Anticoagulation Therapy in Patients With Coronavirus Disease 2019: Results From a Multicenter International Prospective Registry (Health Outcome Predictive Evaluation for Corona Virus Disease 2019 [HOPE-COVID19]).

OBJECTIVES: No standard therapy, including anticoagulation regimens, is currently recommended for coronavirus disease 2019. Aim of this study was to evaluate the efficacy of anticoagulation in coronavirus disease 2019 hospitalized patients and its impact on survival. DESIGN: Multicenter international prospective registry (Health Outcome Predictive Evaluation for Corona Virus Disease 2019). SETTING: Hospitalized patients with coronavirus disease 2019. PATIENTS: Five thousand eight hundred thirty-eight consecutive coronavirus disease 2019 patients. INTERVENTIONS: Anticoagulation therapy, including prophylactic and therapeutic regimens, was obtained for each patient. MEASUREMENTS AND MAIN RESULTS: Five thousand four hundred eighty patients (94%) did not receive any anticoagulation before hospitalization. Two-thousand six-hundred one patients (44%) during hospitalization received anticoagulation therapy and it was not associated with better survival rate (81% vs 81%; p = 0.94) but with higher risk of bleeding (2.7% vs 1.8%; p = 0.03). Among patients admitted with respiratory failure (49%, n = 2,859, including 391 and 583 patients requiring invasive and noninvasive ventilation, respectively), anticoagulation started during hospitalization was associated with lower mortality rates (32% vs 42%; p < 0.01) and nonsignificant higher risk of bleeding (3.4% vs 2.7%; p = 0.3). Anticoagulation therapy was associated with lower mortality rates in patients treated with invasive ventilation (53% vs 64%; p = 0.05) without increased rates of bleeding (9% vs 8%; p = 0.88) but not in those with noninvasive ventilation (35% vs 38%; p = 0.40). At multivariate Cox' analysis mortality relative risk with anticoagulation was 0.58 (95% CI, 0.49-0.67) in patients admitted with respiratory failure, 0.50 (95% CI, 0.49-0.67) in those requiring invasive ventilation, 0.72 (95% CI, 0.51-1.01) in noninvasive ventilation. CONCLUSIONS: Anticoagulation therapy in general population with coronavirus disease 2019 was not associated with better survival rates but with higher bleeding risk. Better results were observed in patients admitted with respiratory failure and requiring invasive ventilation.

Conservative and surgical management of acute isolated syndesmotic injuries: ESSKA-AFAS consensus and guidelines.

PURPOSE: Correct management of syndesmotic injuries is mandatory to avoid scar tissue impingement, chronic instability, heterotopic ossification, or deformity of the ankle. The aim of the present study was to perform a systematic review of the current treatments of these injuries to identify the best non-surgical and surgical management for patients with acute isolated syndesmotic injuries. METHODS: A review of the literature was performed according to the PRISMA guidelines. A comprehensive search of PubMed, Medline, CINAHL, Cochrane, Embase, and Google Scholar databases was performed using the following keywords: "ankle injury", "syndesmotic injury", "chronic", "acute", "treatment", "conservative", "non-operative" "operative", "fixation", "osteosynthesis", "screw", "synostosis", "ligamentoplasties" over the years 1962-2015. RESULTS: The literature search and cross-referencing resulted in a total of 345 references, of which 283 were rejected due to off-topic abstract and/or failure to fulfil the inclusion criteria. After reading the remaining full-text articles, we included four studies, describing non-surgical management, and only two studies investigating surgical management of acute isolated injuries. CONCLUSIONS: The ESSKA-AFAS consensus panel provided recommendations to improve the management of patients with isolated acute syndesmotic injury in clinical practice. Non-surgical management is recommended for stable ankle lesions and includes: 3-week non-weight bearing, a below-the-knee cast, rest and ice, followed by proprioceptive exercises. Surgery is recommended for unstable lesions. Syndesmotic screw is recommended to achieve a temporary fixation of the mortise. Suture-button device can be considered a viable alternative to a positioning screw. Partial weight bearing is allowed 6 weeks after surgery. LEVEL OF EVIDENCE: IV.

Classification and diagnosis of acute isolated syndesmotic injuries: ESSKA-AFAS consensus and guidelines.

PURPOSE: The aim of the present study was to perform a systematic review of the current classification systems, and the clinical and radiological tests for the acute isolated syndesmotic injuries to identify the best method of classification and diagnosis allowing the surgeon to choose the appropriate management. METHODS: A systematic review of the literature according to the PRISMA guidelines has been performed. A comprehensive search using various combinations of the keywords "classification", "grading system", "ankle injury", "ligament", "syndesmotic injury", "internal fixation", "acute", "synostosis", "ligamentoplasties", "clinical", "radiological" over the years 1962-2015 was performed. The following databases were searched: MEDLINE, Google Scholar, EMBASE and Ovid. RESULTS: The literature search resulted in 345 references for classification systems and 308 references for diagnosis methods, of which 283 and 295 were rejected due to off-topic abstract and/or failure to fulfil the inclusion criteria. After reading the remaining full-text articles, we included 27 articles describing classification systems and 13 articles describing diagnostic tests for acute isolated syndesmotic injuries. CONCLUSIONS: The ESSKA-AFAS consensus panel recommends distinguishing acute isolated syndesmotic injury as stable or unstable. Stable injuries should be treated non-operatively with a short-leg cast or brace, while unstable injuries should be managed operatively. The recommended clinical tests include: tenderness on palpation over the anterior tibiofibular ligament, the fibular translation test and the Cotton test. Radiographic imaging must include an AP view and a mortise view of the syndesmosis to check the tibiofibular clear space, medial clear space overlap, tibial width and fibular width. LEVEL OF EVIDENCE: IV.

OCT guided vs. COmplete pci in patieNts with sT segment elevation myocArdial infarCtion and mulTivessel disease: OCT-CONTACT RCT.

BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) of the culprit lesion significantly reduces the risk of cardiovascular death. However, the management of non-culprit lesions in patients with the multivessel disease remains a matter of debate in this setting. It's still unclear if a morphological OCT-guided approach, identifying coronary plaque instability, may provide a more specific treatment compared with a standard angiographic/functional approach. METHODS: OCT-Contact is a prospective, multicenter, open-label, non-inferiority randomized controlled trial. Patients with STEMI with successful primary PCI of the culprit lesion will be enrolled after the index PCI. Patients will be deemed eligible if a critical coronary lesion other than the culprit (associated with a diameter of stenosis ≥50%) will be identified during the index angiography. Patients will be randomized in a 1:1 fashion to OCT-guided PCI of non-culprit lesions (Group A) vs. complete PCI (Group B). PCI in group A will be undertaken according to criteria of plaque vulnerability, while in group B the use of fractional flow reserve will be left at the operators' discretion. Major-adverse cardiovascular events (MACE) are a composite of all-cause mortality, non-fatal myocardial infarction (MI) (excluding peri-procedural MI), unplanned revascularization, and NYHA IV heart failure) will be the primary efficacy outcome. Single components of MACE along with cardiovascular mortality will be the secondary endpoints. . Safety endpoints will embrace worsening of renal failure, procedural complications, and bleedings. Patients will be followed for 24 months after randomization. RESULTS: A sample size of 406 patients (203 per group) is required to provide the analysis an 80% power to detect a non-inferiority in the primary endpoint with an alpha error set at 0.05 and a non-inferiority limit of 4%. CONCLUSIONS: A morphological OCT-guided approach may be a more specific treatment compared with the standard angiographic/functional approach in non-culprit lesions of STEMI patients.

Feasibility and safety of left atrial appendage closure in a patient with previous foramen ovale occlusion: a case report.

BACKGROUND: Left atrial appendage (LAA) closure is an alternative to chronic oral anticoagulation for stroke prevention in patients with atrial fibrillation (AF) at high bleeding risk. Patients with a previous percutaneous closure of a patent foramen ovale (PFO) present an increased risk for developing AF during their life, and the presence of an atrial septal device renders future percutaneous left atrial access more challenging. Very few cases of LAA occlusion in patients with a preexisting PFO closure device have been previously reported. CASE SUMMARY: A 74-years old woman was admitted to our hospital for symptomatic severe anaemia during direct oral anticoagulant treatment. Her past medical history reported an ischaemic stroke at the age of 55, at that time a PFO was diagnosed and a STARFlex™ PFO occluder (NMT Medical, Boston, MA, USA) was implanted. During the current hospitalization, the patient underwent a colonoscopy that showed colonic angiodysplasias unsuitable for endoscopic treatment and LAA closure was indicated for stroke prevention. After a multimodality pre-procedural planning that included a transoesophageal echocardiogram, a cardiac computed tomography scan and a three-dimensional cardiac model printing, the procedure was planned and the LAA successfully occluded. DISCUSSION: LAA closure can be performed safely and effectively in patients carrying a previously implanted PFO occlusion device. In complex settings, a pre-procedural multimodality imaging is critical for improving the procedural safety and success rate. We describe the first case of percutaneous LAA closure in a patient with a prior PFO occlusion with the implantation of a STARflex™ septal occlusion device.

Effectiveness and safety of antithrombotic strategies in elderly patients with acute myocardial infarction.

BACKGROUND: Elderly patients represent a rapidly growing part of the population more susceptible to acute coronary syndromes and their complications. However, literature evidence is lacking in this clinical setting. AIM: To describe the clinical features, in-hospital management and outcomes of "elderly" patients with myocardial infarction treated with antiplatelet and/or anticoagulation therapy. METHODS: This study was a retrospective analysis of all consecutive patients older than 80 years admitted to the Division of Cardiology of St. Andrea Hospital of Vercelli from January 2018 to December 2018 due to ST-elevation myocardial infarction (STEMI) or non-ST elevation myocardial infarction (NSTEMI). Clinical and laboratory data were collected for each patient, as well as the prevalence of previous or in-hospital atrial fibrillation (AF). In-hospital management, consisting of an invasive or conservative strategy, and the anti-thrombotic therapy used are described. Outcomes evaluated at 1 year follow-up included an efficacy ischemic endpoint and a safety bleeding endpoint. RESULTS: Of the 105 patients enrolled (mean age 83.9 ± 3.6 years, 52.3% males), 68 (64.8%) were admitted due to NSTEMI and 37 (35.2%) due to STEMI. Among the STEMI patients, 34 (91.9%) underwent coronary angiography and all of them were treated with percutaneous coronary intervention (PCI); among the NSTEMI patients, 42 (61.8%) were assigned to an invasive strategy and 16 (38.1%) of them underwent a PCI. No significant difference between the groups was found concerning the prevalence of previous or in-hospital de-novo AF. 10.5% of the whole population received triple antithrombotic therapy and 9.5% single antiplatelet therapy plus oral anticoagulation (OAC), with no significant difference between the subgroups, although a higher number of STEMI patients received dual antiplatelet therapy without OAC as compared with NSTEMI patients. A low rate of in-hospital death (5.7%) and 1-year cardiovascular death (3.3%) was registered. Seven (7.8%) patients experienced major adverse cardiovascular events, while the rate of minor and major bleeding at 1-year follow-up was 10% and 2.2%, respectively, with no difference between NSTEMI and STEMI patients. CONCLUSION: In this real-world study, a tailored evaluation of an invasive strategy and antithrombotic therapy resulted in a low rate of adverse events in elderly patients hospitalized with acute myocardial infarction.

Synthetic grafts for anterior cruciate ligament reconstruction.

Several artificial biomaterials are available as ligament grafts. No ideal prosthesis mimicking natural human tissue have been found to date. The emerging field of tissue engineering holds the promise to use artificial ligaments as a viable alternative to the patellar or hamstring tendon autografts. Preliminary studies support the idea that these biomaterials have the ability to provide an alternative for autogenous grafts. However, no definitive conclusions have been found. Additionally, the incidence of postoperative complications varies within different studies. Prospective investigations are required to better understand the potential of artificial biomaterials as ligament grafts.

Biological strategies to enhance rotator cuff healing.

Rotator cuff tear causes a high rate of morbidity. After surgical repair, the presence of a scar tissue reduces tendon biomechanical properties. Emerging strategies for enhancing tendon healing are growth factors, cytokines, gene therapy and tissue engineering. However their efficacy has to be proved. Growth factors help the process of tendon healing by aiding cells chemotaxis, differentiation and proliferation. Numerous growth factors, including the bone morphogenetic proteins and platelet-derived growth factor can be found during the early healing process of a rotator cuff repair. Growth factors are delivered to the repair site using tissue-engineered scaffolding, coated sutures, or dissolved in a fibrin sealant. Platelet-rich plasma is an autologous concentration of platelets and contains an high density of growth factors. There is some evidence that platelet-rich plasma may improve pain and recovery of function in a short time period, but it does not improve healing rates in rotator cuff. Thus the routine use of platelet-rich plasma in rotator cuff repair is not recommended. The addition of mesenchymal stem cells to scaffolds can lead to the production of a better quality healing tissue. Gene therapy is a gene transfer from a cell into another, in order to over-express the gene required. In this way, cultures of stem cells can over-express growth factors. Better understanding of the mechanisms of physiological tendon healing can promote the correct use of these new biological therapies for a better healing tissue.