Cell therapy is becoming an attractive alternative for the treatment of patients with no‑option critical limb ischemia (CLI). The main benefits of cell therapy are the induction of therapeutic angiogenesis and neovascularization that lead to an increase in blood flow in the ischemic limb and tissue regeneration in non‑healing cutaneous trophic lesions. In the present review, the current state of the art of strategies in the cell therapy field are summarized, focusing on intra‑operative autologous cell concentrates in diabetic patients with CLI, examining different sources of cell concentrates and their mechanisms of action. The present study underlined the detrimental effects of the diabetic condition on different sources of autologous cells used in cell therapy, and also in delaying wound healing capacity. Moreover, relevant clinical trials and critical issues arising from cell therapy trials are discussed. Finally, the new concept of cell therapy as an adjuvant therapy to increase wound healing in revascularized diabetic patients is introduced.
Aim: To assess the medium and long-term performance of the Endurant stent graft in a cohort of consecutive patients treated with this device for an abdominal aortic aneurysm (AAA) both inside and outside of the instructions for use (IFU) and to find factors influencing the outcomes. Methods: Our observational, retrospective, single-center study included all patients who consecutively underwent endovascular aneurysm repair with the Endurant stent graft from February 2009 to January 2023. Patients with an AAA to treat according to current guidelines were included. Patients were divided into two groups: Group 1 inside of the IFUs and Group 2 outside of the IFUs for the proximal aortic neck. Patients were followed up after the procedure with computed angiography tomography, ultrasound examination, and interviews. Aneurysm-related mortality, procedure-related reinterventions, and type IA and III endoleaks were considered primary endpoints. Secondary endpoints included aneurysmal sac variations and graft thrombosis. Results: A total of 795 patients were included, 650 in Group 1 and 145 in Group 2; 732 were males, and the mean age was 74 ± 8. Anamnestic baseline did not differ between the two groups. Neck length, width, and angulation were different between the two groups (all p < 0.001). A total of 40 patients had a ruptured AAA, while 56 were symptomatic. At a mean follow-up of 43 ± 39 months, aneurysm-related mortality was less than 1%, and 82 endoleak (10.5%) were observed. Overall endoleak rate and type 1A endoleak, as well as procedure-related reintervention, were significantly more frequent in Group 2. Sac regression of at least 5 mm was observed in 65.9% of cases. AAAs larger than 60.5 mm carried a higher risk of endoleak (HR: 1.025; 95% CI: 1.013–1.37; p < 0.001) and proximal necks shorter than 13.5 mm carried a higher type 1A risk (HR: 0.890; 95% CI: 0.836–0.948; p < 0.001). Patients without chronic obstructive pulmonary disease and taking lipid-lowering drugs had an overall more consistent sac-shrinking rate. Conclusions: The Endurant stent graft proves safe and reliable. Out-of-IFU treatment has poorer medium and long-term outcomes. Some conditions influence medium and long-term reintervention risk and sac behavior. Patients with bigger aneurysms, proximal necks shorter than 13.5 mm, and chronic obstructive pulmonary disease should be more carefully evaluated during follow-up. Consistent follow-up is in keeping low aneurysm-related mortality. Personalized risk profiles and peri and postoperative management strategies are needed.
Background: Endovascular aneurysm repair (EVAR) is the preferred treatment for abdominal aortic aneurysms (AAAs). This study evaluated the differences between the anticipated and actual achieved proximal sealing zones for standard EVAR endografts and their potential implications in a real-world AAA population. Methods: Data from 275 consecutive EVAR patients treated with the Endurant endograft (Medtronic, Minneapolis, MN, USA) between 2009 and 2022 were retrospectively analyzed. The proximal sealing zone was calculated preoperatively (target anticipated sealing zone, TASZ) and postoperatively (real achieved sealing zone, RASZ) from computed tomography angiography (CTA) images. These metrics were evaluated by assuming that they had a truncated cone shape, calculating the cone’s lateral surface by measuring the proximal and distal centerline areas and the distance between the planes. The primary outcome was the occurrence of type 1A endoleak at the longest available follow-up. Results: RASZ was significantly smaller and shorter than TASZ (p = 0.001), with an average area reduction of 24.5 mm2 and a median length reduction of 3 mm. Area and cranial length loss were present even when correcting for graft positioning imperfections. In the Cox proportional hazard regression model, TASZ and RASZ lengths were both independently associated with a lower risk of type 1A endoleak (HR: 0.88, 95% CI 0.80–0.96 and HR: 0.92, 95% CI 0.86–0.99, respectively). A Kaplan–Meier analysis confirmed that patients with RASZ > 5.5 mm had a survival free from endoleak higher than patients with RASZ ≤ 5.5 mm. Conclusions: In this real-world AAA population, the achieved proximal sealing zone was significantly shorter and smaller than planned, regardless of optimal endograft placement. The early calculation of RASZ, i.e., the PSZ achieved via CTA, is critical for risk stratification and follow-up.
Wounds in diabetic patients with peripheral arterial disease (PAD) may be poorly responsive to revascularization and conventional therapies. Background/Objective: This study’s objective is to analyze the results of regenerative cell therapy with peripheral blood mononuclear cells (PBMNCs) as an adjuvant to revascularization. Methods: This study is based on 168 patients treated with endovascular revascularization below the knee plus three PBMNC implants. The follow-up included clinical outcomes at 1-2-3-6 and 12 months based on amputations, wound healing, pain, and TcPO2. Results: The results at 1 year for 122 cases showed a limb rescue rate of 94.26%, a complete wound healing in 65.59% of patients, and an improvement in the wound area, significant pain relief, and increased peripheral oxygenation. In total, 64.51% of patients completely healed at 6 months, compared to the longer wound healing time reported in the literature in the same cohort of patients, suggesting that PBMNCs have an adjuvant effect in wound healing after revascularization. Conclusions: PBMNC regenerative therapy is a safe and promising treatment for diabetic PAD. In line with previous experiences, this registry shows improved healing in diabetic patients with below-the-knee arteriopathy. The findings support the use of this cell therapy and advocate for further research.