Aims The explosion of novel anticancer therapies has meant emergence of cardiotoxicity signals including atrial fibrillation (AF). Reliable data concerning the liability of anticancer drugs in inducing AF are scarce. Using the World Health Organization individual case safety report database, VigiBase®, we aimed to determine the association between anticancer drugs and AF. Methods and results A disproportionality analysis evaluating the multivariable-adjusted reporting odds ratios for AF with their 99.97% confidence intervals was performed for 176 U.S. Food and Drug Administration (FDA)- or European Medicines Agency (EMA)-labelled anticancer drugs in VigiBase®, followed by a descriptive analysis of AF cases for the anticancer drugs identified in VigiBase®. ClinicalTrial registration number: NCT03530215. A total of 11 757 AF cases associated with at least one anticancer drug were identified in VigiBase® of which 95.8% were deemed serious. Nineteen anticancer drugs were significantly associated with AF of which 14 (74%) are used in haematologic malignancies and 9 (45%) represented new AF associations not previously confirmed in literature including immunomodulating agents (lenalidomide, pomalidomide), several kinase inhibitors (nilotinib, ponatinib, midostaurin), antimetabolites (azacytidine, clofarabine), docetaxel (taxane), and obinutuzumab, an anti-CD20 monoclonal antibody. Conclusion Although cancer malignancy itself may generate AF, we identified 19 anticancer drugs significantly associated with a significant increase in AF over-reporting. This pharmacovigilance study provides evidence that anticancer drugs themselves could represent independent risk factors for AF development. Dedicated prospective clinical trials are now required to confirm these 19 associations. This list of suspected anticancer drugs should be known by physicians when confronted to AF in cancer patients, particularly in case of haematologic malignancies.

This study was designed to define the current role of multislice spiral computed tomography (MSCT) for the diagnosis of coronary in-stent restenosis using a meta-analytic process. Restenosis remains a limitation after coronary stent implantation and contributes to a substantial number of coronary re-assessments by conventional invasive coronary angiography (CA). We identified 15 studies (807 patients) evaluating in-stent restenosis by means of both MSCT (>or=16 slices) and conventional CA until February 2007. After data extraction the analysis was performed according to a random-effects model. The analysis pooled the results from 15 studies with a total of 1,175 stents. A substantial number of unassessable stents (13%) were excluded from the analysis underscoring the shortcomings of MSCT. With this major limitation the diagnostic performance of MSCT for in-stent restenosis detection can be summarized as follows: the sensitivity and specificity were 84% [95% confidence interval (CI) 77-89%] and 91% (95% CI 89-93%), respectively, with positive and negative likelihood ratios of 12.2 (95% CI 6.6-22.6) and 0.23 (95% CI 0.17-0.31), respectively, and with a diagnostic odds ratio of 67.9 (95% CI 34.4-134.1). MSCT has shortcomings difficult to overcome in daily practice for in-stent restenosis detection and continues to have moderately high sensitivity and specificity. The diagnostic role of this emerging technology as an alternative to CA for in-stent restenosis detection remains limited.

Background: Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart disease, and sudden cardiac death represents an important mode of death in these patients. Data evaluating the implantable cardioverter defibrillator (ICD) in this patient population remain scarce. Methods: Nationwide French Registry including all TOF patients with an ICD initiated in 2010 by the French Institute of Health and Medical Research. The primary time to event endpoint was the time from ICD implantation to first appropriate ICD therapy. Secondary outcomes included ICD-related complications, heart transplantation, and death. Clinical events were centrally adjudicated by a blinded committee. Results: A total of 165 patients (mean age 42.2±13.3 years, 70.1% males) were included from 40 centers, including 104 (63.0%) in secondary prevention. During a median (IQR) follow-up of 6.8 (2.5-11.4) years, 78 (47.3%) patients received at least one appropriate ICD therapy. The annual incidence of the primary outcome was 10.5% (7.1% and 12.5% in primary and secondary prevention, respectively, p=0.03). Overall, 71 (43.0%) patients presented with at least one ICD complication, including inappropriate shocks in 42 (25.5%) patients and lead dysfunction in 36 (21.8%) patients. Among 61 (37.0%) primary prevention patients, the annual rate of appropriate ICD therapies was 4.1%, 5.3%, 9.5%, and 13.3% in patients with respectively no, one, two, or ≥ three guideline-recommended risk factors. QRS fragmentation was the only independent predictor of appropriate ICD therapies (HR 3.47, 95% CI 1.19-10.11), and its integration in a model with current criteria increased the 5-year time-dependent area under the curve from 0.68 to 0.81 (p=0.006). Patients with congestive heart failure and/or reduced LVEF had a higher risk of non-arrhythmic death or heart transplantation (HR=11.01, 95% CI: 2.96-40.95). Conclusions: Patients with TOF and an ICD experience high rates of appropriate therapies, including those implanted in primary prevention. The considerable long-term burden of ICD-related complications, however, underlines the need for careful candidate selection. A combination of easy-to-use criteria including QRS fragmentation might improve risk stratification. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT03837574

Aims Limited data exist concerning fragmented QRS complexes (fQRSs) on the surface electrocardiogram (ECG) of apparently healthy athletes. We aimed to study the prevalence and significance of fQRS in lead V1 (fQRSV1), representing right ventricular (RV) activation, regarding training-induced RV morphological remodelling. Methods and results Between January 2017 and August 2019, 434 consecutive non-sedentary subjects underwent preparticipation cardiovascular screening, including a 12-lead ECG. Three hundred and ninety-three apparently healthy subjects were included, 119 of them were athletes (defined as performing ≥8 h/week for the last 6 months) and 274 were non-athletes. All athletes underwent two-dimensional transthoracic echocardiography. Fragmented QRS complex in lead V1 pattern was defined as a narrow (<120 ms) and quadriphasic QRS complex in lead V1. Fragmented QRS complex in lead V1 was more frequent in athletes compared with non-athletes (22% vs. 5.1%, P < 0.001) and was independently associated with the athlete status [adjusted odds ratio (aOR) = 4.693, 95% confidence interval (95% CI) 2.299—9.583; P < 0.001], the endurance category (aOR = 2.522, 95% CI 1.176—5.408; P = 0.017), and age (aOR = 0.962, 95% CI 0.934–0.989; P = 0.007) in multivariate analysis. In the subgroup of athletes, fQRSV1 was independently associated with mean RV outflow tract diameter (aOR = 1.458, 95% CI 1.105–1.923; P = 0.008) and age (aOR = 0.941, 95% CI 0.894–0.989; P = 0.017) in multivariate analysis. Conclusion Fragmented QRS complex in lead V1 is a newly described, frequent, ECG pattern in young and apparently healthy athletes and is associated with training-induced RV remodelling.

BACKGROUND: Recurrences of atrial fibrillation (AF) after pulmonary vein isolation (PVI) are mainly due to pulmonary vein reconnection. However, a growing number of patients have AF recurrences despite durable PVI. The optimal ablative strategy for these patients is unknown. We analyzed the impact of current ablation strategies in a large multicenter study. METHODS: Patients undergoing a redo ablation for AF and presenting durable PVI were included. The freedom from atrial arrhythmia after pulmonary vein-based, linear-based, electrogram-based, and trigger-based ablation strategies were compared. RESULTS: Between 2010 and 2020, 367 patients (67% men, 63±10 years, 44% paroxysmal) underwent a redo ablation for AF recurrences despite durable PVI at 39 centers. After durable PVI was confirmed, linear-based ablation was performed in 219 (60%) patients, electrogram-based ablation in 168 (45%) patients, trigger-based ablation in 101 (27%) patients, and pulmonary vein-based ablation in 56 (15%) patients. Seven patients (2%) did not undergo any additional ablation during the redo procedure. After 22±19 months of follow-up, 122 (33%) and 159 (43%) patients had a recurrence of atrial arrhythmia at 12 and 24 months, respectively. No significant difference in arrhythmia-free survival was observed between the different ablation strategies. Left atrial dilatation was the only independent factor associated with arrhythmia-free survival (HR, 1.59 [95% CI, 1.13–2.23]; P =0.006). CONCLUSIONS: In patients with recurrent AF despite durable PVI, no ablation strategy used alone or in combination during the redo procedure appears to be superior in improving arrhythmia-free survival. Left atrial size is a significant predictor of ablation outcome in this population.

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Introduction Pulmonary vein isolation (PVI) is well established as a primary treatment for atrial fibrillation (AF). The POLAR ICE study was designed to collect prospective real world data on the safety and effectiveness of the POLARxTM cryoballoon for PVI to treat paroxysmal AF. Methods POLAR ICE, a prospective, non‐randomized, multicenter (international) registry (NCT04250714), enrolled 399 patients across 19 European centers. Procedural characteristics, such as time to isolation, cryoablations per pulmonary vein (PV), balloon nadir temperature, and occlusion grade were recorded. PVI was confirmed with entrance block testing. Results Data on 372 de novo PVI procedures (n = 2190 ablations) were collected. Complete PVI was achieved in 96.8% of PVs. Procedure and fluoroscopy times were 68.2 ± 24.6 and 15.6 ± 9.6 min, respectively. Left atrial dwell time was 46.6 ± 18.3 min. Grade 3 or 4 occlusion was achieved in 98.2% of PVs reported and 71.2% of PVs isolation required only a single cryoablation. Of 2190 cryoapplications, 83% had a duration of at least 120 s; nadir temperature of these ablations averaged −56.3 ± 6.5°C. There were 6 phrenic nerve palsy events, 2 of which resolved within 3 months of the procedure. Conclusion This real‐world usage data on a novel cryoballoon suggests this device is effective, safe, and relatively fast in centers with cryoballoon experience. These data are comparable to prior POLARx reports and in keeping with reported data on other cryoballoons. Future studies should examine the long‐term outcomes and the relationship between biophysical parameters and outcomes for this novel cryoballoon.