One-Year Analysis of Autologous Peripheral Blood Mononuclear Cells as Adjuvant Therapy in Treatment of Diabetic Revascularizable Patients Affected by Chronic Limb-Threatening Ischemia: Real-World Data from Italian Registry ROTARI.

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.

Fully Ultrasound-Assisted Endovascular Aneurysm Repair: Preliminary Report.

BACKGROUND: Reducing fluoroscopy times and iodine contrast administration during endovascular repair (EVAR) of infrarenal aortic aneurysms remains a challenge. The purpose of this study is to evaluate the preliminary results of a fully ultrasound-assisted EVAR without iodine contrast administration. METHODS: Twenty-seven consecutive patients underwent an elective intravascular ultrasound (IVUS)-assisted EVAR with final contrast-enhanced ultrasound (CEUS) control of correct aneurysm exclusion. In no case intraprocedural injection of iodine contrast medium was performed. The primary study's end points were the overall duration of the procedure, duration of fluoroscopy, cumulative radiation dose, the length of intraoperative CEUS control, and the comparison of findings between intraoperative CEUS and computed tomography (CT) scan at 1 month. RESULTS: Mean duration of the procedure was 130 ± 35 min. Overall duration of fluoroscopy was 22 ± 18 min. Mean radiation dose was 66 mGy (range 24-82). The mean length of CEUS final control was 8 ± 2 min. No type I or type III endoleak was detected either at CEUS or at angio-CT scan at 1 month from EVAR. CEUS revealed a type II endoleak in 6 patients (22%), compared to 9 type II endoleaks (33%) detected at angio-CT scan 1 month after the procedure (P = 0.5). CONCLUSIONS: Fully ultrasound (IVUS and CEUS)-assisted EVAR is safe, feasible, and reliable, completely eliminating the need for iodine contrast medium and reducing the radiation exposure for both patients and surgeons.

1-Year Results From a Prospective Experience on CAS Using the CGuard Stent System: The IRONGUARD 2 Study.

OBJECTIVES: The aim of this study was to evaluate the 1-year safety and efficacy of a dual-layered stent (DLS) for carotid artery stenting (CAS) in a multicenter registry. BACKGROUND: DLS have been proved to be safe and efficient during short-term follow-up. Recent data have raised the concern that the benefit of CAS performed with using a DLS may be hampered by a higher restenosis rate at 1 year. METHODS: From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system at 20 centers. The primary endpoint was the occurrence of death and stroke at 1 year. Secondary endpoints were 1-year rates of transient ischemic attack, acute myocardial infarction, internal carotid artery (ICA) restenosis, in-stent thrombosis, and external carotid artery occlusion. RESULTS: At 1 year, follow-up was available in 726 patients (99.04%). Beyond 30 days postprocedure, 1 minor stroke (0.13%), four transient ischemic attacks (0.55%), 2 fatal acute myocardial infarctions (0.27%), and 6 noncardiac deaths (1.10%) occurred. On duplex ultrasound examination, ICA restenosis was found in 6 patients (0.82%): 2 total occlusions and 4 in-stent restenoses. No predictors of target ICA restenosis and/or occlusion could be detected, and dual-antiplatelet therapy duration (90 days vs 30 days) was not found to be related to major adverse cardiovascular event or restenosis occurrence. CONCLUSIONS: This real-world registry suggests that DLS use in clinical practice is safe and associated with minimal occurrence of adverse neurologic events up to 12-month follow-up.

Autologous cell therapy in diabetes­associated critical limb ischemia: From basic studies to clinical outcomes (Review).

Cell therapy is becoming an attractive alternative for the treatment of patients with no­option 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 non­healing cutaneous trophic lesions. In the present review, the current state of the art of strategies in the cell therapy field are summarized, focusing on intra­operative 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.

Use of a Novel Device in Reconstructive Venous Surgery: Preliminary Results.

Evaluation of the outcomes of OSES (oval-shaped external support), a novel device for external valvuloplasty of the great saphenous vein (GSV) for the conservative treatment of superficial venous insufficiency. Between 2012 and 2015, 30 patients underwent external valvuloplasty of the GSV for a total of 32 limbs. Patients were subjected to clinical and instrumental follow-up by a half-year ultrasound for a minimum of 36 months. The main endpoints were the recurrence of varicose disease, persistent or recurrent venous reflux, and venous thrombosis. Varicose recurrence was verified in six limbs on 32 (18.75%). Four limbs (12.5%) presented a recurrence of the reflux even in the absence of varicose veins. Two limbs (6.25%) underwent saphenectomy after the valvuloplasty intervention at 12 and 18 months, respectively, because of the presence of saphenofemoral reflux and varicose recurrences. No case of venous thrombosis of the saphenous trunk was observed. The external valvuloplasty of the GSV is a well-known technique that used to treat the superficial venous insufficiency. The newly introduced OSES device seems to show better midterm results, due to a better alignment of the valve flaps. In our experience, the use of this device gives better long-term results and allowed to extend the indication to patients with saphenic diameters that were considered not eligible for repair. In conclusion, although our data needs further confirmation, OSES device might represents a new interesting opportunity for reconstructive venous surgery.

1-Month Results From a Prospective Experience on CAS Using CGuard Stent System: The IRONGUARD 2 Study.

OBJECTIVES: This study sought to evaluate 30-day safety and efficacy of dual-layer mesh-covered carotid stent systems for carotid artery stenting (CAS) in the clinical practice. BACKGROUND: When compared with carotid endarterectomy, CAS has been associated with a higher rate of post procedural neurologic events; these could be related to plaque's debris prolapsing through stent's mesh. Consequently, the need for increased plaque coverage has resulted in the development of dual-layer mesh-covered carotid stent systems. METHODS: From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system in 20 centers. The primary endpoint was stroke up to 30 days; secondary endpoints were technical and procedural success; external carotid artery occlusion; and in-hospital and 30-day transient ischemic attack (TIA), acute myocardial infarction (AMI), and death rates. RESULTS: Symptoms were present in 131 (17.87%) patients. An embolic protection device was used in 731 (99.72%) patients. Procedural success was 100%, technical success was obtained in all but 1 (99.86%) patient, who died in hospital due to a hemorrhagic stroke. Six TIAs, 2 minor strokes, and 1 AMI occurred during in-hospital stay, and external carotid artery occlusion was evident in 8 (1.09%) patients. Between hospital discharge and 30-day follow-up, 2 TIAs, 1 minor stroke, and 3 AMIs occurred. Therefore, the cumulative stroke rate was 0.54%. CONCLUSIONS: This real-world registry suggests that use of CGuard embolic prevention system in clinical practice is safe and associated with a minimal occurrence of adverse neurological events up to 30-day follow-up.

Peroperative Intravascular Ultrasound for Endovascular Aneurysm Repair versus Peroperative Angiography: A Pilot Study in Fit Patients with Favorable Anatomy.

BACKGROUND: The aim of this study was to compare intravascular ultrasound (IVUS) assistance for endovascular aortic aneurysm repair (EVAR) to standard assistance by angiography. METHODS: From June 2015 to June 2017, 173 consecutive patients underwent EVAR. In this group, 69 procedures were IVUS-assisted with X-ray exposure limited to completion angiography for safety purposes because an IVUS probe does not yet incorporate a duplex probe (group A), and 104 were angiography-assisted procedures (group B). All IVUS-assisted procedures were performed by vascular surgeons with basic duplex ultrasound (DUS) training. The primary study endpoints were mean radiation dose, duration of fluoroscopy, amount of contrast media administered, procedure-related outcomes, and renal clearance expressed as the glomerular filtration rate (GFR) before and after the procedure. Secondary endpoints were operative mortality, morbidity, and arterial access complications. RESULTS: Mean duration of fluoroscopy time was significantly lower for IVUS-assisted procedures (24 ± 15 min vs. 40 ± 30 min for angiography-assisted procedures, P < 0.01). Moreover, mean radiation dose (Air KERMA) was significantly lower in IVUS-assisted procedures (76m Gy [44-102] vs. 131 mGy [58-494]), P < 0.01. IVUS-assisted procedures required fewer contrast media than standard angiography-assisted procedures (60 ± 20 mL vs. 120 ± 40 mL, P < 0.01). The mean duration of the procedure was comparable in the two groups (120 ± 30 min vs. 140 ± 30 min, P = 0.07). No difference in renal clearance before and after the procedure was observed in either of the two groups (99.0 ± 4/97.8 ± 2 mL/min in group A and 98.0 ± 3/97.6 ± 5 mL/min in group B) (P = 0.28). The mean length of follow-up was nine months (6-30 months). No postoperative mortality, morbidity, or arterial access complications occurred. No type 1 endoleak was observed. Early type II endoleaks were observed in 21 patients (11%), 12 in the angiography-assisted group (11%) and nine in the IVUS-assisted group (12%). They were not associated with sac enlargement ≥5 mm diameter and therefore did not require any additional treatment. CONCLUSIONS: Compared with standard angiography-assisted EVAR, IVUS significantly reduces renal load with contrast media, fluoroscopy time, and radiation dose while preserving endograft deployment efficiency. Confirmation from a large prospective study with improved IVUS probes will be required before IVUS-assisted EVAR alone can become standard practice.

[Cholelithiasis and renal cysts: simultaneous laparoscopic treatment]. / Litiasi della colecisti e cisti renali: trattamento laparoscopico in un unico tempo.

Laparoscopic surgery has been increasingly used in different fields of surgery. This report concerns the authors' experience with combined laparoscopic cholecystectomy and symptomatic renal cyst decortication. The mean diameter of the cysts was 11.2 cm. and involved the left and right kidney in 3 and 1 patient, respectively. All cysts were peripheral. Surgery was performed using 4 trocars in 3 cases and 5 trocars in the other. The mean operative time was 110 minutes and mean blood loss 40 cc. Postoperative pain was minimal. The mean duration of postoperative ileus was 2.2 days. No significant complications were observed. The mean postoperative hospital stay was 3.5 days. At follow-up examinations all patients were pain-free. Recurrence of the cyst was observed in only one case. Combined laparoscopic cholecystectomy and renal cyst decortication is technically feasible in selected cases and does not seem to significantly affect the perioperative course of cholecystectomy.

[Cavernous hemangioma of the adrenal glands: a clinical case]. / Emangioma cavernoso del surrene: caso clinico.

Cavernous haemangiomas of the adrenal gland are rare and the preoperative diagnosis is very difficult. We report the case of a patient admitted for aspecific abdominal pain. Instrumental diagnostic investigations (ultrasonography and CT scan) revealed an adrenal mass of uncertain interpretation which was surgically removed and histologically diagnosed as a cavernous haemangioma.