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Registri di patologia

  • Emanuele Crocetti1

  1. UO Epidemiologia clinica e descrittiva, ISPO Firenze
Emanuele Crocetti -

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Ricerca bibliografica periodo dal 1 febbraio 2014– 15 aprile 2014

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Stringa: (("registries"[MeSH Terms] OR "registries"[All Fields] OR "registry"[All Fields]) OR ("registries"[MeSH Terms] OR "registries"[All Fields])) AND (("italy"[MeSH Terms] OR "italy"[All Fields]) OR italian[All Fields]) AND "humans"[MeSH Terms] AND ("2014/02/01"[PDat] : "2014/04/15"[PDat])
1. Hoff E(1), Eagle T(1), Pyeritz RE(2), Ehrlich M(3), Voehringer M(4), Bossone E(5), Hutchison S(6), Peterson MD(7), Suzuki T(8), Greason K(9), Forteza A(10), Montgomery DG(1), Isselbacher EM(11), Nienaber CA(12), Eagle KA(13). Pulse pressure and type A acute aortic dissection in-hospital outcomes (from the International Registry of Acute Aortic Dissection). Am J Cardiol. 2014 Apr 1;113(7):1255-9. doi: 10.1016/j.amjcard.2013.12.037. Epub 2014 Jan 15.
Author information: (1)Cardiovascular Center, University of Michigan, Ann Arbor, Michigan. (2)Division of Medical Genetics, University of Pennsylvania, Philadelphia, Pennsylvania. (3)Department of Cardiothoracic Surgery, University of Vienna, Vienna, Austria. (4)Department of Cardiology and Pulmonology, Robert-Bosch Krankenhaus, Stuttgart, Germany. (5)Cardiology Division, University of Salerno, Salerno, Italy. (6)Departments of Cardiac Sciences, Medicine and Radiology, University of Calgary, Calgary, Alberta, Canada. (7)Division of Cardiac Surgery, St. Michael's Hospital, Toronto, Ontario, Canada. (8)Department of Cardiovascular Medicine, University of Tokyo, Tokyo, Japan. (9)Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota. (10)Department of Cardiac Surgery, Hospital Universitario "12 de Octubre", Madrid, Spain. (11)Thoracic Aortic Center, Massachusetts General Hospital, Boston, Massachusetts. (12)Department of Internal Medicine, University of Rostock, Rostock, Germany. (13)Cardiovascular Center, University of Michigan, Ann Arbor, Michigan. Electronic address: elisew@umich.edu.

Abstract Little is known about the relation between type A acute aortic dissection (TAAAD) and pulse pressure (PP), defined as the difference between systolic and diastolic blood pressure. In this study, we explored the association between PP and presentation, complications, and outcomes of patients with TAAAD. PP at hospital presentation was used to divide 1,960 patients with noniatrogenic TAAAD into quartiles: narrowed (≤39 mm Hg, n=430), normal (40 to 56 mm Hg, n=554), mildly elevated (57 to 75 mm Hg, n=490), and markedly elevated (≥76 mm Hg, n=486). Variables relating to index presentation and in-hospital outcomes were analyzed. Patients with TAAAD in the narrowed PP quartiles were frequently older and Caucasian, whereas patients with markedly elevated PPs tended to be male and have a history of hypertension. Patients who demonstrated abdominal vessel involvement more commonly demonstrated elevated PPs, whereas patients with narrowed PPs were more likely to have periaortic hematoma and/or pericardial effusion. Narrowed PPs were also correlated with greater incidences of hypotension, cardiac tamponade, and mortality. Patients with TAAAD who were managed with endovascular and hybrid procedures and those with renal failure tended to have markedly elevated PPs. No difference in aortic regurgitation at presentation was noted among groups. In conclusion, patients with TAAAD in the third PP quartile had better in-hospital outcomes than patients in the lowest quartile. Patients with narrowed PPs experienced more cardiac complications, particularly cardiac tamponade, whereas those with markedly elevated PPs were more likely to have abdominal aortic involvement. Presenting PP offers a clue to different manifestations of acute aortic dissection that may facilitate initial triage and care.

2. Vittozzi L(1), Gainotti S, Mollo E, Donati C, Taruscio D. A model for the European platform for rare disease registries. Public Health Genomics. 2013;16(6):299-304. doi: 10.1159/000355935. Epub 2014 Feb 3.
Author information: (1)National Center for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy.

Abstract BACKGROUND: The current situation of rare disease (RD) registries is rather heterogeneous, and new ways to support the registration of RD patients are being sought in the European Union (EU) and the US. The project 'Building Consensus and Synergies for the EU Registration of RD Patients', funded by the EU, aimed to define a model platform for EU RD registries. METHODS: A number of surveys and extensive consultations among registry stakeholders have been carried out to study how the platform can best fulfill their needs. RESULTS: This web-based, multidisease and multipurpose platform is intended to provide a number of functions: a metadata and data repository function supporting the planning of research studies and the production of predefined outputs for the funding organizations and the public, provision of tools and resources of use to registries, promotion of registration and networking among patients and professionals. CONCLUSION: Its main impact is expected to be on data and procedures standardization, on the establishment of new registries, on the sustainability of the smaller ones, and on the registration of those RDs for which a dedicated registry is not sustainable, e.g. ultra-rare diseases or diseases for which there is no special research, clinical or economic interest. It will also impact on the production of sounder information on RD and RD-dedicated health systems, by promoting registry data comparability and quality.

3. Taruscio D(1), Gainotti S, Mollo E, Vittozzi L, Bianchi F, Ensini M, Posada M. . The current situation and needs of rare disease registries in Europe. Public Health Genomics. 2013;16(6):288-98. doi: 10.1159/000355934. Epub 2014 Feb 3
Author information: (1)National Center for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy.

Abstract BACKGROUND: Registries are considered key instruments for developing rare disease (RD) clinical research, enhancing patient care and health planning, and improving social, economic and quality-of-life outcomes. Indeed, it is usually the case that no single institution, and in many cases no single country, has sufficient data to provide results that can be applied broadly to clinical and translational research. However, the fragmentation and heterogeneity of the registries, which are often the result of spontaneous initiatives, limit the general applicability of their observations. METHODS: An inquiry has been carried out by the EPIRARE, a European Union (EU)-funded project ('Building Consensus and Synergies for the EU Registration of Rare Disease Patients') aiming at paving the way to the creation of a European Platform for RD Registries, by means of an on-line questionnaire among European RD registries on their main activities and needs, the way they deal with methodological, technical and regulatory issues and the way they find resources to carry on their activities. RESULTS: In spite of the heterogeneity of the European registries, some elements of relevance for an action to improve the situation of patient registries in the EU are apparent. The needs more frequently indicated by registry holders were financial support, motivation of data providers, data quality assessment, improvement of communication and visibility, and extension of collaborations. Moreover, the registry holders were in favor of a common EU platform providing services for RD registries. CONCLUSION: It appears that the current situation of the European registries provides the transition towards a more uniform, higher quality and better coordinated approach.

4. Taruscio D. Editorial. Public Health Genomics. 2013;16(6):257-8. doi: 10.1159/000355926. Epub 2014 Feb 3.
Author information: National Center for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy.
5. Arbyn M(1), Verdoodt F(2), Snijders PJ(3), Verhoef VM(3), Suonio E(4), Dillner L(5), Minozzi S(6), Bellisario C(6), Banzi R(7), Zhao FH(8), Hillemanns P(9), Anttila A(10). Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol. 2014 Feb;15(2):172-83. doi: 10.1016/S1470-2045(13)70570-9. Epub 2014 Jan 14.
Author information: (1)Unit of Cancer Epidemiology, Scientific Institute of Public Health, Brussels, Belgium. Electronic address: marc.arbyn@wiv-isp.be. (2)Unit of Cancer Epidemiology, Scientific Institute of Public Health, Brussels, Belgium. (3)Department of Pathology, VU University Medical Center, Amsterdam, Netherlands. (4)International Agency for Research on Cancer, Lyon, France. (5)Karolinska Institute, Stockholm, Sweden. (6)Unit of Cancer Epidemiology, Department of Oncology, Piedmont Centre for Cancer Prevention, S Giovanni University Hospital, Turin, Italy. (7)IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy. (8)Department of Cancer Epidemiology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China. (9)Department of Gynaecology and Obstetrics, Hannover Medical School, Hannover, Germany. (10)Finnish Cancer Registry, Helsinki, Finland. Comment in Lancet Oncol. 2014 Feb;15(2):128-9.

Abstract BACKGROUND: Screening for human papillomavirus (HPV) infection is more effective in reducing the incidence of cervical cancer than screening using Pap smears. Moreover, HPV testing can be done on a vaginal sample self-taken by a woman, which offers an opportunity to improve screening coverage. However, the clinical accuracy of HPV testing on self-samples is not well-known. We assessed whether HPV testing on self-collected samples is equivalent to HPV testing on samples collected by clinicians. METHODS: We identified relevant studies through a search of PubMed, Embase, and CENTRAL. Studies were eligible for inclusion if they fulfilled all of the following selection criteria: a cervical cell sample was self-collected by a woman followed by a sample taken by a clinician; a high-risk HPV test was done on the self-sample (index test) and HPV-testing or cytological interpretation was done on the specimen collected by the clinician (comparator tests); and the presence or absence of cervical intraepithelial neoplasia grade 2 (CIN2) or worse was verified by colposcopy and biopsy in all enrolled women or in women with one or more positive tests. The absolute accuracy for finding CIN2 or worse, or CIN grade 3 (CIN3) or worse of the index and comparator tests as well as the relative accuracy of the index versus the comparator tests were pooled using bivariate normal models and random effect models. FINDINGS: We included data from 36 studies, which altogether enrolled 154 556 women. The absolute accuracy varied by clinical setting. In the context of screening, HPV testing on self-samples detected, on average, 76% (95% CI 69-82) of CIN2 or worse and 84% (72-92) of CIN3 or worse. The pooled absolute specificity to exclude CIN2 or worse was 86% (83-89) and 87% (84-90) to exclude CIN3 or worse. The variation of the relative accuracy of HPV testing on self-samples compared with tests on clinician-taken samples was low across settings, enabling pooling of the relative accuracy over all studies. The pooled sensitivity of HPV testing on self-samples was lower than HPV testing on a clinician-taken sample (ratio 0•88 [95% CI 0•85-0•91] for CIN2 or worse and 0•89 [0•83-0•96] for CIN3 or worse). Also specificity was lower in self-samples versus clinician-taken samples (ratio 0•96 [0•95-0•97] for CIN2 or worse and 0•96 [0•93-0•99] for CIN3 or worse). HPV testing with signal-based assays on self-samples was less sensitive and specific than testing on clinician-based samples. By contrast, some PCR-based HPV tests generally showed similar sensitivity on both self-samples and clinician-based samples. INTERPRETATION: In screening programmes using signal-based assays, sampling by a clinician should be recommended. However, HPV testing on a self-sample can be suggested as an additional strategy to reach women not participating in the regular screening programme. Some PCR-based HPV tests could be considered for routine screening after careful piloting assessing feasibility, logistics, population compliance, and costs. FUNDING: The 7th Framework Programme of the European Commission, the Belgian Foundation against Cancer, the International Agency for Research on Cancer, and the German Guideline Program in Oncology.

6. Di Bartolomeo S(1), Marino M, Valent F, De Palma R. Effects of anticoagulant and antiplatelet drugs on the risk for hospital admission for traumatic injuries: a case-control and population-based study. J Trauma Acute Care Surg. 2014 Feb;76(2):437-42. doi: 10.1097/TA.0b013e3182aa80f9.
Author information: (1)From the Regional Agency for Health and Social Care of Emilia-Romagna (M.M., R.D.P.)/Azienda Ospedaliero (S.D.B.), Universitaria di Udine, Bologna; and Servizio di epidemiologia (F.V.), Direzione centrale salute, integrazione sociosanitaria e politiche sociali, Regione autonoma Friuli Venezia Giulia, Italy.

Abstract BACKGROUND: The current cardiovascular literature advocates an overall beneficial balance between the advantages of oral anticoagulants and antiplatelet drugs in preventing and treating thromboembolic events and their disadvantages in promoting hemorrhage. However, traumatic injuries have usually received little attention despite several studies from the surgical literature showing worse outcomes in anticoagulated trauma registry patients. To quantify at population level too this seemingly deleterious impact, we investigated the effects of anticoagulants and antiplatelet use on the risk for hospital admission for acute traumatic causes. METHODS: A population-based, case-control study in an Italian region with 4.5 million inhabitants was conducted. Cases were all the 59,348 adult residents admitted to the hospital for traumatic injuries in the years 2010 and 2011. Controls were age- and sex-matched residents selected by incidence density sampling. By conditional logistic regression adjusted for comorbidities, we estimated the risk for traumatic hospital admission while on anticoagulant, antiplatelet, and combined medications. RESULTS: The odds ratios (ORs) for anticoagulation and combined medications were 1.21 (95% confidence interval [CI], 1.15-1.28) and 1.39 (95% CI, 1.21-1.62). These effects were generally consistent across subgroups of demographic and clinical characteristics and particularly important in the head injured (e.g., OR for anticoagulation, 2.00; 95% CI, 1.77-12.27). Antiplatelets alone had no overall effect (OR, 1.02; 95% CI, 0.99-1.05). The number-needed-to-harm of anticoagulation was 595. CONCLUSION: Oral anticoagulation increased the population risk for traumatic hospital admission, with a further increase in case of concurrent antiplatelet use. Because this effect is most likely to derive from the prohemorrhagic properties of these drugs, injured patients should be included in the future evaluations of the cost-benefit profiles of these medications. LEVEL OF EVIDENCE: Epidemiologic/prognostic study, level III.

7. Pupillo E(1), Messina P, Logroscino G, Beghi E; SLALOM Group. Long-term survival in amyotrophic lateral sclerosis: a population-based study. Ann Neurol. 2014 Feb;75(2):287-97. doi: 10.1002/ana.24096. Epub 2014 Feb 24.
Collaborators: Micheli A, Rosettani P, Baldini D, Bianchi G, Rigamonti A, Bonito V, Chiveri L, Guidotti M, Rezzonico M, Vidale S, Corbo M, Lunetta C, Maestri E, Cotelli MS, Filosto M, Filippini G, Lauria G, Mora G, Papetti L, Morelli C, Perini M, Tavernelli F, Perrone P, Guaita MC, Testa D, Sasanelli F, Galbussera A, Tremolizzo L, Ferrarese C, Galli A, Vitelli E, Prelle A, Riva N, Ceroni M, Delodovici L, Clerici M, Bono G, Buzzi P, Previdi P, Guarneri G, Abruzzi L, Riccardi T, Lorusso L, Mazzini L. Author information: (1)Department of Neurosciences, IRCSS, Mario Negri Institute of Pharmacological Research, Milan.

Abstract OBJECTIVE: To determine the long-term survival in amyotrophic lateral sclerosis (ALS) and identify predictors of prolonged survival in a population-based cohort of newly diagnosed patients. METHODS: An incident cohort from a population-based registry during the years 1998 through 2002 in Lombardy, Italy was followed until death or to February 28, 2013. Age, sex, date of onset of symptoms, site of onset, date of diagnosis, and El Escorial diagnostic category were collected. Survival was assessed using Kaplan-Meier curves. Cox proportional hazards function was used to identify independent prognostic predictors. Standardized mortality ratios (SMRs) were used to assess the 5-year and 10-year excess mortality of ALS patients. RESULTS: Included were 280 men and 203 women aged 18 to 93 years. Spinal onset ALS was present in 312 cases (64.6%). Definite ALS was diagnosed in 213 cases (44.1%), probable ALS in 130 (26.9%), possible ALS in 93 (19.3%), and suspected ALS in 47 (9.7%). The cumulative time-dependent survival at 1, 5, and 10 years from diagnosis was 76.2%, 23.4%, and 11.8%, respectively. Independent predictors included younger age, the diagnosis of possible/suspected ALS, spinal onset, and symptoms having started >12 months previously at diagnosis. SMR was 9.4 at 5 years and 5.4 at 10 years. SMR at 10 years was higher until age 75 year, predominating in women, and became nonsignificant for males thereafter. INTERPRETATION: The outcome in ALS varies with phenotype. Longer survival is predicted by younger age, spinal onset, male gender, and suspected ALS. After age 75 years, 10-year survival in men with ALS is similar to the general population.

8. Ballotta E(1), Toniato A(2), Piatto G(2), Mazzalai F(2), Da Giau G(2). Lower extremity arterial reconstruction for critical limb ischemia in diabetes. J Vasc Surg. 2014 Mar;59(3):708-19. doi: 10.1016/j.jvs.2013.08.103. Epub 2013 Dec 28.
Author information: (1)2nd Surgical Clinic, Vascular Surgery Group, Department of Surgical, Oncological and Gastroenterological Sciences, University of Padua, School of Medicine, Padova, Italy. Electronic address: enzo.ballotta@unipd.it. (2)2nd Surgical Clinic, Vascular Surgery Group, Department of Surgical, Oncological and Gastroenterological Sciences, University of Padua, School of Medicine, Padova, Italy.

Abstract BACKGROUND: The impact of diabetes mellitus on the technical and clinical outcomes of infrainguinal arterial reconstruction (IAR) for critical limb ischemia (CLI) remains controversial. This study analyzed the outcome of IAR in diabetic patients with CLI over a 17-year period. METHODS: Details on all consecutive patients undergoing primary IAR at our institution were stored prospectively in a vascular registry from 1995 to 2011. Demographics, risk factors, indications for surgery, inflow sources and outflow target vessels, types of conduit, and adverse outcomes were analyzed. Postoperative surveillance included clinical examination, duplex scans, and ankle-brachial index measurements in all patients at discharge, 1 and 6 months after surgery, and every 6 months thereafter. End points were patency, limb salvage, survival, and amputation-free survival rates, and were assessed using Kaplan-Meier life-table analysis. The χ(2) or Fisher exact, Student t, and log-rank tests were used to establish statistical significance. RESULTS: Overall, 1407 IARs were performed in 1310 patients with CLI by the same surgeon, 705 (50.2%) in 643 diabetic patients and 702 in 667 nondiabetic patients. Autogenous vein conduits were used in 87% of the IARs. There were no perioperative deaths. Diabetic patients had significantly more major (16.7% vs 11.8%; P = .02) and minor complications (9.7% vs 6.5%; P = .02) than nondiabetic patients. At 5 and 10 years, there were no significant differences between diabetic and nondiabetic patients in the rates of primary patency (65% and 46% vs 69.5% and 57%; log-rank test, P = .09), secondary patency (76% and 60% vs 80% and 68%; log-rank test, P = .20), limb salvage (88% and 76% vs 91% and 83%; log-rank test, P = .12) survival (51% and 34% vs 57% and 38%; log-rank test, P = .41), or amputation-free survival (45.5% and 27% vs 51% and 29%; log-rank test, P = .19). The type of conduit did not affect patency or limb salvage rates in either group. CONCLUSIONS: Diabetic patients receiving IAR for CLI can have the same survival and amputation-free survival rates as nondiabetic patients. Their comparable technical and clinical outcomes strongly demonstrate that diabetics with CLI can expect the same quantity and quality of life as nondiabetics with CLI, and aggressive attempts at limb salvage in patients with diabetes mellitus, including distal and foot level bypass grafting, should not be discouraged.

9. Le Cornet C(1), Lortet-Tieulent J(2), Forman D(2), Béranger R(3), Flechon A(4), Fervers B(5), Schüz J(6), Bray F(2). Testicular cancer incidence to rise by 25% by 2025 in Europe? Model-based predictions in 40 countries using population-based registry data. Eur J Cancer. 2014 Mar;50(4):831-9. doi: 10.1016/j.ejca.2013.11.035. Epub 2013 Dec 23.
Author information: (1)Section of Environment and Radiation, International Agency for Research on Cancer, 150 Cours Albert Thomas, 69372 Lyon CEDEX 08, France; Unité Cancer et Environnement, Centre Léon Bérard, 28 rue Laennec, 69373 Lyon CEDEX 08, France. Electronic address: Lecornetc@students.iarc.fr. (2)Section of Cancer Information, International Agency for Research on Cancer, 150 Cours Albert Thomas, 69372 Lyon CEDEX 08, France. (3)Section of Environment and Radiation, International Agency for Research on Cancer, 150 Cours Albert Thomas, 69372 Lyon CEDEX 08, France; Unité Cancer et Environnement, Centre Léon Bérard, 28 rue Laennec, 69373 Lyon CEDEX 08, France; Université Claude Bernard - Lyon1, 43 Boulevard du 11 Novembre 1918, 69622 Villeurbanne CEDEX, France. (4)Centre de Lutte Contre le Cancer, Centre Léon Bérard, 28 rue Laennec, 69373 Lyon CEDEX 08, France. (5)Unité Cancer et Environnement, Centre Léon Bérard, 28 rue Laennec, 69373 Lyon CEDEX 08, France; Université Claude Bernard - Lyon1, 43 Boulevard du 11 Novembre 1918, 69622 Villeurbanne CEDEX, France; Centre de Lutte Contre le Cancer, Centre Léon Bérard, 28 rue Laennec, 69373 Lyon CEDEX 08, France. (6)Section of Environment and Radiation, International Agency for Research on Cancer, 150 Cours Albert Thomas, 69372 Lyon CEDEX 08, France.

Abstract BACKGROUND: Testicular cancer mainly affects White Caucasian populations, accounts for 1% of all male cancers, and is frequently the most common malignancy among young adult men. In light of the escalating rates of testicular cancer incidence in Europe, and in support of future planning to ensure optimal care of patients with what can be a curable disease, we predict the future burden in 40 European countries around 2025. METHODS: Current observed trends were extrapolated with the NORDPRED model to estimate the future burden of testicular cancer in the context of changes in risk versus changes in demographics. FINDINGS: Despite substantial heterogeneity in the rates, the vast majority of European countries will see an increasing burden over the next two decades. We estimate there will be 23,000 new cases of testicular cancer annually in Europe by 2025, a rise of 24% from 2005. Some of the most rapid increases in testicular cancer are observed in Croatia, Slovenia, Italy and Spain, and a transition is underway, whereby recent attenuations and declines in rates in certain high-risk countries in Northern Europe contrast with the increasing trends and escalating burden in Southern Europe. According to our estimates for 2025, around one in 100 men will be diagnosed with the disease annually in the highest risk countries of Europe (Croatia, Slovenia and Norway). INTERPRETATION: Elucidating the key determinants of testicular cancer and the equitable provision of optimal care for patients across Europe are priorities given the steady rise in the number of patients by 2025, and an absence of primary prevention opportunities. FUNDING: None.

10. Piaserico S(1), Cazzaniga S(2), Chimenti S(3), Giannetti A(4), Maccarone M(5), Picardo M(6), Peserico A(7), Naldi L(2); Psocare Study Group. Efficacy of switching between tumor necrosis factor-alfa inhibitors in psoriasis: results from the Italian Psocare registry. J Am Acad Dermatol. 2014 Feb;70(2):257-62.e3. doi: 10.1016/j.jaad.2013.10.019. Epub 2013 Dec 16.
Collaborators: Griseta V, Miracapillo A, Azzini M, Mocci L, Michelini M, Offidani A, Bernardini L, Campanati A, Ricotti G, Giacchetti A, Norat M, Gualco F, Castelli A, Cuccia A, Diana A, Roncarolo G, Belli MA, Baldassarre MA, Santoro G, Vena GA, Lo Console F, Filotico R, Mastrandrea V, Brunetti B, Musumeci F, Carrabba E, Dal Mas P, Annicchiarico F, Benvegnù B, Spaziani G, Cusano F, Iannazzone S, Galluccio A, Pezza M, Marchesi L, Imberti G, Reseghetti A, Barbera C, Reggiani M, Lanzoni A, Patrizi A, Bardazzi F, Antonucci A, De Tommaso S, Balestri R, Wallnofer W, Ingannamorte F, Calzavara-Pinton P, Iannazzi S, Zane C, Capezzera R, Bassisi S, Rossi MT, Altamura V, Vigl W, Nobile C, Aste N, Murgia S, Mugheddu C, Scuderi G, Baglieri F, Di Dio C, Grilli E, Mastronardi C, Agnusdei CP, Antrilli A, Aulisa L, Raimondo U, di Luzio G, Battarra VC, Farro P, Plaitano R, Micali G, Musumeci ML, Massimino D, Li Calzi M, La Greca S, Pettinato M, Sapienza G, Valenti G, De Giacomo PF, d'Amico D, Arcangeli F, Brunelli D, Ghetti E, Tulli A, Assi G, Amerio P, Laria G, Prestinari F, Spadafora S, Coppola M, Caresana G, Pezzarossa E, Domaneschi E, Felisi C, Donato L, Bertero M, Musso L, lazzini SP, Bruscino P, Agozzino UC, Ottaviani M, Simoncini C, Virgili A, Osti F, Fabbri P, Volpi W, Caproni M, Lotti T, Prignano F, Buggiani G, Troiano M, Fenizi G, Altobella A, Amoruso A, Condello M, Goffredo A, Righini MG, Alessandrini F, Satolli F, Zampetti M, Bertani E, Fossati S, Parodi A, Burlando M, Fiorucci C, Nigro A, Ghigliotti G, Massone L, Moise GM, Serrai M, Cannata G, Campagnoli AM, Daly M, Leporati C, Peila R, Filosa G, Bugatti L, Nicolini M, Nazzari G, Cestari R, Anastasio F, Larussa FM, Pollice N, De Francesco F, Mazzocchetti G, Peris K, Fargnoli MC, Di Cesare A, De Angelis L, Flati G, Biamonte AS, Quarta G, Congedo M, Carcaterra A, Strippoli D, Fideli D, Marsili F, Celli M, Ceccarini M, Bachini L, D'Oria M, Schirripa V, De Filippi C, Martini P, Lapucci E, Mazzatenta C, Ghilardi A, Simonacci M, Bettacchi A, Gasco R, Zanca A, Battistini S, Dattola S, Vernaci R, Postorino F, Zampieri PF, Padovan C, Intchaurraga MA, Ladurner J, Guarneri B, Cannavò S, Manfrè C, Borgia F, Guerra A, Sedona P, Cattaneo A, Carrera C, Fracchiolla C, Mozzanica N, Prezzemolo L, Menni S, Lodi A, Martino P, Monti M, Mancini L, Sacrini F, Altomare GF, Taglioni M, Lovati C, Mercuri SR, Schiesari G, Giannetti A, Conti A, Lasagni C, Greco M, Ronsini G, Schianchi S, Fiorentini C, Niglietta S, Maglietta R, Padalino C, Crippa D, Pini M, Rossi E, Tosi D, Armas M, Ruocco V, Ayala F, Balato N, Gaudiello F, Cimmino GF, Monfrecola G, Gallo L, Argenziano G, Fulgione E, Berruti G, Ceparano S, De Michele I, Giorgiano D, Leigheb G, Deledda S, Peserico A, Alaibac M, Piaserico S, Schiesari L, Dan G, Mattei I, Oro E, Aricò M, Bongiorno MR, Angileri R, Amato S, Todaro F, Milioto M, Bellastro R, Di Nuzzo S, De Panfilis G, Zanni M, Borroni G, Cananzi R, Brazzelli V, Lisi P, Stingeni L, Hansel K, Pierfelice V, Donelli S, Rastelli D, Gasperini M, Barachini P, Cecchi R, Bartoli L, Pavesi M, De Paola S, Corradin MT, Ricciuti F, Piccirillo A, Viola L, Tataranni M, Mautone MG, Lo Scocco G, Niccoli MC, Vernetti AM, Gaddoni G, Resta F, Casadio MC, Arcidiaco MC, Luvarà MC, Albertini G, Di Lernia V, Guareschi E, Catrani S, Morri M, Amerio P, De Simone C, D'Agostino M, Agostino I, Calvieri S, Cantoresi F, Richetta A, Sorgi P, Carnevale C, Nicolucci F, Berardesca E, Ardigò M, De Felice C, Gubinelli E, Chimenti S, Talamonti M, Camplone G, Cruciani G, Riccardi F, Barbati R, Zumiani G, Pagani W, Malagoli PG, Pellicano R, Donadio D, Di Vito C, Cottoni F, Montesu MA, Pirodda C, Addis G, Marongiu P, Farris A, Cacciapuoti M, Verrini A, Desirello G, Gnone M, Fimiani M, Pellegrino M, Castelli G, Zappalà L, Sesana G, Ingordo V, Vozza E, Di Giuseppe D, Fasciocco D, Nespoli P, Papini M, Cicoletti M, Bernengo MG, Ortoncelli M, Bonvicino A, Capella G, Doveil GC, Forte M, Peroni A, Salomone B, Savoia P, Pippione M, Zichichi L, Frazzitta M, De Luca G, Zumiani G, Tasin L, Simonetto D, Ros S, Trevisan G, Patamia M, Miertusova S, Patrone P, Frattasio A, Piccirillo F, La Spina S, Di Gaetano L, Marzocchi V, Motolese A, Venturi C, Sedona P, Gai F, Pasquinucci S, Bellazzi RM, Silvestri T, Girolomoni G, Gisondi P, Fornasa C, Trevisan GP. Author information: (1)Dermatology Unit, Department of Medicine, University of Padua, Padua, Italy. Electronic address: stefano.piaserico@unipd.it. (2)Centro Studi Gruppo Italiano Studi In Epidemiologia (GISED), Papa Giovanni XXIII Hospital, Bergamo, Italy. (3)Department of Dermatology, University of Rome "Tor Vergata", Rome, Italy. (4)Department of Dermatology, University of Modena and Reggio Emilia, Modena, Italy. (5)Italian Psoriatic Patient Association (Associazione Difesa Pazienti Psoriasici [ADIPSO]), Rome, Italy. (6)Laboratory of Cutaneous Physiopathology, San Gallicano Dermatological Institute Rome, Rome, Italy. (7)Dermatology Unit, Department of Medicine, University of Padua, Padua, Italy.

Abstract BACKGROUND: Some studies have shown that switching patients from one tumor necrosis factor (TNF)-alfa inhibitor to another may be beneficial when they have an inadequate response or an adverse event. OBJECTIVE: We sought to assess the variables predicting the efficacy of the second TNF-alfa inhibitor in patients discontinuing the first TNF-alfa inhibitor. METHODS: Data from all 5423 consecutive patients starting TNF-alfa inhibitor therapy for psoriasis between September 2005 and September 2010 who were included in the Italian Psocare registry were analyzed. RESULTS: In 105 patients who switched to a second TNF-alfa inhibitor who had complete follow-up data, 75% improvement in the Psoriasis Area Severity Index score (PASI 75) was reached by 29% after 16 weeks and by 45.6% after 24 weeks. Patients who switched because of secondary loss of efficacy (loss of initial PASI 75 response) or adverse events/intolerance were more likely to reach PASI 75 than those who switched as a result of primary inefficacy (PASI 75 never achieved) (hazard ratio 2.7, 95% confidence interval 1.3-5.5 vs hazard ratio 2.0, 95% confidence interval 1.0-3.9 and 1, respectively). LIMITATIONS: There was a small number of patients with complete follow-up data. CONCLUSION: PASI 75 response in patients who switched from one anti-TNF-alfa agent to another was significantly reduced in patients who showed primary inefficacy of the first anti-TNF-alfa.

11. Shah R(1), Gayat E(2), Januzzi JL Jr(3), Sato N(4), Cohen-Solal A(5), diSomma S(6), Fairman E(7), Harjola VP(8), Ishihara S(9), Lassus J(10), Maggioni A(11), Metra M(12), Mueller C(13), Mueller T(14), Parenica J(15), Pascual-Figal D(16), Peacock WF(17), Spinar J(15), van Kimmenade R(18), Mebazaa A(10); GREAT (Global Research on Acute Conditions Team) Network. Body mass index and mortality in acutely decompensated heart failure across the world: a global obesity paradox. J Am Coll Cardiol. 2014 Mar 4;63(8):778-85. doi: 10.1016/j.jacc.2013.09.072. Epub 2013 Dec 4.
Author information: (1)Cardiology Division, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts. (2)Department of Anesthesiology and Intensive Care, Lariboisière University Hospital, Assistance Publique-Hôpitaux de Paris, Université Paris Diderot, Paris, France. (3)Cardiology Division, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts. Electronic address: jjanuzzi@partners.org. (4)Internal Medicine, Cardiology, and Intensive Care Medicine, Nippon Medical School Musashi-Kosugi Hospital, Tokyo, Japan. (5)Biomarkers and Heart Diseases, UMR-942, Institut National de la Santé et de la Recherche Médicale (INSERM), Paris, France. (6)Emergency Department, Sant'Andrea Hospital, University La Sapienza, Rome, Italy. (7)Sociedad Argentina de Cardiologia, Area de Investigacion SAC Azcuenaga, Buenos Aires, Argentina. (8)Division of Emergency Care, Helsinki University Central Hospital, Helsinki, Finland. (9)Department of Cardiology, Steel Memorial Yawata Hospital, Kitakyushu, Japan. (10)Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland. (11)ANMCO Research Center, Firenze, Italy. (12)Cardiology, Department of Experimental and Applied Medicine, University of Brescia, Brescia, Italy. (13)Department of Internal Medicine, University Hospital, Basel, Switzerland. (14)Department of Laboratory Medicine, Konventhospital Barmherzige Brueder, Linz, Austria. (15)Department of Internal Medicine and Cardiology, University Hospital Brno, Faculty of Medicine, Masaryk University, Brno, Czech Republic. (16)Cardiology Service, Virgen de la Arrixaca Hospital, Department of Medicine, Faculty of Medicine, University Murcia, Murcia, Spain. (17)Baylor College of Medicine, Houston, Texas. (18)University Medical Center, Utrecht, Utrecht, the Netherlands. Comment in J Am Coll Cardiol. 2014 Mar 4;63(8):786-7.

Abstract OBJECTIVES: This study sought to define the relationship between body mass index (BMI) and mortality in heart failure (HF) across the world and to identify specific groups in whom BMI may differentially mediate risk. BACKGROUND: Obesity is associated with incident HF, but it is paradoxically associated with better prognosis during chronic HF. METHODS: We studied 6,142 patients with acute decompensated HF from 12 prospective observational cohorts followed-up across 4 continents. Primary outcome was all-cause mortality. Cox proportional hazards models and net reclassification index described associations of BMI with all-cause mortality. RESULTS: Normal-weight patients (BMI 18.5 to 25 kg/m(2)) were older with more advanced HF and lower cardiometabolic risk. Despite worldwide heterogeneity in clinical features across obesity categories, a higher BMI remained associated with decreased 30-day and 1-year mortality (11% decrease at 30 days; 9% decrease at 1 year per 5 kg/m(2); p < 0.05), after adjustment for clinical risk. The BMI obtained at index admission provided effective 1-year risk reclassification beyond current markers of clinical risk (net reclassification index 0.119, p < 0.001). Notably, the "protective" association of BMI with mortality was confined to persons with older age (>75 years; hazard ratio [HR]: 0.82; p = 0.006), decreased cardiac function (ejection fraction <50%; HR: 0.85; p < 0.001), no diabetes (HR: 0.86; p < 0.001), and de novo HF (HR: 0.89; p = 0.004). CONCLUSIONS: A lower BMI is associated with age, disease severity, and a higher risk of death in acute decompensated HF. The "obesity paradox" is confined to older persons, with decreased cardiac function, less cardiometabolic illness, and recent-onset HF, suggesting that aging, HF severity/chronicity, and metabolism may explain the obesity paradox.

12. Conrotto F(1), D'Ascenzo F(2), Giordana F(2), Salizzoni S(3), Tamburino C(4), Tarantini G(5), Presbitero P(6), Barbanti M(4), Gasparetto V(5), Mennuni M(6), Napodano M(5), Rossi ML(6), La Torre M(3), Ferraro G(7), Omedè P(2), Scacciatella P(7), Marra WG(2), Colaci C(2), Biondi-Zoccai G(8), Moretti C(2), D'Amico M(7), Rinaldi M(3), Gaita F(2), Marra S(7). Impact of diabetes mellitus on early and midterm outcomes after transcatheter aortic valve implantation (from a multicenter registry). Am J Cardiol. 2014 Feb 1;113(3):529-34. doi: 10.1016/j.amjcard.2013.10.025. Epub 2013 Nov 11.
Author information: (1)Division of Cardiology 2, Città della Salute e della Scienza Hospital, Turin, Italy. Electronic address: federico.conrotto@gmail.com. (2)Division of Cardiology 1, Città della Salute e della Scienza Hospital, Turin, Italy. (3)Division of Cardiac Surgery, Città della Salute e della Scienza Hospital, Turin, Italy. (4)Ferrarotto Hospital, University of Catania, Catania, Italy. (5)Division of Cardiology, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padova, Italy. (6)Division of Cardiology, Istituto Humanitas, Milan, Italy. (7)Division of Cardiology 2, Città della Salute e della Scienza Hospital, Turin, Italy. (8)Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Rome, Italy.

Abstract Several clinical and procedural factors have been identified as predictors of early and midterm events after transcatheter aortic valve implantation (TAVI), but incidence and prognostic impact of diabetes mellitus (DM), especially insulin treated, on short- and midterm outcomes remain to be defined. All consecutive patients who underwent TAVI at our institutions were enrolled and stratified according to DM status. All-cause mortality at 30 days or in hospital and at follow-up was the primary end point, whereas periprocedural complications, rates of myocardial infarction, stroke, and reintervention at follow-up were the secondary ones. All end points were adjudicated according to the Valve Academic Research Consortium definitions. In all, 511 patients were enrolled: 361 without DM, 78 with orally treated DM, and 72 with insulin-treated DM. Orally treated DM patients were more frequently women, whereas insulin-treated DM patients were younger. Thirty-day Valve Academic Research Consortium mortality was not significantly higher in patients with orally treated DM and insulin-treated DM compared with patients without diabetes (6.4%, 9.7%, and 4.7%, p = 0.09). Bleedings, vascular complications, postprocedural acute kidney injury, and periprocedural strokes were not significantly different in the 3 groups. At midterm follow-up (median 400 days), patients with insulin-treated DM had a significantly higher mortality rate (33.3% vs 18.6%, p = 0.01) and higher myocardial infarction incidence (8.3% vs 1.4%, p = 0.002) if compared with patients without diabetes. Strokes and reinterventions at follow-up were similar in the 3 groups. After multivariable adjustment, insulin-treated DM was independently correlated with death (hazard ratio 2, 95% confidence interval 1.3 to 3.3) and myocardial infarction (hazard ratio 3.73, 95% confidence interval 1.1 to 13). In conclusion, DM does not significantly affect rates of complications in patients who underwent TAVI. Insulin-treated DM, but not orally treated DM, is independently associated with death and myocardial infarction at midterm follow-up and should be included into future TAVI-dedicated scores.

13. Cox K(1), Bryce J, Jiang J, Rodie M, Sinnott R, Alkhawari M, Arlt W, Audi L, Balsamo A, Bertelloni S, Cools M, Darendeliler F, Drop S, Ellaithi M, Guran T, Hiort O, Holterhus PM, Hughes I, Krone N, Lisa L, Morel Y, Soder O, Wieacker P, Ahmed SF. Novel associations in disorders of sex development: findings from the I-DSD Registry. J Clin Endocrinol Metab. 2014 Feb;99(2):E348-55. doi: 10.1210/jc.2013-2918. Epub 2013 Dec 3.
Author information: (1)University of Glasgow (K.C., J.B., J.J., M.R., R.S., S.F.A.), Child Health, School of Medicine, Royal Hospital for Sick Children, Yorkhill, and National eScience Centre, Glasgow G3 8SJ, United Kingdom; University of Melbourne (R.S.), eResearch, Melbourne, Parkville VIC 3010, Australia; Al-Amiri Hospital (M.A.), Paediatric Department, MOH, Safat 13015, Kuwait; University of Birmingham (W.A., N.K.), Centre for Endocrinology, Diabetes and Metabolism, School of Clinical & Experimental Medicine, Birmingham B15 2TT, United Kingdom; Vall d'Hebron Research Institute (L.A.) and CIBERER, Barcelona, 08035 Spain; University of Bologna (A.B.), Department of Gynecologic, Obstetric and Pediatric Sciences, Operative Unit Pediatrics, 40138, Bologna, Italy; University Hospital Pisa (S.B.), Servizio di Medicina dell'Adolescenza - UO Pediatria, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy; University Hospital Ghent & University of Ghent (M.C.), Department of Pediatric and Adolescent Endocrinology and Diabetology, 185-9000 Gent, Belgium; Istanbul University (F.D.), Istanbul Faculty of Medicine, Department of Pediatrics, Pediatric Endocrinology Unit, 34452 İstanbul, Turkey; Sophia Children's Hospital/Erasmus MC (S.D.), Division of Pediatric Endocrinology, Department of Pediatrics, Rotterdam, The Netherlands; Al-Neelain Medical Research Centre (M.E.), Faculty of Medicine and Health Sciences, Al-Neelain University and Biotechnology Lab, Ahfad University for Women, 00249 Khartoum, Sudan; Marmara University Hospital (T.G.), Istanbul, Pediatric Endocrinology and Diabetes, Fevzi Cakmak Mh. 34899 Ustkaynarca/Pendik-Istanbul-Turkey; University of Lübeck (O.H.), Division of Experimental Paediatric Endocrinology and Diabetes, Department of Paediatrics and Adolescent Medicine, 23560 Lübeck, Germany; University Hospital of Schleswig Holstein (P.-M. H.), Department of General Pediatrics, University of Kiel, 24105 Kiel, Germany; University of Cambridge (I.H.), Department of Paediatri Comment in Nat Rev Endocrinol. 2014 Mar;10(3):127.

Abstract CONTEXT: The focus of care in disorders of sex development (DSD) is often directed to issues related to sex and gender development. In addition, the molecular etiology remains unclear in the majority of cases. OBJECTIVE: To report the range of associated conditions identified in the international DSD (I-DSD) Registry. DESIGN, SETTING, AND PATIENTS: Anonymized data were extracted from the I-DSD Registry for diagnosis, karyotype, sex of rearing, genetic investigations, and associated anomalies. If necessary, clarification was sought from the reporting clinician. RESULTS: Of 649 accessible cases, associated conditions occurred in 168 (26%); 103 (61%) cases had one condition, 31 (18%) had two conditions, 20 (12%) had three conditions, and 14 (8%) had four or more conditions. Karyotypes with most frequently reported associations included 45,X with 6 of 8 affected cases (75%), 45,X/46,XY with 19 of 42 cases (45%), 46,XY with 112 of 460 cases (24%), and 46,XX with 27 of 121 cases (22%). In the 112 cases of 46,XY DSD, the commonest conditions included small for gestational age in 26 (23%), cardiac anomalies in 22 (20%), and central nervous system disorders in 22 (20%), whereas in the 27 cases of 46,XX DSD, skeletal and renal anomalies were commonest at 12 (44%) and 8 (30%), respectively. Of 170 cases of suspected androgen insensitivity syndrome, 19 (11%) had reported anomalies and 9 of these had confirmed androgen receptor mutations. CONCLUSIONS: Over a quarter of the cases in the I-DSD Registry have an additional condition. These associations can direct investigators toward novel genetic etiology and also highlight the need for more holistic care of the affected person.

14. Zipfel B(1), Chiesa R(2), Kahlberg A(2), Marone EM(2), Rousseau H(3), Kaskarelis I(4), Riambau V(5), Coppi G(6), Ferro C(7), Sassi C(8), Esteban C(9), Mangialardi N(10), Tealdi DG(11), Nano G(11), Schoder M(12), Funovics M(12), Buz S(13), Hetzer R(13); RESTORE Investigators. Endovascular repair of traumatic thoracic aortic injury: final results from the relay endovascular registry for thoracic disease. Ann Thorac Surg. 2014 Mar;97(3):774-80. doi: 10.1016/j.athoracsur.2013.09.034. Epub 2013 Nov 22.
Author information: (1)Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum Berlin, Germany. Electronic address: zipfel@dhzb.de. (2)Department of Vascular Surgery, IRCCS, San Raffaele, Milan, Italy. (3)Department of Radiology, Hôpital de Rangueil, Toulouse, France. (4)Department of Vascular Surgery, Evangelismos Hospital, Athens, Greece. (5)Department of Vascular Surgery, Hospital Clínic, Barcelona, Spain. (6)Department of Vascular Surgery, Policlinico di Modena, Italy. (7)Department of Diagnostic and Interventional Radiology, Ospedale San Martino, Italy. (8)Department of Cardiothoracic and Vascular Surgery, Ospedale Le Scotte, Siena, Italy. (9)Department of Vascular Surgery, Hospital Germans Trias I Pujol, Barcelona, Spain. (10)Department of Vascular Surgery, ACO, San Filippo Neri, Rome, Italy. (11)Department of Vascular Surgery, IRCCS, Policlinico San Donato, Milan, Italy. (12)Department of Cardiovascular and Interventional Radiology, Allgemeines Krankenhaus, Vienna, Austria. (13)Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum Berlin, Germany. Comment in Ann Thorac Surg. 2014 Mar;97(3):781.

Abstract BACKGROUND: In blunt thoracic aortic injury, thoracic endovascular aortic repair (TEVAR) offers a less invasive alternative to open chest surgery. New reliable and accurate stent grafts have widened the endovascular treatment options. We report our experience with the Relay stent graft Bolton Medical, Sunrise, FL; Barcelona, Spain) for treatment of this injury. METHODS: Relay Endovascular Registry for Thoracic Disease (RESTORE) is a multicenter, prospective European registry, which enrolled patients treated with the Relay stent graft for thoracic aortic diseases from April 2005 to January 2009. Regular follow-up examinations were conducted for up to 24 months. This paper analyzes the cohort of patients treated for traumatic aortic injury. RESULTS: Forty adult trauma patients from 12 European centers underwent TEVAR. Mean age was 40 years and 34 patients were male. The proximal landing zone involved aortic arch zones 1 to 2 in 40% and zone 3 in 55% of procedures. Technical success was achieved in all cases. One (2.5%) patient suffered a rupture of the iliac artery. No patient developed procedure-related paraplegia or required conversion to open surgery. Follow-up imaging demonstrated complete exclusion of the traumatic tear and regression of the false aneurysms without endoleak or graft infolding. One late device-related complication was reported; penetration of the distal end of the stent graft treated by stent-graft extension. Thirty-day mortality was 2.5 % (n = 1), and late mortality 2.5% due to a secondary accident. Actuarial 2-year survival was 93.7%. CONCLUSIONS: Thoracic endovascular aortic repair with the Relay stent graft is a safe and effective treatment for patients with traumatic aortic injury.

15. Onorati F(1), D'Errigo P(2), Grossi C(3), Barbanti M(4), Ranucci M(5), Covello DR(6), Rosato S(2), Maraschini A(2), Santoro G(7), Tamburino C(4), Seccareccia F(2), Santini F(8), Menicanti L(5); OBSERVANT Research Group. Effect of severe left ventricular systolic dysfunction on hospital outcome after transcatheter aortic valve implantation or surgical aortic valve replacement: results from a propensity-matched population of the Italian OBSERVANT multicenter study. J Thorac Cardiovasc Surg. 2014 Feb;147(2):568-75. doi: 10.1016/j.jtcvs.2013.10.006. Epub 2013 Nov 19.
Author information: (1)Division of Cardiac Surgery, University of Verona Medical School, Verona, Italy. Electronic address: frankono@libero.it. (2)National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy. (3)Department of Cardiovascular Surgery, S. Croce e Carle Hospital, Cuneo, Italy. (4)Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy, and Excellence Through Newest Advances Foundation, Catania, Italy. (5)Department of Cardiothoracic and Vascular Anesthesia-Intensive Care Unit and Department of Cardiac Surgery, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy. (6)Department of Anesthesia and Intensive Care, IRCCS San Raffaele, Milan, Italy. (7)Division of Cardiology, Careggi Hospital, Florence, Italy. (8)Division of Cardiac Surgery, University Hospital San Martino, Genoa, Italy.

Abstract OBJECTIVE: Despite demonstration of the superior outcomes of transcatheter aortic valve implantation (TAVI) versus optimal medical therapy for severe left ventricular systolic dysfunction, studies comparing TAVI and surgical aortic valve replacement (AVR) in this high-risk group have been lacking. METHODS: We performed propensity matching for age, gender, baseline comorbidities, previous interventions, priority at hospital admission, frailty score, New York Heart Association class, EuroSCORE, and associated cardiac diseases. Next, the 30-day mortality and procedure-related morbidity of 162 patients (81 TAVI vs 81 AVR) with severe left ventricular systolic dysfunction (ejection fraction ≤ 35%) were analyzed at the Italian National Institute of Health. RESULTS: The 30-day mortality was comparable (P = .37) between the 2 groups. The incidence of periprocedural acute myocardial infarction (P = .55), low output state (P = .27), stroke (P = .36), and renal dysfunction (peak creatinine level, P = .57) was also similar between the 2 groups. TAVI resulted in significantly greater postprocedural permanent pacemaker implantation (P = .01) and AVR in more periprocedural transfusions (P < .01) despite a similar transfusion rate per patient (2.8 ± 3.7 for TAVI vs 4.4 ± 3.8 for AVR; P = .08). The postprocedural intensive care unit stay (median, 2 days after TAVI vs 3 days after AVR; P = .34), intermediate care unit stay (median, 0 days after both TAVI and AVR; P = .94), and hospitalization (median, 11 days after TAVI vs 14 days after AVR; P = .51) were comparable. CONCLUSIONS: In patients with severe left ventricular systolic dysfunction, both TAVI and AVR are valid treatment options, with comparable hospital mortality and periprocedural morbidity. Comparisons of the mid- to long-term outcomes are mandatory.

16. Ronco G(1), Dillner J(2), Elfström KM(2), Tunesi S(3), Snijders PJ(4), Arbyn M(5), Kitchener H(6), Segnan N(7), Gilham C(8), Giorgi-Rossi P(9), Berkhof J(4), Peto J(8), Meijer CJ(4); International HPV screening working group. . Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials. Lancet. 2014 Feb 8;383(9916):524-32. doi: 10.1016/S0140-6736(13)62218-7. Epub 2013 Nov 3
Collaborators: Cuzick J, Zappa M, Carozzi F, Confortini M, Dalla Palma P, Zorzi M, Del Mistro A, Gillio-Tos A, Naldoni C, Rijkaart D, van Kemenade F, Bulkmans N, Heideman D, Rozendaal R, Kenter G, Almonte M, Roberts C, Desai M, Sargent A, Ryd W, Naucler P. Author information: (1)Center for Cancer Epidemiology and Prevention, AO City of Health and Science, Turin, Italy. Electronic address: guglielmo.ronco@cpo.it. (2)Karolinska Institutet, Stockholm, Sweden. (3)Center for Cancer Epidemiology and Prevention, AO City of Health and Science, Turin, Italy. (4)VU University Medical Centre, Amsterdam, Netherlands. (5)Scientific Institute of Public Health, Brussels, Belgium. (6)Institute of Cancer Sciences, University of Manchester, Manchester, UK. (7)Center for Cancer Epidemiology and Prevention, AO City of Health and Science, Turin, Italy; International Agency for Research on Cancer (IARC), Lyon, France. (8)London School of Hygiene and Tropical Medicine, London, UK. (9)Azienda Sanitaria Locale, Reggio Emilia, Italy. Comment in Lancet. 2014 Apr 12;383(9925):1294-5. Lancet. 2014 Apr 12;383(9925):1295. Lancet. 2014 Apr 12;383(9925):1294. Lancet. 2014 Feb 8;383(9916):493-4.

Abstract BACKGROUND: In four randomised trials, human papillomavirus (HPV)-based screening for cervical cancer was compared with cytology-based cervical screening, and precursors of cancer were the endpoint in every trial. However, direct estimates are missing of the relative efficacy of HPV-based versus cytology-based screening for prevention of invasive cancer in women who undergo regular screening, of modifiers (eg, age) of this relative efficacy, and of the duration of protection. We did a follow-up study of the four randomised trials to investigate these outcomes. METHODS: 176,464 women aged 20-64 years were randomly assigned to HPV-based (experimental arm) or cytology-based (control arm) screening in Sweden (Swedescreen), the Netherlands (POBASCAM), England (ARTISTIC), and Italy (NTCC). We followed up these women for a median of 6•5 years (1,214,415 person-years) and identified 107 invasive cervical carcinomas by linkage with screening, pathology, and cancer registries, by masked review of histological specimens, or from reports. Cumulative and study-adjusted rate ratios (experimental vs control) were calculated for incidence of invasive cervical carcinoma. FINDINGS: The rate ratio for invasive cervical carcinoma among all women from recruitment to end of follow-up was 0•60 (95% CI 0•40-0•89), with no heterogeneity between studies (p=0•52). Detection of invasive cervical carcinoma was similar between screening methods during the first 2•5 years of follow-up (0•79, 0•46-1•36) but was significantly lower in the experimental arm thereafter (0•45, 0•25-0•81). In women with a negative screening test at entry, the rate ratio was 0•30 (0•15-0•60). The cumulative incidence of invasive cervical carcinoma in women with negative entry tests was 4•6 per 10(5) (1•1-12•1) and 8•7 per 10(5) (3•3-18•6) at 3•5 and 5•5 years, respectively, in the experimental arm, and 15•4 per 10(5) (7•9-27•0) and 36•0 per 10(5) (23•2-53•5), respectively, in the control arm. Rate ratios did not differ by cancer stage, but were lower for adenocarcinoma (0•31, 0•14-0•69) than for squamous-cell carcinoma (0•78, 0•49-1•25). The rate ratio was lowest in women aged 30-34 years (0•36, 0•14-0•94). INTERPRETATION: HPV-based screening provides 60-70% greater protection against invasive cervical carcinomas compared with cytology. Data of large-scale randomised trials support initiation of HPV-based screening from age 30 years and extension of screening intervals to at least 5 years. FUNDING: European Union, Belgian Foundation Against Cancer, KCE-Centre d'Expertise, IARC, The Netherlands Organisation for Health Research and Development, the Italian Ministry of Health.

Breve commento a cura di E. Crocetti
Lo studio di Ronco e collaboratori valuta congiuntamente i dati di quattro trial randomizzati condotti in Europa con l’obiettivo di confrontare l’efficacia, nei confronti del tumore cervicale invasivo, dello screening basato sul test HPV rispetto a quello citologico. Gli studi analizzati sono lo svedese Swedescreen, l’inglese ARTISTIC, l’olandese POBASCAN e l’italiano NTTC. Questi studi hanno utilizzato protocolli leggermente diversi riguardo l’età di inclusione, il test primario nel gruppo in studio (HPV+citologia tradizionale o in fase liquida) e nel gruppo di controllo (citologia tradizionale/fase liquida), i test nei passaggi ripetuti, l’intervallo fra test per le donne negative (3/5 anni) e riguardo l’effettuazione della colposcopia direttamente dopo un test HPV positivo o mediata da triage citologico. I risultati delle analisi pooled rappresentano una media pesata dell’efficacia di queste procedure. Per la definizione dei casi sono stati utilizzati i Registri tumori di popolazione regionali e nazionali, quelli di patologia oltre che archivi di referti cito-patologici a servizio degli screening.
Le donne che hanno effettuato l’HPV test hanno mostrato una importante riduzione di tumori cervicali invasivi (60-70%) rispetto a quelle che hanno effettuato la citologia. Il vantaggio del test HPV è presente anche nelle donne di 30-34 anni e si mantiene per un periodo che permette di pensare di estendere a 5 anni l’intervallo di screening. L’articolo ha suscitato dibattito ed è stato oggetto di un commento sulla stessa rivista nel quale si prevede come questi risultati contribuiranno a modificare, per tipo di test e intervalli, il futuro dello screening cervicale.

17. Colaci M(1), Giuggioli D, Vacchi C, Lumetti F, Iachetta F, Marcheselli L, Federico M, Ferri C. Breast cancer in systemic sclerosis: results of a cross-linkage of an Italian Rheumatologic Center and a population-based Cancer Registry and review of the literature. Autoimmun Rev. 2014 Feb;13(2):132-7. doi: 10.1016/j.autrev.2013.09.006. Epub 2013 Oct 6.
Author information: (1)Rheumatology Unit, University of Modena and Reggio Emilia, Medical School, Azienda Ospedaliero-Universitaria, Policlinico di Modena, Modena, Italy. Electronic address: michelecolaci@virgilio.it.

Abstract OBJECTIVE: Increased frequency of few types of cancer in systemic sclerosis (SSc) has been reported in the literature; in particular, breast carcinoma has been proposed as one of the most frequent malignancy in SSc patients, even though data are not univocal. The aim of the present study was to retrospectively evaluate the prevalence of breast cancer in our SSc series, compared with sex-/age-matched general population of the same geographical area, and the possible correlations with SSc features, including X-ray exposure for clinical investigations. A review of the world literature about this topic was also done. METHODS: Clinical records of 318 consecutive SSc patients, 31 M and 287 F, age 51.5±14.5 SD years, disease duration 10±6.5 SD years, referred to our Rheumatology Unit between January 2002 and December 2012 were evaluated. RESULTS: Twelve (3.8%) cases of breast cancer were recorded, including 11/287 females (3.8%) and 1/31 (3.2%) male patients. Considering the subgroup of 202 SSc patients resident in the Province of Modena compared with data of the local Tumor Registry, the incidence of breast cancer observed in our SSc series is significantly higher than expected (SIR 2.1; 95% interval of confidence: 1.13-3.90; p<0.01). On the whole, the comparison between SSc patients with cancer and those without did not show any significant differences with regard to SSc clinical features, including the X-ray exposure. Of note is the relatively shorter disease duration at the time of breast cancer detection (median 2.5years, range 1-21; disease duration of mean 10±6.5 SD years in the entire cohort). The review of the literature revealed that the observed incidence of breast cancer in our case series is comparable to the few studies reporting the highest percentages of this malignancy. CONCLUSIONS: A significant increase of breast cancer incidence compared to sex-age-matched general population from the same geographic area was observed. Moreover, a close temporal relationship between SSc and breast cancer onset was found, independently from clinical, serological, and instrumental features of SSc. The possible pathogenetic link between this systemic autoimmune disease and complicating breast cancer, as well as the results of previous studies, are discussed.

18. Onder G(1), Bonassi S, Abbatecola AM, Folino-Gallo P, Lapi F, Marchionni N, Pani L, Pecorelli S, Sancarlo D, Scuteri A, Trifirò G, Vitale C, Zuccaro SM, Bernabei R, Fini M; Geriatrics Working Group of the Italian Medicines Agency. High prevalence of poor quality drug prescribing in older individuals: a nationwide report from the Italian Medicines Agency (AIFA). J Gerontol A Biol Sci Med Sci. 2014 Apr;69(4):430-7. doi: 10.1093/gerona/glt118. Epub 2013 Aug 2.
Author information: (1)Centro Medicina dell'Invecchiamento, Dipartimento di Scienze Gerontologiche, Geriatriche e Fisiatriche, Università Cattolica del Sacro Cuore, Largo F. Vito 1, 00168 Roma, Italy. graziano_onder@rm.unicatt.it.

Abstract BACKGROUND: Poor quality of drug prescribing in older persons is often associated with increased drug-related adverse events, hospitalization, and mortality. The present study describes a set of prescribing quality indicators developed by the Geriatrics Working Group of the Italian Medicines Agency (AIFA) and estimates their prevalence in the entire elderly (≥ 65 years) population in Italy. METHODS: We performed a cross-sectional study using 2011 data from the OsMed (Osservatorio dei Medicinali) database, which comprises all prescribed drugs that are reimbursed by the Italian National Healthcare System. Yearly prevalence of drug prescribing quality indicators in the Italian older population (n = 12,301,537) was determined. RESULTS: Overall, 13 quality indicators addressing polypharmacy, adherence to treatment of chronic diseases, prescribing cascade, undertreatment, drug-drug interactions, and drugs to be avoided were identified. Polypharmacy was common, with more than 1.3 million individuals taking greater than or equal to 10 drugs (11.3% of the study population). The prevalence of low adherence and undertreatment was also elevated and increased with advancing age, with highest prevalence occurring in individuals aged 85 years and older. Prevalence was less than 3% for quality indicators assessing the prescribing cascade, drug-drug interactions, and drugs to be avoided. CONCLUSIONS: These results confirm the high frequency of suboptimal drug prescribing in older adults, using a database that covers the whole Italian population. In general, this descriptive study may help in prioritizing strategies aimed at improving the quality of prescribing in elderly population.

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