Report of a semi-branched stent-graft to treat a type 1a endoleak after failed EVAR.

BACKGROUND: Endovascular techniques are advancing with the change of treatment paradigm for abdominal aortic aneurysms. Fenestrated EVAR (fEVAR) and branched EVAR (bEVAR) are used for complex aortic aneurysm repair. Both fEVAR and bEVAR have their own advantages and disadvantages. Semi-branches are a new feature that attempt to combine the advantages of both fEVAR and bEVAR. TECHNIQUE: We describe the use of a 4-vessel semi-branched EVAR in a failed EVAR case with a type 1a endoleak. CONCLUSION: The novel feature of semi-branches in custom-made EVAR devices in endovascular aortic treatment following failed EVAR appear to be a feasible option.

Impact of low dose superparamagnetic iron oxide tracer for sentinel node biopsy in breast conserving treatment on susceptibility artefacts on magnetic resonance imaging and contrast enhanced mammography.

BACKGROUND: Residual particles of superparamagnetic iron oxide (SPIO) tracer, used for sentinel node biopsy, cause susceptibility artefacts on breast Magnetic Resonance Imaging (MRI). We investigated the impact of these artefacts on the imaging quality of MRI and explored whether contrast-enhanced mammography (CEM) could be an alternative in the follow-up of breast cancer patients. MATERIALS AND METHODS: Data on patients' characteristics, injection site, presence, size (mm) of artefacts on full-field digital mammography (FFDM)/CEM, MRI after 1 ml SPIO was recorded. Image quality scored by two breast radiologists using a 4-point Likert system: 0: no artefacts 1: good diagnostic quality 2: impaired but still readable 3: hampered clinical assessment. Continuous variables reported as means and standard deviations (SD), categorical variables as count and percentage. RESULTS: On FFDM/CEM, performed 13 months postoperatively, no iron SPIO particles were detected, with a Likert score of 0. In all MRI (100%) images, executed at 16.6 months after SPIO injection, susceptibility artefacts at the injection sites i.e., retroareolair and lateral quadrant were observed with a mean size of 41.9 ± 9.8 mm (SD) by observer 1, and 44.8 ± 12.5 mm (SD) by observer 2, independent of the injection site. Both observers scored a Likert score of 2: locally impaired on all MRI images and sequences. CONCLUSIONS: Even 1 ml SPIO tracer used for sentinel node procedure impairs the evaluation of breast MRI at the tracer injection site beyond one year of follow-up. No impairment was observed on FFDM/CEM, suggesting that CEM might be a reliable alternative to breast MRI if required.

Differentiating between segmental arterial mediolysis and other arterial vasculopathies to establish an early diagnosis - a systematic literature review and proposal of new diagnostic criteria.

Segmental arterial mediolysis (SAM) is a rare vascular disease, characterized by acute but transient vulnerability of the wall of medium-sized arteries. The most characteristic feature of SAM is its biphasic course: an injurious phase marked by acute weakness of the arterial wall leading to acute dissection and/or hemorrhage, followed by a reparative phase in which granulation tissue and fibrosis restore the injured arterial wall. Residual stenosis, aneurysms, and/or arterial wall irregularities may remain visible on future imaging studies. Differentiating between SAM and other arterial vasculopathies is difficult due to its similarities with many other vascular diseases, such as vasculitis, fibromuscular dysplasia, inherited connective tissue disorders, and isolated visceral artery dissection. In this systematic review, we provide an overview on SAM, with an emphasis on the differential diagnosis and diagnostic work-up. We propose new diagnostic criteria to help establish a prompt diagnosis of SAM, illustrated by case examples from our multidisciplinary vascular clinic.

Clinical outcomes of MANTA closure device in percutaneous endovascular aortic aneurysm repair.

OBJECTIVE: The MANTA device is a plug-based vascular closure device (VCD) designed for large bore femoral arterial access site closure. It showed promising results in transcatheter aortic valve replacement cases. In this study, we report our results and evaluate the MANTA VCD in percutaneous endovascular aortic aneurysm repair (pEVAR). METHODS: All data of consecutive patients who underwent an elective pEVAR between October 2018 and December 2022 were retrospectively reviewed. In all patients at least one common femoral artery was intended to close with the MANTA VCD. Depending on the sheath size, the 14Fr or 18Fr MANTA VCD was used. On the preoperative computed tomography scan, the diameter of the common femoral artery (CFA) was measured and the amount of calcification based on the Peripheral Arterial Calcium Scoring System (PACSS) was scored. Primary outcome was procedural technical success. Procedural technical success was defined as placement of the MANTA closure device resulting in vascular closure with patent CFA, without requiring immediate open or endovascular surgery. The secondary outcomes were access site complications requiring reintervention and all-cause mortality at 30-day follow-up. RESULTS: In total, 152 consecutive patients underwent pEVAR with 291 common femoral artery closure procedures with the Manta VCD. Mean age was 74.1 ± 6.4 years, with a mean body mass index of 27.7 ± 4.4 kg/m2. The mean diameter of the CFA was 10.5 ± 1.9 mm. In 52.6% of the cases, there were no calcification on the preoperative computed tomography scan. The 18Fr and 14Fr Manta VCD were used 169 and 122 times, respectively. The technical success rate was 96.6%. Major vascular complications were reported in 4.5% of the cases, without any death-related events. CONCLUSIONS: This single-center retrospective cohort study analyzed the procedural technical success, major vascular complications and all-cause mortality at 30-day follow-up of the MANTA vascular closure device in 152 pEVAR patients with 291 common femoral artery closure procedures. The technical success rate was 96,6%. Major vascular complications were reported in 4.5% of the cases, without any death related events. We concluded that the MANTA device is a safe and feasible option with a high rate of technical success in patients undergoing pEVAR.

Single-Center Experience With Inner-Branched Endograft for the Treatment of Pararenal Abdominal Aortic Aneurysms.

PURPOSE: To report a single-center result of patients with pararenal aneurysms treated with inner-branched endograft. MATERIALS AND METHODS: This retrospective study analyzed prospectively collected data of patients treated with elective inner-branched endovascular aneurysm repair (iBEVAR) using an Artivion® E-xtra custom-made endograft. Primary endpoints were clinical and technical success after iBEVAR. Secondary endpoints were overall survival, target vessel patency during follow-up, aneurysm-related mortality, and freedom from reintervention. RESULTS: Over a 56-month period, a total of 23 patients (19 men; 72.3±7.2 years) were treated with iBEVAR with a mean follow-up of 15 months. Technical success was achieved in 96% of procedures, incorporating 87 inner branches. Two (8.3%) intraoperative complications (target vessel dissection) were reported, without additional reinterventions needed. Two (8.3%) patients died within 30 days after initial procedure. One due to respiratory failure and the other from an ischemic stroke. During follow-up, 3 patients (13%) required reintervention, either to repair a type I or type III endoleak (n=2) or to place an iliac-branched device, that did not succeed during the initial iBEVAR procedure (n=1). Primary target vessel patency and freedom from reintervention during follow-up was, respectively, 98.9% and 87%. We revealed no aneurysm-related mortality. Overall survival was 78.3%. CONCLUSION: The present study confirms previous findings that iBEVAR on the Artivion® E-xtra design platform is an effective and safe procedure achieving high technical success rate in the treatment of pararenal abdominal aortic aneurysms. CLINICAL IMPACT: Inner branched stent-graft configuration combines the benefits of FEVAR and outer-branched stent-graft technology. Implementation of inner branches in stent-grafts is gradually becoming more widespread for the treatment of aneurysms. This report supports the safe and high technical success rate of inner branched stent-grafts in treatment of pararenal abdominal aortic aneurysms.

Impact of analysis of the sentinel lymph node by one-step nucleic acid amplification (OSNA) compared to conventional histopathology on axillary and systemic treatment: data from the Dutch nationwide cohort of breast cancer patients.

PURPOSE: The outcome of the sentinel lymph node in breast cancer patients affects adjuvant treatment. Compared to conventional histopathology, analysis by one-step nucleic acid amplification (OSNA) harvests more micrometastasis, potentially inducing overtreatment. In this study we investigated the impact of OSNA analysis on adjuvant treatment, compared to histopathological analysis. METHODS: Data from T1-3 breast cancer patients with sentinel nodes analysed between January 2016 and December 2019 by OSNA (OSNA group, n = 1086) from Zuyderland Medical Centre, the Netherlands, were compared to concurrent data from the Netherlands Cancer Registry (NKR) where sentinel nodes were examined by histology (histology group, n = 35,143). Primary outcomes were micro- or macrometastasis, axillary treatments (axillary lymph node dissection (ALND) or axillary radiotherapy (ART)), chemotherapy, and endocrine therapy. Statistics with Pearson Chi-square. RESULTS: In the OSNA group more micrometastasis (14.9%) were detected compared to the histology group (7.9%, p < 0.001). No difference in axillary treatment between groups was detected (14.3 vs. 14.4%). In case of mastectomy and macrometastasis, ALND was preferred over ART in the OSNA group (14.9%) compared to the histology group (4.4%, p < 0.001). In cases of micrometastasis, no difference was seen. There was no difference in administration of adjuvant chemotherapy between groups. Endocrine treatment was administrated less often in the OSNA group compared to the histology group (45.8% vs. 50.8%, p < 0.002). CONCLUSION: More micrometastasis were detected by OSNA compared to histopathology, but no subsequent increase in adjuvant axillary and systematic treatment was noticed. When performing mastectomy and OSNA, there was a preference for ALND compared to ART.

Guideline recommendations on minimal blood vessel diameters and arteriovenous fistula outcomes.

OBJECTIVE: Clinical guidelines provide recommendations on the minimal blood vessel diameters required for arteriovenous fistula creation but the evidence for these recommendations is limited. We compared vascular access outcomes of fistulas created in agreement with the ESVS Clinical Practice Guidelines (i.e. arteries and veins >2 mm for forearm fistulas and >3 mm for upper arm fistulas) with fistulas created outside these recommendations. METHODS: The multicenter Shunt Simulation Study cohort contains 211 hemodialysis patients who received a first radiocephalic, brachiocephalic, or brachiobasilic fistula before publication of the ESVS Clinical Practice Guidelines. All patients had preoperative duplex ultrasound measurements according to a standardized protocol. Outcomes included duplex ultrasound findings at 6 weeks after surgery, vascular access function, and intervention rates until 1 year after surgery. RESULTS: In 55% of patients, fistulas were created in agreement with the ESVS Clinical Practice Guidelines recommendations on minimal blood vessel diameters. Concordance with the guideline recommendations was more frequent for forearm fistulas than for upper arm fistulas (65% vs 46%, p = 0.01). In the entire cohort, agreement with the guideline recommendations was not associated with an increased proportion of functional vascular accesses (70% vs 66% for fistulas created within and outside guideline recommendations, respectively; p = 0.61) or with decreased access-related intervention rates (1.45 vs 1.68 per patient-year, p = 0.20). In forearm fistulas, however, only 52% of arteriovenous fistulas created outside these recommendations developed into a timely functional vascular access. CONCLUSIONS: Whereas upper arm arteriovenous fistulas with preoperative blood vessel diameters <3 mm had similar vascular access function as fistulas created with larger blood vessels, forearm arteriovenous fistulas with preoperative blood vessel diameters <2 mm had poor clinical outcomes. These results support that clinical decision-making should be guided by an individual approach.

Fatal sepsis with peripheral necrosis due to Capnocytophagus canimorsus infection after dog bite: a case report.

Capnocytophaga canimorsus is a commensal bacterium in dogs and cats' saliva that can be transmitted to humans by licking, biting, or scratching. Although rare, an infection with C. canimorsus can have lethal consequences. Based on this case, the authors want to emphasize the importance of adequate wound care, close monitoring, and the use of prophylactic antibiotics after a dog bite or cat bite. Case Presentation: The authors present the case of a healthy 52-year-old patient with severe sepsis, disseminated intravascular coagulation, multiorgan failure, and peripheral necrosis of the lower arms, lower legs, nose, and genitals due to an infection with C. canimorsus after a dog bite. The patient eventually died on the ICU. Clinical Discussion: Due to the severeness of the sepsis, the patient was admitted to the ICU for maximum supportive care. As a last resort to save his life, an amputation of his nose, genitals, lower arms, and a transtibial amputation was proposed. In good consultation with the family, the decision was made not to perform this very mutilating surgery. The therapy was stopped because the loss in quality of life was too severe to justify continuation. The patient died soon after stopping supportive therapy. Conclusion: Based on this case, the authors would like to point out that, although rare, an infection with C. canimorsus can have devastating consequences with a high mortality and morbidity rate. It is important to know about this complication and to be aware of the importance of adequate wound care, close monitoring, and the use of prophylactic antibiotics after a dog bite or cat bite.

Editor's Choice - Interventions to Achieve Functionality in Newly Created Arteriovenous Fistulas in the Shunt Simulation Study Cohort.

OBJECTIVE: Although observational cohort studies report that interventions to achieve functionality are clinically successful in 85% of patients, the proportion of newly created autologous arteriovenous fistulas that result in functional vascular access typically is only 70 - 80%. To address this discrepancy, the selection and outcomes of interventions to achieve functionality in a multicentre prospective cohort study were analysed. METHODS: The Shunt Simulation Study enrolled 222 patients who needed a first arteriovenous fistula in nine dialysis units in The Netherlands from 2015 to 2018 and followed these patients until one year after access creation. In this observational study, the technical and clinical success rates of interventions to achieve functionality based on lesion and intervention characteristics were analysed and the clinical outcomes of arteriovenous fistulas with assisted and unassisted functionality were compared. RESULTS: For patients who were on dialysis treatment at the end of the study, unassisted fistula functionality was 54% and overall fistula functionality was 78%. Thirty-four per cent of arteriovenous fistulas required an intervention to achieve functionality, 68% of which eventually became functional. Seventy-five per cent of these interventions were percutaneous balloon angioplasties of vascular access stenoses. Patients with clinically successful interventions to achieve functionality had larger pre-operative vein diameters (2.8 ± 1.0 mm vs. 2.3 ± 0.6 mm, p = .036) and less often presented with thrombosed fistulas than patients with unsuccessful interventions (7% vs. 43%, p = .006). Arteriovenous fistulas with assisted functionality had similar secondary patency as fistulas with unassisted functionality (100% and 98% at six months, p = .44), although they required more interventions to maintain function (2.6 vs. 1.7 per year; rate ratio 1.52, 95% CI 1.04 - 2.18, p = .032). CONCLUSION: Interventions to achieve functionality were needed in about a third of newly created arteriovenous fistulas. Most thrombosed fistulas were abandoned, and when selected for thrombectomy rarely reached clinical success. On the other hand, interventions to achieve functionality of patent fistulas had high clinical success rates and therefore can be done repeatedly until the fistula has become functional.

Treatment of Aortoiliac Aneurysms: Compatibility of the E-liac Stent Graft (Artivion®, Iliac Branch Device) with Endurant II or IIs (Medtronic®, EVAR).

PURPOSE: Iliac branch devices (IBD) are widely used to treat aortoiliac aneurysms with an unfit distal landing zone for standard endovascular aneurysm repair (EVAR). The aim of this retrospective study was to examine the treatment of aortoiliac aneurysms with the combination of the Endurant II(s) stent graft system (Medtronic®) and the E-liac stent graft (Artivion®). MATERIALS AND METHODS: Data of all patients who underwent an EVAR combined with unilateral or bilateral IBD between January 2015 and January 2020 were analyzed. Primary outcomes were technical success at implantation (successful EVAR with IBD extension placement and patency of the grafts without type 1 or type 3 endoleak), and type 1b/3 endoleak, hypogastric artery patency and IBD-related reinterventions during follow-up. Secondary outcomes were all type 1 endoleak, all reinterventions, rupture, and mortality during follow-up. RESULTS: A total of 38 patients were treated with a combination of EVAR with IBD. Technical success was 94.7% (n = 36/38). The 30-day survival was 100%. Median follow-up time was 31 months (range 8-56). During follow-up, no patients developed type 1b or type 3 endoleak and all hypogastric arteries at the side of IBD remained patent. The overall reintervention rate at 12 months follow-up was 5.3% (n = 2/38) and the IBD-related reintervention rate was 2.6% (n = 1/38). CONCLUSION: The combination of the Endurant II(s) and the E-liac stent graft system is an effective and safe procedure for patients with an aortoiliac aneurysm. We confirm the high hypogastric artery patency rate using IBD. Furthermore, these devices have a high technical success rate even when it is combined with an Endurant II(s) EVAR main body.

An adapted protocol for magnetic localisation of nonpalpable breast cancer lesions and sentinel lymph nodes using a magnetic seed and superparamagnetic iron oxide tracer.

BACKGROUND: Localisation techniques for nonpalpable breast cancer lesions and sentinel lymph node biopsy (SLNB) are associated with several drawbacks. A complete magnetic technique using magnetic seeds and superparamagnetic iron oxide tracer could be an interesting alternative. This study describes a clear protocol and the results of a combined magnetic approach. METHODS: From August 2021 to February 2022 40 patients undergoing breast conserving surgery with SLNB were eligible for inclusion. Localisation was performed under ultrasound or stereotactic guidance, 1 week before surgery. Subsequently, 1 ml of tracer was injected at least 4 cm away from the tumour. Technetium-99m (99m Tc) was injected 1 day before surgery as control procedure. Outcomes were SLNB time, a number of nodes detected with magnetic tracer including comparison with 99m Tc, a success rate of malignant lesion detection and pathological margin assessment. RESULTS: In total, 40 procedures were performed on 39 patients. A median of one node was retrieved. Sentinel nodes were retrieved using MagTrace® with a 92.5% detection rate compared to 99m Tc. Wide local excision under magnetic guidance was successful in 35 cases. CONCLUSIONS: This paper describes a combined magnetic approach for breast-conserving surgery and SLNB. An adapted protocol is described and could be used for implementation.

Pre-operative Patient Specific Flow Predictions to Improve Haemodialysis Arteriovenous Fistula Maturation (Shunt Simulation Study): A Randomised Controlled Trial.

OBJECTIVE: An arteriovenous fistula (AVF) needs to mature before it becomes suitable to cannulate for haemodialysis treatment. Maturation importantly depends on the post-operative flow increase. Unfortunately, 20-40% of AVFs fail to mature (FTM). A patient specific computational model that predicts immediate post-operative flow was developed, and it was hypothesised that providing information from this model for planning of fistula creation might reduce FTM rates. METHODS: A multicentre, randomised controlled trial in nine Dutch hospitals was conducted in which patients with renal failure who were referred for AVF creation, were recruited. Patients were randomly assigned (1:1) to the control or computer simulation group. Both groups underwent a work up, with physical and duplex ultrasonography (DUS) examination. In the simulation group the data from the DUS examination were used for model simulations, and based on the immediate post-operative flow prediction, the ideal AVF configuration was recommended. The primary endpoint was AVF maturation defined as an AVF flow ≥500 mL/min and a vein inner diameter of ≥4 mm six weeks post-operatively. The secondary endpoint was model performance (i.e. comparisons between measured and predicted flows, and (multivariable) regression analysis for maturation probability with accompanying area under the receiver operator characteristic curve [AUC]). RESULTS: A total of 236 patients were randomly assigned (116 in the control and 120 in the simulation group), of whom 205 (100 and 105 respectively) were analysed for the primary endpoint. There was no difference in FTM rates between the groups (29% and 32% respectively). Immediate post-operative flow prediction had an OR of 1.15 (1.06-1.26; p < .001) per 100 mL/min for maturation, and the accompanying AUC was 0.67 (0.59-0.75). CONCLUSION: Providing pre-operative patient specific flow simulations during surgical planning does not result in improved maturation rates. Further study is needed to improve the predictive power of these simulations in order to render the computational model an adjunct to surgical planning.

Gentamicin Containing Collagen Implants and Groin Wound Infections in Vascular Surgery: A Prospective Randomised Controlled Multicentre Trial.

OBJECTIVE: The aim of this study was to assess the effectiveness of gentamicin containing collagen implants in the reduction of surgical site infections (SSIs) in patients undergoing an inguinal incision for vascular surgery. METHODS: Prospective blinded randomised controlled multicentre trial (RCT), performed in four hospitals in The Netherlands and Belgium. This study included 288 patients who underwent an inguinal incision for primary arterial repair (femoral endarterectomy, femorofemoral or femoropopliteal bypass, aortobifemoral bypass, thrombectomy, embolectomy, endovascular aneurysm repair) between October 2012 and December 2015. Patients were randomised to receive a gentamicin implant (study group) or no implant (control group). The calculated sample sizes of 304 patients per group were not reached. Primary outcome was SSI incidence after six weeks. Secondary outcomes were time to onset of infection, length of hospital stay, allergic reactions, treatment with antibiotics, need for re-admission, re-operation and mortality. RESULTS: One hundred fifty-one patients were allocated to the study group (mean age 69 ± 9.2 years) and 137 patients were allocated to the control group (mean age 70 ± 10.4 years). Both groups were homogeneous regarding baseline and intra-operative characteristics. Gentamicin implants did not result in a significant overall reduction of SSIs in the study group (7% vs. 12%, p = .17). In a post hoc analysis comparing two study sites with low (<10%) and two study sites with high (>10%) infection rates in the control group, gentamicin implants significantly reduced SSIs in high risk centres (22% vs. 1%, p < .001), whereas there was no significant effect in low risk centres (13% vs. 7%, p = .30). There were no allergic reactions and all secondary outcomes were comparable between groups. CONCLUSION: Gentamicin implants did not result in a significant overall reduction of SSIs in this RCT. Gentamicin implants did reduce the incidence of SSIs in high risk centres and may be a valuable adjunct to improve outcomes in such vascular centres with a high incidence of wound infections. However, the limitation of not reaching the calculated sample sizes should be considered.

Improvements in patient outcomes with next generation endovascular aortic repair devices in the ENGAGE Global Registry and the EVAR-1 clinical trial.

BACKGROUND: The outcomes from the randomized controlled trials (RCTs) comparing endovascular aortic aneurysm repair (EVAR) to open surgical repair (OSR) may no longer be reflective of currently technology. Here the EVAR-1 trial and the ENGAGE registry are examined to assess potential improvements in outcomes with modern stent graft systems. METHODS: EVAR-1 was a multicenter, prospective, randomized controlled trial in the UK and patients were enrolled between 1999 and 2004 and treated with first- and second-generation devices. ENGAGE is an observational, nonrandomized, prospective registry that completed enrollment between 2009 and 2011. All ENGAGE patients were treated with the Endurant AAA Stent Graft System. A descriptive comparison of the published four-year outcomes of all-cause mortality (ACM), aneurysm-related mortality (ARM), rupture after elective EVAR, and reinterventions are reported. RESULTS: Through the four-year timepoint, freedom from ACM was 74.4% in the EVAR-1 Trial and 74.6% in the ENGAGE registry. ARM in the EVAR-1 trial was 4.2% and in the ENGAGE registry was 1.9%. Death due to rupture through four years was 1.6% (10/626) and 0.5% (6/1263) in the EVAR-1 and ENGAGE patients, respectively. In the EVAR-1 trial, the proportion of patients requiring at least one reintervention through the four-year timepoint was 19.3% (121/626) whereas in the ENGAGE registry, reinterventions occurred in 10.9% (138/1263) of patients. CONCLUSIONS: EVAR patient outcomes have improved since the time of the original EVAR vs. OSR trials and data from real-world registries should be considered a primary resource for developing new guidelines for patient selection and management.

Editor's Choice - Five Year Outcomes of the Endurant Stent Graft for Endovascular Abdominal Aortic Aneurysm Repair in the ENGAGE Registry.

OBJECTIVE/BACKGROUND: Endovascular abdominal aortic aneurysm repair (EVAR) is commonly used to treat abdominal aortic aneurysm (AAA). However, the incidence of long-term complications and the need for re-interventions after EVAR remain a concern. Newer generation stent grafts have encouraging short and mid-term outcomes, but thorough analysis of their long-term performance is necessary. METHODS: The ENGAGE registry includes a total of 1263 patients with AAA enrolled from March 2009 to April 2011 at 79 centres across 30 countries. The aim of this study is to present standard EVAR outcomes in the registry after five years. RESULTS: A significant proportion of the ENGAGE patients presented with challenging features, such as 15.2% with an AAA diameter >7 cm, 12.0% with proximal neck lengths <15 mm, and 10.2% with infrarenal neck angles >60°. Of the 1263 enrolled subjects, 17.8% were implanted outside of the instructions for use for the device. At the five year follow up, the Kaplan-Meier overall survival rate was 67.4% and the freedom from aneurysm related mortality was 97.8%. Freedom from aneurysm rupture, secondary procedures, and conversion to open repair at five years were 98.6%, 84.3%, and 97.9% respectively. The five year freedom from type IA endoleaks was 95.2% and for type III endoleaks 97.4%. Aneurysm sac diameter at five years was observed to have either decreased ≥5 mm in diameter or remained stable in 89.4% of the patients. CONCLUSION: Five year follow up of patients in the ENGAGE registry demonstrates sustained safety, effectiveness, and durability in an international cohort that is reflective of real world experience. Additional follow up is expected through to 10 years.

Duplex-guided versus Conventional Percutaneous Transluminal Angioplasty of Iliac TASC II A and B Lesion: A Randomized Controlled Trial.

BACKGROUND: Percutaneous transluminal angioplasty (PTA) requires the use of nephrotoxic contrast. Patients with chronic kidney disease are more prone to develop contrast-induced nephropathy after utilization of contrast. Doppler ultrasound (duplex)-guided PTA (DuPTA) is a novel technique and has recently proven to be a successful alternative to conventional PTA in the treatment of iliac stenotic disease, without the use of contrast. In this randomized controlled trial, we evaluated whether DuPTA is as effective as conventional PTA in the treatment of iliac arterial stenotic disease. METHODS: From June 2013 till January 2017, 142 patients with symptomatic peripheral arterial disease (PAD), with significant (>70%) iliac stenotic lesions (both isolated and patients with multilevel disease without treatment of other lesions), were randomized to receive either conventional PTA or DuPTA of the iliac lesion, regardless of renal function. All patients received an ankle-brachial index, arterial mapping with duplex, and magnetic resonance angiography in the pre-operative work-up. Primary end point was procedural success, defined as passing the guidewire through the stenotic lesion and performing a PTA, with or without stenting. Reduction in peak systolic velocity (PSV) of ≥50% after successful PTA was required in the DuPTA group. Angiographic reduction of more than 50% was required in the interventional group. Decrease in PSV was evaluated in both groups 4 weeks post-procedure. RESULTS: Passing of the guidewire through the stenotic lesion was achieved in 96.5% of the DuPTA group and 98.8% of the PTA group (P = 0.34). Although PSV decreased significantly in both groups 4 weeks post-operative, PSV reduction ≥50% was significantly higher in the DuPTA group, respectively 78% vs. 58% in the PTA group (P < 0.01). The utilization of stents was significantly greater in the DuPTA group (52% vs. 18%, P < 0.01). After correction of potential confounders, significant difference in ≥50% PSV reduction remained; technical success did not differ significantly. CONCLUSIONS: DuPTA is a feasible alternative to conventional PTA in the treatment of PAD on the iliac anatomic level. Duplex examination before removal of the guidewire is recommended to evaluate adequate decrease in PSV and identify potential recoil.

Prevention of postcontrast acute kidney injury after percutaneous transluminal angioplasty by inducing RenalGuard controlled furosemide forced diuresis with matched hydration: study protocol for a randomised controlled trial.

INTRODUCTION: Percutaneous transluminal angioplasty (PTA) is often complicated due to postcontrast acute kidney injury (PC-AKI) in patients diagnosed with chronic kidney disease (CKD). Hydration therapy is the cornerstone in the prevention of PC-AKI. Furosemide forced diuresis with matched hydration using the RenalGuard system enables a steady balance between diuresis and hydration. A randomised controlled trial will be performed in order to investigate whether furosemide forced diuresis with matched hydration in combination with the RenalGuard system decreases incidence of PC-AKI in patients with CKD receiving a PTA of the lower extremities. Furthermore, we will investigate whether sampling of urine biomarkers 4 hours after intervention can detect PC-AKI in an earlier stage compared with the golden standard, serum creatinine 48-72 hours postintervention. METHODS AND ANALYSIS: A single-centre randomised controlled trial will be conducted. Patients >18 years in need of a PTA of the lower extremities and diagnosed with CKD will be randomly assigned to receive either standard of care prehydration and posthydration or furosemide forced diuresis with matched hydration periprocedural using the RenalGuard system. Four hours postintervention, a urine sample will be collected of all participating patients. Serum creatinine will be sampled within 10 days prior to intervention as well as 1, 3 and 30 days postintervention. The primary endpoint is incidence of PC-AKI post-PTA. Secondary endpoint is the rise of urine biomarkers 4 hours postintervention. ETHICS AND DISSEMINATION: Study protocol is approved by the research ethics committee and institutional review board (reference number 16 T-201 and NL59809.096.16). Study results will be disseminated by oral presentation at conferences and will be submitted to a peer-reviewed journal. It is anticipated that study results will offer a solution to contrast-induced nephropathy in patients with CKD receiving a PTA of the lower extremities. TRIAL REGISTRATION NUMBER: NTR6236; Pre-results. EUDRACT NUMBER: 2016-005072-10.

Severe Abdominal Complaints after Technical Successful Endovascular Treatment of Chronic Splanchnic Ischemia.

Reperfusion syndrome (RS) after revascularization of an arterial occlusion of the lower leg is a well-known complication. RS after splanchnic revascularization, however, is an infrequent and less-known phenomenon. We present a patient with persisting abdominal complaints after revascularization of the celiac trunk and superior mesenteric artery suggesting reocclusion. Although computed tomography angiography showed patent splanchnic arteries, an impressive hyperperfusion state of liver and spleen was visualized. Complaints diminished steadily with conservative therapy, but RS can cause severe complications such as liver failure and multiple organ failure. Ignorance of RS might interfere with adequate treatment and can contribute to a high in-hospital mortality rate.

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

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