Endovascular Repair of Juxtarenal and Pararenal Abdominal Aortic Aneurysms Using a Novel Low-Profile Fenestrated Custom-Made Endograft: Technical Details and Short-Term Outcomes.

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.

[Peripheral artery disease and diabetes: complex multidisciplinary care for an increasing number of patients]. / Perifeer arterieel vaatlijden bij diabetes.

The forthcoming increase in the number of people with diabetes mellitus (DM) is likely to lead to an absolute and relative increase in the number of people with a combination of DM and peripheral artery disease (PAD). Due to different pathophysiological processes and presentation, diagnosis and treatment in these patients are more complicated compared to non-DM related PAD. Understanding the differences, pitfalls and concerns in patients with combined DM-PAD would result in better care for these patients, who are at high risk of cardiovascular comorbidities, mortality and amputation. Introduced by two case reports, we provide an overview of current guidelines, recent literature and innovations to address these critical issues.

Safety and feasibility of arterial wall targeting with robot-assisted high intensity focused ultrasound: a preclinical study.

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.

Volumetric assessment of extracranial carotid artery aneurysms.

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.

The validity and reliability of diagnosing foot ulcers and pre-ulcerative lesions in diabetes using advanced digital photography.

BACKGROUND: The goal of this study was to determine the validity and reliability of assessing the presence of plantar foot ulceration and pre-ulcerative lesions in diabetes patients from digital photographs that were produced using a new photographic foot imaging device. METHODS: In 32 diabetes patients who had a foot ulcer or were at high risk of ulceration (a total of 60 feet), high-quality photographic images of the plantar foot surface were collected. Each foot was assessed live, from photographs 2 weeks later, and again 4 weeks later for the presence of an ulcer, abundant callus, or the absence of signs. Each foot was assessed by four independently operating foot care specialists. Agreement scores were calculated using κ values (range, 0-1). Sensitivity and specificity scores were also calculated. RESULTS: Foot ulceration was cumulatively scored 59 times, callus 78 times, and absence of signs 149 times during live assessment. Agreement with photographic assessment was very good for ulcer (κ = 0.87) and absence of signs (κ = 0.83) and good for callus (κ = 0.61). Sensitivity and specificity were high for ulcer (88% and 98%, respectively), callus (69% and 89%, respectively), and absence of signs (both 90%). Intra-observer agreement between repeated photographic assessments was good to excellent for all outcomes and observers (κ between 0.70 and 1.00). Inter-observer agreement for photographic assessments was good for ulcer (κ = 0.72-0.88) and absence of signs (κ = 0.59-0.75) and moderate to good for callus (κ = 0.48-0.73). For live assessment, inter-observer agreement scores were only slightly higher. CONCLUSIONS: The data illustrate that diabetic foot ulcers and pre-ulcerative lesions can be diagnosed in a valid and reliable manner by trained professionals from digital photographs produced with the foot imaging device. This supports the intended use of the device as a telemedical monitoring tool in the home environment for early detection of diabetic foot disease and prevention of severe complications in high-risk diabetes patients.

[Photographic foot scanner for the early diagnosis of diabetic foot]. / Fotografische voetscanner voor vroege diagnostiek diabetische voet.

Early recognition of foot ulcers and pre-ulcerative lesions in diabetic patients is important for the prevention of severe complications such as infection and amputation. The photographic foot-imaging device is a new technique intended as a home-monitoring system for the early diagnosis of signs of diabetic foot disease. The patient regularly takes pictures of the plantar foot surface which a trained healthcare professional remotely assesses. In the case of diagnosed foot problems, the patient is referred for treatment. This telemedical approach is primarily intended for patients who have previously had a foot ulcer or amputation. In particular, patients who are limited in inspecting their own feet may profit from this approach. The diagnosis of foot problems from photographs produced by the system has been proven to be both valid and reliable. If future studies demonstrate the efficacy and cost-effectiveness of this approach in preventing severe foot complications, it may become an integral part of foot care for high-risk diabetic patients.

Assessment of foot disease in the home environment of diabetic patients using a new photographic foot imaging device.

The objective of this study was to compare live and photographic assessments of clinical signs of diabetic foot disease using a new photographic foot imaging device. High quality colour photographs of the plantar foot surface were collected in 20 diabetic feet using a prototype device and in 19 diabetic feet using a definitive version of the device with optimized illumination settings. All photographs were assessed independently by four observers for presence of ulceration, abundant callus, or absence of signs and compared with live and repeated photographic assessments of the feet by the same observers. Agreement between assessments was moderate to good for all outcomes using the prototype device (56-92%) and improved using the definitive version of the device (74-100%). The data seem to suggest that important signs of diabetic foot disease can be diagnosed from high quality photographs using the photographic foot imaging device. Intended for use as telemedical monitoring device in the patients' home, frequent remote assessments may potentially contribute to the early recognition and treatment of foot disease, which may prevent further complications.

Inguinal hernia treatment with the Prolene Hernia System in a Dutch regional training hospital.

INTRODUCTION: In this retrospective study results from inguinal hernia repair with the Prolene Hernia System (PHS) in a regional training hospital were analysed. PATIENTS AND METHODS: One-hundred and seventy-eight primary inguinal hernias and thirty-nine recurrent hernias (initial non-mesh repair) were treated with the PHS. The primary endpoint was the recurrence rate. Secondary endpoints were short-term and long-term complications. Pain was evaluated by use of a visual analog scale (VAS, 0-100), and a short-form 36-item questionnaire was used to assess postoperation quality of life. All patients visited the outpatient clinic for a physical examination (100% follow-up). RESULTS: After a median follow-up of 32 months four patients were diagnosed with recurrent herniation (1.8%), three after primary hernia repair (1.6%) and one after recurrent hernia repair (2.6%). Three superficial wound infections (1.3%), three haematomas needing surgical evacuation (1.3%), and two lesions of the spermatic cord (0.9%) were diagnosed. Seven patients (3.2%) suffered from persistent pain (VAS > 40). Average VAS score was 13 (0-80) >24 months after surgery. CONCLUSION: In a regional training hospital, primary and recurrent inguinal hernias were treated with low recurrence and few complications by use of the PHS.