QRS Morphology and the Risk of Ventricular Tachyarrhythmia in Cardiac Resynchronization Therapy Recipients.

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.

Effect of Metrics-Based Simulation Training to Proficiency on Procedure Quality and Errors Among Novice Cardiac Device Implanters: The IMPROF Randomized Trial.

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.

Implementation of the ESC STEMI guidelines in female and elderly patients over a 20-year period in a large German registry.

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.

Mobility enhancement among older adults 75 + in rural areas: Study protocol of the MOBILE randomized controlled trial.

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.

Optimal CRT Implantation-Where and How To Place the Left-Ventricular Lead?

PURPOSE OF REVIEW: Cardiac resynchronization therapy (CRT) represents a well-established and effective non-pharmaceutical heart failure (HF) treatment in selected patients. Still, a significant number of patients remain CRT non-responders. An optimal placement of the left ventricular (LV) lead appears crucial for the intended hemodynamic and hence clinical improvement. A well-localized target area and tools that help to achieve successful lead implantation seem to be of utmost importance to reach an optimal CRT effect. RECENT FINDINGS: Recent studies suggest previous multimodal imaging (CT/cMRI/ECG torso) to guide intraprocedural LV lead placement. Relevant benefit compared to empirical lead optimization is still a matter of debate. Technical improvements in leads and algorithms (e.g., multipoint pacing (MPP), adaptive algorithms) promise higher procedural success. Recently emerging alternatives for ventricular synchronization such as conduction system pacing (CSP), LV endocardial pacing, or leadless pacing challenge classical biventricular pacing. This article reviews current strategies for a successful planning, implementation, and validation of the optimal CRT implantation. Pre-implant imaging modalities offer promising assistance for complex cases; empirical lead positioning and intraoperative testing remain the cornerstone in most cases and ensure a successful CRT effect.

[Position paper on required competencies of nonphysician employees in telemedicine centers]. / Positionspapier zum Anforderungsprofil von nichtärztlichen Assistenzkräften in Telemedizinzentren.

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.

[Artificial intelligence in cardiology : Relevance, current applications, and future developments]. / Künstliche Intelligenz in der Kardiologie : Relevanz, aktuelle Anwendungen und nächste Schritte.

Big data and applications of artificial intelligence (AI), such as machine learning or deep learning, will enrich healthcare in the future and become increasingly important. Among other things, they have the potential to avoid unnecessary examinations as well as diagnostic and therapeutic errors. They could enable improved, early and accelerated decision-making. In the article, the authors provide an overview of current AI-based applications in cardiology. The examples describe innovative solutions for risk assessment, diagnosis and therapy support up to patient self-management. Big data and AI serve as a basis for efficient, predictive, preventive and personalised medicine. However, the examples also show that research is needed to further develop the solutions for the benefit of the patient and the medical profession, to demonstrate the effectiveness and benefits in health care and to establish legal and ethical standards.

Changes in treatment for NSTEMI in women and the elderly over the past 16 years in a large real-world population.

AIMS: This study investigates the changes in therapy for Non-ST-Elevation Myocardial Infarction (NSTEMI) over the past 16 years in a large German registry. In particular, the high-risk population of female and elderly patients was analyzed. METHODS: In total, 19.383 patients presenting with NSTEMI were included in this study. Patients were stratified by age groups <75 years and ≥75 years and by sex. Four different time periods from 2000-2004, 2005-2008, 2009-2012 and 2013-2016 were compared. Influence on hospital mortality as the primary outcome measure was assessed by logistic regression analysis. Secondary outcome measures included percutaneous coronary intervention (PCI), the use of drug eluting stents (DES), radial access route and major adverse cardiovascular events (MACE), defined as all-cause mortality, stroke, re-infarction, percutaneous re-intervention, intervention-related bleeding, cardiopulmonary resuscitation and new onset of cardiogenic shock or need for mechanical ventilation. RESULTS: Mortality decreased in all age groups between the initial time period and the most recent one (8.9% vs. 4.5%, p < 0.01), particularly in female patients ≥75 years (18.2% in 2000-2004 vs. 7.9% in 2013-2016, p < 0.01). Revascularization rates differed by gender (68.3% in women vs. 78.1% in men, p < 0.01) and by age (64.2% for ≥75 years vs. 80.9% for <75 years, p < 0.01). PCI rates in elderly female patients increased from 28.7% to 69.8% (p < 0.01) from the initial to the latest period. CONCLUSIONS: The present study demonstrates, that revascularization rates improved in all patient groups over the study period. However, females and elderly patients still remain less likely to be treated according to current guidelines.

A validation study of intraoperative performance metrics for training novice cardiac resynchronization therapy implanters.

AIMS: Pacing/cardiac resynchronization therapy (CRT) implant training currently lacks a common system to objectively assess trainee ability to perform required tasks at predetermined performance levels. The purpose of this study was to primarily examine construct validity and reliability, secondarily discriminative validity of novel intraoperative performance metrics, developed for a reference approach to training novice CRT implanters. METHODS: Fifteen novice and eleven experienced CRT implanters performed a 3-lead implant procedure on a virtual reality simulator. Performances were video-recorded, then independently scored using predefined metrics endorsed by an international panel of experts. First, Novice and Experienced group scores were compared for steps completed and errors made. Secondly, each group was split in two around the median score of the group and subgroup scores were compared. RESULTS: The mean number of scored metrics per performance was 108 and the inter-rater reliability for scoring was 0.947. Compared with novices, experienced implanters completed more procedural Steps correctly (mean 87% vs. 73%, p = 0.001), made fewer procedural Errors (6.3 vs. 11.2, p = 0.005), Critical Errors (1.8 vs. 4.4, p = 0.004), and total errors (8.1 vs. 15.6, p = 0.002). Furthermore, the differences between the two Novice subgroups were 25% for steps completed correctly and 94% for total errors made (p < 0.001); the differences between the two Experienced subgroups were respectively 16% and 191% (p < 0.001). CONCLUSIONS: The procedure metrics used in this study reliably distinguish novice and experienced CRT implanters' performances. The metrics further differentiated performance levels within a group with similar experience. These performance metrics will underpin quality-assured novice implanter training.

International expert consensus on a scientific approach to training novice cardiac resynchronization therapy implanters using performance quality metrics.

AIMS: Pacing and Cardiac Resynchronization Therapy (CRT) procedural training for novice operators usually takes place in-vivo and methods vary across countries/institutions. No common system exists to objectively assess trainee ability to perform required tasks at predetermined performance levels prior to in-vivo practice. We sought to characterize and validate with experts a reference approach to pacing/CRT implants based on objective and explicit performance quality metrics, for the development of a reproducible, simulation-based, training curriculum aiming to operator proficiency. METHODS: Three experienced CRT implanters, a behavioural scientist and two engineers performed a detailed task deconstruction of the pacing/CRT procedure and identified the performance metrics (phases, steps, errors, critical errors) that constitute an optimal CRT implant for training purposes. The metrics were stress tested to determine reliability and score-ability and then subjected to detailed systematic review by an international panel of 15 expert implanters in a modified Delphi process. RESULTS: Thirteen procedure phases were identified, consisting of 196 steps, 122 errors, 50 critical errors. The expert panel deliberation added 16 metrics, deleted 12, and modified 43. Unanimous panel consensus on the resulting CRT procedure metrics was obtained, which verified face and content validity. CONCLUSION: A reference pacing/CRT procedure and metrics created by a core group of experts accurately characterize the essential components of performance and were endorsed by an international panel of experienced peers. The metrics will underpin quality-assured novice implanter training.

Atrioventricular dromotropathy: evidence for a distinctive entity in heart failure with prolonged PR interval?

Heart failure (HF) is often accompanied by atrioventricular (AV) conduction disturbance, represented by prolongation of the PR interval on the electrocardiogram. Studies suggest that PR prolongation exists in at least 10% of HF patients, and it seems more prevalent in the presence of prolonged QRS duration. A prolonged PR interval may result in elevated left ventricular (LV) end-diastolic pressure, diastolic mitral regurgitation, and reduced LV pump function. This seems especially the case in patients with heart disease, in whom it is associated with an increased risk for atrial fibrillation, advanced AV heart block, HF, and death. These findings point towards the importance of proper AV coupling in HF patients. A few studies, strongly differing in design, suggest that restoration of AV coupling in patients with PR prolongation by pacing improves cardiac function and clinical outcomes. These observations argue for AV-dromotropathy as a potential target for pacing therapy, but other studies show inconsistent results. Given its potential clinical implications, restoration of AV coupling by pacing warrants further investigation. Additional possible future research goals include assessing different techniques to measure compromised AV coupling, determine the best site(s) of ventricular pacing, and assess a potential influence of diastolic mitral regurgitation in the efficacy of such therapy.

[Non-device-based telemonitoring : Toy or tool?] / Nicht implantatbasiertes Telemonitoring : "Toy or tool?".

Non-device-based telemedical management can be useful to prevent decompensation and death in patients suffering from easily disequilibrated conditions like diabetes mellitus, chronic obstructive pulmonary disease and heart failure (HF). This article summarizes current knowledge on non-device-based telemedical care for patients with HF. Several parameters (heart rate, heart rate variability, systolic blood pressure, pulse pressure, body weight, physical activity as derived from accelerometry, and occurrence of atrial and ventricular arrhythmias) have been identified as being associated with imminent clinical deterioration of HF patients. Structured telephone-based support and noninvasive telemonitoring with integrated electronic transfer of physiological data have been applied to care for HF patients and have been evaluated in multiple studies. The impact of telemedical care on clinical outcome appears to depend on the applied telemedical configuration and on the disease severity of targeted populations. The exclusive use of an automated telephone response system has not been successful. In patients with optimal medical therapy and relatively low decompensation risk noninvasive telemonitoring did not significantly reduce mortality. Nevertheless meta-analyses of structured telephone support and of noninvasive telemonitoring combining knowledge from available randomized trials suggest that both of these telemedical approaches may reduce the mortality risk of HF patients by 13-20%. The results of the Telemedical Interventional Management in Heart Failure II (TIM-HF II) trial on noninvasive telemonitoring versus usual care in 1500 high-risk HF patients are awaited in 2018 and will further clarify the usefulness of telemedical care in this field.

The Emergency Medical Care of Patients With Acute Myocardial Infarction.

BACKGROUND: Optimizing the emergency medical care chain might shorten the time to treatment of patients with ST-elevation myocardial infarction (STEMI). The initial care by a physician, and, in particular, correct ECG interpretation, are critically important factors. METHODS: From 1999 onward, data on the care of patients with myocardial infarction have been recorded and analyzed in the Berlin Myocardial Infarction Registry. In the First Medical Contact Study, data on initial emergency medical care were obtained on 1038 patients who had been initially treated by emergency physicians in 2012. Their pre-hospital ECGs were re-evaluated in a blinded fashion according to the criteria of the European Society of Cardiology. RESULTS: The retrospective re-evaluation of pre-hospital ECGs revealed that 756 of the 1038 patients had sustained a STEMI. The emergency physicians had correctly diagnosed STEMI in 472 patients (62.4%), and they had correctly diagnosed ventricular fibrillation in 85 patients (11.2%); in 199 patients (26.3%), the ECG interpretation was unclear. The pre-hospital ECG interpretation was significantly associated with the site of initial hospitalization and the ensuing times to treatment. In particular, the time from hospital admission to cardiac catheterization was longer in patients with an unclear initial ECG interpretation than in those with correctly diagnosed STEMI (121 [54; 705] vs. 36 [19; 60] minutes, p <0.001). After multivariate adjustment, this corresponded to a hazard ratio* of 2.67 [2.21; 3.24]. CONCLUSION: Pre-hospital ECG interpretation in patients with STEMI was a trigger factor with a major influence on the time to treatment in the hospital. The considerable percentage of pre-hospital ECGs whose interpretation was unclear implies that there is much room for improvement.

Sustained clinical benefit of cardiac resynchronization therapy in non-LBBB patients with prolonged PR-interval: MADIT-CRT long-term follow-up.

OBJECTIVE: In MADIT-CRT, patients with non-LBBB (right bundle branch block or nonspecific ventricular conduction delay) and a prolonged PR-interval derived significant clinical benefit from cardiac resynchronization therapy with defibrillator (CRT-D) compared to an implantable cardioverter defibrillator (ICD)-only. We aimed to study the long-term outcome of non-LBBB patients by baseline PR-interval with CRT-D versus ICD-only. METHODS: Non-LBBB patients (n = 534) were dichotomized based on baseline PR-interval: normal PR (PR < 230 ms), and markedly prolonged PR (PR ≥ 230 ms). The primary end point was heart failure (HF) or death. Secondary end points were HF only and all-cause death. RESULTS: In patients with a prolonged PR-interval, CRT-D treatment related to a 67 % significant reduction in the risk of HF/death (HR = 0.33, 95 % CI 0.16-0.69, p = 0.003), 69 % decrease in HF (HR = 0.31, 95 % CI 0.14-0.68, p = 0.003), and 76 % reduction in the risk of death (HR = 0.24, 95 % CI 0.07-0.80, p = 0.020) compared to ICD-only (median follow-up 5.8 years). In normal PR-interval patients, CRT-D therapy was associated with a trend towards increased risk of HF/death (HR = 1.49, 95 % CI 0.98-2.25, p = 0.061), and significantly increased mortality (HR = 2.27, 95 % CI 1.16-4.44, p = 0.014). Significant statistical interaction with the PR-interval was demonstrated for all end points. Results were consistent for QRS 130-150 ms and QRS > 150 ms. CONCLUSION: In MADIT-CRT, non-LBBB patients with a prolonged PR-interval derive sustained long-term clinical benefit with reductions in heart failure or death from CRT-D implantation, compared to an ICD-only. Our findings support implantation of CRT-D in non-LBBB patients with prolonged PR-interval irrespective of baseline QRS duration.