Development of a porcine acellular bladder matrix for tissue-engineered bladder reconstruction

PURPOSE: Enterocystoplasty is adopted for patients requiring bladder augmentation, but significant long-term complications highlight need for alternatives. We established a protocol for creating a natural-derived bladder extracellular matrix (BEM) for developing tissue-engineered bladder, and investigated its structural and functional characteristics. METHODS: Porcine bladders were de-cellularised with a dynamic detergent-enzymatic treatment using peristaltic infusion. Samples and fresh controls were evaluated using histological staining, ultrastructure (electron microscopy), collagen, glycosaminoglycans and DNA quantification and biomechanical testing. Compliance and angiogenic properties (Chicken chorioallantoic membrane [CAM] assay) were evaluated. T test compared stiffness and glycosaminoglycans, collagen and DNA quantity. p value of < 0.05 was regarded as significant. RESULTS: Histological evaluation demonstrated absence of cells with preservation of tissue matrix architecture (collagen and elastin). DNA was 0.01 μg/mg, significantly reduced compared to fresh tissue 0.13 μg/mg (p < 0.01). BEM had increased tensile strength (0.259 ± 0.022 vs 0.116 ± 0.006, respectively, p < 0.0001) and stiffness (0.00075 ± 0.00016 vs 0.00726 ± 0.00216, p = 0.011). CAM assay showed significantly increased number of convergent allantoic vessels after 6 days compared to day 1 (p < 0.01). Urodynamic studies showed that BEM maintains or increases capacity and compliance. CONCLUSION: Dynamic detergent-enzymatic treatment produces a BEM which retains structural characteristics, increases strength and stiffness and is more compliant than native tissue. Furthermore, BEM shows angiogenic potential. These data suggest the use of BEM for development of tissue-engineered bladder for patients requiring bladder augmentation

Open vascular surgery training in the endovascular era: 5-year experience with cadaver laboratory

Background: Vascular cadaver laboratory (CAD LAB) courses included vascular exposure techniques and simulations of open procedures. Aim of the study was to demonstrate the benefit of cadaver laboratory (CAD LAB) courses to improve trainees' experience in open surgical vascular procedures. Methods: Between 2014 and 2020, 162 vascular surgeons or medical trainees (mean age 28 years) participated in vascular CAD LAB courses in Italy and France. Outcomes were measured using the Linkert survey, performed pre- and post-course to evaluate self-efficacy/confidence, surgical experience and resident perception of the course with a range score from 0 to 5 for each point. Anatomical knowledge improvement was measured using a questionnaire with multiple answers pre- and post-course. The course was considered to have yielded a positive result if the post-course Linkert survey score increased by ≥2 points, or in the case of an increase of at least 30% above the baseline value of the multiple questionnaires. Results: Post-course questionnaires were positive for all outcomes evaluated. Participants' perception of the usefulness of the CAD LAB evaluation was 4.8 out of 5. For the vascular CAD LAB, participant anatomical knowledge improved overall from an average of 55% to 93% (P < .001), and self-efficacy/confidence improved from 2.3 to 4.5 out of 5 (P < .001). Regarding the different operative procedures, the greatest self-efficacy/confidence improvement was recorded in carotid endarterectomy and aortic procedures (+50% and +66% respectively; P < .001). The city location (Italy vs. France) did not affect the results. Conclusions: CAD LAB courses were shown to be effective in increasing participants' self-efficacy, confidence, and anatomical knowledge in open vascular surgical procedures

Impact of Proximal Neck Anatomy on Short-Term and Mid-Term Outcomes After Treatment of Abdominal Aortic Aneurysms With New-Generation Low-Profile Endografts. Results From the Multicentric “ITAlian North-East Registry of ENDOvascular Aortic Repair With the BOltOn Treo Endograft (ITA-ENDOBOOT)”

Background: The aim of the study was to evaluate the short-term and mid-term technical and clinical outcomes of the Bolton Treo endograft in subjects with abdominal aortic aneurysm (AAA) requiring endovascular aortic repair (EVAR) and assess if presence of hostile proximal neck would represent a risk factor for increased failure rates. Methods: A retrospective review of all consecutive patients who had undergone elective or non-elective EVAR with the Bolton Treo endograft at 5 institutions located in the North-East of Italy (January 2016–December 2020) was performed. The main exposure variable for this study was presence of hostile (HAN) or friendly (FAN) aortic neck. Results: A total of 137 consecutive patients were treated with the Bolton Treo endograft at participating institutions; of these 63 (46%) presented HAN while 74 (54%) had FAN. At baseline, no significant differences were observed in the distribution of demographics and comorbidities between study groups. Two type Ia endoleaks (EL) were detected at completion angiography, all in patients with HAN but none in patients with FAN (3% vs. 0%, P = 0.04), but no type III EL were identified in the whole cohort. The median duration of follow-up in the study cohort was 30 months (IQR 22–34 months) and was similar between study groups (P = 0.87). At 3-years, survival estimates were 89% and 91% (P= 0.82) in patients with HAN and FAN, respectively. At three years, patients with HAN had significantly lower freedom from type IA endoleak as compared with patients with FAN (87% vs. 94%, P= 0.02). No significant differences were found between study groups in the three-year estimates of freedom from reinterventions (80% vs. 86%, P= 0.28). Using cox proportional hazards, presence of type II EL (HR 3.15, 95%CI 1.18–8.5, P= 0.02) and presence of type IA EL (HR 4.22, 95%CI 1.39–12.85, P= 0.01) were found as independent predictors for reinterventions in univariate analysis, although they were no longer significant in the multivariate model. Freedom from sac increase >5mm at three years were not significantly different between study groups (92% vs 91%, P= 0.95). Conclusions: Within a contemporary multicentric real-world experience, EVAR with the Bolton Treo endograft shows a satisfactory safety profile in the immediate postoperative phase and acceptable outcomes during mid-term follow-up. Presence of HAN is correlated with development of type Ia EL (either early following stent-graft implantation or late after EVAR) which, in turn, may represent a significant factor leading to reinterventions

Early and mid-term outcomes following open surgical conversion after failed endovascular aneurysm repair from the "Italian North-easT RegIstry of surgical Conversion AfTer Evar" (INTRICATE)

To report the early and mid-term outcomes following open surgical conversion (OSC) after failed endovascular aortic repair (EVAR) using data from a multicentric registry

Preliminary results of endovascular aneurysm sealing from the multicenter Italian Research on Nellix Endoprosthesis (IRENE) study

Objective: Because of advances in technology and experience of the operator, endovascular aneurysm repair (EVAR) has supplanted open repair to treat abdominal aortic aneurysm (AAA). The low 30-day mortality and morbidity of EVAR make the endovascular approach particularly suitable for patients at high surgical risk. However, endoleak or endograft migration requiring secondary intervention or open surgical conversion is a limitation of EVAR. The Nellix system (Endologix, Inc, Irvine, Calif) has been designed to seal the entire AAA to overcome these limitations with EVAR. We report the results of a retrospective, multicenter study with endovascular aneurysm sealing (EVAS) aimed to assess technical success, procedure-related mortality, complications, and reinterventions. Methods: This study included patients selected for elective treatment with the Nellix device per the endovascular repair protocol at 16 Italian vascular centers. All patients were enrolled in a postoperative surveillance imaging program including duplex ultrasound investigations, computed tomography, and magnetic resonance controls following local standards of care. Results: From 2013 to 2015, there were 335 patients (age, 75.5 ± 7.4 years; 316 men) who underwent elective EVAS. In 295 cases (88.0%), EVAS was performed under standard instructions for use of the Nellix system. Preoperative aneurysm diameter was 55.5 ± 9.4 mm (range, 46-65 mm). The inferior mesenteric artery and lumbar arteries emerging from the AAA were patent in 61.8% and 81.3% of cases, respectively. Chimney grafts were electively carried out in eight cases (2.4%). One (0.3%) intraprocedural type IB endoleak was observed and promptly corrected. Device deployment was successful in all patients, with no perioperative mortality. Early (≤30 days) complications included 1 (0.3%) type IA endoleak, 2 (0.6%) type II endoleaks (0.6%), 2 (0.6%) stent occlusions (0.6%), 3 (0.9%) distal embolizations, and 2 (0.2%) femoral artery dissections. Six (2.9%) patients underwent reinterventions. At 1-year follow-up, complications included 3 (1.1%) type II endoleaks, 4 (1.4%) type IA endoleaks, 1 (0.3%) type IB endoleak, 2 (0.7%) distal stent migrations, 5 (1.8%) distal embolizations, and 1 (0.3%) stent occlusion. Twelve patients (3.7%) underwent reinterventions, including four (1.4%) surgical conversions due to aortoduodenal fistula (1), endograft infection (1), and type IA endoleak that was unsuccessfully treated percutaneously (2). Two AAA-related deaths occurred. Freedom from aneurysm-related reintervention was 98.3% at 1-month and 94.7% at 12-month follow-up. Conclusions: The preliminary results of this real-world multicenter study showed that EVAS with Nellix for the management of AAAs appears feasible. This device platform is associated with acceptable procedure-related mortality and low overall complication and reintervention rates. Definitive conclusions on the value of this novel device await long-term follow-up data

Mechanical thrombectomy in acute limb ischemia: ad Interim results of the INDIAN UP Trial

BACKGROUND: Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischemia (ALLI) is becoming a fundamental alternative to surgical and intra-arterial thrombolysis. The INDIAN UP trial represents the second phase of the Italian national multicenter trial evaluating the safety and effectiveness of the device in the treatment of ALLI.METHODS: To assess vessel patency, the TIPI (Thrombo-aspiration In Peripheral Ischemia), is used. The TIPI flow in three different moments: at presentation, immediately after thromboaspiration, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularization TIPI 2 -3. Safety and clinical success rate were collected at one month follow-up.RESULTS: A total of 250 patients were enrolled. The mean age was 72.2 &amp; PLUSMN;13.1 years and 72.1% were male. Rutherford grade on enrolment was I in 10.8%, IIa in 34.9%, and IIb in 54.4%. Primary technical success (TIPI 2-3 flow) was achieved in 90.8% of patients. Adjunctive procedures were needed in 158 cases. After all interventions, assisted primary technical success was 96.4%. No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, survival rate was 97.2%, limb salvage was 97.6%. Primary patency was 89.6% and 13 (5.4%) reinterventions were registered.CONCLUSIONS: The updated results of the INDIAN UP trial have confirmed the high value of the mechanical thromboaspiration device Indigo Penumbra in the treatment of ALLI in a large variety of clinical and anatomical settings

The "Woundosome" Concept and Its Impact on Procedural Outcomes in Patients With Chronic Limb-Threatening Ischemia

This editorial assembles endovascular specialists from diverse clinical backgrounds and nationalities with a global call to address key challenges to enhance revascularization in chronic limb-threatening ischemia (CLTI) patients.- Dedicated below-the-ankle (BTA) angiography and revascularization is underutilized in ischemic foot treatment. Existing guidelines do not address comprehensive BTA vessel analysis. CLTI trials also often lack data on in-line arterial flow to the ischemic lesion and BTA vessel evaluation, hindering outcome assessment.- Dedicated multi-planar angiographic evaluation of the distal microcirculation is key: Direct arterial flow or good-quality collaterals are crucial in influencing wound healing and need to be assessed diligently to the level of the distal ischemic wound territory, termed “woundosome.”- An important primary emphasis of future trials should be on validating technologies and strategies for assessing tissue perfusion before, during, and after revascularization undertaken to heal tissue loss in CLTI patients. This will allow determination of a potentially significant delta in tissue perfusion prior to and following intervention at the “woundosome” level. Once changes in arterial perfusion have been identified as positively correlated to wound healing, these could serve as a much-needed novel primary technical outcome measure for patients with tissue loss undergoing surgical, hybrid, or endovascular revascularization