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Objective: The prevalence of chronic limb threatening ischaemia (CLTI) is increasing worldwide, resulting in the need for more patients to undergo revascularisation, especially for below the knee pathology. Nevertheless, prospective data on below the knee endovascular interventions are lacking. The aim of the study was to provide large scale, real world data on procedural and short term outcomes of popliteal and infrapopliteal endovascular interventions in patients with CLTI., Methods: This study is an analysis of the first 1 000 interventions of the Dutch Chronic Lower Limb Threatening Ischaemia Registry (THRILLER). It includes all patients with CLTI undergoing popliteal or infrapopliteal endovascular revascularisation in seven hospitals in the Netherlands. The primary outcomes were limb salvage and amputation free survival (AFS) at three months estimated by the Kaplan-Meier method. Secondary outcomes were procedural complications and primary patency., Results: Between February 2021 and July 2023, 1 000 endovascular procedures were performed in 840 patients (947 limbs), treating 486 popliteal and 1 209 tibial lesions. Wound, Ischaemia, and foot Infection (WIfI) stages 1 - 4 were present in 16.8%, 17.2%, 25.4%, and 40.6% of the limbs, respectively. Technical success was hampered by arterial perforation, acute thrombosis, and distal embolisation in 8.7%, 1.0%, and 2.3% of the interventions, respectively. Limb salvage was 100.0%, 96.9%, 94.9%, and 86.1% (p < .001), whereas AFS was 96.9%, 93.2%, 86.6%, and 76.4% for WIfI stages 1 - 4 at three months (p < .001), respectively. Primary patency at the 6 - 8 week visit was 86.4% for popliteal and 74.3% for tibial lesions, respectively., Conclusion: THRILLER presents a large prospective database on outcomes of endovascular CLTI interventions. Popliteal and infrapopliteal endovascular revascularisation for CLTI is safe. Interventions with initial technical success have high rates of limb salvage and survival at three months. The WIfI classification provides a reliable instrument to predict limb salvage and AFS independently at three months., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Type B aortic dissection (TBAD) presents a complex clinical challenge requiring coordinated, multidisciplinary care to optimize patient outcomes. While rapid intervention is crucial for complicated TBAD, the optimal management of uncomplicated cases remains less well-defined. Historically, uncomplicated TBAD was managed medically, but recent years have seen a shift toward selective interventional approaches. Updated American and European guidelines now recommend thoracic endovascular aortic repair (TEVAR) for high-risk, uncomplicated cases, characterized by factors including a large aortic diameter, large entry tears, or persistent pain. Observations from the International Registry of Acute Aortic Dissection highlight a significant shift toward endovascular management and reduced mortality over time. The acute dissection stentgraft or best medical treatment and investigation of stent grafts in aortic dissection trials suggested that pre-emptive TEVAR may benefit certain high-risk patients by promoting favorable aortic remodeling. However, routine use of TEVAR in all uncomplicated cases is presently still controversial due to risks such as stroke and spinal cord ischemia, which emphasize the importance of careful patient selection. Current evidence supports a tailored approach that integrates clinical and imaging risk factors to identify patients most likely to benefit from pre-emptive TEVAR. In addition, ongoing randomized controlled trials, including IMPROVE-AD, SUNDAY, and EARNEST, will hopefully provide critical data on the risks and benefits of TEVAR in uncomplicated TBAD. Moving forward, interdisciplinary collaboration among different medical and engineering specialties, and refined risk stratification will be essential to advance TBAD management, enhancing outcomes for both complicated and uncomplicated cases., (Copyright © 2025 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Aorto-bronchial or aorto-pulmonary fistulas (ABPF) are a rare but life-threatening complication following thoracic endovascular aortic repair (TEVAR). This narrative review aims to provide an overview of the current trends and available evidence on ABPF following TEVAR, evaluating risk factors, diagnostic approaches, and possible preventive and therapeutic strategies., Methods: Relevant publications on post-TEVAR ABPF were selected through a literature search on PubMed. Studies providing data on post-TEVAR ABPF concerning pathogenesis, clinical presentation, diagnostic tools, surgical approaches, and outcomes were included., Results: The literature search obtained 169 articles. After selection, 37 studies, published between 2000 and 2024, remained for analysis. The primary symptom of ABPF is typically hemoptysis, which may be recurrent or persistent. The diagnostic pathway for ABPF encompasses medical history, clinical evaluation, blood tests, sputum and blood cultures. Computed tomography angiography is the first-line imaging modality in suspected ABPF, while bronchoscopy is reserved for hemodynamically stable patients. Moreover, 18-fluoro-deoxyglucose positron emission tomography can aid in the diagnosis of graft infection. Post-TEVAR ABPF are associated with multiple risk factors, mainly patient-specific clinical conditions (i.e. chronic inflammatory conditions, underlying mediastinal oncologic pathologies, and infectious diseases) and anatomical characteristics, mainly large aortic aneurysms, severe aortic tortuosity, and an extensive periaortic hematoma. Strategies to minimize the risk of ABPF formation include appropriate device oversizing, long sealing zones, limited extent of aortic coverage, selective hematoma evacuation, and strict adherence to sterility and antibiotic prophylaxis. Radical surgical interventions have shown superior outcomes compared to endovascular approaches, which may be adopted as initial step to stabilize the patient in a staged treatment., Conclusion: Post-TEVAR ABPF is a rare and life-threatening condition. Literature is scarce and a deeper understanding of risk factors, diagnostic pathways, and therapeutic strategies is essential for the prevention and management of ABPF secondary to TEVAR., (Copyright © 2025 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objective: There is a lack of consensus regarding the optimal antithrombotic therapy (ATT) after popliteal and infrapopliteal (PIP) endovascular therapy (EVT). Currently, dual antiplatelet therapy (DAPT) for 3 months and single antiplatelet therapy (SAPT) are the most prescribed regimens in the Netherlands. Thus far, no randomized comparison has been performed on the optimal ATT approach. Therefore, this study compared the efficacy and safety of 3-month DAPT with SAPT following PIP EVT., Design: Retrospective analysis of prospectively collected data from a multicenter registry., Methods: The Dutch chronic lower limb-threatening ischemia registry (THRILLER) collected prospective data on patients enrolled between January 2021 and October 2023. As for ATT, only patients prescribed antiplatelet therapy (APT), were included in this analysis. The primary efficacy outcome was a composite of 3-month major adverse cardiovascular events (MACEs, ie, myocardial infarction, cerebrovascular event, cardiovascular death), major adverse limb events (MALEs, ie, major amputation, reintervention), and non-cardiovascular death. Secondary efficacy outcomes were 3-month MACE, MALE, and all-cause mortality. The primary safety outcome was major bleeding according to the 'Thrombolysis In Myocardial Infarction' (TIMI) classification. Descriptive statistics and Cox proportional hazard models were applied., Results: In total, 460 of 840 THRILLER patients used DAPT or SAPT as ATT and were therefore included in the analysis. Of these, 322 (70%) received DAPT and 138 (30%) received SAPT. In total, 73 (15.9%) primary efficacy outcomes were observed of which 21 (15.2%) events in the SAPT group and 52 (16.1%) events in the DAPT group. No significant differences were observed between SAPT and DAPT for the primary efficacy outcomes or any of the secondary efficacy outcomes. In both groups, one case of major bleeding was observed., Conclusion: The findings suggest that 3 months of DAPT is not superior to SAPT. A well-powered randomized trial is warranted to assess the efficacy and safety of post-procedural DAPT in chronic limb-threatening ischemia (CLTI) patients undergoing PIP EVT., Clinical Impact: This manuscript reports on the efficacy and safety outcomes of 3 months of DAPT versus SAPT, which are commonly chosen therapies following popliteal and infrapopliteal endovascular therapy. No significant difference was found between the two groups regarding major adverse cardiovascular events, all-cause death, major amputation, or major bleeding. Therefore, 3 months of DAPT does not seem superior to SAPT. These results suggest that SAPT appears to be a sufficient alternative when considering 3 months of DAPT. Further research should verify these outcomes and focus on the efficacy and safety of prolonged DAPT suppletion after endovascular therapy., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Purpose: Peripheral arterial calcification is an important predictor of outcomes after both conservative and endovascular treatment. Digital subtraction angiography (DSA)-based calcification scores are limited by low sensitivity and inter-observer agreement. The Peripheral Arterial Calcium Scoring System (PACSS) assesses the severity of target lesion calcification. The newly introduced modified PACSS (mPACSS) also evaluates target vessel calcification. This study aimed to assess the inter- and intra-observer reliability of PACSS and mPACSS on computed tomography angiography (CTA) in (infra)popliteal endovascular interventions., Methods: A random sample of 50 limbs from the prospective multicenter Dutch Chronic Lower Limb-Threatening Ischemia Registry (THRILLER) were included. Three experienced independent raters scored PACSS on CTA. Three months later, one blinded rater assessed the same 50 CTA scans, keeping track of assessment time. The reliability of the original 5-step PACSS, a simplified binary PACSS (0-2 vs 3-4) and the 7-step mPACSS were tested using Cohen's and Fleiss' kappa statistics., Results: In total, 50 limbs (mean age 70.1 ± 11.0, 29 men) with 41 popliteal and 40 infrapopliteal lesions were scored. Inter-observer agreement of PACSS and binary PACSS were moderate (κ = 0.60) and substantial (κ = 0.72), respectively, while intra-observer agreement was almost perfect in both scores (κ = 0.86). Inter- and intra-observer agreement of mPACSS were moderate (κ = 0.48) and substantial (κ = 0.77), respectively. Mean assessment time for an experienced rater was 3.43 ± 0.93 min per CTA scan., Conclusion: Both the semi-quantitative PACSS and mPACSS scores for (infra)popliteal arteries can be performed reliably on pre-operative CTA., (© 2024. The Author(s).)

Objective: Predicting adverse outcomes in patients with peripheral arterial disease (PAD) is a complex task owing to the heterogeneity in patient and disease characteristics. This systematic review aimed to identify prognostic factors and prognostic models to predict mortality outcomes in patients with PAD Fontaine stage I - III or Rutherford category 0 - 4., Data Sources: PubMed, Embase, and Cochrane Database of Systematic Reviews were searched to identify studies examining individual prognostic factors or studies aiming to develop or validate a prognostic model for mortality outcomes in patients with PAD., Review Methods: Information on study design, patient population, prognostic factors, and prognostic model characteristics was extracted, and risk of bias was evaluated., Results: Sixty nine studies investigated prognostic factors for mortality outcomes in PAD. Over 80 single prognostic factors were identified, with age as a predictor of death in most of the studies. Other common factors included sex, diabetes, and smoking status. Six studies had low risk of bias in all domains, and the remainder had an unclear or high risk of bias in at least one domain. Eight studies developed or validated a prognostic model. All models included age in their primary model, but not sex. All studies had similar discrimination levels of > 70%. Five of the studies on prognostic models had an overall high risk of bias, whereas two studies had an overall unclear risk of bias., Conclusion: This systematic review shows that a large number of prognostic studies have been published, with heterogeneity in patient populations, outcomes, and risk of bias. Factors such as sex, age, diabetes, hypertension, and smoking are significant in predicting mortality risk among patients with PAD Fontaine stage I - III or Rutherford category 0 - 4., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background: Robot-assisted minimally invasive gastrectomy (RAMIG) is increasingly used as a surgical approach for gastric cancer. This study assessed the effectiveness of RAMIG and studied which stages of the IDEAL-framework (1 = Idea, 2A = Development, 2B = Exploration, 3 = Assessment, 4 = Long-term follow-up) were followed., Methods: The Cochrane Library, Embase, Pubmed, and Web of Science were searched for studies on RAMIG up to January 2023. Data collection included the IDEAL-stage, demographics, number of participants, and study design. For randomized controlled trials (RCTs) and long-term studies, data on intra-, postoperative, and oncologic outcomes, survival, and costs of RAMIG were collected and summarized., Results: Of the 114 included studies, none reported the IDEAL-stage. After full-text reading, 18 (16%) studies were considered IDEAL-2A, 75 (66%) IDEAL-2B, 4 (4%) IDEAL-3, and 17 (15%) IDEAL-4. The IDEAL-stages were followed sequentially (2A-4), with IDEAL-2A studies still ongoing. IDEAL-3 RCTs showed lower overall complications (8.5-9.2% RAMIG versus 17.6-19.3% laparoscopic total/subtotal gastrectomy), equal 30-day mortality (0%), and equal length of hospital stay for RAMIG (mean 5.7-8.5 days RAMIG versus 6.4-8.2 days open/laparoscopic total/subtotal gastrectomy). Lymph node yield was similar across techniques, but RAMIG incurred significantly higher costs than laparoscopic total/subtotal gastrectomy ($13,423-15,262 versus $10,165-10,945). IDEAL-4 studies showed similar or improved overall/disease-free survival for RAMIG., Conclusion: During worldwide RAMIG implementation, the IDEAL-framework was followed in sequential order. IDEAL-3 and 4 long-term studies showed that RAMIG is similar or even better to conventional surgery in terms of hospital stay, lymph node yield, and overall/disease-free survival. In addition, RAMIG showed reduced postoperative complication rates, despite higher costs., (© 2024. The Author(s).)

Objective: Lower extremity peripheral arterial disease (PAD) is a severe condition that increases the risk of major adverse cardiovascular events, major adverse limb events, and all cause mortality. This study aimed to investigate the mortality risk among females and males hospitalised for the first time with lower extremity PAD., Methods: Three cohorts of patients who were admitted for the first time with lower extremity PAD in 2007 - 2010, 2011 - 2014, and 2015 - 2018 were constructed. For the 2007 - 2010 and 2011 - 2014 cohorts, the 28 day, one year, and five year mortality rates were calculated, assessing survival time from date of hospital admission until date of death, end of study period, or censoring. For the 2015 - 2018 cohort, only 28 day and one year mortality were investigated due to lack of follow up data. Mortality rates of these cohorts were compared with the general population using standardised mortality rates (SMRs), and the risk of death between sexes was evaluated using Cox proportional hazards models. Cox models were adjusted for age, cardiovascular disease, and diabetes mellitus to account for potential confounding factors., Results: In total, 7 950, 9 670, and 13 522 patients were included in the 2007 - 2010, 2011 - 2014, and 2015 - 2018 cohorts, respectively. Over 60% of individuals in each cohort were males. Mortality rates at 28 day and one year remained stable across all cohorts, while the five year mortality rate increased for both males and females in the 2011 - 2014 cohort. The SMRs both of females and males with PAD were significantly higher than in the general population. Multivariable regression analyses found no significant differences in mortality risk between sexes at 28 day and one year. However, the five year mortality risk was lower in females, with a hazard ratio of 0.89 (95% confidence interval [CI] 0.83 - 0.97) in the 2007 - 2010 cohort and 0.88 (95% CI 0.82 - 0.94) in the 2011 - 2014 cohort., Conclusion: The five year mortality risk has increased, and females face a lower mortality risk than males. Lower extremity PAD still carries unfavourable long term consequences compared with the general population., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Objective: The aim of this study was to update our earlier experience and to evaluate long-term outcomes of chimney endovascular aortic repair performed for selected cases with complex abdominal aortic aneurysm., Methods: A single-center retrospective cohort study was conducted on 51 consecutive patients who underwent chimney endovascular aortic repair procedure, deemed unfit for open surgical repair and fenestrated endovascular aneurysm repair, from October 2009 to November 2019. Kaplan-Meier analyses were used to assess the estimated overall survival, freedom from aneurysm related mortality, freedom from reintervention, freedom from target vessel instability, and freedom from type Ia endoleaks., Results: Fifty-one patients (mean age, 77.1 ± 7.5 years) with a mean preoperative maximum aneurysm diameter of 74.2 ± 20.1 mm were included. Mean follow-up duration was 48.6 months (range, 0-136 months). Estimated overall survival at 5 and 7 years was 36.3% ± 7.1% and 18.3% ± 6.0%, respectively. Freedom from aneurysm-related mortality was 88.6% ± 4.9% at 7 years. Estimated freedom from type Ia endoleaks at 7 years was 91.8% ± 3.9%. A total of 21 late reinterventions were performed in 17 patients (33%). Most of them were performed to treat type II endoleaks with sac growth (47.6%; n = 10) and type Ib endoleak (23.8%; n = 5). Estimated freedom from reintervention at 7 years was 56.3% ± 7.9%. Estimated freedom from target vessel instability at 7 years was 91.5% ± 4.1%., Conclusions: The 7-year results of chimney endovascular aortic repair procedures performed in our center confirm the long-term safety and effectiveness of this technique in a series of high-risk patients with large aneurysms. The present study has, to the best of our knowledge, the longest follow-up for patients treated with chimney endovascular aortic repair, and it provides data to the scarce literature on the long-term outcomes of this procedure, showing acceptable to good long-term results., Competing Interests: Disclosures J.A.v.H. is a consultant for Terumo Aortic, Gore Medical, Cook and Philips Medical systems. C.E.V.B.H. is a consultant for Terumo Aortic, Gore Medical, Cook and Philips Medical systems. S.T. is a consultant and speaker for Medtronic Inc, Gore Medical, and Terumo Aortic., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: Infrapopliteal lesions are generally complex to treat due to small vessel diameter, long lesion length, multilevel disease, and severe calcification. Therefore, different vessel preparation devices have been developed to contribute to better peri- and postprocedural outcomes. This systematic review aims to compare different vessel preparation techniques prior to plain old balloon angioplasty (POBA) or drug-coated balloon (DCB) angioplasty with POBA or DCB alone in infrapopliteal arterial disease., Methods: Medline, EMBASE, and Cochrane databases were searched for studies published between 2000 and 2022 assessing the value of adjunctive vessel preparation in infrapopliteal arterial disease. The primary outcomes were 12-month primary patency and limb salvage., Results: A total of 1685 patients with 1913 lesions were included in 11 POBA studies. Methodological quality was assessed as poor to moderate in these studies. Only 2 studies with 144 patients assessed vessel preparation in conjunction with DCB angioplasty. These randomized trials were assessed as high quality and found no significant benefit of adjunctive atherectomy to DCB angioplasty. The pooled Kaplan-Meier estimates of 12-month primary patency and limb salvage in the POBA studies were 67.8% and 80.9% for POBA, 62.1% and 86.4% for scoring balloons, 67.9% and 79.6% for mechanical atherectomy (MA), and 79.7% and 82.6% for laser atherectomy, respectively. Within the pooled data only scoring balloons and MA demonstrated significantly improved 12-month limb salvage compared to POBA., Conclusions: Different forms of adjunctive vessel preparation demonstrate similar 12-month outcomes compared to POBA and DCB angioplasty alone in infrapopliteal disease, with the exception of improved 12-month limb salvage in scoring balloons and MA. However, since the included studies were heterogeneous and assessed as poor to moderate methodological quality, selection bias may have played an important role. Main conclusion is that this systematic review found no additional value of standard use of vessel preparation., Clinical Impact: Infrapopliteal arterial disease is associated with chronic limb-threatening ischemia (CLTI) and generally complex to treat due to small vessel diameter, long lesion length, multilevel disease and severe calcification. A wide range of vessel preparation devices have been developed to contribute to improved peri- and postprocedural outcomes in these complex lesions. This systematic review aims to compare different vessel preparation techniques prior to plain old balloon angioplasty (POBA) or drug coated balloon (DCB) angioplasty with POBA or DCB angioplasty alone in infrapopliteal arterial disease. Different forms of adjunctive vessel preparation demonstrate similar 12-month outcomes compared to POBA and DCB angioplasty alone in infrapopliteal disease, with the exception of improved 12-month limb salvage in scoring balloons and mechanical atherectomy (MA). However, since the included studies were heterogeneous and assessed as poor to moderate methodological quality, selection bias may have played an important role. Main conclusion is that this systematic review found no additional value of standard use of vessel preparation., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objective: The increasing number of endovascular procedures has resulted in an increasing radiation burden, particularly for the treatment team. Fiber Optic RealShape (FORS) technology uses laser light instead of fluoroscopy to visualise the endovascular guidewire and catheters. These devices can be used during the navigational part of procedures, such as cannulation of the contralateral limb (CL) in endovascular aneurysm repair (EVAR). The aim of this study was to describe the effect of using FORS on radiation dose during CL cannulation in standard EVAR., Methods: This was a non-randomised, retrospective comparison study of prospectively collected, single centre data from FORS guided EVAR compared with a conventional fluoroscopy only guided EVAR cohort. A total of 27 FORS guided cases were matched 1:1 based on sex, age, and body mass index (BMI) with 27 regular (fluoroscopy only) EVARs. This study primarily focused on (1) technical success of FORS and (2) navigation time and radiation dose (cumulative air kerma [CAK], air kerma area product [KAP], and fluoroscopy time [FT]) during cannulation of the CL. In addition, overall procedure time and radiation dose of the complete EVAR procedure were studied., Results: In 22 (81%) of the 27 FORS guided cases the CL was successfully cannulated using FORS. All radiation dose parameters were significantly lower in the FORS group (CAK, p < .001; KAP, p = .009; and FT, p < .001) for an equal navigation time (p = .95). No significant differences were found when comparing outcomes of the complete procedure., Conclusion: Use of FORS technology significantly reduces radiation doses during cannulation of the CL in standard EVAR., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Introduction: The aim of this study is to share preliminary experiences and outcomes with a novel custom-made fenestrated TREO ® Abdominal Stent-Graft System to treat juxtarenal and pararenal abdominal aortic aneurysms (AAAs)., Methods: Juxtarenal and pararenal AAA patients treated with the custom-made fenestrated TREO ® Abdominal Stent-Graft System were included from 4 high-volume European academic medical centers from June 2021 to September 2023. Technical success and 30-day/in-hospital mortality and complications were analyzed. Technical success was defined as successful endovascular implantation of the stent graft with preservation of antegrade flow to the target vessels, and absence of type 1 or 2 endoleak (EL) at the first postoperative computed tomography angiography (CTA)., Results: Forty-two consecutive patients were included. The majority of the devices were constructed with 2 (N=4; 9.5%), 3 (N=9; 21.4%), or 4 (N=27; 64%) fenestrations. In 1 case, the device was constructed with a single fenestration (2.4%) and 1 device contained 5 fenestrations (2.4%); 17% had previous AAA repair. Target vessel cannulation with placement of a bridging stent was successful in all but 1 vessel (99, 3%). One aneurysm-related death occurred in the direct postoperative period and 2 limb occlusions necessitated reintervention during admission. In the median follow-up period of 101 (2-620) days, 3 more patients died due to non-aneurysm-related causes. Technical success was achieved in 90% of the cases. Nineteen ELs were seen on the first postoperative CT scan: 1 type 1b EL (N=1; 2%), 15 type 2 ELs (N=15; 36%), and 3 type 3 ELs (N=3%). Eleven patients received more than 1 CT scan during a median follow-up of 361 days (82-620): 3 type 2 ELs resolved and 1 type 3 EL was treated in this period. In the follow-up, 1 patient had a coagulation disorder that caused occlusions of the branches., Conclusion: The results of the first experiences using the custom-made fenestrated TREO® Abdominal Stent-Graft System in Europe are promising. There was a low short-term mortality and morbidity rate in these patients of which 17% had previous AAA repair. Mid-term and long-term follow-up data are needed to evaluate endograft durability and performance., Clinical Impact: This study shows the first experiences and short-term results of a novel low-profile custom-made device: the custom-made fenestrated TREO ® Abdominal Stent-Graft System. Showing these results and experiences can help the physicians in clinical decision-making for their patients., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared that KK Yeung, V Riambau, AWJ Hoksbergen, JA van Herwaarden, CEVB Hazenberg and G Pratesi are performing consultancy work for Terumo Aortic.

Purpose: Vessel calcification is estimated to be present in 30% to 50% of patients with peripheral arterial disease (PAD) and is one of the main challenges in endovascular treatment. The popliteal artery is unique compared with other arteries due to its exposure to significant deformation and biomechanical stress during knee motion. Intravascular lithotripsy (IVL) is a novel technique that uses acoustic pressure waves to cause microfractures within the intimal and medial wall calcification. Intravascular lithotripsy is safe in femoropopliteal and infrapopliteal lesions, but follow-up studies are lacking. Therefore, the purpose of this study was to describe the first follow-up outcomes of IVL in popliteal and infrapopliteal arterial disease., Methods: This prospective, multicenter cohort study included all patients treated with IVL in the popliteal and infrapopliteal arteries at 4 sites. Standardized follow-up with duplex ultrasonography was scheduled at 6 to 8 weeks and 12 months. The primary safety endpoint was a composite of major adverse events (MAEs) at 30 days. Primary efficacy endpoints were primary patency, limb salvage, and amputation-free survival (AFS) at 12 months. Secondary endpoints were primary-assisted patency and freedom from target lesion revascularization (TLR). Endpoints were distributed for patients with chronic limb-threatening ischemia (CLTI) and intermittent claudication (IC) and estimated using the Kaplan-Meier method., Results: Between April 2021 and March 2023, 29 patients with 30 limbs were treated. Diabetes mellitus (DM) and CLTI were present in 62.1% and 80.0% of patients, respectively. Within the 32 treated lesions, severe calcification was present in 84.4% and bailout stenting was necessary in 12.5% of the lesions. Four MAEs occurred within 30 days: 1 closure device failure, 1 major amputation, and 2 deaths, neither of which was related to the study device. The primary patency, primary-assisted patency, freedom from TLR, limb salvage, and AFS at 12 months were 68.8%, 90.0%, 93.3%, 83.9%, and 57.1% for CLTI patients, respectively. No events occurred in restenosis, re-occlusion, TLR, major amputation, or mortality in patients with IC., Conclusions: This first-ever analysis on follow-up outcomes of IVL in the popliteal and infrapopliteal arteries demonstrated promising safety and efficacy outcomes with a low rate of bailout stenting., Clinical Impact: Vessel calcification is a common feature in peripheral arterial disease (PAD) and is one of the main challenges in endovascular treatment. The popliteal artery is subjected to biomechanical stress during knee motion, which makes stenting unappealing and often leads to worse clinical outcomes. This study aimed to describe the first follow-up outcomes of IVL in popliteal and infrapopliteal arterial disease. As in line with previous studies, no relevant procedural complications were found and the rate of bail-out stenting was only 12.5%. Moreover, in a complex patient population, this study demonstrated promising safety and efficacy outcomes. The comparison of IVL with angioplasty alone or other vessel preparation devices for popliteal and infrapopliteal arterial disease is warranted., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Introduction: Chronic limb-threatening ischemia (CLTI) is the end stage of peripheral arterial disease (PAD) and is associated with high amputation rates, mortality and disease-related health care costs. In infrapopliteal arterial disease (IPAD), endovascular revascularization should be considered for the majority of anatomical and clinical subgroups of CLTI. However, a gap of high-quality evidence exists in this field. The aim of the Dutch Chronic Lower Limb-Threatening Ischemia Registry (THRILLER) is to collect real world data on popliteal and infrapopliteal endovascular interventions., Methods: THRILLER is a clinician-driven, prospective, multicenter, observational registry including all consecutive patients that undergo a popliteal or infrapopliteal endovascular intervention in seven Dutch hospitals. We estimate that THRILLER will include 400-500 interventions annually. Standardized follow-up visits with wound monitoring, toe pressure measurement and duplex ultrasonography will be scheduled at 6-8 weeks and 12 months after the intervention. The independent primary endpoints are primary patency, limb salvage and amputation free survival. Patients must give informed consent before participation and will be included according to predefined reporting standards. A data log of patients who meet the inclusion criteria but are not included in the registry will be maintained. We intend to conduct the first interim analysis two years after the start of inclusion. The results will be published in a scientific journal., Discussion: Despite innovations in medical therapy and revascularization techniques, patients with CLTI undergoing endovascular revascularization still have a moderate prognosis. Previous prospective cohort studies were hampered by small sample sizes or heterogeneous reporting. Randomized controlled trials (RCTs) have high costs, potential conflicts of interest and give a limited reflection of daily practice. THRILLER aims to provide the largest prospective well phenotyped up-to-date dataset on treatment outcomes in CLTI patients to answer multiple underexplored research questions regarding diagnostics, medication, patient selection, treatment strategies and post intervention follow-up., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Nugteren et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Vascular surgeons and interventional radiologists face chronic exposure to low-dose radiation during endovascular procedures, which may impact their health in the long term due to their stochastic effects. The presented case shows the feasibility and efficacy of combining Fiber Optic RealShape (FORS) technology and intravascular ultrasound (IVUS) to reduce operator exposure during the endovascular treatment of obstructive peripheral arterial disease (PAD). FORS technology enables real-time, three-dimensional visualization of the full shape of guidewires and catheters, embedded with optical fibers that use laser light instead of fluoroscopy. Hereby, radiation exposure is reduced, and spatial perception is improved while navigating during endovascular procedures. IVUS has the capacity to optimally define vessel dimensions. Combining FORS and IVUS in a patient with iliac in-stent restenosis, as shown in this case report, enables passage of the stenosis and pre- and post-percutaneous transluminal angioplasty (PTA) plaque assessment (diameter improvement and morphology), with a minimum dose of radiation and zero contrast agent. The aim of this article is to describe the method of combining FORS and IVUS stepwise, to show the potential of merging both techniques in view of reducing radiation exposure and improving navigation tasks and treatment success during the endovascular procedure for the treatment of PAD.

Objective: Plasma extracellular vesicles (EV) are an emerging source of biomarkers for diagnosis and prognosis of cardiovascular disease (CVD). Risk stratification for common adverse events such as major adverse limb events (MALE) and major adverse cardiovascular events (MACE) by an EV blood sample could improve healthcare management by individualising drug therapy or improving informed decision making regarding revascularisations in patients with peripheral artery disease (PAD). As such, this study investigated the associations between plasma EV proteins and prospectively registered MALE and MACE in consecutive patients undergoing femoral endarterectomy., Methods: Using the Athero-Express biobank study, four EV proteins (Cystatin C, CD14, Serpin C1, and Serpin G1) were measured in the high density lipoprotein subfraction isolated from plasma of 317 PAD patients undergoing arterial revascularisation. Multivariable Cox proportional hazard regression was used to investigate the association between plasma EV protein levels and MACE and MALE in the three year post-operative period., Results: Most patients were treated for claudication (Fontaine II, 52.8%), although rest pain (Fontaine III, 30.1%) and ischaemic wounds (Fontaine IV, 17.1%) were common in this cohort. Within three years 51 patients died, amongst whom 25 deaths were due to CVD, 39 patients experienced a MACE, and 125 patients experienced a MALE. Multivariable regression models, based on statistically proven covariables and literature, showed a significant association of Serpin G1 (HR 1.49; 95% CI 1.08 - 2.06; p = .016) and CD14 (HR 1.40; 1.03 - 1.90; p = .029) with MACE, and of Serpin G1 (HR 1.29; 1.07 - 1.57; p = .009) with MALE., Conclusion: Serpin G1 and CD14 plasma EV protein levels are associated with future MACE and MALE in patients with severe PAD., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Objective: Pseudoxanthoma elasticum (PXE) is an autosomal recessive metabolic disorder that may be associated with a high prevalence of peripheral artery disease (PAD) and related symptoms. However, the evidence supporting this association is weak, as only small cohort studies are available. Furthermore, limited data are available on the outcome of lower limb peripheral arterial interventions (PAI) in patients with PXE. It was the aim of this study to clarify the prevalence of PAD, and the occurrence and outcome of PAI in patients with PXE., Methods: This was a retrospective review of prospectively collected data from the Dutch Expertise Centre for PXE database. Clinical data of consecutive patients with a definitive diagnosis of PXE were examined. The primary endpoint was the prevalence of PAD (defined as an ankle brachial index of < 0.9). The secondary endpoint was to report an overview of PAI and target lesion revascularisations., Results: In 285 PXE patients (median age 58 years), 50.9% of patients (n = 145) met the criteria for PAD. Seventeen patients underwent a PAI, mostly for intermittent claudication, at a median age of 51 years. The incidence of PAI was 2.25 per 1 000 patient years in patients with PAD and PXE. A total of 58 interventions was recorded, of which 35 were target lesion revascularisations in nine patients. Twenty one revascularisations were performed within a year following the primary intervention, in 16 cases due to an acute occlusion., Conclusion: Within a well phenotyped and large PXE cohort, the diagnosis of PAD was prevalent in one in two patients. The observed rate of peripheral interventions was low, while the re-intervention rate was unfavourable after endovascular or bypass surgical procedures, with over half of these re-interventions indicated within a year., (Copyright © 2022. Published by Elsevier B.V.)

Background: Tortuous arteries may be associated with carotid dissection. The intima disruption caused by a carotid dissection is a possible cause of extracranial carotid artery aneurysms (ECAAs). The aim was to investigate if carotid tortuosity is also associated with ECAA in patients without presence or history of a carotid artery dissection., Methods: A retrospective case-control study was performed including 35 unilateral ECAA patients (cases) and 105 age- and sex-matched controls. Tortuosity was expressed as tortuosity-index (TI), curvature, and torsion measured on computed tomography angiography (CTA) data in 3Mensio Vascular and MATLAB by two independent investigators. Primary comparison was tortuosity in ipsi- versus contralateral carotid artery within the cohort of ECAA patients. Secondary comparison was tortuosity with ipsilateral carotid arteries in control patients. All observations were assessed on inter- and intra-operator reproducibility., Results: Carotid tortuosity was comparable within the cohort of ECAA patients (Spearman correlation 0.76, P<0.001), yet distinctively higher in comparison with unilateral controls. After adjustment for patient characteristics, presence of ECAA was associated with TI (β 0.146, 95% CI: 0.100-0.192). All tortuosity observations showed excellent inter- and intra-operator reproducibility., Conclusions: Carotid tortuosity seems to be a risk factor for development of ECAA. Surveillance of individuals with increased carotid tortuosity therefore potentially ensures prompt diagnosis and treatment of ECAA. However, future research should investigate if persons with an increased tortuosity do indeed develop ECAA., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://qims.amegroups.com/article/view/10.21037/qims-22-89/coif). The authors have no conflicts of interest to declare., (2022 Quantitative Imaging in Medicine and Surgery. All rights reserved.)

Background: A chronic exposure to low dose radiation, as encountered in endovascular procedures, may impact the health of surgeons and radiologists over a timespan of several months to a lifetime. This study evaluates the feasibility and efficacy of a radiation absorbing sterile drape (RADPAD) to reduce operator exposure during the endovascular treatment of obstructive peripheral artery disease (PAD)., Methods: Between February 2016 and September 2017, patients with PAD who received percutaneous transluminal angioplasty, stent placement, remote endarterectomy, or a combination thereof were included in this nonrandomized study. Patients were equally divided over a study cohort (with RADPAD) and a control cohort (without RADPAD). The unshielded body dose (E) of the staff was measured via electronic dosimeters placed at a chest height of the first operator (FO), second operator (SO), and sterile nurse (SN). A virtual maximum operator (MO) dose was constructed, yielding the highest dose per fluoroscopy run for either of the operators. Simultaneously, the dose area product (DAP) and C-arm settings for each fluoroscopy run were extracted. Staff exposures of the study cohort and control cohort were compared in terms of relative exposure (E/DAP). A secondary analysis involved an analysis of the individual fluoroscopy runs using a multivariate generalized linear mixed effect model., Results: In total, 49 patients were included in this study. The use of RADPAD was technically feasible. Significant reductions of relative exposure were observed when comparing the study cohort with the control cohort. The relative exposure of the FO was reduced with 66.5% (1.82 vs. 0.61 μSv/Gycm 2 , P < 0.001), the relative exposure of the SO with 68.3% (0.55 vs. 0.17 μSv/Gycm 2 , P = 0.02), and the relative exposure of the MO with 65.8% (2.06 vs. 0.71 μSv/Gycm 2 , P < 0.001). Dose levels of SN were too low to draw conclusions under the current sample size. The multivariate generalized linear mixed effect model showed a significant correlation between absolute exposure of the MO and the use of the RADPAD (odds: 0.51, P < 0.001)., Conclusions: Usage of a radiation absorbing drape (RADPAD) during endovascular treatment of PAD results in statistically significant reduction in a relative operator dose while presenting no drawbacks. The use of these drapes is advised in future peripheral endovascular procedures., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: Report of a successful case of endovascular recanalization of an occluded superficial femoral artery (SFA) using Fiber Optic RealShape (FORS) technology., Case Report: A 79-year-old male was referred for evaluation of multiple ischemic pretibial ulcers of the right lower extremity. Computed tomography-angiography (CTA) imaging confirmed significant stenosis of the right common femoral artery (CFA) and an occlusion of the SFA from its origin to the Hunter's canal. The patient was treated with a hybrid surgical procedure: an endarterectomy of the CFA and SFA origin was performed combined with an endovascular recanalization of the occluded SFA using FORS technology. During recanalization, the FORS guidewire slowly twisted subintimally around the occluded lumen of the SFA, maintaining the created corkscrew shape after pre-dilation with the percutaneous transluminal angioplasty (PTA) balloon and subsequent stenting., Conclusions: FORS technology can be successfully used during recanalization of an occluded SFA without the use of fluoroscopy. The corkscrew shape formed during recanalization in this case was retained during PTA balloon pre-dilation and stenting; this potentially improves hemodynamics and thereby reduces the risk of in-stent restenosis. However, expanding patient series and longer follow-up data are needed to increase the understanding of the feasibility and effectiveness of using FORS in the treatment of peripheral arterial occlusive disease.

Introduction: The evolution of endovascular surgery over the past 30 years has made it possible to treat increasingly complex vascular pathologies with an endovascular method. Although this generally speeds up the patient's recovery, the risks of health problems caused by long-term exposure to radioactive radiation increase. This warrants the demand for radiation-reducing tools to reduce radiation exposure during these procedures., Areas Covered: For this systematic review Pubmed, Embase and Cochrane library databases were searched on 28 December 2021 to provide an overview of tools that are currently used or have the potential to contribute to reducing radiation exposure during endovascular aortic procedures. In addition, an overview is presented of radiation characteristics of clinical studies comparing a (potential) radiation-reducing device with conventional fluoroscopy use., Expert Opinion: Radiation-reducing instruments such as fiber optic shape sensing or electromagnetic tracking devices offer the possibility to further reduce or even eliminate the use of radiation during endovascular procedures. In an era of increasing endovascular interventional complexity and awareness of the health risks of long-term radiation exposure, the use of these technologies could have a major impact on an ongoing challenge to move toward radiation-free endovascular surgery.

Purpose: Treatment of blunt thoracic aortic injuries (BTAIs) has shifted from the open surgical approach to the use of thoracic endovascular aortic repair (TEVAR), of which early outcomes appear promising but controversy regarding long-term outcomes remains. The goal of this study was to determine the long-term TEVAR outcomes for BTAI, particularly radiographic outcomes, complications and health-related quality of life (HRQoL)., Methods: Retrospectively, all patients with BTAIs presented at a single level 1 trauma center between January 2008 and December 2018 were included. Radiographic and clinical outcomes were determined (early and long term). In addition, HRQoL scores using EuroQOL-5-Dimensions-3-Level (EQ-5D-3L) and Visual Analog Scale (EQ-VAS) questionnaires were assessed, and compared to an age-adjusted reference and trauma population., Results: Thirty-one BTAI patients met the inclusion criteria. Of these, 19/31 received TEVAR of which three died in hospital due to aorta-unrelated causes. In total, 10/31 patients died due to severe (associated) injuries before TEVAR could be attempted. The remaining 2/31 had BTAIs that did not require TEVAR. Stent graft implantation was successful in all 19 patients (100%). At a median radiographic follow-up of 3 years, no stent graft-related problems (endoleaks/fractures) were observed. However, one patient experienced acute stent graft occlusion approximately 2 years after TEVAR, successfully treated with open repair. Twelve patients required complete stent graft coverage of the left subclavian artery (LSCA) (63%), which did not result in ischemic complaints or re-interventions. Of fourteen surviving TEVAR patients, ten were available for questionnaire follow-up (follow-up rate 71%). At a median follow-up of 5.7 years, significant HRQoL impairment was found (p < 0.01)., Conclusion: This study shows good long(er)-term radiographic outcomes of TEVAR for BTAIs. LSCA coverage did not result in complications. Patients experienced HRQoL impairment and were unable to return to an age-adjusted level of daily-life functioning, presumably due to concomitant orthopedic and neurological injuries., (© 2020. The Author(s).)

Introduction: Peripheral arterial disease (PAD) is an atherosclerotic disease leading to stenosis and/or occlusion of the arterial circulation of the lower extremities. The currently available revascularisation methods have an acceptable initial success rate, but the long-term patency is limited, while surgical revascularisation is associated with a relatively high perioperative risk. This urges the need for development of less invasive and more effective treatment modalities. This protocol article describes a study investigating a new non-invasive technique that uses robot assisted high-intensity focused ultrasound (HIFU) to treat atherosclerosis in the femoral artery., Methods and Analysis: A pilot study is currently performed in 15 symptomatic patients with PAD with a significant stenosis in the common femoral and/or proximal superficial femoral artery. All patients will be treated with the dual-mode ultrasound array system to deliver imaging-guided HIFU to the atherosclerotic plaque. Safety and feasibility are the primary objectives assessed by the technical feasibility of this therapy and the 30-day major complication rate as primary endpoints. Secondary endpoints are angiographic and clinical success and quality of life., Ethics and Dissemination: Ethical approval for this study was obtained in 2019 from the Medical Ethics Committee of the University Medical Center Utrecht, the Netherlands. Data will be presented at national and international conferences and published in a peer-reviewed journal., Trial Registration Number: NL7564., Competing Interests: Competing interests: CEVBH reports grants from International Cardio Corporation during the conduct of the study. He is a consultant for Cook Medical, Gore Medical, and Terumo Aortic. PD is one of the founders of the International Cardio Corporation; EE reports grants, personal fees and non-financial support from International Cardio Corporation, during the conduct of the study; grants and personal fees from International Cardio Corporation, grants and personal fees from National Institutes of Health, outside the submitted work; In addition, EE has a patent Dual mode ultrasound transducer (DMUT) system and method for controlling delivery of ultrasound therapy with royalties paid to International Cardio Corporation, a patent Vascular characterisation using ultrasound imaging with royalties paid to International Cardio, and a patent ultrasound image formation and/or reconstruction using multiple frequency waveforms with royalties paid to International Cardio Corporation., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Backgrounds and Aims: Elevated lipoprotein(a) (Lp[a]) has been identified as a causal risk factor for cardiovascular disease including peripheral arterial disease (PAD). Although Lp(a) is associated with the diagnosis of PAD, it remains elusive whether there is an association of Lp(a) with cardiovascular and limb events in patients with severe PAD., Methods: Preoperative plasma Lp(a) levels were measured in 384 consecutive patients that underwent iliofemoral endarterectomy and were included in the Athero-Express biobank. Our primary objective was to assess the association of Lp(a) levels with Major Adverse Limb Events (MALE). Our secondary objective was to relate Lp(a) levels to Major Adverse Cardiovascular Events (MACE) and femoral plaque composition that was acquired from baseline surgery., Results: During a median follow-up time of 5.6 years, a total of 225 MALE were recorded in 132 patients. Multivariable analysis, including history of peripheral intervention, age, diabetes mellitus, end stage renal disease and PAD disease stages, showed that Lp(a) was independently associated with first (HR of 1.36 (95% CI 1.02-1.82) p = .036) and recurrent MALE (HR 1.36 (95% CI 1.10-1.67) p = .004). A total of 99 MACE were recorded but Lp(a) levels were not associated with MACE.sLp(a) levels were significantly associated with a higher presence of smooth muscle cells in the femoral plaque, although this was not associated with MALE or MACE., Conclusions: Plasma Lp(a) is independently associated with first and consecutive MALE after iliofemoral endarterectomy. Hence, in patients who undergo iliofemoral endarterectomy, Lp(a) could be considered as a biomarker to enhance risk stratification for future MALE., (Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.)

Objectives: The ankle brachial index (ABI) can be used to diagnose peripheral arterial disease (PAD). The clinical relevance of the ABI, especially in patients with known clinically manifest cardiovascular disease (CVD), is unknown. The authors set out to investigate the relationship between a screen-detected ABI and the risk for future cardiovascular morbidity and mortality in patients with clinically manifest CVD., Design, Materials and Methods: Patients with clinically manifest CVD were selected from the UCC-SMART cohort (n = 8360) and divided into four groups: normal ABI (0.91-1.39), screen-detected low ABI ≤ 0.9, screen-detected high ABI ≥ 1.4, and patients with known PAD irrespective of their ABI. Adjusted Cox Proportional Hazard Ratios (HRs) for Major Adverse Cardiovascular Events (MACE), Major Adverse Limb Events (MALE), and all-cause mortality were calculated. In addition, stratified analyses for women and men and for the presence of diabetes were performed., Results: During a median follow-up of 8.3 years (IQR 7.7) 1646 MACE, 601 MALE and 1958 all-cause mortalities were observed. Compared with normal ABI patients, patients with a screen-detected low ABI and patients with manifest PAD had a higher risk of MACE, MALE, and all-cause mortality with HRs of 1.9 (95% CI 1.6-2.2) for MACE, 7.6 (95% CI 5.7-10.1) for MALE, 1.7 (95% CI 1.5-2.0) for mortality and 1.3 (95% CI 1.2-1.5) for MACE, 13.8 (95% CI 11.1-17.1) for MALE, 1.7 (95% CI 1.5-1.9) for mortality, respectively. Screen-detected high ABI did not increase the risk of either MACE or MALE, however, was associated with lower risk of all-cause mortality with a HR of 0.6 (95% CI 0.5-0.9). Stratified analyses for women & men and for diabetes status were comparable for all three outcomes., Conclusions: In patients with manifest CVD but without PAD, a screen-detected low ABI is a powerful risk indicator for cardiovascular events, limb events, and all-cause mortality., Competing Interests: The authors have declared that no competing interests exist.

Background: To provide an overview of the literature on the mid-term outcomes of chimney EVAR (ChEVAR) for the treatment of juxtarenal abdominal aortic aneurysms (JAAA)., Methods: Different electronic databases were searched for published articles up to January 2020. The eligibility criteria were studies describing mid- or long-term outcomes of chimney EVAR (mean follow-up at least 1 year) for treatment of JAAA, including more than 10 cases, published in English, and with full text available. The outcomes measure were overall survival rate, target vessel patency, and freedom from reintervention at 3 years. Quality of the included studies was analyzed using the MINORS criteria. Pooled effect estimates were analyzed using random-effect models and heterogeneity was tested using I 2 statistics., Results: Thirteen articles met the inclusion criteria. The included studies described 1,019 patients. According to the quality assessment, methodological quality was moderate to poor. The pooled overall survival, freedom from reintervention, and target vessel patency at 3 year was 81.4 % (95%CI 73.8-87.9), 85.7% (95%CI 75.6-93.5), and 95.1% (95%CI 89.3-98.7) respectively., Conclusions: The results of this review show good to acceptable short and mid-term survival and good mid-term durability, which supports that ChEVAR as a suitable alternative in high-risk JAAA. However, proper patient selection for ChEVAR seems essential to attain good mid-term outcomes, and further large prospective and good quality studies are required to demonstrate its long-term results and enable conclusions on specific determinants for outcome., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: We evaluate nationwide perioperative outcomes of complex EVAR and assess the volume-outcome association of complex EVAR., Summary of Background Data: Endovascular treatment with fenestrated (FEVAR) or branched (BEVAR) endografts is progressively used for excluding complex aortic aneurysms (complex AAs). It is unclear if a volume-outcome association exists in endovascular treatment of complex AAs (complex EVAR)., Methods: All patients prospectively registered in the Dutch Surgical Aneurysm Audit who underwent complex EVAR (FEVAR or BEVAR) between January 2016 and January 2020 were included. The effect of annual hospital volume on perioperative mortality was examined using multivariable logistic regression analyses. Patients were stratified into quartiles based on annual hospital volume to determine hospital volume categories., Results: We included 694 patients (539 FEVAR patients, 155 BEVAR patients). Perioperative mortality following FEVAR was 4.5% and 5.2% following BEVAR. Postoperative complication rates were 30.1% and 48.7%, respectively. The first quartile hospitals performed <9 procedures/yr; second, third, and fourth quartile hospitals performed 9-12, 13-22, and ≥23 procedures/yr. The highest volume hospitals treated the significantly more complex patients. Perioperative mortality of complex EVAR was 9.1% in hospitals with a volume of < 9, and 2.5% in hospitals with a volume of ≥13 (P = 0.008). After adjustment for confounders, an annual volume of ≥13 was associated with less perioperative mortality compared to hospitals with a volume of < 9., Conclusions: Data from this nationwide mandatory quality registry shows a significant effect of hospital volume on perioperative mortality following complex EVAR, with high volume complex EVAR centers demonstrating lower mortality rates., Competing Interests: Disclosures: Conflicts of interest: JW: Consultant for Cordis/Cardinal Health, former consultant for Baxter; JvH: Consultant/ proctor for Terumo Aortic, Cook, Microport, WL Gore and Philips; BM: Consultant for Philips; CZ: Consultant for Terumo Aortic; GS: Consultant for Cook and Philips; HV: Consultant for Medtronic, WL Gore, Terumo, Endologix, and Philips The authors report no conflicts of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: This retrospective study quantifies target vessel displacement during fenestrated and branched endovascular aneurysm repair due to the introduction of stiff guidewires and stent graft delivery systems. The effect that intraoperative vessel displacement has on the usability of computed tomography angiography (CTA) roadmaps is also addressed., Methods: Patients that underwent fenestrated or branched EVAR were included in this retrospective study. Two imaging datasets were collected from each patient: (I) preoperative CTA and (II) intraoperative contrast-enhanced cone beam computed tomography (ceCBCT) acquired after the insertion of the stiff guidewire and stent graft delivery system. After image registration, the 3D coordinates of the ostium of the celiac artery, superior mesenteric artery, right renal artery and left renal artery were recorded in both the CTA and the ceCBCT dataset by two observers. The three-dimensional displacement of the ostia of the target vessels was calculated by subtracting the coordinates of CTA and ceCBCT from one another. Additionally, the tortuosity index and the maximum angulation of the aorta were calculated., Results: In total 20 patients and 77 target vessels were included in this study. The ostium of the celiac, superior mesenteric, right renal and left renal artery underwent non-uniform three-dimensional displacement with mean absolute displacement of 8.2, 7.7, 8.2 and 6.2 mm, respectively. The average displacement of all different target vessels together was 7.8 mm. A moderate correlation between vessel displacement and the maximum angulation of the aortoiliac segment was found (Spearman's ρ=0.45, P<0.05)., Conclusions: The introduction of stiff endovascular devices during fenestrated or branched EVAR causes significant, non-uniform displacement of the ostium of the visceral and renal target vessels. Consequently, preoperative CTA roadmaps based on bone registration are suboptimal to guide target vessel catheterization during these procedures., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/qims-20-1077). JAvH and CEVBH have been consultants for Cook Medical, Gore Medical, Medtronic and Terumo Aortic, and have a research and consultancy agreement with Philips Medical. The other authors have no conflicts of interest to declare., (2021 Quantitative Imaging in Medicine and Surgery. All rights reserved.)

Introduction: While the operator radiation dose rates are correlated to patient radiation dose rates, discrepancies may exist in the effect size of each individual radiation dose predictors. An operator dose rate prediction model was developed, compared with the patient dose rate prediction model, and converted to an instant operator risk chart., Materials and Methods: The radiation dose rates (DR operator for the operator and DR patient for the patient) from 12,865 abdomen X-ray acquisitions were selected from 50 unique patients undergoing standard or complex endovascular aortic repair (EVAR) in the hybrid operating room with a fixed C-arm. The radiation dose rates were analyzed using a log-linear multivariable mixed model (with the patient as the random effect) and incorporated varying (patient and C-arm) radiation dose predictors combined with the vascular access site. The operator dose rate models were used to predict the expected radiation exposure duration until an operator may be at risk to reach the 20 mSv year dose limit. The dose rate prediction models were translated into an instant operator radiation risk chart., Results: In the multivariate patient and operator fluoroscopy dose rate models, lower DR operator than DR patient effect size was found for radiation protocol (2.06 for patient vs 1.4 for operator changing from low to medium protocol) and C-arm angulation. Comparable effect sizes for both DR operator and DR patient were found for body mass index (1.25 for patient and 1.27 for the operator) and irradiated field. A higher effect size for the DR operator than DR patient was found for C-arm rotation (1.24 for the patient vs 1.69 for the operator) and exchanging from femoral access site to brachial access (1.05 for patient vs 2.5 for the operator). Operators may reach their yearly 20 mSv year dose limit after 941 minutes from the femoral access vs 358 minutes of digital subtraction angiography radiation from the brachial access., Conclusion: The operator dose rates were correlated to patient dose rate; however, C-arm angulation and changing from femoral to brachial vascular access site may disproportionally increase the operator radiation risk compared with the patient radiation risk. An instant risk chart may improve operator dose awareness during EVAR.

Objective: Endovascular procedures are conventionally conducted using two dimensional fluoroscopy. A new technology platform, Fiber Optic RealShape (FORS), has recently been introduced allowing real time, three dimensional visualisation of endovascular devices using fiberoptic technology. It functions as an add on to conventional fluoroscopy and may facilitate endovascular procedures. This first in human study assessed the feasibility of FORS in clinical practice., Methods: A prospective cohort feasibility study was performed between July and December 2018. Patients undergoing (regular or complex) endovascular aortic repair (EVAR) or endovascular peripheral lesion repair (EVPLR) were recruited. FORS guidance was used exclusively during navigational tasks such as target vessel catheterisation or crossing of stenotic lesions. Three types of FORS enabled devices were available: a flexible guidewire, a Cobra-2 catheter, and a Berenstein catheter. Devices were chosen at the physician's discretion and could comprise any combination of FORS and non-FORS devices. The primary study endpoint was technical success of the navigational tasks using FORS enabled devices. Secondary study endpoints were user experience and fluoroscopy time., Results: The study enrolled 22 patients: 14 EVAR and eight EVPLR patients. Owing to a technical issue during start up, the FORS system could not be used in one EVAR. The remaining 21 procedures proceeded without device or technology related complications and involved 66 navigational tasks. In 60 tasks (90.9%), technical success was achieved using at least one FORS enabled device. Users rated FORS based image guidance "better than standard guidance" in 16 of 21 and "equal to standard guidance" in five of 21 procedures. Fluoroscopy time ranged from 0.0 to 52.2 min. Several tasks were completed without or with only minimal X-ray use., Conclusion: Real time navigation using FORS technology is safe and feasible in abdominal and peripheral endovascular procedures. FORS has the potential to improve intra-operative image guidance. Comparative studies are needed to assess these benefits and potential radiation reduction., (Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.)

Objective: To describe the feasibility of a fresh frozen human cadaver model for research and training of endovascular image guided procedures in the aorta and lower extremity., Methods: The cadaver model was constructed in fresh frozen human cadaver torsos and lower extremities. Endovascular access was acquired by inserting a sheath in the femoral artery. The arterial segment of the specimen was restricted by ligation of collateral arteries and, in the torsos, clamping of the contralateral femoral artery and balloon occlusion of the supratruncal aorta. Tap water was administered through the sheath to create sufficient intraluminal pressure to manipulate devices and acquire digital subtraction angiography (DSA). Endovascular cannulation tasks of the visceral arteries (torso) or the peripheral arteries (lower extremities) were performed to assess the vascular patency of the model. Feasibility of this model is based on our institute's experiences throughout the use of six fresh frozen human cadaver torsos and 22 lower extremities., Results: Endovascular simulation in the aortic and peripheral vasculature was achieved using this human cadaver model. Acquisition of DSA images was feasible in both the torsos and the lower extremities. Approximately 84 of the 90 target vessels (93.3%) were patent, the remaining six vessels showed signs of calcified steno-occlusive disease., Conclusions: Fresh frozen human cadavers provide a feasible simulation model for aortic and peripheral endovascular interventions, and can potentially reduce the need for animal experimentation. This model is suitable for the evaluation of new endovascular devices and techniques or to master endovascular skills., Competing Interests: The authors have declared that no competing interests exist.

Purpose: To report an experience with the Absorb bioresorbable vascular scaffold (BVS) in an Asian cohort with chronic limb-threatening ischemia (CLTI) from the DISAPEAR ( D rug I mpregnated Bioresorbable S tent in A sian P opulation E xtremity A rterial R evascularization) registry. Materials and Methods: A retrospective analysis was conducted of 41 patients (median age 64 years; 23 men) with CLTI owing to >50% de novo infrapopliteal lesions (n=53) treated with the Absorb BVS between August 2012 and June 2017. The majority of patients (37, 90%) had diabetes, 24 (59%) had ischemic heart disease, and 39 (95%) had Rutherford category 5/6 ischemia with tissue loss. The mean lesion length was 22.7±17.2 mm; 10 (24%) lesions were severely calcified. Assessments included technical success, primary patency, freedom from clinically-driven target lesion revascularization (CD-TLR), amputation-free survival, limb salvage, complete wound healing, resolution of rest pain, and resolution of CLTI without TLR at 6 and 12 months after the index intervention. Results: Overall, 69 scaffolds were implanted in the 53 lesions, with 100% technical success. There were no deaths within 30 days of the index procedure. The primary patency rates at 6 and 12 months were 95% and 86%, respectively. The corresponding rates of freedom from CD-TLR were 98% and 93%, respectively. Freedom from major amputation was 98% at both time points, and amputation-free survival was 93% and 85% at 6 and 12 months after the index procedure. Wound healing occurred in 31 patients (79%) with Rutherford category 5/6 ischemia by the end of 12 months. Conclusion: The Absorb BVS demonstrated good 1-year patency and clinical outcomes in CLTI patients with complex infrapopliteal disease.

Background: We report procedural and early results in the Netherlands of the Relay Branch device (Terumo Aortic, Sunrise, FL) for total endovascular repair of the aortic arch., Methods: Between 2014 and 2018, all consecutive patients who received the Aortic Relay double-branched stent graft in the Netherlands were included in a multicenter, retrospective registry., Results: The Relay Branch device was used in 11 patients to treat saccular (n = 4), fusiform (n = 5), or false aneurysms (n = 2) in the aortic arch. Patients were deemed unfit or extreme high-risk for open (redo) surgery. The brachiocephalic trunk and left common carotid artery were branched using a retrograde approach in all cases. Additional surgical left subclavian artery revascularization was performed in 8 patients. The main device and the branches were successfully introduced, positioned, and deployed with complete exclusion of the aortic pathology in all patients (100% technical success). There was no retrograde type A dissection or conversion to open surgery. Two procedure-related deaths occurred, both caused by perioperative or postoperative strokes. There were 2 minor strokes with full recovery. One patient recovered from transient paraplegia after spinal fluid drainage. No permanent paraplegia was observed. Follow-up imaging showed persistent adequate exclusion of aortic arch pathology. Mean follow-up was 17 months (range, 3-42 months)., Conclusions: Total endovascular aortic arch repair using the Relay Branch device is technically feasible and effective in excluding aortic arch pathology. The observed stroke rate in the initial experience, however, was considerable. Although appealing, this new less-invasive technique should be carefully introduced and its progress thoroughly evaluated., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

The aim of this systematic review is to assess the peer-reviewed literature on the psychometric properties, feasibility, effectiveness, costs, and current limitations of using telehealth and telemedicine approaches for prevention and management of diabetic foot disease. MEDLINE/PubMed was searched for peer-reviewed studies on telehealth and telemedicine approaches for assessing, monitoring, preventing, or treating diabetic foot disease. Four modalities were formulated: dermal thermography, hyperspectral imaging, digital photographic imaging, and audio/video/online communication. Outcome measures were: validity, reliability, feasibility, effectiveness, and costs. Sixty-one studies were eligible for analysis. Three randomized controlled trials showed that handheld infrared dermal thermography as home-monitoring tool is effective in reducing ulcer recurrence risk, while one small trial showed no effect. Hyperspectral imaging has been tested in clinical settings to assess and monitor foot disease and conflicting results on its diagnostic use show that this method is still in an experimental stage. Digital photography is used to assess and monitor foot ulcers and pre-ulcerative lesions and was found to be a valid, reliable, and feasible method for telehealth purposes. Audio/video/online communication is mainly used for foot ulcer monitoring. Two randomized controlled trials show similar healing efficacy compared with regular outpatient clinic visits, but no benefit in costs. In conclusion, several technologies with good psychometric properties are available that may be of benefit in helping to assess, monitor, prevent, or treat diabetic foot disease, but in most cases, feasibility, effectiveness, and cost savings still need to be demonstrated to become accepted and used modalities in diabetic foot care., (© 2019 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.)

Purpose: High-intensity focused ultrasound (HIFU) is a potential noninvasive thermal ablation method for the treatment of peripheral artery disease. Dual-mode ultrasound arrays (DMUA) offer the possibility of simultaneous imaging and treatment. In this study, safety and feasibility of femoral artery robot-assisted HIFU/DMUA therapy was assessed., Methods: In 18 pigs (∼50kg), angiography and diagnostic ultrasound were used to visualize diameter and blood flow of the external femoral arteries (EFA). HIFU/DMUA-therapy was unilaterally applied to the EFA dorsal wall using a 3.5 MHz, 64-element transducer, closed-loop-control was used to automatically adjust energy delivery to control thermal lesion formation. A continuous lesion of at least 25 mm was created by delivering 6-8 HIFU shots per imaging plane perpendicular to the artery spaced 1 mm apart. Directly after HIFU/DMUA-therapy and after 0, 3 or 14 days follow up, diameter and blood flow were measured and the skin was macroscopically examined for thermal damage. The tissue was removed for histological analysis., Results: No complications were observed. The most frequently observed treatment effect was formation of scar tissue, predominantly in the adventitia and the surrounding tissue. No damage to the endothelium or excessive damage of the surrounding tissue was observed. There was no significant decrease in the mean arterial diameter after HIFU/DMUA-therapy., Conclusion: HIFU/DMUA therapy successfully targeted the vessel walls of healthy porcine arteries, without causing endothelial damage or other vascular complications. Therefore, this therapy can be safely applied to healthy arterial walls in animals. Future studies should focus on safety and dose-finding in atherosclerotic diseased arteries.

Objective: Catheter directed thrombolysis (CDT) for acute arterial occlusions of the lower extremities is associated with a risk of major bleeding complications. Strict monitoring of vital functions is advised for timely adjustment or discontinuation of thrombolytic treatment. Nevertheless, current evidence on the optimal application of CDT and use of monitoring during CDT is limited. In this study the different standard operating procedures (SOPs) for CDT in Dutch hospitals were compared against a national guideline in a nationwide analysis., Methods: SOPs, landmark studies, and national and international guidelines for CDT for acute lower extremity arterial occlusions were compared. The protocols of 34 Dutch medical centres where CDT is performed were assessed. Parameters included contraindications to CDT, co-administration of heparin, thrombolytic agent administration, angiographic control, and patient monitoring., Results: Thirty-four SOPs were included, covering 94% of medical centres performing CDT in the Netherlands. None of the SOPs had identical contraindications and a strong divergence in relative and absolute grading was found. Heparin and urokinase dosages differed by a factor of five. In 18% of the SOPs heparin co-administration was not mentioned. Angiographic control varied between once every 6 h to once every 24 h. In 76% of the SOPs plasma fibrinogen levels were used for CDT dose adjustments. However, plasma fibrinogen level threshold values for treatment adjustments varied between 2.0 g/L and 0.5 g/L., Conclusion: The SOPs for CDT for acute arterial occlusions of the lower extremities differ greatly on five major operating aspects among medical centres in the Netherlands. None of the SOPs exactly conforms to current national or international guidelines. This study provides direction on how to increase homogeneity in guideline recommendations and to improve guideline adherence in CDT., (Copyright © 2019 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Secondary stent graft infection is a life-threatening complication after thoracic endovascular aortic repair (TEVAR). There is no consensus on optimal treatment strategy, but combined antibiotic and surgical treatment is advocated. Two years after his TEVAR procedure, a 70-year-old patient was admitted to the hospital with a secondary periaortic abscess. At first, the abscess was managed with clindamycin and transesophageal drainage. The abscess would not dissipate, and an infected iatrogenic aortoesophageal fistula was formed, which was surgically treated with esophageal resection, gastric tube reconstruction, and omental flap coverage., (Copyright © 2019 Elsevier Inc. All rights reserved.)

The extracranial carotid artery aneurysm (ECAA) is a rare pathology for which clinical treatment guidelines are lacking. In general, symptoms or growth of the aneurysm sac are thought to indicate intervention. ECAAs may present in a large variety of shapes and sizes, and conventional diameter measurements fail to indicate geometrical differences. Therefore, we propose a protocol to measure ECAA size by 3D volumetric assessment. The volumes of 40 ECAAs in computed tomography angiography (CTA) images were measured through manual segmentation, by two independent operators. Volumes of the entire internal carotid artery (ICA) and the ECAA were measured separately. Excellent inter- and intraoperator reliability was found for both ICA and ECAA volumes, with all intraclass correlation coefficients above 0.94. Bland-Altman analysis revealed normal differences for both inter- and intraoperator agreement. For all volumes, similarity of the segmentations was excellent. Outliers were explained by presence of intraluminal ECAA thrombus, which hampered identification of the aneurysm outer wall. These results implicate robustness of our protocol, which is designed as a step-up towards (semi)automatic volumetric measurements to monitor patients with ECAA. Future (semi)automatic volumetric assessments are recommended and such techniques can be developed and validated using the proposed protocol and manual reference segmentations.

A 24-year-old man presented with acute onset paraplegia related to complete occlusion of a thoracic stent graft placed 2 years prior for repair of traumatic type B aortic dissection. Following emergency surgery comprising reestablishment of aortic flow by stent removal and aortic reconstruction, the paraplegia started to resolve partly, despite an estimated 5-hour interval of preoperative myelum ischemia. Anatomical characteristics of the stent graft placement appear to have played a role in causing this rare complication. Six months later, the patient could walk again with a stick. This case shows that early intervention in cases of full paraplegia may be considered., (Copyright © 2019 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)