Six-month electrical performance of the first dual-chamber leadless pacemaker.

BACKGROUND: The first dual-chamber leadless pacemaker (DC-LP) system consists of 2 separate atrial and ventricular devices that communicate to maintain synchronous atrioventricular pacing and sensing. The initial safety and efficacy were previously reported. OBJECTIVE: The purpose of this study was to evaluate the chronic electrical performance of the DC-LP system. METHODS: Patients meeting standard dual-chamber pacing indications were enrolled and implanted with the DC-LP system (Aveir DR, Abbott), including right atrial and ventricular helix-fixation LPs (atrial leadless pacemaker [ALP], ventricular leadless pacemaker [VLP]). Pacing capture threshold, sensed amplitude, and pacing impedance were collected using the device programmer at prespecified timepoints from 0-6 months postimplant. RESULTS: De novo devices were successfully implanted in 381 patients with complete 6-month data (62% male; age 69 ± 14 years; weight 82 ± 20 kg; 65% sinus nodal dysfunction, 30% atrioventricular block). ALPs were implanted predominantly in the right atrial appendage anterior base and VLPs primarily at the mid-to-apical right ventricular septum. From implant to 1 month, pacing capture thresholds (0.4-ms pulse width) improved in both ALPs (2.4 ± 1.5 V to 0.8 ± 0.8 V; P <.001) and VLPs (0.8 ± 0.6 V to 0.6 ± 0.4 V; P <.001). Sensed amplitudes improved in both ALPs (1.8 ± 1.3 mV to 3.4 ± 1.9 mV; P <.001) and VLPs (8.8 ± 4.0 mV to 11.7 ± 4.2 mV; P <.001). Impedances were stable in ALPs (334 ± 68 Ω to 329 ± 52 Ω; P = .17) and reduced in VLPs (789 ± 351 Ω to 646 ± 190 Ω; P <.001). Electrical measurements remained relatively stable from 1-6 months postimplant. No differences in electrical metrics were observed among ALP or VLP implant locations. CONCLUSION: This first in-human evaluation of the new dual-chamber leadless pacemaker system demonstrated reliable electrical performance throughout the initial 6-month evaluation period.

Predictive value of the PRAETORIAN score for defibrillation test success in patients with subcutaneous ICD: A subanalysis of the PRAETORIAN-DFT trial.

BACKGROUND: The PRAETORIAN score estimates the risk of failure of subcutaneous implantable cardioverter-defibrillator (S-ICD) therapy by using generator and lead positioning on bidirectional chest radiographs. The PRospective randomized compArative trial of subcutanEous implanTable cardiOverter-defibrillatoR ImplANtation with and without DeFibrillation Testing (PRAETORIAN-DFT) investigates whether PRAETORIAN score calculation is noninferior to defibrillation testing (DFT) with regard to first shock efficacy in spontaneous events. OBJECTIVE: This prespecified subanalysis assessed the predictive value of the PRAETORIAN score for defibrillation success in induced ventricular arrhythmias. METHODS: This multicenter investigator-initiated trial randomized 965 patients between DFT and PRAETORIAN score calculation after de novo S-ICD implantation. Successful DFT was defined as conversion of induced ventricular arrhythmia in <5 seconds from shock delivery within 2 attempts. Bidirectional chest radiographs were obtained after implantation. The predictive value of the PRAETORIAN score for DFT success was calculated for patients in the DFT arm. RESULTS: In total, 482 patients were randomized to undergo DFT. Of these patients, 457 (95%) underwent DFT according to protocol, of whom 445 (97%) had successful DFT and 12 (3%) had failed DFT. A PRAETORIAN score of ≥90 had a positive predictive value of 25% for failed DFT, and a PRAETORIAN score of <90 had a negative predictive value of 99% for successful DFT. A PRAETORIAN score of ≥90 was the strongest independent predictor for failed DFT (odds ratio 33.77; confidence interval 6.13-279.95; P < .001). CONCLUSION: A PRAETORIAN score of <90 serves as a reliable indicator for DFT success in patients with S-ICD, and a PRAETORIAN score of ≥90 is a strong predictor for DFT failure.

Position paper on sustainability in cardiac pacing and electrophysiology from the Working Group of Cardiac Pacing and Electrophysiology of the French Society of Cardiology.

Sustainability in healthcare, particularly within the domain of cardiac electrophysiology, assumes paramount importance for the near future. The escalating environmental constraints encountered necessitate a proactive approach. This position paper aims to raise awareness among physicians, spark critical inquiry and identify potential solutions to enhance the sustainability of our practice. Reprocessing of single-use medical devices has emerged as a potential solution to mitigate the environmental impact of electrophysiology procedures, while also offering economic advantages. However, reprocessing remains unauthorized in certain countries. In regions where it is possible, stringent regulatory standards must be adhered to, to ensure patient safety. It is essential that healthcare professionals, policymakers and manufacturers collaborate to drive innovation, explore sustainable practices and ensure that patient care remains uncompromised in the face of environmental challenges. Ambitious national/international programmes of disease prevention should be the cornerstone of the strategy. It is equally vital to implement immediate actions, as delineated in this position paper, to bring about tangible change quickly.

Outcomes Associated With Left Atrial Appendage Occlusion Via Implanted Device in Atrial Fibrillation.

OBJECTIVE: To compare outcomes after left atrial appendage occlusion (LAAO) via implanted device vs no LAAO in a matched cohort of patients with atrial fibrillation (AF). METHODS: This longitudinal retrospective cohort study was based on the national database covering hospital care for the entire French population. Adults (≥18 years of age) who had been hospitalized with AF (January 1, 2015, to January 1, 2020) who underwent LAAO were identified. Propensity score matching was used to control for potential confounders of the treatment-outcome relationship. The primary outcome was a composite of ischemic stroke, major bleeding, or all-cause death during follow-up. RESULTS: After propensity score matching, 1216 patients with AF who were treated with LAAO were matched with 1216 controls (patients AF who were not treated with LAAO). Mean follow-up was 14.5 months (median, 13 months; IQR, 7-21 months). Patients with LAAO had a lower risk of the composite outcome (HR, 0.48; 95% CI, 0.42 to 0.55). Total events (309 for LAAO vs 640 for controls) and event rates (23.3% vs 44.0%/year, respectively) were lower for LAAO, driven primarily by a decreased risk of all-cause death (HR, 0.39; 95% CI, 0.33 to 0.46; P<.0001), whereas ischemic stroke risk was higher (HR, 1.75; 95% CI, 1.17 to 2.64). Significant interactions were observed in subgroups with a history of ischemic stroke (P<.001) and of bleeding (P=.002). CONCLUSION: Among AF patients at high bleeding risk, our nationwide study highlights a high risk of clinical events during follow-up. LAAO appeared less effective than no LAAO in preventing stroke but more effective in preventing death. Left atrial appendage occlusion is particularly effective in patients with previous ischemic stroke or any episode of bleeding.

Pre-emptive treatment of heart failure exacerbations in patients managed with the HeartLogic™ algorithm.

AIMS: Heart failure (HF) is a chronic disease affecting 64 million people worldwide and places a severe burden on society because of its mortality, numerous re-hospitalizations and associated costs. HeartLogic™ is an algorithm programmed into implanted devices incorporating several biometric parameters which aims to predict HF episodes. It provides an index which can be monitored remotely, allowing pre-emptive treatment of congestion to prevent acute decompensation. We aim to assess the impact and security of pre-emptive HF management, guided by the HeartLogic™ index. METHODS AND RESULTS: The HeartLogic™ France Cohort Study is an investigator-initiated, prospective, multi-centre, non-randomized study. Three hundred ten patients with a history of HF (left ventricular ejection fraction ≤40%; or at least one episode of clinical HF with elevated NT-proBNP ≥450 ng/L) and implanted with a cardioverter defibrillator enabling HeartLogic™ index calculation will be included across 10 French centres. The HeartLogic™ index will be monitored remotely for 12 months and in the event of a HeartLogic™ index ≥16, the local investigator will contact the patient for assessment and adjust HF treatment as necessary. The primary endpoint is unscheduled hospitalization for HF. Secondary endpoints are all-cause mortality, cardiovascular death, HF-related death, unscheduled hospitalizations for ventricular or atrial arrhythmia and HeartLogic™ index evolution over time. Blood samples will be collected for biobanking, and quality of life will be assessed. Finally, the safety of a HeartLogic™-triggered strategy for initiating or increasing diuretic therapy will be assessed. A blind and independent committee will adjudicate the events. CONCLUSIONS: The HeartLogic™ France Cohort Study will provide robust real-world data in a cohort of HF patients managed with the HeartLogic™ algorithm allowing pre-emptive treatment of heart failure exacerbations.

Type 3 long QT syndrome: Is the effectiveness of treatment with beta-blockers population-specific?

BACKGROUND: The efficacy of beta-blocker treatment in type 3 long QT syndrome (LQT3) remains debated. OBJECTIVES: The purpose of this study was to test the hypothesis that beta-blocker use is associated with cardiac events (CEs) in a French cohort of LQT3 patients. METHODS: All patients with a likely pathogenic/pathogenic variant in the SCN5A gene (linked to LQT3) were included and followed-up. Documented ventricular tachycardia/ventricular fibrillation, torsades de pointes, aborted cardiac arrest, sudden death, and appropriate shocks were considered as severe cardiac events (SCEs). CEs also included syncope. RESULTS: We included 147 patients from 54 families carrying 23 variants. Six of the patients developed symptoms before the age of 1 year and were analyzed separately. The 141 remaining patients (52.5% male; median age at diagnosis 24.0 years) were followed-up for a median of 11 years. The probabilities of a CE and an SCE from birth to the age of 40 were 20.5% and 9.9%, respectively. QTc prolongation (hazard ratio [HR] 1.12 [1.0-1.2]; P = .005]) and proband status (HR 4.07 [1.9-8.9]; P <.001) were independently associated with the occurrence of CEs. Proband status (HR 8.13 [1.7-38.8]; P = .009) was found to be independently associated with SCEs, whereas QTc prolongation (HR 1.11 [1.0-1.3]; P = .108) did not reach statistical significance. The cumulative probability of the age at first CE/SCE was not lower in patients treated with a beta-blocker. CONCLUSION: In agreement with the literature, proband status and lengthened QTc were associated with a higher risk of CEs. Our data do not show a protective effect of beta-blocker treatment.

Left atrial appendage closure in very elderly patients in the French National Registry.

OBJECTIVE: Left atrial appendage closure (LAAC) is recommended to decrease the stroke risk in patients with atrial fibrillation and contraindications to anticoagulation. However, age-stratified data are scarce. The aim of this study was to provide information on the safety and efficacy of LAAC, with emphasis on the oldest patients. METHODS: A nationwide, prospective, multicentre, observational registry was established by 53 French cardiology centres in 2018-2021. The composite primary endpoint included ischaemic stroke, systemic embolism, and unexplained or cardiovascular death. Separate analyses were done in the groups <80 years and ≥80 years. RESULTS: Among the 1053 patients included, median age was 79.7 (73.6-84.3) years; 512 patients (48.6%) were aged ≥80 years. Procedure-related serious adverse events were non-significantly more common in octogenarians (7.0% vs 4.4% in patients aged <80 years, respectively; p=0.07). Despite a higher mean CHA2DS2-VASc score in octogenarians, the rate of thromboembolic events during the study was similar in both groups (3.0 vs 3.1/100 patient-years; p=0.85). By contrast, all-cause mortality was significantly higher in octogenarians (15.3 vs 10.1/100 patient-years, p<0.015), due to a higher rate of non-cardiovascular deaths (8.2 vs 4.9/100 patient-years, p=0.034). The rate of the primary endpoint was 8.1/100 patient-years overall with no statistically significant difference between age groups (9.4 and 7.0/100 patient-years; p=0.19). CONCLUSION: Despite a higher mean CHA2DS2-VASc score in octogenarians, the rate of thromboembolic events after LAAC in this age group was similar to that in patients aged <80 years. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03434015).

Information provision and follow-up of French patients with implantable cardioverter-defibrillators: The APODEC survey.

BACKGROUND: Implantable cardioverter-defibrillators reduce mortality, but the electric shocks delivered can impact the patient's quality of life. Patient education is an efficient way to reduce the stress related to both the device and the disease. AIMS: We assessed the evolution of knowledge and satisfaction of implantable cardioverter-defibrillator recipients regarding their cardiac disease, implantable cardioverter-defibrillator implantation, follow-up complications, remote monitoring and daily life recommendations. Quality of life, implantable cardioverter-defibrillator-related stress levels and remote monitoring benefits were also evaluated. METHODS: A self-administered questionnaire of 43 items was published on the French Association of Cardiac Electrical Device Wearers (APODEC) website and sent to registered patients. RESULTS: Overall, 330 patients completed the survey. Physicians were the patients' principal information source regarding their cardiac disease (86.7%) and implantable cardioverter-defibrillator (93.3%), and 90% looked for further information after the procedure, mainly on websites (78.8%). More than half of the patients were not sufficiently informed about implantable cardioverter-defibrillators before implantation (61.2%). In the patients' opinion, the best sources of further information were their physician (81.8%), patient associations (63.6%) and the Internet (45.8%). Although patient knowledge increased during follow-up, their knowledge could be improved regarding daily life with an implantable cardioverter-defibrillator (52.1%), remote monitoring (34.2%) and their cardiac disease (32.1%). Remote monitoring follow-up was used by 92.1% of patients and mostly improved their peace of mind (67.8%). Implantable cardioverter-defibrillator shocks were associated with major stress for patients receiving them (46.6%). CONCLUSION: These findings highlight the lack of information provided to implantable cardioverter-defibrillator recipients before implantation, a concerning issue to be addressed in the near future.

Filtering of remote monitoring alerts transmitted by cardiac implantable electronic devices and reclassification of atrial fibrillation events by a new algorithm.

Background: Cardiac implantable electronic devices (CIEDs) are an important means of atrial fibrillation (AF) detection. However, the AF burden measurements and notifications transmitted by CIEDs are not directly related to the clinical classification of paroxysmal, persistent, or permanent AF. Moreover, AF alerts are the most frequent form of notification, imposing a time-consuming review on caregivers. Objective: The purpose of this study was to compare the incidence of standard AF burden-related notifications in remotely monitored (RM) patients with the incidence of events detected after filtering by a new proprietary algorithm implementing the standard European Society of Cardiology classification of AF. Methods: Between 2017 and 2022, all RM patients with daily AF burden measurements available for ≥30 days and ≥1 AF burden-related alerts were enrolled at 68 medical centers. The incidence of CIED-transmitted alerts was compared to that of AF episodes detected by a new proprietary algorithm and classified as "first recorded episode of AF", "paroxysmal AF", "increased paroxysmal AF", "persistent AF", or "end of persistent AF back to paroxysmal AF or back to sinus rhythm." Results: Between January 2017 and September 2022, this retrospective study analyzed data from 4162 recipients of an Abbott, Biotronik, Boston Scientific, or Medtronic CIED, RM over mean follow-up of 605 ± 386 days. The algorithm broke down 67,883 AF burden-related alerts into 9728 (14.3%) clinically relevant AF events. Conclusion: A new AF alert algorithm successfully identified clinically significant AF events in RM CIED recipients and would markedly limit the total number of transmitted alerts that require review by caregivers.

Safety and success of transvenous lead extraction using excimer laser sheaths: a meta-analysis of over 1700 patients.

AIMS: While numerous studies have demonstrated favourable safety and efficacy of the excimer laser sheath for transvenous lead extraction (TLE) in smaller cohorts, comprehensive large-scale investigations with contemporary data remain scarce. This study aims to evaluate the safety and performance of laser-assisted TLE through a meta-analysis of contemporary data. METHODS AND RESULTS: A systematic literature search was conducted to identify articles that assessed the safety and performance of the spectranetics laser sheath (SLS) II and GlideLight Excimer laser sheaths in TLE procedures between 1 April 2016 and 31 March 2021. Safety outcomes included procedure-related death and major/minor complications. Performance outcomes included procedural and clinical success rates. A random-effects, inverse-variance-weighting meta-analysis was performed to obtain the weighted average of the evaluated outcomes. In total, 17 articles were identified and evaluated, including 1729 patients with 2887 leads. Each patient, on average, had 2.3 ± 0.3 leads with a dwell time of 7.9 ± 3.0 years. The TLE procedural successes rate was 96.8% [1440/1505; 95% CI: (94.9-98.2%)] per patient and 96.3% [1447/1501; 95% CI: (94.8-97.4%)] per lead, and the clinical success rate per patient was 98.3% [989/1010, 95% CI: (97.4-99.0%)]. The procedure-related death rate was 0.08% [7/1729, 95% CI: (0.00%, 0.34%)], with major and minor complication rates of 1.9% [41/1729; 95% CI: (1.2-2.8%)] and 1.9% [58/1729; 95% CI: (0.8-3.6%)], respectively. CONCLUSION: This meta-analysis demonstrated that excimer laser sheath-assisted TLE has high success and low procedural mortality rates. It provides clinicians with a reliable and valuable resource for extracting indwelling cardiac leads which require advanced extraction techniques.

Subcutaneous Implantable Cardioverter-Defibrillators in Patients With Congenital Heart Disease.

BACKGROUND: Very few data have been published on the use of subcutaneous implantable cardioverter-defibrillators (S-ICDs) in patients with congenital heart disease (CHD). OBJECTIVES: The aim of this study was to analyze outcomes associated with S-ICDs in patients with CHD. METHODS: This nationwide French cohort including all patients with an S-ICD was initiated in 2020 by the French Institute of Health and Medical Research. Characteristics at implantation and outcomes were analyzed in patients with CHD. RESULTS: From October 12, 2012, to December 31, 2019, among 4,924 patients receiving an S-ICD implant in 150 centers, 101 (2.1%) had CHD. Tetralogy of Fallot, univentricular heart, and dextro-transposition of the great arteries represented almost one-half of the population. Patients with CHD were significantly younger (age 37.1 ± 15.4 years vs 50.1 ± 14.9 years; P < 0.001), more frequently female (37.6% vs 23.0%; P < 0.001), more likely to receive an S-ICD for secondary prevention (72.3% vs 35.9%; P < 0.001), and less likely to have severe systolic dysfunction of the systemic ventricle (28.1% vs 53.1%; P < 0.001). Over a mean follow-up period of 1.9 years, 16 (15.8%) patients with CHD received at least 1 appropriate shock, with all shocks successfully terminating the ventricular arrhythmia. The crude risk of appropriate S-ICD shock was twice as high in patients with CHD compared with non-CHD patients (annual incidences of 9.0% vs 4.4%; HR: 2.1; 95% CI: 1.3-3.4); however, this association was no longer significant after propensity matching (especially considering S-ICD indication, P = 0.12). The burden of all complications (HR: 1.2; 95% CI: 0.7-2.1; P = 0.4) and inappropriate shocks (HR: 0.9; 95% CI: 0.4-2.0; P = 0.9) was comparable in both groups. CONCLUSIONS: In this nationwide study, patients with CHD represented 2% of all S-ICD implantations. Our findings emphasize the effectiveness and safety of S-ICD in this particularly high-risk population. (S-ICD French Cohort Study [HONEST]; NCT05302115).

Cardiac pacing and lead devices management: 25 years of research at EP Europace journal.

AIMS: Cardiac pacing represents a key element in the field of electrophysiology and the treatment of conduction diseases. Since the first issue published in 1999, EP Europace has significantly contributed to the development and dissemination of the research in this area. METHODS: In the last 25 years, there has been a continuous improvement of technologies and a great expansion of clinical indications making the field of cardiac pacing a fertile ground for research still today. Pacemaker technology has rapidly evolved, from the first external devices with limited longevity, passing through conventional transvenous pacemakers to leadless devices. Constant innovations in pacemaker size, longevity, pacing mode, algorithms, and remote monitoring highlight that the fascinating and exciting journey of cardiac pacing is not over yet. CONCLUSION: The aim of the present review is to provide the current 'state of the art' on cardiac pacing highlighting the most important contributions from the Journal in the field.

Heart transplantation as a rescue strategy for patients with refractory electrical storm.

AIMS: Heart transplantation (HT) can be proposed as a therapeutic strategy for patients with severe refractory electrical storm (ES). Data in the literature are scarce and based on case reports. We aimed at determining the characteristics and survival of patients transplanted for refractory ES. METHODS AND RESULTS: Patients registered on HT waiting list during the following days after ES and eventually transplanted, from 2010 to 2021, were retrospectively included in 11 French centres. The primary endpoint was in-hospital mortality. Forty-five patients were included [82% men; 55.0 (47.8-59.3) years old; 42.2% and 26.7% non-ischaemic dilated or ischaemic cardiomyopathies, respectively]. Among them, 42 (93.3%) received amiodarone, 29 received (64.4%) beta blockers, 19 (42.2%) required deep sedation, 22 had (48.9%) mechanical circulatory support, and 9 (20.0%) had radiofrequency catheter ablation. Twenty-two patients (62%) were in cardiogenic shock. Inscription on wait list and transplantation occurred 3.0 (1.0-5.0) days and 9.0 (4.0-14.0) days after ES onset, respectively. After transplantation, 20 patients (44.4%) needed immediate haemodynamic support by extracorporeal membrane oxygenation (ECMO). In-hospital mortality rate was 28.9%. Predictors of in-hospital mortality were serum creatinine/urea levels, need for immediate post-operative ECMO support, post-operative complications, and surgical re-interventions. One-year survival was 68.9%. CONCLUSION: Electrical storm is a rare indication of HT but may be lifesaving in those patients presenting intractable arrhythmias despite usual care. Most patients can be safely discharged from hospital, although post-operative mortality remains substantial in this context of emergency transplantation. Larger studies are warranted to precisely determine those patients at higher risk of in-hospital mortality.

A Dual-Chamber Leadless Pacemaker.

BACKGROUND: Single-chamber ventricular leadless pacemakers do not support atrial pacing or consistent atrioventricular synchrony. A dual-chamber leadless pacemaker system consisting of two devices implanted percutaneously, one in the right atrium and one in the right ventricle, would make leadless pacemaker therapy a treatment option for a wider range of indications. METHODS: We conducted a prospective, multicenter, single-group study to evaluate the safety and performance of a dual-chamber leadless pacemaker system. Patients with a conventional indication for dual-chamber pacing were eligible for participation. The primary safety end point was freedom from complications (i.e., device- or procedure-related serious adverse events) at 90 days. The first primary performance end point was a combination of adequate atrial capture threshold and sensing amplitude at 3 months. The second primary performance end point was at least 70% atrioventricular synchrony at 3 months while the patient was sitting. RESULTS: Among the 300 patients enrolled, 190 (63.3%) had sinus-node dysfunction and 100 (33.3%) had atrioventricular block as the primary pacing indication. The implantation procedure was successful (i.e., two functioning leadless pacemakers were implanted and had established implant-to-implant communication) in 295 patients (98.3%). A total of 35 device- or procedure-related serious adverse events occurred in 29 patients. The primary safety end point was met in 271 patients (90.3%; 95% confidence interval [CI], 87.0 to 93.7), which exceeded the performance goal of 78% (P<0.001). The first primary performance end point was met in 90.2% of the patients (95% CI, 86.8 to 93.6), which exceeded the performance goal of 82.5% (P<0.001). The mean (±SD) atrial capture threshold was 0.82±0.70 V, and the mean P-wave amplitude was 3.58±1.88 mV. Of the 21 patients (7%) with a P-wave amplitude of less than 1.0 mV, none required device revision for inadequate sensing. At least 70% atrioventricular synchrony was achieved in 97.3% of the patients (95% CI, 95.4 to 99.3), which exceeded the performance goal of 83% (P<0.001). CONCLUSIONS: The dual-chamber leadless pacemaker system met the primary safety end point and provided atrial pacing and reliable atrioventricular synchrony for 3 months after implantation. (Funded by Abbott Medical; Aveir DR i2i ClinicalTrials.gov number, NCT05252702.).

Conduction system pacing in France in 2022: A snapshot survey from the Working Group of Pacing and Electrophysiology of the French Society of Cardiology.

BACKGROUND: Conduction system pacing (CSP) is an emerging and promising approach for physiological ventricular pacing. While data from randomized controlled trials are scarce, use of His-bundle pacing (HBP) and left bundle branch area pacing (LBBAP) has increased in France. AIM: To perform a national snapshot survey for cardiac electrophysiologists to evaluate adoption of CSP in France. METHODS: An online survey, distributed to every senior cardiac electrophysiologist in France, was conducted in November 2022. RESULTS: A total of 120 electrophysiologists completed the survey. Eighty-three (69%) respondents reported experience in undertaking CSP procedures and 27 (23%) were planning to start performing CSP in the coming 2 years. The implantation techniques and criteria used for successful implantation differed significantly among operators. The most frequent indications for HBP and LBBAP were high-degree atrioventricular block with left ventricular ejection fraction (LVEF) < 40% (24 and 82%, respectively) or with LVEF ≥ 40% (27 and 74%, respectively), and after failure of a coronary sinus left ventricular lead (27 and 71%, respectively). The limitations respondents most frequently perceived when performing HBP were bad sensing/pacing parameters (45%), increased procedure duration (41%) and risk of lead dislodgement (30%). The most frequently perceived limitations to performing LBBAP were absence of guidelines or consensus (31%), lack of medical training (23%) and increased procedure duration (23%). CONCLUSIONS: Our national survey-based study supports wide adoption of CSP in France. CSP is currently used as a second-line approach for both antibradycardia and resynchronization indications, with important variations regarding implantation techniques and criteria for measuring success.

Amplified sinus-P-wave analysis predicts outcomes of cryoballoon ablation in patients with persistent and long-standing persistent atrial fibrillation: A multicentre study.

Introduction: Outcomes of catheter ablation for non-paroxysmal atrial fibrillation (AF) remain suboptimal. Non-invasive stratification of patients based on the presence of atrial cardiomyopathy (ACM) could allow to identify the best responders to pulmonary vein isolation (PVI). Methods: Observational multicentre retrospective study in patients undergoing cryoballoon-PVI for non-paroxysmal AF. The duration of amplified P-wave (APW) was measured from a digitally recorded 12-lead electrocardiogram during the procedure. If patients were in AF, direct-current cardioversion was performed to allow APW measurement in sinus rhythm. An APW cut-off of 150 ms was used to identify patients with significant ACM. We assessed freedom from arrhythmia recurrence at long-term follow-up in patients with APW ≥ 150 ms vs. APW < 150 ms. Results: We included 295 patients (mean age 62.3 ± 10.6), of whom 193 (65.4%) suffered from persistent AF and the remaining 102 (34.6%) from long-standing persistent AF. One-hundred-forty-two patients (50.2%) experienced arrhythmia recurrence during a mean follow-up of 793 ± 604 days. Patients with APW ≥ 150 ms had a significantly higher recurrence rate post ablation compared to those with APW < 150 ms (57.0% vs. 41.6%; log-rank p < 0.001). On a multivariable Cox-regression analysis, APW≥150 ms was the only independent predictor of arrhythmia recurrence post ablation (HR 2.03 CI95% 1.28-3.21; p = 0.002). Conclusion: APW duration predicts arrhythmia recurrence post cryoballoon-PVI in persistent and long-standing persistent AF. An APW cut-off of 150 ms allows to identify patients with significant ACM who have worse outcomes post PVI. Analysis of APW represents an easy, non-invasive and highly reproducible diagnostic tool which allows to identify patients who are the most likely to benefit from PVI-only approach.

Dynamic changes in nocturnal heart rate predict short-term cardiovascular events in patients using the wearable cardioverter-defibrillator: from the WEARIT-France cohort study.

AIMS: While elevated resting heart rate measured at a single point of time has been associated with cardiovascular outcomes, utility of continuous monitoring of nocturnal heart rate (NHR) has never been evaluated. We hypothesized that dynamic NHR changes may predict, at short term, impending cardiovascular events in patients equipped with a wearable cardioverter-defibrillator (WCD). METHODS AND RESULTS: The WEARIT-France prospective cohort study enrolled heart failure patients with WCD between 2014 and 2018. Night-time was defined as midnight to 7 a.m. NHR initial trajectories were classified into four categories based on mean NHR in the first week (High/Low) and NHR evolution over the second week (Up/Down) of WCD use. The primary endpoint was a composite of cardiovascular death and heart failure hospitalization. A total of 1013 [61 (interquartile range, IQR 53-68) years, 16% women, left ventricular ejection fraction 26% (IQR 22-30)] were included. During a median WCD wear duration of 68 (IQR 44-90) days, 58 patients (6%) experienced 69 events. After considering potential confounders, High-Up NHR trajectory was significantly associated with the primary endpoint compared to Low-Down [adjusted hazard ratio (HR) 6.08, 95% confidence interval (CI) 2.56-14.45, P < 0.001]. Additionally, a rise of >5 bpm in weekly average NHR from the preceding week was associated with 2.5 higher composite event risk (HR 2.51, 95% CI 1.22-5.18, P = 0.012) as well as total mortality (HR 11.21, 95% CI 3.55-35.37, P < 0.001) and cardiovascular hospitalization (HR 2.70, 95% CI 1.51-4.82, P < 0.001). CONCLUSION: Dynamic monitoring of NHR may allow timely identification of impending cardiovascular events, with the potential for 'pre-emptive' action. REGISTRATION NUMBER: Clinical Trials.gov Identifier: NCT03319160.

A leadless pacemaker in the real-world setting: Patient profile and performance over time.

Background: While prior Micra trials demonstrated a high implant success rate and favorable safety and efficacy results, changes in implant populations and safety over time is not well studied. The objective of this analysis was to report the performance of Micra in European and Middle Eastern patients and compare to the Micra Investigational Device Exemption (IDE) and Micra Post Approval Registry (PAR) studies. Methods: The prospective, single-arm Micra Acute Performance European and Middle Eastern (MAP EMEA) registry was designed to further study the performance of Micra in patients from EMEA. The primary endpoint was to characterize acute (30-day) major complications. Electrical performance was analyzed. The major complication rate through 12 months was compared with the IDE and PAR studies. Results: The MAP EMEA cohort (n = 928 patients) had an implant success rate of 99.9% and were followed for an average of 9.7 ± 6.5 months. Compared to prior studies, MAP EMEA patients were more likely to have undergone dialysis and have a condition which precluded the use of a transvenous pacemaker (p < .001). Within 30 days of implantation, the MAP EMEA cohort had a major complication rate of 2.59%. Mean pacing thresholds were low and stable through 12 months (0.61 ± 0.40 V at 0.24 ms at implant and 12 months). Through 12 months post-implantation, the major complication rate for MAP EMEA was not significantly different from IDE (p = .56) or PAR (p = .79). Conclusion: Despite patient differences over time, the Micra leadless pacemaker was implanted with a high success rate and low complication rate, in-line with prior reports.