Publications by authors named "Simona Sacco"

172 Publications

Risk Factors for Intracerebral Hemorrhage in Patients With Atrial Fibrillation on Non-Vitamin K Antagonist Oral Anticoagulants for Stroke Prevention.

Authors:
Maurizio Paciaroni Giancarlo Agnelli Michela Giustozzi Valeria Caso Elisabetta Toso Filippo Angelini Isabella Canavero Giuseppe Micieli Kateryna Antonenko Alessandro Rocco Marina Diomedi Aristeidis H Katsanos Ashkan Shoamanesh Sotirios Giannopoulos Walter Ageno Samuela Pegoraro Jukka Putaala Daniel Strbian Hanne Sallinen Brian C Mac Grory Karen L Furie Christoph Stretz Michael E Reznik Andrea Alberti Michele Venti Maria Giulia Mosconi Maria Cristina Vedovati Laura Franco Giorgia Zepponi Michele Romoli Andrea Zini Laura Brancaleoni Letizia Riva Giorgio Silvestrelli Alfonso Ciccone Maria Luisa Zedde Elisa Giorli Maria Kosmidou Evangelos Ntais Lina Palaiodimou Panagiotis Halvatsiotis Tiziana Tassinari Valentina Saia Raffaele Ornello Simona Sacco Fabio Bandini Michelangelo Mancuso Giovanni Orlandi Elena Ferrari Alessandro Pezzini Loris Poli Manuel Cappellari Stefano Forlivesi Alberto Rigatelli Shadi Yaghi Erica Scher Jennifer A Frontera Luca Masotti Elisa Grifoni Pietro Caliandro Aurelia Zauli Giuseppe Reale Simona Marcheselli Antonio Gasparro Valeria Terruso Valentina Arnao Paolo Aridon Azmil H Abdul-Rahim Jesse Dawson Carlo Emanuele Saggese Francesco Palmerini Boris Doronin Vera Volodina Danilo Toni Angela Risitano Erika Schirinzi Massimo Del Sette Piergiorgio Lochner Serena Monaco Marina Mannino Rossana Tassi Francesca Guideri Maurizio Acampa Giuseppe Martini Enrico Maria Lotti Marina Padroni Leonardo Pantoni Silvia Rosa Pierluigi Bertora George Ntaios Dimitrios Sagris Antonio Baldi Cataldo D'Amore Nicola Mumoli Cesare Porta Licia Denti Alberto Chiti Francesco Corea Monica Acciarresi Yuriy Flomin Nemanja Popovic Georgios Tsivgoulis

Stroke 2021 Mar 4:STROKEAHA120031827. Epub 2021 Mar 4.

Second Department of Neurology, "Attikon" Hospital, National and Kapodistrian University of Athens, School of Medicine, Greece (L. Palaiodimou, G.T.).

Background And Purpose: Clinical trials on stroke prevention in patients with atrial fibrillation have consistently shown clinical benefit from either warfarin or non-vitamin K antagonist oral anticoagulants (NOACs). NOAC-treated patients have consistently reported to be at lower risk for intracerebral hemorrhage (ICH) than warfarin-treated patients. The aims of this prospective, multicenter, multinational, unmatched, case-control study were (1) to investigate for risk factors that could predict ICH occurring in patients with atrial fibrillation during NOAC treatment and (2) to evaluate the role of CHADS-VASc and HAS-BLED scores in the same setting.

Methods: Cases were consecutive patients with atrial fibrillation who had ICH during NOAC treatment. Controls were consecutive patients with atrial fibrillation who did not have ICH during NOAC treatment. As within the CHADS-VASc and HAS-BLED scores there are some risk factors in common, several multivariable logistic regression models were performed to identify independent prespecified predictors for ICH events.

Results: Four hundred nineteen cases (mean age, 78.8±8.1 years) and 1526 controls (mean age, 76.0±10.3 years) were included in the study. From the different models performed, independent predictors of ICH were increasing age, concomitant use of antiplatelet agents, active malignancy, high risk of fall, hyperlipidemia, low clearance of creatinine, peripheral artery disease, and white matter changes. Low doses of NOACs (given according to label or not) and congestive heart failure were inversely associated with the risk of ICH. HAS-BLED and CHADS-VASc scores performed poorly in predicting ICH with areas under the curves of 0.496 (95% CI, 0.468-0.525) and 0.530 (95% CI, 0.500-0.560), respectively.

Conclusions: Several risk factors were associated to ICH in patients treated with NOACs for stroke prevention but not HAS-BLED and CHADS-VASc scores.
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http://dx.doi.org/10.1161/STROKEAHA.120.031827DOI Listing
March 2021

Timing of initiation of oral anticoagulants in patients with acute ischemic stroke and atrial fibrillation comparing posterior and anterior circulation strokes.

Authors:
Maurizio Paciaroni Giancarlo Agnelli Michela Giustozzi Georgios Tsivgoulis Shadi Yaghi Brian Mac Grory Karen L Furie Prasanna Tadi Marialuisa Zedde Azmil H Abdul-Rahim Jesse Dawson Kennedy R Lees Andrea Alberti Michele Venti Monica Acciarresi Cataldo D'Amore Maria Giulia Mosconi Valentina Bogini Manuel Cappellari Alberto Rigatelli Bruno Bonetti Jukka Putaala Liisa Tomppo Turgut Tatlisumak Fabio Bandini Simona Marcheselli Alessandro Pezzini Loris Poli Alessandro Padovani Luca Masotti Elisa Grifoni Vieri Vannucchi Sung-Il Sohn Gianni Lorenzini Rossana Tassi Francesca Guideri Maurizio Acampa Giuseppe Martini George Ntaios George Athanasakis Konstantinos Makaritsis Efstathia Karagkiozi Konstantinos Vadikolias Chrissoula Liantinioti Lina Palaiodimou Nicola Mumoli Cesare Porta Franco Galati Simona Sacco Cindy Tiseo Francesco Corea Walter Ageno Marta Bellesini Giorgio Silvestrelli Alfonso Ciccone Umberto Scoditti Licia Denti Michelangelo Mancuso Maria C Caselli Miriam Maccarrone Leonardo Ulivi Giovanni Orlandi Nicola Giannini Tiziana Tassinari Maria L De Lodovici Christina Rueckert Antonio Baldi Danilo Toni Luana Gentile Federica Letteri Martina Giuntini Enrico M Lotti Yuriy Flomin Alessio Pieroni Odysseas Kargiotis Theodore Karapanayiotides Serena Monaco Marina Mannino Mario M Baronello Laszló Csiba Lilla Szabó Alberto Chiti Elisa Giorli Massimo Del Sette Erika Schirinzi Davide Imberti Dorjan Zabzuni Boris Doronin Vera Volodina Patrik Michel Ashraf Eskandari Peter Vanacker Kristian Barlinn Jessica Barlinn Dirk Deleu Vanessa Gourbali Valeria Caso

Eur Stroke J 2020 Dec 22;5(4):374-383. Epub 2020 Jul 22.

Stroke Unit and Division of Cardiovascular Medicine, University of Perugia, Perugia, Italy.

Introduction: The aim of this study in patients with acute posterior ischaemic stroke (PS) and atrial fibrillation (AF) was to evaluate (1) the risks of recurrent ischaemic event and severe bleeding and (2) these risks in relation with oral anticoagulant therapy (OAT) and its timing.

Materials And Methods: Patients with PS were prospectively included; the outcome events of these patients were compared with those of patients with anterior stroke (AS) which were taken from previous registries. The primary outcome was the composite of stroke recurrence, transient ischaemic attack, symptomatic systemic embolism, symptomatic cerebral bleeding and major extracranial bleeding occurring within 90 days from acute stroke.

Results: A total of 2470 patients were available for the analysis: 473 (19.1%) with PS and 1997 (80.9%) with AS. Over 90 days, 213 (8.6%) primary outcome events were recorded: 175 (8.7%) in patients with AS and 38 (8.0%) in those with PS. In patients who initiated OAT within 2 days, the primary outcome occurred in 5 out of 95 patients (5.3%) with PS compared to 21 out of 373 patients (4.3%) with AS (OR 1.07; 95% CI 0.39-2.94). In patients who initiated OAT between days 3 and 7, the primary outcome occurred in 3 out of 103 patients (2.9%) with PS compared to 26 out of 490 patients (5.3%) with AS (OR 0.54; 95% CI 0.16-1.80).

Discussion: our findings suggest that, when deciding the time to initiate oral anticoagulation, the location of stroke, either anterior or posterior, does not predict the risk of outcome events.

Conclusions: Patients with PS or AS and AF appear to have similar risks of ischaemic or haemorrhagic events at 90 days with no difference concerning the timing of initiation of OAT.
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http://dx.doi.org/10.1177/2396987320937116DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7856592PMC
December 2020

The paradigm shift in long-term treatments for migraine prevention.

Eur J Neurol 2021 Feb 12. Epub 2021 Feb 12.

Neuroscience Section, Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila, L'Aquila, Italy.

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http://dx.doi.org/10.1111/ene.14768DOI Listing
February 2021

Thrombophilic alterations, migraine, and vascular disease: results from a case-control study.

Neurol Sci 2021 Jan 20. Epub 2021 Jan 20.

Institute of Neurology, Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila, L'Aquila, Italy.

Background: The association between thrombophilic alterations, migraine, and vascular events has been broadly investigated but not been completely clarified.

Methods: In this cross-sectional, case-control study, we included consecutive outpatients diagnosed with migraine referring to a tertiary headache center. Migraine patients were matched to headache-free control subjects. All participants were evaluated for free protein S anticoagulant, functional protein C anticoagulant, homocysteine, and antiphospholipid antibodies (aPLs). History of ischemic stroke (IS) or transient ischemic attack (TIA), coronary heart disease, and peripheral venous thrombosis was also ascertained.

Results: We included 329 migraine patients and 329 control subjects (mean age 41 years, 77% women in both groups). Among migraine patients, 239 (72.6%) had migraine without aura and 90 (27.4%) had migraine with aura. Migraine patients had more frequently arterial hypertension, hypercholesterolemia, history of IS or TIA and, peripheral venous thrombosis compared to control subjects, whereas we found no differences in diabetes mellitus, BMI, and coronary heart disease between the two groups. At least one thrombophilic alteration was detected in 107 (32.5%) migraine patients and in 74 (22.5%) control subjects (OR = 1.66, 95% CI 1.17-2.35, p = 0.004). We identified an association of migraine with aPL positivity (OR = 2.6, 95% CI 1.5-4.7, p = 0.001) and with free protein S deficiency (OR = 4.7, 95% CI 1.6-14.0, p = 0.002), whereas we found no differences in protein C deficiency, APCR, and hyperhomocysteinemia between the two groups. Furthermore, aPL positivity and free protein S deficiency were more common in migraine patients with and without aura than in control subjects. We found that in migraine patients, aPL positivity was associated with both IS or TIA (OR = 5.6, 95% CI 1.5-20.4, p = 0.009) and with coronary heart disease (OR = 27.6, 95% CI 1.4-531.1, p = 0.028), whereas free protein S deficiency was associated with IS or TIA only (OR = 14.3, 95% CI 2.8-74.4, p = 0.002).

Conclusions: Our research documented a significative higher prevalence of aPL positivity and protein S deficiency in migraineurs than in controls. Data also showed an association between these alterations and some vascular thrombotic events in migraine patients. We can argue that thrombophilic disorders associated with migraine may contribute to the occurrence of vascular events.
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http://dx.doi.org/10.1007/s10072-020-05006-zDOI Listing
January 2021

Comment on 'Clopidogrel can be an effective complementary prophylactic for drug-refractory migraine with patent foramen ovale'.

J Investig Med 2021 Feb 18;69(2):411-412. Epub 2020 Dec 18.

Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila, L'Aquila, Italy.

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http://dx.doi.org/10.1136/jim-2020-001687DOI Listing
February 2021

Association between response to triptans and response to erenumab: real-life data.

J Headache Pain 2021 Jan 6;22(1). Epub 2021 Jan 6.

Neuroscience Section, Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila, Via Vetoio 1, 67100, L'Aquila, Italy.

Background: Triptans and erenumab are both migraine-specific agents acting on the calcitonin gene-related peptide pathway. Therefore, response to triptans might be associated with response to erenumab.

Main Body: In our study, consecutive patients referring to the Headache Centers of the Abruzzo region from January 2019 to March 2020 and treated with erenumab were interviewed about past use and efficacy of triptans. Triptan users were classified as 'triptan responders' if they were headache-free 2 h after treating ≥3 migraine attacks with ≥1 triptan. We considered patients as 'erenumab responders', if they had a ≥ 50% mean reduction in monthly migraine days between the 4th and the 6th month from treatment start compared with baseline. Of 91 triptan users, 73 (80.2%) were triptan responders and 58 (63.7%) were erenumab responders. The odds ratio of being erenumab responder was 3.64 (95% CI, 1.25-10.64) for triptan users as compared to non-users. (P = 0.014). Besides, starting erenumab improved triptan response in both erenumab responders and non-responders.

Conclusions: Our data of an association between response to triptans and response to erenumab can be useful for patient advice and to improve the understanding of migraine pathophysiology and treatment.
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http://dx.doi.org/10.1186/s10194-020-01213-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7789681PMC
January 2021

Multimodal MRI Assessment of Thalamic Structural Changes in Earthquake Survivors.

Diagnostics (Basel) 2021 Jan 4;11(1). Epub 2021 Jan 4.

Department of Biotechnology and Applied Clinical Sciences, University of L'Aquila, 67100 L'Aquila, Italy.

Moving from the central role of the thalamus in the integration of inner and external stimuli and in the implementation of a stress-related response, the objective of the present study was to investigate the presence of any MRI structural and volumetric changes of the thalamic structures in earthquake witnesses. Forty-one subjects were included, namely 18 university students belonging to the experimental earthquake-exposed group (8 males and 10 females, mean age 24.5 ± 1.8 years) and a control group of 23 students not living in any earthquake-affected areas at the time of the earthquake (14 males and 9 females, mean age 23.7 ± 2.0 years). Instrumental MRI evaluation was performed using a 3-Tesla scanner, by acquiring a three-dimensional fast spoiled gradient-echo (FSPGR) sequence for volumetric analysis and an EPI (echoplanar imaging) sequence to extract fractional anisotropy (FA) and apparent diffusion coefficient (ADC) values. As compared to the control one, the experimental group showed significantly lower gray matter volume in the mediodorsal nucleus of the left thalamus ( < 0.001). The dominant hemisphere thalamus in the experimental group showed higher mean ADC values and lower mean FA values as compared to the control group.
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http://dx.doi.org/10.3390/diagnostics11010070DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7824088PMC
January 2021

Early outcomes of migraine after erenumab discontinuation: data from a real-life setting.

Neurol Sci 2021 Jan 2. Epub 2021 Jan 2.

Neuroscience Section, Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila, Via Vetoio, 67100, L'Aquila, Italy.

Background: Monoclonal antibodies targeting the calcitonin gene-related peptide, including erenumab, are migraine-specific preventive treatments, whose long-term effectiveness has still to be evaluated in real-life settings. We assessed early outcomes of erenumab discontinuation after a 52-week treatment in patients with a continuous positive response to the drug.

Methods: We evaluated the early outcomes after treatment completion in migraineurs from a real-life multicenter register. All patients received monthly erenumab for 52 weeks and attended a 8-week follow-up after treatment completion. Primary outcomes were responder rates and changes in monthly migraine days (MMDs), acute medications days (AMDs), and pain intensity on a Numerical Rating Scale (NRS score) during weeks 1-4 after erenumab treatment completion.

Results: The 32 included patients reported a decrease in MMDs, AMDs, and NRS score during the last 4 weeks of treatment compared with baseline (P<0.001). During weeks 1-4 after treatment completion, all the outcome measures increased compared with the last 4 weeks of treatment (P < 0.001) despite staying lower than baseline (MMDs and AMDs P < 0.001, NRS score P = 0.005). Over the same time frame, 18 (56%) patients maintained a ≥ 50% reduction from baseline in MMDs. At week 4 after treatment completion, 10 (31%) patients restarted treatment due to disease rebound to baseline levels.

Conclusions: More than half patients had an early disease worsening, while the remaining patients maintained their responder status during weeks 1-4 after treatment completion. Further studies might identify predictors of prolonged response to erenumab and define the optimal treatment duration according to patients' characteristics.
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http://dx.doi.org/10.1007/s10072-020-05022-zDOI Listing
January 2021

Mechanical Thrombectomy for Acute Intracranial Carotid Occlusion with Patent Intracranial Arteries : The Italian Registry of Endovascular Treatment in Acute Stroke.

Clin Neuroradiol 2020 Dec 10. Epub 2020 Dec 10.

Stroke Unit, University of Rome La Sapienza, Roma, Italy.

Purpose: Intracranial carotid artery occlusion represents an underinvestigated cause of acute ischemic stroke as well as an indication for mechanical thrombectomy. We investigated baseline and procedural characteristics, outcomes and predictors of outcome in patients with acute ischemic stroke secondary to intracranial carotid artery occlusion.

Methods: A retrospective analysis of the Italian Registry of Endovascular Treatment in Acute Stroke was performed. Patients with intracranial carotid artery occlusion (infraclinoid and supraclinoid) with or without cervical artery occlusion but with patent intracranial arteries were included. The 3‑month functional independence, mortality, successful reperfusion and symptomatic intracranial hemorrhage were evaluated.

Results: Intracranial carotid artery occlusion with patent intracranial arteries was diagnosed in 387 out of 4940 (7.8%) patients. The median age was 74 years and median baseline National Institute of Health Stroke Scale (NIHSS) was 18. Functional independence was achieved in 130 (34%) patients, successful reperfusion in 289 (75%) and symptomatic intracranial hemorrhage in 33 (9%), whereas mortality occurred in 111 (29%) patients. In univariate analysis functional independence was associated with lower age, lower NIHSS at presentation, higher rate of successful reperfusion and lower rate of symptomatic intracranial hemorrhage. Multivariable regression analysis found age (odds ratio, OR:1.03; P = 0.006), NIHSS at presentation (OR: 1.07; P < 0.001), diabetes (OR: 2.60; P = 0.002), successful reperfusion (OR:0.20; P < 0.001) and symptomatic intracranial hemorrhage (OR: 4.17; P < 0.001) as the best independent predictors of outcome.

Conclusion: Our study showed a not negligible rate of intracranial carotid artery occlusion with patent intracranial arteries, presenting mostly as severe stroke, with an acceptable rate of 3‑month functional independence. Age, NIHSS at presentation and successful reperfusion were the best independent predictors of outcome.
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http://dx.doi.org/10.1007/s00062-020-00980-5DOI Listing
December 2020

Complications of mechanical thrombectomy for acute ischemic stroke: Incidence, risk factors, and clinical relevance in the Italian Registry of Endovascular Treatment in acute stroke.

Int J Stroke 2020 Dec 6:1747493020976681. Epub 2020 Dec 6.

Interventional Neurovascular Unit and Stroke Unit, Ospedale Careggi-University Hospital, Firenze, Italy.

Background: There are limited data concerning procedure-related complications of endovascular thrombectomy for large vessel occlusion strokes.

Aims: We evaluated the cumulative incidence, the clinical relevance in terms of increased disability and mortality, and risk factors for complications.

Methods: From January 2011 to December 2017, 4799 patients were enrolled by 36 centers in the Italian Registry of Endovascular Stroke Treatment. Data on demographic and procedural characteristics, complications, and clinical outcome at three months were prospectively collected.

Results: The complications cumulative incidence was 201 per 1000 patients undergoing endovascular thrombectomy. Ongoing antiplatelet therapy (p < 0.01; OR 1.82, 95% CI: 1.21-2.73) and large vessel occlusion site (carotid-T, p < 0.03; OR 3.05, 95% CI: 1.13-8.19; M2-segment-MCA, p < 0.01; OR 4.54, 95% CI: 1.66-12.44) were associated with a higher risk of subarachnoid hemorrhage/arterial perforation. Thrombectomy alone (p < 0.01; OR 0.50, 95% CI: 0.31-0.83) and younger age (p < 0.04; OR 0.98, 95% CI: 0.97-0.99) revealed a lower risk of developing dissection. M2-segment-MCA occlusion (p < 0.01; OR 0.35, 95% CI: 0.19-0.64) and hypertension (p < 0.04; OR 0.77, 95% CI: 0.6-0.98) were less related to clot embolization. Higher NIHSS at onset (p < 0.01; OR 1.04, 95% CI: 1.02-1.06), longer groin-to-reperfusion time (p < 0.01; OR 1.05, 95% CI: 1.02-1.07), diabetes (p < 0.01; OR 1.67, 95% CI: 1.25-2.23), and LVO site (carotid-T, p < 0.01; OR 1.96, 95% CI: 1.26-3.05; M2-segment-MCA, p < 0.02; OR 1.62, 95% CI: 1.08-2.42) were associated with a higher risk of developing symptomatic intracerebral hemorrhage compared to no/asymptomatic intracerebral hemorrhage. The subgroup of patients treated with thrombectomy alone presented a lower risk of symptomatic intracerebral hemorrhage (p < 0.01; OR 0.70; 95% CI: 0.55-0.90). Subarachnoid hemorrhage/arterial perforation and symptomatic intracerebral hemorrhage after endovascular thrombectomy worsen both functional independence and mortality at three-month follow-up (p < 0.01). Distal embolization is associated with neurological deterioration (p < 0.01), while arterial dissection did not affect clinical outcome at follow-up.

Conclusions: Complications globally considered are not uncommon and may result in poor clinical outcome. Early recognition of risk factors might help to prevent complications and manage them appropriately in order to maximize endovascular thrombectomy benefits.
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http://dx.doi.org/10.1177/1747493020976681DOI Listing
December 2020

Investigating the Effects of COVID-19 Quarantine in Migraine: An Observational Cross-Sectional Study From the Italian National Headache Registry (RICe).

Front Neurol 2020 10;11:597881. Epub 2020 Nov 10.

Applied Neurophysiology and Pain Unit, Scienze Mediche di Base, Neuroscienze e Organi di Senso Department, Bari Aldo Moro University, Bari, Italy.

Previous studies during SARS and Ebola pandemics have shown that quarantine is associated with several negative psychological effects, such as post-traumatic stress symptoms, confusion, and anger. These conditions may affect the course of many diseases, including migraine. Although it is possible that the quarantine measures for the current COVID-19 pandemic affect migraine burden, no information is currently available on this issue. In this study, we aimed to: (1) explore the possible changes in migraine frequency, severity, and days with acute medication intake during quarantine period; (2) evaluate possible differences in migraine outcomes in consideration of lifestyle changes, emotions, pandemic diffusion, and COVID-19 infection. We interviewed patients who were included in the observational Italian Headache Registry (Registro Italiano Cefalee, RICE), retrospectively collecting information on main headache features, lifestyle factors, emotions, individual infection status, and perception of COVID-19 for 2 months before (pre-quarantine) and after the beginning of the quarantine (quarantine). Inclusion criteria were: age > 18, diagnosis of migraine without aura, migraine with aura and chronic migraine, last in-person visit more than 3 months preceding the beginning of quarantine. A total of 433 migraine subjects agreed to be interviewed. We found an overall reduction in headache frequency (9.42 ± 0.43 days with headache vs. 8.28 ± 0.41) and intensity (6.57 ± 0.19 vs. 6.59 ± 0.21) during the quarantine, compared to pre-quarantine. There was a correlation between improvement and number of days of stay-at-home. When results were stratified for geographic area, we found a tendency toward worsening of headache frequency in northern Italy. Disgust regarding viral infection corresponded to a minor improvement in migraine. Migraine patients showed a mild improvement of migraine features, probably attributable to resilient behavior toward pandemic distress. Disgust regarding the contagion whereas potentially favoring defensive behavior, could potentially worsen migraine. The spontaneous limitation of migraine burden during quarantine could favor patient follow-up via the use of telemedicine visits, reliable diaries, and frequent remote contacts.
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http://dx.doi.org/10.3389/fneur.2020.597881DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7683429PMC
November 2020

Migraine and sleep disorders: a systematic review.

J Headache Pain 2020 Oct 27;21(1):126. Epub 2020 Oct 27.

Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila, L'Aquila, Italy.

Migraine and sleep disorders are common and often burdensome chronic conditions with a high prevalence in the general population, and with considerable socio-economic impact and costs.The existence of a relationship between migraine and sleep disorders has been recognized from centuries by clinicians and epidemiological studies. Nevertheless, the exact nature of this association, the underlying mechanisms and interactions are complex and not completely understood. Recent biochemical and functional imaging studies identified central nervous system structures and neurotransmitters involved in the pathophysiology of migraine and also important for the regulation of normal sleep architecture, suggesting a possible causative role, in the pathogenesis of both disorders, of a dysregulation in these common nervous system pathways.This systematic review summarizes the existing data on migraine and sleep disorders with the aim to evaluate the existence of a causal relationship and to assess the presence of influencing factors. The identification of specific sleep disorders associated with migraine should induce clinicians to systematically assess their presence in migraine patients and to adopt combined treatment strategies.
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http://dx.doi.org/10.1186/s10194-020-01192-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7590682PMC
October 2020

Reduced Admissions for Cerebrovascular Events During COVID-19 Outbreak in Italy.

Stroke 2020 12 16;51(12):3746-3750. Epub 2020 Oct 16.

Department of Human Neurosciences, Sapienza University of Rome, Italy (L.P., D.T.).

Background And Purpose: We aimed to investigate the rate of hospital admissions for cerebrovascular events and of revascularization treatments for acute ischemic stroke in Italy during the coronavirus disease 2019 (COVID-19) outbreak.

Methods: The Italian Stroke Organization performed a multicenter study involving 93 Italian Stroke Units. We collected information on hospital admissions for cerebrovascular events from March 1 to March 31, 2020 (study period), and from March 1 to March 31, 2019 (control period).

Results: Ischemic strokes decreased from 2399 in 2019 to 1810 in 2020, with a corresponding hospitalization rate ratio (RR) of 0.75 ([95% CI, 0.71-0.80] <0.001); intracerebral hemorrhages decreased from 400 to 322 (hospitalization RR, 0.81 [95% CI, 0.69-0.93]; =0.004), and transient ischemic attacks decreased from 322 to 196 (hospitalization RR, 0.61 [95% CI, 0.51-0.73]; <0.001). Hospitalizations decreased in Northern, Central, and Southern Italy. Intravenous thrombolyses decreased from 531 (22.1%) in 2019 to 345 in 2020 (19.1%; RR, 0.86 [95% CI, 0.75-0.99]; =0.032), while primary endovascular procedures increased in Northern Italy (RR, 1.61 [95% CI, 1.13-2.32]; =0.008). We found no correlation (=0.517) between the hospitalization RRs for all strokes or transient ischemic attack and COVID-19 incidence in the different areas.

Conclusions: Hospitalizations for stroke or transient ischemic attacks across Italy were reduced during the worst period of the COVID-19 outbreak. Intravenous thrombolytic treatments also decreased, while endovascular treatments remained unchanged and even increased in the area of maximum expression of the outbreak. Limited hospitalization of the less severe patients and delays in hospital admission, due to overcharge of the emergency system by COVID-19 patients, may explain these data.
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http://dx.doi.org/10.1161/STROKEAHA.120.031293DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7678662PMC
December 2020

What is changing in chronic migraine treatment? An algorithm for onabotulinumtoxinA treatment by the Italian chronic migraine group.

Expert Rev Neurother 2020 12 30;20(12):1275-1286. Epub 2020 Sep 30.

Department of Clinical and Molecular Medicine, Faculty of Medicine and Psychology, Sant'Andrea Hospital, Sapienza University , Rome, Italy.

Introduction: OnabotulinumtoxinA (OBT-A) and monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway are two of the few treatments that ameliorate chronic migraine (CM) in randomized controlled trials and real-life studies. Separate clinical practice guidelines have been developed for the management of CM with OBT-A or CGRP-targeting mAbs.

Areas Covered: Considering the concomitant availability of OBT-A and CGRP-targeting mAbs as therapeutic treatment options, Italian migraine experts reviewed the evidence supporting the efficacy of OBT-A and CGRP-targeting mAbs in CM in order to rationalize the management of CM patients treated with OBT-A. Experts addressed everyday practice needs to shape the optimal pharmacological management by balancing adherence to regulatory indications, ethical considerations, and clinical expertise. Considering the remarkable challenge of improving the health and quality of life of patients with CM, even partial improvements may be clinically meaningful, particularly for those who are resistant or intolerant to oral migraine treatments.

Expert Opinion: In this collaborative effort, we propose a treatment algorithm that integrates the relevant aspects of managing patients with CM to provide ready-to-use practical guidance regarding the appropriate use of OBT-A.
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http://dx.doi.org/10.1080/14737175.2020.1825077DOI Listing
December 2020

Migraine and rare neurological disorders.

Neurol Sci 2020 Dec;41(Suppl 2):439-446

Cerebrovascular Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Celoria 11, 20133, Milan, Italy.

Although migraine is generally considered an idiopathic and isolated neurological condition, it may also represent the presenting symptom of several uncommon heritable and acquired neurological diseases contributing to the recognition of such conditions. Migraine may indeed present with atypical characteristics or prolonged duration and may be associated with specific neuroradiological findings that may help in identifying the underlying condition. However, features of migraine in rare diseases are usually little known because of the lack of systematic studies. The aim of this paper is to provide clinicians with an updated review on specific clinical and neuroradiological features of migraine in uncommon neurological diseases that may be helpful to their diagnosis and treatment. Therefore, the early diagnosis of these uncommon diseases is crucial for patients' clinical management and for the implementation of therapeutic approaches aimed at targeting the underlying disease pathogenic mechanisms. Thus, when investigating patients affected by migraine, physicians should always be aware about rare causes of migraine that if misdiagnosed could seriously impact patients' outcome. Given these relevant implications, future studies specifically assessing features of migraine in uncommon diseases are mandatory.
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http://dx.doi.org/10.1007/s10072-020-04645-6DOI Listing
December 2020

Increased cardiovascular death rates in a COVID-19 low prevalence area.

J Clin Hypertens (Greenwich) 2020 10 20;22(10):1932-1935. Epub 2020 Aug 20.

Department of Life, Health, and Environmental Sciences, San Salvatore Hospital, University of L'Aquila, L'Aquila, Italy.

The province of L'Aquila (Central Italy) was marginally affected by COVID-19 pandemic, but changes in health care seeking behaviors were noticed. The authors retrospectively analyzed de-identified data concerning all-cause and cardiovascular hospitalizations, cardiovascular acute phase treatments, and in-hospital cardiovascular deaths in the province of L'Aquila from January 1 to March 31, in 2020 and 2019. Incidence rate ratios (IRR) comparing 2020 and 2019 for admissions/procedures were calculated through Poisson regression. All-cause and cardiovascular mortality in the examined time windows was also assessed. Less all-cause (IRR 0.85, P < .001) and cardiovascular (IRR 0.73, P < .001) hospitalizations occurred in 2020 than in 2019. Less daily cardiovascular procedures were also performed (IRR: 0.74, P = .009). A disproportionate decrease in the number of procedures was observed in relation to cardiovascular hospitalizations in 2020 (-5.5%, P = .001). Unlike all-cause mortality, more in-hospital cardiovascular deaths occurred in March 2020 compared with March 2019 (+6.8%, P = .048).
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http://dx.doi.org/10.1111/jch.14013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7461222PMC
October 2020

Conversion from chronic to episodic migraine in patients treated with erenumab: real-life data from an Italian region.

J Headache Pain 2020 Aug 15;21(1):102. Epub 2020 Aug 15.

Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila, Via Vetoio 1, 67100, L'Aquila, Italy.

Background: Most patients treated with erenumab in clinical practice have chronic migraine (CM). We assessed the rate and possible predictors of conversion from CM to episodic migraine (EM) in a real-life study.

Main Body: We performed a subgroup analysis of patients treated with erenumab from January 2019 to February 2020 in the Abruzzo region, central Italy. Treatment was provided according to current clinical practice. For the purpose of the present study, we included patients fulfilling the definition of CM for the three months preceding erenumab treatment and with at least 6 months of follow-up after treatment. We assessed the rate of conversion to EM from baseline to Months 4-6 of treatment and during each month of treatment. To test the clinical validity of conversion to EM, we also assessed the decrease in monthly headache days (MHDs), acute medication days, and median headache intensity on a Numerical Rating Scale (NRS). We included in our study 91 patients with CM. At Months 4-6, 62 patients (68.1%) converted from CM to EM; the proportion of converters increased from Month 1 to Month 5. In the overall group of patients, median MHDs decreased from 26.5 (IQR 20-30) to 7.5 (IQR 5-16; P < 0.001) compared with baseline, while median acute medication days decreased from 21 (IQR 16-30) to 6 (IQR 3-10; P < 0.001) and median NRS scores decreased from 8 (IQR 7-9) to 6 (IQR 4-7; P < 0.001). Significant decreases were found both in converters and in non-converters. We found no significant predictors of conversion to EM among the patients' baseline characteristics.

Conclusions: In our study, two thirds of patients with CM converted to EM during 6 months of treatment with erenumab. MHDs, acute medication use, and headache intensity decreased regardless of conversion from CM to EM.
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http://dx.doi.org/10.1186/s10194-020-01171-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7429460PMC
August 2020

Wear-Off of OnabotulinumtoxinA Effect Over the Treatment Interval in Chronic Migraine: A Retrospective Chart Review With Analysis of Headache Diaries.

Headache 2020 Sep 14;60(8):1673-1682. Epub 2020 Aug 14.

Department of Neurology, Austin Health, Heidelberg, Australia.

Objective: To quantify wear-off of the response to OnabotulinumtoxinA (OnabotA) treatment over the treatment cycle in chronic migraine at group and individual level.

Background: OnabotA administered quarterly is an effective treatment for chronic migraine. However, some patients report that headache recurs before the scheduled follow-up injection.

Methods: In this retrospective chart review performed in 6 university outpatient centers or private practices specialized in headache treatment, 112 patients with a ≥30% response to OnabotA who completed headache diaries over 13 weeks after OnabotA treatment were included (age [mean ± SD] 45 ± 12 years, 82% female, headache days/month at baseline 24 ± 6).

Results: Compared to weeks 5 to 8 after injection, headache days/week increased significantly in weeks 12 (+0.52 ± 1.96, 95% CI [0.15, 0.88], P < .009) and 13 (+1.15 ± 1.95, CI[0.79, 1.52], P < .001), demonstrating significant wear-off of the OnabotA effect. Similarly, acute medication days/week significantly increased in weeks 12 (0.38±1.67, CI [0.06, 0.69], P ≤ .027) and 13 (+0.83 ± 1.76, CI [0.49, 1.16], P < .001). At an individual level, 57 patients (51%) showed ≥30% wear-off by weeks 12 and 13, and 28 patients (25%) showed ≥30% wear-off already by weeks 10 and 11. Age, gender, OnabotA dose or cycle number, or headache center did not predict individual wear-off.

Conclusions: These data show that in clinical practice, on average the response of chronic migraine patients to OnabotA injection shows a clinically significant wear-off from week 12 after treatment. About 25% of the patients experience wear-off even by weeks 10 and 11. It must be noted that wear-off detected in a real-world study on OnabotA responders can be due to wear-off of a pharmacological OnabotA effect or a placebo effect, or to regression to the mean effects. This wear-off phenomenon may negatively affect quality of life of chronic migraine patients under OnabotA treatment. The best way to counteract wear-off remains to be determined.
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http://dx.doi.org/10.1111/head.13925DOI Listing
September 2020

Efficacy and safety of greater occipital nerve block for the treatment of cluster headache: a systematic review and meta-analysis.

Expert Rev Neurother 2020 11 31;20(11):1157-1167. Epub 2020 Aug 31.

Neuroscience Section, Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila , L'Aquila, Italy.

Introduction: The treatment of cluster headache (CH) is challenging in view of the few evidence-based treatments. The authors aim to summarize the evidence of efficacy and safety of greater occipital nerve blocks (GONBs) in CH.

Areas Covered: The authors included papers indexed in PubMed and Web of Science from the beginning of indexing to 5 May 2020. They included both observational and randomized studies referring to patients with episodic and/or chronic CH. The authors identified 12 studies on 365 patients. Five studies (two randomized controlled trials) could be included in the meta-analyses. The pooled proportion of pain-free subjects at 1 month was 50% (95% CI 24-76%) with considerable heterogeneity (I = 88%; P < 0.01). The pooled relative risk ratio of pain freedom at 1 month in active versus control groups in the two included randomized controlled trials was 4.86 (95% CI, 1.35-17.55) without statistical heterogeneity (I = 0%; P = 0.39). Three studies showed decreased attack intensity, frequency, and duration after GONBs. The studies reported mild and transient adverse events.

Expert Opinion: Despite several limitations and considerable heterogeneity, the available data support the efficacy and safety of GONBs for the treatment of CH. Further large randomized trials are needed to confirm efficacy and establish optimal treatment protocols.
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http://dx.doi.org/10.1080/14737175.2020.1809379DOI Listing
November 2020

Direct thrombectomy for stroke in the presence of absolute exclusion criteria for thrombolysis.

J Neurol 2020 Dec 25;267(12):3731-3740. Epub 2020 Jul 25.

Sapienza University Hospital, Rome, Italy.

Background: Intravenous thrombolysis (IVT)-ineligible patients undergoing direct thrombectomy tended to have poorer functional outcome as compared with IVT-eligible patients undergoing bridging therapy. We aimed to assess radiological and functional outcomes in large vessel occlusion-related stroke patients receiving direct thrombectomy in the presence of absolute exclusion criteria for IVT vs relative exclusion criteria for IVT and vs non-exclusion criteria for IVT.

Methods: A cohort study on prospectively collected data from 2282 patients enrolled in the Italian Registry of Endovascular Treatment in Acute Stroke cohort for treatment with direct thrombectomy (n = 486, absolute exclusion criteria for IVT alone; n = 384, absolute in combination with relative exclusion criteria for IVT; n = 777, relative exclusion criteria for IVT alone; n = 635, non-exclusion criteria for IVT).

Results: After adjustment for unbalanced variables (model 1), ORs for 3-month death was higher in the presence of absolute exclusion criteria for IVT alone (vs relative exclusion criteria for IVT alone) (1.595, 95% CI 1.042-2.440) and in the presence of absolute exclusion criteria for IVT alone (vs non-exclusion criteria for IVT) (1.235, 95% CI 1.014-1.504). After adjustment for predefined variables (model 2: age, sex, pre-stroke mRS ≤ 1, NIHSS, occlusion in the anterior circulation, onset-to-groin time, and procedure time), ORs for 3-month death was higher in the presence of absolute exclusion criteria for IVT alone (vs relative exclusion criteria for IVT alone) (1.235, 95% CI 1.014-1.504) and in the presence of absolute exclusion criteria for IVT alone (vs non-exclusion criteria for IVT) (1.246, 95% CI 1.039-1.495). No significant difference was found between the groups as regards any type of intracerebral hemorrhage and parenchymal hematoma within 24 h, successful and complete recanalization after procedure, and modified Rankin Scale score 0-2 at 3 months. After adjustment for predefined variables of model 2, ORs for death were higher in the presence of recent administration of IV heparin (OR: 2.077), platelet count < 100,000/mm (OR: 4.798), bacterial endocarditis (OR: 15.069), neoplasm with increased hemorrhagic risk (OR: 6.046), and severe liver disease (OR: 6.124).

Conclusions: Radiological outcomes were similar after direct thrombectomy in patients with absolute, relative, and non- exclusion criteria for IVT, while an increase of fatal outcome was observed in the presence of some absolute exclusion criterion for IVT.
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http://dx.doi.org/10.1007/s00415-020-10098-wDOI Listing
December 2020

Safety of Anticoagulation in Patients Treated With Urgent Reperfusion for Ischemic Stroke Related to Atrial Fibrillation.

Authors:
Michela Giustozzi Monica Acciarresi Giancarlo Agnelli Valeria Caso Fabio Bandini Georgios Tsivgoulis Shadi Yaghi Karen L Furie Prasanna Tadi Cecilia Becattini Marialuisa Zedde Azmil H Abdul-Rahim Kennedy R Lees Andrea Alberti Michele Venti Cataldo D'Amore Maria Giulia Mosconi Ludovica Anna Cimini Paolo Bovi Monica Carletti Alberto Rigatelli Manuel Cappellari Jukka Putaala Liisa Tomppo Turgut Tatlisumak Simona Marcheselli Alessandro Pezzini Loris Poli Alessandro Padovani Vieri Vannucchi Sung-Il Sohn Gianni Lorenzini Rossana Tassi Francesca Guideri Maurizio Acampa Giuseppe Martini George Ntaios George Athanasakis Konstantinos Makaritsis Efstathia Karagkiozi Konstantinos Vadikolias Chrissoula Liantinioti Aikaterini Theodorou Panagiotis Halvatsiotis Nicola Mumoli Franco Galati Simona Sacco Cindy Tiseo Francesco Corea Walter Ageno Marta Bellesini Giorgio Silvestrelli Alfonso Ciccone Alessia Lanari Umberto Scoditti Licia Denti Michelangelo Mancuso Elena Ferrari Leonardo Ulivi Giovanni Orlandi Nicola Giannini Tiziana Tassinari Maria Luisa De Lodovici Christina Rueckert Antonio Baldi Danilo Toni Federica Letteri Martina Giuntini Enrico Maria Lotti Yuriy Flomin Alessio Pieroni Odysseas Kargiotis Theodore Karapanayiotides Serena Monaco Mario Maimone Baronello Laszló Csiba Lilla Szabó Alberto Chiti Elisa Giorli Massimo Del Sette Davide Imberti Dorjan Zabzuni Boris Doronin Vera Volodina Patrik Michel Peter Vanacker Kristian Barlinn Jessica Barlinn Dirk Deleu Vanessa Gourbali Maurizio Paciaroni Luca Masotti

Stroke 2020 08 10;51(8):2347-2354. Epub 2020 Jul 10.

Internal Medicine, Santa Maria Nuova Hospital, Firenze, Italy (V. Vannucchi, L.M.).

Background And Purpose: The optimal timing for starting oral anticoagulant after an ischemic stroke related to atrial fibrillation remains a challenge, mainly in patients treated with systemic thrombolysis or mechanical thrombectomy. We aimed at assessing the incidence of early recurrence and major bleeding in patients with acute ischemic stroke and atrial fibrillation treated with thrombolytic therapy and/or thrombectomy, who then received oral anticoagulants for secondary prevention.

Methods: We combined the dataset of the RAF and the RAF-NOACs (Early Recurrence and Major Bleeding in Patients With Acute Ischemic Stroke and Atrial Fibrillation Treated With Non-Vitamin K Oral Anticoagulants) studies, which were prospective observational studies carried out from January 2012 to March 2014 and April 2014 to June 2016, respectively. We included consecutive patients with acute ischemic stroke and atrial fibrillation treated with either vitamin K antagonists or nonvitamin K oral anticoagulants. Primary outcome was the composite of stroke, transient ischemic attack, symptomatic systemic embolism, symptomatic cerebral bleeding, and major extracerebral bleeding within 90 days from the inclusion. Treated-patients were propensity matched to untreated-patients in a 1:1 ratio after stratification by baseline clinical features.

Results: A total of 2159 patients were included, 564 (26%) patients received acute reperfusion therapies. After the index event, 505 (90%) patients treated with acute reperfusion therapies and 1287 of 1595 (81%) patients untreated started oral anticoagulation. Timing of starting oral anticoagulant was similar in reperfusion-treated and untreated patients (median 7.5 versus 7.0 days, respectively). At 90 days, the primary study outcome occurred in 37 (7%) patients treated with reperfusion and in 146 (9%) untreated patients (odds ratio, 0.74 [95% CI, 0.50-1.07]). After propensity score matching, risk of primary outcome was comparable between the 2 groups (odds ratio, 1.06 [95% CI, 0.53-2.02]).

Conclusions: Acute reperfusion treatment did not influence the risk of early recurrence and major bleeding in patients with atrial fibrillation-related acute ischemic stroke, who started on oral anticoagulant.
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http://dx.doi.org/10.1161/STROKEAHA.120.030143DOI Listing
August 2020

SiPP (Stroke in Pregnancy and Postpartum): A prospective, observational, international, multicentre study on pathophysiological mechanisms, clinical profile, management and outcome of cerebrovascular diseases in pregnant and postpartum women.

Eur Stroke J 2020 Jun 6;5(2):193-203. Epub 2019 Dec 6.

Department of Clinical Sciences and Biotechnology, University of L'Aquila, L'Aquila, Italy.

Rationale: Cerebrovascular diseases associated with pregnancy and postpartum period are uncommon; however, they can have an important impact on health of both women and foetus or newborn.

Aims: To evaluate the frequency, characteristics and management of cerebrovascular events in pregnant/postpartum women, to clarify pathophysiological mechanisms underlying the occurrence of these events including biomolecular aspects, and to assess the short- and long-term cerebrovascular and global cardiovascular outcome of these patients, their predictors and infant outcome.

Methods And Design: This is an observational, prospective, multicentre, international case-control study. The study will include patients with cerebrovascular events during pregnancy and/or within six months after delivery. For each included case, two controls will be prospectively recruited: one pregnant or puerperal subject without any history of cerebrovascular event and one non-pregnant or non-puerperal subject with a recent cerebrovascular event. All controls will be matched by age, ethnicity and type of cerebrovascular event with their assigned cases. The pregnant controls will be matched also by pregnancy weeks/trimester. Follow-up will last 24 months for the mother and 12 months for the infant.

Summary: To better understand causes and outcomes of uncommon conditions like pregnancy/postpartum-related cerebrovascular events, the development of multisite, multidisciplinary registry-based studies, such as the Stroke in Pregnancy and Postpartum study, is needed in order to collect an adequate number of patients, draw reliable conclusions and give definite recommendations on their management.
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http://dx.doi.org/10.1177/2396987319893512DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7313370PMC
June 2020

Endovascular Thrombectomy for Acute Ischemic Stroke Beyond 6 Hours From Onset: A Real-World Experience.

Stroke 2020 07 17;51(7):2051-2057. Epub 2020 Jun 17.

Emergency Department Stroke Unit, Sapienza University Hospital, Rome (E.N., D.T.).

Background And Purpose: To evaluate outcome and safety of endovascular treatment beyond 6 hours of onset of ischemic stroke due to large vessel occlusion in the anterior circulation, in routine clinical practice.

Methods: From the Italian Registry of Endovascular Thrombectomy, we extracted clinical and outcome data of patients treated for stroke of known onset beyond 6 hours. Additional inclusion criteria were prestroke modified Rankin Scale score ≤2 and ASPECTS score ≥6. Patients were selected on individual basis by a combination of CT perfusion mismatch (difference between total hypoperfusion and infarct core sizes) and CT collateral score. The primary outcome measure was the score on modified Rankin Scale at 90 days. Safety outcomes were 90-day mortality and the occurrence of symptomatic intracranial hemorrhage. Data were compared with those from patients treated within 6 hours.

Results: Out of 3057 patients, 327 were treated beyond 6 hours. Their mean age was 66.8±14.9 years, the median baseline National Institutes of Health Stroke Scale 16, and the median onset to groin puncture time 430 minutes. The most frequent site of occlusion was middle cerebral artery (45.1%). Functional independence (90-day modified Rankin Scale score, 0-2) was achieved by 41.3% of cases. Symptomatic intracranial hemorrhage occurred in 6.7% of patients, and 3-month case fatality rate was 17.1%. The probability of surviving with modified Rankin Scale score, 0-2 (odds ratio, 0.58 [95% CI, 0.43-0.77]) was significantly lower in patients treated beyond 6 hours as compared with patients treated earlier No differences were found regarding recanalization rates and safety outcomes between patients treated within and beyond 6 hours. There were no differences in outcome between people treated 6-12 hours from onset (278 patients) and those treated 12 to 24 hours from onset (49 patients).

Conclusions: This real-world study suggests that in patients with large vessel occlusion selected on the basis of CT perfusion and collateral circulation assessment, endovascular treatment beyond 6 hours is feasible and safe with no increase in symptomatic intracranial hemorrhage.
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http://dx.doi.org/10.1161/STROKEAHA.119.027974DOI Listing
July 2020

Paralytic ileus after planned abdominal surgery in a patient on treatment with erenumab.

Intern Emerg Med 2021 01 17;16(1):227-228. Epub 2020 Jun 17.

Neuroscience Section, Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila, 67100, L'Aquila, Italy.

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http://dx.doi.org/10.1007/s11739-020-02407-yDOI Listing
January 2021

European headache federation consensus on the definition of resistant and refractory migraine : Developed with the endorsement of the European Migraine & Headache Alliance (EMHA).

J Headache Pain 2020 Jun 16;21(1):76. Epub 2020 Jun 16.

Department of Clinical and Molecular Medicine, Sapienza University of Rome, Rome, Italy.

Introduction: Despite advances in the management of headache disorders, some patients with migraine do not experience adequate pain relief with acute and preventive treatments. It is the aim of the present document to provide a definition of those migraines which are difficult-to-treat, to create awareness of existence of this group of patients, to help Healthcare Authorities in understanding the implications, and to create a basis to develop a better pathophysiological understanding and to support further therapeutic advances.

Main Body: Definitions were established with a consensus process using the Delphi method. Patients with migraine with or without aura or with chronic migraine can be defined as having resistant migraine and refractory migraine according to previous preventative failures. Resistant migraine is defined by having failed at least 3 classes of migraine preventatives and suffer from at least 8 debilitating headache days per month for at least 3 consecutive months without improvement; definition can be based on review of medical charts. Refractory migraine is defined by having failed all of the available preventatives and suffer from at least 8 debilitating headache days per month for at least 6 consecutive months. Drug failure may include lack of efficacy or lack of tolerability. Debilitating headache is defined as headache causing serious impairment to conduct activities of daily living despite the use of pain-relief drugs with established efficacy at the recommended dose and taken early during the attack; failure of at least two different triptans is required.

Conclusions: We hope, that the updated EHF definition will be able to solve the conflicts that have limited the use of definitions which have been put forward in the past. Only with a widely accepted definition, progresses in difficult-to-treat migraine can be achieved. This new definition has also the aim to increase the understanding of the impact of the migraine as a disease with all of its social, legal and healthcare implications. It is the hope of the EHF Expert Consensus Group that the proposed criteria will stimulate further clinical, scientific and social attention to patients who suffer from migraine which is difficult-to-treat.
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http://dx.doi.org/10.1186/s10194-020-01130-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7296705PMC
June 2020

General Anesthesia Versus Conscious Sedation and Local Anesthesia During Thrombectomy for Acute Ischemic Stroke.

Stroke 2020 07 10;51(7):2036-2044. Epub 2020 Jun 10.

NEUROFARBA Department, Careggi University Hospital, Firenze, Italy (S.N., P.N., S.M.).

Background And Purpose: As numerous questions remain about the best anesthetic strategy during thrombectomy, we assessed functional and radiological outcomes in stroke patients treated with thrombectomy in presence of general anesthesia (GA) versus conscious sedation (CS) and local anesthesia (LA).

Methods: We conducted a cohort study on prospectively collected data from 4429 patients enrolled in the Italian Registry of Endovascular Treatment in Acute Stroke.

Results: GA was used in 2013 patients, CS in 1285 patients, and LA in 1131 patients. The rates of 3-month modified Rankin Scale score of 0-1 were 32.7%, 33.7%, and 38.1% in the GA, CS, and LA groups: GA versus CS: odds ratios after adjustment for unbalanced variables (adjusted odds ratio [aOR]), 0.811 (95% CI, 0.602-1.091); and GA versus LA: aOR, 0.714 (95% CI, 0.515-0.990). The rates of modified Rankin Scale score of 0-2 were 42.5%, 46.6%, and 52.4% in the GA, CS, and LA groups: GA versus CS: aOR, 0.902 (95% CI, 0.689-1.180); and GA versus LA: aOR, 0.769 (95% CI, 0.566-0.998). The rates of 3-month death were 21.5%, 19.7%, and 14.8% in the GA, CS, and LA groups: GA versus CS: aOR, 0.872 (95% CI, 0.644-1.181); and GA versus LA: aOR, 1.235 (95% CI, 0.844-1.807). The rates of parenchymal hematoma were 9%, 12.6%, and 11.3% in the GA, CS, and LA groups: GA versus CS: aOR, 0.380 (95% CI, 0.262-0.551); and GA versus LA: aOR, 0.532 (95% CI, 0.337-0.838). After model of adjustment for predefined variables (age, sex, thrombolysis, National Institutes of Health Stroke Scale, onset-to-groin time, anterior large vessel occlusion, procedure time, prestroke modified Rankin Scale score of <1, antiplatelet, and anticoagulant), differences were found also between GA versus CS as regards modified Rankin Scale score of 0-2 (aOR, 0.659 [95% CI, 0.538-0.807]) and GA versus LA as regards death (aOR, 1.413 [95% CI, 1.095-1.823]).

Conclusions: GA during thrombectomy was associated with worse 3-month functional outcomes, especially when compared with LA. The inclusion of an LA arm in future randomized clinical trials of anesthesia strategy is recommended.
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http://dx.doi.org/10.1161/STROKEAHA.120.028963DOI Listing
July 2020

Ischemic Stroke Epidemiology During the COVID-19 Pandemic: Navigating Uncharted Waters With Changing Tides.

Stroke 2020 07 4;51(7):1924-1926. Epub 2020 Jun 4.

Neuroscience Section, Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila, Italy (R.O., S.S.).

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http://dx.doi.org/10.1161/STROKEAHA.120.030791DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7282407PMC
July 2020

Targeting CGRP for migraine treatment: mechanisms, antibodies, small molecules, perspectives.

Expert Rev Neurother 2020 06 2;20(6):627-641. Epub 2020 Jun 2.

Neuroscience Section, Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila , L'Aquila, Italy.

Introduction: Calcitonin Gene-Related Peptide (CGRP) has gradually emerged as a suitable therapeutic target to treat migraine. Considering the social and economic burden of migraine, it is fundamental to optimize the disease management with efficacious and safe treatments. In this scenario, drugs targeting GCRP, monoclonal antibodies (MoAbs) and gepants, represent new therapeutic strategies.

Areas Covered: In the present work, the authors aim at appraising the main insights and implications of treatments targeting CGRP by reviewing pathophysiology and clinical information.

Expert Opinion: Anti-CGRP MoAbs are the first migraine-specific preventive treatments representing a suitable option especially for difficult-to-treat patients. They can be safely administered for long periods even in association with preventatives acting on different targets. Gepants are a safe alternative to triptans for the acute management of migraine and are currently being tested for prevention, thus representing the first transitional molecules for disease therapy. In the future, it might be possible to adapt the treatment according to patients' characteristics and disease phenotype even combining the two treatments targeting the CGRP pathway.
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http://dx.doi.org/10.1080/14737175.2020.1772758DOI Listing
June 2020

Cerebral vascular reactivity and the migraine-stroke relationship: A narrative review.

J Neurol Sci 2020 Jul 6;414:116887. Epub 2020 May 6.

Neurology Section, Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila, Italy.

Migraine, and especially migraine with aura, is associated with an increased risk of stroke and vascular events; however, the reasons for this association are unclear. Several studies evaluated cerebral autoregulation and vasomotor reactivity in patients with migraine compared with non-migraineurs, with conflicting results. Our narrative review aimed at summarizing their results to find the most reliable evidence in the field. Studies which used visual stimuli to evoke vascular responses consistently showed an increased vascular reactivity in migraineurs compared with non-migraineurs, while studies which used systemic stimuli such as hyper- or hypocapnia showed inconsistent results. Therefore, central neural mechanisms might be more important than peripheral vascular mechanisms in determining the cerebral vascular responses of patients with migraine. However, a large body of evidence supports the existence of peripheral vascular dysfunction in patients with migraine. Further studies are needed to explain the complex interactions between central neural and peripheral vascular mechanisms in determining migraine and its vascular risk. Migraine preventive treatments, and especially the most recent ones with a peripheral action, might provide important insights in this field.
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http://dx.doi.org/10.1016/j.jns.2020.116887DOI Listing
July 2020

Sustained response to onabotulinumtoxin A in patients with chronic migraine: real-life data.

J Headache Pain 2020 Apr 25;21(1):40. Epub 2020 Apr 25.

Neuroscience Section, Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila, L'Aquila, Italy.

Background: Treatment with onabotulinumtoxin A (BT-A) is safe and effective for chronic migraine (CM). Several studies assessed possible predictors of response to treatment with BT-A, but there is little knowledge on the frequency and predictors of sustained response. The aim of this study was to evaluate sustained response to BT-A in patients with CM.

Main Body: In this prospective open-label study, 115 patients with CM and treated with BT-A were consecutively enrolled in two Italian headache centers and followed up for 15 months. Anytime responders were defined as those patients who achieved a ≥ 50% reduction in headache days during any three-month treatment cycle compared with the 3 months prior to initiation of BT-A treatment. Sustained responders were defined as those who achieved a ≥ 50% reduction in headache days within the third treatment cycle and maintained response until the end of follow-up. Non-responders were defined as those patients who never achieved a ≥ 50% reduction in headache days during the follow-up. Headache characteristics prior to BT-A treatment were assessed in order to evaluate their ability in predicting treatment response. The 115 enrolled patients (84.3% female; median age 50 years) had a median migraine duration of 30 years (interquartile range 22-38). At the end of follow-up, 66 patients (57.4%) were classified as anytime responders. Among the 51 patients who achieved a clinical response within the third month of treatment, 33 (64.7%) were sustained responders. Patients with sustained response had a lower CM duration (median 31 vs 65 months; P = 0.030) and a lower number of headache days (median 25 vs 30; P = 0.013) at baseline compared with non-responders.

Conclusions: About two thirds of patients who gain ≥50% response to BT-A within the third cycle of treatment maintain this positive response over time. More recent onset of CM and more headache-free days at baseline are associated with sustained response. We suggest not to delay preventive treatment of CM with BT-A, in order to increase the likelihood to achieve sustained clinical response.
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http://dx.doi.org/10.1186/s10194-020-01113-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7183653PMC
April 2020