Nystagmus intensity and direction in bow and lean test: An aid to diagnosis of lateral semicircular canal benign paroxysmal positional vertigo [Intensità e direzione del nistagmo nel “bow and lean test”: Un contributo alla diagnosi nella vertigine parossistica da posizionamento benigna del canale semicircolare laterale]
Marcelli V.,University of Naples Federico II |
Marcelli V.,San Giovanni Bosco Hospital
Acta Otorhinolaryngologica Italica | Year: 2016
The objective was to evaluate nystagmus intensity and direction (NID) during bow and lean test (BLT) in subjects suffering from idiopathic lateral semicircular canal benign paroxysmal positional vertigo (LSC-BPPV), in order to differentiate between the geotropic and the apogeotropic form and to determine the affected ear before using classic diagnostic procedures. The BLT was performed in 32 subjects affected by LSC-BPPV. “Nystagmus intensity” evaluation allows distinguishing the geotropic variant from the apogeotropic one, while the “nystagmus direction” allows identification of the side. In particular, a more intense nystagmus in the bow position compared to the lean position indicates an ampullipetal flow caused by the presence of free-floating particles in the non-ampullary arm, and is suggestive of geotropic form. In this case, if the nystagmus in the bow position is left beating, the free-floating particles necessarily occupy the left LSC non-ampullary arm, while a right-beating nystagmus indicates the right LSC involvement. In contrast, a more intense nystagmus in the lean position compared to the bow position indicates an ampullifugal flow due to the presence of particles adherent to the cupula (cupulolithiasis) or free-floating in the ampullary arm (canalolithiasis), suggesting an apogeotropic form. In this situation, if the nystagmus in the lean position is left beating, the particles are in the left LSC ampullar arm or are coated on the left LSC cupula; vice versa, a right-beating nystagmus in the lean position is suggestive of the involvement of the right LSC. As a general rule, in both forms the direction of the more intense nystagmus points to the affected side. “NID-BLT” was effective in identifying the form and the side in 22/28 subjects (79% of the study population). The proper execution and interpretation of the “NID-BLT” helps to establish the form (geotropic versus apogeotropic) and side (right versus left) in most cases of LSC-BPPV. Unlike Choung’s test, which requires knowing a priori if the form is geotropic or apogeotropic, our test enables fast and accurate diagnosis, or at least provides indispensable elements if the diagnosis of the affected side is doubtful, with the patient remaining in the sitting position. © 2016, Pacini Editore S.p.A. All rights reserved.
Simone G.,Regina Elena Cancer Institute |
Simone G.,San Giovanni Bosco Hospital |
Gill I.S.,University of Southern California |
Mottrie A.,OLV Vattikuti Robotic Surgery Institute |
And 4 more authors.
European Urology | Year: 2015
Context On-clamp partial nephrectomy (PN) has been considered the standard approach to minimize intraoperative bleeding and thus achieve adequate control of tumor margins. The potential negative impact of ischemia on renal function (RF) led to the development of techniques to minimize or avoid renal ischemia, such as off-clamp PN and minimally ischemic PN techniques. Objective To review current evidence on the indications and techniques for and outcomes of minimally ischemic and off-clamp PN. Evidence acquisition A systematic review of English-language publications on PN without a main renal artery clamp from January 2005 to July 2014 was performed using the Medline, Embase, and Web of Science databases. Evidence synthesis The searches retrieved 52 papers. Off-clamp PN has been more commonly applied to small and peripheral renal tumors, while minimally ischemic PN is best suited for hilar and medially located renal tumors. These approaches are associated with increased intraoperative blood loss and perioperative transfusion rates compared to on-clamp PN. Minimally ischemic and off-clamp PN have potential functional benefits when longer ischemia time is anticipated, particularly for patients with lower baseline RF. Limitations include the lack of prospective randomized trials comparing minimally ischemic and off-clamp to on-clamp techniques, and the small sample size and short follow-up of most published series. The impact of different resection and renorrhaphy techniques on postoperative RF and its assessment via renal scintigraphy requires further investigations. Conclusions Minimally ischemic and off-clamp PN are established procedures that may be particularly applicable for patients with decreased baseline RF. However, these techniques are technically demanding, with potential for increased blood loss, and require considerable experience with PN surgery. The role of ischemia in patients with a contralateral healthy kidney and consequently an indication for elective minimally ischemic or off-clamp PN remains a debatable issue. Patient summary In this review we analyzed available evidence on minimally ischemic and off-clamp partial nephrectomy. These techniques, although technically demanding, may be particularly applicable for patients with decreased baseline renal function. © 2015 European Association of Urology.
Busetto L.,University of Padua |
Dixon J.,Baker IDI Heart and Diabetes Institute |
De Luca M.,San Bortolo Hospital |
Shikora S.,Brigham and Women's Hospital |
And 3 more authors.
Obesity Surgery | Year: 2014
Class I obesity conveys an increased risk of comorbidities, impairs physical and mental health-related quality of life, and it is associated to an increased psychosocial burden, particularly in women. The need for effective and safe therapies for class I obesity is great and not yet met by nonsurgical approaches. Eligibility to bariatric surgery has been largely based on body mass index (BMI) cut points and limited to patients with more severe obesity levels. However, obese patients belonging to the same BMI class may have very different levels of health, risk, and impact of obesity on quality of life. Individual patients in class I obesity may have a comorbidity burden similar to, or greater than, patients with more severe obesity. Therefore, the denial of bariatric surgery to a patient with class I obesity suffering from a significant obesity-related health burden and not achieving weight control with nonsurgical therapy simply on the basis of the BMI level does not appear to be clinically justified. A clinical decision should be based on a more comprehensive evaluation of the patient's current global health and on a more reliable prediction of future morbidity and mortality. After a careful review of available data about safety and efficacy of bariatric surgery in patients with class I obesity, this panel reached a consensus on ten clinical recommendations. © 2014 Springer Science+Business Media New York.
Adjuvant chemotherapy with cisplatin and gemcitabine versus chemotherapy at relapse in patients with muscle-invasive bladder cancer submitted to radical cystectomy: An italian, multicenter, randomized phase iii trial
Cognetti F.,Regina Elena Cancer Institute |
Ruggeri E.M.,Belcolle Hospital |
Felici A.,Regina Elena Cancer Institute |
Gallucci M.,Regina Elena Cancer Institute |
And 6 more authors.
Annals of Oncology | Year: 2012
Background: The purpose of the study was to evaluate the benefit of adjuvant chemotherapy (AC) versus surgery alone in patients with muscle-invasive bladder cancer (MIBC). Patients and methods: One hundred and ninety-four patients with pT2G3, pT3-4, N0-2 transitional cell bladder carcinoma were randomly allocated to control (92 patients) or to four courses of AC (102 patients). These latter patients were further randomly assigned to receive gemcitabine 1000 mg/m 2 days 1, 8 and 15 and cisplatin 70 mg/m 2 day 2 or gemcitabine as above plus cisplatin 70 mg/m 2 day 15, every 28 days. Results: At a median follow-up of 35 months, the 5-year overall survival (OS) was 48.5%, with no difference between the two arms [P = 0.24, hazard ratio (HR) 1.29, 95% confidence interval (CI) 0.84-1.99]. Mortality hazard was significantly correlated with Nodes (N) and Tumor (T) stage. The control and AC arms had comparable disease-free survival (42.3% and 37.2%, respectively; P = 0.70, HR 1.08, 95% CI 0.73-1.59). Only 62% of patients received the planned cycles. A significant higher incidence of thrombocytopenia was observed in patients receiving cisplatin on day 2 (P = 0.006). A similar global quality of life was observed in the two arms. Conclusion: The study was underpowered to demonstrate that AC with cisplatin and gemcitabine improves OS and disease-free survival in patients with MIBC. © The Author 2011. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
Franchini M.,Carlo Poma Hospital |
Coppola A.,University of Naples Federico II |
Rocino A.,San Giovanni Bosco Hospital |
Santagostino E.,Maggiore Hospital Policlinico |
And 3 more authors.
Seminars in Thrombosis and Hemostasis | Year: 2013
Nowadays, patients with hemophilia A receive a high standard of care; therefore, the most challenging complication of factor VIII (FVIII) replacement therapy has become the development of FVIII inhibitors, which render the concentrate infusion ineffective and expose patients to an increased risk of morbidity and mortality. Among environmental risk factors influencing inhibitor development, the type of FVIII products has always drawn the attention of investigators. Conflicting results are reported in the literature concerning rates of inhibitor development after either plasma-derived or recombinant FVIII concentrates. To help elucidate this controversial issue, we have performed a systematic review and meta-analysis of prospective studies evaluating the incidence of inhibitors in previously untreated patients with severe hemophilia A receiving plasma-derived or recombinant FVIII products. The quality of the studies was assessed using the Newcastle-Ottawa Scale (NOS), the STrenghtening the Reporting of OBservational studies in Epidemiology and an ad hoc quality score. Overall, 28 prospective studies, including 1,421 patients with hemophilia A, fulfilled our selection criteria and were included in the systematic review. No statistically significant differences were observed in the inhibitor incidence between plasma-derived and recombinant FVIII concentrates considering all (weighted means: 23%, 95% CI: 15-33% vs. 29%, 95% CI: 26-32%) and high titer (16%, 95% CI: 10-26% vs. 18%, 95% CI: 15-21%) inhibitors. Similarly, no significant differences were found in the inhibitor incidence among the different classes of recombinant products. In conclusion, the results of our meta-analysis show that the different types of FVIII products are not associated with different risks of inhibitor development. Copyright © 2013 by Thieme Medical Publishers, Inc.
Santonicola A.,University of Naples Federico II |
Angrisani L.,San Giovanni Bosco Hospital |
Cutolo P.,San Giovanni Bosco Hospital |
Formisano G.,San Giovanni Bosco Hospital |
Iovino P.,University of Salerno
Surgery for Obesity and Related Diseases | Year: 2014
Background Obesity is an independent risk factor for gastroesophageal reflux disease (GERD), which is often associated with the presence of a hiatal hernia (HH). Despite increasing popularity of laparoscopic sleeve gastrectomy (LSG) in bariatric surgery, its effect on GERD is still unclear. The objective of this study was to evaluate the effect of LSG with or without hiatal hernia repair (HHR) on GERD in obese patients. Methods Seventy-eight patients with HH underwent LSG with concomitant HHR (LSG+HHR group). Their data were compared with that of 102 patients without HH, who underwent only LSG (LSG-group). All patients underwent a standardized questionnaire, a double-contrast barium swallow, and an upper-gastrointestinal endoscopy before the surgical procedure and at least 6 months later. Results At baseline, the prevalence of GERD symptoms and their frequency-intensity scores did not differ between groups. At follow up, there was a significant decrease in the prevalence of typical GERD symptoms only in the LSG-group (P =.003). LSG+HHR patients showed a significantly higher heartburn frequency-intensity score compared with LSG patients (P =.009). Conclusion This finding confirms that LSG has a beneficial effect on relieving GERD symptoms, although the underlying mechanisms are still unclear; conversely, the procedure of HHR did not produce any improvement in GERD symptoms. © 2014 American Society for Bariatric Surgery.
Colombo A.,San Raffaele Scientific Institute |
Chieffo A.,San Raffaele Scientific Institute |
Frasheri A.,ASL Trapani P.O |
Garbo R.,San Giovanni Bosco Hospital |
And 11 more authors.
Journal of the American College of Cardiology | Year: 2014
BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) following second-generation drug-eluting stent (DES) implantation is still debated. OBJECTIVES The aim of this study was to test the noninferiority of 6 versus 12 months of DAPT in patients undergoing percutaneous coronary intervention with second-generation DES. METHODS: The SECURITY (Second Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy) trial was a 1:1 randomized, multicenter, international, investigator-driven, noninferiority study conducted from July 2009 to June 2014. Patients with a stable or unstable angina diagnosis or documented silent ischemia undergoing revascularization with at least 1 second-generation DES were eligible. The primary endpoint was a composite of cardiac death, myocardial infarction (MI), stroke, definite or probable stent thrombosis, or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 12 months. The main secondary endpoint was a composite of cardiac death, MI, stroke, definite or probable stent thrombosis, or BARC type 2, 3, or 5 bleeding at 12 and 24 months. RESULTS: Overall, 1,399 patients were enrolled in the study and randomized to receive 6 months (n = 682) versus 12 months (n = 717) DAPT. The primary composite endpoint occurred, respectively, in 4.5% versus 3.7% (risk difference 0.8%; 95% confidence interval [CI]: -2.4% to 1.7%; p = 0.469) at 12 months. The upper 95% CI limit was lower than the pre-set margin of 2%, confirming the noninferiority hypothesis (p < 0.05). Moreover, no differences were observed in the occurrence of the secondary endpoint at 12 months (5.3% vs. 4.0%, difference: 1.2%; 95% CI: -1.0 to 3.4; p = 0.273) and between 12 and 24 months (1.5% vs. 2.2%, difference: -0.7%; 95% CI: -2.1 to 0.6; p = 0.289). Finally, no differences were observed in de finite or probable stent thrombosis at 12 months (0.3% vs. 0.4%; difference: -0.1%; 95% CI: -0.7 to 0.4; p = 0.694) and between 12 and 24 months of follow-up (0.1% vs. 0%; difference: 0.1%; 95% CI: -0.1 to 0.4; p = 0.305). CONCLUSIONS: In a low-risk population, the noninferiority hypothesis of 6 vs. 12 months DAPT following secondgeneration DES implantation appears accepted for the incidence of cardiac death, MI, stroke, de finite/probable stent thrombosis, and BARC type 3 or 5 bleeding at 12 months. (Second Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy; NCT00944333). © 2014 by the American College of Cardiology Foundation.
Franchini M.,Carlo Poma Hospital |
Coppola A.,University of Naples Federico II |
Rocino A.,San Giovanni Bosco Hospital |
Zanon E.,University of Padua |
Morfini M.,Agency for Haemophilia
Haemophilia | Year: 2014
Despite great advances in haemophilia care in the last 20 years, a number of questions on haemophilia therapy remain unanswered. These debated issues primarily involve the choice of the product type (plasma-derived vs. recombinant) for patients with different characteristics: specifically, if they were infected by blood-borne virus infections, and if they bear high or low risk of inhibitor development. In addition, the most appropriate treatment regimen in non-inhibitor and inhibitor patients compel physicians operating at the haemophilia treatment centres (HTCs) to take important therapeutic decisions, which are often based on their personal clinical experience rather than on evidence-based recommendations from published literature data. To know the opinion on the most controversial aspects in haemophilia care of Italian expert physicians, who are responsible for common clinical practice and therapeutic decisions, we have conducted a survey among the Directors of HTCs affiliated to the Italian Association of Haemophilia Centres (AICE). A questionnaire, consisting of 19 questions covering the most important topics related to haemophilia treatment, was sent to the Directors of all 52 Italian HTCs. Forty Directors out of 52 (76.9%) responded, accounting for the large majority of HTCs affiliated to the AICE throughout Italy. The results of this survey provide for the first time a picture of the attitudes towards clotting factor concentrate use and product selection of clinicians working at Italian HTCs. © 2014 John Wiley & Sons Ltd.
Mancuso M.E.,Angelo Bianchi Bonomi Hemophilia and Thrombosis Center |
Mannucci P.M.,University of Milan |
Rocino A.,San Giovanni Bosco Hospital |
Garagiola I.,Angelo Bianchi Bonomi Hemophilia and Thrombosis Center |
And 2 more authors.
Journal of Thrombosis and Haemostasis | Year: 2012
Background: Inhibitor development is influenced by several factors and the type of factor VIII (FVIII) products may play a role. Objectives: In order to explore such a role, we designed a cohort study whose novelty resides in the classification of products not only according to the source of FVIII (plasmatic, pd, or recombinant, r) but also to their degree of purity (expressed as specific activity). Patients/Methods: Treatment data up to inhibitor development or 150 exposure days were collected in 377 patients with hemophilia A. Results: Inhibitors developed in 111 patients (29%; 96 high-responders, 25%). The cumulative incidence was progressively higher from patients treated with low/intermediate-purity pdFVIII compared with those treated with high-purity pd and rFVIII. The adjusted hazard ratio of inhibitor development was 4.9 with rFVIII and 2.0 with high-purity pdFVIII (95% CI, 2.9-8.3 and 1.1-4.0), taking as reference low/intermediate-purity pdFVIII. There was no difference in the frequency of inhibitor testing between treatment groups. Sensitivity analyses (in patients who never switched product type, previously untreated patients, those treated on-demand and those with high-risk F8 mutations) confirmed an increased inhibitor risk with rFVIII and high-purity pdFVIII. Conclusions: This study shows that the degree of purity of FVIII products influences inhibitor development independently from other risk factors, and emphasizes that differences exist within pdFVIII products. © 2012 International Society on Thrombosis and Haemostasis.
Bazzan M.,San Giovanni Bosco Hospital |
Vaccarino A.,San Giovanni Bosco Hospital |
Marletto F.,San Giovanni Bosco Hospital
Thrombosis Journal | Year: 2015
Systemic Lupus Erythematosus (SLE) is an acquired, multiorgan, autoimmune disease. Clinical presentation is extremely variable and heterogeneous. It has been shown that SLE itself is an independent risk factor for developing both arterial and venous thrombotic events since SLE patients have an Odds Ratio (OR) for thrombosis that varies depending on the clinical and laboratory characteristics of each study cohort. The risk of developing a thrombotic event is higher in this setting than in the general population and may further increase when associated with other risk factors, or in the presence of inherited or acquired pro-thrombotic abnormalities, or trigger events. In particular, a striking increase in the number of thrombotic events was observed when SLE was associated with antiphospholipid antibodies (aPL). The presence of aPLs has been described in about 50% of SLE patients, while about 20% of antiphospholipid syndrome (APS) patients have SLE. While APS patients (with or without an autoimmune disease) have been widely studied in the last years, fewer studies are available for SLE patients and thrombosis in the absence of APS. Although the available literature undoubtedly shows that SLE patients have a greater prevalence of thrombotic events as compared to healthy subjects, it is difficult to obtain a definite result from these studies because in some cases the study cohort was too small, in others it is due to the varied characteristics of the study population, or because of the different (and very copious) laboratory assays and methods that were used. When an SLE patient develops a thrombotic event, it is of great clinical relevance since it is potentially life-threatening. Moreover, it worsens the quality of life and is a clinical challenge for the clinician. © 2015 Bazzan et al.; licensee BioMed Central.