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.

Design and rationale of the Impact of MultiPoint pacing in CRT patients with reduced RV-to-LV delay (IMAGE-CRT) study.

BACKGROUND: Cardiac resynchronization therapy (CRT) is an established treatment in patients with heart failure and prolonged QRS duration. A biventricular device is implanted to achieve faster activation and more synchronous contraction of the ventricles. Despite the convincing effect of CRT, 30-40% of patients do not respond. We decided to investigate the role of multipoint pacing (MPP) in a selected group of patients with right ventricle (RV)-to-left ventricle (LV) intervals less than 80 ms that do not respond to traditional CRT. METHODS: We will enrol 248 patients in this patient-blinded, observational, clinical study aiming to investigate if MPP could decrease LV end-systolic volume (ESV) in patients with RV-to-LV interval less than 80 ms. MPP will be activated ON at implant in patients with RV-to-LV delay less than 80 ms and OFF in RV-to-LV at least 80 ms. At follow-up the activation of MPP will be related to CRT response. The primary study endpoint will be the responder rate at 6 months, defined as a decrease in LV ejection fraction, LV end-diastolic volume, LV end-systolic volume (LVESV) at least 15% from baseline. Secondary outcomes include 12 months relative percentage reduction in LVESV and a combined clinical outcome measure of response to CRT defined as the patient being alive, no hospitalization due to heart failure, and experiencing an improvement in New York Heart Association functional class (Composite-Score). CONCLUSION: Reducing the nonresponder rate continues to be an important goal for CRT.If an increase in reverse remodelling can be achieved by MPP, this study supports the conduct of larger trials investigating the role of MPP on clinical outcomes in selected patients treated, right now, only with traditional CRT. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02713308. Registered on 18 March 2016.

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.

Effect of right ventricular apical pacing in survivors of myocardial infarction.

BACKGROUND: Much information is available regarding the possible negative effects of long-term right ventricular (RV) apical pacing, which may cause worsening of heart failure. However, very limited data are available regarding the effects of RV pacing in patients with a previous myocardial infarction (MI). METHODS AND RESULTS: We screened 115 consecutive post-MI patients and matched a group of 29 pacemaker (PM) recipients with a group of 49 unpaced patients, for age, left ventricular (LV) ejection fraction, and site of MI. During a median follow-up of 54 months, echocardiograms showed a decrease in LV ejection fraction in the paced group, from 51 +/- 10 to 39 +/- 11 (P < 0.01), and a minimal change in the unpaced group, from 57 +/- 8 to 56 +/- 7 (P = 0.98). Similar change was observed in systolic and diastolic diameters and volumes. CONCLUSIONS: The study showed that, in post-MI patients, RV apical pacing was associated with a worsening of LV function, suggesting that, among MI survivors, the need for a PM is a marker of worse outcome.

End-diastolic wall thickness as a predictor of reverse remodelling after cardiac resynchronization therapy: a two-dimensional echocardiographic study.

BACKGROUND: The aim of this study was to evaluate whether in patients with ischemic heart failure (HF) with mechanical dyssynchrony the echocardiographic assessment of the extent of scarred ventricular tissue by end-diastolic wall thickness (EDWT) could predict reverse remodeling (RR) after cardiac resynchronization therapy (CRT). Recent studies using cardiac magnetic resonance imaging have shown that the burden of myocardial scar is an important factor influencing response to CRT, despite documented mechanical dyssynchrony. EDWT assessed by two-dimensional (2D) resting echocardiography is a simple and reliable marker to identify scar tissue in patients with ischemic left ventricular dysfunction. METHODS: Seventy-four patients with ischemic HF were evaluated 1 week before and 6 months after CRT. Inclusion criteria were New York Heart Association class III or IV, ejection fraction < 35%, QRS duration > 120 ms, and mechanical intraventricular dyssynchrony >/= 65 ms. The left ventricle was divided into 16 segments; left ventricular (LV) segments with EDWT < 6 mm were considered scarred. Percentage global scar area (GSA) was calculated by dividing the number of scarred LV segments by 16. RESULTS: RR, defined as a reduction of LV end-systolic volume >/= 15%, was found in 38 patients (51.4%) with ischemic HF. A significant inverse linear relationship was found between GSA and RR (r = -0.57; P = .0001). Mean percentage GSA was significantly higher in nonresponders (31.6 +/- 18% vs 6.4 +/- 11%; P < .001). GSA

Effect of pacing the right ventricular mid-septum tract in patients with permanent atrial fibrillation and low ejection fraction.

INTRODUCTION: Permanent right ventricular (RV) pacing leads have been traditionally implanted in the right ventricular apex (RVA). Nowadays, some deleterious effects of RVA pacing have been recognized. The aim of this study was to evaluate the effect of different sites of RV pacing in patients with permanent atrial fibrillation (AF) and low ejection fraction (LEF) needing a pacemaker (PM) implantation. METHODS: Two hundred seventy-three patients with permanent AF and EF <30% underwent a one-chamber rate responsive (VVIR) PM implant procedure. Patients were divided into two groups: Group A, including 113 patients with the pacing lead tip placed in the RV mid-septum, and Group B of 120 patients with the pacing lead tip placed at the apex of RV. All patients had clinical and Echo control after 1, 3, 6, 12, and 18 months after PM implantation to assess New York Heart Association (NYHA) class and EF. RESULTS: After 18 months, NYHA class changed in Group A from 2.9 +/- 0.4 at implant to 1.7 +/- 0.3 at 18 months (P = 0.01), and in Group B from 3.0 +/- 0.5 at implant to 3.3 +/- 0.6 at 18 months (P = n.s.). EF increased in Group A: 28 +/- 2% at implant, 33 +/- 1% at 18 months (P = 0.0125), while no significant changes were observed in Group B: at implant 27 +/- 2%, 26 +/- 2% at 18 months (P = n.s.). CONCLUSION: The present study suggests that more physiological pacing from the RV sept can improve EF and quality of life (QoL) in patients with permanent AF and low EF needing a PM.

Is it possible to create a linear lesion with no local electrograms? Comparison between a three-dimensional mapping system and conventional fluoroscopy for cavotricuspid isthmus ablation of typical atrial flutter.

OBJECTIVE: The aim of this prospective, randomised study was to evaluate the efficacy, safety and long-term outcomes of the complete disappearance of local electrograms along the linear lesion using the EnSite NavX three-dimensional mapping system as compared with conventional fluoroscopy for ablation of typical atrial flutter (AFL). METHODS: Seventy-three patients with spontaneous AFL episodes were randomised to undergo fluoroscopy-guided (group I, n=35) or EnSite NavX-guided (group II, n=38) ablation. When bidirectional isthmus block was achieved, the catheter was navigated back along the ablation line to assess the presence of local potentials along the lesion line. RESULTS: Bidirectional isthmus block was achieved in all patients. Mean total fluoroscopy time was 19.8 +/- 4.1 min in group I and 9.1 +/- 3.5 min in group II (P<0.001); mean fluoroscopy time required for radiofrequency ablation was 6.9 +/- 1.4 min in group I and 0.6 +/- 0.3 min in group II (P<0.001). During a follow-up of 16 +/- 9 months, three patients in group I (10%) experienced recurrence of AFL as opposed to none in group II (P<0.005). CONCLUSIONS: NavX technology allows accurate re-navigation of the lesion line to assess the presence of local potentials during an ablation procedure for typical AFL. Electroanatomic activation mapping can accurately identify gaps in the linear radiofrequency lesion with no AFL recurrence compared with 20% of recurrences after a standard procedure.

Is it possible to perform a linear lesion with no local electrograms using a three-dimensional mapping system for the ablation of typical atrial flutter?

AIMS: A randomized prospective study to evaluate the efficacy, safety and long-term outcomes of the complete disappearance of local electrograms along the linear lesion using the EnSite NavX three-dimensional mapping system compared to the conventional fluoroscopy-based mapping for the ablation of typical atrial flutter (AFL). METHODS: 83 patients with spontaneous AFL episodes were randomized to the conventional procedure (group I, 41 patients) or to the EnSite NavX three-dimensional mapping system (group II, 42 patients). When bidirectional block was achieved, a renavigation of the ablation line was performed to verify the absence of local potentials along the line. RESULTS: In all patients, bidirectional isthmus block was achieved. Total mean fluoroscopy time was 19.8 +/- 4.1 min and 9.1 +/- 3.5 min (p < 0.001) and radiofrequency (RF) mean fluoroscopy time was 6.9 +/- 1.4 min and 0.6 +/- 0.3 min (p < 0.001), respectively, in group I and II. During long-term follow-up of 16 +/- 9 months, there were 4 (10%) AFL recurrences in group I and 0 in group II (p < 0.005). CONCLUSION: NavX accurately renavigates the lesion line and verifies local potentials. The electro-anatomic activation map accurately identifies gaps in the RF lesion line and no recurrences were found compared with 10% recurrences after standard procedures for typical AFL.

VErapamil plus antiarrhythmic drugs reduce atrial fibrillation recurrences after an electrical cardioversion (VEPARAF Study).

AIMS: To evaluate the impact, on atrial fibrillation (AF) recurrences, of verapamil addition to a class IC or III antiarrhythmic drug in patients, with persistent AF, who underwent an electrical cardioversion (EC). METHODS AND RESULTS: Three hundred sixty-three patients were randomized to receive four different pre-treatment protocols: oral amiodarone (group A), oral flecainide (group F), oral amiodarone plus oral verapamil (group A+V), oral flecainide plus oral verapamil (group F+V). Patients who showed an AF recurrence within 3 months were assigned to the alternative group and underwent a second EC after 48h. During 3 months of follow-up, 89 patients (27.5%) had an AF recurrence. By univariate analysis, verapamil reduced AF recurrences if added to amiodarone or flecainide (from 35% to 20%, P=0.004). Applying Cox proportional hazards regression model, only the younger age, the shorter duration of AF, and the use of verapamil were predictor of maintenance of sinus rhythm after cardioversion. In patients with primary AF recurrence, verapamil addition to group A and F patients, significantly decreased secondary AF recurrence rate as compared to group A+V and F+V patients who stopped the verapamil therapy (68% vs 88%, P=0.03). CONCLUSIONS: The addition of verapamil to class IC or III antiarrhythmic drug significantly reduced the AF recurrences, that were more frequent in older patients and in patients with longer lasting AF; moreover, verapamil was effective in reducing the secondary AF recurrences, too.