Recent progress in combination therapy of oncolytic vaccinia virus.

In recent years, oncolytic viruses have emerged as promising agents for treating various cancers. An oncolytic virus is a non-pathogenic virus that, due to genetic manipulation, tends to replicate in and cause lysis of cancerous cells while leaving healthy cells unaffected. Among these viruses, vaccinia virus is an attractive platform for use as an oncolytic platform due to its 190 Kb genome with a high capacity for encoding therapeutic payloads. Combining oncolytic VV therapy with other conventional cancer treatments has been shown to be synergistic and more effective than monotherapies. Additionally, OVV can be used as a vector to deliver therapeutic payloads, alone or in combination with other treatments, to increase overall efficacy. Here, we present a comprehensive analysis of preclinical and clinical studies that have evaluated the efficacy of oncolytic vaccinia viruses in cancer immunotherapy. We discuss the outcomes of these studies, including tumor regression rates, overall survival benefits, and long-term responses. Moreover, we provide insights into the challenges and limitations associated with oncolytic vaccinia virus- based therapies, including immune evasion mechanisms, potential toxicities, and the development of resistance.

Is COVID-19 Infection a Multiorganic Disease? Focus on Extrapulmonary Involvement of SARS-CoV-2.

First described in December 2019 in Wuhan (China), COVID-19 disease rapidly spread worldwide, constituting the biggest pandemic in the last 100 years. Even if SARS-CoV-2, the agent responsible for COVID-19, is mainly associated with pulmonary injury, evidence is growing that this virus can affect many organs, including the heart and vascular endothelial cells, and cause haemostasis, CNS, and kidney and gastrointestinal tract abnormalities that can impact in the disease course and prognosis. In fact, COVID-19 may affect almost all the organs. Hence, SARS-CoV-2 is essentially a systemic infection that can present a large number of clinical manifestations, and it is variable in distribution and severity, which means it is potentially life-threatening. The goal of this comprehensive review paper in the series is to give an overview of non-pulmonary involvement in COVID-19, with a special focus on underlying pathophysiological mechanisms and clinical presentation.

Value of HAVOC and Brown ESUS-AF scores for atrial fibrillation on implantable cardiac monitors after embolic stroke of undetermined source.

OBJECTIVES: Up to 20 % of ischemic strokes are associated with overt atrial fibrillation (AF). Furthermore, silent AF was detected by an implantable cardiac monitor (ICM) in 1 in 3 cryptogenic strokes in the CRYSTAL AF study. An ESC position paper has suggested a HAVOC score ≥ 4 or a Brown ESUS-AF score ≥ 2 as criteria for ICM implantation after cryptogenic stroke, but neither of these criteria has been developed or validated in ICM populations. We assessed the performance of HAVOC and Brown ESUS-AF scores in a cohort of ICM patients implanted after embolic stroke of undetermined source (ESUS). METHODS: All patients implanted with an ICM for ESUS between February 2016 and February 2022 at two French University Hospitals were retrospectively included. Demographic data, cardiovascular risk factors, and clinical and biological data were collected after a review of electronic medical records. HAVOC and Brown ESUS-AF scores were calculated for all patients. FINDINGS: Among the 384 patients included, 106 (27 %) developed AF during a mean follow-up of 33 months. The scores performances for predicting AF during follow-up were: HAVOC= AUC: 68.5 %, C-Index: 0.662, and Brown ESUS-AF=AUC: 72.9 %, C-index 0.712. Compared with the CHA2DS2-VASc score, only the Brown ESUS-AF score showed significant improvement in NRI/IDI. Furthermore, classifying patients according to the suggested HAVOC and Brown ESUS-AF thresholds, only 24 % and 31 % of the cohort, respectively, would have received an ICM, and 58 (55 %) and 47 (44 %) of the AF patients, respectively, would not have been implanted with an ICM. CONCLUSION: HAVOC and Brown ESUS-AF scores showed close and moderate performance in predicting AF on ICM after cryptogenic stroke, with a significant lack of sensitivity. Specific risk scores should be developed and validated in large ICM cohorts.

Cardiac stereotactic radiation therapy for refractory ventricular arrhythmias in patients with left ventricular assist devices.

Left ventricular assist device (LVAD) implantation is an established treatment for patients with advanced heart failure refractory to medical therapy. However, the incidence of ventricular arrhythmias (VAs) is high in this population, both in the acute and delayed phases after implantation. About one-third of patients implanted with an LVAD will experience sustained VAs, predisposing these patients to worse outcomes and complicating patient management. The combination of pre-existing myocardial substrate and complex electrical remodeling after LVAD implantation account for the high incidence of VAs observed in this population. LVAD patients presenting VAs refractory to antiarrhythmic therapy and catheter ablation procedures are not rare. In such patients, treatment options are extremely limited. Stereotactic body radiation therapy (SBRT) is a technique that delivers precise and high doses of radiation to highly defined targets, reducing exposure to adjacent normal tissue. Cardiac SBRT has recently emerged as a promising alternative with a growing number of case series reporting the effectiveness of the technique in reducing the VA burden in patients with arrhythmias refractory to conventional therapies. The safety profile of cardiac SBRT also appears favorable, even though the current clinical experience remains limited. The use of cardiac SBRT for the treatment of refractory VAs in patients implanted with an LVAD are even more scarce. This review summarizes the clinical experience of cardiac SBRT in LVAD patients and describes technical considerations related to the implementation of the SBRT procedure in the presence of an LVAD.

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).

Distribution of atrial cardiomyopathy markers and association with atrial fibrillation detected after ischaemic stroke in the SAFAS study.

BACKGROUND: Atrial cardiomyopathy (AC) is an emerging concept explaining the pathophysiology of cardioembolic strokes in absence of atrial fibrillation (AF). A definition based on the presence of electrical abnormality (P-wave terminal force in lead V1 (PTFV1) >5000 µV×ms), N-Terminal pro-B-type natriuretic peptide (NT pro BNP) >250 pg/mL and/or indexed left atrial diameter (LADI) >3 cm/m² is currently tested in the ARCADIA (AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenic stroke) trial. We set out to estimate the prevalence of AC as defined in the ARCADIA trial, its determinants and its association with AF detected after stroke (AFDAS). METHODS: Stepwise screening for silent Atrial Fibrillation After Stroke (SAFAS) study prospectively included 240 ischaemic stroke patients. AC markers were complete for 192 of them and 9 were not included in this analysis because AF had been diagnosed on admission. RESULTS: A total of 183 patients were analysed, of whom 57% (104 patients) met the AC criteria (79 NT-proBNP, 47 PTFV1, 4 LADI). In the multivariate logistic regression, C reactive protein >3 mg/L (OR (95% CI) 2.60 (1.30 to 5.21), p=0.007) and age (OR (95% CI) 1.07 (1.04 to 1.10), p<0.001) were found to be independently associated with AC. After 6 months of follow-up, AFDAS was detected in 33% of AC patients and in 14% of the remaining ones (p=0.003). However, AC was not independently associated with AFDAS, contrary to left atrial volume index (>34 mL/m2, OR 2.35 (CI 1.09 to 5.06) p=0029). CONCLUSION: AC as defined in ARCADIA is mostly based on NT pro BNP elevation (76% of patients) and is associated with age and inflammation. Moreover, AC was not independently associated with AFDAS at follow-up. The ARCADIA trial, which compares aspirin to apixaban in patients with embolic strokes of undetermined source with AC markers and must, therefore be analysed in the light of these limitations. TRIAL REGISTRATION NUMBER: NCT03570060.

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).

Incidence and predictors of pacemaker implantation at follow-up after reversible high-degree sinus node dysfunction or atrioventricular block.

BACKGROUND: A pacemaker implantation is not indicated in cases of reversible high-degree symptomatic sinus node dysfunction (SND) and atrioventricular block (AVB). However, it remains uncertain whether these reversible automaticity/conduction disorders may recur in some patients at follow-up, in the absence of reversible cause. This retrospective study aimed to determine the incidence and predictive factors of permanent pacemaker (PPM) implantation at follow-up and after reversible high-degree SND/AVB. METHODS: Based on medical electronic files codes, we identified patients who were hospitalized in our cardiac intensive care unit between January 2003 and December 2020 due to reversible high-degree SND/AVB and who were discharged from the hospital alive and without PPM implantation. Acute myocardial infarction and post-cardiac surgery patients were excluded. We categorized the patients according to the need for PPM at follow-up due to non-reversible high-degree SND/AVB. RESULTS: Of the 93 patients included, 26 patients (28%) were readmitted for PPM implantation at follow-up after hospital discharge. Among baseline characteristics, compared with patients who did not have high-degree SND/AVB recurrence, those who had subsequent PPM implantation had less frequent previous hypertension (70% vs. 46%, p = .031). Regarding the initial causes of reversible SND/AVB, isolated hyperkalemia was found more often in the patients readmitted for PPM (19% vs. 3% vs. p = .017). Moreover, recurrence of high-degree SND/AVB was significantly associated with the presence of intraventricular conduction disorders (either bundle branch block or left bundle branch hemiblock) on ECG at discharge (36% in patients without PPM vs. 68% in PPM patients, p = .012). CONCLUSION: Almost one third of the patients discharged alive from the hospital after a reversible high-degree SND/AVB needed a pacemaker implantation at follow-up. Complete bundle branch block or left bundle branch hemiblock on discharge ECG after recovery of atrioventricular conduction and/or sinus automaticity was associated with a greater risk of recurrence leading to pacemaker implantation.

Efficiency and effectiveness of intensive multidisciplinary follow-up of patients with stroke/TIA or myocardial infarction compared to usual monitoring: protocol of a pragmatic randomised clinical trial. DiVa (Dijon vascular) study.

INTRODUCTION: The ongoing ageing population is associated with an increase in the number of patients suffering a stroke, transient ischaemic attack (TIA) or myocardial infarction (MI). In these patients, implementing secondary prevention is a critical challenge and new strategies need to be developed to close the gap between clinical practice and evidence-based recommendations. We describe the protocol of a randomised clinical trial that aims to evaluate the efficiency and effectiveness of an intensive multidisciplinary follow-up of patients compared with standard care. METHODS AND ANALYSIS: The DiVa study is a randomised, prospective, controlled, multicentre trial including patients >18 years old with a first or recurrent stroke (ischaemic or haemorrhagic) or TIA, or a type I or II MI, managed in one of the participating hospitals of the study area, with a survival expectancy >12 months. Patients will be randomised with an allocation ratio of 1:1 in two parallel groups: one group assigned to a multidisciplinary, nurse-based and pharmacist-based 2-year follow-up in association with general practitioners, neurologists and cardiologists versus one group with usual follow-up. In each group for each disease (stroke/TIA or MI), 430 patients will be enrolled (total of 1720 patients) over 3 years. The primary outcome will be the incremental cost-utility ratio at 24 months between intensive and standard follow-up in a society perspective. Secondary outcomes will include the incremental cost-utility ratio at 6 and 12 months, the incremental cost-effectiveness ratio at 24 months, reduction at 6, 12 and 24 months of the rates of death, unscheduled rehospitalisation and iatrogenic complications, changes in quality of life, net budgetary impact at 5 years of the intensive follow-up on the national health insurance perspective and analysis of factors having positive or negative effects on the implementation of the project in the study area. ETHICS AND DISSEMINATION: Ethical approval was obtained and all patients receive information about the study and give their consent to participate before randomisation. Results of the main trial and each of the secondary analyses will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT04188457. Registered on 6 December 2019.

CRT-D replacement strategy: results of the BioCONTINUE study.

BACKGROUND: In patients with cardiac resynchronization therapy defibrillators (CRT-Ds), the need for implantable cardioverter-defibrillator (ICD) back-up may be questionable at time of CRT-D replacement (REP) if ICD implant criteria are no longer met due to an improved left ventricular ejection fraction (LVEF) and if no major ventricular arrhythmic event (VAE) occurred during the CRT-D lifetime. The aim of our study was to assess the relevance of ICD back-up and predictors of VAE after REP in primary prevention CRT-D patients. METHODS: The prospective, observational, international BioCONTINUE study investigated the rate of patients with at least 1 sustained VAE (sVAE) post-REP and searched for predictive factors of sVAE. RESULTS: Two hundred seventy-six patients (70 ± 10 years, 77% men, mean LVEF 40.6 ± 12.6%) were followed for 28.4 ± 10.2 months. The rate of patients with sVAE was 8.3%, 10.3%, and 21.2% at 1, 2, and 4 years post-REP. Patients without persistent ICD indication at REP still had a sVAE rate of 5.7% (95% CI 2.3-11.5%) at 2 years. In multivariate analysis, predictive factors of subsequent sVAE were (i) persistent ICD indication (hazard ratio (HR) 3.6; 95% CI 1.6-8.3; p = 0.003); (ii) 64-72 years of age as compared to ≥ 79 years (HR 3.7; 95% CI 1.4-9.7; p = 0.008); and (iii) ischemic heart disease (HR 4.4; 95% CI 2.1-9.3; p < 0.0001). CONCLUSIONS: The risk of sVAE (21.2% at 4 years post-REP) depends on age, ischemic heart disease, and ICD indication at the time of REP. A non-trivial risk of sVAE remains in patients without persistent ICD indication. CLINICAL TRIAL REGISTRATION: NCT02323503.

Improved diagnostic performance of insertable cardiac monitors by an artificial intelligence-based algorithm.

AIMS: The increasing use of insertable cardiac monitors (ICM) produces a high rate of false positive (FP) diagnoses. Their verification results in a high workload for caregivers. We evaluated the performance of an artificial intelligence (AI)-based ILR-ECG Analyzer™ (ILR-ECG-A). This machine-learning algorithm reclassifies ICM-transmitted events to minimize the rate of FP diagnoses, while preserving device sensitivity. METHODS AND RESULTS: We selected 546 recipients of ICM followed by the Implicity™ monitoring platform. To avoid clusterization, a single episode per ICM abnormal diagnosis (e.g. asystole, bradycardia, atrial tachycardia (AT)/atrial fibrillation (AF), ventricular tachycardia, artefact) was selected per patient, and analyzed by the ILR-ECG-A, applying the same diagnoses as the ICM. All episodes were reviewed by an adjudication committee (AC) and the results were compared. Among 879 episodes classified as abnormal by the ICM, 80 (9.1%) were adjudicated as 'Artefacts', 283 (32.2%) as FP, and 516 (58.7%) as 'abnormal' by the AC. The algorithm reclassified 215 of the 283 FP as normal (76.0%), and confirmed 509 of the 516 episodes as abnormal (98.6%). Seven undiagnosed false negatives were adjudicated as AT or non-specific abnormality. The overall diagnostic specificity was 76.0% and the sensitivity was 98.6%. CONCLUSION: The new AI-based ILR-ECG-A lowered the rate of FP ICM diagnoses significantly while retaining a > 98% sensitivity. This will likely alleviate considerably the clinical burden represented by the review of ICM events.

[A territory project for the follow-up of strokes and myocardial infarctions]. / Un projet de territoire pour le suivi des accidents vasculaires cérébraux et des infarctus du myocarde.

The Dijon Vascular Project experiment aims to reduce the risk of unscheduled re-hospitalization for stroke and myocardial infarction. It involves hospital and private healthcare professionals working in the Côte-d'Or and South Haut-Marnais hospital grouping area. Within this system, hospital and private practice nurses are essential links in the patient's circle of care and fundamental contacts for post-stroke or post-MI follow-up: through their interventions, they contribute to preventing the risks of complications and recurrences.

Asymptomatic left circumflex artery stenosis is associated with higher arrhythmia recurrence after persistent atrial fibrillation ablation.

Background: The pathophysiology of persistent atrial fibrillation (AF) remains unclear. While several studies have demonstrated an association between myocardial infarction and atrial fibrillation, the role of stable coronary artery disease (CAD) is still unknown. As a result, we aimed to assess the association between CAD obstruction and AF recurrence after persistent AF ablation in patients with no history of CAD. Materials and methods: This observational retrospective study included consecutive patients who underwent routine preprocedural cardiac computed tomography (CCT) before persistent AF ablation between September 2015 and June 2018 in 5 European University Hospitals. Exclusion criteria were CAD or coronary revascularization previously known or during follow-up. Obstructive CAD was defined as luminal stenosis ≥ 50%. Results: All in all, 496 patients (mean age 61.8 ± 10.0 years, 76.2% males) were included. CHA2DS2-VASc score was 0 or 1 in 225 (36.3%) patients. Obstructive CAD was present in 86 (17.4%) patients. During the follow-up (24 ± 19 months), 207 (41.7%) patients had AF recurrence. The recurrence rate was not different between patients with and without obstructive CAD (43.0% vs. 41.5%, respectively; P = 0.79). When considering the location of the stenosis, the recurrence rate was higher in the case of left circumflex obstruction: 56% vs. 32% at 2 years (log-rank P ≤ 0.01). After Cox multivariate analysis, circumflex artery obstruction (HR 2.32; 95% CI 1.36-3.98; P < 0.01) was independently associated with AF recurrence. Conclusion: Circumflex artery obstruction detected with CCT was independently associated with 2-fold increase in the risk of AF recurrence after persistent AF ablation. Further research is necessary to evaluate this pathophysiological relationship.

Incidence, Characteristics, and Outcomes of Ventricular Fibrillation Complicating Acute Myocardial Infarction in Women Admitted Alive in the Hospital.

Background Little data are available in women presenting with ventricular fibrillation (VF) in the setting of acute myocardial infarction (AMI). We assessed frequency, predictors of VF, and outcomes, with a special focus on women compared with men. Methods and Results Data were analyzed from the FAST-MI (French Registry of Acute ST-Elevation or Non-ST-Elevation Myocardial Infarction) program, which prospectively included 14 406 patients admitted to French cardiac intensive care units ≤48 hours from AMI onset between 1995 and 2015 (mean age, 66±14 years; 72% men; mean left ventricular ejection fraction, 52±12%; 59% with ST-segment-elevation myocardial infarction). A total of 359 patients developed VF during AMI, including 81 women (2.0% of 4091 women) and 278 men (2.7% of 10 315 men, P=0.02). ST-segment-elevation myocardial infarction (odds ratio [OR], 2.29 [95% CI, 1.75-2.99]; P<0.001) was independently associated with the onset of VF during AMI. In contrast, female sex (OR, 0.73 [95% CI, 0.56-0.95]; P=0.02), hypertension (OR, 0.75 [95% CI, 0.60-0.94]; P=0.01), and prior myocardial infarction (OR, 0.69 [95% CI, 0.50-0.96]; P=0.03) were protective factors. Women were less likely to have cardiac intervention than men (percutaneous coronary intervention during hospitalization 48.1% versus 66.9%, respectively; P=0.04) with a higher 1-year mortality in women compared with men (50.6% versus 37.4%, respectively; P=0.03), including increased in-hospital mortality (42.0% versus 32.7%, respectively; P=0.12). After adjustment, female sex was no longer associated with a worse 1-year mortality (adjusted hazard ratio, 1.10 [95% CI, 0.75-1.61]; P=0.63). Conclusions Women have lower risk of developing VF during AMI compared with men. However, they are less likely to receive cardiac interventions than men, possibly contributing to missed opportunities of improved outcomes.

Smoking in Patients With Chronic Cardiovascular Disease During COVID-19 Lockdown.

Objectives: This cross-sectional study aims to investigate health-related behaviors including tobacco consumption among patients with cardiovascular diseases (CVD), during the first COVID-19-related lockdown. Methods: After 5 weeks of COVID-19 lockdown, 220 patients with chronic coronary syndromes (CCS) and 124 with congestive heart failure (CHF) answered a phone questionnaire. Results: Among these 344 patients, 43 (12.5%) were current smokers, and none had quit during the lockdown. When compared with non-smokers, smokers were 15 years younger, more often diabetic, more likely to live in an urban than a rural lockdown location, and more often in the CCS cohort (p = 0.011). Smokers described greater psychological impairment, but their rates of decrease in physical activity and of increase in screen time were similar to non-smokers. More than one-third (13/43) increased their tobacco consumption, which was mainly related to stress or boredom, but not driven by media messages on a protective effect of nicotine. Conclusions: During the first COVID-19 lockdown, we found a decrease in favorable lifestyle behaviors among patients with CVD. Strikingly, one-third of smokers with CCS or CHF increased their tobacco consumption. Given the major impact of persistent smoking in patients with CVD, this highlights the need for targeted prevention strategies, in particular during such periods.

Outcome of patients with early repolarization pattern and syncope.

BACKGROUND: Syncope in patients with an early repolarization (ER) pattern presents a challenge for clinicians as it has been identified as an indicator of a higher risk of life-threatening ventricular arrhythmias (VAs). OBJECTIVES: This study aimed to analyze the outcome of patients with an ER pattern and syncope and to evaluate the factors predictive of VAs. METHODS: Over a period of 5 years, we enrolled 143 patients with an ER pattern and syncope in a multicenter prospective registry. RESULTS: After the initial examinations, 97 patients (67.8%) were implanted with a device allowing electrocardiogram monitoring, including 84 (58.7%) with an implantable loop recorder. During a mean follow-up period of 68 ± 34 months, we documented 16 arrhythmias presumably responsible for syncope (5 VAs, 10 bradycardias, and 1 supraventricular tachycardia). Additionally, recurrent syncope not associated with electrocardiogram documentation occurred in 16 patients (11.2%). The cause of syncope was identified in 23 of 97 patients with a monitoring device (23.8%). The 5-year incidence of VAs and arrhythmic events presumably responsible for syncope was 4.9% and 11.0%, respectively. Patients who developed VAs showed no prodromes or specific triggers at the time of syncope. Neither the presence of a family history of sudden cardiac death nor the previously reported high-risk electrocardiographic parameters differed between patients with and without VAs. CONCLUSION: VAs occurred in 4.9% of patients with an ER pattern and syncope. Device implantation based on detailed history taking seems to be a reasonable strategy. Previously reported high-risk electrocardiographic patterns did not identify patients with VAs.

Efficacy and safety of the new TightRail™ mechanical sheath for transvenous lead extraction: Results of a French multicenter study.

INTRODUCTION: The aim of this study was to assess the safety and efficacy of the TightRail™ sheath for pacemaker/defibrillator transvenous lead extraction (TLE). METHODS: Multicenter observational study including patients who underwent a TLE with the TightRail™ sheath in five French university hospitals from September 2014 to January 2020. RESULTS: Two hundred and twenty-five patients (76% males, 71 ± 12 years) underwent a TLE procedure with the TightRail™. A total of 438 leads were extracted using the TightRail™, and the mean age of the extracted leads was 128 ± 85 months; of these, 344 (79%) were pacing leads and 94 (21%) were implantable cardioverter defibrillator leads. The overall clinical success of the extraction procedures was 93%. Overall, 410 of the 438 leads (95%) were extracted (complete or incomplete removal). After multilevel mixed-effects logistic regression model, we found that lead age (odds ratio [OR], 95% confidence interval [CI] for a 1 year increase: 1.11 [1.07-1.15], p < .001) and number of leads extracted (OR, 95% CI: 2.09 [1.50-2.96], p < .001) were the two independent factors associated with complete lead removal failure. Finally, there were 7 (3%) cases of major complications but no per-procedural death. CONCLUSION: This is the first large-scale survey assessing the efficacy and safety profile of the Tightrail™ mechanical sheath. The clinical success rate was 93%, and the lead removal failure was dependent on the age and number of leads. We show a satisfactory safety profile in this cohort of patients from primarily low-volume centers with older leads.

Cardiovascular outcomes after cardiac resynchronization therapy in cardiac amyloidosis.

AIMS: Cardiac resynchronization therapy (CRT) is highly effective in dilated cardiomyopathy (DCM) patients with impaired left ventricular ejection fraction (LVEF) and left bundle block branch. In cardiac amyloidosis (CA) patients, left ventricular dysfunction and conduction defects are common, but the potential of CRT to improve cardiac remodelling and survival in this particular setting remains undefined. We investigated cardiovascular outcomes in CA patients after CRT implantation in terms of CRT echocardiographic response and major cardiovascular events (MACEs). METHODS AND RESULTS: Our retrospective study included 47 CA patients implanted with CRT devices from January 2012 to February 2020, in nine French university hospitals (77 ± 6 years old, baseline LVEF 30 ± 8%) compared with propensity-matched (1:1 for age, LVEF at implantation, and CRT indication) DCM patients with a CRT device. CA patients had lower rates of CRT response (absolute delta LVEF ≥ 10%) compared with DCM patients (36% vs. 70%, P = 0.002). After multivariate Cox analysis, CA was independently associated with MACE (hospitalization for heart failure/cardiovascular death) [hazard ratio (HR) 3.73, 95% confidence interval (CI) 1.85-7.54, P < 0.001], along with the absence of CRT response (HR 3.01, 95% CI 1.56-5.79, P = 0.001). The presence of echocardiographic CRT response (absolute delta LVEF ≥ 10%) was the only predictive factor of MACE-free survival in CA patients (HR 0.36, 95% CI 0.15-0.86, P = 0.002). CONCLUSION: Compared with a matched cohort of DCM patients, CA patients had a lower rate of CRT response and consequently a worse cardiovascular prognosis after CRT implantation. However, CRT could be beneficial even in CA patients given that CRT response was associated with better cardiac outcomes in this population.

No impact of sub-clinical coronary artery disease identified by cardiac CT scan on the recurrence of atrial fibrillation after a single ablation procedure.

BACKGROUND: Performing a cardiac CT scan before ablation provides a better understanding of the anatomical variations of the left atrium and pulmonary veins, as well as an analysis of coronary anatomy and the calcium score. The aim of the present study was to determine whether the CT characteristics of patients with unknown CAD have an impact on recurrence of AF. METHODS: This monocentric retrospective study included patients with AF who had undergone cardiac CT prior to a single ablation. RESULTS: Among the 229 patients included in the study, 70 (30.5%) presented AF recurrence between 3 and 12 months after a single ablation. The prevalence of CAD confirmed by CT coronary angiogram and the coronary calcium score were similar in the two groups. Patients with recurrent atrial fibrillation had a significantly higher LAVI evaluated by CT scan than patients without recurrence. The ROC curve determined an optimal LAVI threshold of 49 mL/m2. In multivariate analysis, the LAVI measured by CT scan was independently associated with the risk of AF recurrence. CONCLUSIONS: Our study confirms that CAD is not a predictor of AF recurrence after a single ablation, unlike the LAVI. Further studies are necessary to re-evaluate the long-term conclusions of this work.