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To compare the clinical and radiographic conditions and the expression of pro-inflammatory cytokines in peri-implant crevicular fluid (PICF) at two-piece/bone level (TP/BL) versus one-piece/tissue level (OP/TL) single implants with a laser-microgrooved collar after at least 5 years of loading.In total, 20 single TP/BL implants and 20 contralateral OP/TL implants, both with a laser-microgrooved collar surface, in 20 systemically and periodontally healthy subjects (12 males and 8 females, between the age of 36 and 64 [mean age of 49.7 ± 12.3 years]), were examined. Levels of IL-1β, IL-1RA, IL-6, IL-8, IL-17, b-FGF, G-CSF, GM-CSF, IFN, MIP-1β, TNF-α, and VEGF were assessed in PICF using the Bio-Plex 200 Suspension Array System. Plaque index (PI), probing depth (PD), bleeding on probing (BOP), and gingival recession (REC) were recorded. Radiographic crestal bone levels (CBL) were assessed at the mesial and distal aspects of the implant sites.The mean PI, PD, BOP, and REC values had no significant differences in either group. A higher mean value of CBL with statistical difference was detected for TP/BL compared with OP/TL implants. The levels of IL-1β, IL-6, IL-8, GM-CSF, and MIP-1β and TNF-α were higher at TP/BL implants than at OP/TL implants. However, only IL-1β, IL-6, and TNF-α values presented significant differences between the groups.Although after 5 years of loading single TP/BL and OP/TL implants with a laser-microgrooved collar surface presented similar good clinical conditions, a higher proinflammatory state and higher crestal bone loss were detected for TP/BL implants.

Background and aims To investigate diabetes treatment initiation and continuation in the next sixth months in newly diagnosed Italian subjects. Methods and results We analyzed administrative claims of 11,300,750 Italian residents. Subjects with incident diabetes were identified by glucose lowering drug prescriptions, disease-specific co-payment exemptions and hospital discharge codes occurring in 2018 but not in 2017. Incident cases were 65,932 of whom 91.4% received the prescription of a glucose lowering drug. Among the latter, those receiving a prescription of a noninsulin medication but no insulin were 84.8%, those receiving a prescription of insulin only were 9.4%, and those receiving prescriptions of both insulin and noninsulin drugs were 5.8%. Metformin was the most frequently drug initially prescribed in noninsulin treated subjects (~85%) and sulphonylurea receptor (SUR) agonists collectively ranked as second (~13%). Lispro (35%) and glargine (34%) were the most frequently prescribed molecules in subjects who were insulin treated. Differences in prescriptions were found in age categories, with increased use of SUR agonists across decades. In the first six months, as many as 50% of noninsulin treated patients continued with the initial drug, ~15% added a second agent, ~5% switched to another medication, and ~30% discontinued any glucose lowering treatment. Conclusions These data document that current guidelines are often neglected because prescriptions of SUR agonists as first agent are still quite common and insulin is prescribed more than expected. They point out the urgent need to improve the dissemination and implementations of guidelines in diabetes care.

ObjectivesGuidelines recommend open bypass surgery for long occlusions of infrainguinal arteries. In situ saphenous vein bypass is a standardized technique. The aim of this study was to report preliminary six-month outcomes of a national, multicenter, observational, prospective registry based on the examination of treatment of critical Limb IscheMia with infragenicular Bypass adopting the in situ SAphenous VEin technique (LIMBSAVE).MethodsFrom January 2018 until October 2019, 428 patients from 41 centers were enrolled in the LIMBSAVE registry. Data were prospectively collected in a dedicated database, including demographics, preoperative risk factors, clinical and diagnostic preoperative assessments, intraoperative measures (including safety and effectiveness of the valvulotome during the surgical procedures), and 30-day follow-up data. Furthermore, estimated six-month outcomes according to Kaplan–Meier curves in terms of primary patency, primary assisted patency, secondary patency, and limb salvage were evaluated.ResultsPatients were predominantly male ( n = 332, 77.6%) with a mean age of 73.3 years (range 39–95). Technical success, defined as bypass pulse after use of the valvulotome, was obtained in all cases. The proximal anastomosis could be reached by the valvulotome in all cases. The mean number of valvulotome uses was 2.5 (range 1–5). No vein perforation was reported. In nine cases (2.1%), a vein lesion with intramural hemorrhage occurred. The mean length of hospital stay was 11.1 days (range 1–60). At 30-day follow-up, the overall bypass patency rate was 97.4%, and the rate of open or endo reinterventions for failing bypass was 5.4%. At six-month follow-up, the estimated primary patency, primary assisted patency, secondary patency, and limb salvage were 78.1%, 86.2%, 92.1%, and 94.7%, respectively.ConclusionsPreliminary intraprocedural outcomes of the LIMBSAVE registry show that the in situ technique with the valvulotome is safe and effective in disrupting valves and obtaining pulsatility in the saphenous vein. The complication rate related to the use of the valvulotome is low. The six-month preliminary outcomes in terms of overall patency and limb salvage are promising. Further examinations and continuous follow-up are needed to evaluate long-term outcomes.

To assess the reliability of a simple, accessible, cost-effective rule-out tool, for use in triaging patients with Bethesda IV nodules to appropriate surgery. The diagnostic tool was assembled by combining the negativity for suspicious ultrasound features (irregular margins, microcalcification, and a taller-than-wide orientation), and mutational marker negativity (BRAF and NRAS). The tool, (US−/mutation−), was tested on 167 patients with solitary Bethesda IV nodules. The primary outcome was its negative predictive value (NPV) for lesions requiring total thyroidectomy (TT). The impact of mutational marker negativity, as part of the tool, was evaluated by comparing the NPV of (US−/mutation−) to that of (US−/mutation+). 10 out of 167 lesions were positive for a mutational marker. These underwent TT, and only 2/10 (20%) were benign, on final histology. In 6/8 malignant lesions, TT was concordant with current clinical guidelines. 157 patients comprised the negative study cohort, for both mutational markers and suspicious US features. These underwent thyroid lobectomy, and 17 cases resulted in malignancy, only 8 of which required completion thyroidectomy. Accordingly, the NPV of (US−/mutation−) for malignancy was 89% (140/157), and 95% (149/157) for malignancy requiring TT. However, the NPV of (US−/mutation+) was 20% for malignancy, and 40% for malignancy requiring TT. These differences were statistically significant (89% vs. 20%; p

Background Insights into the mechanism of resistance to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) could provide important information for further patient management, including the choice of second-line treatment. The EGFR T790M mutation is the most common mechanism of resistance to first- and second-generation EGFR TKIs. Owing to its biologic relevance in the response of non–small-cell lung cancer (NSCLC) to the selective pressure of treatment, the present study investigated whether the occurrence of T790M at progression differed among patients receiving gefitinib, erlotinib, or afatinib. Patients and Methods The present retrospective study included patients with NSCLC with an EGFR activating mutation, who had received gefitinib, erlotinib, or afatinib as first-line treatment. Plasma samples for the analysis of cell-free DNA were taken at disease progression and analyzed using a digital droplet polymerase chain reaction EGFR mutation assay. Results A total of 83 patients were enrolled; 42 had received gefitinib or erlotinib and 41afatinib. The patient characteristics were comparable across the 2 groups. The median time to progression (TTP) was 14.4 months for the gefitinib and erlotinib group and 10.2 months for the afatinib group (P = .09). Of the 83 patients, 47 (56.6%) were positive for the T790M in plasma. A greater incidence of T790M was observed in patients with progression during gefitinib or erlotinib therapy compared with patients treated with afatinib (33 [79%] vs. 14 [34%], respectively; odds ratio, 7.1; 95% confidence interval, 2.7-18.5; P = .0001). Conclusions Although gefitinib, erlotinib, and afatinib showed a comparable TTP in patients receiving first-line therapy, the incidence of T790M differed among them, as demonstrated by the present study, which could have implications for the choice of second-line treatment.

Fewer than 100 cases of amiodarone-induced thyrotoxicosis (AIT) managed surgically have been reported worldwide. This study aims to assess the outcome of thyroidectomy under general anesthesia in a relatively large case series. A retrospective analysis of the clinical records of 53 patients who underwent thyroidectomy for AIT between 1995 and 2019 was conducted. There were 48 (90%) males and 5 females with an average age of 63.7 years. Type 1 and 2 AIT were present in 35 (66%) and 18 (34%) of patients, respectively. The mean preoperative ejection fraction (EF) was 45 ± 13%. Salvage surgery was performed in 6 (11%) patients due to decompensating heart failure and/or malignant arrhythmias. 35 (66%) patients underwent urgent surgery due to a predicted late response to medical therapy and/or the need to discontinue it. Elective surgery was performed in the remainder. A considerable improvement in mean EF occurred 12 months post-surgery (44% vs. 49%; p 0.001). The overall survival rate following thyroidectomy was 96% at 12 months, and 83% at 5 years. No survival differences were observed based on systolic function. Cardiac-specific mortality was 11%, and these patients demonstrated a considerably shorter survival post-surgery compared to those who died of a non-cardiac cause (27 ± 18 vs. 77.5 ± 54 months; p 0.05). Total thyroidectomy can be safely performed under general anesthesia despite severe cardiac disease. It considerably improves cardiac function and confers a survival advantage. Therefore, it should be considered early in the treatment plan of select cases.

Backgrounds and aims To investigate relevant indicators of quality of care in a large population-based sample of people with diabetes representative of clinical practice in Italy in 2018. Methods and results We analyzed data from 11,300,750 subjects. All administrative healthcare claims collected in 2018 were scrutinized to identify subjects with diabetes and investigate several indicators of quality of care. Subjects with diabetes were identified by anti-hyperglycemic drug prescriptions, disease-specific co-payment exemption and hospital discharge codes. Indicators of quality of care pertained to monitoring (HbA1c, creatinine, lipid profile, microalbuminuria, eye examination, ECG, ultrasonography of carotid and lower limb arteries) and diabetes treatment (anti-hyperglycemic agents in subjects with cardiovascular disease, CVD). Subjects attending and nonattending Diabetes Clinics were compared. We identified 697,208 individuals with diabetes. HbA1c was assessed at least once in the year in 62.7%, creatinine in 62.3%, total cholesterol in 59.6%, microalbuminuria in 34.3%. Frequency of eye examination was 8.2%, ECG 23.5%, carotid ultrasonography 14.3%, lower limb ultrasonography 7.6%. Among anti-hyperglycemic drugs, SGLT-2 inhibitors were prescribed to ~5% and GLP-1 receptor agonists to ~5% although the proportion of subjects with CVD was ~45%. Subjects attending Diabetes Clinics had higher figures for all these monitoring and treatment indicators. Conclusions The implementation of national and international guidelines regarding disease monitoring and treatment is far from being satisfactory, especially among subjects nonattending Diabetes Clinics. Further efforts and investments are needed for better disseminating guidelines, more efficaciously engaging healthcare professionals and more strongly empowering the healthcare system to improve diabetes care.

To assess the prognostic relevance of baseline and post-treatment skeletal muscle index (SMI) and skeletal muscle radiation attenuation (SMRA) at the level of third lumbar vertebra in patients with ovarian cancer who underwent primary surgery and platinum-based chemotherapy.This retrospective investigation analyzed 134 patients who underwent staging computed tomography, surgery, chemotherapy and post-treatment computed tomography.At univariate analysis, stage (p0.0001), histotype (p=0.01), residual disease (p0.0001) and treatment response (p0.0001) correlated with progression-free survival (PFS), whereas age (p=0.004), stage (p=0.006), residual disease (p0.0001) and treatment response (p0.0001) were associated with overall survival (OS). Neither baseline nor post-treatment SMI and SMRA had prognostic relevance. At multivariate analysis, residual disease and treatment response correlated with PFS (p0.0001 and p0.0001) and OS (p=0.007 and p0.0001), whilst age was an independent prognostic variable for OS (p=0.02).Baseline and post-treatment SMI and SMRA did not correlate with patient outcome in this clinical setting.

COVID-19 has profoundly modified the way healthcare is delivered. Jordan imposed lockdown and restrictive policies between March 17 and May 20, 2020. We aimed to assess the impact of such measures on thyroid cancer treatment plans. In the specified period, 12 patients were scheduled for surgery. Since papillary carcinoma was the preoperative diagnosis in all cases, radioactive iodine ablation (RIA) therapy was also planned 3–4 weeks following surgery after withdrawing thyroxine and achieving a thyroid stimulating hormone (TSH) level > 30 mU/L. Thyroxine withdrawal is the routine method applied for RIA in Jordan as it is less costly compared to the rapid method of exogenous stimulation using recombinant TSH. All surgical procedures were performed without delay since all patients were asymptomatic per flu-like illness and came from a region of low COVID-19 prevalence. These included total thyroidectomy (n = 11), bilateral therapeutic central compartment neck dissection (n = 7), lateral compartment neck dissection (n = 5). However, the RIA treatment plan was altered considerably according to the period in which they were operated. 6 out of the 7 patients operated in March changed to the stimulated method of RIA at a considerable additional extra cost. The seventh patient and the April patient opt to delay RIA until after lockdown. The remaining cases (operated in May) followed the usual withdrawal method as restrictions were due to an end. The restrictive measures applied during COVID-19 did not affect the safe and timely delivery of surgical care. However, it added a financial and psychological burden to the entire cancer management plan.

Purpose: To compare the inverted flap and the subretinal aspiration technique for full-thickness macular hole (FTMH) surgery. Methods: Forty consecutive eyes with a stage IV FTMH were randomly assigned into 2 treatment groups. After core vitrectomy and perimacular internal limiting membrane (ILM) peeling, in group A, the subretinal remnant macular fluid was aspirated with a 41-G cannula after the air-fluid exchange procedure, while in group B, the technique of an inverted ILM flap was completed. Differences in postoperative best-corrected visual acuity (BCVA) and occurrence of intraoperative or postoperative complications between the 2 groups were evaluated. Results: All FTMHs were closed after the first surgery with no intraoperative or postoperative complications. In group A, 16 patients (80%) showed improvement of BCVA and 4 (20%) showed stabilization. In group B, 12 patients (60%) had improved BCVA, while 6 (30%) remained stable and 2 (10%) worsened. Postoperative BCVA for group A was significantly better than for group B (p = 0.022). Conclusions: The surgical techniques had similar rates of closure of FTMH, although BCVA outcomes were significantly better in the subretinal aspiration group.

Background/aim To assess the prognostic relevance of volume-based parameters [whole body (wb)-metabolic tumor volume (MTV) and wb-total lesion glycolysis (TLG)] of pretreatment PET/CT in patients with potentially platinum-responsive recurrent ovarian cancer. Patients and methods This retrospective investigation analyzed 67 patients at first relapse. Results At univariate analysis, post-relapse survival and overall survival correlated with residual disease after primary surgery (RD) (p=0.015 and 0.049, respectively), time to recurrence (p=0.005 and p=0.0003), number of recurrence sites (p=0.001 and p=0.0005), treatment at recurrence (p=0.044 and 0.043) and wb-MTV (p=0.023 and 0.021) but not with wb-TLG. RD, time to recurrence and number of recurrence sites, but not wb-MTV, were independent prognostic variables for post-relapse survival, and time to recurrence and number of recurrence sites, but not wb-MTV, were independent prognostic factors for overall survival. Conclusion Volume-based parameters of PET/CT are not independent predictors of clinical outcome in potentially platinum-responsive recurrent ovarian cancer.

Context Recent diagnostic criteria updates of the tall cell variant of papillary thyroid carcinoma (TCPTC) by the World Health Organization (WHO) have determined the inclusion of tumors with 30% to 49% of tall cells. However, the impact of tall cell percentage on papillary thyroid carcinoma (PTC) patients’ prognosis is still debated. Objective We aimed to evaluate whether tall cell percentage affects patient outcome in the absence of aggressive features. Methods Rates of aggressive features, recurrence-free survival (RFS), and distant RFS (5-year median follow-up) were compared among tumors with less than 30%, 30% to 49% and at least 50% tall cells. We also evaluated the impact of the new tall cell cutoff on patient management. Results Overall, 3092 tumors (15.7% of all PTCs) were collected: A total of 792 PTCs had less than 30%, 503 had 30% to 49%, and 1797 had 50% or more tall cell areas. With the new WHO definition, the number of TCPTCs increased by 28%. There were no differences in recurrence rates according to tall cell percentage. The coexistence of BRAF and TERT promoter mutations predicted a worse RFS. Considering the new definition of TCPTC, the level of risk according to the American Thyroid Association increased from low to intermediate in 4.2% of cases. However, the recurrence rate within this subgroup was comparable to low risk. Conclusion TCPTC and PTC with tall cell areas can be considered as a unique group with similar recurrence risk. However, whenever aggressive features are absent, tumors have a low risk of recurrence independently of tall cell percentage.

ContextAtypical parathyroid adenomas (APAs) are neoplasms with uncertain malignant potential but lack unequivocal histological signs of malignancy.ObjectiveThis work aims to retrospectively evaluate the clinical and biochemical profiles of patients with APA, the outcome after parathyroidectomy (PTX), and the presence of CDC73 germline and somatic mutations.MethodsThis monocentric study was conducted on consecutive patients undergoing PTX for primary hyperparathyroidism (PHPT) between June 2000 and December 2020. Fifty-eight patients with a confirmed histopathological diagnosis of APA, and age- and sex-matched controls with parathyroid adenoma (PA) were also included.ResultsFifty-four patients had sporadic PHPT and 4 had familial isolated hyperparathyroidism (FIHP). Thirty-four patients (59%) had symptomatic disease. Serum calcium and parathyroid hormone (PTH) levels were significantly higher in symptomatic compared to asymptomatic patients (P = .048 and .008, respectively). FIHP patients were younger than their sporadic counterparts (30 ± 17 years vs 55 ± 13 years). APA patients had significantly higher serum calcium and PTH levels and lower 25-hydroxyvitamin D concentration, bone mineral density, and T score at one-third distal radius compared to those with PA. Four of 56 APA patients displayed a CDC73 germline mutation. No somatic CDC73 mutation was identified in 24 tumor specimens. The mean follow-up after surgery was 60 ± 56.4 months. All but 6 patients (90%), 5 with apparently sporadic PHPT and 1 with FIHP, were cured after surgery.ConclusionThe large majority of patients with APA, despite a moderate/severe phenotype, have a good prognosis. Germline CDC73 mutation–positive patients had a higher rate of persistent/recurrent disease. CDC73 gene alterations do not seem to have a relevant role in the tumorigenesis of sporadic APA.

Postural instability and increased risk of falls are relevant problems in patients with fragility vertebral fractures (VFs). The inter-relationship between flexed posture (FP), VFs and altered balance control is complex and only partially elucidated. The purpose of the study is to identify key factors of balance impairment in osteoporotic patients with VFs. In particular, we focused on the role of FP, number and severity of VFs and their relationships with clinical and static balance instrumental measures. Secondary aim of the study is to investigate possible correlations of stabilometric parameters with clinical and functional outcome measures. The results showed no significant correlations between static balance parameters and FP, number and severity of VFs. Stabilometry measures weakly correlate with age, 20 meters Walking Test and Barthel Index. Further studies are required to improve our understanding of the mechanisms underlying balance impairment in patients with VFs with the aim of identifying early clinical and instrumental markers of poor balance and fall's risk.

Aims Albuminuric and non-albuminuric phenotypes of chronic kidney disease (CKD) may have different cardiovascular risk and survival in type 1 diabetes (T1DM). Herein we estimated risk of major vascular outcomes by the EURODIAB PCS score and determined all-cause mortality rate in 774 T1DM according to CKD phenotypes. Methods We evaluated the distribution of CKD phenotypes [no CKD, stages 1–2, non-albuminuric stage ≥3 (Alb−CKD), albuminuric stage ≥3 (Alb+CKD)], the EURODIAB risk score for major vascular outcomes [low- (LS), intermediate- (IS), and high- (HS) risk] and all-cause mortality over a follow-up of 8.25 ± 2.34 years. Results Out of 774 subjects, 692 (89.4%) had no CKD, 53 (6.8%) CKD stages 1–2, 17 (2.2%) Alb−CKD and 12 (1.6%) Alb+CKD; 466 (60.2%) had LS, 205 (26.5%) IS and 103 (13.3%) HS. Distribution of HS was: no CKD, 9.1%; CKD stages 1–2, 34.0%; Alb−CKD, 64.7%; Alb+CKD, 91.7% (P Conclusions In our T1DM cohort, one fifth of those with CKDs were non-albuminuric. This phenotype was associated with higher risk of major outcomes and similar rate of mortality as compared to CKD stages 1–2. The greatest risk and highest mortality occur in patients with Alb+CKD.

BACKGROUND Left ventricular (LV) diastolic dysfunction (DD) is a frequent finding in obesity and may predispose to the development of heart failure (HF). However, no data are available on the prevalence of DD after the introduction of the 2016 Recommendations of the American Society of Echocardiography and the European Association of Cardiovascular Imaging. METHODS AND RESULTS To assess the impact of the new Recommendations on the prevalence of DD and on their clinical and echocardiographic correlates in obesity, a prospective study was performed in 588 subjects with an ejection fraction (EF) ≥50% and no history of HF either obese (n = 402; mean age: 47 ± 12 years; women 71%; body mass index [BMI]: 44 ± 8 kg/m2 ), overweight (n = 86; BMI: 28 ± 1 kg/m2 ), or with a normal weight (n = 100; BMI: 22 ± 2 kg/m2 ). All subjects underwent an echocardiographic and Doppler study, including the assessment of global longitudinal strain (GLS). DD occurred in 19% of obese patients, 12% of overweight subjects, and 2% of normal weight subjects. We used multivariable logistic analysis to assess the risk of DD. In patients with BMI ≥30 kg/m2 , LV mass normalized to height (2.7) (OR: 1.04, P = .0028), and GLS (OR: 0.85, P = .0032) were associated with an increased risk of DD followed by EF (OR: 0.91, P = .045), diabetes (OR: 1.91, P = .065), and systolic blood pressure (OR: 1.02, P = .076). CONCLUSION These results show that DD is highly prevalent among obese subjects and impairment of longitudinal systolic mechanics, as reflected by GLS reduction, and LV mass normalized to height are major independent predictors of DD in this patients' population.

// Roberta Zuntini 1 , Laura Cortesi 2 , Daniele Calistri 3 , Tommaso Pippucci 1 , Pier Luigi Martelli 4 , Rita Casadio 4 , Elisa Capizzi 5 , Donatella Santini 5 , Sara Miccoli 1 , Veronica Medici 2 , Rita Danesi 3 , Isabella Marchi 2 , Valentina Zampiga 3 , Michelangelo Fiorentino 5 , Simona Ferrari 1 , Daniela Turchetti 1 1 Dipartimento di Scienze Mediche e Chirurgiche, Centro di Ricerca sui Tumori Ereditari, UO Genetica Medica, Universita di Bologna, Bologna, Italy 2 Dipartimento di Oncologia ed Ematologia, Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, Italy 3 Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy 4 Biocomputing Group, BIGEA/Giorgio Prodi Interdepartmental Center for Cancer Research, Universita di Bologna, Bologna, Italy 5 UO Anatomia Patologica, Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola-Malpighi, Bologna, Italy Correspondence to: Daniela Turchetti, email: daniela.turchetti@unibo.it Keywords: BRCA1, ovarian cancer, hereditary cancer, VUS, breast cancer Received: October 24, 2016 Accepted: January 26, 2017 Published: February 07, 2017 ABSTRACT We have investigated the clinical significance of the BRCA1 variant p.His1673del in 14 families from the Emilia-Romagna region of Italy, including 20 breast and 23 ovarian cancer cases; four families displayed site-specific ovarian cancer. The variant, absent in human variation databases, has been reported three times in BRCA1 specific databases; all probands shared the same rare haplotype at the BRCA1 locus, consistent with a common ancestor. The multifactorial likelihood method by Goldgar, used to estimate the probability of the variant being causative, gave a ratio of 2,263,474:1 in favor of causality. Moreover, in silico modeling suggested that His1673-lacking BRCA1 protein may have a decreased ability to bind BARD1 and other related proteins. All six ovarian carcinomas and two out of four breast carcinomas available showed a loss of the BRCA1 wild-type allele, which in three out of four ovarian carcinomas analyzed by FISH was associated with duplication of the chromosome 17 containing the variant. Although the pathogenicity of the allele is strongly supported by the multifactorial ratio,we cannot exclude that p.His1673del is not itself deleterious, but is linked to another undetected mutation on the same ancestral allele.

Robot-assisted transaxillary thyroidectomy (RATT) is an emerging technique with excellent cosmetic results but is supposedly more invasive and painful than conventional thyroidectomy (CT). This prospective study compared pain after RATT and CT.Inclusion criteria were a nodule5 cm and volume30 mL. Patients received the same analgesia. Pain was evaluated by visual analog scale (VAS) in the recovery room (VASrr), on the first postoperative day at 8:00 a.m. (VAS 8 a.m.) and 8:00 p.m. (VAS 8 p.m.), at 8:00 a.m. on the second postoperative day (VAS 8*a.m.), and after 7 days (VAS 7). Operative time and complications were evaluated.From May 2015 to September 2015, 124 patients (all women) underwent thyroidectomy: 62 underwent RATT and 62 underwent CT. Mean age was 39.7 ± 10.2 years in the RATT group and 41.4 ± 12.5 years in the CT group. Groups were comparable for thyroid volume and nodule diameter. Operative time was longer in the RATT group than in the CT group (119.4 ± 25.5 versus 70.3 ± 11.0 minutes). Complications were three transient hypocalcemia in RATT and four in the CT group. No definitive complications occurred. VASrr was lower in the RATT group (1.79 ± 2.06 versus 2.5 ± 1.18; P .0001). There was no difference between groups for VAS 8 a.m., VAS 8 p.m., and VAS 8*a.m., but VAS 7 was higher in the RATT group (0.85 ± 1.77 versus 0.17 ± 0.52; P .010).RATT is as safe and effective as CT. Patients undergoing RATT, surprisingly, experienced less pain in the immediate postoperative period. However, the VAS 7 score was higher in the RATT group, probably because the intact neck is favorable in the early phase of recovery, but the large dissection takes longer for healing.

Aims: To assess whereas prevalence, treatment and direct costs of drug-treated dia-betes were similar in migrants and in people of Italian citizenship under the universalistic Italian health care system. Methods and results: Drug-treated diabetic individuals were identified in the population-based multiregional ARNO Observatory on the basis of 2010 prescriptions. Migrants were identified by the country-of-birth code on the fiscal identification code. Diabetes prevalence was calculated for Italians (n Z 7,328,383) and migrants (n Z 527,965). To assess the odds of migrants of having diabetes compared to Italians, we individually matched all migrants to Italians for major con-founders (age, sex and place of residence). Finally, all migrants with diabetes were individually matched for confounders to Italians with diabetes to compare prescriptions, hospitalization rates, services use and direct costs for the National Health System. We identified 368,797 sub-jects with diabetes among Italians and 10,336 among migrants, giving prevalence of 5.03% and 1.96%, respectively. Migrants with diabetes were younger than Italians (52 13 years vs. 68 14 years, P < 0.001); after matching, their risk of disease was higher (odds ratio, 1.55, 95% confidence interval, 1.50e1.60). The total cost was 27% lower in migrants, due to lower cost of drugs (29%), hospital admission (27%) and health services (22%). The number of packages/treated person-year of all glucose-lowering drugs was also lower in migrants (15%) (P < 0.001). Conclusions: Compared to subjects of Italian ancestry, migrants to Italy show a higher risk of diabetes but less intense treatment. Inequalities in health care use are likely and are maintained also in a universalistic system.

Purpose To evaluate the efficacy and safety of radiofrequency (RF) ablation in the treatment of benign thyroid nodules (BTNs) by applying a modification of the moving-shot technique. Materials and Methods Fifty-one BTNs in 46 patients for whom surgery was contraindicated or who refused surgery were treated with RF ablation: 31 had lesion volumes 3 (group A) and 20 had volumes ≥ 20 cm 3 (group B). The solid component percentage of each lesion was assessed, and any present fluid component was aspirated. Symptomatic scores and cosmetic scores (CSs) were assessed. All RF ablations were performed under ultrasound (US) guidance with an 18-gauge electrode. Treatment response was evaluated by contrast-enhanced US at 6-month intervals for 18 months in group A. In group B, after the 6- and 12-month follow-up assessments, a second treatment was performed in selected cases, and the 6-month contrast-enhanced US follow-up was started again. Volume reduction rate (VRR) was evaluated at each follow-up examination. Results No permanent paralysis of the laryngeal nerve was observed; 2 patients experienced transient hoarseness. In all nodules treated with a single RF ablation session, the VRRs at 6, 12, and 18 months were 69.4%, 78.7%, and 84% in group A, respectively, and 66.6%, 79.4%, and 81.5% in group B, respectively. The VRRs of group B nodules treated with a second RF ablation procedure (n = 6) were 86.4% and 88.2% at 6 and 12 mo after the second treatment, respectively. All patients reported symptom relief and CS improvement. Conclusions RF ablation is a reliable alternative to surgery in patients affected by BTNs and can be safely repeated in selected cases.

Robot-assisted transaxillary thyroidectomy (RATT) is widely accepted in Asian countries. However, concerns regarding the balance between its real advantages and safety and cost have been raised by North American authorities. In Europe, assessments have been limited by small numbers since now. The purpose here is to report a large European experience with RATT. A retrospective analysis was conducted of 257 patients who underwent RATT for nodular disease between February 2012 and September 2016. Data collected included patient demographics, diagnosis, ultrasound-estimated mean thyroid volume and nodule size, type of resection, operative time, postoperative pain and morbidity, and the hospital length of stay. Pain was assessed by visual analog scale score 12 h postoperatively (on the first postoperative day, before discharge). Feasibility, effectiveness, and safety were the outcomes of interest. Follow-up of thyroid carcinoma patients was carried out measuring thyroglobulin levels and ultrasound examination (median follow-up 24 months (6–48 months)). First control after 12 months and successively once a year. There were 253 women and 4 men, with a mean age of 37.3 years. Indications included benign disease in 116, papillary carcinoma in 56, and indeterminate nodule in 85. Mean thyroid volume was 16.8 mL, and nodule size was 25.3 mm. A hemithyroidectomy was performed in 138 patients and total thyroidectomy in 118. The mean operative time was 77.5 min for the former and 99.7 min for the latter. One conversion was required. Complications included transient hypoparathyroidism in 7/118 (total thyroidectomy) patients (5.9%), transient vocal fold palsy in 3/257 (1.1%), 1 delayed tracheal injury (0.4%), and 3 postoperative hematoma (1.1%). Mean visual analog scale score was 1.79, and the mean length of stay was 1.6 days for hemithyroidectomy and 1.9 days for total thyroidectomy. RATT is safe and effective and could serve as a viable treatment modality in selected cases.

Androgen Receptor (AR) positivity is often displayed in breast cancer and especially in Male Breast Cancer (MBC), where it appears to be a heterogeneous feature, with its expression ranging between 38 and 81% of cases. Given the fact that circulating androgens represent the most important sex hormones in males and that breast carcinogenesis is characteristically subjected to hormonal mechanisms, our purpose was to investigate the clinicopathological significance of AR in MBC assessing if its expression could be associated with parameters of tumor aggressiveness.Clinical and pathological data were retrospectively reviewed for male patients with a diagnosis of invasive breast cancer. AR status was detected by immunohistochemistry on formalin-fixed, paraffin-embedded tumoral tissue sections. Correlations between AR expression and histopathological features were assessed using univariate and multiple comparisons where appropriate, assuming P values 0.05 as statistically significant.The study included 44 consecutive male patients. AR expression ranged between 10 and 98% and the majority of cases presented a moderate to high expression of this receptor. Adopting a 20% PgR cut-off, statistical analyses highlighted a different behavior of AR: in ERHormonal factors reveal to play a crucial role in MBC carcinogenesis and progression. Intriguingly, in ER

Marginal bone loss (MBL) represents an important indicator of peri-implant health and the measure of its level is considered a determining factor in the evaluation of the quality of survival. Aim of this study is to compare radiographic changes in the fractal and mesial/distal vertical dimensions of peri-implant trabecular bone of dental implants with a laser-ablated micron-scale modication (LAM) of collar surface after a 5-year follow-up period.Thirty-four implants with LAM of collar surface (test group = TG) and 31 implants without LAM of collar surface (control group = CG) were placed in 45 non-smoking, periodontally healthy patients. Fractal and vertical dimensions of peri-implant trabecular bone were measured by comparing radiographs taken immediately after prosthesis delivery with those taken 3 years and 5 years after functional loading.At the end of the 5-year follow-up, the MBL in the TG was 0.87±0.21 and 0.75±0.25 mm at the mesial and distal aspects, respectively, while a MBL of 2.05±0.25 mm at the mesial aspect and 2.01±0.34 mm at the distal site was recorded in the CG. A statistically significant difference was noted. In the TG the mean fractal dimension before loading was 1.4213±0.0525. It increased significantly to 1.4329±0.0479 at 3 years after loading and remained almost stable at 5 years after loading (1.4327±0.0291). In the CG the mean fractal dimension before loading was 1.4119±0.0414. It increased significantly to 1.4282±0.0324 at 3 years after loading and decreased significantly to 1.4111±0.0624 at 5 years after loading. At the end of the follow-up, differences between both study groups were statistically significant.The increased fractal dimension and the reduced MBL around TG implants after 5 years of functional loading indicates a positive effect of a laser-ablated micron-scale modication of collar surface on peri-implant trabecular bone remodeling.

Introduction: The aim of this study is to describe our experience in the treatment of femoropopliteal occlusive disease with percutaneous transluminal angioplasty (PTA) followed by stenting with S.M.A.R.T. Flex vascular stent system. Materials and Methods: From June 2014 to October 2018, 80 patients were treated at our Institution for intermittent claudication, critical, or acute limb ischemia due to total occlusion or long diffused lesions of the femoropopliteal segment. Main study end points are primary patency, target lesion revascularization, and stent fractures; secondary end points are major amputation rate, procedure-related bleeding, incidence of intrastent restenosis, and primary assisted patency after reintervention. Results: Mean follow-up time was 21 months (range 2-48 months). Primary patency rate was 80% (64 patients of 80), with mean covered lesion length of 8.2 cm. The deployment of a single stent was obtained for 57 (89%) patients, with a mean stent length of 9.86 cm. Of 80 patients, 2 (2.5%) had early stent occlusion within first 48 hours after the procedure, while 4 (5%) of 80 patients experienced stent occlusion within first 6 months. Of 80 patients, 6 (7.5%) had an intrastent restenosis detected at duplex ultrasound with a primary-assisted patency after simple re-PTA procedures of 83.3% at 12 months. Discussion: In the literature, primary patency after PTA and stenting of the femoropopliteal trunk seems to be related to several variables, such as number of stents used, specific stent length, diameters, type and length of lesions, type of pathology (if acute or chronic), and number of preoperatory patent below-the-knee vessels. In this study, we try to analyze each single factor in order to understand their role in predisposing specific stent restenosis. Conclusions: S.M.A.R.T. Flex vascular stent system has shown good results in terms of primary patency in the treatment of calcified lesions both at SFA and at popliteal level. However, in our experience, stent patency seems to be significantly poorer in patients presenting with acute limb ischemia associated with chronic atherosclerotic disease as well as for lesions located in the mid-distal part of the popliteal artery and both when number of stents increases or number of runoff vessel decreases.

Background The contractile response of patients with heart failure (HF) may be assessed by exercise stress echocardiography (ESE)-derived indexes. We sought to test whether ESE parameters are useful to identify the risk of adverse left ventricular (LV) remodeling in patients with chronic HF and reduced or mildly reduced LV ejection fraction (EF). Methods We enrolled 155 stabilized patients (age: 62 ± 11 years, 17% female, coronary artery disease 47%) with chronic HF, LV EF ≤50% and LV end-diastolic volume index > 75 ml/m2. All patients underwent a symptom-limited graded bicycle semi-supine ESE, with evaluation of peak stress LV EF, end-systolic pressure-volume relation (ESPVR, i.e. LV elastance) and cardiac power output to LV mass (CPOM). A complete echocardiographic study was performed at baseline and after 6 ± 3 months. Adverse LV remodeling was defined as the association of eccentric LV hypertrophy (LV mass: ≥115 g/m2 for male and ≥ 95 g/m2 for women, and relative wall thickness

OBJECTIVE Segmental carotid-femoral pulse-wave velocity (PWV) is a gold standard method for arterial stiffness assessment; recently, a local carotid PWV measurement by ultrasound has been developed. The present study compared the impact of age and established risk factors on carotid and carotid-femoral PWV. METHODS Three hundred and seven volunteers (167 men; age from 15 to 78 years) free of cardiovascular disease, diabetes, antihypertensive and lipid-lowering treatment underwent sequential measurement of carotid and carotid-femoral PWV. RESULTS In the entire study population, both carotid and carotid-femoral PWV were independently associated mainly with age and blood pressure. In individuals more than 50 years old (N = 132, 80 men), carotid-femoral PWV, but not carotid PWV, was also associated with high-density lipoprotein (HDL)-cholesterol and fasting glucose. The annual increase in carotid and carotid-femoral PWV was similar (0.087 ± 0.004 and 0.090 ± 0.005 m/s, respectively; P = 0.69). Carotid PWV increased with age more rapidly in women than in men (0.099 ± 0.005 vs. 0.076 ± 0.005 m/s per year, P

Background The best treatment option for patients with type 2 diabetes in whom treatment with metformin alone fails to achieve adequate glycaemic control is debated. We aimed to compare the long-term effects of pioglitazone versus sulfonylureas, given in addition to metformin, on cardiovascular events in patients with type 2 diabetes. Methods TOSCA.IT was a multicentre, randomised, pragmatic clinical trial, in which patients aged 50–75 years with type 2 diabetes inadequately controlled with metformin monotherapy (2–3 g per day) were recruited from 57 diabetes clinics in Italy. Patients were randomly assigned (1:1), by permuted blocks randomisation (block size 10), stratified by site and previous cardiovascular events, to add-on pioglitazone (15–45 mg) or a sulfonylurea (5–15 mg glibenclamide, 2–6 mg glimepiride, or 30–120 mg gliclazide, in accordance with local practice). The trial was unblinded, but event adjudicators were unaware of treatment assignment. The primary outcome, assessed with a Cox proportional-hazards model, was a composite of first occurrence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularisation, assessed in the modified intention-to-treat population (all randomly assigned participants with baseline data available and without any protocol violations in relation to inclusion or exclusion criteria). This study is registered with ClinicalTrials.gov, number NCT00700856. Findings Between Sept 18, 2008, and Jan 15, 2014, 3028 patients were randomly assigned and included in the analyses. 1535 were assigned to pioglitazone and 1493 to sulfonylureas (glibenclamide 24 [2%], glimepiride 723 [48%], gliclazide 745 [50%]). At baseline, 335 (11%) participants had a previous cardiovascular event. The study was stopped early on the basis of a futility analysis after a median follow-up of 57·3 months. The primary outcome occurred in 105 patients (1·5 per 100 person-years) who were given pioglitazone and 108 (1·5 per 100 person-years) who were given sulfonylureas (hazard ratio 0·96, 95% CI 0·74–1·26, p=0·79). Fewer patients had hypoglycaemias in the pioglitazone group than in the sulfonylureas group (148 [10%] vs 508 [34%], p

Background and aims Familial hypercholesterolemia (FH) is an inherited disorder characterized by high levels of blood cholesterol from birth and premature coronary heart disease. Thus, the identification of FH patients is crucial to prevent or delay the onset of cardiovascular events, and the availability of a tool helping with the diagnosis in the setting of general medicine is essential to improve FH patient identification. Methods This study evaluated the performance of the Dutch Lipid Clinic Network (DLCN) score in FH patients enrolled in the LIPIGEN study, an Italian integrated network aimed at improving the identification of patients with genetic dyslipidaemias, including FH. Results The DLCN score was applied on a sample of 1377 adults (mean age 42.9 ± 14.2 years) with genetic diagnosis of FH, resulting in 28.5% of the sample classified as probable FH and 37.9% as classified definite FH. Among these subjects, 43.4% had at least one missing data out of 8, and about 10.0% had 4 missing data or more. When analyzed based on the type of missing data, a higher percentage of subjects with at least 1 missing data in the clinical history or physical examination was classified as possible FH (DLCN score 3–5). We also found that using real or estimated pre-treatment LDL-C levels may significantly modify the DLCN score. Conclusions Although the DLCN score is a useful tool for physicians in the diagnosis of FH, it may be limited by the complexity to retrieve all the essential information, suggesting a crucial role of the clinical judgement in the identification of FH subjects.

PURPOSE: Optimal management of adrenocortical carcinoma (ACC) involves a detailed diagnostic workup, radical surgery, and appropriate adjuvant therapy. However, due to the rarity of this disease, adequate expertise is necessary to ensure optimal patient care. We evaluated if the experience of a treating center influences the outcome of ACC. METHODS: Two hundred sixty-three patients who underwent adrenalectomy for ACC were included in a multi-institutional surgical survey and divided into 2 groups: "high-volume center" (HVC) (≥10 adrenalectomies for ACC) and "low-volume center" (LVC) (

In a retrospective, observational, cross-sectional, single-centre study, we assessed the prevalence and correlates of different CKD phenotypes (with and without albuminuria) in a large cohort of patients of white ethnicity with type 1 diabetes. From 2001 to 2009, 408 men and 369 women with type 1 diabetes (age 40.2 ± 11.7 years, diabetes duration 19.4 ± 12.2 years, HbA1c 7.83 ± 1.17% [62.0 ± 12.9 mmol/mol]) were recruited consecutively. Albumin-to-creatinine ratio (ACR) and eGFR (Modification of Diet in Renal Disease) were obtained for all individuals, together with CKD stage. Diabetic retinopathy and peripheral polyneuropathy were detected in 41.5% and 8.1%, respectively, and cardiovascular disease (CVD) occurred in 8.5%. Adjudications of CKD phenotype were made by blinded investigators. Normo- (ACR

// Jinghui Lu 1 , Sanyuan Hu 1 , Paolo Miccoli 2 , Qingdong Zeng 1 , Shaozhuang Liu 1 , Lin Ran 3 , Chunxiao Hu 1 1 Department of General Surgery, Qilu Hospital of Shandong University, Jinan 250012, P.R. China 2 Department of General Surgery, University of Pisa, Pisa 56126, Italy 3 Medical College of Shandong University, Jinan 250012, P.R. China Correspondence to: Sanyuan Hu, email: husanyuan1962@hotmail.com Keywords: papillary thyroid microcarcinoma, metabolomics, diagnosis, NMR Received: August 20, 2016 Accepted: October 22, 2016 Published: November 07, 2016 ABSTRACT Papillary thyroid microcarcinoma (PTMC) is a subtype of papillary thyroid carcinoma (PTC). Because its diameter is less than 10 mm, diagnosing it accurately is difficult with traditional methods such as image examinations and FNA (Fine Needle Aspiration). Investigating the metabolic changes induced by PTMC may enhance the understanding of its pathogenesis and provide important information for a new diagnosis method and treatment plan. In this study, high resolution magic angle spin (HRMAS) spectroscopy and 1 H-nuclear magnetic resonance ( 1 H-NMR) spectroscopy were used to screen metabolic changes in thyroid tissues and plasma from PTMC patients respectively. The results revealed reduced levels of fatty acids and elevated levels of several amino acids (phenylalanine, tyrosine, lactate, serine, cystine, lysine, glutamine/glutamate, taurine, leucine, alanine, isoleucine and valine) in thyroid tissues, as well as reduced levels of amino acids such as valine, tyrosine, proline, lysine, leucine and elevated levels of glucose, mannose, pyruvate and 3-hydroxybutyrate in plasma, are involved in the metabolic alterations in PTMC. In addition, a receiver operating characteristic (ROC) curve model for PTMC prediction was able to classify cases with good sensitivity and specificity using 9 significant changed metabolites in plasma. This work illustrates that the NMR-based metabolomics approach is capable of providing more sensitive diagnostic results and more systematic therapeutic information for PTMC.

Objective Papillary thyroid microcarcinomas (microPTC) may be ’incidental’ (Inc-microPTC), occasionally found at histology after surgery for benign disease or ‘non-incidental’ (Non-Inc-microPTC), diagnosed on clinical grounds. It is unclear whether these different microPTC reflect the same disease. The aim of the study was to compare Inc-microPTC and Non-Inc-microPTC for clinical and histological features as well as for serum TSH, a known factor involved in PTC development. Design We evaluated histology and serum TSH levels of consecutive patients submitted to thyroidectomy for goiter with compressive symptoms or for cytological diagnosis suspicious/indicative of PTC. Methods In total, 665 consecutive patients (259 with a single thyroid nodule, SN and 406 with a multinodular gland, MN) were included in the study. According to histology, patients were classified as: benign nodular goiter (Benign, n=291); Inc-microPTC (n=92); Non-Inc-microPTC (n=67) and PTC≥1cm (macroPTC, n=215). Results Inc-microPTC were significantly more frequent in MN than in SN (66/406, 16.2% vs 26/259, 10.0%, P=0.02). Patients with Inc-microPTC compared with Non-Inc-microPTC were older (mean age±s.d. 53.3±13.2 years vs 44.9±14.8 years, P=0.0002), had a smaller tumor size (median 4mm vs 9mm, PP=0.001) and lower levels of TSH (median 0.6mIU/L, IR: 0.4–1.0mIU/L vs value 1. mIU/L, IR: 0.6–1.4mIU/L vs P=0.0001). Conclusion Incidental and non-incidental papillary thyroid microcarcinomas appear to be two different entities.

The aim of this study was to compare survival rates, marginal bone loss (MBL), and peri-implant soft tissue parameters between short and standard laser-microgrooved implants supporting single or splinted crowns 3 years after loading.30 subjects received 1 short (CSR of short implants was 98%, compared to 100% for standard implants, without significant statistical difference. MBL was not significantly different over the observation period, with an average of 0.23 ± 0.6 mm and 0.27 ± 0.3 mm for short and standard implants, respectively. No statistical differences were found between short and standard implants regarding plaque (14.7% vs. 15.7%), number of sites BOP (8.3% vs. 5.9%), probing depth (1.13 ± 0.6 mm vs. 1.04 ± 0.8 mm), and mean mucosal recession (0.18 ± 0.3 mm vs. 0.22 ± 0.3 mm). Analyzing MBL in relation to the C/I ratio, implant length, location, type of antagonist, and type of prosthetic design, no statistically significant differences were found.Regardless of C/I ratio, implant length, location, type of antagonist, and type of prosthetic design, short and standard laser-microgrooved implants had similar survival rates, MBL, and peri-implant soft tissue conditions over the observation period of 3 years.

BackgroundMicrovascular complications (MC) have been claimed to increase the risk for cardiovascular disease in diabetic subjects. However, the effect of MC burden on the risk of major vascular outcomes and all-cause mortality in type 1 diabetes is still poorly explored. We evaluated the relationship between microvascular complications burden and incidence of major cardiovascular events and all-cause mortality in subjects with type 1 diabetes.MethodsWe recruited 774 participants with type 1 diabetes in a single-center observational study over a follow-up of 10.8 ± 2.5 years. Hazard ratios (HR) for cardiovascular outcomes and all-cause death associated with microvascular complications were determined by unadjusted and adjusted Cox regression analysis.ResultsOut of 774 individuals, 54.9% had no-MC, 32.3% 1 MC, 9.7% 2 MC and 3.1% 3 MC. A total of 54 deaths (7.0%) occurred. Death rate increased from no-MC 2.1% (Ref) to 1 MC 7.2% (HR 3.54 [95% CI 1.59–7.87]), 2 MC 14.7% (HR 6.41 [95% CI 2.65–15.49]) and 3 MC 66.7% (HR 41.73 [95% CI 18.42–94.57], p ConclusionsIn type 1 diabetes, microvascular complications burden increases in an independent dose-dependent manner the risk of major cardiovascular outcomes and all-cause mortality. The presence and number of microvascular complications should be considered in stratifying overall cardiovascular risk in type 1 diabetes.

Objectives The aim of the present study was to improve the instrumental diagnosis of assessing Meniere's disease (MD) if the frequency and slow-phase velocity (SPV) of the thermally induced nystagmus analyzed through the caloric vestibular test (CVT) showed different alterations in relationship with an increasing severity of the cochlear involvement. Materials and methods The study retrospectively analyzed the CVT results of 72 patients affected by unilateral "definite MD" according to the 2015 Barany Society Diagnostic Criteria and treated only conservatively. Results There were 7 (9.72%) patients in stage 1, 27 (37.50%) in stage 2, 35 (48.61%) in stage 3, and 3 (4.16%) in stage 4. The canal paresis (CP) calculated through the frequency of the thermally induced nystagmus on the affected side increased in more severe stages (p=0.033). Conversely, the CP calculated through the SPV was not significantly different among the stages showing abnormal values even in the early phases of the disease (71% in stage 1, 81% in stage 2, 91% in stage 3, and 100% in stage 4), exclusively on the affected side. Conclusion Abnormalities of the thermally induced nystagmus on the affected side characterize most patients with MD, but only "SPV" alterations are common in the early stages. An increasing severity of the cochlear involvement progressively reflects also on the "frequency" parameter. Detecting a dissociation between these two parameters could represent an instrumental marker of the early forms of MD. Cite this article as: Cerchiai N, Navari E, Miccoli M, Casani AP. Meniere's Disease and Caloric Stimulation: Some News from an Old Test. J Int Adv Otol 2019; 15(3): 442-6.

AIMS Peak cardiac power output-to-mass (CPOM) represents a measure of the rate at which cardiac work is delivered respect to the potential energy stored in left ventricular (LV) mass. We studied the value of CPOM and cardiopulmonary exercise test (CPET) in risk stratification of patients with heart failure (HF). MATERIALS AND RESULTS We studied 159 patients with chronic HF (mean rest LV ejection fraction 30%) undergoing CPET and exercise stress echocardiography. CPOM was calculated as the product of a constant (K = 2.22 × 10-1) with cardiac output (CO) and the mean blood pressure (MBP), divided by LV mass (M), and expressed in the unit of W/100 g: CPOM = [K × CO (L/min) × MBP (mmHg)]/LVM(g). Patients were followed-up for the primary endpoint, including all-cause death, ventricular assist device implantation, and heart transplantation, and the secondary endpoint that comprised hospitalization for HF. In multivariate Cox regression analyses, peak CPOM was selected as the most powerful independent predictor of both primary and secondary endpoint [hazard ratio (HR) 0.004, 95% confidence interval (CI) 0.004-0.3; P = 0.002 and HR 0.09, 95% CI 0.02-0.55; P = 0.009]. Sixty-month survival free from the combined endpoint was 85% in those exhibiting oxygen consumption (VO2) > 14 mL/min/kg and peak CPOM > 0.6 W/100 g. Peak VO2 ≤ 14 mL/min/kg provided incremental prognostic value over demographic and clinical variables, brain natriuretic peptide, and resting echocardiographic parameters (χ2 from 58 to 64; P = 0.04), that was further increased by peak CPOM ≤ 0.6 W/100 g (χ2 77; P

Objectives The aim of this study was to investigate the incidence and predictors of early and mid term neurological complications following thoracic endovascular repair (TEVAR) in the Global Registry for Endovascular Aortic Treatment (GREAT). Methods The GREAT is a prospective observational multicentre registry on Gore aortic endografts that was initiated in 2010. Only isolated thoracic aortic pathologies were included (aortic arch and descending thoracic aneurysms, type B dissections, penetrating ulcers, intramural haematomas, pseudoaneurysms, and transections). Thoraco-abdominal aneurysms and concomitant abdominal aneurysms were excluded. Neurological complications were classified as cerebrovascular accidents (CVA) and spinal cord injuries (SCI). Clinical, procedural, and technical data were evaluated for their association with early (30 day) and mid term CVAs and SCIs. Results In total, 833 patients were included: 28 with arch aneurysms (3.4%), 329 with descending thoracic aneurysms (39.5%), 273 with type B dissections (32.8%), and 203 (24.4%) with other thoracic pathologies. Altogether, 593 (71.2%) were elective procedures and 240 (28.8%) were urgent. Aortic coverage >20 cm was performed in 42.1% (n = 351); proximal landing zone 0-1-2 was adopted in 267 patients (32.1%) and of these 98 (36.7%) underwent left subclavian artery (LSA) revascularisation. There were 13 early CVAs (1.5%) and the four year freedom from CVA rate was 96.3%. On multivariable analysis, aortic arch aneurysm was the only independent predictor of early CVA (odds ratio 16.7, p = .001). LSA coverage (hazard ratio [HR] 3.31, p = .005) and hypercholesterolaemia (HR 2.96, p = .024) were independent predictors of mid term ischaemic CVAs. There were 15 (1.8%) early SCIs, and the four year freedom from SCI rate was 97.8%. No independent predictors of early SCI were identified, but length of coverage was an independent predictor of SCI at four years (HR 1.24; p = .044). Conclusions In this real world registry, the overall rate of neurological complication after TEVAR for isolated thoracic aortic pathologies was low. Aortic arch aneurysms were associated with increased peri-operative CVA risk. Length of coverage was an independent predictor of mid term SCIs, as LSA coverage was associated with late CVAs.

To evaluate the treatment efficacy of uterine adenomyosis using MRgFUS as a mini-invasive therapy.Twenty-three patients affected by symptomatic uterine adenomyosis (11 focal and 7 diffuse forms), diagnosed using MRI, were included in this study. Eighteen out of 23 were submitted to MRgFUS. All junctional zone more than 12 mm in width were considered to be adenomyosis. Study evaluates the pre-treatment target volume measured prior to the treatment on the CE T1-weighted sequence and the MRgFUS-treated volume (MRgFUS-TV), represented by the volume of the lesion ablated, measured directly by means of the MRgFUS. The treated volume on the CE T1-weighted sequence (CE MRI-TV) was measured immediately after treatment. After 1 year, the junctional zone thickness was measured in order to compare pre- and post-treatment values. The therapeutic plan consisted of a high-energy-grid sonication. Symptomatology was assessed through the UFS-QOL.The pre-treatment target volume mean value was of 59.7 cc; the MRgFUS-TV had a mean value of 44.9 cc, and the mean value of CE MRI-TV, measured immediately after treatment, was of 52.8 cc, with an increase of 13.7%. The 86.5% of the lesion was treated. After 1 year from the treatment, 15/18 (83%) patients showed thickness of the junctional zone12 mm; 3/18 (17%) had a junctional zone12 mm.MRgFUS is an encouraging mini-invasive treatment for adenomyosis that permits to maintain the integrity of the uterus in a pathology with limited therapeutic possibility.

Evaluate how surgical treatment of benign thyroid disease in elderly people is prone to induce an increase of costs in the next future due to the aging process of the population.A retrospective analysis has been performed on a total of 116 patients operated between January 2007 and September 2011, divided in a group of 58 patients aged over 80 years (Group A) and 58 patients younger than 80 years (Group B). The analyzed data included age, preoperative diagnosis, severe co-morbidities, procedures other than standard needed to evaluate anaesthesiological risk, postoperative hospital stay, complications, duration of postoperative intensive care monitoring, pathologic characteristics, and costs of anaesthesiological risk assessment.Statistical analysis of collected data showed that the costs related to perioperative risk assessment (p value0.001) and the duration of hospital stay (p value0.001) were higher in Group A than in Group B. Instead, surgery-related complications were not statistically different.Despite feasibility and safety of modern surgical techniques, indications for surgery in elderly patients affected by benign thyroid disease should be reserved mainly for those patients with severe medical necessity.

The mechanisms responsible for contribution of variants in the gene TFC7L2 to the risk for type 2 diabetes (T2DM) remains far from being completely understood, and available studies have generated nonunivocal results.We investigated the postprandial glucose metabolism in subjects at risk for T2DM carrying the TCF7L2 risk allele.Twenty-three subjects carrying the risk-conferring TCF7L2 genotypes (11 TT and 12 CT at rs7901346) and 13 subjects with wild-type genotype (CC) underwent a standard mixed-meal test (MMT) in combination with stable isotope tracers.We evaluated endogenous and exogenous glucose fluxes and hormonal responses.Fasting plasma glucose, insulin, C-peptide, glycated hemoglobin, endogenous glucose production, and plasma glucose clearance were similar in the three groups, whereas plasma glucagon levels were lower in both CT and TT than in CC (64 ± 20, 63 ± 18 and 90 ± 29 pg/mL, respectively; both P = .01). In response to the MMT, TT subjects had lower plasma glucose levels than CC subjects [mean area under the time-concentration curve (AUC) 6.1 ± 3.9 vs 7.1 ± 12.0 mmol/L, P = .04] and lower insulin secretion rate (mean AUC 385 ± 95 vs 530 ± 159 pmol/m(2) · min, P = .02). Initial (0-60 min) rate of appearance (Ra) of oral glucose was lower in TT compared with CT/CC (AUC 2.7 ± 1.1 vs 3.8 ± 1.2 μmol/kg · min, P = .02) with no difference among the three groups in endogenous glucose production. The AUC0-60min for Ra of exogenous glucose (Raex) was positively correlated with the plasma glucose AUC0-60min. Total Raex AUC0-120min was correlated with total AUC0-120min of plasma glucose (r = 0.45, P.01). Plasma glucagon-like peptide-1 and glucose-dependent insulinotropic peptide levels in response to the MMT were not affected by genotype.In subjects at risk for T2DM, the TCF7L2 polymorphisms were associated with reduced Raex into systemic circulation, causing reduced postprandial blood glucose increase and, in turn, lower insulin secretion rate with no impairment in β-cell function. The reduced Raex is likely due to greater glucose retention in the splanchnic area.

No data are available on the learning curve in robotic distal pancreatectomy (RADP). The learning curve in RADP was assessed in 55 consecutive patients using the cumulative sum method, based on operative time. Data were extracted from a prospectively maintained database and analyzed retrospectively considering all events occurring within 90 days of surgery. No operation was converted to laparoscopic or open surgery and no patient died. Post-operative complications occurred in 34 patients (61.8%), being of Clavien-Dindo grade I-II in 32 patients (58.1%), including pancreatic fistula in 29 patients (52.7%). No grade C pancreatic fistula occurred. Four patients received blood transfusions (7.2%), three were readmitted (5.4%) and one required repeat surgery (1.8%). Based on the reduction of operative times (421.1 ± 20.5 vs 248.9 ± 9.3 min; p < 0.0001), completion of the learning curve was achieved after ten operations. Operative time of the first 10 operations was associated with a positive slope (0.47 + 1.78* case number; R (2) 0.97; p < 0.0001*), while that of the following 45 procedures showed a negative slope (23.52 - 0.39* case number; R (2) 0.97; p < 0.0001*). After completion of the learning curve, more patients had a malignant histology (0 vs 35.6%; p = 0.002), accounting for both higher lymph node yields (11.1 ± 12.2 vs 20.9 ± 18.5) (p = 0.04) and lower rate of spleen preservation (90 vs 55.6%) (p = 0.04). RADP was safely feasible in selected patients and the learning curve was completed after ten operations. Improvement in clinical outcome was not demonstrated, probably because of the limited occurrence of outcome comparators.

The study aims to assess the risk of cancer in solitary thyroid nodules ≥30 mm in size reported as Bethesda II, and its implications. The clinical records of 202 patients, who underwent thyroid lobectomy for solitary nodules measuring ≥30 mm, reported as Bethesda II on preoperative FNAC between Jan 2015 and Apr 2016 were reviewed. Data collected included nodule size and consistency, and final histopathology results. The risk of cancer and the recommended management according to ATA guidelines were the outcomes of interest. Comparisons were then made between two size categories: (30–40 mm; n = 72; C1) and (>40 mm; n = 130; C2), and two nodule consistencies. Mean nodule size was 43.2 mm (range 30–92). Ninety-five percent were solid and 5% were predominantly cystic. The risk of cancer was 22.8% (46/202) with no size threshold, or graded increase in risk observed. Based on biologic behavior, 50% of cancers were considered clinically significant. Accordingly, the risk of cancer for which surgery is recommended was 11.4% (23/202). The risk of cancer requiring total thyroidectomy was 9.4% and was influenced by nodule size (19 vs. 60% in C1 and C2, respectively; p = 0.01). Predominantly cystic nodules had a greater risk of malignancy compared to predominantly solid nodules even after adjusting for size (40 vs. 9.9%; p = 0.01 and 40 vs. 12.5%; p = 0.02, respectively). The risk of malignancy in Bethesda II solitary nodules ≥30 mm is considerable implying a need for changing the way these are approached and refining cytopathology reporting.

To determine prevalence, spectrum and genotype-phenotype correlations of MUTYH variants in Italian patients with suspected MAP (MUTYH-associated polyposis), a retrospective analysis was conducted to identify patients who had undergone MUTYH genetic testing from September 2002 to February 2014. Results of genetic testing and patient clinical characteristics were collected (gender, number of polyps, age at polyp diagnosis, presence of colorectal cancer (CRC) and/or other cancers, family data). The presence of large rearrangements of the MUTYH gene was evaluated by Multiplex Ligation-dependent Probe Amplification analysis. In all, 299 patients with colorectal neoplasia were evaluated: 61.2% were males, the median age at polyps or cancer diagnosis was 50 years (16-80 years), 65.2% had

Background The independent prognostic impact of diabetes mellitus ( DM ) and prediabetes mellitus (pre‐ DM ) on survival outcomes in patients with chronic heart failure has been investigated in observational registries and randomized, clinical trials, but the results have been often inconclusive or conflicting. We examined the independent prognostic impact of DM and pre‐ DM on survival outcomes in the GISSI ‐HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca‐Heart Failure) trial. Methods and Results We assessed the risk of all‐cause death and the composite of all‐cause death or cardiovascular hospitalization over a median follow‐up period of 3.9 years among the 6935 chronic heart failure participants of the GISSI ‐ HF trial, who were stratified by presence of DM (n=2852), pre‐ DM (n=2013), and non‐ DM (n=2070) at baseline. Compared with non‐ DM patients, those with DM had remarkably higher incidence rates of all‐cause death (34.5% versus 24.6%) and the composite end point (63.6% versus 54.7%). Conversely, both event rates were similar between non‐ DM patients and those with pre‐ DM . Cox regression analysis showed that DM , but not pre‐ DM , was associated with an increased risk of all‐cause death (adjusted hazard ratio, 1.43; 95% CI , 1.28–1.60) and of the composite end point (adjusted hazard ratio, 1.23; 95% CI , 1.13–1.32), independently of established risk factors. In the DM subgroup, higher hemoglobin A1c was also independently associated with increased risk of both study outcomes (all‐cause death: adjusted hazard ratio, 1.21; 95% CI , 1.02–1.43; and composite end point: adjusted hazard ratio, 1.14; 95% CI , 1.01–1.29, respectively). Conclusions Presence of DM was independently associated with poor long‐term survival outcomes in patients with chronic heart failure. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 00336336.

The study explores the degree of control of hyperglycaemia and cardiovascular (CV) disease risk factors in men and women with type 2 diabetes and the impact thereon of obesity, central adiposity, age and use of medications.A cross-sectional survey was conducted at 10 hospital-based outpatients diabetes clinics. 1297 men and 1168 women with no previous CV events were studied. Women were slightly (only one year) older and more obese than men: average BMI was respectively 30.7 ± 5.7 vs 28.6 ± 4.1 kg/m(2) (p0.001), and prevalence of abdominal obesity was 86% vs 44% (p0.001). Women smoked less, but had higher HbA1c, LDL cholesterol, non-HDL cholesterol, systolic blood pressure and serum fibrinogen than men. Accordingly optimal targets for HbA1c (7%), LDL cholesterol (100 mg/dL), HDL cholesterol (40 for men,50 for women, mg/dL), and systolic blood pressure (130 mmHg) were less frequently achieved by women than men (respectively 33.8% vs 40.2%; 14.6% vs 19.2%; 34.1% vs 44.5%; 68.8% vs 72%; p0.05 for all). Findings were confirmed after stratification for waist circumference (or ≥ 88 cm for women;or ≥ 102 cm for men), BMI (or ≥ 25 kg/m(2)) or age (or ≥ 65 years). As for treatment, women were more likely than men to take insulin, alone or in combination with oral hypoglycaemic drugs, to be under anti-hypertensive treatment, whereas the use of lipid lowering drugs was similar in men and women.Control of hyperglycaemia and major CVD risk factors is less satisfactory in women than men. The gender disparities are not fully explained by the higher prevalence of total and central obesity in women; or by a less intensive medical management in women.

Background Proton magnetic resonance spectroscopy of operative specimens has been reported to successfully differentiate normal tissue from malignant thyroid tissue. We used a new high-resolution magnetic resonance spectroscopy technique for the differentiation of benign and malignant thyroid neoplasms. Methods Histological specimens from 72 patients undergoing a total thyroidectomy were processed into a 4-mm ZrO 2 high-resolution magic angle spinning (HRMAS) rotor with 5 μL of D 2 O. A Bruker Avance spectrometer operating at 400 MHz for the 1 H frequency and equipped with a 1 H/ 13 C/ 31 P HRMAS probe was used. Results Normal and neoplastic thyroid tissues could be discriminated from each other by different relative concentrations of several amino acids and lipids, as well as benign and malignant neoplasms, that differed in terms of a greater lactate and taurine and a lesser lipid choline, phosphocholine, myo-inositol, and scyllo-inositol levels in malignant samples. A statistical analysis with a receiver operating characteristic curve revealed that 77% of the samples were accurately predicted. Similar results were obtained with specimens obtained from ex vivo aspirates. Conclusion A further development of this project will be to use the metabolomics approach on specimens obtained from aspirates in vivo after the resolution of technical problems attributable to possible contamination.

The paper presents a post-hoc analysis of the intensity of dyslipidaemia care operated in the first 2 years of Multiple-Intervention-in-type-2-Diabetes.ITaly (MIND.IT) study.MIND.IT is a multicentric, randomized, two-parallel arm trial involving 1461 type 2 diabetic patients at high cardiovascular (CV) risk. The study compares the usual care (UC) of CV prevention with a multifactorial intensive care (IC) approach aiming at achieving target values for the main CV risk factors according to a step-wise treat-to-target approach.Proportion of patients on target for low-density lipoprotein cholesterol (LDL-C) was about 10% at baseline and increased significantly more with IC than UC (43 vs. 27%; p 0.001). However, the majority (57%) of patients, in this intended intensively treated cohort, failed to achieve the proposed target. Average LDL-C decreased from 144 ± 35 to 108 ± 31 mg/dl with IC and from 142 ± 28 to 118 ± 32 with UC (p-for-interaction0.0001). IC was associated with a significantly greater increase in statin prescription and lower withdrawal from treatment than UC (43 vs. 11% and 28 vs. 61%, respectively; both p 0.001). However, the new treatments were characterized in both groups by the use of low starting doses (≤ 10 mg of atorvastatin, equivalent dose in more than 90% of patients) without increase in case of missed target.The application of a multifactorial treat-to-target intervention is associated with a significant improvement in LDL-C beyond usual practice. However, the change in LDL-C appears to be more related to an increased number of treated patients and a decreased treatment withdrawal than to a true treat-to-target approach.

Background and Aim: We evaluated the relationship between insulin resistance (IR) and insulin secretion with the metabolic syndrome (MS) in 885 subjects (377 men/508 women, age 49 11 years, BMI 29 5.2 kgm2) at risk of diabetes enrolled in the genetics, pathophysiology and evolution of type 2 diabetes (GENFIEV) study. Methods and Results: All subjects underwent a 75-g oral glucose tolerance test (OGTT) for the estimation of plasma levels of glucose and C-peptide, as well as fasting insulin and lipid profile. IR was arbitrarily defined as HOMA-IR value above the 75th centile of normal glucose tolerance (NGT) subjects. Overall MS prevalence (National Cholesterol Treatment Panel-Adult Treatment Panel (NCEP-ATPIII) criteria) was 33%, 19% in subjects with NGT, 42% in impaired fasting glucose (IFG), 34% in impaired glucose tolerance (IGT), 74% in IFG + IGT subjects, and 56% in newly diagnosed diabetic patients. Prevalence was slightly higher with IDF criteria. MS prevalence was >50% in subjects with 2 h glucose >7.8 mmol l-1, independently of fasting plasma glucose. IR prevalence was higher in subjects with MS than in those without (63% vs. 23%; p < 0.0001) and increased from 54% to 73% and 88% in the presence of three, four or five traits, respectively. IR occurred in 42% of subjects with non-diabetic alterations of glucose homeostasis, being the highest in those with IFG + IGT (IFG + IGT 53%, IFG 45%, IGT 38%; p < 0.0001). Individuals with MS were more IR irrespective of glucose tolerance (p < 0.0001) with no difference in insulinogenic index. Hypertriglyceridaemia (OR: 3.38; Confidence Interval, CI: 2.294.99), abdominal obesity (3.26; CI: 2.18-4.89), hyperglycaemia (3.02; CI: 1.80-5.07) and hypertension (1.69; CI: 1.12-2.55) were all associated with IR. Conclusions: These results show that in subjects with altered glucose tolerance (in particular IFG + IGT) MS prevalence is high and is generally associated to IR. Some combinations of traits of MS may significantly contribute to identify subjects with IR.

The error in medicine has long been discussed in scientific debates. The purpose of this study is to evaluate the degree knowledge, attitude and behavior of students in Nursing for the failure in the health sector.It was administered to 231 students of Nursing of the Sapienza University of Rome (171 females and 60 males), aged between 21 and 45 years, a structured questionnaire in three questions that explore the experiences and opinions about the errors found in medical practice, the causes underlying them and the mistakes that should never be committed. Data were collected, stratified by sex, age, marital status, and analyzed using the χ2 test. Significance was set at p≤0.05.The 5 errors found more frequently in clinical practice by the students were the following: Errors that favors the onset of hospital infections (58.9%); Non adherence to protocols (50.2%); Patient care (45.9%); Errors due to the administration of therapies and drugs (45.9%); Errors relating to the execution of withdrawals (35.9%). The five cases considered most frequently responsible for such errors were: the rush (70.1%), followed by neglect / superficial (55%); disorganization (51.5%); not hygienically / infertility (50.6%) and inattention (42.9%). With regard to the errors that you should never commit, students have shown more frequently: the errors of administration of therapies / medications (69.3%); errors of prescription therapies / medications (58.9%); errors related to surgery (52.8%); the exchange of patient or misidentification of the patient (50.6%); errors that favor the occurrence of hospital infections (48.1%).The results of this study shows the importance of a culture of error in medicine, also as part of undergraduate education, in order to train and educate future health professionals to this issue in order to promoting patient safety and quality of health.INTRODUZIONE. L’errore in medicina è da sempre oggetto di discussione nei dibattiti scientifici. Scopo del presente studio è quello di valutare il grado conoscenza, attitudine e comportamenti degli studenti in Infermieristica in relazione all’errore in ambito sanitario. METODI. E’ stato somministrato a 231 studenti di Infermieristica della Sapienza Università di Roma (171 femmine e 60 maschi), con un’età compresa tra 21 e 45 anni, un questionario strutturato in tre domande che indagano le esperienze e le opinioni circa gli errori riscontrati nella pratica medica, le cause sottostanti ad essi e gli errori che non andrebbero mai commessi. I dati sono stati raccolti, stratificati per sesso, età, stato civile, e analizzati con il test χ2. La significatività è stata fissata a p≤0.05. RISULTATI. I 5 errori riscontrati più frequentemente nella pratica clinica da parte degli studenti sono risultati i seguenti: Errori che favoriscono l’insorgenza di infezioni ospedaliere (58.9%); Non aderenza ai protocolli (50.2%); Assistenza al paziente (45.9 %); Errori dovuti alla somministrazione di terapie e farmaci (45.9 %); Errori relativi all'esecuzione di prelievi (35.9%). Le cinque cause ritenute più frequentemente responsabili di tali errori sono risultate: la fretta (70.1%), seguita da negligenza/superficialità (55%); disorganizzazione (51.5%); non rispetto delle norme igieniche/sterilità (50.6%) e disattenzione (42.9%). Relativamente agli errori che non si dovrebbero mai commettere, gli studenti hanno indicato con maggiore frequenza: gli errori di somministrazione di terapie/farmaci (69.3%); gli errori di prescrizione di terapie/farmaci (58.9%); gli errori relativi agli interventi chirurgici (52.8%); lo scambio di paziente o errata identificazione del paziente (50.6%); gli errori che favoriscono l’insorgenza di infezioni ospedaliere (48.1%). CONCLUSIONI. Dai risultati di questo studio emerge l’importanza di una cultura dell’errore in medicina, anche nell’ambito della formazione undergraduate, al fine di formare e sensibilizzare i futuri operatori sanitari a tale problematica promuovendo la sicurezza dei pazienti e la qualità dei servizi sanitari.