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Background: data from clinical experiences with Absorb bioresorbable scaffold (BRS) in STEMI raised concerns among clinicians about the device safety because a noteworthy scaffold thrombosis (ScT) rate was reported at early and long-term follow-up. Nevertheless, pre-specified technical suggestions of how to perform an optimal BRS procedure in STEMI were lacking. In this study we sought to assess the 1-year results following a pre-specified BRS implantation strategy in ST-elevation myocardial infarction (STEMI) patients undergoing primary PCI (pPCI).Methods: This is a prospective, multicenter study on 505 STEMI patients undergoing pPCI with Absorb following a dedicated implantation protocol. The primary end-point (a device oriented composite end-point (DOCE) of cardiac death, target-vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) within 30 days) was already reported. We here present DOCE, its singular components and ScT rates (secondary end-points) at 1-year.Results: According to the study protocol direct Absorb implantation was feasible in 47 (9.3%) patients while post-dilatation was performed in 468 (92.7%) cases. The hierarchical DOCE rate at 1-year was 1.2% (0.4% cardiac death, 0.4% TV-MI and 0.8% ID-TLR) versus 0.6% at 30-day. Two episodes (0.4%) of ScT (one probable subacute and one late definite) were reported. At 1-year, 99.2% patients were on dual antiplatelet therapy (95% with ticagrelor or prasugrel).Conclusions: A pre-specified Absorb implantation strategy in STEMI patients was associated with persistent low DOCE and ScT rates at 1-year. Longer term follow-up is needed to assess the role of this strategy on preventing very-late events (NCT02601781). [ABSTRACT FROM AUTHOR]

Objective: The Rigenera system is a new standardised micrograft preparation system. It works by means of automated mechanical disaggregation of small tissue samples, extracting only the smallest cells (<50µm). The aim of this study was to retrospectively evaluate patients affected by chronic ulcers and who were treated with the micrograft preparation method. Method: Chronic ulcers have been included regardless of the cause. The specimen was collected with a 3mm diameter biopsy punch and immediately dissociated by means of the Rigenera System. The obtained suspension was placed on a scaffold of equine collagen. Results: We included 15 patients (four males, 11 females) with a mean age of 72.2±8.41 (mean±standard deviation) years. In seven patients the ulcers were related to the complications of diabetes, post-traumatic in a further three diabetic patients, vasculitis in one patient, and four patients had venous leg ulcers (VLUs). The median main diameter was 5.0cm and the median estimated area was 43.96cm². The ulcers were present from a mean of 4.50±2.30 months before inclusion in this study. At the second week the wounds were reduced by 37.33%±19.35%, at the week eight, nine patients (60.0%) were healed, and at week 16, 13 (86.7%) were healed. The quality of scars was good and did not deteriorate at the six month follow-up. Conclusion: The simplicity of the approach, the minimal invasiveness of the specimen collection, and the good quality of scarring of healed wounds, confirmed in the follow-up, makes this micrograft preparation method a useful tool to use on large or complex wounds. Declaration of interest: None to declare. [ABSTRACT FROM AUTHOR]

Aim: The present work aims to develop a porous cross-linked scaffold based on collagen (Coll) and chitosan (Cs) intended for skin repair and regeneration. Method: Different cross-linking methods have been investigated: UV irradiation in presence or in absence of glucose, treatment with tannic acid and ultrasonication. Freeze-drying process was employed allowing to achieve more stable systems, characterized by high porosity and stability. To assess the influence of critical variables, especially the concentration of CS and the CS and Coll concentration ratio, on scaffold mechanical properties, a Design of Experiments (DoE) approach was exploited. Scaffolds morphological, mechanical, hydration and degradation properties were assessed. In vitro and in vivo assays on fibroblast model cell line and on a murine model were also performed. Results / Discussion: The ultrasonication method was found to be the ideal cross-linking method, because it allowed to obtain hydrogels with the best compromise between mechanical and elastic properties. Furthermore, the DoE approach was successfully employed to investigate the influence of Cs concentration (% w/w) and Cs and Coll weight ratio on ultrasonicated cross-linked scaffold mechanical properties, finding the best Coll/Cs quantitative composition. Highly porous scaffolds able to absorb huge amounts of aqueous fluids, characterized by good mechanical resistance to compression and suitable degradation properties, were obtained. In vitro studies confirmed the scaffold capability to promote cell proliferation and adhesion. The regenerative potential of the scaffold developed was confirmed in vivo. Conclusion: A promising biodegradable cross-linked porous scaffold consisting of Coll and Cs was successfully developed for the treatment of chronic skin ulcers [ABSTRACT FROM AUTHOR]

Aim: This work aims on the design and development of cricket-based gas foamed fibers enriched with hydroxyapatite, able to mimic the native extracellular matrix and to restore the wound site. Method: Pullulan (PL), Hydroxyapatite nanopowder (HP), Citric Acid (CA) and crickets (CR) were used for scaffold preparation. Three different solutions were prepared: PL-HP, PL-CR, PL-CR-HP. The polymeric blends were electrospun using an electrospinning apparatus and cross-linked by heating. Subsequently, the electrospun fibers were immersed in sodium borohydride solution (NaBH4) for 15 min at room temperature to allow the gas foaming. The surface morphology of the 3D scaffolds was studied by SEM and the compression test was conducted using a Texture Analyser. Cell adhesion and proliferation were assessed on human fibroblasts and human adipose stem cells. An in vivo efficacy evaluation was also performed on male rats. Results / Discussion: The morphological analysis evidenced a nanofibrous structure, and HP was dispersed into the matrix. The 2D electrospun fibers were gradually modified into 3D structure during the treatment with NaBH4 solution. Moreover, the compression test highlighted that the presence of both HP and CR increased the systems resistance. Both cell lines were able to adhere and proliferate onto the systems. Moreover, the in vivo efficacy evaluation confirmed the re-epithelialization of the wound site when treated with the systems. Conclusion: Cricket-based gas foamed fibers enriched with HP were successfully developed, representing an interesting tool to effectively tackle wounds. [ABSTRACT FROM AUTHOR]

Scopo: The use of scaffolds and autologous skin cell suspension grafts represents an efficient alternative to reconstructive plastic surgery in the trauma department. In our twelve months of experience, we have used bovine scaffolds and autologous skin cell suspension on injuries of traumatic nature in patients who couldn't undergo reconstructive surgery because of probable therapeutic failure. Patients were ineligible for surgery due to the following criteria: elderly age, comorbidities (decompensated diabetes, infections, vasculopathy, venous insufficiency, heart disease, obesity), allergies, systemic therapies with glucocorticoids or chemotherapy, areas damaged by skin aging and patient's lack of consent to surgery. Resorting to scaffolds combined with autologous skin cell suspension grafts represents a therapeutic solution that despite the absence of donor site morbidity allows the coverage of areas damaged by tegumental loss, with excellent effective and aesthetic results. Metodi: The treatment, following debridement, demanded the urgent use of scaffolds and grafts of autologous skin cell suspension. The "Wound Bed Preparation" (WBP) is an essential requirement for their correct use. Risultati: Presentation of 3 cases. Conclusioni: Scaffolds and autologous skin cell suspension grafts represent the solution for those traumas where reconstructive surgery is hindered by factors that predict reparative failure, thus reducing the increase in the risk of major amputations. [ABSTRACT FROM AUTHOR]

Aim: The recent introduction amongst the scaffolds used in wound care, of acellular fish skin graft, has marked a significant step forward in regenerative medicine and surgery, by offering the possibility of an effective and quick recovery of the healing process, and regeneration of tissues with similar, if not identical characteristics to the damaged native ones. Drawing on the clinical experience of our Vulnology Operative Unit we analysed the clical cases we treated and the results obtained, in order to define which are the actual indications to applying these biomaterials. Method: Retrospective analysis of the over 100 cases we treat with this method, highlighting the results obtained in terms of time (improvement/healing of the lesion) and of quality of the regenerated tissue (functional and aesthetic results), in wounds of different aetiology. Results: All wounds, both acute and chronic, of any aetiology, showed significant re-start of the healing process, with quicker responses in more recent wounds. In over 75% of cases complete healing was achieved, with the formation of a stable tissue, with characteristics totally akin to the native one. Conclusions: Bio-stimulation with acellular fish skin grafts is effective in the treatment of any tissue loss, be it acute or chronic, with response timings which vary according to the wound itself, but always with optimal regenerative outcomes, both from a functional and an aesthetic point of view. [ABSTRACT FROM AUTHOR]

Background: The treatment of symptomatic cartilage defects of the patella is particularly challenging, and no gold standard is currently available. Purpose: To evaluate the clinical results of a biphasic cell-free collagen-hydroxyapatite scaffold and to evaluate osteochondral tissue regeneration with magnetic resonance imaging (MRI). Study Design: Case series; Level of evidence, 4. Methods: Thirty-four patients (18 men and 16 women; mean ± SD: age, 30.0 ± 10 years) were treated by scaffold implantation for knee chondral or osteochondral lesions of the patella (area, 2.1 ± 1 cm2). The clinical evaluation was performed prospectively at 12 and 24 months via the IKDC (International Knee Documentation Committee; objective and subjective) and Tegner scores. MRI evaluation was performed at both follow-ups in 18 lesions through the MOCART score (magnetic resonance observation of cartilage repair tissue) and specific subchondral bone parameters. Results: A statistically significant improvement in all the scores was observed at 12- and 24-month follow-up as compared with the basal evaluation. The IKDC subjective score improved from 39.5 ± 14.5 to 61.9 ± 14.5 at 12 months (P > .0005) with a further increase to 67.6 ± 17.4 at 24 months of follow-up (12-24 months, P = .020). The MRI evaluation showed a stable value of the MOCART score between 12 and 24 months, with a complete filling of the cartilage in 87.0% of the lesions, complete integration of the graft in 95.7%, and intact repair tissue surface in 69.6% at final follow-up. The presence of osteophytes or more extensive bony overgrowth was documented in 47.8% of the patients of this series, but no correlation was found between MRI findings and clinical outcome. Conclusion: The implantation of a cell-free collagen-hydroxyapatite osteochondral scaffold provided a clinical improvement at short-term follow-up for the treatment of patellar cartilage defects. Women had lower outcomes, and the need for realignment procedures led to a slower recovery. MRI evaluation showed some abnormal findings with the presence of bone overgrowth, but no correlation has been found with the clinical outcome. [ABSTRACT FROM AUTHOR]

Breast cancer treatment has deeply changed in the last decades, since clinical and oncological cure cannot be achieved without patient's satisfaction in term of aesthetic outcomes. Several methods have been proposed to objectively assess these results. However, Italian breast centers have not yet agreed on measurable, reproducible and validated aesthetic outcome indicators to monitor their performance., Methods: The study was designed and conducted by Senonetwork, a not-for-profit association of Italian breast centers. Ten breast centers were selected based on specific eligibility criteria. This multicentre observational prospective study recruited 6515 patients with diagnosis of in situ or invasive breast cancer who underwent breast surgery in the years 2013-2016. Thirteen indicators of aesthetic results and of related quality of care were analyzed. Data collection and analysis were conducted using a common study database., Results: On average, seven out of ten centers were able to collect data on the proposed indicators with a proportion of missing values < 25%. By expert consensus based on study results, some seven indicators have been defined as "mandatory" while the remaining six have been defined as "recommended" because they require further refinement before they can be proposed for monitoring aesthetic outcomes or because there are doubts on the feasibility of data collection. The minimum standard is reached for 5 of 13 indicators. This finding and the wide range between centers reveal that there is ample room for improvement., Conclusions: From the present study useful measurable aesthetic parameters have emerged, leading to the definition of target objectives that breast centers can use for benchmarking and improvement of quality of care., Competing Interests: Declaration of competing interest The authors declare that they have no competing interests., (Copyright © 2020 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)

Background: The bioresorbable vascular scaffold (BRS) technology constitutes the new revolution of the coronary artery disease interventional treatment. Currently, three distinct types of BRSs are available but only one, the Absorb BVS, was on the market in 2013 when the Regional Commission for Medical Devices and the Cardiology and Cardiac Surgery Commission of the Emilia-Romagna Region drew up a technical and scientific essay to provide guidance for the introduction of BRS in public and affiliated health facilities. Five preferential indications were given for use: long coronary lesions (>28 mm), ostial lesions (left main stem excluded), complete revascularization in patients aged <50 years, diffuse disease (>40 mm) or involving the mid/distal left anterior descending (LAD) branch in patients <70 years, spontaneous coronary artery dissection., Methods: This survey analyzed data from all the catheterization laboratories in the Emilia-Romagna Region, merged in a unified database., Results: In a 3-year study period, 546 BRS were implanted in 328 patients, corresponding to 1.5% of the drug-eluting stents (DES) used, with a trend towards a progressive increase over time. Initial indications were followed in 200/328 (61.0%) patients (about one third fitting more indications), mainly for treatment of long lesions in vessels >2.5 mm (67%), young patients (31.5%) and mid/distal LAD (28%). In 22.6% of cases the clinical scenario was a ST-segment elevation myocardial infarction, in 39.3% a non-ST-segment elevation acute coronary syndrome. Intracoronary imaging was infrequently used (intravascular ultrasound in 24.7% of cases). In 85 patients (25.9%) a hybrid procedure (BVS/DES) was performed., Conclusions: BRS use has resulted lower than expected, with discrete variability among centers, but according to the initial indications of the Emilia-Romagna Region in the majority of cases. The underuse might have been due to operators' caution in their initial experience. However, the increasing trend may reveal a greater confidence in the implantation technique and the whole amount of safety and efficacy data.

Objective of this study was to assess the clinical performance of bioresorbable vascular scaffold (BVS) compared to everolimus-eluting stent (EES) in subjects with ST-segment elevation myocardial infarction (STEMI). We included all consecutive patients with STEMI who underwent percutaneous coronary intervention (PCI) with BVS implantation in centers participating to the Italian ABSORB Prospective Registry (BVS-RAI) and PCI with EES in the same centers during the same period. The 2 groups were compared. The primary end point was patient-oriented composite end point (POCE) including cardiac death, myocardial infarction, and target lesion revascularization (TLR) at the longest available follow-up. BVS or EES thrombosis at follow-up was also evaluated. Of the 563 patients with STEMI included, 122 received BVS and 441 EES. Procedural success was obtained in 549 (97.5%) cases without significant differences between the 2 groups (BVS 99.3% vs EES 97.0%, p = 0.2). At a median of 220-day (interquartile range 178 to 369) follow-up, no significant differences were observed in terms of POCE (BVS 4.9% vs EES 7.0%, p = 0.4); death (BVS 0.8%, EES 2.0%, p = 0.4), MI (BVS 4.1%, EES 2.0%, p = 0.2), TLR (BVS 4.1%, EES 4.5%, p = 0.8), device thrombosis (BVS 2.5%, EES 1.4%, p = 0.4). All TLR cases were successfully managed with re-PCI in both groups. A propensity matching of the study populations showed no significant differences regarding POCE at the longest available follow-up (odds ratio 0.53, 0.1 to 4.3). In conclusion, in this direct prospective comparison, BVS was associated with similar clinical results compared to EES in the STEMI setting. Larger and adequately powered randomized trials are needed to fully assess the potential clinical benefit of BVS versus the current standard of care in patients with STEMI., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objectives: The aim of this multicentric study was to outline surgical indications and evaluate mid-term outcomes of porcine extracellular matrix (ECM) in surgery for congenital heart disease (CHD)., Methods: The use of ECM was categorized into four major groups: A, valve repair; B, septal reconstruction; C, arterial plasty; D, other use. Primary endpoints of analysis were reintervention (either surgical or interventional) when related to ECM, and functional ECM failure. Secondary endpoints were evidence of calcification and of persistent inflammation at follow-up., Results: One hundred and three patients (M/F = 61/42, median age 19.7 months, 1 day-62 years) underwent surgical repair for CHD. Among ECM use categories, 38 patients were in Group A, 16 in Group B, 71 in Group C and 7 in Group D. There were neither complications nor deaths related to ECM. At a median follow-up of 23.3 months (0.3-55.2), 19 patients underwent reoperation (ECM-related in 6); 11 patients underwent interventional cardiology procedures (ECM-related in 8). Reinterventions were significantly more frequent on the aortic valve (surgical, P = 0.0056) and pulmonary arteries (interventional, P = 0.0159). In addition, interventional procedures on pulmonary arteries were significantly more frequent in infants <12 months (P = 0.0474). No calcifications were detected., Conclusions: Surgical use of ECM in CHD repair is characterized by a suboptimal functional late performance on reconstruction of valve leaflet or pulmonary artery wall. Longer follow-up and larger clinical experience may support these preliminary results on mid-term outcomes, so as to assess the optimal indication for an ECM graft., (© The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Currently, one of the most relevant innovations in interventional cardiology is the advent of bioresorbable vascular scaffolds (BVS). Among the BVS developed so far, the AbsorbTM BVS 1.1 (Abbott®) is one of the two devices that achieved the CE mark for the use in clinical practice. A reasonable amount of clinical evidence on AbsorbTM BVS has been built up from a large series of trials, of which some have been completed and others are in the enrollment and/or follow-up phases. However, at present there is paucity of data on the efficacy and safety of AbsorbTM BVS in patients with more complex coronary artery disease, who represent the majority of those undergoing coronary stenting in everyday clinical practice. To fill this gap, several all-comers registries are ongoing, with the aim to assess the efficacy and safety of the scaffold in subgroups with particularly complex coronary lesions. The AbsorbTM BVS 1.1 registries include IT-DISAPPEARS (NCT02004730), an Italian multicenter registry, started in December 2013, and endorsed by the Italian Society of Invasive Cardiology (GISE). This registry will enroll only patients with long lesions and/or multivessel coronary disease, with an expected considerable proportion of included patients having complex disease. Therefore, the implementation of meticulous and appropriate implantation technique is of key importance for the accurate assessment of scaffold performance in a broad spectrum of coronary lesions. With the aim of standardizing the procedure for patients included in the IT-DISAPPEARS registry, the present article reports the technical features of Absorb TM BVS 1.1 implantation.