Patient safety is the moral and ethical responsibility of healthcare professionals, representing a constantly evolving field in industrialized countries whose key factors are sustainability, training and prevention. Clinical risk management is primarily concerned with systems issues, but people are of paramount importance to effective teamwork and leadership. Hospitals have recently been urged to adopt the methods of high-fidelity organizations to identify and change ineffective practice patterns: recognizing that little things that go wrong are early warning signs of trouble, near miss and errors become information about the health of systems and learn from them. Italian Cardiology will have to assume clinical risk as a common practice, through a rigorous examination of the causes of adverse events, staff training, sharing of validated adverse event analysis tools, identification of corrective actions and definition of shared procedures, the systematic control of the adoption of the planned interventions, the evaluation of the results of the measures implemented by applying stringency and scientific method in this area. The text tries to explain, in a pragmatic way, the main problems that hinder the diffusion of the culture of safety in Italian hospitals and in cardiology by proposing solutions.

Introduction. Endocrine disorders and impaired gonadal function are the most frequent sequelae after transplantation. Methods. Male patients <18 years transplanted in the period 1992-2021 in the Pediatric Transplant Unit in Monza, surviving more than 2 years after HSCT, who either experienced spontaneous puberty (Tanner stage ≥2, testicular volume (TV) ≥4 mL or serum testosterone ≥0.2 ng/mL) or received pharmacological pubertal induction were included in this study. Longitudinal endocrine evaluations were performed every 6-12-months, including Tanner stage and TV assessment and LH, FSH, total testosterone, among laboratory data. Results. Of 130 patients (median age 9 years at HSCT, 21 years at last follow-up) fulfilling inclusion criteria, 65% were transplanted for acute leukemia, 9% for other malignancies and 26% for non malignant diseases after a TBI (45%), busulfan (27%), 14% treosulfan-based or 15% a different chemo-only conditioning. Upon HSCT 56% were prepubertal (PreP) and 44% where either peri- or postpubertal (PostP). The pubertal status upon the last endocrine evaluation was consistent with Tanner stage 3, 4 and 5 in 15%, 23% and 62% of the patients, respectively. Overall, 44% had spontaneously progressed into puberty and had a normal gonadal profile (NOR) and 56% had experienced either pubertal arrest (1%), isolated increase of FSH (IIF 19%), compensated hypergonadotropic hypogonadism (cHH, 23%) or overt hypergonadotropic hypogonadism (oHH, 13%). Gonadal outcome was not affected by pubertal status upon HSCT (p 0.298), even though, out of 81 patients who had achieved Tanner stage 5, TV was statistically greater in the PostP (12.2±5.1 ml) than in the PreP cohort (10.3±4.1 ml, p 0.049), whereas there were no significant differences in the last testosterone level recorded in the two cohorts, as well as in the hypogonadal versus the event-free patients (p 0.53), with events defined as any gonadal issue (IIF, cHH, oHH). TV was significantly lower in patients who developed any endocrine disfunction versus those who didn't. LH and testosterone levels showed a specular trend between 20 and 30 years, when a progressive decrease in sexual steroids was associated with a compensatory increase of the luteinizing hormone. Overall, adult LH (p 0.728) as well as FSH levels (p 0.318) were superimposable in the PreP and PostP cohorts. In terms of the impact of the conditioning regimen on gonadal outcomes, a certain degree of gonadal dysfunction (ranging from isolated increase of FSH to hypogonadism or pubertal arrest) was recorded in 37% of the patients overall, and in 85% of the patients after TBI, 51% after busulfan and 32% after cyclophoshamide/fludarabine, whereas no abnormal findings were found among the 18 patients exposed to treosulfan. The likelihood of a gonadal event-free course was lowest for the TBI and busulfan cohorts, both overall (p<0.0001) and for PreP patients (p<0.0001), whereas it was 100% among the 18 patients conditioned with treosulfan-based schedules. A remarkably greater gonadotoxicity was detected in the busulfan compared with the treosulfan cohort (p 0.024), with a similar trend in the PreP and PostP subcohorts. Busulfan/cyclophosphamide-based conditioning regimens were associated with statistically larger median TV (p <0.001), higher testosterone levels (p 0.008) and lower LH/FSH levels (p <0.001) than those exposed to TBI. Conditioning regimen (p 0.047) and pubertal status upon HSCT (p <0.0001) were the only variables significantly associated with testicular outcomes in the Cox model, with exposure to TBI being associated with a 2-fold increase in the risk of gonadal failure compared to busulfan (OR 1.93, CI 1.08-3.70), whereas being pre-pubertal upon HSCT was protective, as it was associated with a halved risk of developing any degree of testicular damage (OR 0.50, CI 0.26-0.70). Conclusions. We demonstrated a i. halved risk of developing post-HSCT hypogonadism in prepubertal patients at HSCT, despite overall smaller final testicular volume; ii. downwards trend in testosterone levels after the achievement of full spontaneous puberty compensated by an inverse upwards trend in LH levels; iii gonadal-sparing profile of treosulfan compared to busulfan-based regimens, with a statistically lower occurrence of hypogonadism and a trend towards larger testicular volume, higher testosterone levels and lower gonadotropins.

To investigate current ED management of patients with syncope in Italy and opportunities for optimization, we carried out a questionnaire survey involving 102 directors of ED facilities in our country, of any complexity level, with 55.9% located in the North, 97% equipped with an ED Observation Unit (EDOU), and 21.8% with an outpatient Syncope Unit (SU). 43.6% of EDs management is not standardized. Clinical judgment and monitoring are the main factors leading management while old age and neuropsychic comorbidities the most hindering it. More than one third of ED facilities treats fewer than half of patients in EDOU. Most of respondents (73.7%) reported an admission rate within 20%, primarily in cardiology, in the case of an established or suspected cardiac etiology of syncope. In most centers, the referral to the general practitioner is the priority path at discharge from ED. Nearly 50% of participants rated syncope management in their own center as sub-optimal. To optimize it, 98% of them believe that is appropriate to implement a standardized approach, with and a large majority focusing on increasing diagnostic yield and safety; other priorities include application of guidelines, implementation of care pathways, enhancement of the role of EDOU, and direct path to the SU. This study highlights that the management of syncope patients in our country requires a further improvement, especially through standardization of pathways and adoption of innovative organizational solutions. Admissions appear to be lower than reported in the literature but this finding must be confirmed by a multicentric study based on direct collection of data.

BackgroundPain constitutes a serious problem of a health, economic, ethical, and social equity nature affecting negatively quality of life. Its assessment is often subjected to overestimation or underestimation. AimThe aim of this study is threefold: (1) to estimate the prevalence of pain in hospitalized patients; (2) to assess the grade of correlation between the level of pain observed by the nurses and the pain perceived by the patients; and (3) to examine the level of scientific knowledge among the healthcare professionals. DesignCross-sectional study. MethodsThe intensity level of observed and perceived pain has been evaluated in 401 patients with validated scales. Analyzed data have been extracted from the electronic medical record and integrated into the data-collection sheet. A questionnaire has been submitted to nurses to investigate their level of knowledge on pain assessment and management. ResultsThe study included 350 patients out of 401; for 51 patients the “pain” data was missing. Prevalence of perceived pain was 40.15%. Nurses overestimated pain in 7.43% of cases and underestimated it in 24.9%. The majority of the nursing staff claimed to be aware of the pain topic, however, they showed some uncertainties in clinical practice. ConclusionsThe differential variation between the observed pain and the perceived one resulted in 43.71% of cases, highlighting the dependence on the two variables: “area of hospitalization” and “intensity level”. The observation and monitoring of pain did not appear to be a consolidated practice, thus representing an important area for investments in the nursing profession.

AimsInvestigate if different clinical and psychophysical bedside tools can differentiate between district migraine phenotypes in ictal/perictal (cohort 1) and interictal (cohort 2) phases.MethodThis observational study included two independent samples in which patients were subgrouped into distinct clusters using standardized bedside assessment tools (headache frequency, disability, cervical active range of motion, pressure pain threshold in different areas): (A) cohort 1—ictal/perictal migraine patients were subgrouped, based on previous studies, into two clusters, i.e., Cluster-1.1 No Psychophysical Impairments (NPI) and Cluster-1.2 Increased Pain Sensitivity and Cervical Musculoskeletal Dysfunction (IPS-CMD); (B) cohort 2—interictal migraine patients were subgrouped into three clusters, i.e., Cluster-2.1 NPI, Cluster-2.2 IPS, and Cluster-2.3 IPS-CMD. Clinical characteristics (multiple questionnaires), somatosensory function (comprehensive quantitative sensory testing (QST)), and cervical musculoskeletal impairments (cervical musculoskeletal assessment) were assessed and compared across headache clusters and a group of 56 healthy controls matched for sex and age.ResultsCohort 1: A total of 156 subjects were included. Cluster-1.2 (IPS-CMD) had higher headache intensity (p = 0.048), worse headache-related (p = 0.003) and neck-related disability (p = 0.005), worse quality of life (p = 0.003), and higher symptoms related to sensitization (p = 0.001) and psychological burden (p = 0.005) vs. Cluster-1.1(NPI). Furthermore, Cluster-1.2 (IPS-CMD) had (1) reduced cervical active and passive range of motion (p < 0.023), reduced functionality of deep cervical flexors (p < 0.001), and reduced values in all QST(p < 0.001) vs. controls, and (2) reduced active mobility in flexion, left/right lateral flexion (p < 0.045), and reduced values in QST (p < 0.001) vs. Cluster-1.1 (NPI). Cohort 2: A total of 154 subjects were included. Cluster-2.3 (IPS-CMD) had (1) longer disease duration (p = 0.006), higher headache frequency (p = 0.006), disability (p < 0.001), and psychological burden (p = 0.027) vs. Cluster-2.2 (IPS) and (2) higher headache-related disability (p = 0.010), neck-related disability (p = 0.009), and higher symptoms of sensitization (p = 0.018) vs. Cluster-2.1 (NPI). Cluster-2.3(IPS-CMD) had reduced cervical active and passive range of motion (p < 0.034), and reduced functionality of deep cervical flexors (p < 0.001), vs. controls, Custer-2.1 (NPI), and Cluster-2.2 (IPS). Cluster-2.2 (IPS) and 2.3 (IPS-CMD) had reduced QST values vs. controls (p < 0.001) and Cluster-2.1 (p < 0.039).ConclusionA battery of patient-related outcome measures (PROMs) and quantitative bedside tools can separate migraine clusters with different clinical characteristics, somatosensory functions, and cervical musculoskeletal impairments. This confirms the existence of distinct migraine phenotypes and emphasizes the importance of migraine phases of which the characteristics are assessed. This may have implications for responders and non-responders to anti-migraine medications.

Pembrolizumab has received approval as a first-line treatment for unresectable/metastatic triple-negative breast cancer (mTNBC) with a PD-L1 combined positive score (CPS) of ≥ 10. However, assessing CPS in mTNBC poses challenges. Firstly, it represents a novel analysis for breast pathologists. Secondly, the heterogeneity of PD-L1 expression in mTNBC further complicates the assessment. Lastly, the lack of standardized assays and staining platforms adds to the complexity. In KEYNOTE trials, PD-L1 expression was evaluated using the IHC 22C3 pharmDx kit as a companion diagnostic test. However, both the 22C3 pharmDx and VENTANA PD-L1 (SP263) assays are validated for CPS assessment. Consequently, assay-platform choice, staining conditions, and scoring methods can significantly impact the testing outcomes. This consensus paper aims to discuss the intricacies of PD-L1 CPS testing in mTNBC and provide practical recommendations for pathologists. Additionally, we present findings from a nationwide Italian survey elucidating the state-of-the-art in PD-L1 CPS testing in mTNBC.

(1) Influenza causes a significant health and socio-economic burden every year, and health personnel (HP) are at higher risk of exposure to respiratory pathogens than the general population. (2) The study's purpose was to describe and compare influenza vaccine uptake and its prognostic factors among Medical Doctors (MDs) and Non-Medical Health Personnel (NMHP) vs. Non-HP (NHP). We analyzed 2014-2018 data (n = 105,608) from the Italian Behavioral Risk Factor Surveillance System PASSI that, since 2008, has been collecting health-related information continuously in sampled adults. (3) MDs and NMHP represented, respectively, 1.1% and 4.6% of the sample. Among HP, 22.8% (CI 19.8-26.1%) of MDs and 8.5% (CI 7.5-9.5%) of NMHP reported to have been vaccinated vs. 6.3% (CI 6.1-6.5%) in NHP. This difference is confirmed in the three categories (MDs, NMHP, NHP), even more across age groups: in 18-34 yy, respectively, 9.9%, 4.4%, 3.4% vs. 28.4%, 13.9%, 10.6% in 50-64 yy. PASSI surveillance shows an increasing influenza vaccination uptake over time, especially among MDs (22.2% in 2014 vs. 30.5% in 2018). (4) Despite such an increase, especially among younger HP, influenza vaccination uptake is low. Even more under pandemic scenarios, these figures represent key information to address effective strategies for disease prevention and health promotion.

Abstract Background Thrombocytopenia represents an important issue in patients undergoing Transcatheter aortic valve replacement (TAVR) due to severe aortic stenosis. We performed a systematic review and meta–analysis to establish the pooled prevalence and the in–hospital outcomes of Chronic thrombocytopenia (cTCP) in patients after TAVR. Methods PubMed and Scopus databases were systematically searched for articles, published in any language, from inception through September 15, 2022, reporting the prevalence of cTCP in patients who underwent TAVR and providing data on the hospital outcomes. The pooled prevalence and the outcomes were evaluated pooling the adjusted odds ratio (OR) with the related 95% confidence interval (CI) using a random– effect models. Statistical heterogeneity between groups was measured using the Higgins I2 statistic Results Overall, 1,402,431 patients (mean age 87.2 years, 45.1% females) where hospitalized for TAVR. Among them, cTCP was observed in 7.0% of cases (95% CI: 1.7–24.5%, p&amp;lt;0.0001, I2:84.5%). No significant differences were observed for in–hospital mortality and stroke comparing patients with cTCP to those without (OR: 1.07, 95% CI: 0.62–1.82, p=0.802, I2: 79.6% and OR: 0.90, 95% CI: 0.67–1.21, p=0.48, I2: 0%, respectively). Conversely, cTCP subjects showed a significant higher risk of vascular complications (OR: 1.72, 95% ci 1.37–2.16, p&amp;lt;0.0001, I2:0%), acute kidney injury (OR: 1.60, 95% CI: 1.16–2.20, p=0.004, I2:81.4%) and cardiac tamponade (OR: 3.31, 95% ci: 1.85–5.94, p&amp;lt;0.0001, I2: 0%) (Figure 1). Conclusions cTCP is present in about 7% of patients underoing TAVR and was results associated with an increased risk of vascular complications and cardiac tamponade during the periprocedural period.

A novel ablation catheter has been released to map and ablate the cavo-tricuspid isthmus (CTI) in patients with atrial flutter (AFL), improving ablation efficiency. We evaluated the acute and long-term outcome of CTI ablation aiming at bidirectional conduction block (BDB) in a prospective, multicenter cohort study enrolling 500 patients indicated for typical AFL ablation. Patients were grouped on the basis of the AFL ablation method (linear anatomical approach, Conv group n = 425, or maximum voltage guided, MVG group, n = 75) and ablation catheter (mini-electrodes technology, MiFi group, n = 254, or a standard 8-mm ablation catheter, BLZ group, n = 246). Complete BDB according to both validation criteria (sequential detailed activation mapping or mapping only the ablation site) was achieved in 443 patients (88.6%). The number of RF applications needed to achieve BDB was lower in the MiFi MVG group vs both the MiFi Conv group and the BLZ Conv group (3.2 ± 2 vs 5.2 ± 4 vs 9.3 ± 5, p < 0.0001 for all comparisons). Fluoroscopy time was similar among groups, whereas we observed a reduction in the procedure duration from the BLZ Conv group (61.9 ± 26min) to the MiFi MVG group (50.6 ± 17min, p = 0.048). During a mean follow-up of 548 ± 304 days, 32 (6.2%) patients suffered an AFL recurrence. No differences were found according to BDB achieved by both validation criteria. Ablation was highly effective in achieving acute CTI BDB and long-term arrhythmia freedom irrespective of the ablation strategy or the validation criteria for CTI chosen by the operator. The use of an ablation catheter equipped with mini-electrodes technology seems to improve ablation efficiency. Atrial Flutter Ablation in a Real World Population. (LEONARDO). gov Identifier: NCT02591875.

Currently, all patients, regardless of the type of head injury, should undergo a head computerized tomography (CT) if on oral anticoagulant therapy. The aim of the study was to assess the different incidences of intracranial hemorrhage (ICH) between patients with minor head injury (mHI) and patients with mild traumatic brain injury (MTBI) and whether there were differences in the risk of death at 30days as a result of trauma or neurosurgery. A retrospective multicenter observational study was conducted from January 1, 2016, to February 1, 2020. All patients on DOACs therapy who suffered head trauma and underwent a head CT were extracted from the computerized databases. Patients were divided into two groups MTBI vs mHI all in DOACs treatment. Whether a difference in the incidence of post-traumatic ICH was present was investigated, and pre- and post-traumatic risk factors were compared between the two groups to assess the possible association with ICH risk by propensity score matching. 1425 with an MTBI in DOACs were enrolled. Of these, 80.1% (1141/1425) had an mHI and 19.9% (284/1425) had an MTBI. Of these, 16.5% (47/284) patients with MTBI and 3.3% (38/1141) with mHI reported post-traumatic ICH. After propensity score matching, ICH was consistently found to be more associated with patients with MTBI than with mHI (12.5% vs 5.4%, p = 0.027). Risk factors associated with immediate ICH in mHI patients were high energy impact, previous neurosurgery, trauma above the clavicles, post-traumatic vomiting and headache. Patients on MTBI (5.4%) were found to be more associated with ICH than those with mHI (0.0%, p = 0.002). also when the need for neurosurgery or death within 30days were considered. Patients on DOACs with mHI have a lower risk of presenting with post-traumatic ICH than patients with MTBI. Furthermore, patients with mHI have a lower risk of death or neurosurgery than patients with MTBI, despite the presence of ICH.