Percutaneous repair of moderate-to-severe or severe functional mitral regurgitation in patients with symptomatic heart failure: Baseline characteristics of patients in the RESHAPE-HF2 trial and comparison to COAPT and MITRA-FR trials.

AIM: The RESHAPE-HF2 trial is designed to assess the efficacy and safety of the MitraClip device system for the treatment of clinically important functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline characteristics of patients enrolled in the RESHAPE-HF2 trial compared to those enrolled in the COAPT and MITRA-FR trials. METHODS AND RESULTS: The RESHAPE-HF2 study is an investigator-initiated, prospective, randomized, multicentre trial including patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50% with moderate-to-severe or severe FMR, for whom isolated mitral valve surgery was not recommended. Patients were randomized 1:1 to a strategy of delivering or withholding MitraClip. Of 506 patients randomized, the mean age of the patients was 70 ± 10 years, and 99 of them (20%) were women. The median EuroSCORE II was 5.3 (2.8-9.0) and median plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 2745 (1407-5385) pg/ml. Most patients were prescribed beta-blockers (96%), diuretics (96%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors (82%) and mineralocorticoid receptor antagonists (82%). The use of sodium-glucose cotransporter 2 inhibitors was rare (7%). Cardiac resynchronization therapy (CRT) devices had been previously implanted in 29% of patients. Mean LVEF, left ventricular end-diastolic volume and effective regurgitant orifice area (EROA) were 31 ± 8%, 211 ± 76 ml and 0.25 ± 0.08 cm2, respectively, whereas 44% of patients had mitral regurgitation severity of grade 4+. Compared to patients enrolled in COAPT and MITRA-FR, those enrolled in RESHAPE-HF2 were less likely to have mitral regurgitation grade 4+ and, on average, HAD lower EROA, and plasma NT-proBNP and higher estimated glomerular filtration rate, but otherwise had similar age, comorbidities, CRT therapy and LVEF. CONCLUSION: Patients enrolled in RESHAPE-HF2 represent a third distinct population where MitraClip was tested in, that is one mainly comprising of patients with moderate-to-severe FMR instead of only severe FMR, as enrolled in the COAPT and MITRA-FR trials. The results of RESHAPE-HF2 will provide crucial insights regarding broader application of the transcatheter edge-to-edge repair procedure in clinical practice.

Managing Implanted Cardiac Electronic Devices in Patients With Severe Tricuspid Regurgitation: JACC State-of-the-Art Review.

Orthotopic transcatheter tricuspid valve replacement (TTVR) devices have been shown to be highly effective in reducing tricuspid regurgitation (TR), and interest in this therapy is growing with the recent commercial approval of the first orthotopic TTVR. Recent TTVR studies report preexisting cardiac implantable electronic device (CIED) transvalvular leads in ∼35% of patients, with entrapment during valve implantation. Concerns have been raised regarding the safety of entrapping leads and counterbalanced against the risks of transvenous lead extraction (TLE) when indicated. This Heart Valve Collaboratory consensus document attempts to define the patient population with CIED lead-associated or lead-induced TR, describe the risks of lead entrapment during TTVR, delineate the risks and benefits of TLE in this setting, and develop a management algorithm for patients considered for TTVR. An electrophysiologist experienced in CIED management should be part of the multidisciplinary heart team and involved in shared decision making.

Leadless Pacemaker Implantation in Patients With a Prior Conventional Pacing System.

Background: Leadless pacing has been established as an alternative approach to transvenous devices for selected patients. Often, leadless pacemaker (LP) implantation is a de novo procedure, but in an increasing number of patients, an LP is used after previous implantation of a conventional pacing system (CPS). Methods: A retrospective analysis was conducted of the efficacy and safety of LP implantation in the context of a previously implanted CPS, from 2 large Swiss centres. Results: A total of 257 consecutive patients undergoing LP implantation were included. They were divided into 2 groups: group 1 consisted of 233 patients who did not have a previous CPS, and group 2 consisted of 24 patients with an in situ CPS. In group 2, a total of 20 patients (83%) required transvenous lead extraction due to infection, malfunction, or other reasons. In 3 patients with device-related infection, lead extraction and LP implantation was performed as a single procedure, whereas in the remaining 11 cases, a time window occurred between the 2 procedures (median: 11.5 days; range: 2-186 days). Electrical device parameters at implantation and during follow-up did not differ between the 2 groups (mean: 12.5 ± 9.3 months). Eight major periprocedural complications (3.1%) were encountered (4 pericardial effusions, 3 instances of femoral bleeding, and 1 instance of intra-abdominal bleeding) in the entire cohort within a 30-day period. No complications occurred in the group with a previous device. No infections were registered, even when complete extraction of an infected CPS was performed prior to LP implantation. Conclusions: Implantation of an LP in patients with a prior CPS (with or without extraction of the previous system) was effective and safe in our population of patients.

Contexte: La stimulation cardiaque sans fil a été établie comme une solution de substitution aux dispositifs transveineux chez certains patients. L'implantation d'un stimulateur cardiaque sans fil est souvent une intervention de novo, mais chez un nombre croissant de patients, ce type de stimulateur est utilisé après l'implantation d'un stimulateur classique. Méthodologie: Une analyse rétrospective de l'efficacité et de l'innocuité de la stimulation cardiaque sans fil dans le contexte de l'implantation d'un stimulateur classique a été réalisée dans deux grands centres suisses. Résultats: Un total de 257 patients consécutifs ayant subi l'implantation d'un stimulateur cardiaque sans fil ont été inclus. Les patients étaient répartis dans deux groupes; le groupe 1 était composé de 233 patients non porteurs d'un stimulateur classique, et le groupe 2, de 24 patients porteurs d'un stimulateur classique in situ. Dans le groupe 2, 20 patients au total (83 %) ont eu besoin d'une extraction de la sonde transveineuse en raison d'une infection, d'un défaut de fonctionnement, ou pour d'autres motifs. Chez 3 patients présentant une infection liée au stimulateur, l'extraction de la sonde et l'implantation d'un stimulateur cardiaque sans fil ont été réalisées simultanément, tandis que dans les 11 autres cas, il s'est écoulé un temps médian de 11,5 jours entre les deux interventions (min.-max. : 2-186 jours). Les paramètres relatifs au dispositif électrique au moment de l'implantation et pendant le suivi n'étaient pas différents entre les deux groupes (moyenne : 12,5 ± 9,3 mois). Huit complications périopératoires importantes (3,1 %) sont survenues (4 cas d'épanchement péricardique, 3 cas d'hémorragie fémorale et 1 cas d'hémorragie intra-abdominale) dans l'ensemble de la cohorte au cours d'une période de 30 jours. Aucune complication ne s'est produite dans le groupe de patients porteurs d'un stimulateur classique. On n'a enregistré aucun cas d'infection, même lorsque l'extraction complète du stimulateur classique infecté a été effectuée avant l'implantation du stimulateur cardiaque sans fil. Conclusions: L'implantation d'un stimulateur cardiaque sans fil chez les patients porteurs d'un stimulateur classique (avec ou sans extraction de ce stimulateur) était une intervention efficace et sûre dans cette population de patients.

Leadless Pacemaker Implantation, Focusing on Patients With Conduction System Disorders Post-Transcatheter Aortic Valve Replacement: A Retrospective Analysis.

Background: Impairment of the conduction system is a common complication of transcatheter aortic valve replacement (TAVR), which is typically performed in elderly patients. A leadless pacemaker (LP) may be a suitable option in this frail population, but the available scientific data concerning the efficacy and safety of leadless pacing after TAVR are sparse. The purpose of this analysis was to evaluate the efficacy and safety of LP implantation in patients with relevant bradycardias after TAVR, compared to other indications. Methods: Consecutive patients were retrospectively enrolled. Demographics, background heart diseases, interventional parameters, and follow-up data were collected. Results: A total of 257 consecutive patients who underwent LP implantation were included. In 26 patients, the device was implanted due to bradycardias after TAVR (TAVR group), whereas the remaining 231 patients were in the population without previous TAVR (non-TAVR group). The mean implantation duration (56 ± 22 minutes in the TAVR group vs 48 ± 20 minutes in the non-TAVR group; P = not significant [NS]) and the implantation success rate (100% in the TAVR group vs 98.7% in the non-TAVR group; P = NS) were similar in the 2 cohorts. No significant differences occurred in pacing parameters (sensing, impedance, and threshold, respectively) between the 2 groups, either at implantation or during follow-up. A total of 8 major periprocedural complications (3.1% of patients in total; 3.8% in the TAVR group vs 3.0% in the non-TAVR group; P = NS) occurred within 30 days, without significant difference between the 2 groups. Conclusions: LP implantation appears to be safe and effective in patients after TAVR, and therefore, this procedure is a suitable option for this often old and frail population.

Contexte: L'atteinte du système de conduction cardiaque est une complication courante du remplacement valvulaire aortique par cathéter (RVAC), une intervention habituellement pratiquée chez les patients âgés. Un stimulateur cardiaque sans sonde peut être une option convenable pour cette population fragile, mais les données scientifiques actuelles concernant l'efficacité et l'innocuité de la stimulation sans sonde après un RVAC sont fragmentaires. Cette analyse visait à évaluer l'efficacité et l'innocuité de l'implantation d'un stimulateur cardiaque sans sonde chez des patients atteints de bradycardies pertinentes après un RVAC, comparativement à d'autres indications. Méthodologie: Des patients consécutifs ont été recrutés de manière rétrospective. Les données démographiques, les maladies cardiaques sous-jacentes, les paramètres interventionnels et les données de suivi ont été colligés. Résultats: Un total de 257 patients consécutifs qui se sont fait implanter un stimulateur cardiaque sans sonde ont été inclus. Chez 26 patients, le dispositif a été implanté en raison d'une bradycardie après un RVAC (groupe RVAC), alors que les 231 autres patients formaient la population sans RVAC antérieur (groupe sans RVAC). La durée moyenne de l'intervention d'implantation (56 ± 22 minutes dans le groupe RVAC vs 48 ± 20 minutes dans le groupe sans RVAC; p = non significatif [NS]) et le taux de réussite de l'implantation (100 % dans le groupe RVAC vs 98,7 % dans le groupe sans RVAC; p = NS) étaient similaires dans les deux cohortes. Aucune différence significative n'a été observée dans les paramètres de stimulation (sensibilité, impédance et seuil, respectivement) entre les 2 groupes, que ce soit au moment de l'implantation ou pendant le suivi. Un total de 8 complications périopératoires majeures (3,1 % de l'ensemble des patients; 3,8 % dans le groupe RVAC vs 3,0 % dans le groupe sans RVAC; p = NS) sont survenues dans les 30 jours, sans différence notable entre les 2 groupes. Conclusions: L'implantation d'un stimulateur cardiaque sans sonde semble sûre et efficace après un RVAC; par conséquent, cette intervention représente une option convenable pour cette population souvent âgée et fragile.

Atrioventricular optimization improves cardiac resynchronization response in patients with long interventricular electrical delays: A pooled analysis of the SMART-AV and SMART-CRT trials.

BACKGROUND: The utility of atrioventricular (AV) optimization (AVO) algorithms remains in question. A substudy of the SMART-AV trial found that patients with prolonged interventricular delays ≥70 ms were more likely to benefit from cardiac resynchronization therapy (CRT) with AVO. The SMART-CRT trial evaluated AVO on the basis of these results, but the study was underpowered. OBJECTIVE: To increase statistical power, data from SMART-AV patients meeting the inclusion criterion of interventricular delay ≥70 ms were pooled with data from SMART-CRT to reassess AVO. METHODS: SMART-CRT and SMART-AV were prospective, randomized, multicenter clinical trials. Patients in both studies were randomized to be programmed with an AVO algorithm (SmartDelay) or fixed AV delay (120 ms). Paired echocardiograms obtained at baseline and 6 months were compared, with CRT response defined as ≥15% reduction in left ventricular end-systolic volume. RESULTS: A total of 451 complete patient data sets were pooled and analyzed. The baseline demographics between studies did not differ statistically in terms of age, sex, left ventricular ejection fraction, or left ventricular end-systolic volume. The AVO group had a greater proportion of CRT responders (SmartDelay, 73.9%; fixed, 63.1%; P = .014) and greater changes in measures of reverse remodeling. SmartDelay patients with a recommended sensed AV delay outside the nominal range (100-120 ms) had 2.3 greater odds of CRT response than fixed AV delay patients. CONCLUSION: Greater CRT response and measures of reverse remodeling were observed in patients with SmartDelay enabled vs a fixed AV delay. This study supports the use of SmartDelay in patients with a CRT indication and interventricular delay ≥70 ms. GOV REGISTRATION: NCT00677014 and NCT03089281.

Implantable loop recorders in patients with Brugada syndrome: the BruLoop study.

BACKGROUND AND AIMS: Available data on continuous rhythm monitoring by implantable loop recorders (ILRs) in patients with Brugada syndrome (BrS) are scarce. The aim of this multi-centre study was to evaluate the diagnostic yield and clinical implication of a continuous rhythm monitoring strategy by ILRs in a large cohort of BrS patients and to assess the precise arrhythmic cause of syncopal episodes. METHODS: A total of 370 patients with BrS and ILRs (mean age 43.5 ± 15.9, 33.8% female, 74.1% symptomatic) from 18 international centers were included. Patients were followed with continuous rhythm monitoring for a median follow-up of 3 years. RESULTS: During follow-up, an arrhythmic event was recorded in 30.7% of symptomatic patients [18.6% atrial arrhythmias (AAs), 10.2% bradyarrhythmias (BAs), and 7.3% ventricular arrhythmias (VAs)]. In patients with recurrent syncope, the aetiology was arrhythmic in 22.4% (59.3% BAs, 25.0% VAs, and 15.6% AAs). The ILR led to drug therapy initiation in 11.4%, ablation procedure in 10.9%, implantation of a pacemaker in 2.5%, and a cardioverter-defibrillator in 8%. At multivariate analysis, the presence of symptoms [hazard ratio (HR) 2.5, P = .001] and age >50 years (HR 1.7, P = .016) were independent predictors of arrhythmic events, while inducibility of ventricular fibrillation at the electrophysiological study (HR 9.0, P < .001) was a predictor of VAs. CONCLUSIONS: ILR detects arrhythmic events in nearly 30% of symptomatic BrS patients, leading to appropriate therapy in 70% of them. The most commonly detected arrhythmias are AAs and BAs, while VAs are detected only in 7% of cases. Symptom status can be used to guide ILR implantation.

Mortality Benefit Among Primary Prevention Implantable Cardioverter-Defibrillator Recipients on Contemporary Heart Failure Treatment.

BACKGROUND: Past clinical trials have shown the benefit of implantable cardioverter-defibrillators (ICDs) for reducing sudden cardiac death in at-risk patients. However, heart failure management and ICD technology have changed since these trials were first published. An updated assessment of ICD mortality benefit is needed. OBJECTIVES: The purpose of this study was to compare mortality rates between patients with a primary prevention (PP) indication for an ICD who did or did not receive an ICD using a contemporary, real-world data set. METHODS: Data was obtained from a large electronic health record data set covering patients in the United States from 2012 through 2020 who had a PP indication for an ICD and survived at least 1-year postindication. RESULTS: A total of 25,296 patients were identified as having a PP indication for ICD implantation, of which 2,118 (8.4%) were treated with an ICD within a year. Treated patients were younger than nontreated patients (age 63.4 years vs 66.1 years) with a smaller proportion of women (25.0% vs 36.7%). After 4-to-1 propensity matching, treated patients had similar clinical characteristics to nontreated patients. A Cox proportional hazard model estimated a 24.3% lower risk of all-cause mortality in patients when treated vs not treated with an ICD (HR: 0.757; 95% CI: 0.678-0.835; P <0.001). There was no detectable difference in ICD benefit between patients with ischemic and nonischemic heart disease (P = 0.50). CONCLUSIONS: ICD treatment of patients with a PP indication is associated with improved mortality even in the context of evolving adjunctive HF treatment, consistent with earlier landmark trials.

Cardiac implantable electronic devices and bloodstream infections: management and outcomes.

BACKGROUND AND AIMS: Bloodstream infection (BSI) of any cause may lead to device infection in cardiac implantable electronic device (CIED) patients. Aiming for a better understanding of the diagnostic approach, treatment, and outcome, patients with an implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy and defibrillator (CRT-D) hospitalized with BSI were investigated. METHODS: This is a single-centre, retrospective, cohort analysis including consecutive ICD/CRT-D patients implanted between 2012 and 2021. These patients were screened against a list of all hospitalized patients having positive blood cultures consistent with diagnosed infection in any department of a local public hospital. RESULTS: The total cohort consisted of 515 patients. Over a median follow-up of 59 months (interquartile range 31-87 months), there were 47 BSI episodes in 36 patients. The majority of patients with BSI (92%) was admitted to non-cardiology units, and in 25 episodes (53%), no cardiac imaging was performed. Nearly all patients (85%) were treated with short-term antibiotics, whereas chronic antibiotic suppression therapy (n = 4) and system extraction (n = 3) were less frequent. Patients with BSI had a nearly seven-fold higher rate (hazard ratio 6.7, 95% confidence interval 3.9-11.2; P < .001) of all-cause mortality. CONCLUSIONS: Diagnostic workup of defibrillator patients with BSI admitted to a non-cardiology unit is often insufficient to characterize lead-related endocarditis. The high mortality rate in these patients with BSI may relate to underdiagnosis and consequently late/absence of system removal. Efforts to increase an interdisciplinary approach and greater use of cardiac imaging are necessary for timely diagnosis and adequate treatment.

Validation of Utstein-Based score to predict return of spontaneous circulation (UB-ROSC) in patients with out-of-hospital cardiac arrest.

BACKGROUND AND AIMS: The Utstein Based-ROSC (UB-ROSC) score has been developed to predict ROSC in OHCA victims. Aim of the study was to validate the UB-ROSC score using two Utstein-based OHCA registries: the SWiss REgistry of Cardiac Arrest (SWISSRECA) and the Lombardia Cardiac Arrest Registry (Lombardia CARe), northern Italy. METHODS: Consecutive patients with OHCA of any etiology occurring between January 1st, 2019 and December 31st 2021 were included in this retrospective validation study. UB-ROSC score was computed for each patient and categorized in one of three subgroups: low, medium or high likelihood of ROSC according to the UB-ROSC cut-offs (≤-19; -18 to 12; ≥13). To assess the performance of the UB-ROSC score in this new cohort, we assessed both discrimination and calibration. The score was plotted against the survival to hospital admission. RESULTS: A total of 12.577 patients were included in the study. A sustained ROSC was obtained in 2.719 patients (22%). The UB-ROSC model resulted well calibrated and showed a good discrimination (AUC 0.71, 95% CI 0.70-0.72). In the low likelihood subgroup of UB-ROSC, only 10% of patients achieved ROSC, whereas the proportion raised to 36% for a score between -18 and 12 (OR 5.0, 95% CI 2.9-8.6, p < 0.001) and to 85% for a score ≥13 (OR 49.4, 95% CI 14.3-170.6, p < 0.001). CONCLUSIONS: UB-ROSC score represents a reliable tool to predict ROSC probability in OHCA patients. Its application may help the medical decision-making process, providing a realistic stratification of the probability for ROSC.

The impact of COVID-19 pandemic on out-of-hospital cardiac arrest: An individual patient data meta-analysis.

AIM: Prior studies have reported increased out-of-hospital cardiac arrests (OHCA) incidence and lower survival during the COVID-19 pandemic. We evaluated how the COVID-19 pandemic affected OHCA incidence, bystander CPR rate and patients' outcomes, accounting for regional COVID-19 incidence and OHCA characteristics. METHODS: Individual patient data meta-analysis of studies which provided a comparison of OHCA incidence during the first pandemic wave (COVID-period) with a reference period of the previous year(s) (pre-COVID period). We computed COVID-19 incidence per 100,000 inhabitants in each of 97 regions per each week and divided it into its quartiles. RESULTS: We considered a total of 49,882 patients in 10 studies. OHCA incidence increased significantly compared to previous years in regions where weekly COVID-19 incidence was in the fourth quartile (>136/100,000/week), and patients in these regions had a lower odds of bystander CPR (OR 0.49, 95%CI 0.29-0.81, p = 0.005). Overall, the COVID-period was associated with an increase in medical etiology (89.2% vs 87.5%, p < 0.001) and OHCAs at home (74.7% vs 67.4%, p < 0.001), and a decrease in shockable initial rhythm (16.5% vs 20.3%, p < 0.001). The COVID-period was independently associated with pre-hospital death (OR 1.73, 95%CI 1.55-1.93, p < 0.001) and negatively associated with survival to hospital admission (OR 0.68, 95%CI 0.64-0.72, p < 0.001) and survival to discharge (OR 0.50, 95%CI 0.46-0.54, p < 0.001). CONCLUSIONS: During the first COVID-19 pandemic wave, there was higher OHCA incidence and lower bystander CPR rate in regions with a high-burden of COVID-19. COVID-19 was also associated with a change in patient characteristics and lower survival independently of COVID-19 incidence in the region where OHCA occurred.

Deep Generative Models: The winning key for large and easily accessible ECG datasets?

Large high-quality datasets are essential for building powerful artificial intelligence (AI) algorithms capable of supporting advancement in cardiac clinical research. However, researchers working with electrocardiogram (ECG) signals struggle to get access and/or to build one. The aim of the present work is to shed light on a potential solution to address the lack of large and easily accessible ECG datasets. Firstly, the main causes of such a lack are identified and examined. Afterward, the potentials and limitations of cardiac data generation via deep generative models (DGMs) are deeply analyzed. These very promising algorithms have been found capable not only of generating large quantities of ECG signals but also of supporting data anonymization processes, to simplify data sharing while respecting patients' privacy. Their application could help research progress and cooperation in the name of open science. However several aspects, such as a standardized synthetic data quality evaluation and algorithm stability, need to be further explored.

Identification of Brugada syndrome based on P-wave features: an artificial intelligence-based approach.

AIMS: Brugada syndrome (BrS) is an inherited disease associated with an increased risk of ventricular arrhythmias. Recent studies have reported the presence of an altered atrial phenotype characterized by abnormal P-wave parameters. The aim of this study was to identify BrS based exclusively on P-wave features through an artificial intelligence (AI)-based model. METHODS AND RESULTS: Continuous 5 min 12-lead ECG recordings were obtained in sinus rhythm from (i) patients with spontaneous or ajmaline-induced BrS and no history of AF and (ii) subjects with suspected BrS and negative ajmaline challenge. The recorded ECG signals were processed and divided into epochs of 15 s each. Within these epochs, P-waves were first identified and then averaged. From the averaged P-waves, a total of 67 different features considered relevant to the classification task were extracted. These features were then used to train nine different AI-based supervised classifiers. A total of 2228 averaged P-wave observations, resulting from the analysis of 33 420 P-waves, were obtained from 123 patients (79 BrS+ and 44 BrS-). Averaged P-waves were divided using a patient-wise split, allocating 80% for training and 20% for testing, ensuring data integrity and reducing biases in AI-based model training. The BrS+ patients presented with longer P-wave duration (136 ms vs. 124 ms, P < 0.001) and higher terminal force in lead V1 (2.5 au vs. 1.7 au, P < 0.01) compared with BrS- subjects. Among classifiers, AdaBoost model had the highest values of performance for all the considered metrics, reaching an accuracy of over 81% (sensitivity 86%, specificity 73%). CONCLUSION: An AI machine-learning model is able to identify patients with BrS based only on P-wave characteristics. These findings confirm the presence of an atrial hallmark and open new horizons for AI-guided BrS diagnosis.

A roadmap to building first responder networks: Lessons learned and best practices from Belgium and Switzerland.

Background/Aims: Limited bystander assistance and delayed emergency medical service arrival reduce the chances of survival in cardiac arrest victims. Early basic life support through trained first responders (FR) and automatic external defibrillation both improve the outcome. Well-organized FR networks have shown promise, but guidance on effective implementation is lacking. This study evaluates two FR networks, in Belgium and in Switzerland, to identify main advancements in the development of such systems. Method: Direct comparison is made of the barriers and facilitators in the development of both FR systems from 2006 up until December 2022, and summarized within a roadmap. Results: The Roadmap comprises four integral steps: exploration, installation, initiation, and implementation. Exploration involves understanding the national legislation, engaging with advisory bodies, and establishing local steering committees. The installation phase focuses on FR recruitment, engaging specific professional groups such as firemen, registering public Automated External Defibrillators (AEDs), and requesting feedback. The initiation step includes implementing improvement cycles and fidelity measures. Finally, implementation expands the network, leading to increased survival rates and the integration of these practices into legislation. A significant focus is placed on FR's psychological wellbeing. Moreover, the roadmap highlights the use of efficient geo-mapping to simplify optimal AED placement and automatically assign FRs to tasks. Conclusion: The importance of FR networks for early resuscitation is increasingly recognized and various systems are being developed. Key developmental strategies of the EVapp and Ticino Cuore app system may serve as a roadmap for other systems and implementations within Europe and beyond.

The evolving state of cardiac resynchronization therapy and conduction system pacing: 25 years of research at EP Europace journal.

Cardiac resynchronization therapy (CRT) was proposed in the 1990s as a new therapy for patients with heart failure and wide QRS with depressed left ventricular ejection fraction despite optimal medical treatment. This review is aimed first to describe the rationale and the physiologic effects of CRT. The journey of the landmark randomized trials leading to the adoption of CRT in the guidelines since 2005 is also reported showing the high level of evidence for CRT. Different alternative pacing modalities of CRT to conventional left ventricular pacing through the coronary sinus have been proposed to increase the response rate to CRT such as multisite pacing and endocardial pacing. A new emerging alternative technique to conventional biventricular pacing, conduction system pacing (CSP), is a promising therapy. The different modalities of CSP are described (Hirs pacing and left bundle branch area pacing). This new technique has to be evaluated in clinical randomized trials before implementation in the guidelines with a high level of evidence.

Transvenous Lead Extraction during Cardiac Implantable Device Upgrade: Results from the Multicenter Swiss Lead Extraction Registry.

BACKGROUND: Device patients may require upgrade interventions from simpler to more complex cardiac implantable electronic devices. Prior to upgrading interventions, clinicians need to balance the risks and benefits of transvenous lead extraction (TLE), additional lead implantation or lead abandonment. However, evidence on procedural outcomes of TLE at the time of device upgrade is scarce. METHODS: This is a post hoc analysis of the investigator-initiated multicenter Swiss TLE registry. The objectives were to assess patient and procedural factors influencing TLE outcomes at the time of device upgrades. RESULTS: 941 patients were included, whereof 83 (8.8%) had TLE due to a device upgrade. Rotational mechanical sheaths were more often used in upgraded patients (59% vs. 42.7%, p = 0.015) and total median procedure time was longer in these patients (160 min vs. 105 min, p < 0.001). Clinical success rates of upgraded patients compared to those who received TLE due to other reasons were not different (97.6% vs. 93.0%, p = 0.569). Moreover, multivariable analysis showed that upgrade procedures were not associated with a greater risk for complications (HR 0.48, 95% confidence interval 0.14-1.57, p = 0.224; intraprocedural complication rate of upgraded patients 7.2% vs. 5.5%). Intraprocedural complications of upgraded patients were mostly associated with the implantation and not the extraction procedure (67% vs. 33% of complications). CONCLUSIONS: TLE during device upgrade is effective and does not attribute a disproportionate risk to the upgrade procedure.

Atrial Fibrillation Burden and Atrial Shunt Therapy in Heart Failure With Preserved Ejection Fraction.

BACKGROUND: Atrial fibrillation (AF) is a common comorbidity in patients with heart failure with preserved ejection fraction (HFpEF) and in heart failure with mildly reduced ejection fraction (HFmrEF). OBJECTIVES: This study sought to describe AF burden and its clinical impact among individuals with HFpEF and HFmrEF who participated in a randomized clinical trial of atrial shunt therapy (REDUCE LAP-HF II [A Study to Evaluate the Corvia Medical, Inc IASD System II to Reduce Elevated Left Atrial Pressure in Patients with Heart Failure]) and to evaluate the effect of atrial shunt therapy on AF burden. METHODS: Study investigators characterized AF burden among patients in the REDUCE LAP-HF II trial by using ambulatory cardiac patch monitoring at baseline (median patch wear time, 6 days) and over a 12-month follow-up (median patch wear time, 125 days). The investigators determined the association of baseline AF burden with long-term clinical events and examined the effect of atrial shunt therapy on AF burden over time. RESULTS: Among 367 patients with cardiac monitoring data at baseline and follow-up, 194 (53%) had a history of AF or atrial flutter (AFL), and median baseline AF burden was 0.012% (IQR: 0%-1.3%). After multivariable adjustment, baseline AF burden ≥0.012% was significantly associated with heart failure (HF) events (HR: 2.00; 95% CI: 1.17-3.44; P = 0.01) both with and without a history of AF or AFL (P for interaction = 0.68). Adjustment for left atrial reservoir strain attenuated the baseline AF burden-HF event association (HR: 1.71; 95% CI: 0.93-3.14; P = 0.08). Of the 367 patients, 141 (38%) had patch-detected AF during follow-up without a history of AF or AFL. Atrial shunt therapy did not change AF incidence or burden during follow-up. CONCLUSIONS: In HFpEF and HFmrEF, nearly 40% of patients have subclinical AF by 1 year. Baseline AF burden, even at low levels, is associated with HF events. Atrial shunt therapy does not affect AF incidence or burden. (A Study to Evaluate the Corvia Medical, Inc IASD System II to Reduce Elevated Left Atrial Pressure in Patients with Heart Failure [REDUCE LAP-HF II]; NCT03088033).