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Sabrina Castellano,1 Carla Torrent,2 Maria Cristina Petralia,3 Justyna Godos,4 Rita Anna Cantarella,5 Andrea Ventimiglia,6 Simona De Vivo,6 Silvia Platania,1 Maria Guarnera,7 Concetta Pirrone,1 Filippo Drago,4 Eduard Vieta,2 Santo Di Nuovo,1 Dina Popovic,2,8,* Filippo Caraci4,9,* 1Department of Educational Sciences, University of Catania, Catania, Italy; 2Barcelona Bipolar Disorders Program, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Catalonia, Spain; 3IRCCS Centro Neurolesi Bonino Pulejo, Messina, Italy; 4Oasi Research Institute-IRCCS, Troina 94018, Italy; 5Department of Mental Health, ASP3 Catania, Catania, Italy; 6Villa dei Gerani Clinic ASP3 Catania, Catania, Italy; 7Faculty of Human and Social Sciences, University of Enna “KORE”, Enna, Italy; 8Bipolar Disorders Program, Sheba Medical Center, Ramat Gan, Israel; 9Department of Drug Sciences, University of Catania, Catania, Italy*These authors contributed equally to this workCorrespondence: Sabrina CastellanoDepartment of Educational Sciences, University of Catania, Via Ofelia 1, Catania 95124, ItalyTel +39 0952508060Fax +39 0952508070Email sabrina.castellano@unict.itBackground: Cognitive dysfunction represents a distinct biological and clinical dimension in major depression disorders (MDD) and cognitive performance strongly affects psychosocial functioning in patients diagnosed with MDD.Objective: To assess which neurocognitive variables at baseline predict the functional outcome of MDD patients in a 1-year follow-up study as assessed by Functioning Assessment Short Test (FAST) and whether the improvement observed on affective and cognitive symptoms in our 12 week-prospective observational study after treatment with selective serotonin reuptake inhibitors (SSRIs) and selective noradrenalin reuptake inhibitors (SNRIs) can affect the following long-term psychosocial functional outcome at 1 year in the same MDD patients.Methods: We recruited a total of 31 patients (8 males; 23 females) with MDD who had previously completed a pharmacological treatment with SSRIs (n = 22) or SNRIs (n = 9) for 12 weeks, and then continued the same pharmacological treatment for 1 year. After an average 1-year follow-up, they were interviewed with the FAST to assess functional outcome. Multivariate analyses were applied to identify clinical and neurocognitive predictors of functional outcome.Results: Total Montreal Cognitive Assessment (MoCA), Digit Span forward (Span F) and backward (Span B), and 15 Rey words immediate recall (Rey I) scores significantly correlated with FAST. However, after performing regression models only Rey immediate recall score was useful to predict long-term functional outcome (Pearson correlation coefficient R= − 0.68, p

OBJECTIVE: Dabigatran is a novel target specific oral anticoagulant for stroke prevention in non valvular atrial fibrillation. Little is still known about its real-world effectiveness and safety in the italian population. Aim of our study was to evaluate the efficacy and safety of dabigatran in a large single-center cohort of "real- life" italian population with non-valvular AF and to compare the results with those obtained from the RE-LY trial and the Medicare study. PATIENTS AND METHODS: We studied a prospective cohor t of 2108 patients (1119 male; mean age 69.4 ± 9.4 years) who started the oral anticoagulant treatment with dabigatran 110 mg twice-daily (DAB 110; N = 1075; 51%) or 150 mg twice-daily (DAB 150; N = 1033; 49%). Follow-up data were obtained trough outpatients visits each 3-6 months for assessing the clinical status, adherence to treatment, occurrence of side effects and major cardiovascular complications. RESULTS: In DAB 150 group the mean age was 64.9 ± 8.8 years, 56.8% of patients was male. CHA2DS2Vasc Score was ≥3 in 94.3% and HASBLED was ≥3 in 59.7%. In DAB 110 group (N = 1075) the mean age was 73.9 ± 7.5 years; 49.5% of patients was male. CHA2DS2Vasc Score was ≥ 3 in 73.4% and HAS-BLED was ≥3 in 87.4% of DAB 110 patients. One patient taking Dabigatran 110 mg bid had ischemic stroke without significantly neurological sequelae. In both groups, no patient experienced hemorrhagic stroke during the follow-up period. 147 patients (6.9%) of MonaldiCare population reported adverse effects from treatment with dabigatran, of whom 121 patients (5.7%) discontinued therapy. We reported one case of subarachnoid hemorrhage (0.05%) in a patient with high thrombo-embolic and high hemorrhagic risk score who was taking dabigatran 150 mg bid and one case (0.05%) of bladder bleeding in a patient who was taking dabigatran 110 mg bid. No major gastrointestinal bleeding was observed in the MonaldiCare population. CONCLUSIONS: MonaldiCare registry showed a safety profile of both dosages of dabigatran regarding major of fatal bleeding in a "real life" single center italian population at high thromboembolic and hemorrhagic risk. The majority of MonaldiCare patients tolerated dabigatran treatment without significant side effects. The efficacy of dabigatran was demonstrated by very low prevalence of ictus/TIA, also when patients underwent electrical AF cardioversion independently of the transesophageal examination. [ABSTRACT FROM AUTHOR]

Purpose: The Manta Vascular Closure Device is a novel collagen-based vascular closure device that has been designed specifically for closure of large-bore percutaneous arterial accesses. The aim of this retrospective study is to evaluate the immediate and 30-day outcome of Manta at the completion of endovascular aneurysm repair (EVAR) or thoracic endovascular aortic repair (TEVAR). The hypothesis is that Manta is not inferior in obtaining hemostasis compared with the Perclose ProGlide Suture-Mediated Closure System device., Materials and Methods: We recruited all the percutaneous accesses for (T)EVAR performed from January 2021 to April 2023 by all the Italian Divisions of Vascular Surgery using Manta at the time of data collection (May 2023). The primary outcome is to evaluate the incidence of complications at the puncture site after Manta implantation and at 1 month, and compare this with ProGlide. We applied the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) criteria for observational studies., Results: Overall, 524 consecutive femoral accesses for (T)EVAR procedures were collected: 355 in the Manta cohort and 169 in the ProGlide cohort, respectively. The size of the sheath was 17.2±2.7 Fr for Manta, 15.7±2.3 Fr for ProGlide (p<0.001). No statistically significant differences between the groups regarding age, sex, body mass index, ultrasound-guided access, femoral calcifications, intraoperative, and 30-day complications. Successful arterial closure at groin puncture sites for (T)EVAR using Manta is 90.5% and 93.1% using ProGlide. Freedom for any reintervention for any complication is 95.5% for Manta and 96% for ProGlide., Conclusion: The 2 vascular closure devices have proved to be similar in terms of complications, without any statistically significant difference, although the median size of the sheaths for (T)EVAR was statistically significantly larger when Manta has been used, compared with ProGlide., Clinical Impact: Manta® is effective in the hemostasis of the access sites following the completion of (T)EVAR in this multicenter, retrospective, case-control study on 524 percutaneous femoral accesses. Compared to the more popular Proglide®, the average size of the introducers in the Manta® group was significantly larger than in the Proglide® group., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Snapping hip syndrome (SHS) is characterized by snapping sensation and pain and affects up to 10% of the general population. External snapping hip syndrome (ESHS), the most common form, is often due to repetitive movements in sports or anatomical predispositions. Conservative treatment includes physiotherapy and corticosteroid injections, while surgery is considered if conservative measures fail. Open surgical techniques carry several risks, while modern arthroscopic techniques offer less invasive options, such as endoscopic iliotibial band release (ITB) and gluteus maximus tenotomy., Materials and Methods: A systematic review was conducted adhering to the PRISMA guidelines. Relevant studies were searched in four databases: Pubmed, Scopus, Embase, and Medline. The selected articles were evaluated according to the criteria of levels of evidence. The Risk of Bias In Non-randomized Studies of Interventions (ROBINS-I) was used to analyze the retrospective studies. This paper was registered in the International Prospective Registry of Systematic Reviews (PROSPERO)., Results: Out of 9 included studies, 403 patients with 689 hips underwent endoscopic treatment. ITB release and his variations were the main surgical techniques. Gluteus maximus tenotomy was also used in some studies. Postoperative rehabilitation protocols varied. Patients generally experienced significant improvements in symptoms and functional outcomes, with low rates of recurrence (1.02%) and revision (0.15%). Complications were minimal., Conclusions: Endoscopic treatment of ESH shows favorable results, improving functional outcomes and returning patients to pre-injury activity levels. Long-term efficacy and costeffectiveness need to be evaluated, emphasizing the importance of large-scale prospective randomized trials to clarify surgery's benefits in refractory ESH cases., (© 2024. The Author(s).)

Background: Hip replacement surgery is highly effective in relieving pain and improving mobility in patients with various hip conditions. However, some patients develop groin pain after surgery, often due to iliopsoas impingement (IPI), which can be challenging to diagnose. Conservative treatments are initially recommended, but when these are not effective, surgical options may be considered. This study aims to evaluate the clinical outcomes, success and failure rates, revision rates, and complications associated with arthroscopic and endoscopic surgery for IPI, thereby providing a comprehensive understanding of the effectiveness and risks of these surgical interventions., Materials and Methods: A systematic review was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, including a thorough search of five main databases: PubMed, Scopus, Embase, Medline, and Cochrane. Eligible articles were meticulously evaluated according to predefined criteria for levels of evidence (LoE), with retrospective studies assessed using the Coleman Methodology Score (mCMS). This systematic review was registered in the International Prospective Registry of Systematic Reviews (PROSPERO)., Results: Among the 16 included studies, 431 patients with 434 hips underwent either endoscopic or arthroscopic tenotomy. Both techniques showed favorable outcomes, with arthroscopic tenotomy demonstrating slightly higher success rates than endoscopic tenotomy. Common complications included mild pain and occasional infections, with recurrence observed in some cases. Both techniques offer direct visualization of prosthetic components and potential preservation of psoas function., Conclusions: Arthroscopic and endoscopic iliopsoas tenotomy are effective treatments for alleviating symptoms and improving hip function in patients with IPI post-total hip arthroplasty (THA)., Level of Evidence: IV., (© 2024. The Author(s).)

Background: Real-world evidence is needed to determine the value of tofacitinib (TOFA) for the treatment of ulcerative colitis (UC)., Aim: To assess the safety and effectiveness of TOFA in clinical practice., Methods: TOFA-UC is a multicenter, observational study performed among the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). All consecutive patients with UC starting TOFA from its introduction in Sicily (July 2021) to July 2022 were included., Results: 111 patients were included (mean follow-up: 31.7 ± 14.9 weeks; biologic-experienced: 92.8%). Nineteen adverse events were reported (17.1%; incidence rate: 28.2 per 100 patient years), including 11 cases of hypercholesterolemia and 3 infections (no cases of herpes zoster reactivation. At week 8, the rates of clinical response, steroid free clinical remission, and CRP normalization were 74.8%, 45.0%, and 56.9%, respectively, and 68.5%, 51.4%, and 65.2%, respectively, at the end of follow-up. Eighteen patients experienced a loss of response after successful induction (21.7%; incidence rate: 33.2 per 100 patient years). Twenty-six patients (23.4%) discontinued TOFA over time, of whom 3 due to AEs, and 23 to non response or loss of response., Conclusions: TOFA is safe and effective in patients with UC, including those with history of multiple failures to biological therapies., Competing Interests: Conflict of interest Fabio Salvatore Macaluso served as an advisory board member and/or received lecture grants from Biogen, Ferring, Galapagos, Janssen, MSD, Pfizer, Samsung Bioepis, and Takeda Pharmaceuticals. Walter Fries served as an advisory board member and/or received lecture grants from Abbvie, MSD, Takeda, Pfizer, Biogen, Sandoz, Zambon, Ferring Italia, Sofar. Anna Viola received lecture grants from Pfizer. Maria Cappello served as an advisory board member for AbbVie, MSD, Takeda Pharmaceuticals, and received lecture grants from AbbVie, MSD, Chiesi, and Takeda Pharmaceuticals. Filippo Mocciaro served as an advisory board member for Janssen and Galapagos, and received lecture grants from Takeda Pharmaceuticals. Antonino Carlo Privitera served as consultant to Mundipharma, Abbvie, MSD, Takeda, and Janssen, and received lecture fees from Abbvie, Sara Renna served as an advisory board member for AbbVie, Janssen, and MSD Pharmaceuticals, and received lecture grants from AbbVie, Janssen, MSD, Pfizer, and Takeda Pharmaceuticals. Ambrogio Orlando served as an advisory board member for AbbVie, Galapagos, MSD, Janssen, Pfizer, Samsung Bioepis, and Takeda Pharmaceuticals, and received lecture grants from AbbVie, Fresenius Kabi, Galapagos, MSD, Sofar, Chiesi, Janssen, Pfizer, and Takeda Pharmaceuticals., (Copyright © 2023 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Different studies have been conducted to understand how patients with unipolar and bipolar depression differ in terms of cognitive and affective symptoms as well as in psychosocial function. Furthermore, the impact of antidepressants, second-generation antipsychotics, and mood stabilizers on these dimensions needs to be characterized, as well as the best psychometric approach to measure changes after pharmacological treatment., Objectives: This study aims to analyze the impact of psychotropic drugs on cognitive, affective, and psychosocial functioning in MDD and BD patients; to test the sensitivity of psychometric tools for measuring those changes; also, to understand how psychosocial abilities are associated with affective and cognitive dimensions in patients with MDD and BD., Methods: A total of 22 patients with MDD and 21 patients with BD in the depressive phase were recruited. Several psychometric tests were administered to assess affective, cognitive, and psychosocial symptoms before and after 12 weeks of drug treatment (T0 and T1) with different psychotropic drugs including second-generation antidepressants, second-generation antipsychotics and mood stabilizers (lamotrigine)., Results: MDD patients showed significant improvement in MoCA, Delayed Recall of Rey's 15 Words and HDRS, while a significant worsening was detected on Digit Span Backwards and on FAST scores. Instead, patients with BD showed significant improvements in the MoCA as the MDD patients, but only a trend of improvement (non-statistically significant) on the BDI-II. A positive correlation was detected in both groups between FAST and HDRS and BDI-II scores, especially in BD patients., Conclusion: Our results demonstrate that drug treatment with psychotropic drugs can improve cognitive and affective symptoms, but not all psychometric tools may be equally sensitive to detect those changes in MDD vs. BD patients. Moreover, we found that affective and cognitive dimensions can be considered as different psychopathological dimensions both in unipolar and bipolar depression., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

(1) Background: Leadless pacemakers (LPs) have been proposed as a reimplantation strategy in pacing-dependent patients undergoing cardiac implantable electronic device (CIED) extraction for infection. In this study, we analysed the risk of LP infection when this device is implanted before lead extraction. (2) Methods: This was a retrospective study including patients who underwent LP implantation between 2017 and 2022. Patients were divided in two groups according to whether LP was implanted following CIED extraction for infection (Group 1) or other indications (Group 2). The primary aim was to describe the risk of LP infection. (3) Results: We included in this study 49 patients with a median age of 81 [20-94] years, mostly males (36, 73%). In Group 1 patients, 17 cases (85%) showed systemic CIED infections, and 11 (55%) had positive lead cultures. Most Group 1 cases (n = 14, 70%) underwent one stage of LP implantation and CIED extraction. Mortality rate during follow-up was 20% (nine patients). Patients were followed up for a median of 927 [41-1925], days and no cases of definite or suspected LP infections were identified. (4) Conclusions: The risk of LP infection was extremely low. LP appears as a potential option for reimplantation in this setting and should be considered in pacing-dependent patients at a high risk of CIED infection recurrence.

Introduction: The Major Depressive Disorder (MDD) is a mental health disorder that affects millions of people worldwide. It is characterized by persistent feelings of sadness, hopelessness, and a loss of interest in activities that were once enjoyable. MDD is a major public health concern and is the leading cause of disability, morbidity, institutionalization, and excess mortality, conferring high suicide risk. Pharmacological treatment with Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Noradrenaline Reuptake Inhibitors (SNRIs) is often the first choice for their efficacy and tolerability profile. However, a significant percentage of depressive individuals do not achieve remission even after an adequate trial of pharmacotherapy, a condition known as treatment-resistant depression (TRD)., Methods: To better understand the complexity of clinical phenotypes in MDD we propose Network Intervention Analysis (NIA) that can help health psychology in the detection of risky behaviors, in the primary and/or secondary prevention, as well as to monitor the treatment and verify its effectiveness. The paper aims to identify the interaction and changes in network nodes and connections of 14 continuous variables with nodes identified as "Treatment" in a cohort of MDD patients recruited for their recent history of partial response to antidepressant drugs. The study analyzed the network of MDD patients at baseline and after 12 weeks of drug treatment., Results: At baseline, the network showed separate dimensions for cognitive and psychosocial-affective symptoms, with cognitive symptoms strongly affecting psychosocial functioning. The MoCA tool was identified as a potential psychometric tool for evaluating cognitive deficits and monitoring treatment response. After drug treatment, the network showed less interconnection between nodes, indicating greater stability, with antidepressants taking a central role in driving the network. Affective symptoms improved at follow-up, with the highest predictability for HDRS and BDI-II nodes being connected to the Antidepressants node., Conclusion: NIA allows us to understand not only what symptoms enhance after pharmacological treatment, but especially the role it plays within the network and with which nodes it has stronger connections., (© 2023. The Author(s).)

Background and Aim: Postoperative recurrence (POR) following ileocolonic resection is a major concern in patients with Crohn's disease (CD). The role of ustekinumab (UST) in this setting is poorly known., Methods: All consecutive CD patients with a baseline colonoscopy at 6-12 months from ileocolonic resection showing POR (Rutgeerts score ≥ i2) who were treated with UST after the baseline colonoscopy and with an available post-treatment endoscopy, were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Diseases (SN-IBD). The primary outcome was endoscopic success, defined as reduction of at least one point of Rutgeerts score. The secondary outcome was clinical success, assessed at the end of follow-up. Reasons for clinical failure included mild clinical relapse (Harvey-Bradshaw index 5-7), clinically relevant relapse (Harvey-Bradshaw index > 7), and need for new resection., Results: Forty-four patients were included (mean follow-up: 17.8 ± 8.4 months). The baseline postoperative colonoscopy showed severe POR (Rutgeerts score i3 or i4) in 75.0% of patients. The post-treatment colonoscopy was performed after a mean of 14.5 ± 5.5 months following initiation of UST. Endoscopic success was reported in 22 out of 44 (50.0%) patients, of whom 12 (27.3%) achieved a Rutgeerts score i0 or i1. Clinical success at the end of follow-up was reported in 32 out of 44 patients (72.7%); none of the 12 patients with clinical failure had achieved endoscopic success at post-treatment colonoscopy., Conclusions: Ustekinumab could be a promising option for the treatment of POR of CD., (© 2023 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.)

(1) Background: Infections are among the most frequent and life-threatening complications of cardiovascular implantable electronic device (CIED) implantation. The aim of this study is to compare the outcome and safety of a single-procedure device extraction and contralateral implantation versus the standard-of-care (SoC) two-stage replacement for infected CIEDs. (2) Methods: We retrospectively included 66 patients with CIED infections who were treated at two Italian hospitals. Of the 66 patients enrolled in the study, 27 underwent a single procedure, whereas 39 received SoC treatment. All patients were followed up for 12 months after the procedure. (3) Results: Considering those lost to follow-up, there were no differences in the mortality rates between the two cohorts, with survival rates of 81.5% in the single-procedure group and 84.6% in the SoC group ( p = 0.075). (4) Conclusions: Single-procedure reimplantation associated with an active antibiofilm therapy may be a feasible and effective therapeutic option in CIED-dependent and frail patients. Further studies are warranted to define the best treatment regimen and strategies to select patients suitable for the single-procedure reimplantation.

The purpose of this study is to use a dynamic network approach as an innovative way to identify distinct patterns of interacting symptoms in patients with Major Depressive Disorder (MDD) and patients with Bipolar Type I Disorder (BD). More precisely, the hypothesis will be testing that the phenotype of patients is driven by disease specific connectivity and interdependencies among various domains of functioning even in the presence of underlying common mechanisms. In a prospective observational cohort study, hundred-forty-three patients were recruited at the Psychiatric Clinic "Villa dei Gerani" (Catania, Italy), 87 patients with MDD and 56 with BD with a depressive episode. Two nested sub-groups were treated for a twelve-week period, which allowed us to explore differences in the pattern of symptom distribution (central vs. peripheral) and their connectedness (strong vs weak) before (T0) and after (T1) treatment. All patients underwent a complete neuropsychological evaluation at baseline (T0) and at T1. A network structure was computed for MDD and BD patients at T0 and T1 from a covariance matrix of 17 items belonging to three domains-neurocognitive, psychosocial, and mood-related (affective) to identify what symptoms were driving the networks. Clinically relevant differences were observed between MDD and BD, at T0 and after 12 weeks of pharmacological treatment. At time T0, MDD patients displayed an affective domain strongly connected with the nodes of psychosocial functioning, while direct connectivity of the affective domain with the neurocognitive cluster was absent. The network of patients with BD, in contrast, revealed a cluster of highly interconnected psychosocial nodes but was guided by neurocognitive functions. The nodes related to the affective domain in MDD are less connected and placed in the periphery of the networks, whereas in BD they are more connected with psychosocial and neurocognitive nodes. Noteworthy is that, from T0 to T1 the "Betweenness" centrality measure was lower in both disorders which means that fewer "shortest paths" between nodes pass through the affective domain. Moreover, fewer edges were connected directly with the nodes in this domain. In MDD patients, pharmacological treatment primarily affected executive functions which seem to improve with treatment. In contrast, in patients with BD, treatment resulted in improvement of overall connectivity and centrality of the affective domain, which seems then to affect and direct the overall network. Though different network structures were observed for MDD and BD patients, data suggest that treatment should include tailored cognitive therapy, because improvement in this central domain appeared to be fundamental for better outcomes in other domains. In sum, the advantage of network analysis is that it helps to predict the trajectory of future phenotype related disease manifestations. In turn, this allows new insights in how to balance therapeutic interventions, involving different fields of function and combining pharmacological and non-pharmacological treatment modalities., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Platania et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Identifying sex-related differences/variables associated with 30 day/1 year mortality in patients with chronic limb-threatening ischemia (CLTI)., Methods: Multicenter/retrospective/observational study. A database was sent to all the Italian vascular surgeries to collect all the patients operated on for CLTI in 2019. Acute lower-limb ischemia and neuropathic-diabetic foot are not included., Follow-Up: One year. Data on demographics/comorbidities, treatments/outcomes, and 30 day/1 year mortality were investigated., Results: Information on 2399 cases (69.8% men) from 36/143 (25.2%) centers. Median (IQR) age: 73 (66-80) and 79 (71-85) years for men/women, respectively ( p < 0.0001). Women were more likely to be over 75 (63.2% vs. 40.1%, p = 0.0001). More men smokers (73.7% vs. 42.2%, p < 0.0001), are on hemodialysis (10.1% vs. 6.7%, p = 0.006), affected by diabetes (61.9% vs. 52.8%, p < 0.0001), dyslipidemia (69.3% vs. 61.3%, p < 0.0001), hypertension (91.8% vs. 88.5%, p = 0.011), coronaropathy (43.9% vs. 29.4%, p < 0.0001), bronchopneumopathy (37.1% vs. 25.6%, p < 0.0001), underwent more open/hybrid surgeries (37.9% vs. 28.8%, p < 0.0001), and minor amputations (22% vs. 13.7%, p < 0.0001). More women underwent endovascular revascularizations (61.6% vs. 55.2%, p = 0.004), major amputations (9.6% vs. 6.9%, p = 0.024), and obtained limb-salvage if with limited gangrene (50.8% vs. 44.9%, p = 0.017). Age > 75 (HR = 3.63, p = 0.003) is associated with 30 day mortality. Age > 75 (HR = 2.14, p < 0.0001), nephropathy (HR = 1.54, p < 0.0001), coronaropathy (HR = 1.26, p = 0.036), and infection/necrosis of the foot (dry, HR = 1.42, p = 0.040; wet, HR = 2.04, p < 0.0001) are associated with 1 year mortality. No sex-linked difference in mortality statistics., Conclusion: Women exhibit fewer comorbidities but are struck by CLTI when over 75, a factor associated with short- and mid-term mortality, explaining why mortality does not statistically differ between the sexes.

Background: Cardiac contractility modulation (CCM) is an innovative therapy for heart failure with reduced ejection fraction delivered by a cardiac implantable device (Optimizer Smart ® ). One of the most prominent periprocedural complications common to all cardiac implantable devices (CIDs) is tricuspid regurgitation (TR) due to the placement of the right ventricular endocardial leads. To date, no published studies have assessed the changes in the TR degree in patients with heart failure with reduced ejection fraction (HFrEF) who received an implantable cardioverter-defibrillator (ICD) after the implantation of cardiac contractility modulation therapy devices., Objective: This study aimed to evaluate the effect of the implantation of the trans-tricuspid leads required to deliver CCM therapy on the severity of TR in patients with HFrEF who previously underwent ICD implantation., Methods: We enrolled 30 HFrEF patients who underwent CCM therapy between November 2020 and October 2021. For all the patients, echocardiographic evaluations of TR were performed according to current guidelines 24 h before and six months after the Optimizer Smart ® implant was applied., Results: At the 6-month follow-up, the grade of TR remained unchanged compared to the preimplant grade. The value of the vena contracta (VC) of TR was 0.40 ± 0.19 cm in the preimplant period and 0.45 ± 0.21 cm at the 6-month follow-up ( p = 0.33). Similarly, the TR proximal isovelocity surface area (PISA) radius value was unchanged at follow-up (0.54 ± 0.22 cm vs. 0.62 ± 0.20 cm; p = 0.18). No statistically significant difference existed between the preimplant VC and PISA radius values, irrespective of the device type., Conclusions: The implantation of right ventricular electrodes for the delivery of CCM therapy did not worsen tricuspid regurgitation in patients with HFrEF and ICD.

(1) Background: Management of cardiac implantable electronic device-related infective endocarditis (CIED-IE) hinges on complete hardware removal. We assessed whether long-term prognosis is affected by device removal, considering baseline patient comorbid conditions; (2) Methods: A total of 125 consecutive patients hospitalized for CIED-IE were included in this retrospective analysis. Outcomes were in-hospital, one-year, and long-term mortality. There were 109 patients who underwent device removal, 91 by transvenous lead extraction (TLE) and 18 by open heart surgery (OHS); (3) Results: TLE translated into lower hospital mortality (4.4% vs. 22.5% with OHS; p = 0.03). Septic pulmonary embolism was the only independent predictor of in-hospital mortality (OR:7.38 [1.49-36.6], p = 0.013). One-year mortality was in contrast independently associated to tricuspid valve involvement ( p = 0.01) and Charlson comorbidity index (CCI, p = 0.039), but not the hardware removal modality. After a median follow-up of 41 months, mortality rose to 24%, and was significantly influenced only by CCI. Specifically, patients with a higher CCI who were also treated with TLE showed a survival rate not significantly different from those managed with medical therapy only; (4) Conclusions: In CIED-IE, TLE is the strategy of choice for hardware removal, improving early outcomes. Long-term benefits of TLE are lessened by comorbidities. In cases of CIED-IE with high CCI, a more conservative approach might be an option.

Background: Safety and efficacy of leadless pacemakers (L-PM) have been demonstrated in multiple clinical trials, but real-world data on patient selection, implantation technique, and peri-procedural patient management in a clinical practice setting are lacking., Methods: Consecutive patients undergoing L-PM implantation in 14 Italian centers were followed in a prospective, multicentre, observational project. Data on baseline patient characteristics, clinical indications, implantation procedure, and peri-procedural patient management were collected. The rate and nature of device-related complications were also recorded., Results: A total of 782 L-PM patients (68.4% male, 75.6 ± 12.4 years) were included in the analysis. The main patients-related reason leading to the choice of implanting a L-PM rather than a conventional PM was the high-risk of device infection (29.5% of cases). The implantation success rate was 99.2%. The median duration of the procedure was 46 min. In 90% of patients the device was implanted in the septum. Of patients on oral anticoagulant therapy (OAT) (n = 498) the implantation procedure was performed without interrupting (17.5%) or transiently interrupting OAT without heparin bridging (60.6%). During a median follow-up of 20 months major device-related complications occurred in 7 patients (0.9%): vascular access-site complications in 3 patients, device malfunction in 2 patients, pericardial effusion/cardiac tamponade in one patient, device migration in one patient., Conclusions: In the real world setting of Italian clinical practice L-PM is often reserved for patients at high-risk of infection. The implantation success rate was very high and the risk of major complications was low. Peri-procedural management of OAT was consistent with available scientific evidence., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: Virtually all patients with heart failure with reduced ejection fraction have a reduction of myocardial mechano-energetic efficiency (MEE). Cardiac contractility modulation (CCM) is a novel therapy for the treatment of patients with HFrEF, in whom it improves the quality of life and functional capacity, reduces hospitalizations, and induces biventricular reverse remodeling. However, the effects of CCM on MEE and global longitudinal strain (GLS) are still unknown; therefore, this study aims to evaluate whether CCM therapy can improve the MEE of patients with HFrEF., Methods: We enrolled 25 patients with HFrEF who received an Optimizer Smart implant (the device that develops CCM therapy) between January 2018 and January 2021. Clinical and echocardiographic evaluations were performed in all patients 24 h before and six months after CCM therapy., Results: At six months, follow-up patients who underwent CCM therapy showed an increase of left ventricular ejection fraction (30.8 ± 7.1 vs. 36.1 ± 6.9%; p = 0.032) as well a rise of GLS 10.3 ± 2.7 vs. -12.9 ± 4.2; p = 0.018), of MEE (32.2 ± 10.1 vs. 38.6 ± 7.6 mL/s; p = 0.013) and of MEE index (18.4 ± 6.3 vs. 24.3 ± 6.7 mL/s/g; p = 0.022)., Conclusions: CCM therapy increased left ventricular performance, improving left ventricular ejection fraction, GLS, as well as MEE and MEEi., Competing Interests: The authors declare no conflict of interest.

Background: To investigate the effects of the COVID-19 lockdowns on the vasculopathic population. Methods: The Divisions of Vascular Surgery of the southern Italian peninsula joined this multicenter retrospective study. Each received a 13-point questionnaire investigating the hospitalization rate of vascular patients in the first 11 months of the COVID-19 pandemic and in the preceding 11 months. Results: 27 out of 29 Centers were enrolled. April-December 2020 (7092 patients) vs. 2019 (9161 patients): post-EVAR surveillance, hospitalization for Rutherford category 3 peripheral arterial disease, and asymptomatic carotid stenosis revascularization significantly decreased (1484 (16.2%) vs. 1014 (14.3%), p = 0.0009; 1401 (15.29%) vs. 959 (13.52%), p = 0.0006; and 1558 (17.01%) vs. 934 (13.17%), p < 0.0001, respectively), while admissions for revascularization or major amputations for chronic limb-threatening ischemia and urgent revascularization for symptomatic carotid stenosis significantly increased (1204 (16.98%) vs. 1245 (13.59%), p < 0.0001; 355 (5.01%) vs. 358 (3.91%), p = 0.0007; and 153 (2.16%) vs. 140 (1.53%), p = 0.0009, respectively). Conclusions: The suspension of elective procedures during the COVID-19 pandemic caused a significant reduction in post-EVAR surveillance, and in the hospitalization of asymptomatic carotid stenosis revascularization and Rutherford 3 peripheral arterial disease. Consequentially, we observed a significant increase in admissions for urgent revascularization for symptomatic carotid stenosis, as well as for revascularization or major amputations for chronic limb-threatening ischemia.

In the era of coronavirus disease 2019 (COVID-19), the management of cardiac implantable electronic devices infections with concomitant viral infection has not been completely defined yet. In this explorable context, we report the first experience of a Cardiac resynchronization therapy with defibrillator (CRT-D) implantation after transvenous lead extraction for endocarditis in a COVID-19 patient. We describe both the measures and procedures implemented to reduce the cross-infection in the operating room and our clinical practice to improving procedure effectiveness on patient care., (© 2021 Wiley Periodicals LLC.)

Introduction: In the context of randomized clinical trials, subcutaneous implantable cardiac defibrillators (S-ICDs) are non-inferior to transvenous ICDs (T-ICDs) concerning device-related complications or inappropriate shocks in patients with an indication for defibrillator therapy and not in need of pacing. We aimed at describing the clinical features of patients who underwent S-ICD implantation in our clinical practice, as well as the ICD-related complications and the inappropriate therapies among S-ICD vs. T-ICD recipients during a long-term follow-up., Materials and Methods: All patients undergoing ICD, both S-ICD and TV-ICD, at Monaldi Hospital from January 1, 2015 to January 1, 2019 and followed up at our institution were included in the present analysis. The clinical variables associated with S-ICD implantation were evaluated by logistic regression analyses. We collected the ICD inappropriate therapies, ICD-related complications (including both pulse generator and lead-related complications), ICD-related infections, appropriate ICD therapies, and overall mortality. Kaplan-Meier (KM) analyses were performed to assess the risk of clinical outcome events between the two subgroups. A time-dependent Cox regression analysis was performed to adjust the results., Results: Total 607 consecutive patients (mean age 53.8 ± 16.8, male 77.8%) with both TV-ICD ( n : 290, 47.8%) and S-ICD ( n : 317, 52.2%), implanted and followed at our center for a mean follow-up of 1614 ± 1018 days, were included in the study. At multivariate logistic regression analysis, an independent association between S-ICD implantation and ionic channel disease [ OR : 6.01 (2.26-15.87); p < 0.0001 ] and ischemic cardiomyopathy [ OR : 0.20 (0.12-0.35); p < 0.0001 ] was shown. The KM analysis did not show a significantly different risk of the inappropriate ICD therapies ( log rank p = 0.64 ) between the two subgroups; conversely, a significant increase in the risk of ICD-related complications ( log rank p = 0.02 ) and infections ( log rank p = 0.02 ) in TV-ICD group was shown. The adjusted risk for ICD-related infections [ OR : 0.07 (0.009-0.55), p = 0.01 ] and complications [0.31 (0.12-0.81) , p = 0.01 ] was significantly lower among patients with S-ICD., Conclusions: The choice to implant S-ICD was mainly driven by younger age and the presence of ionic channel disease; conversely ischemic cardiomyopathy reduces the probability to use this technology. No significant differences in inappropriate ICD therapies were shown among S-ICD vs. TV-ICD group; moreover, S-ICD is characterized by a lower rate of infectious and non-infectious complications leading to surgical revision or extraction., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Russo, Rago, Ruggiero, Cavaliere, Bianchi, Ammendola, Papa, Tavoletta, De Vivo, Golino, D'Onofrio and Nigro.)

Aim: Remote monitoring (RM) of implantable cardiac devices has enabled continuous surveillance of atrial high rate episodes (AHREs) with well-recognized clinical benefits. We aimed to add evidence on the role of the RM as compared to conventional follow-up by investigating the interval from AHRE onset to physician's evaluation and reaction time in actionable episodes., Methods and Results: A total of 97 dual-chamber pacemaker recipients were followed with RM (RM-ON group; N  = 64) or conventional in-office visits (RM-OFF group; N  = 33) for 18 months. In-office visits were scheduled at 1, 6, 12, and 18 months in the RM-OFF group and at 1 and 18 months in the RM-ON group. The overall AHRE rate was 1.98 per patient-year (95% confidence interval [CI], 1.76-2.20) with no difference between the two groups (RM-ON vs. RM-OFF weighted-HR, 0.88; CI, 0.36-2.13; p  = .78). In the RM-ON group, 100% AHREs evaluated within 11 days from onset, and within 202 days in the RM-OFF group, with a median evaluation delay 79 days shorter in the RM-ON group versus the RM-OFF group ( p  < .0001). Therapy adjustment in actionable AHREs occurred 77 days earlier in the RM-ON group versus the control group ( p  < .001). In the RM-ON group, there were 50% less in-office visits as compared to the RM-OFF group ( p  < .001)., Conclusions: In our pacemaker population with no history of atrial fibrillation, RM allowed significant reduction of AHRE evaluation delay and prompted treatment of actionable episodes as compared to biannual in-office visit schedule., Competing Interests: P.N. is an employee of BIOTRONIK Italia. The other authors have no major conflict of interest to disclose., (© 2022 The Authors. Journal of Arrhythmia published by John Wiley & Sons Australia, Ltd on behalf of the Japanese Heart Rhythm Society.)

Objectives: Surgical site infections (SSIs) in lower extremity vascular surgeries, post-groin incision, are not only common complications and significant contributors to patient mortality and morbidity, but also major financial burdens on healthcare systems and patients. In spite of recent advances in pre- and post-operative care, SSI rates in the vascular surgery field remain significant. However, compliant antibiotic therapy can successfully reduce the SSI incidence pre- and post-surgery., Methods: In October 2021, we conducted a systematic literature review using OVID, PubMed, and EMBASE databases, centered on studies published between January 1980 and December 2020. The review adhered to the Preferred Reporting Items for Systematic Reviews and Meta Analyses checklist. Inclusion/exclusion criteria have been carefully selected and reported in the text. For analyses, we calculated 95% confidence intervals (CI) and weighted odds ratios to amalgamate control and study groups in publications. We applied The Cochrane Collaboration tool to assess bias risk in selected studies., Results: In total, 592 articles were identified. After the removal of duplicates and excluded studies, 36 full-texts were included for review., Conclusions: The review confirmed that antibiotic therapy, administered according to all peri-operative protocols described, is useful in reducing groin SSI rate in vascular surgery.

Introduction: Little is known about the clinical performance of single-chamber leadless pacemaker (LLPM) in patients without atrial fibrillation (AF) as pacing indication. The aim of this study was to describe the clinical characteristics of patients who underwent single chamber LLPM implantation at three tertiary referral centers and to compare the safety and effectiveness of the single-chamber LLPM among patients with or without AF., Materials and Methods: All the consecutive patients who underwent LLPM implantation at three referral centers were analyzed. The indications to LLPM in a real-world setting were described. The study population was divided into two groups according to AF as pacing indication. We assessed the procedure-related complications; moreover, we compared syncope, cardiac hospitalization, pacemaker syndrome, and all-cause death recurrence during the follow-up between patients with and without AF as pacing indication., Results: A total of 140 consecutive patients (mean age, 76.7 ± 11.24 years, men 64.3%) were included in the study. The indication to implantation of LLPM was permanent AF with slow ventricular response ( n : 67; 47.8%), sinus node dysfunction ( n : 25; 17.8%), third atrioventricular block (AVB) ( n : 20; 14.2%), second-degree AVB ( n : 18; 12.8%), and first degree AVB ( n : 10; 7.1%). A total of 7 patients (5%) experienced perioperative complications with no differences between the AF vs. non-AF groups. During a mean follow-up of 606.5 ± 265.9 days, 10 patients (7.7%) died and 7 patients (5.4%) were reported for cardiac hospitalization; 5 patients (3.8%) experienced syncope; no patients showed pacemaker syndrome. No significant differences in the clinical events between the groups were shown. The Kaplan-Meier analysis for the combined endpoints did not show significant differences between the AF and non-AF groups [hazard ratio (HR): 0.94, 95% CI: 0.41-2.16; p = 0.88]., Conclusion: Our real-world data suggest that LLPM may be considered a safe and reasonable treatment in patients without AF in need of pacing. Further studies are needed to confirm these preliminary results., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Russo, D'Andrea, De Vivo, Rago, Manzo, Bocchetti, Papa, Giordano, Ammendola, Sarubbi, Golino, D'Onofrio and Nigro.)

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is an effective alternative to the transvenous ICD. No study has yet compared S-ICD and transvenous ICD by assessing patient acceptance as a patient-centered outcome., Objective: To evaluate the patient acceptance of the S-ICD and to investigate its association with clinical and implantation variables. In patients with symptomatic heart failure and reduced ejection fraction (HFrEF), the acceptance of the S-ICD was compared with a control group of patients who received a transvenous ICD., Methods: Patient acceptance was calculated with the Florida Patient Acceptance Survey (FPAS) which measures four factors: return to function (RTF), device-related distress (DRD), positive appraisal (PA), and body image concerns (BIC). The survey was administered 12 months after implantation., Results: 176 patients underwent S-ICD implantation. The total FPAS and the single factors did not differ according to gender, body habitus, or generator positioning. Patients with HFrEF had lower FPAS and RTF. Younger patients showed better RTF (75 [56-94] vs. 56 [50-81], p = .029). Patients who experienced device complications or device therapies showed higher DRD (40 [35-60] vs. 25 [10-50], p = .019). Patients with HFrEF receiving the S-ICD had comparable FPAS, RTF, DRD, and BIC to HFrEF patients implanted with the transvenous ICD while exhibited significantly better PA (88 [75-100] vs. 81 [63-94], p = .02)., Conclusions: Our analysis revealed positive patient acceptance of the S-ICD, even in groups at risk of more distress such as women or patients with thinner body habitus, and regardless of the generator positioning. Among patients receiving ICDs for HFrEF, S-ICD was associated with better PA versus transvenous ICD., (© 2021 Wiley Periodicals LLC.)

Background: The traditional technique for subcutaneous implantable cardioverter defibrillator (S-ICD) implantation involves three incisions and a subcutaneous (SC) pocket. An intermuscular (IM) 2-incision technique has been recently adopted., Aims: We assessed acute defibrillation efficacy (DE) of S-ICD (DE ≤65 J) according to the implantation technique., Methods: We analyzed consecutive patients who underwent S-ICD implantation and DE testing at 53 Italian centers. Regression analysis was used to determine the association between DFT and implantation technique., Results: A total of 805 patients were enrolled. Four groups were assessed: IM + 2 incisions (n = 546), SC + 2 incisions (n = 133), SC + 3 incisions (n = 111), and IM + 3 incisions (n = 15). DE was ≤65 J in 782 (97.1%) patients. Patients with DE ≤65 J showed a trend towards lower body mass index (25.1 vs. 26.5; p = .12), were less frequently on antiarrhythmic drugs (13% vs. 26%; p = .06) and more commonly underwent implantation with the 2-incision technique (85% vs. 70%; p = .04). The IM + 2-incision technique showed the lowest defibrillation failure rate (2.2%) and shock impedance (66 Ohm, interquartile range: 57-77). On multivariate analysis, the 2-incision technique was associated with a lower incidence of shock failure (hazard ratio: 0.305; 95% confidence interval: 0.102-0.907; p = .033). Shock impedance was lower with the IM than with the SC approach (66 vs. 70 Ohm p = .002) and with the 2-incision than the 3-incision technique (67 vs. 72 Ohm; p = .006)., Conclusions: In a large population of S-ICD patients, we observed a high defibrillation success rate. The IM + 2-incision technique provides lower shock impedance and a higher likelihood of successful defibrillation., (© 2021 The Authors. Journal of Cardiovascular Electrophysiology Published by Wiley Periodicals LLC.)

Background: Psychological stress and anxiety, such those generated by forced quarantine, affect gastrointestinal symptoms course in patients with functional gastrointestinal disorders. Thus, our aim was to assess, in a cohort of patients regularly followed up in a devoted outpatient clinic of Southern Italy, the association between their gastrointestinal symptoms changes, stress, and anxiety reported during the Italian lockdown., Methods: We recruited patients from the outpatient clinic of the University of Salerno, devoted to functional gastrointestinal disorders, selecting only patients for whom an evaluation was available in the last 6 months before the lockdown. Gastrointestinal symptoms were evaluated at each visit through standardized questionnaire and pooled in a database. On 45th days from the beginning of the lockdown, patients were re-assessed by phone with the same questionnaire. Anxiety and stress levels were assessed through a self-administered online questionnaire based on Generalized Anxiety Disorder 7 test and Perceived Stress Scale 10 test., Key Results: The intensity-frequency scores of several upper gastrointestinal symptoms improved (Wilcoxon test <0.05). Higher anxiety levels had a higher risk of worsening chest pain (OR 1.3 [1.1-1.7]), waterbrash (OR 1.3 [1.0-1.7]), epigastric burning (OR 1.3 [1.0-1.6]), and abdominal pain (OR 1.6 [1.0-2.3]). When compared to the interval preceding the outbreak, half of the patients declared their symptoms remained unchanged, 13.6% worsened, and 36.4% improved., Conclusions and Inferences: During the COVID-19 quarantine, there was an improvement of the majority of upper gastrointestinal symptoms in our patients, and anxiety seems an important risk of worsening few of them., (© 2021 John Wiley & Sons Ltd.)

Infective endocarditis (IE) is a rare disease with a significant impact and an increasing mortality despite earlier diagnosis and surgical intervention. It is related to several and the main etiological agents are the Gram-positive cocci. The new guidelines propose new diagnostic criteria that consider the potentiality on integrated multimodality imaging. Echocardiography (TTE) plays a key role for the diagnosis of IE and must be performed as soon as IE is suspected. It allows to identify vegetation, abscess, new dehiscence of prosthetic valve and assesses the number, size, shape, location, echogenicity and mobility of vegetations so it also useful for prediction embolic risk. Transesophageal echocardiography (TEE) is indicated when TTE is positive or non diagnostic, in case of suspected complications and when intracardiac device leads are present. We underline the increasing role of three-dimensional (3D) echocardiography in overcoming the limit of 2DTEE in selecting the maximum true diameter of irregular masses (ie, vegetation). We also underline the diagnostic value of multislice computed tomograpfy (MSCT), cerebral magnetic resonance (RMI) and nuclear imaging and also emphasize the emerging role of particular types of endocarditis specially Lead Endocarditis. The aim of this review is to provide an overview of the imaging techniques useful for the diagnosis and identification of any complications. In our opinion, the management of IE is complex, based on an "Endocarditis team " composed by several specialist and an integrated multimodality imaging is essential for the diagnostic approach., Competing Interests: There are no conflicts of interest., (Copyright: © 2020 Journal of Cardiovascular Echography.)

Aims: Implantable cardioverter defibrillator (ICD) shocks are associated with a subsequent increased risk of death, and an elevation of cardiac enzymes has been measured after defibrillation testing (DFT). In an experimental swine study, subcutaneous ICD (S-ICD) shocks caused less myocardial damage than traditional ICD shocks. The aim of our study was to investigate the association between S-ICD shock and acute cardiac damage in humans, as evaluated by means of sensitive and highly specific circulating biomarkers., Methods and Results: We calculated the variation in the serum levels of high-sensitivity cardiac troponin I (hs-CTnI) and creatine kinase-MB mass concentration (CK-MB mass), measured before and after an S-ICD shock delivered during intraoperative DFT. We also measured the degree of haemodynamic stress, as the variation in the serum levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP) and copeptin (CP), after the S-ICD shock. We analysed 30 consecutive patients who received an S-ICD and who underwent DFT by means of a single 65 J shock. The levels of biomarkers did not change from baseline to 1 h post-shock, i.e. hs-CTnI (from 0.029 ± 0.005 ng/mL to 0.030 ± 0.005 ng/mL, P = 0.079) and CK-MB mass (from 1.37 ± 0.17 ng/mL to 1.41 ± 0.18, P = 0.080) and remained stable 6 and 24 h after DFT. The plasma NT-proBNP did not change, whereas CP levels were significantly higher at 1 h post-shock evaluation. However, 6 h after DFT, the levels had returned to the baseline and remained stable at 24 h., Conclusion: The S-ICD shock did not seem to cause myocardial injuries. Although CP levels temporarily rose after DFT, they returned to basal levels within 6 h, which suggests that DFT does not have long-term prognostic implications. ICD shocks are associated with a subsequent increased risk of death, and an elevation of cardiac enzymes has been measured after DFT. We showed that serum levels of biomarkers of myocardial damage did not increase after high-energy DFT in patients who had undergone S-ICD device implantation. This suggests that S-ICD shock does not have long-term prognostic implications.

Background: Remote Monitoring (RM) has been introduced for several years and nowadays most pacemakers are equipped with such a technology. RM can provide early detection of high atrial rate episodes (AHREs) onset and enable prompt medical intervention. However, there are still little data on the clinical reactions triggered by the AHRE detected by RM of pacemaker recipients and on their possible benefit on patients' outcome., Methods/design: The RAPID study is a multicenter, prospective, non-interventional study designed to compare the time from onset to first physician's evaluation of AHRE episode with arrhythmic burden ≥5% (72 minutes) for pacemaker recipients without atrial fibrillation history, between patients followed with RM or conventionally with annual in-hospital visits. A total of 98 patients with implanted dual-chamber pacemaker, assigned to RM-OFF or RM-ON according to ordinary clinical site practice, will be followed for a total of 18 months. After the implant, patients will perform their first in-hospital follow-up visit at 1 month and then, in the RM-OFF group, patients will perform an in-hospital FU every 6 months, while in the active group, patients will be continuously monitored via RM until study termination. All AHREs and consequent medical interventions will be collected over the entire study period., Discussion: The ongoing RAPID study will provide additional information on the role of RM in the management of AHRE detected in pacemaker patients without documented atrial fibrillation history in ordinary clinical practice.

Background: Rivaroxaban is the first novel oral anticoagulant to receive regulatory approval for non-valvular atrial fibrillation (NVAF) patients who require cardioversion. The MonaldiVert real life experience showed positive benefit-risk profile of short term rivaroxaban administration for transesophageal echocardiogram guided cardioversion in patients who had not achieved adequate pre-procedural vitamin K antagonist (VKA) anticoagulation., Methods: Aim of our study was to perform a budget impact analysis of MonaldiVert anticoagulation strategy for direct current cardioversion in NVAF patients and to compare the following costs borne by the Regional Healthcare System (RHS) with those for a hypothetical cohort of identical patients underwent from the beginning to early rivaroxaban treatment before direct current cardioversion., Results: The mean costs per each NVAF patient treated with VKA strategy and rivaroxaban rescue strategy were € 134.53 and € 189.83, respectively. Considering a hypothetical scenario in which all study population would be treated from the beginning with rivaroxaban (rivaroxaban early strategy), the mean cost per patient would have been € 81.11. The total cost borne by the RHS, including the cost of the cardioversion procedure, for the two therapeutic strategies carried out at Monaldi Hospital (VKA strategy and Rivaroxaban rescue strategy) was € 88,458.53. The total cost would be borne by the RHS for rivaroxaban early strategy, if applied to all study population, would have been € 69,989.15 with a saving of € 18,469.38 compared to the actually applied strategy., Conclusions: Rivaroxaban rescue strategy for transesophageal echocardiography guided direct current cardioversion in NVAF patients, who had not achieved adequate pre-procedural VKA anticoagulation, is an effective and safe strategy, which allows to not delay the procedure, reducing times and wastage of cardioversion slots, without substantial costs increase.

Background: Remote monitoring (RM) of cardiac implantable electronic devices has been demonstrated to improve outpatient clinic workflow and patient management. However, few data are available on the socioeconomic impact of RM., Objective: The aim of this study was to assess the costs and benefits of RM compared with standard care (SC)., Methods: We used 12-month patient data from the Health Economics Evaluation Registry for Remote Follow-up (TARIFF) study (N = 209; RM: n = 102 (48.81%); SC: n = 107 (51.19%)). Cost comparison was made from 2 perspectives: the health care system (HCS) and patients. The use of health care resources was defined on the basis of hospital clinical folders. Out-of-pocket expenses were reported directly by patients., Results: HCS perspective: The overall mean annual cost per patient in the SC group (€1044.89 ± €1990.47) was significantly higher than in the RM group (€482.87 ± €2488.10) (P < .0001), with a reduction of 53.87% being achieved in the RM group. The primary driver of cost reduction was the cost of cardiovascular hospitalizations (SC: €`886.67 ± €1979.13 vs RM: €432.34 ± €2488.10; P = .0030). Patient and caregiver perspective: The annual cost incurred by patients was significantly higher in the SC group than in the RM group (SC: €169.49 ± €189.50 vs RM: €56.87 ± €80.22; P < .0001). Patients' quality-adjusted life-years were not significantly different between the groups. Provider perspective: The total number of inhospital device follow-up visits was reduced by 58.78% in the RM group., Conclusion: RM of patients with cardiac implantable electronic devices (CIEDs) is cost saving from the perspectives of the HCS, patients, and caregivers. Introducing appropriate reimbursements will make RM sustainable even for the provider, i.e. the hospitals which provide the service and encourage widespread adoption of RM., (Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Major Depressive disorder (MDD) is often accompanied by cognitive deficits, involving attention, learning, memory and executive functioning. Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin and Noradrenaline Reuptake Inhibitors (SNRIs) show efficacy on affective symptoms, but it is unclear whether or not they improve cognitive symptoms., Methods: We carried out a 12 week-prospective observational study in two cohorts of recurrent moderate-severe partial responder MDD patients, to test the hypothesis that SSRIs and/or SNRIs may affect cognitive symptoms and assess whether or not such an effect was correlated to their effect on affective symptoms. All patients underwent cognitive and neuropsychiatric assessment at baseline, 4- and 12-week follow-up. Thirty-three patients in the SSRI- and sixteen patients in the SNRI-cohort completed the follow-up., Results: Both SSRIs and SNRIs reduced affective symptoms and improved global cognitive function. Both SSRIs and SNRIs improved executive function and verbal memory. Global cognitive function, verbal memory and executive function improved both in full and partial responder patients. Finally, there was no correlation between baseline Mini Mental State Examination, Montreal Cognitive Assessment and Frontal Assessment Battery scores and the mean change in Hamilton Psychiatric Rating scale for Depression or Beck Depression Inventory at the end of the 12 weeks of treatment., Conclusion: Present data show that SSRIs and SNRIs improve cognitive symptoms in MDD independently from their efficacy on affective symptoms. Affective and cognitive symptoms may represent distinct psychopathological dimensions of MDD with different response to antidepressant drugs.

Purpose: Patients with permanent atrial fibrillation (AF) who undergo cardiac resynchronization therapy (CRT) may spontaneously recover sinus rhythm during follow-up. We tested the feasibility and efficacy of electrical cardioversion attempted after 3 months of CRT in patients with permanent AF and measured the long-term maintenance of sinus rhythm., Methods: Twenty-eight consecutive patients with permanent AF in whom CRT defibrillators had been implanted were scheduled for internal electrical cardioversion after 3 months (group A) and were compared with a control group of 27 patients (group B)., Results: In group A, 22 patients (79 %) were eligible for cardioversion; sinus rhythm was restored in 18 (82 %) of these, with no procedural complications. After 12 months, 16 patients (58 %) in group A were in sinus rhythm, compared with one group B patient who spontaneously recovered sinus rhythm (4 %, p < 0.001). On 12-month evaluation, ejection fraction had improved in both groups, but a reduction in left ventricular end-systolic volume was recorded only in group A patients (p = 0.018 versus baseline)., Conclusions: In patients with permanent AF, the rhythm control strategy consisting of internal cardioversion, performed by means of the implanted cardioverter-defibrillator after 3 months of CRT, was associated with a high rate of sinus rhythm resumption on long-term follow-up and with a better echocardiographic response to CRT than that seen in patients treated according to a rate control strategy.