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

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

Comprehensive vs. standard remote monitoring of cardiac resynchronization devices in heart failure patients: results of the ECOST-CRT study.

AIMS: Integrating remote monitoring (RM) into existing healthcare practice for heart failure (HF) patients to improve clinical outcome remains challenging. The ECOST-CRT study compared the clinical outcome of a comprehensive RM scheme including a patient questionnaire capturing signs and symptoms of HF and notifications for HF specific parameters to traditional RM in patients with cardiac resynchronization therapy (CRT) devices. METHODS AND RESULTS: Patients were randomized 1:1 to standard daily RM (notification for technical parameters and ventricular arrhythmias; control group) or comprehensive RM (adding a monthly symptom questionnaire and notifications for biventricular pacing, premature ventricular contraction, atrial arrhythmias; active group). The primary endpoint was all-cause mortality or hospitalization for worsening HF (WHF). Six hundred fifty-two patients (70.4 ± 10.3 years, 73% men, left ventricular ejection fraction 29.1 ± 7.6%, 68% CRT-Defibrillators, 32% CRT-Pacemakers) were enrolled. The COVID-19 pandemic caused an early termination of the study, so the mean follow-up duration was 18 ± 8 months. No statistically significant difference in the primary endpoint was found between the groups [59 (18.3%) control vs. 77 (23.3%) active group; log-rank test P = 0.13]. Among the secondary endpoints, the MLHF questionnaire showed a larger share of patients with improvement of quality of life compared to baseline in the active group (78%) vs. control (61%; P = 0.03). CONCLUSION: The study does not support the notion that comprehensive RM, when compared to standard RM, in HF patients with CRT improves the clinical outcome of all-cause mortality or WHF hospitalizations. However, this study was underpowered due to an early termination and further trials are required. REGISTRATION: Clinical Trials.gov Identifier: NCT03012490.

Effects of hyperbaric exposure on mechanical and electronic parameters of implantable cardioverter-defibrillators.

AIMS: Hyperbaric oxygen therapy (HBOT) is the standard adjuvant treatment for life-threatening or disabling pathologies. Currently, mechanical and electronic variations of implantable cardioverter-defibrillators (ICD) in hyperbaric conditions have not been evaluated. As a result, many patients eligible for HBOT but ICD recipients cannot undergo this therapy, even in emergency situations. METHODS AND RESULTS: Twenty-two explanted ICD of various brands and models were randomized in two groups: single hyperbaric exposure at an absolute pressure of 4000 hPa and 30 iterative hyperbaric exposures at an absolute pressure of 4000 hPa. Mechanical and electronic parameters of these ICD were blindly assessed before, during, and after hyperbaric exposures. Regardless of the hyperbaric exposure, we could not find any mechanical distortion, inappropriate occurrence of anti-tachycardia therapies, dysfunction of tachyarrhythmia therapeutic programming, or dysfunction of programmed pacing parameters. CONCLUSION: Dry hyperbaric exposure seems harmless on ICD tested ex vivo. This result may lead to a reconsideration of the absolute contraindication of emergency HBOT to ICD recipients. A real-life study in these patients with an indication to HBOT should be performed to assess their tolerance to the treatment.

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.

Characterization of atrial fibrillation in real-world patients: testing the 4S-AF scheme in the Spanish and French cohorts of the EORP-AF Long-Term General Registry.

AIMS: The 4S-AF scheme [Stroke risk, Symptom severity, Severity of atrial fibrillation (AF) burden, Substrate severity] has recently been described as a novel approach to in-depth characterization of AF. We aim to determine if the 4S-AF scheme would be useful for AF characterization and provides prognostic information in real-world AF patients. METHODS AND RESULTS: The Spanish and French cohorts of the EORP-AF Long-Term General Registry were included. The baseline 4S-AF scheme was calculated and related to the primary management strategy (rhythm or rate control). Follow-up was performed at 1-year with all-cause mortality and the composite of ischaemic stroke/transient ischaemic attack/systemic embolism, major bleeding, and all-cause death, as primary endpoints. A total of 1479 patients [36.9% females, median age 72 interquartile range (IQR 64-80) years] were included. The median 4S-AF scheme score was 5 (IQR 4-7). The 4S-AF scheme, as continuous and as categorical, was associated with the management strategy decided for the patient (both P < 0.001). The predictive performances of the 4S-AF scheme for the actual management strategy were appropriate in its continuous [c-index 0.77, 95% confidence interval (CI) 0.75-0.80] and categorical (c-index 0.75, 95% CI 0.72-0.78) forms. Cox regression analyses showed that 'red category' classified patients in the 4S-AF scheme had a higher risk of all-cause death (aHR 1.75, 95% CI 1.02-2.99) and composite outcomes (aHR 1.60, 95% CI 1.05-2.44). CONCLUSION: Characterization of AF by using the 4S-AF scheme may aid in identifying AF patients that would be managed by rhythm or rate control and could also help in identifying high-risk AF patients for worse clinical outcomes in a 'real-world' setting.

Robustness and relevance of predictive score in sudden cardiac death for patients with Brugada syndrome.

AIMS: Risk stratification of sudden cardiac arrest (SCA) in Brugada syndrome (Brs) remains the main challenge for physicians. Several scores have been suggested to improve risk stratification but never replicated. We aim to investigate the accuracy of the Brs risk scores. METHODS AND RESULTS: A total of 1613 patients [mean age 45 ± 15 years, 69% male, 323 (20%) symptomatic] were prospectively enrolled from 1993 to 2016 in a multicentric database. All data described in the risk score were double reviewed for the study. Among them, all patients were evaluated with Shanghai score and 461 (29%) with Sieira score. After a mean follow-up of 6.5 ± 4.7 years, an arrhythmic event occurred in 75 (5%) patients including 16 SCA, 11 symptomatic ventricular arrhythmia, and 48 appropriate therapies. Predictive capacity of the Shanghai score (n = 1613) and the Sieira (n = 461) score was, respectively, estimated by an area under the curve of 0.73 (0.67-0.79) and 0.71 (0.61-0.81). Considering Sieira score, the event rate at 10 years was significantly higher with a score of 5 (26.4%) than with a score of 0 (0.9%) or 1 (1.1%) (P < 0.01). No statistical difference was found in intermediate-risk patients (score 2-4). The Shanghai score does not allow to better stratify the risk of SCA. CONCLUSIONS: In the largest cohort of Brs patient ever described, risk scores do not allow stratifying the risk of arrhythmic event in intermediate-risk patient.

Long-Term Follow-Up of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator: The DAI-T4F Nationwide Registry.

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: A Nationwide French Registry including all patients with tetralogy of Fallot with an ICD was initiated in 2010 by the French Institute of Health and Medical Research. The primary time to event end point 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 (interquartile range) follow-up of 6.8 (2.5-11.4) years, 78 (47.3%) patients received at least 1 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 1 ICD complication, including inappropriate shocks in 42 (25.5%) patients and lead dysfunction in 36 (21.8%) patients. Among 61 (37.0%) patients in primary prevention, the annual rate of appropriate ICD therapies was 4.1%, 5.3%, 9.5%, and 13.3% in patients with, respectively, 0, 1, 2, or ≥3 guidelines-recommended risk factors. QRS fragmentation was the only independent predictor of appropriate ICD therapies (hazard ratio, 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 or reduced left ventricular ejection fraction had a higher risk of nonarrhythmic death or heart transplantation (hazard ratio, 11.01 [95% CI, 2.96-40.95]). CONCLUSIONS: Patients with tetralogy of Fallot 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. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03837574.

Enhancing rare variant interpretation in inherited arrhythmias through quantitative analysis of consortium disease cohorts and population controls.

PURPOSE: Stringent variant interpretation guidelines can lead to high rates of variants of uncertain significance (VUS) for genetically heterogeneous disease like long QT syndrome (LQTS) and Brugada syndrome (BrS). Quantitative and disease-specific customization of American College of Medical Genetics and Genomics/Association for Molecular Pathology (ACMG/AMP) guidelines can address this false negative rate. METHODS: We compared rare variant frequencies from 1847 LQTS (KCNQ1/KCNH2/SCN5A) and 3335 BrS (SCN5A) cases from the International LQTS/BrS Genetics Consortia to population-specific gnomAD data and developed disease-specific criteria for ACMG/AMP evidence classes-rarity (PM2/BS1 rules) and case enrichment of individual (PS4) and domain-specific (PM1) variants. RESULTS: Rare SCN5A variant prevalence differed between European (20.8%) and Japanese (8.9%) BrS patients (p = 5.7 × 10-18) and diagnosis with spontaneous (28.7%) versus induced (15.8%) Brugada type 1 electrocardiogram (ECG) (p = 1.3 × 10-13). Ion channel transmembrane regions and specific N-terminus (KCNH2) and C-terminus (KCNQ1/KCNH2) domains were characterized by high enrichment of case variants and >95% probability of pathogenicity. Applying the customized rules, 17.4% of European BrS and 74.8% of European LQTS cases had (likely) pathogenic variants, compared with estimated diagnostic yields (case excess over gnomAD) of 19.2%/82.1%, reducing VUS prevalence to close to background rare variant frequency. CONCLUSION: Large case-control data sets enable quantitative implementation of ACMG/AMP guidelines and increased sensitivity for inherited arrhythmia genetic testing.

Evolution of high-grade atrioventricular conduction disorders after transcatheter aortic valve implantation in patients who underwent implantation of a pacemaker with specific mode-that minimizes ventricular pacing-activated.

INTRODUCTION: The evolution of atrioventricular conduction disorders after transcatheter aortic valve implantation (TAVI) remains poorly understood. We sought to identify factors associated with late (occurring ≥7 days after the procedure) high-grade atrioventricular blocks after TAVI, based on specific pacemaker memory data. METHODS AND RESULTS: STIM-TAVI (NCT03338582) was a prospective, multicentre, observational study that enrolled all patients (from November 2015 to January 2017) implanted with a specific dual chamber pacemaker after TAVI, with the SafeR algorithm activated, allowing continuous monitoring of atrioventricular conduction. The primary endpoint was the occurrence of centrally adjudicated late high-grade atrioventricular blocks during the year after TAVI. Among 197 patients, 138 (70.1%) had ≥1 late high-grade atrioventricular block. Whereas oversizing (p = .005), high-grade atrioventricular block during TAVI (p < .001), and early (within 6 days) high-grade atrioventricular block (p < .001) were associated with occurrence of late high-grade atrioventricular block, self-expanding prothesis (p = .88), prior right bundle branch block (p = .45), low implantation (p = .06), and new or wider left bundle branch block and lengthening of PR interval (p = .24) were not. In multivariable analysis, only post-TAVI early high-grade atrioventricular block remained associated with late high-grade atrioventricular blocks (Days 0-1: odds ratio [OR], 3.25; 95% confidence interval [CI], 1.57-6.74; p = .001; Days 2-6: OR, 4.13; 95% CI, 2.06-8.31; p < .001), whereas other conventionally used predictors were not. CONCLUSION: One-third of pacemaker-implanted patients do not experience late high-grade atrioventricular block. Our findings suggest that post-TAVI early high-grade atrioventricular block is the main factor associated with occurrence of late high-grade atrioventricular blocks.

Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study.

AIMS: We aimed to provide contemporary real-world data on wearable cardioverter-defibrillator (WCD) use, not only in terms of effectiveness and safety but also compliance and acceptability. METHODS AND RESULTS: Across 88 French centres, the WEARIT-France study enrolled retrospectively patients who used the WCD between May 2014 and December 2016, and prospectively all patients equipped for WCD therapy between January 2017 and March 2018. All patients received systematic education session through a standardized programme across France at the time of initiation of WCD therapy and were systematically enrolled in the LifeVest Network remote services. Overall, 1157 patients were included (mean age 60 ± 12 years, 16% women; 46% prospectively): 82.1% with ischaemic cardiomyopathy, 10.3% after implantable cardioverter-defibrillator explant, and 7.6% before heart transplantation. Median WCD usage period was 62 (37-97) days. Median daily wear time of WCD was 23.4 (22.2-23.8) h. In multivariate analysis, younger age was associated with lower compliance [adjusted odds ratio (OR) 0.97, 95% confidence interval (CI) 0.95-0.99, P < 0.01]. A total of 18 participants (1.6%) received at least one appropriate shock, giving an incidence of appropriate therapy of 7.2 per 100 patient-years. Patient-response button allowed the shock to be aborted in 35.7% of well-tolerated sustained ventricular arrhythmias and in 95.4% of inappropriate ventricular arrhythmia detection, finally resulting in an inappropriate therapy in eight patients (0.7%). CONCLUSION: Our real-life findings reinforce previous studies on the efficacy and safety of the WCD in the setting of transient high-risk group in selected patients. Moreover, they emphasize the fact that when prescribed appropriately, in concert with adequate patient education and dedicated follow-up using specific remote monitoring system, compliance with WCD is high and the device well-tolerated by the patient.

Multimodality imaging approach for the diagnosis of a left atrial mass.

BACKGROUND: Cardiac masses may be incidentally found or in relation to the clinical presentation. Depending on the complexity of the lesion, a multimodality imaging approach may be necessary for a proper diagnosis. CASE REPORT: We report the case of a 64-year-old male patient who was referred for pre-chemotherapy work-up of a metastatic scrotal melanoma. Echocardiography showed incidental heterogeneous left atrial mass. Further investigation using cardiovascular magnetic resonance imaging, computed tomography angiography, and positron emission tomography confirmed the findings that were consistent with a left atrial myxoma vascularized by a left circumflex coronary-cameral fistula. CONCLUSIONS: When the clinical context may be misleading, assessment of a cardiac mass with a multimodality approach is essential in order to define its exact benign or malignant nature.

Peri-procedural management, implantation feasibility, and short-term outcomes in patients undergoing implantation of leadless pacemakers: European Snapshot Survey.

The aim of this European Heart Rhythm Association (EHRA) prospective snapshot survey is to assess procedural settings, safety measures, and short-term outcomes associated with implantation of leadless pacemakers (LLPM), across a broad range of tertiary European electrophysiology centres. An internet-based electronic questionnaire (30 questions) concerning implantation settings, peri-procedural routines, complications, and in-hospital patient outcomes was circulated to centres routinely implanting both LLPMs and transvenous pacemakers (TV-PM). The centres were requested to prospectively include consecutive patients implanted with either LLPMs or TV-PMs during the 10-week enrolment period. Overall, 21 centres from four countries enrolled 825 consecutive patients between November 2018 and January 2019, including 69 (9%) implanted with LLPMs. Leadless pacemakers were implanted mainly under local anaesthesia (69%), by an electrophysiologist (60%), in the electrophysiology laboratory (71%); 95% of patients received prophylactic antibiotics prior to implantation. Most patients on chronic oral anticoagulation were operated on-drug (35%), or during short-term (to 48 h) drug withdrawal (54%). Implantation was successful in 98% of patients and the only in-hospital procedure-related complication was groyne haematoma in one patient. This EHRA snapshot survey provides important insights into LLPM implantation routines and patient outcomes. These findings suggest that despite the unfavourable clinical profile of pacemaker recipients, LLPM implantation is associated with relatively low risk of complications and good short-term outcomes.

Late discovery of left atrial appendage occluder device embolization: a case report.

BACKGROUND: Left atrial appendage (LAA) closure has been well evaluated in the prevention of stroke in patients with atrial fibrillation. Device embolization remains one of the most common complications. To the best of our knowledge, there have been no reports of late discovery of LAA occluder device embolization at 1.5 years after implantation. CASE PRESENTATION: We describe the case of a 77-year-old man who underwent uneventful LAA closure. Echocardiography performed the next day showed the device in place. The patient was discharged but was then lost to follow-up. 1.5 years later, he was admitted for ischemic stroke. Transesophageal echocardiography showed the absence of the occluder device in the LAA. Computed tomography scan of the abdomen showed the device in the abdominal aorta. Due to the high cardiovascular risk, the device was kept in place and the patient was treated medically. CONCLUSIONS: Per-procedural and late device embolization are not uncommon. Review of the literature however showed no report of late discovery of device embolization at 1.5 years. Follow-up echocardiography is mandatory for the detection of endothelialization or embolization.

Leadless pacemaker implant in patients with pre-existing infections: Results from the Micra postapproval registry.

INTRODUCTION: Leadless pacemakers may provide a safe and attractive pacing option to patients with cardiac implantable electronic device (CIED) infection. We describe the characteristics and outcomes of patients with a recent CIED infection undergoing Micra implant attempt. METHODS AND RESULTS: Patients with prior CIED infection and device explant with Micra implant within 30 days, were identified from the Micra post approval registry. Procedure characteristics and outcomes were summarized. A total of 105 patients with prior CIED infection underwent Micra implant attempt ≤30 days from prior system explant (84 [80%] pacemakers and 13 [12%] ICD/CRT-D). All system components were explanted in 93% of patients and explant occurred a median of 6 days before Micra implant, with 37% occurring on the day of Micra implant. Micra was successfully implanted in 99% patients, mean follow-up duration was 8.5 ± 7.1 months (range 0-28.5). The majority of patients (91%) received IV antibiotics preimplant, while 42% of patients received IV antibiotics postprocedure. The median length of hospitalization following Micra implant was 2 days (IQR, 1-7). During follow-up, two patients died from sepsis and four patients required system upgrade, of which two patients received Micra to provide temporary pacing support. There were no Micra devices explanted due to infection. CONCLUSION: Implantation of the Micra transcatheter pacemaker is safe and feasible in patients with a recent CIED infection. No recurrent infections that required Micra device removal were seen. Leadless pacemakers appear to be a safe pacing alternative for patients with CIED infection who undergo extraction.

In vivo validation of Dosemap software use in interventional cardiology with dosimetrics indicators and peak skin dose evaluation.

OBJECTIVES: The aim of this study was to determine the accuracy of DoseMap™ software as compared to gafchromic film in real clinical practices. BACKGROUND: The radiation exposure from cardiovascular procedures could expose patients to potential risk of cancer and/or skin injury. New tools like Dosemap software were developed to estimate the patient skin dose in the cardiac catheterization laboratory. However, little data are available to validate this estimation of patient radiation skin dose. METHODS: This is a prospective cross-sectional study comparing the peak skin dose (PSD) measured by gafchromic film used as reference with an estimated PSD given by Dosemap software, in patients with BMI > 30 kg/m2 undergoing elective diagnostic and/or therapeutic interventional cardiology procedures, from April 2016 to December 2016, at the Brest University Hospital Centre, France. RESULTS: After four exclusions of patients for poor quality of gafchromic films, 90 patients were included, with 58 angiography (67.4%), 14 percutaneous interventions (16.3%), and 14 both (16.3%). The median PSDDosemap and PSDFilm were similar with 157 mGy [IQR: 99; 273] versus 158 mGy [IQR: 101; 295] (P = 0.65), respectively, with an excellent correlation (r = 0.95). The comparison between cumulative air kerma and PSDFilm was different 366 mGy [IQR: 246; 575] versus 158 mGy [IQR: 101; 295] (P < 0.01) with moderate correlation (r = 0.79). No correlation was found between the dose area product and PSDFilm (r = 0.51). CONCLUSION: DoseMap is an effective and valid method as compared to gafchromic films to estimate PSDs during interventional cardiologic procedures.

Antithrombotic treatment in patients with atrial fibrillation and acute coronary syndromes: results of the European Heart Rhythm Association survey.

The management of an acute coronary syndrome (ACS) in a patient with existing atrial fibrillation (AF) often presents a management dilemma both in the acute phase and post-ACS, since the majority of AF patients will already be receiving oral anticoagulation (OAC) for stroke prevention and will require further antithrombotic treatment to reduce the risk of in-stent thrombosis or recurrent cardiac events. Current practice recommendations are based largely on consensus option as there is limited evidence from randomized controlled trials. Prior to the launch of the new European Heart Rhythm Association (EHRA) consensus document, a survey was undertaken to examine current clinical management of these patients across centres in Europe. Forty-seven centres submitted valid responses, with the majority (70.2%) being university hospitals. This EHRA survey demonstrated overall the management of ACS in AF patients is consistent with the available guidance. Most centres would use triple therapy for a short duration (4 weeks) and predominantly utilize a strategy of OAC (vitamin K antagonist, VKA or non-vitamin K antagonist oral anticoagulant, NOAC) plus aspirin and clopidogrel, followed by dual therapy [(N)OAC plus clopidogrel] until 12 months post-percutaneous coronary intervention, followed by (N)OAC monotherapy indefinitely. Where NOAC was used in combination with antiplatelet(s), the lower dose of the respective NOAC was preferred, in accordance with current recommendations.

Role of medical reaction in management of inappropriate ventricular arrhythmia diagnosis: the inappropriate Therapy and HOme monitoRiNg (THORN) registry.

AIMS: Implantable cardioverter-defibrillators (ICDs) reduce sudden cardiac death in selected patients but inappropriate ICD shocks have been associated with increased mortality. The THORN registry aims to describe the rate of inappropriate ventricular arrhythmia diagnoses and therapies in patients followed by remote monitoring, as well as the following delay to next patient contact (DNPC). METHODS AND RESULTS: One thousand eight hundred and eighty-two patients issued from a large remote monitoring database first implanted with an ICD for primary or secondary prevention in 110 French hospitals from 2007 to 2014 constitute the THORN population. Among them, 504 patients were additionally followed prospectively for evaluation of the DNPC. Eight hundred and ninety-five out of 1551 (58%) patients had ischaemic heart disease and 358/771 (46%) were implanted for secondary prevention. During 13.7 ± 3.4 months of follow-up, the prevalence of first inappropriate diagnosis in a ventricular arrhythmia zone with enabled therapy was 162/1882 (9%). Among those patients, 122/162 (75%) suffered at least one inappropriate therapy and 58/162 (36%) at least one inappropriate shock. Eighty-three out of 162 (51%) of first inappropriate diagnosis occurred during the first 4 months following implantation. The median DNPC was 8 days (interquartile range 1-26). At least one other day with recording of an inappropriate diagnosis of the same cause occurred in 13/43 (30%) of available DNPC periods, with an inappropriate therapy in 7/13 (54%). CONCLUSION: Inappropriate diagnoses occurred in 9% of patients implanted with an ICD during the first 14 months. The DNPC after inadequate ventricular arrhythmia diagnoses remains long in daily practice and should be optimized. CLINICALTRIALS.GOV IDENTIFIER: NCT01594112.

Comparison of outcomes in infected cardiovascular implantable electronic devices between complete, partial, and failed lead removal: an ESC-EHRA-EORP ELECTRa (European Lead Extraction ConTrolled) registry.

AIMS: The present study sought to determine predictors for success and outcomes of patients who underwent cardiac implantable electronic devices (CIED) extraction indicated for systemic or local CIED related infection in particular where complete lead removal could not be achieved. METHODS AND RESULTS: ESC-EORP ELECTRa (European Lead Extraction ConTRolled Registry) is a European prospective lead extraction registry. Out of the total cohort, 1865/3510 (52.5%) patients underwent removal due to CIED related infection. Predictors and outcomes of failure were analysed. Complete removal was achieved in 1743 (93.5%) patients, partial (<4 cm of lead left) in 88 (4.7%), and failed (>4 cm of lead left) in 32 (1.8%) patients. Removal success was unrelated to type of CIED infection (pocket or systemic). Predictors for failure were older leads and older patients [odds ratio (OR) 1.14 (1.08-1.19), P < 0.0001 and OR 2.68 (1.22-5.91), P = 0.0146, respectively]. In analysis by lead, predictors for failure were: pacemaker vs. defibrillator removal and failure to engage the locking stylet all the way to the tip [OR 0.20 (0.04-0.95), P = 0.03 and OR 0.32 (0.13-0.74), P = 0.008, respectively]. Significantly higher complication rates were noted in the failure group (40.6% vs. 15.9 for partial and 8.7% for success groups, P < 0.0001). Failure to remove a lead was a strong predictor for in hospital mortality [hazard ratio of 2.05 (1.01-4.16), P = 0.046]. CONCLUSION: A total of 6.5% of infected CIED patients failed attempted extraction. Only were >4 cm of lead remained resulted in higher procedural complications and mortality rates.

Cardiac arrhythmias in the emergency settings of acute coronary syndrome and revascularization: an European Heart Rhythm Association (EHRA) consensus document, endorsed by the European Association of Percutaneous Cardiovascular Interventions (EAPCI), and European Acute Cardiovascular Care Association (ACCA).

Despite major therapeutic advances over the last decades, complex supraventricular and ventricular arrhythmias (VAs), particularly in the emergency setting or during revascularization for acute myocardial infarction (AMI), remain an important clinical problem. Although the incidence of VAs has declined in the hospital phase of acute coronary syndromes (ACS), mainly due to prompt revascularization and optimal medical therapy, still up to 6% patients with ACS develop ventricular tachycardia and/or ventricular fibrillation within the first hours of ACS symptoms. Despite sustained VAs being perceived predictors of worse in-hospital outcomes, specific associations between the type of VAs, arrhythmia timing, applied treatment strategies and long-term prognosis in AMI are vague. Atrial fibrillation (AF) is the most common supraventricular tachyarrhythmia that may be asymptomatic and/or may be associated with rapid haemodynamic deterioration requiring immediate treatment. It is estimated that over 20% AMI patients may have a history of AF, whereas the new-onset arrhythmia may occur in 5% patients with ST elevation myocardial infarction. Importantly, patients who were treated with primary percutaneous coronary intervention for AMI and developed AF have higher rates of adverse events and mortality compared with subjects free of arrhythmia. The scope of this position document is to cover the clinical implications and pharmacological/non-pharmacological management of arrhythmias in emergency presentations and during revascularization. Current evidence for clinical relevance of specific types of VAs complicating AMI in relation to arrhythmia timing has been discussed.

Long-term atorvastatin treatment decreases heart maximal oxygen consumption and its vulnerability to in vitro oxidative stress in Watanabe heritable hyperlipidemic rabbit.

Statins are currently used in prevention of cardiovascular diseases in high-risk populations, and could be considered in primary prevention. However, few studies are available on the long-term effects of low doses of statins, especially on mitochondrial function and reactive oxygen species (ROS) metabolism at cardiac level. This study aimed to determine potential effects of a long-term atorvastatin treatment, at low-dose concentration, on the myocardium mitochondrial respiration. Thirty-four Watanabe rabbits were treated or not with atorvastatin (2.5 mg·kg-1·day-1) from the age of 3 to 12 months. Every 3 months, proton leak, basal (V0), and maximal (Vmax) mitochondrial respiration on cardiac permeabilized fibers were measured. Additionally, the vulnerability to ROS, cardiac enzymatic antioxidant defenses, and oxidative damage (lipoperoxidation) were analyzed. Proton leak increased over the duration of the experiment (up to 60% from Vmax at 12 months). Moreover, the statin treatment induced a decrease of Vmax and a decrease of ROS susceptibility of cardiac mitochondria. However, the lipoperoxidation and the antioxidant defenses were not dependent on the presence of statin treatment, or on its duration. This is the first study showing a protective effect of long-term statins treatment against the ROS susceptibility in the cardiac muscle.