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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 settembre – 15 novembre 2013

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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 ("2013/09/01"[PDat] : "2013/11/25"[PDat])
1. Galzerano G, de Donato G, Setacci F, Sirignano P, Sauro L, Cappelli A, Setacci C. Acute limb ischemia in nonagenarians. J Cardiovasc Surg (Torino). 2013 Oct;54(5):625-31.
Department of Medical, Surgical and Neurosciences Unit of Vascular and Endovascular Surgery University of Siena, Siena, Italy. galzerano.giuseppe@gmail.com

Abstract AIM: Acute limb ischemia (ALI) is not infrequently associated with limb loss (10-30%) or death of the affected patient (15-30%). These results can be even worse in elderly population. The aim of this study is to quantify safety and efficacy of early revascularization in over 90 years old patients with acute limb ischemia. METHODS: This is a prospective registry lasting from January 2012 to January 2013. We include all consecutive over 90 years patients treated for ALI (N.=15). A careful preoperative Duplex scan (DS) were performed in each patient. All patients underwent surgery by Fogarty's embolectomy, and endovascular completion procedure if needed (N.=3). RESULTS: We performed 18 revascularizations (15 lower limbs, 3 upper limbs) in 15 patients (2 staged bilateral femoral, 1 simultaneous bilateral femoral). The mean follow-up was 124 days (4-365). Technical success was obtained in 16 cases (88.9%). At disharge mortality was 5.9% (1 case), and amputation rate was 6.2% (1 pt). The Kaplan-Meier curves at 1 year revealed an estimated freedom from death, amputation and re-occlusion of 76.5%, 88.2%, and 71.3%, respectively. CONCLUSION: The over 90 years old patient represent a challenging case for vascular surgeon. Vascular procedures involve high mortality rate but emergent revascularization by Fogarty Embolectomy in ALI is safe and effective even in older patient.

2. Bossone E, Pyeritz RE, O'Gara P, Harris KM, Braverman AC, Pape L, Russo MJ, Hughes GC, Tsai TT, Montgomery DG, Nienaber CA, Isselbacher EM, Eagle KA; International Registry of Acute Aortic Dissection (IRAD) Investigators. Acute aortic dissection in blacks: insights from the International Registry of Acute Aortic Dissection. Am J Med. 2013 Oct;126(10):909-15. doi: 10.1016/j.amjmed.2013.04.020. Epub 2013 Aug 13.
Heart Department, University Hospital, Salerno, Italy. Electronic address: ebossone@hotmail.com.

Abstract BACKGROUND: Few data exist on race-related differences in acute aortic dissection patients. METHODS: We evaluated black (n = 189, 14%) or white (n = 1165, 86%) patients (mean age 62.8 ± 15.3 years; 36.4% women) enrolled in 13 US centers participating in the International Registry of Acute Aortic Dissection. We excluded patients of other racial descent. RESULTS: Type B acute aortic dissection was more frequent in the black cohort (52.4% vs 39.3%, P = .001). Black patients were younger (mean age 54.6 ± 12.8 years vs 64.2 ± 15.2 years, P <.001) and more likely to have a history of cocaine abuse (12% vs 1.6%, P <.001), hypertension (89.7% vs 73.9%, P <.001), and diabetes (13.2% vs 6.4%, P = .001). Conversely, they were less likely to have bicuspid aortic valve (1.8% vs 5.8%, P = .029), iatrogenic dissection (0.5% vs 4.5%, P = .010), and prior aortic dissection repair (7.7% vs 12.8%, P = .047). Presenting features were similar except for more abdominal pain (44.6% vs 30.6%, P <.001) and left ventricular hypertrophy on echocardiogram (44.2% vs 20.1%, P <.001) in blacks. Management was similar. Hypotension/shock/tamponade was less common (7.6% vs 20.1%, P <.001), whereas acute kidney failure was more common (41.0% vs 21.7%, P <.001) in blacks. Mortality was similar in-hospital (14.3% vs 19.1%, P = .110, odds ratio 0.704, 95% confidence interval 0.457-1.085) and at 3 years postdischarge, as evaluated by Kaplan-Meier survival analysis (22.0% vs 14.3%, P = .224, SE = 0.062 and 0.018). CONCLUSIONS: Our study shows differences in type, etiology, and presentation of blacks and whites with acute aortic dissection, yet similar mortality for these cohorts.

3. Locatelli F, Crotta A, Ruggeri A, Eapen M, Wagner JE, Macmillan ML, Zecca M, Kurtzberg J, Bonfim C, Vora A, Díaz de Heredia C, Teague L, Stein J, O'Brien TA, Bittencourt H, Madureira A, Strahm B, Peters C, Niemeyer C, Gluckman E, Rocha V. Analysis of risk factors influencing outcomes after cord blood transplantation in children with juvenile myelomonocytic leukemia: a EUROCORD, EBMT, EWOG-MDS, CIBMTR study. Blood. 2013 Sep 19;122(12):2135-41. doi: 10.1182/blood-2013-03-491589. Epub 2013 Aug 7.
Department of Pediatric Hematology and Oncology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Ospedale Bambino Gesù, Università di Pavia, Rome, Italy;

Abstract We retrospectively analyzed 110 patients with juvenile myelomonocytic leukemia, given single-unit, unrelated donor umbilical cord blood transplantation. Median age at diagnosis and at transplantation was 1.4 years (age range, 0.1-6.4 years) and 2.2 years (age range, 0.5-7.4 years), respectively. Before transplantation, 88 patients received chemotherapy; splenectomy was performed in 24 patients. Monosomy of chromosome 7 was the most frequent cytogenetic abnormality, found in 24% of patients. All but 8 patients received myeloablative conditioning; cyclosporine plus steroids was the most common graft-versus-host disease prophylaxis. Sixteen percent of units were HLA-matched with the recipient, whereas 43% and 35% had either 1 or 2 to 3 HLA disparities, respectively. The median number of nucleated cells infused was 7.1 × 10(7)/kg (range, 1.7-27.6 × 10(7)/kg). With a median follow-up of 64 months (range, 14-174 months), the 5-year cumulative incidences of transplantation-related mortality and relapse were 22% and 33%, respectively. The 5-year disease-free survival rate was 44%. In multivariate analysis, factors predicting better disease-free survival were age younger than 1.4 years at diagnosis (hazard ratio [HR], 0.42; P = .005), 0 to 1 HLA disparities in the donor/recipient pair (HR, 0.4; P = .009), and karyotype other than monosomy 7 (HR, 0.5; P = .02). Umbilical cord blood transplantation may cure a relevant proportion of children with juvenile myelomonocytic leukemia. Because disease recurrence remains the major cause of treatment failure, strategies to reduce incidence of relapse are warranted.

4. Minicozzi P, Bella F, Toss A, Giacomin A, Fusco M, Zarcone M, Tumino R, Falcini F, Cesaraccio R, Candela G, La Rosa F, Federico M, Sant M. Relative and disease-free survival for breast cancer in relation to subtype: a population-based study. J Cancer Res Clin Oncol. 2013 Sep;139(9):1569-77. doi: 10.1007/s00432-013-1478-1. Epub 2013 Jul 28.
Analytical Epidemiology and Health Impact Unit, Department of Preventive and Predictive Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, 20133, Milan, Italy. pamela.minicozzi@istitutotumori.mi.it

Abstract PURPOSE: No population-based study has investigated breast cancer (BC) subtypes defined by including Ki67. The aim of this study was to evaluate the relative proportions of immunohistochemical subtypes and differences in relative and disease-free survival between subtypes, in relation to patient and other cancer characteristics in Italian BC patient. METHODS: Information on estrogen, progesterone, human epidermal growth factor (HER2), Ki67, and relapses was obtained for 3,381 cases, sampled randomly and anonymously from cases diagnosed in 2003-2005 in nine Italian cancer registries. Relative excess risks (RERs) of death and risks of relapse 5 years after diagnosis were estimated. RESULTS: Luminal A cancers were 42 % of the total, luminal B 27 %, luminal-HER2 14 %, triple-negative 11 %, and HER2-enriched 7 %. For non-metastatic (3,302) cases, 4 and 7 % developed locoregional and distant metastases, respectively. RERs of death and risks of relapse were significantly greater for all cancer subtypes than luminal A, particularly for triple-negative and HER2-enriched cancers, which were more frequent in women <40 years. CONCLUSIONS: Our population-based findings confirm that subtype is an independent prognostic factor for BC. Triple-negative and HER2-enriched subtypes would benefit from the development and wide application, respectively, of targeted treatments, which would also improve survival for younger patients.

5. D'Onofrio A, Salizzoni S, Agrifoglio M, Cota L, Luzi G, Tartara PM, Cresce GD, Aiello M, Savini C, Cassese M, Cerillo A, Punta G, Cioni M, Gabbieri D, Zanchettin C, Agostinelli A, Mazzaro E, Di Gregorio O, Gatti G, Faggian G, Filippini C, Rinaldi M, Gerosa G. Medium term outcomes of transapical aortic valve implantation: results from the Italian Registry of Trans-Apical Aortic Valve Implantation. Ann Thorac Surg. 2013 Sep;96(3):830-5; discussion 836. doi: 10.1016/j.athoracsur.2013.04.094. Epub 2013 Jul 16.
Division of Cardiac Surgery, University of Padova, Padova, Italy. adonofrio@hotmail.it

Abstract BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been proposed as a therapeutic option for high-risk or inoperable patients with severe symptomatic aortic valve stenosis. The aim of this multicenter study was to assess early and medium term outcomes of transapical aortic valve implantation (TA-TAVI). METHODS: From April 2008 through June 2012, a total of 774 patients were enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). Twenty-one centers were included in the I-TA registry. Outcomes were also analyzed according to the impact of the learning curve (first 50% cases versus second 50% cases of each center) and of the procedural volume (high-volume versus low-volume centers). RESULTS: Mean age was 81.0±6.7 years, mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I, EuroSCORE II, and The Society of Thoracic Surgeons risk score were 25.6%±16.3%, 9.4%±11.0%, and 10.6%±8.5%, respectively. Median follow-up was 12 months (range, 1 to 44). Thirty-day mortality was 9.9% (77 patients). Overall 1-, 2-, and 3-year survival was 81.7%±1.5%, 76.1%±1.9%, and 67.6%±3.2%, respectively. Thirty-day mortality of the first 50% patients of each center was higher when compared with the second half (p=0.04) but 3-year survival was not different (p=0.64). Conversely, 30-day mortality at low-volume centers versus high-volume centers was similar (p=0.22). At discharge, peak and mean transprosthetic gradients were 21.0±10.3 mm Hg and 10.2±4.1 mm Hg, respectively. These values remained stable 12 and 24 months after surgery. CONCLUSIONS: Transapical TAVI provides good results in terms of early and midterm clinical and hemodynamic outcomes. Thus it appears to be a safe and effective alternative treatment for patients who are inoperable or have high surgical risk.

6. Battino D, Tomson T, Bonizzoni E, Craig J, Lindhout D, Sabers A, Perucca E, Vajda F; EURAP Study Group. Seizure control and treatment changes in pregnancy: observations from the EURAP epilepsy pregnancy registry. Epilepsia. 2013 Sep;54(9):1621-7. doi: 10.1111/epi.12302. Epub 2013 Jul 12.
Epilepsy Center, Department of Neurophysiology and Experimental Epileptology, I.R.C.C.S. Neurological Institute "Carlo Besta" Foundation, Milan, Italy.

Abstract PURPOSE: To analyze seizure control, dose adjustments, and other changes of antiepileptic drug (AED) treatment during pregnancy in a large cohort of women with epilepsy entering pregnancy on monotherapy with carbamazepine, lamotrigine, phenobarbital, or valproate. METHODS: Seizure control and AED treatment were recorded prospectively in 3,806 pregnancies of 3,451 women with epilepsy taking part in European and International Registry of Antiepileptic Drugs and Pregnancy (EURAP), an international AED and pregnancy registry. KEY FINDINGS: Of all cases, 66.6% remained seizure-free throughout pregnancy. Generalized tonic-clonic seizures (GTCS) occurred in 15.2% of the pregnancies. Women with idiopathic generalized epilepsies were more likely to remain seizure-free (73.6%) than women with localization-related epilepsy (59.5%; p < 0.0001). Worsening in seizure control from the first to second or third trimesters occurred in 15.8% of pregnancies. The AED dose was increased during pregnancy in 26.0% and a second AED added to the initial monotherapy in 2.6% of all pregnancies. Seizures were more likely to occur in the first trimester in pregnancies with an increased drug load (35%; increased dose and/or addition of another AED) than in pregnancies without an increased drug load (15.3%) (p < 0.0001). Compared with other monotherapies, pregnancies exposed to lamotrigine were less likely to be seizure-free, 58.2% (p < 0.0001); had more GTCS, 21.1% (p < 0.0001); had a greater likelihood of deterioration in seizure control from first to second or third trimesters, 19.9% (p < 0.01), and were more likely to require an increase in drug load, 47.7% (p < 0.0001). The mean dose increases from the first to third trimesters were 26% for lamotrigine, 5% for carbamazepine, 11% for phenobarbital, and 6% for valproate. There were 21 cases of status epilepticus (10 convulsive): none with maternal mortality and only one with a subsequent stillbirth. SIGNIFICANCE: Although the majority of women remain seizure-free throughout pregnancy, our data suggest that a more proactive approach to adjusting the dose of all AEDs in pregnancy should be considered, in particular for those pregnancies with seizures occurring in the first trimester and those exposed to lamotrigine, to reduce the risk of deterioration in seizure control.

7. Zorzi M, Del Mistro A, Farruggio A, de'Bartolomeis L, Frayle-Salamanca H, Baboci L, Bertazzo A, Cocco P, Fedato C, Gennaro M, Marchi N, Penon MG, Cogo C, Ferro A. Use of a high-risk human papillomavirus DNA test as the primary test in a cervical cancer screening programme: a population-based cohort study. BJOG. 2013 Sep;120(10):1260-7; discussion 1267-8. doi: 10.1111/1471-0528.12272. Epub 2013 Jun 21.
Veneto Tumour Registry, Istituto Oncologico Veneto IRCCS, Padua, Italy. manuel.zorzi@ioveneto.it

Abstract OBJECTIVE: To present the results of the first 2 years of a human papillomavirus (HPV) test-based screening programme outside the research context. DESIGN: Population-based cohort study. SETTING: A cervical service screening programme in Italy. POPULATION: Women aged 25-64 years invited to screening from April 2009 to April 2011. METHODS: Eligible women were invited to undergo an HPV test: those with a negative HPV test went on to the next screening episode; those with a positive HPV went on to triage with a Pap smear. Women with positive cytology (i.e. positive for atypical squamous cells of undetermined significance or worse, ASC-US+) were referred to colposcopy, whereas those with negative cytology were referred to repeat HPV testing 1 year later. MAIN OUTCOME MEASURES: Participation rate, positivity at HPV and at triage, referral rate to colposcopy, positive predictive value for cervical intraepithelial neoplasia grade 2+ (CIN2+) at colposcopy, and detection rate for CIN2+. RESULTS: Participation increased compared with the previous Pap programme (60.6 versus 43.9%). The HPV positivity rate was 7.0; 39.6% of Pap smears were scored as positive, and therefore 2.8% of the women screened were referred for immediate colposcopy. The compliance of women who scored positive for HPV and negative for Pap for repeat HPV testing at 12 months was 78.6%, and the HPV positivity rate was 56.6%. The overall referral rate to colposcopy was 4.6%. The overall detection rate for CIN2+ was 4.5 versus 1.5% of the Pap programme (25-34 years, 8.2%; 35+ years, 3.6%). CONCLUSIONS: Compared with the traditional Pap test, the HPV programme recorded a higher response to invitation and an increased DR for CIN2+. The most critical aspects were the reading of cytology in women that were positive for HPV and the increased workload at colposcopy.

Breve commento a cura di E. Crocetti
Lo studio di Zorzi e alii ha valutato l’applicazione del test HPV come test primario nel primi due anni di attività di programma di screening cervicale organizzato in una ASL veneta. L’obiettivo è stato quello di valutare il test in una situazione di applicazione routinaria. I risultati sono stati molto positivi in termini di partecipazione, che è aumentata notevolmente rispetto ai livelli usuali del programma basato sul Pap test. E’ presumibile che sia stata l’attuale congiuntura economica a portare a privilegiare la gratuità del servizio più della tipologia del test. La positività HPV media è stata del 7% con una notevole riduzione all’aumentare dell’età. Rispetto ai risultati dei trial la proporzione di Pap positivi in donne HPV+ è risultata più elevata, probabilmente perché i citologi conoscevano lo stato HPV. La detection rate si conferma di tre volte più elevata rispetto al Pap test. La possibile sovra diagnosi e il carico di colposcopie sono i due principali aspetti negativi, rispetto ai quali gli Autori suggeriscono una serie di possibili strategie quali: il ridefinire il cut-off per la positività al test HPV, una formazione specifica per i citologi che esaminano i Pap di donne HPV+ (information bias), il prolungamento del tempo di richiamo per le donne HPV+/Pap- (nello studio 1 anno), o la selezione di pazienti di età più elevata (nello studio 25-64 anni). L’articolo è accompagnato da un commento di Pierre Martin-Hirsh, editor della rivista.

8. Maisano F, Franzen O, Baldus S, Schäfer U, Hausleiter J, Butter C, Ussia GP, Sievert H, Richardt G, Widder JD, Moccetti T, Schillinger W. Percutaneous mitral valve interventions in the real world: early and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe. J Am Coll Cardiol. 2013 Sep 17;62(12):1052-61. doi: 10.1016/j.jacc.2013.02.094. Epub 2013 Jun 7.
Scientific Institute San Raffaele, Milan, Italy. Electronic address: francesco.maisano@hsr.it. Comment in J Am Coll Cardiol. 2013 Sep 17;62(12):1062-4.

Abstract OBJECTIVES: The purpose of this article is to report early and mid-term outcomes of the ACCESS-EU study (ACCESS-Europe A Two-Phase Observational Study of the MitraClip System in Europe), a European prospective, multicenter, nonrandomized post-approval study of MitraClip therapy (Abbott Vascular, Inc., Santa Clara, California). BACKGROUND: MitraClip has been increasingly performed in Europe after approval; the ACCESS-EU registry provides a snapshot of the real-world clinical demographic data and outcomes. METHODS: A total of 567 patients with significant mitral valve regurgitation (MR) underwent MitraClip therapy at 14 European sites. Mean logistic European System for Cardiac Operative Risk Evaluation at baseline was 23.0 ± 18.3; 84.9% patients were in New York Heart Association functional class III or IV, and 52.7% of patients had an ejection fraction ≤40%. RESULTS: The MitraClip implant rate was 99.6%. A total of 19 patients (3.4%) died within 30 days after the MitraClip procedure. The Kaplan-Meier survival at 1 year was 81.8%. Intensive care unit and hospital length of stay was 2.5 ± 6.5 days and 7.7 ± 8.2 days, respectively. Single leaflet device attachment was reported in 27 patients (4.8%). There were no MitraClip device embolizations. Thirty-six subjects (6.3%) required mitral valve surgery within 12 months after the MitraClip implant procedure. There was improvement in the severity of MR at 12 months, compared with baseline (p < 0.0001), with 78.9% of patients free from MR, severity of >2+ at 12 months. At 12 months, 71.4% of patients had New York Heart Association functional class II or class I. Six-min-walk-test improved 59.5 ± 112.4 m, and Minnesota-living-with-heart-failure score improved 13.5 ± 20.5 points. CONCLUSIONS: In the real-world, post-approval experience in Europe, patients undergoing the MitraClip therapy are high-risk, elderly patients, mainly affected by functional MR. In this patient population, the MitraClip procedure is effective with low rates of hospital mortality and adverse events.

9. Georgoulopoulou E, Fini N, Vinceti M, Monelli M, Vacondio P, Bianconi G, Sola P, Nichelli P, Mandrioli J. The impact of clinical factors, riluzole and therapeutic interventions on ALS survival: a population based study in Modena, Italy. Amyotroph Lateral Scler Frontotemporal Degener. 2013 Sep;14(5-6):338-45. doi: 10.3109/21678421.2013.763281. Epub 2013 Feb 1.
Department of Neuroscience, S. Agostino-Estense Hospital and University of Modena and Reggio Emilia, Modena, Italy.

Abstract The prognostic role of riluzole, enteral nutrition (EN), non-invasive ventilation (NIV) and interdisciplinary care in ALS is still debated. A population based study has been performed focusing on ALS survival, with particular attention to prognostic factors and therapeutic intervention. All patients diagnosed with ALS between 2000 and 2009 and residing in Modena, Italy, have been registered. A centre for motor neuron disease (MND) has been active in our province since 2000, in addition to a prospective registry collecting all incident cases. One hundred and ninety-three incident cases have been collected during the 10 years of the study. Results demonstrated that median survival was 41 months (the overall three-year and five-year survival rates being 54.36% and 28.81%, respectively). Based on univariate analysis, factors related to survival were: age at diagnosis, gender, site of onset, phenotype, riluzole treatment and tracheostomy. In the Cox multivariable model, the factors independently related to a longer survival were age (p < 0.01), site of onset (p = 0.02) and riluzole treatment (p < 0.01), with a median gain in survival of 29 months (patients aged < 55 years compared with patients ≥ 55 years), 20 months (spinal versus bulbar onset), and 12 months (riluzole, yes vs. no), respectively. In conclusion, the study has confirmed the prognostic role of clinical features, but has surprisingly demonstrated that riluzole prolonged life significantly longer than NIV and EN. This observational study described the effects of ALS management in a setting that may approximate routine clinical practice more closely than randomized controlled trial (RCT); effects of uncontrolled potential confounders, however, cannot be excluded.

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