Comparabilità e valutazione dei servizi sanitari

  • Nerina Agabiti1

  1. Comparabilità e valutazione dei servizi sanitari
Nera Agabiti -

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Ricerca bibliografica periodo dal 16 aprile – 30 giugno 2014

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(((“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 (“2014/04/16”[PDat] : “2014/06/30”[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]))
1. Lopci E(1), Grassi I(2), Chiti A(3), Nanni C(2), Cicoria G(4), Toschi L(5), Fonti C(2), Lodi F(2), Mattioli S(6), Fanti S(2). PET radiopharmaceuticals for imaging of tumor hypoxia: a review of the evidence. Am J Nucl Med Mol Imaging. 2014 Jun 7;4(4):365-84. eCollection 2014.
Author information: (1)Department of Nuclear Medicine, University Hospital S. Orsola-Malpighi Bologna, Italy ; Department of Nuclear Medicine, Humanitas Clinical and Research Center Rozzano, Italy. (2)Department of Nuclear Medicine, University Hospital S. Orsola-Malpighi Bologna, Italy. (3)Department of Nuclear Medicine, Humanitas Clinical and Research Center Rozzano, Italy. (4)Department of Medical Physics, University Hospital S. Orsola-Malpighi Bologna, Italy. (5)Department of Medical Oncology, Humanitas Clinical and Research Center Rozzano, Italy. (6)Division of Thoracic Surgery, University Hospital S. Orsola-Malpighi Bologna, Italy.

Hypoxia is a pathological condition arising in living tissues when oxygen supply does not adequately cover the cellular metabolic demand. Detection of this phenomenon in tumors is of the utmost clinical relevance because tumor aggressiveness, metastatic spread, failure to achieve tumor control, increased rate of recurrence, and ultimate poor outcome are all associated with hypoxia. Consequently, in recent decades there has been increasing interest in developing methods for measurement of oxygen levels in tumors. Among the image-based modalities for hypoxia assessment, positron emission tomography (PET) is one of the most extensively investigated based on the various advantages it offers, i.e., broad range of radiopharmaceuticals, good intrinsic resolution, three-dimensional tumor representation, possibility of semiquantification/quantification of the amount of hypoxic tumor burden, overall patient friendliness, and ease of repetition. Compared with the other non-invasive techniques, the biggest advantage of PET imaging is that it offers the highest specificity for detection of hypoxic tissue. Starting with the 2-nitroimidazole family of compounds in the early 1980s, a great number of PET tracers have been developed for the identification of hypoxia in living tissue and solid tumors. This paper provides an overview of the principal PET tracers applied in cancer imaging of hypoxia and discusses in detail their advantages and pitfalls.

2. Spandonaro F(1), Ayala F, Berardesca E, Chimenti S, Girolomoni G, Martini P, Peserico A, Polistena B, Puglisi Guerra A, Vena GA, Altomare G, Calzavara Pinton P. The cost effectiveness of biologic therapy for the treatment of chronic plaque psoriasis in real practice settings in Italy. BioDrugs. 2014 Jun;28(3):285-95. doi: 10.1007/s40259-014-0084-3.
Author information: (1)University of Rome Tor Vergata, Via Columbia 2, 00133, Rome, Italy,

BACKGROUND AND OBJECTIVES: Biologic therapies are considered to be cost effective by leading Health Technology Assessment (HTA) agencies and, therefore, eligible for reimbursement by public health services. However, biologic therapies entail sizable incremental costs and, besides, have a considerable financial impact that in Italy amounts to 13.7 % of the national health service's pharmaceutical expenditure. In the reimbursability decision process, an important role is played by both the drug efficacy data observed in pre-licensing RCTs and the economic modelling assumptions, as they give evidence on cost effectiveness. The administration of therapies in real practice settings is likely to produce a significant deviation from the results predicted by the models, theoretically outweighing the assumption on which the decision process is founded. This is a matter of concern for public health services and, consequently, an interesting topic to investigate. METHODS: To overcome the lack of knowledge concerning the actual cost effectiveness of biologic therapies for the treatment of plaque psoriasis in the clinical practice setting in Italy, an observational study was conducted in 12 specialist centres on patients switching to biologic therapy within a 6-month enrolment window. RESULTS: The study confirms in clinical practice the efficacy of the switch to biologic therapies, analysed using a number of clinical [Psoriasis Area and Severity Index (PASI), pain visual analogue scale (VAS) and itching VAS] and quality-of-life parameters. A general health-related quality of life (HR-QOL) improvement, with a 0.23 quality-adjusted life-year (QALY) mean gain per patient, has been reported in the 6-month observation period. The direct medical costs to treat plaque psoriasis with biologic therapies amount to 15,073.7 per year (prior to their enrolment, the same patients cost 2,166.2 on an annual basis). After the switch to biologic agents, the cost per QALY during the first year of treatment amounts to 28,656.3. CONCLUSION: At least in the short-term, the clinical practice of the specialised Italian centres taking part in the study confirms that switching patients to a biologic drug produces an incremental cost-effectiveness ratio comparable with the values predicted by the HTA bodies.

3. Guidetti D(1), Spallazzi M, Baldereschi M, Di Carlo A, Ferro S, Rota E Morelli N, Immovilli P, Toni D, Polizzi BM, Inzitari D; Italy Project-Working Group. Post-stroke rehabilitation in Italy: inconsistencies across regional strategies. Eur J Phys Rehabil Med. 2014 Jun;50(3):335-41. Epub 2014 Feb 13.
Collaborators: Inzitari D, Maria Polizzi B, Baldereschi M, Consoli D, Candelise L, Di Carlo A, Fieschi C, Guidetti D, Provinciali L, Rasura M, Luisa Sacchetti M, Silvestrini M, Toni D. Author information: (1)Department of Neurology G. da Saliceto Hospital, Piacenza, Italy -

BACKGROUND: Remarkable differences among European countries have been found in stroke rehabilitation models, owing to the fact that stroke rehabilitation services are embedded in health care systems. Comprehensive data on service utilization by stroke survivors in Italy are lacking, but would be instrumental in improving efficiency and effectiveness of post-acute stroke care, and consequently, in containing costs and improving outcomes. AIM: The purpose of the present study was to survey the Italian regional legislations in order to examine the provision of rehabilitation services for stroke survivors in Italy. DESIGN: This is a cross-sectional, observational study. SETTING: Post-stroke intra- and extra-hospital rehabilitation. POPULATION: All decrees and resolutions as to post-acute stroke rehabilitation were collected from each Italian region. METHOD: All decrees and resolutions were examined by the means of a check list including quantitative and qualitative characteristics, selected in accordance with national official recommendations. Each completed check list was then sent to each regional reference person, who filled in the section on the implementation of the indications and compliance. RESULTS: The study was carried out from November 2009 to September 2010. The documents were collected from 19 out of the 20 Italian regions. The results of the study indicate that there are many, remarkable regional variations in health policies concerning post-stroke care. Instruments for evaluation and criteria for allocating stroke patients to proper rehabilitation setting vary across regions, but data on the potential impact of these variations on clinical outcomes are still lacking. CONCLUSION: The study highlights the issue that, in Italy, delivery of post-stroke rehabilitation services is not uniform nation-wide and varies substantially across regions. The lack of a comprehensive post-acute stroke strategy is a major obstacle to service availability. CLINICAL REHABILITATION IMPACT: The study results advocate the need for a consistent and comprehensive strategic planning of post-stroke rehabilitation in Italy.

4. Biffi M(1), Melissano D, Rossi P, Kaliska G, Havliĉek A, Pelargonio G, Romero R, Guastaferro C, Menichelli M, Vireca E, Frisoni J, Boriani G, Malacky T. The OPTI-MIND study: a prospective, observational study of pacemaker patients according to pacing modality and primary indications. Europace. 2014 May;16(5):689-97. doi: 10.1093/europace/eut387. Epub 2014 Feb 4.
Author information: (1)Institute of Cardiology, University of Bologna, Bologna 40138, Italy.

AIMS: The OPTI-MIND study aims to collect 2-year clinical outcomes of pacemaker patients in real-world clinical practice, overall and according to patient characteristics and pacemaker settings. METHODS AND RESULTS: The present analysis of the OPTI-MIND study describes the programmed device settings after discharge from the pacemaker implant. The objective was to determine whether these settings fit recent guidelines for device-programmed physiological pacing based on the preservation of atrioventricular synchrony, avoiding unnecessary pacing, ensuring rate increase during exercise or preventing neurally mediated symptoms. A total of 1740 patients were enroled at 68 centres worldwide. Baseline patient characteristics and device programming settings are available in 1674 of 1740 patients (96%). Guidelines to ensure physiological pacing were followed in 41% of patients: in patients with sinus node disease (SND), and without atrioventricular block (AVB), device programming could have led to unnecessary right ventricular pacing in 38% of patients. In SND patients with chronotropic incompetence, assisted rate increase during exercise was not programmed in 42% of patients. In 11% of patients with AVB, atrioventricular (AV) synchrony was not pursued; the main drivers being advanced age and history of atrial fibrillation. Patients with both SND and AVB were generally programmed physiologically (87%). CONCLUSION: The present analysis showed that frequent deviations occurred when comparing the device settings at discharge from the pacemaker implant in clinical practice to the available guidelines on pacing mode selection. Analysis of 2-year outcomes in the OPTI-MIND study will provide an insight into whether specific physiological settings could improve the quality of pacing with a positive effect on patient outcome.

5. Larouche A(1), Becker A(2), Schiffmann J(3), Roghmann F(4), Gandaglia G(5), Hanna N(1), Tian Z(6), Perrotte P(7), Schlomm T(8), Graefen M(9), Ahyai S(10), Trinh QD(11), Karakiewicz PI(1), Sun M(6). Comparison between complication rates of laser prostatectomy electrocautery transurethral resection of the prostate: A population-based study. Can Urol Assoc J. 2014 May;8(5-6):E419-24. doi: 10.5489/cuaj.1790.
Author information: (1)Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Centre, Montreal, QC; ; Department of Urology, University of Montreal Health Centre, Montreal, QC; (2)Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Centre, Montreal, QC; ; Martini-Clinic, Prostate Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; ; Department of Urology, University-Hospital Hamburg-Eppendorf, Hamburg, Germany; (3)Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Centre, Montreal, QC; ; Martini-Clinic, Prostate Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; (4)Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Centre, Montreal, QC; ; Department of Urology, Ruhr University Bochum, Marienhospital, Herne, Germany; (5)Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Centre, Montreal, QC; ; Department of Urology, Vita-Salute, San Raffaele University, Milan, Italy; (6)Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Centre, Montreal, QC; (7)Department of Urology, University of Montreal Health Centre, Montreal, QC; (8)Martini-Clinic, Prostate Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; ; Department of Urology, Section for Translational Prostate Cancer Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; (9)Martini-Clinic, Prostate Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; (10)Department of Urology, University-Hospital Hamburg-Eppendorf, Hamburg, Germany; (11)Department of Surgery, Division of Urology, Brigham and Women's Hospital/Dana-Farber Cancer Institut, Harvard Medical School, Boston, MA.

INTRODUCTION: We compare the complication rates and length of stay (LOS) of laser transurethral resection of the prostate (L-TURP) versus electrocautery transurethral resection of the prostate (E-TURP) in a population-based cohort. L-TURP has shown enhanced intraoperative safety and equivalent efficacy relative to E-TURP in several high volume centres. METHODS: Relying on the Florida Datafile as part of the Healthcare Cost and Utilization Project State Inpatient Databases (SID) between 2006 and 2008, we identified 8066 men with benign prostate hyperplasia who underwent L-TURP or E-TURP. Chi-square and Mann-Whitney tests were used to compare baseline characteristics. A multivariable linear regression model was used to analyze the effect of L-TURP versus E-TURP on complication rates and LOS. RESULTS: Overall complication rates did not differ significantly for L-TURP compared to E-TURP in univariable (8.8 vs. 7.4%, p = 0.1) and multivariable analyses (odds ratio [OR]: 1.06, confidence interval [CI]: 0.85-1.32, p = 0.6). Individuals undergoing E-TURP were less likely to experience a LOS in excess of 1 day (46.2 vs. 59.7%, p < 0.001). A lower risk to experience a LOS in excess of 1 day was confirmed for patients undergoing L-TURP after a multivariable linear regression model (OR: 0.37, CI: 0.23-0.58, p < 0.001), but not for a LOS in excess of 2 days (OR: 0.96, CI: 0.83-1.10, p = 0.2). CONCLUSIONS: Patient characteristics and perioperative safety were similar for L-TURP and E-TURP patients. However, LOS patterns demonstrated a modest benefit for L-TURP compared to E-TURP patients.

6. Cecinato P(1), Fuccio L(1), Azzaroli F(1), Lisotti A(1), Correale L(2), Hassan C(3), Buonfiglioli F(1), Cariani G(1), Mazzella G(1), Bazzoli F(1), Muratori R(1). Extracorporeal shock wave lithotripsy for difficult common bile duct stones: a comparison between 2 different lithotripters in a large cohort of patients. Gastrointest Endosc. 2014 Jun 25. pii: S0016-5107(14)01430-8. doi: 10.1016/j.gie.2014.04.059. [Epub ahead of print]
Author information: (1)Gastroenterology Unit, Department of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy. (2)Im3D Medical Imaging Lab, Turin, Italy. (3)Department of Gastroenterology and Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.

BACKGROUND: Extracorporeal shock wave lithotripsy (ESWL) for difficult common bile duct (CBD) stones is a safe and effective treatment strategy allowing for bile duct clearance in approximately 90% of patients with a low incidence of mild adverse events. OBJECTIVE: To compare the CBD clearance rates achieved after ESWL performed with 2 different lithotripters (Siemens Lithostar Plus and Storz Modulith SLX-F2) in a large cohort of patients with difficult CBD stones. DESIGN: A retrospective analysis of a prospectively collected database. SETTING: Tertiary care center. PATIENTS: All of the consecutive patients who underwent ESWL because of difficult CBD stones between 1990 and 2012 were considered suitable for inclusion. INTERVENTIONS: ESWL with Lithostar Plus or with Modulith SLX-F2. MAIN OUTCOME MEASUREMENTS: CBD clearance. RESULTS: Three hundred ninety-two patients with difficult CBD stones were treated; 199 patients were treated with the Lithostar Plus and 193 patients with the Modulith SLX-F2. CBD clearance was achieved in 349 patients (89.0%) with no significant difference between the patients treated with Lithostar Plus and those treated with Modulith SLX-F2 (90.5% vs 87.6%; P = .45). Patients treated with Modulith SLX-F2 underwent a significantly lower number of ESWL sessions (3 [range, 2 to 4] vs 3 [range, 2 to 4]; P = .0015), had a lower incidence of ESWL-related adverse events (5.2% vs 13.6%; P = .009), and never required opioid analgesia (P < .001). LIMITATIONS: Retrospective design. CONCLUSIONS: The Modulith SLX-F2 allows the same clearance rate as the Lithostar Plus but has a significantly lower incidence of adverse events and requires fewer ESWL sessions.

7. Costopoulos C(1), Latib A, Naganuma T, Miyazaki T, Sato K, Figini F, Sticchi A, Carlino M, Chieffo A, Montorfano M, Colombo A. Comparison of early clinical outcomes between absorb bioresorbable vascular scaffold and everolimus-eluting stent implantation in a real-world population. Catheter Cardiovasc Interv. 2014 Jun 6. doi: 10.1002/ccd.25569. [Epub ahead of print]
Author information: (1)Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy; Imperial College London, London, United Kingdom.

OBJECTIVES: To compare the early clinical outcomes between ABSORB bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA) and cobalt chromium everolimus-eluting stents in real-world patients with mostly complex disease. BACKGROUND: BVS represents the most interesting development in the drug-eluting stent field over recent years with promising results emerging from clinical trials. Available data however on the use of the ABSORB in real-world patients is limited. METHODS: All patients (n = 92) treated with BVS and 1296 patients treated with EES were included in this study. Propensity score matching was performed to adjust for differences in baseline clinical characteristics, yielding 92 patient pairs (BVS = 92 patients with 137 lesions and EES = 92 patients with 124 lesions). Clinical outcomes were examined between the 2 groups at 6-months. RESULTS: In both groups, most lesions were classified as either B2 or C (83.9% vs. 77.4%, P = 0.19). Predilatation (97.8% vs. 75.8%, P < 0.01) as well as postdilation (99.3% vs. 77.4%, P < 0.01) was more common in the BVS group. Clinical outcomes at 6-months were similar between the two groups with respect to both target lesion revascularization (3.3% vs. 5.4%, P = 0.41) and major adverse cardiac events (defined as the composite of target vessel revascularization, follow-up myocardial infraction and all-cause death) (3.3% vs. 7.6%, P = 0.19). CONCLUSIONS: ABSORB BVS for the treatment of complex lesions appears to be associated with good procedural and early clinical outcomes similar to those observed with conventional drug-eluting stents. Larger studies with long-term follow-up are required in order to fully assess the role of BVS in the treatment of such lesions and how this compares with that of conventional stents. © 2014 Wiley Periodicals, Inc.

8. Pompili C(1), Detterbeck F(2), Papagiannopoulos K(3), Sihoe A(4), Vachlas K(3), Maxfield MW(2), Lim HC(4), Brunelli A(3). Multicenter international randomized comparison of objective and subjective outcomes between electronic and traditional chest drainage systems. Ann Thorac Surg. 2014 Aug;98(2):490-7. doi: 10.1016/j.athoracsur.2014.03.043. Epub 2014 Jun 4.
Author information: (1)Department of Thoracic Surgery, Ospedali Riuniti Ancona, Ancona, Italy. Electronic address: (2)Department of Thoracic Surgery, Yale-New Haven Hospital, Yale University, New Haven, Connecticut. (3)Division of Thoracic Surgery, St. James's University Hospital, Leeds, United Kingdom. (4)Department of Thoracic Surgery, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.

BACKGROUND: The aim of this study was to assess the impact of digital versus traditional drainage devices on chest tube removal and patient satisfaction. METHODS: A randomized trial of digital versus traditional devices after lobectomy/segmentectomy was conducted at 4 international centers (United Kingdom, Europe, Asia, United States). Patients were managed with overnight suction followed by gravity drainage. Chest tubes were removed when an air leak was not evident anymore and the drained fluid was less than 400 mL/d. RESULTS: The groups (digital, 191 patients; traditional, 190 patients) were well matched for baseline and surgical characteristics. There were 325 lobectomies/bilobectomies and 56 segmentectomies, 308 of which were performed by video-assisted thoracic surgery (VATS). Patients randomized to digital systems had a significantly shorter air leak duration (1.0 versus 2.2 days; p = 0.001), duration of chest tube placement (3.6 versus 4.7 days; p = 0.0001), and postoperative length of stay (4.6 versus 5.6 days; p < 0.0001). Subjective end points revealed a perceived improved ability to arise from bed (p = 0.008), system convenience for patients and personnel (p = 0.02), and the potential for being comfortable when discharged home with the device (p = 0.06). A mean difference of 2.6 days from air leak cessation to tube removal was observed, which was similar in the 2 groups (p = 0.7). Multivariable regression analysis showed that duration of chest tube placement after air leak cessation was directly associated with the amount of fluid drained during the first 48 hours (p = 0.01) and the duration of air leak (p = 0.008), independent of hospital location. CONCLUSIONS: Patients managed with digital drainage systems experienced a shorter duration of chest tube placement, shorter hospital stays, and higher satisfaction scores compared with those managed with traditional devices. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01747889.).

9. Biancari F(1), Gudbjartsson T(2), Heikkinen J(3), Anttila V(3), Mäkikallio T(4), Jeppsson A(5), Thimour-Bergström L(5), Mignosa C(6), Rubino AS(6), Kuttila K(7), Gunn J(7), Wistbacka JO(8), Teittinen K(9), Korpilahti K(10), Onorati F(11), Faggian G(11), Vinco G(12), Vassanelli C(12), Ribichini F(12), Juvonen T(3), Axelsson TA(2), Sigurdsson AF(13), Karjalainen PP(14), Mennander A(15), Kajander O(15), Eskola M(15), Ilveskoski E(15), D'Oria V(16), De Feo M(16), Kiviniemi T(7), Airaksinen KE(7). Comparison of 30-day and 5-year outcomes of percutaneous coronary intervention versus coronary artery bypass grafting in patients aged≤50 years (the Coronary aRtery diseAse in younG adultS Study). Am J Cardiol. 2014 Jul 15;114(2):198-205. doi: 10.1016/j.amjcard.2014.04.025. Epub 2014 May 2.
Author information: (1)Department of Surgery, Oulu University Hospital, Oulu, Finland. Electronic address: (2)Department of Cardiothoracic Surgery, Landspitali University Hospital, Reykjavík, Iceland. (3)Department of Surgery, Oulu University Hospital, Oulu, Finland. (4)Department of Internal Medicine, Oulu University Hospital, Oulu, Finland. (5)Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Göteborg, Sweden. (6)Cardiac Surgery Unit, Azienda Ospedaliero Universitaria (A.O.U.) Policlinico-Vittorio Emanuele, University of Catania, Catania, Italy. (7)Heart Center, Turku University Hospital and University of Turku, Turku, Finland. (8)Department of Anesthesiology, Vaasa Central Hospital, Vaasa, Finland. (9)Department of Surgery, Vaasa Central Hospital, Vaasa, Finland. (10)Department of Internal Medicine, Vaasa Central Hospital, Vaasa, Finland. (11)Division of Cardiac Surgery, University of Verona Medical School, Verona, Italy. (12)Division of Cardiology, Department of Medicine, University of Verona Medical School, Verona, Italy. (13)Department of Cardiology, Faculty of Medicine, University of Iceland, Reykjavík, Iceland. (14)Heart Center, Satakunta Central Hospital, Pori, Finland. (15)Heart Center, Tampere University Hospital, Tampere, Finland. (16)Department of Cardiothoracic and Respiratory Sciences, V. Monaldi Hospital, Naples, Italy.

Data on the outcome of young patients after coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are scarce. Data on 2,209 consecutive patients aged≤50 years who underwent CABG or PCI were retrospectively collected from 15 European institutions. PCI and CABG had similar 30-day mortality rates (0.8% vs 1.4%, p=0.27), late survival (at 5 years, 97.8% vs 94.9%, p=0.082), and freedom from stroke (at 5 years, 98.0% and 98.0%, p=0.731). PCI was associated with significantly lower freedom from major adverse cardiac and cerebrovascular events (at 5 years, 73.9% vs 85.0%, p<0.0001), repeat revascularization (at 5 years, 77.6% vs 92.5%, p<0.0001), and myocardial infarction (at 5 years, 89.9% vs 96.6%, p<0.0001) compared with CABG. These findings were confirmed in propensity score-adjusted and matched analyses. Freedom from major adverse cardiac and cerebrovascular events after PCI was particularly low in diabetics (at 5 years, 58.0% vs 75.9%, p<0.0001) and in patients with multivessel disease (at 5 years, 63.6% vs 85.1%, p<0.0001). PCI in patients with ST elevation myocardial infarction was associated with significantly better 5-year survival (97.5% vs 88.8%, p=0.001), which was driven by its lower 30-day mortality rate (1.5% vs 6.0%, p=0.017). In conclusion, patients aged≤50 years have an excellent immediate outcome after either PCI or CABG with similar long-term survival when used according to the current clinical practice. PCI was associated with significantly lower freedom from myocardial infarction and repeat revascularization.

Breve commento a cura di N. Agabiti
Sebbene esistano molte evidenze sull’efficacia dei trattamenti per la cardiopatia ischemica, pochi studi esaminano gli esiti nella categoria di età giovane-adulta. Lo studio di Biancari et al dà un contributo in questo ambito di ricerca valutando comparativamente l’efficacia del bypass aortocoronarico e dell’angioplastica percutanea in persone < 50 anni di età. I pazienti consecutivamente arruolati sono oltre 2200 e provengono da 15 centri europei. PCI e CABG risultano avere simili valori di mortalità a 30 giorni (0.8% vs 1.4%) e sopravvivenza a 5 anni (97,8% vs 94,9%) e “tempo libero da ictus cerebrale” (98% per entrambe le tecniche). Tuttavia la PCI è risultata associata a minore incidenza di eventi avversi a 5 anni: eventi maggiori cardio e cerebro vascolari, rivascolarizzazioni successive e infarto del miocardio. L’effetto è particolarmente evidente tra i pazienti con patologia coronarica multivascolare. Nonostante alcuni limiti metodologici, lo studio aggiunge elementi di conoscenza sul tema del confronto tra tecniche per la cura della cardiopatia ischemica.

10. Bogani G(1), Cromi A, Uccella S, Serati M, Casarin J, Pinelli C, Ghezzi F. Perioperative and long-term outcomes of laparoscopic, open abdominal, and vaginal surgery for endometrial cancer in patients aged 80 years or older. Int J Gynecol Cancer. 2014 Jun;24(5):894-900. doi: 10.1097/IGC.0000000000000128.
Author information: (1)Department of Obstetrics and Gynecology, University of Insubria, Del Ponte Hospital, Varese, Italy.

OBJECTIVE: This study was undertaken to evaluate the safety, feasibility, and the long-term effectiveness of laparoscopy in endometrial cancer patients aged 80 years or older. METHODS: Data of consecutive patients aged 80 years and older undergoing laparoscopic, open abdominal, and vaginal approaches were compared. Postoperative complications were graded per the Accordion Severity Classification. Survival outcomes within the first 5 years were analyzed using the Kaplan-Meier method. RESULTS: Among 726 patients, 63 (9%) were aged 80 years and older. Laparoscopic, open abdominal, and vaginal surgery were performed in 22 (35%), 25 (40%), and 16 (25%) cases, respectively. All laparoscopic procedures were completed laparoscopically, whereas a conversion from vaginal to open procedure occurred (0% vs 6%; P = 0.42). Patients undergoing laparoscopy experienced similar operative time (P > 0.05), lower blood loss (P < 0.05), and shorter hospital stay (P < 0.05) than patients undergoing open and vaginal surgery. No intraoperative complications were recorded. Laparoscopy is related to a lower rate of postoperative complications (P = 0.09) and Accordion grade greater than or equal to 2 complications (P = 0.05) in comparison to open abdominal and vaginal surgery. The route of surgical approaches did not influence the 5-year disease-free (P = 0.97, log-rank test) and overall (P = 0.94, log-rank test) survivals. CONCLUSIONS: Laparoscopy seems to represent a safe and effective treatment of endometrial cancer in women aged 80 years or older. Our data suggest that in elderly women, laparoscopic surgery improves perioperative outcomes compared with open and vaginal approaches without compromising long-term survival.

11. Brambilla AM(1), Aliberti S, Prina E, Nicoli F, Del Forno M, Nava S, Ferrari G, Corradi F, Pelosi P, Bignamini A, Tarsia P, Cosentini R. Intensive Care Med. 2014 Jul;40(7):942-9. doi: 10.1007/s00134-014-3325-5. Epub 2014 May 10. Helmet CPAP vs. oxygen therapy in severe hypoxemic respiratory failure due to pneumonia.
Author information: (1)Emergency Medicine Department, IRCCS Fondazione Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.

PURPOSE: The efficacy of noninvasive continuous positive airway pressure (CPAP) to improve outcomes in severe hypoxemic acute respiratory failure (hARF) due to pneumonia has not been clearly established. The aim of this study was to compare CPAP vs. oxygen therapy to reduce the risk of meeting criteria for endotracheal intubation (ETI). METHODS: In a multicenter randomized controlled trial conducted in four Italian centers patients with severe hARF due to pneumonia were randomized to receive helmet CPAP (CPAP group) or oxygen delivered with a Venturi mask (control group). The primary endpoint was the percentage of patients meeting criteria for ETI, including either one or more major criteria (respiratory arrest, respiratory pauses with unconsciousness, severe hemodynamic instability, intolerance) or at least two minor criteria (reduction of at least 30% of basal PaO2/FiO2 ratio, increase of 20% of PaCO2, worsening of alertness, respiratory distress, SpO2 less than 90%, exhaustion). RESULTS: Between February 2010 and 2013, 40 patients were randomized to CPAP and 41 to Venturi mask. The proportion of patients meeting ETI criteria in the CPAP group was significantly lower compared to those in the control group (6/40 = 15% vs. 26/41 = 63%, respectively, p < 0.001; relative risk 0.24, 95% CI 0.11-0.51; number needed to treat, 2) two patients were intubated in the CPAP group and one in the control group. The CPAP group showed a faster and greater improvement in oxygenation in comparison to controls (p < 0.001). In either study group, no relevant adverse events were detected. CONCLUSIONS: Helmet CPAP reduces the risk of meeting ETI criteria compared to oxygen therapy in patients with severe hARF due to pneumonia.

12. Martuscelli R(1), Toti P(2), Sbordone L(3), Guidetti F(4), Ramaglia L(5), Sbordone C(6). Five-year outcome of bone remodelling around implants in the maxillary sinus: assessment of differences between implants placed in autogenous inlay bone blocks and in ungrafted maxilla. Int J Oral Maxillofac Surg. 2014 Sep;43(9):1117-26. doi: 10.1016/j.ijom.2014.03.016. Epub 2014 Apr 26.
Author information: (1)Clinical Department of Head and Neck, School of Medicine, University of Naples "Federico II", Naples, Italy. (2)Private Practice and Department of Surgical, Medical, Molecular, and Critical Area Pathology, University of Pisa, Camaiore, Pisa, Italy. (3)Department of Medicine and Surgery, School of Medicine, University of Salerno, Baronissi, Salerno, Italy. Electronic address: (4)Complex Operating Unit of Maxillofacial Surgery, Azienda Ospedaliero - Universitaria Pisana, Pisa, Italy. (5)Department of Neurosciences, Reproductive and Odontostomatological Sciences, School of Medicine, University of Naples "Federico II", Naples, Italy. (6)Maxillo-Facial Surgery, School of Medicine, University of Naples "Federico II", Naples, Italy.

The placement of implants in the posterior maxillary area is considered a reliable procedure, offering recognized rehabilitative advantages. The aim of this study was to evaluate the performance of dental implants placed in the sinus floor augmented with a block autograft by comparing the outcomes over 5 years with those of dental implants positioned in non-augmented bone. This retrospective cohort study included 16 patients who had undergone prosthetic rehabilitation supported by dental implants between 2000 and 2006. One implant per patient was included and assigned to one of two predictor groups: grafted versus ungrafted maxillary sinus. Changes in marginal bone level (MBL) and apical bone level (ABL) over time, at 1, 3, and 5 years, were the primary outcome variables. Appropriate pair-wise comparison tests were performed. No significant differences were seen with regard to ABLs and among times between the grafted group (nine implants) and the ungrafted group (seven implants). Significant marginal bone resorption was found over time, primarily at the buccal aspect, in both study groups. The bone surrounding the apex of dental implants appeared stable after sinus augmentation in the grafted area. The behaviour of the two groups with regard to loss of MBLs over time was very similar.

13. Mineo TC(1), Sellitri F, Tacconi F, Ambrogi V. Quality of Life and Outcomes after Nonintubated versus Intubated Video-Thoracoscopic Pleurodesis for Malignant Pleural Effusion: Comparison by a Case-Matched Study. J Palliat Med. 2014 Jul;17(7):761-8. doi: 10.1089/jpm.2013.0617. Epub 2014 Apr 28.
Author information: (1)Department of Experimental Medicine and Surgery, Division of Thoracic Surgery, Policlinico Tor Vergata University , Rome, Italy .

Abstract Background: Malignant pleural effusion can be treated successfully by video-assisted thoracic surgery (VATS) talc pleurodesis. This procedure can also be performed using local anesthesia on nonintubated patients. Objectives: To evaluate quality of life and major outcomes after VATS talc pleurodesis performed under local anesthesia in nonintubated patients with malignant pleural effusion. Design: Retrospective, nonrandomized case-matched comparison (nonintubated versus intubated) pairing the patients by computer according to their clinical features. Setting/Subjects: Since 2002, 231 consecutive patients underwent uniport VATS talc pleurodesis under local anesthesia (nonintubated group). These patients were case matched with 231 homogeneous subjects, selected from a larger group that preferred general anesthesia (intubated group) in the same period. Measurements: Quality of life (European Organization for Research and Treatment of Cancer QLQ-C30 core questionnaire) and other major outcomes were considered. Results: Pleurodesis was successful in 198 (85.7%) nonintubated and 193 (83.5%) intubated patients, but the former group showed shorter total operating room time (65.8±7.5 versus 84.9±13.3 minutes, p<0.0001), duration of postoperative pleural fluid leakage (2.5±1.0 versus 4.0±1.5 days, p=0.014), postoperative hospital stay (3.1±2.5 versus 4.9±2.8 days, p=0.011), as well as lower perioperative mortality (0% versus 2.3%, p=0.017), morbidity (5.2% versus 9.0%, p=0.042), and costs (6,090±517 versus 9,660±713€, p=0.015). Quality of life presented a similar evolution between groups, however, the early postoperative improvement in physical function (p<0.05), global health (p<0.05), and dyspnea (p<0.01) was significantly greater in nonintubated patients. Significant improvements in respiratory exchanges, postoperative acute stress markers, and mental confusion were also documented. Effusion-free (p=0.35) and overall (p=0.52) survival was similar between groups. Conclusion: Nonintubated VATS talc pleurodesis can achieve similar results in pleural effusion to the same operation performed under general anesthesia but with earlier improvement of some quality-of-life domains as well as better mortality, morbidity, hospital stay, and costs.

14. Catheter Cardiovasc Interv. 2014 May 1;83(6):E193-206. doi: 10.1002/ccd.25416. Epub 2014 Feb 10. Meta-analysis of bioabsorbable versus durable polymer drug-eluting stents in 20,005 patients with coronary artery disease: an update. Lupi A(1), Gabrio Secco G, Rognoni A, Lazzero M, Fattori R, Sheiban I, Sante Bongo A, Bolognese L, Agostoni P, Porto I.
Author information: (1)Hospital Cardiology, "Maggiore della Carità" Hospital, Novara, Italy.

OBJECTIVES: To perform an updated meta-analysis comparing biodegradable polymer drug eluting stents (BP-DES) and durable polymer drug eluting stents (DP-DES). BACKGROUND: BP-DES have been suggested to reduce late stent thrombosis (LST) rates as compared to first generation DP-DES. Recently, second generation DP-DES have replaced older DES, but comparison of these stents with BP-DES has not yielded consistent results. METHODS: Medline/Web databases were searched for studies comparing BP-DES and DP-DES, and reporting rates of overall/cardiac mortality, myocardial infarction (MI), LST, target lesion revascularization (TLR) and target vessel revascularization (TVR) and late lumen loss (LLL), with a follow-up ≥6 months. RESULTS: Twenty studies (20,005 patients) were included in the meta-analysis. Median follow-up time was 1 year. Compared with DP-DES, BP-DES showed lower LLL (in stent: weighted mean difference WMD -0.45 mm, 95% CI -0.66 to -0.24 mm, P = 0.00001; in segment: WMD -0.15 mm, 95% CI = -0.24 to -0.06 mm, P = 0.001) and lower rates of LST (OR 0.51, 95% CI = 0.30 to 0.86, P = 0.01), although they did not improve mortality, MI, TLR, and TVR rates. BP-DES coated with sirolimus or novolimus, in comparison with biolimus or paclitaxel, were associated with reduced LLL (P < 0.0001 for subgroups). CONCLUSIONS: In comparison with DP-DES, BP-DES significantly reduce LLL and LST rates, without clear benefits on harder endpoints. The efficacy of BP-DES in preserving lumen patency seems larger for sirolimus and novolimus DES.

15. Nava F(1), Tramacere I, Fittipaldo A, Bruzzone MG, Dimeco F, Fariselli L, Finocchiaro G, Pollo B, Salmaggi A, Silvani A, Farinotti M, Filippini G. Survival effect of first- and second-line treatments for patients with primary glioblastoma: a cohort study from a prospective registry, 1997-2010. Neuro Oncol. 2014 May;16(5):719-27. doi: 10.1093/neuonc/not316. Epub 2014 Jan 23.
Author information: (1)Unit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy (F.N., I.T., A.F., M.F., G.F.); Unit of Neuroradiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy (M.G.B., L.F.); Department of Neurosurgery, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy; Department of Neurological Surgery, Johns Hopkins Medical School, Baltimore, Maryland (F.D.); Unit of Molecular Neuro-oncology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy (G.F.); Unit of Neuropathology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy (B.P.); Department of Neurology, Ospedale Alessandro Manzoni, Lecco, Italy (A.S.); Unit of Clinical Neuro-oncology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy (A.S.).

BACKGROUND: Prospective follow-up studies of large cohorts of patients with glioblastoma (GBM) are needed to assess the effectiveness of conventional treatments in clinical practice. We report GBM survival data from the Brain Cancer Register of the Fondazione Istituto Neurologico Carlo Besta (INCB) in Milan, Italy, which collected longitudinal data for all consecutive patients with GBM from 1997 to 2010. METHODS: Survival data were obtained from 764 patients (aged>16 years) with histologically confirmed primary GBM who were diagnosed and treated over a 7-year period (2004-2010) with follow-up to April 2012 (cohort II). Equivalent data from 490 GBM patients diagnosed and treated over the preceding 7 years (1997-2003) with follow-up to April 2005 (cohort I) were available for comparison. Progression-free survival (PFS) was available from 361 and 219 patients actively followed up at INCB in cohorts II and I, respectively. RESULTS: Survival probabilities were 54% at 1 year, 21% at 2 years, and 11% at 3 years, respectively, in cohort II compared with 47%, 11%, and 5%, respectively, in cohort I. PFS was 22% and 12% at 1 year in cohorts II and I. Better survival and PFS in cohort II was significantly associated with introduction of the Stupp protocol into clinical practice, with adjusted hazard ratios (HRs) of 0.78 for survival and 0.73 for PFS, or a 22% relative decrease in the risk of death and a 27% relative decrease in the risk of recurrence. After recurrence, reoperation was performed in one-fifth of cohort I and in one-third of cohort II but was not effective (HR, 1.05 in cohort I and 1.02 in cohort II). Second-line chemotherapy, mainly consisting of nitrosourea-based chemotherapy, temozolomide, mitoxantrone, fotemustine, and bevacizumab, improved survival in both cohorts (HR, 0.57 in cohort I and 0.74 in cohort II). Radiosurgery was also effective (HR, 0.52 in cohort II). CONCLUSIONS: We found a significant increase in overall survival, PFS, and survival after recurrence after 2004, likely due to improvements in surgical techniques, introduction of the Stupp protocol as a first-line treatment, and new standard protocols for second-line chemotherapy and radiosurgery after tumor recurrence. In both cohorts, reoperation after tumor recurrence did not improve survival.

Breve commento a cura di N. Agabiti
Tra i tumori maligni del cervello, il glioblastoma multiforme è la forma più comune e grave con picco di incidenza nell’età adulta (45-70 anni). Studi prospettici sono molto importanti per stimare l’impatto di nuovi trattamenti. Lo studio di Nava et al. è un interessante lavoro condotto presso la Fondazione Istituto Neurologico Carlo Besta di Milano in tema di trattamento del glioblastoma. La terapia del tumore è molto complessa. Ad oggi lo Stupp protocol è considerato il trattamento di prima linea ed include l’uso di farmaci specifici e concomitante radioterapia, mentre c’è ancora discussione su altri schemi terapeutici e sull’efficacia del re-intervento chirurgico. Nello studio sono stati arruolati prospetticamente 764 persone di età 16+ anni con diagnosi di glioblastoma primario confermato istologicamente lungo un periodo di 7 anni (2004-2010) e seguite fino al 2012 (coorte II). Il confronto è stato fatto con una coorte di 490 pazienti arruolati in un periodo precedente (1997-2003) e seguita fino al 2005 (coorte I). Di questi pazienti erano disponibili dati clinici e di laboratorio tra cui specifici markers molecolari di prognosi. La sopravvivenza a un anno è risultata in media del 54%, a due anni il 21%, a 3 anni l’11% nella coorte II più recente contro valori di 47%, 11% e 5% rispettivamente nella coorte I. L’applicazione dello Stupp protocol come prima linea di trattamento è risultato associato a migliore sopravvivenza (HR 0.78, coorte II). In sintesi, il miglioramento della prognosi in termini di sopravvivenza e di minor rischio di recidive si è osservato dopo il 2004. Gli Autori lo attribuiscono soprattutto dovuto a miglioramento delle tecniche chirurgiche, all’introduzione dello Stupp protocol come trattamento di prima linea ed anche a nuovi standard terapeutici di seconda linea (chemioterapia e radioterapia) usati in seguito a recidive. In entrambe le coorti, il re-intervento in seguito a recidive non migliora la sopravvivenza. Come evidenziano gli Autori, studi di coorte rappresentano il modo migliore per stimare l’effetto dei trattamenti di nuova introduzione laddove è difficile condurre trials clinici.

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