Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) Study

Background: Since 2010, the Ovation Abdominal Stent Graft System has offered an innovative sealing option for abdominal aortic aneurysm (AAA) by including a sealing ring filled with polymer 13 mm from the renal arteries. In August 2020, the redesigned Ovation Alto, with a sealing ring 6 mm closer to the top of the fabric, received CE Mark approval. Objective: This registry study aims to evaluate intraoperative, perioperative, and postoperative results in patients treated by the Alto stent graft (Endologix Inc.) for elective AAA repair in a multicentric consecutive experience. Methods: All consecutive eligible patients submitted to endovascular aneurysm repair (EVAR) by Alto Endovascular AAA implantation will be included in this analysis. Patients will be submitted to EVAR procedures based on their own preferences, anatomical features, and operators experience. An estimated number of 300 patients submitted to EVAR with Alto stent graft should be enrolled. It is estimated that the inclusion period will be 24 months. The follow-up period is set to be 5 years. Full data sets and cross-sectional images of contrast-enhanced computed tomography scan performed before EVAR, at the first postoperative month, at 24 or 36 months, and at 5-year follow-up interval will be reported in the central database for a centralized core laboratory review of morphological changes. The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with the Alto stent graft in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will be also addressed: operative time; intraoperative radiation exposure; contrast medium usage; AAA sac shrinkage at 12-month and 5-year follow-up; any potential role of patients' baseline characteristics, valuated on preoperative computed tomography angiographic study, and of device configuration (number of component) in the primary endpoint. Results: The study is currently in the recruitment phase and the final patient is expected to be treated by the end of 2023 and then followed up for 5 years. A total of 300 patients will be recruited. Analyses will focus on primary and secondary endpoints. Updated results will be shared at 1- and 3-5-year follow-ups. Conclusions: The results from this registry study could validate the safety and effectiveness of the new design of the Ovation Alto Stent Graft. The technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on-label

L'istituto della mediazione/conciliazione fra luci e ombre. Alcune riflessioni medico-legali

The Authors examine the regulatory procedure that led to the introduction of the institution of mediation/reconciliation in Italy, in order to permit speedier, less costly resolution of some controversial disputes implicating available rights through simplified procedures. However, they simultaneously point out the more controversial aspects of mediation, among which are the compulsoriness of the institution, as a condition for prosecuting and the professionalism and training of the mediator, in light, too, of recent judgements by the Constitutional Court, Merit Courts and Regional Administrative Courts, and the possibility that the judge infers evidence, during the subsequent judgement, charged to the party who, without valid reason, did not participate in the mediation. Finally, special attention is dedicated to possible forensic implications, referring to cases of medical liability, in which a proposal of conciliation would necessarily include an evaluation of the status of the claim, the confirmation of the nexus of the material causality and the quantum compensation

The Indigo System in Acute Lower-Limb Malperfusion (INDIAN) Registry: Protocol

Background: Acute lower limb ischemia (ALLI) poses a major threat to limb survival. For many years, surgical thromboembolectomy was the mainstay of treatment. Recent years have brought an endovascular revolution to the management of ALLI. It seems that the newly designed endovascular thrombectomy devices may shift treatment recommendations toward endovascular options. This protocol study aims to collect evidence supporting the latest hypothesis.Objective: The devices under investigation are the Penumbra/Indigo Systems (Penumbra Inc). The objective of this clinical investigation is to evaluate, in a controlled setting, the early safety and effectiveness of the devices and to define the optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions.Methods: This study will be an interventional prospective trial of patients with a diagnosis of ALLI treated with Penumbra/Indigo devices. This project is intended to be a national platform where every physician invited to participate could register his or her own data procedure. The primary outcome is the technical success of thromboaspiration with the Indigo System. Assessment of vessel patency will be recorded using the Thrombolysis in Myocardial Infarction (TIMI) score classifications before and after use of the device. Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-month follow-up of one class or more as compared to the preprocedure Rutherford classification. Secondary endpoints include the following: (1) safety rate at discharge, defined as the absence of any serious adverse events; (2) primary patency at 1 month, defined as a target lesion without a hemodynamically significant stenosis or reocclusion on duplex ultrasound (>50%) and without target lesion reintervention within 1 month; and (3) limb salvage at 1 month.Results: The study is currently in the recruitment phase and the final patient is expected to be treated by the end of March 2019. A total of 150 patients will be recruited. Analyses will focus on primary and secondary endpoints.Conclusions: These new endovascular thrombectomy devices that are specifically designed for peripheral intervention in this difficult set of patients, as those under investigation in the proposed registry, may offer improved clinical outcomes with lower rates of major systemic and local complications. Following completion of this study, it is expected that the value of the Indigo Thrombectomy System in the treatment of ALLI will be better defined. As a result, a shift of treatment recommendations toward endovascular options may be observed in the near future

The use of a low-profile stent graft with a polymer ring sealing technology combined with bare renal stent (vent technique) in patients with juxtarenal aneurysm not eligible for open surgery and fenestrated endograft

Objective: In cases of juxtarenal abdominal aortic aneurysm (jAAA), endovascular aneurysm repair (EVAR) involves the use of custom-made fenestrated stent grafts, which usually need large-diameter access vessels, superior costs, and a certain time between graft planning and delivery. We report our preliminary experience using the bare renal stent technique (called vent) in combination with the ultralow-profile stent graft Ovation (Endologix, Irvine, Calif) to seal jAAAs in patients evaluated to be unfit for open surgery and not suitable for fenestrated endograft. Methods: A single-center retrospective review of jAAAs treated by Ovation vent technique from January 2015 to December 2018 was conduced. The vent procedure consisted of a modified, off-label deployment of the sealing ring of the ultralow-profile Ovation stent graft close to renal orifices in combination with short bare-metal stents. The exclusion criterion was a diameter >31 mm at the level of the lowest renal artery. Early technical and clinical results, estimated midterm survival, renal artery patency, freedom from type IA endoleak, freedom from reintervention, and freedom from neck enlargement (>2 mm) were reported. Results: Overall, 38 patients had jAAA and were considered unfit for open repair and not eligible for fenestrated EVAR. The proximal neck was <5 mm in all cases (mean, 3.3 ± 1.2 mm). Vent renal stents were implanted bilaterally in 16 patients. Primary technical success was 94.7% (36/38), with satisfactory cannulation of all renal arteries and sealing of the aneurysm in all but two cases because of type IA endoleaks that were treated immediately with success. Primary clinical success at 1 month was 100%. During a median follow-up period of 22.4 ± 3.6 months (range, 1-46 months), no abdominal aortic aneurysm-related deaths occurred, and no patient was lost to follow-up. The survival curve at 1 year and 2 years was, respectively, 96.4% and 91.6% (standard error, 0.57%). There were no cases of neck dilation or endograft migration. Freedom from reintervention at 12 months and 24 months was 100% and 89.5%, respectively (standard error, 0.7%); freedom from type IA endoleak was 100% and patency of the renal artery was 100% at 2 years. Conclusions: The described technique includes the use of a low-profile stent graft with a polymer ring sealing technology combined with bare renal stents that are not competing for the same room. This early experience shows that the vent technique is safe and feasible and increases the range of treatment of those patients with jAAA who are unfit for open repair and for fenestrated EVAR because of several anatomic constraints

The Indigo System in Acute Lower-Limb Malperfusion (INDIAN) registry: Protocol

Background: Acute lower limb ischemia (ALLI) poses a major threat to limb survival. For many years, surgical thromboembolectomy was the mainstay of treatment. Recent years have brought an endovascular revolution to the management of ALLI. It seems that the newly designed endovascular thrombectomy devices may shift treatment recommendations toward endovascular options. This protocol study aims to collect evidence supporting the latest hypothesis.Objective: The devices under investigation are the Penumbra/Indigo Systems (Penumbra Inc). The objective of this clinical investigation is to evaluate, in a controlled setting, the early safety and effectiveness of the devices and to define the optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions.Methods: This study will be an interventional prospective trial of patients with a diagnosis of ALLI treated with Penumbra/Indigo devices. This project is intended to be a national platform where every physician invited to participate could register his or her own data procedure. The primary outcome is the technical success of thromboaspiration with the Indigo System. Assessment of vessel patency will be recorded using the Thrombolysis in Myocardial Infarction (TIMI) score classifications before and after use of the device. Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-month follow-up of one class or more as compared to the preprocedure Rutherford classification. Secondary endpoints include the following: (1) safety rate at discharge, defined as the absence of any serious adverse events; (2) primary patency at 1 month, defined as a target lesion without a hemodynamically significant stenosis or reocclusion on duplex ultrasound (>50%) and without target lesion reintervention within 1 month; and (3) limb salvage at 1 month.Results: The study is currently in the recruitment phase and the final patient is expected to be treated by the end of March 2019. A total of 150 patients will be recruited. Analyses will focus on primary and secondary endpoints.Conclusions: These new endovascular thrombectomy devices that are specifically designed for peripheral intervention in this difficult set of patients, as those under investigation in the proposed registry, may offer improved clinical outcomes with lower rates of major systemic and local complications. Following completion of this study, it is expected that the value of the Indigo Thrombectomy System in the treatment of ALLI will be better defined. As a result, a shift of treatment recommendations toward endovascular options may be observed in the near future

CagA positive Helicobacter pylori infection may increase the risk of food allergy development

The aim of this study was to test whether patients with symptomatic food allergy and significant levels of immunoglobulin E (IgE) to alimentary antigens were more likely infected by H. pylori, especially by strains expressing the CagA protein, with respect to controls. A group of 38 patients with symptomatic food allergy and 53 age-matched controls were examined serologically for H. pylori infectious status, and for CagA seropositivity. IgE to alimentary allergens were measured by a commercial kit. The prevalence of H. pylori infection in patients with food allergy and controls was similar (42.1%, and 48.3%, respectively. However, anti-CagA antibodies in H. pylori- infected persons were detected in 62.5% of patients with food allergy, and 28% of controls (P = 0.030, odds ratio = 4.29). The mean level of IgE to the most common alimentary antigens in serum samples from infected patients with anti-CagA antibodies was significantly higher than in CagA-negative infected patients: 3.28 kU/L (SD 3.93), vs. 1.99 kU/L (SD 1.53), P = 0.002, 95% confidence interval = 0.61 to 2.53). Infection by CagA-positive H. pylori increases the risk of developing food allergy

Food allergy and Helicobacter pylori infection

Background. Most antigens reach the immune system through mucosae. Gastrointestinal mucosa is a barrier for alimentary antigens. Inflammatory processes, such as Helicobacter pylori-associated gastritis, could alter the integrity of the gastric barrier, increase the mucosal permeability and enhance crossing of food antigens which may stimulate allergic reactions. Purpose. The aim of this study was to establish whether patients with symptomatic food allergy and detectable immunoglobulin E (IgE) to alimentary antigens were infected by Helicobacter pylori more often than controls, and to determine the phenotype of the infecting Helicobacter pylori. Patients and Methods. Thirty-eight consecutive patients with symptomatic food allergy and serum IgE to alimentary antigens, and 53 consecutive age-matched controls (subjects without food allergy and detectable levels of IgE anti-alimentary antigens) living in the same area and attending the same institution were investigated serologically to determine the prevalence of Helicobacter pylori infection, and an immune response to CagA, a marker of the most pathogenic strains. IgE to alimentary allergens were measured by a commercial kit. Results. The prevalence of Helicobacter pylori infection in patients with food allergy and controls was similar (42.1% and 47.1%, respectively. Anti-CagA antibodies in Helicobacter pylori-infected persons were detected in 62.5% of patients with food allergy and 28.0% of controls (p = 0.030, odds ratio = 4.29, RR = 2.23). The mean IgE level to the most common alimentary antigens was increased in CagA-positive, with respect to the CagA-negative, patients. Conclusions. The enhanced mucosal and inflammatory lesions commonly found in individuals infected by CagA-positive Helicobacter pylori strains could increase the epithelial permeability and render non-selective the passage of allergens which, in atopic persons, could directly stimulate an IgE response. Infection by CagA-positive Helicobacter pylori may increase the risk of food allergy

Most Helicobacter pylori infected patients have specific antibodies, and some also have H. pylori antigens and genes in the bile: is it a risk factor for gallstone formation ?

Bile may contain a 130-kDa prote in endowed with aminope ptidase activity and the ability to promote chole ste rol crystallisation. As . 90% of H. pylori strains have a similar pe ptidase activity, and half the isolate s expre ss a 110- to 140-kDa antigen, the CagA prote in, we inve stigate d a possible association between H. pylori infe ction and gallstone s, and the presence in bile samples of factors related to H. pylori that could increase chole sterol crystallization. The prevale nce of H. pylori infe ction was 82.1% in 112 patients with gallstone s and 80.3% in 112 controls (NS) . Fifteen bile samples out of 23 specimens from infe cted patie nts (65.2% ) containe d anti-CagA antibodie s. A ; 60-kDa antigen only reacting with an anti-CagA antibody was found in ® ve bile samples (21.7% ) from 23 infected patients. One bile sample (4.1% ) containe d ureA and cagA genes of H. pylori. The homology of CagA with the N-te rminal seque nce of aminope ptidase N was very low. We conclude d that the pre sence of speci® c antibody to H. pylori in most bile sample s tested and of an H. pylori putative antigen in a discre te number of case s may repre sent factors that incre ase the risk of gallstone formation