Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms.

OBJECTIVE: The European Society for Vascular Surgery (ESVS) has developed clinical practice guidelines for the care of patients with aneurysms of the abdominal aorta and iliac arteries in succession to the 2011 and 2019 versions, with the aim of assisting physicians and patients in selecting the best management strategy. METHODS: The guideline is based on scientific evidence completed with expert opinion on the matter. By summarising and evaluating the best available evidence, recommendations for the evaluation and treatment of patients have been formulated. The recommendations are graded according to a modified European Society of Cardiology grading system, where the strength (class) of each recommendation is graded from I to III and the letters A to C mark the level of evidence. RESULTS: A total of 160 recommendations have been issued on the following topics: Service standards, including surgical volume and training; Epidemiology, diagnosis, and screening; Management of patients with small abdominal aortic aneurysm (AAA), including surveillance, cardiovascular risk reduction, and indication for repair; Elective AAA repair, including operative risk assessment, open and endovascular repair, and early complications; Ruptured and symptomatic AAA, including peri-operative management, such as permissive hypotension and use of aortic occlusion balloon, open and endovascular repair, and early complications, such as abdominal compartment syndrome and colonic ischaemia; Long term outcome and follow up after AAA repair, including graft infection, endoleaks and follow up routines; Management of complex AAA, including open and endovascular repair; Management of iliac artery aneurysm, including indication for repair and open and endovascular repair; and Miscellaneous aortic problems, including mycotic, inflammatory, and saccular aortic aneurysm. In addition, Shared decision making is being addressed, with supporting information for patients, and Unresolved issues are discussed. CONCLUSION: The ESVS Clinical Practice Guidelines provide the most comprehensive, up to date, and unbiased advice to clinicians and patients on the management of abdominal aorto-iliac artery aneurysms.

Classification of anatomic patterns of peripheral artery disease with automated machine learning (AutoML).

AIM: The aim of this study was to investigate the potential of novel automated machine learning (AutoML) in vascular medicine by developing a discriminative artificial intelligence (AI) model for the classification of anatomical patterns of peripheral artery disease (PAD). MATERIAL AND METHODS: Random open-source angiograms of lower limbs were collected using a web-indexed search. An experienced researcher in vascular medicine labelled the angiograms according to the most applicable grade of femoropopliteal disease in the Global Limb Anatomic Staging System (GLASS). An AutoML model was trained using the Vertex AI (Google Cloud) platform to classify the angiograms according to the GLASS grade with a multi-label algorithm. Following deployment, we conducted a test using 25 random angiograms (five from each GLASS grade). Model tuning through incremental training by introducing new angiograms was executed to the limit of the allocated quota following the initial evaluation to determine its effect on the software's performance. RESULTS: We collected 323 angiograms to create the AutoML model. Among these, 80 angiograms were labelled as grade 0 of femoropopliteal disease in GLASS, 114 as grade 1, 34 as grade 2, 25 as grade 3 and 70 as grade 4. After 4.5 h of training, the AI model was deployed. The AI self-assessed average precision was 0.77 (0 is minimal and 1 is maximal). During the testing phase, the AI model successfully determined the GLASS grade in 100% of the cases. The agreement with the researcher was almost perfect with the number of observed agreements being 22 (88%), Kappa = 0.85 (95% CI 0.69-1.0). The best results were achieved in predicting GLASS grade 0 and grade 4 (initial precision: 0.76 and 0.84). However, the AI model exhibited poorer results in classifying GLASS grade 3 (initial precision: 0.2) compared to other grades. Disagreements between the AI and the researcher were associated with the low resolution of the test images. Incremental training expanded the initial dataset by 23% to a total of 417 images, which improved the model's average precision by 11% to 0.86. CONCLUSION: After a brief training period with a limited dataset, AutoML has demonstrated its potential in identifying and classifying the anatomical patterns of PAD, operating unhindered by the factors that can affect human analysts, such as fatigue or lack of experience. This technology bears the potential to revolutionize outcome prediction and standardize evidence-based revascularization strategies for patients with PAD, leveraging its adaptability and ability to continuously improve with additional data. The pursuit of further research in AutoML within the field of vascular medicine is both promising and warranted. However, it necessitates additional financial support to realize its full potential.

Outcomes of Percutaneous Access to the First Versus Third Segment of Axillary Artery During Aortic Procedures.

PURPOSE: This article aims at investigating the outcomes of percutaneous access via the first versus third axillary artery (AXA) segments with closure devices during aortic procedures. MATERIALS AND METHODS: All patients receiving percutaneous AXA access closed with Perclose ProGlide device (Abbott, Santa Clara, California) from 2008 to 2021 were included in a retrospective multicenter registry (NCT: 04589962). Efficacy endpoint was the technically successful percutaneous procedure (no open conversion). Safety endpoints were stroke and access complications according to the Valve Academic Research Consortium-3 reporting standards. The first (AXA1) or third (AXA3) axillary puncture sites were compared. RESULTS: A total of 412 percutaneous AXA accesses were included: 172 (42%) in AXA1 and 240 (58%) in AXA3. Left AXA was catheterized in 363 cases (76% of AXA1 vs 97% of AXA3, p<0.001) and 91% of fenestrated/branched endovascular repair (F/BEVAR) procedures were conducted from the left. A ≥12F internal diameter (ID) sheath was used in 49% of procedures. Open conversion rate was 1%, no major vascular complications occurred, and only one major non-vascular complication was recorded. Primary closure failure occurred in 18 AXA1 (11%) and 32 AXA3 accesses (13%), treated by covered (8.3%) or bare-metal (2.7%) stenting. Bailout stent patency was 100% at median follow-up of 12 months, with 6 of 6 stents still patent after >36 months of follow-up. Stroke rate was 4.4%. An introducer sheath >12F was independently associated with both access complications (p<0.001) and stroke (p=0.005), while a right-side access was associated with stroke only (p=0.034). Even after adjustment for covariates, AXA1 versus AXA3 showed an equal success rate (odds ratio [OR]=0.537, 95% confidence interval [CI]=0.011-1.22 for AXA3, p=0.104). The combination of AXA3 and a >10F introducer sheath provided worse outcomes compared with >10F sheaths through AXA1 (OR for success=0.367, 95% CI=0.176-0.767, p=0.008). This was not confirmed for >12F sheaths, associated with similar outcomes (p=0.31 AXA 1 vs AXA 3). CONCLUSION: Major local complications with the percutaneous axillary approach and ≤12F sheaths are infrequent and solvable by complementary endovascular interventions. Stroke risk remains an issue. First and third AXA segments are both amenable for access with good results, but larger sheaths (12F) perform better in AXA1. CLINICAL IMPACT: Percutaneous access with vascular closure devices at the first or third axillary artery (AXA) segments during aortic procedures is burdened by a negligible risk of open conversion. Local complications with the percutaneous axillary approach are infrequent and solvable by complementary endovascular interventions. First and third AXA segments are both amenable to access with excellent results, but larger sheaths (12F) perform better in the wider first AXA segment. In this setting, bailout stenting does not appear to be associated with mid-term stent occlusion.

Clonal Hematopoiesis Mutations Are Present in Atherosclerotic Lesions in Peripheral Artery Disease.

Clonal hematopoiesis (CH)-associated mutations increase the risk of atherosclerotic cardiovascular diseases. However, it is unclear whether the mutations detected in circulating blood cells can also be detected in tissues associated with atherosclerosis, where they could affect physiology locally. To address this, the presence of CH mutations in peripheral blood, atherosclerotic lesions and associated tissues was assessed in a pilot study of 31 consecutive patients with peripheral vascular disease (PAD) who underwent open surgical procedures. Next-generation sequencing was used to screen the most commonly mutated loci (DNMT3A, TET2, ASXL1 and JAK2). Twenty CH mutations were detected in peripheral blood of 14 (45%) patients, 5 of whom had more than one mutation. TET2 (11 mutations, 55%) and DNMT3A (8 mutations, 40%) were the most frequently affected genes. Altogether, 88% of the mutations detectable in peripheral blood were also present in the atherosclerotic lesions. Twelve patients also had mutations in perivascular fat or subcutaneous tissue. The presence of CH mutations in PAD-associated tissues as well as in blood suggests that CH mutations may make a previously unknown contribution to PAD disease biology.

First Experience With The GoBack-Catheter For Successful Crossing of Complex Chronic Total Occlusions in Lower Limb Arteries.

PURPOSE: To evaluate the use of the GoBack-catheter (Upstream Peripheral Technologies) in complex revascularizations in lower limb arteries. MATERIALS AND METHODS: In this retrospective single-center study, the results of the first 100 consecutive patients including 101 limb-revascularizations, performed between May 2018 and July 2020 with the study device, were analyzed. In all cases, guidewire-crossing failed, and all lesions were chronic total occlusions (CTO), either de novo, reocclusions, or in-stent reocclusions. Successful crossing was defined as passing the CTO using the study device. Patency at discharge and after 30 days was defined as less than 50% restenosis on duplex sonography, without target lesion revascularization. RESULTS: Median lesion length was 24 cm and 38 patients (37.6%) had a calcium grading according to the peripheral arterial calcium scoring system (PACSS) of 4 or 5. In 20.8% of patients, an occluded stent was treated. CTOs involved the femoropopliteal segment in 91.1%, iliac arteries in 5.9%, and tibial arteries in 7.9%. The GoBack-catheter was employed for entering into or crossing through parts or the full length of a CTO or an occluded stent as well as for re-entering into the true lumen after subintimal crossing. The device was used via contralateral and ipsilateral antegrade as well as retrograde access with an overall technical success rate of 92.1%. In 3 patients minor bleeding occurred at the crossing or re-entry site, which were managed conservatively. Thirty-day adverse limb events comprised minor amputations in 4 patients (4.0%), 1 major amputation (1.0%), and reocclusions in 7 limbs (6.9%). CONCLUSION: The new GoBack-catheter offers versatile endovascular applicability for complex CTO recanalization in a broad range of peripheral vascular interventions with a high technical success and low complication rate.

Type II endoleak and aortic aneurysm sac shrinkage after preemptive embolization of aneurysm sac side branches.

OBJECTIVE: Type II endoleak (T2EL) is the most common endoleak after endovascular aneurysm repair (EVAR). Its optimal management has been controversially discussed. Thus, preliminary selective embolization of aneurysm sac side branches (ASSBs) has been adopted to prevent T2EL. Our goal was to determine the rate of T2EL and the diameter decrease of abdominal aortic aneurysms (AAAs) after EVAR performed after preemptive embolization of ASSBs. METHODS: From September 2014 to September 2019, 139 patients with AAAs underwent percutaneous ASSB embolization before EVAR. Follow-up imaging studies were performed at 1 and 6 months and annually thereafter. The end points included freedom from T2EL, AAA sac shrinkage, T2EL-related reinterventions, and all-cause mortality. RESULTS: The mean follow-up was 23 ± 16 months (range, 1-61 months). The patients had had a median of five (range, one to eight) patent ASSBs found on preoperative imaging studies. After completion of embolization, 76.4% of the initially patent ASSBs were occluded, with no major procedure-related complications. Follow-up imaging studies showed T2ELs in seven patients (5%), with an aneurysm sac increase seen in six of these patients. The number of ASSBs remaining patent after embolization was the only discriminative factor in patients with and without T2EL. Six T2EL-related reinterventions were performed during follow-up. Most patients (n = 91; 86.7%) had experienced aneurysm sac shrinkage, and the mean diameter reduction was 9.2 ± 7.7 mm (P < .001) in all patients with follow-up data available. One aneurysm-related death occurred within 30 days after EVAR. CONCLUSIONS: Preemptive embolization of ASSBs for patients with AAAs is safe and effective in preventing T2ELs after EVAR. Aneurysm sac shrinkage was observed in a high proportion of patients.

First-in-Human Clinical Application of the Medyria TrackCath System in Endovascular Repair of Complex Aortic Aneurysms (ACCESS Trial): A Prospective Multicenter Single-Arm Clinical Trial.

PURPOSE: The Medyria TrackCath Catheter (MedTCC) is an innovative, thermal convection-based blood flow velocity (BFV) tracking catheter that may be used during complex aortic endovascular procedures for identification and catheterization of target orifices. The ACCESS Trial analyzes the safety and performance of the MedTCC for targeted vessel catheterization to generally evaluate the feasibility of thermal convection-based BFV. MATERIALS AND METHODS: We performed a first-in-human, proof-of-concept, prospective single-arm multicenter clinical trial between March 2018 and February 2019 in patients who underwent endovascular aortic procedures at 4 high-volume centers. During these procedures, the MedTCC was advanced over a guidewire through the femoral access. The D-shape was enfolded in the reno-visceral part of the aorta and target orifices were identified and catheterized with a guidewire via the side port of the MedTCC through BFV tracking. BFV measurements were performed at baseline (Baseline-BFV), alignment to the orifice (Orifice-BFV), and following catheterization (Confirmation-BFV) to prove correct identification and catheterization of target orifices. The procedural success rate, the catheterization success rate, procedure-related parameters, and (serious) adverse events ((S)AE) during the follow-up were analyzed. RESULTS: A total of 38 patients were included in the safety group (SG) and 26 in the performance group (PG). The procedural success rate was 89% (PG), the MedTCC catheterization success rate was 98% (PG). The MedTCC reliably measured BFV changes indicated by significant differences in BFV between Baseline-BFV and Orifice-BFV (p<0.05). Median (interquartile range; IQR) fluoroscopy time per orifice was 5.0 (1.5-8.5) minutes [total surgery 49 (26-74) minutes], median (IQR) contrast agent used per orifice was 1.0 (0-5.0) mL [total surgery 80 (40-100) mL], and median (IQR) MedTCC-based procedural time was 3.0 (2.0-6.0) minutes. There was no device-related SAE. CONCLUSIONS: The ACCESS Trial suggests that BFV measurement allows for reliable target orifice identification and catheterization. The use of MedTCC is safe and generates short fluoroscopy time and low contrast agent use, which in turn might facilitate complex endovascular procedures.

The Influence of 3D Printed Aortic Models on the Evolution of Physician Modified Stent Grafts for the Urgent Treatment of Thoraco-abdominal and Pararenal Aortic Pathologies.

OBJECTIVE: The aim was to describe the outcomes of high risk patients with symptomatic or contained rupture of pararenal (PRAs) and thoraco-abdominal aortic aneurysms (TAAAs) with anatomy unsuitable for commercially available stent grafts who underwent fenestrated endovascular aneurysm repair (FEVAR) using physician modified stent grafts (PMSGs) planned with 3D image analysis software (3DIMAS), and 3D printed aortic models (3DAMs). METHODS: Nineteen consecutive patients (17 male; mean age, 70 ± 9 years) underwent PMSG-FEVAR between 2015 and 2019. 3DAMs to plan the PMSGs were introduced in 2018. End points were all cause mortality, freedom from any endoleak, target vessel patency, and re-intervention. RESULTS: Seven patients (36.8%) were treated with PMSGs using 3DIMAS (three PRAs, three type IV, and one type III TAAAs), and 12 patients (63.2%) received PMSGs using 3DAMs (five PRAs, seven type IV TAAAs). Six patients presented with contained aortic rupture and 13 patients were treated for symptomatic aortic aneurysm. Mean aortic diameter was 72 ± 10 mm. The choice of stent graft for fenestration was the Valiant Captivia Closed Web (Medtronic), except for one patient. Sixteen (84.2%) stent grafts were manufactured with four fenestrations. Technical success was 100%. Seventy-one renovisceral branch vessels were targeted with fenestrations. Mean length of hospital stay was 17.3 ± 10.4 days. Thirty day mortality was 0%. Two patients developed reversible spinal cord injury. Mean follow up was 14.4 months (range 1-52 months). During follow up one non-aneurysm related death occurred, and two successful re-interventions were performed: one to re-establish renal artery patency, and one to treat a type 1c endoleak. CONCLUSION: PMSGs for urgent treatment of pararenal and thoraco-abdominal aortic aneurysms in high risk patients unsuitable for commercially available stent grafts are feasible and safe. 3D printing technology may improve urgent construction of patient specific devices for treatment of complex aortic pathologies and improve outcomes.

Spondylodiscitis due to transmitted mycotic aortic aneurysm or infected grafts after endovascular aortic aneurysm repair (EVAR): A retrospective single-centre experience with short-term outcomes.

PURPOSE: To report the challenging therapeutic approach and the clinical outcome of patients with pyogenic spondylodiscitis transmitted due to infected retroperitoneal regions of primary infected mycotic aortic aneurysms (MAAs) or secondary infected aortic stent grafts after endovascular aneurysm repair (EVAR). METHODS: Between 2012 and 2019, all patients suffering from spondylodiscitis based on a transmitted infection after the EVAR procedure were retrospectively identified. Patient data were analysed regarding the time between primary and secondary EVAR infection and spondylodiscitis detection, potential source of infection, pathogens, antibiotic treatment, complications, recovery from infection, mortality, numeric rating scale (NRS), COBB angle and cage subsidence. RESULTS: Fifteen patients with spondylodiscitis transmitted from primary or secondary infected aortic aneurysms after EVAR were included. The median follow-up time was 8 months (range 1-47). Surgery for spondylodiscitis was performed in 12 patients. In 9 patients, the infected graft was treated conservatively. MAAs were treated in 4 patients first with percutaneous aortic stent graft implantation followed by posterior surgery of the infected spinal region in a two-step procedure. Infection recovery was recorded in 11 patients during follow-up. The overall mortality rate was 27% (n = 4). The mean pain intensity improved from an NRS score of 8.4 (3.2-8.3) to 3.1 (1.3-6.7) at the last follow-up. CONCLUSION: EVAR was used predominantly to treat primary infected MAAs. Secondary infected grafts were treated conservatively. Independent of vascular therapy, surgery of the spine led to recovery in most cases. Thus, surgery should be considered for the treatment of EVAR- and MAA-related spondylodiscitis.

Pre-operative ankle-brachial index for cardiovascular risk assessment in simultaneous pancreas-kidney transplant recipients: a simple and elegant strategy!

BACKGROUND: Patients with insulin-dependent diabetes mellitus type 1 (IDDM1) and end-stage kidney disease (ESKD) undergoing simultaneous pancreas kidney transplantation (SPKT) are a population with diffuse atherosclerosis and elevated risk of cardio- and cerebrovascular morbidity and mortality. We aimed to investigate the feasibility of preoperative screening for peripheral arterial disease (PAD), specifically ankle-brachial index (ABI) testing, to predict peri- and postoperative outcomes in SPKT recipients. METHODS: Medical data (2000-2016) from all patients with IDDM and ESKD undergoing SPKT at our transplant center were retrospectively analyzed. The correlation between PAD (defined by an abnormal ABI before SPKT and graft failure and mortality rates as primary end points, and the occurrence of acute myocardial infarction, cerebrovascular and peripheral vascular complications as secondary end points were investigated after adjustment for known cardiovascular risk factors. RESULTS: Among 101 SPKT recipients in our transplant population who underwent structured physiological arterial studies, 17 patients (17%) were diagnosed with PAD before transplantation. PAD, as defined by a low ABI index, was an independent and significant predictor of death (HR, 2.99 (95% CI 1.00-8.87), p = 0.049) and pancreas graft failure (HR, 4.3 (95% CI 1.24-14.91), p = 0.022). No significant differences were observed for kidney graft failure (HR 1.85 (95% CI 0.76-4.50), p = 0.178). In terms of the secondary outcomes, patients with PAD were more likely to have myocardial infarction, stroke, limb ischemia, gangrene or amputation (HR, 2.90 (95% CI 1.19-7.04), p = 0.019). CONCLUSIONS: Pre-transplant screening for PAD and cardiovascular risk factors with non-invasive ABI testing may help to reduce perioperative complications in high-risk patients. Future research on long-term outcomes might provide more in depth insights in optimal treatment strategies for PAD among SPKT recipients.

Stroke rate after thoracic endovascular aortic repair using de-airing of stentgrafts with high-volume of saline solution.

Background: Our aim was to determine the rate of ischemic stroke following thoracic endovascular aortic repair (TEVAR) after reducing gas volume released during stentgraft deployment by de-airing of thoracic stentgrafts with high-volume of 0.9% heparinized saline solution. Patients and methods: A single center retrospective analysis of all consecutive patients undergoing TEVAR from 2014 to 2019 was performed. All thoracic stentgrafts were flushed with 120 ml 0.9% heparinized saline solution before implantation, according to our institutional protocol. Endpoints were in-hospital rates of ischemic stroke and spinal cord ischemia (SCI), and all-cause mortality. Results: One hundred and fifty-four patients (mean age: 66.8 ± 13.6 years, 64.9% males) were treated with TEVAR during the study period. Indications for treatment were thoracic aortic aneurysms (n = 75, 48.7%), acute type B aortic dissections (n = 46, 29.9%), aortic arch aneurysms and penetrating aortic ulcers (n = 28, 18.2%), and blunt traumatic aortic injuries (n = 5, 3.2%). Timing of procedure was urgent in 75 patients (48.7%). Proximal landing zone were zone 0-1-2 (n = 75, 48.7%), zone 3 (n = 66, 42.9%) and zone 4 (n = 13, 8.4%). Supra-aortic vessels were revascularized with custom-made fenestrated stentgrafts in 9 patients (5.8%), using chimney technique in 4 patients (2.6%), and with debranching procedures in 19 patients (12.3%). Left subclavian artery was covered without revascularization in 46 patients (29.9%). In-hospital stroke occurred in two patients (1.3%) and SCI in another two patients (1.3%). In-hospital mortality rate was 0.6%. No further in-hospital events were noted. Conclusions: De-airing of stentgrafts with high-volume of 0.9% heparinized saline solution seems to be safe and can be used as an adjunct to keep occurrence of neurological events after TEVAR as low as possible.

[Surgeon-modified Stent Grafts for Complex Aortic Reconstructions - What is Feasible?] / Surgeon-modified Stentgrafts für komplexe Aortenrekonstruktionen ­ was ist möglich?

BACKGROUND: The close anatomical relationship to the visceral vessels renders the treatment of complex throacoabdominal aortic pathologies challenging. In emergent cases, off-the-shelf stent grafts and parallel techniques are feasible treatment options. Alternatively, the treating surgeon can alter a conventional stent graft, creating a so-called surgeon-modified stent graft (SMSG) to adapt it to the complex aortic pathology. The aim of this publication is to present the possibilities and results of this method. RESULTS: The location of SMSG's fenestrations can be determined after manual measurements of the centerline of flow reconstructions of the aortic computed tomography-angiography. The planning of the SMSG can be simplified and standardized by creating personalized 3D aortic models, and by using algorithms for the automated determination of the ideal fenestration positions. Most approved stent grafts can be used as platforms for SMSG. Different manufacturing techniques have been described. In addition to simple fenestrations, mini-cuffs, directional branches, and inner branches are used. Furthermore, diameter reducing ties and preloaded catheters could facilitate the implantation. The treatment of complex aortic pathologies using SMSG has achieved good results, with high technical success rate of 90-100%, and low 30-day mortality, especially when compared to open surgical treatment of similar patients. The rate of endoleak of 0-14% was also acceptable. Long-term durability results after treatment with SMSG are not yet available. CONCLUSION: Surgeon-modified stent grafts are safe and feasible for the endovascular treatment of patients with urgent complex thoracoabdominal aortic pathologies. They represent compassionate use and show promising results in the published literature.

Midterm Outcomes of Percutaneous Deep Venous Arterialization With a Dedicated System for Patients With No-Option Chronic Limb-Threatening Ischemia: The ALPS Multicenter Study.

Purpose: To evaluate the midterm results of patients suffering from no-option chronic limb-threatening ischemia (CLTI) treated with a dedicated system for percutaneous deep venous arterialization (pDVA). Materials and Methods: Thirty-two consecutive CLTI patients (mean age 67±14 years; 20 men) treated with pDVA using the Limflow device at 4 centers between 11 July 2014 and 11 June 2018 were retrospectively analyzed. Of all patients, 21 (66%) had diabetes, 8 (25%) were on immunosuppression, 4 (16%) had dialysis-dependent renal failure, 9 (28%) had Rutherford category 6 ischemia, and 25 (78%) were deemed at high risk of amputation. The primary outcome was amputation-free survival (AFS) at 6 months. Secondary outcomes were wound healing, limb salvage, and survival at 6, 12, and 24 months. Results: Technical success was achieved in 31 patients (96.9%). The median follow-up was 34 months (range 16-63). At 6, 12, and 24 months, estimates were 83.9%, 71.0%, and 67.2% for AFS, 86.8%, 79.8% and 79.8% for limb salvage, and 36.6%, 68.2%, and 72.7% for complete wound healing, respectively. Median time to complete wound healing was 4.9 months (range 0.5-15). The DVA circuit occluded during follow-up in 21 patients; the median time to occlusion was 2.6 months. Reintervention for occlusion was performed in 17 patients: 16 because of unhealed wounds and 1 for a newly developed ulcer. Conclusion: This study represents the largest population of patients with no-option CLTI treated with pDVA using the LimFlow device with midterm results. In this complex group of patients, pDVA using the LimFlow device has been shown to be feasible, with a high technical success rate and AFS at 6 up to 24 months coupled with wound healing. In selected patients with no-option CLTI, pDVA could be a recommended treatment to prevent amputation and heal wounds.

Percutaneous Axillary Artery Access for Endovascular Treatment of Complex Thoraco-abdominal Aortic Aneurysms.

OBJECTIVE: The aim of this study was to determine the feasibility and safety of percutaneous axillary artery (AxA) access using vascular closure devices (VCD) for endovascular repair (ER) of thoraco-abdominal aortic aneurysms (TAAA) using fenestrated, branched, and chimney stent grafts. METHODS: Between September 2013 and December 2017, 40 high risk patients (27 men; mean age: 72.7 ± 7.4 years) with TAAA underwent total percutaneous endovascular aortic repair by percutaneous puncture of the third segment of the left AxA, using a 12F sheath for delivery of the bridging visceral stent grafts. Percutaneous closure was performed using ultrasound guidance and two Perclose ProGlide VCDs per puncture site. Endpoints were device success defined as successful haemostasis of the axillary puncture site by VCD, procedure success defined as endovascularly assisted haemostasis of the AxA, major cerebrovascular and peripheral neurological complications, and 30 day mortality. RESULTS: The median diameter of the AxA in the third segment was 6.5 mm (range 4.4-10.4 mm). The procedure success was 100%. Device success was achieved in 33 patients (82.5%). Device success in patients with AxA diameter >5 mm was 97%. All patients with diameter of the AxA <5 mm developed stenosis or occlusions of the vessel (n = 6), which were treated by percutaneous stent implantation. One bleeding at the AxA puncture site was treated with trans-femoral implantation of a covered stent. No secondary open procedures were required. No neurological deficit of the left upper limb was seen at discharge. Overall mortality at 30 days was 10%. CONCLUSIONS: Direct puncture of the AxA in the third segment and its use as an access vessel for large sheaths during total percutaneous treatment of complex endovascular aortic procedures appear to be feasible and safe in arteries with a diameter >5 mm. Complications can be managed using endovascular techniques.

Endovascular Treatment of Severely Calcified Femoropopliteal Lesions Using the "Pave-and-Crack" Technique: Technical Description and 12-Month Results.

PURPOSE: To report midterm results of the "pave-and-crack" technique to facilitate safe and effective scaffolding of heavily calcified femoropopliteal lesions in preparation for delivery of a Supera interwoven stent. METHODS: Data were collected retrospectively on 67 consecutive patients (mean age 71±8 years; 54 men) treated with this technique between November 2011 and February 2017 at a single center. A third (22/64, 34%) of the patients had critical limb ischemia (CLI). Most lesions were TASC D (52/67, 78%), and the majority were occlusions (61/66, 92%). The mean lesion length was 26.9±11.2 cm. Nearly two-thirds (40/64, 62%) had grade 4 calcification (Peripheral Arterial Calcium Scoring System). To prepare for Supera stenting, the most heavily calcified segments of the lesion were predilated aggressively to obliterate recoil. A Viabahn stent-graft was then implanted to "pave" the lesion and protect from vessel rupture as aggressive predilation continued until the calcified plaque was "cracked" before lining the entire lesion with a Supera stent. Patency and target lesion revascularization (TLR) rates were estimated using the Kaplan-Meier method. RESULTS: Procedural success was achieved in 100% and technical success (residual stenosis <30%) in 98% (66/67). The mean cumulative stent lengths were 16±9 cm for the Viabahn and 23±12 cm for the Supera. Only 2 complications occurred (distal embolization and access-site pseudoaneurysm). Two CLI patients died within 30 days, and 3 patients (all claudicants) underwent a TLR. Patients were followed for a mean 19±18 months, during which another 2 CLI patients died and 1 patient had a major amputation. One-year primary and secondary patency estimates were 79% and 91%, respectively; freedom from TLR was 85%. CONCLUSION: Despite severe lesion calcification, patients experienced high technical success and a safe and durable therapy at midterm follow-up with the femoropopliteal "pave-and-crack" technique.

Renal denervation for hypertension refractory to renal artery stenting.

PURPOSE: To investigate the effect of renal denervation (RDN) on blood pressure and renal function in refractory hypertension after renal artery recanalization and optimal medical therapy. METHODS: Ten patients (6 women; mean age 70.0±5.1 years) with an office systolic blood pressure >160 mmHg despite taking ≥3 antihypertensive drugs and uni- or bilateral renal artery stenting were treated with RDN. Radiofrequency (RF) energy was delivered to the native segment of the artery keeping a 5-mm safe distance from the stented segments. Standardized office (OBP) and ambulatory (ABP) blood pressure measurements, medication, and renal assessment, including renal duplex ultrasound and renal function, were determined at baseline and on follow-up to 12 months. RESULTS: OBP (systolic/diastolic) at baseline was 190.0±20.4 / 84.2±10.1 mmHg. It decreased to 171.1±28.7* / 82.2±8.7, 165.5±28.4(†) / 76.1±7.4, and 158.3±14.2(†) / 75.5±9.5(†) mmHg (*p<0.001; (†)p<0.01) at 3, 6, and 12 months after RDN, respectively. Average ABP (systolic/diastolic) after 6 and 12 months decreased by -7.6(‡) / -3.1 and -11.3(‡) / -5.1(‡) mmHg ((‡)p<0.05). There was no renal artery (re)stenosis, dissection, or aneurysm within 12 months. Creatinine, cystatin C, and glomerular filtration rate remained unchanged. Urine albumin excretion decreased in 4/10 patients. Renal resistive indices improved in native, but not in stented renal arteries within the follow-up period. CONCLUSION: This proof-of-concept study demonstrates that RF-based RDN can be safely and effectively delivered in patients with resistant hypertension and previous renal artery stenting.