Proposed diagnostic criteria for arrhythmogenic cardiomyopathy: European Task Force consensus report.

Arrhythmogenic cardiomyopathy (ACM) is a heart muscle disease characterized by prominent "non-ischemic" myocardial scarring predisposing to ventricular electrical instability. Diagnostic criteria for the original phenotype, arrhythmogenic right ventricular cardiomyopathy (ARVC), were first proposed in 1994 and revised in 2010 by an international Task Force (TF). A 2019 International Expert report appraised these previous criteria, finding good accuracy for diagnosis of ARVC but a lack of sensitivity for identification of the expanding phenotypic disease spectrum, which includes left-sided variants, i.e., biventricular (ABVC) and arrhythmogenic left ventricular cardiomyopathy (ALVC). The ARVC phenotype together with these left-sided variants are now more appropriately named ACM. The lack of diagnostic criteria for the left ventricular (LV) phenotype has resulted in clinical under-recognition of ACM patients over the 4 decades since the disease discovery. In 2020, the "Padua criteria" were proposed for both right- and left-sided ACM phenotypes. The presently proposed criteria represent a refinement of the 2020 Padua criteria and have been developed by an expert European TF to improve the diagnosis of ACM with upgraded and internationally recognized criteria. The growing recognition of the diagnostic role of CMR has led to the incorporation of myocardial tissue characterization findings for detection of myocardial scar using the late­gadolinium enhancement (LGE) technique to more fully characterize right, biventricular and left disease variants, whether genetic or acquired (phenocopies), and to exclude other "non-scarring" myocardial disease. The "ring-like' pattern of myocardial LGE/scar is now a recognized diagnostic hallmark of ALVC. Additional diagnostic criteria regarding LV depolarization and repolarization ECG abnormalities and ventricular arrhythmias of LV origin are also provided. These proposed upgrading of diagnostic criteria represents a working framework to improve management of ACM patients.

Dronedarone Versus Sotalol in Antiarrhythmic Drug-Naive Veterans With Atrial Fibrillation.

BACKGROUND: Sotalol and dronedarone are both used for maintenance of sinus rhythm for patients with atrial fibrillation. However, while sotalol requires initial monitoring for QT prolongation and proarrhythmia, dronedarone does not. These treatments can be used in comparable patients, but their safety and effectiveness have not been compared head to head. Therefore, we retrospectively evaluated the effectiveness and safety using data from a large health care system. METHODS: Using Veterans Health Administration data, we identified 11 296 antiarrhythmic drug-naive patients with atrial fibrillation prescribed dronedarone or sotalol in 2012 or later. We excluded patients with prior conduction disease, pacemakers or implantable cardioverter-defibrillators, ventricular arrhythmia, cancer, renal failure, liver disease, or heart failure. We used natural language processing to identify and compare baseline left ventricular ejection fraction between treatment arms. We used 1:1 propensity score matching, based on patient demographics, comorbidities, and medications, and Cox regression to compare strategies. To evaluate residual confounding, we performed falsification analysis with nonplausible outcomes. RESULTS: The matched cohort comprised 6212 patients (3106 dronedarone and 3106 sotalol; mean [±SD] age, 71±10 years; 2.5% female; mean [±SD] CHA2DS2-VASC, 2±1.3). The mean (±SD) left ventricular ejection fraction was 55±11 and 58±10 for dronedarone and sotalol users, correspondingly. Dronedarone, compared with sotalol, did not demonstrate a significant association with risk of cardiovascular hospitalization (hazard ratio, 1.03 [95% CI, 0.88-1.21]) or all-cause mortality (hazard ratio, 0.89 [95% CI, 0.68-1.16]). However, dronedarone was associated with significantly lower risk of ventricular proarrhythmic events (hazard ratio, 0.53 [95% CI, 0.38-0.74]) and symptomatic bradycardia (hazard ratio, 0.56 [95% CI, 0.37-0.87]). The primary findings were stable across sensitivity analyses. Falsification analyses were not significant. CONCLUSIONS: Dronedarone, compared with sotalol, was associated with a lower risk of ventricular proarrhythmic events and conduction disorders while having no difference in risk of incident cardiovascular hospitalization and mortality. These observational data provide the basis for prospective efficacy and safety trials.

Design and rationale of the MODULAR ATP global clinical trial: A novel intercommunicative leadless pacing system and the subcutaneous implantable cardioverter-defibrillator.

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has demonstrated safety and efficacy for the treatment of malignant ventricular arrhythmias. However, a limitation of the S-ICD lies in the inability to either pace-terminate ventricular tachycardia or provide prolonged bradycardia pacing support. Objective: The rationale and design of a prospective, single-arm, multinational trial of an intercommunicative leadless pacing system integrated with the S-ICD will be presented. Methods: A technical description of the modular cardiac rhythm management (mCRM) system (EMPOWER leadless pacemaker and EMBLEM S-ICD) and the implantation procedure is provided. MODULAR ATP (Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing) is a multicenter, international trial enrolling up to 300 patients at risk of sudden cardiac death at up to 60 centers trial design. The safety endpoint of freedom from major complications related to the mCRM system or implantation procedure at 6 months and 2 years are significantly higher than 86% and 81%, respectively, and all-cause survival is significantly >85% at 2 years. Results: Efficacy endpoints are that at 6 months mCRM communication success is significantly higher than 88% and the percentage of subjects with low and stable thresholds is significantly higher than 80%. Substudies to evaluate rate-responsive features and performance of the pacing module are also described. Conclusion: The MODULAR ATP global clinical trial will prospectively test the safety and efficacy of the first intercommunicating leadless pacing system with the S-ICD. This trial will allow for robust validation of device-device communication, pacing performance, rate responsiveness, and system safety.

Epicardial conduction abnormalities in patients with Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) and mutation positive healthy family members - A study using electrocardiographic imaging.

BACKGROUND: The diagnosis of arrhythmogenic right ventricular cardiomyopathy (ARVC) in early stages is challenging. The aim of this study was therefore to investigate whether electrocardiographic imaging (ECGI) can detect epicardial conduction changes in ARVC patients and healthy mutation-carriers (M-carriers). METHOD: Twelve ARVC patients, 20 M-carriers and 8 controls underwent 12-lead ECG, signal-averaged ECG, 2-dimensional echocardiography, 24-hours Holter monitoring and ECGI (body surface mapping and computer tomography with offline analysis of reconstructed epicardial signals). Total and Right Ventricular Activation Time (tVAT and RVAT respectively), area of Ventricular Activation during the terminal 20 milliseconds (aVAte20) and the activation patterns were compared between groups. RESULTS: In ARVC patients the locations of aVAte20 were scattered or limited to smaller parts of the right ventricle (RV) versus in controls, in whom aVAte20 was confined to right ventricular outflow tract (RVOT) and left ventricle (LV) base (+/- RV base). ARVC patients had smaller aVAte20 (35cm2 vs 87cm2, p<0.05), longer tVAT (99msec vs 58msec, p<0.05) and longer RVAT (66msec vs 43msec, p<0.05) versus controls. In 10 M-carriers (50%), the locations of aVAte20 were also eccentric. This sub-group presented smaller aVAte20 (53cm2 vs 87cm2, p = 0.009), longer RVAT (55msec vs 48msec, p = 0.043), but similar tVAT (65msec vs 60msec, p = 0.529) compared with the M-carriers with normal activation pattern. CONCLUSIONS: ECGI can detect epicardial conduction abnormalities in ARVC patients. Moreover, the observation of localized delayed RV epicardial conduction in M-carriers suggests an early stage of ARVC and may be a useful diagnostic marker enhancing an early detection of the disease.

Impact of ABC (Atrial Fibrillation Better Care) pathway adherence in high-risk subgroups with atrial fibrillation: A report from the ESC-EHRA EORP-AF long-term general registry.

BACKGROUND: Effects of Atrial Fibrillation Better Care (ABC) adherence among high-risk atrial fibrillation (AF) subgroups remains unknown. We aimed to evaluate the impact of ABC adherence on clinical outcomes in these high-risk patients. METHODS: EORP-AF General Long-Term Registry is a prospective, observational registry from 250 centres across 27 European countries. High-risk patients were defined as those with either CKD (eGFR <60 mL/min/1.73m2), elderly patients (≥75 years) or prior thromboembolism. Primary outcome was a composite event of all-cause death, thromboembolism and acute coronary syndrome. RESULTS: 6646 patients with AF were screened (median age was 70 [IQR 61 - 77] years; 40.2% females). There were 3304 (54.2%) patients with either CKD (n = 1750), older age (n = 2236) or prior thromboembolism (n = 728). Among these, 924 (28.0%) were managed as adherent to ABC. At 2-year follow-up, 966 (14.5%) patients reported the primary outcome. The incidence of the primary outcome was significantly lower in high-risk patients managed as adherent to ABC pathway (IRR 0.53 [95%CI, 0.43 - 0.64]). Consistent results were obtained in the individual subgroups. Using multivariable Cox proportional hazards analysis, ABC adherence in the high-risk cohort was independently associated with a lower risk of the primary outcome (aHR 0.64 [95%CI, 0.51 - 0.80]), as well as in the CKD (aHR 0.51 [95%CI, 0.37 - 0.70]) and elderly subgroups (aHR 0.69 [95%CI, 0.53 - 0.90]). Overall, there was greater reduction in the risk of primary outcome as more ABC criteria were fulfilled, both in the overall high-risk patients (aHR 0.39 [95%CI, 0.25 - 0.61]), as well as in the individual subgroups. CONCLUSION: In a large, contemporary cohort of patients with AF, we demonstrate that adherence to the ABC pathway was associated with a significant benefit among high-risk patients with either CKD, advanced age (≥75 years old) or prior thromboembolism.

A short P-wave duration is associated with incident heart failure in the elderly: a 15 years follow-up cohort study.

BACKGROUND: Early identification of patients at risk of congestive heart failure (HF) may alter their poor prognosis. The aim was therefore to test whether simple electrocardiographic variables, the P-wave and PR-interval, could predict incident HF. METHODS: The PIVUS (Prospective Investigation of the Vasculature in Uppsala Seniors) study (1016 individuals all aged 70 years, 50% women) was used to identify predictors of HF. Subjects with prevalent HF, QRS duration ≥ 130 ms, atrial tachyarrhythmias, implanted pacemaker/defibrillator, second- and third-degree atrioventricular block or delta waves at baseline were excluded. Cox proportional hazard analysis was used to relate the PR interval, P-wave duration (Pdur) and amplitude (Pamp), measured in lead V1, to incident HF. Adjustment was performed for gender, RR-interval, beta-blocking agents, systolic blood pressure, body mass index and smoking. RESULTS: Out of 836 subjects at risk, 107 subjects were diagnosed with HF during a follow-up of 15 years. In the multivariate analysis, there was a strong U-shaped correlation between Pdur in lead V1 and incident HF (P = 0.0001) which was significant for a Pdur < 60 ms [HR = 2.75; 95% CI: 1.87-4.06, at Pdur 40 ms] but not for prolonged Pdur. There was no significant relationship between incident HF and the PR-interval or the Pamp. A Pdur < 60 ms improved discrimination by 3.7% when added to the traditional risk factors including sex, RR-interval, beta-blocking agents, systolic blood pressure, BMI and smoking (P = 0.048). CONCLUSIONS: A short Pdur, an easily measured parameter on the ECG, may potentially be a useful marker of future HF, enabling its early detection and prevention, thus improving outcomes.

Short P-Wave Duration Is Associated with Incident Atrial Fibrillation.

Atrial fibrillation (AF) is common and increases the risk for stroke and heart failure (HF). The early identification of patients at risk may prevent the development of AF and improve prognosis. This study, therefore, aimed to test the effect of the association between P-wave and PR-interval on the ECG and incident AF.The PIVUS (Prospective Investigation of the Vasculature in Uppsala Seniors) study (1016 individuals all aged 70 years; 50% women) was used to identify whether the ECG variables P-wave duration (Pdur) and PR-duration in lead V1 were related to new-onset AF. Exclusion criteria were prevalent AF, QRS-duration ≥ 130 milliseconds (msec), atrial tachyarrhythmias and implanted pacemaker/defibrillator. Cox proportional-hazards models were used for analyses. Adjustments were made for gender, RR-interval, beta-blocking agents, systolic blood pressure, body mass index, and smoking.Of 877 subjects at risk, 189 individuals developed AF during a 15-year follow-up. There was a U-shaped relationship between the Pdur and incident AF (P = 0.017) following multiple adjustment. Values below 60 msec were significantly associated with incident AF, with a hazard ratio of 1.55 (95% confidence interval 1.15-2.09) for a Pdur ≤ 42 msec. There was no significant relationship between incident AF and the PR-interval.A short Pdur derived from the ECG in V1 may be a useful marker for new-onset AF, enabling the early identification of at-risk patients.

Repolarization abnormalities unmasked with a 252-lead BSM system in patients with ARVC and healthy gene carriers.

BACKGROUND: Diagnosing arrhythmogenic right ventricular cardiomyopathy (ARVC) at an early stage can be challenging even after ECG recording and a combination of several imaging techniques. The purpose of this study was to explore if a body surface mapping (BSM) system with 252-leads could identify repolarization abnormalities and thereby diagnose early stages of ARVC. METHODS: ARVC patients, gene carriers without signs of ARVC and controls underwent a 12-lead resting ECG, signal-averaged ECG, echocardiography, 24-hours Holter monitoring, and BSM with electrocardiographic imaging (ECGI). All 252-leads, divided into four quadrants of the vest, were analyzed regarding concordances between T wave polarity and QRS main vector. RESULTS: Of 40 patients included there were 12 ARVC patients, 20 gene carriers, and 8 controls. The ARVC patients had two different repolarization patterns, one with more pronounced negative T waves at the lower left panel and another with mixed changes that clearly differed from the controls, all of whom had a normal 12 lead ECGs and consistent repolarization patterns on their BSM recordings. The patterns observed in ARVC patients were also present in 5/20 (25%) gene carriers, three of whom had normal resting ECG. A novel repolarization index successfully detected all ARVC patients and 88% of gene carriers with pathologic repolarization pattern. CONCLUSIONS: The finding that abnormal repolarization patterns could be unmasked by BSM in 25% of healthy gene carriers, suggests that it may potentially be a useful tool for identifying early manifestations of ARVC. Further and larger studies are warranted to assess its diagnostic accuracy.

Impact of renal impairment on atrial fibrillation: ESC-EHRA EORP-AF Long-Term General Registry.

BACKGROUND: Atrial fibrillation (AF) and renal impairment share a bidirectional relationship with important pathophysiological interactions. We evaluated the impact of renal impairment in a contemporary cohort of patients with AF. METHODS: We utilised the ESC-EHRA EORP-AF Long-Term General Registry. Outcomes were analysed according to renal function by CKD-EPI equation. The primary endpoint was a composite of thromboembolism, major bleeding, acute coronary syndrome and all-cause death. Secondary endpoints were each of these separately including ischaemic stroke, haemorrhagic event, intracranial haemorrhage, cardiovascular death and hospital admission. RESULTS: A total of 9306 patients were included. The distribution of patients with no, mild, moderate and severe renal impairment at baseline were 16.9%, 49.3%, 30% and 3.8%, respectively. AF patients with impaired renal function were older, more likely to be females, had worse cardiac imaging parameters and multiple comorbidities. Among patients with an indication for anticoagulation, prescription of these agents was reduced in those with severe renal impairment, p < .001. Over 24 months, impaired renal function was associated with significantly greater incidence of the primary composite outcome and all secondary outcomes. Multivariable Cox regression analysis demonstrated an inverse relationship between eGFR and the primary outcome (HR 1.07 [95% CI, 1.01-1.14] per 10 ml/min/1.73 m2 decrease), that was most notable in patients with eGFR <30 ml/min/1.73 m2 (HR 2.21 [95% CI, 1.23-3.99] compared to eGFR ≥90 ml/min/1.73 m2 ). CONCLUSION: A significant proportion of patients with AF suffer from concomitant renal impairment which impacts their overall management. Furthermore, renal impairment is an independent predictor of major adverse events including thromboembolism, major bleeding, acute coronary syndrome and all-cause death in patients with AF.

QRS dispersion detected in ARVC patients and healthy gene carriers using 252-leads body surface mapping: an explorative study of a potential diagnostic tool for arrhythmogenic right ventricular cardiomyopathy.

BACKGROUND: The diagnosis of ARVC remains complex requiring both imaging and electrocardiographic (ECG) techniques. The purpose was therefore to investigate whether QRS dispersion assessed by body surface mapping (BSM) could be used to detect early signs of ARVC, particularly in gene carriers. METHODS: ARVC patients, gene carriers without a history of arrhythmias or structural cardiac changes and healthy controls underwent 12-lead resting ECG, signal-averaged ECG, echocardiographic examination, 24-hours Holter monitoring, and BSM with electrocardiographic imaging. All 252-leads BSM recordings and 12-leads ECG recordings were manually analyzed for QRS durations and QRS dispersion. RESULTS: Eight controls, 12 ARVC patients with definite ARVC and 20 healthy gene carriers were included. The ECG-QRS dispersion was significantly greater in ARVC patients (42 vs. 25 ms, p < .05), but failed to fully differentiate them from controls. The BSM-derived QRS dispersion was also significantly greater in ARVC patients versus controls (65 vs. 29 ms, p < .05) and distinguished 11/12 cases from controls using the cut-off 40msec. The BSM derived QRS dispersion was abnormal (> 40 ms) in 4/20 healthy gene carriers without signs of ARVC, which may indicate early depolarization changes. CONCLUSIONS: QRS dispersion, when assessed by BSM versus 12-lead ECG, seem to better distinguish ARVC patients from controls, and could potentially be used to detect early ARVC in gene carriers. Further studies are required to confirm the value of BSM-QRS dispersion in this respect.

Adenosine usage during AF ablation in Europe and selected long-term findings from the ESC-EHRA EORP Atrial Fibrillation Ablation Long-Term registry.

BACKGROUND: Adenosine can be used to reveal dormant pulmonary vein (PV) conduction after PV isolation (PVI). This study presents a subanalysis of real-world 1-year follow-up data from the ESC-EHRA EORP Atrial Fibrillation (AF) Ablation Long-Term registry to analyze the usage of adenosine during PVI treatment in terms of rhythm outcome and safety. METHODS: The registry consists of 104 participating centers in 27 countries within the European Society of Cardiology. The registry data was split into an adenosine group (AG) and no-adenosine group (NAG). Procedure characteristics and patient outcome were compared. RESULTS: Adenosine was administered in 10.8% of the 3591 PVI patients included in the registry. Spain, the Netherlands, and Italy included the majority of adenosine cases (48.8%). Adenosine was applied more often in combination with open irrigation radiofrequency (RF) energy (74.7%) and less often in combination with nonirrigated RF energy (1.6%). After 1 year, a higher percentage of the AG was free from AF compared with the NAG (68.9% vs 59.1%, p < 0.001). Adenosine was associated with better rhythm outcome in RF ablation procedures, but not in cryo-ablation procedures (freedom from AF: RF: AG: 70.9%, NAG: 58.1%, p < 0.001, cryo: AG: 63.9%, NAG: 63.8%, p = 0.991). CONCLUSIONS: The use of adenosine was associated with a better rhythm outcome after 1 year follow-up and seems more useful in patients treated with RF energy compared with patients treated with cryo energy. Given the improved rhythm outcome at 1-year follow-up, it seems reasonable to encourage the use of adenosine during RF AF ablation.

Atrial fibrillation ablation long-term ESC-EHRA EORP AFA LT registry: in-hospital and 1-year follow-up findings in Italy.

AIM: To report the Italian data deriving from the European Society of Cardiology-EURObservational Research Program atrial fibrillation ablation long-term registry. METHODS AND RESULTS: Ten Italian centers enrolled up to 50 consecutive patients undergoing atrial fibrillation ablation. Of the 318 patients included, 5 (1.6%) did not undergo catheter ablation, 1 had ablation partially done and 62 were lost at 1-year follow-up. Women were less represented (23.6%) and the median age was 60.0 years. A total of 195 patients (62.3%) suffered paroxysmal atrial fibrillation, whereas only 9 (2.9%) had long-standing persistent atrial fibrillation. Most Italian patients (92.3%) were symptomatic but suffering fewer symptomatic events than patients enrolled in other countries (median of two events in the month preceding the ablation vs. three, respectively; P < 0.0001). The main finding of the study is that the success rate at 1 year, with and without antiarrhythmic drugs, was 76.4%, consistently with other participating countries (73.4%). This result was obtained however, with a significantly lower prevalence of 1-year adverse events (7.3 vs. 16.6%, P < 0.0001). Procedure duration and fluoroscopy total time resulted as being shorter in Italy (145 vs. 160, P = 0.0005 and 16.9 vs. 20.0 min, P = 0.0018, respectively); however, the radiation dose per BSA was greater (37.5 vs. 26.0 mGy/cm, P = 0.0022). CONCLUSION: The demographic characteristics of patients undergoing atrial fibrillation ablation are similar to those reported in other countries. The success rate in Italy is consistent with those in other countries, whereas the complications rate is lower.

European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections-endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), International Society for Cardiovascular Infectious Diseases (ISCVID), and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS).

Pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices are potentially lifesaving treatments for a number of cardiac conditions but are not without risk. Most concerning is the risk of a cardiac implantable electronic device (CIED) infection, which is associated with significant morbidity, increased hospitalizations, reduced survival, and increased health care costs. Recommended preventive strategies such as administration of intravenous antibiotics before implantation are well-recognized. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, antibacterial envelopes, prolonged antibiotics post-implantation, and others. When compared with previous guidelines or consensus statements, the present consensus document gives guidance on the use of novel device alternatives, novel oral anticoagulants, antibacterial envelopes, prolonged antibiotics post-implantation, as well as definitions on minimum quality requirements for centres and operators and volumes. The recognition that an international consensus document focused on management of CIED infections is lacking, the dissemination of results from new important randomized trials focusing on prevention of CIED infections, and observed divergences in managing device-related infections as found in an European Heart Rhythm Association worldwide survey, provided a strong incentive for a Novel 2019 International State-of-the-art Consensus document on risk assessment, prevention, diagnosis, and treatment of CIED infections.

European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections-endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), International Society for Cardiovascular Infectious Diseases (ISCVID) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS).

Pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices are potentially life-saving treatments for a number of cardiac conditions, but are not without risk. Most concerning is the risk of a cardiac implantable electronic device (CIED) infection, which is associated with significant morbidity, increased hospitalizations, reduced survival, and increased healthcare costs. Recommended preventive strategies such as administration of intravenous antibiotics before implantation are well recognized. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, anti-bacterial envelopes, prolonged antibiotics post-implantation, and others. Guidance on whether to use novel device alternatives expected to be less prone to infections and novel oral anticoagulants is also limited, as are definitions on minimum quality requirements for centres and operators and volumes. Moreover, an international consensus document on management of CIED infections is lacking. The recognition of these issues, the dissemination of results from important randomized trials focusing on prevention of CIED infections, and observed divergences in managing device-related infections as found in an European Heart Rhythm Association worldwide survey, provided a strong incentive for a 2019 International State-of-the-art Consensus document on risk assessment, prevention, diagnosis, and treatment of CIED infections.

European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections-endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), International Society for Cardiovascular Infectious Diseases (ISCVID) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS).

Pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices are potentially life-saving treatments for a number of cardiac conditions, but are not without risk. Most concerning is the risk of a cardiac implantable electronic device (CIED) infection, which is associated with significant morbidity, increased hospitalizations, reduced survival, and increased healthcare costs. Recommended preventive strategies such as administration of intravenous antibiotics before implantation are well recognized. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, anti-bacterial envelopes, prolonged antibiotics post-implantation, and others. Guidance on whether to use novel device alternatives expected to be less prone to infections and novel oral anticoagulants is also limited, as are definitions on minimum quality requirements for centres and operators and volumes. Moreover, an international consensus document on management of CIED infections is lacking. The recognition of these issues, the dissemination of results from important randomized trials focusing on prevention of CIED infections, and observed divergences in managing device-related infections as found in an European Heart Rhythm Association worldwide survey, provided a strong incentive for a 2019 International State-of-the-art Consensus document on risk assessment, prevention, diagnosis, and treatment of CIED infections.

Sex-Related Procedural Aspects and Complications in CRT Survey II: A Multicenter European Experience in 11,088 Patients.

OBJECTIVES: This study sought to compare sex difference for procedural aspects and complications in the European Society of Cardiology CRT Survey II, exploring whether adverse events were related to the type of CRT device implanted. BACKGROUND: Sex-related differences in procedural aspects and complications in patients undergoing cardiac resynchronization therapy (CRT) implantation has not been explored in a real-life population. METHODS: A post-hoc analysis of procedural data and complications in different sexes and factors associated with events was performed from data collected in the European Society of Cardiology CRT Survey II. RESULTS: Of all patients (n = 11,088) included, 24.3% were women. The mean age (70 years of age) of male and female recipients was similar. Female patients more frequently had an idiopathic cardiomyopathy (67.4% vs. 44.1%) and fewer comorbidities, including atrial fibrillation (34.8% vs. 42.8%), diabetes (29.1% vs. 32.1%), chronic obstructive lung disease (10.3% vs. 12.6%), and renal failure (28.7% vs. 31.9%), compared with men. More women compared with men had a pacemaker (56.6% vs. 46.3%) and much less often an implantable cardioverter-defibrillator (CRT-D) (19.0% vs. 34.7%) implant. Periprocedural event rate was the highest in women with CRT with defibrillator (7.1% vs. 4.8% in men), followed by women with a CRT with pacing (5.5% vs. 4.4% in men). The higher periprocedural event rate in CRT-D women was attributable primarily to the occurrence of pneumothorax (1.4%), coronary sinus dissection (2.1%), and pericardial tamponade (0.3%). The rate of in-hospital major adverse events (6.0%) and complications necessitating reoperation (4.0%) was not different among sex and device type. CONCLUSIONS: Women are more likely to experience adverse procedure-related events during CRT implantation. Thus, preventive strategies should be employed to minimize complication rate.

Influence of risk factors in the ESC-EHRA EORP atrial fibrillation ablation long-term registry.

BACKGROUND: The influence of risk factors on atrial fibrillation (AF) ablation recurrence is increasingly recognized. We present a sub-analysis of the European Society of Cardiology-European Heart Rhythm Association-European Society of Cardiology AF ablation long-term registry on the effect of traditional risk factors for AF on postablation recurrence, reablation, and complications using real-world data. METHODS: Risk factors for AF were defined as body mass index ≥27 kg/m², hypertension, chronic obstructive pulmonary disease, diabetes, alcohol ≥2 units/day, sleep apnea, smoking, no/occasional sports activity, moderate/severe mitral or aortic valve disease, any cardiomyopathy, peripheral vascular disease, chronic kidney disease, heart failure, coronary artery disease/infarction, and previous pacemaker/defibrillator implant. Patients were divided in two groups with ≥1 or without risk factors. Primary outcomes were arrhythmia recurrence after blanking period, reablation, and adverse events or death. Differences between the groups and the influence of individual risk factors were analyzed using multivariate Cox regression. RESULTS: Three thousand sixty nine patients were included; 217 patients were without risk factors. Risk factor patients were older (58.4 vs 54.1 years), more often female (32% vs 19.8%) and had more often persistent AF (27.2% vs 23.5%). In a multivariate analysis, patients without risk factors had a hazard ratio of 0.70 (95% CI 0.49-0.99) for recurrence compared to risk factor patients. The multivariate hazard ratios for reablation or adverse events/death were not different between the two groups. Hypertension and body mass index were univariate predictors of recurrence. CONCLUSIONS: Patients with ≥1 risk factor had a 30% higher risk for arrhythmia recurrence after ablation, but no differences in risk for repeat ablations and adverse events or death.