rubrica

Comparabilità e valutazione dei servizi sanitari

  • Nerina Agabiti1

  • Marina Davoli1

  1. Dipartimento di epidemiologia del servizio sanitario regionale, Lazio
Nera Agabiti -

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Ricerca bibliografica periodo 02 aprile 2011 – 01 giugno 2011

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Database: Pubmed/MEDline
Stringa: (((“Quality Indicators, Health Care"[Mesh] OR "Quality Assurance, Health Care"[Mesh] OR "Outcome Assessment (Health Care)" [Mesh:NoExp] OR Outcome* [tiab] OR “quality indicators” [tiab], OR appropriateness [tiab] OR indicator* [TIAB] OR procedure [TIAB] OR efficacy[tiab] OR effectiveness[tiab]) AND ("hospitals"[MeSH] OR hospital[tiab] OR mortality[tw] OR patient* [tiab]) AND (italy[mesh] OR ital* [tiab] OR ita [la] OR ital* [ad]) AND ("2011/04/02"[PDAT] : "2011/06/01"[PDAT])) NOT ((animals [mesh] NOT humans [mesh]) OR "Genetics"[Mesh] OR "Neurophysiology"[Mesh] "Drug Therapy"[Mesh] OR "Naturopathy"[Mesh] OR "drug therapy "[Subheading] OR Editorial[ptyp] OR "Case Reports "[Publication Type] OR Letter[ptyp] OR Clinical Trial, Phase I[ptyp] OR Clinical Trial, Phase II[ptyp]))

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1. Di Carlo A, Lamassa M, Wellwood I, Bovis F, Baldereschi M, Nencini P, Poggesi A, Cramaro A, Pescini F, Lucente G, Wolfe CD, Inzitari D; European Registers of Stroke (EROS) Project. Stroke unit care in clinical practice: an observational study in the Florence center of the European Registers of Stroke (EROS) Project. Eur J Neurol. 2011 May;18(5):686-94. doi: 10.1111/j.1468-1331.2010.03207.x. Epub 2010 Sep 14.
Institute of Neurosciences, Italian National Research Council Department of Neurological and Psychiatric Sciences, University of Florence, Florence, Italy. dicarlo@in.cnr.it
Abstract
BACKGROUND: Randomized trials and meta-analyses indicate positive effects of stroke unit (SU) care on survival and dependency of patients with stroke. However, data on the advantages of SU in 'real-world' settings are limited. We prospectively assessed, in a large University Hospital, the effect of SU versus other conventional wards (OCW) care on all-cause mortality, death or dependency, death or institutionalization.
METHODS: In a prospective observational study in the European Registers of Stroke Project, patients hospitalized for first-in-a-lifetime stroke were evaluated for demographics, risk factors, clinical presentation, resource use, 3-month and 1-year survival, and functional outcome.
RESULTS: Overall, 355 patients (54.1% men, mean age 73.4 ± 14.5 years) were registered, 140 (39.4%) admitted to the SU, and 215 (60.6%) to OCW. OCW patients were older, whilst SU patients had more severe strokes according to NIHSS (P for trend = 0.025). SU patients were significantly more often treated by specialists in stroke medicine, stroke nurses, physiotherapists and speech therapists (all P < 0.001), psychologists (P = 0.025), dietitians (P < 0.001), and social workers (P = 0.003). MRI, carotid, and transcranial Doppler were significantly more often performed in SU patients (all P < 0.001). Intravenous fluids (P = 0.003) and intravenous anticoagulation (P < 0.001) were more often prescribed in SU. Controlling for case-mix, SU significantly reduced 1-year mortality (P = 0.020), death or dependency at 3 months (P = 0.006) and 1 year (P = 0.043), and death or institutionalization at 3 months (P = 0.001) and 1 year (P = 0.009).
CONCLUSIONS: We confirmed the benefits of SU care in a clinical setting. Further analyses should define the contribution of individual components of care to stroke outcome.
2. Cortese B, Bertoletti A, De Matteis S, Danzi GB, Kastrati A Drug-eluting stents perform better than bare metal stents in small coronary vessels: A meta-analysis of randomised and observational clinical studies with mid-term follow up. Int J Cardiol. 2011 May 12. [Epub ahead of print]
Interventional Cardiology, Ospedale Humanitas Gavazzeni, Bergamo, Italy.
Abstract
BACKGROUND: We tested drug-eluting stent (DES) and bare metal stent (BMS) performance in small coronary vessels by means of meta-analysis of all available clinical studies.
METHODS: The analysis included randomised controlled trials (RCT), subgroups of RCT and observational studies with a follow-up of at least six months comparing the use of DES and BMS during percutaneous interventions involving small coronary arteries (diameter<3mm). The primary endpoint was target vessel failure (TVF); the others were pooled and isolated major adverse cardiovascular events (MACE), stent thrombosis (ST), binary restenosis and late lumen loss at the longest available follow-up. The effect of treatment was evaluated in terms of odds ratios (OR) and 95% confidence intervals (95% CI) for binary variables, and mean difference (MD)±standard deviation (SD) for continuous variables. Fixed- or random-effect models were used depending on the statistical heterogeneity of studies. The analyses of major endpoints were stratified by study type, length of follow-up, and type of DES.
RESULTS: We pooled 12 studies involving 3182 patients. Trial heterogeneity was a minor issue. TVF (OR: 0.35; CI: 0.24-0.51), MACE (OR: 0.36; CI: 0.29-0.45), binary restenosis (OR: 0.15; CI: 0.12-0.20) and late lumen loss (MD: -0.46; SD: -0.55 to -0.38) all significantly improved with DES treatment; ST (OR: 0.63; CI: 0.34-1.17) was not statistically different between studies.
CONCLUSIONS: DES are superior to BMS in terms of their efficacy in managing small coronary arteries (diameter<3mm), and at least equivalent in terms of safety. The use of DES should be considered the treatment of choice in this setting.
3. Marrelli D, Pedrazzani C, Morgagni P, de Manzoni G, Pacelli F, Coniglio A, Marchet A, Saragoni L, Giacopuzzi S, Roviello F; on behalf of the Italian Research Group for Gastric Cancer (IRGGC). Changing clinical and pathological features of gastric cancer over time. Br J Surg. 2011 May 10. doi: 10.1002/bjs.7528. [Epub ahead of print]
Department of Human Pathology and Oncology, Section of Surgical Oncology, University of Siena, Siena, Italy. marrelli@unisi.it.
Abstract
BACKGROUND: The aim of the present multicentre observational study was to evaluate potential changes in clinical and pathological features of patients with gastric cancer (GC) treated in a 15-year interval.
METHODS: A centralized prospective database including clinical, surgical, pathological and follow-up data from 2822 patients who had resection of a primary GC was analysed. The analysis focused on three periods: 1991-1995 (period 1), 1996-2000 (period 2) and 2001-2005 (period 3). Surgical procedure, pathological classification and follow-up were standardized among centres.
RESULTS: The number of resections decreased from 1024 in period 1 to 955 and 843 in periods 2 and 3 respectively. More advanced stages and a smaller number of intestinal-type tumours of the distal third were observed over time. Five-year survival rates after R0 resection (2320 patients) did not change over time (overall: 56•6 and 51•2 per cent in periods 1 and 3; disease-free: 66•8 and 61•1 per cent respectively). Decreases in survival in more recent years were related particularly to more advanced stage, distal tumours and tumours in women. Multivariable analysis showed a lower probability of overall and disease-free survival in the most recent interval: hazard ratio 1•22 (95 per cent confidence interval 1•06 to 1•40) and 1•29 (1•06 to 1•58) respectively compared with period 1. Recurrent tumours were more frequently peritoneal rather than locoregional.
CONCLUSION: Overall and disease-free survival rates after R0 resection of GC were unchanged over time. Copyright © 2011 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

Breve commento a cura di Nerina Agabiti
Il tumore dello stomaco è ancora oggi una delle più frequenti cause di morte nel mondo, anche se le statistiche di mortalità segnalano un trend in decremento dell’incidenza. Ma come cambiano nel tempo le manifestazioni cliniche, i tipi istologici, le tecniche chirurgiche e la sopravvivenza? Contribuiscono a dare una risposta a queste domande gli Autori di questo lavoro pubblicato recentemente su Br J Surgery a nome del Gruppo Italiano di Ricerca per il Cancro Gastrico. Si tratta di uno studio multicentrico in cui 2822 pazienti con cancro dello stomaco sottoposti a chirurgia “potenzialmente curativa” sono stati arruolati in maniera prospettica lungo un periodo di 15 anni nei centri partecipanti al Registro, attivo dal 1990 con un database centralizzato e metodi standardizzati di raccolta dati. Sono stati confrontati 3 periodi: 1991-1995, 1996-2000, 2001-2005 (periodo 1,2 e 3 rispettivamente). La sopravvivenza cumulativa overall di periodo e la sopravvivenza in assenza di malattia (disease-free survival) sono i principali esiti. La mediana dei periodi di follow up è 48 mesi per il periodo 1, 78 mesi per il periodo 2 e 35 mesi per il periodo 3. I principali risultati sono: un decremento nel tempo di incidenza del cancro gastrico del terzo inferiore, un’alta percentuale di tumori di tipo diffuso (diffuse-type), una aumentata probabilità di sopravvivenza nei pazienti trattati con chirurgia radicale con un grande numero di linfonodi rimossi, un incremento delle forme diagnosticate in stadio clinico più avanzato ed una prognosi peggiore nel periodo più recente. La mortalità post-operatoria e la radicalità chirurgica è simile nei periodi. La sopravvivenza cumulativa a 5 anni è 54.7% e il disease-free servival è 64.7%, senza differenze significative tra periodi. I risultati di questo studio sono molto interessanti per l’epidemiologia del tumore gastrico, nonostante alcuni limiti metodologici. Se complessivamente il cancro gastrico è in declino, le forme più gravi all’esordio sono in aumento ed in particolare le forme di tipo diffuso del terzo inferiore dello stomaco. Questo potrebbe giustificare in parte il risultato di una sopravvivenza leggermente in declino negli anni recenti. Gli Autori suggeriscono l’esistenza di altri possibili ma ancora sconosciuti fattori biologici e clinici che si modificano nel tempo ed in grado di influenzare negativamente la prognosi. Se questa assunzione è giusta – affermano gli Autori – è ipotizzabile nel futuro uno scenario di cancro gastrico clinicamente più aggressivo del passato.

4. Ditto A, Martinelli F, Mattana F, Reato C, Solima E, Carcangiu M, Haeusler E, Mariani L, Raspagliesi F. Class III Nerve-sparing Radical Hysterectomy Versus Standard Class III Radical Hysterectomy: An Observational Study. Ann Surg Oncol. 2011 May 10. [Epub ahead of print]
Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy, antonino.ditto@istitutotumori.mi.it.
Abstract
BACKGROUND: The purpose of this observational study was to evaluate disease-free survival, overall survival, local recurrence rate, and morbidities in patients submitted to class III nerve-sparing radical hysterectomy (NSRH) compared with standard radical hysterectomy (RH) in cervical cancer (CC). This was a comparative study in the context of multimodal therapies.
MATERIALS AND METHODS: We investigated patients with CC admitted to the National Cancer Institute of Milan between January 4, 2001, and September 29, 2009, treated with NSRH. We compared patients operated with RH between March 20, 1980, and December 28, 1995. A total of 496 patients were enrolled. The median follow-up was 93 months (42 and 159 months for the NSRH and RH groups, respectively).
RESULTS: The overall number of relapses was 30 out of 185 and 60 out of 311 for NSRH and RH, respectively. Five-year disease-free survival estimate was 78.9% (95% confidence interval [CI] 72.0-85.7) in NSRH and 79.8% (95% CI 75.3-84.3) in RH (P = 0.519). Five-year overall survival estimate was 90.8% (95% CI 85.9-95.6) in NSRH and 84.1% (95% CI 8.0-88.3) in RH (P = 0.192). Rates of postoperative serious complications were 9.7% and 19.6% for NSRH and RH, respectively (P = 0.004). Positive pelvic lymph node and vagina status were significant (P < 0.01) independent predictors by multivariable analyses.
CONCLUSIONS: The oncologic results were comparable between NSRH and conventional class III RH in the context of two multimodal treatments. Bladder function and postoperative complications rate are improved by nerve-sparing technique. The nerve-sparing technique should be considered in all CC patients addressed to surgery because it improves functional outcome and preserves radicality without compromising overall survival.
5. Mosca M, Tani C, Aringer M, Bombardieri S, Boumpas D, Cervera R, Doria A, Jayne D, Khamashta MA, Kuhn A, Gordon C, Petri M, Schneider M, Shoenfeld Y, Smolen JS, Talarico R, Tincani A, Ward MM, Werth VP, Carmona L. Development of quality indicators to evaluate the monitoring of SLE patients in routine clinical practice. Autoimmun Rev. 2011 May;10(7):383-8. Epub 2011 Jan 9.
Rheumatology Unit, Department of Internal Medicine, University of Pisa, Italy. marta.mosca@int.med.unipi.it
Abstract
The assessment of systemic lupus erythematosus (SLE) patients in routine clinical practice is mainly based on the experience of the treating physician. This carries the risk of unwanted variability. Variability may have an impact on the quality of care offered to SLE patients, thereby affecting outcomes. Recommendations represent systematically developed statements to help practitioners in reducing variability. However, major difficulties arise in the application of recommendations into clinical practice. In this respect, the use of quality indicators may raise the awareness among rheumatologists regarding potential deficiencies in services and improve the quality of health care. The aim of this study was to develop a set of quality indicators (QI) for SLE by translating into QIs the recently developed EULAR Recommendations for monitoring SLE patients in routine clinical practice and observational studies. Eleven QIs have been developed referring to the use of validated activity and damage indices in routine clinical practice, general evaluation of drug toxicity, evaluation of comorbidities, eye evaluation, laboratory assessment, evaluation of the presence of chronic viral infections, documentation of vaccination and of antibody testing at baseline. A disease specific set of quality assessment tools should help physicians deliver high quality of care across populations. Routine updates will be needed.
6. Spada C, Hassan C, Munoz-Navas M, Neuhaus H, Deviere J, Fockens P, Coron E, Gay G, Toth E, Riccioni ME, Carretero C, Charton JP, Van Gossum A, Wientjes CA, Sacher-Huvelin S, Delvaux M, Nemeth A, Petruzziello L, Prieto C, Mayershofer R, Aminejab L, Dekker E, Galmiche JP, Frederic M, Johansson GW, Cesaro P, Costamagna G. Second-generation colon capsule endoscopy compared with colonoscopy. Gastrointest Endosc. 2011 May 19. [Epub ahead of print]
Digestive Endoscopy Unit, Catholic University, Rome, Italy.
Abstract
BACKGROUND: Colon capsule endoscopy (CCE) represents a noninvasive technology that allows visualization of the colon without requiring sedation and air insufflation. A second-generation colon capsule endoscopy system (PillCam Colon 2) (CCE-2) was developed to increase sensitivity for colorectal polyp detection compared with the first-generation system.
OBJECTIVE: To assess the feasibility, accuracy, and safety of CCE-2 in a head-to-head comparison with colonoscopy. DESIGN AND SETTING: Prospective, multicenter trial including 8 European sites. PATIENTS: This study involved 117 patients (mean age 60 years). Data from 109 patients were analyzed.
INTERVENTION: CCE-2 was prospectively compared with conventional colonoscopy as the criterion standard for the detection of colorectal polyps that are ≥6 mm or masses in a cohort of patients at average or increased risk of colorectal neoplasia. Colonoscopy was independently performed within 10 hours after capsule ingestion or on the next day.
MAIN OUTCOME MEASUREMENTS: CCE-2 sensitivity and specificity for detecting patients with polyps ≥6 mm and ≥10 mm were assessed. Capsule-positive but colonoscopy-negative cases were counted as false positive. Capsule excretion rate, level of bowel preparation, and rate of adverse events also were assessed.
RESULTS: Per-patient CCE-2 sensitivity for polyps ≥6 mm and ≥10 mm was 84% and 88%, with specificities of 64% and 95%, respectively. All 3 invasive carcinomas were detected by CCE-2. The capsule excretion rate was 88% within 10 hours. Overall colon cleanliness for CCE-2 was adequate in 81% of patients.
LIMITATIONS: Not unblinding the CCE-2 results at colonoscopy; heterogenous patient population; nonconsecutive patients.
CONCLUSION: In this European, multicenter study, CCE-2 appeared to have a high sensitivity for the detection of clinically relevant polypoid lesions, and it might be considered an adequate tool for colorectal imaging.
7. Landolina M, Gasparini M, Lunati M, Iacopino S, Boriani G, Bonanno C, Vado A, Proclemer A, Capucci A, Zucchiatti C, Valsecchi S, Ricci RP, Santini M; on behalf of the Cardiovascular Centers Participating in the ClinicalService Project. Long-Term Complications Related to Biventricular Defibrillator Implantation: Rate of Surgical Revisions and Impact on Survival: Insights From the Italian ClinicalService Database. Circulation. 2011 Jun 7;123(22):2526-2535. Epub 2011 May 16.
Dipartimento di Cardiologia, Fondazione IRCCS Policlinico San Matteo, P.le Golgi 2, 27100, Pavia, Italy. elettrofisiologia@smatteo.pv.it.
Abstract
Background- Long-term data on device-related untoward events in patients receiving defibrillators for resynchronization therapy (CRT-D) are lacking. We quantified the frequency of repeat invasive procedures and the nature of long-term complications in current clinical practice and examined possible predictors of device-related events and their association with long-term patient outcome.
Methods and Results- We analyzed data from 3253 patients who underwent de novo successful implantation of CRT-D and were followed up for a median of 18 months (25th to 75th percentiles: 9 to 30) in 117 Italian centers. Device-related events were reported in 416 patients, and, specifically, surgical interventions for system revision were described in 390 patients. Four years after the implantation procedure, 50% of patients underwent surgical revision for battery depletion and 14% for unanticipated events. For comparison, at 4 years battery depletion occurred in 10% and 13% of patients who received single- and dual-chamber defibrillators at the study centers, and unanticipated events were reported as 4% and 9%, respectively. In CRT-D, infections occurred at a rate of 1.0%/y, and the risk of infections increased after device replacement procedures (hazard ratio, 2.04; 95% confidence interval, 1.01 to 4.09; P=0.045). Left ventricular lead dislodgements were reported at a rate of 2.3%/y and were predicted by longer fluoroscopy time and higher pacing threshold on implantation. Device-related events were not associated with a worse clinical outcome; indeed, the risk of death was similar in patients with and without surgical revision (hazard ratio, 0.90; 95% confidence interval, 0.56 to 1.47; P=0.682).
Conclusions- In current clinical practice device-related events are more frequent in CRT-D than in single- or dual-chamber defibrillators, and are frequently managed by surgical intervention for system revision. However, a worse clinical outcome is not associated with these events. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT01007474.

Breve commento a cura di Nerina Agabiti
Non ci sono ancora molte evidenze sull’incidenza di eventi avversi correlati ai device nei pazienti ai quali è stato impiantato il defibrillatore per il trattamento di resincronizzazione cardiaca (CRT-D), terapia raccomandata nello scompenso cardiaco sintomatico di grado medio-grave. Lo studio di Landolina et al. Pubblicato su Circulation analizza i dati di 3253 pazienti arruolati consecutivamente in 117 centri italiani – nell’ambito del Clinical Service Project - con nuovo impianto di CTR-D e seguiti per un periodo medio di 18 mesi. Per evento avverso correlato al device si intende l’incidenza di situazioni i cui è necessario intervenire chirurgicamente per la revisione del sistema. Complessivamente nel 12.8% dei pazienti sono stati effettuati interventi chirurgici per la revisione del sistema. Circa l’8% dei pazienti ha subito un intervento di revisione chirurgica per deplezione della batteria e il 7% per unanticipated events richiedenti intervento che includono infezioni e disfunzione ventricolare sinistra rilevabile ecocardiograficamente. Il rischio di morte o trapianto cardiaco (4.0 per 100 paziente-anno) è simile tra chi ha avuto eventi avversi e chi no. Lo studio rappresenta un importante contributo sul tema anche a livello internazionale; esso è infatti uno dei primi studi che analizza gli eventi avversi di lungo periodo legati ai device nella resincronizzazione cardiaca, fornendo dati dalla reale pratica clinica relativi ad una notevole casistica applicando metodologie appropriate.

8. Caggegi A, Capodanno D, Capranzano P, Chisari A, Ministeri M, Mangiameli A, Ronsivalle G, Ricca G, Barrano G, Monaco S, Di Salvo ME, Tamburino C. Comparison of One-Year Outcomes of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Unprotected Left Main Coronary Artery Disease and Acute Coronary Syndromes (from the CUSTOMIZE Registry). Am J Cardiol. 2011 May 3. [Epub ahead of print]
Cardiovascular Department, Ferrarotto Hospital, University of Catania, Catania, Italy.
Abstract
Uncertainty surrounds the optimal revascularization strategy for patients with left main coronary artery disease presenting with acute coronary syndromes (ACSs), and adequately sized specific comparisons of percutaneous and surgical revascularization in this scenario are lacking. The aim of this study was to evaluate the incidence of 1-year major adverse cardiac events (MACEs) in patients with left main coronary artery disease and ACS treated with percutaneous coronary intervention (PCI) and drug-eluting stent implantation or coronary artery bypass grafting (CABG). A total of 583 patients were included. At 1 year, MACEs were significantly higher in patients treated with PCI (n = 222) compared to those treated with CABG (n = 361, 14.4% vs 5.3%, p <0.001), driven by a higher rate of target lesion revascularization (8.1% vs 1.7%, p = 0.001). This finding was consistent after statistical adjustment for MACEs (adjusted hazard ratio [HR] 2.7, 95% confidence interval [CI] 1.2 to 5.9, p = 0.01) and target lesion revascularization (adjusted HR 8.0, 95% CI 2.2 to 28.7, p = 0.001). No statistically significant differences between PCI and CABG were noted for death (adjusted HR 1.1, 95% CI 0.4 to 3.0, p = 0.81) and myocardial infarction (adjusted HR 4.8, 95% CI 0.3 to 68.6, p = 0.25). No interaction between clinical presentation (ST-segment elevation myocardial infarction or unstable angina/non-ST-segment elevation myocardial infarction) and treatment (PCI or CABG) was observed (p for interaction = 0.68). In conclusion, in patients with left main coronary artery disease and ACS, PCI is associated with similar safety compared to CABG but higher risk of MACEs driven by increased risk of repeat revascularization.
9. Benevolo G, Larocca A, Gentile M, Pregno P, Gay F, Botto B, Frairia C, Evangelista A, Morabito F, Boccadoro M, Vitolo U, Palumbo A. The efficacy and safety of bortezomib and dexamethasone as a maintenance therapy in patients with advanced multiple myeloma who are responsive to salvage bortezomib-containing regimens. Cancer. 2011 May 1;117(9):1884-90. doi: 10.1002/cncr.25743. Epub 2010 Nov 18.
Hematology 2, ASO S. Giovanni Battista, Turin, Italy. gbenevolo@molinette.piemonte.it
Abstract
BACKGROUND: Although treatment for multiple myeloma (MM) has considerably improved in the past decade, MM continues to be an incurable hematological malignancy that causes most patients to eventually relapse and die from their illness. Thus, the identification of effective salvage strategies remains a priority.
METHODS: In this trial, the authors evaluated the safety and efficacy of bortezomib and dexamethasone [V: on days 1 and 15 (1.3 mg/mq); D: on days 1-2 and 15-16, every 28-day cycle until progression (20 mg/d)] as maintenance therapy (MT) in patients with advanced MM who responded to salvage therapy that used a bortezomib-containing regimen.
RESULTS: Forty-nine MM patients were enrolled in this study between October of 2004 and April of 2008. All patients who were included in this study were responsive to a prior salvage therapy with bortezomib and had a measurable disease. The bortezomib and dexamethasone MT improved the quality of responses to complete remission in 4 patients and very good partial response in 3 patients. In addition, 10 patients experienced at least a 50% improvement in their symptoms. The median time to progression (TTP) was 16 months with a progression-free survival of 61% after 1 year. The overall response after 1 year was 76%, and the cumulative incidence of death due to disease progression, which was adjusted for competitive risk events, was 14%. Non-dose-limiting toxicities included neuropathy (predominantly grade 1), herpes zoster reactivation, pneumonia, and gastrointestinal affections (constipation and diarrhea). Three patients developed grade 2 neuropathy, which required a bortezomib dose reduction to 1.0 mg/mq. No grade 3 or 4 toxicities were recorded.
CONCLUSIONS: The use of bortezomib and dexamethasone as MT in advanced MM was effective and well tolerated. The twice-monthly bortezomib infusion appeared to reduce the incidence of grade 3 and 4 neuropathies in comparison to similar experiences in other settings.
10. De Nunzio C, Kramer G, Marberger M, Montironi R, Nelson W, Schröder F, Sciarra A, Tubaro A. The controversial relationship between benign prostatic hyperplasia and prostate cancer: the role of inflammation. Eur Urol. 2011 Jul;60(1):106-17. Epub 2011 Apr 9.
Department of Urology, Sant'Andrea Hospital, University "La Sapienza," Rome, Italy.
Abstract
CONTEXT: Prostate cancer (PCa) is the most common cancer in the adult male, and benign prostatic hyperplasia (BPH) represents the most frequent urologic diagnosis in elderly males. Recent data suggest that prostatic inflammation is involved in the pathogenesis and progression of both conditions.
OBJECTIVE: This review aims to evaluate the available evidence on the role of prostatic inflammation as a possible common denominator of BPH and PCa and to discuss its possible clinical implication for the management, prevention, and treatment of both diseases.
EVIDENCE ACQUISITION: The National Library of Medicine Database was searched for the following Patient population, Intervention, Comparison, Outcome (PICO) terms: male, inflammation, benign prostatic hyperplasia, prostate cancer, diagnosis, progression, prognosis, treatment, and prevention. Basic and clinical studies published in the past 10 yr were reviewed. Additional references were obtained from the reference list of full-text manuscripts.
EVIDENCE SYNTHESIS: The histologic signature of chronic inflammation is a common finding in benign and malignant prostate tissue. The inflammatory infiltrates are mainly represented by CD3(+) T lymphocytes (70-80%, mostly CD4), CD19 or CD20 B lymphocytes (10-15%), and macrophages (15%). Bacterial infections, urine reflux, dietary factors, hormones, and autoimmune response have been considered to cause inflammation in the prostate. From a pathophysiologic standpoint, tissue damage associated with inflammatory response and subsequent chronic tissue healing may result in the development of BPH nodules and proliferative inflammatory atrophy (PIA). The loss of glutathione S-transferase P1 (GSTP1) may be responsible in patients with genetic predisposition for the transition of PIA into high-grade intraepithelial neoplasia (HGPIN) and PCa. Although there is growing evidence of the association among inflammatory response, BPH, and PCa, we can only surmise on the immunologic mechanisms involved, and further research is required to better understand the role of prostatic inflammation in the initiation of BPH and PCa. There is not yet proof that targeting prostate inflammation with a pharmacologic agent results in a lower incidence and progression or regression of either BPH or PCa.
CONCLUSIONS: Evidence in the peer-reviewed literature suggested that chronic prostatic inflammation may be involved in the development and progression of chronic prostatic disease, such as BPH and PCa, although there is still no evidence of a causal relation. Inflammation should be considered a new domain in basic and clinical research in patients with BPH and PCa.
11. Fumagalli S, Valsecchi S, Boriani G, Gasparini M, Landolina M, Lunati M, Padeletti M, Tronconi F, Marchionni N, Padeletti L. Comparison of the Usefulness of Cardiac Resynchronization Therapy in Three Age-Groups (<65, 65-74 and ≥75 Years) (from the InSync/InSync ICD Italian Registry). Am J Cardiol. 2011 May 15;107(10):1510-6. Epub 2011 Mar 17.
Gerontology and Geriatric Medicine Unit, Critical Care Medicine and Surgery Department, University of Florence and AOU Careggi, Florence, Italy.
Abstract
Chronic heart failure is one of the most important geriatric syndromes, associated with disability, increased hospital admissions, and high mortality. The aim of this study was to evaluate the existence of age-related differences in clinical effectiveness and outcomes of cardiac resynchronization therapy (CRT), alone or in combination with an implantable cardioverter-defibrillator (CRT-D), in a large, real-world registry. A total of 1,787 patients admitted for CRT or CRT-D to the 117 centers participating in the InSync/InSync ICD Italian Registry from 1999 to 2005 were evaluated. Patients were divided into 3 age groups: <65 years (n = 571), 65 to 74 years (n = 740), and ≥75 years (n = 476). The left ventricular ejection fraction did not differ in the 3 groups (26 ± 8% vs 26 ± 7% vs 27 ± 8%, p = 0.123). Atrial fibrillation prevalence demonstrated an age-related increase. The use of recommended medical therapy for chronic heart failure decreased with age, as well as CRT-D implantation (p <0.001). The percentage of echocardiographic responders to CRT was similar in the 3 groups, and New York Heart Association class significantly improved independent of age. During the follow-up period (19 ± 13 months), all-cause mortality was higher in patients aged ≥75 years than in those aged <65 years (p = 0.005). In the whole population, mortality was associated with the nonresponder condition, the presence of atrial fibrillation and the lack of prescription of recommended medical therapy. In conclusion, CRT improved left ventricular performance and functional capacity independent of age. The proportion of the responder condition to CRT was the same in all groups. Pharmacologic undertreatment is an important issue in a "real-world" geriatric population.
12. Golfieri R, Cappelli A, Cucchetti A, Piscaglia F, Carpenzano M, Peri E, Ravaioli M, D'Errico-Grigioni A, Pinna AD, Bolondi L. Efficacy of selective transarterial chemoembolization in inducing tumor necrosis in small (<5 cm) hepatocellular carcinomas. Hepatology. 2011 May;53(5):1580-9. doi: 10.1002/hep.24246
University of Bologna, Bologna, Italy.
Abstract
Transarterial chemoembolization (TACE) is commonly used as a bridge therapy for patients awaiting liver transplantation (LT) and for downstaging patients initially not meeting the Milan criteria. The primary aim of this study was to analyze whether a difference exists between selective/superselective and lobar TACE in determining tumor necrosis by a pathological analysis of the whole lesion at the time of LT. The secondary aim was to investigate the relationship between the tumor size and the capacity of TACE to induce necrosis. Data were extracted from a prospective database of 67 consecutive patients who underwent LT for hepatocellular carcinoma and cirrhosis from 2003 to 2009 and were treated exclusively with TACE as a bridging (n = 53) or downstaging therapy (n = 14). We identified 122 nodules; 53.3% were treated with selective/superselective TACE. The mean histological necrosis level was 64.7%; complete tumor necrosis was obtained in 42.6% of the nodules. In comparison with lobar TACE, selective/superselective TACE led to significantly higher mean levels of necrosis (75.1% versus 52.8%, P = 0.002) and a higher rate of complete necrosis (53.8% versus 29.8%, P = 0.013). A significant direct relationship was observed between the tumor diameter and the mean tumor necrosis level (59.6% for lesions < 2 cm, 68.4% for lesions of 2.1-3 cm, and 76.2% for lesions > 3 cm). Histological necrosis was maximal for tumors > 3 cm: 91.8% after selective/superselective TACE and 66.5% after lobar procedures. Independent predictors of complete tumor necrosis were selective/superselective TACE (P = 0.049) and the treatment of single nodules (P = 0.008). Repeat sessions were more frequently needed for nodules treated with lobar TACE (31.6% versus 59.3%, P = 0.049). CONCLUSION: Selective/superselective TACE was more successful than lobar procedures in achieving complete histological necrosis, and TACE was more effective in 3- to 5-cm tumors than in smaller ones.
13. Asimakopoulos AD, Pereira Fraga CT, Annino F, Pasqualetti P, Calado AA, Mugnier C. Randomized comparison between laparoscopic and robot-assisted nerve-sparing radical prostatectomy. J Sex Med. 2011 May;8(5):1503-12. doi: 10.1111/j.1743-6109.2011.02215.x. Epub 2011 Feb 16.
Department of Surgery, University of Tor Vergata, Policlinico Tor Vergata, Rome, Italy. tasospao2003@yahoo.com
Abstract
INTRODUCTION: Lack of randomized controlled trials (RCTs) that compare pure laparoscopic radical prostatectomy (LRP) with robot-assisted laparoscopic radical prostatectomy (RALRP) is an important gap of the literature related to the surgical treatment of the clinically localized prostate cancer (PCa).
AIM: To provide the first prospective randomized comparison on the functional and oncological outcomes of LRP and RALRP for the treatment of the clinically localized PCa.
METHODS: Between 2007 and 2008, 128 consecutive male patients were randomized in two groups and treated by a single experienced surgeon with traditional LRP (Group I-64 patients) or RALRP (Group II-64 patients) in all cases with intent of bilateral intrafascial nerve sparing.
MAIN OUTCOME MEASURES: Primary end point was to compare the 12 months erectile function (EF) outcomes. Complication rates, continence outcomes, and oncological results were also compared. The sample size of our study was able, with an adequate power (1-beta>0.90), to recognize as significant large differences (above 0.30) between incidence proportions of considered outcomes.
RESULTS: No statistically significant differences were observed for operating time, estimated blood loss, transfusion rate, complications, rates of positive surgical margins, rates of biochemical recurrence, continence, and time to continence. However, the 12-month evaluation of capability for intercourse (with or without phosphodiesterase type 5 inhibitors) showed a clear and significant advantage of RALRP (32% vs. 77%, P < 0.0001). Time to capability for intercourse was significantly shorter for RALRP. Rates of return to baseline International Index of Erectile Function (IIEF-6) EF domain score questionnaires (questions 1-5 and 15) (25% vs. 58%) and to IIEF-6>17 (38% vs. 63%) were also significantly higher for RALRP (P = 0.0002 and P = 0.008, respectively).
CONCLUSIONS: Our study offers the first high-level evidence that RALRP provides significantly better EF recovery than LRP without hindering the oncologic radicality of the procedure. Larger RCTs are needed to confirm if a new gold-standard treatment in the field of RP has risen.
14. Repici A, Pagano N, Fumagalli U, Peracchia A, Narne S, Malesci A, Rosati R. Transoral treatment of Zenker diverticulum: flexible endoscopy versus endoscopic stapling. A retrospective comparison of outcomes. Dis Esophagus. 2011 May;24(4):235-9. doi: 10.1111/j.1442-2050.2010.01143.x. Epub 2010 Dec 10.
Gastroenterology Unit Minimally Invasive Surgery Unit, IRCCS Istituto Clinico Humanitas, Rozzano University of Milan School of Medecine, Endoscopic Surgery of The Upper Airways Unit, Policlinico Universitario, Padova, Italy.
Abstract
Transoral stapled diverticulo-esophagostomy (TSDE) has gained increased popularity in surgical treatment of Zenker diverticulum (ZD). One of the advantages of this approach is early rehabilitation with significant decrease in patient morbidity and time to resumption of oral intake as compared with open treatment. The section of the septum between the diverticulum and the esophagus with a flexible endoscopic (ES) approach has also been proposed since mid-90s as an alternative for treatment of ZD. Both these approaches are a minimally invasive approach to treat ZD. We compared the TSDE management of ZD versus the ES treatment in a retrospective consecutive series of patients who were referred to either the ES or surgical unit of our Institute. Fifty-eight consecutive patients underwent treatment for ZD either by TSDE or ES. The two techniques were evaluated for length of hospital stay, diverticulum size, resumption of oral intake, resolution of dysphagia, and complications. Clinical outcome was evaluated throughout a symptom score from 0 to 3, calculated before and after the procedure. The two groups were compared on the various parameters using a Mann-Whitney test. Twenty-eight patients underwent ES and 30 TSDE for ZD. In both groups, a significant decrease in postoperative versus preoperative dysphagia was reported. The average length of hospital stay wasn't significantly different in the two groups (3.38 days for TSDE vs. 2.42 days for ES). The overall complication rate was similar in the two groups. There were two cases in the ES group and three cases in the TDSE group that required an ES revision to take down a residual diverticular wall that produced a mild but persistent dysphagia. Minimally invasive treatment of ZD both with ES and with TSDE is a valuable option for this disease: both techniques are safe and effective, with similar outcome in terms of hospital stay, symptom reduction, and complication rate. Long-term results have to be evaluated.
15. Ortolani P, Solinas E, Guastaroba P, Casella G, Manari A, Piovaccari G, Balducelli M, Tondi S, Percoco G, Tarantino F, Passerini F, Rossi R, Vignali L, De Palma R, Grilli R, Marzocchi A. Long-term clinical outcomes after drug eluting stent implantation in women with de novo coronary lesions Results from the REAL (REgistro Regionale AngiopLastiche Emilia-Romagna) multicenter registry. Int J Cardiol. 2011 May 19;149(1):55-62. Epub 2010 Jan 8.
Istituto di Cardiologia, Università di Bologna, Policlinico S. Orsola-Malpighi, Italy.
Abstract
BACKGROUND: The long-term effectiveness of drug eluting stents (DESs) in a real-world setting of female patients is currently unclear.
METHODS AND RESULTS: We analyzed long-term follow-up (up to 3 years) data from all female patients with de novo lesions enrolled in a prospective web-based multicenter registry (REAL Registry; study period, July 2002-June 2006) including all 15 hospitals performing PCI in the Emilia-Romagna region of Italy. Among the 3549 women without ST elevation myocardial infarction, 2434 were treated with BMSs alone and 1115 with DESs alone. At 3 years, use of DESs was associated with a lower propensity score adjusted incidence of MACE [cardiac mortality, non-fatal myocardial infarction and target vessel revascularization (TVR); 19.5% vs. 24.4%; HR 0.75, p=0.006)] and TVR (11.6% vs. 15.6%; HR 0.68, p=0.004) compared with BMSs. No difference was apparent in terms of adjusted 3-year cardiac mortality or myocardial infarction. Nevertheless, after the first 6months of follow-up, a non significantly increased risk of myocardial infarction and stent thrombosis was found in the DES group.
CONCLUSIONS: In this real-world female registry, the use of DESs was associated with a 3-year reduction of TVR and MACE in comparison with the use of BMSs. However, the observed (non-significant) increment of late AMI makes performing larger studies to clarify the long-term safety of DESs mandatory.

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