Suspected Symptomatic Infected Native Aortic Aneurysm Turns Out To Be Aortic Tumour Originating From Metastatic Cancer of Unknown Primary: A Case Report and Review of Literature.

Introduction: The non-specific clinical presentation of a primary aortic tumour may mimic infectious processes. Together with its rarity, this resemblance can complicate timely identification and pose diagnostic challenges. Report: The case of a 77 year old male patient complaining of abdominal pain radiating to the back, fatigue, and loss of appetite for a month, is presented. Contrast enhanced computed tomography showed a 47 mm infrarenal aortic aneurysm with peripheral enhancement. With suspicion of an infected native aortic aneurysm, open aortic repair was performed using a bovine pericardial Y prosthesis. The intra-operative biopsy revealed a malignant undifferentiated neoplasm, which later turned out to originate from metastatic cancer of unknown primary. The patient died six months later following comprehensive and extensive oncological treatment, which included radiotherapy and chemotherapy. Discussion: Given the scarcity of literature and challenges in classification, treatment recommendations rely on a multidisciplinary approach, involving surgery, radiotherapy, and chemotherapy. Despite the lack of established guidelines, early intervention, even in metastatic cases, may improve clinical outcomes. Surgical resection, whenever appropriate, is advocated, as it not only alleviates symptoms, but intra-operative histological sampling also aids in obtaining a definitive diagnosis.

An international, expert-based, Delphi consensus document on controversial issues in the management of abdominal aortic aneurysms.

OBJECTIVE: As a result of conflicting, inadequate or controversial data in the literature, several issues concerning the management of patients with abdominal aortic aneurysms (AAAs) remain unanswered. The aim of this international, expert-based Delphi consensus document was to provide some guidance for clinicians on these controversial topics. METHODS: A three-round Delphi consensus document was produced with 44 experts on 6 prespecified topics regarding the management of AAAs. All answers were provided anonymously. The response rate for each round was 100%. RESULTS: Most participants (42 of 44 [95.4%]) agreed that a minimum case volume per year is essential (or probably essential) for a center to offer open or endovascular AAA repair (EVAR). Furthermore, 33 of 44 (75.0%) believed that AAA screening programs are (probably) still clinically effective and cost effective. Additionally, most panelists (36 of 44 [81.9%]) voted that surveillance after EVAR should be (or should probably be) lifelong. Finally, 35 of 44 participants (79.7%) thought that women smokers should (or should probably/possibly) be considered for screening at 65 years of age, similar to men. No consensus was achieved regarding lowering the threshold for AAA repair and the need for deep venous thrombosis prophylaxis in patients undergoing EVAR. CONCLUSIONS: This expert-based Delphi consensus document provides guidance for clinicians regarding specific unresolved issues. Consensus could not be achieved on some topics, highlighting the need for further research in those areas.

Endovascular repair of pararenal and thoracoabdominal aortic aneurysms with inner and outer off-the-shelf multibranched endografts: A systematic review and meta-analysis.

BACKGROUND: During the last years a great progress has been noted in device technology and operator experience in treating complex aortic aneurysms. Fenestrated and branched custom-made devices require detailed preoperative planning and production time that can take ≤12 weeks. During this awaiting period, aortic-related mortality is increased. To overcome this limitation, off-the-shelf standardized multibranched devices were launched in the market for the treatment of pararenal and thoracoabdominal aortic aneurysms (TAAAs). Our aim was to evaluate systematically all the published studies of off-the-shelf endografts for the treatment of pararenal and TAAAs. METHODS: We performed a systematic review to identify all the eligible studies that reported outcomes to the off-the-shelf with inner or outer multibranched devices and then conducted a qualitative synthesis and meta-analysis of the results. The main outcomes were technical success, mortality, target visceral vessel instability, major adverse events, and reintervention rates. We estimated pooled proportions and 95% confidence intervals (CIs). RESULTS: A total of 1605 study titles were identified by the initial search strategy, of which 13 (8 t-Branch, 3 E-nside, 1 We-Flow, and 1 TAMBE) were considered eligible for inclusion in the meta-analysis. A total of 595 patients (70% male) were identified among the eligible studies. In terms of procedures, 64.4% were elective, 19.2% (13.4% outer multibranched group [OMG]; 6.1% inner multibranched group [IMG]) were emergent, and 16.4% (15.6% OMG; 0.8% IMG) were urgent. The pooled technical success was 92.1% (95% CI, 83.8%-96.4%) and 96.9% (95% CI, 92.5%-98.8%) for the outer and inner multibranched endografts, respectively. The pooled 30-day mortality was 10.4 % (95% CI, 6.6%-16.1%,) and 4.2% (95% CI, 2.0%-8.6%) for the OMG and IMG, respectively. The pooled 30-day and late target visceral vessel instability for the OMG was 3.5% (95% CI, 2.0%-6.1%) and 6.2% (95% CI, 4.7%-8.0%) and for the IMG 10.4% (95% CI, 4.5%-22.5%) and 1.6% (95% CI, 0.7%-3.3%) respectively. CONCLUSIONS: This pooled analysis indicated good technical success and mortality rates for both devices despite the high rate of urgent procedures. Pararenal and TAAAs can be treated safely using the included devices. However, further studies are required to draw additional conclusions for the IMG owing to the small sample size.

Reintervention Rate after Treatment with the INCRAFT AAA Ultra-Low-Profile Stent Graft System.

BACKGROUND: The INCRAFT stent graft system is an ultra-low-profile endograft for the exclusion of infrarenal aortic aneurysms. In the market approval studies, an increased rate of device-related complications was observed and the endograft was approved with mandated postmarketing investigations. Our aim was to analyze mid-term outcomes of a real-world patient cohort treated with the INCRAFT endograft. METHODS: Consecutive patients treated with the INCRAFT endograft between February 2015 and December 2022 at a single institution were included. In accordance with the Society for Vascular Surgery reporting standards, safety endpoints were reported and outcome endpoints included reinterventions, technical success, aortic-related and overall-mortality, endoleak, stent fracture, and endograft migration >5 mm. RESULTS: Eighty patients (85% male) with a mean age of 76 ± 7 years were included. Fifty-two patients (65%) were treated within the endograft's instruction for use. Mean aortic diameter was 59 ± 10 mm and 91% of the procedures were performed percutaneously. Mean follow-up (FU) was 37 ± 25 months and there was no aortic- or procedure-related mortality. Reinterventions occurred in 25 patients (31%) with a freedom from reintervention at 1, 3, and 5 years of 84%, 66%, and 55%. The most frequent reinterventions were limb graft stenting (23%) and type II endoleak embolization (14%). Limb occlusion rate was 9% and in 3 patients (4%) distal endograft migrations >5 mm occurred. Persisting type II endoleaks were observed in 29% and aneurysm diameter was stable in 41% and had shrunk in 38%. Three type III endoleaks (4%) developed during FU and 4 open conversions (5%) were necessary. No known risk factors, including treatment outside instruction for use, were predictive for reinterventions. CONCLUSIONS: Treatment of infrarenal aortic aneurysms with the INCRAFT stent graft system was safe and successful. Nevertheless, a substantial rate of reinterventions was necessary during FU to maintain endograft patency and prevent aneurysm growth.

Indication and Outcome of Late Open Conversion after Abdominal Endovascular Aortic Repair.

BACKGROUND: Endovascular aortic repair (EVAR) has become the standard of care for patients with infrarenal aortic aneurysms over the last 2 decades. Endograft technology and treatment of complications like endoleaks, graft migration, or graft occlusion developed over time. However, sometimes open surgical conversion maybe required. Our aim was to analyze the indications, the technical aspects and outcomes in patients who underwent open conversion after EVAR with different types and generations of endografts. METHODS: This retrospective single-center study reviewed all patients who underwent EVAR from 2004 to 2020. Open surgical conversions >1 month post EVAR were identified. Conversions for graft infection were excluded. Indications for conversion and operative technique were analyzed. Primary endpoint of the study was 30-day mortality. Secondary endpoints were re-interventions and follow-up mortality. RESULTS: During 2004 and 2020, 443 consecutive EVARs were performed, and 28 patients required open surgical conversion, with an additional 3 referred from other hospitals (N = 31). The median age was 75 (range 58-93); 94% were male. Conversion was performed after a median time of 55 months (range 16-209). Twenty patients underwent elective and 11 emergency conversion. Indications for open conversion were graft migration, respectively, disease progression with endoleak type Ia and/or Ib in 52% (16/31) and sac expansion due to endoleak type II in 26% (8/31). Of the 31 patients, 17 (55%) had at least one previous endovascular re-intervention. All patients met the device-specific instructions for use for each implanted endograft. In-hospital intervention rate was 16% (5/31). Thirty-day mortality rate was 3% (1/31) with one patient died due to multiorgan failure after rupture with complete endograft replacement. Five patients (16%) died during follow-up. Mid-term follow-up was 47.5 months (range 24-203) with estimated cumulative survival rates of 97%, 89%, and 84%, at 1, 3, and 5 years, respectively. CONCLUSIONS: Late open conversion remains a valuable treatment option and can be performed safely in elective and emergency setting with a low early mortality. Lifelong surveillance and prompt intervention when necessary are essential in ensuring optimal outcomes after EVAR and preventing the need for emergent conversions.

Post hoc analysis of the SuperB and Zilverpass trials for treatment of long and complex superficial femoral artery lesions.

OBJECTIVE: In two randomized controlled trials, the outcomes of endovascular treatment of complex femoropopliteal arterial lesions were compared with bypass surgery and considered a valid alternative treatment. The aim of this study was to compare both endovascular treatment options with the hypothesis that implantation of heparin-bonded self-expanding covered stents (Viabahn [SECS]) or drug-eluting stents (ZilverPTX [DES]) are related to similar clinical outcomes at 1-year follow-up. METHODS: In a post-hoc analysis, the SuperB trial and Zilverpass databases were merged. Patients in the endovascular treatment arms were included, and data was analyzed in an intention-to-treat (ITT) and a per-protocol (PP) fashion. Data included baseline and lesion characteristics, procedural details, and follow-up data. The primary endpoint of this study was primary patency at 1-year follow-up. The secondary endpoints were secondary patency, target lesion revascularization (TLR), limb loss, and all-cause mortality. RESULTS: A total of 176 patients were included; 63 in the SECS arm and 113 in the DES arm. Through 1-year follow-up, there were no significant differences in primary patency (ITT: 63.4% vs 71.1%: P = .183 and PP: 60.8% vs 71.1%; P = .100). Secondary patency rates were not significantly different in the ITT analysis (86.5% vs 95.1%; P = .054), but in the PP analysis, there was a significant difference in favor of the DES group (SECS, 85.6% vs DES, 95.1%; P = .038). There was no significant difference in freedom from TLR between groups (79.6% vs 77.0%; P = .481). No major amputations were performed in the SECS group, and two were performed in the DES group (1.8%). Survival rate was 98.2% in the SECS group, and 91.3% in the DES group after 1-year follow-up (P = .106). Based on diagnosis (intermittent claudication vs chronic limb-threatening ischemia) no differences between patients with intermittent claudication and chronic limb-threatening ischemia were observed in primary patency, secondary patency and freedom from TLR. CONCLUSIONS: Treatment of complex femoropopliteal arterial disease with the heparin-bonded Viabahn endoprosthesis and the Zilver PTX drug-eluting stent are related to similar primary and secondary patency, and TLR rates at 1 year, except for secondary patency in the PP analysis. This study further supports the endovascular treatment of long complex lesions in the femoropopliteal artery.

Intravascular Iliac Artery Lithotripsy to Facilitate Aortic Endograft Delivery: Midterm Results of a Dual-Center Experience.

PURPOSE: To assess the feasibility and safety of intravascular lithotripsy (IVL) for enabling transfemoral abdominal (EVAR), thoracic (TEVAR), and thoracoabdominal (BEVAR) endovascular aneurysm repair in patients with narrow and calcified iliac arteries. MATERIALS AND METHODS: Consecutive patients treated with IVL for severe calcified and narrowed iliac access before EVAR, TEVAR, or BEVAR between November 2020 and June 2022 were retrospectively evaluated. All anatomical iliac characteristics were acquired by multi-planar reconstruction of preoperative computed tomography angiography (CTA). The hostility of the vascular accesses was classified based on Peripheral Arterial Calcium Scoring System (PACSS) and calcified access severity score (CASS), a new score considering both anatomical (calcium grade and length, minimum lumen diameter [MLD], and tortuosity index) and aortic stent-graft (SG/MLD index) parameters. Primary endpoint was technical success defined as successful aortic endograft delivery and deployment without iliac rupture. Freedom from complications and primary patency were additionally analyzed. RESULTS: Twenty-eight iliac axes were treated with IVL (8 bilateral) in 20 patients (mean age 74.5±6.7 years) with a mean follow-up of 26.5±6.2 (range 17-36) months. Ten patients underwent EVAR: 3 TEVAR, and 7 BEVAR procedures. In 14 patients (70%), aneurysm disease was associated with symptomatic aorto-iliac occlusive disease (AIOD), with Rutherford class III to IV. The PACSS was grade IV in 89% of the cases and the CASS (mean 14±2) was grade III to IV in all cases. The stent-graft (SG) outer diameter (5.60±1.65 mm) was significantly larger by 50% than MLD (3.96±1.20 mm), with an SG/MLD index of 1.50±0.51 (p<0.001). Technical success was 100%. No dissection, rupture, or distal embolization occurred. One (3.4%) bail-out stenting was necessary as endoconduit after IVL treatment. One month CTA showed that postoperative luminal gain increased by 93% (p<0.001). An improvement of 2 Rutherford classes occurred in all AIOD patients with a primary patency of 100% at last follow-up. CONCLUSIONS: This study shows the safety and feasibility of IVL as a valuable option to treat narrow and calcified iliac arteries to facilitate endograft delivery. Further studies will be useful to confirm these results. CLINICAL IMPACT: In this article, the use of intravascular iliac artery lithotripsy to facilitate aortic endograft delivery is explored. The presence of iliac severe calcifications still represents a contraindication for aortic endovascular repair. Intravascular lithotripsy increases the feasibility and safety of endovascular aortic procedures, facilitating endograft delivery and reducing the risk of iliac rupture and/or dissections by improving vessel compliance and luminal gain. This novel vessel preparation could be an alternative to "paving and cracking" and/or iliac conduits. This study describes a new score to classify the severity of iliac calcifications, considering anatomical parameters and the profile of aortic endografts delivery system.

ZILVERPASS Study: ZILVER PTX Stent versus Prosthetic Above-the-Knee Bypass Surgery in Femoropopliteal Lesions, 5-year Results.

PURPOSE: To report the 60-month safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to prosthetic above-the-knee bypass for the treatment of symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions. MATERIALS AND METHODS: Patients were enrolled between October 2013 and July 2017. One of the secondary outcomes was primary patency at 60 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio < 2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass at 60 months. Survival rates after 5 years were also analyzed. RESULTS: 220 patients (mean age 68.6 ± 10.5 years; 159 men) were included and randomized to ZILVER PTX (n = 113, 51.40%) or BYPASS group (n = 107, 48.60%). The 60-month primary patency rate was 49.3% for the ZILVER PTX group versus 40.7% for the bypass group (p = 0.6915). Freedom from TLR was 63.8% for the ZILVER PTX group versus 52.8% for the bypass group (p = 0.2637). At 5 years, no significant difference in survival rate could be seen between the ZILVER PTX and the bypass group (69.1% vs. 71% respectively, p = 0.5503). CONCLUSION: Even at 5 years, non-inferior safety and effectiveness results of the ZILVER PTX could be seen. These findings confirmed that the use of ZILVER PTX stents can be considered as a valid alternative for bypass surgery when treating long and complex femoropopliteal lesions.

ZILVERPASS Study: ZILVER PTX Stent vs. Bypass Surgery in Femoropopliteal Lesions, 3 year results and economic analysis.

BACKGROUND: To report the 3-year safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to surgical bypass and to conduct a health economic analysis up to 3-year follow-up of the two treatment modalities. METHODS: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs. surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.40%) or the bypass treatment group (107, 48.60%). One of the secondary outcomes was primary patency at 3-year, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. An economic analysis was conducted to analyze the cost differences between ZILVER PTX and bypass, which shows the perspective of the public authority/organization that pays for healthcare in the two countries (payor), Germany and USA. RESULTS: The 3-year primary patency rate was 53.30% (95% CI 61.40% to 45.20%) for the ZILVER PTX group vs. 58.20% (95% CI 67.10% to 49.30%) for the bypass arm (P=0.9721). Freedom from TLR at 3-year was 62.80% (95% CI 72.60% to 53%) for the ZILVER PTX group vs. 65.30% (95% CI 75.40% to 55.20%) for the bypass group (P=0.635). There was also no significant difference (P=0.358) in survival rate at 3-year between the ZILVER PTX group 78.50%, (95% CI to 87.70% to 69.30%) and the bypass group 87.40% (95% CI 97.6% to 77.2%). None of the deaths was categorized as related to the procedure or device. The economic analysis, taking into account procedural-, hospitalization- and reintervention costs, showed a clear cost-benefit for Zilver PTX in both investigated countries up to 3-year follow-up: Germany (Bypass €9446 per patient versus ZILVER PTX €5755) and USA (Bypass $26,373 per patient versus ZILVER PTX $19,186). CONCLUSIONS: The non-inferior safety and effectiveness results of the ZILVER PTX stent were associated with lower costs for the payer and confirmed that ZILVER PTX stent treatment can be considered as a valid alternative for bypass surgery in long and complex femoropopliteal lesions.

Two-year target vessel-related outcomes following use of off-the-shelf branched endografts for the treatment of thoracoabdominal aortic aneurysms.

OBJECTIVE: The aim of this study was to assess clinical outcomes and target vessel patency through 2 years following thoracoabdominal aortic aneurysms (TAAA) repair with the off-the-shelf Zenith t-Branch Thoracoabdominal Endovascular Graft (William Cook Europe). METHODS: This post-market observational study was conducted at three European sites with ambispective enrollment from 2012 to 2017. Patients underwent endovascular TAAA repair with the t-Branch graft and bridging stent grafts (BSGs) for the celiac (CA), superior mesenteric (SMA), left renal (LRA), and/or right renal (RRA) arteries. Follow-up was through 2 years, per sites' standard of care. Procedural and 1-year results were reported previously. RESULTS: Eighty patients (mean age, 71.0±7.4 years; 70.0% men) were enrolled; six patients had symptomatic TAAAs, and 15 patients had contained ruptures. Technical success was achieved in 98.8% of patients (79/80). Median follow-up was 22.2 months (interquartile range, 9.2-25.1 months). At 24 months, Kaplan-Meier (KM) freedom from all-cause and aneurysm-related mortality were 78.5% and 98.6%, respectively. Beyond 12 months, 38 adverse events occurred in 20 patients, including two aortic ruptures (one study aneurysm and one non-study aneurysm) and six deaths (none aneurysm-related, as reported by the site). Compared with postprocedure, maximum aneurysm diameter decreased (>5 mm) in 84.6% (44/52), remained unchanged in 3.8% (2/52), and increased (>5 mm) in 11.5% (6/52) of patients with imaging follow-up after 12 months. No conversions to open repair, and no t-Branch graft or other endograft component migration or integrity issues were reported. No loss of patency was reported in the t-Branch or iliac limb grafts throughout the study. Throughout study duration, four patients had five imaging-reported BSG compressions, none of which required secondary intervention. KM freedom from secondary intervention was 76.3% at 24 months. Fourteen target vessel-related secondary interventions were performed, primarily consisting of stent placement for endoleak, stenosis, or occlusion. KM freedom from loss of primary patency was 94.8%, 100%, 91.3%, and 89.3% for the CA, SMA, LRA, and RRA, respectively, at 24 months. KM freedom from loss of secondary patency in the CA, SMA, LRA, and RRA were 96.3%, 100%, 98.2%, and 98.3% at 24 months, respectively. A total of 298 vessels were targeted, of which 12 were occluded over the study period. CONCLUSIONS: Primary and secondary target vessel patency rates through 2 years demonstrated durable repair with the t-Branch graft in patients treated for symptomatic or asymptomatic thoracoabdominal aortic aneurysms.

Intravascular lithotripsy: a powerful tool to treat peripheral artery calcifications.

Calcification represent one the most important predictors of treatment failure of endovascular therapy for peripheral arterial disease, since it restricts wall expansion and acts as a barrier for drug uptake. It also increases complications after PTA like dissection, perforation, and embolization with poor outcomes. Intravascular lithotripsy (IVL) is a novel approach for the treatment of vascular calcifications with the goal to optimize outcome in patients with PAD and heavy calcifications. This review gives an overview of the currently published articles regarding the use of IVL within the vascular field. In conclusion, IVL is a safe and effective approach in the treatment of highly calcified arteries with excellent results and low rates of related complications, such as embolization, dissection, and perforation. However, it seems to require adjunctive therapies to enhance long-term patency as well as an adequate sizing (1.1:1 ratio). Its use to facilitate access of large-bore devices seems to be valuable by changing vessel compliance and achieving luminal gain. Further studies are nonetheless mandatory.

Performance of the Gore VBX Balloon Expandable Endoprosthesis as Bridging Stent-Graft in Branched Endovascular Aortic Repair for Thoracoabdominal Aneurysms.

PURPOSE: Bridging stent stability is crucial for efficacy and safety of branched aortic endovascular repair (bEVAR) of thoracoabdominal aortic aneurysms (TAAAs). In this study, we assess the performance of the new Viabahn Balloon-Expandable endoprosthesis (VBX) in bEVAR. Based on our learning curve we give recommendations for a safe and effective use of the device. MATERIALS AND METHODS: We prospectively collected the data of patients with TAAAs undergoing bEVAR between December 2017 and December 2019. All patients with implantation of at least 1 VBX stent-graft as bridging stent were included in our single-center analysis. Demographic, comorbidity, and computed tomography angiography (CTA) data of 112 patients were retrospectively evaluated. Primary endpoint was a composite of branch-related technical success and freedom from target vessel instability. Secondary endpoints were clinical and ongoing clinical success. RESULTS: Primary endpoint: technical success was achieved in all patients (100%) with a freedom from target vessel instability of 96.3% after a median follow-up of 18 months. Overall mortality was 13.4% (n=15) and 13 patients underwent secondary interventions, 12 of them are still alive and 1 suffered from aneurysm sac expansion, consequently an ongoing clinical success of 75.9% was reached. After modification of the implantation technique during the course of the study by selecting longer stent lengths after accurate estimation of vessel curvature and expected adaptation of the flexible endoskeleton to the specific anatomical conditions, no type Ic endoleaks were observed in the last 70 cases. CONCLUSIONS: The VBX stent-graft can be safely used as bridging stent for branched thoracoabdominal repair. However, learning curve should be considered to avoid type Ic endoleak and edge stenosis. Based on this experience longer landing zones and 2-step deployment of VBX are useful for successful bridging also of challenging target vessels.

Early and midterm results from a postmarket observational study of Zenith t-Branch thoracoabdominal endovascular graft.

OBJECTIVE: We have reported the short-term outcomes regarding the safety of the off-the-shelf Zenith t-Branch multibranched thoracoabdominal stent-graft (William Cook Europe ApS, Bjaeverskov, Denmark) in a postmarket, multicenter study. METHODS: Patients who had been treated with the t-Branch device from September 2012 to November 2017 at three European centers were either prospectively or retrospectively enrolled in the present study. Device implantation and postprocedural follow-up were performed according to the standard of care at each center. The primary objectives of the present study were to assess the procedure-related mortality and morbidity at 30 days and 1 year and to assess the presence of endoleaks, device integrity, and stent-graft and branch vessel patency. RESULTS: A total of 80 patients were included in the present study (mean age, 71.0 ± 7.4 years; 70.0% male). Most (n = 77) had been treated for thoracoabdominal aortic aneurysms (TAAAs) and the rest for dissection (n = 3). Most TAAAs were stable (72.7%; 56 of 77). The remaining TAAAs were symptomatic (7.8%; 6 of 77) or had a contained rupture (19.5%; 15 of 77). The t-Branch device was successfully deployed in 79 patients. In one patient, the delivery system of the device could not be advanced through the iliac artery. Within 30 days, one patient had died (1.3%). At 1 year, seven patients had died (8.8%), and no aortic rupture or conversion to open surgery had been reported. The 30-day neurologic events included stroke in three patients (3.8%), paraplegia in one (1.3%), and paraparesis in six patients (7.5%). Secondary interventions were required in nine patients (11.3%) during follow-up. Postoperative endoleaks were observed in 37 of 72 patients (51.4%), including type II endoleak in 30, type Ia in 4, and type III endoleak in 6 patients. At 1 year, endoleaks had been reported in 20 patients (16 with type II and 4 with type III). The t-Branch main body graft patency was 100% throughout the 1-year follow-up period. At 30 days after the procedure, all celiac and superior mesenteric artery branches were patent and one left renal and one right renal branch were occluded. At 1 year, occlusion had developed in three bridging stent-grafts for the celiac artery, one for the left renal artery, and two for the right renal artery. CONCLUSIONS: The t-Branch device appears safe, with good 30-day and 1-year mortality and morbidity in the present study, including both stable and symptomatic cases.

2-Year Outcomes of the Eluvia Drug-Eluting Stent for the Treatment of Complex Femoropopliteal Lesions.

OBJECTIVES: The aim of this study was to evaluate the 2-year performance of a polymer-based drug-eluting stent (DES) for the treatment of complex femoropopliteal lesions. BACKGROUND: Despite the promising early outcomes of the Eluvia DES, the long-term safety and efficacy of the device in a real-world scenario remain unclear. METHODS: Between March 2016 and December 2018, 130 patients (137 lesions) with symptomatic femoropopliteal disease were included in this study. The primary outcome measure of this analysis was primary patency. Secondary patency, freedom from target lesion revascularization, freedom from surgical conversion, and overall mortality and morbidity were additionally analyzed. RESULTS: The majority of patients presented with lifestyle-limiting claudication (n = 90 [69%]). The mean lesion length was 194 ± 108 mm, 74% of the lesions (n = 101) were chronic total occlusions, and 72% (n = 99) were calcified. Moderate to severe calcification (Peripheral Arterial Calcium Scoring Scale score 3 or 4) was observed in 48% of the treated vessels (n = 67). At 24 months, the Kaplan-Meier estimate of primary patency was 71%, whereas both the secondary patency rate and freedom from target lesion revascularization were 80%. Overall survival amounted to 85%. Freedom from major amputation was 98%, while freedom from surgical conversion was 89%. Degeneration of the vessel wall was observed in 27 lesions (20%). CONCLUSIONS: In this study, use of the Eluvia polymer-based DES for the treatment of complex femoropopliteal disease showed promising 2-year results. Nonetheless, a relatively high rate of vessel wall degeneration was observed after DES deployment.

One-year outcome of the paclitaxel-eluting Legflow balloon catheter in the treatment of long and complex femoropopliteal lesions.

BACKGROUND: The aim of this study is to investigate the efficacy of the paclitaxel-eluting Legflow balloon catheter in the treatment of "real-world" long and complex femoropopliteal lesions. METHODS: The REFLOW study was a prospective, multi-national, non-randomized, single arm study evaluating the safety and efficacy of the Legflow paclitaxel-eluting balloon dilatation catheter in the treatment of stenotic or occlusive lesions >150 mm long in the femoropopliteal arteries of symptomatic patients (Rutherford 2-5). A total of 120 study subjects were enrolled in a period of 30 months, between October 2015 and May 2018. The mean age was 71.1 years and 79 patients were men (65.8%). Mean lesion length was 216.1 mm. 45.0% of the lesions were occluded, whereas 55.0% were stenotic. Primary endpoint was primary patency at 12 months, defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 12 months. RESULTS: Technical and procedural success (<30.0% residual angiographic stenosis without major complications) was achieved in all 120 cases (100.0%). Primary patency was 84.6% at 6 months and 71.1% at 1 year. Freedom from TLR was 79.9% at 1 year. CONCLUSIONS: If longer term follow-up confirms there is no safety-concern on these paclitaxel device, the excellent results of the newer drug-eluting devices, and the Legflow paclitaxel-eluting balloon in particular, is a valid and effective alternative to treat long and complex "real-world" femoropopliteal lesions.

One-Year Results From the SURPASS Observational Registry of the CTAG Stent-Graft With the Active Control System.

Purpose: To report the outcomes from the observational SURPASS registry, which was created to assess the performance of the Conformable TAG (CTAG) stent-graft with the Active Control System (ACS) in patients undergoing thoracic endovascular aortic repair (TEVAR) in a real-world setting. Materials and Methods: The SURPASS registry (ClinicalTrials.gov; identifier NCT03286400) was an observational, prospective, single-arm, post-market, international study that enrolled patients undergoing TEVAR using the CTAG with ACS for both acute and chronic thoracic aortic disease between October 2017 and July 2018. The CTAG with ACS features 2-stage deployment of the stent-graft and an optional angulation mechanism that modifies only the proximal end of the stent-graft. During the observation period, 127 patients (mean age 67.1±12.1 years, range 27-86; 92 men) were enrolled and treated for an array of aortic pathologies, including chronic and acute lesions and 4 ruptured descending thoracic aneurysms. The primary outcome of this study was technical success; secondary outcomes were clinical success and major adverse events at 30 days and 12 months. The numbers of 2-stage device deployments and applications of the angulation mechanism were recorded, along with the reasons for use. Results: Technical success of the TEVAR was 97.6% owing to unintentional partial coverage of supra-aortic branches in 3 cases (the vessels were patent on imaging). The stent-graft was repositioned at its intermediate diameter in 79 patients (62.2%), and the angulation feature was applied in 64 cases (50.4%), mainly to improve proximal wall apposition and orthogonality in the aorta. The desired effect was achieved in 60 cases (93.8%). There was no device compression, bird-beak configuration, fracture, or graft occlusion. The 30-day and 12-month clinical success rates were 97.6% and 92.9%, respectively. There were 3 aorta-related deaths at 30 days and a further 3 at 12 months. Fatalities were due to a retrograde type A dissection (0.8%), paraplegia, bowel ischemia, sepsis in the setting of a mycotic aneurysm, aneurysm rupture post aortoesophageal fistula, and multiorgan dysfunction syndrome. Three endoleaks (2 type Ia and 1 type III) required reintervention. Conclusion: In the SURPASS registry, the use of the CTAG device with ACS showed promising outcomes despite the challenging pathologies. The new delivery system enables a controlled staged delivery with in situ adjustments during positioning, facilitating the treatment of complex aortic disease.

Longer bridging stent-grafts in iliac branch endografting does not worsen outcome and expands its applicability, even in concomitant diseased hypogastric arteries.

BACKGROUND: The iliac side branch device (IBD) is a valid method for the treatment of abdominal aorto-iliac aneurysms. However there is still a lack of evidence regarding the optimal length of the bridging stent graft (BSG) since aneurysmal degeneration of the hypogastric artery (HA) is an exclusion criterion. The aim of this study was to analyse the impact of longer BSG compared to the widely used 38mm stent-grafts in terms of reintervention rate and primary patency. METHODS: We retrospectively analyzed our prospectively collected database of all patients who underwent an endovascular aneurysm repair using an IBD in our center between April 2005 and May 2015. The used BSGs were divided into 2 groups. In group A, the BSG was ≤38 mm, and group B>38 mm. The primary endpoint was BSG-related events, including stenosis, occlusion or endoleak. Secondary endpoints were technical success, primary patency and 30-day mortality. RESULTS: Two hundred sixty IBDs were implanted in 215 consecutive patients. Ninetyseven (37%) in group A and 163 (63%) in group B. The technical success rate was 100%. The 30-day mortality was 1% (N.=1) and 1.2% (N.=2) respectively for group A and B (P=0.8). The freedom from BSG-related events amounted to 84% at 60 months for the total cohort. The comparison between the two groups shows no significant difference, while a slight favorable trend for group B (75% vs. 91% at 60 months, P=0.081) was observed. No differences were found as to primary patency (96% and 99% at 60 months respectively for group A and B, P=0.237). CONCLUSIONS: The use of longer stent-grafts (>38 mm) seems not to affect the performance of BSG even in the long run, expanding the indication for IBD also for aneurysms of the hypogastric artery.

Surgical versus endovascular revascularization of subclavian artery arteriosclerotic disease.

BACKGROUND: Endovascular treatment offers an alternative, less invasive approach to open repair for subclavian artery atherosclerotic disease (SAAD). However, only few studies compared the outcomes of both strategies in the long run. This study reports on the performance of endovascular and surgical revascularization for SAAD. METHODS: A retrospective review was conducted on patients treated for SAAD at two institutions between January 1998 and December 2015. Primary outcome of this study was the composite endpoint of reintervention-free survival (RFS) defined as time to reintervention and/or death from any cause. Secondary endpoints included primary patency (PPR) and secondary patency (SPR) rates as well as overall survival and time to reintervention. RESULTS: Surgical treatment was the preferred treatment option in 27 (25%) patients, while 83 (75%) patients underwent primary stent therapy. The median follow-up was 87 months (interquartile range [IQR]: 38 to 151) in the surgical group and 27 (IQR: 12 to 59) in the endovascular (P=0.0001). Severe arterial wall calcification was more commonly observed in the surgical arm (P<0.0001), while mild and moderate calcification in the endovascular (P=0.0004 and P=0.014). Vessel occlusion was more frequent among patients treated surgically (100% vs. 34%, P<0.0001). At 98 months RFS was significantly higher after surgical treatment (95% vs. 54%, HR: 8.4, 95% CI: 3.9 to 18.1, P=0.0002). Although overall survival did not differ significantly between the two groups (HR: 4.28, 95% CI: 0.86 to 21.22, P=0.093), open repair was associated with reduced reintervention rate (HR: 12.04, 95% CI: 4.98 to 29.12, P=0.001). The PPR at 98 months following surgical and endovascular therapy amounted to 96% and 65% (HR: 12.87, 95% CI: 5.44 to 30.44, P=0.0008) respectively. No significant difference was observed regarding the SPR between the two groups (100% vs. 95%, P=0.090). CONCLUSIONS: Surgical treatment was associated in this cohort with increased patency and a significant reduction of reinterventions compared to the endovascular approach.

Is vessel prep necessary before treating the superficial femoral artery?

The standard of care for treating symptomatic peripheral arterial disease has been percutaneous transluminal angioplasty with or without stenting over the last couple of years. This endovascular treatment of claudicants or patients with critical limb ischemia has increased in numbers and has even surpassed open surgery. Our daily practice has evolved to an endovascular-first approach, especially in the femoropopliteal region, being the most frequently treated vessel. However, neointimal hyperplasia and elastic recoil leading to target lesion restenosis or occlusion after initial successful treatment is not uncommon. In recent years, drug-eluting technologies on balloons or stents have been investigated as a potential solution for this problem with excellent results compared to plain-old balloon angioplasty. Nonetheless in the majority of those trials, the bailout stenting rate increased with lesion complexity, albeit it in long or heavily calcified lesions due to flow-limiting dissections, elastic recoil or the calcium barrier preventing adequate drug uptake. There is a need for vessel preparation in order to ameliorate drug delivery, especially in complex lesions. Multiple devices are available to prepare even the most challenging lesions for drug uptake or stenting, by achieving maximal luminal gain and by minimizing dissections. This review aims to give an overview of the most common modalities for vessel preparation in the superficial femoral artery beside plain old balloon angioplasty together with an overview of the current literature of each device in the superficial femoral artery.