Understanding the protective effect of social support on depression symptomatology from a longitudinal network perspective.

BACKGROUND: Higher social support protects people from developing mental disorders. Limited evidence is available on the mechanism through which social support plays this protective role. OBJECTIVE: To investigate the stress-buffering process of social support on depressive symptoms using a novel longitudinal dynamic symptom network approach. METHODS: A total of 4242 adult participants who completed the first two waves (from May to October 2020) of the International Covid Mental Health Survey were included in the study. Cross-lagged panel network modelling was used to estimate a longitudinal network of self-reported social support, loneliness and depressive symptoms. Standardised regression coefficients from regularised cross-lagged regressions were estimated as edge weights of the network. FINDINGS: The results support a unidirectional protective effect of social support on key depressive symptoms, partly mediated through loneliness: A higher number of close confidants and accessible practical help was associated with decreased anhedonia (weight=-0.033) and negative self-appraisal symptoms (weight=-0.038). Support from others was also negatively associated with loneliness, which in turn associated with decreased depressed mood (weight=0.086) and negative self-appraisal (weight=0.077). We identified a greater number of direct relationships from social support to depressive symptoms among men compared with women. Also, the edge weights from social support to depression were generally stronger in the men's network. CONCLUSIONS: Reductions in negative self-appraisal might function as a bridge between social support and other depressive symptoms, and, thus, it may have amplified the protective effect of social support. Men appear to benefit more from social support than women. CLINICAL IMPLICATIONS: Building community-based support networks to deliver practical support, and loneliness reduction components are critical for depression prevention interventions after stressful experiences.

Mental health across two years of the COVID-19 pandemic: a 5-wave longitudinal study in Germany.

The COVID-19 pandemic has been negatively associated with mental health. However, little is known about the temporal dynamics of mental health in the longer term of the pandemic. We aimed to investigate symptom levels and changes of depression, anxiety, posttraumatic stress, and loneliness spanning two years of the pandemic; and to examine associated risk factors. This five-wave, longitudinal online study from May 2020 to April 2022 included 636 adults (Mage = 39.5 years, SD = 16.11; 84.1% female) from the German general population who completed the international COVID-19 Mental Health Survey. Symptoms of anxiety (Generalized Anxiety Disorder-7; GAD-7), depression (Patient Health Questionnaire-9; PHQ-9), posttraumatic stress (PTSD Checklist for DSM-5; PCL-5), and loneliness ("Do you feel lonely?") were assessed using mixed-effects models. Associations with anxiety and depressive symptoms were examined with having children, student status, financial worries, contamination fear, and loneliness. PHQ-9, GAD-7, PCL-5, and loneliness scores overall decreased throughout the two-year period of the pandemic but exhibited an increase during two national lockdowns. Controlled for significant associations with female gender and younger age, increased PHQ-9 and GAD-7 scores were associated with contamination fear, financial worries, and loneliness. No associations were found with having children and student status. Symptoms of depression, anxiety, posttraumatic stress, and loneliness decreased over time but varied along with the dynamics of the pandemic. Longitudinal monitoring of mental health in vulnerable subgroups is required, especially those of younger age, females, and the financially insecure.

Longitudinal impact of the COVID19 pandemic on mental health in a general population sample in France: Evidence from the COMET Study.

BACKGROUND: To study the longitudinal impact of co-occurring mental health problems, and to identify vulnerable groups in need of mental health support during the COVID-19 pandemic. METHODS: Analyses were based on data from 681 French participants in the international COVID-19 Mental Health Study, collected at four times (05/2020-04/2021). Symptoms of depression, anxiety and post-traumatic stress disorder (PTSD) were assessed using the Patient Health Questionnaire 9, the Generalized Anxiety Disorder-7 and the PTSD Check List for DSM-5. We performed k-means for longitudinal data to build trajectories of adults' depression, anxiety and PTSD symptoms and identify subgroups psychologically vulnerable. We then assessed whether mental health trajectories were predicted by lockdown regulations. RESULTS: A high and a low cluster of mental health scores were identified. In both groups, mental health scores varied significantly across time. Levels of all mental health scores were lowest when COVID-19-related restrictions were lifted and highest when restrictions were in place, except for PTSD. No scores returned to the previous level or the initial level of mental health (p < 0.05). Participants with high levels of symptoms were characterized by younger age (OR: 0.98, 95 % CI: 0.97-0.99), prior history of mental disorders (OR: 3.46, 95 % CI: 2.07-5.82), experience of domestic violence (OR: 10.54, 95 % CI: 1.54-20.68) and medical issues (OR: 2.16, 95 % CI: 1.14-4.03). LIMITATIONS: Pre-pandemic data were not available and the sample was recruited mainly by snowball sampling. CONCLUSION: This study revealed subtle differences in the evolution of symptom trajectories during the first year of the Covid-19 pandemic, and highlighted several characteristics associated with the two clusters.

Resilience of people with chronic medical conditions during the COVID-19 pandemic: a 1-year longitudinal prospective survey.

BACKGROUNDS: Individuals with chronic medical conditions are considered highly exposed to COVID-19 pandemic stress, but emerging evidence is demonstrating that resilience is common even among them. We aimed at identifying sustained resilient outcomes and their predictors in chronically ill people during the first year of the pandemic. METHODS: This international 4-wave 1-year longitudinal online survey included items on socio-demographic characteristics, economic and living situation, lifestyle and habits, pandemic-related issues, and history of mental disorders. Adherence to and approval of imposed restrictions, trust in governments and in scientific community during the pandemic were also investigated. The following tools were administered: the Patient Health Questionnaire, the Generalized Anxiety Disorder scale, the PTSD Checklist DSM-5, the Oslo Social Support Scale, the Padua Inventory, and the Portrait Values Questionnaire. RESULTS: One thousand fifty-two individuals reporting a chronic condition out of 8011 total participants from 13 countries were included in the study, and 965 had data available for the final model. The estimated probability of being "sustained-resilient" was 34%. Older male individuals, participants employed before and during the pandemic or with perceived social support were more likely to belong to the sustained-resilience group. Loneliness, a previous mental disorder, high hedonism, fear of COVID-19 contamination, concern for the health of loved ones, and non-approving pandemic restrictions were predictors of not-resilient outcomes in our sample. CONCLUSIONS: We found similarities and differences from established predictors of resilience and identified some new ones specific to pandemics. Further investigation is warranted and could inform the design of resilience-building interventions in people with chronic diseases.

Symptoms of anxiety and depression during the COVID-19 pandemic in six European countries and Australia - Differences by prior mental disorders and migration status.

BACKGROUND: Little is known about changes of mental health during the COVID-19 pandemic in potentially disadvantaged groups. We investigated changes in anxiety and depression symptoms during the first year of the pandemic in six European countries and Australia by prior mental disorders and migration status. METHODS: Overall, 4674 adults answered a web-based survey in May-June 2020 and were followed by three repeated surveys up to February 2021. Information on psychosocial, financial and demographic, living conditions, prior mental disorders, depression and anxiety symptoms during the pandemic and migration status was collected. Weighted general estimation equations modelling was used to investigate the association between prior mental disorders, migration status, and symptoms over time. RESULTS: Most participants were <40 years old (48%), women (78%) and highly educated (62%). The baseline prevalence of depressive and anxiety symptoms ranged between 19%-45% and 13%-35%, respectively. In most countries, prevalence rates remained unchanged throughout the pandemic and were higher among people with prior mental disorders than without even after adjustment for several factors. We observed interactions between previous mental disorders and symptoms of anxiety or depression over time in two countries. No difference by migration status was noted. LIMITATIONS: Convenience sampling limits generalizability. Self-assessed symptoms of depression and anxiety might involve some misclassification. CONCLUSIONS: Depression and anxiety symptoms were worse among individuals with prior mental disorders than without, but there was no clear trend of worsening mental health in the observed groups during the observed period.

Prevalence of mental disorders in refugees and asylum seekers: a systematic review and meta-analysis.

Background: Studies have identified high rates of mental disorders in refugees, but most used self-report measures of psychiatric symptoms. In this study, we examined the percentages of adult refugees and asylum seekers meeting diagnostic criteria for major depressive disorder (MDD), post-traumatic stress disorder, bipolar disorder (BPD), and psychosis. Methods: A systematic literature search in three databases was conducted. We included studies examining the prevalence of MDD, post-traumatic stress disorder, BPD, and psychosis in adult refugees according to a clinical diagnosis. To estimate the pooled prevalence rates, we performed a meta-analysis using the Meta-prop package in Stata (PROSPERO: CRD42018111778). Results: We identified 7048 records and 40 studies (11 053 participants) were included. The estimated pooled prevalence rates were 32% (95% CI 26-39%; I 2 = 99%) for MDD, 31% (95% CI 25-38%; I 2 = 99.5%) for post-traumatic stress disorder, 5% (95% CI 2-9%; I 2 = 97.7%) for BPD, and 1% (95% CI 1-2%; I 2 = 0.00%) for psychosis. Subgroup analyses showed significantly higher prevalence rates of MDD in studies conducted in low-middle income countries (47%; 95% CI 38-57%, p = 0.001) than high-income countries studies (28%; 95% CI 22-33%), and in studies which used the Mini-International Neuropsychiatric Interview (37%; 95% CI 28-46% p = 0.05) compared to other diagnostic interviews (26%; 95% CI 20-33%). Studies among convenience samples reported significant (p = 0.001) higher prevalence rates of MDD (35%; 95% CI 23-46%) and PTSD (34%; 95% CI 22-47%) than studies among probability-based samples (MDD: 30%; 95% CI 21-39%; PTSD: 28%; 95% 19-37%). Conclusions: This meta-analysis has shown a markedly high prevalence of mental disorders among refugees. Our results underline the devastating effects of war and violence, and the necessity to provide mental health intervention to address mental disorders among refugees. The results should be cautiously interpreted due to the high heterogeneity.

Impact of Longitudinal Social Support and Loneliness Trajectories on Mental Health during the COVID-19 Pandemic in France.

(1) Background: Little is known about how the COVID-19 pandemic has impacted social support and loneliness over time and how this may predict subsequent mental health problems. This study aims to determine longitudinal trajectories of social support and loneliness in the French general population during the first year of the COVID-19 pandemic and study whether variations in these trajectories are associated with symptoms of depression and anxiety; (2) Methods: Analyses were based on data from 681 French participants in the international COVID-19 Mental Health Study (COMET) study, collected at four periods of time between May 2020 and April 2021. Group-based trajectory modelling (GBTM) was used to determine social support and loneliness trajectories. Associations between the identified trajectories and symptoms of depression and anxiety, measured with the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder scale (GAD-7), were tested through multivariate linear regression models; (3) Results: Social support trajectories revealed four stable groups: 'poor' (17.0%), 'moderate' (42.4%), 'strong' (35.4%) and 'very strong' (5.1%). Loneliness trajectories also identified four groups: 'low stable' (17.8%), 'low rising' (40.2%), 'moderate stable' (37.6%) and 'high rising' (5.0%). Elevated symptoms of depression were associated with poor social support as well as all identified loneliness trajectories, while high levels of anxiety were associated with moderate stable and high rising loneliness trajectories; (4) Conclusions: High and increasing levels of loneliness are associated with increased symptoms of depression and anxiety during the pandemic. Interventions to address loneliness are essential to prevent common mental health problems during the pandemic and afterwards.

Ghrelin peptide improves glial conditioned medium effects on neuronal differentiation of human adipose mesenchymal stem cells.

The influences of ghrelin on neural differentiation of adipose-derived mesenchymal stem cells (ASCs) were investigated in this study. The expression of typical neuronal markers, such as protein gene product 9.5 (PGP9.5) and Microtubule Associated Protein 2 (MAP2), as well as glial Fibrillary Acid Protein (GFAP) as a glial marker was evaluated in ASCs in different conditions. In particular, 2 µM ghrelin was added to control ASCs and to ASCs undergoing neural differentiation. For this purpose, ASCs were cultured in Conditioned Media obtained from Olfactory Ensheathing cells (OEC-CM) or from Schwann cells (SC-CM). Data on marker expression were gathered after 1 and 7 days of culture by fluorescence immunocytochemistry and flow cytometry. Results show that only weak effects were induced by the addition of only ghrelin. Instead, dynamic ghrelin-induced modifications were detected on the increased marker expression elicited by glial conditioned media. In fact, the combination of ghrelin and conditioned media consistently induced a further increase of PGP9.5 and MAP2 expression, especially after 7 days of treatment. The combination of ghrelin with SC-CM produced the most evident effects. Weak or no modifications were found on conditioned medium-induced GFAP increases. Observations on the ghrelin receptor indicate that its expression in control ASCs, virtually unchanged by the addition of only ghrelin, was considerably increased by CM treatment. These increases were enhanced by combining ghrelin and CM treatment, especially at 7 days. Overall, it can be assumed that ghrelin favors a neuronal rather than a glial ASC differentiation.

Prenatal music exposure influences weight, ghrelin expression, and morphology of rat hypothalamic neuron cultures.

Music plays an important role in brain physiology, in some areas related to emotions, food intake and body weight, such as the hypothalamus. There are different frequencies to which it can be tuned, today the most utilized is at 440 Hz, while in the past the 432 Hz frequency was more used to show particular effects on brain. It is known that Ghrelin, a peptide hormone, regulates food intake in the hypothalamus; in a previous paper, we reported that musical stimuli at 432 Hz modified the Ghrelin expression in the rat, increasing beneficial effects on metabolism. In this study, we used this frequency and we focused our attention on body weight, Ghrelin expression, and neuron morphology in hypothalamic cultures. To investigate the role of music, we utilized newborn pups from pregnant rats that were exposed to music stimuli at 432 Hz during the perinatal period and for the postnatal period, some for 3 days (P3) and others for 6 days (P6). Some pups were not exposed to music stimuli (controls). Our results showed that music increased the body weight of pups; in addition, enhanced Ghrelin expression in hypothalamic neurons and their axonal elongation were highlighted by immunocytochemical techniques. Moreover, we found that the positive music effect started in pups at P3 and increased at P6 compared with controls. These results suggest that the musical frequency at 432 Hz could stimulate the orexigenic Ghrelin effects influencing the increase in body weight and affecting the number of hypothalamic neurons expressing Ghrelin.

Effects of Ghrelin on Olfactory Ensheathing Cell Viability and Neural Marker Expression.

Ghrelin (Ghre), a gut-brain peptide hormone, plays an important role in the entire olfactory system and in food behavior regulation. In the last years, it has aroused particular interest for its antioxidant, anti-inflammatory, and anti-apoptotic properties. Our previous research showed that Ghre and its receptor are expressed by peculiar glial cells of the olfactory system: Olfactory Ensheathing Cells (OECs). These cells are able to secrete different neurotrophic factors, promote axonal growth, and show stem cell characteristics. The aim of this work was to study, in an in vitro model, the effect of Ghre on both cell viability and the expression of some neural markers, such as Nestin (Ne), Glial Fibrillary Acid Protein (GFAP), Neuregulin (Neu), and ß-III-tubulin (Tuj1), in primary mouse OEC cultures. The MTT test and immunocytochemical procedures were used to highlight cell viability and marker expression, respectively. Our results demonstrate that Ghre, after 7 days of treatment, exerted a positive effect, stimulating OEC viability compared with cells without Ghre treatment. In addition, Ghre was able to modify the expression of some biomarkers, increasing Neu and Tuj1 expression, while GFAP was constant; on the contrary, the presence of positive Ne cells was drastically reduced after 7 days, and this showed a loss of stem cell characteristic and therefore the possible orientation towards an adult neural phenotype.

Olfactory Ensheathing Cells express both Ghrelin and Ghrelin Receptor in vitro: a new hypothesis in favor of a neurotrophic effect.

Olfactory Ensheathing Cells (OECs) are glial cells able to secrete different neurotrophic growth factors and thus promote axonal growth, also acting as a mechanical support. In the olfactory system, during development, they drive the non-myelinated axons of the Olfactory Receptor Neurons (ORNs) towards the Olfactory Bulb (OB). Ghrelin (Ghre), a gut-brain peptide hormone, and its receptor (GHS-R 1a) are expressed in different parts of the central nervous system. In the last few years, this peptide has stimulated particular interest as results show it to be a neuroprotective factor with antioxidant, anti-inflammatory and anti-apoptotic properties. Our previous studies showed that OB mitral cells express Ghre, thus being able to play an important role in regulating food behavior in response to odors. In this study, we investigated the presence of Ghre and GHS-R 1a in primary mouse OECs. The expression of both Ghre and its receptor was assessed by an immunocytochemical technique, Western Blot and Polymerase Chain Reaction (PCR) analysis. Our results demonstrated that OECs are able to express both Ghre and GHS-R 1a and that these proteins are detectable after extensive passages in vitro; in addition, PCR analysis further confirmed these data. Therefore, we can hypothesize that Ghre and GHS-R 1a interact with a reinforcement function, in the peripheral olfactory circuit, providing a neurotrophic support to the synaptic interaction between ORNs and mitral cells.

Incidence of Long-Term Structural Valve Dysfunction and Bioprosthetic Valve Failure After Transcatheter Aortic Valve Replacement.

Background Long-term data on durability of currently available transcatheter heart valves are sparse. We sought to assess the incidence of long-term (8-year) structural valve dysfunction and bioprosthetic valve failure in a cohort of patients with transcatheter aortic valve replacement ( TAVR ) who reached at least 5-year follow-up. Methods and Results Consecutive patients with at least 5-year follow-up available undergoing TAVR from June 4, 2007 to March 30, 2012 were included. Structural valve dysfunction and bioprosthetic valve failure were defined according to newly standardized European Association of Percutaneous Cardiovascular Interventions/ European Society of Cardiology/European Association for Cardio-Thoracic Surgery criteria and reported as cumulative incidence function to account for the competing risk of death. A total of 288 consecutive patients with a mean age of 80.7±5.3 years and with a mean Society of Thoracic Surgery mortality score of 8.1±5.1% were analyzed. Survival rate at 8 years was 29.8%. Mean pressure gradients decreased from 53.3±15.9 mm Hg (pre- TAVR ) to 10.5±4.5 mm Hg (in-hospital post- TAVR ) ( P<0.001). There was a small, not significant, increase in the transaortic gradient throughout follow-up. Bioprosthetic valve failure was observed in a total of 11 patients (8-year cumulative incidence function: 4.51%; 95% confidence interval , 1.95%-8.76%). Severe and moderate structural valve dysfunctions were reported in 7 patients (8-year cumulative incidence function: 2.39%; 95% confidence interval, 0.77%-5.71%) and 13 patients (8-year cumulative incidence function: 5.87%; 95% confidence interval , 3.06%-9.96%), respectively. Aortic valve reintervention (redo TAVR ) was successfully performed in 2 patients (0.7%) presenting with symptomatic severe restenosis and intraprosthetic regurgitation subsequent to endocarditis. Conclusions In an aged population of patients with symptomatic severe aortic stenosis treated with first-generation bioprostheses, TAVR was associated with a survival rate of 30% but low rates of bioprosthetic valve failure and structural valve dysfunction at 8 years.

Secondary school teachers and mental health competence: Italy-United Kingdom comparison.

AIM: The aim of this study was to evaluate the differences between teachers' knowledge about early psychosis among three different Italian cities and a UK sample. METHODS: The sample consisted of 556 secondary school teachers from three different cities in Italy (Milan, Rome and Lamezia Terme) and London (UK). The research was based on the Knowledge and Experience of Social Emotional Difficulties Among Young People Questionnaire. The Italian version of the questionnaire was used in Italy. RESULTS: Overall, 67.6% of English teachers, 58.5% of Milan's teachers, 41.8% of Rome's teachers and 33.3% of Lamezia Terme's teachers were able to recognize psychotic symptoms from a case vignette. Logistic regression analysis showed that 'city' was the only independent variable significantly related to the correct/wrong answer about diagnosis. CONCLUSIONS: We found statistically significant differences between the three Italian samples and the UK sample regarding teachers' knowledge about first signs of psychosis. English teachers showed a better knowledge than Italian teachers in general. Teachers from Milan, where a specific early detection program was established in 2000, seemed to be more familiar with early signs of psychosis than teachers in the other two Italian towns.

Optimized Screening of Coronary Artery Disease With Invasive Coronary Angiography and Ad Hoc Percutaneous Coronary Intervention During Transcatheter Aortic Valve Replacement.

BACKGROUND: We sought to describe an optimized approach to coronary artery disease (CAD) screening and management in patients undergoing transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: When invasive coronary angiography showed CAD, the treatment strategy and completeness of revascularization was determined based on coronary anatomy. TAVR was performed in the same setting if percutaneous coronary intervention (PCI) was uncomplicated; otherwise TAVR was postponed. A total of 604 patients undergoing CAD screening at the time of TAVR procedure were prospectively included in this study. Severe CAD was found in 136 patients (22.5%). Among patients with severe CAD, 53 patients (8.8%) underwent uncomplicated PCI. After PCI, TAVR was postponed in 2 patients (0.3%). In 83 patients (13.8%), coronary angiography showed severe CAD that was left untreated. After TAVR, all-cause and cardiovascular 30-day mortality rates were 2.4% and 1.4%, respectively. Disabling stroke, myocardial infarction, and life-threatening bleeding occurred in 0.5%, 0.8%, and 4.0% of patients, respectively. Acute kidney injury II or III rate was 3.3%. At 2 years, all-cause mortality rate was 14.1%. Disabling stroke and myocardial infarction occurred in 2.5% and 1.8% of patients, respectively. Patients undergoing TAVR and PCI in the same session had similar rate of the composite of death, disabling stroke, and myocardial infarction when compared with patients without CAD, and patients with severe CAD left untreated (TAVR+PCI: 10.4%; severe CAD left untreated: 15.4%; no-CAD: 14.8%; P=0.765). CONCLUSIONS: In patients undergoing TAVR, screening of CAD with invasive coronary angiography and ad hoc PCI during TAVR is feasible and was not associated with increased periprocedural risks. PCI followed by TAVR in the same session had similar outcomes than TAVR in which PCI was not performed.

MitraClip Implantation for the Treatment of New-Onset Systolic Anterior Motion of the Mitral Valve After Transcatheter Aortic Valve Replacement.

New-onset systolic anterior motion of the anterior mitral valve leaflet in patients undergoing transcatheter aortic valve replacement is a rare pathophysiologic mechanism leading to postprocedural development of mitral regurgitation and, eventually, left ventricular outflow obstruction. We report the first human case of successful MitraClip implantation to treat new-onset systolic anterior motion of the mitral valve after transcatheter aortic valve replacement causing severe obstruction to left ventricular outflow that was unresponsive to standard medical therapy.

Self-Disorders and Clinical High Risk for Psychosis: An Empirical Study in Help-Seeking Youth Attending Community Mental Health Facilities.

Anomalous subjective experiences involving an alteration of the basic sense of self (ie, Self-disorder [SD]) are emerging as a core marker of schizophrenia spectrum disorders with potential impact on current early detection strategies as well. In this study, we wished to field-test the prevalence of SD in a clinical sample of adolescent/young adult help-seekers at putative risk for psychosis attending standard community mental health facilities in Italy. Participants (n = 47), aged between 14 and 25, underwent extensive psychopathological evaluations with current semi-structured tools to assess Clinical High Risk (CHR) state (ie, Structured Interview for Prodromal Syndromes/Scale of Prodromal Symptoms [SIPS/SOPS], Schizophrenia Proneness Instrument-Adult/Child and Youth [SPI-A/CY]). SD aggregated in CHR subjects as compared to the non-CHR and revealed substantial association with sub-psychotic symptoms (SIPS), subjective experience of cognitive and cognitive-perceptual vulnerability (basic symptoms) and functional level (Global Assessment of functioning). Moreover, a combination of the 2 approaches (ie, CHR plus SD) enabled further "closing-in" on a subgroup of CHR with lower global functioning. The results confirm SD's relevance for the early profiling of youths at potential high risk for psychosis.

Comparison of suture-based vascular closure devices in transfemoral transcatheter aortic valve implantation.

AIMS: The aim of this study was to compare outcomes with the use of two haemostasis strategies after transfemoral transcatheter aortic valve implantation (TAVI) - one Prostar® vs. two ProGlide® devices (Abbott Vascular Inc., Santa Clara, CA, USA). METHODS AND RESULTS: This was a retrospective study enrolling consecutive patients undergoing fully percutaneous transfemoral TAVI in our centre (Ferrarotto Hospital, Catania, Italy) from January 2012 to October 2014. All patients were dichotomised according to the vascular closure device (VCD) used for common femoral artery haemostasis (Prostar vs. ProGlide). All outcomes were defined according to VARC-2 criteria. The study population encompassed a total of 278 patients. Of these, 153 (55.1%) underwent TAVI using the Prostar, and 125 (44.9%) using two ProGlide devices. Vascular complications occurred in 48 patients (17.3%), being more frequent in the ProGlide group (11.8% vs. 24.0%, p=0.007). Patients who had TAVI using the ProGlide were also more likely to have a higher rate of percutaneous closure device failure (4.6% vs. 12.8%, p=0.013). Percutaneous peripheral intervention was performed in 13.7% and 28.0% of Prostar and ProGlide cases, respectively (p=0.003). CONCLUSIONS: Patients undergoing transfemoral TAVI had significantly lower rates of vascular complications and percutaneous closure device failures when the Prostar was used compared with two ProGlide devices.

Acute Kidney Injury With the RenalGuard System in Patients Undergoing Transcatheter Aortic Valve Replacement: The PROTECT-TAVI Trial (PROphylactic effecT of furosEmide-induCed diuresis with matched isotonic intravenous hydraTion in Transcatheter Aortic Valve Implantation).

OBJECTIVES: The purpose of this study was to investigate the effect of the RenalGuard System (PLC Medical Systems, Milford, Massachusetts) on prevention of acute kidney injury (AKI) in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: TAVR is associated with varying degrees of post-procedural AKI. The RenalGuard System is a dedicated device designed for contrast-induced AKI prevention. Whether this device is also effective in patients with severe aortic stenosis undergoing TAVR is unexplored. METHODS: The present is an investigator-driven, single-center, prospective, open-label, registry-based randomized study that used the TAVR institutional registry of the Ferrarotto Hospital in Catania, Italy, as the platform for randomization, data collection, and follow-up assessment. A total of 112 consecutive patients undergoing TAVR were randomly assigned to hydration with normal saline solution controlled by the RenalGuard system and furosemide (RenalGuard group) or normal saline solution (control group). The primary endpoint was the incidence of Valve Academic Research Consortium-defined AKI in the first 72 h after the procedure. RESULTS: The AKI rate was lower in the RenalGuard group than in the control group (n = 3 [5.4%] vs. n =14 [25.0%], respectively, p = 0.014). The majority of patients (5.4% vs. 23.2%) developed a mild AKI (stage 1); severe damage (stage 3) occurred only in 1 patient in the control group (0.0% vs. 1.8%). No case of in-hospital renal failure requiring dialysis was reported. No significant differences in terms of mortality, cerebrovascular events, bleeding, and hospitalization for heart failure were noted in both groups at 30 days. CONCLUSIONS: Furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVR.

5-Year Outcomes After Transcatheter Aortic Valve Implantation With CoreValve Prosthesis.

OBJECTIVES: The purpose of this analysis was to assess 5-year outcomes of transcatheter aortic valve implantation (TAVI) using the current technology of the self-expanding CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota). BACKGROUND: There is a paucity of evidence on long-term durability of currently available transcatheter heart valves. METHODS: Starting in June 2007, all consecutive patients with severe aortic stenosis undergoing TAVI with the third-generation 18-F CoreValve device in 8 Italian centers were prospectively included in the ClinicalService Project. For the purposes of this study, we included only consecutive patients with 5-year follow-up data available (n = 353) treated from June 2007 to August 2009. All outcomes were reported according to VARC (Valve Academic Research Consortium)-1 criteria. RESULTS: All-cause mortality rates at 1, 2, 3, 4, and 5 years were 21%, 29%, 38%, 48%, and 55.0%, respectively. Cardiovascular mortality rates at 1, 2, 3, 4, and 5 years were 10%, 14%, 19%, 23%, and 28.0%, respectively. The overall neurological event rate at 5 years was 7.5%, of which more than two-thirds occurred early after the procedure. During follow-up, there were 241 rehospitalizations for cardiovascular reasons in 164 (46%) patients. Among all rehospitalizations, acute heart failure was the most frequently reported (42.7%), followed by requirement of permanent pacemaker implantation (17.4%). On echocardiography, mean transaortic gradients decreased from 55.6 ± 16.8 mm Hg (pre-TAVI) to 12.8 ± 10.9 mm Hg (5-year post-TAVI) (p < 0.001). Late prosthesis failure occurred in 5 cases (1.4%); among these, redo TAVI was successfully carried out in 2 patients (0.6%) presenting with symptomatic prosthesis restenosis. The remaining 3 cases of prosthesis failure did not undergo further invasive interventions. Ten patients (2.8%) showed late mild stenosis with a mean transaortic gradient ranging from 20 to 40 mm Hg. No other cases of structural or nonstructural valvular deterioration were observed. Valve thrombosis or late valve embolization were not reported. CONCLUSIONS: TAVI with the currently adopted CoreValve generation was associated with sustained clinical outcomes up to 5-year follow-up, with a low rate (1.4%) of significant prosthetic valve degeneration. The procedure appears to be an adequate and lasting resolution of aortic stenosis in selected high-risk patients.