Search

The historical restriction of magnetic resonance imaging (MRI) for patients with cardiac implantable electronic devices (CIEDs) has been lifted by certified MRI-conditional systems in recent years. Mixed-brand CIED systems consisting of a generator from one manufacturer and at least one lead from another manufacturer are not certified for MRI. We evaluated the temporal trend in the prevalence of mixed-brand systems in the era of MRI-conditional systems. Data were analyzed on 5853 CIEDs implanted de novo between 2012 and 2022 in 81 Italian centers linked to the nationwide Home Monitoring Expert Alliance network. The percentage of mixed-brand implants was calculated by device type (pacemaker, implantable cardioverter-defibrillator [ICD], cardiac resynchronization therapy [CRT] device) and over time. A mixed-brand system was implanted in 4.1% (95% CI, 3.6-4.6%) of analyzed patients or, by device type, in 4.5% (3.5-5.7%) of pacemaker patients, 1.1% (0.7-1.7%) of ICD patients, and 6.8% (5.7-7.9%) of CRT pacemaker/defibrillator patients (p < 0.001). Prevalence of mixed-brand implants exhibited significant temporal fluctuations, first declining from 6.6% (2012-2014) to 1.3% (2019), and then increasing to 5.1% (2022). Temporal changes were statistically significant for pacemakers (p < 0.001) and CRT devices (p = 0.001), but not for ICDs (p = 0.438). In the decade between 2012 and 2022, mixed-brand CIED systems were more prevalent in patients treated with pacemakers and CRT devices than in ICD recipients. A decline in the prevalence of mixed-brand systems was observed after the introduction of MRI-conditional systems, reaching a minimum in 2019, followed by a progressive increase in the subsequent years., (© 2024. The Author(s).)

Aims: Estimation of left ventricular (LV) filling pressures in patients with a history of atrial fibrillation (AF) is challenging due to lack of reliable parameters. This study investigates the association between cardiac structure and function and invasive mean left atrial pressure (LAP)., Methods and Results: This is a multi-centre prospective study enrolling patients undergoing transcatheter ablation for AF. The invasive measurement of LAP was performed at the time of the procedure while the echocardiography within the previous 24 h. A mean LAP ≥ 15 mmHg was considered as increased. Overall, 101 patients were included (mean age 65.8 ± 8.5 years, 68% male, mean LV ejection fraction 56.6 ± 8.0%). No significant differences regarding clinical characteristics were detected between the group of patients with normal (n = 47) or increased LAP (n = 54). The latter showed lower values of LV global longitudinal strain, larger left atrial volumes (LAVs) and worse right ventricular (RV) function. After multivariable adjustment, higher E/e' ratio (P = 0.041) and minimal LAV index (LAVI min) (P = 0.031), lower peak atrial longitudinal strain (P = 0.030), and RV free wall longitudinal strain (P = 0.037), but not maximal LAV index (LAVI max) (P = 0.137), were significantly associated with mean LAP. The associations were not modified by cardiac rhythm. Overall, LAVI min showed the best diagnostic accuracy to predict elevated LAP (area under the curve 0.703)., Conclusion: LA structure and function assessment well correlates with mean LAP in patients with a history of AF. These measures may be used in the assessment of filling pressure in these patients., Competing Interests: Conflict of interest: None declared., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Aims: Guidelines recommend insertable cardiac monitor (ICM) in the early phases of the evaluation of unexplained syncope (US) syncope, when an arrhythmic etiology is suspected. We examined the diagnostic yield of the last generation ICM (LG-ICM) to establish the causes of US, by assessing in the clinical practice the incidence of: relevant arrhythmia diagnosis, syncope recurrences and CM-guided cardiac electronic device (CIED) implantation. We investigated also baseline patient characteristics associated to an increased risk of relevant arrhythmias and of syncope recurrence., Methods: Data prospectively collected from consecutive patients receiving LG-ICM for investigation of US or presyncope in our institution between November 2020 and January 2023 were analyzed., Results: A total of 109 patients (mean age 64.4 ± 16.1 years, 40.4% women) with US or pre-syncope episodes underwent implantation of the LG-ICM. During a mean follow-up of 11.7 ± 8.1 months, LG-ICM diagnostic yield was 42%. In particular, LG-ICM detected cardiac arrhythmias in 29 (27%) patients (in 6 out of them during a syncope recurrence) and to exclude the arrhythmic origin of the syncope in additional 19 (17%) patients. LG-ICM guided the implantation of a CIED in 16 (15%) US patients, due to the diagnosis of asystole or severe bradycardia. Age ≥ 65 years (p = 0.012) and atrial arrhythmia history (p = 0.004) are significant independent predictors of arrhythmic diagnoses performed by LG-ICM, while CAD is predictor of syncope recurrence (bordering on statistical significance, p = 0.056)., Conclusions: The diagnostic yield of LG-ICM in US syncope is comparable to those of ILR and previous generation ICM. The advantages of LG-ICM should be sought in lower hospital workload necessary to manage ICM data. Age ≥ 65 years and atrial arrhythmia history are independent predictors of significant ICM-detected arrhythmias., Competing Interests: Declaration of competing interest All authors have no conflicts of interest to disclose., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: The H 2 FPEF and the HFA-PEFF scores have become useful tools to diagnose heart failure with preserved ejection fraction (HFpEF). Their accuracy in patients with a history of atrial fibrillation (AF) is less known. This study evaluates the association of these scores with invasive left atrial pressure (LAP) and the additional value of cardiac measures., Methods: This is a multicenter observational prospective study involving patients undergoing ablation of AF. Patients with left ventricular ejection fraction (LVEF) < 40%, congenital cardiopathy, any severe cardiac valve disease and prosthetic valves were excluded. Elevated filling pressure was defined as a mean LAP ≥15 mmHg., Results: A total of 135 patients were enrolled in the study (mean age 65.2 ± 9.1 years, 32% female, mean LVEF 56.9 ± 7.9%). Patients with H 2 FPEF ≥ 6 or HFA-PEFF ≥5 had higher values of NTproBNP and more impaired cardiac function. However, neither H 2 FPEF nor HFA-PEFF score showed a meaningful association with elevated mean LAP (respectively, OR 1.05 [95%CI 0.83-1.34] p = 0.64, and OR 1.09 [95%CI: 0.86-1.39] p = 0.45). The addition of LA indexed minimal volume (LAVi min) improved the ability of the scores (baseline C-statistic 0.51 [95%CI 0.41-0.61] for the H 2 FPEF score and 0.53 [95%CI 0.43-0.64] for the HFA-PEFF score) to diagnose elevated filling pressure (H 2 FPEF + LAVi min: C-statistic 0.70 [95%CI 0.60-0.80], p-value = 0.005; HFA-PEFF + LAVi min: C-statistic 0.70 [95%CI 0.60-0.80], p-value = 0.02)., Conclusion: In a cohort of patients with a history of AF, the use of the available diagnostic scores did not predict elevated mean LAP. The integration of LAVi min improved the ability to correctly identify elevated filling pressure., Competing Interests: Declaration of competing interest The authors report no relationships that could be construed as a conflict of interest., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Introduction: Transvenous lead extraction (TLE) is generally considered a safe procedure, albeit not without risks. While gender-based disparities have been noted in short-term outcomes following TLE, a notable gap exists in understanding the long-term consequences of this procedure. The objective of this analysis was to investigate sex differences in both acute and long-term outcomes among patients who underwent TLE at a tertiary referral center., Methods: In this retrospective cohort study, consecutive patients who underwent TLE between January 2014 and January 2016 were enrolled. The primary outcome comprised a composite of all-cause mortality and need for repeated TLE procedures. Secondary outcomes included fluoroscopy time, lead extraction techniques, success rates, and major and minor complications. Results were compared between female and male cohorts., Results: The study population comprised 191 patients (median age, 70 years), 29 (15.2%) being women and 162 men (84.8%). Study groups had similar baseline characteristics. Complete procedural success was achieved in 189 out of 191 patients (99.0%), with no significant difference observed between the two groups (p = .17). No major complications were reported in the total cohort. However, there was a significantly higher incidence of minor complications in women compared to men (17.2% vs. 2.5%, p < .01). Following a median follow-up of 6.5 years, the incidence of the primary composite outcome occurred similarly between the study groups (log-rank p = .68)., Conclusion: Women who underwent TLE exhibited a significantly higher incidence of minor acute intra- and peri-procedural complications than men. However, no differences in long-term outcomes between genders were observed., (© 2024 The Author(s). Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.)

Background: Advances in leadless pacemaker technology have enabled accelerometer-based atrioventricular (AV) synchronous pacing by sensing atrial mechanical contraction., Objective: The purpose of this study was to report the performance of the Micra AV leadless pacemaker from the worldwide Micra AV post-approval registry (PAR) through 12 months., Methods: The Micra AV PAR is a prospective, single-arm, observational registry designed to assess the safety and effectiveness of Micra AV in a real-world setting. For the present interim analysis, major complications and system revisions through 12 months were summarized and compared to a historical cohort of 2667 patients implanted with a transvenous dual-chamber pacing system., Results: The device was successfully implanted in 796 of 801 patients (99.4%) at 97 centers in 19 countries. Micra AV patients were older (74.1 years vs 71.1 years; P < .0001) with a higher incidence of renal disease (22.3% vs 9.8%; P < .0001) compared with transvenous dual-chamber patients. Through 12 months, the major complication rate was 3.7% in Micra AV patients compared with 8.8% in transvenous dual-chamber patients (hazard ratio 0.42; 95% confidence interval 0.28-0.61; P < .001). The system revision rate was 1.5% in Micra AV patients compared with 5.5% for transvenous dual-chamber patients (hazard ratio 0.25; 95% confidence interval 0.13-0.47; P < .001); this reduction was largely driven by the absence of lead dislodgments requiring revision. The median AV synchrony index was 79.4% (interquartile range 65.2%-86.4%) in patients paced >90%., Conclusion: The Micra AV leadless pacemaker was implanted with a high rate of success in patients with multiple comorbidities, with a significantly lower rate of complications and system revisions through 12 months compared to a historical cohort of patients with transvenous dual-chamber pacemakers., Competing Interests: Disclosures Dr Garweg has received consultant/speaker fees and research grants from Abbott, Biotronik, and Medtronic. Dr Chinitz has received consulting fees from Medtronic, Boston Scientific, and Biosense Webster and speaking/teaching honorarium fees from Boston Scientific and Biotronik. Dr Marijon has received consulting fees from Medtronic, Abbott, and Boston Scientific. Dr Haeberlin has received travel fees/educational grants from Medtronic, Biotronik, Abbott, and Philips/Spectranetics without impact on personal remuneration and works as a proctor for Medtronic. Dr El-Chami serves as a consultant for Medtronic, Boston Scientific, and Biotronik. Dr Roberts has received honoraria from Medtronic, Boston Scientific, and Abbott and research funding from Boston Scientific. Dr Piccini has received clinical research grants from Abbott and Philips and serves as a consultant for Abbott, Boston Scientific, Medtronic, and Philips. Drs Stromberg and Fagan are employees/shareholders of Medtronic. Dr Clementy has received consulting fees from Medtronic. The remaining authors have nothing to disclose., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: No data regarding subcutaneous-implantable cardioverter defibrillator (S-ICD) technology in patients actively engaging in sports activities are available., Objective: This study aims to compare S-ICD performance between athletes and nonathletes., Methods: The primary outcome of the study was the comparison of overall device-related complications between athletes and nonathletes. Appropriate shocks, inappropriate shocks, and individual device-related complications were secondary outcomes., Results: A total of 1493 patients were extracted from the International Subcutaneous Implantable Cardioverter Defibrillator Registry (iSUSI) registry, of whom 152 (10.2%) were athletes, mostly engaging in dynamic sports (54.2%). Brugada syndrome, myocarditis, and arrhythmogenic right ventricular cardiomyopathy (ARVC) were more common in athletes (11.2% vs 3.3%, P < .001; 19.1% vs 9.0%, P < .001; 8.6% vs 2.8%, P < .001, respectively). During a median follow-up time of 25.5 (12.0-41.2) months, athletes were more likely to experience appropriate shocks (yearly rate: 7.2 [4.9-10.7] % vs 4.3 [3.6-5.1] %, P = .028), occurring more frequently during exercise (3.9% vs 0.6%, P < .001). This finding lost significance when adjusting for confounders (adjusted hazard ratio [aHR] 1.440 [0.909-2.281], P = .120). No differences were found in overall device-related complications (yearly rate: 3.3% vs 3.4%, P = .448) and inappropriate shocks (yearly rate: 5.3% vs 3.7%, P = 0.111). Myopotential oversensing (4.0% vs 1.3%, P = .011) was more common in athletes, as were lead infections (3.3% vs 0.9%, P =.008), with the latter clustering in the early postimplantation period., Conclusion: The S-ICD is a valid therapeutic option for preventing sudden cardiac death in athletes. Sports practice was not associated with an increased risk of complications or inappropriate shocks, although athletes are exposed to a higher risk of S-ICD infections in the early postoperative period., Competing Interests: Disclosures Dr Breitenstein has received consultant/speaker fees from Boston Scientific. Dr Martinek has received speaker`s honoraria from Boston Scientific. Dr Kaiser has received proctor fees from Boston Scientific. Dr Tilz consults for and has received speaker`s honoraria from Boston Scientific. Dr Tondo is a member of Boston Scientific advisory board. The other authors have no conflicts of interest to disclose., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

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 CHA 2 DS 2 -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 CHA 2 DS 2 -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., Competing Interests: Disclosures Mauro Biffi has held educational activity and participated in speaker’s bureau on behalf of Boston Scientific, Biotronik, and Medtronic. Matteo Ziacchi has held educational activity and participated in speaker’s bureau on behalf of Medtronic. Daniele Giacopelli and Alessio Gargaro are employees of Biotronik Italia S.p.a. The remaining authors have no major conflicts of interest to disclose., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

We present the first worldwide case of a hybrid surgical-percutaneous procedure involving transvenous lead extraction, concomitant tricuspid valve repair, implantation of an atrioventricular (AV) leadless pacemaker, and extravascular implantable cardioverter-defibrillator placement with suturing of the defibrillation lead to the heart wall. Multiple interventions were necessary as a result of active endocarditis, congenital complete AV block, and ventricular arrhythmia secondary prevention., Competing Interests: This work was supported by the Italian Ministry of Health-Ricerca Corrente to Centro Cardiologico Monzino IRCCS. Dr Tondo has served on the advisory boards of Medtronic and Boston Scientific; and has received lecture and grant travel fees from Medtronic, Abbott Medical, Boston Scientific, and Atricure. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)

Background: Limited data are available on leadless pacemaker (LPM) outcomes according to different stages of chronic kidney disease (CKD)., Objective: The purpose of this study was to investigate differences in the safety and efficacy of LPMs among patients stratified per different stages of renal function., Methods: Consecutive patients enrolled in the multicenter international i-LEAPER registry (International LEAdless PacemakEr Registry) were analyzed. Patients were divided into 3 groups according to CKD stage. The primary end point was the comparison of LPM-related major complication rate at implantation and during follow-up. Differences in electrical performance were deemed secondary outcomes., Results: Of the 1748 patients enrolled, 33% were in CKD stage G3a/G3b and 9.4% were in CKD stage G4/G5. Patients with CKD presented cardiovascular comorbidities more frequently. During a median follow-up of 39 months (interquartile range [IQR] 18-59 months), major complication rate did not differ between groups (normal kidney function [NKF] group 1.8% vs CKD stage G3a/G3b group 2.9% vs CKD stage G4/G5 group 2.4%; P = .418). All-cause mortality resulted higher in the CKD stage G4/G5 group than in the NKF group (19.5% vs 9.8%; adjusted hazard ratio 1.9; 95% confidence interval 1.25-2.89; P = .003). LPM electrical performance was comparable between groups, except for patients with CKD who showed a slightly higher pacing threshold during 1-month follow-up (NKF group 0.50 V [IQR 0.35-0.70 V] vs G3a/G3b group 0.56 V [IQR 0.38-0.81 V] vs G4/G5 group 0.51 V [0.38-0.84 V] @ 0.24 ms; P < .001)., Conclusion: In a real-world setting, patients with advanced CKD who underwent LPM implantation were underrepresented. Although all-cause mortality was higher in end-stage CKD, periprocedural complications and LPM performance were overall comparable between NKF and different stages of CKD, except for higher values of pacing threshold in patients with CKD up to first-month follow-up., Competing Interests: Disclosures Dr Tondo is a member of an advisory board of Medtronic. Other authors do not report disclosures regarding this article., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Aims: Women have been historically underrepresented in implantable cardioverter-defibrillator (ICD) trials. No data on sex differences regarding subcutaneous ICDs (S-ICD) carriers have been described. Aim of our study was to investigate sex-related differences among unselected S-ICD recipients., Methods and Results: Consecutive patients enrolled in the multicentre, international i-SUSI registry were analysed. Comparisons between sexes were performed using a 1:1 propensity matching adjusted analysis for age, body mass index (BMI), left ventricular function, and substrate. The primary outcome was the rate of appropriate shocks during follow-up. Inappropriate shocks and other device-related complications were deemed secondary outcomes. A total of 1698 patients were extracted from the i-SUSI registry; 399 (23.5%) were females. After propensity matching, two cohorts of 374 patients presenting similar baseline characteristics were analysed. Despite similar periprocedural characteristics and a matched BMI, women resulted at lower risk of conversion failure as per PRAETORIAN score (73.4% vs. 81.3%, P = 0.049). Over a median follow-up time of 26.5 [12.7-42.5] months, appropriate shocks were more common in the male cohort (rate/year 3.4% vs. 1.7%; log-rank P = 0.049), while no significant differences in device-related complications (rate/year: 6.3% vs. 5.8%; log-rank P = 0.595) and inappropriate shocks (rate/year: 4.3% vs. 3.1%; log-rank P = 0.375) were observed. After controlling for confounders, sex remained significantly associated with the primary outcome (aHR 1.648; CI 0.999-2.655, P = 0.048), while not resulting predictor of inappropriate shocks and device-related complications., Conclusion: In a propensity-matched cohort of S-ICD recipients, women are less likely to experience appropriate ICD therapy, while not showing higher risk of device-related complications., Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT0473876., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Outcome comparisons among subcutaneous implantable cardioverter-defibrillator (S-ICD) recipients with nonischemic cardiomyopathies are scarce., Objective: The aim of this study was to evaluate differences in device-related outcomes among S-ICD recipients with different structural substrates., Methods: Patients enrolled in the i-SUSI (International SUbcutaneouS Implantable cardioverter defibrillator registry) project were grouped according to the underlying substrate (ischemic vs nonischemic) and subgrouped into dilated cardiomyopathy, hypertrophic cardiomyopathy, Brugada syndrome (BrS), arrhythmogenic right ventricular cardiomyopathy (ARVC). The main outcome of our study was to compare the rates of appropriate and inappropriate shocks and device-related complications., Results: Among 1698 patients, the most common underlying substrate was ischemic (31.7%), followed by dilated cardiomyopathy (20.5%), BrS (10.8%), hypertrophic cardiomyopathy (8.5%), and ARVC (4.4%). S-ICD for primary prevention was more common in the nonischemic cohort (70.9% vs 65.4%; P = .037). Over a median (interquartile range) follow-up of 26.5 (12.6-42.8) months, no differences were observed in appropriate shocks between ischemic and nonischemic patients (4.8%/y vs 3.9%/y; log-rank, P = .282). ARVC (9.0%/y; hazard ratio [HR] 2.492; P = .001) and BrS (1.8%/y; HR 0.396; P = .008) constituted the groups with the highest and lowest rates of appropriate shocks, respectively. Device-related complications did not differ between groups (ischemic: 6.4%/y vs nonischemic: 6.1%/y; log-rank, P = .666), nor among underlying substrates (log-rank, P = .089). Nonischemic patients experienced higher rates of inappropriate shocks than did ischemic S-ICD recipients (4.4%/y vs 3.0%/y; log-rank, P = .043), with patients with ARVC (9.9%/y; P = .001) having the highest risk, even after controlling for confounders (adjusted HR 2.243; confidence interval 1.338-4.267; P = .002)., Conclusion: Most S-ICD recipients were primary prevention nonischemic cardiomyopathy patients. Among those, patients with ARVC tend to receive the most frequent appropriate and inappropriate shocks and patients with BrS the least frequent appropriate shocks., Competing Interests: Disclosures Dr Gasperetti has received consultant and speaker fees from Boston Scientific. Dr Martinek received speaker’s honoraria from Boston Scientific. Dr Kaiser worked as a proctor for Boston Scientific. Dr Tilz is a consultant for Boston Scientific and received speaker’s honoraria from Boston Scientific. Dr Tondo is a member of Boston Scientific Advisory Board. The other authors do not report disclosures regarding this article., (Copyright © 2023 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Atrial fibrillation (AF) is a common heart rhythm disorder that is associated with an increased risk of stroke and heart failure (HF). Initially, an association between AF and ion channel dysfunction was identified, classifying the pathology as a predominantly electrical disease. More recently it has been recognized that fibrosis and structural atrial remodeling play a driving role in the development of this arrhythmia also in these cases., Purpose: Understanding the role of fibrosis in genetic determined AF could be important to better comprise the pathophysiology of this arrhythmia and to refine its management also in nongenetic forms. In this review we analyze genetic and epigenetic mechanisms responsible for AF and their link with atrial fibrosis, then we will consider analogies with the pathophysiological mechanism in nongenetic AF, and discuss consequent therapeutic options., (© 2024 Wiley Periodicals LLC.)

Background: This study aimed to investigate the characteristics and outcomes of patients diagnosed with Brugada syndrome (BrS) who underwent implantable loop recorder (ILR) insertion during routine clinical activity., Methods: We conducted a comprehensive screening of all consecutive patients diagnosed with BrS at our institution. We analyzed baseline clinical characteristics, arrhythmic findings, and outcomes., Results: Out of 147 BrS patients, 42 (29 %) received an ILR, 13 (9 %) underwent implantable cardioverter-defibrillator (ICD) placement, and 92 patients (63 %) continued regular cardiological follow-up. Patients who received an ILR had a higher prevalence of suspected arrhythmic syncope (43 % vs. 22 %, p = 0.012) and tended to be younger (median age 38 years, interquartile range 30-52, vs. 43 years, 35-55, p = 0.044) with a higher presence of SCN5A gene mutations (17 % vs. 6 %, p = 0.066) compared to those who continued regular follow-up. Additionally, compared to patients with an ICD, those with an ILR had a significantly lower frequency of positive programmed ventricular stimulation (0 % vs. 91 %, p < 0.001). During a median follow-up period of 14.7 months (4.7-44.8), no deaths occurred among the patients with ILR. Eight individuals (19 %) were diagnosed with arrhythmic findings through continuous ILR monitoring, primarily atrial fibrillation, and asystolic pauses. The median time from insertion to the occurrence of these events was 8.7 months (3.6-46.4). No adverse events related to ILR were reported., Conclusion: Continuous monitoring with ILR may facilitate the timely detection of non-malignant rhythm disorders in BrS patients with risk factors but without an indication for primary prevention ICD implantation., Competing Interests: D.G. is employee of Biotronik Italia. The remaining authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 Published by Elsevier B.V.)

Background: Antiarrhythmic drugs and transcatheter ablation in atrial fibrillation (AF) provide suboptimal rhythm control with a not negligible rate of failure in paroxysmal AF (PAF) and nonparoxysmal AF (n-PAF) at midterm and long-term follow-up. This study evaluated the safety profile and long-term efficacy of thoracoscopic ablation in patients with lone AF., Methods: A consecutive 153 patients with lone AF were prospectively enrolled and underwent thoracoscopic surgical ablation. Inclusion criteria were symptomatic AF refractory to pharmacologic therapy (Vaughan-Williams class I-III), age >18 years, and absence of left atrial thrombosis. Exclusion criteria were long-standing AF >5 years, left atrial diameter >55 mm, and contraindication to oral anticoagulation. The "box lesion set" (encircling of pulmonary veins) was always used. Exclusion of the left atrial appendage was performed only in selected cases. The primary study end point was freedom from AF. Secondary end points were overall survival and cumulative incidence function of cardiac event-related death, cerebrovascular accidents, and pacemaker implantation., Results: There was no in-hospital mortality. Early postoperative complications were pacemaker implantation (4/153 [2.6%]), cerebrovascular accident (2/153 [1.3%]) with full recovery of both, and bleeding requiring surgical revision (2/153 [1.3%]). Overall freedom from AF at 7 years was 86% ± 4% (76.9% in n-PAF, 96.1% in PAF). Survival freedom from AF in patients without antiarrhythmic drugs in PAF and n-PAF groups was 79.1% and 52.2%, respectively., Conclusions: Thoracoscopic surgical ablation of lone AF by means of an isolated left atrial box lesion provided an excellent long-term rhythm outcome, even in long-standing persistent AF. The isolated left atrial ablation showed an excellent safety profile with low incidence of pacemaker implantation and postoperative complications., (Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: A complex transvenous lead extraction (TLE) procedure could be associated with lower success and higher complication rates in inexperienced hands. In this study, we aim to assess the factors that determine procedural difficulty in TLE., Methods: We retrospectively studied 200 consecutive patients undergoing TLE in a single referral centre from June 2020 to December 2021. Lead extraction difficulty was assessed by the success of simple manual traction with or without a locking stylet, the need for advanced extraction tools and the number of tools required to extract the lead. Logistic and linear regression analyses were used to determine the factors independently affecting these 3 parameters., Results: 363 leads were extracted from 200 patients (79% males, mean age 66.85 years). The indication for TLE was device-related infection in 51.5%. Multivariate analysis revealed the lead indwelling time to be the only factor affecting the 3 parameters of difficulty. Passive fixation leads and dual coil leads increased procedural difficulty by affecting 2 parameters each. Factors that affected one parameter included infected leads, coronary sinus leads, older age of the patient and a history of valvular heart disease, all associated with a simpler procedure. Right ventricular leads were associated with a more complex one., Conclusion: The most important factor that increased TLE procedural difficulty was a longer lead indwelling time, followed by passive fixation and dual-coil leads. Other contributing factors were the presence of infection, coronary sinus leads, older patients, a history of valvular heart disease and right ventricular leads.

Background: The impact of sex in clinical and procedural outcomes in leadless pacemaker (LPM) patients has not yet been investigated., Objective: The purpose of this study was to investigate sex-related differences in patients undergoing LPM implantation., Methods: Consecutive patients enrolled in the i-LEAPER registry were analyzed. Comparisons between sexes were performed within the overall cohort using an adjusted analysis with 1:1 propensity matching for age and comorbidities. The primary outcome was the comparison of major complication rates. Sex-related differences regarding electrical performance and all-cause mortality during follow-up were deemed secondary outcomes., Results: In the overall population (n = 1179 patients; median age 80 years), 64.3% were men. After propensity matching, 738 patients with no significant baseline differences among groups were identified. During median follow-up of 25 [interquartile range 24-39] months, female sex was not associated with LPM-related major complications (hazard ratio [HR] 2.03; 95% confidence interval [CI] 0.70-5.84; P = .190) or all-cause mortality (HR 0.98; 95% CI 0.40-2.42; P = .960). LPM electrical performance results were comparable between groups, except for a higher pacing impedance in women at implant and during follow-up (24 months: 670 [550-800] Ω vs 616 [530-770] Ω; P = .014) that remained within normal limits., Conclusion: In a real-world setting, we found differences in sex-related referral patterns for LPM implantation with an underrepresentation of women, although major complication rate and LPM performance were comparable between sexes. Female patients showed higher impedance values, which had no impact on overall device performance. Electrical parameters remained within normal limits in both groups during the entire follow-up., (Copyright © 2023 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Introduction: Permanent His bundle pacing (HBP) is the most physiological pacing modality, and new implantation systems are now available. The aim of the present study was to describe and compare four different techniques to perform HBP., Methods and Results: We included all consecutive patients who underwent a HBP attempt in our initial experience between June 2020 and May 2022. The success and characteristics of the procedure were compared among four implantation techniques: the Biotronik Selectra 3D sheath with Solia S60 lead (Selectra 3D), the Boston Scientific Site Selective Pacing Catheter with Ingevity lead (SSPC), the Abbott steerable stylet locator with Tendril lead (Locator), and the use of a standard stylet manually pre-shaped with a conventional pacing lead (Curved stylet). Ninety-eight patients (median age 79 years [interquartile range, 73-83], 83% men) were identified. The Selectra 3D technique was used in 43 procedures, SSPC in 26, Locator in 18 and Curved stylet in 11. The groups had similar clinical characteristics. Overall, procedural success was achieved in 91 patients (93%) with similar proportions among groups (p = .986). Fluoroscopy and procedural times were 6.0 (4.4-8.5) and 60 (45-75) min, respectively, without significant differences (p = .333 and p = .790). The rate of selective capture, the pacing threshold, and the paced QRS duration were also comparable. There was one pre-discharge HBP lead dislodgment (1%) that required implant revision., Conclusion: In our experience, four techniques for HBP achieved comparable results in terms of safety and effectiveness. The availability of different systems may lead to widespread use of physiological pacing., (© 2023 Wiley Periodicals LLC.)

The number of cardiac implantable electronic device (CIED) implantations has increased over recent years as a result of population growth, increasing life expectancy, adoption of guidelines, and better access to healthcare. Device-related infection is, however, one of the most serious complications of CIED therapy associated with significant morbidity, mortality, and financial healthcare burden. Although many preventive strategies such as administration of intravenous antibiotic therapy before implantation are well recognized, uncertainties still exist about other regimens. 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. The key aspect to successful treatment of definite CIED infections is complete removal of all parts of the system and transvenous hardware, including the device and all leads. Thus, transvenous lead extraction has been increasing. Expert consensus statements on how to prevent, diagnose, and treat CIED infections and on lead extraction have been published by the European Heart Rhythm Association in 2020 and 2018, respectively. The aim of this AIAC position paper is to describe the current knowledge on the risks for device-related infections and to assist healthcare professionals in their clinical decision making regarding its prevention, diagnosis, and management by providing the latest update of the most effective strategies.

Background: Transvenous lead extraction (TLE) has shown a safe and efficacy profile in the intraoperative and short-term setting; however, data on long-term outcomes are limited., Objective: The purpose of this study was to assess long-term outcomes and prognostic factors in patients who underwent TLE., Methods: Consecutive patients with cardiac implantable electronic device (CIED) who underwent TLE between 2014 and 2016 were retrospectively studied. The primary outcome was the composite endpoint of death and repeated TLE stratified by infective/non-infective indication. Individual components of the primary outcome were also evaluated., Results: One hundred ninety-one patients were included in the analysis, 50% extracted for CIED-related infection. Complete procedural success was achieved in 189 patients (99%) with no major acute complications. After a median of 6.5 years, infection indication was associated with significantly lower event-free survival (67% vs. 83% non-infection group, adjusted hazard ratio [aHR] 1.97, 95% confidence interval [CI] 1.02-3.81, p = 0.04). All-cause mortality rate was higher in the TLE infection group (30% vs. 10%, p < 0.01). The rate of repeated TLE did not differ between groups (4% vs. 7%, p = 0.62). Among patients who had TLE for infection, the presence of vegetation (aHR 2.56; 95%CI 1.17-5.63, p = 0.02) and positive blood cultures (aHR 2.64; 95%CI 1.04-6.70, p = 0.04) were independently associated with the primary outcome., Conclusion: Patients who underwent TLE for CIED-related infection exhibit a high mortality risk during long-term follow-up. Vegetation and positive blood cultures in patients with CIED-related infection are associated with a worse prognosis regardless of successful and uncomplicated TLE., Competing Interests: Declaration of Competing Interest D.G. is employee of BIOTRONIK Italia. All the remaining authors have no conflicts of interest to disclose., (Copyright © 2023 Elsevier B.V. All rights reserved.)

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., (© 2023 Wiley Periodicals LLC.)

Background: Infections of cardiovascular implantable electronic devices (CIED) are mainly due to Gram-positive bacteria (GPB). Data about Gram-negative bacteria CIED (GNB-CIED) infections are limited. This study aimed to investigate risk factors, clinical and diagnostic characteristics, and outcome of patients with GNB-CIED., Methods: A multicentre, international, retrospective, case-control-control study was performed on patients undergoing CIED implantation from 2015 to 2019 in 17 centres across Europe. For each patient diagnosed with GNB-CIED, one matching control with GPB-CIED infection and two matching controls without infection were selected., Results: A total of 236 patients were enrolled: 59 with GNB-CIED infection, 59 with GPB-CIED infection and 118 without infection. No between-group differences were found regarding clinical presentation, diagnostic and therapeutic management. A trend toward a higher rate of fluorodeoxyglucose positron emission computed tomography (FDG PET/CT) positivity was observed among patients with GNB than in those with GPB-CIED infection (85.7% vs. 66.7%; P = 0.208). Risk factors for GNB-CIED infection were Charlson Comorbidity Index Score (relative risk reduction, RRR = 1.211; P = 0.011), obesity (RRR = 5.122; P = 0.008), ventricular-pacing ventricular-sensing inhibited-response pacemaker implantation (RRR = 3.027; P = 0.006) and right subclavian vein site of implantation (RRR = 5.014; P = 0.004). At 180-day survival analysis, GNB-CIED infection was associated with increased mortality risk (HR = 1.842; P = 0.067)., Conclusions: Obesity, high number of comorbidities and right subclavian vein implantation site were associated with increased risk of GNB-CIED infection. A prompt therapeutic intervention that may be guided using FDG PET/CT is suggested in patients with GNB-CIED infection, considering the poorer outcome observed in this group., Competing Interests: Competing Interests All the authors report no conflicts of interest., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Limited data on the real-world safety and efficacy of leadless pacemakers (LPMs) post-transvenous lead extraction (TLE) are available., Objective: The purpose of this study was to assess the long-term safety and effectiveness of LPMs following TLE in comparison with LPMs de novo implantation., Methods: Consecutive patients who underwent LPM implantation in 12 European centers joining the International LEAdless PacemakEr Registry were enrolled. The primary end point was the comparison of LPM-related complication rate at implantation and during follow-up (FU) between groups. Differences in electrical performance were deemed secondary outcomes., Results: Of the 1179 patients enrolled, 15.6% underwent a previous TLE. During a median FU of 33 (interquartile range 24-47) months, LPM-related major complications and all-cause mortality did not differ between groups (TLE group: 1.6% and 5.4% vs de novo group: 2.2% and 7.8%; P = .785 and P = .288, respectively). Pacing threshold (PT) was higher in the TLE group at implantation and during FU, with very high PT (>2 V@0.24 ms) patients being more represented than in the de novo implantation group (5.4% vs 1.6 %; P = .004). When the LPM was deployed at a different right ventricular (RV) location than the one where the previous transvenous RV lead was extracted, a lower proportion of high PT (>1-2 V@0.24 ms) patients at implantation, 1-month FU, and 12-month FU (5.9% vs 18.2%, P = .012; 3.4% vs 12.9%, P = .026; and 4.3% vs 14.5%, P = .037, respectively) was found., Conclusion: LPMs showed a satisfactory safety and efficacy profile after TLE. Better electrical parameters were obtained when LPMs were implanted at a different RV location than the one where the previous transvenous RV lead was extracted., (Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Age-related differences on leadless pacemaker (LP) are poorly described. Aim of this study was to compare clinical indications, periprocedural and mid-term device-associated outcomes in a large real-world cohort of LP patients, stratified by age at implantation., Methods: Two cohorts of younger and older patients (≤50 and > 50 years old) were retrieved from the iLEAPER registry. The primary outcome was to compare the underlying indication why a LP was preferred over a transvenous PM across the two cohorts. Rates of peri-procedural and mid-term follow-up major complications as well as LP electrical performance were deemed secondary outcomes., Results: 1154 patients were enrolled, with younger patients representing 6.2% of the entire cohort. Infective and vascular concerns were the most frequent characteristics that led to a LP implantation in the older cohort (45.8% vs 67.7%, p < 0.001; 4.2% vs 16.4%, p = 0.006), while patient preference was the leading cause to choose a LP in the younger (47.2% vs 5.6%, p < 0.001). Median overall procedural (52 [40-70] vs 50 [40-65] mins) and fluoroscopy time were similar in both groups. 4.3% of patients experienced periprocedural complications, without differences among groups. Threshold values were higher in the younger, both at discharge and at last follow-up (0.63 [0.5-0.9] vs 0.5 [0.38-0-7] V, p = 0.004)., Conclusion: When considering LP indications, patient preference was more common in younger, while infective and vascular concerns were more frequent in the older cohort. Rates of device-related complications did not differ significantly. Younger patients tended to have a slightly higher pacing threshold at mid-term follow-up., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background. Data on leadless pacemaker (LPM) implantation in an emergency setting are currently lacking. Objective. We aimed to investigate the feasibility of LPM implantation for emergency bradyarrhythmia, in patients referred for urgent PM implantation, in a large, multicenter, real-world cohort of LPM recipients. Methods. Two cohorts of LPM patients, stratified according to the LPM implantation scenario (patients admitted from the emergency department (ED+) vs. elective patients (ED−)) were retrieved from the iLEAPER registry. The primary outcome of the study was a comparison of the peri-procedural complications between the groups. The rates of peri-procedural characteristics (overall procedural and fluoroscopic duration) were deemed secondary outcomes. Results. A total of 1154 patients were enrolled in this project, with patients implanted due to an urgent bradyarrhythmia (ED+) representing 6.2% of the entire cohort. Slow atrial fibrillation and complete + advanced atrioventricular blocks were more frequent in the ED+ cohort (76.3% for ED+ vs. 49.7% for ED−, p = 0.025; 37.5% vs. 27.3%, p = 0.027, respectively). The overall procedural times were longer in the ED+ cohort (60 (45−80) mins vs. 50 (40−65) mins, p < 0.001), showing higher rates of temporary pacing (94.4% for ED+ vs. 28.9% for ED−, p < 0.001). Emergency LPM implantation was not correlated with an increase in the rate of major complications compared to the control group (6.9% ED+ vs. 4.2% ED−, p = 0.244). Conclusion. LPM implantation is a feasible procedure for the treatment of severe bradyarrhythmia in an urgent setting. Urgent LPM implantation was not correlated with an increase in the rate of major complications compared to the control group, but it was associated with longer procedural times.

Background: The absence of pacing capabilities may reduce the appeal of subcutaneous implantable cardioverter-defibrillator (S-ICD) devices for patients at risk for conduction disorders or with antitachycardia pacing (ATP)/cardiac resynchronization (CRT) requirements. Reports of rates of S-ICD to transvenous implantable cardioverter-defibrillator (TV-ICD) system switch in real-world scenarios are limited., Objective: The purpose of this study was to investigate the need for a subsequent transvenous (TV) device in patients implanted with an S-ICD and its predictors., Methods: All patients implanted with an S-ICD were enrolled from the multicenter, real-world iSUSI (International SUbcutaneouS Implantable cardioverter defibrillator) Registry. The need for a TV device and its clinical reason, and appropriate and inappropriate device therapies were assessed. Logistic regression with Firth penalization was used to assess the association between baseline and procedural characteristics and the overall need for a subsequent TV device., Results: A total of 1509 patients were enrolled (age 50.8 ± 15.8 years; 76.9% male; 32.0% ischemic; left ventricular ejection fraction 38% [30%-60%]). Over 26.5 [13.4-42.9] months, 155 (10.3%) and 144 (9.3%) patients experienced appropriate and inappropriate device therapies, respectively. Forty-one patients (2.7%) required a TV device (13 bradycardia; 10 need for CRT; 10 inappropriate shocks). Body mass index (BMI) >30 kg/m 2 and chronic kidney disease (CKD) were associated with need for a TV device (odds ratio [OR] 2.57 [1.37-4.81], P = .003; and OR 2.67 [1.29-5.54], P = .008, respectively)., Conclusion: A low rate (2.7%) of conversion from S-ICD to a TV device was observed at follow-up, with need for antibradycardia pacing, ATP, or CRT being the main reasons. BMI >30 kg/m 2 and CKD predicted all-cause need for a TV device., (Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Causes of sex differences in incidence of sustained ventricular arrhythmias (SVAs) are poorly understood., Objectives: This study aims to investigate sex-specific risk of SVAs and device therapies by balancing sex groups in relation to several baseline characteristics with the propensity score (PS)., Methods: We used a large remote monitoring dataset from implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). Study endpoints were time to the first appropriate SVA, time to the first device therapy for SVA, and time to the first ICD shock. Results were compared between females and a PS-matched male subgroup., Results: In a cohort of 2,532 patients with an ICD or CRT-D (median age, 70 years), 488 patients (19.3%) were women. After selecting 488 men PS-matched for 19 variables relative to baseline demographics, implant indications, principal comorbidities, and concomitant therapy, yet the SVA rate at the 2.1-year median follow-up was significantly lower in women than in man (adjusted HR: 0.65; 95% CI: 0.51-0.81; P < 0.001). Women also showed a reduced risk of any device therapy (HR: 0.59; 95% CI: 0.45-0.76; P < 0.001) and shocks (HR: 0.66; 95% CI: 0.47-0.94; P = 0.021). Differences in sex-specific SVA risk profile were not confirmed in CRT-D patients (HR: 0.78; 95% CI: 0.55-1.09; P = 0.14) nor in those with an ejection fraction <30% (HR: 0.80; 95% CI: 0.52-1.23; P = 0.31)., Conclusions: After matching demographics, indications, principal comorbidities, and concomitant therapy, women still exhibited a lower SVA risk profile than men, except in the subgroups of CRT-D or/and ejection fraction <30%., Competing Interests: Funding Support and Author Disclosures Manuscript editing was partially supported by BIOTRONIK Italia S.p.A. (V.le delle Industrie 11, 20055, Vimodrone [MI], Italy), which also provided assistance in statistical analysis but had no role in data collection and interpretation. Mr Giacopelli and Mr Gargaro are employees of BIOTRONIK Italia. All other authors have reported that they have relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction: The prevalence and impact of pulmonary embolism (PE) in patients with lead-related infective endocarditis undergoing transvenous lead extraction (TLE) are unknown., Methods: Twenty-five consecutive patients with vegetations ≥10 mm at transoesophageal echocardiography were prospectively studied. Contrast-enhanced chest computed tomography (CT) was performed before (pre-TLE) and after (post-TLE) the lead extraction procedure., Results: Pre-TLE CT identified 18 patients (72%) with subclinical PE. The size of vegetations in patients with PE did not differ significantly from those without (median 20.0 mm [interquartile range: 13.0-30.0] vs. 14.0 mm [6.0-18.0], p = 0.116). Complete TLE success was achieved in all patients with 3 (2-3) leads extracted per procedure. There were no postprocedure complications related to the presence of PE and no differences in terms of fluoroscopy time and need for advanced tools. In the group of positive pre-TLE CT, post-TLE scan confirmed the presence of silent PE in 14 patients (78%). There were no patients with new PE formation. Large vegetations (≥20 mm) tended to increase the risk of post-TLE subclinical PE (odds ratio 5.99 [95% confidence interval (CI): 0.93-38.6], p = 0.059). During a median 19.4 months follow-up, no re-infection of the implanted system was reported. Survival rates in patients with and without post-TLE PE were similar (hazard ratio: 1.11 [95% CI: 0.18-6.67], p = 0.909)., Conclusion: Subclinical PE detected by CT was common in patients undergoing TLE with lead-related infective endocarditis and vegetations but was not associated with the complexity of the procedure or adverse outcomes. TLE procedure seems safe and feasible even in patients with large vegetations., (© 2022 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.)

Background: Atrioventricular node ablation (AVNA) and pacemaker (PM) is performed in symptomatic atrial fibrillation (AF) unresponsive to medical treatment and percutaneous ablation. This meta-analysis evaluated results after AVNA and PM., Methods: Primary and secondary endpoints were early/late overall/cardiac-related mortality and early/late postoperative complications. Meta-regression explored mortality and preoperative characteristics relation., Results: We selected 93 studies with 11,340 patients: 9105 right ventricular (RV)-PM, and 2235 biventricular PM (cardiac resynchronization therapy, CRT). Malignant arrhythmia (2.5%), heart failure (2.4%), and lead dislodgement (2.0%) were most common periprocedural complications. Pooled estimated 30-day mortality was 1.08% (95%CI:0.65-1.77). At 19.9 months median follow-up (IQR: 10.3-34 months), rehospitalization (0.79%/month) and heart failure (0.48%/month) were the most frequent complications. Overall mortality incidence rate (IR) was 0.43%/month (95%CI:0.36-0.51), and cardiac death IR 0.27%/month (95%CI:0.22-0.32). No mortality determinants emerged in the AVNA CRT subgroup. AVNA RV-PM subgroup univariable meta-regression showed inverse relationship between age, ejection fraction (EF), and late cardiac death (Beta = -0.0709 ± 0.0272; p = 0.0092 and Beta = -0.0833 ± 0.0249; p = 0.0008). Coronary artery disease (CAD) was directly associated to follow-up overall/cardiac mortality at univariable (Beta = 0.0550 ± 0.0136, p < 0.0001; Beta = 0.0540 ± 0.0130, p < 0.0001) and multivariable (Beta = 0.0460 ± 0.0189, p = 0.152; Beta = 0.0378 ± 0.0192, p = 0.0491) meta-regression., Conclusions: Solid long-term evidence supporting AVNA and pace is lacking. Younger patients with reduced LVEF% have increased follow-up cardiac mortality after AVNA RV and may require CRT. Alternative strategies to maintain sinus rhythm and ventricular synchronism should be compared to AVNA to support future treatment strategies., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Purpose: The purpose of this study was to assess the available mortality risk stratification models for implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) patients., Methods: We conducted a review of mortality risk stratification models and tested their ability to improve prediction of 1-year survival after implant in a database of patients who received a remotely controlled ICD/CRT-D device during routine care and included in the independent Home Monitoring Expert Alliance registry., Results: We identified ten predicting models published in peer-reviewed journals between 2000 and 2021 (Parkash, PACE, MADIT, aCCI, CHA2DS2-VASc quartiles, CIDS, FADES, Sjoblom, AAACC, and MADIT-ICD non-arrhythmic mortality score) that could be tested in our database as based on common demographic, clinical, echocardiographic, electrocardiographic, and laboratory variables. Our cohort included 1,911 patients with left ventricular dysfunction (median age 71, 18.3% female) from sites not using any risk stratification score for systematic patient screening. Patients received an ICD (53.8%) or CRT-D (46.2%) between 2011 and 2017, after standard physician evaluation. There were 56 deaths within 1-year post-implant, with an all-cause mortality rate of 2.9% (95% confidence interval [CI], 2.3-3.8%). Four predicting models (Parkash, MADIT, AAACC, and MADIT-ICD non-arrhythmic mortality score) were significantly associated with increased risk of 1-year mortality with hazard ratios ranging from 3.75 (CI, 1.31-10.7) to 6.53 (CI 1.52-28.0, p ≤ 0.014 for all four). Positive predictive values of 1-year mortality were below 25% for all models., Conclusion: In our analysis, the models we tested conferred modest incremental predicting power to ordinary screening methods., (© 2021. Springer Science+Business Media, LLC, part of Springer Nature.)

Superior vena cava (SVC) syndrome is a rare disease induced by thrombosis and consequent occlusion of SVC, negatively affecting morbidity and mortality. The incidence of SVC syndrome from central venous catheters and pacemaker or defibrillator leads is increasing. Optimal treatment of pacemaker or defibrillator-related SVC syndrome is not well defined. Lead extraction causes mechanical trauma to the vessel wall. In addition, subsequent device implantation on the contralateral side can be an added factor for venous occlusion. The use of leadless pacemakers could be an interesting option to reduce the risk of SVC restenosis after lead extraction. We report a clinical case of PM leads-related SVC syndrome referred to our centers and treated with transvenous lead extraction, leadless pacemaker implantation and subsequent percutaneous angioplasty and stenting of the SVC and left innominate vein., (© 2022 Wiley Periodicals LLC.)

Introduction: Predictors of late life-threatening arrhythmic events in Brugada syndrome (BrS) patients who received a prophylactic ICD implantation remain to be evaluated. The aim of the present long-term multicenter study was to assess the incidence and clinical-electrocardiographic predictors of late life-threatening arrhythmic events in BrS patients with a prophylactic implantable cardioverter defibrillator (ICD) and undergoing generator replacement (GR)., Methods: The study population included 105 patients (75% males; mean age 45 ± 14years) who received a prophylactic ICD and had no arrhythmic event up to first GR., Results: The median period from first ICD implantation to last follow-up was 155 (128-181) months and from first ICD Implantation to the GR was 84 (61-102) months. During a median follow-up of 57 (38-102) months after GR, 10 patients (9%) received successful appropriate ICD intervention (1.6%/year). ICD interventions included shock on ventricular fibrillation ( n = 8 patients), shock on ventricular tachycardia ( n = 1 patient), and antitachycardia pacing on ventricular tachycardia ( n = 1 patient). At survival analysis, history of atrial fibrillation (log-rank test; P = 0.02), conduction disturbances (log-rank test; P < 0.01), S wave in lead I (log-rank test; P = 0.01) and first-degree atrioventricular block (log-rank test; P = 0.04) were significantly associated with the occurrence of late appropriate ICD intervention. At Cox-regression multivariate analysis, S-wave in lead I was the only independent predictor of late appropriate ICD intervention (HR: 9.17; 95%CI: 1.15-73.07; P = 0.03)., Conclusions: The present study indicates that BrS patient receiving a prophylactic ICD may experience late appropriate intervention after GR in a clinically relevant proportion of cases. S-wave in lead I at the time of first clinical evaluation was the only independent predictor of persistent risk of life-threatening arrhythmic events. These findings support the need for GR at the end of service regardless of previous appropriate intervention, mostly in BrS patients with conduction abnormalities., Competing Interests: VM received an educational grant from the Enrico and Enrica Sovena Fundation, Italy. G-BC received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Boston Scientific, Acutus Medical. CA receives research grants on behalf of the center from Biotronik, Medtronic, Abbott, LivaNova, Boston Scientific, AtriCure, Philips, Acutus, and received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Livanova, Boston Scientific, Atricure, Acutus Medical, and Daiichi Sankyo. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Migliore, Martini, Calo', Martino, Winnicki, Vio, Condello, Rizzo, Zorzi, Pannone, Miraglia, Sieira, Chierchia, Curcio, Allocca, Mantovan, Salghetti, Curnis, Bertaglia, De Lazzari, de Asmundis and Corrado.)

Background: Transvenous lead extraction is the standard therapy for cardiac device-related infection. In some patients, however, a hybrid surgical and transvenous approach may be necessary., Methods and Results: We present three cases who underwent transvenous lead extraction for an infected CRT-D system. In all cases the CS lead could not be retrieved transvenously due to extensive fibrosis. The lead was successfully extracted through left minithoracotomy in two patients and midline sternotomy in one patient., Conclusion: In cases where the coronary sinus lead shows severe fibrosis, a transvenous approach can be used to free the proximal part of the lead, while the distal adhesions can be removed surgically through a limited thoracic incision., (© 2022 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

Background: A few limited case series have shown that the subcutaneous implantable cardioverter-defibrillator (S-ICD) system is safe for teenagers and young adults, but a large-scale analysis currently is lacking., Objectives: The purpose of this study was to compare mid-term device-associated outcomes in a large real-world cohort of S-ICD patients, stratified by age at implantation., Methods: Two propensity-matched cohorts of teenagers + young adults (≤30 years old) and adults (>30 years old) were retrieved from the ELISIR Registry. The primary outcome was the comparison of inappropriate shock rate. Complications, freedom from sustained ventricular arrhythmias, and overall and cardiovascular mortality were deemed secondary outcomes., Results: Teenagers + young adults represented 11.0% of the entire cohort. Two propensity-matched groups of 161 patients each were used for the analysis. Median follow-up was 23.1 (13.2-40.5) months. In total, 15.2% patients experienced inappropriate shocks, and 9.3% device-related complications were observed, with no age-related differences in inappropriate shocks (16.1% vs 14.3%; P = .642) and complication rates (9.9% vs 8.7%; P = .701). At univariate analysis, young age was not associated with increased rates of inappropriate shocks (hazard ratio [HR] 1.204 [0.675-2.148]: P = .529). At multivariate analysis, use of the SMART Pass algorithm was associated with a strong reduction in inappropriate shocks (adjusted HR 0.292 [0.161-0.525]; P <.001), whereas arrhythmogenic right ventricular cardiomyopathy (ARVC) was associated with higher rates of inappropriate shocks (adjusted HR 2.380 [1.205-4.697]; P = .012)., Conclusion: In a large multicenter registry of propensity-matched patients, use of the S-ICD in teenagers/young adults was safe and effective. The rates of inappropriate shocks and complications between cohorts were not significantly different. The only predictor of increased inappropriate shocks was a diagnosis of ARVC., (Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Introduction: We hypothesized that an accurate assessment of preoperative venography could be useful in predicting transvenous lead extraction (TLE) difficulty., Methods and Results: A dedicated preoperative venogram was performed in consecutive patients with cardiac implantable electronic device who underwent TLE. The level of stenosis was classified as without significant stenosis, moderate, severe, and occlusion. The presence of extensive lead-venous wall adherence (≥50 mm) was also assessed. A total of 105 patients (median age: 71 years; 72% male) with a median of 2 (1-2) leads to extract were enrolled. Preoperative venography showed moderate to severe stenosis in 31 (30%), complete occlusion in 15 (14%), and extensive lead-venous wall adherence in 50 (48%) patients. Complete TLE success was achieved in 103 (98%) patients. A total of 55 (52%) were advanced extractions as they required a powered mechanical and/or laser sheath. They were more prevalent in the group with extensive lead-venous wall adherence (72% vs. 34%, p < .001), while no differences were found between patients with and without venous occlusion. In multivariate analysis, the presence of adherence was a predictor of advanced extraction (odds ratio: 2.89 [1.14-7.32], p = .025). The fluoroscopy time was also significantly longer (14.0 [8.2-18.7] vs. 5.1 [2.1-10.0] min, p < .001). The rate of complications did not differ based on the presence of venous lesions., Conclusion: Although procedural success and complication rates were similar, patients with extensive lead-venous wall adherence required a longer fluoroscopy time and were three times more likely to need advanced extraction tools. Conversely, the presence of total venous occlusion had no impact on the procedure complexity., (© 2022 Wiley Periodicals LLC.)

The aim of this research was to evaluate if patients with chronic kidney disease (CKD) and mild or mild to moderate depression of renal function have an increased risk of atrial fibrillation (AF) recurrences after cryoballoon (CB) ablation. We performed a retrospective analysis of AF patients undergoing pulmonary vein isolation (PVI) by CB. The cohort was divided according to the KDIGO CKD-EPI classification into a (1) normal, (2) mildly decreased, or (3) mild to moderate reduction in estimated glomerular filtration rate (eGFR). Freedom from AF recurrences was the primary endpoint. A total of 1971 patients were included (60 ± 10 years, 29.0% females, 73.6% paroxysmal AF) in the study. Acute success and complication rates were 99.2% and 3.7%, respectively, with no significant differences among the three groups. After a follow-up of 24 months, AF recurrences were higher in the mildly and mild to moderate CKD groups compared to the normal kidney function group (23.4% vs. 28.3% vs. 33.5%, p < 0.05). Mild to moderate CKD was an independent predictor of AF recurrences after the blanking period (hazard ratio:1.38, 95% CI 1.02−1.86, p = 0.037). In conclusion, a multicenter analysis of AF patients treated with cryoablation revealed mild to moderate reductions in renal functions were associated with a higher risk of AF recurrences. Conversely, the procedural success and complication rates were similar in patients with normal, mildly reduced, or mild to moderate reduction in eGFR.

Purpose: High pacing threshold (HPT) and very high pacing threshold (VHPT) are known to have a negative impact on leadless pacemaker battery longevity, representing the most common reason for device repositioning. In this study, we evaluated if intraoperative electrical parameters recorded during Micra™ VR implant would be able to predict device performance during follow-up (FU)., Methods: A total of 93 patients undergoing Micra™ VR implant were retrospectively considered. Patients were enrolled in the study if electrical assessment was performed at least twice at implant, at Micra™ final positioning and after removal of the delivery system. All patients received a FU visit at 1 and 12 month after discharge. R-wave sensing amplitude, pacing threshold (PT), and impedance were recorded at each visit., Results: When compared to the first assessment, R-wave sensing amplitude increased by 19.1% after 13 ± 4 min (+ 1.71 ± 0.2 mV, 95% CI 1.4 to 2.02; p < .001). Conversely, there was a significant PT decrease of 22.1% at 12-month FU (- 0.22 ± 0.03 V, 95% CI - 0.13 to - 0.31; p < .001). Among patients with HPT, acute increase of R-wave sensing of 1.5 mV after 14 ± 4 min predicted a significant reduction of PT below 1 V/0.24, at 12-month post-implant (R = 0.72, 95% CI 0.13 to 0.33, p < .001), with a sensitivity of 87.5% (95% CI 0.61-0.98) and a specificity of 88.8% (95% CI 0.51-0.99)., Conclusion: A 1.5-mV increase in R-wave amplitude at implant is predictive of PT normalization (< 1.0 V/0.24 ms) at 12-month FU. This finding may have practical implications for device repositioning in case of HPT recording at implant., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background and Aim: Thromboembolic events due to left atrial appendage (LAA) thrombosis are the main complication of non-valvular atrial fibrillation (NVAF). Although anticoagulants are effective in patients with NVAF, a minimal residual thromboembolic risk persists. Little is known about the prevalence of LAA thrombus and the rate of resolution after the recommended period of anticoagulation therapy, including vitamin K antagonists (VKA), heparin, and non-vitamin K antagonist oral anticoagulants (NOACs)., Methods and Results: We aimed to study the prevalence of LAA thrombus in an unselected cohort of patients undergoing transesophageal echocardiogram (TEE), and the determinants of LAA thrombus resolution. We retrospectively analyzed 8888 consecutive TEEs performed over five years in two high-volume centers and included all patients with LAA thrombus. A total of 265 patients (3%) had an LAA thrombus. Among these, 97% presented with AF. Fifty-eight percent of patients were on anticoagulants at least three weeks before the diagnosis. After the LAA thrombus diagnosis, VKAs were prescribed in 52%, heparin in 18.5%, and NOAC in 27% of patients. Among the 183 patients with repeat TEE, performed at (25-75th) 39 days (21-84), 67% showed resolution of the LAA thrombus. Although the rate of thrombus resolution was higher in patients treated with NOACs (NOACs 71%, VKA 66%, Heparin 60%) the difference between anticoagulants was statistically non-significant (VKA, OR 0.9, p = 0.83; NOAC, OR 1.23, p = 0.42; heparin, OR 0.69, p = 0.35). Thus, NOACs were demonstrated to be at least as effective as other anticoagulants in the rate of LAA thrombus resolution. Upon multivariate-adjusted analysis, higher LAA emptying velocities were the only predictor of thrombus resolution. In conclusion, the majority of patients were already on anticoagulants. NOACs could be at least as effective as other anticoagulants, yielding an LAA thrombus resolution in two-thirds of patients. This may have clinical relevance, especially in patients undergoing cardioversion or catheter ablation.

Aims: The coronavirus disease-19 (COVID-19) outbreak has been recently associated with lower hospitalization rates for acute coronary syndromes. Aim of the study was to investigate whether a similar behaviour is observed in admissions for urgent pacemaker implant., Methods: This retrospective study included 1315 patients from 18 hospitals in Northern Italy with a high number of COVID-19 cases. Hospitalization rates for urgent pacemaker implant were compared between the following periods: 20 February to 20 April 2020 (case period); from 1 January to 19 February 2020 (intra-year control period); from 20 February to 20 April 2019 (inter-year control period)., Results: The incidence rate of urgent implants was 5.0/day in the case period, 6.0/day in the intra-year control period and 5.8/day in the inter-year control period. Incidence rate in the case period was significantly lower than both the intra-year [incidence rate ratio (IRR): 0.81, 95% CI 0.67-0.99, P = 0.040] and inter-year control periods (IRR: 0.79, 95% CI 0.66-0.95, P = 0.012); this reduction was highest after the national lockdown (IRR 0.68, 95% CI 0.52-0.91, P = 0.009). The prevalence of residents in rural areas undergoing urgent pacemaker implant was lower in the case period (36%) than in both the intra-year (47%, P = 0.03) and inter-year control periods (51%, P = 0.002). Elective pacemaker implants also decreased in the case period, with the incidence rate here being 3.5/day vs. 6.4/day in the intra-year (-45%) and 6.9/day in the inter-year period (-49%)., Conclusion: Despite severe clinical patterns, the COVID-19 outbreak has negatively affected the population presentation to Emergency Departments for bradyarrhythmias requiring urgent pacemaker implant in Northern Italy. This mainly occurred after the national lockdown and concerned patients living in rural areas., (Copyright © 2021 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Background: The real-world efficacy and safety of atrial fibrillation (AF) ablation in particularly young and elderly patients are still under debate. The aim of the analysis was to investigate the effect of age on the efficacy and safety of cryoballoon ablation (CBA)., Methods: 2,534 patients underwent pulmonary vein isolation (PVI) by way of CBA for paroxysmal or persistent drug-resistant and symptomatic AF. The population was divided into age quartiles for evaluation, including (1) <53 years, (2) ≥53 and <61 years, (3) ≥61 and <67 years, and (4) ≥67 years. Furthermore, outcomes were analyzed in patients <41 years, ≥41 and ≤74, and >74 years old. Procedural data and complications were collected, and atrial fibrillation recurrences were evaluated during follow-up., Results: Procedural-related complications (4.1%) were similar in the four subgroups according to age. At the 12-month follow-up, freedom from AF recurrence was 79.2%, 77.4%, 76.8%, and 75.2% ( p =0.21), respectively (with increasing age). At 24-month follow-up, similar incidences of AF recurrence were observed in the four subgroups. When the sample was arbitrarily divided into the three age groups, a higher rate of recurrence was observed in older patients with regard to long-term follow-up (freedom from AF recurrence was 71.8% and 40.9%, respectively, at 12 and 24-month follow-up). In the univariate and multivariate analysis, age did not result in a significant predictor of AF recurrence during follow-up; however, a trend toward higher AF recurrences rates in patients ≥67 years was observed., Conclusion: The data demonstrated a high degree of safety during CBA across all patient ages. Procedural performance and complications were similar between different ages; AF recurrences seem to be more frequent in patients over 74 years., Competing Interests: The authors declare that they have no conflicts of interest., (Copyright © 2021 Luigi Sciarra et al.)

Background: Recently, the Food and Drug Administration issued a recall for the subcutaneous implantable cardioverter-defibrillator (S-ICD) because of the possibility of lead ruptures and accelerated battery depletion., Objective: The aim of this study was to evaluate device-related complications over time in a large real-world multicenter S-ICD cohort., Methods: Patients implanted with an S-ICD from January 2015 to June 2020 were enrolled from a 19-institution European registry (Experience from the Long-term Italian S-ICD registry [ELISIR]; ClinicalTrials.gov identifier NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue., Results: A total of 1254 patients (median age 52.0 [interquartile range 41.0-62.2] years; 973 (77.6%) men; 387 (30.9%) ischemic) was enrolled. Over a follow-up of 23.2 (12.8-37.8) months, complications were observed in 117 patients (9.3%) for a total of 127 device-related complications (23.6% managed conservatively and 76.4% required reintervention). Twenty-seven patients (2.2%) had unanticipated generator replacement after 3.6 (3.3-3.9) years, while 4 (0.3%) had lead rupture. Body mass index (hazard ratio [HR] 1.063 [95% confidence interval 1.028-1.100]; P < .001), chronic kidney disease (HR 1.960 [1.191-3.225]; P = .008), and oral anticoagulation (HR 1.437 [1.010-2.045]; P = .043) were associated with an increase in overall complications, whereas older age (HR 0.980 [0.967-0.994]; P = .007) and procedure performed in high-volume centers (HR 0.463 [0.300-0.715]; P = .001) were protective factors., Conclusion: The overall complication rate over 23.2 months of follow-up in a multicenter S-ICD cohort was 9.3%. Early unanticipated device battery depletions occurred in 2.2% of patients, while lead fracture was observed in 0.3%, which is in line with the expected rates reported by Boston Scientific., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: To date, only a few comparisons between subcutaneous implantable cardioverter-defibrillator (S-ICD) patients undergoing and those not undergoing defibrillation testing (DT) at implantation (DT+ vs DT-) have been reported., Objective: The purpose of this study was to compare long-term clinical outcomes of 2 propensity-matched cohorts of DT+ and DT- patients., Methods: Among consecutive S-ICD patients implanted across 17 centers from January 2015 to October 2020, DT- patients were 1:1 propensity-matched for baseline characteristics with DT+ patients. The primary outcome was a composite of ineffective shocks and cardiovascular mortality. Appropriate and inappropriate shock rates were deemed secondary outcomes., Results: Among 1290 patients, a total of 566 propensity-matched patients (283 DT+; 283 DT-) served as study population. Over median follow-up of 25.3 months, no significant differences in primary outcome event rates were found (10 DT+ vs 14 DT-; P = .404) as well as for ineffective shocks (5 DT- vs 3 DT+; P = .725). At multivariable Cox regression analysis, DT performance was associated with a reduction of neither the primary combined outcome nor ineffective shocks at follow-up. A high PRAETORIAN score was positively associated with both the primary outcome (hazard ratio 3.976; confidence interval 1.339-11.802; P = .013) and ineffective shocks alone at follow-up (hazard ratio 19.030; confidence interval 4.752-76.203; P = .003)., Conclusion: In 2 cohorts of strictly propensity-matched patients, DT performance was not associated with significant differences in cardiovascular mortality and ineffective shocks. The PRAETORIAN score is capable of correctly identifying a large percentage of patients at risk for ineffective shock conversion in both cohorts., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

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%., (© 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Aims: Patients with permanently increased risk of sudden cardiac death (SCD) can be protected by implantable cardioverter defibrillators (ICD). If an ICD must be removed due to infection, for example, immediate reimplantation might not be possible or indicated. The wearable cardioverter defibrillator (WCD) is an established, safe and effective solution to protect patients from SCD during this high-risk bridging period. Very few economic evaluations on WCD use are currently available., Methods: We conducted a systematic review to evaluate the available evidence of WCD in patients undergoing ICD explant/lead extraction. Additionally, a decision model was developed to compare use and costs of the WCD with standard therapy (in-hospital stay). For this purpose, a cost-minimization analysis was conducted, and complemented by a one-way sensitivity analysis., Results: In the base case scenario, the WCD was less expensive compared to standard therapy. The cost-minimization analysis showed a cost reduction of €1782 per patient using the WCD. If costs of standard care were changed, cost savings associated with the WCD varied from €3500 to €0, assuming costs for standard care of €6800 to €3600., Conclusion: After ICD explantation, patients can be safely and effectively protected from SCD after hospital discharge through WCD utilization. Furthermore, the use of a WCD for this patient group is cost saving when compared to standard therapy., (© 2021 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.)