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 gennaio al 31 marzo 2013

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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 (“2013/01/16”[PDat] : “2013/03/31”[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. Braido F, Brusselle G, Ingrassia E, Nicolini G, Price D, Roche N, Soriano JB, Worth H; LIAISON study group. InternationaL cross-sectIonAl and longItudinal assessment on aSthma cONtrol in European adult patients - the LIAISON study protocol. BMC Pulm Med. 2013 Mar 25;13:18. doi: 10.1186/1471-2466-13-18.
Chiesi Farmaceutici S,p,A, Via Palermo 26/A, Parma, 43122, Italy.

BACKGROUND: According to international guidelines, the goal of asthma management is to achieve and maintain control of the disease, which can be assessed using composite measures. Prospective studies are required to determine how these measures are associated with asthma outcomes and/or future risk. The 'InternationaL cross-sectIonAl and longItudinal assessment on aSthma cONtrol (LIAISON)' observational study has been designed to evaluate asthma control and its determinants, including components of asthma management. METHODS/DESIGN: The LIAISON study will be conducted in 12 European countries and comprises a cross-sectional phase and a 12-month prospective phase. Both phases will aim at assessing asthma control (six-item Asthma Control Questionnaire, ACQ), asthma-related quality of life (Mini Asthma Quality of Life Questionnaire, Mini-AQLQ), risk of non-adherence to treatment (four-item Morisky Medication Adherence Scale, MMAS-4), potential reasons for poor control, treatment strategies and associated healthcare costs.The cross-sectional phase will recruit > 8,000 adult patients diagnosed with asthma for at least 6 months and receiving the same asthma treatment in the 4 weeks before enrolment.The prospective phase will include all patients with uncontrolled/poorly controlled asthma at the initial visit to assess the proportion reaching control during follow-up and to examine predictors of future risk. Visits will take place after 3, 6 and 12 months. DISCUSSION: The LIAISON study will provide important information on the prevalence of asthma control and on the quality of life in a broad spectrum of real-life patient populations from different European countries and will also contribute to evaluate differences in management strategies and their impact on healthcare costs over 12 months of observation. TRIAL REGISTRATION: identifier, NCT01567280.

2. Kirchmayer U, Di Martino M, Agabiti N, Bauleo L, Fusco D, Belleudi V, Arcà M, Pinnarelli L, Perucci CA, Davoli M. Effect of evidence-based drug therapy on long-term outcomes in patients discharged after myocardial infarction: a nested case-control study in Italy(,) (.) Pharmacoepidemiol Drug Saf. 2013 Mar 26. doi: 10.1002/pds.3430. [Epub ahead of print]
Department of Epidemiology, Lazio Regional Health Service, Rome, Italy.

PURPOSE: There are some methodological concerns regarding results from observational studies about the effectiveness of evidence-based (EB) drug therapy in secondary prevention after myocardial infarction. The present study used a nested case-control approach to address these major methodological limitations. METHODS: A cohort of 6880 patients discharged from hospital after acute myocardial infarction (AMI) in 2006-2007 was enrolled and followed-up throughout 2009. Exposure was defined as adherence to each drug in terms of the proportion of days covered (cutoff ≥ 75%). Composite treatment groups, that is, groups with no EB therapy or therapy with one, two, three, or four EB drugs), were analyzed. Outcomes were overall mortality and reinfarction. Nested case-control studies were performed for both outcomes, matching four controls to every case (841 deaths, 778 reinfarctions) by gender, age, and individual follow-up. The association between exposure to EB drug therapy and outcomes was analyzed using conditional logistic regression, adjusting for revascularization procedures, comorbidities, duration of index admission, and use of the study drugs prior to admission. RESULTS: Mortality and reinfarction risk decreased with the use of an increasing number of EB drugs. Combinations of two or more EB drugs were associated with a significant protective effect (p < 0.001) versus no EB drugs (mortality: 4 EB drugs: ORadj  = 0.35; 95%CI: 0.21-0.59; reinfarction: 4 EB drugs: ORadj  = 0.23; 95%CI: 0.15-0.37). CONCLUSIONS: These findings of the beneficial effects of EB polytherapy on mortality and morbidity in a population-based setting using a nested case-control approach strengthen existing evidence from observational studies. Copyright © 2013 John Wiley & Sons, Ltd.

3. Paolicelli D, D'Onghia M, Pellegrini F, Direnzo V, Iaffaldano P, Lavolpe V, Trojano M. The impact of neutralizing antibodies on the risk of disease worsening in interferon β-treated relapsing multiple sclerosis: a 5 year post-marketing study. J Neurol. 2013 Feb 17. [Epub ahead of print]
Department of Neurosciences and Sense Organs, University of Bari Aldo Moro, Piazza Giulio Cesare 11, 70124, Bari, Italy.

The impact of neutralizing antibodies (NAbs) on interferon β (IFNβ) efficacy in MS patients is still an object of controversy. To evaluate the clinical response to IFNβ during NAb-positive (NAb+) and NAb-negative (NAb-) statuses on a large population of relapsing remitting (RR) MS patients were followed up to 5 years. Sera from 567 RR MS patients treated with IFNβ for 2-5 years were collected every 6-12 months and evaluated for NAb presence by a cytopathic effect assay. The relapse rate and expanded disability status scale (EDSS) score were assessed at baseline and every 6 months for each patient. A NAb+ status was defined after two consecutive positive titers of NAbs >/= 20 neutralizing units (NU)/mL. Multivariate models were used to analyze the relapse rate, the time to first relapse, the time to confirmed EDSS score 4 during NAb+ and NAb- statuses. A propensity score (PS) matching analysis was performed to assess the robustness of the multivariate models. Fourteen percent of patients became NAb+ during the follow-up. A significant increase of the relapse rate (IRR = 1.38; p = 0.0247) and decrease of the time to 1st relapse (IRR = 1.51; p = 0.0111) were found during NAb+ periods. The PS matching analysis, in a selected cohort of patients, demonstrated a negative trend of NAbs on the time to reach the milestone EDSS 4 (IRR = 2.94; p = 0.0879). This long-term post-marketing observational study further confirms that the occurrence of NAbs significantly affects the risk of disease worsening in IFNβ- treated RRMS.

4. Agabiti N, Stafoggia M, Davoli M, Fusco D, Barone AP, Perucci CA. Thirty-day complications after laparoscopic or open cholecystectomy: a population-based cohort study in Italy.
BMJ Open. 2013 Feb 13;3(2). pii: e001943. doi: 10.1136/bmjopen-2012-001943. Print 2013. Department of Epidemiology, Regional Health Service, Lazio Region, Rome, Italy.

OBJECTIVE: The objective of the study is to evaluate short-term complications after laparoscopic (LC) or open cholecystectomy (OC) in patients with gallstones by using linked hospital discharge data. DESIGN: Population-based cohort study. SETTING: Data were obtained from the Regional Hospital Discharge Registry Lazio Region in Central Italy (around 5 million inhabitants) in 2007-2008. PARTICIPANTS: All patients admitted to hospitals of Lazio with symptomatic gallstones (International Classification of disease, 9th Revision, Clinical Modification (ICD-9-CM)=574) who underwent LC (ICD-9-CM 51.23) or OC (ICD-9-CM 51.22). OUTCOME MEASURES: (1)'30-day surgical-related complications' defined as any complication of the biliary tract (including postoperative infection, haemorrhage or haematoma or seroma complicating a procedure, persistent postoperative fistula, perforation of bile duct and disruption of wound). (2) '30-day systemic complications' defined as any complications of other organs (including sepsis, infections from other organs, major cardiovascular events and selected adverse events). RESULTS: 13 651 patients were included; 86.1% had LC, 13.9% OC. 2.0% experienced surgical-related complications (SRC), 2.1% systemic complications (SC). The OR of complications after LC versus OC was 0.60 (p<0.001) for SRC and 0.52 (p<0.001) for SC. In relation to SRC, the advantage of LC was consistent across age categories, severity of gallstones and previous upper abdominal surgery, whereas there was no advantage among people with emergency admission (OR=0.94, p=0.764). For SC, no significant advantage of LC was seen among very old people (OR=0.99, p=0.975) and among those with previous upper abdominal surgery (OR=0.86, p=0.905). CONCLUSIONS: This large observational study confirms that LC is more effective than OC with respect to 30-day complications. Population-based linkage of administrative datasets can enlarge evidence of treatment benefits in clinical practice.

5. Forleo GB, De Martino G, Mantica M, Menardi E, Trevisi N, Faustino M, Muto C, Perna F, Santamaria M, Pandozi C, Pappalardo A, Mancusi C, Romano E, Della Bella P, Tondo C. Catheter ablation of atrial fibrillation guided by a 3D electroanatomical mapping system: a 2-year follow-up study from the Italian Registry On NavX Atrial Fibrillation ablation procedures (IRON-AF). J Interv Card Electrophysiol. 2013 Feb 10. [Epub ahead of print]
Division of Cardiology, Policlinico Universitario Tor Vergata, Viale Oxford, 81, 00133, Rome, Italy,

AIMS: Clinical trials have established that atrial fibrillation (AF) catheter ablation improves symptoms in appropriately selected patients. Confirmation of these results by long-term prospective observational studies is needed. This registry was created to describe the experience of 16 Italian centers with a large cohort of AF patients treated with catheter ablation guided by the NavX 3D mapping system. METHODS: From November 2006 to May 2008, 545 consecutive patients (age 60.4 ± 9.8, 67 % male) with paroxysmal (44 %), persistent (43 %), and long-standing persistent (13 %) AF referred for catheter ablation guided by the NavX system, were included in this registry. For this paper, follow-up was censored at 24 months; however, patients are being followed in the ongoing registry. RESULTS: Before the ablation, 80 % of patients failed to respond to at least one antiarrhythmic drug aimed at rhythm control. Pulmonary vein (PV) isolation guided by a circular mapping catheter was performed in 70 % of patients whereas non potential-guided PV encircling was performed in 30 % of patients. In 67 % of patients, additional left atrial (LA) substrate modification was performed. Image integration was performed in 9.2 % of patients. Considering a 3-month blanking period, after a single-ablation procedure, the patients had 1- and 2-year freedom from AF recurrence of 67.4 and 57.0 % (36.1 % off antiarrhythmic drugs), respectively. Cox regression analysis showed that AF recurrences during blanking (HR 2.1), and previous AF ablation (HR 3.3) were independent predictors of AF recurrences. Major procedure-related complications occurred in 53 patients (9.7 %). In 35 patients (6.7 %), a repeat procedure was performed at a median of 5 months after the initial procedure. CONCLUSIONS: This prospective, multicenter clinical experience provides significant insights into current ablation care of patients with AF. Despite favorable outcomes, real-world complication rates appear higher than previously recognized.

6. Gizzo S, Saccardi C, Patrelli TS, Di Gangi S, Breda E, Fagherazzi S, Noventa M, D'Antona D, Nardelli GB. Fertility rate and subsequent pregnancy outcomes after conservative surgical techniques in postpartum hemorrhage: 15 years of literature. Fertil Steril. 2013 Mar 14. pii: S0015-0282(13)00270-7. doi: 10.1016/j.fertnstert.2013.02.013. [Epub ahead of print]
Department of Woman and Child Health, University of Padua, Padua, Italy. Electronic address:

OBJECTIVE: To investigate the most appropriate surgical technique for optimizing hemostasis and preservation of subsequent fertility after postpartum hemorrhage (PPH). DESIGN: Systematic review of the literature. SETTING: Not applicable. PATIENT(S): None. INTERVENTION(S): Review of MEDLINE, EMBASE, ScienceDirect, and the Cochrane Library. MAIN OUTCOME MEASURE(S): Comparison of the effectiveness of conservative surgical techniques, separately or together, with respect to success rate (ability to stop bleeding and preserve the uterus), fertility rate (subsequent pregnancies or the return of regular menstrual cycles), complication rate of the procedure, and the outcomes of subsequent pregnancies in terms of type of delivery and eventual delivery complications. RESULT(S): Compressive sutures and vessel embolization may be considered life-saving procedures by achieving the best hemostatic efficacy. Data on restoration of menses and pregnancy rates after these procedures are limited by short-term follow-up and by the paucity of studies, especially for vascular ligation. CONCLUSION(S): Pelvic vessel embolization and compressive sutures are associated with high rates of restoration of regular menses and successive pregnancies, even if the former is burdened by an increased rate of placental disorders and fetal growth restriction and the latter by an increased risk of cesarean deliveries and PPH recurrence. Randomized trials would be desirable to define the best management of PPH.

7. Passoni NM, Abdollah F, Suardi N, Gallina A, Bianchi M, Tutolo M, Fossati N, Gandaglia G, Salonia A, Freschi M, Rigatti P, Montorsi F, Briganti A. Head-to-head comparison of lymph node density and number of positive lymph nodes in stratifying the outcome of patients with lymph node-positive prostate cancer submitted to radical prostatectomy and extended lymph node dissection. Urol Oncol. 2013 Mar 12. pii: S1078-1439(12)00355-9. doi: 10.1016/j.urolonc.2012.10.009. [Epub ahead of print]
Department of Urology, Vita-Salute University San Raffaele, Milan, Italy.

OBJECTIVE: The aim of this study was to compare the predictive ability of lymph node density (LND) and number of positive lymph nodes in patients with prostate cancer and lymph node invasion. MATERIALS AND METHODS: We included 568 patients with lymph node invasion treated with radical prostatectomy and extended pelvic lymph node dissection between January 1990 and July 2011 at a single center. The Kaplan-Meier method and multivariable Cox regression models tested the association between the number of positive lymph nodes or LND and cancer-specific survival (CSS). The predictive accuracy of a baseline model was assessed using Harrell's concordance index and then compared with that of a model including either the number of positive nodes or LND. RESULTS: The median number of positive lymph nodes was 2, whereas the median LND was 11.1%. At 5, 8, and 10 years, CSS rates were 92.5%, 83.9%, and 82.8%, respectively. At multivariable analyses, number of positive lymph nodes and LND, considered as continuous variables, were independent predictors of CSS (all P≤0.01). A 30% LND cutoff was found to be highly predictive of CSS (P = 0.004), and a cutoff of 2 positive nodes was confirmed to be a strong predictor of CSS (P = 0.02). The number of positive nodes and LND similarly, continuous or dichotomized, increased the accuracy for CSS predictions (0.68-0.69 vs. 0.61 of baseline model). LND cutoff of 30% increased the discrimination the most (0.69; +0.083). CONCLUSIONS: The number of positive lymph nodes and LND showed comparable discriminative power for long-term CSS predictions. A cutoff of 30% LND might be suggested for the selection of patients candidate for adjuvant systemic therapy, because it increased the model's discrimination the most.

8. Dorigo W, Pulli R, Fargion A, Pratesi G, Angiletta D, Aletto I, Alessi Innocenti A, Pratesi C. Comparison of Open and Endovascular Treatments of Post-carotid Endarterectomy Restenosis. Eur J Vasc Endovasc Surg. 2013 Feb 20. pii: S1078-5884(13)00073-7. doi: 10.1016/j.ejvs.2013.01.029. [Epub ahead of print]
Department of Vascular Surgery, University of Florence, Florence, Italy. Electronic address:

AIM OF THE STUDY: To compare early and long term results of open and endovascular treatment of post-carotid endarterectomy (CEA) restenosis in a single centre experience. METHODS: From January 2005 to December 2011, ninety-nine consecutive interventions for primary severe post-CEA restenosis were performed: in 41 cases (41%, Group 1) open repair was carried out, whereas the remaining 58 patients (59%, group 2) underwent an endovascular treatment. Data concerning these interventions were prospectively collected in a dedicated database containing main pre, intra and postoperative variables. Early results in terms of 30-day stroke and death rates were analysed and compared with χ(2) test. Follow-up results were analysed with Kaplan Meier curves and compared with log-rank test. RESULTS: Mean time from primary CEA was 75 months in group 1 and 42 months in group 2 (p = 0.002; 95% CI 12-52). There were no differences between the two groups in terms of demographic data, comorbidities, risk factors for atherosclerosis, preoperative clinical status or degree of stenosis on the operated side. In group 1 interventions consisted of redo-CEA in 37 patients and of carotid bypass in the remaining 4; all the patients in group 2 underwent stent placement with cerebral protection device. No perioperative deaths and ipsilateral neurological events occurred in both groups. One patient in group 1 suffered from a non-fatal acute myocardial infarction. Other six patients (14.5%) experienced transient cranial nerve injuries, with complete regression at 1-month follow-up; two patients had postoperative dysphagia due to neck haematoma, which was medically managed. Neither access-related nor systemic complications were recorded in group 2. Follow-up was available in 98% of the patients with a median duration of 24 months (range 3-72). There were no differences in terms of 4-year estimated survival and stroke-free survival, whereas patients in group 1 were more likely to develop severe (>80%) secondary restenosis (28.3% and 6.5%, respectively, p = 0.01, log rank 6.3) and to undergo secondary reintervention (22% and 11%, respectively p = 0.01, log rank 6). CONCLUSIONS: despite the selection limits and bias of this study, in our experience open and endovascular surgery provided similar perioperative results in the management of post-CEA restenosis. Long term outcomes are similar, too, despite a slight increase in secondary restenosis and recurrent reinterventions among open surgery patients, warranting further studies and analysis.

Breve commento a cura di Nerina Agabiti
Esiste ancora controversia sul rischio di stenosi successivo all’intervento di chirurgia carotidea in caso di stenosi carotidea su base aterosclerotica. Scopo di questo lavoro, frutto di una collaborazione tra tre centri di chirurgia vascolare italiana (Firenze, Roma, Bari), è stato confrontare l’efficacia di due tecniche: l’endoarterectomia carotidea (CEA)e lo stent carotideo (CAS). Lo studio è interessante perché ci sono ancora pochi studi osservazionali che confrontano direttamente le due procedure chirurgiche. Sono stati arruolati 2314 pazienti nel periodo dal 2005 al 2011. Il periodo di follow up medio è stato di 24 mesi. Non si è osservato nessun decesso né evento neurologico grave perioperatorio. Un paziente con CEA ha avuto un infarto del miocardio non fatale. 14% di pazienti con CEA hanno avuto danni ai nervi cranici ma i sintomi sono regrediti a un anno; due pazienti hanno avuto disfagia postoperatoria di grado lieve. Nessuna complicazione è stata registrata nel gruppo sottoposto a CEAS. Nessuna differenza tra le due procedure è stata riscontrata in termini di sopravvivenza a 4 anni e tempo-libero da ictus cerebrale. Tuttavia i pazienti sopposti a CEA avevano un maggiore rischio di sviluppare una nuova stenosi severa e di subire un nuovo intervento. Lo studio documenta l’efficacia - complessivamente equivalente - delle due tecniche, più evidente nel breve termine, mentre nel lungo termine lo stent sembra avere migliori risultati rispetto alla endoarterectomia tradizionale. Gli autori commentano i limiti dello studio e concludono sull’importanza di condurre nuovi studi prospettici che confrontino risultati delle due procedure tra popolazioni con lesioni arteriose simili.

9. Vitacca M, Vianello A; on behalf of the Scientific Group on Respiratory Intensive Care of the Italian Association of Hospital Pulmunologists.. Respiratory Outcomes Of Patients With Als: An Italian Nationwide Survey. Respir Care. 2013 Feb 19. [Epub ahead of print]
Divisione di Pneumologia Riabilitativa, Fondazione Salvatore Maugeri, IRCCS Lumezzane (Brescia), Italy.

BACKGROUND: Despite recommendations, respiratory therapies still remain partially underutilized in ALS patients and different habits are described among different countries. The objective of our study was to evaluate attitudes and practices in Amyotrophic Lateral Sclerosis (ALS) in our country, in comparison with therapeutic intervention for Neuromuscular Diseases (NMDs) other than ALS. METHODS: A questionnaire on management approaches for ALS and NMDs was mailed to 178 Pneumological Units (PUs). PUs were classified into high versus low volume referring centers according to the number of ALS/NMD patients followed in the last 5 years. RESULTS: 76 PUs (43%) responded after having an historical sample size of 1772 ALS patients and 1490 NMDs patients. Difficulty clearing respiratory secretions and disturbed sleep were the main reasons the patients with ALS were referred to PUs. Vital capacity in a sitting position and arterial blood gases were measured regularly, while respiratory muscle function and cough ability were routinely assessed in over 85% of the PUs, (mainly in high referring centers) and 94% of PUs had access to noninvasive ventilation (NIV). Treatment approach in NMDs was similar to that of ALS, except for administration of tracheostomy, which was less frequently performed in NMDs. A multidisciplinary team approach to care was employed in approximately 90% of PUs. Approximately a third of PUs accessed palliative care services. CONCLUSIONS: Combined pulmonary function evaluation, long-term NIV and assisted coughing have become usual practices for ALS patients. Care habits for ALS do not significantly differ from approach to other NMDs.

10. Mogorovich A, Nilsson AE, Tyritzis SI, Carlsson S, Jonsson M, Haendler L, Nyberg T, Steineck G, Wiklund NP. Radical Prostatectomy, Sparing of the Seminal Vesicles, and Painful Orgasm. J Sex Med. 2013 Feb 19. doi: 10.1111/jsm.12086. [Epub ahead of print]
Department of Surgery, Section of Urology, University of Pisa, Pisa, Italy.

INTRODUCTION: Erectile dysfunction has been widely investigated as the major factor responsible for sexual bother in patients after radical prostatectomy (RP); painful orgasm (PO) is one element of this bother, but little is known about its prevalence and its effects on sexual health. AIM: This study aims to investigate the prevalence of PO and to identify potential risk factors. MAIN OUTCOME MEASURES: A total of 1,411 consecutive patients underwent open (radical retropubic prostatectomy) or robot-assisted laparoscopic RP between 2002 and 2006. The patients were asked to complete a study-specific questionnaire. METHODS: Of a total of 145 questions, 5 dealt with the orgasmic characteristics. The questionnaire was also administered to a comparison group of 442 persons, matched for age and area of residency. RESULTS: The response rate was 91% (1,288 patients). A total of 143 (11%) patients reported PO. Among the 834 men being able to have an orgasm, the prevalence was 18% vs. 6% in the comparison group (relative risk [RR] 2.8, 95% confidence interval [CI] 1.7-4.5). When analyzed as independent variables, bilateral seminal vesicle (SV)-sparing approach (RR 2.33, 95% CI 1.0-5.3, P = 0.045) and age <60 years were significantly related to the presence of PO (95% CI 0.5-0.9, P = 0.019). After adjustment for age, bilateral SV-sparing still remained a significant predictor for occurrence of PO. CONCLUSIONS: We found that PO occurs significantly more often in patients undergoing bilateral SV-sparing RP when compared with age-matched comparison population.

11. Murzi M, Cerillo AG, Miceli A, Bevilacqua S, Kallushi E, Farneti P, Solinas M, Glauber M. Antegrade and retrograde arterial perfusion strategy in minimally invasive mitral-valve surgery: a propensity score analysis on 1280 patients. Eur J Cardiothorac Surg. 2013 Feb 12. [Epub ahead of print]
Fondazione Toscana Gabriele Monasterio, G. Pasquinucci Heart Hospital, Massa, Italy.

OBJECTIVES: Recent studies have suggested an increased risk of stroke in patients undergoing minimally invasive mitral-valve surgery with retrograde perfusion when compared with antegrade perfusion. The aim of the present study was therefore to evaluate the impact on early outcome of retrograde arterial perfusion (RAP) strategy vs antegrade arterial perfusion strategy in a consecutive large cohort of patients who underwent minimally invasive mitral-valve surgery through a right minithoracotomy. METHODS: Between 2003 and 2012, 1280 consecutive patients underwent first-time minimally invasive mitral-valve surgery at our institution. A total of 167 (13%) of these patients received a retrograde perfusion, while 1113 (87%) received antegrade perfusion. Logistic analysis was used to evaluate outcomes and risk factors for stroke. Treatment selection bias was controlled by constructing a propensity score from core patient characteristics. The propensity score was the probability of receiving retrograde perfusion and was included along with the comparison variable in the multivariable analyses of outcome. RESULTS: The overall frequency of in-hospital mortality was 1.1% (14/1280) and postoperative stroke was 1.6% (21/1280). After adjusting for the propensity score, RAP was associated with a higher incidence of stroke (5 vs 1%; P = 0.002), postoperative delirium (14 vs 5%, P = 0.001) and aortic dissection (1.7 vs 0%; P = 0.01). Multivariable regression analysis revealed that the use of retrograde perfusion was an independent risk factor for stroke [odds ratio (OR) 4.28; P = 0.02] and postoperative delirium (OR 3.51; P = 0.001). CONCLUSIONS: Minimally invasive mitral valve procedure can be performed with low morbidity and mortality. The use of retrograde perfusion is associated with a higher incidence of neurological complications and aortic dissection when compared with antegrade perfusion. Central aortic cannulation allows the avoidance of complications associated with retrograde perfusion while extending the suitability of minimally invasive mitral procedures also to those patients who have an absolute contraindication to femoral artery cannulation.

Breve commento a cura di Nerina Agabiti
Si tratta di uno studio dove vengono confrontati gli esiti clinici a breve termine di due procedure chirurgiche nell’ambito del trattamento chirurgico della malattia valvoare cardiaca. Negli anni recenti si è affermata una tecnica cardiochirurgica poco invasiva per il trattamento della malattia valvolare mitralica. La tecnica risulta associate a ridotti tempi ospedalieri, meno dolore, più precoce ritorno alle attività lavorative e potenziale riduzione dei costi sanitari. Tuttavia è ancora oggetto di dibattito la probabilità di eventi avversi ad essa correlata. E’ stato infatti documentato un eccesso di rischio per ictus cerebrale rispetto alla tecnica tradizionale sternotomica. Questo studio osservazionale retrospettivo,condotto in un centro cardiochirurgico a Massa, ha coinvolto una coorte di 1280 pazienti con malattia valvolare cardiaca mitralicaoperati nel periodo dal 2003 al 2012 co la nuova tecnica mini-invasiva. E’ stato confrontato il rischio di eventi clinici avversi a breve termine (30 giorni) tra colori ai quali era stata applicata una “perfusione arteriosa retrograda” (n=167) e colora i quali hanno ricevuto una“perfusione arteriosa anterograda” (n=1113). La mortalità intraospedaliera era pari a 1.1% e l’incidenza di ictus cerebrale 1.6%. Tenendo conto della eterogeneita tra i gruppi a confronto dei fattori influenzanti l’accesso all’una o all’altra tecnica riperfusiva (propensity adjustment) la perfusione retrogradaè risultata associata a ad un alta incidenza di ictus cerebrale, delirio postoperatorio e dissezione aortica. Gli autori sostengono che la tecnica di “perfusione anterograda” è sicura nella maggior parte dei pazienti e si associa a bassa incidenza di complicanze neurologiche.

12. Monami M, Mannucci E. Efficacy and safety of degludec insulin: a meta-analysis of randomised trials. Curr Med Res Opin. 2013 Apr;29(4):339-42. doi: 10.1185/03007995.2013.772507. Epub 2013 Feb 13.
Section of Geriatric Cardiology and Medicine, Department of Cardiovascular Medicine, University of Florence and Careggi Teaching Hospital , Florence , Italy.

Abstract Objectives: Degludec is a novel long-acting insulin analogue, providing an adequate supply of basal insulin over 24 hours with one daily injection, with a supposed greater reproducibility and flexibility than other basal insulins. Methods: An extensive search of Medline and the Cochrane Library for 'degludec' was performed, up to July 1st, 2012, collecting all randomised trials with a duration of at least 16 weeks and enrolling patients with diabetes. The principal outcome was the effect of degludec, compared with other basal insulins, on endpoint HbA1c and hypoglycaemia. Secondary outcomes included BMI, FPG at endpoint, and the incidence of cardiovascular events and cancer. Results: In the four trials comparing degludec with glargine, endpoint HbA1c was similar in the two groups, whereas FPG was significantly lower in degludec-treated patients. Degludec was associated with a lower rate of overall and nocturnal hypoglycaemia in type 2 and type 1 diabetes, respectively. No differences were observed for cardiovascular events and cancer. Study limitations: The number of available trials and the duration of exposure were limited, so the results obtained should be considered preliminary. Conclusions: Degludec appears to be associated with a lower incidence of hypoglycaemia in comparison with glargine, for similar levels of glycaemic control. The use of this agent could represent one step further in insulin therapy.

13. Salamanna F, Fini M, Parrilli A, Cadossi M, Aldini NN, Giavaresi G, Luciani D, Giannini S. Histological, histomorphometric and microtomographic analyses of retrieval hip resurfacing arthroplasty failed at different times. BMC Musculoskelet Disord. 2013 Jan 30;14:47. doi: 10.1186/1471-2474-14-47.
Rizzoli Research Innovation Technology, Rizzoli Orthopaedic Institute, Bologna, Italy.

BACKGROUND: Metal-on-metal hip resurfacing arthroplasty (HR) has been gaining popularity especially for young and active patients. Although different series report good mid-term results, the long-term outcome and failure mechanisms are still concerning. In this consecutive revision case series, 9 retrieved specimens of a failed Birmingham Hip Resurfacing (BHR) were divided according to the time to fracture: 3 specimens failed at less than 6 months (Group 1), 3 failed between 6 months and 3 years (Group 2) and 3 failed later than 3 years (Group 3). The objective of the study was to examine by a specific quantitative histomorphometry and microtomography (micro-CT) method the characteristics of bone quality and its microarchitecture in retrieved metal-on-metal HR. METHODS: A series of 948 BHR were performed between 2001 and 2009. Among these implants 10 failures occurred and nine of these underwent revision surgery and were examined by histomorphometry and micro-CT. RESULTS: Histomorphometry showed a significant increase in trabecular separation (Tb.Sp) in Group 3 in comparison with Group 1 (113%, p < 0.05). In the top region, micro-CT showed that Groups 2 and 3 presented significant lower bone volume (Group 2: 61%, p < 0.005; Group 3: 1%, p < 0.05), trabecular number (Group 2: 53%, p < 0.005; Group 3: 40%, p < 0.05), and higher Tb.Sp (Group: 71%,p < 0.05) when compared to Group 1. Additionally, histomorphometry showed that the top regions in Group 1 had a significantly lower mean percentage of empty osteocyte lacunae than the top regions in both Group 2 and 3 (p < 0.05). CONCLUSIONS: This study showed that the morphometric parameters considered are crucial for a good understanding of mechanical properties of HR and may be of significant importance in the pathogenesis of HR failure particularly in the development of late fractures.

14. Mischie AN, Nazzaro MS, Fiorilli R, De Felice F, Musto C, Confessore P, Parma A, Boschetti C, Violini R. Head-to-head comparison of sirolimus-eluting stent versus bare metal stent evaluation of the coronary endothelial dysfunction in the same patient presenting with multiple coronary artery lesions: The CREDENTIAL study. Catheter Cardiovasc Interv. 2013 Jan 29. doi: 10.1002/ccd.24844. [Epub ahead of print]
U.O. Cardiologia Interventistica, Ospedale San Camillo, Gianicolense n. 87, 00152, Roma, Italy; Department of Cardiology, "Bagdasar-Arseni" Emergency Hospital, 12 Berceni Street, 4th Sector, 041915, Bucharest, Romania.

OBJECTIVES: To assess the endothelial dysfunction (ED) after bare metal stents (BMS) and sirolimus eluting stents (SES) implantation in the same patient, overcoming the confounding role of individual variables. BACKGROUND: SES reduce restenosis rate compared to BMS but causes more ED. ED is a potentially unsafe phenomenon, since it is the first step in the cascade of atherosclerosis. Studies showing more pronounced ED with drug eluting stents than BMS involved different series of patients, making the comparison difficult because endothelial function (EF) is responsive to many risk factors. METHODS: we designed a prospective comparison of 6 months post-deployment EF of SES versus BMS implanted in the same patient, but in different coronary segments. Forty-eight lesions were randomly assigned on a 1:1 allocation using block sizing of 4 according to a computer-generated sequence (SAS System, Version 9.1) basis to treatment with SES or BMS. The EF was evaluated by measuring vessel diameter variation in the stented segment, before and after selective intracoronary infusion of acetylcholine (iiAch). RESULTS: In eligible patients, the relative magnitudes of major vasoconstriction were 2.6, 2.9, 4.6, and 3.1 at 5 mm proximal and 5, 10 and 20 mm distal to the stent edge. Overall, a 3.5-fold major distal vasoconstriction after iiAch of SES vs. BMS was calculated. CONCLUSIONS: in the same patients, but treating different coronary segments, SES implantation induces a higher rate of vasoconstriction compared to BMS. The increased vasoconstriction after iiAch is an indicator of ED.© 2013 Wiley Periodicals, Inc.

15. Chieffo A, Buchanan GL, Van Mieghem NM, Tchetche D, Dumonteil N, Latib A, van der Boon RM, Vahdat O, Marcheix B, Farah B, Serruys PW, Fajadet J, Carrié D, de Jaegere PP, Colombo A. Transcatheter aortic valve implantation with the Edwards SAPIEN versus the Medtronic CoreValve Revalving system devices: a multicenter collaborative study: the PRAGMATIC Plus Initiative (Pooled-RotterdAm-Milano-Toulouse In Collaboration). J Am Coll Cardiol. 2013 Feb 26;61(8):830-6. doi: 10.1016/j.jacc.2012.11.050. Epub 2013 Jan 16.
San Raffaele Scientific Institute, Milan, Italy.

OBJECTIVES: The aim of this study was to compare outcomes after transfemoral transcatheter aortic valve implantation with the Medtronic CoreValve (MCV) versus the Edwards SAPIEN/SAPIEN XT transcatheter heart valve (ESV) for severe aortic stenosis. BACKGROUND: No large matched comparison study has been conducted so far evaluating both commercially available devices. METHODS: The data from databases of 4 experienced European centers were pooled and analyzed. Due to differences in baseline clinical characteristics, propensity score matching was performed. Study objectives were Valve Academic Research Consortium outcomes at 30 days and 1 year. RESULTS: In total, 793 patients were included: 453 (57.1%) treated with the MCV and 340 (42.9%) with the ESV. After propensity matching, 204 patients were identified in each group. At 30 days, there were no differences in all-cause mortality (MCV, 8.8% vs. ESV, 6.4%; hazard ratio [HR]: 1.422; 95% confidence interval [CI]: 0.677 to 2.984; p = 0.352), cardiovascular mortality (MCV, 6.9% vs. ESV, 6.4%; HR: 1.083; 95% CI: 0.496 to 2.364; p = 0.842), myocardial infarction (MCV, 0.5% vs. ESV, 1.5%; HR: 0.330; 95% CI: 0.034 to 3.200; p = 0.339), stroke (MCV, 2.9% vs. ESV, 1.0%; HR: 3.061; 95% CI: 0.610 to 15.346; p = 0.174), or device success (MCV, 95.6% vs. ESV, 96.6%; HR: 0.770; 95% CI: 0.281 to 2.108; p = 0.611). Additionally, there were no differences in major vascular complications (MCV, 9.3% vs. ESV, 12.3%; HR: 0.735; 95% CI: 0.391 to 1.382; p = 0.340) or life-threatening bleeding (MCV, 13.7% vs. ESV, 8.8%; HR: 1.644; 95% CI: 0.878 to 3.077; p = 0.120). MCV was associated with more permanent pacemakers (22.5% vs. 5.9%; HR: 4.634; 95% CI: 2.373 to 9.050; p < 0.001). At 1 year, there were no differences in all-cause (MCV, 16.2% vs. ESV, 12.3%; HR: 1.374; 95% CI: 0.785 to 2.407; p = 0.266) or cardiovascular (MCV, 8.3% vs. ESV, 7.4%; HR: 1.145; 95% CI: 0.556 to 12.361; p = 0.713) mortality. CONCLUSIONS: No differences between the 2 commercially available transfemoral transcatheter aortic valve implantation devices were observed at the adjusted analysis in Valve Academic Research Consortium outcomes except for the need for permanent pacemakers with the MCV.

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