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We evaluated the outcomes of revascularization in patients with chronic limb-threatening ischemia (CLTI) treated in real-world settings. This is a prospective multicenter cohort study with 12-month follow-up enrolling patients (n = 287) with CLTI undergoing open, endovascular, or hybrid lower extremity revascularization. The primary end point was amputation-free survival (AFS) at 12 months. Cox proportional analysis was used to determine independent predictors of amputation and restenosis. At 30 days, major adverse cardiovascular and major adverse limb events (MALE) rates were 3.1% and 2.1%, respectively. At 1 year, the overall survival rate was 88.8%, the AFS was 86.6%, and the primary patency was 70.5%. Freedom from MALE was 62.5%. After multivariate analysis, smoking (hazard ratio [HR] = 2.2, P = 0.04), renal failure (HR = 2.3, P = 0.03), Rutherford class (≥5) (HR = 3.2, P = 0.01), and below-the-knee disease (HR = 2.0, P = 0.05) were significant predictors of amputation; iloprost infusion (>10 vials) (HR = 0.64, P = 0.05) was a significant protective factor. Cilostazol administration (HR = 0.77, P = 0.05) was a significant protective factor for restenosis. Results from this prospective multicenter registry offer a consistent overview of clinical outcomes of CLTI patients at 1 year when adequately revascularized. Medical treatment, including statins, cilostazol and iloprost, were associated with improved 1-year freedom from restenosis and amputation.

The aim of the present study was to investigate the early results of mechanochemical ablation (MOCA) for the treatment of small saphenous vein (SSV) incompetence.We performed a single-center, retrospective analysis of a prospectively collected database of 60 patients treated with MOCA for single-axis SSV incompetence. All procedures were performed with the patient under local anesthesia using the ClariVein catheter (Merit Medical, South Jordan, Utah) combined with 2% polidocanol and, where appropriate, additional microphlebectomy. The primary study endpoint was to assess the SSV occlusion rate at the 1-, 6-, and 12-month follow-up examinations. The secondary endpoints included the Venous Clinical Severity Score, quality of life (QoL) assessment, periprocedural pain, and further complications after the intervention and during the follow-up period. Patient QoL was assessed using the Aberdeen Varicose Vein Questionnaire. Pain was measured using a 100-mm visual analog scale.Technical success was achieved in 100% of the cases. The mean visual analog scale score on the first postoperative day was 15 mm. No major events were recorded. No neurological complications or deep vein thrombosis were observed. Minor complications included ecchymosis in 3.3% of cases (2 of 60), transient phlebitis of the SSV in 5% of cases (3 of 60), and itching in 3.3% of cases (2 of 60). At the 1-, 6-, and 12-month follow-up examinations, the occlusion rate was 100% (60 of 60), 98.3% (57 of 58), and 92.6% (50 of 54). The median Venous Clinical Severity Score had significantly decreased from 5 (interquartile range [IQR], 3-6) at baseline to 2 (IQR, 1-4) at the 1-month follow-up (P .001), 1 (IQR, 1-2) at the 6-month follow-up (P .001) and 1 (IQR, 0-1) at the 12-month follow-up (P .001). The mean Aberdeen Varicose Vein Questionnaire score had improved from the baseline score of 25 ± 14.61 to 15.81 ± 13.76 at the 1-month follow-up (P .001), to 9.81 ± 7.42 at the 6-month follow-up (P .001) and 4.73 ± 3.32 at the 12-month follow-up (P .001).The results of our study have shown that MOCA is a feasible, safe, and painless procedure for the treatment of SSV incompetence with an occlusion rate of 92.6% at the 12-month examination. No sural nerve injuries or other major complications were observed. The procedure also provided good clinical results and positive effects on patient QoL.

Purpose:To evaluate the potential anatomical feasibility of using the off-the-shelf multibranched Zenith t-Branch for the treatment of thoracoabdominal aortic aneurysms (TAAAs) in female patients.Materials and Methods:A total of 268 patients (median age 68 years; 69 women) with degenerative TAAA treated at a single institution by means of open or endovascular repair between 2007 and 2019 were retrospectively analyzed to determine the feasibility of using the Zenith t-Branch based on the manufacturer’s instructions for use. The factors determining overall anatomical feasibility were divided into vascular access, aortic anatomy, and visceral vessels. The results were stratified by sex and compared. A logistic regression model was constructed to determine any association between feasibility and clinical factors or potential confounding variables; results are expressed as the odds ratio (OR) with 95% confidence interval (CI).Results:The overall anatomical feasibility was 39% (22% women vs 45% men, p=0.001). The feasibility was negatively influenced by female sex (pConclusion:A little more than a third of an all-comers cohort of patients with degenerative TAAA could have been treated with on-label use of the Zenith t-Branch. However, only 22% of women could have been treated because of sex-related anatomical limitations. New generations of multibranched devices should address these differences.

Purpose: To describe a possible application of thoracic false lumen occlusion techniques with a Candy-Plug occluder to induce false lumen thrombosis for preconditioning the spinal cord during staged fenestrated repair of postdissecting thoracoabdominal aneurysms. Technique: A Candy-Plug occluder is deployed within the thoracic false lumen after proximal entry tear coverage with a standard thoracic stent-graft during staged repair of postdissecting thoracoabdominal aneurysms. The blockade of thoracic false lumen retrograde reperfusion from distal entry tears induces a controlled thrombosis of both the thoracic false lumen and intercostal arteries. Then, when the fenestrated device is delivered 4 to 6 weeks later, the procedure is completed with standard techniques according to the staging protocols of individual centers. Conclusion: A new possible application of a Candy-Plug false lumen occlusion technique might be an intermediate procedure aimed at preconditioning the spinal cord by occluding the thoracic false lumen during complex staged fenestrated thoracoabdominal repairs.

OBJECTIVES The aim of this study was to evaluate the proportion of thoraco-abdominal aortic aneurysms (TAAAs) that could theoretically be treated with the JOTEC® E-nside® Thoracoabdominal Branch Endoprosthesis off-the-shelf multibranched endograft. METHODS Preoperative computed tomography scans of patients with atherosclerotic TAAA treated between 2007 and 2019 were reviewed, and the anatomical feasibility of the E-nside graft was verified by a retrospective study (clinicaltrials.gov: NCT03959670) based on the investigational manufacturer instructions for use. The anatomical factors determining overall feasibility were divided into vascular access (AC) feasibility, aortic (AO) feasibility and visceral vessels (VV) feasibility. RESULTS Two hundred sixty-eight patients with thoraco-abdominal aneurysms were analysed: the overall treatment feasibility was 43%. AC feasibility was 78%, AO feasibility 60% and VV feasibility 79%. An iliac diameter CONCLUSIONS The E-nside off-the-shelf stent graft can be theoretically employed in almost half of the cases from an all-comers cohort of patients with TAAA. Improvement of device profile and creation of a dedicated infrarenal component are warranted to increase overall feasibility. Female gender significantly affects the overall feasibility. Clinicaltrials.gov NCT03959670.

Background Varicose veins recurrence rate remained almost unchanged despite the constant technological advancement in its treatment. The aim of this study is to evaluate the variable accessory saphenous vein (ASV) anatomy at the sapheno-femoral junction (SFJ) as a possible risk factor for recurrent varicose vein (RVV) after great saphenous vein (GSV) radiofrequency thermal ablation (RTA). Methods Two-hundred consecutive patients affected by chronic venous disease (mean age 52.4±10.3 years; 187 women; CEAP C2-C6; 25.2±1.4), underwent to RTA from 2014 to 2016, at our Institute. Preoperatively all patients underwent duplex-ultrasound scanning, reporting the anatomical site, extension of reflux and the ASV anatomy at the SFJ. Duplex ultrasound and physical examination was performed postoperatively at 1, 6 and 12 months, and yearly thereafter. Results Patients were divided in two groups based on the anatomical site of reflux: group A (N.=187) including GSV and SFJ, group B (N.=82) including SFJ reflux. There was no preoperative statistical difference between the two groups. At a mean follow-up of 29.7±2.4 months, a freedom from recurrent varicose vein and GSV recanalization was: 100% and 100% at 1 month, 95.9% and 99.1% at 1 year, 93.7% and 96.7% at 3 years, respectively. A higher rate of RVV was documented for patients in group A at 3-year of follow-up (P=0.042). Cox regression analysis found, among five potential predictors of outcome, that direct confluence of ASV in SFJ (HR=1.561; 95% CI: 1.0-7.04; P=0.032) was a negative predictors of 1-year RVV. Conclusions Sapheno-femoral junction morphology may affect recurrent varicose veins formation. In particular, a concomitant incompetence of the accessory saphenous vein or its directly confluence into the SFJ could represent an indication to simultaneous treatment by non-surgical techniques (RTA or laser) and avoid surgical ligation.

Abdominal endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR) have changed the aortic surgery, due to several advantages in terms of reduced morbidity and mortality. However, increasing rate of late complications requiring secondary procedures has been observed over time. Even if the majority of them may be treated by means of endovascular techniques, late open surgical conversion (LOSC) is required in specific situations. This paper aims to provide our single-center experience with LOSCs and an updated review of the literature. From 1995 to 2020, indications and outcomes of patients treated with LOSC for failed EVAR and TEVAR, at our institutions, were analyzed. LOSC was required to treat a broad range of complications that were classified into two main groups: "disease related" and "stent-graft (SG) related." Among the 121 patients treated with LOSC after EVAR, endoleak (75.2%) represented the most common indication. The overall 30-day mortality rate was 3.3%. A higher mortality rate was associated with infection after EVAR (p. 006). Among the 81 patients treated with LOSC after TEVAR, endoleak (32.1%) was the most common indication. The overall 30-day mortality rate was 13.6% with a higher incidence in the SG-related group (p. 02). LOSC is associated with an increased surgical complexity, in both the abdominal and thoracic area, that results in higher morbidity and mortality rates compared with standard open repair. Depending on the indication to LOSC, specific surgical maneuvers are required to improve clinical outcomes.

Purpose: To describe a new custom-made thoracic device able to seal against the aortic wall and occlude intercostal arteries for spinal cord preconditioning during the first thoracic stage of a thoracoabdominal endovascular repair. Technique: The custom-made device, based on the Zenith Alpha stent-graft, combines different features from 2 previously described devices: the outer part is designed with a bell-bottom configuration similar to the “Embo” stent-graft, while the inner part mimics the “2 in 1” design. The outer stent-graft is designed to span the entire length of the thoracic aorta and cover as many intercostal arteries as possible during the first stage to effectively precondition the spinal cord. The sutured inner component is customizable in diameter and 20 to 40 mm shorter than the outer stent-graft. The technique has been used in 5 patients. Conclusion: The use of this new custom-made thoracic stent-graft might represent an additional tool for effectively preconditioning the spinal cord during fenestrated and branched staged procedures whenever a proximal thoracic proximal component is needed.

Objective We compared the theoretical anatomic feasibility of endovascular treatment of thoracoabdominal aortic aneurysms (TAAAs) with three off-the-shelf multibranched stent-grafts: t-Branch (Zenith t-Branch; Cook Medical, Bloomington, Ind), Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE; W. L. Gore & Associates, Flagstaff, Ariz), and E-nside (E-nside multibranch stent graft system; Jotec GmbH, Hechingen, Germany). Methods Computed tomography scans of patients with degenerative TAAAs treated from 2007 to 2019 were reviewed, and the anatomic feasibility of the multibranched stent-grafts was assessed according to the manufacturer's instructions for use. The anatomic factors determining the overall feasibility were divided into access feasibility, aortic feasibility, and visceral vessel feasibility. Results Degenerative TAAAs in 268 patients were analyzed. The overall feasibility did not differ significantly (TAMBE, 33%; t-Branch, 39%; E-nside, 43%; P = .271). Access, aortic, and visceral vessel feasibility alone excluded 18% to 22%, 35% to 49% and 21% to 26% of the patients respectively. The only significant difference between the devices was in aortic feasibility (P = .005), which was more frequently limited by the proximal aortic neck diameter in the TAMBE cohort and the inner visceral aortic diameter in the t-Branch cohort. The overall treatment feasibility using any of the three devices would have been 58%. Conclusions The new investigational off-the-shelf multibranched stent-grafts did not significantly improve the theoretical applicability in an extensive cohort of patients with TAAAs. Improvements are warranted to increase their overall feasibility.