± 1.7% vs 14.4% ± 2.8% (P =.864). There were no significant differences in clinical events committee-adjudicated deaths between the two cohorts. In multivariate analysis, predictors of 4-year mortality were age (HR, 1.048; 95% confidence interval [CI], 1.026-1.071; P <.0001), renal insufficiency (HR, 2.440; 95% CI, 1.566-3.800; P <.0001), and lesion length (HR, 1.004; 95% CI, 1.000-1.008; P =.041). Neither paclitaxel exposure (DCB vs PTA; HR, 1.086; 95% CI, 0.709-1.664; P =.705) nor dose (mg; HR, 1.043; 95% CI, 0.971-1.119; P =.248) was the predictor of all-cause mortality at 4 years. This systematic meta-analysis of two concordant ILLUMENATE RCTs shows no difference in all-cause mortality through 4 years between Stellarex DCB and PTA, confirming the acceptable, long-term safety profile of the Stellarex DCB. [ABSTRACT FROM AUTHOR]

The aim of this study was to seek expert consensus regarding the features that predict adverse outcomes in order to develop a dedicated angiographic classification system for femoropopliteal artery dissection. Dissection of the femoral and popliteal arteries is common after percutaneous angioplasty. Its classification is important. However, all current classification systems have significant limitations. Delphi consensus methodology was performed over 3 rounds, using an expert panel of 17 interventionalists. Each was asked to rank dissection features with the potential to lead to acute technical failure and/or early restenosis and then which combination of features would require the placement of a metallic scaffold to avoid those outcomes. Results were used to develop a novel grading system and dissection treatment algorithm. Four main characteristics were identified from a comprehensive preliminary list. There was a good level of agreement between panelists from 773 responses (48 combinations). All panelists recommended scaffolding if a dissection produced a ≥50% diameter reduction (100%). Most recommended scaffolding if the dissection had a spiral shape (73%-100%), was severely flow limiting (93%-100%), or had complex morphology defined by long and multiple dissections (65%-100%). Multiple combinations of those features were more likely to receive a recommendation to scaffold. Scaffolding of a postangioplasty dissection is recommended in the presence of significant diameter reduction, spiral shape, flow impairment, or adverse morphology (DISFORM). The DISFORM classification system has been developed as a tool to provide uniform language to standardize reporting and for discussion of dissection treatment and prognosis. [Display omitted] [ABSTRACT FROM AUTHOR]

To determine the safety and efficacy of treating abdominal aortic aneurysm (AAA) sacs with polyurethane shape memory polymer (SMP) devices during endovascular aneurysm repair (EVAR), using a technique to fully treat the target lumen after endograft placement (aortic flow volume minus the endograft volume). SMP devices self-expand in the sac to form a porous scaffold that supports thrombosis throughout its structure. Two identical prospective, multicenter, single-arm studies were conducted in New Zealand and the Netherlands. The study population was adult candidates for elective EVAR of an infrarenal AAA (diameter of ≥55 mm in men and ≥50 mm in women). Key exclusion criteria were an inability to adequately seal a common iliac artery aneurysm, patent sac feeding vessels of >4 mm, and a target lumen volume of <20 mL or >135 mL. Target lumen volumes were estimated by subtracting endograft volumes from preprocedural imaging-based flow lumen volumes. SMP devices were delivered immediately after endograft deployment via a 6F sheath jailed in a bowed position in the sac. The primary efficacy end point was technical success, defined as filling the actual target lumen volume with fully expanded SMP at the completion of the procedure. Secondary efficacy outcome measures during follow-up were the change in sac volume and diameter, rate of type II endoleak and type I or III endoleaks, and the rate of open repair and related reinterventions, with data collection at 30 days, 6 months, and 1 year (to date). Baseline sac volumes and diameters for change in sac size analyses were determined from 30-day imaging studies. Baseline and follow-up volumes were normalized by subtraction of the endograft volume. Of 34 patients treated with SMP devices and followed per protocol, 33 patients were evaluable at 1 year. Preprocedural aneurysm volume was 181.4 mL (95% confidence interval [CI], 150.7-212.1 mL) and preprocedural aneurysm diameter was 60.8 mm (95% CI, 57.8-63.9 mm). The target lumen volume was 56.3 mL (95% CI, 46.9-65.8 mL). Technical success was 100% and the ratio of SMP fully expanded volume to estimated target lumen volume was 1.4 ± 0.3. Baseline normalized sac volume and diameter were 140.7 mL (95% CI, 126.6-154.9 mL) and 61.0 mm (95% CI, 59.7-62.3 mm). The adjusted mean percentage change in normalized volume at 1 year was −28.8% (95% CI, −35.3 to −22.3%; P <.001). The adjusted mean change in sac diameter at 1 year was −5.9 mm (95% CI, −7.5 to −4.4 mm; P <.001). At 1 year, 81.8% of patients (95% CI, 64.5%-93.0%) achieved a ≥10% decrease in normalized volume and 57.6% of patients (95% CI, 39.2%-74.5%) achieved a ≥5 mm decrease in diameter. No device- or study procedure-related major adverse events occurred through 1 year after the procedure. Treatment of AAA sacs with SMP devices during EVAR resulted in significant sac volume and diameter regression at 1 year with an acceptable safety profile in this prospective study. [ABSTRACT FROM AUTHOR]

The study sought to compare short-term outcomes in patients with femoropopliteal artery calcification receiving vessel preparation with intravascular lithotripsy (IVL) or percutaneous transluminal angioplasty (PTA) prior to drug-coated balloon (DCB) for symptomatic peripheral artery disease. Endovascular treatment of calcified peripheral artery lesions is associated with suboptimal vessel expansion and increased complication risk. Although initial results from single-arm studies with IVL have been reported, comparative evidence from randomized trials is lacking for most devices in the presence of heavy calcification. The Disrupt PAD III (Shockwave Medical Peripheral Lithoplasty System Study for PAD) randomized trial enrolled patients with moderate or severe calcification in a femoropopliteal artery who underwent vessel preparation with IVL or PTA prior to DCB or stenting. The primary endpoint was core lab–adjudicated procedural success (residual stenosis ≤30% without flow-limiting dissection) prior to DCB or stenting. In patients receiving IVL (n = 153) or PTA (n = 153), procedural success was greater in the IVL group (65.8% vs. 50.4%; p = 0.01) and the percentage of lesions with residual stenosis ≤30% (66.4% vs. 51.9%; p = 0.02) was greater in the IVL group, while flow-limiting dissections occurred more frequently in the PTA group (1.4% vs. 6.8%; p = 0.03). Post-dilatation (5.2% vs. 17.0%; p = 0.001) and stent placement (4.6% vs. 18.3%; p < 0.001) were also greater in the PTA group. The rates of major adverse events (IVL: 0% vs. PTA: 1.3%; p = 0.16) and clinically driven target lesion revascularization (IVL: 0.7% vs. PTA: 0.7%; p = 1.0) at 30 days were comparable between groups. IVL is an effective vessel preparation strategy that facilitates definitive endovascular treatment in calcified femoropopliteal arteries in patients with peripheral artery disease. (Shockwave Medical Peripheral Lithoplasty System Study for PAD [Disrupt PAD III]; NCT02923193) [Display omitted] [ABSTRACT FROM AUTHOR]

A significant proportion of lesions treated with transcatheter interventions in the coronary and peripheral vascular beds exhibit moderate to severe calcific plaques known to portend lower procedural success rates, increased peri-procedural adverse events, and unfavorable clinical outcomes compared with noncalcific plaques. Adapted from lithotripsy technology used for treatment of ureterorenal calculi, intravascular lithotripsy (IVL) is a novel technique for the treatment of severely calcific plaque lesions that uses acoustic shockwaves in a balloon-based delivery system. Shockwaves induce calcium fractures, which facilitate stent expansion and luminal gain. In this review, the authors summarize the physics, preclinical and clinical data on IVL use in the coronary and peripheral vasculature, and future directions of IVL in transcatheter cardiovascular therapies. [Display omitted] • IVL has emerged as a novel therapy for treatment of vascular calcification. • IVL safely and effectively modifies calcified lesions via lithotripsy-driven fracture. • Understand longer-term outcomes following IVL modification of vascular calcification. [ABSTRACT FROM AUTHOR]

Peripheral vascular devices (stents and balloons) coated with paclitaxel were developed to address suboptimal outcomes associated with percutaneous revascularization procedures of the femoral-popliteal arteries. In randomized controlled trials (RCT), paclitaxel-coated devices (PCD) provided increased long-term patency and a decreased need for repeat revascularization procedures compared with uncoated devices. This finding resulted in the adoption of their use for endovascular lower extremity revascularization procedures. However, in late 2018 a study-level meta-analysis showed increased all-cause mortality at 2 years or more after the procedure in patients treated with PCDs. This review examines the subsequent data evaluation following the publication of the meta-analysis. We review the published responses of physicians, regulatory agencies, and patient advocates during 15-month period after the meta-analysis. We present the additional data gathered from RCTs that comprised the meta-analysis and safety outcomes from large insurance databases in both the United States and Europe. Immediately after the publication of the meta-analysis, concern for patient safety resulted in less PCD use, the suspension of large RCTs evaluating their use, and the publication of a letter from the U.S. Food and Drug Administration informing physicians that there was uncertainty in the benefit-risk profile of these devices for indicated patients and that the potential risk should be assessed before the use of PCDs. Review of the meta-analysis found that a mortality signal was present, but criticisms included that the evaluation was performed on study-level, not patient-level data, and the studies in the analysis were heterogenous in device type, paclitaxel doses, and patient characteristics. Further, the studies were not designed to be pooled nor were they powered for evaluating long-term safety. Clinical characteristics associated with a drug effect or causal relationship were also absent. Specifically, there was no dose response, no clustering of causes of death, and a lack of signal consistency across geographic regions. As more long-term data became available in the RCTs the strength of the mortality signal diminished and analysis of real-world use in large insurance databases, showed that there was no significant increase in all-cause mortality associated with PCD use. The available data do not provide definitive proof for increased mortality with PCD use. A key observation is that trial design improvements will be necessary to better evaluate the risk-benefit profile of PCDs. [ABSTRACT FROM AUTHOR]

A prospective, single-arm, open-label, multicenter, first-in-human, early feasibility study was completed to evaluate the safety and performance of the GPX Embolic Device (Fluidx, Salt Lake City, Utah), a novel liquid embolic agent, for use in the peripheral vasculature when deep distal embolization is desired. The early feasibility study evaluated the use of the device in the peripheral vasculature. Enrollment consisted of 17 patients with diverse embolization needs requiring deep distal vessel/vessel bed occlusion. Technical success, freedom from adverse events (AEs), and handling/performance characteristics were assessed with follow-up at 30 days. The trial enrolled 17 patients requiring distal vascular penetration of the embolic agent, including 7 with renal angiomyolipomas, 4 with renal cell carcinomas (primary and secondary), 4 with portal veins needing embolization, 1 with pelvic sarcoma, and 1 with polycystic kidney. In all cases (100%), technical success was achieved with target regions fully occluded on the first angiogram (taken immediately after delivery). Furthermore, the material received high usability ratings, as measured by a postprocedural investigator questionnaire. Most patients (15/17, 88.2%) were free from device-related severe AEs, and there were no unanticipated AEs during the study. Each patient completed a 30-day follow-up evaluation, and sites remained fully occluded in each case where imaging was available (6 [35.3%] of 17 patients had follow-up imaging where all sites were deemed occluded [100%] with a mean of 30.2 days after the procedure). The results of this first-in-human, early feasibility study demonstrate that the GPX Embolic Device may provide safe and effective embolization for arterial or venous applications where deep distal penetration is desired. [Display omitted] [ABSTRACT FROM AUTHOR]

The 1-year results of the use of the Nellix (Endologix Inc, Irvine, Calif) endovascular aneurysm sealing (EVAS) device were initially promising. However, midterm complications including migration and aneurysm growth occurred more frequently than expected, which provided an incentive to refine the instructions for use. Strategies for the management of complications arising after endovascular aneurysm repair are often not applicable for EVAS, given the unique configuration of the Nellix device, and new techniques are needed. This study analyzes the clinical outcomes of both elective and emergency deployment of a new Nellix device within a primarily placed device, for failure of EVAS, which we refer to as a Nellix-in-Nellix application (NINA). This is a global, retrospective, observational cohort study focusing on the early outcome of NINA for failed EVAS, including data from 11 European institutions and 1 hospital in New Zealand. A total of 41 patients were identified who underwent a NINA procedure. Of these, 32 (78%) were placed electively and 9 (22%) were placed on an emergency basis. Seven patients were initially treated with chimney EVAS (n = 5 in the elective NINA group and n = 2 in the emergency NINA group). The average time between the primary EVAS procedure and NINA was 573 days (interquartile range, [IQR] 397-1078 days) and 478 days (IQR, 120-806) for the elective and emergency groups, respectively. The indication for elective NINA was endoleak with migration (50%), endoleak without migration (25%), migration without endoleak (16%), and other (9%). Chimney grafts were used in 21 of 32 patients in the elective group and 3 of 9 patients in the emergency group. Technical success was achieved in 94% of patients in the elective group and 100% of patients in the emergency group. At latest follow-up (median, 104 days; IQR, 49-328 days), there were three aneurysm-related deaths (9%), no ruptures, and five device-related reinterventions (16%) within the elective group. In the emergency group (median follow-up, 23 days; IQR, 7-61 days), there were four aneurysm-related deaths and three aneurysm-related reinterventions. In conclusion, a NINA can be used to treat late failures of EVAS with an acceptable technical success rate and can be used when more established treatment options are unfeasible or contraindicated. The durability of this technique needs to be further reviewed. [ABSTRACT FROM AUTHOR]

The frozen elephant technique has simplified aortic arch surgery. As with thoracic endovascular aortic repair, frozen elephant technique reconstructions often require reintervention. Skilled endovascular management of frozen elephant technique complications is imperative as novel devices emerge. We describe 2 patients who required early intervention for severe foreshortening and incomplete expansion of the Thoraflex (Vascutek, Inchinnan, United Kingdom) stent graft. [ABSTRACT FROM AUTHOR]

To present the 36-month outcomes of the prospective randomized IN.PACT AV Access study of participants with obstructive de novo or restenotic native upper extremity arteriovenous dialysis fistula lesions treated with drug-coated balloon (DCBs) or standard percutaneous transluminal angioplasty (PTA) following successful high-pressure PTA. Participants at 29 international sites were randomized 1:1 to receive an IN.PACT AV DCB (n = 170) or undergo PTA (n = 160). The outcomes through 36 months included target lesion primary patency (TLPP) and access circuit primary patency (ACPP) (composites of clinically driven target lesion or access circuit revascularization and/or access circuit thrombosis), number of reinterventions, and serious adverse events involving the access circuit. TLPP was 52.1% in the DCB group compared with 36.7% in the PTA group through 24 months and 43.1% in the DCB group compared with 28.6% in the PTA group through 36 months (both log-rank P <.001). ACPP was 39.4% in the DCB group compared with 25.3% in the PTA group through 24 months and 26.4% in the DCB group compared with 16.6% in the PTA group through 36 months (both log-rank P <.001). Cumulative incidence of access circuit thrombosis through 36 months was 8.2% in the DCB group compared with 18.3% in the PTA group (log-rank P =.040). Cumulative incidence of mortality through 36 months was 26.6% in the DCB group compared with 30.8% in the PTA group (log-rank P =.71). This study demonstrated superior TLPP and ACPP with DCBs compared with PTA, with no difference in mortality through 3 years. Access circuit thrombosis was statistically significantly higher in the PTA group at 3 years. [Display omitted] [Display omitted] [ABSTRACT FROM AUTHOR]

Purpose: A prospective, single-center, single-arm feasibility study evaluated procedural and short-term performance of the Advance Enforcer 35 focal-force percutaneous transluminal angioplasty (PTA) balloon catheter in treating stenoses of mature native arteriovenous (AV) hemodialysis access circuits.Materials and Methods: Twenty-eight patients undergoing treatment for stenosis of a mature native AV hemodialysis access circuit were enrolled at a single institution. Angiographic assessments of the study lesion were required at baseline and after the procedure. Adjunctive procedures for significant residual stenosis were permitted, and patients had clinical and imaging follow-up for as long as 6 months.Results: Treatment with the study balloon was effective in reducing the average percent diameter stenosis of the treated lesion from 66.3% (range, 43.8%-93.3%) before the procedure to 23.7% (range, -6.7% to 51.4%) after the procedure. The average inflation pressure required was 12.3 atm. Only 1 patient required an adjunctive procedure, and all patients could resume normal dialysis following the study procedure. At 3 months, 62.0% of study lesions remained patent, and the 6-month patency rate was 25.1%. Two adverse events associated with the study procedure were reported: access-site hematoma and forearm pain (3.6% each).Conclusions: The results demonstrate safety of the study balloon in treating AV access stenosis. Nominal-diameter angioplasty was achieved at relatively low pressure in most study patients without the use of adjunctive procedures, and resumption of normal dialysis was achieved for all patients. [ABSTRACT FROM AUTHOR]

Endovascular aneurysm sealing (EVAS) is conceptually different than endovascular aneurysm repair (EVAR). Unlike EVAR which seals in healthy tissue at the proximal and distal attachment sites without direct treatment of the aneurysm sac, EVAS uses polymer to fill and actively treat the entire aneurysm. This "active sac management" addresses some of the limitations of the current EVAR devices including prevention of type II endoleak and low rates of sac expansion and rupture. The Nellix System is the only commercially available EVAS platform and has been available in Europe and New Zealand since 2013. Early outcomes with the Nellix System were encouraging and demonstrated high procedural and technical success with very low morbidity and mortality as well as low endoleak and secondary intervention rates. Two-year results have maintained a high freedom from overall endoleak and rupture, but 2-year imaging identified a low incidence of late complications-device migration, type 1A endoleak, and aneurysm sac expansion. In response, a field safety notification was issued by the manufacturer (Endologix, Inc, Irvine, CA) in October 2016. A dedicated root cause analysis resulted in refinements to the Instructions for Use. The EVAS procedure continues to evolve and improve. There have been alterations to procedural technique, device modification, and patient selection. Optimum management strategies for complications have also been developed. The focus of this article is to highlight the updates to the Nellix Instructions for Use for both patient selection and procedural techniques along with the associated clinical benefits as well as describe the management of migration, sac expansion, and type 1A endoleak. [ABSTRACT FROM AUTHOR]

To use safety and efficacy outcomes following treatment with percutaneous transluminal angioplasty (PTA) and/or stent placement for thoracic central venous obstruction in hemodialysis-dependent patients to establish objective performance goals (OPGs). A systematic literature review and meta-analysis were conducted for articles published between January 1, 2000, and August 31, 2021. Efficacy outcomes included primary patency rates at 6 and 12 months, and safety outcomes included adverse events (AEs) categorized as access loss, procedure-related AEs, and serious AEs (SAEs). OPGs were derived from the upper and lower bounds of the 95% confidence intervals for primary patency and SAE rates. Of 66 articles reviewed, 17 met the inclusion criteria (PTA, n = 4; stent placement, n = 5; PTA/stent, n = 8). The 6- and 12-month primary patency rates for PTA were 50.9% and 36.7%, respectively. Based on these findings, the proposed 6- and 12-month primary patency OPGs identifying superiority against PTA were 66.5% and 52.6%, respectively, and those for noninferiority were 39.0% and 25.7%, respectively. For stent placement, the 6- and 12-month primary patency rates were 69.7% and 47.9%, respectively. The proposed 6- and 12-month primary patency OPGs identifying superiority were 82.1% and 64.1%, respectively, and those for noninferiority were 59.3% and 35.8%, respectively. SAE rates for PTA and stent placement were 3.8% and 8.1%, respectively. Proposed safety OPGs for noninferiority versus superiority for PTA and stent placement were 10.1% versus 1.4% and 13.6% versus 4.8%, respectively. The OPGs derived from real-world studies of PTA and stent placement may serve as a benchmark for future interventions indicated for this patient population. [Display omitted] [ABSTRACT FROM AUTHOR]

There is no proven therapy to reduce growth rates of small- to medium-sized abdominal aortic aneurysms (AAAs). Ex vivo and animal studies have demonstrated that a novel stabilizing agent, 1,2,3,4,6-pentagalloyl glucose (PGG), delivered locally to the aneurysm sac, can bind to elastin and collagen to re-establish strength and resist enzymatic degradation. We aimed to demonstrate that a one-time administration of PGG solution to the aneurysm wall is safe and potentially effective to slow the growth of small- to medium-sized AAAs. Patients with small- to medium-sized infrarenal AAAs (maximum diameter <5.5 cm) were recruited. Via transfemoral access, a 14F or 16F dual-balloon delivery catheter was introduced into the aneurysm sac. A single, 3-minute, localized endoluminal infusion of PGG was delivered via a 'weeping' balloon to the aneurysm wall. Independent core laboratory measurements of maximum aneurysm sac diameter and sac volume measurements based on computed tomography angiography (CTA) were used for assessments at 1, 6, 12, 24, and 36 months. The primary endpoints were technical success and safety (major adverse events at 30 days). The secondary endpoint was growth stabilization, defined as freedom from aneurysm sac enlargement (diameter increase >5 mm per year or volume increase of >10% per year). Twenty patients (19 male) were enrolled at five centers from May 2019 to June 2022 (mean age, 67.8 years; range, 50-87 years). All procedures were technically successful. The safety profile was consistent with standard interventional procedures. Four patients demonstrated transient elevations of liver enzymes levels that returned to normal by 30 days with no clinical symptoms. Through November 2022, follow-up CTA data is available on the first 11 patients. The average changes in maximum aneurysm diameter from baseline to 6, 12, 24, and 36 months were 0.2 mm, 1.1 mm, 1.2 mm, and 0.8 mm, respectively, and the average changes in volume were 2.0%, 9.6%, 18.1%, and 11.6%, respectively. At 12 months, none of the aneurysms showed growth >5.0 mm, and three had volume growth >10%. The early results of this first-in-human, small cohort study demonstrated that a single, localized PGG administration to patients with small- to medium-sized infrarenal AAAs is safe. Longer term follow-up on all 20 treated patients is needed to better assess the potential impact on aneurysm growth. [ABSTRACT FROM AUTHOR]

Objective/Background Proximal type I endoleaks are associated with abdominal aortic aneurysm (AAA) growth and rupture and necessitate repair. The Nellix™ EndoVascular Aneurysm Sealing (EVAS) system is a unique approach to AAA repair, where the appearance and treatment of endoleaks is also different. This study aimed to analyse and categorise proximal endoleaks in an EVAS treated cohort. Methods All patients, treated from February 2013 to December 2015, in 15 experienced EVAS centres, presenting with proximal endoleak were included. Computed tomography scans were analysed by a core laboratory. A consensus meeting was organised to discuss and qualify each case for selection, technical aspects, and possible causes of the endoleak. Endoleaks were classified using a novel classification system for EVAS. Results During the study period 1851 patients were treated using EVAS at 15 centres and followed for a median of 494 ± 283 days. Among these, 58 cases (3.1%) developed a proximal endoleak (1.5% early and 1.7% late); of these, 84% of 58 patients were treated outside the original and 96% outside the current, refined, instructions for use. Low stent positioning was the most likely cause in 44.6%, a hostile anatomy in 16.1%, and a combination of both in 33.9%. Treatment, by embolisation or proximal extension, was performed in 47% of cases, with a technical success of 97%. Conclusion The overall incidence of proximal endoleak after EVAS is 3.1% after a mean follow-up period of 16 months, with 1.5% occurring within 30 days. Their occurrence is related to patient selection and stent positioning. Early detection and classification is crucial to avoid the potential of sac rupture. [ABSTRACT FROM AUTHOR]

Objective The purpose of this study was to determine the long-term effectiveness of endovascular aneurysm sealing (EVAS) in the treatment of complex aortoiliac aneurysms with preservation of hypogastric artery flow. Methods We reviewed all patients with abdominal aortic aneurysms (AAAs) and common iliac aneurysms (CIAs) enrolled and treated in prospective studies of EVAS using the Nellix endograft (Endologix, Irvine, Calif) at two centers from 2008 to 2014. Patients with 1 year or more of computed tomography follow-up underwent quantitative morphometric assessment by two independent vascular radiologists blinded to clinical outcome results. Hypogastric patency and CIA diameter changes over time were assessed and compared in three treatment groups: totally excluded CIA, partially excluded CIA, and untreated CIA. Results Among 125 patients with EVAS, 68 patients (mean age, 75 ± 8 years; 79% men) had both AAA (mean diameter, 55.8 ± 2.0 mm) and CIA (median diameter, 23.4; interquartile range, 21.3-27.0 mm), with bilateral CIAs in 33 patients. Treatment of 101 CIAs included complete CIA exclusion in 40 (39.6%), partial CIA exclusion in 33 (32.7%), and no CIA treatment in 28 (27.7%), with successful AAA exclusion in all patients. Internal iliac flow was preserved in all 122 hypogastric arteries that were patent before treatment (14 hypogastric arteries were occluded at baseline). During the 5-year follow-up period (median follow-up, 24.7 months; range, 11.5-61.7 months), three patients required secondary treatment with hypogastric occlusion and graft extension to the external iliac. Thus, internal iliac flow was maintained in 98% of at-risk hypogastric arteries. There were no aneurysm-related clinical events, except for the three secondary treatments. Totally excluded iliac aneurysms did not change in diameter over time ( P = .85), whereas untreated CIAs enlarged at a rate of 0.16 mm/y (95% confidence interval, 0.09-0.23; P < .0001). Partially excluded CIAs enlarged at a higher rate of 0.59 mm/y (95% confidence interval, 0.47-0.71; P < .0001). Enlargement ≥3 mm occurred only in partially treated CIAs larger than 3 cm. Conclusions EVAS was effective in treating aortoiliac aneurysms with preservation of internal iliac patency in most cases. Complete CIA exclusion prevented aneurysm enlargement over time, whereas partial exclusion did not prevent continued CIA enlargement, particularly in larger aneurysms. [ABSTRACT FROM AUTHOR]

Endovascular repair of abdominal aortic aneurysms (EVAR) is now an established treatment modality for suitable patients presenting with aneurysm rupture. EVAR for ruptured aneurysms reduces transfusion, mechanical ventilation, intensive care. and hospital stay when compared with open surgery. In the emergency setting, however, EVAR is limited by low applicability due to adverse clinical or anatomical characteristics and increased need for reintervention. In addition, ongoing bleeding from aortic side branches post-EVAR can cause hemodynamic instability, larger hematomas, and abdominal compartment syndrome. Endovascular aneurysm sealing, based on polymer filling of the aneurysm, has the potential to overcome some of the limitations of EVAR for ruptured aneurysms and to improve outcomes. Recent literature suggests that endovascular aneurysm sealing can be performed with early mortality similar to that of EVAR for ruptured aortic aneurysms, but experience is limited to a few centers and a small number of patients. The addition of chimney grafts can increase the applicability of endovascular aneurysm sealing in order to treat short-neck and juxtarenal aneurysms as an alternative to fenestrated endografts. Further evaluation of the technique, with larger longitudinal studies, is necessary before advocating wider implementation of endovascular aneurysm sealing in the emergency setting. [ABSTRACT FROM AUTHOR]

The published evidence on clinical outcomes of Nellix Endovascular Aneurysm Sealing for elective abdominal aortic aneurysm repair has confirmed low procedural morbidity and reintervention rate. This early clinical experience with Nellix is encouraging, despite the device and procedural steps being in evolution, and patients being treated outside of the recommended instructions for use. The long-term follow-up of a treated patient cohort is now available and demonstrates low aneurysm-related mortality and morbidity. The initial experience with the commercially available Nellix device was captured in a multicenter report involving 171 patients and two independently monitored, company-sponsored device registries (EVAS Forward Global Trial and Forward US Investigational Device Exemption Trial). All three clinical studies report a 99% procedural technical success, low mortality, and persistent endoleak rate with re-intervention rates comparable to conventional EVR device registries. Nellix EVAS is applicable to a range of aneurysm anatomies, including patients with isolated of concomitant iliac artery aneurysms. The post-procedural imaging appearances after Nellix EVAS are unique due to the AAA sac polymer, change with time, but are now well understood. [ABSTRACT FROM AUTHOR]

The successful transcatheter treatment of a type IA endoleak after endovascular aortic aneurysm sealing with the Nellix EndoVascular Aneurysm Sealing system (Endologix Inc, Irvine, California) using proximal covered stent extension and transarterial N-butyl cyanoacrylate sac embolization is described. Three patients were treated using the same technique with a mean interval between the index procedure and reintervention of 9.3 months (range, 3-15 mo). No complications or endoleaks were seen on follow-up imaging. The mean follow-up time after reintervention was 10.3 months (range, 7-13 mo). [ABSTRACT FROM AUTHOR]

Purpose: To assess the safety and effectiveness of transarterial radioembolization (TARE) in the treatment of hepatic metastases from pancreatic ductal adenocarcinoma (PDAC).Materials and Methods: A systematic search of the Embase and MEDLINE databases was conducted using keywords and Medical Subject Headings terms related to TARE and hepatic metastases from PDAC. Observational studies and clinical trials reporting overall survival (OS), hepatic progression-free survival (hPFS), or tumor response after TARE were included.Results: Eight studies, comprising 145 patients with metastatic PDAC, met the inclusion criteria. No randomized controlled trials were identified, and 4 studies were prospective. Forty-four (30.3%) patients underwent previous pancreatic resection, and 66 (45.5%) had extrahepatic metastases at the time of TARE. Most studies (n = 6) used resin microspheres for TARE. The pooled disease control rate was 69.4% at a median of 3 months. The median OS from the time of TARE ranged from 3.7 to 9 months. The median hPFS ranged from 2.4 to 5.2 months. There were 31 Grade 3-4 biochemical toxicities and 4 treatment-related deaths.Conclusions: The role of TARE in patients with hepatic metastases from PDAC remains unclear owing to low patient numbers, limited prospective data, and heterogeneity in the study design. Further prospective studies are required to evaluate the role of TARE in carefully selected patients with liver-only metastatic disease. [ABSTRACT FROM AUTHOR]

Objective This study evaluated changes in aortic neck diameter after endovascular aneurysm repair (EVAR) using a balloon-expandable stent (BES) endograft compared with a commercially available self-expanding stent (SES) endograft. We hypothesized that forces applied to the aortic neck by SES endografts may induce aortic neck enlargement over time and that such enlargement may not occur in aneurysm patients treated with a device that does not use a proximal SES. Methods This was a retrospective quantitative computed tomography (CT) image analysis of patients treated with the Nellix (Endologix, Irvine, Calif) BES (n = 49) or the Endurant II (Medtronic, Minneapolis, Minn) SES (n = 56) endograft from 2008 to 2010. Patients with preimplant, postimplant, and at least 1-year serial CT scans underwent quantitative morphometric assessment by two independent vascular radiologists blinded to the outcome results. Changes in the infrarenal neck over time were compared with the suprarenal aorta for each patient. Results Follow-up extended to 4.8 years for the BES and to 4.6 years for the SES, with no significant difference in median follow-up time (34 months for BESs and 24 months for SESs; P = .06). There were no differences in preimplant neck diameter (25.2 ± 0.9 mm vs 25.7 ± 1.1 mm; P = .54) or length (27.7 ± 3.7 mm vs 23.6 ± 3.7 mm; P = .12) between BESs and SESs at baseline. After implantation, neck diameter increased by 1.1 ± 0.5 mm in BES patients and 2.6 ± 0.5 mm in SES patients ( P = .07) compared with the preoperative diameter. At 3 years, neck diameter increased by 0.5 ± 0.9 mm in BES patients and by 3.8 ± 1.0 mm in SES patients ( P = .0002) compared with the first postoperative CT scan. The annual postimplant rate of increase in the infrarenal neck diameter was fivefold greater in SES patients (1.1 ± 0.1 mm/y) than in BES patients (0.22 ± 0.04 mm/y; P < .0001). There were no significant differences in the diameter of the suprarenal aorta at baseline or at 3 years and no differences in the annual rate of change in suprarenal aortic diameter between BES and SES endografts. Conclusions EVAR using SES endografts resulted in progressive infrarenal aortic neck enlargement, whereas EVAR using BES endografts resulted in no neck enlargement over time. These data suggest that infrarenal neck enlargement after EVAR with SES endografts is likely related to the force exerted by SES elements rather than disease progression in the infrarenal neck. [ABSTRACT FROM AUTHOR]

Objective Despite improvements in endograft devices, operator technique, and patient selection, endovascular repair has not achieved the long-term durability of open surgical aneurysm repair. Persistent or recurrent aneurysm sac flow from failed proximal sealing, component failure, or branch vessel flow underpins a significant rate of reintervention after endovascular repair. The Nellix device (Endologix, Irvine, Calif) employs a unique design with deployment of polymer-filled EndoBags surrounding the endograft flow lumens, sealing the aneurysm sac space and potentially reducing complications from persistent sac flow. This retrospective analysis represents the initial experience in consecutive patients treated with the device in real-world practice. Methods This study was performed at six clinical centers in Europe and one in New Zealand during the initial period after commercialization of the Nellix device. Patients underwent evaluation with computed tomography and other imaging modalities following local standards of care. Patients were selected for treatment with Nellix and treated by each institution according to its endovascular repair protocol. Clinical and imaging end points included technical success (successful device deployment and absence of any endoleak at completion angiography), freedom from all-cause and aneurysm-related mortality, endoleak by type, limb occlusion, aneurysm rupture, and reintervention. Results During a 17-month period, 171 patients with abdominal aortic aneurysms were treated with the Nellix device and observed for a median of 5 months (range, 0-14 months). The 153 male and 18 female patients with mean age of 74 ± 7 years had aneurysms 61 ± 9 mm in diameter with an average infrarenal neck length of 28 ± 15 mm and infrarenal angulation of 37 ± 22 degrees. Technical success was achieved in all but two patients (99%); one patient had a type Ib endoleak and another had a type II endoleak. Through the last available follow-up, type Ia endoleak was observed in five patients (3%), type Ib endoleak in four patients (2%), and type II endoleak in four patients (2%). There were eight limb occlusions (5%), among which seven were evident at the 1-month follow-up visit. Aneurysm-related reinterventions were performed in 15 patients (9%). There were no aneurysm ruptures or open surgical conversions. Conclusions This first multicenter postmarket report of the Nellix device for infrarenal abdominal aortic aneurysm repair demonstrates satisfactory results during the initial learning phase of this new technology. The rate of aneurysm exclusion was high, and frequency of complications was low. More definitive conclusions on the value of this novel device await the results of the ongoing Nellix EVAS FORWARD Global Registry and the EVAS FORWARD investigational device exemption trial. [ABSTRACT FROM AUTHOR]

For people enrolled in Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL), we sought to examine whether variation exists in the baseline medical therapy of different geographic regions and if any variations in prescribing patterns were associated with physician specialty. Patients were grouped by location within the United States (US) and outside the US (OUS), which includes Canada, South America, Europe, South Africa, New Zealand, and Australia. When comparing US to OUS, participants in the US took fewer anti–hypertensive medications (1.9 ± 1.5 vs. 2.4 ± 1.4; P < .001) and were less likely to be treated with an angiotensin–converting enzyme inhibitor or angiotensin II receptor blocker (46% vs. 62%; P < .001), calcium channel antagonist (37% vs. 58%; P < .001), and statin (64% vs. 75%; P < .05). In CORAL, the identification of variations in baseline medical therapy suggests that substantial opportunities exist to improve the medical management of patients with atherosclerotic renal–artery stenosis. [ABSTRACT FROM AUTHOR]

Purpose: To present the 12-month outcomes of the IN.PACT AV Access Study, a prospective, single-blind trial enrolling participants with obstructive de novo or restenotic native upper extremity arteriovenous dialysis fistula lesions treated with a drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA).Materials and Methods: After successful high-pressure PTA, participants at 29 international sites were randomized 1:1 to treatment with an IN.PACT AV DCB (n = 170) or standard uncoated PTA (n = 160). Outcomes at 12 months include target lesion primary patency (TLPP), defined as freedom from clinically driven target lesion revascularization or access circuit thrombosis; access circuit primary patency; number of reinterventions; and adverse events involving the access circuit.Results: At 12 months, TLPP was 63.8% (90/141) in the DCB group compared with 43.6% (61/140) in the PTA group (P < .001). The total number of reinterventions required to maintain TLPP through 360 days was 93 in the DCB group and 144 in the PTA group, with a 35.4% reduction in reinterventions when DCB was used. Access circuit thrombosis occurred in 2.9% (4/138) of the participants in the DCB group and in 6.2% (8/129) of those in the PTA group (P = .19). Time to TLPP was assessed using a multivariable analysis to identify the factors associated with loss of patency. The treatment device was the independent predictor with the largest effect, with a hazard ratio of 0.42 (95% confidence interval, 0.29-0.60; P < .001).Conclusions: TLPP was statistically significantly higher with DCBs than with standard PTA at 12 months, demonstrating the sustained and superior effectiveness of this device for the treatment of dysfunctional arteriovenous dialysis fistulae. [ABSTRACT FROM AUTHOR]

Objective: This study assessed preliminary results of the Ventana Fenestrated System (Endologix, Irvine, Calif) as an off-the- shelf integrated device for juxtarenal aortic aneurysm (JAA) or pararenal aortic aneurysm (PAA) endovascular repair. Methods: From November 2010 to April 2012, seven centers enrolled 31 patients with JAAs or PAAs ha an international clinical trial of the Ventana Fenestrated System. Clinical and laboratory evaluations were done predischarge and at 1 month, with continuing follow-up through 5 years. Core laboratory computed tomography imaging assessments were performed at 1 month and at each subsequent follow-up. Results: Patients (mean age, 73 years; 90% male) presented with mean aneurysm sac diameter of 6.0 cm. One patient with a short, reversed tapered infra-superior mesenteric artery (SMA) neck was enrolled under a protocol waiver. Among the 31 patients, one of five Ventana device models was used to preserve main renal arteries, the SMA, and celiac arteries; 20 patients (65%) received the same Ventana device (aligned fenestrations, 28-mm diameter). Median fluoroscopy and procedure times were 49 and 197 minutes, respectively; median hospital length of stay was 3.0 days. The 1-month clinical success rate was 94% (29 of 31), with no perioperative mortality. One intervention on day 26 was done to resolve limb kink/occlusion. A type IA endoleak and renal occlusion secondary to procedural device damage led to a reintervention on day 52 and dialysis at 5 months. During follow-up to 23 months, three non-aneurysm-related deaths occurred. No aneurysm rupture or conversion to open repair has occurred. One late migration with endoleak and covered renal stent fracture/occlusion occurred at 8 months in the patient with a short, reverse tapered infra-SMA neck performed under a protocol waiver, which was managed successfully with bilateral renal bypasses and endovascular repair of the endoleak. Another patient underwent late endovascular interventions to resolve bilateral renal stenosis. Conclusions: The multicenter experience of the Ventana Fenestrated System supports its safety and early-term to midterm effectiveness for the endovascular repair of JAAs and PAAs. This off-the-shelf integrated system permits endovascular treatment of JAAs or PAAs; however, further expanded clinical experience and longer-term follow-up are needed to more fully assess this device system. [ABSTRACT FROM AUTHOR]

Objective: Customized fenestrated endovascular stent grafts have been investigated as an alternative to open surgery for repair of more complex juxtarenal aortic aneurysms (JAAs). The substantial time required to design and manufacture these devices has led to the desire for a standardized fenestrated endovascular system. We report the initial pilot study results of a potential “off-the-shelf” fenestrated device system to assess its initial safety and feasibility for endovascular repair of JAAs and pararenal aortic aneurysms (PAAs). Methods: Following ethics committee approvals, consenting patients were evaluated for eligibility. Patients with aneurysms abutting or including the renal artery orifices who were not candidates for standard infrarenal endograft placement because of proximal aortic neck morphology were further assessed for anatomic suitability for this “off-the-shelf” device. There were a number of anatomic requirements, the most important being a stable infra-superior mesenteric artery aortic neck length ≥15 mm. Patients are assessed in-hospital and in follow-up at 1, 6, and 12 months, and annually thereafter to 5 years for adverse events and using contrast-enhanced computed tomography angiography with Core Laboratory interpretation of renal perfusion, device integrity, migration, endoleak, and aneurysm morphology. Results: Fifteen patients (87% male) with JAAs (93%) or PAAs (6.7%) presented at mean age of 77 years (range, 66-85 years) and with mean sac diameter of 5.9 cm (range, 5.1-7.9 cm). Four Ventana fenestrated stent graft models having aligned fenestrations (three models) or offset fenestrations (one model) and renal stent grafts were successfully implanted among the patients, and all renal and visceral arteries were preserved. Mean endovascular procedure time was 108 minutes (range, 71-212 minutes) with mean contrast usage and fluoroscopy time of 254 mL (range, 67-420 mL) and 55 minutes (range, 27-104 minutes), respectively. Five patients received blood products. Mean time to hospital discharge was 3.3 days (range, 2-9 days). In follow-up to 6 months and 1 year, no rupture, conversion to open repair, migration, type I/III endoleak, or renal loss/infarcts were observed. Two late nonaneurysm-related deaths have occurred. One secondary procedure for iliac limb kinking/occlusion and one secondary procedure for renal artery stenosis have been performed. Conclusions: Early experience supports procedural and initial postprocedural safety and demonstrates proof of concept for the off-the-shelf Ventana fenestrated system for the endovascular repair of JAAs and PAAs in selected patients. Continued follow-up and expanded multicenter clinical experience is warranted. [Copyright &y& Elsevier]

Abstract: Purpose: To compare the outcomes of planned superficial femoral artery (SFA) and common femoral artery (CFA) antegrade punctures in patients undergoing endovascular interventions for infrainguinal occlusive arterial disease in a single center. Materials and Methods: Between August 2010 and July 2011, consecutive patients who underwent antegrade puncture of CFA or SFA for infrainguinal occlusive disease were studied. Data including sheath size, rate of closure device usage, and complications relating to the arterial puncture were classified according to Society of Interventional Radiology (SIR) classification and analyzed retrospectively. Results: There were 199 antegrade arterial punctures, of which 28 (14%) were planned SFA punctures, performed in 184 patients. All patients had ultrasound-guided puncture. The sheath size ranged from 4 F to 8 F. In 2 of 28 (7%) SFA punctures, a closure device was deployed compared with 43 of 171 (25%) CFA punctures. Six bleeding complications were noted in the CFA puncture group (6 of 171 [3.5%]), of which 2 required urgent operations (repair of a pseudoaneurysm and evacuation of retroperitoneal hematoma). In comparison, only one minor groin hematoma was noted in the SFA puncture group; this did not require any further treatment. No thromboembolic complications were associated with SFA puncture. Conclusions: Planned antegrade SFA puncture under ultrasound guidance can be performed safely in selected cases with no added morbidity. Interventionalists should have a low threshold for considering antegrade SFA puncture as a first-line access site, especially in patients with a hostile groin. [Copyright &y& Elsevier]

The role of endovascular treatment of atherosclerotic renal artery disease is uncertain, particularly after the publication of the Angioplasty and Stenting for Renal Artery Lesions trial and other randomized trials. These trials have shown that nonselective treatment of patients with renal artery stenosis does not result in a benefit when compared with best medical therapy. However, all trials have identified a subgroup of patients who do respond favorably to revascularization. In particular, patients with a degree of chronic renal insufficiency, critical renal artery stenosis, and a recent decline in renal function are likely to respond positively to revascularization. Endovascular treatment of renal artery stenosis must be performed safely, particularly in the high-risk patient group with background chronic renal insufficiency. Atheroembolization occurs during renal artery revascularization, as demonstrated by ex vivo studies and the high embolic yield obtained in published series of protected renal artery revascularization. The evidence supporting embolic protection includes single-center series wherein excellent results for renal function preservation have been reported. One small, randomized, controlled trial demonstrated a significant benefit if both embolic protection and abciximab were used. There are unique demands on an embolic protection device in the renal artery circulation and a dedicated device has not been developed. Both distal filters and occlusion balloons have been successfully used. Both devices can normally be primarily passed through the stenosis, allowing the remainder of the procedure to be protected. Filters have the advantage of maintaining renal perfusion throughout the procedure. Distal occlusion balloons can capture embolic particles of all sizes although the clinical advantage is uncertain. [ABSTRACT FROM AUTHOR]

Objective: All current aortic endografts depend on proximal and distal fixation to prevent migration. However, migration and rupture can occur, particularly in patients with aortic necks that are short or angulated, or both. We present our initial clinical experience with a new sac-anchoring endoprosthesis designed to anchor and seal the device within the aneurysm sac. Methods: The initial worldwide experience using a new endoprosthesis for the treatment of aortic aneurysms (Nellix Endovascular, Palo Alto, Calif) was reviewed. The endoprosthesis consists of dual balloon-expandable endoframes surrounded by polymer-filled endobags designed to obliterate the aneurysm sac and maintain endograft position. Clinical results and follow-up contrast computed tomography (CT) scans at 30 days and 6 and 12 months were reviewed. Results: The endograft was successfully deployed in 21 patients with infrarenal aortic aneurysms measuring 5.7 ± 0.7 cm (range, 4.3-7.4 cm). Two patients with common iliac aneurysms were treated with sac-anchoring extenders that maintained patency of the internal iliac artery. Infusion of 71 ± 37 mL of polymer (range, 19-158 mL) into the aortic endobags resulted in complete aneurysm exclusion in all patients. Mean implant time was 76 ± 35 minutes, with 33 ± 17 minutes of fluoroscopy time and 180 ± 81 mL of contrast; estimated blood loss was 174 ± 116 mL. One patient died during the postoperative period (30-day mortality, 4.8%), and one died at 10 months from non-device-related causes. During a mean follow-up of 8.7 ± 3.1 months and a median of 6.3 months, there were no late aneurysm- or device-related adverse events and no secondary procedures. CT imaging studies at 6 months and 1 year revealed no increase in aneurysm size, no device migration, and no new endoleaks. One patient had a limited proximal type I endoleak at 30 days that resolved at 60 days and remained sealed. One patient has an ongoing distal type I endoleak near the iliac bifurcation, with no change in aneurysm size at 12 months. Conclusion: Initial clinical experience with this novel intrasac anchoring prosthesis is promising, with successful aneurysm exclusion and good short-term results. This new device platform has the potential to address the anatomic restrictions and limitations of current endografts. Further studies with a longer follow-up time are needed. [Copyright &y& Elsevier]

Abstract: Society is at a critical juncture in its relationship with the natural environment, a relationship in which tourism has growing significance. Yet, twenty years after the Brundtland Report, environmental policy has to date had little influence upon the workings of the tourism market, the supply and demand elements of which determine the ‘use’ or ‘non-use’ of nature. Inherent to the market is its environmental ethic, that is, the extent of our recognition of nature’s rights to existence. The thesis of this article is that whilst environmental policy may possibly have a greater influence in the future, it is the environmental ethics of the market that will be deterministic to the balance of the tourism-environment relationship. [Copyright &y& Elsevier]

Abstract: This paper illustrates examples of popliteal artery pathologies imaged with contrast enhanced magnetic resonance angiography (CE-MRA) and magnetic resonance imaging (MRI) at a single tertiary referral centre. Popliteal artery pathologies were identified in 1710 patients referred over a 6-year period with symptoms suggesting lower limb arterial occlusive disease. Common pathologies such as atherosclerotic occlusive disease, thromboemboli and aneurysm disease are discussed as well as unusual pathologies such as cystic adventitial disease, mycotic aneurysm and arterial entrapment. The combination of CE-MRA and the excellent soft tissue resolution of MRI allow detailed evaluation of arterial and peri-arterial pathologies, and facilitate appropriate management decisions. [Copyright &y& Elsevier]

A novel endovascular technique to reduce flow through a transjugular intrahepatic portosystemic shunt (TIPS) is described in a patient with severe hepatic encephalopathy. This technique allows controlled and potentially adjustable partial closure of the TIPS without thromboembolic risk. The patient experienced a dramatic clinical improvement after the procedure. [Copyright &y& Elsevier]

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The objective of this study was to evaluate the 1-year safety and effectiveness outcomes associated with the PQ Bypass DETOUR System (PQ Bypass, Milpitas, Calif) for the percutaneous bypass of long-segment femoropopliteal occlusive disease. This prospective, single-arm, multicenter trial enrolled patients with long-segment femoropopliteal arterial disease. The DETOUR System percutaneously deploys modular stent grafts to bypass femoropopliteal lesions through a transvenous route. Eligible patients included those with TransAtlantic Inter-Society Consensus C and D lesions >100 mm in length. The primary safety end point was the major adverse event (MAE) rate through 1 month, defined as the composite of death, clinically driven target vessel revascularization (CD-TVR), or major amputation. The primary effectiveness end point was stent graft patency through 6 months, defined as freedom from stenosis ≥50%, occlusion, or CD-TVR. During a 24-month period, 78 patients (82 limbs) were enrolled. The average core laboratory-measured lesion length was 371 ± 55 mm; 79 of 82 lesions (96%) were chronic total occlusions, and 55 of 82 lesions (67%) had severe calcification. The rates of technical and procedural success measured during the index procedure were both 96%, with satisfactory delivery and deployment of the device without MAEs in 79 of 82 limbs. Through 1 month, there were no deaths or amputations; CD-TVRs occurred in 2 of 81 limbs (3%), and freedom from MAEs was 98% (79/81). The 1-year Kaplan-Meier primary, assisted primary, and secondary patency rates were 81% ± 4%, 82% ± 4%, and 90% ± 3%, respectively. The ankle-brachial index increased an average of 0.25 ± 0.27 between baseline and 1 year (P <.001). Through 1 year, the Kaplan-Meier estimates of freedom from stent graft thrombosis, CD-TVR, and MAE were 84% ± 4%, 85% ± 4%, and 84% ± 4%, respectively. At 1 year, the Rutherford class improved in 77 of 80 limbs (96%), and 65 of 80 (81%) were asymptomatic. Deep venous thrombosis developed in 2 of 79 target limbs (3%) through 1 year, both at the femoropopliteal vein level. There were no instances of pulmonary embolism. The 1-year results from the DETOUR I trial show that the PQ Bypass DETOUR System is a safe and effective percutaneous treatment option for patients with longer, severely calcified, above-knee femoropopliteal lesions. [ABSTRACT FROM AUTHOR]

Purpose: This study sought to assess the performance of the LIFESTREAM balloon-expandable covered stent for the treatment of iliac artery atherosclerotic lesions.Methods: A total of 155 patients were treated in a prospective, single-arm study at 17 centers in the United States, Europe, and New Zealand. The primary endpoint was a composite of device- or procedure-related death or myocardial infarction (MI) over the course of 30 days, or target lesion revascularization (TLR), major amputation of the target limb, or re-stenosis through 9-months. Secondary endpoints included primary patency, TLR, sustained clinical success, quality of life, and major adverse events (MAE).Results: At 9 months, the primary composite endpoint rate was 16.2% (93.5% confidence interval [CI]: 10.6%-23.2%), primary patency was 89.1% (95% CI: 82.6%-93.7%), and freedom from TLR was 96%. There was a cumulative clinical improvement of at least one Rutherford category from baseline to 9 months of 90.5% (95% CI: 84.3%-94.9%). Quality of life, assessed by using the Walking Impairment Questionnaire (WIQ), demonstrated a mean change in total score from baseline through 9 months of 32.1 ± 26.84; overall, improvements were noted from baseline in each WIQ category. Seven of one-hundred fifty patients (4.7%; 95% CI: 1.9%-9.4%) experienced MAEs, but none were determined to be related to device or procedure.Conclusions: The LIFESTREAM balloon-expandable covered stent provided satisfactory 9-month clinical outcomes including a low rate of target lesion revascularization for the treatment of stenotic and occlusive lesions of the iliac arteries. [ABSTRACT FROM AUTHOR]