Exploring the structure of fearlessness using self-report measures.

OBJECTIVE: The present study examined the hierarchical structure of self-reported fearlessness and compared this structure to external criterion measures. BACKGROUND: Fearlessness is often discussed in relation to clinical and personality research. However, there is a paucity of research focusing on its empirical structure, in particular with self-report measures. METHOD: Using a preregistered analytical approach, we employed Goldberg's 2006 "bass-ackward" factor analysis on self-reported trait fear and fearlessness items to uncover the hierarchical structure of the construct. The final sample consisted of 619 participants and 562 informants. RESULTS: By assessing fit statistics and interpretability of the factors, we found a six-factor model fit the data best. The six-factor solution emerged as comprehensive and included components labeled Assertiveness, Low Anxiety, Sociability, Recklessness, Openness to Action, and Adventurousness. Criterion variables measuring boldness, fear, anxiety, psychopathy, basic personality traits, and impulsivity, were correlated with the factor scores at each factor level of the model. Conclusions The findings from this study elucidate how trait fearlessness unfolds at varying levels and how these factors relate to and diverge from various outcomes.

Development of a measure of aggressive behavior expectancies in adults: The Aggression Expectancy Questionnaire.

According to sociocognitive theories, aggression is learned and elicited through a series of cognitive processes, such as expectancies, or the various consequences that an individual considers more or less likely following aggressive behavior. The current manuscript describes a measurement development project that ultimately yielded a 16-item measure of positive and negative aggression expectancies suitable for use in adult populations. Across two content generation surveys, two preliminary item refinement studies, and three full studies, we took an iterative approach and administered large item pools to several samples and refined item content through a combination of empirical (i.e., factor loadings, model fit) and conceptual (i.e., content breadth, non-redundancy) considerations. The Aggression Expectancy Questionnaire displays a four-factor structure, as well as evidence of convergent and divergent validity with self-reported aggression and relevant basic (e.g., antagonism, anger) and complex (e.g., psychopathy) personality variables. It is posited that this type of cognitive mechanism may serve as an intermediary link between distal characterological predictors of aggression and its proximal manifestation, which is in line with several prominent theories of personality and may ultimately hold clinical utility by providing a framework for aggression interventions.

Subcutaneous implantable cardioverter-defibrillators: long-term results of the EFFORTLESS study.

AIMS: To report 5-year outcomes of EFFORTLESS registry patients with early generation subcutaneous implantable cardioverter-defibrillator (S-ICD) devices. METHODS AND RESULTS: Kaplan-Meier, trend and multivariable analyses were performed for mortality and late (years 2-5) complications, appropriate shock (AS) and inappropriate shock (IAS) rates. Nine hundred and eighty-four of 994 enrolled patients with diverse diagnoses (28% female, 48 ± 17 years, body mass index 27 ± 6 kg/m2, ejection fraction 43 ± 18%) underwent S-ICD implantation. Median follow-up was 5.1 years (interquartile range 4.7-5.5 years). All-cause mortality was 9.3% (95% confidence interval 7.2-11.3%) at 5 years; 703 patients remained in follow-up on study completion, 171 withdrew including 87 (8.8%) with device explanted, and 65 (6.6%) lost to follow-up. Of the explants, only 20 (2.0%) patients needed a transvenous device for pacing indications. First and final shock efficacy for discrete ventricular arrhythmias was consistent at 90% and 98%, respectively, with storm episode final shock efficacy at 95.2%. Time to therapy remained unaltered. Overall 1- and 5-year complication rates were 8.9% and 15.2%, respectively. Early complications did not predict later complications. There were no structural lead failures. Inappropriate shock rates at 1 and 5 years were 8.7% and 16.9%, respectively. Self-terminating inappropriately sensed episodes predicted late IAS. Predictors of late AS included self-terminating appropriately sensed episodes and earlier AS. CONCLUSION: In this diverse S-ICD registry population, spontaneous shock efficacy was consistently high over 5 years. Very few patients underwent S-ICD replacement with a transvenous device for pacing indications. Treated and self-terminating arrhythmic episodes predict future shock events, which should encourage more personalized device optimization.

Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial.

BACKGROUND: The subcutaneous (S) implantable cardioverter-defibrillator (ICD) is safe and effective for sudden cardiac death prevention. However, patients in previous S-ICD studies had fewer comorbidities, had less left ventricular dysfunction, and received more inappropriate shocks (IAS) than in typical transvenous ICD trials. The UNTOUCHED trial (Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction) was designed to evaluate the IAS rate in a more typical, contemporary ICD patient population implanted with the S-ICD using standardized programming and enhanced discrimination algorithms. METHODS: Primary prevention patients with left ventricular ejection fraction ≤35% and no pacing indications were included. Generation 2 or 3 S-ICD devices were implanted and programmed with rate-based therapy delivery for rates ≥250 beats per minute and morphology discrimination for rates ≥200 and <250 beats per minute. Patients were followed for 18 months. The primary end point was the IAS-free rate compared with a 91.6% performance goal, derived from the results for the ICD-only patients in the MADIT-RIT study (Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy). Kaplan-Meier analyses were performed to evaluate event-free rates for IAS, all-cause shock, and complications. Multivariable proportional hazard analysis was performed to determine predictors of end points. RESULTS: S-ICD implant was attempted in 1116 patients, and 1111 patients were included in postimplant follow-up analysis. The cohort had a mean age of 55.8±12.4 years, 25.6% were women, 23.4% were Black, 53.5% had ischemic heart disease, 87.7% had symptomatic heart failure, and the mean left ventricular ejection fraction was 26.4±5.8%. Eighteen-month freedom from IAS was 95.9% (lower confidence limit, 94.8%). Predictors of reduced incidence of IAS were implanting the most recent generation of device, using the 3-incision technique, no history of atrial fibrillation, and ischemic cause. The 18-month all-cause shock-free rate was 90.6% (lower confidence limit, 89.0%), meeting the prespecified performance goal of 85.8%. Conversion success rate for appropriate, discrete episodes was 98.4%. Complication-free rate at 18 months was 92.7%. CONCLUSIONS: This study demonstrates high efficacy and safety with contemporary S-ICD devices and programming despite the relatively high incidence of comorbidities in comparison with earlier S-ICD trials. The inappropriate shock rate (3.1% at 1 year) is the lowest reported for the S-ICD and lower than many transvenous ICD studies using contemporary programming to reduce IAS. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02433379.

Structural brain differences do not mediate the relations between sex and personality or psychopathology.

INTRODUCTION: Males and females tend to exhibit small but reliable differences in personality traits and indices of psychopathology that are relatively stable over time and across cultures. Previous work suggests that sex differences in brain structure account for differences in domains of cognition. METHODS: We used data from the Human Connectome Project (N = 1098) to test whether sex differences in brain morphometry account for observed differences in the personality traits neuroticism and agreeableness, as well as symptoms of internalizing and externalizing psychopathology. We operationalized brain morphometry in three ways: omnibus measures (e.g., total gray matter volume), Glasser regions defined through a multi-modal parcellation approach, and Desikan regions defined by structural features of the brain. RESULTS: Most expected sex differences in personality, psychopathology, and brain morphometry were observed, but the statistical mediation analyses were null: sex differences in brain morphometry did not account for sex differences in personality or psychopathology. CONCLUSIONS: Men and women tend to exhibit meaningful differences in personality and psychopathology, as well as in omnibus morphometry and regional morphometric differences as defined by the Glasser and Desikan atlases, but these morphometric differences appear unrelated to the psychological differences.

An empirically based power primer for laboratory aggression research.

Recent reviews suggest that, like much of the psychological literature, research studies using laboratory aggression paradigms tend to be underpowered to reliably locate commonly observed effect sizes (e.g., r = ~.10-.20, Cohen's d = ~0.20-0.40). In an effort to counter this trend, we provide a "power primer" that laboratory aggression researchers can use as a resource when planning studies using this methodology. Using simulation-based power analyses and effect size estimates derived from recent literature reviews, we provide sample size recommendations based on type of research question (e.g., main effect vs. two-way vs. three-way interactions) and correlations among predictors. Results highlight the large number of participants that must be recruited to reach acceptable (~80%) power, especially for tests of interactions where the recommended sample sizes far exceed those typically employed in this literature. These discrepancies are so substantial that we urge laboratory aggression researchers to consider a moratorium on tests of three-way interactions. Although our results use estimates from the laboratory aggression literature, we believe they are generalizable to other lines of research using behavioral tasks, as well as psychological science more broadly. We close by offering a series of best practice recommendations and reiterating long-standing calls for attention to statistical power as a basic element of study planning.

Outcomes of two versus three incision techniques: Results from the subcutaneous ICD post-approval study.

BACKGROUND: Traditionally, implantation of the subcutaneous implantable cardioverter defibrillator (S-ICD) requires incisions near the lateral chest wall, the xyphoid, and the superior sternal region (three-incision technique [3IT]). A two-incision technique (2IT) avoids the superior incision and has been shown to be a viable alternative in small studies with limited follow-up. OBJECTIVES: To report on the long-term safety and efficacy of the 2IT compared to the 3IT procedure in a large patient cohort. METHODS: Patients enrolled in the S-ICD post approval study (PAS) were stratified by procedural technique (2IT vs. 3IT). Baseline demographics, comorbidities and procedural outcomes were collected. Complications and S-ICD effectiveness in treating ventricular arrhythmias through an average 3-year follow-up period were compared. RESULTS: Of 1637 patients enrolled in the S-ICD PAS, 854 pts (52.2%) were implanted using the 2IT and 782 were implanted using the 3IT (47.8%). The 2IT became more prevalent over time, increasing from 40% to 69% of implants (Q1-Q4). Mean procedure time was shorter with 2IT (69.0 vs. 86.3 min, p < .0001). No other differences in outcomes were observed between the two groups, including rates of infection, electrode migration, inappropriate shocks and first shock efficacy for treating ventricular arrhythmias. CONCLUSION: In this large cohort of patients implanted with an S-ICD and followed for 3 years the 2IT was as safe and effective as the 3IT while significantly reducing procedure time.

The quandary of covarying: A brief review and empirical examination of covariate use in structural neuroimaging studies on psychological variables.

Although covarying for potential confounds or nuisance variables is common in psychological research, relatively little is known about how the inclusion of covariates may influence the relations between psychological variables and indices of brain structure. In Part 1 of the current study, we conducted a descriptive review of relevant articles from the past two years of NeuroImage in order to identify the most commonly used covariates in work of this nature. Age, sex, and intracranial volume were found to be the most commonly used covariates, although the number of covariates used ranged from 0 to 14, with 37 different covariate sets across the 68 models tested. In Part 2, we used data from the Human Connectome Project to investigate the degree to which the addition of common covariates altered the relations between individual difference variables (i.e., personality traits, psychopathology, cognitive tasks) and regional gray matter volume (GMV), as well as the statistical significance of values associated with these effect sizes. Using traditional and random sampling approaches, our results varied widely, such that some covariate sets influenced the relations between the individual difference variables and GMV very little, while the addition of other covariate sets resulted in a substantially different pattern of results compared to models with no covariates. In sum, these results suggest that the use of covariates should be critically examined and discussed as part of the conversation on replicability in structural neuroimaging. We conclude by recommending that researchers pre-register their analytic strategy and present information on how relations differ based on the inclusion of covariates.

Quality of life, depression, and anxiety in patients with a subcutaneous versus transvenous defibrillator system.

BACKGROUND: Use of the subcutaneous implantable defibrillator (S-ICD) has increased because the device received US Food and Drug Administration approval in 2012, but we still know little about whether the quality of life (QoL) of patients with an S-ICD versus a transvenous ICD (TV-ICD) is comparable. We compared S-ICD patients with TV-ICD patients on QoL, depression, and anxiety up to 12 months' follow-up. METHODS: A matched cohort of S-ICD (N = 167) and TV-ICD patients (N = 167) completed measures on QoL, depression, anxiety, and personality at baseline, 3, 6, and 12 months post implant. Data were analyzed using multivariable modeling with repeated measures. RESULTS: In adjusted analyses, we found no statistically significant differences between cohorts on physical and mental QoL and depression (all Ps > .05), while S-ICD patients reported lower anxiety than TV-ICD patients (P = 0.0007). Both cohorts experienced improvements in physical and mental QoL and symptoms of depression and anxiety over time (all Ps < .001), primarily between implant and 3 months. These improvements were similar for both cohorts with respect to physical and mental QoL and anxiety (Ps > .05), while S-ICD patients experienced greater reductions in depressive symptoms (P = .0317). CONCLUSION: The QoL and depression levels were similar in patients with an S-ICD and a TV-ICD up to 12 months' follow-up, while S-ICD patients reported lower anxiety levels and a greater reduction in depression over time as compared to TV-ICD patients. This knowledge may be important for patients and clinicians, if the indication for implantation allows both the S-ICD and the TV-ICD, making a choice possible.

Using Item Response Theory to Develop a 60-Item Representation of the NEO PI-R Using the International Personality Item Pool: Development of the IPIP-NEO-60.

Given advantages of freely available and modifiable measures, an increase in the use of measures developed from the International Personality Item Pool (IPIP), including the 300-item representation of the Revised NEO Personality Inventory (NEO PI-R; Costa & McCrae, 1992a ) has occurred. The focus of this study was to use item response theory to develop a 60-item, IPIP-based measure of the Five-Factor Model (FFM) that provides equal representation of the FFM facets and to test the reliability and convergent and criterion validity of this measure compared to the NEO Five Factor Inventory (NEO-FFI). In an undergraduate sample (n = 359), scores from the NEO-FFI and IPIP-NEO-60 demonstrated good reliability and convergent validity with the NEO PI-R and IPIP-NEO-300. Additionally, across criterion variables in the undergraduate sample as well as a community-based sample (n = 757), the NEO-FFI and IPIP-NEO-60 demonstrated similar nomological networks across a wide range of external variables (rICC = .96). Finally, as expected, in an MTurk sample the IPIP-NEO-60 demonstrated advantages over the Big Five Inventory-2 (Soto & John, 2017 ; n = 342) with regard to the Agreeableness domain content. The results suggest strong reliability and validity of the IPIP-NEO-60 scores.

Protein Self-Assemblies That Can Generate, Hold, and Discharge Electric Potential in Response to Changes in Relative Humidity.

Generation of electric potential upon external stimulus has attracted much attention for the development of highly functional sensors and devices. Herein, we report large-displacement, fast actuation in the self-assembled engineered repeat protein Consensus Tetratricopeptide Repeat protein (CTPR18) materials. The ionic nature of the CTPR18 protein coupled to the long-range alignment upon self-assembly results in the measured conductivity of 7.1 × 10-2 S cm-1, one of the highest reported for protein materials. The change of through-thickness morphological gradient in the self-assembled materials provides the means to select between faster, highly water-sensitive actuation or vastly increased mechanical strength. Tuning of the mode of motion, e.g., bending, twisting, and folding, is achieved by changing the morphological director. We further show that the highly ionic character of CTPR18 gives rise to piezo-like behavior in these materials, exemplified by low-voltage, ionically driven actuation and mechanically driven generation/discharge of voltage. This work contributes to our understanding of the emergence of stimuli-responsiveness in biopolymer assemblies.

A Comparison of the Nomological Networks Associated With Forced-Choice and Likert Formats of the Narcissistic Personality Inventory.

The Narcissistic Personality Inventory (NPI) is one of the most popular measures of narcissism. However, its use of a forced-choice response set might negatively affect some of its psychometric properties. The purpose of this research was to compare a Likert version of the NPI, in which only the narcissistic response of each pair was given, to the original NPI, in 3 samples of participants (N = 1,109). To this end, we compared the nomological networks of the forced-choice and Likert formats of the NPI in relation to alternative measures of narcissism, narcissistic personality disorder, entitlement, self-esteem, general personality traits (reported by self and informants), interpersonal styles, and general pathological traits included in the DSM-5. The Likert format NPI-total and subscales-manifested similar construct validity to the original forced-choice format across all criteria with only minor differences that seem to be due mainly to the increased reliability and variability found in the Likert NPI Entitlement/Exploitativeness subscale. These results provide evidence that a version of the NPI that employs a Likert format can justifiably be used in place of the original.

The Design of the Understanding Outcomes with the S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED).

BACKGROUND: The UNTOUCHED study will assess the safety and efficacy of the subcutaneous implantable cardioverter defibrillator (S-ICD) in the most common cohort of patients receiving ICDs. The primary goal is to evaluate the inappropriate shock (IAS)-free rate in primary prevention patients with a reduced ejection fraction (EF) and compare with a historical control of transvenous ICD patients with similar programming. METHODS AND RESULTS: The UNTOUCHED study is a global, multicenter, prospective, nonrandomized study of patients undergoing de novo S-ICD implantation for primary prevention of sudden cardiac death with a left ventricular EF ≤35%. The primary end point of this trial is freedom from IAS at 18 months. The lower 95% confidence bound of the observed incidence will be compared to a performance goal of 91.6%, which was derived from the IAS rate in MADIT-RIT. The secondary end points are all-cause shock-free rate at 18 months, and system- and procedure-related complication-free rate at 1 month and 6 months. Enrollment of a minimum of 1,100 subjects from up to 200 centers worldwide is planned based on power calculations of the primary and principal secondary end points. CONCLUSIONS: This trial will provide important data regarding the rates of inappropriate and appropriate shock therapy in real-world use of the S-ICD in the most common group of patients receiving ICDs.

Psychopathy and Machiavellianism: A Distinction Without a Difference?

A robust literature has emerged on the Dark Triad (DT) of personality-Machiavellianism (MACH), psychopathy, and narcissism. Questions remain as to whether MACH and psychopathy are distinguishable and whether MACH's empirical and theoretical networks are consistent. In Study 1 (N = 393; MTurk research participants), factor analyses were used to compare two-factor (MACH and psychopathy combined + narcissism) and three-factor models, with both fitting the data equally well. In Studies 1 and 2 (N = 341; undergraduate research participants), DT scores were examined in relation to a variety of external criteria, including self- and informant ratings of personality, adverse developmental experiences, and psychopathological symptoms/behaviors. In both studies, MACH and psychopathy manifested nearly identical empirical profiles and both were significantly related to disinhibitory traits thought to be antithetical to MACH. In Study 3 (N = 36; expert raters), expert ratings of the Five-Factor Model traits prototypical of MACH were collected and compared with empirically derived profiles. Measures of MACH yielded profiles that were inconsistent with the prototypical expert-rated profile due to their positive relations with a broad spectrum of impulsivity-related traits. Ultimately, measures of psychopathy and MACH appear to be measuring the same construct, and MACH assessments fail to capture the construct as articulated in theoretical descriptions.

Gender Bias in the Measurement of Workaholism.

Past research suggests gender differences in workaholism might be due to differences in how men and women respond to the item content in workaholism measures. Using item response theory differential item functioning, we show women are less likely to report some workaholism items, leading to contamination. Specifically, women are less likely to report spending more time at work than other activities, and staying at work longer than others. We speculate that societal norms and practical restrictions on women's time results in lower endorsement rates for these items compared to men, and thus underestimates their workaholism. Results contradict past findings that men and women are similar in regard to workaholism and suggest women are in fact higher in workaholism than men. Limitations and future directions are discussed.

Implantable Cardioverter Defibrillator Programming Characteristics, Shocked Rhythms, and Survival Among Patients Under Thirty Years of Age.

INTRODUCTION: Indications for implantable cardioverter defibrillators (ICDs) in young patients have expanded and differ from those in older adults. We sought to provide descriptive characteristics and data regarding ICD therapy and outcomes among younger and older ICD recipients. METHODS AND RESULTS: Demographics, device type and programming, remotely transmitted data, shock events, and survival were compared among younger (≤30 years) and older (>30 years) cohorts with ICDs from a single manufacturer followed on a remote network. The younger cohort included 904 patients (1.6% of all implants). This group had more females (46% vs. 25%; P < 0.01), single-coil leads (21% vs. 4%; P < 0.01), and single-chamber devices (46% vs. 34%; P < 0.01). Shock incidence was higher (40% younger vs. 32% older at 4 years; P < 0.01) and survival was better over comparable follow-up (88% vs. 72%; P < 0.01). Remote monitoring was associated with improved survival in both groups (93% vs. 86% ≤ 30 years, P < 0.01; 73% vs. 66% > 30 years, P < 0.01). Shock for polymorphic ventricular tachycardia/fibrillation (VT/VF) was more frequent in younger patients (12% vs. 5%; P < 0.01); 39% of all shocks were inappropriate. A 10-fold increased risk of mortality was seen among young patients with shocks for atrial fibrillation/flutter (AF/AFL). CONCLUSIONS: Differences in survival, shock incidence, and prognostic significance of VT/VF and AF/AFL exist between younger and older ICD recipients. These suggest distinct differences in myocardial substrates and diseases that ultimately impact ICD management.

The Downsides of Extreme Conscientiousness for Psychological Well-being: The Role of Obsessive Compulsive Tendencies.

Although conscientiousness exhibits positive relations with psychological well-being, theoretical and empirical work suggests individuals can be too conscientious, resulting in obsessive-compulsiveness, and therein less positive individual outcomes. However, the potential for curvilinearity between conscientiousness and well-being has been underexplored. We measured 912 subjects on facets of conscientiousness, obsessive-compulsive personality, and well-being variables (life satisfaction, job satisfaction, self-esteem, positive affect, negative affect, work stress). Methods of scoring included traditional sum-scoring, traditional item response theory (IRT), and a relatively new IRT approach. Structural models were estimated to evaluate curvilinearity. Results confirmed the curvilinear relationship between conscientiousness and well-being, and demonstrated that differential facet-level relationships underlie weaker curvilinearity at the general trait level. Consistency was found in the strength of relation between conscientiousness facets with their obsessive-compulsive variants and their contribution to decreased well-being. The most common association was that higher standing on conscientiousness facets was positively related to negative affect. Findings support the idea that extreme standing on facets of conscientiousness more strongly linked to their obsessive-compulsive variants contributed to lower well-being, highlighting the importance of considering alternative functional representations of the relationship between personality and other constructs. Future work should seek to further clarify the link between conscientiousness and negative affect.

Design of Self-Assembling Protein-Polymer Conjugates.

Protein-polymer conjugates are of particular interest for nanobiotechnology applications because of the various and complementary roles that each component may play in composite hybrid-materials. This chapter focuses on the design principles and applications of self-assembling protein-polymer conjugate materials. We address the general design methodology, from both synthetic and genetic perspective, conjugation strategies, protein vs. polymer driven self-assembly and finally, emerging applications for conjugate materials. By marrying proteins and polymers into conjugated bio-hybrid materials, materials scientists, chemists, and biologists alike, have at their fingertips a vast toolkit for material design. These inherently hierarchical structures give rise to useful patterning, mechanical and transport properties that may help realize new, more efficient materials for energy generation, catalysis, nanorobots, etc.

Repeat-proteins films exhibit hierarchical anisotropic mechanical properties.

Complex hierarchical structures provide beneficial structure-property relationships that can be exploited for a variety of applications in engineering and biomedical fields. Here we report on molecular organization and resulting mechanical properties of self-assembled designed repeat-protein films. Wide-angle X-ray diffraction indicates the designed 18-repeat concensus tetratricopeptide repeat protein (CTPR18) orients normal to the casting surface, while small-angle measurements and electron microscopy show a through-plane transversely aligned laminar sheet-like morphology. Self-assembly is driven by the combination of CTPRs head-to-tail stacking and weak dipole-dipole interactions. We highlight the effect that this hierarchical structure has on the material's mechanical properties. We use nanoindentation and dynamic mechanical analysis to test the mechanical properties over multiple length scales, from the molecular level to the bulk. We find that morphology predictably affects the film's mechanics from the nano- to the macroscale, with the axial modulus values ranging from 2 to 5 GPa. The predictable nature of the structure-property relationship of CTPR proteins and their assemblies proves them a promising platform for material engineering.

Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry.

AIMS: The totally subcutaneous implantable-defibrillator (S-ICD) is a new alternative to the conventional transvenous ICD system to minimize intravascular lead complications. There are limited data describing the long-term performance of the S-ICD. This paper presents the first large international patient population collected as part of the EFFORTLESS S-ICD Registry. METHODS AND RESULTS: The EFFORTLESS S-ICD Registry is a non-randomized, standard of care, multicentre Registry designed to collect long-term, system-related, clinical, and patient reported outcome data from S-ICD implanted patients since June 2009. Follow-up data are systematically collected over 60-month post-implant including Quality of Life. The study population of 472 patients of which 241 (51%) were enrolled prospectively has a mean follow-up duration of 558 days (range 13-1342 days, median 498 days), 72% male, mean age of 49 ± 18 years (range 9-88 years), 42% mean left ventricular ejection fraction. Complication-free rates were 97 and 94%, at 30 and 360 days, respectively. Three hundred and seventeen spontaneous episodes were recorded in 85 patients during the follow-up period. Of these episodes, 169 (53%) received therapy, 93 being for Ventricular Tachycardia/Fibrillation (VT/VF). One patient died of recurrent VF and severe bradycardia. Regarding discrete VT/VF episodes, first shock conversion efficacy was 88% with 100% overall successful clinical conversion after a maximum of five shocks. The 360-day inappropriate shock rate was 7% with the vast majority occurring for oversensing (62/73 episodes), primarily of cardiac signals (94% of oversensed episodes). CONCLUSION: The first large cohort of real-world data from an International patient S-ICD population demonstrates appropriate system performance with clinical event rates and inappropriate shock rates comparable with those reported for conventional ICDs. Clinical trial registration URL: http://www.clinicaltrials.gov. Unique identifier NCT01085435.