Prognostic value of ventricular arrhythmia in early post-infarction left ventricular dysfunction: the French nationwide WICD-MI study.

BACKGROUND AND AIMS: Prophylactic implantable cardioverter-defibrillators (ICDs) are not recommended until left ventricular ejection fraction (LVEF) has been reassessed 40 to 90 days after an acute myocardial infarction. In the current therapeutic era, the prognosis of sustained ventricular arrhythmias (VAs) occurring during this early post-infarction phase (i.e. within 3 months of hospital discharge) has not yet been specifically evaluated in post-myocardial infarction patients with impaired LVEF. Such was the aim of this retrospective study. METHODS: Data analysis was based on a nationwide registry of 1032 consecutive patients with LVEF ≤ 35% after acute myocardial infarction who were implanted with an ICD after being prescribed a wearable cardioverter-defibrillator (WCD) for a period of 3 months upon discharge from hospital after the index infarction. RESULTS: ICDs were implanted either because a sustained VA occurred while on WCD (VA+/WCD, n = 72) or because LVEF remained ≤35% at the end of the early post-infarction phase (VA-/WCD, n = 960). The median follow-up was 30.9 months. Sustained VAs occurred within 1 year after ICD implantation in 22.2% and 3.5% of VA+/WCD and VA-/WCD patients, respectively (P < .0001). The adjusted multivariable analysis showed that sustained VAs while on WCD independently predicted recurrence of sustained VAs at 1 year (adjusted hazard ratio [HR] 6.91; 95% confidence interval [CI] 3.73-12.81; P < .0001) and at the end of follow-up (adjusted HR 3.86; 95% CI 2.37-6.30; P < .0001) as well as 1-year mortality (adjusted HR 2.86; 95% CI 1.28-6.39; P = .012). CONCLUSIONS: In patients with LVEF ≤ 35%, sustained VA during the early post-infarction phase is predictive of recurrent sustained VAs and 1-year mortality.

Personalized screening before subcutaneous cardioverter-defibrillator implantation: Usefulness and outcomes in clinical practice-the S-ICD screening SIS prospective study.

BACKGROUND: Electrocardiographic screening before subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation is unsuccessful in around 10% of cases. A personalized screening method, by slightly moving the electrodes, to obtain a better R/T ratio has been described to overcome traditional screening failure. OBJECTIVE: The objectives of the SIS study were to assess to what extent a personalized screening method improves eligibility for S-ICD implantation and to evaluate the inappropriate shock rate after such screening success. METHODS: All consecutive patients eligible for an S-ICD implantation were prospectively recruited across 20 French centers between December 2019 and January 2022. In case of traditional screening failure, patients received a second personalized screening. If at least 1 vector was positive, the personalized screening was considered successful, and the patient was eligible for implantation. RESULTS: The study included 474 patients (mean age, 50.4 ± 14.1 years; 77.4% men). Traditional screening was successful in 456 (96.2%) cases. This figure rose to 98.3% (n = 466; P = .002) when personalized screening was performed. All patients implanted after successful personalized screening had correct signal detection on initial device interrogation. Nevertheless, after 1-year follow-up, 3 of the 7 patients (43%) implanted with personalized screening experienced inappropriate shock vs 18 of the 427 patients (4.2%) with traditional screening and S-ICD implantation (P = .003). CONCLUSION: Traditional S-ICD screening was successful in our study in a high proportion of patients. Considering the small improvement in success of screening and a higher rate of inappropriate shock, a strategy of personalized screening cannot be routinely recommended. CLINICALTRIALS: gov identifier: NCT04101253.

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.

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).

A randomized controlled trial of the intraoperative use of noninvasive ventilation versus supplemental oxygen by face mask for procedural sedation in an electrophysiology laboratory.

PURPOSE: The efficacy of noninvasive ventilation (NIV) during procedures that require sedation and analgesia has not been established. We evaluated whether NIV reduces the incidence of respiratory events. METHODS: In this randomized controlled trial, we included 195 patients with an American Society of Anesthesiologists Physical Status of III or IV during electrophysiology laboratory procedures. We compared NIV with face mask oxygen therapy for patients under sedation. The primary outcome was the incidence of respiratory events determined by a computer-driven blinded analysis and defined by hypoxemia (peripheral oxygen saturation < 90%) or apnea/hypopnea (absence of breathing for 20 sec on capnography). Secondary outcomes included hemodynamic variables, sedation, patient safety (composite scores of major or minor adverse events), and adverse outcomes at day 7. RESULTS: A respiratory event occurred in 89/98 (95%) patients in the NIV group and in 69/97 (73%) patients with face masks (risk ratio [RR], 1.29; 95% confidence interval [CI], 1.13 to 1.47; P < 0.001). Hypoxemia occurred in 40 (42%) patients in the NIV group and in 33 (34%) patients with face masks (RR, 1.21; 95% CI, 0.84 to 1.74; P = 0.30). Apnea/hypopnea occurred in 83 patients (92%) in the NIV group vs 65 patients (70%) with face masks (RR, 1.32; 95% CI, 1.14 to 1.53; P < 0.001). Hemodynamic variables, sedation, major or minor safety events, and patient outcomes were not different between the groups. CONCLUSIONS: Respiratory events were more frequent among patients receiving NIV without any safety or outcome impairment. These results do not support the routine use of NIV intraoperatively. STUDY REGISTRATION: ClinicalTrials.gov (NCT02779998); registered 4 November 2015.

RéSUMé: OBJECTIF: L'efficacité de la ventilation non invasive (VNI) pendant les interventions nécessitant une sédation et une analgésie n'a pas été établie. Nous avons évalué si la VNI réduisait l'incidence des complications respiratoires. MéTHODE: Dans cette étude randomisée contrôlée, nous avons inclus 195 patient·es de statut physique III ou IV selon l'American Society of Anesthesiologists pendant des interventions en laboratoire d'électrophysiologie. Nous avons comparé la VNI à l'oxygénothérapie par masque facial pour les patient·es sous sédation. Le critère d'évaluation principal était l'incidence des complications respiratoires déterminée par une analyse en aveugle assistée par ordinateur et définie par une hypoxémie (saturation périphérique en oxygène < 90 %) ou une apnée/hypopnée (absence de respiration pendant 20 secondes à la capnographie). Les critères d'évaluation secondaires comprenaient les variables hémodynamiques, la sédation, la sécurité des patient·es (scores composites des événements indésirables majeurs ou mineurs) et les issues indésirables au jour 7. RéSULTATS: Un événement respiratoire est survenu chez 89/98 (95 %) patient·es du groupe VNI et chez 69/97 (73 %) patient·es ayant un masque facial (risque relatif [RR], 1,29; intervalle de confiance [IC] à 95 %, 1,13 à 1,47; P < 0,001). Une hypoxémie est survenue chez 40 (42 %) patient·es du groupe VNI et chez 33 (34 %) patient·es ayant un masque facial (RR, 1,21 ; IC à 95 %, 0,84 à 1,74; P = 0,30). Une hypoxémie est survenue chez 40 (42 %) patient·es du groupe VNI et chez 33 (34 %) patient·es ayant un masque facial (RR, 1,21; IC 95 %, 0,84 à 1,74; P = 0,30). Les variables hémodynamiques, la sédation, les événements de sécurité majeurs ou mineurs et les issues pour les patient·es n'étaient pas différents entre les groupes. CONCLUSION: Les complications respiratoires étaient plus fréquentes chez les patient·es recevant une VNI sans aucun impact sur la sécurité ou les issues. Ces résultats n'appuient pas l'utilisation systématique de la VNI en peropératoire. ENREGISTREMENT DE L'éTUDE: ClinicalTrials.gov (NCT02779998); enregistrée le 4 novembre 2015.

Outcomes after cryoballoon ablation of paroxysmal atrial fibrillation with the PolarX or the Arctic Front Advance Pro: a prospective multicentre experience.

AIMS: The aim of this study was to compare procedural efficacy and safety, including 1-year freedom from AF recurrence, between the novel cryoballoon system PolarX (Boston Scientific) and the Arctic Front Advance Pro (AFA-Pro) (Medtronic), in patients with paroxysmal AF undergoing PVI. METHODS AND RESULTS: This multicentre prospective observational study included 267 consecutive patients undergoing a first cryoablation procedure for paroxysmal AF (137 PolarX, 130 AFA-Pro). Kaplan-Meier curves with the log-rank test was used to compare the 1-year freedom from AF recurrence between both groups. Multivariate Cox model was performed to evaluate whether the type of procedure (PolarX vs. AFA-Pro) had an impact on the occurrence of AF recurrences after adjustment on potentially confounding factors. The PolarX reaches lower temperatures than the AFA-Pro (LSPV 52 ± 5, vs. 59 ± 6; LIPV 49 ± 6 vs. 56 ± 6; right superior pulmonary vein: 49 ± 6 vs. 57 ± 7; right inferior pulmonary vein: 52 ± 6 vs. 59 ± 6; P < 0.0001). A higher rate of transient phrenic nerve palsy was found in patients treated with the PolarX system (15% vs. 7%, P = 0.05). After a mean follow-up of 15 ± 5 months, 20 patients (15%) had recurrences in AFA-Pro group and 27 patients (19%) in PolarX group (P = 0.35). Based on survival analysis, no significant difference was observed between both groups with a 12-month free of recurrence survival of 91.2% (85.1-95.4%) vs. 83.7% (76.0%-89.1%) (log-rank test P = 0.11). In multivariate Cox model hazard ratio of recurrence for PolarX vs. AFA-Pro was not significant [HR = 1.6 (0.9-2.8), P = 0.12]. CONCLUSION: PolarX and AFA-Pro have comparable efficacy and safety profiles for pulmonary veins isolation in paroxysmal atrial fibrillation.

Severe acute kidney injury related to haemolysis after pulsed field ablation for atrial fibrillation.

AIMS: Pulsed field ablation (PFA) has been proposed as a novel alternative to radiofrequency (RF) and cryoablation in the treatment of atrial fibrillation (AF). Following the occurrence of two cases of acute kidney injury (AKI) secondary to haemolysis after a PFA procedure, we evaluated haemolysis in a cohort of consecutive patients. METHODS AND RESULTS: Two cases of AKI occurred in last May and June 2023. AKI was secondary to acute and severe haemolysis after a PFA procedure. From June 2023, a total of 68 consecutive patients (64.3 ± 10.5 years) undergoing AF ablation with PFA were enrolled in the study. All patients had a blood sample the day after the procedure for the assessment of haemolysis indicators. The pentaspline PFA catheter was used with a total number of median applications of 64 (54; 76). Nineteen patients (28%) showed significantly depleted haptoglobin levels (<0.04 g/L). A significant inverse correlation was found between the plasma level of haptoglobin and the total number of applications. Two groups were compared: the haemolysis+ group (haptoglobin < 0.04 g/L) vs. the haemolysis- group. The total number of applications was significantly higher in the haemolysis+ group vs the haemolysis - group respectively 75 (62; 127) vs 62 (54; 71) P = 0.011. More than 70 applications seem to have better sensitivity and specificity to predict haemolysis. CONCLUSION: Intravascular haemolysis can occur after certain procedures of PFA. Acute kidney injury is a phenomenon that appears to be very rare after a PFA procedure. However, caution must be exercised in the number of applications to avoid severe haemolysis.

Feasibility of leadless left ventricular septal pacing with the WiSE-CRT system to target the left bundle branch area: A porcine model and multicenter patient experience.

BACKGROUND: The WiSE-CRT system delivers leadless endocardial left ventricular (LV) pacing to achieve cardiac resynchronization therapy. The electrode is conventionally placed on the lateral wall, but implanting on the LV septum may have advantages, including capture of the left bundle branch, and improved battery longevity owing to reduced distance from the transmitter. OBJECTIVE: The purpose of this study was to assess the feasibility of leadless LV septal pacing via the WiSE-CRT system. METHODS: Two pigs underwent electrode implantation on the LV septum with subsequent anatomical and histological examination. Eight patients underwent implantation of the WiSE-CRT system with deployment of the electrode on the LV septum via an interatrial transseptal approach. RESULTS: Deployment of the electrode on the LV septum was successful in both animals. Histological examination demonstrated electrode tines in close proximity to Purkinje tissue. WiSE-CRT implantation with an LV septal electrode was successful in all patients. Biventricular capture was confirmed, with a significant reduction in QRS duration (187.1 ± 33.8 ms vs 149.5 ± 15.7 ms; P = .009). Temporary LV pacing achieved further QRS reduction (139.8 ± 12.4 ms), and in 4 patients the peak LV activation time in lead V5/V6 was <90 ms, suggesting left bundle branch capture. At early follow-up, the median LV pacing percentage was 98.5% and 5 patients (62.5%) improved symptomatically. The transmitter-to-electrode distance was lower than the distance to the lateral wall during acoustic window screening (8.8 ± 1.6 cm vs 11.9 ± 1.5 cm; P = .002). CONCLUSION: Leadless LV septal pacing with the WiSE-CRT system to target the left bundle branch appears feasible. Further study is required to assess the efficacy and safety of this technique.

Pre-implant predictors of inappropriate shocks with the third-generation subcutaneous implantable cardioverter defibrillator.

AIMS: Despite recent improvements, inappropriate shocks emitted by implanted subcutaneous implantable cardioverter defibrillators (S-ICDs) remain a challenge in 'real-life' practice. We aimed to study the pre-implant factors associated with inappropriate shocks for the latest generation of S-ICDs. METHODS AND RESULTS: Three-hundred patients implanted with the third-generation S-ICD system for primary or secondary prevention between January 2017 and March 2020 were included in this multicentre retrospective observational study. A follow-up of at least 6 months and pre-implant screening procedure data were mandatory for inclusion. During a mean follow-up of 22.8 (±11.4) months, 37 patients (12.3%) received appropriate S-ICD shock therapy, whereas 26 patients (8.7%) experienced inappropriate shocks (incidence 4.9 per 100 patient years). The total number of inappropriate shock episodes was 48, with nine patients experiencing multiple episodes. The causes of inappropriate shocks included supraventricular arrhythmias (34.6%) and cardiac (30.7%) or extra-cardiac noise (38.4%) oversensing. Using multivariate analysis, we explored the independent factors associated with inappropriate shocks. These were the availability of less than three sensing vectors during pre-implant screening [hazard ratio (HR), 0.33; 95% confidence interval (CI), 0.11-0.93; P = 0.035], low QRS/T wave ratio in Lead I (for a threshold <3; HR, 4.79; 95% CI, 2.00-11.49; P < 0.001), history of supraventricular tachycardia (HR, 8.67; 95% CI, 2.80-26.7; P < 0.001), and being overweight (body mass index > 25; HR, 2.66; 95% CI, 1.10-6.45; P = 0.03). CONCLUSION: Automatic pre-implant screening data are a useful quantitative predictor of inappropriate shocks. Electrocardiogram features should be taken into consideration along with other clinical factors to identify patients at high risk of inappropriate shocks.

Mitral valve perforation after left lateral accessory pathway ablation: a case report.

BACKGROUND: Radiofrequency catheter ablation is considered to be a relatively safe procedure. This is an unusual case report in which severe mitral regurgitation was occurred after left lateral accessory pathway radiofrequency catheter ablation. CASE PRESENTATION: A 15-year-old man without structural heart disease was referred for ablation of a left lateral accessory pathway. He was a rugby player who had lived with Wolff-Parkinson-White syndrome since 2017. In 2017, two failed extensive radiofrequency catheter ablations of a left lateral accessory pathway had been performed in another center. In June 2018, he underwent a third radiofrequency catheter ablation of a left lateral accessory pathway using an anterograde transseptal approach with an early recurrence one month later. A successful fourth procedure was performed in August 2018 using a retrograde aortic approach. Three months later, the patient presented to the hospital with atypical chest pain and dyspnea on exertion. Transthoracic echocardiography revealed severe mitral regurgitation caused by a perforation of the posterior leaflet. Given the symptoms and the severity of the mitral valve regurgitation, the decision was taken to proceed with surgical intervention. Posterior mitral leaflet perforation was confirmed intraoperatively. The patient underwent video-assisted mitral valve repair via Minithoracotomy approach. CONCLUSION: This case demonstrates a very rare complication of Wolff-Parkinson-White radiofrequency ablation.

Rise and fall of thyroid radiologic density during the time course of amiodarone-induced thyrotoxicosis.

Background and Objective: It has been reported recently in a cross sectional study that patients with amiodarone induced thyrotoxicosis (AIT) showed a 'white' thyroid on unenhanced computed tomography, due to intrathyroid iodine accumulation. However, the link between increase in thyroid radiologic density and amiodarone induced thyrotoxicosis remains unknown. We sought to analyze this link. Methods: We present the case of a 34-year-old patient with severe sarcoidosis-related hypertrophic cardiomyopathy who was followed with successive unenhanced CT scans integrated with FDG PET scans. After the first CT scans the patient, who initially had a normal thyroid function, was exposed to amiodarone during 23 months and developed AIT, very likely by thyroiditis (AIT type 2). There were no thyroid antibodies, no evidence of thyroid sarcoidosis on FDG PET scan, while thyroid sonogram showed a homogenous 22 ml moderate goiter with normal echogenicity and no nodules. Results: Analysis of the successive enhanced CT scans revealed that after initiation of amiodarone treatment, thyroid radiologic density steadily increased before detection of AIT, peaked after cessation of amiodarone and initiation of thyrotoxicosis treatment, before returning to normal as thyrotoxicosis receded. Thyroid volume also showed a moderate increase, peaking at the detection of thyrotoxicosis, before returning to normal. Conclusion: This case suggests that AIT is preceded by a very high intrathyroid iodine accumulation before the 'burst' of thyroiditis occurs and that measurements of thyroid gland radiological density might predict the development and remission of AIT.

Technical feasibility of leadless left bundle branch area pacing for cardiac resynchronization: a case series.

BACKGROUND: Left bundle branch area pacing (LBBAP) is a novel form of conduction system pacing which can reverse left bundle branch block and deliver cardiac resynchronization therapy (CRT). The WiSE-CRT system delivers leadless endocardial pacing with symptomatic and left ventricular (LV) remodelling improvements following intervention. We report the technical feasibility of delivering leadless LBBAP using the WiSE-CRT system. CASE SUMMARY: In Case 1, a 57-year-old male with ischaemic cardiomyopathy and complete heart block underwent implantation of the WiSE-CRT system, using a retrograde transaortic approach, after failed conventional CRT. Temporary left bundle stimulation from the LV septum achieved superior electrical resynchronization and equivalent haemodynamic response compared to endocardial pacing at the lateral LV wall. In Case 2, an 82-year-old gentleman with tachyarrhythmia-induced cardiomyopathy underwent WiSE-CRT implantation via a trans-septal inter-atrial approach, with the endocardial electrode successfully deployed in the LV septum. DISCUSSION: Here we report the first case of deployment of the WiSE-CRT endocardial electrode in the LV septum and demonstrate the technical feasibility of leadless LBBAP. Entirely leadless CRT is an attractive option for patients with venous access issues or recurrent lead complications and has previously been successful using the WiSE-CRT system and a leadless pacemaker in the right ventricle. Further studies are required to assess long-term efficacy and safety of leadless LBBAP.

European experience with a first totally leadless cardiac resynchronization therapy pacemaker system.

AIMS: Totally leadless cardiac resynchronization therapy (CRT) can be delivered with a combination of Micra and WiSE-CRT systems. We describe the technical feasibility and first insights into the safety and efficacy of this combination in European experience. METHODS AND RESULTS: Patients enrolled had indication for both Micra and WiSE-CRT systems because of heart failure related to high burden of pacing by a Micra necessitating system upgrade or inability to implant a conventional CRT system because of infectious or anatomical conditions. The endpoints of the study were technical success of WiSE-CRT implantation with right ventricle-synchonized CRT delivery, acute QRS duration reduction, and freedom from procedure-related major adverse events. All eight WiSE-CRT devices were able to detect the Micra pacing output and to be trained to deliver synchronous LV endocardial pacing. Acute QRS reduction following WiSE-CRT implantation was observed in all eight patients (mean QRS 204.38 ± 30.26 vs. 137.5 ± 24.75 mS, P = 0.012). Seven patients reached 6 months of follow-up. At 6 months after WiSE-CRT implantation, there was a significant increase in LV ejection fraction (28.43 ± 8.01% vs. 39.71 ± 11.89%; P = 0.018) but no evidence of LV reverse remodelling or improvement in New York Heart Association class. CONCLUSION: The Micra and the WiSE-CRT systems can successfully operate together to deliver total leadless CRT to a patient. Moreover, the WiSE-CRT system provides the only means to upgrade the large population of Micra patients to CRT capability without replacing the Micra. The range of application of this combination could broaden in the future with the upcoming developments of leadless cardiac pacing.

Atrial fibrillation detection by the subcutaneous defibrillator: real-world clinical performances and implications from a multicentre study.

AIMS: No data exist concerning the clinical performances of the subcutaneous implantable cardioverter-defibrillator (S-ICD) atrial fibrillation (AF) detection algorithm. We aimed to study the performances and implications of the latter in a 'real-world' setting. METHODS AND RESULTS: Between July 2017 and August 2019, 155 consecutive S-ICD recipients were included. Endpoint of the study was the incidence of de novo or recurrent AF using a combined on-site and remote-monitoring follow-up approach. After a mean follow-up of 13 ± 8 months, 2531 AF alerts were generated for 55 patients. A blinded analysis of the 1950 subcutaneous electrocardiograms available was performed. Among them 47% were true AF, 23% were premature atrial contractions or non-sustained AF, 29% were premature ventricular contractions or non-sustained ventricular tachycardia, and 1% were misdetection. Fourteen percent (21/155) patients had at least one correct diagnosis of AF by the S-ICD algorithm. One patient presented symptomatic paroxysmal AF not diagnosed by the S-ICD algorithm (false negative patient). Patient-based sensitivity, specificity, positive, and negative predictive values were respectively 95%, 74%, 38%, and 99%. Among patients with at least one correct diagnosis of AF, 38% (8/21) had subsequent clinical implications (anticoagulation initiation or rhythm control therapies). CONCLUSION: The S-ICD AF detection algorithm yields a high sensitivity for AF diagnosis. Low specificity and positive predictive value contribute to a high remote monitoring-notification workload and underline the necessity of a manual analysis. Atrial fibrillation diagnosis by the S-ICD AF detection algorithm might lead to significant therapeutic adjustments.

Subcutaneous Implantable Cardioverter-Defibrillator Lead Extraction: First Multicenter French Experience.

OBJECTIVES: The aim of this multicenter study was to characterize the efficacy and safety of subcutaneous implantable cardioverter-defibrillators (S-ICDs) lead extraction procedures. BACKGROUND: S-ICDs have been developed to limit lead-related complications inherent to transvenous ICD devices. To date, no study has specifically investigated the safety and feasibility of S-ICD lead extraction procedures. METHODS: Patients requiring S-ICD lead extraction between February 1, 2014, and February 28, 2019, were retrospectively included in 10 centers. The primary endpoint of the study was procedural success, defined as the removal of all the lead and lead material from the subcutaneous space. Secondary endpoints included procedural complications and the need for specific extraction tools. RESULTS: S-ICD lead extraction procedures were performed in 32 patients (mean age 45.7 ± 13.8 years, 75.0% men, 65.6% in primary prevention). The median time from S-ICD lead implantation was 9.3 months (5.4 to 17.5 months). The primary endpoint, that is, complete removal of the material, was achieved in 96.9% of the patients, and only 1 procedural failure occurred (3.1%). Simple traction of the S-ICD lead was successful in 19 patients (59.4%), whereas 3 patients (9.4%) needed an additional incision and 9 patients (28.1%) required mechanical sheath to remove lead adhesions around the coil. No procedure-related complications occurred. Patients with successful simple traction extraction were implanted more recently (7.1 months [2.8 to 12.2 months] vs. 16.5 months [7.5 to 20.8 months]; p = 0.04) and had less prior history of sternotomy (2 [10.5%] vs. 5 [38.5%] patients; p = 0.09). CONCLUSIONS: S-ICD lead extraction is an efficient and safe procedure, but may require some specific tools like mechanical sheath, specifically when fibrotic adhesions developed around the parasternal coil.

Subcutaneous implantable cardioverter defibrillator indication in prevention of sudden cardiac death in difficult clinical situations: A French expert position paper.

The introduction of a new technology always raises questions about its place compared with the reference technology. The use of an implantable cardioverter defibrillator to prevent sudden cardiac death is now a widely proven technique, with a clear statement of its indication in the guidelines. More recently, a subcutaneous implantable cardioverter defibrillator has been introduced, and appears to be an attractive technique as it removes the need to implant a lead inside the right ventricle to treat the patient, which should dramatically decrease the risk of complications over time. Currently, only one model of subcutaneous implantable cardioverter defibrillator is available on the market; its indications are the same as for transvenous implantable cardioverter defibrillators, except for patients who need stimulation because of conduction disorders or ventricular tachycardias that can potentially be treated effectively by antitachycardia pacing. The different technical characteristics of transvenous versus subcutaneous implantable cardioverter defibrillators therefore raise the question of which to choose in different clinical settings. The experts who participated in the preparation of this manuscript had three meetings, organized by the company Boston Scientific. Each expert prepared the draft of a section corresponding to a clinical situation. The choice between transvenous versus subcutaneous implantable cardioverter defibrillator was then voted on by all the experts. The results of the votes are presented in this manuscript, as it seemed important to us to show the disparities of opinion that can exist in certain situations. The votes were cast independently and anonymously.

Validation of an apnea and hypopnea detection algorithm implemented in implantable cardioverter defibrillators. The AIRLESS study.

Diagnosis of sleep apnea (SA) using simple tools has the potential to improve the efficacy of cardiac implants in the prevention of cardiac arrhythmias. The aim of the present study was to validate a transthoracic impedance sensor for SA diagnosis in patients with cardiac implants. We compared the apnea-hypopnea index (AHI) obtained from polysomnography (AHIPSG) with the AHI obtained from autoscoring algorithms of the ApneaScan implantable impedance respiration sensor (AHIAS) three months after implantation of cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D) devices. Twenty-five patients with indications for implantation of ICD or CRT-D (INCEPTA; Boston Scientific) (24 men, 59.9 ± 14.4 years; LVEF 30.3 ± 6.4%; body mass index 25.9 ± 4.2 kg/m²) were included. Mean AHI-PSG was 21.9 ± 19.1 events/hr. A significant correlation was found between AHIPSG and AHIAS especially for the most severe SA (Spearman correlation: 0.71, p < 0.001). Intraclass Correlation Coefficient (was in the expected range: 0.67, 95% CI: 0.39-0.84. The mean bias was 5.4 events per hour (mean AHI: 23.3 ± 14.6 versus 29.7 ± 13.7 for AHI-PSG and AHI-AS, respectively). An optimal cutoff value for the AHIAS at 30 events/h was obtained from the Receiver Operator Characteristic (ROC) curve analysis, which yielded a sensitivity of 100%, a specificity of 80%, PPV = 67%, NPV = 100%. Using an advanced algorithm for autoscoring of transthoracic impedance included in ICDs is reliable to identify SA and has the potential to improve the management of patients with cardiac implants.

Device-Related Thrombosis After Percutaneous Left Atrial Appendage Occlusion for Atrial Fibrillation.

BACKGROUND: Transcatheter left atrial appendage (LAA) occlusion is an alternative strategy for stroke prevention in patients with atrial fibrillation (AF). OBJECTIVES: This study sought to determine the incidence, predictors, and prognosis of thrombus formation on devices in patients with AF who were treated with LAA closure. METHODS: The study retrospectively analyzed data from patients treated with 2 LAA closure devices seen in 8 centers in France from February 2012 to January 2017. RESULTS: A total of 469 consecutive patients with AF underwent LAA closure (272 Watchman devices [Atritech, Boston Scientific, Natick, Massachusetts] and 197 Amplatzer devices [St. Jude Medical, Minneapolis, Minnesota]). Mean follow-up was 13 ± 13 months, during which 339 (72.3%) patients underwent LAA imaging at least once. There were 98 major adverse events (26 thrombi on devices, 19 ischemic strokes, 2 transient ischemic attacks, 18 major hemorrhages, 33 deaths) recorded in 89 patients. The incidence of device-related thrombus in patients with LAA imaging was 7.2% per year. Older age (hazard ratio [HR]: 1.07 per 1-year increase; 95% confidence interval [CI]: 1.01 to 1.14; p = 0.02) and history of stroke (HR: 3.68; 95% CI: 1.17 to 11.62; p = 0.03) were predictors of thrombus formation on the devices, whereas dual antiplatelet therapy (HR: 0.10; 95% CI: 0.01 to 0.76; p = 0.03) and oral anticoagulation at discharge (HR: 0.26; 95% CI: 0.09 to 0.77; p = 0.02) were protective factors. Thrombus on the device (HR: 4.39; 95% CI: 1.05 to 18.43; p = 0.04) and vascular disease (HR: 5.03; 95% CI: 1.39 to 18.23; p = 0.01) were independent predictors of ischemic strokes and transient ischemic attacks during follow-up. CONCLUSIONS: Thrombus formation on the device is not uncommon in patients with AF who are treated by LAA closure. Such events are strongly associated with a higher risk of ischemic stroke during follow-up. (REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion [RELEXAO]; NCT03279406).