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Aims: In cardiac device implantation, having both surgical skills and ability to manipulate catheter/lead/wire is crucial. Few cardiologists, however, receive formal surgical training prior to implanting. Skills are mostly acquired directly on-the-job and surgical technique varies across institutions; suboptimal approaches may increase complications. We investigated how novel proficiency-based progression (PBP) simulation training impacts the surgical quality of implantations, compared to traditional simulation (SIM) training., Methods and Results: In this international prospective study, novice implanters were randomized (blinded) 1:1 to participate in a simulation-based procedure training curriculum, with proficiency demonstration requirements for advancing (PBP approach) or without (SIM). Ultimately, trainees performed the surgical tasks of an implant on a porcine tissue that was video-recorded and then scored by two independent assessors (blinded to group), using previously validated performance metrics. Primary outcomes were the number of procedural Steps Completed, Critical Errors, Errors (non-critical), and All Errors Combined. Thirty novice implanters from 10 countries participated. Baseline experiences were similar between groups. Compared to SIM-trained, the PBP-trained group completed on average 11% more procedural Steps (P < 0.001) and made 61.2% fewer Critical Errors (P < 0.001), 57.1% fewer Errors (P = 0.140), and 60.7% fewer All Errors Combined (P = 0.001); 11/15 (73%) PBP trainees demonstrated the predefined target performance level vs. 3/15 SIM trainees (20%) in the video-recorded performance., Conclusion: Proficiency-based progression training produces superior objectively assessed novice operators' surgical performance in device implantation compared with traditional (simulation) training. Systematic PBP incorporation into formal academic surgical skills training is recommended before in vivo device practice. Future studies will quantify PBP training's effect on surgery-related device complications., Competing Interests: Conflict of interest: J.M. conducted the present research project as part of his PhD studies at KU Leuven, Belgium. J.M. is also an employee of Medtronic. M.S. reports personal fees (honoraria for educational activity) from Medtronic during the conduct of the project and personal fees from Biotronik outside the submitted work; A.P. reports personal fees (honoraria for educational activity) from Medtronic during the conduct of the project; L.M. reports grants and personal fees (support for Fellowship programme, research grants, consulting honoraria) from Medtronic, Abbott, and Boston Scientific during the conduct of the project; A.R. reports teaching honoraria from Medtronic outside the submitted work; H.R. reports personal fees (honoraria for educational activity) from Medtronic during the conduct of the project and outside the submitted work; C.G. reports research funding from Abbott, Biotronik, and Medtronic, and speaker/consultancy fees from Medtronic, Biotronik, and Abbott outside the submitted work; A.G.G. reports personal fees (consulting) from Medtronic during the conduct of the project; T.V. reports personal fees (lectures honoraria) from Medtronic outside the submitted work., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: There are conflicting data on the effect of cardiac resynchronization therapy with a defibrillator (CRT-D) on the risk of life-threatening ventricular tachyarrhythmia in heart failure patients., Objectives: The authors aimed to assess whether QRS morphology is associated with risk of ventricular arrhythmias in CRT recipients., Methods: The study population comprised 2,862 patients implanted with implantable cardioverter defibrillator (ICD)/CRT-D for primary prevention who were enrolled in 5 landmark primary prevention ICD trials (MADIT-II [Multicenter Automated Defibrillator Implantation Trial], MADIT-CRT [Multicenter Automated Defibrillator Implantation Trial-Cardiac Resynchronization Therapy], MADIT-RIT [Multicenter Automated Defibrillator Implantation Trial-Reduction in Inappropriate Therapy], MADIT-RISK [Multicenter Automated Defibrillator Implantation Trial-RISK], and RAID [Ranolazine in High-Risk Patients With Implanted Cardioverter Defibrillators]). Patients with QRS duration ≥130 ms were divided into 2 groups: those implanted with an ICD only vs CRT-D. The primary endpoint was fast ventricular tachycardia (VT)/ventricular fibrillation (VF) (defined as VT ≥200 beats/min or VF), accounting for the competing risk of death. Secondary endpoints included appropriate shocks, any sustained VT or VF, and the burden of fast VT/VF, assessed in a recurrent event analysis., Results: Among patients with left bundle branch block (n = 1,792), those with CRT-D (n = 1,112) experienced a significant 44% (P < 0.001) reduction in the risk of fast VT/VF compared with ICD-only patients (n = 680), a significantly lower burden of fast VT/VF (HR: 0.55; P = 0.001), with a reduced burden of appropriate shocks (HR: 0.44; P < 0.001). In contrast, among patients with non-left bundle branch block (NLBBB) (N = 1,070), CRT-D was not associated with reduction in fast VT/VF (HR: 1.33; P = 0.195). Furthermore, NLBBB patients with CRT-D experienced a statistically significant increase in the burden of fast VT/VF events compared with ICD-only patients (HR: 1.90; P = 0.013)., Conclusions: Our data suggest a potential proarrhythmic effect of CRT among patients with NLBBB. These data should be considered in patient selection for treatment with CRT., Competing Interests: Funding Support and Author Disclosures The MADIT studies were funded by an unrestricted research grant from Boston Scientific to the University of Rochester Medical Center, Rochester, New York. All authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: We investigated the implementation of new guidelines in ST-segment elevation myocardial infarction (STEMI) patients in a large real-world patient population in the metropolitan area of Berlin (Germany) over a 20-year period., Methods: From January 2000 to December 2019, a total of 25 792 patients were admitted with STEMI to one of the 34 member hospitals of the Berlin-Brandenburg Myocardial Infarction Registry (B2HIR) and were stratified for sex and age < 75 and ≥ 75 years., Results: The median age of women was 72 years (IQR 61-81) compared to 61 years in men (IQR 51-71). PCI treatment as a standard of care was implemented in men earlier than in women across all age groups. It took two years from the 2017 class IA ESC STEMI guideline recommendation to prefer the radial access route rather than femoral until > 60% of patients were treated accordingly. In 2019, less than 60% of elderly women were treated via a radial access. While the majority of patients < 75 years already received ticagrelor or prasugrel as antiplatelet agent in the year of the class IA ESC STEMI guideline recommendation in 2012, men ≥ 75 years lagged two years and women ≥ 75 three years behind. Amongst the elderly, in-hospital mortality was 22.6% (737) for women and 17.3% (523) for men (p < 0.001). In patients < 75 years fatal outcome was less likely with 7.2% (305) in women and 5.8% (833) in men (p < 0.001). After adjustment for confounding variables, female sex was an independent predictor of in-hospital mortality in patients ≥ 75 years (OR 1.37, 95% CI 1.12-1.68, p = 0.002), but not in patients < 75 years (p = 0.076)., Conclusion: In-hospital mortality differs considerably by age and sex and remains highest in elderly patients and in particular in elderly females. In these patient groups, guideline recommended therapies were implemented with a significant delay., (© 2023. The Author(s).)

We analyze the introduction of prescription-free access to morning-after pills-emergency contraceptives that aim to prevent unintended pregnancy and subsequent abortion after unprotected sexual intercourse. Exploiting a staggered difference-in-differences setting for Europe combined with randomization inference, we find sharp increases in sales and manufacturers' revenues of more than 90%. However, whilst not reducing abortions significantly, the policy triggers an unexpected increase in fertility of 4%, particularly among women aged 25-34. We elaborate on mechanisms by looking at within-country evidence from several EU countries, which suggests that fertility is driven by decreasing use of birth control pills in response to easier access to morning-after pills., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Importance: In cardiac device implant training, there is no common system to objectively assess trainees' ability to perform tasks at predetermined performance levels before in vivo practice; therefore, patients are potentially exposed to risks related to operators' early learning curve., Objective: To assess the effect on implant performance quality of novel metrics-based simulation training to proficiency (proficiency-based progression [PBP]) vs traditional simulation-based training (SBT)., Design, Setting, and Participants: In this prospective randomized trial, conducted between March 8, 2022 and November 24, 2022, novice implanters were randomized (blinded) 1:1 to participate in an SBT curriculum (procedural knowledge e-learning and in-person simulation training) at an international skills training center, with proficiency demonstration requirements at each training stage for advancing (PBP approach) or without the requirements. Ultimately, trainees performed a cardiac resynchronization therapy (CRT) implant using virtual reality simulation. The procedure was video-recorded and subsequently scored using previously validated metrics by 2 independent assessors blinded to group. Physicians who had already implanted more than 20 pacemakers or defibrillators and fewer than 200 CRT systems as the first operator were eligible. Thirty-two implanters from 10 countries voluntarily enrolled in the training program and were randomized; 30 (15 per group) started and completed training. Data analysis was performed from November 27 to December 22, 2022., Intervention: Training with PBP vs SBT., Main Outcome and Measures: The primary outcome comprised 4 objectively assessed performance metrics derived from the video-recordings: number of procedural steps completed, errors, critical errors, and all errors combined., Results: Baseline experience of the 30 participants (19 [63%] male; mean [SD] number of years in implant practice, 2.0 [1.8]; median [IQR] number of implanted pacemakers or defibrillators, 47.5 [30.0-115.0]; median [IQR] number of implanted CRT systems, 3.0 [1.25-10.0]) was similar between study groups. Compared with the SBT group, the PBP group completed 27% more procedural steps (median [IQR], 31 [30-32] vs 24 [22-27]; P < .001) and made 73% fewer errors (median [IQR], 2 [1-3] vs 7 [5-8]; P < .001), 84% fewer critical errors (median [IQR], 1 [0-1] vs 3 [3-5]; P < .001), and 77% fewer all errors combined (errors plus critical errors) (median [IQR], 3 [1-3] vs 11 [8-12]; P < .001); 14 of the 15 PBP trainees (93%) demonstrated the predefined target performance level vs 0 of the 15 SBT trainees., Conclusions and Relevance: In this randomized trial, the PBP approach to novice implanter training generated superior objectively assessed performance vs SBT. If implemented broadly and systematically, PBP training may ensure safe and effective performance standards before trainees proceed to (supervised) in vivo practice. Future studies are needed to verify implications on procedure-related patient complications., Trial Registration: ClinicalTrials.gov Identifier: NCT05952908.

Background: Maintaining mobility in old age is crucial for healthy ageing including delaying the onset and progress of frailty. However, the extent of an individuals´ mobility relies largely on their personal, social, and environmental resources as outlined in the Life-Space Constriction Model. Recent studies mainly focus on facilitating habitual out-of-home mobility by fostering one type of resources only. The MOBILE trial aims at testing whether tablet-assisted motivational counselling enhances the mobility of community-dwelling older adults by addressing personal, social, and environmental resources., Methods: In the MOBILE randomized controlled trial, we plan to enrol 254 community-dwelling older adults aged 75 and older from Havelland, a rural area in Germany. The intervention group will receive a tablet-assisted motivational counselling at the participant´s home and two follow-up telephone sessions. Main focus of the counselling sessions lays on setting and adapting individual mobility goals and applying action planning and habit formation strategies by incorporating the personal social network and regional opportunities for engaging in mobility related activities. The control group will receive postal general health information. The primary mobility outcome is time out-of-home assessed by GPS (GPS.Rec2.0-App) at three points in time (baseline, after one month, and after three months for seven consecutive days each). Secondary outcomes are the size of the GPS-derived life-space convex hull, self-reported life-space mobility (LSA-D), physical activity (IPAQ), depressive symptoms (GDS), frailty phenotype, and health status (SF-12)., Discussion: The MOBILE trial will test the effect of a motivational counselling intervention on out-of-home mobility in community-dwelling older adults. Novel aspects of the MOBILE trial include the preventive multi-level intervention approach in combination with easy-to-use technology. The ecological approach ensures low-threshold implementation, which increases the benefit for the people in the region., Trial Registration: The MOBILE trial is prospectively registered at DRKS (Deutsches Register Klinischer Studien, German Registry of Clinical Trials) DRKS00025230 . Registered 5 May 2021., (© 2022. The Author(s).)

The non-physician employees in telemedicine centers (TMC) play a decisive role in the care and treatment of patients with heart failure. For this reason, a holistic profile consisting of professional and methodological as well as social and personal competences is necessary, which should be built up or promoted in corresponding training concepts. This position paper underlines the urgency of appropriate and standardized further training of non-physician employees for quality assurance in TMCs and summarizes the requirements for the additional qualification of a telemedical assistant across the board., (© 2021. Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)