Effects of COVID-19 lockdown on arrhythmias in patients with implantable cardioverter-defibrillators in southern Italy.

Background: The effects of lockdown on non-COVID patients are varied and unexpected. The aim is to evaluate the burden of cardiac arrhythmias during a lockdown period because of COVID-19 pandemics in a population implanted with cardiac defibrillators and followed by remote monitoring. Methods: In this retrospective, multicentre cohort study, we included 574 remotely monitored implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) recipients implanted before January 1, 2019, at seven hospitals in the Campania region, comparing the burden of arrhythmias occurred during the lockdown period because of COVID-19 epidemics (from March 9 to May 1, 2020) with the arrhythmias burden of the corresponding period in 2019 (reference period). Data collection was performed through remote monitoring. Results: During the lockdown period, we observed ventricular tachyarrhythmias (ventricular tachycardia or fibrillation) in 25 (4.8%) patients while in seasonal reference period we documented ventricular tachyarrhythmias in 12 (2.3%) patients; the comparison between the periods is statistically significant (P < .04). Atrial arrhythmias were detected in 38 (8.2%) subjects during the lockdown period and in 24 (5.2%) during the reference period (P < .004). Conclusion: In seven hospitals in the Campania region, during the pandemic lockdown period, we observed a higher burden of arrhythmic events in ICD/CRT-D patients through device remote monitoring.

A New System for Assessing Visual Disability Using a Digital Visor.

BACKGROUND: Considering the lack of universally accepted visual requirements for driving and for defining various grades of visual disability, the aim of this study is to propose a new method that provides a numerical score resulting from a combined assessment of the visual field and visual acuity loss obtained using a digital technology visor. METHODS: This study presents a new system for calculating the percentage of visual disability by combining binocular visual acuity and binocular visual field assessments. A new Global Vision Evaluation System digital technology visor uses standardized, reproducible criteria to produce well-defined, numerically expressed test results. Through a specific algorithm, the device produces a numerical value expressing the percentage of visual disability. RESULTS: Eighty-six subjects with various types of visual impairment underwent visual acuity and visual field test examinations carried out employing both traditional methods and the new digital visor. The two methods provided homogeneously similar results regarding the positioning of the subjects on the visual disability scale. CONCLUSIONS: The new digital visor seems to be a valid method to ensure that visual disability assessments are more homogeneous and reliable, and that, consequently, the resources available for this purpose are more fairly distributed.

[ETNA-AF study: Italian baseline data and comparison with the European population in atrial fibrillation patients treated with edoxaban]. / Lo studio ETNA-AF: dati basali della popolazione italiana e confronto con la popolazione europea nei pazienti affetti da fibrillazione atriale trattati con edoxaban.

The introduction of direct oral anticoagulants (DOACs) has been the main therapeutic revolution in the last 20 years. Four molecules have been approved for the thromboembolic prophylaxis in patients with non-valvular atrial fibrillation (AF). After the publication of phase 3 clinical trials, many studies evaluating DOAC safety and efficacy in daily clinical practice have been published. Edoxaban is the latest DOAC available on the market, based on the results of the ENGAGE AF-TIMI 48 trial. The phase 4 ETNA-AF (Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation) observational study was designed with the aim to confirm the results of the pivotal clinical trial in routine care in unselected patients with AF. This registry involved several sites and enrolled a large population in Europe and in Italy (13 980 and 3512 patients, respectively). The broad spectrum of patients will allow to have an overview of the characteristics of the AF population and to make a comparison with previous national registries and between different European realities.

Mapping and Ablation of Retrograde Conduction During a Nearly Incessant Pacemaker-mediated Tachycardia in a Patient with Third-degree Atrioventricular Block.

Patients with third-degree atrioventricular block implanted with a dual-chamber pacemaker in DDD mode can develop pacemaker-mediated tachycardias if retrograde ventriculoatrial (VA) conduction is present. Programming a long post-VA refractory period to avoid tachycardia initiation can be contraindicated if these patients have a good atrial response from exercise testing and require a high maximum tracking rate to allow for a proper response to sensed atrial rhythms. We report a case of a patient in whom mapping and ablation of retrograde conduction during the pacemaker-mediated rhythm was the only solution to allow both the programming of a high tracking rate and the elimination of tachycardia induction.

Nonvitamin K Antagonist Oral Anticoagulants Use in Patients with Atrial Fibrillation and Bioprosthetic Heart Valves/Prior Surgical Valve Repair: A Multicenter Clinical Practice Experience.

This is an observational study to investigate the efficacy and safety of nonvitamin K antagonist oral anticoagulants (NOACs) in atrial fibrillation (AF) patients with bioprosthetic valves or prior surgical valve repair in clinical practice. A total of 122 patients (mean age: 74.1 ± 13.2; 54 females) with bioprosthetic heart valve or surgical valve repair and AF treated with NOACs were included in the analysis. The mean CHA2DS2-VASc (Congestive heart failure, Hypertension, Age >75 years, Diabetes mellitus, prior Stroke or transient ischemic attack, Vascular disease) and HAS-BLED (Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile INR [international normalized ratio], Elderly, Drugs or alcohol) score values were 3.6 ± 1.2 and 2.6 ± 1.4, respectively. Of the total study population, 28.6% was taking apixaban 5 mg twice daily (BID), 24.5% apixaban 2.5 mg BID, 18% dabigatran 150 mg BID, 13% dabigatran 110 mg BID, 9.8% rivaroxaban 20 mg daily (QD), and 5.7% rivaroxaban 15 mg QD. Also, 92% of the study population previously had warfarin replaced with NOACs due to lack compliance and labile INR control (time in therapeutic range < 60%). NOAC therapy for AF was started on average 934 ± 567 days after bioprosthetic heart valve implantation or surgical repair for an average duration of 835 ± 203 days. The study population included 24 (19.6%) patients with bioprosthetic mitral valve, 52 (43%) patients with bioprosthetic aortic valve, 41 (33.6%) patients with previous surgical mitral repair, 5 (4%) patients with previous surgical aortic repair, and concomitant use of NOACs. All patients were evaluated for thromboembolic events (ischemic stroke, transient ischemic attack, systemic embolism) as well as major bleeding events during the follow-up period. In our study population, we recorded a low mean annual incidence of thromboembolism (0.8%) and major bleeding (1.3%). According to our data, anticoagulation therapy with NOACs seems to be an effective and a safe treatment strategy for nonvalvular AF patients with bioprosthetic valves or prior surgical valve repair.

Economic impact of remote monitoring after implantable defibrillators implantation in heart failure patients: an analysis from the EFFECT study.

AIMS: Heart failure (HF) patients with implantable cardioverter-defibrillators (ICD) require admissions for disease management and out-patient visits for disease management and assessment of device performance. These admissions place a significant burden on the National Health Service. Remote monitoring (RM) is an effective alternative to frequent hospital visits. The EFFECT study was a multicentre observational investigation aiming to evaluate the clinical effectiveness of RM compared with in-office visits standard management (SM). The present analysis is an economic evaluation of the results of the EFFECT trial. METHODS AND RESULTS: The present analysis considered the direct consumption of healthcare resources over 12-month follow-up. Standard tariffs were applied to hospitalizations, in-office visits and remote device interrogations. Economic comparisons were also carried out by means of propensity score (PS) analysis to take into account the lack of randomization in the study design. The analysis involved 858 patients with ICD or CRT-D. Of these, 401 (47%) were followed up via an SM approach, while 457 (53%) were assigned to RM. The rate of hospitalizations was 0.27/year in the SM group and 0.16/year in the RM group (risk reduction =0.59; P = 0.0004). In the non-adjusted analysis, the annual cost for each patient was €817 in the SM group and €604 in the RM group (P = 0.014). Propensity score analysis, in which 292 RM patients were matched with 292 SM patients, confirmed the results of the non-adjusted analysis (€872 in the SM group vs. €757 in the RM group; P < 0.0001). CONCLUSION: There is a reduction in direct healthcare costs of RM for HF patients with ICDs, particularly CRT-D, compared with standard monitoring. CLINICAL TRIAL REGISTRATION: http://clinicaltrials.gov/Identifier, NCT01723865.

[Management of thromboembolic risk in patients with atrial fibrillation in Italy: follow-up data from the PREFER in AF European Registry]. / La gestione del rischio tromboembolico nei pazienti con fibrillazione atriale in Italia: dati al follow-up del Registro Europeo PREFER in AF.

BACKGROUND: Baseline data of the PREFER in AF (PREvention oF thromboembolic events - European Registry in Atrial Fibrillation) Registry have shown undertreatment of patients with atrial fibrillation (AF), particularly in Italy, where greater difficulties in the management of antithrombotic drugs compared with other European countries were also observed. The aim of the follow-up evaluation was to verify the trends of examined variables after 1 year. METHODS: Clinical features, patterns of prescriptions and patient adherence to guidelines, quality-of-life and treatment satisfaction variables were evaluated at follow-up, similarly to baseline. RESULTS: In Italy, 88% of patients originally enrolled completed the 1-year follow-up. The incidence of major cardiovascular events was lower than at baseline (12.6 vs 30.8%, p<0.0001), but was higher compared with the European mean (12.6 vs 10.4%, p=0.0006). In particular, the incidence of heart failure (5.1 vs 3.6%, p=0.0003) and transient ischemic attacks (1.4 vs 0.7%, p<0.0001) were more frequent in Italy; on the other hand, the incidence of major bleeding was lower in Italy compared with the European mean (1.6 vs 2.4, p=0.0168). Patients with a high thromboembolic risk (CHA 2DS2-VASc ≥2) were >80%, similarly to baseline, with a mean CHA2DS2-VASc score of 3.3. However, about one fourth of high-risk patients continued not to be treated with anticoagulant drugs, and treated patients at follow-up were fewer than at baseline (65.1 vs 72.6%, p<0.0001). The percentage of patients treated with non-vitamin K antagonist oral anticoagulants (NOACs) was increased at follow-up compared with baseline (3.3 vs 0.3%, p<0.0001), although lower than the European mean (12.6 vs 6.1%, p<0.0001). The number of INR measurements was higher and related to a higher time in therapeutic range (TTR), compared with baseline, and exceeded the European mean TTR. However, similarly to baseline, a higher difficulty in managing anticoagulant therapy and a lower level of satisfaction for treatment was reported in Italian patients compared with the rest of Europe. CONCLUSIONS: The Italian data of the PREFER in AF Registry at 1-year follow-up continue to demonstrate undertreatment of patients with AF at increased risk of stroke and a high grade of unsatisfaction for anticoagulant treatment. The low percentage of patients treated with NOACs did not allow the evaluation of their impact on clinical events and acceptance of therapy.

Next Generation Sequencing and Linkage Analysis for the Molecular Diagnosis of a Novel Overlapping Syndrome Characterized by Hypertrophic Cardiomyopathy and Typical Electrical Instability of Brugada Syndrome.

BACKGROUND: Familial hypertrophic cardiomyopathy (HCM) is an autosomal dominant inherited disorder; mutations in at least 20 genes have been associated. Brugada syndrome (BrS) is an autosomal dominant inherited disorder caused by mutations mainly in theSCN5Agene. A new clinical entity that consists of HCM, typical electrical instability of BrS and sudden death (SD), is described. METHODS AND RESULTS: The family was constituted by 7 members, 4 of who presented clinical features of HCM and electrical instability of BrS. The clinical presentation of proband was ventricular fibrillation. All members were clinically evaluated by physical examination, 12-lead electrocardiography, 2-dimensional echocardiography, stress test, electrocardiogram Holter, flecainide test, and electrophysiological study. An integrated linkage analysis and next generation sequencing (NGS) approach was used to identify the causative mutation. Linkage with the α-tropomyosin (TPM1) gene on chromosome 15q22 was identified. The NGS study identified a missense mutation within theTPM1gene (c.574G>A; p.E192K), exactly located in a binding domain with polycystin-2 protein. No other pathogenic mutations were identified. CONCLUSIONS: This is the first report of an association between HCM and BrS, and the first to use a combined approach of linkage and NGS to identify a causative mutation in SD. The present study expands the clinical spectrum of disorders associated with theTPM1gene and may be useful to report novel mechanisms of electrical instability in HCM and BrS.

[Management of thromboembolic risk in patients with atrial fibrillation in Italy: baseline data from the PREFER in AF European Registry]. / La gestione del rischio tromboembolico nei pazienti con fibrillazione atriale in Italia: dati al basale del Registro Europeo PREFER in AF.

BACKGROUND: Atrial fibrillation (AF) is a common heart rhythm disorder associated with an increased risk of stroke, heart failure and death. Although available evidence supports the administration of oral anticoagulants with respect to other treatment options to prevent thromboembolism, the use of oral anticoagulation therapy remains suboptimal. The PREFER in AF registry was conducted to evaluate patterns of prescriptions and patient adherence to guidelines, clinical features, quality of life and treatment satisfaction. METHODS: The PREFER in AF registry enrolled consecutive patients with AF recruited in high-volume cardiology centers, with AF documented during the previous 12 months. Patients were assessed at baseline and at 1-year follow-up. The present report provides Italian baseline data compared with data from other European countries participating in the registry. RESULTS: The registry enrolled 1888 Italian patients (out of 7243 in Europe), with an average age of 70.9 years. Main comorbidities included hypertension (73.5%), dyslipidemia (38.7%) and obesity (21.9%). The risk of thromboembolism was assessed using the CHA2DS2-VASc score, according to which only 4.7% of Italian patients scored 0, whereas 11.3% scored 1 and 84% scored ≥2. Italy is the Western European country with the lowest use of vitamin K antagonists (71.6%; average rate in Europe: 78.3%) and the highest average INR measurements, whereas time in therapeutic range is 72.2%, lower than in any other Western European country with the exception of Spain. Most Italian patients are unsatisfied with treatment, and only 36% report no difficulties in taking anticoagulation therapy compared with 70.3% of patients in other Western European countries. CONCLUSIONS: Among Western European countries included in the registry, Italy has the lowest prescription rate of vitamin K antagonists and the highest rate of INR measurements. Italian patients also report lower levels of satisfaction with treatment and a higher subjective difficulty in managing anticoagulation therapy. The new oral anticoagulants may favor treatment management, thus having the potential of improving medication adherence and persistence as well as quality of life.

A randomized study of cardiac resynchronization therapy defibrillator versus dual-chamber implantable cardioverter-defibrillator in ischemic cardiomyopathy with narrow QRS: the NARROW-CRT study.

BACKGROUND: Current recommendations require a QRS duration of ≥120 ms as a condition for prescribing cardiac resynchronization therapy (CRT). This study was designed to test the hypothesis that patients with heart failure (HF) of ischemic origin, current indications for defibrillator implantation, and QRS <120 ms may benefit from CRT in the presence of marked mechanical dyssynchrony. METHODS AND RESULTS: Patients with intraventricular dyssynchrony on echocardiography were randomly assigned to CRT or dual-chamber defibrillator implantation (CRT defibrillator and dual-chamber implantable cardioverter-defibrillator arm, respectively). The primary end point was the HF clinical composite response, which scores patients as improved, unchanged, or worsened. The secondary end point was the cumulative survival from HF hospitalization and HF death. An additional secondary end point was the composite of HF hospitalization, HF death, and spontaneous ventricular fibrillation. Twenty-three of 56 patients with CRT defibrillator showed an improvement in their clinical composite response at 1 year, compared with 9 of 55 patients with dual-chamber implantable cardioverter-defibrillator (41% versus 16%; P=0.004). After a median follow-up of 16 months, the CRT defibrillator arm showed a nonsignificant higher survival from HF hospitalization and HF death (P=0.077), and a significantly higher survival from the combined end point of HF hospitalization, HF death, and spontaneous ventricular fibrillation (P=0.028). CONCLUSIONS: In this comparison of CRT defibrillator and dual-chamber implantable cardioverter-defibrillator, CRT improved clinical status in some patients with ischemic cardiomyopathy, mild-to-moderate symptoms, narrow QRS duration, and mechanical dyssynchrony on echocardiography. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov. Unique identifier: NCT01577446.

Ablating the ventricular insertion of atrio-fascicular Mahaim fiber: what selection criteria should we use?

We reported a patient who underwent RF ablation of the distal insertion of an atrio-fascicular accessory pathway with decremental properties because of inability to map a suitable potential alongside the tricuspid annulus. Small, discrete potentials resembling those of purkinje fiber were found at right ventricular apex, all these potentials showed early activation during tachycardia preceding the QRS onset of various degrees. Pace mapping helped to localize the presumed main distal insertion of the atrio-fascicular AP in a region where a damage of the His-purkinje system may ensue. This case report describes catheter ablation of an atriofascicular accessory pathway by targeting its distal (ventricular) insertion site.

Ablating the ventricular insertion of atrio-fascicular mahaim fiber: could be performed safely?

We report a patient who underwent radiofrequency ablation of the distal insertion of an atrio-fascicular accessory pathway with decremental properties because of inability to map a suitable potential alongside the tricuspid annulus. Small, discrete potentials resembling those of Purkinje fiber were found at right ventricular apex. All these potentials showed early activation during tachycardia preceding the QRS onset of various degree. Pace mapping helped to localize the presumed main distal insertion of the atrio-fascicular accessory pathway in a region where damage of the His-purkinje system may ensue. This case report describes catheter ablation of an atriofascicular accessory pathway by targeting its distal (ventricular) insertion site.