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Background Predictors of high-degree atrioventricular block (HAVB) after transcatheter aortic valve replacement (TAVR) are recognized, but the electrophysiological study's (EPS) role is still a subject to debate. The objective of our study was to determine factors associated with PPM implantation including the potential role of EPS before and/or after TAVR. Methods and results Seventy four consecutive patients (pts) were included and 21 pts (28.4%) received a PPM during the immediate postoperative follow-ups (until Day 5): HAVB in 15 pts (71.4%), prophylactic implantation due to a documented increased HV interval ≥ 95-100 ms plus LBBB in 2 pts (9.5%), a high-degree HV block evidenced at the EPS plus LBBB in 3 pts (14.3%) and one additional patient was implanted for AV-block in presence of AFib (4.8%). In the multivariate model 1 including parameters before TAVR, both prosthesis diameter and PR lengthening remained significantly associated with PPM as well RBBB. In the multivariate model 2 including parameters after TAVR, only HV remained significantly associated with the risk of PPM (OR = 1.15 (1.05-1.26), p = .004). When all the significant variables in models 1 and 2 were analyzed together in model 3, only HV after TAVR remained significantly associated with an increased risk of PPM. Conclusions In this prospective observational study, it was revealed that a Day 4-5 EPS is likely to more precisely stratify the risk of PPM implantation regarding its ability to discover asymptomatic severe infra-hisian conduction disturbances particularly in presence of LBBB. Multivariate analysis confirmed the prognostic value of HV alteration.

Background In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1 month compared with standard antiplatelet regimens after coronary stent implantation did not improve outcomes at intention‐to‐treat analysis. Considerable differences in treatment adherence between the experimental and control groups may have affected the intention‐to‐treat results. In this reanalysis of the GLOBAL LEADERS trial, we compared the experimental and control treatment strategies in a per‐protocol analysis of patients who did not deviate from the study protocol. Methods and Results Baseline and postrandomization information were used to classify whether and when patients were deviating from the study protocol. With logistic regressions, we derived time‐varying inverse probabilities of nondeviation from protocol to reconstruct the trial population without protocol deviation. The primary end point was a composite of all‐cause mortality or nonfatal Q‐wave myocardial infarction at 2 years. At 2‐year follow‐up, 1103 (13.8%) of 7980 patients in the experimental group and 785 (9.8%) of 7988 patients in the control group qualified as protocol deviators. At per‐protocol analysis, the rate ratio for the primary end point was 0.88 (95% CI, 0.75–1.03; P =0.10) on the basis of 274 versus 325 events in the experimental versus control group. The rate ratio for the key safety end point of major bleeding was 1.00 (95% CI, 0.79–1.26; P =0.99). The per‐protocol and intention‐to‐treat effect estimates were overall consistent. Conclusions Among patients who complied with the study protocol in the GLOBAL LEADERS trial, ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy was not superior to 1‐year standard dual antiplatelet therapy followed by aspirin alone at 2 years after coronary stenting. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01813435.

BACKGROUND Beta-blocker (β-blocker) therapy has been shown to improve mortality and reduce hospitalizations in patients with heart failure (HF) with reduced ejection fraction (HFrEF). Although the physiological action mechanisms of β-blockers are well described, their effects on right ventricular (RV) function have not been prospectively studied. OBJECTIVE This prospective study aimed to (a) evaluate whether β-blocker therapy impacts RV remodeling based on echo parameters and (b) determine the predictive echo factors of β-blocker therapy response. METHODS From September 2017 to September 2018, HF patients were prospectively enrolled using CIBIS criteria: Class II, III, or IV HF; left ventricular ejection fraction (LVEF) of ≤40%; hospitalized for HF within the previous 12 months. Echo evaluation was performed before initiating β-blocker therapy and 3 months after optimal dose adjustment. Based on previous studies, patients with (absolute) LVEF ≥ 5% improvement were considered significant β-blocker therapy responders. RESULTS Overall, 40 patients (pts) completed the study, characterized as follows by age: 70 ± 10 years; gender: 10 women; cardiomyopathy etiology: idiopathic in 24 and ischemic in 16; NYHA Class: II in 22 and III in 10; LVEF: 32 ± 5%; and NTProBNP: 2665 ± 2400 pg/mL. The final population comprised 32 pts (79%), with eight (21%) excluded: two because of β-blocker therapy intolerance, one lost to follow-up, and five withdrew from the study. Under β-blocker therapy, several echo parameters significantly improved: LVEF from 31.7 ± 9 to 40.5 ± 9 (P

International audience; The clinical efficacy of the inhibitors of the renin-angiotensin-aldosterone system (RAAS) as an upstream therapy for atrial fibrillation (AF) prevention is controversial. No study has itemized so far the role of RAAS inhibitors in AF prevention after atrial flutter (AFL) ablation. This trial aims to investigate the effect of ramipril compared with placebo on AF occurrence in patients hospitalized for AFL ablation without structural heart disease. The Prevention of Atrial Fibrillation by Inhibition Conversion Enzyme (ICE) After Radiofrequency Ablation of Atrial Flutter (PREFACE) trial was a prospective, multicenter, randomized, double-blind, double-dummy trial depicting the AF occurrence during a 12-month follow-up as the primary end point. A total of 198 patients hospitalized for AFL ablation were enrolled in the trial and randomized to placebo or ramipril 5 mg/day. Patients were followed up during 1 year after AFL ablation using 1-week Holter electrocardiogram at 3, 6, 9, and 12 months. The intention-to-treat population encompassed 97 patients in the ramipril group and 101 patients in the placebo group. The primary end point, such as AF occurrence during the 1-year follow-up, was not different between the 2 groups (p = 0.96). Secondary end points, including the occurrence of supraventricular arrhythmia (p = 0.50), heart failure, stroke, and death, were not different between the 2 groups. Safety outcome parameters, including serious adverse events leading to treatment disruption (p = 0.10), hypotension, impairment of renal function, and elevated serum potassium level, also were not different between the 2 groups. In conclusion, RAAS inhibition using ramipril does not reduce AF occurrence in patients facing AFL ablation during the 1-year follow-up.

Funding Acknowledgements Type of funding sources: None. Background. Limited data exist regarding the prevalence of left atrial appendage (LAA) thrombi and spontaneous echocardiographic contrast (SEC) in patients with atrial flutter (AFL). Objectives. Our prospective single-center observational study sought to evaluate the prevalence of LAA thrombi in patients referred for AFL ablation, compared to those requiring atrial fibrillation (AFib) ablation during the same time period, as well as to determine the predictive factors of LAA thrombi in terms of arrhythmia etiology. Methods and Results. From July 2019 to August 2020, 321 consecutive patients who were referred for either AFib ablation (n = 229) or AFL ablation (n = 92) were included in the study, with a thrombus detected by transesophageal echocardiography (TEE) in 3.22% (12/321). Prior to ablation under anticoagulants, the percentage of thrombi was similar between patients referred for AFL ablation and those referred for AFib ablation (5.4% [n = 5/92] vs. 3.1% [n = 7/229]; p = 0.3). In the overall population, patients with LAA thrombi had a higher CHA²DS²-VASc score (3 ± 2 vs. 2 ± 1.5; p = 0.048) and a higher presence of valvular prothesis (25% vs. 4.9%; p = 0.003), with relevant left atrial remodeling more often observed, such as demonstrated by a higher left atrium (LA) volume (57 ± 19 vs. 46 ± 17 ml/m²; p = 0.04), a lower LAA velocity (0.41 ± 0.3 vs. 0.55 ± 0.2; p = 0.04) and a more severe LAA echo contrast (83.3% vs. 3.2%; p

International audience; Background: Percutaneous coronary intervention (PCI)-related myonecrosis is frequent and can affect the long-term prognosis of patients. To our knowledge, ticagrelor has not been evaluated in elective PCI and could reduce periprocedural ischaemic complications compared with clopidogrel, the currently recommended treatment. The aim of the ALPHEUS study was to examine if ticagrelor was superior to clopidogrel in reducing periprocedural myocardial necrosis in stable coronary patients undergoing high-risk elective PCI.Methods: The ALPHEUS study, a phase 3b, randomised, open-label trial, was done at 49 hospitals in France and Czech Republic. Patients with stable coronary artery disease were eligible for the study if they had an indication for PCI and at least one high-risk characteristic. Eligible patients were randomly assigned (1:1) to either ticagrelor (180 mg loading dose, 90 mg twice daily thereafter for 30 days) or clopidogrel (300-600 mg loading dose, 75 mg daily thereafter for 30 days) by use of an interactive web response system, and stratified by centre. The primary outcome was a composite of PCI-related type 4 (a or b) myocardial infarction or major myocardial injury and the primary safety outcome was major bleeding, both of which were evaluated within 48 h of PCI (or at hospital discharge if earlier). The primary analysis was based on all events that occurred in the intention-to-treat population. The trial was registered with ClinicalTrials.gov, NCT02617290.Findings: Between Jan 9, 2017, and May 28, 2020, 1910 patients were randomly assigned at 49 sites, 956 to the ticagrelor group and 954 to the clopidogrel group. 15 patients were excluded from the ticagrelor group and 12 from the clopidogrel group. At 48 h, the primary outcome was observed in 334 (35%) of 941 patients in the ticagrelor group and 341 (36%) of 942 patients in the clopidogrel group (odds ratio [OR] 0·97, 95% CI 0·80-1·17; p=0·75). The primary safety outcome did not differ between the two groups, but minor bleeding events were more frequently observed with ticagrelor than clopidogrel at 30 days (105 [11%] of 941 patients in the ticagrelor group vs 71 [8%] of 942 patients in the clopidogrel group; OR 1·54, 95% CI 1·12-2·11; p=0·0070).Interpretation: Ticagrelor was not superior to clopidogrel in reducing periprocedural myocardial necrosis after elective PCI and did not cause an increase in major bleeding, but did increase the rate of minor bleeding at 30 days. These results support the use of clopidogrel as the standard of care for elective PCI.Funding: ACTION Study Group and AstraZeneca.

Radiofrequency ablation (RF) is a treatment of choice for atrial fibrillation (AF) because of a positive risk/benefit...

Systems of care have been challenged to control progression of the COVID-19 pandemic. Whether this has been associated with delayed reperfusion and worse outcomes in French patients with ST-segment elevation myocardial infarction (STEMI) is unknown.Aim: To compare the rate of STEMI admissions, treatment delays, and outcomes between the first peak of the COVID-19 pandemic in France and the equivalent period in 2019.Methods: In this nationwide French survey, data from consecutive STEMI patients from 65 centres referred for urgent revascularization between 1 March and 31 May 2020, and between 1 March and 31 May 2019, were analysed. The primary outcome was a composite of in-hospital death or non-fatal mechanical complications of acute myocardial infarction.Results: A total of 6306 patients were included. During the pandemic peak, a 13.9±6.6% (P=0.003) decrease in STEMI admissions per week was observed. Delays between symptom onset and percutaneous coronary intervention were longer in 2020 versus 2019 (270 [interquartile range 150-705] vs 245 [140-646]min; P=0.013), driven by the increase in time from symptom onset to first medical contact (121 [60-360] vs 150 [62-420]min; P=0.002). During 2020, a greater number of mechanical complications was observed (0.9% vs 1.7%; P=0.029) leading to a significant difference in the primary outcome (112 patients [5.6%] in 2019 vs 129 [7.6%] in 2020; P=0.018). No significant difference was observed in rates of orotracheal intubation, in-hospital cardiac arrest, ventricular arrhythmias and cardiogenic shock.Conclusions: During the first peak of the COVID-19 pandemic in France, there was a decrease in STEMI admissions, associated with longer ischaemic time, exclusively driven by an increase in patient-related delays and an increase in mechanical complications. These findings suggest the need to encourage the population to seek medical help in case of symptoms., Contexte. Les systèmes de santé à travers le monde ont été fortement mis à l’épreuve afin de contrôler la progression de l’épidémie de la COVID-19. L’éventualité que la réorganisation des soins ait pu influencer les délais de reperfusion ou le devenir des patients présentant des syndromes coronaires aigus avec sus-décalage du segment ST (SCA ST +) n’a pas été explorée en France.Objectif. Comparer le taux d’admissions pour SCA ST+, les délais de traitement et enfin le devenir de ces patients entre la première vague épidémique de la COVID-19 et pendant la période similaire en 2019.Méthodes. Dans ce registre national multicentrique, les patients avec SCA ST+ provenant de 65 centres français admis en urgence pour revascularisation entre le 1e mars et le 31 mai 2020 et entre le 1e mars et le 31 mai 2019 ont été analysés. Le critère de jugement principal était un critère composite regroupant la mortalité intrahospitalière toute cause confondue et les complications mécaniques en lien avec l’infarctus.Résultats. Un total de 6 306 patients ont été inclus. Pendant le pic de la pandémie une réduction de 13,9 ± 6,6 % (P = 0,003) des admissions pour SCA ST+ a été observée par semaine. Les délais entre l’apparition des symptômes et l’angioplastie percutanée était significativement augmentés 270 (150−705) versus 245 (140−646) minutes (P = 0,013). Cette augmentation était exclusivement liée à une augmentation du temps entre l’apparition des symptômes et le premier contact médical 121 (60−360) en 2019 versus 150 (62−420) minutes en 2020 (P = 0,002). Durant cette période a été constaté un plus grand nombre de complications mécaniques (0,9 % vs 1,7 % (P = 0,029) conduisant à une augmentation significative de notre critère de jugement principal 112 patients (5,6) en 2019 vs 129 (7,6 %) en 2020 (P = 0,018).Conclusions. Pendant le premier pic de la pandémie il a été constaté : une diminution du taux de SCA ST + associé à un temps d’ischémie prolongé, poussé par l’augmentation du temps entre l’apparition des symptômes et le premier contact médical et enfin un plus grand nombre de complications mécaniques. Ces observations suggèrent la nécessité d’encourager la population à consulter au moindre symptôme inquiétant.

Background We hypothesised that ticagrelor, in combination with aspirin for 1 month, followed by ticagrelor alone, improves outcomes after percutaneous coronary intervention compared with standard antiplatelet regimens. Methods GLOBAL LEADERS was a randomised, open-label superiority trial at 130 sites in 18 countries. Patients undergoing percutaneous coronary intervention with a biolimus A9-eluting stent for stable coronary artery disease or acute coronary syndromes were randomly assigned (1:1) to 75-100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy, or standard dual antiplatelet therapy with 75-100 mg aspirin daily plus either 75 mg clopidogrel daily (for patients with stable coronary artery disease) or 90 mg ticagrelor twice daily (for patients with acute coronary syndromes) for 12 months, followed by aspirin monotherapy for 12 months. Randomisation was concealed, stratified by centre and clinical presentation (stable coronary artery disease vs acute coronary syndrome), and blocked, with randomly varied block sizes of two and four. The primary endpoint at 2 years was a composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction as assessed by a core lab in a blinded manner. The key secondary safety endpoint was site-reported bleeding assessed according to the Bleeding Academic Research Consortium criteria (grade 3 or 5). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01813435, and is closed to new participants, with followup completed. Findings Between July 1, 2013, and Nov 9, 2015, 15 968 participants were randomly assigned, 7980 to the experimental group and 7988 to the control group. At 2 years, 304 (3.81%) participants in the experimental group had died or had a non-fatal centrally adjudicated new Q-wave myocardial infarction, compared with 349 (4.37%) participants in the control group (rate ratio 0.87 [95% CI 0. 75-1. 01]; p=0.073]). There was no evidence for a difference in treatment effects for the primary endpoint across prespecified subgroups of acute coronary syndromes and stable coronary artery disease (p=0.93). Grade 3 or 5 bleeding occurred in 163 participants in the experimental group and 169 in the control group (2.04% vs 2.12%; rate ratio 0.97 [95% CI 0. 78-1. 20]; p=0.77). Interpretation Ticagrelor in combination with aspirin for 1 month followed by ticagrelor alone for 23 months was not superior to 12 months of standard dual antiplatelet therapy followed by 12 months of aspirin alone in the prevention of all-cause mortality or new Q-wave myocardial infarction 2 years after percutaneous coronary intervention. Copright (C) 2018 Elsevier Ltd. All rights reserved. European Clinical Research Institute; Biosensors International; AstraZeneca; Medicines Company; Canada Research Chairs Programme

Background Catheter ablation of atrial fibrillation (AFib) primarily relies upon pulmonary vein isolation (PVI), but such procedures are associated with significant X-ray exposure. The newer Epoch system has been developed so as to enable more precise magnetic navigation whilst limiting X-ray exposure. Objectives This study was aimed at quantifying both exposure time and X-ray reduction with the newer Epoch system compared to Niobe II during AFib ablation procedures. Methods From November 2011 to November 2013, our last 92 consecutive patients treated with the Niobe ES (Epoch Solution; 4th generation magnetic navigation technology) system were compared with the first 92 consecutive patients treated using the Niobe II system (3rd generation magnetic navigation technology) for symptomatic drug-refractory AFib. Results Mean patient age was 59±11years (20% female), and the study population was affected by either symptomatic paroxysmal (65.2%) or persistent (34.8%) AFib. Median procedure time was 2±0.5h and median total X-ray exposure 12.3±6.4min. Procedure time (1.9±0.4 vs. 2.7±1h, p p =0.001) were significantly lower with Niobe ES than with the Niobe II system. X-ray ablation exposure time was also significantly lower with the Niobe ES system than with the Niobe II system (2.9±2 vs. 4±3.5min; p =0.01). Through multivariate analysis, the only predictive factors influencing both procedure duration and X-ray exposure were found to be the Niobe ES system use and LA size. Conclusions Our study was the first to demonstrate that the new Niobe ES magnetic robotic system substantially reduced overall operating, fluoroscopy, and ablation times during AFib ablation procedure.

International audience; Background After acute myocardial infarction (AMI), reperfusion injury is associated with microvascular lesions and myocardial edema. Purpose To evaluate the performance of apparent diffusion coefficient (ADC) quantification compared with T1 and T2 values in the detection of acute myocardial injury. Materials and Methods In this prospective study conducted from June 2016 to November 2018, participants without a history of heart failure or cardiomyopathy were enrolled after undergoing reperfusion for their first AMI. Quantitative T1 and T2 mapping were performed with a 1.5-T MRI scanner and compared with a fast free-breathing acquisition technique for ADC mapping (approximate duration, 3 minutes; five slices; spin-echo cardiac diffusion acquisition; b values, 0 and 200 sec/mm(2); six diffusion-encoding directions; five repetitions). Quantitative ADC and unenhanced T1 and T2 values were compared in infarct, border, and remote regions by using Welch analysis of variance with Games-Howell post hoc test for pairwise comparisons. Results Thirty-four participants with AMI underwent MRI an average of 5 days ± 1.9 (standard deviation) after reperfusion. Mean ADC was markedly high in the infarcted regions (2.32 × 10(-3) mm(2)/sec; 95% confidence interval [CI]: 2.28, 2.36) and moderately high in the border regions (1.91 ×10(-3) mm(2)/sec; 95% CI: 1.89, 1.94; P \textless .001). In remote regions, mean ADC (1.62 ×10(-3) mm(2)/sec; 95% CI: 1.59, 1.64) was comparable to that measured in vivo in healthy volunteers. Within the same regions of interest, although the measures showed similar trends in infarct and remote regions for T1 (mean, 1332 mec [95% CI: 1296, 1368] vs 1045 msec [95% CI: 1034, 1056]; P \textless .001) and T2 (72 msec [95% CI: 69, 75] vs 50 msec [95% CI: 49, 51]; P \textless .001), the magnitude of the differences among regions was greater when using ADC. Normalized signal differences between infarct and remote regions showed that diffusion-weighted MRI depicted edema 5.1 (P \textless .001) and 3.5 (P \textless .001) times greater than did T1 and T2 maps, respectively. Conclusion Multislice cardiac diffusion-weighted images could be acquired in those with acute myocardial injury. Quantitative apparent diffusion coefficient mapping showed greater differences among remote regions and lesions than did T1 or T2 mapping.

Background Following acute myocardial infarction (AMI), most patients receive potent antithrombotic medications, which may promote nuisance bleedings (ecchymoses, minor nose or dental bleeds etc.). Little information is available on the factors related to nuisance bleedings, nor on their prognostic significance in post-AMI patients. Aims and methods A health status questionnaire was sent to all patients participating in the nationwide French FAST-MI cohorts (2010 and 2015) one year after the acute episode, with a specific question on the presence of nuisance bleedings. Overall, 3968 patients answered the question on the presence nuisance bleedings. In the 2010 cohorts, we also analysed whether the presence of nuisance bleedings at one year was an independent correlate of 5-year mortality. Results 54% of the patients reported the presence of nuisance bleedings (59% in 2010 and 51% in 2015). In univariate analyses, nuisance bleedings were more frequently found in younger patients, women, patients with STEMI, current smokers, patients treated with PCI, those receiving newer P2Y12 inhibitors or ACE-inhibitors but less frequent in patients with diabetes, hypertension, or those receiving ARBs or direct oral anticoagulants. Using logistic regression analysis, however, the only independent correlates of nuisance bleedings were: female gender (OR 1.45, 1.25–1.68), age ≤60 years (OR 1.22, 1.06–1.41), VKAs (OR 1.72, 1.28–2.31), clopidogrel (OR 1.62, 1.29–2.03), prasugrel (OR 3.16, 2.43–4.09), ticagrelor (OR 2.61, 2.04–3.35) at discharge, diabetes (OR 0.74, 0.63–0.88) and year 2015 vs 2010 (OR 0.62, 0.53–0.73). In the 2010 cohort, the presence of nuisance bleeding at one year was not a predictor of mortality at 5 years (90% survival in both patients with or without nuisance bleedings; adjusted HR 0.96, 95% CI 0.69–1.33) (Figure). Figure 1. 5-yr survival by nuisance bleed Conclusion Nuisance bleedings one year after AMI are extremely frequent. They are more common in women, younger patients, in patients receiving P2Y12 inhibitors, especially newer P2Y12-i, and in those receiving VKAs; in contrast, diabetic patients report less nuisance bleedings. The presence of nuisance bleeding at one year does not appear to impact 5-year mortality. Acknowledgement/Funding Amgen, AstraZeneca, Bayer, Daiichi-Sankyo, Eli-Lilly, GSK, MSD, Novartis, Pfizer, Sanofi, Servier

International audience; Background - Pre-participation cardiovascular evaluation (PPE) aims to detect cardiac disease with sudden cardiac death (SCD) risk. No study has focused on Pacific Island athletes. Methods - A total of 2281 Pacific Island athletes were studied with (i) a questionnaire on family, personal history and symptoms, (ii) a physical examination and (iii) a 12-lead ECG. Results - 85% presented a normal history and examination. A positive family history was 1.4-1.9 fold higher in Melanesians, Polynesians and Métis than in Caucasians, while a positive personal history, abnormal symptoms and abnormal examination was 1.3 fold higher in Melanesians and Métis than in others. Neither gender nor training level had a bearing on these results. Melanesians had higher T wave inversions (TWIs) in V2-V4 leads but had no CV abnormalities. Lateral or infero-lateral TWIs were found in 6 male and in 5 highly trained athletes and cardiomyopathies were diagnosed in 3/6 athletes. Overall, 3.9% athletes were found to have a CV abnormality and 0.8% had a risk of SCD. Polynesians and males were more at risk than the others while the level of training made no difference. In athletes at risk of SCD, the main detected CV diseases were cardiomyopathies, Wolff-Parkinson-White (WPW) and severe valve lesions of rheumatoid origin. Conclusions - PPE revealed that 3.9% presented CV abnormalities. A risk of SCD was found in 0.8% with cardiomyopathies, WPW, and severe valve lesions of rheumatoid origin. Melanesians, Polynesians and male of high level of training were more at risk than others.

Background Percutaneous coronary intervention (PCI) for bifurcation lesions (BL) using 2 stents technique is known to be associated with high rates of procedural failure especially on the side branch (SB) mainly due to stent incomplete apposition. Stent deployment at very high pressure (SDHP) may lead to better stent expansion and apposition. However, SDHP may also be at the origin of deeper wall injury resulting into major cardiac adverse events. No data are available on evaluation of SDHP in BL treated by a mini-crush stent technique. Methods One hundred and thirteen consecutive patients underwent PCI for BL (Medina 1, 1, 1) using a mini-crush stent technique with SDHP defined as ≥20 atm. An angiographic follow-up was performed at 6 month and clinical follow-up was obtained at a median of 3 years. Results Stent deployment mean pressures were 20 ± 1.4 atm (range 20–25) in the main vessel (MV) and 20 ± 1.5 atm (range 20–25) in SB. Simultaneous final kissing balloon was used in 92% of cases. PCI was successful in 100%. Angiographic follow-up was obtained in 83% of patients. Restenosis rate was 13% (12% restenosis in the SB) with only one case (0.8%) of SB probable thrombosis. Another case of late stent thrombosis occurred at a 3 years clinical follow-up. Conclusion Compared with previously published studies in which stents were deployed at lower pressure, SDHP does not increase the restenosis rate in BL using mini-crush stent technique but seems to reduce the rate of stent thrombosis.

Introduction A lack of information about the feasibility and safety of leadless pacemaker (LPMs) exists in a fragile population of patients with limited venous anatomy access or conventional pacemaker (PM) contraindication. Accordingly, the goal of this prospective observational study was to report our experience with this new leadless technology in a subset of patients with contraindication or limited venous access. Methods and results Between May 2015 and July 2016, 14 patients were consecutively included. The indications for initial PM implantation were atrioventricular (AV) block in 10/14 patients (71%), bradyarrhythmia in one (7%), and uncontrolled atrial fibrillation (AFib) requiring AV-node ablation in three (21.5%). AFib was observed in 9 of the 14 patients (64.3%) and 3 were completely dependent with no escape rhythm (21.5%). Normal access pathways via the right or left subclavian veins were occluded due to previous PM implantations and revisions in 4 patients (28.6%) and total vena cava occlusion in 3 (21.4%). End-stage renal disease with hemodialysis was present in 8 (57%) with either local-device infections or presence of long-term implanted dialysis catheters. Evidence of previous bilaterally-infected pectoral tissue was present in 3 patients (21.5%). All procedures were successful (100%) and electrical parameters remained stable over time. No direct pacemaker-related adverse events were reported, including mechanical complications, except for one ventricular fibrillation one day post-implantation under very specific conditions. Conclusion This series demonstrated very stable performance and reassuring safety results during mid-term follow-up in a very fragile population requiring a PM. The Micra LPM constitutes an excellent alternative to the epicardial surgical approach in this very fragile population.

The efficacy of direct oral anticoagulants (DOACs) in the management of left ventricular (LV) thrombi remains to be determined, especially in patients with ischemic cardiomyopathy. This retrospective study sought to compare the efficacy of vitamin K antagonists (VKAs) and DOACs in patients with LV thrombi and evaluate the rate of LV thrombus resolution after adjusting anticoagulation. This observational retrospective study included patients admitted to our institution for LV thrombus between January 2010 and August 2019. The rate of LV thrombus resolution was compared between VKAs and DOACs. Patients without thrombus resolution with DOAC treatment were switched to VKA agents in order to obtain an international normalized ratio (INR) of 3–4. Between January 2010 and August 2019, 59 consecutive patients with LV thrombi detected by transthoracic echocardiography were included in the study. The mean age was 62 ± 14 years and 16.9% were women. The circumstances of LV thrombus discovery were as follows: acute myocardial infarction or ischemic myocardiopathy (n = 22), stroke (n = 6), chest pain (n = 7), heart failure (n = 11), transthoracic echocardiographic evaluation (n = 11), and ventricular arrhythmias (n = 2). The proportion of patients on DOACs was 28.8% (n = 17), while that of those on VKAs was 71.2% (n = 42). Thrombus resolution was obtained in 70.6% (12/17) of patients on DOACs and in 71.4% (30/42) of those on VKAs (p = 0.9). Patients who failed to respond to DOAC treatment were treated with VKAs, and following this treatment adjustment all LV thrombi were dissolved in the DOAC group (5/5). Five embolic events (8.4% of stroke) occurred before the treatment initiation and six with anticoagulants (2/17 with DOACs [11.8%] and 4/42 with VKAs [9.5%]; p = 0.8). This retrospective observational study found a similar efficacy between DOAC and VKA agents in patients with LV thrombi (70.6% vs. 71.5%); however, when the thrombus remains, VKAs are still the standard of care as it is possible to control INR levels (3–4) with them.

Interest is growing in the clinical use of sutureless (SU) valves. However, indications in some anatomical sub-settings, like bicuspid aortic valves (BAV), have been so far limited. We discuss herein our initial experience with the implantation of the 3f Enable SU bioprosthesis in patients with a BAV. Patients with a BAV were selected in our unit between March 2011 and September 2014 for a SU 3f Enable valve implantation. Twenty of the 198 patients who underwent a 3f Enable valve implantation in our unit had a BAV. Procedural success was 100 %, but reclamping was necessary in one (5 %) case. Median size of implanted bioprosthesis was 23 mm. After a mean follow-up of 13.8 ± 10.7 months, survival was 100 %. Two patients (10 %) showed an immediate grade 1 paravalvular leak (PVL) that progressed to grade 2 and 3+ (moderate/severe), respectively, during follow-up. Type of bicuspidy (Sievers classification) in these two patients was 0 and intraoperatively aortic annuli admitted the 25 mm calibrator. Among the 18 patients without PVL, no one had a type 0 large BAV. At 1 year, implantation of the 3f Enable SU bioprosthesis appears to be safe in patients with BAV type I and II, while in type 0 use of the SU valve seems to be safe only if the annular diameter is

Background and Aim We present our experience in the use of the sutureless valve in patients undergoing aortic valve replacement for pure aortic regurgitation. Methods Out of 167 patients who underwent sutureless aortic valve implantation with a Medtronic 3f Enable prosthesis in our unit between March 2011 and February 2014, 12 (7.1%) received a sutureless valve for pure aortic regurgitation. Results Mean age, logistic EuroSCORE, and left ventricular ejection fraction were 72 ± 5 years, 6.3 ± 2.9%, and 52.5 ± 15.3%, respectively. The sutureless valve could be successfully implanted in all cases; nine patients had a full sternotomy (associated coronary artery bypass graft in four cases and associated mitral surgery in five), one patient had a ministernotomy, and two had a thoracoscopic approach. Average cross-clamping and cardiopulmonary bypass times were 90 ± 30 and 127 ± 51 minutes, respectively. At the outpatient echocardiography, average mean gradient was 10.54 ± 4.99 mmHg and a grade I–II paravalvular leakage (PVL) was detected in the first patient of the cohort (ministernotomy approach). At a mean follow-up of 11.1 ± 5.5 months, average mean gradient was 9.75 ± 2.87 mmHg, no new PVL was detected, and the known PVL was stable. No pacemaker implantation was required. Conclusions Implantation of the 3f Enable sutureless valve is technically possible with pure aortic regurgitation in selected patients. Multicenter investigations are necessary to assess the mid-term benefits of such a device in this subset of patients.

Summary Background Radiofrequency ablation (RFA) of paroxysmal atrial fibrillation (PAF) has focused on pulmonary vein isolation (PVI). However, despite initial positive results, significant recurrences have occurred, partly because of pulmonary vein (PV) reconnection or non-PV ectopic foci, including the superior vena cava (SVC). Objectives This prospective, randomized study sought to investigate the efficacy of additional SVCI combined with PVI in symptomatic PAF patients referred for ablation. Methods From November 2011 to May 2013, RFA was performed remotely using a CARTO® 3 System in patients randomized to undergo PVI for symptomatic drug-refractory PAF, with (PVI + SVCI group) or without (PVI alone group) SVCI. PVI and SVCI were confirmed by spiral catheter recording during ablation. Procedural data, complications and freedom from atrial tachycardia (AT) and atrial fibrillation (AF) were assessed. Results Over an 18-month period, 100 consecutive patients (56 ± 9 years; 17 women) with symptomatic PAF were included in the study (PVI + SVCI, n = 51; PVI, n = 49); the CHA2DS2-VASc score was 0.9 ± 1. Median duration of procedure (± interquartile), 2.5 ± 1 hours; total X-ray exposure, 13.3 ± 8 minutes; transseptal puncture and catheter positioning, 8 ± 5 minutes; left atrium electroanatomical reconstruction, 3 ± 2 minutes; and catheter ablation, 3.7 ± 3 minutes. After a median follow-up of 15 ± 8 months, and having undergone a single procedure, 84% of patients were symptom free, while 86% remained asymptomatic after undergoing two procedures. The cumulative risks of atrial arrhythmias (AT or AF) were interpreted using Kaplan-Meier curves and compared using the log-rank test. Long-term follow-up revealed no significant difference between groups, with atrial arrhythmias occurring in six (12%) patients in the PVI + SVCI group and nine (18%) patients in the PVI alone group (P = 0.6). One transient phrenic nerve palsy and one phrenic nerve injury with partial recovery occurred in the PVI + SVCI group. Conclusions SVCI combined with PVI did not reduce the risk of subsequent AF recurrence, and was responsible for two phrenic nerve injuries. Accordingly, the benefit-to-risk ratio argues against systematic SVCI.

Background - Transcatheter aortic valve replacement (TAVR) is standard therapy for patients with severe aortic stenosis who are at high surgical risk. However, national data regarding procedural characteristics and clinical outcomes over time are limited. Objectives - The aim of this study was to assess nationwide performance trends and clinical outcomes of TAVR during a 6-year period. Methods - TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. Findings were further compared with those reported from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers. Results - A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. The median age of patients was 84.6 years, and 49.7% were men. FRANCE TAVI participants were older but at lower surgical risk (median logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE]: 15.0% vs. 18.4%; p < 0.001). More than 80% of patients in FRANCE TAVI underwent transfemoral TAVR. Transesophageal echocardiography guidance decreased from 60.7% to 32.3% of cases, whereas more recent procedures were increasingly performed in hybrid operating rooms (15.8% vs. 35.7%). Rates of Valve Academic Research Consortium-defined device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001). In-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively, in FRANCE TAVI compared with 8.2% and 10.1%, respectively, in FRANCE 2 (p

Summary Background Catheter ablation of atrial fibrillation (AF) focuses on pulmonary vein isolation (PVI), but the procedure is associated with significant X-ray exposure. Few data exist concerning the combination of remote magnetic navigation (RMN) and a new three-dimensional non-fluoroscopic navigation system (Carto ® 3), which facilitates precise catheter navigation and limits X-ray exposure. Aims To assess the efficacy and extent of fluoroscopic exposure associated with the combination of RMN and the Carto 3 system in patients requiring AF ablation. Methods Between January and September 2011, catheter ablation was performed remotely using the Carto 3 system in 81 consecutive patients who underwent PVI for symptomatic drug-refractory AF. The radiofrequency generator was set to a fixed power ≤ 35 W. The primary endpoint was wide-area circumferential PVI confirmed by spiral catheter recording during ablation and including additional lesion lines (left atrial roof and coronary sinus defragmentation) or complex fractionated atrial electrograms for persistent AF. Secondary endpoints included procedural data, complications and freedom from atrial tachycardia (AT)/AF. Results Mean age was 60 ± 9 years; 20% were women; 73% had symptomatic paroxysmal AF; 27% had persistent AF. The CHA 2 DS 2 -VASc score was 1.2 ± 1. Median procedure time was 3.5 ± 1 hours; median total X-ray exposure time was 13 ± 7 minutes; transseptal puncture and catheter positioning took 8 ± 4 minutes, left atrium electroanatomical reconstruction 1 ± 4 minutes and catheter ablation 3.5 ± 5 minutes. Recurrences were AT ( n = 3; 3.7%), paroxysmal AF ( n = 8; 9.9%) and persistent AF ( n = 4; 4.9%); redo ablation was performed in these 15 (19%) patients. After a median follow-up of 15 ± 6 months and a single procedure, 71% of patients were free of symptoms; 84% remained asymptomatic after two procedures. Conclusions RMN with irrigated catheters combined with the Carto 3 system can be effectively performed in patients requiring AF ablation with minimal use of fluoroscopy, but larger randomized studies are warranted.

SummaryExperimental and clinical studies have shown that right ventricular apical pacing may result in long-term deleterious effects on account of its negative impact on left ventricular remodeling through desynchronization. This risk appears more pronounced in patients with even moderate left ventricular dysfunction and generally occurs after at least 1 year of pacing. As right ventricular apical pacing may be associated with the development of organic mitral insufficiency, other sites that allow for more physiological stimulation, such as right ventricular outflow tract septal pacing, have been developed, with good feasibility and reproducibility. However, the prospective randomized studies and meta-analyses to date have only demonstrated a modest effect on ejection fraction in the medium term, without any significant effect on quality of life and morbimortality. However, the absence of a favorable effect for right ventricular outflow tract septal pacing compared with right ventricular apical pacing in terms of clinical manifestations and patient prognosis appears to be more associated with the designs of these studies, which were not homogeneous with regard to methodology used, judgment criteria, follow-up and, especially, statistical power. Two randomized prospective multicentre studies are currently ongoing in order to evaluate the favorable effect of infundibular septal pacing, when considering the indirect negative effects of right ventricular apical pacing as reported in the literature.

The prevalence and management of left atrial appendage (LAA) thrombi associated with new anticoagulants remain to be elucidated, especially prior to atrial fibrillation (AFib) ablation. This study sought to (1) compare the prevalence of LAA thrombi and/or severe LAA contrast under vitamin K antagonist (VKA) agents and novel oral anticoagulants (NOACs), (2) evaluate the rate of LAA thrombus resolution after anticoagulation modification, and (3) determine the predictive factors of LAA thrombi and severe LAA contrast in patients prior to LA AFib ablation.Between January 2013 and March 2016, 576 consecutive patients referred for AFib ablation were included, and the prevalence of transesophageal echocardiography-detected thrombi was similar under NOACs (2.1%) and VKA agents (2.6%).Thrombus resolution was obtained in 50% of cases following anticoagulation modification. Through multivariate exact logistic regression analysis with relevant clinical and echocardiographic features, age (P.001), LAA hypocontractility (P.001), and left ventricular ejection fraction (P=.007) were found to be independently associated with the occurrence of LAA thrombus. The relevant factors independently associated with LAA thrombus or severe contrast were LAA hypocontractility (P.001) and age (P.001).The prevalence of transesophageal echocardiography-detected thrombi in patients referred for AFib ablation is similar under NOACs (2.1%) and VKA agents (2.6%). Under VKA therapy with 3-4 international normalized ratio, 50% of thrombi dissolved. Independent predictive factors of procedure contraindication included age, LAA hypocontractility, and left ventricular ejection fraction.

Radiofrequency treatment represents the first choice of treatment for arrhythmias, in particular complex arrhythmias and especially atrial fibrillation, due to the greater benefit/risk ratio compared to antiarrhythmic drugs. However, complex arrhythmias such as atrial fibrillation require long procedures with additional risks such as X-ray exposure or serious complications such as tamponade. Given this context, the treatment of arrhythmias using robotic magnetic navigation entails a technique well suited to complex arrhythmias on account of its efficacy, reliability, significant reduction in X-ray exposure for both patient and operator, as well as a very low risk of perforation. As ongoing developments will likely improve results and procedure times, this technology will become one of the most modern technologies for treating arrhythmias. Based on the literature, this review summarizes the advantages and limitations of robotic magnetic navigation for ablation of human arrhythmias.

Factors of restenosis after percutaneous coronary intervention (PCI) for chronic total coronary occlusion (CTO) have not been fully explored. In particular, although the last ACC/AHA guidelines on PCI suggest that a minimum diameter stenosis of 10% with an optimal goal of as close to 0% as possible should be the new benchmark for lesions treated by stenting, angiographic success of PCI for CTO remains in the literature most often defined as a30% residual diameter stenosis. Whether an optimized immediate post-PCI angiographic result (OAR) defined by a minimal diameter stenosis as close to 0% is associated with a lower restenosis rate in this subset of coronary lesions remains unknown.Therefore, we assessed by quantitative coronary analysis (QCA) both the immediate post-PCI and 6-month follow-up angiographic results of 170 successfully treated true CTO.Post-PCI QCA immediate residual diameter stenosis was30% in all 170 CTOs and OAR defined as a ≤10% residual stenosis was achieved in 133 (78%). Global binary restenosis rate was 21% in the 170 lesions. Restenosis rates were 46% and 14% in the non-OAR group and in the OAR group, respectively (p0.0001). Multivariate analysis showed that a non-OAR, a younger age and a retrograde approach were independent factors of restenosis.Thus, an optimized immediate angiographic result with a minimal diameter stenosis as close to 0% as possible appears to be associated with a lower rate of restenosis after CTO PCI.

Background— Delayed stent implantation after restoration of normal epicardial flow by a minimalist immediate mechanical intervention aims to decrease the rate of distal embolization and impaired myocardial reperfusion after percutaneous coronary intervention. We sought to confirm whether a delayed stenting (DS) approach (24–48 hours) improves myocardial reperfusion, versus immediate stenting, in patients with acute ST-segment–elevation myocardial infarction undergoing primary percutaneous coronary intervention. Methods and Results— In the prospective, randomized, open-label minimalist immediate mechanical intervention (MIMI) trial, patients (n=140) with ST-segment–elevation myocardial infarction ≤12 hours were randomized to immediate stenting (n=73) or DS (n=67) after Thrombolysis In Myocardial Infarction 3 flow restoration by thrombus aspiration. Patients in the DS group underwent a second coronary arteriography for stent implantation a median of 36 hours (interquartile range 29–46) after randomization. The primary end point was microvascular obstruction (% left ventricular mass) on cardiac magnetic resonance imaging performed 5 days (interquartile range 4–6) after the first procedure. There was a nonsignificant trend toward lower microvascular obstruction in the immediate stenting group compared with DS group (1.88% versus 3.96%; P =0.051), which became significant after adjustment for the area at risk ( P =0.049). Median infarct weight, left ventricular ejection fraction, and infarct size did not differ between groups. No difference in 6-month outcomes was apparent for the rate of major cardiovascular and cerebral events. Conclusions— The present findings do not support a strategy of DS versus immediate stenting in patients with ST-segment–elevation infarction undergoing primary percutaneous coronary intervention and even suggested a deleterious effect of DS on microvascular obstruction size. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01360242.

Objectives: To propose an original approach based on simultaneous dual vascular access site (DAS) using 2 small-size guiding catheters to easily perform complex 2-stent techniques for bifurcation coronary lesions (BL). Background: Simultaneous kissing stenting and classic crush technique require large 7 or 8Fr guiding catheters leading to large amounts of contrast medium, vascular access site complications, and sometimes frictions or criss-cross of the 2-stent delivery systems. Methods: DAS was used in 30 patients with BL (11 radio-radial, 16 radio-femoral, and 3 femoro-femoral). Among 60 guiding catheters, the size was 5Fr in 28, 6Fr in 30, and 7Fr in 2 cases of double adjacent BL. When 2 different size catheters were used, contrast medium injections were done using the smallest size catheter. DAS patients were compared with a group of 30 BL patients treated using a single femoral vascular access site (SAS) with 7 or 8Fr catheters. Results: Success rate was 100% in all patients. Contrast volume used was smaller in DAS than in SAS patients (277 ± 156 cc vs. 380 ± 165 cc,P = 0.01). No vascular access site complication occurred in the sub-group of the 11 DAS radio-radial patients. Postintervention hospitalization duration was shorter in DAS than in SAS (1.9 ± 2 vs. 2.8 ± 2 days,P = 0.048). Conclusion: DAS allows to successfully perform complex stenting technique of BL using small-size guiding catheters leading to decreased contrast medium volume, decreased vascular access site complications rates, and shortened hospitalization duration. (J Interven Cardiol 2012;25:439–446)

Summary Background The reported failure rate of the Sprint Fidelis defibrillator lead (SFDL) has increased more than initially expected, with emerging evidence of accelerating fracture rates. Current consensus guidelines continue to discourage prophylactic lead extraction, citing major complication rates of 1.4–7.3%. Therefore, data relating to the risks of systematic SFDL extraction are lacking, with no methodical extraction protocol reported to date. Moreover, few statistical analyses have identified predictors of SFDL failure. Objectives The aims of this single-centre study were: to examine the safety and feasibility of systematic SFDL extraction at the time of pulse generator replacement or in case of lead failure; and to identify predictors of SFDL failure. Methods Between January 2005 and October 2007, 218 consecutive patients underwent transvenous SFDL implantation in our centre. Results During a mean follow-up of 43 ± 15 months, SFDL extraction was performed in 49 patients (22.5%) for the following reasons: inappropriate shocks ( n = 21; 9.6%), systematic extraction at time of pulse generator extraction ( n = 23; 10.5%), high impedance ( n = 3; 1.4%), high SFDL threshold ( n = 1; 0.4%) and cardiac device-related infection ( n = 1; 0.4%). No severe complications occurred, although two minor complications were reported (lead dislodgments). SFDL fracture was observed in 25 patients (11.5%; 3.2%/year incidence). The only predictor associated with SFDL fracture was the number of leads ( P = 0.01). Conclusion In our series, SFDL extraction at the time of pulse generator extraction or in case of evidence of lead failure was feasible and safe. Number of leads was identified as a new predictive factor for SFDL fracture.

Summary Background Radiofrequency ablation (RFA) of outflow tract ventricular ectopic beats (OTVEBs) can be performed using a 4-mm or externally-cooled tip RFA catheter, but no data are available concerning the safety and efficacy of a large-tip (8-mm) catheter. Aims To evaluate the feasibility of using an 8-mm tip catheter in patients with OTVEBs. Methods In this prospective cohort study, the 8-mm tip catheter was tested in patients who were referred to our centre for RFA of symptomatic OTVEBs. Results The mean age of the 16 patients recruited between September 2008 and March 2010 was 53 ± 18 years and 56.3% were male. Mean left ventricular ejection fraction was 62 ± 9%, mean ventricular ectopic beat width was 144 ± 21 ms, and all patients had left bundle branch block. Fourteen patients had inferior axis QRS morphology and two had superior. The main symptoms were palpitations and pre-syncope. RFA parameters were: procedure time 94 ± 35 min; duration of application 11 ± 10 min; impedance 81 ± 12 Ω; temperature 50 ± 5 °C; and power 46 ± 17 W. RFA succeeded in 15 over 16 patients (93.8%); and recurrence was seen in one patient after a mean follow-up time of 11 ± 6 months. No complications were noted. Conclusions This preliminary study suggests that an 8-mm tip catheter may represent an alternative for RFA in patients with OTVEBs in whom a 4-mm tip was not successful. Larger randomized studies are therefore warranted.

Aims In cardiac resynchronization therapy (CRT) procedure, left ventricular (LV) lead implantation is time consuming. In this clinical setting, no study has investigated the impact of right atrium anatomical parameters on both CRT implantation procedure duration and X-ray exposure. Additionally, only few studies have examined the coronary sinus (CS) using dual-source 64-multi-slice computed tomography (DS 64-MSCT), and its impact on CRT procedure parameters has not yet been investigated. The aim of this prospective study was to identify local anatomical predictive factors of difficult CRT implantation procedure using DS 64-MSCT. Methods and results Between January and July 2010, 50 consecutive patients underwent primo CRT implantation. The patient population had a mean age of 70 ± 10 years, and was 34% female, with New York Heart Association Class 3.2 ± 0.3 heart failure, left ventricle ejection fraction 30 ± 4%, and QRS width 157 ± 30 ms. Cardiac resynchronization therapy implantation was attempted in 50 patients, and first LV lead implantation was obtained in 49 of 50 patients (98% primary success). One implantation failed (2%) due to unsuccessful LV lead implant. Procedure parameters were as follows: LV threshold, 1.4 ± 0.8 V; LV wave amplitude, 17 ± 8 mV; LV impedance, 830 ± 240 Ω; median procedure time (skin to skin), 51 min (38 min); median fluoroscopy procedure time, 11.9 min (22 min); and median LV fluoroscopic time, 10.3 min (22 min). In 10 patients (20%), procedures were difficult requiring an implantation lasting ≥85 min. The only predictive factor for difficult CRT implantation was the insertion level of the CS ostium (CSO), evaluated by the distance between the CSO and the bottom floor of the right atrium (14.8 ± 4 vs. 9.5 ± 4; P = 0.01). Neither the right atrium dilation nor right ventricular dysfunction was associated with difficult CRT implantation procedures. Conclusions Today, despite improvements in the materials used, problems still remain in the CRT procedure. In this clinical setting, the only predictive factor for very long CRT procedures is the CSO-level insertion (located high). This anatomical anomaly identified by DS 64-MSCT prior to surgery is responsible for 20% of difficult CRT device implantation procedures.

Aims The usefulness of cardiac resynchronization therapy (CRT) in patients with congestive heart failure is offset by its long, user-dependent, and technical procedure. No studies have been published regarding factors related to CRT implantation procedure duration and X-ray exposure. Additionally, only a few studies have investigated the predictive factors of primary left ventricular (LV) lead implant failure. The aim of this prospective study was two-fold: (i) to evaluate the prevalence and predictive factors of prolonged CRT implantation procedure and (ii) to identify the predictive factors of primary LV lead implantation failure. Methods and results Between November 2008 and September 2009, 128 consecutive patients underwent CRT implantation; of these, 22 patients (17.2%) were excluded because of CRT generator replacement. Population characteristics were a mean age of 69 ± 10 years, 28.3% female, New York Heart Association class 3.2 ± 0.3, LV ejection fraction (LVEF; 29 ± 6%), and QRS width 146 ± 23 ms. Cardiac resynchronization therapy implantation was attempted in 106 patients, and first LV lead implantation was obtained in 96 of 106 patients (90.5% primary success). Ten primary implantations failed (9.5%), due to unsuccessful LV lead implants. A second procedure was successfully attempted in six patients with a second more experienced operator (5.7%). Among the remaining four patients, one patient required a surgical epicardial LV lead implantation, and the implantation was not reattempted in the other three patients. The overall success rate of CRT system implantation was 96.2% (102 of 106 patients). Procedure parameters were as follows: LV threshold (1.4 ± 0.9 V); LV wave amplitude (15 ± 8 mV); LV impedance (874 ± 215 ohm); median procedure time (skin to skin), 55 min (45–80); and median of procedure fluoroscopy time, 11 min (6.2–29). In 24 patients (22.6%), difficult procedures requiring ≥85 min of implantation duration occurred. By univariate analysis, predictive factors of difficult implantation were LV ejection fraction (25.6 ± 6 vs. 30.2 ± 8%; P = 0.02), LV end-diastolic diameter (72.4 ± 11 vs. 66 ± 11 mm; P = 0.01), LV end-systolic diameter (LVESD; 62 ± 12 vs. 56 ± 12 mm, P = 0.04), and the operator's experience (very experienced operator vs. less experienced operator, P = 0.006). By multivariate analysis, only primary LV lead implantation failure, LVESD, and operator's experience were independently associated with difficult procedures. In this patient subset with primary LV lead implant failure ( n = 10), the only independent predictive factor was the LV end-systolic volume ( P = 0.03). Conclusion In this study, the rate of difficult CRT device implantation procedures approached 25%. Both the degree of LV dysfunction and the operator's experience were independent predictors of surgical difficulties. Left ventricular end-systolic volume was the only independent predictor of primary LV lead implant failure.

Summary Background Previous studies have evaluated return to work after acute ST-segment elevation myocardial infarction (STEMI) treated medically, after bypass surgery or after percutaneous coronary intervention (PCI) for stable coronary artery disease. However, there are few data regarding return to work after acute STEMI treated by direct PCI. Aims To analyse the factors influencing return to work after STEMI treated by direct PCI. Methods Two hundred consecutive patients who underwent direct PCI for acute STEMI and who were employed at the time of their STEMI were studied. Stents were used in 94% of patients and glycoprotein IIb/IIIa inhibitors in 77%. Results Among the 200 patients, 152 (76%) patients returned to work and 48 (24%) did not. Patients who did not return to work did not differ from those who returned to work in terms of time from onset of chest pain to PCI, STEMI location, left ventricular function, extent of vessel disease, PCI technique and success, completeness of revascularization, duration of hospital stay, intrahospital complications and performance of cardiac rehabilitation. Multivariable analysis showed that older age, daytime onset of chest pain, manual labour, rapid call-out of the emergency medical team, unmarried status and a limited number of risk factors were independent predictors of non-return to work. Conclusion Age, sociopsychological and occupational factors appear to be the strongest predictors of return to work after STEMI treated by direct PCI. Clinical and procedural factors as well as cardiac rehabilitation appear to have no impact on return to work in this subset of patients.

The COMPASS trial applied trial-specific high risk criteria. We sought to determine whether 3-year mortality in a routine-practice population would differ according to the inclusion and exclusion criteria used in COMPASS. We used data from the FAST-MI 2005 and 2010 registries, restricted to

Our case reports the first migration of a stent already deployed at high pressure in the main vessel during a 2-stent strategy for a bifurcation lesion using T and protrusion technique. The Kissing balloon was not optimal and could have led to an insufficient strut/cell opening and then to LAD stent pulled back into the artery tree. This case report highlights the importance of an optimal Kissing Balloon in two stent bifurcation technique.

We present our experience in the use of the sutureless valve in patients undergoing aortic valve replacement for pure aortic regurgitation.Out of 167 patients who underwent sutureless aortic valve implantation with a Medtronic 3f Enable prosthesis in our unit between March 2011 and February 2014, 12 (7.1%) received a sutureless valve for pure aortic regurgitation.Mean age, logistic EuroSCORE, and left ventricular ejection fraction were 72 ± 5 years, 6.3 ± 2.9%, and 52.5 ± 15.3%, respectively. The sutureless valve could be successfully implanted in all cases; nine patients had a full sternotomy (associated coronary artery bypass graft in four cases and associated mitral surgery in five), one patient had a ministernotomy, and two had a thoracoscopic approach. Average cross-clamping and cardiopulmonary bypass times were 90 ± 30 and 127 ± 51 minutes, respectively. At the outpatient echocardiography, average mean gradient was 10.54 ± 4.99 mmHg and a grade I-II paravalvular leakage (PVL) was detected in the first patient of the cohort (ministernotomy approach). At a mean follow-up of 11.1 ± 5.5 months, average mean gradient was 9.75 ± 2.87 mmHg, no new PVL was detected, and the known PVL was stable. No pacemaker implantation was required.Implantation of the 3f Enable sutureless valve is technically possible with pure aortic regurgitation in selected patients. Multicenter investigations are necessary to assess the mid-term benefits of such a device in this subset of patients.

Aims Radiofrequency ablation (RFA) of cavotricuspid isthmus (CTI)-dependent atrial flutter can be performed using various types of ablation catheters. Recent evaluations comparing externally cooledtip RFA (ecRFA) catheters and large-tip (8 mm) catheters found that ecRFA catheter may have a higher efficacy for CTI ablation. The aim of this prospective study was to compare both catheters by stratifying on CTI morphology in order to explain, in part, the discrepancies between previous randomized studies, and to validate predictive factors of difficult CTI ablation on clinical, echocardiographic, and angiographic data. Methods and results Over a period of 24 months, 281 patients were included and stratified on CTI morphology: ‘straight’, ‘concave’, and ‘pouch-like recess’. In straight CTI (n ¼ 150), the duration of application time with a median of 6 min [interquartile range (IQR) 4–9] vs. a median of 12 min (IQR 16–19; P , 0.0001) and the duration of X-ray exposure with a median of 6 min (IQR 4.4–9.7) vs. a median of 10.4 min (IQR 7–17; P , 0.0001) were significantly lower with an 8 mm-tip when compared with ecRFA catheter. In contrast, in concave CTI (n ¼ 95), a trend towards both shorter application time with a median of 12.5 min (IQR 6–23) vs. a median of 19 min (IQR 7–28; P ¼ 0.08) and X-ray duration exposure with a median of 10.4 min (IQR 6–20) vs. a median of 13 min (IQR 8–24; P ¼ 0.08) with an ecRFA catheter when compared with 8 mm-tip catheter were evidenced. No significant difference was shown between 8 mm-tip and ecRFA catheters in the pouch-like recess group (n ¼ 36). Predictive factors of difficult ablation include right CTI length and morphology. Conclusion This study demonstrates that the 8 mm-tip catheter is more effective for ablation in case of a straight angiographic isthmus morphology and that the ecRFA catheter tends to be more effective in case of concave angiographic isthmus morphology. Thus, angiographic isthmus evaluation may predict both the effectiveness of an RF catheter, and the risk of an expensive crossover. These data may explain, in part, the discrepancies of previous studies comparing both catheters.

AIMS The purpose of this study was to evaluate the efficacy, risks, safety, and follow-up of radiofrequency (RF) catheter ablation of atrioventricular nodal re-entrant tachycardia (AVRNT) in patients (pts) > or = 75 years old (n=42) (GpI) compared with pts younger than 75 years (n=234) (GpII). METHODS AND RESULTS The study population consisted of 276 consecutive pts (39.5% men/60.5% women), from 15 to 98-year-old (average 56+/-17 years) with AVRNT referred for RF ablation (RFA) from October 1997 to January 2004. Combined anatomical and electrogram approaches were used to guide RFA. The cumulative risk of AVRNT recurrence was analysed by the Kaplan-Meier method and log-rank test. The average follow-up was 34+/-18 months. GpI (80+/-4 years) differed significantly from GpII (51+/-14 years) regarding: heart rate tachycardia (160+/-20 vs. 180+/-30 bpm; P=0.0001), the slow pathway antegrade refractory period (370+/-70 vs. 340+/-60 ms; P=0.01), the fast pathway antegrade refractory period (360+/-60 vs. 330+/-60 ms; P=0.003), retrograde refractory period (360+/-60 vs. 330+/-60 ms; P=0.0007), left ventricular ejection fraction (60+/-12 vs. 65+/-7%; P=0.0009), and ischaemic ECG signs during tachycardia (76.2% vs. 61%; P=0.09). RFA was successfully obtained in 275/276 (99.6%), 42/42 in GpI (100%), and 233/234 (99.6%) in GpII. Five complications occurred (1.8%): major complications in two pts (0.7%) and minor complications in three pts (1.1%). Major complications were deep venous thrombosis with pulmonary embolus (n=1) and pericardial effusion (n=1), minor complications were groin haematoma (n=3). One complication was observed in GpI (groin haematoma) (2.4%) and four in GpII (deep venous thrombosis with pulmonary embolus in one, groin haematoma in two, and pericardial effusion in one) (1.7%). The number of recurrences was not statistically different between the two groups (0 vs. 3.4%; P=0.5) with a respective average follow-up of 28+/-18 and 35+/-18 months, respectively. CONCLUSION Catheter ablation of AVRNT in elderly and very elderly pts appears to be a reasonable approach regarding feasibility and effectiveness without increasing the risk of AV block.

Whether chronic typical atrial flutter differs from paroxysmal atrial flutter regarding electrophysiological properties of reentry pathways and cardiac function remains unknown. If so, can remodeling due to long duration of persistently rapid atrial or ventricular rates explain these changes? The aim of the study was to compare RA local conduction velocities and heart function parameters between three groups: (1) chronic atrial flutter, (2) paroxysmal atrial flutter, and (3) controls. The study evaluated 52 patients undergoing radiofrequency ablation for typical atrial flutter. There were 35 patients with chronic atrial flutter (62.7 +/- 14 years) and 17 patients with paroxysmal atrial flutter (62.7 +/- 10 years). Underlying structural heart disease was present in 20 (57%) of 35 chronic atrial flutter patients and in 7 (41%) of 17 paroxysmal atrial flutter patients (P = 0.1). Chronic atrial flutter duration was 10.9 +/- 17 months and paroxysmal atrial flutter duration was 8.5 +/- 10 (P = 0.06). RA conduction velocity measurements were carried out before ablation during sinus rhythm under pacing (600-ms cycle length) with a 12-pole steerable catheter positioned in the high lateral RA (poles 11-12 [H6]), mid-lateral RA (poles 9-10 [H5]), and along the inferior vena caval tricuspid isthmus (poles 7-8 [H4]; 5-6 [H3]; 3-4 [H2]) with its distal electrode pair at the coronary sinus origin (pole 1-2 [H1]). Counter-clockwise RA conduction velocities were assessed from H6 to H1 and clockwise RA conduction velocities from H1 to H6. After successful ablation, RA and LA areas, LV volumes, LVEF, inferior vena caval tricuspid annulus, and coronary sinus tricuspid annulus (septal isthmus) lengths were measured by two-dimensional echocardiography. The control group included 12 patients without structural heart disease, referred for electrophysiological evaluation of AVN reentry. Counter-clockwise RA conduction velocities at the inferior vena caval tricuspid isthmus were lower in chronic atrial flutter than in paroxysmal atrial flutter (H4, 1.19 +/- 0.4 vs 1.89 +/- 1 m/s, P = 0.0051; H3, 1.14 +/- 0.4 vs 1.6 +/- 0.7 m/s, P = 0.0015; H2, 1.16 +/- 0.4 vs 1.53 +/- 0.5 m/s, P < 0.0056 and H1, 1.2 +/- 0.4 vs 1.5 +/- 0.4 m/s, P = 0.03, respectively). Counter-clockwise RA conduction velocities were identical at the high and mid-lateral RA. Counter-clockwise caval isthmus RA conduction velocities from H3 to H1 were significantly different between chronic atrial flutter and controls (H3, 1.14 +/- 0.4 vs 1.7 +/- 0.3 m/s, P = 0.0014; H2, 1.16 +/- 0.4 vs 1.83 +/- 0.4 m/s, P < 0.0001 and H1, 1.2 +/- 0.4 vs 1.94 +/- 0.4 m/s, P < 0.0001, respectively). A difference was found regarding clockwise isthmus RA conduction velocities between the two groups of atrial flutter and controls but not between chronic atrial flutter and paroxysmal atrial flutter. Respectively, chronic atrial flutter had greater RA and LA areas (24.5 +/- 5 vs 13 +/- 2 cm2; P < 0.0001 and 23 +/- 5 vs 16 +/- 3 cm2, P < 0.0001), LV end-systolic and end-diastolic volumes (50 +/- 25 vs 32 +/- 13 cm3, P = 0.0084 and 112 +/- 40 vs 85 +/- 25 cm3, P = 0.01), septal isthmus length (21 +/- 3 vs 13 +/- 2 mm, P < 0.0001), and inferior vena caval tricuspid isthmus length (39 +/- 6 vs 23 +/- 5 mm; P < 0.0001). Chronic common atrial flutter is characterized by more prolonged counter-clockwise conduction times and larger anatomic conduction pathways than the paroxysmal form, the causal relationship between electrophysiological and anatomic characteristics remains to be demonstrated.

Type and dose of daily energy expenditure (DEE) play a major role in modulations of health status and an increased knowledge of these dimensions of physical activity in congestive heart failure (CHF) patients would be valuable for clinical and epidemiological aims. We propose a new self-administered DEE questionnaire adapted to CHF patients and tested its validity. One hundred and five stable CHF participants, NYHA class I-IV, LVEF=33.2+/-6.1% performed an incremental symptom-limited Vo(2) (peak) test and filled in the questionnaire for DEE calculation. Reproducibility (n=24), sensitivity (n=21) of the questionnaire and inter-observer variability (n=105) were tested. Intensity levels were identified from DEE and their relationships to Vo(2)(peak), ventilatory and anthropometric characteristics were assessed by simple and multiple regression models. Reproducibility and sensitivity were high (r=0.98 and 0.88, respectively, P0.0001) and inter-observer error reached 1.37%. DEE was highly correlated to physical activity energy expenditure (r=0.96, P0.0001). Relationships between DEE, Vo(2)(peak), V(E)/Vo(2) and anthropometric characteristics were significant. An activity level above 3 MET was the best intensity criteria related to Vo(2)(peak) (r=0.62, P0.0001) and DEE (r=0.80, P0.0001). The questionnaire seems reproducible, sensible and valid for DEE estimation. Vo(2)(peak) appears related to DEE and especially to activities above 3 MET in CHF.

SummaryThe prognosis of patients with myocardial infarction (MI) and normal coronary arteries (NCA) in the presence of an inherited coagulation disorder is unknown. The purpose of this study was to compare the clinical thrombosis outcome of patients with (GpI) or without (GpII), inherited coagulation disorders, who suffered from an acute MI with NCA. Eighty two consecutive patients (mean age 49 ± 15 years; 29 females) with MI, but NCA, were recruited. Twelve patients (15%) had an inherited coagulation disorder. GpI and GpII were statistically similar regarding age (45 ± 11 vs 50 ± 16 years-old), gender (33 vs. 36% female), tobacco consumption (50 vs. 53%), diabetes mellitus (8 vs. 10%), hypertension (25 vs. 17%), obesity (8.3 vs. 14%), family history of coronary heart disease (33 vs. 19%), hypercholesterolemia (50 vs. 21%; p = . 08), left ventricular ejection fraction (58 ± 13 vs. 61 ± 13%) and spasm (8.3% vs. 17%). All patients were initially treated with antiplatelet agents with the exception of one (8%) in GpI, and 6 (9%) in GpII who were taking oral anticoagulant therapy (ns). The mean follow-up was 57 ± 26 (range from 2-91 months). During the outcome, 12/78 (15.4%) thrombosis events occurred, including venous thrombosis or pulmonary embolism (1/12 vs. 1/66), reinfarction (2/12 vs. 4/66), and stroke (2/12 vs. 2/66), with two events in one patient (GpI). Kaplan-Meier event-free survival, with combined end-point, defined as venous thrombo-embolic event, reinfarction, or stroke differed between the two groups: 4/12 (33.3%) in GpI and 7/66 (10.6%) in Gp II (p Presented in part at the 52nd Annual Scientific Session of the American College of Cardiology; March 30-April 2, Chicago USA 2003, Abstract.

Little data is available concerning the invasive treatment of atrial flutter (AFL) in elderly patients. The purpose of this prospective study was to evaluate the risks, safety, and follow-up of radiofrequency (RF) catheter ablation of common AFL in patients >75 years old (n = 61) (Group I) compared to patients younger than 75 years (n = 187) (Group II). The study population consisted of 248 patients (81% men/19% women), 21 to 96 years old (mean 66.3 +/- 12 years) with AFL, referred for RF from June 1999 to June 2001. RF endpoint was the assessment of the bidirectional block. The cumulative risk of atrial fibrillation (AF) was analyzed by the Kaplan-Meier method and log-rank test. The mean follow-up was 12.4 +/- 9 months. No complication occurred. Group I (80.1 +/- 4.5 years) did not differ significantly from Group II (61 +/- 11 years) regarding: AF history before ablation (34.4% vs 39.8%), structural heart disease (54% vs 42%), LVEF (57%+/- 12% vs 58%+/- 12%), left atrial size (43.8 +/- 7 vs 42.5 +/- 7), cava-tricuspid isthmus dimension (40 +/- 10 vs 39 +/- 4 mm), bidirectional block (100% vs 96.2%), RF application (12.5 +/- 10 vs 13.5 +/- 12 minutes), AFL recurrence (3.3% vs 5.3%), antiarrhythmic agents at hospital discharge (34.4% vs 38.9%), mean follow-up (12 +/- 9 vs 13 +/- 9 months) and AF occurrence (29.5% vs 20.3%; P = 0.2). Of these, the incidence of AF in patients without prior history (n = 150) was 7 (18%) of 39 for Group I and 11 (10%) of 111 for Group II (P = 0.1) after follow-up. Catheter ablation of AFL in very elderly patients appears to be a reasonable approach regarding feasibility, effectiveness, and low procedural risk.

ROCHE, F., et al.: Frequent and Prolonged Asymptomatic Episodes of Paroxysmal Atrial Fibrillation Revealed by Automatic Long-Term Event Recorders in Patients with a Negative 24-Hour Holter. The presence, frequency, and duration of episodes of paroxysmal atrial fibrillation (PAF) is difficult to establish. This is caused by the limited duration of standard Holter recordings and to the unsatisfactory yield of patient-triggered event recorders, because of asymptomatic events and of an inconsistent use of the patient dependent triggering function. A prospective cohort of 65 consecutive patients with recurrent palpitations and a negative 24-hour ECG Holter was investigated by means of a cardiac event recorder bearing continuous automatic arrhythmia analysis and storage. Over a mean duration of 77 ± 36 hours, episodes of PAF were diagnosed in 20 (31%) patients, who had a total of 37 episodes; mean duration of PAF episodes was 7 hours 50 minutes ± 8/hours 45 minutes (minimum 45 minutes, maximum 28 hours). Eleven (55%) of these 20 patients were asymptomatic and would have remained undiagnosed without the automatic mode of the event recorder. Asymptomatic PAF episodes were longer than symptomatic ones (10 hours 30 minutes ± 6 hours 30 minutes vs 4 hours 50 minutes ± 4 hours, P < 0.05). In addition, episodes of sustained paroxysmal supraventricular tachycardia (PSVT) were diagnosed in 39 (57%) patients, of whom 34 (87%) were symptomatic. In this prospective cohort, a second standard 24-hour monitoring would have missed 44% of the patients with PAF or PSVT and a classical patient-triggered event recorder 13%. In patients still complaining of palpitations after one negative 24-hour Holter, numerous, prolonged, and often asymptomatic episodes of PAF can be revealed by long-term automatic event recorders. These devices should help clarify the clinical consequences of such episodes.

Results from randomized trials evaluating thrombus aspiration (TA) in patients with ST-elevation myocardial infarction (STEMI) are conflicting. We assessed 1-year survival in STEMI patients participating in the French Registry of Acute ST-Elevation and non–ST-Elevation Myocardial Infarction (FAST-MI) 2010 according to the use of TA during primary percutaneous coronary intervention (PCI). FAST-MI 2010 is a nationwide French registry that included 4,169 patients with acute myocardial infarction at the end of 2010 in 213 centers. Of those, 2,087 patients had STEMI, of whom 1,538 had primary PCI, with TA used in 671 (44%). Patients with TA were younger (61 ± 13.5 vs 63 ± 14 years), with a similar risk score of the Global Registry of Acute Coronary Events (140 ± 31 vs 143 ± 34) and a shorter median time from symptom onset (245 vs 285 minutes); location of acute myocardial infarction, history of myocardial infarction, PCI, or coronary artery bypass surgery did not differ significantly. Thirty-day mortality was 2.1% versus 2.1% (adjusted p = 0.18), and the rate of 1-year survival was 95.5% versus 94.8%. Using fully adjusted Cox multivariate analysis, hazard ratio for 1-year death was 1.13 (95% confidence interval 0.66 to 1.94). After propensity score matching (480 patients per group), 1-year survival was also similar with both strategies. In a real-world setting of patients admitted with STEMI, the use of TA during primary PCI was not associated with improved 1-year survival.