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Comparabilità e valutazione dei servizi sanitari

  • Nerina Agabiti1

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

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Ricerca bibliografica periodo dal 16 agosto al 31 ottobre 2012

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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 (“2012/08/16”[PDAT] : “2012/10/31”[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. Brignole M, Occhetta E, Bongiorni MG, Proclemer A, Favale S, Iacopino S, Calò L, Vado A, Buja G, Mascioli G, Quartieri F, Tritto M, Parravicini U, Castro A, Tomasi C, Villani GQ, D'Acri MG, Klersy C, Gasparini M; SAFE-ICD Study Investigators. Clinical evaluation of defibrillation testing in an unselected population of 2,120 consecutive patients undergoing first implantable cardioverter-defibrillator implant. J Am Coll Cardiol. 2012 Sep 11;60(11):981-7. doi: 10.1016/j.jacc.2012.05.014. Epub 2012 Aug 1.
Ospedali del Tigullio, Lavagna, Italy. mbrignole@asl4.liguria.it
Comment in J Am Coll Cardiol. 2012 Sep 11;60(11):988-9.

Abstract
OBJECTIVES: The purpose of this study is to assess the effectiveness of defibrillation testing (DT) in patients undergoing implantable cardioverter-defibrillator (ICD) insertion.
BACKGROUND: Although DT is considered a standard procedure during ICD implantation, its usefulness has not been definitively proven.
METHODS: The SAFE-ICD (Safety of Two Strategies of ICD Management at Implantation) study is a prospective observational study designed to evaluate the outcome of 2 strategies: performing defibrillation testing (DT+) versus not performing defibrillation testing (DT-) during de novo ICD implants. No deviation from the centers' current practice was introduced. In all, 2,120 consecutive patients (836 DT+ and 1,284 DT-) age ≥18 years were enrolled at 41 Italian centers from April 2008 to May 2009 and followed up for 24 months until June 2011. The primary endpoint was a composite of severe complications at ICD implant and sudden cardiac death or resuscitation at 2 years.
RESULTS: The primary endpoint occurred in 34 patients: 12 intraoperative complications (8 in DT+ group; 4 in DT- group) and 22 during follow-up (10 in DT+ group; 12 in DT- group). Overall, the estimated yearly incidence (95% confidence interval) was DT+ 1.15% (0.73 to 1.83) and DT- 0.68% (0.42 to 1.12). The difference between the 2 groups was negligible: 0.47% per year (-0.15 to 1.10). Mortality from any cause was similar at 2 years (adjusted hazard ratio: 0.97 [0.76 to 1.23], p = 0.80).
CONCLUSIONS: In this large cohort of new ICD implants, event rates were similar and extremely low in both groups. These data indicate a limited clinical relevance for DT testing, thus supporting a strategy of omitting DT during an ICD implant. (Safety of Two Strategies of ICD Management at Implantation [SAFE-ICD]; NCT00661037).

Breve commento a cura di Nerina Agabiti
Nello studio multicentrico italiano pubblicato da Brignole et al vengono presentati i risultati dello studio SAFE-ICD (Safety of twoStrategies of ICD Management and Implantation). Viene analizzata comparativamente la sicurezza di due strategie adottate durante l’applicazione del defibrillatore per la cardioversione (“implantablecardioverterdefibrillator”). La procedura oggetto di studio è il “test di defibrillazione” (“defibrillationtesting”). Un totale di 2120individui (età 18+ anni) sono stati arruolati consecutivamente in 41 centri italiani nel 2008-09 e sono stati seguiti per un periodo di follow up di 24 mesi fino al 2011. La frequenza del “test di defibrillazione” durante l’esecuzione dell’impianto varia molto tar centri. In totale 836 pazienti (39%) hanno avuto la procedura di “test di defibrillazione” durante l’inserzione del defibrllatore, mentre 1284 (61%) non l’hanno avuta. L’esito principale è un “endpoint” composito che include complicanze gravi e morte cardiaca improvvisa o manovre di rianimazione entro 2 anni. L’esito in studio è stato registrato in 34 pazienti con una stima di incidenza annuale di 1.15% nei pazienti con procedura di test effettuata e 0.68% in coloro che non l’hanno fatta. Anche la mortalità a 2 anni è simile tra i due gruppi a confronto. L’ampia raccolta di dati clinici a livello nazionale e la rigorosità della metodologia supportano le conclusioni degli Autori riguardo ad una imitata rilevanza clinica del test di defibrillazione durante l’impianto del defibrillatore cardiaco.

2. De Rango P, Lenti M, Simonte G, Cieri E, Giordano G, Caso V, Isernia G, Cao P. No benefit from carotid intervention in fatal stroke prevention for >80-year-old patients. Eur J Vasc Endovasc Surg. 2012 Sep;44(3):252-9. doi: 10.1016/j.ejvs.2012.06.006. Epub 2012 Jul 21.
Division of Vascular and Endovascular Surgery, Hospital S.M. Misericordia, Loc. S. Andrea delle Fratte, 06134 Perugia, Italy. plderango@gmail.com

Abstract Comment in Eur J Vasc Endovasc Surg. 2012 Sep;44(3):260.
BACKGROUND: Invasive management of patients ≥80 years of age with carotid stenosis may be questionable. The higher likelihood of stroke needs to be balanced with the increased perioperative risk and the reduced life expectancy of this ageing population. The purpose of this study was to evaluate the clinical relevance of carotid stenosis revascularisation in octogenarians.
METHODS: All patients ≥80 years of age who received carotid revascularisation in 2001-2010 were reviewed for perioperative and 5-year outcomes. The experience was comprehensive of carotid endarterectomy (CEA) and carotid stenting (CAS) performed during the training frame when age was not a contraindication for this procedure. Mortality rates were compared to those of octogenarians of the same geographical territory according to all-cause and stroke-related mortality national statistics datasets.
RESULTS: A total of 348 procedures performed in ≥80-year-old patients (272 males) were reviewed: 162 (46.6%) were by CAS and 169 (48.6%) were for symptomatic disease. Perioperative stroke/death rate was 5.5% and was non-significantly higher for symptomatic disease (7.1% vs. 3.9% asymptomatic; p = 0.24), after CAS (6.2% vs. 4.8% CEA; p = 0.64) and in females (6.6% vs. 5.1% males; p = 0.57). At median follow-up of 36.18 months, 95 deaths and 21 new ischaemic strokes (12 fatal) occurred with 5-year Kaplan-Meier freedom from stroke of 84.8% (78.7%, symptomatic vs. 90.3% asymptomatic; p = 0.003). According to national datasets, in 80-85-year-old resident population 5-year mortality was 29.9% (23.4% females, 40.6% males) and ischaemic stroke-related mortality was 14.9% (16.8% females, 13.0% males). Corresponding figures from treated population showed a 5-year mortality of 49.4%, higher in males (39.5% females, 52.5% males) and ischaemic stroke-related mortality of 20.2%, higher in females (40.0% females, 15.6% males). Comparing data from the study population with residents' figures, ischaemic stroke-related mortality hazard was significantly higher in the study females: odds ratio (OR) 3.2, 95% confidence interval (CI) 1.16-9.17; p = 0.029 (for males: OR 0.97, 95%CI 0.89-1.10; p = 0.99).
CONCLUSIONS: Despite perioperative stroke/death risks being lower compared with CAS, the benefit of surgical carotid revascularisation in old patients remains controversial due to limited life expectancy and high fatality of stroke in this ageing population. Invasive treatment of carotid stenosis may not be warranted in most patients ≥80 years of age with carotid stenosis, especially when female and asymptomatic.

Breve commento a cura di Nerina Agabiti
Negli ultraottantenni non è ancora ben chiaro il beneficio ottenibile dalle procedure invasive per il trattamento della stenosi carotidea . Il rischio di ictus cerebrale legato alla stenosi carotida deve infatti essere bilanciato con gli elevati rischi perioperatori e con la poca speranza di vita all’età di oltre 80 anni. Lo studio, condotto in tre centri clinici italiani, ha coinvolto 348 pazienti di 80+ anni con intervento di rivascolarizzazione carotidea nel periodo 2001-2010. I pazienti (78% uomini) sono stati seguiti per un periodi di follow up di 5 anni. Le procedure in studio sono la endoarterectomia carotidea (53%) e lo stent carotideo (47%). Poco meno della metà dei casi erano sintomatici. Il rischio di ictus perioeratorio e di morte è pari a 5.5%, non diverso significativamente tra casi sintomatici e non, tra generi e tra le due tecniche a confronto. Nel periodo di follow up sono state registrate 95 morti e 21 nuovi eventi ischemici con una differenza significativa tra casi sintomatici (liberi da eventi: 79%) e non(liberi da venti 90.3%). Dai dati di popolazione a livello nazionale risulta che la mortalità a 5 anni è pari a 29.9% (23.4% donne, 40.6% uomini) mente la mortalità specifca per ictus è maggiore tra le donne (16.8% donne vs. 13.0% uomini). Nel presente studio la mortalità a 5 anni è risultata paria 49.4% (52.5% uomini, 39.5% donne) e, di nuovo, dati più sfavorevoli tra le donne per la mortalità a 5 anni specifica per ictus cerebrale ((40% donne, 16.6% uomini). Rispetto alla popolazione residente di riferimento, la mortalità specifica per ictus è statisticamente più alta tra le donne in studio (OR= 3.2), mentre non c’è differenza per gli uomini (=R=0.97). Gli Autori suggeriscono che i benefici dell’intervento chirurgico, nonostante il basso rischio di complicanze perioperatoriedi tale intervento rispetto allo stent carotideo , sono ancora dubbi data l’alto rischio di ictus e la alta probabilità di morte in questa categoria di età. La chirurgia carotidea per stenosi della carotide andrebbe sconsigliata oltre 80 anni di età, specialmente se donne e in caso di assenza di sintomi.

3. Freyrie A, Gargiulo M, Gallitto E, Faggioli GL, Testi G, Giovanetti F, Stella A. Abdominal aortic aneurysms with short proximal neck: comparison between standard endograft and open repair. J Cardiovasc Surg (Torino). 2012 Oct;53(5):617-23. Epub 2012 Mar 12.
Vascular Surgery, Policlinico S. Orsola-Malpighi, Alma Mater Studiorum, Bologna University, Bologna, Italy. antonio.freyrie@unibo.it

Abstract
AIM: Comparing the results of the treatment of abdominal aortic aneurysms (AAA) with infra-renal neck length ≤1 cm with open repair (OR) and with endovascular treatment (EVAR) with standard endograft.
METHODS: Patients treated from January 2005 to December 2009 for infra-renal AAA with neck length ≤1 cm, were prospectively included. The choice of treatment was made up on anatomical and clinical criteria. Cases treated with OR (G1) and EVAR (G2) were compared. Primary end-points were: peri-operative mortality/morbidity and re-interventions, renal function worsening at discharge, mortality and re-interventions during follow-up. Secondary end points were: procedure time, need and time of intensive unit care (IUC) hospitalization, need for blood transfusions and hospital days. The comparison between groups was estimated by the Long-rank test.
RESULTS: Eighty-two patients were treated (76 males and 6 females); the mean age was 71.4 years (range 56-86) and the mean AAA diameter was 6.2 cm. Forty-four patients were enrolled in G1 and 38 in G2. The two groups were clinically homogeneous, except for: age (G1CONCLUSION: These results show that EVAR with standard endograft is an effective and reliable option in AAA with neck length ≤1 cm in short and mid-term follow-up. Long-term follow-up results are needed.

4. Palmerini T, Biondi-Zoccai G, Reggiani LB, Sangiorgi D, Alessi L, De Servi S, Branzi A, Stone GW. Risk of stroke with coronary artery bypass graft surgery compared with percutaneous coronary intervention. J Am Coll Cardiol. 2012 Aug 28;60(9):798-805. doi: 10.1016/j.jacc.2011.10.912.
Istituto di Cardiologia, Policlinico S. Orsola, Bologna, Italy.

Abstract
OBJECTIVES: This study sought to determine whether coronary artery bypass graft (CABG) surgery is associated with an increased risk of stroke compared with percutaneous coronary intervention (PCI).
BACKGROUND: Some, but not all, randomized trials have reported increased rates of stroke with CABG compared with PCI. However, all these studies were powered insufficiently to examine differences in the risk of stroke reliably.
METHODS: We performed a meta-analysis of 19 trials in which 10,944 patients were randomized to CABG versus PCI. The primary end point was the 30-day rate of stroke. We also determined the rate of stroke at the midterm follow-up and investigated whether there was an interaction between revascularization type and the extent of coronary artery disease on the relative risk of stroke.
RESULTS: The 30-day rate of stroke was 1.20% after CABG compared with 0.34% after PCI (odds ratio: 2.94, 95% confidence interval: 1.69 to 5.09, p < 0.0001). Similar results were observed after a median follow-up of 12.1 months (1.83% vs. 0.99%, odds ratio: 1.67, 95% confidence interval: 1.09 to 2.56, p = 0.02). The extent of coronary artery disease (single vessel vs. multivessel vs. left main) did not affect the relative increase in the risk of stroke observed with CABG compared with PCI at either 30 days (p = 0.57 for interaction) or midterm follow-up (p = 0.08 for interaction). Similar results were observed when the outcomes in 33,980 patients from 27 observational studies were analyzed.
CONCLUSIONS: Coronary revascularization by CABG compared with PCI is associated with an increased risk of stroke at 30 days and at the mid-term follow-up.

5. Olivari Z, Stritoni P, Burelli C, Scalia D, Brocco S, Fedeli U, Avossa F, Ferlin D, Reimers B, Grassi G, Fontanelli A, Valfrè C. The impact of drug eluting stents availability on the treatment choice among medical therapy, percutaneous or surgical revascularisation and on 4-year clinical outcome in patients with coronary artery disease: a cohort study. BMJ Open. 2012 Oct 26;2(5). pii: e001926. doi: 10.1136/bmjopen-2012-001926. Print 2012.
Cardiovascular Department, Cà Foncello Hospital, Treviso, Italy.

Abstract
OBJECTIVE: To investigate the influence of the availability of drug eluting stents (DES) on treatment choice (TC) among medical therapy (MT), coronary by-pass surgery (CABG) or percutaneous coronary interventions (PCI) and the consequent clinical outcomes in patients hospitalised because of coronary artery disease (CAD).
DESIGN: Observational study comparing two cohorts hospitalised immediately before, and 3 years after DES availability.
SETTING: Thirteen hospitals with cardiology facilities.
PATIENTS: 2131 consecutive patients with at least one coronary stenosis >50% at coronary angiography (CA) after exclusion of those with acute myocardial infarction or previous CABG or associated relevant valvular disease.
MAIN OUTCOME MEASURES: Treatment choice after CA and 4-year clinical outcomes.
RESULTS: TC among MT (27% vs 29.2%), PCI (58.6% vs 55.5%) and CABG (14.5% vs 15.3%) was similar in the DES and bare metal stent (BMS) periods (p = 0.51). At least one DES was implanted in 57% of patients treated with PCI in 2005. After 4 years, no difference in mortality (13.8% vs 13.2%, p = 0.72), hospital admissions for myocardial infarction (6.6% vs 5.2%, p = 0.26), stroke (2.2% vs 1.7%, p = 0.49) and further revascularisations (22.3% vs 19.7%, p = 0.25) were observed in patients enrolled in the DES and BMS periods. Only in patients with Syntax score 23-32 a significant change of TC (p = 0.0002) occurred in the DES versus BMS period: MT in 17.4% vs 31%, PCI in 62.2% vs 35.8%, CABG in 20.3% vs 33.2%, with similar 4-year combined end-point of mortality, stroke, myocardial infarction and further revascularisations (45.3% vs 34.2%, p = 0.087).
CONCLUSIONS: Three years after DES availability, the TC in patients with CAD has not changed significantly as well as the 4-year incidence of death, myocardial infarction, stroke and further revascularisations. In subgroup with Syntax score 23-32, a significant increase of indications to PCI was observed in the DES period, without any improvement of the 4-year clinical outcome.

6. Bidoli E, Fratino L, Bruzzone S, Pappagallo M, De Paoli P, Tirelli U, Serraino D. Time trends of cancer mortality among elderly in Italy, 1970--2008: an observational study. BMC Cancer. 2012 Oct 2;12(1):443. [Epub ahead of print]
BACKGROUND: The aging of the Italian population will unavoidably lead to a growing number of persons diagnosed and living with cancer. A comprehensive description of the burden of cancer mortality among Italian elderly (65-84 years of age) in the last four decades has not been carried out yet. Cancer mortality rates were used to describe time trends between 1970-2008.
METHODS: Mortality counts, provided by the Italian National Institute of Statistics, were grouped according to data availability: in quinquennia from 1970-74 through 1995-99, and in 2000-03 and 2006-08 groups. Age-standardized rates (world population) were computed by calendar periods while annual percent changes (APCs) were computed for elderly and middle aged (35-64 years) people for the period 1995-2008.
RESULTS: The number of cancer deaths in elderly nearly doubled between 1970-74 (31,400 deaths/year in men, and 24,000 in women) and 2006-08 (63,000 deaths/year in men, and 42,000 in women). Overall cancer mortality rates peaked during the quinquennia 1985-89 and 1990-94 (about 1,500/100,000 in men and 680 in women) and declined thereafter. Throughout 1995-2008 cancer mortality rates decreased by -1.6%/year in men and -0.9%/year in women. These decreases were mainly driven by cancers of the stomach, bladder, prostate, and lung (APC = -3.3%, -2.7%, -2.5%, -2.2%, respectively) in men, and by cancers of the stomach, bladder, and breast (APC = -3.5%, -1.9%, -1.1%, respectively) in women. Conversely, increases in mortality rates between 1995 and 2008 were recorded for lung cancer (APC = +0.6%) in women, cutaneous melanoma (APC = +1.7%) in men, and pancreatic cancer (APC = +0.6% in men and +0.9% in women).
CONCLUSIONS: Overall favorable trends in cancer mortality were observed among Italian elderly between 1995 and 2008. Early diagnosis, improved efficacy of anti-cancer treatments and management of comorbidities are the most likely explanations of these positive observations. However, enduring preventive interventions against the most common risk factor (e.g. cigarette smoking), early diagnosis, and access to care should be reconsidered and extended to match the reductions of cancer mortality recorded in the elderly with those in the middle aged.
7. Mannino S, Villa M, Apolone G, Weiss NS, Groth N, Aquino I, Boldori L, Caramaschi F, Gattinoni A, Malchiodi G, Rothman KJ. Effectiveness of adjuvanted influenza vaccination in elderly subjects in northern Italy. Am J Epidemiol. 2012 Sep 15;176(6):527-33. Epub 2012 Aug 31.
Although vaccination against influenza is recommended for elderly and high-risk patients in many countries, efficacy in the elderly has been suboptimal. The MF59 adjuvanted trivalent inactivated vaccine (ATIV) was developed to increase the immune response of elderly subjects to influenza vaccination, but its effectiveness has not yet been well documented. This prospective, observational study evaluated the relative effectiveness of ATIV versus nonadjuvanted trivalent inactivated vaccine (TIV) in individuals at least 65 years of age in Lombardy, northern Italy. Hospitalizations for influenza or pneumonia (International Classification of Diseases, Ninth Revision, Clinical Modification, codes 480-487) during the 2006-2007, 2007-2008, and 2008-2009 influenza seasons were identified from administrative databases. Stratified and regression analyses, including the propensity score to adjust for confounding, as well as generalized estimating equations to account for repeated vaccination, were used. Overall, 107,661 records were evaluated, contributing 170,988 person-seasons of observation. Since ATIV is preferentially recommended for more frail individuals, subjects vaccinated with ATIV were older and had more functional impairment and comorbidities. In the primary analysis, risk of hospitalization for influenza or pneumonia was 25% lower for ATIV relative to TIV (relative risk = 0.75, 95% confidence interval: 0.57, 0.98). To the extent that there is residual bias, ATIV is likely to be even more protective than this result suggests.
8. Dentali F, Riva N, Crowther M, Turpie AG, Lip GY, Ageno W. Efficacy and safety of the novel oral anticoagulants in atrial fibrillation: a systematic review and meta-analysis of the literature. Circulation. 2012 Nov 13;126(20):2381-91. doi: 10.1161/CIRCULATIONAHA.112.115410. Epub 2012 Oct 15.
UO Medicina Interna, Ospedale di Circolo, Viale Borri 57, 21100 Varese, Italy. fdentali@libero.it.

Abstract
BACKGROUND: Novel oral anticoagulants (NOACs) have been proposed as alternatives to vitamin K antagonists for the prevention of stroke and systemic embolism in patients with atrial fibrillation. Individually, NOACs were at least noninferior to vitamin K antagonists, but a clear superiority in overall and vascular mortality was not consistently proven.
METHODS AND RESULTS: We performed a meta-analysis of phase II and phase III randomized, controlled trials comparing NOACs with vitamin K antagonists in patients with atrial fibrillation. The MEDLINE and EMBASE databases, supplemented with conference abstract books and www.clinicaltrials.gov, were searched up to the first week of July 2012 with no language restriction. Two reviewers performed independent article review and study quality assessment. Data on overall and cardiovascular mortality, stroke or systemic embolism, ischemic stroke, major and intracranial bleeding, and myocardial infarction were collected. NOACs were pooled to perform a comparison with vitamin K antagonists, calculating pooled relative risks (RRs) and associated 95% confidence intervals (CIs). We retrieved 12 studies (3 administering dabigatran, 4 administering rivaroxaban, 2 administering apixaban, and 3 administering edoxaban) enrolling a total of 54 875 patients. NOACs significantly reduced total mortality (5.61% versus 6.02%; RR, 0.89; 95% CI, 0.83-0.96), cardiovascular mortality (3.45% versus 3.65%; RR, 0.89; 95% CI, 0.82-0.98), and stroke/systemic embolism (2.40% versus 3.13%; RR, 0.77; 95% CI, 0.70-0.86). There was a trend toward reduced major bleeding (RR, 0.86; 95% CI, 0.72-1.02) with a significant reduction of intracranial hemorrhage (RR, 0.46; 95% CI, 0.39-0.56). No difference in myocardial infarction was observed.
CONCLUSIONS: NOACs are associated with an overall clinical benefit compared with vitamin K antagonists. Additional research is required to confirm these findings outside the context of randomized trials.

9. Valenti R, Migliorini A, Parodi G, Carrabba N, Vergara R, Dovellini EV, Antoniucci D. Clinical and angiographic outcomes of patients treated with everolimus-eluting stents or first-generation Paclitaxel-eluting stents for unprotected left main disease. J Am Coll Cardiol. 2012 Oct 2;60(14):1217-22. doi: 10.1016/j.jacc.2012.05.038.
Division of Cardiology, Careggi Hospital, Florence, Italy.

Abstract
OBJECTIVES: The goal of this study was to compare the outcomes of patients treated with everolimus-eluting stents (EES) with outcomes of patients treated with first-generation paclitaxel-eluting stents (PES) for unprotected left main disease (ULMD).
BACKGROUND: No data exist about the comparison of these 2 types of stents in ULMD.
METHODS: The primary endpoint of the study was a 1-year composite of cardiac death, nonfatal myocardial infarction, target vessel revascularization, and stroke (MACE). Secondary endpoints were 1-year target vessel failure (TVF) and 9-month angiographic in-segment restenosis >50%.
RESULTS: From 2004 to 2010, a total of 390 patients underwent ULMD percutaneous coronary intervention (224 received PES and 166 EES). The 1-year MACE rate was 21.9% in the PES group and 10.2% in the EES group (p = 0.002). TVF rate was 20.5% in the PES group and 7.8% in the EES group (p < 0.001). The in-segment restenosis rate was 5.2% in the EES group and 15.6% in the PES group (p = 0.002). EES and EuroSCORE were the only variables related to the risk of MACE. EES (odds ratio: 0.32; p = 0.007) was also independently related to the risk of restenosis.
CONCLUSIONS: EES implantation for ULMD is associated with a reduced incidence of 1-year MACE, TVF, and restenosis as compared with PES implantation.

10. Van Mieghem NM, Généreux P, van der Boon RM, Kodali S, Head S, Williams M, Daneault B, Kappetein AP, de Jaegere PP, Leon MB, Serruys PW. Transcatheter aortic valve replacement and vascular complications definitions. EuroIntervention. 2012 Sep 27. pii: 20120607-03. [Epub ahead of print]
Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.

Abstract Aims: Transcatheter aortic valve replacement (TAVR) requires large calibre catheters and is therefore associated with increased vascular complications. The aim of this study was to illustrate the impact of the different definitions of major vascular complications on their incidence and to underscore the importance of uniform reporting. Methods and results: We pooled dedicated databases of consecutive patients undergoing TAVR from two tertiary care facilities and looked for the incidence of major vascular complications using various previously reported definitions. The level of agreement (Kappa statistic) between the respective definitions and the Valve Academic Research Consortium (VARC) consensus definition of vascular complications was assessed. A total of 345 consecutive patients underwent transfemoral TAVR and were included in this analysis. A completely percutaneous access and closure technique was applied in 96% of cases. Arterial sheath size ranged between 18 and 24 Fr, the majority being 18 Fr (60%). Procedural success was reached in 94.5%. Depending on the definition used, major vascular complications occurred in 5.2-15.9% of patients. According to the VARC definitions, the rate of major and minor vascular complications was 9.0% and 9.6%, respectively. Major vascular complications according to VARC criteria demonstrated at least a substantial level of agreement with the SOURCE registry (κ 0.80), the UK registry (κ 0.82) the Italian registry (κ 0.72) and "FRANCE" registry (κ 0.70) definitions, compared to a moderate level of agreement with the definitions used in the German registry (κ 0.47) and the 18 Fr Safety and Efficacy study (κ 0.42). Minor complications according to VARC demonstrated a moderate agreement only with vascular complications using the German registry definition (κ 0.54). Conclusions: Non-uniformity in how vascular complications are defined precludes any reliable comparison between previously reported TAVR registries. The VARC consensus document offers standardised endpoint definitions and should be universally adopted to obtain better insights into global TAVR experience.

11. Masala S, Chiocchi M, Taglieri A, Bindi A, Nezzo M, De Vivo D, Simonetti G. Combined use of percutaneous cryoablation and vertebroplasty with 3D rotational angiograph in treatment of single vertebral metastasis: comparison with vertebroplasty. Neuroradiology. 2012 Sep 27. [Epub ahead of print]
Department of Diagnostic and Molecular Imaging, Interventional Radiology and Radiation Therapy, Fondazione Policlinico Tor Vergata, viale Oxford 81, 00133, Rome, Italy, salva.masala@tiscali.it.

Abstract
INTRODUCTION: This study aims to assess the effectiveness of combined procedure of cryoablation and vertebroplasty (CVT) for reduction of pain and improvement of the quality of life in patients with single painful metastatic vertebral fractures.
METHODS: We retrospectively analyzed data from 23 patients with single vertebral metastasis treated with combined procedure of CVT, compared with those obtained in 23 patients treated by vertebroplasty. Pain intensity was evaluated by a visual analog scale (VAS) score administered before and 1 day, 1 week, and 1, 3, and 6 months after procedure. Quality of life was evaluated by an Oswestry Disability Index (ODI) score administered before and at 3 and 6 months after procedure.
RESULTS: Procedural success was achieved in all patients without any complications. The VAS and ODI scores showed a reduction in both groups during follow-up (VAS score, p < 0.05 and p < 0.001, respectively; ODI score, p < 0.0001). No difference of the VAS and ODI scores were observed before treatment (p = 0.33 and 0.78, respectively). VAS score showed a difference at 1 week and 1, 3, and 6 months after treatment (p < 0.001). ODI score showed a difference at 3 and 6 months after treatment (p < 0.001).
CONCLUSION: Our findings suggested that combined procedure of CVT is safe and effective for pain relief in single metastatic vertebral fractures, especially when other standard palliative treatments have failed, and improves disability. Careful needle positioning and accurate fluoroscopic and CT guidance are mandatory for a complication-free treatment.

12. Biondi A, Grosso G, Mistretta A, Marventano S, Toscano C, Gruttadauria S, Basile F. Laparoscopic-Assisted Versus Open Surgery for Colorectal Cancer: Short- and Long-Term Outcomes Comparison. J Laparoendosc Adv Surg Tech A. 2012 Sep 24. [Epub ahead of print]
1 Section of General Surgery and Oncology, Department of General Surgery, University Medical School of Catania , Catania, Italy .

Abstract
Background: Despite the theoretical advantages of laparoscopic surgery, it is still not considered the standard treatment for colorectal cancer patients because of criticism concerning oncologic stability. This study aimed at examining the short- and long-term follow-up results of laparoscopic surgery versus open surgery for colorectal cancer and at investigating clinical outcomes, oncologic safety, and any potential advantages of laparoscopic colorectal cancer resection.
Subjects and Methods: We retrospectively analyzed a database containing the information about patients who underwent surgery for stage I-III colorectal cancer from January 2004 to January 2012 at our institution.
Results: The patients who underwent the laparoscopic-assisted procedure showed a significantly faster recovery than those who underwent open surgery, namely, less time to first passing flatus (P=.041), time of first bowel motion (P=.04), time to resume normal diet (P=.043), and time to walk independently (P=.031). Laparoscopic colorectal surgery caused less pain for patients, leading to lower need of analgesic (P=.002) and less hospital recovery time (P=.034), compared with patients who underwent open surgery. No differences were found in 3- and 5-year overall and disease-free survival rates.
Conclusions: Our results suggested that the laparoscopic approach was as safe as the open alternative. Laparoscopic-assisted surgery has been shown to be a favorable surgical option with better short-term outcomes and similar long-term oncological control compared with open resection.

13. Schwander B, Ravera S, Giuliani G, Nuijten M, Walzer S. Cost comparison of second-line treatment options for late stage non-small-cell lung cancer: cost analysis for Italy. Clinicoecon Outcomes Res. 2012;4:237-43. Epub 2012 Sep 3.
Assessment-in-Medicine (AiM) GmbH, Loerrach, Germany;

Abstract
BACKGROUND: Lung cancer is the leading cause of cancer deaths worldwide (1.38 million cancer deaths, 18.2% of the total) and of cancer morbidity (1.61 million new cases, 12.7% of all new cancers). Currently only three second-line non-small-cell lung cancer (NSCLC) pharmacotherapies are licensed in the European Union: the chemotherapies pemetrexed and docetaxel and the epidermal growth factor receptor tyrosine kinase inhibitor erlotinib. These therapy alternatives have shown a comparable efficacy (survival benefit). In the past, cost comparisons showed that erlotinib was less costly compared to docetaxel, which in turn is cheaper than pemetrexed. Nowadays erlotinib (and docetaxel) are still less expensive than pemetrexed; but docetaxel lost patent protection (basic compound patent) at the end of 2010, so docetaxel drug costs have decreased rapidly and the question remains whether erlotinib is still the least costly therapy alternative in second-line NSCLC.
MATERIAL AND METHODS: Italy was selected for base case analysis to compare the total therapy costs, estimated by combining country-specific drug costs, administration costs, and adverse event costs of erlotinib and generic docetaxel in second-line NSCLC therapy. Sensitivity analyses on central input parameters have been performed.
RESULTS: The total costs of treating one patient with erlotinib therapy of €5121 are lower than the docetaxel costs of €6699 for the Italian health care setting. Although the drug costs of erlotinib are higher than generic docetaxel (incremental €3770): the costs of intravenous chemotherapy administration (incremental -€4510), and the costs of adverse event therapy (incremental -€837) lead to higher total therapy costs for docetaxel compared to the epidermal growth factor receptor tyrosine kinase inhibitor therapy erlotinib.
CONCLUSION: The cost comparison findings for Italy show that erlotinib is still the less costly therapy alternative in second-line NSCLC. These results were robust to changes of central input parameters and robust to further potential price decreases for docetaxel.

14. Cutolo PP, Nosso G, Vitolo G, Brancato V, Capaldo B, Angrisani L Clinical efficacy of laparoscopic sleeve gastrectomy vs laparoscopic gastric bypass in obese type 2 diabetic patients: a retrospective comparison. Obes Surg. 2012 Oct;22(10):1535-9. doi: 10.1007/s11695-012-0657-5.
General and Laparoscopic Surgery Unit, S. Giovanni Bosco Hospital, Naples, Italy. pierpaolo@cutolo.it

Abstract
BACKGROUND: Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are performed in patients with obesity and type 2 diabetes mellitus (T2DM). The aim of this study is to evaluate retrospectively the clinical efficacy of RYGB and SG in two groups of obese T2DM patients.
METHODS: From the hospital database, we extracted the clinical records of 31 obese T2DM patients, of whom 15 (7 F/8 M) had undergone laparoscopic SG (LSG) and 16 (7 F/9 M) laparoscopic RYGB (LRYGB) in the period 2005-2008. The groups were comparable for age (range 33-59 years) and BMI (range 38-57 kg/m(2)). LRYGB alimentary limb was 150 cm, and biliopancreatic limb was 150 cm from the Treitz ligament. LSG vertical transection was calibrated on a 40-Fr orogastric bougie. Data were analysed at 6, 12 and 18-24 months with reference to weight loss and remission of comorbidities.
RESULTS: The reduction in body weight was comparable in the two groups. At 18-24 months the percent BMI reduction was 29 ± 8 and 33 ± 11 % in LSG and LRYGB, respectively. Percent excess weight loss was 53 ± 16 and 52 ± 19 % in LSG and LRYGB, respectively. Thirteen patients in LSG and 14 patients in LRYGB discontinued their hypoglycaemic medications. Five (55 %) patients in LSG and eight (89 %) in LRYGB discontinued antihypertensive drugs. Three out of five patients in LSG and one out of two patients in LRYGB withdrew lipid-lowering agents.
CONCLUSIONS: LSG and LRYGB are equally effective in terms of weight loss and remission of obesity-related comorbidities. Controlled long-term comparisons are needed to establish the optimal procedure in relation to patients' characteristics.

15. Vercellini P, Somigliana E, Consonni D, Frattaruolo MP, De Giorgi O, Fedele L. Surgical versus medical treatment for endometriosis-associated severe deep dyspareunia: I. Effect on pain during intercourse and patient satisfaction. Hum Reprod. 2012 Aug 27. [Epub ahead of print]
From Clinica Ostetrica e Ginecologica, Istituto 'Luigi Mangiagalli', Università Statale di Milano, 20122 Milan, Italy.

Abstract
STUDY QUESTION: Does surgical or medical treatment for endometriosis-associated severe deep dyspareunia achieve better results in terms of patients' satisfaction (main study outcome), variation of coital pain and frequency of intercourse?
SUMMARY ANSWER: Surgery and progestin therapy were equally effective in the treatment of deep dyspareunia in women with rectovaginal endometriosis, whereas medical therapy performed significantly better than excisional treatment in those without deeply infiltrating lesions.
WHAT IS KNOWN AND WHAT THIS PAPER ADDS: Conservative surgery and hormonal therapies have been used independently for endometriosis-associated deep dyspareunia with inconsistent results. This study reports a direct comparison between the two treatment options in women with severe pain during intercourse.
DESIGN: Patient preference, parallel cohort study with a 12-month follow-up. The effect of conservative surgery at laparoscopy was compared with treatment with a low-dose of norethisterone acetate per os (2.5 mg/day) in women with persistent/recurrent severe deep dyspareunia after first-line surgery.
PARTICIPANTS AND SETTING: A total of 51 patients chose repeat surgery and 103 progestin treatment. Patient satisfaction was graded according to a five-category scale. Variations in pain during intercourse were measured by means of a 100-mm visual analogue scale.
MAIN RESULTS AND THE ROLE OF CHANCE: In the surgery group, a marked and rapid short-term dyspareunia score reduction was observed, followed by partial recurrence of pain. The pain relief effect of the progestin was more gradual, but progressive throughout the study period. At a 12-month follow-up, the frequency of intercourse per month (mean ± SD) was 4.6 ± 1.8 in the surgery group and 5.3 ± 1.5 in the norethisterone acetate group (P = 0.02). A total of 22/51 (43%) women were satisfied in the surgery group compared with 61/103 (59%) in the progestin group [adjusted odds ratios (OR), 0.36; 95% confidence interval (CI), 0.16-0.82; P = 0.015]. Corresponding figures in women with and without rectovaginal endometriotic lesions were, respectively, 13/24 (54%) versus 18/35 (51%; adjusted OR, 0.77; 95% CI, 0.22-2.67; P = 0.68), and 9/27 (33%) versus 43/68 (63%; adjusted OR, 0.23; 95% CI, 0.07-0.76, P = 0.02).
BIAS, CONFOUNDING, AND OTHER REASONS FOR CAUTION: Treatments were not randomly assigned, and distribution of participants as well as of dropouts between study arms was unbalanced. However, the possibility of choosing the treatment allowed assessment of the maximum potential effect size of the interventions.
GENERALIZABILITY TO OTHER POPULATIONS: Caucasian patients able to choose their treatment.
STUDY FUNDING/COMPETING INTEREST(S): This study was supported by a research grant from the University of Milan School of Medicine (PUR number 2009-ATE-0570). None of the authors have a conflict of interest.

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