Publications by authors named "Francesco Costa"

199 Publications

Establishing a national HTA program for medical devices in Italy: Overhauling a fragmented system to ensure value and equal access to new medical technologies.

Health Policy 2021 Mar 27. Epub 2021 Mar 27.

Drugs and Medical Devices, Ministry of Health, Via Ribotta 5, 00144 Rome (Italy).

Differing contexts have greatly influenced HTA development in various countries, with considerable effort recently made by international HTA networks (e.g., EUnetHTA) and the European Union (EU) to make HTA a more coherent, equal, and efficient process. Medical devices (MDs) present particular challenges for HTA because of frequent, rapid innovation, outcomes influenced by end-user competence, dynamic pricing and often low-quality scientific evidence. Our objective is to describe the development, structure and governance of a National HTA Program for MDs (PNHTADM) in Italy, a highly participatory, stakeholder-engaged, evidence-based process to reform a fragmented system of appraisal and approval. Based largely on EUnetHTA methods, the resulting process delineates a standardized system for proposing MDs by any stakeholders, accrediting HTA producers, setting criteria for prioritization and appraisals, and innovatively linking recommendations with coverage, reimbursement and procurement of MDs. Expected benefits include reduced disparities in pricing and reimbursement policies and improved access to new technologies across 21 regional healthcare systems in Italy's decentralized, universal system, complete with provisions to require additional evidence collection and centrally monitor diffusion. Though devised for Italy, the design, resources and underlying analysis provide a framework for other nations seeking to consolidate HTA initiatives, particularly in light of new EU regulation.
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http://dx.doi.org/10.1016/j.healthpol.2021.03.003DOI Listing
March 2021

Fibrosis after Myocardial Infarction: An Overview on Cellular Processes, Molecular Pathways, Clinical Evaluation and Prognostic Value.

Med Sci (Basel) 2021 Mar 1;9(1). Epub 2021 Mar 1.

Department of Clinical and Experimental Medicine, Policlinic "G. Martino", University of Messina, 98100 Messina, Italy.

The ischemic injury caused by myocardial infarction activates a complex healing process wherein a powerful inflammatory response and a reparative phase follow and balance each other. An intricate network of mediators finely orchestrate a large variety of cellular subtypes throughout molecular signaling pathways that determine the intensity and duration of each phase. At the end of this process, the necrotic tissue is replaced with a fibrotic scar whose quality strictly depends on the delicate balance resulting from the interaction between multiple actors involved in fibrogenesis. An inflammatory or reparative dysregulation, both in term of excess and deficiency, may cause ventricular dysfunction and life-threatening arrhythmias that heavily affect clinical outcome. This review discusses cellular process and molecular signaling pathways that determine fibrosis and the imaging technique that can characterize the clinical impact of this process in-vivo.
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http://dx.doi.org/10.3390/medsci9010016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7931027PMC
March 2021

Role of Adenosine and Purinergic Receptors in Myocardial Infarction: Focus on Different Signal Transduction Pathways.

Biomedicines 2021 Feb 18;9(2). Epub 2021 Feb 18.

Department of Clinical and Experimental Medicine, University of Messina, 98165 Messina, Italy.

Myocardial infarction (MI) is a dramatic event often caused by atherosclerotic plaque erosion or rupture and subsequent thrombotic occlusion of a coronary vessel. The low supply of oxygen and nutrients in the infarcted area may result in cardiomyocytes necrosis, replacement of intact myocardium with non-contractile fibrous tissue and left ventricular (LV) function impairment if blood flow is not quickly restored. In this review, we summarized the possible correlation between adenosine system, purinergic system and Wnt/β-catenin pathway and their role in the pathogenesis of cardiac damage following MI. In this context, several pathways are involved and, in particular, the adenosine receptors system shows different interactions between its members and purinergic receptors: their modulation might be effective not only for a normal functional recovery but also for the treatment of heart diseases, thus avoiding fibrosis, reducing infarcted area and limiting scaring. Similarly, it has been shown that Wnt/β catenin pathway is activated following myocardial injury and its unbalanced activation might promote cardiac fibrosis and, consequently, LV systolic function impairment. In this regard, the therapeutic benefits of Wnt inhibitors use were highlighted, thus demonstrating that Wnt/β-catenin pathway might be considered as a therapeutic target to prevent adverse LV remodeling and heart failure following MI.
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http://dx.doi.org/10.3390/biomedicines9020204DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7922652PMC
February 2021

Effectiveness and Safety of Nonmedical Switch From Adalimumab Originator to SB5 Biosimilar in Patients With Inflammatory Bowel Diseases: Twelve-Month Follow-Up From the TABLET Registry.

Inflamm Bowel Dis 2021 Feb 11. Epub 2021 Feb 11.

Department of General Surgery-Gastrointestinal Unit, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.

Background: Few data are currently available about SB5 in inflammatory bowel diseases (IBD). The aim of this study was to assess the effectiveness and safety of SB5 in a cohort of patients with IBD in stable remission switched from the adalimumab (ADA) originator and in a cohort of patients with IBD naïve to ADA.

Methods: We prospectively enrolled patients with IBD who started ADA treatment with SB5 (naïve cohort) and those who underwent a nonmedical switch from the ADA originator to SB5 (switching cohort). Clinical remission and safety were assessed at baseline and at 3, 6, and 12 months. In addition, in a small cohort of patients who were switched, we assessed the ADA serum trough levels and antidrug antibodies at baseline, 3, and 6 months.

Results: In the naïve cohort, the overall remission rate at 12 months was 60.42%, whereas in the switching cohort it was 89.02%. Fifty-three (36.3%) patients experienced an adverse event, and injection site pain was the most common; it was significantly more frequent in the switching cohort (P = 0.001). No differences were found in terms of ADA serum trough levels at baseline, 3, and 6 months after switching. No patient developed antidrug antibodies after the switch.

Conclusions: We found that SB5 seemed effective and safe in IBD, both in the naïve cohort and in the switching cohort. Further studies are needed to confirm these data in terms of mucosal healing.
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http://dx.doi.org/10.1093/ibd/izab027DOI Listing
February 2021

Early Management of Spinal Cord Injury: WFNS Spine Committee Recommendations.

Neurospine 2020 Dec 31;17(4):759-784. Epub 2020 Dec 31.

Department of Neurosurgery, Ege University, Izmir, Turkey.

Scientific knowledge today is being generated more rapidly than we can assimilate thus requiring continuous review of gold-standards for diagnosis and treatment of specific pathologies. The aim of this paper is to provide an update on the best early management of spinal cord injury (SCI), in order to produce acceptable worldwide recommendations to standardize clinical practice as much as possible.The WFNS Spine Committee voted recommendations regarding management of SCI based on literature review of the last 10 years. The committee stated 9 recommendations on 3 main topics: (1) clinical assessment and classification of SCI; (2) emergency care and early management; (3) cardiopulmonary management. American Spinal Injury Association impairment scale, Spinal Cord Independence Measure, and International Spinal Cord Injury Basic Pain Data Set are considered the most useful and feasible in emergency evaluation and follow-up in case of SCI. Magnetic resonance imaging is the most indicated examination to evaluate patients with symptomatic SCI. In early phase, correction of hypotension (systolic blood pressure < 90 mmHg), and bradycardia are strongly recommended. Surgical decompression should be performed as soon as possible with the ideal surgical time being within 8 hours for both complete and incomplete lesions.
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http://dx.doi.org/10.14245/ns.2040366.183DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7788427PMC
December 2020

Editorial: can serum triiodothyronine-to-thyroxine (T3/T4) ratio predict safety and efficacy of biologic treatment in IBD? Authors' reply.

Aliment Pharmacol Ther 2021 01;53(2):348-349

Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

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http://dx.doi.org/10.1111/apt.16213DOI Listing
January 2021

Is Gluten the Only Culprit for Non-Celiac Gluten/Wheat Sensitivity?

Nutrients 2020 Dec 10;12(12). Epub 2020 Dec 10.

Gastrointestinal Unit, Department of Translational Sciences and New Technologies in Medicine and Surgery, University of Pisa, 56124 Pisa, Italy.

The gluten-free diet (GFD) has gained increasing popularity in recent years, supported by marketing campaigns, media messages and social networks. Nevertheless, real knowledge of gluten and GF-related implications for health is still poor among the general population. The GFD has also been suggested for non-celiac gluten/wheat sensitivity (NCG/WS), a clinical entity characterized by intestinal and extraintestinal symptoms induced by gluten ingestion in the absence of celiac disease (CD) or wheat allergy (WA). NCG/WS should be regarded as an "umbrella term" including a variety of different conditions where gluten is likely not the only factor responsible for triggering symptoms. Other compounds aside from gluten may be involved in the pathogenesis of NCG/WS. These include fructans, which are part of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs), amylase trypsin inhibitors (ATIs), wheat germ agglutinin (WGA) and glyphosate. The GFD might be an appropriate dietary approach for patients with self-reported gluten/wheat-dependent symptoms. A low-FODMAP diet (LFD) should be the first dietary option for patients referring symptoms more related to FODMAPs than gluten/wheat and the second-line treatment for those with self-reported gluten/wheat-related symptoms not responding to the GFD. A personalized approach, regular follow-up and the help of a skilled dietician are mandatory.
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http://dx.doi.org/10.3390/nu12123785DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7762999PMC
December 2020

Transfusion and Mortality After Transcatheter Aortic Valve Replacement: Association or Causation?

Circ Cardiovasc Interv 2020 Dec 4;13(12):e010225. Epub 2020 Dec 4.

Cardiovascular Division, Department of Medicine, University of Miami Miller School of Medicine and the Elaine and Sydney Sussman Cardiac Catheterization Laboratory, University of Miami Hospitals and Clinics, FL (M.G.C.).

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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.010225DOI Listing
December 2020

Long-term outcomes of acute severe ulcerative colitis in the rescue therapy era: A multicentre cohort study.

United European Gastroenterol J 2020 Dec 1:2050640620977405. Epub 2020 Dec 1.

IBD Unit, San Filippo Neri Hospital, Rome, Italy.

Background: The long-term course of ulcerative colitis after a severe attack is poorly understood. Second-line rescue therapy with cyclosporine or infliximab is effective for reducing short-term colectomy but the impact in the long-term is controversial.

Objective: The purpose of this study was to evaluate the long-term course of acute severe ulcerative colitis patients who avoid early colectomy either because of response to steroids or rescue therapy.

Methods: This was a multicentre retrospective cohort study of adult patients with acute severe ulcerative colitis admitted to Italian inflammatory bowel disease referral centres from 2005-2017. All patients received intravenous steroids, and those who did not respond received either rescue therapy or colectomy. For patients who avoided early colectomy (within three months from the index attack), we recorded the date of colectomy, last follow-up visit or death. The primary end-point was long-term colectomy rate in patients avoiding early colectomy.

Results: From the included 372 patients with acute severe ulcerative colitis, 337 (90.6%) avoided early colectomy. From those, 60.5% were responsive to steroids and 39.5% to the rescue therapy. Median follow-up was 44 months (interquartile range, 21-85). Colectomy-free survival probability was 93.5%, 81.5% and 79.4% at one, three and five years, respectively. Colectomy risk was higher among rescue therapy users than in steroid-responders (log-rank test,  = 0.02). At multivariate analysis response to steroids was independently associated with a lower risk of long-term colectomy (adjusted odds ratio = 0.5; 95% confidence interval, 0.2-0.8), while previous exposure to anti-tumour necrosis factor alpha agents was associated with an increased risk (adjusted odds ratio = 3.0; 95% confidence interval, 1.5-5.7). Approximately 50% of patients required additional therapy or new hospitalization within five years due to a recurrent flare. Death occurred in three patients (0.9%).

Conclusions: Patients with acute severe ulcerative colitis avoiding early colectomy are at risk of long-term colectomy, especially if previously exposed to anti-tumour necrosis factor alpha agents or if rescue therapy during the acute attack was required because of steroid refractoriness.
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http://dx.doi.org/10.1177/2050640620977405DOI Listing
December 2020

Antithrombotic therapy according to baseline bleeding risk in patients with atrial fibrillation undergoing percutaneous coronary intervention: applying the PRECISE-DAPT score in RE-DUAL PCI.

Eur Heart J Cardiovasc Pharmacother 2020 Dec 1. Epub 2020 Dec 1.

Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA, USA.

Aims: Patients with atrial fibrillation undergoing coronary intervention are at higher bleeding risk due to the concomitant need for oral anticoagulation and antiplatelet therapy. The RE-DUAL PCI trial demonstrated better safety with dual antithrombotic therapy (DAT: dabigatran 110 or 150 mg bid, clopidogrel or ticagrelor) compared to triple antithrombotic therapy (TAT: warfarin, clopidogrel or ticagrelor, and aspirin). We explored the impact of baseline bleeding risk based on the PRECISE-DAPT score for decision-making regarding DAT vs. TAT.

Methods And Results: A score ≥25 points qualified high bleeding-risk (HBR). Comparisons were made for the primary safety endpoint ISTH major or clinically relevant non-major bleeding, and the composite efficacy endpoint of death, thromboembolic events, or unplanned revascularization, analyzed by time-to-event analysis. PRECISE-DAPT was available in 2,336/2,725 patients, and 37.9% were HBR. Compared to TAT, DAT with dabigatran 110 mg reduced bleeding risk both in non-HBR (HR 0.42, 95%CI, 0.31-0.57) and HBR (HR 0.70, 95%CI, 0.52-0.94), with a greater magnitude of benefit among non-HBR (Pint=0.02). DAT with dabigatran 150 mg vs. TAT reduced bleeding in non-HBR (HR 0.60, 95%CI, 0.45-0.80), with a trend toward less benefit in HBR patients (HR 0.92, 95%CI, 0.63-1.34, Pint=0.08). Risk of ischaemic events was similar on DAT with dabigatran (both 110 and 150 mg) vs. TAT in non-HBR and HBR patients (Pint=0.45 and Pint=0.56, respectively).

Conclusions: PRECISE-DAPT score appeared useful to identify AF patients undergoing PCI at further increased risk of bleeding complications, and may help clinicians identifying the antithrombotic regimen intensity with the best benefit-risk ratio in an individual patient.
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http://dx.doi.org/10.1093/ehjcvp/pvaa135DOI Listing
December 2020

Serum triiodothyronine-to-thyroxine (T3/T4) ratio predicts therapeutic outcome to biological therapies in elderly IBD patients.

Aliment Pharmacol Ther 2021 01 18;53(2):273-280. Epub 2020 Nov 18.

IBD Unit, Department of General Surgery and Gastroenterology, Pisa University Hospital, Pisa, Italy.

Introduction: Rates of elderly patients with inflammatory bowel diseases (IBDs) are increasing, and biomarkers are needed to optimise their therapies. Serum triiodothyronine-to-thyroxine (T3/T4) ratio has been correlated with geriatric patient frailty.

Aim: To assess the suitability of T3/T4 ratio as a response marker to biologics in elderly patients with IBD.

Methods: Patients with IBD over 60 years old were enrolled, when starting biological therapy. Therapeutic outcome was assessed after 54 weeks of treatment as mucosal healing (Mayo endoscopic score < 2 for ulcerative colitis; ulcer disappearance for Crohn's disease) and clinical remission (Partial Mayo Score < 2 for ulcerative colitis; Harvey-Bradshaw Index < 5 for Crohn's disease). T3/T4 ratio was evaluated at baseline, and its association with therapeutic outcomes was tested by multivariable logistic regression and receiver operating characteristic (ROC).

Results: We enrolled 80 patients; 44 achieved clinical remission and 36 mucosal healing. Baseline T3/T4 ratio was higher in patients with mucosal healing, as compared with those without mucosal healing (P < 0.0001), regardless of the disease type or biological drug (OR 6.4 [2.9-14.3] for each T3/T4 unit increase, P < 0.0001). A cut point of 3.3 was identified as the optimal threshold of baseline T3/T4 ratio for predicting mucosal healing, providing 78% sensitivity and 89% specificity (area under the ROC curve 0.88 [0.79-0.94]; positive and negative likelihood ratios 6.8 [2.9-15.9] and 0.3 [0.1-0.5] respectively).

Conclusions: T3/T4 ratio seems a reliable tool for predicting therapeutic outcome of biological therapy in elderly patients with IBD. If validated, the assessment of this parameter before starting biological treatment might be suggested.
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http://dx.doi.org/10.1111/apt.16167DOI Listing
January 2021

Low Fermentable Oligo- Di- and Mono-Saccharides and Polyols (FODMAPs) or Gluten Free Diet: What Is Best for Irritable Bowel Syndrome?

Nutrients 2020 Nov 1;12(11). Epub 2020 Nov 1.

Clinical and Experimental Medicine-Rheumatology Unit, University of Pisa, 56100 Pisa, Italy.

Irritable Bowel Syndrome (IBS) is a very common functional gastrointestinal disease. Its pathogenesis is multifactorial and not yet clearly defined, and hence, its therapy mainly relies on symptomatic treatments. Changes in lifestyle and dietary behavior are usually the first step, but unfortunately, there is little high-quality scientific evidence regarding a dietary approach. This is due to the difficulty in setting up randomized double-blind controlled trials which objectively evaluate efficacy without the risk of a placebo effect. However, a Low Fermentable Oligo-, Di- and Mono-saccharides And Polyols (FODMAP) Diet (LFD) and Gluten Free Diet (GFD) are among the most frequently suggested diets. This paper aims to evaluate their possible role in IBS management. A GFD is less restrictive and easier to implement in everyday life and can be suggested for patients who clearly recognize gluten as a trigger of their symptoms. An LFD, being more restrictive and less easy to learn and to follow, needs the close supervision of a skilled nutritionist and should be reserved for patients who recognize that the trigger of their symptoms is not, or not only, gluten. Even if the evidence is of very low-quality for both diets, the LFD is the most effective among the dietary interventions suggested for treating IBS, and it is included in the most updated guidelines.
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http://dx.doi.org/10.3390/nu12113368DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7692077PMC
November 2020

Switching from IFX originator to biosimilar CT-P13 does not impact effectiveness,safety and immunogenicity in a large cohort of IBD patients.

Expert Opin Biol Ther 2021 Jan 31;21(1):97-104. Epub 2020 Oct 31.

CEMAD - IBD UNIT - Unità Operativa Complessa di Medicina Interna e Gastroenterologia, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario "A. Gemelli" IRCCS , Rome, Italy.

Background: Switching from IFX originator to CT-P13 is safe; however, little data on immunogenicity exists.

Research Design And Methods: Consecutive IBD patients on IFX originator were switched to CT-P13 and followed-up for 12 months. Clinical activity, infliximab trough levels (ITLs), anti-drug antibodies (ATIs), and adverse events were recorded at predefined timepoints (baseline, second CT-P13 infusion, 6 and 12 months). The outcomes investigated were immunogenicity, pharmacokinetics, effectiveness and safety.

Results: 119 patients were switched to CT-P13 after a median time with IFX of 5.8 years. No changes in mean ITLs were observed. ATIs were detected in 30 patients (25.2%): 14 before and 16 after switch. Mean persistent ATIs were significantly higher compared to mean transient ones (109.74 ng/mL ±84.70 vs 18.22 ng/mL ±11.37, p < 0.001), with significantly lower ITLs associated (mean 0.32 µg/mL ±0.6 vs 3.08 µg/mL ±3.22, p < 0.001). A significant decrease of patients in steroid-fee clinical remission was observed after the switch (p = 0.004), with subsequent improvement at 6 months (p = 0.005). Eighteen patients (15.1%) discontinued IFX, only 6 (5%) for loss of response.

Conclusions: Switching from infliximab originator to CT-P13 seems safe and effective, without differences in immunogenicity. A temporary reduction of clinical benefit after switching could be potentially explained by a 'nocebo-effect response'.
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http://dx.doi.org/10.1080/14712598.2020.1839045DOI Listing
January 2021

The High Bleeding Risk Patient with Coronary Artery Disease.

Cardiol Clin 2020 Nov 17;38(4):481-490. Epub 2020 Sep 17.

Department of Clinical and Experimental Medicine, Policlinico "G. Martino", University of Messina, Via C Valeria 1, Messina 98100, Italy.

Out-of-hospital bleeding is a common complication after percutaneous coronary intervention (PCI) due to the concomitant need for dual antiplatelet therapy. A significant proportion of patients undergoing PCI carry specific clinical characteristics posing them at high bleeding risk (HBR), increasing the risk of hemorrhagic complications secondary to antithrombotic therapy. Identifying patients at HBR and adjust antithrombotic therapy accordingly to optimize treatment benefits and risk is a challenge of modern cardiology. Recently, multiple definitions and tools have been provided to help clinicians with prognostic stratification and treatment decision making in this subgroup.
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http://dx.doi.org/10.1016/j.ccl.2020.06.002DOI Listing
November 2020

Voluminous schwannoma type 'ancient' of the cervicothoracic district removed through a cervicotomic approach.

J Surg Case Rep 2020 Sep 30;2020(9):rjaa402. Epub 2020 Sep 30.

Department of Surgery, University of Milan, Milano, Italy.

Schwannomas are generally benign tumors, well delimited, resulting from nerve sheaths that are frequently found in the thorax, mainly in the posterior mediastinum. We report a 58-year-old patient who carried out investigations following the appearance of a large right supraclavicular cervical mass associated with anisocoria and eyelid ptosis, histologically diagnosed as ancient schwannoma, completely removed through a cervicotomic approach without opening the chest.
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http://dx.doi.org/10.1093/jscr/rjaa402DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7524608PMC
September 2020

Degenerative Lumbar Spine Stenosis Consensus Conference: the Italian Job. Recommendations of the Spinal Section of Italian Society of Neurosurgery.

J Neurosurg Sci 2020 Sep 24. Epub 2020 Sep 24.

Neurosurgical Unit of San Giovanni Bosco Hospital, Naples, Italy.

Background: In the modern era evidence-based medicine, guidelines and recommendations represent a key-point of daily activity. The Spinal Section of the Italian Society of Neurosurgery introduced some recommendations regarding Degenerative Lumbar Spine Stenosis based on those of the Spine Committee of World Federation of Neurosurgical Societies, revising them on the basis of Italian common practice.

Methods: In June 2019, a Committee of 21 spine surgeons met in Rome to validate the recommendations of the WFNS. Furthermore, they decided to review the ones that did not reach a consensus to create Italian Recommendations on Degenerative Lumbar Spine Stenosis. A literature review of the last ten years was performed and the statements were voted using the Delphi method.

Results: 41 statements were discussed and 7 statements were voted again to reach a consensus with respect to those of the WFNS. A total of 40 statements reached a consensus, of which 36 reached a positive consensus and 4 a negative consensus, while no consensus was reached in 1 case.

Conclusions: Conservative multimodal therapy, tailored on the patient, is a reasonable and effective first option choice for the treatment of LSS patients with tolerable moderate symptoms. Surgical treatment is reserved for symptomatic patients non-responding to conservative treatment or with neurological deficits. The best surgical technique to use depends on personal experience; modern MISS techniques are equivalent to open decompressive surgery with some advantages and higher cost-effectiveness. Fusion surgery and mobility preserving surgery only have a marginal role in the treatment of DLSS without instability.
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http://dx.doi.org/10.23736/S0390-5616.20.05042-0DOI Listing
September 2020

The Microfluidic Trainer: Design, Fabrication and Validation of a Tool for Testing and Improving Manual Skills.

Micromachines (Basel) 2020 Sep 19;11(9). Epub 2020 Sep 19.

BST Biomedical Science and Technologies Lab, IRCCS Istituto Ortopedico Rizzoli, 40126 Bologna, Italy.

Microfluidic principles have been widely applied for more than 30 years to solve biological and micro-electromechanical problems. Despite the numerous advantages, microfluidic devices are difficult to manage as their handling comes with several technical challenges. We developed a new portable tool, the microfluidic trainer (MT), that assesses the operator handling skills and that may be used for maintaining or improving the ability to inject fluid in the inlet of microfluidic devices for in vitro cell culture applications. After several tests, we optimized the MT tester cell to reproduce the real technical challenges of a microfluidic device. In addition to an exercise path, we included an overfilling indicator and a correct infilling indicator at the inlet (control path). We manufactured the MT by engraving a 3 mm-high sheet of methacrylate with 60W CO laser plotter to create multiple capillary paths. We validated the device by enrolling 21 volunteers (median age 33) to fill both the MT and a commercial microfluidic device. The success rate obtained with MT significantly correlated with those of a commercial microfluidic culture plate, and its 30 min-continuous use for three times significantly improved the performance. Overall, our data demonstrate that MT is a valid assessment tool of individual performances in using microfluidic devices and may represent a low-cost solution to training, improve or warm up microfluidic handling skills.
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http://dx.doi.org/10.3390/mi11090872DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7570042PMC
September 2020

Antithrombotic Therapy after Percutaneous Coronary Intervention of Bifurcation Lesions.

EuroIntervention 2020 Sep 15. Epub 2020 Sep 15.

Institute of Cardiology, University "G. d'Annuzio" of Chieti-Pescara, Italy.

Coronary bifurcations exhibit localized turbulent flow and enhanced propensity for platelet deposition, plaque rupture, and atherothrombosis. Percutaneous coronary intervention (PCI) of bifurcation lesions is associated with an increased risk of thrombotic events. Such risk is modulated by anatomical complexity, intraprocedural factors and pharmacological therapy. There is no consensus on the appropriate PCI strategy or the optimal regimen and duration of antithrombotic treatment in order to decrease the risk of ischemic and bleeding complications in the setting of coronary bifurcation. A uniform therapeutic approach meets a clinical need. The present initiative, promoted by the European Bifurcation Club (EBC), involves opinion leaders from Europe, America, and Asia with the aim to analyze the currently available evidence. Although mainly derived from sub-studies of large trials or small studies, or from authors' opinions, an algorithm for the optimal management of patients undergoing bifurcation PCI, developed on the basis of clinical presentation, bleeding risk, and intraprocedural strategy is here proposed.
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http://dx.doi.org/10.4244/EIJ-D-20-00885DOI Listing
September 2020

Myocardial ischemia due to a recanalized chronic coronary thrombus: Angiographic and optical coherence tomography imaging insights.

Clin Case Rep 2020 Aug 24;8(8):1582-1583. Epub 2020 Jun 24.

Interventional Cardiology Unit Umberto I Hospital Syracuse Italy.

Chronic organized thrombus as a result of prior untreated myocardial infarction can determine myocardial ischemia. This entity appears as an angiographically irregular and hazy image; optical coherence tomography is useful to evaluate these ambiguous lesions and guide interventional treatment.
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http://dx.doi.org/10.1002/ccr3.2909DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7455434PMC
August 2020

Long-Term Bleeding Risk Prediction with Dual Antiplatelet Therapy After Acute Coronary Syndromes Treated Without Revascularization.

Circ Cardiovasc Qual Outcomes 2020 09 31;13(9):e006582. Epub 2020 Aug 31.

Duke Clinical Research Institute, Durham, NC (G.M.G., M.L.N., R.A., E.M.O., M.T.R.).

Background: Longitudinal bleeding risk scores have been validated in patients treated with dual antiplatelet therapy (DAPT) following percutaneous coronary intervention. How these scores apply to the population of patients with acute coronary syndrome (ACS) treated without revascularization remains unknown. The objective was to evaluate and compare the performances of the PRECISE-DAPT, PARIS, and DAPT (bleeding component) bleeding risk scores in the medically managed patients with ACS treated with DAPT.

Methods And Results: TRILOGY ACS (Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes) was a double-blind, placebo-controlled randomized trial conducted from 2008 to 2012 over a median follow-up of 17.0 months in 966 sites (52 countries). High-risk patients with unstable angina or non-ST-segment-elevation myocardial infarction who did not undergo revascularization were randomized to prasugrel or clopidogrel. The PRECISE-DAPT, PARIS, and DAPT (bleeding component) risk scores were applied in the TRILOGY ACS population to evaluate their performance to predict adjudicated non-coronary artery bypass grafting-related GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) severe/life-threatening/moderate and TIMI (Thrombolysis in Myocardial Infarction) major/minor bleeding with time-dependent c-indices. Among the 9326 participants, median age was 66 years (interquartile range, 59-74 years), and 3650 were females (39.1%). A total of 158 (1.69%) GUSTO severe/life-threatening/moderate and 174 (1.87%) TIMI major/minor non-coronary artery bypass grafting bleeding events occurred. The c-indices (95% CI) of the PRECISE-DAPT, PARIS, and DAPT (bleeding component) scores through 12 months were 0.716 (0.677-0.758), 0.693 (0.658-0.733), and 0.674 (0.637-0.713), respectively, for GUSTO bleeding and 0.624 (0.582-0.666), 0.612 (0.578-0.651), and 0.608 (0.571-0.649), respectively, for TIMI bleeding. There was no significant difference in the c-indices of each score based upon pairwise comparisons.

Conclusions: Among medically managed patients with ACS treated with DAPT, the performances of the PRECISE-DAPT, PARIS, and DAPT (bleeding component) scores were reasonable and similar to their performances in the derivation percutaneous coronary intervention populations. Bleeding risk scores may be used to predict longitudinal bleeding risk in patients with ACS treated with DAPT without revascularization and help support shared decision making. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00699998.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.006582DOI Listing
September 2020

Antithrombotic strategies in patients needing oral anticoagulation undergoing percutaneous coronary intervention: A network meta-analysis.

Catheter Cardiovasc Interv 2021 Mar 13;97(4):581-588. Epub 2020 Aug 13.

Division of Cardiology, Department of Medical Science, University of Turin, Turin, Italy.

Background: The optimal antithrombotic regimen in patients with a concomitant indication for oral anticoagulation (OAT) presenting with acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI) remains unclear.

Objectives: To perform a network meta-analysis of all randomized controlled trials (RCTs) evaluating different antithrombotic regimens among patients with ACS or undergoing PCI requiring OAT.

Methods: Network meta-analysis was performed in a frequentist framework. Antithrombotic regimens were categorized by OAC type (vitamin K antagonist-based [VKA]; non-VKA OAT [NOAC]) and antiplatelet agents (P2Y inhibitor only: dual therapy [DAT]; P2Y plus aspirin: triple therapy [TAT]). Safety outcomes were Thrombolysis in Myocardial Infarction (TIMI) major bleeding and intracranial hemorrhage (ICH). Efficacy outcomes were cardiovascular death, myocardial infarction, stroke and stent-thrombosis (ST).

Results: Five RCTs were included, encompassing 10,797 patients (atrial fibrillation 69-100%, ACS 28-62%, PCI 77-100%). Both VKA and NOAC-based DAT regimens reduced the occurrence of TIMI major bleeding compared to VKA TAT (VKA DAT: RR 0.62, 95% CI 0.39-0.98; NOAC DAT: RR 0.52, 95% CI 0.39-0.70). Nevertheless, only NOAC DAT significantly reduced the occurrence of ICH compared to VKA TAT (RR 0.33, 95% CI 0.17-0.64). Ischemic outcomes were similar among the four treatment regimens. However, numerical, potentially clinically important, higher ST occurrence was observed for NOAC DAT as compared to both VKA TAT (1.50, 95% confidence interval [CI] 0.96-2.33) and NOAC TAT (1.86, 95% CI 0.93-3.73).

Conclusion: DAT regimens present the highest safety profile among antithrombotic strategies, with a NOAC-specific impact on ICH reduction. NOAC DAT might entail clinically important higher ST occurrence, warranting a case-by-case comprehensive evaluation that integrates patient- and procedure-related residual ischemic risk with the patient-specific bleeding risk.
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http://dx.doi.org/10.1002/ccd.29192DOI Listing
March 2021

A Low-FODMAP Diet for Irritable Bowel Syndrome: Some Answers to the Doubts from a Long-Term Follow-Up.

Nutrients 2020 Aug 7;12(8). Epub 2020 Aug 7.

Clinical and Experimental Medicine-Rheumatology Unit, University of Pisa, 56100 Pisa, Italy.

A low-FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diet (LFD) is a possible therapy for irritable bowel syndrome (IBS). This study investigates the short- and long-term efficacy and nutritional adequacy of an LFD and the patients' long-term acceptability. Patients' adherence and ability to perceive the "trigger" foods were also evaluated. Seventy-three IBS patients were given an LFD (T0) and after 2 months (T1), 68 started the reintroduction phase. At the end of this period (T2), 59 were advised to go on an Adapted Low-FODMAP Diet (AdLFD) and 41 were evaluated again after a 6-24 month follow-up (T3). At each time, questionnaires and Biolectrical Impedance Vector Analysis (BIVA) were performed. The LFD was effective in controlling digestive symptoms both in the short- and long-term, and in improving quality of life, anxiety and depression, even if some problems regarding acceptability were reported and adherence decreased in the long term. The LFD improved the food-related quality of life without affecting nutritional adequacy. When data collected at T0 were compared with those collected at T2, the perception of trigger foods was quite different. Even if some problems of acceptability and adherence are reported, an LFD is nutritionally adequate and effective in improving IBS symptoms also in the long term.
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http://dx.doi.org/10.3390/nu12082360DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7468924PMC
August 2020

Fecal Calprotectin Predicts Mucosal Healing in Patients With Ulcerative Colitis Treated With Biological Therapies: A Prospective Study.

Clin Transl Gastroenterol 2020 05;11(5):e00174

IBD Unit, Department of General Surgery and Gastroenterology, Pisa University Hospital, Pisa, Italy.

Introduction: Biological therapies are widely used for the treatment of ulcerative colitis. However, only a low proportion of patients achieve clinical remission and even less mucosal healing. There is currently scarce knowledge about the early markers of therapeutic response, with particular regard to mucosal healing. The aim of this prospective study was to evaluate the role of fecal calprotectin (FC) as early predictor of mucosal healing.

Methods: A prospective observational study was conducted on patients with ulcerative colitis, who started biological therapy with infliximab, adalimumab, golimumab, or vedolizumab at our center. All patients underwent colonoscopy, performed by 2 blinded operators, at baseline and week 54 or in case of therapy discontinuation because of loss of response. FC was assessed at baseline and week 8 and evaluated as putative predictor of mucosal healing at week 54.

Results: We enrolled 109 patients, and 97 were included in the analysis. Twenty-six patients (27%) experienced loss of response. Over 71 patients (73%) with clinical response at week 54, clinical remission was obtained in 60 patients (61.9%) and mucosal healing in 45 patients (46.4%). After 8 weeks of treatment, FC predicted mucosal healing at week 54 (P < 0.0001). Sensitivity, specificity, positive predictive value, and negative predictive value were estimated to be 75%, 88.9%, 86.6%, and 75.5%, respectively, based on a cutoff of 157.5 mg/kg.

Discussion: The present study suggests that FC assessment after 8 weeks of treatment with all the biological drugs could represent a promising early marker of response to therapy in terms of mucosal healing.
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http://dx.doi.org/10.14309/ctg.0000000000000174DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7263645PMC
May 2020

Guidelines in the modern era.

J Neurosurg Sci 2021 Feb 2;65(1):88-89. Epub 2020 Jul 2.

Department of Neurosurgery, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy.

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http://dx.doi.org/10.23736/S0390-5616.20.05039-0DOI Listing
February 2021

Conservative Treatment and Percutaneous Pain Relief Techniques in Patients with Lumbar Spinal Stenosis: WFNS Spine Committee Recommendations.

World Neurosurg X 2020 Jul 23;7:100079. Epub 2020 Jun 23.

Neurosurgery Department, Humanitas Research Hospital, Rozzano, Milan, Italy.

Background: Degenerative lumbar spinal stenosis (LSS) is a progressive disease with potentially dangerous consequences that affect quality of life. Despite the detailed literature, natural history is unpredictable. This uncertainty presents a challenge making the correct management decisions, especially in patients with mild to moderate symptoms, regarding conservative or surgical treatment. This article focused on conservative treatment for degenerative LSS.

Methods: To standardize clinical practice worldwide as much as possible, the World Federation of Neurosurgical Societies Spine Committee held a consensus conference on conservative treatment for degenerative LSS. A team of experts in spinal disorders reviewed the literature on conservative treatment for degenerative LSS from 2008 to 2018 and drafted and voted on a number of statements.

Results: During 2 consensus meetings, 14 statements were voted on. The Committee agreed on the use of physical therapy for up to 3 months in cases with no neurologic symptoms. Initial conservative treatment could be applied without major complications in these cases. In patients with moderate to severe symptoms or with acute radicular deficits, surgical treatment is indicated. The efficacy of epidural injections is still debated, as it shows only limited benefit in patients with degenerative LSS.

Conclusions: A conservative approach based on therapeutic exercise may be the first choice in patients with LSS except in the presence of significant neurologic deficits. Treatment with instrumental modalities or epidural injections is still debated. Further studies with standardization of outcome measures are needed to reach high-level evidence conclusions.
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http://dx.doi.org/10.1016/j.wnsx.2020.100079DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7322792PMC
July 2020

Mobility-Preserving Surgery for Lumbar Spinal Stenosis: WFNS Spine Committee Recommendations.

World Neurosurg X 2020 Jul 19;7:100078. Epub 2020 Mar 19.

Neurosurgery Department, Humanitas Clinical and Research Hospital, Rozzano, Milan, Italy.

Background: Although decompression is the basis of surgical treatment for lumbar spinal stenosis (LSS), under various circumstances instrumented fusion is performed as well. The rationale for mobility-preserving operations for LSS is preventing adjacent segment disease (ASD). We review the rationale for mobility preservation in ASD and discuss related topics such as indications for fusion and the evolving role of minimally invasive approaches to lumbar spine decompression. Our focus is on systematic review and consensus discussion of mobility-preserving surgical methods as related to surgery for LSS.

Methods: Groups of spinal surgeons (members of the World Federation of Neurosurgical Societies Spine Committee) performed systematic reviews of dynamic fixation systems, including hybrid constructs, and of interspinous process devices; consensus statements were generated based on the reviews at 2 voting sessions by the committee several months apart. Additional review of background data was performed, and the results summarized in this review.

Results: Decompression is the basis of surgical treatment of LSS. Fusion is an option, especially when spondylolisthesis or instability are present, but indications remain controversial. ASD incidence reports show high variability. ASD may represent the natural progression of degenerative disease in many cases. Older age, poor sagittal balance, and multilevel fusion may be associated with more ASD. Dynamic fixation constructs are treatment options that may help prevent ASD.
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http://dx.doi.org/10.1016/j.wnsx.2020.100078DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7322805PMC
July 2020