Temporal association between drops in thoracic impedance and malignant ventricular arrhythmia: A longitudinal analysis of remote monitoring trends.

INTRODUCTION: Thoracic impedance (TI) drops measured by implantable cardioverter-defibrillators (ICDs) have been reported to correlate with ventricular tachycardia/fibrillation (VT/VF). The aim of our study was to assess the temporal association of decreasing TI trends with VT/VF episodes through a longitudinal analysis of daily remote monitoring data from ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds). METHODS AND RESULTS: Retrospective data from 2384 patients were randomized 1:1 into a derivation or validation cohort. The TI decrease rate was defined as the percentage of rolling weeks with a continuously decreasing TI trend. The derivation cohort was used to determine a TI decrease rate threshold for a ≥99% specificity of arrhythmia prediction. The associated risk of VT/VF episodes was estimated in the validation cohort by dividing the available follow-up into 60-day assessment intervals. Analyses were performed separately for 1354 ICD and 1030 CRT-D patients. During a median follow-up of 2.0 years, 727 patients (30.4%) experienced 3298 confirmed VT/VF episodes. In the ICD group, a TI decrease rate of >60% was associated with a higher risk of VT/VF episode in a 60-day assessment interval (stratified hazard ratio, 1.42; 95% confidence interval (CI), 1.05-1.92; p = .023). The TI decrease preceded (40.8%) or followed (59.2%) the VT/VF episodes. In the CRT-D group, no association between TI decrease and VT/VF episodes was observed (p = .84). CONCLUSION: In our longitudinal analysis, TI decrease was associated with VT/VF episodes only in ICD patients. Preventive interventions may be difficult since episodes can occur before or after TI decrease.

Patient acceptance of subcutaneous versus transvenous defibrillator systems: A multi-center experience.

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is an effective alternative to the transvenous ICD. No study has yet compared S-ICD and transvenous ICD by assessing patient acceptance as a patient-centered outcome. OBJECTIVE: To evaluate the patient acceptance of the S-ICD and to investigate its association with clinical and implantation variables. In patients with symptomatic heart failure and reduced ejection fraction (HFrEF), the acceptance of the S-ICD was compared with a control group of patients who received a transvenous ICD. METHODS: Patient acceptance was calculated with the Florida Patient Acceptance Survey (FPAS) which measures four factors: return to function (RTF), device-related distress (DRD), positive appraisal (PA), and body image concerns (BIC). The survey was administered 12 months after implantation. RESULTS: 176 patients underwent S-ICD implantation. The total FPAS and the single factors did not differ according to gender, body habitus, or generator positioning. Patients with HFrEF had lower FPAS and RTF. Younger patients showed better RTF (75 [56-94] vs. 56 [50-81], p = .029). Patients who experienced device complications or device therapies showed higher DRD (40 [35-60] vs. 25 [10-50], p = .019). Patients with HFrEF receiving the S-ICD had comparable FPAS, RTF, DRD, and BIC to HFrEF patients implanted with the transvenous ICD while exhibited significantly better PA (88 [75-100] vs. 81 [63-94], p = .02). CONCLUSIONS: Our analysis revealed positive patient acceptance of the S-ICD, even in groups at risk of more distress such as women or patients with thinner body habitus, and regardless of the generator positioning. Among patients receiving ICDs for HFrEF, S-ICD was associated with better PA versus transvenous ICD.

Access to magnetic resonance imaging of patients with magnetic resonance-conditional pacemaker and implantable cardioverter-defibrillator systems: results from the Really ProMRI study.

Aims: The Really ProMRI study evaluates magnetic resonance imaging (MRI) access for patients with cardiac implantable electronic devices (CIEDs) as well as the performance of magnetic resonance (MR)-conditional leads when undergoing MRI. Methods and results: Patients either with an MR-conditional pacemaker or implantable defibrillator (ICD) system or with at least a component (device or one or more leads) from an MR-conditional system, were asked to fill in a questionnaire when they were referred to a MR scan. The rate of prescription, denial, or execution of MR examinations was evaluated in a 1-year follow-up visit. In total, 555 patients [median age (interquartile range) 72.2 (62.2-78.6); 72% male] were enrolled, 49% (270) with a pacemaker, 51% (285) with an ICD system. Five-hundred and ten patients completed the follow-up period. A total of 37 MRI referrals were reported in 35 patients, with a consequent event rate of 7.0/100 patient-years (CI, 4.9-9.7). Fourteen were denied, while 23 [66%; (CI, 48-81%)] were performed. The number of patients with MR referrals was not statistically different between pacemaker and ICD groups (21 vs. 14; P = 0.178). The rate of scans performed was higher in the pacemaker subjects (19/23 vs. 4/14, P = 0.003), while it was similar between patients with or without a complete MR-conditional system (19/30 vs. 4/7, P = 0.606). Conclusion: In this study, we reported a 7.0/100 patient-year's event rate of MR prescriptions in CIED patients. Many examinations were denied, despite MR-conditional systems, especially in ICD patients. Regulatory and cultural changes are needed to allow wider access to MR imaging in CIED patients with MR-conditional systems.

Robotic-Assisted Epicardial Hybrid Ablation and Left Appendage Closure in Persistent Atrial Fibrillation: First European Experience.

Background: Pulmonary vein isolation is currently considered to be the gold standard for ablating paroxysmal atrial fibrillation. However, its efficacy is limited in patients with persistent atrial fibrillation. The convergent procedure has emerged as a hybrid ablation. This study aims, for the first time in the literature, to introduce a hybrid approach that includes epicardial ablation with cutting-edge robotic technology and subsequent electrophysiological study to verify and an endocardial ablation to complete the ablation lines. Methods: We present 18 cases of robotic-assisted epicardial hybrid ablation performed between April and December 2023 on patients with long-standing persistent atrial fibrillation (mean age: 64 ± 5 years; mean duration: 4 ± 2 years). All of the procedures were performed at "Humanitas Gavazzeni Hospital", Bergamo, Italy. Robot-assisted epicardial ablation performed using the "Epi-Sense AtriCure" device was guided by monitoring electrogram morphology and point-by-point impedance drop. This approach also included left atrial appendage occlusion and the disconnection of the ligament of Marshall. An electrophysiological study and endocardial ablation were planned three months after the procedure. Results: The procedure was successfully executed in all patients with no major complications and a mean operative time of 142 ± 22 min. None of the cases required conversion to full sternotomy or minithoracotomy. The procedure was performed in all cases without extracorporeal circulation and on a beating heart. Fifteen patients (83%) were extubated in the operating room. The length of stay in the intensive care unit was less than 24 h. Acute restoration of sinus rhythm was achieved in 12 out of the 18 patients (67%); the median duration of their hospital stay was two days. In the electrophysiological study, seven pts had sinus rhythm, two had atrial fibrillation, and one patient developed atrial flutter at 3-month follow-up. Patients underwent transcatheter ablation to complete the lesion set and, at the time of discharge, were all in sinus rhythm. Conclusions: In our initial experience, surgical atrial fibrillation ablation consisting of a unilateral thoracoscopic technique facilitated by a robotic platform and continuous EGM monitoring has proven to be safe and feasible. For the electrophysiological study at 3 months, completing the gaps in the surgical ablation lines could improve the clinical results of the technique in terms of sinus rhythm stability. However, mid- and long-term follow-up is required to demonstrate this.

Inappropriate therapies in modern implantable cardioverter-defibrillators: A propensity score-matched comparison between single- and dual-chamber discriminators in single-chamber devices THe sINGle lead Study (THINGS Study).

BACKGROUND: In patients with implantable cardioverter-defibrillators (ICDs), inappropriate therapies (ITs) are often caused by supraventricular tachyarrhythmias (SVTs). OBJECTIVE: We aimed to estimate the incidence of IT in modern single-lead ICDs. METHODS: The THINGS study enrolled patients with single-lead ICDs with 2 SVT discrimination modalities: dual chamber (DC) with an atrial floating dipole or single chamber (SC) with morphology criterion. All devices were programmed with 2-zone therapy: ventricular tachycardia (VT) zone from 170 beats/min with ≥15 seconds (≥36 beats) detection time and SVT discriminators; and ventricular fibrillation (VF) zone from 214 beats/min with ≥7 seconds (≥24 beats) detection time. The primary end point was the first occurrence of IT, adjudicated by an independent board. RESULTS: A total of 526 patients (median age, 66 years; 83% male), 183 (34.8%) with DC and 343 (65.2%) with SC discrimination, were observed for a median of 2.2 years. The incidence rate of IT was 4.2% (95% confidence interval [CI], 2.7%-6.4%) at 1 year and 7.1% (95% CI, 5.0%-9.9%) at 2 years. Younger age (adjusted hazard ratio, 0.97; 95% CI, 0.95-0.99; P = .013) and history of atrial fibrillation (adjusted hazard ratio, 2.67; 95% CI, 1.30-5.46; P = .007) were significantly associated with increased IT risk. In a propensity score-matched comparison, DC discrimination showed a trend toward reduced IT rates compared with SC discrimination in the VT zone (1-year incidence, 1.8% vs 3.5%; P = .105). CONCLUSION: High-rate VF cutoff and prolonged detection time programming resulted in a low IT rate in single-lead ICD patients with modern SVT discriminators. A trend favoring the DC system was observed in the VT zone.

Device-detected atrial sensing amplitudes as a marker of increased risk for new onset and progression of atrial high-rate episodes.

BACKGROUND: Atrial high-rate episodes (AHREs) are frequent in patients with cardiac implantable electronic devices. A decrease in device-detected P-wave amplitude may be an indicator of periods of increased risk of AHRE. OBJECTIVE: The objective of this study was to assess the association between P-wave amplitude and AHRE incidence. METHODS: Remote monitoring data from 2579 patients with no history of atrial fibrillation (23% pacemakers and 77% implantable cardioverter-defibrillators, of which 40% provided cardiac resynchronization therapy) were used to calculate the mean P-wave amplitude during 1 month after implantation. The association with AHRE incidence according to 4 strata of daily burden duration (≥15 minutes, ≥6 hours, ≥24 hours, ≥7 days) was investigated by adjusting the hazard ratio with the CHA2DS2-VASc score. RESULTS: The adjusted hazard ratio for 1-mV lower mean P-wave amplitude during the first month increased from 1.10 (95% confidence interval [CI], 1.05-1.15; P < .001) to 1.18 (CI, 1.09-1.28; P < .001) with AHRE duration strata from ≥15 minutes to ≥7 days independent of the CHA2DS2-VASc score. Of 871 patients with AHREs, those with 1-month P-wave amplitude <2.45 mV had an adjusted hazard ratio of 1.51 (CI, 1.19-1.91; P = .001) for progression of AHREs from ≥15 minutes to ≥7 days compared with those with 1-month P-wave amplitude ≥2.45 mV. Device-detected P-wave amplitudes decreased linearly during the 1 year before the first AHRE by 7.3% (CI, 5.1%-9.5%; P < .001 vs patients without AHRE). CONCLUSION: Device-detected P-wave amplitudes <2.45 mV were associated with an increased risk of AHRE onset and progression to persistent forms of AHRE independent of the patient's risk profile.

Biophysical Behavior of Very High-Power Short-Duration Radiofrequency Ablation in Pulmonary Vein Isolation: Fast but Gently-Implications for a Successful Procedure.

The very high-power short-duration (vHP-SD) ablation strategy is an alternative for pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF). However, the acute procedural biophysical behavior of successful lesion creation by means of this technique is still unexplored. We performed a retrospective case-control study aimed at evaluating the behavior of vHP-SD ablation parameters with the QDOT MICRO™ ablation catheter (Biosense Webster) compared with standard radiofrequency (RF) ablation with the THERMOCOOL SMARTTOUCH® ablation catheter. Twenty consecutive cases of symptomatic PAF treated with the QDOT MICRO™ ablation catheter from December 2022 to March 2023 were compared with cases treated with the standard technique. The acute procedural success of PVI was obtained in all cases with 2192 RF applications, and no adverse events occurred. Compared with the controls, vHP-SD cases featured a significant reduction in procedural time (47 ± 10 vs. 56 ± 12 min, p = 0.023), total RF time (3.8 [CI 3.4-4.6] vs. 21.2 [CI 18.4-24.9] min, p < 0.001), ablation phase time (25 ± 5 vs. 39 ± 9 min, p < 0.001), and irrigation volume (165 [CI 139-185] vs. 404 [CI 336-472] ml, p < 0.001). In vHP-SD RF ablation, a contact force of 5 g minimum throughout the 4 s of RF application appeared to be statistically significant in terms of an impedance drop of at least 10 Ohm (OR 2.63 [CI 1.37; 5.07], p = 0.003). In contrast, in the control group, the impedance drop depended linearly on the contact force. This suggests a different biophysical behavior of vHP-SD ablation. A maximum temperature and minimum contact force of >5 g independently predicted an effective impedance drop in vHP-SD. Increasing the contact force over 5 g during 4 s of vHP RF application might not be necessary to achieve a successful lesion.

Cardiac resynchronization therapy defibrillators in patients with permanent atrial fibrillation.

AIMS: There are conflicting data on the benefit of cardiac resynchronization therapy (CRT) in heart failure (HF) patients with permanent atrial fibrillation (AF). We aimed to compare patient outcomes according to the presence or absence of permanent AF at device implantation. METHODS AND RESULTS: We retrospectively analysed remote monitoring data from 1141 CRT defibrillators. Propensity score with inverse-probability weighting method was used to balance AF and sinus rhythm (SR) groups. Analysis endpoints included total mortality, appropriate defibrillation shocks, and CRT percentage. There were 229 patients (20.1%) in the AF group and 912 patients (79.9%) in the SR group. Compared with SR patients, AF patients were older (median age, 77 vs. 72 years, P < 0.001), more frequently male (82.5% vs. 75.5%, P = 0.02), and had higher heart rate (75.7 vs. 71.0 b.p.m., P < 0.001). Of the 229 AF patients, 162 (70.7%) received suboptimal CRT (<98%) and 67 (29.3%) had adequate CRT (≥98%). During a median follow-up of 24 months, total mortality did not differ between AF and SR groups (propensity-score-weighted hazard ratio, HR 1.32 [95% confidence interval, 0.82-2.15], P = 0.25). The risk of appropriate shocks was significantly higher in the AF group with <98% CRT than in the SR group (weighted-HR, 1.99 [1.21-3.26], P = 0.006) and was similar in the AF group with ≥98% CRT versus the SR group (1.29 [0.66-2.53], P = 0.45). During follow-up, sinus rhythm was recovered in 23 patients in the AF group (10%) after a median time of 106 (42-256) days. The rate of sinus rhythm recovery in the AF group was 4.5 (95% CI, 2.8-6.7) per 100 patient-years; the rate of permanent AF occurrence in the SR group was 2.5 (95% CI, 1.9-3.3) per 100 patient-years. CONCLUSIONS: Although mortality was similar across patient groups, patients with permanent AF and suboptimal CRT had twofold higher risk of appropriate shocks than SR patients or AF patients with CRT ≥ 98%.

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.

A radial global dyssynchrony index as predictor of left ventricular reverse remodeling after cardiac resynchronization therapy.

BACKGROUND: Cardiac mechanical efficiency requires that opposing left ventricular regions are coupled both in shortening and lengthening during the same phase of cardiac cycle. Aim of this study was to evaluate whether global measures of mechanical dyssynchrony are able to predict reverse remodeling of the left ventricle in patients receiving cardiac resynchronization therapy (CRT). METHODS: Sixty-two patients underwent a clinical examination, including New York Heart Association class evaluation and 6-minute walking distance and both echocardiographic study before and 6 months after CRT. Intraventricular dyssynchrony was evaluated by two-dimensional strain echocardiography, measuring the amount of uncoordinated contraction and relaxation between septum and free wall for both longitudinal and radial function and was presented as the longitudinal global dyssynchrony index (LGDI) and the radial global dyssynchrony index (RGDI). Reverse remodeling was defined by a left ventricular end systolic volume reduction >or= 15%. RESULTS: After CRT 39 patients showed reverse remodeling. In this group, RGDI (0.74 +/- 0.26 vs 0.32 +/- 0.30; P = 0.0001) and LGDI (0.52 +/- 0.28 vs 0.30 +/- 0.24; P = 0.002) were significantly higher than in nonresponders. A receiver-operating characteristic curve analysis showed that RGDI >0.47 and LGDI >0.34 had a sensitivity and a specificity to predict reverse remodeling of 87% and 74%, 82%, and 74%, respectively. Stepwise forward multiple logistic regression analysis showed that RGDI (O.R.:13.4; 95%C.I.:4.2-120.5; P < 0.0001) was an independent determinant of a positive response to CRT. CONCLUSION: A radial global dyssynchrony index predicts left ventricular reverse remodeling after CRT.

Presence of left ventricular contractile reserve, evaluated by means of dobutamine stress-echo test, is able to predict response to cardiac resynchronization therapy.

INTRODUCTION: We evaluated whether the dobutamine stress-echo test can select responders to cardiac resynchronization therapy (CRT). Up to 50% of patients do not respond to CRT. Lack of response may be due to a significant amount of scar or fibrotic tissue at myocardial level. METHODS AND RESULTS: We studied 42 CRT patients. After clinical and echocardiographic evaluation, all patients underwent a dobutamine stress-echo test to assess contractile reserve. Cut-off for the test was an increase of 25% of the left ventricular ejection fraction. Patients were implanted with a CRT-defibrillator and followed up at 6 months. Cut-off for CRT response was a reduction of 15% of left ventricular end-systolic volume. Twenty-five patients responded to CRT; all of them showed presence of contractile reserve. The test showed a sensitivity of 100% and a specificity of 88%. CONCLUSION: Contractile reserve was a strong predictive factor of response to CRT in the studied population.

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.

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