rubrica

Comparabilità e valutazione dei servizi sanitari

  •  Nerina Agabiti1

  • Marina Davoli1

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

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Ricerca bibliografica periodo dal 2 gennaio 2012 al 15 marzo 2012

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1. Burzotta F, Trani C, Mazzari MA, Tommasino A, Niccoli G, Porto I, Leone AM, Tinelli G, Coluccia V, De Vita M, Brancati M, Mongiardo R, Schiavoni G, Crea F. Vascular complications and access crossover in 10,676 transradial percutaneous coronary procedures. Am Heart J. 2012 Feb;163(2):230-8. Epub 2012 Jan 13.
Department of Cardiovascular Medicine, Catholic University of the Sacred Heart, Rome, Italy. f.burzotta@rm.unicatt.it

Abstract
BACKGROUND:
Randomized trials have shown that transradial approach, compared with transfemoral, reduces vascular complications (VCs) of coronary procedures in selected patients. Yet, radial approach is associated to a variety of access-site VC as well as to a higher failure rate compared with femoral access.
METHODS:
At our institution, from May 2005 to May 2010, we prospectively assessed the occurrence and outcome of VC in consecutive patients undergoing transradial percutaneous coronary procedures performed by trained radial operators. The need of access crossover to complete the procedure was also prospectively investigated. Vascular complications were classified as "radial related" or "nonradial related" (in the case of access crossover). Vascular complications were also classified "major" if requiring surgery and/or blood transfusions or causing hemoglobin drop >3 g/dL.
RESULTS:
Ten thousand six hundred seventy-six procedures were performed using a right radial (87.5%), left radial (12.4%), or ulnar (0.1%) artery as primary access. A total of 53 VCs (0.5%) were observed: 44 (83%) radial related and 9 (17%) nonradial related. Major VCs occurred in 16 patients only (0.2%) and were radial related in 10 (62.5%) and nonradial related in 6 (37.5%) patients. Vascular complications rate was stable during the study and independent of operator's experience. Access crossover rate was 4.9%, differed according to the operator radial experience and significantly decreased over time.
CONCLUSIONS:
The present study, conducted in a center with high volume of radial procedures, shows that transradial approach is associated with a very low rate of VC, which is stable over time. On the contrary, access crossover rate decreased over time and differed according to operator (radial) experience.

2. Park BJ, Melfi F, Mussi A, Maisonneuve P, Spaggiari L, Da Silva RK, Veronesi G. Robotic lobectomy for non-small cell lung cancer (NSCLC): long-term oncologic results. J Thorac Cardiovasc Surg. 2012 Feb;143(2):383-9. Epub 2011 Nov 20.
Division of Thoracic Surgery, Hackensack University Medical Center, Hackensack, NJ 07601, USA. bpark@humed.com

Abstract
OBJECTIVE(S):
We evaluated a large series of patients undergoing robotic lobectomy for the treatment of early-stage non-small cell lung cancer (NSCLC) to assess long-term oncologic efficacy.
METHODS:
A multi-institutional retrospective review of patients undergoing robotic lobectomy for NSCLC was performed. Robotic lobectomy was performed in a manner consistent with the Cancer and Leukemia Group B (CALGB) consensus video-assisted thoracic surgery (VATS) lobectomy technique using a robotic surgical system. Perioperative outcomes and long-term follow-up were recorded prospectively, and survival was calculated from the date of surgery to last follow-up.
RESULTS:
From November 2002 through May 2010, a total of 325 consecutive patients underwent robotic lobectomy for early-stage NSCLC at 3 institutions. The median age of patients was 66 years (range, 30-87 years), and 37% (120) were female. The majority were in clinical stage I (IA, 247; IB, 63). Conversion rate to thoracotomy was 8% (27/325). Overall morbidity rate was 25.2% (82/325), and major complication rate was 3.7% (12/325). There was 1 in-hospital death (0.3%), and the median length of stay was 5 days (range, 2-28 days). Pathologic stage distribution was 54% (176) IA, 22% (72) IB, 13% (41) IIA, 5% (15) IIB, and 6% (21) IIIA. With a median follow-up of 27 months, overall 5-year survival was 80% (95% confidence intervals [CI] = 73-88), and by pathologic stage, 91% (CI = 83-99) for stage IA, 88% (CI = 77-98) for stage IB, and 49% (CI = 24-74) for all patients with stage II disease. Overall 3-year survival for patients with stage IIIA disease was 43% (CI = 16-69).
CONCLUSIONS:
Robotic lobectomy for early-stage NSCLC can be performed with low morbidity and mortality. Long-term stage-specific survival is acceptable and consistent with prior results for VATS and thoracotomy.

Commento a cura di Nerina Agabiti
L’interessante lavoro di Park et al riporta i risultati di uno studio multicentrico internazionale mirato a valutare gli esiti a lungo termine della tecnica di lobectomia “robotica” nel tumore polmonare non-a-piccole cellule (non-small cell lung cancer). Nelle ultimi anni la lobectomia “minimally invasive” eseguita con chirurgia video assistitita è stata proposta come efficace procedura per il trattamento di questo tipo di tumore negli stadi precoci, tuttavia è un tecnica complessa e sofisticata e quindi non di facile applicazione. Più recentemente è stata proposta una nuova tecnica chirurgica, la “robotic lobectomy”. Questo lavoro si propone di analizzare sia gli esiti perioperatori sia l’efficacia nel lungo periodo di tale tecnica. Si tratta di uno studio di coorte su 325 persone arruolate consecutivamente in 3 ospedali (New York, Pisa, Milano) nel periodo 2002-2010 con tumore polmonare non-a-piccole cellule stadi iniziali. Nell’8% dei casi è stato necessario proseguire l’intervento con la toracotomia. Almeno un problema clinico nel periodo post-chirurgico si è verificato nel 25% dei casi (senza differenze tra centri), ma complicanze maggiori solo nel 3.7%. La mortalità intraospeadliera è molto bassa (solo 1 caso, 0.3%), mente la sopravvivenza a 5 anni è pari all’80% (con variabilità a seconda dallo stadio clinico iniziale). Gli autori concludono che la tecnica robotica è una valida e sicura procedura per questo tipo di pazienti; essa si accompagna a bassa incidenza di problemi clinici nel periodo perioperatorio e nella mortalità a breve temine, mentre i risultati a lungo termine sono sovrapponibile a quelli della tecnica “minimally”invasive” video assistita ed alla chirurgia aperta toracotomica.

3. Argenziano G, Zalaudek I, Hofmann-Wellenhof R, Bakos RM, Bergman W, Blum A, Broganelli P, Cabo H, Caltagirone F, Catricalà C, Coppini M, Dewes L, Francia MG, Garrone A, Turk BG, Ghigliotti G, Giacomel J, Gourhant JY, Hlavin G, Kukutsch N, Lipari D, Melchionda G, Ozdemir F, Pellacani G, Pellicano R, Puig S, Scalvenzi M, Sortino-Rachou AM, Virgili AR, Kittler H. Total body skin examination for skin cancer screening in patients with focused symptoms. J Am Acad Dermatol. 2012 Feb;66(2):212-9. Epub 2011 Jul 14.
Department of Dermatology, Second University of Naples, Naples, Italy. g.argenziano@gmail.com

Abstract
BACKGROUND:
The value of total body skin examination (TBSE) for skin cancer screening is controversial.
OBJECTIVE:
We sought to determine whether TBSE could be helpful in patients with focused skin symptoms who would not otherwise have undergone TBSE.
METHODS:
In a prospective, multicenter, cross-sectional study consecutive adult patients were recruited during a period of 18 months. Physicians first inspected problem areas and uncovered areas and then performed TBSE. Equivocal lesions detected in both steps were excised or biopsied. Primary outcomes were the absolute and relative risks of missing skin cancer and the number of patients needed to examine to detect melanoma or another malignancy. A secondary outcome was the proportion of false-positive results obtained by TBSE.
RESULTS:
We examined 14,381 patients and detected 40 (0.3%) patients with melanoma and 299 (2.1%) with at least one nonmelanoma skin cancer by TBSE. In 195 (1.3%) patients equivocal lesions found by TBSE turned out to be benign. We calculated that 47 patients need to be examined by TBSE to find one skin malignancy and 400 patients to detect one melanoma. The risk of missing one malignancy if not performing TBSE was 2.17% (95% confidence interval 1.25-3.74). Factors significantly increasing the chance to find a skin cancer were age, male gender, previous nonmelanoma skin cancer, fair skin type, skin tumor as the reason for consultation, and presence of an equivocal lesion on problem/uncovered areas.
LIMITATIONS:
The impact of TBSE on skin cancer mortality was not evaluated.
CONCLUSIONS:
TBSE improves skin cancer detection in patients with focused skin symptoms and shows a low rate of false-positive results.

4. Lanza GA, Barone L, Di Monaco A. Effect of Spinal Cord Stimulation in Patients With Refractory Angina: Evidence From Observational Studies. Neuromodulation. 2012 Feb 24. doi: 10.1111/j.1525-1403.2012.00430.x. [Epub ahead of print]
Department of Cardiovascular Medicine, Università Cattolica del Sacro Cuore, Rome, Italy.

Abstract
To review the evidence in observational studies of the effect of Objectives: spinal cord stimulation (SCS) in patients with refractory angina pectoris (RAP) due to obstructive coronary artery disease. The effect of SCS in patients with refractory microvascular angina (MVA) also was assessed. Materials and Methods: We reviewed the observational studies, published from 1987 to 2010, which investigated the effects of SCS on RAP. The number of angina attacks and that of taken nitrate tablets, as well as the class of angina, were considered as main outcome variables. The occurrence of adverse events related to the treatment also The results showed a consistent reduction of the number was assessed. Results: of angina attacks (by 45-84%) and of consumption of short-acting nitrate tablets (by -75% to -94%), whereas the New York Heart Association and Canadian Cardiovascular Society class of angina were significantly improved in some studies. No case fatalities related to the therapy were reported. Significant clinical benefits were observed in some studies in patients with refractory MVA. Device-related infections and catheter dislodgment were the most significant and In observational studies, SCS frequent side-effects, respectively. Conclusions: showed to be an effective form of treatment for RAP, including refractory MVA. The treatment appears to be safe both at short- and long-term follow-up.

5. Apolone G, Deandrea S, Montanari M, Corli O, Greco MT, Cavuto S. Evaluation of the comparative analgesic effectiveness of transdermal and oral opioids in cancer patients: A propensity score analysis. Eur J Pain. 2012 Feb;16(2):229-38. doi: 10.1002/j.1532-2149.2011.00020.x. Epub 2011 Dec 19.
Direzione Scientifica, Azienda Ospedaliera 'Arcispedale Santa Maria Nuova', IRCCS, Reggio-Emilia, Italy.

Abstract
BACKGROUND:
Transdermal delivery systems containing fentanyl or buprenorphine, despite the relatively lack of comparative studies, have reached an impressive share of the market in several countries. In the context of a wider observational study, we applied the propensity score to test the comparative effectiveness of the two routes of administration (oral vs. transdermal).
METHODS:
We applied the propensity score in a subgroup of patients (starting the World Health Organization third step therapy during the scheduled follow-up of 28 days) using pre-planned primary (pain intensity change) and secondary endpoints, such as increase in doses, need for switching and safety profile. Univariate and multivariate analyses were carried out.
RESULTS:
Three-hundred sixty-six eligible cases were analysed. We found a difference among the two groups in terms of variables potentially associated with therapy choice and outcomes. After adjusting for propensity score, results were in favour of transdermal delivery systems for the primary endpoint (odds ratio 1.68; p = 0.04). A similar trend was also present for the other secondary endpoints. Only in the case of nausea and vomiting, patients receiving transdermal delivery systems reported a higher frequency of events.
CONCLUSION:
The application of the propensity score has helped understand better the actual effectiveness of transdermal delivery systems that are at least equivalent to the oral opioids, and even more effective for pain intensity reduction.

6. Pinneri F, Frea S, Najd K, Panella S, Franco E, Conti V, Corgnati G. Echocardiography-guided versus fluoroscopy-guided temporary pacing in the emergency setting: an observational study. J Cardiovasc Med (Hagerstown). 2012 Jan 11. [Epub ahead of print]
Division of Cardiology, Internal Medicine Department, Ospedale Civico di Chivasso bDivision of Cardiology, Internal Medicine Department, AOU S. Giovanni Battista 'Molinette' di Torino and University of Torino, Torino, Italy.

Abstract
BACKGROUND:
The insertion of a temporary pacemaker can be a lifesaving procedure in the emergency setting.
OBJECTIVES:
This is an observational monocentric study comparing echocardiography-guided temporary pacemaker via the right internal jugular vein to standard fluoroscopy-guided temporary pacemaker via the femoral vein; the procedure was tested for noninferiority.
METHODS:
Patients needing urgent pacing were consecutively enrolled. Primary efficacy endpoints were time to pacing and need for catheter replacement. Primary safety endpoint was a composite outcome of overall complications.
RESULTS:
One hundred and six patients (77 ± 10 years) were enrolled: 53 underwent echocardiographic-guided and 53 fluoroscopy-guided temporary pacemaker. Baseline characteristics of the two groups of treatment were similar. Time to pacing was shorter in the echocardiography-guided than in the fluoroscopy-guided group (439 ± 179 vs. 716 ± 235 s; P < 0.0001; power 100%). During the pacing (54 ± 35 h), there was a higher incidence of pacemaker malfunction in the fluoroscopy-guided group [15 vs. 3 patients; odds ratio (OR) 6.5, confidence interval (CI) 95% 1.9-29.7, P < 0.001; power 85.7%] and there was a significantly lower incidence of complications in the echocardiography-guided temporary pacemaker group (6 vs. 22 patients; OR 0.18, CI 95% 0.06-0.49, P < 0.001; echocardiography-guided temporary pacemaker events rate 0.1929 vs. fluoroscopy-guided temporary pacemaker events rate 1.398 per 100 person-hours paced, P < 0.0001). In the standard group there was one death attributable to a temporary pacemaker complication (sepsis).
CONCLUSION:
Echocardiography-guided temporary pacemaker is a well-tolerated procedure that could allow reliable insertion of a temporary pacemaker; therefore, it is a well-tolerated option in an emergency setting and in hospitals where fluoroscopy is not available.

7. Boldrini R, Fasano L, Nava S. Noninvasive mechanical ventilation. Curr Opin Crit Care. 2012 Feb;18(1):48-53.
Respiratory and Critical Care, Sant'Orsola Malpighi Hospital, Bologna, Italy.

Abstract
PURPOSE OF REVIEW:
A critical review of the most recent literature regarding use and clinical indications of noninvasive mechanical ventilation (NIV).
RECENT FINDINGS:
According to several randomized controlled trials, NIV has gained acceptance as the preferred ventilatory modality to treat acute respiratory failure (ARF) due to chronic obstructive pulmonary disease exacerbations, cardiogenic pulmonary edema, respiratory failure in immunocompromised patients, and to decrease the intubation length and to improve weaning results in patients recovering from a hypercapnic respiratory failure. Observational studies suggest that NIV may also be used to treat other conditions like severe pneumonia (including H1N1 virus), severe asthma attack, cystic fibrosis, obesity hypoventilation, and to improve the respiratory outcome in postsurgical patients.
SUMMARY:
NIV has radically changed the management of ARF. Recently the possible applications of NIV have increased, both in the hospital and extrahospital setting. NIV is no longer confined to the ICU, but has crossed over into the regular ward, Emergency Department and 'out-of-hospital' environment. Current research is focusing on improving the quality and safety of the devices and establishing new ventilatory modes in order to extend even further the indications to NIV as well as its rate of success.

Commento a cura di Nerina Agabiti
La ventilazione meccanica non invasiva è una tecnica sempre più in uso nella pratica clinica per la cura dell’insufficienza respiratoria acuta (IRA). Essa ha completamente cambiato negli ultimi anni lo scenario delle cure pera IRA sia nel settino ospedaliero sia extraospedaliero. Mentre in passato era, infatti, una prerogativa delle unità di terapia intensiva, sono sempre più frequenti esperienze di uso anche in reparti specialistici pneumologici, in dipartimenti di emergenza ed anche in ambiente ambulatoriale. Naturalmente l’uso di tale tecnica varia tra paesi e nel tempo; particolare diffusione ha avuto in Francia dove c’è stato un incremento dal 16 al 23% del totale dei trattamenti ventilatori per IRA tra il 1997 ed il 2002. Nella interessante revisione di Boldrini et al vengano illustrate le diverse applicazioni cliniche attraverso una analisi delle evidenze di letteratura degli ultimi anni provenienti sia da studi clinici randomizzati sia da studi osservazionali. L’ indicazione principale alla ventilazione meccanica non invasiva è l’IRA che può avere diverse cause: riacutizzazione della broncopneumopatia cronica ostruttiva, edema polmonare di origine cardiaco, insufficienza respiratoria in pazienti immunocompromessi. Inoltre la ventilazione meccanica non invasiva è applicata con successo nello svezzamento dei pazienti con grave insufficienza respiratoria ipercapnica o nel periodo post-intubazione endotracheale. Da studi osservazionali risulta che la ventilazione meccanica non invasiva può essere usata con successo anche in altre condizioni come forme gravi di polmonite, gravi attacchi di asma, fibrosi cistica, sindromi di ipoventilazione da obesità, e per migliorare la funzionalità respiratoria nei pazienti post-chirurgici. Sono in rapida espansione, infatti, nuove applicazioni come il periodo post-chirurgico e nella prevenzione della IRA in pazienti ad alto rischio (es_ nei grandi anziani e negli obesi). La ricerca si sta focalizzando sul miglioramento dei devices in uso per la ventilazione meccanica non invasiva e per migliorare sicurezza ed efficacia.

8. Benedetti Panici P, Perniola G, Pernice M, Antonilli M, Achilli C, Di Donato V, Bellati F. Laparoscopically guided minilaparotomy: a minimally invasive approach for the treatment of gynaecologic diseases in morbidly obese patients. Eur J Obstet Gynecol Reprod Biol. 2012 Feb;160(2):210-4. Epub 2011 Dec 2.
Department of Obstetrics and Gynaecology, University of Rome Sapienza, Via del Policlinico, 155 - 00187 Rome, Italy.

Abstract
OBJECTIVE:
Obese patients are at greater risk of gynaecologic surgery. Laparotomy is generally performed, even though this approach is regarded as highly invasive, whereas laparoscopy, though minimally invasive, is relatively contraindicated because of the high conversion rates to laparotomy. In light of this, we propose laparoscopically guided transverse minilaparotomy (LGTM) as a minimally invasive alternative technique. The rationale of diagnostic laparoscopy is to evaluate the feasibility of a minimally invasive approach. We have evaluated the feasibility and compared the outcomes with a historical group treated with laparotomy (LPTM), in morbidly obese patients (MOP) subjected to gynaecologic surgery.
STUDY DESIGN:
From November 2004, MOPs with body mass index (BMI) ≥ 40 kg/m(2) and admitted for gynaecologic surgery (early stage endometrial cancer and benign disease) were enrolled in this observational study and submitted to LGTM. Patients with a uterine size greater than the umbilical transverse line and with indication for vaginal surgery were excluded operative data and outcome were prospectively recorded.
RESULTS:
LGTM was feasible in 34 cases (87%) out of 39. In two women, the procedure was aborted due to intraperitoneal and ovarian malignant disease spread diagnosed at laparoscopy. In three cases, conversion was necessary due to severe adhesions in one case; laparoscopically unrecognized disease spread in the parametria in the second, and in the remaining case a right common iliac vein injury during lymphadenectomy. When compared to LPTM, haemoglobin drop and postoperative stay were significantly reduced with LGTM. Complications were higher in the control group: due to a significantly higher incidence of wound dehiscence (OR 0.27, 95% CI 0.05-1.32, p<0.05).
CONCLUSIONS:
LGTM is feasible in the vast majority of MOPs and achieves significantly better results when compared to the standard approach.

9. Di Nisio M, Wichers IM, Middeldorp S. Treatment for superficial thrombophlebitis of the leg. Cochrane Database Syst Rev. 2012 Mar 14;3:CD004982.
Department of Medicine and Aging; Centre for Aging Sciences (Ce.S.I.), Internal Medicine Unit, "University G. D'Annunzio" Foundation, via dei Vestini 31, Chieti, Italy, 66013.

Abstract
BACKGROUND:
The optimal treatment of superficial thrombophlebitis (ST) of the legs remains poorly defined. While improving or relieving the local painful symptoms, treatment should aim at preventing venous thromboembolism (VTE), which might complicate the natural history of ST. This is an update of a review first published in 2007.
OBJECTIVES:
To assess the efficacy and safety of topical, medical, and surgical treatments in patients presenting with ST of the legs.
SEARCH METHODS:
For this update the Cochrane Peripheral Vascular Diseases Group searched their Specialised Register (last searched 29 November 2011) and CENTRAL (2011, Issue 4). We handsearched reference lists of relevant papers and conference proceedings.
SELECTION CRITERIA:
Randomised controlled trials (RCTs) evaluating topical, medical, and surgical treatments for ST of the leg that included participants with a clinical diagnosis of ST of the legs or objective diagnosis of a thrombus in the superficial vein.
DATA COLLECTION AND ANALYSIS:
Two authors assessed the trials for inclusion in the review, extracted the data, and assessed the quality of the studies. Data were independently extracted from the included studies and any disagreements resolved by consensus.
MAIN RESULTS:
Twenty-six studies involving 5521 participants with ST of the legs were included in this review. The methodological quality of most of the trials was poor. Treatment ranged from fondaparinux, low molecular weight heparin (LMWH), unfractionated heparin (UFH), non-steroidal anti-inflammatory agents (NSAIDs), topical treatment, oral treatment, intramuscular treatment, and intravenous treatment to surgery. In a placebo-controlled RCT of about 3000 patients, fondaparinux was associated with a significant reduction in symptomatic VTE (RR 0.15; 95% CI 0.04 to 0.50), extension (RR 0.08; 95% CI 0.03 to 0.22), and recurrence of ST (RR 0.21; 95% CI 0.08 to 0.54) with comparable rates of major bleeding (RR 0.99; 95% CI 0.06 to 15.86) relative to placebo. Both prophylactic and therapeutic doses of LMWH (RR 0.40; 95% CI 0.22 to 0.72 and RR 0.42; 95% CI 0.23 to 0.75, respectively) and NSAIDs (RR 0.41; 95% CI 0.23 to 0.75) reduced the extension and recurrence of ST in comparison to placebo, with no significant effects on symptomatic VTE nor major bleeding. Overall, topical treatments improved local symptoms. However, no data were provided on the effects of these treatments on VTE and ST extension. Surgical treatment combined with elastic stockings in ST was associated with a lower VTE rate and ST progression compared with elastic stockings alone.
AUTHORS' CONCLUSIONS:
Prophylactic dose fondaparinux given for six weeks appears to be a valid therapeutic option for ST of the legs. Further research is needed to assess the role of new oral direct thrombin and activated factor-X inhibitors, LMWH, NSAIDs; the optimal doses and duration of treatment; and whether a combination therapy may be more effective than single treatment. Adequately designed and conducted studies are required to clarify the role of topical and surgical treatments.

10. Taccetti G, Bianchini E, Cariani L, Buzzetti R, Costantini D, Trevisan F, Zavataro L, Campana S; on behalf of the Italian Group for P aeruginosa eradication in cystic fibrosis. Early antibiotic treatment for Pseudomonas aeruginosa eradication in patients with cystic fibrosis: a randomised multicentre study comparing two different protocols. Thorax. 2012 Feb 29. [Epub ahead of print]
Department of Sciences for Woman and Child's Health, University of Florence, Cystic Fibrosis Centre, Anna Meyer Children's University Hospital, Florence, Italy.

Abstract
BACKGROUND:
Pseudomonas aeruginosa chronic pulmonary infection is an unfavourable event in cystic fibrosis. Bacterial clearance is possible with an early antibiotic treatment upon pathogen isolation. Currently, no best practice exists for early treatment. The efficacy of two different regimens against initial P aeruginosa infection was assessed.
METHODS:
In a randomised, open-label, parallel-group study involving 13 centres, the superiority of inhaled tobramycin/oral ciprofloxacin compared with inhaled colistin/oral ciprofloxacin (reference treatment) over 28 days was evaluated. Patients were eligible if they were older than 1 year with first or new P aeruginosa isolation. Treatments were assigned equally by centralised balanced randomisation, stratified by age and forced expiratory volume in 1 s values. The participants and those giving the intervention were not masked to arm assignments. The primary endpoint was P aeruginosa eradication, defined as three successive negative cultures in 6 months. Analysis was by intention to treat. This trial was registered with EudraCT, number 2008-006502-42.
RESULTS:
105 patients were assigned to inhaled colistin/oral ciprofloxacin (arm A) and 118 to inhaled tobramycin/oral ciprofloxacin (arm B). All patients were analysed. P aeruginosa was eradicated in 66 (62.8%) patients in arm A and in 77 (65.2%) in arm B (OR 0.90, 95% CI 0.52 to 1.55, p=0.81). Following treatment, an increase in Stenotrophomonas maltophilia was noted (OR 3.97, 95% CI 2.27 to 6.94, p=0.001) with no differences between the two arms (OR 0.89, 95% CI 0.44 to 1.78, p=0.88).
CONCLUSIONS:
No superiority of treatment under study was demonstrated in comparison to the reference treatment. Early eradication treatment was associated with an increase in S maltophilia.

11. Tamburino C, Barbanti M, Capodanno D, Mignosa C, Gentile M, Aruta P, Pistritto AM, Bonanno C, Bonura S, Cadoni A, Gulino S, Di Pasqua MC, Cammalleri V, Scarabelli M, Mulè M, Immè S, Campo GD, Ussia GP. Comparison of Complications and Outcomes to One Year of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis. Am J Cardiol. 2012 Feb 20. [Epub ahead of print]
Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy; Excellence Through Newest Advances (ETNA) Foundation, Catania, Italy.

Abstract
Comparisons of transcatheter aortic valve implantation (TAVI) to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis remain sparse or limited by a short follow-up. We sought to evaluate early and midterm outcomes of consecutive patients (n = 618) undergoing successful TAVI (n = 218) or isolated SAVR (n = 400) at 2 centers. The primary end point was incidence of Valvular Academic Research Consortium-defined major adverse cerebrovascular and cardiac events (MACCEs) up to 1 year. Control of potential confounders was attempted with extensive statistical adjustment by covariates and/or propensity score. In-hospital MACCEs occurred in 73 patients (11.8%) and was more frequent in patients treated with SAVR compared to those treated with TAVI (7.8% vs 14.0%, p = 0.022). After addressing potential confounders using 3 methods of statistical adjustment, SAVR was consistently associated with a higher risk of MACCEs than TAVI, with estimates of relative risk ranging from 2.2 to 2.6 at 30 days, 2.3 to 2.5 at 6 months, and 2.0 to 2.2 at 12 months. This difference was driven by an adjusted increased risk of life-threatening bleeding at 6 and 12 months and stroke at 12 months with SAVR. Conversely, no differences in adjusted risk of death, stroke and myocardial infarction were noted between TAVI and SAVR at each time point. In conclusion, in a large observational registry with admitted potential for selection bias and residual confounding, TAVI was not associated with a higher risk of 1-year MACCEs compared to SAVR.

12. Trastulli S, Cirocchi R, Listorti C, Cavaliere D, Avenia N, Gullà N, Giustozzi G, Sciannameo F, Noya G, Boselli C. Laparoscopic versus open resection for rectal cancer: a meta-analysis of randomized clinical trials. Colorectal Dis. 2012 Feb 13. doi: 10.1111/j.1463-1318.2012.02985.x. [Epub ahead of print]
Department of General Surgery, S. Maria Hospital, University of Perugia, Terni, Italy Department of General and Oncologic Surgery, University of Perugia, Perugia, Italy Unit of Surgery and Advanced Oncologic Therapies, Forlì Hospital, Forlì, Italy.

Abstract
Laparoscopic and open rectal resection for cancer were compared analyzing a Aim: total of 26 end points which included intraoperative and postoperative recovery, short-term morbidity and mortality, late morbidity and long term oncologic We searched for published randomized clinical trials, outcome. Methods: presenting a comparison between laparoscopic and open rectal resection for cancer by using the following electronic databases: Pub Med, OVID Medline, Cochrane Nine database of systematic reviews, EBM reviews, CINAHL and EMBASE. Results: randomized clinical trials (RCT) were included in the meta-analysis incorporating 1,544 patients with 841 having laparoscopic 703 open rectal resection for cancer. Laparoscopic surgery for rectal cancer was associated with a statistically significant reduction in intraoperative blood loss and in the number of blood transfusions, earlier return of bowel function and a shorter duration of hospital stay. We also found a significant advantage for laparoscopy in the reduction of wound infection, post-operative intra abdominal bleeding, late intestinal adhesion obstruction and in the late morbidity. No differences were found in The terms of intra-operative and late oncologic outcomes. Conclusion: metanalysis indicates that laparoscopy benefits patients, with shorter hospital stay, earlier return of bowel function, reduced blood loss, number of blood transfusion and lower rates of wound infection, intra-abdominal postoperative bleeding, late intestinal adhesion obstruction and other late morbidity.

13. Fossaceca R, Guzzardi G, Di Terlizzi M, Divenuto I, Malatesta E, Cerini P, Cusaro C, Carriero A. Comparison of cryoplasty and conventional angioplasty for treating stenotic-occlusive lesions of the femoropopliteal arteries in diabetic patients: immediate, mid-term and long-term results. Radiol Med. 2012 Feb 10. [Epub ahead of print]
S.C.D.U Radiodiagnostica e Radiologia Interventistica, A.O.U. Maggiore della Carità, C.so Mazzini 18, 28100, Novara, Italy, rfossaceca@hotmail.com.

Abstract
PURPOSE:
The authors compared the immediate, mid-term and long-term effectiveness of cryoplasty and conventional angioplasty for treating stenotic-occlusive lesions of the femoropopliteal arteries in diabetic patients. MATERIALS AND
METHODS:
From October 2006 to November 2009, 48 patients with non-insulin-dependent diabetes mellitus (DM) and an indication for percutaneous revascularisation of the femoropopliteal arteries were randomly assigned to treatment with angioplasty or cryoplasty. The following parameters were analysed and compared between the two groups: immediate technical success (residual stenosis <30%) and distal run-off as assessed on postprocedural angiography, and degree of restenosis and distal run-off at 6 and 12 months, as assessed with either colour Doppler ultrasound (CDUS) or digital subtraction angiography (DSA).
RESULTS:
Treatment with angioplasty revealed a significant superiority in procedural technical success (p=0.04), a significant reduction in the degree of restenosis at 6 months (p=0.02) and a significant increase in the distal run-off at 6 (p=0.005) and 12 (p=0.01) months.
CONCLUSIONS:
Conventional angioplasty is more effective than cryoplasty for treating stenotic-occlusive lesions of the femoropopliteal arteries in diabetic patients and provides better immediate, mid-term and long-term results.

14. Cabrini L, Monti G, Landoni G, Biondi-Zoccai G, Boroli F, Mamo D, Plumari VP, Colombo S, Zangrillo A. Percutaneous tracheostomy, a systematic review. Acta Anaesthesiol Scand. 2012 Mar;56(3):270-81. doi: 10.1111/j.1399-6576.2011.02592.x. Epub 2011 Dec 20.
University Vita-Salute San Raffaele, Milano, Italy.

Abstract
BACKGROUND:
Percutaneous dilatational tracheostomy (PDT) is a common procedure in intensive care units and the identification of the best technique is very important. We performed a systematic review and meta-analysis of randomized studies comparing different PDT techniques in critically ill adult patients to investigate if one technique is superior to the others with regard to major and minor intraprocedural complications.
METHODS:
BioMedCentral and other database of clinical trials were searched for pertinent studies. Inclusion criterion was random allocation to at least two PDT techniques. Exclusion criteria were duplicate publications, nonadult studies, and absence of outcome data.
STUDY DESIGN:
Population, clinical setting, and complications were extracted.
RESULTS:
Data from 1130 patients in 13 randomized trials were analyzed. Multiple dilators, single-step dilatation, guide wire dilating forceps, rotational dilation, retrograde tracheostomy, and balloon dilation techniques were always performed in the intensive care unit. The different techniques and devices appeared largely equivalent, with the exception of retrograde tracheostomy, which was associated with more severe complications and more frequent need of conversion to other techniques when compared with guide wire dilating forceps and single-step dilatation techniques. Single-step dilatation technique was associated with fewer failures than rotational dilation, and fewer mild complications in comparison with balloon dilation and guide wire dilating forceps (all P < 0.05).
CONCLUSIONS:
Among the six analyzed techniques, single-step dilatation technique appeared the most reliable in terms of safety and success rate. However, the number of available randomized trials was insufficient to confidently assess the best PDT technique.

15. Ruzzenente A, Guglielmi A, Sandri M, Campagnaro T, Valdegamberi A, Conci S,Bagante F, Turcato G, D'Onofrio M, Iacono C. Surgical resection versus local ablation for HCC on cirrhosis: results from a propensity case-matched study. J Gastrointest Surg. 2012 Feb;16(2):301-11; discussion 311. Epub 2011 Nov 18.
General Surgery A, Department of Surgery, University of Verona, Verona, Italy. andrea.ruzzenente@fastwebnet.it

Abstract
BACKGROUND:
Surgery for hepatocellular carcinoma (HCC) had great improvements in the last decades with low morbidity and mortality and good long-term results. Percutaneous local ablative therapies (LAT) such as radiofrequency ablation and ethanol injection (PEI) for HCC gained consent for their efficacy and safety. In retrospective studies, patients submitted to resection (LR) or LAT frequently have important selection bias. Propensity case-matched analysis proved to reduce selection bias of retrospective studies and allow comparison between different therapies.
AIM:
The aim of this study was to evaluate survival comparing LR and LAT in two groups of cirrhotic patients with HCC matched with propensity score methods.
METHODS:
Four hundred and seventy-eight cirrhotic patients with HCC treated with LR or LAT with curative intent between January 1995 and December 2009 were included in the study. One hundred and eighty-one patients underwent LR, and 297 patients were treated with LAT. Tumor stage and liver function were evaluated in all patients. To balance the covariates in the two groups, a one-to-one propensity case-matched analysis was used. A multivariable logistic model based on age, gender, etiology of cirrhosis, Child-Pugh class, number of nodules, maximum diameter of nodules, and serum alpha-fetoprotein level was used to estimate propensity score. One-to-one caliper matching of LR and LAT groups was performed, generating a matched sample of 176 patients with 88 patients in each group.
RESULTS:
Median survival was 65.1 months (95% CI = 48.5-81.7) after LR and 37.3 months (95% CI = 29.3-45.3) after LAT (p = 0.008). For patients in Child-Pugh class A with single HCC and maximum diameter <5 cm, median survival was 65.0 months (95% CI = 58.4-71.6) for the LR group and 63.7 months (95% CI = 31.8-95.7) for the LAT group (p = 0.730). For patients in Child-Pugh class A with single HCC and diameter ≥5 cm, median survival was 79.9 months (95% CI = 40.1-119.8) for the LR group and 21.5 months (95% CI = 10.8-32.1) for the LAT group (p = 0.023). For patients in Child-Pugh class A with two to three nodules and maximum diameter ≤3 cm, mean survival was 69.3 months (95% CI 48.7-89.9) for the LR group and 45.7 months (95% CI = 22.8-68.7) for the LAT group (p = 0.168). For patients in Child-Pugh class A with two to three nodules and diameter >3 cm, median survival was 82.9 months (95% CI = 52.0-113.7) for the LR group and 18.9 months (95% CI = 6.3-31.4) for the LAT group (p = 0.001).
CONCLUSION:
Our propensity case-matched study confirmed that survival is similar after LR and LAT for single HCC smaller than 5 cm and for oligofocal HCC (up to three nodules) smaller than 3 cm; instead, for HCC larger than 5 cm or oligofocal HCC (up to three nodules) larger than 3 cm, surgical resection improves significantly long-term survival.

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