Matthieu Arsicot

The increasing age of patients with end-stage renal disease raises the issue of hostile arterial access for transplantation, with technical difficulties associated with clamping and suturing the iliac artery. Some of these patients - who theoretically represent those who would benefit the most from transplantation in terms of mortality - are contraindicated because of anatomical and medical issues. In this context, a specific endovascular device called EndoPreKiT (Endovascular Preparation for Kidney Transplantation) has been designed, enabling arterial access for transplantation via a mini-invasive procedure. It consists of a woven Dacron supported by self-expanding nitinol rings, ensuring anchorage and allowing arterial clamping. The middle part of the anterior face of the device is stentless, enabling the anastomosis directly onto the Dacron once the calcified artery wall has been removed. After a cadaveric study validating its technical feasibility, such device was successfully implanted in 10 patients considered unfit for transplantation due to severe wall calcification. Two of them have been successfully transplanted with excellent outcomes after 13 and 3 months of follow-up. EndoPreKiT device may be a significant breakthrough in transplant surgery, that could expand the horizon of eligibility to include even the most fragile patients with challenging arterial access.

Background: Carotid atherosclerotic plaques remain silent until their rupture, which may lead to detrimental ischemic events such as strokes. This is due, in part, to intraplaque hemorrhages (IPH) and the resulting inflammatory processes, which may promote carotid plaque vulnerability. Currently, the benefits of carotid endarterectomy remain unclear for asymptomatic patients. Interestingly, the completion of physical activity (PA) may have beneficial effects; however, the paucity of current data warrants robust longitudinal interventions. We therefore aim to study the effects of a 6-month longitudinal personalized home-based PA program on IPH, biological, and inflammatory markers in asymptomatic stroke patients. Methods: Eighty patients (≥ 18 years old) will be recruited for the Physical Activity and Carotid Atherosclerotic Plaque Hemorrhage (PACAPh) clinical trial from the Hospices Civils de Lyon. Patients will be eligible if they present with carotid stenosis ≥ 50% and are asymptomatic from any ischemic events for at least 6 months. Recruited patients will be randomized into either a PA or a control group, and assessed at baseline and after 6 months. At both time points, all patients will be assessed using magnetic resonance imaging to assess IPH, blood sampling to measure inflammatory markers and monocytic phenotyping, PA and sedentary behavior questionnaires, 6-min walking test, and maximal isometric quadricep contraction test. The randomized PA intervention will consist of reaching a daily walking step goal individually tailored to each patient. Steps will be collected using a wirelessly connected wristband. The number of steps completed by individuals in the PA group will be re-evaluated bimonthly to encourage walking habits. Discussion: The PACAPh study is the first of its kind representing a feasible, easily accessible therapeutic strategy for asymptomatic stroke patients. We hypothesize that the personalized home-based PA program will reduce IPH and modulate inflammatory and biological parameters in patients presenting with carotid plaques. If the results of the PACAPh study prove to be beneficial on such health parameters, the implementation of such kind of intervention in the daily treatment of these patients would be an advantageous and cost-effective practice to adopt globally. Trial registration: This study has been approved by the National Ethics Committee (IDRCB:2019-A01543-54/SI:19.06.21.40640). ClinicalTrials.gov NCT04053166