The PRESTO study: awareness of stroke symptoms and time from onset to intervention.

Timely access to medical assistance is the first crucial step to improving clinical outcomes of stroke patients. Many educational campaigns have been organized with the purpose of making people aware of what a stroke is and what is necessary to do after its clinical onset. The PRESTO campaign was organized in Genoa (Italy) to spread easy messages regarding the management of the acute phase of stroke. Educational material was disseminated to educate people to call the emergency medical services as soon as symptoms appear. Data collected were analyzed in three different phases of the campaign: before the beginning, during, and after the end. We enrolled 1,132 patients with ischemic stroke admitted to hospital within 24 hours of symptoms onset. Our data showed a mild reduction in onset-to-door time (24 minutes) during the months following the end of the campaign and a slight increase in number of patients who arrived at hospitals, in particular with milder symptoms and transient ischemic attack, as opposed to the same period before the campaign. Interestingly, in the months after the end of the campaign, we observed a slight reduction of the percentage of patients who accessed hospitals after 4.5 hours from symptoms onset. In conclusion, our results may suggest that an informative campaign can be successful in making people rapidly aware of stroke onset, with the consequent rapid access to hospitals. Considering the changing of way of access to information, we think that an extensive multimedia campaign should be evaluated in the next future.

Clinicopathologic and Dermoscopic Features of 20 Cases of Spark's Nevus, a Dermoscopic Simulator of Melanoma.

ABSTRACT: Spark's nevus is a particular type of melanocytic nevus, with histology that shows features of both Spitz and Clark nevus. Detailed dermoscopic features in a series of Spark nevi have not been described yet. We performed a monocentric retrospective observational study on 20 lesions of Spark nevus excised from 19 patients (M:F = 10:9; mean age: 37,6 years), reviewed by 5 experts in dermoscopy and 2 dermatopathologists. A histologic review confirmed that Spark nevi were mostly symmetric (80%), well circumscribed (100%), mainly compound (65%) melanocytic lesions with either epithelioid (55%) or spitzoid (45%) cell morphology and bridging of the nests (100%). Spark nevi were more frequently found on the trunk (85%) in patients with a history of sunburns in childhood (84%), with skin phototype III (79%), and with high nevus count (>100 nevi, 7 patients (36%)). On dermoscopy, we observed different general patterns: multicomponent (40%), reticular-globular-homogeneous (15%), globular homogeneous (15%), reticular (15%), reticular-globular (5%), homogeneous (5%), and globular (5%). Spark nevi showed frequently dermoscopic asymmetry (63%), brown color (90%) with areas of central hyperpigmentation (41%) and peripheral hypopigmentation (28%), atypical pigment network (48%), irregular globules (42%), irregular dots (31%), irregular blotches (16%), blue-whitish veil (13%), peripheral island (25%), irregular hyperpigmented areas (12%), and regression (33%). BRAF mutation was present in 7 of the 10 analyzed cases (70%); all these cases presented a history of evolution. In conclusion, Spark nevi occur on the trunk of young adults with high nevus count and history of sunburns; dermoscopic features are protean, often atypical and suspicious of melanoma.

Prognostic value of texture analysis of the primary tumour in high-risk neuroblastoma: An 18 F-DOPA PET study.

PURPOSE: To evaluate the prognostic value of texture analysis of the primary tumour with 18 fluorine-dihydroxyphenylalanine positron emission tomography/X-ray computed tomography (18 F-DOPA PET/CT) in patients affected by high-risk neuroblastoma (HR-NBL). METHODS: We retrospectively analysed 18 patients with HR-NBL, which had been prospectively enrolled in the course of a previous trial investigating the diagnostic role of 18 F-DOPA PET/CT at the time of the first onset. Texture analysis of the primary tumour was carried out on the PET images using LifeX. Conventional indices, histogram parameters, grey level co-occurrence (GLCM), run-length (GLRLM), neighbouring difference (NGLDM) and zone-length (GLZLM) matrices parameter were extracted; their values were compared with the overall metastatic load, expressed by means of whole-body metabolic burden (WBMB) score and the progression-free/overall survival (PFS and OS). RESULTS: There was a direct correlation between WBMB and radiomics parameter describing uptake intensity (SUVmean : p = .004) and voxel heterogeneity (entropy: p = .026; GLCM_Contrast: p = .001). Conversely, texture indices of homogeneity showed an inverse correlation with WBMB (energy: p = .026; GLCM_Homogeneity: p = .006). On the multivariate model, WBMB (p < .01) and the first standardised uptake value (SUV) quartile (p < .001) predicted PFS; OS was predicted by WBMB and the N-myc proto-oncogene protein (MYCN) amplification (p < .05) for both. CONCLUSIONS: Textural parameters describing heterogeneity and metabolic intensity of the primary HR-NBL are closely associated with its overall metastatic burden. In turn, the whole-body tumour load appears to be one of the most relevant predictors of progression-free and overall survival.

Internal carotid artery dissection related to abnormalities of styloid process: is it only a matter of length?

INTRODUCTION: Vascular Eagle syndrome, due to impingement of the extracranial internal carotid artery (ICA) by the styloid process (SP), is an uncommon and not yet widely recognized cause of ICA dissection. Up to now, this diagnosis is still presumptive, based mainly on the length of the SP. However, given the discrepancy between the much higher prevalence of an elongated SP in the population compared to the reported rate of Eagle syndrome, other anatomical factors beyond the length itself of this bony structure seem to be involved. MATERIAL AND METHODS: We performed a retrospective single center case-control study of ICA dissection related to abnormalities of styloid process and age- and sex-matched controls affected by ICA dissection not related to abnormal relationship with the styloid process. In our work instead of considering SP length as the main criteria to differentiate the two groups, we decided to consider styloid process-internal carotid artery distance (at the dissection point) as the main factor to define a styloid process related dissection (SPRD). In fact in some patients, the distance between the dissected artery and the bony prominence was virtual. RESULTS: Our study showed that in patients with SPRD the styloid process angulation on the coronal plane tends to be more acute and that styloid process-C1 distance is significantly shorter at the side of the dissection. This data reinforces the idea that ICA dissection risk in the vascular Eagle syndrome has probably a multifactorial pathogenesis.

Head CT in centenarians: emergency and non-emergency findings.

INTRODUCTION: Our retrospective study evaluates head CTs performed in our Hospital in the last 11 years (2009-2019) in centenarian patients. OBJECTIVES: To estimate the correlation between reasons for examination and CT findings in emergency and to evaluate if there was the expected involution of the brain by analyzing some non-emergency neuroradiological parameters (NENP). MATERIAL AND METHODS: 62 Head CTs performed on patients aged 100 and over were reviewed. They were evaluated emergency CT findings and NENP (leukoencephalopathy, enlargement of the ventricular volume, presence of vascular calcifications). For comparison, NENP were also assessed in two relatively younger populations of 62 patients aged between 65-70 (called "65-70") and 85-90 ("85-90"). RESULTS: In cases of suspected traumatic brain lesions, 11.9% (n = 5/42) of centenarians showed a cerebral bleeding; as concerns suspected stroke we found a higher concordance between clinical suspicion and CT features, 46.6% (n = 7/15). As regards NENP, no significant differences were found with respect to the "85-90" population in terms of severity of leukoencephalopathy, enlargement of the ventricular volume and presence of vascular calcifications. CONCLUSIONS: In emergency, CT plays a pivotal role in defining an immediate diagnosis and from a medico-legal point of view, resulting together with clinical observation the main strategy in the management of centenarians. By the analysis of NENP we may support that centenarians' brains on CT are similar to those of "85-90".

How to better stratify the risk of differentiated thyroid carcinomas: the key role of radioactive iodine therapy, age, and gender.

PURPOSE: The risk of relapse of differentiated thyroid carcinomas (DTC) and their indication for radioactive iodine therapy (RAI) are assessed according to ATA risk stratification system principally based on tumor-nodes-metastasis (TNM) staging. However, while establishing the indication for RAI may be a "dilemma," performing it can improve the risk stratification. We aimed to evaluate whether (1) the stratification of risk of recurrence differs when TNM is considered with or without peri-RAI findings and (2) the assessment of the risk of disease-specific mortality is improved by adding age and gender. METHODS: From our database, all DTC patients treated with thyroidectomy and RAI from 1992 to 2017 were included. Subjects with a follow-up shorter than 1 year and positive thyroid antibodies were excluded. Patients were classified into (1) a three-category ATA model based on TNM (basic model) and (2) a five-category model based on TNM plus peri-RAI findings, i.e., thyroglobulin and 131I whole-body scan (advanced model). Relapse was proven by histology and/or imaging. Differences in disease-free survival (DFS) and overall survival (OS) were assessed. RESULTS: We enrolled 907 patients; of these, 4.4% died and 21% suffered recurrence. According to the basic model, there were 11.8% high-risk, 32.9% intermediate-risk, and 55.3% low-risk patients. According to the advanced model, 29.9% of patients were re-classified in a higher risk category and the five categories of this model displayed significantly different risks of relapse and death. The estimate of DFS was significantly higher in the advanced model than in the basic one (ΔC-index = + 6.8%, P < .001). By adding age and gender to the advanced model, the highest performance in predicting death was achieved (ΔC-index = + 5.1%, P < .001). CONCLUSIONS: The peri-RAI findings are essential in order to carefully stratify the risk of DTC recurrence. Integrating these data with age and gender enables those cases at highest risk of death to be identified.

Multidimensional prognostic index (MPI) predicts successful application for disability social benefits in older people.

AIM: The economic recognition of disability is of importance in daily practice, but the tools used in older people are still limited. Therefore, we aimed to investigate the effectiveness of the multidimensional prognostic index (MPI) to identify frail older subjects to be submitted to civil invalidity application for disability benefits including Attendance Allowance (AA) indemnity, Carer's Leave (Law 104) and/or Parking Card for people with disabilities. METHODS: From March 2018 to January 2019, 80 older people were included. The MPI was calculated from comprehensive geriatric assessment information including eight different domains. Civil benefits included attendance allowance (AA) indemnity by the Local Medico-Legal Committee (MLC-NHS) and by the National Institute of Social Security Committee (INPS), Carer's Leave (Law 104), and Parking Card for people with disabilities. RESULTS: MPI values were associated with an increased probability to obtain a 100% civil disability, AA indemnity, Carer's Leave and a parking card for people with disabilities. MPI score showed a very good accuracy in predicting the civil invalidity benefits with a area-under-curve (AUC) of 87.3 (95% CI 80.6-97.4) to predict the release of AA indemnity, 81.3 (95% CI 68.5-91.1) to predict Care's leave and 70.7 (95% CI 59.4-84.7) to predict the Parking Card release. Moreover, data showed that a cut-off score of MPI ≥ 0.75 could identify the 100% of older subjects who successfully obtained the indemnity release. CONCLUSION: MPI is an excellent predictor of social benefits' release by local and national agencies.

A Presurgical Study of Curcumin Combined with Anthocyanin Supplements in Patients with Colorectal Adenomatous Polyps.

Adenomatous polyps are precancerous lesions associated with a higher risk of colorectal cancer (CRC). Curcumin and anthocyanins have shown promising CRC-preventive activity in preclinical and epidemiological studies. The objective of this window-of-opportunity, proof-of principle trial was to evaluate the effect of curcumin combined with anthocyanin supplements on tissue biomarkers of colorectal adenomatous polyps. Eligible patients received either anthocyanin and curcumin supplementation or related matching placebo for 4-6 weeks before polyp removal. Adenomatous polyps and adjacent tissue biopsies were collected at baseline and after supplementation for immunohistochemical assessment of ß-catenin, NF-kappa B (NF-κB), Ki-67, P53, and dysplasia. No differences were observed in baseline biomarker expression between normal and dysplastic tissues. The combination of anthocyanins and curcumin resulted in a significant borderline reduction of NF-κB immunohistochemistry (IHC) expression in adenoma tissue (geometric mean ratio (GMR): 0.72; 95% confidence interval (CI): 0.51-1.00; p-value: 0.05) and a trend to a reduction of Ki-67 (GMR: 0.73; 95% CI: 0.50-1.08; p-value: 0.11). No significant modulation of biomarkers in normal adjacent mucosa was observed. We concluded that the combined supplementation of anthocyanins and curcumin seems to lead to a potentially favorable modulation of tissue biomarkers of inflammation and proliferation in colon adenomas.

Pharmacokinetics, safety, and activity of trabectedin as first-line treatment in elderly patients who are affected by advanced sarcoma and are unfit to receive standard chemotherapy: A phase 2 study (TR1US study) from the Italian Sarcoma Group.

BACKGROUND: Although elderly patients (≥70 years) represent 30% of new diagnoses of soft tissue sarcoma (STS), they are underrepresented in clinical trials and are often unfit to receive standard anthracycline-based chemotherapy. Trabectedin is registered as a second-line treatment for advanced STS and is characterized by a favorable safety profile. METHODS: The aim of this single-arm, phase 2 study was to investigate trabectedin (scheduled dose, 1.3-1.5 mg/m2 ) as a first-line treatment in elderly patients with advanced stage STS who are inoperable and are unfit to receive standard anthracycline-based chemotherapy. The coprimary endpoints were progression-free survival at 3 months (PFS3) and the rate of clinically limiting toxicities (CLTs). We also conducted an ancillary study on pharmacokinetics. RESULTS: Twenty-four patients (12 men and 12 women) with a median age of 79 years (interquartile range [IQR], 74-83 years) were enrolled. The histological subtype was leiomyosarcoma in 46%, liposarcoma in 33%, and other histotypes in 21%. The median number of trabectedin courses was 4 (IQR, 3-6), with 7 patients (29%) receiving ≥6 cycles. Eight patients (33%) required dose reductions. The most frequent grade 3/4 adverse events were neutropenia in 9 patients (38%), fatigue in 5 patients (21%), and aminotransferase elevation in 5 patients (21%). PFS3, median PFS, and overall survival were 71% (80% CI, 57%-81%), 4 months, and 12 months, respectively. Ten patients (42% [80% CI, 28%-57%]) experienced CLTs. Trabectedin Cmax , half-life, clearance, and distribution volume were 1.28 ng/mL (standard deviation [SD], 0.58 ng/mL), 26.70 hours (SD, 9.09 hours), 39.98 L/h/m2 (SD, 14.08 L/h/m2 ), and 1460 L/m2 (SD, 561 L/m2 ), respectively. CONCLUSION: Trabectedin can be administered safely to elderly patients with STS who are unfit to receive anthracyclines. Pharmacokinetics in the elderly population was superimposable to historical data.

The prognostic significance of geriatric syndromes and resources.

BACKGROUND: Geriatric syndromes (GS) do not fit into discrete disease categories and are often underdiagnosed in hospitalized older adults. Geriatric resources (GR) are also not routinely collected in clinical settings, although this may potentiate the beneficial effects of clinical decisions. The prognostic relevance of GS and GR has never been systematically evaluated through clinical tools developed for clinical decision purposes. AIM: To ascertain the impact of common GS and GR on patients' prognosis as assessed by means of the comprehensive geriatric assessment (CGA)-based Multidimensional Prognostic Index (MPI). METHODS: One hundred and thirty-five hospitalized patients aged 70 years and older underwent a CGA evaluation with calculation of the MPI on admission and discharge. Accordingly, patients were subdivided in low (MPI-1, score 0-0.33), moderate (MPI-2, score 0.34-0.66), and severe (MPI-3, score 0.67-1)-risk of mortality at 1 month and 1 year. Nine GR and 17 GS were identified and collected accordingly. RESULTS: A lower number of GS and a higher number of GR were shown to be highly significantly correlated with a lower MPI, as well as years of education, grade of care, and number of medications independent of age, sex and number of GS or GR. Underweight and obesity according to the BMI were significantly correlated to higher number of GS. Patients with more GR had a significantly higher chance of being discharged home. CONCLUSIONS: The MPI evaluation together with GS and GR in acute care for older patients should be encouraged to improve clinical decision-making.

Aromatase Inhibitors as Adjuvant Treatment for ER/PgR Positive Stage I Endometrial Carcinoma: A Retrospective Cohort Study.

OBJECTIVE: Although endometrial cancer (EC) is a hormone dependent neoplasm, there are no recommendations for the determination of steroid hormone receptors in the tumor tissue and no hormone therapy has ever been assessed in the adjuvant setting. The purpose of this study was to explore the effect of adjuvant aromatase inhibitors (AIs) on progression-free survival (PFS) and overall survival (OS) in patients with early stage and steroid receptors-positive EC. METHODS: We retrospectively analyzed clinical and pathological factors in 73 patients with high-risk (49.3%) or low-risk (50.7%) stage I (n = 71) or II (n = 2) endometrial cancer who received by their preference after counseling either no treatment (reference group) or AI. Prognostic factors were well balanced between groups. Expression of estrogen receptor (ER), progesterone receptor (PgR), and Ki-67 index was correlated with clinical outcomes. RESULTS: Univariate and multivariate Cox proportional regression analyses, adjusted for age, grade, stage, depth of myometrial invasion, lymphovascular space invasion, BMI, ER, PgR and Ki-67 labeling index levels, showed that PFS and OS had a trend to be longer in patients receiving AI than in the reference group HR= 0.23 (95% CI; 0.04-1.27) for PFS and HR= 0.11 (95% CI; 0.01-1.36) for OS. CONCLUSION: Compared with no treatment, AI exhibited a trend toward a benefit on PFS and OS in patients with early stage hormone receptor-positive EC. Given the exploratory nature of our study, randomized clinical trials for ER/PgR positive EC patients are warranted to assess the clinical benefit of AI and the potential predictive role of steroid receptors and Ki-67.

A Prospective Intervention Trial on Tailored Radiofrequency Ablation of Uterine Myomas.

Background and Objective: Investigating the use of radiofrequency myolysis (RFM) for the treatment of fibroids through less invasive access by combining transvaginal ultrasound, hysteroscopy and laparoscopy. Materials and Methods: Fifty-four premenopausal women with 106 symptomatic uterine myomas. Patients underwent RFM in three ways: Vaginal Ultrasound-guided RFM (VU-RFM), Laparoscopic RFM (L-RFM) and Hysteroscopic-RFM (H-RFM). The mean patient age was 43 years; 52 symptomatic uterine myomas were subserosal, 44 intramural and 10 submucosal. The outcomes evaluated at 1 and 12 months after RFM were myoma size (volume-diameter), "Uterine Fibroid Symptom and Quality of Life (UFS-QOL)" questionnaire and a 10-point Visual Analogue Scale (VAS). The therapy was completed with a single ablation in all patients, no complication was registered. The average number of fibroids treated per intervention was two with the use of different accesses: 64/106 VU-RFMs (60.4%), 32/106 L-RFMs (30.2%) and 10/106 H-RFMs (9.4%). Results: Volume and diameter of fibroids were significantly reduced by, respectively, 51.3% and 20.1% in the first 30 days post-intervention (p < 0.001) up to a maximum of 73.5% and 37.1% after the second follow-up visit at 12 months (p < 0.001). A similar trend was shown in terms of disability with a progressive and significant reduction of symptoms (menorrhagia, dysmenorrhea, dyspareunia and pollakiuria) demonstrated by percentage variation of UFS-QOL Symptom Severity and VAS scores to -74.3% and -45.3% as well as -84.9% and -74.3%, respectively, at 1 and 12 months after RFM (p < 0.001). An overall improvement in the quality of life was also demonstrated by a significant increase in the UFS-QOL total score of +38.2% in the first 30 days post-intervention up to +44.9% after the second follow-up visit at 12 months (p < 0.001). The overall average surgery time of the RFM for each patient was 48 minutes, and the time to treat each fibroid by Vaginal Ultrasound-guided RFM (23 min) was found to be significantly less than those of laparoscopy or hysteroscopy (respectively 35 and 34 min) (p < 0.05). An electromagnetic virtual needle tracking system (VNTS) was successfully tested during the RFM procedures, and real-time contrast-enhanced ultrasound (CEUS) has proven to be effective in determining the duration of myolysis through the identification of eventual residual areas of enhancement within the fibroids. Conclusion: Radiofrequency can be considered a minimally invasive and safe procedure for the treatment of uterine myomas through the customization and possible combination of transvaginal, laparoscopic or hysteroscopic accesses. The standardization of the ablation technique with pre-intervention biopsy and new technologies such as VNTS and CEUS spares healthy uterine tissue and may change the future management of symptomatic uterine fibroids.

The Multidimensional Prognostic Index in general practice: One-year follow-up study.

BACKGROUND: Older patients' health problems in general practice (GP) can often not be assigned to a specific disease, requiring a paradigm shift to goal-oriented, personalised care for clinical decision making. PURPOSE: To investigate the predictive value of the comprehensive geriatric assessment (CGA)-based Multidimensional Prognostic Index (MPI) in a GP setting with respect to the main healthcare indicators during the 12 months following initial evaluation. METHODS: One hundred twenty-five consecutive patients aged 70 years and older were enrolled in a GP and followed up to one year. All patients underwent a CGA based on which the MPI was calculated and subdivided into three risk groups (MPI-1, 0-0.33 = low risk, MPI-2, 0.34-0.66 = moderate risk and MPI-3, 0.67-1, severe risk). Grade of Care (GC), hospitalization rate, mortality, nursing home admission, use of home care services, falls, number of general practitioner contacts (GPC), of geriatric resources (GR) and geriatric syndromes (GS) during the 12 months following initial evaluation were collected. RESULTS: The MPI was significantly associated with number of GS (P < .001), GR (P < .001), GC (P < .001) as well as with the average number of GPC per year (mean 10.4, P = .046). Interestingly, the clinical judgement of the general practitioner, in this case knowing his patients for 16 years on average, was associated with adverse outcomes to a similar extent than the prediction offered by the MPI (GP/adverse outcomes and MPI/adverse outcomes P < .001). CONCLUSION: The MPI is strongly associated with adverse outcomes in older GP patients and strongly predicts the number of GPC up to one year after initial evaluation. Considering the feasibility and the strong clinimetric properties of the MPI, its collection should be encouraged as early as possible to disclose risk conditions, implement tailored preventive strategies and improve cost-effectiveness of healthcare resources use.

New associations of the Multidimensional Prognostic Index.

BACKGROUND: The multidimensional prognostic index (MPI) is a validated, sensitive, and specific prognosis estimation tool based on a comprehensive geriatric assessment (CGA). The MPI accurately predicts mortality after 1 month and 1 year in older, multimorbid patients with acute disease or relapse of chronic conditions. OBJECTIVE: To evaluate whether the MPI predicts indicators of healthcare resources, i.e. grade of care (GC), length of hospital stay (LHS) and destination after hospital discharge in older patients in an acute medical setting. MATERIAL AND METHODS: In this study 135 hospitalized patients aged 70 years and older underwent a CGA evaluation to calculate the MPI on admission and discharge. Accordingly, patients were subdivided in low (MPI­1, score 0-0.33), moderate (MPI-2, score 0.34-0.66) and high (MPI-3, score 0.67-1) risk of mortality. The GC, LHS and the discharge allocation were also recorded. RESULTS: The MPI score was significantly related to LHS (p = 0.011) and to GC (p < 0.001). In addition, MPI-3 patients were significantly more often transferred from other hospital settings (p = 0.007) as well as significantly less likely to be discharged home (p = 0.04) than other groups. CONCLUSION: The CGA-based MPI values are significantly associated with use of indicators of healthcare resources, including GC, LHS and discharge allocation. These findings suggest that the MPI may be useful for resource planning in the care of older multimorbid patients admitted to hospital.

Physical Activity, Bleedings and Quality of Life in Subjects with Haemophilia A without Inhibitors-A Multicenter, Observational Italian Study with a Wearable Device.

Background: This study aimed to gather data on physical activity (PA), bleeding, health-related quality of life, and health status, using a wearable device and an electronic patient-reported outcome (ePRO) app, in individuals with moderate or severe hemophilia A (HA) without inhibitors receiving treatment according to the clinical practice. Methods: This is a 12-month multicenter cohort study conducted in Italy. The primary outcomes included the description of PA by type and intensity, adherence to World Health Organization guidelines, bleeding, and health-related quality of life by EQ-5D questionnaire. PA data were collected continuously through a fitness tracker worn by the patient; all the other variables were collected through ePRO questionnaires. Results: Only 54 of the 103 enrolled subjects (52.4%) used their fitness tracker for the defined valid period; adolescents were the least compliant age group. PA was performed at low rates and intensity. Approximately 52% of the subjects had sedentary behavior. The mean EQ-5D values did not change over time. At least one bleeding was reported in 43.7% of the subjects, mostly with sedentary behavior. The PA in the 2 days preceding the bleeding was comparable to the one observed in the overall observational period. Conclusions: The systematic recording of data through a fitness tracker and ePRO app shows that subjects with HA without inhibitors have lower-than-expected PA and that they still experience issues related to bleeding.

Safety and Performance of POLYTECH Mesmo Breast Implants: A 5-Year Post-market Surveillance Study on 919 Patients.

Background: In 2007, POLYTECH Health & Aesthetics (POLYTECH, Dieburg, Germany) established an ongoing patient survey to improve the post-market surveillance of silicone gel-filled breast implants based on patient-reported outcomes in the context of the pioneering "Implants of Excellence" (IoE) program. Objectives: To disclose an update on safety and performance outcomes at 5 years for Mesmo breast implants. Methods: Between January 2014 and October 2019, 919 patients (for a total of 1816 implants) who underwent breast augmentation and reconstruction with Mesmo implants were asked to participate in the IoE program. Data were collected by mean of 1320 questionnaires received. A survival analysis assessed the onset of different complications. Results: Eight patients (0.9%) experienced capsular contracture Baker grade III or IV with a cumulative rate at 5 years of 1.2% (95% CI = 0.6-2.4). The proportion of revisional surgery was 0.5% with a 5-year rate of 0.6% (95% CI = 0.2-1.5). Additional adverse events such as hematoma, seroma, malposition, open wounds, and other complications were carefully monitored. Questionnaires showed that 93.9% (95% CI = 92.2-95.4) of the patients were satisfied or very satisfied with their aesthetic results with Mesmo implants. Conclusions: Post-market clinical follow-up revealed that the overall complications rate reported was low. Data demonstrated an excellent safety property on a large cohort of patients. This result allows the rating of Mesmo breast implants as highly competitive and a very safe choice for both surgeons and patients.

Effect of sex on psychological distress and fatigue over time in a prospective cohort of cancer survivors.

BACKGROUND: Studies indicate a higher level of distress in women than men with cancer, but whether this difference is retained over time is unknown. We studied the frequency and level of distress and fatigue during time according to gender in a cohort of cancer survivors. PATIENTS AND METHODS: In this prospective study, cancer survivors were invited to undergo a psychological session immediately before the medical visit. Distress was assessed by the distress thermometer, and fatigue was assessed by the ESAS-r scale. Patients underwent follow-up visits to assess changes over time. RESULTS: A total of 305 patients and 568 visits were performed with a median follow-up of 15.8 months. At baseline, females, young age, and breast cancer patients had significantly higher distress. However, there was an increase in distress of 0.29 points every 6 months in males (95% CI, 0.09-0.50) versus no change in females (0.03 points, 95% CI, - 0.09-0.15; p-interaction = 0.01). The different behavior of cancer distress during time according to gender was more evident in subjects aged 68 or older due to increasing physical problems in men (p-interaction = 0.005). There was no change in fatigue with time according to sex. CONCLUSIONS: Women, younger age, and breast cancer patients had increased cancer distress at the initial visit. However, women tend to stabilize during follow-up, whereas men tend to worsen their distress, especially because of physical and emotional problems, suggesting different coping capabilities. TRIAL REGISTRATION: The study is registered at ClinicalTrials.gov NCT05122052. IMPLICATIONS FOR CANCER SURVIVORS: Interventions aimed at improving recognition of emotions related to disease experience in male cancer survivors appear necessary.

Association Between the Multidimensional Prognostic Index and Mortality During 15 Years of Follow-up in the InCHIANTI Study.

BACKGROUND: Multidimensional Prognostic Index (MPI) is recognized as a prognostic tool in hospitalized patients, but data on the value of MPI in community-dwelling older persons are limited. Using data from a representative cohort of community-dwelling persons, we tested the hypothesis that MPI explains mortality during 15 years of follow-up. METHODS: A standardized comprehensive geriatric assessment was used to calculate the MPI and to categorize participants in low-, moderate-, and high-risk classes. The results were reported as hazard ratios (HRs) and the accuracy was evaluated with the area under the curve (AUC), with 95% confidence intervals (CIs) and the C-index. We also reported the median survival time by standard age groups. RESULTS: All 1453 participants (mean age 68.9 years, women = 55.8%) enrolled in the InCHIANTI study at baseline were included. Compared to low-risk group, participants in moderate (HR = 2.10; 95% CI: 1.73-2.55) and high-risk MPI group (HR = 4.94; 95% CI: 3.91-6.24) had significantly higher mortality risk. The C-index of the model containing age, sex, and MPI was 82.1, indicating a very good accuracy of this model in explaining mortality. Additionally, the time-dependent AUC indicated that the accuracy of the model incorporating MPI to age and sex was excellent (>85.0) during the whole follow-up period. Compared to participants in the low-risk MPI group across different age groups, those in moderate- and high-risk groups survived 2.9-7.0 years less and 4.3-8.9 years less, respectively. CONCLUSIONS: In community-dwelling individuals, higher MPI values are associated with higher risk of all-cause mortality with a dose-response effect.

A Three-Domain Scoring System to Customize the Risk of Relapse of Differentiated Thyroid Carcinoma.

PURPOSE: the validation of a new scoring model considering the principal risk factors of differentiated thyroid cancer (DTC) relapse. METHODS: we evaluated all DTC patients treated with thyroidectomy and radioactive iodine (RAI) therapy. Three domains were considered: the demographic domain (age and gender), the surgical domain (histology and the American Thyroid Association risk categories), and the RAI-related domain (pre-RAI thyroglobulin and post-therapeutic 131I whole-body scan). The progression-free survival was assessed. The patients' sample was randomly split into a training and validation set. The three-domain score was calculated as the weighted sum of the levels of each significant factor, then scaled to an integer range (0-100) and, finally, stratified into terciles: mild risk 0-33, moderate risk 34-66, and severe risk 67-100. RESULTS: 907 DTC patients were included. The RAI-related domain was the most relevant factor in the score calculation. The tercile stratification identified significantly different survival curves: patients within the two upper terciles showed approximately 6 to 30 times more progressive risk than patients at mild risk. CONCLUSION: we have validated a three-domain scoring system and the principal impact on this score is provided by the peri-RAI findings, whose prognostic role seems to be essential in risk identification.

Multidimensional Frailty Predicts Mortality Better than Physical Frailty in Community-Dwelling Older People: A Five-Year Longitudinal Cohort Study.

Frailty is a common syndrome in older people that carries an increased risk of mortality. Two main models describe frailty, either as a loss of physical functions or as an accumulation of multiple deficits. The aim of our study was to compare the physical frailty index developed in the Cardiovascular Health Study (CHS) with a multidimensional frailty tool, the Multidimensional Prognostic Index (MPI), in predicting death in community-dwelling older subjects. Four hundred and seven community-dwelling older subjects were enrolled. Each subject underwent a comprehensive geriatric assessment (CGA) with calculation of the MPI and CHS index. Mortality was recorded over the following 5 years. In the overall sample (mean age of 77.9 ± 4.5 years; 51.6% female), 53 subjects (13%) died during the 5-year follow-up period. Both the MPI and CHS index were able to predict mortality; however, the MPI was significantly more accurate than the CHS index in predicting mortality (C-index = 0.69 and 0.59, respectively; p < 0.001), with a statistically significant difference of 10%. In conclusion, multidimensional frailty, assessed by the MPI, predicts five-year mortality in community-dwelling older people better than physical frailty, as assessed by the CHS index. These findings suggest the usefulness of assessing frailty by means of CGA-based tools to predict relevant health-negative outcomes in older people.