Cardioversion in patients with newly diagnosed non-valvular atrial fibrillation: observational study using prospectively collected registry data.

OBJECTIVE: To investigate the clinical outcomes of patients who underwent cardioversion compared with those who did not have cardioverson in a large dataset of patients with recent onset non-valvular atrial fibrillation. DESIGN: Observational study using prospectively collected registry data (Global Anticoagulant Registry in the FIELD-AF-GARFIELD-AF). SETTING: 1317 participating sites in 35 countries. PARTICIPANTS: 52 057 patients aged 18 years and older with newly diagnosed atrial fibrillation (up to six weeks' duration) and at least one investigator determined stroke risk factor. MAIN OUTCOME MEASURES: Comparisons were made between patients who received cardioversion and those who had no cardioversion at baseline, and between patients who received direct current cardioversion and those who had pharmacological cardioversion. Overlap propensity weighting with Cox proportional hazards models was used to evaluate the effect of cardioversion on clinical endpoints (all cause mortality, non-haemorrhagic stroke or systemic embolism, and major bleeding), adjusting for baseline risk and patient selection. RESULTS: 44 201 patients were included in the analysis comparing cardioversion and no cardioversion, and of these, 6595 (14.9%) underwent cardioversion at baseline. The propensity score weighted hazard ratio for all cause mortality in the cardioversion group was 0.74 (95% confidence interval 0.63 to 0.86) from baseline to one year follow-up and 0.77 (0.64 to 0.93) from one year to two year follow-up. Of the 6595 patients who had cardioversion at baseline, 299 had a follow-up cardioversion more than 48 days after enrolment. 7175 patients were assessed in the analysis comparing type of cardioversion: 2427 (33.8%) received pharmacological cardioversion and 4748 (66.2%) had direct current cardioversion. During one year follow-up, event rates (per 100 patient years) for all cause mortality in patients who received direct current and pharmacological cardioversion were 1.36 (1.13 to 1.64) and 1.70 (1.35 to 2.14), respectively. CONCLUSION: In this large dataset of patients with recent onset non-valvular atrial fibrillation, a small proportion were treated with cardioversion. Direct current cardioversion was performed twice as often as pharmacological cardioversion, and there appeared to be no major difference in outcome events for these two cardioversion modalities. For the overall cardioversion group, after adjustments for confounders, a significantly lower risk of mortality was found in patients who received early cardioversion compared with those who did not receive early cardioversion. STUDY REGISTRATION: ClinicalTrials.gov NCT01090362.

Cardioversion Safety - Are We Doing Enough?

There is a considerable periprocedural risk of thromboembolic events in atrial fibrillation patients undergoing cardioversion, and treatment with anticoagulants is therefore a hallmark of cardioversion safety. Based on retrospective subgroup analyses and prospective studies, non-vitamin K anticoagulants are at least as efficient as vitamin K-antagonists in preventing thromboembolic complications after cardioversion. The risk of thromboembolic complications after cardioversion very much depends on the comorbidities in a given patient, and especially heart failure, diabetes, and age >75 years carry a markedly increased risk. Cardioversion has been considered safe within a 48-h time window after onset of atrial fibrillation without prior treatment with anticoagulants, but recent studies have set this practice into question based on e.g. erratic debut assessment of atrial fibrillation. Therefore, a simple and more practical approach is here suggested, where early cardioversion is performed only in hemodynamically unstable patients.

Preliminary experience with the multisensor HeartLogic algorithm for heart failure monitoring: a retrospective case series report.

AIMS: In the Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients study, a novel algorithm for heart failure (HF) monitoring was implemented. The HeartLogic (Boston Scientific) index combines data from multiple implantable cardioverter defibrillator (ICD)-based sensors and has proved to be a sensitive and timely predictor of impending HF decompensation. The remote monitoring of HF patients by means of HeartLogic has never been described in clinical practice. We report post-implantation data collected from sensors, the combined index, and their association with clinical events during follow-up in a group of patients who received a HeartLogic-enabled device in clinical practice. METHODS AND RESULTS: Patients with ICD and cardiac resynchronization therapy ICD were remotely monitored. In December 2017, the HeartLogic feature was activated on the remote monitoring platform, and multiple ICD-based sensor data collected since device implantation were made available: HeartLogic index, heart rate, heart sounds, thoracic impedance, respiration, and activity. Their association with clinical events was retrospectively analysed. Data from 58 patients were analysed. During a mean follow-up of 5 ± 3 months, the HeartLogic index crossed the threshold value (set by default to 16) 24 times (over 24 person-years, 0.99 alerts/patient-year) in 16 patients. HeartLogic alerts preceded five HF hospitalizations and five unplanned in-office visits for HF. Symptoms or signs of HF were also reported at the time of five scheduled visits. The median early warning time and the time spent in alert were longer in the case of hospitalizations than in the case of minor events of clinical deterioration of HF. HeartLogic contributing sensors detected changes in heart sound amplitude (increased third sound and decreased first sound) in all cases of alerts. Patients with HeartLogic alerts during the observation period had higher New York Heart Association class (P = 0.025) and lower ejection fraction (P = 0.016) at the time of activation. CONCLUSIONS: Our retrospective analysis indicates that the HeartLogic algorithm might be useful to detect gradual worsening of HF and to stratify risk of HF decompensation.

Preliminary experience with a novel Multisensor algorithm for heart failure monitoring: The HeartLogic index.

We report the first case of a patient in whom an implantable cardioverter-defibrillator (ICD) endowed with HeartLogic, a novel algorithm for heart failure (HF) monitoring, was implanted in clinical practice. The good temporal association between HeartLogic index threshold crossings and HF hospitalizations confirms the high sensitivity in detecting gradual worsening of HF.

[Electromagnetic interference in the current era of cardiac implantable electronic devices designed for magnetic resonance environment]. / Le interferenze elettromagnetiche nell'era dei dispositivi elettronici cardiaci impiantabili compatibili con la risonanza magnetica.

In the last decades we are observing a continuous increase in the number of patients wearing cardiac implantable electronic devices (CIEDs). At the same time, we face daily with a domestic and public environment featured more and more by the presence and the utilization of new emitters and finally, more medical procedures are based on electromagnetic fields as well. Therefore, the topic of the interaction of devices with electromagnetic interference (EMI) is increasingly a real and actual problem.In the medical environment most attention is paid to magnetic resonance, nevertheless the risk of interaction is present also with ionizing radiation, electrical nerve stimulation and electrosurgery. In the non-medical environment, most studies reported in the literature focused on mobile phones, metal detectors, as well as on headphones or digital players as potential EMI sources, but many other instruments and tools may be intentional or non-intentional sources of electromagnetic fields.CIED manufacturers are more and more focusing on new technological features in order to make implantable devices less susceptible to EMI. However, patients and emitter manufacturers should be aware that limitations exist and that there is not complete immunity to EMI.

Radiation dose among different cardiac and vascular invasive procedures: The RODEO study.

BACKGROUND: Interventional radiology and cardiology procedures contribute significantly to the collective dose of radiation exposure from medical interventions. Recent and dedicated studies comparing directly these procedures in term of patient radiation exposure are lacking. Our aim was to compare radiation exposure among different interventional procedures performed under fluoroscopic guidance. METHODS: The RODEO study (NCT: 02972736) is an international observational retrospective multicenter study enrolling all patients undergoing diagnostic or interventional procedures performed by different interventional operators (i.e. radiologists, interventional cardiologists or electrophysiologists) in 6 centers, without exclusion criteria. The primary end-point of the study was the comparison of dose area product (DAP) among interventional cardiology, electrophysiology or interventional radiology procedures. RESULTS: A total of 17,711 procedures were included in the study: 13,522 interventional cardiology, 2352 electrophysiology and 1864 interventional radiology procedures. The highest DAP values were observed for interventional radiology procedures (74Gy∗cm2 [Interquartile range 27-178Gy∗cm2]), followed by interventional cardiology (40Gy∗cm2 [22-78Gy∗cm2]) and electrophysiology procedures (13Gy∗cm2 [4-44Gy∗cm2], p<0.0001). In term of specific procedures, the highest DAP values were observed in structural or valvular cardiac procedures (134Gy∗cm2 [51-260Gy∗cm2]) whereas the lowest DAP values in pacemaker insertion (11Gy∗cm2 [4-28Gy∗cm2]). CONCLUSION: In this large multicenter study, the highest radiation exposure was observed in procedures performed by interventional radiologists. However, among specific procedures, structural or valvular cardiac procedures were associated with the highest radiation exposure.

Procedural Outcomes and Survival After Catheter Ablation of Ventricular Tachycardia in Relation to Electroanatomical Substrate in Patients With Nonischemic-Dilated Cardiomyopathy: The Role of Unipolar Voltage Mapping.

INTRODUCTION: In patients with ischemic cardiomyopathy the size of bipolar low-voltage areas (LVA) in electroanatomical maps (EAM) was associated with poorer outcomes after catheter ablation (CA) of ventricular tachycardia (VT). However, the effect of LVA size on the survival after VT ablation in patients with nonischemic dilated cardiomyopathy (NIDCM) has not been studied. METHODS AND RESULTS: In 55 patients with NIDCM (48 male, age 61 ± 16 years, ejection fraction 32 ± 13%) an EAM to delineate the bipolar and unipolar LVAs was performed in 52 (94.5%) patients endocardially, in 24 (43.6%) patients epicardially, and in 21 (38.2%) patients on both surfaces. Additionally, activation mapping of the VT was possible in 22 (40%) patients. CA with lines transecting the scar and targeting late potentials was performed in all patients. Complete VT noninducibility at the end was achieved in 40 (72.7%) patients. During the median follow-up of 22 (interquartile range IQR 6, 34) months, VT recurrences were observed in 30 (54.5%) and cardiac death in 14 (25.5%) patients. The ROC analysis revealed that the size of endocardial unipolar LVA (<8.3 mV) was associated with cardiac death (AUC 0.89, 95% CI 0.79-0.98, P <0.0001). UVA = 145 cm2 discriminates for cardiac death with 83% sensitivity and 78% specificity. Endocardial UVA > 145 cm2 was a predictor for cardiac death (adjusted HR = 6.9; P = 0.014) and UVA ≥ 54% (of total endocardial LV surface) for VT recurrence (adjusted HR = 3.5; P = 0.016). CONCLUSION: The size of endocardial unipolar LVA (<8.3 mV) was a strong and independent predictor for cardiac mortality and VT recurrence in patients with NIDCM.

Differentiating the origin of outflow tract ventricular arrhythmia using a simple, novel approach.

BACKGROUND: Numerous electrocardiographic (ECG) criteria have been proposed to identify localization of outflow tract ventricular arrhythmias (OT-VAs); however, in some cases, it is difficult to accurately localize the origin of OT-VA using the surface ECG. OBJECTIVE: The purpose of this study was to assess a simple criterion for localization of OT-VAs during electrophysiology study. METHODS: We measured the interval from the onset of the earliest QRS complex of premature ventricular contractions (PVCs) to the distal right ventricular apical signal (the QRS-RVA interval) in 66 patients (31 men aged 53.3 ± 14.0 years; right ventricular outflow tract [RVOT] origin in 37) referred for ablation of symptomatic outflow tract PVCs. We prospectively validated this criterion in 39 patients (22 men aged 52 ± 15 years; RVOT origin in 19). RESULTS: Compared with patients with RVOT PVCs, the QRS-RVA interval was significantly longer in patients with left ventricular outflow tract (LVOT) PVCs (70 ± 14 vs 33.4±10 ms, P < .001). Receiver operating characteristic analysis showed that a QRS-RVA interval ≥49 ms had sensitivity, specificity, and positive and negative predictive values of 100%, 94.6%, 93.5%, and 100%, respectively, for prediction of an LVOT origin. The same analysis in the validation cohort showed sensitivity, specificity, and positive and negative predictive values of 94.7%, 95%, 95%, and 94.7%, respectively. When these data were combined, a QRS-RVA interval ≥49 ms had sensitivity, specificity, and positive and negative predictive values of 98%, 94.6%, 94.1%, and 98.1%, respectively, for prediction of an LVOT origin. CONCLUSION: A QRS-RVA interval ≥49 ms suggests an LVOT origin. The QRS-RVA interval is a simple and accurate criterion for differentiating the origin of outflow tract arrhythmia during electrophysiology study; however, the accuracy of this criterion in identifying OT-VA from the right coronary cusp is limited.

Catheter ablation of ventricular tachycardia and mortality in patients with nonischemic dilated cardiomyopathy: can noninducibility after ablation be a predictor for reduced mortality?

BACKGROUND: Data on outcomes after catheter ablation of ventricular tachycardia (VT) in patients with nonischemic dilated cardiomyopathy (NIDCM) are insufficient. We aimed to investigate the effects of successful catheter ablation of VT on cardiac mortality in patients with NIDCM. METHODS AND RESULTS: One hundred two patients with NIDCM (86 men; mean age, 58.8±15.2 years; mean ejection fraction, 33.3±11.9%) underwent VT ablation. After catheter ablation, a programmed ventricular stimulation to test for success was performed. Complete VT noninducibility was achieved in 62 (61%) patients and partial success or failure in 32 (31%) patients. During 2 years of follow-up, VT recurrence was observed in 33 patients (53%) without inducible VTs and in 24 patients (75%) with inducible VT inducible (P=0.041). VT inducibility was associated with higher VT recurrence (adjusted hazard ratio, 1.84; 95% confidence interval, 1.08-3.13; P=0.025). The primary end point of all-cause mortality was reached in 9 patients (15%) with noninducible VTs versus 11 patients (34%) with inducible sustained VTs (P=0.026). VT inducibility was associated with all-cause mortality (adjusted hazard ratio, 2.73; 95% confidence interval, 1.003-7.43; P=0.049). CONCLUSIONS: In patients with NIDCM and recurrent sustained VTs, a complete ablation of all inducible VTs may be achieved in 60% of the cases. The complete noninducibility may be a preferable end point of ablation because it was associated with better long-term success. Importantly, if possible to achieve through ablation, a complete VT noninducibility was associated with reduction of the likelihood for all-cause mortality in patients with NIDCM.

Early referral for ablation of scar-related ventricular tachycardia is associated with improved acute and long-term outcomes: results from the Heart Center of Leipzig ventricular tachycardia registry.

BACKGROUND: The effects of time to referral for catheter ablation (CA) of scar-related ventricular tachycardia (VT) on acute success, VT recurrence, and cardiac mortality are unclear. METHODS AND RESULTS: We investigated 300 patients after CA of sustained VT. CA was performed within 30 days after the first documented VT in 75 (25%) patients (group 1), between 1 month and 1 year in 84 (28%) patients (group 2), and >1 year after the first VT occurrence in 141 (47%) patients (group 3). The end points were noninducibility of any VT after CA (acute success), VT recurrence and cardiac mortality after 2 years. Acute success was achieved in 66 (88%) patients in group 1, 68 (81%) in group 2, and in 99 (70.2%) in group 3 (P=0.008). During the 2-year follow-up period, VT recurred in 28 (37.3%) patients in group 1, 52 (61.9%) patients in group 2, and 91 (64.5%) patients in group 3 (P<0.0001). Recurrence-free survival was higher in group 1, as compared with group 2 (hazard ratio [HR], 1.85; P=0.009) and group 3 (HR, 2.04; P=0.001). No survival difference was observed between groups 1 and 2 (HR, 0.85; P=0.68) and groups 1 and 3 (HR, 1.13; P=0.73). ß-blocker therapy, VT of ischemic origin, and complete success were associated with VT-free survival. VT recurrence (HR, 1.91; P=0.037) predicted cardiac mortality. CONCLUSIONS: CA of scar-related VT performed within 30 days after the first documented VT was associated with improved acute and long-term success. VT recurrence, but not the early referral for CA, was associated with cardiovascular mortality.

Device monitoring of heart failure in cardiac resynchronization therapy device recipients: a single-center experience with a novel multivector impedance monitoring system.

OBJECTIVES: We investigated the performance of a new intrathoracic multivector impedance monitoring system for the prediction of heart failure events in consecutive device-implanted patients. METHODS: Eighty heart failure patients implanted with biventricular defibrillators with multivector impedance monitoring capability were prospectively enrolled. Clinical heart failure status and impedance data were assessed during follow-up and if patients presented with an alert or heart failure deterioration. RESULTS: During follow-up (8.0 ± 4.4 months), 56 events of device alert for fluid index increase were identified in 29 patients, and a total of 39 heart failure events (defined by worsening of heart failure signs and symptoms) occurred in 23 patients. The sensitivity and positive predictive value (PPV) for heart failure deterioration was 61.5 and 42.9%, respectively. False-positive alerts occurred in 23 of 80 patients (28.8%), for an episode rate of 0.60 a year. Among all clinical heart failure events, decompensation caused hospitalization in 13 cases (33.3%), seven of them were preceded by an alert condition (53.8%) resulting in a sensitivity of 53.8% and a PPV of 17.9%. CONCLUSION: The present study confirms the feasibility and clinical usefulness of this novel multivector impedance monitoring system. It would be worthwhile to perform larger studies to assess its actual clinical value in heart failure patients.

Work burden with remote monitoring of implantable cardioverter defibrillator: is it time for reimbursement policies?

AIMS: The efficacy and accuracy, as well as patients' satisfaction, of device remote monitoring are well demonstrated. However, the workload of remote monitoring management has not been estimated and reimbursement schemes are currently unavailable in most European countries. This study evaluates the workload associated with remote monitoring systems. METHODS: A total of 154 consecutive implantable cardioverter defibrillator patients (age 66±12 years; 86.5% men) with a remote monitoring system were enrolled. Data on the clinician's workload required for the management of the patients were analyzed. RESULTS: A total of 1744 transmissions were received during a mean follow-up of 15.3±12.4 months. Median number of transmissions per patient was 11.3. There were 993 event-free transmissions, whereas 638 transmissions regarded one or more events (113 missed transmissions, 141 atrial events, 132 ventricular episodes, 299 heart failure-related transmissions, 14 transmissions regarding lead malfunction and 164 transmissions related to other events). In 402 cases telephonic contact was necessary, whereas in 68 cases an in-clinic visit was necessary and in 23 of them an in-clinic visit was prompted by the manufacturer due to technical issues of the transmitter. During follow-up, 316 work hours were required to manage the enrolled patients. Each month, a total of 14.9 h were spent on the remote monitoring of 154 patients (9.7 h for 100 patients monthly) with approximately 1.1±0.15 h per year for each patient. CONCLUSION: The clinician's work burden is high in patients with remote monitoring. In order to expand remote monitoring in all patients, reimbursement policies should be considered.

Thrombus aspiration during primary angioplasty for cardiogenic shock.

We sought to assess the clinical efficacy of thrombus aspiration during primary percutaneous coronary interventions (PCI) in patients presenting with ST-elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS). We retrospectively selected 44 patients with CS out of a population of 842 STEMI patients treated with primary PCI at our Hospital between March 2003 and October 2007. Twenty-six patients died during hospital stay (59.1%, Group 1), whereas the remaining 18 were discharged (40.9%, Group 2). Post-procedural ST-segment resolution was greater (68.0%+/-35.6 vs. 43.0%+/-35.0; p=0.06) and in-hospital mortality was significantly lower (21.4% vs 76.6%; p<0.01) in patients treated by TA as compared to patients undergoing standard PCI. At multivariate logistic regression analysis, TA was the only variable independently associated with survival.